In an article published on November 30, 2017, regulatory news provider Chemical Watch reported that the European Commission (EC) published its delegated Regulation (EU) 2017/2100 setting out scientific criteria for the identification of endocrine disrupting chemicals (EDCs) in the field of biocidal products. The regulation was published on November 17, 2017 in the Official Journal of the European Union and will apply from June 7, 2018.
In October 2017, the European Parliament (EP) vetoed the EC’s proposal for similar EDC criteria in the field of plant protections products (FPF reported). However, the EP did not block the proposed EDC criteria for biocides, meaning that the criteria will be first applied under the biocidal products Regulation (EU) No 528/2012. “Eventually, they are expected to become applicable across other sectors of EU law such as cosmetics, toys and food contact materials,” Chemical Watch explained.
In the meantime, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) are preparing a draft guidance on the implementation of the EDC criteria, as reported by Chemical Watch on November 29, 2017. The two agencies intend to publish the draft guidance in early December 2017. The guidance will include a hazard assessment strategy for adverse estrogenic, androgenic, thyroid and steroidogenic (EATS) effects, Chemical Watch informed. Currently, ECHA and EFSA are processing more than 1,800 comments received during a consultation with EU Member State competent authorities, industry, and “public interest stakeholder organizations.” After publication of the draft guidance, a public consultation will run for eight weeks. The guidance is expected to be revised by March 2018 and finalized in May 2018.
Chemical Watch (November 30, 2017). “Biocides EDC criteria to apply from June.”
Chemical Watch (November 29, 2017). “Draft guidance on EDC criteria out ‘in early December.’”
Official Journal of the European Union (November 17, 2017). “Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council.” (pdf)