The Guidance Documents for New Chemical Substance Notification in China is Released for Public Consultation

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On 29 Apr. 2020, China MEE has released the Revised Provisions on Environmental Administration of New Chemical Substances (MEE Order No. 12), which will take effect from 1 Jan. 2021. As a significant guideline for MEE Order No. 23, the Guidance Documents for New Chemical Substance Notification (hereinafter referred to as Guidance Documents) is also under revision. The Guidance Documents will provide guidance for enterprises to complete the registration of new chemical substances.

The Guidance Documents for New Chemical Substance Notification in China (draft for public comments) has been released on 17 Aug. 2020. Major contents of the Guidance Documents cover:

  • Registration Scope
  • Registration Type
  • Registration Procedure
  • Requirements for Registration Materials
  • Special Provisions for Polymers
  • New Usage Application
  • Re-registration
  • Change, Withdrawal and Revocation of Registration
  • Post-registration tracking

As a supportive document of the MEE Order No. 12, the Guidance Documents have detailedly explained the registration scope, registration type, data requirements, hazard assessment, environmental risks assessments, etc, which are significant for new chemical substances notification in China.

The draft Guidance Document contains changes to:

  • The registration scope;
  • Technical review for regular registration and simplified registration;
  • The data requirements;
  • Judgment of highly hazardous substances
  • Risk assessment report and social-economic benefit analysis report;
  • Information protection;

The Registration Scope

Under MEE Order No. 12, new substances registrations will be divided into simplified registration, regular registration and record.

Registration type

Regular Registration

Simplified Registration

Record

Registration condition

More than 10t/a

1-10t/a

1. Less than 1t/a;

2. Monomers of new substances, polymers containing less than 2%w/w new substances and polymers of low concern;

Technical review for regular registration and simplified registration

Registration materials of regular registration and simplified registration need to be reviewed. Technical review will not be approved in the following circumstances:

Registration type

Circumstance

Regular registration and simplified registration

Provides fraudulent information or intentionally conceals some information when applying for registration

Regular registration and simplified registration

Submits the incorrect substance name or identifier

Regular registration and simplified registration

Test reports do not meet requirements or are of low quality

Regular registration

Contents of the environmental risks assessment report have major defects or omissions and are not sufficient for the competent authority to fully evaluate the risks of the new substances

Regular registration

Unreasonable environmental risks are found through environmental risks assessment or the environmental risks control measures are inappropriate;

Regular registration

Not necessary to apply for activities of highly hazardous substances;

Regular registration and simplified registration

Fails to provide related testing reports or data within six months after technical review

Simplified registration

Substances are persistent, bio-accumulative and toxic

Simplified registration

Substance with accumulative environmental risks;

The data requirements

The data required for registration cover minimum data and other data. The minimum data shall come from the testing report. In special cases where practical testing cannot be carried out, non-test data can also be used. Registrants must explain the reason for use, the method and source of data when submitting non-test data.

Registrants of regular registration and simplified registration shall at least submit minimum data. The minimum data cover basic data and special data.

The special data is required for:

  • Simplified registration – when a substance is persistent and bio-accumulative;
  • Regular registration – when a substance is persistent or bio-accumulative.

Detailed information of the data requirements can be seen in the Data Requirements under Guidance Documents for New Chemical Substances Notification.

Judgment of highly hazardous substances

Highly hazardous substances refer to PBT substances, vPvB substances or substances with equivalent environmental or health risks.

The Guidance Documents provide the judgment criterion for highly substances. Applicants are able to judge whether the substances are highly hazardous based on the basic data. Unless further data is provided, or substances that are potentially persistent, bio-accumulative and toxic will be deemed as PBT substances.

Requirements for risk assessment report and social-economic benefit analysis report

The draft Guidance Documents have provided the requirements for preparation of environmental risks assessment reports. Compared with the current Guidance, the draft Guidance Documents have higher requirements. Companies are required to submit quantitative reports of risk assessment, exposure assessment and environmental risks assessment.

Besides, under the draft Guidance Documents, registrants of regular registrations or new uses registrations for highly substances are required to submit an additional socio-economic benefit analysis report.

Information protection

Under the draft Guidance Documents, enterprises are able to apply for CBI protection for the registration applications, the record materials and other confidential business information when submitting the applications for registrations/record. To apply for CBI protection, enterprises shall submit additional information to demonstrate the necessity of information protection.

The draft Guidance Documents also provide exemption conditions where CBI protection application materials are not required: if enterprises need to apply for information protection for information such as manufacturing technique, sales information, clients' information, composition and proportion of new substances in a mixture, usage (except those under new usage management) and manufacturing/import tonnage, they do not need to submit the proving documents.

The Guidance Documents are now available for public consultations. Comments can be sent before 6 Sep. 2020.

If you have any needs or questions, please contact us at service@cirs-reach.com.

CIRS is to host a free webinar to give an interpretation to the draft Guidance Documents for New Chemical Substance Notification and provide the countermeasure proposals on 17 Sep. 2020. The webinar will be given in English, Chinese and Japanese. If you would like to know more info about the free webinar, please click here.

Reference

MEE Official Notice

Guidance Documents for New Chemical Substances Notification in China - Interpretation to the Data Requirements