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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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There may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or has not a particular dangerous property, while the information from each single source alone is regarded insufficient to support this notion.
There may be sufficient weight of evidence from the use of newly developed test methods, not yet included in the test methods referred to in Article 13(3) or from an international test method recognised by F2 ... the Agency as being equivalent, leading to the conclusion that a substance has or has not a particular dangerous property.
Textual Amendments
F2 Words in Annex 11 point 1.2 omitted (31.12.2020) by virtue of The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 3 para. 8(2); 2020 c. 1, Sch. 5 para. 1(1)
Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available:
further testing on vertebrate animals for that property shall be omitted,
further testing not involving vertebrate animals may be omitted.
In all cases adequate and reliable documentation shall be provided.
When nanoforms are covered by the registration the above approach shall address the nanoforms separately.] ]
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 Substituted by Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (Text with EEA relevance).
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