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GB/T 24782-2009 (GB/T24782-2009)

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GB/T 24782-2009: PDF in English (GBT 24782-2009)
GB/T 24782-2009
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 13.300
A 80
Decision Method of Persistent, Bioaccumulative and
Toxic Substances, and Very Persistent and Very
Bioaccumulative Substances
ISSUED ON. DECEMBER 15, 2009
IMPLEMENTED ON. JULY 1, 2010
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of PRC.
3. No action is required - Full-copy of this standard will be automatically &
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Table of Contents
Foreword ... 3
Introduction ... 4
1 Application Scope ... 5
2 Terms and Definitions ... 5
3 Identification of PBT Substances ... 6
4 Identification of vPvB Substances ... 9
5 Identification of PBT or vPvB Substances Using Screening Standard ... 9
Foreword
This Standard was drafted by referring to REACH (Registration, Evaluation,
Authorization and Restriction of Chemicals) Regulation Annex XIII Criteria for the
Identification of Persistent, Bioaccumulative and Toxic Substances, and Very
Persistent and Very Bioaccumulative Substances, the REACH Regulation Guidance
Technical Guidance Document for Preparing the Chemical Safety Assessment,
Chapter R 11 Evaluation of Persistent, Bioaccumulative and Toxic Substances and
Very Persistent and Very Bioaccumulative Substances, and UN Directive 67/548/EEC
Classification, Packaging and Labelling of Dangerous Substances. The relevant
technical content is fully consistent with the above-mentioned documents. Some
editorial modifications are made in the format of the standard.
This Standard was proposed and under the jurisdiction of the National Standardization
Technical Committee on Dangerous Chemical Management (SAC/TC 251).
The drafting organization of this Standard. General Administration of Quality
Supervision Safety Research Centre of Imported and Exported Cosmetics.
The main drafters of this Standard. Sun Xin, Chen Huipeng, Wang Xiaobing, Mei Jian,
Li Xi, Zhang Jing, Li Lei.
This Standard was drafted for the first time.
Decision Method of Persistent, Bioaccumulative and
Toxic Substances, and Very Persistent and Very
Bioaccumulative Substances
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). The mass fraction of
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-
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;
......
 
(Above excerpt was released on 2017-10-22, modified on 2022-02-20, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/GBT24782-2009