Provisions on the Environmental Administration of New Chemical substances (reference translation)

Issued by: The State Environmental Protection Administration of P. R. China; Issued on: 12 September 2003; Effective as of: 15 October 2003 
 

Chapter 1 General Provisions  
 

Article 1

This Provisions is formulated for the purpose of enhancing the environmental management on new Chemical substances, preventing environmental pollution, and protecting human health and safeguarding the ecological environment.  
 

Article 2

This Provisions is applicable to activities in relation to the manufacture or import of new Chemical substances and their environmental management undertaken within the territory of the People’s Republic of China.  
 

Article 3

The State shall, for the purpose of the environmental management of new Chemical substances, establish the systems of notification and registration applied to any of the manufacture or import of new Chemical substances.

Any manufacturer or importer of new Chemical substances shall, prior to the manufacture or import of new Chemical substances, make notifications and applications for the registration certificates for the environmental management on new Chemical substances (hereinafter cited as ‘the registration certificates’) in accordance with relevant provisions of this Provisions.

The aforesaid provision shall not be applied to the Chemical substances which have been manufactured or imported before the effective date of this Provisions.  
 

Article 4

The term ‘new Chemical substance’, as used in this Provisions, means any Chemical substance which has not yet been manufactured or imported in China before the date on which it is notified.

The State Environmental Protection Administration of the People’s Republic of China (hereinafter cited as ‘the SEPA’) is responsible for compiling and timely publicizing the inventory of Chemical substances manufactured or imported in China.  
 

Article 5

The SEPA is empowered to formulate and promulgate relevant standards and technical requirements for the environmental management of new Chemical substances.  
 

Article 6

The SEPA shall establish a Expert Committee on the Environmental Management on New Chemical Substances (hereinafter cited as ‘The Expert Committee’).

The main responsibility of the Expert Committee is to evaluate the environmental impacts on new Chemical substances and, after evaluation, submit reports in written form on the evaluation results to the SEPA.  
 

Article 7

Any administrative department or person involved in the environmental management of new Chemical substances shall keep the commercial and technical secrets for the notifiers of new Chemical substances (hereinafter cited as ‘the notifiers’).  
 

Chapter 2 Notification  
 

Article 8

The notifiers shall, prior to the manufacture or import of new Chemical substances, complete and submit the notification forms and the testing reports of new Chemical substances, together with a copy of the document on the qualification of the testing entity(ies), to the Chemical Registration Center of SEPA (hereinafter cited as ‘CRC-SEPA’).

The contents of the notification form shall include information of the new Chemical substance notified: the name(s) and the molecular structure; the method(s) applied in measuring; the use(s) of the new Chemical substance; the scheduled annual amount of manufacture or import; the physi-Chemical properties, toxicological and eco-toxicological characteristics; the measures for accident prevention and emergency responses; and the measures for pollution prevention and elimination and for waste disposal, etc..

In case that the testing data were completed out of China, the testing entity(ies) involved shall have been accredited by qualifications the competent authorities of the country in which the entity(ies) is(are) located.

The eco-toxicological data of new Chemical substances shall include those obtained through biological tests performed in China by the application of China’s test organisms. 
 

Article 9 

The notifiers who provide information materials containing commercial and technical secrets shall give confidential indications at the relevant items in the materials. 

The notifiers who will uncover the secrets which is mentioned in aforesaid item shall inform CRC-SEPA in written form.  
 

Article 10

The notifiers may make a serial notification on the new Chemical substances with similarities in molecular constitutions, similarities or sameness in use(s) and testing data, whereas the registration certificate shall be applied for each new Chemical substance.  
 

Article 11

In case that two or more notifiers make a joint notification on the same new Chemical substance, each notifier shall apply for a registration certificate separately.  
 

Article 12

In notifying a new Chemical substance which has been included in the inventories of existing Chemical substances in at least four countries or regional economic integration organizations, the notifier is only required to complete and submit the notification form and the report of eco-toxicological testing performed in China.  
 

Article 13

In one of the following cases, the notifier may apply for exemption from the notification:

(a)            The annual amount of manufacture or import of the new Chemical substance does not exceed 100 kilograms and they are only used for scientific research purpose;

(b)            A polymer containing a new Chemical substance monomer less than 2% (w/w);

(c)            The total amount of the manufacture or import of a new Chemical substance does not exceed 1,000 kilograms and they are specifically used for technologies research and development. In this case, the manufacturer or importer may apply for one-year exemption from notification and no extension will be granted;

(d)            Samples of new Chemical substances imported for the purpose of performing the eco-toxicological tests in China as required by this Provisions.

Any notifier intending to apply for the exemption from notification shall submit the application form for exemption from notification to CRC-SEPA and provide the necessary documents demonstrating the conformities to the aforesaid provision and s/he is obliged to keep a record of the information on the scientific research of the substance, the research and development of relevant technologies, the quantities of the substance manufactured or imported, the names of the customers, and others.  
 

Chapter 3 Registration  
 

Article 14

CRC-SEPA shall, within 15 days after recepting notification materials, complete the format check on the notification materials in accordance with relevant provisions of this Provisions, inform the notifiers in written form that their notification materials are in conformity with the format requirements provided for in this Provisions and thus accepted; or inform the notifiers in written form that their notification materials are not in conformity with the format requirements provided for in this Provisions and thus rejected.

CRC-SEPA shall, if finding the notification materials incomplete or not in conformity with the format requirements provided for in this Provisions, inform the notifier in written form, in one time, all components which shall be supplemented or corrected.

CRC-SEPA shall submit the accepted notification materials, within 5 days after they were accepted, to the Expert Committee.  
 

Article 15

The Expert Committee shall, within 60 days after received the notification materials, proceed the evaluation on the environmental impacts of the new Chemical substances in accordance with relevant standards and technical requirements for the environmental management on new Chemical substances adopted or issued by the SEPA and then submit the evaluation reports in written form to the SEPA.  
 

Article 16

The SEPA shall, within 30 days after received the evaluation reports from the Expert Committee, make the decisions on whether to approve the application for notification. Those whose applications for notification have been approved will be awarded the Registration Certificates and those whose applications for notification were rejected will be given explanations.

The SEPA shall inform CRC-SEPA its decisions and CRC-SEPA is responsible for forwarding the decisions in written form to notifiers.  
 

Article 17

CRC-SEPA shall, within 15 days after received the application for the exemption from notification, make suggestions on decisions and submit them to the SEPA for review and audit.

The SEPA shall, within 15 days after received the application materials and the suggestions on decisions, make decisions on whether to approve the application for exemption from notification and inform CRC-SEPA its decisions. CRC-SEPA is responsible for forwarding the decisions to the notifiers in written form.  
 

Article 18

The SPEA shall, after having made decisions on the registration or the exemption from notification in accordance with Artical 16 and Article 17 respectively, inform its decisions and transmit the notice on the supervision and inspection over environmental impacts of new Chemical substances to the environmental protection administrative departments at the provincial level where the manufacturers or importers concerned are located.

The provincial environmental protection administrative departments shall transmit the decisions and the notices aforesaid to the environmental protection administrative departments of the counties or municipalities where the manufacturers or importers of the new Chemical substances are located.

Chapter 4 Supervision and Management  
 

Article 19

Any holder of the registration certificates shall, within 5 days after each batch actually manufactured, imported or transferred new Chemical substances to users, fill in and submit a record form on manufacture, import or circulation of new Chemical substances to the environmental protection administrative department of the county where the manufacturer or importer is located.