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REACH
On October 15, 2024, Brazil's Senate approved Bill No. 6120 of 2019, a REACH-like chemical management bill aimed at establishing a national registry of chemical substances. This bill mandates a comprehensive assessment and risk control of chemicals used, produced, or imported within the country to minimize adverse impacts on human health and the environment.
Six substances added to the SVHC Candidate List; 22 chemical substances set for upcoming REACH registration testing approval; public consultations launched on CLH proposals for two chemicals.
QCOs implementation date postponed from August 25, 2024, to December 24, 2024.
Feedback is welcome until September 16, 2024.
On July 23, 2024, the Ukrainian government approved the Ukrainian Technical Regulation on Chemical Safety, modeled after EU REACH. This requires the registration of chemical substances produced or imported over one ton annually. The regulation becomes effective on January 23, 2025, six months after its approval.
The Ministry of Environment Protection and Natural Resources of Ukraine has issued the Ukraine REACH Resolution - "On the Approval of Technical Regulations on the Safety of Chemicals" and is open for comments as of March 22, 2024. The Ukraine REACH draft, identical to the one submitted to the World Trade Organization in 2023, establishes the Ukrainian chemical legislative framework and aims to align Ukraine's chemical safety regulations with EU standards. Foreign companies that are importers, manufacturers or represented by a local sole representative, companies that sell chemicals (substances/mixtures) on the Ukrainian market, as well as downstream users of these chemicals will be affected by Ukraine REACH.
The Measures on the Environmental Management Registration of New Chemical Substances (MEE Order 12) were implemented two years ago on January 1, 2021. It has not only optimized and adjusted the registration types and relevant data requirements to lessen the burden on enterprises, but also focused on environmental risk prevention and control for new chemical substances with high environmental risks. In addition, MEE Order 12 has specified the registration standards and improved the approval requirements for new chemical substances in the review and evaluation, stating the specific circumstances for approval, disapproval, reapplication, change, withdrawal, and revocation of registrations.
On November 23, 2022, Bill PL 6120/2019 was approved by the Commission of Economic Development, Industry, Trade, and Commercial Services (CDEICS) of the Brazilian Chamber of Deputies and has been submitted to the Commission on Constitution, Justice and Citizenship (CCJS) for further review. If the Bill successfully passes the review, it will act as the Brazilian REACH Regulation. Domestic enterprises involved in exporting chemicals to Brazil should pay close attention to the Bill. If the Bill becomes law, Brazil will become the third country in South America, to set up chemical management rules, after Chile and Colombia.
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.
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.