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Determination and registration requirements for persistence, bioaccumulation and toxicity of new chemical substances
Release time:
2021-01-04 09:45
The Measures for the Registration of Environmental Management of New Chemical Substances (hereinafter referred to as the Measures) clarify the focus of control, with particular attention to new chemical substances with persistent (P), bioaccumulative (B), toxic (T) and equivalent environmental and health hazard characteristics. When carrying out regular and simple registration, it is necessary to judge the relevant attributes. For substances with P, B and T attributes, there are higher requirements for data submission and registration management. Today, we will learn about the judgment process and specific registration and management requirements.
Determination of 1. P, B and T attributes
The "New Chemical Substance Environmental Management Registration Guide" refers to relevant domestic and foreign standards and technical specifications, and clarifies the judgment standards for P, B, T and equivalent environmental or health hazardous chemical substances.
1. Persistence (P) and high persistence (vP) criteria
Judgment premise | Judgment criteria | Judgment result |
have half-life data | Substances are persistent in any of the following: a) The half-life in seawater is longer than 60d; B) The half-life in fresh water or river water is longer than 40d; c) The half-life in marine sediments is longer than 180d; d) The half-life in freshwater or river sediments is longer than 120d; e) The half-life in soil is longer than 120d. | P |
Substances that are highly persistent and conform to any of the following: a) The half-life in seawater, fresh water or river water is longer than 60d; B) The half-life in seawater, freshwater or river sediments is longer than 180d; c) The half-life in soil is longer than 180d. | vP | |
No half-life data a) | Rapid biodegradation test B): DOC removal rate ≥ 70% within a 10-day window of 28 days, or ThOD /ThCO2 removal rate ≥ 60% | Non-P and non-VP |
enhanced rapid biodegradation test: DOC removal rate 70% ThOD/ThCO2 removal rate 60% | ||
Intrinsic biodegradation: Zane-Whalens test: DOC reduction method, mineralization rate ≥ 70% within 7 days, logarithmic phase not more than 3 days, reduction less than 15% before degradation, no pre-acclimation inoculation | Non-P | |
Inherent biodegradation: MITI II test The mineralization rate of respimetry (oxygen consumption) is ≥ 70% within 14d, the logarithmic period is not more than 3d, and there is no pre-acclimation inoculation. |
a) This method is a screening method, which is suitable for the situation that the standard judgment cannot be made due to the lack of half-life data, and can be determined according to the basic data of regular registration or simple registration.
B) if the rapid biodegradation test result is rapid biodegradation, it can be determined that it is not persistent according to the screening standard; if the rapid biodegradation test result is not rapid biodegradation, the chemical substance can be regarded as persistent, or more screening degradation data such as enhanced rapid biodegradation test, inherent biodegradation test, hydrolysis, photolysis, etc. can be further submitted.
If any of the aforementioned test results show degradation, it can be judged not to have durability. If persistence cannot be ruled out by all of the above test results, the substance may be considered to be persistent, or further degradation simulation test data may be submitted in conjunction with the exposure route. To carry out degradation simulation test, the sediment-water environment or water environment degradation simulation test should be preferred, and the test can also be carried out in the soil phase as required. When the degradation simulation test data of any phase shows degradation, it can be judged as not having persistence, otherwise it should be judged as having persistence or high persistence.
2. Criteria for bioaccumulation (B) and high bioaccumulation (vB)
Judgment premise | Judgment criteria | Judgment result |
with bioconcentration factor (BCF) data a) | BCF＞5000 | vB |
BCF＞2000 | B | |
No bioconcentration factor (BCF) data B) | logKow≤ 4.5 | Non-B and non-vB |
logKow>4.5 | May have B |
a) Bioaccumulation is assessed primarily on the basis of bioaccumulation test data for aquatic organisms, and data for both freshwater and marine species can be used.
B) If the method is a screening method and meets the exemption conditions for bioaccumulation test, the bioaccumulation can be determined by comparing the log Kow test results with the screening criteria. For those judged as likely to be bioaccumulative according to the screening criteria, they can be regarded as bioaccumulative, or more bioaccumulative test data can be submitted for further judgment.
3. Toxicity determination standard
Toxic effect | Judgment criteria | Judgment result | |
Health Toxicity a) | Toxic if any of the following: a) The substance is classified as carcinogenic (Class 1A or 1B); B) Substance classified as germ cell mutagenicity (category 1A or 1B); c) The substance is classified as reproductive toxicity (category 1A,1B or 2); d) Other evidence of chronic toxicity, classified as specific target organ toxicity (repeated exposure) Category 1 or Category 2. | T | |
Eco-toxicity | No chronic toxicity data B) | EC50 or LC50< 0.01 mg/L for aquatic acute toxicity (algae, daphnia, fish) | T |
EC50 or LC50< 0.1 mg/L for aquatic acute toxicity (algae, daphnia, fish) | May have T | ||
Aquatic chronic toxicity data available | NOEC or EC10 for marine or freshwater organisms <0.01mg/L | T | |
a) Classify the health hazards of new chemical substances in accordance with the Code for Classification and Labelling of Chemicals (GB 30000 Series), and determine them according to the classification results.
B) This method is a screening method, and in the case of lack of aquatic chronic toxicity data for simple registration, the results of aquatic acute toxicity test data can be used to determine using screening criteria. If the application substance is determined to be potentially toxic based on the screening criteria, the substance may be considered toxic, or further aquatic chronic toxicity data may be provided to identify toxicity.
4, with the same environmental or health hazards of high-risk chemical substances to determine the standard
Highly hazardous chemicals are chemicals with both PBT and vPvB properties, or other chemicals with equivalent environmental or health hazards. Highly hazardous chemicals with equivalent environmental or health hazards include, but are not limited to, endocrine disruptors (EDCs) and extremely toxic (acute or chronic) substances.
EDCs can be compared with the existing international regulatory list, as well as in the existing international database to search whether the application substances are EDCs or suspected EDCs. If the application substance belongs to suspected EDCs, a comprehensive literature evaluation report shall be provided on the basis of retrieval or further test data required by the internationally accepted technical guidelines to conduct a preliminary evaluation of the EDCs properties of the application substance.
Very high toxicity (acute or chronic)
Toxic effect | Judgment criteria | Judgment result | |
Health Toxicity a) | Meet any of the following, with high toxicity: Acute toxicity (Category 1); Carcinogenicity (category 1A or 1B); Germ cell mutagenicity (category 1A or 1B); Reproductive toxicity (category 1A or 1B); Repeated exposure to specific target organ toxicity (category 1); | Very high toxicity | |
Eco-toxicity | Aquatic chronic toxicity data available | NOEC or EC10 for marine or freshwater organisms <0.01mg/L | Very high toxicity |
No chronic toxicity data B) | EC50 or LC50< 0.1 mg/L for aquatic acute toxicity (algae, daphnia, fish) | Considered extremely toxic | |
B) In the absence of aquatic chronic toxicity data, the results of aquatic acute toxicity test can be used for judgment.
2. registration requirements for substances P, B and T
For regular registration and simple registration, the minimum required data includes basic data and special requirements data. Among them, all new chemical substances are required to submit basic data, with P, B related characteristics should also be submitted according to the registration type of special requirements data. If it is known that the analogs of the application substance have P and B attributes, which are harmful to the environment or health, or may exist in the environment for a long time and may cause greater risks to the environment and health, the analog information shall be submitted together.
1. regular registration:
Information Requirements
For regular registration of new chemical substances, in addition to the minimum required data, new chemical substances with persistence or bioaccumulation should also submit further health toxicology and ecotoxicology special requirements data.
When registering a regular, it is necessary to carry out high-hazard discrimination of new chemical substances based on all known information such as minimum required data, put forward a clear judgment conclusion, and submit a complete analysis description. If the substance is determined to be a new hazardous chemical substance, a socio-economic benefit analysis report shall be submitted.
Review and Approval
During the review, experts will evaluate the necessity of application activities for high-hazard chemical substances and determine whether the declaration activities are necessary. If the requirements for the necessity of application activities for high-hazard chemical substances are not met, registration will not be granted.
For high-hazard chemical substances and new chemical substances with PB, PT or BT attributes, after registration, it may be proposed to limit the emission or emission concentration of new chemical substances, and implement environmental management requirements such as new use environmental management and annual report submission when they are included in the List of Existing Chemical Substances in China.
2. Simple registration:
Information Requirements
For new chemical substances for simple registration, in addition to the minimum required data, the new chemical substances with PB attribute shall further submit the special requirements data for chronic toxicity in aquatic environment. When submitting the information, it is necessary to judge the PBT attribute of the application substance according to the requirements of the guidelines, and give a clear conclusion and basis.
Simple registration review and approval
During the review, experts will evaluate the P, B, T attributes and cumulative environmental risks, and register the PBT attributes and cumulative environmental risks that are not found at the same time.
Post-registration management of 3. P, B, T substances
1. Management within the validity period of the registration certificate
Highly hazardous chemical substances and new chemical substances with PB, PT or BT attributes are required to comply with the environmental management requirements recorded in the registration certificate, including submitting annual reports, limiting the amount or concentration of new chemical substances, and one or more of other environmental management requirements.
2. Management after being listed in the List of Existing Chemical Substances in China
New chemical substances with PB, PT or BT attributes shall be indicated for their permitted uses when they are listed in the List of Existing Chemical Substances in China. For highly hazardous chemical substances and new chemical substances with PB, PT or BT attributes, environmental management requirements other than annual reports are stipulated when they are included in the "China Existing Chemical Substances List. After entering the List of Existing Chemical Substances in China, the Measures continue to manage the corresponding substances.
Chemical substances with PB, PT or BT properties that are intended to be used for other industrial purposes than the permitted use shall apply for environmental management registration for new uses before production, import or processing. For highly hazardous chemical substances, if the holder of the registration certificate changes its use, or if someone other than the holder of the registration certificate uses it for industrial purposes, it shall apply for environmental management registration for new uses before production, import or processing.
After the approval of the application for environmental management registration for new uses, if it does not belong to a highly hazardous chemical substance, the registered permitted new uses of the chemical substance shall be added to the List of Existing Chemical Substances in China; if it belongs to a highly hazardous chemical substance, the scope of environmental management for new uses in the List of Existing Chemical Substances in China shall remain unchanged.
According to the relevant provisions of the Measures and its Guidelines, the classification of substances P, B and T is very important when making simple and regular registration of new chemical substances. It will directly determine the data required for registration and the management after registration. For some special substances, it may not even be possible to obtain a registration certificate. Therefore, the identification and identification of the attributes of substances P, B and T will become a very important link in the registration work. If you have related questions, or need to consult the new chemical registration project, welcome to contact us, thank you!
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