EU REACH: Upcoming Changes to Information Requirements

On April 12, 2022, the European Chemicals Agency(ECHA) published the news that the European Commission has revised certain information requirements for registering chemicals under EU REACH. Companies should start to prepare as the changes will begin to apply in October 2022. ECHA will publish further advice later this year. The update of the EU REACH annexes clarifies the information companies need to submit in their registrations and makes ECHA’s evaluation practices more transparent and predictable. The changes will start to apply from 14 October 2022. Companies should get familiar with the updated annexes and prepare to review their registration dossiers. The main changes concern: Requirements and specific rules for adaptation of: in vitro and in vivo mutagenicity studies, specifying when further studies are needed based on mutagenicity concerns; reproductive toxicity studies, specifying the preferred animal species and administration routes, and clarifying the conditions triggering the need for further studies based on concerns; aquatic…

Apr. 20th, 2022

UK REACH: UK HSE Published Rolling Action Plan (RAP)

In March, 2022, the UK Health and Safety Executive(HSE) published the rolling action plan for UK REACH, including 2 substances for evaluation in 2022. In accordance with Article 44 of UK REACH and the criteria outlined in the document \’Approach to substance evaluation in UK REACH\’, the substances listed in table 1 are proposed for inclusion in the rolling action plan (RAP). In the approach to substance selection, UK HSE has sought to complement rather than replicate evaluation work that has been or will be performed by other regulatory regimes (such as via EU REACH). The intention is to increase the overall understanding of the hazard and risk profile of the priority substances and their relevance to GB. The selection of substances for inclusion in the RAP is based on the hazard profile of substances and their exposure potential, including the quantities that are supplied. The Agency will consider information…

Apr. 12th, 2022

Chemical Regulatory Updates in Asia-Pacific Region | March 2022

Chinese Mainland China Cancels Filing of Imported Coatings, Custom Inspection Still Required (March 1, 2022) On March 1, 2022, China\’s General Administration of Customs (GAC) issued Order No. 257, announcing the repeal of several regulations including the Measures for the supervision and administration of inspection of imported coatings. The Order was effective immediately. (CL news)   China MEE Adds 18 Substances into IECSC (March 3, 2022) On March 3, 2022, the Chinese Ministry of Ecology and Environment (MEE) published a notice, announcing the addition of 18 substances into the Inventory of Existing Chemical Substances (IECSC). These substances were previously registered under the Measures on Environmental Management of New Chemical Substances (MEP Order No. 7 of 2010), and now are qualified for listing into the IECSC as existing chemical substances in China. (Read More)   China Consults on RoHS Related Standard on Determination of Seven Phthalates (March 3, 2022) On March…

Apr. 11th, 2022

U.S. EPA Issues Additional Test Orders to Support Risk Evaluation under TSCA

The U.S. Environmental Protection Agency (EPA) has issued a second round of test orders under section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. After reviewing reasonably available data on these chemicals, U.S. EPA has determined additional data are needed and is using its U.S. TSCA test order authority to require companies to develop and submit information on avian and aquatic environmental hazard and consumer exposure. This action marks the third time EPA has used its new authority to issue test orders under section 4 of amended U.S.  TSCA. In January 2021, U.S.  EPA issued test orders for the same eight chemicals, requiring testing on aquatic environmental hazard and inhalation and dermal exposures for workers. The information obtained through these orders will help ensure EPA’s risk evaluations for these chemicals are robust, credible, and use the best available data….

Mar. 31st, 2022

EU REACH: EU Member States plan to evaluate 27 substances in 2022-2024

The European Chemicals Agency(ECHA)  lists 27 substances for evaluation by EU Member States under the Community rolling action plan (CoRAP) for 2022-2024. Four of the substances are planned to be evaluated in 2022, while 23 substances are listed for evaluation in 2023 and 2024. Based on the opinion of its Member State Committee, ECHA adopted and published the CoRAP for 2022-2024 on 22 March 2022. Registrants should check if their dossiers need to be updated with new relevant information, for example, on hazard, tonnages, use and exposure. Community rolling action plan update covering the years 2022, 2023 and 2024 The Community rolling action plan (CoRAP) update for the years 2022–2024 lists 27 substances suspected of posing a risk to human health or the environment, for evaluation by 10 Member State competent authorities, under the substance evaluation process of the REACH Regulation (EC) No 1907/2006 (Articles 44 to 48). The plan contains two newly allocated substances…

Mar. 31st, 2022

China Issues 14th Five-Year Plan (2021-2025) for Safe Production of Hazardous Chemicals

On March 21, 2022, the Chinese Ministry of Emergency Management (MEM) issued the 14th Five-Year Plan (2021-2025) for Safe Production of Hazardous Chemicals (hereinafter referred to as the Plan), with the focus on accurately controlling the safety risks of hazardous chemicals in eight key industries, including chemical industry, pharmaceutical industry, oil and gas industry, firework industry, etc. The Plan outlines the major targets to ensure the safe production of hazardous chemicals, as well as fireworks and oil and gas during the 14th Five-Year Plan period. More specifically: By 2025 The major and severe accidents caused by hazardous chemicals will be effectively curbed. Compared with the 13th Five-Year Plan period, the number of chemical accidents and fatalities, as well as oil and gas accidents and fatalities, will decrease by more than 15%; the number of accidents and fatalities caused by the production/operation of fireworks and firecrackers will be dropped by more than 20%….

Mar. 24th, 2022

Long-awaited India REACH to be Released in Months

According to insider sources, India’s Chemicals (Management & Safety) Rules (CMSR), which is dubbed “India REACH” will be notified to the WTO in May or June and took effect in August this year. CMSR has been drafted for years and its fifth draft was issued in August 2020 (CL news). The legislation slowed down last year due to Covid-19. The industry also voiced their strong wishes to postpone its implementation since they need more time to recover from the impact of the unprecedented epidemic. ChemLinked learnt from the authority that the CMSR now turns into a highly prioritized legislation task. Several discussions are going on to speed up its legislation this year. In addition, the IT system for dossier preparation and submission is under development, which is similar to IUCLID under EU REACH. “SIEF-like” functions will be incorporated to help find co-registrants for joint registration. As planned, CMSR will be notified to the…

Mar. 17th, 2022

China MEE Adds 18 Substances into IECSC

On March 3, 2022, the Chinese Ministry of Ecology and Environment (MEE) published a notice, announcing the addition of 18 substances into the Inventory of Existing Chemical Substances (IECSC). These substances were previously registered under the Measures on Environmental Management of New Chemical Substances (MEP Order No. 7 of 2010), and now are qualified for listing into the IECSC as existing chemical substances in China. Details of these substances can be accessed here, including chemical name (both in Chinese and English), CAS number or Serial number, molecular formula, and permitted uses (if subject to new usage environmental management). They are now regulated as existing chemical substances in China, and thus free from new chemical registration or notification requirements under the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12). However, if the substance is used for industrial applications other than the permitted uses, new usage registration will be required.

Mar. 17th, 2022

New Hazchem Registration Online System to be Implemented Nationwide in 2022

On January 5, 2022, the Work Safety Committee of the State Council issued the National Plan for Centralized Management of Safety Risks of Hazardous Chemicals[1]. The plan proposes to enhance the digital and intelligent management of hazardous chemicals. The Emergency Management Department shall be responsible for promoting the upgrading of chemical registration system.  “One enterprise, one chemical product, and one QR code” management shall be imposed to achieve efficient hazardous chemical information transfer through the whole life cycle. The existing online registration system was launched by NRCC, the National Registration Center for Chemicals in July of 2013. In July, 2021, NRCC upgraded its registration platform and piloted it in Guangdong Province. Under the new system, there are some new requirements in applicants and obligations. More enterprises, in addition to Hazchem manufacturers and importers (obliged for Hazchem registration, same as before), will be covered to report Hazchem information, including the operators that have obtained Hazchem…

Jan. 17th, 2022

India Expects to Notify WTO of Draft CMSR This Year

India’s national chemical management policy has been in the spotlight since the unveiling of the fifth draft of the Chemicals (Management and Safety) Rules (CMSR) in August 2020.So when Mr. Shisher Kumra, representing Global Product Compliance Group, one of the only two non-governmental organizations involved in reviewing the regulation gave his speech at the CRAC-HCF 2021 Virtual Forum held by REACH24H on November 11, 2021, a lot of attention was drawn. Mr. Shisher Kumra in his speech firstly introduced the fifth draft of CMSR (Details can be accessed here). The authority has encountered many problems in developing and improving CMSR as it is a huge deviation from current practices. Although CMSR will bring in new obligations, e.g. chemical notification, registration and annual reporting, the requirements on safety and accident preparedness as stipulated in Chapter IV remains unchanged compared with the Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 and the Chemical Accidents (Emergency Planning, Preparedness,…

Nov. 16th, 2021
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