REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the delegation conferred on the Commission pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals
Date: 2023-07-17
Institutions: Directorate-General for Environment, European Commission
Subjects: European Commission, chemical product, dangerous substance, delegated legislation, environmental protection, export (EU), import (EU), powers of the institutions (EU), public health, transfer of competence

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 17.7.2023  COM(2023) 448 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the delegation conferred on the Commission pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals    
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL 

on the exercise of the delegation conferred on the Commission pursuant to Regulation 
(EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 
concerning the export and import of hazardous chemicals 

1. INTRODUCTION AND LEGAL BASIS 

Regulation (EU) No 649/20121 (hereinafter, “the PIC Regulation”) implements the Rotterdam 
Convention  on  the  Prior  Informed  Consent  Procedure  for  certain  hazardous  chemicals  and 
pesticides in international trade ("Rotterdam Convention"), signed on 11 September 1998 and 
approved,  on  behalf  of  the  European  Community,  by  Council  Decision  2003/106/EC2.  The 
requirements  and  procedures  for  export  and  import  of  certain  hazardous  chemicals,  in 
particular those that are subject to the prior informed consent procedure under the Rotterdam 
Convention, are laid down in the PIC Regulation.  

Article 23(4) of the PIC Regulation empowers the Commission to adopt delegated acts subject 
to the conditions laid down in Article 26 of that Regulation in order to: 

- include a chemical in Part 1 or 2 of Annex I pursuant to paragraph 2 of Article 23 following 
final  regulatory  action  at  Union  level,  and  other  amendments  of  Annex  I,  including 
modifications to existing entries [Article 23(4)(a)], 

-  include  a  chemical  that  is  subject  to  Regulation  (EC)  No  850/2004  of  the  European 
Parliament and of the Council of 29 April 2004 on persistent organic pollutants3 in Part 1 of 
Annex V [Article 23(4)(b)], 

-  include  a  chemical  already  subject  to  an  export  ban  at  Union  level  in  Part  2  of  Annex  V 
[Article 23(4)(c)], 

- modify existing entries in Annex V [Article 23(4)(d)], 

- amend Annexes II, III, IV and VI [Article 23(4)(e)].  

This  report  is  to  meet  the  obligation  set  for  the  Commission  by  Article  26(2)  of  the  PIC 
Regulation. Article 26(2) requires the Commission to present to the European Parliament and 
to the Council a report on the exercise of the delegation conferred on the Commission by the 
PIC Regulation. The report shall be drawn up not later than nine months before the end of the 
five-year  period  of  the  delegation,  running  initially  from  1  March  2014  and  for  this  second 
report from 1 March 2019. The delegation of power shall be tacitly extended for periods of an 
identical duration, unless the European Parliament or the Council opposes such extension not 
later than three months before the end of each period. 

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, p. 60). 
2 Council Decision 2003/106/EC of 19 December 2002 concerning the approval, on behalf of the European 
Community, of the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous 
chemicals and pesticides in international trade (OJ L 63, 6.3.2003, p. 27). 
3 Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent 
organic  pollutants  and  amending  Directive  79/117/EEC  (OJ  L  158,  30.4.2004,  p.  7)  has  been  repealed  and 
replaced  by  Regulation  (EU)  2019/1021  of  the  European  Parliament  and  of  the  Council  of  20  June  2019  on 
persistent organic pollutants (OJ L 169, 25.6.2019, p. 45). 

1 

 
 
 
                                                           
2. EXERCISE OF THE DELEGATION 

During  the  period  concerned  by  this  report,  the  Commission  adopted  four  delegated  acts  in 
order  to  amend  certain  non-essential  elements  of  the  PIC  Regulation.  Those  delegated  acts 
were adopted on the basis of Article 23(4)(a) of the PIC Regulation specifying: “In order to 
adapt  this  Regulation  to  technical  progress,  the  Commission  shall  be  empowered  to  adopt 
delegated acts in accordance with Article 26 concerning the inclusion of a chemical in Part 1 
or  2  of  Annex  I  pursuant  to  paragraph  2  of  Article  23  following  final  regulatory  action  at 
Union level,  and other amendments  of  Annex I, including  modifications to existing  entries”; 
on  the  basis  of  Article  23(4)(b)  specifying:  “In  order  to  adapt  this  Regulation  to  technical 
progress,  the  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  26  concerning  the  inclusion  of  a  chemical  that  is  subject  to  Regulation  (EC)  No 
850/2004  of  the  European  Parliament  and  of  the  Council  of  29  April  2004  on  persistent 
organic  pollutants  in  Part  1  of  Annex  V”;  on  the  basis  of  Article  23(4)(c)  specifying:  “In 
order to adapt this Regulation to technical progress, the Commission shall be empowered to 
adopt  delegated  acts  in  accordance  with  Article  26  concerning  the  inclusion  of  a  chemical 
already  subject  to  an  export  ban  at  Union level  in  Part  2  of  Annex  V”; and  on  the  basis  of 
Article  23(4)(d)  specifying:  “In  order  to  adapt  this  Regulation  to  technical  progress,  the 
Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with  Article  26 
concerning modifications to existing entries in Annex V”. 

The following acts were adopted: 

2.1. Commission Delegated Regulation (EU) 2019/3304 

This legal act was adopted on the basis of  points (a), (b), (c) and (d) of Article 23(4) of the 
PIC  Regulation.  The  approach  followed  in  the  delegated  act  to  determine  which  chemicals 
should be listed in Annex I and in which part they should be listed was subject to discussions 
and  consultations  within  an  expert  group  consisting  of  representatives  of  Member  States’ 
designated national authorities for the PIC Regulation, of the European Chemicals Agency, of 
industry and of the civil  society  (hereinafter, “PIC DNA Expert Group”)  in  the meetings  of 
24 April 2018  and  2 October 2018.  Those  meetings  of  the  PIC  DNA  Expert  Group  also 
discussed the listing of certain chemicals in Parts 1 and 2 of Annex V. The PIC DNA Expert 
Group  was  consulted  on  the  draft  Commission  Delegated  Regulation,  which  was  made 
available  in  advance  of  the  second  meeting.  The  Commission  adopted  the  delegated  act  on 
11 December 2018  and  notified  it  to  the  European  Parliament  and  the  Council.  Neither 
institution  objected  to  the  delegated  act  within  the  period  of  two  months  provided  for  in 
Article 26(5) of the PIC Regulation. Commission Delegated Regulation  (EU) 2019/330 was 
published on 27 February 2019 and applies from 1 May 2019.  

2.2. Commission Delegated Regulation (EU) 2019/17015 

This  legal  act  was  adopted  on  the  basis  of  points  (a)  and  (b)  of  Article  23(4)  of  the  PIC 
Regulation.  The  act  was  necessary  to  ensure  legal  clarity  and  consistency,  since  the 

4  Commission  Delegated  Regulation  (EU)  2019/330  of  11  December  2018  amending  Annexes  I  and  V  to 
Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import 
of hazardous chemicals (OJ L 59, 27.2.2019, p. 1). 
5 Commission Delegated Regulation (EU) 2019/1701 of 23 July 2019 amending Annexes I and V to Regulation 
(EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous 
chemicals (OJ L 260, 11.10.2019, p. 1). 

2 

 
 
                                                           
amendments  made  by  Commission  Regulation  (EU)  No  73/20136  to  Regulation  (EC)  No 
689/2008 of the European Parliament and of the Council7 were not duly reflected in the PIC 
Regulation. The PIC Regulation is a recast of Regulation (EC) No 689/2008 and replaced that 
Regulation  with  effect  from  1 March 2014.  It  should  be  noted  that  Regulation  (EU)  No 
73/2013  was  adopted  on  25  January  2013  but  was  only  applicable  from  1 April 2013,  thus 
after the adoption of the PIC Regulation, which was 4 July 2012. It was therefore necessary to 
formally reflect in the Annexes to the PIC Regulation the amendments set out in Regulation 
(EU) No 73/2013. The Commission adopted the delegated act on 23 July 2019 and notified it 
to the European Parliament and the Council. Neither institution objected to the delegated act 
within  the  period  of  two  months  provided  for  in  Article  26(5)  of  the  PIC  Regulation. 
Commission  Delegated  Regulation  (EU)  2019/1701  was  published  on  11 October 2019  and 
applies from 1 March 2014. 

2.3 Commission Delegated Regulation (EU) 2020/10688 

This  legal  act  was  adopted  on  the  basis  of  points  (a)  and  (c)  of  Article  23(4)  of  the  PIC 
Regulation. The approach followed in the delegated act to determine which chemicals should 
be listed in  Annex  I and in  which part they should  be listed was subject  to  discussions  and 
consultations  within  the  PIC  DNA  Expert  Group  in  the  meetings  of  9 April 2019  and 
15 October 2019. Those meetings of the PIC DNA Expert Group also discussed the listing of 
certain  chemicals  in  Part  2 of Annex V.  The PIC DNA Expert Group was  consulted on the 
draft Commission Delegated Regulation, which was made available in advance of the second 
meeting.  The  Commission  adopted  the  delegated  act  on  15 May 2020  and  notified  it  to  the 
European Parliament and the Council. Neither institution objected to the delegated act within 
the  period  of  two  months  provided  for  in  Article  26(5)  of  the  PIC  Regulation.  Commission 
Delegated  Regulation  (EU)  2020/1068  was  published  on  21 July 2020  and  applies  from 
1 September 2020. 

2.4 Commission Delegated Regulation (EU) 2022/6439 

This legal act was adopted on the basis of  points (a), (b), (c) and (d) of Article 23(4) of the 
PIC  Regulation.  The  approach  followed  in  the  delegated  act  to  determine  which  chemicals 
should be listed in Annex I and in which part they should be listed was subject to discussions 
and  consultations  within  the  PIC  DNA  Expert  Group  in  the  meetings  of  10 July 2020, 
5 November 2020,  23 April 2021  and  14 October 2021.  Those  meetings  of  the  PIC  DNA 
Expert Group also discussed the listing of certain chemicals in Parts 1 and 2 of Annex V. The 
PIC DNA Expert Group was consulted on the draft Commission Delegated Regulation, which 
was made available in advance of three meetings. The Commission adopted the delegated act 
on  10 February 2022  and  notified  it  to  the  European  Parliament  and  the  Council.  Neither 
institution  objected  to  the  delegated  act  within  the  period  of  two  months  provided  for  in 

6 Commission Regulation (EU) No 73/2013 of 25 January 2013 amending Annexes I and V to Regulation (EC) 
No  689/2008  of  the  European  Parliament  and  of  the  Council  concerning  the  export  and  import  of  dangerous 
chemicals (OJ L 26, 26.1.2013, p. 11). 
7 Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the 
export and import of dangerous chemicals (OJ L 204, 31.7.2008, p. 1). 
8 Commission Delegated Regulation (EU) 2020/1068 of 15 May 2020 amending Annexes I and V to Regulation 
(EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous 
chemicals (OJ L 234, 21.7.2020, p. 1). 
9  Commission  Delegated  Regulation  (EU)  2022/643  of  10  February  2022  amending  Regulation  (EU)  No 
649/2012 of the European Parliament and of the Council as regards the listing of pesticides, industrial chemicals, 
persistent organic pollutants and mercury and an update of customs codes (OJ L 118, 20.4.2022, p. 14). 

3 

 
 
                                                           
Article 26(5) of the PIC Regulation. Commission Delegated Regulation  (EU) 2022/643 was 
published on 20 April 2022 and applies from 1 July 2022. 

2.5 Delegated powers not used during the reporting period 

The  delegated  powers  of  the  PIC  Regulation  to  adopt  delegated  acts  in  accordance  with 
Article 23(4)(e) were not exercised during the reporting period since there were no changes in 
Union law or under the Convention requiring this. Since those changes can occur at any time, 
it is important that the Commission is empowered to adopt delegated acts that adapt the PIC 
Regulation to technical progress in line with those changes.  

3. CONCLUSION 

During  this  second  reporting  period  the  Commission  has  exercised  the  delegated  powers 
provided for by the PIC Regulation on four occasions and under the four legal bases referred 
to above. The Commission is of the view that the delegated powers conferred by Article 23(4) 
should be tacitly extended, including those that were not yet exercised since the need to adapt 
the PIC Regulation to technical progress in accordance with Article 23(4)(e) can occur at any 
time.  The  implementation  of  the  PIC  Regulation  is  advancing  and  technical  and  scientific 
progress  takes  place.  Developments  in  Union  law  and  under  the  Convention  need  to  be 
reflected  and  require  adaptations  of  the  Annexes  to  the  PIC  Regulation.  Therefore,  the 
Commission will be required to adopt further delegated acts in the future in order to keep the 
legal framework up to date. 

The  Commission  complies  with  the  reporting  requirement  under  Article  26(2)  of  the  PIC 
Regulation and invites the European Parliament and the Council to take note of this report.  

4