Division 1.2 Weight of evidenceX1F1
United Kingdom
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.
Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available:
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further testing on vertebrate animals for that property shall be omitted,
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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.
Annotations
Textual amendments
- F1
- F2
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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)