New changes in China's new chemical substance compliance

On January 1, 2021, the Ministry of Ecology and Environment of China implemented the " Measures for the Environmental Management Registration of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment of the P. R. China)" (referred to as "Order No. 12"). This regulation replaced the "Measures on the Environmental Management of New Chemical Substance" (Order No. 7 of the Ministry of Environmental Protection) issued by the original Ministry of Environmental Protection, and became a brand-new management standard for new chemical substances in China.

Order No. 12 stipulates that new chemical substances not included in the "Inventory of Existing Chemical Substances in China"(IECSC), before companies produce or import new chemical substances into China, they must register new chemical substances in accordance with regulations. Only after the Ministry of Ecology and Environment has granted the environmental management registration certificate for new chemical substances can the production and import activities of new chemical substances be carried out.

Order No. 12 stipulates 3 types of registration, including:

Record Registration: 1）Annual Manufacturing / Importation Volume <1 t/a;

2）Polymers containing less than 2% monomers or reactants which are new chemical substances, or polymers of low concern (no volume limit)

Simplified Registration: 1 t/a ≤ Annual Manufacturing / Importation Volume < 10 t/a

Regular Registration: Annual Manufacturing / Importation Volume ≥ 10 t/a;

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