To further optimize measures on environmental management of new chemical substances, the ministry of Ecology and Environment has revised Measures on Environmental Management of New Chemical Substances (Decree No.7 of the Ministry of Environmental Protection) (” Decree No.7”) and produced a draft open for public comments. All organizations, enterprises and institutes and individuals may make comments and suggestions in the required feedback forms. The deadline is 16 August 2019. With nine key words here, BoardingCard will help you better understand the contents of the revised draft of Decree No.7. If you have relevant comments or suggestions, you can also contact BoardingCard. BoardingCard will summarize opinions or suggestions and made corresponding feedback together.

 

 

A【Inventory of Existing Chemical Substance in China】
 

1.New chemical referred in this Measure means the chemical not listed in Inventory of Existing Chemical Substance in China (“IECSC”), and the chemical listed but has a new usage other than the restricted ones.

 

2.“IECSC” is formulated, adjusted and published by the competent department for ecological environment under the State Council, including chemical substances that had been legally produced or imported to China before October 15th , 2003, as well as those substances listed in accordance with relevant regulations on environmental management.

 

3.When chemicals listed in IECSC and managed on new use are planned to be applied in new usage, the researcher, producer, importer or user of processing may act as an applicant.

 

4.New chemical substances of full registration shall be published by the competent department for ecological environment under the State Council and listed in the IECSC after five years from the date of initial registration, including those new chemical substances whose registration have been cancelled.

 

5.Where a registration certificate contains the requirements for new use management, the new use management requirements shall be specified when it is listed in the IECSC. For non-highly hazardous chemical substances approved for new uses whose new uses shall be listed in the IECSC and published.

 

6.New chemical substances for simplified registration and record notification, as well as fully registered new chemical substances that have been revoked shall not enter the IECSC.

 

7.Chemical substances with full registration certificate obtained under Decree No.7 shall be announced by the competent department for ecological environment under the State Council and listed into IECSC after five years from the date of the activity or five years from the date of implementation of the Measures.

 

8.Within six months of the implementation of the Measures, those chemical substances that obtained certificates under Decree No. 17 shall be published by the competent department for ecological environment under the State Council and enter the IECSC.

 

B【 New Use Management】
 

1.New chemical referred in this Measure means the chemical not listed in IECSC. Chemical substances, which have been listed in the IECSC, but subject to new use management, and intended for other industrial purposes beyond the permitted ones, shall be governed by this measure.

 

2.When chemicals listed in IECSC and managed on new use are planned to be applied in new usage, the researcher, producer, importer or user of processing may act as an applicant.

 

3.One of eight key points when doing full registration technical review and vetting: When entering IECSC, whether subject to new use management or not

 

4.For full registration certificates of highly hazardous new chemical substances, whether to include request for new uses management when entering IECSC shall be considered; If the registration certificate contains the requirements for the management of new uses, the new use management requirements shall be stipulated when listed in the IECSC.

 

5.When a chemical substance has been listed in the IECSC, but is subject to new use management, and is intended for other industrial purposes beyond the permitted uses, the applicant shall submit an application form, an exposure assessment report and risk control measures for the new use of the chemical substance before research, production, import or processing and use to the competent department for ecological environment under the State Council. For highly hazardous chemical substances, a social and economic benefit analysis reports shall be submitted as well to fully demonstrate the necessity of new use.

 

C【Highly Hazardous New Chemical Substances】
 

1.Highly hazardous chemical substances are those with persistence, bioaccumulation and toxicity (PBT), or with very persistence and very bioaccumulation (vPvB) or other chemicals with equal hazardous.

 

2.When filing full registration, besides application form, test reports or materials on physicochemical properties, health toxicology and ecotoxicology, for new chemical substances with persistence or bioaccumulation, it also requests test reports or material on long-term chronic toxicity of health toxicology and ecotoxicology, unless no exposure is proved. For substance that is PBT, vPvB or equivalently hazardous, a social and economic benefit analysis reports shall be submitted, including a statement showing the new chemical substance has a competent or larger advantage over other chemical substances with similar use in the aspects of performance, environment- friendly, fully demonstrating the necessity of application.

 

3.One of eight key points when doing full registration technical review and vetting: the necessity of filing registration for Highly Hazardous New Chemical Substances (if any).

 

4.The decision on full registration for new chemical substances: Where appropriate risk control measures are taken and no unreasonable risks are found, and the necessity of applying for highly hazardous new chemical substances is acceptable, a registration shall be approved, and a registration certificate shall be issued. For highly hazardous new chemical substances, when the necessity of application activity is unacceptable, the registration will be denied.

 

5.For highly hazardous new chemical substances and PB, PT, or BT, a full registration certificate shall contain one or more of the following environmental management requirements: i. Limit quantity or concentration of discharged new chemical substances; ii. Requirements for new use management when listed in the IECSC. Iii. Submission of annual reports; iv. Other environmental management requirements.

 

D【Full Registration】
 

1.Where the annual production volume or import volume of new chemical substances is 10 T or more, it shall be subject to Full Registration.

 

2.For the full registration of new chemical substances, the applicant shall submit an application form, test reports or materials on physicochemical properties, and basic properties of health toxicology and ecotoxicology of the new chemical substance, as well as application materials such as risk assessment reports. The test reports and materials in the application shall meet the needs of risk assessment of the new chemical substance.

 

3.For new chemical substances with persistence and bioaccumulation, test reports or information on long-term chronic toxicity of health toxicology and ecotoxicology shall also be submitted. However, it is an exception for new chemical substances of which no exposure is proved. For highly-hazardous new chemical substances that are persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) or equivalently hazardous, socio-economic benefit analysis materials shall be submitted, including a statement showing whether the new chemical substances have a comparable or obvious advantage in terms of performance, environmental friendliness, etc. compared with the chemical substance in use for the applied purpose, to fully demonstrate the necessity of the application activity.

 

4.The ecotoxicological test reports shall include test data completed in China using Chinese organisms in accordance with relevant standards

 

5.The technical agency for environmental management of chemical substances and expert review committee will shall conduct technological audit and review of the following contents, (I) Name and identification; (II) Data quality; (III) Environmental and health hazard characteristics; (IV) Exposure status, and environmental and health risks; (V) Whether new use management is implemented when listed in the Inventory of Existing Chemical Substances in China; (VI) Whether risk control measures are appropriate; (VII) The necessity of applying for highly-hazardous new chemical substances (if any); (VIII) The necessity of protecting trade secrets or technical secrets (if any).

 

6.The review opinions shall include a review conclusion for the above items, as well as recommendations on approval of registration, and on environmental management requirements. Where the technological audit and review considers that the quality of existing application materials does not meet the requirements, or is insufficient to fully assess the risks of new chemical substances, the applicant may be required to supplement materials, and a time limit for supplement shall be agreed upon.

 

7.The competent department for ecological environment under the State Council shall initiate technological audit and expert review of new chemical substances within 5 working days from the date of accepting an application. The technological audit and expert review involved in full registration shall not exceed 60 days. The time required for the applicant to supplement application materials shall not be included in the technological audit and expert review time. The competent department for ecological environment under the State Council shall, within 15 working days from the date of receiving review opinions on new chemical substances, make a decision on whether to make a registration. Where a decision cannot be made within 15 working days, it may be extended by 10 working days with the approval of the person in charge of the competent department for ecological environment under the State Council, and the applicant shall be informed of reasons for the extension of the time limit. A registration certificate shall be issued within 10 working days from the date of a registration decision.

 

8.For new chemical substances with a full registration certificate, before being listed in IECSC, the applicant can apply for a change of registration certificate. After an applicant has obtained a registration certificate for new chemical substances, it may apply to the competent department for ecological environment under the State Council for cancellation of the registration certificate.

 

9.The producers and processing users of full registration of new chemical substances shall implement the risk control measures and environmental management requirements. Risk control measures and environmental management requirements and their implementation shall be made public through the official website or other means known to the public.

 

10.The applicant for the registration certificate shall report the first activity of new chemical substances to the competent department for ecological environment under the State Council within 30 days of the first production activity or within 30 days after the first import and transfer to the processing user.

 

Where the submission of annual report is required by the environmental management requirements on the full registration certificate, the applicant shall, from the next year of the registration date, report to the competent department for ecological environment under the State Council before April 30 of each year on the actual production or import of new chemical substances approved in the previous year, the discharge in the environment, and the implementation of risk control measures and environmental management requirements.

 

11.New chemical substances of full registration shall be published by the competent department for ecological environment under the State Council and listed in IECSC after five years from the date of first registration.

 

E【Simplified Registration】
 

1.Where the annual production volume or import volume of new chemical substances is less than 10 T but above 1 T (inclusive), simplified registration shall be handled.

 

2.For the simplified registration of new chemical substances, the applicant shall submit an application form, test reports or materials such as physicochemical properties, persistence, bioaccumulation and acute toxicity in aquatic environment. For substances with persistence and bioaccumulation, test data or information on chronic toxicity in aquatic environment shall also be submitted.

 

3.The ecotoxicological property test report shall include test data completed in China using Chinese species offered for test in accordance with relevant standards.

 

4.The technical agency for environmental management of chemical substances and expert review committee will shall conduct technological audit and review of the following contents, (I) Name and identification; (II) Data quality; (III) Persistence, bioaccumulation and aquatic environmental toxicity of substances; (IV) Cumulative environmental risks of substances; (V) The necessity of protecting trade secrets or technical secrets (if any).

 

5.The review opinions shall include a review conclusion for the above items, and recommendations on whether or not to approve the registration. Where it is judged that the quality of existing application materials does not meet the requirements, the applicant may be required to supplement materials, and a time limit for supplement shall be agreed upon.

 

6.Technological audit and expert review of new chemical substances shall be launched within 5 working days from the date of accepting an application. The technological audit and expert review involved in simplified registration shall not exceed 30 days. The time required for the applicant to supplement application materials shall not be included in the technological audit and expert review time. The competent department for ecological environment under the State Council shall, within 15 working days from the date of receiving review opinions on new chemical substances, decide on whether to make a registration. Where a decision cannot be made within 15 working days, it may be extended by 10 working days with the approval of the person in charge of the competent department for ecological environment under the State Council, and the applicant shall be informed of reasons for the extension of the time limit. A registration certificate shall be issued within 10 working days from the date of a registration decision.

 

7.Where a new chemical substance has obtained a simplified registration certificate, but its Chinese or English name or its CAS number and other identification information changes, it shall be re-registered.

 

8.For new chemical substances with the simplified registration certificate, if other information recorded in the registration certificate changes, except for identical information and activity type, the applicant shall register for the change.

 

9.The applicant for the registration certificate shall report the first activity of new chemical substances to the competent department for ecological environment under the State Council within 30 days of the first production activity or within 30 days after the first import and transfer to the processing user.

 

10.Simplified Registered substances will not be listed in IECSC.

 

 F【Record Notification】
 

1.Under either of the following circumstances, Notification shall be completed before production or import: (I) The annual production or import volume of new chemical substances is less than 1 T; (II) polymers with lower than 2% new monomers or belongs to polymers of low concern.

 

2.When filing a notification, the applicant shall submit notification form, proof materials in accordance with the corresponding circumstances, and relevant data on the physical and chemical properties, health toxicology and ecotoxicological characteristics of the known new chemical substances and be responsible for compliance with Record Notification situation.

 

3.The competent department for ecological environment under the State Council shall, after receiving the notification materials, archive the complete materials for future reference and send a Receipt. After successfully submitting the notification materials, the applicant can carry out activities related to new chemical substances according to the contents of the application.

 

4.When the related information changes, the applicant shall update the notification information.

 

5.Notified substances will not be listed in IECSC.

 

 G【Research】
 

1.With an annual production volume or import volume of less than 100 Kg, new chemical substances used for the purpose of research shall not be governed by the Measures.

 

2.The research activities of new chemical substances shall be carried out in special facilities and strictly in accordance with relevant management regulations under the guidance of professionals. The new chemical substances produced or imported for research purpose shall be properly preserved and shall not be used for other purposes. In violation of the Measures, the competent local ecological environment departments at or above the municipal level shall order to correct, impose a fine of between 10,000 yuan and 30,000 yuan, publish the violations, incorporate them into the records of environmental violations, and report the punishment to the competent department for ecological environment under the State Council

 

H【Testing Institute】
 

1.The domestic laboratory that provides test data for the registration of new chemical substances shall pass measurement certification. The health toxicology and ecotoxicology testing laboratories shall also comply with good laboratory management practices, and perform tests in strict accordance with relevant national standards for chemical substance testing. The testing laboratory shall be responsible for the authenticity and reliability of test results issued by it, and shall assume legal responsibilities.

 

2.The competent department for ecological environment under the State Council shall supervise and inspect test status and conditions of the ecotoxicology testing laboratory for chemical substances.

 

3.Oversea testing laboratories that produce health or ecotoxicology data shall meet internationally accepted management requirements for good laboratories.

 

4.Any domestic laboratory that forges, tampers with the data or commits other fraudulent acts in the process of testing new chemical substances for the purpose of providing test data for the application of new chemical substances shall be fined from 10,000 yuan to 30,000 yuan by the competent ecological environment department under the State Council, and the test report issued by it shall not be accepted within five years; the laboratory that constitutes a crime shall be investigated for criminal responsibility according to law. Laboratory compliance shall be included in the environmental credit information system and made public.

 

5.Where a laboratory provides false reports, the competent department for ecological environment under the State Council shall impose a fine of not less than 10,000 yuan but not more than 30,000 yuan on the person in charge directly responsible and other persons directly responsible. For serious cases, the test reports that it participates in shall not be accepted within 10 years; if it constitutes a crime, criminal responsibility shall be investigated according to law.

 

I【Cohesion Policies】
 

1.The environmental management registration certificates of full registration under Decree No.7 will still be valid after this Measures in force but shall comply with relevant regulations on the full registration of the Measures. New chemical substance shall be announced by the competent department for ecological environment under the State Council and listed into IECSC after five years from the date of the activity or five years from the date of implementation of the Measures.

 

2.The environmental management registration certificates of simplified registration special or basic circumstance of new chemical substance will be of the same effect as the record receipt stipulated in this Measure after its coming into force. However, when there is any change on content of certificate, record notification shall be filed according to this Measure.

 

3.Prior to the entry into force of this Measures, theses full registrations, simplified registrations that have been accepted but no decisions have made on, may continue processing in accordance with the relevant provision of Decree No.7.

 

4.Within six months of the implementation of the Measures, those chemical substances that obtained certificates under Decree No. 17 shall be published by the competent department for ecological environment under the State Council and enter the IECSC.

 

 

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