Introduction to New Chemical Substance Declarations:

The Measures for Environmental Management of New Chemical Substances was revised and adopted by the Ministry of Environmental Protection (MEP) on December 30, 2009, and came into effect on October 15, 2010. According to the “Measures for Environmental Management of New Chemical Substances”, enterprises must make a declaration of new chemical substances before producing or importing new chemical substances in China and receive the registration certificate for environmental management of new chemical substances before they can legally produce or import new chemical substances. Hotline: 135 2473 3472

Scope of New Chemical Substance Notification:

The scope of declaration of new chemical substances is mainly new chemical substances that are not listed in the List of Existing Chemical Substances in China (hereinafter referred to as “the List”), including:

1) Raw materials or intermediates used in the production of pharmaceuticals, pesticides, veterinary drugs, cosmetics, food additives, feed, feed additives, fertilizers and other products;
2) New chemical substances contained in intermediate products or products with specific functions such as surfactants, plasticizers, preservatives, dispersants, flame retardants, etc.; polymers;
3) Substances intentionally released in articles;

Type of new chemical substance declaration:

According to the nature of substances and different tonnages, the types of declaration of new chemical substances can be divided into three categories: regular registration, simple registration and filing:

(1) Regular registration: If the annual production volume or import volume of a new chemical substance is 10 tons/year or more, regular registration is required.
(2) Simplified registration: new chemical substances produced or imported in an annual amount of 1 ton/year or more than less than 10 tons/year, need to apply for simplified registration.
(3) Filing: Polymers or polymers of low concern less than 1 ton/year and containing no more than 2% of monomer or reactant of the new substance are required to be filed;

Exemptions from filing of new chemical substances: Consulting Hotline: 135 2473 3472

Substances exempted from the declaration of new chemical substances are mainly manufactured products already managed by other laws and regulations, naturally-occurring substances, categories of non-commercial purpose or non-intentional production, and other special categories, as follows:

(1) Manufactured products already managed by other laws and regulations: pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, feed and feed additives, radioactive substances, fertilizers, military products, pyrotechnic products and tobacco;

2) Naturally occurring substances;

3) Non-commercial purposes or categories not intentionally produced;

4) Impurities, by-products, waste, etc;

5) Manufactured products that clearly have other laws and regulations governing them are intended to be changed to other industrial uses;

(6) Alloys, non-separated intermediates, articles, etc;