2. Regulation of Chemicals

Abstract

This year, some of the annexes to EC Regulation 1907/2006 Concerning the Regulation, Evaluation, and Authorization of Chemicals (REACH Regulation) were amended, and case law emerged. Outside of the REACH Regulation, a certain substance was approved as an active substance for use in biocidal products, and the commission decided on its position to be taken in negotiations about the Stockholm Convention on Persistent Organic Pollutants (Stockholm Convention). EU Regulation 2015/282 amends Annexes VIII, IX and X to the Reach Regulation, specifying the scope of a new modular test method called the extended one-generation reproductive toxicity study (EOGRTS), which was adopted by the Organisation for Economic Co-operation and Development in 2011. According to the current amendment, a two-generation reproductive toxicity study is regularly required to fulfil the standard information requirements in point 8.7.3 of Annexes IX and X. However, under EOGRTS, breeding and assessment of a second filial generation and testing for developmental neurotoxicity and developmental immunotoxicity constitute distinct and independent modules (Commission Regulation (EU) 2015/282, preamble, para. 3). EOGRTS focuses on the analysis of the first filial generation and addresses additional parameters in the hope of improvements in sensitivity and the level of information that can be gained from the tests.