Bestao Review - Summary of China Reach Regulations and standards May 2021
China REACH refers to China's Measures for Environmental Management of New Chemicals, which is the first time that China systematically manages chemicals produced and imported in China. According to its relevant regulations, China implements a declaration and registration system before production and import for the environmental management of new chemical substances. New chemical substances produced or imported must, in accordance with the provisions of these Measures, make a declaration of new chemical substances before production or import, and apply for a registration certificate for environmental management of new chemical substances.
Order No. 12 was implemented on Jan. 1, 2021
Introduction of China Measures for Environmental Management of New Chemical Substances
China's Ministry of Environmental Protection issued Decree No.7 in Jan. 2010, namely the revised New Measures for Environmental Management of Chemical Substances (hereinafter referred to as the New Measures), which was officially implemented in Oct. 2010. Before the production or import of new chemicals, a declaration of new chemicals must be made and a registration certificate for environmental management of new chemicals must be obtained. There are many similarities between this regulation and EU REACH regulation.
On Apr. 29, 2020, the Ministry of Ecology and Environmental Protection issued the newly revised Measures for Registration of Environmental Management of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment), which will be implemented on Jan. 1, 2021. The Measures for Registration of Environmental Management of New Chemical Substances (Order No. 7 of the Ministry of Environmental Protection) issued by the former Ministry of Environmental Protection on Jan. 19, 2010 will be abolished at the same time.
Application scope
Under the Measures for Environmental Management of New Chemical Substances, chemicals which are not listed in The Inventory of Existing Chemical Substances in China (IECSC) are new chemical substances. (Click it for the query) The applicant shall perform the declaration obligation to the new chemical substance which is not listed in the IECSC. New chemical substances included in the preparation and intentionally released by products are listed in the list of declarations. Raw materials or intermediates which produce the following products, including medicine, pesticide, veterinary medicine, cosmetic, food additives, feed, feed additives, fertilizer etc., if they belong to new chemical substances, need a notification. Chemicals that have been listed in the IECSC but are required to implement environmental management for new uses shall be registered for new uses if they are used for industrial uses other than allowable uses.
Subject of declaration:
- Domestic registrant who plans to engage in manufacturing of new chemical substances;
- Domestic registrant who plans to engage in import of new chemical substances;
- Registrants who intend to register for new uses or change finished products already managed by other laws and regulations into other industrial uses;
- Overseas manufacturers who plan to export new chemical substances to China
Note: When the applicant is a domestic applicant, he or she may directly or entrust others to apply for new chemical substances; When the applicant is an overseas applicant, he or she shall entrust a domestic registration institution to apply for new chemical substances.
Declaration of new chemical substances
According to different substance properties and tonnage, the declaration types of new chemical substances can be divided into three categories: routine registration, simple registration and filing.
Declaration type | Applicable scope |
Regular registration | If the annual production or import volume of new chemicals is more than 10 tons, routine registration is required. |
Simple registration | If the annual production or import volume of new chemical substances is more than 1 ton, but less than 10 tons, simple registration is required. |
Filing | (I) the annual production or import of new chemical substances is less than 1 ton; (II) Polymers with less than 2% of new chemical monomer or reactants; (III) Polymer of low concern; Need to go through the record. |
On Nov. 19, 2020, the National Standardization Administration issued Announcement No. 26 in 2020, officially issuing the "Chinese version of REACH Restricted Substances"-GB/T 39498-2020 Guidelines for the Use and Control of Key Chemical Substances in Consumer Goods. This standard will be implemented from Jun. 1, 2021. This standard is applicable to consumer goods, including components, spare parts, accessories, packaging and instructions for use. But, it is not applicable to food, drugs, cosmetics, tobacco, special equipment, aircraft, ships, military products and other products under special government supervision That is, in consumer goods, 117 chemicals such as heavy metals, alkanes, halogenated alkanes and alkenes, benzenes, polycyclic aromatic hydrocarbons, phenols, aldehydes, ethers, alcohols, esters and salts, amines, dyes and other chemicals that cannot be classified need to be controlled.
The release of this standard provides a basis for consumer goods regulatory authorities to carry out consumer goods quality or safety supervision, provides safety technical requirements for consumer goods related enterprises to design and manufacture products, and also provides technical reference for enterprises, governments and standard development institutions.
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