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  COM(2025) 557 final  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     {SWD(2025) 278 final}  
 
 
Abbreviations used 

Agency 

European Chemicals Agency (ECHA) 

BPR 

CLP 

CN 

CUS 

DNA 

Biocidal Products Regulation 

Classification, Labelling and Packaging Regulation 

Combined Nomenclature 

Customs Union and Statistics 

Designated National Authority 

ECHA 

European Chemicals Agency 

ePIC 

EU 

FRA 

IT 

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

European Union 

Final Regulatory Action 

Information technology 

NEA 

National Enforcement Authority 

OECD 

Organisation for Economic Cooperation and Development 

OJ 

PIC 

POP 

Official Journal of the European Union 

Prior Informed Consent 

Persistent Organic Pollutant 

PPPR 

Plant Protection Products Regulation 

REACH  Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation 

RIN 

SDS 

Reference Identification Number 

Safety Data Sheet 

 
 
 
 
1 

INTRODUCTION 

1.1 

The PIC Regulation 

Regulation (EU) No 649/2012 1 (‘the PIC Regulation’) implements the Rotterdam Convention 
on  the  Prior  Informed  Consent  (PIC)  Procedure  for  Certain  Hazardous  Chemicals  and 
Pesticides in International Trade.  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 on 
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. 

The PIC Regulation applies to chemicals listed in Annex III to the Rotterdam Convention and 
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  export  requirements  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, whereas 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 (CLP) Regulation (EC) No 1272/2008 2, and to certain articles. 

The PIC Regulation also places obligations on the Commission to notify the Secretariat of the 
Convention of Final Regulatory Action of chemicals that are banned or severely restricted in one 
use category of the Convention (industrial chemicals or pesticides) and are listed in  Part 2 of 
Annex I to the PIC Regulation. This process is known as 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  corresponds  to  Annex  III  to  the 
Convention), the Commission, on behalf of the EU and based on the empowerment in the PIC 
Regulation,  draws up  an  import  decision  outlining  whether  and  under  which conditions the 
chemical can be imported to the EU. This is sent to the Secretariat of the Convention. 

1.2 

The reporting exercise 

Article 22 of the PIC Regulation requires the Commission to report on its activities under the 
Regulation every three years and to compile a synthesis report that includes the following: 

• 

information  submitted  by  Member  States  under  Article 22(1)  on  the  operation  of  the 
for   customs  controls, 
procedures  provided 
infringements, penalties and remedial action; 

the  Regulation, 

including 

for 

in 

________________________ 
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. 

2 

 
 
 
• 

information  submitted  by  the  Agency  under  Article 22(1)  on  the  operation  of  the 
Regulation’s procedures. 

This third reporting exercise covers the period 2020-2022. The  online  reporting  questionnaire 
was  made  available  to  Member States 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  2020-
2022 report  on  the operation of the procedures of the PIC Regulation 3 in October 2023. 

The  present  report  is  the  summary  of  the  synthesis  report  that  provides  an  overview  of  the 
implementation of the PIC Regulation in the period 2020-2022. 

2 

2.1 

GOVERNANCE OF THE PIC REGULATION 

The Commission, the Agency and DNAs consider that the coordination of their 
activities to implement the PIC Regulation continues to be effective. 

At  national  level,  each  Member  State  designates  a  DNA  to  carry  out  the  administrative 
functions  provided for by the PIC Regulation.  As in  the previous reporting period, Member 
States considered that coordination between DNAs and the Commission, and between DNAs 
and the Agency, had been satisfactory. 

The Commission considered that cooperation with DNAs and the Agency had been satisfactory, 
as concerns both regular exchanges during the reporting period and discussions at the twice-
yearly PIC DNA meetings. 

The Agency reported that they had continued to work well with the DNAs, that coordination 
with the Commission had generally been satisfactory, and that the predictability and planning 
of work had improved. 

2.2 

A  scarcity  of  resources  jeopardises  effective  implementation  and  impedes 
improvement and enforcement activities. 

Resources dedicated to the Commission’s and ECHA’s implementation of the PIC Regulation 
remained at a similar level as in the previous reporting period. 

The  number  of  export  notifications  processed  by  the  Agency  decreased  over  the  period. 
However, the overall processing-related workload of the Agency’s PIC team remained high due 
to an increase in other processing and related tasks, including a notable increase in the number 
of requests for technical / regulatory support. 

Due to the high and growing number of submissions, the Agency continued to invest human 
and financial resources in maintaining and improving the ePIC application, as often requested 
by DNAs, and in the Agency’s processes and ways of working to implement the Regulation. 

PIC DNAs reported resource levels dedicated to implementing the PIC Regulation ranging from 
0.05  to  3.25  FTEs.  The  number  of  Member  States  reporting  that  their  national  enforcement 
authorities have sufficient resources to fulfil their obligations under the Regulation fell to 12, 
from  15  in  the  previous  and  18  in  the  first  reporting  period.  Similarly,  10  Member  States, 
compared to 8 in the previous and 7 in the first reporting period, stated that they do not have 
sufficient resources. 

________________________ 
3 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. 

3 

 
 
 
3 

UPDATING ANNEXES I AND V TO THE PIC REGULATION 

3.1 

Updates to Annex I 

Article 23 requires the Commission to review the list of chemicals in Annex I at least once a 
year on the basis of the developments in EU law – mainly the REACH Regulation 4, the BPR 5 
and  the  PPPR 6  –  and  under  the  Convention.  Annexes  to  the  PIC  Regulation  are  amended 
through delegated acts adopted by the Commission. 

During the reporting period, 48 substances were added to Annex I, 44 of which were included 
in  Parts  1  and  2  of  Annex  I.  Of  these,  35  substances  were  included  because  they  had  been 
banned under the PPPR, 1 due to its non-approval for use in biocidal products under the BPR, 
6  due  to  restriction  under  REACH  (3  for  public  use,  3  for  professional  use),  and  2  due  to 
restriction under the POPs Regulation. 4 substances were added to Part 3 of Annex I following 
their inclusion in Annex III to the Convention. In addition, the EU’s Combined Nomenclature 
codes, listed in Annex I to the PIC Regulation, have been updated. 

Under  Article 11  of  the  Regulation,  the  Commission  must  notify  the  Secretariat  of  the 
Convention in writing of chemicals listed in Part 2 of Annex I that qualify for PIC notification. 
During the reporting period, 31 FRA notifications were submitted to the Secretariat. 

3.2 

Updates to Annex V 

Amendments to Part 1 of Annex V to the PIC Regulation (chemicals subject to an export ban) 
are triggered by the inclusion of a substance in Annex I to the POPs Regulation 7. During the 
reporting period, five substances were added to Part 1 of Annex V. 

Part 2 of Annex V to the PIC Regulation lists chemicals other than POPs subject to an export 
ban. During the reporting period, certain mixtures containing mercury or mercury compounds 
and certain mercury-added products were added to Part 2. 

4 

4.1 

APPLICATION OF THE PIC REGULATION 

Awareness-raising  and  support  to  exporters  and  importers  by  DNAs  and  the 
Agency have continued to improve, boosting compliance. 

24 Member States reported having carried out awareness-raising and information measures, in 
particular  providing  information  online.  Almost all  the  Member  States  that  carried  out  such 
measures considered that this had led to better compliance by exporters and importers. 

The Agency continued to provide information and support to exporters and importers through 
its  website,  weekly  e-News,  newsletter,  social  media,  internal  messaging  in  ePIC  and  the 
helpdesk. It also improved the usability of the ePIC pages 8. 

Other Agency activities included awareness-raising campaigns for exporters, running various 
outreach  events  and  publishing  guidance  on  the  UK’s  withdrawal  from  the  EU  and  on  the 

________________________ 
4 Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 

http://data.europa.eu/eli/reg/2006/1907/oj. 

5 Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, 

http://data.europa.eu/eli/reg/2012/528/oj. 

6 Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, 

http://data.europa.eu/eli/reg/2009/1107/oj. 

7 Regulation (EU) 2019/1021 on persistent organic pollutants, OJ L 169, 25.6.2019, p. 45-77, http://data.europa.eu/eli/reg/2019/1021/oj. 

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

4 

 
 
 
Northern Ireland Protocol to inform companies of their obligations under the PIC Regulation 
after Brexit 9. 

4.2 

The increase in the number of export notifications handled by DNAs and ECHA 
has  levelled  off,  and  the  number  of  notifications  processed  by  Member  States 
continues to vary significantly. 

Export  notifications  are  the  tool  by  which  countries  exchange  information  on  banned  or 
severely restricted chemicals. EU-based exporters intending to export a chemical listed in Part 1 
of Annex I to the Regulation must submit an export notification to their DNA. Once the DNA 
has checked and accepted the notification, it is forwarded to the Agency, which verifies it and 
sends 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  through  ePIC,  and  exporters  must  use  the  notification 
template provided. For certain exports that are exempt from the Regulation or from the export 
notification requirement, exporters must request a special RIN from their DNA and use it in the 
customs declaration to facilitate customs clearance. 

The number of export notifications and special RIN requests increased steadily from 2014 to 
2019 but showed signs of levelling off during the current reporting period (Figure 1). 

Figure 1. Total number of a) export notifications accepted and forwarded to the Agency by DNAs, and 

b) special RIN requests accepted by DNAs per year 

As  in  the  past,  the  number  of  export  notifications  processed  varied  significantly  between 
Member States (Figure 2). 

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

5 

 
 
 
 
 
Figure 2. Total number of export notifications accepted and forwarded to the Agency by DNAs during the 

reporting period  

21 Member States processed more export notifications during this reporting period than in the 
previous one. The number of notifications processed increased the most in Belgium (+ 1 660), 
followed by the Netherlands (+ 901), Germany (+ 768) and Spain (+ 726). 

The  number  of  special  RIN  requests  processed  by  Member  States  varied  widely.  Germany, 
Belgium and France continued to accept the highest number of requests. 

4.3 

The  number  of  export  notification  forms  that  need  to  be  resubmitted  due  to 
incorrect filling has fallen but remains high. 

During  the  reporting  period,  Member  States  requested  the  resubmission  of  3 010  export 
notifications, compared to 5 889 in the previous period and 2 904 in the period before that. The 
main reasons were failure to meet information requirements and issues with the SDS attached 
to the export notification. 

The Agency requested the resubmission of 1 760 export notifications over the reporting period, 
down  from  2 758  in  the  previous  one.  The  trend  is  similar  for  resubmissions  requested  by 
DNAs. 

Member States rejected 738 export notifications during the reporting period, up from 544 in the 
previous  one.  DNAs  report  that  the  main  difficulties  encountered  by  exporters  were  the 
availability of CN or CUS codes and information directly linked to the exports (such as the 
contact details of the importer), where there had been little or no improvement, and the intended 
use of the chemical in the importing country, where there had been significant improvement. 

There had also been considerable improvement in reported difficulties linked to the summary 
of and reasons for the final regulatory action, the date of entry into force and information on 
the final regulatory action taken by the EU. 

6 

 
 
 
 
 
4.4 

The number of export notifications from non-EU countries has increased. 

Article 9 requires the Agency to enter export notifications it receives from non-EU countries in 
its database, acknowledge receipt of the notification to the DNA of the exporting country and 
provide a copy to the DNA of the Member State(s) receiving the import. 

The Agency received 1 863 notifications from non-EU countries in the current reporting period, 
up from 1 371 in the previous period. After a drop in 2020, the number of notifications more 
than doubled by 2022. 

4.5 

Reporting  by  DNAs  on  the  export  and  import  of  chemicals  has  become  more 
effective but could still be improved. 

Article 10 requires exporters and importers of chemicals listed in Annex I to the Regulation to 
inform the DNA of the quantities they exported to or imported from non-EU countries during 
the preceding year. Exporters must also provide the DNA with the names and addresses of each 
importer.  DNAs  must,  in  turn,  provide  this  information  annually  to  the  Agency,  which 
aggregates the data at EU level and makes it publicly available 10. 

Information provided by the Agency and DNAs suggests the reporting process under Article 10 
worked smoothly. 7 Member States reported late submission of information by exporters and 9 
(compared to 5 in the previous reporting period) by importers. There were more mistakes in 
reported quantities, also because the Agency has improved the reporting functionality in ePIC 
by including warnings of potentially erroneous quantities. It has also prepared a checklist for 
DNAs  to  help  them  verify  industry  reports  and  draw  up  aggregated  national  reports  on  the 
quantity of exported and imported chemicals. However, unlike in the previous two reporting 
periods, the Agency noted a delay in the submission of reports from some DNAs. 

4.6 

The EU has adopted import decisions for five substances listed in Annex III to 
the Rotterdam Convention. 

Under Article 10 of the Convention, the Parties are required to adopt an import decision for 
each new chemical listed in Annex III and to submit it to the Secretariat. Under Article 13 of 
the PIC Regulation, EU import decisions are adopted by means of a Commission implementing 
act  submitted  to  the  REACH  Committee  for  an  opinion  in  accordance  with  the  advisory 
procedure. 

During  the  reporting  period  the  Commission  adopted  one  implementing  decision,  which 
provided  new  import  decisions  for  two  substances,  and  amended  decisions  on  three  other 
substances. 

4.7 

Non-EU countries’ response rate to explicit consent requests remains low but is 
rising,  and  improved  systems  and  good  coordination  between  the  Agency  and 
DNAs has had a positive effect. 

Article 14  requires  the  explicit  consent  of  the  importing  country  before  chemicals  listed  in 
Parts 2 or 3 of Annex I can be exported. However, the DNA of the exporter can decide, on a 
case-by-case basis and in consultation with the Commission, to waive this requirement when a 
chemical listed in Part 2 is exported to an OECD country or when the importing country has 
not replied within 60 days, provided that certain conditions are met. 

During  the  current  reporting  period,  19  Member  States  handled  explicit  consent  requests, 
processing  a  total  of  7 233 requests,  up  from  5 058  in  the  previous  period  and  3 362  in  the 

________________________ 
10 ECHA, Annual reporting on PIC experts and imports: https://echa.europa.eu/regulations/prior-informed-consent/annual-reporting-on-pic-

exports-and-imports. 

7 

 
 
 
period before that. The number of requests processed was higher than in the previous period in 
13 Member States (Figure 3). 

Figure 3. Number of requests for explicit consent processed by Member States during the current period 
compared to the previous period for those experiencing the greatest change (% change shown in 
brackets). 

10 Member States reported difficulties in implementing the explicit consent procedure, 3 more 
than  in  the  previous  reporting  period.  Communication  with  the  importing  countries’  DNAs 
continued to be the main challenge. Of the 7 233 requests for explicit consent, 58% received a 
response, slightly more than the 54% of the previous period. 

As in the past, the Agency considered this process to be working smoothly and collaboration to 
be  effective.  According  to  feedback  from  DNAs,  determining  the  validity  period  and  some 
specific restrictions (i.e. RIN specificity, exporter specificity) are the most difficult issues faced 
when interpreting responses. 

11 Member States, compared to 8 in the previous period and 6 in the period before that, had to 
decide whether explicit consent was required for exporting chemicals listed in Part 2 of Annex 
I to OECD countries. No Member States reported difficulties in taking this decision. 

15 Member States, up from 13 in the previous period and 11 in the period before that, received 
waiver requests under Article 14(7). The number of waiver requests increased from 571 in the 
previous period to 1 328 in the current period. Only 1 Member State reported difficulties in 
implementing the waiver procedure. 

The Commission considered the waiver procedure to work smoothly in general and assessed 
collaboration with the DNAs as positive. The Agency also considered the process to be working 
smoothly overall and certain inefficiencies reported in previous periods to have been addressed. 

10 Member States reported cases where exports were allowed to go ahead pending the reply to 
a request for explicit consent under Article 14(8). The total number of cases was 181 compared 
with  569  in  the  previous  reporting  period.  The  Agency  reported  no  difficulties,  a  marked 
improvement  from  the  previous  period.  This  was  mainly  due  to  improvements  in  the  ePIC 
functionality. 

8 

 
 
 
 
 
4.8 

There were fewer instances of non-compliance with information requirements for 
exported chemicals. 

Article 17 states that exported chemicals must be packaged and labelled in accordance with the 
relevant EU provisions, unless the importing country requires otherwise.  An SDS compliant 
with  Annex  II  to  the  REACH  Regulation  must  be  sent  to  each  importer  together  with  the 
exported chemical. 

Only  3  Member  States  reported  compliance  issues,  compared  to  6  in  the  previous  period, 
concerning the information that must accompany exported chemicals. 

4.9 

All  Member  States  have  control  and  enforcement  systems,  but  fewer  Member 
States report having an enforcement strategy. 

All Member States have designated authorities with responsibility for enforcing the Regulation 
with respect to controlling the import and export of chemicals listed in Annex I in accordance 
with Article 18. In all Member States except one this involves customs, and in most Member 
States the environmental/health inspectorate is also involved. 

12 Member States have an enforcement strategy, down from 16 in the previous period. In some 
Member States this was because enforcement was already in place and no further development 
was needed. 12 Member States provide regular training for inspectors and some include the PIC 
Regulation as an occasional topic in general training on chemicals legislation. Overall, regular 
training has declined and for the first time, a few Member States indicated that no training was 
carried out due to lack of resources or financial constraints. 

17 Member States reported having carried out controls on exports and 12 on imports during the 
period. As in the past, few infringements were detected. DNA feedback on the Forum activities 
was mostly positive. 

The number of Member States indicating that enforcement authorities have sufficient resources 
to fulfil their obligations under the Regulation fell from 15 in the previous period to 12 in the 
current period. 10 Member States, compared to 8 in the previous period, stated they did not 
have sufficient financial and/or human resources. 

4.10  While  enforcement  activities  have  increased  in  some  Member  States,  fewer 

infringements lead to penalties. 

The types of enforcement activity carried out were largely the same as in the previous period 
(Figure 4). However, documentary checks were  performed by 4 more Member States (80%) 
and  proactive/routine  inspections  by  3 more  Member  States.  More  than  half  conducted 
investigations  or  reactive  or  proactive  inspections,  and  just  under  half  reported  carrying  out 
inspections or on-site checks. 

9 

 
 
 
Figure 4. Enforcement activities carried out in the Member States 

During  the  reporting  period,  a  total  of  93 691  controls  were  performed  on  exports,  up  from 
9 132 in the previous period and 6 474 in the period before that. This significant increase is 
mostly due to desktop inspections conducted by Bulgaria (40 425) and unspecified controls by 
Spain (42 168) (Table 1). With respect to imports, 60 421 controls were carried out, up from 
1 463 in the previous period and 1 941 in the period before that. This large increase is mostly 
due to controls by Spain (58 177). Customs controls continue to account  for the majority of 
controls. 

Table 1. Total number of official controls on exports and imports involving checks under the PIC Regulation during 

the reporting period (previous period in brackets) 

Official controls on exports 

Controls performed by 
customs 
93 308 (8 599) 

Controls performed by 
inspectors 
383 (526) 

Controls performed by 
other entities 
0 (7) 

Official controls on imports 

59 299 (237) 

1 082 (1 193) 

40 (33) 

7 Member States, compared to 5 in the previous and 3 in the first reporting period, reported that 
they had identified infringements through customs controls, but the ratio of infringements was 
very low (around 0.3%) 11. 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. 
The ratio of infringements is higher than for customs controls (around 5.4% 12). 

The  main  category  of  infringement  found  by  customs  related  to  Box  44  of  the  single 
administrative document not being properly filled in (60 infringements) and absence of a RIN 
(46 infringements). The main category of infringements found by inspectors concerned Safety 
Data Sheet provisions (35 infringements) and absence of an export notification for the chemical 
(20 infringements). 

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

________________________ 
11 Due to possible overlaps between controls performed on exports and on imports, this is only an indicative figure for comparison. 

10 

 
 
 
 
 
 
 
4.11 

Technical assistance by the Agency continued to be welcomed. 

The  Agency  was  involved  in  cooperation  activities,  including  three  regional  workshops  to 
improve the capacity of parties to the Rotterdam Convention, two webinars and a workshop 
organised by the Convention to support different regions. The Agency also provided support to 
candidate  countries,  aimed  at  increasing  their  chemical  management  capacity,  via  the  EU 
Instrument  for  Pre-accession  Assistance.  No  Member  States  participated  in  cooperation 
activities during this reporting period. 

4.12 

ePIC  users  generally  found  the  IT  tool  more  user-friendly  and  useful  to  their 
work. 

The  Agency  developed  and  maintains  ePIC,  the  IT  tool  used  by  all  relevant  authorities, 
including  enforcement  authorities  and  customs,  as  well  as  by  exporters  and  importers.  The 
number of ePIC users from industry has doubled since the previous period, accounting for 91% 
of users. 

New features added to ePIC during the period led to reduced processing times, more efficient 
processes  and  improved  case  traceability  and  consistency  and  reliability  of  data.  DNAs 
generally  rated  ePIC  as  user-friendly  and  helpful  in  carrying  out  their  main  tasks  and  saw 
improvement since the previous period (Figure 5). 

Figure 5. Is the ePIC system easy to use for DNAs? 

Both  DNAs and  the  Agency  reported  mainly  positive feedback  on ePIC  from  industry. The 
usability study launched by the Agency at the end of 2022 had produced a number of proposals 
for improvement, some of which had been prioritised for implementation, with more planned 
for a later stage. 

4.13 

Information and data on the implementation of the PIC Regulation has become 
more accessible. 

An  improved  PIC  dissemination  platform  went  live  in  November  2022  to  ensure  efficient 
dissemination  of  PIC  data  and  better  integration  with  the  Agency’s  cross-regulation 

11 

 
 
 
 
dissemination  platform.  In  December  2022  information  was  added  on  EU  import  responses 
under the Rotterdam Convention 12. 

The Agency has published three reports on trade for 2019, 2020 and 2021 under Article 10, two 
reports on the exchange of information covering 2018-2019 and 2020-2021 under Article 20 13, 
and a report on the operation of the Regulation covering 2020-2022 pursuant to Article 22 14. 

5 

CONCLUSIONS 

The PIC Regulation transposes the Rotterdam Convention in EU law. It has the same objectives 
but  goes  beyond  the  provisions  of  the  Convention  to  offer  a  higher  level  of  protection,  in 
particular to developing countries and countries with economies in transition. 

This  report  shows  that  the  procedures  laid  down  by  the  PIC  Regulation  and  their 
implementation work smoothly, in particular thanks to effective coordination and cooperation 
between DNAs, ECHA and the Commission on both internal EU tasks and international work. 
This has been fundamental to achieving the objectives of the Regulation. 

The  export  notification  procedure  ensures  the  importing  countries  receive  important 
information on the chemicals and their exports. There are more than 10 000 export notifications 
per  year,  which  clearly  shows  the  scale  of  this  information  exchange.  This  creates  a  high 
workload for the Agency and DNAs that can only be handled with appropriate staff resources. 
The performance of the IT application ‘ePIC’, developed and maintained by the Agency, plays 
an important role in this regard. 

The use of the explicit consent procedure as a standard procedure for exporting a number of 
chemicals, which goes beyond the Convention, meant that 7 233 requests for explicit consent 
were sent to importing countries in the reporting period. This high number of requests created 
difficulties for many importing countries, with 42% of requests remaining unanswered. 

Exporters of chemicals subject to the PIC Regulation were generally aware of their obligations 
and able to meet them. The DNAs and the Agency provided the necessary assistance, helping 
to  keep  the  number  of  infringements  low.  Although  customs  authorities  carried  out  a  high 
number of controls  on exports  (93 308) and imports (59 299),  the  rate of infringements  was 
very low at around 0.3%. The rate was somewhat higher, at around 5.4%, for controls performed 
by inspectors. 

In  general,  while  the  Member  States  were  able  to  meet  their  obligations  they  sometimes 
struggled to cope with the high number of export notifications at the end of each year and to 
meet  deadlines.  The  Agency’s  work  was  fully  in  line  with  the  requirements  of  the  PIC 
Regulation and essential to the smooth functioning of the procedures. The Commission fulfilled 
its  obligations  under  the  PIC  Regulation,  adopting  two  delegated  regulations  that  added 
48 chemicals to Annex I and one implementing  decision on EU import decisions during the 
reporting  period.  In  addition,  the  Commission  coordinated  the  EU’s  contribution  to 
international work and represented the EU at the Convention. 

________________________ 
12 https://echa.europa.eu/eu-import-responses-under-the-rotterdam-convention. 

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

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

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