Background

The "Measures for the Environmental Management Registration of New Chemical Substances" was reviewed and approved by the Ministry of Ecology and Environment on February 17, 2020, and was promulgated on April 29, 2020, and came into effect on January 1, 2021. The "Measures for the Environmental Management of New Chemical Substances" (Order No. 7 of the Ministry of Environmental Protection) issued by the former Ministry of Environmental Protection on January 19, 2010 shall be repealed simultaneously. According to the provisions of the "Measures", companies must register new chemical substances before production or import of new chemical substances in China, and obtain the environmental management registration certificate for new chemical substances before they can legally produce or import new chemical substances.

Applicant

1. Domestic enterprises and institutions that intend to engage in the production or import of new chemical substances；

2. Production or trading companies that intend to export new chemical substances to China can also serve as applicants, but they need to appoint a local agent；

3. If the products such as pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers, etc., as defined in Article 2 in the “Measures”, are new chemical substances and are intended to be changed for other industrial uses, the relevant producers, importers or processing users may be the registrant；

4. For chemical substances listed in the “IECSC” and subject to environmental management of new usage, if they are intended to be used for other industrial uses other than permitted uses, the manufacturer, importers or processing users of the related chemical substances may be the registrant.

Registration Scope

New chemical substances refer to the chemical substances not listed in “The Inventory of Existing Chemical Substances in China” (hereinafter referred to as the “IECSC”).

Registrants need to fulfill the obligation to register new chemical substances that are not listed in the "IECSC". New chemical substances contained in preparations and new chemical substances intentionally released from articles should also be subject to the registration.

Raw materials or intermediates for the production of medicines, pesticides, veterinary drugs, cosmetics, food additives, feeds, feed additives, fertilizers and other products that are new chemical substances must also be registered. Chemical substances that have been listed in the “IECSC" but require environmental management for new uses, should be registered if they are used for industrial purposes other than permitted uses.

Exemption scope

Pharmaceutical (including API), pesticide (including New AI), veterinary drug (including API), cosmetics, food, food additive, feed, feed additive, fertilizer and other products；

Radioactive substance；

Natural substances；

Substances not for commercial purposes or unintentionally produced: Impurities, byproduct, waste etc.;

Other special categories: alloy, non-isolated intermediates, articles, Mixtures that are artificially mixed by existing chemicals and do not produce new chemicals, Chemicals substances in anhydrous form that have been listed in the “IECSC” or registered.

Registration type

New chemical substance registration approval process

Post registration management

Regular registration

1. New use registration

1)    The substances included in the "IECSC", and has environmental management requirements for new uses;

2)    The substances are to be used for other industrial purposes other than those permitted in the "IECSC"; and the applicant has not obtained the regular registration certificate for the intended use for hazardous chemical substances.

2. Re-registration

1)    The volume of production or import is planned to exceed the register tonnage limit;

2)    Type of activity intended to be converted from import to production;

3)    Intending to change and update the use for the chemical substance;

4)    Planning to change the environmental risk control measures;

5)    Other situations that lead to increased environmental risks.

Registration certificate changes

Applicant/ agent name change, agent change, the type of activity is to be changed from production to import or the type of activity is to be increased with imports, change of identification information.

Simplified registration

Registration certificate change: the applicant/agent name change, agent change, change of the chemical identification information, change of registration volume, activity type, use and environmental risk control measures.

Withdrawal of the application: After submitting the application of new chemical substances for environmental management registration, the applicant can submit a written application for withdrawal of registration, stating the reason for the withdrawal before it is approved；

Cancellation of the certificate: the applicant can apply for cancellation of registration certificate with written cancellation application.

Note: After the cancellation, the holder of the original registration certificate shall not reapply for registration of the same new chemical substance within three years.

Post registration management

Inclusion of chemical substances in the “IECSC”

1. Chemical substances that have been produced, sold, processed or imported in China before October 15, 2003 can apply for supplementation at any time；

2. New chemical substances that have obtained a regular registration certificate under MEE Order No. 12, five years from the date of first registration, will be listed by an announcement (the regular registration certificate that has been applied for cancellation is also applicable) ；

3. Substances registered under Decree No. 7 shall be announced and listed after five years after the first activity or five years after the implementation of MEE Order No. 12；

4. Substances registered under SEPA Order No. 17 will be listed within six months after the implementation of MEE Order No. 12；

Supervision and spot check

The competent department of Ministry of Ecology and Environment shall notify the competent department of ecology and environment at the provincial level of the environmental management registration of new chemical substances, environmental risk control measures and requirements for environmental management, the first activity and the annual report; the competent department of ecological environment at the provincial level shall notify the aforesaid information to the competent department of ecology and environment at the municipal level divided into districts.

The competent department of ecology and environment at the municipal level divided into districts shall conduct supervision and random inspection on whether the producers, importers and processing users of new chemical substances have handled the environmental management registration of new chemical substances as required, the authenticity of the registered items, the implementation of the items prescribed in the registration certificate and other relevant provisions of the Measures.

Researchers, producers, importers and processing users of new chemical substances shall truthfully provide relevant information and accept the supervision and random inspection by the competent department of ecological environment.

Our Services

Regulations consultation on new chemical substance management

Affirmation for new chemical substances

New chemical substance registration service (record, simple registration, regular registration)

Test placement and monitoring

New chemical substance risk assessment report

Post registration management

Customer tailored training

Our advantages

More than 20 years of experience in chemical regulations and technical consulting, providing customers with value-added services

More than 200 middle and senior experts with professional technics in the fields of chemical engineering, toxicology, medicine, etc.

Powerful literature and information resources

High quality cooperative laboratory resources