CIRS Group
Medical Devices
C&K Testing
Carbon Neutrality
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.
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.
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.
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').
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.
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.
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.
On 11 Apr. 2022, the European Commission has added 5 substances into the Authorised List by adopting the Commission Regulation COMMISSION REGULATION (EU) 2022/586 of 8 April 2022 regarding amending Annex XIV to REACH Regulation. This amendments will take effect from 1 May 2022.
On April 6 2022, ECHA and the Member States have assessed a group of 148 bisphenols and recommended that more than 30 bisphenols need to be restricted due to their potential hormonal or reprotoxic effects. Many bisphenols are known endocrine disrupters both for human health and the environment and may lead to exposures to both professionals and consumers. Bisphenols are mostly used as intermediates in the manufacture of polymers or polymer resins, such as polycarbonate plastics and epoxy resins and hardeners. They are also used in thermal paper, inks and coatings, adhesives, textiles, paper or in board. As they are widely used, a group restriction has been identified as the best way to manage the risks of 34 bisphenols.
As one of the most influential chemical regulations around the world, the REACH Regulation has been implemented for more than 15 years. However, the REACH Regulation is still constantly improved and revised. CIRS warmly reminds that related enterprises should still pay close attention to the Regulation so as to ensure the business trade with EU goes smoothly.