Interpretation of new standards for the preparation of risk assessment reports for chemical substances

Release time:

2020-03-31 11:22

On March 18, 2020, the Ministry of Ecology and Environment of the People's Republic of China issued the General Outline of Technical Guidelines for Ecological and Environmental Health Risk Assessment (HJ 1111-2020), which will be implemented from the date of issuance. After the standard was released, the majority of customers and friends expressed doubts to Xinanrun, whether the implementation of the standard will affect the management of chemical substances. To this end, Xiao An summarized the existing standard documents used to guide the risk assessment of chemical substances, which are interpreted as follows for your reference.

Summary of 1. Regulations

l General Outline of Technical Guidelines for Ecological and Environmental Health Risk Assessment (HJ 1111-2020)(issued by the Ministry of Ecology and Environment of the people's Republic of China on March 18, 2020)

l "Guidelines for the Framework of Technical Methods for Environmental Risk Assessment of Chemical Substances (Trial)" (hereinafter referred to as the "Guidelines") (issued by the Ministry of Ecology and Environment on September 3, 2019)

l "Regulations on Environmental Risk Assessment and Control of Chemical Substances (Draft for Comment)" (hereinafter referred to as "Regulations") (issued by the Ministry of Ecology and Environment on January 8, 2019)

l Guidelines for Risk Assessment of Chemical Substances (Draft for Comments) (hereinafter referred to as "Guidelines") (issued by the former Ministry of Environment on September 26, 2011)

2. Risk Assessment System Document

The regulations issued in January 2019 adopt a classified management model to manage existing and new chemical substances by establishing an environmental risk assessment and control system for chemical substances. The importance of environmental risk assessment of chemical substances is evident here. According to the provisions of Articles 12, 16 and 24 of the regulations, it can be seen that the technical methods, procedures and norms for environmental risk assessment of chemical substances formulated by the competent department of ecological environment under the State Council are the program and guiding direction of risk assessment. Priority assessment of chemical substances and new chemical substances shall be subject to corresponding risk assessment and environmental risk assessment report shall be issued. Please refer to the relevant contents of the regulations as follows:

Article 12 "The competent department of ecology and environment under the State Council shall formulate technical methods, procedures and norms for environmental risk assessment of chemical substances, and establish and improve the basic database for environmental risk assessment of chemical substances"

Article 16 "The competent department of ecological environment under the State Council shall give priority to the environmental risk assessment of chemical substances, entrust relevant technical support units to carry out hazard assessment and exposure assessment, analyze and judge the key links and degree of impact of chemical substances on the ecological environment and human health, and issue an environmental risk assessment report.

Article 24 "Enterprises that register for the environmental management of new chemical substances shall submit application forms for new chemical substances, test reports or materials on the physical and chemical properties, health toxicology and ecotoxicology of new chemical substances, reports on environmental risk assessment and risk control measures of new chemical substances, and photocopies of legal person certificates and business licenses."

Accordingly, the general outline is a standard document issued by the Ministry of Ecology and Environment applicable to "guiding the environmental health risk assessment carried out in the process of ecological environment management for the prevention and control of environmental chemical factors closely related to public health.

The Guide "applies to the environmental risk assessment of different exposure routes during the normal production and use of a single chemical substance, and does not apply to the risk assessment under the condition of accidental leakage." It is a risk assessment of chemical substances under normal production and use. In order to strengthen the environmental management of chemical substances, establish and improve the technical and methodological system of environmental risk assessment of chemical substances, standardize and guide the environmental risk assessment of chemical substances.

The "Guidelines" "Expert review and declaration of new chemical substances to complete the risk assessment report, as well as the risk assessment of existing chemical substances.", clear the technical methods and procedures of risk assessment, but the overall content is relatively simple, the scope of application of the model is narrow, has been far from the current risk assessment requirements.

The general outline throughout the description focuses on the assessment of risks to human health from chemical factors in the environment, while the guidelines and guidelines focus on a broader scope, covering both ecological environment and human health. The above can be seen from the terminology/basic points of exposure assessment, exposure scenario and risk characterization in the three documents, as shown in the following table:

3. directional analysis

Compared with the current guidelines on the main basis of chemical substance risk assessment, the biggest change in the guidelines and general guidelines issued after 2019 is the health risk assessment. One of the guidelines and general guidelines on health exposure focuses on "human health exposure assessment through environmental indirect exposure" and "exposure to target environmental factors", paying more attention to the possible harm and risk assessment of chemical substances acting on human body through environmental exposure.

Through the past two years, the Ministry of Ecology and Environment has frequently updated/issued various standards/regulations related to environmental risk assessment, and it is foreseeable that the requirements for chemical substance risk assessment will be more detailed and scientific in the future. In the daily production/use of chemical substances, enterprises need to focus on the possible environmental/health effects, carry out necessary monitoring and keep records to deal with them.

Xinanrun (Beijing) Consulting Co., Ltd. was established in 2009, focusing on chemical regulations and compliance consulting services. With its profound professional technical strength and multi-resource advantages, it is committed to serving pharmaceutical, chemical companies, consumer goods manufacturers, and large multinational companies. The company provides chemical regulations consulting and environmental protection regulations response services. At present, our chemical regulatory consulting services include domestic new chemical substance declaration, hazardous chemicals registration, SDS/GHS label production, South Korea K-REACH registration, medicine, cosmetics regulatory consulting, environmental protection regulatory consulting services, including park environmental protection housekeeper, solid waste and hazardous waste comprehensive solution design, etc.

If you have chemical registration, environmental compliance issues, please contact us!

Contact: Miss Ann

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Electronic E-mail: nar@china-reach.net

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