The process to publish the 'Appendix on recommendations for nanomaterials applicable to the Guidance on Registration and Guidance on Substance ID' is moving ahead where the latest version, shared with the September meeting of CARACAL is now publicly available (September version, pdf) at the ECHA Ongoing Consultation page. The final version of the Guidance is expected to be published before the end of the year.
There are only a few changes compared to the public June version of the guidance.
The biggest change is found on P21 (Line 17) where a new paragraph has been inserted related to provision of justification for why the hazard assessment can be performed jointly, i.e. why the hazard profile of all the nanoforms within the set is the same). The newly inserted text reads:
‘It should be noted that this is the case for all the information provided according to Annex VII-X. The submitted information need to be representative for each nanoform covered within the set. This includes information according to the new nanospecific endpoints like Annex VII point 7.14 bis Dustiness.’
There are also revised sentences inserted where the ‘The registrant must also submit the adequate and reliable scientific evidence on which this justification is based.'
