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Interpretation of the main points of the Guidelines for the Registration of Environmental Management of New Chemical Substances (Draft for Comments)
Release time:
2020-08-19 11:47
On April 29, 2020, the Ministry of Ecology and Environment officially issued the revised Measures for the Registration of Environmental Management of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment, hereinafter referred to as the Measures). After the formal promulgation and implementation of the measures, people from all walks of life have paid great attention to the detailed rules for its implementation.
On August 17, the Ministry of Ecology and Environment finally issued the "Guidelines for the Registration of Environmental Management of New Chemical Substances (Draft for Comment)" (hereinafter referred to as the "Guidelines"), and publicly solicited opinions. The deadline for soliciting opinions is September 6, 2020.
The guide is a supporting normative document for the implementation of the measures, which refines the relevant provisions of the measures and defines the specific implementation requirements. This guide mainly includes registration scope, registration type, registration procedure, registration application material requirements, polymer special provisions and new use environmental management registration, re-registration, registration certificate change, withdrawal and cancellation, and post-registration tracking management.
New Anrun Consulting has combed and interpreted the contents of general concern in the industry, hoping to learn and discuss with you.
Registration scope
Clear raw materials, pesticides, not applicable to the Measures.
Chemical substances that have been listed in the Directory and are subject to environmental management for new uses, and are used for industrial uses other than permitted uses, are required to be registered;
Medicines (including raw materials), pesticides (including pesticide technical drugs), veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers and other products that are changed to other industrial uses, as well as raw materials or intermediates used in the production of the above-mentioned products, which belong to new chemical substances, shall be registered.
Applicant
The applicant is the subject of the environmental management registration of new chemical substances and is the holder of the registration certificate. The agent ceases to be the holder of the certificate of registration.
If the medicines, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers and other products specified in Article 2 of the Measures belong to new chemical substances and are intended to be changed to other industrial uses, the producers of related products, Importers or processing users can be used as applicants.
For chemical substances that have been listed in the "List" and are subject to environmental management for new uses, if they are intended to be used for other industrial uses other than permitted uses, the producers, importers or processing users of the relevant chemical substances can be the applicants.
Registration Type
regular registration: annual production or import volume of more than 10 tons;
Simple registration: annual production or import volume of more than 1 ton less than 10 tons;
Filing: One of the following conditions is met:
The annual production or import of new chemical substances is less than 1 ton;
Polymers with a monomer or reactant content of no more than 2% of the new chemical substance or polymers of low concern (requirements are not excluded from polymer filing).
Application Information Requirements
Registration Type | Information Requirements |
regular registration | regular registration application form; Attachments to the application form (including: legal person certificate or business license, agency contract or agreement, power of attorney; Test report or data; Environmental risk assessment report; Social and economic benefit analysis report (belonging to high-hazard new chemical substances); Information protection necessity description materials; Commitment letter for implementing or transmitting environmental risk control measures and environmental management requirements; Other information on environmental and health hazard characteristics and environmental risks that have been mastered, etc.) |
simple registration | simplified registration application form; Attachments to the application form for simple registration (including: legal person certificate or business license, agency contract or agreement, power of attorney; Test report or data; judgment conclusion and basis of persistence, bioaccumulation and toxicity of the application substance; information protection necessity description materials; commitment letter for implementing or transmitting environmental risk control measures; other information on environmental and health hazard characteristics and environmental risks that have been mastered, etc.) |
Filing | Filing form; Attachments to the filing form (including: legal person certificate or business license, agency contract or agreement, power of attorney; For polymer filing, supporting materials conforming to the corresponding situation shall be submitted; Information protection necessity explanation materials; Other information on environmental and health hazard characteristics and environmental risks that have been mastered, etc.) |
Disapproval of technical review
regular registration | simple registration | |
Same terms | 1. There is concealment or fraud in the process of registration application; 2. The name or identification information is incorrect; 3. The test report or information does not meet the requirements or is of poor quality; 4. Failure to submit additional relevant test reports or data within 6 months. | |
Different terms | (1) The contents of the environmental risk assessment report are not sufficient to make a comprehensive assessment of the environmental risks of new chemical substances; 2. The environmental risk assessment finds that there are unreasonable environmental risks or environmental risk control measures are inappropriate; Does not meet the requirements of the necessity of high-hazard chemical substance application activities. | 1. The application substance is persistent, bioaccumulative and toxic at the same time; 2. There is a cumulative environmental risk.
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Testing Agency Qualification
Within the territory | Basic requirements | Acquire the qualification of inspection and testing institutions according to law |
Ecotoxicology | Compliance with Good Laboratory Management Practices (GLP) and the relevant requirements of the Ministry of Ecology and Environment for the management of chemical testing institutions | |
Health Toxicology | Institutions that have passed the (GLP) certification management of the State Food and Drug Administration for non-clinical research, chemical toxicity identification institutions that have passed the quality assessment of the Chinese Center for Disease Control and Prevention, pesticide registration and testing units announced by the Ministry of Agriculture and Rural Affairs, and institutions that have passed the (GLP) evaluation of good laboratory practices approved by the China National Certification and Accreditation Administration | |
Overseas | Physical Chemistry | Accreditation of ISO 17025 standards or good laboratory management practices (GLP) |
Health Toxicology/Ecotoxicology | Internationally accepted good laboratory management practices (GLP) |
Data Requirements
regular and summary registrations should submit at least the corresponding minimum requirements data according to the type of registration, and special requirements data should also be submitted according to the type of registration for those with persistent (P) and bioaccumulative (B) related characteristics.
regular Registration:
The minimum required data include physicochemical properties, health toxicology and ecotoxicology basic data.
Further Health Toxicology and Ecotoxicology Special Requirements data shall be submitted for substances in category P or B.
Simple Registration:
The minimum required data include basic data on physicochemical properties, persistence, bioaccumulation and acute toxicity in the aquatic environment.
Substances that are both persistent and bioaccumulative (PB) should be further submitted with specific requirements for chronic toxicity in the aquatic environment.
For specific requirements, please refer to the Guide.
2 Physical and chemical data requirements
Compared with order 7, the data requirements related to the classification of physical hazards such as oxidation, flammability, explosiveness, flash point and spontaneous combustion temperature are reduced. Under the regular registration, data requirements for stability in organic solvents and characteristics of degradation products, dissociation constants, and Henry constants have been added, and data for substances in different states have also been adjusted.
Health Toxicology Data Requirements
Simple registration, no need to submit health toxicology data.
regular registration, non-P/B substances require the submission of minimum required data, which is close to regular level II under the current Order 7. For P or B substances, the data requirements are higher, and the data requirements are close to the regular level 4 under the current order 7.
Mutagenicity tests: Data requirements are more specific, but in vivo chromosome damage data have been added to the three basic tests.
Toxicokinetics: no health hazard effect, no need to submit toxicokinetics test data or information; PBT and vPvB substances (with health hazard effects, excluding local toxicity) should submit a comprehensive toxicokinetics test report
² Ecotoxicological data requirements
Simple registration: general class substances, need to submit acute aquatic three, degradation and bioaccumulation. For class PB substances, aquatic chronic toxicity data are also required.
regular registration: General substances, data requirements are close to regular level 2 under the current order 7. For P/B substances, the data requirements are close to regular IV under the current Order 7, with new data requirements for chronic toxicity of benthos.
Adjusted the test items that need to be completed with Chinese test substances, including: fish acute toxicity and fish chronic toxicity, activated sludge respiratory inhibition toxicity test, aquatic bioaccumulation test, and biodegradability data.
High Hazardous Chemicals
The "Guide" clearly gives the definition and determination criteria of highly hazardous chemical substances.
Definition: Highly hazardous chemicals are chemicals that are both persistent, bioaccumulative and toxic, chemicals that are both highly persistent and bioaccumulative, or other chemicals that are equally hazardous to the environment or health.
Determination criteria and screening methods for PBT and vPvb substances
If the existing data are not sufficient to support the determination criteria, the screening criteria are specified in conjunction with the registration application data requirements, I .e. those that cannot be excluded from persistence, bioaccumulation or toxicity according to the screening criteria shall be deemed to have the above characteristics, unless the applicant voluntarily submits additional data.
2 Determination of highly hazardous chemicals with equivalent environmental or health hazards: including but not limited to endocrine disrupting chemicals (EDCs) and extremely toxic (acute or chronic) substances.
Environmental Risk Assessment Report
Environmental risk assessment is required to be carried out in a quantitative manner, and specific requirements such as hazard assessment, exposure assessment (exposure scenario construction, emission estimation), and environmental risk characterization are specified.
The hazard assessment shows that the application substance has no classification of ecological environment and human health hazards, and does not have persistence and bioaccumulation. If the application amount is less than 100 tons, no follow-up environmental risk assessment is required.
For new chemicals belonging to the PBT and vPvB classes. The focus is usually on the identification of emission and exposure characteristics, that is, the identification of the release of PBT and vPvB chemicals to the environment throughout the life cycle, as well as all possible exposure routes of the chemical to humans and the environment. On the basis of the above, measures to reduce emissions and exposure to humans and the environment are proposed.
Analysis report of social and economic benefits
For highly hazardous chemical substances, a socio-economic benefit analysis report is required. The socio-economic benefit analysis report shall explain the new chemical substance activity scenario and the chemical substance activity scenario in use under the application, analyze and evaluate the impact comparison of the two scenarios from the aspects of environment, health, economy and society, and fully demonstrate the necessity of the application activity. The chemical substance in use under the application shall cover all chemical substances in use under the current domestic use.
The necessity of new chemical substance activities includes that the economic and social benefits of new chemical substance activities exceed the risks to human health and the environment, and at the same time, compared with all chemical substances in use, the human health and environmental impacts and economic and social benefits of new chemical substance activities have considerable or obvious advantages.
The impacts of chemical activity cover the full life cycle stages of production, formulation, industrial use, consumer use and waste disposal.
Quantify and monetize the relevant impacts as much as possible, and for impacts that cannot be quantified, a qualitative description of the expected severity and extent of the impact can be provided.
Information Protection
When the applicant needs information protection, it shall submit the materials explaining the necessity of applying for the protection of trade secret information. The description of the necessity of information protection shall set out the specific information columns for which protection is applied, and shall be explained one by one against the 12 situations (see the Guide for details).
The validity period of identification information such as the name of the chemical substance shall not exceed five years from the date of first registration or filing.
Chemical substances that do not have the classification of environmental hazards and health hazards, and the identification information such as the name of the chemical substance has been granted protection, may apply for the extension of the protection of the identification information such as the name of the chemical substance, and the extension period shall not exceed five years.
The same applies to new chemical substances that have obtained a new chemical substance environmental management registration certificate under the current No. 7.
Special provisions for polymers
Polymers that meet one of the following conditions should be registered for regular or simple registration, and cannot be filed for the record.
² Cationic polymers or those that are expected to become cationic polymers in natural water environments
Degraded or unstable polymers, including polymers that are easily degraded, decomposed, depolymerized, and polymers that decompose after production or use
² Water-absorbent polymers with a number-average molecular weight of 10,000 daltons or more
² Polymers containing perfluoroalkyl groups covalently bonded to carbon or sulfur atoms, such as polymers containing perfluoroalkyl sulfonic acid groups, perfluoroalkyl carboxylic acid groups, fluorine-containing telomers, etc.
In addition to impurities, containing other elements other than the following allowed elements
Post-Registration Activity Report
First activity report: the holder or agent of the registration certificate, within 60 days from the date of the first production activity or the first import and transfer to the processing user.
Annual report: If the regular registration certificate stipulates the requirements for submitting an annual report, the holder of the registration certificate or his designated agent shall submit an annual report on new chemical substances before April 30 of each year starting from the year following the date of registration.
Inclusion in the Directory
Chemical substances that have been produced, sold, processed, used or imported in China before October 15, 2003: you can apply to join the list through the online registration system.
New chemical substances that have obtained the regular registration certificate shall be listed in the "List" for five years from the date of first registration.
New chemical substances that have obtained the regular declaration and registration certificate under the Environmental Management Measures for New Chemical Substances (Order No. 7 of the Ministry of Environmental Protection): As of January 1, 2021, there have been actual production or import of new chemical substances but less than five years After five years from the date of the first production or import activity, the Ministry of Ecology and Environment announced to be included in the "List." As of January 1, 2021, if there is no actual production or import of new chemical substances, five years from the date of implementation of the "Measures", the Ministry of Ecology and Environment will announce that it will be included in the "List."
If a new chemical substance that has obtained a normal declaration and registration certificate under the "Measures for the Environmental Management of New Chemical Substances" (Order No. 17 of the State Environmental Protection Administration) has not been included in the "List", within six months from the date of implementation of the "Measures", The Ministry of Ecology and Environment announced the inclusion in the "List".
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