On December 30, 2009, the Ministry of Environmental Protection of China revised and adopted the "Measures for the Environmental Management of New Chemical Substances" at its third ministerial meeting. The revised measures were promulgated on January 19, 2010, and officially came into effect on October 15, 2010.
The term "new chemical substances" in these regulations refers to chemical substances not listed in the "Inventory of Existing Chemical Substances in China." The "Inventory of Existing Chemical Substances in China" is formulated, adjusted, and published by the Ministry of Environmental Protection.
The "Measures for the Environmental Management of New Chemical Substances" issued by the State Environmental Protection Administration on September 12, 2003, were simultaneously repealed.
The key points of the "Measures for the Environmental Management of New Chemical Substances" include the following five points:
1. Scope of application (Article 2):
(a) Environmental management of activities involving the research, production, import, processing, and use of new chemical substances within the customs territory of the People's Republic of China. Environmental management of activities related to new chemical substances within bonded zones and export processing zones. The management of pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, feed additives, etc., shall be governed by relevant laws and regulations; however, this management method shall also apply to the environmental management of activities related to new chemical substances that serve as raw materials and intermediates for the aforementioned products.
(b) Finished products designed to release new chemical substances during normal use shall be managed in accordance with this management method.
2. Classification Principles (Article 3): Based on the identification and classification standards for the hazardous characteristics of chemicals, new chemical substances are divided into general new chemical substances and hazardous new chemical substances. Hazardous new chemical substances that possess persistent, bioaccumulative, or environmentally and health-hazardous characteristics are classified as key environmental management hazardous new chemical substances.
3. Information Dissemination and Risk Management Measures (Articles 30-32): This regulation requires registration certificate holders who apply for new chemical substances to clearly define the hazardous characteristics of the new chemical substance in their Safety Data Sheet (SDS) and to convey the following information to downstream processors or users:
(a) Risk control measures specified in the registration certificate;
(ii) Safety Data Sheet for Chemicals;
(iii) Classification results according to chemical classification, warning labels, and safety instructions;
(iv) Other relevant information.
In addition, holders of registration certificates who file regular declarations should take one or more risk control measures to reduce the release of new chemical substances and environmental exposure.
4. List of Existing Chemical Substances in China and Hazardous New Chemical Substances (Article 41): Chemical substances that were legally produced or imported into the People's Republic of China before October 15, 2003, are listed in the "List of Existing Chemical Substances in China" by the Ministry of Environmental Protection. New chemical substances in the general category will be included in the "List of Existing Chemical Substances in China" by announcement from the Ministry of Environmental Protection five years after the date of the first production or import activity by the registration certificate holder. Holders of registration certificates for hazardous new chemical substances should submit a report on their actual activities to the registration center six months before the date of the first production or import activity, which is five years prior to the registration date.
5. Penalties (Articles 43-46): If a company violates the regulations by starting to manufacture/use a new chemical substance without obtaining a new chemical substance registration certificate, failing to take risk management measures, failing to provide downstream users/processors with relevant risk and hazard information, or providing a forged substance registration certificate, the local environmental protection bureau or the Ministry of Environmental Protection will impose a fine of between RMB 10,000 and RMB 30,000.
6. Adopt the Globally Harmonized System on Classification and Labelling of Chemicals (Articles 10 and 30): The new Environmental Management Regulations for Chemical Substances clearly require the adoption of GHS standards for chemical classification and labelling.
6. Adopt the Globally Harmonized System on Classification and Labelling of Chemicals (Articles 10 and 30): The new Environmental Management Regulations for Chemical Substances clearly require the adoption of GHS standards for chemical classification and labelling.
