kom (2017) 0795 (forslag) - COMMISSION STAFF WORKING DOCUMENT REFIT EVALUATION Accompanying the document Proposal for a Regulation of the European Parliament and of the Council laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council

Europaudvalget 2017
KOM (2017) 0795
Offentligt

EUROPEAN

COMMISSION

Brussels, 19.12.2017

SWD(2017) 469 final

PART 3/3

COMMISSION STAFF WORKING DOCUMENT

REFIT EVALUATION

Accompanying the document

Proposal for a Regulation of the European Parliament and of the Council

laying down rules and procedures for compliance with and enforcement of Union

harmonisation legislation on products and amending Regulations (EU) No 305/2011,

(EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of

the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC,

2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU,

2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU

and 2014/90/EU of the European Parliament and of the Council

{COM(2017) 795 final} - {SWD(2017) 466 final} - {SWD(2017) 467 final} -

{SWD(2017) 468 final} - {SWD(2017) 470 final}

kom (2017) 0795 (forslag) - COMMISSION STAFF WORKING DOCUMENT REFIT EVALUATION Accompanying the document Proposal for a Regulation of the European Parliament and of the Council laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council

NNEX

5: U

NION

(1)

(2)

HARMONISATION LEGISLATION AND

MARKET SURVEILLANCE PROVISIONS

VERVIEW

OF APPLICABLE

NION HARMONISATION LEGISLATION

Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws

of the Member States relating to crystal glass;

Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of

the Member States relating to the permissible sound level and the exhaust system of

motor vehicles;

Council Directive 75/107/EEC of 19 December 1974 on the approximation of the laws

of the Member States relating to bottles used as measuring containers;

Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the

Member States relating to aerosol dispensers;

Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of

the Member States relating to the making-up by weight or by volume of certain pre-

packaged products;

Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws

of the Member States relating to units of measurement and on the repeal of Directive

71/354/EEC;

Council Directive 92/23/EEC of 31 March 1992 relating to tyres for motor vehicles and

their trailers and to their fitting (valid

until 31 October 2017);

Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-

water boilers fired with liquid or gaseous fuels;

Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on

the approximation of the laws, regulations and administrative provisions of the Member

States relating to labelling of the materials used in the main components of footwear for

sale to the consumer;

(3)

(4)

(5)

(6)

(7)

(8)

(9)

(10) Directive 97/68/EC of the European Parliament and of the Council of 16 December

1997 on the approximation of the laws of the Member States relating to measures

against the emission of gaseous and particulate pollutants from internal combustion

engines to be installed in non-road mobile machinery;

(11) Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998

relating to the quality of petrol and diesel fuels and amending Council Directive

93/12/EEC;

(12) Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on

the approximation of the laws of the Member States relating to the noise emission in the

environment by equipment for use outdoors;

(13) Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13

October 2003 relating to fertilisers;

429

(14) Directive 2004/42/CE of the European Parliament and of the Council of 21 April 2004

on the limitation of emissions of volatile organic compounds due to the use of organic

solvents in certain paints and varnishes and vehicle refinishing products and amending

Directive 1999/13/EC;

(15) Directive 2004/52/EC of the European Parliament and of the Council of 29 April 2004

on the interoperability of electronic road toll systems in the Community;

(16) Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10

March 2004 on the interoperability of the European Air Traffic Management network

(the interoperability Regulation);

(17) Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31

March 2004 on detergents;

(18) Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29

April 2004 on persistent organic pollutants and amending Directive 79/117/EEC;

(19) Directive 2005/64/EC of the European Parliament and of the Council of 26 October

2005 on the type-approval of motor vehicles with regard to their reusability,

recyclability and recoverability and amending Council Directive 70/156/EEC;

(20) Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006

relating to emissions from air conditioning systems in motor vehicles and amending

Council Directive 70/156/EEC;

(21) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006

on machinery;

(22) Directive 2006/66/EC of the European Parliament and of the Council of 6 September

2006 on batteries and accumulators and waste batteries and accumulators and repealing

Directive 91/157/EEC;

(23) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18

December 2006 concerning the Registration, Evaluation, Authorisation and Restriction

of Chemicals (REACH), establishing a European Chemicals Agency, amending

Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and

Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and

Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC;

(24) Directive 2007/45/EC of the European Parliament and of the Council of 5 September

2007 laying down rules on nominal quantities for pre-packed products, repealing

Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive

76/211/EEC;

(25) Directive 2007/46/EC of the European Parliament and of the Council of 5 September

2007 establishing a framework for the approval of motor vehicles and their trailers, and

of systems, components and separate technical units intended for such vehicles;

(26) Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June

2007 on type approval of motor vehicles with respect to emissions from light passenger

430

and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and

maintenance information;

(27) Directive 2008/2/EC of the European Parliament and of the Council of 15 January 2008

on the field of vision and windscreen wipers for wheeled agricultural or forestry tractors

(Codified version);

(28) Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008

on the interoperability of the rail system within the Community;

(29) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16

December 2008 on classification, labelling and packaging of substances and mixtures,

amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending

Regulation (EC) No 1907/2006;

(30) Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009

relating to common provisions for both measuring instruments and methods of

metrological control;

(31) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009

on the safety of toys;

(32) Directive 2009/125/EC of the European Parliament and of the Council of 21 October

2009 establishing a framework for the setting of ecodesign requirements for energy-

related products;

(33) Regulation (EC) No 78/2009 of the European Parliament and of the Council of 14

January 2009 on the type-approval of motor vehicles with regard to the protection of

pedestrians and other vulnerable road users, amending Directive 2007/46/EC and

repealing Directives 2003/102/EC and 2005/66/EC;

(34) Regulation (EC) No 79/2009 of the European Parliament and of the Council of 14

January 2009 on type-approval of hydrogen-powered motor vehicles, and amending

Directive 2007/46/EC;

(35) Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June

2009 on type-approval of motor vehicles and engines with respect to emissions from

heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance

information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and

repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC;

(36) Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July

2009 concerning type-approval requirements for the general safety of motor vehicles,

their trailers and systems, components and separate technical units intended therefor;

(37) Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16

September 2009 on substances that deplete the ozone layer;

(38) Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25

November 2009 on the labelling of tyres with respect to fuel efficiency and other

essential parameters;

431

(39) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30

November 2009 on cosmetic products;

(40) Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25

November 2009 on the EU Ecolabel;

(41) Directive 2010/30/EU of the European Parliament and of the Council of 19 May 2010

on the indication by labelling and standard product information of the consumption of

energy and other resources by energy-related products;

(42) Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010

on transportable pressure equipment;

(43) Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27

September 2011 on textile fibre names and related labelling and marking of the fibre

composition of textile products and repealing Council Directive 73/44/EEC and

Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council;

(44) Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on

the restriction of the use of certain hazardous substances in electrical and electronic

equipment;

(45) Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9

March 2011 laying down harmonised conditions for the marketing of construction

products and repealing Council Directive 89/106/EEC;

(46) Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on

waste electrical and electronic equipment (WEEE);

(47) Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22

May 2012 concerning the making available on the market and use of biocidal products;

(48) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5

February 2013 on the approval and market surveillance of agricultural and forestry

vehicles;

(49) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15

January 2013 on the approval and market surveillance of two- or three-wheel vehicles

and quadricycles;

(50) Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013

on the harmonisation of the laws of the Member States relating to the making available

on the market of pyrotechnic articles;

(51) Directive 2013/53/EU of the European Parliament and of the Council of 20 November

2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC;

(52) Directive 2014/28/EU of the European Parliament and of the Council of 26 February

2014 on the harmonisation of the laws of the Member States relating to the making

available on the market and supervision of explosives for civil uses;

432

(53) Directive 2014/29/EU of the European Parliament and of the Council of 26 February

2014 on the harmonisation of the laws of the Member States relating to the making

available on the market of simple pressure vessels;

(54) Directive 2014/30/EU of the European Parliament and of the Council of 26 February

2014 on the harmonisation of the laws of the Member States relating to electromagnetic

compatibility;

(55) Directive 2014/31/EU of the European Parliament and of the Council of 26 February

2014 on the harmonisation of the laws of the Member States relating to the making

available on the market of non-automatic weighing instruments;

(56) Directive 2014/32/EU of the European Parliament and of the Council of 26 February

2014 on the harmonisation of the laws of the Member States relating to the making

available on the market of measuring instruments;

(57) Directive 2014/33/EU of the European Parliament and of the Council of 26 February

2014 on the harmonisation of the laws of the Member States relating to lifts and safety

components for lifts;

(58) Directive 2014/34/EU of the European Parliament and of the Council of 26 February

2014 on the harmonisation of the laws of the Member States relating to equipment and

protective systems intended for use in potentially explosive atmospheres;

(59) Directive 2014/35/EU of the European Parliament and of the Council of 26 February

2014 on the harmonisation of the laws of the Member States relating to the making

available on the market of electrical equipment designed for use within certain voltage

limits;

(60) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014

on the harmonisation of the laws of the Member States relating to the making available

on the market of radio equipment and repealing Directive 1999/5/EC;

(61) Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014

on the harmonisation of the laws of the Member States relating to the making available

on the market of pressure equipment;

(62) Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014

on marine equipment and repealing Council Directive 96/98/EC;

(63) Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16

April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No

842/2006;

(64) Regulation (EU) No 540/2014 of the European Parliament and of the Council of 16

April 2014 on the sound level of motor vehicles and of replacement silencing systems,

and amending Directive 2007/46/EC and repealing Directive 70/157/EEC;

(65) Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March

2016 on cableway installations and repealing Directive 2000/9/EC;

433

(66) Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March

2016 on personal protective equipment and repealing Council Directive 89/686/EEC;

(67) Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March

2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC;

(68) Directive (EU) 2016/802 of the European Parliament and of the Council of 11 May

2016 relating to a reduction in the sulphur content of certain liquid fuels.

VERVIEW OF

MARKET SURVEILLANCE PROVISIONS APPLICABLE TO HARMONISED

PRODUCTS

MARKET SURVEILLANCE PROVISIONS IN EU LEGISLATION

MARKET SURVEILLANCE MEASURES AND

STRUCTURES

REGULATION (EC)

No 765/2008

SECTOR

LEGISLATION

MARKET SURVEILLANCE PROCEDURES

Obligations of economic

surveillance authorities

operators

vis-à-vis

market

Yes

Cases in which obligations of manufacturers apply to

importers and distributors

Identification of economic operators

Definition of formal non-compliance

Procedures for dealing with products presenting a risk at

national level

Market surveillance measures

Products presenting a serious risk

Restrictive measures

Exchange of information

—

Rapid Information System

General information support system (ICSMS)

Union safeguard procedure

Procedure for compliant products which present a risk to

health and safety

Yes

No but legislation

refers to Regulation

(EC) No 765/2008

Yes

MARKET SURVEILLANCE STRUCTURES

General requirements for market surveillance

Information obligations about market surveillance authorities

Obligations of the Member States as regards organisation of

market surveillance

Yes

No but legislation

refers to Regulation

(EC) No 765/2008

434

MARKET SURVEILLANCE PROVISIONS IN EU LEGISLATION

MARKET SURVEILLANCE MEASURES AND

STRUCTURES

Principles of cooperation between the Member States and the

Commission

Sharing of resources

Cooperation with the competent authorities of third countries

Controls of products entering the Union market

Release of products

National measures on products entering the Union market

Financing provisions for market surveillance

Penalties

Yes

Penalties for

economic operators

applicable to

infringements of the

provisions of the

Regulation

Penalties for

economic operators

applicable to

infringements of the

provisions of sector

legislation

REGULATION (EC)

No 765/2008

SECTOR

LEGISLATION

435

NNEX

6: F

EEDBACK ON MARKET SURVEILLANCE IN THE

EU [SWD(2014)23]

HALLENGES FACING MARKET SURVEILLANCE AUTHORITIES

EQ17: What are the main challenges facing market surveillance authorities?

Market surveillance is a Member State responsibility, although the Commission has an

important overall monitoring and coordination role. Effective market surveillance and

regulatory enforcement is a crucial mechanism for ensuring the efficient and effective

implementation of IM legislation for industrial products. It is vital for ensuring product safety

and health and for promoting fair competition and a level playing field among economic

operators. In order to strengthen the current approach to market surveillance, the EU adopted

Regulation 765/2008 setting out common market surveillance rules and the Commission has

proposed a Regulation on Market Surveillance as part of the wider Product Safety and Market

Surveillance Package (PSMSP).

As noted earlier, market surveillance is inherently challenging and is considered by many

stakeholders (e.g. 60.6% of NBs responding to our survey) to be the most problematic part of

the IM regime for industrial products. Indeed, the impact assessment accompanying the

PSMSP highlights a number of challenges, which have also been confirmed by the research

undertaken for this evaluation.

A first challenge is the relatively

high levels of non-compliant products

entering the market,

although instances of non-compliance often relate to minor administrative irregularities rather

than to serious breaches of the essential requirements. There is evidently a balance to be

struck between preventing non-compliant products from entering the market and avoiding the

imposition of unreasonable requirements on responsible economic operators. It is also

reported that there are relatively

few withdrawals of non-compliant products

from the

market, although the RAPEX information systems has helped to raise awareness of high-risk

products. However, the 2006 public consultation on the New Legislative Framework (NLF)

found that 87% of operators considered there to be unfair competition due to the presence of

non-compliant products on the internal market

. Evidence from a number of evaluations and

impact assessments suggests that non-compliant products account for a sizeable share of the

market in certain sectors. This is confirmed in data provided by market surveillance

authorities

For example, the impact assessment

on the proposed “Radio Equipment Directive” to replace

the R&TTE Directive cited evidence from European Market Surveillance Authorities (MSAs)

that presently between as little as an estim ated 28% and 56% of products were fully

compliant with the essential requirements. Administrative compliance has been estimated at

an even lower level by MSAs at about 20%. In the case of the Ecodesign Directive, non-

compliance was estimated to be 10- 20%

In other areas (e.g. Gas Appliances, Personal

protective equipment) the existing studies indicate non-compliance levels of no more than 5-

10%

and there are also cases

–

such as explosives

–

where, according to the relevant

EC (2012), Product Safety and Market Surveillance Package - COMMISSION STAFF WORKING DOCUMENT IMPACT

ASSESSMENT ,

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=swd:2013:0033(51):FIN:EN:PDF

EC (2012), Commission Staff Working Document, Annexes to the Impact Assessment,

http://eur-

lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2013:0033(52):FIN:en:PDF

Proposal for a Directive of the European Parliament and of the Council on the harmonisation of laws of the Member States to the

making available on the market of radio equipment

Evaluation of the Ecodesign Directive (2009/125/EC) - Final Report

Impact assessment study on the review of the Gas Appliances Directive 2009/142/EC

436

evaluation study

, there are very few cases of non-compliance.

However, this is also a possible illustration of authorities giving a higher priority to products

more directly linked to public safety issues. Estimates from market surveillance authorities

and enterprises collected in 2006 also ranged from 1% for recreational craft to 30% for the

Electrotechnical sector and even up to 50% for luminaires. Similar findings were obtained in

three market surveillance campaigns carried out by the Administrative Cooperation group

(ADCO) for the implementation of the Electro-magnetic Compatibility Directive focusing on

Energy Saving Lamps, Power Tools and Consumer Entertainment Electronic Products. The

level of technical non-compliance was 23% for the Energy Saving Lamps, 20% for the Power

Tools and 50% for the Consumer Entertainment Electronic Products while according to the

ADCO machinery NOMAD study around 80% of products do not comply with noise

requirements.

A second challenge, related to the first, is the difficulty in

ensuring the traceability of

products,

which was stressed by a number of interviewees, so that market surveillance

authorities can obtain technical documentation not only at the point when products are placed

on the market but for up to 10 years following their placement on the market. The limited

traceability of products and of manufacturers strongly hinders market surveillance authorities

in carrying out their work and improvements in this area would help to strengthen the

efficiency and effectiveness of MSAs. However, it should be noted that economic operators

were not generally favourable towards traceability requirements, and in particular, were

against the introduction of requirements to register in databases. A major EU industry

association stated that “the manufacturer is already legally responsible for ensuring regulatory

compliance and for producing the DoC to achieve presumption of conformity. Traceability

has become a religion and imposes unnecessary administrative burdens on economic

operators, such as compulsory registration schemes and the requirement to put the address of

the responsible economic operator on the label.”

A market surveillance authority in the

commented that concerns about the administrative

burdens of registration schemes extend beyond industry to some public authorities. “The

proposed new registration scheme under the new R&TTE is intended to improve the

traceability of products. However, it risks causing a bigger divide between good and bad

providers; by creating more hoops to jump through, it will discourage some economic

operators from complying and could also give greater competitive advantage to non-

compliant providers”.

A Product Contact Point in

Sweden

pointed out that, although there has been a lot of

discussion about traceability in the context of the Alignment Package, its value and

importance depends on the type of product concerned, the directive or regulation in question

and whether it is a professional or a consumer product. “When we refer to professional

products where economic operators are known to one another, the extent to which there is

really a need for traceability requirements should be reconsidered since this imposes

unnecessary administrative requirements”.

A third challenge is the

difference in approaches taken to market surveillance in different

countries,

for example, how likely MSAs are to carry out testing themselves, as opposed to

requesting technical information from economic operators. Such differences may undermine

the internal market since there could be variations for economic operators in their

Evaluation on dg enterprise and industry legislation

–

Cosmetics and Explosives Directives

437

experiences, for instance, the type and frequency of requests for information from market

surveillance authorities, the likelihood of having products tested, etc. Different approaches to

market surveillance often reflect different levels of resources and technical expertise available

to MSAs in each country; some stakeholders were of the view that the level of resources and

expertise was insufficient in some countries.

One MSA in

Sweden

noted that “We test a broad selection of products ourselves and do not

only ask manufactures to submit papers on the use of products. We also test a broad selection

of products from different geographic origins both within and outside the EU. We do identify

dangerous products and even where products are generally compliant, remarks are made for

three-quarters

of products tested”. Another MSA in

Romania

noted that market surveillance

needs to be “highly coordinated and capable of reacting rapidly. However, market

surveillance has not kept pace with developments in the Union's regulatory framework, which

could be overcome through the use of an "intelligent" model. This means

that “random

checking” will not be mathematically random, but will instead be focused on a risk-based

approach and the identification of potential problem products and economic operators that

have previously been non-compliant. Wholesalers, distributors etc. who are known by

experience to comply with the rules may therefore expect a fewer inspection visits”.

Encouragingly, stakeholders reported that market surveillance had improved and become

more consistent across different Member States through the measures included in the NLF

and, in particular the common rules on market surveillance set out in Regulation 765/2008.

Some Member States (e.g. Greece, Ireland, Slovenia) had made significant changes to their

market surveillance systems, such as the creation of national market surveillance authorities

and the development of market surveillance programmes, as a direct response to the

requirements of Regulation 765/2008.



Research Findings (RFs)

(RF60) Market surveillance is considered to be the weakest part of the implementation system, partly due

to the inherently difficult nature of the task and in part due to varying levels of resources and technical

expertise available in different countries. (Stakeholder interviews; Survey of NBs)

(RF61) There are high levels of non-compliance for some products, low levels of product withdrawals

and a need to strengthen the traceability of products. However, there is the need for MSAs to differentiate

between minor instances of non-compliance with administrative requirements and serious instances of

non-compliance with essential safety requirements. (Data from previous studies; Stakeholder interviews)

OPERATION

AUTHORITIES

AND INFORMATION SHARING BETWEEN MARKET SURVEILLANCE

EQ18: How effective is the co-operation between market surveillance authorities?

Through the evaluation, we also assessed the extent to which mechanisms and tools put in

place to facilitate cooperation between market surveillance authorities and information

sharing are working effectively, notably the Rapid Alert Information System (RAPEX) and

the “ICSMS” tool (Information and Communication System for Market Surveillance.

Regulation 765/2008 includes a reference in the Regulation to the RAPEX system and has

highlighted the importance of this exchange information mechanism for market surveillance

in the Single Market. The report on the implementation of Regulation 765/2008 provides

feedback on the added value of RAPEX. “Reference to the RAPEX system in the Regulation

438

has extended the obligation to send RAPEX notifications to all goods falling within the scope

of EU harmonisation legislation, including products for use in a professional context (e.g.

industrial machinery) and products which may harm public interests other than health and

safety (e.g. environment, security etc.). This has contributed to the protection of workers and

the environment, although the total number of new notifications has been limited during the

first two years of implementation”.

However, a market surveillance authority in

Ireland

noted that “RAPEX has not led to

many notifications for harmonised products for professional users and the ICSMS has been

more useful in practice”.

Whereas RAPEX was viewed as being useful in informing market

surveillance authorities and the Commission about high-risk products, and the database is

useful for reporting purposes on products presenting serious risks,

ICSMS

, the general

information support system for market surveillance also has an important contribution in

ensuring that there are mechanisms in place for exchanging information between market

surveillance authorities, joint working and for virtual communication and cooperation.

The tool provides a single portal containing information on specific products (product

description, test results, in cases of non-compliance identified any remedial measures taken

etc.). Two of the actions set out in the Multi-annual plan for market surveillance refer to

ICSMS (Action 2: Maximise the benefits of ICSMS and Action 3: Create synergies between

GRAS-RAPEX and ICSMS). A small number of stakeholders referred to ICSMS during the

interview programme.

A market surveillance authority in

Germany

stressed the importance of the need for greater

synergies between RAPEX and ICSMS. “ICSMS is a great operational tool to communicate

with different market surveillance authorities in other EU Member States. Among the

advantages of using the system are that it is available in all languages across EU28.

Documents can be uploaded and although there is no automatic translation of all documents,

most phrases are translated. This solves one of the practical difficulties in ensuring effective

market surveillance - language problems can be a barrier to finding out about dangerous

products and for avoiding duplication of effort between market surveillance authorities in

different countries”.

ICSMS was not seen as duplicating RAPEX but rather complementing it. It was pointed out

that it is only available in EN and it does not provide a tool for communicating and

collaborative working between market surveillance authorities, which ICSMS does.

The need to examine the scope to converge different databases on market surveillance that

feed into Member State reporting requirements to the Commission was highlighted. For

example, a market surveillance authority in

Belgium

noted that “Each year, Member States

have to prepare a report on market surveillance carried out and set out the plan for the

coming year. There are several databases that are useful, such as Circa, RAPEX, ICSMS.

The Commission should investigate whether merging of databases is possible and should

study the value added of each database”.

ICSMS provides an internet-based platform for the comprehensive exchange of information between all the market surveillance

bodies. The tool has an internal area for the use of market surveillance authorities that can also be used by customs authorities and

EU officials.

439



Research Findings (RFs)

(RF62) RAPEX and ISCSMS are viewed as useful in informing market surveillance authorities.

(Interviews of MSAs)

(RF63) There is scope to increase the complementarity and synergy between RAPEX and ISCMS.

(Interviews of MSAs)

ISK

BASED AND SYSTEMS

BASED AUTHORITIES

The proposed Market Surveillance Regulation is based on a risk-based approach to market

surveillance (of both harmonised and non-harmonised products). One of the criticisms made

by stakeholders is that there is no definition in the Regulation of what constitutes risk, and the

criteria to assess it. A market surveillance authority in

Germany

commented that

“Mark

surveillance authorities should focus on checking non-conformity, since this is easier to

perform against the regulatory requirements. If instances of product non-conformity are

identified, and it is judged that these are likely to lead to a risk or to a serious risk, then these

products should be alerted through the RAPEX system.

Although they were in favour of

having common elements in Union harmonisation legislation built into a horizontal

regulation, market surveillance should continue to be based on an assessment of product

compliance with IM regulations.

However, the report on the implementation of Regulation (EC) No 765/2008 published in

February 2013 as part of the PSMSP asserted that progress has already been made in the

development of a

risk assessment methodology.

It was noted that the existing RAPEX

Guidelines already provide for the risk assessment methodology for consumer goods, and are

an important reference point for Member States. Moreover, in 2011, the Commission set up a

Risk Assessment Task Force composed of Member States' experts whose role was to assess:

(i) whether the existing methodology, whose main focus is on non-harmonised products,

could suitably take into account the legal requirements of harmonised goods; (ii) how to

address the need to assess risks to public interests other than health and safety, which are not

taken on board by this methodology.

Through the research, we reviewed good practice in carrying out market surveillance (given

the broad focus of our study, only selected examples are possible). In the

Netherlands,

systems-based approach to market surveillance based on risk has been adopted. This was

recognised by interviewees in other countries such as

Latvia,

as being an interesting, and

potentially transferable example. An explanation as to how the system works is provided

below:

Table 6-1: A systems-based and horizontal approach to market surveillance and regulatory

enforcement

In the Netherlands, the government adopted the “Vernieuwd Toezicht” (Renewed Surveillanc

Programme) in 2008. The aim is to strengthen the efficiency and effectiveness of market surveillance

activities by fostering better relationships with economic operators and by raising awareness among

enterprises about their legal obligations under product safety and environmental legislation.

A distinction is made between (i) horizontal enforcement and (ii) system -based enforcement. These two

different types of enforcement are already being applied by some government inspections agencies.

Hor izonta l enfor cement

involves combining regulatory enforcement with horizontal activities and

support actions for enterprises.

Implementing a horizontal approach refers to the development of mutual cooperation between

Source: Systeemtoezicht en Horizontaal Toezicht, conceptleidraad voor de Rijksinspecties, Begrippen en randvoorwaarden,

December 2012 http://www.inspectieloket.nl/vernieuwing_toezicht/programma_systeemtoezicht/

440

government and society. Horizontal enforcement is based on building mutual trust and a working

relationship between government and economic operators based on the development and

implementation of quality management systems to strengthen regulatory compliance. The agreements

are set out in a covenant based on a partnership-based approach which is published on the inspection

agency’s website. The provision of relevant information, the exchange of knowledge, and if relevant the

monitoring of business activities are sufficient to consolidate compliance.

ystem enfor cement

focuses on the enforcement of quality and assurance systems and more specifically

on the development of a strategy for companies to set up robust regulatory compliance procedures,

documentation to measure the results achieved, interventions committed and the defects. Surveillance in

general takes place on the basis of periodical (administrative) inspections. Surveillance is not aimed at

checking whether individual regulations have been complied with. The confidentiality of the

government in the enterprise is still based on inspection.

The application of horizontal and system-based approaches means that that one agency may apply the

horizontal system and another may apply a system-based approach, while others adopt elements of both

approaches. Through the application of a horizontal and system-based approach, the inspection can

reduce the administrative burdens for enterprises/institutions which take their responsibility and do not

injure the confidentiality received from the government. In ad dition the surveillance institutions are in

the position to focus their capacity to enterprises performing not correctly.

An example of a surveillance authority that applies the system approach is the Food and Consumer

Product Safety Authority (Voedsel en Warenautoriteit). The systems-based approach is targeted at

larger manufactures and EU importers based on the following criteria: position in the value chain

(manufacturer, EU importer or major distributor); they must have a relatively large share of the market;,

regularly included on RAPEX or often having defects found during product inspections; their

willingness to invest in strengthening business-processes aimed at ensuring the safety of products.



Research Findings (RFs)

(RF64) There is a need for better definition and clarification of risk and how to assess it in the proposed

Market Surveillance Regulation, building on the proposed risk assessment methodology in the PMSP.

(Analysis of legal text; Interviews of MSAs)

(RF65) There is a need for guidance on the relative merits of the alternative approaches to market

surveillance and the circumstances under which each type of approach should be adopted. (Analysis of

legal text; Interviews of MSAs)

441

NNEX

7: R

EVIEW AND ASSESSMENT OF MARKET SURVEILLANCE ON NON

FOOD PRODUCTS

IN THE

NTRODUCTION

In the framework of the implementation of Regulation (EC) No 765/2008 (also 'the

Regulation') setting out the requirements for accreditation and market surveillance relating to

the marketing of products and repealing Regulation (EEC) No 339/93, Member States must

periodically review and assess the functioning of their market surveillance activities. Article

18(6) of the Regulation requires such reviews to be carried out at least every four years and

stipulates that the results are to be communicated to the other Member States and the

Commission and made available to the public.

As Regulation (EC) No 765/2008 has been applicable since 1 January 2010, the first round of

reviews and assessments communicated by the Member States relate to market surveillance

activities carried out between 1 January 2010 and 31 December 2013.

In order to facilitate their compilation and transmission of the information, the Commission

prepared

–

with the help of the members of the Internal Market for Products Expert Group,

IMP-MSG

–

a template that Member States could use to structure the relevant information.

Among other things, the template establishes a reference list of 29 sectors falling within the

scope of the Regulation that should be included in the Member States' reviews and assessment

(hereinafter 'the reference list of sectors').

Market surveillance carried out under Directive

2001/95/EC (General Product Safety Directive or GPSD) could be optionally included. At the

same time, the template left Member States free to determine the relevant criteria for the

assessment of the different (general/sectoral) market surveillance activities.

The reviews and assessments prepared by each Member states are available on the following

page (under the section "List of national reviews and assessments of the functioning of market

http://ec.europa.eu/growth/single-market/goods/building-

surveillance

activities"):

blocks/market-surveillance/organisation/index_en.htm.

The reports have also been published

by Member States

This annex gives a combined overview of the Member States' own reviews and the

assessments of market surveillance activities, and attempts to present main findings on the

implementation of the EU requirements for market surveillance.

In particular, the remainder of the document is structured as follows:

(a)

A snapshot of the information provided by each Member State by explaining the

approach taken when collecting and assessing the functioning of market surveillance

activities, the general organisation of market surveillance and the resources available to

it, the sectors covered by the national report and the conclusions drawn.

The main findings on the implementation of the Regulation at national level in the

2010-2013 period and points to challenges faced. Finally it contains some

considerations on the results of this first application of Article 18(6) of the Regulation.

(b)

The template also clarifies that market surveillance activities conducted under REACH and CLP Regulations fall within the scope of

Regulation 765/2008. However, since they are already the subject matter of specific reports available to the public, they could be

excluded from the reviews and assessment carried out pursuant to Article 18(6) of the Regulation.

However at the time of writing the Commission is still awaiting for confirmation of publication by one Member State.

442

(c)

A more detailed analysis of information provided by Member States for a specific sector

(Toys).

VERVIEW AND ASSESSMENT

All Member States, have communicated to the Commission their review and assessments of

market surveillance activities during the 2010-2013 period. The majority of Member States

chose to follow the common template prepared by the Commission, while Germany, Croatia,

Lithuania, the Netherlands and the UK chose a different format for their report.

Overall, most Member States provided a considerable amount of data and other information

on their activities. This section summarises the information provided by each Member State

by organising it according to the following scheme:

General market surveillance activities



General organisation: this part sums up the way market surveillance responsibilities are

distributed among different authorities and the main tools for cooperation and

coordination between them, as well as with customs in a given Member State. The

information contained in Member States' reports according to Article 18(6) of the

Regulation should be integrated with the information already provided in national

market surveillance programmes

and in the Report on the implementation of

Regulation (EC) No 765/2008

Resources: this part indicates the overall resources made available to market

surveillance, if mentioned in Member States' reports.

Own assessment: this part contains each Member State's own assessment of the

distribution of responsibilities, cooperation and coordination between national

authorities, as well as of the total resources available to them.

Market surveillance in specific sectors



Coverage: this part explains how many of the 29 sectors (plus 1 optional sector) that the

Commission recommended to include in the national reviews and assessments are

covered in each Member State's report.

Distribution of resources: this section indicates those sectors in which a given Member

State concentrates most of the available resources and those where resources are lacking

according to the national report.

Own assessment: this part summarises each Member State's own assessment of the

functioning of market surveillance sectoral activities in the 2010-2013.

Belgium

2.1

General market surveillance activities

General organisation: Belgium refers to the information on the general organisation of market

See the section "National market surveillance programmes " on the following page:

http://ec.europa.eu/growth/single-

market/goods/building-blocks/market-surveillance/organisation/index_en.htm

COM(2013)77.

443

surveillance provided in the national programmes. Market Surveillance pursuant to

Regulation (EC) No 765/2008 is handled at national level (with voluntary contributions from

individual regions) and is carried out by several federal government departments, agencies

and institutes. The majority of products covered by the harmonised European legislation fall

under the responsibility of the Federal Public Service (FPS) for Economy, SMEs, Self-

employed and Energy.

Table 7-1: Distribution Market Surveillance Responsibility in Belgium

FPS for Economy, SMEs, Self-

employed and Energy

Toys

Machinery

Cableway installations

Personal protective equipment

Lifts

Equipment for use in explosive atmospheres

Pressure equipment

Pressure receptacles

Household appliances measuring energy consumption

Central-heating boilers

Gas appliances

Low voltage electrical equipment

Electromagnetic compatibility

Non-automatic weighing instruments

Explosives for civil use

Pyrotechnic articles

Construction products

Pre-packaged products

FPS Health, Food Chain Safety Chemical products

and the Environment

Cosmetic products

Electrical and electronic equipment

Noise emissions of equipment used outdoors

Scientific

Health

Institute

for

Public In vitro diagnostic medical devices

FPS Finance

Customs activities

Federal Agency for Medicines and Pharmaceutical products

Health Products

Medical devices

Active implantable medical devices

444

FPS Mobility and Transport

Motorised vehicles

Transportable pressure equipment

Recreational craft

Railway systems

Marine equipment

Federal Agency for the safety of Fertilisers

the Food Chain

Belgian Institute for Postal Radio equipment and telecommunications terminal equipment

services and Telecommunications

Electromagnetic compatibility

Eco-design and energy labelling

Federal

Control

Agency

for

Nuclear Medical devices and similar products

Radiopharmaceuticals

Dosimeters

In cases where several authorities have responsibility for a particular area, the area is assigned

to the authority with primary responsibility.

There is no national body to coordinate market surveillance activities but for the purpose of

Article 18(5) (national programmes) and Article 22 (RAPEX) of the Regulation, a coordinator

role has been assigned to the Interministerial Economic Commission (IEC) within the Federal

Public Service for Economy for the exchange of information.

Overall resources: Belgium does not provide this resource information.

Own assessment: The report does not provide an assessment of the effectiveness or efficiency

of the general market surveillance organisation.

Market surveillance in specific sectors

Coverage: The Belgian report covers most sectors indicated in the reference list (including

non-harmonised consumer products falling under the GPSD) with the exception of medical

devices, cosmetics, transportable pressure equipment, cableways, pyrotechnics, explosives for

civil uses, recreational crafts and marine equipment.

Distribution of resources: Belgium provides information on resources for the period 2010-

2013 on market surveillance for some of the various federal government departments and

product sectors.

Resources for market surveillance for the FPS Economy decreased from 1.1 million EUR in

2010 to 0.8 million EUR in 2013, coupled with a decline in the number of inspectors from 11

to 7.5 full-time equivalent unit (FTEs) staff.

The FPS Public Health, Food Chain Safety and Environment is responsible for enforcing the

national Products Standards Act of 21 December 1998, checking a wide range of consumer

products for the possible presence of dangerous substances. A yearly budget of 425 000 EUR

(not including staff members) has been allocated for market surveillance, with 16 FTEs' staff

445

availability of which 13 inspectors.

The information on the amount of resources dedicated to market surveillance by the FPS

Mobility shows an increase in the period 2010-2013 from around 133 000 EUR to 206 000

EUR, with an increase in FTE availability from 1 to 2.5 (1.5 FTEs for inspectors).

The report stipulates allocation of resources on market surveillance on electrical appliances

and equipment falling under the low voltage directive (0.7-0.5 mln EUR; 0.6-0.4 staff),

appliances burning gaseous fuels (102 000-217 000 EUR; 1.0 staff) and eco-design and

energy labelling with a budget of 73 000 EUR over 2013 and 1 FTE for staff available.

Other indicated sectors are electrical equipment with a budget of 40 000 EUR over 2013 and

0.7 FTEs, electrical equipment falling under the Electromagnetic Compatibility Directive (48

000-40 000 EUR; 0.7 staff) and efficiency requirements for hot-water boilers (26 500 EUR-28

600 EUR; 0.2 staff). Coverage also extends to the construction products sector where 1.5

FTEs are allocated to market surveillance activities

Own assessment: The Belgian report provides information on enforcement and

communication activities carried out in most sectors. The results of some inspection

campaigns can be found on the responsible authorities' websites. In general the report does

not provide for an assessment of the effectiveness or efficiency of these sector-specific

activities.

2.2

Bulgaria

General market surveillance activities

General organisation: Market surveillance authorities within the meaning of Regulation (EC)

No 765/2008 are the following institutions:



the State Agency for Metrological and Technical Supervision (DAMTN), which carries

out market surveillance activities for products covered by the New Approach directives

(except Medical Devices), for eco-design requirements, for energy-related products, on

waste from electrical and electronic equipment and restriction of hazardous substances;

the Consumer Protection Commission (KZP), which is the specialized state authority in

Bulgaria dealing with the problems of consumer protection. It is also one of the main

internal market surveillance authorities. Its main activities relate to the surveillance of

the safety of general products and services on the Bulgarian market, the protection of

the main consumer rights, trade practices and methods of sale, etc. In addition KZP is

the Bulgarian contact point for the RAPEX system;

the Executive Agency for Medicines (IAL) to which are assigned the market

surveillance activities for medical devices;

the Regional Health Inspectorates (RZI) responsible for cosmetics and chemicals;

the Bulgarian Food Safety Agency (BABH), responsible for fertilisers;

the Technical Control Inspectorate (KTI) responsible for agricultural and forestry

machinery and



446



the Regional Inspectorates for the Environment and Water (RIOSV) responsible for

surveillance of

fluorinated greenhouse gases and ozone depleting substances

The market surveillance authorities function according to the distribution of competences

between four ministries, namely the Ministry of the Economy and Energy, the Ministry of

Health, the Ministry of Agriculture and Food and the Ministry of the Environment and Water.

Coordination and exchange of information between market surveillance authorities in

Bulgaria takes place by means of a Council established by a governmental act in 2005.

Overall resources: Bulgaria provides information on the resources of the two major market

surveillance authorities. From the total budget of DAMNT between 2010 and 2013, about 2.3

million EUR were dedicated each year to market surveillance related to the New Approach

directives

(except for Medical Devices), eco-design and waste of electrical and electronic

equipment

Furthermore, the authority employed each year 275 full-time equivalent unit

(FTE) staff (out of which about 150 inspectors). During the same period, the market

surveillance budget of KZP decreased from 1 to 0.7 million per year

and the authority

employed about 130 FTEs for staff (of which about 110 inspectors).

Own assessment: Bulgaria assesses the functioning of the main market surveillance

authorities (see section below). No specific assessment of general organisation (e.g.

cooperation and coordination) is provided.

Market surveillance in specific sectors

Coverage: The Bulgarian report covers all sectors in the reference list, except cosmetics,

efficiency requirements for hot-water boilers and marine equipment, as well as non-

harmonised consumer goods. It also includes, leather labelling, crystal glass, food-imitating

products, packaging, liquid fuels and wheeled tractors.

Distribution of resources: One third of DAMNT financial resources were dedicated to market

surveillance of products put into operation (industrial use) such as pressure equipment,

transportable pressure equipment, machinery, lifts, and cableways; about 25% was allocated

to market surveillance of products placed on the market like toys, personal protective

equipment, construction products, noise emissions, ATEX, pyrotechnics, civil explosives,

radio equipment and telecommunications terminal equipment, restriction of hazardous

substances and waste from electrical and electronic equipment, eco-design; about 13% to

market surveillance of measuring instruments.

More than two-thirds of the resources available for market surveillance to KZP were

dedicated to the enforcement of the Packaging Directive

(0.3-0.4 million EUR per year) and

the safety of non-harmonised consumer products (0.2-0.3 million EUR per EUR), followed by

leather, textile and energy labelling (respectively up to 80 000, 70 000 and 60 000 EUR/year

during the reporting period).

Own assessment: according to the Bulgarian report in the period 2010-2013 DAMTN

succeeded in achieving the general objectives laid down in the sectoral programmes by

applying the requirements of Regulation (EC) No 765/2008. On the other hand, difficulties

The budget also covers inspections of industrial equipment during use, as well as quality control of liquid fuels.

Correspondingly, the share of KZP's resources dedicated to market surveillance went down from 62% to 40%.

Directive 94/62/EC.

447

experienced in market surveillance relate in particular to the lack of information in tracing

products back along the distribution chain to the producer or the responsible economic

operator, lack of cooperation by certain economic operators, e-commerce challenges, high

cost of tests in some sectors, unavailability of expert staff to carry out assessment of

compliance in certain sectors (e.g. personal protective equipment).

KZP is also considered to have achieved good results, despite an insufficient number of staff

having to deal with an increasing volume of activities. The same inspectors carry out market

surveillance activities in all sectors falling within the competence of the KZP. A lack of

material and financial resources hampers work relating to the outsourcing of laboratory

analyses establishing product compliance with safety requirements or the conformity and

reliability of information provided by economic operators in labels or advertising messages.

The Bulgarian report contains information on the way the other authorities work in their

respective areas. A specific assessment of their activities is not systematically provided.

2.3

Czech Republic

General market surveillance activities

General organisation: market surveillance in the Czech Republic is carried out by various

central government bodies

–

authorities subordinated to specific ministries with specific

powers. Coordination among authorities and with customs is ensured by bilateral agreements.

The report from the Czech Republic does not provide an overview of the general organisation

of market surveillance at national level. On the other hand, it refers to the detailed annual

reports prepared by some of these authorities, notably by the Trade Inspectorate Authority

(CTIA), which assumes overall responsibility for the vast majority of the product areas

mentioned in the reference list of sectors (medical devices, toys, protective equipment,

aerosol, machinery, lifts, noise emissions, equipment for use in potentially explosive

atmospheres, gas appliances, electromagnetic compatibility, low voltage electrical products

and appliances, radio equipment and telecommunications terminal equipment, measuring

instruments, recreational crafts, as well as timber, batteries and novelty lighters.

Overall resources: the total national resources for market surveillance cannot be estimated

because the budget of the relevant authorities does not distinguish between funds earmarked

for market surveillance and other tasks. The same can be said for staff. However as CTIA

carries out almost exclusively market surveillance its total budget

(on average around 9.5

million EUR per year between 2010 and 2013) provides a good indication of resources for

market surveillance for most sectors.

The total number full-time equivalent units (FTE) for staff employed in market surveillance

was between 940 and 1090 per year

, out of which between 415 and 445 inspectors.

Resources decreased over the 2010-2013 period.

Own assessment: According to the national report the functioning of market surveillance in

The figure excludes the wages of personnel not directly involved in markets surveillance.

Between 415 and 460 staff was employed by CTIA, 414-479 for the Environmental Inspectorate (chemicals and consumer products

under the GPSD), 50-60 people worked for the Energy Inspectorate (competent for the area of ecodesign and energy labelling), 47

for the Health Ministry (cosmetics, products for children up to three years and food contact materials), 35 for the Rail Authority

(interoperability, simple pressure vessels, transportable pressure equipment and cableways),5 for the Arms and Ammunition

Authority (pyrotechnics, firearms and ammunitions) and 0.5 or the Mining Authority (civil explosives and mining machinery.

448

the Czech Republic can generally be considered effective. The level of cooperation between

surveillance authorities is very good. In areas where the powers of certain supervisory

authorities overlap, rules are in place to ensure effective coordination of the surveillance.

Individual surveillance authorities carry out specifically-focused inspections, the results of

which are then used both to set priorities for further surveillance activities and to enhance the

efficiency of surveillance authorities’ activities.

Various surveillance authorities keep their

own databases of monitored products, and this undoubtedly has a positive impact on the

overall success of surveillance activities.

The representatives of the various market surveillance authorities regularly attend European

and international meetings; relevant market surveillance information is then shared with other

surveillance authorities.

The main problems encountered by surveillance authorities relate to:

The persistent problem lack of funds and material resources to ensure the truly effective

implementation of surveillance activities.

The lack of an accident and injury database (IDB) to determine surveillance priorities.

Frequent difficulties in tracking and tracing products/manufacturers throughout the

supply chain (particularly from third countries), which is naturally reflected in the

overall efficiency and effectiveness of market surveillance. The sale of products via e-

shops further contributes to this.

The proportion of poor-quality, high-risk products from third countries that reach the

market via informal supply channels (e.g. marketplaces), where the efficiency of

surveillance remains questionable.

Market surveillance in specific sectors

Coverage:

the Czech report includes all sectors in the reference list, plus timber products,

mining machinery, batteries, blasting technology resources and food contact materials.

Distribution of resources: There is no information on the distribution of financial resources.

As to the staff figures reported in the section above on overall resources, it is noted that about

75% of total inspectors were employed by CTIA, slightly less than 10% by the Energy

Inspectorate competent for eco-design and energy labelling and a further 5% by the

Environmental Inspectorate competent for chemicals.

Own assessment: the Czech Republic provides extensive information on enforcement and

communication activities carried out in most sectors and points to challenges faced;

furthermore, additional information can be found in some of the annual reports produced by

Czech authorities

. On the other hand, the report does not provide for a more general

assessment of the effectiveness or efficiency of these sector specific activities.

For instance the latest CTIA annual report indicates that in 2013, the Czech Trade Inspection Authority carried out a total of 37,299

inspections, which was 23% less than in the previous years. However, the rate of inspections with findings increased from 28.6% in

2012 to 35.5% in 2013.

449

2.4

Denmark

General market surveillance activities

General organisation: Denmark refers to the information on the general organisation of

markets surveillance provided in the national programmes. Due to the decentralised

organisation of market surveillance in Denmark, the Market Surveillance Committee

established in 2010 has the task of contributing to the exchange of information about

initiatives and strategic projects, to disseminate best practices (e.g. to ensure that the

authorities make the best possible use of the tools available for exchanging information) and

to help to clarify the boundaries between authorities and create opportunities for collaboration

in overlapping areas. The Committee is chaired by the Danish Business Authority. The latter

authority and the Danish Safety Technology Authority serve jointly as the Secretariat.

Compliance with the Regulation's requirement largely depends on the active commitment of

the authorities to the work of the Market Surveillance Committee.

Overall resources: Between 2010 and 2013, Denmark devoted between 8.2 and 8.6 million

EUR per year to market surveillance. Overall staff available to market surveillance can be

estimated at around 72-78 full-time equivalent units (FTE) (among which between 30 and 35

inspectors

). Data show that the budget and staff for the market surveillance authorities

remained fairly constant over the 2010-2013 period. The figures are largely based on

estimates and therefore have some uncertainty associated with them.

Own assessment: According to the Danish report, market surveillance in Denmark is working

well overall, and collaboration between the relevant authorities is satisfactory. Danish

authorities also participate actively in relevant European fora, including the ADCO groups

(administrative collaboration). None of the authorities have reported any problems in relation

to collaboration with the notified bodies.

The following challenges are identified:

The need to always prioritise initiatives and optimise the use of resources in order to

implement comprehensive, effective market surveillance.

The ineffectiveness of surveillance and penalties in respect of e-commerce businesses

that sell to Danish consumers, but are situated in third countries or merely act as

intermediaries.

Businesses' lack of knowledge and guidance concerning the legislation.

Examples of cases where authorities in the Member States take contradictory decisions

despite harmonised legislation.

Market surveillance in specific sectors

Coverage: The Danish report covers almost all sectors indicated in the reference list

(including non-harmonised consumer products), the only exception being explosives for civil

uses and efficiency requirements for hot-water boilers. It also includes food contact materials

The proportion of staff who are inspectors may be slightly greater, since some authorities have not classified their staff in more

detail.

450

and some national legislation.

Distribution of resources: The sectors to which the greatest part of resources was allocated are

medical devices (1.5-2 mln EUR; 9-11 staff), machinery (1.3-1 mln EUR; 11.3-8.8 staff),

electrical appliances and equipment falling under the low voltage directive (1-1.2 mln EUR;

10.7-12.3 staff).

The report notes that no ad hoc resources were allocated to market surveillance in the areas of

noise emissions and recreational craft.

Own assessment: Demark provides extensive information on enforcement and communication

activities carried out in most sectors and points to challenges faced. In general the Danish

report does not provide an assessment of the effectiveness or efficiency of these sector

specific activities.

2.5

Germany

General market surveillance activities

General organisation: Information on the general organisation of market surveillance in

Germany can be found in the national programme for 2014. In Germany the responsibility for

market surveillance falls within the remit of the Länder. Since 2000, the coordination of

activities of the individual Länder is ensured by the Working Committee on Market

Surveillance (AAMÜ). AAMÜ also decides on inter-regional focus initiatives in Germany as

part of proactive market surveillance. This Committee also includes representatives from

customs authorities and other sectors, e.g. the Federal Network Agency (electromagnetic

compatibility and R&TTE directives) and the German Institute for Construction Technology

(construction products).

From 1 January 2013 the coordination tasks of the Länder market surveillance authorities, as

in Article 18(5) (national programmes), Article 22 (RAPEX) and Article 23 (ICSMS) of

Regulation (EC) No 765/2008, were transferred to the Central Authority of the Länder for

Safety (ZLS). In certain cases ZLS also has the power of enforcement in relation to a specific

product. The new set up has improved coordination.

Overall resources: Germany has omitted information on financial resources and staff as it

believes that it would not contribute towards any conclusion on the effectiveness or efficiency

of market surveillance activities.

Own assessment: The national report does not provide an assessment of the general

organisation of market surveillance in Germany.

Market surveillance in specific sectors

Germany's report under Article 18(6) of the Regulation follows a different approach from that

proposed in the common template. Germany summarises the results of the market surveillance

actions included in the four-year programme established in 2010. Exceptions are made for the

Electrical products under electromagnetic compatibility and the radio equipment and

telecommunications terminal equipment sectors for which more specific information has been

provided (see below).

Coverage: In general, the German report concerns the sectors covered by the national Product

451

Safety Act which transposed the General Product Safety Directive and 12

other directives

among the 29 included in the reference list of products. In addition the Product Safety Act

covers non-harmonised non-consumer products.

The report focuses on the 11 target areas for proactive market surveillance mentioned in the

programme for sectors covered by the Product Safety Act. Some of these areas are based on

hazard presented by products, while others are of a more horizontal nature. The majority of

these action areas cannot be linked directly to specific product sectors. The table below shows

the number of market surveillance campaigns

implemented under each area.

Table 7-2: Action areas and corresponding market surveillance campaigns

Action area

Area 1: Optimisation of target group-specific information

Area 2: Uniform application of revised RAPEX guidelines

Area 3: Cooperation with customs authorities

Area 4: Electronic sales channels

Area 5: Safety through standardisation

Area 6: Hot surfaces

Area 7: Electrical fire hazards

Area 8: Closing forces

Area 9: Market surveillance and operational safety

Area 10: Safety of products for children

Area 11: Cheap products from non-EU countries

Number of market surveillance campaigns

166

247

127

408

158

631

Furthermore, Germany reports the following information on specific sampling and testing

activities conducted under the Product Safety Act:

Overall the market surveillance authorities of the Länder performed approx. 78 000 checks in

total from 2010 to 2013, in which around 138 000 products were inspected with regard to

their conformity;. 4 761 products were tested in laboratories.

It was found that 47 % (65299) of the products inspected did not comply with

requirements22. By contrast, the proportion of those products that presents a serious risk is

only 0.7 % (1032 cases).

Aerosol dispensers (75/324/EEC), Simple pressure vessels (2009/105/EC), Personal protective equipment (89/686/EEC),

Appliances burning gaseous fuels (2009/142/EC), Equipment and protective systems intended for use in potentially explosive

atmospheres (94/9/EC), Recreational craft (94/25/EC), Lifts (95/16/EC), Pressure equipment (97/23/EC), Machinery (2006/42/EC),

Low voltage (2006/95/EC) , Toys (2009/48/EC), Noise emission in the environment by equipment for use outdoors (2000/14/EC).

This may either consists in sampling and testing, or also encompass activities such as collecting, processing and editing of

information (e.g. on categories of potential users).

The percentage of rejected products does not indicate a representative value for the entire market; it is due to the fact that official

investigations are initiated primarily in those cases where it can be assumed there is a high probability that non-compliant products

are being placed on the market

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About 15% (2930) of the overall measures (17969) were taken by market surveillance

authorities, while the rest was taken voluntarily by companies.

Following those measures, 562 products were withdrawn from the market, 100 products were

recalled from consumers, 8863 products were destroyed and 206 sanctions were imposed.

Distribution of resources: The report mentions resource allocation to Electrical products under

electromagnetic compatibility and the radio equipment and telecommunications terminal

equipment

sectors. In total and between 2010 and 2013 € 12.1 million to € 11.6 million were

available to the market surveillance authorities with a staff allocation of a consistent 85 full-

time equivalent units (FTE).

Own assessment: Germany considers that setting priorities in the form of action areas proved

useful in a context of limited resources, although experience suggests that certain action areas

should be adjusted or discontinued and new action areas added (e.g. market surveillance at

trade fairs, involvement in standardisation). No assessment of the effectiveness or efficiency

of market surveillance activities in specific sectors is provided. Improvements in market

surveillance are needed to address the challenge of on-line sales where the relevant economic

operator is often outside the EU and border controls are performed by customs, for which

product specific-specialist knowledge must be available.

2.6

Estonia

General market surveillance activities

General organisation: Market surveillance is carried out by seven authorities: the Consumer

Protection Board, the Health Board, the Technical Surveillance Authority, the Labour

Inspectorate, the Maritime Administration, the Environmental Inspectorate and the

Agricultural Board.

To facilitate cooperation and exchange of information between the authorities, a market

surveillance council has been set up at the Ministry of Economic Affairs and

Communications, made up of representatives from all market surveillance authorities,

including the Tax and Customs Board, and from the ministries under whose jurisdiction they

operate. Exchange of information between market surveillance authorities also takes place

bilaterally.

Overall resources: Estonia states that it is not possible to indicate financial resources that are

dedicated solely to market surveillance, since this is only a part of the responsible authorities'

activities. It is possible to indicate the operating expenses of the authorities as a share of the

total national budget. This translates into 29.7 million EUR in 2010 (0.53% of 5.6 billion

EUR) and increasing to 35.4 million EUR in 2013 (0.46% of 7.7 billion EUR).

Further, the number of staff available to market surveillance authorities ranged from 1354

full-time equivalent units (FTE) in 2010 to 1360 FTEs in 2013, of which 43 to 41 were

dedicated to inspectors.

Own assessment: The report indicates that the results of Estonia's market surveillance

activities are good and the functioning of the country's organisation and infrastructure is

qualified as efficient. The taking part in international cooperation projects by some market

surveillance authorities has provided a good overview of practices in other countries. In the

same way the exchanges of officials programme financed by the European Commission has

453

also been assessed as useful.

The main challenges for market surveillance authorities derive from:

The plurality of sectors and responsibilities coupled with limited human resources,

training and in-service training opportunities. The lack of resources pushes Estonia

towards a more risk- and project-based surveillance, but awareness of regulations

among economic operators is described as poor, meaning that there is additional

pressure on resources for starting awareness-raising campaigns.

Increase of e-commerce and catalogue sales that make it difficult for the authorities to

perform checks.

Non-existence of test laboratories and notified bodies making the assessment of

conformity in major technical sectors very difficult.

Carrying out market surveillance and the harmonisation of customs procedures.

Problems have been noted in cases where an economic operator wants to import a

product with no CE marking and bring it into conformity with the requirements at a

later stage. In these types of situations Estonia mentions that surveillance authorities

have difficulties reconciling the concepts of "placing on the market" and "release for

free circulation" as defined in Regulation (EC) No 765/2008. It has not always been

possible to carry out these operations in the customs zone.

Perceived shortcomings in national legislation. Estonia's market surveillance authorities

report that the wording of legal acts is often perceived as ambiguous for economic

operators. Further, cooperation between authorities has on occasion been suspended

since it was not clear how they should divide the responsibility for surveillance on

certain products. Estonia found a solution to this through mutual agreements and

amendments to legal acts.

Market surveillance in specific sectors

Coverage: The Estonian report covers most sectors indicated in the reference list (including

non-harmonised consumer products falling under the GPSD such as lighters and children's

clothing) with the exception of eco-design and energy labelling, efficiency requirements for

hot-water boilers fired with liquid or gaseous fuels and non-road mobile machinery.

Distribution of resources: No information on the distribution of resources is provided.

Own assessment: Estonia provides extensive information on enforcement and communication

activities carried out in most sectors, and points to the challenges faced. The report does not

provide an assessment of the effectiveness or efficiency of these sector-specific activities.

2.7

Ireland

General market surveillance activities

General organisation: Market surveillance is dispersed across various Government

Departments and State Agencies and responsibility for Community harmonisation legislation

454

is allocated according to competence. The responsibilities of market surveillance authorities

are conferred through primary legislation in the case of chemicals and secondary legislation

implementing Community harmonisation legislation for the other sectors.

There is no national body to coordinate market surveillance activities nor does a single piece

of overarching market surveillance legislation exist. Under Regulation (EC) No 765/2008 the

Department of Jobs, Enterprise and Innovation coordinates Ireland's notifications.

Overall resources: Ireland does not provide specific resource information and states that there

is no specific budget to fund market surveillance authorities since they are part of larger

organisations. It is estimated that approximately 4.8 million EUR is available to authorities

for market surveillance activities. The number of staff available to market surveillance

authorities remained somewhat stable from 41.7 full-time equivalent units (FTE) in 2010 to

41.6 FTEs in 2013 in total.

Own assessment: The Irish report identifies the following issues in the functioning of market

surveillance:

The resources of the HSA have been reduced in recent years which impact negatively

the ability to engage in market surveillance. Further the absence of independent test

laboratories renders assessing of conformity very difficult and costly. Problems also

arise on the reporting and recording of accidents that occur outside the workplace since

there is no state supported system in place.

The NCA has been operating with 7 to 8 FTEs in the Product Safety Unit. The report

mentions significant budgetary and staffing constraints.

Market surveillance in specific sectors

Coverage: Ireland reports on most of the sectors from the reference list (including non-

harmonised consumer products falling under the GPSD) with the exception of construction

products, aerosol dispensers, cableways, noise emissions for outdoor equipment, radio and

telecom equipment under electromagnetic compatibility and radio equipment and

telecommunications terminal equipment, efficiency requirements for hot-water boilers,

recreational crafts, marine equipment and non-road mobile machinery.

Distribution of resources: Information on the distribution of resources is provided for the

medical devices sector with a stable budget of 1.4 million EUR for 2010-2013 and a full-time

equivalent unit (FTE) availability of 15.8 to 17.3, with 1.5 FTEs for inspectors. Eco-design

and labelling had a budget of 150 000 EUR allocated with 1 FTE available in 2013 and 4

FTEs for inspectors.

The electrical and electronic equipment sector under restriction of hazardous substances,

waste from electrical and electronic equipment and batteries directives had a budget allocated

of approximately 37 000 EUR with a spike of 64 500 EUR in 2012 (between 0.25 and 0.20

FTEs staff available). The chemicals sector had a budget available from around 44 300 EUR

in 2010 to 25 500 EUR in 2013, with 0.14 to 0.05 FTE staff availability in the same period.

No financial budget is indicated for the cosmetics sector but between 6.25 and 7.25 FTEs was

available for market surveillance activities between 2010 and 2013 (5.25 FTEs for

inspectors). For fertilisers these were 2 FTEs available for market surveillance activities

between 2010 and 2013 (1.5 FTEs for inspectors).

455

Own assessment: In the area of medical devices, the HPRA does not have any legislative

powers over distribution or distributors apart from the provisions set out in the New Approach

legislation. Concern is particularly on the device management, storage and traceability

throughout the distribution chain. Legislative powers are being sought to request distributors

to conduct appropriate follow-up and be required to request an audit of their quality systems.

Further, on the specific

sector of medical devices and cosmetics, Ireland’s report on its market

surveillance activities notes that enforcing compliance on medical devices and cosmetics sold

through online web shops is challenging due to issues around traceability. Concerning

medical devices the HPRA is actively involved in developing the framework for

implementing a unique device identifiers (UDI) system. Applying a harmonised market

surveillance approach and action effectively is seen as problematic when different Member

States take varying positions in the qualification and classification of products as medical

devices.

Issuing alerts on hazards is required under the EU legislation, but not specifically addressed

under national legislation which is seen as problematic. Furthermore, in the event a serious

issue arises and action is taken under the medical device legislation, the penalties are deemed

as minor when the potentially serious nature of the offence is considered.

2.8

Greece

General market surveillance activities

General organisation: Market surveillance pursuant to Regulation (EC) No 765/2008 is

handled at national level. Greece reports that in 2012 a new legal framework was developed,

with the General Secretariat for Industry of the Ministry of Development and Competitiveness

as the country's National Market Surveillance Authority. The body is responsible for

coordinating the other market surveillance authorities already in place, and for streamlining

communication. The report mentions that an audit methodology has been developed for each

product, at manufacturers' premises and at product operating, distribution and storage sites.

An electronic national information exchange system has been put in place that should back

the market surveillance procedure.

Overall resources: Greece does not provide general resource information per market

surveillance authority since they have not been identified separately. An amount of 50 000

EUR (excluding wage costs) is estimated for the General Secretariat for Industry.

Own assessment: The report does not provide an assessment of the effectiveness or efficiency

of the general market surveillance organisation. It identifies the lack of financial resources as

a challenge, particularly with regard to the costs of laboratory tests and the transportation of

inspectors. Other challenges mentioned are:

The lack of traceability of information during laboratory tests in some sectors.

The lack of having specialised inspectors in place for certain sectors (e.g. lifts).

The lack of consistency in imposing sanctions.

The difficulty of locating the responsible person in the supply chain.

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The overlap of responsibilities in certain sectors (e.g. noise emissions).

Market surveillance in specific sectors

Coverage: The Greek report covers most sectors indicated in the reference list (including non-

harmonised consumer products falling under the GPSD) with the exception of medical

devices, cosmetics, noise emissions for outdoor equipment, equipment and protective systems

intended for use in potentially explosive atmospheres, marine equipment, motor vehicles and

tyres and non-road mobile machinery.

Distribution of resources: No information on the distribution of financial resources per sector

has been provided, with the exception of the radio equipment and telecommunications

terminal equipment sector with a budget of around 33 000 EUR allocated in 2010 and 8 500

EUR in 2013. 5 full-time equivalent units (FTE) have been attributed in this period (from 2 to

4 FTEs for inspectors). In general 0.2 to 2.5 FTEs of staff are allocated to most sectors with

chemicals being the exception counting 90 FTEs of staff of which 65 FTEs of inspectors

available to market surveillance authorities.

Own assessment: Greece provides extensive information on enforcement and communication

activities carried out in most sectors and points to challenges faced that reflect those

mentioned previously. In general the report does not provide an assessment of the

effectiveness or efficiency of these sector-specific activities.

2.9

Spain

General market surveillance activities

General organisation: Market surveillance is coordinated at national level by the Spanish

Consumer Affairs, Food Safety and Nutrition Agency (which acts on rare occasions as a

surveillance authority) and is carried out by various authorities who are organised on either a

national or regional level. Only in very special cases involving imports or products controlled

by the customs authorities does it act as a market surveillance authority.

The customs authorities are part of the Tax Agency but border controls also involve another

body called SOIVRE (the Official Service of Surveillance, Certification and Technical

Assistance of Foreign Trade). It monitors a series of products before they reach the customs

offices. It conducts surveillance activities with regard to documents, inspections and testing.

For the sectors of products, toys, textiles, shoes, some personal protective equipment, some

electrical products and wood products and their derivatives, a safety certificate must be

obtained in advance from SOIVRE so that customs can release them for free circulation. The

Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) acts as a

market surveillance authority only in cases where the customs authorities ask for support on

the basis of Articles 27-29 of Regulation (EC) No 765/2008 (The report mentions it carries

out 80 exercises each year). It is also the contact point for RAPEX.

Furthermore, the Ministry of Industry, Energy and Tourism examines the extent of legislative

compliance of the industrial products placed on the markets (1349 industrial products were

inspected in 2013). The main lines of action that are described in the report focus on the

inspection of distribution centres (through reactive and proactive compliance assessment) and

the testing on products in accordance with the legislation in force.

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Overall resources: No general resource information per market surveillance authority is

specified but the combined estimated budget of the consumer affairs authorities is mentioned.

Approximately 26.7 million EUR was available to authorities in 2010 to 20.7 million EUR in

2013, which is approx. 0.025% of the national budget. The number of staff available to

market surveillance authorities counted 312 full-time equivalent units (FTE) in 2010 and

dropped to 208 FTEs in 2013 in total. Between 212 and 125 FTEs were available for

inspectors.

Own assessment: The report does not provide an assessment of the effectiveness or efficiency

of the general market surveillance organisation but points to challenges faced. In particular,

the shortage of resources is a main cause of lack of monitoring of imports and problems with

traceability of products. It also mentions that penalties laid down in national law might not be

a sufficient deterrent for larger companies trying to market non-compliant products. The

country aims to increase the use of ICSMS.

Market surveillance in specific sectors

Coverage: The Spanish report provides some information on enforcement activities (i.e.

number inspections, tests performed, finding of non-compliance and restrictive measures

taken) on the sectors that fall under the responsibility of the Subdirectorate-General for

Quality and Industrial Safety of the Ministry of Industry, Energy and Tourism only i.e. list,

electrical appliances and equipment under the low voltage directive, radio and telecoms

equipment under electromagnetic compatibility directive, machinery, pressure equipment,

construction products, chemicals and lifts.

Distribution of resources: No information on the distribution of financial resources per sector

has been reported.

Own assessment: In general the report does not provide an assessment of the effectiveness or

efficiency of these sector-specific activities.

2.10 France

General market surveillance activities

General organisation: France refers to the information on the general organisation of markets

surveillance provided in the national programmes. In France, market surveillance is mainly

performed by officials of the Directorate-General for Competition, Consumer Affairs and

Fraud Repression (DGCCRF) and, for products imported from countries outside the European

Union, the Directorate-General for Customs and Indirect Taxation (DGDDI) which is a

surveillance authority for the entire market so that customs officials may collect samples of

products, have them tested by a laboratory and, depending on the test results, decide on any

action to be taken. The DGCCRF and DGDDI have a territorial network at their disposal. For

laboratory tests they can use the Joint Laboratory Service (SCL) and can also call upon

private laboratories.

Other services also contribute to market surveillance

, either by carrying out checks

They include the: Direction Générale de la Compétitivité, de L'industrie et des Services (DGCIS), for measuring instruments;

Direction Générale de la Prévention des Risques (DGPR) for gas appliances, pressure equipment, chemical products, explosives and

materials for use in potentially explosive atmospheres; Direction des Affaires Maritimes (DAM) for recreational craft and marine

equipment; Direction Générale du Travail (DGT) for machinery and equipment, and personal protective equipment; Service

Technique des Remontées Mécaniques et des Transports Guidés (STRMTG) for cableway installations used to transport persons;

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themselves or with the help of services on the ground.

The Ministry of Economy, Directorate-General for Competitiveness, Industry and Services

(DGCIS) DGCIS, ensures coordination of the application of Regulation (EC) No 765/2008

Overall resources: In the 2010-2013 period between 2.5 and 2.9 million EUR per year were

dedicated to testing of toys, cosmetics and professional products, while around a further 1.5

million EUR per year were dedicated to testing of equipment for use in potentially explosive

atmospheres, pyrotechnical articles, radio equipment and telecommunications terminal

equipment and, to a lesser extent, to pressure equipment, gas appliances and civil explosives.

In addition to these figures, the report mentions about 13.5 million EUR (excluding testing

activities) allocated to market surveillance authorities in a number of (mainly consumer

product) sectors.

In various sectors resources declined over the 2010-2013 period. No

specific details on resources for market surveillance are given for medical devices,

professional machinery, lifts, cableways, noise emissions and products falling under

restriction of hazardous substances, waste from electrical and electronic equipment and

batteries legislation. Overall over 260 full-time equivalent units (FTE) are reported for all the

sectors mentioned above for both testing and other activities. These figures do not include

customs budget and staff for market surveillance.

Own assessment: The French report does not contain an assessment of the general

organisation of market surveillance.

Market surveillance in specific sectors

Coverage: The French report covers all sectors in the reference list (including non-harmonised

consumer products), except eco-design, efficiency requirements for boilers and non-road

mobile machinery.

Distribution of resources: By looking at the overall resources mentioned in the above sections,

between 2010 and 2013 the biggest share of resources (about 25%) was allocated to non-

harmonised consumer goods, about 10% each respectively to toys, cosmetics and radio

equipment and telecommunications terminal equipment, 5% respectively to low voltage

electrical products and energy labelling

Own assessment: According to the French report overall market surveillance activities

functioned satisfactorily in France, and products covered by harmonised European regulations

were subject to appropriate inspection. Apart from a few exceptions, such as cosmetics

products, a more specific assessment of the activities carried out in a given sector is not

provided.

In some sectors (i.e. equipment for use in potentially explosive atmospheres, pyrotechnical

articles, civil explosives and gas appliances), insufficient cross-border cooperation is

mentioned as a difficulty to tackle when relevant economic operators are located abroad. In

others (radio equipment and telecommunications terminal equipment) it is noted that control

procedures are not adequate to handle products sold on line.

Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) for medical devices and cosmetics; Agence

Nationale des Fréquences (ANFR) for radio equipment.

Budget including both tests carried out by State laboratory and tests subcontracted to private laboratories.

Toys, cosmetics, consumer machinery, non harmonised consumer goods, construction products, electromagnetic compatibility,

radio and telecommunications, low voltage electrical products, chemicals, energy labelling, recreational craft, motor vehicles,

fertilisers.

The percentage mentioned here are very rough and purely indicative estimates.

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2.11 Croatia

General market surveillance activities

General organisation: The report covers the period 1 July 2013 to 31 December 2013 and

mentions that the overall responsibility for market surveillance was with the State

Inspectorate until the end of that year. Upon becoming a Member State of the European

Union a contact point was set up in the Inspectorate for the exchange of official notifications

on measures and actions (through RAPEX). The Inspectorate conducted inspections with the

Customs Administration of the Ministry of Finance implementing Articles 27 to 29 of

Regulation (EC) No 765/2008. A Commission that was set up in 2009, and that had ceased its

activities by the end of 2013, coordinated and communicated between inspectorates

responsible for controls of products placed on and/or made available to the market.

As of 1 January 2014 the Ministry of the Economy took over the tasks of the State

Inspectorate, namely the protection of consumers, product safety and pressure equipment and

the tasks of the mining and electricity inspectorate.

Other authorities are the State Office for Metrology (measuring instruments, non-automatic

weighing instruments and pre-packaged products), the Ministry of the Interior (pyrotechnical

articles), the Croatian Regulatory Authority for Network Industries (radio equipment and

telecommunications terminal equipment), the Ministry of Agriculture (fertilisers) and the

Ministry of Health (cosmetic products, toys and chemical products)

Overall resources: No further general resource information is specified.

Own assessment: The report does not provide an assessment of the effectiveness or efficiency

of the overall market surveillance organisation.

Market surveillance in specific sectors

Coverage: For the period indicated above, the Croatian report covers: (i) the sectors under the

responsibility of the State Inspectorate, i.e. personal protective equipment, construction

products, machinery, electrical appliances and equipment under the low voltage directive,

other consumer products under GPSD (lighters and children's clothing with drawstrings) and

textile products and footwear in accordance with Regulation (EC) No 1007/2011 and

Directive No 94/11/EC; (ii) other sectors covered by the State Office for Metrology

(measuring instruments, non-automatic weighing instruments and pre-packaged products), the

Ministry of the Interior (pyrotechnical articles), the Croatian Regulatory Authority for

Network Industries (radio equipment and telecommunications terminal equipment), the

Ministry of Agriculture (fertilisers) and the Ministry of Health (cosmetic products, toys and

chemical products);

Distribution of resources: No information on the distribution of financial resources per sector

has been reported.

Own assessment: In general the report does not provide an assessment of the effectiveness or

efficiency of these sector-specific activities.

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2.12 Italy

General market surveillance activities

General organisation: Italy refers to the information on the general organisation of markets

surveillance provided in the national programmes for the 2010-2013 periods. It also recalls

that a least 7 Ministries are responsible for market surveillance activities under the scope of

the report, in addition to Guardia di Finanza, which carries out product safety controls in the

national territory, and the Customs Agency, responsible for product checks at the border.

Overall resources: In the section on overall resources, Italy mentions about 1.5 mln EUR per

year; however this budget actually coincides almost entirely with the budget of the Ministry

of Economic Development which is responsible for many - but not all, and not exclusively

of the product areas falling under the scope of the Regulation (i.e. personal protective

equipment, electromagnetic compatibility, low voltage electrical products and appliances,

radio equipment and telecommunications terminal equipment, measuring instruments, eco-

design and energy labelling legislation, labelling of textiles and footwear), as well as for

general product safety.

The section also mentions about 1 100 full-time equivalent units for staff (FTE) (of which 100

customs staff, about 100 staff units of various ministries

that carry out documentary checks,

and more than 900 inspectors

that carry out field work) for market surveillance in the areas

of responsibility of the Ministry of Economic Development (see above), the Ministry of

Health (toys, consumer goods, medical devices and cosmetics), the Employment Ministry

(machinery) and the Environment Ministry (noise emissions).

Own assessment: According to the national report, the entry into force of the Regulation

helped the development of market surveillance in Italy. The practice of national programmes

has helped to focus controls on products intended for vulnerable consumers (children and

elderly), and has brought about several restrictive measures of both a voluntary and

mandatory nature. Italy's report considers that market surveillance conducted between 2010

and 2013 has been effective overall, in particular due to the importance given to the training

of inspectors. The lack of resources however limits the ability to ensure continuity in training,

as well as to increase the number of (proactive) inspections and laboratory checks.

Market surveillance in specific sectors

Coverage: Italy's report covers 15 of the 29 sectors indicated in the reference list. Excluded

from the report are, in particular, construction products, pressure equipment, lifts, gas

appliances, electrical equipment falling under the electromagnetic compatibility directive,

certain chemicals, motor vehicles, recreational craft, equipment for use in potentially

explosive atmospheres and non-road mobile machinery. On the other hand, Italy's report

includes non-harmonised consumer products, tobacco products and the labelling of footwear.

Distribution of resources: Italy's report does not contain information on the overall amount of

E.g. the Health Ministry, the Carabinieri's specialised territorial cells called NAS and the regional offices share responsibility for

conducting inspections in the area of some consumer products, including toys. Furthermore, Guardia di Finanza verifies the

execution of restrictive measures issued by the Ministry of Economic Development. The resources of these other entities involved in

market surveillance are not included.

63 people from the Ministry of Economic Development, around 25-30 from the Ministry of Health dealing with certain aspects of

toys, consumer goods; medical devices and cosmetics and a few units from the Employment and Environment Ministries dealing

respectively with machinery and noise emission legislation.

This figure includes 500 FTEs from Guardia di Finanza, 275 from Chambers of Commerce, 100 Carabinieri NAS.

461

resources dedicated to market surveillance and its distribution across sectors. The figure of 1.5

million EUR is provided for market surveillance carried out by the Ministry of Economic

Development notably in relation to a range of consumer goods and to eco-design/energy

labelling legislation.

The report notes that no ad hoc financial resources are attributed to market surveillance in the

areas of maritime equipment, pyrotechnics and civil explosives, where only some limited

reactive surveillance activity is carried out

The figures on staff are covered in the previous section on overall resources.

Own assessment: Italy provides quite extensive information on enforcement and

communication activities carried out in several sectors, and points to challenges faced

(notably the lack of resources); however in general the Italian report does not provide an

assessment of the effectiveness or efficiency of these sector-specific activities. The report

points to the best practice established in the sector of medical devices where market

surveillance relies on the use of an extensive database covering more than 500 000 products

and allowing information-sharing with healthcare agencies and businesses.

2.13

Cyprus

General market surveillance activities

General organisation: Cyprus refers to information reported in the 2014 national market

surveillance programme.

Overall resources: Cyprus does not report overall resources available, however the report

mentions between 200 and 290 000 EUR per year and slightly less than 5 full-time equivalent

units for staff (FTE) for low voltage electrical products, 150 000 EUR per year and 8 FTEs

for construction products. Lower resources are reported for eco-design and energy labelling

(increasing from 4 500 up to 39 000 EUR per year during the period), civil explosives (33 000

EUR per year), electronic magnetic compatibility (between 20 and 30 000 EUR per year),

pyrotechnical articles (22 000 EUR per year), aerosol dispensers (5-15 000 EUR per year) and

gas appliances (10 000 EUR per year). No resources were attributed for market surveillance

of radio and telecommunications equipment.

Own assessment: No specific assessment of the general organisation (e.g. cooperation and

coordination) is provided.

Market surveillance in specific sectors

Coverage: the Cyprus report covers about two-thirds of the products in the reference list.

Sectors excluded are: cosmetics, noise emissions for outdoor equipment, measuring

instruments, electronic and electronic equipment under restriction of hazardous substances,

waste from electrical and electronic equipment and batteries, chemicals, efficiency

requirements for hot-water boilers, recreational craft, marine equipment, non-road mobile

machinery, motor vehicles and fertilisers.

Distribution of resources: See section on resources above.

However pyrotechnics and civil explosives also come under the responsibility of the police.

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Own assessment: the Cyprus report contains an assessment of market surveillance carried out

by the Department of Labour Inspection of the Ministry of Labour in the sectors of personal

protective equipment, pressure equipment, machinery, lifts and equipment for use in

potentially explosive atmospheres, for which checks performed on products imported from

third countries are considered satisfactory. At the same time the these sectors are said to face

difficulties due to lack of traceability, mismatch between the customs product classification

and the nomenclature used by market surveillance authorities, a lack of financial resources to

conduct checks, and time-consuming procedures for imposing penalties.

Furthermore, market surveillance of radio and telecommunications equipment is considered as

inadequate due to underfinancing and understaffing of the Department of Electronic

Communications of the Ministry of Communications.

2.14 Latvia

General market surveillance activities

General organisation: Market surveillance in Latvia is handled by 11 different authorities

subordinated to 7 different ministries. To facilitate cooperation and exchange of information

between the authorities, a Market Surveillance Council was set up in 2000 at the Ministry of

Economics, and it meets twice a year. It is made up of representatives from all market

surveillance authorities and from the ministries under whose jurisdiction they operate.

Overall resources: The report provides estimates since it is not possible to indicate financial

resources dedicated to market surveillance because this is only a part of the responsible

authorities' activities. It is estimated that approximately 1.6 million EUR was available to

authorities in 2010 to 2.2 million EUR in 2013, which is a stable 0.03% of the national

budget. The number of full-time equivalent units for staff (FTE) available to market

surveillance authorities counted 101.3 FTEs in 2010 to 117.8 FTEs in 2013 in total. Between

74.5 and 83 FTEs were available for inspectors.

Own assessment: The Latvian report identifies the following challenges:



A lack of coordination of activities among Member States surveillance authorities with

respect to the release of goods for free circulation leading to situations where goods that

were not released onto the market in one Member State enter the market through

another one.

Insufficient cooperation with the Member States market surveillance authorities in cases

where the compliance of goods is being assessed or where irregularities have been

identified.

In practice there is not always cooperation between the market surveillance authorities

and the notified bodies.

A lack of resources to fully implement the EU's legal acts governing non-food goods.

A large number of importers are not aware of the requirements for imported goods.

The Consumer Rights Protection Centre (CRPC), State Labour Inspectorate, Health Inspectorate, State Agency for Technical

Surveillance, State Plant Protection Service, State Environment Service, Excise Goods Department of the State Revenue Service,

Customs Board of the State Revenue Service, Assay Office of Latvia, State Police, the Food and Veterinary Service (FVS).



463



The requirements are not differentiated for EU-manufactured or imported goods,

leading to situations where it is simpler to manufacture goods outside the EU as the

amount of checks that the surveillance authorities can perform on imported goods is

small.

Restricted resources lead to insufficient laboratory controls.

Inspectors find it challenging to ensure the fulfilment of the registration requirements of

chemical substances as stipulated in the REACH Regulation.

Market surveillance in specific sectors

Coverage: The Latvian report covers all sectors in the reference list (including non-

harmonised consumer products).

Distribution of resources: In general no information on the distribution of financial resources

per sector has been provided, with the exception of the chemical substances sector with a

budget of around 300 000 EUR and a staff availability of 12 full-time equivalent units (FTE)

in 2010 and 9.5 in 2013. The number of inspectors in the period has been fairly consistent of

around 8 FTEs with a drop in 2013 to 5.5 FTEs. The medical devices sector is mentioned with

a budget of approx. 37 000 EUR allocated in 2010 and 21 000 EUR in 2013. 2.5 FTEs have

been attributed in this period which went down to 1.5 in 2013. A consistent 1.5 FTEs to

inspectors has been available. Lastly the sector of electrical and electronic goods subject to

the low voltage directive is mentioned with figures ranging from 30 000 EUR to 31 000 EUR

for the years 2011 to 2013, with a consistent staff availability of 2 FTEs.

Own assessment: The report provides information on enforcement and communication

activities carried out in several sectors, and points to challenges faced. It does not provide for

an assessment of the effectiveness or efficiency of these sector specific-activities.

2.15 Lithuania

General market surveillance activities

Lithuania's report under Article 18(6) of the Regulation follows a different approach than the

one proposed by the Commission, as an extensive study to evaluate the national legal

framework was already launched in 2013.

General organisation: the Lithuanian report focuses on the legal framework for market

surveillance. This is characterised by the existence of: (ii) the Product Safety Law that acts as

a general 'umbrella' legal instrument regulating, among other aspects, market surveillance for

both (non-food

) products and services; (ii) special law regulating market surveillance for

certain product areas (e.g. metrology, pharmaceuticals) or certain specific aspects (e.g.

accidents at work, electronic communications, implementation of RAPEX system); (iii) by-

laws regulating in detail specific matters (e.g. rules on the application of restrictions on

marketing of products).

Overall resources: The Lithuanian study does not cover this information.

Own assessment: The purpose of Lithuania's study is to evaluate whether national law has

According to the Lithuanian study that the scope of the Product Safety Law in respect of foodstuff is unclear.

464

properly implemented the provisions of the Regulation. The study concludes that certain

aspects of the national legal framework should be improved. In particular, it notes that:



as the Product Safety Law only applies to consumer products, certain non-consumer

products may fall outside the scope of control powers. Furthermore, the legal technique

of resorting to by-laws to regulate powers to apply restrictive measures and sanctions

are not efficient: although the provisions of the EU Regulation apply directly, they are

not referred to in Lithuanian market surveillance legislation.

the legislation does not contain an approved and exhaustive list of market surveillance

authorities. In practice, the fact that the State Non-Food Product Inspectorate under the

Ministry of Economy is treated (except for products regulated by special laws) as an

'umbrella' market surveillance authority should help avoiding "grey areas" (i.e. cases

where the safety of consumer products is not controlled by any authority). However,

this responsibility of the Non-Food Product Inspectorate should be regulated by law.

Furthermore, there is no similar 'umbrella' authority in the area of non-consumer goods.

the legal framework regulating the function of coordination among authorities is

defective and could be improved by clearly clarifying and aligning the responsibilities

of both the ministries involved in the process and the market surveillance authorities,

and at the same time by establishing a model for cooperation (activity coordination).

the lack of clarity of the EU framework also create confusion. More detailed legislation

would be needed to clarify and regulate specific functions (e.g. authorities' obligation to

cooperate, accumulate scientific knowledge, monitor accidents) of the market

surveillance systems established by the EU Regulation.



Market surveillance in specific sectors

The Lithuanian study does not include information on enforcement and communication

activities carried out in specific sectors.

2.16 Luxembourg

General market surveillance activities

General organisation: In Luxembourg there are eight market surveillance authorities

. The

"Institut Luxembourgeois de la Normalisation, de l'Accréditation, de la Sécurité et qualité des

produits et services", ILNAS, is, since 2008, the market surveillance authority responsible for

the bulk of consumer products (i.e. toys, other consumer products falling under the GPSD,

low voltage electrical appliances, electromagnetic compatibility, radio and telecommunication

equipment eco-design and energy labelling) and for equipment for use in potentially explosive

atmospheres. On the other hand, the "Inspection du Travail et Mines", ITM, has, between

2010 and 2013, been the market surveillance authority responsible for personal protective

equipment, civil explosives, pyrotechnic articles, cableways, machinery, lifts, pressure

equipment, aerosols, gas appliances and construction equipment.

The responsibilities of

ILNAS and ITM cover about two-thirds of the sectors mentioned in the reference list.

ILNAS, Métrologie légale, Commissariat aux Affaires Maritimes, Direction du marché intérieur et de la consommation, Direction

de la Santé, ITM, Administration de l'Environnement, Département des transports

On 1 August 2014 the responsibility for market surveillance authority in these areas were transferred to ILNAS

465

ILNAS coordinates market surveillance at national level with the help of a national

committee.

Overall resources: Luxembourg reports that the complexity of the budgets of the different

administrations involved does not allow an estimation of the total amount of resources

dedicated to market surveillance. During the 2010-2013 period ILNAS' annual budget for

market surveillance (excluding the technical laboratory) ranged between 50 000 and 75 000

EUR. The budget declined over time. Total staff amounted to 6-7 full equivalent units (FTE).

The figure on ITM's market surveillance budget is not available. ITM's total staff amounted to

0.65-1.15 FTEs.

Own assessment: the Luxembourg report focuses on ILNAS achievements in the areas of

cooperation with customs (notably the agreement signed in 1998 and updated in 2012), the

exchange of data via a common Intranet (EC.SDM) and regular training on product safety and

legal requirements.

Market surveillance in specific sectors

Coverage: The Luxembourg report covers about two-thirds (19) of the sectors in the reference

list (29), as well as non-harmonised consumer products.

Distribution of resources: no information is available in addition to the data mentioned above

for ILNAS and ITM.

Own assessment: Luxembourg provides quite detailed information on ILNAS' market

surveillance activities and more succinct information on ITM's market surveillance activities;

however it does not contain a specific assessment of those activities. Resources available to

ILNAS are said to be insufficient to ensure effective market surveillance. The number of

inspectors went up by 8 units in 2014, together with a substantial increase in the

responsibilities of ILNAS.

2.17 Hungary

General market surveillance activities

General organisation: The report does not supply information on the general organisation of

market surveillance at national level but focuses on the activities of each of the authorities

separately. Surveillance is dispersed across various bodies, and responsibility for Community

harmonisation legislation is allocated according to jurisdiction. There are 14 market

surveillance authorities.

Overall resources: The overall resources are stipulated for 8 authorities running in the 2010-

2013 period to an annual global amount of 1.8 to 6.6 million EUR. This strong increase is

mostly due to a lack of information on the amount of resources in 2010. A similar calculation

gave 902 full-time equivalent units (FTE) in 2010 to 1496 FTEs in 2013 in total as the

number of staff available to market surveillance authorities. Between 274 and 568 FTEs were

available for inspectors.

Own assessment: No specific assessment of the general organisation (e.g. cooperation and

coordination) is provided.

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Market surveillance in specific sectors

Coverage:

Hungary’s report covers the sectors from the reference list (including non-

harmonised consumer products falling under the GPSD).

Distribution of resources: The report covers the distribution of resources per authority,

subdivided over most sectors (no calculation method is given). Budget allocated to most

sectors range between 1000 and 30 000 EUR per year covering a three-year time span and a

staff and inspector availability of between 1 and 4 FTEs. Next to toys (see section below) the

biggest sectors mentioned in terms of resource availability are the sector of electrical and

electronic goods subject to the low voltage directive with figures ranging from around 633

000 EUR to 672 000 EUR for the years 2010 to 2013, with a staff availability between 36 and

39 FTEs of which 30 and 32 FTEs for inspectors respectively. For the machinery sector a

budget of between 74 000 EUR and 169 000 EUR was available with a staff availability of 7

FTEs in 2010 and 9 in 2013. The number of inspectors in the period has been fairly

consistent, between 4 and 6 FTEs. For construction products the budget ranged between 64

000 EUR and 92 000 EUR, with 6 to 7 FTEs staff availability of which 4 FTEs for inspectors.

Further for personal protective equipment a budget between 38 000 EUR and 55 000 EUR is

reported with staff availability between 3 and 4 FTEs of which a consistent inspector

availability of 2 FTEs.

Own assessment: The report provides information on enforcement activities carried out by the

various market surveillance authorities. It does not provide for an assessment of the

effectiveness or efficiency of sector-specific activities.

2.18 Malta

General market surveillance activities

General organisation: Market surveillance tasks in Malta are carried out by the Market

Surveillance Directorate within the Technical Regulations Division of the Malta Competition

and Consumers Affairs Authority (MCCAA). The report does not provide additional

information on the organisation of market surveillance at national level.

Overall resources: in the 2010-2013 period the annual global resources for market

surveillance ranged between 0.15 and 0.18 million EUR. The staff dedicated to market

surveillance amounted to 5 full time equivalent units (FTE).

Own assessment: Malta does not provide a specific assessment of the general organisation of

market surveillance, although it notes that enforcement measures have been hindered by

inadequate testing facilities. The difficulty should be mitigated in future as the MCCAA is

asking for basic Market Surveillance screening equipment for toys, child care articles as well

as to a lesser extent other directives. Other challenges encountered concern:

–

the lack of traceability of products brought to Malta via EU intermediate economic

operators who import them from third countries. This also gives rise to the problem of

lack of documentation such as the Declarations of Conformity, owing to a breakdown in

communication between the operator in Malta and the manufacturer.

the lack of clarity of certain standards which give presumption of conformity to the

applicable EU Directives. This leaves room for different interpretations which are not

easily enforceable.

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–

Market surveillance in specific sectors

Coverage: The report covers all sectors in the reference list.

Distribution of resources: Overall resources are allocated according to priorities that depend

on the use of the product groups as well as the vulnerability of consumers. Hence, toys, plant

protection products and electrical appliances are given the highest priority due to the

widespread distribution of all three kinds of products, coupled with the vulnerability of

children and/or untrained consumers as well as the fact that plant protection products are

consumed in foods. Other product categories falling under the GPSD or the New Approach

Directives are given a secondary level of priority with less emphasis on proactive

enforcement. Lack of resources is mentioned as the reason for no or limited market

surveillance in sectors such as equipment for use in explosive atmospheres, civil explosives,

gas appliances, medical devices, transportable pressure equipment and construction products.

Own assessment: Malta provides detailed information on enforcement activities carried out in

most sectors; however in general the report does not provide for an assessment of the

effectiveness or efficiency of these sector-specific activities.

2.19

Netherlands

General market surveillance activities

General organisation: Market surveillance of products is organised between six national

market surveillance authorities

, each with their own sector of responsibility. Political

responsibility for the authorities lies with the Ministries of Economic Affairs (which also

coordinates and monitors the implementation of Regulation (EC) No 765/2008), Social

Affairs and Employment, Infrastructure and the Environment, and Health, Welfare and Sport

respectively.

Proactive inspections are carried out based on risk assessments (including compliance risk)

while reactive inspections are executed on the basis of RAPEX notifications, alerts from other

sources and complaints from businesses and consumers. Product examinations are executed

by the authorities' own laboratories as much as possible and tend to focus on manufacturers

and EU importers, taking into account (past) compliance behaviour of companies. All

authorities are also connected to ICSMS, with one national administrator.

Products are checked by the relevant market surveillance authority before they are released

for free circulation, and activities are coordinated with customs four to five times a year

through a national forum that was set up in 2008 (the Alliance Working Group on Product

Market Surveillance and External Border Controls) and which is chaired by the Netherlands

Food and Consumer Product Safety Authority (NVWA).

Overall resources: Overall, in the 2010-2013 periods, the total national budget for market

surveillance was estimated to be 20 million EUR. The staff dedicated to market surveillance

involves 175 full-time equivalent units (FTE) (the report does not provide further details).

Further resource information is provided for the Dutch Food and Consumer Product Safety

Authority, stating that the agency has a workforce of 110 FTEs in total, divided over 45

Social Affairs and Employment Inspectortae (I-SZW), Human Environment and Transport Inspectorate (ILT), the Netherlands

Radiocommunications Agency (AT), Verispect B.V., Health Care Inspectorate (IGZ), Netherlands Food and Consumer Product

Safety Authority (NVWA).

468

inspectors, 45 laboratory workers and 20 development and strategy employees. An annual

budget of around 11 million EUR is provided by the Health, Welfare and Sport ministry. The

Netherlands Radiocommunications Agency has a yearly budget of 1.6 million EUR per year,

with around 10 FTEs involved in market surveillance activities (of which roughly 6 for

inspectors). For the Social Affairs and Employment Inspectorate a staff count of 5.5 FTEs in

2010 is reported with an increase to 12 FTEs in 2013. The Inspectorate for Environmental

Affairs and Transport mentions 65 FTEs for market surveillance on a number of sectors EU

product legislation. Verispect mentions a budget of 0.2 million EUR market surveillance of

measuring instruments and a number of FTEs increasing from 0.3 in 2010 to 1.5 in 2013.

Own assessment: The report states that with Regulation (EC) No 765/2008 the market

surveillance of products has improved with better sharing and improvement of surveillance

methods between authorities, and better cooperation between national and international

agencies, while challenges still remain such as in E-Commerce where the Regulation is

deemed to be unclear on the legal grounds necessary to execute border controls on consumer

products for personal use in a third country.

Market surveillance in specific sectors

Coverage: the report covers the majority of sectors included in the reference list. The sectors

excluded are transportable pressure equipment, cableways, noise emissions for outdoor

equipment, pyrotechnics, efficiency requirements for hot-water boilers fired with liquid or

gaseous fuels, marine equipment, non-road mobile machinery and fertilisers.

Distribution of resources: the report does not provide this information.

Own assessment: The Netherlands provides an overview of the enforcement activities carried

out in a number of sectors, although it does not provides the details about inspections

requested in the Commission template. Furthermore, the report does not provide for an

assessment of the effectiveness or efficiency of the sector-specific activities but it does so for

the authority Netherlands Radiocommunications Agency where its market surveillance is

assessed as adequate and has improved over time.

Information-led and risk-oriented surveillance has been integrated into the operations and the

agency is held publicly to account for the work performed. More information is warranted

according to the agency to make further improvements and internet surveillance could be

improved and better deployed in market surveillance. Challenges lie with the private imports

of non-conforming equipment for personal use by consumers and the execution of the new

regulatory framework for both the electromagnetic compatibility directive and the revised

radio equipment directive will require the necessary capacity.

2.20 Austria

General market surveillance activities

General organisation: Depending on the legal provisions that apply to a given product, market

surveillance is exercised either by federal or by provincial authorities. The responsibilities of

the Federal Government are dealt with by default in the form of indirect federal

administration

(i.e. the executive powers of the Federal Government are exercised in the

provinces by the provincial governor and the provincial departments), except if the Federal

This concerns around 100 district administration authorities across the nine federal provinces.

469

Constitution attributes them explicitly to federal authorities. Therefore depending on the

sectors, market surveillance in Austria is carried out by provincial authorities either exercising

their own powers or through indirect administration, or by federal authorities.

The Federal Ministry for Science, Research and Economy coordinates the Austrian market

surveillance authorities pursuant to Regulation (EC) No. 765/2008. This Decision, however, is

without prejudice to the responsibility of the relevant department or province for the content

of each part of the programme. A permanent Market Surveillance Coordination Body

composed of representatives of federal and provincial market surveillance authorities and

customs acts as a communication and coordination forum.

Overall resources: Austria considers that examining the amount of resources used is not a

particularly helpful way to assess market surveillance, as it focuses on expenditure rather than

results. Furthermore, in the case of indirect federal administration it is impossible to

determine the specific budget allocated to market surveillance as the same staff performs a

wide range of tasks. Nevertheless in the area of measuring instruments for which the

responsible authority is the Federal Ministry of Science, Research and Economy, Austria

mentions an annual budget of between 0.8 and 0.9 million EUR and a staff of 15 full-time

equivalent units (FTE) during the 2010-2013 period.

Own assessment: Austrian assessment focuses on the effectiveness of sectoral market

surveillance (see below). No specific assessment of the general organisation (e.g. cooperation

and coordination) is provided.

Market surveillance in specific sectors

Coverage: the Austrian report covers the large majority (about four-fifths) of sectors included

in the reference list. The sectors excluded are transportable pressure equipment, cableways,

energy labelling, non-road mobile machinery, equipment for use in potentially explosive

atmospheres, electrical and electronic equipment under restriction of hazardous substances,

waste from electrical and electronic equipment and batteries directives.

Distribution of resources: the Austrian report does not include this information.

Own assessment: Austria considers that according to Article 19 of Regulation (EC) No.

765/2008, the extent of market surveillance activities must follow the principle of risk

assessment, that is it should depend on the potential of a certain type of product to endanger

public interests in a case of non-compliance. Since this potential varies considerably from

sector to sector, the level of market surveillance activities must also vary.

Against this background the Austrian report considers that market surveillance functions well

in the country and resources are being employed effectively. For the directives whose focus is

on user safety, the effectiveness of market surveillance would be substantiated by the

extremely low number of accidents caused by defective products recorded in the IDB (Injury

Database). For the other directives, whose purpose is not the safety of individuals, but for

example measurement accuracy, environmental protection, or an effective use of the radio

spectrum, this would be proven by the low number of serious complaints. The fact that a

relatively high proportion of non-compliant products was nevertheless found during

inspections testifies to the expert knowledge and motivation of the inspectors, and is not a

direct reflection of the market situation.

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2.21 Poland

General market surveillance activities

General organisation: Poland refers to the information on the general organisation of markets

surveillance provided in the national programmes. In Poland, the Office of Competition and

Consumer Protection (OCCP) carries out, monitors and coordinates market surveillance

activities. It further cooperates with customs and 9 other market surveillance authorities

The Market Surveillance Steering Committee is in place to develop cooperation between the

authorities involved in the national product control system, share experiences and

information, and increase the national system's effectiveness through the harmonisation of

procedures applied by the authorities. Representatives of all the authorities participate in the

yearly Committee meetings, as does the Ministry of Finance (representing customs) and the

Ministry of Economy (responsible for legislative matters).

Overall resources: It is estimated that approximately 8.8 million EUR was available to

authorities in 2010 to 10.2 million EUR in 2013, which is a somewhat stable 0.0013% of the

national budget. The number of staff available to market surveillance authorities counted 2424

full-time equivalent units (FTE) in 2010 to 2477 FTEs in 2013 in total. Between 1549 of

which 1389 FTEs were available for inspectors.

Own assessment: The report mentions that with restricted resources (financial and staffing),

market surveillance authorities establish control priorities on the basis of risk analysis. Given

these constraints however, the current system is approved of and further systematic

cooperation of authorities with customs has contributed to an increase in the effectiveness of

the general market surveillance organisation as well.

Market surveillance in specific sectors

Coverage: The Polish report covers all sectors in the reference list, except efficiency

requirements for hot-water boilers, motor vehicles and tyres and non-road mobile machinery.

Distribution of resources: the report does not include this information.

Own assessment: Poland provides extensive information on enforcement and communication

activities carried out in most sectors and points to challenges faced. In general the report does

not provide an assessment of the effectiveness or efficiency of these sector-specific activities.

2.22 Portugal

General market surveillance activities

General organisation: Pursuant to Regulation (EC) No 765/2008, market surveillance is

handled by 8 authorities

each with their own sector(s) of responsibility. The report further

National Labour Inspectorate (PIP), Office of Electronic Communications (UKE), Inspection for Environmental Protection (IOS),

Rail Transport Inspection (UTK), Construction Audit Authority (ONB),State Mining Authority (WUG), Independent Maritime

Offices (UM), Road Transport Inspection (ITD), Office for Registration of Medical Products, Medical Devices and Biocidal

Products (URPL).

Authority for Food and Economic Safety (ASEA), National Authority for Medicines and Health Products (INFARMED), National

Communications Authority (ICP-ANACOM), Mobility and Land Transport Institute I.P. (IMT), Directorate-General for Natural

Resources, Safety and Maritime Services (DGRM), National Directorate for the Public Security Police (DNPSP), Regional

Inspectorates for Economic Activities

–

Azores and Madeira respectively (IRAE).

471

mentions that external border control is assigned to the Tax and Customs Authority which is

not considered a market surveillance authority.

Overall resources: This information is not included in the report but the resources for some of

the market surveillance authorities are given. On the basis of the information supplied, ASEA

is the biggest authority in budgetary terms. Its budget ranged from approximately 25 million

EUR in 2010 to almost 21 million EUR in 2013. Staff available to market surveillance

authorities ran up to 526 full-time equivalent units (FTE) in 2010 to 500 FTEs in 2013.

Between 277 and 249 FTEs were available for inspectors. ICP-ANACOM's budget ranged

from 1.3 million EUR in 2010 to 1.6 million EUR in 2013 with 9 to 10 FTEs for staff (6 to 7

FTEs for inspectors). For INFARMED a budget of 1.6 million EUR to 1.1 million EUR is

mentioned, with 23.5 to 22 FTEs for staff of which 22.5 to 19.5 FTEs for inspectors.

Own assessment: The report does not provide an assessment of the effectiveness or efficiency

of the general market surveillance organisation.

Market surveillance in specific sectors

Coverage: the report covers the majority of sectors included in the reference list. The sectors

excluded are transportable pressure equipment, lifts, cableways, equipment for use in

potentially explosive atmospheres, chemicals, eco-design and energy labelling, efficiency

requirements for hot-water boilers and motor vehicles and tyres,

Distribution of resources: the Portuguese report does not include this information.

Own assessment: The report provides extensive information on enforcement and

communication activities carried out in most sectors and points to challenges faced. In general

the report does not provide an assessment of the effectiveness or efficiency of these sector-

specific activities.

2.23 Romania

General market surveillance activities

General organisation: Market surveillance in Romania is handled by 14 different market

surveillance authorities. Coordination and exchange of information between the authorities is

facilitated by the Ministry of Economy, Trade and Business Environment which has set up a

Coordinating Committee consisting of representatives of market surveillance authorities,

customs authority and the national standardisation body.

Overall resources: This information is not included in the report but the resources for some of

the market surveillance authorities are given. The State Inspectorate for Construction (the

market surveillance authority for construction products except for fixed fire-fighting systems

–

fixed systems for fire alarm/detection, for fire-fighting, for fire and smoke control and for

explosion protection) had a budget allocation of approximately 681 000 EUR in 2010 that was

more halved to 300 000 EUR in 2013. Personnel availability in 2010 was 50 full-time

equivalent units (FTE), decreasing to 18 FTEs in 2013.

The Ministry of Agriculture and Rural Development's budget for market surveillance

activities (responsible for surveillance in the area of fertilizers) ranged from 289 000 EUR in

2010 to 327 000 EUR in 2013 with 53 to 48 FTEs for staff (53 to 48 FTEs for inspectors). For

the Labour Inspection (responsible for issues relating to occupational health and safety and to

472

work relations) a budget of approximately 205 000 EUR is reported for 2010 rising to 280

000 EUR in 2013. Staff allocation is at a stable 22 FTEs. Further, for the National Authority

for Management and Regulation in Communications (ANCOM), focussing on

electromagnetic compatibility and radio equipment and telecommunications terminal

equipment, a budget for 2010 and 2013 of 75 000 EUR is reported, with a stable FTE count of

5 for staff, of which 4 for inspectors.

Own assessment: The report does not provide an assessment of the effectiveness or efficiency

of the general market surveillance organisation.

Market surveillance in specific sectors

Coverage: The report covers all sectors in the reference list except for medical devices.

Distribution of resources: Figures are provided for a few sectors. Budget allocated to

recreational craft and marine equipment was approximately 128 000 EUR and dropped to 63

000 EUR from 2010 to 2013 with the staff and inspector availability following from 5 to 3

FTEs. For electromagnetic compatibility and radio equipment and telecommunications

terminal equipment, the budget remained relatively stable between 2010 and 2013 with 75

000 EUR, with 5 FTEs for staff (of which 4 FTEs for inspectors). Fertilizers had a budget

available from approximately 290 000 EUR in 2010 to 327 000 EUR in 2013. Staff

availability (including that for inspectors) ranged from 53 FTEs in 2010 to 48 FTEs in 2013.

The biggest sector mentioned is that of construction products with a budget available of 680

917 EUR in 2010 and falling to 299 320 EUR in 2013,with staff availability following that

trend from 50 in 2010 and 18 FTEs in 2013 (of which 49 and 18 FTEs for inspectors).

Own assessment: The report provides extensive information on enforcement and

communication activities carried out in most sectors. In general the report does not provide an

assessment of the effectiveness or efficiency of these sector-specific activities. The lack of

certified laboratory in certain fields is mentioned as a challenge for market surveillance. In the

sector of fertilisers the authorities noted the limits represented by the lack of transport means

and resources to pay laboratory tests.

2.24 Slovenia

General market surveillance activities

General organisation: Market surveillance in Slovenia is handled by 9 different market

surveillance authorities

subordinated to 6 different ministries. Political responsibility for the

authorities lies with the Ministries of Health, Labour, Interior, Agriculture Forestry and Food,

Infrastructure and Spatial Planning and the Ministry of Economic Development and

Technology respectively.

The latter Ministry is responsible for the implementation of Regulation (EC) No 765/2008

and coordinates the work of the inspectorates and oversees the exchange of information

within a Working Group that is made up of representatives of all market surveillance

authorities and representatives of the Customs Administration. It meets twice a year or as

necessary.

Market Inspectorate of the Republic of Slovenia (TIRS), Metrology Inspectorate, Health Inspectorate, Chemicals Office, Public

Agency for Medicinal Products and Medical Devices (JAZMP), Labour Inspectorate, Internal Affairs Inspectorate (IRSNZ),

Agriculture and Environment Inspectorate, Transport, Energy and Environment Inspectorate.

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The report further mentions that the Customs Administration has, on the basis of EU

Guidelines for import controls in the field of product safety and conformity, drawn up a

catalogue of measures (e.g. on the release of the free circulation of goods) that supports

cooperation between customs authorities and the responsible surveillance authorities.

Overall resources: This information is not included in the report.

Own assessment: The Slovenian report mentions that, between 2010 and 2013, improvement

has been made in the knowledge of the requirements of Regulation (EC) No 765/2008 and

cooperation in accordance with these requirements. The cooperation between the inspection

services for surveillance of products in use and the inspection service responsible for

surveillance for products on the market has been reinforced. Further, cooperation between the

customs authorities and the inspectorates has been strengthened.

The report also mentions that progress has been made on building a stronger knowledge base

on RAPEX and ICSMS where TIRS is the contact point for RAPEX, and the ICSMS falls

under the responsibility of the Ministry of Economic Development and Technology. The

relevant supervisory authorities exchange information with authorities from other Member

States through various available fora and working groups such as PROSAFE and ADCO

groups.

The report mentions that there is a lack of resources for the implementation of surveillance

activities, in particular the testing of products, in combination with a lack of human resources,

creating a strain on participation in working groups and in general creating an incomplete

picture of the state of affairs in surveying products on the market.

Market surveillance in specific sectors

Coverage: The report covers all sectors in the reference list except for efficiency requirements

for hot-water boilers.

Distribution of resources: Figures are provided for some sectors. Budget allocated to most

sectors range between approximately 3000 and 60 000 EUR per year in the period 2010-2013

and a staff and inspector availability between 0.5 and 7 full-time equivalent units (FTE).

Own assessment: The report provides information on enforcement and communication

activities carried out in most sectors. It does not provide an assessment of the effectiveness or

efficiency of these sector-specific activities.

2.25 Slovakia

General market surveillance activities

General organisation: Slovakia provides extensive information on the general organisation of

market surveillance. Market surveillance activities pursuant to Regulation (EC) No 765/2008

rest with several ministries. The organisation of market surveillance in Slovakia can be split

into two large groups: consumer products and products used by businesses. As a result there

are often two surveillance authorities responsible for the enforcement of a given piece of

harmonisation legislation (e.g.; personal protective equipment, machinery). However certain

products such as medical devices and cosmetics fall under the responsibility of a single

surveillance authority, regardless of whether they are consumer or professional products.

474

The Slovak Trade Inspectorate, which acts under the control of the Ministry of Economy

, is

the market surveillance authority for most non-food consumer products.

The National Labour Inspectorate (under the control of the Ministry of Labour, Social Affairs

and Family) is, together with 8 regional labour inspectorates, the market surveillance

authority for most professional products.

The State Institute for Drug Control and the Public Health Authority

(both under the control

of the Ministry of Ministry of Health) are the surveillance authority for medical devices and

cosmetics respectively.

The Regulatory Authority for Electronic Communications and Postal Services and other

authorities under the control of the Ministry of Transport, Construction and Regional

Development are the surveillance authority for radio and telecommunications equipment and

electromagnetic compatibility, motor vehicles, cableways, marine equipment and other

products.

The Slovak Metrological Inspectorate (under the control of the Slovak Office of Standards,

Metrology and Testing) is the surveillance authority for measuring instruments and pre-

packaging.

The Slovak report describes the way each of these authorities works.

The authorities cooperate in the organisation and performance of inspections and exchange

information on the basis of bilateral agreements. Intra-sector vertical coordination is ensured

by individual authorities, which provide guidelines and training to inspectors, and direct their

activities.

Overall resources: According to the Slovak report it is not possible to distinguish within the

budget of each authority the share of resources allocated to market surveillance from other

tasks. The same can be said for staff.

In the 2010-013 period the total annual budget and staff of the Trade Inspectorate amounted to

4.6 million EUR and 252 full-time equivalent units (FTE).

The National Inspectorate employed overall between 109 and 150 staff per year, and

estimates that among them about 18

FTEs carried out market surveillance. As expenditure

per employee (including wages, goods and services) was approximately 18 800 EUR, it is

understood that resources for market surveillance in the area of professional products could

possibly be estimated around 0.3 million EUR

The Public Health Authority and the regional authorities estimate that, out of an overall

annual budget of between 30 and 33 million EUR, about 0.2-0.35 million EUR were

dedicated to market surveillance in the cosmetics area; furthermore, they employed more than

2000 staff, about 150 of which provided market surveillance for cosmetics, alongside other

The Ministry’s responsibility also encompasses the Main Mining Office, which carries out the state surveillance of the explosives

market.

The Trade Inspectorate is the sole surveillance authority only in relation to toys, pyrotechnics, construction products, electrical

appliances and equipment under the low voltage directive, gas appliances, and the labelling of products and recreational craft.

Together with 36 regional public health authorities.

16 inspectors from regional labour inspectorates and 2 employees of the National Inspectorate.

This figure is not explicitly provided by the Slovak report, but corresponds to the value of the multiplication of estimated full-

equivalent units of staff for market surveillance and expenditure per employee.

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activities, such as official inspections of foodstuffs.

The State Institute for Drug Control had a total budget between 3.7 and 4.2 million EUR and

overall FTE count between 165 and 196 per year.

Own assessment: Slovakia rates positively the functioning of its market surveillance

activities. During the reporting period there were no serious threats to the health and safety of

the public or other public interests.

The financial resources allocated by ministries to surveillance authorities for their activities

were limited and central government budget rules do not permit an increase in financial

resources for market surveillance authorities. Lack of funds particularly affects laboratory

testing. Therefore, the market surveillance authorities, in cooperation with the relevant

ministries, jointly assessed the market situation in Slovakia and adapted their activities to

topical issues.

Slovakia makes use of all possibilities of cooperation with other EU Member States. The

situation would be eased if EU legislation were simplified and streamlined in the field of

market surveillance concerning harmonised legislation.

Cooperation between authorities, including vertical intra-sector cooperation, is considered

effective. So far, there has been no acute need to establish a nationwide coordinating body for

market surveillance. This option will be considered after the new EU market surveillance

regulation has been adopted.

Cooperation between market surveillance authorities and customs authorities has improved

considerably at the end of the reporting period. This can be attributed in part to an initiative of

the Commission (DG TAXUD), which produced manuals for customs officers and promoted

cooperation between customs authorities and market surveillance authorities. Individual

surveillance authorities have signed cooperation agreements with customs authorities. They

exchange information on dangerous products, work together on inspections and organise joint

training for their employees.

Market surveillance in specific sectors

Coverage: The Slovak report covers half of the sectors in the reference list. Sectors excluded

are pressure equipment, aerosols, machinery, lifts, equipment for use in potentially explosive

atmospheres, electromagnetic compatibility, radio and telecommunications equipment,

electrical equipment under restriction of hazardous substances, waste from electrical and

electronic equipment and batteries, efficiency requirement for hot-water boilers, marine

equipment, motor vehicles, non-road machinery and non-harmonised consumer goods

(optional).

Distribution of resources: As mentioned in the section on overall resources, according to

Slovakia the resources available to market surveillance cannot be easily distinguished from

those related to other tasks. A comparison of resources allocated to market surveillance in

different sectors cannot be done, however estimates of staff carrying out market surveillance

(alongside other activities) in different sectors are given. Excluding medical devices and

cosmetics for which no specific estimates are provided, the biggest number of employees

work in the sectors of toys, personal protective equipment and low voltage products, together

with eco-design/energy labelling.

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Own assessment: Slovakia considers that in the reporting period, there were no serious

deficiencies in the operation and functioning of market surveillance authorities or situations

threatening the health and safety of consumers, professional users and other public interests,

and therefore rates positively the overall functioning of market surveillance. Apart from a few

exceptions, such as for cosmetics products, a more specific assessment of the activities carried

out in a given sector is not provided.

The biggest problem in the area of consumer products falling within the scope of Regulation

(EC) No 765/2008 concerns the traceability of individual businesses in the distribution chain.

As Slovakia has few manufacturers of consumer products, inspections must focus on

distributors and retailers. Most consumer products were manufactured in third countries and

entered the Slovak market from other Member States. It was virtually impossible to identify

the importers and, sometimes, distributors of such products. Slovakia also notes that the

application of Article 21(1) and (2) of Regulation (EC) No 765/2008 tends to be abused by

economic operators, and this hampers market surveillance.

In some sectors (low voltage electrical products) the insufficient definition of product ranges

by Custom Tariff codes has prevented the ability to draw risk profiles to be used for checks by

customs.

2.26 Finland

General market surveillance activities

General organisation: Finland refers to information provided in the general national

programmes. There are nine market surveillance authorities in Finland (i.e. seven sectoral

authorities, the National Police Board and Customs). Over the 2010-2013 period it appears

that some of the tasks previously conducted by other authorities were transferred to the

Finnish Safety and Chemical Agency (Tukes).

The Ministry of Employment and Economy carries out coordinative tasks related to market

surveillance and is responsible for the coordination of the national implementation of

Regulation (EC) 765/2008. The Ministry is supported by the Advisory Board of Conformity

Assessment Affairs that brings together the different authorities as well as stakeholders.

Market surveillance is mostly conducted at central authority level, although there are

exceptions to this (e.g. market surveillance of certain professional products is conducted by

the Department for Occupational Safety and Health at the Ministry of Social Affairs and

Health, as well as Regional State Administrative Agencies’ occupational health and safety).

Overall resources: Between 2010 and 2013, Finland devoted between 7.2 and 7.7 million

EUR per year to market surveillance. Overall staff available to market surveillance can be

estimated at around 90-93 full-time equivalent units (FTE), including customs officials.

Despite some fluctuations the annual budget for the market surveillance authorities remained

fairly constant over the 2010-2013 period. Staff figures diminished very slightly.

Own assessment: Finland considers that cooperation between different market surveillance

authorities through the different discussion forums was efficient. Also cooperation with

customs worked well.

Finnish authorities used the RAPEX and ICSMS systems actively (for instance 222 RAPEX

notifications were made in 2013).

477

The report mentions the challenge provided by on-line sales by economic operators located

outside the EU. It also mentions that in some sectors formal requirements such as technical

documentation and CE marking are disregarded by businesses, possibly due to a lack of

knowledge or understanding of those requirements.

Market surveillance in specific sectors

Coverage: The Finnish report covers all sectors indicated in the reference list (including non-

harmonised consumer product), with the sole exception of non-road mobile machinery.

Distribution of resources: The sector to which the greatest part by far of resources was

allocated is low voltage electrical appliances and equipment (between 1.1-1.4 million EUR

per year and 7-8 FTEs). This was followed by toys (0.78 million EUR and 13 FTEs) and

other consumer products falling under the General Product Safety Directive (0.7 million EUR

and 11.5 FTEs), construction products (0.6-0.7 million EUR and 5.5 FTEs), eco-design and

energy labelling

(0.3-0.5 million EUR and 3 FTEs), radio and telecommunications

equipment (0.5-0.17 million EUR and 4-1.5 FTEs), recreational craft (0.3-0.4 million EUR

and 4 FTEs) and pressure equipment (0.3 million EUR and 2.2-3.2 FTEs).

Own assessment: Finland provides extensive information on enforcement and communication

activities carried out in most sectors. It reports that market surveillance activities have been

carried out according to market surveillance programmes. Depending on the sectors, market

surveillance is either carried out proactively or exclusively in response to complaints. In

different sectors it is also noted that the level of market surveillance is regarded as sufficient,

although the report does not detail the specific criteria used for the assessment (e.g. market

sizes, estimate of potential non-compliance). Efficient surveillance was carried out in some

areas such as toys (38 recalls and 20 withdrawals in 2010-2013), personal protective

equipment (26 recalls and 32 withdrawals), non-harmonised consumer products (70 recalls

and 40 withdrawals), machinery (22 recalls and 23 withdrawals), despite the relatively limited

amount of resources. Very efficient surveillance was also carried out regarding electrical

appliances and equipment under LVD (224 recalls and 437 withdrawals). Due to lack of

resources in some sectors markets surveillance was very selective in comparison to market

size (medical devices, motor vehicles, eco-design and energy labelling restriction of

hazardous substances, waste from electrical and electronic equipment and batteries). The

absence of an administrative cooperation group (ADCO) complicates the possibility of cross-

border cooperation in the sectors of marine equipment and motor vehicles.

2.27 Sweden

General market surveillance activities

General organisation: Sweden refers to the information on the general organisation of market

surveillance provided in the national programmes. Market surveillance is carried out by 16

public authorities and 290 municipalities. The Swedish Board for Accreditation and

Conformity Assessment (Swedac) is responsible for coordination, including presiding over

the Market Surveillance Council that consists of the 16 authorities as well as the Swedish

Customs and the Swedish National Board of Trade. It also functions as the national

administrator for ICSMS, whereas the Swedish Consumer Agency is the contact point for

RAPEX.

Including checks for hot-water boilers efficiency requirements.

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Overall resources: Between 2010 and 2013, Sweden allocated between 10.4 and 14.3 million

EUR per year to market surveillance. Overall staff available to market surveillance almost

doubled and is estimated at approximately 43.5 in to 2010 to 91.5 full-time equivalent units

(FTE) in 2013. There is no distinction made for inspectors since at most Swedish market

surveillance authorities no particular distribution of occupational categories exists.

Own assessment: The report mentions that, even though there is room for improvement,

cooperation between market surveillance authorities works well. Given that various

authorities are responsible for various aspects of the same product, close cooperation is

deemed important by Sweden to achieve effective market surveillance.

Many authorities are actively engaged in disseminating information to economic actors, and

their cooperation is functioning well and voluntary corrective actions are common. Further,

cooperation between authorities and the Swedish Customs has shown a steady improvement

over the years.

Cooperation on a European level works well but the administration that is involved in joint

projects is seen as burdensome making, it difficult for authorities to prioritise this cooperation

in their activities.

Drawing definitive conclusions on how market surveillance is functioning is challenging but a

conclusion that may be drawn is that formal non-compliance is common in most sectors while

deficiencies in compliance with basic product requirement vary from one sector to another.

A challenge that is mentioned is that authorities find it cumbersome to report via different

information exchange systems and a single integrated system would be welcomed. Also the

report mentions on-line sales by economic operators located outside the EU is a challenge.

Market surveillance in specific sectors

Coverage: The Swedish report covers all sectors indicated in the reference list (including non-

harmonised consumer products).

Distribution of resources: The biggest sector of resource allocation that is mentioned in the

report is medical devices with a budget ranging from 3 million EUR in 2010 to 4 million EUR

in 2014 and a staff allocation of approximately 25 FTEs. The cosmetic products sector is

mentioned with around 1.1 million for the years 2012 and 2013 with a staff allocation of 8.75

FTEs and 7.5 FTEs, of which for inspectors 5.75 and 4.5 FTEs in 2012 and 2013 respectively.

The construction products sector shows a drop in budget from 1.7 million EU in 2010 to 715

000 EUR in 2013 but an increase in staff from 2 to 4.5 FTEs. Other sectors mentioned are

radio and telecommunications (approx. 0.7 million EUR and 1.5 FTEs), low-voltage

equipment (approx. 0.6 million EUR

–

0.7 million EUR and 5.7 FTEs), electrical equipment

(approx. 0.1 million EUR and 1.1 FTEs), measuring instruments (approx. 0.4 million EUR

–

0.95 million EUR and 4-6.5 FTEs) and other consumer products falling under the General

Product Safety Directive (approx. 0.25 million EUR per year and 1.5 FTEs).

Own assessment: The report provides information on enforcement and communication

activities carried out in most sectors. It qualifies the market surveillance activities in some

other sectors as working well or satisfactorily. The report does not detail the specific criteria

used for the assessment. However, for the medical devices sector for example it is stated that

market checks and penalties have contributed positively to compliance with regulations.

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2.28 United Kingdom

General market surveillance activities

General organisation: Information on the general organisation of market surveillance in the

UK can be found in the national programme. Exercised within a framework of local

autonomy, market surveillance generally has been divided between the Health and Safety

Executive (HSE) which is responsible for products in the workplace (functions as the national

administrator for ICSMS as well) and the UK's Local Authorities' Trading Standards

Departments, responsible for consumer product safety. The Medical Devices Regulations and

related legislation are enforced by the Department for Health's (DH) specialist Medicines and

Healthcare products Regulatory Agency (MHRA). Automotive-related products are the

responsibility of the Department for Transport's Vehicle and Operator Services Agency

(VOSA). Non-safety legislation is enforced through a number of sector-specialist bodies.

The UK's National Market Surveillance Coordination Committee is responsible for

coordination and has set up an MSCC Stakeholders Group to create dialogue between the

members of the MSCC, business and other interested parties. The UK Customs authorities

work closely with the MSA to identify products that are likely to present a risk, through a

targeted border controls approach.

Overall resources: The report states that because all of the UK MSAs are autonomous

enforcement bodies and the market surveillance network is diverse, it is not feasible to

provide data about the overall resources.

Own assessment: The report does not provide an assessment of the effectiveness or efficiency

of the general market surveillance organisation.

Market surveillance in specific sectors

Coverage: The report contains statistics on enforcement activities carried out by the UK

Trading Standards local authorities in the areas of toys, electrical appliances, cosmetics and

childcare articles for 2011 (approximately 60% of Trading Standards responded) and 2012

(approximately 93% of Trading Standards responded).

Distribution of resources: The report does not include this information.

Own assessment: The report provides information on enforcement and communication

activities carried out in some sectors. The report does not provide an assessment of the

effectiveness or efficiency of these sector-specific activities.

AIN

INDINGS

All

Member States fulfilled the obligation

to submit reports in accordance with Article

18(6) of Regulation (EC) 765/2008 and most

Member States were able to provide a

significant amount of information,

despite the understandable difficulties of the exercise

(notably, the relatively short time available to discuss the common indicators and to collect

information).

The information provided is

valuable as it provides better and useful insights into the

practical enforcement of product legislation in the EU for the first time.

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The examination of the reports submitted in this first round of national reviews and

assessments shows that the

level of detail of information provided varies from Member

State to Member State.

Critical factors in this respect have proven to be the sector-specific

focus and the range of sectors covered. The reports, which followed the sector-focused

approach proposed by the Commission cover a wider range of sectors and contain in general

more accurate and complete information on the enforcement activities carried out.

The following main findings are based on the results of the exercise and the efforts needed to

pursue the correct implementation of the Regulation. They are not recommendations or

conclusions. Rather this section is to be seen as a synthetic overview of all the information

gathered and possible follow up that can be derived thereof.

3.1

Main findings on sector coverage

As the scope of Regulation (EC) 765/2008 extends to all EU harmonisation legislation,

Member States were requested to include all product areas or sectors falling within this scope.

To this end the template prepared by the Commission provided a reference list of 29 sectors

which Member States were free to expand, and also covering market surveillance activities

carried out in relation to non-harmonised consumer products falling within the scope of the

General Product Safety Directive. On the other hand, the Commission indicated that the

inclusion of market surveillance activities in relation to chemical products within the scope of

Reach and Classification and Labelling Regulations was not considered necessary because of

the detailed reporting and assessment already carried out and made public according to the

specific provisions of this legislation.

Against this background most Member States have provided detailed information on

enforcement activities carried out in the majority of sectors. Even though the actual coverage

of national reports varies between Member States, the following snapshot can be made for the

ones that followed the common template established by the Commission:

All or almost all sectors

were covered by Latvia, Finland, Sweden, Slovenia, Denmark,

France, Malta, Bulgaria, Poland, Czech Republic, Romania, and Hungary.

More than two thirds of sectors

were covered by Austria, Greece, Estonia, Belgium,

Ireland, Portugal and Cyprus.

About half of the sectors

were covered by Slovakia, Italy and Luxembourg.

Less than half of the sectors

were covered by Spain. The report however includes only

aggregate information on activities carried out for two macro areas encompassing

respectively products for consumers and professional users.

The products/legislation areas most often left out of national reports are:

Non-road mobile machinery

(Directive 97/68/EC) and the efficiency requirements for

hot-water boilers fired with liquid or gaseous fuels pursuant to Directive 1992/42/EEC,

which are covered only by 7-8 Member States.

Transportable pressure equipment

(Directive 2010/35/EU), Noise emissions for

outdoor equipment (Directive 2000/14/EC),

Equipment and Protective Systems

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Intended for use in Potentially Explosive Atmospheres

(Directive 1994/9/EC), which

are covered only by 15-16 Member States.

A complete overview of the sectors covered by each national report is given in section 7.

As regards to some

countries that chose not to use the common template,

it is noted that,

in general they provided less detailed information on enforcement activities carried out

specific sectors.

In particular:

The report from Croatia covers activities concerning 12 of the 29 sectors included in the

reference list and provides some basic statistics on inspections and checks carried out.

The report from Germany in principle covers activities concerning 12 of the 29 sectors

included in the reference list (see detailed country overview); however, because those

activities are not presented on a sector-by-sector basis it is not possible to know

whether the information reported actually refers to all relevant product areas or only

some of them.

The report from the Netherlands in principle covers activities concerning 21 of the 29

sectors included in the reference list. However factual he information on activities

carried is provided only for a smaller set of sectors and is mostly of qualitative nature.

The report from the United Kingdom in general does not provide information on

inspections in specific sectors in the 2010-2013 period, except for toys, electrical

appliances, cosmetics and childcare articles.

The report from Lithuania provides an assessment of national legal framework and

therefore does not contain information on inspections carried in specific sectors.

Based on these findings it would be useful to understand from Member States the reasons

why a certain number of sectors were left out of the national reports. In some cases this may

be due to the fact that certain products may not be relevant in all countries (e.g. cableways,

marine equipment) or that Member States may not have intuitively considered certain pieces

of legislation as product harmonisation (e.g. Directive 1992/42/EEC on efficiency

requirements for hot-water boilers fired with liquid or gaseous fuels).

Apart from these special cases however the exclusion of a sector might be due either to a

lack

of structured market surveillance in the sector

(i.e. authorities make no interventions or

those interventions are sporadic and not recorded) or to

coordination problems within a

Member State

(i.e. the central authority responsible for the coordination of market

surveillance could not obtain the necessary input from the sector-specific authority).

In addition to the sectors included in the reference list, a number of the national reports also

included additional product areas (see detailed country-by-country overviews in section 3).

This suggests that it could be useful to

discuss with Member States the opportunity to

include additional sectors in the reference list of sectors for future exercises.

3.2

Main findings on the overall resources available to market surveillance

With regard to the template drawn up by the Commission, some of the Member States have

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indicated that the information on levels of resources could not be easily obtained. This is

because in many cases authorities responsible for market surveillance have at the same time to

carry out tasks of another nature, and the budget of those authorities does not earmark funds

for market surveillance.

The problem also affects the figures on staff, who are often asked to carry out different types

of tasks next to market surveillance in sectors falling within the scope of Regulation (EC)

765/2008.

Against this background, it is noted that:

The information on resources for market surveillance activities is

available

Denmark, Finland, the Netherlands, Poland and Sweden. It also available to a large

extent in France, albeit in a different format (distinction is made between budget and

staff dedicated to testing of products and other market surveillance activities).

The information is

partially available

for Italy (budget available only for the Minister

of Economic Development, staff available also for some additional Ministries), the

Czech Republic (budget available only for CTIA; staff available also for other

authorities although difficult to distinguish between market surveillance and other

tasks), Luxembourg (budget available only for ILNAS, staff available also for ITM ),

Estonia, Ireland, Latvia, Malta and Slovakia (an estimation of total budget and staff for

some but difficulty to distinguish between market surveillance and other tasks),

Bulgaria (budget and staff available for DAMTN and KZP), Cyprus (details on

resources available for about 10 sectors), Spain (estimation of the combined budget of

the consumer affairs authorities) and Portugal, Romania and Hungary (budgets available

for 4, 5 and 8 authorities respectively),

The information is

not available

for Austria and Belgium (impossible to determine the

budget allocated to market surveillance tasks carried out under indirect federal

administration), the United Kingdom (impossible to provide data on the overall

resources because all of the UK MSAs are autonomous enforcement bodies and the

market surveillance network is diverse), Germany (according to whom information on

the level of resources for market surveillance is not relevant to assess its effectiveness

and efficiency), Croatia and Slovenia (no specific reason specified).

In the case of Lithuania, it is not possible to say if resources for market surveillance are

known or not, since the report follows a different approach and therefore does not cover

this aspect.

This brief overview suggests that in a number of cases the availability of information on

resources for market surveillance could be improved by increasing transparency of resources

allocation within national authorities' budgets and by working out methods to estimate which

share of certain resources (e.g. staff) can be attributed to different activities. The difficulty of

estimating resources when market surveillance tasks are delegated to local authorities is less

clear and requires more in-depth investigation.

Information provided by Member States on the level of resources

should be interpreted

carefully

due to the significant gaps in information in some of the countries. In some, for

instance, resources mentioned concern only the central administration but do not take into

account local administrations or other police officers involved in inspections. Furthermore, it

483

is not clear if all budget figures provided include remuneration of staff as suggested in the

Commission's template. For these reasons the information provided can only be subject to

cross-country comparisons to a very limited extent.

Despite these limitations however, the information available provides interesting insights into

the importance attributed to the enforcement of product legislation by a given Member State

and represents a solid starting point for further enquiries. It also allows

for some insight into

whether authorities have in practice the means to accomplish the tasks attributed to

them.

Many Member States note that

resources for market surveillance are limited and lacking.

For instance, a lack of resources is claimed by Spain, Poland, Slovenia, Estonia, Denmark,

Italy, Czech Republic, Malta, Luxembourg, Slovakia, Bulgaria (budget for testing, expert staff

in certain sectors) and Cyprus. It would then appear useful for Member States to try and

estimate the amount of resources necessary

to increase the amount of enforcement to a

more satisfactory level and to take

initiatives to fill the resource gap.

3.3

Main findings on the assessment of market surveillance carried out by Member

States

–

discussion of evaluation criteria

According to Article 18(6) of Regulation (EC) 765/2008 the assessment of the functioning of

national market surveillance should be carried out by Member States.

The template prepared by the Commission was meant to help Member States to structure the

information in a manner that could facilitate its evaluation. The idea behind the template was

that reporting information on the general organisation of market surveillance (infrastructures,

distribution of competences, resources available) and sector-specific activities (information

and communication activities, number, type and outcomes of inspections) could help present

all the basic 'facts' to be assessed.

On the other hand the template left

Member States free to determine the relevant criteria

for the assessment

of their (general/sectoral) national market surveillance activities.

It is then interesting to observe that a number of Member States have actually interpreted the

requirement of Article 18(6) of the Regulation as for the most part a mere reporting

obligation, and have used the Commission template more as a questionnaire on possible

'indicators' of activities rather than as an aid for their own analysis and evaluation. As a result

of this, in many cases the reports provide sector-by-sector information but do not actually

evaluate

the amount and type of activities carried out.

However, the following few examples of assessments of market surveillance activities by

specific Member States are noted:

Austria considers that the overall level of market surveillance can be regarded as

sufficient in the light of the

low number of complaints

lodged with market surveillance

authorities and the

low number of accidents

recorded in the Injury Database.

Slovakia rates the functioning of market surveillance as generally positive since it

considers that in the reporting period there were

no serious deficiencies in the

operations of market surveillance authorities

or situations threatening the health and

safety of consumers, professional users and other public interests.

484

The Netherlands, Sweden, Denmark, Poland, Estonia, Slovenia and the Czech Republic

consider the market surveillance activities to be effective or satisfactory since

the

cooperation and coordination between authorities

is of such a level (or has

improved) that it has a positive impact on the overall success of surveillance activities.

Germany, Bulgaria and Finland consider market surveillance activities satisfactory as

they were carried out

according to market surveillance programmes.

Finland also points to the efficiency of market surveillance by comparing the number of

product recalls and withdrawals achieved in 2010-2013 with the relatively small level of

resources available during the same period.

Furthermore, specific attention should be devoted to the approach of Lithuania's

evaluation study. Interestingly, it had the objective to

assess whether national law has

properly implemented the EU requirements

for market surveillance laid down in

Regulation (EC) 765/2008 and makes suggestions on how to further improve the

national regulatory framework.

In light of the above, it would appear useful to discuss with Member States the advantages

and disadvantages of the different approaches to the assessment of market surveillance and to

build a common understanding on the relevant

evaluation criteria.

In this regard, the assessment of the market surveillance carried out in a given sector is also

expected to be connected to the

specific market context

in which the market surveillance

activities took place. For this reason figures on the number and type of inspections should be

analysed against the backdrop of the relevant estimates of the size of the national market for

the products concerned, the number of manufacturers/importer/wholesale or retail distributors

based in the Member States and, the volume of imports from other Member States or third

countries, and so on. This information seems among those necessary to assess the scale and

the reach of market surveillance activities.

The Commission also notes that the Lithuanian approach to evaluation introduces an

additional and interesting dimension to the discussion on the assessment of the functioning of

market surveillance.

3.4

Main findings on challenges faced by market surveillance authorities

Many national reports comment on major difficulties identified in the course of market

surveillance activities. One of them is certainly the lack of sufficient resources. Additional

common challenges appear to be the following:

Various reports (e.g. Denmark, France, Germany, the Netherlands, Czech Republic,

Finland, Bulgaria) note that current control procedures are not apt to handle

products

sold on line.

In this connection, for instance, Germany suggests that it is worth

considering whether, for internet commerce, there should be further accountable parties

beyond the economic operators defined in Regulation (EC) No 765/2008, for example

commercial platforms that do not fall within the current definitions of a distributor or

importer. Moreover, for effective market surveillance of products sold on the internet

and that are offered from outside the EU, collaboration with customs authorities is of

crucial importance.

Some reports stress the need to reinforce

customs controls.

In this respect Germany

485

notes that product-specific specialist knowledge must be available to a greater extent

locally at import control sites: risk profiles based on the findings of market surveillance

authorities have proven worthwhile, but an improvement would be possible, for

example, by conducting special training for customs officials or by posting market

surveillance specialists at customs offices for direct, joint customs clearance.

Furthermore, to make it harder for non-European manufacturers, whose non-compliant

products have been rejected by a customs authority, to switch to other customs

clearance locations, improved cooperation between the customs authorities of the EU

Member States also seems necessary). Slovakia and Cyprus point to the existing

mismatch between the customs product classification and the nomenclature used by

market surveillance authorities, which hamper cooperation in some areas (e.g. electrical

low voltage equipment, personal protective equipment, pressure equipment, equipment

for use in potentially explosive atmospheres, lifts and machinery).

France mentions insufficient

cross-border cooperation

in some sectors (i.e. equipment

for use in potentially explosive atmospheres, pyrotechnic articles, civil explosives and

gas appliances), as a difficulty to tackle when relevant economic operators are located

abroad. Finland mentions complications due to the lack of ADCOs for marine

equipment and motor vehicles.

Spain, the Czech Republic, Malta, Slovakia, Bulgaria and Cyprus note the lack of

traceability

information especially, when products are imported into the EU by

intermediaries located in other Member States

The Czech Republic notes the difficulty of dealing with products from third countries

sold via

informal channels

(marketplaces), and the ineffectiveness of market

surveillance techniques in this case.

Spain and Ireland note

that penalties

laid down in national law

might not be a

sufficient deterrent,

in particular in the case of larger companies trying to market non-

compliant products;

Estonia and Ireland note that

the non-existence of test laboratories

makes conformity

assessment difficult and costly.

Many reports mention

economic operators' lack of knowledge

about applicable

product rules. Finland for instance mentions that in some sectors formal requirements

such as technical documentation and CE marking are disregarded by businesses,

possibly due to lack of knowledge or understanding of those requirements. France

suggests a simplification of product legislation and the need to provide summaries of

legislation applicable to categories of products to be made available to businesses.

Bulgaria notes the

lack of cooperation by certain economic operators;

Slovakia refers

to businesses' abuses of the legal principles on the notification of restrictive measure

contained in Article 21 (1) and (2) of Regulation (EC) 765/2008.

France mentions the need to reduce the

administrative burden

for market surveillance

authorities (i.e. simplify current safeguard clause procedures for serious risk products by

using the Rapex system). Sweden notes that there is a demand for a single integrated

system since reporting in different information exchange systems is deemed

cumbersome and not always suitable.

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The reflections of the market surveillance authorities should guide current and future policy

initiatives in the on-going implementation of Regulation (EC) 765/2008.

3.5

Main findings on possible issues with current practice by market surveillance

authorities

The analysis of the specific information provided by Member States for the toys sector that is

conducted in the following section sheds light on some aspects of market surveillance

activities in practice. The Commission suggests a number of possible concrete follow-up

actions that could improve national enforcement of legislation in relation to potential gaps

identified. These actions could also be easily applied to other product areas. They have been

grouped by relevant area and can be summarised as follows:

Focus of market surveillance activities:

authorities to discuss and compare

methodologies for selecting proactive inspections and to screen information provided by

stakeholders; draw up a set of best practices; enquire into the accessibility and visibility

of national stakeholders' complaint procedures.

Follow-up to discovery of non-compliance:

enquire into reasons why a significant

number of inspections where non-compliance is found appear to be left without follow

up; enquire about criteria used by Member States to choose whether to apply sanctions

in addition to compulsory corrective action or not.

Cooperation with customs:

identify and overcome obstacles to cooperation between

customs and market surveillance authorities; discuss possibility to recognise customs as

markets surveillance authorities.

Cross-border cooperation:

enquire into obstacles to cross-border cooperation; inform

sector authorities of the mutual assistance principles of Regulation (EC) 765/2008;

make those principles operational by building up a common procedure.

ASE STUDY OF A SPECIFIC SECTOR

: T

OYS

This section showcases a more in-depth analysis of the information provided by Member

States in relation to market surveillance activities carried out during the 2010-2013 period in

the toys sector.

The reason why a single sector has been chosen is to demonstrate that with the correct use of

the template that was provided by the Commission, more insight into the difference and

commonalities of market surveillance activities by Member States on a sectoral level can be

discerned since the results of the analysis offer indications of the size and the type of

enforcement activities carried out in each country

. The objective is to shed a brighter light

on some aspects of market surveillance activities in practice.

4.1

On the number of product-related accidents, user and industry complaints

Information on the number of product-related accidents, user and industry complaints is

provided by 17 Member States out of the 28 that submitted a report according to Article 18(6)

of Regulation (EC) 765/2008. In half of them (Bulgaria, Ireland, France, Hungary, Malta,

Naturally differences between countries can partly be attributed to different levels/styles of enforcement activities and partly to

diverging interpretations of the indicators.

487

Portugal, Finland and Sweden) the average number of product-related accidents and

complaints per year is between 14 and 31; in four cases the average number is much higher

(215 for Poland, 212 for Italy

, 120 for Czech Republic and 90 for Slovakia); in four other

cases very few complaints are reported (4 for Denmark, 1 respectively for Greece and

Luxembourg, 0 for Romania and Cyprus)

The number and the importance of product-related accidents, user and industry complaints

provides indications to market surveillance authorities of the presence of possible non-

compliant products available on the market. These figures should be viewed in relation to the

population of each country and to the number of products made available in national markets.

The fact that a certain number of the Member States do not provide any information on

product-related accidents, user and industry complaints may however suggest that accidents

and complaints are not systematically recorded. It also raises the question about the

accessibility and visibility of national complaint procedures.

4.2

On the number of inspections

The average yearly number of inspections

reported for the period between 2010 and 2013

changes significantly from Member State to Member State (from 4 in Ireland to more than

2 800 in France). The following outlook is provided for groups of countries of broadly similar

number of inhabitants

Germany (81 million inhabitants): no information on toy inspections provided.

France, Italy and the UK (60-66 million inhabitants): France reports an average of

2 834 inspections per year

; Italy reports 1 115 inspections including however both

toys and other non-harmonised consumer products; the UK reports 1 482 per year.

Spain and Poland (38-46 million inhabitants): Poland reports 754 inspections per year

on average; no information on toys inspections is provided by Spain.

Romania and the Netherlands (16-20 million inhabitants): Romania reports 1 496

inspections per year; the Netherlands notes that between 2012 and 2013 135

manufacturers and importers of toys were inspected and that some of the companies

were trading in different product groups.

Belgium, Greece, Czech Republic, Portugal, Hungary, Sweden, Austria and Bulgaria

(7-11 million inhabitants): Belgium reports 1 270

inspections per year on average;

Greece reports 28 inspections

, however the yearly activity went down over the period

from 38 to 8 inspections; the Czech Republic reports 1 631 inspections; Portugal reports

235 inspections with a big increase in 2012 and 2013 (respectively 453 and 405

inspections) by comparison with 2010 and 2011 (50 and 30 inspections each); Hungary

Also includes those concerning non-harmonised consumer goods.

According to the common template prepared by the Commission, inspections are regular or ad hoc visits, controls (including checks

on the internet) or other forms of contacts (mail, telephone) undertaken by an inspector, with an enforcement focus (excluding pure

information-exchange) and aimed at verification of product safety and compliance. Where several products/models/regulations are

checked during the same exercise, this should be counted as one inspection. In order to be considered an inspection, there must be

an official report prepared following the action.

The number of inhabitants is taken here as a very simple (although admittedly very rough) estimate of national market sizes.

The figure does not include checks carried out by customs that in France are market surveillance authorities.

For 2010 and 2011 Belgium reports respectively 110 and 639 investigations to which the follow-up to Rapex notifications

concerning toys should be added. The inclusion of toys Rapex notifications for years 2012 and 2013 brings the number of

inspections respectively up to 2251 and 2078.

The Greek report notes these were carried out "at virtually zero cost".

488

reports 1 180 inspections; Sweden reports 84 inspections; Austria reports 584

inspections with a big increase in 2012 and 2013 (respectively 117 and 130 inspections)

by comparison with 2010 and 2011 (52 and 37 inspections each); Bulgaria reports 1 739

inspections.

Denmark, Finland, Slovakia, Ireland and Croatia (4-6 million inhabitants): Denmark

reports 113 average inspections per year, with a drop in the number of inspections

carried out in 2012 and 2013 (90 per year) compared to those carried out in 2010 and

2011 (respectively 138 and 133); Finland reports 1 351 inspections with big drop in

2013 (808 inspection) compared to the previous year (1 739 inspections); Ireland

reports 4 inspections

; Croatia reports 384 inspections for the last semester of 2013.

Lithuania, Slovenia and Latvia (2-3 million inhabitants): no information is available for

Lithuania; Slovenia reports 1 757 average inspections per year (including those in

kindergartens); Latvia reports 116 inspections.

Estonia (1.3 million inhabitants) reports 402 average inspections per year

Cyprus, Malta and Luxembourg (less than a million inhabitants): Cyprus reports 960

average inspections per year, with a peak of activity in 2010 (1 257 inspections)

compared to the other years; Malta reports 149 inspections; Luxembourg reports 51

inspections including visual inspections of labelling.

The figures reported in this section should be interpreted carefully as it cannot be excluded

that the figures collected by different Member States do not entirely correspond. For instance

it is likely that certain checks at the border

are included by some Member States and

excluded by others depending on the way responsibilities are shared.

The overview above reports the figures provided by the Member States. It does not constitute

an assessment of the amount of effort made by market surveillance authorities and whether

enforcement activities carried out were to an appropriate scale. Assessing the scale of the

checks would presuppose among others information about the number and type of economic

operators making products available in a given country, as well as the number of products

involved in a given inspection (e.g. an inspection addressing the principal or exclusive

national importer of a product made available throughout the whole national market is

expected to involve a larger number of products than inspections carried out in a single retail

outlet).

4.3

On the nature of inspections

Proactive vs reactive inspections:

When looking at the share of proactive (including

inspections prompted by customs) versus reactive inspections, it appears that about 60 % of

the inspections reported by Member States

for the period 2010-2013 were proactive

inspections. However the situation changes from country to country (see Table 7-3 below). At

the high end of the spectrum are France, Romania, Luxembourg and Latvia whose reported

inspections are virtually entirely self-initiated, followed by Poland and Greece (83%),

Not limited to toys.

For instance sample checks, if any, conducted by customs without prior coordination with market surveillance authority and which

did not give rise to subsequent in-depth investigations.

This average is based on data provided by 17 Member States. In particular it excludes Germany, Spain, Lithuania and the

Netherlands for which no information on investigations in the toys sectors is provided. It also excludes Estonia, Italy, Czech

Republic, Cyprus, Austria, Finland and the UK whose data are incomplete or contained inconsistencies so that the share of self-

initiated investigations could not be calculated.

489

Slovenia (77%), Bulgaria, Hungary, Croatia and Sweden (65-60%), Denmark, Malta and

Portugal (55-50%) and then Slovakia (38%). At the low end of the spectrum are Belgium

(12%)

–

recorded a high number of reactions to Rapex notifications

–

and Ireland (0%).

Table 7-3: Share of self-initiated inspections out of total inspections (percentages)

n.a.

As regards Belgium the share is calculated on the figures provided for 2013 only.

490

n.a.

Types of checks:

The share of physical and laboratory checks as opposed to merely

administrative checks is about 100% for Bulgaria, Denmark, Cyprus, Latvia and Slovakia,

close to 90% for Czech Republic, around 75-80% for Luxembourg and Slovenia, and 57-58%

for Finland and Sweden. Lower shares are given for Portugal (27%) and Croatia (18%).

Unfortunately the relevant share cannot be calculated for some countries due to different

interpretations of the information requested. It appears nevertheless that a very high total

number of physical and laboratory tests were carried out by France, the UK, Hungary and

Poland.

In most cases the share of laboratory tests cannot be singled out due to the different

approaches used in collecting the data.

4.4

On the share of inspections prompted by customs

The average share of inspections prompted by customs is about 20%

, but varies between a

country such as Ireland, where all inspections concerning toys in the 2010-2013 period were

initiated by customs, and countries such as Greece, Romania, Slovenia, Portugal, Malta,

Hungary and Slovakia where virtually none or only 1% of the inspections were prompted by

border control authorities. The share is 7-11% for the UK, Sweden and Denmark, 19-20% for

Poland, Latvia and Cyprus, 25-26% for Luxembourg and Bulgaria, 38% for Croatia, 54% for

Finland.

Table 7-4: Share of inspections prompted by customs (percentages)

n.a.

100

n.a.

This average is based on data provided by 18 Member States. Notably, it excludes Germany, Spain, Lithuania and the Netherlands,

for which no information on investigations in the toys sectors is provided. It also excludes Estonia, Italy, Czech Republic, Cyprus

and Austria whose data are incomplete or contained inconsistencies so that the share of self-initiated investigations could not be

calculated. It excludes France where customs are market surveillance authorities and carry out checks for themselves.

491

n.a.

The relatively low involvement of customs in some countries appears at odds with the fact

that many of the toys on national markets are imported from third countries. This might be

explained by possible cooperation issues between customs and market surveillance

authorities. It might possibly also be due to the fact that, traditionally being used to a different

'core business', customs may not feel fully committed to the more recent goal of product

safety and compliance. As a matter of fact countries like France and Finland, where customs

are directly involved in market surveillance, the percentage of inspections prompted by them

is remarkably higher.

4.5

On the outcomes of inspections: Finding of non-compliance

The share of inspections reported by Member States giving rise to a finding of non-

compliance was on average 44% in the EU

. Again however there are significant differences

between Member States: the share is 83% for Sweden, 81% for Romania, 73% for Malta,

54% for Poland, 45% for Latvia and Greece, 39-40% for Slovakia and Bulgaria, 32-34% for

This is the simple average of national percentages based on data provided by 16 Member States, while the weighted average is

32%. Those averages exclude Germany, Spain, Lithuania and the Netherlands for which no information on investigations in the

toys sectors is provided. They also excludes Belgium, Estonia, Italy, Czech Republic, Cyprus, Austria, Finland and the UK whose

data are incomplete or contained inconsistencies so that the share of self-initiated investigations could not be calculated.

492

Hungary and Luxembourg, 26% for Denmark, 12-15% for Portugal, France, Croatia and

Slovenia.

The level of non-compliance rates found by toys market surveillance authorities on the one

hand represents an indication of the existence of non-compliance in the sector, while on the

other hand it says something about the authorities' ability to spot it. For instance, it is

assumed that the rate should be lower overall for proactive inspections involving random

sample checks (like, apparently, for France, Slovenia and Luxembourg), while it should be

higher for targeted proactive inspections and reactive inspections pursuant to concrete

indications (e.g. by complainants, Rapex notifications) that point to the non-compliance of

certain products. However, the quality, respectively, of the prioritisation work leading to

random sample checks and the screening/assessment of the complaints also has an impact on

the probability of spotting non-compliance.

4.5

On the outcomes of inspections: Measures and penalties

Follow up to inspections where non-compliance was found:

The comparison of the number of

inspections where non-compliance was found, with the sum of (voluntary or compulsory)

measures taken by market surveillance authorities and/or the total number of

sanctions/penalties applied, provides an indication of the follow-up given by market

surveillance authorities. On the basis of the data provided, it appears that on average the EU

authorities were able to provide a follow-up in two-thirds of cases at most.

Table 7-5 shows that, among Member States with percentages higher than the EU average,

Estonia and Hungary indicate the application of measures and/or sanctions for all inspections

reported for the 2010-2013 period; Latvia, Portugal and Luxembourg indicate a follow up

respectively for 86%, 75% and 71% of the inspections; Finland and Denmark for 68-69% of

inspections. Among Member States indicating percentages lower than the EU average, Malta

and Greece report 52%, Cyprus 46%, Czech Republic, Bulgaria and Sweden 36-37%, France

29%, Slovakia 14%.

Table 7-5: Follow up to inspections: percentage of cases of non-compliance where

measures and/or penalties were applied

n.a.

100

This average is based on data provided by 17 Member States. Notably, it excludes Germany, Spain, Lithuania and the Netherlands

for which no information on investigations in the toys sectors is provided. It also excludes the UK, Belgium, Poland, Slovenia,

Croatia, Italy and Austria whose data are incomplete or contained inconsistencies so that the share of self-initiated investigations

could not be calculated. The average probably overestimates the number of inspections with a follow-up, as in some case both

corrective action and sanctions were imposed in a given inspection, so the figures worked out by the Commission involve some

double counting.

493

n.a.

100

n.a.

Corrective action vs sanctions:

On average corrective action was taken in the EU for 50% of

the inspections that found non-compliance, while sanctions were applied for about 20% of

those inspections. It appears that countries like Sweden, Finland, Malta, Luxembourg,

Cyprus, Estonia and Denmark have given a net preference to corrective measures, others like

Czech Republic, Portugal, and Slovakia have mainly applied sanctions/penalties, while the

remaining have used an evenly-balanced mix of both.

Voluntary vs compulsory corrective action:

The respective roles of voluntary and compulsory

corrective action can be estimated only for eleven Member States and shows that Estonia,

Greece, Cyprus, Latvia, Luxembourg, Croatia, Hungary and Finland resorted to a large extent

to compulsory measures while Bulgaria, Sweden and, to a lesser extent, Denmark resorted

mostly to voluntary measures.

494

The fact that corrective action and/or sanctions are reported only for a subset of inspections

where non-compliance is found raises the question of what happens for the remaining

inspections that have spotted non-compliance: is this due to lack of traceability/identification

of the economic operators, or difficulties to reach him/her abroad, or the fact that the product

is no longer on the market. One Member State observed that a small proportion of producers

are based in the national territory and that the possibility of imposing measures in relation to

the responsibilities of distributors is rather limited. On the other hand the fact that many

market surveillance authorities focus their inspections on distributors and importers is

expected to influence only the type and not the number of follow-ups provided.

It also appears that sanctions do not systematically accompany the imposition of compulsory

corrective action.

4.6

On cross-border cooperation

Among the twelve Member States providing information on this point, only the Czech

Republic and Denmark reported cases of inspections - 18 and 1 respectively - in which other

Member States were invited to collaborate during the 2010-2013 period.

The indicator suggests that cross-border cooperation is extremely low. This is particularly

problematic in a sector like toys where products are very often imported from third countries

and from other EU countries.

4.7

On budget and staff

Only 10 Member States indicated budget

and/or staff available for market surveillance

activities in the toys area between 2010 and 2013. These were on average as follows:

Bulgaria: 640

320 €, 75 overall staff dedicated to market surveillance of

both toys and

the other 'new Approach' products, of which 30 inspectors;

Denmark: 233

300 €, 2 overall staff of which 1 inspector;

France: 1 560

000 € excluding budget for testing products, 23 overall staff of which 20

inspectors;

Hungary: 441

579 €, 33 overall

staff of which 21 inspectors;

Finland: 780

000 €, 13 overall staff of which 12 inspectors;

Sweden: 178

641 €, 2.5 overall staff of which 0.5 inspectors;

Greece: 13 overall staff of which 10 inspectors;

While the budget of Bulgaria and Finland remained stable overall between 2010 and 2013, the

budgets of Denmark and France were reduced and those of Hungary and Sweden increased.

According to the indication contained in the common template, the budget figure should cover all financial resources which are

assigned by public authorities to market surveillance and enforcement activities as well as to projects and measures aimed at

ensuring compliance of economic operators with product legislation. These measures range from communication activities

(consumer/business information and education) to pure enforcement and market surveillance activities. They include the

remuneration of staff, direct costs of inspections, laboratory tests, training and office equipment costs. Enforcement activities at

regional/local level should also be reported. Other activities undertaken by these authorities not related to the enforcement of

product legislation laws should be excluded from the calculation.

495

In addition Ireland and Slovenia report the figures of 5.875.000 € and 5.633.460 €

respectively, which amount to the total budget of the authorities responsible, amongst others,

for toys market surveillance. Ireland indicates that 7 authorised officers work in the product

safety unit and that additional officers are available to assist if required. Slovenia reports that

the total number of the authority's employees is 133, while the total number of inspectors is

110. They are engaged in the official control of all areas of Inspectorates' field of operation.

There is no specialisation by area.

It is surprising that only a few Member States could quantify the resources available for

market surveillance of toys. Information on the availability of information on resources

appears important to identify major resource gaps to be addressed.

In relation to data provided, it is not clear if all the figures consistently include the

remuneration of staff and other possible common costs (overheads), in addition to specific

market surveillance costs (e.g. sampling and testing costs).

4.8

On the assessment provided by Member States

Most Member States completed the information reported in the previous sections with useful

additional descriptions of the activities carried out, the type of non-compliances found or the

working methods used. Many consider that enforcement and information actions must be

continued. Lack of knowledge about legal requirements applicable to toys and economic

operators' responsibilities are very often reported.

Only a few Member States (notably Cyprus and Sweden, as well as in a much less detailed

manner Bulgaria, Austria, Slovakia) were able to report information on the number and type

of economic operators, value of market, value and import flows, which as noted in the section

on the number of inspections, appears as an important piece of information to assess the scale

of market surveillance checks. Not surprisingly, therefore, no Member State conducted an

explicit assessment of market surveillance along those lines. Nevertheless Bulgaria mentions

that a consistent and comprehensive monitoring of the market took place. On the other hand,

Finland comments on the efficiency of enforcement efforts which lead to a certain number of

products recalls and withdrawals despite relatively small resources. Among the challenges

faced, toys market surveillance authorities mention 'Asian marketplaces' and fairs selling

cheap toys where low rates of non-compliance are found and where products found to be

unsafe are often put back on the market, sometimes after rebranding. Also, Denmark mentions

the need to clarify the legal position of agents, and the responsibility of distributors when a

manufacturer declares bankruptcy.

VERAGE

EU S

TATISTICS PER SECTOR

ERIVED

ROM

2010-2013 R

EVIEW

SSESSMENT

EPORTS

The statistics in the next pages are calculated on the basis of data made available by Member

States. Statistics should be interpreted with due care due to fact that some inconsistencies in

the interpretation of the different definitions given by some respondents. It is also noted that

not all Member States provided information on all items. For instance the following table

shows the number of Member States reported concrete information on inspections carried out

in a given sector.

496

Table 7-6: Member States reporting data on the number of inspections per sector

Sector

Medical devices

Cosmetics

Personal protective equipment

Construction products

Aerosol dispensers

Simple pressure vessels and pressure equipment

Transportable pressure equipment

Machinery

Lifts

Cableways

Noise emissions for outdoor equipment

Equipment and protective systems intended for use in

potentially explosive atmospheres

Pyrotechnics

Explosives for civil uses

Appliances burning gaseous fuels

Measuring instruments, non-automatic weighting instruments

and pre-packed products

Electrical equipment under EMC

Electrical appliances and equipment under LVD

Electrical and electronic equipment under ROHS, WEEE and

batteries

Chemicals

No of MS reporting data

497

Sector

Eco-design & energy efficiency

Recreational craft

Marine equipment

Motor vehicles and tyres

Non-road mobile machinery

Fertilisers

Other consumer products under GPSD (optional)

Biocides

Textile & footwear labelling

Crystal glass

Source: National reports

No of MS reporting data

498

Table 7-7: Statistics on inspections carried out in the 2010-2013 period by all national authorities having provided data

Information below is only indicative information as data are not always fully comparable.

SECTOR 1 - Medical

devices (including in

vitro diagnostic medical

devices and active

implantable medical

devices)

Member

State

Population

(million)

11.29

7.20

10.54

5.66

81.20

1.31

4.63

10.81

46.44

66.99

4.23

1589.50

23.73

2,833.75

768.00

42.30

181.76

594.00

8.87

923.75

13.79

111.00

47.50

84.52

10.27

485.50

104.25

369.69

22.54

401.50

4.33

28.25

305.73

0.94

2.61

360.75

29.00

24.25

274.70

6.27

2.24

80.75

7.47

24.50

18.66

121.00

167.00

16.50

16.80

15.85

2.92

1215.25

91.00

115.32

16.08

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 2 - Cosmetics

SECTOR 3 - Toys

SECTOR 4 - Personal

Protective Equipment

SECTOR 5 -

Construction Products

Number of

inspections

Inspections

per 100000

inhabitants

Number of

inspections

1,269.50

1,738.75

1,631.25

113.00

Inspections

per 100000

inhabitants

112.49

241.42

154.79

19.97

Number of

inspections

Inspections

per 100000

inhabitants

Number of

inspections

Inspections

per 100000

inhabitants

610.25

395.75

32.25

84.73

37.55

5.70

805.50

349.00

51.67

111.84

33.12

9.13

499

SECTOR 1 - Medical

devices (including in

vitro diagnostic medical

devices and active

implantable medical

devices)

Member

State

Population

(million)

60.80

0.85

1.99

2.92

0.56

9.85

0.43

16.90

8.58

38.01

10.37

19.86

14.25

33.00

2913.75

1.66

0.87

280.85

39.50

111.00

4.01

258.53

Number of

inspections

125.00

20.75

25.75

Inspections

per 100000

inhabitants

2.06

24.50

12.97

SECTOR 2 - Cosmetics

SECTOR 3 - Toys

SECTOR 4 - Personal

Protective Equipment

SECTOR 5 -

Construction Products

Number of

inspections

1385.25

Inspections

per 100000

inhabitants

22.79

Number of

inspections

Inspections

per 100000

inhabitants

Number of

inspections

35.25

Inspections

per 100000

inhabitants

0.58

24.50

39.27

Number of

inspections

Inspections

per 100000

inhabitants

959.50

412

207.44

116.00

1132.81

58.41

20.75

78.00

105.25

52.99

51.00

12351.75

83.75

1254.11

195.07

1,180.25

149.25

90.59

119.83

347.62

181.75

57.50

18.45

133.93

509

51.68

1946.75

203.75

1293.5

226.76

5.36

124.68

583.50

754.00

234.50

1,495.75

67.97

19.84

22.60

75.31

52.25

562.75

52.50

294.75

6.09

14.81

5.06

14.84

1573.25

75.5

1595.5

6.64

41.40

7.28

80.33

500

SECTOR 1 - Medical

devices (including in

vitro diagnostic medical

devices and active

implantable medical

devices)

Member

State

Population

(million)

2.06

5.42

5.47

9.75

64.88

Number of

inspections

16.50

2.25

13.25

30.25

Inspections

per 100000

inhabitants

8.00

0.42

2.42

3.10

SECTOR 2 - Cosmetics

SECTOR 3 - Toys

SECTOR 4 - Personal

Protective Equipment

SECTOR 5 -

Construction Products

Number of

inspections

1921.5

10472.5

382.25

125

1327.50

Inspections

per 100000

inhabitants

931.47

1931.71

69.86

12.82

20.46

Number of

inspections

1,756.50

1,517.00

1,351.25

84.00

1,482.00

Inspections

per 100000

inhabitants

851.48

279.82

246.95

8.62

22.84

Number of

inspections

157.00

382.75

182.75

71.50

Inspections

per 100000

inhabitants

76.11

70.60

33.40

7.34

Number of

inspections

322.75

579.75

322.5

59.75

Inspections

per 100000

inhabitants

156.46

106.94

58.94

6.13

Figures include also all beauty care services inspections.

Figures include also inspections in kindergartens.

501

SECTOR 6 - Aerosol

dispensers

Inspections

per 100000

inhabitants

SECTOR 7 - Simple

pressure vessels and

Pressure Equipment

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 8 -

Transportable pressure

equipment

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 9 - Machinery

SECTOR 10 - Lifts

Member

State

Population

(million)

11.29

7.20

10.54

5.66

81.20

1.31

4.63

10.81

46.44

66.99

4.23

60.80

0.85

1.99

Number of

inspections

Number of

inspections

93.25

Inspections

per 100000

inhabitants

8.26

132.04

41.18

26.90

Number of

inspections

6.75

184.67

31.00

0.25

Inspections

per 100000

inhabitants

0.60

25.64

2.94

0.04

236.50

1759.00

0.50

32.84

166.92

0.09

650.25

118.25

29.25

90.28

11.22

5.17

168.25

10.50

1.50

23.36

1.00

0.27

951.00

434.00

152.25

3.75

1.00

9.50

0.88

7.00

2.86

0.22

0.65

2.50

0.23

75.75

52.25

41.75

57.68

11.30

3.86

57.00

2.00

12.32

0.18

3,300.00

49.26

2.00

0.03

1,027.25

15.33

102.75

65.75

77.63

191.50

8.00

226.09

4.03

17.75

66.75

20.96

33.61

70.75

21.75

1.69

83.53

10.95

43.75

0.25

51.65

0.13

502

SECTOR 6 - Aerosol

dispensers

Inspections

per 100000

inhabitants

SECTOR 7 - Simple

pressure vessels and

Pressure Equipment

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 8 -

Transportable pressure

equipment

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 9 - Machinery

SECTOR 10 - Lifts

Member

State

Population

(million)

2.92

0.56

9.85

0.43

16.90

8.58

38.01

10.37

19.86

2.06

5.42

5.47

9.75

64.88

Number of

inspections

Number of

inspections

Inspections

per 100000

inhabitants

Number of

inspections

Inspections

per 100000

inhabitants

26.75

97.25

226.51

97.25

2.72

226.51

128.25

13.02

569.50

17.00

57.82

39.60

97.00

104.00

9.85

242.23

3.50

0.75

20.50

60.00

4.00

0.41

0.02

1.98

3.02

1.94

3.50

125.00

74.25

81.25

241.25

0.41

3.29

7.16

4.09

116.95

3.50

230.75

0.41

6.07

51.50

884.00

51.50

6.00

23.26

4.96

28.12

86.41

12.50

2.25

1.46

0.06

7.25

98.00

0.37

47.51

558.50

178.25

7.00

44.75

0.35

21.69

1.00

0.18

0.10

22.00

3.75

4.02

0.38

3.00

0.31

248.25

1,903.50

45.37

195.28

0.25

1.00

0.05

0.10

503

SECTOR 11 - Cableways

SECTOR 12 - Noise

emissions for outdoor

equipment

SECTOR 13 -

Equipment and

Protective Systems

Intended for use in

Potentially Explosive

Atmospheres

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 14 -

Pyrotechnics

SECTOR 15 - Explosives

for civil uses

Member

State

Population

(million)

11.29

7.20

10.54

5.66

81.20

1.31

4.63

10.81

46.44

66.99

4.23

60.80

0.85

Number of

inspections

Inspections

per 100000

inhabitants

Number of

inspections

68.33

Inspections

per 100000

inhabitants

6.06

25.46

11.36

0.35

Number of

inspections

Inspections

per 100000

inhabitants

Number of

inspections

Inspections

per 100000

inhabitants

1.33

6.75

0.19

0.64

183.33

119.75

2.00

5.00

33.50

5.00

0.69

3.18

0.88

742.25

235.50

71.50

103.06

22.35

12.63

26.50

3.50

3.68

0.33

33.25

2.00

0.43

443.50

7.50

25.32

95.87

0.69

14.00

443.50

1.00

10.66

95.87

0.09

45.50

0.68

22.50

0.34

85.25

2.00

1.27

0.47

0.27

38.67

10.00

0.15

134.67

2.22

0.25

0.30

16.25

32.75

13.25

55.50

0.22

65.52

504

SECTOR 11 - Cableways

SECTOR 12 - Noise

emissions for outdoor

equipment

SECTOR 13 -

Equipment and

Protective Systems

Intended for use in

Potentially Explosive

Atmospheres

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 14 -

Pyrotechnics

SECTOR 15 - Explosives

for civil uses

Member

State

Population

(million)

1.99

2.92

0.56

9.85

0.43

16.90

8.58

38.01

10.37

19.86

2.06

5.42

5.47

Number of

inspections

0.25

Inspections

per 100000

inhabitants

0.13

Number of

inspections

21.75

Inspections

per 100000

inhabitants

10.95

Number of

inspections

380.25

Inspections

per 100000

inhabitants

191.46

Number of

inspections

380.25

Inspections

per 100000

inhabitants

191.46

49.25

5.00

10.00

1.02

1.50

3.49

84.75

8.60

6,080.00

5.50

4.50

0.25

117.50

16.75

708.22

0.14

0.43

0.01

56.96

3.09

16.25

2.97

82.00

14.99

386.75

37.25

307.25

69.50

10.18

3.59

15.47

33.69

21.00

1.06

39.50

1.04

1225.50

110.50

3747.75

58.00

27.00

244.75

36.25

142.75

2.91

361.24

2.92

13.09

45.15

6.62

4.00

5935.50

15.50

1.25

87.25

2.00

0.11

572.11

0.78

0.61

16.09

0.37

505

SECTOR 11 - Cableways

SECTOR 12 - Noise

emissions for outdoor

equipment

SECTOR 13 -

Equipment and

Protective Systems

Intended for use in

Potentially Explosive

Atmospheres

Number of

inspections

1.50

Inspections

per 100000

inhabitants

0.15

SECTOR 14 -

Pyrotechnics

SECTOR 15 - Explosives

for civil uses

Member

State

Population

(million)

9.75

64.88

Number of

inspections

Inspections

per 100000

inhabitants

Number of

inspections

8.00

Inspections

per 100000

inhabitants

0.82

Number of

inspections

3.50

Inspections

per 100000

inhabitants

0.36

Number of

inspections

Inspections

per 100000

inhabitants

506

SECTOR 16 - Appliances

burning gaseous fuels

SECTOR 17 - Measuring

instruments, Non-

automatic weighing

instruments (NAWI) and

Pre-packaged products

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 18 - Electrical

equipment under EMC

SECTOR 19 - Radio and

telecom equipment under

RTTE

SECTOR 20 - Electrical

appliances and

equipment under LVD

Member

State

Population

(million)

11.29

7.20

10.54

5.66

81.20

1.31

4.63

10.81

46.44

66.99

4.23

60.80

0.85

Number of

inspections

22.00

466.75

58.50

30.75

Inspections

per 100000

inhabitants

1.95

64.81

5.55

5.43

Number of

inspections

Inspections

per 100000

inhabitants

Number of

inspections

578.00

Inspections

per 100000

inhabitants

51.22

33.64

22.87

19.88

0.08

1420.69

Number of

inspections

788.50

1774.75

1306.50

456.00

Inspections

per 100000

inhabitants

69.87

246.42

123.98

80.57

1339.75

491.50

115.25

186.02

46.64

20.36

831.33

840.00

112.50

6.53

115.43

79.71

19.88

0.08

141.25

242.25

241.00

112.50

6.53

1,865.75

21.25

16.18

6.75

14149.50

12872.50

5.14

3058.77

1190.52

185.50

193.00

4.33

146.96

0.94

9.60

4.50

0.42

136.50

12.62

103.75

10.00

0.15

897.00

1106.00

103.75

13.39

261.76

1.71

525.00

7.84

745.50

18.00

350.75

11.13

4.26

5.77

18.89

2076.50

31.00

104.25

121.25

1.71

143.15

9.33

11.02

117.75

139.02

16.00

507

SECTOR 16 - Appliances

burning gaseous fuels

SECTOR 17 - Measuring

instruments, Non-

automatic weighing

instruments (NAWI) and

Pre-packaged products

Number of

inspections

25.25

Inspections

per 100000

inhabitants

12.71

SECTOR 18 - Electrical

equipment under EMC

SECTOR 19 - Radio and

telecom equipment under

RTTE

SECTOR 20 - Electrical

appliances and

equipment under LVD

Member

State

Population

(million)

1.99

2.92

0.56

9.85

0.43

16.90

8.58

38.01

10.37

19.86

2.06

5.42

5.47

Number of

inspections

8.75

Inspections

per 100000

inhabitants

4.41

Number of

inspections

141.00

Inspections

per 100000

inhabitants

70.99

Number of

inspections

9.00

Inspections

per 100000

inhabitants

4.53

Number of

inspections

461.00

Inspections

per 100000

inhabitants

232.11

51.25

23.00

6.00

91.04

2.34

13.97

717.50

214.25

1274.52

21.75

441.00

104.75

24.00

783.36

10.64

55.90

8.88

6.46

14.75

1.54

19.67

4.24

190.50

170.00

24.00

150

276.25

285.25

321.75

765.00

180.25

338.39

17.26

55.90

8.88

32.18

7.51

31.01

38.52

87.38

275.75

2065.25

163.25

489.82

209.69

380.23

8 NAWI

examined

4699.75

28.75

26.00

101.50

41.00

34.00

3.75

0.76

2.51

5.11

19.88

6.27

0.69

206.00

20.75

221.25

1723.25

0.47

547.44

0.55

21.33

86.76

150

55.50

560.50

16.00

390.75

8.75

55.50

1105.50

149.25

1092.50

312.50

1318.25

6.46

29.09

14.39

55.01

151.49

243.16

371.22

38.00

272.25

49.76

164.75

30.11

2031.25

508

SECTOR 16 - Appliances

burning gaseous fuels

SECTOR 17 - Measuring

instruments, Non-

automatic weighing

instruments (NAWI) and

Pre-packaged products

Number of

inspections

3.67

Inspections

per 100000

inhabitants

0.38

SECTOR 18 - Electrical

equipment under EMC

SECTOR 19 - Radio and

telecom equipment under

RTTE

SECTOR 20 - Electrical

appliances and

equipment under LVD

Member

State

Population

(million)

9.75

64.88

Number of

inspections

6.50

Inspections

per 100000

inhabitants

0.67

Number of

inspections

54.25

Inspections

per 100000

inhabitants

5.57

Number of

inspections

44.25

Inspections

per 100000

inhabitants

4.54

Number of

inspections

373.75

Inspections

per 100000

inhabitants

38.34

509

SECTOR 21 - Electrical

and electronic equipment

under RoHS, WEEE and

batteries

Member

State

Population

(million)

11.29

7.20

10.54

5.66

81.20

1.31

4.63

10.81

46.44

66.99

4.23

60.80

0.85

1.99

141.00

70.99

193.00

38.75

130.00

146.96

8.38

12.02

Number of

inspections

18.00

252.75

57.00

16.50

Inspections

per 100000

inhabitants

1.59

35.09

5.41

2.92

SECTOR 22 - Chemicals

(Detergents, Paints,

Persistent organic

pollutants)

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 23 - Ecodesign

and Energy labelling

SECTOR 24 - Efficiency

requirements for hot-

boilers fired with liquid

or gaseous fuels

Number of

inspections

3.25

Inspections

per 100000

inhabitants

0.29

SECTOR 25 -

Recreational craft

Number of

inspections

57.25

Inspections

per 100000

inhabitants

5.07

99.62

13.88

34.37

Number of

inspections

Inspections

per 100000

inhabitants

589.25

17.25

50.25

81.82

1.64

8.88

717.50

146.25

194.50

24.00

10.00

0.95

146.00

0.25

3.33

13.85

0.04

673.75

85.50

395.00

513.03

18.48

36.53

103.75

9.60

16.25

4.67

3.51

0.43

3.50

0.32

711.00

10.61

262.25

3.91

51.50

0.77

26.00

215.75

402.00

202.41

141.00

0.43

254.72

70.99

3.25

1.64

510

SECTOR 21 - Electrical

and electronic equipment

under RoHS, WEEE and

batteries

Member

State

Population

(million)

2.92

0.56

9.85

0.43

16.90

8.58

38.01

10.37

19.86

2.06

5.42

5.47

9.75

64.88

326.50

190.25

59.67

19.52

134.00

120.75

473.75

276.75

3.53

11.64

23.85

134.16

24.00

163.25

2.44

380.23

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 22 - Chemicals

(Detergents, Paints,

Persistent organic

pollutants)

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 23 - Ecodesign

and Energy labelling

SECTOR 24 - Efficiency

requirements for hot-

boilers fired with liquid

or gaseous fuels

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 25 -

Recreational craft

Number of

inspections

Inspections

per 100000

inhabitants

Number of

inspections

Inspections

per 100000

inhabitants

19.50

3693.50

95.00

375.01

221.27

45.25

32.00

34.64

4.59

74.53

6.75

0.69

11.75

27.37

64.25

128.75

7.48

3.39

56.67

254.25

6.60

6.69

3.25

52.50

0.38

1.38

136.50

44.25

103.50

7.75

23.50

21.45

19.09

1.42

2.41

60.75

120.75

616.50

94.75

6.87

29.45

22.27

112.67

9.72

3.75

0.19

22.00

22.50

14.00

96.25

6.00

1.11

10.91

2.58

17.59

0.62

511

SECTOR 26 - Marine

Equipment

Inspections

per 100000

inhabitants

SECTOR 27 - Motor

vehicles and tyres

Inspections

per 100000

inhabitants

22.71

78.62

SECTOR 28 - Non-road

mobile machinery

Inspections

per 100000

inhabitants

SECTOR 29 - Fertilisers

SECTOR 30 - Other

consumer products under

GPSD

Number of

inspections

Inspections

per 100000

inhabitants

Member

State

Population

(million)

11.29

7.20

10.54

5.66

81.20

1.31

4.63

10.81

46.44

66.99

4.23

60.80

0.85

1.99

Number of

inspections

Number of

inspections

256.25

566.25

Number of

inspections

Number of

inspections

Inspections

per 100000

inhabitants

68.00

9.44

497.75

205.25

69.11

19.48

44.17

7,643.50

146.00

1061.27

13.85

1689.25

298.47

250.00

66.50

50.64

216.25

116.50

164.67

25.18

774.75

2.33

0.50

272.00

4.06

74.50

220.00

1.11

52.07

1,485.00

22.17

1.25

0.02

22.00

21.50

25.97

10.83

63.50

31.97

232.5

117.06

23.25

0.38

66.50

33.48

512

SECTOR 21 - Electrical

and electronic equipment

under RoHS, WEEE and

batteries

Member

State

Population

(million)

2.92

0.56

9.85

0.43

16.90

8.58

38.01

10.37

19.86

2.06

5.42

5.47

9.75

64.88

1.25

0.13

16.00

13.50

9.00

0.42

1.30

0.45

0.25

0.58

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 22 - Chemicals

(Detergents, Paints,

Persistent organic

pollutants)

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 23 - Ecodesign

and Energy labelling

SECTOR 24 - Efficiency

requirements for hot-

boilers fired with liquid

or gaseous fuels

Number of

inspections

Inspections

per 100000

inhabitants

SECTOR 25 -

Recreational craft

Number of

inspections

Inspections

per 100000

inhabitants

Number of

inspections

Inspections

per 100000

inhabitants

40.25

15.50

25.00

1.57

58.23

2.50

0.25

210.75

0.25

2.50

21.40

0.58

0.15

1,964.00

103.25

2.25

934.00

28.00

0.50

362.75

249.50

0.22

47.03

13.57

0.09

66.30

25.60

6.00

0.62

140.00

42.00

7.05

20.36

41.25

1752.5

335.5

139.75

283.5

2.72

3.98

88.24

162.64

25.78

51.81

931.75

264.50

292.00

6.50

2,281.25

71.50

231.62

228.77

28.15

0.33

170.28

27.14

513

Table 7-8: Statistics on inspections based on tests performed in laboratories carried out in the 2010-2013 period by all national

authorities having provided data

Information below is only indicative information as data are not always fully comparable.

SECTOR 1 - Medical

devices (including in vitro

diagnostic medical devices

and active implantable

medical devices)

SECTOR 2 - Cosmetics

SECTOR 3 - Toys

SECTOR 4 - Personal

Protective Equipment

SECTOR 5 - Construction

Products

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

11.29

7.20

10.54

5.66

81.20

1.31

4.63

10.81

0.00

21.00

4.54

63.00

5.83

1.00

0.09

4.00

0.37

165.75

40.00

15.73

7.07

33.00

5.83

0.00

13.50

1.87

32.00

2.84

2.00

0.28

514

SECTOR 1 - Medical

devices (including in vitro

diagnostic medical devices

and active implantable

medical devices)

SECTOR 2 - Cosmetics

SECTOR 3 - Toys

SECTOR 4 - Personal

Protective Equipment

SECTOR 5 - Construction

Products

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

46.44

66.99

4.23

60.80

0.85

1.99

2.92

0.56

9.85

0.43

16.90

0.25

0.03

191.50

19.44

7.50

70.75

13.32

7.18

1.75

0.18

4.00

0.41

0.25

0.30

20.50

10.32

61.25

29.50

72.31

14.85

11.75

5.92

608.75

9.09

827.00

60.00

12.34

14.20

4.50

0.07

261.00

5.75

308.14

2.90

92.00

1.37

37.50

0.56

515

SECTOR 1 - Medical

devices (including in vitro

diagnostic medical devices

and active implantable

medical devices)

SECTOR 2 - Cosmetics

SECTOR 3 - Toys

SECTOR 4 - Personal

Protective Equipment

SECTOR 5 - Construction

Products

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

8.58

38.01

10.37

19.86

2.06

5.42

5.47

9.75

64.88

0.00

125.75

47.50

22.98

4.87

15.00

7.27

0.00

10.50

96.75

0.28

9.33

35.25

142.50

0.93

13.74

498.25

14.75

3.25

44.25

159.25

731.75

3.75

633.00

13.11

1.42

0.16

21.45

29.37

133.73

0.38

9.76

0.50

9.25

1.50

0.00

10.25

22.50

37.25

26.75

0.06

0.24

0.14

0.00

4.97

4.15

6.81

2.74

24.00

30.00

0.00

1.50

5.75

16.25

0.50

2.80

0.79

0.00

0.08

2.79

3.00

0.09

516

SECTOR 6 - Aerosol

dispensers

SECTOR 7 - Simple

pressure vessels and

Pressure Equipment

SECTOR 8 -

Transportable pressure

equipment

SECTOR 9 - Machinery

SECTOR 10 - Lifts

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

11.29

7.20

10.54

5.66

81.20

1.31

4.63

10.81

46.44

66.99

4.23

60.80

8.00

0.12

2.00

0.03

315.75

4.71

0.00

8.00

1.41

0.00

2.00

0.28

517

SECTOR 6 - Aerosol

dispensers

SECTOR 7 - Simple

pressure vessels and

Pressure Equipment

SECTOR 8 -

Transportable pressure

equipment

SECTOR 9 - Machinery

SECTOR 10 - Lifts

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

0.85

1.99

2.92

0.56

9.85

0.43

16.90

8.58

38.01

10.37

19.86

2.06

0.00

1.75

0.25

0.00

0.20

0.01

0.00

1.75

1.25

0.00

0.20

0.03

0.00

1.75

0.00

0.20

0.00

2.25

0.75

0.00

13.25

0.06

0.07

0.00

6.42

0.00

0.75

0.00

8.00

0.81

0.00

3.25

1.64

0.00

518

SECTOR 6 - Aerosol

dispensers

SECTOR 7 - Simple

pressure vessels and

Pressure Equipment

SECTOR 8 -

Transportable pressure

equipment

SECTOR 9 - Machinery

SECTOR 10 - Lifts

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

5.42

5.47

9.75

64.88

0.00

1.25

0.23

0.00

9.25

1.69

0.00

519

SECTOR 11 - Cableways

SECTOR 12 - Noise

emissions for outdoor

equipment

SECTOR 13 - Equipment

and Protective Systems

Intended for use in

Potentially Explosive

Atmospheres

SECTOR 14 -

Pyrotechnics

SECTOR 15 - Explosives

for civil uses

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

11.29

7.20

10.54

5.66

81.20

1.31

4.63

10.81

46.44

66.99

4.23

0.00

21.75

0.32

85.25

1.27

10.00

0.00

25.50

4.51

8.00

1.11

1.00

0.09

520

SECTOR 11 - Cableways

SECTOR 12 - Noise

emissions for outdoor

equipment

SECTOR 13 - Equipment

and Protective Systems

Intended for use in

Potentially Explosive

Atmospheres

SECTOR 14 -

Pyrotechnics

SECTOR 15 - Explosives

for civil uses

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

60.80

0.85

1.99

2.92

0.56

9.85

0.43

16.90

8.58

38.01

10.37

0.00

0.75

0.00

0.07

1.00

0.03

6.00

2.50

0.16

0.24

0.00

2.50

0.00

0.24

0.00

0.50

0.05

0.00

3.25

1.64

0.00

521

SECTOR 11 - Cableways

SECTOR 12 - Noise

emissions for outdoor

equipment

SECTOR 13 - Equipment

and Protective Systems

Intended for use in

Potentially Explosive

Atmospheres

SECTOR 14 -

Pyrotechnics

SECTOR 15 - Explosives

for civil uses

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

19.86

2.06

5.42

5.47

9.75

64.88

0.00

522

SECTOR 16 - Appliances

burning gaseous fuels

SECTOR 17 - Measuring

instruments, Non-

automatic weighing

instruments and Pre-

packaged products

SECTOR 18 - Electrical

equipment under EMC

SECTOR 19 - Radio and

telecom equipment under

RTTE

SECTOR 20 - Electrical

appliances and equipment

under LVD

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

11.29

7.20

10.54

5.66

81.20

1.31

4.63

10.81

46.44

66.99

4.23

10.00

0.15

78.75

1.18

48.75

0.73

181.50

2.71

316.25

4.72

1.25

0.27

0.00

6.50

0.60

7.50

0.69

18.00

3.18

0.00

1.11

0.00

0.01

0.00

1.11

0.00

0.01

59.50

10.51

16.50

8.00

1.46

1.11

0.00

29.00

5.00

2.57

0.69

0.00

137.75

15.00

12.21

2.08

523

SECTOR 16 - Appliances

burning gaseous fuels

SECTOR 17 - Measuring

instruments, Non-

automatic weighing

instruments and Pre-

packaged products

SECTOR 18 - Electrical

equipment under EMC

SECTOR 19 - Radio and

telecom equipment under

RTTE

SECTOR 20 - Electrical

appliances and equipment

under LVD

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

60.80

0.85

1.99

2.92

0.56

9.85

0.43

16.90

8.58

38.01

10.37

0.00

2,611.50

0.00

1.00

0.47

304.20

0.00

0.10

0.00

119.50

2.25

0.30

0.00

3.14

0.22

0.00

51.75

131.25

0.30

0.00

1.36

12.65

0.25

35.25

1.50

0.03

0.93

0.14

1.25

0.00

2.22

0.00

716.25

34.75

1,272.30

3.53

10.50

80.50

18.65

8.17

5.75

168.25

10.21

17.08

18.50

163.50

32.86

16.60

0.00

13.25

6.67

1.75

0.03

4.00

38.00

4.72

19.13

120.50

0.00

1.98

0.00

28.25

32.75

66.33

0.46

38.67

33.40

524

SECTOR 16 - Appliances

burning gaseous fuels

SECTOR 17 - Measuring

instruments, Non-

automatic weighing

instruments and Pre-

packaged products

SECTOR 18 - Electrical

equipment under EMC

SECTOR 19 - Radio and

telecom equipment under

RTTE

SECTOR 20 - Electrical

appliances and equipment

under LVD

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

19.86

2.06

5.42

5.47

9.75

64.88

5.00

9.50

2.25

6.00

2.42

1.75

0.41

0.62

2,551.75

4.25

0.00

128.48

2.06

0.00

66.50

12.15

18.00

43.25

3.29

4.44

728.50

133.14

5.33

8.75

0.27

4.24

1.33

8.75

0.07

4.24

0.00

46.50

0.00

22.54

525

SECTOR 21 - Electrical

and electronic equipment

under RoHS, WEEE and

batteries

SECTOR 22 - Chemicals

(Detergents, Paints,

Persistent organic

pollutants)

SECTOR 23 - Ecodesign

and Energy labelling

SECTOR 24 - Efficiency

requirements for hot-

boilers fired with liquid or

gaseous fuels

SECTOR 25 -

Recreational craft

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

11.29

7.20

10.54

5.66

81.20

1.31

4.63

10.81

46.44

66.99

4.23

60.75

0.91

0.00

38.50

6.00

8.32

0.55

14.75

227.75

3.19

21.06

0.00

7.50

0.00

0.69

0.00

4.00

0.00

0.37

33.00

5.83

8.00

0.71

1.50

1.00

12.75

0.21

0.09

2.25

60.50

10.69

0.00

43.00

3.00

3.81

0.42

3.25

0.29

526

SECTOR 21 - Electrical

and electronic equipment

under RoHS, WEEE and

batteries

SECTOR 22 - Chemicals

(Detergents, Paints,

Persistent organic

pollutants)

SECTOR 23 - Ecodesign

and Energy labelling

SECTOR 24 - Efficiency

requirements for hot-

boilers fired with liquid or

gaseous fuels

SECTOR 25 -

Recreational craft

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

60.80

0.85

1.99

2.92

0.56

9.85

0.43

16.90

8.58

38.01

10.37

66.00

0.00

1.74

0.00

23.75

41.33

2.77

1.09

0.00

30.75

0.00

0.81

0.00

46.25

4.70

0.00

38.00

19.13

17.25

8.69

2.00

0.00

38.00

0.03

0.00

19.13

0.00

527

SECTOR 21 - Electrical

and electronic equipment

under RoHS, WEEE and

batteries

SECTOR 22 - Chemicals

(Detergents, Paints,

Persistent organic

pollutants)

SECTOR 23 - Ecodesign

and Energy labelling

SECTOR 24 - Efficiency

requirements for hot-

boilers fired with liquid or

gaseous fuels

SECTOR 25 -

Recreational craft

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

19.86

2.06

5.42

5.47

9.75

64.88

73.25

61.50

13.39

6.31

19.25

0.00

0.97

0.00

17.50

0.00

2.00

8.00

8.48

0.00

0.37

0.82

0.00

7.50

0.00

9.75

100.00

0.00

3.64

0.00

1.78

10.26

0.00

528

SECTOR 26 - Marine

Equipment

SECTOR 27 - Motor

vehicles and tyres

SECTOR 28 - Non-road

mobile machinery

SECTOR 29 - Fertilisers

SECTOR 30 - Other

consumer products under

GPSD

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

11.29

7.20

10.54

5.66

81.20

1.31

4.63

10.81

46.44

66.99

4.23

60.80

0.00

5.00

0.07

41.00

25.00

0.61

5.92

3.25

0.05

67.75

1.01

116.50

329.00

25.18

30.43

1.00

46.00

0.22

4.25

0.00

80.50

11.18

55.33

176.00

66.00

250.00

4,224.25

4.90

24.44

6.26

44.17

52.02

3.25

1,479.50

0.29

205.42

529

SECTOR 26 - Marine

Equipment

SECTOR 27 - Motor

vehicles and tyres

SECTOR 28 - Non-road

mobile machinery

SECTOR 29 - Fertilisers

SECTOR 30 - Other

consumer products under

GPSD

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

0.85

1.99

2.92

0.56

9.85

0.43

16.90

8.58

38.01

10.37

19.86

2.06

0.00

14.25

0.00

127.75

16.50

0.37

0.00

6.43

8.00

3.00

0.00

0.29

0.00

108.75

11.04

6.25

94.25

11.10

9.57

1.00

0.50

80.25

40.41

2.75

1.38

530

SECTOR 26 - Marine

Equipment

SECTOR 27 - Motor

vehicles and tyres

SECTOR 28 - Non-road

mobile machinery

SECTOR 29 - Fertilisers

SECTOR 30 - Other

consumer products under

GPSD

Member

State

Inspections

Number of

based on

inspections

tests

based on

Population

performed

tests

(million)

performed

laboratories

per 100000

laboratories

inhabitants

5.42

5.47

9.75

64.88

0.00

0.50

70.00

0.00

0.09

7.18

2.00

0.21

283.50

51.81

826.50

13.33

151.05

1.37

531

Table 7-9: Statistics on enforcement activities carried out in the 2010-2013 period by national authorities having provided data (averages

per Member State and per year)

Information below is only indicative information as data are not always fully comparable.

SECTOR 4 -

Personal

Protective

Equipment

209

142

SECTOR 5 -

Construction

Products

465

397

Information on enforcement activities carried out in

the 2010-2013 period

1. Number of product related accidents / user complaints

2. Number of substantiated complaints by industry

concerning unfair competition

3. Number of inspections (total number)

3.1 number of reactive inspections

3.2 number of self-initiated inspections

3.3 number of inspections prompted by the customs

4. Number of inspections based on:

4.1 tests performed in laboratories

4.2 physical checks of products

5. Number of inspections resulting in:

5.1 finding of non-compliance

5.2 corrective actions taken by economic operators

(“voluntary measures”)

5.3 restrictive measures taken by market surveillance

authorities

5.4 application of sanctions/penalties

6. Number of inspections where other Member States

were invited to collaborate

SECTOR 1 -

Medical devices

542

267

196

SECTOR 2 -

Cosmetics

2082

840

869

SECTOR 3 - Toys

891

425

487

211

1497

129

2378

191

1709

251

584

114

109

784

283

103

124

218

532

Information on enforcement activities carried out in

the 2010-2013 period

1. Number of product related accidents / user complaints

2. Number of substantiated complaints by industry

concerning unfair competition

3. Number of inspections (total number)

3.1 number of reactive inspections

3.2 number of self-initiated inspections

3.3 number of inspections prompted by the customs

4. Number of inspections based on:

4.1 tests performed in laboratories

4.2 physical checks of products

5. Number of inspections resulting in:

5.1 finding of non-compliance

5.2 corrective actions taken by economic operators

(“voluntary measures”)

5.3 restrictive measures taken by market surveillance

authorities

5.4 application of sanctions/penalties

6. Number of inspections where other Member States

were invited to collaborate

SECTOR 6 -

Aerosol dispensers

161

139

SECTOR 7 -

Simple pressure

vessels and

Pressure

Equipment

277

273

SECTOR 8 -

Transportable

pressure

equipment

SECTOR 9 -

Machinery

374

303

SECTOR 10 -

Lifts

147

144

186

434

105

169

533

Information on enforcement activities carried out in

the 2010-2013 period

SECTOR 11 -

Cableways

SECTOR 12 -

Noise emissions for

outdoor equipment

SECTOR 13 -

Equipment and

Protective Systems

Intended for use in

Potentially

Explosive

Atmospheres

SECTOR 14 -

Pyrotechnics

SECTOR 15 -

Explosives for civil

uses

1. Number of product related accidents / user complaints

2. Number of substantiated complaints by industry

concerning unfair competition

3. Number of inspections (total number)

3.1 number of reactive inspections

3.2 number of self-initiated inspections

3.3 number of inspections prompted by the customs

4. Number of inspections based on:

4.1 tests performed in laboratories

4.2 physical checks of products

5. Number of inspections resulting in:

5.1 finding of non-compliance

5.2 corrective actions taken by economic operators

(“voluntary measures”)

5.3 restrictive measures taken by market surveillance

authorities

5.4 application of sanctions/penalties

6. Number of inspections where other Member States

were invited to collaborate

483

108

375

343

442

346

268

100

157

224

212

426

258

534

Information on enforcement activities carried out in

the 2010-2013 period

SECTOR 16 -

Appliances

burning gaseous

fuels

SECTOR 17 -

Measuring

instruments, Non-

automatic

weighing

instruments and

Pre-packaged

products

1946

175

1303

SECTOR 18 -

Electrical

equipment under

EMC

SECTOR 19 -

Radio and telecom

equipment under

RTTE

SECTOR 20 -

Electrical

appliances and

equipment under

LVD

742

113

580

107

1. Number of product related accidents / user complaints

2. Number of substantiated complaints by industry

concerning unfair competition

3. Number of inspections (total number)

3.1 number of reactive inspections

3.2 number of self-initiated inspections

3.3 number of inspections prompted by the customs

4. Number of inspections based on:

4.1 tests performed in laboratories

4.2 physical checks of products

5. Number of inspections resulting in:

5.1 finding of non-compliance

5.2 corrective actions taken by economic operators

(“voluntary measures”)

5.3 restrictive measures taken by market surveillance

authorities

5.4 application of sanctions/penalties

6. Number of inspections where other Member States

were invited to collaborate

247

189

103

307

224

116

354

1410

213

253

104

743

110

144

213

255

535

Information on enforcement activities carried out in

the 2010-2013 period

SECTOR 21 -

Electrical and

electronic

equipment under

RoHS, WEEE and

batteries

160

138

SECTOR 22 -

Chemicals

(Detergents,

Paints, Persistent

organic pollutants)

443

392

SECTOR 23 -

Ecodesign and

Energy labelling

174

125

SECTOR 24 -

Efficiency

requirements for

hot-boilers fired

with liquid or

gaseous fuels

SECTOR 25 -

Recreational craft

1. Number of product related accidents / user complaints

2. Number of substantiated complaints by industry

concerning unfair competition

3. Number of inspections (total number)

3.1 number of reactive inspections

3.2 number of self-initiated inspections

3.3 number of inspections prompted by the customs

4. Number of inspections based on:

4.1 tests performed in laboratories

4.2 physical checks of products

5. Number of inspections resulting in:

5.1 finding of non-compliance

5.2 corrective actions taken by economic operators

(“voluntary measures”)

5.3 restrictive measures taken by market surveillance

authorities

5.4 application of sanctions/penalties

6. Number of inspections where other Member States

were invited to collaborate

249

107

512

823

127

101

536

Information on enforcement activities carried out in

the 2010-2013 period

1. Number of product related accidents / user complaints

2. Number of substantiated complaints by industry

concerning unfair competition

3. Number of inspections (total number)

3.1 number of reactive inspections

3.2 number of self-initiated inspections

3.3 number of inspections prompted by the customs

4. Number of inspections based on:

4.1 tests performed in laboratories

4.2 physical checks of products

5. Number of inspections resulting in:

5.1 finding of non-compliance

5.2 corrective actions taken by economic operators

(“voluntary measures”)

5.3 restrictive measures taken by market surveillance

authorities

5.4 application of sanctions/penalties

6. Number of inspections where other Member States

were invited to collaborate

SECTOR 26 -

Marine Equipment

SECTOR 27 -

Motor vehicles and

tyres

282

242

SECTOR 28 -

Non-road mobile

machinery

SECTOR 29 -

Fertilisers

260

232

SECTOR 30 -

Other consumer

products under

GPSD

382

248

179

210

370

488

449

155

123

537

Information on resources (subject to availability)

SECTOR 1 -

Medical devices

€ 1,391,889.47

29.43254%

42.54%

22.20%

96.12%

3.88%

6.98%

82.16%

SECTOR 2 -

Cosmetics

€ 4,993,717.97

1.36390%

256

37.68%

41.76%

4.55%

8.86%

2.69%

23.05%

SECTOR 3 - Toys

€ 1,917,787.47

1.52086%

31.77%

54.67%

34.12%

36.29%

43.75%

73.51%

SECTOR 4 -

Personal

Protective

Equipment

€ 270,913.43

0.01616%

37.56%

68.12%

54.10%

15.78%

32.37%

78.13%

SECTOR 5 -

Construction

Products

€ 425,273.22

0.80222%

46.91%

85.48%

40.22%

21.29%

15.22%

74.96%

7.1 Budget available to market surveillance authorities

in nominal terms

(€)

7.2 Budget available to market surveillance authorities

in relative terms (%age of total national budget)

8. Staff available to market surveillance authorities (full-

time equivalent units)

9. Number of inspectors available to market surveillance

authorities (full-time equivalent units)

Share of inspections resulting in finding of non-

compliance out of total inspections

Share of self-initiated inspections out of total

inspections

Share of corrective actions taken by economic

operators out of finding of non-compliance

Share of restrictive measures out of finding of non-

compliance

Share of application of sanctions / penalties out of

finding of non-compliance

Share of inspectors out of staff available to market

surveillance authorities

538

Information on resources (subject to availability)

SECTOR 6 -

Aerosol dispensers

€ 9,634.69

0.15992%

36.48%

85.84%

8.64%

0.85%

83.98%

84.35%

SECTOR 7 -

Simple pressure

vessels and

Pressure

Equipment

€ 355,539.54

0.02177%

6.20%

98.48%

71.27%

16.86%

9.67%

30.26%

SECTOR 8 -

Transportable

pressure

equipment

€ 274,911.67

3.25103%

13.80%

81.37%

34.51%

12.07%

41.75%

26.52%

SECTOR 9 -

Machinery

€ 564,027.54

0.02428%

27.98%

80.87%

161.74%

13.32%

11.56%

71.67%

SECTOR 10 -

Lifts

€ 425,111.19

0.01378%

10.15%

98.24%

29.53%

14.60%

5.40%

20.52%

7.1 Budget available to market surveillance authorities

in nominal terms

(€)

7.2 Budget available to market surveillance authorities

in relative terms (%age of total national budget)

8. Staff available to market surveillance authorities (full-

time equivalent units)

9. Number of inspectors available to market surveillance

authorities (full-time equivalent units)

Share of inspections resulting in finding of non-

compliance out of total inspections

Share of self-initiated inspections out of total

inspections

Share of corrective actions taken by economic

operators out of finding of non-compliance

Share of restrictive measures out of finding of non-

compliance

Share of application of sanctions / penalties out of

finding of non-compliance

Share of inspectors out of staff available to market

surveillance authorities

539

Information on resources (subject to availability)

SECTOR 11 -

Cableways

SECTOR 12 -

Noise emissions for

outdoor equipment

SECTOR 13 -

Equipment and

Protective Systems

Intended for use in

Potentially

Explosive

Atmospheres

€

210,451.04

0.00336%

34.65%

77.49%

60.37%

15.31%

12.50%

8.68%

SECTOR 14 -

Pyrotechnics

SECTOR 15 -

Explosives for civil

uses

7.1 Budget available to market surveillance authorities

in nominal terms

(€)

7.2 Budget available to market surveillance authorities

in relative terms (%age of total national budget)

8. Staff available to market surveillance authorities (full-

time equivalent units)

9. Number of inspectors available to market surveillance

authorities (full-time equivalent units)

Share of inspections resulting in finding of non-

compliance out of total inspections

Share of self-initiated inspections out of total

inspections

Share of corrective actions taken by economic

operators out of finding of non-compliance

Share of restrictive measures out of finding of non-

compliance

Share of application of sanctions / penalties out of

finding of non-compliance

Share of inspectors out of staff available to market

surveillance authorities

€ 741,722.38

0.00001%

0.29%

2.96%

25.81%

1.61%

82.26%

16.98%

€ 169,646.69

0.00394%

24.07%

63.47%

77.16%

14.13%

19.23%

24.32%

€ 336,074.13

0.01025%

59.77%

91.28%

11.30%

94.60%

3.54%

50.80%

€ 196,517.44

0.00333%

96.21%

78.33%

0.35%

60.63%

0.08%

15.31%

540

Information on resources (subject to availability)

SECTOR 16 -

Appliances

burning gaseous

fuels

SECTOR 17 -

Measuring

instruments. Non-

automatic

weighing

instruments and

Pre-packaged

products

€ 316,776.94

0.07485%

5.64%

66.96%

14.32%

13.51%

26.58%

90.47%

SECTOR 18 -

Electrical

equipment under

EMC

SECTOR 19 -

Radio and telecom

equipment under

RTTE

SECTOR 20 -

Electrical

appliances and

equipment under

LVD

€ 663,663.40

0.12735%

34.39%

78.16%

29.17%

37.31%

34.75%

75.56%

7.1 Budget available to market surveillance authorities

in nominal terms

(€)

7.2 Budget available to market surveillance authorities

in relative terms (%age of total national budget)

8. Staff available to market surveillance authorities (full-

time equivalent units)

9. Number of inspectors available to market surveillance

authorities (full-time equivalent units)

Share of inspections resulting in finding of non-

compliance out of total inspections

Share of self-initiated inspections out of total

inspections

Share of corrective actions taken by economic

operators out of finding of non-compliance

Share of restrictive measures out of finding of non-

compliance

Share of application of sanctions / penalties out of

finding of non-compliance

Share of inspectors out of staff available to market

surveillance authorities

€ 186,410.22

0.01062%

45.51%

65.60%

42.15%

24.54%

21.18%

46.37%

€

1,213,246.73

0.01320%

58.30%

76.51%

37.07%

10.70%

35.46%

30.37%

€ 1,630,900.55

0.02428%

69.43%

72.99%

28.94%

36.62%

27.91%

63.11%

541

Information on resources (subject to availability)

SECTOR 21 -

Electrical and

electronic

equipment under

RoHS. WEEE and

batteries

€ 191,120.50

0.01399%

SECTOR 22 -

Chemicals

(Detergents.

Paints. Persistent

organic pollutants)

€ 145,000.46

69.55812%

SECTOR 23 -

Ecodesign and

Energy labelling

€ 215,344.26

0.03023%

SECTOR 24 -

Efficiency

requirements for

hot-boilers fired

with liquid or

gaseous fuels

€ 120,923.50

0.00000%

SECTOR 25 -

Recreational craft

7.1 Budget available to market surveillance authorities

in nominal terms

(€)

7.2 Budget available to market surveillance authorities

in relative terms (%age of total national budget)

8. Staff available to market surveillance authorities (full-

time equivalent units)

9. Number of inspectors available to market surveillance

authorities (full-time equivalent units)

€ 284,263.69

0.07500%

Share of inspections resulting in finding of non-

compliance out of total inspections

Share of self-initiated inspections out of total

inspections

Share of corrective actions taken by economic

operators out of finding of non-compliance

Share of restrictive measures out of finding of non-

compliance

Share of application of sanctions / penalties out of

finding of non-compliance

Share of inspectors out of staff available to market

surveillance authorities

25.32%

86.10%

30.28%

26.12%

17.03%

35.20%

22.86%

88.46%

8.85%

29.73%

10.85%

58.46%

28.48%

71.90%

60.65%

16.85%

28.49%

77.42%

61.00%

98.50%

82.42%

5.14%

12.84%

97.88%

39.77%

51.53%

99.48%

17.86%

6.42%

36.75%

542

Information on resources (subject to availability)

SECTOR 26 -

Marine Equipment

SECTOR 27 -

Motor vehicles and

tyres

€ 456,843.17

0.39436%

SECTOR 28 -

Non-road mobile

machinery

€ 14,324.38

0.00334%

SECTOR 29 -

Fertilisers

SECTOR 30 -

Other consumer

products under

GPSD

€ 618,900.94

3.69804%

7.1 Budget available to market surveillance authorities

in nominal terms

(€)

7.2 Budget available to market surveillance authorities

in relative terms (%age of total national budget)

8. Staff available to market surveillance authorities (full-

time equivalent units)

9. Number of inspectors available to market surveillance

authorities (full-time equivalent units)

€ 75,853.75

0.00005%

€ 135,640.69

0.29036%

Share of inspections resulting in finding of non-

compliance out of total inspections

Share of self-initiated inspections out of total

inspections

Share of corrective actions taken by economic

operators out of finding of non-compliance

Share of restrictive measures out of finding of non-

compliance

Share of application of sanctions / penalties out of

finding of non-compliance

Share of inspectors out of staff available to market

surveillance authorities

17.63%

88.35%

21.39%

55.00%

15.28%

86.08%

25.95%

85.96%

62.66%

51.29%

80.83%

85.32%

13.39%

99.38%

68.41%

47.83%

49.57%

100.00%

59.40%

89.27%

7.19%

27.31%

3.55%

77.13%

32.12%

64.93%

27.05%

30.25%

17.70%

47.55%

543

Table 7-10: Application of penalties by market surveillance authorities in the 2010-2013

period

Number of

Member

States

providing

penalties

information

Average number

of penalties

applied per

Member State

and per year

(simple average)

7.93

21.10

123.89

25.38

33.17

49.44

1.66

3.28

12.10

0.81

1.16

5.00

0.88

7.95

0.34

5.08

29.18

51.04

59.40

88.73

6.89

10.98

Sectors

Sector 1 - Medical devices (including in vitro diagnostic medical devices

and active implantable medical devices)

Sector 2 - Cosmetics

Sector 3 - Toys

Sector 4 - Personal Protective Equipment

Sector 5 - Construction Products

Sector 6 - Aerosol dispensers

Sector 7 - Simple pressure vessels and Pressure Equipment

Sector 8 - Transportable pressure equipment

Sector 9 - Machinery

Sector 10 - Lifts

Sector 11 - Cableways

Sector 12 - Noise emissions for outdoor equipment

Sector 13 - Equipment and Protective Systems Intended for use in

Potentially Explosive Atmospheres

Sector 14 - Pyrotechnics

Sector 15 - Explosives for civil uses

Sector 16 - Appliances burning gaseous fuels

Sector 17 - Measuring instruments, Non-automatic weighing instruments

and Pre-packaged products

Sector 18 - Electrical equipment under EMC

Sector 19 - Radio and telecom equipment under RTTE

Sector 20 - Electrical appliances and equipment under LVD

Sector 21 - Electrical and electronic equipment under RoHS, WEEE and

batteries

Sector 22 - Chemicals (Detergents, Paints, Persistent organic pollutants)

544

Sectors

Number of

Member

States

providing

penalties

information

Average number

of penalties

applied per

Member State

and per year

(simple average)

14.10

0.50

0.83

0.14

59.13

3.56

5.48

86.13

Sector 23 - Ecodesign and Energy labelling

Sector 24 - Efficiency requirements for hot-boilers fired with liquid or

gaseous fuels

Sector 25 - Recreational craft

Sector 26 - Marine Equipment

Sector 27 - Motor vehicles and tyres

Sector 28 - Non-road mobile machinery

Sector 29 - Fertilisers

Sector 30 - Other consumer products under GPSD

545

EMPLATE FOR THE

2010-2013

REVIEW AND ASSESSMENTS

546

547

548

549

550

551

552

553

554

555

556

ECTORS COVERED BY

EMBER

TATES REPORTS

Relevant

legislation

Included in the report? (Y/N)

BE BG CZ DK DE EE IE EL ES FR HR IT CY LV LT LU HU MT NL AT PL PT RO SI SK FI SE UK

Product sectors

1. Medical devices

Directives

(including In vitro

93/42/EEC,

diagnostic medical

98/79/EC

devices and Active

and

implantable

90/385/EEC

medical devices)

Regulation

1223/2009

2. Cosmetics

3. Toys

Directive

2009/48/EC

4. Personal

protective

equipment

5. Construction

products

Directive

89/686/EEC

Regulation

305/2011

6. Aerosol

dispensers

Directive

75/324/EEC

557

Product sectors

Relevant

legislation

Included in the report? (Y/N)

BE BG CZ DK DE EE IE EL ES FR HR IT CY LV LT LU HU MT NL AT PL PT RO SI SK FI SE UK

Directives

7. Simple pressure

2009/105/EC

vessels and

and

Pressure equipment

97/23/EC

8. Transportable

Directive

pressure equipment 2010/35/EU

9. Machinery

Directive

2006/42/EC

10. Lifts

Directive

1995/16/EC

11. Cableways

Directive

2000/9/CE

12. Noise

Directive

emissions for

2000/14/EC

outdoor equipment

13. Equipment and

Protective Systems

Intended for use in Directive

Potentially

1994/9/EC

Explosive

Atmospheres

558

Product sectors

Relevant

legislation

Included in the report? (Y/N)

BE BG CZ DK DE EE IE EL ES FR HR IT CY LV LT LU HU MT NL AT PL PT RO SI SK FI SE UK

14. Pyrotechnics

Directive

2007/23/EC

15. Explosives for

civil uses

Directive

93/15/EEC

16. Appliances

Directive

burning gaseous

2009/142/EC

fuels

17. Measuring

instruments, Non- Directives

2004/22/EC,

automatic

weighing

2009/23/EC N

instruments and

and

2007/45/EC

Pre-packaged

products

18. Electrical

equipment under

Directive

electromagnetic 2004/108/EC

compatibility

19. Radio

equipment and

Directive

telecommunication

1999/5/EC

s terminal

equipment

559

Product sectors

Relevant

legislation

Included in the report? (Y/N)

BE BG CZ DK DE EE IE EL ES FR HR IT CY LV LT LU HU MT NL AT PL PT RO SI SK FI SE UK

20. Electrical

appliances and

equipment under

the low voltage

directive

Directive

2006/95/EC

21. Electrical and

electronic

equipment under

Directives

restriction of

2011/65/EU,

hazardous

2002/96/EC Y

substances, waste

and

from electrical and

2006/66/EC

electronic

equipment and

batteries

Regulation

22. Chemicals

648/2004

(Detergents, Paints, Directive

Persistent organic 2004/42/EC

pollutants)

Regulation

850/2004

Directives

23. Ecodesign and 2009/125/EC

Energy labelling

and

2010/30/EU

560

Product sectors

Relevant

legislation

Included in the report? (Y/N)

BE BG CZ DK DE EE IE EL ES FR HR IT CY LV LT LU HU MT NL AT PL PT RO SI SK FI SE UK

24. Efficiency

requirements for

Directive

hot-water boilers 1992/42/EE

fired with liquid or

gaseous fuels

25. Recreational

craft

Directive

1994/25/EC

26. Marine

equipment

Directive

96/98/EC

Directives

2002/24/EC

and

27. Motor vehicles 2007/46/EC,

and tyres

and

Regulation

(EC) No

1222/2009

28. Non-road

mobile machinery

Directive

97/68/EC

29. Fertilisers

Regulation

2003/2003

561

Product sectors

Relevant

legislation

Included in the report? (Y/N)

BE BG CZ DK DE EE IE EL ES FR HR IT CY LV LT LU HU MT NL AT PL PT RO SI SK FI SE UK

30. Other

consumer products Directive

under GPSD

2001/95/EC

(optional)

562

VERVIEW OF INFORMATION PROVIDED FOR THE TOYS SECTOR

Belgium

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

110

(not

including

2660 Rapex

inspection not

divisible by

sector)

2011

2012

2013

639

(not

including

4786 Rapex

inspection not

divisible by

sector)

2251

2078

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

n.a.

2213

1837

241

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

563

No information

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

No information

Bulgaria

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

474

820

105

1224

431

282

1106

1939

2296

1614

1106

830

276

476

1939

820

1119

393

2296

503

1793

266

1614

282

1332

659

2011

2012

2013

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

564

Information on communication activities carried out in the 2010-2013 period (optional)

Six seminars with Bulgarian producers and importers of toys were organised in connection to

the implementation of Directive 2009/48/EC (from 20 July 2011) - one in 2011 and one in

2012, while four seminars were organised in 2013 in connection with the implementation of

the new chemical requirements (from 20 July 2013). Organisers of the seminars were the

Bulgarian Institute for Standardisation and the Bulgarian association of producers and

importers of toys.

At the initiative and with the support of the European Commission, a seminar was organised

in 2012 by the Bulgarian association of producers and importers of toys.

Information on resources (subject to availability)

2010

7.1

7.2

Budget available to market surveillance

authorities in nominal terms

(€)

Budget available to market surveillance

authorities in relative terms (%age of total

national budget)

Staff available to market surveillance

authorities (full-time equivalent units)

Number of inspectors available to market

surveillance authorities (full-time equivalent

units)

653072

2011

649252

2012

650465

2013

608490

B. Assessment of the functioning of market surveillance activities in the sector

The number of toys produced in Bulgaria is small

–

accounting for no more than 10 % of the

market. These are mainly toys made of wood, plastic, soft stuffed toys and sand drawing sets.

The bulk of toys placed on the Bulgarian market is imported from third countries and in

particular from China.

Given the great variety of products, despite the consistent and comprehensive monitoring of

the market, there are still cases of toys marketed with the wrong age restrictions for use by the

manufacturer; missing compulsory warnings on the toy as required in Directive 2009/48/EC

or imprecise specific warnings; Bulgarian instructions for use which do not match the size and

content of the manufacturer's instructions.

565

Czech Republic

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

Number of product related accidents / user

complaints

Number of substantiated complaints by

industry concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the

customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic

operators (“voluntary measures”)

restrictive measures taken

surveillance authorities

market

1053

390

549

925

911

548

1346

1634

1550

1286

1314

Not

recorded

1801

4574

Not

recorded

2011

1682

5435

2012

1440

2108

2013

139

1602

1316

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

A market surveillance authority (specifically the Czech Trade Inspection Authority) works

with the audit authority to hold public seminars approximately twice a year at toy exhibitions

and trade fairs. In addition, the Czech Trade Inspection Authority staff answers all written and

telephone enquiries made by the general public. In general, public health authorities under the

Ministry of Health organise various training events or participate in those held by various

institutions or professional associations. There is regular cooperation, for example, with

566

PROKOS (the association of cosmetics manufacturers) and ČSZV (the Czech Association for

Branded Products), whose training events are routinely attended by public health authorities

delivering contributions on legislation and the results of surveillance activities. The situation

is much the same with associations of packaging material manufacturers, with which there is

also intensive communication. In addition, public health authorities regularly organise various

seminars and workshops with professionals as a means to exchange experiences. The most

extensive series of seminars was held in 2013 with the aim of familiarising the public with

new legislation on cosmetics, particularly in relation to the EU’s Cosmetic Products

Notification Portal (CPNP).

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

The Czech Trade Inspection Authority’s activities in this sector have sought to

guarantee the

same level of consumer protection and consumers’ legitimate interests (i.e. life, health,

property and the natural environment) within the EU internal market. Consumer product

inspections concentrated primarily on third-country products, which were assessed in

cooperation with customs authorities before they were released into free circulation in

accordance with European TAXUD methodology.

The Czech Trade Inspection Authority is involved in international surveillance actions which

are concerned, entirely or marginally, with the Toy Safety Directive and which are financially

supported by the European Commission.

Since 2012, it has participated in a joint international surveillance project, co-financed by the

European Commission and organised by Prosafe JA China 1 and JA China 2, which has yet to

be completed.

The project seeks to establish a platform for cooperation with Chinese customs and

surveillance authorities on the one hand and with EU customs and surveillance authorities on

the other. The cooperation established should engender confidence in the safety of imported

products and facilitate trade between China and the EU. In this context, another pilot project

will be launched this year for the mutual assessment and recognition of the conformity of

products covered by the Toy Safety Directive.

State health surveillance under the responsibility of the Ministry of Health draws on annual

national and regional inspection plans based on methodology and compiled centrally by the

Ministry of Health. The preparation of these plans is rooted in the market situation and an

analysis of past results of state health surveillance, an analysis of legislative requirements and

an assessment of the risk posed by products to consumers. Every year, targeted tasks of the

Chief Health Officer are announced, which focus on nationwide problems that have been

singled out. Regionally, targeted tasks

–

aimed at addressing problems typical for the region

–

are also carried out. In 2013, the focus was on dolls containing soft plastic parts, based on

RAPEX notifications and internally conducted market research. This corroborated the

presence of high concentrations of such toys, especially in ‘Asian marketplaces’. This

surveillance was carried out to confirm the high content of phthalates in soft plastic parts to a

level that exceeded the limit established by the REACH Regulation and could threaten the

health of the youngest members of the population, for whom these toys are intended.

567

In 2013, there were 408 toy inspections encompassing 1 550 products. A total of 258 product

samples were taken for laboratory analysis; 142 of these products were classified as

substandard. Customs administration authorities cooperated in the inspections of toys (dolls)

with soft plastic parts

–

this product type was inspected upon entry into the Czech Republic

and also directly on the market. In all, 87 products were declared unsafe, and a relatively large

number of substandard products were seized by the customs authorities at the border and

subsequently destroyed. Market inspections reveal problems with the sale of this type of

product at markets, in particular ‘Asian marketplaces’, as the product origin cannot be traced

because, in most cases, only the name of the vendor is known. Documents intended to prove

the origin of a product, such as invoices, are false, if they exist at all. In some cases, non-

existent barcodes, or companies that do not trade in the given type of product, are reported.

Furthermore, it was found that, after a certain period of time had passed, products previously

declared unsafe were placed back on sale, sometimes rebranded.

Denmark

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

133

138

2011

133

2012

2013

Data available from the Environmental Protection Agency only.

The table covers the number of products and not the number of inspections. The number is based on an average.

A significant proportion took place as the result of complaints from consumers, possibly as the result of accidents.

All product inspections within the jurisdiction of the Danish Safety Technology Authority include a physical check. Figures reflect

the number of products and not the number of inspections. They cover both the Danish Safety Technology Authority and the Danish

Environmental Protection Agency.

568

2010

5.2

5.3

5.4

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures taken

surveillance authorities

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

market

2011

2012

2013

Information on communication activities carried out in the 2010-2013 period (optional)

The Environmental Protection Agency holds two dialogue meetings a year with the toy sector.

At these meetings, both the Environmental Protection Agency and the sector provide

information about what has happened since the last meeting, and they discuss anything that

needs to be clarified in relation to both regulation and case handling. In addition to this, the

Environmental Protection Agency also published a folder in collaboration with the Danish

Safety Technology Authority in 2010, containing ten good tips for the procurement and

handling of toys, aimed at buyers in local authorities and day-care institutions:

http://www.sik.dk/Global/Publikationer/Foldere/10-gode-raadtil-haandtering-og-indkoeb-af-

legetoej

In order to help toy distributors gain an overview of their obligations, the Danish Safety

Technology Authority produced a folder in 2012, for distribution during visits to shops. The

folder is also available on the website:

http://www.sik.dk/content/download/23244/300319/version/1/file/Til_distributoerer_af_leget

oej_rev_+maj_2014.pdf.

The Danish Safety Technology Authority is happy to make contributions concerning rules,

etc. on toys, in order to give the sector the best basis for complying with the rules and only

producing and dealing in safe toys. This is primarily done through dialogue meetings every

six months, but also for example at the Nordic and Baltic Information Seminar on Toy Safety,

which was held in Malmö on 20 September 2012.

The Danish Safety Technology Authority has

taken part in the Commission’s employee

exchange. One colleague involved in toys (as well as one colleague involved in electrical

products) was therefore on exchange at the NVWA in the Netherlands in January 2013. In

2013, the Danish Safety Technology Authority undertook a strategic fact-finding initiative on

consumer behaviour with a view to producing information materials about the proper use of

products. The investigation found that Danish consumers do not perceive toys as risky. They

therefore do not read instructions for use or warning labels, and they make up their own rules.

Some 16 % of consumers therefore said that they have never refrained from buying a toy

purely because it has a warning symbol indicating that it is ‘not suitable for children aged

3’.

For infringements that do not have any significance for safety, the Danish Safety Technology Authority provides

guidance/recommendations to the person responsible. Such infringements are not included in the figures.

569

Information on resources (subject to availability)

2010

7.1

7.2

Budget available to market surveillance

authorities in nominal terms

(€)

Budget available to market surveillance

authorities in relative terms (%age of total

national budget)

Staff available to market surveillance

authorities (full-time equivalent units)

Number of inspectors available to market

surveillance

authorities

(full-time

equivalent units)

381800

2011

213300

2012

168400

2013

169700

0.00056%

0.00031%

0.00024%

2.08

1.46

1.62

1.67

0.58

1.06

1.23

1.27

B. Assessment of the functioning of market surveillance activities in the sector

Environmental Protection Agency:

Access to market surveillance in this sector is risk-based. Initiatives in the form of

information, guidance and controls are organised and carried out on the basis of risk

assessments, based on knowledge from scientific work and news in a broad sense, the age of

the rules and the scope of consolidated guidance, the number of reported cases, including via

Rapex, and the number of infringements detected during controls. The prioritisation of this

product area therefore varies. Information, guidance and controls in collaboration with the

Danish Safety Technology Authority have been given a high priority in 2014, particularly

information and guidance, as part of a special initiative on the safe use of products for

children.

Danish Safety Technology Authority:

The Authority’s experience is that it is appropriate to keep the sector informed of the focus

that the forthcoming proactive initiatives on toys will have. The potential shop types are thus

prepared for the possibility of controls, and they can therefore instruct their employees how to

react when the authorities pay a visit. A broader, earlier effect is thus achieved in the form of

self-discipline. In order to measure the impact that a market surveillance initiative has had,

including follow-up activities (usually concluding communication with the sector or

consumers), the Authority has repeated some initiatives at intervals of a few years. The

Danish Safety Technology Authority has compared the results of the magnetic toy initiative

from 2012 with the previous initiative, which ran from 2007 to 2010. There has been an

improvement, since 36 % of the toys that were selected posed a danger to consumers,

compared to 60 % previously. We published the following article:

http://www.sik.dk/Global/Publikationer/Artikler/OEvrige-artikler/2012/Sikkerheden-

vedmagnetlegetoej-kan-stadig-forbedres

Application of the Market Surveillance Regulation to the toy sector poses some challenges,

including the following:

570



Agents: The legal position for agents must be clarified, i.e. whether an agent may be

treated as part of the distribution chain and have the associated responsibilities. The

Danish Safety Technology Authority will therefore work to clarify this with the

Commission.

What should be done if the manufacturer responsible has been declared bankrupt or has

otherwise ceased to exist? Can the product continue to be sold, and what liability do the

other players in the distribution chain have with regard to procuring technical

documentation for product safety?

Manufacturers (and test laboratories) are not particularly aware of the fact that a

standard must be harmonised in order for them to assume compliance with the safety

requirements contained in the Toy Directive when the standard is complied with.



Germany

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

No information

Information on communication activities carried out in the 2010-2013 period (optional)

No information

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

No information

Estonia

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

Surveillance activities in numbers

Total number of inspections

Number of notices sent by the Tax and

Customs Board

2010

427

2011

396

2012

382

2013

401

571

Total number of products inspected

Number of products tested

847

584

442

369

Results of surveillance activities

Number of non-compliant products

Number of products presenting a serious risk

2010

2011

2012

2013

Measures applied

Number of memos

Number of orders

Number of penalty payments and total

amount

Number of substitutive enforcements

Number of misdemeanour procedures

Fines imposed as part of a misdemeanour

procedure

2010

2011

2012

2013

Products withdrawn from the market

Total number of products withdrawn from

the market

Number of

consumers

products

recalled

from

2010

2011

2012

Data not

available

2013

Data not

available

Number of voluntary measures taken by

economic operators

The total number of products inspected by only one authority, the Health Board, has been given here. The total number of products

inspected by the Consumer Protection Board is not available. With the current information system, it is only possible to return the

number of inspection visits. At the same time it is known that the total number of products inspected by the Consumer Protection

Board in 2011 was approximately 1 670.

For the Consumer Protection Board, it is only possible to give the number of non-compliant products out of the products tested. The

percentage of infringements detected during the inspection visits was as follows: 2010

–

40.1%; 2011

–

34.4%; 2012 - 33%; 2013

–

63.5%.

For the Consumer Protection Board, only the number of memos is available.

The data for 2010–2011 consist of data from both of the authorities; there are no data available about the Consumer Protection

Board for 2012–2013. Number of product articles.

The data from 2010–2011 consist of data of the Consumer Protection Board. The Health Board has no data available.

Only data from 2010 are available for the Consumer Protection Board. The data from 2011–2013 consist only of the data for the

Health Board.

572

Information on communication activities carried out in the 2010-2013 period (optional)

As far as toys are concerned, the Health Board has inspected whether the requirements laid

down in Directive 2009/48/EC and 2001/95/EC of the European Parliament and of the

Council and in the REACH regulation have been implemented. Special attention has been

paid to the mechanical and physical properties of toys meant for children below three years of

age since such toys may cause choking and injuries to the most vulnerable target group. The

Health Board has also studied the phthalate content of rubber toys and childcare products, as

phthalates are reproductive toxicants and may cause fertility problems in the long term.

Every year

the Health Board carried out the ad hoc study “Inspection of possible phthalate

content in childcare products and soft toys”. The aim of the ad hoc study was to find out

whether the childcare products (toys, childcare articles, etc.) on the Estonian market are in

conformity with the requirements of point 51 of Annex XVII to Regulation (EC) No

1907/2006 of the European Parliament and of the Council (REACH).

During the ad hoc inspection, a total of 60 products per four years were inspected, of which

10 products (16%) were not in conformity with the requirements. In 2010 and in 2011 the

Consumer Protection Board along with 14 market surveillance authorities took part in a

project on toys financed by the European Commission and managed by the PROSAFE

cooperation network. The aim of the project was to ensure that only safe toys were on the EU

market; the project was aimed at inspecting magnetic toys, the content of small parts in toys

and the content of heavy metals in toys. The project resulted in the preparation of several

instructions and reference materials for the organisation of surveillance over toys.

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

No information

Ireland

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

2011

2012

2013

The Agency is unable to provide detailed statistical information in relation to enforcement activities as detailed in this section as the

data relating to complaints, investigations and inspections is not recorded by the Agency in a comparable format and the Agency is

not in a position to devote resources to detailed statistical analysis of this data at this time.

573

2010

3.1

Number of inspections (total number)

number of reactive inspections

2011

2012

3 (not

limited to

toys)

2013

9 (not

limited to

toys)

3.2

3.3

number of self-initiated inspections

number of inspections prompted by the customs

3 (not

limited to

toys)

9 (not

limited to

toys)

4.1

4.2

5.1

5.2

5.3

5.4

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

n.a.

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

The National Consumer Agency hosts and operates 2 websites as follows ;

Agency corporate-focused website

–

http://corporate.nca.ie/eng/.

This website provided

information and guidance relating to business and corporate product safety issues

including information on the role of the Agency as Ireland's market surveillance

authority for safety of products covered by the EU Directives, product safety guidelines

and responsibilities for businesses, and related ‘Frequently Asked Questions’ (FAQs),

links to specific sectoral information including toy safety and magnetic toys, RAPEX

weekly summary reports, product safety recalls, press releases, business zones guides

including a Toy Safety page, Guide to Toy Safety, Toy Safety Tips and links to the

relevant Irish legislation containing the transposed legislation.

General consumer-focused website at

http://www.consumerhelp.ie/

with information on

the role of the Agency as Ireland's market surveillance authority for safety of products

Representative items from customs consignments were visually and physically checked.

The Agency achieved voluntary corrective actions (where necessary) in majority of cases.

574

covered by the EU Directives, enforcement of product safety legislation, investigation

of complaints about unsafe products, alerting consumers about unsafe products by

posting product recalls and RAPEX notifications detailing all product recalls that have

taken place in the European Union, and general information for consumers on Toys and

Play Equipment .

October 2010 -

The National Consumer Agency hosted the ‘Seminar on new EU Toy Safety

Directive’ an information seminar on the requirements of the new EU Toy Safety Directive

for industry.

2012

–

NCA participated in a training event hosted by the Chambers of Commerce and TIE to

raise awareness about the new EU Toy Safety Directive and related standards.

Information on resources (subject to availability)

2010

7.1

7.2

Budget available to market surveillance

authorities in nominal terms

(€)

Budget available to market surveillance

authorities in relative terms (%age of total

national budget)

Staff available to market surveillance

authorities (full-time equivalent units)

Number of inspectors available to market

surveillance authorities (full-time equivalent

units)

7200000

2011

6300000

2012

5200000

2013

4800000

n.a.

B. Assessment of the functioning of market surveillance activities in the sector

The National Consumer Agency (NCA) is the statutory body established by the Irish

Government to enforce consumer law and promote consumer rights with responsibility for

market surveillance in respect of the safety of a wide range of non-food consumer products.

Our role in relation to product safety includes enforcing product safety legislation,

investigating complaints about unsafe products, carrying out surveillance activities, alerting

consumers about unsafe products, advising manufacturers, suppliers, retailers and their

representative bodies about their responsibilities, and managing Ireland’s input to the EU

product safety rapid alert system, RAPEX

The National Consumer Agency has also contributed to the National Sector Specific Market

Surveillance Programmes 2010 -2011 and 2012

–

2013.

The Budget across is the total NCA budget for all activities (excluding financial awareness and education). It is not possible to

identify the specific amount of the annual budget which is directly related Product Safety Market Surveillance or related activities.

Number of authorised officers in Product Safety Unit with additional authorised Officers available to assist on specific projects if

required.

Number of authorised officers in Product Safety Unit with additional authorised Officers available to assist on specific projects if

required.

575

Greece

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

Number of product related accidents / user

complaints

Number of substantiated complaints by

industry concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the

customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic

operators (“voluntary measures”)

restrictive measures taken

surveillance authorities

market

2011

2012

2013

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

No information

For the year 2012, the three prohibitions/withdrawals relating to samples with an abnormal phthalate content were issued by the

General Chemical State Laboratory (Directorate for the Environment). For the year 2013, the prohibition/withdrawal relating to a

sample with an abnormal phthalate content was issued by the General Chemical State Laboratory (Directorate for the Environment).

Fines as well as mandatory measures (withdrawals) were imposed on economic operators.

576

Information on resources (subject to availability)

2010

7.1

7.2

Budget available to market surveillance

authorities in nominal terms

(€)

Budget available to market surveillance

authorities in relative terms (%age of total

national budget)

Staff available to market surveillance

authorities (full-time equivalent units)

Number of inspectors available to market

surveillance authorities (full-time equivalent

units)

2011

2012

2013

B. Assessment of the functioning of market surveillance activities in the sector

From 2010-2013, the market surveillance authority for toys carried out 113 inspections,

involving the inspection of 261 outlets for toys throughout Greece (importers, distributors and

manufacturers) and 900 types of toy were given mainly visual inspections.

All this was carried out at virtually zero financial cost.

Fines totalling EUR 111 611.60 were established and collected.

Spain

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

No information

Information on communication activities carried out in the 2010-2013 period (optional)

No information

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

No information

The annual budget for resources and training related to the General Secretariat for Industry's entire market surveillance operation

(for this purpose rows 7.1 and 7.2 have not been completed, which relate exclusively to toys).

The annual budget for resources and training related to the General Secretariat for Industry's entire market surveillance operation

(for this purpose rows 7.1 and 7.2 have not been completed, which relate exclusively to toys).

577

France

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

4.1

4.2

5.1

5.2

5.3

5.4

Number of product related accidents / user

complaints

Number of substantiated complaints by

industry concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic

operators (“voluntary measures”)

restrictive measures taken

surveillance authorities

market

380

n.a.

341

n.a.

401

n.a.

326

n.a.

868

18500

773

15000

877

19000

790

17000

n.a.

3773

3758

2011

n.a.

2694

2674

2012

n.a.

2224

2204

2013

2644

2639

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

No information

Information on resources (subject to availability)

2010

7.1

Budget available to market surveillance

authorities in nominal terms

(€)

2000000

2011

1620000

2012

1300000

2013

1320000

Doesn’t include the budget for product testing.

578

2010

Staff available to market surveillance

authorities (full-time equivalent units)

Number of inspectors available to market

surveillance authorities (full-time equivalent

units)

26.5

2011

20.5

2012

21.5

2013

21.5

B. Assessment of the functioning of market surveillance activities in the sector

No information

Croatia

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

384

150

144

2011

2012

2013

Data only between 1 July 2013

–

31 December 2013

579

2010

5.4

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

2011

2012

2013

Information on communication activities carried out in the 2010-2013 period (optional)

No information

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

No information

Italy

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

No distinguishable information provided: combination of sector 3 and 30

2010

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

415

1168

218

1305

450

547

259

1567

372

205 (A)

13 (C)

2011

229 (A)

13 (C)

2012

96 (A)

11 (C)

2013

275 (A)

7 (C)

3.1

3.2

3.3

4.1

4.2

580

2010

5.1

5.2

5.3

5.4

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

2011

228

2012

2013

185

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

No information

Information on resources (subject to availability)

No distinguishable information provided: combination of sector 3 and 30

2010

7.1

7.2

Budget available to market surveillance

authorities in nominal terms

(€)

Budget available to market surveillance

authorities in relative terms (%age of total

national budget)

Staff available to market surveillance

authorities (full-time equivalent units)

Number of inspectors available to market

surveillance authorities (full-time equivalent

units)

n.a

2011

n.a.

2012

n.a.

2013

n.a.

n.a

n.a.

100 (NAS)

n.a.

B. Assessment of the functioning of market surveillance activities in the sector

Following the RAPEX alerts on microbiological or chemical issues relating to consumer

products (toys and other), under the responsibility of the Ministry of Health, NAS (the Health

Protection Unit of the Carabinieri) launched a review of the national market. The main issues

reported include a lack of detailed information as to the distribution network, imports via

unofficial channels and the lack of documentation and invoices showing the origin of the

products. The lack of resources significantly restricts the ability to perform control tests.

581

Cyprus

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

n.a.

1183

893

775

742

1257

n.a.

2011

962

n.a.

2012

834

2013

785

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

Information sheets are sent to toy importers, informing them of their obligations and giving

them advice and instructions. Furthermore, regular visits are paid to distributors and

importers, during which they are given oral information and submitted to inspection. In

addition, information material on the implementation of the Toy Safety Directive has been

printed (30 000 copies) and will be distributed to importers, distributors and consumer

organisations. Moreover, all the communications from the department relating to toys are

notified to consumer organisations and associations of economic operators.

582

A seminary-workshop was held on 22 September 2011 as part of the pan-European campaign

for the CE marking. The seminar was intended primarily for economic operators, as well as

consumers. The new Toy Safety Directive was presented as part of that seminar. The

department also took part in the Christmas pan-European Toy Safety Campaign (December

2011).

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

Market surveillance activities in relation to toys are being carried out almost on a daily basis,

throughout the territory of Cyprus. In particular, inspectors carry out inspections on the basis

of the RAPEX weekly report (which includes toys), and at the same time they conduct visual

and physical inspections of toys.

In addition, samples of toys are taken and examined twice a year. Usually, the first sampling

(2nd quarter of the year) includes 30 toy samples, the physical and mechanical properties

(ΕΝ71-1)

of which are examined, and the second sampling (4th quarter of the year) includes

30 toy samples which are tested for the

migration of heavy metals (ΕΝ71-3).

All laboratory

tests are performed by the State General Laboratory. The exact sampling schedule is

established in an agreement between the two parties at the beginning of each year. Other

laboratory tests may be conducted in the context of our participation in EU programmes, e.g.

PROSAFE.

Finally, inspection campaigns are being carried out with respect to specific toy categories

(e.g. inflatable toys, skates, projectile toys) or in specific sales premises of toys (e.g. open-air

markets).

Inspection methodology:

Conducting visual and physical inspection of toys. These inspections are usually performed

on own initiative and/or on the basis of the RAPEX notification. In some cases, these

inspections are performed following consumer complaints.

The actions/procedures followed are:

•

checking the CE marking;

checking the warnings that should be affixed on toys;

assessing the compliance of toys with the basic safety requirements of the applicable

national legislation;

physical inspection of toys for children under the age of 3 for detachable small parts,

sharp points, laces, liquids, etc.;

if there are doubts about any toy, all relevant information and documentation in relation

to the product are requested from the economic operator;

conducting sample checks on products and carrying out laboratory tests on them;

583

•

taking measures when it is found that toys do not comply with the safety requirements

of the applicable national legislation.

The specific market framework on which the surveillance scheme is carried out:

•

Assumptions as to the size of the national market: n.a.

Number of manufacturers: 1

Number of importers: 68

Number of distributors: 397

Import volume (third countries): EUR 16 459 997.00

Latvia

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

153

145

109

n.a.

153

151

2011

n.a.

2012

n.a.

145

2013

n.a.

109

584

2010

5.4

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

n.a.

2011

n.a.

2012

n.a.

2013

n.a.

Information on communication activities carried out in the 2010-2013 period (optional)

No information

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

No information

Lithuania

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

No information

Information on communication activities carried out in the 2010-2013 period (optional)

No information

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

No information

585

Luxembourg

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

2011

2012

2013

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

Surveillance was carried out sporadically in retail outlets. These inspections comprised visual

inspections of labelling and the documentation provided. Systematic verification was carried

out together with officials of the Administration des Douanes et Accises at import.

Information on resources (subject to availability)

No information

586

B. Assessment of the functioning of market surveillance activities in the sector

No information

Hungary

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

207

161

130

305

237

197

479

223

153

512

230

137

1422

2695

2476

2094

1153

465

683

2011

1510

571

926

2012

1015

352

656

2013

1043

393

641

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

In its communication activities, the NFH gives priority to communicating product safety

information to consumers and economic operators. The Authority continuously publishes

news, information and changes in legislation relating to market surveillance and individual

587

product groups, as well as dangerous products prohibited by the Authority, on its website and

Facebook account. In addition, news about the market surveillance activities of the Authority

is regularly published in various media (national and local television and radio stations,

Internet and written press), and information is provided about these in its official journal and

newsletter. Furthermore, the Authority tries to draw the attention of the public to products

posing a risk with laboratory open days, roadshows and campaigns.

Information on resources (subject to availability)

2010

7.1

7.2

Budget available to market

authorities in nominal terms

(€)

surveillance

317192

2011

522807

2012

465263

2013

461052

Budget available to market surveillance

authorities in relative terms (%age of total

national budget)

Staff available to market surveillance

authorities (full-time equivalent units)

Number of inspectors available to market

surveillance authorities (full-time equivalent

units)

0.000637

0.00105

0.000837

0.0008

B. Assessment of the functioning of market surveillance activities in the sector

The consumer protection authority examined the following types of toys between 2010 and

2013:

•

Dolls/doll kits: according to experience, 90 % of the products analysed have a high

phthalic ester-type softener content in the heads of dolls. Instead of the heads of dolls,

the softener is mostly located in the bodies of dolls and other accessories. 18 % of the

labelling is incomplete, 4 % of the products do not have conformity documentation. The

complaint ratios were nearly equal in all three years.

Projectile toys: their most typical defect is the separation of the suction disc and the

higher than permitted phthalic ester-type softener content of the suction disc. This

product group was also inspected as part of sample testing/individually every year; the

Authority increasingly often encountered phthalic-free products in 2013 and this year.

Projectiles are already made of different materials, thus they do not contain any softener

and the design of projectiles has been changed: they consist of a piece cast in one

mould, thus they have no small part that can get separated. In terms of labelling, 25 %

of them are inadequate, and 3 % do not have conformity documentation.

Toys for children under the age of three: Of the baby toys tested in 2012, 112 types or

388 toys (20.9 %) were complained about due to inadequate markings, labels and

warnings. During the inspections, samples were taken from 14 toys presumed to be

suspicious from a safety point of view. On the basis of the results of laboratory tests,

two baby toys proved to be dangerous. One baby chew toy represents a serious risk to

small children from the point of view of choking hazard, while a pram rattle poses a

•

588

high risk in terms of eye injuries. In 2013, the product group was examined as part of

laboratory tests, where dangerous softeners were also found in a small proportion. In the

case of this product group, manufacturers pay greater attention to hazards posed by

small parts and pull cords. The documentation was correct in the case of 85.7 % of the

toys.

•

Bubble blowers/replenishers: In the case of this product group, microbiological analyses

were carried out on several occasions. In 25 % of the cases, microbiological infections

were found, in one case due to a specific defect of the product.

Tricycles and scooters: The majority of the products did not meet the requirements set

for load-bearing capacity, brakes, stability, burr and sticking. With regard to labelling,

product-specific warning notices were incomplete or completely missing.

Textile puppets (2013) and textile doll clothes (2012): The Authority analysed these

products for their azo-dye content (in specific analyses); in two analyses, one product

did not meet the requirements.

Expanding toys: A very small group of toys belongs to the group of expanding toys: In

20 % of these products, they expand too much (several fold in size). The Authority

checked these products, too, in its own laboratory tests and sampling tests every year.

Make-up kits: They were not subjected to independent thematic reviews, but about 10

of them were tested (randomly and through consumer complaints) every year. In terms

of microbiological and heavy metal content, the products meet the requirements.

Toy

books: During the inspection of children’s books, a total of 20 products were

sampled, of which deficiencies relating to the conditions of distribution were

established in the case of 12 (60 %), and non-conformity affecting product safety, which

represents a medium risk, was established in the case of one (5 %). It can be stated from

the experience gained that the manufacturers and importers are not aware of the fact that

they have to meet not only the requirements set for books, but also those set for

children’s

toys. They do not know the boundary between books and toys. In many

cases, therefore, conformity markings were not shown either.

Toy mobile phones: The Authority inspected these product groups as part of

independent thematic reviews in 2011 and 2012. On both occasions, the Authority

established that the volume emitted was too high in nearly 82 % of the products, 30 %

did not conform to the structural specifications, and 17 % were malfunctioning.

•

On the basis of experience of the past period, it can be stated that it is a frequent problem in

the case of toys that the documentation certifying the conformity of the product is incomplete

or inadequate. In the case of EC declarations of conformity, the most frequent errors are the

name and ID number of the registered organisation. The inspection of a significant part of the

products is carried out by an (unregistered) Chinese subsidiary of a registered organisation.

Another error is the ambiguous identifiability (lack/quality of photograph, difference in

identification markings). It is an error that occurs less frequently, but so much the more

significant, that the product is examined in accordance with inappropriate standards or

conformity with the required regulations is not examined, thus not all hazards arising during

normal use are taken into account by the manufacturer.

589

Malta

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

108

112

149

101

2011

127

2012

159

2013

162

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

No information

Information on resources (subject to availability)

No information

590

B. Assessment of the functioning of market surveillance activities in the sector

Toys are one of the priority product groups for the Market Surveillance Authority in Malta.

Hence, these products feature prominently in the national market surveillance’s annual

programme. After an initial period of around 3 years in which economic operators were not

fully aware of the operations of the market surveillance authority in Malta, and which resulted

in a lack of action from the part of the operators to respond to findings by the surveillance

authority, an increase in voluntary measures was encountered as awareness increased.

Netherlands

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

No information

Information on communication activities carried out in the 2010-2013 period (optional)

No information

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

In 2012 and 2013, 135 manufacturers and importers of toys were inspected, though it should

be noted that some of these companies were trading in many different product groups. Much

emphasis was placed on the contents of technical files. Many of the technical files were found

to be still missing or incomplete.

From 2011 to 2014, 630 toy samples were examined in terms of their physical and mechanical

safety. The focus is on toys for children under 3 years old and especially on combating the

risk of choking.

In addition, various groups of toys (wooden and plastic toys, balloons, finger paints, fancy

dress costumes, playhouses/tents and cuddly toys) were examined in terms of their chemical

safety. Depending on the type of material, they were tested for plasticisers, heavy metals,

AZO dyes, preservatives and nitrosamines. Fire safety was also inspected. To this end, tests

were conducted to verify compliance with the requirements of Annex XVII to the REACH

regulation and those of the GPSD. A general compliance level of 90 % was found. An

inspection of the microbiological safety of cuddly toys did not reveal any deviations.

591

Austria

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

n.a.

592

n.a.

202

n.a.

2011

n.a.

461

n.a.

114

n.a.

2012

n.a.

702

n.a.

229

n.a.

2013

n.a.

579

n.a.

109

n.a.

Sampling and reviews together

n.a.

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

Information on websites, booklets: Toy booklet produced by the Federal Ministry of Health as

of 2009; second booklet produced in association with the Austrian Federal Economic

Chamber (WKO) in 2011, both available on the homepage:

http://bmg.gv.at/home/Schwerpunkte/VerbraucherInnengesundheit/Spielzeug/Ratgeber_zur_S

pielzeugwahl

Educational, informational and training events, particularly during 2010 and 2011 prior to the

coming into force of the new Toy Safety Directive 2009/48/EC.

592

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

Market surveillance for goods subject to the Austrian Food Safety and Consumer Protection

Act (LMSVG)

–

i.e. food, drinking water, food-contact materials (materials intended to come

into contact with food), toys, and cosmetics

–

follows the indirect federal administration

structure. The system of controls is described in the Food Safety Report (LMSB), which is

produced annually.

Link:

https://www.verbrauchergesundheit.gv.at/lebensmittel/lebensmittelkontrolle/LMSicherheit.ht

The Federal Ministry of Health coordinates the control and surveillance activities by

producing an annual Inspection Plan (Sampling and Review Plan), which has to be adhered to

by the relevant supervisory authorities in the federal provinces. The extent to which these

requirements are met is set out in a comparison of target versus actual performance.

To ensure consistent surveillance and a risk-oriented approach, specially developed

procedures are adhered to during the surveillance activities. Internal audits are also held at

regular intervals to ensure compliance with the quality assurance system. In addition, in July

2014 a report was submitted to the responsible department of the Directorate-General for

Enterprise and Industry, in accordance with Article 48 of the Toy Safety Directive

2009/48/EC.

The sector in Austria features many small and medium-sized businesses, predominantly retail

companies. A large percentage of the products come to Austria from other Member States.

The LMSVG stipulates that products on the market must be inspected, as well as the

businesses themselves; the number of breaches determined refers to the total of both types of

inspections. The most common defect was incorrect labelling. The large degree of fluctuation

results from there being a different focus of inspection each year (for example, cheap toys

sold at fairs).

Poland

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

Number of product related accidents / user

complaints

n.a.

2011

249

2012

188

2013

209

593

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of

customs

inspections

prompted

the

n.a.

925

n.a.

2011

n.a.

727

132

478

113

2012

n.a.

662

111

475

129

2013

n.a.

702

123

493

243

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures taken

surveillance authorities

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

market

512

486

364

1082

369

1047

383

1016

477

925

456

727

544

662

516

702

Information on communication activities carried out in the 2010-2013 period (optional)

No information

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

Controls of toys were carried out by the Trade Inspectorate continually. In the years 2010

–

2013 controls covered 14670 products, challenging 5003 of them. Controls covered, among

other things: soft stuffed toys, dolls, baby toys for watching, catching and/ or squeezing; art

and handicraft materials and similar articles, books used in playing, costumes, fancy dress and

The number of opinions issued at the request of the customs authorities is given.

Estimate data. In case of some authorities the number of products is given.

The number of operations is given.

The number of measures applied is given.

The number of administrative decisions is given.

594

masks, toys for developing skills, toys found in foodstuffs, toys for playing in sand and in

water, toys for playing in water, toys - equipment for sports games and balls, toys into which

a child can enter, audiovisual equipment, construction toys and puzzles, sets for

experimenting, functional toys, game sets, and mechanically and/or electrically propelled

vehicles.

For the last few years there has been a noticeable trend on the Polish market of a similar

proportion of toys queried in relation to toys which were in compliance with the requirements.

Approximately one third of toys checked during a given calendar year are challenged.

Polish operators continue to have problems with correct age classification of toys. As a result,

they put incorrect markings on toys, or do not even place any warnings essential for children's

carers buying toys.

However, it should be stressed that instructions and warnings are easy to correct and operators

have no problems with voluntarily following the recommendations of inspectors.

Another frequent irregularity is an indication of "adult supervision" being necessary. It should

be noted that such supervision is necessary only in respect of toys whose use can be

dangerous, e.g. functional toys, toys for keeping a child afloat, or chemical toys. Such a

warning can mislead a parent making a purchase by suggesting dangers which do not actually

arise.

The most frequent danger which has a direct impact on children's safety is the presence of

small particles (whether they separate automatically or appear as a result of using a little

force). In addition, tests performed every year indicate the presence of other serious risks

which have a negative impact on children's' health. They include, for example, exceeding the

admissible acoustic pressure level in toys emitting sounds (this creates a risk of damage, or

even loss, of hearing), the presence of sharp and jagged edges (risk of injury or wounds), or

the presence of chemical substances which have a negative impact on reproductive and

hormonal systems (phthalates - in 2013, in every third sample tested the acceptable

concentration level of these substances was exceeded).

There may be many reasons for these non-compliances. However, the most probable is the

absence on the part of operators placing toys on the market, of sufficient knowledge of

applicable provisions regarding the assessment of compliance. Regular checks by the Trade

Inspectorate regarding correct assessment of compliance of toys with essential requirements

raise the awareness of operators, in particular importers, indicating how important it is to

check and confirm that goods placed on the market meet the relevant requirements.

595

Portugal

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

n.a.

2011

n.a.

2012

453

133

320

n.a.

2013

405

261

144

n.a.

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

[ASAE]

With the publication of Directive 2009/48/EC, internal training activities were held

for its inspectors, in which they were made aware of changes to the legislation on toy safety.

Documentary inspection procedures, checklists and sample collection procedures were drawn

up, so as to cover various types of toys, with the aim of creating an operating methodology for

all cases covered by legislation.

Compulsory measures to prohibit or restrict the product being made available on the national market, to withdraw it or to recall it.

These measures are taken when the economic operators did not follow up on a previous request from market-surveillance authorities

to take corrective action, or where authorities have to intervene urgently.

596

The ASAE held an information session for secondary school pupils in February 2011. The

session covered toys typical of the carnival season, with specific focus on their labelling and

general principles of the CE marking and its meaning.

Following an invitation from Toy Industries of Europe (TIE), the ASAE participated as a

speaker in the Seminar on Toy Safety held in Madrid in October 2012. This event, funded by

the European Commission, was organised by TIE in collaboration with the Spanish

Association of Toy Manufacturers (AEFJ). It was mainly aimed at Portuguese and Spanish

economic operators representing various parts of the supply chain (manufacturers, importers

and distributors) and testing laboratories.

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

[ASAE]

The

ASAE participated in a joint action called Joint Action 2010 ‘Children's Fancy

Dress Project’ organised by PROSAFE (Product Safety Forum of Europe) and supported by

the European Commission. During this action, it collected 59 samples of Halloween and

Carnival costumes. The greatest difficulty encountered related directly to the transitional

period provided for in the legislation. The main difficulty regarded not impeding the making

available on the market of toys which are in accordance with Directive 88/378/EEC and

which were placed on the market before 20 July 2011. However, in Portugal, there are

virtually no toy manufacturers and the number of importers is not significant, and so

inspection actions related to distributors and retailers. The infringements detected related to

the lack of labelling in Portuguese, the absence of a CE marking, noncompliance with

distributor's duties, violation of the requirements relating to the EC declaration, violation of

the rules and conditions on affixing the CE marking and the refusal of economic operators to

submit documentation or information requested by the market-surveillance authority.

Romania

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

1207

1205

2011

1352

1349

2012

1592

1583

2013

1832

1821

597

2010

3.3

4.1

4.2

5.1

5.2

5.3

5.4

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

954

670

1058

1205

2011

2012

2013

1349

1583

1821

1092

817

1286

1256

891

1433

1545

898

1647

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

No information

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

No information

Slovenia

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

n.a.

2011

n.a.

2012

n.a.

2013

n.a.

598

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

2011

1866

468

1374

n.a.

2012

1715

281

1396

n.a.

2013

1540

227

1279

n.a.

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

1905

505

1345

n.a.

1345

1374

1396

1279

303

204

275

231

278

177

264

260

5.4

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

n.a.

Information on communication activities carried out in the 2010-2013 period (optional)

To facilitate the understanding and uniform application of the Directive by manufacturers,

importers and distributors, at the end of 2010 the Slovenian Chamber of Commerce (TZS), in

cooperation with the Ministry of Health, Health Inspectorate and the Institute of Public Health

Maribor, organized an all-day conference "Presentation of innovations in the field Toy Safety

Directive 2009/48/EC and, consequently, the Slovenian legislation". During the presentation

there was also a general discussion with the participants of the conference. In order to

facilitate the monitoring of the changes introduced by the Directive, as part of the obligations

relating to economic operators that operate toys, such as in the field of security requirements,

the Health Inspectorate collected all relevant information on web pages concerning the safety

of toys, and prepared summaries of the most important content relating to the requirements of

the Directive.

The meetings were organized by the Regional Chamber of Craft; we introduced legislation on

the safety of toys.

As the information system does not provide separate information on the number of inspections that result in corrective and

restrictive measures based on the number of administrative (listed in pt. 5.2 and 5.3) and violation of measures (5.4) imposed, the

number of checks which result in corrective and restrictive measures can only be inferred. On the basis of these it can be concluded

that the trader takes the corrective measures identified in the majority of cases of non-compliance before the inspection procedure is

completed, and determining whether further restrictive measures are necessary. The number of inspections that result in non-

compliance being identified (5.1) does not include the identified inconsistencies in sampling activities. Also included in the number

of measures are measures for non-compliant samples.

599

As a result of the European information seminar on the safety of toys in 2012, the Inspectorate

in the field of toys published a translation of frequently asked questions on the website:

http://www.zi.gov.si/si/storitve/gospodarski_subjekti/varnost_igrac/pogosto_zastavljena_vpra

sanja

The website of the Inspectorate includes publicly available information on topical issues (eg.

Used toys, toys sold online, puzzle, amber necklaces ...). The Health Inspectorate's website

http://www.zi.gov.si/si/delovna_podrocja/varnost_igrac

(and links) contains all the

information on the safety of toys aimed at economic operators and consumers.

Information on resources (subject to availability)

2010

7.1

7.2

Budget available to market surveillance

authorities in nominal terms

(€)

Budget available to market surveillance

authorities in relative terms (%age of total

national budget)

Staff available to market surveillance

authorities (full-time equivalent units)

Number of inspectors available to market

surveillance authorities (full-time equivalent

units)

6565372

2011

5813788

2012

5171789

2013

4982892

0.066

0.060

0.057

0.051

135

133

134

129

112

110

109

B. Assessment of the functioning of market surveillance activities in the sector

Inspections on the safety of toys take place in the context of regular and special inspections.

Further monitoring is carried out by sampling. The frequency of periodic audits is determined

on the basis of a risk assessment that takes into account the nature and scope of activities or

facilities that are checked, in relation to the requirements, and changes in regulations and

topical issues, taking into account as well the available resources of the inspectorate. A

special form of emergency controls are those that are carried out where non-compliance has

been identified.

Monitoring also takes place in the context of the various actions which focus on changes each

year depending on the results of the checks in previous years, changes to regulations in the

field of potential new risks and the latest knowledge of the profession. In addition health

inspectors carry out surveillance in kindergartens.

Control of toys that, prior to the enactment of the new Directive were mainly based on the

control of the product, has passed to the control of management of the quality assurance

system of production of toys, and the monitoring of their safety on the market all the way to

the consumer. This approach enables the efficient functioning of market surveillance

authorities.

Overall authority budget.

Number of employees instead of full-time equivalent units.

Total number of inspectors instead of full-time equivalent units.

600

Slovenia has only a small proportion of producers and importers of toys, and therefore the

imposition of the measures in relation to the responsibilities of distributors rather limited. In

the case of unsafe products information on the RAPEX system is provided, but no feedback

on the results of the control of the manufacturers / importers in countries where these

companies have their headquarters.

Slovak Republic

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

909

n.a.

547

n.a.

846

n.a.

255

1682

113

1623

140

1211

129

915

1937

996

941

n.a.

2011

1736

1084

652

n.a.

2012

107

1351

923

399

2013

1044

720

312

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

601

Information on communication activities carried out in the 2010-2013 period (optional)

Trade Inspectorate activities in the field of information and other communication activities are

described in the report on the evaluation of the application of Directive 2009/48/EC on toy

safety, prepared and sent, on request, to the European Commission in July 2014.

Information on resources (subject to availability)

2010

7.1

7.2

Budget available to market

authorities in nominal terms

(€)

surveillance

n.a.

2011

n.a.

2012

n.a.

2013

n.a.

Budget available to market surveillance

authorities in relative terms (%age of total

national budget)

Staff available to market surveillance

authorities (full-time equivalent units )

Number of inspectors available to market

surveillance authorities (full-time equivalent

units )

n.a.

B. Assessment of the functioning of market surveillance activities in the sector

The Trade Inspectorate is Slovakia’s only surveillance authority for toys. Inspections are

conducted to a high standard. The Trade Inspectorate systematically and annually organises

nationwide inspection actions and periodic sampling to verify safety. As there are only a few

small toy manufacturers (wooden and fabric toys) in Slovakia, inspections focus mainly on

distributors and importers from third countries. Inspections mainly centre on economic

operators of Chinese origin established in Slovakia. Particulars concerning inspections (set

out in more detail), and related surveillance problems faced by the Trade Inspectorate, are

described in the report on the evaluation of the application of Directive 2009/48/EC on toy

safety, prepared and sent, on request, to the European Commission.

Finland

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

2011

2012

2013

602

2010

Number of inspections (total number)

1507

792 (T)

715 (C)

3.1

3.2

3.3

4.1

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

706

26 (T)

680 (C)

4.2

physical checks of products

1 (T)

35 (C)

5.1

Number of inspections resulting in:

finding of non-compliance

229

29 (T)

200 (C)

5.2

5.3

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

28 (T)

160

1 (T)

159 (C)

5.4

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

43 (T)

34 (T)

2011

1351

698 (T)

653 (C)

19 (T)

26 (T)

2012

1739

906 (T)

833 (C)

43 (T)

30 (T)

2013

808

81 (T)

727 (C)

49 (T)

41 (T)

636

29 (T)

607 (C)

1 (T)

46 (C)

777

28 (T)

749 (C)

808

41 (T)

672 (C)

84 (C)

5 (T)

55 (C)

190

10 (T)

180 (C)

8 (T)

138

2 (T)

136 (C)

203

26 (T)

177 (C)

25 (T)

1 (T)

72 (C)

189

25 (T)

164 (C)

18 (T)

109

7 (T)

102 (C)

Information on communication activities carried out in the 2010-2013 period (optional)

Tukes gives press releases and publishes the results of market surveillance activities and other

remarks it has made while carrying out market surveillance. During 2010-2013, a total of 9

press releases (1-3 each year) were published based on the Toy Safety Directive.

Tukes also informs consumers, businesses and other stakeholders about changes in legislation

or safety requirements. When necessary, training and lectures are provided for associations,

schools and other stakeholders.

603

Tukes also gives guidance to consumers, businesses, and other stakeholders by answering

their questions via phone and email. Tukes is also active in the social media and uses its

channels to spread information on dangerous products, risks, project results and other issues.

Tukes constantly looks for new ways to inform the public and the stakeholders about safety

issues.

Information on resources (subject to availability)

2010

7.1

Budget available to market surveillance

authorities in nominal terms

(€)

780000

230000 (T)

550000 (C)

7.2

Budget available to market surveillance

authorities in relative terms (%age of total

national budget)

Staff available to market surveillance

authorities (full-time equivalent units )

0.002

3 (T)

10 (C)

Number of inspectors available to market

surveillance authorities (full-time equivalent

units )

2 (T)

10 (C)

2011

780000

230000 (T)

550000 (C)

0.002

3 (T)

10 (C)

2 (T)

10 (C)

2012

780000

230000 (T)

550000 (C)

0.001

3 (T)

10 (C)

2 (T)

10 (C)

2013

780000

230000 (T)

550000 (C)

0.001

3 (T)

10 (C)

2 (T)

10 (C)

B. Assessment of the functioning of market surveillance activities in the sector

Market surveillance programs have been carried out as planned. Programs include 1-3 current

projects (topics vary yearly). Despite the relatively small resources Tukes has been effective,

and 38 recalls and 20 withdrawals have been done during 2010-2013.

Sweden

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

604

2010

3.1

3.2

3.3

4.1

4.2

5.1

5.2

5.3

5.4

Number of product related accidents / user

complaints

Number of substantiated complaints by industry

concerning unfair competition

Number of inspections (total number)

number of reactive inspections

number of self-initiated inspections

number of inspections prompted by the customs

Number of inspections based on:

tests performed in laboratories

physical checks of products

Number of inspections resulting in:

finding of non-compliance

corrective actions taken by economic operators

(“voluntary measures”)

restrictive measures

surveillance authorities

taken

market

2011

2012

2013

117

130

113

124

application of sanctions/penalties

Number of inspections where other Member

States were invited to collaborate

Information on communication activities carried out in the 2010-2013 period (optional)

In 2012 and 2013, the three market surveillance authorities in Sweden, the Swedish Consumer

Agency, Kemikalieinspektionen [the Swedish Chemicals Agency] and the National Electrical

Safety Board cooperated on a joint project. In the joint authority project in 2012-2013,

contacts were built up with the Swedish trade associations, Barn och baby [Children and

Baby], PUFF (Företagare-Föreningen för grossister och tillverkare inom present-, interiör-

och designbranschen) [Company Owners-Association of wholesalers and manufacturers of

gift, interior and design products) and Svensk dagligvaruhandel [the Association of Swedish

Grocery Retailers]. The Swedish Consumer Agency has an established collaboration with

Leksaksbranschen [the Swedish Toy Association]. These industry associations have helped to

disseminate information on training courses, market surveillance and other information that

the authorities wished to issue. During the joint authority project, there has also been closer

cooperation with the Swedish Toy Association, since they have acted as a sounding board for

the development of information material.

605

Through the training courses held within the framework of the joint authority project, an e-

mail list was built up with over 100 recipients wishing to have information on toy safety from

the authorities. The authorities did not obtain all these recipients via the industry associations.

Other interested parties have also taken part in the training sessions for the industry such as

SIS [the Swedish Standards Institute], Swerea IVF, the IKEM [Innovation and Chemical

Industries in Sweden] industry association (formerly the Swedish Plastics and Chemicals

Federation), Leksaksbranschen [the Swedish Toy Association], Naturvårdsverket [the

Swedish Environmental Protection Agency] and Läkemedelsverket [the Swedish Medical

Products Agency].

The Swedish Consumer Agency has deliberately prioritised work on information for

economic operators for the 2011-2014 period, and for that reason no general information

campaign aimed at consumers has been conducted. Nevertheless, a training course on the

dangers of magnets in toys was carried out for consumer guidance in 2012. This took place in

advance of market surveillance of magnets in toys and other products.

The Swedish Consumer Agency and the Swedish Chemicals Agency presented a paper, along

with other authorities, at a European Commission information campaign organised by TIE

and the Swedish Toy Association in Malmö in 2012.

In 2012 and 2013, the three market surveillance authorities in Sweden cooperated on a joint

project.

The joint authority project in the 2012-2013 period included a sub-project on proactive work.

In this sub-project, the three authorities reviewed their information on each authority's

website. The Swedish Chemicals Agency has developed a new website that deals with

legislation relating to toys in various ways. The Swedish Consumer Agency has also produced

new pages on its website in order to clarify the information on the new legislation. The

National Electrical Safety Board also has a site describing its procedures on toy supervision.

These three websites link to one another in the hope that this will make it easier for companies

to search for information on toy safety regulations. During the course of the project, the

Swedish Consumer Agency's website on toy safety was visited 6887 times (unique page

views).

Printed information material aimed at companies has also been produced. This material

clarifies companies' responsibilities as regards toy safety according to their role in the supply

chain. The material is entitled "Ansvarsroller för leksakers säkerhet" [Roles and

responsibilities for toy safety] and consists of a playing card and three leaflets. The card is

intended to help determine a company's roles and responsibilities according to the

circumstances for each toy. The card contains a question on one side, for example: "What is

my role if I buy toys from a company in Sweden or another EU country?" The other side of

the card contains the answer: "Distributor". When the company's role for the toy in question

has been determined using the guide on the playing card, more information on the

responsibilities deriving from that role can be obtained from one of the three leaflets. The

three brochures provide information on the responsibilities of manufacturers, importers and

distributors and summarise the requirements established for each role. The information

material is available in printed format from the three authorities, but can also be downloaded

from the Swedish Consumer Agency's website.

During the work on the project, companies requested more information from the authorities,

including a checklist of the rules applying to a toy. On the basis of those requests, the

606

authorities produced joint information material entitled "Är leksaken säker?" [Is the toy safe?]

The material is largely based on a "mind-map" and highlights the different regulations with

which a toy must comply. The information material is available for download from the

Swedish Consumer Agency's website.

During year two of the project, what was, for the authorities, a new way of working with

information was used. The three authorities produced a joint information letter about the new

rules on toy safety. The letter contained some basic information on requirements for toys and

market surveillance, as well as information on market surveillance to be carried out in 2013.

The information letter was sent to approximately 300 companies identified as toy dealers

using the authorities' own records and import statistics on toys from Swedish Customs. The

letter was distributed to members of five industry associations: the Swedish Toy Association,

Children and Baby, the Association of Swedish Grocery Retailers, the Swedish Trade

Federation and PUFF (Company Owners-Association of wholesalers and manufacturers of

gift, interior and design products).

Two training sessions for companies and other operators in the toy industry were organised in

the project in collaboration with the industry association the Swedish Toy Association. One

occasion in autumn 2012, when the training course had a duration of three days, and one

occasion in spring 2013, when the training course had a duration of one and a half days. After

the end of the project (May 2014) a further training session of one and a half days was

arranged jointly by the authorities and the Swedish Toy Association. Training consisted of

presentations on the new rules on toy safety and market surveillance carried out by the three

market surveillance authorities for toys. The Swedish Medical Products Agency, the Swedish

Environmental Protection Agency, SIS (the Swedish Standards Institute), Swerea IVF, the

IKEM [Innovation and Chemical Industries in Sweden] industry association (formerly the

Swedish Plastics and Chemicals Federation) also took part. The industry also participated

with presenters describing how to work with the requirements in practice. Time at the training

sessions was also set aside for questions. The companies were able to give notice of questions

in advance. The training materials entitled "Roles and responsibilities for toy safety" and "Is

the toy safe?" were distributed to the companies along with additional information material on

the EC declaration of conformity and labelling of toys, the requirements regarding chemicals

and the Commission's brochure on the Toy Safety Directive. Participation in the training

sessions was high, with 80-100 persons per session on the seven training days. The feedback

received from the participating companies showed that they considered the training sessions

to be good and they requested [...] In order to compile information from the training sessions

for the companies taking part and to enable information from the training sessions to be

distributed to more companies, special websites were created after the various training

sessions where presentations from the training session, as well as questions and answers from

the question and answer session, were published.

Links to the training session websites were also posted on the Swedish Consumer Agency

website.

The addresses for these websites are:

http://www.eko.kov.se/Leksakerssakerhet/,

http://www.eko.kov.se/Leksakerssakerhet2013/

and

607

http://www.leksaksbranschen.se/index.php/om-leksaksbranchen/utbildning-i-

leksakerssakerhet-14-15-maj-2014.Since the Swedish law on toy safety also covers public

activities in Sweden, a letter on the new rules on toy safety was sent to SKL (Sveriges

Kommuner och Landsting

–

the Swedish Association of Local Authorities and Regions). SKL

then produced information for its members, with the support of the Swedish Consumer

Agency.

That information was also submitted to the Commission, within the framework of supervision

of the Directive, in a separate report on the application of the Toy Safety Directive.

Information on resources (subject to availability)

2010

7.1

7.2

Budget available to market surveillance

authorities in nominal terms

(€)

Budget available to market surveillance

authorities in relative terms (%age of total

national budget)

Staff available to market surveillance

authorities (full-time equivalent units )

Number of inspectors available to market

surveillance authorities (full-time equivalent

units )

176800

2011

154300

2012

170365

2013

213100

n.a.

2.4

2.0

2.2

2.8

0.3

B. Assessment of the functioning of market surveillance activities in the sector

There are toys on the Swedish market that do not comply with the applicable safety

requirements for toys. Continued market surveillance of toy safety is therefore necessary, both

to remove dangerous toys from the market and to disseminate information to companies.

The total value of toys supplied to the Swedish market each year is around 4 billion Swedish

kronor. It is estimated that 300 companies import toys to Sweden. It is estimated that there are

200 manufacturers. The number of operators other than manufacturers can be roughly

estimated at over 400. It is difficult to estimate the number of outlets for toys on the market,

but there are probably more than 10 000. In addition, there are on-line operators that are not

registered in Sweden.

Most toys are manufactured in Asia. During visits to companies it was found that a common

way to buy toys is via trading houses or "traders", who in turn have contacts with various

factories. Therefore, those purchasing through a trading house or a trader often do not come

into direct contact with the manufacturer. This can make the establishment of requirements

and communication between the customer and the manufacturer more difficult.

Purchasing via a trading house should not constitute an obstacle to supplying only safe toys.

The economic operators have a great responsibility for checking the toys delivered to them

and to require that the toys should comply with applicable requirements. It was revealed

during visits to companies that several companies have a poor knowledge of the rules on toys,

and this naturally makes it more difficult for them to impose requirements on the suppliers.

608

Nor were many companies aware of their responsibilities according to whether they have

manufactured, imported or purchased the toy on the internal market. They were aware that

there are differences in terms of responsibility and they considered that the manufacturer

should have the greatest responsibility. Having greater knowledge of their own and other

operators' responsibility in the supply chain should make it easier for requirements to be

imposed between operators.

Toys are heavily regulated products. With the large number of rules applying to toys, there

should be a system at each company for imposing requirements on and communicating with

suppliers. Many companies lack such a system.

United Kingdom

A. Review of market surveillance activities in the sector

Information on enforcement activities carried out in the 2010-2013 period

2010

10.

Number of inspections

Number of inspections concerning products sold

over the internet

Number of products inspected

Number of products tested in labs

Number of non-compliant products found on the

market

Number of dangerous products posing a serious

risk

Number of administrative decisions taken

Number of products withdrawn from the market

Number of products recalled from the market

Number of decisions taken by authorities in

charge of external border controls to suspend

products at the border

Number of decisions to reject products at the

border

Number of products destroyed

Number of voluntary measures taken by

companies

Number of voluntary withdrawals

827

347

135

451

2011

1665

45517

696

2195

353

561

690

2012

1299

8806

570

955

149

160

2013

11.

12.

13.

14.

609

2010

15.

16.

17.

Number of voluntary recalls

Number of sanctions imposed

Number of total pieces of advice offered to all

in supply chain

2011

2012

335

2013

Information on communication activities carried out in the 2010-2013 period (optional)

No information

Information on resources (subject to availability)

No information

B. Assessment of the functioning of market surveillance activities in the sector

Trading Standards are part of Local Authorities, of which there are over 200 in the UK. Each

local authority acted independently setting its own priorities. The “Home Authority”

principle

operates among local authorities.

The Home/Lead Authority Partnerships helped councils to work together effectively and

avoid duplication of effort when regulating businesses who trade across local council

boundaries, and support them by providing contact points for advice and guidance in order to

maintain high standards of public protection and develop a consistent approach to

enforcement. Further details of Trading Standards market surveillance activities have been

described in this document.

In relation to the Toy Safety Directives, the UK provided two reports to the European

Commission in 2014 which gave accounts of how they applied the Directives. The two

reports were the Questionnaire on the Application of Article 51 of the Directive and on its

application.

BIS are encouraging authorities to look at more ambitious strategic projects and projects

which involve authorities working in partnership to deliver the outputs. Project proposals

should be for products which have been placed on the market i.e. not products intercepted at

ports. As before, there is separate funding for testing products at ports via the National

Trading Standards Board (NTSB). BIS requires in return a report covering the activities and

the analysis of the outcomes. BIS will expect the outputs from successful projects to be made

available for all UK Trading Standards Departments via the NTSB Information Hub and other

interested bodies.

BIS is also continuously reviewing the UK market surveillance structure with its relevant

stakeholders and MSAs. From a workshop organised by BIS earlier in 2014 with these bodies,

BIS asked representatives of UK MSAs for their views such as improving enforcement, more

effective communication, funding and training. The workshop informed a follow-up exercise

where a questionnaire, based on break-out session outcomes, was sent to those who attended.

The outputs from these activities have now been summarised by BIS with priority actions

identified on how BIS will work together with UK MSAs to improve

how the UK’s market

610

surveillance regime operates. In late 2014, BIS commenced an independent review of the

UK’s consumer

product recall system and will expect a report to be with BIS Ministers in

autumn 2015.

611

NNEX

8: B

ACKGROUND

INFORMATION ON COOPERATION AMONG

RESOURCES AVAILABLE FOR CONTROLS OF PRODUCTS

EMBER

TATES

AND

OORDINATION

(

BASELINE

)

OF ENFORCEMENT OF PRODUCT LEGISLATION WITHIN THE

The current section provides a short recollection of main legal, technical, administrative and

financial tools currently available to optimise

cross-border cooperation and work sharing

among authorities.

1.1

ICSMS

ICSMS (Information and Communication System for Market Surveillance) is the database for

information concerning product compliance (ICSMS) referred to in Article 23 of Regulation

(EC) No 765/2008 The Commission carries out continuous activities to facilitate the take up

of the ICSMS system among authorities by means of trainings, the development of user

guides and discussion in regular experts' groups meetings. More than 7 000 products are

encoded in the system every year. In 2015 the database contained information on around

70 000 products and more than 250 000 files stored (i.e.: test lab reports, DoC, pictures, etc.).

The Commission also examined the possibility to converge ICSMS and RAPEX (see below)

into a single platform.

However, Member States use the system to different degrees, as shown in the diagrams below

which show the numbers of product information input to the ICSMS system during 2016.

Clearly the system is not used very well by many market surveillance authorities and some are

not using the system at all. Even within member states, such as the UK and Germany, there is

a great variance between different market surveillance authorities on their use of the system.

Use of ICSMS by all EU/EEA Member States in 2016 (2 with no entries)

612

Use of ICSMS by EU/EEA Member States excluding Germany in 2016

Use of ICSMS for EMC 2004 by all EU/EEA Member States in 2016 (15 with no entries)

Use of ICSMS for EMC 2004 by EU/EEA Member States excluding Germany in 2016

613

Use of ICSMS for EMC 2014 by all EU/EEA Member States in 2016 (25 with no entries)

Use of ICSMS for EMC 2014 by EU/EEA Member States excluding Germany in 2016

Use of ICSMS for Machinery by all EU/EEA Member States in 2016 (13 with no entries)

614

Use of ICSMS for Machinery by EU/EEA Member States excluding Germany in 2016

Use of ICSMS for LVD 2014 by all EU/EEA Member States in 2016 (21 with no entries)

Use of ICSMS for LVD 2014 by EU/EEA Member States excluding Germany in 2016

615

Use of ICSMS for LVD 2006 by all EU/EEA Member States in 2016 (11 with no entries)

Use of ICSMS for LVD 2006 by EU/EEA Member States excluding Germany in 2016

Use of ICSMS for GPSD by all EU/EEA Member States in 2016 (14 with no entries)

616

Use of ICSMS for GPSD by EU/EEA Member States excluding Germany in 2016

1.2

Official notification of measures to other Member States

EU product legislation set out an obligation for Member States' competent authorities to

communicate to the other Member States restrictive measures taken against non-compliant

products. Furthermore, receiving Member States then have an obligation to 'follow up' on

those notifications, i.e. adopt in turn appropriate measures in respect of their national territory.

In many cases they also have the possibility to object to the measures notified and in this case

the Commission will assess whether it was justified

. Recent guidance discussed at expert's

working group level clarifies principles for cooperation based on the existing legal

framework

. It also stresses the importance of this transmission mechanism to make sure that

in relation to products available in various countries non-compliance found by a single

authority could turn into effective corrective action across the whole Single Market.

However, with the exception of few sectors (notably low voltage equipment) only few

notifications of restrictive measures are actually officially sent by national market surveillance

authorities. Furthermore, even in these 'best case scenarios' sectors many Member States do

not actually notify any measures and the number of notifications is decreasing overtime, as

illustrated by the following figure.

The possibility of objections is set out in sector-specific legislation aligned to the reference provisions of Decision No 768/2008/EC

of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing

Council Decision 93/465/EEC.

Guidance on cross-border cooperation among EU market surveillance authorities

(http://ec.europa.eu/DocsRoom/documents/17108/attachments/1/translations).

617

Notifications

Country

Number

Croatia

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Iceland

Ireland

Italy

Latvia

Liechtenstein

Lithuania

Luxembourg

Malta

Netherlands

Norway

Poland

Portugal

Romania

Slovakia

Slovenia

117

109

135

208

238

Percentage

0.34%

5.62%

5.24%

1.30%

1.01%

2.50%

6.48%

9.99%

0.67%

11.43%

0.67%

0.24%

2.69%

2.88%

0.00%

3.55%

0.43%

1.20%

2.98%

0.72%

0.91%

2.02%

1.20%

3.55%

1.01%

Reactions

Number

138

209

179

105

108

106

203

186

153

132

Percentage

5.03%

0.62%

0.66%

7.61%

1.17%

6.52%

3.83%

3.10%

3.93%

2.04%

0.95%

3.86%

0.87%

0.55%

0.00%

0.91%

0.40%

1.09%

7.40%

6.78%

0.11%

5.57%

0.36%

3.24%

4.81%

619

Notifications

Country

Number

Spain

Sweden

United Kingdom

Average

Total

239

162

2082

Percentage

11.48%

3.75%

7.78%

100,00%

Reactions

Number

319

181

111

2745

Percentage

11.62%

6.59%

4.04%

100,00%

Source: Rapid Alert System 2015 results

(http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pa

ges/rapex/reports/index_en.htm)

While progress was achieved in the legal framework and the actual practice concerning the

notification of measures among authorities, there is a feeling that a more systematic follow up

of measures notified by other Member States should be achieved. When asked how often

authorities measure to restrict the marketing of products are adopted following the exchange

of information a good 30% of authorities responding to the consultation still replied this

happens 'rarely' or 'never' or declared 'no experience' (see Figure 8-2).

Figure 8-2: In your experience or knowledge in the relevant product category(-ies) how

often do national authorities restrict the marketing of a product following the exchange

of information about measures adopted by another authority in the EU against the same

product?

11%

Always

17%

19%

Very often

Sometimes

20%

Rarely

Never

30%

No opinion / no experience

1.3

Mutual assistance between Member States' authorities

The current legal framework

101

makes possible mutual assistance among authorities in

different Member States to supply each other with information or documentation and to carry

out appropriate investigations or any other measure

The relevant provision does not provide

101

Article 24 of Regulation (EC) No 765/2008.

620

any detail on the procedure (e.g. the means to be used, the language, the time to reply, etc.) to

be followed to request and grant such assistance. Some guidance was recently developed on

the applicable principles

Although no structured information on requests for mutual assistance exists, informal

feedback from national authorities experts involved in Administrative Cooperation Groups–

see following section

–

indicate this happens only occasionally. Authorities able to produce

figures mentioned in general less than 10 cases per year. An exception seems to be

represented by the sector of medical devices where specific procedures have been gradually

established and on average several

102

requests of mutual assistance are made annually. In the

majority of cases, information on the use of the mutual assistance principle confirms a general

tendency among authorities to focus their action exclusively on correcting non-compliance in

the national territory.

According to information in their 2010-2013 reports on market surveillance

103

, the practice of

collaborating in inspections initiated by a specific Member States is virtually non-existent in

most sectors. In the areas of cosmetics, machinery, electrical, electronic and radio equipment

it is not completely absent but definitely still at an embryonic stage.

1.4

Administrative Cooperation Groups (AdCos)

In many sectors, cooperation between national administrations takes place in working groups

set up under the Union harmonisation legislation. Discussions mainly focus on interpretation

issues, but questions related to market surveillance and administrative cooperation are also

dealt with.

The Expert Group on Internal Market for Products (IMP-MSG) deals with general policy

questions related to the implementation and enforcement of Union harmonisation legislation

at 'horizontal' level, i.e. without addressing issues arising in the particular sectors.

Cooperation between national administrations competent for carrying out market surveillance

in specific sectors takes place by means of the so-called Administrative Cooperation groups

(AdCos)

104

. It concerns a number of sectors.

105

AdCos participants discuss several issues

related to the market surveillance, elaborate common guidance documents and sometimes

carry out joint enforcement actions. An overview of the most recent concrete outcomes of

common discussion can be found on the AdCo webpage hosted by the European

Commission.

106

Since 2013 the Commission provides logistical and financial support to the organisation of

the groups' meetings. According to the feedback received from AdCo Chairs this support has

proven beneficial to increase and stabilise the rate of participation of national authorities in

102

103

104

105

The figure of 200 requests was mentioned during a meeting with national authorities.

See figures in Annex 7 Section 5.

https://ec.europa.eu/growth/single-market/goods/building-blocks/market-surveillance/organisation/administrative-cooperation-

groups_en

Measuring instruments and non–automatic weighing instruments (WELMEC), low voltage equipment (LVD ADCO), Eco-Design

ADCO Group, electromagnetic compatibility (EMC administrative cooperation), civil explosives (CIVEX), machinery, noise

emissions by outdoor equipment (NOISE), medical devices (Vigilance Working Group and COEN

–

Compliance and Enforcement

Group), construction products (CPR), PEMSAC (The Platform of European Market Surveillance Authorities for Cosmetics), Toy-

ADCO (The Administrative Cooperation Group of toys), recreational craft (RCD), personal protective equipment (PPE), equipment

for use in explosive atmospheres (ATEX), Radio and Telecommunications Terminal Equipment (RED), Cableways (CABLE),

Energy Labelling and Eco-design (ENERLAB/ECOD), Gas Appliances (GAD), Lifts (LIFT), Marine Equipment (MED), Pressure

equipment sector (PED/SVPD), Pyrotechnics (PYROTEC), Chemicals (REACH), Restriction of the use of certain hazardous

substances (ROHS), Transportable Pressure Equipment (TPED), Labelling of tyres.

http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=2798

106

621

the meetings. However not all Member states participate in administrative cooperation.

During the 2014-2016 period for most AdCos (ATEX, CPR, EMC, LVD, MACHINE, PPE,

PYROTECH, RCD, TOYS, WELMEC) about two thirds of Member States did take part in

meetings (with a peak of 80% participation rate for the radio equipment group); however in

others (GAD, LIFT, PED) only about 50% Member States participated in the meetings and in

the case of CABLE, NOISE and TPED only about 30-40% of Member States were involved.

Details on Member States participation are illustrated in Table 8-2. Furthermore, according to

the feedback received by AdCo Chairs many representatives of the Member States

participating in the meetings do not get actively involved in common discussions and

activities.

As regards the chemical sector a role analogous to that of the AdCos is played by the Forum

of the ECHA authority (https://echa.europa.eu/about-us/who-we-are/enforcement-forum). In

this case the Forum is a body of ECHA and some ECHA fulfil the role of secretariat for the

Forum. The participation of Member States in the meetings of the Forum is very high (90%).

Table 8-2: Data on participation in AdCos meetings

2014

AdCo

Represented

countries

MSs Other Total

ATEX

CABLE

CIVEX

COEN

CPR

EMC

ENERLAB /

ECOD

GAD

LIFT

no data for 2014

2015

Represented

countries

MSs Other Total

2016 (1

semester)

Represented

countries

MSs Other Total

Partici-

pants

Partici-

pants

Partici-

pants

no data for 2014

October/November

no data for 2016

no data for 2015

622

LVD

MACHINE

NOISE

PED

PPE

PYROTEC

RCD

RED

Meeting October 2016

TOYS

no data for 2014

TPED

WELMEC

no data for 2014

As regards the development of common market surveillance projects, the following table

summarises the joint actions carried out or launched within different AdCos during the 2013-

2016 period and number of countries participating in the action

623

Table 8-3: Joint actions organised within AdCos and number of Member States (MS)

participating

107

AdCo

105

ATEX

CABLE

CIVEX

Information and

instructions on

reprocessable

products (12 MS)

2012-2013: EPS

(10 MS)

ECOD: Lighting

and chain lighting

(10 MS)

ROHS: Toys (8

MS) and Kitchen

appliances (10 MS)

Switching power

supplies (19 MS)

Solar inverters (14

MS)

Gas appliances (8

MS)

Smoke alarms (10

MS)

ROHS: Cheap

products (10 MS)

Windows (7 MS)

ROHS:

Cables/USB/others

(6 MS)

ECOD: Defeat

devices (4 MS)

ENERLAB:

Collecting

inspection data

methodologies (6

MS)

Clinical data (7-8)

Harmonising

inspections (7-8

MS)

2013

2014

2015

2016

COEN

CPR

ECOD /

ENERLAB /

ROHS

EMC

GAD

LIFT

LED

LVD

Floodlights* (13

MS)

2012-2013: Log

Splitters (about 8

MS)

MACHINE

108

2012-2015:

Firewood

Processors (about

7-8 MS)

2011-2015: Impact

Post Drivers (3-4

MS)

Boom saws (3 MS)

Portable chain-

saws and vehicle

servicing lifts* (9-

10 MS)

107

108

Most joint actions are indicated under the year during which they were launched, although projects lasted two or more years.

Joint actions organised in previous periods were: NOMAD Survey of machinery instructions on noise information and noise

declarations (original survey work 2007-2012) about 10 Member States participating; Pinspotters/Pinsetters (machines in 10 pin

bowling alleys), mostly between 2008 and 2012, about 5 Member States participating; Skid-steer Loaders, 2010-2012, 2-3 Member

States; Scissor Lifts, 2010-2012, 5-6 Member States; Wind Turbine access (provision of lifts in towers), 2010-2012, about 4-5

Member States.

624

NOISE

Air receivers for

compressors (2

MS)

PED

PPE

PYROTEC

REACH

1 big action/year involving all Member States. Additional pilot actions on a smaller

scale

Mobile phone

repeaters (14 MS)

Drones (18 MS)

Small inflatable

crafts (6 MS)

RED

RCD

TOYS

TPED

WELMEC WG5

Electric energy

meters* (11)

Heat meters* (10)

* project co-financed by the European Commission.

1.5

Joint actions co-financed by the European Commission

As mentioned in the point above ADCO sometimes organise joint market surveillance

campaigns; in a few cases those actions have been financed by the European Commission on

the basis of financing provisions included in the current legal framework

109

. In particular, the

following calls for proposals were made since 2013:



In 2013 the Commission launched the first call for proposals for joint enforcement

actions under the multi-annual plan for market surveillance of products in the EU. The

grant was awarded to project focussed specifically on active electrical energy meters

and heat meters. The grant took the form of a 70% reimbursement by the Commission

of the eligible costs of the action (amount approximately allocated 350 000 EUR) and

was fully managed by Member States. The action was carried out by a consortium of

authorities under the coordination of a Spanish authority.

In 2014 a new call for proposals for joint enforcement actions was launched and led to

funding by the Commission of two proposed actions respectively the field of machinery

safety and LED floodlights. The grants that have been awarded are in the form an 80%

reimbursement by the Commission of the eligible costs of the actions (total amount

allocated is approximately 1000 000 EUR). One of the actions was coordinated by a

Finish authority, while the other was coordinated by the private company "Prosafe"

110

In July 2015 a call for proposals was launched with a maximum budget foreseen for EU

financing of 500 000 EUR. One proposal was received by the deadline of 1 October

Chapter V of Regulation (EC) No 765/2008.

http://www.prosafe.org/about-us/contentall-comcontent-views/what-is-prosafe



109

110

625



2015 but did not lead to the award of any grant since the proposal received did not

address the objectives as stipulated in the call.

In March 2016 a call for proposals was launched with a higher maximum budget

foreseen for EU financing of 750 000 EUR to maximum 3 projects coupled with a

maximum EU financing rate of eligible costs of up to 80% of the action for joint actions

involving bodies from 10 or more EU-EEA Member States, and 50% involving bodies

from less than 10 EU-EEA Member States. No proposal was received by the deadline of

9 June of this year.

In July 2016 a further call for proposals was launched. The maximum budget of 540

000 EUR was set with maximum financing rates of 95% and 80% respectively. For this

call no proposal was received by the deadline for submission of 30 September 2016.



When discussing with market surveillance authorities the reasons why three calls for

proposals went void why authorities do complain about limited resources, authorities stressed

they welcomed the principle of joint actions financed through grants, and also their outcomes.

However they pointed out the administrative complexity of managing these projects (e.g.

heavy administrative requirements, problems in coordinating work by partners in other

Member State authorities, and taking financial commitments on their behalf). They pointed

out that the Commission should offer an administrative framework for the management of

these actions and of the available money - money is not enough if it is not accompanied by

some sort of infrastructure to allow for the management of the project.

111

Furthermore, joint actions are regularly financed by the Commission under the Consumer

Programme

112

. The following table summarises those carried out or launched during the

2013-2016 period. The projects financed under the Consumer Programme have always been

coordinated by Prosafe.

Table 8-4: Joint actions financed under the Consumer Programme

Member

States +

EFTA

countries

Budget

(in M€)

Grant

(70%)

(in M€)

Work-

days

Authorities

Product categories

Food imitation child-

appealing products

Children's Fancy Dresses

(chemicals in textiles)

Laser Pointers

Ladders

Visibility Clothing &

Accessories

Child Care Articles

Fireworks

Battery chargers

Lawnmowers

Nanotechnology and

JA2010

2.03

1.42

3462

JA2011

2.49

1.69

3995

JA2012

111

112

2.14

1.48

3169

http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetailDoc&id=28611&no=1

http://ec.europa.eu/consumers/eu_consumer_policy/financial-programme/index_en.htm

626

Cosmetics

Childcare Articles-

Highchairs,

Cords and Drawstrings,

Ladders,

CO and smoke detectors)

Toys

Children’s Kick Scooters

Childcare Articles-

Cots,

Chemicals risks

Clothing,

Smoke Detectors

Noisy toys

Fireworks

Power tools

CFL and LED Lighting

Childcare Articles - Safety

Barriers

Plasticised Toys

Power Tools

Electrical Appliances (incl.

electric irons)

Child Care Articles-

Soothers and soother-

holders;

Playgrounds

JA2013

2.27

1.59

3664

JA2014

2.87

1.99

4410

JA2015

3.12

2.18

243.35

person /

month

The Commission has also financed the following initiatives under the Horizon2020

programme:



ECOPLIANT

113

–

joint action in the area of ecodesign legislation (many products

covered) running from 2012 to 2015 and involving 10 Member States; cost of the

project: approximately € 2.4 mln; grant by the European Commission: € 1.8 mln under

the Intelligent Energy Europe program.

EEPLIANT

114

–

joint action in the area of ecodesign and energy labelling (heaters, LED

lamps, printers): 2015-2017, 13 authorities from 12 MS- cost of the project:

approximately € 2.5 mln entirely funded by the European Commission

under the

Horizon 2020 programme.

INTAS (ecodesign, power transformers and large fans): 2016-2019, not a traditional

joint action as about half of the 12 participants are not surveillance authorities, but

energy agencies, research institutes, consultancies and civil society organisations cost of

the project: approximately € 1.9 mln entirely funded by the European Commission

under the Horizon 2020 programme.



113

114

http://www.ecopliant.eu/wp-content/uploads/2012/10/Final-Publishable-Report.pdf

http://www.eepliant.eu

627



MsTyr15

115

joint action concerning tyre labelling launched in March 2016 (until

February 2018) with 13 MS plus Turkey-

cost of the project: approximately € 2 mln

entirely funded by the European Commission under the Horizon 2020 programme.

The ECOPLIANT was successfully coordinated by a UK authority, however it revealed an

important administrative burden for them. For the EEPLIANT and Ms Tyr15 projects the

coordination was ensured by Prosafe. INTAS which does not constitute an enforcement

activity is coordinated by an organisation with experience in managing projects from EU

funds.

1.6

Views of market surveillance experts on cross-border cooperation

In the context of the consultation of market surveillance experts carried out within the IMP-

MSG expert group prior to the 1 February 2016 meeting Member States expressed their views

on the problems affecting cross-border cooperation and the possible solutions. The following

excerpt is taken out of document 2016-IMP-MSG-07rev01 (section 4.3.3) summarising the

results of this consultation:

[Member State A] underlines the need for consistent implementation of the

guidelines on

cross-border

–

cooperation

, complemented if necessary by the set-up of additional legal

arrangements. Furthermore, under the

safeguard clause procedure

all European market

surveillance authorities must take, where necessary, measures to enforce requirements under

European law. [Member State A] also suggests that where a public authority prohibits the

making available on the national market, this should

automatically apply in all MS,

with the

ECJ possibly acting as appeal. Member States should reflect on the possibility of

specialising

in specific fields

. In order to achieve an effective market surveillance system, the adaptation

national legislation

to the EU legislation will be necessary in a number of areas (cross-

border cooperation, mutual recognition of activities of the market surveillance authorities of

other Member States - for example, recognition of test reports, etc.). The

organisation

market surveillance

at national level

should be reconsidered in order to reduce the

fragmentation of responsibilities.

[Member State B] stresses the need for

guidance on cross-border cooperation

to improve

and optimize the results of authorities’ actions. Acco

rding to [Member State B], to achieve

better results in trans-border cooperation between the Member States, in cases of non

–

compliant products a

contact points list for each product group

should be prepared which

could provide fast and easily accessible communication.

According to [Member State C], a

mandatory harmonized procedure for MSA cooperation

will facilitate cases of cross-border cooperation and will further harmonize existing market

surveillance approaches. The administrative burden for MSAs of this procedure should

nevertheless be as minimal as possible.

[Member State D] stresses that prior to setting additional requirements for mutual change of

information, the Commission should ensure that all Member States

actively use the present

procedures

and notes that for example EMC and LVD notifications are made by only a few

States.

115

http://www.mstyr15.eu/index.php/en /

628

[Member State E] would find it useful to receive

more feedback on safeguard notifications

In general, more cooperation and exchange of information is needed at EU and

national

level

[Member State F] notes that

'language borders'

are the main obstacle to day-to-day

cooperation among authorities.

RODUCTS IMPORTED FROM THIRD COUNTRIES

(

BASELINE

)

Points of entry to the EU are relevant to stop non-compliant and unsafe products coming in

from third countries. Being the place where all products from third countries have to pass by,

they are the ideal place to stop unsafe and non-compliant products before they are released for

free circulation and subsequently circulate freely within the European Union. Thus, customs

have an important role in supporting market surveillance authorities in carrying out product

safety and compliance controls at the external borders.

The most effective way to avoid making available non-conforming or unsafe goods imported

from third countries in the Union market is to carry out adequate checks during the import

control process. This requires involvement of customs and cooperation between customs and

market surveillance authorities.

The authorities in charge of the control of products entering the Union market, customs or

market surveillance authorities depending on the national organisational structure, are very

well placed to carry out initial checks, at the first point of entry, on the safety and compliance

of the imported products. There are specific guidelines for import controls in the area of

product safety and compliance. To ensure such controls, the authorities in charge of controls

of products at the external borders need an appropriate technical support in order to carry out

the checks on the characteristics of the products on an adequate scale. They can perform

documentary, physical or laboratory checks. They also need appropriate human and financial

resources.

2.1

The control procedure laid out in Regulation (EC) No 765/2008

Regulation (EC) No 765/2008 on checks for conformity with Union harmonisation legislation

in the case of products imported from third countries requires the customs authorities to be

closely involved in the market surveillance activities and information systems provided for

under EU and national rules. Article 27(2) of Regulation (EC) No 765/2008 foresees the

obligation for cooperation between customs officers and market surveillance officers.

Obligations for cooperation are also included in Article 13 of the Community Customs Code

which establishes that controls performed with customs and other authorities are undertaken

in close cooperation between each other. In addition, the principles of cooperation between

the Member States and the Commission established in Article 24 of the Regulation are

extended to authorities in charge of external controls, when relevant (Article 27(5)).

Cooperation at national level should allow for a common approach taken by customs and

market surveillance authorities during the control process. This should not be hampered by

the fact that various ministries and authorities may be responsible for the implementation of

Regulation (EC) No 765/2008.

Customs authorities have the following responsibilities under Regulation (EC) No 765/2008:

629

–

to suspend the release of products when there is a suspicion that the products present a

serious risk to health, safety, environment or other public interest and/or do not fulfil

documentation and marking requirements and/or the CE marking has been affixed in a

false or misleading manner(Article 27(3)),

not to authorise the release for free circulation for the reasons mentioned in Article 29,

to authorise the release for free circulation for any product in compliance with the

relevant Union harmonisation legislation and/or nor presenting risks to any public

interest,

where the release for free circulation has been suspended, customs have to immediately

notify the competent national market surveillance authority which is given 3 working

days to perform a preliminary investigation of the products and to decide:

if they can be released since they do not present a serious risk to the health and safety or

cannot be regarded as being in breach of Union harmonisation legislation,

if they must be detained since further checks are necessary to ascertain their safety and

conformity.

–

Customs authorities must notify their decisions to suspend release of a product to the market

surveillance authorities, which in turn must be in a position to take appropriate action. Four

hypotheses must be distinguished as from the moment of the notification.

The products in question present a serious risk

If the market surveillance authority ascertains that the products present a serious risk, it

must prohibit their placing on the EU market. The market surveillance authorities have

to request the customs authorities to mark the commercial invoice accompanying the

product, and any other relevant accompanying document, with the words ‘Dangerous

product

—

release for free circulation not authorised

— Regulation (EC) No 765/2008’.

Member State authorities may also decide to destroy the products or otherwise render

them inoperable, where they deem it necessary and proportionate. The market

surveillance authority must use in those cases the system for rapid exchange of

information

—

RAPEX. As a consequence, market surveillance authorities in all

Member States are informed, and they may in turn inform the national customs

authorities about products imported from third countries, which display characteristics

giving rise to a serious doubt as to the existence of a serious risk. This information is of

particular importance for customs authorities where it involves measures banning or

withdrawing from the market products imported from third countries.

Feedback from market surveillance authorities on whether goods are considered as

unsafe or non-compliant is crucial for customs risk management and control processes.

It ensures controls can be concentrated on risky consignments, allowing for the

facilitation of legitimate trade.

Furthermore, when non-compliant or unsafe products are found in the internal market, it

is often extremely difficult to identify how they entered the EU. Cooperation between

customs and market surveillance authorities is encouraged to improve tracing in those

cases.

630

The products in question do not comply with Union harmonisation legislation

In this case the market surveillance authorities must take appropriate measures, if

necessary prohibiting the placing on the market under the rules in question. In cases

where placing on the market is prohibited, they must ask the customs authorities to

mark the commercial invoice accompanying the products, and any other relevant

accompanying document,

with ‘Product not in conformity —

release for free circulation

not authorised

— Regulation (EC) No 765/2008’.

The products in question do not present a serious risk and cannot be considered as not

conforming to the Union harmonisation legislation. In this case the products must be

released for free circulation, provided that all the other conditions and formalities

regarding release for free circulation are met.

The customs authorities have not been notified of any action taken by the market

surveillance authorities.

If, within 3 working days of the suspension of release for free circulation, the market

surveillance authority has not notified customs of any action taken by them, the product

has to be released for free circulation provided that all the other requirements and

formalities pertaining to such release have been fulfilled.

The entire procedure from the suspension until the release for free circulation or its

prohibition by customs should be completed without delay to avoid creating barriers for

legitimate trade but does not necessarily have to be completed within 3 working days.

The suspension of release can remain valid for the time required by the market

surveillance authority to carry out appropriate checks on the products and allow them to

take the final decision. Market surveillance authorities must ensure that the free

movement of products is not restricted to any extent greater than that which is allowed

under Union harmonisation legislation or any other relevant EU legislation. To that end

market surveillance authorities perform their activities regarding products originating

from third countries

—

including the interaction with the relevant economic operators

—

with the same urgency and methodologies as for products originating from within the

EU.

In this case, the market surveillance authority notifies customs within these 3 working

days that their final decision on the goods is pending. The release for free circulation

has to remain suspended until the market surveillance authority has made a final

decision. That notification empowers customs to extend the initial suspension period.

The products will remain under customs supervision even if they are allowed to be

stored at another place approved by customs.

2.2

2.2.1

Cooperation and coordination of action among Customs

Administrative assistance

Customs cooperation based on the UCC enables exchanging information among customs to

ensure correct application of the customs legislation and customs rules as well as creating a

level playing field for business operators.

631

In 2015, almost 2 000 requests for administrative assistance were sent within the EU. There is

an upward trend linked to cooperation in the form of administrative assistance between

individual customs administrations.

2.2.2

The Customs Risk Management Framework (CRMF)

A sophisticated common customs risk management framework (CRMF) had been introduced

into the previous customs legislation and is now covered by Article 46 UCC.

The CRMF is based on the recognition of a need to establish an equivalent level of protection

in customs controls for goods brought into or out of the EU and to ensure a harmonised

application of customs controls by the MS. It aims to support a common approach so that

priorities are set effectively and resources are allocated efficiently with the aim of maintaining

a proper balance between customs controls and the facilitation of legitimate trade.

The CRMF therefore comprises:



the identification and control of high-risk goods movements using

common risk

criteria -

see section 2.2.2.1.;

the identification of

priority control areas

subject to more intense controls for a

specific period;

see section 2.2.2.2.;

systematic and intensive

exchange of risk information

between customs- see section

2.2.2.3.;

the contribution of

Authorised Economic Operators

(AEO) in a customs-trade

partnership to securing and facilitating legitimate trade; and

pre-arrival/pre-departure security risk analysis

based on cargo information

submitted electronically by traders prior to arrival or departure of goods in/from the EU

specifically to cater primarily for security and safety risks.

The common risk criteria and standards

The Commission has adopted a set of criteria to be applied in the Member States' risk analysis

systems in order to continuously screen electronic advance cargo information for security and

safety purposes. The criteria are set out in an implementing act based on the empowerment of

Article 50(1) UCC, which is not public for obvious reasons. The CRC are aimed primarily

towards identifying high-risk consignments/goods that could have serious implications for the

security and safety of the EU and its citizens and providing equivalent protection throughout

the external frontier based on common risk analysis.

While in all other types of movements, the customs office where goods and declaration

are presented is responsible for the processing of the declaration and for the risk analysis,

customs at the first point of EU entry has a legal obligation to carry out the security and

safety risk analysis on all the cargo regardless of the country of EU destination.

Consignments crossing the EU border are thus screened on the basis of those criteria 365

days a year.

632

Priority Control Areas

Priority Control Areas (PCAs) are the key mechanism in the CRMF allowing the Union to

designate specific areas to be treated as a priority for customs control. The identified areas are

subjected to reinforced customs controls carried out in a co-ordinated manner based on

common risk assessment criteria and real-time exchange of risk information.

Priority areas may relate to any customs procedure, types of goods, traffic routes, modes of

transport or economic operators. The chosen areas are to be subject to increased levels of risk

analysis and customs controls for a pre-determined limited period with a start and end date

and possibility for interim review.

Priority control areas have built-in assessment procedures and flexibility for Member States in

order to ensure that the control action to be taken is not disproportionate or unduly disruptive

in terms of the effect on trade flows within a Member State or a particular port or frontier

point.

The exchange of risk information

The Common Customs Risk Management System (CRMS) is designed to provide a fast and

easy-to-use mechanism to distribute and exchange customs control and risk-related

information directly amongst operational officials and risk analysis centres in the 28 Member

States.

It facilitates EU-wide customs intervention for the highest risks at the external frontier and

inland and is thus an integral element in the development of a Union risk management

framework. It consists of a form (Risk Information Form, called RIF) to be filled in on-line

and instantly made available to all customs offices connected.

The RIF is a means of ensuring a consistent level of customs control is applied at the external

frontier of the Union in relation to identified risks thereby offering the necessary level of

protection to citizens and to the financial interests of the EU and MS while ensuring

equivalent treatment of traders throughout the Union.

Authorised Economic Operators

The AEO concept is based on the Customs-to-Business partnership introduced by the World

Customs Organisation (WCO). Traders who voluntarily meet a wide range of criteria work in

close cooperation with customs authorities to assure the common objective of supply chain

security and are entitled to enjoy benefits throughout the EU.

The EU established its AEO concept based on the internationally recognised standards,

creating a legal basis for it in 2008 through the 'security amendments' to the "Community

Customs Code" (CCC) (Regulation

(EC) 648/2005)

and its implementing provisions.

The programme, which aims to enhance international supply chain security and to facilitate

legitimate trade, is open to all supply chain actors. It covers economic operators authorised for

customs simplification (AEOC), security and safety (AEOS) or a combination of the two.

On the basis of Article 39 of the Union Customs Code (UCC), the AEO status can be granted

to any economic operator meeting the following common criteria:

633

Conditions and criteria

Compliance with customs legislation and taxation rules and absence of

criminal offences related to the economic activity.

Appropriate record keeping.

Financial solvency.

Proven practical standards of competence or professional qualifications.

Appropriate security and safety measures.

AEOC

AEOS

The AEO status granted by one Member State is recognised by the customs authorities in all

Member States (Article 38 (4) UCC). The conditions and criteria to grant the status do not

take explicitly into account the economic operators' compliance with EU product

harmonisation legislation.

AEO benefits are an integral part of the EU legislation governing the AEO status. The AEO

benefits, dependent on the type of the authorisation, are summarised in the table below:

Benefit

Easier admittance to customs simplifications

Fewer physical and document-based controls



related to security & safety

related to other customs legislation

AEOC

AEOS

Prior notification in case of selection for physical control (related to safety and

security)

Prior notification in case of selection for customs control (related to other

customs legislation)

Priority treatment if selected for control

Possibility to request a specific place for customs controls

Indirect benefits

(Recognition as a secure and safe business partner, Improved relations with

Customs and other government authorities; Reduced theft and losses; Fewer

delayed shipments; Improved planning; Improved customer service; Improved

customer loyalty; Lower inspection costs of suppliers and increased co-

operation etc.)

Mutual Recognition with third countries

Customs resources

Customs face a significant challenge to manage increasing volumes of goods and tasks while

facing a downward trend in resources

116

. The total number of personnel working in Customs

116

Developing the EU Customs Union and its governance, COM(2016)813 final, 21.12.2016.

634

Administrations in EU was 112.8 thousand at the end of 2015, this is a 10% decline since

2010 and a reduction of 2% in comparison to 2014.

When interpreting these figures, it should be taken into consideration that not all the MS are able to provide the exact data

on the allocation of their staff. This could be due to merged organisations where the customs are mixed together with tax

administrations, etc. In such cases, data was only estimated by the MS.

3. R

ESOURCES AND EXPERTISE OF AUTHORITIES

(

BASELINE

)

EU rules on market surveillance for products contain an obligation for Member States to

entrust market surveillance authorities with the power, resources and knowledge necessary for

the proper performance of their tasks. No definition is provided for the concept of 'proper

performance' of the tasks of market surveillance authorities. The provision does not set out an

obligation to indicate the desirable level of performance or the amount of resources allocated.

Common rules simply specify that authorities' should perform 'checks on the characteristics of

products on an adequate scale'. In order to increase transparency on available resources the

Commission in collaboration with Member States has proposed specific market surveillance

indicators concerning budget and staff and developed methodology to estimate them.

3.1

Information on resources based on national reports for the 2010-2013

The analysis

117

of the information on budget and staff provided by the member states for the

2010- 2013 period allowed the identification of the following findings:



The total

budget available to MSAs

in nominal terms at EU level:

118

Decreased during 2010-2013

(from €133.4 mil. to €123.8 mil.),

It was concentrated in a reduced number of countries and large differences

could be noticed in terms of budget available to each country during the four year-

period;

It represented around 0.1-1.33%

119

out of the total national budget;



A similar evolution was registered by the

human resources.

During the period 2010-

2013 a reduction of FTEs available to MSAs can be registered as well as a

concentration of FTEs on a reduced number of countries;

117

118

119

Source: Final report of the Ex-post evaluation of the application of market surveillance provisions of regulation (EC) No 765/2008.

Not all EU-28 Member States provided reliable data for this indicator. Therefore, figures do not include Austria, Cyprus, Estonia,

Greece, Croatia, Luxembourg, Slovenia, the United Kingdom and Hungary.

The figures refer to 10 countries that provided reliable data, precisely: Denmark, Estonia, Spain, Finland, Italy, Latvia, Malta,

Poland, Sweden and Slovakia.

635



However, the analysis revealed an increasing trend in the

number of inspectors,

though specific interviews are needed to further investigate differences across countries

and to triangulate data.

More details on each of these findings are presented below. Moreover, they should be

considered only preliminary findings that will be further investigated and correlated with

results from other study activities (market analysis and field research).

3.2

Financial resources available for market surveillance activities

As for the

total budget available to MSAs in nominal terms,

the data indicates reduced

annual fluctuations at the EU level, though in a negative direction. The figures refer to 19 out

of 28 EU Member States, as Austria, Cyprus, Estonia, Greece, Croatia, Luxembourg,

Slovenia and United Kingdom have not included this data in their national reports. Moreover,

Hungary has reported values since 2011, therefore it was not considered the lack of data for

2010 would have created a different perspective on the 2010-2013 trends.

Table 8-5:

Budget available to market surveillance authorities in nominal terms (€) for

selected sectors in the 2010-2013 period

Sectors

Number of

Member States

providing

budget

information

Average

amount of

resources per

Member State

and per year

(simple

average)

1,391,889 €

Average

amount of

resources per

1000

inhabitants

(population on 1

January

2015)

120

34.14 €

SECTOR 1 - Medical devices (including in vitro

diagnostic medical devices and active implantable

medical devices)

SECTOR 2 - Cosmetics

SECTOR 3 - Toys

121

122

123

4,993,718 €

1,917,787 €

43.21 €

17.48 €

SECTOR 4 - Personal Protective Equipment

124

270,913€

2.53 €

SECTOR 5 - Construction Products

125

425,273 €

3.39 €

120

121

122

123

124

125

Population on 1 January 2015 as provided by Eurostat

Denmark, Ireland, Cyprus, Latvia, Portugal, Slovenia, Finland and Sweden.

Denmark, France, Hungary, Portugal, Slovenia, Slovak Republic, Finland and Sweden

Bulgaria, Denmark, Ireland, France, Hungary, Slovenia, Finland and Sweden. For Ireland, the budget across is the total NCA budget

for all activities (excluding financial awareness and education), since it is not possible for the authority to identify the specific

amount of the annual budget which is directly related Product Safety Market Surveillance or related activities. For France, the

number provided doesn’t

include the budget for product testing. Slovenia has provided the overall authority budget. Bulgaria

provided the budget for all activities since it is not possible for the authority to identify the specific amount of the annual budget

which is directly related Product Safety Market Surveillance or related activities.

Bulgaria, Denmark, France, Hungary, Slovenia, Finland and Sweden. Bulgaria provided the budget for all activities since it is not

possible for the authority to identify the specific amount of the annual budget which is directly related Product Safety Market

Surveillance or related activities.

Bulgaria, Denmark, France, Cyprus, Hungary, Romania, Finland and Sweden.

636

Sectors

Number of

Member States

providing

budget

information

Average

amount of

resources per

Member State

and per year

(simple

average)

9,635 €

355,540 €

274,912 €

564,028 €

Average

amount of

resources per

1000

inhabitants

(population on 1

January

2015)

120

0.50 €

3.39 €

2.86 €

5.27 €

SECTOR 6 - Aerosol dispensers

SECTOR 7 - Simple pressure vessels and Pressure

Equipment

SECTOR 8 - Transportable pressure equipment

SECTOR 9 - Machinery

126

127

128

129

SECTOR 10 - Lifts

SECTOR 11 - Cableways

SECTOR 12 - Noise emissions for outdoor

equipment

SECTOR 13 - Equipment and Protective Systems

Intended for use in Potentially Explosive

Atmospheres

SECTOR 14 - Pyrotechnics

SECTOR 15 - Explosives for civil uses

SECTOR 16 - Appliances burning gaseous fuels

130

131

132

133

425,111 €

741,722 €

169,647 €

210,451 €

15.08 €

57.67 €

1.94 €

2.04 €

134

135

136

336,074 €

196,517€

186,410 €

3.90 €

2.44 €

1.70 €

126

127

128

129

130

131

132

133

134

135

Bulgaria, Denmark, Cyprus and Finland. Bulgaria provided the budget for all activities since it is not possible for the authority to

identify the specific amount of the annual budget which is directly related Product Safety Market Surveillance or related activities.

Bulgaria, Denmark, France, Hungary, Finland and Sweden. Bulgaria provided the budget for all activities since it is not possible for

the authority to identify the specific amount of the annual budget which is directly related Product Safety Market Surveillance or

related activities.

Bulgaria, Denmark, France, Cyprus, Hungary and Finland. Bulgaria provided the budget for all activities since it is not possible for

the authority to identify the specific amount of the annual budget which is directly related Product Safety Market Surveillance or

related activities.

Bulgaria, Denmark, France, Hungary, Slovenia, Finland and Sweden. Bulgaria provided the budget for all activities since it is not

possible for the authority to identify the specific amount of the annual budget which is directly related Product Safety Market

Surveillance or related activities.

Bulgaria, Denmark, Hungary and Finland. Bulgaria provided the budget for all activities since it is not possible for the authority to

identify the specific amount of the annual budget which is directly related Product Safety Market Surveillance or related activities.

Bulgaria and Denmark. Bulgaria provided the budget for all activities since it is not possible for the authority to identify the specific

amount of the annual budget which is directly related Product Safety Market Surveillance or related activities.

Bulgaria, Italy, Hungary and Sweden. Bulgaria provided the budget for all activities since it is not possible for the authority to

identify the specific amount of the annual budget which is directly related Product Safety Market Surveillance or related activities.

Bulgaria, Denmark, France, Hungary, Finland and Sweden. Bulgaria provided the budget for all activities since it is not possible for

the authority to identify the specific amount of the annual budget which is directly related Product Safety Market Surveillance or

related activities.

Bulgaria, Denmark, France, Cyprus and Finland. Bulgaria provided the budget for all activities since it is not possible for the

authority to identify the specific amount of the annual budget which is directly related Product Safety Market Surveillance or related

activities.

Bulgaria, France, Cyprus and Finland. Bulgaria provided the budget for all activities since it is not possible for the authority to

identify the specific amount of the annual budget which is directly related Product Safety Market Surveillance or related activities.

637

Sectors

Number of

Member States

providing

budget

information

Average

amount of

resources per

Member State

and per year

(simple

average)

316,777€

Average

amount of

resources per

1000

inhabitants

(population on 1

January

2015)

120

2.74 €

SECTOR 17 - Measuring instruments, Non-

automatic weighing instruments and Pre-packaged

products

SECTOR 18 - Electrical equipment under EMC

SECTOR 19 - Radio and telecom equipment under

RTTE

SECTOR 20 - Electrical appliances and equipment

under LVD

SECTOR 21 - Electrical and electronic equipment

under RoHS, WEEE and batteries

SECTOR 22 - Chemicals (Detergents, Paints,

Persistent organic pollutants)

SECTOR 23 - Ecodesign and Energy labelling

SECTOR 24 - Efficiency requirements for hot-

boilers fired with liquid or gaseous fuels

SECTOR 25 - Recreational craft

SECTOR 26 - Marine Equipment

136

137

138

139

140

137

138

139

140

141

142

143

144

145

146

1,213,247 €

1.630.901 €

663,663 €

191,120 €

145,000 €

215,344 €

120,924 € €

284,264 €

75,854 €

5.51 €

7.37

€

5.74 €

5.83 €

1.50 €

1.99 €

2.65 €

2.86

€

2.97 €

141

142

143

144

145

146

Belgium, Bulgaria, Denmark, France, Cyprus, Hungary, Slovenia and Finland. Bulgaria provided the budget for all activities since it

is not possible for the authority to identify the specific amount of the annual budget which is directly related Product Safety Market

Surveillance or related activities.

Bulgaria, Denmark, France, Hungary, the Netherlands, Austria, Slovenia, Finland and Sweden. Bulgaria calculated the budget by

multiplying the number of staff available to market surveillance authorities by the average amount per unit applicable to the year

concerned. France included budget only for pre-packaged products.

Belgium, Bulgaria, Denmark, Germany, France, Cyprus, Hungary, Romania, Slovenia, Finland and Sweden. Bulgaria provided the

budget for all activities since it is not possible for the authority to identify the specific amount of the annual budget which is directly

related Product Safety Market Surveillance or related activities.

Belgium, Bulgaria, Denmark, Germany, Estonia, France, Portugal, Romania, Slovenia, Finland and Sweden. Bulgaria provided the

budget for all activities since it is not possible for the authority to identify the specific amount of the annual budget which is directly

related Product Safety Market Surveillance or related activities.

Belgium, Bulgaria, Denmark, France, Cyprus, Latvia, Hungary, Slovenia, Finland and Sweden. Bulgaria provided the budget for all

activities since it is not possible for the authority to identify the specific amount of the annual budget which is directly related

Product Safety Market Surveillance or related activities. For Slovenia, the number of the budget includes also the costs of laboratory

tests and payment for samples taken, with a corresponding claim from the liable party for the reimbursement of costs in the case of a

compliant product.

Bulgaria, Denmark, Ireland, Hungary and Finland. Bulgaria provided the budget for all activities since it is not possible for the

authority to identify the specific amount of the annual budget which is directly related Product Safety Market Surveillance or related

activities.

Denmark, Ireland, France, Latvia, Hungary, Slovenia and Finland.

Belgium, Bulgaria, Ireland, France, Cyprus, Hungary, Slovenia and Finland. Bulgaria provided the budget for all activities since it is

not possible for the authority to identify the specific amount of the annual budget which is directly related Product Safety Market

Surveillance or related activities.

Belgium, Ireland, Hungary and Romania.

Bulgaria, France, Romania and Finland. Bulgaria provided the budget for all activities since it is not possible for the authority to

identify the specific amount of the annual budget which is directly related Product Safety Market Surveillance or related activities.

Denmark and Romania.

638

for the first indicators, Hungarian authorities have not reported data for 2010, therefore the

country was not included in the analysis.

3.3

Human resources available for market surveillance activities

The

staff available to MSAs (FTE units)

is another indicator relevant for computing the

enforcement costs incurrent by national authorities. The uninterrupted negative trend

registered by the budget available for MSA expressed in nominal terms can be observed also

in this case, potentially as a result of the budget decrease. Consequently, the costs incurred by

the national authorities in their endeavours to enforce the implementation of the Regulation

related to the staff are lower starting in 2013 compared with 2010. Nineteen countries

compliant with the Regulation provision to provide the data for all four years have been

considered in the data processing; Hungary, as stated before, did not provide all necessary

data.

Table 8-6: Staff available to market surveillance authorities for selected sectors in the

2010-2013 period

Sectors

Number of

Member States

providing staff

information

Average

amount of staff

available per

Member State

and per

year(simple

average)

58.60

Average

amount of staff

available per

1000000

inhabitants

(population on

1 January

2015)

155

0.46

SECTOR 1 - Medical devices (including in vitro

diagnostic medical devices and active implantable

medical devices)

SECTOR 2 - Cosmetics

Sector 3 - Toys

Sector 4 - Personal Protective Equipment

SECTOR 5 - Construction Products

SECTOR 6 - Aerosol dispensers

SECTOR 7 - Simple pressure vessels and Pressure

Equipment

156

157

158

159

160

161

162

255.55

32.28

12.38

17.94

21.82

23.40

1.33

0.26

0.10

0.11

0.53

0.18

155

156

157

158

159

160

161

162

Population on 1 January 2015 as provided by Eurostat

Czech Republic, Denmark, Ireland, Italy, Cyprus, Latvia, Hungary, Portugal, Slovenia, Slovak Republic, Finland and Sweden.

Czech Republic, Denmark, Ireland, France, Italy, Hungary, Portugal, Slovenia, Slovak Republic, Finland and Sweden.

Bulgaria, Denmark, Ireland, Greece, France, Hungary, Slovenia, Finland and Sweden. For Ireland, the number includes the number

of authorised officers in Product Safety Unit with additional authorised officers available to assist on specific projects if required.

Slovenia has submitted the total number of employees. Bulgaria has submitted the total number of employees.

Belgium, Bulgaria, Denmark, Greece, France, Hungary, Finland and Sweden. Bulgaria has submitted the total number of

employees.

Belgium, Bulgaria, Czech Republic, Denmark, Greece, France, Cyprus, Hungary, Romania, Finland and Sweden. Bulgaria has

submitted the total number of employees.

Belgium, Bulgaria, Denmark, Greece, Cyprus and Finland. Bulgaria has submitted the total number of employees.

Belgium, Bulgaria, Denmark, Greece, France, Hungary, Finland and Sweden. Bulgaria has submitted the total number of

employees.

642

Sectors

Number of

Member States

providing staff

information

Average

amount of staff

available per

Member State

and per

year(simple

average)

23.27

71.67

22.51

18.41

13.54

Average

amount of staff

available per

1000000

inhabitants

(population on

1 January

2015)

155

0.21

0.41

0.58

0.42

0.14

SECTOR 8 - Transportable pressure equipment

Sector 9 - Machinery

SECTOR 10 - Lifts

SECTOR 11 - Cableways

SECTOR 12 - Noise emissions for outdoor equipment

163

164

165

166

167

SECTOR 13 - Equipment and Protective Systems

Intended for use in Potentially Explosive Atmospheres

168

12.41

0.12

SECTOR 14 - Pyrotechnics

SECTOR 15 - Explosives for civil uses

169

170

10.30

9.62

0.06

0.08

SECTOR 16 - Appliances burning gaseous fuels

171

9.82

0.08

Sector 17 - Measuring instruments, Non-automatic

weighing instruments and Pre-packaged products

172

9.91

0.07

SECTOR 18 - Electrical equipment under EMC

173

17.45

0.08

163

164

165

166

167

168

169

170

171

172

173

Bulgaria, Denmark, Greece, France, Cyprus, Hungary, Slovenia and Finland. Bulgaria has submitted the total number of employees.

Bulgaria, Denmark, Greece, France, Italy, Hungary, Finland and Sweden. Bulgaria has submitted the total number of

employees.France provided an estimate of the staff available to market surveillance activities. Sweden submitted numbers for both

the Swedish Work Environment Authority and the Swedish National Board of Housing, Building and Planning.

Bulgaria, Denmark, Greece, Hungary and Finland. Bulgaria has submitted the total number of employees.

Bulgaria, Denmark, Portugal, Slovak Republic, Finland and Sweden. Bulgaria has submitted the total number of employees.

Bulgaria, Denmark, Italy, Hungary, Finland and Sweden. Bulgaria has submitted the total number of employees.

Bulgaria, Denmark, France, Cyprus, Hungary, Finland and Sweden. Bulgaria has submitted the total number of employees.

Bulgaria, Czech Republic, Denmark, Ireland, Greece, France, Italy, Cyprus and Finland. Bulgaria has submitted the total number of

employees.

Bulgaria, Czech Republic, Ireland, Greece, France, Cyprus, Hungary and Finland. Bulgaria has submitted the total number of

employees.

Belgium, Bulgaria, Denmark, Greece, France, Cyprus, Luxembourg, Hungary and Finland. Bulgaria has submitted the total number

of employees.

Bulgaria, Denmark, France, Hungary, the Netherlands, Austria, Slovenia, Slovak Republic, Finland and Sweden. Bulgaria has

submitted the total number of employees.

Belgium, Bulgaria, Denmark, Germany, Greece, France, Cyprus, Hungary, Romania, Finland and Sweden. Bulgaria has submitted

the total number of employees.

643

Sectors

Number of

Member States

providing staff

information

Average

amount of staff

available per

Member State

and per

year(simple

average)

18.49

Average

amount of staff

available per

1000000

inhabitants

(population on

1 January

2015)

155

0.08

SECTOR 19 - Radio and telecom equipment under

RTTE

Sector 20 - Electrical appliances and equipment under

LVD

SECTOR 21 - Electrical and electronic equipment

under RoHS, WEEE and batteries

174

175

16.64

0.13

176

13.54

0.31

SECTOR 22 - Chemicals (Detergents, Paints,

Persistent organic pollutants)

SECTOR 23 - Ecodesign and Energy labelling

177

64.44

0.55

178

14.53

0.11

SECTOR 24 - Efficiency requirements for hot-boilers

fired with liquid or gaseous fuels

179

9.18

0.15

SECTOR 25 - Recreational craft

SECTOR 26 - Marine Equipment

SECTOR 27 - Motor vehicles and tyres

180

181

182

12.35

1.58

17.43

0.12

0.01

0.12

SECTOR 28 - Non-road mobile machinery

183

0.43

0.02

SECTOR 29 - Fertilisers

184

9.19

0.06

174

175

176

177

178

179

180

181

182

183

184

Belgium, Bulgaria, Denmark, Germany, Estonia, France, Cyprus, Portugal, Romania, Finland and Sweden. Bulgaria has submitted

the total number of employees.

Belgium, Bulgaria, Denmark, Greece, France, Cyprus, Latvia, Hungary, Finland and Sweden. Bulgaria has submitted the total

number of employees.

Bulgaria, Denmark, Ireland, Greece, Hungary and Finland. Bulgaria has submitted the total number of employees.

Czech Republic, Denmark, Ireland, Greece, France, Latvia, Hungary, Slovenia and Finland.

Belgium, Bulgaria, Czech Republic, Ireland, Greece, France, Cyprus, Hungary, Finland and Sweden. Bulgaria has submitted the

total number of employees.

Belgium, Ireland, Greece, Hungary, Romania and Finland.

Bulgaria, Denmark, Greece, France, Romania, Finland and Sweden. Bulgaria has submitted the total number of employees.

Denmark, France, Italy, Romania and Finland.

Belgium, Bulgaria, Denmark, France, Cyprus, Portugal, Romania, Slovenia, Finland and Sweden. Bulgaria has submitted the total

number of employees.

Denmark, Hungary and Sweden.

Belgium, Czech Republic, Denmark, Ireland, Greece, France, Latvia, Hungary, Romania, Slovenia, Slovak Republic and Finland.

644

Sectors

Number of

Member States

providing staff

information

Average

amount of staff

available per

Member State

and per

year(simple

average)

46.94

Average

amount of staff

available per

1000000

inhabitants

(population on

1 January

2015)

155

0.47

SECTOR 30 - Other consumer products under GPSD

185

Bulgaria, France, Hungary, Finland and Sweden. Bulgaria has submitted the total number of employees.

645

The reasons behind all of the differences presented in this section of the study will be further

investigated during

the interviews, the details to be required depending on the interviewee’s

experience and expertise.

Figure 8-12: Variation of total number of inspectors (FTE units) available to MSAs per

year, during 2010-2013

275%

225%

175%

125%

75%

25%

LV BG

DK EE

RO CZ

-25%

-75%

Source: National reports

At country level, the analysis of the change in the number of inspectors available to MSAs

annually reflects the following:



In the majority of countries (10 out 16) the number of inspectors decreased;

Six countries (Bulgaria, Italy, Denmark, Estonia, Finland, and Romania) had relatively

stable trends, with the increase or decrease in the number of inspectors not being higher

than 5% of the number of inspectors available to MSAs in 2010;

A significant increase (263.8%) was registered in Ireland.

Except for two countries (Ireland and Poland), the overall trend in the total inspectors

available to MSAs during the four years considered tends to be aligned with the one for

the total staff available to MSAs..

On the basis of the figure on budgets and number of inspections provided by Member

States the following estimates of costs of enforcement are provided. It is noted they are

largely variable due to the limited number of data points and some issues of

comparability.

650

Table 8-7: Indicative estimate of costs of inspections in Member States

Country

Average

number of

annual

inspections

Average

Annual

Budget

available

for

(B)

n/a

946903

2114559

n/a

384594.1

11675000

8386750

n/a

23785801

7417861

1680000

n/a

4825000

1561372

74875

n/a

1818645

163592.3

20000000

10229088

25229517

320108.1

12370917

5634232

74875

25229517

7295727

Average

costs per

inspection

Average

annual

costs per

number inspector

Inspectors

(C)

n/a

9.375

232.25

n/a

426.25

n/a

32.5

42.25

n/a

183.25

64.85

n/a

70.2025

917

5.4375

1.15

78.125

n/a

1455.5

330.375

377.25

n/a

280.75

1.15

1455.5

281.6572

(B)/(C)

n/a

101003

9104.668

n/a

902.2734

n/a

258053.8

n/a

129799.7

114384.9

n/a

68729.75

1702.695

13770.11

n/a

23278.65

n/a

7027.886

76366.3

848.5305

n/a

20068.5

848.5305

258053.8

58931.49

min

max

average

(A)

1966

n/a

121

20.75

1382.25

n/a

107.5

1277.75

n/a

395.5

1589.5

103.75

12391.25

48.25

1416.5

n/a

437.75

83.75

n/a

236.75

3182

n/a

155.25

n/a

20.75

12391.25

1465.618

(B)/(A)

n/a

17475.7

n/a

278.2377

n/a

78016.28

n/a

18755.65

1056.936

n/a

100000

1102.274

n/a

4154.528

1953.34

n/a

43206.29

7928.824

n/a

79683.85

n/a

278.2377

100000

29467.66

Source: draft Evaluation study

651

3.4

Information on resources based on reports for the chemicals area

REACH and Classification and Labelling of Products regulation (CLP), 22 countries provided

information on the resources allocated to enforcing authorities for tasks related to the

enforcement of REACH. Among them, 12 indicated that it was difficult, and in most cases

impossible to provide an estimate of the annual budget and staff dedicated to REACH

enforcement, since inspectors carry out tasks related to more than 1 legislation, often in joint

inspections, and no separate budget is allocated specifically to REACH. 15 countries provided

an estimate of annual staff and/or budget dedicated to REACH enforcement.

Table 8-8: Staff and budget allocated to REACH enforcement

Country

Austria

Staff dedicated to REACH enforcement

In average, a resource of 1 man-year is available

for enforcement activities related to the whole

chemical legislation in the competence of the

inspectorates in each of the Lander (9 man-year in

total).

4 inspectors on national level 30 inspectors on

regional level

13 regional inspectors responsible for chemical

legislation

The Chemical Inspection Service: 3 man-years

enforcing REACH

Danish Working Environment Authority special

unit on market surveillance: 2 man-year enforcing

SDS and ES; 0.1 man-year for general inspection

in which REACH is discussed

Danish Maritime Authority: 0.1 man-year for

general inspection in which REACH is discussed

France

Greece

Hungary

Ministry of Ecology: 26 environment inspectors

enforce REACH

55 chemists in NEA perform tasks related to

REACH

There are approximately 90 chemical safety

inspectors responsible for the whole chemical

safety legislation in the competence of the NEA

EPA: ~0.2FTE for work associated with REACH

DAFM: 27 staff enforcing REACH related to

pesticides

HSA: 12.9 FTEs inspectors for chemical legislation

(approximately 3.2 FTE for REACH and CLP)

Liechtenstein

1 inspector in NEA

EPA: Approximately €6,200 (not

including labour costs) for

REACH and Detergents

Regulation

HSA: 250,000 - 300,000 Euros

(including only human resources)

Budget allocated to REACH

enforcement

Croatia

Czech Republic

Denmark

Ireland

652

Country

Lithuania

Staff dedicated to REACH enforcement

State environmental protection service has 3

inspectors specialised in enforcing chemical

legislation

There is approximately 8.6 FTE in the NEA

working on REACH

The Inspection of Environmental Protection has

allocated 20 full-time jobs dedicated to

enforcement of REACH to regional (Voivodship)

inspectorates of Environmental Protection.

The State Labour Inspectorate and the District

Labour Inspectorates all have a REACH

coordinator.

Budget allocated to REACH

enforcement

Norway

Poland

Portugal

IGAMAOT has 7 inspectors allocated to REACH,

CLP, Seveso Directive and other environmental

legislation

4 inspectors in NEA

The Compliance Team of HSE has 3 FTEs to work

on REACH. There are other Enforcers also

working on REACH.

HSENI has 0.1 FTE. NIEA has 4 staff (not full

time on REACH). Environmental Agency has 5.4

staff (not full time on REACH).

Slovenia

United Kingdom

Cells were left blank when CAs have not reported any information.

Out of the 22 countries which provided information on the level of resources dedicated to the

Classification and Labelling of Products regulation (CLP), 13 have reported the same

information as for the enforcement of REACH. As previously mentioned, a lot of countries do

not have resources specifically allocated to the enforcement of CLP or REACH, which is

covered by the CA’s budget. 5 countries provided specific data for CLP:

Table 8-9: Staff and budget allocated to CLP enforcement

Country

Belgium

Staff dedicated to CLP enforcement

Federal Environmental Inspection: 2011: 7 FTE;

2012: 5 FTE; 2013: 6 FTE; 2014: 7.2 FTE

Budget allocated to CLP

enforcement

General budget (including

analysis) 2011: €276,000; 2012:

€289,000; 2013: €223,000; 2014:

€160,350 (total cost for the

inspection service (inspectors,

technical experts and controllers

on the transit of waste).

Croatia

Denmark

4 inspectors at national level 20 inspectors at

regional level

2 man-year

653

Country

Iceland

Latvia

Staff dedicated to CLP enforcement

0.1 FTE in the Environment Agency

Impossible to distinguish resources only dedicated

to CLP. However Health Inspectorate has

indicated that they have 10 persons involved in

CLP control.

Budget allocated to CLP

enforcement

Annual budget of Health

Inspectorate for enforcement of

chemicals and cosmetics

legislation is approximately

300,000 EUR.

654

NNEX

9: JRC R

EPORT ON

ARKET

URVEILLANCE OF NON

FOOD PRODUCTS

ASED ON A

SMALL

SCALE SURVEY CARRIED OUT IN

EBRUARY

2017

NTRODUCTION

This report presents the result of a survey on Market Surveillance (MS) conducted by the

Joint research Centre (European Commission), on behalf the Single Market Policy, Mutual

Recognition and Surveillance Unit, in DG GROW.

A short questionnaire

–

in the Annex of this report

–

was sent via e-mail to a subset of ADCO

(Administrative Cooperation Groups) members. These had volunteered to provide their view

on the current status of Market Surveillance activity in EU and on future possible

developments. Out of the 13 members contacted, 10 replied to the survey (a 77% response

rate). However, 2 respondents

–

based in the same Country

–

submitted the very same reply,

across all questions. We decided to include only one of these two replies as, given the small

size of the sample, this would have biased the results.

The questionnaire includes 6 sections: 1) on market surveillance, in general; 2) on

cooperation, in general; 3) on internal cooperation; 4) on EU cooperation; 5) on national

cooperation and 6) on personal information. We will present the results by following the

various sections of the questionnaire.

1.1

On market Surveillance, in general

In question 1 we asked the respondents’ view on 13 statements related to Market Surveillance.

Respondents could choose between the following options:

Strongly agree;

Agree;

Disagree;

Strongly disagree;

Not to express any view (“don’t know (DK)”).

60%

50%

40%

30%

20%

10%

Agree

Disagree

Strongly disagree

Figure 9-1:

“Product harmonisation legislation is overly complex”

655

We observed divergent views on whether “product harmonisation legislation is overly

complex”, with roughly half of respondents agreeing this is the case, and the other half of

them either disagreeing or strongly disagreeing (see Fig. 9-1). It would be interesting, in the

future, to find out the motivations underpinning such different views, for example, whether

this is due to specific sectors or to other reasons.

The second statement tackles the reverse side of the coin of complex legislation. Whether or

not we agree that product harmonisation legislation is complex, it is relevant to find out

whether the resources allocated to effectively perform MS are sufficient. Almost 80% of

respondents expressed the view that MS is under-budgeted in their own Country, or in their

sector of activity (Fig. 9-2).

70%

60%

50%

40%

30%

20%

10%

Strongly agree

Agree

Disagree

Figure 9-2:

“MS is under-budgeted

in my

own Country, in my sector of activity”

From a behavioural perspective, in order to explore all possible explanations of a specific

behaviour, it is often interesting to find out about what others are doing or about our

perceptions of what others do. Indeed, we do not live in a social vacuum but we are rather

influenced by others. This is particularly the case with respect to an activity with is performed

and financed by each EU MSs, but that is functional to the pursuit of a public good. For

example, in the iterative Public Good Game - used to study the tension between the individual

incentive to free ride in collective activities of this type, and the social benefit generated by

the sum of individual investments

–

the investment of a specific member decreases when

(s)he observes free-riding behaviour from others. In the absence of corrective measures, this

often leads to a

race to the bottom.

In our case, 2/3 of respondents shared the view that MS is

under-budgeted across the EU, in their sector of activity (Fig. 9-3). In the future, it would be

worth finding out whether there is any causal relationship between the perceptions described

in Fig. 9-3

and each individual EU Country’s willingness to invest in MS.

656

35%

30%

25%

20%

15%

10%

Strongly agree

Agree

Figure 9-3:

“MS is under-budgeted

across the EU,

in my sector of activity”

Within-Country

coordination between the various office of MS Authorities doesn’t seem to be

too much of an issue, though there seems to be room for improvement in specific Countries.

30% of respondents agreed with the following

statement: “There is poor within-Country

coordination between the various local offices of MS Authorities” (Fig. 9-4).

70%

60%

50%

40%

30%

20%

10%

Agree

Disagree

Figure 9-4:

“There is poor within-Country

coordination between the various local

offices of MS Authorities”

The respondents’ view of the

quality of within-Country coordination with Customs roughly

reflects the situation within MS Authorities, with 1/3 of respondents agreeing that there is a

margin of improvement (Fig. 9-5).

657

Figure 9-5:

“There is poor within-Country

coordination with Customs”

Interestingly, respondents seemed to be slightly less happy about the quality of cross-border

coordination of national MS Authorities. 40% of them agreed with the following statement:

“There is poor cross-border

coordination of national MS Authorities”

(Fig. 9-6).

60%

50%

40%

30%

20%

10%

Agree

Disagree

Figure 9-6:

“There is poor cross-border coordination of national MS Authorities”

When it comes to solutions or possible remedies, it is fairly clear that MS cannot rely on

consumers’ awareness. Indeed, there is a common view that

consumers are not aware about

EU product harmonisation legislation (Fig. 9-7).

60%

50%

40%

30%

20%

10%

Disagree

Strongly disagree

Figure 9-7:

“There is great consumers’ awareness about EU product harmonisation

legislation”

658

As to firms’ awareness of EU product harmonisation legislation, respondents’ perception

seems to be different, depending on whether this relates to EU or non-EU firms (Figures 9-8

and 9-9, respectively). In particular, while 30% of respondents think that EU firms have great

awareness of EU product harmonisation legislation, none of the respondents believe this is the

case for non-EU firms.

70%

60%

50%

40%

30%

20%

10%

Agree

Disagree

Figure 9-8:

“EU firms have great awareness of EU product harmonisation legislation”

50%

45%

40%

35%

30%

25%

20%

15%

10%

Disagree

Strongly disagree

Figure 9-9:

“Non-EU

firms have great awareness of EU product harmonisation

legislation”

Cooperation with the private sector to identify non-compliant products seems to be a

relatively under-explored area (Fig. 9-10).

659

70%

60%

50%

40%

30%

20%

10%

Agree

Disagree

Strongly

disagree

Figure 9-10:

“There is great cooperation with the private sector to

identify non-

compliant products (e.g, with actors in the online supply chain)”

90%

80%

70%

60%

50%

40%

30%

20%

10%

Strongly agree

Agree

Figure 9-11:

“Over the last 10 years, there has been an improvement of MS activity in

EU”

We also observed a marked divergence of opinions as to whether product compliance should

be encouraged by using the carrot instead of the stick (Fig. 9-12), that is by timely advice and

information to operators (only 1/3 of the respondents were of this opinion) instead of by

imposing fines and penalties for non-compliance (55% believed that the latter are more

effective).

660

50%

45%

40%

35%

30%

25%

20%

15%

10%

Strongly

agree

Agree

Disagree

Strongly

disagree

Figure 9-12:

“Penalties and fines for non-compliance

are less effective than timely advice

and information to operators”

We also wondered whether using incentives for consumers contributing to MS Activity could

in time become a complementary approach, but only 10% agreed whereas 45% disagreed and

the remaining 45% said they “didn’t know” (Fig. 9-13).

50%

45%

40%

35%

30%

25%

20%

15%

10%

Agree

Disagree

Figure 9-13:

“Consumers filing an appropriate complaint related to product-related

harmonisation should be properly compensated,

for having contributed to MS Activity”

Finally, we asked whether the respondents identified any other specific factors that are

relevant to pursue an effective MS Activity, and we collected interesting insights:

“On

e-Commerce:

The import of products directly to the end user and the new concept of

involving “fulfilment houses” with (at the moment) no responsibilities is a large problem. The

competitive disadvantage for both European manufacturer and importers are obvious.

Furthermore the European end-users are receiving and using non-compliant products for

which

–

in most of the cases

–

no responsible party in the EU exists. A responsible party for

each product located within EU (like for Medical devices) or the introduction of a

registration system for all products could be a solution. A registration system would make it

easier for customs to determine if a product can enter the market or not without involving

661

national MSA. In a nutshell, there seems to be a lack of effective measures and tools to

prevent a flow of dangerous products sold online.”

“The availability of specialist resources to carry out testing, or lack of in

-house laboratories.

This is particularly the case for eco-design and energy labelling, the testing of which is often

costly.”

“Reinforcement of cooperation via AdCo Groups, despite some AdCO members are not

entitled to take decisions.”

“Accessibility and cost of standards for the MSA and economic operators, especially if the

MSA covers several Directives.”

“A better definition o

f the role of Customs, in order to better address the many imports of

non-

compliant products.”

“in

many cases, the time spent for a MS procedure is longer than the

life cycle of the

product. This means that a product is no longer on the market when the sales ban is

pronounced;

it is simple for a manufacturer to shorten a sales ban: by changing the identification of

the product, the MS authority is obliged to start a new procedure;

a sales ban in one country is not automatically valid for all countries;

legal procedures too time-consuming and resource-intensive

no control if a product banned from the market of an EU country may come back

through other channels to another national market;

even if there is the idea of a common internal market, it seems that market surveillance

is still focussed on national market;



different national prosecution legislation.”

The replies to our questions and the comments provided constitute invaluable insights for any

discussion as to the approaches and priorities of any future MS Activity.

1.2

Cooperation activity

In the general section on cooperation activity, we asked a series of question that were

designed to convey respondents’ relative appreciation of the potential benefits coming from

various types of cooperation activity.

In question 3 we asked “In your view, what specific type of market surveillance cooperation

brings most value for money”. Interestingly, no respondent mentioned national cooperation,

while almost 80% mentioned EU Cooperation, and the remaining 20% opted for International

Cooperation (Fig. 9-14).

662

90%

80%

70%

60%

50%

40%

30%

20%

10%

International

Cooperation

EU Cooperation

National Cooperation

Figure 9-14:

“In your view, what specific type of market surveillance cooperation brings

most value for money”

A number of reasons were put forward to justify the preference for international and EU

cooperation:

“With the globalisation and Internet, there are no border any more for products, this means

that in future, there will be a change, people will buy more and more from internet and less

from “normal” shops. Most of the products will be delivered from ou

tside EU and the

resources needed for their check at the EU border will be disproportionate. Therefore if an

international cooperation would be possible to stop the products at the source, it will be more

effective and efficient. Furthermore, as soon as a manufacturer has placed a product on a

specific market (e.g. outside EU), this product is not anymore under its control. An EU

importer may buy a batch of this product and placed it on the EU market even if the intention

of the manufacturer was not to plac

e it on the EU market.”

“

Free movement of goods allows to place products anywhere within the European Economic

Area, so the cooperation among EU MSAs is crucial to stop rough traders effectively.

Networks created within ADCO groups as well as EU RAPEX or ICSMS systems help to

comm

unicate rapidly and to ensure consumers safety. Cooperation with big producers’

countries is important as well but education and awareness campaigns addressed to

European economic operators and a simplification of EU product harmonisation legislation

seem to be more effective.

”

“It

gives most value if the market surveillance authority can take non-complaint product out

of the marked in EU and not only out of national markets.”

“International cooperation with MSA/Government outside EU might reduce the numbe

r of

non-

compliant products being made available on the EU market.”

With questions 5-7, we further explored the same issue. The replies to these questions could

be used in the future to strike to most appropriate balance between various types of

cooperation activities, avoiding overinvesting or underinvesting in any of them. We asked

respondents to provide an estimate of the budget percentage allocated to



International cooperation

EU cooperation and

663



national cooperation

both by their own Country and by other Countries. We also asked what budget percentage

they would themselves allocate to each cooperation level, were they free to choose.

The results show first of all that respondents understood the objective of the question

–

which

was a follow-up of question 3 (see Fig. 9-14)

–

and its relevance, as they all provided

estimates.

On international cooperation, whereas the average perceived budget allocation by the home

Country is 3.3%, the respondents’ average ideal budget allocation is 18%, which provides

quantification of the extent to which international cooperation should represent more of a

priority.

Respondents’ ideal % budget allocation to EU cooperation

Respondents' perception of other Cntries' % budg. all. to EU coop.

Respondents’ perception of own Cntry % budget allocation to EU cooperation

Figures 9-15a and 9-15b:

Respondents’ perception of and preference for budget

allocated to EU cooperation

On EU cooperation, two results are worth noticing:



respondents tend to perceive their home Country as more engaged (at least from a

budgetary point of view) in EU cooperation (Fig. 15a). Indeed, if all respondents

perceived other Countries to invest as much as their home Country in EU cooperation,

all observations would fall on the 45° line (whereas in our case, all but one fall above

the 45° line). From a behavioural point of view, perceiving others as less engaged

could discourage one’s own engagement. Therefore this could be object of a specific

intervention;

respondents ideal budget allocation on EU cooperation tends to be larger than the

perceived budget allocation of one’s own Country. When this is not the case, it is to

the benefit of international cooperation, rather than to national cooperation (Fig. 15b).



Finally, on national cooperation, the opposite applies. Respondents’ ideal budget allocation to

national cooperation is below the perceived budget allocation of both their own Country (Fig.

9-16a) and of other Countries (Fig. 9-16b). Again,

these results clarify the respondents’ view

as to what type of cooperation activity should be seen as a priority.

664

Respondents' perception of home Cntry % budg. all. to nat. coop.

100

Respondent's perception of other Cntries' % budget allocation to national cooperation

Figures 9-16a and 9-16b:

Respondents’ perception of and preference for budget

allocated to national cooperation

1.3

International cooperation activity

In question 8 we asked the respondents’ view on 7 statements related to International

Cooperation Activity. Respondents could choose between the following options:

Strongly agree;

Agree;

Disagree;

Strongly disagree;

Not to express any

view (“don’t know (DK)”).

From a behavioural perspective, an analysis of the target population is a fundamental

prerequisite to be able to design effective interventions. Indeed, considering the private sector

as a homogeneous population of firms, regardless of their size, their sector, their international

exposure or their Country, would prevent any possibility of targeting and tailoring specific

interventions.

Respondents see differences between various types of companies, multinationals, EU SMEs

and non-EU SMEs. Only 10% of respondents perceived that multinationals tend to be non-

compliant, while 20% of them said the same about EU SMEs, and a striking 80% thought that

non-EU SMEs tend to be non-compliant (Figures 9-17 to 9-19). This result, coupled with the

view that more attention should be paid at international (beyond EU) cooperation, should

suggest specific lines of actions which have probably been under-explored so far.

665

100

50%

40%

30%

20%

10%

Strongly

agree

Agree

Disagree

Figure 9-17:

“Multinationals tend to be compliant with EU product harmonisation

legislation”

70%

60%

50%

40%

30%

20%

10%

Agree

Disagree

Figure 9-18:

“EU SMEs tend to be compliant with EU product harmonisation

legislation”

50%

40%

30%

20%

10%

Disagree

Strongly disagree

Figure 9-19:

“Non-EU

SMEs tend to be compliant with EU product harmonisation

legislation”

As it happened to the data presented in Figure 9-15, respondents tended to show some level of

“overconfidence” projected to their own country. To the question “Do national customs

perform thorough controls of incoming goods”, they in fact responded differently depending

666

on whether this referred to their own Country (Fig. 9-20) or to other Countries (Fig. 9-21).

While 45% agreed that national Customs of their own Country perform through controls of

incoming goods, only 45% disagreed that this also applies to national Customs of foreign EU

Countries.

50%

45%

40%

35%

30%

25%

20%

15%

10%

Agree

Disagree

Strongly

disagree

Figure 9-20:

“National Customs of my Country perform thorough controls of incoming

goods”

35%

30%

25%

20%

15%

10%

Agree

Disagree

Strongly

disagree

Figure 9-21:

“National Customs of other EU Countries perform thorough controls of

incoming goods”

The scale of the challenge for MS Authorities should not be undermined, however. Although

all respondents agreed that “Over the last 10 years, there has been an improvement of MS

activity in EU” (see Fig. 9-11 above), more that half of them believe that “Over the last 10

years, the proportion of non-EU non-compliant products that entered the EU market has

decreased” (Fig. 9-22).

667

35%

30%

25%

20%

15%

10%

Agree

Disagree

Strongly

disagree

Figure 9-22:

“Over the last 10 years, the proportion of non-EU

non-compliant products

that entered the EU market has decreased”

Interestingly, 2/3 of respondents agree that “Cooperation with sectoral SMEs associations

non-EU Countries could provide up-front advice and information and limit enforcement

costs” (Fig. 9-23),

a finding that resonates well with the view that international surveillance

cooperation brings good value for money (see Fig. 9-14 above).

60%

50%

40%

30%

20%

10%

Strongly agree

Agree

Figure 9-23:

“Cooperation with sectoral SMEs associations of non-EU

Countries could

provide up-front

advice and information and limit enforcement costs”

Finally, we asked whether the respondents identified any other specific factors that may

improve the effectiveness of International cooperation on Market Surveillance activity for

goods or services, we collected interesting insights:

“

Improving the communication, control, cooperation, performance and enforcement among

Custom authorities in the EU member states, for example early notifications for incoming

risky goods

.”

“

European standards should be obligatory to eliminate uncertainty of law and be changed

only due to technology progress.

”

“

Stop non-compliant products at the border. Improve cooperation between MSAs and

Customs.”

668

“

- to give a certain responsibility to the consumer who is buying products from outside EU,

looking only at the price (in this case the consumer is responsible to support unfair

competition);

- to find an effective way on how to perform market surveillance on products sold via

Internet;

- to concentrate the information on non-compliant products on one single homepage (e.g.

public part of ICSMS) instead to have this information on many homepages;

- to concentrate the information on the rules on one single point (today the information is

located on various homepages between commission an Member States);

- to give consumers the tools to search for and filter out non-

compliant products.”

“

More joint actions funded by the EU, organized and carried out by MSAs in ADCOs

”

“

A number of products manufactured in a non-EU country do not fulfil the requirements of

the applicable European legislation. Importers (if available because of the new “fulfilment

houses” challenge) are only partly able t

o verify if a product complies with the requirements

or not, as they are often just salesmen

.”

Some of these insights identify the underlying causes challenging the effectiveness of MS

activity, whereas others rather focus on possible remedies. In this perspective, these indicate

possible lines of work that could further pursued by ADCOs.

1.4

Within-EU cooperation activity

With reference to the work and discussions taking place within the Administrative Co-

operation Working Group (ADCO), in question 10

we asked “what does prevent or hamper

you from implementing the necessary changes within your national context?” Respondents

could select up to 3 options and could rank them from 1, the most important, to 3, the third-

most important.

The three main reasons hampering the implementation of the necessary changes within each

respective national context seems to be (see Table 9-1):

The complexity of the respondent’s administration, and the fact that the common line

agreed within the ADCO does not trickle down to all levels;

The low recognition and value attributed by the respondent’s respective administration

to his/her role of “connector” between his/her MSA and foreign MSAs;

The fact that “only half of EU countries regularly attend ADCO’s meetings”.

Number of replies per rank

My management does not show interest for the views expressed by the ADCO

My colleagues do not show interest for the views expressed by the ADCO

My role of “connector” between my MSA and foreign MSA is not properly

recognised and

669

valued by my administration

Our administration is complex, and the common line agreed within the ADCO does not

trickle down to all levels

There is a general perception that foreign MSAs don’t take any concrete action

Only

half of EU countries regularly attend ADCO’s meetings

My management does not show interest for the views expressed by the ADCO

Table 9-1:

“What does prevent or hamper you from implementing the necessary

changes within your national context? (Up to 3 possible options, ranked from 1 (top one)

to 3 (bottom one)”

As to the reasons why each respondent’s management and/or colleagues do not easily endorse

the common line agreed within the ADCO, on certain matters, all respondents agreed that this

not

because the line agreed within the ADCO brings more costs than benefits. This is a key

result as it is a clear acknowledgement of the benefits of following the line agreed with the

ADCO (see Fig 9-24). However ¼ of replies stressed that the line agreed within the ADCO is

often not clear, another ¼ complained that only half of EU MSs regularly attend ADCO’s

meetings, and about 1/6 of replies stated that there is a general perception that foreign MSAs

would not endorse the line agreed within the ADCO and that such perception, as a result,

discouraged others to endorse it.

35%

30%

25%

20%

15%

10%

Line agreed

There is a general Only half of EU

within the ADCO within the ADCO perception that

MSs regularly

is often not clear brings more costs foreign MSAs

attend ADCO's

than benefits

would not

meetings

endorse it

Other

Figure 9-24:

“What could be the reasons why your management and/or colleagues do

not easily endorse the common line agreed within the ADCO, on certain matters?

(Multiple replies possible)”

One third of respondents opted for “Other” reasons, and suggested that:

“

In general there is easy endorsement of a common line agreed, within the ADCO (ECHA

FORUM), once the common line is robust and well founded/argumented, in relation to the

relevant EU aquis. Also clear positions by COM or EU Agencies (like ECHA) are helpful for

having good national endorsement

.”

670

“

- The decisions taken by ADCO are not legally binding

- National prosecution legislation is instead binding though it differs by Country.

- Less than half of MSA attending ADCO are concretely active, the rest attends on a rather

listening mode.”

“Sometimes implementing the common line agreed within the ADCO requires us to commit

significant resource outside our core function.”

“

In some cases, my administration cannot implement ADCO agreements as these are not

compatible with the national transposition of the relevant Directive.

“

From the previous result it does not come as a surprise that most respondents state that they

do not find it easy to involve their own MSA in joint actions proposed in ADCO meetings

(Fig. 9-25). Indeed, some argue that this is due to the specific governance structure of their

own Country, to their involvement in other type of joint actions or simply to funding issues.

On the other hand, some of those replying that it is easy, point out that “

the number of

participants to joint actions is very important for the acceptance of the results of those

actions.

”

60%

50%

40%

30%

20%

10%

Yes

Figure 9-25:

“Do you find easy to involve your MSA in joint actions

proposed in ADCO

meetings?”

1.5

National cooperation activity

In question 13 we asked the respondents’ view on 8 statements related to national cooperation

activity. Respondents could choose between the following options:

Strongly agree;

Agree;

Disagree;

Strongly disagree;

Not to express any view (“don’t know (DK)”).

671

The landscape of Market Surveillance seems to be less complex and problematic. 2/3 of

respondents say that their respective Country has a single Authority responsible on their

specific sector, ¾ of respondents declare that cooperation within the local offices of their

respective Authority is effective and only 10% thinks that “within my Authority, there are

overlapping responsibilities that generate confusion and waste of resources” (Figures

9-26 to

9-28).

50%

45%

40%

35%

30%

25%

20%

15%

10%

Strongly agree

Agree

Disagree

Figure 9-26:

“We have a single Authority responsible on my sector”

50%

40%

30%

20%

10%

Strongly agree

Agree

Disagree

Figure 9-27:

“Cooperation within the local offices of our Authority is effective”

672

90%

80%

70%

60%

50%

40%

30%

20%

10%

Agree

Disagree

Strongly disagree

Figure 9-28:

“Within my Authority, there are overlapping responsibilities that generate

confusion and waste of resources”

Notwithstanding, ¾ of respondents believe that collaboration with national Customs could be

further developed and deepened, perhaps in view of avoiding overlapping responsibilities,

witnessed by 30% of respondents (respectively Fig. 29 and Fig. 30).

60%

50%

40%

30%

20%

10%

Strongly agree

Agree

Disagree

Figure 9-29:

“Collaboration with Customs could be further developed and deepened”

60%

50%

40%

30%

20%

10%

Strongly agree

Agree

Disagree

Strongly

disagree

Figure 9-30:

“Between national relevant bodies, there are overlapping responsibilities

that generate confusion and waste of resources”

673

On the possible remedies to improve national cooperation activity, almost half of the

respondents believe that “Incentives for effective MS Activity could be better designed (e.g.,

the overall national budget for MS Activity should better reflect the results obtained by each

office)” (Fig. 9-31).

50%

45%

40%

35%

30%

25%

20%

15%

10%

Agree

Disagree

Figure 9-31:

“Incentives for effective MS Activity could be better designed (e.g., the

overall national budget for MS Activity should better reflect the results obtained by

each office)”

In this section we also enquired about the potential usefulness of consumer awareness

campaigns. Surprisingly, as respondents had previously stated that consumers are not aware

about EU product harmonisation legislation (Fig. 9-7), in this case respondents argue that

consumer awareness campaigns bring concrete results (Fig. 9-32). In the future, it would be

necessary to clarify whether they think that future awareness campaigns are necessary

because of consumers’ currently low level of awareness of EU product

harmonisation

legislation.

90%

80%

70%

60%

50%

40%

30%

20%

10%

Strongly agree

Agree

Figure 9-32:

“Consumer awareness campaigns are good value for money (i.e., they bring

concrete results)”

674

Finally, in line with a more preventive approach observed in other sections of the survey, 2/3

of respondents agreed

that “more collaboration with business sectoral associations should be

developed” (Fig. 9-33).

50%

45%

40%

35%

30%

25%

20%

15%

10%

Strongly agree

Agree

Disagree

Figure 9-33:

“More collaboration with business sectoral associations should be

developed”

Finally, we asked whether the respondents identified any other specific factors that may

improve the effectiveness of national cooperation on Market Surveillance activity, and we

collected insightful comments:

“Clear

joint actions planning of the inspections.”

“

More frequent and perhaps real-time communication and consultation on tough cases.

”

“

It might be useful (necessary) to agree on a common working language (e.g. English) and

colleagues enforcing EU-harmonisation legislation should be familiar with that language.

Capacity-building actions could be considered as we should make sure that officers should be

competent in the relevant sector.”

“

Common national prosecution rules;

No “safeguard clause” anymore: the decision taken by a national market surveillance

authority is automatically valid for the whole EU internal market (economic operators have

the possibility to appeal from a decision at national level);

- Better coordination and exchange of information between MSA to avoid double checks;

- Benchmarking between MSA on how to assess the requirements.

”

“

Better cooperation between colleagues participating in meetings with the European

Commission and the people who do the market surveillance.

- Better cooperation between the people who do the national market surveillance in the

harmonized area.

”

675

“

Most of the products entering the EU market are not only covered by one European

Directive. Customs sometimes do not know which national MSA to involve. This should be

improved.

- More clear rules for products imported from non EU would make it easier for customs to

determine if a product can enter the EU market (e.g., mandatory DoC accompanying the

product; the identification of one responsible party for placing a product on the EU market

and at least one contact party within the EU; the obligation of a user manual in the language

of the customs country).

”

ANNEX: QUESTIONNAIRE

SECTION 1 / 6: ON MARKET SURVEILLANCE, IN GENERAL

Question 1

Please express your view on the following statements related to Market Surveillance (MS):

Strongly

agree

1. Product harmonisation legislation is overly complex

2. MS is under-budgeted in my own Country, in my

sector of activity

3. MS is under-budgeted across the EU, in my sector of

activity

4. There is poor within-Country coordination between

the various local offices of MS Authorities

5. There is poor within-Country coordination with

customs

6. There is poor cross-border coordination of national

MS Authorities

7. There is great consumers’

awareness about EU

product harmonisation legislation

8. EU firms have great awareness of EU product

harmonisation legislation

9. Non-EU firms have great awareness of EU product

harmonisation legislation

10. There is great cooperation with the private sector to

identify non-compliant products (e.g, with actors in the

online supply chain)

11. Over the last 10 years, there has been an

improvement of MS activity in EU

Agree

Disagree

Strongly

disagree

I don’t

know

676

12. Penalties and fines for non compliance are less

effective than timely advice and information to

operators

13. Consumers filing an appropriate complaint related

to product-related harmonisation should be properly

compensated, for having contributed to MS Activity

Question 2

Please indicate and comment on other specific factors that, in your view, may hinder an

effective Market Surveillance activity:

SECTION 2 / 6: COOPERATION ACTIVITY

Question 3

In your view, what specific type of market surveillance cooperation brings most value for

money?



International cooperation (outside EU)

EU cooperation

National cooperation

Question 4

Please briefly explain why:

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Question 5

Speaking of cooperation, how do you believe your Market Surveillance Authority roughly

allocate the available budget across the following cooperation activities, on average, in

percentage terms? (Please make sure the total adds up to 100)

Description of the Activity

International cooperation (outside EU)

EU cooperation

National cooperation

100

Percentage

Question 6

How do you believe foreign Market Surveillance Authorities roughly allocate their available

budget across the following cooperation activities, on average, in percentage terms? (Please

make sure the total adds up to 100)

Description of the Activity

International cooperation (outside EU)

EU cooperation

National cooperation

100

Percentage

Question 7

Imagine

you could freely decide how to allocate your Authority’s budget across the following

cooperation activities. How would you allocate it in percentage terms? (Please make sure the

total adds up to 100)

Description of the Activity

International cooperation (outside EU)

EU cooperation

National cooperation

100

Percentage

678

SECTION 3 / 6: INTERNATIONAL COOPERATION ACTIVITY

Question 8

Please express your view on the following statements related to international cooperation

related to Market Surveillance (MS) activity:

Strongly

agree

1. Multinationals tend to be compliant with EU

product harmonisation legislation

2. EU SMEs tend to be compliant with EU product

harmonisation legislation

3. Non-EU SMEs tend to be compliant with EU

product harmonisation legislation

4. National customs of my Country perform thorough

controls of incoming goods

5. National customs of other EU Countries perform

thorough controls of incoming goods

6. Over the last 10 years, the proportion of non-EU

non-compliant products that entered the EU market

has decreased

7. Cooperation with sectoral SMEs associations of

non-EU Countries could provide up-front advice and

information and limit enforcement costs

Agree

Disagree

Strongly

disagree

I don’t

know

Question 9

Please indicate and comment on other specific factors that, in your view, may improve the

effectiveness of cooperation on Market Surveillance activity for non-EU goods or services:

679

SECTION 4 / 6: WITHIN-EU COOPERATION ACTIVITY

Question 10

With reference to the work and discussions taking place within the Administrative Co-

operation Working Group (ADCO), what does prevent or hamper you from implementing the

necessary changes within your national context? (Up to 3 options can be selected please order

them from 1, the most important, to 3, the third-most important)



My management does not show interest for the views expressed by the ADCO

My colleagues do not show interest for the views expressed by the ADCO

My role of

“connector” between my MSA and foreign MSA is not properly recognised

and valued by my administration

Our administration is complex, and the common line agreed within the ADCO does not

trickle down at all levels

There is a general perception that foreign

MSAs don’t take any concrete action

Only half of EU countries regularly attend ADCO’s meetings



Question 11

What could be the reasons why your management and/or colleagues do not easily endorse the

common line agreed within the ADCO, on certain matters? (multiple replies are possible)



The common line agreed within the ADCO is often not clear

The common line agreed within the ADCO brings more costs than benefits

There is a general perception that foreign MSAs would not endorse it

Only half of

EU countries regularly attend ADCO’s meetings

Other

If “other”, please briefly explain why:

680

Question 12

Do you find it easy to involve your MSA in joint actions proposed in ADCO meetings?



Yes

Please briefly explain why:

SECTION 5 / 6: NATIONAL COOPERATION ACTIVITY

Question 13

Please express your view on the following statements related to the cooperation activity

carried out with other offices of your Authority, or with other relevant national bodies of your

Country:

Strongly

agree

1. We have a single Authority responsible on my

sector

2. Cooperation within the local offices of our

Authority is effective

3. Within my Authority, there are overlapping

responsibilities that generate confusion and waste of

resources

4. Collaboration with Customs could be further

developed and deepened

5. Between national relevant bodies, there are

overlapping responsibilities that generate confusion

and waste of resources

6. Incentives for effective MS Activity could be better

designed (e.g., the overall national budget for MS

Activity should better reflect the results obtained by

each office)

7. Consumer awareness campaigns are good value for

money (i.e., they bring concrete results)

Agree

Disagree

Strongly

disagree

I don’t

know

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8. More collaboration with

associations should be developed

business

sectoral

Question 14

Please indicate and comment on other specific factors that, in your view, may improve the

effectiveness of national cooperation on Market Surveillance activity:

SECTION 6 / 6: Contact details

Please include your contact details here below, and tick the appropriate box should you agree

to be contacted by telephone, in the week of 27

February, to follow up on your replies to this

survey:

Country:

Organisation Name:

Type of organisation:

MSA with national vs. local competences (delete accordingly)

Product specialised vs. cross-sectoral portfolio (delete accordingly)

Sectoral activity, if any (e.g., chemicals, transport):

Contact Person:

Position:

E-mail address:

Telephone number:

Yes, I accept to be contacted by telephone for a follow-up interview

No, I am not available to be contacted by telephone for a follow-up interview

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