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Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilShow full title
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)
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- Revised 27/06/20091.27 MB
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- Revised 12/10/20081.20 MB
- Revised 23/11/20071.15 MB
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[X1 Article 13 U.K. 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. [F1The Secretary of State,] following consultation with relevant stakeholders, shall, as soon as possible, make a proposal, if appropriate, to amend the [F2Test Methods Regulation] , and the Annexes of this Regulation, if relevant, so as to replace, reduce or refine animal testing. [F3Amendments to the Test Methods Regulation may be made by regulations made by the Secretary of State. Amendments to the Annexes of this Regulation may be made by regulations made by the Secretary of State. Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament. The functions of making regulations under this paragraph are subject to the consent requirement in Article 4A.]
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 [F4the Test Methods Regulation] or in accordance with other international test methods recognised by F5... the Agency as being appropriate. F6...
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 [F7the Good Laboratory Practice Regulations 1999] or other international standards recognised as being equivalent by F8... the Agency and with the provisions of [F9the Animals (Scientific Procedures) Act 1986] , 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. ]
[F106. In this Article “ Test Methods Regulation ” means Commission Regulation (EU) No 440/2008.]
Editorial Information
X1Substituted by Corrigendum to 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 (Official Journal of the European Union L 396 of 30 December 2006).
Textual Amendments
F1 Words in Art. 13(2) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 12(2)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
F2 Words in Art. 13(2) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 12(2)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F3 Words in Art. 13(2) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 12(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
F4 Words in Art. 13(3) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 12(3)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
F5 Words in Art. 13(3) omitted (31.12.2020) by virtue of The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 12(3)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F6 Words in Art. 13(3) omitted (31.12.2020) by virtue of The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 12(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F7 Words in Art. 13(4) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 12(4)(a); 2020 c. 1, Sch. 5 para. 1(1)
F8 Words in Art. 13(4) omitted (31.12.2020) by virtue of The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 12(4)(b); 2020 c. 1, Sch. 5 para. 1(1)
F9 Words in Art. 13(4) substituted (31.12.2020) by virtue of The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 12(4)(c); 2020 c. 1, Sch. 5 para. 1(1)
F10 Art. 13(6) inserted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 12(5); 2020 c. 1, Sch. 5 para. 1(1)
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