kom (2018) 0697 - Ingen titel

Europaudvalget 2018
KOM (2018) 0697
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EUROPEAN

COMMISSION

Brussels, 17.10.2018

SWD(2018) 438 final

COMMISSION STAFF WORKING DOCUMENT

Synthesis Report on the Operation of Regulation (EU) No 649/2012 concerning the

export and import of hazardous chemicals

Accompanying the document

Report from the Commission to the European Parliament, the Council, the European

Economic and Social Committee and the Committee of the Regions

Summary of the Synthesis Report on the operation of Regulation (EU) No 649/2012

concerning the export and import of hazardous chemicals

{COM(2018) 697 final}

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Contents

INTRODUCTION..................................................................................................... 5

1.1

1.2

1.3

The PIC Regulation ....................................................................................... 5

The reporting exercise .................................................................................. 6

Methodology ................................................................................................ 6

1.3.1

1.3.2

1.3.3

1.3.4

Preparation of the Commission’s report

.............................................. 6

Implementation of the common format for reporting for Member

States in the form of a web-based questionnaire ................................. 7

Synthesis of Member States’ reporting

............................................... 8

Drafting the synthesis report and summary ........................................ 8

GOVERNANCE OF THE PIC REGULATION ................................................................... 9

2.1

Organisation of the implementation of the PIC Regulation ................................. 9

2.1.1

2.1.2

2.1.3

2.2

European Commission ...................................................................... 9

European Chemicals Agency (ECHA) .................................................. 9

DNAs ............................................................................................11

Coordination between the Commission, the Agency and Designated National

Authorities..................................................................................................14

2.2.1

2.2.2

2.2.3

Coordination between DNAs and the Commission ...............................14

Coordination between DNAs and the Agency ......................................14

Coordination between the Agency and the Commission .......................14

Coordination of Union input to the Conference of the Parties (CoP) .......16

Participation in committees and expert groups ...................................16

Financial contributions to the Rotterdam Convention ...........................17

2.3

The EU as a Party to the Rotterdam Convention ..............................................15

2.3.1

2.3.2

2.3.3

UPDATES OF ANNEX I AND ANNEX V TO THE PIC REGULATION ..................................18

3.1

3.2

Update of Annex I .......................................................................................18

Updates of Annex V .....................................................................................20

OPERATION OF THE PIC REGULATION .....................................................................21

4.1

Support to exporters and importers ...............................................................21

4.1.1

4.1.2

4.2

4.2.1

4.2.2

4.2.3

4.2.4

4.2.5

4.2.6

4.2.7

4.3

4.4

4.5

4.6

4.7

Support provided by DNAs ...............................................................21

Support provided by the Agency .......................................................22

Export notifications processed during the reporting period ...................25

Special RIN requests processed during the reporting period .................26

Requests for resubmission and rejection of export notifications ............27

Difficulties encountered in the export notification procedure ................29

Emergency situations (Article 8(5)) ..................................................31

Provision of available additional information on exported chemicals ......32

Administrative fee for export notifications ..........................................32

Export notifications forwarded to Parties and other countries (Article 8) .............24

Export notifications from Parties and other countries (Article 9) ........................32

Information on export and import of chemicals (Article 10)...............................33

Notification of banned or severely restricted chemicals under the Convention

(Article 11-12) ............................................................................................33

Obligations in relation to importing chemicals (Article 13) ................................34

Obligations in relation to exports of chemicals, other than export notifications

(Article 14) .................................................................................................35

4.7.1

4.7.2

Communication of information and decisions to those concerned

within the jurisdiction of a Member State (Article 14(3)) .....................35

Explicit consent (Article 14(6)) .........................................................35

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4.7.3

4.7.4

4.8

4.9

4.10

Waivers (Article 14(6) and (7)) ........................................................37

Validity of explicit consent (Article 14(8)) ..........................................38

Information on transit movement (Article 16) .................................................39

Requirements linked to exported chemicals and accompanying information

(Article 17) .................................................................................................39

Enforcement of Regulation (EU) No 649/2012 (Article 18) ................................40

4.10.1

4.10.2

4.10.3

4.10.4

4.10.5

4.10.6

4.10.7

4.10.8

National enforcement authorities (NEAs) ...........................................40

Training inspectors .........................................................................41

Enforcement strategy......................................................................41

Enforcement activities .....................................................................42

Enforcement actions and penalty systems .........................................44

Infringements during the reporting period .........................................44

Collaboration between DNAs and NEAs ..............................................46

Forum activities .............................................................................47

4.11

4.12

4.13

Exchange of information (Article 20) ..............................................................48

Technical assistance (Article 21)....................................................................49

IT-related aspects .......................................................................................50

4.13.1

4.13.2

4.13.3

4.13.4

The ePIC system ............................................................................51

User-friendliness of the ePIC system .................................................52

Areas of improvement .....................................................................54

Data dissemination .........................................................................54

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Abbreviations used

BPR

CLP

CoP

CRC

CUS

DNA

ECHA

ePIC

FRA

NEA

OECD

PIC

POPs

PPPR

REACH

RIN

SAICM

SDS

Biocidal Products Regulation

Classification, Labelling and Packaging Regulation

Combined Nomenclature

Conference of the Parties to the Rotterdam Convention

Chemical Review Committee of the Rotterdam Convention

Customs Union and Statistics

Designated National Authority

European Chemicals Agency

Software application for implementation of Regulation (EU) No 649/2012

European Union

Final Regulatory Action

National Enforcement Authority

Organisation for Economic Cooperation and Development

Prior Informed Consent

Persistent Organic Pollutants

Plant Protection Products Regulation

Rotterdam Convention

Registration, Evaluation, Authorisation and Restriction of Chemicals

Regulation

Reference Identification Number

Strategic Approach to International Chemicals Management

Safety Data Sheet

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1 I

NTRODUCTION

1.1 The PIC Regulation

Regulation (EU) No 649/2012

(‘the PIC Regulation’)

implements the Rotterdam

Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous

Chemicals and Pesticides in International Trade, adopted in 1998 and ratified by the EU

in 2002. The Regulation aims to promote shared responsibility and cooperation in the

international movement of hazardous chemicals, and to protect human health and the

environment from potential harm by facilitating the exchange of information concerning

the characteristics of hazardous chemicals, providing for a decision-making process

within the EU on the import and export of such chemicals, and disseminating decisions

to Parties to the Convention and other countries (Article 1).

The PIC Regulation applies to chemicals subject to the PIC procedure under the

Rotterdam Convention, as well as to industrial chemicals (used by professionals and

consumers) and pesticides (including biocides) that are banned or severely restricted by

EU legislation for health or environmental reasons. The Regulation places obligations on

companies intending to export such chemicals to third countries, whether or not they

are Parties to the Rotterdam Convention. Exports are subject to different requirements

depending on their listing in Annex I to the Regulation: chemicals listed in Part 1 of

Annex I are subject to export notification to the authority of the importing country;

chemicals listed in Parts 2 and 3 of Annex I are subject to export notification and explicit

consent of the authority of the importing country, unless they are subject to the PIC

procedure under the Convention and exported to a Party that has provided a positive

import response, or to a country that has waived its right to be notified. These

obligations also apply to mixtures containing substances listed in Annex I to the

Regulation in concentrations that trigger labelling obligations under the Classification,

Labelling and Packaging Regulation (EC) No 1272/2008

(CLP Regulation), and to

articles containing substances listed in Parts 2 or 3 of Annex I in unreacted form, or

mixtures containing substances listed in Parts 2 or 3 of Annex I in concentrations that

trigger labelling obligations under the CLP Regulation.

The PIC Regulation also places obligations on the Commission to notify the Secretariat of

the Convention of Final Regulatory Action (FRA) on chemicals that are banned or

severely restricted through FRA in the EU in one use category of the Convention

(industrial chemicals or pesticides) and which are listed in Part 2 of Annex I of the PIC

Regulation, as well as to inform other Parties about their potential risks and allow them

to consider whether or not risk management measures are needed in their own

territories. This process is known as the FRA notification and is the basis for the listing of

chemicals in Annex III to the Convention.

For chemicals that are listed in Part 3 of Annex I (which reflects Annex III to the

Convention), the Commission, in close cooperation with the Member States, decides if

the chemical can be imported in the EU and under which conditions. This is done

through an import decision, which is then sent to the Secretariat of the Convention.

Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the

export and import of hazardous chemicals, OJ L 201, 27.7.2012, pp. 60–106.

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, OJ L 353, 31.12.2008, pp. 1–

1355.

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1.2 The reporting exercise

Article 22 of the PIC Regulation requires the Commission to report on its activities under

the Regulation every three years, and to compile a synthesis report on the performance

of the PIC Regulation, integrating the following:



The information submitted by Member States as per Article 22(1), concerning the

operation of the procedures provided for in this Regulation, including customs’

controls, infringements, penalties and remedial action.

The information submitted by the European Chemicals Agency (ECHA) as per

Article 22(1), concerning the operation of the PIC Regulation’s procedures.

This reporting exercise is the first under the new PIC Regulation. It covers the three

years of implementation since the Regulation became applicable (2014

-2016). A

common reporting format for Designated National Authorities (DNAs) was established by

Commission Implementing Decision (EU) 2016/770 of 14 April 2016

, in order to collect

consistent information across Member States. Similarly, a reporting format for the

Agency’s report was adopted through Commission Implementing Decision (EU)

2016/1115 of 7 July 2016

Although the Member States and the Agency were required to report by 31 May 2017,

the reporting process encountered some delays. The report from the Agency was

received on 18 July 2017, while the Member States’ reporting was completed on 5

October 2017, when the final reporting questionnaire was submitted.

The present report is the synthesis report (as per Article 22 of the PIC Regulation),

bringing together the findings from the reports of the Commission, the Agency’s, and

Member States. It provides an overview of the implementation of the PIC Regulation in

the period 2014-2016.

1.3 Methodology

1.3.1

Preparation of the Commission’s report

The report is divided into two sections, the first addressing the work of the Commission

with respect to implementation within the EU, and the second addressing the

international work of the Commission as the EU DNA to the Rotterdam Convention.

Additional relevant information was compiled from EUR-lex, the website of the

Rotterdam Convention, and documents published on CIRCABC, including minutes of

meetings, and other documents discussed at DNA meetings (see Table 1). Other

information was obtained first-hand from Commission officials. Sources used for this

report are listed in Table 1 below. The report was then used as a source for the

synthesis report.

Regulation (EU) No 649/2012 applied from 1 March 2014.

Commission Implementing Decision (EU) 2016/770 of 14 April 2016 establishing a common format for the

submission of information concerning the operation of the procedures pursuant to Regulation (EU) No

649/2012 of the European Parliament and of the Council concerning the export and import of hazardous

chemicals, C/2016/2068, OJ L 127, 18.5.2016, pp. 32–51.

Commission Implementing Decision (EU) 2016/1115 of 7 July 2016 establishing a format for the submission

by the European Chemicals Agency of information concerning the operation of the procedures pursuant to

Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and

import of hazardous chemicals, C/2016/4141, OJ L 186, 9.7.2016, pp. 13–23.

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Table 1: List of relevant documents consulted for the Commission report

List of relevant documents consulted

Implementing and delegated acts



Commission Delegated Regulation (EU) No 1078/2014 amending Annex I to the PIC Regulation.

Commission Delegated Regulation (EU) 2015/2229 amending Annex I to the PIC Regulation.

Commission Implementing Decision of 11 February 2016 adopting Union import decisions

(2016/C 61/06).

Commission Implementing Decision of 15 May 2014 adopting Union import decisions (2014/C

152/02).

Commission Implementing Decision of 14 April 2016 establishing a common format for the

submission of information concerning the operation of the procedures pursuant to Regulation

(EU) No 649/2012 of the European Parliament and of the Council concerning the export and

import of hazardous chemicals.

Commission Implementing Decision of 7 July 2016 establishing a format for the submission by

the European Chemicals Agency of information concerning the operation of the procedures

pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council

concerning the export and import of hazardous chemicals.

Minutes of 23

, 24

, 25

, 26

, 27

and 28

DNA meetings.

Amendments to Annex I to Regulation (EU) No 649/2012 presented at 23

, 24

, 25

, 26

, 27

and 28

DNA meetings.

Import decisions presented at 23

, 24

, and 26

DNA meetings.

Submission of notifications to the PIC secretariat presented at 23

, 24

, 25

, 26

, 27

and 28

DNA meetings.

Implementation issues presented at 23

, 24

, 25

, 26

, 27

and 28

DNA meetings.

Documents on the preparation of COP 7 and 8 presented at 25

, 26

and 28

DNA meetings.

PIC circulars published by the Rotterdam Convention.



DNA meeting documents



Rotterdam Convention documents

1.3.2 Implementation of the common format for reporting for

Member States in the form of a web-based questionnaire

The common reporting format was made available online to Member States on 2

February 2017, through EU Survey. A guidance document for Member States

accompanied the invitation email. The project team was also available to answer DNA

questions on EU Survey and/or the reporting format, as well as supporting the DNAs in

submitting their questionnaires.

To facilitate Member State reporting, the Agency has made data from ePIC available to

DNAs for the following questions:



Section 2 - Question 10: number of export notifications and Special RIN requests

accepted by DNA and forwarded to the Agency.



Section 5 - Question 20: number of export notifications sent back to the exporter

either to request resubmission or because the notification was rejected.



Section 7 - Question 40: number of requests for explicit consent and number of

responses received per year.



Section 7 - Question 43: number of cases where DNA had to decide if no explicit

consent was required in case of chemicals listed in Part 2 of Annex I to be

exported to OECD countries.



Section 7 - Question 45: number of waiver requests received by DNAs.



Section 7 - Question 47: number of cases where the export was allowed to

proceed pending a reply to a new request for explicit consent.

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For consistency, the data provided by the Agency were used for these questions, even

where the data provided by the Member States differed from that data sent by the

Agency.

1.3.3

Synthesis of Member States’ reporting

Once all Member States had returned their reporting questionnaires, the full dataset and

statistics were downloaded in excel format from EU Survey. The information provided by

the DNAs was compiled and summarised for each question and presented visually,

where relevant. The full set of DNA responses is available in Annex II.

1.3.4 Drafting the synthesis report and summary

The synthesis report combines the information from the Commission report, the Member

States’ reporting questionnaires and the Agency’s questionnaire.

It follows the structure

of the common Member States’ reporting questionnaire and the questionnaire for the

Agency’s reporting, integrating the information from the Commission report, where

relevant. The summary follows the same structure as that of the synthesis report,

presenting the key facts and conclusions from each section.

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2 G

OVERNANCE OF THE

PIC R

EGULATION

2.1 Organisation of the implementation of the PIC Regulation

2.1.1 European Commission

The Commission, in cooperation with the Member States, is responsible for policy work

under the PIC Regulation, in particular the adoption of amendments to Annexes I and V

to the Regulation. In addition, the Commission is responsible for the legal interpretation

of the Regulation, and representation of the Union in the Convention and towards non-

EU Parties, which includes acting as a common designated authority for the

administrative functions of the Convention with respect to the PIC procedure (see

Section 2.3). The Commission also chairs the DNA meetings that occur twice a year,

normally in April and October.

DG Environment takes charge of the PIC Regulation. Unit B.2

–

sustainable chemicals

has one policy coordinator responsible for implementation of the PIC Regulation,

including policy and legal matters and international cooperation and representation. The

policy coordinator is supported by a lawyer for legal questions, and by a secretary for all

organisational work. For international work, Unit B.2 has one expert (the policy

coordinator) who was nominated to the Convention bodies, i.e. the Chemical Review

Committee (CRC) and the intersessional working group on the process of listing

chemicals in Annex III to the Convention. In addition, colleagues of Unit F.3, which is

responsible for multilateral environmental cooperation, contribute to the international

work, particularly in the context of the CoP, by dealing with horizontal and cross-cutting

matters such as financial resources, budget, technical assistance and some legal

matters. The staff resources occupied by this work amount to 0.4 FTE for the policy

coordinator and 0.4 FTE for the supporting work, including international matters.

2.1.2 European Chemicals Agency (Agency)

The Agency plays a central role in ensuring that the export notification procedure

functions properly, as well as developing and operating the application to process export

notifications and the explicit consent given by the importing countries (ePIC). More

specifically, the tasks of the Agency include:



Registering the export notifications established by the exporters and sent by EU

DNAs, assigning them a Reference Identification Number (RIN), checking their

completeness and forwarding them to the DNA of the importing country (Article

8(2).



Sending a second export notification if the Agency does not receive an

acknowledgement of receipt from the authority in the non-EU country within 30

days of the first notice (Article 8(3)).



Making available to all EU DNAs export notifications received from third country

DNAs (Article 9(1)).



Acknowledging receipt of export notifications received from non-EU countries

(Article 9(1)).



Sending a reminder for an explicit consent request if no response is received

from the authorities in the non-EU country within 30 days of the initial request;

sending a second reminder after a further 30 days if a response is still

outstanding (Article 14(6)).



Managing ePIC and keeping all relevant document available on the platform;



Supporting the EU DNAs and the European Commission in assessing waivers

pursuant to Article 14(6) and 14(7).



Aggregating and summarising the data received each year from DNAs on the

quantities of exported and imported chemicals, and making non-confidential

information publicly available (Article 10(3)).

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

Every two years, compiling and publishing the information transmitted by the

Commission, the Member States and the Agency to the authorities in third

countries on the chemicals subject to the Regulation.

The Agency’s Secretariat of the Forum for Exchange of Information on

Enforcement established by the REACH Regulation also provides coordination and

support to discussions related to PIC (Article 18(2)).

Participate in the twice-yearly DNA meetings organised by the Commission and

provide updates on the operations and opinions of relevant documents discussed

at these meetings.

In addition, the Agency provides assistance and technical and scientific guidance to

industry, the DNAs from Member States and third countries, and the European

Commission (Article 6).

Resources dedicated by the Agency to the operation of the PIC Regulation have

remained stable over the reporting period (see Table 2).

Table 2:

Agency’s staff working on the PIC Regulation

Number of staff working on PIC (FTE)

2014

2015

2016

The Agency’s staff working on PIC also collaborate with the staff working on other EU

regulations for which the Agency is responsible, i.e. REACH, CLP and the Biocidal

Products Regulation (BPR), where there are synergies with processes that run across the

various pieces of legislation. For example, the Agency’s staff collaborate on:



Development and maintenance of ePIC in order to benefit from synergies

between all the Agency’s IT tools concerning login and account management;



Support to (Article 8(2) stakeholders;



Substance identity check of substances added to the PIC Regulation;



Publication of data on the Agency’s website;



Safety Data Sheet (SDS) checks (e.g. inaccuracies in defining the concentration

of a substance, a mixture composition, doubts about classification, etc.);



Support to the Commission in drafting FRA notifications submitted to the

Rotterdam Convention Secretariat;



Support to the Commission and the Member States by the presence of a nominee

on the CRC;



Drafting guidance for the implementation of the PIC Regulation;



Legal advice;



Communications;



Human resources.

The Agency’s workload during the reporting period was higher than

predicted before the

entry into force of the Regulation. As highlighted in its report, the number of export

notifications increased beyond the predicted 10% yearly increase (see Table 3), which

led to an increase in processing tasks to be performed by the Agency and thus the time

spent on supporting DNAs (from EU and non-EU countries), which takes 30-40% of staff

time. The increase in export notifications also made additional improvements of ePIC

necessary (e.g. increasing the automation of certain processes to reduce the workload

for industry users and authorities and enable them to meet legal deadlines), and caused

more requests for support from the Agency (see Table 4).

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Table 3: No. of export notifications predicted vs. processed by the Agency

2014

No. of estimated notifications

Actual no. of notifications

4,000

4,575

2015

4,300

5,460

2016

6,300

7,967

Table 4: No. of requests for technical/regulatory support from the Agency

No. of requests

regulatory support

for

technical/

2014

1,000

2015

1,500

2016

1,800

As the distribution of work is uneven during the calendar year, peaking during the winter

months, the Agency reported regularly hiring interim staff for several months every year

to meet the increased need.

2.1.3 DNAs

Member States play a major role in the application, implementation, and enforcement of

the PIC Regulation. As per Article 4 of the PIC Regulation, Member States must

designate one or several authorities to carry out the administrative functions required by

the Regulation. A total of 35 authorities have been designated by Member States. Article

18 of the PIC Regulation also requires Member States to designate enforcement

authorities, such as customs authorities (see Section 4.10).

The responsibilities of the Member States are largely discharged by DNAs and can be

divided in four categories: administrative tasks, enforcement, monitoring and reporting,

and exchange of information

Administrative tasks



Check compliance of export notifications with Annex II and forward these to the

Agency (Article 8(2)).



Request explicit consent from the DNA/appropriate authority of the importing

country for the export of the chemicals listed in Parts 2 and 3 of Annex I. In the

case of export of Annex I Part 2 chemicals to OECD countries, decide (in

consultation with the Commission) if the requirement for explicit consent may be

waived on the basis of the chemical being licensed, registered or authorised in

the OECD country concerned (Article 14(6)).



Consult the Commission and take decisions on the granting of a waiver for the

export of chemicals listed in Parts 2 and 3 of Annex I in cases where no response

is received within 60 days of a request for explicit consent (Article 14(7)).



Assist the Commission in its periodic review of explicit consents and waivers

(Article 14(8)).



Forward export notifications received from third countries to the Agency (Article 9

(2)).



Provide the Commission with sufficient information on FRA to ban or severely

restrict a chemical at national level and consider any comments received from

other Member States (Article 11(8)).



Inform the Commission of national regulatory actions related to PIC chemicals so

that this information can be taken into account in EU import decisions (Article

13(2)) and make EU import decisions available to those concerned within their

competence (Article 13(5)).

Adapted from: ECHA,

Guidance for implementation of Regulation (EU) No 649/2012 concerning the export

and import of hazardous chemicals,

version 1.1, 2015.

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

Forward information on chemicals subject to the PIC procedure and on decisions

of importing parties regarding import conditions applicable to those chemicals to

those concerned within its jurisdiction (Article 14(3) in conjunction with Article

14(1)).

Handle Special RIN requests.

Participate in twice-yearly DNA meetings organised by the Commission, and

provide opinions on relevant documents discussed at these meetings.

Enforcement



Ensure that exporters meet their obligations, in particular those relating to

Articles 8, 10, 14, 15 and 17.



Take measures to ensure compliance, including the establishment of penalties for

infringements (Article 28).



Participate in the activities of the Forum for Exchange of Information on

Enforcement related to the PIC Regulation (Article 18(2)).

Monitoring and reporting



Provide the Agency with annual aggregated reports on trade in chemicals listed in

Annex I (Article 10(3)).



Every three years, provide the Commission with information on the operation of

the PIC Regulation (Article 22).

Provision and exchange of information



Provide importing countries with additional information relating to exported

chemicals, on request (Article 8(7)).



Assist the Commission in compiling additional information with respect to FRA

notifications, on request (Article 11(6)).



Where requested, advise and assist importing countries to obtain additional

information to help them with an import response for PIC chemicals (Article

14(5)).



Forward to the Commission (with a copy to the Agency) any information required

by an importing Party to the Convention that has been provided by the exporter

concerned prior to each transit movement of a chemical listed in Part 3 of Annex

I (Article 16(3)).



Facilitate the exchange of information (Article 20) and cooperate in the

promotion of technical assistance (Article 21).

Most Member States (22) have only one DNA, while six have two or three (Table 5).

DNAs are mostly Ministries or agencies responsible for environment, chemicals, and

health or health and safety. In a few cases, the Ministries responsible for economy,

competition, labour or agriculture have been designated as competent authorities. In the

Netherlands, the customs authority is the only DNA.

Table 5: Distribution of responsibilities across DNAs in Member States with more than one DNA

Member States

Greece

Distribution of responsibilities

Directorate of Energy, Industrial and Chemical Products, General

Chemical State Laboratory: responsible for industrial chemicals

Department of Plant Protection Products and Biocides, Ministry of

Rural Development and Food: responsible for pesticides

Ministry of Human Capacities: responsible for industrial chemicals

National Food Chain Safety Office: responsible for pesticides

The Health and Safety Authority: DNA for industrial chemicals

The Revenue Commissioners: solely for the purposes of Article 18

of the PIC Regulation

The Minister for Agriculture, Food and the Marine: responsible for

pesticides (other than for the purposes of Article 18 of the

Rotterdam Regulation)

Hungary

Ireland

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Member States

Latvia

Distribution of responsibilities

Latvian Environment, Geology and Meteorology Centre: responsible

for industrial chemicals

State Plant Protection Service: responsible for pesticides

Ministry of Economy: responsible for industrial chemicals

Ministry of Agriculture and Rural Development: responsible for

pesticides

Health and Safety Executive: DNA for Great Britain

Health and Safety Executive Northern Ireland: DNA for Northern

Ireland

Slovakia

Although the UK officially has two DNAs, through an agreement between Great Britain

and Northern Ireland, all of the UK DNA work is carried out by the Health and Safety

Executive.

In Member States with more than one DNA, responsibilities are generally divided, with

one DNA responsible for industrial chemicals while another is responsible for pesticides.

Table 5 provides information on the distribution of responsibilities among those Member

States with several DNAs.

With the exception of the Netherlands, DNAs in all other Member States are involved in

the implementation of other EU or international chemicals management instruments,

such as legislation, conventions or programmes (see Figure 1). Twenty DNAs (in 19

Member States) are also responsible for the implementation of the REACH Regulation,

21 DNAs (in 20 Member States) for CLP, 15 for the BPR and 8 for the PPPR. In eight

Member States, the DNAs are also involved in the implementation of the Stockholm

Convention.

The resources needed to implement the PIC Regulation in Member States, in particular

the human resources, largely depend on the number of export notifications and requests

for explicit consent that are processed. The figures provided by Member States for

human resources working on PIC in the DNAs vary between 0.1 FTE for those Member

States with few or no export notifications to process, and 2 FTE for those Member States

with the highest numbers of export notifications.

Figure 1: Other EU legislation for which PIC DNAs are also responsible

CLP

REACH

BPR

PPPR

Detergents Regulation

POPs Regulation

Ozone depleting substances Regulation

Number of DNAs

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2.2 Coordination between the Commission, the Agency and Designated

National Authorities

2.2.1 Coordination between DNAs and the Commission

All Member States considered the coordination between the DNAs and the Commission

to be satisfactory. Three Member States mentioned that the regular DNA meetings are

an important coordination mechanism, and seven indicated that the support provided by

the Commission to DNAs (especially answers to DNA questions) is quick and of good

quality.

According to the DNAs, the update of annexes (Article 23) and the obligation to monitor

exporters’ compliance (Article 18(1)) are areas that could still be improved. Several

DNAs also mentioned that relevant documents should be made available in due time

before DNA meetings.

For its part, the Commission also considered the cooperation with DNAs to be

satisfactory. There have been regular exchanges during the reporting period on

scientific, technical and legal questions arising in the context of implementation, in

particular through discussions at the twice-yearly PIC DNA meetings. The Commission

also coordinates and consults with DNAs on any submissions to the Secretariat of the

Rotterdam Convention.

2.2.2 Coordination between DNAs and the Agency

All Member States considered the coordination between the DNAs and the Agency to be

satisfactory. Eight Member States specified that the assistance provided by the Agency

to DNAs is valued for its swiftness and quality.

The main areas of improvement, according to the DNAs, are the updating of annexes

(Article 23), followed by technical assistance (Article 21), and the provision of additional

information on exported chemicals, on request (Article 8(7)).

According to the Agency, the collaboration with DNAs is also satisfactory. It indicated

that collaboration with DNAs is efficient and friendly, including when handling

disagreements. Cooperation could be improved, however, regarding the implementation

of Article 8(2) on the timelines for processing export notifications, Article 8(5) on export

in case of an emergency situation, Article 14(6) on substances that cannot be exported

unless certain conditions are fulfilled, and Article 14(6) and (7) on decisions that the

export can proceed in the absence of an explicit consent.

2.2.3 Coordination between the Agency and the Commission

The Commission considered cooperation with the Agency to be satisfactory, as there

were regular exchanges on scientific, technical and legal questions arising in the context

of implementation, in particular on the legal interpretation of provisions and their

practical implementation. The Agency participated in all DNA meetings to report on the

work done in the area of implementation. The Commission contributed to the

development of the guidance produced by the Agency, as well as to the work of the

Forum on Exchange of Information on Enforcement.

Regarding the cooperation with third countries and the Secretariat of the Rotterdam

Convention, the Commission and the Agency have closely coordinated their activities to

ensure that the most appropriate and effective assistance is provided and that resources

are used efficiently.

According to the Agency, coordination with the Commission is generally satisfactory. It

did, however, point to the following areas which could be improved:

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

Preparation of FRA notifications to the Rotterdam Convention

Secretariat:

In some cases, tasks have been assigned with a short deadline and

without advance warning. Increased predictability and common planning would

help the Agency to ensure timely development of good quality notifications.

Technical preparation of meetings:

the Agency mentioned that documents

are often sent by the Commission for checking/drafting with very short deadlines,

making it difficult for the Agency to produce high-quality documents. Preparation

for the meetings could be improved by greater collaboration between the Agency

and the Commission/ Member State experts.

Article 14(6) and (7) on decisions that the export can proceed in the

absence of an explicit consent:

The Agency mentioned that there is a

relatively high number of cases in which they need to ask the Commission to

verify and subsequently amend/reject the decision (when relevant) due to clerical

errors (e.g. incorrect validity dates, missing translations of documents,

questionable supporting documentation). This slows down the process and, in

many cases, triggers requests for clarification from exporters. An enhanced role

for the Agency in this process could improve its efficiency and effectiveness.

Article 23 on updating annexes:

The Agency believes it would be beneficial for

it to be involved at an early stage in the adoption of amendments to the

Regulation. For example, it suggested checking the substance identity of

chemicals proposed for amendments to ensure consistency with processes under

the other legislations it manages. It also proposed that, based on Article 6(1)(f),

the Commission could consider asking for its support in identifying and proposing

further candidate substances for inclusion in the PIC Regulation. Finally, the

Agency would like to contribute to the planning of the entry into application of

amendments to the Regulation, in order to avoid co-occurrence with the annual

export notification peak in the winter.

Day-to-day exchanges between the Agency and the Commission:

According to the Agency, there is room for improvement in the timing of replies,

as delays create problems for the performance of its operational tasks.

2.3 The EU as a Party to the Rotterdam Convention

The Commission, as the EU DNA, is the main interface with the Secretariat of the

Convention. In particular, the Commission is responsible for:



Representation of the EU to the Rotterdam Convention.



Coordination of EU input on all technical issues related to the Convention, the

preparation of the CoP, the CRC and other subsidiary bodies of the CoP.



Submission to the Secretariat of relevant FRA notifications concerning chemicals

qualifying for PIC notification.



Transmission of information on other FRA involving chemicals not qualifying for

PIC notification.



Submission to the Secretariat of EU import responses for chemicals subject to the

PIC procedure.



Exchange of information with the Secretariat in general.

The Member States, as Parties to the Convention, also participate in the CoP, the CRC

and activities under the Convention, such as the intersessional working group on the

process of listing chemicals in Annex III to the Convention. The Member States and their

DNAs provide input to the EU position on matters discussed at the CoP. Some DNAs also

participate in technical assistance activities under the Convention, to which the Agency

also contributes.

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2.3.1 Coordination of Union input to the Conference of the Parties

(CoP)

The 7

Conference of the Parties to the Rotterdam Convention took place from 4 to 15

May 2015 (thus during the reporting period), back-to-back with the 12

CoP to the

Basel Convention and the 7

CoP to the Stockholm Convention.

Before CoP 7, the Commission prepared the draft position of the EU on matters

discussed at the meeting:



A proposal for a Council Decision establishing the EU position on amendments to

Annex III to the Convention, seeking a mandate for decision-making at the CoP.

This document was then discussed by the Council Working Party on International

Environmental Issues and by the Council Working Party on Environment, and

adopted by the Council on 6 March 2015.



A position paper, discussed with the Member States at the Council Working Party

on International Environmental Issues’ meetings, outlining the position to be

taken on the various items that would be discussed at the CoP. The final version

of this position paper was adopted in April 2015.



A position paper on budget and management issues covering the Rotterdam,

Basel and Stockholm Conventions, as the Programmes of Work and budgets of

the three Conventions were addressed in a joint session.



A position paper on technical assistance and financial issues, also covering each

of the Rotterdam, Basel and Stockholm Conventions.

After CoP 7, the Commission presented the outcomes of the CoP to DNAs at the 26

DNA meeting on 21 October 2015. The Commission also submitted, together with the

Presidency, an information note on the outcomes of the CoPs of the Rotterdam, Basel

and Stockholm Convention, transmitted by the General Secretariat of the Council to the

delegations on 10 June 2015. In addition, all of the statements made during the CoP on

behalf of the EU by the Commission and on behalf of the EU and its Member States by

the Presidency were published, together with the statements made at the 12

CoP to

the Basel Convention and the 7

CoP to the Stockholm Convention, through an

information note of the General Secretariat of the Council to delegations on 6 July 2015.

2.3.2 Participation in committees and expert groups

During the reporting period, the EU had five or six members nominated as experts in the

CRC, including two representatives in the bureau: Mr Jürgen Helbig from the

Commission, nominated by Spain, who acted as Chair for three meetings of the CRC

during the reporting period (October 2014, October 2015 and September 2016), and Ms

Magdalena Frydrych, nominated by Poland, acting as Vice-chair (see Table 6).

Table 6: EU Members of the CRC during the reporting period

CRC meetings

CRC-10, October 2014

CRC-11, October 2015

EU Members of the CRC

Ms Anja Bartels (Austria)

Ms Parvoleta Angelova Luleva (Bulgaria)

Ms Mirijam Seng (Germany)

Ms Leonarda Christina van Leeuwen (Netherlands)

Ms Magdalena Frydrych (Poland)

Mr Jürgen Helbig (Spain)

Ms Anja Bartels (Austria)

Ms Parvoleta Angelova Luleva (Bulgaria)

Ms Mirijam Seng (Germany)

Ms Leonarda Christina van Leeuwen (Netherlands)

Ms Magdalena Frydrych (Poland)

Mr Jürgen Helbig (Spain)

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CRC meetings

CRC-12, September 2016

EU Members of the CRC

Ms Parvoleta Angelova Luleva (Germany)

Ms Leonarda Christina van Leeuwen (Netherlands)

Ms Magdalena Frydrych (Poland)

Mr Jürgen Helbig (Spain)

Ms Johanna Peltola-Thies (UK)

Eight EU experts were also nominated to the intersessional working group on the

process of listing chemicals in Annex III to the Convention:



Mr Björn Hansen (European Commission)



Mr Jürgen Helbig (European Commission)



Ms Anja Bartels (Austria)



Ms Mara Curaba (Belgium)



Ms Jutta Emig (Germany)



Ms Silvija Nora Kalnins (Latvia)



Ms Magdalena Frydrych (Poland)



Mr Richard Vincent (UK)

2.3.3 Financial contributions to the Rotterdam Convention

As a Party to the Rotterdam Convention, the EU paid the mandatory contribution to the

Convention’s Trust Fund and also contributed to the Special Voluntary Trust Fund for the

implementation of the programme of work for technical assistance (see Table 7).

Table 7:

Financial contributions from the EU to the Rotterdam Convention’s Trust Fund and Special

Voluntary Trust Fund (EUR)

Year

2014

2015

2016

EU contribution to Trust Fund

51,195

55,474

54,582

EU contribution to Special Voluntary

Trust Fund

277,331

302,815

513,603

As all Member States are Parties to the Convention, they also contribute to the

Convention’s Trust Fund through their mandatory contributions to the budget of the

Convention adopted by the CoP. In addition, some Member States contribute to the

Special Voluntary Trust Fund (see Table 8).

Table 8:

Member States’ contributions to the Special Voluntary Trust Fund (EUR)

Member State

Finland

France

Germany

Netherlands

Sweden

2014

84,325

2015

79,900

5,000

20,000

70,000

23,000

2016

14,950

61,000

From the Rotterdam Convention website, amounts converted from USD to EUR at November 2017 rates.

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3 U

PDATES OF

NNEX

AND

NNEX

TO THE

PIC R

EGULATION

According to Article 23, the list of chemicals in Annex I should be reviewed at least once

a year by the Commission on the basis of the developments in EU law (mainly in the

REACH Regulation, the BPR and the PPPR) and under the Convention. Annexes to the

PIC Regulation are amended through delegated acts adopted by the Commission. Since

the procedure for adoption of delegated acts is rather new, the Commission explained at

the 23

and subsequent DNA meetings that it does not require the opinion of a

comitology committee but, rather, the consultation of an expert group. That consultation

is undertaken by presenting the draft amendment at the PIC DNA meeting and inviting

comments from all of the Member State experts present, together with other

stakeholders. In addition, the delegated act adopted by the Commission is submitted to

the European Parliament and the Council, and only enters into force if neither objects.

3.1 Update of Annex I

Amendments to Parts 1 and 2 of Annex I are triggered by regulatory actions changing

the legal status of a substance under other relevant EU legislation, in particular:



Decision not to approve or to withdraw an active substance under the PPPR;



Decision not to approve or to withdraw an active substance under the BPR;



Decision to subject a chemical to authorisation by adding it to the Authorisation

List (Annex XIV) of the REACH Regulation;



Decision to restrict the use of a chemical (Annex XVII) under the REACH

Regulation.

During the reporting period, two Delegated Regulations amending Annex I were

adopted, in 2014 and 2015 (see Table 9). Of the substances added to Annex I, many

were proposed for inclusion in Parts 1 and 2 of Annex I of the PIC Regulation having

been already banned for use as pesticides under Regulation (EC) No 1107/2009. This is

the case for bitertanol, cyhexatin, azocyclotin, cinidon-ethyl, cyclanilide, ethoxysulfuron,

oxadiargyl, didecyldimethylammonium chloride, and warfarin in 2014, and fenbutatin

oxide in 2015. In addition, substances severely restricted as pesticides, such as

rotenone and cyfluthrin, were added to Annex I in 2014.

Lead compounds, dibutyltin compounds, dioctyltin compounds, trichlorobenzene,

pentachloroethane,

1,1,2,2-tetrachloroethane,

1,1,1,2-tetrachloroethane,

1,1,2-

trichloroethane and 1,1-dichloroethene were added to Annex I in 2015, as these are

severely restricted as industrial chemicals for public use, in accordance with REACH.

Amendments to Part 3 of Annex I reflect the decision of the CoP to include certain

chemicals in Annex III of the Convention, making them subject to the PIC procedure.

Azinphos-methyl,

perfluorooctane

sulfonic

acid,

perfluorooctane

sulfonates,

perfluorooctane

sulfonamides

and

perfluorooctane

sulfonyls,

commercial

pentabromodiphenyl ether, including tetra- and pentabromodiphenyl ether, as well as

commercial octabromodiphenyl ether, including hexa- and heptabromodiphenyl ether

were included in Part 3 of Annex I during the reporting period, following their inclusion

in Annex III to the Rotterdam Convention.

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Table 9: Substances added to Annex 1 during the reporting period

Delegated Act

Commission

Delegated

Regulation

(EU)

No 1078/2014 of

7 August 2014

amending Annex I

to Regulation (EU)

No 649/2012

Chemical

Azocyclotin

Bitertanol

Cinidon-ethyl

Cyclanilide

Cyfluthrin

Cyhexatin

Ethoxysulfuron

Didecyldimethylammonium

Chloride

Oxadiargyl

Rotenone

Warfarin

Azinphos-methyl

Perfluorooctane sulfonic acid

Perfluorooctane sulfonates

Perfluorooctane sulfonamides

Perfluorooctane sulfonyls

1,1-Dichloroethene

1,1,2-Trichloroethane

1,1,1,2-Tetrachloroethane

1,1,2,2-Tetrachloroethane

Dibutyltin compounds

Dioctyltin compounds

Fenbutatin oxide

Lead compounds

Pentachloroethane

Trichlorobenzene

Commercial

pentabromodiphenyl ether,

including: tetrabromodiphenyl

ether, and pentabromodiphenyl

ether

Commercial octabromodiphenyl

ether, including

hexabromodiphenyl ether and

heptabromodiphenyl ether

Amendment

of Annex I

Part 1 and 2

Part 1and 2

Part 1 and 2

Part 1

Part

1 and 2

Basis

inclusion

PPPR

Annex III

REACH

PPPR

REACH

Annex III

for

Commission

Delegated

Regulation

(EU)

2015/2229 of 29

September 2015

amending Annex I

to Regulation (EU)

No 649/2012

to RC

Part 3

Annex III to RC

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The inclusion of other substances in Annex I was discussed in 2016, but has not yet

been formally adopted through a Delegated Regulation (see Table 10).

Table 10: Chemicals proposed for inclusion in Annex I

Chemical

Tepraloxydim

Carbendazim

Triflumuron

Triclosan

cybutryne

2,4-dinitrotoluene

4,4’-

diaminodiphenylmethane

(MDA)

5-tert-butyl-2,4,6-trinitro-

m-xylene

benzyl butyl phthalate

Diisobutyl phthalate

Diarsenic pentaoxide and

tris(2-chloroethyl)

phosphate

Methamidophos

Amendment of Annex I

Part 1 and 2

Part 1

Part 1 and 2

Basis for inclusion

PPPR

BPR

REACH

Part 1 and 2

REACH

Part 1 and 3

Annex III to RC

3.2 Updates of Annex V

At the 27

meeting of the DNAs in April 2016, an amendment to Annex V was discussed

–

the inclusion of hexabromocyclododecane in Part 1 of Annex V of the PIC Regulation.

Hexabromocyclododecane has been included in Part A of Annex I to Regulation (EC) No

850/2004 (Persistent Organic Pollutants (POPs) Regulation), since the decision was

taken under the Stockholm Convention to list this chemical in Part 1 of Annex A to the

Stockholm Convention. It should therefore be listed in Annex V of the PIC Regulation.

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4 O

PERATION OF THE

PIC R

EGULATION

4.1 Support to exporters and importers

The Agency is required to provide assistance, as well as technical and scientific guidance

and tools, to exporters and importers (Article 6(1)). Although it is not a legal obligation

under the PIC Regulation, most DNAs have provided support and carried out awareness-

raising activities for national exporters and importers during the reporting period.

Both the Agency and Member States were asked to provide information (in their

respective reporting questionnaires) on the awareness-raising and communication

activities carried out during the reporting period and requests received from exporters

and importers (Section 3 of Member State and the Agency’s questionnaires).

Both DNAs and the Agency stated that the support provided to companies, as well as

the awareness-raising activities carried out during the reporting period, had improved

exporter and importer compliance with the PIC Regulation.

4.1.1 Support provided by DNAs

Awareness-raising activities

Twenty-five Member States stated that they had carried out awareness-raising and

information activities for exporters and importers during the reporting period (see Figure

2). Member States that did not carry out any such activities were either small Member

States with little or no exports and imports falling within the scope of the Regulation, or

Member States providing information to exporters and importers on request.

The most common activities carried out by Member States were the provision of online

information, such as a specific webpage providing information on the PIC Regulation,

and references to the Agency’s webpages on PIC and ePIC. Ten Member

States also

provide a national helpdesk.

Other awareness-raising activities carried out by Member States included mail or

telephone correspondence between the DNA and importers or exporters, guidelines for

importers and exporters, and information spread through the Strategic Approach to

International Chemicals Management (SAICM) Platform.

Almost all of the Member States carrying out awareness-raising and information

provision activities considered such activities to have improved exporter and importer

compliance with the PIC Regulation. For example, some DNAs noted an increase in the

number of export notifications received by the DNA during the reporting period, an

increase in the number of companies registered in ePIC, or improved compliance with

the Article 10 reporting obligations.

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Figure 2: Question 11. Have any awareness-raising and information activities been put in place by

the DNA(s) to support exporters and importers to comply with the PIC Regulation?

Spe ifi

e page pro idi g i for atio o the PIC…

Reference to ECHA webpages on PIC and ePIC

National helpdesk

Specific email address for information requirements

Workshops and similar training events

Others

O li e te h i al a d s ie tifi guida e (other tha …

Awareness-raising campaign

Visits to operator establishments

Social media

Number of Member States

Requests from exporters and importers

The most frequent requests from exporters and importers to DNAs relate to export

notifications and explicit consents (see Figure 3).

Estimated amount of time spent on support

In the majority of Member States, providing support to exporters and importers takes

less than 10% of the DNA’s working time. This rises to 40% in three Member States.

Figure 3: Question 13. On which matters do(es) the DNA(s) get the two most frequent requests for

support coming from exporters and importers?

Export notification

Explicit consent

Special RIN

Article 10 reporting

Others

Waiver

Number of Member States

4.1.2 Support provided by the Agency

Awareness-raising activities

The Agency has fulfilled its obligations under Article 6 of the PIC Regulation through the

following activities:

Technical and scientific guidance

The Agency published version 1.0 of the

Guidance for implementation of Regulation (EU)

No 649/2012 concerning the export and import of hazardous

chemicals (‘Guidance on

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PIC’) in December 2014 (in English only) and a corrigendum to it (version 1.1) in July

2015 (to take into account the end of certain CLP transition periods). Translations of

version 1.1 into 14 languages (Bulgarian, Croatian, Czech, Danish, Dutch, German,

Finnish, French, Spanish, Italian, Polish, Portuguese, Slovenian and Swedish) were

published in March 2016, with translations into the remaining eight official EU languages

(Estonian, Greek, Hungarian, Latvian, Lithuanian, Maltese, Romanian and Slovak)

published in October 2016.

Webpages on the PIC Regulation and ePIC

The

Agency

has

created

specific

webpage

the

PIC

Regulation

(https://echa.europa.eu/regulations/prior-informed-consent-regulation)

and a webpage

dedicated to ePIC (https://echa.europa.eu/support/dossier-submission-tools/epic). These

pages are in all official EU languages.

Internal messaging in ePIC

The communication via messages sent in ePIC is typically used in the following cases:



To remind exporters/importers of upcoming legal deadlines;



To advertise publication of updated user manuals, new factsheets, etc.;



To inform of policy changes;



To alert users in advance of maintenance breaks.

Awareness-raising campaign

The Agency reminds exporters and importers of PIC-related news, such as upcoming

legal deadlines or workload peaks, using different communication means, including the

weekly e-News and the Agency Newsletter. These channels are also used to highlight

new substances added to Annex I or included in group entries.

Support to individual companies

This is done through replies to Helpdesk incidents and/or telephone support.

Workshops, webinars and similar training events

The Agency has organised a number of workshops on PIC, mainly related to the initial

development of ePIC:



Three workshops for Member States and industry representatives organised at

the Agency’s premises during

the development of ePIC (June 2013, November

2013 and May 2014) in order to gather their feedback and invite their

contributions to the application specifications.



WebEx discussions during the development of the ePIC system.



Training workshop organised

at the Agency’s premises in September 2014, just

after the launch of the ePIC system, to instruct users on the use of ePIC

application.

In addition, the Agency takes part in conferences and training, seeing them as an

opportunity to reach out to industry directly, to provide updates on ePIC and policy

issues, and to address specific concerns.

IT user manuals, factsheets and Q&A (FAQs)

After the launch of ePIC, the Agency published a user manual, which was subsequently

translated into all official EU languages and is updated every time there is a new release

of the application. The Agency has also prepared factsheets dedicated to specific topics

and has a Q&A document on ePIC, which is updated in parallel with new releases of the

application.

According to the Agency, these activities have improved exporter and importer

compliance with the PIC Regulation. Similarly, it partially attributes the increase in the

number of companies registered in ePIC (390 in March 2014 compared to 1177 at the

end of the reporting period) to the awareness-raising activities and the visibility given to

ePIC.

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Requests from exporters and importers

Through its helpdesk, the Agency received 123 requests for information or support from

exporters and importers in 2014, 245 in 2015 and 227 in 2016.

The largest number of requests from exporters and importers’ concerned:



Scope-related issues: which chemicals are subject to the PIC Regulation;



Reasons why an export has not been allowed to proceed;



Exporters’ obligations under the

PIC Regulation, as determined by the listing of a

chemical in Annex I;



Clarification on which Member State shall receive the export notification (e.g.

where the legal entity holding the contract for an export is in one Member State

but the shipment is leaving from a different Member State);



Article 10 on the reporting required of exporters and importers during the first

quarter of each calendar year.

In addition, the Agency received a low number of more complex questions, e.g. the link

between the PIC Regulation and other legislation, the triggering of labelling obligations

for mixtures under CLP, or the responsibility for the export notification when the

manufacturer is based outside the EU but chemicals are shipped from the EU to third

countries.

Estimated amount of time spent on such support

Four FTEs working in the Dossier Submission & PIC Unit provide replies to the requests

received from companies. This task takes approximately 10% of their time, on average.

4.2 Export notifications forwarded to Parties and other countries

(Article 8)

The export notification is the instrument under the PIC Regulation by which countries

exchange information on banned or severely restricted chemicals. All EU based

exporters must submit an export notification to their DNA if they intend to export

chemicals listed in Part 1 of Annex I to the PIC Regulation to a third country (Party or

non-Party to the Rotterdam Convention), irrespective of the use of the chemical in the

country of destination. Once the DNA has checked and accepted the notification (after

resubmission if necessary), it is forwarded to the Agency, which also verifies the

compliance of the notification and transmits it to the DNA of the importing country. If no

acknowledgement of receipt is received, the Agency re-sends the notification. The whole

procedure is carried out by means of ePIC, and exporters must use the notification

template provided by the system.

DNAs and the Agency were asked to provide data on the number of export notifications

and Special RIN requests processed during the reporting period, information on

difficulties encountered by exporters and authorities in carrying out the procedures,

emergency situations, and the provision of additional information on exported chemicals.

The number of export notifications and Special RIN requests increased between 2014

and 2016, and their number varied significantly between Member States. According to

the Agency, this shows that compliance has increased during the reporting period. In a

relatively high number of cases, the DNAs or the Agency requested resubmission of a

notification, usually relating to issues with section 6 of the notification form (summary

of, and reasons for, the FRA and date of entry into force) and to the SDS (inappropriate

language or SDS not matching the notification). Although some DNAs and the Agency

reported problems in complying with the timeframes of the notification procedure, the

number of notifications processed late remained low.

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4.2.1 Export notifications processed during the reporting period

During the reporting period, DNAs accepted and forwarded to the Agency 15,771

notifications, and rejected 1,214 notifications

The number of export notifications processed varies significantly between Member

States (see Figure 4). Four Member States did not process any export notification during

the reporting period (Latvia, Lithuania, Luxembourg and Slovakia) and five Member

States processed fewer than 10 notifications. The highest numbers of export

notifications during the reporting period were in Germany (5,196 notifications), France

(3,358), the UK (1,829), Italy (1,321) and Spain (1,265). The importing countries that

received the highest numbers of export notifications from the EU were Switzerland

(1,044 notifications), Turkey (984), Russia (890), the USA (754) and China (601).

Figure 4: Total number of export notifications accepted and forwarded to the Agency by DNAs

during the reporting period

10000

Notifications forwrded to ECHA

1000

100

Member States

The number of export notifications accepted and forwarded to the Agency by DNAs

increased significantly during the reporting period, from 1,553 in 2014, to 5,866 in

2015, to 8,352 in 2016

(see Table 11).

This section and those that follow are based on data extracted from ePIC by the Agency and provided to the

Commission, the DNAs and the consultant.

Figures provided by DNAs include rejected/re-submitted

notifications, in addition to ‘validated’ notifications

(i.e. accepted and processed).

For 2014 the period covered is 1 March

–

31 December (as the PIC Regulation became applicable on 1

March 2014).

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The Agency also reported an increase in the number of export notifications accepted and

processed during the reporting period, from 4,575 in 2014, to 5,460 in 2015, to 7,967 in

2016

, thus beyond the 10% increase originally envisaged (see Table 11). The number

of companies involved in PIC activities has also increased substantially, from 390 in

2014 to 1,177 in 2016

. The Agency concluded from this increase that awareness and

compliance with the Regulation has significantly improved during the reporting period.

The main factor that contributes to this increase is the inclusion of new chemicals in

Annex I. Table 11Error!

Reference source not found.

summarises the activities

carried out by the Agency in relation to export notifications during the reporting period.

Table 11: Export notifications and related tasks handled by the Agency during the reporting period

Export

notifications

handled

(including

initial

submissions,

resubmissions and rejections)

Export notifications forwarded

Acknowledgments of receipt received

Export notifications forwarded a

second time

2014

1,550

2015

5,845

2016

8,335

460

190

270

4,642

3,077

1,565

7,229

4,575

2,654

An acknowledgement of receipt is requested by the Agency for all export notifications

sent (not just the first one after Annex I inclusion, as stated in Article 8(3)), as this is an

important means of ensuring that the information has been received, especially as

contact details in non-EU countries change frequently.

4.2.2 Special RIN requests processed during the reporting period

Exporters of chemicals exported for research or analysis purposes in quantities that do

not exceed 10kg from each exporter to each importing country per calendar year use

the Special RIN request procedure, in which the exporter requests a Special RIN from

the DNA. If the request is accepted, this activates a Special RIN that the exporter can

use on the customs declaration. The Special RIN request procedure is also used in cases

where the exporter is exempt from export notifications, such as emergency situations,

when a positive import response has been given by the importing party and when a

country has waived its right to be notified.

During the reporting period, 17 Member States accepted 7,072 Special RIN requests.

Eleven Member States did not have to deal with any such request in the past three

years (Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Luxembourg,

Malta, Romania, and Slovakia). Germany, the UK and Belgium were the Member States

that accepted the highest number of Special RIN requests (see Figure 5).

Figures provided

for the Agency only include ‘validated’ notifications (i.e. accepted and processed) and

exclude rejected/re-submitted notifications, which explains the discrepancy with the figures provided for

DNAs.

ECHA, Increase in notifications providing information on the export of hazardous chemicals, press release

ECHA/PR/17/15, 6 September 2017:

https://echa.europa.eu/-/increase-in-notifications-providing-

information-on-the-export-of-hazardous-chemicals

Data available from 1 March 2014 (all other data in this column were available after go-live of the PIC

submission system, i.e. 2 September 2014).

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Figure 5: Total number of Special RIN requests accepted by DNAs during the reporting period

10000

Special RIN requests forwarded to ECHA

1000

100

Member States

4.2.3 Requests

for

notifications

resubmission

and

rejection

export

Member States requested the resubmission of 2,904 export notifications during the

reporting period. Figure 6 shows the significant variations between Member States.

Figure 6: Total number of resubmissions of export notifications requested by DNAs

in the

reporting period

France

Germany

Spain

United Kingdom

Italy

Belgium

Austria

Denmark

Finland

Netherlands

Poland

Portugal

Hungary

Bulgaria

Ireland

1173

525

327

287

242

200

400

600

800

1000

1200

1400

Total number of resubmissions requested by DNAs

Only Member States that requested the resubmission of more than 10 notifications are represented on the

graph.

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DNAs explained that resubmission of notifications were necessary where information

requirements were not met. Several DNAs further specified the missing or incorrect

information typically triggering the request for resubmission:



Information requirements not met in section 6 of the export notification form

–

summary of, and reasons for, the FRA and date of entry into force (five DNAs).



Information requirements not met in section 1 of the export notification form

–

identity of the chemical subject to the export notification: CAS number,

concentrations, name of product (one DNA).



Information requirements not met in section 3 of the export notification form

–

information concerning the export, e.g. phone number, importer address (one

DNA). One DNA also reported that in some cases exporters incorrectly ticked the

emergency situation box in order to avoid the 35-day waiting period.



Information requirements not met in section 4 of the export notification form

–

information on hazards and/or risks of the chemical and precautionary measures,

e.g. wrong classification (one DNA).

Several Member States also highlighted problems with the SDS attached to export

notifications:



The SDS was not submitted in the correct language (five DNAs).



The SDS did not match the export notification (four DNAs). Two DNAs specifically

mentioned inconsistencies in the composition of mixtures. Italy also pointed to

cases where the type of product (substance / mixture) was different on the SDS

and notification form.



Two DNAs mentioned errors on the SDS, in particular relating to codes.

The Agency requested the resubmission of 609 export notifications during the reporting

period (43 in 2014

, 334 in 2015, and 232 in 2016). The main reasons for requesting

resubmission of a notification were:



Issues with the data provided in Section 6.1 ‘Summary of and reasons for the

final regulatory action and date of entry into force’ (incorrect text/language).



Problems with the SDS: incorrect SDS attached to the notification; SDS

unavailable because attached in the incorrect place in ePIC; SDS language

incorrect.



Discrepancy between the data on the substance/mixture composition on ePIC

and on the SDS.

Member States rejected 1,214 export notifications during the reporting period. Figure 7

shows the numbers of rejected notifications for those Member States in which rejections

occurred most frequently.

Data only available after go-live of the PIC submission system (2 September 2014)

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Figure 7: Total number of export notifications rejected by DNAs during the reporting period

United Kingdom

Spain

France

Germany

Belgium

Italy

Netherlands

100

200

300

400

500

600

205

692

700

800

Total number of notifications rejected by DNAs

12 Member States stated that export notifications were rejected because they were not

applicable for the following reasons:



Duplication of notifications (10 DNAs).



The resubmission occurred too late (one DNA).



The emergency situation was not justified (one DNA).



Conditions for granting a special RIN were met (two DNAs).



Rejection requested by exporting company (two DNAs).



PIC chemical missing in mixture (one DNA).

Other Member States indicated

notification:



Information requirements

DNAs).



Wrong identification, e.g.

DNA).



Missing SDS in appropriate

that rejection was based on flaws in the export

not met or incorrect information provided (three

substance notified as mixture and vice versa (one

language (two DNAs).

Finally, one DNA pointed to cases where a notification was rejected because of the

negative consent received from the importing country.

The Agency rejected 175 notifications during the reporting period (51 in 2015 and 124 in

2016). In 2015, a large number of export notifications for didecyldimethylammonium

chloride were rejected because the substance was notified in a mixture at a

concentration level which did not trigger labelling of the mixture, irrespective of the

presence of any other substance (in accordance with Article 8(1)). In 2016, 124

notifications were rejected because the importing country had waived the requirement

to receive export notifications for exports of certain chemicals from the EU, or because

the mixture was not classified as hazardous, based on the information provided in the

SDS.

4.2.4 Difficulties encountered in the export notification procedure

Difficulties encountered by exporters in completing the export notification form

According to the Agency and DNAs, exporters have experienced difficulties in providing

information on the export (e.g. contact details of importers) and the intended use of the

chemical in the importing country (see Figure 8).

Only Member States that rejected more than 10 notifications are represented on the graph.

kom (2018) 0697 - Ingen titel

Figure 8: Question 19. What are the information requirements requested in the export notification

form where exporters have difficulties in providing the information?

Availability of CN codes or CUS codes

I for atio

o er i g the e port (e.g. o ta t details…

Intended use of the chemical in the importing country

I for atio o the fi al regulator a tio take

the…

None

ar of a d reaso s for fi al regulator a tio a d…

Additional information provided by the exporting Party

Identity of the mixture to be exported

I for atio o hazards or risks of the he i al a d…

Identity of the substance to be exported

ar of ph si o- he i al, to i ologi al a d…

Identity of the article to be exported

Number of Member States

In addition, the Agency indicated that the identity of the substance to be exported and

the summary of, and reasons for, the FRA and date of entry into force had also proved

problematic for exporters. Twelve DNAs also stated that the availability of Combined

Nomenclature (CN) or Customs Union and Statistics (CUS) codes were a particular

problem for exporters.

In addition to these issues, several DNAs highlighted other problem areas:



Two DNAs mentioned that providing the SDS in the correct language was an

issue for some exporters.



One DNA stated that the grouping of chemicals was a particular problem, and

that biocides were sometimes considered industrial chemicals and other times

pesticides.



One DNA indicated problems with the identification of research or analysis use

and applications for Special RIN requests.



One DNA mentioned problems with the identification of mixtures falling within the

scope of the Regulation.

The Agency also noted the following problems or mistakes:



If their chemical is not in ePIC, companies are not sure whether or not its export

is subject to the PIC Regulation (this issue relates specifically to group entries,

e.g. cadmium and its compounds, for which the list of cadmium compounds in

ePIC is not comprehensive).



Some exporters confuse export notifications for substances and mixtures.



Section 3.1 of the export notification (foreseen category and foreseen use in

importing country) is often confused with section 6.2 (category for which the FRA

was taken).



The intended use and use category for exports of biocides can be problematic

due to the fact that the EU considers ‘biocides’ to be a sub-category

of the

pesticides category, whereas many non-EU countries consider biocides industrial

chemicals.

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

Some companies insert controversial, non-factual messages in section 6.1 on the

FRA (e.g. they disagree with the fact that the substance was banned or severely

restricted in the EU) that are not acceptable, and the Agency has to ask for such

statements to be removed.

Not all companies provide the SDS (or equivalent information) in the official

language of the importing country or in an appropriate language.

The definition of an exporter (Article 3(18)) was not always easily applicable to

certain cases in which, for example, the holder of the contract was in a non-EU

country (Switzerland) but the export was physically shipped from the EU.

The obligation to notify the export of an article is set out in Article 15, in

conjunction with Article 3(4). It was often unclear to exporters, DNAs and the

Agency whether or not a given article is subject to the PIC Regulation.

Complying with timeframes

According to the Agency, some DNAs experienced difficulties in coping with the

timeframe to forward the export notifications. However, the number of export

notifications it received less than 25 days before the export remains relatively low

compared to the total number of notifications processed (725, or 4.9% of the total

number of notifications).

Seven Member States stated that they experienced such difficulties during the reporting

period. In particular, four Member States indicated that they have difficulties in

complying with the timeframes during the ‘peak season’ in winter. Two Member States

mentioned that companies did not respect deadlines for resubmission, thereby delaying

the whole procedure. The Agency explained that where the exporter had submitted the

export notification on time and the delay was in fact due to late processing by the DNA,

they processed the late export notification in order not to further penalise the exporter

and to allow the export process to continue. The Agency added that the authority in the

importing country is always alerted by a separate communication where an export

notification was delivered less than 15 days before the expected date of export (as

foreseen by Article 8(2) of the PIC Regulation).

The Agency indicated that it, too, experienced difficulties in coping with the timeframe to

process and forward export notifications to the importing country. However, the number

of late notifications remains very low. 171 notifications were sent late to the importing

countries, around 1.2% of the total number of export notifications forwarded to

importing countries during the reporting period. This is mostly due to delays in receiving

the notifications from the DNAs. In 30 cases, however, the delay was caused by the

Agency itself, mainly because of IT issues. According to the Agency, the authority in the

importing country is always informed accordingly.

4.2.5 Emergency situations (Article 8(5))

According to Article 8(5), when the export relates to an emergency situation in which

any delay may endanger public health or the environment in the importing country, the

DNA, in consultation with the Commission, may exempt the exporter from the

notification requirements or the waiting period. According to the Agency and the DNAs,

only a small number of export notifications referred to an emergency situation, most of

which did not meet Article 8(5) criteria and were rejected. Only two DNAs (Belgium and

Greece) stated that they had to deal with an emergency situation during the reporting

period. In Belgium, the export notification was rejected as it did not meet Article 8(5)

criteria. In Greece, the emergency situation concerned 1,3-dichloropropene imported by

Turkey, requesting a 120-day authorisation to use the chemical as a soil fumigant.

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4.2.6 Provision of available additional information on exported

chemicals

According to Article 8(7), the Commission, DNAs, the Agency and exporters should

provide additional information on the exported chemicals, at the request of the

importing party. The Agency received many requests to provide additional information

or clarifications on exported chemicals to importing parties and other countries. These

typically related to additional information on the importing company, clarification on the

intended use of the chemical in the importing country or on the quantities exported,

clarification on the reasons for notifying the export of the chemical or for requesting the

explicit consent for chemicals which are not listed in Annex III to the Rotterdam

Convention, and cases where the export notification was sent to the wrong authority.

Eight DNAs received similar requests. Information requested by the importing countries

related primarily to importer contact details. Other requested information related to the

chemical itself, e.g. name of the chemical, or information on the reasons for its ban or

restriction in the EU.

4.2.7 Administrative fee for export notifications

Member States are allowed to establish administrative fees for exporters for each export

notification and for each request for explicit consent made, corresponding to the cost

they incur in carrying out the procedures. Eight Member States request an

administrative fee for export notifications, and these fees vary greatly between Member

States (from EUR 25 to EUR 250). Three Member States request a fee for requests for

explicit consent. Member States received no complaints from exporters, nor did they

note any significant impact of the fee on the number of export notifications.

4.3 Export notifications from Parties and other countries (Article 9)

As per Article 9, the Agency must make available on its database the export notifications

it receives from third countries, acknowledge receipt of the notification to the DNA of the

exporting country and provide a copy to the DNA of the Member State(s) receiving the

import. The Agency was asked to provide information on the export notifications

received and acknowledgements sent.

The Agency received 1,105 export notifications from non-EU countries in the reporting

period (see Table 12). The number of notifications almost doubled between 2014 and

2016.

Table 12: Export notifications received from non-EU countries and acknowledgements sent during

the reporting period

Export notifications received

Acknowledgements sent

2014

209

2015

486

122

2016

410

Total

1,105

217

The difference between the number of notifications received and the number of

acknowledgements sent is due to the fact that the Agency does not send

acknowledgements of receipt to the US, based on a bilateral agreement between the

two parties, while the US is the country sending the greatest number of notifications to

the EU.

Data only available after go-live of the PIC submission system (2 September 2014).

kom (2018) 0697 - Ingen titel

4.4 Information on export and import of chemicals (Article 10)

Article 10 places obligations on exporters and importers to inform the DNA of the

quantity of chemicals listed in Annex I of the PIC Regulation exported to or imported

from third countries during the preceding year. This must be done during the first

quarter of each year. Exporters must also provide the DNA with the names and

addresses of each importer. DNAs must, in turn, provide this information to the Agency

annually, which then aggregates the data at EU level and makes it publicly available on

its database.

DNAs and the Agency were asked (in their respective questionnaires) about any delays

and difficulties encountered in fulfilling their obligations under Article 10. Their

responses suggest that the reporting under Article 10 works well.

Delays in collecting information

Ten DNAs stated that several exporters had delayed the submission of information on

the quantity of the chemicals exported, but said that exporters generally submitted the

information after a reminder. Eight DNAs stated that they had experienced delays from

importers in submitting their information. These delays did not affect the completion of

the reporting exercise under Article 10, as the Agency did not encounter similar delays

from DNAs in receiving the aggregated national reports on the quantity of exported and

imported chemicals.

Reporting through ePIC

Very few DNAs reported problems with reporting through ePIC, with only two indicating

that they had experienced difficulties in their Article 10 reporting. Two DNAs indicated

that they experienced delays in submitting aggregated information through ePIC.

Aggregating information at EU level

According to the Agency, the aggregation of information was complicated by incorrect

reporting by some DNAs, which had included data on exports of PIC chemicals exported

for research and analysis purposes (below 10kg per year and per importing country).

These exports are out of the scope of Article 10 and should not be reported by DNAs.

Use of Article 10 data

Data gathered for the purposes of Article 10 reporting are used by the DNAs, customs or

other enforcement authorities in 16 Member States. Eight DNAs indicated that the data

are used for enforcement activities, with six specifying that it is used for REACH

enforcement activities (e.g. cross-checking compliance with registration requirements,

or checking compliance with restrictions).

4.5 Notification of banned or severely restricted chemicals under the

Convention (Article 11-12)

As per Article 11 of the PIC Regulation, the Commission must notify the Secretariat of

the Rotterdam Convention, in writing, of the chemicals listed in Part 2 of Annex I, which

qualify for PIC notification. The Commission, assisted by the Agency, drafted the

notifications and submitted these to the DNAs for comments before submitting them to

the Secretariat. Three notifications were submitted to the Secretariat during the

reporting period (see Table 13).

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Table 13: PIC notifications sent to the Secretariat during the reporting period

Basis for notification

Commission Regulation (EC) No 73/2013

(2014)

Commission Delegated Regulation (EU)

No 1078/2014

Chemicals notified after inclusion in Annex

Commission Delegated Regulation (EU)

No 2015/2229

Chemicals notified

Naled

Bitertanol

Fenbutatin oxide

Date of notification

2014

October 2016

4.6 Obligations in relation to importing chemicals (Article 13)

As per Article 10 of the Convention, Parties are requested to adopt an import decision

for each new chemical listed in Annex III and to submit it to the Secretariat within nine

months of receipt of the notification of the listing and the decision guidance document.

Pursuant to Article 13 of the PIC Regulation, the import decision is adopted by means of

an implementing act. The Commission drafts the implementing act containing relevant

import decisions, which is then submitted to the REACH Committee for an opinion, in

accordance with the advisory procedure.

During the reporting period, the Commission adopted two Implementing Decisions (see

Table 14). In 2014, the Commission drafted import decisions for azinphos-methyl,

commercial

pentabromodiphenyl

ether,

commercial

octabromodiphenyl

ether,

perfluorooctane sulfonic acid, perfluorooctane sulfonates, perfluorooctane sulfonamides

and perfluorooctane sulfonyls, which were submitted to the REACH Committee on 7

April, with the Commission Implementing Decision adopted on 15 May 2014. In 2015,

the Commission drafted a new import decision for methamidophos and revised the

import decisions on DDT and ethylene oxide, which were submitted to the REACH

Committee in late 2015. The Implementing Decision was adopted on 11 February 2016.

Table 14: EU import responses adopted during the reporting period

Implementing

Act

Commission

Implementing

Decision of 15

May 2014

Chemicals

Azinphos-methyl

Commercial

pentabromodiph

enyl ether

Nature / status of

decision

New

Final

decision

New

Final

decision

Import

decision

No consent

to import

Consent to

import only

subject to

specified

conditions

Consent to

import only

subject to

specified

conditions

No consent

to import

Commercial

octabromodiphe

nyl ether

New

decision

Final

Perfluorooctane

sulfonic

acid,

perfluorooctane

sulfonates,

perfluorooctane

sulfonamides

and

perfluoro-

octane sulfonyls

New

decision

Final

Grounds for

decision

Banned for use

under PPPR

Banned for use,

subject to

specific

exemptions

under POPs

Regulation

Banned for use,

subject to

specific

exemptions

under POPs

Regulation

Banned for use,

subject to

specific

exemptions

under POPs

Regulation

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Implementing

Act

Commission

Implementing

Decision of 11

February

2016

Chemicals

Methamidophos

Ethylene oxide

Nature / status of

decision

New

Final

decision

Amending

Interim

decision

DDT

Amending

decision

Final

Import

decision

No consent

to import

Consent to

import only

subject to

specified

conditions

No consent

to import

Grounds for

decision

Banned for use

under PPPR

Banned for use

under PPPR and

restricted under

BPR

Banned for use

under POPs

Regulation

Article 13(5) requires the DNAs to make EU import decisions available to those

concerned within their competence. DNAs fulfil this requirement by email and by

publishing those decisions on their website.

4.7 Obligations in relation to exports of chemicals, other than export

notifications (Article 14)

Article 14 requires the explicit consent of the importing country before an export of

chemicals listed in Parts 2 or 3 of Annex I can proceed, unless a positive import

response is available in the latest PIC Circular for chemicals listed in Part 3 of Annex I.

DNAs and the Agency were asked to provide data on explicit consent procedures carried

out during the reporting period, as well as any difficulties they encountered in doing so.

Nineteen Member States implemented the explicit consent procedure during the last

three years, highlighting some importing countries’

difficulties in handling requests sent

by Member States as the main challenge. Fewer Member States dealt with Article 14(6)

and (7) provisions, and the information provided by DNAs suggests that few

implementation problems occurred. Although, according to the Agency, it was initially

challenging to interpret the cases to which Article 14(8) provisions applied, the number

of problem cases has nonetheless been reduced to a very low level.

4.7.1 Communication of information and decisions to those

concerned within the jurisdiction of a Member State (Article

14(3))

Article 14(1) requires the Commission to forward PIC circulars and other relevant

information received from the Secretariat of the Convention to Member States, the

Agency, and industry associations. The Member States then communicate this

information to those concerned in their jurisdiction. All DNAs fulfil this requirement,

mainly through emails and the provision of information on their website (Article 14(3)).

4.7.2 Explicit consent (Article 14(6))

During the reporting period, 19 Member States sought explicit consent from the DNA of

the importing country, under Article 14(6)(a). A total of 3,362 requests for explicit

consent were handled by DNAs (see Figure 9).

This section and those that follow are based on data extracted from ePIC by the Agency and provided to the

Commission, the DNAs and the consultant.

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Figure 9: Number of requests for explicit consent received by DNAs during the reporting period

10000

Requests for explicit consent

1000

DE; 1286

FR; 559

BE; 283

NL; 204

IT; 142

PL; 47

AT; 27

CZ; 21

FI; 20

HU; 20

IE; 10

HR; 4

CY; 3

DK; 3

PT; 2

SI; 4

SE; 113

ES; 376

UK; 238

100

Member States

Of the 3,362 requests for explicit consent, 56% were answered. The share decreased

over the reporting period (61% in 2014, 58% in 2015, and 51% in 2016). This

explained why the Agency had to send a significant number of reminders. A first

reminder was sent for 65% of the requests, and a second reminder for 42% of the

requests (see Table 15).

Table 15: Reminders for explicit consent requests sent by the Agency during the reporting period

2014

2015

2016

Total

First reminder

469

826

899

2,194

Second reminder

235

627

563

1,425

During the reporting period, there were four instances in France and Germany where for

chemicals listed in Part 3 of Annex I, explicit consent from the DNA of the importing

country was provided by the latest circular issued by the Secretariat of the Rotterdam

Convention, according to Article 14(6)(b) (see Table 16).

Table 16: Number of requests for explicit consent pursuant to Article 14(6)(b)

Member State

France

Germany

2014

2015

2016

Total

For 2014, the period covered is 1 March-31 December (as the PIC Regulation became applicable on 1 March

2014).

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Difficulties

procedure

encountered

the

implementation

the

explicit

consent

Eight Member States reported having experienced difficulties in implementing the

explicit consent procedure. According to most DNAs, the main challenge was late

responses from importing countries to consent requests (i.e. after the 60-day waiting

period) or no response at all. The DNAs also stated that the response provided was not

always clear or was difficult to interpret, that certain countries were particularly difficult

to reach (e.g. where the request had to be sent by regular mail), and that certain

countries imposed additional national rules that caused further delays.

The Agency’s involvement in the explicit consent procedure consists of verifying the

metadata associated with explicit consent requests after it is uploaded to ePIC by the

DNA (and before it can be used for processing purposes). According to the Agency, this

process has worked smoothly in recent years and has contributed to harmonised data

and the reduction of clerical errors during the procedure.

The Agency also mentioned that it had agreed a procedure with the Commission and the

EU DNAs for the handling of requests for explicit consent received from a non-EU

country, as the PIC Regulation does not provide any such procedure. This procedure, it

stated, could be reflected in the legal text.

4.7.3 Waivers (Article 14(6) and (7))

Explicit consent in case of exports of chemicals listed in Part 2 of Annex I to

OECD countries

According to Article 14(6), when a chemical qualifying for PIC notification is exported to

an OECD country, the DNA can waive the requirement for explicit consent on a case-by-

case basis, at the request of the exporter and after consulting the Commission. Six

Member States were requested to decide whether or not explicit consent was required in

the case of export of chemicals listed in Part 2 of Annex I to OECD countries (see Table

17). None of the Member States experienced difficulties in taking such a decision.

Table 17: Number of cases where DNAs were required to decide whether or not explicit consent

was required in case of export of chemicals listed in Part 2 of Annex I to OECD countries

Member State

France

Germany

Italy

Netherlands

Sweden

United Kingdom

2014

2015

2016

Total

DNA decisions that export may proceed 60 days after an explicit consent

request was made

According to Article 14(7), the DNA of the exporting country can take the decision, on a

case-by-case basis and in consultation with the Commission, assisted by the Agency, to

waive the explicit consent requirement when no reply from the importing country has

been received after 60 days. Such waivers can only be granted if certain conditions are

met and for a maximum period of 12 months, after which time the exporter will need to

seek explicit consent again. Eleven Member States received waiver requests in

accordance with Article 14(7) during the reporting period (see Table 18).

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Table 18: Number of waiver requests received per Member State during the reporting period

Member State

Belgium

Finland

France

Germany

Hungary

Italy

Netherlands

Poland

Spain

Sweden

United Kingdom

2014

2015

2016

Total

Two Member States stated that they experienced difficulties in implementing the waiver

procedure. One DNA had difficulties with the languages in which the documents were

submitted and had to request translations, while the second found it difficult to identify

whether or not the documents provided were valid.

4.7.4 Validity of explicit consent (Article 14(8))

According to the procedure described in Article 14(6), explicit consent, once obtained, is

valid for three calendar years, after which it must be requested again, unless the terms

of the consent require otherwise. Export may continue for an additional 12 months after

the three-year period, however, pending a response to a new request for explicit

consent.

Fourteen Member States experienced cases where the export was allowed to proceed

pending a reply to a new request for explicit consent (see Table 19). The highest

number was reported by Germany, with 138 cases in total.

Table 19: Number of cases where the export was allowed to proceed pending a reply to a new

request for explicit consent, by Member State, during the reporting period

Member State

Austria

Belgium

Cyprus

Finland

France

Germany

Hungary

Italy

Netherlands

Poland

Slovenia

Spain

Sweden

United Kingdom

2014

2015

103

2016

Total

138

According to the Agency, Article 14(8) was initially difficult to implement due to

misunderstandings in its interpretation and a lack of understanding of the cases to which

it applied. The issue was then discussed at the 25

DNA meeting (on 21 April 2015) and

a common approach was identified. Once the way forward had been agreed, the related

functionality in ePIC was also modified in order to better support the implementation of

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this provision. Since then, although the provision remains challenging to implement, the

number of problem cases (i.e. in which the Agency and the DNAs disagree on the

interpretation) has been reduced to a very low level.

4.8 Information on transit movement (Article 16)

None of the Member States implemented Article 16 during the reporting period.

4.9 Requirements linked to exported chemicals and accompanying

information (Article 17)

Article 17 states that exported chemicals must be packaged and labelled in accordance

with the provisions on packaging and labelling in the CLP Regulation, the PPPR and the

BPR. The information on the label must also include the expiry date (for different climate

zones if necessary) and the production date. An SDS compliant with Annex II of the

REACH Regulation must be sent to each importer, together with the chemical. The

information on the label and the SDS should be given in the official languages, or in one

or more of the principal languages, of the country of destination or of the area of

intended use, insofar as possible.

The DNAs were asked to provide information on compliance issues observed during the

reporting period. Any such issues chiefly related to packaging requirements under the

CLP Regulation and the SDS.

Compliance issues relating to packaging and labelling requirements

The national enforcement authorities in eight Member States experienced compliance

issues concerning the information accompanying exported chemicals. Six Member States

indicated that they had identified compliance issues relating to the packaging

requirements of the CLP Regulation (see Figure 10).

Figure 10: Question 52. Were these compliance issues related to the application of packaging and

labelling requirements under PPPR, BPR, CLP or other regulations?

CLP

AT, CZ, FR, HU, IT, PT

Other

AT, BG, UK

BPR

AT, CZ, IT

PPPR

CZ, IT

Number of Member States

Compliance issues with the SDS and the language(s) of the label or SDS

Six Member States reported finding compliance issues relating to the application of SDS

requirements under the REACH Regulation.

Other compliance issues concerned the obligation to give information in one or more

official/principal languages of the country of destination, both on the label and on the

SDS (see Figure 11).

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Figure 11: Question 54. Were these compliance issues related to the obligation to give information:

on the label in one or more official/principal languages of the country of destination or on the SDS

in one or more official/principal languages of the country of destination?

On the label in one or more official/principal languages

of the country of destination

On the safety data sheets in one or more

official/principal languages of the country of destination

AT, CZ, FR, IT, PT, UK

AT, BG, FR, HU, PT

Number of Member States

Finally, two Member States reported experiencing compliance issues regarding the

information and packaging requirements linked to the exported products. Both indicated

that these compliance issues were related to the expiry date and the storage conditions

on the label.

4.10 Enforcement of Regulation (EU) No 649/2012 (Article 18)

According to Article 18 of the PIC Regulation, Member States must designate authorities

(such as customs authorities) to control the import and export of chemicals listed in

Annex I. The Commission, supported by the Agency, and the Member States must

coordinate their enforcement activities in respect of the PIC Regulation. The Forum for

Exchange of Information on Enforcement, established by the REACH Regulation, should

also be used to coordinate the network of authorities responsible for enforcement of the

PIC Regulation.

Article 18 states that Member States must provide information on the activities of their

enforcement authorities in their Article 22 reports. The questionnaire asked Member

States to report on: the organisation of enforcement activities at national level and their

enforcement strategy; training of inspectors; enforcement actions and their penalty

system; collaboration between National Enforcement Authorities (NEA) and DNAs and

Forum activities; and asked them to provide data on the enforcement activities and

infringements observed during the reporting period.

Information provided by the DNAs shows that all Member States have put in place a

system to ensure compliance with the PIC Regulation. All Member States have

nominated authorities responsible for the enforcement of the PIC Regulation (in most

Member States, this is the customs authority and the environmental/health

inspectorate). Many Member States have put in place some kind of enforcement

strategy (including rules of procedures, written instructions, etc.), and around half have

established regular training of inspectors. Most Member States have also described their

applicable penalty system. Twenty Member States reported having carried out controls

on exports or imports during the reporting period, 11 of which provided data on the

results of the controls, showing that few infringements were detected. Finally, DNA

feedback on the Forum activities was positive, with some welcoming the launch of a pilot

project dedicated to the PIC Regulation.

4.10.1 National enforcement authorities (NEAs)

Most Member States have several authorities in charge of enforcing the PIC Regulation.

Customs are involved in the implementation of the PIC Regulation in all Member States

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except Malta and the United Kingdom. In four countries, the customs administration is

the sole NEA (Spain, Croatia, Italy and Slovakia). Other enforcement authorities are

typically environmental, chemical and/or health inspection services. In nine Member

States, the NEA is part of the same institution as the DNA.

In almost all of the Member States in which NEAs are involved in the enforcement of the

PIC Regulation, they are also typically involved in the enforcement of the CLP Regulation

(27 Member States), the REACH Regulation (25 Member States), and the BPR (22

Member States).

The majority of Member States (18) indicated that NEAs have sufficient resources to

carry out their obligations under the PIC Regulation. Where Member States pointed to

insufficient resources in NEAs, they referred specifically to the lack of human resources.

4.10.2 Training inspectors

Fifteen Member States indicated that inspectors are regularly trained on the PIC

Regulation. Among the Member States that have organised regular training, eight stated

that such training is included as part of general training on chemicals legislation, while

four mentioned training specific to the PIC Regulation. Nine reported training specifically

targeting inspectors, while four mentioned training for customs officers.

Most Member States with no regular training on PIC explained that specific/regular

training was not needed during the reporting period, often because of training provided

by the Agency, national guidelines, and regular exchanges of information between the

DNAs and the NEAs. Only one Member State reported that training had not taken place

because of the lack of specialised trainers.

4.10.3 Enforcement strategy

Sixteen Member States reported having a strategy for the enforcement of the PIC

Regulation, of which 14 have already implemented that strategy (see Figure 12).

Figure 12: Question 62. Does your authority (or any other relevant authority) have an enforcement

strategy for Regulation (EU) No 649/2012?

HR, DK, EE, FI,

FR, EL, LV, LU,

MT, SI, ES, SE

AT, BE, BG, CY,

CZ, DE, HU, IE,

IT, LT, NL, PL,

PT, RO, SK, UK

Yes

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4.10.4 Enforcement activities

During the reporting period, 18 Member States carried out conformity checks and 15

carried out on-site visits in which the PIC Regulation was covered (see Figure 13).

Figure 13: Enforcement activities carried out in Member States

Conformity checks

AT, BE, BG, HR, CY, CZ, EE, FI, FR, DE, HU, IE, LT, NL, PL, PT, RO, SK

On-site visits

AT, BE, BG,CZ, EE, DE, HU, IE, LT, NL, PL, PT, RO, SI, SE

Others

DK, DE, EL, IT, LT, MT, NL, UK

Sampling

AT, EE, DE, IE, IT

No enforcement activities carried out

LV, LU, ES

Number of Member States

Eight Member States mentioned other enforcement activities (see Table 20):



Reactive operations/investigation of issues brought to the DNA’s attention;



Controls carried out as part of integral controls on compliance with REACH/CLP;



Cooperation with customs;



Risk-oriented random checks during custom clearance;



Conformity checks to assess whether or not a substance falls within the scope of

the PIC Regulation;



Document checks;



Checking reports submitted to the national database.

In 13 Member States, customs performed controls related to the PIC Regulation during

the reporting period, representing the largest number of controls in most countries.

NEAs performed controls on exports in 11 Member States. DNAs reported the following

data:

Table 20: Total number of official controls on exports in which the PIC Regulation was covered or

enforced during the reporting period, by Member State

Member State

Austria

Belgium

Customs

561

N/A

Inspectors

Others

N/A

Luxembourg and Latvia ticked ‘other’, indicating that no enforcement activities were carried out (as no

exports took place during the reporting period).

Available data from the inspectors cover only parts of the inspection activities, as export control is not

separated from general controls; consistent statistics on export-related enforcement activities of NEAs will

be available from 2017 onwards (implementation of a new Reporting scheme).

Information missing (N/A) as the cooperation agreement between the DNA and the customs is not yet in

force.

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Member State

Bulgaria

Croatia

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Romania

Slovakia

Slovenia

Spain

Sweden

United Kingdom

Customs

463

N/A

3633

123

N/A

401

275

N/A

135

N/A

Inspectors

N/A

661

Others

N/A

In four Member States, customs carried out controls on imports during the reporting

period. NEAs reported performing controls on imports in nine Member States. DNAs

reported the data contained in Table 21.

Table 21: Total number of official controls on imports in which the PIC Regulation was covered or

enforced during the reporting period, by Member State

Member State

Austria

Belgium

Bulgaria

Croatia

Cyprus

Czech Republic

Denmark

Estonia

Finland

Customs

N/A

Inspectors

N/A

For Year 1, figures from the customs authority cover the whole year 2014

–

including the period before the

entry into force of the new PIC Regulation.

No statistics or records are kept by the customs authorities in Germany.

The category ‘other’ includes conformity checks to assess whether a substance falls within the scope of PIC

regulation or not.

Member States

could report other types of controls in the column ‘other’, although none did.

The DNA indicated that data for customs were not available.

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Member State

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Romania

Slovakia

Slovenia

Spain

Sweden

United Kingdom

Customs

N/A

804

N/A

248

N/A

Inspectors

N/A

661

4.10.5 Enforcement actions and penalty systems

Member States were asked to describe the measures that enforcement authorities can

take to ensure compliance with the PIC Regulation, and their penalty system in case of

infringement. DNAs typically described a mix of enforcement measures, such as seizure

and detention of goods, withdrawal from the market, suspension of activities etc. Ten

Member States stated that NEAs could issue letters of formal notice to request

compliance within a certain timeframe. On penalties for infringements, 23 Member

States indicated that they impose fines for specific infringements, often with a scale of

fines depending of the gravity of the infringement. In seven Member States, a penalty of

imprisonment can be imposed on the most serious infringements.

4.10.6 Infringements during the reporting period

Infringements found through customs controls

Three Member States reported identifying infringements through customs controls

(Germany, France and Italy) (see Table 22). The number of infringements is very low

compared to the number of customs controls performed

. Germany indicated that the

infringement found by customs concerned a chemical that did not conform to the export

notification.

Table 22: Number of customs controls and infringements observed during the reporting period

Member State

France

Germany

Italy

Controls on exports

123

401

Controls on imports

N/A

804

Infringements found

Germany reported one infringement for one control but specified that records of customs controls were not

kept.

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Infringements found through inspectors’ controls

Nine Member States found infringements through controls carried out by inspectors

(Table 23). As there might be overlaps between the numbers of controls performed on

exports and imports, it was deemed better not to calculate shares of infringements.

However, it should be noted that the number of infringements compared to the number

of controls varies greatly across the nine Member States. One reason for this variation

might be that different types of controls were performed. For example, the UK DNA

explained that reactive controls were performed, which might explain the low number of

controls and the high probability of detection of an infringement.

Table 23: Numbers of controls carried out by inspectors and infringements observed during the

reporting period

Member State

Austria

Belgium

Bulgaria

Finland

Germany

Hungary

Lithuania

Netherlands

United Kingdom

Controls on exports

661

Controls on imports

N/A

661

Infringements found

The main category of infringement found through inspections was non-conformity of the

chemical with the export notification. Infringements relating to SDS and labelling

requirements were also found (see Table 24).

Table 24: Types of infringements of the PIC Regulation observed by inspectors during the reporting

period

Member State

Labelling

requirements

Safety data

sheets

Expiry date

the

chemical

Chemical not in

conformity

with

export notification

Other

Austria

Belgium

Bulgaria

Finland

Germany

Hungary

Lithuania

Netherlands

United Kingdom

N/A

The four infringements reported as ‘other’ concerned: omitting to report imports

(Finland); missing the reporting obligations under Article 10 (Hungary) and exporting

without export notification (Lithuania).

Of the infringements reported in ‘other’, none

were through the controls reported in the

category ‘other’ (i.e. made by neither customs nor inspectors).

Lithuania reported that one exporter was identified as exporting without notification and controlled. Although

one control is reported for exports and one for imports, it is the same control.

As the Netherlands reported the exact same number of controls by inspectors for exports and imports in 2014,

2015, and 2016, it can be assumed that both exports and imports were checked during the same controls.

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Penalties

Thirteen infringements led to penalties in four Member States. In Lithuania, the

Netherlands and Austria, all infringements led to penalties, while only a small

percentage of infringements (10%) resulted in a penalty in Germany (see Table 25).

Table 25: Number of infringements that led to penalties during the reporting period

Member State

Austria

Germany

Lithuania

Netherlands

Number of infringements

4.10.7 Collaboration between DNAs and NEAs

Collaboration between DNAs and NEAs

Twenty-three Member States reported regular exchanges of information between the

DNA(s) and enforcement authorities. Six Member States stated that, as the DNA and the

NEA are in the same institution, the exchange of information occurs on a daily basis, as

necessary. Six other Member States indicated that regular meetings were held between

DNAs and NEAs to exchange information, while a further eight mentioned regular

exchange of information by email through contact points, or following procedures

provided for in laws, agreements or guidelines, or through annual inspection reports

sent to the DNA.

Few Member States described the types of information exchanged: cases of exports and

imports and exporting/importing companies (four Member States), interpretation and

scope of the PIC Regulation (two Member States), updates and changes in the PIC

Regulation (one Member State).

Eleven Member States made suggestions to improve collaboration between the DNAs

and enforcement authorities. Some also mentioned the following exchanges of

information between authorities at national level:



Enhance information exchange / updates between the DNA and enforcement

authorities, including customs;



Organise face-to-face meeting at least once a month;



Organise training courses on PIC issues for all enforcement authorities;



Keep information available on DNA and NEA websites up to date with legal

changes.

Other comments related to actions to be taken at EU level:



Exchange of best practices between Member States with a lot of experience in

PIC controls and those with quite limited numbers of exports subject to PIC

Regulation provisions;



Make the PIC procedure more visible in the Forum;



Improve cooperation and coordination by DG ENV with DG TAXUD;



Fully implement the Single Window System, to control all customs declarations

that have indicated a RIN code, not only the customs declaration physically or

controlled by documentation;



Ensure specific CN codes are used, as these are easier to control than products

with generic CN codes.

Collaboration between DNAs and national members of the Forum for Exchange

of Information on Enforcement

Twenty-three Member States reported regular exchange of information between the

DNAs and the national member(s) of the Forum.

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Of those Member States reporting close collaboration, seven explained that regular

exchanges of information occur without formal communication or coordination

mechanisms, as the Forum member is also a member of the DNA or is part of the same

institution . Other Member States indicated regular exchange of information, either

through written/electronic communication channels or through regular meetings

between institutions on outcomes of DNA and Forum meetings and activities of the

Forum related to PIC (e.g. pilot projects, guidance development).

Nearly all Member States (26) indicated their satisfaction with the collaboration with the

national Forum members.

Five Member States provided suggestions for improving collaboration between DNAs and

Forum members:



Inform DNAs about any Forum activities concerning the PIC Regulation, provide

DNAs with direct access to Forum documents, or give DNAs the option to

participate in Forum meetings;



The Forum Secretariat at the Agency, which also reports to the DNA meetings,

should inform Forum members in advance, so that they can contact their DNA(s)

about issues in enforcement;



Invite Forum members involved in PIC activities to attend PIC DNA meetings;



Increase communication between DNAs and Forum members.

One DNA added that the planned PIC pilot enforcement project presents a good

opportunity to enhance collaboration between DNAs, Forum members, NEAs and

customs.

4.10.8 Forum activities

The Forum did not engage in any regular exchange of information on the PIC Regulation

during the reporting period, but such exchange is part of the Forum’s Multiannual Work

Programme. In 2016, the Forum decided to run a pilot project on PIC enforcement,

focusing on export notifications. The preparation and execution of this project will take

place in the next reporting period. The Forum has also defined the specifications for the

PIC form in the ICSMS tool (Commission-owned IT platform for exchange of information

in a secure way between NEAs).

Although Forum activities on PIC are just beginning, 19 Member States indicated their

satisfaction with the activities carried out by the Forum.

Eight Member States suggested improvements to the activities of the Forum in respect

of the PIC Regulation:



Five Member States pointed to the need to carry out enforcement projects or

pilot projects related to the PIC Regulation;



One Member State suggested adding the PIC Regulation to the general controls

on REACH, CLP, POPs, mercury;



One Member State underlined the importance of keeping the PIC best practice

document up-to-date;



One DNA suggested increasing the possibilities for sharing experiences between

Member States;



One Member State suggested that DNA experts should be invited to Forum

meetings for discussions on activities relating to PIC Regulation.

According to the Agency, careful prioritisation of PIC activities is essential, given the

limited resources of the Forum, and the many priority areas for coordinated

One Member State provided the same justification for replying ‘no’.

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enforcement. One potential improvement would be to increase the number of PIC-

related activities, including integration into enforcement projects relating to other

legislation.

4.11 Exchange of information (Article 20)

According to Article 20, the Commission, assisted by the Agency, and the Member

States must facilitate the provision of scientific, technical, economic and legal

information to other countries on chemicals subject to the PIC Regulation, including

toxicological, ecotoxicological and safety information. Every two years, the Agency must

compile all of the relevant information that has been transmitted.

Information provided following ad-hoc requests

The Commission provided an answer to two requests from third countries in 2014-

2015



One from Peru, asking whether or not three particular mixtures were subject to

an export notification under the EU PIC Regulation.



One from Serbia, requesting clarifications of the provisions on mercury with

respect to Regulation (EU) No 649/2012 and Regulation (EC) No 1102/2008.

The Commission replied to four requests in 2016 from four countries (Canada,

Indonesia, Lebanon and Syrian Arab Republic) concerning four chemicals. In addition,

information was sent to Ecuador in response to a request.

The Agency did not receive any requests within the scope of Article 20 in either 2014 or

2015. It received two requests in 2016, from the authorities in the Syrian Arab Republic

and China, respectively.

EU Member States did not receive any ad-hoc requests for information during the

reporting period.

Reporting on the information transmitted

The Agency published its first compilation of transmitted information in November

2016

, covering the first two years of implementation of the PIC Regulation (2014-

2015). The report addresses information submitted by means of export notifications,

FRA notifications, and following ad-hoc requests. The next Article 20 report will cover

the 2016-2017 period.

The Agency did not experience difficulties in collecting the information from the

Commission and the Member States on the data transmitted. The only challenge it

reported was in clarifying the scope of the report with the Commission and Member

States, as it was the first of its kind. The scope of the report was clarified between the

Commission and the Agency and discussed with the DNAs at the 27th DNA Meeting (held

on 26 April 2016). The Agency shared the lessons learned from this reporting exercise at

the 28

DNA meeting (14 December 2016) in order to achieve more clarity for the next

reporting period.

ECHA,

Overview on the exchange of information under Article 20 of the PIC Regulation - Compilation of the

information collected by the European Commission, assisted by the Member States and the European

Chemicals Agency (ECHA),

2016, available at:

https://echa.europa.eu/documents/10162/21728206/pic_article_20_report_2014-2015_en.pdf/ad0e2b0d-

4f12-486f-b1da-9fd2ddbbb187

Idem.

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4.12 Technical assistance (Article 21)

Under Article 21, the Commission, DNAs and the Agency must cooperate in promoting

technical assistance, in particular to help developing countries and countries with

economies in transition to implement the Convention and to develop the infrastructure,

capacity and expertise necessary to manage chemicals properly throughout their

lifecycles. In addition, the Commission and DNAs must actively participate in

international activities in capacity-building in chemicals management, and consider

giving support to NGOs.

The Agency and DNAs were asked to describe the activities in which they participated.

The Agency mainly participated in activities intended to explain the specific provisions of

the PIC Regulation and the differences with the provisions of the Convention. DNA

activities, by contrast, consisted of the provision of technical expertise or technical

information through training workshops, visits, twinning projects, etc.

Cooperation with developing countries, countries with economies in transition

and NGOs

During the reporting period, the Agency was involved in the following cooperation

activities:



2015 workshop organised by the Rotterdam Convention Secretariat to strengthen

cooperation on the implementation of the Convention between the DNAs of

Burundi, Cameroon, Congo, Djibouti, Gabon and Rwanda. The aim was to clarify

the provisions of the Rotterdam Convention and highlight the differences with the

EU PIC Regulation.



2016 workshop organised by the Rotterdam Convention Secretariat to strengthen

cooperation on the implementation of the Convention between the DNAs of

Benin, Burkina Faso, Cabo Verde, Ivory Coast, Gambia, Guinea, Guinea

–

Bissau,

Mali, Mauritania, Niger, Senegal, Chad and Togo. Although the Agency cancelled

its participation, it had already contributed to preparing the training materials,

presentations, etc.

Five Member States participated in cooperation activities, mostly relating to the

provision of technical information and technical expertise in the preparation of FRA

notifications to the Secretariat (see Figure 14).

Figure 14: Question 56. What types of cooperation have you been involved in?

Technical information

Technical expertise for the preparation of

notifications to the Secretariat

Promotion of the exchange of experts

Other

Technical expertise for the identification of

hazardous pesticides formulations

Support for the establishment or maintenance of

DNAs

BE, BG, DE, SE

BE, BG, SI

BG, SI, SE

AT, DE

Number of Member States

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Three DNAs mentioned other types of cooperation:



Participation in sub-regional workshops organised by the Secretariat of the

Convention (Yaoundé, 16-19 November 2015 and Dakar, 28 November-1

December 2016), mentioned above by the Agency (Belgium);



Expert assistance in setting up the international dimension of the Georgian

Ministry of Environment’s Waste and Chemicals Management Department

and

Legal Department, in particular on the development of national legislation and

training staff on the implementation and enforcement of the Rotterdam

Convention and the EU PIC Regulation within a twinning project on Waste

Management in Georgia GE/10/ENP-PCA/EN06, 2012-2014 (Bulgaria);



Visits of an expert delegation to the Member States’ institutions (visit of the

Federal Institute for Operational Safety and Health in Dortmund) (Germany).

Capacity-building activities

The Agency organised or participated in capacity-building activities on the sound

management of chemicals. These targeted EU candidate countries and potential

candidates for EU accession, with a view to supporting them at a technical level to align

with the REACH, CLP, BRP and PIC Regulations. These activities took place under the EU

Instrument for Pre-accession assistance (IPA), the European Neighbourhood and

Partnership Instrument (ENPI), the Technical Assistance and Information Exchange

instrument (TAIEX) and twinning projects. PIC-related issues were also put on the

agenda of third country visits to

the Agency’s premises.

The Agency provided some examples of capacity-building activities:



2014 workshop on PIC and ePIC for EU candidate countries and potential

candidates;



3-day visit of a delegation from Turkey to

the Agency’s premises, to

provide an

overview of the Rotterdam Convention and the EU PIC Regulation;



Participation in PIC and ePIC training organised by a technical assistance project

for Turkey;



Bilateral discussions with 47 non-EU countries at the margins of the 7th

Conference of the Parties to the Rotterdam Convention to clarify the specific

provisions of the PIC Regulation, discuss problem cases and gather feedback

from the authorities in the non-EU countries.

Six Member States participated in projects or international activities relating to capacity-

building in chemicals management during the reporting period:



Twinning project on Waste Management in Georgia (Bulgaria, see above);



Activities related to the Minamata Convention and SAICM (France);



Visit of the Federal Institute for Operational Safety and Health in Dortmund

(Germany, see above);



A TAIEX project in Turkey (Italy);



Twinning Project (2015–2017) on the Further Development of Chemicals and

Biocides Products Management in the Republic of Serbia (Slovenia);



International training courses financed by the Swedish International Development

Cooperation Agency, regional meetings and working sessions focussing on

capacity-building and other aspects of the sound management of chemicals in

Southeast Asian countries, Southern African Development Community countries,

Brazil, Indonesia, China and Serbia (Sweden).

4.13 IT-related aspects

Under Regulation (EU) No 649/2012, the Agency developed and continues to maintain

the IT tool ePIC to support the implementation of the PIC Regulation, in particular the

exchange of information between industry users, i.e. exporters, and authorities. ePIC

was launched in September 2014, shortly after the entry into force of Regulation (EU)

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No 649/2012 and replaced the previous EDEXIM database. It consists of three

interfaces, one for industry users, one for authority users (DNAs, the Commission, the

Agency and enforcement authorities) and one for customs officers.

For the purposes of this reporting exercise, the Agency was asked to provide information

on the operation and use of ePIC and the data made publicly available on its website.

Member States were asked to provide information on the use of ePIC data at national

level and their experiences in using ePIC.

Overall, the DNAs assessed ePIC as user-friendly and reported no major issues in using

it. Feedback from industry users to the Agency and DNAs was also generally positive, as

was the feedback from customs and enforcement authorities received by DNAs. The

Agency identified some improvement needs for ePIC that will be implemented in the

next reporting period, some of which are based on user feedback. All of the data that

should have been made publicly available by the Agency according to the Regulation,

were indeed made available online during the reporting period.

4.13.1 The ePIC system

During the reporting period, a total of 2,352 authority and industry users used ePIC (see

Table 26).

Table 26: Number of ePIC users during the reporting period

Industry

DNAs

Commission

NEAs

Number of users

1,836

127

388

As there is no user management for the customs application, the Agency could only

provide estimates for the use of the customs interface:



26 Member States consulted the application;



One Member State checked over 2,500 individual notifications;



One Member State checked approximately 600 individual notifications;



Five Member States checked between 100-350 individual notifications;



Seven Member States checked between 40-100 individual notifications;



12 Member States checked fewer than 20 individual notifications.

The following new features were added to the ePIC system during the reporting period:



Management of Article 10 report through ePIC: submission of Article 10 report by

exporters and importers; checking of reports by DNAs; aggregation of national

reports by DNAs and submission to the Agency; compilation of Member State

data by the Agency.



Enhanced explicit consent metadata, with the new ‘RIN match algorithm’

functionality.



Waiver management.



Bulk special RIN submissions available to industry.



Automated sending of all email communication for export notifications, including

cover notes, second sending of export notifications after 30 days (in the absence

of an acknowledgement of receipt) and explicit consent reminders.



Pre-filled explicit consent request forms for DNAs.



Possibility for the Agency users to add/edit PIC chemicals.

Regarding DNA and NEA accounts: the numbers provided in the table refer to the existing number of

accounts created and tokens issued for ePIC. They do not necessarily

refer to ‘active users’ of ePIC.

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

Implementation of fully-fledged workflows with associated task items and

deadlines.

Event history, submission history and message history available, allowing

traceability for audit purposes and for everyday follow-up of tasks/actions.

Message box embedded in task items.

Enhanced security of the application.

According to the Agency, these new features reduced processing time, increased

efficiency, enabled traceability and contributed to ensuring consistency and reliability of

the data in the system. They also enabled all stakeholders (industry, DNAs, the

Commission and the Agency itself) to manage an increasing number of tasks and meet

legal deadlines without significantly increasing their staff numbers.

4.13.2 User-friendliness of the ePIC system

DNAs

According to the Agency, the feedback received from the DNAs was generally positive.

Many of their suggestions for improvement were implemented during the reporting

period.

In their reporting questionnaires, the DNAs were also generally positive about the user-

friendliness of ePIC in carrying out their main obligations under the PIC Regulation. The

only area where several Member States reported difficulties was the Article 10 reporting

(see Figure 15).

Figure 15: Question 79. Is the ePIC system easy to use for DNAs?

When dealing with export notifications (Article 8)

When dealing with requests for explicit consent

(Article 14)

When dealing with special RIN requests (Article

19(2))

When dealing with waivers (Article 14 (6) and (7))

When dealing with reporting pursuant to Article 10

When dealing with other PIC procedures

Number of Member States

Yes

No experience

Exporters and importers

Similarly, the Agency received generally positive feedback from industry users, with

stakeholder surveys indicating that 87% of industry users in 2015 and 96.7% in 2016

were satisfied with ePIC. The simplicity of the application and the pre-filled data were

reported as being particularly valuable.

The feedback received by DNAs from industry users was also generally positive,

although it should be noted that only around half of the Member States replied to this

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question (see Figure 16). Levels of satisfaction with ePIC are slightly lower for export

notifications and Article 10 reporting.

Figure 16: Question 80. Where possible, please provide feedback from exporters on the user-

friendliness of the ePIC system.

General user-friendliness

Export notifications

Special RIN requests

Waivers

Article 10 Reporting

Management of mixtures/articles via ePIC

Number of Member States

Easy to use

Not easy to use

No Answer

One DNA mentioned that companies judged the ePIC User Manual too lengthy and

detailed, and suggested that it would be useful to create user-friendly factsheets, or

short guidance, such as those that exist for REACH. Another DNA recommended that

guidance and tools should be provided in national languages.

One DNA stated that exporters would find the export notification process more user-

friendly if they could communicate directly with the Agency to understand, for instance,

why a notification is rejected or pending resubmission. It pointed out that the exporter

does not receive the importing country’s answer in cases where it does not give explicit

consent or rejects the export notification, creating problems for companies who do not

know why consent has not been given, or how they might amend their notification or

assist their clients in the importing country with their approach to their own authorities.

The same DNA also mentioned that exporters would find it helpful to have the Active

RIN Period in the overview.

On Article 10 reporting, one DNA stated that exporters would find it easier to submit a

single report containing all of the information rather than having to enter different

information (amount, country, etc.) separately.

For enforcement authorities

19 Member States reported that their customs authorities used ePIC, the majority of

whom (12) stated their belief that customs found ePIC easy to use and adequate to

support their work.

As national enforcement authorities other than customs have only had access to ePIC

since the second quarter of 2016, the Agency has not yet received any relevant

feedback. Six Member States, however, indicated that their enforcement authorities

used ePIC and considered it easy to use and adequate to support their work.

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4.13.3 Areas of improvement

The Agency identified the following improvement needs for ePIC with a view to reducing

processing times, reducing the occurrence of clerical errors, increasing compliance with

legal obligations, and providing for a better user experience overall:



Include the generation of non-confidential Article 10 reports in ePIC;



Improve the RIN match algorithms;



Improve the management of the chemicals database to make the chemicals

easier to search and edit, simplify the insertion of new amendments, make the

breakdown of group entries more transparent to companies, and facilitate data

dissemination;



Improve usability for exporters by improving data validation checks,

standardising alerts and error messages, improving the document upload

functionality and related options;



Further refine search options to facilitate navigation through the increased

volume of data in the system;



Improve internal messaging to ensure that as much communication as possible

can happen within the system, for traceability and audit purposes;



Enhance the Agency’s back-office

functionality to reduce the number of manual

tasks or tasks which require database changes.

4.13.4 Data dissemination

According to the PIC Regulation, the Agency should make the following data publicly

available:



The list of chemicals included in Annex I (Article 7);



The updated list of chemicals subject to export notification, and the importing

Parties and other countries for each calendar year (Article 8);



Reports on actual quantities of chemicals subject to the PIC Regulation exported

and imported (Article 10);



Import decisions (Article 13);



Non-confidential data on explicit consents received from non-EU countries (Article

14).

The Agency has a specific webpage dedicated to the PIC Regulation, where the content

of the legislation and the different procedures are explained. The webpage also contains:



A link to the legal text and its amendments

;



Article 10 reports on actual quantities of chemicals exported and imported

;



Article 20 reports on information exchange, published for the first time in

November 2016

According to the Agency, the approach to Article 10 reporting, in particular the

calculation and presentation of data, has been significantly revised compared to previous

years. The new approach enables the disclosure of more data while respecting the

Eurostat recommendations on data confidentiality. The data are presented in two levels

of aggregation, one focused on the exported chemical(s) and the other on the countries

of export and destination.

As required by the PIC Regulation, the Agency has also set up a database containing:

PIC legislation:

https://echa.europa.eu/regulations/prior-informed-consent/legislation

Annual reporting on PIC exports and imports:

https://echa.europa.eu/regulations/prior-informed-

consent/annual-reporting-on-pic-exports-and-imports

Reporting on information exchange:

https://echa.europa.eu/regulations/prior-informed-consent-

regulation/reporting-on-information-exchange

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

The list of chemicals subject to the PIC Regulation

;

High-level information and statistics on export notifications

;

High-level information and statistics on import notifications

;

Non-confidential data on explicit consents received from non-EU countries

;

EU and non-EU DNA contact details

In addition, information on substances subject to the PIC Regulation is also made

available through the Agency’’s

webpages ‘Information on chemicals’, which provide an

infocard for each substance, and, for others, a more detailed profile.

Feedback received by the Agency on the publicly available data from authorities in non-

EU countries was positive. In particular, those authorities found it useful to have

summaries of export notifications and explicit consents for their countries. Feedback

from companies and trade associations was more mixed. A small number of companies,

together with one of the main industry trade associations, highlighted that the chemicals

subject to the PIC Regulation (especially the breakdown of group entries) is not always

clear on the website and could be improved. The Agency has noted this request for

improvement and will consider it at a later stage.

Chemicals subject to PIC:

https://echa.europa.eu/information-on-chemicals/pic/chemicals

Export notifications:

https://echa.europa.eu/information-on-chemicals/pic/export-notifications

Import notifications: https://echa.europa.eu/information-on-chemicals/pic/import-notifications

Explicit consents: https://echa.europa.eu/information-on-chemicals/pic/explicit-consents

DNAs:

https://echa.europa.eu/information-on-chemicals/pic/designated-national-authority

kom (2018) 0697 - Ingen titel

Annex

Report of the European

Commission on the

Operation of the PIC

Regulation (EU) No 649/2012

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Contents

INTRODUCTION ................................................................................................... 59

INTERNAL WORK OF THE COMMISSION .................................................................. 60

2.1.

Internal organisation and resources .............................................................. 60

2.1.1.

2.1.2.

2.1.3.

2.1.4.

2.2.

2.2.1.

2.2.2.

2.2.3.

2.2.4.

2.3.

2.3.1.

2.3.2.

Resources ..................................................................................... 60

The Agency’s

budget

...................................................................... 60

Coordination between the Commission and the Agency....................... 61

Coordination between the Commission and DNAs ............................... 61

Amendments of Annexes I and V to the PIC Regulation ...................... 61

Union import decisions ................................................................... 63

Guidance to Member States on the legal interpretation of the PIC

Regulation .................................................................................... 64

Adoption of a format for reporting on the implementation of PIC ......... 65

Emergency situations (Article 8(5)) and waivers (Article 14(7)) ........... 66

Enforcement of the PIC Regulation ................................................... 66

Policy work ................................................................................................ 61

Implementation and enforcement of the PIC Regulation .................................. 66

INTERNATIONAL WORK OF THE COMMISSION ......................................................... 66

3.1.

3.2.

3.3.

3.4.

Preparation, coordination and submission of EU input to the Secretariat, the

COP, the CRC and other subsidiary bodies ..................................................... 67

Communication of information to the Secretariat of the Rotterdam Convention... 68

Financial contribution to the Rotterdam Convention ........................................ 68

Exchange of information (Article 20) ............................................................. 69

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Abbreviations used

BPR

CAS

CoP

DDT

DNA

ECHA

PIC

POPs

PPPR

REACH

Biocidal Products Regulation

Chemical Abstracts Service

Conference of the Parties to the Rotterdam Convention

Dichlorodiphenyltrichloroethane

Designated National Authority

European Chemicals Agency

Prior Informed Consent

Persistent Organic Pollutants

Plant Protection Products Regulation

Registration, Evaluation, Authorisation and Restriction

Regulation

Chemicals

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1. Introduction

Article 22 of Regulation (EU) No 649/201243

(‘PIC Regulation’) requires

the Commission

to report on its activities under the Regulation every three years and to compile a

synthesis report on the performance of the PIC Regulation, integrating:



The information submitted by Member States as per Article 22(1) concerning the

operation of the procedures provided for in this Regulation, including customs

controls, infringements, penalties and remedial actions.



The information submitted by the European Chemicals Agency (ECHA) as per

Article 22(1) concerning the operation of the PIC

Regulation’s procedures.

This reporting exercise is the first under the new PIC Regulation. It covers the three

years of implementation since the Regulation entered into force in 2014 (2014-2016). A

common reporting format for Designated National Authorities (DNAs) was established by

Commission Implementing Decision (EU) 2016/770 of 14 April 2016

, in order to collect

consistent information across Member States. A reporting format for the Agency’s report

was adopted through Commission Implementing Decision (EU) 2016/1115 of 7 July

2016

The present report is the Commission report on the performance of the functions for

which it is responsible under the PIC Regulation, for the period 2014-2016. As per

Article 22(2), it is incorporated in the synthesis report on the operation of the

procedures during the period 2014-2016 provided for in Regulation (EU) No 649/2012,

together with the information submitted by the Member States and the Agency.

In drafting this report, relevant information was compiled from EUR-lex, the website of

the Rotterdam Convention, and documents published on CIRCABC, including minutes of

meetings, and other documents discussed at DNA meetings. The sources used for this

report are listed in Table 1.

This report is divided into two sections, the

Commission, and the second addressing the

the EU DNA, coordinator of input provided

representative of the EU under the Rotterdam

Table 1 : List of relevant documents consulted

first addressing the internal work of the

international work of the Commission, as

by the EU and its Member States, and

Convention.

List of relevant documents consulted

Implementing and delegated acts



Commission Delegated Regulation (EU) No 1078/2014 amending Annex I to the PIC

Regulation.



Commission Delegated Regulation (EU) 2015/2229 amending Annex I to the PIC

Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the

export and import of hazardous chemicals, OJ L 201, 27.7.2012, pp. 60–106.

Commission Implementing Decision (EU) 2016/770 of 14 April 2016 establishing a common format for the

submission of information concerning the operation of the procedures pursuant to Regulation (EU) No

649/2012 of the European Parliament and of the Council concerning the export and import of hazardous

chemicals, C/2016/2068, OJ L 127, 18.5.2016, pp. 32–51.

Commission Implementing Decision (EU) 2016/1115 of 7 July 2016 establishing a format for the submission

by the European Chemicals Agency of information concerning the operation of the procedures pursuant to

Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and

import of hazardous chemicals, C/2016/4141, OJ L 186, 9.7.2016, pp. 13–23.

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List of relevant documents consulted

Regulation.



Commission Implementing Decision of 11 February 2016 adopting Union import decisions

(2016/C 61/06).

Commission Implementing Decision of 15 May 2014 adopting Union import decisions

(2014/C 152/02).

Commission Implementing Decision of 14 April 2016 establishing a common format for the

submission of information concerning the operation of the procedures pursuant to

Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning

the export and import of hazardous chemicals.

Commission Implementing Decision of 7 July 2016 establishing a format for the

submission by the European Chemicals Agency of information concerning the operation of

the procedures pursuant to Regulation (EU) No 649/2012 of the European Parliament and

of the Council concerning the export and import of hazardous chemicals.



DNA meeting documents



Minutes of 23

, 24

, 25

, 26

, 27

and 28

DNA meetings.



Amendments to Annex I to Regulation (EU) No 649/2012, presented at 23

, 24

, 25

, 27

and 28

DNA meetings.



Import decisions presented at 23

, 24

, and 26

DNA meetings.



Submission of notifications to the PIC Secretariat, presented at 23

, 24

, 25

, 26

, 27

and 28

DNA meetings.

Implementation issues presented at 23

, 24

, 25

, 26

, 27

and 28

DNA meetings.

Documents on the preparation of COP 7 and 8, presented at 25

, 26

and 28

DNA

meetings.

Rotterdam Convention’s documents



PIC circulars published by the Rotterdam Convention.

2. Internal work of the Commission

2.1. Internal organisation and resources

2.1.1. Resources

DG Environment is in charge of the PIC Regulation. Unit B.2

–

sustainable chemicals has

one policy coordinator responsible for carrying out the Commission’s administrative

functions under PIC. The policy coordinator is supported by a lawyer for legal questions

and by a secretary for all organisational work. For international work, Unit B.2 has one

expert (the policy coordinator) nominated to the Convention bodies, i.e. the CRC and

the intersessional working group on the process of listing chemicals in Annex III to the

Convention. In addition, colleagues of Unit F.3, responsible for multilateral

environmental cooperation, contribute to the international work, in particular in the

context of the Conference of the Parties (CoP), by dealing with horizontal and cross-

cutting matters, such as financial resources, budget, technical assistance and some legal

matters. The staff resources occupied by this work amount to 0.4 FTE for the policy

coordinator and 0.4 FTE for the supporting work, including international matters.

2.1.2.

The Agency’s budget

According to Article 24, the budget of the Agency for the operation of the PIC Regulation

consists of a subsidy granted by the EU for the purposes of this Regulation. The subsidy

for the period 2014-2016 was set by the Commission as part of its Multiannual Financial

Framework 2014-2020.

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2.1.3. Coordination between the Commission and the Agency

The Commission and the Agency cooperate closely in the implementation of Regulation

(EU) No 649/2012. There are regular exchanges on scientific, technical and legal

questions arising in the context of implementation, in particular the legal interpretation

of provisions and their practical implementation. The Agency participates in all PIC DNA

meetings and reports on the work done in the area of implementation, including the

operation of the IT application (ePIC) and the work of the Forum on the Exchange of

Information on Enforcement. The Commission contributed to the development of the

guidance produced by the Agency and also to the work of the Forum on Exchange of

Information on Enforcement.

For cooperation with third countries and the Secretariat of the Rotterdam Convention,

the Commission and the Agency closely coordinate their activities to ensure that the

most appropriate and effective assistance is provided, and that resources are used

efficiently.

2.1.4. Coordination between the Commission and DNAs

The Commission and the DNAs of the Member States closely cooperate in the

implementation of Regulation (EU) No 649/2012. There are regular exchanges on

scientific, technical and legal questions arising in the context of implementation, in

particular through discussions at the twice-yearly PIC DNA meetings. If necessary, and

where appropriate, the Commission consults DNAs in writing on specific questions. At

the same time, individual DNAs consult the Commission on specific questions of

interpretation and implementation of the Regulation.

The Commission coordinates and consults with DNAs on any submissions to the

Secretariat of the Rotterdam Convention. On cooperation with third countries, the

Commission and DNAs coordinate some of their activities to ensure coherence of the

assistance provided and efficient use of resources.

2.2. Policy work

2.2.1. Amendments of Annexes I and V to the PIC Regulation

Annexes to the PIC Regulation are amended through delegated acts, adopted by the

Commission, in accordance with Articles 23 and 26 of Regulation (EU) No 649/2012. The

procedure for adoption of delegated acts requires the Commission to consult experts on

draft amendments. As the Commission explained in the 23

and subsequent DNA

meetings, this consultation is carried out by presenting the drafts at the DNA meetings

in order to ensure that all Member State experts, as well as observers, have the

opportunity to comment. Delegated acts are also scrutinised by the European Parliament

and the Council to ensure that the Commission does not exceed its powers.

Amendments to Annex I

Proposed amendments to Parts 1 and 2 of Annex I are triggered by regulatory actions

changing the legal status of a substance under other relevant EU legislation, in

particular:



Decision not to approve or to withdraw an active substance under the PPPR.



Decision not to approve or to withdraw an active substance under the BPR.



Decision to subject a chemical to authorisation by adding it to the Authorisation

List (Annex XIV) of the REACH Regulation.



Decision to restrict the use of a chemical (Annex XVII) under the REACH

Regulation.

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During the reporting period, two Delegated Regulations amending Annex I were

adopted, in 2014 and 2015 (see Table 2). Of the substances added to Annex I, many

were proposed for inclusion in Parts 1 and 2 of Annex I to the PIC Regulation because

they had been banned for use as plant protection products under Regulation (EC) No

1107/2009, which represented a ban or severe

restriction in the use category ‘pesticide’.

This was the case for bitertanol, cyhexatin, azocyclotin, cinidon-ethyl, cyclanilide,

ethoxysulfuron, oxadiargyl, didecyldimethylammonium chloride, and warfarin in 2014,

and fenbutatin oxide in 2015. In addition, substances severely restricted as pesticides,

such as rotenone and cyfluthrin in 2014, were added to Annex I.

Table 2 : Substances added to Annex 1 during the reporting period

Delegated Act

Commission

Delegated

Regulation

(EU)

No 1078/2014 of

7 August 2014

amending Annex I

to Regulation (EU)

No 649/2012

Chemical

Azocyclotin

Bitertanol

Cinidon-ethyl

Cyclanilide

Cyfluthrin

Cyhexatin

Ethoxysulfuron

Didecyldimethylammonium

Chloride

Oxadiargyl

Rotenone

Warfarin

Azinphos-methyl

Perfluorooctane sulfonic acid

Perfluorooctane sulfonates

Perfluorooctane sulfonamides

Perfluorooctane sulfonyls

1,1-Dichloroethene

1,1,2-Trichloroethane

1,1,1,2-Tetrachloroethane

1,1,2,2-Tetrachloroethane

Dibutyltin compounds

Dioctyltin compounds

Fenbutatin oxide

Lead compounds

Pentachloroethane

Trichlorobenzene

Commercial

pentabromodiphenyl ether,

including: tetrabromodiphenyl

ether, and pentabromodiphenyl

ether

Commercial octabromodiphenyl

ether, including

hexabromodiphenyl ether and

heptabromodiphenyl ether

Amendment

of Annex I

Part 1 and 2

Part 1and 2

Part 1 and 2

Part 1

Part

1 and 2

Basis for

inclusion

PPPR

Annex III

REACH

PPPR

REACH

Annex III

Commission

Delegated

Regulation

(EU)

2015/2229 of 29

September 2015

amending Annex I

to Regulation (EU)

No 649/2012

to RC

Part 3

Annex III to RC

Lead compounds, dibutyltin compounds, dioctyltin compounds, trichlorobenzene,

pentachloroethane,

1,1,2,2-tetrachloroethane,

1,1,1,2-tetrachloroethane,

1,1,2-

trichloroethane and 1,1-dichloroethene were added to Annex I in 2015, as they were

severely restricted as industrial chemicals for public use under the REACH Regulation.

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Amendments to Part 3 of Annex I reflect the decisions of the CoP to include certain

chemicals in Annex III to the Convention, bringing them under the PIC procedure.

Azinphos-methyl,

perfluorooctane

sulfonic

acid,

perfluorooctane

sulfonates,

perfluorooctane

sulfonamides

and

perfluorooctane

sulfonyls,

commercial

pentabromodiphenyl ether including tetra- and pentabromodiphenyl ether, as well as

commercial octabromodiphenyl ether including hexa- and heptabromodiphfaenyl ether,

were included in Part 3 of Annex I during the reporting period, following their inclusion

in Annex III to the Rotterdam Convention.

The inclusion of other substances in Annex I was under discussion in 2016, but has not

yet been formally adopted through a Delegated Regulation. These substances are listed

in Table 3.

Table 3 : Chemicals proposed for inclusion in Annex I

Chemical

Tepraloxydim

Carbendazim

Triflumuron

Triclosan

cybutryne

2,4-dinitrotoluene

4,4’-

diaminodiphenylmethane

(MDA)

5-tert-butyl-2,4,6-trinitro-

m-xylene

benzyl butyl phthalate

Diisobutyl phthalate

Diarsenic pentaoxide and

tris(2-chloroethyl)

phosphate

Methamidophos

Amendment of Annex I

Part 1 and 2

Part 1

Part 1 and 2

Basis for inclusion

PPPR

BPR

REACH

Part 1 and 2

REACH

Part 1 and 3

Annex

III

Convention

Rotterdam

Amendments to Annex V

At the 27

meeting of the DNAs in April 2016, an amendment to Annex V was

discussed, notably the inclusion of hexabromocyclododecane to Part 1 of Annex V to the

PIC Regulation. Hexabromocyclododecane was included in Part A of Annex I to

Regulation (EC) No 850/2004 (POPs Regulation), following the decision taken under the

Stockholm Convention to list this chemical in Part 1 of Annex A to the Stockholm

Convention, and should thus be listed in Annex V to the PIC Regulation.

2.2.2. Union import decisions

As per Article 10 of the Convention, Parties are required to adopt an import decision for

each new chemical listed in Annex III and to submit it to the Secretariat within nine

months of receipt of the notification of the listing and the decision guidance document.

Pursuant to Article 13 of the PIC Regulation, the import decision is adopted by means of

an implementing act, following the advisory procedure. The Commission drafts the

import decision, which is then submitted to the REACH Committee for an opinion, in

accordance with the advisory procedure.

During the reporting period, the Commission adopted two Implementing Decisions (see

Table 4). In 2014, the Commission drafted import decisions for azinphos-methyl,

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commercial

pentabromodiphenyl

ether,

commercial

octabromodiphenyl

ether,

perfluorooctane sulfonic acid, perfluorooctane sulfonates, perfluorooctane sulfonamides

and perfluorooctane sulfonyls, which were submitted to the REACH Committee on 7 April

and the Commission Implementing Decision was adopted on 15 May. In 2015, the

Commission drafted a new import decision for methamidophos and revised the import

decisions on DDT and ethylene oxide, which were submitted to the REACH Committee in

late 2015. The Implementing Decision was then adopted on 11 February 2016.

Table 4 : Union import responses adopted during the reporting period

Implementing

Act

Commission

Implementing

Decision of 15

May 2014

Chemicals

Azinphos-methyl

Commercial

pentabromodiphe

nyl ether

Nature / status of

decision

New

Final

decision

New

Final

decision

Import

decision

No consent

to import

Consent to

import only

subject to

specified

conditions

Consent to

import only

subject to

specified

conditions

No consent

to import

Commercial

octabromodiphen

yl ether

New

decision

Final

Commission

Implementing

Decision of 11

February

2016

Perfluorooctane

sulfonic

acid,

perfluorooctane

sulfonates,

perfluorooctane

sulfonamides and

perfluorooctane

sulfonyls

Methamidophos

Ethylene oxide

New

decision

Final

Grounds for

decision

Banned for use

under PPPR

Banned for use,

subject to

specific

exemptions

under POPs

Regulation

Banned for use,

subject to

specific

exemptions

under POPs

Regulation

Banned for use,

subject to

specific

exemptions

under POPs

Regulation

New

decision

Amending

decision

Final

Interim

DDT

Amending

decision

Final

No consent

to import

Consent to

import only

subject to

specified

conditions

No consent

to import

Banned for use

under PPPR

Banned for use

under PPPR and

restricted under

BPR

Banned for use

under POPs

Regulation

2.2.3. Guidance to Member States on the legal interpretation of the

PIC Regulation

During the reporting period, the Commission, together with the Agency, clarified a

number of implementation issues concerning the PIC Regulation, either based on

implementation experience or requests from Member States. These were discussed in

DNA meetings under implementation issues (see Table 5).

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Table 5 : Implementation issues discussed at DNA meetings

DNA meeting

DNA meeting (April 2014)

DNA meeting (December 2014)

DNA meeting (April 2015)

DNA meeting (December 2015)

DNA meeting (April 2016)

DNA meeting (December 2016)

Implementation issues discussed

Period for application of the waiver for export

to OECD countries

Exports of mercury containing measuring

devices

Revision of explicit consent form to adapt it to

the new PIC terminology

Explicit

consents

for

nonylphenol

and

nonylphenol ethoxylates

Interpretation and implementation of replies to

requests for explicit consent

Interpretation of acknowledgement of receipt

of an export notification as an explicit consent

Use category applied in importing countries

Interpretation of the second paragraph of

Article 14(8)

Management of requests for explicit consent by

India

Waiver on certain chemicals exported to Brazil

Explicit consent requests received from Serbia

Interpretation of consent covering only the

CAS number of paraquat

Interpretation and implementation of replies to

requests for explicit consent

Classification of DDAC when exported

EU position on language of submitted SDS

Content of section 6.1 of export notifications

In 2015, the Commission also provided guidance on the implementation of the

Regulation by drafting a PIC customs factsheet providing information on the PIC

Regulation to customs. Member States were asked to distribute the factsheet to the

relevant authorities.

2.2.4. Adoption of a format for reporting on the implementation of

PIC

Every three years, Member States and the Agency are required to submit information on

the operation of the PIC Regulation’s procedures (Article 22(1)). According to Article 22,

the Commission was to adopt a common format for reporting through an implementing

act. Two implementing acts, one laying down the common format for reporting for

Member States (Decision 2016/770) and the other for the Agency (Decision 2016/1115)

were adopted, in April and July 2016, respectively, after a long consultation process with

Member States and the Agency (see Table 6).

Table 6 : Implementing acts adopted during the reporting period

Decision

Commission

Implementing

Decision

(EU)

2016/770

Commission

Implementing

Decision

(EU)

2016/1115

Title

Common format for the submission of information

concerning the operation of the procedures pursuant

to Regulation (EU) No 649/2012

Format for the submission by the European

Chemicals Agency of information concerning the

operation of the procedures pursuant to Regulation

(EU) No 649/2012

Date

April 2016

July 2016

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2.3. Implementation and enforcement of the PIC Regulation

2.3.1. Emergency situations (Article 8(5)) and waivers (Article

14(7))

According to Article 8(5), when the export of a chemical relates to an emergency

situation in which any delay may endanger public health or the environment in the

importing Party or another country, the DNA can waive in whole or in part the

obligations of the notification procedure (waiting period and/or notification

requirements). The DNA’s decision must be taken in consultation with the Commission,

assisted by the Agency. Few export notifications referred to an emergency situation

during the reporting period.

According to Article 14(7), a DNA can decide that an export of chemicals listed in Part 2

or 3 of Annex I can proceed if no response to a request for explicit consent has been

received within 60 days, or if no evidence from official sources of final regulatory action

(FRA) to ban or severely restrict the use of the chemical has been taken by the

importing Party or another country. The DNA must consult the Commission in making

this decision.

In both cases, the procedures worked smoothly during the reporting period, and the

Commission was positive about its coordination with the DNAs.

2.3.2. Enforcement of the PIC Regulation

The Commission cooperates with the Forum for Exchange of Information on Enforcement

with respect to enforcing the PIC Regulation. During the reporting period, the Forum

gave a mandate to the Working Group Electronic Information Exchange System (EIES)

to analyse the requirements for a system for exchange of information on PIC

enforcement. The Working Group recommended using ICSMS, the Commission-owned IT

platform for exchange of information between National Enforcement Authorities (NEAs),

once it has been adapted to the needs of PIC enforcement authorities. The Commission

informed the Member States at the 28

DNA meeting in December 2016 that these

changes would be implemented into ICSMS in the first half of 2017.

In 2015, the Commission also drafted a PIC customs factsheet, providing customs

authorities in the Member States with appropriate information on the PIC Regulation, in

particular the obligations of relevant stakeholders and their enforcement.

3. International work of the Commission

The international work of the Commission covers its participation in Rotterdam

Convention activities and all exchanges with the Secretariat of the Convention. The

Commission acts as the common designated authority of the EU for the administrative

functions of the Convention with reference to the PIC procedure (Article 5(2)). As the EU

DNA, the Commission is responsible for:



Representation of the EU to the Rotterdam Convention.



Coordination of EU input on all technical issues related to the Convention, the

preparation of the CoP, the Chemical Review Committee (CRC), and other

subsidiary bodies of the CoP.



Submission to the Secretariat of relevant FRA notifications concerning chemicals

qualifying for PIC notification.



Transmission of information concerning other FRA involving chemicals not

qualifying for PIC notification.



Submission to the Secretariat of Union import responses for chemicals subject to

the PIC procedure.



Exchange of information with the Secretariat in general.

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3.1. Preparation, coordination and submission of EU input to the

Secretariat, the COP, the CRC and other subsidiary bodies

Representation of the Union to the Rotterdam Convention and coordination of

EU input



7th Conference of the Parties to the Rotterdam Convention

During the reporting period, the Commission represented the EU at the 7

Conference of

the Parties to the Rotterdam Convention, which took place from 4-15 May 2015, back-

to-back with the 12

CoP to the Basel Convention and the 7

CoP to the Stockholm

Convention.

Before CoP 7, the Commission prepared and consulted with the Member States (as it did

for previous CoPs) on the position of the EU on matters discussed at the meeting, which

consisted of:



A proposal for a Council Decision establishing the EU position on amendments to

Annex III to the Convention, to get the mandate for decision-making at the CoP.

This document was then discussed at the Council Working Party on International

Environmental Issues and at the Council Working Party on Environment, and

adopted by the Council on 6 March 2015.



A position paper, discussed with the Member States at the Council Working Party

on International Environmental Issues’ meetings, presenting the position to be

taken on the various items that would be discussed at the CoP. The final version

of this position paper was agreed in April 2015.



A position paper on budget and management issues, covering the Rotterdam,

Basel and Stockholm Conventions, as the Programmes of Work and budgets of

the three Conventions were addressed in a joint session.



A position paper on technical assistance and financial issues, also covering the

Rotterdam, Basel and Stockholm Conventions.

All position papers were accompanied by a document outlining the statements to be

delivered on behalf of the EU or the EU and its Member States in plenary sessions of the

COP. Those documents were also drafted by the Commission, in consultation with the

Member States.

After CoP 7, the Commission presented the outcomes of the CoP to DNAs at the 26

DNA meeting on 21 October 2015. The Commission also submitted, together with the

Presidency, an information note on the outcomes of the CoP to the Rotterdam, Basel and

Stockholm Convention, transmitted by the General Secretariat of the Council to the

delegations on 10 June 2015. In addition, all of the statements made on behalf of the

EU or on behalf of the EU and its Member States during the CoP were published,

together with the statements made at the 12

CoP to the Basel Convention and the 7

CoP to the Stockholm Convention, through an information note of the General

Secretariat of the Council to delegations on 6 July 2015.



8th Conference of Parties to the Rotterdam Convention

During the reporting period, the Commission started preparing the proposal for a Council

Decision on the amendments of Annex III to the Convention and the position of the EU

and its Member States on matters that would be discussed at the next CoP, scheduled to

take place from 24 April- 5 May 2017.

Participation in committees and expert groups

Members of the Commission participated as experts in the various Convention bodies,

along with experts from Member States:



The CRC, where a Commission official was nominated by Spain and acted as

Chair of the three meetings of the CRC that occurred during the reporting period:

the 10

Meeting of the CRC in October 2014, the 11

meeting in October 2015

and the 12

meeting in September 2016.

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

The intersessional working group on the process of listing chemicals in Annex III

to the Convention, where one official represented the Commission.

The Commission on the CRC meetings and the work of the intersessional working group

of the Convention at the subsequent DNA meetings.

3.2. Communication of information to the Secretariat of the

Rotterdam Convention

Notification of FRA

As per Article 11 of the PIC Regulation, the Commission must notify the Secretariat of

the Rotterdam Convention, in writing, of the chemicals listed in Part 2 of Annex I which

qualify for PIC notification. The Commission drafts the notifications, which are submitted

to DNAs and observers for comments before being submitted to the Secretariat.

Three notifications were submitted to the Secretariat during the reporting period:



Chemicals notified after inclusion in Annex I by Commission Regulation

(EC) No 73/2013 (2014)

Naled



Chemicals notified after inclusion in Annex I by Commission Delegated

Regulation (EU) No 1078/2014 (October 2016)

Bitertanol



Chemicals notified after inclusion in Annex I by Commission Delegated

Regulation (EU) No 2015/2229 (October 2016)

Fenbutatin oxide

Communication of Union import responses

In line with Article 10 of the Rotterdam Convention and Article 13 of the PIC Regulation,

the Commission communicated the formally adopted import decisions to the Secretariat

of the Rotterdam Convention. The import decisions were published on the Convention

website in December 2014 and June 2017.

Ad-hoc Secretariat requests

The Commission replied to a number of information requests from the Rotterdam

Convention Secretariat, e.g. on the definition of pesticides, or information on exports,

export notifications and information exchange.

Following the 6

CoP, the Secretariat of the Convention asked that Parties complete

questionnaires on the exchange of information on exports between Parties, and whether

export notifications are being submitted by exporting Parties and acknowledged by

importing Parties. The Commission, as the EU DNA, prepared the answer to the

questionnaire on behalf of the EU and its Member States.

3.3. Financial contribution to the Rotterdam Convention

As a Party to the Rotterdam Convention, the EU contributes to the Convention’s Trust

Fund and Special Voluntary Trust Fund for the implementation of the programme of

work for technical assistance (see Table 7).

On its contribution to the Special Voluntary Trust Fund, the Commission works with the

Secretariat of the Convention to specify the content of the projects to be carried out in

cooperation with the beneficiary Parties. Those projects aim to assist Parties that are

developing countries or countries with economies in transition, in order to improve the

implementation of the Convention.

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Table 7

: Financial contributions from the EU to the Rotterdam Convention’s Trust Fund and Special

Voluntary Trust Fund (EUR)

Year

2014

2015

2016

EU Contribution to Trust Fund

51,195

55,474

54,582

EU Contribution to Special Voluntary

Trust Fund

277,331

302,815

513,603

3.4. Exchange of information (Article 20)

According to Article 20, the Commission, assisted by the Agency and the Member

States, must facilitate the provision of scientific, technical, economic and legal

information to other countries about chemicals subject to the PIC Regulation, including

toxicological, ecotoxicological and safety information.

The Commission provided an answer to two requests in the period 2014-2015



One from Peru, asking whether three mixtures were subject to an export

notification under the EU PIC Regulation.



One from Serbia, requesting clarification of provisions on mercury with respect to

Regulation 649/2012 and Regulation 1102/2008.

The Commission replied to four requests in 2016 from four countries (Canada,

Indonesia, Lebanon and Syrian Arab Republic) concerning four chemicals. In addition,

information was sent to Ecuador in response to a request.

From Rotterdam Convention website, amounts converted from USD to EUR at November 2017 rates.

ECHA,

Overview on the exchange of information under Article 20 of the PIC Regulation - Compilation of the

information collected by the European Commission, assisted by the Member States and the European

Chemicals Agency (ECHA),

2016, available at:

https://echa.europa.eu/documents/10162/21728206/pic_article_20_report_2014-2015_en.pdf/ad0e2b0d-

4f12-486f-b1da-9fd2ddbbb187