FAQs on China REACH (MEE Order No.12) Compliance – MEE-SCC

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.

1. Regarding the exemption conditions for bioaccumulation data, is LogKow < 3 sufficient for exemption?

Answer: According to the Guidelines for Environmental Management Registration of New Chemical Substances (MEE Announcement No.51, 2020), while an n-octanol/water partition coefficient (logKow) < 3 meets the exemption conditions for fish bioaccumulation testing, the logKow data must be derived from test reports.

2. For holders of Regular Notification Certificates (import type) obtained under MEE Order No.7 who first import registered substances for laboratory use only without sales, is a first activity report required?

Answer: Yes, it is required. According to the Announcement on Relevant Transitional Matters Concerning Environmental Management Registration of New Chemical Substances (MEE Announcement No.46, 2020), holders of Regular Notification Certificates obtained under MEE Order No.7 must submit a first activity report within 60 days of the first production date or the first import and transfer to processors/users, in accordance with Article 41 of MEE Order No.12.

3. Do simplified notifications obtained under MEE Order No.7 need to be changed to record notifications under MEE Order No.12?

Answer: According to Article 53 of the MEE Order No.12, registrations completed under MEE Order No.7 and Order No.17 remain valid after the implementation of MEE Order No.12. Holders of simplified notifications obtained under MEE Order No.7 must comply with the relevant provisions in MEE Announcement No.46, 2020, regarding transitional arrangements.

4. How to list the substances that obtained regular notification certificates under MEE Order No.7 into the Inventory of Existing Chemical Substances in China (IECSC)? Do enterprises need to submit applications under MEE Order No.12?

Answer: According to the Guidelines (MEE Announcement No.51, 2020), for new chemical substances with regular notification certificates under MEE Order No.7 that are not yet listed in the IECSC:

Substances with actual production or import activities but less than five years as of January 1, 2021, will be included in the IECSC by MEE announcement after five years from the first production or import date.
Substances with no actual production or import activities as of January 1, 2021, will be included in the IECSC five years after the implementation of MEE Order No.12.

Substances with regular registration certificates under MEE Order No.12 will be included in the IECSC five years after the first registration date.

Companies do not need to submit applications. Those substances will be listed in the IECSC through announcements published by MEE.

5. How to handle the change of registration certificates obtained under MEE Order No.7?

Answer: For a change of registration certificates obtained under MEE Order No.7, applications should follow the Announcement (MEE Announcement [2020] No.46).

The specific steps are as follows:

Log into the Government Affairs Service Hall website of the Ministry of Ecology and Environment of the People’s Republic of China (http://zwfw.mee.gov.cn)
Select “New Chemical Substances Category,” click “Item Declaration” under “13002 Issuance of Environmental Management Registration Certificate for New Chemical Substances Approval Matters”
Follow prompts to enter the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No.12) Matters Application Portal (New System), click “Regular Registration” or “Simplified Registration” accordingly, then select “Change of Registration Certificate” to fill and submit.

6. How to proceed with the revocation of the environmental management registration certificate for new chemical substances obtained under MEE Order No.7?

Answer: For environmental management registration certificates for new chemical substances obtained under MEE Order No.7, applications should follow the Announcement (MEE Announcement [2020] No.46) The specific steps are as follows:

Log into the Government Affairs Service Hall website of the Ministry of Ecology and Environment of the People’s Republic of China (http://zwfw.mee.gov.cn)
Select “New Chemical Substances Category,” click “Item Declaration” under “13002 Issuance of Environmental Management Registration Certificate for New Chemical Substances Approval Matters”
Follow the prompts to enter the “Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No.12) Matters Application Portal (New System),” click “Regular Registration” or “Simplified Registration” accordingly, then select “Revocation of Registration Certificate” to fill and submit.

7. How to fulfill post-registration management requirements for regular registration certificates obtained under MEE Order No.7?

Answer: Follow the relevant requirements specified in the Announcement (MEE Announcement [2020] No.46). The public disclosure and extension applications of chemical substance identification information in the Inventory of Existing Chemical Substances in China (IECSC) shall be implemented according to the relevant requirements of the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No.12).

8. After the implementation of MEE Order No.12, is it necessary to mail original paper application materials?

Answer: According to the Guidelines (MEE Announcement No.51, 2020), applicants should submit application materials through the online registration system of the State Council’s Ecological Environment Authority’s Government Affairs service platform. Original paper application materials are not required, except for cases requiring re-issuance of a new registration certificate.

9. What are the requirements for PoA in new chemical substance environmental management registration?

Answer: According to the Guidelines (MEE Announcement No.51, 2020), the following content must be clearly stipulated:

The applicant and agent shall jointly perform their obligations regarding environmental management registration and post-registration environmental management obligations related to new chemical substances, and assume responsibilities according to the regulation;
Provisions regarding responsibilities and obligations when changing agents;
The validity period of the agreements. The validity period of an agency contract or agreement shall cover that during which an applicant assumes his/her responsibilities and obligations, or be renewed before expiration thereof.

For Questions 10-19, please see: FAQs on China REACH (MEE Order No.12) Compliance – MEE-SCC – Vol.2

Source: China Solid Waste and Chemicals Management Center under the Ministry of Environment and Ecology (MEE-SCC)

Why Choose REACH24H for China REACH Compliance

At REACH24H, we specialize in providing expert regulatory services to help businesses navigate China REACH (MEE Order No.12) compliance. With our extensive knowledge and experience in chemical substance registration and management, we offer tailored solutions to ensure your products meet China’s environmental and safety standards. From new chemical substance registration to post-registration support, we are here to guide you through every step of the compliance process.

Reference: