CELEX: 52011PC0245
Language: en
Date: 2011-05-05
Title: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the export and import of dangerous chemicals(recast)

|
			
		
		
		52011PC0245
		
			Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the export and import of dangerous chemicals(recast) /* COM/2011/0245 final - COD 2011/0105 */
			
				
		
		
			
			   	EN
 || 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)
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 chemicals[1]
('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:
–                        
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dangerous preparations, which are or will be replaced and repealed by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) 1907/2006[2].
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 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 196/2010[3].
The Regulation goes significantly beyond
the requirements of the Convention. The key differences can be summarised as
follows:
1.                      
The rules apply to exports to all countries,
whether or not they are Parties to the Convention; 
2.                      
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;
4.                      
Certain articles and chemicals (such as those
chemicals that are also subject to the Stockholm Convention on Persistent
Organic Pollutants) are banned for export;
5.                      
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; 
–                        
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 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. 

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.
ê 689/2008
(adapted)
ð 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
ð (Text with EEA relevance) ï
THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty Ö on the
Functioning of the European Union Õestablishing the European
Community, and in particular Ö Article 192(1)
and Article 207 ÕArticles 133 and 175(1)
thereof,
Having regard to the proposal from the Ö European Õ Commission,
Ö After
transmission of the draft legislative act to the national Parliaments, Õ 
Having regard to the Opinion of the
European Economic and Social Committee[5],
Ö Having
regard to the opinion of ÕAfter consulting
the Committee of the Regions,
Acting in accordance with the Ö ordinary
legislative Õ procedure laid down in Article 251
of the Treaty[6],
Whereas:
ò new
(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 chemicals[7]. In the interest of clarity, Regulation
(EC) No 689/2008 should be recast.
ê 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 chemicals[8]
implementsed
the Rotterdam Convention on the prior informed consent procedure for certain
hazardous chemicals and pesticides in international trade[9], 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 chemicals[10]
replaced
Council Regulation (EEC) No 2455/92 of 23 July 1992 concerning the
export and import of certain dangerous chemicals[11].
ê 689/2008
recital (2)
(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.
ò new
(3)       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/EC[13],
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) 1907/2006[14] on the other hand.
ê 689/2008
recital (3)
(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.
ê 689/2008
recital (4) (adapted)
ð new
(4)       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 ð ensure a higher ï weaken the level of
protection Ö of Õ 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.
ê 689/2008
recital (5)
(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.
ò new
(6)       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 to the administrative, technical and
scientific aspects of 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.
ê 689/2008
recital (12) (adapted)
ð new
(7)       ð Given that certain tasks of the
Commission should be transferred to the Agency, the European Database on Export
and Import of Dangerous Chemicals initially ï The
database established by the Commission ð should be further developed and
maintained by the Agency. ï, is an important tool which should underpin the application of this Regulation and
its control.
ê 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 Ö mixtures Õ 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.
ê 689/2008
recital (7)
(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. 
ê 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.
ê 689/2008
recital (9)
(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.
ê 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.
ê 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.
ê 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.
ê 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.
ê 689/2008
recital (15)
(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.
ê 689/2008
recital (16)
ð new
(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 those
countries, taking into account relevant international standards. ð 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. ï
ê 689/2008
recital (17) (adapted)
ð 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)     Ö In order Õ 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. ð 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. ï 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.
ê 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.
ê 689/2008
recital (19)
ð new
(2119) There
should be regular monitoring of the operation of the procedures if they are to
be effective. To this end, Member States ð and the Agency ï should regularly submit reports to the Commission, which should in
turn regularly report to the European Parliament and the Council.
ê 689/2008
recital (20)
ð new
(2220) Technical
notes for guidance should be drawn up ð by the Agency ï to assist the competent authorities, including such authorities as
customs controlling exports, ð exporters and importers ï in the application of this Regulation.
ê 689/2008
recital (22) (adapted)
ð new
(2322) In particular t
The Commission should be empowered to adopt ð delegated acts in accordance with
Article 290 of the Treaty in respect of the following: modifications of the
lists of chemicals in Annex I, ï measures
to include a chemical in Parts 1 or 2 of Annex I following final
regulatory action at Community level, Ö inclusion
of Õ 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
pollutants[15]
in Part 1 of Annex V, measures to amend Annex I, including modifications to existing
entries, Ö inclusion
of Õ measures to include
a chemical already subject to an export ban at Union
Community
level in Part 2 of Annex V, Ö modifications
of Õ measures to amend
Annexes II, III, IV and VI, and Ö modifications
of Õ 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,
ê 689/2008
recital (21) (adapted)
ð new
(2421) ð In order to ensure uniform
conditions ï 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 Ö should
be Õ conferred on
the Commission[16].
ð 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 powers[17]. ï
ò 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.
ò new
(26)     Regulation
(EC) No 689/2008 should be repealed.
ò new
(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,
ê 689/2008
HAVE ADOPTED THIS REGULATION:
ê 689/2008
Article 1
ð new
Article 1
Objectives
1.                      
The objectives of this Regulation are the
following:
(a)     to implement the Rotterdam Convention
on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and
Pesticides in International Trade, hereinafter ‘the Convention’;
(b)     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.
2.                      
In addition to the objectives referred to in
paragraph 1, this Regulation shall ensure that the provisions of
Council Directive 67/548/EEC[18]
and of Directive
1999/45/EC of the European Parliament and of the Council[19] 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 ð and, where applicable, Regulation
(EC) No 1272/2008 of the European Parliament and of the Councilï 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.
ê 689/2008
Article 2
ð new
Article 2
Scope
1.                      
This Regulation shall apply to the following:
(a)     certain hazardous chemicals that are
subject to the prior informed consent procedure under the Convention,
hereinafter ‘the PIC procedure’;
(b)     certain hazardous chemicals that are
banned or severely restricted within the Union
Community
or a Member State;
(c)     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)     narcotic drugs and psychotropic
substances covered by Council Regulation (EC) No 111/2005[20] of
22 December 2004 laying down rules for the monitoring of trade between the
Community and third countries in drug precursors;
(b)     radioactive materials and substances
covered by Council Directive 96/29/Euratom[21]
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 Council[22]
of
5 April 2006 on waste and Council Directive
91/689/EEC[23]
of
12 December 1991 on hazardous waste;
(d)     chemical weapons covered by Council
Regulation (EC) No 1334/2000[24]
of
22 June 2000 setting up a Community regime for the control of exports of
dual-use items and technology;
(e)     food and food additives covered by
Regulation (EC) No 882/2004 of the European Parliament and of the Council[25] 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;
(f)      feedingstuffs covered by Regulation
(EC) No 178/2002 of the European Parliament and of the Council[26] 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 Council[27] 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
Council[28]
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 Council[29]
of
6 November 2001 on the Community code relating to veterinary medicinal
products.
3.                      
(i)      ð This Regulation shall not apply to ï chemicals in quantities not likely to affect health or the
environment, and in any event not more than 10 kg ð per year, per exporter and per
importing country ï, provided that they are imported or exported for the purpose of
research or analysis.
ð 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. ï
ê 689/2008
Article 3 (adapted)
ð new
Article 3
Definitions
For the purposes of this Regulation, the
following definitions shall apply:
1.                      
‘chemical’ means a substance as defined in Directive
67/548/EEC, whether by itself or in a Ö mixture Õ preparation,
or a Ö mixture Õ preparation,
whether manufactured or obtained from nature, but does not include living
organisms, which belongs to either of the following categories:
(a)     pesticides, including severely
hazardous pesticide formulations;
(b)     industrial chemicals;
2.                      
ð 'substance' means any chemical
element and its compounds as defined in point 1 of Article 3 of Regulation (EC)
No 1907/2006; ï
3.                      
2.      ‘ Ö mixture Õ preparation’
means a mixture or a solution Ö as
defined in point 8 of Article 2 of Regulation (EC) No 1272/2008 Õ composed of two or more
substances;
4.                      
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 ð where that product does not fall
under points 2 or 3 ï ;
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 Council[30]
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 Council[31] 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;
6.                      
5.      ‘industrial chemicals’ means chemicals in either of the
following subcategories:
(a)     chemicals for use by professionals;
(b)     chemicals for use by the public;
7.                      
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;
8.                      
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 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.                      
8.      ‘chemical subject to the PIC procedure’ means any chemical
listed in Annex III to the Convention and in Part 3 of Annex I to
this Regulation;
10.                  
9.      ‘banned chemical’ means either of the following:
(a)     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;
(b)     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)     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;
(b)     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;
12.                  
11.    ‘chemical banned or severely restricted by a Member State’
means any chemical that is banned or severely restricted by national final
regulatory action of a Member State;
13.                  
12.    ‘final regulatory action’ means a Ö legally
binding Õ legislative
act the purpose of which is to ban or severely restrict a chemical;
14.                  
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;
15.                  
ð ‘customs territory of the Union’
means the territory as determined in Article 3 of Council Regulation (EEC) No
2913/92[32]. ï
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;
(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.                  
17.    ‘importer’ means any natural or legal person who at the time of
import into the customs territory of the Union
Community
is the consignee for the chemical;
20.                  
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.
ê 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.
ê 689/2008
Article 5 (adapted)
ð new
Article 5
Participation of the Union Community
in the Convention
1.                      
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.
2.                      
12. Ö The
Commission shall act as a common designated authority Õ 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)     the preparation of the Conference of
the Parties established by Article 18 of the Convention;
(c)     the Chemical Review Committee
established in accordance with Article 18(6) of the Convention;
(d)     other subsidiary bodies.
A network of Member State
rapporteurs shall be established, as appropriate, to deal with the preparation
of technical documents such as decision guidance documents as referred to in
Article 7(3) of the Convention.
3.                      
23. The Commission
and the Member States shall take the necessary initiatives to ensure appropriate
ð coordination ï representation of the Community
in the various bodies implementing the Convention.
ò 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.
ê 689/2008
Article 6
ð new
Article 76
Chemicals subject to export notification, chemicals qualifying for PIC
notification, and chemicals subject to the PIC procedure
1.                      
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.
2.                      
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 ð means of the Agency's Database
available on its website ï electronic means.
ê 689/2008
Article 7 (adapted)
ð new
Article 87
Export notifications forwarded to Parties and other countries
1.                      
In the case of substances listed in Part 1 of
Annex I or Ö mixtures Õ preparations
containing such substances in a concentration that ð triggers ï could trigger labelling
obligations under Directive 1999/45/EC ð and, where applicable, under Regulation
(EC) No 1272/2008 ï irrespective of the presence of any other substances,
paragraphs 2 to 8 shall apply.
2.                      
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 Ö 20 working Õ 30 days
before the export of the chemical is due to take place. Thereafter the exporter
shall notify the designated national authority of the first export of such
chemical each calendar year no later than ð 20 working ï 15 days before the export
takes place. The notifications
shall comply with the requirements set out in Annex II ð and shall be made available by means
of the Agency's Database on its website ï .
The designated national authority shall check
compliance of the information with Annex II and promptly forward the
notification received from the exporter to the ð Agency within 5 working days ï Commission.
The ð Agency ï Commission shall take the measures
necessary to ensure that ð , on behalf of the Commission, transmit
the notification to ï the designated national authority of the importing Party or the
appropriate authority of the importing other country and
Ö take the
measures necessary to ensure that they Õ receive Ö that Õ notification no
later than Ö 10 working Õ 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.
ð The Agency shall register ïeach Each export notification shall be registered
and Ö assign it Õ assigned
an export
a reference identification number
in Ö its Õ a Database. database at the Commission, ð The Agency ï Ö shall
also make available to the public and the designated national authorities of
the Member States, as appropriate, Õ and
an updated list of the chemicals concerned and the importing Parties and other
countries for each calendar year ð by means of the Database on its
website ï shall
be kept available to the public and distributed to the designated national
authorities of the Member States as appropriate.
3.                      
If the ð Agency ï 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 Ö 20 working Õ 30 days
of the dispatch of such notification, it shall ð , on behalf of the Commission, ï submit a second notification. The ð Agency ï Commission shall ð , on behalf of the Commission, ï 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.
4.                      
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 Ö mixture Õ preparation
in question changes so that the labelling of such Ö mixture Õ 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.
5.                      
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 ð the duly justified request of the
exporter or the importing Party or other country and at ï the discretion of the designated national authority of the
exporting Member State, in consultation with the Commission ð assisted by the Agency ï .
6.                      
ð Without prejudice to the obligations
set out in paragraphs 2 and 3 of Article 19, the ï The obligations set out
in paragraphs 2, 3 and 4 Ö of this
Article Õ 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 ð and the Agency ï;
Ö However,
the obligations set out in paragraphs 2, 3 and 4 of this Article shall not
cease Õ 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.
ð Without prejudice to the obligations
set out in paragraphs 2 and 3 of Article 19, the ï The obligations set out
in paragraphs 2, 3 and 4 Ö of this
Article Õ shall also
cease when the following conditions are fulfilled:
(a)     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;
(b)     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 ð and the Agency, which ï and made it available ð by means of the Database on its
website ï on the Internet.
7.                      
The Commission, the relevant designated national
authorities of the Member States, ð the Agency ï and the exporters shall provide importing Parties and other
countries with available additional information concerning the exported
chemicals, when requested.
8.                      
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 Ö they
incur in Õ 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).
ê 689/2008
Article 8
ð new
Article 98
Export notifications received from Parties and other countries
1.                      
Export notifications received by the ð Agency ï Commission from the
designated national authorities of Parties or the appropriate authorities of
other countries 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 ð by means of the Agency's Database on
its website ï by electronic means through the database
maintained by the Commission.
The ð Agency ï Commission shall ð , on behalf of the Commission, ï 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 ð by the Agency ï together with all available information. Other Member States shall
be entitled to receive copies on request.
2.                      
Should ð the Commission or ï 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 ð Agency ï Commission together with
all available information.
ê 689/2008
Article 9 (adapted)
ð new
Article 109
Information on export and import of chemicals
1.                      
Each exporter of:
(a-)    substances
listed in Annex I,
(b-)   Ö mixtures Õ preparations
containing such substances in a concentration that ð triggers ï could trigger labelling
obligations under Directive 1999/45/EC ð and, where applicable, under Regulation
(EC) No 1272/2008 ï irrespective of the presence of any other substances, or
(c-)    articles
containing substances listed in Parts 2 or 3 of Annex I in unreacted form
or Ö mixtures Õ preparations
containing such substances in a concentration that ð triggers ï could trigger labelling
obligations under Directive 1999/45/EC ð and, where applicable, under Regulation
(EC) No 1272/2008 ï 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 Ö mixtures Õ 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).
Each importer within the Union Community shall
provide the same information for the quantities imported into the Union Community.
2.                      
Upon request from the Commission or the
designated national authority of its Member State ð or the Agency ï, the exporter or importer shall provide any additional information
relating to chemicals that is necessary to implement this Regulation.
3.                      
Each Member State shall provide the ð Agency ï Commission each year with
aggregated information in accordance with Annex III. The ð Agency ï Commission shall
summarise that information at Union
Community
level and shall make the non-confidential information publicly available on its
Ö Database Õ database via the Internet.
ê 689/2008
Article 10 (adapted)
ð new
Article 1110
Notification of banned or severely restricted chemicals under the Convention
1.                      
The Commission shall notify the Secretariat in
writing of the chemicals that qualify for PIC notification.
2.                      
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.
3.                      
The notification shall provide all relevant
information as required in Annex IV.
4.                      
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.
Ö Where Õ 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.
5.                      
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.
6.                      
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 ð and the Agency ï shall, upon request, assist the Commission as necessary in
compiling that information.
7.                      
The Commission shall forward immediately to the
Member States ð and the Agency ï 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 ð and the Agency ï, 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.
8.                      
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.
ê 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
Ö Where Õ 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.
ê 689/2008
Article 12
ð new
Article 132
Obligations in relation to imports of chemicals
1.                      
The Commission shall immediately forward to the
Member States ð and the Agency ï 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 accordance with
the advisory procedure referred to in Article 294(2) and
communicate the revised import decision to the Secretariat.
2.                      
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.
3.                      
An import decision under paragraph 1 shall
relate to the category or categories specified for the chemical in the decision
guidance document.
4.                      
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.
5.                      
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. ð The Agency shall make the import
decisions under paragraph 1 publicly available on its Database. ï
6.                      
Where appropriate, the Commission shall
evaluate, in close cooperation with the Member States ð and the Agency ï, 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.
ê 689/2008
Article 13 (adapted)
ð new
Article 143
Obligations in relation to exports of chemicals other than export notification
requirements
1.                      
The Commission shall immediately forward to the
Member States ð , the Agency ï 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 ð and the Agency ï information concerning any cases of failure to transmit a response
in accordance with Article 10(2) of the Convention. The ð Agency ï Commission Ö shall
assign each import decision a reference identification number and keep Õ 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 Ö its
website Õ the Internet,
and provide anyone with that information upon request.
2.                      
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.
3.                      
Each Member State shall communicate the
responses forwarded by the Commission under paragraph 1 to those concerned
within its jurisdiction.
4.                      
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.
5.                      
The Commission ð , assisted by the Agency, ï and the Member States shall advise and assist importing Parties,
upon request and as appropriate, Ö in obtaining Õ to obtain
further information Ö needed to
prepare Õ to help them to make
a response to the Secretariat concerning the
import of a given chemical.
6.                      
Substances listed in Parts 2 or 3 of
Annex I or Ö mixtures Õ preparations
containing such substances in a concentration that ð triggers ï could trigger labelling
obligations under Directive 1999/45/EC ð and, where applicable, under Regulation
(EC) No 1272/2008 ï 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 ð , assisted by the Agency, ï and the designated national authority of the importing Party or an
appropriate authority in an importing other country;
(b)     in the case of chemicals listed in
Part 3 of Annex I, the latest circular issued by the Secretariat pursuant
to paragraph 1 indicates that the importing Party has given consent to
import.
In the case of chemicals listed in Part 2 of
Annex I that are to be exported to OECD countries, the designated national
authority of the exporter may, ð at the request of the
exporter, ï 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 ð Agency ï Commission or the designated national authority of
the exporter has not received a response to Ö the Õ its
request within 30 days, the ð Agency ï Commission shall ð , on behalf of the Commission, ï send a reminder ð unless the Commission or the
designated national authority received a response and forwarded it to the
Agency ï. Where appropriate, if there is still no response within a further
30 days, the ð Agency ï 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 ð assisted by the Agency ï 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 ð 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. ï
When deciding on the export of chemicals listed
in Part 3 of Annex I, the designated national authority in consultation
with the Commission ð assisted by the Agency ï 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.
9.                      
The ð Agency ï 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 Ö a Õ an explicit consent
reference identification number and shall be listed with all relevant
information concerning any conditions attached, Ö such as Õ validity dates, etc.
The non-confidential information shall be made publicly available on the ð Agency's Database ï Internet.
10.                  
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.
11.                  
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.
ê 689/2008
Article 14 (adapted)
ð 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
Ö if they
contain any of the following: Õ 
Ö a)
substances listed in Parts 2 or 3 of Annex I in unreacted form; Õ 
Ö b)
mixtures containing such substances in a concentration that Õ ð triggers ï Ö labelling
obligations under Directive 1999/45/EC Õ ð and, where applicable, under Regulation
(EC) No 1272/2008 ï Ö irrespective
of the presence of any other substances. Õ 
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.
ê 689/2008
Article 15
ð new
Article 165
Information on transit movements
1.                      
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.
2.                      
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.
3.                      
The designated national authority of the Member
State shall forward to the Commission ð with a copy to the Agency, ï the information received from the exporter under paragraph 2
together with any additional information available.
4.                      
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.
ê 689/2008
Article 16 (adapted)
ð new
Article 176
Information to accompany exported chemicals
1.                      
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 ð and, where applicable, Regulation
(EC) No 1272/2008, ï or any other Ö relevant Õ specific
Union Community
legislation.
ò 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.
ê 689/2008
Article 16 (adapted)
The first Ö two Õ subparagraphs Ö of this
paragraph Õ shall be
without prejudice to any specific requirements of the importing Party or other
country taking into account relevant international standards.
2.                      
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.
3.                      
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 Agency[33]
shall accompany chemicals referred to in paragraph 1 when exported. The
exporter shall send such a safety data sheet to each importer.
4.                      
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.
ê 689/2008
Article 17 (adapted)
ð new
Article 187
Obligations of the authorities of the Member States and exporters for controlling
imports and exports
1.                      
Each Member State shall designate authorities
such as customs authorities that shall have the responsibility of controlling
the import and export of chemicals listed in Annex I, unless it has
already done so before the entry into force of this Regulation.
The Commission,
and
the Member States ð and the Agency ï shall act in a targeted and coordinated way in monitoring
exporters' compliance with this Regulation. 
ò new
2.                      
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. 
ê 689/2008
Article 17
3.                      
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.
ê 689/2008
Article 17 (adapted)
ð new
ð Article 19
Obligations of exporters for controlling imports and exports ï
1.                      
Exporters ð of chemicals subject to the
obligations set out in paragraphs 2 and 4 of Article 8 ï shall provide Ö the
applicable reference identification numbers Õ 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 Code[34] 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.
ò new
2.                      
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.
3.                      
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.
4.                      
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.
ê 689/2008
Article 19
ð new
Article 2019
Exchange of information
1.                      
The Commission ð , assisted by the Agency, ï 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 ð and the Agency ï as necessary, shall, as appropriate, ensure:
(a)     the provision of publicly available
information concerning regulatory actions relevant to the objectives of the
Convention; and
(b)     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.
2.                      
The Commission,
and
the Member States ð and the Agency ï shall protect any confidential information received from a Party or
other country as mutually agreed.
3.                      
As regards the transmission of information under
this Regulation, and without prejudice to Directive 2003/4/EC of the European
Parliament and of the Council[35]
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 concerning precautionary
measures, including hazard classification, the nature of the risk and the
relevant safety advice;
(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 ð Agency ï Commission on the
basis of the contributions by Member States ð and the Commission ï.
ê 689/2008
Article 20 (adapted)
ð new
Article 2120
Technical assistance
The Commission,and the designated national authorities
of the Member States ð and the Agency ï 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.
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 ð international activities in capacity-building
in chemicals management ï 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.
ê 689/2008
Article 21
ð new
Article 2221
Monitoring and reporting
1.                      
Member States ð and the Agency ï 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, ð as appropriate ï.
2.                      
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 ð and the Agency ï 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.
3.                      
As regards the information supplied pursuant to
paragraphs 1 and 2, the Member States ð , the Agency ï and the Commission shall comply with relevant obligations to
protect the confidentiality of data and ownership.
ê 689/2008
Article 22 (adapted)
ð 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.
2.                      
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.
3.                      
The decision to include chemicals in
Annex I, or to amend their entry where appropriate, shall be taken without
undue delay.
4.                      
ð 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: ï 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)     Ö inclusion
of Õ 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 Ö and
amendments of Annex I, including modifications to existing entries Õ ;
(b)     Ö inclusion
of Õ measures to include
a chemical that is subject to Regulation (EC) No 850/2004 of the European Parliament and of the Council[36] in Part 1 of Annex V;
(c)     other
measures to amend Annex I, including modifications to existing entries;
(cd)   Ö inclusion
of Õ measures to include
a chemical already subject to an export ban at Union
Community
level in Part 2 of Annex V;
(df)    Ö modifications
to Õ measures to modify
existing entries in Annex V.;
(e)     Ö amendments
of Õ measures to amend
Annexes II, III, IV and VI.;
ê 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.
The technical
notes shall be published in the ‘C’ series of the Official Journal of the European Union.
ò 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.                      
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.
3.                      
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.
ò 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.
ò new
Article 26
Exercise of the delegation
1.                      
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.
2.                      
As soon as it adopts a
delegated act, the Commission shall notify it simultaneously to the European
Parliament and to the Council.
3.                      
The powers to adopt
delegated acts are conferred on the Commission subject to the conditions laid
down in Articles 27 and 28.
ò new
Article 27
Revocation of the delegation
1.                      
The delegation of
power referred to in Article 23(4) may be revoked at any time by the European
Parliament or by the Council.
2.                      
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.
3.                      
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.
ò new
Article 28
Objections to delegated acts
1.                      
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.
2.                      
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.
3.                      
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.
ê 689/2008
Article 24 (adapted)
ð new
Article 294
Committee
1.                      
The Commission shall be assisted by the
committee established by Article 133 of Regulation (EC) No 1907/2006.
ð That committee shall be a committee
within the meaning of Regulation (EU) No 182/2011. ï
2.                      
Where reference is made to this paragraph,
Article 3 and
Article 7 ð of Regulation (EU) No 182/2011 ï of Decision 1999/468/EC shall
apply, having
regard to the provisions of Article 8 thereof.
3.                      
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.
ò 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.
ê 689/2008
Article 18 (adapted)
Article 3118
Penalties
Member States shall Ö lay down
the rules on Õ determine the
penalties applicable to infringements of the provisions of this Regulation and Ö shall Õ take all
measures necessary to ensure correct implementation of these provisions. The
penalties Ö provided
for must Õ 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 Ö those
provisions to Õ the Commission
of those measures
by [OJ: please insert the date: 1 year
after publication] 1 August 2009.Ö at the
latest and Õ They shall
also
notify it Ö without
delay Õ of any Ö subsequent
amendment affecting them Õ further modifications as
soon as possible after their adoption.
Member States shall make all information
regarding penalties available upon request.
ê 689/2008
Article 25 (adapted)
ð new
Article 3225
 ð Repeal ï References to Regulation (EC) No 304/2003
ð Regulation (EC) No 689/2008 shall be
repealed with effect from 31 March 2013. ï
References to
Regulation (EC) No Ö 689/2008 Õ 304/2003
shall be construed as
references to this Regulation ð and shall be read in accordance
with the correlation table in Appendix 1 ï.
ê 689/2008
Article 26 (adapted)
ð new
Article 3326
Entry into force
This Regulation shall enter into force on
the ð twentieth ï day following Ö that of Õ its
publication in the Official Journal of the European Union.
Article 17(2), however, shall apply as
from 1 November 2008.
ð This Regulation shall apply as from
1 April 2013. ï 
This Regulation shall be binding
in its entirety and directly applicable in all Member States.
Ö It shall
be binding in its entirety and directly applicable in all Member States. Õ 
Done at […],
For the European Parliament                       For
the Council
The
President                                                 The President
ê 689/2008 Annex
I (adapted)
è1 15/2010 Art. 1 and Annex .1(a)
è2 196/2010 Art. 1 and Annex .1(a)
è3 196/2010 Art. 1 and Annex .1(b)
è4 15/2010 Art. 1 and Annex .1(b)
è5 15/2010 Art. 1 and Annex .2(a)
è6 196/2010 Art. 1 and Annex .2(b)
è7 196/2010 Art. 1 and Annex .2(a)
è8 15/2010 Art. 1 and Annex .2(b)
è9 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 Ö points Õ Article 7(6) (b) and (c) Ö of Article 8(6) Õ 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 notification is required 
 1,1,1-Trichloroethane || 71-55-6 || 200-756-3 || 29031910 || i(2) || b ||   
 1,2-Dibromoethane (Ethylene dibromide) # || 106-93-4 || 203-444-5 || 29033100 || p(1)-p(2) || b-b || Please refer to PIC circular at www.pic.int/ 
 1,2-Dichloroethane (ethylene dichloride) # || 107-06-2 || 203-458-1 || 29031500 || p(1)-p(2) || b-b || Please refer to PIC circular at www.pic.int/ 
   || i(2) || b ||   
 Cis- 1,3-dichloropropene ((1Z)-1,3-dichloroprop-1-ene) || 10061-01-5 || 233-195-8 || 29032900 || p(1)-p(2) || b-b ||   
 è1 1,3-dichloropropene[37] ç || è1 542-75-6 ç || è1 208-826-5 ç || è1 29032900 ç || è1 p(1) ç || è1 b ç ||   
 2-aminobutane || 13952-84-6 || 237-732-7 || 29211980 || p(1)-p(2) || b-b ||   
 2-Naphthylamine (naphthalen-2-amine) and its salts + || 91-59-8, 553-00-4, 612-52-2 and others || 202-080-4, 209-030-0, 210-313-6 and others || 29214500 || i(1) || b ||   
   || i(2) || b ||   
 è2 2-Naphthyloxyacetic acid ç || è2 120-23-0 ç || è2 204-380-0 ç || è2 29189990 ç || è2 p(1) ç || è2 b ç ||   
 2,4,5-T and its salts and esters # || 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, 2113-61-3 and others || 202-177-1 and others || 29214980 || i(1) || b ||   
   || i(2) || b ||   
 4-Nitrobiphenyl + || 92-93-3 || 202-204-7 || 29042000 || i(1) || b ||   
   || i(2) || b ||   
 Acephate + || 30560-19-1 || 250-241-2 || 29309085 || p(1)-p(2) || b-b ||   
 Acifluorfen || 50594-66-6 || 256-634-5 || 29163900 || p(1)-p(2) || b-b ||   
 Alachlor + || 15972-60-8 || 240-110-8 || 29242995 || p(1) || b ||   
 Aldicarb + || 116-06-3 || 204-123-2 || 29309085 || p(1)-p(2) || sr-b ||   
 Ametryn || 834-12-8 || 212-634-7 || 29336980 || p(1)-p(2) || b-b ||   
 è3 Amitraz + ç || è3 33089-61-1 ç || è3 251-375-4 ç || è3 29252900 ç || è3 p(1)-p(2) ç || è3 b-b ç ||   
 è2 Anthraquinone ç || è2 84-65-1 ç || è2 201-549-0 ç || è2 29146100 ç || è2 p(1)-p(2) ç || è2 b-b ç ||   
 Arsenic compounds ||   ||   ||   || p(2) || sr ||   
 Asbestos Fibres +: || 1332-21-4 and others ||   ||   ||   ||   || Please refer to PIC circular at www.pic.int/ 
 Crocidolite # || 12001-28-4 ||   || 25241000 || i || b ||   
 Amosite # || 12172-73-5 ||   || 25249000 || i || b ||   
 Antophyllite # || 77536-67-5 ||   || 25249000 || i || b ||   
 Actinolite # || 77536-66-4 ||   || 25249000 || i || b ||   
 Tremolite # || 77536-68-6 ||   || 25249000 || i || b ||   
 Chrysotile + || 12001-29-5 or 132207-32-0 ||   || 25249000 || i || b ||   
 è3 Atrazine + ç || è3 1912-24-9 ç || è3 217-617-8 ç || è3 29336910 ç || è3 p(1) ç || è3 b ç ||   
 Azinphos-ethyl || 2642-71-9 || 220-147-6 || 29339990 || p(1)-p(2) || b-b ||   
 Azinphos-methyl || 86-50-0 || 201-676-1 || 29339990 || p(1) || b ||   
 è1 Benfuracarb ç || è1 82560-54-1 ç ||   || è1 29329900 ç || è1 p(1) ç || è1 b ç ||   
 Bensultap || 17606-31-4 ||   || 29309085 || p(1)-p(2) || b-b ||   
 Benzene (1) || 71-43-2 || 200-753-7 || 29022000 || i(2) || sr ||   
 Benzidine and its salts + Benzidine derivatives + || 92-87-5, 36341-27-2 and others || 202-199-1, 252-984-8 and others || 29215990 || i(1)-i(2) i(2) || sr-b b ||   
   || — || — ||   ||   ||   ||   
 Binapacryl # || 485-31-4 || 207-612-9 || 29161950 || p(1)-p(2) i(2) || b-b b || Please refer to PIC circular at www.pic.int/ 
 è2 Butralin ç || è2 33629-47-9 ç || è2 251-607-4 ç || è2 29214900 ç || è2 p(1) ç || è2 b ç ||   
 Cadmium and its compounds || 7440-43-9 and others || 231-152-8 and others || 8107 32064930 and others || i(1) || sr ||   
 Cadusafos + || 95465-99-9 || n.a. || 29309085 || p(1) || b ||   
 Calciferol || 50-14-6 || 200-014-9 || 29362990 || p(1) || b ||   
 Captafol # || 2425-06-1 || 219-363-3 || 29305000 || p(1)-p(2) || b-b || Please refer to PIC circular at www.pic.int/ 
 Carbaryl + || 63-25-2 || 200-555-0 || 29242995 || p(1)-p(2) || b–b ||   
 Carbofuran + || 1563-66-2 || 216-353-0 || 29329985 || p(1) || b ||   
 Carbon tetrachloride || 56-23-5 || 200-262-8 || 29031400 || i(2) || b ||   
 Carbosulfan + || 55285-14-8 || 259-565-9 || 29329985 || p(1) || b ||   
 Cartap || 15263-53-3 ||   || 29302000 || p(1)-p(2) || b-b ||   
 Chinomethionat || 2439-01-2 || 219-455-3 || 29349990 || p(1)-p(2) || b-b ||   
 Chlordecone || 143-50-0 || 205-601-3 || 29147000 || p(2) || sr ||   
 Chlordimeform # || 6164-98-3 || 228-200-5 || 29252100 || p(1)-p(2) || b-b || Please refer to PIC circular at www.pic.int/ 
 Chlorfenapyr + || 122453-73-0 ||   || 29339990 || p(1) || b ||   
 Chlorfenvinphos || 470-90-6 || 207-432-0 || 29199090 || p(1)-p(2) || b-b ||   
 Chlormephos || 24934-91-6 || 246-538-1 || 29309085 || p(1)-p(2) || b-b ||   
 Chlorobenzilate # || 510-15-6 || 208-110-2 || 29181800 || p(1)-p(2) || b-b || Please refer to PIC circular at www.pic.int/ 
 Chloroform || 67-66-3 || 200-663-8 || 29031300 || i(2) || b ||   
 Chlozolinate + || 84332-86-5 || 282-714-4 || 29349990 || p(1)-p(2) || b-b ||   
 Cholecalciferol || 67-97-0 || 200-673-2 || 29362990 || p(1) || b ||   
 Coumafuryl || 117-52-2 || 204-195-5 || 29322985 || p(1)-p(2) || 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 ||   ||   ||   ||   
 Crimidine || 535-89-7 || 208-622-6 || 29335995 || p(1) || b ||   
 Cyanazine || 21725-46-2 || 244-544-9 || 29336980 || p(1)-p(2) || b-b ||   
 Cyhalothrine || 68085-85-8 || 268-450-2 || 29269095 || p(1) || b ||   
 DBB (Di-μ-oxo-di-n-butylstannio-hydroxyborane/dioxastannaboretan-4-ol) || 75113-37-0 || 401-040-5 || 29310095 || i(1) || b ||   
 Diazinon || 333-41-5 || 206-373-8 || 29335910 || p(1) || b ||   
 Dichlorvos || 62-73-7 || 200-547-7 || 29199090 || p(1) || b ||   
 è2 Dicofol ç || è2 115-32-2 ç || è2 204-082-0 ç || è2 29062900 ç || è2 p(1)-p(2) ç || è2 b-b ç ||   
 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 + || 87674-68-8 || n.a. || 29349990 || p(1) || b ||   
 è2 Diniconazole-M ç || è2 83657-18-5 ç || è2 n.a. ç || è2 29339980 ç || è2 p(1) ç || è2 b ç ||   
 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 || 208-601-1 221-037-0 — 219-007-7 || 29089990 || p(1)-p(2) || b-b || Please refer to PIC circular at www.pic.int/ 
 Dinobuton || 973-21-7 || 213-546-1 || 29209010 || p(1)-p(2) || b-b ||   
 Dinoseb and its salts and esters # || 88-85-7 and others || 201-861-7 nd others || 29089100 29153600 || p(1)-p(2) i(2) || b-b b || Please refer to PIC circular at www.pic.int/ 
 Dinoterb + || 1420-07-1 || 215-813-8 || 29089990 || p(1)-p(2) || b-b ||   
 è4 --- ç || è4 --- ç || è4 --- ç || è4 --- ç || è4 --- ç || è4 --- ç ||   
 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) || b ||   
 Carbofuran at or above 10 % || 1563-66-2 || 216-353-0 || 29329985 || p(2) || b ||   
 and Thiram at or above 15 % # || 137-26-8 || 205-286-2 || 29303000 ||   ||   ||   
 Endosulfan + || 115-29-7 || 204-079-4 || 29209085 || p(1) || b ||   
 Ethion || 563-12-2 || 209-242-3 || 29309085 || p(1)-p(2) || b-b ||   
 Ethylene oxide (Oxirane) # || 75-21-8 || 200-849-9 || 29101000 || p(1) || b || Please refer to PIC circular at www.pic.int/ 
 è1 Fenarimol + ç || è1 60168-88-9 ç || è1 262-095-7 ç || è1 29335995 ç || è1 p(1) ç || è1 b ç ||   
 Fenitrothion || 122-14-5 || 204-524-2 || 29201900 || p(1) || b ||   
 Fenpropathrin || 39515-41-8 || 254-485-0 || 29269095 || p(1)-p(2) || b-b ||   
 Fenthion + || 55-38-9 || 200-231-9 || 29309085 || p(1) || sr ||   
 Fentin acetate + || 900-95-8 || 212-984-0 || 29310095 || p(1)-p(2) || b-b ||   
 Fentin hydroxide + || 76-87-9 || 200-990-6 || 29310095 || p(1)-p(2) || b-b ||   
 Fenvalerate || 51630-58-1 || 257-326-3 || 29269095 || p(1) || b ||   
 Ferbam || 14484-64-1 || 238-484-2 || 29302000 || p(1)-p(2) || b-b ||   
 Fluoroacetamide # || 640-19-7 || 211-363-1 || 29241200 || p(1) || b || Please refer to PIC circular at www.pic.int/ 
 Flurenol || 467-69-6 || 207-397-1 || 29181985 || p(1)-p(2) || b-b ||   
 è2 Flurprimidol ç || è2 56425-91-3 ç || è2 n.a. ç || è2 29335995 ç || è2 p(1) ç || è2 b ç ||   
 Furathiocarb || 65907-30-4 || 265-974-3 || 29329985 || p(1)-p(2) || b-b ||   
 Haloxyfop-R + || 95977-29-0 || n.a. || 29333999 || p(1) || 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) || sr ||   
 Hexazinone || 51235-04-2 || 257-074-4 || 29336980 || p(1)-p(2) || b-b ||   
 Iminoctadine || 13516-27-3 || 236-855-3 || 29252900 || p(1)-p(2) || b-b ||   
 Isoxathion || 18854-01-8 || 242-624-8 || 29349990 || p(1) || 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) || b ||   
 (a) Maleic hydrazide, and its salts, other than choline, potassium and sodium salts || 123-33-1 || 204-619-9 || 29339990 || p(1) || b ||   
 (b) Choline, potassium and sodium salts of maleic hydrazide containing more than 1 mg/kg of free hydrazine expressed on the basis of the acid equivalent || 61167-10-0, 51542-52-0, 28330-26-9 || 257-261-0, 248-972-7 || 29339990 ||   ||   ||   
 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/ 
 è1 Methamidophos[38] + ç || è1 10265-92-6 ç || è1 233-606-0 ç || è1 29305000 ç || è1 p(1) ç || è1 b ç ||   
 Methamidophos (Soluble liquid formulations of the substance that exceed 600 g active ingredient/l) # || 10265-92-6 || 233-606-0 || 29305000 38085000 || p(2) || b || Please refer to PIC circular at www.pic.int/ 
 Methidathion || 950-37-8 || 213-449-4 || 29349990 || p(1)-p(2) || b-b ||   
 è1 Methomyl ç || è1 16752-77-5 ç || è1 240-815-0 ç || è1 29309085 ç || è1 p(1)-p(2) ç || è1 b-b ç ||   
 Methyl-parathion + # || 298-00-0 || 206-050-1 || 29201100 || p(1)-p(2) || b-b || Please refer to PIC circular at www.pic.int/ 
 Metoxuron || 19937-59-8 || 243-433-2 || 29242190 || p(1)-p(2) || b-b ||   
 Monocrotophos # || 6923-22-4 || 230-042-7 || 29241200 || p(1)-p(2) || b-b || Please refer to PIC circular at www.pic.int/ 
 Monolinuron || 1746-81-2 || 217-129-5 || 29280090 || p(1) || b ||   
 Monomethyl-dibromo-diphenyl methane Tradename: DBBT + || 99688-47-8 || 402-210-1 || 29036990 || i(1) || b ||   
 Monomethyl-Dichloro-Diphenyl methane; Tradename: Ugilec 121 or Ugilec 21 + || — || 400-140-6 || 29036990 || i(1)-i(2) || b-b ||   
 Monomethyl-Tetrachlorodiphenyl methane; Tradename: Ugilec 141 + || 76253-60-6 || 278-404-3 || 29036990 || i(1)-i(2) || b-b ||   
 Monuron || 150-68-5 || 205-766-1 || 29242190 || p(1) || b ||   
 è2 Nicotine ç || è2 54-11-5 ç || è2 200-193-3 ç || è2 29399900 ç || è2 p(1) ç || è2 b ç ||   
 Nitrofen + || 1836-75-5 || 217-406-0 || 29093090 || p(1)-p(2) || b-b ||   
 Nonylphenols C6H4(OH)C9H19 + || 25154-52-3 (phenol, nonyl-), || 246-672-0 || 29071300 || i(1) || sr ||   
   || 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 ||   ||   ||   ||   
 Nonylphenol ethoxylates (C2H4O)nC15H24O + || 9016-45-9, 26027-38-3, 68412-54-4, 37205-87-1, 127087-87-0 and others ||   || 34021300 || i(1) p(1)-p(2) || sr b-b ||   
 Octabromodiphenyl ether + || 32536-52-0 || 251-087-9 || 29093038 || i(1) || sr ||   
 Omethoate || 1113-02-6 || 214-197-8 || 29309085 || p(1)-p(2) || b-b ||   
 Oxydemeton-methyl + || 301-12-2 || 206-110-7 || 29309085 || p(1) || b ||   
 è1 Paraquat + ç || è1 4685-14-7 ç || è1 225-141-7 ç || è1 29333999 ç || è1 p(1) ç || è1 b ç ||   
 Parathion # || 56-38-2 || 200-271-7 || 29201100 || p(1)-p(2) || b-b || Please refer to PIC circular at www.pic.int/ 
 Pebulate || 1114-71-2 || 214-215-4 || 29302000 || p(1)-p(2) || b-b ||   
 Pentabromodiphenyl ether + || 32534-81-9 || 251-084-2 || 29093031 || i(1) || sr ||   
 Pentachlorophenol and its salts and esters # || 87-86-5 and others || 201-778-6 and others || 29081100 29081900 and others || p(1)-p(2) || b-sr || 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 ||   ||   ||   
 C8F17SO2X || and others ||   || and others ||   ||   ||   
 (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers) + (a) ||   ||   ||   ||   ||   ||   
 Permethrin || 52645-53-1 || 258-067-9 || 29162000 || p(1) || b ||   
 Phosalone + || 2310-17-0 || 218-996-2 || 29349990 || p(1) || b ||   
 Phosphamidon (soluble liquid formulations of the substance that exceed 1000 g active ingredient/l) # || 13171-21-6 (mixture, (E) & (Z) isomers) || 236-116-5 || 29241200 38085000 || p(1)-p(2) || b-b || Please refer to PIC circular at www.pic.int/ 
   || 23783-98-4 ((Z)-isomer) ||   ||   ||   ||   ||   
   || 297-99-4 ((E)-isomer) ||   ||   ||   ||   ||   
 Polybrominated biphenyls (PBB) # || 13654-09-6 36355-01-8 27858-07-7 and others || 237-137-2 252-994-2 248- 696-7 || 29036990 and others || i(1) || sr || Please refer to PIC circular at www.pic.int/ 
 Polychlorinated terphenyls (PCT) # || 61788-33-8 || 262-968-2 || 29036990 || i(1) || b || Please refer to PIC circular at www.pic.int/ 
 è1 Procymidone + ç || è1 32809-16-8 ç || è1 251-233-1 ç || è1 29251995 ç || è1 p(1) ç || è1 b ç ||   
 è2 Propachlor ç || è2 1918-16-7 ç || è2 217-638-2 ç || è2 29242998 ç || è2 p(1) ç || è2 b ç ||   
 è2 Propanil ç || è2 709-98-8 ç || è2 211-914-6 ç || è2 29242998 ç || è2 p(1) ç || è2 b ç ||   
 Propham || 122-42-9 || 204-542-0 || 29242995 || p(1) || b ||   
 Pyrazophos + || 13457-18-6 || 236-656-1 || 29335995 || p(1)-p(2) || b-b ||   
 Quintozene + || 82-68-8 || 201-435-0 || 29049085 || p(1)-p(2) || b-b ||   
 Scilliroside || 507-60-8 || 208-077-4 || 29389090 || p(1) || b ||   
 è3 Simazine + ç || è3 122-34-9 ç || è3 204-535-2 ç || è3 29336910 ç || è3 p(1)-p(2) ç || è3 b-b ç ||   
 Strychnine || 57-24-9 || 200-319-7 || 29399900 || p(1) || b ||   
 Tecnazene + || 117-18-0 || 204-178-2 || 29049085 || p(1)-p(2) || b-b ||   
 Terbufos || 13071-79-9 || 235-963-8 || 29309085 || p(1)-p(2) || b-b ||   
 Tetraethyl lead # || 78-00-2 || 201-075-4 || 29310095 || i(1) || sr || Please refer to PIC circular at www.pic.int/ 
 Tetramethyl lead # || 75-74-1 || 200-897-0 || 29310095 || i(1) || sr || Please refer to PIC circular at www.pic.int/ 
 Thallium sulphate || 7446-18-6 || 231-201-3 || 28332990 || p(1) || b ||   
 Thiocyclam || 31895-22-4 || 250-859-2 || 29349990 || p(1)-p(2) || b-b ||   
 Thiodicarb + || 59669-26-0 || 261-848-7 || 29309085 || p(1) || b ||   
 è1 Tolylfluanid + ç || è1 731-27-1 ç || è1 211-986-9 ç || è1 29309085 ç || è1 p(1) ç || è1 b ç ||   
 Triazophos || 24017-47-8 || 245-986-5 || 29339990 || p(1)-p(2) || b-b ||   
 è2 All tributyltin compounds, including: ç ||   ||   || è2 29310095 ç || è2 p(2) ç || è2 b ç || è2 Please refer to PIC circular at www.pic.int/ ç 
 è2 Tributyltin oxide ç || è2 56-35-9 ç || è2 200-268-0 ç || è2 29310095 ç 
 è2 Tributyltin fluoride ç || è2 1983-10-4 ç || è2 217-847-9 ç || è2 29310095 ç 
 è2 Tributyltin methacrylate ç || è2 2155-70-6 ç || è2 218-452-4 ç || è2 29310095 ç 
 è2 Tributyltin benzoate ç || è2 4342-36-3 ç || è2 224-399-8 ç || è2 29310095 ç 
 è2 Tributyltin chloride ç || è2 1461-22-9 ç || è2 215-958-7 ç || è2 29310095 ç 
 è2 Tributyltin linoleate ç || è2 24124-25-2 ç || è2 246-024-7 ç || è2 29310095 ç 
 è2 Tributyltin naphthenate # ç || è2 85409-17-2 ç || è2 287-083-9 ç || è2 29310095 ç 
 Trichlorfon + || 52-68-6 || 200-149-3 || 29310095 || p(1)-p(2) || b-b ||   
 è2 Tricyclazole ç || è2 41814-78-2 ç || è2 255-559-5 ç || è2 29349990 ç || è2 p(1) ç || è2 b ç ||   
 Tridemorph || 24602-86-6 || 246-347-3 || 29349990 || p(1)-p(2) || b-b ||   
 è1 Trifluralin ç || è1 1582-09-8 ç || è1 216-428-8 ç || è1 29214300 ç || è1 p(1) ç || è1 b ç ||   
 è3 Triorganostannic compounds other than tributyltin compounds + ç || è3 — ç || è3 — ç || è3 29310095 and others ç || è3 p(2) i(2) ç || è3 sr sr ç ||   
 Tris (2,3-Dibromopropyl) phosphate # || 126-72-7 || 204-799-9 || 29191000 || i(1) || sr || Please refer to PIC circular at www.pic.int/ 
 Tris-aziridinyl-phosphinoxide (1,1’,1’-phosphoryltriaziridine) + || 545-55-1 || 208-892-5 || 29339990 || i(1) || sr ||   
 Vamidothion || 2275-23-2 || 218-894-8 || 29309085 || p(1)-p(2) || b-b ||   
 Vinclozolin || 50471-44-8 || 256-599-6 || 29349990 || p(1) || b ||   
 Zineb || 12122-67-7 || 235-180-1 || 29302000 or 38249097 || p(1) || b ||   
(*)                     Sub-
Category: p(1) – pesticide in the group of plant protection products, p(2) –
other pesticide including biocides. i(1) - industrial chemical for professional
use and i(2) – industrial chemical for public use.
(**)                  Use
limitation: sr - severe restriction, b – ban (for the sub-category or
sub-categories concerned) according to Union Community legislation.
(1)               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.
            
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 || i || b 
 4-Aminobiphenyl (biphenyl-4-amine) and its salts || 92-67-1, 2113-61-3 and others || 202-177-1 and others || 29214980 || i || b 
 4-Nitrobiphenyl || 92-92-3 || 202-204-7 || 29042000 || i || b 
 Acephate || 30560-19-1 || 250-241-2 || 29309085 || p || b 
 Alachlor || 15972-60-8 || 240-110-8 || 29242995 || p || b 
 Aldicarb || 116-06-3 || 204-123-2 || 29309085 || p || sr 
 è5 Amitraz ç || è5 33089-61-1 ç || è5 251-375-4 ç || è5 29252900 ç || è5 p ç || è5 b ç 
 è6 Anthraquinone ç || è6 84-65-1 ç || è6 201-549-0 ç || è6 29146100 ç || è6 p ç || è6 b ç 
 Asbestos fibres: Chrysotile || 12001-29-5 or 132207-32-0 ||   || 25249000 || i || b 
 è5 Atrazine ç || è5 1912-24-9 ç || è5 217-617-8 ç || è5 29336910 ç || è5 p ç || è5 b ç 
 è7 Azinphos-methyl ç || è7 86-50-0 ç || è7 201-676-1 ç || è7 29339980 ç || è7 p ç || è7 b ç 
 Benzidine and its salts || 92-87-5, 36341-27-2 and others || 202-199-1, 252-984-8 and others || 29215990 || i || sr 
   || — || — ||   ||   ||   
 Benzidine derivatives ||   ||   ||   ||   ||   
 è6 Butralin ç || è6 33629-47-9 ç || è6 251-607-4 ç || è6 29214900 ç || è6 p ç || è6 b ç 
 è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç 
 Carbaryl || 63-25-2 || 200-555-0 || 29242995 || p || b 
 è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç 
 è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç 
 Chlorfenapyr || 122453-73-0 ||   || 29339990 || p || sr 
 Chlozolinate || 84332-86-5 || 282-714-4 || 29349990 || p || b 
 è7 Diazinon ç || è7 333-41-5 ç || è7 206-373-8 ç || è7 29335910 ç || è7 p ç || è7 sr ç 
 è7 Dichlorvos ç || è7 62-73-7 ç || è7 200-547-7 ç || è7 29199000 ç || è7 p ç || è7 sr ç 
 è6 Dicofol ç || è6 115-32-2 ç || è6 204-082-0 ç || è6 29062900 ç || è6 p ç || è6 b ç 
 Dicofol containing < 78 % p, p'-Dicofol or 1 g/kg of DDT and DDT related compounds || 115-32-3 || 204-082-0 || 29062900 || p || b 
 Dimethenamid || 87674-68-8 || n.a. || 29349990 || p || b 
 è6 Diniconazole-M ç || è6 83657-18-5 ç || è6 n.a. ç || è6 29339980 ç || è6 p ç || è6 b ç 
 Dinoterb || 1420-07-1 || 215-813-8 || 29089990 || p || b 
 Endosulfan || 115-29-7 || 204-079-4 || 29209085 || p || b 
 è7 Fenarimol ç || è7 60168-88-9 ç || è7 262-095-7 ç || è7 29335995 ç || è7 p ç || è7 b ç 
 è7 Fenitrothion ç || è7 122-14-5 ç || è7 204-524-2 ç || è7 29201900 ç || è7 p ç || è7 sr ç 
 Fenthion || 55-38-9 || 200-231-9 || 29309085 || p || sr 
 Fentin acetate || 900-95-8 || 212-984-0 || 29310095 || p || b 
 Fentin hydroxide || 76-87-9 || 200-990-6 || 29310095 || p || b 
 è6 Flurprimidol ç || è6 56425-91-3 ç || è6 n.a. ç || è6 29335995 ç || è6 p ç || è6 b ç 
 è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç 
 è8 --- ç || è8 --- ç || è8 --- ç || è8 --- ç ||   ||   
 è7 Methamidophos[39] ç || è7 10265-92-6 ç || è7 233-606-0 ç || è7 29305000 ç || è7 p ç || è7 b ç 
 Methyl parathion # || 298-00-0 || 206-050-1 || 29201100 || p || b 
 Monomethyl-dibromo-diphenyl methane Tradename: DBBT || 99688-47-8 || 401-210-1 || 29036990 || i || b 
 Monomethyl-Dichloro-Diphenyl methane; Tradename: Ugilec 121 or Ugilec 21 || — || 400-140-6 || 29036990 || i || b 
 Monomethyl-Tetrachlorodiphenyl methane; Tradename: Ugilec 141 || 76253-60-6 || 278-404-3 || 29036990 || i || b 
 è6 Nicotine ç || è6 54-11-5 ç || è6 200-193-3 ç || è6 29399900 ç || è6 p ç || è6 b ç 
 Nitrofen || 1836-75-5 || 217-406-0 || 29093090 || p || b 
 Nonylphenols C6H4(OH)C9H19 || 25154-52-3 (phenol, nonyl-), || 246-672-0 || 29071300 || i || sr 
   || 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 ||   ||   ||   
 Nonylphenol ethoxylates (C2H4O)nC15H24O || 9016-45-9, 26027-38-3, 68412-54-4, 37205-87-1, 127087-87-0 and others ||   || 34021300 || i p || sr b 
 Octabromodiphenyl ether || 32536-52-0 || 251-087-9 || 29093038 || i || sr 
 Oxydemeton-methyl || 301-12-2 || 206-110-7 || 29309085 || p || b 
 è7 Paraquat ç || è7 1910-42-5 ç || è7 217-615-7 ç || è7 29333999 ç || è7 p ç || è7 b ç 
 Pentabromodiphenyl ether || 32534-81-9 || 251-084-2 || 29093031 || i || sr 
 Perfluorooctane sulfonates || 1763-23-1 || n.a. || 29049020 || i || sr 
 (PFOS) C8F17SO2X (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers) || 2795-39-3 and others ||   || 29049020 and others ||   ||   
 Phosalone || 2310-17-0 || 218-996-2 || 29349990 || p || b 
 è7 Procymidone ç || è7 32809-16-8 ç || è7 251-233-1 ç || è7 29251995 ç || è7 p ç || è7 b ç 
 è6 Propachlor ç || è6 1918-16-7 ç || è6 217-638-2 ç || è6 29242998 ç || è6 p ç || è6 b ç 
 Pyrazophos || 13457-18-6 || 236-656-1 || 29335995 || p || b 
 Quintozene || 82-68-8 || 201-435-0 || 29049085 || p || b 
 è5 Simazine ç || è5 122-34-9 ç || è5 204-535-2 ç || è5 29336910 ç || è5 p ç || è5 b ç 
 Tecnazene || 117-18-0 || 204-178-2 || 29049085 || p || b 
 Thiodicarb || 59669-26-0 || 261-848-7 || 29309085 || p || b 
 è7 Tolylfluanid ç || è7 731-27-1 ç || è7 211-986-9 ç || è7 29309085 ç || è7 p ç || è7 sr ç 
 Trichlorfon || 52-68-6 || 200-149-3 || 29310095 || p || b 
 è5 Triorganostannic compounds other than tributyltin compounds ç || è5 — ç || è5 — ç || è5 29310095 and others ç || è5 p ç || è5 sr ç 
 è7 Vinclozolin ç || è7 50471-44-8 ç || è7 256-599-6 ç || è7 29349990 ç || è7 p ç || è7 b ç 
(*)           Category: p – pesticides; i –
industrial chemical.
(**)        Use limitation: sr – severe
restriction, b – ban (for the category or categories concerned).
CAS No = Chemical Abstracts Service
Registry Number.
#             Chemical subject or partially
subject to the international PIC procedure.
            
PART 3
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 || 93-76-5 # || 2918.91 || 3808.50 || Pesticide 
 Aldrin (*) || 309-00-2 || 2903.52 || 3808.50 || Pesticide 
 Binapacryl || 485-31-4 || 2916.19 || 3808.50 || Pesticide 
 Captafol || 2425-06-1 || 2930.50 || 3808.50 || Pesticide 
 Chlordane (*) || 57-74-9 || 2903.52 || 3808.50 || Pesticide 
 Chlordimeform || 6164-98-3 || 2925.21 || 3808.50 || Pesticide 
 Chlorobenzilate || 510-15-6 || 2918.18 || 3808.50 || Pesticide 
 DDT (*) || 50-29-3 || 2903.62 || 3808.50 || Pesticide 
 Dieldrin (*) || 60-57-1 || 2910.40 || 3808.50 || Pesticide 
 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 || 3808.91 3808.92 3808.93 || Pesticide 
 Dinoseb and its salts and esters || 88-85-7 # || 2908.91 || 3808.50 || Pesticide 
 1,2-dibromoethane (EDB) || 106-93-4 || 2903.31 || 3808.50 || Pesticide 
 Ethylene dichloride (1,2-dichloroethane) || 107-06-2 || 2903.15 || 3808.50 || Pesticide 
 Ethylene oxide || 75-21-8 || 2910.10 || 3808.50 3824.81 || Pesticide 
 Fluoroacetamide || 640-19-7 || 2924.12 || 3808.50 || Pesticide 
 HCH (mixed isomers) || 608-73-1 || 2903.51 || 3808.50 || Pesticide 
 Heptachlor (*) || 76-44-8 || 2903.52 || 3808.50 || Pesticide 
 Hexachlorobenzene (*) || 118-74-1 || 2903.62 || 3808.50 || Pesticide 
 Lindane || 58-89-9 || 2903.51 || 3808.50 || Pesticide 
 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/ || 2852.00 || 3808.50 || Pesticide 
 Monocrotophos || 6923-22-4 || 2924.12 || 3808.50 || Pesticide 
 Parathion || 56-38-2 || 2920.11 || 3808.50 || Pesticide 
 Pentachlorophenol and its salts and esters || 87-86-5 # || 2908.11 2908.19 || 3808.50 3808.91 3808.92 3808.93 3808.94 3808.99 || Pesticide 
 Toxaphene (*) || 8001-35-2 || — || 3808.50 || Pesticide 
 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 || — || 3808.92 || Severely hazardous pesticide formulation 
 Methamidophos (soluble liquid formulations of the substance that exceed 600 g active ingredient/l) || 10265-92-6 || 2930.50 || 3808.50 || Severely hazardous pesticide formulation 
 Methyl-parathion (emulsifiable concentrates (EC) at or above 19,5 % active ingredient and dusts at or above 1,5 % active ingredient) || 298-00-0 || 2920.11 || 3808.50 || Severely hazardous pesticide formulation 
 Phosphamidon (soluble liquid formulations of the substance that exceed 1000 g active ingredient/l) ||   || 2924.12 || 3808.50 || Severely hazardous pesticide formulation 
 Mixture (E) & (Z) isomers || 13171-21-6 ||   ||   ||   
 (Z)-isomer || 23783-98-4 ||   ||   ||   
 (E)-isomer || 297-99-4 ||   ||   ||   
 Asbestos fibres: ||   || 2524.10 2524.90 || 6811.40 6812.80 6812.91 6812.92 6812.93 6812.99 6813.20 || Industrial 
 Crocidolite || 12001-28-4 || 2524.10 ||   ||   
 Actinolite || 77536-66-4 || 2524.90 ||   ||   
 Anthophyllite || 77536-67-5 || 2524.90 ||   ||   
 Amosite || 12172-73-5 || 2524.90 ||   ||   
 Tremolite || 77536-68-6 || 2524.90 ||   ||   
 Polybrominated biphenyls (PBB) ||   ||   ||   ||   
 –               (hexa-) || 36355-01-8 || — || 3824.82 ||   
   ||   ||   ||   || Industrial 
 –               (octa-) || 27858-07-7 ||   ||   ||   
 –               (deca-) || 13654-09-6 ||   ||   ||   
 Polychlorinated biphenyls (PCB) (*) || 1336-36-3 || — || 3824.82 || Industrial 
 Polychlorinated terphenyls (PCT) || 61788-33-8 || — || 3824.82 || Industrial 
 Tetraethyl lead || 78-00-2 || 2931.00 || 3811.11 || Industrial 
 Tetramethyl lead || 75-74-1 || 2931.00 || 3811.11 || Industrial 
 è9 All tributyltin compounds, including: ç ||   || è9 2931.00 ç || è9 3808.99 ç || è9 Pesticide ç 
 è9 Tributyltin oxide ç || è9 56-35-9 ç || è9 2931.00 ç || è9 3808.99 ç 
 è9 Tributyltin fluoride ç || è9 1983-10-4 ç || è9 2931.00 ç || è9 3808.99 ç 
 è9 Tributyltin methacrylate ç || è9 2155-70-6 ç || è9 2931.00 ç || è9 3808.99 ç 
 è9 Tributyltin benzoate ç || è9 4342-36-3 ç || è9 2931.00 ç || è9 3808.99 ç 
 è9 Tributyltin chloride ç || è9 1461-22-9 ç || è9 2931.00 ç || è9 3808.99 ç 
 è9 Tributyltin linoleate ç || è9 24124-25-2 ç || è9 2931.00 ç || è9 3808.99 ç 
 è9 Tributyltin naphthenate ç || è9 85409-17-2 ç || è9 2931.00 ç || è9 3808.99 ç 
 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.
ê 689/2008
Annex II (adapted)
ANNEX II
EXPORT NOTIFICATION
Ö The following
information is Õ 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 Ö mixture Õ preparation
to be exported:
(a)     trade name and/or designation of the Ö mixture Õ 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;
(e)     intended use in the country of
destination, if known, including information on the category(ies) under the
Rotterdam Convention under which the use falls;
(f)      name, address and other relevant
particulars of the importer or importing company;
(g)     name, address and other relevant
particulars of the exporter or exporting company.
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.
6.                      
Information on precautions to be taken,
including category of danger and risk and safety advice.
7.                      
A summary on physicochemical, toxicological and
ecotoxicological properties.
8.                      
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.
9.                      
Information on precautionary measures to reduce
exposure to, and emission of, the chemical.
10.                  
Summary of regulatory restrictions and reasons
for them.
11.                  
Summary of information given in Annex IV
under point 2(a), (c) and (d).
12.                  
Additional information provided by the exporting
Party because considered of concern or further information specified in
Annex IV when requested by the importing Party.
ê 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, Ö mixtures Õ 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, Ö mixtures Õ preparations
and articles) as outlined below.
 Chemical || Importing country || Quantity of substance 
   ||   ||   
   ||   ||   
   ||   ||   
            
2.                      
List of importers
 Chemical || Importing country || Importer or importing company || Address and other relevant particulars of the importer or the importing company 
   ||   ||   ||   
   ||   ||   ||   
   ||   ||   ||   
ê 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 Ö mixtures Õ preparations;
(d)     code numbers: Chemical Abstracts
Service (CAS) number, Harmonised System Customs Code and other numbers;
(e)     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;
(vi)     summary of the hazards and risks
presented by the chemical to human health, including the health of consumers
and workers, or the environment and the expected effect of the final regulatory
action;
(b)     category or categories where the final
regulatory action has been taken, and for each category:
(i)      use or uses prohibited by the final
regulatory action;
(ii)      use or uses that remain allowed;
(iii)     estimation, where available, of
quantities of the chemical produced, imported, exported and used;
(c)     an indication, to the extent possible,
of the likely relevance of the final regulatory action to other States and
regions;
(d)     other relevant information that may
cover:
(i)      assessment of 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.
ê 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 || EC No 206-215-8, CAS No 309-00-2, CN code 29035200 
   || Chlordane || EC No 200-349-0, CAS No 57-74-9, CN code 29035200 
   || Dieldrin || EC No 200-484-5, CAS No 60-57-1, CN code 29104000 
   || DDT (1,1,1-trichloro-2,2-bis (p-chlorophenyl) ethane || EC No 200-024-3, CAS No 50-29-3, CN code 29036200 
   || Endrin || EC No 200-775-7, CAS No 72-20-8, CN code 29109000 
   || Heptachlor || EC No 200-962-3, CAS No 76-44-8, CN code 29035200 
   || Hexachlorobenzene || EC No 200-273-9, CAS No 118-74-1, CN code 29036200 
   || Mirex || EC No 219-196-6, CAS No 2385-85-5, CN code 29035980 
   || Toxaphene (camphechlor) || EC No 232-283-3, CAS No 8001-35-2, CN code 38085000 
   || Polychlorinated biphenyls (PCBs) || 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 
ê 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 
   ||   
   ||   
APPENDIX 1
CORRELATION TABLE
 This Regulation || Regulation (EC) No 689/2008 
 Article 1 1.1 1.2 ||   Article 1.1 Article 1.2 
 Article 2 2.1 2.2 2.3 ||   Article 2.1 Article 2.2 
 Article 3 || Article 3 
 Article 4 || Article 4 
 Article 5 5.1 5.2 ||   Article 5.2 Article 5.3 
 Article 6 6.1 6.2 ||   
 Article 7 7.1 7.2 7.3 ||   Article 6.1 Article 6.2 Article 6.3 
 Article 8 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 ||   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 9 9.1 9.2 ||   Article 8.1 Article 8.2 
 Article 10 10.1 10.2 10.3 ||   Article 9.1 Article 9.2 Article 9.3 
 Article 11 11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8 ||   Article 10.1 Article 10.2 Article 10.3 Article 10.4 Article 10.5 Article 10.6 Article 10.7 Article 10.8 
 Article 12 || Article 11 
 Article 13 13.1 13.2 13.3 13.4 13.5 13.6 ||   Article 12.1 Article 12.2 Article 12.3 Article 12.4 Article 12.5 Article 12.6 
 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 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 15 15.1 15.2 ||   Article 14.1 Article 14.2 
 Article 16 16.1 16.2 16.3 16.4 ||   Article 15.1 Article 15.2 Article 15.3 Article 15.4 
 Article 17 17.1 17.2 17.3 17.4 ||   Article 16.1 Article 16.2 Article 16.3 Article 16.4 
 Article 18 18.1 18.2 18.3 ||   Article 17.1   Article 17.1 
 Article 19 19.1 19.2 19.3 19.4 ||   Article 17.2 
 Article 20 20.1 20.2 20.3 ||   Article 19.1 Article 19.2 Article 19.3 
 Article 21 || Article 20 
 Article 22 22.1 22.2 22.3 ||   Article 21.1 Article 21.2 Article 21.3 
 Article 23 23.1 23.2 23.3 23.4 ||   Article 22.1 Article 22.2 Article 22.3 Article 22.4 
 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 24.1 Article 24.2 
 Article 30 ||   
 Article 31 || Article 18 
 Article 32 || Article 25 
 Article 33 || Article 26 
 Annex I || Annex I 
 Annex II || Annex II 
 Annex III || Annex III 
 Annex IV || Annex IV 
 Annex V || Annex V 
 Annex VI || Annex VI 
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
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
structure[40] 

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

1.3.                
Nature of the proposal/initiative 

¨ The
proposal/initiative relates to a new action 
¨ The
proposal/initiative relates to a new action following a pilot
project/preparatory action[41]

x The proposal/initiative relates to the
extension of an existing action 
¨ 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
         Activity Code 07 03 : Implementation of Union environmental
policy and legislation

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:
(1)     the implementation of the Globally Harmonised System (GHS)
of classification and labelling into Union legislation through the adoption of
Regulation (EC) No 1272/2008;
(2)     the establishment of the European Chemicals Agency ("the
Agency") under Regulation (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:
(1)     an increase in access to and understanding of information,
in particular for developing 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;
(3)     some proposed amendments will lead to a reduction of
administrative burdens regarding 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;
- 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.
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).

1.6.                
Duration and financial impact 

¨ Proposal/initiative of limited
duration 
–     
¨ Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY 
–     
¨ Financial impact from YYYY to YYYY 
x 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) envisaged[42] 

xCentralised direct management by the
Commission 
xCentralised indirect management with the
delegation of implementation tasks to:
–     
¨ executive agencies 
–     
x            bodies set up by the Communities[43] 
–     
¨ national public-sector bodies/bodies with public-service mission 
–     
¨ 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

¨ Shared management with the Member States 
¨ Decentralised management with third countries 
¨ Joint management with international organisations (to be specified)
If more than one
management mode is indicated, please provide details in the
"Comments" section.
Comments 
            

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.

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.

3.                      
ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE
3.1.                
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.
 Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution 
 Number [Description………………………...……….] || DA/NDA ([44]) || from EFTA[45] countries || from candidate countries[46] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation 
   || [XX.YY.YY.YY]   || DA/NDA || YES/NO || YES/NO || YES/NO || YES/NO 
·      New budget lines requested 
In order of multiannual financial framework
headings and budget lines.
 Heading of multiannual financial framework || 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 
 2 || 07. 03 70 01 Chemicals Agency – Activities in the Field of Legislation on PIC – subsidy under Titles 1&2 || Diff || YES || NO || NO || NO 
 2 || 07. 03 70 02 Chemicals Agency – Activities in the Field of Legislation on PIC– subsidy under Title 3 || Diff || YES || NO || NO || NO 

3.2.                
Estimated impact on expenditure 
3.2.1.          
Summary of estimated impact on expenditure 

EUR million (to 3 decimal places)
 Heading of multiannual financial framework: || Number || 2. Preservation and Management of Natural Resources 
 DG: Environment ||   ||   || 2012 || 2013 || 2014 || 2015 || 2016[47] || TOTAL 
  Operational appropriations ||   ||   ||   ||   ||   ||   
 07.03.70.01 || Commitments || (1) || 0,349 || 0,620 || 0,718 || 0,744 || 0,772 ||   
 Payments || (2) || 0,349 || 0,620 || 0,718 || 0,744 || 0,772 ||   
 07.03.70.02 || Commitments || (1a) || 1,122 || 1,012 || 0,563 || 0,463 || 0,363 ||   
 Payments || (2a) || 1,122 || 1,012 || 0,563 || 0,463 || 0,363 ||   
 Appropriations of an administrative nature financed  from the envelop of specific programs[48] ||   ||   ||   ||   ||   ||   
 Number of budget line ||   || (3) ||   ||   ||   ||   ||   ||   
 TOTAL appropriations for DG Environment || Commitments || =1+1a +3 || 1,470 || 1,632 || 1,281 || 1,207 || 1,135 ||   
 Payments || =2+2a +3 || 1,470 || 1,632 || 1,281 || 1,207 || 1,135 ||   
  TOTAL operational appropriations || Commitments || (4) || 1,470 || 1,632 || 1,281 || 1,207 || 1,135 ||   
 Payments || (5) || 1,470 || 1,632 || 1,281 || 1,207 || 1,135 ||   
  TOTAL appropriations of an administrative nature financed from the envelop of specific programs || (6) ||   ||   ||   ||   ||   ||   
 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:
  TOTAL operational appropriations || Commitments || (4) ||   ||   ||   ||   ||   ||   
 Payments || (5) ||   ||   ||   ||   ||   ||   
  TOTAL appropriations of an administrative nature financed from the envelop of specific programs || (6) ||   ||   ||   ||   ||   ||   
 TOTAL appropriations under HEADINGS 1 to 4 of the multiannual financial framework (Reference amount) || Commitments || =4+ 6 ||   ||   ||   ||   ||   ||   
 Payments || =5+ 6 ||   ||   ||   ||   ||   ||   
 Heading of multiannual financial framework: || 5 || " Administrative expenditure " 
EUR million (to 3 decimal places)
   ||   ||   || 2012 || 2013 || 2014 || 2015 || TOTAL 
 DG: Environment || 
  Human resources || 0,191 || 0,191 || 0,191 || 0,191 ||   
  Other administrative expenditure || 0,025 || 0,025 || 0,025 || 0,025 ||   
 TOTAL DG Environment || Appropriations || 0,216 || 0,216 || 0,216 || 0,216 ||   
 DG: JRC || 
  Human resources || 0,058 || 0,039 ||   ||   ||   
  Other administrative expenditure || 0,088 || 0,059 ||   ||   ||   
 TOTAL DG JRC || Appropriations || 0,146 || 0,098 ||   ||   ||   
 TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || 0,362 || 0,314 || 0,216 || 0,216 ||   ||   ||   ||   
EUR million (to 3 decimal places)
   ||   ||   ||   ||   ||   ||   || TOTAL 
 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 ||   

3.2.2.          
Estimated impact on operational appropriations 

–     
¨ The proposal/initiative does not require the use of operational
appropriations 
–     
x            The proposal/initiative requires the use of operational
appropriations, as explained below:
Commitment appropriations in EUR million (to 3 decimal
places)
 Indicate objectives and outputs   ò ||   ||   || 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 
 OUTPUTS 
 Type of output[49] || Average cost of the output || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Total number of outputs || Total cost 
 SPECIFIC OBJECTIVE No 1[50]… ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 - IT system ||   ||   || 1 || 1,000 || 1 || 0,800 || 1 || 0,350 || 1 || 0,250 ||   ||   ||   ||   ||   ||   ||   ||   
 - Export notifications ||   ||   ||   || 0,406 || 2000 || 0,768 || 5300 || 0,867 || 5800 || 0,893 ||   ||   ||   ||   ||   ||   ||   ||   
 - DGDs + PIC notifications ||   ||   ||   || 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 ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 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.

3.2.3.          
Estimated impact on appropriations of an
administrative nature
3.2.3.1.    
Summary 

–     
¨ The proposal/initiative does not require the use of administrative
appropriations 
–     
x            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 ||   ||   ||   ||   
 Other administrative expenditure || 0,025 || 0,025 || 0,025 || 0,025 ||   ||   ||   ||   
 Subtotal DG ENV HEADING 5 of the multiannual financial framework || 0,216 || 0,216 || 0,216 || 0,216 ||   ||   ||   ||   
 DG JRC HEADING 5[52] of the multiannual financial framework ||   ||   ||   ||   ||   ||   ||   ||   
 Human resources || 0,058 || 0,039 ||   ||   ||   ||   ||   ||   
 Other expenditure of an administrative nature || 0,088 || 0,059 ||   ||   ||   ||   ||   ||   
 Subtotal DG JRC HEADING 5 of the multiannual financial framework || 0,146 || 0,098 ||   ||   ||   ||   ||   ||   
 TOTAL || 0,362 || 0,314 || 0,216 || 0,216 ||   ||   ||   ||   
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.

3.2.3.2.    
 Estimated requirements of human resources 

–     
¨ The proposal/initiative does not require the use of human resources

–     
x            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) 
  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) ||   ||   ||   ||   ||   ||   ||   
 ||  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 Headquarters[55] ||   ||   ||   ||   ||   ||   ||   
 || - 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 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 || 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. 
 External personnel ||   

3.2.4.          
Compatibility with the current multiannual
financial framework 

–     
x            Proposal/initiative is compatible with the current
multiannual financial framework.
–     
¨ 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.
            
–     
¨ Proposal/initiative requires application of the flexibility
instrument or revision of the multiannual financial framework[56].
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 
 Specify the co-financing body ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL appropriations cofinanced ||   ||   ||   ||   ||   ||   ||   ||   

3.3.                
Estimated impact on revenue 

–     
x            Proposal/initiative has no financial impact on revenue.
–     
¨ Proposal/initiative has the following financial impact:
–                   
¨        on own resources 
–                   
¨        on miscellaneous revenue 
EUR million (to 3 decimal places)
 Budget revenue line: || Appropriations available for the ongoing budget exercise || Impact of the proposal/initiative[57] 
 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) 
 Article …………. ||   ||   ||   ||   ||   ||   ||   ||   
For miscellaneous
assigned revenue, specify the budget expenditure line(s) affected.
         
Specify the method for
calculating the impact on revenue.
         
ANNEX 1
Draft Budget for the European Chemicals Agency (in Euros)
Tasks
related to Prior Informed Consent
 Expenditure || 2012 || 2013 || 2014 || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || 2021 
 Title1 ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Salaries & allocations || 251.100 || 471.800 || 505.900 || 523.800 || 543.800 || 563.900 || 570.600 || 570.600 || 570.600 || 570.600 
 Other personnel costs || 33.600 || 45.600 || 67.800 || 70.200 || 72.900 || 75.600 || 76.500 || 76.500 || 76.500 || 76.500 
 Total Title 1 || 284.700 || 517.400 || 573.700 || 594.000 || 616.700 || 639.500 || 647.100 || 647.100 || 647.100 || 647.100 
   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Title 2 ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 20 Rental of building and associated costs* || 33.000 || 50.000 || 74.900 || 77.600 || 80.500 || 83.500 || 84.500 || 84.500 || 84.500 || 84.500 
 21 Information & communication technology** || 21.100 || 33.700 || 49.700 || 51.400 || 53.400 || 55.400 || 56.000 || 56.000 || 56.000 || 56.000 
 22 Movable property and associated costs** || 5.100 || 8.800 || 10.400 || 10.700 || 11.100 || 11.600 || 11.700 || 11.700 || 11.700 || 11.700 
 23 Current administrative expenditure* || 4.700 || 9.900 || 9.500 || 9.800 || 10.200 || 10.500 || 10.700 || 10.700 || 10.700 || 10.700 
 25 Meetings expenditure* || 100 || 200 || 200 || 200 || 200 || 200 || 200 || 200 || 200 || 200 
 Total Title 2 || 64.000 || 102.600 || 144.700 || 149.700 || 155.400 || 161.200 || 163.100 || 163.100 || 163.100 || 163.100 
   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Title 3 ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Development of databases and software tools related to the operation of PIC || 1.000.000 || 800.000 || 350.000 || 250.000 || 150.000 || 150.000 || 100.000 || 100.000 || 100.000 || 100.000 
 Information and publications || 10.000 || 10.000 || 10.000 || 10.000 || 10.000 || 10.000 || 10.000 || 10.000 || 10.000 || 10.000 
 Helpdesk services/Guidance || 0 || 20.000 || 20.000 || 20.000 || 20.000 || 20.000 || 20.000 || 20.000 || 20.000 || 20.000 
 Studies and Consultants || 100.000 || 100.000 || 100.000 || 100.000 || 100.000 || 100.000 || 100.000 || 100.000 || 100.000 || 100.000 
 Mission expenses || 5.000 || 10.000 || 10.000 || 10.000 || 10.000 || 10.000 || 10.000 || 10.000 || 10.000 || 10.000 
 Technical training of staff and stakeholders || 900 || 2.000 || 2.700 || 2.700 || 2.800 || 3.000 || 3.000 || 3.000 || 3.000 || 3.000 
 Meetings of the DNAs and expert groups on PIC implementation || 5.700 || 70.000 || 70.200 || 70.200 || 70.200 || 70.200 || 70.200 || 70.200 || 70.200 || 70.200 
 Total Title 3 || 1.121.600 || 1012.000 || 562.900 || 462.900 || 363.000 || 363.200 || 313.200 || 313.200 || 313.200 || 313.200 
   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 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 
 Revenues ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Union subvention || 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 
 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 
            
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 || Salary 
 AD 13 || 243,156 
 AD 12 || 195,900 
 AD 5-11 || 120,288 
 AST 7-8 || 104,778 
 AST 1-6 || 66,872 
            
Applied average
costs for contract agents by function group per annum (source the Agency)
 Grade || Salary 
 FG IV || 55,869 
 FG III || 55,287 
 FG II || 37,319 
 FG I || 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.
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 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 
 AD 12 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 
 AD 5-11 || 1 || 1 || 1 || 1 || 1 || 1 || 1 || 1 || 1 || 1 
 AST 7-11 || 1 || 3 || 2 || 2 || 2 || 2 || 2 || 2 || 2 || 2 
 AST 1-6 || 1 || 1 || 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 
            
[1]               OJ L 204, 31.7.2008, p. 1
[2]               OJ L 353, 31. 12. 2008, p. 1
[3]               OJ L 60, 10.3.2010, p. 5
[4]               ECR (2006), I-107.
[5]               OJ C 175,
27.7.2007, p. 40.
[6]               Opinion of the
European Parliament of 15 January 2008 (not yet published in the Official
Journal) and Council Decision of 5 June 2008.
[7]               OJ L 204, 31.7.2008, p. 1. 
[8]               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).
[9]               OJ L 63, 6.3.2003, p. 29.
[10]             OJ L 63, 6.3.2003, p. 1 
[11]             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).
[12]             ECR [2006], I-107.
[13]             OJ L 396, 30.12.2006, p. 1.
[14]             OJ L 353, 31. 12. 2008, p. 1.
[15]             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).
[16]             OJ
L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC
(OJ L 200, 22.7.2006, p. 11).
[17]             OJ L 55, 28.2.2011, p. 13.
[18]             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.
[19]             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.
[20]             OJ L 22, 26.1.2005,
p. 1.
[21]             OJ L 159, 29.6.1996,
p. 1.
[22]             OJ L 114, 27.4.2006,
p. 9.
[23]             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).
[24]             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).
[25]             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).
[26]             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).
[27]             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).
[28]             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).
[29]             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).
[30]             OJ L 309, 24.11.2009,
p. 1.
[31]             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).
[32]             OJ L 302, 19.10.1992, p. 1
[33]             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).
[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).
[35]             OJ L 41, 14.2.2003,
p. 26.
[36]             OJ L 158, 30.4.2004, p. 7.
[37]             This entry does not affect the
existing entry for cis-1,3-dichloropropene (CAS No 10061-01-5).
[38]             This entry does not affect the
existing entry for soluble liquid formulations of methamidophos that exceed
600 g active ingredient/l.
[39]             è7 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. ç
[40]             ABM: Activity-Based Management – ABB: Activity-Based
Budgeting.
[41]             As referred to in Article 49(6)(a) or (b) of the
Financial Regulation.
[42]             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
[43]             As referred to in Article 185 of the Financial
Regulation.
[44]             DA= Differentiated appropriations / DNDA=
Non-Differentiated Appropriations
[45]             EFTA: European Free Trade Association. 
[46]             Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.
[47]             The yearly budget remains unchanged from 2018 onwards
[48]             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.
[49]             Outputs are products and services to be supplied (e.g.:
number of student exchanges financed, number of km of roads built, etc.).
[50]             As described in Section 1.4.2. "Specific
objective(s)…"
[51]             Year N is the year in which implementation of the
proposal/initiative starts.
[52]             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.
[53]             CA= Contract Agent; INT= agency staff ("Intérimaire");
JED= "Jeune Expert en Délégation" (Young Experts in
Delegations); LA= Local Agent; SNE= Seconded National Expert; 
[54]             Under
the ceiling for external personnel from operational
appropriations (former "BA" lines).
[55]             Essentially for Structural Funds, European Agricultural
Fund for Rural Development (EAFRD) and European Fisheries Fund (EFF).
[56]             See points 19 and 24 of the Interinstitutional
Agreement.
[57]             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.