A public consultation launched on 19 October by the European Commission is running until 16 November on a draft regulation to amend the annexes of the REACH Regulation (1907/2006) on the Registration, Evaluation, Authorisation and Restriction of Chemicals.
The aim is to clarify unclear or inconsistent wording and to update data requirements so that endocrine disrupters can be more easily identified and assessed, the Commission stresses.
Annexes VII to X set out, respectively, the standard information requirements for substances manufactured or imported in quantities of one tonne or more, 10 tonnes or more, 100 tonnes or more or 1,000 tonnes or more.
Annex XI lays down the general rules for adapting the standard assessment regime set out in Annexes VII to X.
In the June 2019 assessment of REACH, the European Commission and the European Chemicals Agency (ECHA) concluded that the annexes needed to be amended to provide greater clarity on the obligations of registrants and the role and responsibilities of the ECHA.
Among other changes, the provisions on toxicological information in Annex IX require some clarification to specify when a sub-chronic toxicity study is not required.
In addition, it is necessary to amend the specific rules laid down in Annexes IX and X about adaptation for the reproductive toxicity studies in order to better specify the cases where testing does not need to be conducted.
It is also necessary to clarify how to demonstrate low toxicological activity of a substance in order to adapt testing. Lastly, the provision setting out the conditions under which no further testing is necessary for sexual function and fertility or developmental toxicity should be simplified.
The Commission’s consultation is open to comments from interested parties until 16 November. (Original version in French by Aminata Niang)