Grouping of substances and read-across to establish structural similarity between substances as an alternative to testing is gaining traction in many regulatory fields such as medical devices, biocides, pesticides, chemicals and cosmetics. The grouping and read-across approach is described in REACH Annex XI, Section 1.5.
The amendments in Section 1.5, which have applied since January 2022, are described in more detail in a recently published ECHA Advice on using read-across for UVCB substances.
- Section 2 of the advice explains the basis for establishing structural similarity specifically for substances of unknown or variable composition or biological origin (UVCBs).
- Sections 3 and 4 set out the conditions to be fulfilled by a grouping and read-across adaptation, including the supporting documentation that needs to be provided.
It should be noted that the advice on documentation is relevant for all substances and not specific to UVCBs.
For expert advice on grouping and read-across, please consult:
Brian Svend Nielsen
bsn@dhigroup.com
Tel +45 4516 9140
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