COMMISSION STAFF WORKING DOCUMENT Synthesis Report on the Operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals Accompanying the document Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Summary of the Synthesis Report on the operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals
Date: 2018-10-17
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, 17.10.2018 SWD(2018) 438 final  COMMISSION STAFF WORKING DOCUMENT Synthesis Report on the Operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals Accompanying the document Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Summary of the Synthesis Report on the operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals {COM(2018) 697 final}  
 
 
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  EN 

 
 
 
Contents 

1 

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

The PIC Regulation ....................................................................................... 5 
1.1 
1.2 
The reporting exercise .................................................................................. 6 
1.3  Methodology ................................................................................................ 6 
Preparation of the Commission’s report .............................................. 6 
Implementation  of  the  common  format  for  reporting  for  Member 
States in the form of a web-based questionnaire ................................. 7 
Synthesis of Member States’ reporting ............................................... 8 
Drafting the synthesis report and summary ........................................ 8 

1.3.3 
1.3.4 

1.3.1 
1.3.2 

2 

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

2.1  Organisation of the implementation of the PIC Regulation ................................. 9 
European Commission ...................................................................... 9 
European Chemicals Agency (ECHA) .................................................. 9 
DNAs ............................................................................................ 11 

2.1.1 
2.1.2 
2.1.3 

2.2  Coordination  between  the  Commission,  the  Agency  and  Designated  National 

Authorities .................................................................................................. 14 
Coordination between DNAs and the Commission ............................... 14 
2.2.1 
Coordination between DNAs and the Agency ...................................... 14 
2.2.2 
2.2.3 
Coordination between the Agency and the Commission ....................... 14 
The EU as a Party to the Rotterdam Convention .............................................. 15 
Coordination of Union input to the Conference of the Parties (CoP) ....... 16 
2.3.1 
Participation in committees and expert groups ................................... 16 
2.3.2 
Financial contributions to the Rotterdam Convention ........................... 17 
2.3.3 

2.3 

3 

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

3.1  Update of Annex I ....................................................................................... 18 
3.2  Updates of Annex V ..................................................................................... 20 

4 

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

4.1 

4.2 

Support to exporters and importers ............................................................... 21 
Support provided by DNAs ............................................................... 21 
4.1.1 
Support provided by the Agency ....................................................... 22 
4.1.2 
Export notifications forwarded to Parties and other countries (Article 8) ............. 24 
Export notifications processed during the reporting period ................... 25 
4.2.1 
Special RIN requests processed during the reporting period ................. 26 
4.2.2 
Requests for resubmission and rejection of export notifications ............ 27 
4.2.3 
Difficulties encountered in the export notification procedure ................ 29 
4.2.4 
Emergency situations (Article 8(5)) .................................................. 31 
4.2.5 
Provision of available additional information on exported chemicals ...... 32 
4.2.6 
4.2.7 
Administrative fee for export notifications .......................................... 32 
Export notifications from Parties and other countries (Article 9) ........................ 32 
Information on export and import of chemicals (Article 10)............................... 33 

4.3 
4.4 
4.5  Notification  of  banned  or  severely  restricted  chemicals  under  the  Convention 

(Article 11-12) ............................................................................................ 33 
4.6  Obligations in relation to importing chemicals (Article 13) ................................ 34 
4.7  Obligations  in  relation  to  exports  of  chemicals,  other  than  export  notifications 

(Article 14) ................................................................................................. 35 
4.7.1 

Communication  of  information  and  decisions  to  those  concerned 
within the jurisdiction of a Member State (Article 14(3)) ..................... 35 
Explicit consent (Article 14(6)) ......................................................... 35 

4.7.2 

1 

 
 
4.7.3  Waivers (Article 14(6) and (7)) ........................................................ 37 
4.7.4 
Validity of explicit consent (Article 14(8)) .......................................... 38 
Information on transit movement (Article 16) ................................................. 39 

4.8 
4.9  Requirements  linked  to  exported  chemicals  and  accompanying  information 

(Article 17) ................................................................................................. 39 
4.10  Enforcement of Regulation (EU) No 649/2012 (Article 18) ................................ 40 
4.10.1  National enforcement authorities (NEAs) ........................................... 40 
4.10.2  Training inspectors ......................................................................... 41 
4.10.3  Enforcement strategy ...................................................................... 41 
4.10.4  Enforcement activities ..................................................................... 42 
4.10.5  Enforcement actions and penalty systems ......................................... 44 
Infringements during the reporting period ......................................... 44 
4.10.6 
4.10.7  Collaboration between DNAs and NEAs .............................................. 46 
4.10.8  Forum activities ............................................................................. 47 
4.11  Exchange of information (Article 20) .............................................................. 48 
4.12  Technical assistance (Article 21).................................................................... 49 
4.13  IT-related aspects ....................................................................................... 50 
4.13.1  The ePIC system ............................................................................ 51 
4.13.2  User-friendliness of the ePIC system ................................................. 52 
4.13.3  Areas of improvement ..................................................................... 54 
4.13.4  Data dissemination ......................................................................... 54 

2 

 
 
 
 
Abbreviations used  

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

RIN 
SAICM  
SDS 

Biocidal Products Regulation  
Classification, Labelling and Packaging Regulation  
Combined Nomenclature 
Conference of the Parties to the Rotterdam Convention  
Chemical Review Committee of the Rotterdam Convention  
Customs Union and Statistics  
Designated National Authority  
Designated National Authority  
European Chemicals Agency  
Software application for implementation of Regulation (EU) No 649/2012 
European Union 
Final Regulatory Action 
National Enforcement Authority  
Organisation for Economic Cooperation and Development 
Prior Informed Consent  
Persistent Organic Pollutants  
Plant Protection Products Regulation  
Rotterdam Convention 
Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
Regulation  
Reference Identification Number  
Strategic Approach to International Chemicals Management  
Safety Data Sheet  

3 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1  INTRODUCTION  

1.1  The PIC Regulation  

Regulation  (EU)  No  649/20121  (‘the  PIC  Regulation’)  implements  the  Rotterdam 
Convention  on  the  Prior  Informed  Consent  (PIC)  Procedure  for  Certain  Hazardous 
Chemicals and Pesticides in International Trade, adopted in 1998 and ratified by the EU 
in  2002.  The  Regulation  aims  to  promote  shared  responsibility  and  cooperation  in  the 
international  movement  of  hazardous  chemicals,  and  to  protect  human  health  and  the 
environment from potential harm by facilitating the exchange of information concerning 
the  characteristics  of  hazardous  chemicals,  providing  for  a  decision-making  process 
within the EU on the import and export of  such chemicals, and disseminating decisions 
to Parties to the Convention and other countries (Article 1).  

The  PIC  Regulation  applies  to  chemicals  subject  to  the  PIC  procedure  under  the 
Rotterdam  Convention,  as  well  as  to  industrial  chemicals  (used  by  professionals  and 
consumers) and pesticides (including biocides) that are banned or severely restricted by 
EU legislation for health or environmental reasons. The Regulation places obligations on 
companies  intending  to  export  such  chemicals  to  third  countries,  whether  or  not  they 
are  Parties  to  the  Rotterdam  Convention.  Exports  are  subject  to  different  requirements 
depending  on  their  listing  in  Annex  I  to  the  Regulation:  chemicals  listed  in  Part  1  of 
Annex  I  are  subject  to  export  notification  to  the  authority  of  the  importing  country; 
chemicals listed in Parts 2 and 3 of Annex I are subject to export notification and explicit 
consent  of  the  authority  of  the  importing  country,  unless  they  are  subject  to  the  PIC 
procedure  under  the  Convention  and  exported  to  a  Party  that  has  provided  a  positive 
import  response,  or  to  a  country  that  has  waived  its  right  to  be  notified.  These 
obligations  also  apply  to  mixtures  containing  substances  listed  in  Annex  I  to  the 
Regulation  in  concentrations  that  trigger  labelling  obligations  under  the  Classification, 
Labelling  and  Packaging  Regulation  (EC)  No  1272/20082  (CLP  Regulation),  and  to 
articles  containing  substances  listed  in  Parts  2  or  3  of  Annex  I  in  unreacted  form,  or 
mixtures  containing  substances  listed  in  Parts  2  or  3  of  Annex  I  in  concentrations  that 
trigger labelling obligations under the CLP Regulation.  

The PIC Regulation also places obligations on the Commission to notify the Secretariat of 
the  Convention  of  Final  Regulatory  Action  (FRA)  on  chemicals  that  are  banned  or 
severely  restricted  through  FRA  in  the  EU  in  one  use  category  of  the  Convention 
(industrial chemicals or pesticides) and which are listed in Part 2 of Annex I  of the PIC 
Regulation, as well as to inform other Parties about their potential risks and allow them 
to  consider  whether  or  not  risk  management  measures  are  needed  in  their  own 
territories. This process is known as the FRA notification and is the basis for the listing of 
chemicals in Annex III to the Convention.  

For  chemicals  that  are  listed  in  Part  3  of  Annex  I  (which  reflects  Annex  III  to  the 
Convention),  the  Commission,  in  close  cooperation  with  the  Member  States,  decides  if 
the  chemical  can  be  imported  in  the  EU  and  under  which  conditions.  This  is  done 
through an import decision, which is then sent to the Secretariat of the Convention. 

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

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

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

4 

 
 
 
 
 
                                                 
1.2  The reporting exercise  

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

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

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

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

This  reporting  exercise  is  the  first  under  the  new  PIC  Regulation.  It  covers  the  three 
years  of  implementation  since  the  Regulation  became  applicable  (20143-2016).  A 
common reporting format for Designated National Authorities (DNAs) was established by 
Commission Implementing Decision (EU) 2016/770 of 14 April 20164, in order to collect 
consistent  information  across  Member  States.  Similarly,  a  reporting  format  for  the 
Agency’s  report  was  adopted  through  Commission  Implementing  Decision  (EU) 
2016/1115 of 7 July 20165. 

Although  the  Member  States  and  the  Agency  were  required  to  report  by  31  May  2017, 
the  reporting  process  encountered  some  delays.  The  report  from  the  Agency  was 
received  on  18  July  2017,  while  the  Member  States’  reporting  was  completed  on  5 
October 2017, when the final reporting questionnaire was submitted.  

The  present  report  is  the  synthesis  report  (as  per  Article  22  of  the  PIC  Regulation), 
bringing  together  the  findings  from  the  reports  of  the  Commission,  the  Agency’s,  and 
Member States. It provides an overview of the implementation of the PIC Regulation in 
the period 2014-2016.  

1.3  Methodology 

1.3.1  Preparation of the Commission’s report 

The report is divided into two sections, the first addressing the work of the Commission 
with  respect  to  implementation  within  the  EU,  and  the  second  addressing  the 
international work of the Commission as the EU DNA to the Rotterdam Convention. 

Additional  relevant  information  was  compiled  from  EUR-lex,  the  website  of  the 
Rotterdam  Convention,  and  documents  published  on  CIRCABC,  including  minutes  of 
meetings,  and  other  documents  discussed  at  DNA  meetings  (see  Table  1).  Other 
information  was  obtained  first-hand  from  Commission  officials.  Sources  used  for  this 
report  are  listed  in  Table  1  below.  The  report  was  then  used  as  a  source  for  the 
synthesis report. 

3 Regulation (EU) No 649/2012 applied from 1 March 2014.  
4 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.  

5 Commission Implementing Decision (EU) 2016/1115 of 7 July 2016 establishing a format for the submission 
by the European Chemicals Agency of information concerning the operation of the procedures pursuant to 
Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and 
import of hazardous chemicals, C/2016/4141, OJ L 186, 9.7.2016, pp. 13–23.  

5 

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

List of relevant documents consulted  

Implementing and delegated acts  

  Commission Delegated Regulation (EU) No 1078/2014 amending Annex I to the PIC Regulation.  
  Commission Delegated Regulation (EU) 2015/2229 amending Annex I to the PIC Regulation.  
  Commission  Implementing  Decision  of  11  February  2016  adopting  Union  import  decisions 

(2016/C 61/06).  

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

152/02). 

  Commission  Implementing  Decision  of  14  April  2016  establishing  a  common  format  for  the 
submission of information concerning the operation of the procedures pursuant to Regulation 
(EU) No 649/2012 of the European Parliament and  of the Council concerning the export and 
import of hazardous chemicals. 

  Commission Implementing  Decision  of  7  July  2016  establishing  a  format  for  the  submission  by 
the European Chemicals  Agency of information concerning the operation of the procedures 
pursuant  to  Regulation  (EU)  No  649/2012  of  the  European  Parliament  and  of  the  Council 
concerning the export and import of hazardous chemicals. 

DNA meeting documents  

  Minutes of 23rd, 24th, 25th, 26th, 27th and 28th DNA meetings.  
  Amendments to  Annex I to Regulation (EU) No 649/2012 presented at 23rd, 24th, 25th, 26th, 27th 

 
 

and 28th DNA meetings. 
Import decisions presented at 23rd, 24th, and 26th DNA meetings. 
Submission of notifications to the PIC secretariat presented at 23rd, 24th, 25th, 26th, 27th and 28th 
DNA meetings. 
Implementation issues presented at 23rd, 24th, 25th, 26th, 27th and 28th DNA meetings. 

 
  Documents on the preparation of COP 7 and 8 presented at 25th, 26th and 28th DNA meetings. 

Rotterdam Convention documents  

 

PIC circulars published by the Rotterdam Convention.  

1.3.2  Implementation  of  the  common  format  for  reporting  for 
Member States in the form of a web-based questionnaire 

The  common  reporting  format  was  made  available  online  to  Member  States  on  2 
February  2017,  through  EU  Survey.  A  guidance  document  for  Member  States 
accompanied  the  invitation  email.  The  project  team  was  also  available  to  answer  DNA 
questions on EU Survey and/or the reporting format, as well as supporting the DNAs in 
submitting their questionnaires.  

To facilitate Member State reporting, the Agency has made data from ePIC available to 
DNAs for the following questions:  

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

accepted by DNA and forwarded to the Agency.  

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

either to request resubmission or because the notification was rejected.  

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

responses received per year. 

  Section 7 - Question 43: number of cases where DNA had to decide if no explicit 
consent  was  required  in  case  of  chemicals  listed  in  Part  2  of  Annex  I  to  be 
exported to OECD countries. 

  Section 7 - Question 45: number of waiver requests received by DNAs.  
  Section  7  -  Question  47:  number  of  cases  where  the  export  was  allowed  to 

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

6 

 
 
 
 
 
 
For  consistency,  the  data  provided  by  the  Agency  were  used  for  these  questions,  even 
where  the  data  provided  by  the  Member  States  differed  from  that  data  sent  by  the 
Agency. 

1.3.3  Synthesis of Member States’ reporting  

Once all Member States had returned their reporting questionnaires, the full dataset and 
statistics were downloaded in excel format from EU Survey. The information provided by 
the  DNAs  was  compiled  and  summarised  for  each  question  and  presented  visually, 
where relevant. The full set of DNA responses is available in Annex II.  

1.3.4  Drafting the synthesis report and summary  

The synthesis report combines the information from the Commission report, the Member 
States’ reporting questionnaires and the Agency’s questionnaire. It follows the structure 
of  the  common  Member  States’  reporting  questionnaire  and  the  questionnaire  for  the 
Agency’s  reporting,  integrating  the  information  from  the  Commission  report,  where 
relevant.  The  summary  follows  the  same  structure  as  that  of  the  synthesis  report, 
presenting the key facts and conclusions from each section. 

7 

 
 
 
 
 
2  GOVERNANCE OF THE PIC REGULATION  

2.1  Organisation of the implementation of the PIC Regulation  

2.1.1  European Commission  

The Commission, in cooperation with the Member States,  is responsible for policy work 
under the PIC Regulation, in particular the adoption of amendments to Annexes I and V 
to the Regulation. In addition, the Commission is responsible for the legal interpretation 
of the Regulation, and representation of the Union in the Convention and towards non-
EU  Parties,  which  includes  acting  as  a  common  designated  authority  for  the 
administrative  functions  of  the  Convention  with  respect  to  the  PIC  procedure  (see 
Section  2.3).  The  Commission  also  chairs  the  DNA  meetings  that  occur  twice  a  year, 
normally in April and October.  

DG  Environment  takes  charge  of  the  PIC  Regulation.  Unit  B.2  –  sustainable  chemicals 
has  one  policy  coordinator  responsible  for  implementation  of  the  PIC  Regulation, 
including policy and legal matters and international cooperation and representation. The 
policy coordinator is supported by a lawyer for legal questions, and by a secretary for all 
organisational  work.  For  international  work,  Unit  B.2  has  one  expert  (the  policy 
coordinator)  who  was  nominated  to  the  Convention  bodies,  i.e.  the  Chemical  Review 
Committee  (CRC)  and  the  intersessional  working  group  on  the  process  of  listing 
chemicals  in  Annex  III  to  the  Convention.  In  addition,  colleagues  of  Unit  F.3,  which  is 
responsible  for  multilateral  environmental  cooperation,  contribute  to  the  international 
work, particularly in the context of the CoP, by dealing with horizontal and cross-cutting 
matters  such  as  financial  resources,  budget,  technical  assistance  and  some  legal 
matters.  The  staff  resources  occupied  by  this  work  amount  to  0.4  FTE  for  the  policy 
coordinator and 0.4 FTE for the supporting work, including international matters. 

2.1.2  European Chemicals Agency (Agency) 

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

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

  Sending  a  second  export  notification  if  the  Agency  does  not  receive  an 
acknowledgement  of  receipt  from  the  authority  in  the  non-EU  country  within 30 
days of the first notice (Article 8(3)). 

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

DNAs (Article 9(1)). 

  Acknowledging  receipt  of  export  notifications  received  from  non-EU  countries 

(Article 9(1)). 

  Sending  a  reminder  for  an  explicit  consent  request  if  no  response  is  received 
from the authorities in the non-EU  country within 30 days of the initial request; 
sending  a  second  reminder  after  a  further  30  days  if  a  response  is  still 
outstanding (Article 14(6)). 

  Managing ePIC and keeping all relevant document available on the platform; 
  Supporting  the  EU  DNAs  and  the  European  Commission  in  assessing  waivers 

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

  Aggregating  and  summarising  the  data  received  each  year  from  DNAs  on  the 
quantities  of  exported  and  imported  chemicals,  and  making  non-confidential 
information publicly available (Article 10(3)). 

8 

 
 
 
  Every  two  years,  compiling  and  publishing  the  information  transmitted  by  the 
Commission,  the  Member  States  and  the  Agency  to  the  authorities  in  third 
countries on the chemicals subject to the Regulation.  

  The  Agency’s  Secretariat  of  the  Forum  for  Exchange  of  Information  on 
Enforcement established by the REACH Regulation also provides coordination and 
support to discussions related to PIC (Article 18(2)). 

  Participate  in  the  twice-yearly  DNA  meetings  organised  by  the  Commission  and 
provide updates on the operations and opinions of relevant documents discussed 
at these meetings. 

In  addition,  the  Agency  provides  assistance  and  technical  and  scientific  guidance  to 
industry,  the  DNAs  from  Member  States  and  third  countries,  and  the  European 
Commission (Article 6). 

Resources  dedicated  by  the  Agency  to  the  operation  of  the  PIC  Regulation  have 
remained stable over the reporting period (see Table 2).  

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

2014 
2015 
2016  

Number of staff working on PIC (FTE) 
7 
7 
7 

The  Agency’s  staff  working  on  PIC  also  collaborate  with  the  staff  working  on  other  EU 
regulations  for  which  the  Agency  is  responsible,  i.e.  REACH,  CLP  and  the  Biocidal 
Products Regulation (BPR), where there are synergies with processes that run across the 
various pieces of legislation. For example, the Agency’s staff collaborate on: 

  Development  and  maintenance  of  ePIC  in  order  to  benefit  from  synergies 
between all the Agency’s IT tools concerning login and account management;  

  Support to (Article 8(2) stakeholders; 
  Substance identity check of substances added to the PIC Regulation; 
  Publication of data on the Agency’s website;  
  Safety  Data  Sheet  (SDS)  checks  (e.g.  inaccuracies  in defining  the  concentration 

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

  Support  to  the  Commission  in  drafting  FRA  notifications  submitted  to  the 

Rotterdam Convention Secretariat; 

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

on the CRC; 

  Drafting guidance for the implementation of the PIC Regulation; 
  Legal advice; 
  Communications;  
  Human resources. 

The Agency’s workload during the reporting period was higher than predicted before the 
entry  into  force  of  the  Regulation.  As  highlighted  in  its  report,  the  number  of  export 
notifications  increased  beyond  the  predicted  10%  yearly  increase  (see  Table  3),  which 
led to an increase in processing tasks to be performed by the Agency and thus the time 
spent on supporting DNAs (from EU and non-EU countries), which takes 30-40% of staff 
time.  The  increase  in  export  notifications  also  made  additional  improvements  of  ePIC 
necessary  (e.g.  increasing  the  automation  of  certain  processes  to  reduce  the  workload 
for industry users and authorities and enable them to meet legal deadlines), and caused 
more requests for support from the Agency (see Table 4). 

9 

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

No. of estimated notifications 
Actual no. of notifications  

2014 
4,000 
4,575 

2015 
4,300 
5,460 

2016 
6,300 
7,967 

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

No.  of  requests 
regulatory support 

for 

technical/ 

2014 
1,000 

2015 
1,500 

2016 
1,800 

As the distribution of work is uneven during the calendar year, peaking during the winter 
months, the Agency reported regularly hiring interim staff for several months every year 
to meet the increased need.   

2.1.3  DNAs  

Member States play a major role in the application, implementation, and enforcement of 
the  PIC  Regulation.  As  per  Article  4  of  the  PIC  Regulation,  Member  States  must 
designate one or several authorities to carry out the administrative functions required by 
the Regulation. A total of 35 authorities have been designated by Member States. Article 
18  of  the  PIC  Regulation  also  requires  Member  States  to  designate  enforcement 
authorities, such as customs authorities (see Section 4.10).  

The  responsibilities  of  the  Member  States  are  largely  discharged  by  DNAs  and  can  be 
divided in four categories: administrative tasks, enforcement, monitoring and reporting, 
and exchange of information6.  

Administrative tasks 

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

Agency (Article 8(2)). 

  Request  explicit  consent  from  the  DNA/appropriate  authority  of  the  importing 
country for the export of the chemicals listed in Parts 2 and 3 of Annex I. In the 
case  of  export  of  Annex  I  Part  2  chemicals  to  OECD  countries,  decide  (in 
consultation with the Commission) if the requirement for explicit consent may be 
waived  on  the  basis  of  the  chemical  being  licensed,  registered  or  authorised  in 
the OECD country concerned (Article 14(6)).  

  Consult  the  Commission  and  take  decisions  on  the  granting  of  a  waiver  for  the 
export of chemicals listed in Parts 2 and 3 of Annex I in cases where no response 
is received within 60 days of a request for explicit consent (Article 14(7)).  

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

(Article 14(8)).  

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

(2)). 

  Provide  the  Commission  with  sufficient  information  on  FRA  to  ban  or  severely 
restrict  a  chemical  at  national  level  and  consider  any  comments  received  from 
other Member States (Article 11(8)). 
Inform the Commission of national regulatory actions related to PIC chemicals so 
that  this  information  can  be  taken  into  account  in  EU  import  decisions  (Article 
13(2))  and  make  EU  import  decisions  available  to  those  concerned  within  their 
competence (Article 13(5)). 

 

6 Adapted from: ECHA, Guidance for implementation of Regulation (EU) No 649/2012 concerning the export 

and import of hazardous chemicals, version 1.1, 2015.  

10 

 
 
 
 
 
 
 
 
 
 
                                                 
  Forward information on chemicals subject to the PIC procedure and on decisions 
of importing parties regarding import conditions applicable to those chemicals to 
those  concerned  within  its  jurisdiction  (Article  14(3)  in  conjunction  with  Article 
14(1)). 

  Handle Special RIN requests. 
  Participate  in  twice-yearly  DNA  meetings  organised  by  the  Commission,  and 

provide opinions on relevant documents discussed at these meetings. 

Enforcement 

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

Articles 8, 10, 14, 15 and 17. 

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

infringements (Article 28). 

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

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

Monitoring and reporting  

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

Annex I (Article 10(3)). 

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

the PIC Regulation (Article 22). 

Provision and exchange of information 

  Provide  importing  countries  with  additional  information  relating  to  exported 

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

  Assist  the  Commission  in  compiling  additional  information  with  respect  to  FRA 

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

  Where  requested,  advise  and  assist  importing  countries  to  obtain  additional 
information  to  help  them  with  an  import  response  for  PIC  chemicals  (Article 
14(5)). 

  Forward to the Commission (with a copy to the Agency) any information required 
by an importing Party to the Convention that has been provided by the exporter 
concerned prior to each transit movement of a chemical listed in Part 3 of Annex 
I (Article 16(3)). 

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

promotion of technical assistance (Article 21). 

Most  Member  States  (22)  have  only  one  DNA,  while  six  have  two  or  three  (Table  5). 
DNAs  are  mostly  Ministries  or  agencies  responsible  for  environment,  chemicals,  and 
health  or  health  and  safety.  In  a  few  cases,  the  Ministries  responsible  for  economy, 
competition, labour or agriculture have been designated as competent authorities. In the 
Netherlands, the customs authority is the only DNA.  

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

Member States  
Greece  

Hungary  

Ireland 

Distribution of responsibilities  
Directorate  of  Energy,  Industrial  and  Chemical  Products,  General 
Chemical State Laboratory: responsible for industrial chemicals 
Department  of  Plant  Protection  Products  and  Biocides,  Ministry  of 
Rural Development and Food: responsible for pesticides 
Ministry of Human Capacities: responsible for industrial chemicals  
National Food Chain Safety Office: responsible for pesticides 
The Health and Safety Authority: DNA for industrial chemicals 
The  Revenue  Commissioners:  solely  for  the purposes  of  Article  18 
of the PIC Regulation  
The  Minister  for  Agriculture,  Food  and  the  Marine:  responsible  for 
pesticides  (other  than  for  the  purposes  of  Article  18  of  the 
Rotterdam Regulation)  

11 

 
 
 
 
 
 
 
Member States  
Latvia 

Slovakia 

UK 

Distribution of responsibilities  
Latvian Environment, Geology and Meteorology Centre: responsible 
for industrial chemicals 
State Plant Protection Service: responsible for pesticides  
Ministry of Economy: responsible for industrial chemicals 
Ministry  of  Agriculture  and  Rural  Development:  responsible  for 
pesticides 
Health and Safety Executive: DNA for Great Britain 
Health  and  Safety  Executive  Northern  Ireland:  DNA  for  Northern 
Ireland  

Although  the  UK  officially  has  two  DNAs,  through  an  agreement  between  Great  Britain 
and  Northern  Ireland,  all  of  the  UK  DNA  work  is  carried  out  by  the  Health  and  Safety 
Executive. 

In  Member  States  with more  than  one  DNA,  responsibilities  are  generally  divided,  with 
one DNA responsible for industrial chemicals while another is responsible for pesticides. 
Table 5 provides information on the distribution of responsibilities among those Member 
States with several DNAs.  

With the exception of the Netherlands, DNAs in all other Member States are involved in 
the  implementation  of  other  EU  or  international  chemicals  management  instruments, 
such  as  legislation,  conventions  or  programmes  (see  Figure  1).  Twenty  DNAs  (in  19 
Member  States)  are  also  responsible  for  the  implementation  of  the  REACH  Regulation, 
21  DNAs  (in  20  Member  States)  for  CLP,  15  for  the  BPR  and  8  for  the  PPPR.  In  eight 
Member  States,  the  DNAs  are  also  involved  in  the  implementation  of  the  Stockholm 
Convention.  

The  resources needed to implement the PIC Regulation in Member States, in particular 
the human resources, largely depend on the number of export notifications and requests 
for  explicit  consent  that  are  processed.  The  figures  provided  by  Member  States  for 
human  resources  working  on  PIC  in the  DNAs  vary  between  0.1  FTE  for  those  Member 
States with few or no export notifications to process, and 2 FTE for those Member States 
with the highest numbers of export notifications. 

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

CLP

REACH

BPR

PPPR

Detergents Regulation

POPs Regulation

Ozone depleting substances Regulation

0

5

10

15

20

25

Number of DNAs 

12 

 
 
 
 
 
 
 
 
 
 
2.2  Coordination between the Commission, the Agency and Designated 

National Authorities 

2.2.1  Coordination between DNAs and the Commission  

All  Member  States  considered  the  coordination  between  the  DNAs  and  the  Commission 
to  be  satisfactory.  Three  Member  States  mentioned  that  the  regular  DNA  meetings  are 
an important coordination mechanism, and seven indicated that the support provided by 
the  Commission  to  DNAs  (especially  answers  to  DNA  questions)  is  quick  and  of  good 
quality.  

According to the DNAs, the update of annexes (Article 23) and the obligation to monitor 
exporters’  compliance  (Article  18(1))  are  areas  that  could  still  be  improved.  Several 
DNAs  also  mentioned  that  relevant  documents  should  be  made  available  in  due  time 
before DNA meetings.  
For  its  part,  the  Commission  also  considered  the  cooperation  with  DNAs  to  be 
satisfactory.  There  have  been  regular  exchanges  during  the  reporting  period  on 
scientific,  technical  and  legal  questions  arising  in  the  context  of  implementation,  in 
particular  through  discussions  at  the  twice-yearly  PIC  DNA  meetings.  The  Commission 
also  coordinates  and  consults  with  DNAs  on  any  submissions  to  the  Secretariat  of  the 
Rotterdam Convention.  

2.2.2  Coordination between DNAs and the Agency  

All Member States considered the coordination between the DNAs and the Agency to be 
satisfactory.  Eight Member States  specified that the assistance provided by the Agency 
to DNAs is valued for its swiftness and quality.  

The  main  areas  of  improvement,  according  to  the  DNAs,  are  the  updating  of  annexes 
(Article 23), followed by technical assistance (Article 21), and the provision of additional 
information on exported chemicals, on request (Article 8(7)).  

According  to  the  Agency,  the  collaboration  with  DNAs  is  also  satisfactory.  It  indicated 
that  collaboration  with  DNAs  is  efficient  and  friendly,  including  when  handling 
disagreements. Cooperation could be improved, however, regarding the implementation 
of Article 8(2) on the timelines for processing export notifications, Article 8(5) on export 
in case of an emergency situation, Article 14(6) on substances that cannot be exported 
unless  certain  conditions  are  fulfilled,  and  Article  14(6)  and  (7)  on  decisions  that  the 
export can proceed in the absence of an explicit consent.  

2.2.3  Coordination between the Agency and the Commission  

The  Commission  considered  cooperation  with  the  Agency  to  be  satisfactory,  as  there 
were regular exchanges on scientific, technical and legal questions arising in the context 
of  implementation,  in  particular  on  the  legal  interpretation  of  provisions  and  their 
practical implementation. The Agency participated in all DNA meetings to report on the 
work  done  in  the  area  of  implementation.  The  Commission  contributed  to  the 
development  of  the  guidance  produced  by  the  Agency,  as  well  as  to  the  work  of  the 
Forum on Exchange of Information on Enforcement. 

Regarding  the  cooperation  with  third  countries  and  the  Secretariat  of  the  Rotterdam 
Convention, the Commission and the Agency have closely coordinated their activities to 
ensure that the most appropriate and effective assistance is provided and that resources 
are used efficiently.   

According  to  the  Agency,  coordination  with  the  Commission is  generally  satisfactory.  It 
did, however, point to the following areas which could be improved:  

13 

 
 
 
 
 
 
 
  Preparation  of  FRA  notifications 

the  Rotterdam  Convention 
Secretariat: In some cases, tasks have been assigned with a short deadline and 
without  advance  warning.  Increased  predictability  and  common  planning  would 
help the Agency to ensure timely development of good quality notifications. 

to 

  Technical  preparation  of  meetings:  the  Agency  mentioned  that  documents 
are often sent by the Commission for checking/drafting with very short deadlines, 
making it difficult for the Agency to produce high-quality documents. Preparation 
for the meetings could be improved by greater collaboration between the Agency 
and the Commission/ Member State experts.  

  Article  14(6)  and  (7)  on  decisions  that  the  export  can  proceed  in  the 
absence  of  an  explicit  consent:  The  Agency  mentioned  that  there  is  a 
relatively  high  number  of  cases  in  which  they  need  to  ask  the  Commission  to 
verify and subsequently amend/reject the decision (when relevant) due to clerical 
errors  (e.g.  incorrect  validity  dates,  missing  translations  of  documents, 
questionable  supporting  documentation).  This  slows  down  the  process  and,  in 
many  cases,  triggers  requests  for  clarification  from  exporters.  An  enhanced  role 
for the Agency in this process could improve its efficiency and effectiveness. 

  Article 23 on updating annexes: The Agency believes it would be beneficial for 
it  to  be  involved  at  an  early  stage  in  the  adoption  of  amendments  to  the 
Regulation.  For  example,  it  suggested  checking  the  substance  identity  of 
chemicals proposed for amendments to ensure consistency with processes under 
the other legislations it manages. It also proposed that, based on Article 6(1)(f), 
the Commission could consider asking for its support in identifying and proposing 
further  candidate  substances  for  inclusion  in  the  PIC  Regulation.  Finally,  the 
Agency  would  like  to  contribute  to  the  planning  of  the  entry  into  application  of 
amendments  to  the  Regulation,  in  order  to  avoid  co-occurrence  with  the  annual 
export notification peak in the winter.  

  Day-to-day  exchanges  between  the  Agency  and  the  Commission: 
According to the Agency, there is room for improvement in the timing of replies, 
as delays create problems for the performance of its operational tasks.  

2.3  The EU as a Party to the Rotterdam Convention  

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

  Representation of the EU to the Rotterdam Convention.  
  Coordination  of  EU  input  on  all  technical  issues  related  to  the  Convention,  the 

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

  Submission to the Secretariat of relevant FRA notifications concerning chemicals 

qualifying for PIC notification.  

  Transmission  of  information  on  other  FRA  involving  chemicals  not  qualifying  for 

PIC notification.  

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

PIC procedure. 

  Exchange of information with the Secretariat in general.  

The  Member  States,  as  Parties  to  the  Convention,  also  participate  in  the  CoP,  the  CRC 
and  activities  under  the  Convention,  such  as  the  intersessional  working  group  on  the 
process of listing chemicals in Annex III to the Convention. The Member States and their 
DNAs provide input to the EU position on matters discussed at the CoP. Some DNAs also 
participate in technical assistance activities under the Convention, to  which the Agency 
also contributes.  

14 

 
 
 
 
 
2.3.1  Coordination  of  Union  input  to  the  Conference  of  the  Parties 

(CoP) 

The 7th Conference of the Parties to the Rotterdam Convention took place from 4 to 15 
May  2015  (thus  during  the  reporting  period),  back-to-back  with  the  12th  CoP  to  the 
Basel Convention and the 7th CoP to the Stockholm Convention.  

Before  CoP  7,  the  Commission  prepared  the  draft  position  of  the  EU  on  matters 
discussed at the meeting:   

  A proposal for a Council Decision establishing the EU position on amendments to 
Annex III to the Convention, seeking a mandate for decision-making at the CoP. 
This document was then discussed by the Council Working Party on International 
Environmental  Issues  and  by  the  Council  Working  Party  on  Environment,  and 
adopted by the Council on 6 March 2015.  

  A position paper, discussed with the Member States at the Council Working Party 
on  International  Environmental  Issues’  meetings,  outlining  the  position  to  be 
taken on the various items that would be discussed at the CoP. The final version 
of this position paper was adopted in April 2015. 

  A  position  paper  on  budget  and  management  issues  covering  the  Rotterdam, 
Basel  and  Stockholm  Conventions,  as  the  Programmes  of  Work  and  budgets  of 
the three Conventions were addressed in a joint session.  

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

of the Rotterdam, Basel and Stockholm Conventions.  

After  CoP  7,  the  Commission  presented  the  outcomes  of  the  CoP  to  DNAs  at  the  26th 
DNA  meeting  on  21  October  2015.  The  Commission  also  submitted,  together  with  the 
Presidency,  an  information  note  on  the  outcomes  of  the  CoPs  of  the  Rotterdam,  Basel 
and Stockholm Convention, transmitted by the General Secretariat of the Council to the 
delegations on 10 June 2015. In addition, all of the statements made during the CoP on 
behalf of the EU by the Commission and on behalf of the EU and its Member States by 
the  Presidency  were  published,  together  with  the  statements  made  at  the  12th  CoP  to 
the  Basel  Convention  and  the  7th  CoP  to  the  Stockholm  Convention,  through  an 
information note of the General Secretariat of the Council to delegations on 6 July 2015.  

2.3.2  Participation in committees and expert groups 

During the reporting period, the EU had five or six members nominated as experts in the 
CRC,  including  two  representatives  in  the  bureau:  Mr  Jürgen  Helbig  from  the 
Commission,  nominated  by  Spain,  who  acted  as  Chair  for  three  meetings  of  the  CRC 
during the reporting period (October 2014, October 2015 and September 2016), and Ms 
Magdalena Frydrych, nominated by Poland, acting as Vice-chair (see Table 6).  

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

CRC meetings 
CRC-10, October 2014 

CRC-11, October 2015 

EU Members of the CRC  
Ms Anja Bartels (Austria) 
Ms Parvoleta Angelova Luleva (Bulgaria) 
Ms Mirijam Seng (Germany) 
Ms Leonarda Christina van Leeuwen (Netherlands) 
Ms Magdalena Frydrych (Poland) 
Mr Jürgen Helbig (Spain) 
Ms Anja Bartels (Austria) 
Ms Parvoleta Angelova Luleva (Bulgaria) 
Ms Mirijam Seng (Germany) 
Ms Leonarda Christina van Leeuwen (Netherlands) 
Ms Magdalena Frydrych (Poland) 
Mr Jürgen Helbig (Spain) 

15 

 
 
 
 
 
CRC meetings 
CRC-12, September 2016  Ms Parvoleta Angelova Luleva (Germany) 

EU Members of the CRC  

Ms Leonarda Christina van Leeuwen (Netherlands) 
Ms Magdalena Frydrych (Poland) 
Mr Jürgen Helbig (Spain) 
Ms Johanna Peltola-Thies (UK) 

Eight  EU  experts  were  also  nominated  to  the  intersessional  working  group  on  the 
process of listing chemicals in Annex III to the Convention:  

  Mr Björn Hansen (European Commission)  
  Mr Jürgen Helbig (European Commission)  
  Ms Anja Bartels (Austria)  
  Ms Mara Curaba (Belgium)  
  Ms Jutta Emig (Germany)  
  Ms Silvija Nora Kalnins (Latvia)  
  Ms Magdalena Frydrych (Poland)  
  Mr Richard Vincent (UK)  

2.3.3  Financial contributions to the Rotterdam Convention 

As a Party to the Rotterdam Convention, the EU paid the mandatory contribution to the 
Convention’s Trust Fund and also contributed to the Special Voluntary Trust Fund for the 
implementation of the programme of work for technical assistance (see Table 7).  

Table 7: Financial contributions from the EU to the Rotterdam Convention’s Trust Fund and Special 
Voluntary Trust Fund (EUR)7 

Year 

2014 
2015 
2016 

EU contribution to Trust Fund 

51,195 
55,474 
54,582 

EU  contribution  to  Special  Voluntary 
Trust Fund 
277,331 
302,815 
513,603 

As  all  Member  States  are  Parties  to  the  Convention,  they  also  contribute  to  the 
Convention’s  Trust  Fund  through  their  mandatory  contributions  to  the  budget  of  the 
Convention  adopted  by  the  CoP.  In  addition,  some  Member  States  contribute  to  the 
Special Voluntary Trust Fund (see Table 8).  

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

Member State 
Finland 
France 
Germany 
Netherlands 
Sweden 

2014 
0 
0 
0 
84,325 
0 

2015 
79,900 
5,000 
20,000 
70,000 
23,000 

2016 
0 
0 
14,950 
61,000 
0 

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

16 

 
 
 
 
 
 
 
 
 
 
 
                                                 
3  UPDATES OF ANNEX I AND ANNEX V 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  Regulation,  the  BPR  and  the  PPPR)  and  under  the  Convention.  Annexes  to  the 
PIC Regulation are amended through delegated acts adopted by the Commission. Since 
the procedure for adoption of delegated acts is rather new, the Commission explained at 
the  23rd  and  subsequent  DNA  meetings  that  it  does  not  require  the  opinion  of  a 
comitology committee but, rather, the consultation of an expert group. That consultation 
is undertaken by presenting the draft amendment at the PIC DNA meeting and inviting 
comments  from  all  of  the  Member  State  experts  present,  together  with  other 
stakeholders. In addition, the delegated act adopted by the Commission is submitted to 
the European Parliament and the Council, and only enters into force if neither objects.  

3.1  Update of Annex I  

Amendments  to  Parts  1  and  2  of  Annex  I  are  triggered  by  regulatory  actions  changing 
the legal status of a substance under other relevant EU legislation, in particular: 

  Decision not to approve or to withdraw an active substance under the PPPR;  
  Decision not to approve or to withdraw an active substance under the BPR;  
  Decision to subject  a chemical to authorisation by adding it to the Authorisation 

List (Annex XIV) of the REACH Regulation;  

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

Regulation.  

During  the  reporting  period,  two  Delegated  Regulations  amending  Annex  I  were 
adopted,  in  2014  and  2015  (see  Table  9).  Of  the  substances  added  to  Annex  I,  many 
were  proposed  for  inclusion  in  Parts  1  and  2  of  Annex  I  of  the  PIC  Regulation  having 
been already banned for use as pesticides under Regulation (EC) No 1107/2009. This is 
the case for bitertanol, cyhexatin, azocyclotin, cinidon-ethyl, cyclanilide, ethoxysulfuron, 
oxadiargyl,  didecyldimethylammonium  chloride,  and  warfarin  in  2014,  and  fenbutatin 
oxide  in  2015.  In  addition,  substances  severely  restricted  as  pesticides,  such  as 
rotenone and cyfluthrin, were added to Annex I in 2014.  

Lead  compounds,  dibutyltin  compounds,  dioctyltin  compounds,  trichlorobenzene, 
pentachloroethane, 
1,1,2-
trichloroethane  and  1,1-dichloroethene  were  added  to  Annex  I  in  2015,  as  these  are 
severely restricted as industrial chemicals for public use, in accordance with REACH.  

1,1,1,2-tetrachloroethane, 

1,1,2,2-tetrachloroethane, 

perfluorooctane 

Amendments  to  Part  3  of  Annex  I  reflect  the  decision  of  the  CoP  to  include  certain 
chemicals  in  Annex  III  of  the  Convention,  making  them  subject  to  the  PIC  procedure. 
sulfonates, 
Azinphos-methyl, 
sulfonic 
perfluorooctane 
commercial 
pentabromodiphenyl  ether,  including  tetra-  and  pentabromodiphenyl  ether,  as  well  as 
commercial  octabromodiphenyl  ether,  including  hexa-  and  heptabromodiphenyl  ether 
were included in Part 3 of Annex I during the reporting period, following their inclusion 
in Annex III to the Rotterdam Convention.  

perfluorooctane 

perfluorooctane 

sulfonamides 

sulfonyls, 

acid, 

and 

17 

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

Delegated Act 

Chemical  

Commission 
Delegated 
Regulation 
(EU) 
No  1078/2014  of 
7  August  2014 
amending Annex I 
to Regulation (EU) 
No 649/2012 

Commission 
Delegated 
Regulation 
(EU) 
2015/2229  of  29 
September  2015 
amending Annex I 
to Regulation (EU) 
No 649/2012 

Azocyclotin  
Bitertanol 
Cinidon-ethyl 
Cyclanilide  
Cyfluthrin 
Cyhexatin 
Ethoxysulfuron 
Didecyldimethylammonium 
Chloride 
Oxadiargyl 
Rotenone  
Warfarin 
Azinphos-methyl 
Perfluorooctane sulfonic acid 
Perfluorooctane sulfonates 
Perfluorooctane sulfonamides 
Perfluorooctane sulfonyls 
1,1-Dichloroethene 
1,1,2-Trichloroethane 
1,1,1,2-Tetrachloroethane 
1,1,2,2-Tetrachloroethane 
Dibutyltin compounds 
Dioctyltin compounds 
Fenbutatin oxide 
Lead compounds 
Pentachloroethane 
Trichlorobenzene 
Commercial 
pentabromodiphenyl ether, 
including: tetrabromodiphenyl 
ether, and pentabromodiphenyl 
ether 
Commercial octabromodiphenyl 
ether, including 
hexabromodiphenyl ether and 
heptabromodiphenyl ether 

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

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

for 

Basis 
inclusion  
PPPR  
PPPR  
PPPR  
PPPR  
PPPR  
PPPR  
PPPR  
PPPR  

PPPR  
PPPR  
PPPR  
Annex III to RC 
Annex III to RC 
Annex III to RC 
Annex III to RC 
Annex III to RC  
REACH 
REACH 
REACH 
REACH 
REACH 
REACH 
PPPR 
REACH 
REACH 
REACH 
Annex III to RC 

Part 3 

Annex III to RC 

18 

 
 
 
 
 
 
The  inclusion  of  other  substances  in  Annex  I  was  discussed  in  2016,  but  has  not  yet 
been formally adopted through a Delegated Regulation (see Table 10).  

Table 10: Chemicals proposed for inclusion in Annex I  

Chemical 
Tepraloxydim 
Carbendazim 
Triflumuron 
Triclosan  
cybutryne 
2,4-dinitrotoluene 
4,4’-
diaminodiphenylmethane 
(MDA) 
5-tert-butyl-2,4,6-trinitro-
m-xylene 
benzyl butyl phthalate 
Diisobutyl phthalate 
Diarsenic  pentaoxide  and 
tris(2-chloroethyl) 
phosphate 
Methamidophos 

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

Basis for inclusion  
PPPR 
PPPR 
BPR 
BPR  
BPR 
REACH 
REACH 

Part 1 and 2 

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

REACH 

REACH 
REACH 
REACH 

Part 1 and 3 

Annex III to RC 

3.2  Updates of Annex V  

At the 27th meeting of the DNAs in April 2016, an amendment to Annex V was discussed 
– the inclusion of hexabromocyclododecane in Part 1 of Annex V of the PIC Regulation. 
Hexabromocyclododecane has been included in Part A of Annex I to Regulation (EC) No 
850/2004  (Persistent  Organic  Pollutants  (POPs)  Regulation),  since  the  decision  was 
taken under the Stockholm Convention to list this chemical in Part 1 of Annex A to the 
Stockholm Convention. It should therefore be listed in Annex V of the PIC Regulation. 

19 

 
 
 
 
 
4  OPERATION OF THE PIC REGULATION  

4.1  Support to exporters and importers 

The Agency is required to provide assistance, as well as technical and scientific guidance 
and tools, to exporters and importers (Article 6(1)). Although it is not a legal obligation 
under the PIC Regulation, most DNAs have provided support and carried out awareness-
raising activities for national exporters and importers during the reporting period.  

Both  the  Agency  and  Member  States  were  asked  to  provide  information  (in  their 
respective  reporting  questionnaires)  on  the  awareness-raising  and  communication 
activities  carried  out  during  the  reporting  period  and  requests  received  from  exporters 
and importers (Section 3 of Member State and the Agency’s questionnaires).  

Both  DNAs  and  the  Agency  stated  that  the  support  provided  to  companies,  as  well  as 
the  awareness-raising  activities  carried  out  during  the  reporting  period,  had  improved 
exporter and importer compliance with the PIC Regulation. 

4.1.1  Support provided by DNAs  

Awareness-raising activities  
Twenty-five  Member  States  stated  that  they  had  carried  out  awareness-raising  and 
information activities for exporters and importers during the reporting period (see Figure 
2). Member States that did not carry  out any  such activities were  either  small Member 
States with little or no exports and imports falling within the scope of the Regulation, or 
Member States providing information to exporters and importers on request.  

The most common activities carried out by Member States were the provision of online 
information,  such  as  a  specific  webpage  providing  information  on  the  PIC  Regulation, 
and  references  to  the  Agency’s  webpages  on  PIC  and  ePIC.  Ten  Member  States  also 
provide a national helpdesk.  

Other  awareness-raising  activities  carried  out  by  Member  States  included  mail  or 
telephone  correspondence  between  the  DNA  and  importers  or  exporters,  guidelines  for 
importers  and  exporters,  and  information  spread  through  the  Strategic  Approach  to 
International Chemicals Management (SAICM) Platform.  

Almost  all  of  the  Member  States  carrying  out  awareness-raising  and  information 
provision  activities  considered  such  activities  to  have  improved  exporter  and  importer 
compliance with the PIC Regulation. For example, some DNAs noted an increase in the 
number  of  export  notifications  received  by  the  DNA  during  the  reporting  period,  an 
increase  in  the  number  of  companies  registered  in  ePIC,  or  improved  compliance  with 
the Article 10 reporting obligations.  

20 

 
 
 
 
 
 
 
 
 
 
Figure 2: Question 11. Have any awareness-raising and information activities been put in place by 
the DNA(s) to support exporters and importers to comply with the PIC Regulation?  

Specific web page providing information on the PIC…

Reference to ECHA webpages on PIC and ePIC

National helpdesk

Specific email address for information requirements

Workshops and similar training events

Online technical and scientific guidance (other than…

Others

Awareness-raising campaign

Visits to operator establishments

Social media

0

5

10

15

20

25

Number of Member States 

Requests from exporters and importers  
The  most  frequent  requests  from  exporters  and  importers  to  DNAs  relate  to  export 
notifications and explicit consents (see Figure 3).  

Estimated amount of time spent on support  
In  the  majority  of  Member  States,  providing  support  to  exporters  and  importers  takes 
less than 10% of the DNA’s working time. This rises to 40% in three Member States.  

Figure 3: Question 13. On which matters do(es) the DNA(s) get the two most frequent requests for 
support coming from exporters and importers? 

Export notification

Explicit consent

Special RIN

Article 10 reporting

Others

Waiver

0

5

10

15

20

25

30

Number of Member States  

4.1.2  Support provided by the Agency  

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

Technical and scientific guidance 
The Agency published version 1.0 of the Guidance for implementation of Regulation (EU) 
No  649/2012  concerning  the  export  and  import  of  hazardous  chemicals  (‘Guidance  on 

21 

 
 
 
 
 
 
 
 
PIC’)  in  December  2014  (in  English  only)  and  a  corrigendum  to  it  (version  1.1)  in  July 
2015  (to  take  into  account  the  end  of  certain  CLP  transition  periods).  Translations  of 
version  1.1  into  14  languages  (Bulgarian,  Croatian,  Czech,  Danish,  Dutch,  German, 
Finnish,  French,  Spanish,  Italian,  Polish,  Portuguese,  Slovenian  and  Swedish)  were 
published in March 2016, with translations into the remaining eight official EU languages 
(Estonian,  Greek,  Hungarian,  Latvian,  Lithuanian,  Maltese,  Romanian  and  Slovak) 
published in October 2016. 

Webpages on the PIC Regulation and ePIC 
the  PIC  Regulation 
The  Agency  has 
(https://echa.europa.eu/regulations/prior-informed-consent-regulation)  and  a  webpage 
dedicated  to  ePIC  (https://echa.europa.eu/support/dossier-submission-tools/epic).  These 
pages are in all official EU languages.  

specific  webpage  on 

created  a 

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

  To remind exporters/importers of upcoming legal deadlines; 
  To advertise publication of updated user manuals, new factsheets, etc.; 
  To inform of policy changes; 
  To alert users in advance of maintenance breaks. 

Awareness-raising campaign 
The  Agency  reminds  exporters  and  importers  of  PIC-related  news,  such  as  upcoming 
legal  deadlines  or  workload  peaks,  using  different  communication  means,  including  the 
weekly  e-News  and  the  Agency  Newsletter.  These  channels  are  also  used  to  highlight 
new substances added to Annex I or included in group entries. 

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

Workshops, webinars and similar training events 
The  Agency  has  organised  a  number  of  workshops  on  PIC,  mainly  related  to  the  initial 
development of ePIC:  

  Three  workshops  for  Member  States  and  industry  representatives  organised  at 
the  Agency’s  premises  during  the  development  of  ePIC  (June  2013,  November 
2013  and  May  2014)  in  order  to  gather  their  feedback  and  invite  their 
contributions to the application specifications.  

  WebEx discussions during the development of the ePIC system. 
  Training  workshop  organised  at  the  Agency’s  premises  in  September  2014,  just 
after  the  launch  of  the  ePIC  system,  to  instruct  users  on  the  use  of  ePIC 
application.  

In  addition,  the  Agency  takes  part  in  conferences  and  training,  seeing  them  as  an 
opportunity  to  reach  out  to  industry  directly,  to  provide  updates  on  ePIC  and  policy 
issues, and to address specific concerns.  

IT user manuals, factsheets and Q&A (FAQs) 
After the launch of ePIC, the Agency published a user manual, which was subsequently 
translated into all official EU languages and is updated every time there is a new release 
of the application. The Agency has also prepared factsheets dedicated to specific topics 
and has a Q&A document on ePIC, which is updated in parallel with new releases of the 
application. 

According  to  the  Agency,  these  activities  have  improved  exporter  and  importer 
compliance  with  the  PIC  Regulation.  Similarly,  it  partially  attributes  the  increase  in  the 
number  of  companies  registered  in  ePIC  (390  in  March  2014  compared  to  1177  at  the 
end of the reporting period) to the awareness-raising activities and the visibility given to 
ePIC. 

22 

 
 
 
 
 
 
 
 
 
Requests from exporters and importers  
Through its helpdesk, the Agency received 123 requests for information or support from 
exporters and importers in 2014, 245 in 2015 and 227 in 2016.  

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

  Scope-related issues: which chemicals are subject to the PIC Regulation;  
  Reasons why an export has not been allowed to proceed;  
  Exporters’ obligations under the PIC Regulation, as determined by the listing of a 

chemical in Annex I; 

  Clarification  on  which  Member  State  shall  receive  the  export  notification  (e.g. 
where the legal entity holding the contract for an export is in one Member State 
but the shipment is leaving from a different Member State);  

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

quarter of each calendar year.  

In addition, the Agency received a low number of more complex questions, e.g. the link 
between  the  PIC  Regulation  and  other  legislation,  the  triggering  of  labelling  obligations 
for  mixtures  under  CLP,  or  the  responsibility  for  the  export  notification  when  the 
manufacturer  is  based  outside  the  EU  but  chemicals  are  shipped  from  the  EU  to  third 
countries. 

Estimated amount of time spent on such support  
Four FTEs working in the Dossier Submission & PIC Unit provide replies to the requests 
received from companies. This task takes approximately 10% of their time, on average. 

4.2  Export  notifications  forwarded  to  Parties  and  other  countries 

(Article 8) 

The  export  notification  is  the  instrument  under  the  PIC  Regulation  by  which  countries 
exchange  information  on  banned  or  severely  restricted  chemicals.  All  EU  based 
exporters  must  submit  an  export  notification  to  their  DNA  if  they  intend  to  export 
chemicals listed  in  Part  1  of  Annex  I  to  the  PIC  Regulation  to  a  third country  (Party  or 
non-Party  to  the  Rotterdam  Convention),  irrespective  of  the  use  of  the  chemical in  the 
country  of  destination.  Once  the  DNA  has  checked  and  accepted  the  notification  (after 
resubmission  if  necessary),  it  is  forwarded  to  the  Agency,  which  also  verifies  the 
compliance of the notification and transmits it to the DNA of the importing country. If no 
acknowledgement of receipt is received, the Agency re-sends the notification. The whole 
procedure  is  carried  out  by  means  of  ePIC,  and  exporters  must  use  the  notification 
template provided by the system.  

DNAs and the Agency were asked to provide data on the number of export notifications 
and  Special  RIN  requests  processed  during  the  reporting  period,  information  on 
difficulties  encountered  by  exporters  and  authorities  in  carrying  out  the  procedures, 
emergency situations, and the provision of additional information on exported chemicals.  

The  number  of  export  notifications  and  Special  RIN  requests  increased  between  2014 
and  2016,  and  their  number  varied  significantly  between  Member  States.  According  to 
the Agency, this shows that compliance has increased during the reporting period. In a 
relatively  high  number  of  cases,  the  DNAs  or  the  Agency  requested  resubmission  of  a 
notification,  usually  relating  to  issues  with  section  6  of  the  notification  form  (summary 
of, and reasons for, the FRA and date of entry into force) and to the SDS (inappropriate 
language  or  SDS  not  matching  the  notification).  Although  some  DNAs  and  the  Agency 
reported  problems  in  complying  with  the  timeframes  of  the  notification  procedure,  the 
number of notifications processed late remained low.  

23 

 
 
 
 
 
 
 
 
4.2.1  Export notifications processed during the reporting period8  

During  the  reporting  period,  DNAs  accepted  and  forwarded  to  the  Agency  15,771 
notifications, and rejected 1,214 notifications9.  

The  number  of  export  notifications  processed  varies  significantly  between  Member 
States (see Figure 4). Four Member States did not process any export notification during 
the  reporting  period  (Latvia,  Lithuania,  Luxembourg  and  Slovakia)  and  five  Member 
States  processed  fewer  than  10  notifications.  The  highest  numbers  of  export 
notifications  during  the  reporting  period  were  in  Germany  (5,196  notifications),  France 
(3,358), the UK (1,829), Italy (1,321) and Spain (1,265). The importing countries that 
received  the  highest  numbers  of  export  notifications  from  the  EU  were  Switzerland 
(1,044 notifications), Turkey (984), Russia (890), the USA (754) and China (601). 

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

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10

1

The  number  of  export  notifications  accepted  and  forwarded  to  the  Agency  by  DNAs 
increased  significantly  during  the  reporting  period,  from  1,553  in  2014,  to  5,866  in 
2015, to 8,352 in 201610 (see Table 11).  

8 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.  

9 Figures provided by DNAs include rejected/re-submitted notifications, in addition to ‘validated’ notifications 

(i.e. accepted and processed). 

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

March 2014). 

24 

 
 
 
 
 
 
 
 
 
                                                 
 
 
 
 
The Agency also reported an increase in the number of export notifications accepted and 
processed during the reporting period, from 4,575 in 2014, to 5,460 in 2015, to 7,967 in 
201611, thus beyond the 10% increase originally envisaged (see Table 11). The number 
of  companies  involved  in  PIC  activities  has  also  increased  substantially,  from  390  in 
2014 to 1,177 in 201612. The Agency  concluded from this increase that awareness and 
compliance  with  the  Regulation  has  significantly  improved  during  the  reporting  period. 
The  main  factor  that  contributes  to  this  increase  is  the  inclusion  of  new  chemicals  in 
Annex  I.  Table  11Error!  Reference  source  not  found.  summarises  the  activities 
carried out by the Agency in relation to export notifications during the reporting period.  

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

handled 
submissions, 

notifications 
initial 

Export 
(including 
resubmissions and rejections) 
Export notifications forwarded 
Acknowledgments of receipt received 
Export  notifications 
second time 

forwarded  a 

2014 
1,55013 

2015 
5,845 

460 
190 
270 

4,642 
3,077 
1,565 

2016 
8,335 

7,229 
4,575 
2,654 

An  acknowledgement  of  receipt  is  requested  by  the  Agency  for  all  export  notifications 
sent (not just the first one after Annex I inclusion, as stated in Article 8(3)), as this is an 
important  means  of  ensuring  that  the  information  has  been  received,  especially  as 
contact details in non-EU countries change frequently.  

4.2.2  Special RIN requests processed during the reporting period  

Exporters  of  chemicals exported for research  or analysis purposes in quantities that do 
not  exceed  10kg  from  each  exporter  to  each  importing  country  per  calendar  year  use 
the  Special  RIN  request  procedure,  in  which  the  exporter  requests  a  Special  RIN  from 
the  DNA.  If  the  request  is  accepted,  this  activates  a  Special  RIN  that  the  exporter  can 
use on the customs declaration. The Special RIN request procedure is also used in cases 
where  the  exporter  is  exempt  from  export  notifications,  such  as  emergency  situations, 
when  a  positive  import  response  has  been  given  by  the  importing  party  and  when  a 
country has waived its right to be notified.  

During  the  reporting  period,  17  Member  States  accepted  7,072  Special  RIN  requests. 
Eleven  Member  States  did  not  have  to  deal  with  any  such  request  in  the  past  three 
years  (Bulgaria,  Cyprus,  Estonia,  Greece,  Hungary,  Latvia,  Lithuania,  Luxembourg, 
Malta, Romania, and Slovakia). Germany, the UK and Belgium were the Member States 
that accepted the highest number of Special RIN requests (see Figure 5).  

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

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

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

ECHA/PR/17/15, 6 September 2017: https://echa.europa.eu/-/increase-in-notifications-providing-
information-on-the-export-of-hazardous-chemicals  

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

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

25 

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

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4.2.3  Requests 

for 

resubmission  and 

rejection  of  export 

notifications  

Member  States  requested  the  resubmission  of  2,904  export  notifications  during  the 
reporting period. Figure 6 shows the significant variations between Member States.  

Figure  6:  Total  number  of  resubmissions  of  export  notifications  requested  by  DNAs14  in  the 
reporting period 

525 

327 

287 

242 

1173 

France
Germany
Spain
United Kingdom
Italy
Belgium
Austria
Denmark
Finland
Netherlands
Poland
Portugal
Hungary
Bulgaria
Ireland

79 
77 

48 
30 
23 
17 
15 
15 
15 
14 

0

200

400

600

800

1000

1200

1400

Total number of resubmissions requested by DNAs 

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

graph.  

26 

 
 
 
 
 
 
 
 
 
                                                 
 
 
 
 
 
 
DNAs  explained  that  resubmission  of  notifications  were  necessary  where  information 
requirements  were  not  met.  Several  DNAs  further  specified  the  missing  or  incorrect 
information typically triggering the request for resubmission:  

 

 

 

 

Information  requirements  not  met  in  section  6  of  the  export  notification  form  – 
summary of, and reasons for, the FRA and date of entry into force (five DNAs).  
Information  requirements  not  met  in  section  1  of  the  export  notification  form  – 
identity  of  the  chemical  subject  to  the  export  notification:  CAS  number, 
concentrations, name of product (one DNA).  
Information  requirements  not  met  in  section  3  of  the  export  notification  form  – 
information  concerning  the  export,  e.g.  phone  number,  importer  address  (one 
DNA). One DNA also reported that in some cases exporters incorrectly ticked the 
emergency situation box in order to avoid the 35-day waiting period.  
Information  requirements  not  met  in  section  4  of  the  export  notification  form  – 
information on hazards and/or risks of the chemical and precautionary measures, 
e.g. wrong classification (one DNA).  

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

  The SDS was not submitted in the correct language (five DNAs).  
  The SDS did not match the export notification (four DNAs). Two DNAs specifically 
mentioned  inconsistencies  in  the  composition  of  mixtures.  Italy  also  pointed  to 
cases where the type of product (substance / mixture) was different on the SDS 
and notification form.  

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

The Agency requested the resubmission of 609 export notifications during the reporting 
period (43 in 201415, 334 in 2015, and 232 in 2016). The main reasons for requesting 
resubmission of a notification were:  

 

Issues  with  the  data  provided  in  Section  6.1  ‘Summary  of  and  reasons  for  the 
final regulatory action and date of entry into force’ (incorrect text/language). 
  Problems  with  the  SDS:  incorrect  SDS  attached  to  the  notification;  SDS 
unavailable  because  attached  in  the  incorrect  place  in  ePIC;  SDS  language 
incorrect. 

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

and on the SDS. 

Member States rejected 1,214 export notifications during the reporting period.  Figure 7 
shows the numbers of rejected notifications for those Member States in which rejections 
occurred most frequently.  

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

27 

 
 
 
 
 
                                                 
Figure 7: Total number of export notifications rejected by DNAs during the reporting period16  

205 

United Kingdom

Spain

France

Germany

Belgium

Italy

99 

84 

42 

32 

Netherlands

20 

692 

0

100

200

300

400

500

600

700

800

Total number of notifications rejected by DNAs 

12 Member States stated that export notifications were rejected because they were not 
applicable for the following reasons:  

  Duplication of notifications (10 DNAs).  
  The resubmission occurred too late (one DNA). 
  The emergency situation was not justified (one DNA).  
  Conditions for granting a special RIN were met (two DNAs).  
  Rejection requested by exporting company (two DNAs).  
  PIC chemical missing in mixture (one DNA).  

Other  Member  States  indicated  that  rejection  was  based  on  flaws  in  the  export 
notification:  

 

Information  requirements  not  met  or  incorrect  information  provided  (three 
DNAs). 

  Wrong  identification,  e.g.  substance  notified  as  mixture  and  vice  versa  (one 

DNA).  

  Missing SDS in appropriate language (two DNAs).  

Finally,  one  DNA  pointed  to  cases  where  a  notification  was  rejected  because  of  the 
negative consent received from the importing country.   

The Agency rejected 175 notifications during the reporting period (51 in 2015 and 124 in 
2016).  In  2015,  a  large  number  of  export  notifications  for  didecyldimethylammonium 
chloride  were  rejected  because  the  substance  was  notified  in  a  mixture  at  a 
concentration  level  which  did  not  trigger  labelling  of  the  mixture,  irrespective  of  the 
presence  of  any  other  substance  (in  accordance  with  Article  8(1)).  In  2016,  124 
notifications  were  rejected  because  the  importing  country  had  waived  the  requirement 
to receive  export notifications for exports of certain chemicals from the EU,  or because 
the  mixture  was  not  classified  as  hazardous,  based  on  the  information  provided  in  the 
SDS. 

4.2.4  Difficulties encountered in the export notification procedure  

Difficulties encountered by exporters in completing the export notification form 

According to the Agency and DNAs,  exporters  have experienced difficulties in providing 
information on the export (e.g. contact details of importers) and the intended use of the 
chemical in the importing country (see Figure 8).  

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

28 

 
 
 
 
 
 
 
 
                                                 
Figure 8: Question 19. What are the information requirements requested in the export notification 
form where exporters have difficulties in providing the information?  

Availability of CN codes or CUS codes

Information concerning the export (e.g. contact details…

Intended use of the chemical in the importing country

Information on the final regulatory action taken by the…

None

Summary of and reasons for final regulatory action and…

Additional information provided by the exporting Party

Identity of the mixture to be exported

Information on hazards or risks of the chemical and…

Identity of the substance to be exported

Summary of physico-chemical, toxicological and…

Identity of the article to be exported

0

2

4

6

8

10
Number of Member States 

12

14

In addition, the Agency indicated that the identity of the substance to be exported and 
the summary of, and reasons for, the FRA and date of entry into force had also proved 
problematic  for  exporters.  Twelve  DNAs  also  stated  that  the  availability  of  Combined 
Nomenclature  (CN)  or  Customs  Union  and  Statistics  (CUS)  codes  were  a  particular 
problem for exporters.  

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

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

issue for some exporters.  

  One  DNA  stated  that  the  grouping  of  chemicals  was  a  particular  problem,  and 
that  biocides  were  sometimes  considered  industrial  chemicals  and  other  times 
pesticides.  

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

and applications for Special RIN requests.  

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

scope of the Regulation.  

The Agency also noted the following problems or mistakes:  

 

If their chemical is not in ePIC, companies are not sure whether or not its export 
is  subject  to  the  PIC  Regulation  (this  issue  relates  specifically  to  group  entries, 
e.g.  cadmium  and  its  compounds,  for  which  the  list  of  cadmium  compounds  in 
ePIC is not comprehensive). 

  Some exporters confuse export notifications for substances and mixtures. 
  Section  3.1  of  the  export  notification  (foreseen  category  and  foreseen  use  in 
importing country) is often confused with section 6.2 (category for which the FRA 
was taken). 

  The  intended  use  and  use  category  for  exports  of  biocides  can  be  problematic 
due  to  the  fact  that  the  EU  considers  ‘biocides’  to  be  a  sub-category  of  the 
pesticides category, whereas many non-EU countries consider biocides industrial 
chemicals. 

29 

 
 
 
 
 
 
  Some companies insert controversial, non-factual messages in section 6.1 on the 
FRA (e.g. they disagree with the fact that the substance was banned or severely 
restricted in the EU) that are not acceptable, and the Agency has to ask for such 
statements to be removed. 

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

language of the importing country or in an appropriate language. 

  The  definition  of  an  exporter  (Article  3(18))  was  not  always  easily  applicable  to 
certain  cases  in  which, for  example,  the  holder  of  the  contract  was  in  a  non-EU 
country (Switzerland) but the export was physically shipped from the EU.  

  The  obligation  to  notify  the  export  of  an  article  is  set  out  in  Article  15,  in 
conjunction  with  Article  3(4).  It  was  often  unclear  to  exporters,  DNAs  and  the 
Agency whether or not a given article is subject to the PIC Regulation. 

Complying with timeframes  

According  to  the  Agency,  some  DNAs  experienced  difficulties  in  coping  with  the 
timeframe  to  forward  the  export  notifications.  However,  the  number  of  export 
notifications  it  received  less  than  25  days  before  the  export  remains  relatively  low 
compared  to  the  total  number  of  notifications  processed  (725,  or  4.9%  of  the  total 
number of notifications).  

Seven Member States stated that they experienced such difficulties during the reporting 
period.  In  particular,  four  Member  States  indicated  that  they  have  difficulties  in 
complying  with the  timeframes  during  the  ‘peak  season’  in  winter.  Two  Member  States 
mentioned that companies did not respect deadlines for resubmission, thereby delaying 
the whole procedure. The Agency explained that where  the exporter had submitted the 
export notification on time and the delay was in fact due to late processing by the DNA, 
they processed the late export notification in order not to further penalise the exporter 
and to allow the export process to continue. The Agency added that the authority in the 
importing  country  is  always  alerted  by  a  separate  communication  where  an  export 
notification  was  delivered  less  than  15  days  before  the  expected  date  of  export  (as 
foreseen by Article 8(2) of the PIC Regulation). 

The Agency indicated that it, too, experienced difficulties in coping with the timeframe to 
process and forward export notifications to the importing country. However, the number 
of  late  notifications  remains  very  low.  171  notifications  were  sent  late to  the  importing 
countries,  around  1.2%  of  the  total  number  of  export  notifications  forwarded  to 
importing countries during the reporting period. This is mostly due to delays in receiving 
the  notifications  from  the  DNAs.  In  30  cases,  however,  the  delay  was  caused  by  the 
Agency itself, mainly because of IT issues. According to the Agency, the authority in the 
importing country is always informed accordingly.  

4.2.5  Emergency situations (Article 8(5)) 

According  to  Article  8(5),  when  the  export  relates  to  an  emergency  situation  in  which 
any delay may endanger public health or the environment in the importing country, the 
DNA,  in  consultation  with  the  Commission,  may  exempt  the  exporter  from  the 
notification requirements or the waiting period. According to the Agency and the DNAs, 
only a small number of export notifications referred to an emergency situation, most of 
which did not meet Article 8(5) criteria and were rejected. Only two DNAs (Belgium and 
Greece)  stated  that  they  had  to  deal  with  an  emergency  situation  during  the  reporting 
period.  In  Belgium,  the  export  notification  was  rejected  as  it  did  not  meet  Article  8(5) 
criteria. In Greece, the emergency situation concerned 1,3-dichloropropene imported by 
Turkey, requesting a 120-day authorisation to use the chemical as a soil fumigant.  

30 

 
 
 
 
 
 
4.2.6  Provision  of  available  additional  information  on  exported 

chemicals 

According  to  Article  8(7),  the  Commission,  DNAs,  the  Agency  and  exporters  should 
provide  additional  information  on  the  exported  chemicals,  at  the  request  of  the 
importing  party.  The  Agency  received  many  requests  to  provide  additional  information 
or  clarifications  on  exported  chemicals  to  importing  parties  and  other  countries.  These 
typically related to additional information on the importing company, clarification on the 
intended  use  of  the  chemical  in  the  importing  country  or  on  the  quantities  exported, 
clarification on the reasons for notifying the export of the chemical or for requesting the 
explicit  consent  for  chemicals  which  are  not  listed  in  Annex  III  to  the  Rotterdam 
Convention, and cases where the export notification was sent to the wrong authority.  

Eight DNAs received similar requests. Information requested by the importing countries 
related primarily to importer contact details. Other requested information related to the 
chemical itself, e.g. name of the chemical, or information on the reasons for its ban or 
restriction in the EU.  

4.2.7  Administrative fee for export notifications 

Member States are allowed to establish administrative fees for exporters for each export 
notification  and  for  each  request  for  explicit  consent  made,  corresponding  to  the  cost 
they  incur  in  carrying  out  the  procedures.  Eight  Member  States  request  an 
administrative fee for export notifications, and these fees vary greatly between Member 
States (from EUR 25 to  EUR 250).  Three Member States  request a fee for requests for 
explicit  consent.  Member  States  received  no  complaints  from  exporters,  nor  did  they 
note any significant impact of the fee on the number of export notifications.  

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

As per Article 9, the Agency must make available on its database the export notifications 
it receives from third countries, acknowledge receipt of the notification to the DNA of the 
exporting country and provide a copy to the DNA of the Member State(s) receiving the 
import.  The  Agency  was  asked  to  provide  information  on  the  export  notifications 
received and acknowledgements sent.  

The  Agency  received  1,105  export  notifications  from  non-EU  countries  in  the  reporting 
period  (see  Table  12).  The  number  of  notifications  almost  doubled  between  2014  and 
2016.  

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

Export notifications received  
Acknowledgements sent 

2014 
209 
317 

2015 
486 
122 

2016 
410 
92 

Total  
1,105 
217 

The  difference  between  the  number  of  notifications  received  and  the  number  of 
acknowledgements  sent  is  due  to  the  fact  that  the  Agency  does  not  send 
acknowledgements  of  receipt  to  the  US,  based  on  a  bilateral  agreement  between  the 
two parties, while the US is the country sending the greatest number of notifications to 
the EU.  

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

31 

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

Article  10  places  obligations  on  exporters  and  importers  to  inform  the  DNA  of  the 
quantity  of  chemicals  listed  in  Annex  I  of  the  PIC  Regulation  exported  to  or  imported 
from  third  countries  during  the  preceding  year.  This  must  be  done  during  the  first 
quarter  of  each  year.  Exporters  must  also  provide  the  DNA  with  the  names  and 
addresses of each importer. DNAs must, in turn, provide this information to the Agency 
annually, which then aggregates the data at EU level and makes it publicly available on 
its database.  

DNAs and the Agency were asked (in their respective questionnaires) about any delays 
and  difficulties  encountered  in  fulfilling  their  obligations  under  Article  10.  Their 
responses suggest that the reporting under Article 10 works well.   

Delays in collecting information  
Ten  DNAs  stated  that  several  exporters  had  delayed  the  submission  of  information  on 
the quantity of the chemicals exported, but said that exporters generally submitted the 
information after a reminder. Eight DNAs stated that they had experienced delays from 
importers in submitting their information. These delays did not affect the completion of 
the reporting exercise  under Article 10, as the Agency did not encounter similar delays 
from DNAs in receiving the aggregated national reports on the quantity of exported and 
imported chemicals.  

Reporting through ePIC  
Very few DNAs reported problems with reporting through ePIC, with only two indicating 
that  they  had  experienced  difficulties  in  their  Article  10  reporting.  Two  DNAs  indicated 
that they experienced delays in submitting aggregated information through ePIC.  

Aggregating information at EU level  
According  to  the  Agency,  the  aggregation  of  information  was  complicated  by  incorrect 
reporting by some DNAs, which had included data on exports of PIC chemicals exported 
for  research  and  analysis  purposes  (below  10kg  per  year  and  per  importing  country). 
These exports are out of the scope of Article 10 and should not be reported by DNAs.  

Use of Article 10 data  
Data gathered for the purposes of Article 10 reporting are used by the DNAs, customs or 
other enforcement authorities in 16 Member States. Eight DNAs indicated that the data 
are  used  for  enforcement  activities,  with  six  specifying  that  it  is  used  for  REACH 
enforcement  activities  (e.g.  cross-checking  compliance  with  registration  requirements, 
or checking compliance with restrictions).  

4.5  Notification  of  banned  or  severely  restricted  chemicals  under  the 

Convention (Article 11-12) 

As  per  Article  11  of  the  PIC  Regulation,  the  Commission  must  notify  the  Secretariat  of 
the Rotterdam Convention, in writing, of the chemicals listed in Part 2 of Annex I, which 
qualify  for  PIC  notification.  The  Commission,  assisted  by  the  Agency,  drafted  the 
notifications and submitted these to the DNAs for comments before submitting them to 
the  Secretariat.  Three  notifications  were  submitted  to  the  Secretariat  during  the 
reporting period (see Table 13). 

32 

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

Basis for notification  
Commission  Regulation  (EC)  No  73/2013 
(2014) 
Commission  Delegated  Regulation  (EU) 
No 1078/2014 
Chemicals notified after inclusion in Annex 
Commission  Delegated  Regulation  (EU) 
No 2015/2229  

Chemicals notified  
Naled 

Date of notification 
2014 

Bitertanol 

October 2016 

Fenbutatin oxide 

October 2016 

4.6  Obligations in relation to importing chemicals (Article 13) 

As  per  Article  10  of  the  Convention,  Parties  are  requested  to  adopt  an  import  decision 
for each new chemical listed in Annex III and to submit it to the Secretariat within nine 
months of receipt of the notification of the listing and the decision guidance document. 
Pursuant to Article 13 of the PIC Regulation, the import decision is adopted by means of 
an  implementing  act.  The  Commission  drafts  the  implementing  act  containing  relevant 
import  decisions,  which  is  then  submitted  to  the  REACH  Committee  for  an  opinion,  in 
accordance with the advisory procedure. 

During the reporting period, the Commission adopted two Implementing Decisions (see 
Table  14).  In  2014,  the  Commission  drafted  import  decisions  for  azinphos-methyl, 
commercial  pentabromodiphenyl  ether, 
commercial  octabromodiphenyl  ether, 
perfluorooctane  sulfonic  acid,  perfluorooctane  sulfonates,  perfluorooctane  sulfonamides 
and  perfluorooctane  sulfonyls,  which  were  submitted  to  the  REACH  Committee  on  7 
April,  with  the  Commission  Implementing  Decision  adopted  on  15  May  2014.  In  2015, 
the  Commission  drafted  a  new  import  decision  for  methamidophos  and  revised  the 
import  decisions  on  DDT  and  ethylene  oxide,  which  were  submitted  to  the  REACH 
Committee in late 2015. The Implementing Decision was adopted on 11 February 2016.  

Table 14: EU import responses adopted during the reporting period  

Implementing 
Act 
Commission 
Implementing 
Decision of 15 
May 2014 

Chemicals 

Nature  /  status  of 
decision  

Azinphos-methyl   New 

Final  

Commercial 
pentabromodiph
enyl ether  

decision 
New 
decision 

Final  

Commercial 
octabromodiphe
nyl ether  

New 
decision 

Final  

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

Consent to 
import only 
subject to 
specified 
conditions 

New 
decision 

Final  

No consent 
to import 

acid, 

Perfluorooctane 
sulfonic 
perfluorooctane 
sulfonates, 
perfluorooctane 
sulfonamides 
and 
perfluoro-
octane sulfonyls  

Grounds for 
decision 
Banned  for  use 
under PPPR 
Banned for use, 
subject to 
specific 
exemptions 
under POPs 
Regulation  
Banned for use, 
subject to 
specific 
exemptions 
under POPs 
Regulation  
Banned for use, 
subject to 
specific 
exemptions 
under POPs 
Regulation  

33 

 
 
 
 
 
Implementing 
Act 
Commission 
Implementing 
Decision of 11 
February 
2016 

Chemicals 

Nature  /  status  of 
decision  

Methamidophos   New 

Final  

Ethylene oxide  

DDT  

decision 
Amending 
previous 
decision 

Amending 
previous 
decision 

Import 
decision 
No consent 
to import 

Interim   Consent to 
import only 
subject to 
specified 
conditions  
No consent 
to import 

Final  

Grounds for 
decision 
Banned  for  use 
under PPPR 
Banned  for  use 
under  PPPR  and 
restricted  under 
BPR  

Banned for use 
under POPs 
Regulation  

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

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

notifications (Article 14) 

Article  14  requires  the  explicit  consent  of  the  importing  country  before  an  export  of 
chemicals  listed  in  Parts  2  or  3  of  Annex  I  can  proceed,  unless  a  positive  import 
response is available in the latest PIC Circular for chemicals listed in Part 3 of Annex I.  

DNAs and the Agency were asked to provide data on explicit consent procedures carried 
out during the reporting period, as well as any difficulties they encountered in doing so. 
Nineteen  Member  States  implemented  the  explicit  consent  procedure  during  the  last 
three years, highlighting some importing countries’ difficulties in handling requests sent 
by Member States as the main challenge. Fewer Member States dealt with Article 14(6) 
and  (7)  provisions,  and  the  information  provided  by  DNAs  suggests  that  few 
implementation  problems  occurred.  Although,  according  to  the  Agency,  it  was  initially 
challenging to interpret the cases to which Article 14(8) provisions applied, the number 
of problem cases has nonetheless been reduced to a very low level.  

4.7.1  Communication  of 

information  and  decisions  to  those 
concerned  within  the  jurisdiction  of  a  Member  State  (Article 
14(3)) 

Article  14(1)  requires  the  Commission  to  forward  PIC  circulars  and  other  relevant 
information  received  from  the  Secretariat  of  the  Convention  to  Member  States,  the 
Agency,  and  industry  associations.  The  Member  States  then  communicate  this 
information  to  those  concerned  in  their  jurisdiction.  All  DNAs  fulfil  this  requirement, 
mainly through emails and the provision of information on their website (Article 14(3)).  

4.7.2  Explicit consent (Article 14(6))18 

During the reporting period, 19 Member States sought explicit consent from the DNA of 
the  importing  country,  under  Article  14(6)(a).  A  total  of  3,362  requests  for  explicit 
consent were handled by DNAs (see Figure 9).  

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

Commission, the DNAs and the consultant. 

34 

 
 
 
 
 
 
 
 
                                                 
Figure 9: Number of requests for explicit consent received by DNAs during the reporting period19  

t
n
e
s
n
o
c

t
i
c
i
l

p
x
e
r
o
f

s
t
s
e
u
q
e
R

10000

1000

100

10

1

DE; 1286 

FR; 559 

BE; 283 

ES; 376 

UK; 238 

SE; 113 

NL; 204 

IT; 142 

PL; 47 

AT; 27 

CZ; 21 

FI; 20 

HU; 20 

IE; 10 

HR; 4 

CY; 3 

DK; 3 

SI; 4 

PT; 2 

Member States 

Of  the  3,362  requests  for  explicit  consent,  56%  were  answered.  The  share  decreased 
over  the  reporting  period  (61%  in  2014,  58%  in  2015,  and  51%  in  2016).  This 
explained  why  the  Agency  had  to  send  a  significant  number  of  reminders.  A  first 
reminder  was  sent  for  65%  of  the  requests,  and  a  second  reminder  for  42%  of  the 
requests (see Table 15).  

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

2014 
2015 
2016 
Total  

First reminder  
469 
826 
899 
2,194 

Second reminder  
235 
627 
563 
1,425 

During the reporting period, there were four instances in France and Germany where for 
chemicals  listed  in  Part  3  of  Annex  I,  explicit  consent  from  the  DNA  of  the  importing 
country  was  provided  by  the  latest  circular  issued  by  the  Secretariat  of  the  Rotterdam 
Convention, according to Article 14(6)(b) (see Table 16). 

Table 16: Number of requests for explicit consent pursuant to Article 14(6)(b)  

Member State 
France 
Germany 

2014 
0 
0 

2015 
0 
0 

2016 
1 
1 

Total  
1 
1 

19 For 2014, the period covered is 1 March-31 December (as the PIC Regulation became applicable on 1 March 

2014).  

35 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
 
 
 
Difficulties  encountered 
procedure  

in  the 

implementation  of  the  explicit  consent 

Eight  Member  States  reported  having  experienced  difficulties  in  implementing  the 
explicit  consent  procedure.  According  to  most  DNAs,  the  main  challenge  was  late 
responses  from  importing  countries  to  consent  requests  (i.e.  after  the  60-day  waiting 
period) or no response at all. The DNAs also stated that the response provided was not 
always clear or was difficult to interpret, that certain countries were particularly difficult 
to  reach  (e.g.  where  the  request  had  to  be  sent  by  regular  mail),  and  that  certain 
countries imposed additional national rules that caused further delays.  

The  Agency’s  involvement  in  the  explicit  consent  procedure  consists  of  verifying  the 
metadata  associated  with  explicit  consent  requests  after  it  is  uploaded  to  ePIC  by  the 
DNA (and before it can be used for processing purposes). According to the Agency, this 
process  has  worked  smoothly  in  recent  years  and  has  contributed  to  harmonised  data 
and the reduction of clerical errors during the procedure.  

The Agency also mentioned that it had agreed a procedure with the Commission and the 
EU  DNAs  for  the  handling  of  requests  for  explicit  consent  received  from  a  non-EU 
country, as the PIC Regulation does not provide any such procedure. This procedure, it 
stated, could be reflected in the legal text.  

4.7.3  Waivers (Article 14(6) and (7)) 

Explicit  consent  in  case  of  exports  of  chemicals  listed  in  Part  2  of  Annex  I  to 
OECD countries  

According to Article 14(6), when a chemical qualifying for PIC notification is exported to 
an OECD country, the DNA can waive the requirement for explicit consent on a case-by-
case  basis,  at  the  request  of  the  exporter  and  after  consulting  the  Commission.  Six 
Member States were requested to decide whether or not explicit consent was required in 
the case of export of chemicals listed in Part 2 of Annex I to OECD countries (see Table 
17). None of the Member States experienced difficulties in taking such a decision. 

Table  17:  Number  of  cases  where  DNAs  were  required  to  decide  whether  or  not  explicit  consent 
was required in case of export of chemicals listed in Part 2 of Annex I to OECD countries  

2014 
Member State 
0 
France 
0 
Germany 
15 
Italy 
0 
Netherlands 
0 
Sweden 
United Kingdom  0 

2015 
8 
2 
19 
1 
2 
1 

2016 
1 
0 
15 
3 
1 
0 

Total  
9 
2 
49 
4 
3 
1 

DNA  decisions  that  export  may  proceed  60  days  after  an  explicit  consent 
request was made  

According to Article 14(7), the DNA of the exporting country can take the decision, on a 
case-by-case basis and in consultation with the Commission, assisted by the Agency, to 
waive  the  explicit  consent  requirement  when  no  reply  from  the  importing  country  has 
been received after 60 days. Such waivers can only be granted if certain conditions are 
met and for a maximum period of 12 months, after which time the exporter will need to 
seek  explicit  consent  again.  Eleven  Member  States  received  waiver  requests  in 
accordance with Article 14(7) during the reporting period (see Table 18). 

36 

 
 
 
 
 
 
 
 
 
 
 
Table 18: Number of waiver requests received per Member State during the reporting period 

2014 
Member State 
11 
Belgium 
0 
Finland 
5 
France 
14 
Germany 
0 
Hungary 
1 
Italy 
2 
Netherlands 
0 
Poland  
1 
Spain 
Sweden 
0 
United Kingdom  1 

2015 
16 
0 
19 
50 
2 
26 
1 
3 
8 
17 
14 

2016 
11 
1 
9 
34 
1 
10 
8 
0 
16 
14 
12 

Total  
38 
1 
33 
98 
3 
37 
11 
3 
25 
31 
27 

Two Member States stated that they experienced difficulties in implementing the waiver 
procedure.  One  DNA  had  difficulties  with  the  languages  in  which  the  documents  were 
submitted and had to request translations, while the second found it difficult to identify 
whether or not the documents provided were valid. 

4.7.4  Validity of explicit consent (Article 14(8)) 

According to the procedure described in Article 14(6), explicit consent, once obtained, is 
valid for three calendar years, after which it must be requested again, unless the terms 
of the consent require otherwise. Export may continue for an additional 12 months after 
the  three-year  period,  however,  pending  a  response  to  a  new  request  for  explicit 
consent. 

Fourteen  Member  States  experienced  cases  where  the  export  was  allowed  to  proceed 
pending  a  reply  to  a  new  request  for  explicit  consent  (see  Table  19).  The  highest 
number was reported by Germany, with 138 cases in total. 

Table  19:  Number  of  cases  where  the  export  was  allowed  to  proceed  pending  a  reply  to  a  new 
request for explicit consent, by Member State, during the reporting period 

2014 
Member State 
0 
Austria 
0 
Belgium 
0 
Cyprus 
0 
Finland 
0 
France 
1 
Germany 
0 
Hungary 
0 
Italy 
0 
Netherlands 
0 
Poland  
0 
Slovenia 
0 
Spain 
0 
Sweden 
United Kingdom  0 

2015 
1 
10 
1 
4 
13 
103 
1 
2 
3 
2 
0 
9 
5 
14 

2016 
1 
1 
0 
6 
5 
34 
2 
2 
11 
0 
1 
17 
7 
18 

Total  
2 
11 
1 
10 
18 
138 
3 
4 
14 
2 
1 
26 
12 
32 

According  to  the  Agency,  Article  14(8)  was  initially  difficult  to  implement  due  to 
misunderstandings in its interpretation and a lack of understanding of the cases to which 
it applied. The issue was then discussed at the 25th DNA meeting (on 21 April 2015) and 
a common approach was identified. Once the way forward had been agreed, the related 
functionality in ePIC was also modified in order to better support the implementation of 

37 

 
 
 
 
 
 
this provision. Since then, although the provision remains challenging to implement, the 
number  of  problem  cases  (i.e.  in  which  the  Agency  and  the  DNAs  disagree  on  the 
interpretation) has been reduced to a very low level.  

4.8  Information on transit movement (Article 16) 

None of the Member States implemented Article 16 during the reporting period. 

4.9  Requirements  linked  to  exported  chemicals  and  accompanying 

information (Article 17) 

Article 17 states that exported chemicals must be packaged and labelled in accordance 
with the provisions on packaging and labelling in the CLP Regulation, the PPPR and the 
BPR. The information on the label must also include the expiry date (for different climate 
zones  if  necessary)  and  the  production  date.  An  SDS  compliant  with  Annex  II  of  the 
REACH  Regulation  must  be  sent  to  each  importer,  together  with  the  chemical.  The 
information on the label and the SDS should be given in the official languages, or in one 
or  more  of  the  principal  languages,  of  the  country  of  destination  or  of  the  area  of 
intended use, insofar as possible.  

The DNAs were asked to provide information on compliance issues observed during the 
reporting  period.  Any  such  issues  chiefly  related  to  packaging  requirements  under  the 
CLP Regulation and the SDS.  

Compliance issues relating to packaging and labelling requirements  
The  national  enforcement  authorities  in  eight  Member  States  experienced  compliance 
issues concerning the information accompanying exported chemicals. Six Member States 
indicated  that  they  had  identified  compliance  issues  relating  to  the  packaging 
requirements of the CLP Regulation (see Figure 10).  

Figure 10: Question 52. Were these compliance issues related to the application of packaging and 
labelling requirements under PPPR, BPR, CLP or other regulations?  

AT, CZ, FR, HU, IT, PT  

CLP

Other

BPR

AT, BG, UK 

AT, CZ, IT 

PPPR

CZ, IT 

0

1

2

3

4

5

6

7

8

Number of Member States 

Compliance issues with the SDS and the language(s) of the label or SDS  
Six Member States reported finding compliance issues relating to the application of SDS 
requirements under the REACH Regulation.  

Other  compliance  issues  concerned  the  obligation  to  give  information  in  one  or  more 
official/principal  languages  of  the  country  of  destination,  both  on  the  label  and  on  the 
SDS (see Figure 11). 

38 

 
 
 
 
 
 
 
 
 
Figure 11: Question 54. Were these compliance issues related to the obligation to give information: 
on the label in one or more official/principal languages of the country of destination or on the SDS 
in one or more official/principal languages of the country of destination? 

On the label in one or more official/principal languages
of the country of destination

AT, CZ, FR, IT, PT, UK  

On the safety data sheets in one or more
official/principal languages of the country of destination

AT, BG, FR, HU, PT 

0

1

2

3

4

5

6

7

8

Number of Member States 

Finally,  two  Member  States  reported  experiencing  compliance  issues  regarding  the 
information and packaging requirements linked to the exported products. Both indicated 
that these compliance issues were related to the expiry date and the storage conditions 
on the label. 

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

According to Article 18 of the PIC Regulation, Member States must designate authorities 
(such  as  customs  authorities)  to  control  the  import  and  export  of  chemicals  listed  in 
Annex  I.  The  Commission,  supported  by  the  Agency,  and  the  Member  States  must 
coordinate  their  enforcement  activities  in  respect  of  the  PIC  Regulation.  The  Forum  for 
Exchange of Information on Enforcement, established by the REACH Regulation, should 
also be used to coordinate the network of authorities responsible for enforcement of the 
PIC Regulation.  

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

Information  provided  by  the  DNAs  shows  that  all  Member  States  have  put  in  place  a 
system  to  ensure  compliance  with  the  PIC  Regulation.  All  Member  States  have 
nominated  authorities  responsible  for  the  enforcement  of  the  PIC  Regulation  (in  most 
Member  States,  this 
is  the  customs  authority  and  the  environmental/health 
inspectorate).  Many  Member  States  have  put  in  place  some  kind  of  enforcement 
strategy (including rules of procedures, written instructions, etc.), and around half have 
established regular training of inspectors. Most Member States have also described their 
applicable  penalty  system.  Twenty  Member  States  reported  having  carried  out  controls 
on  exports  or  imports  during  the  reporting  period,  11  of  which  provided  data  on  the 
results  of  the  controls,  showing  that  few  infringements  were  detected.  Finally,  DNA 
feedback on the Forum activities was positive, with some welcoming the launch of a pilot 
project dedicated to the PIC Regulation.  

4.10.1  National enforcement authorities (NEAs) 

Most Member States have several authorities in charge of enforcing the PIC Regulation. 
Customs are involved in the implementation of the PIC Regulation in all Member States 

39 

 
 
 
 
 
 
 
 
except  Malta  and  the  United  Kingdom.  In  four  countries,  the  customs  administration  is 
the  sole  NEA  (Spain,  Croatia,  Italy  and  Slovakia).  Other  enforcement  authorities  are 
typically  environmental,  chemical  and/or  health  inspection  services.  In  nine  Member 
States, the NEA is part of the same institution as the DNA.  

In almost all of the Member States in which NEAs are involved in the enforcement of the 
PIC Regulation, they are also typically involved in the enforcement of the CLP Regulation 
(27  Member  States),  the  REACH  Regulation  (25  Member  States),  and  the  BPR  (22 
Member States).  

The  majority  of  Member  States  (18)  indicated  that  NEAs  have  sufficient  resources  to 
carry  out  their  obligations  under  the  PIC  Regulation.  Where  Member  States  pointed  to 
insufficient resources in NEAs, they referred specifically to the lack of human resources.  

4.10.2  Training inspectors  

Fifteen  Member  States  indicated  that  inspectors  are  regularly  trained  on  the  PIC 
Regulation. Among the Member States that have organised regular training, eight stated 
that  such  training is included  as  part  of  general  training  on  chemicals legislation,  while 
four mentioned training specific to the PIC Regulation. Nine reported training specifically 
targeting inspectors, while four mentioned training for customs officers. 

Most  Member  States  with  no  regular  training  on  PIC  explained  that  specific/regular 
training was not needed during the reporting period, often because of training provided 
by  the  Agency,  national  guidelines,  and  regular  exchanges  of  information  between  the 
DNAs and the NEAs. Only one Member State reported that training had not taken place 
because of the lack of specialised trainers.  

4.10.3  Enforcement strategy  

Sixteen  Member  States  reported  having  a  strategy  for  the  enforcement  of  the  PIC 
Regulation, of which 14 have already implemented that strategy (see Figure 12). 

Figure 12: Question 62. Does your authority (or any other relevant authority) have an enforcement 
strategy for Regulation (EU) No 649/2012?  

HR, DK, EE, FI, 
FR, EL, LV, LU, 
MT, SI, ES, SE 

AT, BE, BG, CY, 
CZ, DE, HU, IE, 
IT, LT, NL, PL, 
PT, RO, SK, UK 

Yes

No

40 

 
 
 
 
 
 
 
 
 
4.10.4 Enforcement activities  

During  the  reporting  period,  18  Member  States  carried  out  conformity  checks  and  15 
carried out on-site visits in which the PIC Regulation was covered (see Figure 13).  

Figure 13: Enforcement activities carried out in Member States20  

Conformity checks

AT, BE, BG, HR, CY, CZ, EE, FI, FR, DE, HU, IE, LT, NL, PL, PT, RO, SK 

On-site visits

AT, BE, BG,CZ, EE, DE, HU, IE, LT, NL, PL, PT, RO, SI, SE 

Others

DK, DE, EL, IT, LT, MT, NL, UK 

Sampling

AT, EE, DE, IE, IT 

No enforcement activities carried out

LV, LU, ES 

0

2

4

6

8

10

12

14

16

18

20

Number of Member States 

Eight Member States mentioned other enforcement activities (see Table 20):  

  Reactive operations/investigation of issues brought to the DNA’s attention;  
  Controls carried out as part of integral controls on compliance with REACH/CLP; 
  Cooperation with customs;  
  Risk-oriented random checks during custom clearance;  
  Conformity checks to assess whether or not a substance falls within the scope of 

the PIC Regulation;  

  Document checks;  
  Checking reports submitted to the national database.  

In 13 Member States, customs performed controls related to the PIC Regulation during 
the  reporting  period,  representing  the  largest  number  of  controls  in  most  countries. 
NEAs performed controls on exports in 11 Member States. DNAs  reported the following 
data:  

Table 20: Total number of official controls on exports in which the PIC Regulation was covered or 
enforced during the reporting period, by Member State 

Member State 
Austria21 
Belgium22 

Customs 
561 
N/A 

Inspectors  
16 
29 

Others  
N/A 
N/A 

20 Luxembourg and Latvia ticked ‘other’, indicating that no enforcement activities were carried out (as no 

exports took place during the reporting period). 

21 Available data from the inspectors cover only parts of the inspection activities, as export control is not 

separated from general controls; consistent statistics on export-related enforcement activities of NEAs will 
be available from 2017 onwards (implementation of a new Reporting scheme).  

22 Information missing (N/A) as the cooperation agreement between the DNA and the customs is not yet in 

force.  

41 

 
 
 
 
 
 
 
                                                 
 
Member State 
Bulgaria 
Croatia 
Cyprus 
Czech Republic 
Denmark 
Estonia 
Finland23 
France 
Germany24 
Greece 
Hungary 
Ireland 
Italy 
Latvia 
Lithuania 
Luxembourg 
Malta 
Netherlands 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 
United Kingdom 

Customs 
463 
N/A 
3 
N/A 
N/A 
1 
3633 
123 
1 
N/A 
35 
43 
401 
0 
0 
0 
0 
275 
N/A 
135 
0 
0 
0 
0 
N/A 
0 

Inspectors  
0 
0 
1 
N/A 
0 
0 
1 
N/A 
29 
N/A 
30 
N/A 
N/A 
0 
1 
0 
0 
661 
0 
1 
0 
0 
9 
0 
0 
1 

Others  
N/A 
N/A 
0 
N/A 
N/A 
0 
N/A 
N/A 
0 
1725 
N/A 
N/A 
N/A 
0 
0 
0 
4 
0 
N/A 
N/A 
0 
0 
0 
0 
N/A 
0 

In  four  Member  States,  customs  carried  out  controls  on  imports  during  the  reporting 
period.  NEAs  reported  performing  controls  on  imports  in  nine  Member  States.  DNAs 
reported the data contained in Table 21.  

Table 21: Total number of official controls on imports in which the PIC Regulation was covered or 
enforced during the reporting period, by Member State26 

Member State 
Austria 
Belgium 
Bulgaria 
Croatia 
Cyprus27 
Czech Republic 
Denmark 
Estonia 
Finland 

Customs 
0 
N/A 
0 
N/A 
N/A 
N/A 
N/A 
6 
N/A 

Inspectors  
0 
N/A 
40 
0 
0 
N/A 
0 
8 
0 

23 For Year 1, figures from the customs authority cover the whole year 2014 – including the period before the 

entry into force of the new PIC Regulation.  

24 No statistics or records are kept by the customs authorities in Germany.  
25 The category ‘other’ includes conformity checks to assess whether a substance falls within the scope of PIC 

regulation or not.  

26 Member States could report other types of controls in the column ‘other’, although none did.  
27 The DNA indicated that data for customs were not available. 

42 

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

Customs 
N/A 
0 
N/A 
N/A 
43 
804 
0 
0 
0 
0 
0 
N/A 
248 
0 
0 
0 
0 
N/A 
0 

Inspectors  
N/A 
20 
N/A 
63 
N/A 
N/A 
0 
1 
0 
0 
661 
7 
24 
16 
0 
0 
0 
0 
0 

4.10.5  Enforcement actions and penalty systems  

Member  States  were  asked  to  describe  the  measures  that  enforcement  authorities  can 
take to ensure compliance with the PIC Regulation, and their penalty system in case of 
infringement. DNAs typically described a mix of enforcement measures, such as seizure 
and  detention  of  goods,  withdrawal  from  the  market,  suspension  of  activities  etc.  Ten 
Member  States  stated  that  NEAs  could  issue  letters  of  formal  notice  to  request 
compliance  within  a  certain  timeframe.  On  penalties  for  infringements,  23  Member 
States  indicated  that they  impose  fines  for  specific infringements,  often  with  a  scale  of 
fines depending of the gravity of the infringement. In seven Member States, a penalty of 
imprisonment can be imposed on the most serious infringements. 

4.10.6  Infringements during the reporting period  

Infringements found through customs controls  
Three  Member  States  reported  identifying  infringements  through  customs  controls 
(Germany,  France  and  Italy)  (see  Table  22).  The  number  of  infringements  is  very  low 
compared  to  the  number  of  customs  controls  performed28.  Germany  indicated  that  the 
infringement found by customs concerned a chemical that did not conform to the export 
notification.  

Table 22: Number of customs controls and infringements observed during the reporting period  

Member State 
France  
Germany 
Italy 

Controls on exports  Controls on imports 
123 
1 
401 

N/A 
0 
804 

Infringements found 
3 
1 
9 

28 Germany reported one infringement for one control but specified that records of customs controls were not 

kept.  

43 

 
 
 
 
 
 
                                                 
Infringements found through inspectors’ controls  
Nine  Member  States  found  infringements  through  controls  carried  out  by  inspectors 
(Table 23). As there might be overlaps between the numbers of controls performed  on 
exports  and  imports,  it  was  deemed  better  not  to  calculate  shares  of  infringements. 
However, it should be noted that the number of infringements compared to the number 
of  controls  varies  greatly  across  the  nine  Member  States.  One  reason  for  this  variation 
might  be  that  different  types  of  controls  were  performed.  For  example,  the  UK  DNA 
explained that reactive controls were performed, which might explain the low number of 
controls and the high probability of detection of an infringement.  

Table  23:  Numbers  of  controls  carried  out  by  inspectors  and  infringements  observed  during  the 
reporting period  

Member State 
Austria 
Belgium 
Bulgaria 
Finland 
Germany 
Hungary 
Lithuania 
Netherlands 
United Kingdom 

Controls on exports 
16 
29 
0 
1 
29 
30 
129 
66130 
1 

Controls on imports 
0 
N/A 
40 
0 
20 
63 
1 
661 
0 

Infringements found 
8 
10 
7 
1 
21 
2 
1 
2 
1 

The main category of infringement found through inspections was non-conformity of the 
chemical  with  the  export  notification.  Infringements  relating  to  SDS  and  labelling 
requirements were also found (see Table 24).  

Table 24: Types of infringements of the PIC Regulation observed by inspectors during the reporting 
period 

Member State 

Labelling 
requirements 

Safety data 
sheets 

Austria 
Belgium 
Bulgaria 
Finland 
Germany 
Hungary 
Lithuania 
Netherlands 
United Kingdom 

4 
0 
0 
0 
0 
1 
0 
0 
0 

3 
0 
0 
0 
0 
1 
0 
0 
0 

Expiry  date 
of 
the 
chemical 
0 
0 
0 
0 
0 
0 
0 
0 
0 

in 
Chemical  not 
conformity 
with 
export notification 
1 
10 
0 
0 
18 
2 
1 
2 
1 

Other 

0 
N/A 
0 
1 
0 
2 
1 
0 
0 

The  four  infringements  reported  as  ‘other’  concerned:  omitting  to  report  imports 
(Finland);  missing  the  reporting  obligations  under  Article  10  (Hungary)  and  exporting 
without export notification (Lithuania).  

Of the infringements reported in ‘other’, none were through the controls reported in the 
category ‘other’ (i.e. made by neither customs nor inspectors). 

29 Lithuania reported that one exporter was identified as exporting without notification and controlled. Although 

one control is reported for exports and one for imports, it is the same control.  

30 As the Netherlands reported the exact same number of controls by inspectors for exports and imports in 2014, 
2015, and 2016, it can be assumed that both exports and imports were checked during the same controls.  

44 

 
 
 
 
 
 
 
                                                 
Penalties  
Thirteen  infringements  led  to  penalties  in  four  Member  States.  In  Lithuania,  the 
Netherlands  and  Austria,  all  infringements  led  to  penalties,  while  only  a  small 
percentage of infringements (10%) resulted in a penalty in Germany (see Table 25).  

Table 25: Number of infringements that led to penalties during the reporting period  

Member State 
Austria 
Germany  
Lithuania 
Netherlands  

Number of infringements 
8 
2 
1 
2 

4.10.7  Collaboration between DNAs and NEAs  

Collaboration between DNAs and NEAs  

Twenty-three  Member  States  reported  regular  exchanges  of  information  between  the 
DNA(s) and enforcement authorities. Six Member States stated that, as the DNA and the 
NEA are in the same institution, the exchange of information occurs on a daily basis, as 
necessary. Six other Member States indicated that regular meetings were held between 
DNAs  and  NEAs  to  exchange  information,  while  a  further  eight  mentioned  regular 
exchange  of  information  by  email  through  contact  points,  or  following  procedures 
provided  for  in  laws,  agreements  or  guidelines,  or  through  annual  inspection  reports 
sent to the DNA.  

Few Member States described the types of information exchanged: cases of exports and 
imports  and  exporting/importing  companies  (four  Member  States),  interpretation  and 
scope  of  the  PIC  Regulation  (two  Member  States),  updates  and  changes  in  the  PIC 
Regulation (one Member State).  

Eleven  Member  States  made  suggestions  to  improve  collaboration  between  the  DNAs 
and  enforcement  authorities.  Some  also  mentioned  the  following  exchanges  of 
information between authorities at national level:  

  Enhance  information  exchange  /  updates  between  the  DNA  and  enforcement 

authorities, including customs; 

  Organise face-to-face meeting at least once a month; 
  Organise training courses on PIC issues for all enforcement authorities;  
  Keep  information  available  on  DNA  and  NEA  websites  up  to  date  with  legal 

changes.  

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

  Exchange  of  best  practices  between  Member  States  with  a  lot  of  experience  in 
PIC  controls  and  those  with  quite  limited  numbers  of  exports  subject  to  PIC 
Regulation provisions;  

Improve cooperation and coordination by DG ENV with DG TAXUD;  

  Make the PIC procedure more visible in the Forum;  
 
  Fully  implement  the  Single  Window  System,  to  control  all  customs  declarations 
that  have  indicated  a  RIN  code,  not  only  the  customs  declaration  physically  or 
controlled by documentation;  

  Ensure  specific  CN  codes  are  used,  as  these  are  easier  to  control  than  products 

with generic CN codes.  

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

Twenty-three  Member  States  reported  regular  exchange  of  information  between  the 
DNAs and the national member(s) of the Forum. 

45 

 
 
 
 
 
 
 
Of  those  Member  States  reporting  close  collaboration,  seven  explained  that  regular 
exchanges  of  information  occur  without  formal  communication  or  coordination 
mechanisms, as the Forum member is also a member of the DNA or is part of the same 
institution31.  Other  Member  States  indicated  regular  exchange  of  information,  either 
through  written/electronic  communication  channels  or  through  regular  meetings 
between  institutions  on  outcomes  of  DNA  and  Forum  meetings  and  activities  of  the 
Forum related to PIC (e.g. pilot projects, guidance development). 
Nearly all Member States (26) indicated their satisfaction with the collaboration with the 
national Forum members. 

Five Member States provided suggestions for improving collaboration between DNAs and 
Forum members:  

 

Inform  DNAs  about  any  Forum  activities  concerning  the  PIC  Regulation,  provide 
DNAs  with  direct  access  to  Forum  documents,  or  give  DNAs  the  option  to 
participate in Forum meetings;  

  The  Forum  Secretariat  at  the  Agency,  which  also  reports  to  the  DNA  meetings, 
should inform Forum members in advance, so that they can contact their DNA(s) 
about issues in enforcement; 
Invite Forum members involved in PIC activities to attend PIC DNA meetings;  
Increase communication between DNAs and Forum members.  

 
 

One  DNA  added  that  the  planned  PIC  pilot  enforcement  project  presents  a  good 
opportunity  to  enhance  collaboration  between  DNAs,  Forum  members,  NEAs  and 
customs.  

4.10.8  Forum activities  

The Forum did not engage in any regular exchange of information on the PIC Regulation 
during the reporting period, but such exchange is part of the Forum’s Multiannual Work 
Programme.  In  2016,  the  Forum  decided  to  run  a  pilot  project  on  PIC  enforcement, 
focusing on  export notifications. The preparation and execution of this project  will take 
place in the next reporting period. The Forum has also defined the specifications for the 
PIC form in the ICSMS tool (Commission-owned IT platform for exchange of information 
in a secure way between NEAs). 

Although  Forum  activities  on  PIC  are  just  beginning,  19  Member  States  indicated  their 
satisfaction with the activities carried out by the Forum.  

Eight Member States suggested improvements to the activities of the Forum in respect 
of the PIC Regulation:  

  Five  Member  States  pointed  to  the  need  to  carry  out  enforcement  projects  or 

pilot projects related to the PIC Regulation; 

  One  Member  State  suggested  adding  the  PIC  Regulation  to  the  general  controls 

on REACH, CLP, POPs, mercury;  

  One  Member  State  underlined  the  importance  of  keeping  the  PIC  best  practice 

document up-to-date;  

  One  DNA  suggested  increasing  the  possibilities  for  sharing  experiences  between 

Member States;  

  One  Member  State  suggested  that  DNA  experts  should  be  invited  to  Forum 

meetings for discussions on activities relating to PIC Regulation.   

According  to  the  Agency,  careful  prioritisation  of  PIC  activities  is  essential,  given  the 
limited  resources  of  the  Forum,  and  the  many  priority  areas  for  coordinated 

31 One Member State provided the same justification for replying ‘no’.  

46 

 
 
 
 
 
 
 
                                                 
enforcement.  One  potential  improvement  would  be  to  increase  the  number  of  PIC-
related  activities,  including  integration  into  enforcement  projects  relating  to  other 
legislation. 

4.11 Exchange of information (Article 20) 

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

Information provided following ad-hoc requests  

The  Commission  provided  an  answer  to  two  requests  from  third  countries  in  2014-
201532:  

  One  from  Peru,  asking  whether  or  not  three  particular  mixtures  were  subject  to 

an export notification under the EU PIC Regulation. 

  One  from  Serbia,  requesting  clarifications  of  the  provisions  on  mercury  with 
respect to Regulation (EU) No 649/2012 and Regulation (EC) No 1102/2008. 

The  Commission  replied  to  four  requests  in  2016  from  four  countries  (Canada, 
Indonesia,  Lebanon  and  Syrian  Arab  Republic)  concerning  four  chemicals.  In  addition, 
information was sent to Ecuador in response to a request. 

The Agency did not receive any requests within the scope of Article 20 in either 2014 or 
2015. It received two requests in 2016, from the authorities in the Syrian Arab Republic 
and China, respectively.  

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

Reporting on the information transmitted 

The  Agency  published  its  first  compilation  of  transmitted  information  in  November 
201633,  covering  the  first  two  years  of  implementation  of  the  PIC  Regulation  (2014-
2015).  The  report  addresses  information  submitted  by  means  of  export  notifications, 
FRA  notifications,  and  following  ad-hoc  requests.  The  next  Article  20  report  will  cover 
the 2016-2017 period.  

The  Agency  did  not  experience  difficulties  in  collecting  the  information  from  the 
Commission  and  the  Member  States  on  the  data  transmitted.  The  only  challenge  it 
reported  was  in  clarifying  the  scope  of  the  report  with  the  Commission  and  Member 
States, as it was the first of its kind. The scope of the report was clarified between the 
Commission and the Agency and discussed with the DNAs at the 27th DNA Meeting (held 
on 26 April 2016). The Agency shared the lessons learned from this reporting exercise at 
the 28th DNA meeting (14 December 2016) in order to achieve more clarity for the next 
reporting period. 

32 ECHA, Overview on the exchange of information under Article 20 of the PIC Regulation - Compilation of the 
information collected by the European Commission, assisted by the Member States and the European 
Chemicals Agency (ECHA), 2016, available at: 
https://echa.europa.eu/documents/10162/21728206/pic_article_20_report_2014-2015_en.pdf/ad0e2b0d-
4f12-486f-b1da-9fd2ddbbb187 

33 Idem. 

47 

 
 
 
 
 
 
 
 
 
 
                                                 
4.12 Technical assistance (Article 21) 

Under  Article  21,  the  Commission,  DNAs  and  the  Agency  must  cooperate  in  promoting 
technical  assistance,  in  particular  to  help  developing  countries  and  countries  with 
economies in transition to implement the Convention and to develop the infrastructure, 
capacity  and  expertise  necessary  to  manage  chemicals  properly  throughout  their 
lifecycles.  In  addition,  the  Commission  and  DNAs  must  actively  participate  in 
international  activities  in  capacity-building  in  chemicals  management,  and  consider 
giving support to NGOs.  
The  Agency  and  DNAs  were  asked  to  describe  the  activities  in  which they  participated. 
The Agency mainly participated in activities intended to explain the specific provisions of 
the  PIC  Regulation  and  the  differences  with  the  provisions  of  the  Convention.  DNA 
activities,  by  contrast,  consisted  of  the  provision  of  technical  expertise  or  technical 
information through training workshops, visits, twinning projects, etc.  

Cooperation  with  developing  countries,  countries  with  economies  in  transition 
and NGOs  

During  the  reporting  period,  the  Agency  was  involved  in  the  following  cooperation 
activities:  

  2015 workshop organised by the Rotterdam Convention Secretariat to strengthen 
cooperation  on  the  implementation  of  the  Convention  between  the  DNAs  of 
Burundi, Cameroon, Congo, Djibouti, Gabon and Rwanda. The aim was to clarify 
the provisions of the Rotterdam Convention and highlight the differences with the 
EU PIC Regulation. 

  2016 workshop organised by the Rotterdam Convention Secretariat to strengthen 
cooperation  on  the  implementation  of  the  Convention  between  the  DNAs  of 
Benin, Burkina Faso, Cabo Verde, Ivory Coast, Gambia, Guinea, Guinea – Bissau, 
Mali, Mauritania, Niger, Senegal, Chad and Togo. Although the Agency cancelled 
its  participation,  it  had  already  contributed  to  preparing  the  training  materials, 
presentations, etc. 

Five  Member  States  participated  in  cooperation  activities,  mostly  relating  to  the 
provision  of  technical  information  and  technical  expertise  in  the  preparation  of  FRA 
notifications to the Secretariat (see Figure 14).  

Figure 14: Question 56. What types of cooperation have you been involved in? 

Technical information

BE, BG, DE, SE 

Technical expertise for the preparation of
notifications to the Secretariat

BE, BG, SI 

Promotion of the exchange of experts

BG, SI, SE 

Other

AT, DE 

Technical expertise for the identification of
hazardous pesticides formulations

Support for the establishment or maintenance of
DNAs

SE 

SE 

0

1

2

3

4

5

Number of Member States 

48 

 
 
 
 
 
 
 
Three DNAs mentioned other types of cooperation:  

  Participation  in  sub-regional  workshops  organised  by  the  Secretariat  of  the 
Convention  (Yaoundé,  16-19  November  2015  and  Dakar,  28  November-1 
December 2016), mentioned above by the Agency (Belgium);  

  Expert  assistance  in  setting  up  the  international  dimension  of  the  Georgian 
Ministry  of  Environment’s  Waste  and  Chemicals  Management  Department  and 
Legal  Department,  in  particular  on  the  development  of  national  legislation  and 
training  staff  on  the  implementation  and  enforcement  of  the  Rotterdam 
Convention  and  the  EU  PIC  Regulation  within  a  twinning  project  on  Waste 
Management in Georgia GE/10/ENP-PCA/EN06, 2012-2014 (Bulgaria); 

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

Capacity-building activities  

The  Agency  organised  or  participated  in  capacity-building  activities  on  the  sound 
management  of  chemicals.  These  targeted  EU  candidate  countries  and  potential 
candidates for EU accession, with a view to supporting them at a technical level to align 
with the REACH, CLP, BRP and PIC Regulations. These activities took place under the EU 
Instrument  for  Pre-accession  assistance  (IPA),  the  European  Neighbourhood  and 
Partnership  Instrument  (ENPI),  the  Technical  Assistance  and  Information  Exchange 
instrument  (TAIEX)  and  twinning  projects.  PIC-related  issues  were  also  put  on  the 
agenda of third country visits to the Agency’s premises.  
The Agency provided some examples of capacity-building activities:  

  2014  workshop  on  PIC  and  ePIC  for  EU  candidate  countries  and  potential 

candidates;  

  3-day  visit  of  a  delegation  from  Turkey  to  the  Agency’s  premises,  to  provide  an 

overview of the Rotterdam Convention and the EU PIC Regulation; 

  Participation in PIC and ePIC training organised by a technical assistance project 

for Turkey; 

  Bilateral  discussions  with  47  non-EU  countries  at  the  margins  of  the  7th 
Conference  of  the  Parties  to  the  Rotterdam  Convention  to  clarify  the  specific 
provisions  of  the  PIC  Regulation,  discuss  problem  cases  and  gather  feedback 
from the authorities in the non-EU countries. 

Six Member States participated in projects or international activities relating to capacity-
building in chemicals management during the reporting period:  

  Twinning project on Waste Management in Georgia (Bulgaria, see above); 
  Activities related to the Minamata Convention and SAICM (France);  
  Visit  of  the  Federal  Institute  for  Operational  Safety  and  Health  in  Dortmund 

(Germany, see above);  

  A TAIEX project in Turkey (Italy);  
  Twinning  Project  (2015–2017)  on  the  Further  Development  of  Chemicals  and 

 

Biocides Products Management in the Republic of Serbia (Slovenia);  
International training courses financed by the Swedish International Development 
Cooperation  Agency,  regional  meetings  and  working  sessions  focussing  on 
capacity-building  and  other  aspects  of  the  sound  management  of  chemicals  in 
Southeast Asian countries, Southern African Development Community countries, 
Brazil, Indonesia, China and Serbia (Sweden).  

4.13 IT-related aspects 

Under  Regulation  (EU)  No  649/2012,  the  Agency  developed  and  continues  to  maintain 
the  IT  tool  ePIC  to  support  the  implementation  of  the  PIC  Regulation,  in  particular  the 
exchange  of  information  between  industry  users,  i.e.  exporters,  and  authorities.  ePIC 
was  launched  in  September  2014,  shortly  after  the  entry  into  force  of  Regulation  (EU) 

49 

 
 
 
 
 
 
No  649/2012  and  replaced  the  previous  EDEXIM  database.  It  consists  of  three 
interfaces,  one  for  industry  users,  one  for  authority  users  (DNAs,  the  Commission,  the 
Agency and enforcement authorities) and one for customs officers.  

For the purposes of this reporting exercise, the Agency was asked to provide information 
on  the  operation  and  use  of  ePIC  and  the  data  made  publicly  available  on  its  website. 
Member  States  were  asked  to  provide  information  on  the  use  of  ePIC  data  at  national 
level and their experiences in using ePIC.  

Overall, the DNAs assessed ePIC as user-friendly and reported no major issues in using 
it. Feedback from industry users to the Agency and DNAs was also generally positive, as 
was  the  feedback  from  customs  and  enforcement  authorities  received  by  DNAs.  The 
Agency  identified  some  improvement  needs  for  ePIC  that  will  be  implemented  in  the 
next  reporting  period,  some  of  which  are  based  on  user  feedback.  All  of  the  data  that 
should  have  been  made  publicly  available  by  the  Agency  according  to  the  Regulation, 
were indeed made available online during the reporting period.  

4.13.1  The ePIC system  

During the reporting period, a total of 2,352 authority and industry users used ePIC (see 
Table 26).  

Table 26: Number of ePIC users during the reporting period34  

Industry  
DNAs  
Commission 
NEAs 

Number of users 
1,836 
127 
1  
388 

As  there  is  no  user  management  for  the  customs  application,  the  Agency  could  only 
provide estimates for the use of the customs interface:  
  26 Member States consulted the application; 
  One Member State checked over 2,500 individual notifications; 
  One Member State checked approximately 600 individual notifications; 
  Five Member States checked between 100-350 individual notifications; 
  Seven Member States checked between 40-100 individual notifications; 
  12 Member States checked fewer than 20 individual notifications. 

The following new features were added to the ePIC system during the reporting period:  
  Management of Article 10 report through ePIC: submission of Article 10 report by 
exporters  and  importers;  checking  of  reports  by  DNAs;  aggregation  of  national 
reports  by  DNAs  and  submission  to  the  Agency;  compilation  of  Member  State 
data by the Agency.  

  Enhanced  explicit  consent  metadata,  with  the  new  ‘RIN  match  algorithm’ 

functionality. 

  Waiver management. 
  Bulk special RIN submissions available to industry. 
  Automated sending of all email communication for export notifications, including 
cover notes, second sending of export notifications after 30 days (in the absence 
of an acknowledgement of receipt) and explicit consent reminders.  

  Pre-filled explicit consent request forms for DNAs. 
  Possibility for the Agency users to add/edit PIC chemicals.  

34 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.  

50 

 
 
 
 
 
 
 
 
                                                 
 

Implementation  of  fully-fledged  workflows  with  associated  task  items  and 
deadlines. 

  Event  history,  submission  history  and  message  history  available,  allowing 

traceability for audit purposes and for everyday follow-up of tasks/actions. 

  Message box embedded in task items.  
  Enhanced security of the application.  

According  to  the  Agency,  these  new  features  reduced  processing  time,  increased 
efficiency, enabled traceability and contributed to ensuring consistency and reliability of 
the  data  in  the  system.  They  also  enabled  all  stakeholders  (industry,  DNAs,  the 
Commission and the Agency itself) to manage an increasing number of tasks and meet 
legal deadlines without significantly increasing their staff numbers.  

4.13.2  User-friendliness of the ePIC system  

DNAs  
According  to  the  Agency,  the  feedback  received  from  the  DNAs  was  generally  positive. 
Many  of  their  suggestions  for  improvement  were  implemented  during  the  reporting 
period.  

In their reporting questionnaires, the DNAs were also generally positive about the user-
friendliness of ePIC in carrying out their main obligations under the PIC Regulation. The 
only area where several Member States reported difficulties was the Article 10 reporting 
(see Figure 15).  

Figure 15: Question 79. Is the ePIC system easy to use for DNAs?  

When dealing with export notifications (Article 8)

When dealing with requests for explicit consent
(Article 14)

When dealing with special RIN requests (Article
19(2))

When dealing with waivers (Article 14 (6) and (7))

When dealing with reporting pursuant to Article 10

When dealing with other PIC procedures

0

5

10

15

20

25

30

Number of Member States  

Yes

No

No experience

Exporters and importers  

Similarly,  the  Agency  received  generally  positive  feedback  from  industry  users,  with 
stakeholder  surveys  indicating  that  87%  of  industry  users  in  2015  and  96.7%  in  2016 
were  satisfied  with  ePIC.  The  simplicity  of  the  application  and  the  pre-filled  data  were 
reported as being particularly valuable.  

The  feedback  received  by  DNAs  from  industry  users  was  also  generally  positive, 
although  it  should  be  noted  that  only  around  half  of  the  Member  States  replied  to  this 

51 

 
 
 
 
 
 
 
 
 
 
question  (see  Figure  16).  Levels  of  satisfaction  with  ePIC  are  slightly  lower  for  export 
notifications and Article 10 reporting. 

Figure  16:  Question  80.  Where  possible,  please  provide  feedback  from  exporters  on  the  user-
friendliness of the ePIC system.  

General user-friendliness

Export notifications

Special RIN requests

Waivers

Article 10 Reporting

Management of mixtures/articles via ePIC

0

5

10

15

20

25

30

Number of Member States 

Easy to use

Not easy to use

No Answer

One  DNA  mentioned  that  companies  judged  the  ePIC  User  Manual  too  lengthy  and 
detailed,  and  suggested  that  it  would  be  useful  to  create  user-friendly  factsheets,  or 
short  guidance,  such  as  those  that  exist  for  REACH.  Another  DNA  recommended  that 
guidance and tools should be provided in national languages.  

One  DNA  stated  that  exporters  would  find  the  export  notification  process  more  user-
friendly if they could communicate directly with the Agency to understand, for instance, 
why a notification is rejected or pending resubmission. It pointed out that the exporter 
does not receive the importing country’s answer in cases where it does not give explicit 
consent  or  rejects  the  export  notification,  creating  problems  for  companies  who  do  not 
know  why  consent  has  not  been  given,  or  how  they  might  amend  their  notification  or 
assist their clients in the importing country with their approach to their own authorities. 
The  same  DNA  also  mentioned  that  exporters  would  find  it  helpful  to  have  the  Active 
RIN Period in the overview.  

On Article 10 reporting, one DNA stated that exporters would find it easier to submit a 
single  report  containing  all  of  the  information  rather  than  having  to  enter  different 
information (amount, country, etc.) separately.  

For enforcement authorities  
19  Member  States  reported  that  their  customs  authorities  used  ePIC,  the  majority  of 
whom  (12)  stated  their  belief  that  customs  found  ePIC  easy  to  use  and  adequate  to 
support their work.  

As  national  enforcement  authorities  other  than  customs  have  only  had  access  to  ePIC 
since  the  second  quarter  of  2016,  the  Agency  has  not  yet  received  any  relevant 
feedback.  Six  Member  States,  however,  indicated  that  their  enforcement  authorities 
used ePIC and considered it easy to use and adequate to support their work.  

52 

 
 
 
 
 
 
 
 
 
 
4.13.3  Areas of improvement  

The Agency identified the following improvement needs for ePIC with a view to reducing 
processing times, reducing the occurrence of clerical errors, increasing compliance with 
legal obligations, and providing for a better user experience overall:  

 
 
 

 

Include the generation of non-confidential Article 10 reports in ePIC; 
Improve the RIN match algorithms; 
Improve  the  management  of  the  chemicals  database  to  make  the  chemicals 
easier  to  search  and  edit,  simplify  the  insertion  of  new  amendments,  make  the 
breakdown  of  group  entries  more  transparent  to  companies,  and  facilitate  data 
dissemination; 
Improve  usability 
improving  data  validation  checks, 
standardising  alerts  and  error  messages,  improving  the  document  upload 
functionality and related options; 

for  exporters  by 

  Further  refine  search  options  to  facilitate  navigation  through  the  increased 

 

volume of data in the system; 
Improve  internal  messaging  to  ensure  that  as  much  communication  as  possible 
can happen within the system, for traceability and audit purposes; 

  Enhance  the  Agency’s  back-office  functionality  to  reduce  the  number  of  manual 

tasks or tasks which require database changes. 

4.13.4  Data dissemination  

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

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

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

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

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

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

14). 

The Agency has a specific webpage dedicated to the PIC Regulation, where the content 
of the legislation and the different procedures are explained. The webpage also contains: 

  A link to the legal text and its amendments35; 
  Article 10 reports on actual quantities of chemicals exported and imported36; 
  Article  20  reports  on  information  exchange,  published  for  the  first  time  in 

November 201637. 

According  to  the  Agency,  the  approach  to  Article  10  reporting,  in  particular  the 
calculation and presentation of data, has been significantly revised compared to previous 
years.  The  new  approach  enables  the  disclosure  of  more  data  while  respecting  the 
Eurostat recommendations on data confidentiality. The data are presented in two levels 
of aggregation, one focused on the exported chemical(s) and the other on the countries 
of export and destination. 

As required by the PIC Regulation, the Agency has also set up a database containing:  

35 PIC legislation: https://echa.europa.eu/regulations/prior-informed-consent/legislation  
36 Annual reporting on PIC exports and imports: https://echa.europa.eu/regulations/prior-informed-

consent/annual-reporting-on-pic-exports-and-imports  

37 Reporting on information exchange: https://echa.europa.eu/regulations/prior-informed-consent-

regulation/reporting-on-information-exchange  

53 

 
 
 
 
 
                                                 
  The list of chemicals subject to the PIC Regulation38; 
  High-level information and statistics on export notifications39; 
  High-level information and statistics on import notifications40; 
  Non-confidential data on explicit consents received from non-EU countries41; 
  EU and non-EU DNA contact details42.  

In  addition,  information  on  substances  subject  to  the  PIC  Regulation  is  also  made 
available through  the Agency’’s webpages ‘Information on chemicals’, which provide an 
infocard for each substance, and, for others, a more detailed profile.  

Feedback received by the Agency on the publicly available data from authorities in non-
EU  countries  was  positive.  In  particular,  those  authorities  found  it  useful  to  have 
summaries  of  export  notifications  and  explicit  consents  for  their  countries.  Feedback 
from companies and trade associations was more mixed. A small number of companies, 
together with one of the main industry trade associations, highlighted that the chemicals 
subject to the PIC Regulation (especially the breakdown of group entries) is not always 
clear  on  the  website  and  could  be  improved.  The  Agency  has  noted  this  request  for 
improvement and will consider it at a later stage.  

38 Chemicals subject to PIC: https://echa.europa.eu/information-on-chemicals/pic/chemicals  
39 Export notifications: https://echa.europa.eu/information-on-chemicals/pic/export-notifications  
40 Import notifications: https://echa.europa.eu/information-on-chemicals/pic/import-notifications  
41 Explicit consents: https://echa.europa.eu/information-on-chemicals/pic/explicit-consents   
42 DNAs: https://echa.europa.eu/information-on-chemicals/pic/designated-national-authority  

54 

 
 
 
 
 
 
                                                 
Annex 

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

55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Contents 

1. 

2. 

INTRODUCTION ................................................................................................... 59 

INTERNAL WORK OF THE COMMISSION .................................................................. 60 

2.1. 

Internal organisation and resources .............................................................. 60 
2.1.1.  Resources ..................................................................................... 60 
2.1.2. 
The Agency’s budget ...................................................................... 60 
2.1.3.  Coordination between the Commission and the Agency....................... 61 
2.1.4.  Coordination between the Commission and DNAs ............................... 61 
2.2.  Policy work ................................................................................................ 61 
Amendments of Annexes I and V to the PIC Regulation ...................... 61 
2.2.1. 
2.2.2.  Union import decisions ................................................................... 63 
2.2.3.  Guidance  to  Member  States  on  the  legal  interpretation  of  the  PIC 

2.3. 

Regulation .................................................................................... 64 
Adoption of a format for reporting on the implementation of PIC ......... 65 
2.2.4. 
Implementation and enforcement of the PIC Regulation .................................. 66 
Emergency situations (Article 8(5)) and waivers (Article 14(7)) ........... 66 
2.3.1. 
Enforcement of the PIC Regulation ................................................... 66 
2.3.2. 

3. 

INTERNATIONAL WORK OF THE COMMISSION ......................................................... 66 

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

COP, the CRC and other subsidiary bodies ..................................................... 67 
3.2.  Communication of information to the Secretariat of the Rotterdam Convention... 68 
3.3.  Financial contribution to the Rotterdam Convention ........................................ 68 
3.4.  Exchange of information (Article 20) ............................................................. 69 

56 

 
 
 
 
 
 
Abbreviations used  

BPR 
CAS 
CoP  
DDT 
DNA 
ECHA   
PIC  
POPs 
PPPR 
REACH 

Biocidal Products Regulation  
Chemical Abstracts Service 
Conference of the Parties to the Rotterdam Convention 
Dichlorodiphenyltrichloroethane  
Designated National Authority  
European Chemicals Agency  
Prior Informed Consent  
Persistent Organic Pollutants  
Plant Protection Products Regulation  
Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
Regulation  

57 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.

  Introduction  

Article 22 of Regulation (EU) No 649/201243 (‘PIC Regulation’) requires the Commission 
to  report  on  its  activities  under  the  Regulation  every  three  years  and  to  compile  a 
synthesis report on the performance of the PIC Regulation, integrating:  

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

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

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

This  reporting  exercise  is  the  first  under  the  new  PIC  Regulation.  It  covers  the  three 
years of implementation since the Regulation entered into force in 2014 (2014-2016). A 
common reporting format for Designated National Authorities (DNAs) was established by 
Commission Implementing Decision (EU) 2016/770 of 14 April 201644, in order to collect 
consistent information across Member States. A reporting format for the Agency’s report 
was  adopted  through  Commission  Implementing  Decision  (EU)  2016/1115  of  7  July 
201645. 

The  present  report  is  the  Commission  report  on  the  performance  of  the  functions  for 
which  it  is  responsible  under  the  PIC  Regulation,  for  the  period  2014-2016.  As  per 
Article  22(2),  it  is  incorporated  in  the  synthesis  report  on  the  operation  of  the 
procedures  during  the period  2014-2016  provided  for  in  Regulation  (EU)  No  649/2012, 
together with the information submitted by the Member States and the Agency.  

In drafting this report, relevant information was compiled from EUR-lex, the website of 
the Rotterdam Convention, and documents published on CIRCABC, including minutes of 
meetings,  and  other  documents  discussed  at  DNA  meetings.  The  sources  used  for  this 
report are listed in Table 1.  

This  report  is  divided  into  two  sections,  the  first  addressing  the  internal  work  of  the 
Commission,  and  the  second  addressing  the  international  work  of  the  Commission,  as 
the  EU  DNA,  coordinator  of  input  provided  by  the  EU  and  its  Member  States,  and 
representative of the EU under the Rotterdam Convention. 

Table 1 : List of relevant documents consulted 

List of relevant documents consulted 
Implementing and delegated acts  

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

Regulation.  

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

43 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.  

44 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.  

45 Commission Implementing Decision (EU) 2016/1115 of 7 July 2016 establishing a format for the submission 
by the European Chemicals Agency of information concerning the operation of the procedures pursuant to 
Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and 
import of hazardous chemicals, C/2016/4141, OJ L 186, 9.7.2016, pp. 13–23.  

58 

 
 
 
 
 
 
                                                 
List of relevant documents consulted 

Regulation.  

  Commission Implementing Decision of 11 February 2016 adopting Union import decisions 

(2016/C 61/06).  

  Commission  Implementing  Decision  of  15  May  2014  adopting  Union  import  decisions 

(2014/C 152/02). 

  Commission Implementing Decision of 14 April 2016 establishing a common format for the 
submission  of  information  concerning  the  operation  of  the  procedures  pursuant  to 
Regulation  (EU)  No  649/2012  of  the  European  Parliament  and  of  the  Council  concerning 
the export and import of hazardous chemicals. 

  Commission  Implementing  Decision  of  7  July  2016  establishing  a  format  for  the 
submission by the European Chemicals Agency of information concerning the operation of 
the procedures pursuant to Regulation (EU) No 649/2012 of the European Parliament and 
of the Council concerning the export and import of hazardous chemicals. 

DNA meeting documents  

  Minutes of 23rd, 24th, 25th, 26th, 27th and 28thDNA meetings.  
  Amendments  to  Annex  I  to  Regulation  (EU)  No  649/2012,  presented  at  23rd,  24th,  25th, 

26th, 27th and 28th DNA meetings. 
Import decisions presented at 23rd, 24th, and 26th DNA meetings. 

 
  Submission of notifications to the PIC Secretariat, presented at 23rd, 24th, 25th, 26th, 27th 

and 28th DNA meetings. 
Implementation issues presented at 23rd, 24th, 25th, 26th, 27th and 28th DNA meetings. 
 
  Documents  on  the  preparation  of  COP  7  and  8,  presented  at  25th,  26th  and  28th  DNA 

meetings. 

Rotterdam Convention’s documents  

 

PIC circulars published by the Rotterdam Convention. 

2.

  Internal work of the Commission  

2.1. Internal organisation and resources  

2.1.1.  Resources  

DG Environment is in charge of the PIC Regulation. Unit B.2 – sustainable chemicals has 
one  policy  coordinator  responsible  for  carrying  out  the  Commission’s  administrative 
functions under PIC. The policy coordinator is supported by a  lawyer for legal questions 
and by a secretary for all organisational work. For international work, Unit B.2 has one 
expert  (the  policy  coordinator)  nominated  to  the  Convention  bodies,  i.e.  the  CRC  and 
the intersessional working group on the process of listing chemicals in Annex III to the 
for  multilateral 
Convention.  In  addition,  colleagues  of  Unit  F.3,  responsible 
environmental  cooperation,  contribute  to  the  international  work,  in  particular  in  the 
context  of  the  Conference  of  the  Parties  (CoP),  by  dealing  with  horizontal  and  cross-
cutting matters, such as financial resources, budget, technical assistance and some legal 
matters.  The  staff  resources  occupied  by  this  work  amount  to  0.4  FTE  for  the  policy 
coordinator and 0.4 FTE for the supporting work, including international matters. 

2.1.2.  The Agency’s budget  

According to Article 24, the budget of the Agency for the operation of the PIC Regulation 
consists of a subsidy granted by the EU for the purposes of this Regulation. The subsidy 
for the period 2014-2016 was set by the Commission as part of its Multiannual Financial 
Framework 2014-2020.  

59 

 
 
 
 
2.1.3.  Coordination between the Commission and the Agency 

The Commission and the Agency cooperate closely in the implementation of Regulation 
(EU)  No  649/2012.  There  are  regular  exchanges  on  scientific,  technical  and  legal 
questions arising in the context of implementation, in particular the legal interpretation 
of provisions and their practical implementation. The Agency participates in all PIC DNA 
meetings  and  reports  on  the  work  done  in  the  area  of  implementation,  including  the 
operation  of  the  IT  application  (ePIC)  and  the  work  of  the  Forum  on  the  Exchange  of 
Information  on  Enforcement.  The  Commission  contributed  to  the  development  of  the 
guidance  produced  by  the  Agency  and  also  to  the  work  of  the  Forum  on  Exchange  of 
Information on Enforcement.  

For  cooperation  with  third  countries  and  the  Secretariat  of  the  Rotterdam  Convention, 
the  Commission  and  the  Agency  closely  coordinate  their  activities  to  ensure  that  the 
most  appropriate  and  effective  assistance  is  provided,  and  that  resources  are  used 
efficiently.  

2.1.4.  Coordination between the Commission and DNAs 

The  Commission  and  the  DNAs  of  the  Member  States  closely  cooperate  in  the 
implementation  of  Regulation  (EU)  No  649/2012.  There  are  regular  exchanges  on 
scientific,  technical  and  legal  questions  arising  in  the  context  of  implementation,  in 
particular through discussions at the twice-yearly PIC DNA meetings. If necessary,  and 
where  appropriate,  the  Commission  consults  DNAs  in  writing  on  specific  questions.  At 
the  same  time,  individual  DNAs  consult  the  Commission  on  specific  questions  of 
interpretation and implementation of the Regulation. 

The  Commission  coordinates  and  consults  with  DNAs  on  any  submissions  to  the 
Secretariat  of  the  Rotterdam  Convention.  On  cooperation  with  third  countries,  the 
Commission  and  DNAs  coordinate  some  of  their  activities  to  ensure  coherence  of  the 
assistance provided and efficient use of resources. 

2.2. Policy work  

2.2.1.  Amendments of Annexes I and V to the PIC Regulation  

Annexes  to  the  PIC  Regulation  are  amended  through  delegated  acts,  adopted  by  the 
Commission, in accordance with Articles 23 and 26 of Regulation (EU) No 649/2012. The 
procedure for adoption of delegated acts requires the Commission to consult experts on 
draft  amendments.  As  the  Commission  explained  in  the  23rd  and  subsequent  DNA 
meetings, this consultation is carried out by presenting the drafts at the DNA meetings 
in  order  to  ensure  that  all  Member  State  experts,  as  well  as  observers,  have  the 
opportunity to comment. Delegated acts are also scrutinised by the European Parliament 
and the Council to ensure that the Commission does not exceed its powers. 

Amendments to Annex I  

Proposed  amendments  to  Parts  1  and  2  of  Annex  I  are  triggered  by  regulatory  actions 
changing  the  legal  status  of  a  substance  under  other  relevant  EU  legislation,  in 
particular: 

  Decision not to approve or to withdraw an active substance under the PPPR.   
  Decision not to approve or to withdraw an active substance under the BPR. 
  Decision to subject  a chemical to authorisation by adding it to the Authorisation 

List (Annex XIV) of the REACH Regulation.  

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

Regulation.  

60 

 
 
 
 
 
 
During  the  reporting  period,  two  Delegated  Regulations  amending  Annex  I  were 
adopted,  in  2014  and  2015  (see  Table  2).  Of  the  substances  added  to  Annex  I,  many 
were  proposed  for  inclusion in  Parts  1  and  2  of  Annex  I  to  the  PIC  Regulation  because 
they  had  been  banned  for  use  as  plant  protection  products  under  Regulation  (EC)  No 
1107/2009, which represented a ban or severe restriction in the use category ‘pesticide’. 
This  was  the  case  for  bitertanol,  cyhexatin,  azocyclotin,  cinidon-ethyl,  cyclanilide, 
ethoxysulfuron,  oxadiargyl,  didecyldimethylammonium  chloride,  and  warfarin  in  2014, 
and  fenbutatin  oxide in  2015.  In  addition,  substances  severely  restricted  as  pesticides, 
such as rotenone and cyfluthrin in 2014, were added to Annex I.  

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

Delegated Act 

Chemical  

Commission 
Delegated 
(EU) 
Regulation 
No  1078/2014  of 
7  August  2014 
amending Annex I 
to Regulation (EU) 
No 649/2012 

Commission 
Delegated 
Regulation 
(EU) 
2015/2229  of  29 
September  2015 
amending Annex I 
to Regulation (EU) 
No 649/2012 

Azocyclotin  
Bitertanol 
Cinidon-ethyl 
Cyclanilide  
Cyfluthrin 
Cyhexatin 
Ethoxysulfuron 
Didecyldimethylammonium 
Chloride 
Oxadiargyl 
Rotenone  
Warfarin 
Azinphos-methyl 
Perfluorooctane sulfonic acid 
Perfluorooctane sulfonates 
Perfluorooctane sulfonamides 
Perfluorooctane sulfonyls 
1,1-Dichloroethene 
1,1,2-Trichloroethane 
1,1,1,2-Tetrachloroethane 
1,1,2,2-Tetrachloroethane 
Dibutyltin compounds 
Dioctyltin compounds 
Fenbutatin oxide 
Lead compounds 
Pentachloroethane 
Trichlorobenzene 
Commercial 
pentabromodiphenyl ether, 
including: tetrabromodiphenyl 
ether, and pentabromodiphenyl 
ether 
Commercial octabromodiphenyl 
ether, including 
hexabromodiphenyl ether and 
heptabromodiphenyl ether 

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

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

Basis for 
inclusion  
PPPR  
PPPR  
PPPR  
PPPR  
PPPR  
PPPR  
PPPR  
PPPR  

PPPR  
PPPR  
PPPR  
Annex III to RC 
Annex III to RC 
Annex III to RC 
Annex III to RC 
Annex III to RC 
REACH 
REACH 
REACH 
REACH 
REACH 
REACH 
PPPR 
REACH 
REACH 
REACH 
Annex III to RC 

Part 3 

Annex III to RC 

Lead  compounds,  dibutyltin  compounds,  dioctyltin  compounds,  trichlorobenzene, 
pentachloroethane, 
1,1,2-
trichloroethane  and  1,1-dichloroethene  were  added  to  Annex  I  in  2015,  as  they  were 
severely restricted as industrial chemicals for public use under the REACH Regulation.  

1,1,1,2-tetrachloroethane, 

1,1,2,2-tetrachloroethane, 

61 

 
 
 
 
 
perfluorooctane 

Amendments  to  Part  3  of  Annex  I  reflect  the  decisions  of  the  CoP  to  include  certain 
chemicals  in  Annex  III  to  the  Convention,  bringing  them  under  the  PIC  procedure. 
sulfonates, 
Azinphos-methyl, 
sulfonic 
perfluorooctane 
commercial 
pentabromodiphenyl  ether  including  tetra-  and  pentabromodiphenyl  ether,  as  well  as 
commercial  octabromodiphenyl  ether  including  hexa-  and  heptabromodiphfaenyl  ether, 
were included in Part 3 of Annex I during the reporting period, following their inclusion 
in Annex III to the Rotterdam Convention.  

perfluorooctane 

perfluorooctane 

sulfonamides 

sulfonyls, 

acid, 

and 

The inclusion of other substances in Annex I was under discussion in 2016, but has not 
yet been formally adopted through a Delegated Regulation. These substances are listed 
in Table 3.  

Table 3 : Chemicals proposed for inclusion in Annex I  

Chemical 
Tepraloxydim 
Carbendazim 
Triflumuron 
Triclosan  
cybutryne 
2,4-dinitrotoluene 
4,4’-
diaminodiphenylmethane 
(MDA) 
5-tert-butyl-2,4,6-trinitro-
m-xylene 
benzyl butyl phthalate 
Diisobutyl phthalate 
Diarsenic  pentaoxide  and 
tris(2-chloroethyl) 
phosphate 
Methamidophos 

Amendments to Annex V  

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

Basis for inclusion  
PPPR 
PPPR 
BPR 
BPR  
BPR 
REACH 
REACH 

Part 1 and 2 

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

Part 1 and 3 

REACH 

REACH 
REACH 
REACH 

Annex 
Convention  

III 

Rotterdam 

At  the  27th  meeting  of  the  DNAs  in  April  2016,  an  amendment  to  Annex  V  was 
discussed, notably the inclusion of hexabromocyclododecane to Part 1 of Annex V to the 
PIC  Regulation.  Hexabromocyclododecane  was  included  in  Part  A  of  Annex  I  to 
Regulation (EC) No 850/2004 (POPs Regulation), following the decision taken under the 
Stockholm  Convention  to  list  this  chemical  in  Part  1  of  Annex  A  to  the  Stockholm 
Convention, and should thus be listed in Annex V to the PIC Regulation.  

2.2.2.  Union import decisions 

As per Article 10 of the Convention, Parties are required to adopt an import decision for 
each  new  chemical  listed  in  Annex  III  and  to  submit  it  to  the  Secretariat  within  nine 
months of receipt of the notification of the listing and the decision guidance document. 
Pursuant to Article 13 of the PIC Regulation, the import decision is adopted by means of 
an  implementing  act,  following  the  advisory  procedure.  The  Commission  drafts  the 
import  decision,  which  is  then  submitted  to  the  REACH  Committee  for  an  opinion,  in 
accordance with the advisory procedure.  

During the reporting period, the Commission adopted two Implementing Decisions (see 
Table  4).  In  2014,  the  Commission  drafted  import  decisions  for  azinphos-methyl, 

62 

 
 
 
 
 
 
 
commercial  pentabromodiphenyl  ether, 
commercial  octabromodiphenyl  ether, 
perfluorooctane  sulfonic  acid,  perfluorooctane  sulfonates,  perfluorooctane  sulfonamides 
and perfluorooctane sulfonyls, which were submitted to the REACH Committee on 7 April 
and  the  Commission  Implementing  Decision  was  adopted  on  15  May.  In  2015,  the 
Commission  drafted  a  new  import  decision  for  methamidophos  and  revised  the  import 
decisions on DDT and ethylene oxide, which were submitted to the REACH Committee in 
late 2015. The Implementing Decision was then adopted on 11 February 2016.  

Table 4 : Union import responses adopted during the reporting period  

Implementing 
Act 
Commission 
Implementing 
Decision of 15 
May 2014 

Chemicals 

Nature / status of 
decision  

Azinphos-methyl   New 

Final  

Commercial 
pentabromodiphe
nyl ether  

decision 
New 
decision 

Final  

Commercial 
octabromodiphen
yl ether  

New 
decision 

Final  

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

Consent to 
import only 
subject to 
specified 
conditions 

New 
decision 

acid, 

Perfluorooctane 
sulfonic 
perfluorooctane 
sulfonates, 
perfluorooctane 
sulfonamides and 
perfluorooctane 
sulfonyls  
Methamidophos   New 

Ethylene oxide  

DDT  

decision 
Amending 
previous 
decision 

Amending 
previous 
decision 

Final  

No consent 
to import 

Final  

No consent 
to import 

Interim   Consent to 
import only 
subject to 
specified 
conditions  
No consent 
to import 

Final  

Commission 
Implementing 
Decision of 11 
February 
2016 

Grounds for 
decision 
Banned for use 
under PPPR 
Banned for use, 
subject to 
specific 
exemptions 
under POPs 
Regulation  
Banned for use, 
subject to 
specific 
exemptions 
under POPs 
Regulation  
Banned for use, 
subject to 
specific 
exemptions 
under POPs 
Regulation  

Banned for use 
under PPPR 
Banned for use 
under PPPR and 
restricted under 
BPR  

Banned for use 
under POPs 
Regulation  

2.2.3.  Guidance  to  Member  States  on  the  legal  interpretation  of  the 

PIC Regulation 

During  the  reporting  period,  the  Commission,  together  with  the  Agency,  clarified  a 
number  of  implementation  issues  concerning  the  PIC  Regulation,  either  based  on 
implementation  experience  or  requests  from  Member  States.  These  were  discussed  in 
DNA meetings under implementation issues (see Table 5).  

63 

 
 
 
 
 
 
Table 5 : Implementation issues discussed at DNA meetings 

DNA meeting 
23rd DNA meeting (April 2014) 

24th DNA meeting (December 2014) 

25th DNA meeting (April 2015) 

consents 

Implementation issues discussed 
Period  for  application  of  the  waiver  for  export 
to OECD countries 
Exports  of  mercury  containing  measuring 
devices 
Revision of explicit consent form to  adapt it to 
the new PIC terminology 
for 
Explicit 
nonylphenol ethoxylates 
Interpretation and implementation of replies to 
requests for explicit consent 
Interpretation  of  acknowledgement  of  receipt 
of an export notification as an explicit consent  
Use category applied in importing countries  
Interpretation  of  the  second  paragraph  of 
Article 14(8) 
Management of requests for explicit consent by 
India 

nonylphenol 

and 

27th DNA meeting (April 2016) 

26th DNA meeting (December 2015)  Waiver on certain chemicals exported to Brazil  
Explicit consent requests received from Serbia 
Interpretation  of  consent  covering  only  the 
CAS number of paraquat  
Interpretation and implementation of replies to 
requests for explicit consent 

28th DNA meeting (December 2016)  Classification of DDAC when exported  

EU position on language of submitted SDS  
Content of section 6.1 of export notifications 

In  2015,  the  Commission  also  provided  guidance  on  the  implementation  of  the 
Regulation  by  drafting  a  PIC  customs  factsheet  providing  information  on  the  PIC 
Regulation  to  customs.  Member  States  were  asked  to  distribute  the  factsheet  to  the 
relevant authorities.  

2.2.4.  Adoption  of  a  format  for  reporting  on  the  implementation  of 

PIC  

Every three years, Member States and the Agency are required to submit information on 
the operation of the PIC Regulation’s procedures (Article 22(1)). According to Article 22, 
the Commission was to adopt a common format for reporting through an implementing 
act.  Two  implementing  acts,  one  laying  down  the  common  format  for  reporting  for 
Member States (Decision 2016/770) and the other for the Agency (Decision 2016/1115) 
were adopted, in April and July 2016, respectively, after a long consultation process with 
Member States and the Agency (see Table 6). 

Table 6 : Implementing acts adopted during the reporting period 

Decision 
Commission 
Implementing 
Decision 
2016/770 
Commission 
Implementing 
Decision 
2016/1115  

(EU) 

(EU) 

Title  
Common  format  for  the  submission  of  information 
concerning the operation of the procedures pursuant 
to Regulation (EU) No 649/2012 

Date 
April 2016 

for 

the  submission  by 

the  European 
Format 
Chemicals  Agency  of  information  concerning  the 
operation  of  the  procedures  pursuant  to  Regulation 
(EU) No 649/2012 

July 2016 

64 

 
 
 
 
 
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 
(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.  

the  notification  procedure 

According to Article 14(7), a DNA can decide that an export of chemicals listed in Part 2 
or  3  of  Annex  I  can  proceed  if  no  response  to  a  request  for  explicit  consent  has  been 
received within 60 days, or if no evidence from official sources of final regulatory action 
(FRA)  to  ban  or  severely  restrict  the  use  of  the  chemical  has  been  taken  by  the 
importing  Party  or  another  country.  The  DNA  must  consult  the  Commission  in  making 
this decision.  

In  both  cases,  the  procedures  worked  smoothly  during  the  reporting  period,  and  the 
Commission was positive about its coordination with the DNAs.  

2.3.2.  Enforcement of the PIC Regulation  

The Commission cooperates with the Forum for Exchange of Information on Enforcement 
with  respect  to  enforcing  the  PIC  Regulation.  During  the  reporting  period,  the  Forum 
gave  a  mandate  to  the  Working  Group  Electronic  Information  Exchange  System  (EIES) 
to  analyse  the  requirements  for  a  system  for  exchange  of  information  on  PIC 
enforcement. The Working Group recommended using ICSMS, the Commission-owned IT 
platform for exchange of information between National Enforcement Authorities (NEAs), 
once it has been adapted to the needs of PIC enforcement authorities. The Commission 
informed  the  Member  States  at  the  28th  DNA  meeting  in  December  2016  that  these 
changes would be implemented into ICSMS in the first half of 2017.  

In  2015,  the  Commission  also  drafted  a  PIC  customs  factsheet,  providing  customs 
authorities in the Member States with appropriate information on the PIC Regulation, in 
particular the obligations of relevant stakeholders and their enforcement. 

3.

  International work of the Commission  

The  international  work  of  the  Commission  covers  its  participation  in  Rotterdam 
Convention  activities  and  all  exchanges  with  the  Secretariat  of  the  Convention.  The 
Commission  acts  as  the  common  designated  authority  of  the  EU  for  the  administrative 
functions of the Convention with reference to the PIC procedure (Article 5(2)). As the EU 
DNA, the Commission is responsible for:  

  Representation of the EU to the Rotterdam Convention.  
  Coordination  of  EU  input  on  all  technical  issues  related  to  the  Convention,  the 
preparation  of  the  CoP,  the  Chemical  Review  Committee  (CRC),  and  other 
subsidiary bodies of the CoP.   

  Submission to the Secretariat of relevant FRA notifications concerning chemicals 

qualifying for PIC notification.  

  Transmission  of  information  concerning  other  FRA  involving  chemicals  not 

qualifying for PIC notification.  

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

the PIC procedure.  

  Exchange of information with the Secretariat in general.  

65 

 
 
 
 
 
 
3.1. Preparation,  coordination  and  submission  of  EU  input  to  the 
Secretariat, the COP, the CRC and other subsidiary bodies  

Representation  of  the  Union  to  the  Rotterdam  Convention  and  coordination  of 
EU input  

  7th Conference of the Parties to the Rotterdam Convention 

During the reporting period, the Commission represented the EU at the 7th Conference of 
the Parties to the Rotterdam Convention, which took place  from 4-15 May 2015, back-
to-back  with  the  12th  CoP  to  the  Basel  Convention  and  the  7th  CoP  to  the  Stockholm 
Convention. 
Before CoP 7, the Commission prepared and consulted with the Member States (as it did 
for previous CoPs) on the position of the EU on matters discussed at the meeting, which 
consisted of:  

  A proposal for a Council Decision establishing the EU position on amendments to 
Annex III to the Convention, to get the mandate for decision-making at the CoP. 
This document was then discussed at the Council Working Party on International 
Environmental  Issues  and  at  the  Council  Working  Party  on  Environment,  and 
adopted by the Council on 6 March 2015.  

  A position paper, discussed with the Member States at the Council Working Party 
on  International  Environmental  Issues’  meetings,  presenting  the  position  to  be 
taken on the various items that would be discussed at the CoP. The final version 
of this position paper was agreed in April 2015. 

  A  position  paper  on  budget  and  management  issues,  covering  the  Rotterdam, 
Basel  and  Stockholm  Conventions,  as  the  Programmes  of  Work  and  budgets  of 
the three Conventions were addressed in a joint session.  

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

Rotterdam, Basel and Stockholm Conventions.  

All  position  papers  were  accompanied  by  a  document  outlining  the  statements  to  be 
delivered on behalf of the EU or the EU and its Member States in plenary sessions of the 
COP.  Those  documents  were  also  drafted  by  the  Commission,  in  consultation  with  the 
Member States. 

After  CoP  7,  the  Commission  presented  the  outcomes  of  the  CoP  to  DNAs  at  the  26 th 
DNA  meeting  on  21  October  2015.  The  Commission  also  submitted,  together  with  the 
Presidency, an information note on the outcomes of the CoP to the Rotterdam, Basel and 
Stockholm  Convention,  transmitted  by  the  General  Secretariat  of  the  Council  to  the 
delegations  on  10  June  2015.  In  addition,  all  of  the  statements  made  on  behalf  of  the 
EU  or  on  behalf  of  the  EU  and  its  Member  States  during  the  CoP  were  published, 
together with the statements made at the 12th CoP to the Basel Convention and the 7th 
CoP  to  the  Stockholm  Convention,  through  an  information  note  of  the  General 
Secretariat of the Council to delegations on 6 July 2015.  

  8th Conference of Parties to the Rotterdam Convention 

During the reporting period, the Commission started preparing the proposal for a Council 
Decision on the amendments of Annex III to the Convention and the position of the EU 
and its Member States on matters that would be discussed at the next CoP, scheduled to 
take place from 24 April- 5 May 2017.  

Participation in committees and expert groups  

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

  The  CRC,  where  a  Commission  official  was  nominated  by  Spain  and  acted  as 
Chair of the three meetings of the CRC that occurred during the reporting period: 
the  10th  Meeting  of  the  CRC  in  October  2014,  the  11th  meeting in  October  2015 
and the 12th meeting in September 2016.  

66 

 
 
 
 
 
 
  The intersessional working group on the process of listing chemicals in Annex III 

to the Convention, where one official represented the Commission.  

The Commission on the CRC meetings and the work of the intersessional working group 
of the Convention at the subsequent DNA meetings.  

3.2. Communication  of  information  to  the  Secretariat  of  the 

Rotterdam Convention  

Notification of FRA  

As  per  Article  11  of  the  PIC  Regulation,  the  Commission  must  notify  the  Secretariat  of 
the Rotterdam Convention, in writing, of the chemicals listed in Part 2 of Annex I which 
qualify for PIC notification. The Commission drafts the notifications, which are submitted 
to DNAs and observers for comments before being submitted to the Secretariat.  

Three notifications were submitted to the Secretariat during the reporting period:  

  Chemicals  notified  after  inclusion  in  Annex  I  by  Commission  Regulation 

(EC) No 73/2013 (2014)  

o  Naled 

  Chemicals  notified  after  inclusion  in  Annex  I  by  Commission  Delegated 

Regulation (EU) No 1078/2014 (October 2016)  

o  Bitertanol  

  Chemicals  notified  after  inclusion  in  Annex  I  by  Commission  Delegated 

Regulation (EU) No 2015/2229 (October 2016)  

o 

Fenbutatin oxide 

Communication of Union import responses 

In line with Article 10 of the Rotterdam Convention and Article 13 of the PIC Regulation, 
the Commission communicated the formally adopted import decisions to the Secretariat 
of  the  Rotterdam  Convention.  The  import  decisions  were  published  on  the  Convention 
website in December 2014 and June 2017.  

Ad-hoc Secretariat requests  

The  Commission  replied  to  a  number  of  information  requests  from  the  Rotterdam 
Convention  Secretariat,  e.g.  on  the  definition  of  pesticides,  or  information  on  exports, 
export notifications and information exchange.  

Following  the  6th  CoP,  the  Secretariat  of  the  Convention  asked  that  Parties  complete 
questionnaires on the exchange of information on exports between Parties, and whether 
export  notifications  are  being  submitted  by  exporting  Parties  and  acknowledged  by 
importing  Parties.  The  Commission,  as  the  EU  DNA,  prepared  the  answer  to  the 
questionnaire on behalf of the EU and its Member States.  

3.3. Financial contribution to the Rotterdam Convention  

As  a  Party  to  the  Rotterdam  Convention,  the  EU  contributes  to  the  Convention’s  Trust 
Fund  and  Special  Voluntary  Trust  Fund  for  the  implementation  of  the  programme  of 
work for technical assistance (see Table 7).  

On its contribution to the Special Voluntary Trust Fund, the Commission works with the 
Secretariat of the Convention to specify the content of the projects to be carried out in 
cooperation  with  the  beneficiary  Parties.  Those  projects  aim  to  assist  Parties  that  are 
developing  countries  or  countries  with  economies  in  transition, in  order  to  improve  the 
implementation of the Convention. 

67 

 
 
 
 
 
 
 
 
 
Table 7 : Financial contributions from the EU to the Rotterdam Convention’s Trust Fund and Special 
Voluntary Trust Fund (EUR)46 

Year 

2014 
2015 
2016 

EU Contribution to Trust Fund 

51,195 
55,474 
54,582 

EU  Contribution  to  Special  Voluntary 
Trust Fund 
277,331 
302,815 
513,603 

3.4. Exchange of information (Article 20) 

According  to  Article  20,  the  Commission,  assisted  by  the  Agency  and  the  Member 
States,  must  facilitate  the  provision  of  scientific,  technical,  economic  and  legal 
information  to  other  countries  about  chemicals  subject  to  the  PIC  Regulation, including 
toxicological, ecotoxicological and safety information.  
The Commission provided an answer to two requests in the period 2014-201547:  

  One  from  Peru,  asking  whether  three  mixtures  were  subject  to  an  export 

notification under the EU PIC Regulation. 

  One from Serbia, requesting clarification of provisions on mercury with respect to 

Regulation 649/2012 and Regulation 1102/2008. 

The  Commission  replied  to  four  requests  in  2016  from  four  countries  (Canada, 
Indonesia,  Lebanon  and  Syrian  Arab  Republic)  concerning  four  chemicals.  In  addition, 
information was sent to Ecuador in response to a request. 

46 From Rotterdam Convention website, amounts converted from USD to EUR at November 2017 rates.  
47 ECHA, Overview on the exchange of information under Article 20 of the PIC Regulation - Compilation of the 
information collected by the European Commission, assisted by the Member States and the European 
Chemicals Agency (ECHA), 2016, available at: 
https://echa.europa.eu/documents/10162/21728206/pic_article_20_report_2014-2015_en.pdf/ad0e2b0d-
4f12-486f-b1da-9fd2ddbbb187 

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