China Regulatory News

On the 24 December 2020, China’s Ministry of Ecology and Environment (MEE) released the final versions of technical risk assessment guidelines. These guidelines will guide and regulate risk ...

On the 24 December 2020, China’s Ministry of Ecology and Environment (MEE) released the final versions of technical risk assessment guidelines. These guidelines will guide and regulate risk assessment activities and assisting the implementation of MEE Order No.12.

The recently published guidelines are:

• Environmental and Health Hazard Assessment (trail) – Appendix 1

This guideline uses GB 30000 series standards and GB/T 24782 as the main resources in hazardous assessment. It sets down the general principles and requirements for the assessment procedures and contents of chemical substances.

• Environmental and Health Exposure Assessment (trail) – Appendix 2

The main material referred in this guideline is HJ 2035 standard – Technical Guideline on Solid Waste Disposal. This guideline is supposed to be used for risk assessment of environmental and health exposure evaluation.  

• Environmental and Health Risk Characterization (trail)- Appendix 3

There is no specific standard referred to in this guideline. However, this guideline will rely on MEE Order No.12, Guidelines for MEE Order No.12, and the Technical Framework Guidelines on the Risk Assessment of Chemical Substance which are the common resources for the three guidelines. Specifically, it includes the main principles, procedures, and technical points for environmental and health risk characterization of chemical substances.

All of the three guidelines mentioned above came into force from the day they were enacted. However, as the term ‘trail’ in the name of the guidance indicated, these guidelines can be modified depending on the actual situation of implementation.  

Download Environmental and Health Hazard Assessment (trail) – Appendix 1 (In Mandarin)

Download Environmental and Health Exposure Assessment (trail) – Appendix 2 (In Mandarin)

Download Environmental and Health Risk Characterization (trail)- Appendix 3 (In Mandarin)

Update: 2021-01-20

  On 21 Dec. 2020, China MEE announced that the second batch of 238 substances have fulfilled the requirements for IECSC supplementation and will be managed as existing chemical subst...

On 21 Dec. 2020, China MEE announced that the second batch of 238 substances have fulfilled the requirements for IECSC supplementation and will be managed as existing chemical substances. 

On 17 November 2020, China MEE released a public consultation on 245 substances that have applied for IECSC supplementation. Among them, 238 substances have passed the review and have been added to the IECSC. The rest 7 substances are still new chemical substances and will be managed as new substances. 

MEE also reminds enterprises that substances not listed in IECSC will be regarded as new substances and have to be registered as per the new regulation MEE ORDER 12 effective from January 2021. 

Update: 2021-01-19

To ensure the implementation of Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No.12), MEE released the final version of Guidance on the application o...

To ensure the implementation of Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No.12), MEE released the final version of Guidance on the application of MEE Order No.12 which is expected to come into force the same day as MEE Order No.12 on 1 January 2020. In the meantime, the previous guidance and its supporting measures issued in 2010 and data requirements issued in 2017 under MEP Order No.7 will be invalided.

This Guidance should be used together with MEE Order No.12 by applicants, agents and processing users. It contains guidance on registration scope, types, procedures, document and data requirement, special rules on polymer, new use management, certificates management, post-registration management and etc. Along with the guidance, relevant registration forms including registration application form, registration management form, information report form, and use code table are also released. Comparing to the previous scattered situation, MEE codified most of the requirements and instruction together into the Guidance and registration form instruction.

With the approaching of the implementation of MEE Order No.12, MEE published a transition measure – Notice on Transitional Arrangements for Environmental Management Registration of New Chemi...

With the approaching of the implementation of MEE Order No.12, MEE published a transition measure – Notice on Transitional Arrangements for Environmental Management Registration of New Chemical Substance – on 27th October 2020. This measure aims to ensure the orderly continuity of new chemical substance registration activities during the transition period from MEP Order No.7 to MEE Oder No.12.

According to the transition measure, registration applications submitted under Order No.7 could still be processed under Order No.7 after the 1st January 2021when Order No.12 takes effect. But if a final decision hasn’t been made until 30th June 2021, the registration application has to follow the requirements under Order No.12. For those who obtain the certificates under Order No.7, they still have to fulfill the following obligations after the new regulation come into force next year.

For regular registration certificates holders:

• Adopting environmental risk control measures according to the certificate requirements.
• Information communication under Order No.12.
• New use management applies to hazardous chemical substances characterized under article 3 of Order No.7.

For simplified registration certificate holders:

• Information communication under Oder No.12.
• Certificates obtained by research purpose is valid for 2 years since the first activity.

In case registrants wish to change any information on the registration certificate, they need to reapply under MEE Order 12. But changing of information mentioned below could be processed just by applying for changing of information under Article 30 of MEE Order No. 12.

China opened a public consultation on the new Guidance on Environmental Management Registration of New Chemical Substances. The draft guideline provides implementation design for the MEE ORDER 12 with...

China opened a public consultation on the new Guidance on Environmental Management Registration of New Chemical Substances. The draft guideline provides implementation design for the MEE ORDER 12 with regards to the scope of registration, data requirements of registration types, special rules on polymer registration, CBI, CSR, Socio- economic survey report, Post notification obligations and Penalities. 

All the stakeholders i.e organizations, enterprises and institutions and individuals may submit written comments and suggestions in accordance with the form of feedback recommendations by Sept 6 2020.

For further details, please refer this link:

http://www.mee.gov.cn/xxgk2018/xxgk/xxgk06/202008/t20200817_793827.html?from=timeline

On April 29, 2020, China's Ministry of Ecology and Environment (MEE) published the Measures on Environmental Management Registration of New Chemical Substances (MEE Order 12). The amendm...

On April 29, 2020, China's Ministry of Ecology and Environment (MEE) published the Measures on Environmental Management Registration of New Chemical Substances (MEE Order 12). The amendment will come into force on January 1, 2021 and replace the current MEP Order 7. The updated text focuses on the management of persistent (P), bioaccumulative (B), and toxic (T) substances, including defining scenarios in which substances meeting the PBT criteria will not be approved. MEE Order 12 introduces Simplified Registration as well as post-registration management. 

Depending on annual tonnage, new chemical substances will be subject to three types of registrations: Regular Registration, Simplified Registration, and Filing. 

New substances with annual volumes between 1 and 10 tons will be subject to the Simplified Registrations under MEE Order 12. Registrants should provide following information: (1) the application form; (2) physicochemical properties, and ecotoxicological study reports or materials regarding persistency, bioaccumulation, and aquatic environmental toxicity; and (3) a commitment letter on implementation or transmission of environmental risk control measures.

For New Substances of more than 10 tons, registrants should submit Regular Registration, including following information: (1) the application form; (2) physicochemical, toxicological and ecotoxicological test reports or materials; (3) an environmental risk assessment report; and (4) a commitment letter on implementation or transmission of environmental risk control measures.

The first-activity report is required for both Simplified Registrations and Regular Registrations and should be submitted within 60 days since the first manufacture or the first transfer to customers after import.

CBI Protection: CBI protection for substances currently in the IECSC will be abolished by 31 December 2025. The maximum time applicable for CBI protection of new substances added to the inventory of existing chemicals in China (IECSC) will be 5 years.

For further details, please click on the link to the official announcement 

www.mee.gov.cn/xxgk2018/xxgk/xxgk06/202006/t20200603_782493.html

For further information, kindly contact us on compliance@gpcregulatory.com

MEP Order NO.7 has been China’s main chemical regulation since 2010 and it only controls new chemicals. The regulation has been revised by the Ministry of Ecology and Environment (MEE) and the revision of MEP Order No.7, Measures on the Environmental Management of New Chemical Substances (MEE Order No. 12), published on 29 April 2020, is expected to be effective from 1 January 2021. Obligations and challenges under China’s new and revised chemical laws have been a major concern for companies.

See our Regulatory Manager Chia-Sui Hsu's insights on the revision in Chemical Watch’s annual Global Service Providers Guide (2020) (p.58-59). 

SPG Article