COMMISSION STAFF WORKING DOCUMENT Synthesis Report on the Operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals for the period 2020 - 2022 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 for the period 2020-2022
Date: 2025-09-30
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), public health

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 30.9.2025  SWD(2025) 278 final  COMMISSION STAFF WORKING DOCUMENT Synthesis Report on the Operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals for the period 2020 - 2022 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 for the period 2020-2022  {COM(2025) 557 final}  
 
 
Table of contents 

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The PIC Regulation 
Exclusion of Great Britain (GB) and Northern Ireland (NI) 
The reporting exercise 

1 

INTRODUCTION 
1.1 
1.2 
1.3 
1.4  Methodology 
1.4.1 
1.4.2 

Preparation of the Commission’s report 
Implementation of the common format for reporting for Member States 
in the form of a web-based questionnaire 
Synthesis of Member States’ reporting 

1.4.3 
1.4.4  Drafting the Synthesis Report and summary 

2  GOVERNANCE OF THE PIC REGULATION 

2.1  Organisation of the implementation of the PIC Regulation 

2.2 

2.3 

European Commission 
European Chemicals Agency (ECHA or the Agency) 

2.1.1 
2.1.2 
2.1.3  DNAs 
Coordination between the Commission, the Agency and Designated National 
Authorities 
2.2.1  Coordination between the Commission and the DNAs 
2.2.2  Coordination between the Agency and the DNAs 
2.2.3  Coordination between the Commission and the Agency 
The EU as a Party to the Rotterdam Convention 
2.3.1  Coordination of EU input to the Conference of the Parties (CoP) 
2.3.2 
2.3.3 

Participation in committees and expert groups 
Financial contributions to the Rotterdam Convention 

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

3.1  Update of Annex I 
3.2  Updates of Annex V 

4  OPERATION OF THE PIC REGULATION 

4.1 

4.2 

Support provided by DNAs 
Support provided by the Agency 

Export notifications processed during the reporting period 
Special RIN requests processed during the reporting period 

Support to exporters and importers 
4.1.1 
4.1.2 
Export notifications sent to Parties and other countries (Article 8) 
4.2.1 
4.2.2 
4.2.3  Requests for resubmission and rejection of export notifications 
4.2.4  Difficulties encountered in the export notification procedure 
4.2.5 
4.2.6 
4.2.7  Administrative fee for export notifications 

Emergency situations (Article 8(5)) 
Provision of available additional information on exported chemicals 

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11 
11 
11 
15 

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20 
21 
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25 

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30 

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36 
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50 
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Export notifications from Parties and other countries (Article 9) 
Information on export and import of chemicals (Article 10) 

55 
4.3 
55 
4.4 
4.5  Notification of banned or severely restricted chemicals under the Convention  57 
4.6  Obligations in relation to importing chemicals (Article 13) 
58 
4.7  Obligations in relation to exports of chemicals, other than export notifications 

(Article 14) 
4.7.1  Communication of information and decisions to those concerned within 

59 

the jurisdiction of a Member State (Article 14(3)) 
4.7.2 
Explicit consent (Article 14(6)) 
4.7.3  Waivers (Article 14(6) and (7)) 
4.7.4  Validity of explicit consent (Article 14(8)) 
Information on transit movement (Article 16) 
Requirements linked to exported chemicals and accompanying information 
(Article 17) 

4.8 
4.9 

4.10  Enforcement of the PIC Regulation (Article 18) 

4.10.1  National enforcement authorities (NEAs) 
4.10.2  Training inspectors 
4.10.3  Enforcement strategy 
4.10.4  Enforcement activities 
4.10.5  Powers of enforcement authorities 
4.10.6 
4.10.7  Penalties 
4.10.8  Collaboration between DNAs and NEAs 
4.10.9  Forum activities 

Infringements during the reporting period 

4.11  Exchange of information (Article 20) 
4.12  Technical assistance (Article 21) 
4.13 

IT-related aspects 
4.13.1  The ePIC system 
4.13.2  User-friendliness of the ePIC system 
4.13.3  Areas of ePIC improvement 
4.13.4  Data dissemination via the Agency Website 
4.13.5 
4.13.6  Agency PIC dissemination website feedback 

Improvements to the Agency’s PIC dissemination website 

ANNEX 

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64 
65 

65 
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72 
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13 
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24 

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31 

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52 
53 

LIST OF TABLES 

Table 1. List of relevant documents consulted for the Commission Report 
Table 2. Agency’s staff working on the PIC Regulation 
Table 3. Number of export notifications predicted versus processed by the Agency 
Table 4. Number of export notifications received from other countries processed by the 

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12 
13 

Table 5. Number of requests for technical/regulatory support from the Agency13 
Table 6. Distribution of responsibilities across DNAs in Member States with more than one 

Agency13 

DNA 

Table 7. EU Members of the CRC during the reporting period 
Table 8. Financial contributions from the EU to the Rotterdam Convention’s Trust Fund and 

Special Voluntary Trust Fund (USD) 

Table 9. Member States’ contributions to the Special Voluntary Trust Fund (USD)  
Table 10. Chemicals added to Annex 1 during the reporting period 
Table 11. Chemicals added to Part 1 of Annex V during the reporting period 
Table 12. Substances added to Part 2 of Annex V during the reporting period 
Table 13. Number of export notifications accepted and forwarded to the Agency by DNAs in 

the reporting periods 2014-2016, 2017-2019, and 2020-2022 

41 

Table 14. Export notifications and related tasks handled by the Agency during the reporting 

period 

42 

Table 15. Number of Special RIN requests accepted by DNAs in the reporting periods 2014-

2016, 2017-2019 and 2020-2022 

Table 16. Number of export notifications received late by the Agency per year 
Table 17. Number of export notifications processed late by the Agency per year 
Table 18. Export notifications received from non-EU countries and acknowledgements sent 

during the reporting period 

Table 19. EU import responses adopted during the reporting period 
Table 20. Reminders for explicit consent requests sent by the Agency during the reporting 

period 

Table 21. Number of requests for explicit consent pursuant to Article 14(6)(b) 
Table 22. Number of cases where DNAs were required to decide whether or not explicit 

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58 

61 
61 

consent was required in case of export of chemicals listed in Part 2 of Annex I to 
OECD countries 

62 

Table 23. Number of waiver requests received per Member State during the reporting period

63 
Table 24. Number of cases where the export was allowed to proceed pending a reply to a new 
64 
request for explicit consent, by Member State, during the reporting period 
Table 25. Number of official controls on exports in which the PIC Regulation was covered or 
68 
Table 26. Number of official controls on imports in which the PIC Regulation was covered or 
70 

enforced during the reporting period, by Member State 

enforced during the reporting period, by Member State 

Table 27. Number of customs controls and infringements observed during the reporting 

period 

72 

Table 28. Numbers of controls carried out by inspectors and infringements observed during 

the reporting period 

Table 29. Types and numbers of infringements of the PIC Regulation observed by customs 

during the reporting period 

73 

73 

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Table 30. Types and numbers of infringements of the PIC Regulation observed by inspectors 

during the reporting period 

Table 31. Number of infringements that led to penalties during the reporting period 
Table 32. Number of ePIC users during the reporting period by type 

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81 

LIST OF FIGURES 

18 
Figure 1. Other EU legislation for which PIC DNAs are also responsible 
Figure 2: Q8. Please specify the human resources (in full-time equivalent-FTE) in the DNA(s) 
18 

working on the implementation of the PIC Regulation 

Figure 3. 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? 

Figure 4. Question 13. On which matters do(es) the DNA(s) get the two most frequent 

requests for support coming from exporters and importers? 

Figure 5. Question 14: Can you estimate the amount of time spent by the DNA(s) on such 

support? 

33 

35 

35 

Figure 6. Number of requests received by the Agency from exporters and importers since 

2014 

38 
Figure 7. Number of export notifications accepted and forwarded to the Agency by DNAs per 
40 

year 

Figure 8. Number of export notifications accepted and forwarded to the Agency by DNAs 

during the reporting period 

40 

Figure 9. Number of export notifications accepted and forwarded to the Agency by DNAs 
compared with the previous reporting period for those DNAs processing the most 
notifications 

42 
43 
Figure 10. Number of Special RIN requests accepted by DNAs per year 
Figure 11. Number of Special RIN requests accepted by DNAs during the reporting period  44 
45 
Figure 12. Number of resubmissions of export notifications requested by DNAs per year 
Figure 13. Number of resubmissions of export notifications requested by DNAs in the 

reporting period 

Figure 14: Question 20. Most frequent reasons for requesting resubmission of export 

notifications 

Figure 15. Number of resubmissions requested by the Agency per year 
Figure 16. Number of export notifications rejected by DNAs per year since 2014 
Figure 17. Number of export notifications rejected by DNAs during the reporting period 
Figure 18: Question 20. Most frequent reasons for rejecting export notification 
Figure 19. Number of export notifications rejected by the Agency per year 
Figure 20. Question 19. What are the information requirements requested in the export 

46 

47 
48 
48 
49 
49 
50 

notification form where exporters have difficulties in providing the information?  51 

Figure 21. Number of requests for explicit consent processed by DNAs during the reporting 

period 

60 

Figure 22. Comparison of number of requests for explicit consent processed by DNAs during 

the present period versus the previous period for those DNAs experiencing the 
greatest change. (% change shown in parentheses) 

60 

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Figure 23. Question 62. Does your authority (or any other relevant authority) have an 

enforcement strategy for Regulation (EU) No 649/2012? 

Figure 24. Enforcement activities carried out in Member States 
Figure 25. Measures that can be taken by enforcement authorities to ensure compliance with 

the PIC Regulation 

Figure 26. Penalties applied in case of infringement of the PIC Regulation 
Figure 27. Question 79. Is the ePIC system easy to use for DNAs? 
Figure 28. Question 80. Where possible, please provide feedback from exporters on the user- 

67 
68 

71 
74 
83 

friendliness of the ePIC system. 

84 

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Abbreviations used 

Agency 

European Chemicals Agency (ECHA) 

ATD 

BPR 

CAS 

CFL 

CLP 

CN 

CoP 

CRC 

CUS 

DNA 

Access To Document 

Biocidal Products Regulation 

Chemical Abstract Service 

Compact Fluorescent Lamps 

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 

ECHA 

European Chemicals Agency 

ePIC 

EU 

FRA 

Software application for implementing Regulation (EU) No 649/2012 

European Union 

Final Regulatory Action 

ICSMS 

Information and communication system for the pan-European market surveillance 

IPA 

IT 

NEA 

NGO 

EU Instrument for Pre-accession Assistance 

Information technology 

National Enforcement Authority 

Non-Governmental Organisation 

OECD 

Organisation for Economic Cooperation and Development 

OJ 

PIC 

Official Journal of the European Union 

Prior Informed Consent 

PFOA 

Perfluorooctanoic acid 

PFOS 

POPs 

PPPR 

Perfluorooctanate sulfonate 

Persistent Organic Pollutants 

Plant Protection Products Regulation 

REACH  Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation 

RoHS 

Restriction of Hazardous Substances Directive 

RIN 

SCIP 

SDS 

WPIEI  

Reference Identification Number 

Substance of Concern in Products (database) 

Safety Data Sheet 

Council Working Party on International Environmental Issues 
(Chemicals/Synergies) 

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1 

INTRODUCTION 

The PIC Regulation 

1.1 
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) that bans or severely restricts a chemical in the 
EU in one use category of the Convention (industrial chemicals or pesticides) and which are listed 
in Part 2 of Annex I to 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 EU 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  EU.  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. https://eur-lex.europa.eu/eli/reg/2012/649/oj  

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. https://eur-lex.europa.eu/eli/reg/2008/1272/oj  

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Exclusion of Great Britain (GB) and Northern Ireland (NI) 

1.2 
The  United  Kingdom  left  the  European  Union  at  the  end  of  2020.  Therefore,  the  European 
Commission  decided  not  to  consider  the  United  Kingdom  (GB  and  NI)  for  this  report.  The 
requirement to report applies to Member States. 

The reporting exercise 

1.3 
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 under 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, or the Agency) 

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

This reporting exercise is the third under the PIC Regulation and covers the period 2020-2022. 
As in the previous two reporting exercises, t he questionnaire follows 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 re-
created and updated to improve the user-friendliness of the questionnaire and the clarity of  some 
of  the  questions.  The  online  reporting  questionnaire  was  made  available  to  Member State 
on 28 March 2024, with a deadline for completion of 10 May 2024. All reports were submitted 
by  28 June 2024.  The  Agency  published  its  report  on  the operation of the PIC Regulation4 
for the period 2020-2022 in October 2023. 

The present report is the Synthesis Report (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 2020-2022. 

1.4 

Methodology 

Preparation of the Commission’s report 

1.4.1 
The Commission’s report, provided as an Annex to this report, 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 2020-2022. 

To prepare this report, relevant information was compiled from EUR-Lex, the websites of the 
Rotterdam  Convention  and  the  Agency,  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. https://eur-
lex.europa.eu/eli/dec_impl/2016/770/oj 

4  ECHA (2023) Report on the operation of the Prior Informed Consent (PIC) Regulation. ECHA-23-R-11-EN. 

https://echa.europa.eu/documents/10162/18272234/report_pic_art_22_2023_en.pdf  

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Table 1. List of relevant documents consulted for the Commission Report 

List of relevant documents consulted 

Implementing and delegated acts: 

•  Commission Delegated Regulation (EU) 2019/1701  

•  Commission Delegated Regulation (EU) 2020/1068 

•  Commission Implementing Decision (EU) 2020/2182 and its August 2021 correction 

•  Commission Delegated Regulation (EU) 2022/643 

•  Commission Delegated Regulation (EU) 2023/1656 

Associated report: 

•  Report from the Commission to the European Parliament and to the Council on the exercise of the delegation 

conferred on the Commission pursuant to 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. COM(2023) 448 final 

DNA meeting documents: 

•  Minutes of the DNA meetings that were held in 2020, 2021 and 2022 (respectively, the 35th, 36th, 37th, 38th, 39th, 

and 40th meeting of the DNAs). 

•  Any and all amendments to Annex I of the PIC Regulation as presented at the above meetings. 

•  Any import decisions presented at DNA meetings. 

• 

Submission of notifications to the PIC Secretariat, as presented at the 35th, 36th, 37th, 38th, 39th, and 40th DNA 
meeting.5 

Rotterdam Convention documents: 

•  Documentation relating to EU preparations for/actions arising from relevant Rotterdam Convention Conference 
of the Parties (COP) meetings, specifically CoP10 of 26-30 July 2021 and 6-17 June 2022, CoP11 of 1-12 May 
2023. 

• 

PIC Circulars published by the Rotterdam Convention Secretariat (six were published during 2020-2022, 
Circulars LI to LVI).6 

The Agency’s reports on Article 20 and the Operation of the PIC Regulation: 

•  Report on the exchange of information under the PIC Regulation in 2020-20217 

•  Report on the exchange of information under the PIC Regulation in 2022-20238 

•  Report on the operation of the Prior Informed Consent (PIC) Regulation 20239 

CoP documents 

•  Council Decision (EU) 2022/1024 of 7 April 2022 on the position to be taken on behalf of the EU at CoP1010 

1.4.2 

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 questionnaire was reviewed 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 

________________________ 
5  As but one example, how to implement the (then new) listing of “benzene as a constituent of other substances” in Annex I Part 1 of the 

PIC Regulation was discussed in some of these meetings. 

6  https://www.pic.int/Implementation/PICCircular/tabid/1168/language/en-US/Default.aspx  

7  https://echa.europa.eu/documents/10162/1244645/pic_article_20_report_2020-2021_en.pdf  

8  Selected data supplied as a draft prior to publication. 

9  https://echa.europa.eu/documents/10162/18272234/report_pic_art_22_2023_en.pdf  

10 http://data.europa.eu/eli/dec/2022/1024/oj  

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wording  of  the  questions,  add  clarifications,  definitions  and  guidance  where  needed  etc. 
Increased opportunity was provided for respondents to provide positive and negative feedback 
in response to the same question if necessary. Some changes encouraged consistent wording 
for  common  responses,  whilst  allowing  new  responses  to  be  added.  There  was  also  more 
opportunity to provide focussed additional comments if desired.  

The common reporting format was made available online to Member States on  28 February 
2024, through EU Survey. A guidance document for Member States accompanied the invitation 
email together with contact details of the consultants running the survey available to assist with 
completion if needed. To facilitate Member State reporting, the Agency made data from ePIC 
available to DNAs for the following questions: 

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

by DNA and forwarded to the Agency. 

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

request resubmission or because the notification was rejected. 

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

responses received per year.   

•  Section 7 - Question 43: number of cases where DNA had to decide if no explicit consent 
was required in case of chemicals listed in Part 2 of Annex I to be exported to Organisation 
for Economic Cooperation and Development (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.   

Synthesis of Member States’ reporting 

1.4.3 
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 data received was checked for completeness, adequacy and consistency of logic between 
answers, and clarification was sought from Member States where necessary. 

1.4.4  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  the  Annex  to  this  report,  follows  the  same  structure  as  that  of  the 
Synthesis Report, presenting the key facts and conclusions from each section. 

10 

 
 
   
 
 
2 

2.1 

GOVERNANCE OF THE PIC REGULATION 

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 EU 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  has  one  team  leader  for 
international  chemicals  policy  responsible  for  carrying  out  the Commission’s administrative 
functions  under  PIC.  The  team  leader  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 team leader and a policy officer) nominated to the Chemical Review Committee of 
the Rotterdam Convention (CRC). The Head of Unit is also involved, in particular regarding 
the Conference of the Parties (CoP) where they normally lead the EU delegation and represent 
the EU. In addition, a policy officer from Unit B.2 is involved in the international work and 
colleagues  from  Unit  F.3  (Global  Environmental  Cooperation  &  Multilateralism)  who  are 
responsible for multilateral environmental cooperation, contributed to its 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,  certain  legal 
matters and the technical assistance contracts on implementation of the Rotterdam Convention. 
The staff resources occupied by this work amount to 0.4 FTE11 for the team leader, 0.3 FTE for 
policy  officers/legal  officers,  and  0.1  FTE  for  the  supporting  work,  including  international 
matters  

2.1.2  European Chemicals Agency (ECHA or the Agency) 
The Agency plays a central role in ensuring that the export notification procedure functions 
properly, as well as developing and operating the application to process export notifications and 
the explicit consent given by the importing countries (ePIC). More specifically, the tasks of the 
Agency include: 

•  Registering  the  export  notifications  established  by  the  exporters  and  sent  by  EU DNAs, 
assigning  them  a  Reference  Identification  Number  (RIN),  checking  their completeness 
and  forwarding  them  to  the  DNA  of the importing  country  (Article 8(2)).  

•  Sending a second export notification if the Agency does not receive an acknowledgement 
of  receipt  from  the  authority  in  the  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)).  

________________________ 
11 Full time equivalent. 

11 

 
 
•  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  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
Regulation  (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). The Agency has maintained staffing at the same level as 
compared to the previous period.12 

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

Year 

Number of staff working on PIC 
(FTE)* 

2020 

2021 

8 

8 

8 

2022 
 * The number covers staff in the PIC operations team in Unit A3 (7 FTEs) 
plus 1 FTE in horizontal activities (e.g. HR, finance, IT). 

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, Persistent Organic Pollutants 
(POPs)  Regulation,  the  Biocidal  Products  Regulation  (BPR),  Chemical  Agents  Directive, 
Carcinogens  and  Mutagens  Directive,  and  the  Waste  Framework  Directive  Substance  of 
Concern in  Products  (SCIP)  database, 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  Substance identity check of chemicals added to the PIC Regulation by means of an 
amendment or in cases of substances belonging to groups (following ad-hoc requests 
from companies and Member States), 

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,   

________________________ 
12 Data extracted from ECHA Report on the operation of the Prior Informed Consent (PIC) Regulation 2023, October 2023 ECHA-23-R-11-

EN, https://echa.europa.eu/documents/10162/18272234/report_pic_art_22_2023_en.pdf  

12 

 
 
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  Drafting decision guidance documents (DGD) for the Chemical Review Committee, 

in support to the Commission (since 2022), 

o  Providing  support 

to  stakeholders  (including 

through 

publication/update  of  various  manuals,  guidelines  and 
communication actions, the Agency Newsletter, social media, etc.).  

the  Helpdesk, 

the 
factsheets,  and 

•  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); 
•  Planning,  data  mining  and  reporting  (i.e.  optimise  the  planning  and  reporting  of the 

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

•  Legal advice; and 
•  Human resources and finance. 

The number of export notifications processed by the Agency decreased over the whole reporting 
period. The continuous rising trend in the number of export notifications received and processed 
annually  that  was  observed  during  the  previous  reporting  periods,  was  reversed  during  the 
period 2020-2022; therefore, the previous estimate of a ~10% yearly increase was not followed. 

The figures in Table 3 below for 2020 include export notifications submitted from the United 
Kingdom (733 validated for 2020), whereas 2021 and 2022 refer to submissions after BREXIT 
- i.e. not including export notifications from the United Kingdom (specifically Great Britain) to 
other non-EU countries. However, the overall processing-related workload of the Agency’s PIC 
Team remained high, since other processing and related tasks have increased in balance over 
the same period. 

Table 3. Number of export notifications predicted versus processed by the Agency13 

Estimated No. of notifications (based on 10% year on year rise) 

Actual no. of notifications processed 

2020 

12 000 

11 971 

2021 

13 200 

10 699 

2022 

14 500 

10 072 

The number of export notifications received from other countries increased over the period as 
shown in Table 4 due to the notifications received from the United Kingdom (Great Britain) for 
2021 and 2022. Over 400 notifications were received and processed annually from the UK(GB) 
for imports of PIC chemicals into the EU during both of these years.14  

Table 4. Number of export notifications received from other countries processed by the 

Agency13 

Number of export notifications processed 

2020 

381 

2021 

674 

2022 

811 

________________________ 
13 Data extracted from ECHA Report on the operation of the Prior Informed Consent (PIC) Regulation 2023, October 2023 ECHA-23-R-11-

EN, https://echa.europa.eu/documents/10162/18272234/report_pic_art_22_2023_en.pdf 

14 More details can be found here: https://echa.europa.eu/information-on-chemicals/pic/import-notifications 

13 

 
 
 
 
There has been a notable increase in the number of requests for technical / regulatory support 
from the agency as shown in Table 5. 

Table 5. Number of requests for technical/regulatory support from the Agency13 

Number of requests for technical / regulatory support 

2020 

3 450 

2021 

3 550 

2022 

3 800 

Most chemicals that were added to the list of chemicals subject to the PIC procedures (Annex 
I)  during  the  reporting  period  (through  amending  regulations  (EU)  2020/1068  and  (EU) 
2022/643) require an explicit consent from the authorities in the country of destination before 
the export can take place. This leads to the need for additional stakeholder support towards both 
the  EU  Member  States’  DNAs,  and  authorities  in  non-EU  importing  countries.  Follow-up 
enquiries from companies on the status of their notifications also naturally increase since such 
exports are often not allowed at the time when notifications are validated. Furthermore, queries 
increased because new types of entries were introduced in the reporting period that are more 
complex to implement. These entries were: 

•  “Benzene as a constituent of other substances in concentrations equal to, or greater than 
0,1% by weight”. This is the first “substance in substances” type entry subject to the 
PIC Regulation requirements,  

•  Substances previously in part 1 (only) of Annex I and added to part 2, and 
•  Entries for chemicals (e.g. thiram, thiamethoxam) that are exported in treated seeds. 

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 - 80% of the total yearly submissions), the Agency reported hiring interim staff for 
several months every year during the peak period. This situation was similar in the previous 
reporting period. Due to the timing of entry into application of annual amendments to Annex I 
in the course of the export year (e.g. July), an additional (mini) peak in the workload was always 
expected immediately after the publication of the amendment and triggers challenges in terms 
of availability of resources and planning.   

The high and increasing number of submissions led the Agency to continue investing human 
and financial resources in the enhancement and maintenance of the ePIC application, further 
improving  the  existing  features  and  more  generally  the  Agency’s  processes  and  ways  of 
working in implementing the PIC Regulation.  

The Agency recommended that further enhancements to the application should be considered 
to  support  all  actors  to  cope  with  a  high  workload  and  to  meet  their  legal  obligations15.  IT 
development is nevertheless resource-demanding as the Agency’s PIC Team has to be involved 
in  specifying  the  requirements  for  improvements,  supporting  the  developers  in  the  analysis 
phase, as well as in the testing and roll-out activities. More generally, it should be noted that 
since its initial certification under the ISO 9001 Standard in 2015, the Agency’s implementation 
of the PIC Regulation  has regularly been  audited successfully, which confirms  that the PIC 
processes  and  the  use  of  resources  are  under  control,  optimised  and  subject  to  continuous 
improvement. 

An  increased  interest  of  media  and  non-government  organisations  (NGOs)  on  PIC  data  in 
general, and the topic of the export of EU banned substances in particular led to a substantial 
number of Access To Document (ATD) requests on PIC data during the reporting period (21 in 

________________________ 
15 Concrete suggestions provided under question 43 reported by ECHA, Report on the operation of the Prior Informed Consent (PIC) 

Regulation 2023, October 2023 ECHA-23-R-11-EN 

14 

 
 
 
total), some of them being very large and complex in scope. The listing of neonicotinoids to 
Annex I in 2020 intensified the already high public interest in exports of PIC substances (in 
particular pesticides) leading to an increase in the number and complexity of ATD requests. 
Should  the  Agency  continue  to  receive  large  numbers  of  PIC  ATD  requests,  additional 
resources would be needed, or alternatively, effective solutions should be identified to reduce 
the number of such ATD requests  

The introduction of a ban on the production for export of hazardous chemicals that are banned 
in  the  EU  could  however  lead  to  a  decrease  in  the  current  pressure  on  the  Agency’s  PIC 
resources, hence clarity in the scope and timelines for this initiative under the Chemical Strategy 
for Sustainability may confirm this resource need or not. 

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 the Agency under the PIC 
Regulation and developed several options for a fee system. The options included an assessment 
of  the  financial  and  technical  feasibility  and  appropriateness  of  the  options  for  the  different 
stakeholder groups impacted (the Agency, 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. Taking into account the results of the study and the consultation of the Agency and 
Member States, the Commission decided not to submit a proposal.  

2.1.3  DNAs 
Member States play a major role in the application, implementation, and enforcement of the 
PIC Regulation. They must designate one or several authorities to carry out the administrative 
functions required by the PIC Regulation (Article 4). A total  of  36  authorities  have  been 
designated  by  Member  States.  Article  18  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 covering four areas 
of  activity:  administrative  tasks,  enforcement,  monitoring  and  reporting,  and  exchange  of 
information16. 

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)). 

________________________ 
16 Adapted from: ECHA, Guidance for implementation of Regulation (EU) No 649/2012 concerning the export and import of hazardous 

chemicals, version 1.1, 2015. https://echa.europa.eu/guidance-documents/guidance-on-pic    

15 

 
 
• 

•  Forward export notifications received from non-EU 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. 

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). 

Table 6. Distribution of responsibilities across DNAs in Member States with more than 

one DNA 

Member State 

Distribution of responsibilities 

Denmark 

Danish Environmental Protection Agency (Danish EPA) carries out general PIC work;  

Danish Ministry of Environment is the connection between PIC and the Rotterdam Convention 

16 

 
 
Member State 

Germany17 

Distribution of responsibilities 

Federal Institute for Occupational Safety and Health (BAuA) is responsible for the national 
administrative procedures in relation to Regulation (EU) No. 649/2012;  

Federal Office for Consumer Protection and Food Safety (BVL) is responsibilities relating to the 
Rotterdam Convention in relation to pesticides 

Ireland 

Health and Safety Authority (HSA) is responsible for industrial chemicals;  

Greece 

Italy 

Latvia 

Hungary 

Netherlands 

Department of Agriculture, Food and the Marine (DAFM) is responsible for the Biocidal Products 
Regulation and the Plant Protection Products Regulation;  

Revenue Commissioners are responsible in respect of Article 18 of the PIC Regulation 

Independent Authority for Public Revenue - DG of the General Chemical State Laboratory-
Directorate of Energy, Industrial and Chemical Products-'Section B' is responsible for industrial 
chemicals;  

Hellenic Ministry of Rural Development and Food - General Directorate of Agriculture - Directorate 
of Plant Produce Protection - Department of Plant Protection Products and Biocides Department is 
responsible for Pesticides 

Ministry of Health (ex DG Health prevention) manages the implementation of PIC, supports 
companies, manages notifications, manages explicit consent requests and cooperates with customs 
for enforcement activities. The Ministry of Health should coordinate with the other two DNAs but 
this task was not applied because during the period 2020-2022 because there was lack of dedicated 
human resources in these ministries;  

Ministry of the Environment and Energetic Safety does not perform any activities in order to 
implement the PIC regulation;  

Ministry of Enterprises and 'Made in Italy' does not perform any activities in order to implement the 
PIC Regulation 

State Limited Liability Company "Latvian Environment, Geology and Meteorology Centre" 
(LEGMC), for industrial chemicals;  

State Plant Protection Service (SPPS), for pesticides 

National Center for Public Health and Pharmacy (NCPHP) is responsible for industrial chemicals 
and other pesticides;  

National Food Chain Safety Office is responsible for pesticides used as plant protection products 

Ministry of Infrastructure and Water Management: over all responsible for the policy area and 
politically responsible for the correct implementation/enforcement of the regulation. The Human 
Environment and Transport Inspectorate, which is the supervising authority of the Ministry, is 
tasked with supervision;  

Tax and Customs Administration: the 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. Documentary checks are done by customs at the border (on the basis of 
export notifications) 

Slovakia 

Ministry of Economy is responsible for industrial chemicals and pesticides;  

Ministry of Agriculture and Rural Development is responsible for pesticides 

Most Member States (18) had only 1 DNA, while 9 had 2 or 3. DNAs were 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 
were designated as competent authorities. Since the previous reporting exercise, one Member 
State had designated a new DNA (DK). 

In 5 Member States (out of nine) that had more than one DNA, responsibilities were divided 
between 1 DNA responsible for industrial chemicals and one DNA responsible for pesticides. 
In other cases, there was one main DNA responsible for the implementation of the Regulation 
(and in some cases delegated tasks to another authority). Table 6 above provides information 
on the distribution of responsibilities in Member States with several DNAs. 

________________________ 
17 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.    

17 

 
 
PIC  DNAs  in  25  Member  States  were  involved  in  the  implementation  of  other  EU  or 
international chemicals legislation, convention, or other instruments as illustrated in Figure 1. 
19 DNAs were also involved in supporting 14 other legal requirements.18 

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

DNAs  reported  levels  of  resources  dedicated  to  the  implementation  of  the  PIC  Regulation 
ranging from 0.05 to 3.25 FTEs (see Figure 2). In the previous period the maximum resources 
dedicated to PIC were 2 FTE, whereas in this period 3 Member States indicated effort in excess 
of 2 FTE. Most Member States devoted much lower resources with 10 reporting less than 0.5 
FTE, and a further 13 less than 1.5 FTE – however there were periodic fluctuations during the 
year.  

Figure 2: Q8. Please specify the human resources (in full-time equivalent-FTE) in 
the DNA(s) working on the implementation of the PIC Regulation19 

________________________ 
18 Support regarding Drug Precursors, F-gas, Global Framework on Chemicals (SAICM), Ozone Depleting substances (ODS), or Restriction 

of Hazardous Substances (RoHS) was reported by two Member States.  

  Support was provided regarding Chemical Weapons Convention (CWC), Emissions, Explosive Precursors, Genetically Modified 

Organisms (GMO), Good Laboratory Practice (GLP), Greenhouse Gases (GHG), Tobacco, Transboundary impact of industrial accidents 
(TEIA), or Volatile Organic Compounds (VOC) by one Member State.  

  Note that the Member States concerned in each case may not be the same. 

19 Not all Member States collect data on how effort expended on PIC is divided between multiple personnel some of whom work on other 

requirements (not just the PIC Regulation). As such the data was indicative in some cases. 

18 

 
 
 
 
 
2.2 

Coordination between the Commission, the Agency and DNAs 

2.2.1  Coordination between the Commission and the DNAs 
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 regarded:  

•  Article  14(5):  Advice  and  assistance  to  importing  parties  upon  request  -  4  Member 

States;   

•  Article 11(7): Evaluation of the need to propose measures at EU level - 3 Member States; 
•  Article 11(8): Procedure in case a Member State takes national final regulatory action 

- 3 Member States; 

•  Article  18(1):  Commission,  Member  State,  ECHA  obligation  to  monitor  exporter 
compliance - 3 Member States. This was one of the main areas of improvement cited in 
the previous period. 

Either 1 or 2 Member States also gave the following as areas for improvement: 

•  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 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 20: Exchange of information; 
•  Article 21: Technical assistance; 
•  Article 23: Updating annexes. This was the other main area of improvement mentioned 

by DNAs in the previous period. 

Over half of the DNAs (14) replied that none of the proposed areas of coordination (listed in 
the question20) need to be improved.  

Further ad hoc comments on improvements were provided by Member States as follows: 

•  Two  Member  States  mentioned  that  it  would  be  helpful  if  the  documents  needed  for 
DNA meetings were provided earlier in order to enable them to prepare as currently this 
is challenging. One also mentioned that the minutes from the previous meeting arrive 
only a few days before the next meeting. The other asked that decisions taken during 
DNA meetings be communicated shortly afterwards.21 

________________________ 
20 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 EU 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 EU 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.    

21 This Member State gave as examples 1) that the Annex listing articles examples is still not available and they are awaiting feedback on 

their comments on this issue, and 2) they are awaiting the Commission's position on treated seeds notifications. 

19 

 
 
•  Coordination could be improved when requesting access to information. 
•  Changes  to  the  annexes  of  the  PIC  regulation  should  only  enter  into  force  on  the  1st 
January  of  each  year  (and  not  earlier  or  later).  While  chapter  3  of  each  SDS 
(‘Composition/information  on  ingredients’)  for  mixtures  is  not  stored  in  ePIC,  it  is 
completely uncertain which cases fall under the amendment and RINs therefore have to 
be made inactive at the date of entering into force This is an ongoing issue which has yet 
to be resolved satisfactorily. 

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 and on replies to requests 
for explicit consent received from other Parties. 

2.2.2  Coordination between the Agency and the DNAs 
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, helpfulness and high quality 
– quick responses to questions, informal exchanges when needed, support on specific issues 
when raised, information about updated tools or guidance.   

The main area of improvement according to DNAs regarded:  

•  Article  6(1)(c):  assistance  and  technical  and  scientific  guidance  and  tools  for  the 
industry – 5 Member States. This is an area of improvement which was not flagged in 
the previous reporting exercise. Two specific proposals were provided in this area 1) 
CN  numbers  for  all  chemicals  subject  to  PIC  to  be  added  against  each  entry  in  the 
Agency's public online database22, and 2) Multilingual ePIC user manuals for industry 
should be updated according to updates made in the English language version of the 
manual. 

Either 1 or 2 Member States also mentioned the following as areas for improvement as in the 
previous period: 

•  Article 8(7): Additional information to be provided on request concerning the exported 

chemical; 

•  Article 21: Technical assistance; 
•  Article 23: Updating annexes. 

and four further areas not mentioned in the previous period: 

•  Article  11(6):  Member  State  obligation  to  assist  the  Commission  in  compiling 

information; 

•  Article 11(7): Evaluation of the need to propose measures at EU level; 
•  Article  18(1):  Commission,  Member  State,  ECHA  obligation  to  monitor  exporter 
compliance. In particular, it could be useful to evaluate involvement of DG TAXUD to 
support the identification of the appropriate CN code for mixtures subject to the PIC 
regulation in order to facilitate custom activities.  

•  Article 20: Exchange of information. 

________________________ 
22 https://echa.europa.eu/information-on-chemicals/pic/chemicals  

20 

 
 
Over half of the DNAs (17) replied that none of the proposed areas of coordination (listed in 
the question23) need to be improved. 

The Agency reported that they and the DNAs continued to work together in a collaborative, 
efficient and friendly manner and this is often acknowledged by the DNAs at DNA meetings. 
In  addition  to  day-to-day  exchanges  and  to  foster  the  collaboration,  ad  hoc  supplementary 
support was provided to the DNAs over the reporting period. This included: 

•  Organising  online  training  sessions  on  the  new  functionalities  of  the  enhanced 
messaging  module  in  ePIC  (8  June  2021),  and  on  explicit  consent  management  (17 
November 2021);  

•  Providing  detailed  practical  guidelines  on  how  to  request  consent  responses  for  the 
export notifications referring to substances that starting with 1 July 2022 moved from 
part  1  to  part  2  of  Annex  I.  (The  Commission  delegated  Regulation  (EU)  2022/643 
amending Annexes I and V to the PIC Regulation was published on 20 April 2022. The 
Agency emailed guidelines to the DNAs on 21 April 2022); 

•  To support the DNAs in the preparations and submission of the annual reports according 
to Article 10 of the PIC Regulation, the Agency prepared a checklist that included the 
main steps for verification of the industry reports, tips to identify errors, and actions for 
submitting the national reports. (This was provided to the DNAs in August 2022 and 
then  as  attachment  to  the  periodic  reminders  for  submitting  their  annual  national 
reports); 

•  Organising a workshop with the Finnish DNA and Customs to share experiences with 
the PIC Regulation processes from different perspectives and identify potential actions 
(4 October 2022). 

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. Both of these areas of improvements were mentioned in the previous Agency’s reports 
for the periods 2014-2016, and 2017-2020. 

2.2.3  Coordination between the Commission and the Agency 
The Commission considered cooperation with the Agency to be satisfactory. The Commission 
and the Agency cooperated closely in the implementation of the PIC Regulation. There were 
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 participated 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 waivers24). For cooperation with non-EU countries and 
the  Secretariat  of  the  Rotterdam  Convention,  the  Commission  and  the  Agency  closely 
coordinated their activities to ensure that the most appropriate and effective assistance  were 
provided, and that resources were used efficiently. 

________________________ 
23 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 EU level; Article 13(6) — evaluation of the need to propose 
measures at EU level; Article 20 — exchange of information; Article 21 — technical assistance; Article 23 — updating annexes.    

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

21 

 
 
As  in  the  previous  reporting  period,  the  Agency  indicated  that  the  coordination  with  the 
Commission is generally satisfactory. In addition to the day-to-day email exchanges between 
the  Agency’s  PIC  Operations  Team  and 
the  continuing  regular 
teleconferences (every six weeks on average), established in the previous period, to discuss the 
Agency’s PIC-related tasks/activities, and in particular when the involvement of other Agency 
expert colleagues is needed, had contributed to increasing the predictability and planning of 
work. 

the  Commission, 

The overall efficiency of waiver management had improved. The number of cases leading to a 
revision of the initial decision (mentioned in the two past reports) decreased. Certain cases were 
still clarified through day-to-day exchange between the Agency and the Commission since the 
Agency often has a better visibility on the communications of ongoing clarifications regarding 
the consent responses. 

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

•  Technical  preparation  of  meetings  (e.g.  DNA  meetings,  Chemical  Review 
Committee,  Conference  of  the  Parties  to  the  Rotterdam  Convention).  In  particular 
regarding the biannual DNA meetings, the documents were often sent to the Agency for 
checking/drafting  with  short  response  deadlines.  This  made  it  challenging  for  the 
Agency  to  produce  good  quality  documentation  at  the  desired  time.  The  Agency 
considered more advanced planning including a stronger collaboration in identification 
of  agenda  items,  preparation  of  the  discussions,  and  development  of  the  related 
supporting meeting documents. 

•  Article 23 of Regulation (EU) No 649/2012 on updating annexes. Early involvement 
of the Agency in changes to Annexes I and V was invaluable. If amendments to annexes 
entered into application on 1st January only, it would minimise the administrative burden 
on all parties to the process. 

Such  timing  would  improve  the  predictability  and  better  planning  not  only  for  the 
Agency,  but  also  for  the  duty  holders  to  prepare  for  their  exports  and  the  related 
notification obligations. In addition, a small window between the publication and the 
entry  into  application  tended  to  create  pressure  to  have  the  export  notifications  and 
explicit consents in place within a very short period of time, in cases where companies 
planned to continue the exports after the date of entry into application of the regulation. 
As an example, in 2020 there were only 42 calendar days between the publication and 
entry into application (published on 21 July 2020 and entry into application 1 September 
2020). 

Clarity  as  to  the  reasons  and  regulatory  basis  for  the  listing  of  entries  to  the  PIC 
Regulation is of prime importance for all the actors involved. This information is the 
basis  for  the  legal  texts  developed  by  the  Agency  and  made  available  in  ePIC  for 
exporters to fill in the Section 6.1 of their export notifications. Such a clear and explicit 
mapping of the reasons and regulatory basis for the listing of a substance at the time of 
its  inclusion  into  Annex  I,  would  support  the  establishment  of  a  more  systematic 
monitoring of the regulatory status within EU of the substance after its listing. 

Note that Article 23 was also mentioned as an area needing attention by 2 Member States 
(see Section 2.2.2). Further clarification of what is desired would need to be sought from 
DNA concerned.  

•  The timing of replies with regards to the day-to-day exchanges between the Agency 
and  the  Commission.  Whereas  some  delays  were  understandable  for  certain  policy 

22 

 
 
issues  (which  are  often  complex  in  nature  and  may  require  an  involvement  of  other 
Commission  services),  they  could  create  challenges  on  operational  issues  which,  for 
example,  concern  a  specific  export.  In  such  cases,  the  Agency  was  often  put  under 
pressure  by  the  exporter/exporter’s  DNA.  This  was  noted  as  an  area  in  need  of 
improvement for the three previous periods. 

The EU as a Party to the Rotterdam Convention 

2.3 
The Commission, as the EU DNA, is the main interface with the Secretariat of the Convention. 
In particular, the Commission is responsible for: 

•  Representing the EU to the Rotterdam Convention. 
•  Coordinating  the  EU  input  on  all  technical  issues  related  to  the  Convention,  the 

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

•  Submitting  to  the  Secretariat  relevant  FRA  notifications  concerning  chemicals 

qualifying for PIC notification. 

•  Transmission of information on other FRA involving chemicals not qualifying for PIC 

notification. 

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

procedure. 

•  Exchange of information with the Secretariat in general. 

The  Member  States,  as  Parties  to  the  Convention,  also  participate  in  the  CoP  and  in  the 
definition of the EU position on matters discussed. They nominate experts who serve in the 
CRC and the Compliance Committee and contribute to other activities under the Convention. 
Some  DNAs  also participate in technical assistance activities under the Convention, to which 
the Agency also contributes. 

2.3.1  Coordination of EU input to the Conferences of the Parties (CoP) 
During the reporting period, the Commission represented the EU at the 10th CoP, which took 
place from 26 to 30 July 2021 (online segment which dealt with operational matters only), and 
from 6 to 17 June 2022 (face-to-face segment which dealt with technical and financial matters). 
Preparation  for  the  11th  CoP  which  took  place  from  1  to  12  May  2023  also  occurred  so  is 
reported here. 

CoP-1025  
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 a: 

to 

•  Proposal for a Council Decision establishing the position to be adopted on behalf of the 
European Union within the Conference of the Parties as regards amendments of Annex 
to  add 
III 
decabromodiphenyl ether (decaBDE) and perfluorooctanoic acid (PFOA), its salts and 
PFOA related compounds to Annex III. This proposal was adopted and submitted to the 
Council on 20 April 2021. 

the  Rotterdam  Convention.  This  concerned 

the  proposal 

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 

________________________ 
25 https://www.pic.int/TheConvention/ConferenceoftheParties/Meetings/COP10/tabid/8398/language/en-US/Default.aspx  

23 

 
 
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-10, the Commission presented the outcomes of the CoP to DNAs at the 40th DNA 
meeting on 20 October 2022. As regards listing of additional chemicals in Annex III, out of 7 
chemicals only 2 had been listed; decabromodiphenyl ether (decaBDE) and perfluorooctanoic 
acid (PFOA), its salts and related compounds. 

CoP-1126 
In preparation for the CoP, which occurred after the present reporting period, the Commission 
prepared and consulted with the Member States on the position of the EU on matters discussed 
at the meeting concerning: 

Two  new  candidates  for  listing  in  Annex  III  that  would  be  on  the  agenda,  based  on  the 
recommendation of the CRC - iprodione and terbufos. The position to be taken on behalf of the 
EU at the COP as regards their listing would be laid down in a Council Decision, which would 
be based on a Commission proposal. The EU and its Member States position on all other agenda 
items that will be addressed at the CoP would be discussed in WPIEI and laid down in an EU-
MS position paper. 

2.3.2 

Participation in committees and expert groups  

Chemical review committee (CRC) 
During  the  reporting  period,  5  or  6  EU  Member  States  had  nominated  experts  to participate 
in  the  16th,  17th  and  18th  meetings  of  the  CRC  (Table 7).  

Table 7. EU Members of the CRC during the reporting period27 

CRC meetings  

EU Members of the CRC 

CRC-16, September 202028 

Experts nominated by Belgium, Latvia, Malta, Austria, Poland, Finland 

CRC-17, September 202129 

Experts nominated by Belgium, Latvia, Malta, Austria, Poland, Finland 

CRC-18, September 202230 

Experts nominated by Belgium, Germany, Latvia, Netherlands, Austria 

Due to the Covid-19 pandemic, the 16th meeting and 17th meeting of CRC were held online in 
2020 and 2021 respectively.  

At the 16th meeting, the CRC agreed to recommend that the CoP list PFOA, its salts and PFOA-
related  compounds  in  Annex  III  to  the  Convention.  The  CRC  also  clarified  the  decision 
guidance  document  (DGD)  on  decaBDE,  which  accompanies  the  recommendation  that 
decaBDE be listed in Annex III. 

CRC-17 took place 20-24 September 2021, in between the CoP-10 online meeting and the face-
to-face part of CoP-10 which took place in 2022. As outcome of this meeting, the Committee 
recommended listing of iprodione and terbufos in Annex III to the Convention.  

________________________ 
26 https://www.pic.int/TheConvention/ConferenceoftheParties/Meetings/COP11/tabid/9312/language/en-US/Default.aspx  

27 UNEP/FAO/RC/CRC.18/INF/3 Information on the rotation of the membership of the Chemical Review Committee, 

https://www.pic.int/TheConvention/ChemicalReviewCommittee/Meetings/CRC18/Overview/tabid/9036/language/en-US/Default.aspx  

28 UNEP/FAO/RC/CRC.16/6 Report of the Chemical Review Committee on the work of its sixteenth meeting, 

https://www.pic.int/TheConvention/ChemicalReviewCommittee/Meetings/CRC16/Overview/tabid/8437/language/en-US/Default.aspx    

29 UNEP/FAO/RC/CRC.17/10 Report of the Chemical Review Committee on the work of its seventeenth meeting, 

https://www.pic.int/TheConvention/ChemicalReviewCommittee/Meetings/CRC17/Overview/tabid/8605/language/en-US/Default.aspx   

30 UNEP/FAO/RC/CRC.18/15 Report of the Chemical Review Committee on the work of its eighteenth meeting,  

https://www.pic.int/TheConvention/ChemicalReviewCommittee/Meetings/CRC18/Overview/tabid/9036/language/en-US/Default.aspx  

24 

 
 
CRC-18 took place 19-23 September 2022 and adopted decisions to recommend the listing of 
paraquat and methyl bromide in Annex III. 

Intersessional work between CRC meetings  
1. 
CRC work between CRC-15 and CRC-16: 

A task group was formed on PFOA, its salts and PFOA-related compounds to undertake an initial 
review of the new notification and supporting documentation and prepare an analysis as to whether 
and how the notification met the criteria set out in Annex II to the Convention. All committee 
members participated.31 A revised draft decision guidance document arose from discussions in the 
16th CRC meeting ready for discussion at the tenth meeting of the Conference of the Parties. 

2. 

CRC work between CRC-16 and CRC-17: 

Intersessional  task  groups  worked  on  review  of  notifications  of  final  regulatory  action  for  the 
following chemicals, producing draft task group reports32 33: 

•  Carbaryl 
•  Chlorfenvinphos 
•  Decabromodiphenyl ether (BDE-209) present in commercial decabromodiphenyl ether 
• 
Iprodione 
•  Methidathion 
•  Methyl parathion 
•  Terbufos 
•  Thiodicarb. 

3.  

CRC work between CRC-17 and CRC-18:34 

Draft decision guidance documents were prepared for iprodione and terbufos. Notifications of final 
regulatory action were reviewed for carbaryl, chlorfenvinphos, methidathion, methyl parathion and 
thiodicarb  ongoing  from  intersessional  work  from  CRC-16  to  17.  In  addition,  reviews  of 
notifications of final regulatory action for substances were also carried out for the following, which 
were deferred for review until after CRC-17: 

•  Amitrole 
•  Carbon Tetrachloride 
•  Methyl Bromide 
•  Mirex 
•  Paraquat. 

Financial contributions to the Rotterdam Convention 

2.3.3 
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 8). 

________________________ 
31 From part VI section A paragraph 55 of UNEP/FAO/RC/CRC.16/6 Report of the Chemical Review Committee on the work of its sixteenth 

meeting, https://www.pic.int/TheConvention/ChemicalReviewCommittee/Meetings/CRC16/Overview/tabid/8437/language/en-
US/Default.aspx 

32 UNEP/FAO/RC/CRC.17/10 agenda 

https://www.pic.int/TheConvention/ChemicalReviewCommittee/Meetings/CRC17/Overview/tabid/8605/language/en-US/Default.aspx  

33 Part V Section B, paragraph 43 of UNEP/FAO/RC/CRC.18/15.  

34 Part II Section B paragraph 15 agenda item 5 of UNEP/FAO/RC/CRC.18/15: https://www.pic.int/Default.aspx?tabid=9197   

25 

 
 
Table 8. Financial contributions from the EU to the Rotterdam Convention’s Trust 

Fund and Special Voluntary Trust Fund (USD) 

Year 

EU Contribution to Trust Fund35 

EU contribution to special voluntary 
trust fund36 

2020 

2021 

2022 

79 417 

80 440 

78 738 

617 131 

0 

0 

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.  No  Member  States  contributed  to  the  Special  Voluntary  Trust  Fund  during  the 
present  period  (Table  9).  Contributions  for  the  years  2017  to  2019  were  not  reported  in  the 
previous report (2017-2019) so are included here for completeness. 

Table 9. Member States’ contributions to the Special Voluntary Trust Fund (USD) 37  

Member 
State 

2017 

2018 

2019 

2020 

2021 

2022 

Germany 

44 574 

70 514 

France 

0 

113 636 

Netherlands 

41 116 

39 773 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

________________________ 
35 The contributions published on the Convention website are calculated in US dollars - USD.  

36 Commitments in accordance with the agreement concluded with the Secretariat of the Convention in the respective year. 

37 From the Rotterdam Convention website, amounts converted from USD to EUR at January 2022 rates between 2014 - 2018.  For 2022, the 

values are the actual Euro value paid as given in status of contributions website, 12/31/2022. 
https://www.pic.int/TheConvention/FinanceBudget/SpecialVoluntaryTrustFundRC/2022SpecialVoluntaryTrustFundRC/tabid/9169/langua
ge/en-US/Default.aspx  

26 

 
 
UPDATES OF ANNEX I AND ANNEX V TO THE PIC REGULATION 

3 
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  acts.  This 
consultation is carried out by presenting the drafts at the DNA meetings in order to ensure that 
all  Member  State  experts  have  the  opportunity  to  comment.  Draft  delegated  acts  are  also 
submitted via the public feedback mechanism to the general public to give them the opportunity 
to comment. After adoption, the delegated acts are scrutinised by the European Parliament and 
the Council to ensure that the Commission does not exceed its powers. 

Update of Annex I   

3.1 
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 an active substance under the PPPR; 
•  Decision not to approve 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 2020 to 2022, two Delegated Regulations amending Annex I were 
adopted: 

•  Commission Delegated Regulation (EU) 2020/106838; 
•  Commission Delegated Regulation (EU) 2022/64339. 

In  Commission  Delegated  Regulation  (EU)  2022/643,  there  were  sufficient  alterations  to 
existing  entries that the  whole of  Annex  I was substituted with  a replacement annex. These 
alterations were mainly necessary to update the customs codes provided in Annex I. 

Substances added to Annex 1 
Of the 48 substances added to Annex I during the reporting period: 

•  35  substances  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 (PPPR), which represented a  ban  or  severe  restriction 
in  the  use  category  ‘pesticide’,  as  shown  in  Table  2 (basis for inclusion is noted as 
‘PPPR’).   

•  1 substance was added to Parts 1 and 2 of Annex I following its non-approval for use in 

biocidal products in accordance with the BPR Regulation (EU) No. 528/2012. 

•  6 were added to Parts 1 and 2 of Annex I on the basis of the REACH Regulation because 
they were severely restricted or banned as industrial chemicals – 3 for public use, 3 for 
professional use.  

________________________ 
38 Commission Delegated Regulation (EU) 2020/1068 of 15 May 2020 amending Annexes I and V to Regulation (EU) No 649/2012 of the 

European Parliament and of the Council concerning the export and import of hazardous chemicals, (OJ L 234, 21.7.2020, p. 1–7). 
http://data.europa.eu/eli/reg_del/2020/1068/oj  

39 Commission Delegated Regulation (EU) 2022/643 of 10 February 2022 amending Regulation (EU) No 649/2012 of the European 

Parliament and of the Council as regards the listing of pesticides, industrial chemicals, persistent organic pollutants and mercury and an 
update of customs codes, (OJ L 118, 20.4.2022, p. 14–54). https://eur-lex.europa.eu/eli/reg_del/2022/643/oj   

27 

 
 
•  2  were  added  to  Parts  1  and  2  of  Annex  I  because  they  were  severely  restricted  as 

industrial chemicals under the POPs Regulation (EU) 2019/1021.  

•  Finally, 4 were included in Part 3 of Annex I following their inclusion in Annex III to 

the Rotterdam Convention (RC).  

Table 10. Chemicals added to Annex 1 during the reporting period 

Delegated Act 

Chemical name 

CAS number 

Amendment 
of Annex I 

Basis for 
inclusion 

Commission 
Delegated 
Regulation (EU) 
2020/1068 of 15 
May 2020  

Chlorothalonil 

Chlorpropham 

Clothianidin 

Desmedipham 

Dimethoate 

1897-45-6 

Parts 1 and 2 

PPPR 

101-21-3 

Parts 1 and 2 

PPPR 

210880-92-5 

Parts 1 and 2 

PPPR 

13684-56-5 

Parts 1 and 2 

PPPR 

60-51-5 

2764-72-9 

85-00-7 

Parts 1 and 2 

PPPR 

Parts 1 and 2 

PPPR 

13194-48-4 

Parts 1 and 2 

PPPR 

161326-34-7 

Parts 1 and 2 

PPPR 

96525-23-4 

Parts 1 and 2 

PPPR 

Parts 1 and 2 

PPPR 

Part 3 

RC 

51276-47-2  

77182-82-2 

25637-99-4,  

3194-55-6,  

134237-50-6,  

134237-51-7,  

134237-52-8  

and others 

138261-41-3 

Part 1 

PPPR 

144651-06-9 

Parts 1 and 2 

PPPR 

298-02-2 

Parts 1 and 3 

RC 

60207-90-1 

Part 1 

PPPR 

12071-83-9  

9016-72-2 

Parts 1 and 2 

PPPR 

123312-89-0 

Parts 1 and 2 

PPPR 

124495-18-7 

Parts 1 and 2 

PPPR 

153719-23-4 

Parts 1 and 2 

PPPR 

137-26-8 

121-14-2 

Parts 1 and 2 

PPPR 

Parts 1 and 2 

REACH 

Diquat, including diquat dibromide 

Ethoprophos 

Fenamidone 

Flurtamone 

Glufosinate, including glufosinate-
ammonium 

Hexabromocyclododecane 

Imidacloprid 

Oxasulfuron 

Phorate 

Propiconazole 

Propineb 

Pymetrozine 

Quinoxyfen 

Thiamethoxam 

Thiram 

2,4-Dinitrotoluene (2,4-DNT) 

Commission 
Delegated 
Regulation (EU) 
2022/643 of 10 
February 2022 

4,4'-Diaminodiphenylmethane (MDA) 

101-77-9 

Parts 1 and 2 

REACH 

Azinphos-ethyl 

Benalaxyl 

2642-71-9 

Part 2 

PPPR 

71626-11-4 

Parts 1 and 2 

PPPR 

28 

 
 
Delegated Act 

Chemical name 

CAS number 

Amendment 
of Annex I 

Basis for 
inclusion 

71-43-2 

Part 1 

REACH 

Benzene as a constituent of other substances 
in concentrations equal to, or greater than 
0.1% by weight. Except motor fuels subject 
to Directive 98/70/EC of the European 
Parliament and of the Council of 13 October 
1998 relating to the quality of petrol and 
diesel fuels (OJ L 350, 28.12.1998, p. 58). 
Part of EU combined nomenclature (CN) 
code 2707 10 00 

Beta-cyfluthrin 

Bifenthrin 

1820573-27-0 

Parts 1 and 2 

PPPR 

82657-04-3 

Parts 1 and 2 

PPPR 

Bis(pentabromophenyl) ether (decaBDE) 

1163-19-5 

Parts 1 and 2 

POP 

Bromoxynil 

Cadmium and its compounds 

Chlorpyrifos 

Chlorpyrifos-methyl 

Empenthrin 

Epoxiconazole 

Ferbam 

Fanamiphos 

Hexazinone 

Lead (Pb) and its compounds 

Mancozeb 

Mecoprop 

Mercury 

Methiocarb 

Methomyl 

1689-84-5 

3861-41-4 

56634-95-8 

1689-99-2 

7440-43-9 

and others 

2921-88-2 

5598-13-0 

Parts 1 and 2 

PPPR 

Part 2 

REACH 

Part 2 

PPPR 

Parts 1 and 2 

PPPR 

54406-48-3 

Parts 1 and 2 

BPR 

135319-73-2 

Parts 1 and 2 

PPPR 

14484-64-1 

Part 2 

PPPR 

120068-37-3 

Parts 1 and 2 

PPPR 

51235-04-2 

7439-92-1 

598-63-0 

1319-46-6 

7446-14-2 

7784-40-9 

7758-97-6 

1344-37-2 

25808-74-6 

13424-46-9 

301-04-2 

7446-27-7 

15245-44-0 

and others 

8018-01-7 

7085-19-0 

93-65-2 

7439-97-6 

2032-65-7 

Part 2 

Part 1 

PPPR 

REACH 

Parts 1 and 2 

PPPR 

Parts 1 and 2 

PPPR 

Parts 1 and 2 

REACH 

Parts 1 and 2 

PPPR 

16752-77-5 

Part 2 

PPPR 

Commercial octabromodiphenyl ether, 
including hexa- and heptabromodiphenyl 
ether 

36483-60-0 

68928-80-3 

Parts 1 and 3 

RC 

29 

 
 
Delegated Act 

Chemical name 

CAS number 

Commercial pentabromodiphenyl ether, 
including tetra- and pentabromodiphenyl 
ether 

40088-47-9 

32534-81-9 

Amendment 
of Annex I 

Basis for 
inclusion 

Parts 1 and 3 

RC 

Pentachlorophenol and its salts and esters 

87-86-5 

Parts 1 and 3 

SC 

Perfluorooctanoic acid (PFOA), its salts and 
PFOA-related compounds 

and others 

335-67-1 

 and others 

Parts 1 and 2 

POP 

Thiacoprid 

111988-49-9 

Parts 1 and 2 

PPPR 

Thiophanate-methyl 

23564-05-8 

Parts 1 and 2 

PPPR 

Entries of Annex I modified during the reporting period 
Commission Delegated Regulation (EU) 2022/643 of 10 February 2022 included a complete 
replacement of Annex I to Regulation (EU) No 649/2012 in order to update many entries to 
reflect  changes  to  classifications  of  these  chemicals  in  the  European  Union’s  Combined 
Nomenclature (CN). 

Substances removed from Annex I 
The following amendments are provided in Commission Delegated Regulation (EU) 2022/643 
amending Regulation (EU) No. 649/2012. 

By Implementing Regulation (EU) 2017/150640, the Commission decided to renew the approval 
of the active substance maleic hydrazide under Regulation (EC) No. 1107/2009, with the effect 
that maleic hydrazide and its choline, potassium and sodium salts are no longer banned for use 
in  the  subcategory  ‘pesticide  in  the  group  of  plant  protection  products’.  Therefore,  those 
substances were removed from the list of chemicals in Part 1 of Annex I to Regulation (EU) 
No. 649/2012. 

The new entry on commercial octabromodiphenyl ether in Part 3 of Annex I to Regulation (EU) 
No 649/2012  also  covered the substance octabromodiphenyl  ether listed  in  Parts 1 and 2 of 
Annex I to that Regulation. Therefore, octabromodiphenyl ether was removed from the lists of 
chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No. 649/2012. 

Dicofol was a new listing in Part 1 of Annex V. Since that listing prohibited the export of dicofol 
without any exemption, the listing of dicofol in Parts 1 and 2 of Annex I to that Regulation was 
no longer required and so was removed. 

Updates of Annex V 

3.2 
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) 
2019/102141). During the reporting period, the substances outlined in Table 11 were added to 
Part 1 of Annex V. 

________________________ 
40 Commission Implementing Regulation (EU) 2017/1506 of 28 August 2017 renewing the approval of the active substance maleic hydrazide 

in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant 
protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 222, 
29.8.2017, p. 21). 

41 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.   

30 

 
 
Table 11. Chemicals added to Part 1 of Annex V during the reporting period 

Legal Act 

Commission 
Delegated 
Regulation (EU) 
2022/643 of 10 
February 2022 

Chemical name 

CAS number 

Dicofol is prohibited for export without any exemption 

115-32-2 

Perfluorooctane sulfonic acid (PFOS), its salts and perfluorooctane sulfonyl 
fluoride. 

The export ban does not apply when PFOS, its salts and perfluorooctane 
sulfonyl fluoride is used as a mist suppressant for non-decorative hard 
chromium (VI) plating in closed loop systems. 

1763-23-1, 2795-
39-3, 70225-14-8, 
56773-42-3 and 
others 

Pentachlorophenol and its salts and esters 

Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds as 
regards its presence in fire-fighting foams. The export ban only applies to 
fire-fighting foam that contains or may contain PFOA, its salts and PFOA-
related compounds. 

Decabromodiphenyl ether 

87-86-5 and others 

335-67-1 and others 

1163-19-5 and 
others 

Changes to Part 1 of Annex V 
The  entry  covering  articles  containing  concentrations  of 
tetra,  penta-,  hexa-  and 
heptabromodiphenyl ether at or above 0.1% by weight when produced partially or fully from 
recycled materials or materials from waste prepared for re-use was been amended by Regulation 
(EU)  2019/1021, 
in  articles  and  adding 
decabromodiphenyl ether. 

the  allowed  concentrations 

reducing 

A number of classifications of chemicals  in  the European Union’s Combined Nomenclature 
were changed since those chemicals were added to Annex I to Regulation (EU) No 649/2012. 
Those changes were reflected in the Annex. 

Part 2 of Annex V 
Part 2 of Annex V to the PIC Regulation lists chemicals subject to export ban other than POPs. 
Commission Delegated Regulation (EU) 2022/643 of 10 February 2022 added mercury, certain 
mixtures of metallic mercury with other substances, certain mercury compounds and certain 
mercury-added products to Part 2 of Annex V to Regulation (EU) No. 649/2012, in line with 
Regulation (EU) 2017/852. 

Table 12. Chemicals added to Part 2 of Annex V during the reporting period 

Legal Act 

Chemical name 

Commission 
Delegated 
Regulation (EU) 
2020/1068 of 15 
May 2020 

Additions to entry 3: The following mercury compounds except where they are 
exported for laboratory-scale research or laboratory analysis: 

Mercury (II) sulphate (HgSO4);  

Mercury (II) nitrate (Hg(NO3)2). 

CAS 
number 

7783-35-9,  

10045-94-0 

New entry 5: Compact fluorescent lamps (CFLs) for general lighting purposes:  

n/a 

(a) CFL.i ≤ 30 watts with a mercury content exceeding 2,5 mg per lamp burner;  

(b) CFL.ni ≤ 30 watts with a mercury content exceeding 3,5 mg per lamp burner. 

New entry 6: The following linear fluorescent lamps for general lighting purposes:  

n/a 

(a) Triband phosphor < 60 watts with a mercury content exceeding 5 mg per lamp;  

(b) Halophosphate phosphor ≤ 40 watts with a mercury content exceeding 10 mg 
per lamp. 

New entry 7: High pressure mercury vapour lamps for general lighting purposes. 

n/a 

31 

 
 
 
 
Legal Act 

Chemical name 

CAS 
number 

Commission 
Delegated 
Regulation (EU) 
2022/643 of 10 
February 2022 

New entry 8: The following mercury-added cold cathode fluorescent lamps and 
external electrode fluorescent lamps for electronic displays:  

n/a 

(a) short length (≤ 500 mm) with mercury content exceeding 3,5 mg per lamp;  

(b) medium length (> 500 mm and ≤ 1 500 mm) with mercury content exceeding 5 
mg per lamp;  

(c) long length (> 1 500 mm) with mercury content exceeding 13 mg per lamp.’.  

New entry 9: Batteries or accumulators that contain more than 0,0005% of 
mercury by weight. 

New entry 10: Switches and relays, except very high accuracy capacitance and loss 
measurement bridges and high frequency radio frequency switches and relays in 
monitoring and control instruments with a maximum mercury content of 20 mg per 
bridge, switch or relay. 

New entry 11: Cosmetics with mercury and mercury compounds, except those 
special cases included in entries 16 and 17 of Annex V to Regulation (EC) No 
1223/2009 of the European Parliament and of the Council of 30 November 2009 
on cosmetic products (OJ L 342, 22.12.2009, p. 59). 

New entry 12: Pesticides, biocides and topical antiseptics that contain mercury or a 
mercury compound that was intentionally added. 

New entry 13: 

The following non-electronic measuring devices that contain mercury or a mercury 
compound that was intentionally added: 

n/a 

n/a 

n/a 

n/a 

n/a 

(a) barometers; 

(b) hygrometers; 

(c) manometers; 

(d) thermometers and other non-electrical thermometric applications; 

(e) sphygmomanometers; 

(f) strain gauges to be used with plethysmographs; 

(g) mercury pycnometers; 

(h) mercury metering devices for determination of the softening point. 

This entry does not cover the following measuring devices: 

— non-electronic measuring devices installed in large-scale equipment or used for 
high precision measurement where no suitable mercury-free alternative is 
available; 

— measuring devices more than 50 years old on 3 October 2007; 

— measuring devices which are to be displayed in public exhibitions for cultural 
and historical purposes. 

32 

 
 
 
4 

OPERATION OF THE PIC REGULATION 

Support to exporters and importers 

4.1 
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). 

4.1.1 

Support provided by DNAs  

Awareness-raising activities   
24 Member States stated that they had carried out awareness-raising and information activities 
for exporters and importers during the reporting period (Figure 3). Regarding the 3 Member 
States that did not carry out any such activities: 1 is a smaller Member State which explained 
that they do not have an industry exporting PIC substances but for the  few imports they are 
giving support; a second larger state explained that, in general, companies are by now already 
well aware of the PIC Regulation, and questions by companies are answered on a case-by-case 
basis; the third, also a larger state, explained that information about PIC was on their website. 

Figure 3. 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?   

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 

33 

 
 
 
 
the PIC Regulation (18 Member States – 2 fewer than in the previous period42), and references 
to  the  Agency’s  webpages  on  PIC  and  ePIC  (20  Member  States  –  same  as  previously42).  9 
Member States also provided helpdesk services via an existing helpdesk (e.g. REACH, CLP, 
BPR) (same as before42) and 6 operate a national helpdesk (2 more than before42). 12 Member 
States indicated having a specific email address for information requirements (4 more than in 
the previous period42). 

As in the previous two reporting exercises, almost all (24) of the Member States that carried 
out  awareness-raising  considered  they  have  improved  exporters’  and  importers’  compliance 
with the PIC Regulation. Examples of how this improvement was manifested included:  

•  Feedback  from  industry  that  provision  of  clear  information  on  national  webpages  is 
helpful. This improves cooperation between competent authorities, control authorities 
and industry, and helps implementation of hazardous chemical-related legislation. The 
issue  of  bulletin,  guidance  and  consultations  (e.g.  by  email)  promotes  awareness, 
understanding  of  legal  duties,  and  engagement.  Regular  communication  promotes 
compliance however some duty holders remain unaware of their obligations. 

•  Dedicated  helpdesk,  and/or  e-mail  and  and/or  telephone  support/consultation  are 
considered valuable to aid understanding and increase compliance and a reduction in 
incorrect submissions.  
Increases  in  export  notifications  received  and  processed  –  sometimes  as  a  result  of 
inspection campaigns, or an improvement in quality of notifications which reduces the 
need to revert to exporters. 

• 

Regarding the other three Member States, one Member State reported new PIC activities for 
treated seeds had been required, and new categories of companies had therefore been needing 
to take action. These had been contacted through newsletters and industry associations. In the 
other two cases, one Member State provided no comments, and the other had not carried out 
any awareness-raising activities.  

Requests from exporters and importers 
As in the previous reporting period, the most frequent requests from exporters and importers to 
DNAs related to export notifications and explicit consents (Figure 4).   

________________________ 
42 For the EU 27. Data for the two UK DNAs included in the Synthesis Report for the previous period has been excluded to enable proper 

comparison in this report. 

34 

 
 
Figure 4. Question 13. On which matters do(es) the DNA(s) get the two most 
frequent requests for support coming from exporters and importers? 

One of the ‘other’ matters concerned requests for support regarding pending activation of RINs 
due to consents being missing. 

Estimated amount of time spent on support  
In the majority of Member States (18), support to exporters and importers took up to 10% or 
20%  of  the  DNA’s  workload  (Figure  5).  This  compared  with  15  and  19  Member  States  in 
periods  2017-2019  and  2014-2016,  respectively,  which  suggests  there  is  no  obvious  trend 
change in workload. Similarly, between 6 and 8 Member States selected 30% of workload or 
more  for  the  current  and  previous  two  periods  indicating  the  level  of  effort  overall  remains 
similar.  

Figure 5. Question 14: Can you estimate the amount of time spent by the DNA(s) 

on such support?  

35 

 
 
 
 
4.1.2 

Support provided by the Agency 

Awareness-raising activities 
The Agency fulfilled its obligations under Article 6 of the PIC Regulation through the following 
activities:   

Webpages on the PIC Regulation and ePIC 

The Agency improved or maintained the following dedicated landing web pages, and translated 
them in all official EU languages: 

•  Understanding PIC43  

The  PIC  Regulation  web  pages  were  revamped  by  introducing  a  new  landing  page 
(Understanding  PIC)  to  facilitate  the  navigation  between  different  sub-sections.  The 
information  was  presented  in  a  more  structured  way,  together  with  new  visual  and 
information  boxes  to  better  illustrate  the  key  points  and  processes.  In  the  context  of  the 
revamp, the content of the following sub-sections was additionally updated: 

o  Export notification procedure 
o  Explicit consent requirement 
o  Reporting on the operation of PIC Regulation 
o  Waiver information sheet 

•  ePIC – Prior Informed Consent IT system44 

Similar revamp begun for ePIC pages to align the visualisation and structure with web pages 
for other Agency IT tools. 

Direct links to the PIC Regulation legal texts (initial text, latest consolidated version, and non-
consolidated latest amendments) were made available and kept up-to-date under the Legislation 
section of the Agency’s public website.45 The Agency also published on its website the ‘PIC 
Circular’ issued twice a year by the Secretariat of the Rotterdam Convention.46 

Internal messaging in ePIC 
This means of communication was 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 

particular attention to in their export notifications; 

•  To advertise the publication of updated user manuals, new Q&As, etc.; 
•  To inform on policy changes (e.g. following an agreement at a PIC DNA meeting); 
•  To alert users in advance of maintenance breaks of ePIC and Agency closures; 
•  To inform users on new functionalities in ePIC; 
•  To inform users on performance issues, bugs etc. 

Awareness-raising campaign  
The Agency regularly informed or reminded exporters/importers of various PIC-related issues 
such as: upcoming regular legal deadlines (e.g. regarding Article 10 reporting), new or clarified 
legal obligations (e.g. entry into application of a new amendment to Annex I and/or V), peaks 

________________________ 
43 https://echa.europa.eu/regulations/prior-informed-consent/understanding-pic  

44 https://echa.europa.eu/support/dossier-submission-tools/epic  

45 https://echa.europa.eu/regulations/prior-informed-consent/legislation  

46 https://echa.europa.eu/regulations/prior-informed-consent/pic-circular  

36 

 
 
in  workload  and  related  processing  times  and  timelines  to  be  expected.  The  Agency  used 
different  communication channels  such as the  ECHA Weekly News  (by email) or the  ECHA 
Newsletter. 

Social media 
The Agency published some posts on social media (LinkedIn, Twitter, Facebook) relating to 
the implementation of the PIC Regulation, either for general awareness-raising purposes or on 
specific topics such as the publication of  the Agency’s Article 10 reports and  the Agency’s 
participation in the meetings of the Parties to the Rotterdam Convention.  

Support to individual companies 
This  support  was  mainly  provided  by  means  of  replies  to  incoming  Helpdesk  incidents  (cf. 
Question 8 for further details). 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.  The  Agency  also  contacted  individual  companies  as  regards  their  specific 
submissions  by  means  of  ‘ad  hoc’  messages  in  ePIC  to  facilitate  the  processing  of  certain 
exceptional cases (e.g. in case of IT-related issues). 

Workshops, webinars and similar training events 
In  September  2020  the  Agency  hosted  a  webinar  “Know  your  obligations  when  exporting 
hazardous chemicals outside the EU”. The webinar explained the scope and main requirements 
of the PIC Regulation and is regularly referred to as a useful piece of information in exchanges 
with stakeholders, e.g. in the context of helpdesk enquiries.47  

Information on obligations under PIC were also presented at a virtual booth “Do you know how 
the  Prior  Informed  Consent  Regulation  works  in  the  EU?”  as  part  of  the  Safer  Chemicals 
Conference which was held on-line in October 2021.  

IT user manuals, factsheets and Q&A (FAQs) 
No changes were made to the ePIC Industry user manual since the improvements to existing 
features in the industry application were self-explanatory in their nature.  

To support companies in identifying their obligations under the PIC Regulation after Brexit, 
Q&A guidance on the UK withdrawal from the EU and on the Northern Ireland Protocol (NIP) 
were developed and published48.  

No new topical factsheets were published during the reporting period however, the “In Brief - 
Proposing Waivers through ePIC” was updated to reflect the nature of the required supporting 
documents  and  related  legal  provisions.  The  Agency  worked  on  a  fact  sheet  for  exports  of 
articles  and  provided  a  first  draft  to  the  Commission  however,  the  document  has  not  been 
published yet due to a need for further clarifications on policy aspects.  

At the end of this  reporting  period, ePIC had 1 475 registered  companies of which 533 had 
actively  used  the  submission  system  in  2022.  The  number  of  active  companies  decreased 
compared to the previous reporting period due to the revocation of accounts registered in the 
UK  (specifically  GB).  The  Agency  was  of  the  opinion  that  the  support  and  communication 
activities it provided (via on-line events, information on it’s website, news items, Q&As) had 
contributed to increasing awareness of and compliance with the PIC Regulation. A substantial 
number of export notifications to UK (GB) (2021: 620, 2022: 594) were submitted after the 

________________________ 
47 The webinar, presentations and Q&A are available at https://echa.europa.eu/-/know-your-obligations-when-exporting-hazardous-

chemicals-outside-the-eu  

48 https://echa.europa.eu/advice-to-companies-q-as/pic (Brexit), and https://echa.europa.eu/advice-to-companies-q-as/northern-ireland  

37 

 
 
Brexit transition period and trade (both export and import)  was reported in accordance with 
Article 10. 

Requests to the Agency helpdesk from exporters and importers  
The  number  of  requests  received  during  the  reporting  period  by  the  Agency  helpdesk  from 
exporters and importers showed an increase 2018 – 2020, after which it started to fall returning 
to the 2016 – 2018 levels in 2022 (see Figure 6). This may have been linked in part to the Brexit 
transition as many were related to chemicals subject to the regulation and other scope related 
issues, or activation of RINs and related issues.  

Figure 6. Number of requests received by the Agency from exporters and importers 

During  the  reporting  period,  the  largest  number  of  requests  from  exporters  and  importers’ 
concerned:  

•  Follow-up questions on specific notifications, e.g.: companies do not always understand 
why no green light to export was given (“Why is my RIN not active/processed yet”) or 
why the export notification is not activated until the end of the year; change requests to 
the  information  provided  in  export  notifications  (e.g.  add/remove/change  importers, 
estimated quantities, intended export date); 

•  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; 

•  General  questions  regarding  obligations/procedures  e.g.  not  always  certain  about 

applicable procedures; 

•  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; 

•  Obligations on trade to/from the UK. 

In  addition,  the  Agency  received  a  comparatively  low  number  of  more  complex  questions, 
which required reference to expert colleagues within the Agency or the European Commission:  

•  Questions  related  to  exports  of  complex  substances  (UVCBs  as  defined  under  the 
REACH  Regulation)  containing  benzene  (e.g.  “how  to  determine  the  destination 
country  in  case  of  complex  supply  chain?”,  exemptions  covered  by  Directive 
98/70/EC); 

38 

 
 
 
•  Rules for classification and labelling of mixtures under CLP: e.g. “is the PIC substance 
present in their mixture in a high enough concentration to trigger labelling obligations 
under CLP?” or “is supplementary labelling a trigger for a notification?” 

•  Questions  related  to  scope  of  the  PIC  Regulation  e.g.  exports  of  cosmetic/medicinal 

products, treated seeds or articles. 

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

Estimated amount of time spent on such support 
During this reporting period, an average of six members of the PIC Operations Team in the 
Submission and Processing Unit (A3) were directly involved in providing replies to the requests 
received from companies via the ECHA Helpdesk.49 They spent on average, approximately 10% 
of their time on this specific activity (i.e. a total of 0.6 FTE). This represents the same level of 
loading and resource expended as the previous reporting period. 

Export notifications sent to Parties and other countries (Article 8) 

4.2 
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 non-EU 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. 

4.2.1  Export notifications processed during the reporting period50 
During  the  reporting  period,  DNAs  accepted  and  forwarded  to  the  Agency  32 270  export 
notifications, compared with 28 489 in the period 2017-2019 and 15 771 in the period 2016-
2014 (Figure 7). The number of notifications accepted and forwarded by DNAs grew rapidly 
from 2014-2016 since when it steadily increased until 2021. The 8% drop in 2022 may have 
been partly caused by the exit of the UK (GB). In the previous period the UK processed 2 207 
notifications. 

________________________ 
49 https://echa.europa.eu/contact  

50 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.   

39 

 
 
Figure 7. Number of export notifications accepted and forwarded to the Agency by 

DNAs per year 

The  number  of  export  notifications  processed  varied  significantly  between  Member  States 
(Figure 8). Three Member States did not process any export notifications during the reporting 
period (Cyprus, Luxembourg and Malta - all of whom carried out no processing in the previous 
period),  one  Member  State  (Estonia)  processed  fewer  than  10  notifications,  and  a  further  5 
Member States fewer than 100 notifications. The highest numbers of export notifications during 
the  reporting  period  were,  as  in  the  previous  period,  in  Germany  (9 413  versus  8 645)  and 
France (7 184 versus 6 855). This was followed by Belgium (3 679 versus 2 019), Italy (2 633 
versus 2 453), Spain (3 109 versus 2 383) and the Netherlands (1 930 versus 1 029). 

Figure 8. Number of export notifications accepted and forwarded to the Agency by 

DNAs during the reporting period51 

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

40 

 
 
 
 
21 Member States processed more export notifications during this reporting period compared 
to the previous one (see Table 13).  

Table 13. Number of export notifications accepted and forwarded to the Agency by 

DNAs in the reporting periods 2014-2016, 2017-2019, and 2020-2022  

Member State 

2014-2016 

2017-2019 

2020-2022 

Export notifications accepted and forwarded to the Agency 

Belgium 

Bulgaria 

Czechia 

Denmark 

Germany 

Estonia 

Ireland 

Greece 

Spain 

France 

Croatia 

Italy 

Cyprus 

Latvia 

Lithuania 

Luxembourg 

Hungary 

Malta 

Netherlands 

Austria 

Poland 

Portugal 

Romania 

Slovenia 

Slovakia 

Finland 

Sweden 

766 

107 

55 

115 

5 196 

1 

30 

1 

1 265 

3 358 

47 

1 321 

4 

0 

38 

0 

29 

8 

588 

361 

232 

58 

7 

0 

46 

93 

216 

2 019 

227 

102 

193 

8 645 

1 

63 

0 

2 383 

6 855 

106 

2 453 

0 

28 

17 

0 

86 

0 

1 029 

783 

661 

141 

7 

74 

14 

102 

293 

3 679 

278 

123 

424 

9 413 

5 

145 

297 

3 109 

7 184 

125 

2 663 

0 

18 

42 

0 

460 

0 

1 930 

524 

791 

236 

22 

321 

20 

78 

383 

In  Member  States  who  processed  more  than  50  notifications,  2  saw  a  fall  in  processed 
notifications (Austria 33% and Finland 24%) but 16 saw a rise. Of these Member States, 3 saw 
a rise of up to 10%, 6 between 10% and 50%, and 3 between 50 and 100%. 4 Member States 
saw the number of notifications processed more than doubled (Denmark 120%, Ireland 130%, 
Slovenia  334%,  and  Hungary  435%).  In  absolute  terms,  Belgium  (1 660),  followed  by  the 
Netherlands  (901),  Germany  (768)  and  Spain  (726)  experienced  the  largest  increase  in 
notifications processed. This movement is illustrated in Figure 9 below. 

41 

 
 
 
Figure 9. Number of export notifications accepted and forwarded to the Agency by 
DNAs compared with the previous reporting period for those DNAs 
processing the most notifications 

The Agency also reported an increase of export notifications accepted and processed during the 
reporting period (compared with 8 455 in 2017, 9 704 in 2018, and 10 009 in 201952 (Table 
14)). 1 475 companies were registered  (of which 533 active users) in ePIC at the end of the 
current reporting period (see section 4.1.2) compared with 2 343 (of which 578 active) at the 
end  of  the  previous  reporting  period  (2019).  Thus,  there  is  no  correlation  of  the  increase  in 
notifications with the number of users registered or active. This would suggest that, in general, 
submissions per company increased. 

Table 14. 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 

2020 

11 250 

9 472 

6 367 

3 105 

2021 

11 292 

9 724 

6 698 

3 026 

2022 

10 396 

9 227 

6 568 

2 659 

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 the Agency’s workload. 

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

42 

 
 
 
 
Special RIN requests processed during the reporting period   

4.2.2 
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  12 512  Special  RIN  requests,  a  rise  of  11% 
compared to 11 327 requests in the period 2017-2019. The number of requests in the period 
2014-2016 were 7 072. Thus, while the number of Special RIN requests accepted and forwarded 
by DNAs continuously increased since 2014, the rate of increase slackened. This is illustrated 
in Figure 10. 

Figure 10. Number of special RIN requests accepted by DNAs per year 

The  number  of  special  RIN  requests  processed  varies  by  four  orders  of  magnitude  between 
Member States (Figure 11). In the previous reporting period, 11 Member States did not have to 
deal  with  any  Special  RIN  requests  (Bulgaria,  Cyprus,  Estonia,  Greece,  Latvia,  Lithuania, 
Luxembourg, Malta, Portugal, Romania, and Slovakia). This remained the case for all of these 
States except Greece, Lithuania, Romina and Slovakia. Germany, Belgium and France were the 
Member States that  accepted the highest  number of  special RIN requests as  in the previous 
period. 

43 

 
 
 
Figure 11. Number of special RIN requests accepted by DNAs during the reporting 

period 

In the 10 Member States who processed more than 50 requests, 2 were almost at the same level 
as the previous period (Italy and Slovenia), 2 saw a fall (Poland 25% and Spain 14%), and 6 
saw a rise (France 68%, Austria 62%, Hungary 48%, Sweden 30%, Belgium 25%, and Germany 
11%).  In  absolute  terms,  France  (800),  Germany  (518),  Belgium  (471)  and  Austria  (372) 
experienced the largest increase of requests (Table 15). 

Table 15. Number of Special RIN requests accepted by DNAs in the reporting periods 

2014-2016, 2017-2019 and 2020-2022 

Member State 

2014-2016 

2017-2019 

2020-2022 

Belgium 

Bulgaria 

Czechia 

Denmark 

Germany 

Estonia 

Ireland 

Greece 

Spain 

France 

Croatia 

Italy 

Cyprus 

Latvia 

Lithuania 

1 156 

0 

44 

13 

3 121 

0 

29 

0 

555 

577 

33 

46 

0 

0 

0 

1 897 

0 

41 

9 

4 896 

0 

4 

0 

623 

1 171 

101 

101 

0 

0 

0 

2 368 

0 

46 

0 

5 414 

0 

1 

0 

537 

1 971 

29 

99 

0 

0 

19 

44 

 
 
 
 
Member State 

2014-2016 

2017-2019 

2020-2022 

Luxembourg 

Hungary 

Malta 

Netherlands 

Austria 

Poland 

Portugal 

Romania 

Slovenia 

Slovakia 

Finland 

Sweden 

0 

0 

0 

29 

165 

226 

5 

0 

21053 

164 

5 

82 

0 

279 

0 

39 

600 

418 

0 

0 

122 

0 

1 

140 

0 

413 

0 

16 

972 

315 

0 

2 

123 

3 

2 

182 

4.2.3  Requests for resubmission and rejection of export notifications 
Member States requested the resubmission of 3 010 export notifications during the reporting 
period, compared to 5 889 requests for resubmission during the period 2017-2019 and 2 904 
during the period 2014-2016 (Figure 12). In the previous report (2017-2019) it was suggested 
that the increase in resubmission requests compared with the period before (2014-2016) was 
probably  the  consequence  of  the  increase  in  the  number  of  export  notifications  accepted  by 
DNAs (see section 4.2.1). However, in the present period (2020-2022) the number of export 
notifications accepted by DNAs has risen while the number of resubmission requests has fallen 
markedly. One possible reason for this may be that companies, in particular those who make 
multiple separate notifications, have a better understanding of the requirements and so make 
fewer mistakes.  

Figure 12. Number of resubmissions of export notifications requested by DNAs per 

year 

As  in  the  previous  reporting  period,  variations  between  Member  States  in  the  number  of 
resubmissions requested corresponded to variations in the number of notifications handled, i.e. 
Member States that handled a high number of notifications (e.g. FR, DE, BE, ES and IT) were 
also generally those that requested resubmissions more frequently (Figure 13). 

________________________ 
53 Corrected figure for this year provided by Slovenia. Previous report stated “0”. 

45 

 
 
 
 
Figure 13. Number of resubmissions of export notifications requested by DNAs in 

the reporting period 

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  reasons  for  requesting 
resubmission as illustrated in Figure 14.  

Note that not all Member States provided responses to every question where not judged to be 
relevant. 

The other reasons comprised: 

•  Cases where the importing country explicitly stated that it does not wish to receive a 

particular chemical – cited as most frequent by 1 Member State; 

•  Discrepancy between inputs in Sections 3.3 (foreseen use) and 6.2 (allowed/prohibited 
uses). This was thought likely to be as a result of the exporter not consulting the user 
manual prior to filling out the form. Most of the times Section 6.2 contained product 
descriptions and not information on the prohibited/allowed uses in the EU of the PIC 
substance(s)  triggering  the  notification  obligation  –  cited  as  most  frequent  by  one 
Member State; 

•  Delay in the payment of administrative fee – cited as next least frequent by one Member 

State; 

Information requirements not met. Several export notifications for mixtures that contain only 
one and the same PIC substance in similar mixtures with different flavours when classification 
and labelling of the mixtures and the uses remain the same – cited as next least frequent by one 
Member State. 

46 

 
 
 
 
 
Figure 14: Question 20. Most frequent reasons for requesting resubmission of 

export notifications 

Information requirements not met in section 1 of the export notification form, on 
the identity of the chemical subject to the export notification54 

Information requirements not met in section 3 of export notification form: 
e.g. Information concerning the export55  

Information requirements not met in section 4 of the export notification form56 

Information requirements not met in section 6, for example: Incomplete 
summary of, and reasons for, the FRA date of entry into force 

Incorrect filling of section 6.2 ‘The final regulatory action has been 
taken for the category’ 
Incorrect filling of section 6.2, other issues57  

Issues with the data provided in Section 6.1 ‘Summary of and reasons for the 
final regulatory action and date of entry into force’ (incorrect text/language) 

The incorrect SDS has been attached 

The SDS is unavailable because it has been attached 
in the incorrect place in the ePIC form 

SDS not provided in the right language 

Composition of mixtures on the SDS does not match the export notification 

The type of product given in the SDS did not match the export notification 

Errors in the SDS, for example with respect to codes 

Other reasons (not listed above) 

The  Agency  requested  the  resubmission  of  1 760  export  notifications  during  the  reporting 
period, compared to 2 758 in the period 2017-2019 and 609 in the period 2014-2016 (Figure 
15). The trend is similar to that of resubmissions requested by DNAs (see Figure 12) – with a 
peak in 2018 and decreases in the last year of the reporting period, 2016 and 2019.  

In 2020 and 2021, the main reason for resubmission requests was related to unclear or irrelevant 
information under Section 6.2 on prohibited and allowed uses. This was the reason for many 
cases in 2022. Other reasons for resubmission requests in 2020 were incomplete or incorrect 
importers’ details, discrepancies between the information in the SDS and in the notification or 
incorrectly categorized intended uses. 

In  2021,  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 SDS, irrelevant information included in the section for the intended use 
in the importing countries, incomplete contact details for the importers, or unnecessary multiple 
submissions for the same mixture which only differed in the colour of the product. Similarly in 

________________________ 
54 For example, CAS number incorrect, concentrations incorrect, or incorrect name of product. 

55 For example, invalid phone nr., missing importer address; exporter incorrectly ticked emergency situation box to avoid 35-day waiting 

period. 

56 For example, information on hazards and/or risks of the chemical and precautionary measures, e.g. wrong classification. 

57 For example, Errors in allowed uses; Inadequate information provided on prohibited uses; 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’. 

47 

 
 
 
 
2022, many resubmission requests were due to inconsistencies between the concentration of the 
PIC substance in the mixture as stated in the export notification (Section 2.5) and in the attached 
SDS or because additional PIC chemicals were identified in the SDS that were not included in 
the notification. 

Figure 15. Number of resubmissions requested by the Agency per year58 

Member  States  rejected  738  export  notifications  during  the  reporting  period,  which  is  an 
increase from 544 in the period 2017-2019. Even so the overall level of rejections remains well 
below the peak experienced in 2016 (Figure 16). 

Figure 16. Number of export notifications rejected by DNAs per year 

As  above,  variations  between  Member  States  in  the  number  of  notifications  rejected 
corresponded  to  variations  in  the  number  of  notifications  handled,  i.e.  Member  States  that 
handled  a  high  number  of  notifications  awee  also  generally  those  that  rejected  notifications 
more frequently (Figure 17). 

As  in  the  previous  two  reporting  periods,  the  main  reason  reported  by  DNAs  to  reject  a 
notification is the duplication of notifications (Figure 18). Other frequent reasons mentioned 
were that the notification was rejected at the request of the export company, or the information 
requirements were not met correctly. 

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

48 

 
 
 
 
 
Figure 17. Number of export notifications rejected by DNAs in the reporting period 

Figure 18: Question 20. Most frequent reasons for rejecting export notification 

Duplication of notifications 

Negative consent from importing country 

Rejection requested by the export company e.g. exports cancelled; a 
validated notification could cover similar mixtures when not needed 

Wrong identification, for example substance identified as a mixture 
(selection of the wrong template) 

The resubmission occurred too late 

Information requirements not met or incorrect information provided 

Conditions for granting a special RIN were met 

Missing SDS / SDS not in appropriate language 

The emergency situation was not justified 

The importing country waived the export notifications for the export 

PIC chemical missing in mixture 

The mixture was not hazardous, based on the SDS 

Substance was notified in a mixture at a concentration level which did 
not trigger labelling of the mixture in CLP 

Other reasons (not listed above) 

49 

 
 
 
 
 
 
 
 
Note that not all Member States provided responses to every question where not judged to be 
relevant. 

The only other, and most frequent reason for rejection regarded enforcement of Article 83 of 
the French law - EGALIM (Export ban of pesticides in mixtures for agriculture uses). A second 
reason for rejection was with regard to notification of treated seeds as articles. 

The Agency rejected more notifications (394) during the reporting period than in the period 
2017-2019 (212) (Figure 19) as did DNAs (Figure 16). The overall trend appears to be a gradual 
rise in rejections by the Agency.  

Figure 19. Number of export notifications rejected by the Agency per year 

Over the entire period, most rejections were due to unnecessary duplicate notifications. Other 
reasons  which  arose  throughout  the  period  were  selection  of  the  wrong  template  for  the 
notification  (e.g.  mixture  instead  of  pure  substance  or  vice  versa),  and  rejection  owing  to  a 
mismatch between the stated importing country and the importer’s address. In 2020 and 2022, 
rejections at the request of the exporting companies were mentioned. In 2020 and 2021, some 
notifications were rejected because they should have been submitted as special RIN requests.  

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 mainly experienced difficulties to provide information in the 
following areas:  

•  The availability of CN codes or CUS codes, and information on the export itself (such 
as the contact details of the importer) where there has been little or no improvement 
since the previous period, and 

•  The intended use of the chemical in the importing country where difficulties have fallen 

significantly.  

There had been a particular reduction in reported difficulties concerning:  

•  Summary of and reasons for the final regulatory action and date of entry into force, and 
• 

Information on the final regulatory action taken by the European Union. 

Compared  to  the  previous  reporting,  the  number  of  Member  States  replying  ‘none’  only 
increased  by  one  (Figure  20)  to  11.  Of  these,  7  Member  States  processed  fewer  than  100 
notifications per annum, and the other 4 fewer than 300 notifications per annum. 

Under ‘other’, the issue was improper completion of sections 6.2 and 6.3 of the form. 

50 

 
 
 
 
In addition to these issues, one or two DNAs highlighted difficulties with:  

•  Providing a current SDS and in the correct language; 
•  Clarity regarding section 6.2. Exporters were not clear that this section refers to Section 

6.1; 

•  Export  of  plant  protection  products  to  Ukraine.  In  many  cases  the  exporters  do  not 

provide the Ukrainian authorisation number. 

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

•  “Prohibited  and  allowed  uses”  (Section  6.2):  companies  seemed  unaware  of  the 
prohibited  and/or  allowed  uses  of  the  exported  PIC  chemical  since  the  information 
provided was often incorrect or misleading, and sometimes reflected more the intended 
uses in the importing country rather than the regulatory status in the EU; 

•  Confusion on what was being exported and discrepancies of information between the 
notification  and  the  associated  SDS:  The  concentration  of  the  PIC  substance  in  the 
exported mixture (Section 2.5) did not correspond to the information provided in the 
SDS  (Section  3);  The  selected  export  notification  template  (i.e.  chemical,  mixture, 
article) did not correspond the information provided in the SDS; 

Figure 20. Question 19. What are the information requirements requested in the 
export notification form where exporters have difficulties in providing the 
information? 

51 

 
 
 
• 

Importer(s)  details  (Section  3.4):  exporters  often  provided  incomplete  or  incorrect 
contact  details  for  the  trade  partners  in  the  country  of  destination.  They  also  often 
referred  to  importers  who  could  not  be  identified/reached  by  the  authorities  of  the 
importing country; 

•  The  use  category  and  foreseen  use  in  the  importing  country:  for  exports  of  biocidal 
active substance/products there could be misunderstandings and complications in the 
processing, because the EU considers a biocidal use as a sub-category of the pesticides 
category,  but  many  non-EU  countries  consider  biocidal  substances/products  as 
industrial chemicals. Also, the foreseen uses in the importing country under Section 3.3 
were often inadequately described, which might lead to misunderstandings and delays 
of the processing in the destination country. 

As in the previous period, both the Agency and the DNAs highlighted Section 6.2 as a part of 
the  notification  where  exporters  experienced  most  difficulties  in  providing  the  requested 
information. It was also one of the main reasons for resubmission requests.  

Complying with timeframes 
According  to  the  Agency,  DNAs  experienced  difficulties  in  coping  with  the  timeframe  to 
forward the export notifications to the Agency. As shown in Table 16, the number of export 
notifications  forwarded  late  remained  relatively  low  compared  to  the  total  number  of 
notifications processed (4.9% of the total). Whilst the number of notifications reduced steadily 
over the current reporting period (to 3.6%), there was no immediately obvious trend across the 
period 2014 to 2022. 

Table 16. Number of export notifications received late by the Agency per year 

Year 

Number of late notifications    % of total yearly number of notifications  

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

2022 

Total 2014-2016   

Total 2017-2019   

Total 2020-2022   

 6 

 348 

 371 

 312 

 880 

 594 

 640 

 619 

 378 

 725 

1 786 

1 637 

1.2% 

6.4% 

4.7% 

3.7% 

9.1% 

5.9% 

5.7% 

5.5% 

3.6% 

4.9% 

6.3% 

4.9% 

right  after 

As mentioned in the previous period report, the Agency noticed that the difficulties of certain 
Member State DNAs to cope with the legal timeframe for the checking of export notifications 
usually  appeared  during  and 
in 
November/December/January months. This was especially the case when these coincided with 
holiday periods when very limited or no resources for processing were available. The situations 
in  which  the  Agency  received  export  notifications  late,  often  related  to  re-submissions  (the 
notification was sent back to the exporter for correction) without a request to change the export 
date,  in  which  case  the  deadlines  remained  the  same  as  for  the  initial  submission.  It  was 
recommended  that  DNAs  provide  the  companies  with  a  clear  deadline  by  when  the  re-

the  peak  submissions  periods; 

i.e. 

52 

 
 
submission should be done at the latest, and possibly require a change of foreseen export date 
so as to allow sufficient  processing time for both the Member State DNAs and  the Agency. 
Alternatively, it could be considered that re-submissions are dealt with in the same timeframe 
as initial submissions (clock set back to 35 days) and ePIC adapted accordingly. 

Three Member States (the same number as in the previous reporting period) reported difficulties 
in complying with a timeframe to forward the notifications to the Agency. In the previous period 
the  three  Member  States  were  among  those  that  process  the  largest  number  of  export 
notifications (France, Germany and Italy). In the present period, Italy cited the same difficulty 
while  Austria  mentioned  difficulties  when  companies  notify  very  late  and  both  DNA 
representatives  were  unavailable,  and  Portugal  mentioned  difficulty  in  ensuring  payment  of 
their administrative fee within the established deadline. 

The Agency reported that the number of export notifications which were forwarded later than 
15  days  before  the  expected  date  of  export  specified  in  the  notification  had  significantly 
decreased over the reporting period. The Agency had reminded Member State DNAs on several 
occasions (during DNA meetings, emails) about the importance to adhere to the legal deadlines 
so that enough time  was provided to  the  authorities in  the importing country to  react  to  the 
notifications. Typically issues related to re-submissions and either a notification received from 
the DNA was already overdue (less than 15 days before the expected date of export) or very 
close  to  the  due  date  or  late.  When  the  Agency  noticed  that  the  exporter  had  submitted  the 
export  notification  on  time  and  that  the  delay  was  due  to  late  processing  by  the  DNA,  and 
provided that all the required information had been submitted, the Agency processed the late 
export notification immediately, in order not to further penalise the exporter and to allow the 
export process to continue. 

Table 17. Number of export notifications processed late by the Agency per year 

Year 

Number of late notifications   

% of total yearly number of notifications  

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

2022 

Total 2014-2016   

Total 2017-2019   

Total 2020-2022   

 3 

 18 

 9 

 14 

 42 

 4 

 21 

 15 

 7 

 30 

 60 

 43 

0.7% 

1.4% 

1.1% 

0.2% 

0.4% 

0.04% 

0.2% 

0.1% 

0.1% 

1.2% 

0.2% 

0.1% 

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.  

The Agency reported that more export notifications were submitted in accordance with Article 
8(5) compared to previous reporting period (51 versus 15). Of these 22 were validated - these 

53 

 
 
cases mainly concerned disinfectants in relation to the Covid-19 pandemic. The other 29 were 
found not to meet the criteria described in Article 8(5) and were rejected by the Agency or by 
the  Member  State  DNAs.  The  companies  were  asked  to  submit  a  new  “standard”  export 
notification instead. These rejected cases referred to situations where companies tried using the 
emergency  notification  to  overcome  the  waiting  period  specified  in  Article  8(2),  or  the 
justification provided by the company was not found adequate. 

During  the  reporting  period,  4  Member  States  reported  having  to  deal  with  an  emergency 
situation:  

•  Germany’s case concerned a component in a Covid-19 test. They noted that the ECHA 
Guideline states that a special RIN had to be generated, but pointed out that in reality 
an export notification plus additional proving papers must be generated in ePIC; 

•  Poland’s  case  concerned  the  export  of  chloroform  (CAS  67-66-3)  used  for  the 
production  of  chemicals  used  various  critical  laboratory  and  industrial  applications 
including those in hospitals, pharmaceuticals and environmental protection agencies; 
•  Slovenia’s  case  concerned  an  urgent  need  for  personal  protective  products  in  the 

destination country; 

•  Spain’s  case  concerned  disinfectant  products  containing  didecyldimethylammonium 

chloride, (CAS 7173-51-5) required to combat the Covid-19 pandemic. 

Provision of available additional information on exported chemicals  

4.2.6 
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  high  number  of  requests  from 
authorities in importing countries to provide additional information or 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.   

Six  DNAs  (compared  to  five  in  the  period  2017-2019  and  eight  in  the  period  2014-2016) 
received similar requests. Information requested by the importing countries related primarily to 
importer contact details but also substance concentrations. One DNA pointed out that in most 
cases, they have to correspond with the importing country until clarification is achieved and 
this  requires  time  and  resources.  Responses  for  explicit  consent  and  case  studies  were 
sometimes delayed by the DNA of importing countries or not provided making it extremely 
difficult for the exporters’ DNA to work.   

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.  

Seven  Member  States  requested  an  administrative  fee  for  export  notifications  (Belgium, 
Bulgaria, Finland, Germany, Hungary (depending on the DNA), Portugal, and Slovenia) as in 
the previous reporting period. However, Greece no longer requested a fee. Fees vary greatly 
between Member States from EUR 35 to EUR 276, as compared to a range from EUR 25 to 
EUR 265 in the previous period.  

54 

 
 
As in the previous reporting period, four Member States required a fee for requests for explicit 
consent.  Three  of  these  (Finland,  Germany  and  Portugal)  were  the  same  as  in  the  previous 
period, however Bulgaria no longer required a fee. The new Member State requiring a fee was 
Greece  (depending  on  the  DNA  concerned).  Fees  ranged  from  EUR  108  to  EUR  276,  as 
compared to EUR 25 to EUR 265 in the previous period.  

As in the previous period, no complaints were reported regarding fees levied and these were 
generally  not  considered  to  have  an  impact  on  the  number  of  notifications,  although  one 
Member  State  suggested  the  fee  may  deter  precautionary  notifications  submitted  (i.e.  those 
which are not used). 

Export notifications from Parties and other countries (Article 9) 

4.3 
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 (Article 9).  

The Agency received 1 863 export notifications from non-EU countries in the reporting period, 
which is more than in the previous reporting period (1 371 notifications) (see Table 18). The 
number of notifications increased considerably across the reporting period from a low in 2020 
to over twice that in 2022. The Covid-19 pandemic may have had an impact on the number of 
notifications in 2020, but the introduction during the period of the new entry “Benzene as a 
constituent of other substances in concentrations equal to, or greater than 0.1% by weight”, is 
likely to have had a significant impact.59 

Table 18. Export notifications received from non-EU countries and acknowledgements 

sent during the reporting period 

2020 

Export notifications received    

381 

Acknowledgements sent   

82 

2021 

671 

506 

2022 

811 

470 

Total 

1 863 

1 058 

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. 

Information on export and import of chemicals (Article 10)  

4.4 
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  non-EU 
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. 

________________________ 
59Trade in products containing benzene increased EU imports of hazardous chemicals, ECHA/NR/23/34, 20 December 2024  

https://echa.europa.eu/-/trade-in-products-containing-benzene-increased-eu-imports-of-hazardous-chemicals: “Substances containing 
benzene is the first “substance in substance” entry under the PIC Regulation, with 96% (18 845 530,34 tonnes) of imports reported in 2022 
concerning these substances.”  

55 

 
 
 
Delays in collecting information   
Seven  Member  States  (one  more  than  in  the  previous  reporting  period61)  stated  that  they 
experienced  delays  from  exporters  in  the  submission  of  information  on  the  quantity  of  the 
chemical exported, requiring to send reminders.  

Nine Member States (compared to five in the previous reporting period and eight in the period 
before  that)  indicated  that  they  had  experienced  delays  from  importers  in  submitting  their 
information.  For  both  exports  and  imports  issues  that  were  reported  by  Member  States, 
responses included: 

•  The sometimes needed to send out multiple reminders to report even after the reporting 

deadline (e.g. in April). 

•  Late submissions of reports from companies. An example was provided of having to 
take enforcement action to persuade one company to submit which they eventually did 
but only after the deadline. 

•  Orphan reports had to be addressed every year (statistics cannot be retrieved from ePIC). 

Issues for reporting of exports included: 

•  Delays due to misunderstanding of obligation or sporadic use of ePIC. This included 
lack of awareness of the need to report actual quantities exported in the last year and 
that this also included the case where there were zero exports. 

•  One Member State noted that when an email address was updated by a company in the 
contact  sheet  it  did  not  synchronise  with  the  email  address  that  appeared  on  a 
notification. Therefore, time was lost trying to use outdated emails addresses. 

For reporting of imports, particular issues included: 

•  For  one  Member  State,  all  companies  importing  from  UK  were  not  aware  of  the 

• 

• 

reporting requirement when it started (2021 imports).  
Importers  were  not  always  aware  of  their  requirements  and  the  need  to  provide  the 
information via ePIC. 
Information on chemicals subject to the PIC regulation was received late at the national 
level.  The  ePIC  system  was  closed  at  that  time  and  it  was  technically  impossible  to 
submit this information. 

•  Delays owing to incomplete information from some of the companies mentioned in an 
import notification. There were delays as these companied were contacted to confirm 
the import and obtain the quantities imported in 2021. 

Reporting through ePIC   
No Member States reported difficulties in making their Article 10 submissions through ePIC. 
Only  two  Member  States  reported  delays  in  doing  so  both  citing  missing  information  from 
exporters or importers – sometimes owing to holiday periods.   

Based on the issues identified during the previous reporting period, the Agency improved the 
reporting functionality in ePIC by introducing warnings to potentially erroneous quantities to 
improve the quality of the data submitted by industry, and to assist the checking of the data by 
DNAs. It also prepared a checklist for DNAs to help them in verifying industry reports, and in 
submitting their national reports. The number of mistakes in quantities have decreased however, 
issues  were  still 
the  EU-level  report  and 
corrections/clarifications were needed. The mistakes identified were typically related to very 
high  quantities. A careful  verification of industry data by DNAs before the aggregation and 
submission to the Agency was recommended. 

the  compilation  of 

identified  during 

56 

 
 
Aggregating information at EU level   
Unlike in the previous two reporting periods, the Agency did encounter delays from DNAs in 
receiving the aggregated national reports on the quantity of exported and imported chemicals 
by the agreed deadline (i.e. by the end of September) from some Member States. The Agency 
followed this up in each case by sending reminders and offering additional support (by phone, 
targeted emails with instructions on steps to take). Delays in receiving the national reports, and 
mistakes  contained  in  them,  continually  led  to  inefficiencies,  slowing  down  the  Agency’s 
preparations, compilation and publication of the EU-level reports, as well as requiring more 
support and hence resources from the Agency PIC Team.  

The Agency recommended that DNAs monitor the progress of industry reports and follow-up 
the timely reporting and/or revisions by companies, as needed. It was apparent from the DNA’s 
reports that in many cases diligent and timely efforts are made to effect this, but the required 
cooperation and response was not always forthcoming.  

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 12 Member States. Five DNAs specifically mentioned the data is 
used  by  customs  authorities.  Eight  DNAs  indicated  that  the  data  are  used  for  enforcement 
activities,  with  two  specifying  that  it  was  used  for  checking  compliance  with  REACH 
restrictions.  This  information  was  also  shared  with  enforcement  colleagues  working  on 
pesticides (PPPR and BPR) in two Member States. 

Notification of banned or severely restricted chemicals under the Convention  

4.5 
Under  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 the Agency, drafts the notifications, which 
are submitted to DNAs and observers for comments before being submitted to the Secretariat. 
Thirty-one notifications were submitted to the Secretariat during the reporting period: 60  

•  5-tert-butyl-2,4,6-trinitro-m-xylene 

(Musk xylene) (2022) 
•  Arsenic pentoxide (2022) 
•  Benzyl butyl phthalate (2022) 
•  Chlorothalonil (2021) 
•  Chlorpropham (2021) 
•  Chlorpyrifos (2022) 
•  Cybutryne (2020) 
•  Diisobutyl phthalate (2020) 
•  Dimethoate (2021) 
•  Diquat (2021) 
•  Ethoprophos (2021) 
•  Fenamidone (2022) 
•  Flupyrsulfuron (2020) 
•  Flurtamone (2022) 
• 
Isoproturon (2020) 

•  Linuron (2020) 
•  Mancozeb (2022) 
•  Mercury (2022) 
•  Methiocarb (2022) 
•  Orthosulfamuron (2020) 
•  Oxasulfuron (2022) 
•  Propineb (2022) 
•  Pymetrozine (2022) 
•  Quinoxyfen (2022) 
•  Tepraloxydim (2022) 
•  Thiamethoxam (2022) 
•  Thiram (2022) 
•  Triasulfuron (2020) 
•  Triclosan (2020) 
•  Tricyclazole (2020) 
•  Tris(2-chloroethyl) phosphate (2020) 

________________________ 
60 https://www.pic.int/Countries/CountryProfiles/tabid/1087/language/en-US/Default.aspx, select region European Union, select tab 

‘Submissions’ then ‘Final Regulatory Actions’ to see a list of “Notifications of Final Regulatory Action - Non-Annex III Chemicals” 

57 

 
 
Obligations in relation to importing chemicals (Article 13)  

4.6 
Under 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 EU 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 that provided 
new  import  decisions  for  phorate  and  hexabromocyclododecane,  and  amended  existing 
decisions concerning two commercial brominated diphenyl ethers and PFOS (Table 19). 

Table 19. EU import responses adopted during the reporting period 

Import 
decision 

Grounds 
for decision 

No consent to 
import 

Banned for 
use by PPPR 

No consent to 
import 

Banned for 
use by POPs 
Regulation   

Implementing 
Act* 

Chemical names 

CAS number 

(EU) 2020/2182 of 
18 December 2020 

Phorate 

Hexabromocyclo-dodecane 

Commercial 
pentabromodiphenyl ether 
including  

- tetrabromodiphenyl ether  

- Pentabromo-diphenyl ether 

298-02-2 

134237-50-6, 
134237-51-7, 
134237-52-8, 
25637-99-4,  

3194-55-6 

40088-47-9,  

32534-81-9 

Nature / 
status of 
decision 

New 
decision / 
Final 

New 
decision / 
Final 

Modified 
decision / 
Final 

Commercial 
octabromodiphenyl ether 
including: 
Hexabromodiphenyl ether 
Heptabromodiphenyl ether 

36483-60-0, 

68928-80-3 

Modified 
decision / 
Final 

Consent to 
import only 
subject to 
specified 
conditions   

Consent to 
import only 
subject to 
specified 
conditions   

Modified 
decision / 
Final 

Consent to 
import only 
subject to 
specified 
conditions   

Perfluorooctane sulfonic 
acid, perfluorooctane 
sulfonates, perfluorooctane 
sulfonamides and 
perfluorooctane sulfonyls 
(PFOS) 

1763-23-1,  

2795-39-3, 

29457-72-5, 

29081-56-9, 

70225-14-8, 

56773-42-3, 

251099-16-8, 

4151-50-2, 

31506-32-8,  

1691-99-2, 

24448-09-7, 

307-35-7 

* Commission Implementing Decision 

Exemption for 
continued use 
for spare parts 
/upgrade in 
certain EEE 
provided by 
RoHS 
Directive 

Exemption for 
continued use 
for spare parts 
/upgrade in 
certain EEE 
provided by 
RoHS 
Directive 

Banned for 
use by POPs 
Regulation - 
specific 
derogation 

58 

 
 
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 generally fulfilled this 
requirement  by  email,  newsletters,  or  via  their  website.  However,  seven  Member  States 
indicated that they did make EU import decisions available. 

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  continuing  main 
difficulty. More Member States dealt with Article 14(6) and (7) provisions than in the previous 
period with a significantly increased volume of work which had proved challenging. Even so, 
the information provided by DNAs suggested that implementation problems were manageable.  

The  Agency  reported  no  difficulties  with  the  implementation  of  Article  14(8)  and  that  the 
majority of the cases were processed following standard workflows within ePIC. No Member 
States had been requested by importing Parties to advise and/or assist them in obtaining further 
information  needed  to  prepare  a  response  to  the  Secretariat  of  the  Rotterdam  Convention 
concerning the import of a given chemical (Article 14(5)). 

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 fulfilled this requirement, mainly 
through emails and the provision of information on their website (Article 14(3)). One Member 
State also used the telephone, and another ran an annual workshop on chemicals management. 

4.7.2  Explicit consent (Article 14(6))  
Nineteen  Member  States  (one  more  than  in  the  previous  reporting  period61)  sought  explicit 
consent from the DNA of the importing country, under Article 14(6)(a) of the PIC Regulation. 
A total of 7 233 requests for explicit consent were processed by DNAs in the present period 
compared with 5 058 in the period 2017-2019, and 3 362 in the period 2014-2016. As in the 
previous reporting period, the Member States that  processed the highest number of requests 
were Germany, France, Belgium, Spain, and the Netherlands (Figure 21). 

________________________ 
61 Data for the UK has been excluded to enable proper comparison. 

59 

 
 
 
Figure 21. Number of requests for explicit consent processed by DNAs during the 

reporting period 

In 13 Member States (out of 19), the number of requests processed by the DNA was higher than 
in  the  previous  reporting  period.  In  8  Member  States,  the  increase  was  quite  significant  as 
illustrated in Figure 22. 3 other Member States (Austria, Czechia and Slovenia) processed an 
additional 20 to 30 requests, and 2 (Italy and Slovakia) processed an additional 1 to 19 requests. 
Of the 5 Member States who processed fewer requests than in the previous, Ireland processed 
45 fewer (a fall of 83%); the others 4 saw a fall of between 4 and 13 in requests processed. 

Figure 22. Comparison of number of requests for explicit consent processed by 

DNAs during the present period versus the previous period for those DNAs 
experiencing the greatest change. (% change shown in parentheses) 

As the Agency reported, of the 7 233 requests for explicit consent, 58% of the requests received 
responses, following either the initial request, the first or the second reminder  - a slight rise 
from  54% in  the previous period.  In 17% of cases,  the response  was received after the first 
reminder (see Table 20) and did not require a second reminder to be sent. The overall response 
rate  increased  by  4%  compared  to  the  previous  reporting  period,  and  even  though  it  still 

60 

 
 
 
 
remained rather low, the system of reminders – of which the vast majority were triggered and 
sent automatically - was considered effective and efficient. 

Table 20. Reminders for explicit consent requests sent by the Agency during the 

reporting period 

Year 

2020 

2021 

2022 

Total 

First reminder 

Second reminder 

1 679 

1 388 

1 718 

4 785 

1 201 

1 013 

1 196 

3 410 

During  the  reporting  period,  there  were  64  instances  across  five  Member  States  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 21). This compared with just 14 such instances during 
the previous period from two Member States (Germany and Spain).  

Table 21. Number of requests for explicit consent pursuant to Article 14(6)(b) 

Member State 

2020 

2021 

2022 

Total 

Germany 

Hungary 

Ireland 

Romania 

Slovenia 

1 

0 

1 

1 

10 

8 

0 

0 

0 

18 

10 

1 

0 

1 

13 

19 

1 

1 

2 

41 

Difficulties encountered in the implementation of the explicit consent procedure   
10 Member States reported having experienced difficulties in implementing the explicit consent 
procedure, three more than in the previous period. As in the previous report the main challenges 
reported  concerned  communication  with  DNAs  of  importing  countries.  In  general,  these 
concerned  difficulties  in  getting  in  contact  with  the  relevant  DNAs  and  lack  of  response  -
sometimes no response at all from certain countries even after multiple and explicit requests; 
responses which were inadequate either because they did not answer the question, were unclear, 
or provided irrelevant information; lack of understanding of the EU Regulation on the part of 
the  contacts  concerned.  In  addition,  certain  countries  imposed  additional  national  rules  that 
caused  further  delays.  One  Member  State  commented  that  implementation  of  the  explicit 
consent procedure remains the main challenge for both DNAs and industry too: “In many cases, 
the  DNAs  still  did  not  receive  answers  from  the  importing  country  and  the  60-day  waiting 
period is a significant burden for the industry to be able to request a waiver." 

Also mentioned were the difficulties of having to use websites indicated by the importing DNA 
to verify the possibility of export when this was available only in the domestic language. One 
Member State experienced some difficulties with the consents for biocidal products where the 
import  authorities  were  confused  with  the  pesticide  use  for  biocidal  products  and  for 
phytosanitary products. This arose mainly with Central American and Middle Eastern countries. 

To  improve  the  processing  of  requests  for  explicit  consent,  one  DNA  suggested  (as  in  the 
previous period) that it would be useful for processing DNAs to receive an email alert from 
ePIC indicating when responses to explicit consent requests had not been received after 30 and 
60 days. This would allow the DNA to advise companies in relation to waivers.   

61 

 
 
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 was working smoothly and that collaboration with DNAs in cases 
where the interpretation of the explicit consent is difficult was effective. An on-line workshop 
with  DNAs  was  organised  on  17  November  2021  on  the  explicit  consent  management. 
According to the feedback received from DNAs, defining the validity period and some specific 
restrictions (i.e. RIN-specificity, exporter-specificity) were the most challenging elements in 
the  interpretation  of  the  responses.  According  to  the  Agency,  the  process  contributed  to 
harmonised data and the reduction of clerical errors during the procedure.   

4.7.3  Waivers (Article 14(6) and (7))  
When an exporter submits a waiver request, their  Member State DNA checks it and, if they 
approve,  it  is  sent  to  the  Commission  for  final  verification/approval.  Once  approved,  the 
Agency will then be tasked to activate the related RIN(s) should there be any pending exports 
which match the criteria for the waiver. 

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.  

11 Member States (compared to 8 in the period 2017-2019, and 6 in the period 2014-2016) 
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 (Table 22). 

Five other Member State DNAs stated that they were not required to make a decision, and the 
remaining eleven indicated that they did not receive any such export notifications. No Member 
States reported difficulties in taking this decision. 

The number of cases varies greatly between these Member States. 6 Member States (DK, FI, 
EL, HU, PL and ES) reported a handful of cases (between 2 and 6). The other 5 reported in 
excess of 20 cases (BE, FR, DE, IT and SI). In the previous two periods the largest number of 
cases were reported by Italy (30 in the period 2017-2019, 49 in the period 2014-2016) and this 
continued  with  35  cases  in  the  present  period.  Belgium  at  32  and  France  at  28  experienced 
similar levels of cases. 

5 other Member State DNAs stated that they were not  required to  make  a decision, and the 
remaining eleven indicated that they did not receive any such export notifications. No Member 
States reported difficulties in taking this decision.  

Table 22. 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 

2020 

2021 

2022 

Total 

Belgium 

Denmark 

Germany 

Greece 

Spain 

France 

18 

2 

2 

2 

2 

12 

8 

0 

6 

0 

3 

14 

6 

1 

13 

0 

0 

2 

32 

3 

21 

2 

5 

28 

62 

 
 
Member State 

2020 

2021 

2022 

Total 

Italy 

Hungary 

Poland 

Slovenia 

Finland 

11 

2 

0 

0 

2 

11 

0 

3 

10 

4 

13 

0 

3 

11 

0 

35 

2 

6 

21 

6 

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. 

Fifteen Member States (compared to thirteen in the period 2017-2019, and eleven in the period 
2014-2016)  received  waiver  requests  in  accordance  with  Article  14(7)  during  the  reporting 
period (see Table 23). The number of waiver requests received by DNAs varies greatly between 
Member States, from  one request  in  Bulgaria to  333 in  Belgium (compared with  148 in  the 
previous period). Overall, the number of waiver requests has risen from 571 to 1 328. 

Table 23. Number of waiver requests received per Member State during the reporting 

period 

Member State 

2020 

2021 

2022 

Total 

Belgium 

Bulgaria 

Denmark 

Germany 

Greece 

Spain 

France 

Italy 

Hungary 

Netherlands 

Austria 

Poland 

Slovenia 

Finland 

Sweden 

Total 

167 

0 

8 

62 

13 

29 

111 

10 

14 

38 

1 

4 

10 

2 

13 

114 

0 

17 

34 

23 

36 

60 

13 

22 

96 

2 

7 

11 

2 

3 

52 

1 

16 

185 

0 

42 

23 

25 

7 

17 

0 

12 

11 

4 

11 

333 

1 

41 

281 

36 

107 

194 

48 

43 

151 

3 

23 

32 

8 

27 

482 

440 

406 

1 328 

Only one Member State stated that they experienced difficulties in implementing the waiver 
procedure and this concerned lack of response from the importing country.  

The Commission generally considered that the waiver procedure worked smoothly during the 
reporting period, and that collaboration with the DNAs was positive. However, the Commission 

63 

 
 
mentioned  that  the  quality  of  the  evidence  provided  by  exporters  to  demonstrate  that  the 
conditions of Article 14(7) are met could still be improved.  

The  Agency  considered  that,  overall,  the  process  was  working  smoothly  and  improvements 
were identified and implemented to address the inefficiencies reported during the two previous 
reporting periods. In particular, changes were introduced in ePIC to support a more efficient 
workflow. More specifically, the waiver submission wizard was updated to prompt companies 
to upload a mandatory cover letter explaining the nature/validity of the alternative evidence and 
a  translation  (when  necessary)  to  improve  the  quality/completeness  of  the  documentary 
evidence.  Flags  were  also  introduced  to  the  DNA  task  to  prevent  clerical  mistakes  and 
acceptance  of  standard  waivers  in  the  absence  of  an  explicit  consent  request.  The  whole 
workflow  was  made  transparent  so  that  the  different  stages  of  the  approval  process  is  now 
visible  to  companies.  In  addition,  the  waiver  factsheet  was  updated  to  better  describe  the 
conditions  and the required evidence/supporting documents, and a link to this factsheet  was 
included within the waiver submission wizard/tasks in ePIC. 

Although  further  clarifications/follow-up  actions  of  individual  cases  had  decreased,  the 
efficiency of the process could still be further enhanced. Additional IT improvements could be 
considered in both industry and authority tasks in ePIC, to further improve the quality of the 
evidence provided by companies and the identification of waiver conditions.  

4.7.4  Validity of explicit consent (Article 14(8))  
According to the procedure described in Article 14(8), 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.  

Ten Member States experienced cases where the export was allowed to proceed pending a reply 
to a new request for explicit consent (see Table 24). This compared with fourteen cases in the 
previous period.61 The total number of cases was 181 compared with 569 in the previous period. 
The highest number was reported by Belgium with 56 compared with 42 in the previous period. 
Cases in France fell from 193 in the previous period to 21, and Germany from 163 to 49. 

Table 24. 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 

2020 

2021 

2022 

Total 

Belgium 

Denmark 

Germany 

Greece 

Spain 

France 

Italy 

Hungary 

Poland 

Finland 

Total 

4 

0 

13 

0 

6 

5 

1 

0 

4 

0 

33 

15 

1 

11 

3 

9 

12 

0 

1 

4 

1 

57 

37 

1 

25 

1 

14 

4 

0 

0 

7 

2 

91 

56 

2 

49 

4 

29 

21 

1 

1 

15 

3 

181 

64 

 
 
The Agency reported no difficulties and that the majority of the cases were processed following 
standard workflows within ePIC. However, certain cases still required specific assessments and 
exchanges with the concerned Member States. This is marked improvement from the previous 
period when implementation of Article 14(8) was seen as challenging. This would indicate that 
the closer agreement between the Agency and DNAs  and the related  enhancements in  ePIC 
functionality, reported in the previous period, have borne fruit. 

Information on transit movement (Article 16)  

4.8 
None  of  the  Member  States  implemented  Article  16  during  the  reporting  period  as  in  the 
previous two reporting periods.  

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 three Member States reported compliance issues. Another 15 stated they 
had no issues, 5 said this not applicable, and 4 did not know. 

Compliance issues relating to packaging and labelling requirements   
The national enforcement authorities in three Member States (compared to six in the previous 
reporting exercise) experienced compliance issues concerning the information accompanying 
exported chemicals. In each case, the issues reported were different; CLP, BPR and in the other 
case it was an unspecified customs matter. By contrast, in the previous reporting exercise, five 
Member States reported issues linked to CLP. 

Compliance issues with the SDS and the language(s) of the label or SDS   
Only two 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 (one Member State) and on the SDS (one Member State).  

Compliance  issues  concerning  the  information and  packaging  requirements  linked  to  the 
exported products 
Finally,  only  one  Member  State  reported  experiencing  compliance  issues  regarding  the 
information  and  packaging  requirements  linked  to  the  exported  products.  This  concerned  a 
product containing a POP substance (mercury containing lamps) under Annex V. 

Enforcement of the PIC Regulation (Article 18)  

4.10 
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.   

65 

 
 
Article  18  states  that  Member  States  must  provide  information  on  the  activities  of  their 
enforcement authorities in their Article 22 reports. The questionnaire asked Member States to 
report  on:  the  organisation  of  enforcement  activities  at  national  level  and  their  enforcement 
strategy;  training  of  inspectors;  enforcement  actions  and  their  penalty  system;  collaboration 
between National Enforcement Authorities (NEA) and DNAs and Forum activities; and asked 
them  to  provide  data  on  the  enforcement  activities  and  infringements  observed  during  the 
reporting period.   

Information provided by the DNAs showed that all Member States had put in place a system to 
ensure  compliance  with  the  PIC  Regulation.  All  Member  States  had  nominated  authorities 
responsible for the enforcement of the PIC Regulation (in most Member States, this was the 
customs authority and the environmental/health inspectorate). Twelve Member States had put 
in place an enforcement strategy (including rules of procedures, written instructions, etc.), down 
from sixteen in the last reporting period.61 Some Member States indicated this was because the 
enforcement  was  in  place  and  did  not  require  development.  Twelve  Member  States  had 
established regular training of inspectors and some others include PIC as an occasional topic in 
general chemicals regulatory training. For the first time, a couple of Member States indicated 
that training was not carried out due to lack of resource or financial constraints.  

Seventeen 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 mostly positive.   

4.10.1  National enforcement authorities (NEAs)  
Most Member States had several authorities in charge of enforcing the PIC Regulation. Customs 
were  involved  in  the  implementation  of  the  PIC  regulation  in  all  Member  States  except 
Denmark, which was a change since the last reporting period. Malta did not involve customs in 
the past, whereas Denmark did. In 5 countries, the customs administration was the only NEA 
(Italy, Slovakia and Spain, Luxembourg, Sweden). In the previous reporting period, this was 
the case in 6 Member States62. Czechia, Poland, and Latvia previously had only the customs 
administration but  had  expanded  enforcement to  other authorities.  Conversely,  Luxembourg 
and Sweden had other enforcement authorities involved in the past and now no longer did.  

Enforcement  authorities  were  typically  environmental,  chemical  and/or  health  inspection 
services. In 9 Member States, the NEA was part of the same institution as the DNA. In almost 
all the Member States, authorities involved in the enforcement of the PIC Regulation were also 
typically involved in the enforcement of the CLP Regulation (24 Member States), the REACH 
Regulation (24 Member States), and the BPR (20 Member States). 13 Member States were also 
involved in enforcing PPPR. 

12 Member States (compared to 15 in the previous reporting period, and 18 in the first reporting 
period) indicated that NEAs had sufficient resources to carry out their obligations under the 
PIC Regulation,  while  10 (compared to  8 in  the  previous reporting period  and 7 in  the first 
reporting period) stated they do not have appropriate resources. Where reasons were given, they 
related to the lack of financial resources and lack of people, in particular in enforcement.  

4.10.2  Training inspectors   
12 Member States (compared to 16 in the previous reporting period and 15 in the first reporting 
period) indicated that inspectors were regularly trained on the PIC Regulation.61   Among the 
Member  States  that  had  organised  regular  training,  seven  mentioned  training  activities 

________________________ 
62 Czechia, Italy, Latvia, Poland, Slovakia and Spain. 

66 

 
 
addressed to inspectors, and three mentioned training activities addressed to customs’ officers. 
Seven stated that such training was included as part of general training on chemicals legislation. 
DNAs  mentioned  various  types  of  activities,  including  meetings,  workshops  and  specific 
training for new inspectors. 

Most Member States that had not organised regular training on the PIC Regulation explained 
either that training was done on a more ad-hoc basis (such as meetings, internal exchanges). 
Some said training was not carried out due to lack of resources / financial burden. Others said 
training had not been requested / was not necessary. Some said that training covered chemicals 
related  regulation  more  generally  and  PIC  was  only  occasionally  covered  or  had  not  been 
covered in this period. Some suggested EU level webinars and workshops, and mutual learning 
such as through  an enforcement expert group, for example using the  Forum for  Information 
Exchange on Enforcement.  

4.10.3  Enforcement strategy   
12 Member States reported having a strategy for the enforcement of the PIC Regulation, down 
from  15  in  the  previous  reporting  period.  61  8  Member  States  had  fully  implemented  their 
strategies.  3  Member  States  had  partially  implemented  their  strategies  and  one  was  just 
beginning. 2 Member States with partially implemented strategies did not have strategies in the 
previous reporting period. 

6 Member States had a strategy in the last reporting period and now no longer did. Of these 2 
explained that their existing processes worked well. 2 cited lack of funds as the reason, 1 said 
they planned to have a future strategy, and 1 said the organisation responsible for enforcement 
was not the correct organisation to determine strategy. 

Figure 23. Question 62. Does your authority (or any other relevant authority) have 

an enforcement strategy for Regulation (EU) No 649/2012?   

4.10.4  Enforcement activities   
During  the  reporting  period,  documentary  checks  were  carried  out  in  around  80%  of  the 
Member States (22). More than half investigate or conduct reactive inspections (i.e. of issues 
brought to the enforcement authority’s attention) or conduct proactive inspections. Fewer than 
half reported carrying out announced or unannounced inspections or on site checks (Figure 24).   

67 

 
 
 
 
 
 
Figure 24. Enforcement activities carried out in Member States 

8 Member States mentioned other enforcement activities, which were:   

•  Customs, Inspection and examination of documents, including: 

o  Verifying in the ePIC database the status of the RIN or special RIN for the exported 

chemicals, which exporters are obliged to provide in the export declaration; 

o  Controlling the compliance with packaging and labelling conditions, 
o  Checking the required documents, e.g. attaching the safety data sheet, 
o  Post-analysis of the previous year importations and contact/visits to  companies if 

considered necessary; 
•  Answering questions of companies; 
•  Proactive  ePIC  search,  such  as  analysis  of  previous  year  and  conducting  visits  if 

considered necessary; 
Inspection of companies on other chemical regulation (CLP, BPR, PPPR) might give 
rise to a PIC concern, which is then also investigated; 
Interaction with the DNA to assess if substances are biocides/PIC chemicals or not. 

• 

• 

One Member State said all possible methods could be used, but the method chosen depended 
on  the  situation.  Another  Member  State  referred  to  the  powers  provided  to  customs  in 
Regulation No. 952/2013 to indicate the powers available.63 

Table 25. Number of official controls on exports in which the PIC Regulation was 
covered or enforced during the reporting period, by Member State 

Member State 

Customs 

Inspectors 

Others 

Belgium 

Bulgaria 

Czechia 

Denmark 

Germany 

Estonia 

Ireland 

Greece 

Spain 

France 

1 820 

40 425 

N/A 

0 

3 

0 

35 

0 

42 168 

325 

30 

N/A 

N/A 

0 

45 

0 

0 

0 

0 

N/A 

N/A 

N/A 

N/A 

0 

0 

0 

0 

0 

N/A 

N/A 

________________________ 
63 Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code, 

https://eur-lex.europa.eu/eli/reg/2013/952/oj  

68 

 
 
 
Member State 

Customs 

Inspectors 

Others 

Croatia 

Italy 

Cyprus64 

Latvia 

Lithuania 

Luxembourg 

Hungary 

Malta 

Netherlands 

Austria 

Poland 

Portugal 

Romania 

Slovenia 

Slovakia 

Finland 

Sweden 

1 320 

220 

5 

65 

0 

0 

18 

N/A 

282 

N/A 

N/A 

1 512 

N/A 

1 180 

0 

3 930 

N/A 

0 

N/A 

5 

0 

0 

0 

82 

0 

42 

87 

N/A 

0 

10 

82 

0 

0 

N/A 

0 

N/A 

0 

N/A 

0 

0 

N/A 

N/A 

0 

N/A 

N/A 

0 

0 

0 

0 

N/A 

N/A 

In relation to the above table, various Member States provided explanations for their responses 
of N/A or zeroes: 

•  Austria indicated that  chemical  inspectors  and customs authorities check  compliance 
with  Regulation  (EU)  649/2012  in  course  of  their  routine  inspections,  but  numerical 
data on official controls by the customs authorities are not available.  

•  Greece indicated that 400 inspections are carried out every year, but they are not 

focussed on PIC.  

The following comments were provided against Table 25 above for exports, and Table 26 below 
for imports: 

•  Although  Poland  indicated  inspections  are  not  applicable,  the  Chief  Sanitary 
Inspectorate carried out controls at the end of 2021 and the beginning of 2022. There 
was no available information on how many controls were in each year. 60 companies 
were controlled against classification and labelling, SDS, and reporting under Article 
10 (import, export). It was not specified if the controlled companies were exporters or 
importers. There was no precise information from the National Revenue Administration 
about  export controls  covering PIC chemicals  because it  was impossible to  filter the 
amount of the above-mentioned controls in customs declaration systems. 
Ireland noted extensive inspections were carried out under CLP, BPR and PPPR, but 
not  specifically  for  PIC.  However,  any  issues  discovered  regarding  PIC  would  be 
investigated also. 
In  Romania,  the  customs  authority  did  not  carry  out  official  controls,  it  had  the 
competence  to  carry  out  customs  control  according  to  national  and  EU  legislation. 
According to the Agency project, REF-10 from 2022, the inspection plan was aimed at 
the integrated control of chemicals in products. 

• 

• 

________________________ 
64 Cyprus indicated the numbers are on average. 

69 

 
 
 
In Table 26 concerning imports, several Member States noted that there was no statistical data 
available on imports. One explained this was because there is no obligation for a notification 
for  import,  so  there  were  no  controls  for  import  by  Customs  or  Inspectors.  Inspections  on 
imports  by  Customs  and/or  REACH/CLP/POP/BPR  inspectors  were  only  required  for  the 
REACH/CLP/POP/BPR legislation. In addition: 

•  Bulgaria  noted  that  during  the  reporting  period,  inspectors  reported  178  inspections 
carried out in relation to imports. During the period, 12 non-conformities were identified 
according to the legislation. 

•  Portugal  noted  that  in  addition  to  the  individual  controls  undertaken  by  each 
enforcement  entity,  joint  controls  have  been  made  by  The  General  Inspectorate 
(IGAMAOT) and Customs. 

Table 26. Number of official controls on imports in which the PIC Regulation was 
covered or enforced during the reporting period, by Member State  

Member State 

Customs 

Inspectors 

Others 

Belgium 

Bulgaria 

Czechia 

Denmark 

Germany 

Estonia 

Ireland 

Greece 

Spain 

France 

Croatia 

Italy 

Cyprus65 

Latvia 

Lithuania 

Luxembourg 

Hungary 

Malta 

Netherlands66 

Austria 

Poland 

Portugal 

Romania 

Slovenia 

N/A 

N/A 

N/A 

0 

0 

0 

N/A 

0 

58 177 

0 

0 

46 

10 

0 

0 

0 

0 

N/A 

0 

N/A 

N/A 

1 066 

N/A 

0 

N/A 

178 

N/A 

0 

9 

0 

719 

0 

0 

N/A 

0 

N/A 

10 

81 

0 

3 

31 

N/A 

N/A 

N/A 

N/A 

25 

6 

20 

N/A 

N/A 

N/A 

0 

0 

0 

N/A 

0 

N/A 

N/A 

0 

N/A 

0 

N/A 

0 

0 

N/A 

N/A 

0 

N/A 

N/A 

40 

0 

0 

________________________ 
65 Cyprus: Numbers are on average 

66 Netherlands: Inspectors from another NEA were responsible for enforcing the PPR. If an import notification of 

PPR was received by the ILT, these colleagues would be informed. 

70 

 
 
Member State 

Customs 

Inspectors 

Others 

Slovakia 

Finland 

Sweden 

0 

N/A 

N/A 

0 

0 

N/A 

0 

N/A 

N/A 

As part of its report, the Agency provided estimates of the use of the ePIC customs interface by 
DNAs. They reported that users from 22 Member States consulted the application: 

•  1 Member State checked more than 2 000 individual notifications 
•  1 Member State checked ~1 000 individual notifications 
•  2 Member States checked between 600 and 700 individual notifications 
•  1 Member State checked ~275 individual notifications 
•  5 Member States checked between 100 and 200 individual notifications 
•  3 Member States checked between 50 and 100 individual notifications 
•  4 Member States checked between 10 and 50 individual notifications 
•  5 Member States checked less than 10 individual notifications 

Overall, the trend is that fewer checks were carried out using ePIC during this period compared 
to the previous period.  

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  25).  In  nearly  all  Member  States  (25), 
administrative measures / orders could be used by enforcement authorities to ensure compliance 
with  the  PIC  Regulation.  Two  thirds  of  Member  States  (18)  provided  written  advice,  and 
slightly over half of the Member States (16) indicated they can use verbal advice. Just under 
half (13) could seize, confiscate or destroy non-compliant products.    

Figure 25. Measures that can be taken by enforcement authorities to ensure 

compliance with the PIC Regulation 

Other measures mentioned by Member States (most common first) include: 

•  Notifying law enforcement, lawsuits and fines;  
•  Withdrawal of the goods from the market / sanctions; 
•  Does not clear customs / goods not released to the market; 
•  Discussions with the DNA and requirement to rectify deficiencies; 
•  Documentary controls; and 
•  Testing of goods. 

71 

 
 
 
 
4.10.6  Infringements during the reporting period  

Infringements found through Customs’ controls   
Seven Member States (compared to five in the previous reporting period and three in the first 
reporting  period)  reported  identifying  infringements  through  customs  controls  (Belgium, 
Bulgaria,  Croatia,  Finland,  France,  Italy  and  Latvia)  (see  Table  27).  The  number  of 
infringements was very low (0.3%, assuming no overlap between controls on exports and on 
imports67) compared to the number of customs controls performed.   

Table 27. Number of customs controls and infringements observed during the reporting 

period 

Member State 

Controls on exports 

Controls on imports 

Infringements found 

Belgium 

Bulgaria 

Germany 

Ireland 

Greece 

Spain 

France 

Croatia 

Italy 

Cyprus 

Latvia 

Hungary 

Netherlands 

Austria 

Poland 

Portugal 

Romania 

Slovenia 

Finland 

1 820 

40 425 

3 

35 

0 

42 168 

325 

1 320 

220 

5 

65 

18 

282 

N/A 

N/A 

1 512 

N/A 

1 180 

3 930 

N/A 

N/A 

0 

N/A 

0 

58 177 

0 

0 

46 

10 

0 

0 

0 

N/A 

N/A 

1 066 

N/A 

0 

N/A 

97 

255 

0 

0 

0 

N/A 

14 

41 

4 

0 

1 

0 

0 

N/A 

0 

0 

0 

0 

2 

Infringements found through Inspectors’ controls  
As  in  the  previous  reporting  period,  6  Member  States  (compared  to  9  in  the  first  reporting 
period) found infringements through controls carried out by inspectors (Table 28). The number 
of infringements compared to the number of controls varied greatly across the 6 Member States, 
but  was  generally  higher  compared  to  the  ratio  shown  above  for  customs  controls:  -  5.4%, 
assuming no overlap between controls on exports and on imports.67  

Infringements found through other controls  
Only  Spain  reported  infringements  found  via  controls  performed  by  other  authorities  (24  in 
total for the reporting period). 

________________________ 
67 As there may be overlaps between the numbers of controls performed on exports and imports this is evidently only an indicative figure useful 

for comparison. 

72 

 
 
Table 28. Numbers of controls carried out by inspectors and infringements observed 

during the reporting period 

Member State 

Controls on exports 

Controls on imports 

Infringements found 

Belgium 

Bulgaria 

Germany 

Ireland 

Croatia 

Cyprus 

Latvia 

Luxembourg 

Hungary 

Netherlands 

Austria 

Poland 

Portugal 

Romania 

Slovenia 

Finland 

Sweden 

30 

N/A 

45 

0 

0 

5 

0 

0 

82 

42 

87 

N/A 

0 

10 

82 

0 

N/A 

N/A 

178 

9 

719 

0 

10 

81 

3 

31 

N/A 

N/A 

N/A 

25 

6 

20 

0 

N/A 

5 

N/A 

26 

0 

0 

0 

21 

0 

11 

0 

16 

N/A 

0 

0 

0 

4 

N/A 

Types and numbers of infringements 
As shown in Table 29, the main category of infringement found by customs related to Box 44 
of the single administrative document not being properly completed (60 infringements) and the 
absence of a RIN (46 infringements).  

Table 29. Types and numbers of infringements of the PIC Regulation observed by 

customs during the reporting period 

Type of infringement 

BE 

FI 

FR 

HR 

LV 

ES 

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 in accordance with provisions (Article 19 (1)) 

Expiry date of the chemical 

Packaging provisions (Article 17(1)) 

Labelling provisions (Article 17(1)) 

Safety Data Sheets provisions (Article 17(3)) 

Language provisions (Article 17(4)) 

0 

0 

22 

5 

16 

0 

0 

0 

0 

0 

0 

0 

0 

1 

0 

0 

0 

0 

0 

0 

0 

0 

4 

0 

3 

0 

0 

0 

0 

0 

Other 

53 

168 

769 

0 

0 

0 

0 

41 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

170 

0 

0 

20 

4 

0 

0 

0 

0 

0 

0 

0 

________________________ 
68 Finland - Special-RIN requested after the export took place. 

69 France – Infringement to Customs Regulations. 

70 Latvia - In 2022, export was prohibited due to the inability to provide all requested information: documents (invoice, payment order, proof 
of sale of the goods) proving the change of ownership of the goods (from a UK company to NL), the contract between the consignor and 
the consignee, and proof of payment for the goods (if prepaid). 

73 

 
 
As shown in Table 30, the main category of infringements found by inspectors related to Safety 
Data  Sheets  provisions  (35  infringements)  and  the  absence  of  export  notification  for  the 
chemical (20 infringements).   

Table 30. Types and numbers of infringements of the PIC Regulation observed by 

inspectors during the reporting period 

Type of infringement 

AT  BE  BG 

FI  DE  HU 

LV 

PL 

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 in accordance with provisions (Article 19 
(1)) 

Expiry date of the chemical 

Packaging provisions (Article 17(1)) 

Labelling provisions (Article 17(1)) 

Safety Data Sheets provisions (Article 17(3)) 

Language provisions (Article 17(4)) 

Other 

1 

0 

0 

0 

0 

0 

0 

1 

13 

1 

0 

3 

1 

1 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

12 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

16 

2 

1 

4 

1 

0 

0 

0 

0 

0 

0 

0 

0 

9 

0 

0 

0 

0 

0 

0 

471 

172 

273 

0 

0 

0 

0 

0 

0 

0 

11 

10 

0 

0 

0 

0 

0 

0 

0 

0 

0 

5 

0 

0 

0 

4.10.7  Penalties 
In all Member States, administrative or criminal fines were applied in case of infringement of 
the PIC Regulation, which is higher than in the previous reporting period where 26 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.  Ten  Member  States  indicated  that  a 
penalty of imprisonment could be imposed on the most serious infringements.  

Figure 26. Penalties applied in case of infringement of the PIC Regulation 

________________________ 
71 Finland - Article 10 report on import not submitted in time (all 4 cases). 

72 Germany - Infringement due to the fact that Article 10 Report has not been generated. 

73 Hungary – Infringement of annual reporting provisions according to Article 10. 

74 

 
 
 
 
13  infringements  in  3  Member  States  led  to  penalties  during  this  period,  compared  to  29 
infringements in 3 Member States in the previous period, and compared to 13 infringements in 
4 Member States in the first reporting period (see Table 31).   

Table 31. Number of infringements that led to penalties during the reporting period 

Member State 

Number of infringements found 

Number of infringements that led to 
penalties 

Belgium 

Germany 

Latvia 

5 

26 

22 

4 

7 

2 

4.10.8  Collaboration between DNAs and NEAs  

Collaboration between DNAs and NEAs 
22 Member States (compared to 24 in 2017-201961) indicated that there is a regular exchange 
of information between the DNA(s) and enforcement authorities. 5 Member States stated that, 
as the DNA and the NEA are in the same institution or co-located, information sharing occurs 
easily, whenever necessary. 7 Member States indicated that regular information exchange and 
meetings  were  held  between  DNAs  and  NEAs,  while  5  mentioned  regular  exchanges  of 
information  through  email  to  contact  points,  or  following  procedures  provided  for  in  laws, 
agreements  or  guidelines.  8  mentioned  regular  exchange  and/or  meetings  with  customs 
authorities.  

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

•  Enhancing  information  exchange,  organising  seminars,  workshops  and/or  training  (3 

Member States). 3 Member States raised the same request in the last period.  

•  Establishing  communication  strategy  between  DNA  and  Enforcement  Authorities  (1 

Member State). 

•  Enhancing cooperation in the implementation of risk-based approach (1 Member State). 
•  Organising more regular meetings between DNA and Enforcement Authorities (1 Member 

State). 

In addition, two comments related to actions to be taken at EU level:   

•  An Enforcement Forum Project involving focus on Integrated Chemical Control of Products 

between REACH, CLP, BPR, PPP and PIC (1 Member State). 

•  EU-level webinars and workshops (1 Member State).  

Collaboration  between  DNAs  and  national  members  of  the  Forum  for  Exchange  of 
Information on Enforcement   
The  Agency’s  Forum  for  exchange  of  information  on  enforcement  (the  Forum)  provides  a 
platform for enforcement authorities to collaborate and share experiences on all of the chemical 
legislation covered by the Agency. 

23 Member States (1 more than in the previous reporting period61) indicated that there was a 
regular exchange of information between the DNAs and the national member(s) of the Forum. 
As was the case in the previous reporting period, 11 Member States explained that since the 
Forum member was also a member of the DNA, or was part of the same institution, regular 
exchanges of information occurred without formal communication/coordination mechanisms. 
5 Member States  indicated that there  were  regular exchanges of information, either through 

75 

 
 
 
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.  

In  Czechia,  a  National  Forum  for  Enforcement  facilitated  exchange  of  information  and 
coordination  of  joint  enforcement  projects  in  the  field  of  chemical  safety.  Members  of  the 
National  Forum  included  representatives  from  major  supervisory  authorities  and  other 
government  bodies  and  organizations  in  the  field  of  chemicals  (Czech  Environmental 
Inspection, State Labor Inspection Office, General Customs Directorate, Central Control and 
Testing Institute for Agriculture, State Health Institute, regional public health offices, Ministry 
of the Environment, Ministry of Health, Ministry of Industry and Trade). The National Forum 
was chaired by a member of the Forum for Exchange of Information on Enforcement at the 
European Chemicals Agency for the Czechia. 

Nearly  all  DNAs  stated  (24)  that  they  were  satisfied  with  the  collaboration  with  Forum 
members. Two Member States were not satisfied with the collaboration and made the following 
comments: 

•  Further improvement of the cooperation was needed. 
•  DNA was not aware of the discussions of the Forum, therefore they did not know if anything 

related with compliance of PIC was discussed there. 

4 Member States provided suggestions for improving collaboration between DNAs and Forum 
members which included suggestions regarding the above points:   

•  Regular  report  from  the  Forum  secretariat  at  the  DNA  meetings  should  continue  (one 
Member State).  The  Forum  Chairs and the Forum  Secretariat  (Harmonised Enforcement 
Team at the Agency) could take over such presentations, if indicated. 

•  Organisation  of  meetings  between  the  Forum  and  the  DNAs  to  discuss  enforcement 

(suggested online). 

•  Strengthen communication between the DNAs and Forum members generally.   
•  DNAs  could  be  invited  as  observers  to  the  Forum  meetings  under  the  agenda  points 

dedicated to the PIC Regulation. 

These suggestions are identical to previous report, except for the final bullet. 

4.10.9  Forum activities   

Specific actions 
No specific actions related to PIC enforcement were noted at the Forum during the reporting 
period, and none of the Forum projects during the reporting period mention PIC74. 

Regular exchange of information on coordination of enforcement 
The Agency reported that in 2020 the Forum addressed the requirement under Article 17 of the 
PIC  Regulation  that  the  SDSs  must  accompany  substances  and  mixtures  that  are  exported, 
where it is required for them. This was in context of discussing the requirements for availability 
of SDS at the moment of importation under REACH. 

In 2021 the Forum considered the proposal for an enforcement project on PIC duty for export 
notification  under  Articles  8  and  15.1  related  to  suspected  export  of  articles  containing 
substances listed in part 2 or 3 of Annex I to the PIC Regulation in unreacted form (i.e. lamp 
and batteries containing mercury, cadmium and potentially other substances). The project was 

________________________ 
74 https://echa.europa.eu/about-us/who-we-are/enforcement-forum/forum-enforcement-projects  

76 

 
 
ultimately not prioritised because the Forum considered there would not be sufficient number 
of duty holders in multiple Member States. In 2021 the Forum also asked the Commission for 
information  on  the  status  of  PIC  Article  22(2)  report.  Regular  exchange  of  information  on 
coordination of enforcement. 

The DNAs in 23 Member States reported participating in regular exchange of information with 
their country’s member(s) of the Forum, 4 did not. 

Opportunities for improvement of enforcement 
The  Agency  reported  that  the  Forum  considered  in  its  work  programme  2019-2023  that 
inspections of PIC duties should become part of the NEAs’ enforcement routine. 17 Member 
States indicated that their DNAs were satisfied with the activities carried out by the Forum. 
Nine Member States said that their DNA had no experience of Forum activities. One Member 
State said that their DNA was not satisfied with activities carried out by the Forum, because 
there was no periodic slot in the Forum Agenda on enforcement PIC issues; they said a recurring 
slot devoted to this issue would be desirable.  

6  other  Member  States  also  made  suggestions  for  improving  the  activities  of  the  Forum 
concerning the PIC Regulation: 

•  3  Member  States  underlined  the  benefits  of  pilot  projects,  such  as  the  one  conducted  in 
2018, and suggested that the Forum could organise similar pilot projects in the future.  
•  2 Member States suggested a project on harmonised enforcement, with one Member Stated 
indicating it could cover sharing of experience, training, producing a guideline, joint action 
and reporting. 

•  1 Member State suggested that when the scope of articles covered by the PIC regulation is 

clarified, it might be worth conducting a campaign on compliance with Article 15.1. 

•  1  Member  State  stated  that  they  supported  integration  of  PIC  considerations  into  the 

REACH Enforcement projects (REF) carried out by the Forum in future. 

Exchange of information (Article 20)  

4.11 
According to Article 20, the Commission, assisted by the Agency, and the Member States must 
facilitate  the  provision  of  scientific,  technical,  economic  and  legal  information  to  other 
countries on chemicals subject to the PIC Regulation, including toxicological, ecotoxicological 
and  safety  information.  Every  two  years,  the  Agency  must  compile  all  of  the  relevant 
information that has been transmitted.  

Information provided following ad-hoc requests  
In 2020 and 2021, the Agency received 11 ad-hoc requests falling within the scope of Article 
20,  from  9  non-EU  countries:  Togo  (2),  Sri-Lanka  (2),  Philippines,  Korea,  Gabon,  Kenya, 
Lebanon. Morocco and Burkina Faso. The details of the requests are described in the Article 
20 report covering the period 2020 – 2021.75 These requests related to the following topics: 

•  Questions  related  to  the  reason  for  listing  didecyldimethylammonium  chloride  and 
sodium dimethylarsinate, their scientific and regulatory background, and how to handle 
and dispose of these chemicals safely (Togo); 

•  Request for clarification on the EU procedures for exports for the substances not listed 

in Annex III to the Rotterdam Convention (Togo); 

•  Question related to the biocidal regulation in EU (Sri Lanka); 

________________________ 
75 Report on the exchange of information under the PIC Regulation 2020-2021: Compilation of information transmitted by the European 

Commission, Member States and ECHA under Article 20 of the PIC Regulation, , Reference: ECHA-22-R-05-EN, 
https://echa.europa.eu/documents/10162/1244645/pic_article_20_report_2020-2021_en.pdf, Section 4.2, page 16. 

77 

 
 
•  Question related to the labels for the products in the export notifications (Philippines); 
•  Request to receive a list with all the chemicals banned or restricted in the EU under the 

PIC Regulation and their regulatory background (Republic of Korea); 
•  Question related to the regulatory status of permethrin in the EU (Gabon); 
•  Question related to the import of diphenylamine from the EU, whether it falls under the 

EU PIC requirements or not (Kenya); 

•  Question related to the possibility of verifying the status of certain biocides in the EU 
and also in the EU Member State that appears as the place of manufacturing (Sri Lanka); 
•  Question  related  to  the  regulatory  status  of  treated  seeds  with  thiram  within  the  EU 

(Lebanon); 

•  Request to receive a list with all the banned or restricted pesticides in the EU (Morocco); 
•  Request related to the procedures for exports of chemicals that are not listed in Annex 

III to Rotterdam Convention (Burkina Faso). 

In 2022, the Agency received 7 enquiries, from Kenya (5), Jordan and South Africa. The nature 
and topic of these requests will be further elaborated in the next Article 20 report, covering the 
period  2022  –  2023,  which  is  due  by  the  end  of  2024.76  For  ease  of  reference,  links  to  the 
previous two reports 2016-201777, and 2018-201978 are provided in the relevant footnotes. 

Reporting on the information transmitted  
Every two years the Agency publishes 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 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. The report covering period 2020 – 2021 contained a new 
section (3) on information submitted through explicit consent responses to the Parties to the 
Rotterdam Convention or other countries. 

Technical assistance (Article 21)  

4.12 
Under  Article  21,  the  Commission,  DNAs  and  the  Agency  must  cooperate  in  promoting 
technical assistance, in particular to help developing countries and countries with economies in 
transition to implement the Convention and to develop the infrastructure, capacity and expertise 
necessary  to  manage  chemicals  properly  throughout  their  lifecycles.  In  addition,  the 
Commission and DNAs must actively participate in international activities in capacity building 
in chemicals management, and consider giving support to NGOs.   

The Agency and DNAs were asked to describe the activities in which they participated. The 
Agency 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: 

________________________ 
76 Report on the operation of the Prior Informed Consent (PIC) Regulation 2023, October 2023, 
https://echa.europa.eu/documents/10162/18272234/report_pic_art_22_2023_en.pdf, page 32.  

77 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/10162/1244645/pic_article_20_report_2016-2017_en.pdf/  

78 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:  https://echa.europa.eu/documents/10162/1244645/pic_article_20_report_2018-2019_en.pdf/  

78 

 
 
• 

• 

• 

• 

• 

In 2021, the Agency provided support to the Commission in the preparation and delivery 
of  three  regional  workshops  to  strengthen  the  capacity  of  parties  to  the  Rotterdam 
Convention. The online sessions were held in February, March and April in all three 
languages of the Convention.79  

In  April  2021,  the  Agency  also  participated  in  a  webinar  session  organised  by  the 
Rotterdam  Convention  for  the  Asian  Region80,  where  the  Agency  presented  the 
implementation of the Convention in the EU and clarified specific parts in the follow-
up Q&A session. The webinar also had the aim of strengthening collaboration between 
DNAs at national and regional level.  

In  June  2021,  the  Agency  provided  support  to  another  webinar  organised  by  the 
Rotterdam  Convention,  in  Arabic81  where  the  Agency  presented  and  answered  the 
follow-up questions.  

In February 2022, the Agency provided support to the Commission in the preparations 
and  delivery  of  a  workshop  organized  jointly  by  the  Russian  Federation  and  the 
the 
Secretariat  of 
implementation  of  the  Rotterdam  Convention  in  the  EU  and  provided  support  to  the 
follow-up Q&A session.   

the  Rotterdam  Convention,  where 

the  Agency  presented 

In May 2022, the Agency attended the 10th meeting of the Conference of the Parties to 
the Rotterdam Convention and, in cooperation with the Commission and some Member 
State  DNAs  and  the  Secretariat  of  the  Rotterdam  Convention  contributed  to  the 
preparations and delivery of five lunch hour regional group meeting82￼, in which over 
70 delegates from 37 non-EU countries participated. The aim was to clarify the specific 
provisions  of  the  EU  PIC  Regulation,  to  discuss  problematic  cases  and  to  gather 
feedback  from  the  authorities  in  the  non-EU  countries.  The  COP  is  an  excellent 
opportunity  for  approaching  delegations  from  non-EU  countries  (typically  the 
unresponsive ones) to refresh obsolete contact details, explain our procedures, clarify 
any specific misunderstandings and finally to identify ways and means to improve and 
further develop the information exchange and communication on hazardous substances 
that are exported from the EU to these countries.  

Some specific issues were raised by some of the importing countries, such as the lack 
of  accuracy  of  the  contact  details  of  importers  in  non-EU  countries,  the  very  high 
estimated  quantities  included  in  the  notification  form,  the  language  of  the  SDSs 
provided with the export notifications. There have been concerns raised also regarding 
the imports of part 1 chemicals for which the importing country sent a negative response, 
also possibility of the exporting/importing country of providing information regarding 
the  transit  country  within  the  export  notification.  It  has  been  noted  also,  as  in  the 
previous attendance to this event, the limited capacity in non-EU countries to respond 
to EU’s requests for explicit consent. The Agency also had one-to-one discussions with 
several  non-EU countries  authorities, in  particular with  the aim  of understanding the 
reasons  and  find  practical  solutions  to  the  issue  of  non-responsive  authorities  in  the 
importing countries.  

________________________ 
79 https://www.pic.int/Default.aspx?tabid=4215&meetId=124C5035-4565-EB11-8934-005056857856&lang=en  

80 https://www.pic.int/Default.aspx?tabid=4215&meetId=83549A86-3F86-EB11-8939-005056857856&lang=en  

81 https://www.pic.int/Default.aspx?tabid=4215&meetId=AF6C4951-81CE-EB11-927E-005056857856&lang=en  

82 One with the African group countries in English, and another with the African group (and other francophones) countries in French; one 
with the Asia-Pacific group countries in English; one with the Central and Eastern group countries in English and Russian; finally, one 
with the Latin American and Caribbean group countries in Spanish. 

79 

 
 
There was always good feedback from the importing countries regarding these events 
and it was mentioned that more support/training of this type would be appreciated.  

No Member States participated in cooperation activities during this reporting period, down from 
five  Member  States  in  the  previous  reporting  exercise.  Regarding  notifications  to  the 
Secretariat,  Member  States  were  always  consulted  on  drafts  and  provided  comments  in 
preparation of such notifications.  

Capacity-building activities  
Through  the  EU  Instrument  for  Pre-accession  assistance  (IPA),  the  Agency  continuously 
provided training and support to pre- and candidate countries to increase capacity in the area of 
chemical management. This included supporting beneficiaries’ efforts in aligning the provision 
of their national  regulation  regarding  the implementation of the Rotterdam  Convention with 
those in the EU.  

In addition, the Agency was involved in non-PIC-specific activities but which may cover the 
PIC  Regulation.  During  the  reporting  period,  the  Agency  finalised  two  in-depth  analyses, 
launched respectively in 2019 and 2020. These assessed the readiness and harmonisation with 
the EU acquis83 for chemicals management in 1) Montenegro and Serbia and 2) Albania, Bosnia 
and Herzegovina, Kosovo, North Macedonia and Turkey. The aim of the studies was to:  

Identify needs for support,  

• 
•  Map the actions required to fill existing gaps in capacity for these countries,  
•  Provide a better understanding of inter-dependencies between existing needs,  
•  Provide an understanding of cost and resources needed to fill those gaps.  

The outcome of the studies and national action plans are available on the Agency’s website.84   

No Member States carried out capacity building activities of this kind, down from four in the 
last reporting period.  

IT-related aspects  

4.13 
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 3 interfaces: for industry users, authority users (DNAs, the Commission, 
the Agency and enforcement authorities), and 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 identified some improvements to aid understanding 
and administrative efficiency. Answers to the questionnaire show that DNAs’ opinion on ePIC 
had improved since the previous reporting period and that more DNAs had 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 which were also identified by NEAs. All of the 

________________________ 
83 The European Union (EU) acquis is the collection of common rights and obligations that constitute the body of EU law, and is 

incorporated into the legal systems of EU Member States. 

84 https://echa.europa.eu/about-us/partners-and-networks/international-cooperation/support-to-eu-external-relations-policies/activities-under-

ipa/2020-2022  

80 

 
 
data that should have been made publicly available by the Agency according to the Regulation 
had been made available online.   

4.13.1  The ePIC system   
The  number  of  ePIC  users  from  industry,  DNAs  and  NEAs  increased  since  the  previous 
reporting period (see Table 32).   

Table 32. Number of ePIC users during the reporting period by type85 

Users 

Industry    

DNAs    

Commission   

NEAs   

2020-2022 

2017-2019 

4 924 

111 

2 

401 

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:   

• 

Integration of Article 10 non-confidential report generation within ePIC removing the need 
to use a separate tool outside of ePIC as was the case before. This reduced the Agency’s 
work in generating this annual report.  

•  Enhanced  messaging:  ePIC  was  integrated  with  the  common  communication  module 

(EDOMOD) together with new features:  
o  A  new  type  of  message  (“ad-hoc”)  was  introduced  to  reduce  the  need  to  contact 

exporters outside the system;  

• 

o  New search options for messages (message box - inbox and outbox);  
o  Alert and quick link to inbox in ePIC homepage for new messages.  
Improvements in waiver workflow to increase the efficiency of the process in response to 
various issues identified during the two previous reporting periods:  
o  A flag to DNA and Commission tasks was added to inform about the availability of an 

explicit consent response for the referenced export notification;  

o  A  cover  letter  and  a  translation  (where  relevant)  were  made  mandatory  supporting 

documents in addition to the original evidence in the industry wizard;  

o  A link to the fact sheet describing the waiver requirements was added in the tasks;  
o  the event history was updated to make the approval steps transparent to companies.  

•  Efficiency improvements in processing tasks:  

o  Bulk upload for the Agency record acknowledgement of receipts received from non-EU 

countries;  

o  Automated selection of  designated national  authorities in  both  DNA explicit consent 

and the Agency forwarding notification tasks;  

o  Automated  email  alerts  for  DNAs  to  flag  expiring  RINs  and  to  reduce  ‘manual’ 

monitoring of candidates for explicit consent renewals.  

•  Changes  in  chemicals  database  to  support  data  dissemination  and  to  facilitate  access  to 

reference data (legal context):  
o  Inclusion in Annex V was amended by introducing a display of parts 1 and 2;  
o  links  to legal  texts (so called “CELEX codes”) were added to  each chemical  in  both 

Annex I and V.  

________________________ 
85 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.   

81 

 
 
 
•  Adaptations following Brexit/Northern Ireland Protocol (NIP)  

o  The majority of the changes in relation to BREXIT were already developed during the 
previous reporting period and made available in October 2020 to allow companies to 
comply with Article 8 of the PIC Regulation;  

o  Further development was still required to adapt ePIC with Northern Ireland Protocol, 

those changes were also applied in October 2020.  

o  revocation  of  UK  companies’  and  authorities’  access  rights  took  place  on  1  January 

2021.  

• 

Improved searches:  
o  To increase the efficiency in  the authority processing  tasks, option to  filter authority 

tasks by Annex/part of the associated chemical was added;  

o  To identify submissions under Article 8(6) first sub-paragraph, search for special RIN 

requests was amended accordingly;  

o  Search of chemicals by Annex/part and use category.  

•  Change  of  forwarding  rules  and  the  threshold  alert  (10  kg)  for  special  RIN  requests  for 
group substances, to align the implementation with the approaches adopted in the 35th DNA 
meeting on 10 July 2020.  

•  Advance submission of Special RIN requests was enabled for chemicals introduced by a 

regulation amendment with entry into application date in the future.  

•  Article 10 improvements:  

o  A flag was introduced to highlight very large quantities reported by companies to reduce 

clerical mistakes;  

o  Insertion of manual entries by introducing a CAS/EC number.  

Additional information:  
The above-mentioned new/improved features  contributed to  a reduction of processing times 
and an increase in the overall efficiency of processes. They also enabled better traceability of 
cases  and  contributed  to  ensuring  consistency  and  reliability  of  the  data  in  the  system. 
Continuous  improvements  to  the  ePIC  submission  system  should  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. Lack of resources had however proven to be a limiting 
factor over the years.  

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  prioritised and implemented during the reporting 
period.   

In  their  reporting  questionnaires,  the  DNAs  were  also  generally  positive  about  the  user- 
friendliness  of  ePIC  in  carrying  out  their  main  obligations  under  the  PIC  Regulation. 
Comparison with results from the previous reporting show that (accounting for the UK DNA 
removal) DNAs’ opinion on ePIC has stayed the same and has dropped a little in relation to 
dealing with requests for explicit consent, and when dealing with other PIC procedures (Figure 
27).   

Exporters and importers 

According to the Agency, the feedback received from industry (representatives), for example 
in the margins of the DNA meetings, was mainly positive and some improvement proposals 
were prioritised for implementation (e.g. advance special RIN requests for chemicals not yet in 

82 

 
 
 
force, insertion of entries by CAS in Article 10 reports). Some comments and suggestions for 
further improvements were collected, such as: 

•  Providing the capability to  communicate with  DNAs and the Agency directly  within 

ePIC; 

•  Making usability improvements (e.g. duplicate functionality for special RIN requests, 
easier Article 10 creation, data insertion for Section 6.2. “Prohibited/Allowed uses”); 
and 

•  Enabling advanced submissions for chemicals contained in draft amendments (due to 

the short submission window following publication).  

Figure 27. Question 79. Is the ePIC system easy to use for DNAs? 

In addition, a usability study to capture user insights from the Agency’s IT tools was launched 
at the end of 2022 and the results will be analysed and reflected in the future development of 
ePIC. 

As in the previous reporting period, the feedback received by DNAs from industry users was 
also generally positive.  Over half of the Member States replied to this question (Figure 28), 
which  was  higher  than  in  previous  reporting  periods.  Responses  were  relatively  similar 
compared to the previous reporting period.  

•  1 Member State mentioned language issues as sometimes information or guidance is 
only available in English. This was also identified in the previous reporting period.  

•  2 Member States  reported that the method of attaching  or changing  already attached 
documents is not intuitive and this creates problems. An example is when a change of 
mixture needs recording against information generated in ePIC under manage mixtures 
(new SDS). The process to update is not easy. Also, SDS can only be entered if ending 
in “pdf”; even “PDF” does not work. These issues were also identified in the previous 
reporting period.  

•  1 Member State noted issues with account management: exporters have difficulties in 

changing/ updating account details. It is not clear where and how it can be done. 

83 

 
 
 
 
 
Figure 28. Question 80. Where possible, please provide feedback from exporters on 

the user- friendliness of the ePIC system.   

•  1 Member State said that after having added benzene >= 0.1%, the amount of actual 
benzene  imported/exported  can  only  be  guessed.  It  is  the  same  issue  with  UVCBs 
containing benzene in varying amounts. 

•  1 Member State mentioned Article 10 Reporting and said an interface/export to insert 

an Excel file is needed. 

•  A  Member  State  asked  if  it  could  be  possible  to  answer  the  replies  from  authority 
directly in ePIC. This would provide a message history in the tool, instead of having to 
step out of the system and send an email. They asked if e-mail exchange can be provided 
directly  in  ePIC  in  the  case  of  RIN.  It  was  also  important  to  enable  the  export 
automatically if DNA and the Agency both approve it, instead of having to wait 35 days 
for the status change in the platform. 

•  A Member State also requested that changes of Annexes I and V not be implemented 
during the year, but instead enter into force only on “First of January”. This is beneficial 
as reporting is required for the calendar year, which is problematic if the requirement 
starts part way through the calendar year. 

Customs authorities  
20 Member States reported that their customs authorities used ePIC, the majority of whom (14 
Member  States)  believed  that  customs  found  ePIC  easy  to  use  and  half  stated  that  customs 
considered it was an adequate tool to support them in controlling the application of the PIC 
Regulation (10 Member States). Others stated they had no information.  

According to the Agency, some Member States had expressed interest in automating the checks 
of export controls, and to integrate ePIC data to a centralised application (“Single Window”). 
This desire was also identified in the last reporting period. Feedback from the Commission to 
the Agency indicated that DG TAXUD also has an interest in integrating ePIC data to such a 
centralised Customs application. 

Other enforcement authorities   
10 Member States replied that, to their knowledge, other enforcement authorities were using 
ePIC (against 5 in the previous reporting) and 8 that they were not (against 6 in the previous 
reporting). 9 Member States did not have the information. Of the 10 Member States with other 
enforcement authorities using ePIC, eight replied that these enforcement authorities consider 

84 

 
 
 
ePIC easy to use. 7 replied, to their knowledge, these other enforcement authorities considered 
ePIC adequate to support them in their enforcement work.   

Other information or comments regarding data availability 
The  Agency  received  some  improvement  proposals  from  NEAs  during  the  reporting  period 
(through DNAs) related to data availability. Via the survey, 1 Member State indicated that a 
lack  of  open  data  created  a  significant  administrative  burden  in  responding  to  requests  for 
information  from  NGOs.    Another  Member  State  said  the  ePIC  system  did  not  provide  the 
ability to export and use detailed information from the notifications for the purpose of analysis 
for  risk-based  inspections.  The  export  dataset  lacked  details  of  the  exporters  and  importers 
(origin, destination, name and address); substance ID; an entry in the list of substances included 
in the Convention; product or tradename and intended use of the product (for example plant 
protection, chemical industry). 

4.13.3  Areas of ePIC improvement   
The main improvement needs/new functionalities for ePIC that the Agency were considering - 
pending availability of resources and budget - are listed below. In addition, there is a backlog 
which includes many small improvements which have been requested, mainly by DNAs and 
industry users: 

•  A  reporting  tool  for  DNAs,  to  enable  Member  States  to  prepare  various  reports 
concerning exports/imports independently and reducing ad hoc requests to the Agency 
(e.g. for ATD purposes);  

•  Further improvements to management of the chemicals database to increase efficiency, 

such as:  
o  Improved back-office functionality for amendments to ensure prompt publication of 

new entries;  

o  New  back-office 

functionality 

to 

create 

chemical 

specific  business 

rules/alerts/warnings  
(e.g. for dual use chemicals) to reduce manual verification;  

o  Submissions  for  certain  chemicals  in  articles  (which  are  otherwise  banned  for 

export).  

•  Change in the way acknowledgements of receipt are requested if it is decided that the 
current way of the process needs to be aligned with the provisions of the legal text.  

•  More  automation/simplification  of  processing  steps/tasks 

reduce  manual 
verification/steps  in  the  processing  (e.g.  partial/full  (pre-)validation  of  export 
notifications for Annex I, Part 1 substances, pre-filling/change of information in Section 
6.2 depending on policy decisions.  

to 

•  Further  improvements  in  the  waiver  workflow  (e.g.  standardised  cover  letters, 

transparency of case details).  

•  Any  potential  changes/improvements  following  developments  of  the  Commission’s 
initiative  to  ban  the  production  for  export  of  certain  hazardous  chemicals  and 
developments in the legal text.  

As regards the further development and maintenance of submissions systems, the Agency had 
started  transitioning  from  having  monolithic  end-to-end  regulation-specific  IT  systems  to 
solutions  made  of  small  reusable  regulation-agnostic  common  modules.  The  messaging  and 
access management modules in ePIC were already relying on such common modules and ePIC 
would likely follow this transition by gradually on-boarding to more of these modules. Overall, 
this should facilitate the maintainability, improve standardisation and bring synergies with other 
Agency applications. The transition to the new modules would bring opportunities to implement 
new  features  and  re-design  the  existing  functionalities  to  better  accommodate  the  needs, 

85 

 
 
 
including those highlighted above. This evolution might however, at some point in the future, 
require specific, additional resources; the Agency would keep the Commission informed about 
this project and discuss any resource needs if and when relevant.  

4.13.4  Data dissemination via the Agency Website  
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); and 

• 
•  Non-confidential data on explicit consents received from non-EU countries (Article 14).  

The Agency’s website section dedicated to PIC86 provided the following:  

•  Chemicals subject to PIC: the chemicals subject to PIC and listed in its Annex I (all 
Parts) or Annex V (all Parts), 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 in the EU, EU regulatory reference). 

•  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) are made available.   

• 

•  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  are 

• 

provided.  
Information on EU import responses under the Rotterdam Convention is also available 
in the form of an Excel sheet. 

In addition to the above, information on substances subject to the PIC Regulation was also made 
available  through  the  Agency’s  cross-regulations  dissemination  platform  (infocards,  brief 
profiles, and detailed source data). Reports on actual quantities of PIC chemicals exported and 
imported  (pursuant  to  Article  10)  for  each  year  of  the  reporting  period  can  be  found  here: 
https://echa.europa.eu/regulations/prior-informed-consent/annual-reporting-on-pic-exports-
and-imports.  Reports  on  information  exchange  (pursuant  to  Article  20)  can  be  found  here: 
https://echa.europa.eu/regulations/prior-informed-consent-regulation/reporting-on-
information-exchange . 

4.13.5  Improvements to the Agency’s PIC dissemination website 
An enhanced PIC dissemination platform went live in November 2022 to ensure a robust and 
sustainable  dissemination  of  the  PIC  data  and  a  better  integration  with  the  Agency’s  cross-
regulations dissemination platform.  

________________________ 
86 Chemicals subject to PIC: https://echa.europa.eu/information-on-chemicals/pic/chemicals  

86 

 
 
Based  on  the  results  of  a  consultation  with  stakeholders  and  an  analysis  carried  out  by  the 
Agency  in  2020,  the  following  information  was  made  available,  in  addition  to  what  was 
published already:  

•  Full regulatory context/history for Annex I and V chemicals, including links to legal 

acts;  

•  Chemicals not yet in force (added by amendment with entry into application date in the 

future);  
Information on Annex V chemicals by parts (part 1 and 2);  

• 
•  Foreseen use category for export notifications and explicit consents;  
• 
• 

Indication if an alias was provided for a mixture/article in export notifications;  
Information  on  PIC  chemicals  present  in  mixtures/articles  in  export  notifications 
(instead of displaying the mixture name only);  

•  Accepted waivers;  
• 

Indication if a country is Party to the Rotterdam Convention and/or member of OECD 
in DNA contact details section;  
•  Change dates in DNA contacts;  
•  All chemicals present in import notifications.  

In December 2022, information on EU import responses under the Rotterdam Convention were 
added  and  are  available  at  https://echa.europa.eu/eu-import-responses-under-the-rotterdam-
convention .  

Three reports on actual trade in 2019, 2020 and 2021 pursuant to Article 10 and two reports on 
information exchange covering periods 2018 - 2019 and 2020 – 2021 pursuant to Article 20 
were published during the reporting period. In addition, an update to the Article 20 report for 
2018 – 2019 was also made available. 

During the reporting period, the Agency published the second Report on the operation of the 
PIC  Regulation  (pursuant  to  Article  22)  in  2022  and  the  third,  which  covers  this  reporting 
period: Reporting on the operation of PIC Regulation 2023.87 

The report on information exchange for 2020 – 2021 (pursuant to Article 20) is available at 
Reporting on information exchange.88 The report for 2022-2023 is also available at this website. 

4.13.6  Agency PIC dissemination website feedback 
The Agency reported that overall the improvements compared to the previous portal had been 
appreciated. Further suggestions for improvement had been received as regards some search 
options and the data display (e.g. PIC chemicals should be displayed on the result table and not 
only in the details view).  

As regards the information made publicly available, in particular related to export notifications, 
some Member States had enquired whether more data on export notifications could be made 
available (e.g. company name, estimated quantity).  

________________________ 
87 https://echa.europa.eu/reports-on-the-operation-of-pic-regulation  

88 https://echa.europa.eu/regulations/prior-informed-consent-regulation/reporting-on-information-exchange  

87 

 
 
 
 
Annex 

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

88 

 
 
 
Table of contents 

1 

2 

INTRODUCTION 

The Agency’s budget 

INTERNAL WORK OF THE COMMISSION 
2.1 
Internal Organisation and Resources 
2.1.1  Resources 
2.1.2 
2.1.3  Coordination between the Commission and the Agency 
2.1.4  Coordination between the Commission and DNAs 
Policy work 
2.2.1  Amendments of Annexes I and V to the PIC Regulation 
2.2.2 
2.2.3  Guidance to Member States on the legal interpretation of the PIC 

EU import decisions 

2.2 

Regulation 

2.3 

Implementation and enforcement of the PIC Regulation 
2.3.1 
2.3.2 

Emergency situations (Article 8(5)) and waivers (Article 14(7)) 
Enforcement of the PIC Regulation 

Page 

92 

93 
93 
93 
94 
94 
94 
95 
95 
101 

102 
102 
102 
103 

3 

INTERNATIONAL WORK OF THE COMMISSION 
3.1 

103 
Preparation, coordination and submission of EU input to the Secretariat, the COP, 
103 
the CRC and other subsidiary bodies 
3.1.1  Representation of the EU to the Rotterdam Convention and coordination 

3.2 

3.3 
3.4 
3.5 

of EU input to the 10th and 11th Conferences of the Parties (CoP) to the 
Rotterdam Convention 
Participation in committees and expert groups 

3.1.2 
Communication  of  information  to  the Secretariat of  the Rotterdam Convention

103 
104 

3.2.1  Notification of FRA 
3.2.2  Communication of EU import responses 
3.2.3  Ad-hoc Secretariat requests 
Replies to requests for explicit consent received from other Parties 
Exchange of information (Article 20) 
Financial contribution to the Rotterdam Convention 

104 
104 
105 
105 
106 
106 
106 

89 

 
 
 
 
 
LIST OF TABLES 

Table 1. List of relevant documents consulted for the Commission report 
Table 2. Chemicals added to Annex I during the reporting period 
Table 3. Chemicals added to Part I of Annex V during the reporting period 
Table 4. Chemicals added to Part 2 of Annex V during the reporting period 
Table 5. EU import responses adopted during the reporting period 
Table 6. Implementation issues discussed at DNA meetings 
Table 7. Financial contributions from the EU to the Rotterdam Convention’s Trust Fund 

and Special Voluntary Trust Fund 

94 
98 
101 
102 
103 
104 

109 

90 

 
 
 
 
 
Abbreviations used 

Agency 

European Chemicals Agency 

BPR 

CAS 

CLP 

CN 

CoP 

CRC 

CUS 

DNA 

Biocidal Products Regulation 

Chemical Abstract Service 

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 

ECHA 

European Chemicals Agency 

ePIC 

EU 

FRA 

Software application for implementing Regulation (EU) No 649/2012  

European Union 

Final Regulatory Action 

ICSMS 

Information and communication system for the pan-European market surveillance 

NEA 

National Enforcement Authority 

NPs/NPEs  Nonylphenols and Nonylphenol Ethoxylates 

OECD 

Organisation for Economic Cooperation and Development 

PIC 

POPs 

PPPR 

Prior Informed Consent 

Persistent Organic Pollutants 

Plant Protection Products Regulation 

REACH   Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation 

RoHS 

Restriction of Hazardous Substances Directive 

RIN 

SDS 

WPIEI  

Reference Identification Number 

Safety Data Sheet 

Council Working Party on International Environmental Issues 
(Chemicals/Synergies) 

91 

 
 
INTRODUCTION 

1 
Article 22 of Regulation (EU) No 649/20121 (‘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 pursuant to 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 Agency under Article 22(1) concerning the operation 

of the PIC Regulation’s procedures.  

This reporting exercise for the period 2020-2022 is the third 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,  the  Agency’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.  

Note  on  Brexit:  With  the  departure  of  the  UK  from  the  EU  it  has  been  decided  by  the 
Commission to confine this exercise to the present 27 Member States.  

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

List of relevant documents consulted 

Implementing and delegated acts: 

•  Commission Delegated Regulation (EU) 2019/1701  

•  Commission Delegated Regulation (EU) 2020/1068 

•  Commission Implementing Decision (EU) 2020/2182 and its August 2021 correction 

•  Commission Delegated Regulation (EU) 2022/643 

•  Commission Delegated Regulation (EU) 2023/1656 

Associated report: 

•  Report from the Commission to the European Parliament and to the Council on the exercise of the delegation 
conferred on the Commission pursuant to 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. COM(2023) 448 final 

DNA meeting documents: 

•  Minutes of the DNA meetings that were held in 2020, 2021 and 2022 (respectively, the 35th, 36th, 37th, 38th, 39th, 

and 40th meeting of the DNAs). 

•  Any and all amendments to Annex I of the PIC Regulation as presented at the above meetings. 

________________________ 
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. https://eur-lex.europa.eu/eli/reg/2012/649/oj 

92 

 
 
List of relevant documents consulted 

•  Any import decisions presented at DNA meetings. 

• 

Submission of notifications to the PIC Secretariat, as presented at the 35th, 36th, 37th, 38th, 39th, and 40th DNA 
meeting.2 

Rotterdam Convention documents: 

•  Documentation relating to EU preparations for/actions arising from relevant Rotterdam Convention Conference 
of the Parties (COP) meetings, specifically CoP10 of 26-30 July 2021 and 6-17 June 2022, CoP11 of 1-12 May 
2023. 

• 

PIC  Circulars  published  by  the  Rotterdam  Convention  Secretariat  (six  were  published  during  2020-2022, 
Circulars LI to LVI).3 

The Agency’s reports on Article 20 and the Operation of the PIC Regulation: 

•  Report on the exchange of information under the PIC Regulation in 2020-20214 

•  Report on the exchange of information under the PIC Regulation in 2022-20235 

•  Report on the operation of the Prior Informed Consent (PIC) Regulation 20236 

CoP documents 

•  Council Decision (EU) 2022/1024 of 7 April 2022 on the position to be taken on behalf of the EU at CoP107 

2 

2.1 

INTERNAL WORK OF THE COMMISSION 

Internal Organisation and Resources 

2.1.1  Resources 
DG  Environment  is  in  charge  of  the  PIC  Regulation.  Unit  B.2  has  one  team  leader  for 
international chemicals responsible for carrying out the Commission’s administrative functions 
under PIC. The team leader 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  team  leader  and  a  policy  officer) 
nominated to the Chemical Review Committee of the Rotterdam Convention (CRC). The Head 
of Unit is also involved, in particular regarding the Conference of the Parties (CoP) where they 
normally lead the EU delegation and represent the EU. In addition, a policy officer from Unit 
B.2 is involved in the international work and colleagues from Unit F.3 (Global Environmental 
Cooperation  &  Multilateralism)  who  are  responsible  for  multilateral  environmental 
cooperation, contribute to its 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,  certain  legal  matters  and  the  technical  assistance 
contracts on implementation of the Rotterdam Convention. The staff resources occupied by this 
work amount to 0.4 FTE for the team leader, 0.3 FTE for policy officers/legal officers, and 0.1 
FTE for the supporting work, including international matters. 

________________________ 
2  As but one example, how to implement the (then new) listing of “benzene as a constituent of other substances” in Annex I Part 1 of the 

PIC Regulation was discussed in some of these meetings. 

3  https://www.pic.int/Implementation/PICCircular/tabid/1168/language/en-US/Default.aspx  

4  https://echa.europa.eu/documents/10162/1244645/pic_article_20_report_2020-2021_en.pdf  

5  Selected data supplied as a draft prior to publication. 

6  https://echa.europa.eu/documents/10162/18272234/report_pic_art_22_2023_en.pdf  

7  http://data.europa.eu/eli/dec/2022/1024/oj  

93 

 
 
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  2020-2022  was  set  by  the  Commission  as  part  of  its the  Multiannual  Financial 
Frameworks for the periods 2014-2020 and 2021-2027.  

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 the Agency under the PIC Regulation and developed several options for a fee system. 
The options included an assessment of the financial and technical feasibility and appropriateness 
of the options for the different stakeholder groups impacted (the Agency, 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. Taking into account the results of the study and 
the consultation of the Agency and Member States, the Commission decided not to submit a 
proposal.  

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 waivers8). 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.  

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

94 

 
 
 
 
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  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.  

During the reporting period 2020 to 2022, two Delegated Regulations amending Annex I were 
adopted: 

•  Commission Delegated Regulation (EU) 2020/10689 

•  Commission Delegated Regulation (EU) 2022/64310 

In  Commission  Delegated  Regulation  (EU)  2022/643,  there  were  sufficient  alterations  to 
existing  entries that the  whole of  Annex  I was substituted with  a replacement annex. These 
alterations were mainly necessary to update the customs codes provided in Annex I. 

Subsequent  to  this  reporting  period,  some  of  the  changes  being  considered  during  the  time 
period  were  implemented  in  the  subsequent  Commission  Delegated  Regulation  (EU) 
2023/1656 of 15 June 2023. As these substances were not added to Annex 1 or V during the 
2020 – 2022 time period they are not included in the tables below. 

Substances added to Annex 1  
Of the 48 substance entries added to Annex I during the reporting period: 

•  35  substances  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 

________________________ 
9 Commission Delegated Regulation (EU) 2020/1068 of 15 May 2020 amending Annexes I and V to Regulation (EU) No 649/2012 of the 

European Parliament and of the Council concerning the export and import of hazardous chemicals, (OJ L 234, 21.7.2020, p. 1–7). 
http://data.europa.eu/eli/reg_del/2020/1068/oj  

10 Commission Delegated Regulation (EU) 2022/643 of 10 February 2022 amending Regulation (EU) No 649/2012 of the European 

Parliament and of the Council as regards the listing of pesticides, industrial chemicals, persistent organic pollutants and mercury and an 
update of customs codes, (OJ L 118, 20.4.2022, p. 14–54). https://eur-lex.europa.eu/eli/reg_del/2022/643/oj 

95 

 
 
Regulation (EC) No 1107/2009 (PPPR), which represented a ban or severe restriction 
in  the  use  category  ‘pesticide’,  as  shown  in  Table  2  (basis  for  inclusion  is  noted  as 
‘PPPR’).  

•  1 substance was added to Parts 1 and 2 of Annex I following its non-approval for use 
in biocidal products in accordance with the BPR Regulation (EU) No. 528/2012. 

•  6  were  added  to  Parts  1  and  2  of  Annex  I  on  the  basis  of    the  REACH  Regulation 
because they were severely restricted or banned as industrial chemicals – 3 for public 
use, 3 for professional use.  

•  2  were  added  to  Parts  1  and  2  of  Annex  I  because  they  were  severely  restricted  as 

industrial chemicals under the POPs Regulation (EU) 2019/1021.  

•  Finally, 4 were included in Part 3 of Annex I following their inclusion in Annex III to 

the Rotterdam Convention (RC).  

Table 2. Chemicals added to Annex I during the reporting period  

Delegated Act 

Chemical name 

CAS number 

Amendment 
of Annex I 

Basis for 
inclusion 

Commission 
Delegated 
Regulation (EU) 
2020/1068 of 15 
May 2020  

Chlorothalonil 

Chlorpropham 

Clothianidin 

Desmedipham 

Dimethoate 

Diquat, including  

diquat dibromide 

Ethoprophos 

Fenamidone 

Flurtamone 

Glufosinate, including glufosinate-
ammonium 

1897-45-6 

Part 1 and 2 

101-21-3 

Part 1 and 2 

210880-92-5 

Part 1 and 2 

13684-56-5 

Part 1 and 2 

60-51-5 

Part 1 and 2 

2764-72-9 

85-00-7 

Part 1 and 2 

13194-48-4 

Part 1 and 2 

161326-34-7 

Part 1 and 2 

96525-23-4 

Part 1 and 2 

51276-47-2  

Part 1 and 2 

77182-82-2 

PPPR 

PPPR 

PPPR 

PPPR 

PPPR 

PPPR 

PPPR 

PPPR 

PPPR 

PPPR 

Hexabromocyclododecane 

25637-99-4,  

Part 3 

RC 

Imidacloprid 

Oxasulfuron 

Phorate 

Propiconazole 

Propineb 

Pymetrozine 

Quinoxyfen 

Thiamethoxam 

Thiram 

3194-55-6,  

134237-50-6,  

134237-51-7,  

134237-52-8  

and others 

138261-41-3 

Part 1 

144651-06-9 

Part 1 and 2 

PPPR 

PPPR 

298-02-2 

Part 1 and 3 

RC 

60207-90-1 

Part 1 

12071-83-9  

Part 1 and 2 

9016-72-2 

123312-89-0 

Part 1 and 2 

124495-18-7 

Part 1 and 2 

153719-23-4 

Part 1 and 2 

137-26-8 

Part 1 and 2 

PPPR 

PPPR 

PPPR 

PPPR 

PPPR 

PPPR 

96 

 
 
Delegated Act 

Chemical name 

CAS number 

Amendment 
of Annex I 

Basis for 
inclusion 

Commission 
Delegated 
Regulation (EU) 
2022/643 of 10 
February 2022 

2,4-Dinitrotoluene (2,4-DNT) 

4,4'-Diaminodiphenylmethane (MDA) 

121-14-2 

101-77-9 

Part 1 and 2 

REACH 

Part 1 and 2 

REACH 

2642-71-9 

Part 2 

71626-11-4 

Part 1 and 2 

PPPR 

PPPR 

71-43-2 

Part 1 

REACH 

Azinphos-ethyl 

Benalaxyl 

Benzene as a constituent of other substances 
in concentrations equal to, or greater than 
0.1% by weight. Except motor fuels subject 
to Directive 98/70/EC of the European 
Parliament and of the Council of 13 October 
1998 relating to the quality of petrol and 
diesel fuels (OJ L 350, 28.12.1998, p. 58). 
Part of EU combined nomenclature (CN) 
code 2707 10 00 

Beta-cyfluthrin 

Bifenthrin 

1820573-27-0 

Part 1 and 2 

82657-04-3 

Part 1 and 2 

Bis(pentabromophenyl) ether (decaBDE) 

1163-19-5 

Part 1 and 2 

PPPR 

PPPR 

POP 

PPPR 

Part 1 and 2 

Bromoxynil 

Cadmium and its compounds 

1689-84-5 

3861-41-4 

56634-95-8 

1689-99-2 

7440-43-9 

and others 

Part 2 

REACH 

PPPR 

PPPR 

BPR 

PPPR 

PPPR 

PPPR 

PPPR 

REACH 

Chlorpyrifos 

2921-88-2 

Part 2 

Chlorpyrifos-methyl 

5598-13-0 

Part 1 and 2 

Empenthrin 

Epoxiconazole 

Ferbam 

Fanamiphos 

Hexazinone 

Lead (Pb) and its compounds 

54406-48-3 

Part 1 and 2 

135319-73-2 

Part 1 and 2 

14484-64-1 

Part 2 

120068-37-3 

Part 1 and 2 

Part 2 

Part 1 

51235-04-2 

7439-92-1 

598-63-0 

1319-46-6 

7446-14-2 

7784-40-9 

7758-97-6 

1344-37-2 

25808-74-6 

13424-46-9 

301-04-2 

7446-27-7 

15245-44-0 

and others 

Mancozeb 

Mecoprop 

Mercury 

8018-01-7 

Part 1 and 2 

7085-19-0 

93-65-2 

Part 1 and 2 

PPPR 

PPPR 

7439-97-6 

Part 1 and 2 

REACH 

97 

 
 
Delegated Act 

Chemical name 

CAS number 

Amendment 
of Annex I 

Basis for 
inclusion 

Methiocarb 

Methomyl 

2032-65-7 

Part 1 and 2 

16752-77-5 

Part 2 

PPPR 

PPPR 

Commercial octabromodiphenyl ether, 
including hexa- and heptabromodiphenyl 
ether 

Commercial pentabromodiphenyl ether, 
including tetra- and pentabromodiphenyl 
ether 

36483-60-0 

68928-80-3 

40088-47-9 

32534-81-9 

Part 1 and 3 

RC 

Part 1 and 3 

RC 

Pentachlorophenol and its salts and esters 

87-86-5 

Part 1 and 3 

SC 

Perfluorooctanoic acid (PFOA), its salts and 
PFOA-related compounds 

and others 

335-67-1 

 and others 

Part 1 and 2 

POP 

Thiacoprid 

111988-49-9 

Part 1 and 2 

Thiophanate-methyl 

23564-05-8 

Part 1 and 2 

PPPR 

PPPR 

Entries of Annex I modified during the reporting period 
Commission Delegated Regulation (EU) 2022/643 of 10 February 2022 included a complete 
replacement of Annex I to Regulation (EU) No 649/2012 in order to update many entries to 
reflect  changes  to  classifications  of  these  chemicals  in  the  European  Union’s  Combined 
Nomenclature (CN). 

Substances removed from Annex I  
The following amendments are provided in Commission Delegated Regulation (EU) 2022/643 
amending Regulation (EU) No 649/2012:  

By Implementing Regulation (EU) 2017/150611, the Commission decided to renew the approval 
of the active substance maleic hydrazide under Regulation (EC) No 1107/2009, with the effect 
that maleic hydrazide and its choline, potassium and sodium salts are no longer banned for use 
in  the  subcategory  ‘pesticide  in  the  group  of  plant  protection  products’.  Therefore,  those 
substances were removed from the list of chemicals in Part 1 of Annex I to Regulation (EU) 
No 649/2012. 

The new entry on commercial octabromodiphenyl ether in Part 3 of Annex I to Regulation (EU) 
No 649/2012  also  covers  the  substance  octabromodiphenyl  ether  listed  in  Parts  1  and  2  of 
Annex I to that Regulation. Therefore, octabromodiphenyl ether was removed from the lists of 
chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012. 

Dicofol is a new listing in Part 1 of Annex V. Since a listing in Part 1 of Annex V to Regulation 
(EU) No 649/2012  prohibits  the export of a substance without any exemption, the listing  of 
dicofol in Parts 1 and 2 of Annex I to that Regulation is no longer required and was removed. 

________________________ 
11 Commission Implementing Regulation (EU) 2017/1506 of 28 August 2017 renewing the approval of the active substance maleic hydrazide 

in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant 
protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 222, 
29.8.2017, p. 21). 

98 

 
 
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  POPs  Regulation 
(Regulation (EC)  850/200412, replaced in 2019 by Regulation (EU)  2019/102113). 

inclusion  of  a  substance 

in  Annex  I 

the 

to 

During the reporting period, the following substances were added to Part 1 of Annex V. 

Table 3. Chemicals added to Part I of Annex V during the reporting period  

Legal Act 

Commission 
Delegated 
Regulation (EU) 
2022/643 of 10 
February 2022 

Chemical name 

CAS number 

Dicofol is prohibited for export without any exemption 

115-32-2 

Perfluorooctane sulfonic acid (PFOS), its salts and perfluorooctane sulfonyl 
fluoride. 

The export ban does not apply when PFOS, its salts and perfluorooctane 
sulfonyl fluoride is used as a mist suppressant for non-decorative hard 
chromium (VI) plating in closed loop systems. 

1763-23-1, 2795-
39-3, 70225-14-8, 
56773-42-3 and 
others 

Pentachlorophenol and its salts and esters 

Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds as 
regards its presence in fire-fighting foams. The export ban only applies to 
fire-fighting foam that contains or may contain PFOA, its salts and PFOA-
related compounds. 

Decabromodiphenyl ether 

87-86-5 and others 

335-67-1 and others 

1163-19-5 and 
others 

Changes to Part 1 of Annex V 
The  entry  covering  articles  containing  concentrations  of 
tetra,  -penta-,  hexa-  and 
heptabromodiphenyl ether at or above 0.1% by weight when produced partially or fully from 
recycled  materials  or  materials  from  waste  prepared  for  re-use  has  been  amended  by 
Regulation (EU) 2019/1021,  reducing  the  allowed  concentrations  in  articles  and  adding 
decabromodiphenyl ether. 

A number of classifications of chemicals  in  the European Union’s Combined Nomenclature 
have  been 
to 
Regulation (EU) No 649/2012. Those changes have been reflected in the Annex. 

chemicals  were 

to  Annex 

changed 

added 

those 

since 

I 

Part 2 of Annex V 
Part 2 of Annex V to the PIC Regulation lists chemicals subject to export ban other than POPs.  

Commission  Delegated  Regulation  (EU)  2022/643  of  10  February  2022  adds  the  export  of 
mercury,  certain  mixtures  of  metallic  mercury  with  other  substances,  certain  mercury 
compounds  and  certain  mercury-added  products  to  Part  2  of  Annex  V  to  Regulation  (EU) 
No 649/2012, in line with Regulation (EU) 2017/852. 

________________________ 
12 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. 

13 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.  

99 

 
 
Table 4. Chemicals added to Part 2 of Annex V during the reporting period  

Legal Act 

Commission 
Delegated 
Regulation (EU) 
2020/1068 of 15 
May 2020 

Chemical name 

CAS number 

Additions to entry 3: The following mercury compounds except where they are 
exported for laboratory-scale research or laboratory analysis: 

Mercury (II) sulphate (HgSO4);  

Mercury (II) nitrate (Hg(NO3)2). 

7783-35-9,  

10045-94-0 

Commission 
Delegated 
Regulation (EU) 
2022/643 of 10 
February 2022 

New entry 5: Compact fluorescent lamps (CFLs) for general lighting purposes:  

n/a 

(a) CFL.i ≤ 30 watts with a mercury content exceeding 2,5 mg per lamp burner;  

(b) CFL.ni ≤ 30 watts with a mercury content exceeding 3,5 mg per lamp burner. 

New entry 6: The following linear fluorescent lamps for general lighting 
purposes:  

n/a 

(a) Triband phosphor < 60 watts with a mercury content exceeding 5 mg per 
lamp;  

(b) Halophosphate phosphor ≤ 40 watts with a mercury content exceeding 10 mg 
per lamp. 

New entry 7: High pressure mercury vapour lamps for general lighting purposes. 

n/a 

New entry 8: The following mercury-added cold cathode fluorescent lamps and 
external electrode fluorescent lamps for electronic displays:  

n/a 

(a) short length (≤ 500 mm) with mercury content exceeding 3,5 mg per lamp;  

(b) medium length (> 500 mm and ≤ 1 500 mm) with mercury content exceeding 
5 mg per lamp;  

(c) long length (> 1 500 mm) with mercury content exceeding 13 mg per lamp.’.  

New entry 9: Batteries or accumulators that contain more than 0,0005% of 
mercury by weight. 

New entry 10: Switches and relays, except very high accuracy capacitance and 
loss measurement bridges and high frequency radio frequency switches and 
relays in monitoring and control instruments with a maximum mercury content 
of 20 mg per bridge, switch or relay. 

New entry 11: Cosmetics with mercury and mercury compounds, except those 
special cases included in entries 16 and 17 of Annex V to Regulation (EC) No 
1223/2009 of the European Parliament and of the Council of 30 November 2009 
on cosmetic products (OJ L 342, 22.12.2009, p. 59). 

New entry 12: Pesticides, biocides and topical antiseptics that contain mercury 
or a mercury compound that was intentionally added. 

New entry 13:   

The following non-electronic measuring devices that contain mercury or a 
mercury compound that was intentionally added: 

n/a 

n/a 

n/a 

n/a 

n/a 

(a) barometers; 

(b) hygrometers; 

(c) manometers; 

(d) thermometers and other non-electrical thermometric applications; 

(e) sphygmomanometers; 

(f) strain gauges to be used with plethysmographs; 

(g) mercury pycnometers; 

(h) mercury metering devices for determination of the softening point. 

This entry does not cover the following measuring devices: 

— non-electronic measuring devices installed in large-scale equipment or used 
for high precision measurement where no suitable mercury-free alternative is 
available; 

— measuring devices more than 50 years old on 3 October 2007; 

— measuring devices which are to be displayed in public exhibitions for cultural 
and historical purposes. 

100 

 
 
 
 
 
2.2.2  EU import decisions  
Article  10  of  the  Convention  requires  Parties  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  EU  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 2020 and 
a correcting Implementing Decision in 2021. 

The  2020 
implementing  decision  provided  new  import  decisions  for  phorate  and 
hexabromocyclododecane  (HBCDD).  Modified  decisions  were  provided  for  commercial 
pentabromodiphenyl ether, commercial octabromodiphenyl ether, and PFOS. 

The 2021 correcting Decision confirmed that the import decision for azinphos-methyl continues 
to apply after mistakenly being omitted in Implementing Decision (EU) 2020/2182. 

Table 5. EU import responses adopted during the reporting period 

Implementin
g Act* 

(EU) 2020/2182 
of 18 December 
2020 

Chemical names 

CAS 
number 

Nature / 
status of 
decision 

Import 
decision 

Grounds for 
decision 

Phorate 

298-02-2 

New decision 
/ Final 

No consent to 
import 

Banned for use by 
PPPR 

New decision 
/ Final 

No consent to 
import 

Banned for use by 
POPs Regulation 

Hexabromo-
cyclododecane 

Commercial 
Pentabromo-diphenyl 
ether including  

- tetrabromo-diphenyl 
ether  

- Pentabromo-
diphenyl ether 

Commercial 
octabromo-diphenyl 
ether including: 
Hexabromo-diphenyl 
ether Heptabromo-
diphenyl ether 

Perfluorooctane 
sulfonic acid, 
perfluorooctane 
sulfonates, 
perfluorooctane 
sulfonamides and 
perfluorooctane 
sulfonyls (PFOS) 

134237-50-6, 
134237-51-7, 
134237-52-8, 
25637-99-4,  

3194-55-6 

40088-47-9,  

32534-81-9 

Modified 
decision / 
Final 

36483-60-0, 

68928-80-3 

Modified 
decision / 
Final 

Modified 
decision / 
Final 

1763-23-1,  

2795-39-3, 

29457-72-5, 

29081-56-9, 

70225-14-8, 

56773-42-3, 

251099-16-8, 

4151-50-2, 

31506-32-8,  

1691-99-2, 

24448-09-7, 

307-35-7 

Exemption for 
continued use for 
spare parts /upgrade 
in certain Electrical 
and Electronic 
Equipment (EEE) 
provided by RoHS 
Directive 

Exemption for 
continued use for 
spare parts /upgrade 
in certain EEE 
provided by RoHS 
Directive 

Banned for use by 
POPs Regulation - 
specific derogation 

Consent to 
import only 
subject to 
specified 
conditions 

Consent to 
import only 
subject to 
specified 
conditions 

Consent to 
import only 
subject to 
specified 
conditions 

* Commission Implementing Decision 

101 

 
 
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 
various implementation issues (see Table 6). 

Table 6. Implementation issues discussed at DNA meetings 

DNA Meeting 

Implementation issued discussed 

35th – July 2020 

Application of the provisions of the PIC Regulation to Annex I group entries. 

Export of PIC substances as impurities of non-PIC substances. 

Use of ePIC mixture template for the notification of exports of NPs/NPEs. 

36th – November 
2020 

Metallic mercury under the PIC Regulation. 

Labelling trigger for non-hazardous mixtures. 

Approach for the recording of import notifications with several final destination countries. 

37th – April 2021 

Use category when notifying pesticides to be (primarily) used in industrial settings in the 
importing country. 

Definition of an article under PIC. 

Approach for the implementation of the new PIC Annex I entry for “Benzene as a constituent of 
other substances in concentrations equal to, or greater than 0,1% by weight”. 

38th – October 2021 

Approach for notifying treated/coated seeds. 

39th – April 2022 

PIC Regulation and exports to Russia and Belarus with regard to sanctions and dual-use items. 

Shortage of containers and fulfilment of PIC obligations. 

Amendments to the PIC Regulation and existing export notifications. 

40th – October 2022 

Legal entity change, asset transfer and company name change. 

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

Two  matters  concerning  Article  14(7)  were  addressed  during  the  reporting  period.  One 
concerned the operation of ePIC regarding searching for PIC chemicals. The other concerned 
modification of the “In brief” fact sheet on waivers. 

102 

 
 
 
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. No specific actions related to enforcement have been 
noted during the reporting period. 

INTERNATIONAL WORK OF THE COMMISSION 

3 
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 of the Rotterdam Convention 
(CRC), and other subsidiary bodies of the CoP. 

•  Submission  to  the  Secretariat  of  relevant  FRA  notifications  concerning  chemicals 

qualifying for PIC notification. 

•  Transmission of information concerning other FRA involving chemicals not qualifying 

for PIC notification. 

•  Submission to the Secretariat of EU 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  

3.1.1  Representation of the EU to the Rotterdam Convention and coordination of EU 
input  to  the  10th  and  11th  Conferences  of  the  Parties  (CoP)  to  the  Rotterdam 
Convention 

During the reporting period, the Commission represented the EU at the 10th CoP, which took 
place from 26 to 30 July 2021 (online segment which dealt with operational matters only), and 
from 6 to 17 June 2022 (face-to-face segment which dealt with technical matters). Preparation 
for the 11th CoP which took place from 1 to 12 May 2023 also occurred so is reported here. 

CoP-10  
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: 

to 

•  Proposal for a Council Decision establishing the position to be adopted on behalf of the 
European Union within the Conference of the Parties as regards amendments of Annex 
to  add 
III 
decabromodiphenyl ether (decaBDE) and perfluorooctanoic acid (PFOA), its salts and 
PFOA related compounds to Annex III. This proposal was adopted and submitted to the 
Council on 20 April 2021. 

the  Rotterdam  Convention.  This  concerned 

the  proposal 

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. 

103 

 
 
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-10, the Commission presented the outcomes of the CoP to DNAs at the 40th DNA 
meeting on 20 October 2022. As regards listing of additional chemicals in Annex III, out of 7 
chemicals only 2 had been listed; decabromodiphenyl ether (decaBDE) and perfluorooctanoic 
acid (PFOA), its salts and related compounds. 

CoP-11 
In preparation for the CoP, which occurred after the present reporting period, the Commission 
prepared and consulted with the Member States on the position of the EU on matters discussed 
at the meeting concerning: 

•  Two new candidates for listing in Annex III that would be on the agenda, based on the 
recommendation of the CRC - iprodione and terbufos. The position to be taken on behalf 
of the EU at the COP as regards their listing would be laid down in a Council Decision, 
which  would  be  based  on  a  Commission  proposal.  The  EU  and  its  Member  States 
position on all other agenda items that will be addressed at the CoP would be discussed 
in WPIEI and laid down in an EU-MS position paper. 

Participation in committees and expert groups  

3.1.2 
Members  of  the  Commission  participated  as  experts  in  the  CRC,  along  with  experts  from 
Member States as follows:  

•  1 May 2018 until 30 April 2022 – a Commission official was nominated by Malta. 

•  Since 1 May 2020 – a Commission official was nominated by Austria. That official also 

acted as member of the bureau of the CRC. 

3.2 

Communication of information to the Secretariat of the Rotterdam Convention  

3.2.1  Notification of FRA  
Under  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 the Agency, drafts the notifications, which 
are submitted to DNAs and observers for comments before being submitted to the Secretariat. 
Twenty-nine notifications were submitted to the Secretariat during the reporting period:14  

•  5-tert-butyl-2,4,6-trinitro-m-xylene (Musk xylene) (2022) 
•  Arsenic pentoxide (2022) 
•  Benzyl butyl phthalate (2022) 
•  Chlorothalonil (2021) 
•  Chlorpropham (2021) 
•  Chlorpyrifos (2022) 
•  Cybutryne (2020) 
•  Diisobutyl phthalate (2020) 
•  Dimethoate (2021) 
•  Diquat (2021) 
•  Ethoprophos (2021) 

________________________ 
14 https://www.pic.int/Countries/CountryProfiles/tabid/1087/language/en-US/Default.aspx, select region European Union, select tab 

submissions to see a list of “Notifications of Final Regulatory Action - Non-Annex III Chemicals” 

104 

 
 
•  Fenamidone (2022) 
•  Flupyrsulfuron (2020) 
•  Flurtamone (2022) 
• 
Isoproturon (2020) 
•  Linuron (2020) 
•  Mancozeb (2022) 
•  Mercury (2022) 
•  Methiocarb (2022) 
•  Oxasulfuron (2022) 
•  Propineb (2022) 
•  Pymetrozine (2022) 
•  Tepraloxydim (2022) 
•  Thiamethoxam (2022) 
•  Thiram (2022) 
•  Triasulfuron (2020) 
•  Triclosan (2020) 
•  Tricyclazole (2020) 
•  Tris(2-chloroethyl) phosphate (2020) 

3.2.2  Communication of EU import responses 
In line with Article 10 of the Rotterdam Convention and Article 13 of the PIC Regulation, the 
Commission communicated the formally adopted EU import decisions to the Secretariat of the 
Rotterdam Convention. The following final import decisions were submitted and published on 
the Convention website:15 

•  Commercial pentabromodiphenyl ether (including tetra- and pentabromodiphenyl ether)  
•  Commercial octabromodiphenyl ether (including hexa- and heptabromodiphenyl ether) 
•  Hexabromocyclododecane  
•  Perfluorooctane 
sulfonic 

perfluorooctane 

perfluorooctane 

sulfonates, 

acid, 

sulfonamides and perfluorooctane sulfonyls (PFOS) 

•  Phorate. 

3.2.3  Ad-hoc Secretariat requests  
The Commission replied to a number of information requests from the Rotterdam Convention 
Secretariat by collecting, compiling and submitting the requested information as follows: 

• 

information  exchange  (i.e. 
Information  on  exports,  export  notifications  and 
implementation of paragraph 2 of Article 11 and Articles 12 and 14 of the Convention); 

•  Data on international trade in chemicals listed in Annex III or recommended for listing; 

• 

Information on the measurable impact of listing in Annex III; 

•  Data on synergies  in  preventing and combating  illegal  traffic  and trade in hazardous 

chemicals and wastes.  

• 

Information on international trade in chemicals subject to review by the CRC. 

________________________ 
15 https://www.pic.int/Procedures/ImportResponses/Database/tabid/1370/language/en-US/Default.aspx, select tab submissions to see a list of 
“Import Responses by Party” and enter European Union. See also Commission Implementing Decision (EU) 2020/2182 of 18 December 
2020 (C(2020) 8977), https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32020D2182  

105 

 
 
In  addition,  the  Commission  has  submitted  comments,  agreed  in  WPIEI,  on  the 
recommendations from the CRC for amending Annex III to the Rotterdam Convention to be 
considered at CoP-10 on behalf of the EU. In that reply, the EU supported the listing of all 
chemicals that were recommended for listing by the CRC. 

The  Commission  also  provided  ongoing  technical  assistance  projects  with  the  Secretariat 
throughout this reporting period. 

Replies to requests for explicit consent received from other Parties 

3.3 
The PIC Regulation does not provide any specific rules for cases where an exporting non-EU 
country  requests  the  explicit  consent  of  the  EU  for  the  export  of  a  chemical  to  the  EU. 
Nevertheless, the Commission, acting as the designated authority of the EU, responds to such 
requests by establishing a reply on behalf of the EU to the non-EU country. 

Therefore, when an exporting non-EU country submits an export notification with a request for 
explicit consent to the Commission, asking whether the EU consents to the export of a chemical 
to the EU, a reply is provided by the Commission after consultation of the Member States. 

The  export  notification  is,  as  usual,  processed  by  the  Agency,  which  includes  sending  an 
acknowledgement of receipt of the export notification to the notifying non-EU country (unless 
otherwise preferred by the importing country). If a Member State receives an export notification 
together with a request for explicit consent, it forwards the request and the corresponding export 
notification to the Commission and the Agency for processing. 

During the reporting period, the EU submitted 41 explicit consent responses to parties to the 
Rotterdam Convention or other countries. In 40 of these cases the exporting country was the 
UK, in the other it was Burkina Faso.16 

Exchange of information (Article 20)  

3.4 
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 
toxicological, 
countries  about  chemicals  subject 
ecotoxicological and safety information. 

the  PIC  Regulation, 

including 

to 

During  the  period  2020-2022,  the  Commission  did  not  receive  any  ad-hoc  requests  falling 
within the scope of Article 20 of the PIC Regulation.16 

Financial contribution to the Rotterdam Convention  

3.5 
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 7). 

On  its  contribution  to  the  Special  Voluntary  Trust  Fund,  the  Commission  works  with  the 
Secretariat  of  the  Convention  to  specify  the  content  of  the  projects  to  be  carried  out  in 
cooperation with the beneficiary Parties. Those projects aim to assist Parties that are developing 
countries or countries with economies in transition, in order to improve the implementation of 
the Convention. The money paid into the Special Voluntary Trust Fund during this period was 
for projects that were based on the programme of work adopted by COP-9 in 2019. 

________________________ 
16 Report on the exchange of information under the PIC Regulation in 2020-2021, October 2022, 

https://echa.europa.eu/documents/10162/1244645/pic_article_20_report_2020-2021_en.pdf, page 16  

106 

 
 
Table 7. Financial contributions from the EU to the Rotterdam Convention’s Trust 

Fund and Special Voluntary Trust Fund 

Year 

EU Contribution to Trust Fund 

EU contribution to special voluntary trust 
fund17 

2020 

2021 

2022 

79,417 USD 

80,440 USD 

78,738 USD 

617,131 USD 

0 USD 

0 USD 

________________________ 
17 Commitments in accordance with the agreement concluded with the Secretariat of the Convention in the respective year. 

107