by Lily Hou, PhD, CHMM
On January 8, 2019, the Ministry of Ecology and Environment (MEE) published the draft Regulations on Chemical Substances Environmental Risk Assessment and Control for public comments. The new regulations intend to establish a national system to cope with chemical risks and accomplish the Agenda 21 goal that “all countries achieve the environmentally sound management of chemicals and wastes throughout their life cycle, and propose legislation to strengthen the national capacity for management of chemicals by the year 2020”.
The regulations, covering both new and existing chemical substances, contain the following three key aspects:
Existing chemical environmental risk assessment
The MEE will carry out screening of existing chemicals to identify candidates for priority listings and will conduct risk assessments for the priority chemicals that are believed to be risks to human health and the environment. Chemical manufacturers, importers and users are required to submit an annual report including uses and quantity information for all existing chemicals. For priority existing chemicals, more information, such as environmental release data, physical-chemical, toxicological and ecotoxicological data, shall be provided as well.
Existing chemical environmental risk control
The MEE, coordinating with several other ministries, will focus their resources on risk management of three catalogues of chemicals, including:
- Catalogue of Priority Controlled Chemicals which contains chemicals that are hazardous and persistent and which pose greater risks to the public health. Risk control measures, such as a discharge permit or a mandatory clean manufacturing audit, are adopted to reduce the impact of production and use of these chemicals on human health and the environment;
- Catalogue of Severely Restricted Chemical Substance which contains chemicals that can’t be safely used even when appropriate risk control measures are taken. These chemicals are subject to import/export license management;
- Catalogue of Prohibited Chemical Substance which contains chemicals that are completely banned from import, manufacture and use.
New chemical registration and risk controls
The new Regulations also include provisions on new chemical substances which are currently regulated under the MEP Order 7, the Measures for Environmental Administration of New Chemical Substances. Important changes introduced by the Regulations include:
- The new chemical registration requirement only applies to chemical substances not listed on the Inventory of Existing Chemical Substance in China (IECSC) with an annual production or import quantity greater than 1 tonne;
- The following three categories of chemicals shall be filed to the MEE for record-keeping:
- new chemical substances manufactured or imported in amounts less than 1 tonne a year; or
- new polymers containing less than or equal to 2% new monomers or which are “low concern polymers”; or
- new chemical substances manufactured or imported for technical research and product development in a quantity less than 10 tonnes a year;
- Chemical substances used for laboratory research are exempt from the Regulations. This exemption applies to new chemical substances with an annual production or import quantity less than 100 kg and existing chemical substances.
MEP Order 7 is currently under revision and the new rules are expected to be incorporated into the next version.
The public comment period for the new Regulations ends on February 20, 2019.
Readers should access the MEE website to stay informed of the development status of the legislation.
Notice of Public Consultation on the Draft Chemical Substances Risk Assessment and Control Regulations (Chinese only):
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Ministry of Ecology and Environment (MEE)
Chemical Substances Environmental Risk Assessment and Control Regulations