Excerpt
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 -МЗ 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
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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 reexportation, 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 Council10 ;
(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.
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
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);
(b) it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004 or on 1 January 2007, 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 or on 1 January 2007, 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;
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; 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.[2]
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 recollected for disposal after the exemption period.
In such cases, the Agency may ask the notifier to provide additional necessary information.[3]
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.[4]
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.[5]
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.[6]
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
file kr at - M3 mixture ? or in an article or a group of substances.
2. A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a
- M3 mixture ? if the concentration of the substance in the
- M3 mixture ? is less than the lowest of any of the following:
(a) the applicable concentrations defined in the table of Article 3(3) of Directive 1999/45/EC;
- M3
(b) the specific concentration limits that have been set in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (');
(ba) for substances classified as hazardous to the aquatic environment, if a multiplying factor (hereinafter referred to as ‘M-factor’) has been set in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the cut-off value in Table 1.1 of Annex I to that Regulation adjusted using the calculation set out in section 4.1 of Annex I to that Regulation;
- Ç1
(c) the concentration limits given in Part B of Annex II to Directive 1999/45/EC;
(d) the concentration limits given in Part B of Annex III to Directive 1999/45/EC;
- M3
(e) the specific concentration limits given in an agreed entry in the classification and labelling inventory referred to in Article 42 of Regulation (EC) No 1272/2008;
(ea) for substances classified as hazardous to the aquatic environment, if an M-factor has been set in an agreed entry in the classification and labelling inventory referred to in Article 42 of Regulation (EC) No 1272/2008, the cut-off value in Table 1.1 of Annex I to that Regulation adjusted using the calculation set out in section 4.1 of Annex I to that Regulation;
- Ç1
(f) 0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII of this Regulation.
3. A chemical safety assessment of a substance shall include the following steps:
(a) human health hazard assessment;
(b) physicochemical hazard assessment;
(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:
- Ç1
(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.[7]
(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 ([8] );
(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 ([9] ) or in Commission Regulation (EEC) No 3600/92 ([10] ), Commission Regulation (EC) No 703/2001 ([11] [12] ), Commission Regulation (EC) No 1490/2002 (5), or Commission Decision 2003/565/EC ([13] ) 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 (*) or in Commission Regulation (EC) No 2032/2003 (2) on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC, until the date of the decision referred to in the second subparagraph of Article 16(2) of Directive 98/8/EC, shall be regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product 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;
C) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive 2006/140/EC (OJ L 414, 30.12.2006, p. 78).
(2) OJ L 307, 24.11.2003, p. 1. Regulation as last amended by Regulation (EC) No 1849/2006 (OJ L 355, 15.12.2006, p. 63).
(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 regis- trant(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;
[...]
1 OJ L 159, 29.6.1996, p. 1.
2 OJ L 114, 27.4.2006, p. 9.
3 OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC) No 1882/2003.
4 OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council (OJ L 33, 4.2.2006, p. 1).
5 OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).
6 OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).
7 OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006.
8 OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003.
9 OJ L 184, 15.7.1988, p. 61. Directive as last amended by Regulation (EC) No 1882/2003.
10 OJ L 84, 27.3.1999, p. 1. Decision as last amended by Decision 2006/253/EC (OJ L 91, 29.3.2006, p. 48).
11 OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).
12 OJ L 213, 21.7.1982, p. 8. Directive as last amended by Commission Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81).
13 OJ L 124, 20.5.2003, p. 36.
- Quote paper
- Stefanie Merenyi (Author), 2012, REACH: Regulation (EC) No 1907/2006, Munich, GRIN Verlag, https://www.grin.com/document/203248
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