Interpretation of Key Points of Environmental Management Registration Guide for New Chemical Substances

On November 19, the Ministry of Ecology and Environment officially issued the "Guidelines for the Registration of Environmental Management of New Chemical Substances" (hereinafter referred to as the "Guidelines"). The "Guide" is a supporting normative document for the implementation of the "New Chemical Substances Environmental Management Registration Measures" (Order No. 12 of the Ministry of Ecology and Environment, hereinafter referred to as the "Measures"), which refines the relevant provisions of the "Measures" and clarifies the specific implementation requirements. This guide mainly includes the scope of registration, registration type, registration procedures, registration application material requirements, polymer special provisions and post-registration tracking management, etc., applicants and agents can refer to the guide to register, and fulfill the relevant post-registration obligations.

We have sorted out the contents that are generally concerned by the industry and hope to learn and discuss with you.

Registration scope

Pharmaceutical raw materials, pesticide raw materials, veterinary raw materials are not applicable to registration. At the same time, it is clear that medicines (including raw materials), pesticides (including pesticide technical drugs), veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers and other products are changed to other industrial uses and belong to new chemical substances. Registration is required.

Surface treatment agents, chelating agents, flocculants, adhesion promoters and other new chemical substances produced when they are expected to achieve specific functions are not artificially produced, imported or sold, and do not need to be registered.

New use environmental management, has been listed in the "list" and the implementation of new use environmental management, used for other industrial uses other than the allowed use of chemical substances, need to be registered; if the substance is judged to be a highly hazardous substance, after entering the "list", all uses without a registration certificate need to be registered.

Applicant and Agent

Under normal circumstances, the applicant for the environmental management registration of new chemical substances shall be an enterprise or institution engaged in the production or import of new chemical substances in China, or a production or trading enterprise that intends to export new chemical substances to China. The proposed change of use to other industrial uses or new uses of environmental management substances, processing users can also be the applicant.

It is clear that the applicant is the main body for the registration of environmental management of new chemical substances. For the holder of the registration certificate, the agent needs to perform the registration of environmental management of new chemical substances and the environmental management obligations after registration with the applicant. The requirements for agents have been reduced, and registered capital is no longer a mandatory requirement for agent qualifications.

The "Guide" clearly stipulates the validity period of the agency contract, requiring that the validity period of the agency contract or agreement should cover the validity period of the responsibilities and obligations of the holder of the registration certificate, or renew it before the expiration of the validity period.

Registration type and data requirements

There are three types of registration: regular registration, simple registration and filing.

Under the conditions of regular declaration and simple declaration, there are two special forms of registration: joint registration and series registration. Among them, joint registration means that two or more applicants apply for environmental management registration of the same new chemical substance at the same time. Series registration means that the same applicant applies for registration together for multiple new chemical substances with similar molecular structures, the same or similar uses and similar test data. The number of series registered substances cannot exceed 6.

According to the existing regulations, regular registration cancels the requirement that the same data needs to be accumulated. Applicants only need to apply according to their actual situation, and there is no need to consider the increase in the requirements for declared data due to multiple applicants using the same data for registration.

Registration procedures

The registration procedures for filing are mainly divided into preparation of registration applications, submission of application materials, filing applications, compliance spot checks, and disclosure, and do not involve approval and publicity. After submitting the filing application materials, relevant activities can be carried out, and the solid management center conducts random spot checks and regular disclosure of the filing materials. After successful filing, the applicant shall pay attention to the spot check. If there is a notice of correction, relevant materials shall be supplemented as required in a timely manner.

The registration procedures of regular registration and simple registration are mainly divided into submission of application materials, formal examination and acceptance, technical review, publicity and registration decision, and disclosure of results. The time limit for technical review of simple registration and regular registration is still 30 days and 60 days respectively, and the composition of reviewers is different. Simple registration is carried out by the solid management center for technical review, while regular registration is carried out jointly by the solid management center and the review committee. Several cases of failure to pass the technical review are clearly defined:

Disapproval of technical review

After the technical review, if the applicant for regular registration and simple declaration fails to submit supplementary materials within 6 months, it will not pass the technical review. Applicants are required to pay continuous attention to the registration progress of the data during the post-evaluation correction process. If the registration is overdue, the time for approval can only be re-registered, resulting in a significant delay in obtaining approval.

When preparing for simple registration, if it is found that the application substance has PBT attribute at the same time, because it will not pass the registration review, it can be directly prepared according to the regular registration, or the activity amount can be reduced to less than 1 ton/year for filing registration.

Data Requirements

The specific data requirements for regular registration and simple registration are specified in the Guide. The data required for regular registration include basic data on physical and chemical properties, health toxicology and ecotoxicology, and further data on special requirements for health toxicology and ecotoxicology should be submitted for P and/or B substances. Additional data may be requested if the data provided are not sufficient to support the risk assessment.

The minimum data required for simple registration include physical and chemical properties and basic ecotoxicological data. For substances with both P and B properties, further specific requirements data for chronic toxicity in the aquatic environment shall be submitted. Specific data requirements are as follows:

Physical and chemical data requirements

Compared with order 7, the data requirements related to physical hazards such as oxidation, flammability and explosiveness are reduced. Under the regular registration, the data requirements for the separation constant and Henry constant are added, and the data for substances in different physical states are adjusted accordingly.

The map data of organic matter are clarified, and at least two kinds of infrared, nuclear magnetic resonance and mass spectrometry are provided.

Health Toxicology Data Requirements

Easy registration: no need to submit health toxicology data.

regular registration: Basic data are required for regular registered substance, including acute toxicity (oral, transdermal, inhalation), skin corrosion/irritation, eye irritation, skin sensitization, mutagenicity, recurrent exposure and reproductive/developmental toxicity data. On the basis of basic data requirements, P/B substances are required to submit carcinogenicity assessment reports. The data requirements for PB substances are the highest, and toxicokinetic data and chronic toxicity data are also required. The toxicokinetic data are only required when the declared substance has non-local toxicity.

Ecotoxicological data requirements

Simple registration: simple registration substances are required to submit basic data, including aquatic acute data, degradation and bioaccumulation data. For class PB substances, aquatic chronic toxicity data are also required.

regular registration: on the basis of the data requirements for simple registration of class PB substances, regular registration substances shall also submit the data of activated sludge respiratory inhibition toxicity, adsorption/desorption and earthworm acute toxicity. In the seed germination and root elongation test, terrestrial plant growth test, worm propagation test, earthworm propagation test, and benthic chronic toxicity data, one of the P/B substances should be selected according to the logKow value, and three of the PB substances should be selected.

Special Notes:

The test items to be completed with Chinese test substances include fish acute and chronic toxicity, activated sludge respiratory inhibition toxicity, aquatic bioaccumulation and biodegradability tests.

Chemical substances used only as pesticide intermediates, pharmaceutical intermediates or veterinary drug intermediates, health toxicology and ecotoxicology minimum requirements data can be submitted only for basic data.

Data Quality Requirements

The basic data of the minimum requirement data shall be derived from the test report, the special data of the minimum requirement data shall be mainly derived from the test report, and the other application data shall be preferentially derived from the test report. In special cases where actual testing is not possible, the application data can also come from non-test data generated by other methods. If non-test data is submitted, the reasons, methods or data sources and bases shall be fully explained.

If testing is performed, the test sample shall be a pure substance (total impurities <20%). If the specified purity cannot be achieved, the test data can be obtained from the preparation. The test report shall indicate the purity of the sample and provide the reason why it cannot be purified. Since Order 12 requires that the test data for physical and chemical properties, health toxicology and ecotoxicology characteristics are required to come from pure substances, the health toxicology and ecotoxicology test reports previously conducted with products cannot be used in future declarations if valid proof of inability to purify cannot be provided.

Qualification Requirements for Testing Institutions

Test Method Requirements

The testing of new chemical substances completed in the territory shall be carried out in accordance with the requirements of the Guidelines for Chemical Testing. The testing of new chemical substances completed abroad shall be carried out in accordance with the principle of consistency of testing methods, and priority shall be given to the OECD Chemical Testing Guidelines or other internationally recognized testing methods.

When the Organization for Economic Cooperation and Development (OECD) chemical testing guidelines are updated and domestic chemical testing methods or national standards are not updated in a timely manner, testing recommend be carried out with reference to the latest OECD chemical testing guidelines. For special projects that do not have a normative method, exploratory research methods are allowed for testing.

For a test report issued using a test method that is not currently effective, if the test method has been revised for 5 years and the applicant believes that the test report issued based on the original test method is still valid, the applicant shall compare the old and new test methods and evaluate the reliability, relevance and scientificity of the test report.

The Guide not only stipulates the qualifications and test methods of testing institutions, but also adds provisions on the validity period of test reports. If the applicant believes that the original report issued by the updated test method for 5 years is still valid, the reliability, relevance and scientificity of the test report shall be evaluated. If it is determined that the hazard assessment requirements are not met during the review, it may be required to re-test using the revised test method.

High Hazardous Chemicals

The "Guide" clearly gives the definition and judgment standards of high-hazard chemical substances. According to the standards, there are three types of substances that will be judged as high-hazard chemical substances. When registering, a social and economic benefit analysis report needs to be submitted, and new use environmental management will be implemented after registration.

1)PBT substance

2)vPvB substance

3) Other chemicals with equivalent environmental or health hazards, including but not limited to extremely toxic and endocrine disrupting chemicals (EDCs)

Regarding the determination criteria of P, B and T, the Guide also gives the corresponding determination criteria and screening method criteria in combination with the data requirements at the time of registration. If the judgment based on the criteria of the screening method cannot be excluded from PBT attribute, it can be regarded as having the above characteristics, or further data can be submitted for confirmation.

Environmental Risk Assessment Report

According to the requirements of the "Guidelines", substances subject to regular declaration are required to carry out environmental risk assessment in a quantitative manner, and specific requirements such as hazard assessment, exposure assessment, environmental risk characterization and uncertainty analysis are clarified.

If the hazard assessment shows that the application substance has no classification of ecological environment and human health hazards, and is not persistent and bioaccumulative, and the application amount is less than 100 tons, no follow-up environmental risk assessment is required.

An environmental risk assessment report shall be prepared during the assessment of the series of registered substances, the identification and physical and chemical data shall not be shared, the classification shall be strict and tight, and the lowest toxicity data or the highest hazard shall be taken during the hazard assessment, and the predicted no effect concentration (PNEC) shall be derived. During the exposure assessment, the application for registration of each substance is accumulated for quantitative assessment.

Analysis report of social and economic benefits

For highly hazardous chemical substances, a socio-economic benefit analysis report is required for regular registration. 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. If the necessity of the declaration activity does not meet the requirements, it is a case where the technical review is not passed.

The new chemical substance activity is considered necessary only when the economic and social benefits of the new chemical substance activity exceed the risks to human health and the environment, and the human health and environmental impacts and economic and social benefits of the new chemical substance activity have considerable or obvious advantages compared with all chemical substances in use.

At the time of preparation, the chemical substances in use under the application shall cover all the chemical substances in use under the current domestic use. The impacts of material activities involve full life cycle stages and need to be quantified and monetized as much as possible.

Information Protection

When the regular and simplified registration applicants need to protect the identification information, they shall submit the materials explaining the necessity of applying for information protection, and the filing application does not need to submit the materials explaining the necessity of information protection.

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. Under the current regulations, new chemical substances that have obtained the environmental management registration certificate of new chemical substances and substances that have entered the "List" are also subject to the protection period, up to December 31, 2025.

If it is not a highly hazardous chemical substance or has a high potential environmental or health risk, the holder of the registration certificate may submit an application for extension of the disclosure of the identification information to the competent authority six months before the expiration of the validity period of the information protection, and provide necessary explanatory materials. If the statement is sufficient through the examination of the application for extension, the term of protection may be extended for a maximum of five years. Holders of all registration certificates of the substances to be applied for are required to apply. If more than one holder of the registration certificate fails to submit an application for extension on time, the competent department shall not extend the application.

Special provisions for polymers

If the monomer or reactant content of the new chemical substance does not exceed 2% and the low-concern polymer registration conditions are met, the registration can be handled, except for the following five situations:

² Cationic polymers or those that are expected to become cationic polymers in natural water environments.

2 Degraded or unstable polymers.

² Water-absorbent polymers with a number average molecular weight of 10,000 daltons or more.

² Fluoropolymers containing perfluoroalkyl sulfonic acid groups, perfluoroalkyl carboxylic acid groups, or fluorotelomer structural segments in the structure; and Fluoropolymers containing perfluoroalkyl structural segments covalently bonded to carbon or sulfur atoms in the polymer molecule.

Containing elements other than permitted elements, in addition to impurities.

For polymers that do not meet the filing conditions, the applicant shall apply for regular or simple registration according to the amount of registration applied. When polymers that meet the following three conditions at the same time are subject to regular or summary registration, they are exempted from submitting health toxicology, ecotoxicology data and environmental risk assessment reports.

2 the structure does not contain other metals other than sodium, magnesium, potassium, calcium;

Insoluble in water, lipophilic solvents (n-octanol, n-heptane) and general-purpose solvents (tetrahydrofuran, dimethylformamide);

Stability under acid-base conditions, I .e. stability tests at pH values of 4.0,7.0,9.0 and 1.2 (if physiologically important).

Post-registration tracking management requirements

Producers, importers and processing users of new chemical substances are required to transmit registration-related information to downstream users.

Researchers, producers, importers and processing users of new chemical substances shall conduct new hazard information and environmental risk tracking, and report to the competent department in a timely manner when new chemical substances are found to have new environmental or health hazard characteristics or environmental risks. At the same time, data preservation is required, including three years for filing materials and ten years for regular and simple registration materials.

The holder or agent of the regular registration certificate shall submit the first activity report within 60 days from the date of the first production activity or the first import and transfer to the processing user. 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.

In addition, the guidelines add that producers and processing users who regular to register new chemical substances should, in accordance with the provisions of the measures, make public the implementation of environmental risk control measures and environmental management requirements through their official websites or other ways that are easy for the public to know after the first activity, and update them in a timely manner.

Inclusion in the Directory

The method of inclusion in the List is still based on the two main categories of actual activities in the territory before the implementation of the environmental management registration system for new chemical substances and the registration certificate obtained after the implementation of the management.

1) Chemical substances that have been produced, sold, processed, used or imported in China before October 15, 2003 can be added to the "List" through the online registration system. This means that substances that have been actually active before the implementation of the new environmental management registration system for chemical substances can apply for inclusion in the List at any time if they have relevant certification materials that meet the requirements, without waiting for the list addition window to open.

2) The registered substances under the laws and regulations in different periods shall be entered into the List according to the following time:

a) New chemical substances that have obtained the regular registration certificate of Order 12 shall be included in the List five years from the date of first registration.

B) new chemical substances that have obtained the registration certificate of regular 7, if there have been actual activities before the entry into force of order 12, they shall be listed in the list for five years; If no activity has been carried out, it shall be listed in the list for five years from the date of implementation of the measures.

c) New chemical substances that have obtained the No. 17 normal declaration and registration certificate shall be included in the List within six months from the date of implementation of the Measures.