REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Summary of the Synthesis Report on the operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals
Date: 2022-09-13
Institutions: Directorate-General for Environment, European Commission
Subjects: European Chemicals Agency, application of EU law, chemical product, dangerous substance, environmental protection, exchange of information, export (EU), import (EU), information technology applications, public health

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 13.9.2022  COM(2022) 412 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  {SWD(2022) 218 final}  
 
 
ABBREVIATIONS USED 

BPR 
CLP 
DNA 
ECHA  
ePIC 
EU 
FRA 
NEA 
OECD  
PIC  
PPPR   
REACH 

RIN 
SDS 

Biocidal Products Regulation  
Classification, Labelling and Packaging Regulation  
Designated National Authority  
European Chemicals Agency  
Software application for implementation of Regulation (EU) No 649/2012 
European Union 
Final Regulatory Action 
National Enforcement Authority  
Organisation for Economic Cooperation and Development 
Prior Informed Consent  
Plant Protection Products Regulation  
Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
Regulation  
Reference Identification Number  
Safety Data Sheet  

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1.  INTRODUCTION  

1.1.  The PIC Regulation  

Regulation (EU) No 649/20121 (‘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, by providing for a decision-making process within the 
Union on their import and export and by disseminating decisions to Parties 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 Union 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 (CLP) Regulation (EC) No 1272/20082, and to certain articles.  

The PIC Regulation also places obligations on the Commission to notify the Secretariat of the 
Convention  of  Final  Regulatory  Action  (FRA)  on  chemicals  that  are  banned  or  severely 
restricted in the Union in one use category of the Convention (industrial chemicals or pesticides) 
and which are listed in Part 2 of Annex I of the PIC Regulation. This process is known as the 
FRA notification and is the basis for the listing of chemicals in Annex III to the Convention. 

For chemicals that are listed in Part 3 of Annex I (which reflects Annex III to the Convention), 
the Commission, on behalf of the Union and based on the empowerment in the PIC Regulation, 
establishes an import decision that outlines whether and under which conditions the chemical 
can be imported in the Union. This is sent to the Secretariat of the Convention. 

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

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

2  Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  of  the  Council  of  16  December  2008  on  classification, 
labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and 
amending Regulation (EC) No 1907/2006, OJ L 353, 31.12.2008, pp. 1–1355.  

2 

 
 
 
                                                 
1.2.  The reporting exercise  

Article 22 of the PIC Regulation requires the Commission to report on its activities under the 
Regulation every three years, and to compile a synthesis report on the performance of the PIC 
Regulation, integrating:  

  The  information  submitted  by  Member  States  as  per  Article  22(1),  concerning  the 
operation of the procedures provided for in this Regulation, including customs controls, 
infringements, penalties and remedial action. 

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

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

This reporting exercise is the second under  the PIC Regulation and covers the period 2017-
2019. The online reporting questionnaire was made available to the Member States on 9 June 
2021, with a deadline for completion set to 27 August 2021. All reports were submitted by mid-
November 2021. The Agency published its report on the operation of the PIC Regulation3 for 
the period 2017-2019 in August 2020. The present report is the summary of the synthesis report, 
which provides an overview of the implementation of the PIC Regulation in the period 2017-
2019.  

2.  GOVERNANCE OF THE PIC REGULATION 

2.1.  The  Commission,  the  Agency  and  DNAs  consider  that  the  coordination  of 
their activities in the implementation of the PIC Regulation is effective  

At national level, each Member State designates a national authority (DNA) to carry out the 
administrative functions foreseen by the PIC Regulation. As in the previous reporting period, 
Member States considered the coordination between DNAs and the Commission, and between 
DNAs  and  the  Agency  is  satisfactory.  Several  DNAs  valued  the  support  provided  by  the 
Commission and the Agency for its swiftness and quality. The Agency rates collaboration with 
DNAs as similarly  effective, including  when handling disagreements.  The Commission also 
considered the cooperation with DNAs to be effective, in particular through discussions at the 
twice-yearly PIC DNA meetings.  

The Agency considered the collaboration with the Commission satisfactory, pointing however 
to a number of areas for improvement.  The Commission also considered the cooperation with 
the Agency to be satisfactory, highlighting the regular exchanges on scientific, technical and 
legal questions arising in the context of implementation and their practical implementation. 

2.2.  The continuous increase in PIC activities creates challenges for maintaining 

an appropriate level of resources 

Resources dedicated to implementation of the PIC Regulation by the European Commission 
and  ECHA  remained  quite  stable  compared  to  the  previous  reporting  period,  although  both 
institutions reported a slight increase. The Agency’s workload during the reporting period was 
in line with the predicted workload. The number of export notifications processed has continued 
to increase in line with the predicted 10% yearly increase.  

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

3 

 
 
                                                 
The increase in export notifications has led to an increase in processing tasks to be performed 
by the Agency and in stakeholder support. Support provided by the Agency to the Commission, 
EU-  and  non-EU  DNAs  has  taken  approximately  30-40%  of  staff  time  during  the  reporting 
period. As the amount of resources  is not  increasing proportionally to  the workload, ECHA 
stresses  in  its  report  the  necessity  to  secure  sufficient  human  and  financial  resources  to 
implement the PIC Regulation and to further improve implementation practices, processes and 
tools.  

PIC DNAs reported levels of resources dedicated to the implementation of the PIC Regulation 
ranging from 0.1 to 2 FTEs. To the extent that comparison is possible, resources have remained 
quite stable in many DNAs, with around eight reporting a decrease. In parallel, the workload 
linked to export notification processing has increased in many Member States (see section 4.2). 
Less  Member  States  than  in  the  previous  reporting  period  stated  that  they  have  sufficient 
resources for enforcement (15 instead of 18).  

3.  UPDATES OF ANNEX I TO THE PIC REGULATION  

According to Article 23, the list of chemicals in Annex I should be reviewed at least once a year 
by  the  Commission,  on  the  basis  of  the  developments  in  EU  law  –  mainly  in  the  REACH 
Regulation4,  the  BPR5  and  the  PPPR6  –  and  under  the  Convention.  Annexes  to  the  PIC 
Regulation are amended through delegated acts adopted by the Commission. 

During the reporting period, 31 substances were included in Part 1 and seven in Part 2 of Annex 
I. Twenty-three of these substances were included due to the non-approval as plant protection 
products under the PPPR, and five after inclusion in Annex XVII to REACH (Table 1). Six 
were included in Part 3 of Annex I following their inclusion in Annex III to the Convention. 
With the exception of short chain chlorinated paraffins, these had already been included in Parts 
1 and 2 of Annex I to the PIC Regulation. 

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

Delegated Act 

Chemical  

CAS number 

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

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

10519-33-2 
81-15-2 

85-68-7 
10605-21-7 
28159-98-0 

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

Basis for 
inclusion  
PPPR 
REACH 

Parts 1 and 2 
Part 1 
Parts 1 and 2 

REACH 
PPPR 
BPR 

4 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, 
Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 
as  well  as  Council  Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC, OJ L 396, 30.12.2006, pp. 1–854.  

5 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available 

on the market and use of biocidal products, OJ L 167, 27.6.2012, pp. 1–123.  

6 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of 
plant  protection  products  on  the  market  and  repealing  Council  Directives  79/117/EEC  and  91/414/EEC,  OJ  L  309, 
24.11.2009, pp. 1–50.  

4 

 
 
 
                                                 
Delegated Act 

Chemical  

CAS number 

(EU) No 649/2012 

Diisobutyl phthalate 
Diarsenic pentaoxide 
Tepraloxydim 
Triclosan 
Triflumuron 
Tris 
phosphate 
Methamidophos 

(2-chloroethyl) 

84-69-5 
1303-28-2 
149979-41-9 
3380-34-5 
64628-44-0 
115-96-8 

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

Basis for 
inclusion  
REACH 
REACH 
PPPR 
BPR 
BPR 
REACH 

10265-92-6 

Parts 1 and 3 

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

Amitrole 
Beta-cypermethrin 
Carbofuran 

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

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

459 

KE 

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

chlorinated 

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

Parts 1 and 2 

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

Triasulfuron 
Trichlorfon 

82097-50-5 
52-68-6 

Parts 1 and 2 
Parts 1 and 3 

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

2-naphthyloxyacetic acid  
Acetochlor 
Asulam 

Chloropicrin 
Diphenylamine 
Flufenoxuron 
Naled 
Propanil 
Propargite 
Alachlor 

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

Part 2  
Parts 1 and 2 
Parts 1 and 2 

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

Aldicarb 

116-06-3 

Part 3 

Endosulfan 

115-29-7 

Part 3 

III 

III 

III 

III 

III 

III 

III 

Annex 
Rotterdam 
Convention 
PPPR 
PPPR 
Annex 
Rotterdam 
Convention  
PPPR 

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

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

As per Article 11 of the PIC Regulation,  the  Commission  must  notify the Secretariat  of the 
Convention,  in  writing,  of  the  chemicals  listed  in  Part  2  of  Annex  I,  which  qualify  for  PIC 
notification.  Ten  FRA  notifications  were  submitted  to  the  Secretariat  during  the  reporting 
period:  

5 

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

4.  OPERATION OF THE PIC REGULATION  

4.1.  Awareness-raising activities and support provided by DNAs and the Agency 

to exporters have improved compliance 

Twenty-seven Member States carried out awareness-raising and information activities targeting 
exporters and importers. The most common activity was the provision of online information 
(specific webpage or references to the Agency’s webpages on PIC). Eleven Member States also 
provide helpdesk services via an existing helpdesk (e.g. REACH, CLP, BPR) and six operate a 
PIC  national  helpdesk;  ten  Member  States  indicated  having  a  specific  email  address  for 
information  requirements.  Almost  all  Member  States  stated  that  these  activities  improved 
compliance  among  exporters  and  importers  with  the  PIC  Regulation.  Some  DNAs  noted  an 
increase in the number of export notifications and improvements in their quality, an increase in 
the number of companies registered in ePIC or using it, and improved compliance with Article 
10 reporting obligations.  

The Agency is required to provide assistance, as well as technical and scientific guidance and 
tools to exporters and importers (Article 6(1)). The Agency provided information and support 
to exporters and importers through its website, weekly e-News, the ECHA Newsletter, social 
media,  internal  messaging  in  e-PIC,  and  the  ECHA  Helpdesk.  The  Agency  published  four 
guidelines  (“In  brief”  documents)  to  assist  companies  with  special  RIN  (Reference 
Identification Number) requests, waivers, reporting and filling section 6 of export notifications 
(prohibited and allowed uses). The Agency also prepared for post-Brexit export notifications 
by publishing a guideline on “How to notify PIC exports to the UK after the UK’s withdrawal 
from  the  EU”  and  establishing  a  manual  notification  procedure  (until  those  can  be  made  in 
ePIC).  

4.2.  The  number  of  export  notifications  handled  by  DNAs  and  ECHA  has 
continuously increased since 2014 and their processing is unevenly distributed 
between Member States  

The export notification is the instrument by which countries exchange information on banned 
or severely restricted chemicals. All EU based exporters must submit an export notification to 
their DNAs if they intend to export chemicals listed in Part 1 of Annex I to the PIC Regulation. 
Once the DNA has checked and accepted the notification, it is forwarded to the Agency, which 
also checks the compliance of the notification and transmits it to the DNA of the importing 

6 

 
 
 
country. If no acknowledgement of receipt is received, the Agency sends the notification again. 
The  whole  procedure  is  carried  out  through  ePIC,  and  exporters  must  use  the  notification 
template provided by the system. For certain exports that are exempt from the PIC Regulation 
or from  the export notification requirement, exporters are required to  request  a Special RIN 
from their DNA and to use it in the customs declaration to facilitate customs clearance. 

The number of export notifications and Special RIN requests have continuously increased since 
2014 (Figure 1). The Agency reported an increase in the number of export notifications from 
8 455 in 2017 to 10 009 in 20197. According to the Agency, this increase reflects increased 
compliance and the addition of new substances to Annex I.  

Figure 1 :  Total number of export notifications accepted and forwarded to the Agency by DNAs 

and of Special RIN requests accepted by DNAs per year since 20148 

12000

10000

8000

6000

4000

2000

0

1553

1470

2014

8352

8522

9884

10083

5866

2641

2961

3259

3922

4146

2015

2016

2017

2018

2019

Export notifications (total EU)

Special RIN Request (total EU)

As in the previous reporting period, the number of export notifications and special RIN requests 
processed  varied  significantly  between  Member  States  (Figure  2).  The  highest  numbers  of 
export notifications  were in  Germany (8 645 notifications) and France (6  855), followed by 
Italy (2 453), Spain (2 383) and the UK (2 207). Twenty Member States processed more export 
notifications during this reporting period compared to the previous one and in nine Member 
States,  this  number  more  than  doubled  between  the  two  reporting  periods.  The  situation  is 
similar for special RIN requests, where 11 Member States did not receive any, whilst Germany, 
Belgium  and  France  were  the  Member  States  that  accepted  the  highest  number  of  them. 
Thirteen  Member  States  processed  more  Special  RIN  requests  during  this  reporting  period 
compared  to  the  previous  one.  Four  Member  States  did  not  process  any  export  notification 
(Cyprus, Greece, Luxembourg and Malta). 

7 Figures provided for the Agency includes initial submissions, re-submissions and rejections. 

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

7 

 
 
 
 
 
 
 
 
 
                                                 
Figure 2 :  Total  number  of  export  notifications  and  Special  RIN  requests  accepted  by  DNAs 

during the reporting period  

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100000

10000

1000

100

10

1

DE; 13541

FR; 8026

BE; 3916

AT; 1383

IT; 2554

NL; 1068

PL; 1079

ES; 3006

UK; 3092

SE; 433

BG; 227

HR; 207

DK; 202

CZ; 143

FI; 103

HU; 365

IE; 67

LV; 28

LT; 17

PT; 141

SI; 196

SK; 14

RO; 7

EE; 1

Member States

4.3. 

Incorrect filling of the export notification form still leads to a high number of 
requests for resubmission 

Member States and ECHA requested the resubmission by the exporter of 5 889 and 2 758 export 
notifications respectively during the reporting period. Main issues were the unclear or incorrect 
filling of section 6.2 of the export notification on prohibited and allowed uses, and of section 
3.3 on intended uses. Another reason for requesting resubmission was the provision of incorrect 
or insufficient contact details for the importer. The provision of the SDS in an inappropriate 
language is also mentioned as an issue by DNAs and ECHA.  

4.4.  Reporting under Article 10 generally worked effectively, although the quality 

of DNAs’ reporting could still be improved 

Article 10 places obligations on exporters and importers to inform the DNA, during the first 
quarter  of  each  year,  of  the  quantity  of  chemicals  listed  in  Annex  I  of  the  PIC  Regulation 
exported to, or imported from, third 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 to the Agency annually, which then aggregates the data at EU level and makes 
it publicly available on its database9. 

Information  provided  by  the  Agency  and  DNAs  suggested  that  the  reporting  process  under 
Article 10 worked effectively. Less Member States than in the previous reporting period (seven) 
stated that they experienced delays from exporters in submitting information on the quantity of 
the  chemicals  exported,  and  these  delays  did  not  affect  the  completion  of  DNA’s  reporting 
exercise. According to ECHA, reporting from DNAs has improved as less DNAs reported data 
that are out of scope. However, some of the data submitted by DNAs contained errors derived 

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

reporting-on-pic-exports-and-imports  

8 

 
 
 
 
 
 
                                                 
 
 
 
 
 
 
 
 
from industry reporting and required correction, re-aggregation and resubmission of the reports 
by the DNAs. This has led to inefficiencies in the preparation of the overall report and ECHA 
therefore recommends that DNAs increase verification of aggregated data before submission.  

4.5.  EU import decisions have been adopted for  four substances listed in Annex 

III to the Rotterdam Convention  

As per Article 10 of the Convention, Parties are requested to adopt an import decision for each 
new chemical listed in Annex III and to submit it to the Secretariat. Pursuant to Article 13 of 
the PIC Regulation, the Union import decision is adopted by means of an implementing act of 
the Commission, which is drafted by the Commission services and submitted to the REACH 
Committee for an opinion,  in  accordance with  the advisory  procedure. During the reporting 
period,  the  Commission  adopted  one  Implementing  Decision  in  2018,  which  provided  new 
import decisions for four substances and amended one import decision (Table 2).  

Table 2: Union import decisions adopted during the reporting period  

Implementing 
Act 
Commission 
Implementing 
Decision  of  10 
October 2018 

Chemicals 

Nature / status of decision  

Carbofuran 

1563-66-2 

Trichlorfon 

52-68-6 

Short-chain 
chlorinated 
paraffins 
Tributyltin 
compounds  

85535-84-8 

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

New 
decision 
New 
decision 
New 
decision 

New 
decision 

Ethylene Oxide   75-21-8 

Modification  Final  

Import 
decision 
Final  

Grounds for decision 

No consent to import 

Final  

No consent to import 

Final  

Final  

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

Consent to import only 
subject 
specified 
to 
conditions 

4.6.  The  low  response  rate  of  non-EU  countries  to  explicit  consent  requests 
remains  a  problem  but  many  issues  are  effectively  solved  through  good 
coordination between ECHA and DNAs  

Article 14 requires the consent of the importing country before an export of chemicals listed in 
parts 2 or 3 of Annex I can proceed. However, the DNA of the exporter can decide, on a case-
by-case basis and in consultation with the Commission, to waive the requirement for explicit 
consent  when  a  chemical  qualifying  for  PIC  notification  is  exported  to  an  OECD  country 
(Article 14(6)) or when no reply from the importing country has been received after 60 days 
and provided that certain conditions are met (Article 14(7)).  

Nineteen Member States processed exports where the explicit consent procedure pursuant to 
Article 14 was involved. A total of 5 058 requests for explicit consent were processed by DNAs 
between 2017 and 2019, compared with 3 362 in the previous reporting period. In 15 Member 
States (out of 19), the number of requests was higher than in the previous reporting period.  

9 

 
 
 
 
 
 
As  previously,  the  main  challenge  reported  by  DNAs  was  late  responses  from  importing 
countries to consent requests (i.e. after the 60-day waiting period) or no response at all. The 
response rate remained rather low during this reporting period. Of the 5 058 requests for explicit 
consent,  54%  received  responses  following  either  the  initial  request,  the  first  or  the  second 
reminder, which is  a roughly similar response rate  as  in  the past. DNAs also  stated that the 
response provided was not always clear or was difficult to interpret and that certain countries 
were particularly difficult to reach. 

The Agency considered that this process is working smoothly and that collaboration with DNAs 
is effective. Despite a low response rate, the process has contributed, according to the Agency, 
to harmonised data and the reduction of clerical errors during the procedure. 

Few Member States had to decide whether or not the requirement for explicit consent should 
be waived (eight for an export to an OECD country and 13 in the absence of a response from 
the  competent  authority  of  the  importing  country),  and  information  provided  by  DNAs 
suggested  that  few  implementation  problems  occurred.  Fifteen  Member  States  experienced 
cases where the export was allowed to proceed pending a reply to a new request for explicit 
consent  (Article  14(8)).  According  to  the  Agency,  Article  14(8)  remained  challenging  to 
implement. However, the number of problematic cases (i.e. in which the Agency and the DNAs 
disagree on the interpretation) has been substantially reduced after it was discussed in a DNA 
meeting and the related ePIC functionality was enhanced accordingly. 

4.7. 

Few  Member  States  reported  non-compliance  with  requirements  on 
information to accompany exported chemicals 

Article 17 states that exported chemicals must be packaged and labelled in accordance with the 
respective Union provisions, unless the importing country requires otherwise. An Safety Data 
Sheet  compliant  with  Annex  II  of  the  REACH  Regulation  must  be  sent  to  each  importer 
together with the chemical. Only six Member States reported compliance issues concerning the 
information  accompanying  exported chemicals,  related to  packaging  requirements under the 
CLP Regulation and the SDS. 

4.8.  All Member States have control and enforcement systems but a third of them 

do not have an enforcement strategy 

According to Article 18 of the PIC Regulation, Member States must designate authorities, such 
as  customs  authorities,  to  control  imports  and  exports  of  chemicals  listed  in  Annex  I.  All 
Member States have nominated these authorities. Customs are involved in the implementation 
of the PIC Regulation in all Member States, except Malta  (and the United Kingdom for the 
reporting period before 1st January 2020). In six countries, the customs administration is the 
only NEA.  

Fifteen Member States (compared to 18 in the previous reporting period) indicated that NEAs 
have sufficient resources to carry out their obligations under the PIC Regulation. Member States 
that highlighted resource issues within National Enforcement Authorities typically referred to 
the  lack  of  human  resources.  Seventeen  Member  States  reported  having  a  strategy  for  the 
enforcement of the PIC Regulation and 16 Member States have established regular training for 
inspectors. 

10 

 
 
4.9. 

Few infringements have been identified during the reporting period 

The number of Member States that reported official control activities is quite comparable to the 
previous reporting period, and still rather low considering that 24 Member States reported trade 
activities. Unless Member States specified it in their report, it cannot be concluded whether this 
results from a lack of data collection or a lack of enforcement activities. Ten Member States 
reported customs controls on exports in which the PIC Regulation was covered, compared to 
13  in  the  previous  reporting  period.  Eleven  Member  States  reported  controls  carried  out  by 
inspectors. Regarding imports, four Member States reported customs controls and ten reported 
controls carried out by inspectors.  

A total of 9 132 controls of exports were performed during the reporting period, compared to 
6 474 controls in the period 2014-2016 (Table 3). On imports, 1463 controls have been carried 
out, compared to 1941 in 2014-2016, mostly due a decrease in customs controls on imports. As 
in  the  past,  customs  controls  represent  the  majority  of  controls.  The  number  of  controls 
performed varied greatly between Member States, which could be due to the number of exports 
and imports of PIC chemicals in the country, the inspection strategy, or the types of controls 
performed (e.g. reactive controls versus regular monitoring). 

Regarding the types of enforcement activities carried out, documentary checks are carried out 
in  around  two  thirds  of  the  Member  States  (19),  while  less  than  half  reported  carrying  out 
proactive inspections or on-site checks (Figure 3).  

Table 3 : Total number of official controls on exports and imports in which the PIC Regulation 

was covered or enforced during the reporting period 

Official controls on 
exports 
Official controls on 
imports 

Controls performed by 
customs 
8599 

Controls performed by 
inspectors  
526 

Controls performed by 
other entities 
7 

237 

1193 

33 

Figure 3: Enforcement activities carried out in Member States  

Documentary checks

19

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

Proactive/routine inspections

On-site checks

14

13

12

Announced inspections

11

Unannounced inspections

Sampling

Others

8

7

7

0

2

4

6

8

10

12

14

16

18

20

Number of Member States

11 

 
 
 
 
 
 
 
The number of infringements found (138) is rather low compared to the number of controls 
carried out. Five Member States reported infringements identified through customs controls and 
six  through controls  carried out  by inspectors. The main  category of infringement found by 
customs  related  to  the  absence  of  the  RIN  (13  infringements)  and  Box  44  of  the  single 
administrative document not being properly filled (12 infringements). Penalties were imposed 
in three Member States in 29 cases of infringements.  

4.10.  The  first  pilot  project  on  the  enforcement  of  the  PIC  Regulation  was 

implemented by the Forum during the reporting period  

The Forum for Exchange of Information on Enforcement (Forum) is a network of authorities 
responsible for the enforcement of the REACH, CLP, PIC and POP  regulations. During 2017-
2018, the Forum conducted a pilot project on the control of compliance with the PIC Regulation 
focusing on export notifications (Articles 8, 14, and 15) and information to accompany exported 
chemicals (Article 17), to which thirteen Member states participated. Member States completed 
296  inspections,  consisting  of  both  on-site  and  desktop  inspections10.  In  2019,  the  Forum 
prepared  a ‘Practical enforcement  guide for the control of PIC obligations’ describing  good 
practices in the enforcement of Articles 8, 14, 15 and 17 of the PIC Regulation, as developed 
during the pilot project. 

Member States are generally satisfied with the activities carried out by the Forum. A number 
of  DNAs  underlined  the  benefits  of  the  pilot  project  and  suggested  that  other  pilot  projects 
should be implemented in the future.  

4.11.  Several  DNAs  and  the  Agency  have  participated  in  technical  assistance 

activities  

According to 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 develop the infrastructure, capacity and expertise 
needed to manage chemicals properly throughout their lifecycles. 

Five Member States participated in cooperation activities and four in projects or international 
activities related to capacity-building in chemicals management. DNA activities consisted of 
the  provision  of  technical  information  through  workshops,  training,  visits  of  experts’ 
delegations from third countries, etc., cooperation projects and support for the establishment or 
maintenance  of  DNAs.  ECHA  participated  in  several  training  events  organised  by  the 
Rotterdam Convention, the Commission or DNAs. The Agency also provided support to pre- 
and candidate countries to increase their capacity in the area of chemical management via the 
EU Instrument for Pre-accession assistance (IPA). 

4.12.  ePIC users generally found the IT tool user-friendly and adequate to support 

their work  

As requested by the PIC Regulation, the Agency developed and maintains the IT tool (ePIC) to 
support the implementation. A number of new features were added to the ePIC system during 

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

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the reporting period in order to improve the functioning and usefulness of the tool. The tool is 
used  by  all  relevant  authorities,  including  enforcement  authorities  and  customs,  and  by 
exporters and importers. The number of users from industry, DNAs and NEAs has increased 
since the previous reporting period.  

Overall, DNAs found ePIC to be user-friendly and did not experience major issues  using it. 
DNAs’ opinion on ePIC has improved since the previous reporting period and more DNAs have 
experience with it. Feedback from industry users to the Agency and DNAs was also generally 
positive, as was the feedback from customs and enforcement authorities.  

4.13.  Information  and  data  on  the  implementation  of  the  PIC  Regulation  are 

publicly available  

According  to  the  PIC  Regulation,  the  Agency  should  make  the  following  data  publicly 
available:  

  The list of chemicals included in Annex I (Article 7); 
  The updated list of chemicals subject to export notification, and the importing Parties 

and other countries for each calendar year (Article 8); 

  Reports on actual quantities of chemicals subject to the PIC Regulation exported and 

imported (Article 10); 
Import decisions (Article 13); 

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

This information is available on the Agency’s webpage dedicated to the PIC Regulation and 
the webpage dedicated to chemicals subject to PIC, which provides a searchable database of 
chemicals subject to PIC, non-confidential data on EU export notifications, export notifications 
and explicit consents received from non-EU countries, and DNAs’ contact details. Reports on 
actual quantities of PIC chemicals exported and imported (pursuant to Article 10) are provided 
on the page ‘Annual reporting on PIC exports and imports’. During the reporting period, the 
Agency published the first Report on the operation of the PIC Regulation (pursuant to Article 
22) in 2017 and the second Report on information exchange (pursuant to Article 20) in 2018. 

5.  CONCLUSIONS 

The  PIC  Regulation  implements  the  Rotterdam  Convention  in  the  Union  and  has  the  same 
objectives. However, the PIC Regulation goes beyond the requirements of the Convention in 
order to offer a higher level of protection, in particular to developing countries and countries 
with economies in transition. 

This report demonstrates that the procedures established by the PIC Regulation operated well 
and  that  their  implementation  worked  well,  in  particular  due  to  effective  coordination  and 
cooperation between DNAs, ECHA and the Commission, both for EU internal and international 
work, which was the basis for achieving its objectives. 

The export notification procedure provided the importing countries with important information 
on many chemicals and their export. With 10 000 export notifications in 2019 and its continuing 
upward  trend,  the  scale  of  the  information  exchange  and  its  potential  to  increase  further  is 
clearly visible. The increasing workload can only be handled with appropriate staff resources, 

13 

 
 
 
given  the  need  to  maintain  the  capacity  for  processing  and  support  while  ensuring  the 
performance of the IT application ‘ePIC’, developed and maintained by the Agency. 

The application of explicit consent procedure as a standard procedure for the export of certain 
chemicals, which goes beyond the Convention, has led to the high number of 5 058 requests for 
explicit consent sent to importing countries in the reporting period. Those requests presented a 
challenge for many importing countries,  which is shown by the share of 46% that remained 
unanswered. 

The  exporters  of  chemicals  subject  to  the  PIC  Regulation  were  generally  aware  of  their 
obligations and able to meet them. If needed, the DNAs and the Agency provided the necessary 
assistance, which has contributed to the low number of infringements.  During this reporting 
period,  9  132  controls  on  exports  and  1  463  controls  on  imports  were  reported  and  138 
infringements were detected, out of which 29 led to penalties. 

In general, the Member States met their obligations, although the high workload at the end of 
each year - caused by the large number of export notifications – presented a challenge for some 
Member States and sometimes led to problems with timeframes. The contribution of the Agency 
to implementation was fully in line with the requirements of the PIC Regulation and the basis 
for effective functioning of the procedures. The Commission completed its obligations under 
the PIC Regulation. Three Commission Delegated Regulations amending Annex I, as well as 
one Commission Implementing Decision adopting Union import decisions, were adopted in the 
reporting period. In addition, the Commission coordinated the contribution of the Union to the 
international work and represented the Union at the Convention. 

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