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The European Commission has recently published regulation (EU) 2023/464, which amends the Annex to Regulation (EC) No 440/2008, a set of test methods under the Registration, Authorization and Restriction of Chemicals (REACH) regulation. In this amendment, a number of new OECD in vitro test methods are introduced while some old test methods are removed such as Two-Generation Reproduction Toxicity Study (OECD 416) and Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo (OECD 486), which promotes the application of in vitro test methods in the EU.
On March 31, 2023, the European Commission released the amendments to Annex I to Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (CLP), introducing several new classification criteria to identify endocrine disrupting chemicals (EDCs) and persistent and mobile substances.
Starting from 2023, the amendments to Annex II of REACH regulation on safety data sheets (SDSs) became mandatory. This means that related enterprises must affix a unique formula identifier (UFI) code in section 1.1 of their SDS when exporting mixtures to the EU. Mixtures that meet specific conditions must also complete poison center notification (PCN).
The European Commission is preparing an amending act proposing to introduce new hazard classes for endocrine disruptors in the CLP Regulation (EC No. 1272/2008). Within one year of the entry into force of the amending act, the EU Commission shall ask European Chemicals Agency (ECHA) to assess whether resorcinol meets the class of endocrine disruptors and whether it should be identified as a substance of very high concern (SVHC).
The Committee for Risk Assessment (RAC) has adopted opinions and amendments to Annex VI to the CLP regulation, with 39 new entries added, 17 entries amended and 1 entry deleted. This amended Regulation shall enter into force on May 3, 2022, and will be implemented from November 23, 2023.