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
Date: 2022-09-13
Institutions: Directorate-General for Environment, European Commission
Subjects: European Chemicals Agency, application of EU law, chemical product, dangerous substance, environmental protection, exchange of information, export (EU), import (EU), information technology applications, public health

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 13.9.2022  SWD(2022) 218 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(2022) 412 final}  
 
 
Table of Contents 

1 

INTRODUCTION ....................................................................................................... 4 

1.1  The PIC Regulation ........................................................................................... 4 
1.2  The reporting exercise ....................................................................................... 5 
1.3  Methodology ..................................................................................................... 5 
Preparation of the Commission’s report .............................................. 5 
Implementation  of  the  common  format  for  reporting  for  Member 
States in the form of a web-based questionnaire ................................. 6 
Synthesis of Member States’ reporting ............................................... 7 
1.3.3 
1.3.4  Drafting the synthesis report and summary ......................................... 7 

1.3.1 
1.3.2 

2  GOVERNANCE OF THE PIC REGULATION ........................................................ 8 

2.1  Organisation of the implementation of the PIC Regulation .............................. 8 
European Commission ........................................................................ 8 
2.1.1 
European Chemicals Agency (ECHA) ................................................ 8 
2.1.2 
2.1.3  DNAs ................................................................................................. 11 

2.2  Coordination  between  the  Commission,  the  Agency  and  Designated 

National Authorities ........................................................................................ 14 
2.2.1  Coordination between DNAs and the Commission .......................... 14 
2.2.2  Coordination between DNAs and the Agency .................................. 14 
2.2.3  Coordination between the Agency and the Commission .................. 15 
2.3  The EU as a Party to the Rotterdam Convention ............................................ 16 

2.3.1  Coordination of Union input to the Conference of the Parties (CoP)

 ........................................................................................................... 17 
Participation in committees and expert groups ................................. 18 
Financial contributions to the Rotterdam Convention ...................... 20 

2.3.2 
2.3.3 

3  UPDATES OF ANNEX I AND ANNEX V TO THE PIC REGULATION ............ 21 

3.1  Update of Annex I ........................................................................................... 21 
3.2  Updates of Annex V ........................................................................................ 23 

4  OPERATION OF THE PIC REGULATION ........................................................... 25 

4.1.1 
4.1.2 

4.1  Support to exporters and importers ................................................................. 25 
Support provided by DNAs ............................................................... 25 
Support provided by the Agency ....................................................... 27 
4.2  Export notifications sent to Parties and other countries (Article 8) ................ 30 
4.2.1 
Export notifications processed during the reporting period .............. 30 
Special RIN requests processed during the reporting period ............ 33 
4.2.2 
4.2.3  Requests for resubmission and rejection of export notifications ...... 35 
4.2.4  Difficulties encountered in the export notification procedure........... 39 
Emergency situations (Article 8(5)) .................................................. 42 
4.2.5 
Provision of available additional information on exported chemicals
4.2.6 
 ........................................................................................................... 42 
4.2.7  Administrative fee for export notifications ....................................... 43 

1 

 
 
4.3  Export notifications from Parties and other countries (Article 9) ................... 43 
4.4 
Information on export and import of chemicals (Article 10) .......................... 44 
4.5  Notification of banned or severely restricted chemicals under the Convention 

(Article 11-12) ................................................................................................. 45 
4.6  Obligations in relation to importing chemicals (Article 13) ........................... 45 
4.7  Obligations  in  relation  to  exports  of  chemicals,  other  than  export 

notifications (Article 14) ................................................................................. 46 
4.7.1  Communication  of  information  and  decisions  to  those  concerned 

within the jurisdiction of a Member State (Article 14(3))................. 46 
4.7.2 
Explicit consent (Article 14(6)) ......................................................... 47 
4.7.3  Waivers (Article 14(6) and (7)) ......................................................... 48 
4.7.4  Validity of explicit consent (Article 14(8)) ....................................... 50 
Information on transit movement (Article 16) ................................................ 50 

4.8 
4.9  Requirements linked to exported chemicals and accompanying information 

(Article 17) ...................................................................................................... 51 
4.10  Enforcement of the PIC Regulation (Article 18) ............................................ 51 
4.10.1  National enforcement authorities (NEAs) ......................................... 52 
4.10.2  Training inspectors ............................................................................ 52 
4.10.3  Enforcement strategy ......................................................................... 53 
4.10.4  Enforcement activities ....................................................................... 53 
4.10.5  Powers of enforcement authorities .................................................... 56 
4.10.6 
Infringements during the reporting period ........................................ 57 
4.10.7  Penalties............................................................................................. 58 
4.10.8  Collaboration between DNAs and NEAs .......................................... 59 
4.10.9  Forum activities ................................................................................. 60 
4.11  Exchange of information (Article 20) ............................................................. 61 
4.12  Technical assistance (Article 21) .................................................................... 62 
4.13  IT-related aspects ............................................................................................ 65 
4.13.1  The ePIC system ................................................................................ 65 
4.13.2  User-friendliness of the ePIC system ................................................ 67 
4.13.3  Areas of improvement ....................................................................... 69 
4.13.4  Data dissemination ............................................................................ 70 

2 

 
 
 
 
Abbreviations used  

BPR 
CLP 
CN 
CoP 
CRC 
CUS 
DNA 
ECHA  
ePIC 
EU 
FRA 
NEA 
OECD  
PIC  
POPs 
PPPR   
REACH 

RIN 
SDS 
WPIEI 

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  
Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
Regulation  
Reference Identification Number  
Safety Data Sheet  
Council  Working 
(Chemicals/Synergies) 

International  Environmental 

Party 

Issues 

on 

3 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1  INTRODUCTION  

1.1  The PIC Regulation  

Regulation  (EU)  No  649/20121  (‘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. It goes beyond the requirements of the Convention since it 
applies to exports to all countries and requires the consent of the importing country for many 
more chemicals  than those listed under the Convention.  In addition,  the requirements for 
export also apply to certain mixtures containing listed chemicals. 

Under the PIC Regulation, exports are subject to different requirements depending on their 
listing in Annex I: chemicals listed in Part 1 of Annex I are subject to export notification to 
the importing country;  chemicals listed in Parts 2 and 3 of Annex I are subject to export 
notification and explicit consent 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. 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 1272/20082 (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, on behalf of the Union and based on the empowerment in the 
PIC  Regulation,  establishes  an  import  decision  that  outlines  whether  and  under  which 
conditions the chemical can be imported in the Union. This import decision is sent to the 
Secretariat of the Convention. 

1 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.  

2 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.  

4 

 
                                                 
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 second under the PIC Regulation and covers the period 2017-
2019. The questionnaire follows, as in  the first reporting exercise, the common reporting 
format for Designated National Authorities (DNAs), which was established by Commission 
Implementing Decision (EU) 2016/770 of 14 April 20163. The reporting questionnaire was 
however slightly revised to improve the user-friendliness of the questionnaire and the clarity 
of  some  of  the  questions.  The  online  reporting  questionnaire  was  made  available  to  the 
Member States on 9 June 2021, with a deadline for completion set to 27 August 2021. All 
reports  were  submitted  by  mid-November  2021.  The  Agency  published  its  report  on  the 
operation of the PIC Regulation4 for the period 2017-2019 in August 2020.  

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 and Member States. 
It provides an overview of the implementation of the PIC Regulation in the period 2017-
2019.  

1.3  Methodology 

1.3.1  Preparation of the Commission’s report 

The  Commission’s  report,  available  in  Annex  III,  is  divided  into  two  sections,  the  first 
section presenting the work of the Commission with respect to the implementation of the 
Regulation within the EU, and the second section presenting the international work of the 
Commission as the EU DNA to the Rotterdam Convention, during the period 2017-2019. 

To prepare this report, relevant information was compiled from EUR-Lex, the websites of 
the Rotterdam Convention and ECHA, and documents published on CIRCABC, including 
minutes  of  meetings,  and  other  documents  discussed  at  DNA  meetings  (Table  1).  Other 
information was obtained first-hand from Commission officials. This report was then used 
as a source for the synthesis report. 

3 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.  

4 ECHA (2020) Report on the operation of the Prior Informed Consent (PIC) Regulation. ECHA-20-R-10-EN.  

5 

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

List of relevant documents consulted  
Implementing and delegated acts  

  Commission Delegated Regulation (EU) 2018/172 of 28 November 2017 amending Annexes I and 

V to Regulation (EU) No 649/2012 (OJ L 32, 6.2.2018, p. 6–11).  

  Commission Delegated Regulation (EU) 2019/330 of 11 December 2018 amending Annexes I and 

V to Regulation (EU) No 649/2012 (OJ L 59, 27.2.2019, p. 1–7).  

  Commission Delegated Regulation (EU) 2019/1701 of 23 July 2019 amending Annexes I and V to 

Regulation (EU) No 649/2012 (OJ L 260, 11.10.2019, p. 1–7). 

  Commission Implementing Decision of 10 October 2018 laying down the final import response on 
behalf of the Union concerning the future import of certain chemicals pursuant to Regulation (EU) 
No 649/2012 (OJ C 376, 18.10.2018, p. 12–30).  

DNA meeting documents  

  Minutes of 29th, 30th, 31st, 32nd, 33rd and 34th DNA meetings, and meeting documents.  

Rotterdam Convention documents  

  PIC circulars published by the Rotterdam Convention. 

ECHA’s reports on Article 20 and the Operation of the PIC Regulation 

  Overview on the exchange of information under Article 20 of the PIC Regulation 2016-2017.  
  Report on the exchange of information under the PIC Regulation in years 2018-2019. 
  ECHA (2020) Report on the operation of the Prior Informed Consent (PIC) Regulation 2020. 

1.3.2  Implementation of the common format for reporting for Member States in the 

form of a web-based questionnaire 

Before the launch of the questionnaire, the consultant reviewed the questionnaire with a view 
to  increase  its  clarity  and  usability  for  DNAs.  As  the  reporting  format  had  been  adopted 
through a Commission Implementing Decision, most changes were limited to improving the 
format  or  wording  of  the  questions,  add  clarifications,  definitions  and  guidance  where 
needed  etc.  The  focus  of  the  revision  concerned  in  particular  questions  for  which  it  was 
identified in the previous reporting that Members had difficulty to answer, did not provide 
all expected information or provided inconsistent information. In the section on enforcement 
of the PIC Regulation, one question on infringements was also amended based on the work 
carried out by the Forum during the reporting period5. A summary of the changes made to 
the questionnaire is available in Annex V.  

The common reporting format was made available online to Member States on 9 June 2021, 
through EU Survey. A guidance document for Member States accompanied the invitation 
email.  

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.  

5 ECHA (2018) Final report of the Forum pilot project on the control of PIC, ECHA-2018-R-25-EN.  

6 

 
 
 
 
 
 
 
 
                                                 
  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.  

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 synthesis of the Member States’ reports is available in Annex IV.  

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, available in Annex II, follows the same structure as that of the synthesis report, 
presenting the key facts and conclusions from each section. 

7 

 
 
 
 
 
 
2  GOVERNANCE OF THE PIC REGULATION  

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  the  representation  of  the  Union  at  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  is  in  charge  of  the  PIC  Regulation.  Unit  B.2  –  safe  and  sustainable 
chemicals  has  one  policy  coordinator  responsible  for  carrying  out  the  Commission’s 
administrative functions under PIC. The policy coordinator is supported by a policy officer, 
a lawyer for legal questions and by a secretary for all organisational work. For international 
work, Unit B.2 had two experts (the policy coordinator and a policy officer) 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.2 (bilateral 
and regional environmental cooperation) contributed to the technical assistance contracts on 
implementation  of  the  Rotterdam  Convention  and  F.3,  responsible  for  multilateral 
environmental cooperation, contributed 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, 0.3 FTE for 
policy  officer/legal  officer,  and  0.1  FTE  for  the  supporting  work,  including  international 
matters. 

2.1.2  European Chemicals Agency (ECHA) 

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 importing country within 30 
days of the first notice (Article 8(3)). 

  Making available to all EU DNAs export notifications received from non-EU 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 importing 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)). 

8 

 
 
 
  Managing ePIC and keeping all relevant documents 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)). 

  Every  two  years,  compiling  and  publishing  the  information  transmitted  by  the 
Commission,  the  Member  States  and  the  Agency  to  the  authorities  in  non-EU 
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 contribute to the discussions at these meetings. 

In addition, the Agency provides assistance and technical and scientific guidance to industry, 
the  DNAs  from  Member  States  and  non-EU  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 (Table 2). Compared to the previous reporting period, ECHA 
has dedicated slightly more resources to the PIC Regulation during this reporting period (i.e. 
8 FTEs compared to 7 FTEs in 2014-2016).  

Table 2: Agency’s staff working on the PIC Regulation  

2017 
2018 
2019 

Number of staff working on PIC (FTE) 
8 
8 
8 

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: 

  Scientific, technical and regulatory support including: 

o  checking the identification of substances to be added to the PIC Regulation,  
o  checking compliance of Safety Data Sheets (SDS), 
o  checking the application of CLP rules, 
o  checking  the  regulatory  status  and  background  of  substances  under  BPR  or 

REACH, 

o  drafting  Final  Regulatory  Action  (FRA)  notifications  for  the  Rotterdam 

Convention Secretariat, in support to the Commission, 

o  having a member of the Agency nominated at the Chemical Review Committee 

(CRC) of the Rotterdam Convention, 

o  providing  support  to  stakeholders  (including  through  the  Helpdesk,  the 
publication/update  of  various  manuals,  guidelines  and  factsheets,  and 
communication actions, ECHA Newsletter, social media, etc.). 

  Development and maintenance of ePIC in order to benefit from synergies between 

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

  Making available of PIC data (dissemination); 

9 

 
 
 
 
 
 
 
 
  Planning,  data  mining  and  reporting  (i.e.  optimise  the  planning  and  reporting  of 

ECHA’s activities across the various legislations and activities); 

  Legal advice; 
  Human resources and finance. 

The Agency’s workload during the reporting period was in line with the predicted workload. 
As  highlighted  in  the  Agency’s  report,  the  number  of  export  notifications  processed  has 
continued to increase over the whole reporting period, in line with the predicted 10% yearly 
increase  (Table  3).  The  situation  contrasts  with  the  previous  reporting  period,  where  the 
Agency  had  reported  that  the  number  of  export  notifications  had  increased  beyond  the 
expected 10% annually.  

However, the continued increase in export notification has led, as in the previous reporting 
period, to an increase in processing tasks to be performed by the Agency and in stakeholder 
support  (e.g.  supporting  DNAs  or  responding  to  requests  for  clarification/additional 
information received from authorities in non-EU countries). Support provided by the Agency 
to the Commission, EU- and non-EU DNAs has taken approximately 30-40% of staff time 
during the reporting period (Table 4). This proportion is similar to what was reported for the 
period 2014-2016.  

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

No. of estimated notifications 
Actual no. of notifications  

2017 
8 900 
9 251 

2018 
10 700 
10 073 

2019 
11 400 
10 703 

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

No.  of  requests  for  technical/  regulatory 
support 

2017 
2 080 

2018 
2 550 

2019 
3 100  

The Agency has also dedicated human and financial resources to the enhancement of the 
ePIC application and in the automation of certain processes (to enable industry users and 
authorities  to  cope  with  a  higher  workload  and  meet  their  legal  obligations).  As  in  the 
previous reporting period, IT development remains a resource intensive part of the Agency’s 
work on the PIC Regulation.  

To cope with the uneven distribution of work during the calendar year (with a peak of export 
notification submissions during the winter months – October to January – which can make 
up for up to 70 % of the total yearly submissions), the Agency reported hiring interim staff 
for several months every year during the peak period. This situation was similar already in 
the previous reporting period.  

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.  According  to  Article  24(3),  the 
Commission must examine whether it is appropriate for the Agency to charge a fee for the 
services  provided to  exporters and, if so, submit a proposal.  The Commission  tendered a 
study in 2019 to fulfil this obligation. The study analysed the implementation of fee systems 
used by DNAs, analysed the costs of the different services provided by ECHA under the PIC 
Regulation and developed several options for a fee system, including an assessment of the 

10 

 
 
 
 
 
 
 
 
 
 
 
 
 
financial  and  technical  feasibility  and  appropriateness  of  the  options  for  the  different 
stakeholder groups impacted (ECHA, exporters, and DNAs), as well as of potential impacts 
on the overall implementation of the PIC Regulation and on trade. The study was completed 
in June 2020.  

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  38  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 performed by DNAs and can be divided 
in  four  categories:  administrative  tasks,  enforcement,  monitoring  and  reporting,  and 
exchange of information6.  

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)). 

 

  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. 

6 Adapted from: ECHA, Guidance for implementation of Regulation (EU) No 649/2012 concerning the export and import 
of hazardous chemicals, version 1.1, 2015.  

11 

 
 
 
 
 
                                                 
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  (20)  have  only  one  DNA,  while  8  have  2  or  3.  DNAs  are  mostly 
Ministries  or  agencies  responsible  for  environment,  chemicals,  and  health  or  health  and 
safety. In a few cases, Ministries responsible for economy, competition, consumption, labour 
or agriculture have been designated as competent authorities. Since the previous reporting 
exercise, two Member States have designated new DNAs (the Netherlands and Italy). 

In  five  Member  States  (out  of  eight)  that  have  more  than  one  DNA,  responsibilities  are 
divided between one DNA responsible for industrial chemicals and one DNA responsible 
for pesticides. In other cases, there is one main DNA responsible for the implementation of 
the Regulation (and in some cases delegated tasks to another authority).  Table 5 provides 
information on the distribution of responsibilities in Member States with several DNAs.  

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

Member States  
Greece  

Hungary  

Ireland 

Italy 

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 Department, Ministry of Rural 
Development and Food: responsible for pesticides 
National Public Health Center: responsible for industrial chemicals  
National Food Chain Safety Office: responsible for pesticides 
The Health and Safety Authority: responsible for industrial chemicals  
The Minister for Agriculture, Food and the Marine: responsible for pesticides 
The Revenue Commissioners: in respect of Article 18 of the PIC Regulation 
Ministry  of  Health:  responsible  for  the  implementation  of  the  PIC  Regulation  and 
cooperation with custom for enforcement activities 

12 

 
 
 
 
 
 
Member States  

Latvia 

Netherlands  

Slovakia 

United Kingdom 

the  correct  implementation/enforcement  of 

Distribution of responsibilities  
The  other  two  DNAs  (Ministry  of  ecological  transition  and  Ministry  economic 
development) do not perform any activities in the implementation of the PIC regulation 
(no  dedicated  human  resources  in  those  ministries).  The  Ministry  of  ecological 
transition is however the contact point for the Rotterdam Convention.  
Latvian  Environment,  Geology  and  Meteorology  Centre:  responsible  for  industrial 
chemicals 
State Plant Protection Service: responsible for pesticides  
Ministry of Infrastructure and Water Management: responsible for the policy area and 
for 
the  Regulation.  The  Human 
Environment  and  Transport  Inspectorate,  which  is  the  supervising  authority  of  the 
Ministry, is tasked with supervision.  
Tax  and  customs  administration:  administrative  tasks  related  to  ePIC  have  been 
delegated/commissioned  by  the  Ministry  to  the  Central  Import  and  Export  Office, 
which is part of the tax and customs administration.  
Ministry of Economy: responsible for industrial chemicals and pesticides 
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  
In practice, through an agreement between Great Britain and Northern Ireland all of 
the UK DNA work is carried out by the Great Britain DNA.  

Germany indicated that they have one DNA for the implementation of the PIC Regulation, 
but that regarding the Rotterdam Convention, there are two DNAs, one for pesticides and 
one for industrial chemicals.  

PIC  DNAs  in  all  Member  States  are  involved  in  the  implementation  of  other  EU  or 
international  chemicals  legislation,  convention  or  other  instrument  (Figure  1).  Nineteen 
DNAs are also responsible for the implementation of the REACH Regulation, 17 DNAs for 
the CLP Regulation, 12 for the POPs Regulation, 15 for the BPR, 8 for the PPPR and 8 for 
the Detergents  Regulation.  In 13 Member States, the PIC DNAs are also involved in  the 
implementation of the Basel, Rotterdam and Stockholm (BRS) Conventions. 

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

REACH

CLP

BPR

19

17

15

POPs Regulation

12

Detergents Regulation

PPPR

Mercury Regulation

6

0

2

8

8

4

6

8

10

12

14

16

18

20

Number of Member States

PIC  DNAs  reported  levels  of  resources  dedicated  to  the  implementation  of  the  PIC 
Regulation ranging from 0.1 to 2 FTEs. To the extent that comparison is possible (as some 
DNAs have reported resources in different units in both periods), resources have remained 
quite stable in many DNAs, with around eight reporting a decrease. 

13 

 
 
 
 
 
 
 
 
2.2  Coordination between the Commission,  the Agency and Designated 

National Authorities 

2.2.1  Coordination between DNAs and the Commission  

As  in  the  previous  reporting  exercise,  all  Member  States  considered  the  coordination 
between the DNAs and the Commission to be satisfactory. Member States mentioned that 
the support provided by the Commission to DNAs (especially answers to DNA questions) is 
quick and of good quality.  

The main areas of improvement, according to DNAs, are, as in the previous reporting, the 
obligation to monitor exporters’ compliance, shared by the Commission, the Agency and the 
DNAs  (Article  18(1))  and  the  update  of  annexes  (Article  23)  –  although  fewer  Member 
States mentioned those as areas to be improved compared to the period 2014-2016. Over 
half of the DNAs (15) replied that none of the proposed areas of coordination (listed in the 
question7) need to be improved. 

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  

As in the previous reporting exercise all Member States considered the coordination between 
the DNAs and the Agency to be satisfactory. Member States mentioned that the assistance 
provided  by  the  Agency  to  DNAs  is  appreciated  for  its  swiftness  and  quality  –  quick 
responses to questions, informal exchanges when needed, support on specific issues when 
raised, information about updated tools or guidance.  

DNAs generally considered that none of the proposed areas of coordination (listed in the 
question8)  required  improvements.  Areas  that  were  flagged  by  DNAs  as  needing 
improvements in the previous reporting exercise – Article 23, Article 21 and Article 8(7) – 
are this time only flagged by one or two Member States. 

According to the Agency, ECHA and the DNAs work together in a collaborative, efficient 
and friendly manner, and differences of views are discussed and solved easily. An illustration 
of the good cooperation, according to the Agency, is the one-day visit to ECHA of a small 
German DNA delegation in September 2019 as this allowed the teams to know each other 

7 Article 8(5) — export in case of an emergency situation; Article 8(7) — additional information to be provided on request 
concerning  the  exported  chemical;  Article  11(6)  —  Member  State  obligation  to  assist  the  Commission  in  compiling 
information; Article 11(7) — evaluation of the need to propose measures at Union level; Article 11(8) — procedure in case 
a Member State takes national final regulatory action; Article 13(6) — evaluation of the need to propose measures at Union 
level;  Article  14(1)  —  obligation  to  forward  information  received  from  the  Secretariat;  Article  14(5)  —  advice  and 
assistance to importing parties upon request; Article 14(6) — Member State decision that no explicit consent is required; 
Article 14(7) — Member State decision that export may proceed; Article 14(7) — Member State consideration of possible 
impacts on human health or environment; Article 14(8) — periodic review of the validity of explicit consent; Article 18(1) 
— Commission, Member State, ECHA obligation to monitor exporter compliance; Article 20 — exchange of information; 
Article 21 — technical assistance; Article 23 — updating annexes.  
8 Article 6(1)(c) — assistance and technical and scientific guidance and tools for the industry; Article 8(7) — additional 
information to be provided on request concerning the exported chemical; Article 11(6) — Member State obligation to assist 
the Commission in compiling information; Article 11(7)  — evaluation of the need to propose measures at Union level; 
Article 13(6) — evaluation of the need to propose measures at Union level; Article 20 — exchange of information; Article 
21 — technical assistance; Article 23 — updating annexes.  

14 

 
 
 
 
 
                                                 
better, to exchange on the respective working approaches and methods, and to discuss some 
specific issues that were more difficult to address in written communication. According to 
the Agency, it would be useful to replicate such visits with other Member States.  

However,  the  Agency  indicated  that  there  are  areas  in  which  the  collaboration  could  be 
smoother and more efficient. Those areas include 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. Those areas of improvements are the same as those mentioned in the 
previous Agency’s report for the period 2014-2016.  

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 
information sheets produced by the Agency (for instance, the information sheet on waivers9) 
and to the work of the Forum on Exchange of Information on Enforcement, in particular to 
the  pilot  project  on  the  control  of  PIC  duties,  carried  out  by  the  Forum  in  201810.The 
Commission contributed to the project manual drafted by the Forum, which was then used 
by Member States for implementation of the project.  

Regarding  the  cooperation  with  non-EU  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.  

As  in  the  previous  reporting  period,  the  Agency  indicated  that  the  coordination  with  the 
Commission  is  generally  satisfactory.  The  Agency  welcomed  the  establishment  of  more 
regular contacts between the Agency’s PIC Operations Team and the Commission, such as 
regular  teleconferences,  every  six  weeks  in  average,  to  discuss  ECHA’s  PIC-related 
tasks/activities.  The  Agency  indicated  that  those  teleconferences  could  be  usefully 
complemented by more regular and informal contacts. 

The  Agency  however  indicated  that  coordination  and  cooperation  with  the  Commission 
could be improved in some areas:  

  Preparation  of  FRA  notifications  to  the  Rotterdam  Convention  Secretariat: 
According  to  the  Agency,  the  regular  teleconferences  have  improved  the 
predictability and planning of this work. However, the planning of the work could be 
further  improved  and  the  efficiency  could  be  increased  by  agreeing  on  near-term 
deadlines  for  the  Commission  to  provide  comments  on  notifications  drafted  by 
ECHA. 

  Technical  preparation  of  meetings:  Regarding  PIC  DNA  meetings,  the  Agency 
indicated that there is potential for better planning and stronger collaboration in the 
identification  of  agenda  items,  the  preparations  of  the  discussions  and  the 
development of the related supporting meeting documents. This would both help the 

9 Proposing waivers through ePIC: https://echa.europa.eu/proposing-waivers-through-epic  
10 ECHA (2018) Final report of the Forum pilot project on the control of PIC.  

15 

 
 
 
 
 
 
                                                 
Commission make the most of ECHA’s insights and support a better planning and 
use of the Agency’s resources. The need for stronger collaboration in the preparation 
of  DNA  meetings  was  already  highlighted  by  the  Agency  in  its  previous  report. 
Regarding  their  participation  in  the  Chemical  Review  Committee  meetings  (i.e. 
ECHA provided an expert from  mid-2017 to  mid-2019 to  the member seat  of the 
United Kingdom), the Agency highlighted the good cooperation between ECHA, the 
Commission,  other  EU  participants  and  other  CRC  members,  but  noted  that  the 
workload  was  higher  than  estimated  and  than  initially  agreed  between  the 
Commission and ECHA.  

  Article 14(6) and (7) on decisions that the export can proceed in the absence of 
an explicit consent: regarding this process, the Agency makes a similar point as in 
the previous report. The final check performed by ECHA at the time of the activation 
of the related export notification leads in certain cases (circa 20 cases per year in the 
reporting period) to the revision of the initial decision, which in turn often triggers 
requests for clarification addressed to ECHA by the exporters due to the delay in the 
activation of the export notification. According to ECHA, the processing of waiver 
proposals may be delayed due to limited resources at the Commission to perform the 
task, while ECHA would have the capacity to process them within a maximum of 2 
working  days.  The  Agency  considers  that  it  would  simplify  the  procedure  and 
improve the overall efficiency of the waivers process, if the Agency played an earlier 
and enhanced role in the waiver approval process.  

  Article 23 on updating annexes: The Agency is now involved at an earlier stage in 
the process of amending the Annexes I and V to the PIC Regulation, which was a 
request from the Agency in the previous reporting period. The Agency considers this 
change has  been valuable both  in  ensuring consistency in substance identification 
and improving planning. According to the Agency, it could however support further 
the  Commission,  in  particular  with  regards  to  the  prioritization  of  candidate 
substances for their inclusion in Annex I (and Annex V) to the PIC Regulation. The 
Agency proposes to work with the Commission to investigate how ECHA could most 
appropriately support the Commission in that area. ECHA also recommends that it 
becomes standard practice to adopt amendments to Annex I (and Annex V) early in 
the  year  so  that  they  enter  into  force  before  the  end-of-year  annual  export 
notifications’  submission  peak.  This  was  done  during  this  reporting  period  and 
reduced the burden on all actors.  

  Day-to-day  exchanges  between  the  Agency  and  the  Commission:  The  Agency 
recommends that the Commission establishes a proper backing-up system to ensure 
that ECHA can reach a PIC contact at the Commission, and ensure a smooth running 
of PIC operations, at all times, including in the summer period, during which the PIC 
operations continue (and may sometimes see increased workload due to e.g. the entry 
into application of an amendment to the list of substances subject to PIC). 

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 

16 

 
 
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.  

2.3.1  Coordination of Union input to the Conference of the Parties (CoP) 

During the reporting period, the 8th Conference of the Parties to the Rotterdam Convention 
took place from 24 April to 05 May 2017, and the 9th CoP, from 29 April to 10 May 2019.  

CoP-8 (24 April to 05 May 2017)  

Replying to an invitation of the Secretariat, the Commission submitted comments on behalf 
of the European Union on the listing in Annex III of chemicals that had been recommended 
by the CRC for listing. Those comments were agreed in WPIEI before their submission. 

The  Commission  contributed  to  the  drafting  of  EU  and  its  Member  States  comments  on 
amendments proposed by other Parties, i.e. the proposals to amend Articles 16 and 22 of the 
Convention.  Those  comments  were  agreed  in  WPIEI  and  submitted  to  the  Secretariat  on 
behalf of the EU and its Member States. 

Before the CoP, the Commission prepared a proposal for a Council Decision establishing 
the position to be adopted on behalf of the European Union within the Conference of the 
Parties with regard to amendments of Annex III to the Rotterdam Convention (COM(2017) 
73 final), to get the mandate for the participation in the decision-making at the CoP. The 
proposal was submitted to the Council in February 2017 and adopted on 3 April 2017.  

In addition, the Commission contributed to the drafting of the position papers of the EU and 
its Member States and to the corresponding statements for their participation in the CoP. The 
position papers and statements cover all agenda items of the meeting. 

Before the 8th meeting of the CoP, the Commission also consulted DNAs on the possibility 
to  organise  meetings  at  the  8th  Conference  of  the  Parties  between  the  European  Union, 
Member States, and other Parties, following the positive experience of such meetings at the 
7th meeting of the CoP.  

During the CoP, the Commission represented the EU and the EU and its Member States in 
contact groups and in any bilateral meetings with Parties, the Secretariat of the Convention 
and other stakeholders, and contributed to the drafting of Conference Room Papers. 

After CoP-8, the Commission presented the outcomes of the CoP to DNAs at the 30th DNA 
meeting on 3 October 2017. 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 19 
June 2017.  

17 

 
 
 
 
 
 
 
 
 
 
 
CoP-9 (29 April to 10 May 2019)  

Before the CoP, 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:  

  Proposal for a Council Decision establishing the position to be adopted on behalf of 
the European Union within the Conference of the Parties with regard to amendments 
of Annex III to the Rotterdam Convention (COM(2019) 54 final) to get the mandate 
for the participation in the decision-making at the CoP. The proposal was submitted 
to the Council in February 2019 and adopted on 15 April 2019.  

  Comments on amendments proposed by Parties – proposals to amend Articles 16 and 

22 of the Convention,  

  Comments on the report on legal and operational implications of priority actions to 
enhance  the  effectiveness  of  the  Rotterdam  Convention,  prepared  by  a  working 
group.  

  Commission proposal for a Council Decision on the position to be taken on behalf of 
the European Union at the Conference of the Parties to the Rotterdam Convention 
regarding compliance procedures, regarding the proposal to be discussed at the CoP 
to  adopt  an  additional  procedural  annex  in  order  to  introduce  a  non-compliance 
mechanism as required by Article 17 of the Convention. 

As for the previous CoP, the Commission contributed to the drafting of the position papers 
of the EU and its Member States and to the corresponding statements for their participation 
in the CoP. The position papers and statements cover all agenda items of the meeting. 

During the CoP, the Commission represented the EU and the EU and its Member States in 
contact groups and in any bilateral meetings with Parties, the Secretariat of the Convention 
and other stakeholders, and contributed to the drafting of Conference Room Papers. As for 
the previous CoP, and based on the positive experience with  the meetings held  at  CoP-8 
between the European Union and its Member States and some groups of other Parties, the 
Commission consulted DNAs on the organisation of such meetings during CoP-9.  

After CoP-9, the Commission presented the outcomes of the CoP to DNAs at the 34th DNA 
meeting on 15 October 2019. The Commission also submitted, together with the Presidency, 
an information  note on the outcomes  of the CoP to  the Rotterdam,  Basel and Stockholm 
Conventions, transmitted by the General Secretariat of the Council to the delegations on 26 
June 2019.  

2.3.2  Participation in committees and expert groups 

Chemical review committee (CRC)  

During  the  reporting  period,  five  or  six  EU  Member  States  had  nominated  experts  to 
participate  in  the  13th,  14th  and  15th  meetings  of  the  CRC  (including  the  expert  from  the 
United Kingdom, which was a member of the EU during the reporting period) (Table 6). In 
the 13th meeting of the CRC, in October 2017, two EU representatives acted as Chair and 
Vice-chair: Mr Jürgen Helbig from the Commission, nominated by Spain (Chair) and Ms 
Magdalena Frydrych, nominated by Poland (Vice-chair).  

18 

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

CRC meetings 
CRC-13, October 2017 

CRC-14, September 2018 

CRC-15, October 2019 

EU Members of the CRC  
Germany 
Netherlands 
Poland (Vice-chair)  
Spain (Chair) 
United Kingdom  
Finland 
Germany 
Latvia 
Malta 
Poland 
United Kingdom 
Finland 
Germany 
Latvia 
Malta 
Poland 
United Kingdom 

Intersessional work on enhancing the effectiveness of the Rotterdam Convention 

Following the intersessional work on the process of listing chemicals in  Annex III to the 
Convention and to develop options for improving the effectiveness of the listing process and 
information flows, which was carried out by a working group between the 7th and the 8th 
meeting  of  the  CoP,  the  CoP  reviewed,  during  the  8th  meeting,  options  to  improve  the 
effectiveness  of  the  Rotterdam  Convention,  agreed  on  further  work  to  be  done  in  the 
intersessional period and established a working group to identify priority actions to improve 
the effectiveness of the Convention.  

Twelve EU experts (11 from Member States and one from the Commission) were nominated 
to this intersessional working group:  

  One expert from the Federal Ministry for Sustainability and Tourism (Austria); 
  One  expert  from  the  Federal  Public  Service  Health,  Food  Chain  Safety  and 

Environment (Belgium); 

  One expert from the European Commission; 
  Two experts from the Federal Ministry for the Environment, Nature Conservation, 

Building and Nuclear Safety (Germany); 

  One  expert  from  the  Ministry  of  Environmental  Protection  and  Regional 

Development (Latvia); 

  Two experts from the Ministry of Infrastructure and Environment (Netherlands); 
  One expert from the Bureau for Chemical Substances (Poland); 
  One expert from the Swedish Chemicals Agency (Sweden); 
  Two experts from the Department for Environment, Food and Rural Affairs (Defra), 

United Kingdom. 

After the 8th CoP, the Secretariat of the Convention developed an online survey to be filled 
by  Parties  by  31  October  2017  to  gather  information  on  priority  actions  to  enhance  the 
effectiveness  of  the  Convention.  The  Commission,  as  the  EU  DNA,  coordinated  the  EU 
submission  –  preparing  the  draft,  inviting  DNAs  to  comment,  and  submitting  the  final 
response to the Secretariat.  

Following the survey, the working group made a compilation of submissions and drafted a 
report on the legal and operational implications of priority actions proposed to enhance the 

19 

 
 
 
 
 
 
 
effectiveness of the Rotterdam Convention. The Commission coordinated the submission of 
EU comments on some of these suggestions. Financial support for the intersessional work 
was also provided by the Commission. 

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 (Table 7).  

Table 7:  Financial contributions from the EU to the Rotterdam Convention’s Trust Fund and Special 
Voluntary Trust Fund (in EUR, converted from USD to EUR with the exchange rate of the 
time of payment/commitment) 

Year 

2017 
2018 
2019 

EU contribution to Trust Fund11 

EU  contribution  to  Special  Voluntary  Trust 
Fund12 

62 512 
63 316 
68 661 

336 750 
551 000 

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 contributed to  the Special Voluntary Trust 
Fund (Table 8).  

Table 8: Member States’ contributions to the Special Voluntary Trust Fund (EUR) 13 

Member State 
France 
Germany 
Netherlands 

2014 
0 
39 475 
36 408 

2015 
100 616 
40 477 
35 214 

2016 
0 
0 
0 

11 The contributions published on the Convention website are calculated in USD. These are the amounts paid in EUR.  
12 Commitments in accordance with the agreement concluded with the Secretariat of the Convention in the respective 
year.  
13 From the Rotterdam Convention website, amounts converted from USD to EUR at January 2022 rates.  

20 

 
 
 
 
 
 
 
 
 
 
                                                 
3  UPDATES OF ANNEX I AND ANNEX 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 the PIC Regulation. The procedure 
for  adoption  of  delegated  acts  requires  the  Commission  to  consult  experts  on  draft 
amendments. 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. 

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.  

Amendments  to  Part  3  of  Annex  I  reflect  the  decisions  of  the  CoP  to  include  certain 
chemicals in Annex III to the Convention, making them subject to the PIC procedure. 

During the reporting period, three Delegated Regulations amending Annex I were adopted, 
in 2017, 2018 and 2019:  

  Commission Delegated Regulation (EU) 2018/172 of 28 November 2017 amending 
Annexes I and V to Regulation (EU) No 649/2012 (OJ L 32, 6.2.2018, p. 6–11).  
  Commission Delegated Regulation (EU) 2019/330 of 11 December 2018 amending 
Annexes I and V to Regulation (EU) No 649/2012 (OJ L 59, 27.2.2019, p. 1–7).  
  Commission  Delegated  Regulation  (EU)  2019/1701  of  23  July  2019  amending 
Annexes I and V to Regulation (EU) No 649/2012 (OJ L 260, 11.10.2019, p. 1–7).  

Substances added to Annex 1  

Of the 37 substances added to Annex I during the reporting period, 23 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’,  as  shown  in  Table  9.  Three 
substances were added to Parts 1 and 2 of Annex I following their non-approval for use in 
biocidal products in accordance with the BPR (Regulation (EU) No 528/2012). Five were 
added  to  Parts  1  and  2  of  Annex  I  because  they  were  severely  restricted  as  industrial 
chemicals for public use under the REACH Regulation. Finally, six were included in Part 3 
of Annex I following their inclusion in Annex III to the Rotterdam Convention. 

21 

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

Delegated Act 

Chemical  

CAS number 

Commission 
Delegated  Regulation 
(EU)  2018/172  of  28 
November 
2017 
amending  Annexes  I 
and  V  to  Regulation 
(EU) No 649/2012 

3-decen-2-one 
5-tert-butyl-2,4,6-trinitro-
m-xylene 
Benzyl butyl phthalate 
Carbendazim 
Cybutryne 
Diisobutyl phthalate 
Diarsenic pentaoxide 
Tepraloxydim 
Triclosan 
Triflumuron 
Tris 
phosphate 
Methamidophos 

(2-chloroethyl) 

10519-33-2 
81-15-2 

85-68-7 
10605-21-7 
28159-98-0 
84-69-5 
1303-28-2 
149979-41-9 
3380-34-5 
64628-44-0 
115-96-8 

Amendment  of 
Annex I 
Parts 1 and 2 
Parts 1 and 2 

Basis 
inclusion  
PPPR 
REACH 

for 

Parts 1 and 2 
Part 1 
Parts 1 and 2 
Parts 1 and 2 
Parts 1 and 2 
Parts 1 and 2 
Parts 1 and 2 
Part 1 
Parts 1 and 2 

REACH 
PPPR 
BPR 
REACH 
REACH 
PPPR 
BPR 
BPR 
REACH 

10265-92-6 

Parts 1 and 3 

Commission 
Delegated  Regulation 
(EU)  2019/330  of  11 
2018 
December 
amending  Annexes  I 
and  V  to  Regulation 
(EU) No 649/2012 

Amitrole 
Beta-cypermethrin 
Carbofuran 

61-82-5 
65731-84-2 
1563-66-2 

Parts 1 and 2 
Parts 1 and 2 
Parts 1 and 3 

459 

KE 

DPX 
(flupyrsulfuron-methyl) 
Fipronil 
Iprodione 
Isoproturon 
Linuron 
Maneb 
Orthosulfamuron 
Picoxystrobin 
Short-chain 
paraffins 

chlorinated 

150315-10-9 
144740-54-5 
120068-37-3 
36734-19-7 
34123-59-6 
330-55-2 
12427-38-2 
213464-77-8 
117428-22-5 
85535-84-8 

Parts 1 and 2 

Parts 1 and 2 
Parts 1 and 2 
Parts 1 and 2 
Parts 1 and 2 
Parts 1 and 2 
Parts 1 and 2 
Parts 1 and 2 
Part 3 

Triasulfuron 
Trichlorfon 

82097-50-5 
52-68-6 

Parts 1 and 2 
Parts 1 and 3 

Commission 
Delegated  Regulation 
(EU) 2019/1701 of 23 
July  2019  amending 
Annexes  I  and  V  to 
Regulation  (EU)  No 
649/2012 

2-naphthyloxyacetic acid  
Acetochlor 
Asulam 

Chloropicrin 
Diphenylamine 
Flufenoxuron 
Naled 
Propanil 
Propargite 
Alachlor 

120-23-0 
34256-82-1 
3337-71-1 
2302-17-2 
76-06-2 
122-39-4 
101463-69-8 
300-76-5 
709-98-8 
2312-35-8 
15972-60-8 

Part 2  
Parts 1 and 2 
Parts 1 and 2 

Parts 1 and 2 
Part 2 
Parts 1 and 2 
Parts 1 and 2 
Part 2 
Parts 1 and 2 
Part 3 

Aldicarb 

116-06-3 

Part 3 

Endosulfan 

115-29-7 

Part 3 

Annex III 
Rotterdam 
Convention 
PPPR 
PPPR 
Annex III 
Rotterdam 
Convention  
PPPR 

PPPR 
PPPR 
PPPR 
PPPR 
PPPR 
PPPR 
PPPR 
Annex III 
Rotterdam 
Convention  
PPPR 
Annex III 
Rotterdam 
Convention  
PPPR 
PPPR 
PPPR 

PPPR 
PPPR 
PPPR 
PPPR 
PPPR 
PPPR 
Annex III 
Rotterdam 
Convention  
Annex III 
Rotterdam 
Convention  
Annex III 
Rotterdam 
Convention  

22 

 
 
 
Substances included in Part 3 of Annex I during the reporting period, with the exception of 
short-chain chlorinated paraffins, had already been included in Parts 1 and 2 of Annex I to 
the PIC Regulation. Following their inclusion in Annex III to the Convention, corresponding 
entries in Part 2 of Annex I were deleted and entries in Part 1 of Annex I were amended 
accordingly.  

The  substance  methamidophos  (CAS  no  10265-92-6)  was  included  in  Annex  III  to  the 
Convention. As a result, the existing entry in Annex III to the Convention concerning that 
substance ‘methamidophos (soluble liquid formulations of the substance that exceed 600 g 
active  ingredient/l)’  was  deleted  and  replaced  by  a  new  entry  for  ‘methamidophos’. 
Commission  Delegated  Regulation  (EU)  2018/172  deleted  the  existing  entry  in  Part  2  of 
Annex I, and replaced the existing entries in Parts 1 and 3 of Annex I by a new one, reflecting 
the changes made to Annex III to the Convention.  

Entries of Annex I modified during the reporting period  

Tributyltin compounds were already included in Annex III to Convention in the use category 
‘pesticide’ since 2008. In 2017, the CoP included tributyltin compounds in Annex III in the 
use  category  ‘industrial’.  As  a  result,  tributyltin  compounds  became  subject  to  the  prior 
informed consent procedure under the Convention in the use category ‘industrial’ as well as 
‘pesticide’. In addition, tributyltin compounds were added in 201714 to substances covered 
by Entry 30 of Annex XVII to REACH (restriction on substances which are classified as 
reproductive toxicant category 1A or 1B listed in appendices to the Annex). Commission 
Delegated Regulation (EU) 2019/330 replaced existing entries in Parts 1 and 3 of Annex I 
to the PIC Regulation by new entries, reflecting changes made under the Convention and the 
REACH Regulation.  

Entries  concerning  dichlorvos  in  Parts  1  and  2  of  Annex  1  to  the  PIC  Regulation  were 
amended  by  Commission  Delegated  Regulation  (EU)  2019/1701  to  reflect  Commission 
Decision 2012/254/EU not to include dichlorvos in Annex I, IA or IB to Directive 98/8/EC, 
which results in dichlorvos being banned from pesticide use.  

Substances removed from Annex I  

By  Implementing  Regulations  (EU)  No  582/2012  and  (EU)  No  359/2012,  bifenthrin  and 
metam were approved, respectively, under the PPPR, with the effect that those substances 
were no longer banned from pesticide use. As a result, the entries concerning bifenthrin and 
metam were deleted from Part 1 of Annex I.  

3.2  Updates of Annex V  

Amendments to Part 1 of Annex V to the PIC Regulation (chemicals subject to export ban) 
are triggered by the inclusion of a substance in Annex I to the POPs Regulation (Regulation 
(EU) 2019/102115). During the reporting period, the following substances were added to Part 
1 of Annex V (Table 10).  

14 Commission Regulation (EU) 2017/1510 of 30 August 2017 amending the Appendices to Annex XVII to Regulation 
(EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH) as regards CMR substances. OJ L 224, 31.8.2017, p. 110–114.  
15  Regulation  (EU)  2019/1021  of  the  European  Parliament  and  of  the  Council  of  20  June  2019  on  persistent  organic 
pollutants, OJ L 169, 25.6.2019, p. 45–77.  

23 

 
 
 
 
 
                                                 
Table 10: Substances added to Part 1 of Annex V during the reporting period  

Chemical 
Hexachlorobutadiene 
Polychlorinated naphthalenes 
Hexabromocyclododecane 

Tetrabromodiphenyl ether 
Pentabromodiphenyl ether 
Hexabromodiphenyl ether 
Heptabromodiphenyl ether 
Short-chain chlorinated paraffins 

CAS number 
87-68-3 
70776-03-3 and others 
25637-99-4,  3194-55-6,  134237-
50-6,  134237-51-7,  134237-52-8 
and others 
40088-47-9 and others 
32534-81-9 and others 
36483-60-0 and others 
68928-80-3 and others 
85535-84-8 

Endosulfan 

115-29-7 

Commission 
Delegated 
Regulation  (EU)  2018/172  of  28 
November 
amending 
2017 
Annexes  I  and  V  to  Regulation 
(EU) No 649/2012 

Commission 
Delegated 
Regulation  (EU)  2019/330  of  11 
amending 
2018 
December 
Annexes  I  and  V  to  Regulation 
(EU) No 649/2012 
Commission 
Delegated 
Regulation (EU) 2019/1701 of 23 
July  2019  amending  Annexes  I 
and  V  to  Regulation  (EU)  No 
649/2012 

Part 2 of Annex V to the PIC Regulation lists chemicals subject to export ban other than 
POPs. To reflect changes brought by Regulation (EU) 2017/852, which modifies the rules 
on  the  export  of  mixtures  of  metallic  mercury  with  other  substances  with  a  mercury 
concentration  of  less  than  95  %,  and  of  certain  mercury  compounds,  entries  in  Part  2  of 
Annex V concerning such mercury compounds and mixtures were amended by Commission 
Delegated Regulation (EU) 2019/330.  

24 

 
 
 
 
 
 
4  OPERATION OF THE PIC REGULATION  

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-seven  Member  States  stated  that  they  had  carried  out  awareness-raising  and 
information activities for exporters and importers during the reporting period (Figure 2). The 
Member  State  that  did  not  carry  out  any  such  activities  is  a  small  Member  State,  which 
explained that this was due a limited number of PIC notifications in the country. 

As  in  the  previous  reporting  period,  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  (22  Member  States),  and  references  to  the  Agency’s 
webpages  on  PIC  and  ePIC  (22  Member  States).  Eleven  Member  States  also  provided 
helpdesk  services  via  an  existing  helpdesk  (e.g.  REACH,  CLP,  BPR)  and  six  operate  a 
national  helpdesk;  ten  Member  States  indicated  having  a  specific  email  address  for 
information requirements  

As  in  the  previous  reporting  exercise,  almost  all  of  the  Member  States  that  carried  out 
awareness-raising  considered  they  have  improved  exporters’  and  importers’  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, improvements in the quality 
of export notifications, an increase in the number of companies registered in ePIC or using 
ePIC,  or  improved  compliance  with  the  Article  10  reporting  obligations,  including 
compliance with reporting deadlines.  

25 

 
 
 
 
 
 
 
 
 
 
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?  

22

22

Specific web page providing information on the PIC
Regulation

Reference to ECHA webpages on PIC and ePIC

Helpdesk services via an existing helpdesk (e.g.
REACH, BPR, CLP)

Specific email address for information requirements

Others

Operating a national helpdesk

Workshops and similar training events

11

10

9

6

5

Visits to operator establishments

4

Online technical and scientific guidance (other than
ECHA's)

2

Awareness-raising campaign

1

0

5

10

15

20

25

Number of Member States

Requests from exporters and importers  

As in the previous reporting period, the most frequent requests from exporters and importers 
to DNAs relate to export notifications and explicit consents (Figure 3).  

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

Article 10 reporting

Special RIN

Waiver

Others

1

0

6

5

6

4

4

3

4

22

24

14

9

5

10

15

20

25

30

Number of Member States

2017-2019

2014-2016

Estimated amount of time spent on support  

In the majority of Member States, support to exporters and importers takes up to10% or 20% 
of the DNA’s workload (Figure 4). Compared to the previous reporting, significantly less 
Member States selected the option ‘up to 10% of the workload’, and more selected ‘20% of 
workload’, which may indicate that the time spent on support to exporters and importer has 
slightly increased since the previous reporting in some Member States. One Member State 

26 

 
 
 
 
 
 
 
 
 
 
also selected ‘more than 40% of workload’, which had not been selected in the period 2014-
2016. However, there has also been some decrease in workload, as the three Member States 
that  selected  ‘40%  of  workload’  in  the  previous  reporting  (Poland,  Romania  and  Spain) 
indicated this time that support took 30% of their workload. More Member States selected 
‘not quantifiable’ than in the previous reporting. 

Figure 4: Question 14: Can you estimate the amount of time spent by the DNA(s) on such support? 

up to 10 % of workload

20 % of workload

30 % of workload

40 % of workload

more than 40 % of workload

Not quantifiable

3

3

2

1, BG

0

0

8, CY, EE, FR, EL, HU, IE, IT, SE 

16

7, AT, BE, DE, FI,  FI, HR, 
LV, SI

5, CZ, DK, ES, PL, RO

4

7, LT, LU, MT, NL, PT, 
SK UK

0

2

4

6

8

10

12

14

16

18

Number of Member States

2017-2019

2014-2016

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:  

Webpages on the PIC Regulation and ePIC  

The Agency has published and translated webpages on the PIC Regulation and ePIC on the  
Agency’s website:  

  General introduction to the PIC Regulation 
  ePIC  

The direct links to all linguistic versions of the PIC Regulation legal texts (initial text, latest 
consolidated version, and non-consolidated latest amendments) are also made available and 
kept up-to-date under the section ‘Legislation’ of the Agency’s website.  

The  Agency  also  publishes  on  its  website  the  ‘PIC  Circular’  issued  twice  a  year  by  the 
Secretariat of the Rotterdam Convention.  

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 (e.g. Article 10 reporting 

deadline); 

  To alert  or remind exporters of typical  shortcomings  or elements  they should  pay 

attention to in their export notifications; 

27 

 
 
 
 
 
 
 
 
 
 
  To advertise the publication of updated user manuals, new factsheets, etc.; 
  To inform of policy changes (e.g. following an agreement at a PIC DNA meeting); 
  To alert users in advance of maintenance breaks of ePIC. 

Awareness-raising campaign 
The Agency reminds exporters and importers of PIC-related issues, such as upcoming legal 
deadlines,  new  or  clarified  legal  obligations  (such  as  entry  into  application  of  a  new 
amendment to Annex I and/or Annex V, new substances included in existing group entries), 
or  expected  workload  peaks,  using  different  communication  means,  including  the  ECHA 
Weekly News (by email) or the ECHA Newsletter. These channels were also used to make 
the promotion of ad hoc activities such as the campaign for improving the quality of the 
information provided in Section 2 (Prohibited and Allowed uses) of export notifications. 

Social media 
Since January 2018, ECHA has started to be more active on social media (LinkedIn, Twitter, 
Facebook) and published various posts relating to the implementation of the PIC Regulation, 
either for general awareness-raising purposes or on specific topics, such as the publication 
of  ECHA’s  Article  10  reports,  BREXIT,  the  ECHA  Forum  enforcement  project  on  PIC, 
ECHA’s participation  in the meetings of the Parties to  the Rotterdam  Convention, or the 
publication of specific guidelines on how to provide information on prohibited and allowed 
uses in PIC export notifications. 

Support to individual companies 
This support was mainly provided by the Agency by means of replies to incoming Helpdesk 
incidents. When needed (e.g. communication/language issues), the Agency also provided ad 
hoc support over the phone, usually as a follow-up to initial exchanges via the Helpdesk. 

Workshops, webinars and similar training events 
During  the  reporting  period,  ECHA  has  not  organised  any  specific  in-house  workshops, 
webinars or training events. However, the Agency has participated in several conferences 
during which the PIC Regulation and/or ePIC tool were presented and discussed with the 
participants from industry mainly.  

IT user manuals, factsheets and Q&A (FAQs)  
ECHA has regularly updated the ‘ePIC User manual for Industry’16, in order to reflect the 
successive  improvements  and  new  features  brought  to  the  ePIC  tool.  ECHA  is  also 
publishing and regularly updating specific ePIC User Manuals for DNAs, for NEAs, for the 
Commission, and an ePIC User Guide for Customs17.  

ECHA published during the reporting period four different guidelines (“In brief”  
documents) to assist exporting and importing companies on the following key aspects for 
the fulfilment of their obligations under the PIC Regulation: 

  Special RIN requests (August 2017), 
  Proposing waivers though ePIC (November 2017), 
  Reporting on exports and imports of PIC chemicals (December 2017), 
  How  to  provide  information  on  prohibited  and  allowed  uses  in  PIC  export 

notifications (October 2018). 

16 ECHA (2018) ePIC User Manual for Industry.  
17 ECHA, ePIC manuals.  

28 

 
 
 
 
 
 
 
 
                                                 
In addition, in 2018, ECHA conducted a major review of the existing legal texts developed 
by the Agency in three Rotterdam Convention languages (EN, ES, FR), with a focus on the 
texts for the 70 most exported PIC chemicals. ECHA provided these in ePIC for the exporters 
to use in Section 6.1 (Summary of and reasons for the final regulatory action and date of 
entry into force) of their export notifications. 

Finally, in March 2019, ECHA established a temporary manual procedure for notifying PIC 
exports to the UK after UK’s withdrawal. ECHA published a guideline on “How to notify 
PIC exports to the UK after the UK’s withdrawal from the EU”, as well as some related PIC-
specific information and Q&As, and a manual export notification form, until such export 
notifications can be made in the ePIC tool. 

The effectiveness of the communication activities can be seen in the increasing number of 
companies registered in ePIC: 1177 registered companies at the end of the previous reporting 
period (2014-2016) versus 2343 registered companies at the end of this reporting period, of 
which 578 actively used ePIC in  2019.  According to  the Agency,  the increased visibility 
given  to  PIC  by  ECHA  (via  information  on  ECHA’s  website,  news  items,  ECHA’s 
participation in conferences, social media, etc.) has contributed to increasing awareness and 
compliance with the PIC Regulation. 

Requests from exporters and importers  

The number of requests received during the reporting period by the Agency helpdesk from 
exporters and importers remained relatively stable compared to year 2015 and 2016 (2014 
was not a full year). However, a notable increase can be observed in 2019, which may be 
linked to the entry into force of amendments to Annex I (Table 11).  

Table 11: Number of requests received by ECHA from exporters and importers since 2014 

Year 
2014 
2015 
2016 

Nb of requests 
123 
245 
227 

Year 
2017 
2018 
2019 

Nb of requests 
230 
234 
283 

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

  Misunderstandings  regarding  the  export  notification  and  related  procedures:  e.g. 
exporters’ obligations under PIC depending on which part of Annex I their chemical 
is listed in, legal deadlines for processing the notification, misunderstanding of when 
export notifications are needed or not needed, and about the information required to 
be provided in certain sections of the notification.  

  Definitions/ concepts of ‘exporter’ and transit under PIC: which country should be 
notified when the exporter is located one Member State and the shipment leaves from 
another, how to deal with situations where when the manufacturer is based in a non-
EU country but the chemicals are shipped from the EU.  

  Substance identification: whether a substance is subject to PIC or not.  
  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 (banning of exports of metallic mercury), 
the triggering of labelling obligations for mixtures under CLP, or the consequences of the 
withdrawal of the United Kingdom from the EU for PIC exports to the UK (e.g. when and 

29 

 
 
 
 
 
 
 
 
 
how to notify the exports/imports to the UK). These questions often require seeking support 
outside the helpdesk, from expert colleagues in the Agency or the Commission.  

The questions related to the ePIC tool and its functionalities have always remained low in 
number (less than 10 per year) and not representative of any major issue. With the exception 
of Brexit, which is new, issues on which exporters and importers have asked for support are 
generally the same as in the previous reporting period.  

Estimated amount of time spent on such support  

During  this  reporting  period,  there  has  been  in  average  six  members  (FTEs)  of  the  PIC 
Operations Team in the Submission and Processing Unit (A3) who are directly involved in 
providing replies  to  the  requests received from  companies via the ECHA Helpdesk.  This 
represents an increase of two FTEs compared to the previous reporting period, where four 
FTEs  were  part  of  Unit  A3.  As  in  the  previous  reporting  period,  they  spent  on  average, 
approximately 10 % of their time on this specific activity (for this reporting period 0.6 FTE). 

4.2  Export notifications sent 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 2017 and 
2019,  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 the filling of section 6.2 of the notification form (Prohibited 
and Allowed uses). 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.  

4.2.1  Export notifications processed during the reporting period18  

During the reporting period, DNAs accepted and forwarded to the Agency  28 489 export 
notifications,  compared  to  15  771  notifications  in  the  previous  reporting  period,  which 
represent an increase of 81%. The number of notifications accepted and forwarded by DNAs 

18 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.  

30 

 
 
 
 
 
 
                                                 
has continuously increased since 2014, although the increase per year is less steep than in 
the previous reporting period (Figure 5).  

Figure 5:  Total number of export notifications accepted and forwarded to the Agency by DNAs per year 

since 201419 

9884

10083

8352

8522

d
n
a

d
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c
a

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E

A
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o
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r
a
w
r
o
f

12000

10000

8000

6000

4000

2000

0

5866

1553

2014

2015

2016

2017

2018

2019

The number of export notifications processed varies significantly between Member States 
(Figure 6). Four Member States did not process any export notification during the reporting 
period (Cyprus, Greece, Luxembourg and Malta) and two Member States processed fewer 
than 10 notifications. The highest numbers of export notifications during the reporting period 
were,  as  in  the  previous  reporting  period,  in  Germany  (8  645  notifications)  and  France 
(6 855), followed by Italy (2 453), Spain (2 383) and the UK (2 207).  

Figure 6:  Total number of export notifications accepted and forwarded to the Agency by DNAs during 

the reporting period  

10000

BE; 2019

1000

AT; 783

DE; 8645

FR; 6855

IT; 2453

A
H
C
E

o
t

100

BG; 227

DK; 193

CZ; 102

FI; 102

HR; 106

HU; 86

IE; 63

d
e
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r
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r
o
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d
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i
f
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t
r
o
p
x
E

10

1

EE; 1

Member  States

NL; 1029

PL; 661

ES; 2383

UK; 2207

SE; 293

LV; 28

LT; 17

PT; 141

SI; 74

SK; 14

RO; 7

19 For 2014 the period covered is 1 March – 31 December (as the PIC Regulation became applicable on 1 March 2014). 

31 

 
 
 
 
 
 
 
                                                 
 
 
 
 
 
 
 
 
 
 
 
 
 
Twenty  Member  States  processed  more  export  notifications  during  this  reporting  period 
compared to the previous one. In nine Member States, the number of notifications processed 
more than doubled between the two reporting periods. Five Member States saw a decrease 
in  the  number  of  notifications  processed  and  in  two  Member  States,  the  number  of 
notifications processed remained the same (Table 12).  

Table 12:  Total number of export notifications accepted and forwarded to the Agency by DNAs in the 

reporting periods 2014-2016 and 2017-2019  

Member State 

Export notifications accepted and forwarded to ECHA 

Austria 

Belgium 

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 

2014-2016 
361 

766 

107 

47 

4 

55 

115 

1 

93 

3358 

5196 

1 

29 

30 

1321 

0 

38 

0 

8 

588 

232 

58 

7 

46 

0 

1265 

216 

1829 

2017-2019 
783 

2019 

227 

106 

0 

102 

193 

1 

102 

6855 

8645 

0 

86 

63 

2453 

28 

17 

0 

0 

1029 

661 

141 

7 

14 

74 

2383 

293 

2207 

The Agency also reported an increase in the number of export notifications accepted and 
processed during the reporting period, from 8 455 in 2017, to 9 704 in 2018, to 10 009 in 
201920(Table 13). As mentioned in section 4.1.2, this increase is correlated to the increase 
in the number of companies involved in PIC activities (1177 companies registered in ePIC 
at the end of the previous reporting period (2014-2016); 2343 registered companies at the 
end of this reporting period, of which 578 actively used ePIC in 2019).  

20 Figures provided for the Agency include initial submissions, re-submissions and rejections. 

32 

 
 
 
 
 
                                                 
Table 13: 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 

2017 
8 455 

6 950 
4 583 
2 367 

2018 
9 704 

7 530 
5 062 
2 468 

2019 
10 009 

8 059 
5 387 
2 672 

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. These reminders are managed by ePIC automatically 
so that there is no impact on ECHA’s workload.  

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, DNAs accepted and forwarded to the Agency 11 327 Special 
RIN requests, compared to 7 072 requests in the previous reporting period, which represent 
an increase of 60%. The number of Special RIN requests accepted and forwarded by DNAs 
has continuously increased since 2014 (Figure 7).  

Figure 7: Total number of Special RIN requests accepted by DNAs per year since 2014 

3922

4146

3259

2961

2641

d
n
a

d
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l

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4500

4000

3500

3000

2500

2000

1500

1000

500

0

1470

2014

2015

2016

2017

2018

2019

The number of Special RIN requests processed varies significantly between Member States. 
As in the previous reporting period, eleven Member States did not have to deal with any 

33 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Special RIN requests in 2017-2019 (Bulgaria, Cyprus, Estonia, Greece, Latvia, Lithuania, 
Luxembourg, Malta, Portugal, Romania, and Slovakia). Germany, Belgium and France were 
the Member States that accepted the highest number of Special RIN requests (Figure 8).  

Figure 8: Total number of Special RIN requests accepted by DNAs during the reporting period  

d
n
a

d
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l

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S

A
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f

10000

1000

BE; 1897

AT; 600

DE; 4896

FR; 1171

100

HR; 101

IT; 101

HU; 279

PL; 418

UK; 885

ES; 623

SE; 140

SI; 122

10

1

CZ; 41

DK; 9

NL; 39

IE; 4

FI; 1

Member States

Thirteen Member States processed more Special RIN requests during this reporting period 
compared  to  the  previous  one,  although  the  extent  of  the  increase  varies  greatly  across 
Member States (from an increase of 8% in the UK to an increase of 264% in Austria). Six 
Member States saw a decrease in the number of requests processed (Table 14).  

Table 14:  Total number of Special RIN requests accepted and forwarded to the Agency by DNAs in the 

reporting periods 2014-2016 and 2017-2019 

Member State 

Export notifications accepted and forwarded to ECHA 

Austria 

Belgium 

Bulgaria 

Croatia 

Cyprus 

Czech Republic 

Denmark 

Estonia 

Finland 

France 

Germany 

Greece 

Hungary 

Ireland 

Italy 

2014-2016 
165 

1156 

0 

33 

0 

44 

13 

0 

5 

577 

3121 

0 

0 

29 

46 

2017-2019 
600 

1897 

0 

101 

0 

41 

9 

0 

1 

1171 

4896 

0 

279 

4 

101 

34 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Member State 

Export notifications accepted and forwarded to ECHA 

Latvia 

Lithuania 

Luxembourg 

Malta 

Netherlands 

Poland 

Portugal 

Romania 

Slovakia 

Slovenia 

Spain 

Sweden 

United Kingdom 

2014-2016 
0 

2017-2019 
0 

0 

0 

0 

29 

226 

5 

0 

164 

0 

555 

82 

822 

0 

0 

0 

39 

418 

0 

0 

0 

122 

623 

140 

885 

4.2.3  Requests for resubmission and rejection of export notifications  

Member States requested the resubmission of 5 889 export notifications during the reporting 
period, compared to  2904 requests for resubmission  during the previous  reporting period 
(Figure 9). The increase between the two reporting periods is likely the consequence of the 
increase in the number of export notifications accepted by DNAs (see section 4.2.1).  

Figure 9: Total number of resubmissions of export notifications requested by DNAs per year since 2014 

2734

1814

1481

1341

1022

s
A
N
D
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d
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R

3000

2500

2000

1500

1000

500

0

401

2014

2015

2016

2017

2018

2019

As  in  the  previous  reporting  period,  variations  between  Member  States  in  the  number  of 
resubmissions requested correspond to variations in the number of notifications handled, i.e. 
Member  States  that  handle  a  high  number  of  notifications  are  also  generally  those  that 
request resubmissions more frequently (Figure 10).  

35 

 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 10:  Total number of resubmissions of export notifications requested by DNAs in the reporting 

period 

10000

1000

BE; 305

100

AT; 115

ES; 1365

DE; 1125

FR; 1066

IT; 766

FI; 37

DK; 35

IE; 70

HU; 20

BG; 12

CZ; 6

LT; 5

HR; 2

n
o
i
s
s
i

m
b
u
s
e
r

r
o
f

s
t
s
e
u
q
e
R

10

1

0

PL; 306

UK; 502

PT; 56

SE; 40

NL; 36

SI; 16

SK; 4

5

10

15

20

25

Member States

As in the previous reporting period, the main reasons for requesting the resubmission of a 
notification were that information requirements were not met or issues with the SDS attached 
to export notification. More specifically, Member States reported the following reasons for 
requesting resubmission: 

 

Incorrect  filling  of  section  6.2  (10  Member  States):  errors  in  allowed  uses, 
inadequacy of the information provided on prohibited uses and lack of clarity on the 
use of the exported chemical; issues with section 6.2 ‘The final regulatory action has 
been  taken  for  the  category’  (one  Member  State  mentioned  confusion  with  3.3 
‘Foreseen category and foreseen use in importing country’); 
  SDS not provided in the right language (7 Member States); 
  Missing contact information (7 Member States), in particular provision of PO box 

instead of physical address; 

  Absence or issues with  SDSs (6 Member States), issues were related to  SDSs not 
corresponding  to  the  notified  substance  or  mixture,  or  notification  and  SDSs  not 
consistent with regard to substance percentages in mixtures, or SDSs were attached 
as "Other document"; 
Incorrect filling of section 6.1 (2 Member States); 
Identification of the substance (2 Member States): incorrect name of mixture, wrong 
concentrations; 

 
 

  Wrong notification under emergency situation (1 Member State): wrong reason for 

 

notifying (emergency situation) to avoid the 35-day period; 
Invalid notifications (1 Member State): different notifications for equally classified 
substances/mixture, duplicated notifications; 

  Expected export date has to be extended (1 Member State).  

The Agency requested the resubmission of 2 758 export notifications during the reporting 
period, compared to 609 during the period 2014-2016 (Figure 11). As above, the increase 
corresponds to an increase in the number of export notifications handled by the Agency. The 
trend  is  similar  to  that  of  resubmission  requested  by  DNAs  –  with  a  peak  in  2018  and 
decreases in the last year of the reporting period, 2016 and 2019.  

36 

 
 
 
 
 
 
 
 
Figure 11: Number of resubmissions requested by the Agency per year since 201421.  

A
H
C
E

y
b

d
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1400

1200

1000

800

600

400

200

0

1251

937

570

334

232

43

2014

2015

2016

2017

2018

2019

In 2017, most of the resubmissions were requested following the adoption by ECHA of a 
stricter approach in checking the content of export notifications, with the aim to ensure that 
the information in the notifications and the attached SDSs are provided at an appropriate 
level of quality and language to the authorities of the importing countries. In 2018 and 2019, 
most of the resubmissions were requested because of unclear or irrelevant information under 
section  6.2  (Prohibited  and  Allowed  uses),  which  is  also  the  main  reason  mentioned  by 
DNAs. Many notifications for which resubmission was requested in 2018 also had incorrect 
or insufficient contact details for the non-EU importers under Section 3.4, or not matching 
with the destination country (reason which was also mentioned by seven DNAs). In 2019, 
many notifications were sent back because of inconsistencies between the concentration of 
the PIC substance in the mixture as stated in the export notification (Section 2.5) and in the 
attached Safety Data Sheet. 

Member  States  rejected  544  export  notifications  during  the  reporting  period,  which  is 
significantly  less  than  in  the  previous  reporting  period,  where  1,214  notifications  were 
rejected  by  DNAs.  Following  a  peak  of  notifications  rejected  in  2016,  the  number  of 
notifications rejected has continuously decreased during the reporting period (Figure 12).  

21 For 2014, data was only available after go-live of the PIC submission system (2 September 2014).  

37 

 
 
 
 
 
 
 
                                                 
 
 
 
Figure 12: Total number of export notifications rejected by DNAs per year since 2014  

831

d
e
t
c
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j
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s
n
o
i
t
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i
f
i
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o
N

900

800

700

600

500

400

300

200

100

0

357

26

229

172

143

2014

2015

2016

2017

2018

2019

As  above,  variations  between  Member  States  in  the  number  of  notifications  rejected 
correspond  to  variations  in  the  number  of  notifications  handled,  i.e.  Member  States  that 
handle a high number of notifications are also generally those that reject notifications more 
frequently (Figure 13).  

Figure 13: Total number of export notifications rejected by DNAs during the reporting period  

s
A
N
D
y
b

d
e
t
c
e
j
e
r

s
n
o
i
t
a
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i
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i
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N

1000

100

10

1

ES; 104

FR; 105

DE; 110

BE; 48

AT; 25

IT; 49

IE; 11

NL; 27

PL; 15

UK; 30

DK; 3

CZ; 2

LT; 2

SI; 2

PT; 3

HR; 4

FI; 1

HU; 1

Member States

LV; 1

SE; 1

As in the previous reporting period, the main reason reported by DNAs to reject a notification 
is  the  duplication  of  notifications,  which  was  mentioned  by  ten  Member  States.  Other 
reasons mentioned were that the notification was not applicable because the right to receive 
the  notification  was  waived  by  the  importing  country,  or  the  resubmission  was  late  (one 
Member State) or the company contacted the DNA and informed that the export notification 
was submitted incorrectly.  

Unlike DNAs, the Agency rejected more notifications (212) during the reporting period than 
in the period 2014-2016 (175 notifications), mostly because of a peak in the last year of the 
reporting period, 2019. Such a peak in the last year of the reporting could already be observed 
in the previous reporting period, in 2016 (Figure 14).  

38 

 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 14: Number of export notifications rejected by the Agency per year since 2014  

A
H
C
E

y
b

d
e
t
c
e
j
e
r

s
n
o
i
t
a
c
i
f
i
t
o
N

140

120

100

80

60

40

20

0

124

122

51

41

49

0

2014

2015

2016

2017

2018

2019

In 2017, most of the rejections were made at exporters’ request (e.g. exports cancelled; one 
already  validated  notification  could  cover  similar  mixtures  for  which  other  export 
notifications are not needed). The main reason for rejecting the export notifications in 2018 
was that the importing country has waived the right to receive export notifications for certain 
chemicals  from  the  EU  (Brazil);  another  representative  reason  for  rejection  was  that  the 
concentration  of  the  PIC  substance  in  the  export  notification  did  not  trigger  labelling 
obligations under CLP. In 2019, most of the rejections were due to unnecessary duplicate 
notifications; there were other various reasons such as the selection of the wrong template 
for the notification (e.g. mixture instead of pure substance) or a mismatch between the stated 
importing country and the importer’s address. 

4.2.4  Difficulties encountered in the export notification procedure  

Difficulties encountered by exporters in completing the export notification form 

According  to  the  DNAs,  exporters  have  mainly  experienced  difficulties  to  provide 
information on the intended use of the chemical in the importing country, and to a lesser 
extent on the availability of CN codes or CUS codes, and on the export itself, such as the 
contact details of the importer. The top three information requirements are the same as in the 
previous reporting period. Compared to the previous reporting, the number of Member States 
replying ‘none’ has significantly increased (Figure 15). 

39 

 
 
 
 
 
 
 
 
 
 
Figure 15:  Question  19.  What are  the  information  requirements  requested  in  the  export  notification 

form where exporters have difficulties in providing the information?  

10

10

12

12

12

8

8

Intended use of the chemical in the importing
country

None

5

Availability of CN codes or CUS codes

Information concerning the export (e.g. contact
details of importers)
Summary of and reasons for the final regulatory
action and date of entry into force
Information on the final regulatory action taken
by the European Union
Additional information provided by the exporting
Party

Identity of the mixture to be exported

Summary of physico-chemical, toxicological and
ecotoxicological properties
Information on hazards or risks of the chemical
and precautionary measures

Identity of the substance to be exported

Identity of the article to be exported

7

5

5

6
6

4

4

3

1

1

1

0

2

2

3

3

0

2

4

6

8

10

12

14

Number of Member States

2017-2019

2014-2016

In addition to these issues, DNAs highlighted issues with the language of SDSs and with 
intended uses reported by Member States.  

When processing export notifications, ECHA has noticed the following issues/ mistakes:  

  Duplication of notifications. 
 

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 for mixtures and use 

the wrong template. 

  Section  3.3  of  the  export  notification  (foreseen  category  and  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. 
  The foreseen uses in the importing country under Section 3.3 are often inadequately 
described, in particular due to the fact that the field is provided as free text only, and 
therefore without any structured sub-categorization of uses. 

  The prohibited uses and allowed uses described under Section 6.2 are often incorrect 
or misleading, and reflecting more the intended uses in the importing country than 
the regulatory status of uses within the EU. 

  The “Produced / Imported / Exported / Used” fields under Section 6.2 are usually left 
empty, but often filled in with incorrect data too, sometimes referring to quantities 
that are specific to the exporter instead of quantities that are to be reported at EU 
level. 

40 

 
 
 
 
 
  Not  all  companies  provide  the  SDS  (or  equivalent  information)  in  the  official 
language of the importing country or in an appropriate language. ECHA has however 
noticed  some  improvement  with  regard  to  this  issue,  and  in  particular  since  new 
features were added in ePIC to raise the attention of the exporters. 

According to the Agency and the DNAs, section 6.2 is one of the sections of the notification 
for which exporters experience most difficulties in providing the requested information. It is 
also one of the main reasons for resubmission requests. Therefore the Agency suggests to 
explore the possible ways and means to improve the overall efficiency and usefulness of the 
information provided under this sub-Section, namely through improved data structure. Since 
these information requirements in ePIC are derived from Article 8, paragraph 2 and Annex 
II to the PIC Regulation, necessary changes to the PIC Regulation legal text may however 
be  needed.  Depending  on  the  changes  considered,  adaptations  to  ePIC  and  to  the  export 
notification template as sent to importing countries, may be required too. 

Section 3.3 is another section of the export notification that is also often incorrectly filled by 
exporters according to the Agency and DNAs. To address the issue, the Agency suggests 
integrating  a  more  detailed  and  structured  sub-categorization  of  foreseen  uses  could  be 
introduced in the formats for export notifications in ePIC. Adaptations to ePIC and to the 
export notification template as sent to importing countries, would however be required. 

Complying with timeframes  

According to the Agency, DNAs experienced difficulties in coping with the timeframe to 
forward  the  export  notifications  to  ECHA,  as  shown  by  the  increasing  number  of  late 
notifications.  As  shown  in  Table  15,  the  number  of  export  notifications  forwarded  late 
remains relatively low compared to the total number of notifications processed (6.3% of the 
total number of notifications).  

Table 15: Number of export notifications received late by the Agency since 2014  

Year 
2014 
2015 
2016 
2017 
2018 
2019 
Total 2014-2016 
Total 2017-2019 

Number of late notifications 
6 
348 
371 
312 
880 
594 
725 
1786 

% of total yearly number of notifications 
1.2% 
6.4% 
4.7% 
3.7% 
9.1% 
5.9% 
4.9% 
6.3% 

ECHA  has  noticed  that  the  difficulties  of  certain  Member  States  to  cope  with  the  legal 
timeframe for the checking export notifications usually appears during and right after peak 
submission periods, i.e. in November/December/January months, and especially when those 
coincide with holiday periods when very limited or no resources are available. 

Three  Member  States  (compared  to  seven  in  the  previous  reporting  period)  reported 
difficulties in complying with a timeframe to forward the notifications to the Agency. Those 
three Member States are among the Member States that process the largest number of export 
notifications (France, Germany and Italy). Two of them explained that companies often do 
not  respect  deadlines  for  resubmission,  making  it  difficult  for  the  DNA  to  forward  the 
notification to ECHA according to the set timeframe. All three Member States mentioned 

41 

 
 
 
 
 
 
 
 
 
the  difficulties  to  manage  the  notifications  in  compliance  with  the  timeframe  during  the 
‘peak season’ (October to January/February).  

As in the previous reporting period, the Agency indicated that it experienced difficulties in 
coping  with  the  timeframe  to  process  and  forward  export  notifications  to  the  importing 
country. The number of late notifications remains very low (0.2%) even though it increased 
since the previous reporting period (see Table 16). According to the Agency, the delay, in 
many cases, because the tasks had been already processed late by the DNA and therefore 
ECHA received the task very close to the due date. For a number of cases, it was the Agency 
(and not the Member State DNA) who missed its legal deadline for processing, typically due 
to IT-related issues or a need for policy consultation. In case of delays, the authority in the 
importing country has always been informed accordingly. 

Table 16: Number of export notifications processed late by the Agency since 2014 

Year 
2014 
2015 
2016 
2017 
2018 
2019 
Total 2014-2016 
Total 2017-2019 

Number of late notifications 
3 
18 
9 
14 
42 
4 
30 
60 

% of total yearly number of notifications 
0.7 
1.4% 
1.1% 
0.2% 
0.4% 
0.04% 
1.2% 
0.2% 

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.  During  the  reporting  period,  received  15  export 
notifications  flagged  as  referring  to  the  export  of  a  chemical  related  to  an  emergency 
situation. According to the Agency, most of them (13) did not meet the criteria described in 
Article  8(5)  and,  when  available,  were  providing  justifications  relating  to  economic 
considerations  rather  than  to  the  protection  of  public  health  or  the  environment.  In  those 
cases,  the  Agency  rejected  the  notification  and  invited  the  company  to  submit  a  new 
‘standard’ export notification. The Agency however notes that the exporter’s DNA should 
have  rejected  the  notification  instead  of  forwarding  it  to  ECHA.  Only  two  export 
notifications were validated as per Article 8(5) during the reporting period.  

Only one Member State (United Kingdom) had to deal with an emergency situation during 
the reporting period (in 2019). The emergency situation was related to Ethylene oxide for 
sterilization purposes (in the health system) in Cuba and the Member State had no difficulties 
implementing the procedure.  

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. As 
in the previous reporting period, the Agency received a relatively high number of requests 
from  authorities  in  non-EU  importing  countries  to  provide  additional  information  or 

42 

 
 
 
 
 
 
 
 
clarifications  on  exported  chemicals.  As  in  the  previous  reporting  period,  these  requests 
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.  

Five DNAs (compared to eight in the previous reporting period) received similar requests. 
Information  requested  by  the  importing  countries  related  primarily  to  importer  contact 
details. One DNA also mentioned having provided general information related to labelling 
and other similar issues, including through Customs Officials.  

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.  As  in  the  previous  reporting  period,  eight  Member 
States  have  requested  an  administrative  fee  for  export  notifications  (Belgium,  Bulgaria, 
Finland, Germany, Greece, Hungary, Portugal, and Slovenia), and these fees vary greatly 
between Member States (from EUR 25 to EUR 265). Fee amounts have not changed since 
the previous reporting period.  

Four  Member  States  have  established  a  fee  for  requests  for  explicit  consent  (Bulgaria, 
Finland,  Germany  and  Portugal).  In  the  previous  reporting  period,  Bulgaria  was  not 
requesting a fee. In Finland, Germany, and Portugal, the amount of the fee has not changed 
since the previous reporting period, varying from EUR 25 to EUR 265. 

As  in  the  previous  reporting  period,  Member  States  have  received  no  complaints  from 
exporters on the amount of the fees, nor did they note any significant impact of the fees 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 non-EU 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  371  export  notifications  from  non-EU  countries  in  the  reporting 
period, which is slightly higher than in the previous reporting period (1 105 notifications) 
(see  Table  17).  The  number  of  notifications  almost  remained  stabled  over  the  reporting 
period.  

Table 17:  Export notifications received from non-EU countries and acknowledgements sent during the 

reporting period  

Export notifications received  
Acknowledgements sent 

2017 
448 
95 

2018 
465 
92 

2019 
458 
95 

Total  
1 371 
282 

43 

 
 
 
 
 
 
 
 
 
 
 
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 United States of America (USA), based on a bilateral agreement, while the 
USA is the country sending the greatest number of export notifications to the EU, based on 
their national legislation and notwithstanding that the USA is not a Party to the Convention.  

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.  As in the previous 
reporting period, their responses suggest that the reporting under Article 10 works well.  

Delays in collecting information  

Seven Member States  (compared to  ten in  the previous reporting period)  stated that  they 
experienced delays from exporters in the submission of information on the quantity of the 
chemical  exported,  requiring  to  send  reminders.  Five  of  these  seven  Member  States  had 
already reported delays in the previous reporting period. Five Member States (compared to 
eight  in  the  previous  reporting  period)  indicated  that  they  had  experienced  delays  from 
importers in submitting their information. As in the previous reporting period, the Agency 
did  not  encounter  delays  from  DNAs  in  receiving  the  aggregated  national  reports  on  the 
quantity  of  exported  and  imported  chemicals,  suggesting  that  delays  from  exporters  and 
importers did not affect the completion of the reporting exercise under Article 10. 

Reporting through ePIC  

Only two Member States reported difficulties or delays in doing their article 10 reporting 
through  ePIC,  caused  by  delays,  mistakes,  or  incorrect  contact  details  in  exporters  / 
importers’ reporting.  

Aggregating information at EU level  

According  to  the  Agency,  reporting  from  DNAs  has  improved  compared  to  the  previous 
reporting period as less  DNAs reported data that are out of scope of Article 10 reporting 
(such as data on exports of PIC chemicals exported for research and analysis purposes below 
10kg per year and per importing country). However, some of the data submitted by DNAs 
contained errors derived from industry reporting and required correction, re-aggregation and 
resubmission  of  the  reports  by  the  DNAs.  According  to  the  Agency,  this  has  led  to 
inefficiencies and delays in the preparation of the overall report as well as to errors not being 
identified by ECHA and published, as ECHA’s capacity to perform a quality check is very 
limited. The Agency therefore recommended that DNAs increase verification of aggregated 
data before submission.  

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 15 Member States (which is roughly similar to the previous 

44 

 
 
 
 
 
 
 
reporting period where 16 Member States had replied that they used this data). Five DNAs 
specifically mentioned the data is used by customs authorities. Seven DNAs indicated that 
the data are used for enforcement activities, with two specifying that it is used for checking 
compliance with REACH 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 and other stakeholders for comments before submitting them 
to the Secretariat. Ten notifications were submitted to the Secretariat during the reporting 
period:  

  Acetochlor (2017)  
  Amitrole (2019) 
  Beta-cypermethrin (2019) 
  Cybutryne (2019) 
  Flupyrsulfuron-methyl (2019) 
 
Iprodione (2019) 
 
Isoproturon (2019) 
  Orthosulfamuron (2019) 
  Picoxystrobin (2019) 
  Triasulfuron (2019) 

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  Union  import  decision  is  adopted  by  means  of  an 
implementing act of the Commission. The Commission services draft 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 one Implementing Decision in 2018 
(see Table 18). The Implementing Decision provided new import decisions for carbofuran, 
trichlorfon, short-chain chlorinated paraffins, tributyltin compounds and amended the import 
decision on ethylene oxide.  

Article 13(5) requires the DNAs to make EU import decisions available to those concerned 
within their competence. As in the previous reporting exercise, DNAs fulfil this requirement 
by email and by publishing those decisions on their website.  

45 

 
 
 
 
 
 
 
 
Table 18: EU import responses adopted during the reporting period  

Implementing 
Act 
Commission 
Implementing 
Decision  of  10 
October 2018 

Chemicals 

Carbofuran 

/ 

Nature 
decision  
1563-66-2 

Trichlorfon 

52-68-6 

Short-chain 
chlorinated paraffins 

85535-84-8 

status 

of 

New 
decision 
New 
decision 
New 
decision 

Tributyltin 
compounds  

Ethylene Oxide  

56-35-9; 
1983-10-4; 
2155-70-6; 
4342-36-3; 
1461-22-9; 
24124-25-2; 
85409-17-2 
75-21-8 

Import 
decision 
Final  

Grounds for decision 

No consent to import 

Final  

No consent to import 

Final  

New 
decision 

Final  

Consent to import only 
subject 
to  specified 
conditions 
Consent to import only 
subject 
to  specified 
conditions 

Modificat
ion 

Final 

Consent to import only 
to  specified 
subject 
conditions 

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 late or no response from some importing countries 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 is still challenging to implement Article 14(8), the number of problematic cases 
has been substantially reduced.  

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.  As  in  the  previous  reporting  period,  all  DNAs  fulfil  this 
requirement,  mainly  through  emails  and  the  provision  of  information  on  their  website 
(Article 14(3)).  

46 

 
 
 
 
 
 
4.7.2  Explicit consent (Article 14(6))22 

Nineteen Member States (as in the previous reporting period) sought explicit consent from 
the DNA of the importing country, under Article 14(6)(a) of the PIC Regulation. A total of 
5 058  requests for explicit consent were processed by DNAs between 2017 and 2019, which 
is  higher  than  in  the  previous  reporting  period  where  3  362  requests  were  processed  by 
DNAs.  As  in  the  previous  reporting  period,  the  Member  States  that  have  processed  the 
highest number of requests are Germany, France, Belgium, Spain, the United Kingdom and 
the  Netherlands  (Figure  16).  In  15  Member  States  (out  of  19),  the  number  of  requests 
processed by the DNA was higher than in the previous reporting period. In some cases, the 
increase is quite significant (e.g. from 283 requests in 2014-2016 to 872 in 2017-2019 in 
Belgium, from 559 to 1045 in France, from 10 to 54 in Ireland, from 47 to 80 in Poland, or 
from 4 to 37 in Slovenia).  

Figure 16: Number of requests for explicit consent received by DNAs during the reporting period  

t
n
e
s
n
o
c

t
i
c
i
p
x
e

r
o
f

s
t
s
e
u
q
e
R

10000

1000

BE; 872

FR; 1045

DE; 1658

ES; 368

NL; 271

UK; 319

100

IT; 106

SE; 117

PL; 80

CZ; 19

DK; 20

IE; 54

FI; 33

HU; 22

HR; 14

SI; 37

10

AT; 16

LT; 4

SK; 3

1

Member States

Of the 5 058 requests for explicit consent, 54% received responses following either the initial 
request, the first or the second reminder, which is a roughly similar response rate compared 
to the previous reporting period. In 23 % of cases, the response is received after the first 
reminder (see Table 19). Despite an overall response rate that remains rather low, the system 
of reminders – of which the vast majority is triggered and sent automatically – is considered 
as effective and efficient by the Agency.  

Table 19: Reminders for explicit consent requests sent by the Agency during the reporting period  

2017 
2018 
2019 
Total  

First reminder  
1 100 
983 
1 280 
3 363 

Second reminder  
849 
788 
963 
2 600 

22 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. 

47 

 
 
 
 
 
 
 
 
                                                 
 
 
 
During  the  reporting  period,  there  were  14  instances  in  Germany  and  Spain  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 20). 

Table 20: Number of requests for explicit consent pursuant to Article 14(6)(b)23  

Member State 
Germany 
Spain 

2017 
1 
4 

2018 
2 
7 

2019 
0 
0 

Total 
3 
11 

Difficulties encountered in the implementation of the explicit consent procedure  

Ten Member States  reported having  experienced  difficulties in  implementing the  explicit 
consent  procedure.  As  in  the  previous  reporting  period,  the  main  challenge  reported  by 
DNAs 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. To improve the processing of 
requests  for  explicit  consent,  one  DNA  suggested  that  it  would  be  useful  for  processing 
DNAs  to  receive  an  email  alert  from  ePIC  indicating  when  responses  to  explicit  consent 
requests have not been received after 30 and 60 days so the DNA can advise companies in 
relation to waivers.  

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). As in the previous reporting period, the 
Agency considered that this process is working smoothly and that collaboration with DNAs 
in cases where the interpretation of the explicit consent is difficult is effective. The process 
has contributed, according to the Agency, to harmonised data and the reduction of clerical 
errors during the procedure.  

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. Eight Member 
States (compared to six in the previous reporting period) 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  21). The  number of  cases varies  greatly between 
Member States from four cases in Spain to 30 in Italy. In the previous reporting period, Italy 
had already the highest number of cases (49 in the period 2014-2016). 

23 Belgium indicated having implemented the explicit consent procedure pursuant to Article 14(6)(b) during the reporting 
period but did not provide figures.  

48 

 
 
 
 
 
 
 
 
 
 
                                                 
Table 21:  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 
Belgium 
Finland 
France 
Germany 
Italy 
Netherlands 
Spain 
United Kingdom 

2017 
2 
2 
4 
0 
13 
2 
0 
1 

2018 
1 
4 
2 
1 
8 
1 
0 
0 

2019 
12 
0 
2 
1 
9 
12 
4 
5 

Total  
15 
6 
8 
2 
30 
15 
4 
6 

One Member State reported difficulties in taking this decision, explaining that companies 
often  do  not  give  information  on  the  legislation  and/or  database  belonging  to  the  OECD 
country, which is important for the exporter's DNA in its verification activity. 

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. Thirteen Member States (compared to 11 in the previous reporting period) 
received waiver requests in accordance with Article 14(7) during the reporting period (see 
Table 22). The number of waiver requests received by DNAs varies greatly between Member 
States, from one request in Hungary to 148 in Belgium.  

Table 22: Number of waiver requests received per Member State during the reporting period 

Member State 
Belgium 
Finland  
France  
Germany 
Hungary  
Italy 
Lithuania 
Netherlands 
Poland  
Slovenia 
Spain  
Sweden 
United Kingdom 

2017 
31 
5 
47 
40 
0 
3 
0 
20 
0 
0 
10 
8 
21 

2018 
24 
5 
23 
33 
1 
3 
2 
16 
1 
0 
16 
2 
9 

2019 
93 
4 
59 
56 
0 
5 
0 
34 
5 
9 
13 
4 
13 

Total  
148 
14 
129 
129 
1 
11 
2 
70 
6 
9 
39 
14 
43 

Four  Member  States  stated  that  they  experienced  difficulties  in  implementing  the  waiver 
procedure. One of these DNAs reported difficulties with documents submitted in non-EU 
language for which translations had to be requested. Another DNA reported difficulties to 
verify whether Article 14.7 is fulfilled based on the information provided.  

The Commission generally considered that the waiver procedure worked smoothly during 
the reporting period, and that collaboration with the DNAs was positive.  The Agency has 
noted a decrease in the recurrence of some issues such as missing translations or incorrect 

49 

 
 
 
 
 
 
 
 
 
validity  dates.  However,  the  Agency  sometimes  had  exchanges  with  the  Commission, 
leading to the revision of the decision. The Agency has published in 2017 guidelines (“In 
brief” document) to assist exporting companies in proposing waivers through ePIC, which 
has, according to the Agency, also led to a reduction in the number of problematic cases and 
needs for revisions / resubmissions / rejections. One DNA confirmed it explaining that their 
handling of waivers has improved since the publication of the guidelines.  
As mentioned previously, the Agency considers that it would simplify the procedure and 
improve the overall efficiency of the waivers process, if it played an earlier and/or enhanced 
role in the waiver approval workflow. 

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. 

Fifteen Member States experienced cases where the export was allowed to proceed pending 
a reply to a new request for explicit consent (see Table 23). The highest number was reported 
by France, with 193 cases in total. 

Table 23:  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 
Croatia 
Czech Republic 
Finland 
France 
Germany 
Hungary 
Italy  
Netherlands 
Poland  
Slovakia 
Spain 
Sweden 
United Kingdom 

2017 
2 
17 
4 
1 
4 
52 
82 
1 
3 
14 
0 
0 
32 
9 
26 

2018 
0 
17 
0 
1 
4 
97 
50 
2 
4 
23 
2 
1 
24 
8 
18 

2019 
1 
8 
0 
0 
2 
44 
31 
1 
2 
8 
1 
0 
3 
14 
8 

Total  
3 
42 
4 
2 
10 
193 
163 
4 
9 
45 
3 
1 
59 
31 
52 

According  to  the  Agency,  Article  14(8)  remained  challenging  to  implement  during  this 
reporting period. However, the number of problem cases (i.e. in which the Agency and the 
DNAs disagree on the interpretation) has been substantially reduced after it was discussed 
at DNA meeting level in the previous reporting period (April 2015) and the related ePIC 
functionality was enhanced accordingly. 

4.8  Information on transit movement (Article 16) 

None of the Member States implemented Article 16 during the reporting period (as in the 
previous reporting period 2014-2016). 

50 

 
 
 
 
 
 
 
 
 
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. Only few Member States reported compliance issues; these mainly related 
to packaging requirements under the CLP Regulation and the SDS.  

Compliance issues relating to packaging and labelling requirements  

The  national  enforcement  authorities  in  six  Member  States  (compared  to  eight  in  the 
previous  reporting  exercise)  experienced  compliance  issues  concerning  the  information 
accompanying exported chemicals. Five of these six Member States indicated that they had 
identified compliance issues relating to the packaging requirements of the CLP Regulation. 
None of the six Member States reported compliance issues related to packaging requirements 
linked to the PPPR or the BPR (while in the previous reporting exercise three Member States 
reported issues linked to the BPR and two to the PPPR).  

Compliance issues with the SDS and the language(s) of the label or SDS  

Five 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, on the label (three Member States) 
and on the SDS (two Member States). 

Finally,  three  Member  States  reported  experiencing  compliance  issues  regarding  the 
information and packaging requirements linked to the exported products. Two indicated that 
these compliance issues were related to the expiry date, one to the storage conditions on the 
label,  one  to  export  or  import  bans,  and  one  indicated  that  these  compliance  issues  were 
related  to  language  (i.e.  the  information  on  the  label  is  not  given  in  the  language  of  the 
country of destination). 

4.10 Enforcement of the PIC Regulation (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 

51 

 
 
 
 
 
 
 
 
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). Seventeen Member 
States  have  put  in  place  an  enforcement  strategy  (including  rules  of  procedures,  written 
instructions,  etc.),  and  over  half  have  established  regular  training  of  inspectors.  Sixteen 
Member States reported having carried out controls on exports and 12 on imports during the 
reporting  period.  As  in  the  previous  reporting  period,  few  infringements  were  detected. 
Finally, DNA feedback on the Forum activities was positive.  

4.10.1  National enforcement authorities (NEAs) 

Most Member States have several authorities in charge of enforcing the PIC Regulation. As 
in the previous reporting exercise, customs are involved in the implementation of the PIC 
Regulation in all Member States except Malta and the United Kingdom. In six countries, the 
customs administration is the only NEA (Czechia, Italy, Latvia, Poland, Slovakia and Spain). 
In  the  previous  reporting  period,  it  was  the  case  only  in  four  Member  States24.  Other 
enforcement  authorities  are  typically  environmental,  chemical  and/or  health  inspection 
services. In eleven Member States, the NEA is part of the same institution as the DNA.  

In  almost  all  the  Member  States,  authorities  involved  in  the  enforcement  of  the  PIC 
Regulation  are  also  typically  involved  in  the  enforcement  of  the  CLP  Regulation  (25 
Member  States),  the  REACH  Regulation  (25  Member  States),  and  the  BPR  (21  Member 
States). 

Fifteen  Member  States  (compared  to  18  in  the  previous  reporting  period)  indicated  that 
NEAs  have  sufficient  resources  to  carry  out  their  obligations  under  the  PIC  Regulation, 
while eight  (compared to  seven in  the previous reporting period) stated they do not  have 
appropriate resources. Among those eight Member States, four had already stated in 2014-
2016 that they lacked resources, and three had stated  on the contrary  that  their resources 
were appropriate in the previous reporting period. Three Member States that had stated in 
2014-2016 that they did not have appropriate resources stated in this reporting period that 
they  do.  Where  Member  States  pointed  to  insufficient  resources  in  NEAs,  they  referred 
specifically to the lack of human resources (inspectors or customs officers), in particular for 
doing physical checks.  

4.10.2  Training inspectors  

Sixteen  Member  States  (compared  to  15  in  the  previous  reporting  period)  indicated  that 
inspectors are regularly trained on the PIC Regulation. Three Member States that had stated 
in 2014-2016 that inspectors were not regularly trained replied that they have been trained 
regularly during this reporting period.  

24 Croatia, Italy, Slovakia and Spain.  

52 

 
 
 
 
 
 
 
                                                 
Among the Member States that have organised regular training, twelve mentioned training 
activities  addressed  to  inspectors,  and  four  mentioned  training  activities  addressed  to 
customs’  officers.  Six  stated  that  such  training  is  included  as  part  of  general  training  on 
chemicals  legislation.  DNAs  mentioned  various  types  of  activities,  including  meetings, 
training from Forum pilot project, etc.  

Most  Member  States  that  have  not  organised  regular  training  on  the  PIC  Regulation 
explained  either  that  training  was  done  on  a  more  ad-hoc  basis  (meetings,  internal 
exchanges) or that PIC training had been provided initially in the previous reporting period 
but was not renewed in this reporting period because no specific need arose (e.g. staff has 
not changed).  

4.10.3  Enforcement strategy  

Seventeen Member States (compared to 16 in the previous reporting period) reported having 
a strategy for the enforcement of the PIC Regulation, out of which 16 have already fully 
implemented that strategy, and one has implemented it partially (Figure 17). Three Member 
States that did not have a strategy in the previous reporting period have stated that they had 
one during this reporting period (Denmark, Greece and Malta). Two Member States that had 
reported  having  a  strategy  in  the  period  2014-2016,  indicated  not  having  one  during  this 
reporting period (Italy and Lithuania). 

Figure 17:  Question  62.  Does  your  authority  (or  any  other  relevant  authority)  have  an  enforcement 

strategy for Regulation (EU) No 649/2012?  

11, HR, EE, FI, FR, IT, 
LV, LT, LU, SI, ES, SE

17, AT, BE, BG, CY, CZ, 
DK, DE, EL, HU, IE, MT, 
NL, PL, PT, RO, SK, UK

Yes No

4.10.4  Enforcement activities  

During the reporting period, documentary checks were carried out in around two thirds of 
the Member States (19), while less than half reported carrying out proactive inspections or 
on site checks (Figure 18).  

53 

 
 
 
 
 
 
 
 
 
Figure 18: Enforcement activities carried out in Member States25  

Documentary checks

19

Investigations/reactive inspections i.e. of issues 
brought to the enforcement authority’s attention

Proactive/routine inspections

On-site checks

Announced inspections

Unannounced inspections

Sampling

Others

14

13

12

11

8

7

7

0

2

4

6

8

10

12

14

16

18

20

Number of Member States

Four Member States mentioned other enforcement activities:  

  Forum PIC pilot project in 2018; 
  Custom checks of customs declaration, RIN or special RIN, consistency of annexed 
documents, labelling requirements, provision of Safety Data Sheet, where relevant 
of import decision  

  Customs’ physical inspections of goods  

Ten Member States (compared to 13 in the previous reporting period), reported that customs 
authorities  performed  controls  related  to  the  PIC  Regulation  during  the  reporting  period, 
representing  the  largest  number  of  controls  in  those  countries.  Eleven  Member  States 
reported controls performed by NEAs. Table 24 presents the data reported by DNAs.  

In four Member States, customs carried out controls on imports during the reporting period. 
NEAs reported performing controls on imports in ten Member States. DNAs reported the 
data contained in Table 25.  

Table 24:  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 
Austria26 
Belgium 
Bulgaria 
Croatia 
Cyprus 
Czech Republic 
Denmark27 
Estonia 

Customs 
N/A 
2 402 
69 
N/A 
Ν/Α 
N/A 
N/A 
0 

Inspectors  
N/A 
69 
4 
N/A 
Ν/Α 
N/A 
11 
0 

Others  
N/A 
0 
0 
N/A 
0 
N/A 
N/A 
0 

25 Latvia ticked ‘other’, indicating that no enforcement activities were carried out (as no exports took place during the 
reporting period). 
26 Austria indicated that customs authorities control all exports of chemicals, also with a view to compliance with the PIC 
Regulations, but there are no statistics on controls.  
27 50 control on exports have been performed during the PIC Pilot project in 2018.  

54 

 
 
 
 
 
 
 
 
                                                 
Member State 
Finland 
France 
Germany 
Greece 
Hungary 
Ireland 
Italy 
Latvia 
Lithuania 
Luxembourg 
Malta 
Netherlands 
Poland29 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 
United Kingdom 

Customs 
4 442 
68 
N/A 
0 
375 
0 
399 
0 
0 
0 
N/A 
354 
N/A 
129 
N/A 
0 
35230 
9 
0 
0 

Inspectors  
0 
1 
91 
5428 
104 
0 
N/A 
0 
0 
0 
0 
178 
N/A 
0 
6 
1 
0 
0 
7 
0 

Others  
N/A 
0 
N/A 
0 
0 
0 
N/A 
N/A 
0 
0 
N/A 
0 
N/A 
0 
6 
1 
0 
0 
N/A 
0 

Table 25:  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 
France 
Germany 
Greece 
Hungary 
Ireland 
Italy 
Latvia 
Lithuania 
Luxembourg 
Malta 
Netherlands 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 
United Kingdom 

Customs 
N/A 
0 
4 
N/A 
Ν/Α 
N/A 
N/A 
0 
N/A 
0 
N/A 
0 
0 
0 
183 
0 
0 
0 
N/A 
0 
N/A 
49 
N/A 
0 
0 
1 
N/A 
0 

Inspectors  
N/A 
1 
17 
N/A 
Ν/Α 
N/A 
N/A 
0 
0 
0 
10 
0 
54 
645 
N/A 
0 
0 
2 
0 
365 
N/A 
34 
64 
0 
0 
0 
0 
1 

Others 
N/A 
0 
0 
N/A 
0 
N/A 
N/A 
0 
N/A 
0 
0 
0 
0 
0 
N/A 
N/A 
0 
0 
N/A 
0 
N/A 
0 
33 
0 
0 
0 
N/A 
0 

28 Controls carried out during the PIC pilot project.  
29  No  information  available  from  the  Tax  Administration  Chamber  on  controls  related  the  enforcement  of  the  PIC 
Regulation. 
30 Including 58 physical controls of goods, other documentary controls.  

55 

 
 
 
                                                 
As part of its report, the Agency provided estimates of the use of the ePIC customs interface 
by DNAs. As the customs interface is used by customs authorities for control purposes, data 
provided by DNAs can be checked against the data provided by ECHA (although it should 
be  noted  that  only  23  Member  States  consulted  the  application).  Based  on  the  numbers 
provided by the Agency, on average 5 500 customs controls have been carried out through 
the ePIC customs interface. More specifically:  

  One Member State checked > 2 200 individual notifications. 
  One Member State checked ~850 individual notifications. 
  Four Member States checked between 200 - 600 individual notifications. 
  Four Member States checked between 100 - 200 individual notifications. 
  Ten Member States checked between 10 - 50 individual notifications. 
  Three Member States checked < 10 individual notifications. 

4.10.5  Powers of enforcement authorities  

Member States were asked to describe the measures that enforcement authorities can take to 
ensure  compliance  with  the  PIC  Regulation  (Figure  19).  In  about  three  quarters  of  the 
Member  States  (22),  administrative  measures  /  orders  and  written  advice  can  be  used  by 
enforcement authorities to ensure compliance with the PIC Regulation. Slightly over half of 
the  Member  States  indicated  they  can  use  verbal  advice  and  about  a  third  can  seize, 
confiscate or destroy non-compliant products.  

Figure 19:  Measures that can be taken by enforcement authorities to ensure compliance with the PIC 

Regulation 

Administrative measures/orders

Written advice

22

22

Verbal advice

16

Seizure or confiscation or destruction of non-
compliant products

Other

0

11

9

5

10

15

20

25

Number of Member States

Other measures mentioned by Member States include:  

  Formal letter, Improvement Notice, Enforcement Notice; 
  Banning the operator from continuing operations or repeating procedures in violation 

of the provisions; 

  Suspension of the release of goods on the market; 
  Refusal of application of the requested customs procedure (import/export); 
  Withdrawal of goods from the market / EU customs territory; 
  Notification to EU Member States who are responsible for PIC export. 

56 

 
 
 
 
 
 
 
 
4.10.6   Infringements during the reporting period  

Infringements found through customs controls  

Five Member States (compared to three in the previous reporting period) reported identifying 
infringements  through  customs  controls  (Belgium,  France,  Netherlands,  Portugal,  and 
Spain) (see Table 26). The number of infringements is very low compared to the number of 
customs controls performed.  

Table 26: Number of customs controls and infringements observed during the reporting period  

Member State 
Belgium 
France  
Netherlands 
Portugal  
Spain 

Controls on exports 
2 402 
68 
354 
129 
9 

Controls on imports 
0 
0 
0 
49 
1 

Infringements found 
23 
7 
2 
1 
1 

Infringements found through inspectors’ controls  

Six Member States (compared to nine in the previous reporting period) found infringements 
through controls carried out by inspectors (Table 27). 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. The number of infringements compared to the number of 
controls varies greatly across the six Member States, but is generally higher compared to the 
ratio shown above for customs controls. 

Table 27:  Numbers  of  controls  carried  out  by  inspectors  and  infringements  observed  during  the 

reporting period  

Member State 
Belgium 
Bulgaria 
Denmark 
Germany 
Hungary 
Netherlands 

Controls on exports 
69 
4 
11 
91 
104 
178 

Controls on imports 
1 
17 
N/A 
10 
54 
365 

Infringements found 
29 
6 
3 
52 
12 
2 

Infringements found through other controls  

Only  one  Member  State  (the  Netherlands)  reported  infringements  found  in  controls 
performed by other authorities (two infringements in total for the reporting period).  

As shown in Table 28, the main category of infringement found by customs related to the 
absence of RIN (13 infringements) and Box 44 of the single administrative document not 
being properly filled (12 infringements).  

As shown in Table 29, the main category of infringement found by inspectors related to the 
absence of export notification for the chemical (25 infringements) and Safety Data Sheets 
provisions (18 infringements).  

57 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 28: Types of infringements of the PIC Regulation observed by customs during the reporting period 

Type of infringement 
No  export  notification  provided  for  the 
chemical 
No RIN provided (Article 8) 
RIN not valid during export period (Article 
8) 
Box  44  of 
document not properly filled 
Other  

the  single  administrative 

Belgium 
N/A 

10 
1 

12 

1 
3 

0 

N/A 

331 

France   Netherlands  Portugal  Spain 
0 

0 

0 

1 

1 
1 

0 

0 

1 
0 

0 

0 

0 
0 

0 

1 

Table 29:  Types of infringements of the PIC Regulation observed by inspectors during the reporting 

period 

Type of infringement 
No export notification provided for the 
chemical 
Chemical not in conformity with export 
notification 
No RIN provided (Article 8) 
RIN  not  valid  during  export  period 
(Article 8) 
Box  44  of  the  single  administrative 
document not properly filled 
Expiry date of the chemical 
Labelling provisions (Article 17(1)) 
Safety  Data  Sheets  provisions  (Article 
17(3)) 
Language provisions (Article 17(4)) 
Other 

Belgium 
19 

Bulgaria 
0 

N/A 

0 
9 

N/A 

N/A 
N/A 
1 

N/A 
N/A 

0 

0 
0 

0 

0 
0 
6 

0 
0 

Denmark  Germany  Hungary 
1 

5 

0 

0 

1 
0 

0 

0 
0 
0 

0 
0 

7 

4 
4 

13 

1 
2 
5 

1 
432 

0 

1 
0 

0 

0 
3 
6 

0 
333 

4.10.7  Penalties  

In  almost  all  Member  States  (26),  administrative  or  criminal  fines  are  applied  in  case  of 
infringement of the PIC Regulation and 12 Member States have the possibility to issue prison 
sentences (Figure 20). This is higher than in the previous reporting period where 23 Member 
States  had indicated that they  could  impose fines for specific infringements,  often with  a 
scale of fines depending on the gravity of the infringement, and seven Member States had 
indicated  that  a  penalty  of  imprisonment  could  be  imposed  on  the  most  serious 
infringements. 

Twenty-nine  infringements  in  three  Member  States  led  to  penalties  (compared  to  13 
infringements in four Member States in the previous reporting period) (see Table 30).  

31 Exports falsely declared as different goods; undeclared exportation.  
32 One infringement against the Product Safety Law, two against the duties of article 10 PIC Regulation (annual export 
amounts have not been named).  
33 Annual reporting provisions (Article 10).  

58 

 
 
 
 
 
 
 
 
 
                                                 
Figure 20: Penalties applied in case of infringement of the PIC Regulation 

Criminal/administrative fines

26

Prison sentence

12

Suspension or revocation of business license

Other sanctions

5

5

0

5

10

15

20

25

30

Number of Member States

Table 30: Number of infringements that led to penalties during the reporting period  

Member State 

Belgium 
Denmark 
Germany  

Number 
found 
52 
3 
52 

of 

infringements 

Number of infringements that 
led to penalties 
18 
1 
10 

4.10.8   Collaboration between DNAs and NEAs  

Collaboration between DNAs and NEAs  

Twenty-five Member States (compared to 23 in the previous reporting period) indicated that 
there is a regular exchange of information between the DNA(s) and enforcement authorities. 
Seven  Member  States  stated  that,  as  the  DNA  and  the  NEA  are  in  the  same  institution, 
information sharing occurs easily, whenever necessary. Five Member States indicated that 
regular meetings were held between DNAs and NEAs to exchange information, while six 
mentioned regular exchanges of information through email to contact points, or following 
procedures provided for in laws, agreements or guidelines. Four mentioned regular exchange 
and/or meetings with customs authorities. 

Five  Member  States  made  suggestions  to  improve  collaboration  between  the  DNAs  and 
enforcement authorities at national level:  

  Enhancing  information  exchange,  organising  seminars  and/or  training  (three 
Member  States)  Regular  notification  of  innovations  to  customs  by  the  DNA  (one 
Member State). 
 
Integrating better custom activities with local enforcement (one Member State). 
  Setting up a training system involving both DNA and customs staff (one Member 

State). 

  Ensuring regular exchanges of data between DNA and customs to facilitate the risk-

based control of hazardous chemicals (one Member State). 

  Setting up a network of liaison  officers, including the relevant  DNA and customs 

staff (one Member State). 

59 

 
 
 
 
 
 
 
 
 
 
Other comments related to actions to be taken at EU level:  

  More frequent uptake of PIC in FORUM activities, e.g. on labelling requirements for 

 

all dangerous chemicals (CLP) (one Member State). 
Invite Forum members involved in the PIC pilot project carried out in 2018 or any 
other project related to PIC DNA meetings (one Member State). 

Collaboration  between  DNAs  and  national  members  of  the  Forum  for  Exchange  of 
Information on Enforcement  

Twenty-three Member States (as in the previous reporting period) indicated that there is a 
regular  exchange  of  information  between  the  DNAs  and  the  national  member(s)  of  the 
Forum.  

Among these Member States, 11 explained that since the Forum member is also a member 
of the DNA, or is part of the same institution, regular exchanges of information occur without 
formal communication/coordination mechanisms. Other Member States indicated that there 
are  regular  exchanges  of  information,  either  through  written/electronic  communication 
channels or through regular meetings between institutions on outcomes of DNA meetings, 
outcomes of Forum meetings, and Forum's activities related to PIC. 

Nearly  all  DNAs  stated  (26)  that  they  were  satisfied  with  the  collaboration  with  Forum 
members. Three Member States provided suggestions for improving collaboration between 
DNAs and Forum members:  

  Regular report from the Forum secretariat at the DNA meetings should continue (one 

Member State). 

  Organisation of meetings between the Forum and the DNAs to discuss enforcement 
issues  and  identify  potential  enforcement  projects  (Belgium)  and  strengthen 
communication between the two (one Member State).  

4.10.9   Forum activities  

Unlike in the previous reporting period, there has been a regular exchange of information 
within the Forum on the coordination of enforcement of the PIC Regulation.  PIC related 
discussions in Forum focused on:  

  A pilot project on the control of PIC and a resulting guide for inspectors;  
  The  support  to  Commission  in  developing  a  PIC-related  form  for  the  ICSMS 
(‘internet-supported information and communication  system for the pan-European 
market surveillance’);  

  Discussions  on  the  applicability  of  the  PIC  Article  8  notification  duty  to  PIC 

substances exported as impurities of other substances;  

  The  review  of  the  PIC  Article  22(1)  template  for  the  Member  State  report  to  the 

Commission.  

During 2017-2018, the Forum prepared and conducted a pilot project on the control of PIC 
focusing  on  export  notifications  (Articles  8,  14,  and  15)  and  information  to  accompany 
exported chemicals (Article 17), to which thirteen Member states participated. A total of 296 
inspections  were  completed  by  Member  States,  consisting  of  both  on-site  and  desktop 
inspections34.  One of the recommendations drawn from  the project  was  for the Forum to 
include  the  enforcement  of  PIC  obligations  in  future  projects.  In  2019,  following  the 
completion of the project, the Forum prepared a ‘Practical enforcement guide for the control 

34 ECHA (2018) Final report of the Forum pilot project on the control of PIC.  

60 

 
 
 
 
 
 
                                                 
of PIC obligations’ describing good practices in the enforcement of PIC Articles 8, 14, 15 
and 17, as developed during the pilot project. 

The Forum recommended to run another project in the future. According to the Agency, an 
improvement would be to include PIC duties in an integrated enforcement project covering 
also other pieces of legislation and involving close cooperation with the customs authorities. 

Member  States  were  generally  satisfied  with  the  activities  carried  out  by  the  Forum  (20 
Member States – compared to 19 in the previous reporting exercise – indicated they were 
satisfied with Forum activities).  

Seven  Member  States  made  suggestions  for  improving  the  activities  of  the  Forum 
concerning the PIC Regulation:  

  Four  Member  States  underlined  the  benefits  of  pilot  projects  such  as  the  one 
conducted in 2018, and three suggested that the Forum could organise similar pilot 
projects in the future. One Member State suggested that a new PIC enforcement pilot 
project  could  aim  to  strengthen  the  cooperation  between  customs  authorities  and 
other  enforcement  authorities  (responsible  for  REACH/CLP/biocide)  to  increase 
consistency in the interpretation of the legal requirements. On the same issue, one 
Member State mentioned that the DNA group should more proactively engage with 
the work of the Forum in relation to PIC. For instance, DNAs could consider whether 
they would like to collaborate on practical issues for enforcement and harmonised 
enforcement projects, which could be communicated to the Forum for consideration.  
  One Member State indicated that exchanges of good practices across Member States 

could be increased.  

The  Forum  considered  in  its  work  programme  2019-2023  that  inspections  of  PIC  duties 
should become part of the NEAs’ enforcement routine. However, according to the Agency, 
due to the limited resources and many other priority areas for coordinated enforcement by 
the Forum, careful prioritisation of PIC activities is essential. 

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 
toxicological, 
ecotoxicological and safety information. Every two years, the Agency must compile all of 
the relevant information that has been transmitted. 

the  PIC  Regulation, 

including 

to 

Information provided following ad-hoc requests  

As mentioned in the previous report, the Commission replied to four requests in the period 
2016-2017  from  four  countries  (Canada,  Indonesia,  Lebanon  and  Syrian  Arab  Republic) 
concerning four chemicals35. During the period 2018-2019, the Commission did not receive 
any ad-hoc requests falling within the scope of Article 20 of the PIC Regulation36. 

35 ECHA, Overview on the exchange of information under Article 20 of the PIC Regulation 2016-2017. Compilation of the 
information collected by the European Commission, assisted by the Member States and the European Chemicals Agency, 
ECHA-2018-R-20-EN, November 2018: 
https://echa.europa.eu/documents/10162/21728206/pic_article_20_report_2016-2017_en.pdf/f305378c-713c-bcd7-f2d7-
03ac2400e679  
36  ECHA,  Report  on  the  exchange  of  information  under  the  PIC  Regulation  in  years  2018-2019.  Compilation  of  the 
information transmitted by the European Commission, the Member States and the European Chemicals  Agency, under 
Article 20 of the PIC Regulation, ECHA-20-R-15-EN, 2020:  

61 

 
 
 
 
 
 
 
                                                 
In 2018 and 2019, the Agency received nine requests falling within the scope of Article 20, 
from  national  authorities  in  seven  non-EU  countries,  namely  Benin,  Bosnia  and 
Herzegovina,  Iraq,  Jordan,  Lebanon,  Sri  Lanka  (3  initial/follow-up  requests  in  total)  and 
Turkey and from one international organisation, the United Nations Industrial Development 
Organisation (UNIDO). Those requests related to the following topics37:  

  Question  related  to  the  scientific  and  regulatory  background  for  the  banning  of 

diphenylamine in pesticide products (Iraq).  

  Question  related  to  the  scope  of  the  REACH  Restriction  on  ethylene  dichloride 

(Turkey). 

  Question  related  to  the  regulatory  status  of  the  use  of  nonylphenol  ethoxylates  in 

plant protection products (Lebanon).  

  Question  related  to  the  scope  of  the  REACH  Restriction  on  nonylphenol  / 

nonylphenol ethoxylates (Jordan).  

  Question  related  the  listing  of  three  substances  under  the  PIC  Regulation 

(endosulfan, alachlor, aldicarb) (Bosnia and Herzegovina).  

  Question  related  to  the  regulatory  status  of  exports  of  HBCD-based  products 

(UNIDO). 

  Questions related to the functioning of the PIC Regulation, as well as requests for 

further information on specific chemicals (Sri Lanka).  

  Question related to the regulatory status of chloroform within the EU (Benin).  
  Question related to the regulatory status of diphenylamine within the EU (Benin). 

The Member States did not receive any ad-hoc requests for information during the reporting 
period38.  

Reporting on the information transmitted 

The  Agency  publishes  every  two  years  summaries  of  information  provided  by  the 
Commission, DNAs and the Agency to authorities in non-EU countries. The reports address 
information submitted by means of export notifications, FRA notifications, and following 
ad-hoc  requests.  The  report  covering  the  period  2016-2017  was  published  in  November 
201839 and the second report, covering the period 2018-2019 was published in 202040.  

The  Agency  did  not  experience  difficulties  in  collecting  the  information  from  the 
Commission and the Member States on the data transmitted, nor in compiling the report in 
accordance with Article 20(4) of the PIC Regulation.  

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 

https://echa.europa.eu/documents/10162/21728206/pic_article_20_report_2018-2019_en.pdf/f3ed3740-bd90-c7da-cebe-
0e4a6a77ef2c  
37 Idem.  
38 Idem 
39 ECHA, Overview on the exchange of information under Article 20 of the PIC Regulation 2016-2017. Compilation of the 
information collected by the European Commission, assisted by the Member States and the European Chemicals Agency, 
ECHA-2018-R-20-EN, November 2018.  
40  ECHA,  Report  on  the  exchange  of  information  under  the  PIC  Regulation  in  years  2018-2019.  Compilation  of  the 
information transmitted by the European Commission, the Member States and the European Chemicals  Agency, under 
Article 20 of the PIC Regulation, ECHA-20-R-15-EN, 2020.  

62 

 
 
 
 
 
 
                                                 
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 and DNAs participated in activities intended to promote a better understanding and 
implementation of the provisions of the PIC Regulation and a better implementation of the 
Rotterdam Convention. 

Cooperation with developing countries, countries with economies in transition and NGOs  
During  the  reporting  period,  the  Agency  was  involved  in  the  following  cooperation 
activities:  

  May  2017  and  May  2019:  in  parallel  to  the  Conference  of  Parties,  the  Agency 
contributed to technical meetings between the EU and groups of non-EU Parties, to 
which  participated  in  total  40  to  50  delegates  from  non-EU  Parties  and  some 
delegates from Member States. The objectives of these meetings were to clarify the 
specific provisions of the EU PIC Regulation that deviate from the Convention, to 
discuss specific export cases and to gather feedback from the authorities of the non-
EU Parties. These meetings were followed by one-to-one discussions between the 
Agency and several non-EU country authorities.  

  September  2018  –  ECHA  attended  a  side-event  to  the  Basel  Convention’s  11th 
meeting of the Open-Ended Working Group on the implementation of the Bamako 
Convention on the ban on the Import of hazardous waste into Africa and the Control 
of Transboundary Movement and Management of Hazardous Wastes within Africa, 
organised by the French DNA. 

  June  2019  –  ECHA  participated  in  the  workshop  organised  by  the  Rotterdam 
Convention Secretariat on training and fostering collaboration between DNAs on the 
implementation  of  the  Rotterdam  Convention  in  the  Maghreb  countries:  Algeria, 
Morocco and Tunisia. The objective of the workshop was to provide training on the 
key obligations under the Rotterdam Convention, to revise the implementation of the 
national  action  plan  for  complying  with  the  Convention  in  each  country  and  to 
facilitate chemicals trade between the EU and the Maghreb countries by promoting 
a better understanding of the EU PIC Regulation.  

  September  2019  –  ECHA  provided  support  to  the  European  Commission  in  the 
preparations for a regional training workshop to strengthen the capacity of countries 
in the African region to implement the Basel and Rotterdam Conventions, in Dakar, 
Senegal.  

Five  Member  States  participated  in  cooperation  activities,  as  in  the  previous  reporting 
exercise, although the five Member States are different (AT, BE, BG, FR, DE)41. Activities 
mostly related to the provision of technical information, the support for the establishment or 
maintenance  of  DNAs  and  other  areas.  None  of  the  Member  States  were  involved  in 
cooperation  regarding  technical  expertise  for  the  preparation  of  notifications  to  the 
Secretariat and promotion of the exchange of experts, in which several Member States had 
been involved in the previous reporting exercise (Figure 21).  

41 BE, BG, DE, SI, and SE were involved in the period 2014-2016.  

63 

 
 
 
 
                                                 
Figure 21: Question 56. What types of cooperation have you been involved in? 

Other

3, BE, FR, DE

Technical information

2, BG, DE

Support for the establishment or maintenance of
DNAs

1, BG

Promotion of the exchange of experts

Technical expertise for the identification of
hazardous pesticides formulations
Technical expertise for the preparation of
notifications to the Secretariat

0

0

0

0

1

2

3

4

Number of Member States

Three DNAs mentioned other types of cooperation:  

  Participation  in  a  subregional  workshop  organised  by  the  Secretariat  to  foster 
collaboration between DNAs on the implementation of the Rotterdam Convention 
(Rabat, 24-26 June 2019) (Belgium).  

  Organisation of side event with African states Parties at the Bamako Convention in 
September 2018 followed by the organisation of a capacity building workshop for 
African countries in Dakar in 16-19 September 2019 (France).  

  Visits of expert delegation to the Member States’ institutions (visit of an IPA expert 
delegation to the Federal Institute for Operational Safety and Health in Dortmund) 
(Germany).  

Capacity-building activities  

The Agency has provided throughout the reporting period training and support to pre- and 
candidate  countries  to  increase  capacity  in  the  area  of  chemical  management  via  the  EU 
Instrument  for  Pre-accession  assistance  (IPA).  These  activities  included  support  to 
beneficiaries’ efforts in  aligning their national regulation  for the provisions to implement 
Rotterdam Convention, with those in the EU. In addition, the Agency has been involved in 
non PIC-specific activities – but which may cover the PIC Regulation – such as providing 
speakers for events outside the EU or addressing requests for visits from third countries to 
learn about REACH, ECHA databases, and for potential cooperation.  

Four  Member  States  (compared  to  six  in  the  previous  reporting  exercise)  participated  in 
projects  or  international  activities  relating  to  capacity-building  in  chemicals  management 
during the reporting period:  

  Organisation of side event with African states Parties at the Bamako Convention in 

September 2018 (France).  

  Visits of expert delegation to the Member States’ institutions (visit of an IPA expert 
delegation to the Federal Institute for Operational Safety and Health in Dortmund) 
(Germany). 

  Co-financing of a study related to POPs (Netherlands). 
 

International  Training Program  in  Chemicals  Management (ITP) with  participants 
from developing countries twice a year (Sweden).  

  Cooperation  projects  to  support  countries  in  capacity  building  in  chemicals 
management (Serbia, Albania, South Africa, Zambia, Vietnam etc.) (Sweden). 

64 

 
 
 
 
 
 
 
 
4.13 IT-related aspects 

Under the PIC Regulation, 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 the PIC Regulation 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, DNAs find ePIC user-friendly and reported no major issues in using it. Answers to 
the  questionnaire  show  that  DNAs’  opinion  on  ePIC  has  improved  since  the  previous 
reporting period and that more DNAs have experience with ePIC. 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 and some have been prioritised for implementation in the next 
reporting period, such as the integration of Article 10 non-confidential report generation in 
ePIC and improving the internal and external messaging system. All of the data that should 
have  been  made  publicly  available  by  the  Agency  according  to  the  Regulation  are  made 
available online.  

4.13.1  The ePIC system  

The number of ePIC users from industry, DNAs and NEAs has increased since the previous 
reporting period (see Table 31).  

Table 31: Number of ePIC users during the reporting period42  

Number of users 
Industry  
DNAs  
Commission 
NEAs 

2017-2019 
2 398 
137 
1 
445 

2014-2016 
1 836 
127 
1  
388 

The following new features were added to the ePIC system during the reporting period:  

  Adaptations required in relation to BREXIT43:  

o  Enabling submission of standard export notifications and special RIN requests for 

exports from EU-27 companies to the United Kingdom (UK).  

o  Enabling registration of import notifications from the UK.  
o  Maintenance of explicit consents requested by the UK.  

42 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.  

43 The feature was not yet visible in ePIC during the reporting period and at the time the Agency submitted its report as it 
required a date of application of Brexit (i.e. after the end of the transition period) to be encoded.  

65 

 
 
 
 
 
 
 
 
                                                 
o  Revocation of UK companies’ and authorities’ access rights.  
o  Adaptation of all searches.  
o  Disabling of UK export notifications. 

 

Improvements in Explicit Consent management: 
o  DNAs:  possibility  to  close  several  requests  by  one  response;  prevention  of 

creating requests for part 1 substances.  

o  ECHA: additional check on the terms and conditions of explicit consent responses 

(introduction of an internal Initiation-Validation cycle). 

  “DLQ” (Dead Letter Queue): addition of a back-office functionality for ECHA to 
detect  and  resume  “frozen”  submissions.  Enhancing  the  Agency’s  back-office 
functionality  was considered as  an  area of improvement in  the previous reporting 
period.  

 

 

Improvements in RIN match algorithms, to cover cases under Article 14(8), second 
paragraph  of  the  PIC  Regulation  (so  called  “12-months  extension  of  an  expired 
response”).  This  was  mentioned  in  the  previous  reporting  period  as  a  needed 
improvement.  

Improvements in PIC Annexes Amendments’ management, to better manage cases 
of a substance moving from Part 1 to Part 2/3 of the Annex I to the PIC Regulation. 
Improving the management of the chemicals database and simplifying the insertion 
of new amendments was considered in the previous reporting period as an area of 
improvement.  

  Declarations of the language of the SDS files in an export notification.  

 

Improvements in data validation, such as: 
o  Section  6.1  of  an  export  notification  filled-in  automatically  in  the  relevant 

language.  

o  Business  rules  implemented  to  ensure  fully  comprehensive  importer  details  in 

export notifications. 

Improving data validation checks was identified as an area of improvement in the previous 
reporting period.  

 

Improved searches:  
o  Search for substances that ECHA added to Annex I group entries after the group 

was originally introduced by an amendment.  

o  Search for chemicals by amendment, Annex part and CAS-number.  
o  Search for explicit consents by use category.  
o  Search for article 10 reports and import notifications by ID. 

Further  refining  search  options  to  facilitate  navigation  was  identified  as  an  area  of 
improvement in the previous reporting period.  

  Terms and conditions revised for all user groups. 

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 should also ensure that some of the identified issues are solved, that process 
efficiency keeps improving as well as the capacity to process an increasing number of tasks. 
However,  the  Agency  considered  that  the  rather  modest  available  budget  for  ePIC 
development has proven to be a limiting factor over the years. 

66 

 
 
 
 
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, 
such as the improvement of the management of explicit consents with the possibility to close 
several explicit consent requests with one response, the introduction of several new searches 
(e.g. search of explicit consents by CAS number, search of import notifications or Article 10 
reports  by  ePIC  identification  number)  or  a  warning  message  relating  to  the  maximum 
quantity  of  10  kg  to  be  exported  for  Special  RIN  requests  under  Article  2(3)  of  the  PIC 
Regulation.  

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. 
Comparison with results from the previous reporting show that DNAs’ opinion on ePIC has 
improved (more DNAs replied ‘yes’ in relation to all obligations) and that more DNAs have 
experience with ePIC than in the previous reporting (less DNAs have replied ‘no experience 
in relation to all obligations) (Figure 22).  

Figure 22: 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))

27

25

21

20

1

3

7

7

1

When dealing with reporting pursuant to Article 10

26

2

When dealing with other PIC procedures

18

10

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%100%

Number of Membre States

Yes

No

No experience

Exporters and importers  

As in the previous reporting period, the Agency received generally positive feedback from 
industry users, with stakeholder surveys indicating that 93% of industry users in 2017 and 
95% in 2018 were satisfied with Epic, in particular for the simplicity of the application. The 
Agency however collected some comments and suggestions for improvements during the 
reporting period:  

  The  possibility  for  direct  communication  with  ECHA  inside  the  ePIC  application 

would be welcomed;  

  Error messages are difficult to understand;  
  An “End-to-end system” to support automated submissions from companies’ internal  
  systems to ePIC directly should be considered 

67 

 
 
 
 
 
 
 
 
 
  Visibility of event history for explicit consent reminders should be added 
 

It is somehow difficult to find the reason for re-submission or rejection request. 

As in the previous reporting period, 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 question (Figure 23). Responses are relatively similar compared to the 
previous reporting. 

Figure 23:  Question  80.  Where  possible,  please  provide  feedback  from  exporters  on  the  user-

friendliness of the ePIC system.  

General user-friendliness

Export notifications

12

12

4

5

Special RIN requests

11

2

12

11

15

16

Waivers

Article 10 Reporting

Management of mixtures/articles via ePIC

9

9

3

13

2

13

4

15

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Number of Membre States

Easy to use

Not easy to use

No Answer

One Member State mentioned that companies which do not export on a regular basis forget 
the procedure for submission of the notifications/explicit consent requests to the DNAs or 
the  procedure  for  submitting  the  aggregated  annual  quantities.  Another  Member  States 
reported that exporters  who are not frequent  users find it difficult  to use e-PIC, and find 
information  or  guidance.  Two  Member  States  mentioned  language  issues  as  sometimes 
information or guidance is only available in English.  

One Member State stated that industry users should see same information in event history as 
DNAs. The Member State considered that ePIC is not transparent concerning the feedback 
of the importing countries in case of necessary explicit consent requests.  

One Member State also indicated that RINs were sometimes received very late in the year 
(e.g. 15 days before the end of the year), which is not sufficient for industry, planning of 
transports etc., three months would be needed. 

Member States also reported a number of suggestions for technical improvements:  
Export Notifications  

  The attachment of annexes (e.g. SDS) could be improved.  

Special RIN requests  

  A function ‘create duplicate (new)’ as for export notifications would be useful.  
  The distinction between cases when a SRIN is necessary or not could be improved 
(EU waiver like Switzerland/Brazil; positive Import Decisions in the PIC Circular).  

68 

 
 
 
 
 
 
 
 
 
 
 
Waivers  
 

Insufficient  clarity  on  what  kind  of  documents  can  be  provided  as  documentary 
evidence from an official source. 

Article 10 reporting  

  The  function  “sort  by  country  etc.”  could  be  improved;  the  waiting  time  when 
uploading is too long, and search by CAS number in the drop down menu is difficult.  

Management of mixtures/articles via ePIC 

  Confusion between templates (substance, mixture or article).  
  The fact that, in the Article 10 report, only the amount of PIC components is counted 

is misleading in comparison to transport documents and leads to mistakes. 

Customs authorities 

20 Member States reported that their customs authorities used ePIC, the majority of whom 
(15 Member States) stated their belief that customs found ePIC easy to use and an adequate 
tool to support them in controlling the application of the PIC Regulation (12 Member States).  

According to the Agency, some Member States have expressed the interest to link ePIC to 
their national customs applications, in order to automate controls of these exports. During 
the reporting period, initial contacts were initiated with the relevant European Commission 
services  regarding  the  feasibility  and  conditions  for  connecting  ePIC  to  a  centralised 
application for automated checks by the customs authorities (“Single Window” project). 

Other enforcement authorities  

Five  Member  States  replied  that,  to  their  knowledge,  other  enforcement  authorities  were 
using ePIC (against six in the previous reporting) and six that they were not (against ten in 
the previous reporting). These five Member States replied that these enforcement authorities 
consider ePIC easy to use and four replied, to their knowledge, other enforcement authorities 
considered ePIC adequate to support them in their enforcement work.  

The  Agency  received  no  specific  feedback  from  NEAs  during  the  reporting  period. 
However, according to the Agency, the interest expressed for the integration of PIC-related 
information into the “internet-supported information and communication system for the pan-
European  market  surveillance”  (which  was  finalized  in  2018)  can  be  interpreted  as  a 
recognition of the importance and relevance of the data contained in ePIC. 

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:  

 

Integration of Article 10 non-confidential report generation, i.e. to generate the non-
confidential Article 10 report in ePIC directly (and not outside of the application as 
it has been done so far). This item was already mentioned in the previous reporting 
period but has not been implemented in this reporting period. It has however been 
prioritised for implementation in the next reporting period.  

  Messaging: to improve/modify the internal and external messaging system in ePIC, 
for  enhanced  traceability  and  audit  purposes  in  particular.  Improving  internal 
messaging  was  already  mentioned in  the previous  reporting period. This  item  has 
been prioritised for implementation in the next reporting period.  

  Further improvement to the management of the chemicals database, in order to:  

o  make the chemicals more easily searchable;  

69 

 
 
 
 
 
 
o  change the way chemicals listed in Annex V part 2 are introduced in the database;  
o  facilitate data dissemination. 
o  This  item  was  already  mentioned  in  the  previous  reporting  period  and  some 
improvements have already been made in this reporting period (see 4.13.1).  
Increased  automation  to  reduce  manual  tasks  (e.g.  partial/full  (pre-)validation  of 
export notifications for Annex I, Part 1 substances, recording of acknowledgement 
of receipts), to enable further resources/efficiency gains. 

 

  Legal entity change and asset transfer: currently, the system does not support legal 
entity changes and asset transfers from one account in ePIC to another. However, the 
implementation of such a feature may require legal clarifications and/or adaptations 
to the PIC Regulation.  

  Rules governing the verification and forwarding  of export notifications and SRIN 
requests for substances belonging to a group entry: should the current approach be 
revised changes may be required/needed in ePIC for the processing of notifications 
for  group  entries  substances,  and  in  particular  regarding  the  estimated  quantities 
declared for Special RIN requests (e.g. re-introducing the business rule on quantities) 
and the forwarding rules for standard export notifications. 

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’s website section dedicated to chemicals subject to PIC provides the following:  
  Chemicals subject to PIC: the chemicals subject to PIC and listed in its Annex I (all 
Parts) or Annex V (Part 1 only), can be searched (full/sub-lists per chemical name, 
per EC  or CAS  number), with  the possibility to  apply specific filters  (e.g. on use 
category, use limitation); the Annex V, part 2 is also published but not searchable 
(yet). 

  Export notifications: non-confidential data on exports notifications can be searched, 
and high-level statistics (summaries by importing EU Member State, by exporting 
non-EU country, by chemical/ mixture/ article and per month) found.  
Import notifications: non-confidential data on import notifications can be searched, 
and high-level statistics (summaries by exporting EU Member State, by importing 
non-EU country) found.  

 

  Explicit consents: non-confidential data on explicit consents received from non-EU 

countries can be searched. 

  EU and non-EU Designated National Authorities up-to-date 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.  

70 

 
 
 
 
 
Reports on actual quantities of PIC chemicals exported and imported (pursuant to Article 
10) can be found for each year of the reporting period on the page ‘Annual reporting on PIC 
exports and imports’.  

A  link  to  the  Database  of  Import  Responses  on  the  Rotterdam  Convention’s  website  is 
provided on the Agency’s webpage dedicated to the PIC Regulation.  

During the reporting period, the Agency published the first Report on the operation of the 
PIC  Regulation  (pursuant  to  Article  22)  in  2017  and  the  second  Report  on  information 
exchange (pursuant to Article 20) in 2018.  

ECHA is also reporting on a yearly basis on its main activities and achievements, as well as 
on its workload and resources in the implementation of the PIC Regulation, as part of its 
annual General Reports.  

As in the previous reporting period, the 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.  

The indirect feedback received from industry related to the difficulty to get, in particular for 
open-ended group entries, the overview of substances subject to PIC. ECHA also received 
some feedback that it is not necessarily easy to identify newly added substances/entries. This 
issue was addressed in late 2017 by the addition of the “Chemicals latest” section in ePIC. 

The Agency also received some valuable feedback from Non-Governmental Organizations 
on  the  availability  and  accessibility  of  the  PIC  data  on  the  ECHA  website,  in  particular 
suggestions  for  the  dissemination  of  more  data  and/or  in  a  different  manner  than  it  is 
proposed  to  date.  Regarding  the  scope  of  the  data  to  be  published,  the  main  suggestions 
related to information from individual export notifications (i.e. no aggregated data) on the 
foreseen  uses  of  the  chemicals  in  the  importing  country,  the  expected  yearly  amounts  of 
chemicals to be exported, the name of the EU exporters and, when applicable, the names of 
the mixtures and the concentration of the PIC substances in them. The other main request 
related to the data stemming from the yearly Article 10 reporting procedure, which is asked 
to be published in a much less aggregated and different manner than it is today, in order to 
be able to identify the trade of PIC chemicals at the level of individual exporting EU Member 
States and non-EU importing countries. 

71 

 
 
 
 
 
 
 
Annex 

Report of the European 
Commission on the Operation 
of the PIC Regulation (EU) No 
649/2012 

72 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents 

INTRODUCTION ..................................................................................................... 75 

INTERNAL WORK OF THE COMMISSION ........................................................ 76 

2.1. 

Internal organisation and resources ................................................................. 76 
2.1.1.  Resources........................................................................................... 76 
2.1.2.  The Agency’s budget......................................................................... 76 
2.1.3.  Coordination between the Commission and the Agency .................. 76 
2.1.4.  Coordination between the Commission and DNAs .......................... 77 
2.2.  Policy work ..................................................................................................... 77 
2.2.1.  Amendments of Annexes I and V to the PIC Regulation.................. 77 
2.2.2.  Union import decisions ..................................................................... 81 
2.2.3.  Guidance to Member States on the legal interpretation of the PIC 

2.3. 

Regulation ......................................................................................... 82 
Implementation and enforcement of the PIC Regulation ................................ 82 
2.3.1.  Emergency situations (Article 8(5)) and waivers (Article 14(7)) ..... 82 
2.3.2.  Enforcement of the PIC Regulation .................................................. 83 

INTERNATIONAL WORK OF THE COMMISSION ............................................ 83 

3.1.  Preparation, coordination and submission of EU input to the Secretariat, the 

COP, the CRC and other subsidiary bodies .................................................... 84 

3.2.  Communication  of  information  to  the  Secretariat  of  the  Rotterdam 

Convention ...................................................................................................... 86 
3.3.  Financial contribution to the Rotterdam Convention ...................................... 87 
3.4.  Exchange of information (Article 20) ............................................................. 88 

 
 
 
 
 
 
 
 
 
Abbreviations used  

BPR 
CAS 
CoP 
CRC 
DNA 
DRPI 
ECHA 
FRA 
ICSMS 

PIC 
POPs 
PPPR 
REACH 

WPIEI 

Biocidal Products Regulation 
Chemical Abstracts Service 
Conference of the Parties to the Rotterdam Convention 
Chemical Review Committee 
Designated National Authority 
Directive Related Product Information 
European Chemicals Agency 
Final Regulatory Action 
Information  and  communication  system  for  the  pan-European  market 
surveillance 
Prior Informed Consent 
Persistent Organic Pollutants 
Plant Protection Products Regulation 
Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
Regulation 
Council Working Party on International Environment Issues 

74 

 
 
 
 
 
1  INTRODUCTION  

Article 22 of Regulation (EU) No 649/201244 (‘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 for the period 2017-2019 is the second under the PIC Regulation. 
The present report is the Commission report on the performance of the functions for which 
it is responsible under the PIC Regulation. As per Article 22(2), the information provided in 
this report will be incorporated in the synthesis report on the operation of the PIC Regulation, 
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,  ECHA’s  website  and  reports,  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 first  addressing the European Union internal 
work  of  the  Commission,  and  the  second  addressing  the  international  work  of  the 
Commission,  as  the  EU  DNA,  coordinator  of  input  provided  by  the  EU  and  its  Member 
States, and representative of the EU under the Rotterdam Convention. 

Table 1 : List of relevant documents consulted 

List of relevant documents consulted 
Implementing and delegated acts  

  Commission Delegated Regulation (EU) 2018/172 of 28 November 2017 amending Annexes I and 

V to Regulation (EU) No 649/2012 (OJ L 32, 6.2.2018, p. 6–11).  

  Commission Delegated Regulation (EU) 2019/330 of 11 December 2018 amending Annexes I and 

V to Regulation (EU) No 649/2012 (OJ L 59, 27.2.2019, p. 1–7).  

  Commission Delegated Regulation (EU) 2019/1701 of 23 July 2019 amending Annexes I and V to 

Regulation (EU) No 649/2012 (OJ L 260, 11.10.2019, p. 1–7). 

  Commission Implementing Decision of 10 October 2018 laying down the final import response on 
behalf of the Union concerning the future import of certain chemicals pursuant to Regulation (EU) 
No 649/2012 (OJ C 376, 18.10.2018, p. 12–30).  

DNA meeting documents  

  Minutes of 29th, 30th, 31st, 32nd, 33rd and 34th DNA meetings, and meeting documents.  

Rotterdam Convention’s documents  

  PIC circulars published by the Rotterdam Convention. 

ECHA’s reports on Article 20 and the Operation of the PIC Regulation  

  Overview on the exchange of information under Article 20 of the PIC Regulation 2016-2017.  
  Report on the exchange of information under the PIC Regulation in years 2018-2019.  
  ECHA (2020) Report on the operation of the Prior Informed Consent (PIC) Regulation 2020. 

44 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.  

75 

 
 
 
 
 
 
                                                 
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 has one policy coordinator 
responsible  for  carrying  out  the  Commission’s  administrative  functions  under  PIC.  The 
policy  coordinator  is  supported  by  a  policy  officer,  a  lawyer  for  legal  questions  and  a 
secretary for all organisational work. For international work, Unit B.2 had two experts (the 
policy coordinator and a policy officer) 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.2  (bilateral  and  regional  environmental 
cooperation)  contribute  to  the  technical  assistance  contracts  on  implementation  of  the 
Rotterdam  Convention  and  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, 0.3 FTE for policy officer/legal 
officer, and 0.1 FTE for the supporting work, including international matters. 

2.1.2  The Agency’s budget  

According to Article 24(1), 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  2017-2019  was  set  by  the  Commission  as  part  of  its  Multiannual  Financial 
Framework 2014-2020.  

According to Article 24(3), the Commission must examine whether it is appropriate for the 
Agency to charge a fee for the services provided to exporters and, if so, submit a proposal. 
The Commission tendered a study in 2019 to fulfil this obligation. The study analysed the 
implementation of fee systems used by DNAs, analysed the costs of the different services 
provided by ECHA under the PIC Regulation and developed several options for a fee system, 
including an assessment of the financial and technical feasibility and appropriateness of the 
options for the different stakeholder groups impacted (ECHA, exporters, and DNAs), as well 
as of potential impacts on the overall implementation of the PIC Regulation and on trade. 
The study was completed in June 2020.  

2.1.3  Coordination between the Commission and the Agency 

The  Commission  and  the  Agency  cooperate  closely  in  the  implementation  of  the  PIC 
Regulation. 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 information sheets produced by the Agency 
(for instance, the information sheet on waivers45)and to the work of the Forum on Exchange 
of Information on Enforcement, in particular to the pilot project on the control of PIC duties, 

45 Proposing waivers through ePIC: https://echa.europa.eu/proposing-waivers-through-epic  

76 

 
 
                                                 
carried out by the Forum in 201846The Commission contributed to the project manual drafted 
by the Forum, which was then used by Member States for implementation of the project.  

For cooperation with non-EU 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 the PIC Regulation. 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 PIC 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 the PIC Regulation. The procedure 
for adoption of delegated acts requires the Commission to consult Member states’ experts 
on draft amendments. Draft delegated acts are presented at the DNA meetings in order to 
ensure that all Member State experts, as well as observers, have the opportunity to comment. 
Draft delegated acts are also subject to a four-week public consultation, where any citizen 
or stakeholder can provide feedback on the act. Adopted delegated acts are also scrutinised 
by the European Parliament and the Council to ensure that the Commission does not exceed 
its  powers.  Once  the  act  is  adopted,  the  Parliament  and  Council  have  two  months  to 
formulate any objections. If no objections are raised, the act enters into force.  

2.2.1.1  2.2.1.1 

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.  

Amendments  to  Part  3  of  Annex  I  reflect  the  decisions  of  the  CoP  to  include  certain 
chemicals in Annex III to the Convention, making them subject to the PIC procedure. 

46 ECHA (2018) Final report of the Forum pilot project on the control of PIC.  

77 

 
 
 
                                                 
During the reporting period, three Delegated Regulations amending Annex I were adopted, 
in 2017, 2018 and 2019:  

  Commission Delegated Regulation (EU) 2018/172 of 28 November 2017 amending 
Annexes I and V to Regulation (EU) No 649/2012 (OJ L 32, 6.2.2018, p. 6–11).  
  Commission Delegated Regulation (EU) 2019/330 of 11 December 2018 amending 
Annexes I and V to Regulation (EU) No 649/2012 (OJ L 59, 27.2.2019, p. 1–7).  
  Commission  Delegated  Regulation  (EU)  2019/1701  of  23  July  2019  amending 
Annexes I and V to Regulation (EU) No 649/2012 (OJ L 260, 11.10.2019, p. 1–7).  

Substances added to Annex 1  

Of the 37 substances added to Annex I during the reporting period, 23 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’,  as  shown  in  Table  2.  Three 
substances were added to Parts 1 and 2 of Annex I following their non-approval for use in 
biocidal products in accordance with the BPR (Regulation (EU) No 528/2012). Five were 
added  to  Parts  1  and  2  of  Annex  I  because  they  were  severely  restricted  as  industrial 
chemicals for public use under the REACH Regulation. Finally, six were included in Part 3 
of Annex I following their inclusion in Annex III to the Rotterdam Convention. 

Table 2 : Substances added to Annex 1 during the reporting period 

Delegated Act 

Chemical  

Commission 
Delegated 
Regulation  (EU) 
2018/172  of  28 
November  2017 
amending 
Annexes  I  and  V 
Regulation 
to 
(EU) 
No 
649/2012 

3-decen-2-one 
5-tert-butyl-2,4,6-
trinitro-m-xylene 
Benzyl butyl phthalate 
Carbendazim 
Cybutryne 
Diisobutyl phthalate 
Diarsenic pentaoxide 
Tepraloxydim 

Triclosan 
Triflumuron 
Tris 
phosphate 
Methamidophos 

(2-chloroethyl) 

Amendment of Annex 
I 

CAS 
number 
10519-33-2  Part 1 and 2 
Parts 1 and 2 
81-15-2 

Parts 1 and 2 

85-68-7 
10605-21-7  Part 1 
28159-98-0  Parts 1 and 2 
Parts 1 and 2 
84-69-5 
Parts 1 and 2 
1303-28-2 
Parts 1 and 2 
149979-41-
9 
3380-34-5 
64628-44-0  Part 1 
115-96-8 

Parts 1 and 2 

Parts 1 and 2 

10265-92-6  Parts 1 and 3 

Commission 
Delegated 
Regulation  (EU) 
2019/330  of  11 
December  2018 
amending 
Annexes  I  and  V 
Regulation 
to 
(EU) 
No 
649/2012 

Amitrole 
Beta-cypermethrin 
Carbofuran 

61-82-5 
Parts 1 and 2 
65731-84-2  Parts 1 and 2 
Parts 1 and 3 
1563-66-2 

DPX 
(flupyrsulfuron-methyl) 

KE 

459 

Fipronil 

Iprodione 
Isoproturon 
Linuron 

Parts 1 and 2 

150315-10-
9 
144740-54-
5 
120068-37-
3 
36734-19-7  Parts 1 and 2 
34123-59-6  Parts 1 and 2 
Parts 1 and 2 
330-55-2 

Parts 1 and 2 

Basis for inclusion  

PPPR 
REACH 

REACH 
PPPR 
BPR 
REACH 
REACH 
PPPR 

BPR 
BPR 
REACH 

Annex  III  Rotterdam 
Convention 
PPPR 
PPPR 
Annex  III  Rotterdam 
Convention  
PPPR 

PPPR 

PPPR 
PPPR 
PPPR 

78 

 
 
 
 
 
 
Delegated Act 

Chemical  

Maneb 
Orthosulfamuron 

Picoxystrobin 

Short-chain  chlorinated 
paraffins 
Triasulfuron 
Trichlorfon 

Amendment of Annex 
I 

CAS 
number 
12427-38-2  Parts 1 and 2 
Parts 1 and 2 
213464-77-
8 
117428-22-
5 
85535-84-8  Part 3 

Parts 1 and 2 

82097-50-5  Parts 1 and 2 
Parts 1 and 3 
52-68-6 

2-naphthyloxyacetic acid   120-23-0 
Acetochlor 
Asulam 

Commission 
Delegated 
Regulation  (EU) 
2019/1701  of  23 
July 
2019 
amending 
Annexes  I  and  V 
Regulation 
to 
(EU) 
No 
649/2012 

Chloropicrin 
Diphenylamine 
Flufenoxuron 

Naled 
Propanil 
Propargite 
Alachlor 

Aldicarb 

Part 2  

Parts 1 and 2 
Part 2 
Parts 1 and 2 

34256-82-1  Parts 1 and 2 
Parts 1 and 2 
3337-71-1 
2302-17-2 
76-06-2 
122-39-4 
101463-69-
8 
300-76-5 
709-98-8 
2312-35-8 
15972-60-8  Part 3 

Parts 1 and 2 
Part 2 
Parts 1 and 2 

116-06-3 

Part 3 

Endosulfan 

115-29-7 

Part 3 

Basis for inclusion  

PPPR 
PPPR 

PPPR 

Annex  III  Rotterdam 
Convention  
PPPR 
Annex  III  Rotterdam 
Convention  
PPPR 
PPPR 
PPPR 

PPPR 
PPPR 
PPPR 

PPPR 
PPPR 
PPPR 
Annex  III  Rotterdam 
Convention  
Annex  III  Rotterdam 
Convention  
Annex  III  Rotterdam 
Convention  

Substances included in Part 3 of Annex I during the reporting period, with the exception of 
short-chain chlorinated paraffins, had already been included in Parts 1 and 2 of Annex I to 
the  PIC  Regulation.  Following  to  their  inclusion  in  Annex  III  to  the  Convention, 
corresponding entries in Part 2 of Annex I were deleted and entries in Part 1 of Annex I were 
amended accordingly.  

The  substance  methamidophos  (CAS  no  10265-92-6)  was  included  in  Annex  III  to  the 
Convention. As a result, the existing entry in Annex III to the Convention concerning that 
substance ‘methamidophos (soluble liquid formulations of the substance that exceed 600 g 
active  ingredient/l)’  was  deleted  and  replaced  by  a  new  entry  for  ‘methamidophos’. 
Commission  Delegated  Regulation  (EU)  2018/172  deleted  the  existing  entry  in  Part  2  of 
Annex I, and replaced the existing entries in Parts 1 and 3 of Annex I by a new one, reflecting 
the changes made to Annex III to the Convention.  

Entries of Annex I modified during the reporting period  

Tributyltin compounds were already included in Annex III to Convention in the use category 
‘pesticide’ since 2008. In 2017, the CoP included tributyltin compounds in Annex III in the 
use  category  ‘industrial’.  As  a  result,  tributyltin  compounds  became  subject  to  the  prior 
informed consent procedure under the Convention in the use category ‘industrial’ as well as 
‘pesticide’. In addition, tributyltin compounds were added in 201747 to substances covered 

47 Commission Regulation (EU) 2017/1510 of 30 August 2017 amending the Appendices to Annex XVII to Regulation 
(EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH) as regards CMR substances. OJ L 224, 31.8.2017, p. 110–114.  

79 

 
 
 
 
                                                 
by Entry 30 of Annex XVII to REACH (restriction on substances, which are classified as 
reproductive toxicant category 1A or 1B listed in appendices to the Annex). Commission 
Delegated Regulation (EU) 2019/330 replaced existing entries in Parts 1 and 3 of Annex I 
to the PIC Regulation by new entries, reflecting changes made under the Convention and the 
REACH Regulation.  

Entries  concerning  dichlorvos  in  Parts  1  and  2  of  Annex  1  to  the  PIC  Regulation  were 
amended  by  Commission  Delegated  Regulation  (EU)  2019/1701  to  reflect  Commission 
Decision 2012/254/EU not to include dichlorvos in Annex I, IA or IB to Directive 98/8/EC, 
which results in dichlorvos being banned from pesticide use.  

Substances removed from Annex I  

By  Implementing  Regulations  (EU)  No  582/2012  and  (EU)  No  359/2012,  bifenthrin  and 
metam were approved, respectively, under the PPPR, with the effect that those substances 
were no longer banned from pesticide use. As a result, the entries concerning bifenthrin and 
metam were deleted from Part 1 of Annex I.  

2.2.1.2  2.2.1.2 

Amendments to Annex V  

Amendments to Part 1 of Annex V to the PIC Regulation (chemicals subject to export ban) 
are triggered by the inclusion of a substance in Annex I to the POPs Regulation (Regulation 
(EC) 850/200448, replaced in 2019 by Regulation (EU) 2019/102149). During the reporting 
period, the following substances were added to Part 1 of Annex V.  

Table 3 : Substances added to Part 1 of Annex V during the reporting period  

Legal act 
Commission Delegated 
Regulation (EU) 2018/172 of 
28 November 2017 amending 
Annexes I and V to Regulation 
(EU) No 649/2012 

Chemical 
Hexachlorobutadiene 
Polychlorinated naphthalenes 
Hexabromocyclododecane 

Tetrabromodiphenyl ether 
Pentabromodiphenyl ether 
Hexabromodiphenyl ether 
Heptabromodiphenyl ether 
Short-chain chlorinated paraffins 

CAS number 
87-68-3 
70776-03-3 and others 
25637-99-4, 3194-55-6, 134237-50-
6,  134237-51-7,  134237-52-8  and 
others 
40088-47-9 and others 
32534-81-9 and others 
36483-60-0 and others 
68928-80-3 and others 
85535-84-8 

Commission Delegated 
Regulation (EU) 2019/330 of 
11 December 2018 amending 
Annexes I and V to Regulation 
(EU) No 649/2012 
Commission Delegated 
Regulation (EU) 2019/1701 of 
23 July 2019 amending 
Annexes I and V to Regulation 
(EU) No 649/2012 

Endosulfan 

115-29-7 

48 Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic 
pollutants and amending Directive 79/117/EEC, OJ L 158, 30.4.2004, p. 7–49. This Regulation was in force for most of 
the  reporting  period  before  being  replaced  in  2019  by  Regulation  (EU)  2019/1021.  Among  other  changes,  the  recast 
clarified certain definitions and aligned them with the definitions used in other chemical and waste regulations and updated 
the Annexes of the Regulation to comply with the Stockholm Convention.  
49  Regulation  (EU)  2019/1021  of  the  European  Parliament  and  of  the  Council  of  20  June  2019  on  persistent  organic 
pollutants, OJ L 169, 25.6.2019, p. 45–77.  

80 

 
 
 
 
 
                                                 
Part 2 of Annex V to the PIC Regulation lists chemicals subject to export ban other than 
POPs. To reflect changes brought by Regulation (EU) 2017/852, which modifies the rules 
on  the  export  of  mixtures  of  metallic  mercury  with  other  substances  with  a  mercury 
concentration  of  less  than  95  %,  and  of  certain  mercury  compounds,  entries  in  Part  2  of 
Annex V concerning such mercury compounds and mixtures were amended by Commission 
Delegated Regulation (EU) 2019/330.  

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  Union  import  decision  is  adopted  by  means  of  an 
implementing act of the Commission. The Commission services draft 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 one Implementing Decision in 2018 
(see Table 4). The Implementing Decision provided new import decisions for carbofuran, 
trichlorfon, short-chain chlorinated paraffins, tributyltin compounds and amended the import 
decision on ethylene oxide.  

Table 4 : Union import responses adopted during the reporting period  

Implementing 
Act 
Commission 
Implementing 
Decision of 10 
October 2018 

Chemicals 

CAS number  Nature / status of 

Carbofuran 

1563-66-2 

Trichlorfon 

52-68-6 

Short-chain 
chlorinated 
paraffins 

Tributyltin 
compounds  

Ethylene Oxide  

85535-84-8 

56-35-9; 1983-
10-4; 2155-70-
6;  4342-36-3; 
1461-22-9; 
24124-25-2; 
85409-17-2 
75-21-8 

decision  
New 
decision 
New 
decision 
New 
decision 

Final  

Final  

Final  

New 
decision 

Final  

Modifica
tion 

Final 

Import 
decision 
No consent 
to import 
No consent 
to import 
Consent to 
import only 
subject to 
specified 
conditions 
Consent to 
import only 
subject to 
specified 
conditions 

Consent to 
import only 
subject to 
specified 
conditions 

Grounds for 
decision 
Banned for use by 
PPPR 
Banned for use by 
PPPR 
Banned for use by 
POPs Regulation 
– specific 
derogation  

Restricted by 
Annex XVII to 
REACH (entry 20 
on organostannic 
compounds)  

Banned for use by 
PPPR / restricted 
for use by BPR to 
certain products 
subject to 
Member States’ 
decision  

81 

 
 
 
 
 
 
 
 
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).  

Table 5 : Implementation issues discussed at DNA meetings 

DNA meeting 
29th DNA meeting (April 2017) 

30th DNA meeting (October 2017) 

31st DNA meeting (April 2018) 

32nd DNA meeting (October 2018) 

33rd DNA meeting (April 2019) 

34th DNA meeting (October 2019) 

Implementation issues discussed 
Proposal for bulk special RIN request template 
Export  of  certain  cadmium  compounds  /  of  mixtures 
containing cadmium compounds 
Proposal for bulk special RIN request template 
“Invented” export notifications 
Validity of evidence presented to obtain a waiver 
Scope of Article 17 of the PIC Regulation  
Contradictory  explicit  consent  responses  related  to  the 
same substance  
Conditions of acceptance of waivers  
Special  RIN  requests  pursuant  to  Article  2(3)  of  the  PIC 
Regulation 
Export of cholecalciferol 
Duplicate export notifications submitted by exporters  
Responses  to  explicit  consent  requests  for  biocidal 
products 
Export notifications for uses in veterinary products 
Responses  to  explicit  consent  requests  for  industrial 
chemicals from Morocco  
Handling  of  substances  containing  impurities  under  the 
PIC Regulation  

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 a chemical listed in Parts 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 
addition,  when  a  chemical  listed  in  Part  2  of  Annex  I  is  exported  to  an  OECD  country, 
according to Article 14(6), the DNA of the exporter’s Member State ‘may, at the request of 
the exporter, in consultation with the Commission and on a case-by-case basis, decide that 
no explicit consent is required if the chemical,  at the time of importation into the OECD 

82 

 
 
 
 
 
 
 
country concerned, is licensed, registered or authorised in that OECD country’ (procedure 
known as ‘OECD waiver’).  

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  previous  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), 
as it will be the most suitable tool once it has been adapted and customised to the needs of 
PIC  enforcement  authorities.  The  Forum  accepted  ICSMS  as  the  Electronic  Information 
Exchange System for PIC. As for the REACH and CLP Regulations, the objective was to 
create a specific Directive Related Product Information (DRPI) form for the PIC Regulation. 
Specifications  for  the  PIC  DRPI  were  drafted  by  the  Forum  Working  Group  ICSMS,  in 
response to a Commission request. The Commission implemented the PIC DRPI into ICSMS 
after finalising the REACH and CLP DRPI. The integration of PIC in ICSMS was finalised 
in the first half of 2018.  

The  Commission  also  contributed,  during  the  reporting  period,  to  the  first  Forum  pilot 
project  on  the  PIC  Regulation,  to  which  thirteen  Member  states  participated.  The  pilot 
project focused on PIC exports and in particular on the implementation of Articles 8, 14, 15 
and 17 of the PIC Regulation. A total of 296 inspections were completed by Member States, 
consisting  of  both  on-site  and  desktop  inspections50.  The  Commission  contributed  to  the 
project  manual  drafted  by  the  Forum,  which  was  then  used  by  Member  States  for 
implementation of the project.  

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.  

50 ECHA (2018) Final report of the Forum pilot project on the control of PIC. 

83 

 
 
 
 
                                                 
  Submission to the Secretariat of Union import responses for chemicals subject to the 

PIC procedure.  

  Exchange of information with the Secretariat in general.  

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  

  8th and 9th Conferences of the Parties (CoP) to the Rotterdam Convention 

During the reporting period, the Commission represented the EU at the 8th CoP, which took 
place from 24 April to 05 May 2017, and at the 9th CoP, which took place from 29 April to 
10 May 2019.  

CoP-8 (24 April to 05 May 2017)  

Replying to an invitation of the Secretariat, the Commission submitted comments on behalf 
of the European Union on the listing in Annex III of chemicals that had been recommended 
by the CRC for listing. Those comments were agreed in WPIEI before their submission. 

The  Commission  contributed  to  the  drafting  of  EU  and  its  Member  States  comments  on 
amendments proposed by other Parties, i.e. the proposals to amend Articles 16 and 22 of the 
Convention.  Those  comments  were  agreed  in  WPIEI  and  submitted  to  the  Secretariat  on 
behalf of the EU and its Member States. 

Before the CoP, the Commission prepared a proposal for a Council Decision establishing 
the position to be adopted on behalf of the European Union within the Conference of the 
Parties with regard to amendments of Annex III to the Rotterdam Convention (COM(2017) 
73 final), to get the mandate for the participation in the decision-making at the CoP. The 
proposal was submitted to the Council in February 2017 and adopted on 3 April 2017.  

In addition, the Commission contributed to the drafting of the position paper of the EU and 
its Member States and to the corresponding statements for their participation in the CoP. The 
position paper and statements cover all agenda items of the meeting.  
Before the 8th meeting of the CoP, the Commission also consulted DNAs on the possibility 
to  organise  meetings  at  the  8th  Conference  of  the  Parties  between  the  European  Union, 
Member States, and relevant third countries and regions, following the positive experience 
of such meetings at the 7th meeting of the CoP.  

During the CoP, the Commission represented the EU and the EU and its Member States in 
contact groups and in any bilateral meetings with Parties, the Secretariat of the Convention 
and other stakeholders, and contributed to the drafting of Conference Room Papers. 
After CoP 8, the Commission presented the outcomes of the CoP to DNAs at the 30th DNA 
meeting on 3 October 2017. 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 19 
June 2017.  

CoP-9 (29 April to 10 May 2019)  

Before the CoP, 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 

84 

 
 
 
consisted of:  

  Proposal for a Council Decision establishing the position to be adopted on behalf of 
the European Union within the Conference of the Parties with regard to amendments 
of Annex III to the Rotterdam Convention (COM(2019) 54 final) to get the mandate 
for the participation in the decision-making at the CoP. The proposal was submitted 
to the Council in February 2019 and adopted on 15 April 2019.  

  Comments on amendments proposed by Parties – proposals to amend Articles 16 and 

22 of the Convention,  

  comments on the report on legal and operational implications of priority actions to 
enhance  the  effectiveness  of  the  Rotterdam  Convention,  prepared  by  the  working 
group.  

  Commission proposal for a Council Decision on the position to be taken on behalf of 
the European Union at the Conference of the Parties to the Rotterdam Convention 
regarding compliance procedures, regarding the proposal to be discussed at the CoP 
to  adopt  an  additional  procedural  annex  in  order  to  introduce  a  non-compliance 
mechanism as required by Article 17 of the Convention. 

As for the previous CoP, the Commission contributed to the drafting of the position paper 
of the EU and its Member States and to the corresponding statements for their participation 
in the CoP. The position paper and statements cover all agenda items of the meeting. 

During the CoP, the Commission represented the EU and the EU and its Member States in 
contact groups and in any bilateral meetings with Parties, the Secretariat of the Convention 
and other stakeholders, and contributed to the drafting of Conference Room Papers. As for 
the previous CoP, and based on the positive experience with the meetings held at the 8th 
CoP between the European Union and its Member States and some groups of third countries, 
the Commission consulted DNAs on the organisation of such meetings during the 9th CoP.  
After CoP 9, the Commission presented the outcomes of the CoP to DNAs at the 34th DNA 
meeting on 15 October 2019. 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 26 
June 2019.  

Intersessional work on enhancing the effectiveness of the Rotterdam Convention 

Following the intersessional work on the process of listing chemicals in  Annex III to the 
Convention and to develop options for improving the effectiveness of the listing process and 
information flows, which was carried out by a working group between the 7th and the 8th 
meeting  of  the  CoP,  the  CoP  reviewed,  during  the  8th  meeting,  options  to  improve  the 
effectiveness  of  the  Rotterdam  Convention,  agreed  on  further  work  to  be  done  in  the 
intersessional period and established a working group to identify priority actions to improve 
the effectiveness of the Convention.  
After the 8th CoP, the Secretariat of the Convention developed an online survey to be filled 
by  Parties  by  31  October  2017  to  gather  information  on  priority  actions  to  enhance  the 
effectiveness  of  the  Convention.  The  Commission,  as  the  EU  DNA,  coordinated  the  EU 
submission – preparing the draft, inviting DNAs to comment, and submitting the final draft.  

Following the survey, the working group made a compilation of submissions and drafted a 
report on the legal and operational implications of priority actions proposed to enhance the 
effectiveness of the Rotterdam Convention. The Commission coordinated the submission of 
EU comments on some of these suggestions.  

85 

 
 
 
The Commission attended the meetings of the working group, along with representatives of 
some  Member  States,  and  reported  on  the  progress  of  the  intersessional  work  at  DNA 
meetings. Financial support for the intersessional work was provided by the EU through the 
Commission. 

Participation in committees and expert groups  

Members of the Commission participated as experts in the various Convention bodies, along 
with experts from Member States:  

  a Commission official was nominated as expert to participate in the CRC by Spain 
and acted as Chair of the first meeting of the CRC that occurred during the reporting 
period (13th meeting 23–27 October 2017).  

  Another Commission official was nominated as expert to participate in the CRC by 

Malta and started to serve on 1 May 2018. 

  The intersessional working group on enhancing the effectiveness of the Rotterdam 
Convention (see below), where one Commission official represented the European 
Union.  

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, supported by ECHA, drafts the notifications, which 
are  submitted  to  DNAs  and  observers  for  comments  before  being  submitted  to  the 
Secretariat.  

Ten notifications were submitted to the Secretariat during the reporting period51:  

  Acetochlor (2017)  
  Amitrole (2019) 
  Beta-cypermethrin (2019)  
  Cybutryne (2019) 
  Flupyrsulfuron-methyl (2019) 
 
Iprodione (2019) 
 
Isoproturon (2019) 
  Orthosulfamuron (2019) 
  Picoxystrobin (2019) 
  Triasulfuron (2019) 

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  Union  import  decisions  to  the 

51  Rotterdam  Convention,  Country  profiles  –  European  Union,  Notifications  of  Final  Regulatory  Action 
(http://www.pic.int/Countries/CountryProfiles/tabid/1087/language/en-US/Default.aspx)  and  FRA notifications  provided 
by the Commission.  

86 

 
 
 
 
 
 
                                                 
Secretariat  of  the  Rotterdam  Convention.  The  new  import  decisions  for  carbofuran, 
trichlorfon, short-chain chlorinated paraffins, tributyltin compounds and the amended import 
decision on ethylene oxide were published on the Convention website in December 2018.  

Ad-hoc Secretariat requests  

The  Commission  replied  to  a  number  of  information  requests  from  the  Rotterdam 
Convention Secretariat:  
At the 7th CoP, the COP requested the Secretariat to facilitate the exchange of information 
and report to each meeting of the Conference of the Parties on the implementation of Articles 
11  (paragraph  2),  12  and  14  of  the  Convention.  The  Commission  drafted  a  reply  to  the 
Secretariat’s questionnaire with the help of ECHA, who provided the data requested in the 
questionnaire, and  consulted the Member States.  The data  for 2016  was submitted to  the 
Secretariat  on  25  September  2018  and  the  data  for  2017  in  January  2019.  Following  the 
development by ECHA of an algorithm to cover mixtures, full data, as well as revised data 
sets for 2016 and 2017, were submitted in January 2019.  
Following the 8th CoP, the Secretariat of the Convention also launched a request for input 
on  synergies  between  the  three  Conventions  (Rotterdam,  Stockholm,  and  Basel)  in 
preventing and combating illegal traffic and trade in hazardous chemicals and wastes. In the 
Working  Party  on  International  Environment  Issues  (WPIEI),  it  was  decided  that  the 
Commission together with the Presidency would prepare a common line for the reply for 
those sections that are mainly linked to Union legislation. The common line prepared was 
made available to the Member States via the delegates portal.  

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 the Special Voluntary Trust Fund for the implementation of the programme of work for 
technical assistance (see Table 6).  

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. 

Table 6:  Financial contributions from the EU to the Rotterdam Convention’s Trust Fund and Special 
Voluntary Trust Fund (in EUR, converted from USD to EUR with the exchange rate of the 
time of payment/commitment) 

Year 

2017 
2018 
2019 

EU Contribution to Trust Fund52 

EU Contribution to Special Voluntary Trust 
Fund53 

62 512 
63 316 
68 661 

336 750 
551 000 

52 The contributions published on the Convention website are calculated in USD. These are the amounts paid in EUR.  
53 Commitments in accordance with the agreement concluded with the Secretariat of the Convention in the respective 
year.  

87 

 
 
 
 
 
 
 
 
                                                 
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.  

As mentioned in the previous report, the Commission replied to four requests in the period 
2016-2017  from  four  countries  (Canada,  Indonesia,  Lebanon  and  Syrian  Arab  Republic) 
concerning four chemicals54. During the period 2018-2019, the Commission did not receive 
any ad-hoc requests falling within the scope of Article 20 of the PIC Regulation55. 

54 ECHA, Overview on the exchange of information under Article 20 of the PIC Regulation 2016-2017. Compilation of the 
information collected by the European Commission, assisted by the Member States and the European Chemicals Agency, 
ECHA-2018-R-20-EN, November 2018: 
https://echa.europa.eu/documents/10162/21728206/pic_article_20_report_2016-2017_en.pdf/f305378c-713c-bcd7-f2d7-
03ac2400e679  
55  ECHA,  Report  on  the  exchange  of  information  under  the  PIC  Regulation  in  years  2018-2019.  Compilation  of  the 
information transmitted by the European Commission, the Member States and the European Chemicals  Agency, under 
Article 
2020: 
https://echa.europa.eu/documents/10162/21728206/pic_article_20_report_2018-2019_en.pdf/f3ed3740-bd90-c7da-cebe-
0e4a6a77ef2c  

ECHA-20-R-15-EN, 

Regulation, 

PIC 

the 

20 

of 

88