May 4th 2017 saw the publication of Commission Regulation 2017/776 in the Official Journal of the European Union. This document – informally known as the 10th ATP (Adaptation to Technical Progress) to CLP – includes some updated and new harmonised classifications.
You may remember us informing you of the release of the 9th ATP to CLP in July 2016, which brought about some significant changes to the CLP Regulation. The 10th ATP also contains a number of important updates to the legislation:
What Changes Are In The 10th ATP To CLP?
- Harmonised ATEs
Perhaps most notably, a new concept of harmonised ATEs (Acute Toxicity Estimates) has been introduced, with Nicotine (CAS 54-11-5) being the first substance on Annex VI to have harmonised ATEs for the various routes for Acute Toxicity. ATEs are mainly used to determine the classification for human health acute toxicity of mixtures containing substances classified for acute toxicity. The inclusion of these harmonised ATE values will facilitate the harmonisation of classifying mixtures as a whole, which will in turn provide support for enforcement authorities.
The ATE values are to be harmonised in accordance with Article 37 of CLP, and these values will be added to the penultimate column of Table 3.1 of Part 3 of Annex VI. However, it should be noted that Table 3.1 is soon to be renamed Table 3, due to the removal of Table 3.2 from Annex VI – which was announced in the 9th ATP, but becomes effective on 1st June 2017.
- Other Notable Amendments
Other amendments to Annex VI include changes to the introductory paragraphs, further explanations on when the harmonised ATEs should be applied, and various amendments to the Notes included in the Annex.
The harmonised classifications within the 10th ATP will apply from December 1st 2018, with the other parts being applied on 1st June 2017 when the removal of Table 3.2 takes effect.
If your company places chemical substances and chemicals mixtures on the market, it is advised that you review how they might be affected by the changes to Annex VI, to ensure that your products are ready in time for December 2018.
Contributors to this article include Dr. Amy Lawrence, MChem, PhD (Synthetic Organic Chemistry), who is part of the Consultancy Team at Safeware Quasar. Our dedicated team of in-house regulatory experts have a comprehensive understanding of chemical regulations across the globe, and are constantly monitoring these regulations to help hundreds of companies in the chemical sector comply with the complex and ever-evolving chemical legislation.