Europaudvalget 2023
KOM (2023) 0414
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EUROPEAN
COMMISSION
Brussels, 5.7.2023
SWD(2023) 414 final
COMMISSION STAFF WORKING DOCUMENT
IMPACT ASSESSMENT REPORT
Accompanying the documents
Proposal for a Regulation of the European Parliament and of the Council
on the production and marketing of plant reproductive material in the Union, amending
Regulations (EU) 2016/2031, 2017/625 and 2018/848 of the European Parliament and of
the Council, and repealing Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC,
2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90
(Regulation on plant reproductive material)
and
Proposal for a Regulation of the European Parliament and of the Council
on the production and marketing of forest reproductive material in the Union,
amending Regulations (EU) 2016/2031 and 2017/625 of the European Parliament and of
the Council, and repealing Council Directive 1999/105/EC
(Regulation on forest reproductive material)
{COM(2023) 414 final} - {SEC(2023) 414 final} - {SWD(2023) 410 final} -
{SWD(2023) 415 final} - {COM(2023) 415 final}
EN
EN
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Table of Contents
1.
2.
INTRODUCTION: POLITICAL AND LEGAL CONTEXT ............................................................... 6
PROBLEM DEFINITION .................................................................................................................. 12
2.1. What are the problems? ................................................................................... 12
2.1.1. Problem 1: Non-harmonised internal market (divergent conditions for the operators
across Member States) ............................................................................................................... 13
2.1.2. Problem 2: PRM/FRM legislation is not aligned with the objectives of the European
Green Deal and related strategies .............................................................................................. 16
2.2. What are the problem drivers? ........................................................................ 19
2.2.1. Regulatory drivers ....................................................................................................... 19
2.2.2.
2.2.3.
3.
New policy developments ........................................................................................... 20
New developments in science and technology ............................................................ 20
2.3. How likely is the problem to persist? .............................................................. 20
WHY SHOULD THE EU ACT? ........................................................................................................ 21
3.1. Legal basis ....................................................................................................... 21
3.2. Subsidiarity: Necessity of EU action ............................................................... 21
3.3. Subsidiarity: Added value of EU action .......................................................... 21
4.
OBJECTIVES: WHAT IS TO BE ACHIEVED? ............................................................................... 22
4.1. General objectives ........................................................................................... 22
4.2. Specific objectives ........................................................................................... 22
4.3. Intervention logic............................................................................................. 23
5.
WHAT ARE THE AVAILABLE POLICY OPTIONS? .................................................................... 24
5.1. What is the baseline from which options are assessed? .................................. 24
5.2. Description of the policy options .................................................................... 26
5.2.1. Measures common to all options ................................................................................. 28
5.2.2.
5.2.3.
5.2.4.
5.2.5.
6.
Option 1 - Highest flexibility ...................................................................................... 29
Option 2 - Balancing flexibility and harmonisation .................................................... 30
Option 3 - Highest harmonisation ............................................................................... 32
Stakeholders’ views on policy options ........................................................................ 36
5.3. Options discarded at an early stage and alternative measures ......................... 39
WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ........................................................... 39
6.1. Economic impacts ........................................................................................... 40
6.1.1. Common measures to policy options 1-3 .................................................................... 40
6.1.2.
6.1.3.
6.1.4.
Strengthened sustainability requirements .................................................................... 41
Official controls ........................................................................................................... 45
Conservation and sustainable use of plant and forest genetic resources ..................... 47
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6.1.5.
6.1.6.
6.1.7.
Innovation and digitalisation ....................................................................................... 48
SMEs ........................................................................................................................... 49
Competitiveness .......................................................................................................... 49
6.2. Environmental impacts .................................................................................... 50
6.2.1. Strengthened sustainability requirements .................................................................... 50
6.2.2.
Conservation and sustainable use of plant and forest genetic resources ..................... 53
6.2.3. Common measures for PRM to contribute to sustainability, biodiversity and climate-
related challenges ...................................................................................................................... 53
6.3.
6.4.
6.5.
6.6.
7.
Social impacts .................................................................................................. 54
Sustainability ................................................................................................... 54
Global combined impact of the policy options................................................ 55
Stakeholders’ views on impact of policy options ............................................ 58
Effectiveness.................................................................................................... 60
Efficiency ........................................................................................................ 62
Coherence ........................................................................................................ 63
Subsidiarity and proportionality ...................................................................... 65
HOW DO THE OPTIONS COMPARE? ............................................................................................ 59
7.1.
7.2.
7.3.
7.4.
8.
PREFERRED OPTION ...................................................................................................................... 66
8.1. REFIT (simplification and improved efficiency) ............................................ 67
8.2. Simplification and burden reduction for businesses, supporting the one-in one-
out approach .................................................................................................... 69
9.
HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................................. 69
ANNEX 1: PROCEDURAL INFORMATION ............................................................................................ 73
1.
2.
3.
4.
LEAD DG, DECIDE PLANNING/CWP REFERENCES .................................................................. 73
ORGANISATION AND TIMING...................................................................................................... 73
CONSULTATION OF THE RSB....................................................................................................... 74
EVIDENCE, SOURCES AND QUALITY......................................................................................... 76
ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) ................................................ 78
1.
CONSULTATION STRATEGY ........................................................................................................ 78
1.1. Consultation activities undertaken by DG SANTE ......................................... 78
1.2. Consultation activities conducted in the framework of the study supporting the
impact assessment ........................................................................................... 79
2.
3.
4.
STAKEHOLDER PARTICIPATION................................................................................................. 79
RESULTS OF STAKEHOLDER CONSULTATION ACTIVITIES ................................................. 81
CONCLUSIONS ................................................................................................................................. 83
ANNEX 3: WHO IS AFFECTED AND HOW? .......................................................................................... 84
1.
PRACTICAL IMPLICATIONS OF THE INITIATIVE..................................................................... 84
1.1. Operators ......................................................................................................... 84
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1.2. National competent authorities ........................................................................ 84
1.3. Users of PRM and FRM .................................................................................. 85
2.
SUMMARY OF COSTS AND BENEFITS ....................................................................................... 85
ANNEX 4: ANALYTICAL METHODS / CALCULATIONS .................................................................... 90
1.
2.
3.
4.
5.
6.
7.
8.
GLOBAL VALUE OF PRM/FRM AND COST OF PRM AS A SHARE OF TOTAL INPUT COSTS
OF AGRICULTURAL PRODUCTION ............................................................................................. 90
NUMBER OF NEW VARIETIES ...................................................................................................... 92
PRM CERTIFICATION AREAS / CERTIFIED QUANTITIES AND CERTIFICATION UNDER
OFFICIAL SUPERVISION ................................................................................................................ 93
VARIETY REGISTRATION COSTS ................................................................................................ 97
IMPACT OF STRENGTHENED SUSTAINABILITY REQUIREMENTS IN VARIETY
REGISTRATION ................................................................................................................................ 99
IMPACT OF ASSESSMENT OF SUSTAINABILITY CHARACTERISTICS OF BASIC MATERIAL
.......................................................................................................................................................... 101
INNOVATION AND DIGITALISATION ....................................................................................... 102
DETAILED PRESENTATION OF COSTS AND BENEFITS ........................................................ 103
8.1.
8.2.
8.3.
8.4.
8.5.
9.
Costs of common measures ........................................................................... 103
Benefits of common measures....................................................................... 106
Costs per option ............................................................................................. 109
Benefits per option ........................................................................................ 113
Net benefit and cost benefit analysis ............................................................. 117
REDUCTION OF ADMINISTRATIVE BURDENS DUE TO SIMPLIFICATION OF
ADMINISTRATIVE PROCEDURES .............................................................................................. 118
ANNEX 5: BACKGROUND INFORMATION ........................................................................................ 120
1.
2.
THE PRM LEGISLATION AND ITS DEVELOPMENT................................................................ 120
PRINCIPLES OF THE PRM LEGISLATION ................................................................................. 121
2.1. Variety registration ........................................................................................ 121
2.1.1. Distinctness, uniformity and stability (DUS) ............................................................ 121
2.1.2.
Value for cultivation and use (VCU)......................................................................... 122
2.2. Certification ................................................................................................... 124
2.2.1. Official certification .................................................................................................. 124
2.2.2.
Certification under official supervision ..................................................................... 125
2.3. Activities of seed conservation networks and exchange in kind ................... 126
2.4. Marketing to amateur gardeners .................................................................... 127
2.5. Organic varieties suitable for organic production and organic heterogeneous
material .......................................................................................................... 128
2.6. Conservation varieties ................................................................................... 128
3.
4.
5.
PRINCIPLES OF THE FRM LEGISLATION ................................................................................. 129
INTERACTION WITH OTHER EU POLICIES AND INSTRUMENTS ....................................... 131
INTERACTION BETWEEN FSFS, PRM/FRM AND NGTS ......................................................... 133
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6.
7.
8.
9.
INTERPLAY BETWEEN PRM/FRM AND NGT INITIATIVES AS REGARDS SUSTAINABILITY
PROVISIONS ................................................................................................................................... 133
INTERPLAY BETWEEN PRM/FRM LEGISLATION AND PHL................................................. 134
INNOVATION AND DIGITALISATION ....................................................................................... 137
OFFICIAL CONTROLS ................................................................................................................... 140
9.1. Legal analysis ................................................................................................ 140
9.2. Information on official controls from consultation activities ........................ 164
9.2.1. Controls on operators carrying out certification under official supervision.............. 164
9.2.2.
9.2.3.
9.2.4.
9.2.5.
10.
PRM import controls ................................................................................................. 164
Types of import controls: .......................................................................................... 165
Controls on operators at production stage of PRM/FRM .......................................... 165
PRM marketing controls............................................................................................ 167
FURTHER DETAILS ON OPTION 2 (PREFERRED OPTION) .................................................... 169
10.1. Current and potential future approach for variety registration and PRM
certification .................................................................................................... 169
10.2. Potential future approach for variety registration, activities of seed conservation
networks and exchange in kind of seeds ....................................................... 170
10.3. Value for sustainable cultivation and use (VSCU)........................................ 171
10.4. Certification under official supervision ......................................................... 172
10.5. Future regulation of RNQPs .......................................................................... 174
ANNEX 6: BIBLIOGRAPHY.................................................................................................................... 176
1.
2.
3.
GENERAL LITERATURE .............................................................................................................. 176
DOCUMENTS OF THE EUROPEAN COMMISSION................................................................... 179
EU LEGISLATION (OTHER THAN THAT LISTED IN SECTION 1 OF ANNEX 5) ................. 180
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Glossary
Term or acronym
BMT
CPVO
CPVR
DG SANTE
DUS
EGD
EU
F2F
FRM
FSFS
GMO
IMSOC
MS
NCA
NGT
OC
OCR
OECD
PHL
PRM
QP
RNQP
SDG
SME
SUR
TFEU
UPOV
VCU
VSCU
Meaning or definition
Bio-molecular techniques
Community plant variety office
Community plant variety rights
Directorate-General for Health and Food Safety
Distinctness, Uniformity and Stability
European Green Deal
European Union
Farm to Fork Strategy
Forest reproductive material
Framework for sustainable food system
Genetically modified organism
Information management system for official controls
Member State(s)
National Competent Authority
New genomic techniques
Official control
Official Controls Regulation
Organization for Economic Co-operation and Development
Plant health legislation
Plant reproductive material
Quarantine pest
Regulated non-quarantine pest
Sustainable Development Goal
Small and medium-sized enterprise
Proposal for a Regulation on the sustainable use of plant protection
products
Treaty on the Functioning of the European Union
International union for the protection of new varieties of plants
Value for cultivation and use
Value for sustainable cultivation and use
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1.
I
NTRODUCTION
: P
OLITICAL AND LEGAL CONTEXT
Plant reproductive material (PRM)
is any plant material (for example seeds, tubers, cuttings,
rootstocks, seedlings, young plants, fully grown trees) that is used for the reproduction of other
plants.
Forest reproductive material (FRM)
is the PRM of tree species that is used for the
creation of new forests, the reforestation of existing ones and other tree planting activities (for
example, in rural areas for the purpose of climate adaptation). Thus, PRM and FRM form the
starting point of agricultural and food production and forestry, respectively. In particular, the
availability of, and access to, high-quality PRM are key contributors to food security. They link to
the four main pillars on which food security is based: availability, access, utilisation and stability
1
.
The actions taken under the Farm to Fork Strategy (F2F) including those under this initiative will
help enable and contribute to the transition to sustainability, which will strengthen resilience and in
turn enhance short- and long-term food security. The availability of and access to high-quality and
genetically diverse FRM will contribute to more sustainable afforestation and reforestation which
will in turn strengthen the resilience of forest ecosystems and ensure that forests can adapt to
climate change.
The EU legislation on PRM and FRM currently includes 12 basic Directives, collectively known as
‘marketing Directives’: 10 specific for each type of crop (seed of cereals, seed of fodder plants,
seed of oil and fibre plants, seed of beet, seed potatoes, vegetable seed, vegetable reproductive
material other than seed, fruit plants, vine, ornamental plants), one Directive establishing the
Common Catalogue of varieties of agricultural species and one on FRM (for a detailed overview
see Annex 5, Section 1). The oldest of these Directives date back to 1966
2
. The legislation applies
to the economically most important plant species. The aim of this legislation is to ensure the
identity, quality and health of the marketed PRM and FRM for its users.
The
PRM legislation
has two main pillars: registration of varieties
3
and certification of PRM
(Annex 5, Section 2). For the purposes of
variety registration,
the candidate varieties are tested in
field trials for their
distinctness, uniformity and stability (DUS)
4
by the National Competent
Authority (NCA) of the MS where the application is submitted. DUS tests take two to three years in
the case of varieties of agricultural plant species
5
and vegetable species and five to six years in the
case of varieties of fruit plants and vine. For agricultural plant species the candidate varieties are
also assessed by comparative field trials carried out by the NCAs for their
value for cultivation
and use (VCU),
i.e. whether they offer a clear improvement in performance compared to reference
varieties. Upon satisfactory completion of the DUS, and where applicable of the VCU examination,
varieties are registered in the national catalogue of the MS and subsequently notified to the
1
2
FAO (2022).
A compilation of the legislation can be found at
https://food.ec.europa.eu/plants/plant-reproductive-
material/legislation/specific-legislation_en.
See also Section 1 of Annex 5.
3
A plant variety represents a group of plants of a given species with a common set of characteristics, while a plant
species can include from a few to thousands of different plant varieties. PRM (seed, cuttings etc.) is marketed with
reference to a registered variety.
4
New varieties need to be different from other known (reference) varieties (distinctness requirement). The
characteristics of different plants within the same variety should be similar (uniformity requirement). The
characteristics of the plants of a new variety should not change over time (stability requirement).
5
The term ‘agricultural plant species’ is referring collectively to cereals, fodder plants, beet, potato, oil and fibre plants.
6
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corresponding EU Common Catalogue for marketing throughout the EU. Each registered plant
variety is designated a unique denomination, i.e. a name that serves to identify that variety.
Certification of PRM
consists of checks (both in the field where PRM is produced, by sampling
and testing the PRM lots produced and control plot testing of the varietal identity) to verify its
identity, quality and health.
As regards identity, it is verified that the PRM has the same
characteristics as the registered plant variety to which that PRM belongs (i.e. it is true to variety
description). Different marketing categories of PRM are defined depending on the quality and
technical requirements (e.g. analytical purity, germination rate, absence of weeds). As regards
health, it is verified that the PRM does not contain any plant pests or diseases. Certain aspects of
the certification procedures can be carried out by authorised operators under the
official
supervision
of the NCAs. For PRM that meets the certification requirements the NCAs issue an
official label with which the PRM can be marketed throughout the EU
6
. The PRM legislation
furthermore includes rules for marketing of PRM in homogeneous lots with reference to a lot
number to assure traceability, as well as rules for packaging, sealing, labelling and documentation.
The PRM legislation also sets the rules for imports of PRM into the EU. Such PRM can only be
marketed in the Union if it satisfies the same requirements as the material produced and certified
within the Union (EU equivalence regime). Exports are not covered by the legislation. Finally, to
ensure the quality of PRM marketed throughout the EU, NCAs should carry out
official controls
(OCs) in order to verify compliance with the rules on the production, marketing and imports of
PRM.
The
FRM legislation
is based on principles quite different from those of the PRM legislation, as
FRM differs significantly from PRM (Annex 5, Section 3). While seeds of agricultural crops are
harvested in annual cycles, for certain forestry species it takes 50-100 years before FRM can be
harvested. FRM is marketed in relation to basic material (i.e. approved trees from which seed is
harvested) and provenance (the place in which trees are growing). NCAs approve basic material
through an official inspection following which basic material is registered in the national catalogue
of the MS and subsequently in the EU Common Catalogue FOREMATIS
7
. Upon harvesting seeds
and other FRM from basic material, NCAs issue a master certificate. FRM has to meet the relevant
requirements (age, development, health and resistance of trees in stands to adverse climatic
conditions) before the operator can issue a supplier’s document or supplier’s label. The registration
of basic material, the master certificate and the supplier’s document/label are prerequisites for the
marketing of FRM throughout the EU. Similar to the PRM legislation, the FRM legislation also
includes rules for marketing of FRM, imports (equivalence), derogations aiming to facilitate the
conservation and sustainable use of forest genetic resources, and OCs for verifying compliance with
the rules on the production, marketing and imports of FRM.
The
EU PRM and FRM market
has an estimated annual value of over EUR 13 billion
8
. As
regards the seed sector in particular, the EU is in the top three of globally exporting regions. The
EU seed market covers agricultural species (e.g. wheat, maize, rice), vegetable species (e.g. tomato,
carrot, lettuce). It is the third largest seed market after the USA and China and accounts for around
6
Ornamental plants are an exception to the general approach described above. There is no obligation for registration of
varieties and the PRM is subject only to basic requirements as regards health, vigour and germination.
7
Forest Reproductive Material Information system (http://ec.europa.eu/forematis).
8
Eurostat, see Annex 4 Section 1.
7
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20% of the global market, estimated at EUR 7-10 billion (revenues from commercial seed sales, not
including farm-saved seeds). There is little information available on the structure of the seed sector
in the EU. The number of companies in the seed sector is about 7 000. They are very diverse in
terms of size (turnover, employees), crops or geographical area covered. They may be active in one
or several stages of the seed industry: plant breeding, seed production, seed conditioning, and seed
marketing and distribution. The number of small and medium-sized enterprises (SMEs) is assumed
to be high, but no information is available on their market share. Furthermore, it is not known how
many are independent (a single company may own a large number of brands), while cross-licensing
and cooperation agreements have created a network of relationships between seed companies that
make the mapping of the sector extremely difficult
9
. The EU plant breeding sector is highly
innovative and new varieties are constantly developed to meet the demands of farmers, industry and
consumers. It spends around 15% of its annual turnover on research and development
10
. Farmers
also play an important role in the seed sector as they multiply the seed of agricultural plant species
in their fields on behalf of the seed companies. In 2021 the area used for production of certified
seed (vegetable and ornamental seeds not included) in EU amounted to slightly more than 2 million
ha
11
. As regards PRM of fruit plants, there are over 20 000 suppliers in the EU, almost all of which
are SMEs
12
. As regards FRM, there are over 4 000 suppliers in the EU, almost all of which are
SMEs
13
. The overwhelming majority of FRM (tree seeds and plants) are marketed within the EU
and only a minority is traded with non-EU countries
14
.
Relationship with other EU policies and instruments
The PRM/FRM legislation interacts with a number of
EU policies and instruments
(Annex 5,
Section 4). There is a close link with the European Green Deal (EGD)
15
and its related strategies:
F2F
16
recognises that sustainable food systems rely on seed security and diversity and that
farmers need to have access to a range of quality seeds for plant varieties adapted to the
pressures of climate change. The initiative for the PRM/FRM revision will introduce relevant
considerations in the criteria for acceptance of new varieties. It will also contribute to reaching
the F2F objective of at least 25% of the EU’s agricultural land under organic farming by 2030
by introducing rules on registration of organic varieties suitable for organic production adapted
to the needs of organic production.
The initiative for the PRM/FRM revision will contribute to the objective of the EU Biodiversity
Strategy for 2030
17
to reverse the decline of genetic diversity by facilitating the market access
9
Ragonnaud G. (2013).
Bakker T.
et al.
(2012).
11
European Seed Certification Agencies Association (ESCAA) Seed production in EU - 2021 (escaa.org). This area
corresponds to about 1% of the total utilised agricultural area in EU. The number of farmers involved is unknown,
indicatively in France about 17 900 farmers are involved in seed multiplication (semae.fr).
12
Data collected from the NCAs. The existence of in total 20 137 suppliers of PRM of fruit plants were reported by the
NCAs from 10 MS.
13
Data collected from the NCAs. The existence of in total 4 129 suppliers of FRM were reported by the NCAs from 8
MS.
14
Information from the NCAs.
15
COM(2019) 640 final.
16
COM(2020) 381 final.
17
COM(2020) 380 final.
10
8
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for traditional and locally adapted varieties, thus contributing to the conservation and
sustainable use of plant genetic resources.
It will also contribute to the objective of the EU Strategy on Adaptation to Climate Change
18
to
help farmers and land managers tackle climate risks. Relevant criteria will be introduced in the
rules for the registration of new varieties and of FRM with a view to facilitate the broadening of
the supply of suitable high-quality plant reproductive material to support adaptation in
agriculture, forestry, and land ecosystem management.
It will furthermore contribute to the objectives of the EU Forest Strategy
19
for adapting forests
to climate change and restoring forests following climate damages by introducing measures
promoting the production of FRM suitable for future climatic conditions. It will finally
contribute to meeting the target of planting at least 3 billion additional trees in the EU by 2030,
by revising the scope of the FRM legislation, in order to ensure that FRM of high quality will
be used for this.
There are also links and interplays with other EU legislation, notably the Plant Health Legislation
(PHL)
20
, the Official Controls Regulation (OCR)
21
, the Organic Regulation
22
, the Community Plant
Variety Rights (CPVR) legislation
23
and the genetically modified organisms (GMO) legislation
24
as
well as the EU Digital Strategy
25
. The PRM/FRM legislation also has to be aligned or interrelates
with a number of international standards or agreements
26
.
Relationship with other ongoing initiatives
The initiative for the revision of the PRM/FRM legislation is linked to the following ongoing
initiatives (for details see Annex 5, Section 5):
The
Framework for Sustainable Food System (FSFS) initiative
27
aims to introduce an
overarching, horizontal legal framework (‘lex
generalis’)
establishing common sustainability
principles and objectives for all food system related policies. The initiative for the PRM/FRM
revision, which is underpinned by sustainability as an objective, will include specific rules for
the PRM/FRM sectors (‘lex
specialis’).
FSFS will ensure the benefits of an integrated policy
perspective and approach, while specific requirements introduced by the PRM/FRM initiative
will accelerate the transition towards more sustainable practices in the PRM/FRM sectors.
18
19
COM(2021) 82 final.
COM(2021) 572 final.
20
Regulation (EU) 2016/2031. OJ L 317, 23.11.2016, p.4.
21
Regulation (EU) 2017/625. OJ L 95, 7.4.2017, p. 1.
22
Regulation (EU) 2018/848. OJ L 150, 14.11.2020, p.1.
23
Council Regulation (EC) No 2100/94. OJ L 227, 1.9.1994, p. 1.
24
Directive 2001/18/EC. OJ L 106, 17.4.2001, p. 1. Regulation (EC) No 1829/2003. OJ L 268, 18.10.2003, p. 1.
25
COM(2021)118 final - The EU's digital strategy aims to make the transformation to digital technologies work for
people and businesses, while helping to achieve its target of a climate-neutral Europe by 2050. Allowing the use of
digital technologies will help creating future proof PRM and FRM sectors.
26
Notably the OECD Seed Schemes for the Varietal Certification of Seed (https://www.oecd.org/agriculture/seeds/),
OECD Scheme for the Certification of Forest Reproductive Material (https://www.oecd.org/agriculture/forest/), the
International Convention for the Protection of New Varieties of Plants (UPOV), the International Rules for Seed
Testing of the International Seed Testing Association (ISTA), the United Nations Economic Commission for Europe
(UNECE) Standard for Seed Potatoes, the International Treaty on plant genetic resources for Food and Agriculture
(ITPGRFA).
27
https://food.ec.europa.eu/horizontal-topics/farm-fork-strategy/legislative-framework_en
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The
New Genomic Techniques (NGT) initiative
28
concerns plants produced by genetic
modification, in particular targeted mutagenesis
29
and cisgenesis
30
. These plants may contribute
to the innovation and sustainability objectives of the EGD and of the F2F and Biodiversity
strategies. The initiative aims at a proportionate regulatory oversight better adapted to NGTs
that combines high levels of safety with clear benefits to society and the environment.
Coherence will be ensured between the PRM/FRM and NGT initiatives, in particular as regards
any sustainability aspects (see Annex 5, Section 6). The plant variety registration system of the
PRM legislation applies to all varieties irrespective of the breeding technique. A variety
obtained by genetic modification and subject to the provisions of the GMO legislation can only
be registered and PRM of such variety can only be marketed if this variety complies with the
requirements of the GMO legislation
31
. The same applies for FRM consisting of GMOs.
Varieties and FRM with NGT traits
32
will be treated under PRM and FRM legislation in the
same way as all other varieties and FRM regardless of the breeding methodology (conventional
breeding, NGTs, established genetic modification techniques).
The
sustainable use of plant protection products (SUR)
33
initiative
aims to reduce the use
and risk of chemical pesticides. Current VCU rules (examination for resistance to plant pests
and diseases) and the envisaged measures to extend these (Section 5) contribute to this objective
of the SUR, as new varieties with increased resistance to plant pests may require less pesticides.
Legislative context
The PRM and FRM legislation was first evaluated in 2008
34
. In 2013, the Commission adopted a
proposal for its revision
35
(‘2013 PRM proposal’) accompanied by an impact assessment
36
. That
proposal was rejected by the European Parliament in 2014
37
as according to the European
Parliament, one Regulation could not address the requirements of the broad range of PRM and
cover FRM. The European Parliament also had concerns regarding the marketing to amateur
gardeners, the unnecessary burden on operators and NCAs and insufficient biodiversity provisions.
Subsequently, the proposal was withdrawn by the Commission in 2015
38
.
Following a request by the Council
39
, the Commission presented in 2021 a study on the Union’s
options to update the existing legislation on the production and marketing of plant reproductive
28
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-for-plants-produced-by-
certain-new-genomic-techniques_en
29
Targeted mutagenesis is an umbrella term used to describe newer techniques of mutagenesis that induce mutation(s)
in selected target locations of the genome without insertion of foreign genetic material.
30
Cisgenesis means the insertion of genetic material (e.g. a gene) into a recipient organism from a donor that is
sexually compatible (crossable).
31
Directive 2001/18/EC and Regulation (EC) No 1829/2003.
32
In genetics a trait is a specific characteristic. NGT traits are modified traits obtained by targeted mutagenesis and
cisgenesis.
33
COM(2022) 305 final.
34
FCEC (2008).
35
COM(2013) 262 final.
36
SWD(2013)162 final.
37
European Parliament legislative resolution of 11 March 2014 (COM(2013)0262 — C7-0121/2013 —
2013/0137(COD)). OJ C 378, 9.11.2017, p. 303–303.
38
Withdrawal of Commission proposals (2015/C 80/08). OJ C 80, 7.3.2015, p. 17–23.
39
Council Decision (EU) 2019/1905.
10
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material (‘PRM study’)
40
, which was supported by an external data gathering study
41
. In 2022
another external study
42
was undertaken in support of this impact assessment.
All concerns expressed by the European Parliament on the 2013 PRM proposal are addressed by
this initiative (Table 1). The context has changed to the degree that the issues identified in 2013 are
even more actual, e.g. need to modernise the legislation to allow for new technical developments,
increasing demand for sustainability in agriculture, adaptation to climate change and conservation
of agro-biodiversity. These issues are also relevant in view of the new political objectives.
Concerns expressed by the European Parliament on the
2013 PRM proposal
“One size fits all” approach does not meet the different
requirements of different PRM, operators, consumers and
authorities.
Approach taken in this initiative
Two different proposals will be adopted, one on PRM
and the other on FRM. The PRM proposal addresses
crop-specific issues with separate sections and annexes
for seeds and for other plant reproductive material. The
PRM of ornamental plants will remain separately
regulated by the current Directive 98/56/EC that will be
kept in place.
Empowerments are considered only where there is the
need to maintain flexibility to adapt the technical
requirements
to
scientific
and
technological
developments.
Measures on PRM and FRM have been considered
separately. There will be two different proposals, one
on PRM and one on FRM.
The PRM of ornamental plants will remain separately
regulated by the current Directive 98/56/EC that will be
kept in place.
Lighter requirements for marketing to amateur
gardeners have been considered, on the basis on the
results of the consultation while ensuring quality of
PRM.
The Better Regulation guidelines for the preparation of
the impact assessment have been respected.
CPVO’s role is limited to the extent necessary (audits of
NCAs on DUS and denomination checks).
Improved legal drafting and simplification of
procedures.
Significant number of delegated and implementing acts
make it difficult to properly assess the future impact of the
regulation.
FRM is a specific sector that should not be covered by the
same legislation as with other PRM.
Concerns in relation to PRM for ornamental purposes.
Concerns in relation to PRM intended for sale to home
gardeners.
Concerns regarding poor quality of the impact assessment.
Concerns in relation to extended remit for the CPVO.
Vague definitions and unnecessary administrative burden
placed on the Member States.
40
41
SWD(2021)90 final.
ICF (2021).
42
ICF (2023).
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Need to facilitate and encourage the maintenance of
biodiversity in agriculture and horticulture.
A number of new approaches (lighter rules on
conservation varieties, new locally adapted varieties and
heterogeneous material, rules for organic varieties
adjusted to the needs of organic production) will
contribute to the conservation and sustainable use of
plant genetic resources and the increase of the genetic
diversity of cultivated crops.
Table 1. Overview of concerns expressed by the European Parliament in 2014 and approach taken in this initiative to
address them.
2.
P
ROBLEM DEFINITION
2.1.
What are the problems?
The PRM/FRM legislation has gradually evolved over several decades since the introduction of the
first marketing Directives in the 1960s. The long history of amendments has led to a complex,
incoherent and fragmented legal framework that is not up to date with the current scientific and
technical developments. For certain aspects, such as the implementation of derogations and OCs, it
leaves too much room for interpretation, resulting in divergent implementation across MS, thus
hindering the internal market. Furthermore, the complexity and rigidity of the procedures puts a
high burden on NCAs and operators alike. The basic legislation includes detailed technical
requirements, making it difficult to adapt the system to new policy priorities, as well as to new
developments in science and technology and demands for more sustainable agri-food production
and forestry.
Figure 1. Problem tree
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Development of the problems since 2013:
The 2008 evaluation and the 2013 impact assessment already identified most of these problems.
Although no full-fledged evaluation of the PRM legislation was carried out after 2008, two
evaluative studies were carried out. In 2021, there was an external data gathering study
43
supporting
the PRM study that was requested by the Council and in 2022 another external study
44
supporting
this impact assessment. The analysis and evidence of the existing problems was considered
comprehensive, and the problems remain valid. The results of the feedback received on the
inception impact assessment in 2021, and of extensive consultations activities have confirmed the
problems and provided further elements to substantiate them.
However, in comparison to 2008 and 2013 the overall context has changed significantly as the EGD
and its related strategies have put a stronger focus on sustainability, climate change adaptation and
biodiversity. Other related legislation (PHL
45
, OCR, Organic Regulation
46
) has evolved and there
have been new scientific and technological developments. Individual Directives have undergone a
high number of targeted amendments in certain articles to address specific issues and to keep pace
with these developments
47
. Furthermore, seven out of 11 Directives have been recast (Annex 5,
Section 1). However, the majority of the provisions in the Directives have never been revised in a
coherent and systematic way. Additionally, MS have adopted their own solutions in relation to new
developments not covered by the legislation
48
. These scattered approaches have exacerbated the
problems of incoherence between the different Directives and further increased their overall
complexity.
2.1.1.
Problem 1: Non-harmonised internal market (divergent conditions for
the operators across Member States)
Implementation of various aspects of the legislation and therefore
conditions for operators and
marketed PRM and FRM differ between Member States (MS),
either because the legislation is
unclear and leaves room for interpretation, or MS tried to find practical solutions to overcome rigid
provisions and provisions that have not followed in a timely manner new developments in science
and technology.
The provisions in the marketing Directives on OCs
49
for verification of compliance with the
requirements of the legislation are quite vague and do not specify minimum requirements
50
. PRM
43
44
ICF (2021).
ICF (2023).
45
For example, under the new PHL the plant passport covers compliance with the requirements for RNQPs. It is
therefore no longer possible to regulate RNQPs only in the framework of the PRM/FRM certification, a solution
considered in the 2013 IA.
46
The Organic Regulation has introduced new categories of “organic varieties suitable for organic production” and
“organic heterogeneous material” (Annex 5, Section 2.5).
47
For example, Commission Implementing Directive (EU) 2021/971 introduced the use of BMTs in certification but
only for agricultural plant species. Other uses (e.g. DUS, marketing controls) and other species are not covered by the
legislation. Commission Implementing Directive (EU) 2022/1647 and 2022/1648 introduced derogations as regards
DUS for the acceptance of “organic varieties suitable for organic production” for a few vegetable and agricultural plant
species but the PRM legislation does not include a comprehensive approach for such varieties
48
For example, the use of BMTs.
49
OCs are carried out during the production and marketing of PRM in the EU and the import of PRM/FRM from third
countries.
13
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imported from third countries needs to fulfil the same requirements as PRM produced in the Union
pursuant to Union rules, but there is no harmonised framework for OCs establishing the place of
those OCs (at the border control post
51
or the final point of destination) and the approach (random
or risk-based OCs). MS have implemented import controls in a different way and as a consequence
it is easier to import PRM in some MS compared to others. There are also differences between MS
as regards
OCs and enforcement
related to marketed PRM and FRM
52
. All operators are affected
by those inconsistent and unsystematic controls and enforcement that undermine the functioning of
a competitive market and increase the likelihood of lower quality PRM and FRM on the market.
Differences in controls and enforcement regarding Union regulated non-quarantine pests
(RNQPs)
53
have an impact on all operators
54
producing and marketing PRM. Those difference arise
because RNQPs are regulated both under the PHL
55
and under the marketing Directives as part of
the certification requirements (Annex 5, Section 7). Those two frameworks are not fully coherent,
as any amendments of PHL and the marketing Directives are not simultaneous. Furthermore, the
PHL falls under the scope of the OCR
56
while the marketing Directives do not. Where measures on
RNQPs of fruit plants and vine are regulated under the marketing Directives
57
while the RNQPs are
listed in the PHL
58
, there is uncertainty as to whether RNQPs fall under the scope of the OCR
(Annex 5, Section 7). The OCs on the deliberate release into the environment of Genetically
Modified Organisms (GMOs) for the purpose of food and feed production falls under the scope of
OCR and includes the presence of GMOs in PRM. OCs on PRM containing GMOs fall under the
scope of the OCR while the identity and quality controls on that PRM in the frame of the PRM
legislation are not under the OCR. This results in the doubling of OCs on the same material and
subject to different approaches. This situation leads to uncertainty for all MS and operators about
which legislation to adhere to
59
and consequently to differences in implementation and conditions
for the operators, that could eventually undermine enforcement and the quality of controls.
50
51
See for example Article 19(1) of Council Directive 66/402/EEC.
Border control posts are the places designated by MS for the performance of OCs at first arrival into the Union and
on each consignment of certain categories of goods (i.e. in contrast to OCs performed at the place of destination).
52
ICF (2021) Section 4.1.6 and ICF (2023) Section 2.1. For example, while documentary checks form the largest
proportion of OCs in all MS, there is a huge variation between MS as regards the proportion of the inspected
PRM/FRM subjected to visual inspections and to sampling and testing (ranging from 0% to 100%). In relation to
import controls there are big differences between MS in relation to the percentage of consignments subjected to official
controls (ranging from less than 10% to more than 75%).
53
RNQPs are defined in Article 36 to Regulation (EU) 2016/2031. The definition of RNQP includes the following
elements: It has a taxonomic identity. It is present in the Union territory. PRM/FRM is the main pathway for spreading
of RNQPs. The presence of an RNQP on PRM/FRM has an unacceptable economic impact on the intended use of that
PRM/FRM.
54
About 7 000 operators in seed sector and over 20 000 suppliers of PRM of fruit plants across the EU.
55
Commission Implementing Regulation (EU) 2019/2072.
56
Article 2, point (g) of Regulation (EU) 2017/625.
57
This is the case for fruit plants under Commission Implementing Directive 2014/98/EU and Implementing Directive
2008/90/EC and for vines under Council Directive 68/193/EEC.
58
Additionally, PHL includes requirements on Quarantine Pests (QPs).
59
ICF (2021) Section 4.1.5 and targeted survey of NCAs in the context of ICF (2023).
14
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The VCU examination for variety registration can only be carried out officially, but in order to
overcome the limitations in resources
60
a few NCAs have introduced their own practices for taking
into account breeders’ data
61
, leading to a divergence in the conditions for operators across MS
62
.
Absence of common rules on
recent scientific and technical developments,
namely innovative
production processes, bio-molecular techniques (BMTs)
63
and digitalisation
64
, has resulted in
operators not being able to market certain PRM/FRM produced by innovative processes (e.g. true
potato seed
65
, the fruit plants and vine marketing Directives do not include rules for the certification
of selected clones). For FRM, clones produced by
in vitro
propagation the current rules do not
ensure traceability, because the legislation does not require reference to the production place of the
clones. As regards BMTs, MS increasingly adopt national approaches (Annex 5, Section 8). For
example, in Spain the use of BMTs is allowed as a self-standing tool for the identification of
varieties during marketing controls without the need for observing the phenotypic characteristics of
the varieties during control plot testing
66,67
. This leads to divergent conditions for operators across
MS as well as to missed opportunities to increase the efficiency of processes and competitiveness
of the PRM/FRM sectors
68
Furthermore, the absence of such rules at EU level leads to the
divergence of the EU legislation from international standards where such advances are already
catered for (e.g. International Union for the Protection of New Varieties of Plants (UPOV)
69
,
Organization for Economic Co-operation and Development (OECD) Seed Schemes).
60
The examination for variety registration (DUS and VCU where applicable, with DUS and VCU done in parallel)
depending on the species last at least two years. This period cannot be reduced as these examinations require growing
the plants in the field. Implementation of DUS is standardised across the MS (based on the application of CPVO
protocols for CPVR) while for VCU only four general characteristics are laid down. There are also differences between
the MS as regards VCU costs (attributed mostly to differences in wages) and duration of VCU (for a given species
some NCAs may perform VCU 1 year longer than others, difference attributed mostly to the relative importance of the
species in the given MS), FCEC(2010) and ICF (2021).
61
Before submitting an application for official registration of a new variety, breeders already test that variety for a
number of desirable characteristics.
62
Outcome of targeted survey of NCAs in the context of ICF (2023).
63
BMTs have the potential to increase efficiency by shortening variety registration (PRM) and provenance trials
(FRM). BMTs also have the potential to support marketing controls to check the identity of varieties, by supplementing
visual inspection and control plot testing in the field.
64
Currently the legislation implies that labels are physical. Digitalisation has the potential to improve the efficiency and
integrity of the certification and labelling system and to address the increased risk of fraud in the seed sector caused by
increasing volumes of seed lots being traded internationally.
65
The marketing Directive on seed potatoes is restricted to vegetative propagation with potato tubers (= asexual
reproduction), therefore it does not cover the use of true potato seeds, i.e. botanical seed (= sexual reproduction). The
legislation on fruit plants and FRM lacks specific provisions for the use of
in vitro
propagation (process whereby PRM
and FRM are produced in the laboratory under sterile conditions).
66
Article 30 to Real Decreto 929/1995, de 9 de junio, por el que se aprueba el Reglamento técnico de control y
certificación de plantas de vivero de frutales. «BOE» núm. 141, de 14/06/1995.
67
PLAN NACIONAL DE CONTROL Y CERTIFICACIÓN DE PLANTAS DE VIVERO DE FRUTALES PARA EL
AÑO
2017.
MINISTERIO
DE
AGRICULTURA,
ALIMENTACIÓN
Y
MEDIO
AMBIENTE.
https://www.mapa.gob.es/es/agricultura/temas/medios-de-
produccion/plannacionaldecontrolycertificaciondeplantasdevivero2017_tcm30-552931.pdf
68
ICF (2021) Section 4.2.
69
UPOV (2020).
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2.1.2.
Problem 2: PRM/FRM legislation is not aligned with the objectives of
the European Green Deal and related strategies
This problem concerns restrictions in relation to genetic diversity of PRM/FRM, insufficient
sustainability considerations and incomplete scope of the FRM legislation. In the case of PRM,
more genetically diverse varieties (e.g. conservation and organic varieties) cannot meet the existing
legal requirements for variety registration. The activities of seed conservation networks and
exchange in kind of seed are subject to the current rules on variety registration. There is an
insufficient supply of high-quality certified FRM due to the increasing demand for FRM for non-
forestry purposes
70
. The increasing occurrence of extreme weather and disasters in combination
with an insufficient assessment of sustainability characteristics in the registration of new varieties
and of FRM put pressure on the stability of yield in the PRM sector and on the supply of suitable
FRM and thus on the resilience of agri-food production and forestry.
First, the current variety registration system based on DUS limits the acceptance and therefore the
access to the market of less uniform and more genetically diverse varieties. Such varieties are
desirable for
organic production
71
and other low input agricultural systems. They could contribute
to more diverse agri-food systems, in particular at local level and broaden the genetic reservoir of
cultivated crops
72
but are currently restricted due to the DUS requirements. The demand for organic
seed in the EU vastly exceeds the supply (though with variations between the different regions and
crops), resulting in a high use of derogations for untreated conventional seeds despite that these
derogations are phased out by 2036 under the Organic Regulation. In the absence of sufficient
quantities of certified organic seed, the use of untreated conventional seed in organic farming
ranges between 18% in Central Europe and 48% in Eastern Europe
73
. The problem concerns all
breeders active in the breeding of organic varieties, since those varieties have difficulties to access
the market
74
as well as the organic farms across the EU. There are about 244 000 farms in the EU
that have some organic area, two-thirds of which are fully organic. In 2018 the total area under
organic production in the EU was 13 million hectares or 8% of the total utilised agricultural area
75
.
The problem also undermines the effort to reach the objective under F2F of at least 25% of the
EU’s agricultural land under organic farming by 2030.
The variety registration system has a restrictive impact on activities that are important for the
conservation and sustainable use of plant genetic resources
and help in addressing the
biodiversity and climate change challenges. Seed conservation networks
76
aim to conserve
70
Non-forestry purposes comprise agroforestry, plantations for biomass production and the EU target of planting 3
billion additional trees by 2030.
71
According to the principles of the Organic Regulation, for the production of organic varieties suitable for organic
production, the organic breeding activities shall be conducted under organic conditions and shall focus on enhancement
of genetic diversity, reliance on natural reproductive ability, as well as agronomic performance, disease resistance and
adaptation to diverse local soil and climate conditions. However, currently the biggest share of PRM for organic
varieties marketed in the EU are varieties accepted under the DUS rules (Euroseeds (2019)), i.e. they are characterised
by high uniformity contrary to the abovementioned principles.
72
FAO (1997).
73
Solfanelli F.
et al.
(2022).
74
The number of those breeders in EU is unknown.
75
Eurostat (2020).
76
There is no accurate information on the number of such networks in EU, nor on the number of varieties or accessions
that they maintain. Indicatively, DIVERSIFOOD (2017a) collected via a survey information on 80 such initiatives
16
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threatened varieties
77
and prevent genetic erosion
78
, while for addressing particular local needs new
locally adapted varieties
79
are bred
80
. However, most often conservation and new locally adapted
varieties either do not meet the variety registration requirements (DUS) or the quantities of PRM
are so low that it is unfeasible to benefit from the existing derogations for conservation varieties
81
.
Due to these restrictions the availability of such varieties in the public domain often relies on
exchange in kind of seed
82,83
, which is currently not possible as it is covered by the definition of
“marketing” within the Directives
84
and therefore requires the fulfilment of variety registration and
certification requirements (Annex 5, Section 2.2). Exchange in kind of seeds between farmers is
currently also restricted by these requirements, although an important number of small farmers
across EU save and exchange seed from their harvest, because such seed is better adapted to their
local environment conditions following ongoing on-farm selection over many years. Indicatively,
one of the organisations advocating for a framework for seed exchange between farmers counts
over 80 000 members across EU. These restrictions also affect all operators
marketing to amateur
gardeners
(Annex 5, Section 2.4) with the vast majority of PRM marketed to amateur gardeners
belonging to registered varieties, leaving the demand for locally adapted varieties unsatisfied
85
. The
derogations to the rules for acceptance of varieties and certification of seeds for agricultural and
vegetable conservation varieties
86
have had some results
87
but the requirements are still considered
too burdensome
88
. Furthermore, these derogations do not cater for new locally adapted varieties.
MS currently have the possibility to accept conservation varieties on the basis of an official DUS
examination, or an official DUS examination with increased tolerance for reduced uniformity or on
the basis of other information such as historical knowledge. This leads to different conditions for
operators between the MS. For example, Czechia carries out DUS, Spain carries out DUS but
across the EU. Most of them manage between 100 to 1 000 samples each. Number of members varies from a few to
hundreds. The survey also identified that there are probably many more initiatives across the EU than those that
responded.
77
Conservation can be done
in situ
at the existing location (i.e. in the farmed environment in the case of cultivated plant
species and forest genetic resources in forests) or
ex situ
in gene banks.
78
Genetic erosion is the loss of genetic diversity between and within populations or varieties of the same species over
time, or reduction of the genetic basis of a species due to human intervention or environmental change (Article 2(b) of
Commission Directive 2008/62/EC).
79
Lack of improved varieties suitable for marginal areas led to breeding of such varieties, which are typically quite
heterogeneous in order to withstand particular conditions. Usually bred under participatory plant breeding, whereby
breeders, researchers, farmers and other stakeholders work together.
80
This is reflected also in the eligible types of intervention in CAP Strategic Plans under Regulation (EU) 2021/2115
81
Exemption from DUS and certification requirements under Directives 2008/62/EC and 2009/145/EC. See also Annex
5, Section 2.6.
82
DIVERSIFOOD (2017b).
83
Exchange in kind of seed means the transfer of seed from one farmer to another farmer. See also Annex 10 of ICF
(2023).
84
Marketing is defined in the Directives as ‘the
sale, holding with a view to sale, offer for sale and any disposal, supply
or transfer aimed at commercial exploitation of seed to third parties, whether or not for consideration.’
85
ICF (2021) Section 4.5.
86
Conservation varieties according to Commission Directives 2008/62/EC and 2009/145/EC are landraces and varieties
which have been traditionally grown in particular localities and regions and threatened by genetic erosion. Landrace
means a set of populations or clones of a plant species which are naturally adapted to the environmental conditions of
their region.
87
At the end of 2021, there were 396 conservation varieties of agricultural plant species and 177 of vegetable species
registered in the Common Catalogues (representing around 1% of the total number of registered varieties).
88
ICF (2021) Section 4.6.
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accepts uniformity levels of 90%, Germany accepts a variety description by applicant but carries
out a DUS examination in case of doubt
89
.
Second, the current PRM/FRM rules have only a
limited contribution to sustainable production.
Those provisions are restricted to varieties of agricultural species (VCU)
90
in the case of PRM and
the higher FRM categories
91
. Similar requirements to VCU are in place for vine under the DUS
examination
92
. Currently no such provisions exist for vegetable species and fruit plants. The PRM
legislation prescribes four broad criteria that must be examined in VCU testing leaving the degree
to which sustainability is addressed at the discretion of the MS, thus implying that new varieties can
be registered without improved performance regarding sustainability characteristics
93
.
Likewise, the FRM legislation prescribes two broad sustainability characteristics (adaptability of
basic material to ecological conditions, and health and resistance of basic material to adverse
climatic conditions), leaving room for manoeuvre to MS for their implementation
94
. Some MS (e.g.
Estonia, France, Finland, France and Germany) have invested in tree breeding programmes to
ultimately improve the sustainability of the resulting FRM. Others have paid little attention to this
aspect
95
despite forests being under pressure because of climate change. This situation is inadequate
for rapidly changing conditions.
Potentially all farmers and foresters in the EU (over 5 million specialist crop farms and over 500
000 persons employed in the forestry and logging sector
96
) are at risk of not having PRM and FRM
suitable for future challenges and subsequently of facing increased losses of production. The
consequences will be equally detrimental for the wider society in terms of reduced food security
and other indirect impacts on sectors relying on agriculture and forestry. The magnitude of the
problem is already very significant. Over the period 1981-2010, the average annual crop losses
caused by drought in the EU have been estimated at EUR 4.8 billion/year
97
. However, in 2018 and
2019 in Germany alone extreme drought and heat events have caused losses in agriculture of EUR
7.8 billion, including direct losses of EUR 4.4 billion across all crops (especially wheat and potato)
and indirect losses of EUR 3.4 billion. Losses in forestry were EUR 17.8 billion, including losses of
forestry companies of EUR 8.5 billion, indirect costs of EUR 2.8 billion from CO
2
release from
89
90
Information collected by the survey under ICF(2019).
Some sustainability aspects are included in the VCU examination of candidate varieties of agricultural plant species.
91
Qualified and tested material.
92
For the purpose of simplicity, the field trials carried out to meet these VCU-like requirements for vine will also be
referred to as VCU.
93
Those criteria are currently defined as “1. Yield; 2. Resistance to harmful organisms; 3. Behaviour with respect to
factors in the physical environment; 4. Quality characteristics” without any further specification. France has elaborated
multi-criteria indexes for each plant species with weighting factors for each of the criteria and therefore already cater
for sustainability in a holistic manner. Most MS (e.g. Germany and The Netherlands) have simpler systems in place,
based on yield and pest resistance and include abiotic factors only for certain specific cases.
94
The targeted survey undertaken by ICF (2023) could only collect indicative data due to a low response rate. About
55% of forest nurseries assess basic material for sustainability characteristics and more than 55% out of those conduct
this assessment on a voluntary basis.
95
72% of basic material available in FOREMATIS is intended for the production of the lower quality FRM categories
(source-identified and selected material) whereby a minimal effort is undertaken to demonstrate the superiority of the
FRM in comparison with the efforts undertaken for the qualified and tested categories.
96
EUROSTAT (2020)
97
PESETA IV https://joint-research-centre.ec.europa.eu/peseta-projects/jrc-peseta-iv_en
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damaged wood (at EUR 201 per tonne of CO
2
) and additional indirect damages of EUR 6.5 billion
along various value chains
98
.
Third, the
scope of the FRM legislation is incomplete
as it is restricted to the production of FRM
for forestry purposes despite an increasing demand for FRM for non-forestry purposes under the
EGD
99
. Moreover, temporary difficulties in the supply of FRM are increasing because of a higher
incidence of adverse weather, drought and disasters caused by changing climatic conditions. This
results in the need for reforestation of damaged parts of the forests. Because of the restricted scope
of the legislation, the current FRM production levels are insufficient to address the higher demand
for FRM. In addition, MS have interpreted in a different way the activities
100
that are considered as
forestry purposes
101
causing a difference in scope between the national legislations. This problem
affects all operators active in the production and marketing of FRM because an activity that is
within the scope in one MS may be out of the scope of the legislation in another MS. Finally, the
legislation does not contain clear rules on the information to be provided to users of FRM by the
nurseries
102
, while such information is necessary for sound decision making in relation to tree
planting
103
. Without prior access to this information, users of FRM may plant trees that are not
suited for the regional climatic and ecological conditions in the worst-case scenario. This is likely
to result in forests that are more vulnerable to drought, pest attacks and other disturbances and
could in turn have a huge environmental, economic and social impact
104
.
2.2.
What are the problem drivers?
2.2.1.
Regulatory drivers
The long history of amendments of the legislation has led to a complex, incoherent and fragmented
legal framework that is not up to date with the current scientific and technical developments.
Certain provisions, as on OCs, are vague, therefore leaving significant margin for interpretation to
the MS and resulting in different conditions for operators. Furthermore, there are no legal means of
ensuring more coherent OCs and enforcement of the rules across MS
105
. The PRM and FRM
legislation has not been fully adjusted to the evolution of closely related policies (PHL, Organic
Regulation, OCR and SUR). Overlaps between the different policies create uncertainty about how
to implement the respective provisions, exacerbating the possibilities for different interpretations by
the MS and subsequently different conditions for operators.
98
99
Trenczec J.
et al.
(2022)
FRM production for non-forestry purposes makes up about 10% of FRM in most Member States (Section 3.8.6 to
Analytical summary report targeted survey by ICF (2023)).
100
Certain MS consider restoration of ecosystems and biodiversity conservation to be forestry purposes while others do
not.
101
Position paper submitted by EUFORGEN in reply to public consultation.
102
ICF (2021) Section 4.7.2.
103
Mauri
et al.
(2023)
104
Schuldt
et al.
(2020), Hlásny
et al.
(2021)
105
With the exception of fruit plants and FRM, the marketing Directives do not contain any provisions for audits of the
OC systems in MS.
19
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2.2.2.
New policy developments
At the time of its introduction, the PRM legislation focussed on productivity and good quality of
the PRM in order to ensure food security
106
, while the FRM legislation prioritised the origin of the
basic material and its characteristics suitable for forestry purposes. The legislation however has
limited means to address the new challenges in relation to sustainability, climate change adaptation
and biodiversity. This alignment is inadequate, as it does not provide the appropriate tools for
meeting the commitments made under EGD strategies. Rules for variety registration are not adapted
to the needs for less uniform varieties (such as the “organic varieties suitable for organic
production” under the Organic Regulation) and new locally adapted varieties. The comprehensive
scope of the current marketing rules restricts the activities related to conservation and sustainable
use of plant and forest genetic resources. The scope of the FRM legislation is unfit for the increased
demand for FRM due to climate change and the objectives of the Biodiversity Strategy. The
PRM/FRM legislation has also diverged from other related legislation (PHL, Organic Regulation,
OCR) that has significantly evolved over the last years.
2.2.3. New developments in science and technology
Developments in technology and new scientific knowledge lead to new processes of production of
PRM/FRM. New solutions are being developed with the use of BMTs and digital tools that have
the potential to simplify and render more efficient variety registration, certification of PRM and
FRM and marketing controls. The PRM and FRM legislation has not kept pace with these
advances, therefore leading to non-harmonised application of such techniques as MS increasingly
adopt national approaches (Annex 5, Section 8).
2.3.
How likely is the problem to persist?
In the absence of EU action, the differences between MS as regards the interpretation and
implementation of the existing marketing Directives will persist and are likely to further increase.
The lack of coherence of the PRM/FRM legislation with the PHL and OCR and resulting burdens
for NCAs and stakeholders will remain, such as the duplication of RNQPs in the marketing
Directives and the PHL and the uncertainty as regards the OCs on RNQPs. MS will likely continue
to deploy different solutions, further aggravating the differences of conditions for operators.
Technical innovations such as digital technologies and BMTs are more likely to be taken up by big
companies while there is a risk that SMEs would not invest in such technologies if there is no legal
certainty around the acceptance of their use (Annex 5, Section 8) thus impacting the
competitiveness of the EU industry in relation to other major international players (US, China) and
in lost opportunities in related innovation and marketing.
Disproportionate burdens for activities, such as seed conservation networks and breeding for
organic production and locally adapted varieties are likely to be aggravated. Without clarifying the
rules, such activities will depend on MS decisions to support them, leading to increased uncertainty
for the stakeholders concerned and a non-level playing field for operators. This situation is likely to
lead to further loss of cultivated diversity. Differences between MS related to sustainability
106
See for example the recitals of Directive Council Directive 66/402/EEC.
20
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characteristics in the examination of new varieties and the approach for registering “organic
varieties suitable for organic production” are also likely to further increase.
Activities, such as agroforestry, plantations for biomass production and the EU target of planting 3
billion additional trees by 2030 are gaining importance under the EGD. Those activities generate an
increasing demand in supply of FRM. Problems in supply of appropriate FRM are likely if the
scope of the FRM legislation is not adjusted accordingly.
Efforts to address the challenges around sustainability, climate change and biodiversity will be
undermined. In the medium or long term there could likely be insufficient incentives to produce
PRM and FRM that is adapted to new climatic conditions and could contribute to sustainable
production. More frequent extreme weather events (e.g. drought, heavy winds, and flooding) may
cause more regular difficulties in supply of PRM and FRM. This may in turn jeopardise the
availability of crops to ensure seed and food security as well as of tree seedlings for multifunctional
forestry purposes.
3.
W
HY SHOULD THE
EU
ACT
?
3.1.
Legal basis
The PRM legislative framework is based on Article 43(2) of the Treaty on the Functioning of the
European Union (TFEU) implementing the Common Agricultural Policy. The TFEU qualifies
agriculture as shared competence between the EU and its MS. All sectors of agricultural activity, as
well as ancillary activities upstream and downstream, have been largely regulated at EU level. This
means that in accordance with Article 2(2) TFEU, legislation in the area of agriculture is
predominantly a role for the institutions of the EU. The same legal basis should also be used for the
new act(s) that might be adopted as a result of this initiative.
3.2.
Subsidiarity: Necessity of EU action
The introduction of the EU Directives on the marketing of PRM/FRM has been a major contributor
to the creation of the internal market. The EU rules on marketing of PRM/FRM have had a
generally positive impact on free movement, availability and quality of PRM/FRM
107
. If there had
been no action at EU level, 27 systems instead of one would be in place today thus hindering the
movement within the internal market, distorting competition and increasing the financial burden
associated with registration of varieties and the necessary controls on the identity, health and
quality of PRM/FRM.
3.3.
Subsidiarity: Added value of EU action
Variety registration and certification and marketing of PRM and FRM rely on examinations,
assessments and inspections performed by NCAs. Their results are valid in all 27 MS and follow
the 'one key, several doors' principle. This ensures the quality of EU PRM and FRM while
safeguarding open and fair competition on the single market. However, the different interpretation
and implementation of the EU rules at national level has caused unequal conditions for operators
across MS. This requires a greater harmonisation of the legislation but at the same time MS need
107
FCEC(2008), ICF(2021).
21
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flexibility to adapt the production process and the examination of the characteristics of the plants to
local agro-ecological conditions and in the case of FRM to environmental and climatic conditions.
The unrestricted marketing of PRM and FRM throughout the EU territory is imperative to address
transboundary issues such as the climate and biodiversity crises, the need for sustainable production
to ensure food security and sustainable afforestation/reforestation to secure multi-functional forests
for future generations. The current geopolitical situation and energy crisis have elevated the
importance of securing agricultural and food production. Under the F2F, EU Adaptation and
Biodiversity Strategies several commitments were made that necessitate the amendment of the
PRM and FRM legislation. Those commitments mirror the demand from society for increased food
security, more sustainable food production, locally produced food, diversification of production
methods and multi-functional forests (e.g. timber production, biodiversity conservation, leisure
activities).
4.
O
BJECTIVES
: W
HAT IS TO BE ACHIEVED
?
4.1.
General objectives
The general objective of this initiative is to ensure, for all types of users, PRM and FRM of high
quality and diversity of choice, adapted to current and future projected climatic conditions that will
in turn contribute to food security, protection of biodiversity and restoration of forest ecosystems.
The availability and access to varieties and basic material with strengthened sustainability
characteristics are essential to improve sustainability by ensuring the stability of yield of
agricultural production and of the productivity of forest ecosystems.
To ensure a level playing field for operators across the EU;
To support innovation and competitiveness of the EU PRM/FRM industry;
To contribute to addressing sustainability, biodiversity and climate-related challenges.
4.2.
Specific objectives
To increase clarity and coherence of the legal framework through simplified, clarified and
harmonised basic rules on fundamental principles presented in a modern legal form;
To enable the uptake of new scientific and technical developments (in particular, innovative
production processes, BMTs and digital solutions);
To ensure availability of PRM/FRM suitable for future challenges;
To support the conservation and sustainable use of plant and forest genetic resources.
To harmonise the framework for OCs on PRM/FRM;
To improve coherence of PRM/FRM legislation with the PHL.
22
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4.3.
Intervention logic
Figure 2. Intervention logic
23
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5.
W
HAT ARE THE AVAILABLE POLICY OPTIONS
?
5.1.
What is the baseline from which options are assessed?
The baseline is a “no policy change” scenario, in which the current EU legislation on PRM and
FRM remains in force as it currently stands, while other policy initiatives (SUR and NGTs) will be
adopted. As regards PRM, the current VCU requirements provide a basic common framework for
the sustainability assessment of new varieties of agricultural plant species. For species not subject
to VCU assessment for variety registration (vegetables and fruit plants), the breeding of new
varieties depends only on the priorities set by the breeders and the degree to which they respond to
market demands. Increased yield, tolerance to pests and abiotic factors and other desirable
characteristics are in increasingly high demand by farmers, however present only to a certain extent
in the breeding efforts of new varieties
108
. As regards FRM, some elements of sustainability
assessment are in place only for the highest categories of FRM. Political priorities set by the EGD
Strategies (i.e. F2F, Biodiversity, Forest and Adaptation) and regulatory developments (e.g. the
initiative for a new regulation on the sustainable use of plant protection products, SUR) for reduced
use of fertilisers and pesticides also provide an incentive for breeders to develop new varieties that
are less dependent on such inputs and are, therefore, contributing to sustainability of agri-food
systems. The F2F, EU Forest Strategy
109
and SUR
110
recognise the necessity of introducing relevant
measures in the PRM/FRM legislation. Breeding of new varieties take on average over 10 years
depending on the species, while the timeframe for FRM can be much longer
111
. Over the same
timeframe, challenges as climate change are projected to have significant impacts on agriculture
and forestry
112
.
Efforts are made to compensate impacts of climate change by moving from south to north
agronomic practices (e.g. introduction or increase of irrigation in areas where it was previously not
necessary), varieties and species (e.g. cultivation of sorghum instead of maize to compensate for
reduced availability of water). However, these solutions are constrained by the new agro-ecological
conditions (e.g. precipitation rates, daylight, soil). In forestry there are longer cycles (several
decades) than in agriculture. It is therefore not likely that foresters will change the tree species used
in the mid-term period. Foresters could consider using the same tree species but from a different
provenance (origin). Moving of varieties and species from south to north is not a sufficient solution
in itself as there will not be enough area as soils are not always suitable for agricultural production
(e.g. tundra). Targeted breeding efforts for new varieties, new species and selection for FRM are
needed to overcome these constraints in order to be able to successfully move varieties and species
from south to north, but also for developing new varieties adapted to new conditions in the south.
The time frame assumed for the dynamic baseline is 10 years and assumes that other relevant EU
policies (SUR, NGTs and FSFS) would be implemented. Even if other initiatives would be
108
109
For example,
https://www.kws.com/corp/en/media-innovation/innovation/breeding-objectives/
F2F recognises that farmers need to have access to a range of quality seeds for plant varieties adapted to the
pressures of climate change. The EU Forest Strategy recognises that adapting forests to climate change and restoring
forests following climate damages will require large quantities of appropriate FRM.
110
SUR identifies new varieties with increased resistance to pests as one of the means to achieve its objectives.
111
Some tree species set seed only every decade. Trees can reach 100s of years depending on the species and as such
are likely to face unpredictable conditions over their lifetime.
112
Changes in temperature and precipitation as well as weather and climate extremes are already influencing crop
yields and forest productivity in Europe. The number of extreme events negatively affecting agriculture in Europe is
projected to increase. Other climate change effects are increase in plant pests, changing patterns in water availability for
irrigation, changes in species range and forest composition. EEA (2016) and EEA (2019).
24
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successful in halting/limiting greenhouse gas emissions, the impacts of climate change would
persist. Adaptation of new varieties and species and of FRM to those impacts would still be needed.
In absence of regulatory changes for steering the breeding of new varieties for characteristics
necessary to face those challenges, new varieties and FRM would gradually become unsuitable for
the current and future challenges. A recent assessment suggests that current breeding programmes
and variety selection practices do not sufficiently prepare for climatic uncertainty and variability
113
.
The opportunity to mitigate the impacts of climate change that are already occurring would be lost
(e.g. on average EUR 4.8 billion/year of crop losses caused by drought in the EU, 4.9% of canopy
cover loss in Germany in 2018-2020
114
). Similarly, opportunities would be missed to introduce
varieties with improved disease resistance that could help reduce the use of pesticides.
The problems resulting from the limitation of activities that can be carried out under official
supervision, incoherence and/or duplications between PRM/FRM legislation and PHL, OCR and
the Organic Regulation, the use of innovative production processes, BMTs, and digital solutions
will remain. They are expected to persist and gradually aggravate, as MS will continue to adopt
divergent national practices.
Under the baseline there are no provisions in the EU legislation for the use of innovative production
processes, BMTs and digital solutions. For this reason, an effort to resolve these issues by EU
guidelines would be impossible without any revision of the EU legislation. The absence of a
common EU framework will lead to further divergence of conditions for operators across the
Union. In turn, the burdens for NCAs and operators are expected to increase, leading to reduced
competitiveness of the EU PRM and FRM sectors. Likewise, the clarification and streamlining of
existing administrative procedures cannot be resolved without changing the legislation. That
clarification in most cases concerns the streamlining and/or simplification of procedures across crop
groups such as the decision-making procedure for regulation/deregulation of species. In Directive
2008/90/EC on fruit plants, the decision to regulate/deregulate species is based on the Comitology
procedure while in the Directives on agricultural species the co-decision procedure applies
115
.
Experience gained by temporary experiments has shown that certain aspects of the legislation can
be simplified. For example, the extension of the possibility for operators to carry out certification
activities for pre-basic and basic seed of agricultural species has been shown to be equally reliable
as official certification but with reduced costs for the operators. However, permanent
implementation of such changes is not possible under the baseline without a revision of the
legislation. The legislative framework will furthermore remain cumbersome for activities linked to
the conservation and sustainable use of plant and forest genetic resources. Currently the Common
Catalogues contain a small number of conservation varieties
116
and no forest genetic resources
117
.
The number of conservation varieties of agricultural plant species and vegetable species added to
the Common Catalogues every year is negligible. There is no indication that this trend will change
over the next years under the baseline.
113
114
Kahiluoto
et al.
(2019)
Thonfeld
et al.
(2022) In the period 2018-2020 4.9% of canopy cover was lost in German forests because of extreme
drought and tree species unsuitable for the environmental and climatic conditions.
115
The list of species can be amended by comitology but at the same time the technical requirements for the new
species must be introduced in the basic act by co-decision.
116
Conservation varieties constitute less than 1% of the varieties of agricultural and vegetable species.
117
The FRM Common Catalogue (https://ec.europa.eu/forematis) does not contain any forest genetic resources due to
the cumbersome process for the registration of basic material fit for use as forest genetic resources.
25
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Breeding of varieties for organic production and low-input agriculture and of varieties adapted to
local agro-ecological conditions will remain under the baseline marginal activities because such
varieties are often too heterogeneous to meet the uniformity requirements under DUS examination,
while they are not covered by the current derogations for conservation varieties. Provisions on
organic heterogeneous material recently introduced by the Organic Regulation offer a partial
solution as the production of this type of material is restricted to certified organic production
(Annex 5, Section 2.5).
5.2.
Description of the policy options
The options were designed based on the PRM study, the supporting studies and by reassessing
elements of the 2013 impact assessment. The options constitute the best options to address the
problems, albeit to a different extent. Alternative measures have been reviewed but discarded at an
early stage due to lack of stakeholder support (Section 5.3). There was no reason to design options
that deregulate the sector as no stakeholder supported it.
The options share a common set of measures which are the same for all options (Figure 3). Some of
those common measures are only for PRM and others are only for FRM. There is overall support in
the PRM/FRM sector for maintaining the current regulatory system and its two basic pillars of
registration of varieties/basic material and PRM/FRM certification. The policy options have
therefore been designed from a spectrum of highest flexibility for MS and operators (option 1) to
one of highest harmonisation with little to no room for individual flexibility (option 3) with option
2 presenting a balanced approach. The current presentation of the 3 options graded as described in
terms of flexibility/harmonisation seemed to be the most coherent approach, especially given the
number of issues to be addressed and taking into account their actual feasibility in relation to the
interaction with various stakeholders. The design of the policy options considered the priority of the
F2F to address sustainability challenges. Hence, under all options the sustainability requirements
for the approval of new varieties are strengthened.
The flexibility which the MS need relates in the first place to their national agro-ecological
conditions. The MS will continue to be exempted from the scope of the legislation for certain crops
(e.g. vine not growing in Nordic MS). Variety testing including relevant variety characteristics
needs to be adapted to the climatic conditions (e.g. cold tolerance in the North and drought
tolerance in the South) or the certification requirement to combat noxious weeds (Avena
fatua
in
certain MS).
Under all options, a transitional period will be foreseen to allow the reorientation of breeding
efforts towards varieties with improved sustainability characteristics. The defining elements of the
options for both PRM and FRM are:
Strengthened sustainability requirements;
Conservation and sustainable use of plant and forest genetic resources;
Official controls;
Enable uptake of BMTs, innovative production processes and digital solutions.
26
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2733822_0028.png
Figure 3. Design of options
27
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2733822_0029.png
5.2.1.
Measures common to all options
Apart from the no policy change scenario all 3 options share
a core of several common measures
aimed at simplifying administrative procedures and a more flexible decision-making process, as
this is a problem which affects the efficiency of processes.
For PRM and FRM legislation:
All professional operators to be registered in a single register under the PHL
118
.
All certification tasks are permitted under
official supervision
except the issuing of the
official label (PRM) and the Master certificate (FRM).
To avoid overlaps with PHL, PRM/FRM legislation will directly refer to PHL for the list of
RNPQs and specific measures. Compliance with requirements for QPs and RNQPs will
remain a prerequisite for the certification of PRM/FRM.
For PRM legislation:
Simplification of existing administrative procedures:
-
Decisions for addition of new species in, or removal of species from, the scope of the
PRM legislation and Decisions on the equivalence to EU rules for third countries will be
taken by means of tertiary legislation
119
.
-
The transfer/notification of new varieties from national to the EU Plant Variety Portal
will be managed by the MS without the need for a Commission Decision
120
.
-
Allow MS to decide themselves on permitting temporarily the marketing of seed that
does not satisfy the requirements in respect of minimum germination, if germination is
not lower than 15 % than the required germination rate
121
.
The requirements for the registration of
organic varieties suitable for organic production
(Annex 5, Section 2.5) will be adapted to the specific needs of organic production, by
providing the possibility to deviate from certain DUS requirements as regards uniformity.
The rules for
conservation varieties
are lighter and extended to cover
new locally adapted
varieties
(Annex 5, Section 2.6.).
118
Currently professional operators in the sectors of fruit plants and FRM are obliged to be registered both under the
marketing Directives and the PHL.
119
Currently this is already the case for some marketing Directives for both the addition of new species and
equivalence. However, some Directives require that for such decisions the ordinary legislative procedure is followed,
which is cumbersome and disproportionate compared to the technical nature of the matter.
120
On the basis of notifications received from MS, the Commission publishes in the Official Journal of the European
Communities under the titles ‘Common Catalogue of Varieties of Agricultural Plant Species’ and ‘Common Catalogue
of Varieties of Vegetables Species’ lists of all the varieties of which the seed and propagating material can be marketed
throughout the EU. The publication of the supplements to the Common Catalogues requires a Commission Decision.
This procedure creates unnecessary waiting time until a variety is included in the Common Catalogues and gets access
to the common market.
121
Currently MS wishing to use this derogation have to inform the Commission and the other MS who can make an
offer to cover the missing supply. If no offers are received, the MS are authorised to allow the marketing of seed with
lower germination rate by a Commission Decision. The procedure is disproportionate as most often there are no
suitable offers. Over the last five years only 5 to 12% of the requested amounts could be covered by seed offered by
other MS. Around 85% of the requests concern germination 15% or less below the minimum germination as laid down
in the seed marketing Directives.
28
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The scope for heterogeneous material is broadened beyond organic production (Annex 5,
Section 2.5.).
For FRM legislation:
The decisions on the equivalence to EU rules for third countries will be taken by means of
tertiary legislation.
The existing empowerment to define the
information to be made available to
users/buyers of FRM
is extended to explicitly cover suitability of FRM for climatic and
ecological conditions.
5.2.2. Option 1 - Highest flexibility
Option 1 gives the highest level of flexibility to MS in relation to enabling the uptake of innovative
production processes, BMTs and digital solutions, the sustainability considerations in the
assessment of new varieties/FRM, OCs and the activities of seed conservation networks, marketing
to amateur gardeners and exchange in kind of PRM between farmers.
Common elements for PRM and FRM:
The uptake of
innovative production processes, BMTs and digital solutions
will be
enabled by introducing in the PRM/FRM legal framework provisions allowing their use.
Under option 1, these new possibilities will be implemented by the adoption of guidelines
based on existing international standards but adjusted to the specificities of the EU
legislation (Annex 5, Section 8).
-
The use of BMTs will be clarified by allowing the use in variety registration process to
speed up DUS testing and as a supplementary test in PRM/FRM certification and
marketing controls, in those cases where the field inspection and control plot testing are
inconclusive about the identity of the variety under investigation.
-
The PRM/FRM legal framework will allow the certification of PRM/FRM produced by
innovative production processes such as
in vitro
propagation of clones, true potato seeds
and seed for the production of PRM of fruit plants and vines.
-
The PRM/FRM legal framework will allow the use of digital technologies (e.g. digital
certificates and digital labels) and digitalisation of the PRM/FRM certification system.
Option 1 lays down minimum requirements for PRM/FRM OCs. Risk based OCs aligned
with the OCR provisions will be introduced and MS will be required to prepare a multi-
annual control plan, aligned with the principles of the OCR. However, all rules on OCs
remain in the PRM/FRM legislation. More specifically, requirements for OCs on
production, marketing and imports of PRM/FRM are introduced in the PRM/FRM
legislation (e.g. delegation of OC tasks and multi-annual national control plans) but without
linking these to the OCR.
For PRM legislation only:
Sustainability considerations
in the examination of new varieties are strengthened.
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2733822_0031.png
-
The current VCU examination for agricultural plant species and vine is extended to
include characteristics that contribute to sustainable production in order to better steer
breeding efforts in this direction. The new examination will be called ‘Value for
sustainable cultivation and use’ (‘VSCU’). For organic varieties suitable for organic
production, it will be required that the VSCU examination is carried out under
conditions adapted to the specific needs of organic production.
-
A new voluntary approach is adopted for the assessment of new varieties of other crop
groups (i.e. fruit plants and vegetables) for characteristics that contribute to sustainable
production. Applicants may submit along with their application for the registration of a
new variety the results of trials that they have carried out themselves. A link to this
information is published in the Common Catalogues
122
. Submission of any information
is not linked to the acceptance of the varieties.
The activities of
seed conservation networks, marketing to amateur gardeners and
exchange in kind of seed between farmers
are exempted from the scope of the legislation
to stimulate the increase in genetic diversity of PRM.
For FRM legislation only:
“Forestry”/“non-forestry” purposes are defined but the
scope of the legislation
remains
limited to the production of FRM for “forestry” purposes. The FRM legislation only covers
the production for “forestry purposes” to ensure the availability of high-quality FRM for
afforestation/reforestation.
The
sustainability requirements
are extended to cover lower FRM categories (source-
identified and selected material) and guidelines are adopted on sustainability requirements
for all FRM categories.
Empowerment to authorise MS to use FRM not fulfilling all requirements when there are
temporary
difficulties in supply
is maintained and supplemented by adoption of guidelines
on
contingency planning
in the MS to better prepare for major shortages in supply of FRM
caused by extreme weather, disasters or any other event.
Adoption of guidelines for the registration of basic material for the purposes of
conservation and sustainable use of forest genetic resources.
5.2.3.
Option 2 - Balancing flexibility and harmonisation
Option 2 balances the need for flexibility with a higher degree of harmonisation to overcome the
problems stemming from differences in interpretation.
Common elements for PRM and FRM:
The uptake of
innovative production processes, BMTs and digital solutions
will be
enabled by introducing in the PRM/FRM legal framework provisions allowing their use.
Under option 2, these new possibilities will be implemented by the introduction of basic
122
As of beginning of 2023 the Common Catalogues are accessible through a new EU Plant Variety Portal. This will
allow in the future to include links to MS’s sites where variety descriptions are published.
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principles for the use of
innovative production processes, BMTs and digital solutions
in
the legislation (Annex 5, Section 8).
-
The use of BMTs will be clarified by allowing the use in variety registration process to
speed up DUS testing and as a supplementary test in PRM/FRM certification and
marketing controls, in those cases where the field inspection and control plot testing are
inconclusive about the identity of the variety under investigation.
-
The PRM/FRM legal framework will allow the certification of PRM/FRM produced by
innovative production processes such as
in vitro
propagation of clones, true potato seeds
and seed for the production of PRM of fruit plants and vines.
-
The PRM/FRM legal framework will contain rules on the use of digital technologies
(e.g. digital certificates and digital labels) and foresee the possibility for digitalisation of
the PRM/FRM certification system.
Risk based OCs aligned with the OCR provisions will be introduced and MS will be
required to prepare a multi-annual control plan. The OCs for PRM/FRM will be brought
under the scope of the OCR, but with simplified import controls at appropriate places within
the EU to ensure a more targeted and efficient enforcement of existing rules
123
. Specific
rules for production, marketing and imports will be established through tertiary legislation
under the OCR. OCR will apply to all OCs in the sector. Article 44(1) to Regulation (EU)
2017/625 will apply for PRM/FRM import controls, which will be performed at appropriate
places within the EU
124
. The operator responsible for the PRM/FRM consignment must
provide the relevant information about that consignment (e.g. quantity of PRM/FRM, type
of material, category of material,…). OCs in relation to PRM/FRM certification remain in
the sectoral PRM/FRM legislation.
For PRM legislation only:
Sustainability considerations
in the examination of new varieties are strengthened.
The current VCU examination for agricultural plant species and vine is extended to include
additional characteristics that contribute to sustainable production in order to better steer
breeding efforts in this direction. The new examination will be called Value for sustainable
cultivation and use (VSCU). It will also be extended to new varieties of the other crop
groups (fruit plants and vegetables).
-
MS will have the flexibility to implement VSCU according to their agro-ecological
conditions.
-
It will be possible for operators to conduct the VSCU examination under official
supervision.
-
MS will be able to collaborate and accept results from MS with similar agro-ecological
conditions, and/or create shared testing networks.
123
This approach is in line with Article 44(1) to Regulation (EU) 2017/625 for OCs on animals and goods other than
those subject to OCs at border control posts.
124
OJ L 95, 7.4.2017, p. 1
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-
An empowerment will be created to determine the minimum requirements for carrying
out the VSCU examination and the accepted methodologies for assessing the individual
VSCU characteristics.
-
For organic varieties suitable for organic production, it will be required that the VSCU
examination is carried out under conditions adapted to the specific needs of organic
production.
The activities of
seed conservation networks, marketing to amateur gardeners and
exchange in kind of seed between farmers
are subject to lighter rules to stimulate the
increase in genetic diversity of PRM but also retain traceability and guarantee a minimum
level of PRM quality.
For FRM legislation only:
The “forestry” and “non-forestry” purposes are defined and the current
scope of legislation
is extended to increase the FRM quality beyond afforestation/reforestation uses and include
the production of FRM for specific “non-forestry” purposes.
The
sustainability requirements
are extended to cover lower FRM categories (source-
identified and selected material). General principles on the sustainability requirements are
introduced in the legislation for all FRM categories, with flexibility for MS to implement
according to their environmental conditions.
The existing empowerment to authorise MS to use FRM not fulfilling all requirements when
there are temporary
difficulties in supply
is supplemented by the introduction in the
legislation of a general requirement for
contingency planning
by the MS to better prepare
for major shortages in the supply of FRM caused by extreme weather, disasters or any other
event.
A derogation is introduced in the legislation for the registration of basic material for the
purposes of
conservation and sustainable use of forest genetic resources.
5.2.4.
Option 3 - Highest harmonisation
Option 3 would entail the highest harmonisation in order to minimise differences in the
implementation of the legislation.
Common elements for PRM and FRM:
The uptake of
innovative production processes, BMTs and digital solutions
will be
enabled by introducing in the PRM/FRM legal framework provisions allowing their use.
Under option 3, these new possibilities will be implemented by the introduction of detailed
and binding rules for the use of
innovative production processes, BMTs and digital
solutions
in the legislation (Annex 5, Section 8).
-
The use of BMTs will be clarified by allowing the use in variety registration process to
speed up DUS testing and as a supplementary test in PRM/FRM certification and
marketing controls, in those cases where the field inspection and control plot testing are
inconclusive about the identity of the variety under investigation.
-
The PRM/FRM legal framework will allow the certification of PRM/FRM produced by
innovative production processes such as
in vitro
propagation of clones, true potato seeds
and seed for the production of PRM of fruit plants and vines.
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-
The PRM/FRM legal framework will contain detailed rules on the use of digital
technologies (e.g. digital certificates and digital labels) and the conditions for
digitalisation of the PRM/FRM certification system.
Risk based OCs aligned with the OCR provisions will be introduced and MS will be
required to prepare a multi-annual control plan. The OCs for PRM/FRM will be brought
under the scope of the OCR, with stricter import controls at border control posts requiring
special import documentation pursuant to Article 47(1) to Regulation (EU) 2017/625
125
to
strengthen and fully harmonise enforcement. Specific rules for production, marketing and
imports will be established through tertiary legislation under the OCR. OCR will apply to
all OCs in the sector. For each consignment of PRM/FRM subject to OCs at border control
posts, the operator responsible for the consignment must complete the relevant part of the
Common Health Entry Document (CHED), providing the information necessary for the
immediate and complete identification of the consignment and its destination. Rules on fees
will be laid down by MS pursuant to Article 79 of the OCR.
For PRM legislation only:
Sustainability considerations
in the examination of new varieties are strengthened.
The current VCU examination for agricultural plant species and vine is extended to include
additional characteristics that contribute to sustainable production in order to better steer
breeding efforts in this direction. The new examination will be called Value for sustainable
cultivation and use (VSCU). It will also apply to new varieties of the other crop groups
(fruit plants and vegetables).
In contrast to option 2:
-
Implementation of the VSCU will be harmonised between the MS.
-
Detailed rules on accepted methodologies for assessing the individual VSCU
characteristics will be introduced and harmonised across MS. The VSCU examination
would still be conducted in different locations that reflect the different agro-ecological
conditions in each MS. However, this could result in a MS having to test for
tolerance/resistance to plant pests that do not occur in their territory. This on the one
hand would lead to the highest assurance regarding the variety characteristics but would
on the other hand also lead to unnecessary costs.
As under option 2:
-
It will be possible for operators to conduct the VSCU examination under official
supervision.
-
MS will be able to collaborate and accept results from MS with similar agro-ecological
conditions, and/or create shared testing networks.
125
OJ L 95, 7.4.2017, p. 1
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-
For organic varieties suitable for organic production, it will be required that the VSCU
examination is carried out under conditions adapted to the specific needs of organic
production.
The activities of
seed conservation networks, marketing to amateur gardeners and
exchange in kind of seed between farmers
are subject to the general requirements of the
legislation (See Annex 5, Sections 2.3. and 2.4.) to achieve homogenous rules for all market
segments.
For FRM legislation only:
The “forestry” and “non-forestry” purposes are defined and the current
scope of legislation
is extended to increase the FRM quality beyond afforestation/reforestation uses and include
the production of FRM for specific “non-forestry” purposes.
The
sustainability requirements
are extended to cover lower FRM categories (source-
identified and selected material). Detailed and harmonised rules on sustainability
requirements for all FRM categories are introduced in the legislation.
The existing empowerment to authorise MS to use FRM not fulfilling all requirements when
there are temporary
difficulties in supply
is supplemented by the introduction in the
legislation of common rules for
contingency planning
by the MS to better prepare for
major shortages in supply of FRM caused by extreme weather, disasters or any other event.
A derogation is introduced in the legislation for the registration of basic material for the
purposes of
conservation and sustainable use of forest genetic resources.
Option 1
A number of existing
administrative procedures are
clarified and simplified
Permit under official supervision
all certification tasks except the
issuing of the official label
(PRM) and the issuing of the
master certificate (FRM)
Option 2
A number of existing
administrative procedures are
clarified and simplified
Permit under official supervision
all certification tasks except the
issuing of the official label
(PRM) and the issuing of the
master certificate (FRM)
Option 3
A number of existing
administrative procedures are
clarified and simplified
Permit under official supervision
all certification tasks except the
issuing of the official label
(PRM) and the issuing of the
master certificate (FRM)
Policy issue
addressed
Simplification of
procedures
[measures common to all options]
Innovative
production
processes, BMTs
and digitalisation
The uptake on the use of
innovative production processes,
BMTs and digital solutions will
be enabled by introducing in the
PRM/FRM legal framework
provisions allowing their use.
Adoption of guidelines on
innovative production processes,
BMTs and digitalisation
[measures common to all options]
The uptake on the use of
innovative production processes,
BMTs and digital solutions will
be enabled by introducing in the
PRM/FRM legal framework
provisions allowing their use.
Introduction of basic rules on
innovative production processes,
BMTs and digitalisation and
creation of empowerments for
detailing rules according to new
developments
Harmonisation of OCs on
production, marketing and
imports of PRM/FRM subject to
the OCR
Simplified import controls at
appropriate places
[measures common to all options]
The uptake on the use of
innovative production processes,
BMTs and digital solutions will
be enabled by introducing in the
PRM/FRM legal framework
provisions allowing their use.
Introduction of detailed rules on
innovative production processes,
BMTs and digitalisation
Official controls
Harmonisation of OCs on
production, marketing and
imports of PRM/FRM without
links to OCR
Harmonisation of OCs on
production, marketing and
imports of PRM/FRM subject to
the OCR
Stricter import controls at border
control posts requiring special
import documentation
34
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2733822_0036.png
Policy issue
addressed
Option 1
The lists of RNQPs and specific
measures are moved to the PHL
and PRM/FRM legislation refer
to them instead of duplicating
them
Compliance with requirements
for QPs and RNQPs remains a
prerequisite for the certification
of PRM/FRM through the
continuation of the current robust
certification regime
Option 2
The lists of RNQPs and specific
measures are moved to the PHL
and PRM/FRM legislation refer
to them instead of duplicating
them
Compliance with requirements
for QPs and RNQPs remains a
prerequisite for the certification
of PRM/FRM through the
continuation of the current robust
certification regime
Option 3
The lists of RNQPs and specific
measures are moved to the PHL
and PRM/FRM legislation refer
to them instead of duplicating
them
Compliance with requirements
for QPs and RNQPs remains a
prerequisite for the certification
of PRM/FRM through the
continuation of the current robust
certification regime
Plant health
requirements
[measures common to all options]
Extension of the current VCU
requirements for agricultural
plant species and vine to better
address sustainability
For all other species, reliance on
information that applicants
voluntarily submit along with the
application for registration of a
new variety
[measures common to all options]
Extension of the current VCU
requirements for agricultural
plant species and vine to better
address sustainability
Introduction of these
requirements for all other crop
groups (vegetables and fruit
plants)
Flexibility for MS to implement
these requirements according to
their agro-ecological conditions
Permit examination of these
requirements under official
supervision
Creation of empowerment to
adopt rules on accepted
methodologies for assessing the
different characteristics
For the examination of organic
varieties DUS and VCU
requirements are adapted to the
specific needs of organic
production
[measure common to all options]
Subject activities of seed
conservation networks, marketing
to amateur gardeners and
exchange in kind of seed between
farmers to lighter rules
Simplification of current rules for
conservation varieties and
extension of those rules to cover
new locally adapted varieties
Broadened scope for
heterogeneous material beyond
organic production
[measure common to all options]
Define forestry and non-forestry
purposes and extend scope of
FRM legislation to include the
production of FRM for specific
non-forestry purposes
Extend sustainability
requirements to cover lower FRM
[measures common to all options]
Extension of the current VCU
requirements for agricultural
plant species and vine to better
address sustainability
Introduction of these
requirements for all other crop
groups (vegetables and fruit
plants)
Harmonised implementation of
these requirements.
Permit examination of these
requirements under official
supervision
Introduction of detailed rules on
accepted
methodologies
for
assessing
the
different
characteristics
For the examination of organic
varieties DUS and VCU
requirements are adapted to the
specific needs of organic
production
[measure common to all options]
Subject activities of seed
conservation networks, marketing
to amateur gardeners and
exchange in kind of seed between
farmers to the general
requirements of the legislation
Simplification of current rules for
conservation varieties extension
of those rules to cover coverage
by the same rules of new locally
adapted varieties
Broadened scope for
heterogeneous material beyond
organic production
[measure common to all options]
Assessment of new
varieties for
characteristics
contributing to
sustainable
production
Organic
production
For the examination of organic
varieties DUS and VCU
requirements are adapted to the
specific needs of organic
production
[measure common to all options]
Conservation and
sustainable use of
plant genetic
resources
Exemption from the scope of the
legislation of activities of seed
conservation networks, marketing
to amateur gardeners and
exchange in kind of seed between
farmers
Simplification of current rules for
conservation varieties and
extension of those rules to cover
new locally adapted varieties
Broadened scope for
heterogeneous material beyond
organic production
[measure common to all options]
Scope of the FRM
legislation
Assessment of
Define forestry and non-forestry
purposes but maintain current
scope of FRM legislation
Define forestry and non-forestry
purposes and extend scope of
FRM legislation to include the
production of FRM for specific
non-forestry purposes
Extend sustainability
requirements to cover lower FRM
Extend sustainability
requirements to cover lower FRM
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2733822_0037.png
Policy issue
addressed
FRM for
characteristics
contributing to
sustainable
production
Option 1
categories
Adopt guidelines on
sustainability requirements for all
FRM categories
Option 2
categories
Introduce general principles on
sustainability requirements for all
FRM categories with flexibility
for MS to implement according to
their environmental conditions
Maintain the existing
empowerment to authorise MS to
use FRM not fulfilling all
requirements when there are
difficulties in supply
Introduce a general requirement
for contingency planning in the
MS to ensure availability of FRM
Extend existing empowerment to
define the information to be made
available to users/buyers of FRM
to explicitly cover suitability of
FRM for climatic and ecological
conditions
[measure common to all options]
Introduction of a derogation for
the registration of basic material
for the purposes of conservation
of forest genetic resources
Option 3
categories
Introduce detailed and
harmonised rules on
sustainability requirements for all
FRM categories
Maintain
the
existing
empowerment to authorise MS to
use FRM not fulfilling all
requirements when there are
difficulties in supply
Introduce common rules on
contingency planning in the MS
to ensure availability of FRM
Extend existing empowerment to
define the information to be made
available to users/buyers of FRM
to explicitly cover suitability of
FRM for climatic and ecological
conditions
[measure common to all options]
Introduction of a derogation for
the registration of basic material
for the purposes of conservation
of forest genetic resources
Address difficulties
in supply of
suitable FRM
Maintain the existing
empowerment to authorise MS to
use FRM not fulfilling all
requirements when there are
difficulties in supply
Adopt guidelines on contingency
planning to ensure availability of
FRM
Extend existing empowerment to
define the information to be made
available to users/buyers of FRM
to explicitly cover suitability of
FRM for climatic and ecological
conditions
[measure common to all options]
Information to
FRM users/buyers
Conservation and
sustainable use of
forest genetic
resources
Adoption of guidelines for the
registration of basic material for
the purposes of conservation of
forest genetic resources
Table 2. Overview of policy options
5.2.5.
Stakeholders’ views on policy options
Stakeholder consultations showed that there is overall support in the PRM sector for maintaining
the current regulatory system and its two basic pillars of variety registration (based on DUS and
where applicable VCU) and PRM certification. NCAs and stakeholders, in particular the seed
industry, highlighted that the current system works well and that the EU PRM industry receives
international recognition for the high quality of the certified seed. Likewise, in the FRM sector
there is overall support for keeping the existing regulatory system of registration of basic material
and FRM certification. The majority of NCAs, a business association and an EU trade union called
for maintaining the current alignment of the EU FRM legislation with the Rules and Regulations of
the OECD Forest Seed and Planting Scheme. All NCAs and stakeholders emphasised that the FRM
legislation should remain separate from the PRM legislation. They argued that as forest trees often
have a life span of over 100 years, some rules that apply to PRM might neither be needed for FRM,
nor be reasonable to implement due to the difficulty of ensuring consistency over such long periods
of time.
As regards PRM, the majority of NCAs and stakeholders is in favour of option 2 with the exception
of the extension of the assessment of sustainability characteristics to all crop groups including fruit
plants and vegetables. A few NCAs and stakeholders express a preference for option 3. A number
of stakeholder groups is in favour of option 1 as regards e.g. the exemption from the scope of
certain activities. As regards FRM, most NCAs and regional forest authorities, a regional union of
forest nurseries and an NGO emphasised that MS should have the flexibility to decide which FRM
is best adapted to their regional climatic and ecological conditions. For this reason, several
stakeholders expressed preference for maintaining a Directive (option 1). Some business
associations and a trade union expressed preference for a full harmonisation of the legislation.
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NCAs and stakeholders strongly agree with the set of common measures proposed (Section 5.2.1.),
with the exception of permitting certification tasks to be carried out by operators under official
supervision instead of being carried out directly by the NCAs. Certain stakeholders are concerned
that this will be disadvantageous for SMEs that do not have sufficient resources to carry out
certification tasks under official supervision. The new legislation will however oblige MS to
maintain official certification in order to respond to the needs of SMEs. No other alternative
solutions that would allow simplification of administrative procedures have been identified.
One main objective of the revision is to extend the assessment of characteristics contributing to
sustainable agri-food production. With the exception respondents from business associations, a
majority of NCAs and stakeholders agreed with the need for a set of general sustainability criteria
that MS can apply taking into account their agro-ecological conditions. Several stakeholders
highlighted the difficulties of harmonising VCU across MS (option 3), the need for, and
implications of, new sustainability criteria as well as suggested approaches for sustainability
criteria.
The seed sector’s position as regards agricultural plant species is that the sustainability assessment
of new varieties can be addressed with slight modifications of the current VCU, while available
information should be used before new obligations and costs are introduced for species other than
agricultural plant species. The sector argues that such information is already available as other
legislation and targets (organic production, reduction of pesticides and fertilisers), climate change
conditions and market demand have been steering breeding towards the examination of more
sustainable characteristics.
Some stakeholders call to abolish the current VCU requirement (and not to introduce a
sustainability assessment) for:
seed potatoes, using arguments similar to the vegetable sector mentioned above;
crops for which there are very few applications for registering new varieties and where the
current VCU makes it even more difficult for those varieties to reach the market. Moreover,
they state that NCAs are not in a position to organise the relevant examinations every year.
The organic sector calls for a specific VCU examination adapted to organic varieties suitable for
organic production. Moreover, they are of the opinion that all new plant varieties should be
examined under organic and/or low input conditions. This opinion is shared by some seed saver
organisations.
Several NGOs and small farmers’ organisations overall reject the principle of VCU assessment of
new varieties. In their view, this examination guarantees the adaptation of new varieties to certain
local and regional agro-ecological conditions but not the adaptability of the varieties to different
agro-ecological conditions. In their view, the adaptability of varieties is key for the resilience of
agriculture to climate change. This approach is dealt with in the options by establishing the
conditions for heterogeneous material, organic varieties suitable for organic conditions and the
exchange in kind of seed between farmers.
Stakeholders’ views differ regarding the measures proposed under the options to facilitate the
conservation and sustainable use of plant genetic resources. NCAs and most stakeholders agree
with the common measure under all options to adapt the DUS and VCU requirements for the
examination of organic varieties to the specific needs of organic production. The seed sector on the
37
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contrary states that organic varieties should comply with the current DUS requirements. NCAs and
stakeholders agree with lighter rules for conservation varieties and new locally adapted varieties,
but the seed sector would like to maintain the current restriction related to the local marketing of
those varieties in their region of origin. Stakeholders’ views are mixed as regards the activities of
seed conservation networks and exchange in kind of seed between farmers. NGOs and certain
academia favour an exemption of these activities from the scope of the legislation. They refer to
UNDROP and the rights of peasants to freely exchange, multiply and sell seed In relation to
exchange in kind of seed, the seed sector is concerned that a total exemption could be misused by
farmers and calls for a quantitative restriction. As regards the activities of seed conservation
networks, the seed sector is of the opinion that PRM marketed for the purposes of conserving plant
genetic resources should be subject to the same rules as organic heterogeneous material. All NCAs
and stakeholders agree with the broadening of the scope of heterogeneous material beyond organic
production.
The majority of NCAs and stakeholders fear an increase in administrative burden upon the
inclusion of OCs into the scope of the OCR (options 2 and 3). Several NCAs and businesses
recognise the divergent conditions for operators and marketed PRM and FRM across MS. They
prefer for OCs to be included into the scope of the OCR, albeit with simplified import controls
(option 2). They see the advantages of using common IT applications for OCs such as IMSOC.
Only a few stakeholders are in favour of a full inclusion into the scope of the OCR with stricter
import controls at border control posts (option 3).
Most NCAs and stakeholders including SMEs want to have the possibility of using BMTs and
digital solutions. Some SMEs highlight a lack of resources for being able to invest in BMTs and
digitalisation. As regards the use of BMTs some stakeholders agree if their use remains optional in
addition to the observation of the phenotypic characteristics. Others ask for the use of BMTs as
self-standing tools for the characterisation of new plant varieties. Most NCAs call for allowing the
use of innovative production processes such as the production of hybrid seed in the fruit plant
sector and the use of
in vitro
propagation methods including somatic embryogenesis to produce
PRM and FRM.
As regards FRM, stakeholders’ views were mixed regarding the extension of the scope of the
legislation to include certain specific non-forestry purposes. About 50% of stakeholders from
across stakeholder categories believed that the definition of FRM should be clarified in relation to
the purposes for which it is produced. Most stakeholders felt that FRM production should cover
wood production, afforestation, reforestation, and conservation and sustainable use of forest genetic
resources. In contrast, 52% believed that tree planting in urban and peri-urban areas and plantations
for protection purposes (shelter belts against the wind) should not be covered.
Most stakeholders were favourable towards the assessment of sustainability characteristics with
over half of the operators stating that they already assess, either on a voluntary or mandatory basis,
basic material and FRM for characteristics that contribute to sustainable afforestation and
reforestation. In relation to difficulties in supply, about half of stakeholders from across stakeholder
groups recognise the need for more long-term planning across the FRM supply chain. They
identified potential risks in the form of using lower quality FRM, economic losses and the
increasing need of import. They expect that the demand for FRM will likely increase in the next 20
years further underlying the importance of security of supply and climatic suitability of FRM. This
justifies the proposed measures on national contingency plans and better informing FRM
users/buyers about the FRM characteristics.
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Stakeholders active in the conservation and sustainable use of forest genetic resources declared that
the current FRM legislation cannot address the needs of this type of FRM. They agree with the
introduction of a derogation from the requirements for the registration of basic material (option 2).
5.3.
Options discarded at an early stage and alternative measures
No full policy options were discarded at an early stage. Some specific measures however have been
considered and discarded as unfeasible. Total deregulation is not supported by any stakeholder. To
a lesser or greater extent all agree that the current system is functional and relevant. Abolishing the
legislation would lead to different regulatory approaches at MS level with the possibility to threaten
the principle of the internal market and leading to a lack of transparency of the EU market.
Different fees may cause different conditions for operators in different MS. An effort was made to
harmonise fees for variety registration and PRM/FRM certification was proposed in the 2013 PRM
proposal. It was based on the principle of cost recovery and the exemption of microenterprises but
did not receive any support. The overall opinion was that the PRM/FRM legislation should not
cover fees, even by the principle of cost recovery, because the cost structures differ between MS,
the level of salaries being the main difference.
In relation to FRM, the creation of a voluntary coordination group for collaborative production,
pooling and exchange of FRM was considered as an alternative measure to better address potential
major shortages in the supply of FRM caused by extreme weather, disasters or any other event.
Stakeholder consultations revealed that the situation differs between MS with some being largely
self-sufficient and not yet having experienced any events that have led to shortages. A number of
respondents from across stakeholder categories informed that difficulties in FRM supply may partly
be due to a lack of planning and communication across the supply chain. It was therefore decided to
require that MS prepare national contingency plans.
Likewise, the creation of a voluntary inventory was considered an alternative measure for providing
information to FRM users/buyers about the suitability of FRM for climatic and ecological
conditions. Most respondents from across stakeholder categories were in favour of such a measure,
but opinions were evenly split on whether this voluntary inventory should be organised at EU or
national level. As most stakeholders fear that an EU inventory would increase the administrative
burden for NCAs and operators, it was opted to make such information available through websites,
planters’ guides and other appropriate means.
6.
W
HAT ARE THE IMPACTS OF THE POLICY OPTIONS
?
Due to the complex nature of the options, the assessment of the impacts will be guided by the
defining elements of the options
126
and a further distinction between PRM and FRM before
assessing the total combined impact of each policy option. The assessment is mainly based on the
data which was collected for the PRM study
127
and through two external supporting studies
128
. This
was supplemented by feedback and consultation with the stakeholders as well as further in-house
126
Strengthened sustainability requirements, OCs, conservation and sustainable use of plant and forest genetic
resources and innovation and digitalisation
127
SWD(2021)90.
128
ICF(2021) and ICF(2023).
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calculations. While the outmost effort was undertaken to collect as much as possible quantitative
data e.g. by targeted questionnaires, it must be noted that a quantitative assessment of the potential
economic, environmental and social impacts of each of the retained options was not always
possible. This section summarises the main impacts. Details on the methodology, the limitations of
the available data as well as a detailed assessment of all elements and their economic impacts are
available in Section 8 of Annex 4.
6.1.
Economic impacts
6.1.1.
Common measures to policy options 1-3
For the common measures of policy options 1-3, the
simplification of existing administrative
procedures
will result in a reduction of administrative burdens for NCAs and operators (same
impacts for options 1-3):
Professional operators will be required to be registered in a single register under the PHL.
This measure will not result in new costs as currently professional operators are registered
either under the marketing Directives, or PHL, or both. Over 20 000 duplicate registrations
will be avoided and over EUR 800 000 annual savings in registration costs for operators
supplying PRM of fruit plants. Over 4 000 duplicate registrations will be avoided and there
will be over EUR 237 000 annual savings in registration costs for operators supplying FRM.
Electronic notification by MS to the EU Plant Variety Portal of on average 4 000 new
varieties per year will avoid the handling of those notifications (Commission Decision and
publication in the Official Journal) and speed up access of those varieties to the EU market
by 1 to 4 months
129
. In turn, faster market access will have a positive impact on the
competitiveness of the EU PRM sector.
Allowing MS to authorise the temporary marketing of seed that does not satisfy the
requirements as regards the minimum germination rate, will avoid the handling by on
average 30 notifications per year. The waiting time for operators to use this seed will be
reduced by at least 15 days. Such notifications concern 50 000 tonnes of seed or 0.01% of
the quantity of seed certified annually.
Extending the possibilities for operators to carry out activities under official supervision
(PRM and FRM) is not expected to have significant impacts on enforcement costs for
NCAs
130
(Annex 4, Section 3). There will be no effect on the administrative burdens for
operators as regards certification and variety registration, as the administrative steps remain
the same. The measure is already applied by 10 MS under temporary experiments since
2012
131
. A permanent implementation would bring potential annual cost savings for
operators of around EUR 1.7 million across the EU (Annex 4, Section 3).
The possibility to deviate from certain DUS requirements as regards uniformity will be
provided for the DUS examination of organic varieties suitable for organic production. The
breeding period of varieties compliant with reduced uniformity requirements can be in
average 2 years shorter than for varieties fully meeting the uniformity requirements.
129
130
There are no data allowing the monetisation of these benefits.
This will require a reallocation of resources of NCAs from official examinations to official supervision and training
activities. The overall impact is neutral.
131
Commission Implementing Decisions 2012/340/EU and 2020/1106.
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Operators making use of this possibility will therefore access the market faster, with
reduced breeding costs and with varieties that up to now were restricted from the market
since it was not possible to register varieties not meeting the DUS requirements. A few
dozen operators across EU are likely to use this option. The number of varieties registered
under these rules could be in average 100 annually. Assuming EUR 50 000 savings in
breeding costs per variety, concerned operators may see savings of EUR 5 million annually.
The scope for heterogeneous material is broadened beyond organic production. This
measure creates a new market segment. Potentially a large number of operators may benefit
but the quantities of PRM concerned are expected to be very limited and of insignificant
market value
132
.
The rules for conservation varieties are lighter and extended to cover new locally adapted
varieties. This measure creates a new market segment. Operators would benefit from lighter
procedures for access to market (no DUS/VSCU requirements for variety registration and
no certification of PRM). The number of operators concerned could be in the range of
several hundreds. The number of varieties marketed under these rules could be a few
hundred annually. However, the quantities of PRM concerned are expected to remain
limited and below 2% of the market
133
. The potential market value could be up to EUR 13.3
billion /year * 2%= EUR 266 million/year.
6.1.2.
Strengthened sustainability requirements
This section examines the potential additional costs and benefits for operators, NCAs and users of
PRM/FRM due to the inclusion of requirements for assessment of sustainability characteristics in
the registration of new plant varieties (PRM) and basic material (FRM).
Operators
For the PRM sector, the envisaged measures for strengthening sustainability requirements in VCU
for agricultural plant species and vine and for introducing sustainability requirements in the
examination of new varieties of other crops (vegetables and fruit plants) will result in additional
testing costs for operators due to increased fees paid to NCAs for the examination of new varieties
(Table 3). The additional possibilities under options 2 and 3 for conducting the VSCU examination
under official supervision and for collaboration between NCAs on these will mitigate the additional
testing costs for operators. It is assumed, on the basis of a trend observed for certification under
official supervision, that 44% of all VSCU examinations will be carried out under official
supervision. Costs for operators are assumed to be 12% less for carrying out activities under official
supervision in comparison to the costs they have under official examinations
134
. The savings will
partly compensate the expected increase in the testing costs due to strengthened sustainability
requirements (Table 3).
132
Based on the experience gained by the implementation of the provisions on organic heterogeneous material under
Regulation (EU) 2018/848.
133
Based on the experience gained by the temporary experiment providing for certain derogations for the marketing of
populations of the plant species wheat, barley, oats and maize. Final report available at
https://food.ec.europa.eu/system/files/2022-04/prm_temp-exp_pop-exp_en.pdf
134
Calculated by ICF (2023) on the basis of survey results.
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Increase in variety registration cost for operators
Baseline Option 1
Option 2
Option 3
Agricultural species
0
6%
6%
9%
Vegetable species
0
11%
92%
115%
Vine
0
9%
9%
14%
Fruit plants
0
9%
101%
110%
Total annual increase in variety registration costs for operators
0
2.45
6.75
8.39
EU27 (million EUR)
Total annual increase in variety registration costs for operators
0
N/A
6.40
7.95
EU27 (million EUR) if 44% of VSCU examinations are carried
out under official supervision
Table 3. Cost increases for operators for registration of new varieties due to the assessment of sustainability
characteristics (for detailed calculations see Annex 4 Section 4).
It is important to note that these testing costs including strengthened sustainability considerations
are negligible as they represent only about 1% of the total cost for developing a new plant
variety
135
. The increased requirements for characteristics contributing to sustainable production
could however lead to a reduction of the number of varieties being accepted. For agricultural and
vegetable species up to about 4 000 varieties less could be made available in the EU market over a
period of 10 years because of the strengthened sustainability requirements (Table 4), but this
system will be necessary to avoid that varieties without improved characteristics contributing to
sustainable production will enter the market. The position of SMEs with a small number of
applications for new varieties per year could nevertheless be negatively affected in the short term,
with the need to re-orient investments in varieties with improved sustainability characteristics
136
.
Option 1
Option 2
Option 3
Additional
Additional
Additional
withdrawal
withdrawal
withdrawal
and/or
and/or
and/or
rejection
rejection
rejection
rate 3%
rate 5%
rate 10%
Agricultural plant species
2 564
2 487
2 435
2 308
Vegetable species
1 384
1 342
1 315
1 246
Vine
41
40
39
37
Fruit plants
39
38
37
35
Table 4. Average number of new plant varieties registered per year. The baseline is the average number of
new plant varieties registered annually over the period 2012-2021 as retrieved from the Common
Catalogues. Details on the assumptions on which the calculations are based can be found in Annex 4
Section 2.
Average number of new
plant varieties registered
per year
Baseline
In the FRM sector, the extension of the assessment of sustainability characteristics is expected to
lead to a negligible increase of costs for operators under all options 1-3 (Table 5)
137
. New basic
135
Total testing costs in the range of EUR 10 000 and total costs for developing a new variety in the range of 1 000 000
EUR. This value represents all costs (labour, infrastructure, land etc.) over the 10-12 years needed for the development
of a new variety.
136
There is no data available on allowing estimating the magnitude of this impact, in particular because several
varieties are being registered without actually being made available on the market by the applicants.
137
Increased testing (inspection) costs arise because of the need to assess more characteristics under all categories.
Inspection of the lowest FRM category currently does not include sustainability characteristics. More characteristics
will be included in the assessment of higher categories. For all categories it will also be required to indicate for which
area the FRM is suited/adapted.
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material is on average registered every 5 years and the budget spent by operators on the registration
of basic material is estimated to be less than 1% of their total revenue
138
.
Total annual cost
increase for operators
for registration of
basic material in
EU27
EUR
Baseline
Option 1
Option 2
Option 3
0
3 280
6 560
9 841
Table 5. Estimated annual cost increase in EU27 for the registration of new basic material due to the extension of
assessment of sustainability characteristics of basic material to the lower FRM categories, based on an average of 44
applications per year. Detailed calculations are available in Annex 4, Section 6.
Under option 1
non-forestry purposes
will be defined in the legislation, however these would not
be included in the scope of the legislation. It would be up to MS which non-forestry purposes
would be included, thus increasing or decreasing the FRM covered by the scope of the legislation
with a potential increase of testing costs in some MS
139
. Under options 2 and 3 the extension of the
scope of FRM legislation to include the production of FRM for specific non-forestry purposes
(common measure), will result in an increase in
testing costs
(for certification)
for operators.
This
increase would be more pronounced in those MS where the non-forestry purposes to be added in
the scope of the FRM legislation are currently not within the scope of the current national
legislation
140
. While there is insufficient data and evidence to allow an estimation, it is expected
that the impacts on all options will be limited
141
.
The measures contributing to sustainable production will not have an impact on administrative
burden for operators, as the administrative requirements for the registration of varieties under the
PRM legislation and for registration of basic material under the FRM legislation remain the same
under all options in relation to the baseline.
NCAs
The measures will result in additional
enforcement costs for the NCAs.
In options 1-3 due to the
introduction of strengthened sustainability characteristics there will be additional costs for carrying
out the examination of new varieties For
agricultural species and vine,
there will be no need for
additional testing stations for VSCU examinations. It will only be necessary to increase the number
of characteristics assessed during the VSCU examination in comparison to the current VCU
examination
142
. For new varieties
of fruit plants and vegetables,
under
options 2 and 3,
NCAs
138
139
Based on the data provided by 2 respondents in the targeted survey by ICF (2023).
By explicitly defining what is a non-forestry purpose, some MS may take out certain non-forestry purposes that are
currently included in the scope of their legislation. This could even decrease costs but also risks reducing quality.
140
Indicatively in 7 out of 11 MS that provided data non-forestry purposes are currently not within the scope of the
FRM legislation.
141
Information collected by the targeted survey under ICF (2023) indicates that only 10% of FRM produced
corresponds to non-forestry purposes.
142
It has not been possible to collect an overview of the situation in all MS as regards the assessment of sustainability
characteristics under the current VCU provisions. For example, France has already included several sustainability
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will have to increase up to 50% their capacity in areas and staff, including the need for additional
testing stations. The total annual cost for the NCAs would be in the range of EUR 43 to 98 million
in options 2 and 3 depending on the percentage of operators that will opt for official supervision.
The cost for NCAs under option 1 will be insignificant because it does not require an increase in the
capacity of the existing VCU testing stations (Annex 4, Section 5).
In the FRM sector, the extension of the assessment of sustainability characteristics is expected to
lead to higher
enforcement costs for NCAs.
These will however be negligible for options 1-3
because the measure concerns on average only 44 applications per year in EU27 for the registration
of basic material.
The extension of the scope of the FRM legislation to cover non-forestry purposes (not included
under option 1, but under options 2 and 3) may result in some increase of costs for NCAs (up to
10%-increase in number of applications for certification of FRM
143
).
The requirement for MS to prepare
national contingency plans
aims to ensure the availability of
FRM in case of major losses due to extreme weather or disasters. MS will have to set up such plan
once and update it as appropriate in view of evolving conditions. The resulting costs are expected to
be highest under option 3, whereby there will be common requirements on contingency planning
for all MS, therefore risking that NCAs will also have to address issues that are not relevant for
their MS. The additional costs would be lowest under option 1, as it will depend on the MS
decision to prepare a contingency plan (voluntary approach). The costs in all options are however
not considered significant as the MS already take similar measures
144
.
Users of PRM and FRM
The increased costs for operators (breeders) caused by extension of the
sustainability
requirements
in variety registration (leading to less varieties reaching the market) is expected to
result in increased prices of PRM for their users (mainly farmers). This is assumed to result in an
additional increase of the prices of PRM by 1% for option 1, 3% for option 2 and 5% for option 3.
Assuming other factors influencing the costs of inputs do not change, these additional costs would
correspond to an increase of overall costs of inputs for farmers
145
below 0.3% every year in all
options, but would gradually reduce over the years as breeding programmes would adjust to the
new requirements. Therefore, cascading impacts on the competitiveness of farmers and food prices
due to the above-mentioned increases in price of PRM are estimated to be marginal. Furthermore,
the resulting varieties with improved characteristics should result in a more stable agricultural
output under fluctuating conditions and thus contribute to food security and the competitiveness of
farmers. The avoided losses of production would compensate for the increased costs of PRM, with
option 2 resulting in a net benefit for farmers ranging between EUR 221 million and 2.1
characteristics in the VCU examination. Other MS (e.g. Germany and The Netherlands) focus on yield and disease
resistance/tolerance but are already working towards a more comprehensive assessment of sustainability characteristics.
143
ICF(2023) survey data showed that in MS producing FRM for non-forestry purposes (e.g. France, Germany and
Poland) this covers on average up to 10% of all FRM produced.
144
According to information collected through the interviews by ICF (2023), Finland and Sweden already have
contingency plans in place, while Slovenia and Spain are undertaking efforts to improve contingency planning.
145
Referred to in Eurostat as ‘Intermediate consumption in agriculture’. It includes fertilisers, pesticides, seeds and
other inputs.
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billion annually,
option 1 resulting in a net benefit for farmers ranging between EUR 177 and 1
110 million annually and option 3 resulting likely in benefits under an “optimistic” scenario (EUR
1 198 million annually) and in negative balance (EUR -201 million annually) under a more
“conservative” scenario (Table 6 and Annex 4, Section 5).
Million EUR
(current
2021 price)
INCREASE IN COSTS
Total annual PRM cost in
agriculture
Total annual PRM cost in relation
to cost of all inputs in agriculture
BENEFITS
Total annual crop output
Balance / optimistic scenario
Total annual crop output
Balance / conservative scenario
Impact on farms of strengthened
sustainability requirements for the
acceptance of new varieties of PRM
Option 1 Option 2 Option 3
1%
133
0.05%
0.50%
1,243
1,110
0.125%
311
177
3%
400
0.15%
1.00%
2,487
2,086
0.250%
622
221
5%
667
0.26%
0.75%
1,865
1,198
0.188%
466
-201
13,346 Increase in total
PRM cost
in agriculture (%)
(million EUR)
Increase in
global cost of inputs
in
260,168 agriculture due to increase in PRM cost(%)
248,657 Avoided loss in crop output annually (%)
(million EU)
million EUR
248,657 Avoided loss in crop output annually (%)
(million EU)
million EUR
Table 6. Costs and benefits for farmers due to strengthened sustainability requirements for the acceptance of new
varieties of PRM. Detailed calculations are presented in Annex 4 Section 5.
As the extension of the assessment of sustainability characteristics and the extension of the scope of
FRM legislation to include the production of FRM for specific non-forestry purposes is expected to
lead to a marginal increase of costs for operators and NCAs in the FRM sector, the impacts on
FRM users in terms of price will be negligible. FRM may however experience reduced economic
losses by using more suitable FRM, but these benefits cannot be quantified
146
.
6.1.3.
Official controls
Currently there are significant differences between MS as regards the total number and type of OCs
carried out
147
. The impact of the harmonisation of OCs will differ between MS depending on their
current implementation of OCs.
Operators
Under options 1 and 2, the harmonisation of the current requirements
148
will not introduce new
obligations for operators.
Under options 1 to 3, passing from a combination of random checks and risk-based controls to risk-
based controls will allow OCs to be carried out in a more focussed and efficient way. This will be a
fairer system in comparison to the baseline, because operators will be subject to OCs depending on
their risk profile. As a result, individual operators could either be subject to a lower or higher
146
147
ICF(2023).
Described in section 2.1.1.
148
Import controls, marketing controls and production controls on operators carrying out certification under official
supervision.
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number of OCs in comparison to the baseline situation, especially when currently OCs are carried
out only randomly. Consequently, the overall impact on operators will be neutral.
Under option 3, operators that are importing PRM/FRM into the Union will in addition be required
to submit special import documentation and be subject to OCs at border control posts. NCAs will
also have increased costs under option 3 for carrying out these OCs, which most likely will be
transferred to operators in the form of fees. Therefore, those operators who import PRM/FRM into
the Union will face increased administrative burden and costs (fees). These cannot be calculated as
there is no information available on the number of operators and transactions concerned. The
overall impact under option 3 on operators is considered as moderate negative as not all operators
are concerned by the OCs on imports.
NCAs
Depending on the baseline situation per MS, under options 1 to 3 the harmonisation of the
requirements for OCs may lead to
increased enforcement costs and administrative burden for
NCAs.
Such costs will be due to the obligations to draft multi-annual control plans and report
annually on OCs. There can also be one-off costs linked to potential need for reallocation of
resources in order to adjust to the new requirements for risk-based OCs. NCAs may also need to
increase or decrease the frequencies of OCs. These impacts overall are considered to be neutral for
the NCAs in total.
Option 3 however entails additional costs for the NCAs in comparison to options 1 and 2 because
under option 3 OCs on imports will be carried out at border control posts. This requirement would
mean that NCAs would have to equip the border control posts with additional staff to carry out the
sampling of imported PRM/FRM. There are about 500 border control posts across the EU
designated for phytosanitary controls under the PHL. Assuming that these would also be designated
for PRM/FRM, they would need to be equipped by staff to carry out sampling of imported
PRM/FRM. With 1 person in average by border control post at EUR 30 000 for salary, the total
annual cost under option 3 for NCAs amounts to EUR 15 million (not occurring under options 1
and 2).
As regards benefits, under options 1 to 3, the introduction of the risk-based approach will lead to
better focus the OC activities of the NCAs on where most needed, therefore there will be overall
efficiency gains.
Moreover, options 2 and 3 will provide additional efficiency gains in comparison
to option 1 due to the inclusion the OCs on PRM/FRM in the scope of the OCR. This will allow the
use of common IT applications for reporting on OC
149
and for exchanging on fraud matters
150
, as
well as opportunities for training (Better Training for Safer Food programme). It will also allow to
align the OCs on PRM/FRM with those under other legislative frameworks already within the
149
IMSOC is the information management system for official controls under the OCR. In COM(2021)786 final on the
experience with the implementation of PHL, it is reported that the use of TRACES-NT (part of IMSOC) can be
considered an important improvement brought by the OCR. The functionality offered to notify non-compliances at
import was declared as effective by 80% of the respondents. The interconnection with other systems, the user-
friendliness and the availability of information was also rated positively.
150
A secure IT system that would allow the exchange between MS of confidential information on fraud matters related
to PRM/FRM is currently not in place. Inclusion in the scope of OCR would allow for these purposes the use of
iRASSF, that allows secure exchanges on food and feed safety alerts.
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scope of the OCR which might be applicable also to PRM/FRM, as the case may be (PHL, Organic
Regulation and GMOs)
151
. Such efficiency gains are not possible under option 1.
Finally, measures aiming to increase the
coherence between the PRM/FRM legislation and the
PHL
is expected to lead to a reduction of
administrative burden for operators
and
enforcement
costs for NCAs to carry out OCs
(Annex 5, Section 7) depending on how the MS distribute the
competences for PRM/FRM and PHL
152
.
6.1.4.
Conservation and sustainable use of plant and forest genetic
resources
To contribute to biodiversity and increase the genetic diversity of PRM and FRM, there will be
adapted rules for activities of seed conservation networks, exchange in kind of seed and marketing
to amateur gardeners in the PRM sector and for the registration of basic material in the FRM sector.
Operators and NCAs
There will be a reduction of administrative burdens under options 1 and 2 for operators involved in
seed conservation networks, marketing to amateur gardeners and exchange in kind of seed between
farmers due to the exemption from the scope of the legislation, but given the limited volume of seed
involved
153
, the absolute magnitude of such reduction in relation to the whole seed sector is not
significant. Under option 2 lighter rules still present a reduced administrative burden in comparison
to the baseline. Those rules ensure a minimum level of quality and traceability which would in
particular be important for marketing to amateur gardeners. They would allow for the
documentation and characterisation of plant genetic resources, thus maximising their contribution
to more resilient agri-food systems. Under option 3 the administrative burden remains unchanged in
comparison to the baseline. Finally, it is assumed that mostly SMEs and, in particular small-scale
local operators, are involved in such activities. They benefit from the exemptions and derogations
to be introduced for varieties marketed exclusively to amateur gardeners, conservation varieties
151
A report on the experience with the implementation of PHL (COM(2021) 786 final) sought to collect data on the
savings caused by simultaneous controls on QPs and RNQPs upon import but the low response rate did not allow
monetising those savings.
152
In 12 out of 27 MS the inspections for RNQPs have been delegated to the NCA responsible for PRM certification.
153
Though the total numbers across the EU are not known, there is no indication that the volumes of PRM distributed
by seed conservation networks and farmers engaged in exchange in kind of seed or of PRM marketed exclusively to
amateur gardeners have a significant share of the EU PRM market. Furthermore, most of the PRM marketed to amateur
gardeners belongs to varieties that are also available for professional operators. Marketing to amateur gardeners can be
ascertained only if seed is marketed in small packages, which are relatively too expensive in comparison to larger
packages and therefore not used by professional operators. Currently only “vegetable varieties developed for growing
under particular conditions” are subject to such limitations to the size of packages and can be considered as marketed
exclusively to amateur gardeners. Such varieties represent less than 5% of the varieties in the Common Catalogue for
vegetables. Operators marketing varieties addressed to both professional users and amateur gardeners (i.e. the vast
majority of varieties in the market) will not be able to benefit from the reduction of administrative burden under options
1 and 2 as regards marketing exclusively to amateur gardeners. It is considered unrealistic that for the same variety
operators would start having separate production lines for PRM to be sold to amateur gardeners and for PRM to be sold
to professional operators (ICF(2023) Section 5.1.2).
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including locally adapted varieties, organic varieties suitable for organic production and
heterogeneous material.
Exempting the marketing of PRM to amateur gardeners from the scope of the legislation could
result in a lower PRM quality and lead to an increase of fraudulent practices if that PRM is
marketed to professional users (option
1).
Even though exchange in kind of seed between farmers
is considered to be a marginal activity (see above), there could be a potential negative economic
impact on seed companies if this activity is exempted from the scope of the PRM legislation
(option
1).
Such exemption would also allow in particular large farms and farmers’ cooperatives
currently operating as seed multipliers to place on the market big quantities of seed without the
obligation to meet the certification requirements and thus have an unfair competitive advantage
over the companies marketing seed. There would be a negative impact on those companies, and
particularly on SMEs that are most likely to work with non-hybrid varieties that can be easily
multiplied. Under option 2, an overall positive economic impact is expected because lighter rules
will prevent fraudulent practices, enhance traceability and ensure a minimum PRM quality. Under
option 3, benefits are minimal because activities of seed conservation networks, exchange in kind
of seed and marketing to amateur gardeners would be subject to variety registration and PRM
certification.
In the FRM sector there will be
no additional costs and administrative burden for operators
and NCAs
as regards the measures for the purposes of conservation and sustainable use of forest
genetic resources under option 1. Options 2 and 3 will
reduce the administrative burden for
operators and NCAs
because there will be a notification for the purposes of the conservation of
forest genetic resources instead of a fully-fledged registration process.
6.1.5.
Operators and NCAs
BMTs can be used to speed up the characterisation of new varieties and facilitate identification in
PRM placed on the market. Digitalisation will improve the efficiency, integrity and traceability of
the PRM/FRM certification and labelling system, making the certification process more efficient.
Setting out a framework (implemented either by guidelines in option 1, or common rules in options
2 and 3) on the use of innovative production processes, BMTs and digital solutions will create legal
clarity for operators and NCAs. It is expected to encourage NCAs and operators to invest in
these
154
, with a
positive impact on innovation and research
(Annex 5, Section 8). The measures
under options 1-3 will provide new opportunities but not new obligations. Therefore, there are no
costs imposed. Use of these new options however may require investments in equipment and/or
staff. Any investment is expected to be recovered within few years due to efficiency gains and
lower costs of operations (Annex 4, Section 7).
Innovation and digitalisation
154
Absence of such framework has been evoked in replies to the targeted survey by ICF(2023) as creating legal
uncertainty for NCAs that prevents them from using BMTs. Other NCAs reported that they already use BMTs for
variety identification and official inspections. Operators reported that BMTs are already used for plant breeding
purposes (though this aspect is out of the scope of the PRM legislation), while in the FRM sector some companies have
specialised in innovative production processes.
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It is likely that initially not all SMEs would be able to benefit to the same degree as larger
companies from the new opportunities given for the use of innovative production processes, BMTs
and digital solutions
155
. Gradual reduction in investment costs and increase in the use of BMTs
156
and digital technologies is expected to quickly reduce this gap. The
long-term benefits
would
anyway outweigh the initial investments. In turn, such investments are expected to
reduce costs for
both NCAs and operators
for examinations for variety registration, PRM/FRM certification and
marketing controls. Depending on the activity they specialise in and their current research and
development intensity, some SMEs could be able to benefit from the new options more easily.
6.1.6.
SMEs
Most of the 7 000 enterprises active in the seed sector in the EU are assumed to be SMEs. As
regards PRM of fruit plants, there are over 20 000 suppliers in the EU, almost all of which are
SMEs. As regards FRM, there are over 4 000 suppliers in the EU, almost all of which are SMEs.
SMEs in the PRM/FRM sectors are very diverse in their activities and the degree of R&D intensity,
but there is no comprehensive information available on the breakdown between the different
activities. Some are highly specialised e.g. in breeding vegetable hybrids for only a few (or even
one) species, in organic varieties, or in rapidly producing FRM clones through somatic
embryogenesis. Others are just multiplying seed. The evidence available for the different activities
of the SMEs is insufficient for a detailed assessment of the impact of the policy options on those
SMEs.
An SME survey was carried out as part of the consultation activities. This confirmed the diversity
of SMEs’ activities and the variable impact that proposed measures may have on SMEs. The replies
however did not indicate that SMEs could be disproportionately affected in relation to larger
companies by the envisaged measures under the different options. Depending on the activity they
specialise in and their current R&D intensity, some SMEs could be able to adjust more easily to the
new obligations and benefit from the new opportunities. It would be however mostly SMEs that
would benefit from the exemptions and derogations to be introduced for varieties marketed
exclusively to amateur gardeners, conservation varieties including locally adapted varieties, organic
varieties suitable for organic production and heterogeneous material, as it is mostly SMEs that are
involved in such activities. Therefore option 3 that is most restrictive in these aspects can be
assumed that it provides the least benefits for SMEs.
6.1.7.
Competitiveness
All options are expected to improve the
functioning of the internal market
by increasing
harmonisation and therefore more uniform application of requirements for operators across the EU,
for both the PRM and FRM sectors. The highest harmonisation would be achieved in option 3 but
possibly to a counter-productive degree as in option 3 most flexibility for Member States to adjust
implementation to specific conditions would be lost. The policy options considered are not
155
Replies to the SME questionnaire indicate that the majority of SMEs considers that digital solutions and use of
BMTs would bring advantages for them but would require additional investments in terms of access to third-party
services, additional staff, training and/or infrastructure. A quantification of these investments is not possible.
156
Costs are diminishing quickly and related technology becomes more accessible, but also improves. E.g. cost of
genome sequencing from 1980s to today has diminished 1 000 fold, while the potential applications are multiple since
then.
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expected to have any significant impact on
imports and exports
of PRM and FRM. PRM and FRM
imported from third countries is treated in the same way as the material produced in the EU. The
principle remains that equivalence with EU requirements is given to third countries and imports are
allowed if PRM/FRM produced in third countries meet the requirements of the EU legislation.
Particularly for imported seeds, these must be of a variety already accepted in the EU Common
catalogues. To be accepted, the variety has to be examined successfully by a MS according to the
EU variety registration requirements. FRM can be imported from member countries of the OECD
Forest Seed and Plant Scheme if the seed and planting stock fulfil the conditions set out by the EU
legislation. PRM and FRM intended for export to third countries are not subject to the EU rules,
while in all options the EU rules remain compatible to relevant international standards as OECD
Seed Schemes, ISTA and WTO/SPS. Overall, efficiency gains from the various measures
(increased coherence with PHL, OCR, a clearer framework for BMTs, innovative production
processes, digitalisation) will have a positive impact on competitiveness of operators, that will be
maximised under option 2.
6.2.
Environmental impacts
Baseline
0
Policy Option
1
+/-
Policy Option
2
++
Policy Option
3
+
Environmental impacts
Availability of PRM/FRM suitable to address
sustainability, climate change and biodiversity
objectives
Conservation and sustainable use of plant and
0
+
++
+/-
forest genetic resources
Table 7. Environmental impact of PRM/FRM measures
The scale corresponds to the following scheme: ++ positive impact, + moderately positive impact, +/-
inconclusive/uncertain impact, = no significant impact, - moderate negative impact, --significant negative impact.
6.2.1.
Strengthened sustainability requirements
The significant impact of rapidly changing conditions highlights the importance of varieties with
improved sustainability characteristics. The positive
environmental impact
of such varieties may
also contribute to the objectives of other policy initiatives (F2F, Biodiversity Strategy and
Adaptation Strategy). Over the period 1981-2010, the average annual crop losses caused by drought
in the EU have been estimated at EUR 4.8 billion/year
157
. Drought projections show that the maize
sector may collapse at 2ºC of global warming if there would not be enough water available for
irrigation. In Europe grain maize is projected to be the crop that is most affected by climate
change
158
. Agro-climatic zones are moving northward and it is expected that this will further
accelerate under climate change
159
. As a consequence, crops may no longer be suitable for the
changing agro-climatic conditions
160
. Varieties with improved sustainability characteristics (e.g.
drought tolerance
161
) would contribute to a more sustainable yield that would in turn contribute to
157
158
https://joint-research-centre.ec.europa.eu/peseta-projects/jrc-peseta-iv
Hristov
et al.
(2020), Toreti
et al.
(2022).
159
Ceglar
et al.
(2019).
160
Ceglar
et al.
(2021).
161
Luo
et al.
(2019).
50
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food security. Under option 1, the voluntary approach for the assessment of sustainability
characteristics in vegetables and fruit plants, may result in PRM that is not suited for the local agro-
ecological conditions. Under options 2 and 3, the mandatory assessment of sustainability
characteristics in vegetables and fruit plants and the strengthened sustainability requirements of
agricultural species and vine will have a positive
environmental impact.
The international
organisation for vine and wine recommends the development of a specific examination of vine
varieties present in different geographic zones with the aim to improve the knowledge about the
adaptation potential of vine varieties
162
. They recognise the importance of the conservation and
recuperation of genetic resources to develop new vine varieties that may contribute to adaptation to
climate change.
Apart from the migration of climate zones, climate change also has an impact on the host range and
geographical distribution of certain plant pests
163
. Certain pests may pose a danger for agricultural
crop protection (e.g.
Meloidogyne graminicola
on rice) necessitating the EU to impose emergency
measures
164
. Varieties with disease resistance / tolerance as a sustainability characteristic will have
a positive
environmental impact
and may reduce the need for plant protection products. Varieties
with strengthened sustainability characteristics may also contribute to the availability of PRM that
is more suitable for the current and future projected climatic conditions.
The
environmental impact
of the strengthened sustainability considerations for FRM is interlinked
with the impacts of other policy initiatives (Biodiversity Strategy, new Forest Strategy and
Adaptation Strategy). By the end of the century, climate change will substantially alter the current
distribution of climatically suitable areas for the majority of European trees
165
. FRM with improved
sustainability characteristics can contribute to adaptation and mitigation of the already visible
impact of climate change on forests such as drought, wildfires, increased vulnerability to climate-
driven disturbances
166
. Strengthened sustainability requirements under options 2 and 3 will increase
to the availability of FRM contributing to
sustainable forest management and restoration of
healthy forest ecosystems.
Option 2 overall performs very well in terms of the positive environmental impacts of strengthened
sustainability requirements in the PRM and FRM sectors. Option 3 shows weaknesses because the
creation of fully harmonised conditions for MS will limit possibilities for adjustments by MS to
their own agro-ecological and environmental conditions, which is a key aspect in terms of
contribution to sustainable agri-food production and forestry.
The extension of the scope of the FRM legislation to cover
non-forestry purposes
(options 2 and
3) will have a positive
environmental impact
especially in those MS where non-forestry purposes
are significant
167
and currently not within the scope of the legislation. The long-term losses caused
162
163
OIV (2021).
IPPC Secretariat. 2021.
164
Commission Implementing Regulation (EU) 2022/1372.
165
Mauri
et al.
(2022).
166
Schuldt
et al.
(2020), Büntgen
et al.
(2021), Müller et al. (2020), Choat B.
et al.
(2012), Forzieri G.
et al.
(2020),
Forzieri G.
et al.
(2021).
167
Spain, Greece, France and Italy have a significant agroforestry cover.
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by the planting of lower quality FRM would be reduced
168
. Even when FRM for non-forestry
purposes is planted close to certified FRM there will no longer be any risk that it will lower the
quality of the certified FRM, thus resulting long-run impacts on the resilience of forests are
avoided. For all of the above, evidence is insufficient to allow a quantification of the described
impacts.
National contingency plans
(options 2 and 3) should address difficulties in supply of FRM in a
more comprehensive way. National contingency plans will reduce the need for authorising the use
of lower quality FRM, which would in turn help reduce canopy cover loss and contribute to the
creation of resilient forests supporting biodiversity and mitigating climate change. In the absence of
a requirement for contingency planning (option 1), it is less likely that MS will develop national
contingency plans, but some MS have already done so or are in the process of doing so. Therefore,
under option 1 the reduction of canopy cover loss would be low, while under options 2 and 3 it
would be high. Difficulties in supply of FRM combined with the use of lower quality FRM can
result in delayed planting and have a negative impact on the resilience of forests and could
ultimately result in a loss of 5% of the total canopy cover
169
.
More and better information on the suitability of FRM for current and future climatic conditions
under all policy options will have a positive
environmental impact
through the selection of the
right tree for the right place and thus support the resilience of future forests. It would also benefit
users of FRM. Access to information about FRM characteristics would allow users to select the
most appropriate FRM and reduce economic damage caused by the use of unsuitable FRM.
Indicatively, incidences of entire forests disappearing due to bark beetle infestations caused by the
planting of monocultures of unsuitable tree species susceptible to bark beetles could be reduced
170
.
In the PRM and FRM sectors innovative production processes also offer big potential for
addressing new demands as regards
sustainability and environmental objectives
171
. Positive
impacts are expected to be maximised in option 2, under which general legal provisions will
provide a common framework that is on the one hand reliable and on the other hand flexible
enough. Under option 1 (guidelines) there is a risk that the rules will be fragmented and
requirements for operators will continue to differ across MS, with less environmental benefits.
Under option 3 (more detailed rules) there is a risk that the legislation will be too prescriptive and
become outdated very soon in light of new technical and scientific developments, thus nullifying
initial benefits.
168
In the 9 MS that provided data in the targeted survey, on average 10% of the FRM produced is used for non-forestry
purposes.
169
Thonfeld
et al.
(2022) In the period 2018-2020 4.9% of canopy cover was lost in German forests because of extreme
drought and tree species unsuitable for the environmental and climatic conditions.
170
Hlásny
et al.
(2021).
171
For example, true potato seed has great potential for genetic gains in potato breeding.
In vitro
propagation can
contribute to increasing the production capacity and therefore meet the increasing demand for FRM. Some MS are
exploring the use of new production processes to produce large quantities of FRM in a fast way. See for example Wu
(2019) and Rosvall (2019).
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6.2.2.
Conservation and sustainable use of plant and forest genetic
resources
Measures to conserve the genetic diversity of plant and forest genetic resources will alleviate the
pressure on agricultural production and forests caused by increased exposure to biotic and abiotic
factors. Genetically diverse PRM and FRM will have a positive environmental impact on the
resilience against extreme weather conditions and disasters.
For PRM, lighter rules for the activities of seed conservation networks, marketing to amateur
gardeners and exchange in kind of seed will also lead to
increased genetic diversity of cultivated
crops
and contribute to the
conservation and sustainable use of plant genetic resources.
Genetic
diversity of cultivated crops in turn can have benefits for
resilience
to a number of pressures (e.g.
climate change, plant pests). Genetic diversity is also essential for future breeding efforts to develop
new improved varieties
172
. A total exemption from the scope of the legislation (option 1) may cause
loss of genetic diversity due to a lack of identification and traceability of the PRM concerned while
the procedures in option 3 would be too cumbersome. Option 2 offers the best solution for
safeguarding genetic diversity as it introduces light rules ensuring the identification and traceability
of the PRM concerned.
In the FRM sector the environmental benefits regarding lighter rules for the registration of basic
material will be marginal under option 1 since the effect of guidelines will be limited without
changes in the requirements for the registration. By enabling the diversity of forest genetic
resources, policy options 2 and 3 will have a
positive environmental impact
on
biodiversity
and
adaptation to climate change.
Policy option 2 will provide the strongest incentive as it allows
operators to notify basic material instead of going through the official registration procedure
requiring verification by the NCAs. EU forests are fragile because currently, 32.8% of EU forests
have a single tree species, 49.5% have 2 to 3 tree species, 13.1% have 4-5 species and only 4.6% of
forests have more than 6 tree species
173
. The measures under option 2 will ensure and conserve
greater genetic diversity within a single tree species. It is estimated that the loss of canopy cover
caused by the planting of a single tree species could be reduced by 5%.
6.2.3.
Common measures for PRM to contribute to sustainability,
biodiversity and climate-related challenges
A number of common measures under all options will have a positive environmental impact.
Adapted rules on organic varieties suitable for organic production will contribute to the target of
having 25% of agricultural production under organic conditions pursuant to the
goals of F2F,
therefore indirectly contributing to reduced use of inputs in agriculture. Simplified requirements for
marketing of conservation varieties, extension of these requirements to cover new locally adapted
varieties and broadening the scope of heterogeneous material beyond organic production will also
reduce the administrative burdens for the operators concerned, but again not significantly in relation
172
Genetic diversity is crucial as it allows for the adaptability and resilience of the cultivated plants to climate change
and other pressures. It is also necessary for breeding new varieties, as it provides for a pool of genes out of which
breeders select according to new needs and challenges.
173
https://foresteurope.org/wp-content/uploads/2016/08/SoEF_2020.pdf
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to the whole sector
174
. Finally, it would be mostly SMEs that would benefit from such derogations,
as it is assumed that mostly SMEs and small local actors are involved in such activities.
6.3.
Social impacts
Under all options, lighter rules for conservation varieties and their extension to cover new locally
adapted varieties have the potential to create a new market segment. Several hundreds of operators
in rural areas could benefit from employment opportunities and a market that could reach an annual
value of EUR 266 million annually. Also the exemption from the scope (option 1) or lighter rules
(option 2) for activities of seed conservation networks, marketing exclusively to amateur gardeners
and exchange in kind of seed between farmers are expected to have a positive impact on
employment in rural areas, both in relation to SMEs in the PRM sector marketing these varieties
and to the development of local value chains
175
. Under all options, the harmonisation of OCs,
measures to improve the coherence with the PHL and extension of the activities that can be carried
out under official supervision will have marginal/neutral impacts on employment. This would be
restricted to reallocation of staff within the NCAs.
6.4.
Sustainability
The introduction of strengthened
sustainability considerations
in the
examination of new
varieties
will support
food security
176
, since better adapted varieties – future proof varieties - will
result in more stable yields. Similar contributions are expected due to the availability of organic
varieties suitable for organic production and new locally adapted varieties. Availability of seed of
such varieties will result in more stable agricultural production and ultimately food availability.
Finally, measures to support the conservation and sustainable use of plant genetic resources also
contribute to sustainability by maintaining a broad genetic pool that is necessary for the breeding of
improved varieties in the future. Currently food security in the short term is not an issue. However,
the sustainability and resilience of the food system should be reinforced to ensure food security in
the long term. The increasing frequency of extreme weather events will have a negative impact on
agricultural production and risks increasing the number of pest outbreaks while all these events will
potentially have an impact on food affordability
177
.
Under option 1, the reinforcement of sustainability requirements would be restricted to agricultural
crops and vine and would not contribute comprehensively to sustainability of food systems. Even
though this would have low economic costs in the short term, there will be a potential negative
economic impact in the long term. The environmental benefits would be limited because other crop
groups (vegetable species and fruit plants) would not be addressed. In the mid to long term this
would lead to increased crop losses and a negative impact on society because of expected
fluctuations in food availability and food prices. Option 2 would reinforce sustainability
requirements also in vegetable species and fruit plants. The overall benefits in terms of
174
175
Indicatively, in France locally adapted varieties of wheat represent 1% of volume.
Conservation and locally adapted varieties are often linked to local food chains, e.g. wheat for local bakeries. See for
example the final report on the Temporary experiment providing for certain derogations for the marketing of
populations of the plant species wheat, barley, oats and maize (Decision 2014/150/EU)
https://food.ec.europa.eu/system/files/2022-04/prm_temp-exp_pop-exp_en.pdf
176
FAO recognises the role of improved varieties for food security globally.
177
SWD(2023) 4 final.
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sustainability would be positive. In the mid to long term crop yields would remain more stable and
have a positive impact on society because of more stable food availability and food prices. Under
option 3, the overall benefits in terms of sustainability would still be positive but limited by the
reduced possibilities to adapt to local agro-ecological conditions.
The impact of climate change is already visible in the forest sector. Extreme weather events and
disasters are becoming more frequent. Vegetation zones are moving fast and without a policy
change, forests will not be able to cope with this
178
. As a result, forests will increasingly become
poorly adapted to the changing climatic conditions. Large parts of forests will be increasingly
destroyed by drought, storms, floodings, forest fires and heat while insufficient and poorly adapted
FRM will be available for reforestation of the damaged forests. In the FRM sector, the measures to
assess
sustainability characteristics
of basic material and the establishment of
national
contingency plans
(options 2 and 3) will contribute to sustainable afforestation and reforestation.
This will in turn result in more resilient forest ecosystems and contribute to forests that are better
adapted to climate change. Similar positive contributions are expected from the obligation to
provide information on FRM to users/buyers. Extending the scope of the legislation to non-forestry
purposes will have a long-term positive environmental impact by avoiding failure of forest
ecosystems (options 2 and 3). Measures on forest genetic resources will increase the genetic
diversity of FRM and therefore also contribute to more resilient forest ecosystems (options 2 and
3). Given the uncertainty around the future projected climatic conditions and the time needed for
the creation of new forests, it is important to ensure sustainable afforestation and reforestation by
planting high-quality climate-adapted and genetically diverse FRM. This will ultimately result in
resilient forest ecosystems that may withstand the pressures of climate change.
Under option 1, voluntary guidelines on the assessment of sustainability characteristics may result
in improperly assessed FRM reaching the market. If non-forestry purposes would not be included in
the scope of the legislation low-quality FRM may be planted close to high-quality certified FRM. In
spite of their low economic impact in the short term, there would be a significant negative
environmental impact in the long term (e.g. forests susceptible to pests or other environmental
pressures). Under options 2 and 3, measures on the assessment of sustainability characteristics and
the extension of the legislation to cover non-forestry purposes would have a slightly higher
economic impact. Already in the mid-term the benefits would outweigh the initial costs by avoiding
forest losses caused by the planting of low-quality and improperly assessed FRM. In the long-term
forest ecosystems would become more resilient and less vulnerable to climate-driven disturbances.
Under option 2 the benefit in terms of sustainability and contribution to genetic diversity would be
positive while under option 3 those benefits, while still positive, would be more limited by the
reduced possibilities for MS to adapt to their specific environmental conditions.
6.5.
Global combined impact of the policy options
Option 1 presents low economic costs for operators and NCAs but also low benefits due to
strengthened sustainability requirements. The increase in costs would be insignificant as few
adjustments would be required both for operators and NCAs. However, the voluntary nature of the
additional assessment of sustainability characteristics gives too much leeway, risking that varieties
without improved sustainability characteristics enter the market. This would in turn reduce the
178
Ceglar
et al.
(2019).
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contribution to more sustainable agri-food production and food security. Annual agricultural losses
already reach up to EUR 4.8 billion because of drought only. Without additional effort for varieties
better adapted to such extreme conditions this situation is expected to deteriorate even further. In
the FRM sector, the voluntary approach towards contingency plans may cause major shortages of
FRM in case of extreme weather and disasters. Leaving non-forestry purposes out of the scope of
the FRM legislation may result in the planting of low-quality FRM in proximity of high-quality
FRM, and in long-term impacts on the resilience of forests. Finally, option 1 is expected to have
positive impacts on the conservation and sustainable use of plant and forest genetic resources
though limited by the absence of tools for traceability and quality assurance for plant and the
voluntary nature of rules for forest genetic resources.
Option 2 presents considerable economic costs for operators and NCAs due to the need for
additional investments to conduct additional sustainability assessments. On the other hand, benefits
due to strengthened sustainability requirements are high as the mandatory nature of the additional
assessment is combined with flexibility to adapt to local agro-ecological conditions. This would in
turn increase the contribution to more sustainable agri-food production and food security. In the
FRM sector, the obligation for MS to establish contingency plans is expected to increase
preparedness for major shortages of FRM in case of extreme weather and disasters. The inclusion
of non-forestry purposes in the scope of the FRM legislation would reduce the risk of planting low-
quality PRM in proximity of high-quality FRM, and negative long-term impacts on the resilience of
forests. Finally, option 2 is expected to have high positive impacts on the conservation and
sustainable use of plant and forest genetic resources through tools for traceability and quality
assurance for plant and adapted rules for forest genetic resources.
Option 3 presents considerable economic costs for operators and NCAs due to the need for
additional investments to conduct additional sustainability assessments. Benefits due to
strengthened sustainability requirements are positive though limited by the lack of flexibility to
adapt to local agro-ecological conditions. This would in turn limit the contribution to more
sustainable agri-food production and food security. In the FRM sector, harmonised contingency
plans with lack of flexibility to adapt to local climatic and ecological conditions will limit the
benefits regarding increased preparedness for major shortages of FRM in case of extreme weather
and disasters. The inclusion of non-forestry purposes in the scope of the FRM legislation would
reduce the risk of planting low-quality PRM in proximity of high-quality FRM, and negative long-
term impacts on the resilience of forests. Finally, option 3 is expected to have negative impacts on
the conservation and sustainable use of plant genetic resources as measures concentrate on
increased traceability and quality assurance without fully accommodating the specific needs of
plant genetic resources. Harmonised rules adapted for forest genetic resources will have a positive
impact on the conservation and sustainable use of forest genetic resources.
The major cost and benefit elements of each option are summarised in Table 8.
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Costs
Increased costs for PRM operators due to
strengthened sustainability assessment
Increased costs for NCAs due to strengthened
sustainability assessment
Increased costs of PRM for farmers due to
strengthened sustainability assessment
Increased costs for NCAs due to measures on
official controls
Increased costs for operators and NCAs due to
measures for FRM (definition of purposes,
assessment for sustainability characteristics,
national contingency plans)
Benefits
Avoided loss in crop output due to increased
sustainability requirements
Reduction in costs of registration of operators
due to single registration under plant health
legislation
Reduction in PRM certification costs due to
extended scope of activities under official
supervision
Market opportunities due to lighter rules for
conservation varieties and new locally adapted
varieties
Reduction of breeding costs due to adjusted
uniformity requirements for organic varieties
Efficiency gains due to measures on official
controls
Efficiency gains due to measures on
innovation and digitalisation
Sustainability of agri-food production, forestry
and food security
Policy Option 1
2
=
133
=
=
Policy Option 2
6
43 to 98
400
=
=
Policy Option 3
8
43 to 98
667
15
=
Policy Option 1
310 to 1 243
1
Policy Option 2
621 to 2 486
1
Policy Option 3
466 to 1 864
1
2
2
2
266
266
266
5
+
+
+/-
5
++
++
++
5
++
+
+
Benefits for the conservation and sustainable
+
++
+/-
use of plant and forest genetic resources
Table 8. Overview of major cost and benefit elements of each option
The amounts are for EU27 in million EUR/year. For cost and benefit elements for which monetisation is not feasible, a
qualitative score is used. The scale corresponds to the following scheme: ++ positive impact, + moderately positive
impact, +/- inconclusive/uncertain impact, = no significant impact, - moderate negative impact, -- significant negative
impact.
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6.6.
Stakeholders’ views on impact of policy options
Policy option 1 would be acceptable to a majority of stakeholders and MS as the impacts/additional
costs and required changes would be minimal. There would be benefits of the extension of the
current VCU examination for agricultural plant species and vine to include characteristics that
contribute to sustainable production (VSCU). For the other crop groups currently not subject to
VCU (vegetables and fruit plants), the voluntary communication of the information coming from
the pre-registration trials (before application) could enable the farmers to choose the right varieties
according to their needs.
The majority of NCAs and stakeholders are of the opinion that the harmonisation of the framework
for OCs outside the scope of the OCR (option 1) would have the lowest impact on the increase in
cost and administrative burden. According to NGOs and certain academia the total exemption of
the activities of seed conservation networks, exchange in kind of seed between farmers and
marketing to amateur gardeners from the scope of the legislation would have the biggest positive
impact on the conservation and sustainable use of plant genetic resources. The seed sector and some
NCAs are concerned that a total exemption could be misused by farmers multiplying seed under a
service contract. As regards the possibility of using BMTs and digital solutions, some stakeholders
prefer that the use of BMTs and digital solutions remain optional because of a lack of resources to
invest in such technologies.
Stakeholders and NCAs are concerned about the increased costs and the reduced number of
varieties coming to the market under policy option 2 extending the VSCU examination to all crop
groups. NCAs state that the need for, and costs of, additional testing areas would be an important
limiting factor, highlighting that even official supervision may not be an adequate solution. Smaller
MS have reported that there would not be enough areas for field trials. MS have already identified
the lack of areas for field trials as a limiting factor for carrying out the VSCU under organic
conditions. Likewise, the seed sector is concerned that the VSCU examination under option 2
would lead to disproportionate costs especially for SMEs and to the decrease of new varieties
entering the market. While the main farmers’ association considers it important to assess new
varieties for those criteria and have the relevant information at hand, they are concerned about the
increased cost and the reduced availability of new varieties because of the compulsory VSCU
assessment
179
.
The majority of NCAs and stakeholders fear an increase in administrative burden upon the
inclusion of OCs into the scope of the OCR. Several NCAs and businesses are of the opinion that
option 2 including OCs into the scope of the OCR with simplified import controls would contribute
to more harmonised conditions for the operators and the marketing of PRM and FRM across MS.
NGOs are of the opinion that the introduction of lighter rules for the activities of seed conservation
networks, exchange in kind of seed between farmers and marketing to amateur gardeners would
hamper those activities and have a negative impact on the conservation and sustainable use of plant
genetic resources. According to the seed sector, the introduction of at least lighter rules for such
activities would offer a minimum guarantee for compliance with the plant health requirements and
for the traceability of such activities. Most NCAs and stakeholders including SMEs are of the
179
This position however reflects a compromise between their different members.
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opinion that the introduction of basic rules on innovative production processes, BMTs and digital
solutions would have a positive impact on the uptake and advancement of such technologies.
Most stakeholders and MS are of the opinion that harmonisation of the VSCU examination under
option 3 would be disproportionate and counterproductive. The majority of NCAs and stakeholders
fear an increase in administrative burden upon the inclusion of OCs into the scope of the OCR.
Only a few stakeholders are of the opinion that a full inclusion into the scope of the OCR with
stricter import controls at border control posts (option 3) would have the highest positive impact on
the creation of equal conditions for operators and marketed PRM and FRM across MS. NGOs and
certain academia strongly oppose to subjecting the activities of seed conservation networks,
exchange in kind of seed between farmers and marketing to amateur gardeners to the requirements
of the legislation. In their view, this would undermine all efforts undertaken for the conservation
and sustainable use of plant genetic resources. Most stakeholders and NCAs in favour of the use of
BMTs and digital solutions are of the opinion that the introduction of detailed rules would have a
negative impact on the use of such technologies and restrict scientific and technological
developments.
As regards FRM, the majority of NCAs and regional forest authorities who participated in the
targeted survey on FRM believe that the inclusion of the purposes for which the FRM is produced
will increase the administrative burdens for NCAs and operators, increase the costs for inspections
and require and additional investment by the operators. Respondents agreed that it is essential to
guarantee traceability of the genetic origin for the FRM users without increasing the administrative
burden and the costs.
7.
H
OW DO THE OPTIONS COMPARE
?
This section compares the expected impacts of the policy options in relation to the baseline scenario
in terms of their overall effectiveness, efficiency, coherence, subsidiarity and proportionality. It
considers the effects of no policy change in the long term.
Criteria
No policy
change
0
0
0
0
0
0
0
0
0
0
0
Policy
Option
1
+
+
+/-
+/-
+
+
+
+/-
++
+
+
Policy
Option
2
++
+
++
++
++
++
+
++
++
+
++
Policy
Option
3
+
+
+
+
+/-
++
+
+
+
+
+
Effectiveness: contribution to achieving the policy specific objectives (SO)
SO1: Simplified, clarified and harmonised basic rules
SO2: Enabling the uptake of new scientific and technical developments
SO3: Ensure availability of PRM/FRM suitable to address future challenges
SO4: Support the conservation and sustainable use of plant and forest genetic resources
SO5: Harmonisation of the framework for official controls
SO6: Coherence with PHL
Effectiveness: other economic, social and environmental impacts
Economic impacts
SMEs
Competitiveness
Innovation and research
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Criteria
No policy
change
Climate change resilience
Sustainable use of resources
0
0
0
0
0
0
0
0
Policy
Option
1
+/-
+/-
+/-
+
++
+
+
+
Policy
Option
2
++
++
++
+
+/++
++
+
++
Policy
Option
3
+
+
+
=
+/-
+
+
-
Environmental impacts
Social impacts
Food security
Employment
Efficiency
Coherence
Subsidiarity
Proportionality
Table 9: Global comparison of the options. The scale of the score given to impacts and assessment of efficiency, coherence, subsidiarity and
proportionality is based on the following scheme: ++ positive, + moderately positive, +/- inconclusive/uncertain, = not significant, - moderate
negative, --significantly negative.
7.1.
Effectiveness
The evaluation of effectiveness looks at the extent to which the option would achieve the
objectives. Option 2 overall outranks the other policy options. Option 3 ranks second, slightly better
than option 1, which however performs better than the no policy change scenario.
The common measures for
simplification
of administrative procedures are expected to accelerate
market access of PRM/FRM produced within the EU and of imported PRM/FRM.
For
innovative production processes, BMTs and the use of digital solutions,
options were
assessed in relation to the initial investment and the gradual reduction of costs for NCAs and
operators. Option 2 performed the best on these criteria while options 1 and 3 performed equally
well. Laying down a reliable framework under option 2 will create legal certainty and encourage
operators and NCAs to invest in these technologies and the
long-term benefits
would anyway
outweigh the initial investments. With option 1 (implementation by guidelines) there is a risk that
the rules will be fragmented and that operators may not be inclined to invest in such technologies
due to the absence of a reliable framework that will give them a perspective of a return on their
initial investment. More consistent rules on innovative production processes, BMTs and digital
solutions under option 3 come at the expense of the frequency for updating those rules due the rapid
pace of new technical and scientific developments.
To
ensure availability of PRM suitable for future challenges,
options were assessed in relation
to the scope of the sustainability assessment of new varieties and the level of harmonisation of that
assessment. The enlarged scope of the sustainability assessment under options 2 and 3 addresses the
objective of PRM contributing to more sustainable agri-food production and increased resilience to
climate change conditions in the most comprehensive way. With the voluntary extension of the
scope of the sustainability assessment (option 1) the increase in varieties with improved
sustainability characteristics of non-regulated crop groups may be lower. An approach balancing
harmonisation of the sustainability assessment with flexibility (option 2) allows for adaptation to
local agro-ecological conditions. For example, the relevance of pests and climatic conditions (e.g.
drought, frost) differs per region. Such adaptation would not be possible under a harmonised
sustainability assessment (option 3). The risk of option 1 (most flexible approach for sustainability
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assessment) is that MS will diverge in relation to the approach for this sustainability assessment and
that varieties without improved sustainability characteristics will reach the market.
Common measures creating a legal framework to
ensure the availability of PRM suitable for the
needs of organic agriculture
will ensure a consistent approach for variety registration and
certification of ‘organic varieties suitable for organic production’ and contribute to the target of
having 25% of agricultural production under organic conditions (F2F).
To
ensure availability of FRM suitable for future challenges,
options were assessed in relation
to the sustainability assessment of basic material, inclusion of non-forestry purposes into the scope
of the legislation and contingency planning. The enlarged scope of the sustainability assessment
under options 2 and 3 addresses the objective of FRM contributing to more sustainable forest
management and restoration of healthy forest ecosystems and increased resilience to climate change
conditions in the most comprehensive way. It cannot be guaranteed that the voluntary guidelines on
the assessment of sustainability characteristics under option 1 will be taken up to the same degree
as mandatory principles under options 2 and 3. Under option 1, there is the possibility that
improperly assessed FRM would reach the market and this could have a significant negative
environmental impact in the long term (e.g. forests susceptible to pests or other environmental
pressures). An approach balancing harmonisation of the sustainability assessment with flexibility
(option 2) allows MS to adapt to environmental and climatic conditions which may show quite
substantial regional differences. Option 3 would not allow such adaptation. The inclusion of
specific non-forestry purposes in the scope of the legislation (options 2 and 3) will avoid long-run
negative impacts on the resilience of forests and perform better than keeping the current scope
(option 1). In addressing temporary difficulties in supply of suitable FRM through contingency
planning, option 2 is expected to be the most effective. Under option 2 the requirement to establish
national contingency plans is coupled with the flexibility for MS to adapt contingency plans to their
environmental and climatic conditions. The voluntary approach under option 1 risks that MS will
ignore the need for such plans, while the highly harmonised approach under option 3 can prove
counterproductive as needs and priorities can differ significantly across the EU. A common
measure providing more and better information by nurseries to FRM users/buyers on the suitability
of FRM for current and future climatic conditions will allow FRM users/buyers to buy the right tree
for the right place and thus support the resilience of future forests. Overall option 2 would be more
effective in securing the availability of FRM suitable for future challenges.
To support the
conservation and sustainable use of plant genetic resources,
options were
assessed in relation to the approach towards seed conservation networks, exchange in kind of seed,
and marketing exclusively to amateur gardeners. A total exemption of these activities from the
scope of the legislation (option 1) will not fully meet the objective due to a lack of identification
and traceability of the PRM concerned. The procedures in option 3 (general requirements of the
legislation for variety registration and PRM certification) would be too cumbersome and
counterproductive towards meeting the objective. Option 2 offers the best solution for safeguarding
genetic diversity as it introduces lighter rules ensuring the identification and traceability of the
PRM concerned. To support the
conservation and sustainable use of forest genetic resources,
dedicated measures under options 2 and 3 would be most effective in comparison to the adoption of
guidelines that risk not to be followed by the MS (option 1). Overall, in supporting the conservation
and sustainable use of plant and forest genetic resources, option 2 would be most effective,
followed by option 1. Option 3 would have uncertain results as the highest harmonisation foreseen
under option 3 would be effective for securing the quality of the PRM/FRM concerned but not
suitable for its specific needs due to its higher genetic diversity.
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For the
harmonisation of the framework for OCs,
common measures on OCs across MS and
minimum requirements as regards the frequency and scope of OCs will provide a clear regulatory
framework and contribute to a level playing field for operators. Options 2 and 3 perform equally
well and better than option 1. Alignment of the OC rules outside the scope of the OCR (option 1)
would have the drawback of not making use of the advantages of the OCR (existing IT applications
and training). Options 2 and 3 will make use of the existing IT applications for OCs such as the
Information Management System for Official Controls (IMSOC). Moreover, it will be possible to
report suspected cases of PRM/FRM fraud through a secure IT portal. Training activities will be
organised to train MS official inspectors. As under option 1 the PRM/FRM legislation is outside the
scope of the OCR as regards risk-based OCs, it will not be possible for MS to use the
aforementioned IT applications and follow training courses.
Common measures for
coherence between the PRM/FRM legislation and the PHL
will create
clarity for NCAs and operators as regards the legal framework for OCs on PHL through the
removal of the duplication of RNQP requirements in both legal frameworks and the regulation of
all plant pests (QPs and RNQPs) only under the PHL.
7.2.
Efficiency
The evaluation of efficiency considers the extent to which the options result in costs and benefits
for NCAs, operators and other stakeholders (in the case of this initiative the users of PRM and
FRM). The net benefit as well as the Benefit Cost Ratio of each option have been calculated
(detailed presentation in Annex 4). Due to high uncertainty, calculations have been done for an
optimistic scenario (under which the highest benefits and the lowest costs are realised) and for a
conservative scenario (under which the lowest benefits and the highest costs are realised).
Global costs and benefits per option (excluding common measures)
Option 1
PRM/FRM
users
Costs per stakeholder
category (million
EUR/year)
Global costs (million
EUR/year)
Benefits per
stakeholder category
(million EUR/year)
Global benefits
(million EUR/year)
from 310 to
1 243
133
Operators
2
NCAs
0
PRM/FRM
users
400
Option 2
Operators
6
NCAs
from 43 to
98
PRM/FRM
users
667
Option 3
Operators
8
NCAs
from 58
to 113
135
0
0
from 621
2 486
from 449 to 504
to
0
0
from 733 to 788
from 466 to
1 864
0
0
from 310 to 1 243
from 621 to 2 486
from 466 to 1 864
Cost benefit analysis of options under an optimistic scenario (highest benefits and lowest costs)
Net benefit (million
EUR/year)
Benefit Cost Ratio
1 243 – 135 = 1 108
2 486 – 449 = 2 037
1 864 - 733= 1 131
1 243 / 135 = 9.20
2 486 / 449 = 5.53
1 864 / 733 = 2.54
Cost benefit analysis of options under a conservative scenario (lowest benefits and highest costs)
Net benefit (million
EUR / year)
Benefit Cost Ratio
310 – 135 = 175
310 / 135 = 2.29
621 – 504 = 117
621 / 504 = 1.23
466 - 788 =
- 322
466 / 788 = 0.59
Table 10: Net benefit and Benefit Cost Ratio of the options
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In terms of net benefits, under the optimistic scenario option 2 ranks first, followed by option 3 that
only marginally outranks option 1. Under the conservative scenario option 1 ranks first, followed
by option 2, while option 3 presents higher costs than benefits. In terms of Benefit Cost Ratio,
under both scenarios option 1 ranks better than option 2, while option 3 is always the worst option.
These calculations cannot capture a number of non-monetised benefits described in section 6. For
these, option 2 is performing better than options 1 and 3, especially as regards long-term
environmental and sustainability benefits (see an overview in Table 8). As a result, the comparison
of the options in terms of net benefit and benefit cost ratio is distorted in favour of option 1 against
option 2.
7.3.
Coherence
The initiative relates to several EU policy objectives, policy initiatives and instruments. The
evaluation of coherence looks at how consistent each option is with these and identifies the extent
to which they promote horizontal objectives and facilitate delivery of relevant key targets.
EU initiatives /
regulatory
framework
PHL
Key considerations
Under all options (same measure) coherence with PHL is maximised. All
requirements for PRM/FRM as regards plant health will be moved to PHL.
The PRM/FRM certification rules will require compliance with PHL.
Option 1 does not introduce any links between the PRM/FRM legislation and
the OCR. Options 2 and 3 harmonise OCs for PRM/FRM under the OCR
thus allowing alignment with OCs for other legislative frameworks under the
OCR (PHL, Organic Regulation and GMOs).
The DUS protocols used for granting CPVR (intellectual protection) are
applied also for the purposes of variety registration (authorisation for
marketing). While the two systems are independent, that is a variety can be
registered regardless of CPVR protection, the use of common DUS protocols
results in significant efficiency gains. Measures to facilitate organic
production and to support the conservation and sustainable use of plant
genetic resources will result in varieties (conservation, new locally adapted
and organic varieties) and heterogeneous material becoming available to the
market without meeting the DUS requirements, therefore also not eligible for
CPVR. However, this trade-off is considered necessary to achieve the
respective objectives for organic production and plant genetic resources.
The variety registration system of the PRM legislation (including the
assessment for characteristics contributing to sustainable production) applies
to all varieties irrespective of the breeding technique. The same applies for
acceptance of basic material under the FRM legislation. Varieties and FRM
with NGT traits will be treated in the same way as all other varieties
independently of the breeding methodology (conventional breeding, GM
technology, NGT technology). This initiative and the NGT initiative in
63
OCR
CPVR system
NGTs
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2733822_0065.png
preparation contribute to the goals of the EFD and F2F.
F2F
The increased efficiency and efficacy of the variety registration and
certification systems will support innovation in plant breeding and thus seed
and food security. The envisaged measures for organic production,
conservation varieties, new locally adapted varieties and heterogeneous
material will increase coherence with F2F as regards the genetic diversity of
PRM/FRM. Option 2 would be most coherent with the sustainability targets
of F2F through a sustainability assessment covering all crop groups
(improved varieties can help reduce use of fertilisers and pesticides) with an
implementation adjusted to the agro-ecological conditions of the MS.
In comparison to option 1, options 2 and 3 present increased coherence with
the SUR targets on reduced pesticide use through the extension of the current
VCU requirements for agricultural species and the introduction of
sustainability characteristics for the other crop groups which include
examination for resistance to plant pests. New varieties with increased
resistance to plant pests may require less pesticides. As option 2 is
considered more effective in this aspect than option 3, coherence with SUR
would be highest under option 2.
The PRM/FRM initiative includes specific sustainability considerations (‘lex
specialis’),
while respecting the general sustainability principles and
objectives of FSFS (‘lex
generalis’).
Measures supporting the conservation and sustainable use of plant and forest
genetic resources contribute to the Biodiversity Strategy objective to reverse
the decline of genetic diversity. Highest coherence is achieved under option
2, whereby lighter rules will enable the characterisation and documentation
of plant and forest genetic resources (in contrast to the absence of any
traceability under option 1) and provide more flexibility to operators (in
contrast to being subject to the general rules on variety registration and
certification under option 3).
Option 2 offers more coherence with the EU Forest Strategy target of
ensuring resilient and multifunctional forest ecosystems as it will be most
effective in enabling availability of climate-adapted FRM, by the inclusion in
the scope of the legislation of non-forestry purposes such as biodiversity
conservation and the requirement for national contingency plans.
The initiative will facilitate the broadening of the supply of suitable high-
quality PRM/FRM to support adaptation in agriculture and forestry through
the requirements for more information to end users of FRM on the suitability
of FRM for future climatic and ecological conditions; the establishment of
national contingency plans and strengthened sustainability requirements for
FRM; a strengthened assessment of new plant varieties (including as regards
abiotic factors such as drought); enabling the registration of locally adapted
varieties. Highest coherence is achieved under option 2 that provides for
flexibility to MS for implementation according to their agro-ecological and
environmental conditions).
All options improve coherence with the general requirement for digital
64
The initiative for a
new regulation on
the sustainable use
of plant protection
products (SUR)
FSFS
Biodiversity
Strategy
EU Forest Strategy
Climate adaptation
Digital Strategy
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2733822_0066.png
transformation by enabling digitalisation to improve the efficiency, integrity
and traceability of the certification and labelling system. Options 2 and 3
support digitalisation of OCs through IMSOC and on-line applications for
notifying non-compliances and combatting fraud.
SDGs
By strengthened sustainability requirements for all crop groups, measures for
organic production, plant and forest genetic resources, FRM national
contingency plans the initiative contributes to SDG 2 on zero hunger, SDG
12 as regards responsible production, SDG 13 on climate action and SDG 15
on life on land. As described above, the most coherent approach is provided
by option 2.
7.4.
Subsidiarity and proportionality
Table 11. Key considerations on coherence
All three options are consistent with the EU’s right to act under the Treaty of the Functioning of the
EU (agricultural production, the single market and the free movement of products within the EU).
In line with the principle of
subsidiarity,
the initiative is limited to aspects that can be better
achieved at Union level than if they were addressed individually by MS. Without common rules for
PRM (variety registration and certification), FRM (approval of basic material and certification) and
OCs, there would be 27 different systems instead of one common system in place. This situation
would result in obstacles to the movement of PRM/FRM in the internal market and increased costs
for controls to ensure equivalence between the different systems. A common EU framework is also
most appropriate in order to implement in a harmonised way the various international standards in
relation to PRM/FRM quality and plant health
180
.
In line with the principle of
proportionality,
the envisaged measures do not exceed what is
necessary for achieving the set objectives. A number of existing administrative procedures and
requirements will be simplified. The options reflect a trade-off between flexibility and
harmonisation. Their comparison shows that a fully harmonised system (option 3) does not perform
better and that the most proportionate solution is to retain some flexibility for MS (option 2). The
latter balances the need for harmonised rules for variety registration and PRM certification with the
flexibility for MS to implement those rules to adapt to their local agro-ecological conditions and
measures to strengthen sustainability (F2F) and respond to the call for adaptation to climate change
(EU Strategy on Adaptation to Climate Change) and restoring biodiversity (Biodiversity Strategy).
Likewise, in the FRM sector option 2 creates a balance between the general principles of
registration and FRM certification with flexibility for MS to respond to the biodiversity and climate
challenges. To achieve these needs and take account of the important differences between the PRM
and FRM sectors, the current 11 basic Directives
181
will be replaced by a Regulation on PRM and a
Regulation on FRM.
180
OECD, International Seed Testing Association (ISTA), United Nations Economic Commission for Europe
(UNECE), International Plant Protection Convention (IPPC), World Trade Organization/Sanitary and phytosanitary
measures (WTO/SPS).
181
Council Directive 98/56/EC on the marketing of propagating material of ornamental plants will remain in place.
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8.
P
REFERRED OPTION
The assessment indicates that policy option 2 is the strongest option to effectively address all the
objectives of the revision of the PRM and FRM legislation in an efficient and consistent manner.
Option 1 presents the best Benefit Cost Ratio as it presents the lowest costs, but it is not the most
effective option in terms of achieving the objectives. Actually, option 1 presents the risk that it will
lead in the long term to increased losses due to its reduced ambition in addressing comprehensively
the sustainability and climate adaptation challenges.
Stakeholder consultations showed that preferences were split between option 1 (most flexible
system but also with lowest costs) and option 2 (balancing harmonisation with flexibility). A
majority of stakeholders highlighted the need for some degree of flexibility for MS to adapt to their
local agro-ecological (PRM) and climatic and ecological conditions (FRM). All stakeholders were
in favour of a separate legal framework for FRM.
There are different stakeholders in the sector. Most stakeholders produce PRM and FRM for
commercial purposes while a segment does so for non-profit purposes. Although these stakeholders
have different activities and objectives, they all recognise the need to preserve and increase the
genetic diversity of PRM and FRM. In fact, the work done by seed conservation networks as
regards the conservation of plant genetic resources is invaluable as it gives the seed industry a
wider choice of PRM from which they can develop new varieties. Currently, the activities of actors
involved in conservation and sustainable use of plant and forest genetic resources, such as activities
of seed conservation networks and exchange in kind of seed are restricted. A future regulatory
framework needs to respond to the needs of the different stakeholders. The impact assessment
investigated what would be the best approach to do so. NCAs and the seed industry value the well-
functioning certification system and its importance at global level with the EU in the top three of
globally exporting regions. However, they recognise that the current system has its flaws, in
particular as regards the non-level playing field for operators, marketed PRM and FRM, OCs and
enforcement. Concerned operators and NGOs have highlighted that the existing derogations for
conservation varieties have not been successful. The organic sector has expressed the need for
adapted rules for organic varieties intended for organic production. Moreover, the existing system
is currently quite restrictive as regards the activities that can be carried out by operators under the
official supervision of the authorities. Since 2013, scientific and technical developments have
swiftly moved forward while the legislation does not have adequate provisions on innovative
production processes, BMTs and digitalisation.
The current legislation does not have sufficient means to respond to
sustainability and climate-
related challenges
addressed by the EGD and its strategies. For agricultural species sustainability
characteristics have been incorporated by certain MS in the VCU examination while there are no
sustainability characteristics for the other crop groups. The current experience with agricultural
species shows that a voluntary approach towards extending the sustainability assessment to other
crop groups will not work. The preferred option will extend and strengthen
sustainability
requirements.
This will come with a cost for businesses in terms of increased breeding costs while
NCAs may need to increase their capacity in areas and staff. Mitigating measures can be taken such
as a transition period in the application of the new legislation, reduction of the adjustment cost by
permitting VSCU examination under official supervision and promote collaboration between MS
by creating shared testing networks and allowing delegation of activities to other MS. Therefore,
strengthened sustainability requirements applicable to all crop groups show the highest
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effectiveness in contributing to the increase in sustainable agri-food production under F2F and the
availability of climate-adapted and more resilient PRM.
The regulatory framework should leave room for flexibility for MS to adapt to their local agro-
ecological conditions. Furthermore, it should proportionally regulate activities related to
conservation and sustainable use of plant and forest genetic resources.
The choice of legal
instrument, 2 Regulations (PRM and FRM) replacing 11 Directives, will reduce divergent
implementation across MS caused by national transpositions.
Under option 2, the introduction of
lighter rules for registration
of conservation and locally
adapted varieties and for conservation activities will introduce a proportionate approach for a small
market segment. This will most likely have a positive impact on employment in rural areas, both on
small operators marketing these varieties and on the development of local value chains. The
preferred option will also result in increased genetic diversity and contribute to the objectives of the
Biodiversity Strategy. Likewise, the introduction of variety registration rules adjusted to the
principles of
organic production
will contribute to the target of having 25% of agricultural
production under organic conditions pursuant to the goals of F2F.
As regards FRM stakeholder consultations also showed a split between options 1 (most flexible
approach) and 2 (balancing flexibility with harmonisation). Stakeholders were very strong on
separating the FRM legislation from the PRM legislation. In fact, the inclusion of FRM in the PRM
proposal was one of the reasons for rejecting the PRM proposal. FRM stakeholders recognise the
challenges brought about by climate change. They are confronted with increasing forest damages
caused by insects, storms and drought. Furthermore, there is an increased demand for FRM for
plantations for biomass production and for responding to the target of planting 3 billion additional
trees by 2030. To respond to these challenges and the higher demand in FRM there is a need for a
legal framework that includes a
sustainability assessment
of basic material, increasing the
resilience of FRM by taking measures on the
conservation and sustainable use of forest genetic
resources
and responds to the increased demand for FRM by extending to scope of the legislation
to
non-forestry purposes.
The FRM proposal will contain updated rules for FRM and ensure that
more information about the
suitability of FRM for future climatic conditions
is provided by the
nurseries to FRM users/buyers. National contingency plans will prepare MS for difficulties in
supply of suitable FRM. Altogether these measures will result in the planting of high-quality FRM
in suitable areas and contribute to the creation of resilient forests and the restoration of forest
ecosystems. The impact assessment showed that option 2 combining flexibility with harmonisation
was the best approach to address the problems identified in the current legislation. Option 3 does
not allow taking into account the differences between MS as regards the type of forests and the
activities carried out.
In the PRM and FRM proposals, the measures on the
harmonisation of OCs,
the
coherence with
the PHL, innovative production processes, BMTs and digital solutions
serve to increase the
efficacy and efficiency of the procedures and reduce the administrative burden for MS and
businesses, overall contributing to the competitiveness of the PRM/FRM sectors.
8.1.
REFIT (simplification and improved efficiency)
The revision of the PRM and FRM legislation offers the opportunity of savings for businesses as
regards variety registration, certification and OCs. There will be lighter rules for the registration of
conservation and locally adapted varieties as well as for the activities of seed conservation
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networks, the possibility of VSCU examination under official supervision (PRM), extension of
certification activities possible under official supervision (PRM/FRM), increased efficiency of the
registration and certification system (innovative production processes, BMTs and digital solutions)
and more efficient OCs. The table below gives an overview of the main opportunities under the
preferred option. Some of these serve to mitigate the increased burden caused by the extension of
sustainability requirements in the PRM and FRM sectors.
REFIT cost savings – preferred option
Description
Qualitative
assessment
+/-
Comments
Replacing 11 Directives by 2
Regulations
Regulation is directly applicable and
creates more harmonised approach for
businesses.
Reduction in administrative and
compliance costs because there will be
no official variety examination and
certification requirements, and labelling
requirements will be simplified.
Savings in compliance costs because
variety registration will be adapted.
Simplified
registration
and
labelling
requirements
for
conservation varieties and new
locally adapted varieties
+
Adapted
variety
registration
requirements for organic varieties
+
Notification of heterogeneous
material/OHM (PRM)
+
Reduction in administrative and
compliance costs because marketing of
heterogeneous material will be subject
to notification and simple labelling
requirements.
Reduction in administrative and
compliance costs because basic material
will be notified without the need for an
official registration requiring an official
inspection.
Reduction in compliance costs. Possible
need for one-off investment in
equipment and official training of
inspectors by certification NCAs, but
rather limited for those operators that
already carry out certification activities
under official supervision.
The EU Plant Variety Portal will
facilitate administration of variety
registration and accelerate market
access of new varieties by up to 4
months.
Digital certification labels will decrease
administrative burden.
Exchanges between MS through digital
Notification of basic material for
the purposes of conservation and
sustainable use of forest genetic
resoures (FRM)
+
Extension
of
certification
activities that are possible under
official supervision
+
Digitalisation for more efficient
processes in NCAs and businesses
+
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systems will decrease administrative
burden.
Innovative production processes
and BMTs
+
Innovative production processes and
BMTs will speed up PRM/FRM
production.
BMTs will render variety registration,
PRM/FRM certification and OCs more
efficient.
Inclusion in the scope of the OCR
+
Harmonised OCs for operators across
MS.
Increased efficiency of OCs.
Use of common IT platforms for
notifying information about PRM/FRM
imports, reporting non-compliances and
combatting fraud.
Table 12: Refit cost savings – preferred option
8.2.
Simplification and burden reduction for businesses, supporting the one-in
one-out approach
The activities that imply significant administrative costs for businesses are the following:
Application for acceptance of new varieties (PRM);
Application for registration of basic material (FRM);
Certification of PRM;
Certification of FRM;
OCs.
For implementing the one-in-one-out requirement, for each of these activities all cost drivers were
mapped but the analysis showed that these would undergo only marginal changes. There are no
administrative costs for the citizens.
9.
H
OW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED
?
Indicators for the preferred option, in relation to the core objectives of the PRM/FRM revision, with
suggested data sources are presented in table below.
General
objectives
To ensure a
level
playing
field
for
operators across
the EU
Specific objectives
Measures of success
and monitoring indicators
Harmonise
the
framework for OCs
on PRM/FRM
Comparable level of OCs across MS
-
-
Number of controls in proportion to risk from analysis of multi-
annual national control plans (NCAs) and annual reporting on
the number and outcome of OCs (NCAs)
Number of controls in proportion to risk from harmonised
checking and reporting of PRM/FRM imports (IMSOC)
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General
objectives
Specific objectives
Measures of success
and monitoring indicators
-
To improve coherence
of
PRM/FRM
legislation with PHL
Findings of EU audits (Commission)
Implementation of RNQP rules under PHL
-
Number of reporting and checking of RNQP-related non-
compliances (IMSOC) and from findings of EU audits
To
support
innovation and
competitiveness
of the EU
Enable uptake of
innovative production
processes, BMTs and
digital solutions
Uptake of innovative production processes, BMTs and digital solutions
-
-
-
-
Number of new certification schemes for PRM produced by
innovative production processes
Number of BMTs accepted for registration and certification
Number of MS setting up a digital system
Number of FRM entries obtained through innovative production
processes (FOREMATIS)
Contribute
to
sustainability,
biodiversity and
climate-related
challenges
Ensure availability of
PRM/FRM suitable
(identity, quality and
health) for future
challenges
Availability of PRM/FRM
Rules on FRM contingency planning
-
-
-
-
-
-
Number of new varieties per crop group accepted following the
general rules on DUS and sustainability assessment (Common
Catalogues)
Number of FRM entries containing information on suitability of
FRM for climatic and ecological conditions (FOREMATIS)
Quantities of certified PRM/FRM (reporting by NCAs)
Number of MS requests to apply for derogations to address
temporary difficulties in supply of seed (Commission)
Number of national contingency plans to address FRM supply
difficulties (notification by NCAs at adoption)
Findings of EU audits (Commission)
Ensure availability of
PRM/FRM suitable to
address
future
challenges
Increased availability of PRM suitable for the needs of organic
agriculture
-
-
Number of accepted “organic varieties suitable for organic
production” (Common Catalogues)
Quantities of certified PRM of “organic varieties suitable for
organic production” marketed within the EU (NCAs)
Support
the
conservation
and
sustainable use of
plant
and
forest
genetic resources
Increased availability of PRM of conservation and locally adapted
varieties
Increased availability of FRM for purposes of conservation of forest
genetic resources
-
-
-
Number of conservation and new locally adapted varieties per
crop group (Common Catalogues)
Quantities of PRM of conservation and new locally adapted
varieties marketed (notifications by operators to NCAs and
reporting by NCAs)
Number of notifications of heterogeneous material (notifications
by operators to NCAs and reporting by NCAs)
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General
objectives
Specific objectives
Measures of success
and monitoring indicators
-
-
-
Quantities of marketed PRM of heterogeneous material
(notifications by operators to NCAs and reporting by NCAs)
Number of SCNs (notifications by operators to NCAs and
reporting by NCAs)
Number of FRM notifications for the purposes of forest genetic
resources’ conservation (FOREMATIS)
Table 13. Measures of success and monitoring indicators
The legislation will be considered successful if there are sufficient quantities PRM and FRM
available that are suitable to address future challenges and respond to the needs of the different
types of PRM and FRM users. The design of indicators that are Specific, Measurable, Achievable,
Realistic and anchored within a Time Frame (SMART) is not fully possible because the number
and types of varieties available in the Common Catalogues is demand driven. Farmers will plant
PRM of those varieties for which there is a demand. Moreover, there is no simple relationship
between the number of varieties and the quantities of certified PRM. For example, a few wheat
varieties could cover the demand for wheat if planted in a large agricultural area, while it would be
required to plant 100 varieties of tomatoes to cover diverse consumer demands.
The PRM and FRM legislation regulates the access to the market and the revision addresses the
identified bottlenecks. For example, current variety registration rules are too restrictive for organic
and conservation varieties. Rules that are adjusted to the characteristics of such varieties will be
introduced in order to enable their access to the market. Accordingly, success would mean that
within 10 years more organic and conservation varieties are registered and their seed/PRM is made
available in the market in sufficient quantities. It cannot be anticipated how many new varieties and
which quantities of PRM/seed will be marketed, as this depends on the uptake of the new
opportunities by the operators and the farmers presenting a sustained demand for such varieties.
Another example is that the current rules for examination of new varieties, PRM certification and
OCs do not provide for the use of new methods (BMTs) that have the potential to increase the
efficiency of these procedures. The revision will remove this obstacle. Success would mean that
within 10 years BMTs are widely used and lead to a reduction of costs of examination of new
varieties. The revision is expected to stimulate their development and use. Genetic markers are
specific to each species and variety. It cannot be anticipated if suitable markers will be available for
all.
The success of the legislation will therefore be measured through the number of varieties and basic
material which are successfully registered in the Common Catalogues and the quantities of certified
PRM and FRM produced thereof. The Common Catalogues (as of 2023 accessed through the new
EU Plant Variety Portal) will be a key source for the indicators for monitoring progress as regards
the type of plant varieties (accepted under general rules on DUS and sustainability assessment or
under rules for conservation/locally adapted varieties or organic varieties suitable for organic
production). Other sources will be notifications and reports from MS as well as audits by the
Commission.
Moreover, this approach has been chosen because it is difficult to assess the individual
contributions of the PRM and FRM legislation to sustainable agri-food production and restoration
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of forest ecosystems, respectively. The impact of using improved varieties will be a combination of
selecting the appropriate variety for the regional agro-ecological conditions and applying good
agricultural practices. It will also depend on the weather conditions. Likewise, in the FRM sector
the improvement is assessed through the indirect impact of using improved tree seeds on the per
unit area productivity of regenerated forests. Improved tree seeds may better survive in a harsh
climate or show better tolerance against damages through abiotic or biotic factors.
The number and quantities of PRM of conservation and locally adapted varieties, organic varieties
suitable for organic production, heterogeneous material and FRM notifications for the purposes of
forest genetic resources conservation will offer an indirect measure of contribution to increased
genetic diversity.
The EU Plant Variety Portal will allow MS to fulfil their reporting obligations through online
submission of the relevant data (in the long term, machine to machine). MS’ reporting obligations
under the OCR as well as EU audits will be important mechanisms to check the implementation of
the new PRM/FRM legislation in MS. As regards the coherence with the PHL, the use of already
existing IT applications for reporting RNQP non-compliances and the submission of PRM/FRM
import documents (IMSOC) will lead to efficiency gains.
The Commission will review the indicators periodically. The implementation of the national
contingency plans ensuring FRM supply will be regularly monitored and compared with the data
obtained from the Forest Information System for Europe
182
as regards the forest areas lost because
of extreme weather, forest fires and disasters.
The proposed reference period for the monitoring framework of the new PRM and FRM legislation
is 10 years as it takes 10-12 years to develop a new plant variety. Based on the time needed to
obtain meaningful data through annual monitoring, it is considered appropriate to supplement this
monitoring with a formal evaluation of the initiative at the earliest 10 years after the planned legal
proposal becomes applicable. It should be avoided that the evaluation takes place before the impact
of the new requirements for variety acceptance, lighter system for registration of conservation
varieties and new locally adapted varieties and the notification of heterogeneous material and basic
material for the purposes of forest genetic resources conservation becomes visible. The same holds
true for the other actions that need sufficient data and monitoring information on the
implementation, application and enforcement of the expected legal provisions.
182
Forest Information System for Europe
https://forest.eea.europa.eu/
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A
NNEX
1: P
ROCEDURAL INFORMATION
1.
L
EAD
DG, D
ECIDE
P
LANNING
/CWP
REFERENCES
The Directorate-General for Health and Food Safety (DG SANTE) is the lead DG on the initiative
on Revision of the plant and forest reproductive material legislation. This initiative is in the
European Commission's Work Programme for 2022, in Annex II: REFIT initiatives, under the
heading “A European Green Deal”. The initiative has received the validation in the Agenda
Planning on 25 September 2020 (reference PLAN/2020/7576) and the Inception Impact
Assessment was published on 15 June 2021.
2.
O
RGANISATION AND TIMING
An Inter-Service Steering Group (ISSG) was set up. The following Commission services were its
members: SG (Secretariat-General), SJ (Legal Service), AGRI (Directorate-General for Agriculture
and Rural Development), CLIMA (Directorate-General for Climate Action), ENV (Directorate-
General for Environment), JRC (Joint Research Centre) and TRADE (Directorate-General for
Trade). GROW (Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs)
and RTD (Directorate-General for Research and Innovation) were also invited but did not join the
ISSG. The ISSG met on the following dates:
Dates
17 June 2021
Topics discussed
Consultation strategy
Terms of reference of the study supporting the impact
assessment for the revision
State of play of the revision
Kick-off meeting with the contractor for the study
supporting the impact assessment for the revision
State of play of the revision
Draft policy options
Outcome of consultations
Draft interim report of the study supporting the impact
assessment for the revision
Final report of the study supporting the impact assessment
for the revision
Draft Commission impact assessment report
Finalisation of the Commission impact assessment report
Presentation of revisions following the RSB opinion
Presentation of the legal proposals
6 October 2021
19 May 2022
14 December 2022
12 January 2023
18 April 2023
Table 14. Meetings of the ISSG.
In addition to the above meetings, the members of the ISSG were regularly informed on the
progress of the initiative and consulted in written on the questionnaire of the open public
consultation and the draft final report of the study supporting the impact assessment for the
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revision. In addition, DG SANTE consulted the Community Plant Variety Office (CPVO) on
aspects of this initiative relevant to CPVO’s mandate.
3.
C
ONSULTATION OF THE
RSB
An upstream meeting with the Regulatory Scrutiny Board was held on 6 May 2022. A first version
of this Impact Assessment Report was submitted to the RSB on 18 January 2023, the meeting took
place on 15 February 2023 and the RSB written opinion was received on 17 February 2023. The
Board concluded that the DG had to revise the report in accordance with the Board’s findings
before launching the interservice consultation.
RSB main findings
The Board noted the additional information
provided and commitments to make changes to
the report.
However, the report still contained significant
shortcomings. The Board gave a positive
opinion with reservations because it expected
the DG to rectify the following aspects:
(1) The report did not present a comprehensive
analysis of costs and benefits. The analysis of
impact on competitiveness of EU operators,
including on SMEs, was not sufficiently
developed.
(1) A comprehensive analysis of costs and
benefits has been added in Section 8 of Annex 4.
Aspects related to SMEs and competitiveness
have been further detailed across Section 6 of
the IA report and they are also summarised in
the new Sections 6.1.6 and 6.1.7.
Modification of the IA report
The recommendations of the Board have been
implemented.
(2) The comparison of the options in terms
efficiency was flawed.
RSB adjustment requests
(1) The report should explain how the concerns
raised by the European Parliament in rejecting
the Commission’s ‘2013 PRM proposal’ have
been addressed by this initiative.
(2) The Section 7.2 on the comparison of the
options in terms of efficiency has been revised.
Modification of the IA report
(1) In Section 1 of the IA report Table 1 has
been added, giving an overview of the concerns
expressed by the European Parliament in 2014
and the measures addressing those concerns in
this initiative.
The description of the dynamic baseline should
be supplemented with quantitative assessment No additional information has been found to
where feasible.
allow adding further quantitative elements in the
description of the baseline. The relevance of
moving from south to north of agronomic and
forestry practices in order to compensate for
climate change is described in Section 5.1 of the
IA report.
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(2) The intervention logic should be more
clearly presented. The report should better link
the specific objectives with the identified
problems. The specific objectives should be
expressed in more SMART terms.
(2) In Section 4.3 of the IA report the
intervention logic has been added, linking the
identified problems, the general objectives,
specific objectives and the policy options. In
Section 9 of the IA report, the measures of
success and monitoring indicators have been
revised and certain limitations in applying the
SMART approach are explained.
(3) The Section 5.2 of the IA report has been
(3) Based on a clearer intervention logic, the redrafted in order to explain in more details the
report should explain in more detail how the design of the policy options. The previous
policy options were designed.
Annex 6 has been integrated in Section 5.2 of
the IA report, so that the main report presents in
more details the content of each option. In
Sections 5.1 and 5.2 the differences between the
baseline and Option 1 are further clarified.
(4) The report should assess the impact on the
EU operators, seed producers, foresters, and
farmers, including on their international
competitiveness. The report should elaborate on
Member States’ and other stakeholders’ groups
views on the impacts of the options under
consideration.
(4) More details have been added on these
aspects across Section 6. Aspects related to
SMEs and competitiveness from across Section
6 are also collated in the new Sections 6.1.6 and
6.1.7. The different views on the impacts of the
options under consideration are presented in the
new Section 6.6.
(5) A comprehensive analysis of costs and
benefits has been added in Section 8 of Annex 4.
The major costs and benefits elements of each
option are summarised in Section 6.5 of the IA
report. The net benefit as well as the Benefit
Cost Ratio of each option is presented in Section
7.2 of the IA report. Further details on
underlying assumptions and uncertainties have
been added in Annex 4.
(5) The report should present a clear and
comprehensive overview of the costs and
benefits of each of the three options. It should
present the net benefit of each option, as well as
the Benefit Cost Ratio.
(6) The scores of the baseline have been set to
(6) Throughout the report and in all comparison zero throughout the report.
tables the scores of the baseline should be set at
zero.
(7) The report should systematically refer to the (7) Further details on the views of different
views of different stakeholder categories, stakeholder categories have been added
including diverging views, throughout the throughout the report. Sections 5.2.5 and 6.6
have been added, elaborating respectively on the
report.
views on policy options and on views on
impacts of the options, including diverging
views on these.
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Table 15. Modifications of the IA report following the comments by the RSB.
4.
E
VIDENCE
,
SOURCES AND QUALITY
The current PRM and FRM legislation comprises 1 Directive on the Common Catalogue and 11
marketing Directives and covers diverse crop groups from annual crops in the case of agricultural
species to perennial crops in the case of fruit trees. Each crop group has its specificities in relation
to the two pillars variety registration (DUS examination) and PRM/FRM certification. The
consultation activities have focussed on gathering quantitative and qualitative data in relation to
those two pillars and on OCs. It must be highlighted that most of the available information concerns
agricultural species as this is the most important market segment. A lot of effort was put in the
collection of information on the activities of seed conservation networks, exchange in kind of seed
between farmers and the reasons for the limited implementation of the Directives on conservation
varieties and landraces. In general, it is to be noted that because of the diversity of crop groups and
the multitude of technical aspects and some marginal activities, it was not feasible to assess each
aspect of the envisaged amendment of the legislation in detail.
Evidence for this Impact Assessment has been collected by two external studies and a number of
other sources.
A first study
183
aimed to update the state of play since the last evaluation of the PRM/FRM
legislation in 2008
184
and the 2013 impact assessment
185
, as well as to fill key knowledge gaps, in
order to support the Commission to prepare the study on the Union’s options to update the existing
legislation on the production and marketing of PRM
186
following a request by the Council
187
.
Evidence was collected by literature review, 40 interviews (with academics, civil society
organisations, public authorities, industry representatives and farmers’ organisations), a workshop
with 6 FRM experts, and four targeted surveys. The targeted surveys were addressed to 1) NCAs
(authorities from 25 MS responded), 2) amateur gardeners (with 6089 participants from 29
countries), 3) maintainers of registered varieties for the amateur market (81 participants) and 4)
FRM stakeholders (80 participants, including both FRM users and NCAs). The limited publicly
available information and the fact that it is rarely broken down per group of agricultural species (i.e.
cereal seed, beet seed, etc.), the small sample size and self-selection bias (interviews and targeted
surveys) were identified by the contractor as limitations to the quality of the evidence collected by
this study.
A second study
188
aimed to support the Commission in the preparation of this impact assessment.
This study collected evidence by literature review, a targeted survey addressing NCAs, operators
and other stakeholders in the PRM and FRM sectors (99 respondents in total), 43 interviews (30 on
PRM and 13 on FRM), a focus group on the topic of marketing to amateur gardeners, a focus group
on FRM topics, a case study on exchange in kind of seed (based on literature review and
interviews) and an analysis of MS experiences on conservation varieties and varieties for amateurs
183
184
ICF (2021).
FCEC (2008).
185
SWD (2013) 162 final.
186
SWD (2021) 90 final.
187
Council Decision (EU) 2019/1905 of 8 November 2019. OJ L 293, 14.11.2019, p. 105-106.
188
ICF (2023).
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of fruit plants and vine (based on a targeted survey to 17 NCAs). The low response rates to
questions aiming to collect quantitative information to fill-in knowledge gaps as regards market
size and costs for NCAs and operators were identified by the contractor as limitations to the quality
of the evidence collected by this study.
Despite the aforementioned limitations, the data collected by these studies allows to make
assumptions (e.g. range of minimum to maximum values) and even allows for higher certainty on
certain aspects where the dataset is rather complete, as NCAs from most MS have responded to the
relevant questions. DG SANTE has used this data for in-house calculations additional to those
carried out by the external studies, as appropriate in combination with quantitative data extracted
from the Common Catalogues
189
on the numbers of registered varieties, Eurostat
190
and the farm
accountancy data network (FADN)
191
on the cost of PRM and its share of the total cost of inputs in
agricultural production, and the portal of the European Seed Certification Agencies Association
192
on production of certified seed (see Annex 4 for details). These sources offer the best available data
for the respective topics. DG SANTE also extracted evidence from published position papers of
stakeholder organisations (either published online or submitted in the context of the consultations),
online documents of NCAs, articles published in scientific journals and reports of EU co-financed
research projects. In particular information from official sites and articles in scientific journals
(having been subject to peer review) is considered to be evidence of higher quality. Remaining data
gaps have been addressed by using assumptions and calculations done in older studies
193
but in
such cases the uncertainty is higher. Finally, additional evidence on views and opinions of NCAs
and stakeholders were collected by extensive consultation activities undertaken by DG SANTE in
the form of online questionnaires and meetings with NCAs and stakeholders (see Annex 2 for
details).
189
https://food.ec.europa.eu/plants/plant-reproductive-material/plant-variety-catalogues-databases-information-
systems_en.
190
Economic accounts for agriculture:
https://ec.europa.eu/eurostat/web/agriculture/data/database.
191
https://agriculture.ec.europa.eu/data-and-analysis/farm-structures-and-economics/fadn_en.
192
http://escaa.org/.
193
FCEC (2008) and FCEC (2011).
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A
NNEX
2: S
TAKEHOLDER CONSULTATION
(S
YNOPSIS REPORT
)
1.
C
ONSULTATION STRATEGY
The objectives of the consultation activities were:
to ensure that all relevant stakeholders are identified and given the opportunity to participate
in the consultation;
to provide the opportunity for stakeholders to inform the impact assessment, in particular,
offering an opportunity for them to inform the development of policy options addressing the
problems identified;
to gather stakeholders’ opinions on the potential policy options together with data and
qualitative evidence concerning the relevant impacts of the policy options considered.
The consultation strategy combined different consultation methods in order to engage as much as
possible all stakeholders identified:
NCAs for variety registration, PRM certification (agriculture, horticulture, vine), FRM
certification, plant and forest genetic resources
The CPVO
Plant breeding companies, seed and PRM multipliers and suppliers, seed and plant trading
companies, nurseries, from the organic and non-organic sectors, both large and small
operators, and their associations
Professional farmers including organic farmers
Amateur gardeners
Foresters and forestry associations
Scientific networks on plant and forest genetic resources
Seed conservation networks.
1.1.
Consultation activities undertaken by DG SANTE
DG SANTE consulted stakeholders by means of the publication of the inception impact assessment
(IIA) for feedback, the open public consultation (OPC), targeted surveys, working groups with
NCAs and stakeholders and bilateral meetings with stakeholder organisations.
The IIA was open for feedback between 15 June and 13 July 2021 on the ‘Have your say’ portal
194
and was addressed to any interested citizen or stakeholder. Feedback was provided in a free text
format, while respondents also had the possibility to submit position papers. The feedback collected
was taken into account for adjusting the problem description and options, the design of further
consultation activities, as well as for this impact assessment.
194
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13083-Plant-and-forest-reproductive-
material-revised-rules-_en
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The OPC was carried out between 21 December 2021 and 27 March 2022 on the ‘Have your say’
portal
195
and was addressed to any interested citizen or stakeholder. It included two sets of closed
multiple choice questions, one for PRM and one for FRM. Respondents could also provide
additional information either by a short free text or by uploading a position paper. The feedback
collected was taken into account for this impact assessment.
DG SANTE also organised two targeted online consultations on EUSurvey
196
, one addressed to
NCAs responsible for FRM, held from 5 April to 30 May 2022 and one addressed to SMEs, held
from 2 May to 13 July 2022. The SME survey was anonymous. Furthermore, DG SANTE held
meetings of working groups (online due to Covid-19 restrictions) with the NCAs and with
stakeholders to discuss specific aspects of the revision. Summary reports of these meetings were
published on the webpages of DG SANTE
197
. At the request of a number of stakeholders, DG
SANTE held bilateral meetings with them and also attended relevant events of stakeholders.
Finally, some stakeholders and NCAs submitted to DG SANTE opinions on specific matters
outside the framework of the IIA and the OPC. All relevant information was taken into account for
this impact assessment.
1.2.
Consultation activities conducted in the framework of the study supporting
the impact assessment
In the framework of the study a targeted survey, interviews and two focus groups were carried out.
The targeted survey was held online between 9 March and 1 April 2022. It was open to NCAs,
operators and other stakeholders in the PRM and FRM sectors, but those interested to participate
had to pre-register. The interviews aimed to obtain more detailed and contextualised views. The
first focus group addressed the topic of marketing to amateur gardeners and the second one the
definitions of “forestry” and “non-forestry” purposes in relation to the scope of the FRM legislation
and the potential measures to address temporary difficulties in supply of FRM.
2.
S
TAKEHOLDER PARTICIPATION
The feedback to IIA received 66 responses from 16 countries (15 MS and a third country).
Geographic distribution was uneven, as 47 responses came from 5 MS (5 to 15 responses by each
of them) and 18 responses from 10 MS (1 to 4 responses per MS). As regards type of stakeholder,
the submissions were from business associations (20), NGOs (13), companies/businesses (10),
public authorities (5), EU citizens (4), academic/research institutions (3), trade unions (3) and other
(8). The over-representation of one MS (15 respondents from Belgium) is explained by the fact that
these respondents are EU-wide associations or NGOs based in Brussels. With the exception of
public authorities, the most relevant types of activities, plant breeders (conventional and organic),
marketing of PRM, nurseries (FRM, ornamental), seed conservation networks and farmers, are
represented in a balanced way.
195
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13083-Revision-of-the-plant-and-forest-
reproductive-material-legislation/public-consultation_en
196
https://ec.europa.eu/eusurvey/home/welcome
197
https://food.ec.europa.eu/plants/plant-reproductive-material/expert-groups-and-working-groups-legislation-plant-
reproductive-material_en
and
https://food.ec.europa.eu/horizontal-topics/expert-groups/advisory-groups-action-
platforms/advisory-group-fcaph/wg-2022_en
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The OPC received 2449 responses from 29 countries (24 MS and 5 third countries). Number of
responses ranged from 1 to 1684 per MS when citizens are included and from 1 to 184 per MS
when citizens are not included. There were no responses from Lithuania, Malta and Romania. All
relevant types of activities as well as public authorities are represented in a balanced way.
Furthermore, there were in total 15 responses from third countries. The majority of responses (78%,
1908 of 2449) were from EU Citizens. Of the 541 respondents who were not citizens, 37% (202 of
541) were from company/business organisations. By size, a majority of company/business
organisations (59%, 120 of 202) were from ‘Micro (1 to 9 employees)’ enterprises. Over half of all
public authority responses (54%, 29 of 54) were from national authorities. Amongst Public
authorities, Germany had the highest number of responses (18 of 54), with responses from national,
regional and local authorities. The first question of the OPC was targeted at the general public and
was responded to by the whole sample. Subsequent questions were addressed to stakeholders with
expert knowledge of the legislation and only 10% of citizen participants respond to these. In total,
488 participants responded only to expert questions on PRM, 61 only to expert questions on FRM,
and 210 to expert questions on both PRM and FRM. Over three quarters (79%) of citizen
respondents, and half (50%) of company/business organisation respondents were from Sweden.
National press articles concerning the PRM legislation revision and public consultation may have
stimulated the higher-than-average level of response from Sweden. However, these have not been
identified as a campaign as there was a high level of variation in the replies to closed question
responses. For Swedish citizens, only a small number of open question responses are identical (less
than five in any one case) but they have a high tendency to focus on a few specific issues, in
particular asking to facilitate the preservation of local and traditional varieties and not to impose
any rules on the exchange of seed between hobby growers. In both categories “company/business
organisations” and “public authorities” there were cases of submissions of identical additional
documents, although less than 10 in each case. A campaign has been identified where 32
respondents, mostly citizens from Germany, submitted identical additional documents supporting
that DUS criteria should not be a prerequisite for variety registration, calling for extended
exemptions for conservation purposes and for the implementation of the farmers’ rights defined in
the International Treaty on Plant Genetic Resources for Food and Agriculture and the United
Nations Declaration on the Rights of Peasants. As regards FRM 12 German stakeholders composed
of regional authorities, citizens and a business association stated that; the legislation should not be
substantially changed, an extension of the number of EU-regulated species is necessary, forestry
and non-forestry purposes should be clearly defined, the origin of the FRM must be guaranteed in
order for forests derived from that FRM to fulfil the various forest functions for the next decades
and centuries, a stable and sustainable funding to minimise potential supply shortages should be
prioritised through an EU regulation and that the financial impact on all forest stakeholders affected
by the implementation of the legislation must be restricted to a minimum. There were 25 responses
to the targeted survey addressed to NCAs responsible for FRM from 19 different MS. There were
251 responses to the targeted survey addressed to SMEs from 22 different MS (from 1 to 33
responses per MS).
The targeted survey conducted in the framework of the external study supporting the impact
assessment received 99 responses from 27 countries (23 MS and 4 third countries). 8 respondents
identified themselves as academic/research institute, 26 as business association, 21 as
company/business, 4 as NGO, 31 as a public or NCA and 8 as “other”. There were no responses
from Latvia, Lithuania, Malta and Romania. 74 respondents contributed only in relation to PRM, 18
only in relation to FRM and 7 in relation to both PRM and FRM aspects. Distribution as regards
origin and type of activities is considered satisfactory.
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3.
R
ESULTS OF STAKEHOLDER CONSULTATION ACTIVITIES
As regards PRM, there is overall support for maintaining the
current regulatory system
and its
two basic pillars of variety registration (based on DUS and where applicable VCU) and PRM
certification. Some respondents called for maintaining the current “one-key one-door” approach
(i.e. same DUS rules for the plant variety rights regime and the market access of varieties) while
most NGOs called to maintain DUS only for plant variety rights, allowing the breeder to choose
whether to use DUS or not for variety registration. Potato breeders in particular called for the
abolishment of VCU for potato varieties and vegetable breeders called not to introduce VCU for
vegetable varieties. The various actors involved in conservation activities, small-scale farmers
interested in exchange in kind, the organic sector and most citizens, also called for
derogations
from this basic system
in order to enable the availability of PRM belonging to varieties that cannot
meet the DUS requirements and/or to heterogeneous material. The necessity of such derogations is
agreed by all stakeholders for meeting objectives relevant to conservation and sustainable use of
plant genetic resources, organic production and production in marginal areas. There is however
important divergence of views in relation to the degree of such derogations, ranging from calls for a
total exception of
exchange in kind, conservation activities and marketing to amateur
gardeners
to the opinion that existing derogations are sufficient and do not need to be extended. In
particular, several NGOs called for the new legislation to explicitly implement farmers’ rights as
defined in the International Treaty on Plant Genetic Resources for Food and Agriculture and the
United Nations Declaration on the Rights of Peasants. Main arguments against total exemption are
the concerns about plant health i.e. spreading of diseases by PRM exempted from the legislation
(opinion shared by conventional breeders, farmers other than small-scale ones and NCAs), the
respect of plant variety rights and the avoidance of unequal competition (opinion mostly supported
by conventional breeders), as well as the need to guarantee a minimum quality and traceability
(opinion shared by farmers other than small-scale ones and most NCAs, also important for 50% of
the citizens responded to the various consultations). As regards
marketing to amateur gardeners,
several stakeholders were of the view that it is not possible to separate marketing to professional
users from marketing to amateur gardeners. Many operators market PRM to both professional users
and amateur gardeners whereas others market exclusively to amateur gardeners. As regards
organic
varieties,
organic breeders stressed the need for variety examination (DUS and VCU where
applicable) adjusted to the needs and the principles of organic production. In contrast, conventional
breeders questioned the need for such derogations for organic varieties, as currently in their view
DUS varieties multiplied under organic conditions cover most of the needs of the organic sector
with very good results.
In relation to
sustainability,
there is overall recognition of the importance of PRM as the starting
point of agri-food production for achieving the relevant objectives. Conventional breeders and most
NCAs supported that the current VCU requirements for agricultural plant species already contribute
to these objectives, as they allow for the acceptance of varieties with characteristics that contribute
to a more sustainable production as disease resistance, nutrient efficiency, drought tolerance and
increased yield. Introduction of requirements of examination of new varieties of fruit plants and
vegetables for such characteristics was supported, though not in the form of the current VCU for
agricultural plant species, as the uses especially for vegetables are very diverse. The need for
flexibility to address the different conditions across Europe was stressed by almost all respondents.
Actors involved in conservation activities and organic production stressed that the contribution to
sustainability of material not meeting the DUS requirements is equally important, especially for
production under low-input and organic conditions and in relation to short supply chains (locally
adapted varieties for local markets). Some of these actors also put in question the usefulness of
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examination of varieties for specific characteristics, arguing that one should rather look into the
sustainability of agricultural production practices.
In relation to links to
plant health requirements,
the need to remove duplications on RNQPs
between PHL and PRM was recognised by most NCAs and operators. For the purposes of
conservation and sustainable use of genetic resources some stakeholders called for exempting
operators and PRM from all plant health requirements. On the contrary, the majority of NCAs and
other operators explicitly opposed to exemptions from plant health requirements, even if
exemptions would be granted from the PRM rules for variety registration and PRM certification.
As regards
OCs,
most operators agreed that a harmonisation of requirements is desirable, noting
that this however should not lead to increased administrative burdens for them. Views were also
split as regards the inclusion of the PRM and FRM legislation in the scope of the OCR, due to
concerns for potential increase in administrative burdens. In particular for PRM, almost all NCAs
and operators were against including the certification system as such under the OCR. The majority
saw benefits as regards more efficient marketing and import controls. As regards FRM, most
respondents opposed to the inclusion of the FRM legislation into the scope of the OCR because of
the specificity of OCs in this sector and called for OCs to remain under the control of the respective
forest competent authority. Most stakeholders of all categories called for maintaining some
flexibility in the organisation of OCs and keeping the costs as low as possible.
In relation to the use of
BMTs
and
digital solutions,
most PRM and FRM stakeholders agreed that
these could bring benefits and called for the legal framework to allow the latest technologies to be
applied, in line also with developments of international standards. There is overall agreement that
the phenotype-based system of registration of varieties should be maintained. Some stakeholders
even called to limit BMTs use only when these are linked to phenotypic expression. Almost all
however could agree to introduce the options for use of BMTs and digital solutions, without
making these an obligation.
There is overall support for extending PRM certification activities under
official supervision.
Above 50% of FRM stakeholders were favourable of allowing certain certification tasks to be
conducted under official supervision except for the issuing of the master certificate. Some PRM and
FRM stakeholders declared that SMEs might not have sufficient human and financial resources for
carrying out certification under official supervision. They stressed that it should always be possible
for the operators to opt for certification by the NCAs. However, views on whether VCU should
become possible under official examination were split, as fears were expressed by different
stakeholders that the reliability of results would be undermined and/or that it could be difficult to
have comparable results. The majority of forest NCAs and regional authorities opposed to the
assessment for the approval of basic material intended to produce FRM of the source-identified and
tested categories by operators under the official supervision of the NCAs.
All respondents that provided comments in relation to
ornamental propagating material
emphasised that there is no need to change the current simple rules. There should not be any DUS
tests for variety registration of ornamental crops as such tests would seriously increase costs and
decrease the number of varieties on the market without having any benefits. In their opinion, the
market regulates itself with a private registration system for determining the identity of varieties.
As regards
FRM,
there is overall support for keeping the FRM legislation separated from the
legislation on other PRM. All respondents called for keeping the existing pillars of registration of
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basic material and FRM certification. The majority of respondents highlighted the necessity to
retain flexibility allowing MS to decide which FRM is adapted to the local and regional climatic
and ecological conditions. Respondents expressed mixed views on the extension of the scope of the
FRM legislation to the production and marketing of FRM for certain non-forestry purposes.
4.
C
ONCLUSIONS
The different consultation activities complemented each other to achieve a balanced evidence base
covering different stakeholder categories. From all the stakeholder consultation activities organised,
it emerges that option 2 would best address the concerns of all actors.
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A
NNEX
3: W
HO IS AFFECTED AND HOW
?
1.
P
RACTICAL IMPLICATIONS OF THE INITIATIVE
This proposal will have practical implications for all those in the private, public and non-
governmental sectors who are active in the marketing of PRM and FRM. This includes operators
(breeders of new varieties, seed multipliers, companies marketing PRM and FRM, organisations
engaged in conservation and sustainable use of plant and forest genetic resources), NCAs
responsible for the acceptance of new varieties and the certification of PRM and FRM and the
relevant OCs.
1.1.
Operators
Breeders and/or applicants for the registration of new varieties of the regulated species will have to
meet more elaborated criteria as regards the contribution of these varieties to a more sustainable
agri-food production. This may result in increased breeding costs and lower numbers of new
varieties being authorised for marketing, at least in the first years after entry into force of the new
requirements until breeding programmes can be adjusted to the new requirements.
Producers of FRM will have to assess FRM for characteristics contributing to sustainable
production and make available to buyers/users of FRM information on the suitability of FRM for
climatic and ecological conditions. Producers of FRM for specific non-forestry purposes will have
to meet the requirements of the FRM legislation (approval of basic material, rules on provenance,
certification of FRM).
All other measures do not result into new obligations for operators but provide them with new
options (additional certification tasks possible under official supervision, VSCU examination under
official supervision, digitalisation of documents, use of BMTs, use of innovative production
methods). In order to make use of some of these new options, operators may have to reallocate their
resources and/or carry out some investment. The extent of such investments will largely depend on
the current situation, e.g. using the option for additional certification tasks will be much easier and
will probably require no significant investments for operators already carrying out certification
tasks under official supervision. Other measures will provide lighter conditions for accessing the
market (organic varieties suitable for organic production, conservation and locally adapted
varieties, heterogeneous material), without resulting into new obligations.
1.2.
National competent authorities
Extension of the certification tasks that may be carried out under official supervision is expected to
require that NCAs will have to reallocate staff from official certification activities to training and
supervision activities. The impact of this will depend on the demand by operators to carry out
additional tasks under official supervision.
Extension of the current VCU requirements for agricultural plant species and vine to better address
sustainability and introduction of sustainability requirements for all other crop groups (vegetables
and fruit plants) in the procedure of acceptance of new varieties will require that NCAs increase
their capacity in terms of staff and testing stations. This impact will be mitigated by a transition
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period before these requirements enter into force, permitting these examinations to take place under
official supervision at the premises of the operators and allowing the cooperation between the MS.
Harmonisation of OCs on production, marketing and imports of PRM/FRM and subjecting them to
the OCR, as well as moving the lists of RNQPs and specific measures to the PHL with PRM/FRM
legislation referring to them instead of duplicating them, will also require NCAs to reallocate some
of their resources (depending on current allocation between PHL and PRM/FRM certification) or
increase their resources in case they don’t already meet the minimum rates of OCs to be introduced.
OCs subject to OCR will also mean that NCAs will have to include OCs on PRM and FRM in the
multi-annual national control plan and to publish an annual report on the number of OCs carried out
and the outcome of those controls, but several NCAs already follow these practices despite not
being an obligation currently.
Adapted DUS and VCU requirements for the examination of organic varieties suitable for organic
production will require that NCAs allocate staff and testing stations to test these.
Lighter rules for seed conservation networks, marketing to amateur gardeners and exchange in kind
of seed, simplification of current rules for conservation varieties and extension of those rules to
cover new locally adapted varieties and broadened scope for heterogeneous material beyond
organic production on the one hand will require dedicated staff for their implementation. On the
other hand, removal of some of the current requirements (variety registration and PRM
certification) will mitigate this impact.
Extension of the scope of FRM legislation to include the production of FRM for specific non-
forestry purposes, extension of sustainability requirements to cover lower FRM categories, and
introduction of a requirement for contingency planning to ensure availability of FRM may also
require an increase in the resources of the NCAs.
1.3.
Users of PRM and FRM
There are no new obligations for the users of PRM and FRM resulting from this initiative as the
scope of the legislation does not cover the use and the users of PRM and FRM. However, the
increased sustainability assessment may lead to a marginal increase of price of inputs (seed and
other PRM) for farmers, but the initiative is expected to lead to increased availability of PRM and
FRM for all types of users, and to PRM and FRM being more suitable for meeting future
challenges. Consequently, users of PRM and FRM will benefit from a higher stability of their
income under adverse conditions.
2.
S
UMMARY OF COSTS AND BENEFITS
The estimates of costs and benefits refer to the preferred option in relation to the baseline. The main
recipient of the benefit is indicated in the comments’ column.
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I. Overview of Benefits (total for all provisions) – Preferred Option
Description
Amount
Direct and indirect benefits
All certification tasks are permitted
under official supervision except the
issuing of the official label.
Strengthened sustainability
requirements
Harmonisation of official controls
subject to OCR
Decisions for addition of new species
in (or removal of species from) the
scope of the PRM legislation and on
the equivalence to EU rules for third
countries will be taken by means of
tertiary legislation.
Lighter rules for seed conservation
networks, marketing to amateur
gardeners and exchange in kind of
seed, simplification of current rules
for conservation varieties and
extension of those rules to cover new
locally
adapted
varieties
and
broadened scope for heterogeneous
material.
The possibility to deviate from
certain DUS requirements as regards
uniformity will be provided for the
DUS examination of organic varieties
suitable for organic production.
EUR 1.7 million per year in reduced
certification costs
198
(direct benefit)
Efficiency gains and flexibility, not
monetised (indirect benefits)
Avoided loss in crop output ranging from
EUR 621 to 2 486 million annually (indirect
benefit)
Reduced losses in forestry (indirect benefit,
not monetised)
Efficiency gains
monetised)
(direct
benefit,
not
Comments
Operators
Farmers
Foresters
NCAs
Commission
NCAs
Operators
Shorter time to reach such decisions but the
benefits are rather limited as only a small
number of decisions every year (0-4) are
concerned. Not monetised.
Operators would benefit from lighter
procedures for access to market. Number of
operators and quantities of PRM concerned
are unknown. Though number of operators
could be in the range of several thousands,
the quantities of PRM concerned are
considered to be limited. New market
opportunities could have a value of up to
EUR 266 million annually.
Operators:
Several
hundred
varieties
or
heterogeneous
material to be brought in the
market over the next ten years.
The breeding period of varieties compliant with
reduced uniformity requirements can be in
average 2 years shorter than for varieties fully
meeting those requirements.
Operators making use of this possibility will
therefore access the market faster, with reduced
breeding costs and with varieties that up to now
were restricted from the market since it was not
possible to register varieties not meeting the
DUS requirements.
A few dozen operators across EU are likely to
use this option. The number of varieties
registered under these rules could be in average
100 annually. Assuming EUR 50 000 savings in
breeding costs per variety, concerned operators
may see savings of EUR 5 000 000/year.
Operators
Administrative cost savings related to the ‘one in, one out’ approach
The transfer/notification of new The period between acceptance in a national
Commission: need for adoption of
varieties from national to Common catalogue and access to the common market will
24 Decisions every year and
198
The certification costs are considered as
testing costs
and not as
administrative costs.
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Catalogues will be managed by the be shortened by 1 to 4 months for about 4 000
MS without the need for a new varieties every year. Not monetised.
Commission Decision.
Allow MS to decide themselves on
permitting temporarily the marketing
of seed that does not satisfy the
requirements in respect of minimum
germination, if germination is not
lower than 15 % than the required
germination rate.
In average 30 notifications annually (for a total
of 50 000 tonnes of seed, or about 0.01% of the
quantities of seed certified annually) become
redundant. Not monetised.
publication of the Common
Catalogues in the Official Journal
is removed
Operators:
avoidance
of
unnecessary waiting time
Commission and NCAs: avoiding
the handling of on average 30
notifications per year and
adoption
of
corresponding
Commission Decisions.
Operators: Reduced waiting time
by at least 15 days for each
notification avoided.
Operators
All professional operators to be Over 20 000 duplicate registrations will be
registered in a single register under avoided and over EUR 800 000 annual savings in
the PHL.
registration costs for operators supplying PRM
of fruit plants. Over 4 000 duplicate registrations
will be avoided and there will be over EUR 237
000 annual savings in registration costs for
operators supplying FRM
II. Overview of costs – Preferred option
Citizens/Consumers
One-off
Direct adjustment
costs
Direct administrative
costs
Direct regulatory fees
and charges
Strengthened
sustainability Direct enforcement
requirements costs
Indirect costs
N/A
N/A
Businesses
One-off
Recurrent
Administrations
One-off
Recurrent
Recurrent
N/A
N/A
N/A
N/A
Increased registration
costs: EUR 6.4 million
annually (PRM)
EUR 43 to 98
million annually
Up to 200 varieties less
(or 5% less) registered
every year (PRM)
N/A
N/A
N/A
EUR 400 million
annually
in
increased
PRM
costs for farmers,
corresponding
to
3% increase in cost
of PRM or 0.15%
increase in cost of
global inputs
Direct adjustment
Harmonisatio
costs
n of OCs
subject
to
OCR
Direct administrative
costs
N/A
N/A
Reallocation of
resources,
depending
on
current
organisation
Globally neutral
impact.
Modified rate of OCs
(increase or decrease)
depending on current
Multi-annual
national
control plan
N/A
N/A
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situation
Globally
impact.
Direct regulatory fees
and charges
N/A
N/A
per
MS.
neutral
Annual report
on OCs
Direct enforcement
costs
N/A
N/A
Depending
on
current
implementation (not
quantifiable).
Globally
neutral
impact.
Indirect costs
N/A
N/A
Costs related to the ‘one in, one out’ approach
Direct adjustment
costs
Total
Indirect adjustment
costs
Administrative costs
(for offsetting)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
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R
ELEVANT SUSTAINABLE DEVELOPMENT GOALS
III. Overview of relevant Sustainable Development Goals – Preferred Option(s)
Relevant SDG
Expected progress towards the Goal
SDG 2 – End hunger,
achieve food security and
improved nutrition and
promote
sustainable
agriculture
The simplification of the legal framework and its adjustment to
recent scientific and technical developments will increase the
efficiency of the system and support the competitiveness of the
EU PRM sector. In turn, this will contribute in securing the
availability and affordability of PRM in the EU. As PRM is the
starting point and critical input for the agri-food production, this is
SDG
12
–
Ensure also a direct contribution towards achievement of food security
sustainable consumption and (SDG 2).
production patterns
The assessment of new varieties for sustainability characteristics
SDG 13 – Take urgent will steer breeding efforts towards improved varieties with higher
action to combat climate and more stable yields (SDG 2), improved water and nutrients
change and its impacts
efficiency and increased resistance to plant pests, contributing to
reduced reliance of agri-food production on inputs like water,
SDG 15 – Protect, restore fertilisers and plant protection products (SDG 12), better
and promote sustainable use performing under the climate change conditions, contributing to a
of terrestrial
strengthened resilience and adaptive capacity of agri-food
ecosystems,
sustainably production to climate-related hazards and natural disasters (SDG
manage forests, combat 13).
desertification, and halt and
reverse land degradation and Measures for facilitating the registration of organic varieties
halt biodiversity loss
suitable for organic production will contribute to the further
expansion of organic farming, which produces high quality food
with low environmental impact (SDGs 2 and 12).
Measures for facilitating the availability of conservation varieties
and other locally adapted varieties, exchange in kind of seed and
the use of heterogeneous material will contribute to the
sustainability of agricultural production in marginal areas (SDGs
2 and 12). Furthermore, these measures will contribute to
increased genetic diversity of cultivated plants (SDG 15), which
again is a contribution to SDG 2, as the breeding of improved
varieties relies on this genetic diversity.
Measures for assessing FRM for characteristics contributing to
sustainable production (resistance to pests, suitability for climatic
conditions), making available information to users/buyers of FRM
on the suitability of FRM for climatic and ecological conditions,
contingency planning ensuring the availability of FRM will enable
the availability and use of the most appropriate FRM for each
location, therefore contributing to a more sustainable forest
management and afforestation (SDGs 12, 13 and 15). Facilitation
of the registration of basic material for the purposes of
conservation of forest genetic resources will also contribute to the
achievement of SDG 15.
Comments
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A
NNEX
4: A
NALYTICAL METHODS
/ C
ALCULATIONS
1.
G
LOBAL VALUE OF
PRM/FRM
AND COST OF
PRM
AS A SHARE OF TOTAL INPUT COSTS OF
AGRICULTURAL PRODUCTION
According to information retrieved from Eurostat economic accounts for agriculture
199
,
the total
value in EU27 of seeds and planting stock used in agriculture as input in the production
200
in
2021 was 13.3 billion EUR.
This value covers the total consumption of bought-in domestic and
imported seeds and planting stock for current production and maintaining stocks in vineyards,
orchards, and Christmas tree plantations. It includes in particular direct purchases of seeds and
planting stock from other farmers. However, it does not include seed produced and consumed
within the same unit
201
. It also does not include seeds and planting stock sold to amateur gardeners.
It includes PRM of species not subject to the PRM legislation and therefore provides the upper limit
of the value of PRM covered by the PRM legislation. The overestimate is not considered excessive,
as the PRM legislation covers the economically most important species.
The amount of EUR 13.3 billion represents in comparison to 2010 an increase of 24.77% (values at
constant prices, 2010 = 100) and an increase of 27.84% in current values. The evolution in current
prices is comparable to that of the total value of all inputs (total intermediate consumption) and to
that of plant protection products. The cost of seeds and planting stocks as a percentage of the total
intermediate consumption has remained stable at around 5.2% but this is only an indicative average,
as seeds and planting stock are input mainly for crop production, while the total intermediate
consumption includes all input for all sectors including the livestock sector.
199
200
https://ec.europa.eu/eurostat/web/agriculture/data/database
See point 2.089 of Annex I of Regulation (EC) No 138/2004 on the economic accounts for agriculture in the
Community.
201
See point 2.097 of Annex I of Regulation (EC) No 138/2004 on the economic accounts for agriculture in the
Community.
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Year
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
Evolution between 2010-
2021
(constant prices, 2010 =
100)
Constant prices (2010 = 100) in million EUR
Total intermediate
consumption
Seeds and planting stock
200.843,86
200.340,25
202.561,99
202.725,39
201.365,51
201.771,43
205.928,91
202.797,05
205.244,50
208.589,48
209.352,92
210.845,06
212.882,43
215.706,45
215.873,54
218.111,87
220.084,44
9.267,60
9.537,09
9.622,62
9.973,34
9.609,87
10.439,09
10.463,09
10.071,73
10.187,92
10.491,53
10.724,34
10.872,46
11.105,58
11.342,27
11.465,32
11.442,48
11.563,71
Fertilisers and
improvers
16.372,26
16.004,65
16.199,51
14.484,88
12.991,40
13.751,84
14.122,28
13.905,10
14.777,15
15.177,37
15.077,51
15.289,65
15.310,92
15.535,67
15.333,82
15.405,23
15.340,85
Plant protection
products
9.132,67
8.939,98
9.087,47
9.790,25
9.518,42
9.200,33
9.465,13
9.664,09
10.123,11
10.531,11
10.593,68
10.682,33
10.611,95
10.584,32
10.593,60
10.538,50
10.980,05
9.08%
24.77%
Current prices in million EUR
-6.29%
19.34%
Year
2010
Total intermediate
consumption
201.771,43
Share of total intermediate
consumption
260.167,89
Share of total intermediate
consumption
Seeds and planting stocks
10.439,09
5.17%
13.345,85
5.12%
Fertilisers and
improvers
13.751,84
6.82%
19.599,82
7.53%
Plant protection
products
9.200,33
4.56%
11.828,69
4.54%
2021
Evolution between 2010-
2021
(current prices)
28.94%
27.84%
42.52%
28.56%
Table 16. Value of PRM as input to agricultural production and its evolution (calculations based on data retrieved from
Eurostat).
Data retrieved from the farm accountancy data network (FADN)
202
was used to estimate
203
the cost
of seeds and plants (PRM) as a share of total intermediate consumption (total input costs) for the
202
http://agridata.ec.europa.eu/extensions/FADNPublicDatabase/FADNPublicDatabase.htmlhttps://agridata.ec.europa.eu/e
xtensions/FADNPublicDatabase/FADNPublicDatabase.html
203
DG SANTE in-house calculations.
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eight different types of farming defined in FADN. This is compared to the share of fertilisers and
plant protection products. These estimates are considered indicative as they express only the FADN
surveyed farm populations
204
. Furthermore, the FADN data structure does not allow calculating by
extrapolation total values
205
. Nevertheless, the FADN data indicates that the cost of seeds and
plants as share of the total intermediate consumption is more important in horticulture (largely
corresponding to the vegetable species) and double than the share for field crops (largely
corresponding to the agricultural plant species).
Cost of main input categories as share of the total intermediate consumption for the different types of farming
Average for the period 2018-2020 for EU27
Type of farming
Field crops
Horticulture
Wine
Other permanent crops
Milk
Other grazing livestock
Granivores
Mixed farms
Global average
Seeds and plants
13.61%
26.97%
1.52%
2.39%
2.65%
2.40%
1.24%
4.53%
6.73%
Fertilisers
16.37%
6.36%
6.53%
16.15%
4.40%
4.37%
1.37%
6.36%
9.83%
12.04%
5.15%
11.49%
14.19%
1.45%
7.04%
1.22%
4.08%
7.75%
Plant protection products
Table 17. Cost of main input categories as share of the total intermediate consumption for the different types of farming
(average for the period 2018-2020 for EU27), calculations based on data retrieved from FADN.
The global average share of seeds and plants to the total intermediate consumption derived from the
two datasets is comparable, therefore it is assumed that the share of “seeds and planting stocks” to
“total intermediate consumption” according to Eurostat data can be used for further calculations.
No similar data are available in relation to FRM in Eurostat and FADN.
2.
N
UMBER OF NEW VARIETIES
The Common Catalogues were used to calculate the average number of new varieties registered
annually over the period 2012-2021. It is assumed that due to the envisaged measures for increased
sustainability requirements in the examination of candidate varieties, it will become more difficult
to register new varieties. A number of varieties that would have been registered under the baseline
will be either withdrawn by the applicants or rejected. This impact is expected to be lowest for
agricultural plant species, where the VCU is already in place. For the other crop groups, the impact
of sustainability assessment would be lowest in option 1 (reliance on information that applicants
voluntarily submit along with the application for registration of a new variety). For all crop groups,
the impact would be highest in option 3 as highly harmonised rules would be most difficult to
comply with.
204
The FADN survey does not cover all the agricultural holdings in the Union, but only those which are of a size
allowing them to rank as commercial holdings. The FADN weighting system has been optimised with a view to
providing good averages for groups rather than good total values for groups. Taken from the document “FADN
definitions of variables in FADN standard rules”.
205
The FADN used a weighting system optimised for providing good averages for groups rather than good total values
for groups. Taken from the document “FADN definitions of variables in FADN standard rules”.
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Average number of new
plant varieties per year
Option 1
Additional
withdrawal
and/or
rejection
rate 3%
Agricultural plant species
2 564
2 487
Vegetable species
1 384
1 342
Vine
41
40
Fruit plants
39
38
Table 18. Average number of new plant varieties per year.
Baseline
1
Option 2
Additional
withdrawal
and/or
rejection
rate 5%
2 435
1 315
39
37
Option 3
Additional
withdrawal
and/or
rejection
rate 10%
2 308
1 246
37
35
3.
PRM
CERTIFICATION AREAS
/
CERTIFIED QUANTITIES AND CERTIFICATION UNDER OFFICIAL
SUPERVISION
ESCAA category
Cereals
Potatoes
Maize and sorghum
Forage and turfgrass
Oil crops
Pulses
Beets and chicory
Fibre crops
Vegetables
Certified seed quantities
(in tons) in 2020 (EU27)
3 988 386.90
2 443 652.30
572 810.70
397 890.91
198 757.00
191 373.30
179 725.80
17 239.20
8 594.96
TOTAL
7 998 431.07
Table 19. Certified seed quantities per ESCAA crop categories (in tons) in 2020 (EU27) (calculated on basis of data
retrieved from escaa.org).
CERTIFIED SEED QUANTITIES in EU in 2020 (tonnes)
Common name
Seed potatoes
Wheat
Barley
Maize (except popcorn and sweet corn)
Forage and turfgrass
Durum wheat
Triticale (hybrid of wheat and rye)
Oat
Rye
Sugar beet
Soja bean
Rice
Latin name
Solanum tuberosum
L.
Triticum aestivum
L.
Hordeum vulgare
L.
Zea mays
L.
Various species
Triticum durum
desf.
Triticosecale
wittm.
Avena sativa
L.
Secale cereale
L.
Beta vulgaris
L.
Glycine max
(L.)
Oryza sativa
L.
Total
2.443.652,30
2.095.709,00
1.029.853,70
568.833,20
397.890,91
297.390,40
251.942,20
175.221,10
151.386,40
99.347,20
92.943,20
60.607,80
93
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Sunflower
Spelt wheat
Flax for fibres
Bristle oat
Cotton
Flax for oil
Sorghum
Hemp
Fodder beet
Sudan grass
Groundnut (peanut)
Poppy
Safflower
Canary grass
Helianthus annuus
L.
Triticum spelta
L.
Linum usitatissimum
L.
Avena strigosa
L. Schreb.
Gossypium
spp.
Linum usitatissimum
L.
Sorghum bicolor
(L.) Moench
subsp. bicolor
Cannabis sativa
L.
Beta vulgaris
L.
Sorghum x drummondii
Arachis hypogaea
L.
Papaver somniferum
L.
Carthamus tinctorius
L.
Phalaris canariensis
L.
50.743,30
25.690,20
15.054,90
13.794,00
8.280,40
6.086,50
2.572,60
2.184,30
1.150,40
317,50
226,40
211,70
159,20
113,30
Caraway
Carum carvil
L.
50,40
Table 20. Certified seed quantities per species (in tons) in 2020 (EU27) (calculated on basis of data retrieved from
escaa.org).
EU area for seed production (1000 ha, excluding vegetables)
Member State
France
Italy
Germany
Spain
Poland
Denmark
Romania
Hungary
Czech Republic
Sweden
Rest of the MS (incl. UK for 2018 and 2019)
2018
355
201
177
187
146
152
140
113
100
63
339
2019
357
191
195
185
147
162
138
114
102
60
361
2020
363
199
198
179
166
163
161
118
103
65
367
2021
372
205
195
183
173
164
139
118
111
67
368
EU total
1973
2012
2082
2095
Top 10 MS share
82.82% 82.06% 82.37% 82.43%
Table 21. EU area for seed production per MS (1000 ha, excluding vegetables) (calculated on basis of data retrieved
from escaa.org).
Area for seed production by species (1000 ha)
% of
total
area
23%
25%
13%
6%
7%
% of
total
area
23%
24%
13%
5%
8%
% of
total
area
22%
24%
13%
4%
8%
% of
total
area
21%
26%
12%
5%
9%
Average
2018-
2021
459
505
255
99
164
Species
Soft wheat
Forage and turf
Barley
Durum wheat
Corn
2018
457
485
248
109
140
2019
470
482
259
96
152
2020
468
508
263
90
174
2021
440
546
250
101
190
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Potatoes
102
5%
106
5%
109
5%
109
5%
107
Sunflower, soja and
rapeseed
113
6%
112
6%
108
5%
106
5%
110
Table 22. Species with highest areas for seed production in EU 2018-2021 (calculated on basis of data retrieved from
escaa.org).
The possibility will be introduced to carry out under official supervision for the certification
activities for which it is currently not possible:
Certification
activity
Field
inspections
for bred seed of
generations prior to
basic seed (pre-
basic seed)
Field
inspections
for basic seed
Agricultural plant species
(except from seed potatoes)
Possibility to carry out under
official supervision will be
introduced
Vegetable species
Possibility to carry out
under official supervision
will be introduced
Seed potatoes
Possibility to carry out
under official supervision
will be introduced
Possibility to carry out
under official supervision
will be introduced
Field
inspections
Possibility to carry out
for certified seed
under official supervision
will be introduced
Seed sampling
Currently possible
under Currently possible under Possibility to carry out
official supervision
official supervision
under official supervision
will be introduced
Seed testing
Currently possible
under Currently possible under Possibility to carry out
official supervision
official supervision
under official supervision
will be introduced
Table 23. Scope of the measure of extension of certification activities permitted under official supervision.
Possibility to carry out under
official supervision will be
introduced
Currently possible
under
official supervision
Possibility to carry out
under official supervision
will be introduced
Currently possible under
official supervision
The generations of pre-basic and basic seed constitute up to 2% of the quantities of certified seed
and the areas of production
206
.
In EU every year about 2 million hectares
207
are used in average for the production of certified
seed, of which 1.9 million hectares for agricultural plant species other than seed potatoes and 0.1
million hectares are for seed potatoes. The areas used for the production of certified vegetable seed
are in comparison insignificant (about 2 500 hectares).
Furthermore, in EU every year about 8 million tons of seed in average are certified, of which 5.54
million tons of agricultural plant species other than seed potatoes, 2.44 million tons of seed potatoes
and 0.01 million tons of vegetable seed.
The measures therefore concern:
For agricultural plant species (except from seed potatoes) the certification of up to 2% * 1.9
= 0.04 million hectares and of 2% * 5.54 = 0.11 million tons of pre-basic and basic seed
annually.
206
Own estimation in absence of more accurate data, based on an average multiplication rate of 100 between
subsequent generations.
207
Average for the years 2018-2021, source: escaa.org.
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For seed potatoes, the certification of up to 0.1 million hectares and 2.44 million tons of
seed potatoes.
Small areas and quantities as regards vegetable seed.
140 000
10
1 400 000
180 000
2 550 000
5
12 750 000
1 530 000
1 710 000
Potential annual savings for operators by extension of certification activities possible under official supervision
a) Area becoming eligible for certification under official supervision (ha)
b) Average annual cost for official certification (EUR/ha)
c) Total annual cost for official certification (EUR) (a*b)
d) Potential annual savings for operators by switching to certification under official supervision (EUR) (c*12%)
e) Seed quantities becoming eligible for certification under official supervision (tons)
f)
Average annual cost for under official supervision (EUR/ton)
g) Total annual cost for official certification (EUR) (e*f)
h) Potential annual savings for operators by switching to certification under official supervision (EUR) (g*12%)
Total potential annual savings for operators by switching to certification under official supervision (EUR) (d+h)
Table 24. Calculation of the potential annual savings for operators by extension of certification activities possible under
official supervision.
Extending the possibilities for operators to carry out certification activities under official
supervision is not expected to have significant impacts on enforcement costs for NCAs. On the
basis of experience gained by a temporary experiment
208
, it is expected that if there is high demand
by operators, NCAs rather risk a reduction of the competence and the jobs for their official
inspectors
209
. NCAs will also need to reallocate resources from carrying out official inspections to
training, licensing and supervising the operators’ inspectors. Overall, the impact on NCAs will
largely depend on the demand by the operators but it is considered to be neutral and/or
insignificant, as already certification under official supervision is possible for the certified
categories (except seed potatoes) that are assumed to constitute 98% of areas and of quantities.
The demand by operators is expected to depend largely on the quantities to be certified, with lower
willingness to invest in own inspectors when quantities are lower. The size of the company (small,
medium or big) does not seem to affect the ability to use the option for official supervision.
Operators opting for official supervision are likely to bear one-off (upfront) costs for setting up
laboratories and recurrent costs for hiring and training staff in order to use this option, however the
responses to the related survey did not provide data allowing to calculate the scale of such costs.
However, survey results
210
indicate that around 50% of operators (valid also for SMEs) already use
the existing options for official supervision and would make use of certification conducted by
operators under official supervision for all steps of the seed certification process if this was made
available. Survey data also indicate that obtaining a certification under official supervision is
estimated to be around 12% less costly to operators than certification performed by MS
authorities
211
. If all operators opt to carry out certification activities under official supervision under
the new possibilities introduced, the potential annual cost saving for operators would be around
EUR 1.7 million (Table 24). These savings are rather insignificant, but survey responses indicate
208
Temporary experiment on field inspection under official supervision for pre-basic and basic seed 2012-2019 - final
report, available at
https://food.ec.europa.eu/system/files/2022-04/prm_temp-exp_field-inspec_en.pdf
209
The impact assessment of 2013 (SWD(2013) 162 final) estimated that up to 700 public sector jobs might be lost if
all fields and seed lots of pre-basic and basic seed were inspected by operators under official supervision. Part of this
staff would be recruited in the private sector.
210
ICF (2023) and SME targeted survey.
211
ICF (2023) Section 6.1.1.1.
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that operators appreciate the efficiency gains and flexibility resulting from carrying out certification
under official supervision, expecting that in the long term there will be more significant savings.
These impacts are most relevant for agricultural plant species, as 95% of the seed of vegetable
species is not certified but marketed as standard seed. There are no data available to allow an
estimation of cost and benefits from introducing the option to carry out certification under official
supervision of PRM for fruit plants and of FRM.
4.
V
ARIETY REGISTRATION COSTS
The costs for operators for variety registration currently consist of administrative costs (submission
of an application), the cost of DUS examination and for the agricultural plant species the cost of the
VCU examination. In the case of vine, there is an examination similar to the VCU examination, but
this is carried out in the frame of the DUS examination. Under all options there will be no changes
in the component of administrative costs and DUS examination. The envisaged measures for
strengthening
sustainability requirements
in the VCU examination of agricultural plant species
and vine and the introduction of an obligation for assessment for characteristics that contribute to
sustainable agri-food production of new varieties of the other crop groups (i.e. vegetables and fruit
plants) will result in
additional testing costs for operators
(increased fees paid to NCAs for the
examination of new varieties).
The current average cost for VCU for agricultural plant species is EUR 3 200 per year and on
average VCU examination is carried over two years. The assessment for characteristics that
contribute to sustainable agri-food production of new varieties of the other crop groups is assumed
that will last for 2 years on average for vegetables, and for 4 years for fruit plants and vine
97
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option 2
option 3
Total increase
Total increase
Total increase
in variety
Increase per
Baseline: Average registration
Increase per
Increase per
in variety
Assumption on
in variety
Assumption on
registration Assumption on
variety in
cost (administrative fee + DUS
variety in
variety in
registration
additional
registration
additional costs
costs in
additional costs
relation to
+ VCU where applicable) for
relation to
relation to
costs in
costs for
costs in relation
for operators
relation to
for operators
baseline
operatorsper variety (EUR)
baseline (EUR)
baseline (EUR) relation to
operators
to baseline
baseline
(EUR)
baseline (EUR)
(EUR)
(EUR)
10% of current
10% of current
15% of current
VCU * 2 years
VCU * 2 years
VCU * 2 years
Agricultural plant species
[2.364 varieties]
[1.859 varieties]
[1.795 varieties]
EUR
640
1.512.960 EUR
640
1.189.760 EUR
960
1.723.200
10.915
%
6%
%
6%
%
9%
10% of current
80% of current
100% of current
Vegetable species
VCU * 2 years
VCU * 2 years
VCU * 2 years
[1.314 varieties]
[1.003 varieties]
[969 varieties]
EUR
640
840.960 EUR
5.120
5.135.360 EUR
6.400
6.201.600
5.580
%
11%
%
92%
%
115%
10% of current
10% of current
15% of current
Vine
VCU * 4 years
VCU * 4 years
VCU * 4 years
[39 varieties]
[30 varieties]
[29 varieties]
EUR
1.280
49.920 EUR
1.280
38.400 EUR
1.920
55.680
13.840
%
9%
%
9%
%
14%
10% of current
110% of current
120% of current
Fruit plants
VCU * 4 years
VCU * 4 years
VCU * 4 years
[37 varieties]
[28 varieties]
[27 varieties]
EUR
1.280
47.360 EUR
14.080
394.240 EUR
15.360
414.720
14.000
%
9%
%
101%
%
110%
Grand total of increase in
variety registration costs
(upper limit) for operators in
EUR
2.451.200
6.757.760
8.395.200
EU27
Grand total of increase in
variety registration costs
(lower limit) for operators in
EU27, assuming 44% of VCU
and sustainability assessments
under official supervision with
12% reduced costs
option 1
EUR
2.321.777
6.400.950
7.951.933
Table 25. Calculation of the total increase of variety registration costs for operators due to increased sustainability requirements (VSCU).
98
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The increase in variety registration costs relative to the baseline due to the new VSCU can reach to
EUR 2.45 million in option 1, EUR 6.75 million in option 2 and EUR 8.39 million in option 3 in
total for all operators in EU27 every year. This can be reduced to EUR 6.40 million and EUR 7.95
million under options 2 and 3 respectively following the application of mitigating measures (VSCU
examination under official supervision and collaboration between NCAs). These savings are
calculated by assuming that up to 44% operators will opt for official supervision and have 12%
savings in their costs (i.e. assuming the same percentage and savings recorded for certification
under official supervision).
5.
I
MPACT OF STRENGTHENED SUSTAINABILITY REQUIREMENTS IN VARIETY REGISTRATION
It is expected that the measures for strengthened sustainability requirements for the acceptance of
new varieties (VSCU) will result in increase of cost of seeds and other PRM for farmers. The main
driver of the increase of the costs is the reduced number of varieties that can be put on the market
that will increase the cost of breeding of new varieties. The return of the costs of breeding
programmes will depend on a smaller number of varieties. The assumed loss of new varieties will
be highest in option 3 and lowest in option 1 (Table 18). A secondary driver is the increase of cost
of examination of new varieties due to the strengthened sustainability requirements. The increase
will be highest in option 3 and lowest in option 1 (Table 25). In absence of data allowing more
accurate calculations, it is assumed that the total cost of PRM used in agriculture annually in EU27
will increase on average 1%, 3% and 5% under options 1, 2 and 3 respectively. This assumed
increase in prices is lower than the reduced number of varieties coming to the market (additional
rejection or withdrawal rate of varieties is assumed at 3%, 5%, 10% under options 1, 2 and 3
respectively) because it is observed that the returns on breeding investments come from only a part
of the varieties marketed, while some varieties are registered without being actually put in the
market.
On the other hand, farmers will benefit from the improved characteristics of the new varieties in
terms of improved use of inputs, reduction of loss of yield due to extreme conditions etc. Such
gains are being realised over the years due to a number of different factors, including genetic gains
by plant breeding, improved agronomic practices etc. The impact of these factors cannot be
disentangled. The strengthened sustainability requirements will contribute to the abovementioned
gains. The requirements will steer breeding to aspects as increased resistance to plant pests that will
lead to reduced pesticide use, increased drought tolerance and more efficient use of nutrients that
will lead to more stable yields in extreme conditions etc. Gains are expected to be lowest under
option 1 (voluntary approach for species other than agricultural plant species) and highest in option
2 (leaving flexibility to MS to adjust to local agro-ecological conditions). Option 3 is expected to
result in intermediate gains, as the level of flexibility for MS to adjust to local agro-ecological
conditions is limited. In absence of data allowing more accurate calculations, it is assumed that the
avoided loss of total crop output on top of the progress made anyway in the baseline can be used as
a proxy for all the benefits for farmers that derive from the improved characteristics of the new
varieties. This avoided loss of total crop output is assumed to be 0.5%, 1% and 0.75% under
options 1, 2 and 3 respectively. These assumptions are based on the average genetic progress that
has been recorded for various species over the last decades
212
. With these assumptions option 2
clearly outperforms, with option 1 delivering the least benefits. The uncertainty of these
212
E.g. Rijk B.
et al.
(2013); Voss-Fels K.P
et al.
(2019).
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assumptions is rather high. Therefore, in place of a sensitivity analysis, a conservative scenario
where the avoided loss of total crop output is assumed to be 4 times lower (0.13%, 0.25% and
0.19% under options 1, 2 and 3 respectively) is also examined. In this conservative scenario, option
2 also performs best, while for option 3 the costs are higher than the benefits.
Million EUR
(current 2021 price)
INCREASE IN COSTS
Total annual PRM cost in agriculture
Total annual intermediate
consumption in agriculture
BENEFITS
Total annual crop output
Balance / optimistic scenario
Total annual crop output
Balance / conservative scenario
248.656,89 Avoided loss in crop output annually (%)
(million EU)
million EUR
248.656,89 Avoided loss in crop output annually (%)
(million EU)
million EUR
0,50%
1.243,28
1.109,83
0,125%
310,82
177,36
1,00%
2.486,57
2.086,19
0,250%
621,64
221,27
0,75%
1.864,93
1.197,63
0,188%
466,23
-201,06
13.345,85 Increase in total PRM cost in agriculture (%)
(million EUR)
Increase in global intermediate consumption
due to increase in total PRM cost in agriculture
260.167,89 (%)
1%
133,46
3%
400,38
5%
667,29
Impact on farms of strengthened sustainability
requirements for the acceptance of new
varieties of PRM
Option 1
Option 2
Option 3
0,05%
0,15%
0,26%
Table 26. Impact on farms of strengthened sustainability requirements for the acceptance of new varieties of PRM
Impact on NCAs:
Currently 16 MS receive the bulk of the applications for new varieties of agricultural plant species
(corresponding to annual acceptance of 2 564 varieties on average every year). For meeting the
annual needs for implementing the VSCU for vegetable species and fruit plants (respectively 1 384
and 39 varieties on average accepted annually) the capacity of testing stations and staff would need
to be increased by up to 50% if all were to be carried out by the NCAs and by up to 22% if 44%
were done under official supervision (i.e. assuming the same rate as that for certification under
official supervision). Indicatively the annual budget of the French NCA responsible for variety
registration is EUR 30.6 million, of which approximately 60% corresponds to DUS activities and
40% to VCU (GEVES, n.d.). Assuming a similar budget for each of the 16 NCAs that receive the
bulk of the applications and that an increase in capacity by 22% to 50% would result in equal
increase in their budget, the total annual cost for the NCAs could be in the range of EUR 43 to 98
million in options 2 and 3 depending on the percentage of operators that will opt for official
supervision.
Total additional costs per NCA (16 largest ones):
EUR 30.6 million * 40% = EUR 12.24 million annual costs for VCU per NCA (baseline)
EUR 12.24 million * 50% = EUR 6.12 million additional annual costs per NCA without
official supervision (options 2 and 3)
EUR 12.24 million * 50% * 44% = EUR 2.69 million additional annual costs per NCA if
44% of operators opt for official supervision (options 2 and 3)
Total additional costs for NCAs (sum for 16 largest ones that cover the bulk of applications for
EU27):
16 * EUR 6.12 million = EUR 97.92 million without official supervision (options 2 and 3)
16 * EUR 2.69 million = EUR 43.04 million if 44% of operators opt for official supervision
(options 2 and 3).
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The costs for NCAs under option 1 are considered insignificant, as under that option NCAs are not
required to increase significantly their capacity.
6.
I
MPACT OF ASSESSMENT OF SUSTAINABILITY CHARACTERISTICS OF BASIC MATERIAL
The average annual fee for registration of new basic material is estimated to be EUR 1 491 based
on data provided by 4 MS
213
. Both the targeted survey and the data available in the Common
Catalogue (FOREMATIS) show that new basic material is on average registered every 5 years.
Based on the current annual average of 44 registrations of basic material in EU27 and assuming a
cost increase of 5%, 10% and 15% for options 1, 2 and 3 respectively, the annual average cost for
registration fee of basic material would be EUR 1 565, EUR 1 640 and EUR 1 714 under options 1
to 3 respectively.
Baseline
Fee for registration of new basic material
(EUR)
Number of registrations per year in
EU27
Additional cost per registration in
comparison to the baseline (EUR)
Total annual additional cost for
registration (EUR)
1 491
44
N/A
N/A
Option 1
1 566
44
75
3 280
Option 2
1 640
44
149
6 560
Option 3
1 715
44
224
9 841
Table 27. Calculation of total annual additional cost for registration of new basic material due to extended sustainability
assessment.
213
Data collected from NCAs by the targeted survey under ICF(2023).
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7.
I
NNOVATION AND DIGITALISATION
This section compares the costs of marketing controls that are conducted to confirm the identity of
the variety of the marketed PRM. Those marketing controls can be done by control-plot testing
(growing samples of the marketed PRM and comparing the phenotypic characteristics of those
sample with the reference sample of the registered variety) (Table 28). Alternatively, BMTs and
more specifically molecular markers
214
can be used to verify that the marketed PRM is identical to
the registered plant variety (Table 29).
As an estimate of the data provided by some NCAs, and extrapolating across the EU, it can be
concluded that around 50 000 post control tests are carried out per year on seed lots.
The following costs are estimates of the costs borne by NCAs to confirm the identity of a plant
variety.
Activity
Average Cost
Maintenance collection plots
2 450 EUR/ha
Post-control tests per lot
250 EUR/lot
Table 28. Estimation of the costs borne by NCAs to confirm the identity of a plant variety
Equipment/staff
Cost
Consumables + equipment
33 EUR/test
Cost basic PCR machine
5 000 – 15 000 EUR
Amortisation equipment
10 years
Staff cost
50 EUR/test
Other fixed costs
20 EUR/test
Table 29. Estimation of the costs as regards the use of BMTs
In 10 years’ time, 500 000 tests will be carried out. This will entail a total cost of 125 000 000
EUR. If 40% of those post control plot tests were done with BMTs (mainly those test that are more
appropriate for the species, e.g., fruit plants, vine, vegetables...) this would lead to significant
savings: 250- (33 + 50 + 20) =147 EUR saving per test; 147 x 500 000 x 40% = 29 400 000 EUR.
The investment needed to carry out these tests will be worthwhile given the significant savings of
using BMT instead of post control plot tests for some species.
Similarily, digitalisation of the certification system will require initial investments that can be paid-
off over few years, after which there will be net benefits. OECD carried out a feasibility study on
digitalisation to introduce
digital technologies
in seed certification. The study estimated the initial
investment by the OECD Secretariat to be in the range of 301 000 – 481 000 USD while the
tangible benefits for NCAs and operators were estimated at 398 000 USD over a period of 3 years
but would continue to be realised in the longer term
215
.
214
A molecular marker (identified as genetic marker) is a fragment of DNA that is associated with a certain location
within the genome. Molecular markers are used in molecular biology and biotechnology to identify a particular
sequence of DNA in a pool of unknown DNA.
215
OECD document TAD/CA/S(2021)8 OECD Seed Schemes Digitalisation Study – not published
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8.
D
ETAILED PRESENTATION OF COSTS AND BENEFITS
8.1.
Costs of common measures
PRM/FRM users
Operators
0
NCAs
Overview of costs of measures common to all options
All professional operators
to be registered in a single
register under the PHL
0
N/A
[NCAs currently maintain registers of professional
[Professional operators are currently registered either under the
operators either under the marketing Directives, or PHL, or
marketing Directives, or PHL, or both]
both]
The measure provides an additional option to operators and does not
create an obligation for them, therefore it does not lead to new costs.
Operators wishing to use this new option may however need to
invest in staff and/or equipment.
Around 50% of operators (valid also for SMEs) already use the
existing options for official supervision and would make use of
certification conducted by operators under official supervision for all
steps of the seed certification process if this was made available.
Those operators would not need any new investments. The potential
needs for investments by other operators cannot be monetised.
However, available data show that costs for operators are 12% less
for carrying out activities under official supervision in comparison to
the costs they have under official examinations
All certification tasks are
permitted under official
Measures
supervision except the
common to
N/A
issuing of the official label
all options
(PRM) and the Master
for PRM and
certificate (FRM).
FRM
legislation
NCAs will need to reallocate resources from carrying out
official inspections to training, licensing and supervising
the operators’ inspectors. The costs for NCAs will largely
depend on the demand by the operators but are expected to
be overall neutral or insignificant.
PRM/FRM legislation will
directly refer to PHL for
the list of RNPQs and
specific measures.
Compliance with
N/A
requirements for QPs and
RNQPs will remain a
prerequisite for the
certification of PRM/FRM.
Measures
common to
all options
for PRM
Decisions for addition of
new species in (or removal
N/A
of species from) the scope
of the PRM legislation and
0
[Requirements remain the same]
0
[Requirements remain the same]
N/A
N/A
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legislation
Decisions on the
equivalence to EU rules for
third countries will be
taken by means of tertiary
legislation
The transfer/notification of N/A
new varieties from national
to the EU Plant Variety
Portal will be managed by
the MS without the need
for a Commission Decision
Allow MS to decide
themselves on permitting
temporarily the marketing
of seed that does not
satisfy the requirements in
respect of minimum
germination, if
germination is not lower
than 15 % than the
required germination rate
The possibility to deviate
from certain requirements
as regards uniformity will
be provided for the DUS
examination of organic
varieties suitable for
organic production.
The rules for conservation
varieties are lighter and
extended to cover new
locally adapted varieties
The scope for
heterogeneous material is
broadened beyond organic
production
The current simple regime
for ornamental plants is
N/A
N/A
N/A
N/A
0
N/A
0
Negligible costs not quantified.
[The registration of organic varieties will be subject to the same [Some training of examiners may be required in order to
procedure as currently but an option is provided for such varieties to implement the deviation rules.]
deviate from uniformity requirements of the DUS examination.]
N/A
0
Negligible costs not quantified.
[Current rules are simplified and scope is extended, without addition
of new requirements]
[Some training of staff may be required in order to
implement the new rules]
0
[Current rules remain unchanged, only scope is extended]
0
[Current rules remain unchanged, only scope is extended]
N/A
N/A
0
[Current rules remain unchanged]
0
[Current rules remain unchanged]
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maintained unchanged
Measures
common to
all options
for FRM
legislation
The decisions on the
N/A
equivalence to EU rules for
third countries will be
taken by means of tertiary
legislation.
The existing empowerment N/A
to define the information to
be made available to
users/buyers of FRM is
extended to explicitly
cover suitability of FRM
for climatic and ecological
conditions.
N/A
N/A
Negligible costs not monetised
[Additional information can be easily made available within the
existing procedure]
N/A
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8.2.
Measures
Benefits of common measures
PRM/FRM users
Operators
EUR 1 million per year savings in registration costs
NCAs
Overview of benefits of measures common to all options
All professional operators
to be registered in a single
register under the PHL
N/A
Marginal savings due to the fact that there will be no
[Over 20 000 duplicate registrations will be avoided and over EUR 800
obligation to keep separate registers of professional
000 annual savings in registration costs for operators supplying PRM of
operators under PRM/FRM legislation and PHL. Not
fruit plants. Over 4 000 duplicate registrations will be avoided and there
monetised.
will be over EUR 237 000 annual savings in registration costs for
operators supplying FRM].
EUR 1.7 million per year in reduced certification costs (direct
benefit)
Efficiency gains and flexibility (indirect benefits not monetised )
Measures
common to
all options
for PRM and
FRM
legislation
All certification tasks are
permitted under official
supervision except the
N/A
issuing of the official label
(PRM) and the Master
certificate (FRM).
PRM/FRM legislation will
directly refer to PHL for
the list of RNPQs and
specific measures.
Compliance with
N/A
requirements for QPs and
RNQPs will remain a
prerequisite for the
certification of PRM/FRM.
Decisions for addition of
new species in (or removal
of species from) the scope
of the PRM legislation and
Decisions on the
N/A
equivalence to EU rules for
third countries will be
taken by means of tertiary
legislation
N/A
0
0
[Requirements remain the same. Efficiency gains and flexibility, not [Requirements remain the same. Efficiency gains and
monetised (indirect benefits)]
flexibility, not monetised (indirect benefits)]
Measures
common to
all options
for PRM
legislation
Shorter time to reach such decisions but the benefits are rather limited as Shorter time to reach such decisions but the benefits are
only a small number of decisions every year (0-4) are concerned. Not rather limited as only a small number of decisions every
monetised.
year (0-4) are concerned. Not monetised.
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The transfer/notification of PRM users can avail of about 4 000 new varieties every The period between acceptance in a national catalogue and access to the
new varieties from national year by 1 to 4 months earlier.
common market will be shortened by 1 to 4 months for about 4 000 new
to the EU Plant Variety
Not monetised.
varieties every year.
Portal will be managed by
Not monetised.
the MS without the need
for a Commission Decision
Allow MS to decide
themselves on permitting
temporarily the marketing
of seed that does not
satisfy the requirements in
respect of minimum
germination, if
germination is not lower
than 15 % than the
required germination rate
The possibility to deviate
from certain DUS
requirements as regards
uniformity will be
provided for the DUS
examination of organic
varieties suitable for
organic production.
Reduced waiting time for concerned PRM users by at least In average 30 notifications annually (for a total of 50 000 tonnes of seed,
15 days for each notification avoided. Not monetised.
or about 0.01% of the quantities of seed certified annually) become
redundant. Reduced waiting time for operators by at least 15 days for
each notification avoided. Not monetised.
For the Commission the need for adoption of 24 Decisions
every year is removed
For the NCAs the need to notify new varieties to the
Commission is removed. Not monetised.
In average 30 notifications annually (for a total of 50 000
tonnes of seed, or about 0.01% of the quantities of seed
certified annually) become redundant.
Commission and NCAs: avoiding the handling of on
average 30 notifications per year. Not monetised
Increased availability of organic varieties suitable for The breeding period of varieties compliant with reduced uniformity 0
organic production. Not monetised.
requirements can be in average 2 years shorter than for varieties fully
meeting those requirements.
Operators making use of this possibility will therefore access the market
faster, with reduced breeding costs and with varieties that up to now
were restricted from the market since it was not possible to register
varieties not meeting the DUS requirements.
A few dozen operators across EU are likely to use this option. The
number of varieties registered under these rules could be in average 100
annually. Assuming EUR 50 000 savings in breeding costs per variety,
concerned operators may see savings of EUR 5 million annually.
The rules for conservation
varieties are lighter and
extended to cover new
locally adapted varieties
Increased availability of conservation and locally adapted This measure creates a new market segment. Operators would benefit 0
varieties. Not monetised.
from lighter procedures for access to market (no DUS/VSCU
requirements for variety registration and no certification of PRM). The
number of operators concerned could be in the range of several
hundreds. The number of varieties marketed under these rules could be a
few hundred annually. However, the quantities of PRM concerned are
expected to remain limited below 2% of the market. Potential value
could be up to EUR 13.3 billion /year * 2%= EUR 266 million/year.
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The scope for
heterogeneous material is
broadened beyond organic
production
Increased availability of heterogeneous material. Not This measure creates a new market segment. Operators would benefit 0
monetised.
from lighter procedures for access to market. Number of operators and
quantities of PRM concerned are unknown. Though number of operators
could be in the range of several hundreds. Several hundred or few
thousand heterogeneous material are expected to be brought in the
market over the next ten years but the quantities of PRM concerned are
expected to be very limited and of insignificant market value.
N/A
0
0
The current simple regime
for ornamental plants is
maintained unchanged
Measures
common to
all options
for FRM
legislation
The decisions on the
N/A
equivalence to EU rules for
third countries will be
taken by means of tertiary
legislation.
The existing empowerment
to define the information to
be made available to
users/buyers of FRM is
extended to explicitly
cover suitability of FRM
for climatic and ecological
conditions.
N/A
N/A
Users of FRM will benefit from improved information as N/A
regards the suitability of FRM for climatic and ecological
conditions. As a result they will be able to select the most
appropriate FRM and reduce economic damage caused by
the use of unsuitable FRM. This is however not
quantifiable.
N/A
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8.3.
Overview of costs
Measures
Costs per option
Option 1
PRM/FRM users
Operators
NCAs
PRM/FRM users
Option 2
Operators
NCAs
PRM/FRM
users
Option 3
Operators
NCAs
Common
elements for
PRM
and
FRM:
Innovative
production
processes, BMTs
and digitalisation
Adoption of guidelines on innovative production processes, Introduction of basic rules on innovative production processes, Introduction of detailed rules on innovative production processes, BMTs
BMTs and digitalisation
BMTs and digitalisation and creation of empowerments for and digitalisation
detailing rules according to new developments
N/A
The measure provides new options N/A
and not new obligations. Therefore,
there are no costs imposed. Use of
new options however may require
investments in equipment and/or
staff. Any investment is expected to
be recovered within few years due to
efficiency gains and lower costs of
operations.
The measure provides new options and not N/A
new obligations. Therefore, there are no
costs imposed. Use of new options
however may require investments in
equipment and/or staff. Any investment is
expected to be recovered within few years
due to efficiency gains and lower costs of
operations.
Harmonisation of OCs on production, marketing and
imports of PRM/FRM subject to the OCR
Simplified import controls at appropriate places
Modified rate of OCs
(increase or decrease)
depending on current
situation per MS and
individual profile of
each
operator.
Globally
neutral
impact.
Reallocation of
resources,
depending
on
current
organisation.
Marginal costs
for compiling a
Multi-annual
national control
plan and an
annual report on
OCs.
Globally neutral
impact.
N/A
The measure provides new options and not new
obligations. Therefore, there are no costs imposed.
Use of new options however may require
investments in equipment and/or staff. Any
investment is expected to be recovered within few
years due to efficiency gains and lower costs of
operations.
Official controls
Harmonisation of OCs on production, marketing and imports
of PRM/FRM without links to OCR
N/A
Modified rate of
OCs (increase or
decrease) depending
on current situation
per
MS
and
individual profile of
each
operator.
Globally
neutral
impact.
Reallocation
of resources,
depending
on
current
organisation.
Marginal
costs
for
compiling a
Multi-annual
national
control plan
and
an
annual report
on OCs.
Globally
N/A
Harmonisation of OCs on production, marketing and imports of
PRM/FRM subject to the OCR
Stricter import controls at border control posts (BCPs) requiring
special import documentation
In comparison to
options 1 and 2, the
requirement
of
special
import
documentation will
result in significant
costs for operators
(not quantifiable).
In comparison to options 1
and 2, the requirement of
carrying out import controls
at BCPs will result in
significant costs for NCAs.
There are about 500 BCPs
designated for phytosanitary
controls. Assuming that these
would be the BCPs also for
PRM/FRM, they would need
to be equipped by staff to
carry out sampling of
imported PRM/FRM. With 1
person in average by BCP at
EUR 30 000 for salary, the
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neutral
impact.
For
PRM Assessment of
legislation
new varieties for
only
characteristics
contributing to
sustainable
production
The sustainability considerations in the examination of new
varieties are strengthened.
The current VCU examination for agricultural plant species
and vine is extended to include additional characteristics that
contribute to sustainable production in order to better steer
breeding efforts in this direction.
The new examination will be called Value for sustainable
cultivation and use (VSCU). It will also apply to new varieties
of the other crop groups (fruit plants and vegetables).
MS will have flexibility to implement VSCU according to
their agro-ecological conditions.
It will be possible for operators to conduct the VSCU
examination under official supervision.
MS will be able to collaborate and accept results from
For other crop groups (fruit plants and vegetables), the
MS with similar agro-ecological conditions, and/or create
assessment will rely on information that applicants
shared testing networks.
voluntarily submit along with the application for registration
An empowerment will be created to determine the
of a new variety
minimum requirements for carrying out the VSCU
examination and the accepted methodologies for
assessing the individual VSCU characteristics.
For organic varieties suitable for organic production, it
will be required that the VSCU examination is carried out
under conditions adapted to the specific needs of organic
production.
EUR 133 million
annually in increased
PRM
costs
for
farmers
Increased
registration costs
for the PRM sector
by EUR 2.45
million annually.
Marginal costs for
FRM.
Insignificant
costs
as
NCAs
are
not required
to increase
significantly
their
capacity.
EUR 400 million
annually
in
increased
PRM
costs for farmers.
Increased
registration costs for
the PRM sector by
EUR 6.40 million
annually. (PRM)
Marginal costs for
FRM.
EUR 43 to 98
million annually
The sustainability considerations in the examination of new
varieties are strengthened.
The current VCU examination for agricultural plant species
and vine is extended to include additional characteristics that
contribute to sustainable production in order to better steer
breeding efforts in this direction. The new examination will
be called Value for sustainable cultivation and use (VSCU).
For organic varieties suitable for organic production, it
will be required that the VSCU examination is carried
out under conditions adapted to the specific needs of
organic production.
MS will have flexibility to implement VSCU according
to their agro-ecological conditions.
total annual cost for NCAs
amounts to EUR 15 million.
The sustainability considerations in the examination of new varieties are
strengthened.
The current VCU examination for agricultural plant species and vine is
extended to include additional characteristics that contribute to
sustainable production in order to better steer breeding efforts in this
direction. The new examination will be called Value for sustainable
cultivation and use (VSCU). It will also apply to new varieties of the
other crop groups (fruit plants and vegetables).
In contrast to option 2:
Implementation of the VSCU will be harmonised between the MS.
Detailed rules on accepted methodologies for assessing the
individual VSCU characteristics will be introduced.
As under option 2:
It will be possible for operators to conduct the VSCU examination
under official supervision.
MS will be able to collaborate and accept results from MS with
similar agro-ecological conditions, and/or create shared testing
networks.
For organic varieties suitable for organic production, it will be
required that the VSCU examination is carried out under
conditions adapted to the specific needs of organic production.
EUR
667
million annually
in
increased
PRM costs for
farmers.
Increased
registration costs for
the PRM sector by
EUR 7.95 million
annually. Marginal
costs for FRM.
EUR 43 to 98 million
annually
Seed
conservation
networks,
marketing to
amateur
gardeners and
Exemption from the scope of the legislation of activities of Subject activities of seed conservation networks, marketing to Subject activities of seed conservation networks, marketing to amateur
seed conservation networks, marketing to amateur gardeners amateur gardeners and exchange in kind of seeds between gardeners and exchange in kind of seeds between farmers to the general
and exchange in kind of seeds between farmers
farmers to lighter rules
requirements of the legislation
N/A
0
[No
new
Negligible
costs
N/A
0
[New
opportunities
Negligible costs
[Some training
N/A
0
[No
change
in
0
[No change in relation to
110
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exchange in kind
of seeds between
farmers
obligations]
[Some
training of
staff may be
required in
order to tell
apart PRM
exempted
from
legislation]
but of insignificant
market value. No new
obligations.]
of staff may be
required in order
to implement the
new rules.]
relation to current
situation]
current situation]
For
FRM Scope of FRM
legislation
the legislation
only
Define forestry and non-forestry purposes but maintain Define forestry and non-forestry purposes and extend scope of Define forestry and non-forestry purposes and extend scope of FRM
current scope of FRM legislation
FRM legislation to include the production of FRM for specific legislation to include the production of FRM for specific non-forestry
non-forestry purposes
purposes
N/A
0
[Depending
on
current definitions
used by MS, some
uses may be added
or removed from the
scope,
overall
neutral impact in
certification costs
for operators]
0
[Depending
on
current
definitions
used by MS,
some
uses
may
be
added
or
removed
from
the
scope,
overall
neutral
impact
in
enforcement
costs
for
NCAs]
N/A
0
[Increased costs as
FRM for non-forestry
purposes will become
subject to testing costs
(certification)
but
limited as it concerns
10% of FRM]
0
[Increased costs
as FRM for non-
forestry
purposes
will
become subject
to certification
but limited as it
concerns 10% of
FRM]
N/A
0
[Increased costs as
FRM
for
non-
forestry
purposes
will become subject
to testing costs
(certification)
but
limited
as
it
concerns 10% of
FRM]
0
[Increased costs as FRM for
non-forestry purposes will
become
subject
to
certification but limited as it
concerns 10% of FRM]
Assessment of
FRM for
characteristics
contributing to
sustainable
production
Extend sustainability requirements to cover lower FRM
categories
Adopt guidelines on sustainability requirements for all
FRM categories
Extend sustainability requirements to cover lower FRM
categories
Introduce general principles on sustainability
requirements for all FRM categories with flexibility for
MS to implement according to their environmental
conditions
Extend sustainability requirements to cover lower FRM categories
Introduce detailed and harmonised rules on sustainability
requirements for all FRM categories
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N/A
0
[Negligible increase
of costs]
0
[Negligible
increase of
costs]
N/A
0
[Negligible
of costs]
increase
0
[Negligible
increase
costs]
N/A
of
0
[Negligible increase
of costs]
0
[Negligible increase of costs]
Address
difficulties in
supply of suitable
FRM
N/A
Maintain the existing empowerment to authorise MS to
use FRM not fulfilling all requirements when there are
difficulties in supply
Adopt guidelines on contingency planning to ensure
availability of FRM
0
[Negligible increase
of costs]
0
[Negligible
increase of
costs]
N/A
Maintain the existing empowerment to authorise MS to
use FRM not fulfilling all requirements when there are
difficulties in supply
Introduce a general requirement for contingency planning
in the MS to ensure availability of FRM
0
[Negligible
of costs]
increase
0
[Negligible
increase
costs]
N/A
of
Maintain the existing empowerment to authorise MS to use FRM
not fulfilling all requirements when there are difficulties in supply
Introduce common rules on contingency planning in the MS to
ensure availability of FRM
0
[Negligible increase
of costs]
0
[Negligible increase of costs]
Conservation and Adoption of guidelines for the registration of basic material
sustainable use of for the purposes of conservation of forest genetic resources
forest genetic
resources
N/A
0
0
[Negligible increase [Negligible
of costs]
increase of
costs]
Introduction of a derogation for the registration of basic Introduction of a derogation for the registration of basic material for the
material for the purposes of conservation of forest genetic purposes of conservation of forest genetic resources
resources
N/A
0
[Negligible
of costs]
increase
0
[Negligible
increase
costs]
N/A
of
0
[Negligible increase
of costs]
0
[Negligible increase of costs]
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8.4.
Overview of benefits
Measures
Benefits per option
Option 1
PRM/FRM
users
Operators
NCAs
PRM/FRM
users
Option 2
Operators
NCAs
PRM/FRM users
Option 3
Operators
NCAs
Common
Innovative production Adoption of guidelines on innovative production
elements for processes, BMTs and processes, BMTs and digitalisation
PRM
and digitalisation
FRM:
N/A
The measure provides new options and
not new obligations. Therefore, there
are no direct benefits. Use of new
options
however
may
require
investments in equipment and/or staff.
Any investment is expected to be
recovered within few years due to
efficiency gains and lower costs of
operations.
Official controls
Introduction of basic rules on innovative production processes, Introduction of detailed rules on innovative production processes, BMTs and
BMTs and digitalisation and creation of empowerments for digitalisation
detailing rules according to new developments
N/A
The measure provides new options and not N/A
new obligations. Therefore, there are no
direct benefits. Use of new options however
may require investments in equipment
and/or staff. Any investment is expected to
be recovered within few years due to
efficiency gains and lower costs of
operations.
Harmonisation of OCs on production, marketing and
imports of PRM/FRM subject to the OCR
Simplified import controls at appropriate places
Efficiency gains (not monetised)
Extension of the current VCU requirements for
agricultural plant species and vine to better address
sustainability
Introduction of these requirements for all other crop
groups (vegetables and fruit plants)
Flexibility for MS to implement these requirements
according to their agro-ecological conditions
Permit examination of these requirements under official
supervision
Creation of empowerment to adopt rules on accepted
methodologies for assessing the different characteristics
N/A
The measure provides new options and not new
obligations. Therefore, there are no direct benefits.
Use of new options however may require investments
in equipment and/or staff. Any investment is expected
to be recovered within few years due to efficiency
gains and lower costs of operations.
Harmonisation of OCs on production, marketing and
imports of PRM/FRM without links to OCR
N/A
Efficiency gains (not monetised)
N/A
Harmonisation of OCs on production, marketing and imports of
PRM/FRM subject to the OCR
Stricter import controls at border controls requiring special import
documentation
Efficiency gains (not monetised)
Extension of the current VCU requirements for agricultural plant
species and vine to better address sustainability
Introduction of these requirements for all other crop groups
(vegetables and fruit plants)
Harmonised implementation of these requirements.
Permit examination of these requirements under official supervision
Introduction of detailed rules on accepted methodologies for assessing
the different characteristics
For
PRM Assessment of new
legislation
varieties for
only
characteristics
contributing to
sustainable production
Extension of the current VCU requirements for
agricultural plant species and vine to better
address sustainability
For all other species, reliance on information that
applicants voluntarily submit along with the
application for registration of a new variety
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EUR 310 to 1
243 million
annually in
terms
of
avoided loss
in
crop
output.
Reduced
losses
in
forestry (not
monetised).
Seed conservation
networks, marketing
to amateur gardeners
and exchange in kind
of seeds between
farmers
N/A
N/A
EUR 621 to 2
486
million
annually
in
terms of avoided
loss in crop
output.
Reduced losses
in forestry (not
monetised).
N/A
N/A
EUR 466 to 1 864
million annually
in
terms
of
avoided loss in
crop output.
Reduced losses in
forestry
(not
monetised).
N/A
N/A
Exemption from the scope of the legislation of Subject activities of seed conservation networks, marketing to Subject activities of seed conservation networks, marketing to amateur
activities of seed conservation networks, marketing to amateur gardeners and exchange in kind of seeds between gardeners and exchange in kind of seeds between farmers to the general
amateur gardeners and exchange in kind of seeds farmers to lighter rules
requirements of the legislation
between farmers
0
[New
opportunities
for
seed
conservation
networks and
for exchange
in kind of
seeds
between
farmers but
of
insignificant
market
value].
0
[New opportunities
in the market to
amateur gardeners
but of insignificant
market value].
N/A
0
[New
opportunities for
seed
conservation
networks and for
exchange
in
kind of seeds
between farmers
but
of
insignificant
market value].
0
[New opportunities in
the market to amateur
gardeners
but
of
insignificant market
value].
N/A
[No change in
relation to current
situation]
[No
change
in
relation to current
situation]
[No change in relation to
current situation]
For
FRM Scope of FRM the
legislation
legislation
only
Define forestry and non-forestry purposes but maintain Define forestry and non-forestry purposes and extend scope of Define forestry and non-forestry purposes and extend scope of FRM
current scope of FRM legislation
FRM legislation to include the production of FRM for specific legislation to include the production of FRM for specific non-forestry
non-forestry purposes
purposes
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N/A
0
0
Indirect
non- 0
monetary
benefits in terms
of
improved
quality of FRM
for non-forestry
purposes
0
Indirect
non-
monetary benefits
in
terms
of
improved quality
of FRM for non-
forestry purposes
0
0
Assessment of FRM
for characteristics
contributing to
sustainable production
Extend sustainability requirements to cover
lower FRM categories
Adopt guidelines on sustainability requirements
for all FRM categories
Extend sustainability requirements to cover lower FRM
categories
Introduce general principles on sustainability
requirements for all FRM categories with flexibility for
MS to implement according to their environmental
conditions
Extend sustainability requirements to cover lower FRM categories
Introduce detailed and harmonised rules on sustainability requirements
for all FRM categories
Indirect non- 0
monetary
benefits
in
terms
of
improved
quality
of
FRM for non-
forestry
purposes
Address difficulties in
supply of suitable
FRM
0
Indirect
non- 0
monetary
benefits in terms
of
improved
quality of FRM
for non-forestry
purposes
Indirect
non-
monetary benefits
in
terms
of
improved quality
of FRM for non-
forestry purposes
0
0
Maintain the existing empowerment to authorise
MS to use FRM not fulfilling all requirements
when there are difficulties in supply
Adopt guidelines on contingency planning to
ensure availability of FRM
0
Maintain the existing empowerment to authorise MS to
use FRM not fulfilling all requirements when there are
difficulties in supply
Introduce a general requirement for contingency planning
in the MS to ensure availability of FRM
0
Maintain the existing empowerment to authorise MS to use FRM not
fulfilling all requirements when there are difficulties in supply
Introduce common rules on contingency planning in the MS to ensure
availability of FRM
0
0
Indirect non- 0
monetary
benefits
in
terms
of
improved
availability of
FRM
Conservation and
sustainable use of
forest genetic
Indirect
non- 0
monetary
benefits in terms
of
improved
availability of
FRM
Indirect
non-
monetary benefits
in
terms
of
improved
availability
of
FRM
Adoption of guidelines for the registration of basic Introduction of a derogation for the registration of basic Introduction of a derogation for the registration of basic material for the
material for the purposes of conservation of forest material for the purposes of conservation of forest genetic purposes of conservation of forest genetic resources
genetic resources
resources
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resources
Indirect non- 0
monetary
benefits
in
terms
of
increased
genetic
diversity of
FRM
0
Indirect
non-
monetary
benefits in terms
of
increased
genetic diversity
of FRM
0
[Savings
due
to
reduction of costs but
insignificant
as
volumes
concerned
are very limited]
0
[Savings due to
reduction of costs
but insignificant as
volumes
concerned are very
limited]
Indirect
non-
monetary benefits
in
terms
of
increased genetic
diversity of FRM
0
[Savings due to
reduction of costs
but insignificant as
volumes concerned
are very limited]
0
[Savings due to reduction of
costs but insignificant as
volumes concerned are very
limited]
116
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8.5.
Net benefit and cost benefit analysis
Global costs and benefits per option (excluding common measures)
Option 1
PRM/FRM users
Costs per stakeholder category
(million EUR/year)
Global costs (million EUR/year)
Benefits per stakeholder category
(million EUR/year)
Global benefits (million
EUR/year)
from 310 to 1 243
133
135
0
from 310 to 1 243
0
from 621 to 2 486
Operators
2
NCAs
0
PRM/FRM users
400
Option 2
Operators
6
from 449 to 504
0
from 621 to 2 486
0
from 466 to 1 864
NCAs
from 43 to 98
PRM/FRM users
667
Option 3
Operators
8
from 733 to 788
0
from 466 to 1 864
0
NCAs
from 58 to 113
Cost benefit analysis of options under the best scenario (highest benefits and lowest costs)
Net benefit (million EUR/year)
Benefit Cost Ratio
1 243 – 135 = 1 108
1 243 / 135 = 9.20
2 486 – 449 = 2 037
2 486 / 449 = 5.53
1 864 - 733= 1 131
1 864 / 733 = 2.54
Cost benefit analysis of options under the worst scenario (lowest benefits and highest costs)
Net benefit (million EUR / year)
Benefit Cost Ratio
310 – 135 = 175
310 / 135 = 2.29
621 – 504 = 117
621 / 504 = 1.23
466 - 788 =
- 322
466 / 788 = 0.59
117
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9.
R
EDUCTION
OF ADMINISTRATIVE BURDENS DUE TO SIMPLIFICATION OF ADMINISTRATIVE
PROCEDURES
All professional operators to be registered in a single register under the PHL
Over 20 000 duplicate registrations will be avoided and over EUR 800 000 annual savings in
registration costs for operators supplying PRM of fruit plants. Over 4 000 duplicate registrations
will be avoided and there will be over EUR 237 000 annual savings in registration costs for
operators supplying FRM.
There will be marginal savings for the NCAs due to the fact that there will be no obligation to keep
separate registers of professional operators under PRM/FRM legislation and PHL.
Decisions for addition of new species in (or removal of species from) the scope of the
PRM legislation will be taken by means of tertiary legislation.
Decisions on the equivalence to EU rules for third countries will be taken by means of
tertiary legislation.
Currently decision making by means of tertiary legislation is already the case for some marketing
Directives for both the regulated species and the equivalence for third countries. However, some
Directives require that for such decisions the ordinary legislative procedure is followed, which is
cumbersome and disproportionate compared to the technical nature of the matter.
These measures will result in
no costs for NCAs or operators,
while there will be benefits for the
Commission, the NCAs and operators in terms of
reduced hassle costs
due to shorter time to reach
decisions (not monetised as per the Better Regulation guidelines). Any benefits are expected to be
negligible in the short term as since the adoption of the first Directives, there have been very few
changes in the lists of regulated species and about 1 or 2 requests from third countries per year are
examined for equivalence. In the mid- to long-term however it is expected that shorter time to reach
decisions would be beneficial in the light of rapidly changing conditions in relation to food security.
The transfer/notification of new varieties from national to Common Catalogues will be
managed by the MS without the need for a Commission Decision.
On the basis of notifications received from MS, the Commission publishes in the Official Journal of
the European Communities under the titles ‘Common Catalogue of Varieties of Agricultural Plant
Species’ and ‘Common Catalogue of Varieties of Vegetables Species’ lists of all the varieties of
which the seed and propagating material can be marketed throughout the EU. The publication of the
supplements to the Common Catalogues requires a Commission Decision. Currently the
Commission adopts every year 12 Decisions for the agricultural plant species (in average 2564
varieties every year) and 12 Decisions for the vegetable species (on average 1384 varieties per
year). This procedure creates unnecessary waiting time until a variety is included in the Common
Catalogues and gets access to the common market.
The measure will result in
no costs for NCAs or operators,
while there will be benefits for the
Commission in terms of
removing the need for 24 Decisions annually
and operators in terms of
reduced hassle costs
(not monetised as per the Better Regulation guidelines). Depending on the
current practices of the MS,
the period between acceptance in a national catalogue of new
118
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varieties of agricultural plant species and vegetable species and access to the common market
will be shortened by 1 to 4 months.
Allow MS to decide themselves on permitting temporarily the marketing of seed that
does not satisfy the requirements in respect of minimum germination, if germination is
not lower than 15 % than the required germination rate.
Currently MS wishing to use this derogation have to inform the Commission and the other MS who
can make an offer to cover the missing supply. If no offers are received, the MS are authorised to
allow the marketing of seed with lower germination rate by a Commission Decision. This
procedure is disproportionate as most often there are no suitable offers, while the quantities
concerned are limited (in average 50 000 tonnes of seed annually, or about 0.01% of the quantities
of seed certified annually). Over the last five years only 5 to 12% of the requested amounts could
be covered by seed offered by other MS. For the remaining requests, an authorisation was granted
after the period for other MS to submit offers had expired. Around 85% of the requests concern
germination 15% or less below the minimum germination as laid down in the seed marketing
Directives.
The measure will result in
no costs for NCAs or operators.
There will be
benefits for the
Commission and the NCAs in avoiding the handling of in average 30 notifications per year.
There will also be
benefits for operators in terms of reduced hassle costs
due to shorter time (at
least by 15 days for each avoided notification, not monetised) to cover the market needs when seed
satisfying the minimum germination requirements is not available. The flexibility introduced by
this measure is expected to gain importance in the mid- to long-term since problems of reduced
germination are expected to occur more often under extreme conditions due to climate change.
119
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A
NNEX
5: B
ACKGROUND INFORMATION
1.
T
HE
PRM
LEGISLATION AND ITS DEVELOPMENT
The PRM Directives have been in force since the mid-1960s. The legislative framework comprises
one horizontal Directive on the Common Catalogue of Varieties and 11 vertical Directives dealing
with specific plant groups:
1. Council Directive 2002/53/EC on the common catalogue of varieties of agricultural plant
species (http://data.europa.eu/eli/dir/2002/53/2004-04-18)
2. Council Directive 66/401/EEC on the marketing of fodder plant seed
(http://data.europa.eu/eli/dir/1966/401/2020-02-16)
3. Council
Directive
66/402/EEC
on
the
marketing
of
cereal
seed
(http://data.europa.eu/eli/dir/1966/402/2020-02-16)
4. Council
Directive
2002/54/EC
on
the
marketing
of
beet
seed
(http://data.europa.eu/eli/dir/2002/54/2017-04-01)
5. Council
Directive
2002/55/EC
on
the
marketing
of
vegetable
seed
(http://data.europa.eu/eli/dir/2002/55/2020-07-01)
6. Council
Directive
2002/56/EC
on
the
marketing
of
seed
potatoes
(http://data.europa.eu/eli/dir/2002/56/2020-02-16)
7. Council Directive 2002/57/EC on the marketing of seed of oil and fibre plants
(http://data.europa.eu/eli/dir/2002/57/2020-02-16)
8. Council Directive 68/193/EEC on the marketing of material for the vegetative propagation
of the vine (http://data.europa.eu/eli/dir/1968/193/2020-02-16)
9. Council Directive 1998/56/EC on the marketing of propagating material of ornamental
plants (http://data.europa.eu/eli/dir/1998/56/2014-06-30)
10. Council Directive 2008/72/EC on the marketing of vegetable propagating and planting
material, other than seed (http://data.europa.eu/eli/dir/2008/72/2020-07-01)
11. Council Directive 2008/90/EC on the marketing of fruit plant propagating material and fruit
plants intended for fruit production (http://data.europa.eu/eli/dir/2008/90/2019-01-28)
12. Council Directive 1999/105/EC on the marketing of forest reproductive material
(http://data.europa.eu/eli/dir/1999/105/oj)
The majority of Council Directives for the marketing of PRM were adopted between 1966 and
1971. Some Directives are more recent, such as the Council Directive for the marketing of
vegetable propagating material and planting material other than seed and the one for the marketing
of ornamentals. These Directives have been updated both frequently and substantially. The original
Directives on fodder plant seed and cereal seed are still in force although these have been subject to
a large number of amendments. The SLIM initiative launched by the Commission in 1996 has led
to the recasting of the Council Directive on the marketing of ornamental plants in 1998 as well as to
the ‘2002’ Directives (2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, and 2002/57/EC) that
are codifications of pre-existing Directives. Directives 66/401/EEC and 66/402/EEC were not
included in this SLIM initiative as some amendments were on-going at the time when the
Directives were recast or codified. As a follow-up to the Organisation for Economic Co-operation
120
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and Development (OECD) revision of its trade scheme for FRM in the mid-1990s, the EU
undertook to renew its old Directive so that there would be only one set of definitions and rules for
marketing of FRM. The new Directive 1999/105/EC has standards that reflect the increase in MS
since 1966, for example in the number of species covered. A more recent change was the adoption
of Council Directive 2008/90/EC, a recast of Council Directive 92/34/EEC
216
on the marketing of
fruit plant propagating material and fruit plants intended for fruit production.
Figure 4. Overview of marketing Directives and corresponding Common Catalogues
2.
P
RINCIPLES OF THE
PRM
LEGISLATION
2.1.
Variety registration
2.1.1.
Distinctness, uniformity and stability (DUS)
For the purposes of variety registration (‘first pillar’, Figure 5), the NCAs of the MS test by field
trials the candidate new plant varieties for their DUS). The characteristics (e.g. shape and
morphology of the leaves) of the candidate varieties are compared with those of several existing
plant varieties in the EU (‘reference varieties’). New varieties need to be different from reference
varieties (distinctness requirement). The characteristics of different plants within the same variety
should be similar (uniformity requirement). The characteristics of the plants of a new variety should
not change over time (stability requirement). DUS tests take about two years in the case of varieties
of agricultural and vegetable species and 5-6 years in the case of varieties of fruit plants and vine.
Upon completion of the DUS tests, varieties of vegetable species and fruit plants are registered in
the national catalogue of the MS concerned and subsequently submitted to the corresponding EU
Common Catalogue. Each registered plant variety has a denomination, i.e. a name that serves to
identify that variety
217
. PRM is always marketed with reference to a plant variety whereby the
variety denomination is displayed on the official label/operator’s label.
216
217
OJ L 157, 10.6.1992, p. 10.
An example of a denomination of an apple variety is Boskoop Rouge Bakker.
121
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2.1.2.
Value for cultivation and use (VCU)
In addition to the DUS test, varieties of agricultural species need to be assessed for their VCU
before they can be registered. Through comparative field trials in distinct locations across the
country, the NCAs compare the performance of new plant varieties as regards four characteristics
with that of varieties in their national catalogues (Figure 5). The value of a variety for cultivation or
use shall be regarded as satisfactory if, compared to other varieties accepted in the catalogue of the
MS concerned, its qualities, taken as a whole, offer, at least as far as production in any given region
is concerned, a clear improvement either for cultivation or as regards the uses which can be made of
the crops or the products derived therefrom. Where other, superior characteristics are present,
individual inferior characteristics may be disregarded
218
. Varieties of agricultural species are
registered in the national catalogue upon completion of the DUS and VCU examinations.
New varieties of vine undergo a test similar to VCU pursuant to Commission Directive
2004/29/EC
219
. This VCU-like test forms part of the examination of the physiological
characteristics of vine varieties carried out in the frame of the DUS test. Through field trials NCAs
assess new vine varieties for yield, use, sensitivity/resistance to unfavourable conditions and pests.
Commission Directive 2004/29/EC does not explicitly refer to VCU, but it contains requirements
similar to the VCU criteria of agricultural species. MS have diverged in their implementation of the
legislation. In France, the VCU examination forms part of the registration procedure of new vine
varieties. There is a technical examination document (‘règlement technique’) for new varieties that
is directly linked to Directive 2004/29. Italy modified the legislation 5 years ago. The
characteristics to be assessed under the new Italian Decree no longer refer to Directive 2004/29. In
total, 75 characteristics stemming from the CPVO protocol for the DUS examination of vine
varieties need to be assessed
220
and the Descriptor list of grape varieties and
Vitis
species of the
International Organisation of Vine and Wine (OIV)
221
.
The VCU examinations of plant varieties are based on phenotypic observation of the crop in the
field according to the relevant protocols. DUS protocols are common for all MS while VCU
protocols are defined by each MS. The use of BMTs is gaining more importance as a
supplementary tool to phenotypic observations in the field (this Annex, Section 7).
218
Depending on the regional conditions, the priorities could be different. For example, slightly lower yield can be
accepted if the new variety is found to be tolerant to drought.
219
OJ L 71, 10.3.2004, p. 22.
220
CPVO-TP/050/2.
221
https://www.oiv.int/public/medias/2274/code-2e-edition-finale.pdf
122
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Figure 5. Pillars of the PRM legislation
1
Applies to agricultural and vegetable species, fruit plants and vine
2
Applies to agricultural species and vine
3
During certification the identity, quality and health of PRM is checked
Decreasing requirements for PRM means lower PRM quality and lower market value
of PRM
In the current legislation on fruit plants, vegetable seed and vegetable propagating material other
than seed it is not mandatory to carry out a VCU examination as part of the variety registration
process. Recital (3) to Council Directive 2008/90/EC
222
states that ‘Satisfactory
results in the
cultivation of fruit depend to a large extent on the quality and plant health of the material used for
their propagation and of the fruit plants intended for fruit production.’
Recital (9) refers to the
establishment of plant health and quality standards for each genus and species of fruit plant based
on international schemes. Furthermore, it states that ‘it
is appropriate to provide, therefore, for a
for a system of harmonised rules for the different categories of propagating material and fruit
plants to be marketed by reference to those international schemes, where available’.
In the absence
of mandatory common rules on VCU testing, MS have diverged in their implementation of the
legislation.
Poland has 5 testing stations to examine new varieties of fruit plants (apples, pears, plums, cherries,
peaches, apricots, currants). Through comparative field experiments new varieties are evaluated for:
-
-
-
-
-
susceptibility to diseases and pests;
high nutritional value of fruit suitable for consumption;
storage capacity;
resistance to frost and susceptibility of flowers to spring frost;
possibility of machine harvesting of fruit.
Until 1997, Czechia assessed the VCU of apples, pears, plums, cherries, apricots, small fruits under
various climatic conditions in accordance with the VCU examination conducted for agricultural
222
OJ L 267, 8.10.2008, p. 8.
123
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crops. VCU trials were stopped because of the high costs and the time-demanding process. Since
1997, informal VCU trials are carried out by universities, research institutes and private growers.
Nowadays, subsidies are given for:
-
varieties intended for integrated production based on growing characteristics (disease
resistance, fruit quality, frost hardiness and stability of yields);
-
varieties for organic production recommended by breeders, research institutions, growers’
associations and non-governmental institutions based on their experience.
Efforts are undertaken to assess sustainability characteristics of new varieties of fruit plants. The
European fruit research institutes network (eufrin)
223
is an informal, voluntary organisation of
university departments and research institutes. They specialise in research, development, and
extension on temperate fruit crops and are based within countries of the EU, Switzerland, and
Eastern Europe. They organise working groups on variety testing of new varieties of fruit plants
with a proven unified descriptor list in a wide range of climatic conditions.
In the vegetable seed and vegetable propagating material sector there is a high turnover of varieties
because there is a high number of vegetable varieties in the EU Plant Variety Portal (± 22 000
vegetable varieties). Each year, about 1 400 new varieties are registered. There is a large diversity
of cultivation systems:
a)
b)
c)
d)
spring/summer/autumn crops;
indoor/outdoor cultivation;
type of medium, mechanisation and irrigation systems;
type of crop protection (hygiene, seed treatment, chemical, natural enemies,…).
A major part of vegetables is marketed as harvested fresh produce via retailers to consumers and a
minor part as vegetable seed. There are different uses of the harvested products. Tomato can be
used for direct consumption in a salad, for pasta sauces or ketchup. Consumer preferences as
regards colour, size, flavour play an important role in the breeding and selection process of new
vegetable varieties. It is very complicated to design harmonised VCU examinations for vegetable
varieties because of the different cultivation systems, the different uses of vegetable seed and
propagating material and the need to consider consumer preferences. For this reason, there is
currently no official VCU examination but there is a direct interaction between the seed company
and the farmer to check the performance of new vegetable varieties in relation to existing varieties.
2.2.
Certification
2.2.1.
Official certification
Certification of PRM (‘second pillar’, Figure 5) consists of checking the identity, quality, and
health of PRM during the growing (= production) of that material in the field. Seeds are sampled
and tested in relation to the respective technical requirements and finally the variety identity and
purity is controlled by control-plot tests. The identity check serves to verify that the PRM has the
same characteristics as the registered plant variety to which that PRM belongs. The quality of the
223
https://eufrin.eu/frontpage
124
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PRM relates to the absence of defects or the shape of the plants
224
. Depending on the quality,
different marketing categories of PRM are defined. The NCAs perform regular checks during the
production of PRM to verify that it does not contain any plant pests or diseases. Upon completion
of all these inspections the NCAs issue an official label. That label confirms that the PRM is
officially certified and that it can be marketed throughout the EU. The PRM legislation also
includes rules for marketing of PRM in homogeneous lots that assure traceability and rules for
packaging, sealing, labelling and documentation.
2.2.2.
Certification under official supervision
The PRM legislation permits the transfer of aspects of the certification procedures to industry
through a system of certification under official supervision (Figure 6). Operators and staff
(company inspector, company sampler) involved in these activities can be authorised if they follow
a mandatory training course given by the NCAs and are licensed. They can then perform field
inspections to check the identity, quality and health of PRM in the production site. The NCAs
perform official check testing on at least 5% of the field inspections performed by the company
inspectors to verify that the field inspections have been carried out in a proper way. Furthermore,
operators can carry out seed sampling and testing and be authorised to print official labels. The
NCAs carry out official inspections on those operators (5% of which is officially check-tested) and
their staff on a regular basis to ensure that they perform these tasks in a correct way. NCAs always
perform pre- and post-control testing, take the decision on the certification of the PRM and
authorise the issuing of the official labels. For each of the aforementioned activities the operator
can apply for authorisation to carry out that activity under official supervision. For example, the
NCA performs official field inspections while the operator carries out seed sampling and testing
under official supervision of the NCA. This flexibility as regards the distribution of activities
performed officially by the NCAs or by the operator under official supervision is called the mix and
match approach. Certification under official supervision is currently allowed only for certified seed
of agricultural species
225
but not for seed potatoes. The PRM legislation and the Rules and
Regulations of the OECD Seed Schemes are aligned as regards the conditions for certification
under official supervision
226
.
224
In the case of fruit trees, the trees concerned should have a main stem with a number of side branches in a
symmetrical form to ease mechanical harvesting.
225
Directives 66/401/EEC, 66/402/EEC, 2002/54/EC and 2002/57/EC.
226
OECD Seed Schemes Rules and Regulations 2022.
125
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Figure 6. Official certification and certification under official supervision
2.3.
Activities of seed conservation networks and exchange in kind
Seed conservation networks are involved in the conservation and sustainable use of plant genetic
resources. In practice this means that they conserve seeds. This can be done in a seed bank (i.e.
seeds stored under cooled conditions) or in a live collection (seeds grown in a field). Seed
conservation networks exchange seed with other networks to grow it under other climatic
conditions or better characterise it.
Exchange in kind means the not-for-profit transfer of seeds from one farmer to another farmer. In
most marketing Directives this transfer is considered to be marketing. For example, Article 2(1)
point (a) of Council Directive 2002/55/EC
227
on the marketing of vegetable seed states the
following: ‘marketing:
shall mean the sale, holding with a view to sale, offer for sale and any
disposal, supply or transfer aimed at commercial exploitation of seed to third parties, whether or
not for consideration’.
This means that seed exchanged in kind has to be authorised for marketing.
The variety to which that seed belongs has to be officially registered in one of the national
catalogues and the seed has to be certified. As mentioned in Section 2.1.2. those varieties often do
not meet the variety registration requirements (DUS test) as they are not sufficiently uniform or the
available seed quantity is too low to allow its proper characterisation. In the latter case of low seed
quantities, all available seed would have been used upon completion of the variety registration and
seed certification.
In most MS exchange in kind of seeds between farmers is not permitted. A couple of MS (Austria
and France) have allowed exchange in kind of seeds between farmers under specific
circumstances
228
. In France, under Article 315-5 of the Code Rural, exchange in kind of seeds and
other PRM is permitted in the context of a ‘mutual assistance’ framework, as long as they do not
belong to a variety protected by a plant variety right, they are not produced within the framework of
227
228
OJ L 193, 20.7.2002, p. 33.
ICF(2023), Section 5.1.2.1.
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a multiplication contract, and are not intended for commercialisation
229
. In Austria
230
the “exchange
of seeds for the protection of plant genetic resources between farmers and seed users” is exempted
from the scope of the legislation under the following conditions (1) the farmer or seed user does not
deal in seed trade, (2) the variety to which the exchanged PRM belongs is not registered in the
Austrian national catalogue, the EU common catalogues or the OECD list for international seed
trade (except for conservation and amateur varieties) and (3) within species-specific quantitative
restrictions limiting the amounts that can be exchanged. In Italy, the national legislation was
amended in 2021 to allow for in-kind exchange between farmers of a portion of their harvest
231
.
The new legislation does not provide any detailed information regarding the conditions of
exchange, including quantities or varieties that can be exchanged.
At international level, the International Treaty on Plant Genetic Resources for Food and Agriculture
(ITPGRFA) recognises the rights of farmers “to save, use, exchange and sell farm-saved
seed/propagating material, subject to national law and as appropriate”
232
. The United Nations
Declaration on the Rights of Peasants and Other People Working in Rural Areas (UNDROP) also
recognises that “peasants and other people working in rural areas have the right to save, use,
exchange and sell their farm-saved seed or propagating material”
233
.
2.4.
Marketing to amateur gardeners
An amateur gardener means a person who engages in gardening as a hobby. A survey addressing
amateur gardeners showed three major reasons for being involved in amateur gardening
234
. First,
growing edible produce was an important reason for being involved in gardening. Second, amateur
gardeners garden for enjoyment (i.e. as a hobby). Third, they garden to improve or maintain the
appearance of their garden. These activities are outside the scope of the PRM legislation. For
example, amateur gardeners can exchange or sell to each other PRM without any restriction.
PRM that is intended for marketing to amateur gardeners has to be authorised for marketing
pursuant to the pillars of the PRM certification system (Figure 5). Consequently, the vast majority
of PRM marketed to amateur gardeners belongs to registered varieties. The derogatory rules for
acceptance of varieties and certification of seeds for agricultural and vegetable conservation
varieties (Section 2.1.2.) cannot meet the demand of an important share of amateur gardeners for
diverse and locally adapted varieties. Under the future legal framework, amateur gardeners will
have the possibility to choose between more genetically diverse and less uniform PRM on the one
hand and certified PRM on the other.
In 2020, France adopted a Regulation that excludes from the general PRM legislation the exclusive
marketing to amateur gardeners of PRM that belongs to varieties that are not or no longer subject to
intellectual property rights (i.e. plant variety rights)
235
. In practice this means that the varieties
229
230
https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000029585219/2014-10-15.
Saatgutgesetz 1997 (Austrian seed law 1997)
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10011033.
231
Decreto
legislativo
2
febbraio
2021,
n.20.
https://www.normattiva.it/uri-
res/N2Ls?urn:nir:stato:decreto.legislativo:2021;020
232
https://www.fao.org/plant-treaty/overview/en/.
233
https://digitallibrary.un.org/record/1650694.
234
ICF(2021).
235
LOI n° 2020-699 du 10 juin 2020.
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concerned do not have to be registered in the French national catalogue and that the PRM does not
have to be certified. The French Variety and Seed Study and Control Group (GEVES) further
clarified that the varieties of PRM that are marketed to both professional users and amateur
gardeners have to be registered in the French national catalogue
236
.
2.5.
Organic varieties suitable
heterogeneous material
for
organic
production
and
organic
Organic varieties suitable for organic production
According to the principles of the Organic Regulation, for the production of organic varieties
suitable for organic production, the organic breeding activities shall be conducted under organic
conditions and shall focus on enhancement of genetic diversity, reliance on natural reproductive
ability, as well as agronomic performance, disease resistance and adaptation to diverse local soil
and climate conditions. However, currently the biggest share of PRM for organic varieties marketed
in the EU are varieties accepted under the DUS rules (this Annex, Section 2.1)
237
. Those varieties
have a high degree of uniformity and this goes contrary to the aforementioned principle of
focussing on an enhancement of genetic diversity.
Organic heterogeneous material
The Organic Regulation
238
has defined ‘organic heterogeneous material’ but the term
‘heterogeneous material’ does not exist in the PRM legislation. Organic heterogeneous material is
characterised by a high level of genetic and phenotypic diversity between individual reproductive
units. It is not a variety nor is it a mixture of varieties. The Organic Regulation allows the
marketing of organic heterogeneous material without complying with the requirements for
registration and without complying with the certification categories of pre-basic, basic and certified
material or with the quality, health and identity requirements for
Conformitas Agraria
Communitatis
(CAC), standard or commercial categories, set out in the PRM legislation. This
derogation from the PRM legislation for organic heterogeneous material has responded to the
demand for more genetically diverse PRM. The production of this type of material is restricted to
certified organic producers.
2.6.
Conservation varieties
For decades since the introduction of the first seed marketing directives, only DUS varieties were
allowed to be marketed. As the questions of biodiversity and the conservation of plant genetic
resources grew in importance, derogations to the rules for acceptance of varieties and certification
of seeds were adopted for agricultural and vegetable landraces in 2008
239
and 2009
240
respectively
(termed as ‘conservation varieties’). Derogations were also introduced in 2010 for marketing fodder
236
https://www.geves.fr/actualites/suppression-de-lobligation-dinscription-au-catalogue-officiel-francais-des-varietes-
du-domaine-public-pour-les-amateurs%E2%80%AF-quen-est-il-
precisement%E2%80%AF/#:~:text=La%20loi%20n%C2%B0%202020,Catalogue%20officiel%2C%20fran%C3%A7ai
s%20ou%20europ%C3%A9en
237
Euroseeds (2019).
238
Regulation (EU) 2018/848 and Commission Delegated Regulation (EU) 2021/1189.
239
Commission Directive 2008/62/EC
240
Commission Directive 2009/145/EC
128
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plant mixtures for use in preservation of the environment
241
. Agricultural and vegetable
conservation varieties can be registered with reduced uniformity requirements (even with unofficial
tests instead of DUS) and without VCU for agricultural plant species. A historical linkage to their
region of origin is required. Maintenance and marketing is restricted within that region of origin.
Furthermore, the Directives require that in order to benefit from these derogations, it is established
that the varieties are threatened by genetic erosion. The Directives also set quantitative restrictions
on the seed quantities that can be marketed annually for each conservation variety. In addition to
the vegetable conservation varieties, the category of “vegetable varieties with no intrinsic value for
commercial crop production that have been developed under particular conditions”, otherwise
known as ‘amateur’ varieties has been established. These are not subject to geographic or
quantitative restrictions, but their seeds have to be marketed in small packages (i.e. addressed to
amateur gardeners).
At the end of 2021, there were 396 conservation varieties of agricultural plant species and 177 of
vegetable species registered in the common catalogues (representing around 1% of the total number
of varieties)
242
, i.e. the impact of these derogations has been minimal. Many landraces are
cultivated in very small areas and even the derogations regime is considered too burdensome for
these. The little volume of business that can be obtained from the seed commercialisation of
conservation varieties (due to the quantitative and geographic restrictions) are evoked as one of the
reasons for the low number of such varieties being registered in the Common Catalogues
243
.
Finally, the derogations for conservation varieties are not catering for new approaches such as
participatory plant breeding methodologies that aim to develop new locally adapted varieties.
3.
P
RINCIPLES OF THE
FRM
LEGISLATION
The principles of the FRM legislation are quite different from those of the PRM legislation. The
FRM system relies on approved trees called ‘basic material’. These trees have been selected for
superior characteristics (e.g. morphological features, wood quality, health, and resistance) and from
which seeds and other reproductive material will be harvested, certified, and marketed in lots
(Figure 7). FRM is an important driver of the forest-based industries (timber, pulp, furniture,…).
241
242
Commission Directive 2010/60/EU.
Data retrieved from the Common Catalogues.
243
Spataro G. and Negri V. (2013)
129
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1
Figure 7. Pillars of the FRM certification scheme
During certification the identity, quality and health of FRM is checked
Stricter requirements for approval of basic material result in higher FRM quality and
higher market value of FRM
For lower quality FRM, basic material will be checked for basic characteristics (e.g. straightness of
the trunk and symmetry of the side branches). In the case of source-identified material the EU
legislation requires that the basic material is a seed source or stand of trees located within a single
region of provenance
244
. The EU legislation does not describe any criteria to be met by that seed
source and stand
245
. The selection criteria are left at the discretion of the MS. For higher quality
FRM, parent trees will be selected for outstanding characteristics and crossing schemes designed.
NCAs approve basic material through an official inspection following which basic material is
registered in the national catalogue of the MS concerned and subsequently in the EU Common
Catalogue. Upon harvesting seeds and other FRM from basic material NCAs issue a Master
certificate
246
. FRM has to meet the relevant requirements (age, development, health and resistance
of trees in stands to adverse climatic conditions) before the operator can issue a supplier’s
document or supplier’s label.
The registration of basic material, the Master certificate and the supplier’s document/label are
prerequisites for the marketing of FRM throughout the EU (Figure 7). Seeds of agricultural crops
are produced, certified, and harvested in cycles of one year, while in the case of FRM it may take
50-100 years before seeds and forest plants can be harvested from basic material
247
. Global
warming has a negative and increasing impact on Europe's forests by shifting biogeographical
regions northwards and uphill. FRM that used to be optimal for a given region may no longer be fit
244
The provenance is the place in which trees are growing. It is also called the geographic source. For a tree species, the
region of provenance is an area or group of areas subject to sufficiently uniform ecological conditions in which stands
or seed sources showing similar phenotypic or genetic characters are found.
245
Annex II to Council Directive 1999/105/EC. OJ L 11, 15.1.2000, p. 17.
246
The Master certificate provides details about the harvested FRM such as: botanical name, type of FRM (seed unit,
planting stock,…), FRM category (source-identified, selected, qualified or tested material), origin of basic material etc.
247
In the Northern part of Finland and Sweden (e.g. Lapland), the main tree species (e.g. Norway spruce and Scotch
pine) only flower once in a decade.
130
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for that region because of the changing climatic conditions. This makes FRM diversity even more
essential.
The current FRM legislation does not require MS to undertake provenance trials. In such trials,
material of different provenances is planted in a single place or at different locations spanning a
range of environmental conditions. These trials serve to reveal genetic variation among
provenances, as well as differences in the ability of the trees from different provenances to react to
fluctuating environmental conditions. Provenance trials rely on the observation of the phenotypic
characteristics of the trees. Combining molecular markers with provenance trials provides
information on the geographical scale of local adaptation. This information is crucial for selecting
and using FRM in different sites and habitats. The outcome of such provenance trials would
provide information about the area in which FRM is adapted and this would in turn allow FRM
users to take informed decisions on where to best plant FRM. The existing derogatory regime for
the
conservation of forest genetic resources
248
has not been applied by any MS. This is because
the requirements for basic material intended for the purpose of conserving forest genetic resources
are totally different from those of basic material for commercial FRM production. For conservation
small quantities that do not meet the requirements of basic material for commercial use are
needed
249
. Actions to conserve forest genetic resources are taken at national or regional levels, with
the result that knowledge about the conservation and sustainable use of forest genetic resources is
scattered across the EU.
4.
I
NTERACTION WITH OTHER
EU
POLICIES AND INSTRUMENTS
The revision of the PRM and FRM legislation will ensure coherence with the EGD, its
implementing strategies, Common Agricultural Policy and the European Digital Strategy as
described in Figure 8.
248
249
Article 2(4) to Directive 1999/105/EC.
For conservation purposes the entire collection of trees should be kept while only trees with superior characteristics
will be selected in the case of basic material for commercial purposes. It would be necessary to lay down requirements
that are specific for basic material intended for the purpose of conserving forest genetic resources. Examples of material
not meeting the requirements of the FRM rules are vegetative material of poplars for conservation or restoration
activities, seed orchards for conservation purposes and FRM conserved in
in situ
and
ex situ
genebanks.
131
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Figure 8. Interaction with other EU policies and instruments
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5.
I
NTERACTION BETWEEN
FSFS, PRM/FRM
AND
NGT
S
Figure 9 represents the interaction between the overarching legal framework of the FSFS initiative
and the sectoral initiatives on PRM/FRM and NGTs.
Figure 9. Interaction PRM/FRM initiative with NGT and FSFS initiatives
6.
I
NTERPLAY
PROVISIONS
BETWEEN
PRM/FRM
AND
NGT
INITIATIVES AS REGARDS SUSTAINABILITY
The scope of the NGT initiative covers all plant species, while the PRM/FRM initiative covers only
the economically most important species for European agriculture, horticulture and forestry.
Under all options of the PRM/FRM initiative the assessment of sustainability characteristics will be
extended to all crop groups/FRM categories beyond agricultural crops on a voluntary (option 1) or
mandatory basis (options 2 and 3). Both the current VCU for agricultural crops and vine and the
envisaged extended sustainability assessment under the PRM initiative examine in field trials the
overall performance of new varieties
of the regulated species compared to varieties in the
national catalogues in relation to a number of characteristics that would go beyond one or more
introduced traits. The same principle of an overall assessment of basic material in relation to a
number of defined sustainability characteristics holds true for FRM. The PRM/FRM systems will
not provide for the possibility to reject a variety or basic material based on a single trait as inferior
characteristics may be discarded if the variety/basic material as a whole offers clear improvements
in comparison with existing varieties/basic material.
The NGT initiative will regulate the deliberate release including placing on the market of plants
produced using targeted mutagenesis and cisgenesis. NGT plants of the species subject to the
PRM/FRM initiative will need to follow the regulatory procedures of the NGT initiative for their
release and will also be subject to the variety performance assessment of the PRM/FRM. These two
procedures will remain distinct and will apply consecutively, in the same way as today GMOs are
authorised under the GMO legislation prior to the variety assessment (where applicable) under
PRM/PRM.
The NGT initiative is considering options that include certain sustainability-related provisions as
well as options that do not. Should the preferred option include sustainability considerations, the
133
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coherence between the approaches to sustainability will need to be ensured on the basis of the
following considerations:
The NGT initiative considers plants from the perspective of the genetic modification
introduced. In that regard, any sustainability-related provisions (if introduced) would focus
only on the potential of an individual trait introduced to contribute to sustainability (as
opposed to the overall performance in the PRM/FRM systems).
The sustainability considerations relating to an individual trait in the NGT initiative (if any)
would not replace the conduct of or prejudge the outcome of the overall assessment of
performance in the PRM/FRM systems.
Should regulatory consequences in the context of the specific procedure to deliberately
release / place NGTs on the market be introduced in the NGT initiative for specific traits as
regards their potential contribution to sustainability, the relevant traits would need to be
coherent with the list of VCU/sustainability characteristics.
I
NTERPLAY BETWEEN
PRM/FRM
LEGISLATION AND
PHL
7.
Union regulated non-quarantine pests (RNQPs) are currently regulated both under the PHL and
under the marketing Directives as part of the certification requirements. In certain cases, the RNQP
provisions overlap (Table 30). Furthermore, amendments to the PHL and the marketing Directives
are not simultaneous, because changes to the PHL are directly applicable while changes to the
marketing Directives need to be transposed into national legislation.
Regulation of RNQPs under PHL
Implementing Regulation (EU) 2019/2072 sets out specific measures for QPs and RNQPs. Article 5
and Annex IV of that Implementing Regulation establish the list of plants and the respective
thresholds of RNQPs, for internal movement and import while Article 6 and Annex V establish the
measures to be taken in the fields and on the lots of the plants, for internal movement and imports
in order to comply with those thresholds. With the exception of the measures against RNQPs of
fruit plants and vine, the RNQP measures are laid down in Annex V to Implementing Regulation
(EU) 2019/2072. RNQPs for FRM are exclusively regulated under Implementing Regulation (EU)
2019/2072 and thus not under Council Directive 1999/105.
Regulation of RNQPs under marketing Directives
RNQPs are regulated under several PRM acts (Table 30). Currently there are no RNQPs for beet
seed (Directive 2002/54).
In 2020, the provisions of the PRM/FRM legislation were aligned with the requirements of the PHL
including the requirements of Annex V to Implementing Regulation (EU) 2019/2072 through the
following clause: the material “shall
also comply with the requirements concerning Union QPs,
protected zone QPs and RNQPs provided for in implementing acts adopted pursuant to Regulation
(EU) 2016/2031 as well as the measures adopted pursuant to Article 30(1) of that Regulation”.
This means that compliance with RNQP rules, as well as rules on QPs, is a requirement for the
issuance of an official label (under the PRM legislation) or a supplier’s label/document (under the
FRM legislation) following the certification process (official or under official supervision), as
applicable per marketing category of PRM (i.e. pre-basic, basic or certified) or FRM (source-
identified, selected, qualified or tested). Compliance with RNQP and QP rules is also a requirement
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for the issuance of a supplier’s label following a verification process for standard/Conformitas
Agraria Communitatis
(CAC) material). However, the measures on RNQPs for fruit plants and vine
are only included in the respective acts (Commission Implementing Directive 2014/98 and Annexes
to Council Directive 68/193) and not in Annex V to Implementing Regulation (EU) 2019/2072.
Type of PRM/FRM
PHL: relevant reference under
Implementing Regulation
2019/2072)
Part A of Annex IV
Part A of Annex V
PRM/FRM: relevant reference in
PRM/FRM marketing Directive
Council Directive 66/401:
Article 2(3) A and B
Point 5 of Annex I and point 3 of
Annex II: duplication of Part A of
Annex IV (see column 2)
Cereal seed
Part B of Annex IV
Part B of Annex V
Council Directive 66/402:
Article 2(3) A and B
Point 5 of Annex I and point 3 of
Annex II: duplication of Part B of
Annex IV (see column 2)
Vine
Part C of Annex IV
Council Directive 68/193:
Annex I: duplication of Part C of
Annex IV (see column 2)
RNQP measures set out exclusively
under PRM and not in Annex V to
Implementing Regulation 2019/2072
Ornamental plants
Part D of Annex IV
Part C of Annex V
FRM
Part E of Annex IV
Part D of Annex V
Commission Directive 93/49:
Annex: duplication of Part D of
Annex IV (see column 2)
Council Directive 1999/105:
No listing of RNQPs and thus no
duplication of Part E of Annex IV
(see column 2)
Council Directive 2002/54:
Currently no RNQPs
Vegetable seed
Part F of Annex IV
Part E of Annex V
Seed potatoes
Part G of Annex IV
Part F of Annex V
Council Directive 2002/55:
Annex II: duplication of Part F of
Annex IV (see column 2)
Council Directive 2002/56:
Article 3 (only official certification)
Annexes I and II: duplication of Part
G of Annex IV (see column 2)
Seed of oil and fibre plants
Part H of Annex IV
Part G of Annex V
Council Directive 2002/57:
Article 2(3) A and B
Annex II: duplication of Part H of
Annex IV (see column 2)
Fodder plant seed
Beet seed
Currently no RNQPs
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Vegetable propagating material
Part I of Annex IV
Part H of Annex V
Commission Directive 93/61:
Annex: duplication of Part I of Annex
IV (see column 2)
Commission Implementing
Directive 2014/98:
Annexes I, II and III: duplication of
Part J of Annex IV (see column 2)
RNQP measures set out exclusively
under PRM and not in Annex V to
Implementing Regulation 2019/2072
Fruit plants
Part J of Annex IV
Seed of
Solanum tuberosum
L.
Part K of Annex IV
Part I of Annex V
Not regulated
under Directive
2002/56 on seed potatoes
Plant species
not regulated
under the
marketing Directives
Plant species
not regulated
under
Council Directive 2008/90 on fruit
plants
Plants for planting of
Humulus
lupulus
L. other than seeds
Fruit propagating material and fruit
plants intended for fruit production of
Actinidia
Lindl. other than seeds
Part L of Annex IV
Part J of Annex V
Part M of Annex IV
Part K of Annex V
Table 30. Overview of RNQPs per type of PRM and FRM and their regulation in the PHL and marketing Directives.
Annex IV to Implementing Regulation (EU) 2019/2072 lists the RNQPs and specific plants for planting with marketing
categories and thresholds. Annex V to Implementing Regulation (EU) 2019/2072 lists the measures to prevent the
presence of RNQPs on specific plants for planting
Currently, RNQPs are regulated both under the PHL and under the marketing Directives. Under the
PHL, plant passports are issued if it is confirmed that the plants are free from QPs and also comply
with the RNQP thresholds (Annex IV to Implementing Regulation 2019/2072). Under the
PRM/FRM legislation, official labels (or supplier’s labels) are issued if it is confirmed that the
plants comply with the RNQP thresholds. Compliance with those thresholds is ensured through
measures under the regulated certification system (officially or under official supervision):
inspections in the field/production place/production site and sampling and testing of the lots of the
PRM intended for marketing/internal movement. These measures are laid down in Annex V to
Implementing Regulation 2019/2072. However, the rules on the certification system as such are
missing (notification of fields to NCAs, data provision and authorisation process to carry out
certification under official supervision). In the case of fruit plants these measures are described in
Commission Implementing Directive 2014/98 and in the case of vine in Council Directive 68/193.
The PHL falls under the scope of the OCR while the marketing Directives do not. Where risk
management measures against RNQPs are regulated under the marketing Directives (fruit plants
and vines) while the RNQPs are listed in the PHL, there is uncertainty as to whether RNQPs fall
under the scope of the OCR.
The regulation of RNQPs under the PRM/FRM and PHL frameworks, the overlaps between those
frameworks and the different scope of OCs (inside/outside the OCR) leads to uncertainty for MS
and operators about which legislation to adhere to. Consequently, this also results in differences in
implementation and conditions for the operators that could eventually undermine the enforcement
and the quality of controls.
Currently, in 12 out of 27 MS the inspections for RNQPs have been delegated to the NCA
responsible for PRM certification.
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8.
I
NNOVATION AND DIGITALISATION
The application of BMTs in variety registration and PRM/FRM certification
BMTs is a group of molecular biological techniques comprising amongst others DNA sequencing,
molecular markers, genotyping and polymerase chain reaction. BMTs are a promising tool for plant
breeding and PRM certification because they can speed up the identification of plant varieties with
interesting traits. In FRM certification, BMTs can help to certify the origin of FRM, i.e. to confirm
that FRM has been harvested from a particular seed source.
Several EU Horizon 2020 research projects explore the potential of BMTs in variety testing. The
CPVO has created an
ad hoc
working group on the ‘Integration of molecular data into DUS testing’
(IMMODUS) and published the CPVO IMMODUS strategy paper in 2017
250
. The ‘Innovation in
variety testing’ (INVITE) project seeks to develop new phenotyping and genotyping tools to
measure bioindicators associated with plant resource use efficiency, sustainability and resilience. It
aims to improve both the efficiency of variety testing and the information available to stakeholders
on variety performance under a range of production conditions and biotic and abiotic stresses
251
.
The ‘Innovations in plant variety testing’ (Innovar) project aims to augment and improve the
efficacy and accuracy of European crop variety testing and decision-making using an integrated
approach incorporating genomics, phenomics and machine learning
252
.
In PRM, BMTs can be used to speed up DUS testing during the variety registration process or to
allow the rapid and precise confirmation of the identity of the variety during the PRM certification
process and the marketing controls. The DUS test serves to compare the candidate variety with a
number of existing plant varieties (‘reference varieties’). BMTs can help identify which plant
varieties show the highest level of similarity with the candidate variety thus accelerating the
selection of reference varieties for variety examination. During marketing controls, samples of the
marketed PRM are taken and grown in the field whereby the variety to be checked is compared to
the sample of the variety that was retained at the time of variety registration (‘control plot testing’).
Sometimes the observation of the phenotypic characteristics of the variety during the DUS test can
be difficult because the morphological characteristics are not well-expressed. Likewise, the control
plot tests, carried out in the frame of marketing controls, can be inconclusive. Moreover, the large
number of existing varieties, together with the great dynamism of the market as regards new
varieties in many species, make it impossible for inspectors to have technical knowledge of all
existing varieties, as it is impossible to be trained to know hundreds of varieties. This is aggravated
by staff turnover, which makes it in some cases difficult to acquire knowledge through experience.
The OECD Seed Schemes have developed a general rule for the situation when field inspection and
control plot testing are inconclusive. In that case, they allow the use of any other test to obtain
supplementary information in support of the certification decision for the seed lot concerned
including internationally recognised biochemical and molecular techniques performed by an official
250
251
https://cpvo.europa.eu/sites/default/files/documents/cpvo_imoddus_strategy_paper-endorsed_ac_march2017.pdf
https://www.h2020-invite.eu/
252
https://www.h2020innovar.eu/variety-testing-community/
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laboratory
253
. Moreover, the OECD maintains a list of internationally recognised methods that are
currently used by the National Designated Authorities.
UPOV has so far developed two models for the use of BMTs in variety testing. The first concerns
the use of BMTs for identifying in the variety reference collection (i.e. varieties of common
knowledge in the EU) the varieties with the highest level of similarity to the candidate variety for
the purpose of the DUS test. The second concerns the use of trait-specific molecular markers
whereby the reliability of the link between the marker and the trait is verified
254
. UPOV, OECD and
the International seed testing association have joint initiatives in relation to BMTs. In spite of the
fact that BMTs offer the means to increase the efficiency of PRM/FRM certification and render the
PRM/FRM sector more competitive, the PRM/FRM legal framework currently does not contain
any common rules on BMTs that explicitly allow the use of BMTs, with the exception of the
verification of varietal identity in the certification of agricultural plant species
255
. This creates legal
uncertainty around the use of BMTs. For example, during marketing controls the verification of the
identity of the variety by means of BMTs could be contested in the case of fraud due to the absence
of a legal framework. As described above, the OECD and UPOV allow the use of BMTs under
certain conditions. This has led certain MS to adopt national approaches on BMTs while others
have not
256
. Additionally, the PRM/FRM legal framework is increasingly diverging from the
ongoing developments at international level.
Digitalisation
The EU digital strategy aims to make the transformation to digital technologies work for people and
businesses, while helping to achieve its target of a climate-neutral Europe by 2050. The PRM/FRM
legal framework does not contain any common rules on the use of digital technologies. COVID-19
has demonstrated that digital technologies can help improve the resilience of agricultural supply
chains during emergency situations by issuing digital certificates. Moreover, the use of digital
certificates and documents reduces the risk of fraud. Therefore, the use of digital labels and
certificates should also be introduced in the PRM/FRM legislation. The OECD Seed Schemes and
the OECD Forest Scheme already use digital labels. Those labels can be downloaded from a secure
website. If the National Designated Authority of an OECD member country wants to use digital
labels for the marketing of PRM/FRM, they need to complete the digital label and ask the OECD
Secretariat to authorise the use of those digital labels.
The use of digital technologies can be taken a step further by digitalising the entire seed
certification system. The OECD Secretariat has conducted a feasibility study on this topic that was
finalised in 2021. In 2023, the OECD Secretariat will launch a project on digitalisation of the
OECD Seed Schemes applied to the seed certification system for seed moving in international
trade, with the intention to develop a seed certification hub where all certification information will
be stored. In the future this can be augmented by the use of blockchain technology. A blockchain
keeps records shared between parties in a network and stores information about all transactions
253
254
OECD Seed Schemes Rule and Regulations 2022, common rules 7.4.5.1.
UPOV TGP15: Guidance on the Use of Biochemical and Molecular Markers in the Examination of Distinctness,
Uniformity and Stability (DUS).
255
Commission Implementing Directive (EU) 2021/971.
256
For example, in Spain BMTs are used in plant breeding, to select reference varieties for the DUS test and to carry
out marketing controls. In Germany, BMTs are used to certify the origin of FRM.
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between those parties in a chronological order. The advantage is that there is no central record-
keeping authority. The advantages that have been identified in OECD’s feasibility study would also
apply to PRM/FRM certification. Digitalisation represents a significant opportunity to future-proof
the existing certification system and modernise the PRM and FRM sector.
The following benefits are expected from digitalisation of PRM/FRM certification:
Efficiency gains and cost reduction: reduced administrative burden, simplified reporting
requirements, reduced transition costs, and identification of new opportunities.
Risk reduction: increased trust in the EU certification framework by reducing the risk of
fraudulent products and increasing transparency and traceability.
Business continuity: build a more resilient PRM/FRM sector, help protect supply chains
against future disruptions and help identify and manage risks more quickly.
Spark innovation: create a sustainable future for the PRM/FRM sector and the value chain
that utilises certified PRM/FRM.
There are also some disadvantages of digital transformation of the agri-food sector. It involves
significant transaction and infrastructure costs
257
. For the transformation to be successful all parties
involved should be able to benefit from it
258
. There are concerns that not all stakeholders or MS
will. It may be economically challenging for SMEs to adapt to new technologies bringing them in a
disadvantageous position in comparison to larger enterprises. Most NCAs agreed that the cost of
the technology should decrease for the benefits of its implementation to outweigh the risks as
regards the security of new technology and costs. They recognised that there are already systems in
place that could be extended and applied in the PRM sector with one NCA stating that in most MS
data is already digitalised
259
.
Goedde, Lutz, Joshua Katz, Alexandre Menard and Julien Revellat (2020) Agriculture’s connected future: How
technology can yield new growth. McKinsey. Available at:
https://www.mckinsey.com/industries/agriculture/our-
insights/agricultures-connected-future-how-technology-can-yield-new-growth#
258
Wang, Y., Han, J. H., and Beynon-Davies, P. (2019). Understanding blockchain technology for future supply chains:
a systematic literature review and research agenda. Supply Chain Management: An International Journal.
259
Reponses to interviews Section 4.2.2.4 to ICF(2021) Data gathering study.
257
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9.
O
FFICIAL CONTROLS
9.1.
Legal analysis
Table 19 compares the requirements on OCs in the PRM and FRM Directives with those in the OCR. To allow this comparison the provisions in several
PRM Directives on official certification and the issuance of an official label were interpreted as provisions on ‘official attestations’ within the meaning of
the OCR. The OCR makes provisions on official attestations issued by operators under the official supervision of the NCAs, or by the NCAs themselves.
However, in the PRM/FRM legislation official certification is a product authorisation process. In the case of the PRM and FRM legislation this means
that official certification and the issuance of an official label can only be decided by the NCAs themselves (Annex 5, Section 2.2.1.).
Table 19. Requirements on official controls in the PRM and FRM marketing Directives against OCR requirements
OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
140
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Y
Definition of
‘official
measures’
262
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
N
Only a
definition of
‘official
measures’
264
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
N
Only a
definition of
‘official
measures’
266
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
N
Only a definition
of official
measures
267
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Y
Definition of
‘supplier’,
‘responsible official
body’
268
.
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Y
Definition of
‘supplier’,
‘responsible
official body’
269
;
‘official
measures’
270
;
‘official
inspection’
271
;
‘official
statement’
272
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Y
Definition of
‘supplier’,
‘responsible official
body’
273
, “official
inspection’
274
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Y
Only a definition
of ‘supplier’,
‘official body’
275
Definitions
(Art. 2 and 3)
N
Only a
definition of
‘official
measures’
260
N
Only a
definition of
‘official
measures’
261
N
Only a definition
of ‘official
measures’
263
N
Only a definition
of ‘official
measure
265
Art. 1.E: “Official measures: measures taken (a) by State authorities, or (b) by any legal person whether governed by public or by private law, acting under the responsibility of the State, or (c) in the case of ancillary activities
which are also subject to State control, by any natural person duly sworn for that purpose, provided that the persons mentioned under (b) and (c) derive no private gain from such measures.” Key concepts not defined such as:
‘official inspections’; ‘official inspectors’; ‘official examination’; ‘seed certification authority’; ‘official seed samplers’; ‘official label’; ‘official seal’.
261
Art. 2(1)(H),
Ibidem.
Key concepts not defined such as: ‘official inspections’; ‘official inspectors’; ‘official examination’; ‘seed certification authority’; ‘official seed samplers’; ‘official label’; ‘official seal’.
262
Article 2.
263
Article 1(g). Ibidem.
264
Article 2(1)(f),
Ibidem.
Key concepts not defined such as: ‘official inspections’; ‘official inspectors’; ‘official examination’; ‘seed certification authority’; ‘official seed samplers’.; ‘official label’ ; ‘official seal’.
265
Article 2(d),
Ibidem.
Key concepts not defined such as: such as: ‘official inspections’; ‘official examination’; ‘certification authority’; ‘official label’; ‘official seal’.
266
Article 2(1)(k),
Ibidem.
Key concepts not defined such as: ‘official inspections’; ‘official inspectors’; ‘official examination’; ‘seed certification authority’; ‘official seed samplers’; ‘official label’; ‘official seal.
267
Article 2(1)(H), Ibidem. Key concepts not defined, such as ‘official control authority’; ‘official inspection’; ‘official examination’;’officially certified’; ‘‘officially checked’ ; ‘official label’; ‘official controls’.
268
Article 2(4) : « ‘Responsible official body’: (a) an authority, established or designated by the Member State under the supervision of the national government and responsible for questions concerning quality; (b) any State
authority established: — either at national level, or — at regional level, under the supervision of national authorities, within the limits set by the constitution of the Member State concerned”.
269
Article 3(e): « ‘responsible official body’ means: (i) the sole and central authority, established or designated by the Member State under the supervision of the national government and responsible for questions concerning
quality; (ii) any State authority established: — either at national level, — or at regional level, under the supervision of the national authorities within the limits set by the national legislation of the Member State concerned.”.
270
Article 3(f): “‘official measures’ means measures taken by the responsible official body;”.
271
Article 3(g): « ‘official inspection’ means an inspection carried out by the responsible official body;”.
272
Article 3(h) : « ‘official statement’ means a statement issued by, or under the responsibility of, the responsible official body;”.
273
Article 2(11): “ ‘responsible official body’ means: (a) an authority, established or designated by the Member State under the supervision of the national government and responsible for questions concerning the quality of
propagating material and fruit plants; (b) any State authority established: — either at national level, or — at regional level, under the supervision of the national authorities, within the limits set by the national legislation of the
Member State concerned;”.
260
141
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Y
Confidentiality
obligations
279
,
other
obligations of
competent
authorities
280
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Y
Provisions on
confidentiality
obligations
282
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Y
Limited
provisions on
confidentiality
obligations
283
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
N
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Y
Limited in the form
of: designation of a
responsible official
body
284
and
notification thereof
to the Commission
285
; official
registration of
suppliers
286
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Y
Limited in the
form of
designation of a
responsible
official body and
notification
thereof to the
Commission
287
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Y
Limited in the form
of designation of a
responsible official
body; official
registration of
suppliers
288
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Y
Limited in the
form of
designation of an
official body and
notification
thereof to the
Commission
289
;
official
registration of
Rules on
competent
authorities
276
(Art. 4 to 8)
N
277
.
N
278
N
281
N
Article 2(12): “‘official inspection’ means inspection carried out by the responsible official body or under the responsibility of the responsible official body;”
Article 2(k): ‘Official body: (i) an authority, established or designated by the Member State under the supervision of the national government and responsible for questions concerning the control of marketing and/or the quality
of FRM; (ii) any State authority established:
- either at national level, or- at regional level, under the supervision of national authorities, within the limits set by the constitution of the Member State concerned.”.
276
i.e. designation, general obligations, audits, right of appeal, confidentiality obligations.”.
277
There are rules on the responsibilities of the seed certification authority prior to certification, in particular in the context of official examination under supervision, with no further specifications.
278
There are rules on the responsibilities of the seed certification authority prior to certification, in particular in the context of official examination under supervision) with no further specifications.
279
Art. 7(3).
280
Where acceptance of a variety is refused or revoked, the results of the examinations shall be made available to persons affected by such decision (Art. 10(5)).
281
There are rules on the responsibilities of the seed certification authority prior to certification, in particular in the context of official examination under supervision) with no further specifications.
282
Article 7(3) (in the framework of examination of the genealogical components, obligation to treat as confidential the results of the examination and the description of the genealogical components, if the breeder so requests);
Article 10(3) (information exchanged by MS and the Commission in relation to the files compiled by MS on each variety accepted must be treated as confidential); Article 10(5) - in case the acceptance of a variety is refused or
revoked, the results of the examinations shall be made available to persons affected by such decision.
283
Article 8: « Member States shall provide that the description of genealogical components which may be required is, if the breeder so requests, treated as confidential.”.
284
Article 2(4)(a) and (b).
285
Article 2(4), last subparagraph.
286
Article 6.
287
Article 3(e).
288
Article 5(1).
289
Article 2(k) last subparagraph.
274
275
142
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
suppliers
290
Risk based
controls
291
(Art.
9(1) and (2))
N
- random
checks on
marketing
292
;
fixed
percentage of
checks for
official
supervision
(5%)
N
- random
checks on
marketing
293
;
fixed
percentage of
checks for
official
supervision
(5%)
N
N
- random checks
onmarketing
294
;fix
ed percentage of
checks for official
supervision (5%)
N
-random
checks on
marketing
295
;
fixed
percentage of
checks for
official
supervision
(5%)
N
- random checks
on marketing
296
N
-random
checks
297
;
fixed
percentage of
checks for
official
supervision
(5%)
N
N
N
Y
In the form of
sampling and testing
requirements on the
basis of an
assessment of the
risk of infection of
plants
298
N
290
291
Article 6(4).
with appropriate frequency, including criteria for risk-based controls and including to identify fraudulent activities.
292
Article 19(1): “Member States shall ensure that official inspections are carried out in relation to the marketing of fodder plant seed, at least by random checks, to verify compliance with the requirements and conditions of this
Directive.”
293
Article 19(1): “ Member States shall ensure that official inspections are carried out in relation to the marketing, at least by random checks, to verify compliance with the requirements of this Directive.”
294
Article 25(1): “Member States shall ensure that official inspections are carried out in relation to the marketing of beet seed, at least by random checks, to verify compliance with the requirements and conditions of this Directive.
295
Article 39(1): “Member States shall ensure that official inspections are carried out in relation to the marketing of vegetable seed, at least by random checks, to verify compliance with the requirements and conditions of this
Directive.”
296
Article 23(1) : «Member States shall ensure that official inspections are carried out in relation to the marketing of seed potatoes, at least by random checks, to verify compliance with the requirements and conditions of this
Directive.”
297
Article 22(1) : «Member States shall ensure that official inspections are carried out in relation to the marketing of seed of oil and fibre plants, at least by random checks, to verify compliance with the requirements of this
Directive.”.
298
Annex IV to Implementing Directive 2014/98/EU.
143
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Y
MS to provide
that the
acceptance of
varieties be
based on the
results of
official
examinations,
particularly
growing trials,
covering a
sufficient
number of
characteristics
for the variety
to be
described
304
+
minimum
requirements
for official
examinations
305
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Y
detailed rules
on
examination
under official
supervision+
minimum
number of field
inspections
(official or
under official
supervision)+
rules on official
examinations
for the
acceptance of
varieties
309
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Y
Detailed rules
on
examination
under official
supervision
312
+ rules on
official
examination
prior to
certification
313
+ minimum
conditions and
minimum
number of field
inspections
(official or
under official
supervision)
314
+ examinations
to be carried
out in
accordance
with current
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Y
Official
examination
required prior to
certification
316
+
detailed rules on
official
inspections of
growing crops
317
+ rules on official
examinations for
the acceptance of
varieties
318
.
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Y
Random checks +
implementing
powers
319
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Y
Accreditation of
suppliers
320
+
rules on regular
supervision and
monitoring of
suppliers,
establishments
and
laboratories
321
+
implementing
powers +
MS to ensure
official inspection
by sampling
checks on
material during
production
322
+implementing
powers for
detailed
procedures for
such controls
323
see also Article
Regular
controls (prior
to placing on
the market)(Art.
9(1))
Y
detailed rules
on
examination
under official
supervision
299
+ rules on
official
examination
prior to
certification
300
Y
detailed rules
on
examination
under official
supervision
301
+
rules on official
examination
prior to
certification
302
+
minimum
number of field
inspections
(official or
under official
supervision
303
Y
detailed rules on
examination
under official
supervision
306
+
rules on official
examination prior
to certification
307
+
minimum number
of field
inspections
(official or carried
out under official
supervision)
308
Y
Limited rules on
examination
under official
supervision
310
.
Official
examination
required prior to
placing on the
market
311
.
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Y
Official inspection
required to
determine if material
meets conditions
325
+ MS
to ensure that
material/ fruit plants
are officially
inspected during
production
326
+
detailed rules on
official
inspections
327
+
rules on
examination of
varieties prior to
registration
328
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Y
Approval of ‘basic
material’, re-
inspection at
regular
intervals
329
and
national
registry
330
299
300
Article 2(3).
only seed found to satisfy applicable conditions by means of official examination or examination under official supervision can be certified.
301
Article 2(3).
302
only seed found to satisfy applicable conditions by means of official examination or examination under official supervision can be certified.
303
Annex I, point 7.
304
Article 7(1).
305
Article 7(2) and Commission Directive
2003/90/EC
of 6 October 2003 setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC as regards the characteristics to be covered as a minimum
by the examination and the minimum conditions for examining certain varieties of agricultural plant species (Text with EEA relevance).
306
Article 2(3).
144
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307
308
Only seed found to satisfy applicable conditions by means of official examination or examination under official supervision can be certified.
Annex I (2): “In the case of basic seed, at least one official field inspection shall be carried out. In the case of certified seed, at least one field inspection shall be carried out, officially controlled by means of check inspection of at
least 20 % of the crop of each species”.
309
MS to provide that acceptance of varieties be based on the results of official examinations, particularly growing trials (Article 7(1)); possibility to provide in EU implementing acts that acceptance is subject to official tests (Art.
7(1), last subparagraph); the characteristics to be covered as a minimum by the examinations of the various species and the minimum requirements for carrying out the examinations are established in implementing acts (See
Commission Directive
2003/91/EC
of 6 October 2003 setting out implementing measures for the purposes of Article 7 of Council Directive 2002/55/EC as regards the characteristics to be covered as a minimum by the examination
and the minimum conditions for examining certain varieties of vegetable species (OJ L 254, 8.10.2003, p. 11).
309
Article 12(1) and 13 (1)(a).
310
Article 12(1) and 13 (1)(a):possibility of package sealing and of indelible printing of the prescribed particulars on the package under official supervision.
311
Article 2 (seed must be found by official examination to satisfy the conditions laid down in the Directives).
312
Article 2(5).
313
Article 2 (only seed found to satisfy applicable conditions by means of official examination or examination under official supervision can be certified).
314
Annex I.5.
316
Article 2(1) (D) to (G) (Material must be found by official examination to satisfy the conditions established in the Directive in view of the certification). Similarly, propagating material not intended for use as rootstocks, may
only be placed on the market if it is officially checked standard material (Article 3(1)(a)).
317
Annex I (stock nurseries and cutting nurseries, including in relation to RNQP (visual inspection, sampling and testing)). This includes including annual official crop inspections, by the official control authority, in accordance
with rules established in Section 8 of Annex (Annex I, Section 5).
318
Article 5d(1) (MS to ensure that acceptance of varieties is based on the results of official examinations, particularly growing trials, covering a sufficient number of characters for the variety to be described. The methods used for
determining characters must be exact and reliable).
319
Article 12.
320
Article 6(1) (by the responsible official body after it has verified that their production methods and establishments meet the requirements of the Directive).
321
Article 6(4).The supervision and monitoring of suppliers, establishments and laboratories shall be carried out regularly by or under the responsibility of the responsible official body.
322
Article 17.
323
Article 18.
325
Article 2(5)(d) ; 2(6)(d) ; Article 2(7)(a)(iv) ; Article 2(7)(b)(iv).
326
Article 13(1).
327
Article 30 and Annex IV of Implementing Directive 2014/98/EU (visual inspections, sampling and testing).
328
Article 7(5) and Article 6 of Commission Implementing Directive
2014/97/EU.
329
Article 4 and Annex II (It shall be at the discretion of the Member State in each individual case as to whether a formal inspection is required except that, a formal inspection must be made where the material is destined for a
specific forestry purpose), Annex III, IV and V.
330
Article 10(1).
145
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
international
methods
315
.
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
10(3).
+ rules of
Directive 2002/55
apply for
acceptance and
maintenance of
varieties
324
.
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Regular
controls - on
the marketing
(Art. 9(1))
Y
Minimum
rules- random
checks
331
Y
Minimum rules
– random
checks
332
Y
There are no
specific rules,
there are
solely
provisions on
maintenance
and revocation
of varieties
Y
Minimum rules –
random checks
333
Y
Minimum rules
-random
checks
334
+ rules on
verification of
maintenance
of accepted
varieties
335
.
Y
Minimum rules -
random checks
336
+
further official
examination
required on
tubers which are
not rejected after
Y
Minimum rules
- random
checks
338
Y
Accepted
varieties shall be
officially checked
at regular
intervals
339
+
rules on
verification of
maintenance for
Y
Minimum rules, at
least random checks
and at least in
respect of marketing
to persons
professionally
engaged in
production or
Y
Regular
supervision and
monitoring of
suppliers,
establishments
and laboratories
+ implementing
powers
344
Y
MS to ensure
material/ fruit plants
are officially
inspected during
marketing
348
+
detailed rules on
official inspections in
implementing act
349
Y
Official
inspections of
registered
suppliers to be
carried out
regularly
351
.
MS to make
suitable
315
324
Article 3(4).
Article 9(2) and (3). The provisions laid down in Articles 4 and 5 and Article 9(3) of Directive 2002/55/EC shall apply to the conditions for acceptance. Article 3(2) and (4), Articles 6, 7, 8, 9(1), (2) and (4) and Articles 10 to 15
of that Directive shall apply mutatis mutandis to the procedures and formalities for acceptance and maintenance production. Varieties officially accepted in accordance with paragraph 2 shall be entered in the Common Catalogue of
Varieties of Vegetable Species referred to in Article 17 of Directive 2002/55/EC. Articles 16(2), 17, 18 and 19 of that Directive shall apply mutatis mutandis.
331
Article 19(1): “Member States shall ensure that official inspections are carried out in relation to the marketing of fodder plant seed, at least by random checks, to verify compliance with the requirements and conditions of this
Directive.”
332
Article 19(1): “Member States shall ensure that official inspections are carried out in relation to the marketing, at least by random checks, to verify compliance with the requirements of this Directive.”
333
Article 25(1): “Member States shall ensure that official inspections are carried out in relation to the marketing of beet seed, at least by random checks, to verify compliance with the requirements and conditions of this Directive.”
334
Article 39(1): “Member States shall ensure that official inspections are carried out in relation to the marketing of vegetable seed, at least by random checks, to verify compliance with the requirements and conditions of this
Directive.” Random checks also to verify compliance with the obligations of the persons responsible for affixing the labels for the standard seed intended for marketing (Article 41(1) last subparagraph). In addition, it is required
that MS ensure that seed of the categories ‘certified seed’ and ‘standard seed’ is subject to official post-control in the field by inspection to compare their varietal identity and varietal purity against standard controls
335
Article 11(1) to (3). It must at all times be possible to check maintenance of accepted varieties from the records kept by the person or persons responsible for the variety. These records shall also cover the production of all
generations prior to basic seed.
146
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
conservation of
accepted
varieties
340
.
+ MS to establish
a system of
official controls of
material during
marketing, at
least by check
sampling
341
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
sale
342
;
implementing
powers for detailed
implementing
procedures for
official inspections
343
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
MS to ensure
official inspection
by sampling
checks on
material during
marketing
345
+implementing
powers for
detailed
procedures for
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
+ trials or tests shall
be carried out in the
MS on samples
350
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
arrangements for
FRM to be
officially
controlled during
production with a
view to marketing
and
marketing
352
.
sorting
337
Samples may be requested from the person responsible for the variety. Such samples may if necessary be taken officially (Article 40).
336
Article 23(1) : « 1. Member States shall ensure that official inspections are carried out in relation to the marketing of seed potatoes, at least by random checks, to verify compliance with the requirements and conditions of this
Directive.”
338
Article 19(1): “1. Member States shall ensure that official inspections are carried out in relation to the marketing of fodder plant seed, at least by random checks, to verify compliance with the requirements and conditions of this
Directive.”
339
Article 5e(1).
344
Article 6(4).
348
Article 13(1).
349
Article 30 and Annex IV of Implementing Directive 2014/98/EU (visual inspections, sampling and testing).
351
Article 16(1). MS to ensure, by an official control system set up or approved by them, that FRM from individual units of approval or lots remains clearly identifiable through the
entire process from collection to
delivery
to the end user
337
Article 3(1).
340
Article 5g(2). Verification of maintenance for conservation of varieties accepted in the catalogue on the basis of records to be kept by those responsible for maintenance; samples may be requested from those responsible for
maintenance of a variety. Where necessary, samples may be taken officially.
341
Article 11(1).
342
Article 12(1): “Member States shall require that suppliers take all necessary measures to guarantee compliance with the requirements of this Directive. To this end Member States shall ensure that propagating material is
officially inspected: — at least by random checks, and
— at least in respect of marketing to persons professionally engaged in production or sale of ornamental plants or propagating material, to verify compliance with the requirements. Member States may also take samples in order to
verify compliance. In carrying out supervision and monitoring, the responsible official bodies shall have free access to all parts of suppliers' establishments at all reasonable times.”
343
Article 12(2).
345
Article 17.
147
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
such controls
346
+trials or tests
shall be carried
out in the MS on
samples
347
Y
In the form of
operators’
obligations
364
+
implementing
powers
365
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Other general
rules on official
controls
353
(Art.
11 to 15)
N
Y
Limited
354
Y
Limited
355
Y
Limited
356
Y
Limited
357
.
N
Y
Limited
358
.
Y
+
implementing
powers
360
+obligations for
certain
operators
361
359
Y
Limited in the form
of obligations of
suppliers
362
; supplier
label
363
.
Y
Limited, in the form
of operators’
obligations
366
.
Y
Limited in the
form of
suppliers’s
obligations
367
350
352
Article 14(1).
Article 16(5).
346
Article 18.
347
Article 20(1).
353
Transparency of official controls; documented control procedures; written records of official controls; methods and techniques of official controls; obligations of operators.
354
In the form official examination of seed to be carried out in accordance with current international methods (Article 3(3)). Also, use of examination techniques in accordance with applicable international standards for the
examination of the varietal identity of the seed.
355
Obligation for operators (record keeping in relation to maintenance of varieties (Art. 11(2)).
356
MS to ensure that official examinations of seed are carried out in accordance with current international methods (Article 3(2)).
357
MS to ensure that official examinations of seeds are carried out in accordance with current international methods (Article 20(4).
358
In the form of official examinations for certification to be carried out in accordance with current international methods (Article 3(4)).
359
In the form of methods used for official examination varieties acceptance (Article 5d(1)). The requirement is that those methods must be exact and reliable.
360
On minimum requirements for examinations, in particular crop inspections Article 5d(2). See Commission Directive
2004/29/EC
of 4 March 2004 on determining the characteristics and minimum conditions for inspecting vine
varieties.
361
Obligation of recipient of the material for the vegetative propagation of the vine to keep the official label for at least one year and to make it available to the official control authority (Article 10(5)). Obligation of those
responsible for maintenance of varieties for conservation to keep records in view of inspection. Keeping of records of varieties maintained for conservation.
362
Suppliers engaged in production of propagating material shall keep information, for examination when requested by the responsible official body (Article 7(1)). Reporting obligations (Article 7(2)). Record keeping (Article 7(3)).
363
Article 8(2) and Commission Directive
1999/66/EC
of 28 June 1999 setting out requirements as to the label or other document made out by the supplier pursuant to Council Directive 98/56/EC (Official Journal L 164 ,
30/06/1999 P. 0076).
148
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Staff training
(Art. 5(4))
N
368
N
369
N
N
370
N
371
N
N
372
N
N
N
N
373
.
N
364
Own checks (Article 5(2): Obligation of suppliers to carry out own checks, or have them carried out by an accredited supplier or by a responsible official body based on principles laid down in the Directive to guarantee
compliance at all stages of production and marketing; identification of critical points; establishment and implementation of methods for monitoring and checking the critical points; taking samples for analysis in a laboratory
accredited by the responsible official body for the purpose of checking compliance with the standards established by the Directive; keeping a written record or a record registered in an indelible fashion of the data referred to in the
first, second and third indents, as well as records on production and marketing of propagating and planting material, to be held at the disposal of the responsible official body. These documents and records shall be kept for a period
of at least one year); reporting obligations and to take corrective actions (Article 5(3)).
365
Article 5(4).
366
Article 30(3) of Implementing Directive 2014/98/EU (to keep records of the results and dates of all field inspections, sampling and testing carried out by them).
367
Ariticle 16(3): “Suppliers shall provide official bodies with records, which shall contain details of all consignments detained and marketed”.
368
Requirements are established only for inspectors and seed samplers working under official supervision.
369
Only requirements for inspectors and seed samplers working under official supervision.
370
Only requirements for inspectors and seed samplers working under official supervision.
371
Only requirements for inspectors and seed samplers working under official supervision.
372
Only requirements for inspectors and seed samplers working under official supervision
373
Competence of suppliers’ staff is to be checked in official inspections (Article 30(2)(b) of Implementing Directive 2014/98/EU).
149
 kom (2023) 0414 - Ingen titel
2733822_0151.png
OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Y
See minimum
requirements
for
examinations
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Y
377
But no
cascade of
applicable
methods s as
in Article 34 of
the OCR.
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Y
379
But no
cascade of
applicable
methods as in
Article 34 of
the OCR.
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Y
380
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
N
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
N
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Y
A cascade of
methods to be used
for sampling
381
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Y
See provisions in
Annexes II to V
Methods of
sampling,
analysis, tests
and diagnoses
(Art. 34)
Y
374
But no
cascade of
applicable
methods as in
Art. 34 of the
OCR
Y
375
But no
cascade of
applicable
methods as in
Article 34 of
the OCR.
Y
376
But no cascade
of applicable
methods as in
Article 34 of the
OCR.
Y
378
But no cascade
of applicable
methods as in
Article 34 of the
OCR.
MS are to require that sampling is performed in accordance with ‘appropriate methods’ (Art. 7); Detailed requirements on ‘sampling under official supervision (Article 7(b); seed samplers must carry out seed sampling in
accordance with current international methods; Detailed technical rules (requirement of sampling from homogenous lots; maximum eight of the lot and minimum weight of the sample (Article 7(2) and Annex III).
375
MS to require that, for the checking of varieties, and for the examination of seed for certification, samples are drawn officially or under official supervision in accordance with appropriate methods (Art. 7(1); seed samplers shall
carry out seed sampling in accordance with current international methods (Art. 7(1a)(b)); detailed provisions on seed sampling (Article 7(2) and Annex III: for the examination of seed for certification, samples shall be drawn from
homogeneous lots; the maximum weight of a lot and the minimum weight of a sample are given in Annex III); authorised seed testing laboratories shall carry out seed testing in accordance with current international methods
(Article 2(3)(b));
376
Article 9(1) : “Member States shall require that, for the checking of varieties, and for the examination of seed for certification, samples are drawn officially or under official supervision in accordance with appropriate methods
(…).”; detailed requirements on ‘sampling under official supervision’; seed samplers must carry out seed sampling in accordance with current international methods (Article 9(1a)(b)); detailed provisions on seed sampling (Annex I,
Section 2, point 4 : “As regards sampling and testing, Member States shall apply protocols of the European and Mediterranean Plant Protection Organisation (EPPO), or other protocols which are internationally recognised. Where
such protocols do not exist, the relevant protocols established at national level shall be applied. In that case, Member States shall, on request, make available those protocols to the other Member States and to the Commission. As
regards sampling and testing of vines in the stock nurseries intended for the production of initial propagating material, Member States shall apply biological indexing on indicator plants to assess the presence of viruses, viroids,
virus-like diseases and phytoplasmas, or other equivalent protocols which are internationally recognised.”); authorised seed testing laboratories shall carry out seed testing in accordance with current international methods (Article
2(3)(B)(b), last subparagraph); Use of examination techniques in accordance with applicable international standards (Annex I, A, 5a); MS shall require that, for the examination of seed for certification, samples are drawn officially
or under official supervision in accordance with appropriate methods (Article 25); See samplers shall carry out seed sampling in accordance with current international methods (Article 25(1a)(b)).
377
Authorised seed testing laboratories shall carry out seed testing in accordance with current international methods (Article 2(4)(B)); the methods used for determining characteristics must be accurate and reliable (Article 7(1)); for
the examination of seed for certification and for post-control tests, samples shall be drawn from homogeneous lots; the maximum weight of a lot and the minimum weight of a sample are given in Annex III (Article 25(2));
examination in accordance with the applicable international standards (Annex I (3a)).
378
MS shall require that, for the examination of seed potato tubers for certification, samples are taken officially in accordance with appropriate methods (Article 7).
379
MS shall require that, for the checking of varieties, the examination of seed for certification and the examination of commercial seed, samples are drawn officially or under official supervision in accordance with appropriate
methods (Article 9(1)); detailed requirements on ‘sampling under official supervision’; seed samplers must carry out seed sampling in accordance with current international methods (Art. 9(1a)(b)); detailed provisions on seed
374
150
 kom (2023) 0414 - Ingen titel
2733822_0152.png
OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
N
382
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
N
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
N
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
N
383
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
N
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
N
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
N
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
N
Second expert
opinion
(Art. 35)
Sampling of
animals and
goods offered
by means of
distance
communication
(Art. 36)
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
sampling (Article 9(2) : « 2. For the examination of seed for certification and the examination of commercial seed, samples shall be drawn from homogeneous lots; the maximum weight of a lot and the minimum weight of a
sample are given in Annex III.”
Annex I. 3a); use of examination techniques in accordance with applicable international standards (Annex I. 3a).
380
In relation to methods of sampling and testing of stock nurseries and cutting nurseries.
381
See recital 14 of Implementing Directive 2014/98/EU: “Where sampling and testing is carried out, it should take place in accordance with the protocols of the European and Mediterranean Plant Protection Organization (EPPO),
or other protocols which are internationally recognised. This is necessary to ensure that the practice of sampling and testing carried out in the Union is up to date with the international scientific and technical developments. Where
such protocols are not available, sampling and testing should take place in accordance with relevant protocols established at national level.”
382
To be noted that MS are to ensure that any doubts which arise after the acceptance of a variety concerning the appraisal of its distinctness or of its name at the time of acceptance are clarified (Art. 13(1)).
383
There is only a reference to the obligation of the official control authority to carry out additional checks on stock nurseries and cutting nurseries in case of cases of disputes on matters which can be decided without prejudice to
the quality of the propagating material (Annex I, Section 5, point 3).
151
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2733822_0153.png
OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
N
386
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
N
388
.
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
N
390
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
N
391
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Y
But in accordance
with national law
392
+
implementing
powers
for the approval of
other legal
persons
393
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Y
But in
accordance with
national law
394
+
implementing
powers
for the approval
of other legal
persons
395
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Y
But in accordance
with national law
396
+
implementing
powers
for the approval of
other legal
persons
397
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Y
But in accordance
with national
law
398
+
implementing
powers
for the approval
of other legal
persons
399
Delegation of
tasks of the
competent
authorities (Art.
28 to 33)
N
384
N
385
N
387
N
389
In the definition of ‘official measures’ reference is made to measures taken by any legal person whether governed by public or by private law, acting under the responsibility of the State; or in the case of ancillary activities which
are also subject to State control, by any natural person duly sworn for that purpose. However, there are no further specifications. Similarly, Union comparative tests and trials may be performed by State authorities, but also by legal
persons acting under the responsibility of the State. However, there are no further provisions concerning these legal persons.
385
Ibidem.
386
In the definition of ‘official measures’ reference is made to measures taken by any legal person whether governed by public or by private law, acting under the responsibility of the State; or in the case of ancillary activities which
are also subject to State control, by any natural person duly sworn for that purpose.
387
Ibidem.
388
Ibidem.
389
Ibidem.
390
Ibidem.
391
Ibidem.
392
Article 2(4), second subparagraph: « The bodies referred to above may, in accordance with their national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to
any legal person, whether governed by public or by private law, which, under its officially approved constitution, is charged exclusively with specific public functions, provided that such person, and its members, has no personal
interest in the outcome of the measures it takes.” In addition, Community comparative tests and trials may be performed by State authorities and also by legal persons acting under the responsibility of the State (Article 14(7)).
393
Article 2(4), third subparagraph.
394
Article 3(e), second and third subparagraph. See also Article 20(7) in relation to comparative tests and trials.
395
Article 3(e), fourth subparagraph (established on behalf of the responsible official bodies and acting under the authority and supervision of such body).
396
Article 13(2), first subparagraph: ‘The responsible official bodies may, in accordance with their national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to
any legal person, whether governed by public or private law, which, under its officially approved statute, is charged exclusively with specific public functions, provided that such person, and its members, has no personal interest in
the outcome of the measures it takes.”. See also definition of ‘official inspections’. See also provisions on tests and trials only by State authorities or legal persons acting under the responsibility of the State Tests and trials only by
State authorities or legal persons acting under the responsibility of the State (Article 14(7)).
397
Article 13(2), second subparagraph.
384
152
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Y
in view of
certification,
obligation of
responsible official
bodies to submit
samples to
laboratories officially
accepted by them,
but no requirements
on ‘acceptance ‘
407
N
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Official
laboratories
(Article 37 to
42)
Y
Limited
400
, no
requirement on
designation or
accreditation
of similar to
the OCR
Y
Limited
401
, no
requirement of
designation or
accreditation
similar to the
OCR
N
Y
Limited
402
, no
requirement of
designation or
accreditation
similar to the
OCR
Y
Limited
403
, no
requirement of
designation or
accreditation
similar to the
OCR
N
404
Y
Limited
405
, no
requirement of
designation or
accreditation
similar to the
OCR
N
Y
Partly included–- but
minimal, laboratories
where samples are
analysed should
have "suitable
facilities and
expertise"
Y
Responsible
official body to
accredit
laboratories after
verification of
compliance +
implementing
powers
406
N
Risk based
import controls
(Article 43 OCR)
N
N
N
N
N
N
N
N
N
N
N
398
Article 2(k), second subparagraph: «The bodies referred to above may, in accordance with their national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to
any legal person, whether governed by public or by private law, which, under its officially approved constitution, is charged exclusively with specific public functions, provided that such person, and its members, has no personal
interest in the outcome of the measures it takes.».
399
Article 2(k), third subparagraph.
400
Article 2(3)(b), limited, in the form of provisions on official seed testing in the framework of examination under official supervision with no further specifications/requirements.
401
Provisions on official seed testing in the framework of examination under official supervision, with no further requirements.
402
Provisions on official seed testing in the framework of examination under official supervision, with no further requirements.
403
Provisions on official seed testing in the framework of examination under official supervision, with no further requirements.
404
There are no rules on seed testing.
405
Provisions on official seed testing in the framework of examination under official supervision, with no further requirements.
406
Provisions on official seed testing in the framework of examination under official supervision, with no further requirements (Article 6(2)).
407
Annex IV of Implementing Directive 2014/98.
153
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
N
N
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
N
411
N
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
N
413
N
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
N
414
N
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
N
415
N
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
N
N
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
N
N
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
N
N
Import controls
(Art. 43 to 64)
Actions in the
event of non-
compliance of
animals and
goods entering
the Union (Art.
65 to 76)
Approval of the
pre-export
controls (Art. 73
and 74)
Cooperation
between
authorities in
N
408
N
N
409
N
N
410
N
N
412
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
The general requirement of ‘random checks’ on marketing applies. There is also a requirement on supply of certain information during the marketing of quantities ˃2kg of seed imported from TCs (Art. 19(2)).
The general requirement of ‘random checks’ on marketing applies. There is also a requirement on supply of certain information during the marketing of quantities ˃2kg of seed imported from TCs (the particulars are: species;
variety; category; country of production and official inspection authority; country of dispatch; importer; quantity of seed).
410
The general requirement of ‘random checks’ on marketing applies. There is also a requirement on supply of certain information during the marketing of quantities ˃2kg of seed imported from TCs (the particulars are: species;
variety; category; country of production and official inspection authority; country of dispatch; importer; quantity of seed - Article 25(2)).
411
The general requirement of ‘random checks’ on marketing applies. No specific rules on import controls, with the exception of the requirement on supply of certain information during the marketing of quantities ˃2kg of seed
imported from TCs (Article 39(2)).
412
The general requirement of ‘random checks’ on marketing applies. No specific rules on import controls, with the exception of the requirement on supply of certain information during the marketing of quantities ˃2kg of seed
imported from TCs Article 23(2)).
413
The general requirement of ‘random checks’ on marketing applies. No specific rules on import controls, with the exception of the requirement on supply of certain information during the marketing of quantities ˃2kg of seed
imported from TCs (Article 22(2)).
414
No specific rules on import controls, with the exception of the requirement on supply of certain information to the competent authorities during the marketing of propagating material imported from a third country (Article
11(2)).
415
See however Article 11(3) (obligation of importer to notify the responsible official bodies of material imported under Article 11(2) and to keep documentary evidence of his contract with the supplier in the third country) and
implementing powers in Article 11(4) for rules on the procedure to be followed and further requirements to be met by importers.
408
409
154
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
relation to
consignments
from TCs (Art.
75 and 76)
Financing of
official controls
by the Member
States (Art. 78
to 85)
Official
certification
426
N
416
N
417
N
N
418
N
419
N
420
N
421
N
422
N
423
N
424
N
425
N
N
427
N
428
N
N
429
N
430
N
431
N
432
N
433
N
N
N
434
Y
435
416
417
There are provisions in relation to EU contribution to Community comparative tests and trials.
Ibidem.
418
Ibidem.
419
Ibidem.
420
Ibidem.
421
Ibidem, Article 23.
422
Ibidem, Article 16(4) and (5).
423
Ibidem, Article 14(5) and (6).
424
Ibidem, Article 20(5) and (6).
425
Ibidem, Article 14(5) and (6).
426
General requirements, signature and issuance, guarantees of reliability of certificates, implementing powers.
427
The rules referring to official certification in the Directive qualify as rules on ‘official attestations’ within the meaning of the OCR; ‘official label’ in the Directive qualifies as an ‘official attestation’ within the meaning of the
OCR See definition of ‘official attestation’ in Article 3(28) of the OCR and Article 91 of the OCR. There is no requirement of the ‘official label’ to be signed by a certifying office.
428
Ibidem.
429
Ibidem.
430
Ibidem.
431
Ibidem.
432
Ibidem.
433
Ibidem.
434
Ibidem.
435
Master certificate for all reproductive material derived from approved basic material (Article 12) and model thereof (Annex VIII).
155
 kom (2023) 0414 - Ingen titel
2733822_0157.png
OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
(Art. 3(25) and
(26), Art. 87 to
90)
Official
attestations
(Art. 3(28) and
91)
Y
436
no
requirements
comparable to
Article 91
(2)(a), (3) and
(4) of the
OCR.
Y
437
no
requirements
comparable to
Article 91
(2)(a), (3) and
(4) of the
OCR.
N
no
requirements
comparable to
Article 91
(2)(a), (3) and
(4) of the
OCR.
Y
438
no requirements
comparable to
Article 91 (2)(a),
(3) and (4) of the
OCR.
Y
439
no
requirements
comparable to
Article 91
(2)(a), (3) and
(4) of the
OCR.
Y
440
no requirements
comparable to
Article 91 (2)(a),
(3) and (4) of the
OCR.
Y
441
no
requirements
comparable to
Article 91
(2)(a), (3) and
(4) of the
OCR.
Y
442
no requirements
comparable to
Article 91 (2)(a),
(3) and (4) of the
OCR.
N
N
Y
443
no requirements
comparable to
Article 91(2)(a), (3)
and (4) of the OCR.
N
436
Seed must be officially certified in order to be placed on the market and packages of basic seed and certified seed must be labelled on the outside with an official label (Article 10(1)(a))and contain an official document (Article
10(1)(b)).
437
Seed must be officially certified in order to be placed on the market (Article 3(1) : “Member States shall provide that cereal seed may not be placed on the market unless it has been officially certified as ‘basic seed’, ‘certified
seed’, ‘certified seed, first generation’ or ‘certified seed, second generation’.”). Packages of basic seed and certified seed must be labelled on the outside with an official label (Article 10(1)(a)) and contain an official document
(Article 10(1)(b))
.
438
Seed must be officially certified in order to be placed on the market (Article 3(1) : “Member States shall provide that cereal seed may not be placed on the market unless it has been officially certified as ‘basic seed’, ‘certified
seed’, ‘certified seed, first generation’ or ‘certified seed, second generation’.”). Packages of basic seed and certified seed must be labelled on the outside with an official label (Article 12(a)) and contain an official document (Article
12(b)).
439
MS shall provide that seed of industrial chicory may not be placed on the market unless it has been officially certified as ‘basic seed’ or ‘certified seed’ (Article 20(1)); MS shall provide that seed of other vegetable species may
not be placed on the market unless it has been officially certified as ‘basic seed’ or ‘certified seed’, or is standard seed (Article 20(2)). Packages of basic seed and certified seed must be labelled on the outside with an official label
(Article 28(1)(a)) and contain an official document (Article 28(1)(b)). Vegetable seed may no be certified, verified as standard seed and marketed unless the variety is officially accepted in one or more Member States (Article 3(1)).
440
Seed potatoes may not be placed on the market unless they have been officially certified as ‘basic seed potatoes’ or ‘certified seed potatoes’ (Article 3(1)). Packages and containers of basic seed potatoes and certified seed
potatoes must be labelled on the outside with an official label (Article 13(1)(a)) and contain an official document (Article 13(1)(a)).
441
Seed may not be placed on the market unless they have been officially certified (Article 3(1) to (3)). Packages of basic seed, certified seed of all categories and commercial seed must be labelled on the outside with an official
label (Article 12(1)(a)) and contain an official document (Article 12(1)(b)).
442
Propagating material may not be placed on the market unless it has been officially certified as ‘initial propagating material’, ‘basic propagating material’ or ‘certified propagating material’ (Article 3(1)(a)). MS to require that an
official label in one of the official languages of the Community, conforming to the specification in Annex IV, be affixed on the outside of packages and bundles of propagating material (Article 10(1)). All conditions applicable to
the official labelling and plant passports are defined and must be recognised as equivalent (Article 10(4)).
443
Requirement of official certification of material and fruit plants for placing on the market (Article 3(1)).
156
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Reference
laboratories
and reference
centres (Art. 92
to 101)
Administrative
assistance and
N
N
N
N
N
N
N
N
N
N
N
N
Y
Very limited
444
Y
Very limited
445
Y
Limited
446
Y
Very limited
447
Y
Limited
448
.
N
Y
Very limited
449
Y
Limited
450
N
Y
Limited
451
Y
Limited
452
Y
Detailed rules on
444
445
MS making use of a specific derogation are required to "assist each other administratively as regards inspection".
MS to assist each other administratively as regards inspection in case they make use of the derogation to authorize official certification and marketing although not all applicable conditions are met (Article 4(4)).
446
Implementing powers for administrative assistance in relation to growing trials (Art. 7(2)(c)). Notification to the other MS and to the Commission of any application or withdrawal of an application for acceptance of a variety,
any entry in a catalogue of varieties as well as any amendment (Article 10(1)). Where maintenance takes place in a Member State other than the one in which the variety was accepted, the Member States concerned shall assist each
other administratively as regards verification (Art. 11(4)).
447
MS to assist each other administratively as regards inspection in case they make use of the derogation to authorize official certification and marketing although not all applicable conditions are met (Article 5, last subparagraph).
448
Where maintenance of accepted varieties takes place in a MS other than that in which the variety was accepted, the MS concerned shall assist each other administratively as regards checks (Article 11(4)). Notification obligations
to other MS and the Commission in relation to accepted varieties (Article 10).
449
MS to assist each other administratively as regards inspection in case they make use of the derogation to authorize official certification and marketing although not all applicable conditions are met (Article 5).
450
MS to immediately communicate to the other MS ad the Commission all applications or withdrawals of applications for acceptance of a variety, entries in a catalogue of varieties and amendments made to it (Article 5e(2)). In
case maintenance of a variety for conservation is carried out in a MS other than that in which the variety was accepted, MS in question to assist each other administratively as regards control (Article 5g(4)).
451
In the form of obligation of the MS to notify to the Commission and to the competent national authorities in the MS if a supplier is forbidden to market vegetable propagating and planting material (Article 19(2)).
452
In the form of obligation of the MS to notify to the Commission and to the competent national authorities in the MS if a supplier is forbidden to market propagating material and fruit plants (Article 16(3)).
157
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
administrative
assistance
453
+
communication to
Commission and
other MS
454
N
N
cooperation
(Art. 102-108)
Planning (Art.
109- 111)
Reporting to
the
Commission
(Art. 113 )
Coordinated
control
programmes
and information
and data
collection
(Art.112 OCR)
N
N
N
Y
455
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
Y
Data collection
in the form of
Community
comparative
tests and
trials
456
Y
Data collection
in the form of
Community
comparative
tests and trials
shall be
carried
457
.
N
Y
Data collection in
the form of
Community
comparative tests
and trials
458
.
Y
Data collection
in the form of
Community
comparative
tests and
trials
459
.
Y
Data collection in
the form of
Community
comparative tests
and trials
460
Y
Data collection
in the form of
Community
comparative
tests and
trials
461
.
Y
Data collection in
the form of
Community
comparative tests
and trials
462
.
Y
Data collection in
the form of
Community
comparative tests
and trials
463
Y
Data collection in
the form of
Community
comparative tests
and trials
464
Y
Data collection in
the form of
Community
comparative tests
and trials
465
N
453
Article 16(2) and Commission Regulation (EC) No
1598/2002
of 6 September 2002 laying down detailed rules for the application of Council Directive 1999/105/EC as regards the provision of mutual administrative assistance
by official bodies. MS to ensure that the respective official bodies assist each other administratively in order to obtain appropriate information necessary to ensure the proper functioning of this Directive, particularly where FRM
moves from one Member State to another (Art.16(2)).
454
MS to communicate to the Commission and to the other MS maps showing the demarcations of the regions of provenance of basic material intended for the production of reproductive material of the "source-identified" and
"selected" categories (Art. 9(2)). A national list of the basic material of the various species approved on its territory shall be drawn up by each Member State and shall be available on request to the Commission and the other
Member States (Art. 10(2)).
455
Reporting obligation until 28 February 2030 for the responsible certification authority to the Commission and the other MS (Annex I, 5b, last subparagraph).
456
Article 20. See also 2004/11/EC: Commission Decision of 18 December 2003 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain plants of agricultural and
vegetable species and vine under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC for the years 2004 and 2005 (Text with EEA relevance) (notified
under document number C(2003) 4836) (OJ L 3, 7.1.2004, p. 38); Commission Decision of 27 December 2004 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain
plants of agricultural and vegetable species and vine under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC for the years 2005 to 2009 (notified under
document number C(2004) 5264) (Text with EEA relevance) (2005/5/EC)( (OJ L 002, 5.1.2005, p.12).
457
Article 20.
158
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2733822_0160.png
OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
N
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
N
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
N
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
N
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Y
466
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Y
467
as a possibility
(‘may’)
N
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Y
As a possibility
(‘may’)
468
N
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Y
As a possibility
(‘may’)
469
N
Commission
controls in MS
(Art. 116 to 119)
Commission
controls in the
TCs (Art. 120 to
124)
N
N
N
N
N
N
N
N
N
N
N
N
N
458
459
Article 26(2).
Article 43.
460
Article 20.
461
Article 23(2).
462
Article 16(2).
463
Article 14.
464
Article 20(2). The Commission to inform the PAFF committee of the results.
465
Article 14.
466
Article 14(1): “1. Where appropriate, trials or tests shall be carried out in the Member States on samples to check that propagating material complies with the requirements and conditions of this Directive. The Commission may
organise inspections of trials by representatives of the Member States and of the Commission.”
467
On the spot checks, in particular to verify compliance by the suppliers, but as a possibility, not as an obligation + implementing powers (Article 7). Inspections of the trials, but as a possibility (Article 20(1): The Commission
may organise inspections of the trials by representatives of the Member States and of the Commission).
468
The Commission may organise inspections of the trials by representatives of the MS and of the Commission (Article 14(1)). On the spot checks, in particular to verify compliance by the suppliers, but as a possibility, not as an
obligation and implementing powers (Article 15).
469
Article 16(5): “Experts from the Commission may, in cooperation with the official bodies of the Member States, make on-the-spot checks so far as this is necessary to ensure uniform application of this Directive. They may in
particular verify whether FRM is complying with the requirements of this Directive. A Member State in whose territory a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The
Commission shall inform the Member States of the results of the investigation”.
159
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
N
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Y
Only officially
certified seed
may be placed
on the EU
market
473
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Y
Only officially
certified seed
may be placed
on the EU
market
475
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Y
Only officially
certified seed
may be placed on
the EU market
Pending
equivalence
decisions, MS are
authorised to take
such decisions
476
.
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Y
Pending
equivalence
decision, import is
prohibited except
where the importer
provides assurances
477
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Y
By MS, pending
an equivalence
decision by the
Commission
478
.
Import
conditions, (Art.
125 to 128)
Y
Only officially
certified seed
may be placed
on the EU
market
470
Y
Only officially
certified seed
may be placed
on the EU
market
471
Y
Only officially
certified seed
may be placed on
the EU market
472
Y
Only officially
certified seed
may be placed on
the EU market
474
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Y
By MS, pending an
equivalence
decision by the
Commission
479
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Y
By Council acting
on a proposal
from the
Commission
480
By MS, pending
an equivalence
decision by
Council
481
470
471
Article 3.
Article 3(1) OCR. There are specific rules on official certification in MS of cereal seed harvested in a TC in Article 15(3).
472
Article 3(1). Specific rules on official certification in MS of cereal seed harvested in a TC (Article 22(3)).
473
There are also specific rules on official certification in MS of cereal seed harvested in a TC.
474
Article 3(1).
475
Article 3. There are also rules concerning official certification of seed harvested in a TC (Article 19(3)) and of seeds produced from seeds officially certified in a TC which has been granted equivalence (Article 19(1)).
476
Article 15(2)(c).
477
Article 11(2) and (3).
478
MS importing such material from TCs may, until 31 December 2022, apply to such products import conditions at least equivalent to those applicable to similar Union products (Article 16(2) and Commission Implementing
Decision (EU)
2022/1400
of 11 August 2022 amending Council Directive 2008/72/EC to extend the period during which Member States may decide on the import conditions for vegetable propagating and planting material, other
than seed, from third countries (notified under document C(2022) 5723) (OJ L 213, 16.8.2022, p. 57)).
479
MS importing such material from TCs may, until 31 December 2022, apply to such products import conditions at least equivalent to those established pursuant to Article 4 (Article 12(2) and Commission Implementing Directive
2014/97/EU).
480
In addition to the equivalence decision, Council is to determine the species, type of basic material and categories of FRM, together with its region of provenance, which may be permitted to be marketed within the Union (Article
19(2)).
481
Article 19(3) and Commission Implementing Decision (EU) 2021/773 of 10 May 2021 authorising Member States, in accordance with Council Directive 1999/105/EC, to temporarily decide on the equivalence of FRM of certain
categories produced in certain third countries (notified under document C(2021) 3194)
C/2021/3194 (OJ L 169, 12.5.2021, p. 1). Master certificate or official certificate to be issued by the TC of origin.
160
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
Y
485
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Y
487
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Y
489
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
Y
490
.
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
Y
491
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
Y
492
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
Y
493
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
Y
494
Equivalence TC
requirements
(Art. 129)
EU training of
staff (BTSF)
(Art. 130)
Y
482 483
Y
484
Y
486
Y
488
.
N
N
N
N
N
N
N
N
N
N
N
N
482
483
Recognition by Council acting by a qualified majority on a proposal from the Commission of equivalence of field inspection and of seed (Article 16).
competence of the COM to adopt such measures; conditions for the granting of equivalence; implementing powers to set out the practical arrangements for the entry into the Union of such goods.
484
Recognition by Council, acting by a qualified majority on a proposal from the Commission of equivalence of field inspection and of seed.
485
Recognition by Council, acting by qualified majority, on a proposal from the Commission, that official examinations of varieties carried out in the TC afford the same assurances as those provided for in Article 7 and carried out
in the Member States; the checks on practices for the maintenance of varieties carried out in the third country afford the same assurances as those carried out by the Member States (Article 22).
486
Recognition by Council, acting by a qualified majority on a proposal from the Commission. See Council Decision 2003/17/EC of 16 December 2002 on the equivalence of field inspections carried out in third countries on seed-
producing crops and on the equivalence of seed produced in third countries (Text with EEA relevance) (OJ L 008 14.1.2003, p. 10).
487
Recognition by Council, acting by a qualified majority on a proposal from the Commission official examinations of varieties, checks on practices for the maintenance of the varieties, of field inspections, of
vegetable seed harvested in a third country (Article 37(1)).
488
Recognition by Council, acting by a qualified majority on a proposal from the Commission that seed potatoes harvested in a third country are equivalent to basic seed potatoes or certified seed potatoes harvested within the
Community and complying with the provisions of this Directive (Article 21(1)).
489
Recognition by Council, acting by a qualified majority on a proposal from the Commission of equivalence of field inspections and of seed of oil and fibre plants.
490
Determination by Council, acting by a qualified majority on a proposal from the Commission whether material for the vegetative propagation of the vine produced in a TCs offers, as regards the conditions for its acceptance and
the measures taken to ensure its production with a view to its marketing, the same guarantees as material produced in the Community and meets the requirements of the Directive (Article 15(2)(a)). Determination of the types of
material and the categories of material for the vegetative propagation of the vine that may be admitted to marketing within the territory of the Community under equivalence (Article 15(2)(b)).
491
By the Commission Implementing Acts on equivalent guarantees of propagating material produced in a TCs in all respects to material produced in the Community in accordance with this Directive (Article 11(1)).
492
In Commission implementing acts, decision whether vegetable propagating and planting material produced in a third country is equivalent to vegetable propagating and planting material produced in the Community and
complying with the requirements and conditions of this Directive (Article 16(1)).
493
In Commission implementing acts, decision whether propagating material and fruit plants produced in a third country is equivalent to material/plants produced in the Community and complying with the requirements and
conditions of the Directive (Article 12(1)).
494
Recognition by Council acting by a qualified majority on a proposal from the Commission that FRM provides the same assurances as regards the approval of its basic material and the measures taken for its production with a
view to marketing as does FRM produced within the Union and complying with the provisions of this Directive (Art. 19(1)).
161
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
N
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
N
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
N
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
N
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
N
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
N
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
N
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
N
Information
management
system (Art.
131 to 136)
Enforcement
action (Art. 137
and 138)
N
N
N
N
Y
Limited
N
Y
495
Y
Y
496
Y
Limited
497
Y
Limited
498
Y
Limited
499
.
Y
appropriate
measures in relation
to material
500
and to
the particular
supplier
501
+
withdrawal of
measures
502
Y
503
Y
in relation to non-
compliant material
504
and to non-
compliant
suppliers
505
Y
Limited
506
495
496
Revocation of acceptance of variety (Art. 14) and its deletion (Art. 15).
Member States shall ensure that any doubts which arise after the acceptance of a variety concerning the appraisal of its distinctness or of its name at the time of acceptance are removed and related implementing powers (Article
13). Replacement or revocation of acceptance of a variety (Article 13(2) and 14) and deletion (Article 15). Adaptation of the name of an accepted variety (Article 13 (3)). MS to prohibit marketing of seeds in case of repeated non-
compliance found during post-control tests carried out in the field (Article 42(1)). MS shall ensure that any certification of the seed sampled is annulled in the event of contravention unless it can be shown that such seed still meets
all relevant requirements (Article 25(1a)(f)).
497
Sorting of seed potatoes which do not, during marketing, satisfy the minimum conditions laid down in Annex II (Article 3(1).
498
Only in relation to examination under official supervision, MS to ensure that any certification of the seed sampled is annulled in the event of contravention unless it can be shown that such seed still meets all relevant
requirements (Article 2(5)(A)(e) ; Article 2(5)(B)(f)).
499
Revocation of acceptance of varieties and deletion from the catalogue if any of the conditions for acceptance for certification or checking is no longer satisfied (Article 5e(1)).
500
Article 13(1) : «If, during official inspections referred to in Article 12, or the trials referred to in Article 14, it is found that propagating material does not meet the requirements of this Directive, the responsible official body shall
ensure that the supplier takes appropriate corrective action or, if that is not possible, shall prohibit the marketing of that propagating material in the Community.”
501
Article 13(2) : « If it is found that propagating material marketed by a particular supplier does not comply with the requirements of this Directive, the Member State concerned shall ensure that appropriate measures are taken in
relation to that supplier.”
502
Article 13(3) : « 3. Any measures taken under paragraph 2 shall be withdrawn as soon as it has been established with sufficient certainty that the propagating material intended for marketing by the supplier will, in future,
comply with the requirements and conditions of this Directive.”
503
The responsible official body must take appropriate action in case official controls reveal non-compliance (Article 6(4) last subparagraph), including in relation to accreditation of suppliers and laboratories (Article 6(3)). MS
shall take appropriate action to ensure that: non-compliant material does comply or, if that is not possible, to ban its marketing in the Community (Article 19(1)) and take appropriate measures against the supplier (Article 19(2)).
MS to take appropriate official measures to eliminate any plant health risk (Article 23(2)).
504
Article 16(2).
505
Article 16(3).
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OCR
requirements
PRM and FRM Directives
Directive
66/401/EEC
–
marketing of
fodder plant
seed
Directive
66/402/EEC
–
marketing of
cereal seed
Directive
2002/53/EC
–
common
catalogue of
agricultural
plant species
N
Directive
2002/54/EC
–
marketing of
beet seed
Directive
2002/55/EC
–
marketing of
vegetable
seed
Y
Limited
510
N
Directive
2002/56/EC
–
marketing of
seed potatoes
Directive
2002/57/EC
–
marketing of
seed of oil
and fibre
plants
Y
511
Directive
68/193/EEC
–
marketing of
material for the
propagation of
the vine
N
Directive
1998/56/EC
–
marketing of
propagating
material of
ornamental plants
N
Directive
2008/72/EC
–
marketing of
vegetable
material, other
than seed
N
Directive
2008/90/EC
–
marketing of fruit
propagating
material and fruit
plants for fruit
production
N
Directive
1999/105/EC
–
marketing of
forest
reproductive
material
N
Penalties (Art.
139(1))
Penalties for
violations
through fraud
(Art. 139(2))
Whistle blowing
(Art. 140)
EU enforcement
measures (Art.
141)
Y
Limited
507
N
Y
Limited
508
N
Y
Limited
509
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
Y
512
N
N
N
N
N
N
N
N
N
N
N
N
506
507
Withdrawal of approval of basic material (Art. 4(3)(a)).
Only in relation to penalties applicable to infringements of the national provisions governing examination under official supervision and the focus is on infringements by field inspectors, seed testing laboratories, and not on
infringements by the operators. Also, there are no rules on notification to the Commission of these rules, similar to those in the OCR.
508
Ibidem.
509
Ibidem.
510
Ibidem.
511
Ibidem (Article 2(5)(A)(e) ; Article 2(5)(B)(f).
512
Prohibition of the marketing of seed potatoes harvested in a particular area of the Union in case of non-compliance for 3 consecutive years in Community tests and trials (Article 20(7) and (8)).
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9.2.
Information on official controls from consultation activities
9.2.1.
Controls on operators carrying out certification under official
supervision
Just under half of responding NCAs (N=25) reported that they carry out controls on certification
under official supervision.
Figure 10. Overview of responses to the question ‘Do you currently carry out controls of certification activities
under official supervision? (N=25)
9.2.2.
PRM import controls
Percentage of
consignments checked
Less than 10%
10-25%
26-50%
51-75%
over 75%
I don't know
PRM
3
2
2
1
6
3
FRM
3
0
0
0
3
2
Table 31. Overview of controls on imported PRM/FRM consignments to check the identity of
PRM/FRM on an annual basis
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9.2.3.
Types of import controls:
Figure 11. Overview of the type of import controls (N=3-22) and the relative proportion (%) in relation to the
total number of imports. Responses to other (N=3): not responsible, post-controls depend on another NCA, all
pre-basic and basic PRM of agricultural crops is checked in grow out plots.
Figure 12. Overview of criteria used for carrying out documentary checks (N=22).
9.2.4.
Controls on operators at production stage of PRM/FRM
The estimated total number of controls that NCAs carry out on operators at production stage on an
annual basis, varied significantly from a few times a year to 1 000. However, the type of control
varied which may explain the variation in responses. Similar to the import control checks operators
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at the production stage are also most frequently undergoing documentary checks and visual
inspections while pest control tests are the least frequent.
Figure 13. Overview of types of controls on operators at production stage of PRM/FRM? (N=25)
Figure 14. Overview of the type of controls on operators at production stage of PRM/FRM (N=7-22) and the
percentage of operators checked at production stage. Responses to other (N=7): interview, soil and plant material
sampling & testing, sampling and testing of plants other than seed, GMO tests where applicable, the answer is all
regarding the certification of seed, N/A, it is not clear which type of control is involved.
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Figure 15. Overview of criteria used for carrying out documentary checks (N=23).
9.2.5.
PRM marketing controls
Figure 16. Overview of the type of PRM/FRM marketing controls (N=4-23) and the percentage of PRM/FRM
checked during marketing.
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Figure 17. Overview of criteria used for carrying out documentary checks (N=23).
168
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10. F
URTHER DETAILS ON OPTION
2 (
PREFERRED OPTION
)
10.1.
Current and potential future approach for variety registration and PRM
certification
Figure 18. Schematic representation of the current and potential future approach for variety registration and PRM
certification under policy option 2
The upper part of Figure 18 shows the current legal framework. The lower part shows the potential
future approach for variety registration and certification based on the preferred policy option of this
impact assessment, namely option 2. Under the current legal framework, DUS testing and VCU
examination in the case of agricultural species, seed potatoes and vine is a condition for variety
registration. As regards the VCU examination, MS can decide which characteristics of the VCU
examination they deem to be important. In practice, the VCU examination is mainly focussed on
yield while limited attention is given to the assessment of characteristics contributing to sustainable
production. PRM of registered varieties is certified as pre-basic, basic or certified material or meets
the requirements of standard or
Conformitas Agraria Communitatis
(CAC) material. PRM is
marketed under one of those 4 categories.
Derogations from the DUS testing requirement for variety registration have been introduced
through the legislation on conservation varieties (including landraces). The intention of these
derogations was to increase the diversity of PRM available on the market, but a limited number of
conservation varieties has been authorised for marketing. The PRM concerned is not certified. It is
marketed with a label issued by the operator that mentions the type of variety.
The current legislation has limited possibilities as regards the conservation and sustainable use of
plant genetic resources because transfer of PRM is considered as marketing. This implies that the
activities of seed conservation networks and the exchange in kind of PRM between farmers fall
within the scope of the marketing legislation. The varieties concerned have to be officially
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registered and the PRM certified and marketed as pre-basic, basic or certified or the PRM meets the
requirements to be marketed as standard/Conformitas
Agraria Communitatis
(CAC) material.
Under the future legal framework, the variety registration and certification pillars will remain but in
addition there will be a notification procedure for heterogeneous and organic heterogeneous
material and lighter rules for the activities of seed conservation networks and exchange in kind of
seeds between farmers. Under the first pillar of variety registration the existing derogatory regime
for conservation varieties and landraces will be expanded to include new locally adapted varieties.
Lighter rules for the activities of seed conservation networks and exchange in kind of seeds
between farmers will ensure a minimum level of quality and traceability of the PRM concerned.
As regards the second pillar, only PRM of registered varieties will be certified as pre-basic, basic or
certified material or meet the requirements of standard or
Conformitas Agraria Communitatis
(CAC) material. PRM will be marketed under one of those 4 categories. PRM of conservation
varieties and new locally adapted varieties, heterogeneous/organic heterogeneous material, PRM
exchanged by seed conservation networks or farmers will not be subject to certification.
10.2.
Potential future approach for variety registration, activities of seed
conservation networks and exchange in kind of seeds
Figure 19. Schematic representation of the potential future approach for variety registration, activities of seed
conservation networks and exchange in kind of PRM between farmers under policy option 2
Figure 19 describes the potential future approach for variety registration, notification of
heterogeneous/organic heterogeneous material, PRM exchanged by seed conservation networks or
farmers based on the preferred policy option of this impact assessment, namely option 2. Upon
registration of a new conventional or organic variety based on an official description, there will be
an assessment of characteristics contributing to sustainable production (VSCU). Furthermore, the
DUS and VSCU examinations will be adapted to cater for the needs of organic varieties suitable for
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organic production that cannot meet the stringent uniformity requirements applied to conventional
varieties. For varieties of fruit plants and vegetables there will be, instead of the VCU examination,
trials assessing the performance of varieties containing sustainability characteristics in relation to a
number of reference varieties without those sustainability characteristics.
In the case of conservation varieties and new locally adapted varieties, the registration will not
require an official examination but will be based on an officially recognised description. The
notification procedure for heterogeneous and organic heterogeneous material will be based on the
existing notification procedure for organic heterogeneous material
513
. PRM of heterogeneous and
organic heterogeneous material will be allowed for marketing following a notification made by the
breeder to the NCA based on a dossier containing (1) the contact details of the applicant, (2) the
species and the denomination of the heterogeneous/organic heterogeneous material as applicable,
(3) the description of the main agronomic and phenotypic characteristics that are common to that
plant grouping and a declaration by the applicant concerning the truth of the elements in points (1),
(2) and (3). Upon acceptance by the NCA that heterogeneous/organic heterogeneous material will
be listed in a separate section of the EU Plant Variety Portal.
The future legal framework will establish lighter rules for the activities of seed conservation
networks and exchange in kind of PRM between farmers. Any natural or legal person involved in
one of the aforementioned activities cannot have a contractual relationship with a seed company
(e.g. service contract to multiply seed for a seed company). The PRM concerned does not belong to
a variety that is registered in the EU Plant Variety Portal, nor does it belong to a variety protected
by a national or Community plant variety right. MS will lay down species-specific quantitative
restrictions.
10.3.
Value for sustainable cultivation and use (VSCU)
In the future PRM legislation Member States will need to assess the value for sustainable
cultivation and use (VSCU) of candidate varieties of all crop groups. The aim of this examination is
to assess if the characteristics of those candidate varieties, taken as a whole, offer a clear
improvement either for sustainable cultivation or as regards the uses, which can be made of the
crops, other plants or the products derived therefrom. Where other, superior characteristics are
present, individual inferior characteristics may be disregarded. The characteristics, as regards that
examination, would be as appropriate for the species, regions and uses concerned:
a) Yield and yield stability;
b) Tolerance/resistance to biotic stresses including plant diseases caused by nematodes, fungi,
bacteria, viruses, pests;
c) Tolerance/resistance to abiotic stresses, including climate adaptation;
d) Improved utilisation of resources;
e) Enhanced storage performance;
f) Production of substances or characteristics of industrial interest;
g) Quality or nutritional characteristics and characteristics important for processing.
513
Article 13(2) to Regulation (EU) 2018/848. OJ L 150, 14.6.2018, p. 1
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In the future FRM legislation a list of sustainability characteristics will be established in order to
ensure that basic material will have improved performance in relation to one of those listed
characteristics. Even though this list will be established under tertiary legislation, indicatively the
following characteristics would be considered:
a) Suitability of tree species for particular climatic conditions (including conditions under
future climate change projections);
b) Suitability of provenances of basic material for particular climatic conditions (including
conditions under future climate change projections);
c) Adaptability of FRM (e.g. to water stress, drought, heat, cold, wind hoses, wind throws);
d) Resistance of FRM to plant pests.
10.4.
Certification under official supervision
All certification tasks will be permitted under official supervision for all PRM categories (pre-basic,
basic and certified material) and all crop groups. In the case of agricultural species certification
under official supervision will be extended to the pre-basic and basic categories (Figure 20).
Certification under official supervision will also become possible for seed potatoes and vegetables
species
514
.
Figure 20. Official certification and certification under official supervision – agricultural species
514
Certification under official supervision will also apply to Directives 2002/55/EC, 2002/56/EC and 2008/72.
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Figure 21. Official certification and certification under official supervision – Fruit plants and vine
Figure 21 shows a preliminary scheme to conduct certification under official supervision in the case
of fruit plants and vine. The terminology used is slightly different. Reference is made to the
production site or place because the highest category or reproductive material (pre-basic material in
the case of fruit plants and initial propagating material for vine) is produced in insect proof
facilities, but there may be exceptions to this rule. The lower PRM categories are produced under
non-insect proof conditions in the field (fruit plants) and nurseries (vine). Plant health requirements
are an important aspect for the certification of PRM of fruit plants and vine. Compliance with plant
health requirements will be dealt with under the PHL (Annex 6, Section 6.5.). The main part of the
certification scheme will concern the inspection of the production site/place and of the PRM. The
principles of certification under official supervision will be similar to those of seed certification
under official supervision. The operators and their staff may be authorised to conduct certain
activities under official supervision if they are trained and licensed by the NCA. NCAs will
regularly verify that the activities carried out under official supervision are done in a correct way.
NCAs will always approve the production site/place, decide about the certification of PRM and
authorise the issuing of the official labels.
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Figure 22. Official certification and certification under official supervision – FRM
The marketing Directive on FRM implicitly refers to certification under official supervision but
does not specify which activities may be carried out under official supervision
515
. Operators can be
authorised to perform the FRM certification process under the official supervision of the NCAs, as
depicted in Figure 22. This authorisation to conduct certification activities under official
supervision will be subject to the same principles as described above for the seed certification
scheme: training and licensing of operators and OCs on the activities carried out under official
supervision. The following activities will always be carried out officially: the decision to issue the
Master certificate regarding all FRM collected from approved basic material and the authorisation
for the operator to print the supplier’s label/document.
10.5.
Future regulation of RNQPs
1. The current repetition of RNQP requirements in the two legal frameworks (PHL and PRM)
will be abolished.
2. The identification of RNQPs, their thresholds and specific measures will be laid down under
the PHL only.
3. The PRM/FRM legislation will only refer to compliance with PHL requirements as regards
QPs and RNQPs.
4. Compliance with QPs and RNQPs would lead to the issuance of plant passport under plant
health rules.
5. The certification rules under the PRM/FRM legislation will concern the identity and quality
and also require compliance with the plant health rules (QPs and RNQPs).
515
Article 2, point k to Directive 1999/105/EC
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6. The PRM/FRM legislation will make, for the purpose of clarity, a general reference to PHL,
as is already now the case in several marketing Directives.
7. The material shall also comply with the requirements concerning Union quarantine pests,
protected zone quarantine pests and RNQPs provided for in Annex IV to Implementing
Regulation (EU) 2019/2072 as well as the measures in Annex V to that Implementing
Regulation.
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A
NNEX
6: B
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2.
D
OCUMENTS OF THE
E
UROPEAN
C
OMMISSION
COM(2013) 262 final - Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL On the production and making available on the market of plant
reproductive material (plant reproductive material law).
https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=celex:52013PC0262
COM(2019) 640 final - COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN
PARLIAMENT, THE EUROPEAN COUNCIL, THE COUNCIL, THE EUROPEAN ECONOMIC
AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS The European Green
Deal
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2019%3A640%3AFIN
COM(2020) 380 final - COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE
AND THE COMMITTEE OF THE REGIONS EU Biodiversity Strategy for 2030 Bringing nature
back into our lives
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0380
COM(2020) 381 final - COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE
179
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AND THE COMMITTEE OF THE REGIONS A Farm to Fork Strategy for a fair, healthy and
environmentally-friendly
food
system
https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A52020DC0381
COM(2021) 82 final - COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE
AND THE COMMITTEE OF THE REGIONS Forging a climate-resilient Europe - the new EU
Strategy
on
Adaptation
to
Climate
Change
https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=COM%3A2021%3A82%3AFIN
COM(2021)118 final - COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE
AND THE COMMITTEE OF THE REGIONS 2030 Digital Compass: the European way for the
Digital Decade
https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A52021DC0118
COM(2021) 572 final - COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE
AND THE COMMITTEE OF THE REGIONS New EU Forest Strategy for 2030
https://eur-
lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52021DC0572
COM(2021) 786 final - REPORT FROM THE COMMISSION TO THE EUROPEAN
PARLIAMENT AND THE COUNCIL on the enforcement and effectiveness of plant health
measures relating to imports into the Union territory
https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:52021DC0786
SWD(2013) 162 final - COMMISSION STAFF WORKING DOCUMENT IMPACT
ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE
EUROPEAN PARLIAMENT AND OF THE COUNCIL On the production and making available
on the market of plant reproductive material (plant reproductive material law)
https://eur-
lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013SC0162&from=EN
and
https://eur-
lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013SC0163&from=EN
SWD(2013) 0163 final - COMMISSION STAFF WORKING DOCUMENT EXECUTIVE
SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL On the
production and making available on the market of plant reproductive material (plant reproductive
material law)
https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A52013SC0163
SWD(2021)90 final - COMMISSION STAFF WORKING DOCUMENT Study on the Union’s
options to update the existing legislation on the production and marketing of plant reproductive
material
https://data.consilium.europa.eu/doc/document/ST-8287-2021-INIT/en/pdf
SWD(2023) 4 final COMMISSION STAFF WORKING DOCUMENT Drivers of food security.
https://commission.europa.eu/system/files/2023-
01/SWD_2023_4_1_EN_document_travail_service_part1_v2.pdf
3.
EU L
EGISLATION
(
OTHER THAN THAT LISTED IN
S
ECTION
1
OF
A
NNEX
5)
Commission Delegated Regulation (EU) 2021/1189 of 7 May 2021 supplementing Regulation (EU)
2018/848 of the European Parliament and of the Council as regards the production and marketing
180
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of plant reproductive material of organic heterogeneous material of particular genera or species. OJ
L
258,
20.7.2021,
p.
18
https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A32021R1189
Commission Directive 2004/29/EC of 4 March 2004 on determining the characteristics and
minimum conditions for inspecting vine varieties. OJ L 71, 10.3.2004, p. 22
https://eur-
lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32004L0029
Commission Directive 2008/62/EC of 20 June 2008 providing for certain derogations for
acceptance of agricultural landraces and varieties which are naturally adapted to the local and
regional conditions and threatened by genetic erosion and for marketing of seed and seed potatoes
of those landraces and varieties. OJ L 162, 21.6.2008, p. 13
https://eur-lex.europa.eu/legal-
content/EN/ALL/?uri=celex%3A32008L0062
Commission Directive 2009/145/EC of 26 November 2009 providing for certain derogations, for
acceptance of vegetable landraces and varieties which have been traditionally grown in particular
localities and regions and are threatened by genetic erosion and of vegetable varieties with no
intrinsic value for commercial crop production but developed for growing under particular
conditions and for marketing of seed of those landraces and varieties. OJ L 312, 27.11.2009, p. 44
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32009L0145
Commission Directive 2010/60/EU of 30 August 2010 providing for certain derogations for
marketing of fodder plant seed mixtures intended for use in the preservation of the natural
environment.
OJ
L
228,
31.8.2010,
p.
10
https://eur-lex.europa.eu/legal-
content/EN/ALL/?uri=CELEX%3A32010L0060
Commission Implementing Decision 2012/340/EU of 25 June 2012 on the organisation of a
temporary experiment under Council Directives 66/401/EEC, 66/402/EEC, 2002/54/EC,
2002/55/EC and 2002/57/EC as regards field inspection under official supervision for basic seed
and bred seed of generations prior to basic seed. OJ L 166, 27.6.2012, p. 90.
https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02012D0340-20170705
Commission Implementing Decision 2014/150/EU of 18 March 2014 on the organisation of a
temporary experiment providing for certain derogations for the marketing of populations of the
plant species wheat, barley, oats and maize pursuant to Council Directive 66/402/EEC. OJ L 82,
20.3.2014, p. 29.
https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32014D0150
Commission Implementing Decision (EU) 2020/1106 of 24 July 2020 on the organisation of a
temporary experiment under Council Directives 66/401/EEC, 66/402/EEC,2002/54/EC and
2002/57/EC as regards the official checking rate for field inspection under official supervision for
basic seed, bred seed of generations prior to basic seed and certified seed. OJ L 242, 28.7.2020, p.
7.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32020D1106
Commission Implementing Directive 2014/98/EU of 15 October 2014 implementing Council
Directive 2008/90/EC as regards specific requirements for the genus and species of fruit plants
referred to in Annex I thereto, specific requirements to be met by suppliers and detailed rules
concerning official inspections. OJ L 298, 16.10.2014, p. 22
https://eur-lex.europa.eu/legal-
content/en/ALL/?uri=CELEX:32014L0098
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Commission Implementing Directive (EU) 2021/971 of 16 June 2021 amending Annex I to Council
Directive 66/401/EEC on the marketing of fodder plant seed, Annex I to Council Directive
66/402/EEC on the marketing of cereal seed, Annex I to Council Directive 2002/54/EC on the
marketing of beet seed, Annex I to Council Directive 2002/55/EC on the marketing of vegetable
seed and Annex I to Council Directive 2002/57/EC on the marketing of seed of oil and fibre plants,
as regards the use of biochemical and molecular techniques. OJ L 214, 17.6.2021, p. 62
https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021L0971
Commission Implementing Directive (EU) 2022/1647 of 23 September 2022 amending Directive
2003/90/EC as regards a derogation for organic varieties of agricultural plant species suitable for
organic production. OJ L 248, 26.9.2022, p. 46
https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=uriserv%3AOJ.L_.2022.248.01.0046.01.ENG&toc=OJ%3AL%3A2022%3A
248%3ATOC
Commission Implementing Directive (EU) 2022/1648 of 23 September 2022 amending Directive
2003/91/EC as regards a derogation for organic varieties of vegetable species suitable for organic
production.
OJ
L
248,
26.9.2022,
p.
52
https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=uriserv%3AOJ.L_.2022.248.01.0052.01.ENG&toc=OJ%3AL%3A2022%3A
248%3ATOC
Commission Implementing Regulation (EU) 2019/2072 of 28 November 2019 establishing uniform
conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and
the Council, as regards protective measures against pests of plants, and repealing Commission
Regulation (EC) No 690/2008 and amending Commission Implementing Regulation (EU)
2018/2019. OJ L 319, 10.12.2019, p. 1
https://eur-lex.europa.eu/eli/reg_impl/2019/2072/oj
Commission Implementing Regulation (EU) 2022/1372 of 5 August 2022 as regards temporary
measures to prevent the entry into, the movement and spread within, the multiplication and release
in the Union of
Meloidogyne graminicola
(Golden & Birchfield). OJ L 206, 8.8.2022, p. 16
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R1372
Council Decision (EU) 2019/1905 of 8 November 2019 requesting the Commission to submit a
study on the Union’s options to update the existing legislation on the production and marketing of
plant reproductive material, and a proposal, if appropriate in view of the outcomes of the study. OJ
L 293, 14.11.2019, p. 105
https://eur-lex.europa.eu/eli/dec/2019/1905/oj
Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights. OJ L
227, 1.9.1994, p. 1
https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A31994R2100
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the
deliberate release into the environment of genetically modified organisms and repealing Council
Directive 90/220/EEC.
OJ L 106, 17.04.2001, p. 1
https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=celex%3A32001L0018
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September
2003 on genetically modified food and feed. OJ L 268, 18.10.2003, p. 1
https://eur-
lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32003R1829
182
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Regulation (EC) No 138/2004 of the European Parliament and of the Council of 5 December 2003
on the economic accounts for agriculture in the Community OJ L 33, 5.2.2004, p. 1
https://eur-
lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32004R0138
Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on
protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No
652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing
Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and
2007/33/EC.
OJ
L
317,
23.11.2016,
p.
4
https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A32016R2031
Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on
official controls and other official activities performed to ensure the application of food and feed
law, rules on animal health and welfare, plant health and plant protection products, amending
Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU)
No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament
and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council
Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing
Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the
Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC,
96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation). OJ L
95, 7.4.2017, p.1
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32017R0625
Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on
organic production and labelling of organic products and repealing Council Regulation (EC) No
834/2007.
OJ
L
150,
14.6.2018,
p.
1
https://eur-lex.europa.eu/legal-
content/EN/ALL/?uri=CELEX%3A32018R0848
Regulation (EU) 2021/2115 of the European Parliament and of the Council of 2 December 2021
establishing rules on support for strategic plans to be drawn up by MS under the common
agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee
Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and
repealing Regulations (EU) No 1305/2013 and (EU) No 1307/2013. OJ L 435, 6.12.2021, p. 1–186
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02021R2115-20220422
183