China released registration rules of new chemical substances

On October 26, 2020, the Ministry of Ecology and Environment of the People’s Republic of China released an announcement on matters related to the transition of registration of environmental management of new chemical substances. In the background, the “Registration Measures for Environmental Management of New Chemical Substances” (Decree No.12 of Ministry of Ecology and Environment) was promulgated on April 29, 2020, and will come into force on January 1, 2021, at the same time, the “Measures for Environmental Management of New Chemical Substances” (Decree No.7 of Ministry Environment Protection) will be abolished. The announcement was released for the related work of environmental management registration can be orderly carried out, and the main contents of the announcement are as follows

Transition regulations for regular declarations

After the new Measure came into force on January 1, 2021, the new chemical substances that had obtained the new chemical substances regular declaration and registration certificate which comply with the old Measure, should follow the regulations below:

1. Implementation of the environmental risk control measures
   • The holder of the registration certificate and the corresponding user should adopt environmental risk control measures following the provisions of the registration certificate.
2. Reporting the information transmission and keeping records
   • The registration certificate holders should transfer information, record and store documents, report the initial activity and report new hazard information in accordance with the Article 38, 39, 41, and 42 of the new Measures.
   • Among them, the new chemical substances that belong to the key hazardous substances for environmental management specified in Article 3 of the old Measure, should also submit an annual report in accordance with the Article 41 of the new Measure.
3. Application for revocation of registration certificate
   • According to the Article 33 of the new Measure, the registration certificate holders can apply to the Ministry of Ecology and Environment for revoking the registration certificate.
4. Regulations on registration for new applications
   • The key hazardous substances for environmental management, which was specified in the article 3 of the old Measure, should continue to conduct the regulations of registration for new applications, and stipulate the permitted usages when listed in the “Existing Chemical Substance List of China”.
5. Regulations on the modification of registration certificate
   • If a registration certificate holder is planning to make modifications on registration certificate, he should submit an application again for a environmental management registration certificate of new chemical substances according to the provisions of the new Measure.
   • For any situation following, the certificate holders can apply for making modification of the registration certificate by referring to the article 30 of the new Measures.

The registered quantity is to be decreased;

The type of activity changes from production to import or increase import;

The identification information of the new chemical substance registered Chinese/English name or CAS registration number to be changed;

The name of the applicant or agent is going to be changed.

Regulations for simplified declarations transition

From the new Measures comes into force on January 1, 2021, the substances that had obtained the certificate of simplified declaration under the old Measures should follow the regulations below.

1. Reporting information and keeping records

• According to Article 39 and Article 42 of the new Measures, the certificate holders should record and store documents, and report new hazard information.

2. Application for revocation of registration certificate

• According to Article 33 of the new Measures, the certificate holders can apply to the Ministry of Ecology and Environment for revoking the registration certificate.

3. The validity period of R&D registration certificate for technologies and products

• The validity period for simplified declaration registration certificate of technologies and products is two years after first activity.

4. Regulation on the modification of registration certificate

• If the registration certificate holder is planning to make modifications on registration certificate, he should make a record of environmental management of new chemical substances, or submit a application again for the environmental management registration certificate of new chemical substances according to the provisions of the new Measures.
• For any situations following, the certificate holders can apply for making modification on the registration certificate by referring to the provisions of article 30 of the new Measure.

The registered quantity is less than 1 ton after modification;

The registration certificate is obtained for R&D of technologies and products, the registered quantity is less than 10 tons after modification, and the registration certificate is still valid;

The monomer content of a new chemical substance is no more than 2%, or belonging to polymers of low concern.

If it compliance with the Article 35 of the new Measures, the registration certificate obtained under the old Measures will be revoked.

The applicant or agent obtained the registration certificate by fraud, bribery, or other illegal means.

Transition of approval before and after the new Measures coming into force

• Applications for registration certificate received before the new Measure coming into force can be dealt with under old Measures before June 30, 2021.
• If the registration cannot be obtained by June 30, 2021, it will be dealt with under the new Measures requirements.

The original text of the announcement can be found from the following URL (Simplified Chinese).
http://www.mee.gov.cn/xxgk2018/xxgk/xxgk01/202010/t20201029_805427.html