Proposal for a Regulation of the European Parliament and of the Council concerning the export and import of dangerous chemicals
Date: 2006-11-30
Institutions: European Commission
Subjects: chemical product, dangerous substance, exchange of information, export monitoring, import policy, international trade

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 30.11.2006 
COM(2006)745 final 

2006/0246 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

concerning the export and import of dangerous chemicals 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

•  Grounds for and objectives of the proposal 

Regulation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 
2003 concerning the export and import of dangerous chemicals Community1 ('the Regulation') 
implements  the  Rotterdam  Convention  on  the  Prior  Informed  Consent  (PIC)  Procedure  for 
certain hazardous chemicals and pesticides in international trade.  

On  10  January  2006,  in  its  judgment  in  case  Commission  v.  Parliament  and  Council2,  the 
Court of Justice annulled the Regulation, ruling that there should have been a dual legal basis 
including  both  Articles  133  and  175  first  paragraph  of  the  Treaty.  The  Court  however 
maintained the effects of the Regulation until the adoption, within a reasonable period of time, 
of a new regulation founded on appropriate legal bases.  

The  purpose  of  this  proposal  is  therefore  a  new  Regulation,  based  on  the  above-mentioned 
dual legal basis. At the same time, it is proposed to include certain technical amendments to 
the operative provisions in the light of a Commission report in accordance with Article 21 of 
the Regulation on the experience of the procedures to date. That report is being submitted in 
parallel to this proposal. 

•  General context 

The  Rotterdam  Convention  was  adopted  in  September  1998.  It  entered  into  force  on  24 
February 2004. 

In January 2002, the Commission put forward a proposal, based on Article 133 of the Treaty, 
for  a  Council  Regulation  concerning  the  export  and  import  of  dangerous  chemicals  to 
implement to the provisions of the Convention within the Community.  

After  the  European  Parliament  had  been  consulted  on  an  optional  basis  pursuant  to  Article 
133,  the  Council  unanimously  decided  to  replace  Article  133  by  Article  175(1).  The 
Parliament and the Council subsequently jointly adopted Regulation (EC) No 304/2003 of 28 
January 2003 concerning the export and import of dangerous chemicals.  

Article  21  of  the  Regulation  requires  that  the  Member  States  shall  regularly  forward  to  the 
Commission information on the  operation of the  procedures provided  for in  the  Regulation. 
The Commission shall compile this information in a synthesis report integrating also a report 
on  the  performance  of  the  functions  provided  for  in  the  Regulation  for  which  it  has 
responsibility. The first such overall summary report covering the period from entry into force 
of the Regulation up until the end of 2005 has recently been compiled. The overall conclusion 
of  the  report,  confirmed  by  regular  consultations  of  the  Member  States,  industry  and  other 
NGOs,  is  that  generally  the  procedures  are  working  well,  but  that  certain  technical 
amendments are warranted.  

1 
2 

OJ L 67, 6.3.2003, p.1 
Case C-178/03 

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In  addition  to  annulling  the  Regulation,  in  a  parallel  judgment3,  the  Court  annulled  for  the 
same reasons Council Decision 2003/106/EC of 19 December 2002 on the approval, on behalf 
of the European Community, of the Convention4.  

Although  the  annulment  of  that  Council  Decision  does  not  affect  the  original  Community 
ratification  of  the  Convention,  a  new  Council  Decision  is  required  with  the  dual  legal  base 
together  with  an  amended  declaration  of  competence  to  be  delivered  to  the  UN  depositary. 
The Commission recently put forward a separate proposal to that end, which was adopted by 
the Council on 25 September 2006 (Decision 2006/730/EC5). 

•  Existing provisions in the area of the proposal 

As noted above, the current Community rules relating to the export and import of dangerous 
chemicals  are  laid  down  in  Regulation  (EC)  No  304/2003,  as  most  recently  amended  by 
Commission Regulation (EC) No 777/20066. 

The  Regulation  goes  significantly  beyond  the  requirements  of  the  Convention.  The  key 
differences can be summarised as follows: 

•  the  rules  apply  to exports to all  countries, whether or  not they are  Parties to the 

Convention;  

•  a  wider  range  of  chemicals  are  subject  to  annual  export  notification.  For  the 
purposes of determining which chemicals should be subject to the procedure, the 
two  Convention  use  categories  (pesticides  and  industrial  chemicals)  are  divided 
into two subcategories each ( plant protection products and other pesticides such 
as biocides; and chemicals for professional use and chemicals for consumer use). 
Moreover  export  notification  has  to  be  made  irrespective  of  the  chemical's 
intended  use  and  whether  or  not  that  use  is  banned  or  severely  restricted  in  the 
EU.  Furthermore  chemicals  subject  to  the  international  PIC  procedure  ('PIC 
chemicals') and certain articles are also covered; 

•  PIC  chemicals  and  chemicals  that  are  banned  or  severely  restricted  in  the 
Community in a Convention use category cannot be exported without the explicit 
consent of importing countries; 

•  Certain  articles  and  chemicals  (such  those  chemicals  that  are  subject  also  to  the 
Stockholm Convention on Persistent Organic Pollutants) are banned for export; 

•  All  dangerous  chemicals  exported  to  third  countries  have  to  be  labelled  and 

packaged in the same way as they must be within the Community. 

3 
4 
5 
6 

Case C-94/03 Commission v Council 
OJ L63, 6.3.2003, p.27 
OJ L 299, 28.10.206, p.23 
OJ L 136, 24.5.2006, p. 9 

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•  Consistency with the other policies and objectives of the Union 

The proposal is fully in line with existing policies and objectives aimed at protecting human 
health and the environment globally such as those laid down in the 6th Environmental Action 
Programme. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

•  Consultation of interested parties 

211Consultation methods, main sectors targeted and the general background 

Numerous parties have been consulted within the framework of the meetings  of  Designated 
National  Authorities  (DNAs)  under  Regulation  (EC)  No  304/2003,  which  have  regularly 
reviewed  issues  relating  to  implementation.  Participants  have  included  stakeholders  such  as 
industry and NGOs as well as Member States, all of whom have had an opportunity to give 
their  opinions  and  to  make  comments  and  been  invited  to  make  written  submissions  on 
particular issues.  

In addition, Member States were able to comment on problems relating to implementation in 
their reports made pursuant to Article 21 of the Regulation. 

212Summary of responses and how these have been taken into account 

The responses confirmed the need for a limited number of technical amendments to improve 
the functioning of the Regulation without changing its objectives and core provisions. These 
have been taken into account in the drafting of this proposal. 

•  Collection and use of expertise 

No recourse to external expertise has been necessary.  

•  Impact assessment 

The  current  rules  are  generally  working  well.  A  new  regulation  with  certain  technical 
amendments is the only feasible option. Overall the impact of the proposed new regulation is 
expected to be limited. The main effects will be as follows:  

–  There will be more clarity and transparency and increased legal certainty;  

–  Control  of  exports  by  customs  will  be  enhanced,  without  unduly  impeding  trade  that 

complies with the rules; 

–  There will not be any additional administrative burdens for exporters and authorities. On 
the contrary, in certain respects the proposed amendments will lead to a reduction. On the 
other hand, the burden for the Commission would increase to some extent; 

–  The  current  high  level  of  protection  for  human  health  and  the  environment  will  be 

maintained.  

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3. 

LEGAL ELEMENTS OF THE PROPOSAL 

•  Summary of the proposed action 

Subject  to  the  required  change  of  the  legal  basis,  the  proposed  new  Regulation  would 
essentially  maintain  all  the  provisions  of  the  current  Regulation,  including  those  that  go 
beyond  the  requirements  of  the  Convention.  However,  as  confirmed  in  the  Commission's 
report  under  Article  21,  experience  of  the  existing  arrangements  has  shown  that  certain 
technical  amendments  are  needed  to  improve  the  functioning  of  the  Regulation.  The  main 
changes are as follows. 

Changes and clarifications as regards certain definitions (Article 3) 

Exporter 

Under  the  Regulation,  the  exporter  is  essentially  defined  as  the  legal  person  shown  on  the 
shipping  documents  as  the  person  with  a  contract  with  the  consignee  and  responsible  for 
determining the sending of the chemical out of the EC customs territory. However there have 
been problems in applying this definition in the context of the export notification procedure, 
which requires the exporter to notify the DNA of the Member State in which he is established, 
since  sometimes  the  exporter  can  be  a  trader  not  established  in  the  Community  who  has 
obtained  the  chemicals  from  an  EC  chemical  manufacturer  or  distributor.  It  is  therefore 
proposed to adapt the definition to cover this situation. 

Preparation 

Under the Regulation, ‘preparation’ is defined as meaning a mixture or a solution composed 
of two or more substances, if the preparation, as defined in Directive 1999/45/EC, is subject 
to compulsory labelling under Community legislation, on account  of the presence  of any of 
those  substances.  This  rather  broad  definition  is  appropriate  in  the  context  of  Article  16, 
which  relates  to  all  exported  dangerous  chemicals.  However  it  has  caused  some  questions 
about  the  scope  of  the  obligations  as  regards  other  operative  provisions,  particularly  those 
relating to export notification and explicit consent under Articles 7 and 13 respectively. It is 
therefore proposed to revise the definition and to make it clearer in those operative provisions 
that preparations are only subject to the requirements when they contain a chemical(s) listed 
in the relevant part(s) of Annex I of the Regulation to the extent that its presence is such that it 
could trigger labelling, irrespective of the presence of any other substances in the preparation. 

Changes and clarifications to the so-called 'explicit consent' procedure (Article 13.6) 

In  around  half  of  the  cases  to  date,  despite  the  efforts  made  by  the  DNAs  of  the  exporting 
Member  States  to  obtain  explicit  consent,  no  response  is  forthcoming  from  the  importing 
country, in some cases for many months or even years. As a result, exports cannot proceed, 
despite the fact that often the substances are not banned or severely restricted in the importing 
countries.  The  current  system  thus  causes  difficulties  for  exporters  and  exporting  DNAs 
without  necessarily  affording  greater  protection  to  importing  countries.  The  situation  as 
regards chemicals listed in part 2 of Annex I (chemicals banned or severely restricted in the 
EC within a Convention use category and thus qualifying for PIC notification but that are not 
yet PIC chemicals) is particularly problematic.  

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Against  this  background,  certain  limited  possibilities  for  exports  to  proceed  on  a  temporary 
basis,  while  further  efforts  are  made  to  obtain  explicit  consent,  seem  appropriate.  It  is 
proposed that, if, despite all reasonable efforts by the exporter’s DNA and the Commission, 
there is no response  within  2  months,  available documentary evidence from official sources 
that  the  chemical  is  registered,  authorised  or  otherwise  allowed  for  use  in  the  importing 
country can be regarded as sufficient indication of consent for exports to proceed ad interim 
pending a response. This  would  be  compatible  with the so-called "status quo" provisions of 
Article  11.2  of  the  Convention,  but  would  be  more  restrictive.  Moreover  registration 
certificates  etc  are  frequently  specific  to  a  given  product  and  supplier  so  that  the  scope  for 
exports to proceed would be limited accordingly. Furthermore, it is proposed that if there is no 
response after 3 months, exports can proceed for a maximum 12 months pending  receipt of 
explicit  consent  to  subsequent  exports.  It  also  proposed  that  where  chemicals  are  being 
exported to OECD countries the requirement can be waived if certain conditions are fulfilled. 

The  rules  as  regards  the  period  of  validity  of  explicit  consents  obtained  would  also  be 
clarified. The current provisions imply that consents obtained (unless otherwise qualified by 
the  importing  country)  are  potentially  open-ended.  However  it  is  proposed  that  consents 
obtained,  as  well  as  cases  where  alternative  evidence  is  accepted,  should  be  periodically 
reviewed. 

To  further  improve  and  strengthen  the  functioning  of  the  system,  it  is  also  proposed  that 
requests for consent and renewals should be channelled through the Commission (subject to 
the  necessary  resources  being  made  available).  This  would  help  to  prevent  the  unnecessary 
overlaps or duplication of effort that sometimes can occur. It may also help to avoid possible 
misunderstandings  and  confusion  in  importing  countries,  which  currently  receive  export 
notifications from the Commission and requests for consent from the Member States. 

Changes to reinforce and strengthen customs control of exported chemicals while at the same 
time facilitating trade (Article 17) 

In most Member States the customs authorities play a key role in ensuring compliance with 
the  Regulation,  in  particular  as  regards  controlling  exports.  In  order  to  meet  their  specific 
needs in this regard, several actions are already in hand, as follows.  

•  classifying chemicals subject to Regulation 304/2003 within the Combined Nomenclature 
(CN)  so  that  'warning  flags'  could  be  included  in  the  Integrated  Tariff  of  the  European 
Communities (TARIC) against the relevant CN codes that would alert customs officers to 
the fact that the chemicals concerned are or could be subject to special rules. 

•  developing  a  version  of  the  Commission's  EDEXIM  database  (which  includes  data  on 
export  notifications  made,  explicit  consents  obtained  etc)  specifically  for  customs 
authorities. This would help them to check whether or not a particular export shipment can 
be allowed to proceed. To facilitate this, it is planned that there should be unique reference 
or code numbers generated by the system that would be quoted by exporters in their export 
declarations. Customs officers would be able if necessary to check these code numbers on 
EDEXIM  to  verify  compliance.  Linked  to  this  initiative,  work  is  also  well  advanced  in 
providing  in  TARIC  for  such  codes  to  be  used  by  exporters  in  section  44  of  the  export 
declaration form (the Single Administrative Document). 

Work on the above package of measures is expected to be completed in advance of adoption 
of the new Regulation. In order for such a system to be fully effective, it is proposed to make 

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the use of the codes by exporters a requirement in the new Regulation. However there would 
be a short grace period of three months following entry into force to enable all concerned to 
become familiarised with the system. 

All  this  would  obviate  the  need  for  supporting  documents  to  be  submitted  with  export 
declarations, which would thus help customs control but also reduce the administrative burden 
on both customs and exporters, thereby facilitating trade. 

•  Legal basis 

In line with the judgment of the Court, the proposed new Regulation is based on Article 133 
(relating to the  Common Commercial Policy) and Article  175(1) (relating  to Environmental 
Protection) of the Treaty.  

•  Subsidiarity principle 

The  proposal  does  not  fall  under  the  exclusive  competence  of  the  Community.  It  fully 
complies  with  the  principle  of  subsidiarity  since  its  objectives  cannot  be  achieved  by  the 
Member States because a harmonised approach is needed to ensure that the Community, as a 
Party to the Convention, meets its international obligations. 

•  Proportionality principle 

The  proposal  complies  with  the  proportionality  principle  since  it  is  based  on  experience 
gained  within  the  existing  system.  It  concentrates  on  changes  only  where  they  are  deemed 
necessary and appropriate for its proper functioning. 

The  proposal  aims  to  minimise  the  administrative  burden  without  prejudicing  the  level  of 
protection afforded to human health and the environment. 

•  Choice of instrument 

Given  that  the  existing  legislation  to  be  replaced  is  in  the  form  of  a  Regulation,  this  is  the 
most appropriate instrument.  

4. 

BUDGETARY IMPLICATION 

The  proposal  has  no  implication  for  the  Community  budget,  except  the  need  for  limited 
additional  staff  resources  to  deal  with  the  work  arising  from  the  proposed  changes  to  the 
Commission role in the explicit consent procedure. (see financial statement attached). 

5. 

ADDITIONAL INFORMATION 

•  Detailed explanation of the proposal 

The  proposed  Regulation  would  replace  the  existing,  but  most  of  the  provisions  would  be 
unchanged and the structure (including the numbering of the Articles) would be the same. The 
following summarises the main content of the proposed Regulation. 

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Article 1 

This  Article  outlines  the  objectives  of  the  Regulation,  which  are  in  line  with  the  overall 
objectives of the Convention. 

Article 2 

This  outlines  the  scope  of  the  Regulation.  The  exemptions  are  broadly  in  line  with  those 
provided  for  in  the  Convention,  with  certain  clarifications,  taking  into  account  relevant 
Community legislation.  

Article 3 

Article  3  sets  out  the  definitions,  including  those  taken  from  the  definitions  used  in  the 
Convention, adapted as necessary.  

A number of definitions in the existing Regulation have been amended as follows: 

– 

– 

– 

– 

A  revised  definition  for  'exporter'  has  been  introduced  to  address  the  enforcement 
problems referred to above.  

The definition of 'preparation' has been revised and the scope of the rules of Articles 
7, 9, 13 and 14(1) in relation to preparations clarified. 

The definitions of' Chemical subject to the PIC procedure', 'Party to the Convention' 
and  'Party'  have  been  adapted  to  take  account  of  the  entry  into  force  of  the 
Convention. 

The  definitions  of  'Convention',  'PIC  procedure',  the  'Conference  of  the  Parties' 
'Chemical  Review  Committee',  'the  Secretariat'  and  'Decision  Guidance  Document' 
are not strictly necessary and are introduced when mentioned for the first time in the 
operative provisions.  

Article 4 

The wording of this Article, relating to designated authorities, is in line with the Convention 
and is essentially unchanged.  

Article 5 

This  Article  relates  to  the  Community’s  participation  in  the  Convention,  including  the 
Commission's role as the common designated authority for the Community.  

Article 6 

This  Article  defines  the  chemicals  that  are  subject  to  export  notification,  qualify  for  PIC 
notification, and are subject to the international PIC procedure.  

Article 7 

Article 7 sets out the export notification procedure. It applies to all exports of chemicals that 
are listed in Part 1 of Annex I to the proposed Regulation. The notification must provide the 

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information  laid  down  in  Annex  III.  The  Commission  will  have  the  central  role  in  sending 
notifications  to  importing  countries  and  there  will  continue  to  be  a  centralised  register  of 
notifications  on  the  Commission’s  EDEXIM  database.  The  only  substantive  change  is,  as 
indicated  above,  the  introduction  of  unique  code  numbers  for  export  notifications  that  are 
verified as complete, of which exporters will be informed so that these can be quoted in their 
export declarations.  

Article 8 

This Article outlines the procedure for handling export notifications from third countries..  

Article 9 

Article 9 requires annual reporting on the quantities of Annex I chemicals traded. 

Article 10 

This  Article  provides  that  where  a  chemical  qualifies  for  PIC  notification  following  final 
Community  regulatory  action,  the  Commission  shall  notify  the  Convention’s  Secretariat, 
providing the information laid down in Annex II.  

Member  States  may  notify  national  regulatory  actions  compatible  with  Community  law. 
Following  a  prior  consultation  procedure  involving  all  other  Member  States,  these  can  be 
submitted to the Convention secretariat via the Commission. 

Article 11 

This Article provides that when a chemical is banned or severely restricted, but fails to qualify 
as  a  candidate  for  PIC  notification  under  Article  10,  the  Commission  will  inform  the  PIC 
Secretariat  of  the  relevant  regulatory  action  under  the  Convention's  information  exchange 
provisions. 

Article 12 

Article  12  deals  with  obligations  in  relation  to  imports  of  chemicals.  It  lays  down  the 
procedure  for  handling  decision  guidance  documents  for  PIC  chemicals;  and  taking 
Community import decisions for the chemicals concerned.  

Article 13 

This Article  sets out certain obligations in relation  to exports  other than export notification. 
There are two main elements.  

The  first  relates  mainly  to  procedures  for  PIC  chemicals  (listed  in  Part  3  of  Annex  I  to  the 
Regulation)  and  ensuring  that  the  import  decisions  of  importing  parties  are  respected.  The 
basic principle, which goes much further than the Convention, is that such chemicals should 
not be exported without the explicit consent of the importing country. The same approach is 
applied  to  any  chemical  that  is  banned  or  severely  restricted  within  the  Community  and 
qualifies for PIC notification but is not a PIC chemical.  

For the reasons explained in section 3 above, it is proposed  that under  certain conditions in 
cases where the importing country fails to respond, exports may proceed on a limited basis ad 

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interim pending a response. It is also proposed that under certain conditions the requirement 
can be waived for exports to OECD countries. In addition, it is proposed that the validity of 
consents obtained and waivers granted should be regularly reviewed. Explicit consent must be 
sought and received  via the DNA in the exporting Member  State.  However, for  the reasons 
already explained in section 3, it is proposed, subject to the necessary resources being made 
available,  that  all  requests,  including  requests  for  renewals,  should  be  routed  through  the 
Commission, which will post the information on EDEXIM. 

The  second  element  comprises  obligations  of  a  more  general  nature.  For  example  certain 
minimum standards  are imposed  as regards the useful  life of exported chemicals, the purity 
specifications  of  pesticides  and  their  packaging,  storage  and  stability  in  order  to  minimise 
risks under conditions of use in developing countries. 

Article 14 

Article 14 extends the export notification procedure laid down in Article 7 to certain articles. 
It  also  provides  for  certain  chemicals  and  articles,  the  use  of  which  is  prohibited  in  the 
Community, not to be exported. These chemicals and articles are listed in Annex V.  

Article 15 

This Article deals with the question of information on transit movements for PIC chemicals. 
The details of the importing Parties requiring information, and what type of information, will 
be set out, as they become available, in Annex VI.  

Article 16 

Article  16  lays  down  the  rules  applicable  to  information  to  accompany  exported  chemicals. 
Without  prejudice  to  the  requirements  of  the  importing  country,  and  taking  into  account 
relevant  international  standards,  all  dangerous  chemicals  for  export  should  be  subject  to 
packaging  and  labelling  and  be  accompanied  by  a  safety  data  sheet  in  accordance  with 
relevant Community legislation. As far as possible the information should be in the principal 
language(s) of the importing country. 

Article 17 

Article 17 refers to the role of the Customs Services of the Member States under the proposed 
Regulation.  

It is proposed to strengthen and facilitate control by introducing a requirement that exporters 
must  include  special  code  numbers  in  their  export  declarations  corresponding  to  the  export 
notifications  they  have  made  and  the  explicit  consents  or  waivers  obtained.  Corresponding 
provisions  are  included  in  Articles  7  and  13  providing  for  such  code  numbers  to  be  made 
available to exporters for such use.  

Article 18 

This Article is a standard provision for penalties in the event of infringements. 

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Article 19 

Article  19  reflects  the  provisions  of  the  Convention  relating  to  information  exchange,  but 
extends these arrangements to all countries. It also defines what kinds of information shall not 
be regarded as confidential for these purposes. 

Article 20 

This  Article  concerns  technical  assistance  to  developing  countries  and  countries  with 
economies in transition.  

Article 21 

Article 21 deals with monitoring and reporting within the Community on the operation of the 
proposed Regulation.  

Article 22 

Article 22 sets out the procedures to be followed for updating all annexes. In the light of the 
recent  changes  to  the  procedures  for  the  exercise  of  implementing  powers  conferred  on  the 
Commission7 , the current regulatory procedure for additions to Annex I has been changed to 
a  regulatory  procedure  with  scrutiny.  It  is  proposed  that  inclusion  of  POPs  chemicals  in 
Annex V should be subject to the same procedure. 

Article 23 

This  Article  provides  that  technical  guidance  documents  will  be  drawn  up  to  help  in 
implementation.  There  have  been  similar  documents  under  the  existing  Regulation.  The 
documents  to  be  developed  will  include  guidance  for  the  authorities  involved  in  controlling 
exports and imports such as customs authorities. 

Article 24 

This  Article  outlines  the  committee  procedures  to  be  followed,  using  the  committee 
established by Article 29 of Council Directive 67/548/EEC. These provisions also have been 
adapted in line with the revised procedures for the exercise of implementing powers conferred 
on the Commission referred to above. 

Articles 25 and 26 

These two Articles relate respectively to references to Regulation (EC) No 304/2003 in other 
legislation; and entry into force of the proposed new Regulation. A short transitional period of 
3  months  is  foreseen  before  entry  into  force  of  the  Article  17  provisions  relating  to  the 
mandatory use of code numbers in export declarations. 

7 

Council decision 1999/468/EC as amended by Decision 2006/512/Ec (OJ L200, 22.7.2006, p.11) 

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Annexes 

Annex I to the Regulation lists the chemicals subject to the different procedures and is based 
on that contained in Regulation (EC) No 304/2003 as amended by Commission Regulations 
1213/2003, 775/2004 and 777/2006.  

Annex  II  sets  out  the  information  that  must  be  submitted  by  when  the  Commission  notifies 
final Community regulatory action pursuant to Article 10.  

Annex  III  lists  the  information  that  by  an  exporter  must  submit  in  an  export  notification 
pursuant to Article 7. Certain clarifications have been introduced. 

Annex  IV  sets  out  the  information  to  be  provided  pursuant  to  Article  9  about  trade  in 
chemicals listed in Annex I. The scope of the quantities to be reported has been clarified 

Annex  V  lists  the  chemicals  and  articles  that  shall  not  be  exported  in  accordance  with 
Article 14(2). 

Annex  VI  lists  parties  requiring  information  on  transit  movement  of  PIC  chemicals 
(Article 15 refers). 

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2006/0246 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

concerning the export and import of dangerous chemicals 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular  Article  133 
and Article 175(1), thereof, 

Having regard to the proposal from the Commission8, 

Having regard to the Opinion of the European Economic and Social Committee9, 

Having consulted the Committee of the Regions, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty10, 

Whereas: 

(1) 

(2) 

Regulation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 
2003  concerning  the  export  and  import  of  dangerous  chemicals11  implemented  the 
Rotterdam 
Convention  on  the  prior  informed  consent  procedure  for  certain  hazardous 
chemicals and pesticides in international trade, hereinafter “the Convention”, which entered 
into force on 24 February 2004, and replaced Council Regulation (EEC) No 2455/92 of 23 
July 1992 concerning the export and import of certain dangerous chemicals12.  

In  its  judgment  of  10  January  2006  in  case  C-178/03  (Commission  v.  Parliament  and 
Council)13
 , the Court of Justice of the European Communities annulled Regulation (EC) No 
304/2003 as it was based solely on Article 175(1) of the Treaty, ruling that both Articles 133 
and 175(1) were the appropriate legal bases. However the Court also ruled that the effects of 
the  Regulation  were  maintained  until  the  adoption,  within  a  reasonable  period,  of  a  new 
Regulation founded on appropriate legal bases. That also implies that obligations that were 
fulfilled under Regulation (EC) No 304/2003 already do not need to be accomplished again. 

(3) 

In  accordance  with  Article  21  of  Regulation  (EC)  No  304/2003,  the  Commission  has 
submitted  a  report  to  the  European  Parliament  and  the  Council  on  the  operation  of 

8 
9 
10 
11 

12 

13 

EN 

OJ L 63, 6.3.2003, p. 1 Regulation as last amended by Commission Regulation (EC) No 777/2006 (OJ L 136, 
24.5.2006, p. 9). 
OJ L 251, 29.8.1992, p. 13. Regulation as last amended by Commission Regulation (EC) No 300/2002 ( OJ L 
52, 22.2.2002p.1) 
Not yet reported 

13 

   EN 

 
                                                 
 
 
 
Regulation (EC) No 304/2003 to date14. Overall the procedures have worked well. However 
the  report  identifies  a  number  of  technical  amendments  that  appear  to  be  necessary.  It  is 
therefore appropriate to integrate those aspects in this Regulation. 

It is necessary and appropriate, in order not to weaken the level of protection afforded to the 
environment  and  to  the  general  public  of  importing  countries  under  Regulation  (EEC)  No 
2455/92,  to  go  further  than  the  provisions  of  the  Convention  in  certain  respects,  Article 
15(4)  of  the  Convention  allowing  Parties  the  right  to  take  action  that  is  more  stringently 
protective  of  human  health  and  the  environment  than  that  called  for  in  the  Convention, 
provided  that  such  action  is  consistent  with  the  provisions  of  the  Convention  and  is  in 
accordance with international law. 

As  regards  the  participation  of  the  Community  in  the  Convention,  it  is  essential  to  have  a 
single contact point for Community interaction with the Secretariat and other Parties to the 
Convention  as  well  as  with  other  countries.  The  Commission  should  act  as  this  contact 
point. 

Exports of dangerous chemicals that are banned or severely restricted within the Community 
should  continue  to  be  subject  to  a  common  export  notification  procedure.  Accordingly, 
dangerous chemicals, whether in the form of a substance by itself or in a preparation, which 
have been banned or severely restricted by the Community as plant protection products, as 
other forms of pesticides, or as industrial chemicals for use by professional users or by the 
public,  should  be  subject  to  similar  export  notification  rules  to  those  applicable  to  such 
chemicals  when  they  are  banned  or  severely  restricted  within  either  or  both  of  the  use 
categories laid down in the Convention, namely as pesticides or chemicals for industrial use. 
In addition, chemicals subject  to the international PIC procedure should also be subject to 
the same rules. This export notification procedure should apply to Community exports to all 
third  countries,  whether  or  not  they  are  Parties  to  the  Convention  or  participate  in  its 
procedures.  Member  States  should  be  permitted  to  charge  administrative  fees,  in  order  to 
cover their costs in carrying out this procedure. 

Exporters  and  importers  should  be  obliged  to  provide  information  about  the  quantities  of 
chemicals  in  international  trade  covered  by  this  Regulation  in  order  that  the  impact  and 
effectiveness of the arrangements laid down therein can be monitored and assessed. 

Notifications to the Secretariat of the Convention of Community or Member State regulatory 
actions  banning  or  severely  restricting  chemicals,  with  a  view  to  their  inclusion  in  the 
international  PIC  procedure,  should  be  submitted  by  the  Commission  and  should  relate  to 
those  cases  meeting  the  criteria  laid  down  in  the  Convention  in  this  regard.  Additional 
information to support such notifications should be sought where necessary. 

In  cases  where  Community  or  Member  State  regulatory  actions  do  not  qualify  for 
notification  because  they  do  not  meet  the  criteria,  information  about  the  actions  should 
nevertheless be conveyed to the Convention Secretariat and other Parties to the Convention 
in the interests of information exchange. 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

It is also necessary to ensure that the Community takes decisions with regard to the import 
into the Community of chemicals that are subject to the international PIC procedure. These 
decisions should be based on applicable Community legislation and take into account bans 

14 

XXX 

EN 

14 

   EN 

 
                                                 
or  severe  restrictions  by  Member  States.  Where  justified,  modifications  of  Community 
legislation should be prepared. 

(11)  Arrangements  are  needed  to  ensure  that  Member  States  and  exporters  are  aware  of  the 
decisions  of  importing  countries  as  regards  chemicals  that  are  subject  to  the  international 
PIC  procedure,  and  that  exporters  comply  with  these  decisions.  Furthermore,  in  order  to 
prevent undesired exports no chemicals banned or severely restricted within the Community 
that meet the Convention criteria or that are covered under the international PIC procedure 
should be exported unless the explicit consent of the importing country concerned has been 
sought and obtained, whether or not that country is a Party to the Convention. At the same 
time, a waiver from this obligation is appropriate in relation to exports of certain chemicals 
to  OECD  countries  provided  that  certain  conditions  are  met.  Furthermore  a  procedure  is 
needed to deal with cases where despite all reasonable efforts, no response is obtained from 
the importing country so that exports may proceed on a temporary basis. It is also necessary 
to  provide  for  periodic  review  of  all  such  cases  as  well  those  where  explicit  consent  is 
obtained. 

(12) 

It is also important that all exported chemicals have an adequate shelf-life so that they may 
be  used  effectively  and  safely.  In  particular  as  regards  pesticides,  and  especially  those 
exported  to  developing  countries,  it  is  essential  that  information  about  appropriate  storage 
conditions is provided and that suitable packaging and sizes of containers are used to avoid 
creating obsolete stocks. 

(13)  Articles containing chemicals do not fall within the scope of the Convention. Nevertheless, 
it  seems  appropriate  that  articles  containing  chemicals  that  could  be  released  under 
conditions  of  use  or  disposal  and  that  are  banned  or  severely  restricted  in  the  Community 
within one or more of the use categories laid down in the Convention or are subject to the 
international  PIC  procedure  should  also  be  subject  to  the  export  notification  rules. 
Furthermore, certain chemicals and articles containing specific chemicals falling outside the 
scope of the Convention but giving rise to particular concern should not be exported at all.  

(14) 

In accordance with the Convention, information on transit movements of chemicals subject 
to  the  international  PIC  procedure  should  be  provided  to  Parties  to  the  Convention 
requesting such information. 

(15)  Community rules on packaging and labelling and other safety information should apply to 
all dangerous chemicals when intended for export to Parties and other countries unless these 
provisions  would  conflict  with  any  specific  requirements  of  those  countries  taking  into 
account relevant international standards. 

(16) 

In order to ensure effective control and enforcement of the rules, the Member States should 
designate  authorities  such  as  customs  authorities  that  should  have  the  responsibility  of 
controlling imports and exports of chemicals covered by this Regulation. The Commission 
and the Member States have a key role to play and should act in a targeted and coordinated 
way. Member States should provide for appropriate sanctions in the event of infringements. 
To facilitate customs control, and to reduce the administrative burden for both exporters and 
authorities,  a  system  of  codes  confirming  compliance  with  the  rules  to  be  used  in  export 
declarations is established. In order to allow all parties time to become accustomed to this 
system before it becomes mandatory a short transitional period is proposed. 

(17) 

Information exchange, shared responsibility and cooperative efforts between the Community 
and its Member States and third countries should be promoted with a view to ensuring sound 

EN 

15 

   EN 

 
management  of  chemicals,  whether  or  not  those  third  countries  are  Parties  to  the 
Convention.  In  particular,  technical  assistance  to  developing  countries  and  countries  with 
economies  in  transition  should  be  provided  directly  by  the  Commission  and  the 
Member States,  or  indirectly  via  support  for  projects  by  non-governmental  organisations 
(NGOs),  especially  assistance  seeking  to  enable  those  countries  to  implement  the 
Convention.  

(18)  There  should  be  regular  monitoring  of  the  operation  of  the  procedures  if  they  are  to  be 
effective.  To  this  end,  Member  States  should  regularly  submit  reports  to  the  Commission, 
which will in turn regularly report to the European Parliament and the Council. 

(19)  Technical  notes  for  guidance  should  be  drawn  up  to  assist  the  competent  authorities, 

including those such as customs controlling exports, in the application of the Regulation. 

(20)  The  measures  necessary  for  the  implementation  of  this  Regulation  should  be  adopted 
in accordance  with  Council  Decision 1999/468/EC  of  28 June 1999  laying down  the 
procedures for the exercise of implementing powers conferred on the Commission15, 

(21) 

In particular power should be conferred on the Commission to adopt measures to add further 
chemicals  to  Annex  I  and  chemicals  subject  to  Regulation  (EC)  No  850/2004  of  the 
European Parliament and of the Council16 to Annex V. Since those measures are of general 
scope and are designed to supplement this Regulation by the addition of new non-essential 
elements, they should be adopted in accordance with the regulatory procedure with scrutiny 
provided for in Article 5a of Decision 1999/468/EC, 

HAVE ADOPTED THIS REGULATION: 

1. 

The objectives of this Regulation are the following: 

Article 1 
Objectives 

(a) 

(b) 

to  implement  the  Rotterdam  Convention  on  the  Prior  Informed  Consent  Procedure 
for  Certain  Hazardous  Chemicals  and  Pesticides  in  International  Trade,  hereinafter 
“the Convention”; 

to  promote  shared  responsibility  and  cooperative  efforts  in  the  international 
movement  of  hazardous  chemicals  in  order  to  protect  human  health  and  the 
environment from potential harm;  

(c) 

to contribute to their environmentally sound use. 

They  shall  be  achieved  by  facilitating  information  exchange  about  the  characteristics  of 
such  chemicals,  by  providing  for  a  decision-making  process  within  the  Community  on 
their  import  and  export  and  by  disseminating  decisions  to  Parties  and  other  countries  as 
appropriate. 

15 
16 

OJ L 184, 17.7.1999, p. 23, Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p.11). 
OJ L 158, 30.4.2004, p.7 

EN 

16 

   EN 

 
                                                 
2. 

In addition to the objectives referred to in paragraph 1, this Regulation shall ensure that the 
provisions  of  Council  Directive 67/548/EEC17,  and  of  Directive  1999/45/EC  of  the 
European  Parliament  and  of  the  Council 18,  regarding  the  classification,  packaging  and 
labelling of chemicals dangerous to man or to the environment when they are placed on the 
market in the Community also apply to all such chemicals when they are exported from the 
Member  States  to  other  parties  or  other  countries,  unless  these  provisions  would  conflict 
with any specific requirements of those parties or other countries. 

1. 

This Regulation shall apply to the following: 

Article 2 
Scope 

(a) 

(b) 

(c) 

certain hazardous chemicals that are subject to the prior informed consent procedure 
under the Convention, hereinafter ” the PIC procedure”; 

certain  hazardous  chemicals  that  are  banned  or  severely  restricted  within  the 
Community or a Member State;  

chemicals when exported insofar as their classification, packaging and labelling are 
concerned.  

2. 

This Regulation shall not apply to any of the following: 

(a) 

narcotic  drugs  and  psychotropic  substances  covered  by  Council  Regulation  (EC) 
No 111/200519; 

(b) 

radioactive materials and substances covered by Council Directive 96/29/Euratom20; 

(c) 

(d) 

(e) 

(f) 

(g) 

wastes  covered  by  Directive  2006/12/EC of  the  European  Parliament  and  of  the 
Council21 and Council Directive 91/689/EEC22; 

chemical weapons covered by Council Regulation (EC) No 1334/200023; 

food  and  food  additives  covered  Regulation  (EC)  No  882/2004  of  the  European 
Parliament and of the Council 24; 

feedingstuffs covered by Regulation (EC) No 178/2002 of the European Parliament 
and  of  the Council25  including  additives,  whether  processed,  partially  processed  or 
unprocessed, intended to be used for oral feeding to animals; 

genetically  modified  organisms  as  covered  by  Directive  2001/18/EC  of  the 
European Parliament and of the Council26; 

17 
18 
19 
20 
21 
22 
23 
24 
25 

OJ L 196, 16.8.1967, p. 1.. 
OJ L 200, 30.7.1999, p. 1.. 
OJ L 22, 26.1.2005, p. 1. 
OJ L 159, 29.6.1996, p. 1. 
OJ L 165, 30.4.2004, p. 1. 
OJ L 377, 31.12.1991, p. 20. 
OJ L 159, 30.6.2000, p. 1. 
OJ L 186, 30.6.1989, p. 23. 
OJ L 31, 1.2.2002, p. 1. 

EN 

17 

   EN 

 
                                                 
(h) 

(i) 

save  to  the  extent  covered  by  Article  3(4)(b)  of  this  Regulation,  proprietary 
medicinal  products  and  veterinary  medicinal  products  covered  by  Directive 
2001/83/EC  of  the  European  Parliament  and  of  the  Council27  and  Directive 
2001/82/EC of the European Parliament and of the Council 28; 

chemicals  in  quantities  not  likely  to  affect  health  or  the  environment,  and  in  any 
event  not  more  than  10  kg,  provided  that  they  are  imported  for  the  purpose  of 
research or analysis. 

For the purposes of this Regulation, the following definitions shall apply: 

Article 3 
Definitions 

(1) 

"chemical" means a substance as defined in Directive 67/548/EEC, whether by itself 
or in a preparation, or a preparation, whether manufactured or obtained from nature, 
but  does  not  include  living  organisms,  which  belongs  to  either  of  the  following 
categories: 

(a) 

pesticides, including severely hazardous pesticide formulations;  

(b) 

industrial chemicals; 

(2) 

"preparation" means a mixture or a solution composed of two or more substances;  

(3) 

"article"  means  a  finished  product  containing  or  including  a  chemical,  the  use  of 
which  has  been  banned  or  severely  restricted  by  Community  legislation  in  that 
particular product;  

(4) 

"pesticides" means chemicals in either of the following sub-categories:  

(a) 

pesticides 
used 
Council Directive 91/414/EEC29 ; 

plant 

as 

protection 

products 

as 

covered 

by 

(b)  other  pesticides,  such  as  biocidal  products  under  Directive  98/8/EC  of  the 
the  Council30  and  such  as  disinfectants, 
European Parliament  and  of 
insecticides  and  parasiticides  under  Directive  2001/82/EC  and  Directive 
2001/83/EC; 

(5) 

"industrial chemicals" means chemicals in either of the following sub-categories: 

(a) 

chemicals for use by professionals;  

(b) 

chemicals for use by the public; 

26 
27 
28 
29 
30 

OJ L 106, 17.4.2001, p. 1.  
OJ L 311, 28.11.2001, p. 67. 
OJ L 311, 28.11.2001, p. 1. 
OJ L 230, 19.8.1991, p. 1. 
OJ L 123, 24.4.1998, p. 1. 

EN 

18 

   EN 

 
                                                                                                                                                                  
(6) 

(7) 

"chemical  subject  to  export  notification"  means  any  chemical  that  is  banned  or 
severely  restricted  within  the  Community  within  one  or  more  categories  or 
sub-categories, and any chemical that is subject to the PIC procedure listed in Part 1 
of Annex I;  

"chemical  qualifying  for  PIC  notification"  means  any  chemical  that  is  banned  or 
severely  restricted  within  the  Community  or  a  Member  State  within  one  or  more 
categories. Chemicals banned or severely restricted in the Community within one or 
more categories are listed in Part 2 of Annex I; 

(8) 

"chemical subject to the PIC procedure" means any chemical listed in Annex III to 
the Convention and in Part 3 of Annex I to this Regulation; 

(9) 

"banned chemical" means either of the following: 

(a) 

(b) 

a  chemical  all  uses  of  which  within  one  or  more  categories  or  sub-categories 
have been prohibited by final regulatory action by the Community, in order to 
protect human health or the environment;  

a  chemical  that  has  been  refused  approval  for  first-time  use  or  has  been 
withdrawn  by  industry  either  from  the  Community  market  or  from  further 
consideration in a notification, registration or approval process and where there 
is  evidence  that  the  chemical  raises  concerns  for  human  health  or  the 
environment;  

(10)  "severely restricted chemical" means either of the following: 

(a) 

(b) 

a  chemical,  virtually  all  use  of  which  within  one  or  more  categories  or  sub-
categories  has  been  prohibited  by  final  regulatory  action  in  order  to  protect 
human  health  or  the  environment,  but  for  which  certain  specific  uses  remain 
allowed;  

a  chemical  that  has,  for  virtually  all  use,  been  refused  for  approval  or  been 
withdrawn  by  industry  either  from  the  Community  market  or  from  further 
consideration  in  a  notification,  registration  or  approval  process,  and  where 
there  is  evidence  that  the  chemical  raises  concern  for  human  health  or  the 
environment;  

(11)  "chemical banned or severely restricted by a Member State" means any chemical that 
is banned or severely restricted by national regulatory action of a Member State; 

(12)  "final  regulatory  action"  means  a  legislative  act,  the  purpose  of  which  is  to  ban  or 

severely restrict a chemical; 

(13)  "severely hazardous pesticide formulation" means a chemical formulated for use as a 
pesticide  that  produces  severe  health  or  environmental  effects  observable  within  a 
short period of time after single or multiple exposure, under conditions of use; 

(14)  "export" means the following: 

(a) 

the  permanent  or  temporary  export  of  a  chemical  meeting  the  conditions  of 
Article 23(2) of the Treaty;  

EN 

19 

   EN 

 
(b) 

the re-export of a chemical not meeting the conditions of Article 23(2) of the 
Treaty which is placed under a customs procedure other than transit procedure; 

(15)  "import"  means  the  physical  introduction  into  the  customs  territory  of  the 
Community of a chemical that is placed under a customs procedure other than transit 
procedure; 

(16)  "exporter" means any of the following persons, whether natural or legal: 

(a) 

the  person  on  whose  behalf  an  export  declaration  is  made,  that  is  to  say  the 
person  who,  at  the  time  when  the  declaration  is  accepted,  holds  the  contract 
with  the  consignee  in  a  Party  or  other  country  and  has  the  power  for 
determining  the  sending  of  the  chemical  out  of  the  customs  territory  of  the 
Community; 

(b)  where  no  export  contract  has  been  concluded  or  where  the  holder  of  the 
contract  does  not  act  on  its  own  behalf,  the  person  who  has  the  power  for 
determining  the  sending  of  the  chemical  out  of  the  customs  territory  of  the 
Community;  

(c)  where  the  benefit  of  a  right  to  dispose  of  the  chemical  belongs  to  a  person 
established  outside  the  Community  pursuant  to  the  contract  on  which  the 
export is based, the contracting party established in the Community; 

(17)  "importer"  means  any  natural  or  legal  person  who  at  the  time  of  import  into  the 

customs territory of the Community is the consignee for the chemical; 

(18)  "Party  to  the  Convention"  or  "Party"  means  a  State  or  a  Regional  economic 
integration  organisation  that  has  consented  to  be  bound  by  the  Convention  and  for 
which the Convention is in force;  

(19)  "other country" means any country that is not a Party; 

Article 4 
Designated National Authorities 

Each Member State shall designate the authority or authorities, hereinafter the "Designated National 
Authority"  or  "Designated  National  Authorities",  to  act  for  the  performance  of  the  administrative 
functions required by this Regulation. 

It  shall  inform  the  Commission  of  such  designation  at  the  latest  three  months  after  the  entry  into 
force of this Regulation. 

Article 5 
Participation of the Community in the Convention 

1. 

The participation of the Community in the Convention shall be a joint responsibility of the 
Commission  and  the  Member  States  in  particular  for  technical  assistance,  information 
exchange and matters relating to dispute settlement, participation in subsidiary bodies and 
voting. 

EN 

20 

   EN 

 
2. 

As  far  as  the  participation  of  the  Community  in  the  Convention  is  concerned,  for  the 
administrative  functions  of  the  Convention  with  reference  to  the  PIC  procedure  and  the 
export notification, the Commission shall act as a common designated authority on behalf 
of  all  the  Designated  National Authorities  in  close  cooperation  and  consultation  with  the 
Designated National Authorities of the Member States. 

The Commission shall in particular, be responsible for the following: 

(a) 

(b) 

(c) 

the  transmission  of  Community  export  notifications  to  Parties  and  other  countries 
pursuant to Article 7; 

the submission to the Secretariat of the Convention, hereinafter “the Secretariat”, of 
notifications of relevant final regulatory actions pursuant to Article 10; 

the transmission of information about other final regulatory actions not qualifying for 
PIC notification in accordance with Article 11; 

(d) 

the receiving of information from the Secretariat more generally. 

The Commission shall also provide the Secretariat with Community import responses for 
chemicals subject to the PIC procedure pursuant to Article 12. 

In addition, the Commission shall coordinate the Community input on all technical issues 
related to any of the following: 

(a) 

the Convention; 

(b) 

(c) 

the  preparation  of  the  Conference  of  the  Parties  established  by  Article  18  of  the 
Convention, hereinafter “the Conference of the Parties”; 

the Chemical Review Committee established in accordance with Article 18(6) of the 
Convention, hereinafter “the Chemical Review Committee”; 

(d)  other subsidiary bodies.  

A network of Member State rapporteurs shall be established, as appropriate, to deal with 
the preparation of technical documents such as Decision Guidance Documents as referred 
to in Article 7(3) of the Convention, hereinafter “ Decision Guidance Document” . 

3. 

The  Commission  and  the  Member  States  shall  take  the  necessary  initiatives  to  ensure 
appropriate  representation  of  the  Community  in  the  various  bodies  implementing  the 
Convention.  

Article 6 
Chemicals subject to export notification, qualifying for PIC notification, and subject to the PIC 
procedure 

1. 

2. 

EN 

The chemicals covered by the provisions of this Regulation relating to export notification, 
PIC notification and the PIC procedure respectively shall be as listed in Annex I. 

Chemicals in Annex I shall be assignable to one or more of three groups of chemicals, set 
out respectively as Parts 1, 2 and 3 of Annex I. 

21 

   EN 

 
3. 

1. 

2. 

The chemicals listed in Part 1 of that Annex shall be subject to export notification as laid 
down in Article 7, with detailed information being given on the identity of the substance, 
on the use category and/or sub-category subject to restriction, the type of restriction and, 
where appropriate, additional information, in particular on exemptions to requirements for 
export notification. 

The chemicals listed in Part 2 of that Annex shall, in addition to being subject to the export 
notification procedure under Article 7, qualify for the PIC notification procedure laid down 
in Article 10, with detailed information being given on the identity of the substance and on 
the use category. 

The chemicals listed in Part 3 of that Annex shall be subject to the PIC procedure with the 
use  category  being  given  and,  where  appropriate,  additional  information,  in  particular  on 
any requirements for export notification. 

The  lists  referred  to  in  paragraph  2  shall  be  made  available  to  the  public  by  electronic 
means. 

Article 7 
Export Notifications forwarded to Parties and other countries 

In  the  case  of  substances  listed  in  Part  1  of  Annex  I  or  preparations  containing  such 
substances  in  a  concentration  that  could  to  trigger  labelling  obligations  under  Directive 
1999/45/EC  irrespective  of  the  presence  of  any  other  substances,  paragraphs  2  to  8  shall 
apply. 

When  an  exporter  is  due  to  export  a  chemical  as  referred  to  in  paragraph  1  from  the 
Community to a Party or other country for the first time following the date as from which 
it  becomes  subject  to  this  Regulation,  the  exporter  shall  notify  the  Designated  National 
Authority of the Member State in which he is established, no later than 30 days before the 
export  of  the  chemical  is  due  to  take  place.  Thereafter  the  exporter  shall  notify  the  first 
export of such chemical each calendar year to the Designated National Authority no later 
than  15  days  before  the  export  takes  place.  The  notification  shall  comply  with  the 
requirements set out in Annex III.  

The Designated National Authority shall check compliance of the information with Annex 
III and promptly forward the notification received from the exporter to the Commission.  

The  Commission  shall  take  the  necessary  measures  to  ensure  that  the  appropriate 
authorities of the importing Party or other country receive notification no later than 15 days 
prior  to  the  first  intended  export  of  the  chemical  and  thereafter  before  the  first  export  in 
any  subsequent  calendar  year.  This  shall  apply  regardless  of  the  expected  use  of  the 
chemical in the importing Party or other country. 

Each export notification shall be registered and assigned a reference number in a database 
at  the  Commission  and  an  updated  list  of  the  chemicals  concerned  and  the  importing 
Parties and other countries for each calendar year shall be kept available to the public, and 
distributed to the Designated National Authorities of the Member States as appropriate. 

3. 

If  the  Commission  does  not  receive  from  the  importing  Party  or  other  country  an 
acknowledgement  of  receipt  of  the  first  export  notification  made  after  the  chemical  is 

EN 

22 

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included in the Part 1 of Annex I within 30 days of the dispatch of the notification, it shall 
submit a second notification. The Commission shall make reasonable efforts to ensure that 
the  appropriate  authority  in  the  importing  Party  or  other  country  receives  the  second 
notification. 

A new export notification as provided for in paragraph 2 shall be given for exports which 
take place subsequent to changes to Community legislation concerning the marketing, use 
or  labelling  of  substances  in  question  or  whenever  the  composition  of  the  preparation  in 
question changes so that the labelling of such preparation is altered. The new notification 
shall  comply  with  the  requirements  set  out  in  Annex  III  and  shall  indicate  that  it  is  a 
revision of a previous notification. 

Where 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  other  country,  the 
requirements of paragraphs 2, 3 and 4 may be waived wholly or partly at the discretion of 
the Designated National Authority of the exporting Member State, in consultation with the 
Commission. 

The obligations set out in paragraphs 2, 3 and 4 shall cease when the following conditions 
are fulfilled: 

(a) 

the chemical has become a chemical subject to the PIC procedure;  

(b) 

the  importing  country  being  a  Party  to  the  Convention  has  provided  a  response  in 
accordance  with  Article  10(2)  of  the  Convention  to  the  Secretariat  whether  to 
consent or not to consent to import of the chemical;  

(c) 

the  Commission  has  been  informed  about  the  response  by  the  Secretariat  and  has 
forwarded that information to Member States. 

The  first  subparagraph  shall  not  apply  where  the  importing  country  being  Party  to  the 
Convention  explicitly  requires  continued  export  notification  by  exporting  Parties,  for 
example through its import decision or otherwise. 

The  obligations  set  out  in  paragraphs  2,  3  and  4  shall  also  cease  when  the  following 
conditions are fulfilled: 

(a) 

(b) 

the  appropriate  authority  of  the  importing  Party  or  other  country  has  waived  the 
requirement to be notified before the export of the chemical;  

the  Commission  has  received  the  information  from  the  Secretariat  or  from  the 
appropriate authority of the importing Party or other country and has forwarded it to 
Member States and made it available on the Internet. 

The Commission, the relevant Designated National Authorities of the Member States and 
the exporters shall provide importing Parties and other countries with available additional 
information on the exported chemicals, when requested. 

Member States may establish systems obliging the exporter to pay an administrative fee for 
each export notification made, corresponding to their costs in carrying out the procedures 
set out in paragraphs 2, 3 and 4.  

4. 

5. 

6. 

7. 

8. 

EN 

23 

   EN 

 
1. 

2. 

1. 

2. 

3. 

Article 8 
Export Notifications received from Parties and other countries 

Export notifications received by the Commission from the Designated National Authority 
of a Party or another  country  concerning the export to the Community of a chemical the 
manufacture,  use,  handling,  consumption,  transport  or  sale  of  which  is  subject  to 
prohibition  or  severe  restriction  under  that  Party's  or  other  country's  legislation  shall  be 
made available by electronic means through the database maintained by the Commission. 

The  Commission  shall  acknowledge  receipt  of  the  first  export  notification  received  for 
each chemical from each Party or other country. 

The Designated National Authority of the Member State receiving that import shall receive 
a copy of any notification received together with all available information. Other Member 
States shall be entitled to receive copies on request. 

Should  the  Designated  National  Authorities  of  the  Member  States  receive  any  export 
notifications  either  directly  or  indirectly  from  the  Designated  National  Authorities  of 
Parties  or  relevant  authorities  of  other  countries,  they  shall  immediately  forward  those 
notifications to the Commission together with all available information. 

Article 9 
Information on trade in chemicals 

Each exporter of substances listed in Annex I or preparations containing such substances in 
a  concentration  that  could  trigger  labelling  obligations  under  Directive  1999/45/EC 
irrespective of the presence of any other substances shall, during the first quarter of each 
year, inform the Designated National Authority of its Member State on the quantity of the 
chemical, as a substance and as contained in preparations, shipped to each Party or other 
country during the preceding year. That information shall be given together with a list of 
the names and addresses of each importer to which shipment took place during the same 
period. 

Each importer within the Community shall provide the same information for the quantities 
imported into the Community. 

Upon request from the Commission or the Designated National Authority, the exporter or 
importer shall provide any additional information relating to chemicals that is necessary to 
implement this Regulation. 

Each Member State shall provide the Commission each year with aggregated information 
in  accordance  with  Annex  IV.  The  Commission  shall  summarise  this  information  at 
Community level and shall make the non-confidential information publicly available on its 
database via the Internet. 

Article 10 
Participation in the notification of banned or severely restricted chemicals under the Convention 

1. 

The  Commission  shall  notify  the  Secretariat  in  writing  of  the  chemicals  that  qualify  for 
PIC notification. 

EN 

24 

   EN 

 
2. 

3. 

4. 

5. 

6. 

7. 

8. 

Where further chemicals qualify for PIC notification and are added to Part 2 of Annex I, 
the Commission shall notify the Secretariat. The notification shall be submitted as soon as 
possible  after  adoption  of  the  relevant  final  Community  regulatory  action  banning  or 
severely restricting the chemical, and no later than ninety days after the date on which the 
final regulatory action is required to be applied. 

The notification shall provide all relevant information as required in Annex II. 

In determining priorities for notifications, the Commission shall take into account whether 
the  chemical  is  already  listed  in  Part  3  of  Annex  I,  the  extent  to  which  the  information 
requirements laid down in Annex II can be met, and the severity of the risks presented by 
the chemical, in particular for developing countries. 

When a chemical qualifies for PIC notification, but the information is insufficient to meet 
the requirements of Annex II, identified exporters or importers shall, upon request by the 
Commission, provide all relevant information available to them, including that from other 
national or international chemical control programmes. 

The  Commission  shall  notify  the  Secretariat  in  writing  when  a  final  regulatory  action 
notified under paragraphs 1 or 2 is amended as soon as possible after adoption of the new 
final  regulatory  action,  and  no  later  than  60  days  after  the  date  on  which  the  new  final 
regulatory action is required to be applied. 

It shall provide all relevant information that was not available at the time when the initial 
notification was made under paragraphs 1 or 2 respectively. 

Upon  request  from  any  Party  or  from  the  Secretariat,  the  Commission  shall  provide 
additional information on the chemical or on the regulatory action, as far as practicable. 

The Member States shall, upon request, assist the Commission as necessary in compiling 
the information. 

The  Commission  shall  forward  immediately  to  the  Member  States  information  that  it 
receives from the Secretariat regarding chemicals notified as banned or severely restricted 
by other Parties. 

Where appropriate the Commission shall evaluate, in close cooperation with the Member 
States,  the  need  to  propose  measures  at  Community  level  in  order  to  prevent  any 
unacceptable risks for human health and the environment within the Community.  

Where  a  Member  State  takes  national  regulatory  action  in  accordance  with  the  relevant 
Community  legislation  to  ban  or  severely  restrict  a  chemical,  it  shall  provide  the 
Commission  with  relevant  information.  The  Commission  shall  make  that  information 
available to the Member States. Within four weeks Member States may send comments on 
a possible PIC notification, including in particular relevant information about their national 
regulatory position in respect of the chemical, to the Commission and the Member State, 
which  submitted  a  national  regulatory  action.  After  consideration  of  the  comments  the 
submitting Member State informs the Commission whether the latter shall: 

– 

– 

notify the Secretariat, pursuant to this Article; or 

provide the information to the Secretariat, pursuant to Article 11. 

EN 

25 

   EN 

 
Article 11 
Information to be transmitted to the Secretariat about banned or severely restricted chemicals not 
qualifying for PIC notification 

When  a  chemical  is  listed  only  in  Part  1  of  Annex  I  or  following  receipt  of  information  from  a 
Member  State  for  the  purposes  of  Article  10(8)  second  indent  the  Commission  shall  provide  the 
Secretariat  with  information  about the  relevant  regulatory  actions,  so  that  this  information  can  be 
disseminated to other Parties to the Convention as appropriate. 

Article 12 
Obligations in relation to imports of chemicals 

1. 

The Commission shall forward immediately to the Member States any Decision Guidance 
Documents which it receives from the Secretariat. 

The  Commission  shall,  in  accordance  with  the  advisory  procedure  referred  to  in  Article 
24(2), take an import decision, in the form of a final or interim import response on behalf 
of the Community, concerning the future import of the chemical concerned. . It shall then 
communicate  the  decision  to  the  Secretariat  as  soon  as  possible,  and  no  later  than  nine 
months after the date of dispatch of the Decision Guidance Document by the Secretariat. 

Where  a  chemical  is  subject  to  additional  or  amended  restrictions  under  Community 
legislation,  the  Commission  shall  revise  the  import  decision  in  accordance  with  the 
advisory  procedure  referred  to  in  Article  24(2)  and  communicate  the  revised  import 
decision to the Secretariat. 

In the case of a chemical banned or severely restricted  by  the  legislation  of  one  or  more 
Member States,  the  Commission  shall,  at  the  written  request  of  the  Member  States 
concerned, take the information into account in its import decision. 

An import decision under  paragraph  1 shall relate  to the category  or categories specified 
for the chemical in the Decision Guidance Document.  

When communicating the import decision to the Secretariat, the Commission shall provide 
a description of the legislative or administrative measure upon which it is based. 

Each  Designated  National  Authority  within  the  Community  shall  make  the  import 
decisions  under  paragraph  1  available  to  those  concerned  within  its  competence,  in 
accordance with its legislative or administrative measures. 

Where  appropriate,  the  Commission  shall  evaluate,  in  close  cooperation  with  the 
Member States, the need to propose measures at Community level in order to prevent any 
unacceptable  risks  for  human  health  and  the  environment  within  the  Community,  taking 
into account the information contained in the Decision Guidance Document.  

Article13 
Obligations in relation to exports of chemicals other than export notification requirements 

The Commission shall forward immediately to the Member States and European industry 
associations information which it receives, whether in the form of circulars or otherwise, 
from the Secretariat regarding chemicals subject to the PIC procedure and the decisions of 

2. 

3. 

4. 

5. 

6. 

1. 

EN 

26 

   EN 

 
2. 

3. 

4. 

5. 

6. 

importing  Parties  regarding  import  conditions  on  these  chemicals.  It  shall  also  forward 
immediately  to  the  Member States  information  on  any  cases  of  failure  to  transmit  a 
response.  The  Commission  shall  keep  all  information  regarding  import  decisions,  which 
will each be assigned a reference number, available in its database, which will be publicly 
available on the Internet, and provide anyone with the information upon request. 

For  each  chemical  listed  in  Annex  I  the  Commission  shall  assign  a  classification  in  the 
European Community's Combined Nomenclature. These classifications shall be revised as 
necessary  in  the  light  of  any  changes  made  in  the  World  Customs  Organisation's 
Harmonised  System  nomenclature  or 
the  European  Community's  Combined 
in 
Nomenclature for the chemicals concerned. 

Each Member State shall communicate the responses forwarded by the Commission under 
paragraph 1 to those concerned within its jurisdiction. 

Exporters  shall  comply  with  decisions  in  each  import  response  no  later  than  six  months 
after the Secretariat has first informed the Commission of such response under paragraph 
1. 

The  Commission  and  the  Member  States  shall  advise  and  assist  importing  Parties,  upon 
request and as appropriate, to obtain further information to help them to make a response to 
the Secretariat concerning import of a given chemical. 

Substances listed in the Parts 2 or 3 of Annex I or preparations containing such substances 
in  a  concentration  that  could  trigger  labelling  obligations  under  Directive  1999/45/EC 
irrespective of the presence of any other substances shall not be exported unless either of 
the following conditions is fulfilled: 

(a) 

explicit consent to the import into the third country concerned has been sought and 
received  by  the  exporter  through  his  Designated  National  Authority  via  the 
Commission  and  the  Designated  National  Authority  of  the  importing  Party  or  an 
appropriate authority in an importing other country;  

(b) 

in the case of chemicals listed in Part 3 of Annex I, the latest circular issued by the 
Secretariat  pursuant  to  paragraph  1  indicates  that  the  importing  Party  has  given 
consent to import. 

In the case of chemicals listed in part 2 of Annex I that are for export to OECD countries, 
the  Designated  National  Authority  of  the  exporter  may,  in  consultation  with  the 
Commission,  decide  that  no  explicit  consent  is  required  if  the  chemical,  at  the  time  of 
importation into the OECD country concerned, is licensed, registered or authorised or that 
it has recently been used in, or imported into, that OECD country and no regulatory action 
has been taken to prohibit its use. 

Where  explicit  consent  has  been  sought  pursuant  to  point  (a),  if  the  Commission  or  the 
Designated  National  Authority  of  the  exporter  has  not  received  a  response  to  its  request 
within 30 days, the Commission shall send a reminder. Where appropriate, if there is still 
no  response  within  a  further  30  days,  the  Commission  may  send  further  reminders  as 
necessary. 

7. 

The  Designated  National  Authority  of  the  exporter  may,  in  consultation  with  the 
Commission,  decide  that  the  export  may  proceed  if,  after  all  reasonable  efforts,  no 

EN 

27 

   EN 

 
response  to  a  request  for  explicit  consent  pursuant  to  paragraph  6(a)  has  been  received 
within either of the following time-limits:  

(a) 

60  days,  where  there  is  evidence  from  official  sources  in  the  importing  Party  or 
importing  other  country  that  the  chemical,  at  the  time  of  importation,  is  licensed, 
registered  or  authorised  or  that  it  has  recently  been  used  in,  or  imported  into,  the 
importing Party or importing other country and no regulatory action has been taken 
to prohibit its use;  

(b)  90 days, in all other cases. 

8. 

The validity of each explicit consent obtained pursuant to paragraph 6(a) or waiver granted 
pursuant  to  paragraph  7  shall  be  subject  to  periodic  review  by  the  Commission  in 
consultation with the Member States concerned as follows: 

(a) 

for each explicit consent obtained pursuant to paragraph 6(a) a new explicit consent 
shall be required by the end of the third calendar year after the consent  was  given, 
unless the terms of that consent require otherwise; 

(b)  unless  a  response  to  a  request  has  been  received  in  the  meantime,  each  waiver 
granted  pursuant  to  paragraph  7(a)  shall  be  for  a  maximum  period  of  two  calendar 
years, upon expiry of which explicit consent shall be required;  

(c) 

unless  a  response  to  a  request  has  been  received  in  the  meantime,  each  waiver 
granted  pursuant  to  paragraph  7(b)  shall  be  for  a  maximum  period  of  12  months, 
upon expiry of which explicit consent shall be required.  

In  the  cases  referred  to  in  points  (a)  and  (b),  exports  may  however  continue  beyond  the 
expiry of the relevant period pending a response to a new request for explicit consent. 

In  the  case  referred  to  in  point  (c),  exports  may  not  continue  beyond  the  expiry  of  the 
relevant period unless explicit consent is obtained or the conditions of paragraph 7(a) are 
met following a new request for explicit consent. 

All new requests shall be channelled through the Commission. 

9. 

10. 

11. 

The  Commission  shall  register  all  requests  for  explicit  consent,  responses  obtained  and 
waivers granted in its database. Each explicit consent obtained or waived shall be assigned 
a  reference  number  and  will  be  listed  with  all  relevant  information  about  any  conditions 
attached,  validity  dates,  etc.  The  non-confidential  information  shall  be  publicly  available 
on the Internet. 

No  chemical  shall  be  exported  later  than  six  months  before  its  expiry  date,  when  such  a 
date exists or can be inferred from the production date, unless the intrinsic properties of the 
chemical  render  this  impracticable.  In  particular,  in  the  case  of  pesticides  exporters  shall 
ensure that the size and packaging of pesticide containers is optimised so as to minimise 
the risks of creating obsolete stocks. 

When  exporting  pesticides,  exporters  shall  ensure  that  the  label  contains  specific 
information about storage conditions and storage stability under the climatic conditions of 
the  importing  Party  or  other  country.  In  addition,  they  shall  ensure  that  the  exported 
pesticides comply with the purity specification established by Community legislation. 

EN 

28 

   EN 

 
1. 

2. 

1. 

2. 

3. 

4. 

1. 

2. 

Article 14 
Controls on export of certain chemicals and articles containing chemicals 

Articles  containing  substances  listed  in  Parts  2  or  3  of  Annex  I  in  unreacted  form  or 
preparations  containing  such  substances  in  a  concentration  that  could  trigger  labelling 
obligations  under  Directive  1999/45/EC  irrespective  of  the  presence  of  any  other 
substances, shall be subject to the export notification procedure laid down in Article 7. 

Chemicals and articles the use of which is prohibited in the Community for the protection 
of human health or the environment, as listed in Annex V, shall not be exported. 

Article 15 
Information on transit movements 

Parties to the Convention requiring information on transit movements of chemicals subject 
to  the  PIC  procedure,  together  with  the  information  requested  by  each  Party  to  the 
Convention through the Secretariat, shall be as listed in Annex VI. 

When a chemical listed in Part 3 of Annex I is transported through the territory of a Party 
to the Convention listed in Annex VI, the exporter shall, as far as practicable, provide the 
Designated  National  Authority  of  the  Member  State  in  which  he  is  established  with  the 
information required by the Party to the Convention in accordance with Annex VI no later 
than thirty days before the first transit takes place and no later than eight days before each 
subsequent transit movement. 

The Designated National Authority of the Member State shall forward to the Commission 
the information received from the exporter under paragraph 2 together with any available 
additional information. 

The  Commission  shall  forward  the  information  received  under  paragraph  3  to  the 
Designated  National  Authorities  of  Parties  to  the  Convention  which  requested  such 
information, together with any available additional information, no later than fifteen days 
before first transit movement and prior to any subsequent transit movement. 

Article 16 
Information to accompany exported chemicals 

Chemicals that are intended for export shall be subject to the measures on packaging and 
labelling  established  in,  or  pursuant  to,  Directive  67/548/EEC,  Directive 1999/45/EC, 
Directive 91/414/EEC and Directive 98/8/EC, or any other specific Community legislation.  

The  first  subparagraph  shall  be  without  prejudice  to  any  specific  requirements  of  the 
importing Party or other country taking into account relevant international standards. 

Where  appropriate,  the  expiry  date  and  the  production  date  of  chemicals  referred  to  in 
paragraph 1  or  listed  in  Annex  I  shall  be  indicated  on  the  label,  and  if  necessary  such 
expiry dates shall be given for different climate zones. 

EN 

29 

   EN 

 
3. 

4. 

A  safety  data  sheet  in  accordance  with  Commission  Directive  91/155/EEC31  shall 
accompany chemicals referred to in paragraph 1, when exported. The exporter shall send 
such a safety data sheet to each importer. 

The  information  on  the  label  and  on  the  safety  data  sheet  shall  as  far  as  practicable  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. 

Article 17 
Obligations of the authorities of the Member States for controlling import and export 

1. 

Each Member State shall designate authorities such as customs authorities that shall have 
the responsibility of controlling the import and export of chemicals listed in Annex I. 

The  Commission  and  the  Member  States  shall  act  in  a  targeted  and  coordinated  way  in 
controlling compliance of exporters with this Regulation. 

Each Member State shall, in its regular reports on the operation of procedures pursuant to 
Article 21(1), include details of the activities of its authorities in this regard. 

2. 

Exporters shall provide in box 44 of the Single Administrative Documents setting out their 
export declarations the applicable reference numbers referred to in Articles 7(2) or 13(1) or 
13(9) as appropriate confirming compliance with the obligations to which they relate. 

Article 18 
Penalties 

Member  States  shall  determine  the  penalties  applicable  to  infringements  of  the  provisions  of  this 
Regulation  and  take  all  necessary  measures  to  ensure  correct  implementation  of  these  provisions. 
The penalties must be effective, proportional and dissuasive. If they have not already done so prior 
to adoption of this Regulation, Member States shall notify these measures to the Commission not 
later than twelve months after the adoption. They shall also notify any further modifications as soon 
as possible after their adoption. 

Article 19 
Information exchange 

1. 

The  Commission  and  the  Member  States  shall,  as  appropriate,  facilitate  the  provision  of 
scientific, technical, economic and legal information concerning chemicals subject to this 
Regulation, including toxicological, ecotoxicological and safety information. 

The  Commission,  with  the  support  of  the  Member  States  as  necessary,  shall,  as 
appropriate, ensure: 

(a) 

the provision of publicly available information on regulatory actions relevant to the 
objectives of the Convention; and 

31 

OJ L 76, 22.3.1991, p. 35. 

EN 

30 

   EN 

 
                                                 
(b) 

the  provision  of  information  to  Parties  and  other  countries  directly  or  through  the 
Secretariat  on  those  actions  which  substantially  restrict  one  or  more  uses  of  a 
chemical. 

2. 

3. 

The  Commission  and  the  Member  States  shall  protect  any  confidential  information 
received from another Party or another country as mutually agreed. 

As regards the transmission of information under this Regulation, and without prejudice to 
Council Directive 90/313/EEC32, the following shall not be regarded as confidential: 

(a) 

the information specified in Annex II and Annex III;  

(b) 

the information contained in safety data sheets referred to in Article 16(3); 

(c) 

the expiry date of the chemical; 

(d) 

the production date of the chemical; 

(e) 

information on precautionary measures, including hazard classification, the nature of 
the risk and the relevant safety advice;  

(f) 

the summary results of the toxicological and ecotoxicological tests. 

A  compilation  of  the  information  transmitted  shall  be  prepared  regularly  by  the 
Commission on the basis of the contributions of Member States. 

Article 20 
Technical assistance 

The Commission and the Designated National Authorities of the Member States shall, taking into 
account in particular the needs of developing countries and countries with economies in transition, 
cooperate  in  promoting  technical  assistance,  including  training,  for  the  development  of  the 
infrastructure,  the  capacity  and  the  expertise  necessary  to  manage  chemicals  properly  throughout 
their life cycle. 

In particular, and with a view  to enabling these countries to implement  the Convention, technical 
assistance  shall  be  promoted  by  providing  technical  information  on  chemicals,  by  promoting  the 
exchange of experts, by giving support for the establishment or maintenance of Designated National 
Authorities  and  by  providing  technical  expertise  for  the  identification  of  hazardous  pesticides 
formulations and for the preparation of notifications to the Secretariat. 

The Commission and the Member States should actively participate in the Information Network on 
Capacity  Building  set  up  by  the  Intergovernmental  Forum  on  Chemical  Safety,  by  providing 
information  on  the  projects  they  are  supporting  or  financing  to  improve  the  management  of 
chemicals in developing countries and countries with economies in transition. 

The Commission and the Member States shall also consider giving support to Non-Governmental 
Organisations. 

32 

OJ L 158, 23.6.1990, p. 56. 

EN 

31 

   EN 

 
                                                 
1. 

2. 

3. 

1. 

2. 

3. 

4. 

Article 21 
Monitoring and Reporting 

Member States shall regularly forward to the Commission information on the operation of 
the procedures provided for in this Regulation, including customs controls, infringements, 
penalties, and remedial action. 

The  Commission  shall  regularly  compile  a  report  on  the  performance  of  the  functions 
provided  for  in  this  Regulation  for  which  it  is  responsible  and  shall  integrate  it  in  a 
synthesis  report  compiling  the  information  provided  by  the  Member  States  under 
paragraph  1.  A  summary  of  the  report,  which  will  be  published  on  the  Internet,  shall  be 
forwarded to the European Parliament and to the Council. 

As  regards  the  information  supplied  pursuant  to  paragraphs  1  and  2,  the  Member States 
and the Commission shall comply with relevant obligations to protect the confidentiality of 
data and ownership. 

Article 22 
Updating Annexes 

The list of chemicals in Annex I shall be reviewed by the Commission at least every year, 
on the basis of developments under Community law and under the Convention. 

In determining whether a final regulatory action at Community level constitutes a ban or a 
severe  restriction,  the  effect  of  that  action  shall  be  assessed  at  the  level  of  the  sub-
categories  within  the  categories  "pesticides"  and  "industrial  chemicals".  If  the  regulatory 
action  bans  or  severely  restricts  a  chemical  in  any  one  of  the  sub-categories  it  shall  be 
included in the Part 1 of Annex I. 

In determining whether a final regulatory action at Community level constitutes a ban or a 
severe  restriction  such  that  the  chemical  concerned  qualifies  for  PIC  notification  under 
Article  10,  the  effect  of  that  action  shall  be  assessed  at  the  level  of  the  categories 
"pesticides"  and  "industrial  chemicals".  If  the  regulatory  action  bans  or  severely  restricts 
the use of a chemical within either of the categories it shall also be included in Part 2 of 
Annex I. 

The Commission shall take a decision to include chemicals in Annex I, or to amend their 
entry where appropriate, without undue delay. 

Inclusion of a chemical in the Parts 1 or 2 of Annex I pursuant to paragraph 2 following 
regulatory  action  at  Community  level  shall  be  decided  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 24(3). 

Inclusion  of  a  chemical  that  is  subject  to  Regulation  (EC)  850/2004  of  the  European 
Parliament and of the Council33 in Annex V shall be subject to the same procedure. 

All  other  amendments  to  Annex  I,  including  modifications  to  existing  entries,  and 
amendments to Annexes II, III, IV and VI, and modifications to existing entries in Annex 
V, shall be adopted in accordance with the advisory procedure referred to in Article 24(2). 

33 

OJ L 158, 30.4.2004, p.7 

EN 

32 

   EN 

 
                                                 
Article 23 
Technical notes for guidance 

The Commission, in accordance with the advisory procedure referred to in Article 24(2), shall draw 
up technical notes for guidance to facilitate the day-to-day application of this Regulation. 

The  technical  notes  shall  be  published  in  the  "C"  series  of  the  Official  Journal  of  the 
European Union. 

Article 24 
Committee 

1. 

2. 

3. 

4. 

The  Commission  shall  be  assisted  by  the  committee  established  by  Article  29  of 
Directive 67/548/EEC. 

Where  reference  is  made  to  this  paragraph,  Article  3  and  Article  7  of  Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

Where reference is made to this paragraph, Article 5(a) (1) to (4) and Article 7 of Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The Committee shall adopt its rules of procedure. 

Article 25 
References to Regulation (EC) No 304/2003 

References to Regulation (EC) No 304/2003 shall be construed as references to this Regulation. 

Article 26 
Entry into force 

This  Regulation  shall  enter  into  force  on  the  day  following  that  of  its  publication  in  the  Official 
Journal of the European Union. 

Article 17(2), however, shall apply as from [1 November 2007]. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 
[…] 

For the Council 
The President 
[…] 

EN 

33 

   EN 

 
ANNEX I 

Part 1: List of chemicals subject to export notification procedure 

(Article 7) 

It  should  be  noted  that  where  chemicals  listed  in  this  part  of  the  Annex  are  subject  to  the  PIC 
procedure,  the  export  notification  obligations  set  out  in  Article  7(2),(3)  and(4)  shall  not  apply 
provided that the conditions laid down in points (b) and (c) of Article 7(6) have been fulfilled. Such 
chemicals, which are identified by the symbol # in the list below, are listed again in Part 3 of this 
Annex for ease of reference. 

It  should  also  be  noted  that  where  the  chemicals  listed  in  this  part  of  the  Annex  qualify  for  PIC 
notification because of the  nature of the Community's  final regulatory action, these chemicals are 
also listed in Part 2 of this Annex. Such chemicals are identified by the symbol + in the list below. 

CHEMICAL 

CAS No 

Einecs No 

CN Code 

Sub-
category* 

limi-

Use 
tation** 

Countries  for  which  no 
notification is required 

1,1,1-Trichloroethane 

71-55-6 

200-756-3 

2903 19 10 

i(2) 

b 

106-93-4 

203-444-5 

2903 30 36 

p(1)-p(2) 

b-b 

107-06-2 

203-458-1 

2903 15 00 

p(1)-p(2) 

b-b 

i(2) 

b 

10061-01-5 

233-195-8 

2903 29 00 

p(1)-p(2) 

b-b 

Please refer to PIC 
circular at 
www.pic.int/ 

Please refer to PIC 
circular at 
www.pic.int/ 

1,2-Dibromoethane 
(Ethylene dibromide)# 

1,2-Dichloroethane 
(ethylene dichloride)# 

Cis- 
1,3-
dichloropropene ((1Z)-
1,3-dichloroprop-1-
ene) 

2-aminobutane 

13952-84-6 

237-732-7 

2921 19 80 

p(1)-p(2) 

b-b 

2-Naphthylamine 
(naphthalen-2-amine) 
and its salts+ 

91-59-8,  553-
00-4,  612-52-
2 and others 

2,4,5-T  and  its  salts 
and esters# 

93-76-5 
others 

and 

202-080-4, 
209-030-0, 
210-313-6 
and others 

202-273-3, 
229-188-1 
and others 

2921 45 00  

i(1) 

i(2) 

b 

b 

2918 90 90 

p(1)-p(2) 

b-b 

4-Aminobiphenyl 
(biphenyl-4-amine) 
and its salts+ 

92-67-1, 
2113-61-3 and 
others 

202-177-1 
and others 

2921 49 80,  

i(1) 

i(2) 

4-Nitrobiphenyl+ 

92-93-3 

202-204-7 

2904 20 00  

i(1) 

i(2) 

b 

b 

b 

b 

Please refer to PIC 
circular at 
www.pic.int/ 

EN 

34 

   EN 

 
 
 
 
 
 
 
 
 
 
Acephate + 

Acifluorfen 

Aldicarb + 

Ametryn 

Amitraz + 

Arsenic compounds 

Asbestos Fibres+: 

Crocidolite# 
Amosite# 
Antophyllite# 
Actinolite# 
Tremolite# 
Chrysotile + 

Atrazine + 

30560-19-1 

250-241-2 

2930 90 70 

p(1)-p(2) 

b-b 

50594-66-6 

256-634-5 

2916 39 00 

p(1)-p(2) 

b-b 

116-06-3 

204-123-2 

2930 90 70 

p(1)-p(2) 

sr-b 

834-12-8 

212-634-7 

2933 69 80 

p(1)-p(2) 

b-b 

33089-61-1 

251-375-4 

2925 20 00 

p(1) 

1332-21-4 and 
others 
12001-28-4 
12172-73-5 
77536-67-5 
77536-66-4 
77536-68-6 
12001-29-5  or 
132207-32-0 

p(2) 

2524 00 00 
2524 00 00 
2524 00 00 
2524 00 00 
2524 00 00 
2524 00 00 

i 
i 
i  
i 
i 
i 

sr 

sr 

b 
b 
b 
b 
b 
b 

1912-24-9 

217-617-8 

2933 69 10 

p(1)-p(2) 

sr-b 

Azinphos-ethyl 

2642-71-9 

220-147-6 

2933 99 90 

p(1)-p(2) 

b-b 

Bensultap 

Benzene (1) 

17606-31-4 

2930 90 70 

p(1)-p(2) 

b-b 

71-43-2 

200-753-7 

2902 20 00 

i(2) 

sr  

Benzidine and its 
salts+ 

92-87-5, 
36341-27-2 
and others 

202-199-1, 
252-984-8 
and others 

2921 59 90  

i(1) – i(2)
i(2) 

sr – b 
b 

Please refer to PIC 
circular at 
www.pic.int/ 

Benzidine derivatives+ 

- 

- 

Binapacryl# 

485-31-4 

207-612-9 

2916 19 80  

p(1)  –p(2)
i(2) 

b-b 
b 

Please refer to PIC 
circular at 
www.pic.int/ 

Cadmium 
Compounds 

and 

its 

7440-43-9 and 
others 

231-152-8 
and others 

8107 
3206 30 00 
and others 

i(1) 

sr 

Calciferol 

Captafol# 

50-14-6 

200-014-9 

2936 29 90 

p(1) 

b 

2425-06-1 

219-363-3 

2930  90  70 

p(1) –p(2) 

b-b 

Carbon tetrachloride 

56-23-5 

200-262-8 

2903 14 00 

i(2) 

b 

Cartap 

15263-53-3 

2930 20 00 

p(1)-p(2) 

b-b 

Chinomethionat 

2439-01-2 

219-455-3 

2934 99 90 

p(1)-p(2) 

b-b 

Chlordimeform# 

6164-98-3 

228-200-5 

2925 20 00 

p(1) –p(2) 

b-b 

EN 

35 

Please refer to PIC 
circular at 
www.pic.int/ 

Please refer to PIC 
circular at 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
www.pic.int/ 

Please refer to PIC 
circular at 
www.pic.int/ 

Chlorfenapyr+ 

122453-73-0 

2933 99 90 

p(1) 

b 

Chlorfenvinphos 

470-90-6 

207-432-0 

2919 00 90 

p(1)-p(2) 

b-b 

Chlormephos 

24934-91-6 

246-538-1 

2930 90 70 

p(1)-p(2) 

b-b 

Chlorobenzilate# 

510-15-6 

208-110-2 

2918 19 80 

p(1)-p(2) 

b-b 

Chloroform 

Chlozolinate+ 

67-66-3 

200-663-8 

2903 13 00 

i(2) 

b 

84332-86-5 

282-714-4 

2934 99 90 

p(1)-p(2) 

b-b 

Cholecalciferol 

67-97-0 

200-673-2 

2936 29 90 

p(1) 

b 

Coumafuryl 

117-52-2 

204-195-5 

2932 29 85 

p(1)-p(2) 

b-b 

Creosote  and  Creosote 
related substances 

2707 91 00 

3807 00 90 

8001-58-9 
61789-28-4 
84650-04-4 
90640-84-9 
65996-91-0 
90640-80-5 
65996-85-2 
8021-39-4 
122384-78-5 

232-287-5 
263-047-8 
283-484-8 
292-605-3 
266-026-1 
292-602-7 
266-019-3 
232-419-1 
310-191-5  

i(2) 

b 

Crimidine 

Cyanazine 

535-89-7 

208-622-6 

2933 59 95 

p(1) 

b 

21725-46-2 

244-544-9 

2933 69 80 

p(1)-p(2) 

b-b 

Cyhalothrine 

68085-85-8 

268-450-2 

2926 90 95 

p(1) 

75113-37-0 

401-040-5 

2931 00 95 

i(1) 

b 

b 

(Di-µ-oxo-di-n-

DBB 
butylstannio-
hydroxyborane/ 
dioxastannaboretan-4-
ol) 

Dicofol  containing  < 
78%  p,p’-Dicofol  or  1 
g/kg of DDT and DDT 
related compounds+ 

Dinitro-ortho-cresol 
(DNOC)  and  its  salts 
(such  as  ammonium 
salt, potassium salt and 
sodium salt)# 

115-32-2 

204-082-0 

2906 29 00  

p(1)-p(2) 

b-b 

534-52-1 
2980-64-5 
5787-96-2 
2312-76-7 

208-601-1 
221-037-0 
- 
219-007-7 

2908 90 00 

p(1)-p(2) 

b-b 

Please refer to PIC 
circular at 
www.pic.int/ 

Dinobuton 

973-21-7 

213-546-1 

2920 90 10 

p(1)-p(2) 

b-b 

Dinoseb  and  its  salts  88-85-7 

and others 

201-861-7 
and others 

2908 90 00  
2915 39 90 

p(1)-p(2) 
i(2) 

b-b 
b 

Please refer to PIC 
circular at 

EN 

36 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and esters# 

Dinoterb+ 

Dustable powder 
formulations 
containing a 
combination of: 

Benomyl at or above 
7%, 

Carbofuran at or above 
10% 

and Thiram at or 
above 15% #  

Endosulfan+ 

Ethion 

Ethylene oxide 
(Oxirane)# 

Fenpropathrin 

Fenthion + 

1420-07-1 

215-813-8 

2908 90 00 

p(1) -p(2) 

b-b 

3808 90 90 

17804-35-2 

241-775-7 

2933 99 90 

p(1) 

1563-66-2 

216-353-0 

2932 99 85 

p(2) 

b 

b 

137-26-8 

205-286-2 

2930 30 00 

115-29-7 

204-079-4 

2920 90 85 

p(1) 

b 

563-12-2 

209-242-3 

2930 90 70 

p(1)-p(2) 

b-b 

75-21-8 

200-849-9 

2910 10 00  

p(1) 

b 

39515-41-8 

254-485-0 

2926 90 95 

p(1)-p(2) 

b-b 

55-38-9 

200-231-9 

2930 90 70 

p(1) 

sr 

Fentin acetate + 

900-95-8 

212-984-0 

2931 00 95 

p(1)-p(2) 

b-b 

Fentin hydroxide + 

76-87-9 

200-990-6 

2931 00 95 

p(1) -p(2) 

b-b 

Fenvalerate 

Ferbam 

51630-58-1 

257-326-3 

2926 90 95 

p(1) 

b 

14484-64-1 

238-484-2 

2930 20 00 

p(1) -p(2) 

b-b 

Fluoroacetamide# 

640-19-7 

211-363-1 

2924 19 00 

p(1) 

b 

Flurenol 

Furathiocarb 

HCH/Hexachlorocyclo
hexane (mixed 
isomers)# 

467-69-6 

207-397-1 

2918 19 80 

p(1)-p(2) 

b-b 

65907-30-4 

265-974-3 

2932 99 85 

p(1)-p(2) 

b-b 

608-73-1 

210-168-9 

2903 51 00  

p(1)-p(2) 

b-sr 

Hexachloroethane 

67-72-1 

200-666-4 

2903 19 80 

i(1) 

sr 

Hexazinone 

Iminoctadine 

51235-04-2 

257-074-4 

2933 69 80 

p(1)-p(2) 

b-b 

13516-27-3 

236-855-3 

2925 20 00 

p(1)-p(2) 

b-b 

www.pic.int/ 

Please refer to PIC 
circular at 
www.pic.int/ 

Please refer to PIC 
circular at 
www.pic.int/ 

Please refer to PIC 
circular at 
www.pic.int/ 

Please refer to PIC 
circular at 
www.pic.int/ 

EN 

37 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Isoxathion 

18854-01-8 

242-624-8 

2934 99 90 

p(1) 

b 

Lindane (γ-HCH) # 

58-89-9 

200-401-2 

2903 51 00 

p(1)-p(2) 

b-sr 

Please refer to PIC 
circular at 
www.pic.int/ 

123-33-1 

204-619-9 

2933 99 90 

p(1) 

b 

61167-10-0, 
51542-52-0, 
28330-26-9 

257-261-0, 
248-972-7 

2933 99 90 

10112-91-1, 
21908-53-2 
and others 

233-307-5, 
244-654-7 
and others 

2827 39 80, 
2825 90 50 
and others 

p(1)- p(2) 

b - sr 

Please refer to PIC 
circular at 
www.pic.int/ 

10265-92-6 

233-606-0 

2930 90 70 

p(2) 

b 

3808 10 40 

Please refer to PIC 
circular at 
www.pic.int/ 

(a)  Maleic  hydrazide, 
and its salts, other than 
choline, potassium and 
sodium salts; 

(b) Choline, potassium 
and  sodium  salts  of 
hydrazide 
maleic 
containing  more  than 
of 
1 mg/kg 
free 
hydrazine 
expressed 
on the basis of the acid 
equivalent 

Mercury compounds, 
including inorganic 
mercury compounds, 
alkyl mercury 
compounds and 
alkyloxyalkyl and aryl 
mercury compounds# 

Methamidophos 
(Soluble liquid 
formulations of the 
substance that 
exceed 600 g active 
ingredient/l) # 

Methidathion 

950-37-8 

213-449-4 

2934 99 90 

p(1)-p(2) 

b-b 

Methyl-parathion + 
# 

298-00-0 

206-050-1 

2920 10 00 

p(1)-p(2) 

b-b 

Metoxuron 

19937-59-8 

243-433-2 

2924 21 90 

p(1)-p(2) 

b-b 

Monocrotophos # 

6923-22-4 

230-042-7 

 2924 19 00 

p(1)-p(2) 

b-b 

Monolinuron 

1746-81-2 

217-129-5 

2928 00 90 

p(1) 

Monomethyl-dibromo-
diphenyl methane 
Tradename: DBBT+ 

99688-47-8 

401-210-1 

2903 69 90  

i(1) 

b 

b 

Please refer to PIC 
circular at 
www.pic.int/ 

Please refer to PIC 
circular at 
www.pic.int/ 

EN 

38 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Monomethyl-
Dichloro-Diphenyl 
methane; 
Tradename: Ugilec 
121 or Ugilec 21+ 

Monomethyl-
Tetrachlorodiphenyl 
methane; 
Tradename: 
141+ 

Ugilec 

Monuron 

Nitrofen+ 

Nonylphenols 
C6H4(OH)C9H19 + 

Nonylphenol 
ethoxylates 
(C2H4O)nC15H24O+ 

Octabromodiphenyl 
ether + 

Omethoate 

Parathion# 

- 

400-140-6 

2903 69 90 

i(1) – i(2) 

b - b 

76253-60-6 

278-404-3 

2903  69  90 

i(1) – i(2) 

b-b 

150-68-5 

205-766-1 

2924 21 90 

p(1) 

b 

1836-75-5 

217-406-0 

2909 30 90 

p(1)-p(2) 

b-b 

246-672-0, 

2907 13 00 

i(1) 

sr 

284-325-5 

234-284-4 

291-844-0 

203-199-4 

and others 

3402 13 00 

i(1) 
p(1)-p(2) 

Sr 
b-b 

25154-52-3 
(phenol, 
nonyl-), 
84852-15-3 
(phenol, 4-
nonyl-, 
branched) 
11066-49-2 
(isononylphen
ol), 
90481-04-2, 
(phenol, 
nonyl-, 
branched), 
104-40-5(p-
nonylphenol) 
and others 

9016-45-9, 
26027-38-3, 
68412-54-4, 
37205-87-1, 
127087-87-0 
and others 

32536-52-0 

251-087-9 

2909 30 38 

i(1) 

sr 

1113-02-6 

214-197-8 

2930 90 70 

p(1)-p(2) 

b-b 

56-38-2 

200-271-7 

2920 10 00 

p(1)-p(2) 

b-b 

Pebulate 

1114-71-2 

214-215-4 

2930 20 00 

p(1)-p(2) 

b-b 

Pentabromodiphenyl 
ether + 

32534-81-9 

251-084-2 

2909 30 31 

i(1) 

sr 

Pentachlorophenol  and 
its salts and esters# 

87-86-5 
others 

and 

201-778-6 
and others 

2908  10  00 
and others 

p(1)-p(2) 

b-sr 

Please refer to PIC 
circular at 
www.pic.int/ 

Please refer to PIC 
circular at 
www.pic.int/ 

EN 

39 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
to PIC circular at 
www.pic.int/ 

Please refer to PIC 
circular at 
www.pic.int/ 

Please refer to PIC 
circular at 
www.pic.int/ 

236-116-5 

 2924 19 00 

p(1)-p(2) 

b-b 

Please refer 

Permethrin 

52645-53-1 

258-067-9 

2916 20 00 

p(1) 

b 

Phosphamidon  
liquid 
(Soluble 
formulations  of 
the 
substance  that  exceed 
1000 g 
active 
ingredient/l) # 

Polybrominated 
biphenyls (PBB)# 

Polychlorinated 
terphenyls (PCT)# 

Propham 

Pyrazophos+ 

Quintozene+ 

Scilliroside 

Simazine + 

Strychnine 

Tecnazene+ 

Terbufos 

13171-21-6 
(mixture, 
(E)&(Z) 
isomers) 
23783-98-4 
((Z)-isomer) 
297-99-4 ((E)-
isomer) 

13654-09-6 
36355-01-8 
27858-07-7 
and others 

3808 10 40 

237-137-2 
252-994-2 
248- 696-7 

2903 69 90 
and others 

i(1)  

sr 

61788-33-8 

262-968-2 

2903 69 90 

i(1) 

122-42-9 

204-542-0 

2924 29 95 

p(1) 

b 

b 

13457-18-6 

236-656-1 

2933 59 95 

p(1) -p(2) 

b-b 

82-68-8 

201-435-0 

2904 90 85 

p(1) -p(2) 

b-b 

507-60-8 

208-077-4 

2938 90 90 

p(1) 

122-34-9 

204-535-2 

2933 69 10 

p(1) 

57-24-9 

200-319-7 

2939 99 00 

p(1) 

b 

sr 

b 

117-18-0 

204-178-2 

2904 90 85 

p(1) -p(2) 

b-b 

13071-79-9 

235-963-8 

2930 90 70 

p(1)-p(2) 

b-b 

Tetraethyl lead # 

78-00-2 

201-075-4 

2931 00 95 

i(1) 

sr 

Tetramethyl lead # 

75-74-1 

200-897-0 

2931 00 95 

i(1) 

sr 

Please refer to PIC 
circular at 
www.pic.int/ 

Please refer to PIC 
circular at 
www.pic.int/ 

Thallium sulphate 

7446-18-6 

231-201-3 

2833 29 90 

p(1) 

b 

Thiocyclam 

Triazophos 

Tridemorph 

Triorganostannic 
compounds+ 

Tris (2,3-
Dibromopropyl) 

31895-22-4 

250-859-2 

2934 99 90 

p(1)-p(2) 

b-b 

24017-47-8 

245-986-5 

2933 99 90 

p(1)-p(2) 

b-b 

24602-86-6 

246-347-3 

2934 99 90 

p(1)-p(2) 

b-b 

- 

- 

2931 00 95 
and others 

p(2) 
i(2) 

126-72-7 

204-799-9 

2919 00 90 

i(1) 

Sr 
sr 

sr 

EN 

40 

Please  refer  to  PIC 
at 
circular 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
545-55-1 

208-892-5 

2933 99 90 

i(1) 

sr 

www.pic.int/ 

Phosphate# 

Tris-aziridinyl-
phosphinoxide 
(1,1’,1’’-
phosphoryltriaziridine)
+ 

Vamidothion 

2275-23-2 

218-894-8 

2930 90 70 

p(1)-p(2) 

b-b  

Zineb 

* 

** 

12122-67-7 

235-180-1 

2930 20 00 

p(1) 

b 

Sub-  Category:  p(1)  –  pesticide  in  the  group  of  plant  protection  products,  p(2)  –  other 
pesticide  including  biocides.  i(1)  -  industrial  chemical  for  professional  use  and  i(2)  – 
industrial chemical for public use. 

Use  limitation:  sr  -  severe  restriction,  b  –  ban  (for  the  sub-category  or  sub-categories 
concerned) according to Community legislation. 

(1) 

except  motor  fuels  subject  to  Directive  98/70/EC  of  the  European  Parliament  and  of  the 
Council (OJ L 350, 28.12.1998, p.58) 

CAS No = Chemical Abstracts Service Registry Number. 

# 

+ 

Chemical subject or partially subject to the PIC procedure. 

Chemical qualifying for PIC notification. 

EN 

41 

   EN 

 
 
 
 
PART 2: LIST OF CHEMICALS QUALIFYING FOR PIC NOTIFICATION  

(Article 10) 

This  list  comprises  chemicals  qualifying  for  PIC  notification.  It  generally  does  not  include 
chemicals that are already subject to the PIC procedure, which are listed in Part 3 of this Annex. 

Chemical 

CAS No 

Einecs No 

CN code  Category*  Use limitation** 

2-Naphthylamine 
(naphthalen-2-amine) 
and its salts 

91-59-8, 
553-
00-4,  612-52-2 
and others 

4-Aminobiphenyl 
(biphenyl-4-amine) 
and its salts 

92-67-1, 
2113-61-3 
and others 

202-080-4, 
209-030-0, 
210-313-6 
and others 

202-177-1 
and others 

2921 45 00 

i 

2921 49 80 

i 

4-Nitrobiphenyl 

92-92-3 

202-204-7  2904 20 00 

i 

Acephate  

30560-19-1 

250-241-2  2930 90 70  p 

Aldicarb  

Amitraz  

Asbestos Fibres: 
Chrysotile 

116-06-3 

204-123-2  2930 90 70  p 

33089-61-1 

251-375-4  2925 20 00  p 

12001-29-5 
or 132207-
32-0 

2524 00 00 

i 

Atrazine  

1912-24-9 

217-617-8  2933 69 10  p 

Benzidine and its salts  

92-87-5, 
36341-27-2 
and others 

202-199-
1, 252-
984-8 and 
others 

2921 59 90 

i 

Benzidine derivatives 

- 

- 

Chlorfenapyr 

122453-73-0 

2933 99 90  p 

Chlozolinate 

84332-86-5 

282-714-4  2934 99 90  p 

115-32-3 

204-082-0  2906 29 00  p 

Dicofol  containing  < 
78%  p,p’-Dicofol  or  1 
g/kg of DDT and DDT 
related compounds 

Dinoterb 

1420-07-1 

215-813-8  2908 90 00  p 

Endosulfan 

115-29-7 

204-079-4  2920 90 85  p 

Fenthion  

55-38-9 

200-231-9  2930 90 70  p 

b 

b 

b 

b 

sr 

sr 

b 

sr 

sr 

sr 

b 

b 

b 

b 

sr 

EN 

42 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Fentin acetate 

900-95-8 

212-984-0  2931 00 95  p 

Fentin hydroxide 

76-87-9 

200-990-6  2931 00 95  p 

Methyl parathion # 

298-00-0 

206-050-1  2920 10 00  p 

99688-47-8 

401-210-1  2903 69 90 

i 

- 

400-140-6  2903 69 90 

i 

76253-60-6 

278-404-3  2903 69 90 

i 

Monomethyl-dibromo-
diphenyl methane 
Tradename: DBBT 

Monomethyl-
Dichloro-Diphenyl 
methane; 
Tradename: Ugilec 
121 or Ugilec 21 

Monomethyl-
Tetrachlorodiphenyl 
methane; 
Tradename: Ugilec141 

Nitrofen 

1836-75-5 

217-406-0  2909 30 90  p 

Nonylphenols 
C6H4(OH)C9H19  

Nonylphenol 
ethoxylates 
(C2H4O)nC15H24O 

Octabromodiphenyl 
ether  

Pentabromodiphenyl 
ether  

246-672-0, 

2907 13 00 

i 

284-325-5 

234-284-4 

291-844-0 

203-199-4  

and others 

3402 13 00 

i 
p 

25154-52-3 
(phenol, nonyl-
), 
84852-15-3 
(phenol, 4-
nonyl-, 
branched), 
11066-49-2 
(isononylphenol
), 
90481-04-2, 
(phenol, nonyl-, 
branched), 
104-40-5(p -
nonylphenol) 
and others 

9016-45-9, 
26027-38-3, 
68412-54-4, 
37205-87-1, 
127087-87-0 
and others 

32536-52-0 

251-087-9 

2909 30 38 

i 

32534-81-9 

251-084-2 

2909 30 31 

i 

Pyrazophos 

13457-18-6 

236-656-1 

2933 59 95  p 

Quintozene 

82-68-8 

201-435-0 

2904 90 85  p 

Simazine  

122-34-9 

204-535-2 

2933 69 10  p 

b 

b 

b 

b 

b 

b 

b 

sr 

Sr 
b  

sr 

sr 

b 

b 

sr 

EN 

43 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tecnazene 

117-18-0 

204-178-2 

2904 90 85  p 

56-35-9  and 
others 

200-268-0 
and others 

2931 00 95 
and others 

p 

Triorganostannic 
in 
compounds, 
particular 
tributyltin 
compounds,  including 
bis (tributyltin) oxide 

b 

sr 

* 

** 

Category: p – pesticides. i - industrial chemical  

Use limitation: sr - severe restriction, b – ban (for the category or categories concerned) 

CAS No = Chemical Abstracts Service Registry Number. 

# 

Chemical subject or partially subject to the international PIC procedure 

PART 3: 
ROTTERDAM CONVENTION 

LIST  OF  CHEMICALS  SUBJECT  TO  THE  PIC  PROCEDURE  UNDER  THE 

(Articles 12 and 13) 

(The categories shown are those referred to in the Convention) 

Chemical  

Relevant CAS number(s) 

Category 

2,4,5-T and its salts and esters 

93-76-5# 

Aldrin* 

Binapacryl 

Captafol 

Chlordane* 

Chlordimeform 

Chlorobenzilate 

DDT* 

Dieldrin* 

its 

(DNOC) 
Dinitro-ortho-cresol 
as 
salts 
and 
ammonium  salt,  potassium  salt 
and sodium salt) 

(such 

309-00-2 

485-31-4 

2425-06-1 

57-74-9 

6164-98-3 

510-15-6 

50-29-3 

60-57-1 

534-52-1, 2980-64-5, 
5787-96-2, 2312-76-7 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

EN 

44 

   EN 

 
 
 
 
 
 
Dinoseb and its salts and esters 

88-85-7# 

1,2-dibromoethane (EDB) 

106-93-4 

Ethylene 
dichloroethane) 

dichloride 

(1,2-

107-06-2 

Ethylene oxide 

Fluoroacetamide 

HCH (mixed isomers) 

Heptachlor* 

Hexachlorobenzene* 

Lindane 

Mercury  compounds,  including 
inorganic  mercury  compounds, 
alkyl  mercury  compounds  and 
alkyloxyalkyl and aryl mercury 
compounds 

Monocrotophos 

Parathion 

Pentachlorophenol  and  its  salts 
and esters 

75-21-8 

640-19-7 

608-73-1 

76-44-8 

118-74-1 

58-89-9 

6923-22-4 

56-38-2 

87-86-5# 

Toxaphene* 

8001-35-2 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Dustable  powder  formulations 
containing  a  combination  of: 
Benomyl  at  or  above  7%, 
Carbofuran  at  or  above  10% 
and Thiram at or above 15%  

Methamidophos  
(Soluble  liquid  formulations  of 
the substance that exceed 600 g 
active ingredient/l) 

Methyl-parathion 
(emulsifiable concentrates (EC) 
at 
19.5%active 
ingredient and dusts at or above 
1.5% active ingredient) 

above 

or 

17804-35-2 
1563-66-2 
137-26-8 

10265-92-6 

298-00-0 

Severely hazardous 
pesticide 
formulation 

Severely hazardous 
pesticide 
formulation 

Severely hazardous 
pesticide 
formulation 

Phosphamidon  

13171-21-6 (mixture, 

Severely hazardous 

EN 

45 

   EN 

 
 
 
 
(Soluble  liquid  formulations  of 
the  substance  that  exceed  1000 
g active ingredient/l) 

(E)&(Z) isomers) 
23783-98-4 ((Z)-isomer) 
297-99-4 ((E)-isomer) 

pesticide 
formulation 

Asbestos fibres: 
Actinolite 
Anthophyllite 
Amosite 
Crocidolite 
Tremolite 

Polybrominated biphenyls 
(PBB) 

Polychlorinated biphenyls 
(PCB)* 

Polychlorinated terphenyls 
(PCT) 

Tetraethyl lead 

Tetramethyl lead 

Tris (2,3-dibromopropyl) 
phosphate 

77536-66-4 
77536-67-5 
12172-73-5 
12001-28-4 
77536-68-6 

36355-01-8(hexa-) 
27858-07-7(octa-) 
13654-09-6 (deca-) 

1336-36-3 

61788-33-8 

78-00-2 

75-74-1 

126-72-7 

Industrial 
Industrial 
Industrial 
Industrial 
Industrial 

Industrial 

Industrial 

Industrial 

Industrial 

Industrial 

Industrial 

* 

# 

These substances are subject to an export ban in accordance with the provisions of Article 
14(2) of and Annex V to this Regulation. 

Only the CAS numbers of parent compounds are listed. 

EN 

46 

   EN 

 
 
 
NOTIFICATION OF A BANNED OR SEVERELY RESTRICTED CHEMICAL TO THE 

SECRETARIAT OF THE CONVENTION 

ANNEX II 

Information requirements for notifications pursuant to Article 10  

Notifications shall include: 

1. 

properties, identification and uses 

(a) 

common name; 

(b) 

chemical name according to an internationally recognised nomenclature (for example 
International  Union  of  Pure  and  Applied  Chemistry  (IUPAC)),  where  such 
nomenclature exists; 

(c) 

trade names and names of preparations; 

(d) 

(e) 

code  numbers:  Chemical  Abstracts  Service  (CAS)  number,  Harmonised  System 
Customs Code and other numbers; 

information  on  hazard  classification,  where  the  chemical is subject  to  classification 
requirements;  

(f) 

use or uses of the chemical: 

in the European Union 

elsewhere (if known); 

(g) 

the physico-chemical, toxicological and ecotoxicological properties; 

2. 

final regulatory action 

(a) 

information specific to the final regulatory action: 

(i) 

summary of the final regulatory action; 

(ii) 

reference to the regulatory document; 

(iii)  date of entry into force of the final regulatory action; 

(iv) 

indication of whether the final regulatory action was taken on the basis of a risk 
or hazard evaluation and, if so, information on such an evaluation, covering a 
reference to the relevant documentation; 

(v) 

reasons for the final regulatory action relevant to human health, including the 
health of consumers and workers, or the environment; 

EN 

47 

   EN 

 
(vi)  summary of the hazards and risks presented by the chemical to human health, 
including  the  health  of  consumers  and  workers,  or  the  environment  and  the 
expected effect of the final regulatory action; 

(b) 

category or categories where the final regulatory action has been taken, and for each 
category: 

(i)  Use or uses prohibited by the final regulatory action; 

(ii)  Use or uses that remain allowed; 

(iii)  Estimation, where available, of quantities of the chemical produced, imported, 

exported and used; 

(c) 

an  indication,  to  the  extent  possible,  of  the  likely  relevance  of  the  final  regulatory 
action to other States and regions; 

(d)  other relevant information that may cover: 

(i) 

assessment of socio-economic effects of the final regulatory action; 

(ii) 

information on alternatives and their relative risks, where available, such as: 

– 

– 

integrated pest management strategies; 

industrial practices and processes, including cleaner technology. 

EN 

48 

   EN 

 
EXPORT NOTIFICATION 

ANNEX III 

Information required pursuant to Article 7  

1. 

Identity of the substance to be exported: 

(a) 

name in nomenclature of the International Union of Pure and Applied Chemistry 

(b)  other names (e.g. ISO name, usual names, trade names, and abbreviations) 

(c)  EINECS number and CAS number 

(d)  CUS number (European Customs Inventory of Chemical Substances) and Combined 

Nomenclature code 

(e)  main impurities of the substance, when particularly relevant. 

2. 

Identity of the preparation to be exported: 

(a) 

trade name or designation of the preparation 

(b) 

for each substance listed in Annex I, percentage and details as specified under item 1. 

(c)  CUS number (European Customs Inventory of Chemical Substances) and Combined 

Nomenclature code 

3. 

Information on the export: 

(a) 

country of destination 

(b) 

country of origin 

(c) 

expected date of first export this year 

(d) 

estimated amount of the chemical to be exported to the country concerned this year 

(e) 

intended  use  in  the  country  of  destination,  if  known,  including  information  on  the 
category(ies) under the Rotterdam Convention under which the use falls 

(f) 

name, address and other relevant particulars of the importer or importing company 

(g)  name, address and other relevant particulars of the exporter or exporting company. 

4. 

Designated National Authorities: 

(a)  The  name,  address,  telephone  and  telex,  fax  number  or  E-mail  of  the  designated 

authority in the European Union from which further information may be obtained. 

(b)  The  name,  address,  telephone  and  telex,  fax  number  or  E-mail  of  the  designated 

authority in the importing country. 

EN 

49 

   EN 

 
5. 

6. 

7. 

8. 

9. 

Information  on precautions  to  be  taken, including category of danger and risk and safety 
advice. 

A summary on physico-chemical, toxicological and ecotoxicological properties. 

Use of the chemical in the European Union: 

(a)  Uses, 

category(ies)  under 

the  Rotterdam  Convention 

and  Community 

subcategory(ies) subject to control measure (ban or severe restriction) 

(b)  Uses for which the chemical is not severely restricted or banned 

(Use categories and subcategories as defined in Annex I of the Regulation) 

(c)  Estimation,  where  available,  of  quantities  of  the  chemical  produced,  imported, 

exported and used. 

Information  on  precautionary  measures  to  reduce  exposure  to,  and  emission  of,  the 
chemical. 

Summary of regulatory restrictions and reasons for them. 

Summary of information given in Annex II under point 2 (a), (c) and (d). 

Additional information provided by the exporting Party because considered of concern or 
further information specified in Annex II when requested by the importing Party. 

EN 

50 

   EN 

 
ANNEX IV 

INFORMATION TO BE PROVIDED BY THE DESIGNATED NATIONAL AUTHORITIES OF 

THE MEMBER STATES TO THE COMMISSION IN ACCORDANCE WITH ARTICLE 9  

1. 

Summary of quantities of chemicals (in the form of substances and preparations) subject to 
Annex I exported during the previous year. 

(a)  Year in which exports took place 

(b)  Table summarising quantities of exported chemicals (in the form of substances and 

preparations) as outlined below. 

Chemical 

Importing Country 

Quantity of substance 

… 

… 

… 

2. 

List of importers 

Chemical 

Importing Country 

Importer  or  importing 
company 

Address 
and  other 
relevant  particulars  of 
the 
importer  or 
the 
importing company 

EN 

51 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CHEMICALS AND ARTICLES SUBJECT TO EXPORT BAN 

(Article 14) 

ANNEX V 

Description  of  chemicals/article(s)  subject  to 
export ban  

Additional details, where relevant (e.g. name 
of chemical, EC No, CAS No etc) 

Cosmetic soaps containing mercury 

CN  codes  3401  11  00,  3401  19  00,  3401  20 
10, 3401 20 90, 3401 30 00 

Persistent  organic  pollutants  as  listed  in 
the  Stockholm 
Annexes  A  and  B  of 
Convention  on  Persistent  Organic  Pollutants 
according to the provisions therein 

Aldrin 

Chlordane 

Dieldrin 

DDT (1,1,1-trichloro-
2,2-bis 
(p-chlorophenyl) 
ethane 

Endrin 

Heptachlor 

Hexachlorobenzene 

Mirex 

Toxaphene 
(camphechlor) 

EC  No  206-215-8, 
CAS  No  309-00-2, 
CN code 2903 59 90 

EC  No  200-349-0, 
CAS No 57-74-9, CN 
code 2903 59 90 

EC  No  200-484-5, 
CAS No 60-57-1, CN 
code 2910 90 00 

EC  No  200-024-3, 
CAS No 50-29-3, CN 
code 2903 62 00 

EC  No  200-775-7, 
CAS No 72-20-8, CN 
code 2910 90 00 

EC  No  200-962-3, 
CAS No 76-44-8, CN 
code 2903 59 90 

EC  No  200-273-9, 
CAS  No  118-74-1, 
CN code 2903 62 00 

EC  No  219-196-6, 
CAS  No  2385-85-5, 
CN code 2903 59 90 

EC  No  232-283-3, 
CAS  No  8001-35-2, 
CN code 3808 10 20 

EN 

52 

   EN 

 
 
 
 
Polychlorinated 
biphenyls (PCBs) 

EC  No  215-648-1 
and  others,  CAS  No 
1336-36-3 
and 
others, CN code 2903 
69 90 

EN 

53 

   EN 

 
LIST OF PARTIES TO THE CONVENTION REQUIRING INFORMATION ON TRANSIT 

MOVEMENTS OF CHEMICALS SUBJECT TO THE PIC PROCEDURE 

(Article 15 of this Regulation) 

ANNEX VI 

Country 

Required Information 

EN 

54 

   EN 

 
 
 
 
 
 
 
 
 
 
 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL: 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council 
concerning  the  export  and  import  of  dangerous  chemicals  (to  replace 
Regulation 304/2003) 

2. 

ABM / ABB FRAMEWORK 

Policy Area(s) concerned and associated Activity/Activities: 

Environment  (ABB  Code  0703:  Implementation  of  Community  Environmental 
Policy and legislation). 

3. 

BUDGET LINES 

3.1. 

Budget  lines  (operational  lines  and  related  technical  and  administrative 
assistance lines (ex- B..A lines)) including headings: 

… 

3.2. 

Duration of the action and of the financial impact: 

… 

3.3. 

Budgetary characteristics: 

Budget 
line 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

Comp/ 
Non-comp 

Diff34/ 
Non-
diff35 

Comp/ 
Non-comp 

Diff/ 
Non-diff 

YES/ NO 

YES/NO 

YES/NO 

No […] 

YES/ NO 

YES/NO 

YES/NO 

No […] 

34 
35 

Differentiated appropriations 
Non-differentiated appropriations hereafter referred to as NDA 

EN 

55 

   EN 

 
 
 
                                                 
4. 

SUMMARY OF RESOURCES 

4.1. 

Financial Resources 

4.1.1. 

Summary of commitment appropriations (CA) and payment appropriations (PA) 

Expenditure type 

Section 
no. 

2007 

2008 

2009 

2010 

2011 

2012 
and 
later 

Total 

EUR million (to 3 decimal places) 

Operational expenditure36 

Commitment Appropriations 
(CA) 

8.1. 

Payment 
(PA) 

Appropriations 

a 

b 

Administrative expenditure within reference amount37 

Technical  &  administrative 
assistance (NDA) 

8.2.4. 

c 

TOTAL REFERENCE AMOUNT 

Commitment 
Appropriations 

Payment Appropriations 

a+c 

b+c 

Administrative expenditure not included in reference amount38 

0.108  0.108 

0.108 

0.108 

0.108 

0.108 

0.648 

Human 
associated 
(NDA) 

resources 

and 
expenditure 

8.2.5. 

d 

Administrative  costs,  other 
than  human  resources  and 
not 
associated 
reference 
in 
included 
amount (NDA) 

costs, 

8.2.6. 

e 

Total indicative financial cost of intervention 

TOTAL CA including cost 
of Human Resources 

TOTAL  PA  including  cost 
of Human Resources 

a+c
+d+
e 

b+c
+d+
e 

0.108  0.108 

0.108 

0.108 

0.108 

0.108 

0.648 

0.108  0.108 

0.108 

0.108 

0.108 

0.108 

0.648 

36 
37 
38 

Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 
Expenditure within article xx 01 04 of Title xx. 
Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

EN 

56 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Co-financing details 

If  the  proposal  involves  co-financing  by  Member  States,  or  other  bodies  (please 
specify  which),  an  estimate  of  the  level  of  this  co-financing  should  be  indicated  in 
the table below (additional lines may be added if different bodies are foreseen for the 
provision of the co-financing): 

EUR million (to 3 decimal places) 

n + 1 

n + 2 

n + 3 

n + 4 

Year 
n 

n  +  5 
and 
later 

Total 

Co-financing body 

…………………… 

TOTAL  CA  including  co-
financing 

f 

a+c
+d+
e+f 

4.1.2.  Compatibility with Financial Programming 

X 

Proposal is compatible with existing financial programming. 

(cid:133) 

(cid:133) 

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the  financial 
perspective. 

Proposal  may  require  application  of  the  provisions  of  the  Interinstitutional 
Agreement39 (i.e. flexibility instrument or revision of the financial perspective). 

4.1.3.  Financial impact on Revenue 

X 

Proposal has no financial implications on revenue 

(cid:133) 

Proposal has financial impact – the effect on revenue is as follows: 

Budget line 

Revenue 

EUR million (to one decimal place) 

Prior to
action 
[Year n-
1] 

[Year 
n] 

Situation following action 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

[n+5]40

a) Revenue in absolute terms 

b) Change in revenue 

 Δ 

39 
40 

See points 19 and 24 of the Interinstitutional agreement. 
Additional columns should be added if necessary i.e. if the duration of the action exceeds 6 years 

EN 

57 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
4.2. 

Human Resources FTE (including officials, temporary and external staff) – see 
detail under point 8.2.1. 

Annual requirements 

2007 

2008 

2009 

2010 

2011 

2012 
and 
later 

Total  number  of  human 
resources 

1AST 

1 AST  1 AST 

1 AST 

1 AST 

1 AST 

5. 

CHARACTERISTICS AND OBJECTIVES 

5.1. 

Need to be met in the short or long term 

Better  protection  of  human  health  and  the  environment  in  importing  countries, 
particularly  developing  countries,  against  dangerous  chemicals.  In  particular  to 
ensure that they are provided with adequate information about EU exports and that 
certain  chemicals  that  are  subject  to  the  international  Prior  Informed  Consent 
Procedure  under  the  Rotterdam  Convention  and  chemicals  that  are  banned  or 
severely restricted in the EU within the meaning of that Convention are not exported 
without  the  explicit  consent  of  importing  countries.  To  that  end,  additional  staff 
resources  are  necessary  for  the  development  of  a  harmonised  system  including  a 
greater  role  for  the  Commission  in  seeking  and  obtaining  explicit  consents  from 
importing  countries,  gathering  and  storing  relevant  information  through  the  further 
development  of  the  existing  database  and  making  such  information  available  to  all 
interested parties. 

5.2. 

Value-added  of  Community  involvement  and  coherence  of  the  proposal  with 
other financial instruments and possible synergy 

Without  Community  involvement,  the  current  procedure  for  explicit  consent 
(involving Member States), which gives rise to unnecessary overlaps and duplication 
of  effort,  confusion  in  importing  countries  and  possible  risks  of  inconsistencies  of 
approach, would continue. 

5.3. 

Objectives, expected results and related indicators of the proposal in the context 
of the ABM framework 

Smoother functioning procedures that will maintain protection of human health and 
the  environment  in  importing  countries  without  imposing  unreasonable  burdens  on 
exporters  and  competent  authorities.  In  particular  the  system  should  provide  for 
greater  transparency  and  consistency  and  help  to  reduce  delays  in  handling  cases. 
The rate of responses to requests and the length of time in obtaining those responses 
will be used as indicators to monitor implementation and effects.  

5.4.  Method of Implementation (indicative) 

X 

Centralised Management 

EN 

58 

   EN 

 
 
 
 
 
 
 
 
X 

directly by the Commission 

(cid:133) 

indirectly by delegation to: 

(cid:133) 

executive Agencies 

(cid:133) 

bodies set up by the Communities as referred to in art. 185 of the 
Financial Regulation 

(cid:133) 

national public-sector bodies/bodies with public-service mission 

(cid:133) 

Shared or decentralised management 

(cid:133)  with Member states 

(cid:133)  with Third countries 

(cid:133) 

Joint management with international organisations (please specify) 

Relevant comments: 

6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

Implementation will be continuously reviewed by the Commission and the Member 
States at regular meetings with the competent authorities. 

Member  States  will  be  required  to  report  regularly  on  operation  of  all  procedures 
under the Regulation. The Commission will compile this information together with a 
report on the performance of its functions under the Regulation and submit an overall 
summary report to the Parliament and to the Council. 

6.2. 

Evaluation 

6.2.1.  Ex-ante evaluation 

6.2.2.  Measures taken following an intermediate/ex-post evaluation (lessons  learned from 

similar experiences in the past) 

See  first  report  on  operation  of  Regulation  304/2003  to  date,  accompanying  this 
proposal,  which  confirms  that  the  explicit  consent  procedure  is  not  functioning  as 
smoothly as the rest of the Regulation. 

6.2.3.  Terms and frequency of future evaluation 

Regular evaluation at meetings with competent authorities in the Member States. 

7. 

ANTI-FRAUD MEASURES  

… 

EN 

59 

   EN 

 
8. 

DETAILS OF RESOURCES 

8.1. 

Objectives of the proposal in terms of their financial cost 

Commitment appropriations in EUR million (to 3 decimal places) 

Type of output 

Av. 
cost 

Year n 

Year n+1 

Year n+2 

Year n+3 

Year n+4 

Year n+5 and 
later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

of 

(Headings 
Objectives, 
and 
actions 
outputs should be 
provided) 

OPERATIONAL 
OBJECTIVE  No.1 
41……… 

Action 
1………………. 

- Output 1 

- Output 2 

Action 
2………………. 

- Output 1 

Sub-total 
Objective 1 

OPERATIONAL 
OBJECTIVE  No.2 
1……… 

Action 

41 

As described under Section 5.3 

EN 

60 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
1………………. 

- Output 1 

Sub-total 
Objective 2 

OPERATIONAL 
OBJECTIVE  No.n 
1 

Sub-total 
Objective n 

TOTAL COST 

EN 

61 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.2. 

Administrative Expenditure 

8.2.1.  Number and type of human resources 

Types of post 

Staff to be assigned to management of the action using existing and/or 
additional resources (number of posts/FTEs) 

2007 

2008 

2009 

2010 

2011 

2012 

1 

1 

1 

1 

1 

1 

Officials or 
temporary 
staff42 (XX 01 
01) 

A*/AD 

B*, 
C*/AST 

Staff  financed43  by  art. 
XX 01 02 

Other  staff44  financed by 
art. XX 01 04/05 

TOTAL 

1 

1 

1 

1 

1 

1 

8.2.2.  Description of tasks deriving from the action 

Transmission  to  importing  countries  of  requests  for  explicit  consent;  providing  additional 
information  where  appropriate;  sending  reminders  etc;  where  necessary,  interpreting 
responses; informing parties concerned and entering information on a database. 

8.2.3. 

Sources of human resources (statutory) 

(cid:133) 

(cid:133) 

(cid:133) 

X 

(cid:133) 

Posts currently allocated to the management of the programme to be replaced 
or extended 

Posts pre-allocated within the APS/PDB exercise for year n 

Posts to be requested in the next APS/PDB procedure 

Posts  to  be  redeployed  using  existing  resources  within  the  managing  service 
(internal redeployment) 

Posts required for year 2007 although not foreseen in the APS/PDB exercise of 
the year in question 

42 
43 
44 

Cost of which is NOT covered by the reference amount 
Cost of which is NOT covered by the reference amount 
Cost of which is included within the reference amount 

EN 

62 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.4.  Other  Administrative  expenditure  included  in  reference  amount  (XX  01  04/05  – 

Expenditure on administrative management) 

Budget line 

(number and heading) 

EUR million (to 3 decimal places) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5  

and 
later 

TOTAL 

Technical 

1 
and 
assistance (including related staff costs) 

administrative 

Executive agencies45 

Other 

technical 

and 

administrative 

assistance 

- intra muros  

- extra muros 

Total  Technical  and  administrative 
assistance 

8.2.5.  Financial cost of human resources and associated costs not included in the reference 

amount 

Type of human resources 

2007 

2008 

2009 

2010 

2011 

2012 and 
later 

EUR million (to 3 decimal places) 

Officials and temporary staff (XX 
01 01) 

Staff  financed  by  Art  XX  01  02 
(auxiliary,  END,  contract  staff, 
etc.) 

(specify budget line) 

Total  cost  of  Human  Resources 
and  associated  costs  (NOT  in 
reference amount) 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

0.108 

Calculation– Officials and Temporary agents 

The standard salary for 1 AST as foreseen in Point 8.2.1 is 0.108M€ 

45 

Reference should be made to the specific legislative financial statement for the Executive Agency(ies) 
concerned. 

EN 

63 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Calculation– Staff financed under art. XX 01 02 

… 

8.2.6. Other administrative expenditure not included in reference amount 

EUR million (to 3 decimal places)

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 

and 
later 

TOTAL 

XX 01 02 11 01 – Missions 

XX 01 02 11 02 – Meetings & Conferences 

XX 01 02 11 03 – Committees46  

XX 01 02 11 04 – Studies & consultations 

XX 01 02 11 05 - Information systems 

2  Total  Other  Management  Expenditure 

(XX 01 02 11) 

3  Other  expenditure  of  an  administrative 
nature (specify including reference to budget 
line) 

Total  Administrative  expenditure,  other 
than human resources and associated costs 
(NOT included in reference amount) 

Calculation - Other administrative expenditure not included in reference amount 

… 

The  needs  for  human  and  administrative  resources  shall  be  covered  within  the  allocation 
granted to the managing DG in the framework of the annual allocation procedure. 

46 

Specify the type of committee and the group to which it belongs. 

EN 

64 

   EN