On October 19, 2020, the European Commission (EC) opened a consultation on the draft amendment to the “Annexes VII to XI to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).” The Annexes VII to X deal with information requirements for registered substances, defined according to their tonnages, and Annex XI “sets out the general rules for adaptation of the standard testing regime set out in Annexes VII to X thereto.”
As summarized by the EC, the purpose of the proposed amendment was “to clarify unclear or inconsistent wording and to update data requirements so that endocrine disruptors, which can have harmful effects on the body’s endocrine (hormone) system, can be more easily identified and assessed.” The amendment’s text, however, does not specifically refer to endocrine disrupting chemicals (EDCs).
Overall, “23 individual changes, ranging from the addition of a few words or phrases to the substitution of multiple paragraphs,” are proposed, which cover “multiple topics relating to physicochemical and toxicological properties,” as summarized in an article by Chemical Watch, published on October 22, 2020. For example, the amendment specifies the conditions when studies on sub-chronic toxicity, sexual function, fertility, or developmental toxicity could be waived or simplified, and proposes “adaptations of the reproductive toxicity studies” as well as a possibility for “the waiving of studies on fate and behavior in the environment on the sole basis of a low octanol-water partition coefficient.” In addition, there are new specifications regarding “use of existing data, weight of evidence approaches and grouping of substances” as well as “structural similarity in the context of read across.”
Comments are being accepted until November 16, 2020. The proposed adoption is set for the fourth quarter of 2020, and changes in the information requirements would apply from six months after the amendment’s entry into force.
European Commission (October 19, 2020). “Chemicals – clarification of requirements for registering, evaluating, authorizing and restricting chemicals.”
Chemical Watch (October 22, 2020). “European Commission consults on proposed ‘clarifications’ to REACH information requirements.”