FAQs on China REACH (MEE Order No.12) Compliance – MEE-SCC – Vol.2
Introduction
China REACH (MEE Order No.12), effective from January 1, 2021, establishes regulatory requirements for companies manufacturing or importing new chemicals not listed in the Inventory of Existing Chemical Substances in China (IECSC). Under this regulation, enterprises must submit registration dossiers to the Solid Waste and Chemicals Management Center of MEE (MEE-SCC) for approval before bringing any new chemical substances to the Chinese market. Failure to comply may result in penalties.
China REACH includes several registration pathways—regular, simplified, new usage registration, and record notification—to control environmental and health risks for new chemicals.
Navigating the complex regulatory requirements of China REACH (MEE Order No.12) can be challenging. This FAQ aims to provide clear answers to common questions about new chemical substance environmental management registration.
For Questions 1-9, please see: FAQs on China REACH (MEE Order No.12) Compliance – MEE-SCC – Vol.1
10. Is there a minimum quantity requirement for new usage environmental management registration applications?
Answer: There is no minimum quantity requirement for new usage environmental management registration applications. New usage registration is required for industrial uses other than the permitted industrial uses.
11. When can activities begin after submitting a new chemical substance environmental management record notification?
Answer: According to the Guidelines (MEE Announcement No.51, 2020), after the applicant submits complete record notification materials, the online registration management system automatically sends a record notification receipt. The applicant can then conduct activities related to the new chemical substance according to the notified content.
MEE shall organize its subordinate environmental management agency for chemical substances to carry out random checks on the conformity of the record materials.
- If the random check reveals that the submitted materials do not meet requirements or are insufficient to determine compliance with record notification conditions, the applicant shall make one-time corrections according to the correction notice.
- If the random check reveals that the notified substance does not meet record notification conditions and should obtain regular or simplified environmental management registration certificates, MEE will cancel the notification. The applicant shall bear the corresponding legal responsibilities stipulated in the “Measures for Environmental Management Registration of New Chemical Substances” and apply for regular or simplified environmental management registration certificates accordingly.
12. How can record notification information be modified when notification matters or related information changes?
Answer: When record notification matters or related information changes, the applicant shall promptly update the notification information through the online registration management system and obtain a record modification receipt.
13. What is the deadline for submitting the annual report for new chemical substances?
Answer: According to the Guidelines (MEE Announcement [2020] No.51), environmental management registration certificate holders or their designated agents shall submit the annual report on new chemical substances by April 30th each year, starting from the year following registration, as stipulated in Article 41, Paragraph 2 of the Measures for Environmental Management Registration of New Chemical Substances (MEE Order No.12).
14. How should the Annual Report Form of New Chemical Substances be submitted when there are changes to the environmental management registration certificate?
Answer: When there are changes to the new chemical substance environmental management registration certificate, submit one Annual Report Form of New Chemical Substances based on the modified registration number, including the full year’s activities both before and after the modification.
15. If a new certificate is obtained after the change of the new chemical substance environmental management registration certificate, is it necessary to submit the first activity report of the new registration certificate?
Answer: If the first activity report was already submitted for the original environmental management registration certificate, there is no need to submit a first activity report for the new certificate. Otherwise, it is required.
16. Where the applicant has obtained a simplified registration certificate for a new chemical substance and has applied for regular registration and obtained the regular registration certificate, can this applicant simultaneously hold both certificates for the same new chemical substance?
Answer: No. According to the Guidelines (MEE Announcement [2020] No.51) , new chemical substances meeting low application conditions may choose to apply for registration under higher application conditions, and a new certificate will be issued to replace the old one.
17. If the annual production or import volume of a polymer is less than 1 ton, can it choose the record notification circumstance of “new chemical substances with an annual production or import volume less than 1 ton”?
Answer: Yes.
18. What are the application form requirements when changing the applicant’s name or agent’s name on the new chemical substance environmental management registration certificate?
Answer: When changing the registration certificate applicant’s name or agent’s name, fill in the proposed new name in the “2. Applicant Name” or “3. Agent Name” sections. Please refer to the Guidelines (MEE Announcement [2020] No.51) for specific examples.
19. Is it necessary to provide a SMILES code when registering new chemical substances?
Answer: For application substances with unique and definite molecular structures, their SMILES codes must be provided.
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