CIRS Group
Medical Devices
C&K Testing
Carbon Neutrality
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.
The European Commission has discussed about the revised draft guidance documents for intermediates submitted by ECHA. The revised draft give a more specific definition on intermediates and the identification of intermediates also become stricter.
In 2021, ECHA conducted 371 compliance checks covering more than 2100 registration dossiers and addressing 341 substances. 300 of these checks were so called full compliance checks, addressing all relevant endpoints of substances of potential concern. They resulted in 280 draft decisions (about 93%) sent to companies, requesting more data to clarify long-term effects on human health or the environment.
The European Commission launched a public consultation on the revision of the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) on 20 Jan. 2022. The planned REACH revision is one of the actions announced in the Chemicals Strategy for Sustainability. The consultation will run until mid-April 2022.
The European Commission has revised certain information requirements for registering chemicals under REACH, which will start to apply from January 2022. The regulation on amending Annex Annexes VII to XI under REACH was released on 17 June 2021. It clarifies the information companies need to submit in their registrations and makes ECHA’s evaluation practices more transparent and predictable The main changes concern: Requirements for surface tension and water solubility of
ECHA has published the Community Rolling Action Plan (Corap) for the Years 2021, 2022 and 2023. A total of 58 substances are subject to evaluation by the Member State competent authorities under the substance evaluation process of the REACH Regulation (EC) No 1907/2006 (Articles 44 to 48). Among the 58 substances, 3 substances are newly allocated while the other 55 substances were published in the previous Corap update on 18 March 2020. These substances are distributed for e