New chemical substances registration in China

The Ministry of Environmental Protection of The People's Republic of China (MEP) issued the revised "Environmental Management Measures for New Chemical Substances" (hereinafter referred to as "The Measures") in January 2010, namely Ministry Decree No.7, and the Measures came into effect on October 15, 2010. "Method" regulation enterprise within the territory of China before the production or import of new chemical substances to the territory of China, must, in accordance with the methods of was not included in the list of China's existing chemicals (i.e. the IECSC) chemicals for new chemical substance notification, after get new chemical environmental management registration certificates, to develop new chemical substance manufactured or imported.

 Application scope

New chemical substances not included in the List of Existing Chemical Substances in China (hereinafter referred to as the List) include the following

Raw materials or intermediates used in the production of pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, feed additives and other products

Substances intentionally released from intermediates with specific functions such as surfactants, plasticizers, preservatives, dispersants and flame retardants or from new chemicals contained in the products

 The exceptions

Manufactured goods already regulated by other laws and regulations: medicines, pesticides, veterinary drugs, cosmetics, food, food additives, feed and feed additives, radioactive substances, military products, fire products and tobacco and other substances naturally occurring

Non-commercial or non-intentional production: impurities, by-products, wastes, etc

Other special categories: alloys, non-separating intermediates, articles, etc

 Registered substance

Note: If the applicant is a domestic applicant, he/she may directly or entrust others to handle the registration of new chemical substances; If the applicant is an overseas applicant, he/she shall entrust a domestic registered institution to handle the registration of new chemical substances.

Raw materials or intermediates used in the production of pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, feed additives and other products

A domestic registration institution that intends to engage in the import of new chemical substances

It is proposed to change the domestic registration authority that has been listed in the List of key environmental management USES for new hazardous chemical substances

Foreign manufacturers intending to export new chemicals to China

 Registration type

Scientific research record

Import of samples of new chemical substances for ecotoxicological tests in China using Chinese tested organisms for production or import of less than 0.1 t/a for scientific research purposes

Simplified registration

Base case: annual production or import volume of new chemical substances < 1 ton

Special case: used as intermediate or for export only, annual production or import volume <1 ton

For the purpose of scientific research, 0.1 ton ≤ annual production or import <1 ton

Polymers with less than 2% monomers of new chemical substances or polymers of low concern (unlimited tonnage)

Annual production or import of less than 10 tons, not exceeding two years, for the purpose of research and development of processes and products

 Regular registration

Annual production or import of new chemical substances ≥1 ton

According to the tonnage of the declared substance, it is divided into four declaration levels: 1-10, 10-100, 100-1000 and 1000+ (tons/year)

 Post-registration obligation

After assessment, new chemicals are usually classified into three categories: general, hazardous, and key environmental management new chemicals. The Ministry of Environmental Protection of the People's Republic of China and local environmental protection departments shall implement differentiated classification management for different categories of new chemical substances. Holders of new chemical substance registration certificate shall generally fulfill the following obligations

Our services

1. Comprehensive consultation on regulations and new substance search services

(1) Professional regulatory consulting services

(2) New Chemical Substance Search service (IECSC Open Library query, commissioned to search for new substances)

2. Agency service for new chemical substance registration

(1) Registration agent services

(2) New chemical substance registration Service (scientific research record/simplified registration/regular registration)

(3) Apply for overall program customization

(4) Material data assessment/gap analysis/exemption analysis

(5) Laboratory test supervision service

(6) Risk assessment report preparation

(7) Communication and consultation with competent departments/experts

(8) Translation of regulatory documents and application materials

3. the registration of agent maintenance services

(1) Post-registration service for new chemical substances

(2) Regulations training service