Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the export and import of dangerous chemicals(recast)
Date: 2011-05-05
Institutions: European Commission
Subjects: chemical product, dangerous substance, environmental protection, environmental risk prevention, export, import, product safety, public health

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EUROPEAN COMMISSION 

Brussels, 5.5.2011 
COM(2011) 245 final 

2011/0105 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

concerning the export and import of dangerous chemicals 

(recast) 

(Text with EEA relevance) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. 

Grounds for and objectives of the proposal 

Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 
concerning the export and import of dangerous chemicals1 ('the Regulation') implements the 
Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous 
chemicals and pesticides in international trade.  

The following reasons lead to the proposal to recast Regulation (EC) No 689/2008: 

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2 

The  Regulation  includes  references  to  Council  Directive  67/548/EEC  of  27  June 
1967  on  the  approximation  of  the  laws,  regulations  and  administrative  provisions 
relating  to  the  classification,  packaging  and  labelling  of  dangerous  substances  and 
Directive  1999/45/EC  of  the  European  Parliament  and  of  the  Council  of  31  May 
1999  concerning  the  approximation  of  the  laws,  regulations  and  administrative 
provisions  of  the  Member  States  relating  to  the  classification,  packaging  and 
labelling  of  dangerous  preparations,  which  are  or  will  be  replaced  and  repealed  by 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December  2008  on  classification,  labelling  and  packaging  of  substances  and 
mixtures,  amending  and  repealing  Directives  67/548/EEC  and  1999/45/EC,  and 
amending  Regulation  (EC)  1907/20062.  It  is,  therefore,  necessary  to  align  the 
Regulation with Regulation (EC) No 1272/2008. 

In  order  to  support  the  Commission  in  its  tasks  as  a  common  designated  authority 
foreseen  under  the  Regulation,  it  is  proposed  to  involve  the  European  Chemicals 
Agency  ("the  Agency")  in  certain  administrative,  technical  and  scientific  tasks 
necessary for the implementation of the Regulation. 

In  the  light  of  Regulation  (EC)  No 1272/2008  and  of  the  experience  of  the 
functioning of the procedures under Regulation (EC) No 689/2008, it is appropriate 
to  include  certain  technical  amendments  to  the  operative  provisions  such  as  clarify 
the  definitions  of  a  substance,  a  mixture  and  an  article,  and  request  the  use  of  the 
reference identification number for exports that are not subject to export notification. 

In the light of the experience gained with the implementation of the explicit consent 
procedure provided for by Regulation (EC) No 689/2008 it is appropriate to provide 
for additional conditions that may allow exports to proceed in the absence of a reply 
from the importing country whilst not lowering the protection afforded to importing 
countries. 

In  view  of  the  changes  introduced  by  the  Lisbon  Treaty,  it  is  necessary  to  clarify 
provisions relating to the external representation of the European Union and to adapt 
the  provisions  concerning  comitology.  In  particular,  it  should  be  specified  which 

OJ L 204, 31.7.2008, p. 1 
OJ L 353, 31. 12. 2008, p. 1 

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rules  are  subject  to  implementing  acts  and  clarified  which  conditions  apply  to  the 
adoption of delegated acts. 

1.2. 

General context 

The  Rotterdam  Convention  was  adopted  in  September  1998.  It  entered  into  force  on  24 
February 2004. The aim of the Rotterdam Convention is to promote shared responsibility and 
co-operative  efforts  among  the  Parties  in  the  international  trade  of  dangerous  chemicals  in 
order to protect human health and the environment from potential harm and to contribute to 
their environmentally sound use. This is done by facilitating information exchange about their 
characteristics,  by  providing  for  a  national  decision-making  process  on  their  import  and 
export and by disseminating these decisions to Parties. 

Regulation (EC) No 689/2008 implements the Rotterdam Convention on the Prior Informed 
Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade. 
The  provisions  of  the  Regulation  go  beyond  those  of  the  Convention  and  offer  more 
protection to importing countries since they are addressed to all countries and not just Parties 
to the Convention. The scope of the Regulation is not limited to chemicals that are banned or 
severely restricted under the Convention but also covers chemicals that are banned or severely 
restricted at EU level. In addition the Regulation ensures that all chemicals are appropriately 
packed and labelled when exported. 

1.3. 

Existing provisions in the area of the proposal 

As  noted  above,  the  current  Union  rules  relating  to  the  export  and  import  of  dangerous 
chemicals  are  laid  down  in  Regulation  (EC)  No  689/2008,  as  most  recently  amended  by 
Commission Regulation (EU) No 196/20103. 

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

1. 

2. 

The  rules  apply  to  exports  to  all  countries,  whether  or  not  they  are  Parties  to  the 
Convention;  

The Regulation stipulates the obligation of an annual export notification for a wider 
range  of  chemicals.  For  the  purposes  of  determining  which  chemicals  should  be 
subject to the procedure, the two use categories (pesticides and industrial chemicals) 
foreseen by the Convention 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  containing  such  chemicals  are  also 
covered; 

3. 

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

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OJ L 60, 10.3.2010, p. 5 

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4. 

5. 

Certain  articles  and  chemicals  (such  as  those  chemicals  that  are  also  subject  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  Union  unless  third  countries  require 
otherwise. 

1.4. 

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. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENT 

2.1. 

Consultation of interested parties 

Consultation methods, main sectors targeted and the general background 

Due  to  the  nature  of  the  recast,  which  introduces  only  minor  technical  amendments  to  the 
operative  provisions,  it  was  not  deemed  necessary  to  carry  out  a  formal  consultation  of 
stakeholders.  

Relevant  stakeholders  have  been  informed  within  the  framework  of  the  meetings  of 
Designated  National  Authorities  (DNAs)  under  Regulation  (EC)  No  689/2008  about  the 
intended modifications. 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.  

Summary of responses and how these have been taken into account 

All  Member  States  and  other  stakeholders  participating  in  the  meetings  of  Designated 
National  Authorities  (DNAs)  under  Regulation  (EC)  No  689/2008  supported  the  intended 
changes including the transfer of tasks to the Agency. 

2.2. 

Collection and use of expertise 

As  no  substantive  changes  are  proposed  in  the  context  of  this  review,  it  was  not  deemed 
necessary to make use of external expertise.  

2.3. 

Impact assessment 

The  current  rules  set  out  in  the  Regulation  are  generally  working  well  and  only  minor 
technical modifications are necessary to facilitate the implementation. The main changes aim 
to  align  the  Regulation  to  the  Lisbon  Treaty  and  general  chemicals  legislation  as  well  as  to 
involve the Agency in the tasks foreseen under the Regulation. As the overall impact of the 
review  is  expected  to  be  limited,  it  was  not  considered  imperative  to  carry  out  an  impact 
assessment. The main effects of the changes can be summarised as follows: 

– 

As  a  result  of  the  proposed  changes,  there  will  be  more  clarity,  transparency  and 
increased  legal  certainty  for  all  parties  involved  in  the  implementation  of  the 
Regulation;  

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– 

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The proposal will not add any additional administrative burden for exporters or the 
competent  authorities  involved  in  the  implementation  of  the  Regulation.  On  the 
contrary,  with  respect  to  exports  that  are  exempted  from  export  notification  the 
proposed amendments will lead to a reduction of administrative burdens; 

Some  tasks  will  be  transferred  from  the  Commission  to  the  European  Chemicals 
Agency, which is expected to reduce the overall costs and to increase the scientific 
knowledge available for implementation; 

The  current  high  level  of  protection  of  human  health  and  the  environment  will  be 
maintained.  

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. 

Summary of the proposed action 

The  proposed  new  Regulation  would  essentially  maintain  all  provisions  of  the  current 
Regulation,  including  those  that  go  beyond  the  requirements  of  the  Convention.  However, 
certain technical amendments are deemed necessary to improve the clarity and functioning of 
the Regulation. The main changes are as follows: 

– 

Changes and clarifications as regards certain definitions (Article 3) 

Definitions  are  amended  in  order  to  align  this  Regulation  with  Regulation  (EC) 
No 1272/2008. The term ‘preparation’ has been replaced by ‘mixture’ to reflect the 
changes in the general chemicals legislation and a definition for ‘substance’ is added. 

– 

Changes to the so-called 'explicit consent' procedure (Article 14(7)) 

In  around  30%  of  the  cases  to  date,  despite  the  efforts  made  by  the  DNAs  of  the 
exporting Member States and the Commission 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  the  substances  are 
often not banned or severely restricted in the importing countries. The current system 
thus  causes  difficulties  for  exporters  and  the  DNAs  of  exporting  Member  States 
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 Union within a Convention use category and thus qualifying for PIC 
notification  but  that  are  not  yet  PIC  chemicals)  is  particularly  problematic  because 
authorities in importing countries are not always aware of EU procedures or do not 
always have the mandate or the means to respond. 

Against  this  background,  certain  limited  possibilities  for  exports  to  proceed  on  a 
temporary basis, while further efforts are being made to obtain explicit consent, seem 
appropriate.  It  is  proposed  to  allow  the  export  to  proceed  if  there  is  documentary 
evidence from official sources showing that the chemical has been imported or used 
in the last 5 years and no regulatory action has been taken, if, despite all reasonable 
efforts by the exporter’s DNA, the Agency and the Commission, there is no response 
from the importing country within 2 months. The evidence showing that the chemical 
is  imported  in  the  country  can  be  regarded  as  sufficient  indication  of  consent  for 
exports  to  proceed  ad  interim  for  a  period  of  12  months  pending  a  response.  This 

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would  be  compatible  with  the  so-called  "status  quo"  provisions  of  Article  11(2)  of 
the  Convention,  but  would  be  more  restrictive.  Moreover  import  licenses  are 
frequently specific to a given product or supplier or importer so that the possibility 
for exports to proceed would be limited accordingly.  

– 

Involvement of the European Chemicals Agency (Articles 6 and 24) 

The involvement of the Agency in the implementation of this Regulation is because 
of  its  expertise  and  experience  with  the  implementation  of  the  general  chemicals 
legislation  and  international  agreements  on  chemicals  considered  particularly 
desirable,  in  particular  regarding  the  management  of  the  European  Database  on 
Export and Import of dangerous chemicals and some related administrative tasks.  

– 

Adaptation  of  provisions  related  to  the  external  representation  of  the  Union  and  of 
the comitology procedures to the Lisbon Treaty (Articles 5 and 26 to 29) 

The provisions related to the external representation of the Union have been aligned 
with the Lisbon Treaty. The provisions in which certain powers are conferred upon 
the  European  Commission  have  also  been  revised  in  order  to  reflect  the  entry  into 
force of the Lisbon Treaty. 

3.2. 

Legal basis 

In  line  with  the  judgment  of  the  Court  in  case  C-178/03  (Commission  v  Parliament  and 
Council)4, the proposed Regulation will be based on Article 192(1) (relating to Environmental 
Protection) of the Treaty on the functioning of the European Union and Article 207 (relating 
to the Common Commercial Policy).  

3.3. 

Subsidiarity principle 

The  subsidiarity  principle  applies  insofar  as  the  proposal  does  not  fall  under  the  exclusive 
competence  of  the  European  Union.  The  proposal  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 Union, as a Party to the Convention, meets 
its international obligations. 

3.4. 

Proportionality principle 

The proposal complies with the proportionality principle since it does not go beyond what is 
necessary  to  achieve  its  objectives.  It  concentrates  on  changes  only  where  they  are  deemed 
necessary  and  appropriate  for  its  proper  functioning  or  where  they  are  necessary  due  to 
changes in other legislation. 

Furthermore, the proposal aims to reduce the administrative burden without compromising the 
level of protection afforded to human health and the environment. 

3.5. 

Choice of instrument 

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

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ECR (2006), I-107. 

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4. 

BUDGETARY IMPLICATION  

The  proposal  is  not  expected  to  have  important  budgetary  implications  since  no  new  tasks 
were  introduced  compared  to  Regulation  (EC)  689/2008.  The  transfer  of  certain  tasks  from 
the Commission to the European Chemicals Agency is expected to reduce the overall costs of 
implementation.  Further  reductions  may  be  achieved  in  a  long-term  perspective  considering 
the potential for synergies with other tasks of the Agency.  

The financing of the tasks carried out by the European Chemicals Agency will be provided in 
form of a subsidy from the Union budget. 

5. 

OPTIONAL ELEMENTS  

5.1. 

Review/revision/sunset clause 

The proposal includes a review clause, which is limited to the possibility to charge fees for 
services provided by the Agency. However, the Commission is obliged to regularly report on 
the implementation of the Regulation to the European Parliament and the Council. 

5.2. 

Recasting 

The proposal involves recasting. 

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(cid:208) 689/2008 (adapted) 
(cid:214) new 
2011/0105 (COD) 

REGULATION (EUC) No 689/2008 OF THE EUROPEAN PARLIAMENT AND OF 
THE COUNCIL 

of 17 June 2008 

concerning the export and import of dangerous chemicals 

(cid:214) (Text with EEA relevance)  

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty ⌦ on the Functioning of the European Union ⌫establishing the 
European  Community,  and  in  particular  ⌦ Article  192(1)  and  Article  207 ⌫Articles  133 
and 175(1) thereof, 

Having regard to the proposal from the ⌦ European ⌫ Commission, 

⌦ After transmission of the draft legislative act to the national Parliaments, ⌫  

Having regard to the Opinion of the European Economic and Social Committee5, 

⌦ Having regard to the opinion of ⌫After consulting the Committee of the Regions, 

Acting in accordance with the ⌦ ordinary legislative ⌫ procedure laid down in Article 251 
of the Treaty6, 

Whereas: 

(1) 

A number of substantial changes should be made to Regulation (EC) No 689/2008 of 
the  European  Parliament  and  of  the  Council  of  17 June  2008  concerning  the  export 
and  import  of  dangerous  chemicals7.  In  the  interest  of  clarity,  Regulation  (EC)  No 
689/2008 should be recast. 

(cid:216) new 

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7 

OJ C 175, 27.7.2007, p. 40. 
Opinion of the European Parliament of 15 January 2008 (not yet published in the Official Journal) and 
Council Decision of 5 June 2008. 
OJ L 204, 31.7.2008, p. 1.  

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(cid:208) 689/2008 recital (1) 

(21)  Regulation  (EC)  No 689/2008  304/2003  of  the  European  Parliament  and  of  the 
Council of 28 January 2003 concerning the export and import of dangerous chemicals8 
implementsed the Rotterdam Convention on the prior informed consent procedure for 
certain  hazardous  chemicals  and  pesticides  in  international  trade9,  hereinafter  ‘the 
Convention’, which entered into force on 24 February 2004, and replaces Regulation 
(EC) No 304/2003 of the European Parliament and of the Council of 28 January 2003 
concerning  the  export  and  import  of  dangerous  chemicals10  replaced  Council 
Regulation  (EEC)  No 2455/92  of  23 July  1992  concerning  the  export  and  import  of 
certain dangerous chemicals11. 

(2) 

(3) 

(cid:208) 689/2008 recital (2) 

In its judgment of 10 January 2006 in Case C-178/03 (Commission v Parliament and 
Council)12,  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  to  be  maintained  until  the  adoption, 
within  a  reasonable  period,  of  a  new  Regulation  founded  on  appropriate  legal  bases. 
That  also  implies  that  obligations  that  were  already  fulfilled  under  Regulation  (EC) 
No 304/2003 do not need to be accomplished again. 

(cid:216) new 

For  reasons  of  clarity  and  consistency  with  other  relevant  Union  legislation,  certain 
definitions should be introduced or clarified and  terminology should be  aligned with 
that  used  in  Regulation  (EC)  No  1907/2006  of  the  European  Parliament  and  of  the 
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, 
amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 
and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council  Directive 
76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC13, on the one hand, and Regulation (EC) No 1272/2008 of the European 
Parliament  and  of  the  Council  of  16  December  2008  on  classification,  labelling  and 
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC 
and 1999/45/EC, and amending Regulation (EC) 1907/200614 on the other hand. 

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12 
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OJ  L 63,  6.3.2003,  p. 1.  Regulation  as  last  amended  by  Commission  Regulation  (EC)  No 1376/2007 
(OJ L 307, 24.11.2007, p. 14). 
OJ L 63, 6.3.2003, p. 29. 
OJ L 63, 6.3.2003, p. 1  
OJ L 251, 29.8.1992, p. 13. Regulation as last amended by Commission Regulation (EC) No 300/2002 
(OJ L 52, 22.2.2002, p. 1). 
ECR [2006], I-107. 
OJ L 396, 30.12.2006, p. 1. 
OJ L 353, 31. 12. 2008, p. 1. 

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(3) 

(4) 

(5) 

(6) 

(cid:208) 689/2008 recital (3) 

In  accordance  with  Regulation  (EC)  No 304/2003,  the  Commission  has  submitted  a 
report to the European Parliament and the Council on the operation of Regulation (EC) 
No 304/2003 from 2003 to 2005. 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 incorporate those elements in this Regulation. 

(cid:208) 689/2008 recital (4) (adapted) 
(cid:214) new 

The  Convention  allows  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.  It  is  necessary  and  appropriate,  in  order  not  to 
(cid:214) ensure  a  higher   weaken  the  level  of  protection  ⌦ of ⌫  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. 

(cid:208) 689/2008 recital (5) 

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

(cid:216) new 

There is a need to ensure the effective coordination and management of technical and 
administrative  aspects  of  this  Regulation  at  Union  level.  The  European  Chemicals 
Agency  ("the  Agency")  established  by  Regulation  (EC)  No  1907/2006  has  the 
competence  and  experience  in  implementing  Union  legislation  on  chemicals  and 
international agreements on chemicals. The Agency should, therefore, carry out tasks 
with  regard 
the 
implementation  of  this  Regulation  and  the  exchange  of  information.  In  addition,  the 
Agency  should  support  the  Commission  in  implementing  the  Union's  international 
obligations under the Convention. 

technical  and  scientific  aspects  of 

the  administrative, 

to 

(cid:208) 689/2008 recital (12) (adapted) 
(cid:214) new 

(7)  (cid:214) Given that certain tasks of the Commission should be transferred to the Agency, the 
European  Database  on  Export  and  Import  of  Dangerous  Chemicals  initially   The 
database  established  by  the  Commission  (cid:214) should  be  further  developed  and 
maintained  by  the  Agency. ,  is  an  important  tool  which  should  underpin  the 
application of this Regulation and its control. 

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(cid:208) 689/2008 recital (6) (adapted) 

(86)  Exports of dangerous chemicals that are banned or severely restricted within the Union 
Community should continue to be subject to a common export notification procedure. 
Accordingly, dangerous chemicals, whether in the form of substances on their own or 
in  ⌦ mixtures ⌫  preparations  or  in  articles,  which  have  been  banned  or  severely 
restricted  by  the  Union  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  export  notification  rules  similar  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  prior  informed 
consent  (PIC)  procedure  should  also  be  subject  to  the  same  rules.  This  export 
notification procedure should apply to Union 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. 

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

(cid:208) 689/2008 recital (7) 

(cid:208) 689/2008 recital (8) 

(108)  Notifications  to  the  Secretariat  of  the  Convention  of  Union  Community  or  Member 
State final 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. 

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

(cid:208) 689/2008 recital (9) 

(cid:208) 689/2008 recital (10) 

(1210) It is also necessary to ensure that the Union Community take decisions with regard to 
the import into the Union Community of chemicals that are subject to the international 
PIC  procedure.  These  decisions  should  be  based  on  applicable  Union  Community 
legislation  and  take  into  account  bans  or  severe  restrictions  imposed  by  Member 
States.  Where  justified,  amendments  to  Union  Community  legislation  should  be 
proposed. 

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(cid:208) 689/2008 recital (11) 

(1311) 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  those  decisions. 
Furthermore, in order to prevent undesired exports, no chemicals banned or severely 
restricted  within  the  Union  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 countries that are 
members  of  the  Organisation  for  Economic  Cooperation  and  Development  (OECD) 
provided  that  certain  conditions  are  met.  Furthermore  a  procedure  is  needed  to  deal 
with  cases  in  which,  despite  all  reasonable  efforts,  no  response  is  obtained  from  the 
importing  country,  so  that  exports  of  certain  chemicals  may  proceed  on  a  temporary 
basis under specified conditions. It is also necessary to provide for periodic review of 
all such cases as well as those in which explicit consent is obtained. 

(cid:208) 689/2008 recital (13) 

(1413) It is also important that all chemicals exported have an adequate shelf-life so that they 
may be used effectively and safely. As regards pesticides, in particular and especially 
those  exported  to  developing  countries,  it  is  essential  that  information  about 
appropriate  storage  conditions  be  provided  and  that  suitable  packaging  and  sizes  of 
containers are used to avoid creating obsolete stocks. 

(cid:208) 689/2008 recital (14) 

(1514) 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  certain  conditions  of  use  or  disposal  and  that  are  banned  or  severely 
restricted in the Union 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. 

(1615) 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 who request such information. 

(cid:208) 689/2008 recital (15) 

(1716) Union  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  those  provisions  would  conflict  with  any  specific  requirements  of 

(cid:208) 689/2008 recital (16) 
(cid:214) new 

EN 

12 

   EN 

 
 
 
 
 
those  countries,  taking  into  account  relevant  international  standards.  (cid:214) In  order  to 
ensure  the  full  effectiveness  of  this  Regulation,  those  rules  should  also  apply  to 
chemicals  under  customs  supervision  with  a  view  to  their  re-exportation.  Since 
Regulation (EC) No 1272/2008 established new provisions on classification, labelling 
and  packaging  of  substances  and  mixtures,  a  reference  to  that  Regulation  should  be 
included.  

(cid:208) 689/2008 recital (17) (adapted) 
(cid:214) new 

(1817) In  order  to  ensure  effective  control  and  enforcement  of  the  rules,  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.  

(19)  ⌦ In order ⌫ tTo 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 should be established. (cid:214) The codes should also 
be used for chemicals exported for the purpose of research or analysis in quantities not 
likely to affect health or the environment, and in any event not more than 10 kg per 
year.  In order to allow all parties time to become accustomed to this system before 
it becomes mandatory a short transitional period should be provided for. 

(cid:208) 689/2008 recital (18) 

(2018) Information  exchange,  shared  responsibility  and  cooperative  efforts  between  the 
Union  Community  and  the  Member  States  and  third  countries  should  be  promoted 
with a view  to  ensuring sound 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,  especially  assistance  seeking  to  enable 
those countries to implement the Convention. 

(cid:208) 689/2008 recital (19) 
(cid:214) new 

(2119) There should be regular monitoring of the operation of the procedures if they are to be 
effective.  To  this  end,  Member  States  (cid:214) and  the  Agency   should  regularly  submit 
reports  to  the  Commission,  which  should  in  turn  regularly  report  to  the  European 
Parliament and the Council. 

(2220) Technical  notes  for  guidance  should  be  drawn  up  (cid:214) by  the  Agency   to  assist  the 
competent  authorities,  including  such  authorities  as  customs  controlling  exports, 
(cid:214) exporters and importers  in the application of this Regulation. 

(cid:208) 689/2008 recital (20) 
(cid:214) new 

EN 

13 

   EN 

 
 
 
 
(cid:208) 689/2008 recital (22) (adapted) 
(cid:214) new 

(2322) In  particular  t  The  Commission  should  be  empowered  to  adopt  (cid:214) delegated  acts  in 
accordance with Article 290 of the Treaty in respect of the following: modifications of 
the lists of chemicals in Annex I,  measures to include a chemical in Parts 1 or 2 of 
Annex I  following  final  regulatory  action  at  Community  level,  ⌦ inclusion  of ⌫ 
measures to include a chemical that is subject to Regulation (EC) No 850/2004 of the 
European  Parliament  and  of  the  Council  of  29 April  2004  on  persistent  organic 
pollutants15 
including 
modifications to existing entries, ⌦ inclusion of ⌫ measures to include a chemical 
already  subject  to  an  export  ban  at  Union  Community  level  in  Part  2  of  Annex V, 
⌦ modifications  of ⌫  measures  to  amend  Annexes II,  III,  IV  and  VI,  and 
⌦ modifications of ⌫ measures to modify existing entries in Annex V. Since those 
measures  are  of  general  scope  and  are  designed  to  amend  non-essential  elements  of 
this  Regulation,  they  must  be  adopted  in  accordance  with  the  regulatory  procedure 
with scrutiny provided for in Article 5a of Decision 1999/468/EC, 

in  Part  1  of  Annex V,  measures 

to  amend  Annex I, 

(cid:208) 689/2008 recital (21) (adapted) 
(cid:214) new 

(2421) (cid:214) In  order  to  ensure  uniform  conditions   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  ⌦ should  be ⌫  conferred  on  the  Commission16.  (cid:214) Those 
powers should be exercised in accordance with Regulation (EU) No 182/2011 of the 
European  Parliament  and  of  the  Council  of  16  February  2011  laying  down  the  rules 
and general principles concerning mechanisms for control by the Member States of the 
Commission's exercise of implementing powers17.  

(cid:216) new 

(25) 

In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on 
the European Union, the objectives of ensuring coherent and effective implementation 
of the Union's obligations under the Convention cannot be sufficiently achieved by the 
Member  States  and  can  therefore,  by  reason  of  the  necessity  to  harmonise  the  rules 
concerning  imports  and  exports  of  chemicals,  be  better  achieved  by  the  Union.  In 
accordance  with  the  principle  of  proportionality,  as  set  out  in  that  Article,  this 
Regulation does not go beyond what is necessary in order to achieve those objectives. 

(26)  Regulation (EC) No 689/2008 should be repealed. 

(cid:216) new 

15 

16 

17 

OJ L 158, 30.4.2004, p. 7. Regulation as last amended by Commission Regulation (EC) No 323/2007 
(OJ L 85, 27.3.2007, p. 3). 
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 55, 28.2.2011, p. 13. 

EN 

14 

   EN 

 
 
 
 
                                                 
(27) 

It  is  appropriate  to  provide  for  the  deferred  application  of  this  Regulation  so  as  to 
allow  the  Agency  sufficient  time  to  prepare  its  new  role  and  to  the  industry  to 
familiarise itself with the new procedures, 

(cid:216) new 

HAVE ADOPTED THIS REGULATION: 

(cid:208) 689/2008 

(cid:208) 689/2008 Article 1 
(cid:214) new 

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 the environmentally sound use of hazardous chemicals. 

The objectives referred to in the first subparagraph shall be achieved by facilitating 
the  exchange  of  information  concerning  the  characteristics  of  such  chemicals,  by 
providing  for  a  decision-making  process  within  the  Union  Community  on  their 
import  and  export  and  by  disseminating  decisions  to  Parties  and  other  countries  as 
appropriate. 

In addition to the objectives referred to in paragraph 1, this Regulation shall ensure 
that the provisions of Council Directive 67/548/EEC18 and of Directive 1999/45/EC 
of  the  European  Parliament  and  of  the  Council19  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  (cid:214) and,  where  applicable, 

Council  Directive  67/548/EEC  of  27 June  1967  on  the  approximation  of  laws,  regulations  and 
administrative provisions relating to the classification, packaging and labelling of dangerous substances 
(OJ  196,  16.8.1967,  p. 1).  Directive  as  last  amended  by  Directive  2006/121/EC  of  the  European 
Parliament  and  of  the  Council  (OJ  L 396,  30.12.2006,  p. 850).  Corrected  version  in  OJ  L 136, 
29.5.2007, p. 281. 
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the 
approximation of the laws, regulations and administrative provisions of the Member States relating to 
the  classification,  packaging  and  labelling  of  dangerous  preparations  (OJ  L 200,  30.7.1999,  p. 1). 
Directive  as  last  amended  by  Regulation  (EC)  No 1907/2006  (OJ  L 396,  30.12.2006,  p. 1).  Corrected 
version in OJ L 136, 29.5.2007, p. 3. 

2. 

18 

19 

EN 

15 

   EN 

 
 
 
                                                 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council also 
apply to all such chemicals when they are exported from the Member States to other 
Parties  or  other  countries,  unless  those  provisions  would  conflict  with  any  specific 
requirements of those Parties or other countries. 

(cid:208) 689/2008 Article 2 
(cid:214) new 

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 
Union Community or a Member State; 

chemicals  when  exported  in  so  far  as  their  classification,  packaging  and 
labelling are concerned. 

2. 

This Regulation shall not apply to any of the following: 

(a) 

(b) 

narcotic  drugs  and  psychotropic  substances  covered  by  Council  Regulation 
(EC)  No 111/200520  of  22 December  2004  laying  down  rules  for  the 
monitoring  of  trade  between  the  Community  and  third  countries  in  drug 
precursors; 

radioactive  materials  and  substances  covered  by  Council  Directive 
96/29/Euratom21  of  13 May  1996  laying  down  basic  safety  standards  for  the 
protection of the health of workers and the general public against the dangers 
arising from ionizing radiation; 

(c)  wastes covered by Directive 2006/12/EC of the European Parliament and of the 
Council22  of  5 April  2006  on  waste  and  Council  Directive  91/689/EEC23  of 
12 December 1991 on hazardous waste; 

(d) 

chemical  weapons  covered  by  Council  Regulation  (EC)  No 1334/200024  of 
22 June 2000 setting up a Community regime for the control of exports of dual-
use items and technology; 

20 
21 
22 
23 

24 

OJ L 22, 26.1.2005, p. 1. 
OJ L 159, 29.6.1996, p. 1. 
OJ L 114, 27.4.2006, p. 9. 
OJ  L 377,  31.12.1991,  p. 20.  Directive  as  last  amended  by  Regulation  (EC)  No 166/2006  of  the 
European Parliament and of the Council (OJ L 33, 4.2.2006, p. 1). 
OJ  L 159,  30.6.2000,  p. 1.  Regulation  as  last  amended  by  Regulation  (EC)  No 1183/2007  (OJ  L 278, 
22.10.2007, p. 1). 

EN 

16 

   EN 

 
                                                 
(e) 

(f) 

food  and  food  additives  covered  by  Regulation  (EC)  No 882/2004  of  the 
European Parliament and of the Council25 of 29 April 2004 on official controls 
performed  to  ensure  the  verification  of  compliance  with  feed  and  food  law, 
animal health and animal welfare rules; 

feedingstuffs  covered  by  Regulation  (EC)  No 178/2002  of  the  European 
Parliament  and  of  the  Council26  of  28 January  2002  laying  down  the  general 
principles  and  requirements  of  food  law,  establishing  the  European  Food 
Safety  Authority  and  laying  down  procedures  in  matters  of  food  safety 
including  additives,  whether  processed,  partially  processed  or  unprocessed, 
intended to be used for oral feeding to animals; 

(g)  genetically  modified  organisms  covered  by  Directive  2001/18/EC  of  the 
European Parliament and of the Council27 of 12 March 2001 on the deliberate 
release into the environment of genetically modified organisms; 

(h) 

save  to  the  extent  covered  by  Article 3(54)(b)  of  this  Regulation,  proprietary 
medicinal  products  and  veterinary  medicinal  products  covered  by  Directive 
2001/83/EC  of  the  European  Parliament  and  of  the  Council28  of  6 November 
2001 on the Community code relating to medicinal products for human use and 
Directive  2001/82/EC  of  the  European  Parliament  and  of  the  Council29  of 
6 November  2001  on  the  Community  code  relating  to  veterinary  medicinal 
products. 

3. 

(i)  (cid:214) This  Regulation  shall  not  apply  to   chemicals  in  quantities  not  likely  to 
affect health or the environment, and in any event not more than 10 kg (cid:214) per year, 
per  exporter  and  per  importing  country ,  provided  that  they  are  imported  or 
exported for the purpose of research or analysis. 

(cid:214) However,  exporters  of  the  chemicals  referred  to  in  the  first  subparagraph  shall 
obtain and provide a reference identification number in accordance with paragraphs 2 
and 3 of Article 19.  

(cid:208) 689/2008 Article 3 (adapted) 
(cid:214) new 

Article 3 
Definitions 

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

25 

26 

27 

28 

29 

OJ L 165, 30.4.2004, p. 1. Corrected version in OJ L 191, 28.5.2004, p. 1. Regulation as last amended 
by Council Regulation (EC) No 301/2008 (OJ L 97, 9.4.2008, p. 85). 
OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ 
L 100, 8.4.2006, p. 3). 
OJ  L 106,  17.4.2001,  p. 1.  Directive  as  last  amended  by  Directive  2008/27/EC  (OJ  L 81,  20.3.2008, 
p. 45). 
OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2008/29/EC (OJ L 81, 20.3.2008, 
p. 51). 
OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, 
p. 58). 

EN 

17 

   EN 

 
                                                 
1. 

2. 

3. 

4. 

‘chemical’ means a substance as defined in Directive 67/548/EEC, whether by itself 
or  in  a  ⌦ mixture ⌫  preparation,  or  a  ⌦ mixture ⌫  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; 

(cid:214) 'substance' means any chemical element and its compounds as defined in point 1 
of Article 3 of Regulation (EC) No 1907/2006;  

‘ ⌦ mixture ⌫ preparation’ means a mixture or a solution ⌦ as defined in 
2. 
point 8 of Article 2 of Regulation (EC) No 1272/2008 ⌫ 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 Union Community legislation in 
that particular product (cid:214) where that product does not fall under points 2 or 3  ; 

5. 

4. 

‘pesticides’ means chemicals in either of the following subcategories: 

(a) 

pesticides  used  as  plant  protection  products  covered  by  Regulation  (EC)  No 
1107/2009 of the European Parliament and of the Council30 Council Directive 
91/414/EEC  of  15 July  1991  concerning  the  placing  of  plant  protection 
products on the market; 

(b)  other  pesticides,  such  as  biocidal  products  under  Directive  98/8/EC  of  the 
European Parliament and of the Council31 of 16 February 1998 concerning the 
placing  of  biocidal  products  on  the  market  and  such  as  disinfectants, 
insecticides  and  parasiticides  covered  by  Directive  2001/82/EC  and  Directive 
2001/83/EC; 

‘industrial  chemicals’  means  chemicals 

5. 
subcategories: 

in  either  of 

the 

following 

(a) 

chemicals for use by professionals; 

(b) 

chemicals for use by the public; 

6. 
‘chemical subject to export notification’ means any chemical that is banned or 
severely  restricted  within  the  Union  Community  within  one  or  more  categories  or 
subcategories, and any chemical listed in Part 1 of Annex I that is subject to the PIC 
procedure; 

7. 
‘chemical qualifying  for  PIC  notification’ means any chemical that is banned 
or severely restricted within the Union Community or a Member State within one or 

OJ L 309, 24.11.2009, p. 1. 
OJ  L 123,  24.4.1998,  p. 1.  Directive  as  last  amended  by  Directive  2008/31/EC  of  the  European 
Parliament and of the Council (OJ L 81, 20.3.2008, p. 57). 

6. 

7. 

8. 

30 
31 

EN 

18 

   EN 

                                                 
more  categories.  Chemicals  banned  or  severely  restricted  in  the  Union  Community 
within one or more categories are listed in Part 2 of Annex I; 

9. 

‘chemical subject to the PIC procedure’ means any chemical listed in Annex III 

8. 
to the Convention and in Part 3 of Annex I to this Regulation; 

10. 

9. 

‘banned chemical’ means either of the following: 

(a) 

(b) 

a  chemical  all  uses  of  which  within  one  or  more  categories  or  subcategories 
have  been  prohibited  by  final  regulatory  action  by  the  Union  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  Union  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. 

10. 

‘severely restricted chemical’ means either of the following: 

(a) 

(b) 

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

a  chemical  that  has,  for  virtually  all  uses,  been  refused  for  approval  or  been 
withdrawn  by  industry  either  from  the  Union  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; 

‘chemical  banned  or  severely  restricted  by  a  Member  State’  means  any 
11. 
chemical that is banned or severely restricted by national final regulatory action of a 
Member State; 

‘final  regulatory  action’  means  a  ⌦ legally  binding ⌫  legislative  act  the 

12. 
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; 

12. 

13. 

14. 

15. 

(cid:214) ‘customs territory of the Union’ means the territory as determined in Article 3 of 
Council Regulation (EEC) No 2913/9232.  

16. 

14. 

‘export’ means the following: 

(a) 

the  permanent  or  temporary  export  of  a  chemical  meeting  the  conditions  of 
Article 283(2) of the Treaty; 

32 

OJ L 302, 19.10.1992, p. 1 

EN 

19 

   EN 

                                                 
(b) 

the re-export of a chemical not meeting the conditions of Article 283(2) of the 
Treaty  which  is  placed  under  a  customs  procedure  other  than  the  external 
Union  Community  transit  procedure  for  movement  of  goods  through  the 
customs territory of the Union Community; 

17. 

15. 
‘import’  means  the  physical  introduction  into  the  customs  territory  of  the 
Union Community of a chemical that is placed under a customs procedure other than 
the external Union Community transit procedure for movement of goods through the 
customs territory of the Union Community; 

18. 

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 to determine 
that the chemical be sent out of the customs territory of the Union 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  to 
determine  that the chemical be sent  out of the customs territory of the Union 
Community; 

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

19. 

20. 

‘importer’ means any natural or legal person who at the time of import into the 

17. 
customs territory of the Union 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; 

21. 

19. 

‘other country’ means any country that is not a Party. 

(cid:208) 689/2008 Article 4 

Article 4 
Designated national authorities 

Each  Member  State  shall  designate  the  authority  or  authorities,  hereinafter  ‘the  designated 
national  authority’  or  ‘the  designated  national  authorities’,  to  carry  out  the  administrative 
functions required by this Regulation, unless it has already done so before the entry into force 
of this Regulation. 

It shall inform the Commission of such designation by [OJ: please insert the date: 3 months 
after publication]1 November 2008. 

EN 

20 

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(cid:208) 689/2008 Article 5 (adapted) 
(cid:214) new 

Article 5 
Participation of the Union Community in the Convention 

1. 

2. 

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

12. ⌦ The Commission shall act as a common designated authority ⌫ With regard 
to the Community's participation in the Convention, 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 and in close 
cooperation  and  consultation  with  all  the  designated  national  authorities  of  the 
Member States. 

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

(a) 

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

(ab)  the  submission  to  the  Secretariat  of  the  Convention,  hereinafter  ‘the 
Secretariat’,  of  notifications  of  relevant  final  regulatory  actions  concerning 
chemicals qualifying for PIC notification pursuant to Article 1110; 

(bc)  the  transmission  of  information  concerning  other  final  regulatory  actions 
involving  chemicals  not  qualifying  for  PIC  notification  in  accordance  with 
Article 1211; 

(cd)  the receiving of information from the Secretariat more generally. 

The  Commission  shall  also  provide  the  Secretariat  with  Union  Community  import 
responses for chemicals subject to the PIC procedure pursuant to Article 1312. 

In  addition,  the  Commission  shall  coordinate  the  Union  Community  input  on  all 
technical issues relating 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; 

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

(d)  other subsidiary bodies. 

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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. 

3. 

23.  The  Commission  and  the  Member  States  shall  take  the  necessary  initiatives  to 
ensure appropriate (cid:214) coordination  representation of the Community in the various 
bodies implementing the Convention. 

(cid:216) new 

Article 6 
Tasks of the European Chemicals Agency  

1. 

The Agency shall, in addition to the tasks allocated to it under Articles 7, 8, 9, 10, 11, 
13, 14, 18, 19, 20, 21, 22 and 25 of this Regulation, carry out the following tasks: 

(a)  maintain,  further  develop  and  regularly  update  the  Database  on  Export  and 

Import of Dangerous Chemicals ("the Database");  

(b)  make the Database publicly available on its website; 

(c)  where appropriate, provide, with the agreement of the Commission, assistance 
and  technical  and  scientific  guidance  and  tools  for  the  industry  in  order  to 
ensure the effective application of this Regulation;  

(d)  provide  the  designated  national  authorities,  with  the  agreement  of  the 
Commission, with assistance and technical and scientific guidance in order to 
ensure the effective application of this Regulation;  

(e)  where  requested  by  the  Commission  and  in  cooperation  with  Member  States, 
prepare  decision  guidance  documents  referred  to  in  Article 7(3)  of  the 
Convention and other technical documents related to the implementation of the 
Convention which shall be subject to approval by the Commission; 

(f) 

upon request, provide the Commission with technical and scientific input and 
assist it in order to ensure the effective implementation of this Regulation; 

(g)  upon request, provide the Commission with technical and scientific input and 
assist it in exercising its role as the common designated authority of the Union. 

2. 

The Secretariat of the Agency shall carry out the tasks allocated to the Agency under 
this Regulation. 

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(cid:208) 689/2008 Article 6 
(cid:214) new 

Article 76 
Chemicals subject to export notification, chemicals qualifying for PIC notification, and 
chemicals subject to the PIC procedure 

1. 

2. 

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 as Parts 1, 2 and 3 of Annex I. 

The chemicals listed in Part 1 of Annex I shall be subject to the export notification 
procedure  laid  down  in  Article 87,  with  detailed  information  being  given  on  the 
identity  of  the  substance,  on  the  use  category  and/or  subcategory  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  Annex I  shall,  in  addition  to  being  subject  to  the 
export notification procedure laid down in Article 87, qualify for the PIC notification 
procedure  set  out  in  Article 1110,  with  detailed  information  being  given  on  the 
identity of the substance and on the use category. 

The chemicals listed in Part 3 of Annex I 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. 

3. 

The lists referred to in paragraph 2 shall be made available to the public by (cid:214) means 
of the Agency's Database available on its website  electronic means. 

(cid:208) 689/2008 Article 7 (adapted) 
(cid:214) new 

Article 87 
Export notifications forwarded to Parties and other countries 

1. 

2. 

In the case of substances listed in Part 1 of Annex I or ⌦ mixtures ⌫ preparations 
containing  such  substances  in  a  concentration  that  (cid:214) triggers   could  trigger 
labelling  obligations  under  Directive  1999/45/EC  (cid:214) and,  where  applicable,  under 
Regulation  (EC)  No  1272/2008   irrespective  of  the  presence  of  any  other 
substances, paragraphs 2 to 8 shall apply. 

When  an  exporter  is  due  to  export  a  chemical  referred  to  in  paragraph 1  from  the 
Union Community to a Party or other country for the first time on or after the date on 
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 
⌦ 20 working ⌫  30 days  before  the  export  of  the  chemical  is  due  to  take  place. 

EN 

23 

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Thereafter  the  exporter  shall  notify  the  designated  national  authority  of  the  first 
export  of  such  chemical  each  calendar  year  no  later  than (cid:214) 20 working   15  days 
before the export takes place. The notifications shall comply with the requirements 
set  out  in  Annex II  (cid:214) and  shall  be  made  available  by  means  of  the  Agency's 
Database on its website  . 

The  designated  national  authority  shall  check  compliance  of  the  information  with 
Annex II  and  promptly  forward  the  notification  received  from  the  exporter  to  the 
(cid:214) Agency within 5 working days  Commission. 

The (cid:214) Agency  Commission shall take the measures necessary to ensure that (cid:214) , 
on behalf of the Commission, transmit the notification to  the designated national 
authority  of  the  importing  Party  or  the  appropriate  authority  of  the  importing  other 
country  and  ⌦ take  the  measures  necessary  to  ensure  that  they ⌫  receive 
⌦ that ⌫  notification  no  later  than  ⌦ 10 working ⌫  15  days  before  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. 

(cid:214) The Agency shall register each Each export notification shall be registered and 
⌦ assign it ⌫ assigned an export a reference identification number in ⌦ its ⌫ a 
Database.  database  at  the  Commission,  (cid:214) The  Agency   ⌦ shall  also  make 
available to the public and the designated national authorities of the Member States, 
as appropriate, ⌫ and an updated list of the chemicals concerned and the importing 
Parties and other countries for each calendar year (cid:214) by means of the Database on its 
website   shall  be  kept  available  to  the  public  and  distributed  to  the  designated 
national authorities of the Member States as appropriate. 

If the (cid:214) Agency  Commission does not receive from the importing Party or other 
country an acknowledgement of receipt of the first export notification given after the 
chemical  is  included  in  the  Part  1  of  Annex I  within ⌦ 20 working ⌫  30 days  of 
the dispatch of such notification, it shall (cid:214) , on behalf of the Commission,  submit 
a  second  notification.  The  (cid:214) Agency   Commission  shall  (cid:214) ,  on  behalf  of  the 
Commission,   make  reasonable  efforts  to  ensure  that  the  designated  national 
authority  of  the  importing  Party  or  the  appropriate  authority  of  the  importing  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 Union Community legislation concerning 
the  marketing,  use  or  labelling  of  the  substances  in  question  or  whenever  the 
composition  of  the  ⌦ mixture ⌫  preparation  in  question  changes  so  that  the 
labelling  of  such  ⌦ mixture ⌫  preparation  is  altered.  The  new  notification  shall 
comply  with  the  requirements  set  out  in  Annex II  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 
(cid:214) the duly justified request of the exporter or the importing Party or other country 
and at  the discretion of the designated national authority of the exporting Member 
State, in consultation with the Commission (cid:214) assisted by the Agency  . 

3. 

4. 

5. 

EN 

24 

   EN 

6. 

(cid:214) Without prejudice to the obligations set out in paragraphs 2 and 3 of Article 19, 
the   The  obligations  set  out  in  paragraphs 2,  3  and  4  ⌦ of  this  Article ⌫  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  the 
Secretariat with a response in accordance with Article 10(2) of the Convention 
indicating whether or not it consents to import of the chemical; 

(c) 

the Commission has been informed of that response by the Secretariat and has 
forwarded that information to the Member States (cid:214) and the Agency ; 

⌦ However, the obligations set out in paragraphs 2, 3 and 4 of this Article shall not 
cease ⌫ 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. 

(cid:214) Without prejudice to the obligations set out in paragraphs 2 and 3 of Article 19, 
the   The  obligations  set  out  in  paragraphs 2,  3  and  4  ⌦ of  this  Article ⌫  shall 
also cease when the following conditions are fulfilled: 

(a) 

(b) 

the  designated  national  authority  of  the  importing  Party  or  the  appropriate 
authority  of  the  importing  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 
designated  national  authority  of  the  importing  Party  or  the  appropriate 
authority  of  the  importing  other  country  and  has  forwarded  it  to  the  Member 
States (cid:214) and the Agency, which   and  made  it  available (cid:214) by  means  of  the 
Database on its website  on the Internet. 

The Commission, the relevant designated national authorities of the Member States, 
(cid:214) the  Agency   and  the  exporters  shall  provide  importing  Parties  and  other 
countries  with  available  additional  information  concerning  the  exported  chemicals, 
when requested. 

Member States may establish systems obliging exporters to pay an administrative fee 
for  each  export  notification  given  and  for  each  request  for  explicit  consent  made, 
corresponding  to  the  costs  ⌦ they  incur  in ⌫  to  them  of  carrying  out  the 
procedures set out in paragraphs 2, 3 and 4 of this Article and in Article 1413(3), (6) 
and (7). 

(cid:208) 689/2008 Article 8 
(cid:214) new 

7. 

8. 

Article 98 
Export notifications received from Parties and other countries 

1. 

Export notifications received by the (cid:214) Agency  Commission from the designated 
national  authorities  of  Parties  or  the  appropriate  authorities  of  other  countries 

EN 

25 

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concerning the export to the Union 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 
(cid:214) by means of the Agency's Database on its website  by electronic means through 
the database maintained by the Commission. 

The  (cid:214) Agency   Commission  shall  (cid:214) ,  on  behalf  of  the  Commission,  
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  (cid:214) by  the  Agency   together  with  all 
available  information.  Other  Member  States  shall  be  entitled  to  receive  copies  on 
request. 

2. 

Should  (cid:214) the  Commission  or   the  designated  national  authorities  of  the  Member 
States  receive  any  export  notifications  either  directly  or  indirectly  from  the 
designated  national  authorities  of  Parties  or  the  appropriate  authorities  of  other 
countries,  they  shall  immediately  forward  those  notifications  to  the  (cid:214) Agency  
Commission together with all available information. 

(cid:208) 689/2008 Article 9 (adapted) 
(cid:214) new 

Article 109 
Information on export and import of chemicals 

1. 

Each exporter of: 

(a-)  substances listed in Annex I, 

(b-)  ⌦ mixtures ⌫  preparations  containing  such  substances  in  a  concentration 
that  (cid:214) triggers   could 
labelling  obligations  under  Directive 
1999/45/EC (cid:214) and, where applicable, under Regulation (EC) No 1272/2008  
irrespective of the presence of any other substances, or 

trigger 

(c-)  articles  containing  substances  listed  in  Parts  2  or  3  of  Annex I  in  unreacted 
form  or  ⌦ mixtures ⌫  preparations  containing  such  substances  in  a 
concentration  that  (cid:214) triggers   could  trigger  labelling  obligations  under 
Directive  1999/45/EC  (cid:214) and,  where  applicable,  under  Regulation  (EC)  No 
1272/2008  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  regarding  the  quantity  of  the  chemical,  as  a  substance  and  as 
contained  in  ⌦ mixtures ⌫  preparations  or  in  articles,  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.  That  information  shall  list  separately  exports  pursuant  to 
Article 1413(7). 

EN 

26 

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2. 

3. 

1. 

2. 

3. 

4. 

5. 

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

Upon  request  from  the  Commission  or  the  designated  national  authority  of  its 
Member  State  (cid:214) or  the  Agency ,  the  exporter  or  importer  shall  provide  any 
additional  information  relating  to  chemicals  that  is  necessary  to  implement  this 
Regulation. 

information 

Each  Member  State  shall  provide  the  (cid:214) Agency   Commission  each  year  with 
in  accordance  with  Annex III.  The  (cid:214) Agency  
aggregated 
Commission shall summarise that  information at Union Community level and  shall 
make  the  non-confidential  information  publicly  available  on  its  ⌦ Database ⌫ 
database via the Internet. 

(cid:208) 689/2008 Article 10 (adapted) 
(cid:214) new 

Article 1110 
Notification of banned or severely restricted chemicals under the Convention 

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

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 Union Community 
regulatory  action  banning  or  severely  restricting  the  chemical,  and  no  later  than  90 
days after the date on which the final regulatory action must be applied. 

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

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 IV can be met, and the severity of the 
risks presented by the chemical, in particular for developing countries. 

⌦ Where ⌫ When a chemical qualifies for PIC notification, but the information is 
insufficient to meet the requirements of Annex IV, 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, within 60 days of the request. 

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 must be applied. 

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

EN 

27 

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6. 

7. 

8. 

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

The Member States (cid:214) and the Agency  shall, upon request, assist the Commission 
as necessary in compiling that information. 

The  Commission  shall  forward  immediately  to  the  Member  States  (cid:214) and  the 
Agency   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  (cid:214) and  the  Agency ,  the  need  to  propose  measures  at  Union 
Community level in order to prevent any unacceptable risks to human health or the 
environment within the Union Community. 

Where a Member State takes national final regulatory action in accordance with the 
relevant Union 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  of  that  information 
having been made available 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 to the Member 
State which submitted the national final regulatory action. After consideration of the 
comments,  the  submitting  Member  State  shall  inform  the  Commission  whether  the 
latter shall: 

(a) 

notify the Secretariat, pursuant to this Article, or 

(b)  provide the information to the Secretariat, pursuant to Article 1211. 

(cid:208) 689/2008 Article 11 (adapted) 

Article 1211 

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

⌦ Where ⌫  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 the second indent of Article 1110(8), the 
Commission  shall  provide  the  Secretariat  with  information  concerning  the  relevant  final 
regulatory  actions,  so  that  that  information  can  be  disseminated  to  other  Parties  to  the 
Convention as appropriate. 

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(cid:208) 689/2008 Article 12 
(cid:214) new 

Article 132 
Obligations in relation to imports of chemicals 

1. 

The  Commission  shall  immediately  forward  to  the  Member  States  (cid:214) and  the 
Agency  any decision guidance documents which it receives from the Secretariat. 

The  Commission  shall,  in  accordance  with  the  advisory  procedure  referred  to  in 
Article 294(2),  take  an  import  decision,  in  the  form  of  a  final  or  interim  import 
response  on  behalf  of  the  Union  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  Union 
Community  legislation,  the  Commission  shall  revise  the  import  decision  in 
in  Article 294(2)  and 
to 
accordance  with 
communicate the revised import decision to the Secretariat. 

the  advisory  procedure  referred 

In  the  case  of  a  chemical  banned  or  severely  restricted  by  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  Union  Community  shall  make  the 
import  decisions  under  paragraph 1  available  to  those  concerned  within  its 
competence,  in  accordance  with  its  legislative  or  administrative  measures.  (cid:214) The 
Agency shall make the import decisions under paragraph 1 publicly available on its 
Database.  

Where  appropriate,  the  Commission  shall  evaluate,  in  close  cooperation  with  the 
Member  States  (cid:214) and  the  Agency ,  the  need  to  propose  measures  at  Union 
Community level in order to prevent any unacceptable risks to human health or the 
environment within the Union Community, taking into account the information given 
in the decision guidance document. 

2. 

3. 

4. 

5. 

6. 

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(cid:208) 689/2008 Article 13 (adapted) 
(cid:214) new 

Article 143 
Obligations in relation to exports of chemicals other than export notification requirements 

1. 

2. 

3. 

4. 

5. 

6. 

The Commission shall immediately forward to the Member States (cid:214) , the Agency  
and European industry associations the 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 importing Parties regarding import conditions 
applicable  to  those  chemicals.  It  shall  also  immediately  forward  to  the  Member 
States (cid:214) and the Agency  information concerning any cases of failure to transmit a 
response  in  accordance  with  Article 10(2)  of  the  Convention.  The  (cid:214) Agency  
Commission ⌦ shall assign each import decision a reference identification number 
and keep ⌫ shall keep all information regarding import decisions, which shall each 
be  assigned  an  import  decision  reference  identification  number,  available  in  its 
Database  database,  which  shall  be  publicly  available  on  ⌦ its  website ⌫  the 
Internet, and provide anyone with that information upon request. 

The Commission shall assign each chemical listed in Annex I a classification in the 
European Union's Community's Combined Nomenclature. Those classifications shall 
be  revised  as  necessary  in  the  light  of  any  changes  made  in  the  World  Customs 
Organization's  Harmonized  System  Nomenclature  or  in  the  European  Union's 
Community's Combined 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  that  response 
under paragraph 1. 

The Commission (cid:214) , assisted by the Agency,  and the Member States shall advise 
and assist importing Parties, upon request and as appropriate, ⌦ in obtaining ⌫ to 
obtain further information ⌦ needed to prepare ⌫ to help them to make a response 
to the Secretariat concerning the import of a given chemical. 

Substances  listed  in  Parts  2  or  3  of  Annex I  or  ⌦ mixtures ⌫  preparations 
containing  such  substances  in  a  concentration  that  (cid:214) triggers   could  trigger 
labelling  obligations  under  Directive  1999/45/EC  (cid:214) and,  where  applicable,  under 
Regulation  (EC)  No  1272/2008   irrespective  of  the  presence  of  any  other 
substances shall not be exported unless either of the following conditions is fulfilled: 

(a) 

explicit consent to import has been sought and received by the exporter through 
his  designated  national  authority  in  consultation  with  the  Commission  (cid:214) , 
assisted  by  the  Agency,   and  the  designated  national  authority  of  the 
importing Party or an appropriate authority in an importing other country; 

EN 

30 

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(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 to be exported to OECD 
countries, the designated national authority of the exporter may, (cid:214) at the request of 
the  exporter,   in  consultation  with  the  Commission  and  on  a  case-by-case  basis, 
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 in that OECD 
country. 

Where  explicit  consent  has  been  sought  pursuant  to  point  (a),  if  the  (cid:214) Agency  
Commission  or the  designated  national authority of the  exporter has not  received a 
response  to  ⌦ the ⌫  its  request  within  30 days,  the  (cid:214) Agency   Commission 
shall (cid:214) , on behalf of the Commission,  send a reminder (cid:214) unless the Commission 
or  the  designated  national  authority  received  a  response  and  forwarded  it  to  the 
Agency . Where appropriate, if there is still no response within a further 30 days, 
the (cid:214) Agency  Commission may send further reminders as necessary. 

7. 

In  the  case  of  chemicals  listed  in  Parts  2  or  3  of  Annex I,  the  designated  national 
authority of the exporter may, in consultation with the Commission (cid:214) assisted by the 
Agency  and on a case-by-case basis, decide that the export may proceed if, after 
all  reasonable  efforts,  no  response  to  a  request  for  explicit  consent  pursuant  to 
paragraph 6(a) has been received within 60 days and there is evidence from official 
sources in the importing Party or other country that the chemical has been licensed, 
registered or authorised (cid:214) or that it has in the last 5 years been used in, or imported 
into the importing Party or importing other country and no regulatory action has been 
taken to prohibit its use.  

When deciding on the export of chemicals listed in Part 3 of Annex I, the designated 
national authority in consultation with the Commission (cid:214) assisted by the Agency  
shall consider the possible impact on human health or the environment of the use of 
the chemical in the importing Party or other country. 

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 shall be for a maximum period of 12 months, 
upon expiry of which explicit consent shall be required. 

In the cases referred to in point (a) of this paragraph, exports may, however, continue 
after the end of the relevant period, pending a response to a new request for explicit 
consent, for an additional period of 12 months. 

All new requests shall be channelled through the Commission. 

EN 

31 

   EN 

9. 

10. 

11. 

The  (cid:214) Agency   Commission  shall  register  all  requests  for  explicit  consent, 
responses  obtained  and  waivers  granted  in  its  Database  database.  Each  explicit 
consent obtained or waived shall be assigned ⌦ a ⌫ an explicit consent reference 
identification number and shall be listed with all relevant information concerning any 
conditions  attached,  ⌦ such  as ⌫  validity  dates,  etc.  The  non-confidential 
information  shall  be  made  publicly  available  on  the  (cid:214) Agency's  Database  
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  that  impracticable.  In  particular,  in  the  case  of 
pesticides,  exporters  shall  ensure  that  the  size  and  packaging  of  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  pesticides  exported  comply  with  the  purity  specification  laid  down  in  Union 
Community legislation. 

(cid:208) 689/2008 Article 14 (adapted) 
(cid:214) new 

Article 154 
Export of certain chemicals and articles containing chemicals 

1. 

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 87 ⌦ if they contain any of the following: ⌫  

⌦ a) substances listed in Parts 2 or 3 of Annex I in unreacted form; ⌫  

⌦ b) mixtures containing such substances in a concentration that ⌫ (cid:214) triggers  
⌦ labelling  obligations  under  Directive  1999/45/EC ⌫  (cid:214) and,  where 
applicable,  under  Regulation  (EC)  No  1272/2008   ⌦ irrespective  of  the 
presence of any other substances. ⌫  

2. 

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

EN 

32 

   EN 

 
1. 

2. 

3. 

4. 

1. 

(cid:208) 689/2008 Article 15 
(cid:214) new 

Article 165 
Information on transit movements 

Parties  to  the  Convention  requiring  information  concerning  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  30 days  before  the  first  transit  movement 
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  (cid:214) with  a  copy  to  the  Agency,   the  information  received  from  the 
exporter under paragraph 2 together with any additional information available. 

The  Commission  shall  forward  the  information  received  under  paragraph 3  to  the 
designated  national  authorities  of  Parties  to  the  Convention  which  requested  that 
information, together with any additional information available, no later than 15 days 
before the first transit movement and prior to any subsequent transit movement. 

(cid:208) 689/2008 Article 16 (adapted) 
(cid:214) new 

Article 176 
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,  Regulation  (EC)  No  1107/2009,  Directive  91/414/EEC  and  Directive 
98/8/EC  (cid:214) and,  where  applicable,  Regulation  (EC)  No  1272/2008,   or  any  other 
⌦ relevant ⌫ specific Union Community legislation. 

(cid:216) new 

By  way  of  derogation  from  point  (b)  of  Article  1(2)  of  Regulation  (EC)  No 
1272/2008, chemicals that are intended for export and subject to customs supervision 
which do not undergo any treatment or processing and are in temporary storage or in 
a free zone or free warehouse with a view to re-exportation, shall be subject to the 
measures on packaging and labelling established in, or pursuant to, Regulation (EC) 
No 1272/2008. 

EN 

33 

   EN 

 
 
 
(cid:208) 689/2008 Article 16 (adapted) 

The  first  ⌦ two ⌫  subparagraphs  ⌦ of  this  paragraph ⌫  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. 

A  safety  data  sheet  in  accordance  with  Regulation  (EC)  No 1907/2006  of  the 
European Parliament  and  of  the  Council of 18 December  2006 on the Registration, 
Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a 
European Chemicals Agency33 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. 

2. 

3. 

4. 

(cid:208) 689/2008 Article 17 (adapted) 
(cid:214) new 

Article 187 
Obligations of the authorities of the Member States and exporters for controlling imports and 
exports 

1. 

2. 

3. 

33 

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, unless it has already done so before the entry into force of this Regulation. 

The Commission, and the Member States (cid:214) and the Agency  shall act in a targeted 
and coordinated way in monitoring exporters' compliance with this Regulation.  

The Forum for Exchange of Information on Enforcement established by Regulation 
(EC)  No  1907/2006  shall  be  used  to  coordinate  activities  of  the  Member  States' 
authorities responsible for enforcement of this Regulation.  

(cid:216) new 

Each  Member  State  shall,  in  its  regular  reports  on  the  operation  of  procedures 
pursuant to Article 2221(1), include details of the activities of its authorities in that 
regard. 

(cid:208) 689/2008 Article 17 

OJ L 396, 30.12.2006, p. 1. Corrected version in OJ L 136, 29.5.2007, p. 3. Regulation as amended by 
Council Regulation (EC) No 1354/2007 (OJ L 304, 22.11.2007, p. 1). 

EN 

34 

   EN 

 
 
 
 
                                                 
1. 

2. 

3. 

4. 

1. 

(cid:208) 689/2008 Article 17 (adapted) 
(cid:214) new 

(cid:214) Article 19 
Obligations of exporters for controlling imports and exports  

Exporters (cid:214) of chemicals subject to the obligations set out in paragraphs 2 and 4 of 
Article  8   shall  provide ⌦ the  applicable  reference  identification  numbers ⌫  in 
their  export  declaration  (box  44  of  the  Single  Administrative  Documents  or 
corresponding  data  element  in  an  electronic  export  declaration)  as  referred  to  in 
Article  161(5)  of  Council  Regulation  (EEC)  No  2913/92  of  12 October  1992 
establishing the  Community Customs  Code34 the applicable  reference  identification 
numbers  referred  to  in  Article 7(2)  or  Article 13(1)  or  (9)  of  this  Regulation  as 
appropriate confirming compliance with the obligations to which they relate. 

(cid:216) new 

Exporters  of  chemicals  exempted  by  paragraphs  5  or  6  of  Article  8  from  the 
obligations  set  out  in  paragraphs  2  and  4  of  that  Article  shall  obtain  a  reference 
identification  number  using  the  Database  available  on  the  Agency's  website  and 
provide that reference identification number in their export declaration. 

Where  no  export  declaration  is  required,  all  exporters  shall  provide  the  reference 
identification  number  in  the  summary  declaration  lodged  at  the  customs  office  of 
exit. 

Where  requested  by  the  Agency,  exporters  shall  use  the  Agency's  Database  for  the 
submission of information required for the fulfilment of their obligations under this 
Regulation. 

(cid:208) 689/2008 Article 19 
(cid:214) new 

Article 2019 
Exchange of information 

The  Commission  (cid:214) ,  assisted  by  the  Agency,   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  (cid:214) and  the  Agency   as 
necessary, shall, as appropriate, ensure: 

34 

OJ L 302, 19.10.1992, p. 1. Regulation as last amended by Regulation (EC) No 1791/2006 (OJ L 363, 
20.12.2006, p. 1). 

EN 

35 

   EN 

 
 
 
                                                 
2. 

3. 

(a) 

(b) 

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

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

The  Commission,  and  the  Member  States  (cid:214) and  the  Agency   shall  protect  any 
confidential information received from a Party or other country as mutually agreed. 

As  regards  the  transmission  of  information  under  this  Regulation,  and  without 
prejudice to Directive 2003/4/EC of the European Parliament and of the Council35 of 
28 January  2003  on  public  access  to  environmental  information,  the  following 
information at least shall not be regarded as confidential: 

(a) 

the information specified in Annex II and Annex IV; 

(b) 

the information contained in safety data sheets referred to in Article 176(3); 

(c) 

the expiry date of a chemical; 

(d) 

the production date of a chemical; 

(e) 

information 
classification, the nature of the risk and the relevant safety advice; 

precautionary  measures, 

concerning 

including 

hazard 

(f) 

the summary results of toxicological and ecotoxicological tests; 

(g) 

information  concerning  handling  packaging  after  chemicals  have  been 
removed. 

A  compilation  of  the  information  transmitted  shall  be  prepared  regularly  by  the 
(cid:214) Agency  Commission on the basis of the contributions by Member States (cid:214) and 
the Commission . 

(cid:208) 689/2008 Article 20 (adapted) 
(cid:214) new 

Article 2120 
Technical assistance 

The  Commission,and  the  designated  national  authorities  of  the  Member  States  (cid:214) and  the 
Agency   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 lifecycles. 

35 

OJ L 41, 14.2.2003, p. 26. 

EN 

36 

   EN 

 
                                                 
In  particular,  and  with  a  view  to  enabling  those  countries  to  implement  the  Convention, 
technical  assistance  shall  be  promoted  by  means  of  the  provision  of  technical  information 
concerning chemicals, the promotion of the exchange of experts, support for the establishment 
or maintenance of designated national authorities and the provision of technical expertise for 
the identification of hazardous pesticide formulations and for the preparation of notifications 
to the Secretariat. 

The Commission and the Member States shall actively participate in (cid:214) international activities 
in  capacity-building  in  chemicals  management   the  Information  Network  on  Capacity 
Building  set  up  by  the  Intergovernmental  Forum  on  Chemical  Safety,  by  providing 
information  concerning  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. 

(cid:208) 689/2008 Article 21 
(cid:214) new 

Article 2221 
Monitoring and reporting 

1. 

2. 

3. 

Member  States  (cid:214) and  the  Agency   shall  regularly  forward  to  the  Commission 
information  concerning  the  operation  of  the  procedures  provided  for  in  this 
Regulation, including customs controls, infringements, penalties and remedial action, 
(cid:214) as appropriate . 

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 incorporate it in a 
synthesis  report  integrating  the  information  provided  by  the  Member  States  (cid:214) and 
the  Agency   under  paragraph 1.  A  summary  of  that  report,  which  shall  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 (cid:214) , the Agency  and the Commission shall comply with relevant obligations 
to protect the confidentiality of data and ownership. 

(cid:208) 689/2008 Article 22 (adapted) 
(cid:214) new 

Article 2322 
Updating annexes 

1. 

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

EN 

37 

   EN 

 
 
2. 

3. 

4. 

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

When  determining  whether  a  final  regulatory  action  at  Union  Community  level 
constitutes a ban or a severe restriction such that the chemical concerned qualifies for 
PIC notification under Article 1110, the effect of that action shall be assessed at the 
level of the categories ‘pesticides’ and ‘industrial chemicals’. If the final regulatory 
action bans or severely restricts a chemical within either of the categories it shall also 
be included in Part 2 of Annex I. 

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

(cid:214) The  Commission  may,  for  the  purpose  of  adapting  this  Regulation  to  technical 
progress,  adopt,  by  means  of  delegated  acts  in  accordance  with  Article 26,  the 
following  measures:   The  following  measures,  designed  to  amend  non-essential 
elements  of  this  Regulation,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 24(3): 

(a)  ⌦ inclusion of ⌫ measures to include a chemical in Parts 1 or 2 of Annex I 
pursuant to paragraph 2 following final regulatory action at Union Community 
level  ⌦ and  amendments  of  Annex I,  including  modifications  to  existing 
entries ⌫ ; 

(b)  ⌦ inclusion  of ⌫  measures  to  include  a  chemical  that  is  subject  to 
Regulation (EC) No 850/2004 of the European Parliament and of the Council36 
in Part 1 of Annex V; 

(c) 

other measures to amend Annex I, including modifications to existing entries; 

(cd)  ⌦ inclusion of ⌫ measures to include a chemical already subject to an export 

ban at Union Community level in Part 2 of Annex V; 

(df)  ⌦ modifications to ⌫ measures to modify existing entries in Annex V.; 

(e)  ⌦ amendments of ⌫ measures to amend Annexes II, III, IV and VI.; 

(cid:208) 689/2008 Article 23 

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. 

36 

OJ L 158, 30.4.2004, p. 7. 

EN 

38 

   EN 

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

(cid:216) new 

Article 24 
The budget of the Agency 

1. 

For the purposes of this Regulation, the revenues of the Agency shall consist of: 

(a) 

a  subsidy  from  the  Union,  entered  in  the  general  budget  of  the  Union 
(Commission Section); 

(b) 

any voluntary contribution from the Member States. 

2. 

3. 

Revenues  and  expenditure  for  activities  under  this  Regulation  and  those  relating  to 
activities  under  other  Regulations  shall  be  dealt  with  separately,  through  different 
sections in the Agency’s budget. 

The revenues of the Agency referred to in paragraph 1 shall be used for carrying out 
its tasks under this Regulation. 

The Commission shall examine whether it is appropriate for the Agency to charge a 
fee for the services provided to exporters within five years of the date referred to in 
the second subparagraph of Article 33 and, if necessary, submit a relevant proposal. 

(cid:216) new 

Article 25 
Formats and software for submission of information to the Agency 

The  Agency  shall  specify  formats  and  software  packages  and  make  them  available  free  of 
charge  on  its  website  for  any  submission  of  information to the Agency. Member States and 
other  parties  subject  to  this  Regulation  shall  use  those  formats  and  packages  in  their 
submissions to the Agency pursuant to this Regulation. 

(cid:216) new 

Article 26 
Exercise of the delegation 

1. 

2. 

3. 

The powers to adopt the delegated acts referred to in Article 23(4) shall be conferred 
on the Commission for an indeterminate period of time. 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 

The powers to adopt delegated acts are conferred on the Commission subject to the 
conditions laid down in Articles 27 and 28. 

EN 

39 

   EN 

 
 
 
(cid:216) new 

Article 27 
Revocation of the delegation 

The delegation of power referred to in Article 23(4) may be revoked at any time by 
the European Parliament or by the Council. 

The institution which has commenced an internal procedure for deciding whether to 
revoke the delegation of power shall endeavour to inform the other institution and the 
Commission  within  a  reasonable  time  before  the  final  decision  is  taken,  indicating 
the delegated powers which would be subject to revocation and possible reasons for a 
revocation. 

The decision of revocation shall put an end to the delegation of powers specified in 
that  decision.  It  shall  take  effect  immediately  or  at  a  later  date  specified  therein.  It 
shall  not  affect  the  validity  of  the  delegated  acts  already  in  force.  It  shall  be 
published in the Official Journal of the European Union. 

(cid:216) new 

Article 28 
Objections to delegated acts 

The European Parliament and the Council may object to the delegated act within a 
period of two months from the date of notification. At the initiative of the European 
Parliament or the Council this period shall be extended by one month. 

If,  on  expiry  of  that  period,  neither  the  European  Parliament  nor  the  Council  has 
objected  to  the  delegated  act  it  shall  be  published  in  the  Official  Journal  of  the 
European Union and shall enter into force at the date stated therein. 

The  delegated  act  may  be  published  in  the Official Journal of the European Union 
and enter into force before the expiry of that period if the European Parliament and 
the  Council  have  both  informed  the  Commission  of  their  intention  not  to  raise 
objections. 

If the European Parliament or the Council objects to a delegated act, it shall not enter 
into  force.  The  institution  which  objects  shall  state  the  reasons  for  objecting  to  the 
delegated act. 

1. 

2. 

3. 

1. 

2. 

3. 

EN 

40 

   EN 

 
 
(cid:208) 689/2008 Article 24 (adapted) 
(cid:214) new 

Article 294 
Committee 

1. 

2. 

3. 

The  Commission  shall  be  assisted  by  the  committee  established  by  Article 133  of 
Regulation (EC) No 1907/2006. (cid:214) That committee shall be a committee within the 
meaning of Regulation (EU) No 182/2011.  

Where reference is made to this paragraph, Article 3 and Article 7 (cid:214) of Regulation 
(EU)  No  182/2011   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. 

(cid:216) new 

Article 30 
Amendments to Annexes under Regulation (EC) No 689/2008 

The Commission shall ensure, by means of delegated acts in accordance with Article 26, that 
all  amendments  to  the  Annexes  to  Regulation  (EC)  No  689/2008  adopted  prior  to  1  April 
2013 are incorporated in this Regulation by 31 March 2013. 

(cid:208) 689/2008 Article 18 (adapted) 

Article 3118 
Penalties 

Member  States  shall  ⌦ lay  down  the  rules  on ⌫  determine  the  penalties  applicable  to 
infringements  of  the  provisions  of  this  Regulation  and  ⌦ shall ⌫  take  all  measures 
necessary to ensure correct implementation of these provisions. The penalties ⌦ provided for 
must ⌫  shall  be  effective,  proportionate  and  dissuasive.  If  they  have  not  already  done  so 
before the entry into force of this Regulation, Member States shall notify ⌦ those provisions 
to ⌫  the  Commission  of  those  measures  by  [OJ:  please  insert  the  date:  1  year  after 
publication]  1 August  2009.⌦ at  the  latest  and ⌫  They  shall  also  notify  it  ⌦ without 
delay ⌫ of any ⌦ subsequent amendment affecting them ⌫ further modifications as soon 
as possible after their adoption. 

Member States shall make all information regarding penalties available upon request. 

EN 

41 

   EN 

 
 
 
(cid:208) 689/2008 Article 25 (adapted) 
(cid:214) new 

Article 3225 
 (cid:214) Repeal  References to Regulation (EC) No 304/2003 

(cid:214) Regulation (EC) No 689/2008 shall be repealed with effect from 31 March 2013.  

References to Regulation (EC) No ⌦ 689/2008 ⌫ 304/2003 shall be construed as references 
to this Regulation (cid:214) and shall be read in accordance with the correlation table in Appendix 
1 . 

(cid:208) 689/2008 Article 26 (adapted) 
(cid:214) new 

Article 3326 
Entry into force 

This Regulation shall enter into force on the (cid:214) twentieth  day following ⌦ that of ⌫ its 
publication in the Official Journal of the European Union. 

Article 17(2), however, shall apply as from 1 November 2008. 

(cid:214) This Regulation shall apply as from 1 April 2013.   

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

⌦ It shall be binding in its entirety and directly applicable in all Member States. ⌫  

Done at […], 

For the European Parliament 
The President 

For the Council 
The President 

EN 

42 

   EN 

 
 
(cid:208) 689/2008 Annex I (adapted) 
(cid:206)1 15/2010 Art. 1 and Annex .1(a) 
(cid:206)2 196/2010 Art. 1 and Annex .1(a) 
(cid:206)3 196/2010 Art. 1 and Annex .1(b) 
(cid:206)4 15/2010 Art. 1 and Annex .1(b) 
(cid:206)5 15/2010 Art. 1 and Annex .2(a) 
(cid:206)6 196/2010 Art. 1 and Annex .2(b) 
(cid:206)7 196/2010 Art. 1 and Annex .2(a) 
(cid:206)8 15/2010 Art. 1 and Annex .2(b) 
(cid:206)9 196/2010 Art. 1 and Annex .3 

ANNEX I 

LIST OF CHEMICALS 

(referred to in Article 76) 

PART 1 

List of chemicals subject to export notification procedure 

(referred to in Article 87) 

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 87(2), 
(3)  and  (4)  shall  not  apply  provided  that  the  conditions  laid  down  in  ⌦ points ⌫  Article  7(6)  (b)  and  (c)  ⌦ of  Article  8(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 Union's Community's final 
regulatory action, those 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 

Subcategory (*)  Use limitation  Countries for which no 

EN 

43 

EN 

 
  
 
 
 
1,1,1-Trichloroethane 

71-55-6 

200-756-3 

29031910 

i(2) 

1,2-Dibromoethane (Ethylene dibromide) # 

106-93-4 

203-444-5 

29033100 

p(1)-p(2) 

b 

b-b 

1,2-Dichloroethane (ethylene dichloride) # 

107-06-2 

203-458-1 

29031500 

p(1)-p(2) 

b-b 

(**) 

notification is required 

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

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

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

10061-01-5 

233-195-8 

29032900 

p(1)-p(2) 

i(2) 

b 

b-b 

(cid:206)1 1,3-dichloropropene37  

(cid:206)1 542-75-
6  

(cid:206)1 208-
826-5  

(cid:206)1 29032
900  

(cid:206)1 p(1)  

(cid:206)1 b  

2-aminobutane 

13952-84-6 

237-732-7 

29211980 

p(1)-p(2) 

b-b 

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

(cid:206)2 2-Naphthyloxyacetic acid  

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

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

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

29214500 

i(1) 

i(2) 

b 

b 

(cid:206)2 120-23-
0  

(cid:206)2 204-
380-0  

(cid:206)2 29189
990  

(cid:206)2 p(1)  

(cid:206)2 b  

93-76-5 and 
others 

202-273-3 
and others 

29189100 

p(1)-p(2) 

b-b 

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

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

92-67-1, 

202-177-1 

29214980 

i(1) 

b 

37 

This entry does not affect the existing entry for cis-1,3-dichloropropene (CAS No 10061-01-5). 

EN 

44 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
                                                 
4-Nitrobiphenyl + 

92-93-3 

202-204-7 

29042000 

i(1) 

2113-61-3 
and others 

and others 

i(2) 

i(2) 

30560-19-1 

250-241-2 

29309085 

p(1)-p(2) 

50594-66-6 

256-634-5 

29163900 

p(1)-p(2) 

15972-60-8 

240-110-8 

29242995 

p(1) 

116-06-3 

204-123-2 

29309085 

p(1)-p(2) 

834-12-8 

212-634-7 

29336980 

p(1)-p(2) 

b 

b 

b 

b-b 

b-b 

b 

sr-b 

b-b 

Acephate + 

Acifluorfen 

Alachlor + 

Aldicarb + 

Ametryn 

(cid:206)3 Amitraz +  

(cid:206)2 Anthraquinone  

Arsenic compounds 

Asbestos Fibres +: 

Crocidolite # 

Amosite # 

Antophyllite # 

(cid:206)3 33089-
61-1  

(cid:206)3 251-
375-4  

(cid:206)3 29252
900  

(cid:206)3 p(1)-
p(2)  

(cid:206)2 84-65-
1  

(cid:206)2 201-
549-0  

(cid:206)2 29146
100  

(cid:206)2 p(1)-
p(2)  

(cid:206)3 b-b  

(cid:206)2 b-b  

p(2) 

sr 

1332-21-4 
and others 

12001-28-4 

12172-73-5 

77536-67-5 

25241000 

25249000 

25249000 

i 

i 

i 

b 

b 

b 

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

EN 

45 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Actinolite # 

Tremolite # 

Chrysotile + 

(cid:206)3 Atrazine +  

Azinphos-ethyl 

Azinphos-methyl 

(cid:206)1 Benfuracarb  

Bensultap 

Benzene (1) 

Benzidine and its salts + 

Benzidine derivatives + 

77536-66-4 

77536-68-6 

12001-29-5 
or 132207-
32-0 

25249000 

25249000 

25249000 

i 

i 

i 

b 

b 

b 

(cid:206)3 1912-24-
9  

(cid:206)3 217-
617-8  

(cid:206)3 29336
910  

(cid:206)3 p(1)  

(cid:206)3 b  

2642-71-9 

220-147-6 

29339990 

p(1)-p(2) 

86-50-0 

201-676-1 

29339990 

p(1) 

b-b 

b 

(cid:206)1 82560-
54-1  

(cid:206)1 29329
900  

(cid:206)1 p(1)  

(cid:206)1 b  

17606-31-4 

29309085 

p(1)-p(2) 

71-43-2 

200-753-7 

29022000 

i(2) 

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

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

— 

— 

29215990 

i(1)-i(2) 

i(2) 

b-b 

sr 

sr-b 

b 

b-b 

b 

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

Binapacryl # 

485-31-4 

207-612-9 

29161950 

p(1)-p(2) 

i(2) 

(cid:206)2 Butralin  

(cid:206)2 33629-
47-9  

(cid:206)2 251-
607-4  

(cid:206)2 29214
900  

(cid:206)2 p(1)  

(cid:206)2 b  

EN 

46 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cadmium and its compounds 

Cadusafos + 

Calciferol 

Captafol # 

Carbaryl + 

Carbofuran + 

7440-43-9 
and others 

231-152-8 
and others 

i(1) 

8107 
32064930 
and others 

95465-99-9 

n.a. 

29309085 

p(1) 

50-14-6 

200-014-9 

29362990 

p(1) 

sr 

b 

b 

2425-06-1 

219-363-3 

29305000 

p(1)-p(2) 

b-b 

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

63-25-2 

200-555-0 

29242995 

p(1)-p(2) 

b–b 

1563-66-2 

216-353-0 

29329985 

p(1) 

Carbon tetrachloride 

56-23-5 

200-262-8 

29031400 

i(2) 

Carbosulfan + 

Cartap 

Chinomethionat 

Chlordecone 

Chlordimeform # 

Chlorfenapyr + 

Chlorfenvinphos 

Chlormephos 

55285-14-8 

259-565-9 

29329985 

p(1) 

15263-53-3 

29302000 

p(1)-p(2) 

2439-01-2 

219-455-3 

29349990 

p(1)-p(2) 

143-50-0 

205-601-3 

29147000 

p(2) 

6164-98-3 

228-200-5 

29252100 

p(1)-p(2) 

122453-73-0 

29339990 

p(1) 

470-90-6 

207-432-0 

29199090 

p(1)-p(2) 

24934-91-6 

246-538-1 

29309085 

p(1)-p(2) 

b 

b 

b 

b-b 

b-b 

sr 

b-b 

b 

b-b 

b-b 

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

EN 

47 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chlorobenzilate # 

510-15-6 

208-110-2 

29181800 

p(1)-p(2) 

b-b 

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

Chloroform 

Chlozolinate + 

Cholecalciferol 

Coumafuryl 

67-66-3 

200-663-8 

29031300 

i(2) 

84332-86-5 

282-714-4 

29349990 

p(1)-p(2) 

67-97-0 

200-673-2 

29362990 

p(1) 

117-52-2 

204-195-5 

29322985 

p(1)-p(2) 

b 

b-b 

b 

b-b 

Creosote and creosote related substances 

8001-58-9 

232-287-5 

27079100 

61789-28-4 

263-047-8 

84650-04-4 

283-484-8 

38070090 

90640-84-9 

292-605-3 

65996-91-0 

266-026-1 

i(2) 

b 

90640-80-5 

292-602-7 

65996-85-2 

266-019-3 

8021-39-4 

232-419-1 

122384-78-5 

310-191-5 

535-89-7 

208-622-6 

29335995 

p(1) 

21725-46-2 

244-544-9 

29336980 

p(1)-p(2) 

68085-85-8 

268-450-2 

29269095 

p(1) 

b 

b-b 

b 

48 

EN 

Crimidine 

Cyanazine 

Cyhalothrine 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DBB (Di-µ-oxo-di-n-butylstannio-
hydroxyborane/dioxastannaboretan-4-ol) 

75113-37-0 

401-040-5 

29310095 

i(1) 

333-41-5 

206-373-8 

29335910 

p(1) 

62-73-7 

200-547-7 

29199090 

p(1) 

(cid:206)2 115-32-
2  

(cid:206)2 204-
082-0  

(cid:206)2 29062
900  

(cid:206)2 p(1)-
p(2)  

(cid:206)2 b-b  

b 

b 

b 

Diazinon 

Dichlorvos 

(cid:206)2 Dicofol  

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

115-32-2 

204-082-0 

29062900 

p(1)-p(2) 

b-b 

Dimethenamid + 

(cid:206)2 Diniconazole-M  

87674-68-8 

n.a. 

29349990 

p(1) 

b 

(cid:206)2 83657-
18-5  

(cid:206)2 n.a.   (cid:206)2 29339

(cid:206)2 p(1)  

(cid:206)2 b  

980  

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

534-52-1 

208-601-1 

29089990 

p(1)-p(2) 

b-b 

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

2980-64-5 

221-037-0 

5787-96-2 

— 

2312-76-7 

219-007-7 

Dinobuton 

973-21-7 

213-546-1 

29209010 

p(1)-p(2) 

Dinoseb and its salts and esters # 

88-85-7 

201-861-7 

29089100 

p(1)-p(2) 

b-b 

b-b 

b 

b-b 

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

and others 

nd others 

29153600 

i(2) 

1420-07-1 

215-813-8 

29089990 

p(1)-p(2) 

(cid:206)4 ---  

(cid:206)4 ---   (cid:206)4 ---   (cid:206)4 ---  

(cid:206)4 ---  

49 

EN 

Dinoterb + 

(cid:206)4 ---  

EN 

 
  
 
 
 
 
 
 
 
 
 
 
Dustable powder formulations containing a combination 
of: 

38089990 

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

Benomyl at or above 7 % 

17804-35-2 

241-775-7 

29339990 

p(1) 

Carbofuran at or above 10 % 

1563-66-2 

216-353-0 

29329985 

p(2) 

and Thiram at or above 15 % # 

137-26-8 

205-286-2 

29303000 

Endosulfan + 

Ethion 

115-29-7 

204-079-4 

29209085 

p(1) 

563-12-2 

209-242-3 

29309085 

p(1)-p(2) 

Ethylene oxide (Oxirane) # 

75-21-8 

200-849-9 

29101000 

p(1) 

b 

b 

b 

b-b 

b 

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

(cid:206)1 Fenarimol +  

Fenitrothion 

Fenpropathrin 

Fenthion + 

Fentin acetate + 

Fentin hydroxide + 

Fenvalerate 

Ferbam 

(cid:206)1 60168-
88-9  

(cid:206)1 262-
095-7  

(cid:206)1 29335
995  

(cid:206)1 p(1)  

(cid:206)1 b  

122-14-5 

204-524-2 

29201900 

p(1) 

39515-41-8 

254-485-0 

29269095 

p(1)-p(2) 

55-38-9 

200-231-9 

29309085 

p(1) 

900-95-8 

212-984-0 

29310095 

p(1)-p(2) 

76-87-9 

200-990-6 

29310095 

p(1)-p(2) 

51630-58-1 

257-326-3 

29269095 

p(1) 

14484-64-1 

238-484-2 

29302000 

p(1)-p(2) 

b 

b-b 

sr 

b-b 

b-b 

b 

b-b 

b 

Please refer to PIC 

EN 

Fluoroacetamide # 

640-19-7 

211-363-1 

29241200 

p(1) 

EN 

50 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
circular at www.pic.int/ 

Flurenol 

(cid:206)2 Flurprimidol  

Furathiocarb 

Haloxyfop-R + 

467-69-6 

207-397-1 

29181985 

p(1)-p(2) 

b-b 

(cid:206)2 56425-
91-3  

(cid:206)2 n.a.   (cid:206)2 29335

(cid:206)2 p(1)  

(cid:206)2 b  

995  

65907-30-4 

265-974-3 

29329985 

p(1)-p(2) 

95977-29-0 

n.a. 

29333999 

p(1) 

b-b 

b 

(Haloxyfop-P-methyl ester) 

(72619-32-0) 

(406-250-
0) 

(29333999
) 

HCH/Hexachlorocyclohexane (mixed isomers) # 

608-73-1 

210-168-9 

29035100 

p(1)-p(2) 

b-sr 

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

Hexachloroethane 

67-72-1 

200-666-4 

29031980 

i(1) 

Hexazinone 

Iminoctadine 

Isoxathion 

51235-04-2 

257-074-4 

29336980 

p(1)-p(2) 

13516-27-3 

236-855-3 

29252900 

p(1)-p(2) 

18854-01-8 

242-624-8 

29349990 

p(1) 

sr 

b-b 

b-b 

b 

Lindane (γ-HCH) # 

58-89-9 

200-401-2 

29035100 

p(1)-p(2) 

b-sr 

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

Malathion 

121-75-5 

204-497-7 

29309085 

p(1) 

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

123-33-1 

204-619-9 

29339990 

p(1) 

b 

b 

(b)  Choline,  potassium  and  sodium  salts  of  maleic 
hydrazide  containing  more  than  1  mg/kg  of  free 

61167-10-0, 
51542-52-0, 

257-261-0,  29339990 

EN 

51 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
hydrazine expressed on the basis of the acid equivalent 

28330-26-9 

248-972-7 

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

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

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

28520000 

p(1)-p(2) 

b-sr 

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

(cid:206)1 Methamidophos38 +  

(cid:206)1 10265-
92-6  

(cid:206)1 233-
606-0  

(cid:206)1 29305
000  

(cid:206)1 p(1)  

(cid:206)1 b  

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

10265-92-6 

233-606-0 

29305000 

p(2) 

b 

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

Methidathion 

(cid:206)1 Methomyl  

38085000 

950-37-8 

213-449-4 

29349990 

p(1)-p(2) 

b-b 

(cid:206)1 16752-
77-5  

(cid:206)1 240-
815-0  

(cid:206)1 29309
085  

(cid:206)1 p(1)-
p(2)  

(cid:206)1 b-b  

Methyl-parathion + # 

298-00-0 

206-050-1 

29201100 

p(1)-p(2) 

b-b 

Metoxuron 

Monocrotophos # 

19937-59-8 

243-433-2 

29242190 

p(1)-p(2) 

6923-22-4 

230-042-7 

29241200 

p(1)-p(2) 

Monolinuron 

1746-81-2 

217-129-5 

29280090 

p(1) 

Monomethyl-dibromo-diphenyl methane 

99688-47-8 

402-210-1 

29036990 

i(1) 

Tradename: DBBT + 

b-b 

b-b 

b 

b 

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

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

38 

EN 

This entry does not affect the existing entry for soluble liquid formulations of methamidophos that exceed 600 g active ingredient/l. 

52 

EN 

 
  
 
 
 
 
 
 
                                                 
Monomethyl-Dichloro-Diphenyl methane; 

— 

400-140-6 

29036990 

i(1)-i(2) 

b-b 

Tradename: Ugilec 121 or Ugilec 21 + 

Monomethyl-Tetrachlorodiphenyl methane; 

76253-60-6 

278-404-3 

29036990 

i(1)-i(2) 

b-b 

Tradename: Ugilec 141 + 

Monuron 

(cid:206)2 Nicotine  

Nitrofen + 

Nonylphenols C6H4(OH)C9H19 + 

EN 

150-68-5 

205-766-1 

29242190 

p(1) 

b 

(cid:206)2 54-11-
5  

(cid:206)2 200-
193-3  

(cid:206)2 29399
900  

(cid:206)2 p(1)  

(cid:206)2 b  

b-b 

sr 

1836-75-5 

217-406-0 

29093090 

p(1)-p(2) 

246-672-0 

29071300 

i(1) 

284-325-5 

234-284-4 

291-844-0 

25154-52-3 
(phenol, 
nonyl-), 

84852-15-3 
(phenol, 4-
nonyl-, 
branched) 

11066-49-2 
(isononylphe
nol), 

90481-04-2, 
(phenol, 
nonyl-, 
branched), 

104-40-5(p-

203-199-4 

53 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Nonylphenol ethoxylates (C2H4O)nC15H24O + 

nonylphenol) 
and others 

and others 

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

34021300 

i(1) 

p(1)-p(2) 

Octabromodiphenyl ether + 

32536-52-0 

251-087-9 

29093038 

i(1) 

Omethoate 

Oxydemeton-methyl + 

(cid:206)1 Paraquat +  

Parathion # 

Pebulate 

1113-02-6 

214-197-8 

29309085 

p(1)-p(2) 

301-12-2 

206-110-7 

29309085 

p(1) 

(cid:206)1 4685-14-
7  

(cid:206)1 225-
141-7  

(cid:206)1 29333
999  

(cid:206)1 p(1)  

(cid:206)1 b  

56-38-2 

200-271-7 

29201100 

p(1)-p(2) 

b-b 

1114-71-2 

214-215-4 

29302000 

p(1)-p(2) 

Pentabromodiphenyl ether + 

32534-81-9 

251-084-2 

29093031 

i(1) 

Pentachlorophenol and its salts and esters # 

87-86-5 and 
others 

201-778-6 
and others 

29081100 

p(1)-p(2) 

29081900 
and others 

sr 

b-b 

sr 

b-b 

b 

b-b 

sr 

b-sr 

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

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

Perfluorooctane sulfonates 

1763-23-1 

n.a. 

29049020 

i(1) 

sr 

(PFOS) 

2795-39-3 

29049020 

EN 

54 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
C8F17SO2X 

and others 

and others 

(X = OH, Metal salt (O-M+), halide, amide, and other 
derivatives including polymers) + (a) 

Permethrin 

Phosalone + 

52645-53-1 

258-067-9 

29162000 

p(1) 

2310-17-0 

218-996-2 

29349990 

p(1) 

b 

b 

236-116-5 

29241200 

p(1)-p(2) 

b-b 

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

38085000 

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

Polybrominated biphenyls (PBB) # 

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 

Polychlorinated terphenyls (PCT) # 

61788-33-8 

262-968-2 

29036990 

i(1) 

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

29036990 
and others 

i(1) 

sr 

b 

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

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

(cid:206)1 Procymidone +  

(cid:206)2 Propachlor  

(cid:206)1 32809-
16-8  

(cid:206)1 251-
233-1  

(cid:206)1 29251
995  

(cid:206)1 p(1)  

(cid:206)1 b  

(cid:206)2 1918-16-
7  

(cid:206)2 217-
638-2  

(cid:206)2 29242
998  

(cid:206)2 p(1)  

(cid:206)2 b  

EN 

55 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 Propanil  

Propham 

Pyrazophos + 

Quintozene + 

Scilliroside 

(cid:206)3 Simazine +  

Strychnine 

Tecnazene + 

Terbufos 

Thallium sulphate 

Thiocyclam 

Thiodicarb + 

(cid:206)1 Tolylfluanid +  

(cid:206)2 709-98-
8  

(cid:206)2 211-
914-6  

(cid:206)2 29242
998  

(cid:206)2 p(1)  

(cid:206)2 b  

122-42-9 

204-542-0 

29242995 

p(1) 

13457-18-6 

236-656-1 

29335995 

p(1)-p(2) 

82-68-8 

201-435-0 

29049085 

p(1)-p(2) 

507-60-8 

208-077-4 

29389090 

p(1) 

b 

b-b 

b-b 

b 

(cid:206)3 122-34-
9  

(cid:206)3 204-
535-2  

(cid:206)3 29336
910  

(cid:206)3 p(1)-
p(2)  

(cid:206)3 b-b  

57-24-9 

200-319-7 

29399900 

p(1) 

117-18-0 

204-178-2 

29049085 

p(1)-p(2) 

13071-79-9 

235-963-8 

29309085 

p(1)-p(2) 

7446-18-6 

231-201-3 

28332990 

p(1) 

31895-22-4 

250-859-2 

29349990 

p(1)-p(2) 

59669-26-0 

261-848-7 

29309085 

p(1) 

(cid:206)1 731-27-
1  

(cid:206)1 211-
986-9  

(cid:206)1 29309
085  

(cid:206)1 p(1)  

(cid:206)1 b  

b 

b-b 

b-b 

sr 

sr 

b 

b-b 

b 

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

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

Tetraethyl lead # 

78-00-2 

201-075-4 

29310095 

i(1) 

Tetramethyl lead # 

75-74-1 

200-897-0 

29310095 

i(1) 

EN 

56 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Triazophos 

24017-47-8 

245-986-5 

29339990 

p(1)-p(2) 

b-b 

(cid:206)2 All tributyltin compounds, including:  

(cid:206)2 29310
095  

(cid:206)2 p(2)  

(cid:206)2 b  

(cid:206)2 Please refer to PIC 
circular at 
www.pic.int/  

(cid:206)2 Tributyltin oxide  

(cid:206)2 Tributyltin fluoride  

(cid:206)2 Tributyltin methacrylate  

(cid:206)2 Tributyltin benzoate  

(cid:206)2 Tributyltin chloride  

(cid:206)2 Tributyltin linoleate  

(cid:206)2 Tributyltin naphthenate #  

Trichlorfon + 

(cid:206)2 Tricyclazole  

(cid:206)2 56-35-
9  

(cid:206)2 200-
268-0  

(cid:206)2 29310
095  

(cid:206)2 1983-10-
4  

(cid:206)2 217-
847-9  

(cid:206)2 29310
095  

(cid:206)2 2155-70-
6  

(cid:206)2 218-
452-4  

(cid:206)2 29310
095  

(cid:206)2 4342-36-
3  

(cid:206)2 224-
399-8  

(cid:206)2 29310
095  

(cid:206)2 1461-22-
9  

(cid:206)2 215-
958-7  

(cid:206)2 29310
095  

(cid:206)2 24124-
25-2  

(cid:206)2 246-
024-7  

(cid:206)2 29310
095  

(cid:206)2 85409-
17-2  

(cid:206)2 287-
083-9  

(cid:206)2 29310
095  

52-68-6 

200-149-3 

29310095 

p(1)-p(2) 

b-b 

(cid:206)2 41814-
78-2  

(cid:206)2 255-
559-5  

(cid:206)2 29349
990  

(cid:206)2 p(1)  

(cid:206)2 b  

Tridemorph 

24602-86-6 

246-347-3 

29349990 

p(1)-p(2) 

b-b 

EN 

57 

EN 

 
  
 
 
 
 
 
 
(cid:206)1 Trifluralin  

(cid:206)3 Triorganostannic compounds other than tributyltin 
compounds +  

(cid:206)1 1582-09-
8  

(cid:206)1 216-
428-8  

(cid:206)1 29214
300  

(cid:206)1 p(1)  

(cid:206)1 b  

(cid:206)3 —  

(cid:206)3 —   (cid:206)3 29310

(cid:206)3 p(2) i(2)   (cid:206)3 sr sr  

095 

and 
others  

Tris (2,3-Dibromopropyl) phosphate # 

126-72-7 

204-799-9 

29191000 

i(1) 

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

545-55-1 

208-892-5 

29339990 

i(1) 

sr 

sr 

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

Vamidothion 

Vinclozolin 

Zineb 

2275-23-2 

218-894-8 

29309085 

p(1)-p(2) 

b-b 

50471-44-8 

256-599-6 

29349990 

p(1) 

12122-67-7 

235-180-1 

p(1) 

29302000 
or 
38249097 

b 

b 

(*) 

(**) 
(1) 

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 Union Community legislation. 

Except motor fuels subject to Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels (OJ L 
350, 28.12.1998, p.58). Directive as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1). 

CAS No = Chemical Abstracts Service Registry Number. 

# 

+ 

Chemical subject or partially subject to the PIC procedure. 

Chemical qualifying for PIC notification. 

EN 

58 

EN 

 
  
 
 
 
 
 
 
 
 
PART 2 

List of chemicals qualifying for PIC notification 

(referred to in Article 1110) 

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 NoRN 

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 

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

29214500 

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

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

202-177-1 and 
others 

29214980 

4-Nitrobiphenyl 

92-92-3 

202-204-7 

29042000 

Acephate 

Alachlor 

Aldicarb 

30560-19-1 

250-241-2 

29309085 

15972-60-8 

240-110-8 

29242995 

116-06-3 

204-123-2 

29309085 

i 

i 

i 

p 

p 

p 

b 

b 

b 

b 

b 

sr 

(cid:206)5 Amitraz  

(cid:206)5 33089-61-1  

(cid:206)5 251-375-4   (cid:206)5 29252900   (cid:206)5 p  

(cid:206)5 b  

(cid:206)6 Anthraquinone  

(cid:206)6 84-65-1  

(cid:206)6 201-549-0   (cid:206)6 29146100   (cid:206)6 p  

(cid:206)6 b  

Asbestos fibres: Chrysotile 

12001-29-5 or 132207-
32-0 

25249000 

i 

b 

(cid:206)5 Atrazine  

(cid:206)5 1912-24-9  

(cid:206)5 217-617-8   (cid:206)5 29336910   (cid:206)5 p  

(cid:206)5 b  

EN 

59 

EN 

 
  
 
(cid:206)7 Azinphos-methyl  

Benzidine and its salts 

(cid:206)7 86-50-0  

(cid:206)7 201-676-1   (cid:206)7 29339980   (cid:206)7 p  

(cid:206)7 b  

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

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

29215990 

i 

sr 

— 

— 

Benzidine derivatives 

(cid:206)6 Butralin  

(cid:206)8 ---  

Carbaryl 

(cid:206)8 ---  
(cid:206)8 ---  

Chlorfenapyr 

Chlozolinate 

(cid:206)7 Diazinon  

(cid:206)7 Dichlorvos  

(cid:206)6 Dicofol  

(cid:206)6 33629-47-9  

(cid:206)6 251-607-4   (cid:206)6 29214900   (cid:206)6 p  

(cid:206)6 b  

(cid:206)8 ---  

63-25-2 

(cid:206)8 ---  
(cid:206)8 ---  

122453-73-0 

(cid:206)8 ---  

200-555-0 

(cid:206)8 ---  
(cid:206)8 ---  

(cid:206)8 ---  

29242995 

(cid:206)8 ---  
(cid:206)8 ---  

29339990 

84332-86-5 

282-714-4 

29349990 

(cid:206)8 ---  

(cid:206)8 ---  

p 

b 

(cid:206)8 ---  
(cid:206)8 ---  

(cid:206)8 ---  
(cid:206)8 ---  

p 

p 

sr 

b 

(cid:206)7 333-41-5  

(cid:206)7 206-373-8   (cid:206)7 29335910   (cid:206)7 p  

(cid:206)7 sr  

(cid:206)7 62-73-7  

(cid:206)7 200-547-7   (cid:206)7 29199000   (cid:206)7 p  

(cid:206)7 sr  

(cid:206)6 115-32-2  

(cid:206)6 204-082-0   (cid:206)6 29062900   (cid:206)6 p  

(cid:206)6 b  

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

115-32-3 

204-082-0 

29062900 

Dimethenamid 

87674-68-8 

n.a. 

29349990 

p 

p 

b 

b 

(cid:206)6 Diniconazole-M  

(cid:206)6 83657-18-5  

(cid:206)6 n.a.  

(cid:206)6 29339980   (cid:206)6 p  

(cid:206)6 b  

EN 

60 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
Dinoterb 

Endosulfan 

(cid:206)7 Fenarimol  

(cid:206)7 Fenitrothion  

Fenthion 

Fentin acetate 

Fentin hydroxide 

(cid:206)6 Flurprimidol  

(cid:206)8 ---  
(cid:206)8 ---  
(cid:206)7 Methamidophos39  

1420-07-1 

215-813-8 

29089990 

115-29-7 

204-079-4 

29209085 

p 

p 

b 

b 

(cid:206)7 60168-88-9  

(cid:206)7 262-095-7   (cid:206)7 29335995   (cid:206)7 p  

(cid:206)7 b  

(cid:206)7 122-14-5  

(cid:206)7 204-524-2   (cid:206)7 29201900   (cid:206)7 p  

(cid:206)7 sr  

55-38-9 

900-95-8 

76-87-9 

200-231-9 

29309085 

212-984-0 

29310095 

200-990-6 

29310095 

p 

p 

p 

sr 

b 

b 

(cid:206)6 56425-91-3  

(cid:206)6 n.a.  

(cid:206)6 29335995   (cid:206)6 p  

(cid:206)6 b  

(cid:206)8 ---  
(cid:206)8 ---  

(cid:206)8 ---  
(cid:206)8 ---  

(cid:206)8 ---  
(cid:206)8 ---  

(cid:206)8 ---  

(cid:206)8 ---  

(cid:206)7 10265-92-6  

(cid:206)7 233-606-0   (cid:206)7 29305000   (cid:206)7 p  

(cid:206)7 b  

Methyl parathion # 

298-00-0 

206-050-1 

29201100 

Monomethyl-dibromo-diphenyl methane 
Tradename: DBBT 

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

Monomethyl-Tetrachlorodiphenyl methane; 
Tradename: Ugilec 141 

99688-47-8 

401-210-1 

29036990 

— 

400-140-6 

29036990 

76253-60-6 

278-404-3 

29036990 

p 

i 

i 

i 

b 

b 

b 

b 

39 

EN 

(cid:206)7 This entry does not affect the entry in Annex I Part 3 for soluble liquid formulations of methamidophos that exceed 600 g active ingredient/l.  

61 

EN 

 
  
 
 
                                                 
(cid:206)6 Nicotine  

Nitrofen 

Nonylphenols C6H4(OH)C9H19 

Nonylphenol ethoxylates (C2H4O)nC15H24O 

(cid:206)6 54-11-5  

(cid:206)6 200-193-3   (cid:206)6 29399900   (cid:206)6 p  

(cid:206)6 b  

1836-75-5 

217-406-0 

29093090 

25154-52-3 (phenol, 
nonyl-), 

246-672-0 

29071300 

84852-15-3 (phenol, 4-
nonyl-, branched), 

284-325-5 

11066-49-2 
(isononylphenol), 

234-284-4 

90481-04-2, (phenol, 
nonyl-, branched), 

291-844-0 

104-40-5 (P-
nonylphenol) and 
others 

203-199-4 and 
others 

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

34021300 

p 

i 

i 

p 

i 

p 

b 

sr 

sr 

b 

sr 

b 

Octabromodiphenyl ether 

32536-52-0 

251-087-9 

29093038 

Oxydemeton-methyl 

(cid:206)7 Paraquat  

301-12-2 

206-110-7 

29309085 

(cid:206)7 1910-42-5  

(cid:206)7 217-615-7   (cid:206)7 29333999   (cid:206)7 p  

(cid:206)7 b  

Pentabromodiphenyl ether 

32534-81-9 

251-084-2 

29093031 

Perfluorooctane sulfonates 

1763-23-1 

n.a. 

29049020 

i 

i 

sr 

sr 

EN 

62 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(PFOS) C8F17SO2X (X = OH, Metal salt (O-M+), 
halide, amide, and other derivatives including 
polymers) 

Phosalone 

(cid:206)7 Procymidone  

(cid:206)6 Propachlor  

Pyrazophos 

Quintozene 

(cid:206)5 Simazine  

Tecnazene 

Thiodicarb 

(cid:206)7 Tolylfluanid  

Trichlorfon 

(cid:206)5 Triorganostannic compounds other than 
tributyltin compounds  

2795-39-3 

and others 

2310-17-0 

29049020 

and others 

218-996-2 

29349990 

p 

b 

(cid:206)7 32809-16-8  

(cid:206)7 251-233-1   (cid:206)7 29251995   (cid:206)7 p  

(cid:206)7 b  

(cid:206)6 1918-16-7  

(cid:206)6 217-638-2   (cid:206)6 29242998   (cid:206)6 p  

(cid:206)6 b  

13457-18-6 

236-656-1 

29335995 

82-68-8 

201-435-0 

29049085 

p 

p 

b 

b 

(cid:206)5 122-34-9  

(cid:206)5 204-535-2   (cid:206)5 29336910   (cid:206)5 p  

(cid:206)5 b  

117-18-0 

204-178-2 

29049085 

59669-26-0 

261-848-7 

29309085 

p 

p 

b 

b 

(cid:206)7 731-27-1  

(cid:206)7 211-986-9   (cid:206)7 29309085   (cid:206)7 p  

(cid:206)7 sr  

52-68-6 

(cid:206)5 —  

200-149-3 

29310095 

p 

b 

(cid:206)5 —  

(cid:206)5 29310095 

(cid:206)5 p  

(cid:206)5 sr  

and others  

(cid:206)7 Vinclozolin  

(cid:206)7 50471-44-8  

(cid:206)7 256-599-6   (cid:206)7 29349990   (cid:206)7 p  

(cid:206)7 b  

(*) 

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. 

EN 

63 

EN 

 
  
 
 
 
# 

Chemical subject or partially subject to the international PIC procedure. 

PART 3 

List of chemicals subject to the PIC procedure under the Rotterdam Convention 

(referred to in Articles 1312 and 1413) 

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

Chemical 

Relevant CAS number(s) 

HS code 
Pure substance 

HS code  
Mixtures. preparations 
containing substance 

Category 

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

Aldrin (*) 

Binapacryl 

Captafol 

Chlordane (*) 

Chlordimeform 

Chlorobenzilate 

DDT (*) 

Dieldrin (*) 

93-76-5 # 

309-00-2 

485-31-4 

2425-06-1 

57-74-9 

6164-98-3 

510-15-6 

50-29-3 

60-57-1 

2918.91 

2903.52 

2916.19 

2930.50 

2903.52 

2925.21 

2918.18 

2903.62 

2910.40 

3808.50 

3808.50 

3808.50 

3808.50 

3808.50 

3808.50 

3808.50 

3808.50 

3808.50 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

EN 

64 

EN 

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

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

2908.99 

Dinoseb and its salts and esters 

1,2-dibromoethane (EDB) 

Ethylene dichloride (1,2-dichloroethane) 

Ethylene oxide 

Fluoroacetamide 

HCH (mixed isomers) 

Heptachlor (*) 

Hexachlorobenzene (*) 

Lindane 

88-85-7 # 

106-93-4 

107-06-2 

75-21-8 

640-19-7 

608-73-1 

76-44-8 

118-74-1 

58-89-9 

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

10112-91-1, 21908-53-2 and 
others  
See also: www.pic.int/ 

Monocrotophos 

Parathion 

Pentachlorophenol and its salts and esters 

6923-22-4 

56-38-2 

87-86-5 # 

2908.91 

2903.31 

2903.15 

2910.10 

2924.12 

2903.51 

2903.52 

2903.62 

2903.51 

2852.00 

2924.12 

2920.11 

2908.11 
2908.19 

3808.91 
3808.92 
3808.93 

3808.50 

3808.50 

3808.50 

3808.50 
3824.81 

3808.50 

3808.50 

3808.50 

3808.50 

3808.50 

3808.50 

3808.50 

3808.50 

3808.50 
3808.91 
3808.92 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

Pesticide 

EN 

65 

EN 

 
  
Toxaphene (*) 

8001-35-2 

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

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

— 

— 

3808.93 
3808.94 
3808.99 

3808.50 

3808.92 

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

Methyl-parathion (emulsifiable concentrates (EC) at or 
above 19,5 % active ingredient and dusts at or above 1,5 % 
active ingredient) 

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

10265-92-6 

2930.50 

3808.50 

298-00-0 

2920.11 

3808.50 

2924.12 

3808.50 

Mixture (E) & (Z) isomers 

(Z)-isomer 

(E)-isomer 

Asbestos fibres: 

13171-21-6 

23783-98-4 

297-99-4 

2524.10 
2524.90 

6811.40 
6812.80 
6812.91 
6812.92 
6812.93 
6812.99 
6813.20 

Pesticide 

Severely hazardous 
pesticide formulation 

Severely hazardous 
pesticide formulation 

Severely hazardous 
pesticide formulation 

Severely hazardous 
pesticide formulation 

Industrial 

EN 

66 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
Crocidolite 

Actinolite 

Anthophyllite 

Amosite 

Tremolite 

Polybrominated biphenyls (PBB) 

12001-28-4 

77536-66-4 

77536-67-5 

12172-73-5 

77536-68-6 

2524.10 

2524.90 

2524.90 

2524.90 

2524.90 

– 

(hexa-) 

36355-01-8 

— 

3824.82 

– 

– 

(octa-) 

(deca-) 

Polychlorinated biphenyls (PCB) (*) 

Polychlorinated terphenyls (PCT) 

Tetraethyl lead 

Tetramethyl lead 

27858-07-7 

13654-09-6 

1336-36-3 

61788-33-8 

78-00-2 

75-74-1 

— 

— 

2931.00 

2931.00 

3824.82 

3824.82 

3811.11 

3811.11 

Industrial 

Industrial 

Industrial 

Industrial 

Industrial 

(cid:206)9 All tributyltin compounds, including:  

(cid:206)9 2931.00  

(cid:206)9 3808.99  

(cid:206)9 Pesticide  

(cid:206)9 Tributyltin oxide  

(cid:206)9 Tributyltin fluoride  

(cid:206)9 56-35-9  

(cid:206)9 2931.00  

(cid:206)9 3808.99  

(cid:206)9 1983-10-4  

(cid:206)9 2931.00  

(cid:206)9 3808.99  

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(cid:206)9 Tributyltin methacrylate  

(cid:206)9 2155-70-6  

(cid:206)9 2931.00  

(cid:206)9 3808.99  

(cid:206)9 Tributyltin benzoate  

(cid:206)9 4342-36-3  

(cid:206)9 2931.00  

(cid:206)9 3808.99  

(cid:206)9 Tributyltin chloride  

(cid:206)9 Tributyltin linoleate  

(cid:206)9 1461-22-9  

(cid:206)9 2931.00  

(cid:206)9 3808.99  

(cid:206)9 24124-25-2  

(cid:206)9 2931.00  

(cid:206)9 3808.99  

(cid:206)9 Tributyltin naphthenate  

(cid:206)9 85409-17-2  

(cid:206)9 2931.00  

(cid:206)9 3808.99  

Tris (2,3-dibromopropyl) phosphate 

126-72-7 

2919.10 

3824.83 

Industrial 

(*) 

# 

These substances are subject to an export ban in accordance with the provisions of Article 1514(2) of and Annex V to this Regulation. 

Only the CAS numbers of parent compounds are listed. 

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(cid:208) 689/2008 Annex II (adapted) 

ANNEX II 

EXPORT NOTIFICATION 

⌦ The following information is ⌫ Information required pursuant to Article 87: 

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)  European  Inventory  of  Existing  Chemical  Substances  (Einecs)  number  and 

Chemical Abstracts Services (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 ⌦ mixture ⌫ preparation to be exported: 

(a) 

trade name and/or designation of the ⌦ mixture ⌫ 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. 

Identity of the article to be exported: 

(a) 

trade name and/or designation of the article; 

(b) 

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

4. 

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; 

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(e) 

(f) 

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

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. 

5. 

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. 

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

A summary on physicochemical, toxicological and ecotoxicological properties. 

Use of the chemical in the European Union: 

(a) 

uses,  category(ies)  under  the  Rotterdam  Convention  and  Union  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 IV under point 2(a), (c) and (d). 

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

6. 

7. 

8. 

9. 

10. 

11. 

12. 

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(cid:208) 689/2008 Annex III (adapted) 

ANNEX III 

Information to be supplied to the Commission by the designated national authorities of 
the Member States in accordance with Article 109 

1. 

Summary  of  quantities  of  chemicals  (in  the  form  of  substances,  ⌦ mixtures ⌫ 
preparations and articles) 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, 

⌦ mixtures ⌫ preparations and articles) as outlined below. 

Chemical 

Importing country  Quantity of substance 

2. 

List of importers 

Chemical 

Importing 
country 

Importer or 

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

importing company 

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(cid:208) 689/2008 Annex IV (adapted) 

ANNEX IV 

Notification of the Secretariat of the Convention of a banned or severely restricted 
chemical 

INFORMATION REQUIREMENTS FOR NOTIFICATIONS PURSUANT TO ARTICLE 1110 

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 ⌦ mixtures ⌫ 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 physicochemical, 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; 

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(vi)  summary  of  the  hazards  and  risks  presented  by  the  chemical  to  human 
the 

health, 
environment and the expected effect of the final regulatory action; 

the  health  of  consumers  and  workers,  or 

including 

(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 socioeconomic 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. 

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(cid:208) 689/2008 Annex V 

ANNEX V 

Chemicals and articles subject to export ban 

(referred to in Article 1514) 

PART 1 

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

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

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

Aldrin 

Chlordane 

Dieldrin 

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

Endrin 

Heptachlor 

Hexachlorobenzene 

Mirex 

EC No 206-215-8, 
CAS No 309-00-2, 
CN code 29035200 

EC No 200-349-0, 
CAS No 57-74-9, 
CN code 29035200 

EC No 200-484-5, 
CAS No 60-57-1, 
CN code 29104000 

EC No 200-024-3, 
CAS No 50-29-3, 
CN code 29036200 

EC No 200-775-7, 
CAS No 72-20-8, 
CN code 29109000 

EC No 200-962-3, 
CAS No 76-44-8, 
CN code 29035200 

EC No 200-273-9, 
CAS No 118-74-1, 
CN code 29036200 

EC No 219-196-6, 
CAS No 2385-85-5, 
CN code 29035980 

Toxaphene (camphechlor) 

EC No 232-283-3, 

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Polychlorinated biphenyls 
(PCBs) 

CAS No 8001-35-2, 
CN code 38085000 

EC No 215-648-1 and others, 
CAS No 1336-36-3 and 
others, 
CN code 29036990 

PART 2 

Chemicals  other  than  persistent  organic  pollutants  as  listed  in  Annexes A  and  B  of  the 
Stockholm Convention on Persistent Organic Pollutants according to the provisions thereof. 

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 34011100, 34011900, 34012010, 
34012090, 34013000 

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(cid:208) 689/2008 Annex VI 

ANNEX VI 

List of Parties to the Convention requiring information concerning transit movements of 
chemicals subject to the PIC procedure 

(referred to in Article 1615) 

Country 

Required information 

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APPENDIX 1 

CORRELATION TABLE 

This Regulation 

Regulation (EC) No 689/2008 

Article 1 
1.1 
1.2 
Article 2 
2.1 
2.2 
2.3 
Article 3 
Article 4 
Article 5 
5.1 
5.2 
Article 6 
6.1 
6.2 
Article 7 
7.1 
7.2 
7.3 
Article 8 
8.1 
8.2 
8.3 
8.4 
8.5 
8.6 
8.7 
8.8 
Article 9 
9.1 
9.2 
Article 10 
10.1 
10.2 
10.3 
Article 11 
11.1 
11.2 
11.3 
11.4 
11.5 
11.6 
11.7 

Article 1.1 
Article 1.2 

Article 2.1 
Article 2.2 

Article 3 
Article 4 

Article 5.2 
Article 5.3 

Article 6.1 
Article 6.2 
Article 6.3 

Article 7.1 
Article 7.2 
Article 7.3 
Article 7.4 
Article 7.5 
Article 7.6 
Article 7.7 
Article 7.8 

Article 8.1 
Article 8.2 

Article 9.1 
Article 9.2 
Article 9.3 

Article 10.1 
Article 10.2 
Article 10.3 
Article 10.4 
Article 10.5 
Article 10.6 
Article 10.7 

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11.8 
Article 12 
Article 13 
13.1 
13.2 
13.3 
13.4 
13.5 
13.6 
Article 14 
14.1 
14.2 
14.3 
14.4 
14.5 
14.6 
14.7 
14.8 
14.9 
14.10 
14.11 
Article 15 
15.1 
15.2 
Article 16 
16.1 
16.2 
16.3 
16.4 
Article 17 
17.1 
17.2 
17.3 
17.4 
Article 18 
18.1 
18.2 
18.3 
Article 19 
19.1 
19.2 
19.3 
19.4 
Article 20 
20.1 
20.2 
20.3 
Article 21 
Article 22 

Article 10.8 
Article 11 

Article 12.1 
Article 12.2 
Article 12.3 
Article 12.4 
Article 12.5 
Article 12.6 

Article 13.1 
Article 13.2 
Article 13.3 
Article 13.4 
Article 13.5 
Article 13.6 
Article 13.7 
Article 13.8 
Article 13.9 
Article 13.10 
Article 13.11 

Article 14.1 
Article 14.2 

Article 15.1 
Article 15.2 
Article 15.3 
Article 15.4 

Article 16.1 
Article 16.2 
Article 16.3 
Article 16.4 

Article 17.1 

Article 17.1 

Article 17.2 

Article 19.1 
Article 19.2 
Article 19.3 
Article 20 

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22.1 
22.2 
22.3 
Article 23 
23.1 
23.2 
23.3 
23.4 
Article 24 
24.1 
24.2 
24.3 
Article 25 
Article 26 
26.1 
26.2 
26.3 
Article 27 
27.1 
27.2 
27.3 
Article 28 
28.1 
28.2 
28.3 
Article 29 
29.1 
29.2 
Article 30 
Article 31 
Article 32 
Article 33 
Annex I 
Annex II 
Annex III 
Annex IV 
Annex V 
Annex VI 

Article 21.1 
Article 21.2 
Article 21.3 

Article 22.1 
Article 22.2 
Article 22.3 
Article 22.4 

Article 24.1 
Article 24.2 

Article 18 
Article 25 
Article 26 
Annex I 
Annex II 
Annex III 
Annex IV 
Annex V 
Annex VI 

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LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1.  Title of the proposal/initiative  

1.2.  Policy area(s) concerned in the ABM/ABB structure 

1.3.  Nature of the proposal/initiative  

1.4.  Objective(s)  

1.5.  Grounds for the proposal/initiative  

1.6.  Duration and financial impact  

1.7.  Management method(s) envisaged  

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

2.2.  Management and control system  

2.3.  Measures to prevent fraud and irregularities  

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1.  Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected  

3.2.  Estimated impact on expenditure  

3.2.1. Summary of estimated impact on expenditure  

3.2.2. Estimated impact on operational appropriations  

3.2.3. Estimated impact on appropriations of an administrative nature 

3.2.4. Compatibility with the current multiannual financial framework 

3.2.5. Third-party participation in financing  

3.3.  Estimated impact on revenue

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LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative  

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  concerning  the 
export and import of dangerous chemicals 

1.2. 

Policy area(s) concerned in the ABM/ABB structure40  

Policy area 07 Environment 

Activity Code 07 03 : Implementation of Union environmental policy and legislation 

1.3. 

Nature of the proposal/initiative  

(cid:133) The proposal/initiative relates to a new action  

(cid:133) The proposal/initiative relates to a new action following a pilot project/preparatory action41  

⌧ The proposal/initiative relates to the extension of an existing action  

(cid:133) The proposal/initiative relates to an action redirected towards a new action  

1.4. 

Objectives 

1.4.1.  The Commission's multiannual strategic objective(s) targeted by the proposal/initiative  

This proposal targets two of the Commission’s strategic objectives: 

- Managing risk in the modern world 

- Global solidarity 

by  ensuring  information  exchange  with  and  national  decision  making  of  third  countries 
concerning  the  trade  of  dangerous  substances  and  mixtures  in  line  with  the  Rotterdam 
Convention. 

1.4.2. 

Specific objective(s) and ABM/ABB activity(ies) concerned  

Specific objective No.. 

Environmental quality, chemicals & industrial emissions 

ABM/ABB activity(ies) concerned 

40 
41 

ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
As referred to in Article 49(6)(a) or (b) of the Financial Regulation. 

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Activity Code 07 03 : Implementation of Union environmental policy and legislation 

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1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

The objective of the proposal is to recast Regulation (EC) No 689/2008 to take into account: 

the  implementation  of  the  Globally  Harmonised  System  (GHS)  of  classification  and 

(1) 
labelling into Union legislation through the adoption of Regulation (EC) No 1272/2008; 

the establishment of the European Chemicals Agency ("the Agency") under Regulation 

(2) 
(EC) No 1907/2006; 

(3) 

the changes stemming from the Lisbon Treaty; 

(4) 

the experience of practical implementation achieved so far. 

The expected results/effects are therefore: 

an increase in access to and understanding of information, in particular for developing 

(1) 
countries, on the dangerous substances subject to the proposal by implementation of GHS; 

(2) 
increased  synergies  with  the  implementation  of  REACH  and  CLP  and  later  Biocides 
(see proposal for a new Regulation COM (2009) 267), by transferring administrative, technical 
and scientific work from the Commission to the Agency; 

some proposed amendments will lead to a reduction of administrative burdens regarding 

(3) 
exports that are exempted from export notification. 

The proposal will therefore continue to meet the aims of the Rotterdam Convention, namely to 
promote  shared responsibility  and  co-operative efforts among the Parties in the international 
trade  of  dangerous  chemicals  in  order  to  protect  human  health  and  the  environment  from 
potential  harm  and  to  contribute  to  their  environmentally  sound  use.  This  is  done  by 
facilitating  information  exchange  about  their  characteristics,  by  providing  for  a  national 
decision-making  process  on  their  import  and  export  and  by  disseminating  these  decisions  to 
Parties 

1.4.4. 

Indicators of results and impact  

Specify the indicators for monitoring implementation of the proposal/initiative. 

The proposed regulation, as is the case of the current regulation, aims at providing information 
to third countries and taking into account their decision on the import of substances exported 
from the EU although banned or severely restricted domestically. Indicators for monitoring the 
implementation of the proposal are therefore: 

- the number of export notifications dispatched and import notifications received; 

- the number of explicit consents requested; 

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- the number of problems encountered in the implementation of the proposed regulation and 
reported to the network of designated national authorities coordinated by the Commission; 

-  the  number  of  violations  of  the  provisions  of  the  proposed  regulation  as  identified  by  the 
national enforcement authorities 

These  indicators  will  be  summarised  in  the  reporting  carried  out  by  the  Member  states,  the 
Agency and the Commission. 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term  

The  main  requirement  to  be  met  is  to  align  Regulation  (EC)  No  689/2008,  which  refers  to 
specific  classification  and  labelling  provisions  of  Directive  67/548/EEC  and  Directive 
1999/45/EC with the new provisions for classification and labelling set out in Regulation (EC) 
No  1272/2008,  implementing  the  Globally  Harmonised  System  (GHS)  of  classification  and 
labelling  into  Union  legislation,  enabling  operators  to  apply  one  consistent  system  of 
classification and labelling. 

In  addition  the  transfer  of  tasks  from  the  Commission  to  the  Agency  ensures  a  more 
appropriate setting for carrying out the administrative, scientific and technical support to the 
implementation 

1.5.2.  Added value of EU involvement 

The  proposed  regulation  does  not  alter  any  of  the  objectives  set  in  Regulation  (EC)  No 
689/2008  and  hence  the  added  value  of  EU  involvement  is  identical  to  that  of  the  current 
regulation. 

Regulation  (EC)  No  689/2008  implements  the  Union’s  responsibilities  as  agreed  in  the 
Rotterdam Convention. A was seen at the time of adoption of Regulation (EC) No 689/2008 
an EU regulation was the most efficient means of meeting those obligations 

1.5.3.  Lessons learned from similar experiences in the past 

The experience gained from the implementation of Regulation (EC) No 689/2008 shows that it 
is  appropriate  to  include  certain  technical  amendments  to  the  operative  provisions  such  as 
clarify the definitions of a substance, a mixture and an article, and the reference identification 
number required for exports that are not subject to export notification. 

The  scientific  and  technical  work  related  to  the  implementation  of  Regulation  (EC)  No 
689/2008  is  being  performed  by  the  Commission’s  Joint  Research  Centre,  due  to  its  unique 
mandate  within  the  Commission  of  providing  scientific  and  technical  support  for  the 
conception, development, implementation and monitoring of EU policies. Other scientific and 
technical  work  was  also  performed  by  the  JRC  in  the  past  concerning  industrial  chemicals 
(Directive  No  67/548/EEC,  Regulation  (EEC)  No  793/93,  Directive  No  98/8/EC  and 
Regulation No (EC) 1907/2006), but this has been or is in the process of being transferred to 
the Agency in Helsinki. 

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The creation of the Agency and the transfer of tasks from the JRC to the Agency were based 
on  an  extensive  feasibility  study,  which  concluded  that  an  independent  Agency  was  in  the 
longer  term  the  preferred  structure  to  carry  out  the  scientific  and  technical  tasks  needed  for 
implementing the chemicals legislation in comparison to maintaining the work within the JRC. 
The  feasibility  study  concluded  that  the  decision  could  not  be  made  due  to  any  underlying 
differences in costs, but could be made based on structural differences: 

-  An  independent  Agency  is  better  placed  to  receive  and  use  fee  income  for  performing 
specific tasks; 

- An independent Agency is better placed to ensure long term stability in the number of staff 
allocated to specific tasks; 

- An  independent Agency can  better ensure long term planning and resource availability for 
routine scientific tasks which need to be performed over a longer period of time. 

The  JRC  was  then  seen  to  have  the  advantage  that  synergies  could  be  achieved  with  other 
work  being  done  on  chemical  legislation  implementation,  leading  the  feasibility  study  to 
conclude that an independent Agency located at the relevant site of the JRC would be the ideal 
solution. 

The  analysis  and  conclusions  made  in  establishing  the  Agency  for  certain  chemicals  policy 
areas  is  equally  valid  and  relevant  for  Regulation  (EC)  No  689/2008,  with  two  important 
differences: 

(1) the current recast of Regulation (EC) No 689/2008 does not foresee fees to be collected, 
albeit it will consider the feasibility at a later stage; 

(2) not the JRC but the Agency now houses the competences for implementing certain other 
chemical policies. 

It  can  therefore  be  concluded  that  the  scientific  and  technical  work  necessary  for 
implementing Regulation (EC) No 689/2008 can best be done by an independent Agency, in 
particular  if  at  a  later  stage  fees  will  be  collected  and  that  the  best  location  of  that  Agency 
would be in Helsinki, to utilise the synergies which can be obtained from the Agency's other 
chemicals  work.  Clearly  adding  the  tasks  to  an  existing  Agency  will  be  more  efficient  than 
creating  a  new  Agency,  as  the  functioning  administrative  infrastructure  can  be  used  and 
synergies in terms of staff and infrastructure can be expected. 

1.5.4.  Coherence and possible synergy with other relevant instruments 

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. 

By  placing  the  scientific  and  technical  work  related  to  the  implementation  of  the  proposed 
regulation at the Agency, synergies are expected with the implementation work carried out by 
the Agency on REACH, CLP and also in the future Biocides (proposal for a new Regulation 
COM (2009) 267). 

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1.6. 

Duration and financial impact  

(cid:133) Proposal/initiative of limited duration  

–  (cid:133) Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–  (cid:133) Financial impact from YYYY to YYYY  

⌧ Proposal/initiative of unlimited duration 

–  Implementation with a start-up period from 2012 to 2013, 

–  followed by full-scale operation from 01.04.2013 (estimated). 

1.7.  Management mode(s) envisaged42  

⌧Centralised direct management by the Commission  

⌧Centralised indirect management with the delegation of implementation tasks to: 

–  (cid:133) executive agencies  

–  ⌧ bodies set up by the Communities43  

–  (cid:133) national public-sector bodies/bodies with public-service mission  

–  (cid:133) persons entrusted with the implementation of specific actions pursuant to Title V of the 
Treaty  on  European  Union  and  identified  in  the  relevant  basic  act  within  the  meaning  of 
Article 49 of the Financial Regulation  

(cid:133) Shared management with the Member States  

(cid:133) Decentralised management with third countries  

(cid:133) Joint management with international organisations (to be specified) 

If more than one management mode is indicated, please provide details in the "Comments" section. 

Comments  

42 

43 

Details  of  management  modes  and  references  to  the  Financial  Regulation  may  be  found  on  the  BudgWeb  site: 
http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html 
As referred to in Article 185 of the Financial Regulation. 

EN 

86 

   EN 

 
 
 
                                                 
2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

(1)  Member  States  and  the  Agency  will  regularly  forward  to  the  Commission  information 
concerning  the  operation  of  the  Regulation,  including  customs  controls,  infringements, 
penalties and remedial action. 

(2)  The  Commission  in  turn  will  regularly  compile  a  report  on  the  operation  of  the 
Regulation  for  which  it  is  responsible  and  shall  incorporate  it  into  a  synthesis  report 
integrating the information provided by the Member States and the Agency. Furthermore, the 
Commission  will  prepare  a  summary  of  the  report  for  the  purpose  of  publication  on  the 
Internet and forward it to the European Parliament and to the Council. 

(3)  The Member States, the Agency and the Commission will protect where necessary the 
confidentiality of data and its ownership. 

2.2.  Management and control system  

2.2.1.  Risk(s) identified  

The main risks are: 

- failure of exporters to comply with their obligations; 

- non uniform implementation of the proposal in Member States; 

- insufficient control systems, e.g. customs controls, in Member States; 

- failure of the Agency to carry out it's tasks. 

2.2.2.  Control method(s) envisaged  

Multiple  management  and  control  systems  are  in  place  or  will  be  put  in  place  to  ensure  the 
appropriate implementation of the proposed regulation: 

- Member States are requested to designate authorities responsible for controlling exports and 
imports; 

- The technical and scientific coordination of the EU's work is monitored through the meeting 
of the designated national authorities, chaired by the Commission; 

-  The  day-to-day  management  of  the  Agency's  tasks  fall  under  the  responsibility  of  the 
Executive Director, who in turn reports to the Agency's Management Board. 

In  addition  this  financial  fiche  gives  the  basis  for  the  subsidy  necessary  for  the  Agency  to 
carry out it’s tasks. 

EN 

87 

   EN 

 
2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures. 

The standard measures in place to prevent fraud and irregularities in the Commission apply for 
the tasks carried out by the Commission under this proposal. 

In order to combat fraud, corruption and other unlawful activities, the provisions of Regulation 
(EC) No 1037/1999 apply without restrictions to this Agency. 

The  Agency  has  acceded  to  the  Inter-institutional  Agreement  of  May  25,  1999  concerning 
internal investigations by Olaf and has issued the appropriate provisions applicable to its entire 
staff. 

The decisions concerning funding and the implementing agreements and instruments resulting 
from them stipulate that the Court of Auditors and Olaf may carry out, if necessary, on-the-
spot checks of the recipients of the Agency's funding and the agents responsible for allocating 
it. 

EN 

88 

   EN 

 
3. 

3.1. 

Heading of 
multiannual 
financial 
framework 

Heading of 
multiannual 
financial 
framework 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected  

•  Existing expenditure budget lines  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of  
expenditure

Contribution  

Number  
[Description………………………...……….] 

DA/NDA 
(44) 

from 
EFTA45 
countries 

from 
candidate 
countries46 

from third 
countries 

within the meaning 
of Article 18(1)(aa) 
of the Financial 
Regulation  

[XX.YY.YY.YY] 

DA/ND
A 

YES/N
O 

YES/N
O 

YES/N
O 

YES/NO 

•  New budget lines requested  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of 
expenditure

Contribution  

Number  
[Heading……………………………………..] 

Diff./non-
diff. 

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

within the meaning 
of Article 18(1)(aa) 
of the Financial 
Regulation  

07. 03 70 01 

2 

2 

Chemicals  Agency  –  Activities  in  the 
Field of  Legislation on PIC  – subsidy 
under Titles 1&2 

07. 03 70 02 

Chemicals  Agency  –  Activities  in  the 
Field  of  Legislation  on  PIC–  subsidy 
under Title 3 

Diff 

YES 

NO 

NO 

NO 

Diff 

YES 

NO 

NO 

NO 

44 
45 
46 

DA= Differentiated appropriations / NDA= Non-Differentiated Appropriations 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidate countries from the Western Balkans. 

EN 

89 

   EN 

 
 
 
                                                 
3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial 
framework:  

Number  2. Preservation and Management of Natural Resources 

EUR million (to 3 decimal places) 

DG: Environment 

2012 

2013 

2014 

2015 

201647 

TOTAL 

(cid:121) Operational appropriations  

07.03.70.01 

07.03.70.02 

Appropriations 
of 
 from the envelop of specific programs48  
Number of budget line 

an 

administrative 

TOTAL appropriations 
for DG Environment 

Commitments 

Payments 

Commitments 

Payments 

(1) 

(2) 

(1a) 

(2a) 

nature 

financed 

Commitments 

Payments 

(3) 

=1+1a 
+3 

=2+2a 

+3 

0,349 
0,349 
1,122 
1,122 

0,620 
0,620 
1,012 
1,012 

0,718 
0,718 
0,563 
0,563 

0,744 
0,744 
0,463 
0,463 

0,772 
0,772 
0,363 
0,363 

1,470 

1,632 

1,281 

1,207 

1,135 

1,470 

1,632 

1,281 

1,207 

1,135 

47 
48 

EN 

The yearly budget remains unchanged from 2018 onwards 
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former "BA" lines), indirect research, direct 
research. 

90 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelop of specific programs  

(4) 

(5) 

(6) 

1,470 

1,470 

1,632 

1,632 

1,281 

1,281 

1,207 

1,207 

1,135 

1,135 

TOTAL appropriations  
under HEADING 2 
of the multiannual financial framework 

Commitments 

=4+ 6 

1,470 

1,632 

1,281 

1,207 

1,135 

Payments 

=5+ 6 

1,470 

1,632 

1,281 

1,207 

1,135 

If more than one heading is affected by the proposal / initiative: 

(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelop of specific programs  

(4) 

(5) 

(6) 

TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial framework 
(Reference amount) 

Commitments 

=4+ 6 

Payments 

=5+ 6 

EN 

91 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial 
framework:  

5 

" Administrative expenditure " 

EUR million (to 3 decimal places) 

DG: Environment 

(cid:121) Human resources  
(cid:121) Other administrative expenditure  

2012 

2013 

2014 

2015 

TOTAL 

0,191 

0,025 

0,191 

0,025 

0,191 

0,025 

0,191 

0,025 

TOTAL DG Environment 

Appropriations  

0,216 

0,216 

0,216 

0,216 

DG: JRC 

(cid:121) Human resources  
(cid:121) Other administrative expenditure  

0,058 

0,088 

0,039 

0,059 

TOTAL DG JRC 

Appropriations  

0,146 

0,098 

TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework  

(Total 
= Total payments) 

commitments 

0,362 

0,314 

0,216 

0,216 

TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework  

Commitments 

1,832 

1,946 

1,497 

1,423 

Payments 

1,832 

1,946 

1,497 

1,423 

EUR million (to 3 decimal places) 

TOTAL 

EN 

92 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on operational appropriations  

–  (cid:133) The proposal/initiative does not require the use of operational appropriations  

–  ⌧ The proposal/initiative requires the use of operational appropriations, as explained below: 

Year 
2012 

Year 
2013 

Year 
2014 

Year 
2015 

… enter as many years as necessary to show 
the duration of the impact (see point 1.6) 

TOTAL 

Commitment appropriations in EUR million (to 3 decimal places) 

OUTPUTS 

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

Total 
numbe
r of 
output
s 

Total  
cost 

Indicate 
objectives and 
outputs  

(cid:216) 

Type 
of 
output
49 

Avera
ge 
cost  
of the 
output 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

SPECIFIC OBJECTIVE No 150… 

- IT system 

- Export 
notifications 

- DGDs + PIC 
notifications 

1 

1,000 

1 

0,800 

1 

0,350 

1 

0,250 

0,406 

200
0 

0,768 

5300 

0,867 

5800 

0,893 

0,064 

2 

0,064 

7 

0,064 

7 

0,064 

Sub-total for specific objective N°1 

1,470 

1,632 

1,281 

1,207 

SPECIFIC OBJECTIVE No 2… 

- Output 

Sub-total for specific objective N°2 

49 
50 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 
As described in Section 1.4.2. "Specific objective(s)…" 

EN 

93 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
TOTAL COST 

1,470 

1,632 

1,281 

1,207 

Current costs for the administrative, scientific and technical work that are covered by the operational budget 2010 -2011 (070307) amount to 444.000€ 
in 2010 and 400.000€ in 2011, and cover an Administrative Arrangement with the JRC and a service contract. The transfer to the Agency is expected 
to create high costs in 2012 and 2013 for development of new software, which would also be necessary for either alternative approach due to the age 
of the current database. After this initial phase, operating costs are expected to only slightly increase proportionally to the increase of the workload. An 
investment and transition phase is necessary in 2012-2013 in particular for IT investments by the Agency. Once the Agency activities have started in 
2013,  the  overall  expenditure  of  the  Agency  will  be  stable,  while  an  increase  in  export  notifications  and  requests  for  explicit  consent  processed  is 
expected – the "unit cost' per output will therefore decrease from 163€ in 2014 to 106€ in 2020. 

EN 

94 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.3.1.  Summary  

–  (cid:133) The  proposal/initiative  does  not 

require 

the  use  of  administrative 

appropriations  

–  ⌧ The  proposal/initiative  requires  the  use  of  administrative  appropriations,  as 

explained below: 

EUR million (to 3 decimal places) 

Year 
2012 51 

Year 
2013 

Year 
2014 

Year 
2015 

… enter as many years as necessary 
to show the duration of the impact 
(see point 1.6) 

TOTAL 

DG ENV HEADING 5 
of the multiannual 
financial framework 

Human resources  

0,191 

0,191 

0,191 

0,191 

0,025 

0,025 

0,025 

0,025 

0,216 

0,216 

0,216 

0,216 

Other administrative 
expenditure  

Subtotal DG ENV 
HEADING 5 
of the multiannual 
financial framework  

DG JRC 
HEADING 552 
of the multiannual 
financial framework  

Human resources  

0,058 

0,039 

Other expenditure  
of an administrative 
nature 

Subtotal DG JRC 
HEADING 5 
of the multiannual 
financial framework  

0,088 

0,059 

0,146 

0,098 

TOTAL 

0,362 

0,314 

0,216 

0,216 

51 
52 

Year N is the year in which implementation of the proposal/initiative starts. 
Technical  and/or  administrative  assistance  and  expenditure  in  support  of  the  implementation  of  EU 
programmes and/or actions (former "BA" lines), indirect research, direct research. 

EN 

95 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
The  level  of  administrative  expenditure  in  DG  ENV  will  remain  the  same  under  the  recast  Regulation.  JRC 
administrative expenditure (estimated at EUR 146.000 in 2011 will have to be maintained in 2012 and partly in 
2013 in order to ensure continuity of operations until the Agency takes over operation of the system. 

EN 

96 

   EN 

 
3.2.3.2.   Estimated requirements of human resources  

–  (cid:133) The proposal/initiative does not require the use of human resources  

–  ⌧ The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

Estimate to be expressed in full amounts (or at most to one decimal place) 

Year 
2012 

Year 
2013 

Year 
2014 

Year 
2015 

… enter as many years as 
necessary to show the 
duration of the impact 
(see point 1.6) 

(cid:121) Establishment plan posts (officials and temporary agents) 

XX 01 01 01 (Headquarters and Commission’s 
Representation Offices) 

1,5 

1,5 

1,5 

1,5 

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

(cid:121) External personnel (in Full Time Equivalent unit: FTE)53 

XX 01 02 01 (CA, INT, SNE from the "global 
envelope") 

XX 01 02 02 (CA, INT, JED, LA and SNE in 
the delegations) 

XX 01 04 yy 54 

- at Headquarters55 

- in delegations  

XX 01 05 02 (CA, INT, SNE - Indirect 
research) 

10 01 05 02 (CA, INT, SNE - Direct research) 

Other budget lines (specify) 

TOTAL 

XX is the policy area or budget title concerned. 

The human resources required will be met by staff from the DG who are already assigned to 
management of the action and/or have been redeployed within the DG, together if necessary 
with  any  additional  allocation  which  may  be  granted  to  the  managing  DG  under  the  annual 
allocation procedure and in the light of budgetary constraints. 

The current distribution of tasks in the Commission is as follows:  

-  DG  ENV  runs  the  policy  development  and  is  responsible  for  implementation  of  the  PIC 
Regulation  in  the  EU,  including  the  adoption  of  legislation,  and  for  all  international 

53 

54 
55 

CA= Contract Agent; INT= agency staff ("Intérimaire"); JED= "Jeune Expert en Délégation" (Young 
Experts in Delegations); LA= Local Agent; SNE= Seconded National Expert;  
Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
Essentially  for  Structural  Funds,  European  Agricultural  Fund  for  Rural  Development  (EAFRD)  and 
European Fisheries Fund (EFF). 

EN 

97 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
obligations  stemming  from  the  Convention.  DG  ENV  represents  the  European  Union  at 
Convention  level,  including  the  Chemical  Review  Committee,  and  does  the  international 
negotiations work.  

- The JRC (Ispra) carries out the administrative and technical work relating to the EDEXIM 
database. 

Since  DG  ENV  will  keep  the  complete  work  package,  there  are  no  changes  as  regards 
resources  required.  However,  there  will  be  savings  in  JRC  from  2013  onwards  due  to  the 
transfer of the work to the Agency. 

Description of tasks to be carried out: 

Officials and temporary agents 

External personnel 

DG  ENV  is  responsible  for  policy  development  and  implementation  of  the  PIC 
Regulation  in  the  EU,  including  the  adoption  of  legislation,  and  for  all  international 
obligations stemming from the Convention. DG ENV represents the European Union 
at  Convention  level,  including  the  Chemical  Review  Committee,  and  does  the 
international negotiations work. 

EN 

98 

   EN 

 
 
3.2.4.  Compatibility with the current multiannual financial framework  

–  ⌧ Proposal/initiative is compatible with the current multiannual financial framework. 

–  (cid:133) Proposal/initiative will entail reprogramming of the relevant heading in the multiannual financial framework. 

Explain what reprogramming is required, specifying the budget lines concerned and the corresponding amounts. 

–  (cid:133) Proposal/initiative requires application of the flexibility instrument or revision of the multiannual financial framework56. 

Explain what is required, specifying the headings and budget lines concerned and the corresponding amounts. 

3.2.5.  Third-party contributions  

–  The proposal/initiative does not provide for co-financing by third parties  

The regulation contains a review clause where after no longer than 5 years of operation the Commission will review the possibility of 
introducing fees to finance the works carried out by the Agency, in contrast to doing so through the subsidy. This review will take into 
account the impact such fees will have on the economic operators involved. If the Commission decides to introduce fees, then this will 
be done through an amendment to the current proposal which would require adoption through the ordinary legislative procedure. 

Appropriations in EUR million (to 3 decimal places) 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

… enter as many years as 
necessary to show the duration 
of the impact (see point 1.6) 

Total 

56 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

99 

 
  
 
 
 
 
 
                                                 
Specify  the  co-financing 
body  

TOTAL appropriations 
cofinanced  

EN 

100 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.3. 

Estimated impact on revenue  

–  ⌧ Proposal/initiative has no financial impact on revenue. 

–  (cid:133) Proposal/initiative has the following financial impact: 

– 

– 

(cid:133) 

(cid:133) 

on own resources  

on miscellaneous revenue  

Appropriation
s available for 
the ongoing 
budget 
exercise 

Budget revenue line: 

Article …………. 

Impact of the proposal/initiative57 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

… insert as many columns as necessary 
in order to reflect the duration of the 
impact (see point 1.6) 

For miscellaneous assigned revenue, specify the budget expenditure line(s) affected. 

Specify the method for calculating the impact on revenue. 

EUR million (to 3 decimal places) 

57 

EN 

As  regards  traditional  own  resources  (customs  duties,  sugar  levies),  the  amounts  indicated  must  be  net  amounts,  i.e.  gross  amounts  after  deduction  of  25%  for 
collection costs. 

101 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
ANNEX 1 

Draft Budget for the European Chemicals Agency (in Euros) 

Tasks related to Prior Informed Consent 

2012 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

251.100 
33.600 
284.700 

471.800 
45.600 
517.400 

505.900 
67.800 
573.700 

523.800 
70.200 
594.000 

543.800 
72.900 
616.700 

563.900 
75.600 
639.500 

570.600 
76.500 
647.100 

570.600 
76.500 
647.100 

570.600 
76.500 
647.100 

570.600 
76.500 
647.100 

33.000 
21.100 
5.100 
4.700 
100 
64.000 

50.000 
33.700 
8.800 
9.900 
200 
102.600 

74.900 
49.700 
10.400 
9.500 
200 
144.700 

77.600 
51.400 
10.700 
9.800 
200 
149.700 

80.500 
53.400 
11.100 
10.200 
200 
155.400 

83.500 
55.400 
11.600 
10.500 
200 
161.200 

84.500 
56.000 
11.700 
10.700 
200 
163.100 

84.500 
56.000 
11.700 
10.700 
200 
163.100 

84.500 
56.000 
11.700 
10.700 
200 
163.100 

84.500 
56.000 
11.700 
10.700 
200 
163.100 

1.000.000 
10.000 
0 
100.000 
5.000 
900 

800.000 
10.000 
20.000 
100.000 
10.000 
2.000 

350.000 
10.000 
20.000 
100.000 
10.000 
2.700 

250.000 
10.000 
20.000 
100.000 
10.000 
2.700 

150.000 
10.000 
20.000 
100.000 
10.000 
2.800 

150.000 
10.000 
20.000 
100.000 
10.000 
3.000 

100.000 
10.000 
20.000 
100.000 
10.000 
3.000 

100.000 
10.000 
20.000 
100.000 
10.000 
3.000 

100.000 
10.000 
20.000 
100.000 
10.000 
3.000 

100.000 
10.000 
20.000 
100.000 
10.000 
3.000 

5.700 
1.121.600 

70.000 
1012.000 

70.200 
562.900 

70.200 
462.900 

70.200 
363.000 

70.200 
363.200 

70.200 
313.200 

70.200 
313.200 

70.200 
313.200 

70.200 
313.200 

Expenditure 
Title1 
Salaries & allocations 
Other personnel costs 
Total Title 1 

Title 2 

20 Rental of building and associated costs* 
21 Information & communication technology** 
22 Movable property and associated costs** 
23 Current administrative expenditure* 
25 Meetings expenditure* 

Total Title 2 

Title 3 

Development  of  databases  and  software  tools  related 
to the operation of PIC 
Information and publications 
Helpdesk services/Guidance 
Studies and Consultants 
Mission expenses 
Technical training of staff and stakeholders 

Meetings  of  the  DNAs  and  expert  groups  on  PIC 
implementation 
Total Title 3 

Total 
Revenues 
Union subvention 

Total 

1.470.300 

1.632.000 

1.281.300 

1.206.600 

1.135.100 

1.163.900 

1.123.400 

1.123.400 

1.123.400 

1.123.400 

1.470.300 

1.632.000 

1.281.300 

1.206.600 

1.135.100 

1.163.900 

1.123.400 

1.123.400 

1.123.400 

1.123.400 

1.470.300 

1.632.000 

1.281.300 

1.206.600 

1.135.100 

1.163.900 

1.123.400 

1.123.400 

1.123.400 

1.123.400 

EN 

102 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
 
 
ANNEX II 
Applied methodology and main underlying assumptions for the financial model of the 
European Chemicals Agency for activities relating to PIC 

Computation of staff costs 

Due to the fact that the European Chemicals Bureau (ECB) of the Commission JRC in Ispra 
currently has a major role in implementing Regulation (EC) 689/2008, significant experience 
exists with regard to how long certain tasks take and what kind of qualifications are needed in 
order to carry them out (differentiation between different categories of staff). 

To  this  staff  additional  resource  requirements  have  been  added  for  the  management  and 
training  of  these  resources,  taking  into  account  economies  of  scale  that  can  be  achieved  in 
particular in support tasks and staff from existing arrangements set up for the implementation 
of  the  REACH,  CLP  and  Biocides  Regulations  (e.g.  for  international  relations,  for  external 
communication, helpdesk services, the Legal Department, Audit and Internal Control, Human 
Resources (HR), Finance, Information Technology (IT) and Building Management). Based on 
the  current  staff  ratio  of  the  Agency,  these  additional  resources  amount  to  30%  of  those 
required for the operational tasks related to the PIC regulation. 

From January 2012, it is proposed that the Agency should be able to start work, primarily on 
developing the IT system, setting up internal procedures, and set off the recruit procedures for 
staff for 2012. 

For 2012, it is proposed that the Agency should be able to recruit most of the required staff 
and ensure from the Agency's side a smooth hand-over of the PIC tasks from the Commission. 

From 1 April 2013, the Agency would then be responsible for the different tasks set out in the 
proposal. 

Annex III sets out the proposed establishment plan related to this proposal. The budget set out 
in Annex  I takes  into  account  permanent / temporary staff  (i.e.  that  appear in establishment 
plan). 

All the resources computed have been multiplied by the average annual cost by grade and that 
has led to the total staff costs. In addition, the weighting factor for Helsinki (119.8% – cost of 
living adjustment applicable to all staff) has been applied. 

The other personnel costs in  Title 1 have been assumed to represent 10% of salary costs of 
permanent / temporary staff. 

Applied average costs for permanent/temporary staff by grade per annum (source the Agency) 

Grade 

AD 13 
AD 12 
AD 5-11 
AST 7-8 
AST 1-6 

Salary 
243,156 
195,900 
120,288 
104,778 
66,872 

EN 

103 

   EN 

 
 
 
 
 
Applied average costs for contract agents by function group per annum (source the Agency) 

Grade 

Salary 

FG IV 
FG III 
FG II 
FG I 

55,869 
55,287 
37,319 
34,813 

Computation of building, equipment and miscellaneous operating expenditure: 

All  building,  equipment,  furniture,  IT  and  other  administrative  expenditure  have  been 
computed based on the number of required staff multiplied by average cost figures per person 
based on the current Agency budget. 

Operating expenditure: 

The major cost driver for the first years is the development of an IT system to support the PIC 
implementation.  In  addition  it  is  foreseen  that  the  Agency  hosts  one technical  meeting  with 
Member States per year, has an expert support groups for the IT development and maintain 
and can give training to Member State staff. 

There  is  also  a  continuous  expense  for  consultancies  to  support  in  particular  the  Agency's 
annual and regular reporting. 

Finally, the mission expenses are higher than average per staff compared to the current tasks 
of the Agency due to the international character of the work and the need for the Commission 
to have scientific and technical support on site at international meetings. 

EN 

104 

   EN 

 
 
 
 
 
ANNEX III 
European Chemicals Agency 
ESTABLISHMENT PLAN 
Additional staff to carry out activities related to PIC 

2012 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

AD 13 

AD 12 

AD 5-11 

AST 7-11 

AST 1-6 

0 

0 

1 

1 

1 

0 

0 

1 

3 

1 

0 

0 

1 

2 

0 

0 

1 

2 

0 

0 

1 

2 

0 

0 

1 

2 

0 

0 

1 

2 

0 

0 

1 

2 

0 

0 

1 

2 

0 

0 

1 

2 

2,7 

3,0 

3,3 

3,6 

3,6 

3,6 

3,6 

3,6 

Overall 

3 

5 

6 

6 

6 

7 

7 

7 

7 

7 

EN 

105 

   EN