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In January 2022, the RCEP Agreement entered into force, covering 10 ASEAN countries, China, Japan, South Korea, Australia and New Zealand. After RCEP comes into effect, more than 90% of the trade of goods in the region will eventually achieve zero tariffs, which involves the chemical industry with more than 1,000 tariff numbers of RCEP origin rules, benefiting the import and export trade of chemicals. Within the RCEP coverage, most countries, including China, have adopted GHS classification and labelling systems, which requires the Safety Data Sheet (SDS) and labels of chemicals to comply with the GHS-related regulations and standards of each country and region.
In health toxicology study, in vitro methods usually utilizes isolated organs, in vitro cultured bacteria, cells or organelles, and biological simulations in the laboratories to refine, reduce and replace traditional animal tests. In vitro methods are developed to protect animal welfare, which is a major focus in testing currently. At present, in vitro methods for skin corrosion/irritation, eye irritation, and skin sensitization have been greatly developed, and have been applied in EU REACH registration. China is also advancing the application of in vitro methods step by step. For example, under the previous Measures for Environmental Management of New Chemical Substances (MEE Order No.7), positive results generated by in vitro skin corrosion/ irritation and eye irritation methods are accepted.
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.
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.
3 March 2022, China MEE announced that the ninth batch of 18 substances have fulfilled the requirements for IECSC supplementation and will be managed as existing chemical substances. CIRS warmly reminds that related enterprises must make sure whether their substances are existing substances. The Provisions on Environmental Administration of New Chemical Substances (MEE Order No. 12) require enterprises to complete new substance registration/record before manufacturing or importing, or they may face various punishments. To find whether the substance is existing substance, please search CIRS APCISS system.
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 Provisions on Environmental Administration Registration of New Chemical Substances (MEE Order No. 12) has been implemented for over a year. It has attracted extensive attentions from related enterprise. However, as the data requirements for regular registrations under MEE Order No. 12 are higher than that of MEP Order No. 7, only 11 batches of approved regular/simplified registrations, which includes 38 simplified registrations and 1 regular registration (record not excepted), have been notified.
On 23 Nov. 2021, Taiwan has released the Revised Regulation on New and Existing Chemical Substances Registration (Regulation), which took effective from the date of promulgation. The Regulation on New and Existing Chemical Substances Registration was prepared based on the Toxic and Concerned Chemical Substance Control Act. It specifies the data requirements when registrants go through the registration process for the manufacture or import of new and existing chemical substances. On 11 Mar. 2019, Taiwan EPA has amended the Regulation for the first time. In the first revision, the Regulation listed 106 substances as the first batch of existing substances subject to standard registration, and gave their tonnage band, registration deadlines, as well as the data requirements. This is the second revision to the Regulation.
CIRS has launched the Joint Submission and Data Sharing Platform for New Chemical Substance (China SIEF) to help related enterprises significantly reduce the compliance costs for new chemical substance registration in China. Through this platform, you may: Search the information of the registered substances as well as the enterprise information; Significantly reduce the registration fee through joint submission and data sharing; and Reduce the compliance cost by selling data
China Ministry of Ecology and Environment announced that 255 substances have fulfilled the requirements under Measures for the Environmental Management Registration of New Chemical Substances and have been supplemented into China Existing Chemical Substance Inventory. These substances will be managed as existing substances. CIRS warmly reminds that related enterprises must make sure whether their substances are listed in IECSC. If their substances are not existing substance,