The "Registration Measures for Environmental Management of New Chemical Substances" (Order No. 12 of the Ministry of Ecology and Environment) (hereinafter referred to as the "Measures") stipulates that:
Prior to the production and import of new chemical substances, registration must be carried out, and applicants are required to provide ecological toxicity testing reports conducted using Chinese test organisms within China during the registration process.
Not applicable refers to Article 2 of the Measures, which stipulates that the following products or substances are not applicable to this Measures:
(1) Pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers and other products, except for new chemical substances that are changed to other industrial uses and used as raw materials and intermediates for the aforementioned products;
(2) Radioactive substances.
Those who meet one of the following conditions shall apply for the environmental management record of new chemical substances:
(1) The annual production or import volume of new chemical substances is less than 1 ton;
(2) Polymers with a new chemical monomer or reactant content not exceeding 2% or belonging to low concern polymers.
If the annual production or import volume of new chemical substances exceeds 1 ton and is less than 10 tons, a simplified registration for environmental management of new chemical substances shall be obtained.
To apply for simplified registration, the applicant shall submit the following materials:
(1) Simplified registration application form;
(2) Physical and chemical properties of new chemical substances, as well as ecotoxicological testing reports or materials on their persistence, bioaccumulation, and aquatic environmental toxicity;
(3) The commitment letter for implementing or transmitting environmental risk control measures shall be signed by the legal representative or authorized person of the enterprise or institution, and stamped with the official seal.
For new chemical substances with an annual production or import volume of more than 10 tons, regular registration for environmental management of new chemical substances should be completed.
To apply for regular registration, the applicant shall submit the following materials:
(1) Regular registration application form;
(2) Test reports or materials on the physical and chemical properties, health toxicology, and ecotoxicology characteristics of new chemical substances;
(3) A report on the environmental risk assessment of new chemical substances, including an assessment of the potential environmental risks caused by the new chemical substances to be applied for registration, an analysis of the proposed environmental risk control measures and their suitability, and an assessment conclusion on whether there are unreasonable environmental risks;
(4) The commitment letter for implementing or transmitting environmental risk control measures and environmental management requirements shall be signed by the legal representative or authorized person of the enterprise or institution, and stamped with the official seal.