The Measures for the Registration of the Environmental Management of New Chemical Substances, that is, the Ministry Order No. 12, is a brand new management standard for new chemical substances in China.
Before the production of new chemical substances in China or the import of new chemical substances into China, for chemical substances not included in the "List of Existing Chemical substances in China" (that is, IECSC), it is necessary to register new chemical substances in accordance with the regulations, after obtaining the environmental management registration certificate of new chemical substances, the production or import of new chemical substances can be carried out.
China's new chemical substance registration is divided into new chemical substance filing registration, new chemical substance simple registration, new chemical substance routine registration and new use environmental management registration.
1, new chemical substances routine registration application:
Annual production or import of new chemical substances of 10 tons or more.
2, new chemical substances routine registration subject:
Domestic production enterprises/import enterprises and overseas enterprises exporting to China (must entrust domestic agents).
3, new chemical substances routine registration material requirements:
Application form, legal person certificate or business license agent contract or agreement (overseas applicant), authorization letter (if required), test report or information, environmental risk assessment report, social and economic benefit analysis report (high hazard substances), Necessary information protection materials (if required), commitment to implement or transmit environmental risk control measures and environmental management requirements, qualification certificate of testing organization, other information already in the possession of the applicant about the environmental and health hazard characteristics and environmental risks of the applied material
4, the routine registration cycle of new chemical substances: 14~24 months
5. Obligations after routine registration of new chemical substances:
Information transfer, data preservation, information disclosure, first activity report, annual report, new hazard information and environmental risk tracking, subject to environmental supervision spot checks.





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