02006R1907 — EN — 10.10.2017 — 035.001

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B ▼C1 REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance) ▼B (OJ L 396 30.12.2006, p. 1)

Amended by:





Corrected by:









▼B

▼C1

REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 18 December 2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC

(Text with EEA relevance)







TABLE OF CONTENTS TITLE I GENERAL ISSUES Chapter 1 Aim, scope and application Chapter 2 Definitions and general provision TITLE II REGISTRATION OF SUBSTANCES Chapter 1 General obligation to register and information requirements Chapter 2 Substances regarded as being registered Chapter 3 Obligation to register and information requirements for certain types of isolated intermediates Chapter 4 Common provisions for all registrations Chapter 5 Transitional provisions applicable to phase-in substances and notified substances TITLE III DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING Chapter 1 Objectives and general rules Chapter 2 Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered Chapter 3 Rules for phase-in-substances TITLE IV INFORMATION IN THE SUPPLY CHAIN TITLE V DOWNSTREAM USERS TITLE VI EVALUATION Chapter 1 Dossier evaluation Chapter 2 Substance evaluation Chapter 3 Evaluation of intermediates Chapter 4 Common provisions TITLE VII AUTHORISATION Chapter 1 Authorisation requirement Chapter 2 Granting of authorisations Chapter 3 Authorisations in the supply chain TITLE VIII RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES AND ►M3 MIXTURES ◄ Chapter 1 General issues Chapter 2 Restrictions process TITLE IX FEES AND CHARGES TITLE X AGENCY TITLE XII INFORMATION TITLE XIII COMPETENT AUTHORITIES TITLE XIV ENFORCEMENT TITLE XV TRANSITIONAL AND FINAL PROVISIONS ANNEX I GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS ANNEX II REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS ANNEX III CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES ANNEX IV EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a) ANNEX V EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b) ANNEX VI INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE ANNEX VIII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE ANNEX IX STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE ANNEX X STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE ANNEX XI GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X ANNEX XII GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS ANNEX XIII CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION ANNEX XV DOSSIERS ANNEX XVI SOCIO-ECONOMIC ANALYSIS ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, MIXTURES AND ARTICLES







TITLE I

GENERAL ISSUES







CHAPTER 1

Aim, scope and application

Article 1

Aim and scope

1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.

2. This Regulation lays down provisions on substances and ►M3 mixtures ◄ within the meaning of Article 3. These provisions shall apply to the manufacture, placing on the market or use of such substances on their own, in ►M3 mixtures ◄ or in articles and to the placing on the market of ►M3 mixtures ◄ .

3. This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that 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 from ionising radiation ( 1 );

(b) substances, on their own, in a ►M3 mixture ◄ 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 warehouse with a view to re-exportation, or in transit;

(c) non-isolated intermediates;

(d) the carriage of dangerous substances and dangerous substances in dangerous ►M3 mixtures ◄ 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, ►M3 mixture ◄ or article within the meaning of Article 3 of this Regulation.

3. Member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a ►M3 mixture ◄ or in an article, where necessary in the interests of defence.

4. This Regulation shall apply without prejudice to:

(a) Community workplace and environmental legislation, including Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in 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 and of 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 to the 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 to veterinary medicinal products ( 6 ) and Directive 2001/83/EC of 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 of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption ( 8 );

(ii) as a flavouring in foodstuffs within the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production ( 9 ) 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 ( 10 );

(iii) as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition ( 11 );

(iv) in animal nutrition within the scope of Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition ( 12 ).

6. The provisions of Title IV shall not apply to the following ►M3 mixtures ◄ in the finished state, intended for the final user:

(a) medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC;

(b) cosmetic products as defined in Directive 76/768/EEC;

(c) medical devices which are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and ►M3 mixtures ◄ 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:

(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;

(iii) as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003;

(iv) in animal nutrition within the scope of Directive 82/471/EEC.

7. The following shall be exempted from Titles II, V and VI:

(a) substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause 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 exemption from these Titles does not prejudice the objectives of this Regulation;

(c) substances on their own or in ►M3 mixtures ◄ , registered in accordance with Title II, exported from the Community by an 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 the exported substance;

(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 ►M3 mixtures ◄ or in articles, which have been registered in accordance with Title II and which are recovered in the Community if:

(i) the substance that results from the recovery process is the same as the substance that has been registered in accordance with Title II; and

(ii) the information required by Articles 31 or 32 relating to the substance that has been registered in accordance with Title II is available to the establishment undertaking the recovery.

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.

9. The provisions of Titles II and VI shall not apply to polymers.







CHAPTER 2

Definitions and general provision

Article 3

Definitions

For the purposes of this Regulation:

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

2. ►M3 mixture ◄ : 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 of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:

(a) a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;

(b) less than a simple weight majority of molecules of the same 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 polymer-forming 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 or extraction of substances in the natural state;

9. manufacturer: means any natural or legal person established within the Community who manufactures a substance within the Community;

10. import: means the physical introduction into the customs territory of the Community;

11. importer: means any natural or legal person established within 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 a third party. Import shall be deemed to be placing on the market;

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 or in a ►M3 mixture ◄ , 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;

14. distributor: means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a ►M3 mixture ◄ , for third parties;

15. intermediate: means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis):

(a) non-isolated intermediate: means an intermediate that during 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 for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;

(b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities;

(c) transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites;

16. site: means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared;

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 or bodies 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);

▼M23

(b) it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004, on 1 January 2007 or on 1 July 2013, 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, provided the manufacturer or importer has documentary evidence of this;

(c) it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004, on 1 January 2007 or on 1 July 2013, by the manufacturer or importer before the entry into force of this Regulation and it was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC in the version of Article 8(1) resulting from the amendment effected by Directive 79/831/EEC, but it does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this, including proof that the substance was placed on the market by any manufacturer or importer between 18 September 1981 and 31 October 1993 inclusive;

▼C1

21. notified substance: means a substance for which a notification has been submitted and which could be placed on the market 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 ►M3 mixtures ◄ or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance;

23. scientific research and development: means any scientific experimentation, 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, transfer from one container to another, mixing, production of an article or any other utilisation;

25. registrant's own use: means an industrial or professional use by the registrant;

26. identified use: means a use of a substance on its own or in a ►M3 mixture ◄ , or a use of a ►M3 mixture ◄ , that is intended by an actor in the supply chain, including his own use, or that is 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 the study performed;

28. robust study summary: means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report;

29. study summary: means a summary of the objectives, methods, results and conclusions of a full study report providing 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 manufactured 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 ►M3 mixture ◄ : means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a ►M3 mixture ◄ , or a ►M3 mixture ◄ ;

33. supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market;

34. recipient of a substance or a ►M3 mixture ◄ : means a downstream user or a distributor being supplied with a substance or a ►M3 mixture ◄ ;

35. recipient of an article: means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers;

36. SME: means small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises ( 13 );

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 the processes 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 by manual, 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 which is 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 physical mineralogical 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.

Article 4

General provision

Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his 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 not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users.







TITLE II

REGISTRATION OF SUBSTANCES







CHAPTER 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 ►M3 mixtures ◄ or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required.

Article 6

General obligation to register substances on their own or in ►M3 mixtures ◄

1. Save where this Regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in one or more ►M3 mixture ◄ (s), in quantities of one tonne or more per year shall submit a registration to the Agency.

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

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

(a) the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s);

(b) the total quantity of such monomer substance(s) or other substance(s) makes up one tonne or more per year.

4. A submission for registration shall be accompanied by the fee required in accordance with Title IX.

Article 7

Registration and notification of substances in articles

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 or reasonably 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 a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), 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 present in those articles above a concentration of 0,1 % weight by weight (w/w).

3. Paragraph 2 shall not apply where the producer or importer 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.

4. The information to be notified shall include the following:

(a) the identity and contact details of the producer or importer as 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;

(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 the article as specified in section 3.5 of Annex VI and of the uses of the article(s);

(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 or importers of articles to submit a registration, in accordance with this 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 a risk 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 have already 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 to in Article 133(3).

Article 8

Only representative of a non-Community manufacturer

1. A natural or legal person established outside the Community who manufactures a substance on its own, in ►M3 mixtures ◄ or in articles, formulates a ►M3 mixture ◄ or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community 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 shall have 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 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 inform the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation.

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 a period 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 or importer 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 or importer or producer of articles shall notify the Agency of the following information:

(a) the identity of the manufacturer or importer or producer of articles as specified in section 1 of Annex VI;

(b) the identity of the substance, as specified in section 2 of Annex VI;

(c) the classification of the substance as specified in section 4 of Annex VI, if any;

(d) the estimated quantity as specified in section 3.1 of Annex VI;

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

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

The period set out in paragraph 1 shall begin at receipt of the notification 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 the notification and a notification date, which shall be the date of receipt 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 shall also communicate this information to the competent authority of the Member State(s) concerned.

4. The Agency may decide to impose conditions with the aim of ensuring that the substance or the ►M3 mixture ◄ or article in which the substance is incorporated will be handled only by staff of listed customers as referred to in paragraph 2(e) in reasonably controlled conditions, in accordance with the requirements of legislation for the protection of workers and the environment, and will not be made available to the general public at any time either on its own or in a ►M3 mixture ◄ or article and that remaining quantities will be re-collected for disposal after the exemption period.

In such cases, the Agency may ask the notifier to provide additional necessary information.

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

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

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 substances that are not placed on the market, for a further maximum of ten years, upon request if the manufacturer or importer or producer of articles can demonstrate that such an extension is justified by the research and development programme.

8. The Agency shall forthwith communicate any draft decisions to the competent authorities of each Member State in which the manufacture, import, production or product and process 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 such competent authorities.

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.

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.

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:

(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 2 of Annex VI;

(iii) information on the manufacture and use(s) of the substance as specified in section 3 of Annex VI; this information 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;

(vi) study summaries of the information derived from the application 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 been reviewed by an assessor chosen by the manufacturer or importer and having appropriate experience;

(ix) proposals for testing where listed in Annexes IX and X;

(x) for substances in quantities of 1 to 10 tonnes, exposure information as specified in section 6 of Annex VI;

(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 other concerned party's commercial interests.

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

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

Article 11

Joint submission of data by multiple registrants

1. When a substance is intended to be manufactured in the Community 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.

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).

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).

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 for items 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 this information jointly; or

(b) submitting the information jointly would lead to disclosure of 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 this information.

If points (a), (b) or (c) apply, the registrant shall submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment or the nature of the disagreement, as the case may be.

4. A submission for registration shall be accompanied by the fee required in accordance with Title IX.

Article 12

Information to be submitted depending on tonnage

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 is relevant and available to the registrant and as a minimum the following:

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

(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 the criteria 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 and testing 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 and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported 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 inform the Agency immediately of the additional information he would require under paragraph 1. Article 26(3) and (4) shall apply adapted as necessary.

3. This Article shall apply to producers of articles adapted as necessary.

Article 13

General requirements for generation of information on intrinsic properties of substances

1. Information on intrinsic properties of substances may be generated 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 means other 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 information from 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 the number of animals involved. The Commission, following consultation with relevant stakeholders, shall, as soon as possible, make a proposal, if appropriate, to amend the Commission Regulation on test methods adopted in accordance with the procedure referred to in Article 133(4), and the Annexes of this Regulation, if relevant, so as to replace, reduce or 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 of this 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 of this Regulation by supplementing it, in accordance with the procedure referred to in Article 133(4).

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

4. Ecotoxicological and toxicological tests and analyses shall be carried out in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC or other international standards recognised as being equivalent by the Commission 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 degree of 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 to provide 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, a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter in quantities of 10 tonnes or more per year per registrant.

The chemical safety report shall document the chemical safety assessment 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 ►M3 mixture ◄ or in an article or a group of substances.

▼M3

2. A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a mixture if the concentration of the substance in the mixture is less than:

(a) the cut-off value referred to in Article 11, paragraph 3 of Regulation (EC) No 1272/2008;

(b) 0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII to this Regulation.

▼C1

3. A chemical safety assessment of a substance shall include the following steps:

(a) human health hazard assessment;

(b) physicochemical hazard assessment;

(c) environmental hazard assessment;

(d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.

▼M3

4. If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(c) hazard class 4.1;

(d) hazard class 5.1,

or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:

▼C1

(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 shall address all identified uses of the registrant.

5. The chemical safety report need not include consideration of 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 the Council of 27 October 2004 on materials and articles intended to come into contact with food ( 14 );

(b) in cosmetic products within the scope of Directive 76/768/EEC.

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

7. Any registrant required to conduct a chemical safety assessment shall keep his chemical safety report available and up to date.







CHAPTER 2

Substances regarded as being registered

Article 15

Substances in plant protection and biocidal products

1. Active substances and co-formulants manufactured or imported for use in plant protection products only and included either in Annex I to Council Directive 91/414/EEC ( 15 ) or in Commission Regulation (EEC) No 3600/92 ( 16 ), Commission Regulation (EC) No 703/2001 ( 17 ), Commission Regulation (EC) No 1490/2002 ( 18 ), or Commission Decision 2003/565/EC ( 19 ) and for any substance for which a Commission Decision on the completeness of the dossier has been taken pursuant to Article 6 of Directive 91/414/EEC shall be regarded as being registered and 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. Active substances manufactured or imported for use in biocidal products only and included either in Annexes I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market ( 20 ) or in Commission Regulation (EC) No 2032/2003 ( 21 ) 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 and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title.

Article 16

Duties of the Commission, the Agency and registrants of substances regarded as being registered

1. The Commission or the relevant Community body shall make information equivalent to that required by Article 10 available to the Agency for substances regarded as registered according to Article 15. The Agency shall include this information or a reference thereto in its databases and notify the competent authorities thereof by 1 December 2008.

2. Articles 21, 22 and 25 to 28 shall not apply to uses of substances regarded as registered according to Article 15.







CHAPTER 3

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

Article 17

Registration of on-site isolated intermediates

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

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 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 4 of 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;

(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 of or 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 in accordance 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 in that 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.

Article 18

Registration of transported isolated intermediates

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

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

(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 4 of 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;

(f) information on risk management measures applied and recommended 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 of or 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 in accordance with Title IX.

3. A registration for a transported isolated intermediate in quantities 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.

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 the user 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;

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

(c) only properly trained and authorised personnel handle the substance;

(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;

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

(f) substance-handling procedures are well documented and strictly 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.

Article 19

Joint submission of data on isolated intermediates by multiple registrants

1. When an on-site isolated intermediate or transported isolated intermediate is intended to be manufactured in the 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 first be submitted by one manufacturer or importer acting with the agreement 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 information referred to in Article 17(2)(c) or (d) and Article 18(2)(c) or (d) separately if:

(a) it would be disproportionately costly for him to submit this jointly; or

(b) submitting the information jointly would lead to disclosure of 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 this information.

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

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







CHAPTER 4

Common provisions for all registrations

Article 20

Duties of the Agency

1. The Agency shall assign a submission number to each registration, which is to be used for all correspondence regarding the registration until the registration is deemed to be complete, and a submission date, which shall be the date of receipt of the registration at the Agency.

2. The Agency shall undertake a completeness check of each registration 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 the quality or the adequacy of any data or justifications submitted.

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 of phase-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 shall complete his registration and submit it to the Agency within the deadline set. The Agency shall confirm the submission date of the further information to the registrant. The Agency shall perform a further completeness check, considering the further information submitted.

The Agency shall reject the registration if the registrant fails to complete 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 the relevant 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 or registration number;

(b) the submission or registration date;

(c) the result of the completeness check; and

(d) any request for further information and deadline set in accordance 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 in which the head office of the manufacturer is established. The other Member States where the production sites are established shall 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.

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 is submitted to the Agency by a new registrant, the Agency shall notify the existing registrants that this information is available on the database for the purposes of Article 22.

Article 21

Manufacturing and import of substances

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 in accordance with Article 20(2) within the three weeks after the submission 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 substance or 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 contrary from the Agency in accordance with Article 20(2) within the three months from that deadline, without prejudice to Article 27(8).

In the case of an update of a registration according to Article 22 a registrant may continue the manufacture or import of the substance, or the production or import of the article, if there is no indication to the contrary from the Agency in accordance with 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 to submit 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 an article if there is no indication to the contrary from the Agency within the three weeks after receipt by the Agency of the further 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 2 of this Article and provided that there is no indication to the contrary from the Agency in respect of the registration of the lead registrant acting on behalf of the others and his own registration.

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;

(b) any change in the composition of the substance as given in Section 2 of Annex VI;

(c) changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change 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 human health 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 the substance;

(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 the registration 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 shall notify the competent authority of the relevant Member State that the information is available on its database.

3. The Agency shall undertake a completeness check according to Article 20(2) first and second subparagraphs of each updated registration. In cases where the update is in accordance with Article 12(2) and with paragraph 1(c) of this Article then the Agency shall check the completeness of the information supplied by the registrant and Article 20(2) shall apply adapted as necessary.

4. In cases covered by Articles 11 or 19, each registrant shall submit 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 and notified substances

Article 23

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 the following 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 the aquatic environment (R50/53) in accordance with Directive 67/548/EEC, and manufactured in the Community or imported 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 or imported, 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, in quantities 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, in quantities 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 can be submitted at any time before the relevant deadline.

5. This Article shall also apply to substances registered under Article 7 adapted as necessary.

Article 24

Notified substances

1. 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 or imported 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 in accordance with Articles 10 and 12, unless it has already been submitted in accordance with those Articles.







TITLE III

DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING







CHAPTER 1

Objectives and general rules

Article 25

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 in accordance with this Regulation shall concern technical data and 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 of studies submitted in the framework of a registration under this Regulation 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

Article 26

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

(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 of Annex 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.

3. If the same substance has previously been registered less than 12 years earlier, the Agency shall inform the potential registrant without delay of the names and addresses of the previous registrant(s) and of the relevant summaries or robust study summaries, as the case may be, already submitted by them.

Studies involving vertebrate animals shall not be repeated.

The Agency shall simultaneously inform the previous registrants of the name and address of the potential registrant. The available studies shall be shared with the potential registrant in accordance with Article 27.

4. If several potential registrants have made an inquiry in respect of the same substance, the Agency shall inform all potential registrants without delay of the name and address of the 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; and

(b) may, in the case of information not involving tests on vertebrate animals,

request from the previous registrant(s) the information he requires with respect to Article 10(a)(vi) and (vii) in order to register.

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 the potential registrant(s) with respect to Article 10(a)(vi) and (vii). Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order.

3. The previous registrant and potential registrant(s) shall make 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, the previous registrant shall make available to the new registrant the agreed 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 information referred to in paragraph 5, the Agency shall give the potential registrant permission to refer to the information requested by him 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 the potential registrant for a proportionate share of the cost incurred by him. Calculation of the proportionate share may be facilitated by the guidance adopted by the Agency in accordance with Article 77(2)(g). Provided he makes the full study report available to the potential registrant, the previous registrant(s) shall have a claim on the potential registrant for an equal share of the cost incurred by him, which shall be enforceable in the national 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 a period of four months, if the previous registrant so requests.







CHAPTER 3

Rules for phase-in-substances

Article 28

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 of Annex VI, including its EINECS and CAS number or, if not available, 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 tonnage band;

(d) the name(s) of substance(s) as specified in Section 2 of Annex 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 of Sections 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 and ending 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 other identity 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 details of 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.

6. Potential registrants who manufacture or import for the first time a phase-in substance in quantities of one tonne or more per year or use for the first time a phase-in substance in the context of production of articles or import for the first time an article containing a phase-in substance that would require registration, after 1 December 2008, shall be entitled to rely on Article 23 provided that they submit the information referred to in paragraph 1 of this Article to the Agency within six months of first manufacturing, importing or using the substance in quantities 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 in quantities 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 and third 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 the substance information exchange forum as referred to in Article 29.

Article 29

Substance Information Exchange Forums

1. All potential registrants, downstream users and third parties who have submitted information to the Agency in accordance 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 for that 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 of the 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 difference in the classification and labelling of the substance between potential registrants.

3. SIEF participants shall provide other participants with existing 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 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 shall provide proof of its cost to the participant(s) requesting it. The participant(s) and the owner shall make 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 any cost sharing guidance which is based on those principles and is adopted by the Agency in accordance with 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.

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 to reach an agreement within a deadline set by the Agency as to who 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 date of registration of the other participant(s), the owner of this information 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 by another 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 the full study report available to the other participant(s), which shall be enforceable in the national courts.

4. If the owner of a study as referred to in paragraph 1 which does not involve testing on vertebrate animals refuses to provide either proof of the cost of that study or the study itself to (an)other participant(s), the other SIEF participants shall proceed 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 3 of 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 IV

INFORMATION IN THE SUPPLY CHAIN

Article 31

Requirements for safety data sheets

1. The supplier of a substance or a ►M3 mixture ◄ shall provide the recipient of the substance or ►M3 mixture ◄ with a safety data sheet compiled in accordance with Annex II:

▼M3

(a) where a substance or mixture meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008; or

▼C1

(b) where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII; or

(c) where a substance is included in the list established in accordance with Article 59(1) for reasons other than those referred 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 ►M3 mixture ◄ and the actor in the supply chain has prepared a chemical safety assessment for that ►M3 mixture ◄ , it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the ►M3 mixture ◄ instead of with the chemical safety report for each substance in the ►M3 mixture ◄ .

▼M3

3. The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains:

(a) in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures at least one substance posing human health or environmental hazards; or

(b) in an individual concentration of ≥ 0,1 % by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or

(c) a substance for which there are Community workplace exposure limits.

4. The safety data sheet need not be supplied where hazardous substances or mixtures offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor.

▼C1

5. The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or ►M3 mixture ◄ is placed on the market, unless the Member State(s) concerned provide otherwise.

6. The safety data sheet shall be dated and shall contain the following headings:

1. identification of the substance/ ►M3 mixture ◄ and of the company/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;

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 a chemical 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.

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

▼M3

8. A safety data sheet shall be provided free of charge on paper or electronically no later than the date on which the substance or mixture is first supplied.

▼C1

9. Suppliers shall update the safety data sheet without delay on the following occasions:

(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;

(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 the substance or ►M3 mixture ◄ within the preceding 12 months. Any updates following registration shall include the registration number.

▼M3

10. Where substances are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 December 2010, that classification may be added in the safety data sheet together with the classification in accordance with Directive 67/548/EEC.

From 1 December 2010 until 1 June 2015, the safety data sheets for substances shall contain the classification according to both Directive 67/548/EEC and Regulation (EC) No 1272/2008.

Where mixtures are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 June 2015, that classification may be added in the safety data sheet, together with the classification in accordance with Directive 1999/45/EC. However, until 1 June 2015, where substances or mixtures are both classified and labelled in accordance with Regulation (EC) No 1272/2008 that classification shall be provided in the safety data sheet, together with the classification in accordance with Directives 67/548/EEC and 1999/45/EC respectively, for the substance, the mixture and its constituents.

▼C1

Article 32

Duty to communicate information down the supply chain for substances on their own or in ►M3 mixtures ◄ for which a safety data sheet is not required

1. Any supplier of a substance on its own or in a ►M3 mixture ◄ who does not have to supply a safety data sheet in accordance with 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 is communicated 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;

(d) any other available and relevant information about the substance that is necessary to enable appropriate risk management measures to be identified and applied including specific conditions resulting from the application of Section 3 of Annex XI.

2. The information referred to in paragraph 1 shall be communicated free of charge on paper or electronically at the latest at the time of the first delivery of a substance on its own or in a ►M3 mixture ◄ after 1 June 2007.

3. Suppliers shall update this information without delay on the following occasions:

(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;

(c) once a restriction has been imposed.

In addition, the updated information shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or ►M3 mixture ◄ within the preceding 12 months. Any updates following registration shall include the registration number.

Article 33

Duty to communicate information on substances in articles

1. Any supplier of an article containing a substance meeting the 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 the article 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 and identified 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 of that 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 and ►M3 mixtures ◄ up the supply chain

Any actor in the supply chain of a substance or a ►M3 mixture ◄ shall communicate the following information to the next actor or distributor up the supply chain:

(a) new information on hazardous properties, regardless of the uses concerned;

(b) any other information that might call into question the appropriateness 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 ►M3 mixtures ◄ that they use or may be exposed to in the course of their work.

Article 36

Obligation to keep information

1. Each manufacturer, importer, downstream user and distributor shall assemble and keep available all the information he requires to carry out his duties under this Regulation for a period of at least 10 years after he last manufactured, imported, supplied or used the substance or ►M3 mixture ◄ . That manufacturer, importer, downstream user or distributor shall submit this information or make it available without delay upon request to any competent authority of the Member State in which he is established 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 a third 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 or ►M3 mixture ◄ concerned shall be bound by the obligation in paragraph 1 in place of the registrant, downstream user or distributor.







TITLE V

DOWNSTREAM USERS

Article 37

Downstream user chemical safety assessments and duty to identify, 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 with a substance on its own or in a ►M3 mixture ◄ with the aim of making this an identified use. In making a use known, he shall provide 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 and exposure category, for his use in the manufacturer, importer or downstream 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 of such information may prepare an exposure scenario for the identified use(s), or pass the information to the next actor up the supply chain.

3. For registered substances, the manufacturer, importer or downstream user shall comply with the obligations laid down in Article 14 either before he next supplies the substance on its own or in a ►M3 mixture ◄ to the downstream user making the request referred to in paragraph 2 of this Article, provided that the request was made at least one month before the supply, or within one month after the request, whichever is the later.

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 in question.

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

4. A downstream user of a substance on its own or in a ►M3 mixture ◄ shall prepare a chemical safety report in accordance with 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 with the substance or ►M3 mixture ◄ in accordance with Article 31;

(b) a chemical safety report is not required to be completed by his supplier in accordance with Article 14;

(c) the downstream user uses the substance or ►M3 mixture ◄ in a total quantity of less than one tonne per year;

(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;

(e) the substance is present in a ►M3 mixture ◄ 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 purposes of product and process oriented research and development, provided that the risks to human health and the environment are adequately controlled in accordance with the requirements 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:

(a) the safety data sheet(s) supplied to him;

(b) his own chemical safety assessment;

(c) any information on risk management measures supplied to him in accordance with Article 32.

6. Where a downstream user does not prepare a chemical safety report in accordance with paragraph 4(c), he shall consider the use(s) of the substance and identify and apply any appropriate risk management measures needed to ensure that the 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 with paragraph 4 of this Article need not include consideration of the risks to human health from the end uses set out in Article 14(5).

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:

(a) the downstream user has to prepare a chemical safety report in accordance with Article 37(4); or

(b) the downstream user is relying on the exemptions in Article 37(4)(c) or (f).

2. The information reported by the downstream user shall include the following:

(a) his identity and contact details as specified in Section 1.1 of Annex 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) or other 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);

(f) except where the downstream user is relying on the exemption in Article 37(4)(c), a proposal for additional testing on vertebrate animals, where this is considered necessary by the downstream 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 ►M3 mixture ◄ , used by the downstream user in quantities of less than one tonne per year for that particular use.

Article 39

Application of downstream user obligations

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







TITLE VI

EVALUATION







CHAPTER 1

Dossier evaluation

Article 40

Examination of testing proposals

▼M3

1. The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X