ECHA Consults on Recommending 5 Substances for REACH Authorisation
The European Chemicals Agency (ECHA) is considering recommending five substances for the REACH Authorisation List. These five substances cover: Melamine; Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (TBPH); S-(tricyclo[22.214.171.124 2,6]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate; Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide; and Barium diboron tetraoxide.
ECHA Proposes to Restrict Three Benzotriazoles under REACH
On 18 January 2024, ECHA published a screening report to assess whether the use of these four benzotriazoles in articles, including UV-328, UV 327, UV-350, and UV-320, should be restricted in accordance with REACH Article 69(2). Based on the available evidence, ECHA is considering restricting or prohibiting the use (or presence) of three out of the four substances, including UV-320, UV-350, and UV-327 in articles and preparing an Annex XV dossier for restriction. In terms of UV-328, ECHA is of the view that at present there is no need to prepare an Annex XV dossier for restriction as the substance is expected to be addressed by the EU POPs regulation.
ECHA Adds Five Substances into the Candidate List of SVHCs
Helsinki, January 23, 2024 – The European Chemicals Agency (ECHA) officially announced the addition of two substances of very high concern (SVHC), bringing the total number of substances on the SVHC list (also known as the Candidate List) to 240. ECHA has also updated the existing Candidate List entry for dibutyl phthalate to include its endocrine-disrupting properties for the environment. Dibutyl phthalate (DBP) was added to the SVHC Candidate List in October 2008 in the first batch.
EU to Remove Chromium (VI) Oxide from the Authorisation List
On September 27, 2023, ECHA was mandated to prepare an Annex XV report for possible restriction of chromium substances (CrVI). ECHA should submit a restriction proposal by October 4, 2024. This restriction proposal intends to improve the effectiveness and management of chromium (VI) substances in the European Union.
ECHA’s Enforcement Forum Starts to Publish its Advice on Enforceability of REACH Restrictions
On September 13, 2023, the European Chemicals Agency's (ECHA) Enforcement Forum decided to make its advice on the enforceability of REACH restriction proposals public. It officially published its first advice on the proposal to restrict creosote and related substances in treated wood.
The Use of Formaldehyde and Formaldehyde-releasing Substances will be Restricted under REACH
On July 17, 2023, the European Union published Regulation (EU) 2023/1464 to amend the REACH Regulation by introducing a new restriction – Article 77, which specifically addresses formaldehyde and formaldehyde-releasing substances in Annex XVII of the REACH Regulation. This new provision will come into effect 20 days after its publication in the Official Journal of the European Union. This update can be seen as a comprehensive control measure by the EU to regulate formaldehyde, and the scope of applicable products is no longer limited to those containing boards; it now encompasses almost all lightweight consumer products, including furniture, toys, baby and children's products, tools, stationery, fitness equipment, pet supplies, and sanitary products, among others.
EU Court of Justice Annuls Authorization for Chromium Trioxide
On April 20, 2023, the EU Court of Justice (ECJ) annulled the authorization of chromium trioxide in its manufacture process as to its concerned uses in the following: formulation of mixtures ('category 1'); functional chrome plating ('category 2'); functional chrome plating with decorative character ('category 3'); surface treatment for applications in the aeronautics and aerospace sectors (unrelated to functional chrome plating with decorative character) ('category 4'); surface treatment (except passivation of tin-plated steel (electrolytic tin plating – ETP)) for applications in various industry sectors, namely architectural, automotive, metal manufacturing and finishing, and general engineering (unrelated to functional chrome plating or functional chrome plating with decorative character) ('category 5'); and passivation of tin-plated steel (ETP) ('category 6').
EU Vigorously Advances Animal Testing Alternatives, OECD 416 and UDS Removed
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.
ECHA Recommends Eight Substances for REACH Authorisation
To protect workers and the environment, ECHA recommends adding eight substances, including lead, to the REACH Authorisation List. Once substances are added to the REACH Authorisation List, companies will need to apply for authorization before a specific date to continue using them.
Interpretation on How to Properly Adopt Read-across Approach during Substance Registration and Matters Need Attention
As one of the most frequently used alternative methods for hazard assessment, the read-across approach has been widely adopted in chemical registration in many counties and regions. Take new substance registration in China for example, read-across is widely used in serial registration. When carrying out serial registration, enterprises shall provide physicochemical data of each substance as well as a complete set of data that consists of health toxicological data and eco-toxicological data of new substances in the group. Besides, enterprises should submit at least one same health toxicological and ecotoxicological data for each new substance.