China China released three Chemical Substance related Technical Guidelines (Trial) (Draft for Comments)

Including Technical Guideline for Environmental and Health Hazard Assessment of Chemical Substances and etc.

 

On September 29, 2020, the Ministry of Ecology and Environment of the People’s Republic of China released three draft for comments of technical guidelines, and began to collect opinions. The deadline for the collection is October 26, 2020.

 

The three technical guidelines are shown as below.

  1. Technical Guideline for Environmental and Health Hazard Assessment of Chemical Substances (Trial) (Draft for Comments)
  2. Technical Guideline for Environmental and Health Exposure Assessment of Chemical Substances (Trial) (Draft for Comments)
  3. Technical Guideline for Environmental and Health Risk Indication of Chemical Substance (Trial) (Draft for Comments)

 

The Measures on Environmental Management Registration of New Chemical Substances ( No.12 by the Ministry of Ecology and Environment), which will come into force on January 1, 2021, requires that a submission of relevant assessment report is necessary when make a registration of new chemical substance. In response to the requirement, the three technical guidelines were announced to guide companies to conduct relevant risk assessments.

 

The outline of the three technical guidelines are as follows.

 

Technical Guideline for Environmental and Health Hazard Assessment of Chemical Substance (Trial) (Draft for Comments)

Provisions of procedures and contents for environmental and health hazard assessment of chemical substance. Among them, the assessment procedures are as follows:

  1. Data collection: the type of data, principles of screening, standards of preferred data, etc. are regulated;
  2. Hazards identification: methods for identifying main impact data, discrimination of PBT (Persistence, Bioaccumulation, Toxicity), and endocrine disrupting substances, etc. are regulated;
  3. Hazards indication: derivation for Predicted No Effect Concentration (PNEC) of various environmental assessment substances are regulated.

 

Technical Guideline for Environmental and Health Exposure Assessment of Chemical Substance (Trial) (Draft for Comments)

Provisions of procedures and contents for environmental and health exposure assessment of newly registered or existing chemical substance are regulated. Among them, the assessment procedures are as follows:

  1. Establish a assessment plan;
  2. Collect information;
  3. Build exposure scenarios;
  4. Estimate environmental emissions;
  5. Assess environmental exposure;
  6. Write exposure assessment reports.

 

Technical Guideline for Environmental and Health Risk Assessment (Trial) (Draft for Comments)

Provisions of discrimination principles and procedures for environmental and health risk assessment of chemical substance are regulated. Among them, the assessment procedures are as follows:

  1. Integrate the results of the hazard impact assessment (ex. PNEC) and the exposure assessment (ex. PEC [Predicted Environmental Concentration]);
  2. Determine the risk;
  3. Analyze the uncertainty;
  4. Conclude the risk assessment.

 

The original text of the above three technical guidelines can be found from the following URL (Simplified Chinese).

http://www.mee.gov.cn/xxgk2018/xxgk/xxgk06/202009/t20200930_801876.html