GB/T 24782-2009Decision method of persistent,bioaccumulative and toxic substances,and very persistent and very bioaccumulative substances (English PDF)
持久性、生物累积性和毒性物质及高持久性和高生物累积性物质的判定方法
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
December 15, 2009
Implementation date
July 1, 2010
Scope
GB/T 24782-2009 is the English-translated version of 持久性、生物累积性和毒性物质及高持久性和高生物累积性物质的判定方法.
GB/T 24782-2009 sets out the criteria by which a substance is identified as persistent, bioaccumulative and toxic (PBT) or as very persistent and very bioaccumulative (vPvB).
Clause 1 states that the standard specifies those identification criteria, and adds that Chapter 3 and Chapter 4 are only applicable to metallo-organic compounds.
The text runs as Application Scope, Terms and Definitions, Identification of PBT Substances, Identification of vPvB Substances and Identification of PBT or vPvB Substances Using Screening Standard, with a foreword and an introduction before them.
Clause 2 defines a PBT or vPvB substance as one that contains a persistent, bioaccumulative and toxic or very persistent and very bioaccumulative constituent at a content of 80% or more; a substance containing maximum X% (or X% to Y%) PBTs or vPvBs as one in which a single such constituent or impurity is present at 0.1% or more but below 80%; and a substance forming PBTs or vPvBs as one whose constituents or impurities degrade or transform into such substances, with any single transformation or degradation product exceeding 0.1% of the mass of the original substance.
Within clause 3 the identification works through the criteria for classification as carcinogenic, teratogenic and toxic for reproduction, each split between the substance known to have the effect and the substance deemed possibly to have it on the evidence of appropriate long-term research in animals or of other relevant information.
Clause 5 states that the existing data on many substances cannot settle their PBT or vPvB properties and that the screening standard is then used as alternative information: a substance capable of ready biodegradation is not to be considered persistent or very persistent, the Zahn-Wellens and MITI II inherent biodegradability tests exclude persistence on a mineralization rate of at least 70% within 7 days with a logarithmic phase of no more than 3 days and no cultivated inoculation, and the Biowin 2, Biowin 3 and Biowin 6 prediction models identify a substance as persistent where biodegradation is not fast and the predicted final biodegradation time runs to several months.
The foreword states that the standard was drafted by reference to Annex XIII of the REACH Regulation, to Chapter R 11 of the REACH technical guidance document for preparing the chemical safety assessment and to UN Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances, that its technical content is fully consistent with those documents apart from editorial changes of format, and that it was drafted for the first time; it is proposed by and under the jurisdiction of the National Standardization Technical Committee on Dangerous Chemical Management (SAC/TC 251).
The page carries an excerpt of the translation, so clause 4 and the middle of clauses 3 and 5 are not shown. It was issued on 15 December 2009 and has applied since 1 July 2010.
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Document preview — GB/T 24782-2009
National Standard of the People's Republic of China
- Classification
- A 80
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword3
- Introduction4
- 1 Application Scope5
- 2 Terms and Definitions5
- 3 Identification of PBT Substances6
- 4 Identification of vPvB Substances9
- 5 Identification of PBT or vPvB Substances Using Screening Standard9
1 Application Scope
This Standard specifies the criteria for the identification of persistent, bioaccumulative and toxic substances, and very persistent and very bioaccumulative substances.
Chapter 3 and Chapter 4 of this Standard are only applicable to metallo-organic compounds.
2 Terms and Definitions
For the purposes of this Standard, the following terms and definitions apply.
2.1 PBT or vPvB substance
A substance which contains a persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative constituent. And the content of the constituents is 80% or more.
2.2 Substance containing maximum X% (or X% ~ Y%) PBTs or vPvBs
A substance which contains one or more persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative constituents or impurities; and the content of a single content or impurity is greater than or equal to 0.1% (but less than 80%). The content may be a maximum content (X%) or content range (X% ~ Y%), as appropriate.
2.3 Substance forming PBTs or vPvBs
A substance whose constituents or impurities are degradable or can be transformed into persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative substances; and the content of a single transformation or degradation product formed is greater than 0.1% (of the mass of the original substance).
3 Identification of PBT Substances
There is sufficient evidence of the relationship between the exposure of human body to some substance and cancer.
3.3.2.2 The substance deemed possibly carcinogenic for human body
The is sufficient evidence of the convincing hypothesis that cancer is caused because of exposure of human body to some substance, generally based on.
a) appropriate long-term research in animals;
b) other relevant information.
3.3.3 The substance meets the criteria for classification as teratogenic
3.3.3.1 The substance known to be teratogenic
There is sufficient evidence of the relationship between the exposure of human body to some substance and the damage of genetic genes.
3.3.3.2 The substance deemed possibly teratogenic
There is sufficient evidence of the convincing hypothesis that the damage of genetic genes is caused because of exposure of human body to some substance, generally based on.
a) appropriate long-term research in animals;
b) other relevant information.
3.3.4 The substance meets the criteria for classification as toxic for reproduction
3.3.4.1 The substance known to damage human reproduction
There is sufficient evidence of the relationship between the exposure of human body to some substance and the damage of reproduction.
3.3.4.2 The substance deemed possibly toxic for the growth of human body
There is sufficient evidence of the relationship between the exposure of human body to some substance and the growth of descendants.
3.3.4.3 The substance deemed possibly damaging for the reproduction of human beings
There is sufficient evidence of the convincing evidence that the damage of reproduction is caused by the exposure of human body to some substance, based on.
a) there is obvious evidence in the animal research of reproduction damage containing no toxicity or the evidence of reproduction damage of secondary non-
5 Identification of PBT or vPvB Substances Using Screening Standard
The existing data of many substances are incapable of identifying the PBT/vPvB properties. Then the screening standard is used as alternative information to identify whether the substance fulfils the criterion of PBT/vPvB properties.
5.1 Indication of P and vP properties
5.1.1 Tests on ready biodegradation
If the substance is capable of ready biodegradation, then it shall not be considered to be a persistent or very persistent substance.
5.1.2 Tests on enhanced ready biodegradation
If the substance is capable of ready biodegradation, then it shall not be considered to be a persistent or very persistent substance.
5.1.3 Tests on inherent biodegradability
a) Zahn-Wellens test The mineralization rate within 7 d using the DOC subtraction method >= 70%, the logarithmic phase not more than 3 d, the subtraction before degradation lower than 15% and no cultivated inoculation is needed, so it shall not be considered to be a persistent substance;
b) MITI II test The mineralization rate within 7 d using the respirometric method >= 70%, the logarithmic phase not more than 3 d and no cultivated inoculation is needed, so it shall not be considered to be a persistent substance.
5.1.4 Prediction model
a) Biowin 2 (nonlinear model prediction) and Biowin 3 (final biodegradation time)
The biodegradation is not fast (the probability < 0.5)i and the final biodegradation time range prediction >= several months (the value < 2.2), and then it is identified to be a persistent substance;
b) Biowin 6 (MITI nonlinear model prediction) and Biowin 3 (final biodegradation time)
The biodegradation is not fast (the probability < 0.5)i and the final biodegradation time range prediction >= several months (the value < 2.2), and then it is identified to be a persistent substance; […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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