The European Union (EU) has signalled its intention to revise Regulation (EC) No. 1272/2008 on Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation) via two draft regulations. If accepted, the changes will affect several boron-containing compounds and 2-ethylhexanoic acid and its salts.
Proposed changes include:
- Draft Regulation 1 – revision to Part 1 in Annex VI of the CLP Regulation by adding Note X to section 184.108.40.206 and Notes 11 and 12 to section 220.127.116.11
- Note 11 is only assigned to certain boron compounds – the classification of mixtures as reproductive toxicant is necessary if the sum of the concentrations of individual boron compounds that are classified as reproductive toxicant in the mixture as placed on the market is greater than or equal to 0.3%
- Draft Regulation 2 – replaces six index number entries in Part 3, Table 3 to Annex VI, of which five index number entries are related to boron-containing compounds and each of these five entries contains Note 11, as well as the index entry on 2-ethylhexanoic acid and its salts with Notes A, X and 12
The World Trade Organization (WTO) announced the two draft regulations in June and July 2022. According to the documents, it is proposed that Draft Regulation 1 will be adopted in September 2022, coming into force 20 days after publication in the Official Journal of the EU (OJEU). Draft Regulation 2 will probably be adopted in Q4 of 2022 and brought into force 20 days after publishing in the OJEU. It will then come into effect 18 months later.
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