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MEE Opens Public Consultation on New Chemical Registration Transitional Measures

MEE has opened a public consultation on the transitional measures for new chemical substances registration laid out in MEP Order No.7 and MEE Order No.12. The amendments made in MEE Order 12 will have significant impact on regulatory compliance obligations and market access requirements for stakeholders. The most significant proposal on transitional measures which will significantly disrupt relevant stakeholders relates to pending or currently under review registration applications. Under proposed changes registration applications submitted under the old regulation (MEP Order 7) that cannot be completed (registration certificate issued) before the implementation of the new regulation (MEE Order 12) will need to be re-submitted and assessed under the new requirements.

On April 29, 2020, China’s MEE released the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No.12), which will enter into effect and replace the MEP Order No.7 on January 1, 2021 (ChemLinked News). On June 3, MEE issued a notice [1] to solicit public comments on the transitional measures that will be applied. The consultation will conclude on June 20.

The transitional measures include:

1. From the date when MEE Order No.12 enters into effect, for a new chemical substance that has obtained the registration certificate for regular notification under MEP Order No.7, before it is added into the IECSC, 

1) The registration certificate holder and downstream users shall take measures to control environmental risks indicated in the registration certificate.

2) The registration certificate holder shall, according to Article 38, 39, 41, and 42 of MEE Order No.12 engage in information communication, record and keep relevant documentation materials, submit the first-time activity report, and inform the authority about the newly identified hazards of the registered substance. If it is classified as a new hazardous substance with priority environmental concern under MEP Order No.7, an annual report shall be submitted according to Article 41 of MEE Order No.12. 

3) The certificate holder can apply to the competent department of ecology and environment under the State Council for revocation of the registration certificate according to Article 33 of MEE Order No.12. 

4) The new hazardous substance with priority environmental concern under MEP Order No.7 shall still be subject to new usage environmental management and be assigned allowed uses upon being added into the IECSC.

5) The certificate holder shall re-apply for registration according to the provisions of MEE Order No. 12 and obtain a new registration certificate for the environmental management of new chemical substances if any information specified in the original registration certificate is to be changed.

2. From the date when MEE Order No.12 enters into effect, for a new chemical substance that has obtained the registration certificate for simplified notification under MEP Order No.7: 

1) The registration certificate holder shall record and keep relevant documentation materials according to Article 38 of MEE Order No.12. 

2) The registration certificate holder can apply to the competent department of ecology and environment under the State Council for revocation of the registration certificate according to Article 33 of  MEE Order No.12. 

3) The period of validity for the registration certificate for simplified notification that is subject to product and process orientated research and development (PPORD) is two years after the first-time activity.

4) The registration certificate holder shall apply for record notification, or re-apply for registration and obtain the registration certificate according to relevant provisions of MEE Order No.12 if any information specified in the original registration certificate is to be changed.

3. For the new chemical substances that obtain the registration certificate in accordance with MEP Order No.7, the competent department of ecology and environment under the State Council can revoke any registration certificate in accordance with relevant provisions in the Administrative Licensing Law of the People's Republic of China, under any of the circumstances specified in Article 35 of MEE Order No.12.

4. For new chemical substance notifications that are received before MEE Order No.12 enters into effect, which cannot obtain the registration certificates before MEE Order No.12 enters into effect because the application materials do not meet the requirements or the normal application process cannot be completed within the processing time limit, the applicant should re-apply for new chemical substance environmental management registration according to relevant provisions of MEE Order No.12 for these chemicals. 

The last transitional measure now is being heatedly discussed, for it may affect many companies who have submitted or propose to apply for registration this year under MEP Order No.7 requirements. According to this measure, if the application process cannot be completed this year, the applicant will have to re-apply under MEE Order No.12, which are significantly different from the relevant requirements in the draft revision to MEP Order No.7, which was released last July. According to the draft, registration applications that have been accepted but have not yet been approved were to be processed in accordance with the relevant provisions of Order No.7. Considering the impact proposed changes will have on compliance obligations and market access requirements for stakeholders, we suggest that applicants submit comments to authorities and avail of the opportunity to advocate for more industry-friendly transitional measures.

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