China China releases Technical Guidelines on Health Hazard Assessment, etc. of Chemical Substances

China’s Ministry of Ecology and Environment released the following 3 technical guidelines on December 23, 2020.

  • Technical Guidelines for Environmental and Health Hazard Assessment of Chemical Substances (Trial)
  • Technical Guidelines for Environmental and Health Exposure Assessment of Chemical Substances (Trial)
  • Technical Guidelines for Environmental and Health Risk Characterization of Chemical Substances (Trial)

The “Measures for the Environmental Management and Registration of New Chemical Substances” (Decree No. 12 of Ministry of Ecology and Environment), which takes effect on January 1, 2021, requires the submission of relevant risk assessment reports when registering various new chemical substances. The following is an example of the relevant provisions of the Measures. (A part of the content is omitted)

Article 15 When applying for regular registration, a report should be submitted that includes an assessment of the environmental risks that may arise from the new chemical substance which the registration is planned.
Article 16 When applying for simplified registration, the applicant shall also submit other information of the new chemical substances on the environmental and health hazards and environmental risks that the submitter already knows.

The following is a summary of the “Technical Guidelines for Environmental and Health Hazard Assessment of Chemical Substances (Trial)”.

Application Scope
Applicable to the assessment of environmental and health hazards of chemical substances, and stipulates work procedures, assessment contents, basic methods, and technical requirements for the assessment.

Assessment Procedure
Data collection, identification of hazards to the environment and human health, and determination of hazards to the environment and human health.

Determination of hazards
The following is an example of a method for determining aquatic environmental hazards.

PNEC* of aquatic environmental organisms = major effect value for ecotoxicology (e.g. LC50)/evaluation factor

      • PNEC: Predicted No-Effect Concentration

For the original text of the above guidelines, please refer to the following URL (Simplified Chinese).
https://www.mee.gov.cn/xxgk2018/xxgk/xxgk01/202012/t20201225_814802.html