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Official Journal of the European Union

EN

29.5.2007

TABLE OF CONTENTS
Page

TITLE I

GENERAL ISSUES

18

Chapter 1

Aim, scope and application

18

Chapter 2

Definitions and general provision

19

TITLE IIREGISTRATION OF SUBSTANCES

22

Chapter 1

General obligation to register and information requirements

22

Chapter 2

Substances regarded as being registered

27

Chapter 3

Obligation to register and information requirements for certain types of isolated intermediates

28

Chapter 4

Common provisions for all registrations

29

Chapter 5

Transitional provisions applicable to phase-in substances and notified substances

31

TITLE IIIDATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING

32

Chapter 1

Objectives and general rules

32

Chapter 2

Rules for non-phase-in substances and registrants of phase-in substances who have not preregistered

32

Chapter 3

Rules for phase-in-substances

33

TITLE IVINFORMATION IN THE SUPPLY CHAIN

35

TITLE VDOWNSTREAM USERS

37

TITLE VIEVALUATION

39

Chapter 1

Dossier evaluation

39

Chapter 2

Substance evaluation

40

Chapter 3

Evaluation of intermediates

42

Chapter 4

Common provisions

42

TITLE VIIAUTHORISATION

44

Chapter 1

Authorisation requirement

44

Chapter 2

Granting of authorisations

46

Chapter 3

Authorisations in the supply chain

50

TITLE VIII

RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF
CERTAIN DANGEROUS SUBSTANCES AND PREPARATIONS

50

Chapter 1

General issues

50

Chapter 2

Restrictions process

50

TITLE IX

FEES AND CHARGES

52

TITLE XAGENCY53

TITLE XI

CLASSIFICATION AND LABELLING INVENTORY

63

TITLE XIIINFORMATION64

TITLE XIIICOMPETENT AUTHORITIES66

TITLE XIV

ENFORCEMENT

66

TITLE XVTRANSITIONAL AND FINAL PROVISIONS

66

ANNEX I

GENERAL PROVISIONS FORCHEMICAL SAFETY REPORTS

ASSESSING

SUBSTANCES AND

PREPARING
72

ANNEX IIGUIDE TO THE COMPILATION OF SAFETY DATA SHEETS

84

ANNEX III

CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10TONNES

93

EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH
ARTICLE 2(7)(a)94

EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH
ARTICLE 2(7)(b)98

ANNEX IVANNEX V

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Page

ANNEX VI

INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10

99

ANNEX VII

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE

103

ANNEX VIIISTANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE

107

ANNEX IXSTANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE

111

ANNEX XSTANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE

116

GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SETOUT IN ANNEXES VII TO X

119

ANNEX XII

GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCESAND PREPARE CHEMICAL SAFETY REPORTS

122

ANNEX XIII

CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE ANDTOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVESUBSTANCES

124

ANNEX XI

ANNEX XIVLIST OF SUBSTANCES SUBJECT TO AUTHORISATION

125

ANNEX XVDOSSIERS

126

ANNEX XVISOCIO-ECONOMIC ANALYSIS

128

ANNEX XVIIRESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE
OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES129

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Official Journal of the European UnionEN
TITLE I
GENERAL ISSUES

29.5.2007

3. Member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a
preparation or in an article, where necessary in the interests ofdefence.

CHAPTER 1

Aim, scope and application
4.

This Regulation shall apply without prejudice to:Article 1
Aim and scope
1.
The purpose of this Regulation is to ensure a high level ofprotection of human health and the environment, including thepromotion of alternative methods for assessment of hazards ofsubstances, as well as the free circulation of substances on theinternal market while enhancing competitiveness and innovation.
2.
This Regulation lays down provisions on substances andpreparations within the meaning of Article 3. These provisions
shall apply to the manufacture, placing on the market or use ofsuch substances on their own, in preparations or in articles andto the placing on the market of preparations.
3.
This Regulation is based on the principle that it is for
manufacturers, importers and downstream users to ensure thatthey manufacture, place on the market or use such substancesthat do not adversely affect human health or the environment.
Its provisions are underpinned by the precautionary principle.

Article 2
Application
1.

This Regulation shall not apply to:(a) radioactive substances within the scope of Council Directive 96/29/Euratom 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 fromionising radiation (1);(b) substances, on their own, in a preparation or in an article,
which are subject to customs supervision, provided that they
do not undergo any treatment or processing, and which are
in temporary storage, or in a free zone or free warehousewith a view to re-exportation, or in transit;(a) Community workplace and environmental legislation,
including Council Directive 89/391/EEC of 12 June 1989
on the introduction of measures to encourage improvementsin the safety and health of workers at work (3), Council
Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (4); Directive 98/24/
EC, Directive 2000/60/EC of the European Parliament andof the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (5)and Directive 2004/37/EC;(b) Directive 76/768/EEC as regards testing involving vertebrate
animals within the scope of that Directive.

5. The provisions of Titles II, V, VI and VII shall not apply tothe extent that a substance is used:(a) in medicinal products for human or veterinary use within
the scope of Regulation (EC) No 726/2004, Directive 2001/
82/EC of the European Parliament and of the Council of
6 November 2001 on the Community code relating toveterinary medicinal products (6) and Directive 2001/83/ECof the European Parliament and of the Council of
6 November 2001 on the Community code relating to
medicinal products for human use (7);(b) in food or feedingstuffs in accordance with Regulation (EC)No 178/2002 including use:(i) as a food additive in foodstuffs within the scope ofCouncil Directive 89/107/EEC of 21 December 1988
on the approximation of the laws of the Member Statesconcerning food additives authorised for use in foodstuffs intended for human consumption (8);(c) non-isolated intermediates;(d) the carriage of dangerous substances and dangerous
substances in dangerous preparations by rail, road, inland
waterway, sea or air.
2.
Waste as defined in Directive 2006/12/EC of the European
Parliament and of the Council (2) is not a substance, preparationor article within the meaning of Article 3 of this Regulation.
(1) OJ L 159, 29.6.1996, p. 1.
(2) OJ L 114, 27.4.2006, p. 9.

(3) OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC)No 1882/2003.
(4) OJ L 257, 10.10.1996, p. 26. 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).
(5) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision
No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).
(6) 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).
(7) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation(EC) No 1901/2006.
(8) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC)No 1882/2003.

29.5.2007

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Official Journal of the European Union(ii) as a flavouring in foodstuffs within the scope ofCouncil Directive 88/388/EEC of 22 June 1988 on theapproximation of the laws of the Member States
relating to flavourings for use in foodstuffs and tosource materials for their production (1) and Commission Decision 1999/217/EC of 23 February 1999
adopting a register of flavouring substances used in or
on foodstuffs drawn up in application of Regulation(EC) No 2232/96 of the European Parliament and of
the Council (2);exemption from these Titles does not prejudice the objectives of this Regulation;(c) substances on their own or in preparations, registered inaccordance with Title II, exported from the Community byan actor in the supply chain and re-imported into the Community by the same or another actor in the same supply
chain who shows that:(i) the substance being re-imported is the same as theexported substance;(iii) as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003 of the European Parliamentand of the Council of 22 September 2003 on additives
for use in animal nutrition (3);(iv) in animal nutrition within the scope of Council Directive 82/471/EEC of 30 June 1982 concerning certain
products used in animal nutrition (4).
6.
The provisions of Title IV shall not apply to the following
preparations in the finished state, intended for the final user:(ii) he has been provided with the information in accordance with Articles 31 or 32 relating to the exported
substance;(d) substances, on their own, in preparations or in articles,
which have been registered in accordance with Title II andwhich are recovered in the Community if:(i) the substance that results from the recovery process isthe same as the substance that has been registered inaccordance with Title II; and(a) medicinal products for human or veterinary use, within thescope of Regulation (EC) No 726/2004 and Directive
2001/82/EC and as defined in Directive 2001/83/EC;(ii) the information required by Articles 31 or 32 relating
to the substance that has been registered in accordancewith Title II is available to the establishment undertaking
the recovery.

(b) cosmetic products as defined in Directive 76/768/EEC;(c) medical devices which are invasive or used in direct physicalcontact with the human body in so far as Community
measures lay down provisions for the classification andlabelling of dangerous substances and preparations which
ensure the same level of information provision and protection as Directive 1999/45/EC;(d) food or feedingstuffs in accordance with Regulation (EC)No 178/2002 including use:

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8. On-site isolated intermediates and transported isolated
intermediates shall be exempted from:(a) Chapter 1 of Title II, with the exception of Articles 8 and 9;and(b) Title VII.

(i) as a food additive in foodstuffs within the scope of
Directive 89/107/EEC;(ii) as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC;

9. The provisions of Titles II and VI shall not apply to polymers.
CHAPTER 2(iii) as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003;

Definitions and general provision(iv) in animal nutrition within the scope of Directive
82/471/EEC.
7.

The following shall be exempted from Titles II, V and VI:
Article 3(a) substances included in Annex IV, as sufficient information is
known about these substances that they are considered tocause minimum risk because of their intrinsic properties;(b) substances covered by Annex V, as registration is deemed
inappropriate or unnecessary for these substances and their(1) OJ L 184, 15.7.1988, p. 61. Directive as last amended by Regulation(EC) No 1882/2003.
(2) OJ L 84, 27.3.1999, p. 1. Decision as last amended by Decision
2006/253/EC (OJ L 91, 29.3.2006, p. 48).
(3) OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission
Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).
(4) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Commission
Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81).

Definitions
For the purposes of this Regulation:
1.

substance: means a chemical element and its compounds inthe natural state or obtained by any manufacturing process,including any additive necessary to preserve its stability andany impurity deriving from the process used, but excluding
any solvent which may be separated without affecting thestability of the substance or changing its composition;

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2.

preparation: means a mixture or solution composed of two
or more substances;3.

article: means an object which during production is given a
special shape, surface or design which determines its function to a greater degree than does its chemical composition;

4.

producer of an article: means any natural or legal person
who makes or assembles an article within the Community;5.

polymer: means a substance consisting of molecules characterised by the sequence of one or more types of monomer
units. Such molecules must be distributed over a range ofmolecular weights wherein differences in the molecularweight are primarily attributable to differences in thenumber of monomer units. A polymer comprises thefollowing:(a) a simple weight majority of molecules containing atleast three monomer units which are covalently boundto at least one other monomer unit or other reactant;(b) less than a simple weight majority of molecules of thesame molecular weight.
In the context of this definition a ‘monomer unit’ means
the reacted form of a monomer substance in a polymer;

6.

monomer: means a substance which is capable of forming
covalent bonds with a sequence of additional like or unlike
molecules under the conditions of the relevant polymerforming reaction used for the particular process;7.

registrant: means the manufacturer or the importer of a
substance or the producer or importer of an article submitting a registration for a substance;

8.

manufacturing: means production
substances in the natural state;9.

orextraction

29.5.2007

14. distributor: means any natural or legal person establishedwithin the Community, including a retailer, who only storesand places on the market a substance, on its own or in a
preparation, for third parties;
15. intermediate: means a substance that is manufactured forand consumed in or used for chemical processing in order
to be transformed into another substance (hereinafterreferred to as synthesis):(a) non-isolated intermediate: means an intermediate thatduring synthesis is not intentionally removed (except
for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction
vessel, its ancillary equipment, and any equipment
through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework fortransfer from one vessel to another for the purpose of
the next reaction step, but it excludes tanks or othervessels in which the substance(s) are stored after the
manufacture;(b) on-site isolated intermediate: means an intermediate notmeeting the criteria of a non-isolated intermediate andwhere the manufacture of the intermediate and thesynthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one ormore legal entities;(c) transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to othersites;
16. site: means a single location, in which, if there is more than
one manufacturer of (a) substance(s), certain infrastructureand facilities are shared;ofmanufacturer: means any natural or legal person establishedwithin the Community who manufactures a substancewithin the Community;

10. import: means the physical introduction into the customs
territory of the Community;
11. importer: means any natural or legal person establishedwithin the Community who is responsible for import;
12. placing on the market: means supplying or making available, whether in return for payment or free of charge, to athird party. Import shall be deemed to be placing on themarket;13. downstream user: means any natural or legal person established within the Community, other than the manufacturer
or the importer, who uses a substance, either on its own orin a preparation, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user;

17. actors in the supply chain: means all manufacturers and/or
importers and/or downstream users in a supply chain;
18. Agency: means the European Chemicals Agency as established by this Regulation;
19. competent authority: means the authority or authorities orbodies established by the Member States to carry out the
obligations arising from this Regulation;
20. phase-in substance: means a substance which meets at least
one of the following criteria:(a) it is listed in the European Inventory of Existing
Commercial Chemical Substances (EINECS);(b) it was manufactured in the Community, or in the countries acceding to the European Union on 1 January
1995 or on 1 May 2004, but not placed on the market
by the manufacturer or importer, at least once in the
15 years before the entry into force of this Regulation,
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Official Journal of the European Union(c) it was placed on the market in the Community, or in
the countries acceding to the European Union on
1 January 1995 or on 1 May 2004, before entry into
force of this Regulation by the manufacturer orimporter and was considered as having been notified inaccordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of apolymer as set out in this Regulation, provided the
manufacturer or importer has documentary evidence ofthis;
21. notified substance: means a substance for which a notification has been submitted and which could be placed on themarket in accordance with Directive 67/548/EEC;
22. product and process orientated research and development:
means any scientific development related to product development or the further development of a substance, on its
own, in preparations or in articles in the course of whichpilot plant or production trials are used to develop the
production process and/or to test the fields of applicationof the substance;
23. scientific research and development: means any scientificexperimentation, analysis or chemical research carried out
under controlled conditions in a volume less than one
tonne per year;
24. use: means any processing, formulation, consumption,
storage, keeping, treatment, filling into containers, transferfrom one container to another, mixing, production of anarticle or any other utilisation;
25. registrant's own use: means an industrial or professionaluse by the registrant;
26. identified use: means a use of a substance on its own or ina preparation, or a use of a preparation, that is intended byan actor in the supply chain, including his own use, or thatis made known to him in writing by an immediate downstream user;
27. full study report: means a complete and comprehensive
description of the activity performed to generate the information. This covers the complete scientific paper as
published in the literature describing the study performed
or the full report prepared by the test house describing thestudy performed;
28. robust study summary: means a detailed summary of theobjectives, methods, results and conclusions of a full study
report providing sufficient information to make an independent assessment of the study minimising the need toconsult the full study report;
29. study summary: means a summary of the objectives,
methods, results and conclusions of a full study reportproviding sufficient information to make an assessment of
the relevance of the study;
30. per year: means per calendar year, unless stated otherwise,for phase-in substances that have been imported or manu-

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factured for at least three consecutive years, quantities
per year shall be calculated on the basis of the average
production or import volumes for the three preceding
calendar years;
31. restriction: means any condition for or prohibition of the
manufacture, use or placing on the market;
32. supplier of a substance or a preparation: means any manufacturer, importer, downstream user or distributor placing
on the market a substance, on its own or in a preparation,
or a preparation;
33. supplier of an article: means any producer or importer ofan article, distributor or other actor in the supply chain
placing an article on the market;
34. recipient of a substance or a preparation: means a downstream user or a distributor being supplied with a substanceor a preparation;
35. recipient of an article: means an industrial or professionaluser, or a distributor, being supplied with an article but
does not include consumers;
36. SME: means small and medium-sized enterprises as definedin the Commission Recommendation of 6 May 2003
concerning the definition of micro, small and mediumsized enterprises (1);37. exposure scenario: means the set of conditions, including
operational conditions and risk management measures, that
describe how the substance is manufactured or used during
its life-cycle and how the manufacturer or importer
controls, or recommends downstream users to control,
exposures of humans and the environment. These exposure
scenarios may cover one specific process or use or several
processes or uses as appropriate;
38. use and exposure category: means an exposure scenario
covering a wide range of processes or uses, where theprocesses or uses are communicated, as a minimum, in
terms of the brief general description of use;
39. substances which occur in nature: means a naturally occurring substance as such, unprocessed or processed only bymanual, mechanical or gravitational means, by dissolution
in water, by flotation, by extraction with water, by steam
distillation or by heating solely to remove water, or whichis extracted from air by any means;
40. not chemically modified substance: means a substance
whose chemical structure remains unchanged, even if it has
undergone a chemical process or treatment, or a physicalmineralogical transformation, for instance to remove impurities;
41. alloy: means a metallic material, homogenous on a macroscopic scale, consisting of two or more elements so
combined that they cannot be readily separated by mechanical means.
(1) OJ L 124, 20.5.2003, p. 36.

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Article 4
General provision
Any manufacturer, importer, or where relevant downstream
user, may, whilst retaining full responsibility for complying withhis obligations under this Regulation, appoint a third party
representative for all proceedings under Article 11, Article 19,
Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In
these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall notnormally be disclosed by the Agency to other manufacturers,
importers, or, where relevant, downstream users.

29.5.2007(a) the polymer consists of 2 % weight by weight (w/w) ormore of such monomer substance(s) or other substance(s) in
the form of monomeric units and chemically boundsubstance(s);(b) the total quantity of such monomer substance(s) or othersubstance(s) makes up one tonne or more per year.
4. A submission for registration shall be accompanied by thefee required in accordance with Title IX.

Article 7

TITLE II

Registration and notification of substances in articles
REGISTRATION OF SUBSTANCESCHAPTER 1

General obligation to register and information requirements

Article 5
No data, no market
Subject to Articles 6, 7, 21 and 23, substances on their own, in
preparations or in articles shall not be manufactured in theCommunity or placed on the market unless they have beenregistered in accordance with the relevant provisions of thisTitle where this is required.

1. Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met:(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;(b) the substance is intended to be released under normal orreasonably foreseeable conditions of use.
A submission for registration shall be accompanied by the fee
required in accordance with Title IX.

2. Any producer or importer of articles shall notify the
Agency, in accordance with paragraph 4 of this Article, if asubstance meets the criteria in Article 57 and is identified inaccordance with Article 59(1), if both the following conditions
are met:Article 6(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

General obligation to register substances on their own orin preparations(b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).

1.
Save where this Regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in one
or more preparation(s), in quantities of one tonne or more per
year shall submit a registration to the Agency.

3. Paragraph 2 shall not apply where the producer orimporter can exclude exposure to humans or the environment
during normal or reasonably foreseeable conditions of use
including disposal. In such cases, the producer or importer shall
supply appropriate instructions to the recipient of the article.

2.
For monomers that are used as on-site isolated intermediates or transported isolated intermediates, Articles 17 and 18
shall not apply.

4.

3.
Any manufacturer or importer of a polymer shall submit aregistration to the Agency for the monomer substance(s) or any
other substance(s), that have not already been registered by anactor up the supply chain, if both the following conditions aremet:

The information to be notified shall include the following:(a) the identity and contact details of the producer or importeras specified in section 1 of Annex VI, with the exception of
their own use sites;(b) the registration number(s) referred to in Article 20(1), if
available;

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Official Journal of the European UnionEN(c) the identity of the substance as specified in sections 2.1 to
2.3.4 of Annex VI;(d) the classification of the substance(s) as specified in
sections 4.1 and 4.2 of Annex VI;(e) a brief description of the use(s) of the substance(s) in thearticle as specified in section 3.5 of Annex VI and of theuses of the article(s);L 136/23

information on the supply of the latest update of the safety data
sheet referred to in Article 31.
3. If a representative is appointed in accordance with paragraphs 1 and 2, the non-Community manufacturer shall informthe importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users
for the purposes of this Regulation.

(f) the tonnage range of the substance(s), such as 1 to
10 tonnes, 10 to 100 tonnes and so on.
5.
The Agency may take decisions requiring producers orimporters of articles to submit a registration, in accordance withthis Title, for any substance in those articles, if all the following
conditions are met:(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;(b) the Agency has grounds for suspecting that:(i) the substance is released from the articles, and(ii) the release of the substance from the articles presents arisk to human health or the environment;(c) the substance is not subject to paragraph 1.
A submission for registration shall be accompanied by the fee
required in accordance with Title IX.
6.
Paragraphs 1 to 5 shall not apply to substances that havealready been registered for that use.
7.
From 1 June 2011 paragraphs 2, 3 and 4 of this Article
shall apply six months after a substance is identified in accordance with Article 59(1).
8.
Any measures for the implementation of paragraphs 1 to
7 shall be adopted in accordance with the procedure referred toin Article 133(3).

Article 9
Exemption from the general obligation to register for
product and process orientated research and development(PPORD)
1. Articles 5, 6, 7, 17, 18 and 21 shall not apply for aperiod of five years to a substance manufactured in the Community or imported for the purposes of product and process
orientated research and development by a manufacturer orimporter or producer of articles, by himself or in cooperation
with listed customers and in a quantity which is limited to the
purpose of product and process orientated research and development.
2. For the purpose of paragraph 1, the manufacturer orimporter or producer of articles shall notify the Agency of thefollowing information:(a) the identity of the manufacturer or importer or producer ofarticles as specified in section 1 of Annex VI;(b) the identity of the substance, as specified in section 2 ofAnnex VI;(c) the classification of the substance as specified in section 4of Annex VI, if any;(d) the estimated quantity as specified in section 3.1 ofAnnex VI;

Article 8(e) the list of customers referred to in paragraph 1, including
their names and addresses.

Only representative of a non-Community manufacturer

The notification shall be accompanied by the fee required inaccordance with Title IX.

1.
A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces anarticle that is imported into the Community may by mutual
agreement appoint a natural or legal person established in theCommunity to fulfil, as his only representative, the obligations
on importers under this Title.
2.
The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shallhave a sufficient background in the practical handling of
substances and the information related to them and, without
prejudice to Article 36, shall keep available and up-to-date information on quantities imported and customers sold to, as well as

The period set out in paragraph 1 shall begin at receipt of thenotification at the Agency.
3. The Agency shall check the completeness of the information supplied by the notifier and Article 20(2) shall apply
adapted as necessary. The Agency shall assign a number to thenotification and a notification date, which shall be the date ofreceipt of the notification at the Agency, and shall forthwith
communicate that number and date to the manufacturer, or
importer, or producer of articles concerned. The Agency shallalso communicate this information to the competent authorityof the Member State(s) concerned.

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4.
The Agency may decide to impose conditions with theaim of ensuring that the substance or the preparation or article
in which the substance is incorporated will be handled only bystaff of listed customers as referred to in paragraph 2(e) inreasonably controlled conditions, in accordance with therequirements of legislation for the protection of workers andthe environment, and will not be made available to the generalpublic at any time either on its own or in a preparation or
article and that remaining quantities will be re-collected for
disposal after the exemption period.

29.5.2007
Article 10

Information to be submitted for general registration
purposes

A registration required by Article 6 or by Article 7(1) or (5)shall include all the following information:(a) a technical dossier including:In such cases, the Agency may ask the notifier to provide additional necessary information.

5.
In the absence of any indication to the contrary, themanufacturer or importer of the substance or the producer orimporter of articles may manufacture or import the substanceor produce or import the articles not earlier than two weeks
after the notification.

6.
The manufacturer or importer or producer of articles shallcomply with any conditions imposed by the Agency in accordance with paragraph 4.

(i) the identity of the manufacturer(s) or importer(s) as
specified in section 1 of Annex VI;(ii) the identity of the substance as specified in section 2of Annex VI;(iii) information on the manufacture and use(s) of thesubstance as specified in section 3 of Annex VI; thisinformation shall represent all the registrant's identified use(s). This information may include, if the registrant deems appropriate, the relevant use and exposure
categories;(iv) the classification and labelling of the substance as
specified in section 4 of Annex VI;(v) guidance on safe use of the substance as specified in
Section 5 of Annex VI;

7.
The Agency may decide to extend the five-year exemption
period by a further maximum of five years or, in the case of
substances to be used exclusively in the development of medicinal products for human or veterinary use, or for substancesthat are not placed on the market, for a further maximum often years, upon request if the manufacturer or importer or
producer of articles can demonstrate that such an extension isjustified by the research and development programme.

8.
The Agency shall forthwith communicate any draft decisions to the competent authorities of each Member State inwhich the manufacture, import, production or product andprocess orientated research takes place.

When taking decisions as provided for in paragraphs 4 and 7,
the Agency shall take into account any comments made by suchcompetent authorities.

(vi) study summaries of the information derived from theapplication of Annexes VII to XI;(vii) robust study summaries of the information derived
from the application of Annexes VII to XI, if required
under Annex I;(viii) an indication as to which of the information submitted
under (iii), (iv), (vi), (vii) or subparagraph (b) has beenreviewed by an assessor chosen by the manufacturer
or importer and having appropriate experience;(ix) proposals for testing where listed in Annexes IX andX;(x) for substances in quantities of 1 to 10 tonnes, exposure information as specified in section 6 of Annex VI;

9.
The Agency and the competent authorities of the Member
States concerned shall always keep confidential the information
submitted in accordance with paragraphs 1 to 8.

(xi) a request as to which of the information in Article 119(2) the manufacturer or importer considers should not
be made available on the Internet in accordance with
Article 77(2)(e), including a justification as to why
publication could be harmful for his or any otherconcerned party's commercial interests.

10.
An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraphs 4
and 7 of this Article.

Except in cases covered under Article 25(3), Article 27(6) or
Article 30(3), the registrant shall be in legitimate possessionof or have permission to refer to the full study reportsummarised under (vi) and (vii) for the purpose of registration;

29.5.2007

Official Journal of the European UnionEN(b) a chemical safety report when required under Article 14, inthe format specified in Annex I. The relevant sections of thisreport may include, if the registrant considers appropriate,
the relevant use and exposure categories.

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lead to substantial commercial detriment or the nature of thedisagreement, as the case may be.

4. A submission for registration shall be accompanied by thefee required in accordance with Title IX.
Article 11

Joint submission of data by multiple registrants
Article 12
1.
When a substance is intended to be manufactured in theCommunity by one or more manufacturers and/or imported by
one or more importers, and/or is subject to registration under
Article 7, the following shall apply.

Information to be submitted depending on tonnage

Subject to paragraph 3, the information specified in Article 10(a)(iv), (vi), (vii) and (ix), and any relevant indication under
Article 10(a)(viii) shall first be submitted by the one registrant
acting with the agreement of the other assenting registrant(s)(hereinafter referred to as the lead registrant).

1. The technical dossier referred to in Article 10(a) shall
include under points (vi) and (vii) of that provision all physicochemical, toxicological and ecotoxicological information that isrelevant and available to the registrant and as a minimum thefollowing:

Each registrant shall subsequently submit separately the information specified in Article 10(a)(i), (ii), (iii) and (x), and any relevant indication under Article 10(a)(viii).

(a) the information specified in Annex VII for non-phase-in
substances, and for phase-in substances meeting one orboth of the criteria specified in Annex III, manufactured orimported in quantities of one tonne or more per year per
manufacturer or importer;

The registrants may decide themselves whether to submit the
information specified in Article 10(a)(v) and (b) and any relevant
indication under Article 10(a)(viii) separately or whether one
registrant is to submit this information on behalf of the others.

2.
Each registrant need only comply with paragraph 1 foritems of information specified in Article 10(a)(iv), (vi), (vii) and(ix) that are required for the purposes of registration within his
tonnage band in accordance with Article 12.

3.
A registrant may submit the information referred to in
Article 10(a)(iv), (vi), (vii) or (ix) separately if:(a) it would be disproportionately costly for him to submit thisinformation jointly; or(b) submitting the information jointly would lead to disclosureof information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or(c) he disagrees with the lead registrant on the selection of thisinformation.
If points (a), (b) or (c) apply, the registrant shall submit, alongwith the dossier, an explanation as to why the costs would be
disproportionate, why disclosure of information was likely to(b) the information on physicochemical properties specified in
Annex VII, section 7 for phase-in substances manufactured
or imported in quantities of one tonne or more per year per
manufacturer or importer which do not meet either of thecriteria specified in Annex III;(c) the information specified in Annexes VII and VIII for
substances manufactured or imported in quantities of
10 tonnes or more per year per manufacturer or importer;(d) the information specified in Annexes VII and VIII andtesting proposals for the provision of the information specified in Annex IX for substances manufactured or imported
in quantities of 100 tonnes or more per year per manufacturer or importer;(e) the information specified in Annexes VII and VIII andtesting proposals for the provision of the information specified in Annexes IX and X for substances manufactured orimported in quantities of 1 000 tonnes or more per year
per manufacturer or importer.
2. As soon as the quantity of a substance per manufacturer
or importer that has already been registered reaches the next
tonnage threshold, the manufacturer or importer shall informthe Agency immediately of the additional information he would
require under paragraph 1. Article 26(3) and (4) shall apply
adapted as necessary.

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EN

3.
This Article shall apply to producers of articles adapted asnecessary.

Article 13

General requirements for generation of information on
intrinsic properties of substances

1.
Information on intrinsic properties of substances may begenerated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by meansother than vertebrate animal tests, through the use of alternative
methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from informationfrom structurally related substances (grouping or read-across).
Testing in accordance with Annex VIII, Sections 8.6 and 8.7,
Annex IX and Annex X may be omitted where justified by information on exposure and implemented risk management
measures as specified in Annex XI, section 3.

2.
These methods shall be regularly reviewed and improved
with a view to reducing testing on vertebrate animals and thenumber of animals involved. The Commission, following
consultation with relevant stakeholders, shall, as soon as
possible, make a proposal, if appropriate, to amend theCommission Regulation on test methods adopted in accordancewith the procedure referred to in Article 133(4), and theAnnexes of this Regulation, if relevant, so as to replace, reduceor refine animal testing. Amendments to that Commission
Regulation shall be adopted in accordance with the procedure
specified in paragraph 3 and amendments to the Annexes ofthis Regulation shall be adopted in accordance with the procedure referred to in Article 131.

3.
Where tests on substances are required to generate information on intrinsic properties of substances, they shall be
conducted in accordance with the test methods laid down in a
Commission Regulation or in accordance with other international test methods recognised by the Commission or the
Agency as being appropriate. The Commission shall adopt that
Regulation, designed to amend the non-essential elements ofthis Regulation by supplementing it, in accordance with theprocedure referred to in Article 133(4).

29.5.2007

4. Ecotoxicological and toxicological tests and analyses shallbe carried out in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC or otherinternational standards recognised as being equivalent by theCommission or the Agency and with the provisions of Directive 86/609/EEC, if applicable.

5. If a substance has already been registered, a new registrant
shall be entitled to refer to the study summaries or robust study
summaries, for the same substance submitted earlier, provided
that he can show that the substance that he is now registering is
the same as the one previously registered, including the degreeof purity and the nature of impurities, and that the previous
registrant(s) have given permission to refer to the full study
reports for the purpose of registration.

A new registrant shall not refer to such studies in order toprovide the information required in Section 2 of Annex VI.

Article 14

Chemical safety report and duty to apply and recommend
risk reduction measures

1. Without prejudice to Article 4 of Directive 98/24/EC, achemical safety assessment shall be performed and a chemicalsafety report completed for all substances subject to registrationin accordance with this Chapter in quantities of 10 tonnes ormore per year per registrant.

The chemical safety report shall document the chemical safetyassessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its
own or in a preparation or in an article or a group of
substances.

2. A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present
in a preparation if the concentration of the substance in the
preparation is less than the lowest of any of the following:(a) the applicable concentrations defined in the table of
Article 3(3) of Directive 1999/45/EC;(b) the concentration limits given in Annex I to Directive 67/
548/EEC;(c) the concentration limits given in Part B of Annex II to
Directive 1999/45/EC;

Information on intrinsic properties of substances may be generated in accordance with other test methods provided that theconditions set out in Annex XI are met.

(d) the concentration limits given in Part B of Annex III to
Directive 1999/45/EC;

29.5.2007

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Official Journal of the European Union(e) the concentration limits given in an agreed entry in the classification and labelling inventory established under Title XIof this Regulation;

L 136/27

6. Any registrant shall identify and apply the appropriate
measures to adequately control the risks identified in thechemical safety assessment, and where suitable, recommend
them in the safety data sheets which he supplies in accordancewith Article 31.

(f) 0,1 % weight by weight (w/w), if the substance meets thecriteria in Annex XIII of this Regulation.

3.
A chemical safety assessment of a substance shall include
the following steps:(a) human health hazard assessment;(b) physicochemical hazard assessment;

7. Any registrant required to conduct a chemical safetyassessment shall keep his chemical safety report available andup to date.

CHAPTER 2

Substances regarded as being registered(c) environmental hazard assessment;(d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.

4.
If, as a result of carrying out steps (a) to (d) of paragraph 3,
the registrant concludes that the substance meets the criteria forclassification as dangerous in accordance with Directive 67/548/
EEC or is assessed to be a PBT or vPvB, the chemical safetyassessment shall include the following additional steps:(a) exposure assessment including the generation of exposure
scenario(s) (or the identification of relevant use and exposure categories if appropriate) and exposure estimation;(b) risk characterisation.

The exposure scenarios (where appropriate the use and exposure
categories), exposure assessment and risk characterisation shalladdress all identified uses of the registrant.

5.
The chemical safety report need not include considerationof the risks to human health from the following end uses:(a) in food contact materials within the scope of Regulation(EC) No 1935/2004 of the European Parliament and of theCouncil of 27 October 2004 on materials and articles
intended to come into contact with food (1);(b) in cosmetic products within the scope of Directive 76/768/
EEC.
(1) OJ L 338, 13.11.2004, p. 4.

Article 15

Substances in plant protection and biocidal products

1. Active substances and co-formulants manufactured orimported for use in plant protection products only and included
either in Annex I to Council Directive 91/414/EEC (2) or in
Commission Regulation (EEC) No 3600/92 (3), Commission
Regulation (EC) No 703/2001 (4), Commission Regulation (EC)No 1490/2002 (5), or Commission Decision 2003/565/EC (6)and for any substance for which a Commission Decision on thecompleteness of the dossier has been taken pursuant to Article 6
of Directive 91/414/EEC shall be regarded as being registeredand the registration as completed for manufacture or import for
the use as a plant protection product and therefore as fulfilling
the requirements of Chapters 1 and 5 of this Title.
(2) Council Directive 91/414/EEC of 15 July 1991 concerning the placingof plant protection products on the market (OJ L 230, 19.8.1991, p. 1).
Directive as last amended by Commission Directive 2006/136/EC (OJ
L 349, 12.12.2006, p. 42).
3( ) Commission Regulation (EEC) No 3600/92 of 11 December 1992
laying down the detailed rules for the implementation of the first stageof the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection productson the market (OJ L 366, 15.12.1992, p. 10). Regulation as last
amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000,
p. 27).
4( ) Commission Regulation (EC) No 703/2001 of 6 April 2001 laying
down the active substances of plant protection products to be assessedin the second stage of the work programme referred to in Article 8(2)of Council Directive 91/414/EEC and revising the list of Member States
designated as rapporteurs for those substances (OJ L 98, 7.4.2001,
p. 6).
5( ) Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying
down further detailed rules for the implementation of the third stage ofthe programme of work referred to in Article 8(2) of Council Directive
91/414/EEC (OJ L 224, 21.8.2002, p. 23). Regulation as last amended
by Regulation (EC) No 1744/2004 (OJ L 311, 8.10.2004, p. 23).
(6) Commission Decision 2003/565/EC of 25 July 2003 extending thetime period provided for in Article 8(2) of Council Directive
91/414/EEC (OJ L 192, 31.7.2003, p. 40).

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2.
Active substances manufactured or imported for use inbiocidal products only and included either in Annexes I, IA or
IB to Directive 98/8/EC of the European Parliament and of theCouncil of 16 February 1998 concerning the placing of biocidal
products on the market (1) or in Commission Regulation (EC)No 2032/2003 (2)on the second phase of the 10-year work
programme referred to in Article 16(2) of Directive 98/8/EC,
until the date of the decision referred to in the second subparagraph of Article 16(2) of Directive 98/8/EC, shall be
regarded as being registered and the registration as completed
for manufacture or import for the use in a biocidal product andtherefore as fulfilling the requirements of Chapters 1 and 5 ofthis Title.

Article 16
Duties of the Commission, the Agency and registrants ofsubstances regarded as being registered
1.
The Commission or the relevant Community body shallmake information equivalent to that required by Article 10available to the Agency for substances regarded as registeredaccording to Article 15. The Agency shall include this information or a reference thereto in its databases and notify thecompetent authorities thereof by 1 December 2008.
2.
Articles 21, 22 and 25 to 28 shall not apply to uses ofsubstances regarded as registered according to Article 15.

29.5.2007(d) any available existing information on physicochemical,
human health or environmental properties of the intermediate. Where a full study report is available, a study
summary shall be submitted;(e) a brief general description of the use, as specified in
Section 3.5 of Annex VI;(f) details of the risk management measures applied.
Except in cases covered under Article 25(3), Article 27(6) or
Article 30(3), the registrant shall be in legitimate possession ofor have permission to refer to the full study report summarised
under (d) for the purpose of registration.
The registration shall be accompanied by the fee required inaccordance with Title IX.
3. Paragraph 2 shall apply only to on-site isolated intermediates if the manufacturer confirms that the substance is only
manufactured and used under strictly controlled conditions inthat it is rigorously contained by technical means during its
whole lifecycle. Control and procedural technologies shall be
used to minimise emission and any resulting exposure.
If these conditions are not fulfilled, the registration shall include
the information specified in Article 10.

CHAPTER 3

Article 18
Obligation to register and information requirements forcertain types of isolated intermediates
Registration of transported isolated intermediates

Registration of on-site isolated intermediates

1. Any manufacturer or importer of a transported isolated
intermediate in quantities of one tonne or more per year shallsubmit a registration to the Agency for the transported isolated
intermediate.

1.
Any manufacturer of an on-site isolated intermediate inquantities of one tonne or more per year shall submit a registration to the Agency for the on-site isolated intermediate.

2. A registration for a transported isolated intermediate shall
include all the following information:

Article 17

2.
A registration for an on-site isolated intermediate shall
include all the following information, to the extent that the
manufacturer is able to submit it without any additional testing:(a) the identity of the manufacturer as specified in Section 1 ofAnnex VI;(b) the identity of the intermediate as specified in Sections 2.1
to 2.3.4 of Annex VI;(c) the classification of the intermediate as specified in Section 4of Annex VI;(1) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission
Directive 2006/140/EC (OJ L 414, 30.12.2006, p. 78).
(2) OJ L 307, 24.11.2003, p. 1. Regulation as last amended by Regulation(EC) No 1849/2006 (OJ L 355, 15.12.2006, p. 63).

(a) the identity of the manufacturer or importer as specified in
Section 1 of Annex VI;(b) the identity of the intermediate as specified in Sections 2.1
to 2.3.4 of Annex VI;(c) the classification of the intermediate as specified in Section 4of Annex VI;(d) any available existing information on physicochemical,
human health or environmental properties of the intermediate. Where a full study report is available, a study
summary shall be submitted;(e) a brief general description of the use, as specified in
Section 3.5 of Annex VI;

29.5.2007

Official Journal of the European UnionEN(f) information on risk management measures applied andrecommended to the user in accordance with paragraph 4.
Except in cases covered under Article 25(3), Article 27(6) or
Article 30(3), the registrant shall be in legitimate possession ofor have permission to refer to the full study report summarised
under (d) for the purpose of registration.
The registration shall be accompanied by the fee required inaccordance with Title IX.
3.
A registration for a transported isolated intermediate inquantities of more than 1 000 tonnes per year per manufacturer
or importer shall include the information specified in Annex VII
in addition to the information required under paragraph 2.

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Community by one or more manufacturers and/or imported by
one or more importers, the following shall apply.
Subject to paragraph 2 of this Article, the information specified
in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall firstbe submitted by one manufacturer or importer acting with theagreement of the other assenting manufacturer(s) or importer(s)(hereinafter referred to as ‘the lead registrant’).
Each registrant shall subsequently submit separately the information specified in Article 17(2)(a), (b), (e) and (f) and Article 18(2)(a),(b), (e) and (f).
2. A manufacturer or importer may submit the informationreferred to in Article 17(2)(c) or (d) and Article 18(2)(c) or (d)separately if:

For the generation of this information, Article 13 shall apply.
4.
Paragraphs 2 and 3 shall apply only to transported
isolated intermediates if the manufacturer or importer confirms
himself or states that he has received confirmation from theuser that the synthesis of (an)other substance(s) from that intermediate takes place on other sites under the following strictly
controlled conditions:(a) the substance is rigorously contained by technical means
during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling,
analysis, loading and unloading of equipment or vessels,
waste disposal or purification and storage;(a) it would be disproportionately costly for him to submit thisjointly; or(b) submitting the information jointly would lead to disclosureof information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or(c) he disagrees with the lead registrant on the selection of thisinformation.

(b) procedural and control technologies shall be used that minimise emission and any resulting exposure;

If points (a), (b) or (c) apply, the manufacturer or importer shallsubmit, along with the dossier, an explanation as to why thecosts would be disproportionate, why disclosure of information
was likely to lead to substantial commercial detriment, or thenature of the disagreement, as the case may be.

(c) only properly trained and authorised personnel handle thesubstance;

3. A submission for registration shall be accompanied by thefee required in accordance with Title IX.

(d) in the case of cleaning and maintenance works, special
procedures such as purging and washing are applied before
the system is opened and entered;

CHAPTER 4(e) in cases of accident and where waste is generated, procedural and/or control technologies are used to minimiseemissions and the resulting exposure during purification or
cleaning and maintenance procedures;

Common provisions for all registrations

Article 20(f) substance-handling procedures are well documented andstrictly supervised by the site operator.
If the conditions listed in the first subparagraph are not fulfilled,
the registration shall include the information specified in
Article 10.

Duties of the Agency
1. The Agency shall assign a submission number to eachregistration, which is to be used for all correspondence
regarding the registration until the registration is deemed to becomplete, and a submission date, which shall be the date ofreceipt of the registration at the Agency.

Article 19
Joint submission of data on isolated intermediates bymultiple registrants
1.
When an on-site isolated intermediate or transported
isolated intermediate is intended to be manufactured in the

2. The Agency shall undertake a completeness check of eachregistration in order to ascertain that all the elements required
under Articles 10 and 12 or under Articles 17 or 18, as well as
the registration fee referred to in Article 6(4), Article 7(1) and(5), Article 17(2) or Article 18(2), have been provided. The
completeness check shall not include an assessment of thequality or the adequacy of any data or justifications submitted.

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The Agency shall undertake the completeness check within
three weeks of the submission date, or within three months of
the relevant deadline of Article 23, as regards registrations ofphase-in substances submitted in the course of the two-month
period immediately preceding that deadline.

If a registration is incomplete, the Agency shall inform the registrant, before expiry of the three-week or three-month period
referred to in the second subparagraph, as to what further information is required in order for the registration to be complete,
while setting a reasonable deadline for this. The registrant shallcomplete his registration and submit it to the Agency within thedeadline set. The Agency shall confirm the submission date of
the further information to the registrant. The Agency shallperform a further completeness check, considering the further
information submitted.

29.5.2007

5. An appeal may be brought, in accordance with Articles 91,
92 and 93, against Agency decisions under paragraph 2 of this
Article.

6. Where additional information for a particular substance issubmitted to the Agency by a new registrant, the Agency shallnotify the existing registrants that this information is available
on the database for the purposes of Article 22.

Article 21

Manufacturing and import of substances
The Agency shall reject the registration if the registrant fails tocomplete his registration within the deadline set. The registration fee shall not be reimbursed in such cases.

3.
Once the registration is complete, the Agency shall assign
a registration number to the substance concerned and a registration date, which shall be the same as the submission date. The
Agency shall without delay communicate the registration
number and registration date to the registrant concerned. The
registration number shall be used for all subsequent correspondence regarding registration.

4.
The Agency shall notify the competent authority of therelevant Member State within 30 days of the submission date,that the following information is available in the Agency database:(a) the registration dossier together with the submission orregistration number;(b) the submission or registration date;(c) the result of the completeness check; and(d) any request for further information and deadline set inaccordance with the third subparagraph of paragraph 2.
The relevant Member State shall be the Member State within
which the manufacture takes place or the importer is established.

If the manufacturer has production sites in more than one
Member State, the relevant Member State shall be the one inwhich the head office of the manufacturer is established. The
other Member States where the production sites are establishedshall also be notified.

The Agency shall forthwith notify the competent authority of
the relevant Member State(s) when any further information
submitted by the registrant is available on the Agency database.

1. A registrant may start or continue the manufacture or
import of a substance or production or import of an article, if
there is no indication to the contrary from the Agency inaccordance with Article 20(2) within the three weeks after thesubmission date, without prejudice to Article 27(8).

In the case of registrations of phase-in substances, such a registrant may continue the manufacture or import of the substanceor production or import of an article, if there is no indication
to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the submission date or, if
submitted within the two-month period before the relevant
deadline of Article 23, if there is no indication to the contraryfrom the Agency in accordance with Article 20(2) within thethree months from that deadline, without prejudice to Article 27(8).

In the case of an update of a registration according to Article 22a registrant may continue the manufacture or import of thesubstance, or the production or import of the article, if there isno indication to the contrary from the Agency in accordancewith Article 20(2) within the three weeks after the update date,
without prejudice to Article 27(8).

2. If the Agency has informed the registrant that he is tosubmit further information in accordance with the third subparagraph of Article 20(2), the registrant may start the manufacture or import of a substance or production or import of anarticle if there is no indication to the contrary from the Agency
within the three weeks after receipt by the Agency of thefurther information necessary to complete his registration,
without prejudice to Article 27(8).

3. If a lead registrant submits parts of the registration on
behalf of one or more other registrants, as provided for in Articles 11 or 19, any of the other registrants may manufacture or
import the substance or produce or import the articles only
after the expiry of the time-limit laid down in paragraph 1 or 2of this Article and provided that there is no indication to thecontrary from the Agency in respect of the registration of thelead registrant acting on behalf of the others and his own registration.

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Article 22
Further duties of registrants
1.
Following registration, a registrant shall be responsible on
his own initiative for updating his registration without undue
delay with relevant new information and submitting it to the
Agency in the following cases:(a) any change in his status, such as being a manufacturer, an
importer or a producer of articles, or in his identity, such as
his name or address;

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4. In cases covered by Articles 11 or 19, each registrant shallsubmit separately the information specified in paragraph 1(c) of
this Article.
5. An update shall be accompanied by the relevant part of
the fee required in accordance with Title IX.
CHAPTER 5

Transitional provisions applicable to phase-in substances andnotified substances(b) any change in the composition of the substance as given in
Section 2 of Annex VI;
Article 23(c) changes in the annual or total quantities manufactured orimported by him or in the quantities of substances present
in articles produced or imported by him if these result in achange of tonnage band, including cessation of manufacture
or import;(d) new identified uses and new uses advised against as in
Section 3.7 of Annex VI for which the substance is manufactured or imported;(e) new knowledge of the risks of the substance to humanhealth and/or the environment of which he may reasonably
be expected to have become aware which leads to changes
in the safety data sheet or the chemical safety report;(f) any change in the classification and labelling of thesubstance;(g) any update or amendment of the chemical safety report or
Section 5 of Annex VI;(h) the registrant identifies the need to perform a test listed in
Annex IX or Annex X, in which cases a testing proposal
shall be developed;(i) any change in the access granted to information in the registration.
The Agency shall communicate this information to the competent authority of the relevant Member State.
2.
A registrant shall submit to the Agency an update of theregistration containing the information required by the decision
made in accordance with Articles 40, 41 or 46 or take into
account a decision made in accordance with Articles 60 and 73,
within the deadline specified in that decision. The Agency shallnotify the competent authority of the relevant Member State
that the information is available on its database.
3.
The Agency shall undertake a completeness checkaccording to Article 20(2) first and second subparagraphs ofeach updated registration. In cases where the update is inaccordance with Article 12(2) and with paragraph 1(c) of this
Article then the Agency shall check the completeness of theinformation supplied by the registrant and Article 20(2) shallapply adapted as necessary.

Specific provisions for phase-in substances
1. Article 5, Article 6, Article 7(1), Article 17, Article 18 and
Article 21 shall not apply until 1 December 2010 to thefollowing substances:(a) phase-in substances classified as carcinogenic, mutagenic or
toxic to reproduction, category 1 or 2, in accordance with
Directive 67/548/EEC and manufactured in the Community
or imported, in quantities reaching one tonne or more per
year per manufacturer or per importer, at least once after
1 June 2007;(b) phase-in substances classified as very toxic to aquatic organisms which may cause long-term adverse effects in theaquatic environment (R50/53) in accordance with Directive
67/548/EEC, and manufactured in the Community orimported in quantities reaching 100 tonnes or more per
year per manufacturer or per importer, at least once after
1 June 2007;(c) phase-in substances manufactured in the Community orimported, in quantities reaching 1 000 tonnes or more per
year per manufacturer or per importer, at least once after
1 June 2007.
2. Article 5, Article 6, Article 7(1), Article 17, Article 18 and
Article 21 shall not apply until 1 June 2013 to phase-in
substances manufactured in the Community or imported, inquantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007.
3. Article 5, Article 6, Article 7(1), Article 17, Article 18 and
Article 21 shall not apply until 1 June 2018 to phase-in
substances manufactured in the Community or imported, inquantities reaching one tonne or more per year per manufacturer or per importer, at least once after 1 June 2007.
4. Without prejudice to paragraphs 1 to 3, a registration canbe submitted at any time before the relevant deadline.
5. This Article shall also apply to substances registered under
Article 7 adapted as necessary.

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Article 24

registered in accordance with Article 28, shall inquire from the
Agency whether a registration has already been submitted forthe same substance. He shall submit all the following information to the Agency with the inquiry:

Notified substances1.
A notification in accordance with Directive 67/548/EEC
shall be regarded as a registration for the purposes of this Title
and the Agency shall assign a registration number by
1 December 2008.
2.
If the quantity of a notified substance manufactured orimported per manufacturer or importer reaches the next
tonnage threshold under Article 12, the additional required
information corresponding to that tonnage threshold, as well as
to all the lower tonnage thresholds, shall be submitted inaccordance with Articles 10 and 12, unless it has already been
submitted in accordance with those Articles.
TITLE IIIDATASHARINGANDAVOIDANCETESTING

29.5.2007(a) his identity as specified in Section 1 of Annex VI, with the
exception of the use sites;(b) the identity of the substance, as specified in Section 2 ofAnnex VI;(c) which information requirements would require new studies
involving vertebrate animals to be carried out by him;(d) which information requirements would require other new
studies to be carried out by him.
2. If the same substance has previously not been registered,
the Agency shall inform the potential registrant accordingly.

OF

UNNECESSARY

CHAPTER 1

Objectives and general rules

Article 25

3. If the same substance has previously been registered lessthan 12 years earlier, the Agency shall inform the potential
registrant without delay of the names and addresses of theprevious registrant(s) and of the relevant summaries or robust
study summaries, as the case may be, already submitted bythem.
Studies involving vertebrate animals shall not be repeated.

Objectives and general rules
1.
In order to avoid animal testing, testing on vertebrate
animals for the purposes of this Regulation shall be undertaken
only as a last resort. It is also necessary to take measures
limiting duplication of other tests.
2.
The sharing and joint submission of information inaccordance with this Regulation shall concern technical dataand in particular information related to the intrinsic properties
of substances. Registrants shall refrain from exchanging information concerning their market behaviour, in particular as
regards production capacities, production or sales volumes,
import volumes or market shares.
3.
Any study summaries or robust study summaries ofstudies submitted in the framework of a registration under thisRegulation at least 12 years previously can be used for the
purposes of registration by another manufacturer or importer.
CHAPTER 2

Rules for non-phase-in substances and registrants of phase-in
substances who have not pre-registered

The Agency shall simultaneously inform the previous registrantsof the name and address of the potential registrant. The available studies shall be shared with the potential registrant inaccordance with Article 27.
4. If several potential registrants have made an inquiry inrespect of the same substance, the Agency shall inform all
potential registrants without delay of the name and address ofthe other potential registrants.

Article 27
Sharing of existing data in the case of registered substances
1. Where a substance has previously been registered less than
12 years earlier as referred to in Article 26(3), the potential
registrant:(a) shall, in the case of information involving tests on vertebrate
animals; andArticle 26(b) may, in the case of information not involving tests on vertebrate animals,

Duty to inquire prior to registration
1.
Every potential registrant of a non-phase-in substance, or
potential registrant of a phase-in substance who has not pre-request from the previous registrant(s) the information herequires with respect to Article 10(a)(vi) and (vii) in order toregister.

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2.
When a request for information has been made according
to paragraph 1, the potential and the previous registrant(s) as
referred to in paragraph 1 shall make every effort to reach an
agreement on the sharing of the information requested by thepotential registrant(s) with respect to Article 10(a)(vi) and (vii).
Such an agreement may be replaced by submission of thematter to an arbitration board and acceptance of the arbitration
order.

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CHAPTER 3

Rules for phase-in-substances

Article 28
3.
The previous registrant and potential registrant(s) shallmake every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way. This may be facilitated by following cost sharing
guidance based on those principles which is adopted by the
Agency in accordance with Article 77(2)(g). Registrants are only
required to share in the costs of information that they are
required to submit to satisfy their registration requirements.

4.
On agreement on the sharing of the information, theprevious registrant shall make available to the new registrant theagreed information and shall give the new registrant the permission to refer to the previous registrant's full study report.

5.
If there is failure to reach such an agreement, the potential
registrant(s) shall inform the Agency and the previous registrant(s) thereof at the earliest one month after receipt, from the
Agency, of the name and address of the previous registrant(s).

6.
Within one month from the receipt of the informationreferred to in paragraph 5, the Agency shall give the potential
registrant permission to refer to the information requested byhim in his registration dossier, subject to the potential registrant
providing, upon request by the Agency, proof that he has paid
the previous registrant(s) for that information a share of cost
incurred. The previous registrant(s) shall have a claim on thepotential registrant for a proportionate share of the cost
incurred by him. Calculation of the proportionate share may befacilitated by the guidance adopted by the Agency in accordancewith Article 77(2)(g). Provided he makes the full study reportavailable to the potential registrant, the previous registrant(s)shall have a claim on the potential registrant for an equal shareof the cost incurred by him, which shall be enforceable in thenational courts.

7.
An appeal may be brought, in accordance with Articles 91,
92 and 93, against Agency decisions under paragraph 6 of this
Article.

8.
The registration waiting period in accordance with
Article 21(1) for the new registrant shall be extended by aperiod of four months, if the previous registrant so requests.

Duty to pre-register for phase-in substances

1. In order to benefit from the transitional regime provided
for in Article 23 each potential registrant of a phase-in
substance in quantities of one tonne or more per year, including
without limitation intermediates, shall submit all the following
information to the Agency:(a) the name of the substance as specified in Section 2 ofAnnex VI, including its EINECS and CAS number or, if notavailable, any other identity codes;(b) his name and address and the name of the contact person
and, where appropriate, the name and address of the person
representing him in accordance with Article 4 as specified
in Section 1 of Annex VI;(c) the envisaged deadline for the registration and the tonnageband;(d) the name(s) of substance(s) as specified in Section 2 ofAnnex VI, including their EINECS and CAS number or, if
not available, any other identity codes, for which the available information is relevant for the application ofSections 1.3 and 1.5 of Annex XI.
2. The information referred to in paragraph 1 shall be
submitted within a time period starting on 1 June 2008 andending on 1 December 2008.

3. Registrants who do not submit the information required
under paragraph 1 shall not be able to rely on Article 23.

4. The Agency shall by 1 January 2009 publish on its
website a list of the substances referred to in paragraph 1(a) and(d). That list shall comprise only the names of the substances,including their EINECS and CAS number if available and otheridentity codes, and the first envisaged registration deadline.

5. After the publication of the list a downstream user of a
substance not appearing on the list may notify the Agency of
his interest in the substance, his contact details and the detailsof his current supplier. The Agency shall publish on its website
the name of the substance and on request provide contact
details of the downstream user to a potential registrant.

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6.
Potential registrants who manufacture or import for the
first time a phase-in substance in quantities of one tonne ormore per year or use for the first time a phase-in substance inthe context of production of articles or import for the first time
an article containing a phase-in substance that would requireregistration, after 1 December 2008, shall be entitled to rely on
Article 23 provided that they submit the information referred toin paragraph 1 of this Article to the Agency within six monthsof first manufacturing, importing or using the substance inquantities of one tonne or more per year and no later than 12
months before the relevant deadline in Article 23.
7.
Manufacturers or importers of phase-in substances inquantities of less than one tonne per year that appear on the list
published by the Agency in accordance with paragraph 4 of this
Article, as well as downstream users of those substances andthird parties holding information on those substances, may
submit the information referred to in paragraph 1 of this
Article or any other relevant information to the Agency for
those substances, with the intention of being part of thesubstance information exchange forum as referred to in
Article 29.

29.5.2007

communicating within his SIEF. If a relevant study involving
tests on vertebrate animals is available within the SIEF, a participant of that SIEF shall request that study. If a relevant study not
involving tests on vertebrate animals is available within the SIEF,
a SIEF participant may request that study.

Within one month of the request, the owner of the study shallprovide proof of its cost to the participant(s) requesting it. The
participant(s) and the owner shall make every effort to ensurethat the costs of sharing the information are determined in afair, transparent and non discriminatory way. This may be facilitated by following any cost sharing guidance which is based on
those principles and is adopted by the Agency in accordancewith Article 77(2)(g). If they cannot reach such an agreement,
the cost shall be shared equally. The owner shall give permission
to refer to the full study report for the purpose of registration
within two weeks of receipt of payment. Registrants are only
required to share in the costs of information that they are
required to submit to satisfy their registration requirements.

Article 29
Substance Information Exchange Forums
1.
All potential registrants, downstream users and third
parties who have submitted information to the Agency inaccordance with Article 28, or whose information is held by the
Agency in accordance with Article 15, for the same phase-in
substance, or registrants who have submitted a registration forthat phase-in substance before the deadline set out in Article 23(3), shall be participants in a substance information exchange
forum (SIEF).
2.

The aim of each SIEF shall be to:(a) facilitate, for the purposes of registration, the exchange ofthe information specified in Article 10(a) (vi) and (vii)
between potential registrants, thereby avoiding the duplication of studies; and(b) agree classification and labelling where there is a differencein the classification and labelling of the substance between
potential registrants.
3.
SIEF participants shall provide other participants withexisting studies, react to requests by other participants for information, collectively identify needs for further studies for the
purposes of paragraph 2(a) and arrange for such studies to be
carried out. Each SIEF shall be operational until 1 June 2018.

Article 30
Sharing of data involving tests
1.
Before testing is carried out in order to meet the information requirements for the purposes of registration, a SIEF participant shall inquire whether a relevant study is available by

2. If a relevant study involving tests is not available within
the SIEF, only one study shall be conducted per information
requirement within each SIEF by one of its participants acting
on behalf of the others. They shall take all reasonable steps toreach an agreement within a deadline set by the Agency as towho is to carry out the test on behalf of the other participants
and to submit a summary or robust study summary to the
Agency. If no agreement is reached, the Agency shall specify
which registrant or downstream user shall perform the test. All
participants of the SIEF who require a study shall contribute to
the costs for the elaboration of the study with a share corresponding to the number of participating potential registrants.
Those participants that do not carry out the study themselves
shall have the right to receive the full study report within two
weeks following payment to the participant that carried out the
study.

3. If the owner of a study as referred to in paragraph 1
which involves testing on vertebrate animals refuses to provide
either proof of the cost of that study or the study itself to (an)other participant(s), he shall not be able to proceed with registration until he provides the information to the other participants(s). The other participant(s) shall proceed with registration
without fulfilling the relevant information requirement,
explaining the reason for this in the registration dossier. The
study shall not be repeated unless within 12 months of the dateof registration of the other participant(s), the owner of thisinformation has not provided it to them and the Agency decides
that the test should be repeated by them. However, if a registration containing this information has already been submitted byanother registrant, the Agency shall give the other participant(s)permission to refer to the information in his registration dossier(s). The other registrant shall have a claim on the other participant(s) for an equal share of the cost, provided he makes thefull study report available to the other participant(s), which shallbe enforceable in the national courts.

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EN

persistent, bioaccumulative and toxic or very persistent andvery bioaccumulative in accordance with the criteria set out
in Annex XIII or has been included for reasons other thanthose referred to in point (a) in the list established in accordance with Article 59(1); or

4.
If the owner of a study as referred to in paragraph 1
which does not involve testing on vertebrate animals refuses toprovide either proof of the cost of that study or the study itself
to (an)other participant(s), the other SIEF participants shallproceed with registration as if no relevant study was available in
the SIEF.
5.
An appeal may be brought, in accordance with Articles 91,
92 and 93, against Agency decisions under paragraphs 2 or 3of this Article.
6.
The owner of the study who has refused to provide either
proof of the cost or the study itself, as referred to in paragraph 3
or 4 of this Article, shall be penalised in accordance with
Article 126.
TITLE IVINFORMATION IN THE SUPPLY CHAIN

Article 31(c) a substance for which there are Community workplace
exposure limits.
4. The safety data sheet need not be supplied where
dangerous substances or preparations offered or sold to thegeneral public are provided with sufficient information to enable
users to take the necessary measures as regards the protection ofhuman health, safety and the environment, unless requested bya downstream user or distributor.
5. The safety data sheet shall be supplied in an official
language of the Member State(s) where the substance orpreparation is placed on the market, unless the Member State(s)concerned provide otherwise.
6. The safety data sheet shall be dated and shall contain thefollowing headings:
1.

identification of the substance/preparation and of thecompany/undertaking;2.

hazards identification;

3.

composition/information on ingredients;

4.

first-aid measures;

5.

fire-fighting measures;

6.

accidental release measures;

7.

handling and storage;

8.

exposure controls/personal protection;9.

physical and chemical properties;

Requirements for safety data sheets1.
The supplier of a substance or a preparation shall provide
the recipient of the substance or preparation with a safety data
sheet compiled in accordance with Annex II:(a) where a substance or preparation meets the criteria for classification as dangerous in accordance with Directives 67/
548/EEC or 1999/45/EC; or(b) where a substance is persistent, bioaccumulative and toxic
or very persistent and very bioaccumulative in accordancewith the criteria set out in Annex XIII; or(c) where a substance is included in the list established inaccordance with Article 59(1) for reasons other than thosereferred to in points (a) and (b).
2.
Any actor in the supply chain who is required, under Articles 14 or 37, to carry out a chemical safety assessment for a
substance shall ensure that the information in the safety data
sheet is consistent with the information in this assessment. If
the safety data sheet is developed for a preparation and theactor in the supply chain has prepared a chemical safety assessment for that preparation, it is sufficient if the information in
the safety data sheet is consistent with the chemical safety
report for the preparation instead of with the chemical safety
report for each substance in the preparation.
3.
The supplier shall provide the recipient at his request witha safety data sheet compiled in accordance with Annex II, wherea preparation does not meet the criteria for classification as
dangerous in accordance with Articles 5, 6 and 7 of Directive 1999/45/EC, but contains:(a) in an individual concentration of ≥ 1 % by weight for nongaseous preparations and ≥ 0,2 % by volume for gaseous
preparations at least one substance posing human health orenvironmental hazards; or(b) in an individual concentration of ≥ 0,1 % by weight for
non-gaseous preparations at least one substance that is

L 136/35

10. stability and reactivity;
11. toxicological information;
12. ecological information;
13. disposal considerations;14. transport information;
15. regulatory information;
16. other information.
7. Any actor in the supply chain who is required to prepare achemical safety report according to Articles 14 or 37 shall place
the relevant exposure scenarios (including use and exposure
categories where appropriate) in an annex to the safety data
sheet covering identified uses and including specific conditions
resulting from the application of Section 3 of Annex XI.
Any downstream user shall include relevant exposure scenarios,
and use other relevant information, from the safety data sheet
supplied to him when compiling his own safety data sheet for
identified uses.

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29.5.2007

Any distributor shall pass on relevant exposure scenarios, anduse other relevant information, from the safety data sheet
supplied to him when compiling his own safety data sheet foruses for which he has passed on information according to
Article 37(2).

latest at the time of the first delivery of a substance on its own
or in a preparation after 1 June 2007.

8.
A safety data sheet shall be provided free of charge on
paper or electronically.

(a) as soon as new information which may affect the risk
management measures, or new information on hazards
becomes available;

9.
Suppliers shall update the safety data sheet without delayon the following occasions:(b) once an authorisation has been granted or refused;(a) as soon as new information which may affect the risk
management measures, or new information on hazards
becomes available;(b) once an authorisation has been granted or refused;

3. Suppliers shall update this information without delay on
the following occasions:(c) once a restriction has been imposed.
In addition, the updated information shall be provided free ofcharge on paper or electronically to all former recipients towhom they have supplied the substance or preparation within
the preceding 12 months. Any updates following registration
shall include the registration number.

(c) once a restriction has been imposed.
The new, dated version of the information, identified as ‘Revision: (date)’, shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied thesubstance or preparation within the preceding 12 months. Any
updates following registration shall include the registration
number.

Article 32

Duty to communicate information down the supply chain
for substances on their own or in preparations for which asafety data sheet is not required

1.
Any supplier of a substance on its own or in a preparation
who does not have to supply a safety data sheet in accordancewith Article 31 shall provide the recipient with the following
information:(a) the registration number(s) referred to in Article 20(3), if
available, for any substances for which information iscommunicated under points (b), (c) or (d) of this paragraph;(b) if the substance is subject to authorisation and details of any
authorisation granted or denied under Title VII in this
supply chain;(c) details of any restriction imposed under Title VIII;

Article 33
Duty to communicate information on substances in articles
1. Any supplier of an article containing a substance meetingthe criteria in Article 57 and identified in accordance with
Article 59(1) in a concentration above 0,1 % weight by weight(w/w) shall provide the recipient of the article with sufficient
information, available to the supplier, to allow safe use of thearticle including, as a minimum, the name of that substance.
2. On request by a consumer any supplier of an article
containing a substance meeting the criteria in Article 57 andidentified in accordance with Article 59(1) in a concentration
above 0,1 % weight by weight (w/w) shall provide the consumer
with sufficient information, available to the supplier, to allow
safe use of the article including, as a minimum, the name ofthat substance.
The relevant information shall be provided, free of charge,
within 45 days of receipt of the request.

Article 34
Duty to communicate information on substances andpreparations up the supply chain(d) any other available and relevant information about thesubstance that is necessary to enable appropriate risk
management measures to be identified and applied including
specific conditions resulting from the application ofSection 3 of Annex XI.

Any actor in the supply chain of a substance or a preparation
shall communicate the following information to the next actor
or distributor up the supply chain:

2.
The information referred to in paragraph 1 shall be
communicated free of charge on paper or electronically at the(a) new information on hazardous properties, regardless of theuses concerned;

29.5.2007

Official Journal of the European UnionEN(b) any other information that might call into question theappropriateness of the risk management measures identified
in a safety data sheet supplied to him, which shall be
communicated only for identified uses.
Distributors shall pass on that information to the next actor or
distributor up the supply chain.

Article 35
Access to information for workers
Workers and their representatives shall be granted access by
their employer to the information provided in accordance with
Articles 31 and 32 in relation to substances or preparations
that they use or may be exposed to in the course of their work.

Article 36

L 136/37

with a substance on its own or in a preparation with the aim ofmaking this an identified use. In making a use known, he shallprovide sufficient information to allow the manufacturer,
importer or downstream user who has supplied the substance,
to prepare an exposure scenario, or if appropriate a use andexposure category, for his use in the manufacturer, importer ordownstream user's chemical safety assessment.

Distributors shall pass on such information to the next actor or
distributor up the supply chain. Downstream users in receipt ofsuch information may prepare an exposure scenario for theidentified use(s), or pass the information to the next actor up
the supply chain.

3. For registered substances, the manufacturer, importer ordownstream user shall comply with the obligations laid down in
Article 14 either before he next supplies the substance on its
own or in a preparation to the downstream user making therequest referred to in paragraph 2 of this Article, provided thatthe request was made at least one month before the supply, or
within one month after the request, whichever is the later.

Obligation to keep information
1.
Each manufacturer, importer, downstream user and distributor shall assemble and keep available all the information herequires to carry out his duties under this Regulation for aperiod of at least 10 years after he last manufactured, imported,
supplied or used the substance or preparation. That manufacturer, importer, downstream user or distributor shall submit thisinformation or make it available without delay upon request to
any competent authority of the Member State in which he isestablished or to the Agency, without prejudice to Titles II
and VI.
2.
In the event of a registrant, downstream user or distributor
ceasing activity, or transferring part or all of his operations to athird party, the party responsible for liquidating the registrant,
downstream user or distributor's undertaking or assuming
responsibility for the placing on the market of the substance orpreparation concerned shall be bound by the obligation in paragraph 1 in place of the registrant, downstream user or distributor.

For phase-in substances, the manufacturer, importer or downstream user shall comply with this request and with the obligations laid down in Article 14 before the relevant deadline in
Article 23 has expired, provided that the downstream user
makes his request at least 12 months before the deadline inquestion.

Where the manufacturer, importer or downstream user, havingassessed the use in accordance with Article 14, is unable toinclude it as an identified use for reasons of protection ofhuman health or the environment, he shall provide the Agency
and the downstream user with the reason(s) for that decision inwriting without delay and shall not supply downstream user(s)with the substance without including these reason(s) in theinformation referred to under Articles 31 or 32. The manufacturer or importer shall include this use in Section 3.7 ofAnnex VI in his update of the registration in accordance with
Article 22(1)(d).

TITLE VDOWNSTREAM USERS

Article 37
Downstream user chemical safety assessments and duty toidentify, apply and recommend risk reduction measures
1.
A downstream user or distributor may provide information to assist in the preparation of a registration.
2.
Any downstream user shall have the right to make a use,
as a minimum the brief general description of use, known in
writing (on paper or electronically) to the manufacturer,
importer, downstream user or distributor who supplies him

4. A downstream user of a substance on its own or in a
preparation shall prepare a chemical safety report in accordancewith Annex XII for any use outside the conditions described in
an exposure scenario or if appropriate a use and exposure category communicated to him in a safety data sheet or for any use
his supplier advises against.

A downstream user need not prepare such a chemical safety
report in any of the following cases:(a) a safety data sheet is not required to be communicated withthe substance or preparation in accordance with Article 31;(b) a chemical safety report is not required to be completed byhis supplier in accordance with Article 14;

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29.5.2007(c) the downstream user uses the substance or preparation in a
total quantity of less than one tonne per year;(a) the downstream user has to prepare a chemical safety reportin accordance with Article 37(4); or(d) the downstream user implements or recommends an exposure scenario which includes as a minimum the conditions
described in the exposure scenario communicated to him in
the safety data sheet;(b) the downstream user is relying on the exemptions in
Article 37(4)(c) or (f).

(e) the substance is present in a preparation in a concentration
lower than any of the concentrations set out in Article 14(2);(f) the downstream user is using the substance for the purposesof product and process oriented research and development,
provided that the risks to human health and the environment are adequately controlled in accordance with therequirements of legislation for the protection of workers
and the environment.
5.
Any downstream user shall identify, apply and where
suitable, recommend, appropriate measures to adequately
control risks identified in any of the following:

2. The information reported by the downstream user shall
include the following:(a) his identity and contact details as specified in Section 1.1 ofAnnex VI;(b) the registration number(s) referred to in Article 20(3), if
available;(c) the identity of the substance(s) as specified in Section 2.1 to
2.3.4 of Annex VI;(d) the identity of the manufacturer(s) or the importer(s) orother supplier as specified in Section 1.1 of Annex VI;(e) a brief general description of the use(s), as specified in
Section 3.5 of Annex VI, and of the conditions of use(s);(a) the safety data sheet(s) supplied to him;(b) his own chemical safety assessment;(c) any information on risk management measures supplied tohim in accordance with Article 32.
6.
Where a downstream user does not prepare a chemicalsafety report in accordance with paragraph 4(c), he shallconsider the use(s) of the substance and identify and apply any
appropriate risk management measures needed to ensure thatthe risks to human health and the environment are adequately
controlled. Where necessary, this information shall be included
in any safety data sheet prepared by him.

7.
Downstream users shall keep their chemical safety report
up to date and available.

8.
A chemical safety report prepared in accordance withparagraph 4 of this Article need not include consideration of
the risks to human health from the end uses set out in
Article 14(5).

(f) except where the downstream user is relying on the exemption in Article 37(4)(c), a proposal for additional testing onvertebrate animals, where this is considered necessary by thedownstream user to complete his chemical safety assessment.
3. The downstream user shall update this information
without delay in the event of a change in the information
reported in accordance with paragraph 1.
4. A downstream user shall report to the Agency if his classification of a substance is different to that of his supplier.
5. Except where a downstream user is relying on the exemption in Article 37(4)(c), reporting in accordance with paragraphs 1 to 4 of this Article shall not be required in respect of a
substance, on its own or in a preparation, used by the downstream user in quantities of less than one tonne per year forthat particular use.

Article 39
Application of downstream user obligations
Article 38

Obligation for downstream users to report information

1.
Before commencing or continuing with a particular use of
a substance that has been registered by an actor up the supply
chain in accordance with Articles 6 or 18, the downstream user
shall report to the Agency the information specified in paragraph 2 of this Article, in the following cases:

1. Downstream users shall be required to comply with therequirements of Article 37 at the latest 12 months after
receiving a registration number communicated to them by their
suppliers in a safety data sheet.
2. Downstream users shall be required to comply with therequirements of Article 38 at the latest six months after
receiving a registration number communicated to them by their
suppliers in a safety data sheet.

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TITLE VIEVALUATIONCHAPTER 1

L 136/39(e) a decision in accordance with points (a), (b) or (c), if several
registrants or downstream users of the same substance havesubmitted proposals for the same test, giving them theopportunity to reach an agreement on who will perform thetest on behalf of all of them and to inform the Agency
accordingly within 90 days. If the Agency is not informedof such agreement within such 90 days, it shall designate
one of the registrants or downstream users, as appropriate,
to perform the test on behalf of all of them.

Dossier evaluation
4. The registrant or downstream user shall submit the information required to the Agency by the deadline set.

Article 40

Examination of testing proposals

Article 41

1.
The Agency shall examine any testing proposal set out ina registration or a downstream user report for provision of theinformation specified in Annexes IX and X for a substance.
Priority shall be given to registrations of substances which haveor may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substancesclassified as dangerous according to Directive 67/548/EEC above
100 tonnes per year with uses resulting in widespread anddiffuse exposure.

Compliance check of registrations

2.
Information relating to testing proposals involving tests
on vertebrate animals shall be published on the Agency website.
The Agency shall publish on its website the name of thesubstance, the hazard end-point for which vertebrate testing is
proposed, and the date by which any third party information isrequired. It shall invite third parties to submit, using the format
provided by the Agency, scientifically valid information andstudies that address the relevant substance and hazard endpoint, addressed by the testing proposal, within 45 days of thedate of publication. All such scientifically valid information andstudies received shall be taken into account by the Agency inpreparing its decision in accordance with paragraph 3.

3.
On the basis of the examination under paragraph 1, theAgency shall draft one of the following decisions and that decision shall be taken in accordance with the procedure laid downin Articles 50 and 51:(a) a decision requiring the registrant(s) or downstream user(s)concerned to carry out the proposed test and setting a deadline for submission of the study summary, or the robust
study summary if required by Annex I;(b) a decision in accordance with point (a), but modifying theconditions under which the test is to be carried out;(c) a decision in accordance with points (a), (b) or (d) but
requiring registrant(s) or downstream user(s) to carry out
one or more additional tests in cases of non-compliance ofthe testing proposal with Annexes IX, X and XI;(d) a decision rejecting the testing proposal;

1. The Agency may examine any registration in order toverify any of the following:(a) that the information in the technical dossier(s) submitted
pursuant to Article 10 complies with the requirements ofArticles 10, 12 and 13 and with Annexes III and VI to X;(b) that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the generalrules set out in Annex XI;(c) that any required chemical safety assessment and chemicalsafety report comply with the requirements of Annex I andthat the proposed risk management measures are adequate;(d) that any explanation(s) submitted in accordance with
Article 11(3) or Article 19(2) have an objective basis.
2. The list of dossiers being checked for compliance by the
Agency shall be made available to Member States competentauthorities.

3. On the basis of an examination made pursuant to paragraph 1, the Agency may, within 12 months of the start of thecompliance check, prepare a draft decision requiring the registrant(s) to submit any information needed to bring the registration(s) into compliance with the relevant information requirements and specifying adequate time limits for the submission offurther information. Such a decision shall be taken in accordance with the procedure laid down in Articles 50 and 51.

4. The registrant shall submit the information required to the
Agency by the deadline set.

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5.
To ensure that registration dossiers comply with this Regulation, the Agency shall select a percentage of those dossiers, nolower than 5 % of the total received by the Agency for eachtonnage band, for compliance checking. The Agency shall givepriority, but not exclusively, to dossiers meeting at least one of
the following criteria:

29.5.2007
Article 43

Procedure and time periods for examination of testing
proposals(a) the dossier contains information in Article 10(a)(iv), (vi)and/or (vii) submitted separately as per Article 11(3); or

1. In the case of non phase-in substances, the Agency shallprepare a draft decision in accordance with Article 40(3) within
180 days of receiving a registration or downstream user reportcontaining a testing proposal.

(b) the dossier is for a substance manufactured or imported inquantities of one tonne or more per year and does not meetthe requirements of Annex VII applying under either
Article 12(1)(a) or (b), as the case may be; or

2. In the case of phase-in substances, the Agency shallprepare the draft decisions in accordance with Article 40(3):(c) the dossier is for a substance listed in the Community
rolling action plan referred to in Article 44(2).

6.
Any third party may electronically submit information to
the Agency relating to substances that appear on the list referred
to in Article 28(4). The Agency shall consider this information
together with the information submitted according to
Article 124 when checking and selecting dossiers.

7.
The Commission may, after consulting with the Agency,
take a decision to vary the percentage of dossiers selected andamend or include further criteria in paragraph 5 in accordancewith the procedure referred to in Article 133(4).

(a) by 1 December 2012 for all registrations received by
1 December 2010 containing proposals for testing in orderto fulfil the information requirements in Annexes IX and X;(b) by 1 June 2016 for all registrations received by 1 June 2013containing proposals for testing in order to fulfil the information requirements in Annex IX only;(c) by 1 June 2022 for any registrations containing testing
proposals received by 1 June 2018.
3. The list of registration dossiers being evaluated under
Article 40 shall be made available to Member States.

CHAPTER 2

Substance evaluation

Article 42

Check of information submitted and follow-up to dossier
evaluation

1.
The Agency shall examine any information submitted inconsequence of a decision taken under Articles 40 or 41, anddraft any appropriate decisions in accordance with these Articles, if necessary.

2.
Once the dossier evaluation is completed, the Agency shallnotify the Commission and the competent authorities of theMember States of the information obtained and any conclusions
made. The competent authorities shall use the information
obtained from this evaluation for the purposes of Article 45(5),Article 59(3) and Article 69(4). The Agency shall use the information obtained from this evaluation for the purposes of
Article 44.

Article 44

Criteria for substance evaluation

1. In order to ensure a harmonised approach, the Agency
shall in cooperation with the Member States develop criteria forprioritising substances with a view to further evaluation. Prioritisation shall be on a risk-based approach. The criteria shallconsider:(a) hazard information, for instance structural similarity of thesubstance with known substances of concern or with
substances which are persistent and liable to bio-accumulate,suggesting that the substance or one or more of its transformation products has properties of concern or is persistentand liable to bio-accumulate;(b) exposure information;(c) tonnage, including aggregated tonnage from the registrations
submitted by several registrants.

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2.
The Agency shall use the criteria in paragraph 1 for the
purpose of compiling a draft Community rolling action plan
which shall cover a period of three years and shall specify
substances to be evaluated each year. Substances shall be
included if there are grounds for considering (either on the basisof a dossier evaluation carried out by the Agency or on thebasis of any other appropriate source, including information in
the registration dossier) that a given substance constitutes a risk
to human health or the environment. The Agency shall submit
the first draft rolling action plan to the Member States by
1 December 2011. The Agency shall submit draft annual
updates to the rolling action plan to the Member States by 28
February each year.

The Agency shall adopt the final Community rolling action planon the basis of an opinion from the Member State Committee
set up under Article 76(1)(e) (hereinafter referred to as theMember State Committee) and shall publish the plan on its
website, identifying the Member State who will carry out theevaluation of the substances listed therein as determinedaccording to Article 45.

L 136/41

If, within 60 days of the referral, the Member State Committee
reaches unanimous agreement, the Member States concerned
shall adopt substances for evaluation accordingly.

If the Member State Committee fails to reach a unanimous
agreement, the Agency shall submit the conflicting opinions to
the Commission, which shall decide which authority shall be
the competent authority, in accordance with the procedurereferred to in Article 133(3), and the Member States concerned
shall adopt substances for evaluation accordingly.

4. The competent authority identified in accordance withparagraphs 2 and 3 shall evaluate the allocated substances inaccordance with this Chapter.

5. A Member State may notify the Agency at any time of a
substance not on the Community rolling action plan, whenever
it is in possession of information which suggests that thesubstance is a priority for evaluation. The Agency shall decide
whether to add this substance to the Community rolling action
plan on the basis of an opinion from the Member State
Committee. If the substance is added to the Community rolling
action plan, the proposing Member State, or another Member
State who agrees, shall evaluate that substance.

Article 45

Competent authority

1.
The Agency shall be responsible for coordinating thesubstance evaluation process and ensuring that substances on
the Community rolling action plan are evaluated. In doing so,
the Agency shall rely on the competent authorities of Member
States. In carrying out an evaluation of a substance, the competent authorities may appoint another body to act on theirbehalf.

2.
A Member State may choose (a) substance(s) from thedraft Community rolling action plan, with the aim of becoming
a competent authority for the purposes of Articles 46, 47 and48. In the event of a substance from the draft Community
rolling action plan not being chosen by any Member State, theAgency shall ensure that the substance is evaluated.

3.
In cases where two or more Member States have expressed
an interest in evaluating the same substance and they cannot
agree who should be the competent authority, the competentauthority for the purposes of Articles 46, 47 and 48 shall be
determined in accordance with the following procedure.

The Agency shall refer the matter to the Member State
Committee, in order to agree which authority shall be thecompetent authority, taking into account the Member State inwhich the manufacturer(s) or importer(s) is located, the respective proportions of total Community gross domestic product,
the number of substances already being evaluated by a Member
State and the expertise available.

Article 46

Requests for further information and check of information
submitted

1. If the competent authority considers that further information is required, including, if appropriate, information not
required in Annexes VII to X, it shall prepare a draft decision,
stating reasons, requiring the registrant(s) to submit the further
information and setting a deadline for its submission. A draft
decision shall be prepared within 12 months of the publicationof the Community rolling action plan on the Agency's website
for substances to be evaluated that year. The decision shall betaken in accordance with the procedure laid down in Articles 50
and 52.

2. The registrant shall submit the information required to the
Agency by the deadline set.

3. The competent authority shall examine any information
submitted, and shall draft any appropriate decisions in accordance with this Article, if necessary, within 12 months of theinformation being submitted.

4. The competent authority shall finish its evaluation activities within 12 months of the start of the evaluation of thesubstance or within 12 months of the information being
submitted under paragraph 2, and notify the Agency accordingly. If this deadline is exceeded, the evaluation shall bedeemed to be finished.

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Article 47
Coherence with other activities
1.
An evaluation of a substance shall be based on all relevant
information submitted on that particular substance and on any
previous evaluation under this Title. Where information on
intrinsic properties of a substance has been generated by reference to structurally related substance(s), the evaluation may also
cover these related substances. In cases where a decision on an
evaluation has been previously taken in accordance with
Article 51 or Article 52, any draft decision requiring further
information under Article 46 may be justified only by a changeof circumstances or acquired knowledge.
2.
In order to ensure a harmonised approach to requests forfurther information, the Agency shall monitor draft decisions
under Article 46 and shall develop criteria and priorities. Where
appropriate, implementing measures shall be adopted in accordance with the procedure referred to in Article 133(3).

29.5.2007(b) examine any information submitted and, if necessary,
recommend any appropriate risk reduction measures toaddress the risks identified in relation to the site in question.
The procedure provided for in the first paragraph may be undertaken only by the competent authority referred to therein. The
competent authority shall inform the Agency of the results ofsuch an evaluation, which shall then inform the competentauthorities of the other Member States and make the results
available to them.

CHAPTER 4

Common provisions

Article 50

Article 48

Registrants' and downstream users' rights

Follow-up to substance evaluation
Once the substance evaluation has been completed, the competent authority shall consider how to use the information
obtained from this evaluation for the purposes of Article 59(3),Article 69(4) and Article 115(1). The competent authority shallinform the Agency of its conclusions as to whether or how to
use the information obtained. The Agency shall in turn informthe Commission, the registrant and the competent authorities ofthe other Member States.

1. The Agency shall notify any draft decision under Articles 40, 41 or 46 to the registrant(s) or downstream user(s)concerned, informing them of their right to comment within
30 days of receipt. If the concerned registrant(s) or downstreamuser(s) wish to comment, they shall provide their comments to
the Agency. The Agency in turn shall inform the competentauthority of the submission of the comments without delay.
The competent authority (for decisions taken under Article 46)
and the Agency (for decisions taken under Articles 40 and 41)
shall take any comments received into account and may amend
the draft decision accordingly.

CHAPTER 3

Evaluation of intermediates

Article 49
Further information on on-site isolated intermediates
For on-site isolated intermediates that are used in strictly
controlled conditions, neither dossier nor substance evaluation
shall apply. However, where the competent authority of theMember State in whose territory the site is located considers
that a risk to human health or the environment, equivalent to
the level of concern arising from the use of substances meetingthe criteria in Article 57, arises from the use of an on-site
isolated intermediate and that risk is not properly controlled, itmay:(a) require the registrant to submit further information directly
related to the risk identified. This request shall be accompanied by a written justification;

2. If a registrant has ceased the manufacture or import of thesubstance, or the production or import of an article, or thedownstream user the use, he shall inform the Agency of thisfact with the consequence that the registered volume in his
registration, if appropriate, shall be put to zero and no further
information may be requested with respect to that substance,
unless the registrant notifies the restart of the manufacture or
import of the substance or the production or import of thearticle, or the downstream user notifies the restart of the use.
The Agency shall inform the competent authority of theMember State in which the registrant or downstream user islocated.

3. The registrant may cease the manufacture or import of thesubstance or the production or import of the article, or thedownstream user the use, upon receipt of the draft decision. In
such cases, the registrant, or downstream user, shall inform the
Agency of this fact with the consequence that his registration,or report, shall no longer be valid, and no further information
may be requested with respect to that substance, unless hesubmits a new registration or report. The Agency shall informthe competent authority of the Member State in which the registrant or downstream user is located.

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4.
Notwithstanding paragraphs 2 and 3, further information
may be required in accordance with Article 46 in either or bothof the following cases:(a) where the competent authority prepares a dossier in accordance with Annex XV concluding that there is a potential
long-term risk to human health or the environment justifying the need for further information;

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Article 52

Adoption of decisions under substance evaluation
1. The competent authority shall circulate its draft decisionin accordance with Article 46, together with any comments by
the registrant or downstream user, to the Agency and to thecompetent authorities of the other Member States.

(b) where the exposure to the substance manufactured orimported by the registrant(s), or to the substance in thearticle produced or imported by the registrant(s), or to thesubstance used by the downstream user(s) contributes significantly to that risk.

2. The provisions of Article 51(2) to (8) shall apply mutatis
mutandis.

The procedure in Articles 69 to 73 shall apply mutatis mutandis.

Article 53
Cost sharing for tests without an agreement between registrants and/or downstream users

Article 51
Adoption of decisions under dossier evaluation
1.
The Agency shall notify its draft decision in accordancewith Articles 40 or 41, together with the comments of theregistrant, to the competent authorities of the Member States.
2.
Within 30 days of circulation, the Member States may
propose amendments to the draft decision to the Agency.
3.
If the Agency does not receive any proposals, it shall takethe decision in the version notified under paragraph 1.
4.
If the Agency receives a proposal for amendment, it may
modify the draft decision. The Agency shall refer a draft decision, together with any amendments proposed, to the Member
State Committee within 15 days of the end of the 30-day
period referred to in paragraph 2.
5.
The Agency shall forthwith communicate any proposal for
amendment to any registrants or downstream users concernedand allow them to comment within 30 days. The Member State
Committee shall take any comments received into account.
6.
If, within 60 days of the referral, the Member State
Committee reaches a unanimous agreement on the draft decision, the Agency shall take the decision accordingly.
7.
If the Member State Committee fails to reach unanimous
agreement, the Commission shall prepare a draft decision to betaken in accordance with the procedure referred to in
Article 133(3).
8.
An appeal may be brought, in accordance with Articles 91,
92 and 93, against Agency decisions under paragraphs 3 and 6of this Article.

1. Where registrants or downstream users are required toperform a test as a result of a decision taken under this Title,
those registrants or downstream users shall make every effort toreach an agreement as to who is to carry it out on behalf of theother registrants or downstream users and to inform the
Agency accordingly within 90 days. If the Agency is not
informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users to perform thetest on behalf of all of them.
2. If a registrant or downstream user performs a test on
behalf of others, they shall all share the cost of that study
equally.
3. In the case referred to in paragraph 1, the registrant or
downstream user who performs the test shall provide each of
the others concerned with a copy of the full study report.
4. The person performing and submitting the study shallhave a claim against the others accordingly. Any person
concerned shall be able to make a claim in order to prohibit
another person from manufacturing, importing or placing thesubstance on the market if that other person either fails to pay
his share of the cost or to provide security for that amount or
fails to hand over a copy of the full study report of the study
performed. All claims shall be enforceable in the national
courts. Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration
order.

Article 54
Publication of information on evaluation
By 28 February of each year, the Agency shall publish on its
website a report on the progress made over the previous
calendar year towards discharging the obligations incumbent
upon it in relation to evaluation. This report shall include, inparticular, recommendations to potential registrants in order toimprove the quality of future registrations.

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TITLE VII

29.5.2007(e) in cases where the substance is placed on the market,
authorisation for that use has been granted to his immediate
downstream user.

AUTHORISATIONCHAPTER 1

2. A downstream user may use a substance meeting thecriteria set out in paragraph 1 provided that the use is in accordance with the conditions of an authorisation granted to an actor
up his supply chain for that use.

Authorisation requirement

Article 55

Aim of authorisation and considerations for substitution

The aim of this Title is to ensure the good functioning of theinternal market while assuring that the risks from substances ofvery high concern are properly controlled and that thesesubstances are progressively replaced by suitable alternative
substances or technologies where these are economically andtechnically viable. To this end all manufacturers, importers anddownstream users applying for authorisations shall analyse theavailability of alternatives and consider their risks, and the technical and economic feasibility of substitution.

Article 56

General provisions

1.
A manufacturer, importer or downstream user shall notplace a substance on the market for a use or use it himself ifthat substance is included in Annex XIV, unless:(a) the use(s) of that substance on its own or in a preparationor the incorporation of the substance into an article forwhich the substance is placed on the market or for which
he uses the substance himself has been authorised in accordance with Articles 60 to 64; or(b) the use(s) of that substance on its own or in a preparationor the incorporation of the substance into an article forwhich the substance is placed on the market or for which
he uses the substance himself has been exempted from theauthorisation requirement in Annex XIV itself in accordancewith Article 58(2); or(c) the date referred to in Article 58(1)(c)(i) has not beenreached; or(d) the date referred to in Article 58(1)(c)(i) has been reachedand he made an application 18 months before that date but
a decision on the application for authorisation has not yet
been taken; or

3. Paragraphs 1 and 2 shall not apply to the use of
substances in scientific research and development. Annex XIV
shall specify if paragraphs 1 and 2 apply to product and process
orientated research and development as well as the maximum
quantity exempted.

4. Paragraphs 1 and 2 shall not apply to the following usesof substances:(a) uses in plant protection products within the scope of Directive 91/414/EEC;(b) uses in biocidal products within the scope of Directive 98/8/
EC;(c) use as motor fuels covered by Directive 98/70/EC of theEuropean Parliament and of the Council of 13 October
1998 relating to the quality of petrol and diesel fuels (1);(d) uses as fuel in mobile or fixed combustion plants of mineraloil products and use as fuels in closed systems.
5. In the case of substances that are subject to authorisation
only because they meet the criteria in Article 57(a), (b) or (c) or
because they are identified in accordance with Article 57(f) only
because of hazards to human health, paragraphs 1 and 2 of this
Article shall not apply to the following uses:(a) uses in cosmetic products within the scope of Directive 76/
768/EEC;(b) uses in food contact materials within the scope of Regulation (EC) No 1935/2004.
6. Paragraphs 1 and 2 shall not apply to the use of
substances when they are present in preparations:(a) for substances referred to in Article 57(d), (e) and (f), below
a concentration limit of 0,1 % weight by weight (w/w);(b) for all other substances, below the lowest of the concentration limits specified in Directive 1999/45/EC or in Annex I
to Directive 67/548/EEC which result in the classification of
the preparation as dangerous.
(1) OJ L 350, 28.12.1998, p. 58. Directive as amended by Regulation (EC)No 1882/2003.

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Article 57
Substances to be included in Annex XIV
The following substances may be included in Annex XIV inaccordance with the procedure laid down in Article 58:(a) substances meeting the criteria for classification as carcinogenic category 1 or 2 in accordance with Directive 67/548/
EEC;(b) substances meeting the criteria for classification as mutagenic category 1 or 2 in accordance with Directive 67/548/
EEC;(c) substances meeting the criteria for classification as toxic for
reproduction category 1 or 2 in accordance with Directive 67/548/EEC;(d) substances which are persistent, bioaccumulative and toxic
in accordance with the criteria set out in Annex XIII of thisRegulation;(e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII ofthis Regulation;(f) substances — such as those having endocrine disrupting
properties or those having persistent, bioaccumulative andtoxic properties or very persistent and very bioaccumulative
properties, which do not fulfil the criteria of points (d) or(e) — for which there is scientific evidence of probableserious effects to human health or the environment whichgive rise to an equivalent level of concern to those of othersubstances listed in points (a) to (e) and which are identified
on a case-by-case basis in accordance with the procedure set
out in Article 59.

L 136/45(ii) a date or dates at least 18 months before the sunset date(s) by which applications must be received if the applicant wishes to continue to use the substance or place iton the market for certain uses after the sunset date(s);these continued uses shall be allowed after the sunset
date until a decision on the application for authorisation
is taken;(d) review periods for certain uses, if appropriate;(e) uses or categories of uses exempted from the authorisation
requirement, if any, and conditions for such exemptions, ifany.
2. Uses or categories of uses may be exempted from theauthorisation requirement provided that, on the basis of theexisting specific Community legislation imposing minimum
requirements relating to the protection of human health or theenvironment for the use of the substance, the risk is properly
controlled. In the establishment of such exemptions, accountshall be taken, in particular, of the proportionality of risk tohuman health and the environment related to the nature of thesubstance, such as where the risk is modified by the physicalform.

3. Prior to a decision to include substances in Annex XIV,
the Agency shall, taking into account the opinion of theMember State Committee, recommend priority substances to be
included specifying for each substance the items set out in paragraph 1. Priority shall normally be given to substances with:(a) PBT or vPvB properties; or(b) wide dispersive use; or(c) high volumes.

Article 58
Inclusion of substances in Annex XIV
1.
Whenever a decision is taken to include in Annex XIV
substances referred to in Article 57, such a decision shall betaken in accordance with the procedure referred to in
Article 133(4). It shall specify for each substance:(a) the identity of the substance as specified in Section 2 ofAnnex VI;(b) the intrinsic property (properties) of the substance referred
to in Article 57;(c) transitional arrangements:(i) the date(s) from which the placing on the market andthe use of the substance shall be prohibited unless anauthorisation is granted (hereinafter referred to as thesunset date) which should take into account, whereappropriate, the production cycle specified for that use;

The number of substances included in Annex XIV and the dates
specified under paragraph 1 shall also take account of the Agency's capacity to handle applications in the time provided for.
The Agency shall make its first recommendation of priority
substances to be included in Annex XIV by 1 June 2009. The
Agency shall make further recommendations at least every
second year with a view to including further substances inAnnex XIV.

4. Before the Agency sends its recommendation to theCommission it shall make it publicly available on its website,
clearly indicating the date of publication, taking into account
Articles 118 and 119 on access to information. The Agency
shall invite all interested parties to submit comments within
three months of the date of publication, in particular on uses
which should be exempt from the authorisation requirement.

The Agency shall update its recommendation, taking into
account the comments received.

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5.
Subject to paragraph 6, after inclusion of a substance inAnnex XIV, this substance shall not be subjected to new restrictions under the procedure outlined in Title VIII covering therisks to human health or the environment from the use of thesubstance on its own, in a preparation or incorporation of a
substance in an article arising from the intrinsic properties
specified in Annex XIV.

6.
A substance listed in Annex XIV may be subjected to new
restrictions under the procedure outlined in Title VIII covering
the risks to human health or the environment from thepresence of the substance in (an) article(s).

7.
Substances for which all uses have been prohibited under
Title VIII or by other Community legislation shall not be
included in Annex XIV or shall be removed from it.

8.
Substances which as a result of new information nolonger meet the criteria of Article 57 shall be removed fromAnnex XIV in accordance with the procedure referred to in
Article 133(4).

Article 59

Identification of substances referred to in Article 57

1.
The procedure set out in paragraphs 2 to 10 of this
Article shall apply for the purpose of identifying substances
meeting the criteria referred to in Article 57 and establishing acandidate list for eventual inclusion in Annex XIV. The Agency
shall indicate, within this list, the substances that are on its
work programme according to Article 83(3)(e).

2.
The Commission may ask the Agency to prepare a dossierin accordance with relevant Sections of Annex XV for
substances which in its opinion meet the criteria set out in
Article 57. The dossier may be limited, if appropriate, to a reference to an entry in Annex I of Directive 67/548/EEC. The
Agency shall make this dossier available to the Member States.

3.
Any Member State may prepare a dossier in accordancewith Annex XV for substances which in its opinion meet thecriteria set out in Article 57 and forward it to the Agency. The
dossier may be limited, if appropriate, to a reference to an entry
in Annex I of Directive 67/548/EEC. The Agency shall makethis dossier available within 30 days of receipt to the otherMember States.

4.
The Agency shall publish on its website a notice that an
Annex XV dossier has been prepared for a substance. The
Agency shall invite all interested parties to submit comments
within a specified deadline to the Agency.

29.5.2007

5. Within 60 days of circulation, the other Member States or
the Agency may comment on the identification of the substancein relation to the criteria in Article 57 in the dossier to the
Agency.

6. If the Agency does not receive or make any comments, it
shall include this substance on the list referred to in paragraph 1.
The Agency may include this substance in its recommendations
under Article 58(3).

7. When comments are made or received, the Agency shallrefer the dossier to the Member State Committee within 15 daysof the end of the 60-day period referred to in paragraph 5.

8. If, within 30 days of the referral, the Member State
Committee reaches a unanimous agreement on the identification, the Agency shall include the substance in the list referred
to in paragraph 1. The Agency may include that substance in its
recommendations under Article 58(3).

9. If the Member State Committee fails to reach a unanimous
agreement, the Commission shall prepare a draft proposal on
the identification of the substance within three months ofreceipt of the opinion of the Member State Committee. A final
decision on the identification of the substance shall be taken inaccordance with the procedure referred to in Article 133(3).

10.
The Agency shall publish and update the list referred toin paragraph 1 on its website without delay after a decision on
inclusion of a substance has been taken.

CHAPTER 2

Granting of authorisations

Article 60

Granting of authorisations

1. The Commission shall be responsible for taking decisions
on applications for authorisations in accordance with this Title.

2. Without prejudice to paragraph 3, an authorisation shallbe granted if the risk to human health or the environment fromthe use of a substance arising from the intrinsic properties
specified in Annex XIV is adequately controlled in accordancewith Section 6.4 of Annex I and as documented in the applicant's chemical safety report, taking into account the opinion of
the Committee for Risk Assessment referred to in Article 64(4)(a). When granting the authorisation, and in any conditions
imposed therein, the Commission shall take into account alldischarges, emissions and losses, including risks arising fromdiffuse or dispersive uses, known at the time of the decision.

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The Commission shall not consider the risks to human healtharising from the use of a substance in a medical device regulatedby Council Directive 90/385/EEC of 20 June 1990 on theapproximation of the laws of the Member States relating toactive implantable medical devices (1), Council Directive 93/42/
EEC of 14 June 1993 concerning medical devices (2) or Directive 98/79/EC of the European Parliament and of the Council of
27 October 1998 on in vitro diagnostic medical devices (3).

3.

L 136/47

into account the appropriateness and effectiveness of risk
management measures;(b) the technical and economic feasibility of alternatives for theapplicant.
6. A use shall not be authorised if this would constitute a
relaxation of a restriction set out in Annex XVII.

Paragraph 2 shall not apply to:(a) substances meeting the criteria in Article 57(a), (b), (c) or (f)for which it is not possible to determine a threshold inaccordance with Section 6.4 of Annex I;(b) substances meeting the criteria in Article 57(d) or (e);(c) substances identified under Article 57(f) having persistent,
bioaccumulative and toxic properties or very persistent andvery bioaccumulative properties.
4.
If an authorisation cannot be granted under paragraph 2
or for substances listed in paragraph 3, an authorisation may
only be granted if it is shown that socio-economic benefits
outweigh the risk to human health or the environment arisingfrom the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken
after consideration of all of the following elements and taking
into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis referred
to in Article 64(4)(a) and (b):7. An authorisation shall be granted only if the application ismade in conformity with the requirements of Article 62.

8. Authorisations shall be subject to a time-limited review
without prejudice to any decision on a future review period andshall normally be subject to conditions, including monitoring.
The duration of the time-limited review for any authorisation
shall be determined on a case-by-case basis taking into accountall relevant information including the elements listed in paragraph 4(a) to (d), as appropriate.

9.

The authorisation shall specify:(a) the person(s) to whom the authorisation is granted;(b) the identity of the substance(s);(c) the use(s) for which the authorisation is granted;(d) any conditions under which the authorisation is granted;(a) the risk posed by the uses of the substance, including theappropriateness and effectiveness of the risk management
measures proposed;(b) the socio-economic benefits arising from its use and thesocio-economic implications of a refusal to authorise as
demonstrated by the applicant or other interested parties;(c) the analysis of the alternatives submitted by the applicant
under Article 62(4)(e) or any substitution plan submitted by
the applicant under Article 62(4)(f), and any third party
contributions submitted under Article 64(2);(d) available information on the risks to human health or theenvironment of any alternative substances or technologies.
5.
When assessing whether suitable alternative substances ortechnologies are available, all relevant aspects shall be taken into
account by the Commission, including:(a) whether the transfer to alternatives would result in reduced
overall risks to human health and the environment, taking(1) OJ L 189, 20.7.1990, p. 17. Directive as last amended by Regulation(EC) No 1882/2003.
(2) OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC)No 1882/2003.
(3) OJ L 331, 7.12.1998, p. 1. Directive as last amended by Regulation (EC)No 1882/2003.

(e) the time-limited review period;(f) any monitoring arrangement.
10.
Notwithstanding any conditions of an authorisation, theholder shall ensure that the exposure is reduced to as low a level
as is technically and practically possible.

Article 61

Review of authorisations

1. Authorisations granted in accordance with Article 60 shallbe regarded as valid until the Commission decides to amend orwithdraw the authorisation in the context of a review, provided
that the holder of the authorisation submits a review report at
least 18 months before the expiry of the time-limited review
period. Rather than re-submitting all elements of the original
application for the current authorisation, the holder of an
authorisation may submit only the number of the current
authorisation, subject to the second, third and fourth subparagraphs.

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A holder of an authorisation granted in accordance with
Article 60 shall submit an update of the analysis of alternatives
referred to in Article 62(4)(e), including information about any
relevant research and development activities by the applicant, if
appropriate, and any substitution plan submitted under
Article 62(4)(f). If the update of the analysis of alternatives
shows that there is a suitable alternative available taking into
account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by theapplicant. If the holder cannot demonstrate that the risk isadequately controlled, he shall also submit an update of thesocio-economic analysis contained in the original application.

If he can now demonstrate that the risk is adequately controlled,
he shall submit an update of the chemical safety report.

If any other elements of the original application have changed,
he shall also submit updates of these element(s).

29.5.2007

5. If the environmental objectives as referred to in Article 4(1) of Directive 2000/60/EC are not met, the authorisations
granted for the use of the substance concerned in the relevant
river basin may be reviewed.
6. If a use of a substance is subsequently prohibited or otherwise restricted in Regulation (EC) No 850/2004 of the European
Parliament and of the Council of 29 April 2004 on persistentorganic pollutants (1), the Commission shall withdraw theauthorisation for that use.

Article 62
Applications for authorisations
1. An application for an authorisation shall be made to the
Agency.

When any updated information is submitted in accordance withthis paragraph, any decision to amend or withdraw the authorisation in the context of the review shall be taken in accordancewith the procedure referred to in Article 64 applied mutatis
mutandis.

2.

Authorisations may be reviewed at any time if:(a) the circumstances of the original authorisation havechanged so as to affect the risk to human health or theenvironment, or the socio-economic impact; or(b) new information on possible substitutes becomes available.
The Commission shall set a reasonable deadline by which theholder(s) of the authorisation may submit further informationnecessary for the review and indicate by when it will take a decision in accordance with Article 64.

3.
In its review decision the Commission may, if circumstances have changed and taking into account the principle ofproportionality, amend or withdraw the authorisation, if under
the changed circumstances it would not have been granted or if
suitable alternatives in accordance with Article 60(5) become
available. In the latter case the Commission shall require theholder of the authorisation to present a substitution plan if he
has not already done so as part of his application or update.

In cases where there is a serious and immediate risk for humanhealth or the environment, the Commission may suspend theauthorisation pending the review, taking into account the principle of proportionality.

4.
If an environmental quality standard referred to in Directive 96/61/EC is not met, the authorisations granted for the useof the substance concerned may be reviewed.

2. Applications for authorisation may be made by the manufacturer(s), importer(s) and/or downstream user(s) of thesubstance. Applications may be made by one or several persons.
3. Applications may be made for one or several substances,that meet the definition of a group of substances in Section 1.5
of Annex XI, and for one or several uses. Applications may bemade for the applicant's own use(s) and/or for uses for which
he intends to place the substance on the market.
4. An application for authorisation shall include thefollowing information:(a) the identity of the substance(s), as referred to in Section 2 ofAnnex VI;(b) the name and contact details of the person or persons
making the application;(c) a request for authorisation, specifying for which use(s) the
authorisation is sought and covering the use of thesubstance in preparations and/or the incorporation of thesubstance in articles, where this is relevant;(d) unless already submitted as part of the registration, achemical safety report in accordance with Annex I covering
the risks to human health and/or the environment from theuse of the substance(s) arising from the intrinsic properties
specified in Annex XIV;(e) an analysis of the alternatives considering their risks and thetechnical and economic feasibility of substitution andincluding, if appropriate information about any relevant
research and development activities by the applicant;(1) OJ L 158, 30.4.2004, p. 7, corrected in OJ L 229, 29.6.2004, p. 5.
Regulation as amended by Council Regulation (EC) No 1195/2006 (OJ
L 217, 8.8.2006, p. 1).

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Article 64(f) where the analysis referred to in point (e) shows thatsuitable alternatives are available, taking into account theelements in Article 60(5), a substitution plan including atimetable for proposed actions by the applicant.

Procedure for authorisation decisions
5.

The application may include:(a) a socio-economic analysis conducted in accordance with
Annex XVI;(b) a justification for not considering risks to human health andthe environment arising either from:(i) emissions of a substance from an installation for which
a permit was granted in accordance with Directive
96/61/EC; or(ii) discharges of a substance from a point source governedby the requirement for prior regulation referred to in
Article 11(3)(g) of Directive 2000/60/EC and legislation
adopted under Article 16 of that Directive.
6.
The application shall not include the risks to humanhealth arising from the use of a substance in a medical device
regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC.

7.
An application for an authorisation shall be accompaniedby the fee required in accordance with Title IX.

1. The Agency shall acknowledge the date of receipt of theapplication. The Agency's Committees for Risk Assessment andSocio-economic Analysis shall give their draft opinions within
ten months of the date of receipt of the application.

2. The Agency shall make available on its web-site broad
information on uses, taking into account Articles 118 and 119
on access to information, for which applications have been
received and for reviews of authorisations, with a deadline bywhich information on alternative substances or technologies
may be submitted by interested third parties.

3. In preparing its opinion, each Committee referred to inparagraph 1 shall first check that the application includes all theinformation specified in Article 62 that is relevant to its remit.
If necessary, the Committees shall, in consultation with eachother, make a joint request to the applicant for additional information to bring the application into conformity with therequirements of Article 62. The Committee for Socio-economic
Analysis may, if it deems it necessary, require the applicant orrequest third parties to submit, within a specified time period,
additional information on possible alternative substances ortechnologies. Each Committee shall also take into account any
information submitted by third parties.

Article 634.
Subsequent applications for authorisation

1.
If an application has been made for a use of a substance, a
subsequent applicant may refer to the appropriate parts of theprevious application submitted in accordance with Article 62(4)(d), (e) and (f) and (5)(a), provided that the subsequent applicant
has permission from the previous applicant to refer to theseparts of the application.

2.
If an authorisation has been granted for a use of a
substance, a subsequent applicant may refer to the appropriate
parts of the previous application submitted in accordance with
Article 62(4)(d), (e) and (f) and (5)(a), provided that the subsequent applicant has permission from the holder of the authorisation to refer to these parts of the application.

3.
Before referring to any previous application in accordancewith paragraphs 1 and 2, the subsequent applicant shall update
the information of the original application as necessary.

The draft opinions shall include the following elements:(a) Committee for Risk Assessment: an assessment of the risk
to human health and/or the environment arising from theuse(s) of the substance, including the appropriateness andeffectiveness of the risk management measures as describedin the application and, if relevant, an assessment of the risks
arising from possible alternatives;(b) Committee for Socio-economic Analysis: an assessment of
the socio-economic factors and the availability, suitability
and technical feasibility of alternatives associated with theuse(s) of the substance as described in the application, when
an application is made in accordance with Article 62 and of
any third party contributions submitted under paragraph 2of this Article.

5. The Agency shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1. Within
one month of receipt of the draft opinion, the applicant may
provide written notice that he wishes to comment. The draft
opinion shall be deemed to have been received seven days after
the Agency has sent it.

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If the applicant does not wish to comment, the Agency shallsend these opinions to the Commission, the Member States andthe applicant, within 15 days of the end of the period within
which the applicant may comment or within 15 days of receipt
of notice from the applicant that he does not intend tocomment.
If the applicant wishes to comment, he shall send his written
argumentation to the Agency within two months of the receiptof the draft opinion. The Committees shall consider thecomments and adopt their final opinions within two months ofreceipt of the written argumentation, taking this argumentation
into account where appropriate. Within a further 15 days the
Agency shall send the opinions, with the written argumentation
attached, to the Commission, the Member States and the applicant.
6.
The Agency shall determine in accordance with Articles 118 and 119 which parts of its opinions and parts of any
attachments thereto should be made publicly available on its
website.
7.
In cases covered by Article 63(1), the Agency shall treat
the applications together, provided the deadlines for the first
application can be met.
8.
The Commission shall prepare a draft authorisation decision within three months of receipt of the opinions from the
Agency. A final decision granting or refusing the authorisation
shall be taken in accordance with the procedure referred to in
Article 133(3).
9.
Summaries of the Commission decisions, including theauthorisation number and the reasons for the decision, in particular where suitable alternatives exist, shall be published in the
Official Journal of the European Union and shall be madepublicly available in a database established and kept up to dateby the Agency.
10.
In cases covered by Article 63(2), the deadline set out inparagraph 1 of this Article shall be shortened to five months.
CHAPTER 3

Authorisations in the supply chain

29.5.2007

2. The Agency shall establish and keep up to date a registerof downstream users who have made a notification in accordance with paragraph 1. The Agency shall grant access to thisregister to the competent authorities of the Member States.
TITLE VIII
RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE
MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES,
PREPARATIONS AND ARTICLESCHAPTER 1

General issues

Article 67
General provisions
1. A substance on its own, in a preparation or in an article,
for which Annex XVII contains a restriction shall not be manufactured, placed on the market or used unless it complies withthe conditions of that restriction. This shall not apply to the
manufacture, placing on the market or use of a substance inscientific research and development. Annex XVII shall specify if
the restriction shall not apply to product and process orientatedresearch and development, as well as the maximum quantity
exempted.
2. Paragraph 1 shall not apply to the use of substances incosmetic products, as defined by Directive 76/768/EEC, withregard to restrictions addressing the risks to human healthwithin the scope of that Directive.
3. Until 1 June 2013, a Member State may maintain any
existing and more stringent restrictions in relation toAnnex XVII on the manufacture, placing on the market or useof a substance, provided that those restrictions have been notified according to the Treaty. The Commission shall compile andpublish an inventory of these restrictions by 1 June 2009.
CHAPTER 2

Article 65
Obligation of holders of authorisations
Holders of an authorisation, as well as downstream users
referred to in Article 56(2) including the substances in a
preparation, shall include the authorisation number on the label
before they place the substance or a preparation containing thesubstance on the market for an authorised use without prejudice
to Directive 67/548/EEC and Directive 1999/45/EC. This shallbe done without delay once the authorisation number has been
made publicly available in accordance with Article 64(9).
Article 66
Downstream users
1.
Downstream users using a substance in accordance with
Article 56(2) shall notify the Agency within three months of thefirst supply of the substance.

Restrictions process

Article 68
Introducing new and amending current restrictions
1. When there is an unacceptable risk to human health or
the environment, arising from the manufacture, use or placing
on the market of substances, which needs to be addressed on a
Community-wide basis, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4) byadopting new restrictions, or amending current restrictions in
Annex XVII, for the manufacture, use or placing on the market
of substances on their own, in preparations or in articles,
pursuant to the procedure set out in Articles 69 to 73. Anysuch decision shall take into account the socio-economic impactof the restriction, including the availability of alternatives.

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The first subparagraph shall not apply to the use of a substanceas an on-site isolated intermediate.

2.
For a substance on its own, in a preparation or in anarticle which meets the criteria for classification as carcinogenic,
mutagenic or toxic to reproduction, category 1 or 2, and could
be used by consumers and for which restrictions to consumer
use are proposed by the Commission, Annex XVII shall beamended in accordance with the procedure referred to in
Article 133(4). Articles 69 to 73 shall not apply.

Article 69

Preparation of a proposal

1.
If the Commission considers that the manufacture, placing
on the market or use of a substance on its own, in a preparation
or in an article poses a risk to human health or the environment that is not adequately controlled and needs to beaddressed, it shall ask the Agency to prepare a dossier which
conforms to the requirements of Annex XV.

2.
After the date referred to in Article 58(1)(c)(i) for a
substance listed in Annex XIV, the Agency shall consider
whether the use of that substance in articles poses a risk tohuman health or the environment that is not adequately
controlled. If the Agency considers that the risk is notadequately controlled, it shall prepare a dossier which conforms
to the requirements of Annex XV.

3.
Within 12 months of the receipt of the request from theCommission in paragraph 1 and if this dossier demonstrates
that action on a Community-wide basis is necessary, beyond
any measures already in place, the Agency shall suggest restrictions, in order to initiate the restrictions process.

4.
If a Member State considers that the manufacture, placing
on the market or use of a substance on its own, in a preparation
or in an article poses a risk to human health or the environment that is not adequately controlled and needs to beaddressed it shall notify the Agency that it proposes to prepare
a dossier which conforms to the requirements of the relevant
sections of Annex XV. If the substance is not on the list maintained by the Agency referred to in paragraph 5 of this Article,
the Member State shall prepare a dossier which conforms to therequirements of Annex XV within 12 months of the notification
to the Agency. If this dossier demonstrates that action on a
Community-wide basis is necessary, beyond any measuresalready in place, the Member State shall submit it to the Agency
in the format outlined in Annex XV, in order to initiate therestrictions process.

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The Agency or Member States shall refer to any dossier,chemical safety report or risk assessment submitted to the
Agency or Member State under this Regulation. The Agency orMember States shall also refer to any relevant risk assessment
submitted for the purposes of other Community Regulations or
Directives. To this end other bodies, such as agencies, establishedunder Community law and carrying out a similar task shallprovide information to the Agency or Member State concernedon request.

The Committee for Risk Assessment and the Committee forSocio-economic Analysis shall check whether the dossier
submitted conforms to the requirements of Annex XV. Within
30 days of receipt, the respective Committee shall inform the
Agency or the Member State suggesting restrictions, as towhether the dossier conforms. If the dossier does not conform,
the reasons shall be given to the Agency or the Member State inwriting within 45 days of receipt. The Agency or the Member
State shall bring the dossier into conformity within 60 days ofthe date of receipt of the reasons from the Committees, otherwise the procedure under this Chapter shall be terminated. The
Agency shall publish without delay the intention of theCommission or of a Member State to instigate a restriction
procedure for a substance and shall inform those who submitted
a registration for that substance.

5. The Agency shall maintain a list of substances for which a
dossier conforming to the requirements of Annex XV is plannedor underway by either the Agency or a Member State for the
purposes of a proposed restriction. If a substance is on the list,
no other such dossier shall be prepared. If it is proposed byeither a Member State or the Agency that an existing restriction
listed in Annex XVII should be re-examined a decision onwhether to do so shall be taken in accordance with the procedure referred to in Article 133(2) based on evidence presented
by the Member State or the Agency.

6. Without prejudice to Articles 118 and 119, the Agency
shall make publicly available on its website all dossiersconforming with Annex XV including the restrictions suggested
pursuant to paragraphs 3 and 4 of this Article without delay,
clearly indicating the date of publication. The Agency shallinvite all interested parties to submit individually or jointly
within six months of the date of publication:(a) comments on dossiers and the suggested restrictions;(b) a socio-economic analysis, or information which can contribute to one, of the suggested restrictions, examining theadvantages and drawbacks of the proposed restrictions. It
shall conform to the requirements in Annex XVI.

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Article 70

29.5.2007

2. Without prejudice to Articles 118 and 119 the Agency
shall publish the opinions of the two Committees on its website
without delay.

Agency opinion: Committee for Risk Assessment
Within nine months of the date of publication referred to in
Article 69(6), the Committee for Risk Assessment shall formulate an opinion as to whether the suggested restrictions areappropriate in reducing the risk to human health and/or theenvironment, based on its consideration of the relevant parts ofthe dossier. This opinion shall take account of the Member Statedossier or of the dossier prepared by the Agency at the requestof the Commission, and the views of interested parties referred
to in Article 69(6)(a).

Article 71

3. The Agency shall provide the Commission and/or Member
State on request with all documents and evidence submitted toor considered by it.

Article 73
Commission decision
1. If the conditions laid down in Article 68 are fulfilled, theCommission shall prepare a draft amendment to Annex XVII,
within three months of receipt of the opinion of the Committee
for Socio-economic Analysis or by the end of the deadline
established under Article 71 if that Committee does not form
an opinion, whichever is the earlier.

Agency opinion: Committee for Socio-economic Analysis
1.
Within 12 months of the date of publication referred toin Article 69(6), the Committee for Socio-economic Analysis
shall formulate an opinion on the suggested restrictions, basedon its consideration of the relevant parts of the dossier and thesocio-economic impact. It shall prepare a draft opinion on thesuggested restrictions and on the related socio-economic impact,taking account of the analyses or information according to
Article 69(6)(b), if there are any. The Agency shall publish thedraft opinion on its website without delay. The Agency shallinvite interested parties to give their comments on the draft
opinion no later than 60 days from the publication of that draft
opinion.

Where the draft amendment diverges from the original proposal
or if it does not take the opinions from the Agency into
account, the Commission shall annex a detailed explanation of
the reasons for the differences.
2. A final decision shall be taken in accordance with theprocedure referred to in Article 133(4). The Commission shallsend the draft amendment to the Member States at least 45 days
before voting.
TITLE IX
FEES AND CHARGES

2.
The Committee for Socio-economic Analysis shall without
delay adopt its opinion, taking into account where appropriate
further comments received by the deadline set. This opinion
shall take account of the comments and socio-economic
analyses of interested parties submitted under Article 69(6)(b)and under paragraph 1 of this Article.
3.
Where the opinion of the Committee for Risk Assessment
diverges significantly from the restrictions suggested, the Agency
may postpone the deadline for the opinion of the Committee
for Socio-economic Analysis by a maximum of 90 days.

Article 72

Article 74
Fees and charges
1. The fees that are required according to Article 6(4),Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2),Article 18(2), Article 19(3), Article 22(5), Article 62(7) and
Article 92(3) shall be specified in a Commission Regulation
adopted in accordance with the procedure referred to in
Article 133(3) by 1 June 2008.
2. A fee need not be paid for a registration of a substance ina quantity of between 1 and 10 tonnes where the registration
dossier contains the full information in Annex VII.

Submission of an opinion to the Commission
1.
The Agency shall submit to the Commission without delay
the opinions of the Committees for Risk Assessment and Socioeconomic Analysis on restrictions suggested for substances on
their own, in preparations or in articles. If one or both of theCommittees do not formulate an opinion by the deadline set in
Article 70 and Article 71(1) the Agency shall inform theCommission accordingly, stating the reasons.

3. The structure and amount of the fees referred to in paragraph 1 shall take account of the work required by this Regulation to be carried out by the Agency and the competentauthority and shall be fixed at such a level as to ensure that therevenue derived from them when combined with other sourcesof the Agency's revenue pursuant to Article 96(1) is sufficient tocover the cost of the services delivered. The fees set for registration shall take into account the work that may be done pursuant
to Title VI.

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any other questions that arise from the operation of thisRegulation relating to the socio-economic impact of possible
legislative action on substances;

In the case of Article 6(4), Article 7(1) and (5), Article 9(2),Article 11(4), Article 17(2) and Article 18(2), the structure andamount of fees shall take account of the tonnage range of thesubstance being registered.
In all cases, a reduced fee shall be set for SMEs.
In the case of Article 11(4), the structure and amount of fees
shall take into account whether information has been submitted
jointly or separately.
In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the workrequired by the Agency in assessing the justification.
4.
The Regulation referred to in paragraph 1 shall specify thecircumstances under which a proportion of the fees will betransferred to the relevant Member State competent authority.
5.
The Agency may collect charges for other services it
provides.
TITLE XAGENCY

Article 75
Establishment and review
1.
A European Chemicals Agency is established for the
purposes of managing and in some cases carrying out the technical, scientific and administrative aspects of this Regulation andto ensure consistency at Community level in relation to these
aspects.
2.

(e) a Member State Committee, which shall be responsible forresolving potential divergences of opinions on draft decisions proposed by the Agency or the Member States under
Title VI and proposals for identification of substances ofvery high concern to be subjected to the authorisation
procedure under Title VII;(f) a Forum for Exchange of Information on Enforcement (hereinafter referred to as the Forum) which shall coordinate a
network of Member States authorities responsible for enforcement of this Regulation;(g) a Secretariat, which shall work under the leadership of the
Executive Director and provide technical, scientific andadministrative support for the Committees and the Forumand ensure appropriate coordination between them. It shallalso undertake the work required of the Agency under theprocedures for pre-registration, registration and evaluation
as well as preparation of guidance, database maintenanceand information provision;(h) a Board of Appeal, which shall decide on appeals against
decisions taken by the Agency.
2. The Committees referred to in points (c), (d) and (e) of
paragraph 1 (hereinafter referred to as the Committees) and theForum may each establish working groups. For this purpose
they shall adopt, in accordance with their rules of procedure,
precise arrangements for delegating certain tasks to theseworking groups.
3. The Committees and the Forum may, if they consider it
appropriate, seek advice on important questions of a generalscientific or ethical nature from appropriate sources of expertise.

The Agency shall be subject to a review by 1 June 2012.

Article 77

Article 76
Composition1.

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The Agency shall comprise:(a) a Management Board, which shall exercise the responsibilities set out in Article 78;(b) an Executive Director, who shall exercise the responsibilities
set out in Article 83;

Tasks
1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific andtechnical advice on questions relating to chemicals which fallwithin its remit and which are referred to it in accordance withthe provisions of this Regulation.

(c) a Committee for Risk Assessment, which shall be responsible for preparing the opinion of the Agency on evaluations, applications for authorisation, proposals for restrictions and proposals for classification and labelling under
Title XI and any other questions that arise from the operation of this Regulation relating to risks to human health or
the environment;

2.

The Secretariat shall undertake the following tasks:(d) a Committee for Socio-economic Analysis, which shall be
responsible for preparing the opinion of the Agency on
applications for authorisation, proposals for restrictions, and(b) performing the tasks allotted to it under Title III;(a) performing the tasks allotted to it under Title II; including
facilitating the efficient registration of imported substances,in a way consistent with the Community's international
trading obligations towards third countries;(c) performing the tasks allotted to it under Title VI;

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29.5.2007(d) performing the tasks allotted to it under Title VIII;(o) provision of formats for submission of information to the
Agency.

(e) establishing and maintaining database(s) with informationon all registered substances, the classification and labellinginventory and the harmonised classification and labelling
list. It shall make the information identified in Article 119(1) and (2) in the database(s) publicly available, free ofcharge, over the Internet, except where a request madeunder Article 10(a)(xi) is considered justified. The Agency
shall make other information in the databases available on
request in accordance with Article 118;

3.

(f) making publicly available information as to which
substances are being, and have been evaluated within 90
days of receipt of the information at the Agency, in accordance with Article 119(1);(g) providing technical and scientific guidance and tools whereappropriate for the operation of this Regulation in particular to assist the development of chemical safety reports (inaccordance with Article 14, Article 31(1) and Article 37(4))
and application of Article 10(a)(viii), Article 11(3) and
Article 19(2) by industry and especially by SMEs; and technical and scientific guidance for the application of Article 7
by producers and importers of articles;(h) providing technical and scientific guidance on the operationof this Regulation for Member State competent authorities
and providing support to the helpdesks established by
Member States under Title XIII;(i) providing guidance to stakeholders including Member State
competent authorities on communication to the public of
information on the risks and safe use of substances, on
their own, in preparations or in articles;(j) providing advice and assistance to manufacturers andimporters registering a substance in accordance with
Article 12(1);The Committees shall undertake the following tasks:(a) performing the tasks allotted to them under Titles VI to XI;(b) at the Executive Director's request, providing technical andscientific support for steps to improve cooperation between
the Community, its Member States, international organisations and third countries on scientific and technical issues
relating to the safety of substances, as well as active participation in technical assistance and capacity building activities
on sound management of chemicals in developing countries;(c) at the Executive Director's request, drawing up an opinion
on any other aspects concerning the safety of substances on
their own, in preparations or in articles.
4.

The Forum shall undertake the following tasks:(a) spreading good practice and highlighting problems at Community level;(b) proposing, coordinating and evaluating harmonised enforcement projects and joint inspections;(c) coordinating exchange of inspectors;(d) identifying enforcement strategies, as well as best practice inenforcement;(e) developing working methods and tools of use to local
inspectors;(f) developing an electronic information exchange procedure;(g) liaising with industry, taking particular account of thespecific needs of SMEs, and other stakeholders, including
relevant international organisations, as necessary;(h) examining proposals for restrictions with a view to advisingon enforceability.

(k) preparing explanatory information on this Regulation forother stakeholders;
Article 78(l) at the Commission's request, providing technical and scientific support for steps to improve cooperation between theCommunity, its Member States, international organisations
and third countries on scientific and technical issues
relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing
countries;

Powers of the Management Board
The Management Board shall appoint the Executive Director
pursuant to Article 84 and an accounting officer in accordancewith Article 43 of Regulation (EC, Euratom) No 2343/2002.
It shall adopt:(m) keeping a Manual of Decisions and Opinions based on
conclusions from the Member State Committee regarding
interpretation and implementation of this Regulation;(a) by 30 April each year, the general report of the Agency forthe previous year;(n) notification of decisions taken by the Agency;(b) by 31 October each year the work programme of the
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Official Journal of the European UnionEN(c) the final budget of the Agency pursuant to Article 96 before
the beginning of the financial year, adjusting it, where necessary, according to the Community contribution and anyother revenue of the Agency;

2. The terms of office of the Chairman and the DeputyChairman shall be two years and shall expire when they cease to
be members of the Management Board. The term of office shallbe renewable once.

(d) a multiannual work programme, which shall be regularly
revised.
It shall adopt the internal rules and procedures of the Agency.
These rules shall be made public.
It shall perform its duties in relation to the Agency's budget
pursuant to Articles 96, 97 and 103.
It shall exercise disciplinary authority over the Executive
Director.
It shall adopt its rules of procedure.
It shall appoint the Chairman, the members and alternates of
the Board of Appeal in accordance with Article 89.
It shall appoint the members of the Agency committees as set
out in Article 85.
It shall forward annually any information relevant to theoutcome of the evaluation procedures in accordance with
Article 96(6).

Article 79
Composition of the Management Board
1.
The Management Board shall be composed of one representative from each Member State and a maximum of six representatives appointed by the Commission, including three individuals from interested parties without voting rights and in addition two independent persons appointed by the European Parliament.
Each Member State shall nominate a member to the Management Board. The members thus nominated shall be appointed
by the Council.
2.
Members shall be appointed on the basis of their relevant
experience and expertise in the field of chemical safety or the
regulation of chemicals whilst ensuring there is relevant expertise amongst the board members in the fields of general, financial and legal matters.

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Article 81
Meetings of the Management Board
1. The meetings of the Management Board shall be convened
by invitation of its Chairman or at the request of at least one
third of the Board members.
2. The Executive Director shall take part in the meetings ofthe Management Board, without voting rights.
3. The Chairmen of the Committees and the Chairman of
the Forum, as referred to in Article 76(1)(c) to (f), are entitled toattend the meetings of the Management Board without voting
rights.

Article 82
Voting of the Management Board
The Management Board shall adopt rules of procedure forvoting, including the conditions for a member to vote on behalfof another member. The Management Board shall act by a twothirds majority of all members with the right to vote.

Article 83
Duties and powers of the Executive Director
1. The Agency shall be managed by its Executive Director,
who shall perform his duties in the interests of the Community,
and independently of any specific interests.
2. The Executive Director shall be the legal representative of
the Agency. He shall be responsible for:(a) the day-to-day administration of the Agency;(b) managing all the Agency resources necessary for carryingout its tasks;(c) ensuring that the time-limits laid down in Community
legislation for the adoption of opinions by the Agency arecomplied with;3.
The duration of the term of office shall be four years. The
term of office may be renewed once. However, for the firstmandate, the Commission shall identify half of its appointees,
and the Council shall identify 12 of its appointees, for whom
this period shall be six years.

(d) ensuring appropriate and timely coordination between theCommittees and the Forum;

Article 80(e) concluding and managing necessary contracts with service
providers;

Chairmanship of the Management Board
1.
The Management Board shall elect a Chairman and a
Deputy-Chairman from among the members with voting rights.
The Deputy-Chairman shall automatically take the place of the
Chairman if he is prevented from attending to his duties.

(f) the preparation of the statement of revenue and expenditure and the implementation of the budget of the Agency
pursuant to Articles 96 and 97;(g) all staff matters;(h) providing the secretariat for the Management Board;L 136/56

Official Journal of the European UnionEN(i) preparing draft opinions of the Management Board
concerning the proposed rules of procedure of theCommittees and of the Forum;(j) making arrangements, upon request from the Management
Board, for the execution of any further function(s) (within
the remit of Article 77) allotted to the Agency by delegation from the Commission;(k) establishing and maintaining a regular dialogue with theEuropean Parliament;(l) determining the terms and conditions for use of software
packages;(m) rectifying a decision made by the Agency following anappeal and after consulting the Chairman of the Board of
Appeal.
3.
Each year, the Executive Director shall submit thefollowing to the Management Board for approval:(a) a draft report covering the activities of the Agency in theprevious year, including information about the number ofregistration dossiers received, the number of substances evaluated, the number of applications for authorisation received,
the number of proposals for restriction received by the
Agency and opined upon, the time taken for completion of
the associated procedures, and the substances authorised,dossiers rejected, substances restricted; complaints received
and the action taken; an overview of the activities of theForum;

29.5.2007

proposed by the Commission following a call for expressions ofinterest published in the Official Journal of the European Unionand in other periodicals or on Internet sites.

The Executive Director shall be appointed on the grounds of
merit and documented administrative and management skills, aswell as his relevant experience in the fields of chemical safety or
regulation. The Management Board shall take its decision by a
two-thirds majority of all members with a right to vote.

Power to dismiss the Executive Director shall lie with theManagement Board, in accordance with the same procedure.

Before being appointed, the candidate selected by the Management Board shall be invited as soon as possible to make a statement before the European Parliament and to answer questions
from Members of Parliament.

2. The term of the office of the Executive Director shall befive years. It may be prolonged by the Management Board once
for another period of up to five years.

Article 85(b) a draft work-programme for the coming year;(c) the draft annual accounts;

Establishment of the Committees(d) the draft forecast budget for the coming year;(e) a draft multiannual work programme.
The Executive Director shall, following approval by the Management Board, forward the work programme for the coming year
and the multiannual work programme to the Member States,
the European Parliament, the Council and the Commission, andshall have them published.
The Executive Director shall, following approval by the Management Board, forward the Agency's general report to the Member
States, the European Parliament, the Council, the Commission,
the European Economic and Social Committee and the Court of
Auditors, and shall have it published.

Article 84
Appointment of the Executive Director
1.
The Executive Director of the Agency shall be appointed
by the Management Board on the basis of a list of candidates

1. Each Member State may nominate candidates to membership of the Committee for Risk Assessment. The Executive
Director shall establish a list of the nominees, which shall be
published on the Agency's website, without prejudice to
Article 88(1). The Management Board shall appoint themembers of the Committee from this list, including at least one
member but not more than two from the nominees of each
Member State that has nominated candidates. Members shall be
appointed for their role and experience in performing the tasks
specified in Article 77(3).

2. Each Member State may nominate candidates to membership of the Committee for Socio-economic Analysis. The Executive Director shall establish a list of the nominees, which shallbe published on the Agency's website, without prejudice to
Article 88(1). The Management Board shall appoint themembers of the Committee from this list, including at least one
member but not more than two from the nominees of each
Member State that has nominated candidates. Members shall be
appointed for their role and experience in performing the tasks
specified in Article 77(3).

3. Each Member State shall appoint one member to theMember State Committee.

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4.
The Committees shall aim to have a broad range of relevant expertise among their members. To this end eachCommittee may co-opt a maximum of five additional members
chosen on the basis of their specific competence.

Members of the Committees shall be appointed for a term of
three years which shall be renewable.

The members of the Management Board may not be membersof the Committees.

The members of each Committee may be accompanied by advisers on scientific, technical or regulatory matters.

The Executive Director or his representative and representativesof the Commission shall be entitled to attend all the meetingsof the Committees and working groups convened by the
Agency or its committees as observers. Stakeholders may also
be invited to attend meetings as observers, as appropriate, at therequest of the Committee members, or the Management Board.

5.
The members of each Committee appointed following
nomination by a Member State shall ensure that there is appropriate coordination between the tasks of the Agency and thework of their Member State competent authority.

6.
The members of the Committees shall be supported by
the scientific and technical resources available to the Member
States. To this end, Member States shall provide adequate scientific and technical resources to the members of the Committees
that they have nominated. Each Member State competentauthority shall facilitate the activities of the Committees andtheir working groups.

7.
The Member States shall refrain from giving the membersof the Committee for Risk Assessment or of the Committee forSocio-Economic Analysis, or their scientific and technical advisers and experts, any instruction which is incompatible with theindividual tasks of those persons or with the tasks, responsibilities and independence of the Agency.

L 136/57

lishment of a procedure for the urgent adoption of opinions.
The Chairman of each Committee shall be an employee of the
Agency.

Article 86

Establishment of the Forum

1. Each Member State shall appoint, for a three-year term,
which shall be renewable, one member to the Forum. Members
shall be chosen for their role and experience in enforcement ofchemicals legislation and shall maintain relevant contacts with
the Member State competent authorities.

The Forum shall aim to have a broad range of relevant expertiseamong its members. To this end the Forum may co-opt a
maximum of five additional members chosen on the basis of
their specific competence. These members shall be appointed fora term of three years, which shall be renewable. Members of theManagement Board may not be members of the Forum.

The members of the Forum may be accompanied by scientificand technical advisers.

The Executive Director of the Agency or his representative andrepresentatives of the Commission shall be entitled to attend all
the meetings of the Forum and its working groups. Stakeholders
may also be invited to attend meetings as observers, as appropriate, at the request of Forum members, or the Management
Board.

2. The members of the Forum appointed by a Member State
shall ensure that there is appropriate coordination between thetasks of the Forum and the work of their Member State competent authority.

8.
When preparing an opinion, each Committee shall use its
best endeavours to reach a consensus. If such a consensus
cannot be reached, the opinion shall consist of the position of
the majority of members, including their grounds. The minority
position(s), including their grounds, shall also be published.

3. The members of the Forum shall be supported by thescientific and technical resources available to the competentauthorities of the Member States. Each Member State competentauthority shall facilitate the activities of the Forum and its
working groups. The Member States shall refrain from giving
the Forum members, or their scientific and technical advisersand experts any instruction which is incompatible with the individual tasks of those persons or with the tasks and responsibilities of the Forum.

9.
Each Committee shall draft a proposal for its own rules ofprocedure, to be approved by the Management Board, within six
months of the Committees first being appointed.

4. The Forum shall draft a proposal for its own rules ofprocedure, to be adopted by the Management Board, within six
months of the Forum first being appointed.

These rules shall in particular lay down the procedures for replacing members, the procedures for delegating certain tasks toworking groups, the creation of working groups and the estab-

These rules shall in particular lay down the procedures forappointing and replacing the Chairman, replacing members andthe procedures for delegating certain tasks to working groups.

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Article 87

Article 88

Rapporteurs of Committees and use of experts

Qualification and interests

1.
Where, in accordance with Article 77, a Committee isrequired to provide an opinion or consider whether a Member
State dossier conforms with the requirements of Annex XV, it
shall appoint one of its members as a rapporteur. The
Committee concerned may appoint a second member to act as
co-rapporteur. For each case, rapporteurs and co-rapporteurs
shall undertake to act in the interests of the Community andshall make a declaration of commitment to fulfil their duties
and a declaration of interests in writing. A member of aCommittee shall not be appointed rapporteur for a particularcase if he indicates any interest that might be prejudicial to the
independent consideration of that case. The Committee
concerned may replace the rapporteur or co-rapporteur byanother one of its members at any time, if, for example, they
are unable to fulfil their duties within the prescribed time limits,
or if a potentially prejudicial interest comes to light.
2.
Member States shall transmit to the Agency the names ofexperts with proven experience in the tasks required by
Article 77, who would be available to serve on working groupsof the Committees, together with an indication of their qualifications and specific areas of expertise.
The Agency shall keep an up-to-date list of experts. The list
shall include the experts referred to in the first subparagraphand other experts identified directly by the Secretariat.
3.
The provision of services by Committee members or any
expert serving on a working group of the Committees orForum, or performing any other task for the Agency shall begoverned by a written contract between the Agency and theperson concerned, or where appropriate between the Agency
and the employer of the person concerned.
The person concerned, or his employer, shall be remunerated by
the Agency in accordance with a scale of fees to be included in
the financial arrangements established by the Management
Board. Where the person concerned fails to fulfil his duties, theExecutive Director has the right to terminate or suspend thecontract or withhold remuneration.
4.
The provision of services for which there are several
potential providers may require a call for an expression ofinterest:(a) if the scientific and technical context allows; and(b) if it is compatible with the duties of the Agency, in particular the need to provide a high level of protection of humanhealth and the environment.

1. The membership of the Committees and of the Forumshall be made public. Individual members may request that theirnames not be made public if they believe that such publication
could place them at risk. The Executive Director shall decide
whether to agree to such requests. When each appointment ispublished, the professional qualifications of each member shallbe specified.
2. Members of the Management Board, the Executive
Director and members of the Committees and of the Forumshall make a declaration of commitment to fulfil their duties
and a declaration of interests which could be considered to be
prejudicial to their independence. These declarations shall bemade annually in writing and, without prejudice to paragraph 1,
be entered in a register held by the Agency which is accessible
to the public, on request, at the Agency's offices.
3. At each of their meetings, members of the Management
Board, the Executive Director, members of the Committees andof the Forum and any experts participating in the meeting shalldeclare any interests which could be considered to be prejudicial
to their independence with respect to any points on the agenda.
Anyone declaring such interests shall not participate in any
voting on the relevant agenda point.

Article 89
Establishment of the Board of Appeal
1. The Board of Appeal shall consist of a Chairman and twoother members.
2. The Chairman and the two members shall have alternates
who shall represent them in their absence.
3. The Chairman, the other members and the alternates shallbe appointed by the Management Board on the basis of a list of
candidates proposed by the Commission following a call for
expressions of interest published in the Official Journal of theEuropean Union and in other periodicals or on Internet sites.
They shall be appointed on the basis of their relevant experienceand expertise in the field of chemical safety, natural sciences orregulatory and judicial procedures from a list of qualified candidates adopted by the Commission.
The Management Board may appoint additional members andtheir alternates, on recommendation by the Executive Director,
following the same procedure, if this is necessary to ensure thatthe appeals can be processed at a satisfactory rate.

The Management Board shall adopt the appropriate procedures
on a proposal from the Executive Director.

4. The qualifications required for the members of the Boardof Appeal shall be determined by the Commission in accordancewith the procedure referred to in Article 133(3).

5.
The Agency may use the services of experts for thedischarge of other specific tasks for which it is responsible.

5. The Chairman and the members shall have equal voting
rights.

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Article 90

L 136/59

addressed to another person, is of direct and individual concern
to the former.

Members of the Board of Appeal
1.
The term of office of the members of the Board of
Appeal, including the Chairman and the alternates shall befive years. It may be prolonged once.
2.
The members of the Board of Appeal shall be independent. In making their decisions they shall not be bound by any
instructions.

2. The appeal, together with the statements of the grounds
thereof, shall be filed in writing to the Agency within threemonths of the notification of the decision to the person
concerned, or in the absence thereof, of the day on which it
became known to the latter, unless otherwise provided in thisRegulation.
3. A fee may be payable by persons bringing an appeal
against an Agency decision, in accordance with Title IX.

3.
The members of the Board of Appeal may not perform
any other duties in the Agency.
Article 93
4.
The members of the Board of Appeal may not be
removed either from office or from the list during their respective terms, unless there are serious grounds for such removal
and the Commission, after obtaining the opinion of theManagement Board, takes a decision to this effect.
5.
Members of the Board of Appeal may not take part in any
appeal proceedings if they have any personal interest therein, or
if they have previously been involved as representatives of oneof the parties to the proceedings, or if they participated in thedecision under appeal.
6.
If a member of the Board of Appeal considers for reasonsmentioned in paragraph 5 that he must not take part in a
specific appeal proceedings, he shall inform the Board of Appeal
accordingly. Members of the Board may be objected to by any
party to the appeal proceedings on any of the grounds
mentioned in paragraph 5, or if suspected of partiality. No
objection may be based on the nationality of members.
7.
The Board of Appeal shall decide as to the action to betaken in the cases specified in paragraphs 5 and 6 without theparticipation of the member concerned. For the purposes oftaking this decision, the member concerned shall be replaced on
the Board of Appeal by an alternate.

Examination and decisions on appeal
1. If, after consultation with the Chairman of the Board of
Appeal, the Executive Director considers the appeal to be admissible and well founded he may rectify the decision within
30 days of the appeal being filed in accordance with Article 92(2).
2. In cases other than those referred to in paragraph 1 ofthis Article, the Chairman of the Board of Appeal shall examine
whether the appeal is admissible within 30 days of the appeal
being filed in accordance with Article 92(2). In the affirmative,
the appeal shall be remitted to the Board of Appeal for examination of the grounds. Parties to the appeal proceedings shall beentitled to make an oral presentation during the procedure.
3. The Board of Appeal may exercise any power which lies
within the competence of the Agency or remit the case to thecompetent body of the Agency for further action.
4. The procedures for the Board of Appeal shall be determined by the Commission in accordance with the procedurereferred to in Article 133(3).

Article 91

Article 94

Decisions subject to appeal

Actions before the Court of First Instance and the Court ofJustice1.
An appeal may be brought against decisions of the
Agency taken pursuant to Article 9, Article 20, Article 27(6),Article 30(2) and (3) and Article 51.
2.
An appeal lodged pursuant to paragraph 1 shall havesuspensive effect.

Article 92

1. An action may be brought before the Court of First
Instance or the Court of Justice, in accordance with Article 230of the Treaty, contesting a decision taken by the Board of
Appeal or, in cases where no right of appeal lies before theBoard, by the Agency.
2. Should the Agency fail to take a decision, proceedings for
failure to act may be brought before the Court of First Instanceor the Court of Justice in accordance with Article 232 of theTreaty.

Persons entitled to appeal, time-limits, fees and form
1.
Any natural or legal person may appeal against a decision
addressed to that person, or against a decision which, although

3. The Agency shall be required to take the necessary
measures to comply with the judgment of the Court of First
Instance or the Court of Justice.

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Article 95
Conflicts of opinion with other bodies
1.
The Agency shall take care to ensure early identification ofpotential sources of conflict between its opinions and those ofother bodies established under Community law, including Community Agencies, carrying out a similar task in relation to issuesof common concern.
2.
Where the Agency identifies a potential source of conflict,it shall contact the body concerned in order to ensure that any
relevant scientific or technical information is shared and to identify the scientific or technical points which are potentiallycontentious.
3.
Where there is a fundamental conflict over scientific ortechnical points and the body concerned is a Community
Agency or a scientific committee, the Agency and the bodyconcerned shall work together either to solve the conflict or to
submit a joint document to the Commission clarifying thescientific and/or technical points of conflict.

Article 96
The budget of the Agency
1.

The revenues of the Agency shall consist of:(a) a subsidy from the Community, entered in the generalbudget of the European Communities (Commission
Section);29.5.2007

7. On the basis of the estimate, the Commission shall enterin the preliminary draft budget of the European Communities
the estimates it considers necessary for the establishment planand the amount of the subsidy to be charged to the generalbudget, which it shall place before the budgetary authority inaccordance with Article 272 of the Treaty.
8. The budgetary authority shall authorise the appropriations
for the subsidy to the Agency.
The budgetary authority shall adopt the establishment plan for
the Agency.
9. The budget of the Agency shall be adopted by the Management Board. It shall become final following final adoption of
the general budget of the European Communities. Where appropriate, it shall be adjusted accordingly.
10.
Any modification to the budget, including the establishment plan, shall follow the procedure referred to above.
11.
The Management Board shall, without delay, notify thebudgetary authority of its intention to implement any project
which may have significant financial implications for thefunding of its budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall informthe Commission thereof.
Where a branch of the budgetary authority has notified its
intention to deliver an opinion, it shall forward its opinion to
the Management Board within a period of six weeks from thedate of notification of the project.

(b) the fees paid by undertakings;(c) any voluntary contribution from the Member States.
2.
The expenditure of the Agency shall include the staff,
administrative, infrastructure and operational expenses.
3.
By 15 February of each year at the latest, the Executive
Director shall draw up a preliminary draft budget covering theoperational expenditure and the programme of work anticipated
for the following financial year, and shall forward this preliminary draft to the Management Board together with an establishment plan accompanied by a provisional list of posts.
4.

Article 97
Implementation of the budget of the Agency
1. The Executive Director shall perform the duties of authorising officer and shall implement the Agency's budget.
2. Monitoring of the commitment and payment of all the
Agency's expenditure and of the establishment and recovery of
all the Agency's revenue shall be carried out by the Accounting
Officer of the Agency.

Revenue and expenditure shall be in balance.

5.
Each year the Management Board, on the basis of a draft
drawn up by the Executive Director, shall produce an estimateof revenue and expenditure for the Agency for the following
financial year. This estimate, which shall include a draft establishment plan, shall be forwarded by the Management Board to
the Commission by 31 March at the latest.
6.
The estimate shall be forwarded by the Commission to theEuropean Parliament and the Council (hereinafter referred to as
the budgetary authority) together with the preliminary draft
budget of the European Communities.

3. By 1 March at the latest following each financial year, theAgency's accounting officer shall communicate the provisional
accounts to the Commission's accounting officer together witha report on the budgetary and financial management for that
financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the
Financial Regulation applicable to the general budget of theEuropean Communities (1).
(1) OJ L 248, 16.9.2002, p. 1. Regulation as amended by Regulation (EC,
Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p. 1).

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4.
By 31 March at the latest following each financial year, theCommission's accounting officer shall forward the Agency's
provisional accounts to the Court of Auditors, together with areport on the budgetary and financial management for that
financial year. The report on the budgetary and financial
management for that financial year shall also be forwarded to
the European Parliament and the Council.

3. The decisions concerning funding and the implementing
agreements and instruments resulting from them shall explicitly
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.

5.
On receipt of the Court of Auditors' observations on the
Agency's provisional accounts, pursuant to Article 129 of Regulation (EC, Euratom) No 1605/2002, the Executive Director
shall draw up the Agency's final accounts under his own responsibility and forward them to the Management Board for an
opinion.

Article 99

6.
The Management Board shall deliver an opinion on the
Agency's final accounts.

Financial rules
The financial rules applicable to the Agency shall be adopted by
the Management Board after the Commission has been
consulted. They may not depart from Regulation (EC, Euratom)
No 2343/2002 unless specifically necessary for the Agency's
operation and with the Commission's prior consent.

7.
By 1 July of the following year at the latest, the Executive
Director shall send the final accounts, together with the opinionof the Management Board, to the European Parliament, theCouncil, the Commission and the Court of Auditors.
8.

Article 100
Legal personality of the Agency

The final accounts shall be published.

9.
The Executive Director shall send the Court of Auditors a
reply to its observations by 30 September at the latest. He shallalso send this reply to the Management Board.
10.
The European Parliament, upon a recommendation fromthe Council, shall, before 30 April of year N + 2, give adischarge to the Executive Director in respect of the implementation of the budget for year N.

Article 98
Combating fraud
1.
In order to combat fraud, corruption and other unlawful
activities, the provisions of Regulation (EC) No 1073/1999 of
the European Parliament and of the Council of 25 May 1999
concerning investigations conducted by the European AntiFraud Office (OLAF) (1) shall apply without restrictions to the
Agency.
2.
The Agency shall be bound by the Interinstitutional Agreement of 25 May 1999 between the European Parliament, theCouncil of the European Union and the Commission of theEuropean Communities concerning internal investigations by
the European Anti-Fraud Office (OLAF) (2) and shall issue,
without delay, the appropriate provisions applicable to all of its
staff.
(1) OJ L 136, 31.5.1999, p. 1.
(2) OJ L 136, 31.5.1999, p. 15.

1. The Agency shall be a body of the Community and shallhave legal personality. In each Member State it shall enjoy themost extensive legal capacity accorded to legal persons under
their laws. In particular it may acquire and dispose of movableand immovable property and may be a party to legal proceedings.
2.

The Agency shall be represented by its Executive Director.

Article 101
Liability of the Agency
1. The contractual liability of the Agency shall be governedby the law applicable to the contract in question. The Court ofJustice shall have jurisdiction pursuant to any arbitration clausecontained in a contract concluded by the Agency.
2. In the case of non-contractual liability, the Agency shall,in accordance with the general principles common to the lawsof the Member States, make good any damage caused by it orby its servants in the performance of their duties.
The Court of Justice shall have jurisdiction in any dispute
relating to compensation for such damages.
3. The personal financial and disciplinary liability of its
servants towards the Agency shall be governed by the relevant
rules applying to the staff of the Agency.

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Article 102

Article 107

Privileges and immunities of the Agency

Participation of international organisations

The Protocol on the Privileges and Immunities of the European
Communities shall apply to the Agency.

The Management Board may, in agreement with the relevantCommittee or the Forum, invite representatives of internationalorganisations with interests in the field of chemicals regulation
to participate as observers in the work of the Agency.

Article 103
Staff rules and regulations
1.
The staff of the Agency shall be subject to the Regulations
and Rules applicable to officials and other servants of the European Communities. In respect of its staff, the Agency shall exercise the powers which have been devolved to the appointing
authority.
2.
The Management Board shall, in agreement with theCommission, adopt the necessary implementing provisions.
3.
The Agency's staff shall consist of officials assigned or
seconded by the Commission or Member States on a temporary
basis and of other servants recruited by the Agency as necessary
to carry out its tasks. The Agency shall recruit its personnel on
the basis of a staffing plan to be included in the multiannual
work programme referred to in Article 78(d).

Article 104
Languages
1.
Regulation No 1 of 15 April 1958 determining thelanguages to be used in the European Economic Community (1)shall apply to the Agency.
2.
The translation services required for the functioning of the
Agency shall be provided by the Translation Centre of thebodies of the European Union.

Article 108
Contacts with stakeholder organisations
The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and relevant stakeholder organisations.

Article 109
Rules on transparency
To ensure transparency, the Management Board shall, on thebasis of a proposal by the Executive Director and in agreementwith the Commission, adopt rules to ensure the availability tothe public of regulatory, scientific or technical information
concerning the safety of substances on their own, in preparations or in articles which is not of a confidential nature.

Article 110
Relations with relevant Community bodies
1. The Agency shall cooperate with other Community bodies
to ensure mutual support in the accomplishment of theirrespective tasks in particular to avoid duplication of work.

Article 105
Duty of confidentiality
Members of the Management Board, members of the Committees and of the Forum, experts and officials and other servantsof the Agency, shall be required, even after their duties haveceased, not to disclose information of the kind covered by the
duty of professional secrecy.

Article 106

2. The Executive Director, having consulted the Committee
on Risk Assessment and the European Food Safety Authority,
shall establish rules of procedure concerning substances forwhich an opinion has been sought in a food safety context.
These rules of procedure shall be adopted by the Management
Board, in agreement with the Commission.
This Title shall not otherwise affect the competences vested in
the European Food Safety Authority.
3. This Title shall not affect the competences vested in theEuropean Medicines Agency.

Participation of third countries
The Management Board may, in agreement with the relevantCommittee or the Forum, invite representatives of third countries to participate in the work of the Agency.
(1) OJ 17, 6.10.1958, p. 385/58. Regulation as last amended by Council
Regulation (EC) No 920/2005 (OJ L 156, 18.6.2005, p. 3).

4. The Executive Director, having consulted the Committee
on Risk Assessment, the Committee on Socio-economic
Analysis and the Advisory Committee on Safety, Hygiene and
Health Protection at Work, shall establish rules of procedure
concerning worker protection issues. These rules of procedure
shall be adopted by the Management Board, in agreement with
the Commission.

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This Title shall not affect the competences vested in the Advisory Committee on Safety, Hygiene and Health Protection at
Work and the European Agency for Health and Safety at Work.

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tion in order for it to be included in the inventory in accordancewith Article 114, unless submitted as part of the registration:(a) the identity(ies) of the manufacturer(s), producer(s) of articles or importer(s) responsible for placing the substance(s)on the market as specified in Section 1 of Annex VI;

Article 111
Formats and software for submission of information to the
AgencyThe Agency shall specify formats and make them available freeof charge, and software packages and make them available on
its website for any submissions to the Agency. Member States,
manufactures, importers, distributors or downstream users shalluse these formats and packages in their submissions to the
Agency pursuant to this Regulation. In particular, the Agency
shall make available software tools to facilitate the submissionof all information relating to substances registered in accordancewith Article 12(1).

(b) the identity of the substance(s) as specified in Sections 2.1
to 2.3.4 of Annex VI;(c) the hazard classification of the substance(s), resulting fromthe application of Articles 4 and 6 of Directive 67/548/EEC;(d) the hazard label for the substance(s), resulting from theapplication of Article 23(c) to (f), of Directive 67/548/EEC;(e) specific concentration limits, where applicable, resulting
from the application of Article 4(4) of Directive 67/548/
EEC and Articles 4 to 7 of Directive 1999/45/EC.

For the purposes of registration, the format of the technicaldossier referred to in Article 10(a) shall be IUCLID. The Agency
shall coordinate the further development of this format with theOrganisation for Economic Cooperation and Development toensure maximum harmonisation.

2. Where the obligation under paragraph 1 results indifferent entries on the inventory for the same substance, thenotifiers and registrants shall make every effort to come to anagreed entry to be included in the inventory.

TITLE XI

3. The information listed in paragraph 1 shall be updated by
the notifier(s) whenever:

CLASSIFICATION AND LABELLING INVENTORY

Article 112
Scope(a) any new scientific or technical information is generated
which results in a change to the classification and labellingof the substance;(b) notifiers and registrants of differing entries for a single
substance come to an agreed entry in accordance with paragraph 2.

This Title shall apply to:(a) substances subject to registration;(b) substances within the scope of Article 1 of Directive 67/
548/EEC, which meet the criteria for classification as
dangerous in accordance with that Directive, and which areplaced on the market either on their own, or in a preparation above the concentration limits specified in Directive 1999/45/EC, where relevant, which results in the classification of the preparation as dangerous.

Article 113
Obligation to notify the Agency
1.
Any manufacturer, producer of articles or importer, orgroup of manufacturers or producers of articles or importers,
who place on the market a substance within the scope of
Article 112, shall notify to the Agency the following informa-

Article 114

Classification and labelling inventory

1. A classification and labelling inventory, listing the information referred to in Article 113(1), both for information notified under Article 113(1) as well as for information submitted
as part of a registration, shall be established and maintained by
the Agency in the form of a database. The information in thisdatabase identified in Article 119(1) shall be publicly accessible.
The Agency shall grant access to the other data on each
substance in the inventory to the notifiers and registrants who
have submitted information on that substance in accordancewith Article 29(1).

The Agency shall update the inventory when it receives updated
information in accordance with Article 113(3).

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2.
In addition to the information referred to in paragraph 1,
the Agency shall record the following information, where appropriate, against each entry:

their respective territories, including sections on evaluation andenforcement as described in Article 127.

(a) whether, in respect of the entry, there is a harmonised classification and labelling at Community level by inclusion in
Annex I of Directive 67/548/EEC;

The first report shall be submitted by 1 June 2010.

(b) whether, in respect of the entry, it is a joint entry between
registrants of the same substance as per Article 11(1);(c) if the entry differs from another entry on the inventory forthe same substance;(d) the relevant registration number(s), if available.

Article 115
Harmonisation of classification and labelling1.
Harmonised classification and labelling at Community
level shall, from 1 June 2007, normally be added to Annex I of
Directive 67/548/EEC for classification of a substance as carcinogenic, mutagenic or toxic for reproduction category 1, 2 or
3, or as a respiratory sensitiser. Harmonised classification andlabelling for other effects may also be added to Annex I of
Directive 67/548/EEC on a case-by-case basis if justification isprovided demonstrating the need for action at Community level.
To this end, Member State competent authorities may submit
proposals to the Agency for harmonised classification and labelling in accordance with Annex XV.
2.
The Committee for Risk Assessment shall adopt an
opinion on the proposal, giving parties concerned the opportunity to comment. The Agency shall forward this opinion andany comments to the Commission, which shall take a decisionin accordance with Article 4(3) of Directive 67/548/EEC.

2. Every five years, the Agency shall submit to the Commission a report on the operation of this Regulation. The Agency
shall include in its report information on the joint submissionof information in accordance with Article 11 and an overview
of the explanations given for submitting information separately.
The first report shall be submitted by 1 June 2011.
3. Every three years the Agency, in accordance with theobjective of promoting non-animal testing methods, shallsubmit to the Commission a report on the status of implementation and use of non-animal test methods and testing strategies
used to generate information on intrinsic properties and for risk
assessment to meet the requirements of this Regulation.
The first report shall be submitted by 1 June 2011.
4. Every five years, the Commission shall publish a generalreport on:(a) the experience acquired with the operation of this Regulation, including the information referred to in paragraphs 1,
2 and 3 and;(b) the amount and distribution of funding made available by
the Commission for the development and evaluation ofalternative test methods.
The first report shall be published by 1 June 2012.

Article 116

Article 118

Transitional arrangements

Access to information

The obligations set out in Article 113 shall apply from
1 December 2010.

1. Regulation (EC) No 1049/2001 shall apply to documents
held by the Agency.

TITLE XII

2. Disclosure of the following information shall normally bedeemed to undermine the protection of the commercial interestsof the concerned person:

INFORMATION(a) details of the full composition of a preparation;
Article 117
Reporting(b) without prejudice to Article 7(6) and Article 64(2), theprecise use, function or application of a substance orpreparation, including information about its precise use as
an intermediate;1.
Every five years, Member States shall submit to theCommission a report on the operation of this Regulation in(c) the precise tonnage of the substance or preparation manufactured or placed on the market;

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Where urgent action is essential to protect human health, safetyor the environment, such as emergency situations, the Agency
may disclose the information referred to in this paragraph.
3.
The Management Board shall adopt the practical arrangements for implementing Regulation (EC) No 1049/2001,
including appeals or remedies necessary for reviewing a partial
or full rejection of a confidentiality request, by 1 June 2008.
4.
Decisions taken by the Agency pursuant to Article 8 ofRegulation (EC) No 1049/2001 may form the subject of acomplaint to the Ombudsman or of an action before the Courtof Justice, under the conditions laid down in Articles 195 and230 of the Treaty respectively.

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submits a justification in accordance with Article 10(a)(xi),
accepted as valid by the Agency, as to why such publication ispotentially harmful for the commercial interests of the registrant
or any other party concerned:(a) if essential to classification and labelling, the degree ofpurity of the substance and the identity of impurities and/or
additives which are known to be dangerous;(b) the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100
tonnes, 100 to 1 000 tonnes or over 1 000 tonnes) within
which a particular substance has been registered;(c) the study summaries or robust study summaries of theinformation referred to in paragraph 1(d) and (e);(d) information, other than that listed in paragraph 1, containedin the safety data sheet;(e) the trade name(s) of the substance;

Article 119(f) the name in the IUPAC Nomenclature for non-phase-in
substances which are dangerous within the meaning of
Directive 67/548/EEC for a period of six years;

Electronic public access
1.
The following information held by the Agency on
substances whether on their own, in preparations or in articles,
shall be made publicly available, free of charge, over the Internet
in accordance with Article 77(2)(e):(a) the name in the IUPAC Nomenclature, for dangerous
substances within the meaning of Directive 67/548/EEC,
without prejudice to paragraph 2(f) and (g);(g) the name in the IUPAC Nomenclature for dangerous
substances within the meaning of Directive 67/548/EEC thatare only used as one or more of the following:(i) as an intermediate;(ii) in scientific research and development;(iii) in product and process orientated research and development.

(b) if applicable, the name of the substance as given in EINECS;(c) the classification and labelling of the substance;(d) physicochemical data concerning the substance and on
pathways and environmental fate;(e) the result of each toxicological and ecotoxicological study;(f) any derived no-effect level (DNEL) or predicted no-effectconcentration (PNEC) established in accordance with
Annex I;(g) the guidance on safe use provided in accordance with
Sections 4 and 5 of Annex VI;(h) analytical methods if requested in accordance with
Annexes IX or X which make it possible to detect a
dangerous substance when discharged into the environment
as well as to determine the direct exposure of humans.
2.
The following information on substances whether on theirown, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with
Article 77(2)(e) except where a party submitting the information

Article 120

Cooperation with third countries and international organisations

Notwithstanding Articles 118 and 119, information received by
the Agency under this Regulation may be disclosed to any
government or national authority of a third country or an international organisation in accordance with an agreement
concluded between the Community and the third party
concerned under 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 (1) or under
Article 181a(3) of the Treaty, provided that both the following
conditions are met:(a) the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation;(1) OJ L 63, 6.3.2003, p. 1. Regulation as last amended by Commission
Regulation (EC) No 777/2006 (OJ L 136, 24.5.2006, p. 9).

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mutually agreed.
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29.5.2007

other interested parties on their respective responsibilities andobligations under this Regulation, in particular in relation to theregistration of substances in accordance with Article 12(1), in
addition to the operational guidance documents provided by the
Agency under Article 77(2)(g).

COMPETENT AUTHORITIESTITLE XIV

Article 121

ENFORCEMENT

Appointment
Article 125
Member States shall appoint the competent authority or competent authorities responsible for performing the tasks allotted tocompetent authorities under this Regulation and for cooperatingwith the Commission and the Agency in the implementation ofthis Regulation. Member States shall place adequate resources atthe disposal of the competent authorities to enable them, in
conjunction with any other available resources, to fulfil theirtasks under this Regulation in a timely and effective manner.

Tasks of the Member States
Member States shall maintain a system of official controls andother activities as appropriate to the circumstances.

Article 126
Article 122
Cooperation between competent authorities
The competent authorities shall cooperate with each other inthe performance of their tasks under this Regulation and shallgive the competent authorities of other Member States all thenecessary and useful support to this end.

Penalties for non-compliance
Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation andshall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those
provisions to the Commission no later than 1 December 2008
and shall notify it without delay of any subsequent amendment
affecting them.

Article 123
Communication to the public of information on risks ofsubstances

Article 127
Report

The competent authorities of the Member States shall informthe general public about the risks arising from substances where
this is considered necessary for the protection of human healthor the environment. The Agency, in consultation with competent authorities and stakeholders and drawing as appropriate on
relevant best practice, shall provide guidance for the communication of information on the risks and safe use of chemical
substances, on their own, in preparations or in articles, with aview to coordinating Member States in these activities.

The report referred to in Article 117(1) shall, in relation to
enforcement, include the results of the official inspections, themonitoring carried out, the penalties provided for and the othermeasures taken pursuant to Articles 125 and 126 during theprevious reporting period. The common issues to be covered in
the reports shall be agreed by the Forum. The Commission shallmake these reports available to the Agency and the Forum.
TITLE XV

Article 124

TRANSITIONAL AND FINAL PROVISIONSOther responsibilities
Competent authorities shall submit electronically to the Agency
any available information that they hold on substances registered in accordance with Article 12(1) whose dossiers do notcontain the full information referred to in Annex VII, in particular whether enforcement or monitoring activities have identified
suspicions of risk. The competent authority shall update thisinformation as appropriate.
Member States shall establish national helpdesks to provide
advice to manufacturers, importers, downstream users and any

Article 128
Free movement
1. Subject to paragraph 2, Member States shall not prohibit,
restrict or impede the manufacturing, import, placing on themarket or use of a substance, on its own, in a preparation or in
an article, falling within the scope of this Regulation, which
complies with this Regulation and, where appropriate, with
Community acts adopted in implementation of this Regulation.

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2.
Nothing in this Regulation shall prevent Member Statesfrom maintaining or laying down national rules to protect
workers, human health and the environment applying in cases
where this Regulation does not harmonise the requirements on
manufacture, placing on the market or use.

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Article 132
Implementing legislation

The measures necessary to put the provisions of this Regulation
efficiently into effect shall be adopted in accordance with theprocedure referred to in Article 133(3).

Article 129
Article 133

Safeguard clause
1.
Where a Member State has justifiable grounds forbelieving that urgent action is essential to protect human healthor the environment in respect of a substance, on its own, in a
preparation or in an article, even if satisfying the requirementsof this Regulation, it may take appropriate provisional measures.
The Member State shall immediately inform the Commission,
the Agency and the other Member States thereof, giving reasonsfor its decision and submitting the scientific or technical information on which the provisional measure is based.
2.
The Commission shall take a decision in accordance withthe procedure referred to in Article 133(3) within 60 days ofreceipt of the information from the Member State. This decision
shall either:(a) authorise the provisional measure for a time period definedin the decision; or(b) require the Member State to revoke the provisional measure.

Committee procedure
1.

The Commission shall be assisted by a Committee.

2. Where reference is made to this paragraph, Articles 3 and
7 of Decision 1999/468/EC shall apply, having regard to theprovisions of Article 8 thereof.
3. Where reference is made to this paragraph, Articles 5 and
7 of Decision 1999/468/EC shall apply, having regard to theprovisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.
4. Where reference is made to this paragraph, Article 5a(1)to (4), and Article 7 of Decision 1999/468/EC shall apply,
having regard to the provisions of Article 8 thereof.

3.
If, in the case of a decision as referred to in paragraph 2(a), the provisional measure taken by the Member State consists
in a restriction on the placing on the market or use of a
substance, the Member State concerned shall initiate a Community restrictions procedure by submitting to the Agency adossier, in accordance with Annex XV, within three months ofthe date of the Commission decision.

5.

4.
In the case of a decision as referred to in paragraph 2(a),the Commission shall consider whether this Regulation needs tobe adapted.

1. The Commission shall afford the necessary support
towards the establishment of the Agency.

Article 130
Statement of reasons for decisions
The competent authorities, the Agency and the Commission
shall state the reasons for all decisions they take under thisRegulation.

The Committee shall adopt its Rules of Procedure.

Article 134
Preparation of establishment of the Agency

2. For that purpose, until such time as the Executive Director
takes up his duties following his appointment by the Management Board of the Agency in accordance with Article 84, theCommission, on behalf of the Agency, and using the budget
provided for the latter, may:(a) appoint personnel, including a person who shall fulfil theadministrative functions of the Executive Director on aninterim basis; and(b) conclude other contracts.

Article 135
Article 131
Amendments to the Annexes
The Annexes may be amended in accordance with the procedure referred to in Article 133(4).

Transitional measures regarding notified substances
1. The requests to notifiers to provide further information to
the competent authority in accordance with Article 16(2) ofDirective 67/548/EEC, shall be considered as decisions adopted
in accordance with Article 51 of this Regulation.

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2.
The requests to a notifier to provide further information
for a substance in accordance with Article 16(1) of Directive
67/548/EEC, shall be considered as decisions adopted in accordance with Article 52 of this Regulation.

29.5.2007
Article 137

Transitional measures regarding restrictions

Such substance shall be regarded as being included in the Community rolling action plan in accordance with Article 44(2) ofthis Regulation and shall be regarded as being chosen in accordance with Article 45(2) of this Regulation by the Member State
whose competent authority has requested further information inaccordance with Article 7(2) and Article 16(1) of Directive 67/
548/EEC.

1. By 1 June 2010, the Commission shall, if necessary,
prepare a draft amendment to Annex XVII in accordance witheither of the following:

Article 136(b) any proposal, which has been submitted to the relevant
institutions but has not yet been adopted, concerning the
introduction or the amendment of restrictions under Directive 76/769/EEC.

Transitional measures regarding existing substances1.
The requests to manufacturers and importers to submit
information to the Commission made by a Commission Regulation in application of Article 10(2) of Regulation (EEC)
No 793/93, shall be considered as decisions adopted in accordance with Article 52 of this Regulation.

The competent authority for the substance shall be the competent authority from the Member State identified as rapporteur inaccordance with Article 10(1) of Regulation (EEC) No 793/93
and shall carry out the tasks of Article 46(3) and Article 48 of
this Regulation.

2.
The requests to manufacturers and importers to submit
information to the Commission made by a Commission Regulation in application of Article 12(2) of Regulation (EEC)
No 793/93, shall be considered as decisions adopted in accordance with Article 52 of this Regulation. The Agency shall identify the competent authority for the substance to carry out thetasks of Article 46(3) and Article 48 of this Regulation.

3.
A Member State whose rapporteur has not forwarded by
1 June 2008 the risk evaluation and, where appropriate, thestrategy for limiting the risks, in accordance with Article 10(3)of Regulation (EEC) No 793/93, shall:(a) document information on hazard and risk in accordancewith Annex XV, Part B of this Regulation;(b) apply Article 69(4) of this Regulation on the basis of theinformation referred to in point (a); and(c) prepare a documentation of how it considers that any otherrisks identified would need to be addressed by action otherthan an amendment of Annex XVII of this Regulation.
The information referred to above shall be submitted to the
Agency by 1 December 2008.

(a) any risk evaluation and recommended strategy for limiting
risks that has been adopted at Community level in accordance with Article 11 of Regulation (EEC) No 793/93 as far
as it includes proposals for restrictions in accordance withTitle VIII of this Regulation but for which a decision underDirective 76/769/EEC has not yet been taken;

2. Until 1 June 2010, any dossier referred to in Article 129(3) shall be submitted to the Commission. The Commission
shall, if necessary, prepare a draft amendment to Annex XVII.

3. Any amendment to the restrictions adopted under Directive 76/769/EEC from 1 June 2007 shall be incorporated in
Annex XVII with effect from 1 June 2009.

Article 138

Review

1. By 1 June 2019, the Commission shall carry out a review
to assess whether or not to extend the application of the obligation to perform a chemical safety assessment and to document
it in a chemical safety report to substances not covered by thisobligation because they are not subject to registration or subject
to registration but manufactured or imported in quantities ofless than 10 tonnes per year. However, for substances meetingthe criteria for classification as carcinogenic, mutagenic or toxic
for reproduction, category 1 or 2, in accordance with Directive 67/548/EEC, the review shall be carried out by 1 June
2014. When carrying out the review the Commission shall take
into account all relevant factors, including:(a) the costs for manufacturers and importers of drawing up
the chemical safety reports;(b) the distribution of costs between actors in the supply chain
and the downstream user;(c) the benefits for human health and the environment.
On the basis of these reviews, the Commission may, if appropriate, present legislative proposals to extend this obligation.

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2.
The Commission may present legislative proposals as soon
as a practicable and cost-efficient way of selecting polymers forregistration on the basis of sound technical and valid scientificcriteria can be established, and after publishing a report on thefollowing:

8. By 1 June 2019, the Commission shall carry out a review
to assess whether or not to extend the scope of Article 33 tocover other dangerous substances, taking into account the practical experience in implementing that Article. On the basis ofthat review, the Commission may, if appropriate, present legislative proposals to extend that obligation.

(a) the risks posed by polymers in comparison with othersubstances;

9. In accordance with the objective of promoting non-animal
testing and the replacement, reduction or refinement of animal
testing required under this Regulation, the Commission shallreview the testing requirements of Section 8.7 of Annex VIII by
1 June 2019. On the basis of this review, while ensuring a highlevel of protection of health and the environment, the Commission may propose an amendment in accordance with the procedure referred to in Article 133(4).

(b) the need, if any, to register certain types of polymer, taking
account of competitiveness and innovation on the one hand
and the protection of human health and the environmenton the other.

3.
The report, referred to in Article 117(4), on the experienceacquired with the operation of this Regulation shall include a
review of the requirements relating to registration of substances
manufactured or imported only in quantities starting at one
tonne but less than 10 tonnes per year per manufacturer orimporter. On the basis of that review, the Commission may
present legislative proposals to modify the information requirements for substances manufactured or imported in quantities of
one tonne or more up to 10 tonnes per year per manufacturer
or importer, taking into account the latest developments, forexample in relation to alternative testing and (quantitative) structure-activity relationships ((Q)SARs).

Article 139
Repeals
Directive 91/155/EEC shall be repealed.
Directives 93/105/EC and 2000/21/EC and Regulations (EEC)
No 793/93 and (EC) No 1488/94 shall be repealed with effectfrom 1 June 2008.
Directive 93/67/EEC shall be repealed with effect from 1 August
2008.

4.
The Commission shall carry out a review of Annexes I, IV
and V by 1 June 2008, with a view to proposing amendments,
if appropriate, to them in accordance with the procedurereferred to in Article 131.

5.
The Commission shall carry out a review of Annex XIII by
1 December 2008, to assess the adequacy of the criteria for
identifying substances which are persistent, bioaccumulative andtoxic or very persistent and very bioaccumulative, with a viewto proposing an amendment to it, if appropriate, in accordancewith the procedure referred to in Article 133(4).

Directive 76/769/EEC shall be repealed with effect from 1 June2009.
References to the repealed acts shall be construed as references
to this Regulation.

Article 140
Amendment of Directive 1999/45/EC
Article 14 of Directive 1999/45/EC shall be deleted.

Article 141

6.
By 1 June 2012 the Commission shall carry out a review
to assess whether or not to amend the scope of this Regulation
to avoid overlaps with other relevant Community provisions.
On the basis of that review, the Commission may, if appropriate,
present a legislative proposal.

Entry into force and application1.

7.
By 1 June 2013 the Commission shall carry out a review
to assess whether or not, taking into account latest developments in scientific knowledge, to extend the scope of Article 60(3) to substances identified under Article 57(f) as having endocrine disrupting properties. On the basis of that review theCommission may, if appropriate, present legislative proposals.

This Regulation shall enter into force on 1 June 2007.

2. Titles II, III, V, VI, VII, XI and XII as well as Articles 128
and 136 shall apply from 1 June 2008.
3.

Article 135 shall apply from 1 August 2008.

4.

Title VIII and Annex XVII shall apply from 1 June 2009.

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This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 December 2006.

For the European Parliament

For the Council

The President

The President

J. BORRELL FONTELLES

M. VANHANEN