Interpretation of Guidance for the Environmental Management Registration of New Chemical Substances（Draft for comments)

On April 29, 2020, the Ministry of Ecology and Environment officially issued the revised "Measures for the Environmental Management Registration of New Chemical Substances" (Ministry of Ecology and Environment Order No. 12, hereinafter referred to as the "Measures"). The promulgation of the implementation rules of the "Measures" has attracted great attention from all walks of life.

On August 17, the Ministry of Ecology and Environment finally issued the Guidance for the Environmental Management Registration of New Chemical Substances (Draft for Comment) (hereinafter referred to as the "Guidance") and publicly solicited opinions. The deadline for comments is September 6, 2020.

The Guidance is a supporting normative document for the implementation of the Measures, which refine the relevant provisions of the Measures and clarify the specific implementation requirements. This Guidance mainly includes the scope of registration, registration types, registration procedures, and requirements for registration application materials, special regulations for polymers, and environmental management registration for new uses, re-registration, and changes of registration certificates, withdrawal and cancellation, and follow-up management of post-registration.

NAR consulting has sorted out and interpreted the content of general concern in the industry, and hopes to discuss with you.

 

Registration scope

It is clarified that APIs and the raw materials of pesticide are not applicable to the "Measures".

Chemical substances that have been listed in IECSC and implemented environmental management for new uses, and chemical substances used for industrial purposes other than permitted uses need to be registered;

Products such as medicines (including APIs), pesticides (including pesticide prodrugs), veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers that are changed to other industrial uses, and the raw materials or intermediates used to produce the above products need to be registered If they are new chemical substances.

 

Applicant

The applicant is the subject of the environmental management registration of new chemical substances and the holder of the registration certificate. The agent no longer serves as the holder of the registration certificate.

If products such as medicines, pesticides, veterinary drugs, cosmetics, foods, food additives, feeds, feed additives, fertilizers, etc. as stipulated in Article 2 of the “Measures” are new chemical substances and are intended to be changed to other industrial uses, then producers, importers or the processing user of relevant products can be the applicants.

For chemical substances that have been included in the "List" and are subject to environmental management for new uses, and are intended to be used for other industrial purposes than permitted uses, the producers, importers or processing users of the relevant chemical substances can be the applicants.

 

Registration types

Regular registration: annual volume of production or import is ≥ 10 tons.

Simplified registration: annual volume of production or import is ≥ 1 tons & ≤10 tons.

Record registration: meet one of the following conditions

The annual volume of production or import of new chemical substances is less than 1 ton;

The new chemical substance monomer or reactant content does not exceed 2% of the polymer or belongs to the low concern polymer.

 

Requirements of application materials

Registration types	Data requirements
Regular registration	Regular registration application form; Attachments to the application form (including: legal person certificate or business license, agency contract or agreement, authorization letter; testing report or data; environmental risk assessment report; socio-economic benefit analysis report (belonging to high-hazard new chemical substances); information protection necessity explanatory materials; commitment letter of implementation or transmission of environmental risk control measures and environmental management requirements; other information on mastered environmental and health hazard characteristics, and environmental risks, etc.)
Simplified registration	Simplified registration application form; Attachments to the simplified registration application form (including: legal person certificate or business license, agency contract or agreement, authorization letter; testing reports or materials; conclusions and basis for the determination of persistence, bioaccumulation and toxicity of the registered substance; commitment letter of implementation or transmission of environmental risk control measures and environmental management requirements; other information on mastered environmental and health hazard characteristics, and environmental risks, etc.)
Record registration	Record form; Attachments to the record form (including: legal person certificate or business license, agency contract or agreement, authorization letter; for record registration of polymer, certification materials that meet the corresponding cases should be submitted; commitment letter of implementation or transmission of environmental risk control measures and environmental management requirements; other information on mastered environmental and health hazard characteristics, and environmental risks, etc.)

 

Circumstances where the technical review is not passed

	Regular registration	Simplified registration
Common terms	1. Concealment or fraud in the registration application process; 2. The name or identification information is incorrect; 3. The test report or data does not meet the requirements or the quality is poor; 4. Failure to supplement and submit relevant test reports or materials within 6 months.
Different terms	1. The content of the environmental risk assessment report has major defects or omissions, etc., which are insufficient to make a comprehensive assessment of the environmental risks of new chemical substances; 2. The environmental risk assessment shows unreasonable environmental risks or inappropriate environmental risk control measures; 3. Failing to meet the necessary requirements for application activities for highly hazardous chemical substances.	1. The registered substance has persistence, bioaccumulation and toxicity at same time; 2. There are cumulative environmental risks.

 

Testing agency qualification

Region	Testing items	Qualification requirements
Domestic	Basic requirements	Obtain the qualification certification of inspection and testing institutions in accordance with the law
	Ecotoxicology	Comply with Good Laboratory Practice (GLP) and the relevant requirements of the Ministry of Ecology and Environment for the management of chemical testing institutions
	Toxicology	An organization that has passed the GLP certification and management of the State Food and Drug Administration, a chemical toxicity identification organization that has passed the quality assessment of the Chinese Center for Disease Control and Prevention, a pesticide registration test unit announced by the Ministry of Agriculture and Rural Affairs, and an organization that has passed the Good Laboratory Practice (GLP) evaluation approved by the China National Certification and Accreditation Administration
Overseas	Physical Chemistry	ISO 17025 standard accreditation or Good Laboratory Practice (GLP)
	Toxicology/Ecotoxicology	Internationally accepted Good Laboratory Practice (GLP)

 

Data requirements

Regular and simplified registrations should submit at least the corresponding minimum required data according to the registration types. Those cases with persistent (P) and bioaccumulation (B) related characteristics should also submit special requirements data according to the registration types.

Regular registration:

The minimum required data includes basic data on physical and chemical properties, toxicology and ecotoxicology.

For P or B substances, further data on special requirements for toxicology and ecotoxicology should be submitted.

Simplified registration:

The minimum required data include basic data on physical and chemical properties, persistence, bioaccumulation and acute toxicity in the aquatic environment.

Persistent together with bioaccumulative (PB) substances should be further special data on chronic toxicity in the aquatic environment should be submitted.

For specific requirements, please refer to the "Guidance".

Physical and chemical data requirements

Compared with MEP Order No. 7, the data requirements related to the classification of physical hazards, such as oxidation, flammability, explosiveness, flash point, and auto-ignition temperature, have been reduced. Under 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.

Toxicology data requirements

No need to submit toxicology data for simplified registration.

For regular registration, non-P/B substances are required to submit the minimum required data, and the data requirements are similar to the level 2 of regular registration under current MEP order No. 7. For P or B substances, the data requirements are higher, and the data requirements are close to the level 4 of regular registration under current MEP Order No. 7.

Mutagenicity test: The data requirements are clearer, but in the three basic tests, in vivo chromosome damage data has been added.

Toxicokinetics: If there is no health hazard effect, it is no need to submit toxicokinetic test data or information; PBT and vPvB substances (with health hazard effects, excluding local toxicity) should submit a comprehensive toxicokinetic test report

Ecotoxicology data requirements

Simplified registration: the general substances need to submit three acute aquatic, degradability and bioaccumulation. For PB substances, aquatic chronic toxicity data is also required.

Regular registration: For general substances, the data requirements are similar to the level 2 of regular registration under current MEP Order No. 7. For P or B substances, the data requirements are close to the level 4 of regular registration under current MEP Order No. 7, and the data requirements for chronic toxicity of benthic organisms are added.

The test items that need to be completed with Chinese test substances have been adjusted, including acute fish toxicity and chronic fish toxicity, activated sludge respiratory inhibition toxicity test, aquatic bioaccumulation test, and biodegradability.

 

Highly hazardous chemicals

The "Guidance" clearly gives the definition and criteria for highly hazardous chemical substances.

Definition: Highly hazardous chemical substances refer to chemical substances that have persistence, bioaccumulation and toxicity at the same time, chemical substances that have high persistence and high bioaccumulation, or other chemical substances with the same environmental or health hazards.

Judgment criteria and screening methods for PBT and vPvB substances

Where the existing data is not sufficient to support the judgment criteria, the screening criteria are specified in conjunction with the requirements of registration application data, that is, 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 submit additional data.

Judgment of highly hazardous chemical substances with the same environmental or health hazards: including but not limited to endocrine disrupt chemicals (EDCs), extremely toxic (acute or chronic) substances.

 

Environmental risk assessment report

The 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 if the applied substance has no hazard classification of ecological environment and human health, and does not have persistence and bioaccumulation, at the same time, if the applied amount is less than 100 tons, then subsequent environmental risk assessment is not required.

For new chemical substances belonging to PBT and vPvB, usually the identification of discharge and exposure characteristics is the key work, that is, to identify the release of PBT and vPvB chemical substances to the environment during the entire life cycle, and all possible exposure pathways of the chemical substances to the human body and the environment. Based on the above, measures to reduce emissions and exposure to humans and the environment are proposed.

 

Social Economic Benefit Analysis Report

For highly hazardous chemical substances, a social and economic benefit analysis report needs to be submitted. 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, and analyze and evaluate the impact comparison of the two scenarios from the environmental, health, economic, and social aspects, and fully demonstrate the necessity of application activity. The chemical substances in use under the application for use shall cover all the chemical substances currently in use under the application in China.

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. 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 are equal or obvious advantages.

The impact of chemical substance activities involves the whole life cycle such as production, preparation, industrial use, consumer use and waste disposal.

Quantify and monetize related impacts as much as possible, for impacts that cannot be quantified, the expected severity and degree of impacts can be qualitatively described.

 

Information protection

When applicants need information protection, they shall submit materials explaining the necessity of applying for protection of trade secret information. The description of the necessity of information protection should list the specific information columns for which protection is applied for, and explain one by one according to the 12 conditions (see the "Guidance" for details).

The validity period of identification information such as chemical substance names shall not exceed five years from the date of first registration or record.

For chemical substances that do not have environmental hazard and health hazard classification, and whose identification information such as the name of the chemical substance has been approved for protection, can apply for an extension of the protection of identification information such as the name of the chemical substance, and the extension period shall not exceed five years.

New chemical substances obtained under the current “Measures”(MEP Order No. 7) environmental management registration certificate are also applicable.

 

Special regulations for polymers

Polymers that meet one of the following cases should go through regular registration or simplified registration, but not record registration.

1. Cationic polymers or may be expected to become cationic polymers in natural water environments.

2. Degradable or unstable polymers, including polymers that are easily degraded, decomposed, and depolymerized, and polymers that decompose after production or use.

3. A water-absorbent polymer with a number average molecular weight greater than or equal to 10,000 Daltons.

4. Polymers containing perfluoroalkyl groups covalently bonded to carbon or sulfur atoms, such as polymers containing perfluoroalkylsulfonic acid groups, perfluoroalkylcarboxylic acid groups, fluorotelomers, etc.

5. In addition to impurities, those containing elements other than the permitted elements

 

Activity report after registration

First activity report: Registration certificate holder or agent, 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 requirements for submitting an annual report are specified on the regular registration certificate, the holder of the registration certificate or its designated agent shall submit an annual report on new chemical substances before April 30 each year from the year following the date of registration.

 

Listing in IECSC

Chemical substances that have been produced, sold, processed, used, or imported in China before October 15, 2003, can apply for listing in the IECSC through the online registration system.

For new chemical substances that have obtained regular registration certificates already for 5 years since the date of their first registration, MEE will announce that they could be listed in IECSC.

New chemical substances that have obtained regular registration certificates under the “Measures” (MEP Order No. 7): As of January 1, 2021, there have been actual production or import of new chemical substances but less than five years, If five years have passed since the date of the first production or import activity, the MEE will announce that they will be listed in the IECSC. As of January 1, 2021, if there is no actual production or import of new chemical substances, MEE will announce that they will be listed in IECSC after five years from the date of implementation of the “Measures”.

New chemical substances that have obtained regular registration certificates under the “Measures” (MEP Order No. 17) without listed in IECSC, within six months from the date of implementation of the "Measures" (MEE Order No. 12), MEE will announce that they will be listed in IECSC.

 

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