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 COM(2018) 697 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Summary of the Synthesis Report on the operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals  {SWD(2018) 438 final}  
 
 
ABBREVIATIONS USED 

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

RIN 
SDS 

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

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1.  INTRODUCTION  

1.1.  The PIC Regulation  

Regulation  (EU)  No  649/20121  (‘PIC  Regulation’)  implements  the  Rotterdam  Convention 
on  the  Prior  Informed  Consent  (PIC)  Procedure  for  Certain  Hazardous  Chemicals  and 
Pesticides in International Trade, adopted in 1998 and ratified by the Union 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 on the characteristics of 
hazardous  chemicals,  by  providing  for  a  decision-making  process  within  the  Union  on 
their  import  and  export  and  by  disseminating  decisions  to  Parties  and  other  countries 
(Article 1).  

The  PIC  Regulation  applies  to  chemicals  subject  to  the  PIC  procedure  under  the 
Rotterdam Convention and to industrial chemicals (used by professionals and consumers) 
and  pesticides  (including  biocides)  that  are  banned  or  severely  restricted  by  Union 
legislation  for  health  or  environmental  reasons.  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 (CLP) Regulation (EC) No 1272/20082, and to certain articles.  

The PIC Regulation also places obligations on the Commission to notify the Secretariat of 
the Convention of Final Regulatory Action (FRA) that bans or severely restricts the use of 
a  chemical  in  the  Union  in  a  use  category  of  the  Convention  (industrial  chemicals  or 
pesticides). Chemicals for which such notification is required are listed in Part 2 of Annex 
I  of  the  PIC  Regulation.  The  FRA  notification  aims  at  informing  other  Parties  about  the 
potential  risks  from  the  use  of  those  chemicals  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 and based on 
Union  law,  establishes  an  import  decision  that  outlines  whether  and  under  which 
conditions the chemical can be imported in the Union. This, too, is sent to the Secretariat 
of the Convention. 

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

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

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

2 

 
 
 
 
 
 
 
                                                 
1.2.  The reporting exercise  

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

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

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

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

This reporting exercise is the first under this PIC Regulation and 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. A reporting format for the Agency’s report 
was  similarly adopted through Commission Implementing Decision (EU) 2016/1115 of 7 
July 2016 5. 

Member  States  and  the  Agency  were  required  to  report  by  31  May  2017,  but  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, 
upon submission of the final reporting questionnaire.  

The  present  report  is  the  summary  of  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.  

2.  GOVERNANCE OF THE PIC REGULATION 

2.1.  All  Member  States  have  designated  their  national  competent 

authority  

As  per  Article  4  of  the  PIC  Regulation,  Member  States  must  designate  one  or  several 
authorities  (Designated  National  Authorities,  or  DNAs)  to  carry  out  the  administrative 
functions  required  by  the  PIC  Regulation.  DNAs  play  an  important  part  in  the  export 
notification  procedure:  checking  compliance  of  export  notifications  and  forwarding  them 
to the Agency); handling requests for explicit consent and deciding on waivers; handling 
Special  Reference  Identification  Number  (RIN)  requests;  and  informing  the  Commission 

3 Regulation 649/2012 applies 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.  

3 

 
 
 
 
 
 
 
 
                                                 
on  decisions  to  ban  or  severely  restrict  a  chemical  at  national  level.  Under  Article  10, 
DNAs also have  reporting obligations, such as providing the Agency with information on 
trade in chemicals listed in Annex I. They are  also responsible for providing information 
to importing countries on request, facilitating the exchange of information on chemicals, 
and cooperating in the promotion of technical assistance.  

Thirty-five  such  authorities  have  been  designated  by  Member  States.  Most  Member 
States (22) have only one DNA, while six have two or three. DNAs are mostly Ministries 
or  agencies  responsible  for  environment,  chemicals,  and  health  or  health  and  safety. 
Member  States  with  more  than  one  DNA  generally  divide  their  responsibilities,  with  one 
DNA overseeing industrial chemicals, while the other deals with pesticides. 

The  resources  needed  to  implement  the  PIC  Regulation  in  Member  States,  in  particular 
the  human  resources,  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  export  notifications  to  process  and  2  FTE  for  those  Member  States  with  the 
highest numbers of export notifications. 

2.2.  The  Agency’s  workload  has  been  higher  than  expected  before 

the entry into force of the Regulation 

The  Agency  plays  a  central  role  in  ensuring  that  the  export  notification  procedure 
functions properly by:  

  Registering  the  export  notifications,  checking  their  completeness  and  forwarding 

them to the DNA of the importing country (Article 8(2); 

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

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

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)); 

  Supporting  the  EU  DNAs  and  the  Commission  in  assessing  waivers  pursuant  to 

Article 14(6) and 14(7); 

  Collecting, summarising and publishing the data received each year from DNAs on 

the quantities of chemicals exported and imported (Article 10(3)).  

The  Agency  is  responsible  for  developing  and  operating  the  application  for  processing 
export  notifications  and  explicit  consents  given  by  the  importing  countries  (ePIC).  In 
addition,  it  provides  assistance  and  technical  and  scientific  guidance  to  industry,  the 
DNAs from EU Member States and third countries, and the European Commission (Article 
6). 

As  highlighted  in  the  Agency’s  report,  the  number  of  export  notifications  has  increased 
beyond the predicted 10% yearly uplift, generating additional workload beyond what was 
expected, as well as increasing the time spent on supporting DNAs (from EU and non-EU 
countries). Efforts to support EU and non-EU DNAs takes between 30% and 40% of staff 
time.  The  increase  in  export  notifications  also  necessitated  improvements  to  the  PIC 

4 

 
 
 
 
 
 
 
 
application,  e.g.  increasing  the  automation  of  certain  processes  to  reduce  the  workload 
for industry users and authorities and thus assist them to meet legal deadlines.  

Table 1: No. of notifications predicted vs. processed by the Agency  

Estimated no. of notifications 
Actual no. of notifications  

2014 
4,000 
4,575 

2015 
4,300 
5,460 

2016 
6,300 
7,967 

The Agency indicated that the current workload confirms this trend and that undertaking 
this additional work will require additional human and financial resources. 

2.3.  The  Commission, 

the  Agency  and  DNAs  consider 

the 

coordination between EU and national institutions effective  

Member  States  generally  considered  the  coordination  between  DNAs  and  the 
Commission, and between DNAs and the Agency to be satisfactory. Several DNAs valued 
the  support  provided  by  the  Commission  and  the  Agency  for  its  swiftness  and  quality. 
The Agency rates collaboration with DNAs as similarly effective, including when handling 
disagreements.  The  Commission  also  considered  the  cooperation  with  DNAs  to  be 
effective, in particular through discussions at the twice-yearly PIC DNA meetings.  

The Agency considered the collaboration with the Commission satisfactory, pointing to a 
number  of  areas  for  improvement,  such  as  the  preparation  of  notifications  of  FRA,  the 
preparation  of  meetings,  the  implementation  of  Article  14(6)  and  14(7)  and  the 
procedure  for  updating  Annexes.  The  Commission  also  considered  the  cooperation  with 
the Agency to be satisfactory, highlighting the regular exchanges  on scientific, technical 
and  legal  questions  arising  in  the  context  of  implementation,  in  particular  the  legal 
interpretation of provisions and their practical implementation. 

3.  UPDATES OF ANNEX I TO THE PIC REGULATION  

According to Article 23, the list of chemicals in Annex I should be reviewed at least once 
a  year  by  the  Commission,  on  the  basis  of  the  developments  in  EU  law  –  mainly in  the 
REACH Regulation6, the BPR7 and the PPPR8 – and under the Convention. Annexes to the 
PIC Regulation are amended through delegated acts adopted by the Commission. 

During  the  reporting  period,  21  substances  were  included  in  Part  1  and  10  in  Part  2  of 
Annex  I.  Twelve  of  these  substances  were  included  following  a  ban  on  their  use  as 
pesticides under the PPPR, and nine after inclusion in Annex XVII to REACH. Seven were 

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

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

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

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

5 

 
 
 
 
 
 
 
 
 
                                                 
included  in  Part  3  Annex  I  following  their  inclusion  in  Annex  III  to  the  Rotterdam 
Convention.  

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

Delegated Act 

Chemical  

Commission 
Delegated 
(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 1 and 2  
Part 1 and 2 
Part 1 and 2 
Part 1 

Basis for 
inclusion 
PPPR  
PPPR  
PPPR  
PPPR  
PPPR  
PPPR  
PPPR  
PPPR  

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 

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 

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

6 

 
 
 
 
 
 
Table 3: 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 
Commission Delegated Regulation (EU) No 
2015/2229  

Chemicals notified  
Naled 

Date of notification 
April 2014 

Bitertanol 

October 2016 

Fenbutatin oxide 

October 2016 

4.  OPERATION OF THE PIC REGULATION  

4.1.  Awareness-raising  activities  and  support  provided  by  DNAs 
and  the  Agency  to  exporters  have  improved  compliance  with 
the PIC Regulation  

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, 
most  DNAs  provided  support  and  carried  out  awareness-raising  activities  targeting 
national exporters and importers during the reporting period. 

Twenty-five  Member  States  carried  out  awareness-raising  and  information  activities 
targeting  exporters  and  importers  during  the  reporting  period.  Most  created  specific 
webpages  providing  information  on  the  PIC  Regulation  and  references  to  the  Agency 
webpages  on  the  PIC  Regulation  and  ePIC.  Ten  Member  States  also  set  up  a  national 
helpdesk.  Almost  all  Member  States  stated  that  these  activities  improved  compliance 
among exporters and importers with the PIC Regulation. For example, some DNAs noted 
an increase in the number of export notifications received by the DNA, an increase in the 
number  of  companies  registered  in  ePIC,  and  improved  compliance  with  Article  10 
reporting obligations.  

During  the  reporting  period,  the  Agency  published  its  Guidance  for  implementation  of 
Regulation (EU) No 649/2012 concerning the export and import of hazardous  chemicals, 
as  well  as  several  user  manuals  on  ePIC  (for  the  different  user  groups).  It  provided 
information  to  exporters  and  importers  through  its  website,  weekly  e-News  or  the 
Newsletter, and organised a number of workshops on the PIC Regulation, mainly relating 
to the initial development of ePIC. According to the Agency, the increase in the number 
of export notifications sent by EU exporters and the number of companies implementing 
the PIC Regulation indicates that awareness of, and compliance with, the Regulation has 
significantly  improved  during  the  reporting  period,  in  part  due  to  its  own  awareness-
raising activities and those of the DNAs.  

4.2.  The  workload  relating  to  the  implementation  of  the  PIC 

Regulation is unevenly distributed between Member States  

The  export  notification  is  the  PIC  Regulation  instrument  by  which  countries  exchange 
information  on  banned  or  severely  restricted  chemicals.  All  EU  based  exporters  must 
submit  an  export  notification  to  their  DNAs  if  they  intend  to  export  chemicals  listed  in 
Part  1  of  Annex  I  to  the  PIC  Regulation  to  a  third  country.  Once  the  DNA  has  checked 
and  accepted  the  notification  (after  resubmission  if  necessary),  it  is  forwarded  to  the 
Agency, which also checks the compliance of the notification and transmits it to the DNA 
of the importing country. If no acknowledgement of receipt is received, the Agency sends 

7 

 
 
 
 
 
 
 
 
 
the  notification  again.  The  whole  procedure  is  carried  out  through  ePIC,  and  exporters 
must use the notification template provided by the system. 

During  the  reporting  period,  Member  States  accepted  and  forwarded  15,771  export 
notifications  to  the  Agency  and  rejected  1,214.  The  number  of  export  notifications 
processed  varied  significantly  between  Member  States.  Three  Member  States  did  not 
process  any  export  notification  during  the  reporting  period  and  five  Member  States  had 
fewer than 10 notifications.  The highest numbers of  export notifications were processed 
by  Germany  (5,196  notifications),  France  (3,358),  the  United  Kingdom  (1,829),  Italy 
(1,321) and Spain (1,265). The importing countries that received the highest numbers of 
export notifications from the Union were Switzerland (1,044 notifications), Turkey (984), 
Russia (890), the USA (754) and China (601). 

For  certain  exports  that  are  exempt  from  the  PIC  Regulation  or  from  the  export 
notification requirement, exporters are required to request a Special RIN from their DNA 
and to use it in the customs declaration to facilitate customs clearance. 

During  the  reporting  period,  17  Member  States  accepted  7,072  Special  RIN  requests, 
which are mainly used for exports that are exempted from the Regulation since they are 
for  research  or  analysis  purposes.  Eleven  Member  States  did  not  deal  with  any  such 
request in the past three years. Germany, the United Kingdom and Belgium accepted the 
highest numbers of these Special RIN requests (see Figure 1).  

Figure  1 :  Total  number  of  export  notifications  and  Special  RIN  requests  accepted  by  DNAs  during 
the reporting period  

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DE; 8317 

FR; 3935 

BE; 1922 

AT; 526 

BG; 107 

DK; 128 

FI; 98 

CZ; 99 

HR; 80 

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NL; 655 

PL; 458 

UK; 2651 

ES; 1820 

SE; 300 

SI; 210 

IE; 59 

HU; 29 

PT; 61 

MT; 8 

RO; 7 

CY; 4 

EE; 1 

EL; 1 

Member States  

4.3.  Exporters  encountered  difficulties  in  completing  the  export 

notification form  

According  to  the  Agency  and  the  DNAs,  exporters  experienced  difficulties  in  providing 
information on the export (e.g. contact details of importers) and the intended use of the 

8 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
chemical  in  the  importing  country.  In  particular,  the  intended  use  and  use  category  for 
exports  of  biocides  was  an  issue  for  exporters.  Twelve  DNAs  also  stated  that  exporters 
had problems with the availability of the Combined Nomenclature (CN) or Customs Union 
and  Statistics  (CUS)  codes.  The  Agency  also  reported  problems  with  section  6.1  of  the 
form, on the summary of and reasons for the FRA and date of entry into force, as some 
exporters introduced inappropriate statements. In addition, several DNAs and the Agency 
all  highlighted  issues  with  the  provision  of  the  Safety  Data  Sheet  (SDS)  in  the  correct 
language,  exports  of  mixtures,  and  entries  of  chemical  groups  in  ePIC,  which  are  not 
necessarily comprehensive, and which created confusion among exporters as to whether 
or not a chemical was subject to the PIC Regulation.  

4.4.  The number of requests for resubmission was relatively high in 

the three-year period  

In a relatively high number of cases, the DNAs or the Agency requested resubmission of 
a  notification.  In  2015-2016,  they  requested  the  resubmission  of  2,503  export 
notifications  altogether,  of  which  566  export  notification  resubmissions  were  requested 
by the Agency (334 in 2015 and 232 in 2016). The main reasons for resubmission related 
to section 6 of the notification form (summary  of, and reasons for, the FRA and date of 
entry into force) and SDS (e.g. language, or SDS not matching the notification). 

4.5.  No  major  delays  were  encountered  in  the  export  notification 

procedure  

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.  The  number  of  notifications  received  by  the  Agency  less  than  25  days 
before the export (which is the deadline specified in the Regulation) accounted for 4.9% 
of the total number of export notifications. In addition, 171 notifications were sent late to 
the  importing  countries  by  the  Agency,  or  1.2%  of  the  total  number  of  notifications 
forwarded to importing countries during the reporting period. Reasons for delays typically 
related  to  difficulties  in  processing  export  notifications  during  the  winter  peak  season, 
companies  failing  to  respect  deadlines  for  resubmissions,  and,  on  the  Agency’s  side, 
delays in receiving notifications from the DNAs.  

4.6.  The  number  of  export  notifications  received  from  non-EU 

countries almost doubled between 2014 and 2016  

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

The  Agency  received  1,105  export  notifications  from  non-EU  countries  in  the  reporting 
period, mainly from the USA and Switzerland. The number of notifications almost doubled 
between 2014 and 2016. 

Table 4: Export notifications received from non-EU countries and acknowledgements of receipt sent 
by the Agency during the reporting period  

Export notifications received  

2014 
209 

2015 
486 

2016 
410 

Total  
1,105 

9 

 
 
 
 
 
 
 
 
 
 
 
4.7.  Reporting under Article 10 worked effectively 

Article  10  places  obligations  on  exporters  and  importers  to  inform  the  DNA,  during  the 
first  quarter  of  each  year,  of  the  quantity  of  chemicals  listed  in  Annex  I  of  the  PIC 
Regulation  exported  to,  or  imported  from,  third  countries  during  the  preceding  year. 
Exporters  must  also  provide  the  DNA  with  the  names  and  addresses  of  each  importer. 
DNAs  must,  in  turn,  provide  this  information  to  the  Agency  annually,  which  then 
aggregates the data at EU level and makes it publicly available on its database9. 

Information  provided  by  the  Agency  and  DNAs  suggested  that  few  problems  were 
encountered  in  the  reporting  process  under  Article  10.  Around  one-third  of  the  DNAs 
stated  that  they  experienced  delays  from  exporters  or  importers  in  the  submission  of 
information, although these delays did not affect the completion of the reporting exercise 
under Article 10. Similarly, the Agency encountered few complications in the compilation 
of Member State information, where DNAs included data on exports of chemicals listed in 
Annex I that were exported for research or analysis purposes and were therefore outside 
the scope of the PIC Regulation and the resulting reporting obligation. 

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,  six  further  specified  that  it  is  used  for  REACH 
enforcement activities (e.g. cross-checking compliance with registration requirements, or 
checking compliance with restrictions).  

4.8.  EU  import  decisions  have  been  adopted  for  seven  substances 

listed in Annex III to the Rotterdam Convention  

As per Article 10 of the Convention, Parties are requested to adopt an import decision for 
each  new  chemical  listed  in  Annex  III  and  to  submit  it  to  the  Secretariat.  Pursuant  to 
Article  13  of  the  PIC  Regulation,  the  Union  import  decision  is  adopted  by  means  of  an 
implementing  act,  which  is  drafted  by  the  Commission  and  submitted  to  the  REACH 
Committee for an opinion, in accordance with the advisory procedure. 

Import  decisions  were  established  through  two  implementing  decisions  adopted  by  the 
Commission in the course of the reporting period.  

Table 5: Union import decisions adopted during the reporting period  

Implementing 
Act 
Commission 
Implementing 
Decision of 15 
May 2014 

Chemicals 

Nature / status of 
decision  

Azinphos-methyl   New 

Final  

Commercial 
pentabromo-
diphenyl ether  

decision 
New 
decision 

Final  

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

Commercial 

New 

Final  

Consent to 

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

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

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

10 

 
 
 
 
 
 
 
 
 
                                                 
Implementing 
Act 

Chemicals 

octabromo-
diphenyl ether  

Nature / status of 
decision  
decision 

Import 
decision 
import only 
subject to 
specified 
conditions 

New 
decision 

Perfluorooctane 
sulfonic acid, 
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 
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  

4.9.  Several third country DNAs experienced difficulties in handling 

explicit consent requests 

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

During  the  reporting  period,  19  Member  States  implemented  the  explicit  consent 
procedure pursuant to  Article 14. They stated that the main challenge was the difficulty 
experienced  by  several  importing  countries  in  handling  explicit  consent  requests,  either 
because the DNAs responded after the 60-day waiting period or did not respond at all. Of 
the 3,362 requests for explicit consent processed by DNAs, 56% received an answer. The 
share  decreased  over  the  reporting  period  (61%  in  2014,  58%  in  2015  and  51%  in 
2016),  while  the  number  increased.  This  explains  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.  

Few  Member  States  had  to  decide  whether  or  not  the  requirement  for  explicit  consent 
should be waived (e.g. six for an export to an OECD country and 11 in the absence of a 
response  from  the  competent  authority  of  the  importing  country),  and  information 
provided  by  DNAs  suggested  that  few  implementation  problems  occurred.  Although  the 
Agency  stated that it was initially challenging to interpret the  cases to which the  Article 
14(8)  provisions  applied,  the  number  of  problem  cases  has  been  reduced  to  a  very  low 
level. 

11 

 
 
 
 
 
 
4.10.  Non-compliance  with 

requirements  on 

accompany  exported  chemicals  was  primarily 
packaging and SDS 

information 

to 
linked  to 

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

National Enforcement Authorities (NEAs) in eight Member States experienced compliance 
issues  in  respect  of  the  information  accompanying  exported  chemicals.  Six  Member 
States  indicated  that  those  compliance  issues  related  to  packaging  requirements  under 
the  CLP  Regulation,  while  a  further  six  indicated  that  they  had  found  compliance  issues 
with the application of SDS requirements under the REACH Regulation.  

4.11.  All  Member  States  have  put  in  place  a  system  for  controlling 
the  export  and  import  of  chemicals  subject  to  the  PIC 
Regulation 

According to Article 18 of the PIC Regulation, Member States must designate authorities, 
such as customs authorities, to control imports and exports of chemicals listed in Annex 
I.  All  Member  States  have  nominated  these  authorities.  Customs  are  involved  in  the 
implementation of the PIC Regulation in all Member States, except Malta and the United 
Kingdom. In four countries, the only national enforcement authority (NEA) is the customs 
administration  (Spain,  Croatia,  Italy  and  Slovakia).  Other  enforcement  authorities  are 
typically  environmental,  chemicals  and/or  health  inspection  services.  In  nine  Member 
States, the NEA is part of the same institution as the DNA. 

In almost all Member States, NEAs involved in the enforcement of the PIC Regulation are 
also  involved  in  the  enforcement  of  other  chemicals  legislation,  such  as  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.  Member  States  who  highlighted 
resource issues within NEAs typically referred to the lack of human resources. 

16 Member States have put in place some kind of enforcement strategy (including rules 
of procedures, written instructions, etc.) and 15 Member States have established regular 
training for inspectors. Most Member States have also described their applicable penalty 
system  for  infringements  of  the  PIC  Regulation.  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  mentioned  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  on  the  gravity  of  the 
infringement. In seven Member States, a penalty of imprisonment can be imposed for the 
most serious infringements.  

12 

 
 
 
 
 
 
 
 
 
 
 
4.12.  Almost  all  Member  States  have  carried  out  enforcement 

activities and identified a high level of conformity 

During  the  reporting  period,  18  Member  States  carried  out  conformity  checks,  while  15 
carried out on-site visits in which the PIC Regulation was covered.  

Figure 2 : Enforcement activities carried out by Member States 

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 

According  to  the  data  provided  by  DNAs,  customs  and  other  NEAs  have  carried  out 
controls  on  exports  of  chemicals  in  17  Member  States,  and  on  imports  of  chemicals 
subject to the PIC Regulation in 11 Member States10. The number of controls performed 
varied greatly between Member States, which could be due to the number of exports and 
imports of PIC chemicals in the country, the inspection strategy, or the types of controls 
performed  (e.g.  reactive  controls  versus  regular  monitoring).  Three  Member  States 
reported  infringements  found  through  customs  controls,  with  a  very  low  number  of 
infringement  cases.  Nine  Member  States  reported  cases  found  through  controls  carried 
out by inspectors, and the level of infringement varied considerably across these Member 
States.  In  some  cases,  this  might  be  linked  to  the  type  of  controls  performed  (e.g. 
reactive  controls  are  more  likely  to  find  infringements).  Thirteen  infringement  cases  led 
to penalties in four Member States. 

Table  6:  Number  of  controls  performed  and  infringements  observed  by  customs  and  inspectors 
during the reporting period11  

Member State 

Controls 
on exports 
and 

Infringements 
found by customs  

Controls on 
exports and 
imports by 

Infringements 
found by 
inspectors  

10  One  DNA  did  not  provide  any  information  on  exports,  six  DNAs  did  not  provide  information  on  customs 
controls on exports. Five DNAs did not provide  any information on imports; eight DNAs did not provide 
information  on  customs  controls  on  imports.  Caution  should  be  exercised  in  comparing  data  between 
Member States as there might be discrepancies in their recording parameters for enforcement activities.  

11 The table only includes those Member States where infringements were found.  

13 

 
 
 
 
 
 
 
 
                                                 
 
Austria 
Belgium 
Bulgaria 
Finland 
France  
Germany 
Hungary 
Italy 
Lithuania 
Netherlands 
United Kingdom 

imports 
by 
customs 
561 
N/A 
463 
3633 
123 
112 
35 
1205 
0 
275 
0 

0 
N/A 
0 
N/A 
3 
1 
0 
9 
0 
0 
0 

inspectors 

16 
29 
40 
1 
N/A 
49 
93 
N/A 
2 
661 
1 

8 
10 
7 
1 
N/A 
21 
2 
N/A 
1 
2 
1 

The main category of infringement found through inspections was non-conformity of the 
chemical  with  the  export  notification.  Infringements  related  to  SDS  and  labelling 
requirements were also found.  

Coordination  of  enforcement  activities  happens  through  the  Forum  for  Exchange  of 
Information,  with  both  the  Agency  and  the  DNAs  reporting  positive  feedback  on  Forum 
activities. Some DNAs welcomed the launch of a pilot project dedicated to enforcement of 
the PIC Regulation.  

4.13.  The first report pursuant to Article 20 was published 

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.  The  Agency  must 
therefore compile a report on all transmitted information every two years. 

The Agency published the first compilation of information transmitted to third countries in 
November  201613,  covering  the  first  two  years  of  implementation  of  the  PIC  Regulation 
(2014-2015).  The  Agency  did  not  experience  difficulties  in  collecting  the  transmitted 
information  from  the  Commission  and  the  Member  States.  The  only  challenge  was  to 
define  the  scope  of  the  report  with  the  Commission  and  Member  States,  as  it  was  the 
first of its kind. The Commission received and responded to two requests for information 
in 2014-2015 and four requests in 2016. 

4.14.  Several  DNAs  and  the  Agency  have  participated  in  technical 

assistance activities  

According  to  Article  21,  the  Commission,  DNAs  and  the  Agency  must  cooperate  in 

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

kept.  

13 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/regulations/prior-informed-consent-
regulation/reporting-on-information-exchange  

14 

 
 
 
 
 
 
 
 
 
                                                 
promoting  technical  assistance,  in  particular  to  help  developing  countries  and  countries 
with economies in transition to implement the Convention and develop the infrastructure, 
capacity and expertise needed to manage chemicals properly throughout their lifecycles. 

Five  Member  States  participated  in  cooperation  activities  and  six  in  projects  or 
international  activities  related  to  capacity-building  in  chemicals  management.  DNA 
activities  consisted  of  the  provision  of  technical  expertise  or  technical  information 
through  training  workshops,  visits,  twinning  projects,  etc.  The  Agency  organised  or 
participated in several capacity-building activities, either assisting EU candidate countries 
or  explaining  the  specific  provisions  of  the  PIC  Regulation  and  the  differences  with  the 
provisions of the Convention to authorities in non-EU countries. 

4.15.  ePIC  users  generally  found  the  IT  tool  user-friendly  and 

adequate to support their work  

As  requested  by  Regulation  (EU)  No  649/2012,  the  Agency  developed  and  continues  to 
maintain  the  IT  tool  (ePIC)  to  support  the  implementation  of  the  PIC  Regulation.  ePIC 
was launched in September 2014, shortly after the entry into force of the Regulation, and 
replaced  the  previous  EDEXIM  database.  The  Commission,  DNAs,  enforcement 
authorities, the Agency, exporters and importers, and customs officers all have access to 
ePIC.  

Overall,  DNAs  found  ePIC  to  be  user-friendly  and  did  not  experience  major  issues  in its 
use. Feedback from industry users to the Agency and DNAs was also generally positive, 
as was the feedback from customs and enforcement authorities. 

4.16.  Relevant  information  and  data  have  been  made  publicly 

available  

The  PIC  Regulation  contains  a  number  of  requests  to  make  information  and  data 
available to the public, and these have been duly implemented by the Agency. 

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 amendments14;  
  Article 10 reports on actual quantities of PIC chemicals exported and imported15; 
  Article 20 reports on information exchange16. 

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

  The list of chemicals subject to PIC17; 
  High-level information and statistics on export notifications18;  

14 PIC legislation: https://echa.europa.eu/regulations/prior-informed-consent/legislation  
15  Annual 

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

imports:  https://echa.europa.eu/regulations/prior-informed-

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

regulation/reporting-on-information-exchange  

17 Chemicals subject to PIC: https://echa.europa.eu/information-on-chemicals/pic/chemicals  
18 Export notifications: https://echa.europa.eu/information-on-chemicals/pic/export-notifications  

15 

 
 
 
 
 
 
 
 
 
 
                                                 
  High-level information and statistics on import notifications19;  
  Non-confidential data on explicit consents received from non-EU countries20;  
  EU and non-EU DNA contact details21.  

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

5.  CONCLUSIONS 

Regulation  (EU)  No  649/2012  implements  the  Rotterdam  Convention  in  the  EU  and  has 
the  same  objectives,  i.e.  to  promote  shared  responsibility  and  cooperation  in  the 
international  movement  of  hazardous  chemicals,  and  to  protect  human  health  and  the 
environment  from  potential  harm  by  facilitating  the  exchange  of  information  on 
hazardous  chemicals  and  their  trade.  Regulation  (EU)  No  649/2012  goes  beyond  the 
requirements of the Convention in order to offer a higher level of protection, in particular 
to developing countries and countries with economies in transition. 

This  report  demonstrates  that  the  procedures  established  by  Regulation  (EU)  No 
649/2012  operated  well  and  contributed  to  achieving  its  objectives.  Good  cooperation 
between  all  stakeholders  formed  the  basis  for  successful  implementation.  The  export 
notification  procedure  functioned  well  and  provided  the  importing  countries  with 
important  information  on  many  chemicals  and  their  export.  With  almost  8,000  export 
notifications  in  2016  and  its  continuing  upward  trend,  the  scale  of  the  information 
exchange and its potential to increase further is clearly visible. The related workload can 
only be handled with reasonable staff resources, given the need to maintain the capacity 
for  processing  and  support  while  ensuring  the  performance  of  the  IT  application  ‘ePIC’, 
developed and maintained by the Agency. 

The  explicit  consent  procedure,  which  goes  beyond  the  Convention  as  a  standard 
procedure  for  the  export  of  certain  chemicals,  has  led  to  the  high  number  of  3,362 
requests  for  explicit  consent  sent  to  importing  countries  in  the  reporting  period. 
Experience  suggested  that  those  requests  presented  a  challenge  for  many  importing 
countries, largely because the procedure is rarely used under the Convention and many 
Parties  may  not  be  aware  of  its  existence.  This  may  have  resulted  in  a  high  number  of 
exports  not  being  allowed  to  proceed  due  to  unanswered  requests  for  consent.  The 
possibility  to  apply  for  a  waiver  under  certain  conditions  ensured  that  the  number  of 
exports blocked for this reason was kept to a minimum.  

The  exporters  of  chemicals  subject  to  the  Regulation  were  generally  aware  of  their 
obligations  and  able  to  meet  them.  Where  problems  arose,  the  DNAs  and  the  Agency 
provided the necessary assistance, and this may have contributed to the low number of 
infringements.  The  main  category  of  infringement  found  through  inspections  was  non-
conformity of the chemical with the export notification. Infringements related to SDS and 
labelling requirements were also identified.  

In  general,  the  Member  States  met  their  obligations,  although  the  high  workload  at  the 
end  of  each  year  -  caused  by  the  large  number  of  export  notifications  –  presented  a 

19 Import notifications: https://echa.europa.eu/information-on-chemicals/pic/import-notifications   
20 Explicit consents: https://echa.europa.eu/information-on-chemicals/pic/explicit-consents  
21 DNAs: https://echa.europa.eu/information-on-chemicals/pic/designated-national-authority  

16 

 
 
 
 
 
 
 
 
                                                 
challenge for some Member States and sometimes led to problems with timeframes. The 
contribution  of  the  Agency  to  implementation  was  fully  in  line  with  the  requirements  of 
the  Regulation,  and  its  solid  performance  was  the  basis  for  effective  functioning  of  the 
relevant  procedures.  The  Commission  completed  its  obligations  under  the  Regulation. 
Two  Commission  Delegated  Regulations  amending  Annex  I,  as  well  as  two  Commission 
Implementing  Decisions  adopting  Union import  decisions,  were  adopted in the  reporting 
period.  In  addition,  the  Commission  coordinated  the  contribution  of  the  Union  to  the 
international work and represented the Union to the Convention. 

17