GB 30000.23-2013 English PDF (GB30000.23-2013)

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GB 30000.23-2013: Rules for classification and labelling of chemical -- Part 23: Carcinogenicity
GB 30000.23-2013
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 13.300
A 80
Replacing GB 20597-2006
Rules for classification and labelling of chemicals -
Part 23. Carcinogenicity
ISSUED ON. OCTOBER 10, 2013
IMPLEMENTED ON. NOVEMBER 1, 2014
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration Committee.
Table of Contents
Foreword ... 3 
1 Scope ... 6 
2 Normative references ... 6 
3 Terms and definitions ... 6 
4 Classification criteria ... 7 
5 Decision logic and guidance ... 12 
6 Labels ... 13 
Annex A ... 16 
Annex B ... 18 
Annex C ... 19 
Annex D ... 20 
Annex E ... 23 
References ... 24 
Foreword
Chapter 4 and Chapter 6 of this Part are mandatory. The rest are
recommended.
The expected structure of "Rules for classification and labelling of chemicals"
and the national standards to be replaced are as follows.
- Part 1. General rules (replacing GB 13690-2009);
- Part 2. Explosives (replacing GB 20576-2006);
- Part 3. Flammable gases (replacing GB 20577-2006);
- Part 4. Aerosols (replacing GB 20578-2006);
- Part 5. Oxidizing gases (replacing GB 20579-2006);
- Part 6. Gases under pressure (replacing GB 20580-2006);
- Part 7. Flammable liquids (replacing GB 20581-2006);
- Part 8. Flammable solids (replacing GB 20582-2006).
- Part 9. Self-reactive substances and mixtures (replacing GB 20583-2006);
- Part 10. Pyrophoric liquids (replacing GB 20585-2006);
- Part 11. Pyrophoric solids (replacing GB 20586-2006);
- Part 12. Self-heating substances and mixtures (replacing GB 20584-2006);
- Part 13. Substances and mixtures which, in contact with water, emit
flammable gases (replacing GB 20587-2006);
- Part 14. Oxidizing liquids (replacing GB 20589-2006);
- Part 15. Oxidizing solids (replacing GB 20590-2006);
- Part 16. Organic peroxides (replacing GB 20591-2006);
- Part 17. Corrosive to metals (replacing GB 20588-2006).
- Part 18. Acute toxicity (replacing GB 20592-2006);
- Part 19. Skin corrosion/irritation (replacing GB 20593-2006);
- Part 20. Serious eye damage/eye irritation (replacing GB 20594 a 2006);
- Part 21. Respiratory or skin sensitization (replacing GB 20595-2006);
- Part 22. Germ cell mutagenicity (replacing GB 20596-2006);
- Part 23. Carcinogenicity (replacing GB 20597-2006);
- Part 24. Reproductive toxicity (replacing GB 20598-2006);
- Part 25. Specific target organ toxicity. Single exposure (replacing GB
20599-2006);
- Part 26. Specific target organ toxicity. Repeated exposure (replacing GB
20601-2006);
- Part 27. Aspiration hazard;
- Part 28. Hazardous to the aquatic environment (replacing GB
20602-2006);
- Part 29. Hazardous to the ozone layer;
- Part 30. Work safety warning signs.
This Part is Part 23 of GB 30000.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part shall replace GB 20597-2006 "Safety rules for classification,
precautionary labelling and precautionary statements of chemicals -
Carcinogenicity".
Compared with GB 20597-2006, the major technical content changes are as
follows.
- MODIFY the standard name. The Chinese name is changed to "Rules for
classification and labelling of chemicals. Part 23. Carcinogenicity". The
English name is changed to "Rules for classification and labelling of
chemicals. Part 23. Carcinogenicity";
- MODIFY the content of Chapter 1 "Scope". The "warning label" is
changed to "label". DELETE "precautionary statements";
- MODIFY the introductory phrase in Chapter 2 "Normative references";
ADD GB 13690 and GB/T 16483 as reference documents;
- ADD the introductory phrase in Chapter 3 "Terms and definitions".
- MODIFY the format of Table 2 according to GHS (fourth revised edition);
Rules for classification and labelling of chemicals -
Part 23. Carcinogenicity
1 Scope
This Part of GB 30000 specifies the terms and definitions, classification criteria,
decision logic and guidance, and labels of chemicals with carcinogenicity.
This Part is applicable to the classification and labelling of chemicals with
carcinogenicity according to "Globally Harmonized System of Classification
and Labelling of Chemicals" (hereafter referred to as GHS) of the United
Nations.
2 Normative references
The following documents are essential for the application of this document. For
dated references, only the dated editions apply to this document. For undated
references, the latest editions (including all corrections) of the referenced
documents apply to this document.
GB 13690 General rules for classification and hazard communication of
chemicals
GB/T 16483 Safety data sheet for chemical products - Content and order of
sections
United Nations “Recommendations on the transport of dangerous goods -
Model regulation” (Seventeenth revised edition)
United Nations "Globally Harmonized System of Classification and Labelling
of Chemicals" (Fourth revised edition)
3 Terms and definitions
Those defined in GB 13690 AND the following terms and definitions apply to
this document.
3.1
Carcinogen
A substance or a mixture which induces cancer or increases its incidence.
Substances and mixtures which have induced benign and malignant tumours
additional considerations, such evidence may be from either limited evidence of
carcinogenicity in human studies or from limited evidence of carcinogenicity in
animal studies.
Classification. Category 2 Carcinogen
4.2.2 Carcinogen classification is made on the basis of evidence from reliable
and acceptable methods, and is intended to be used for substances which
have an intrinsic property to produce such toxic effects. The evaluations
should be based on all existing data, peer-reviewed published studies and
additional data accepted by regulatory agencies.
4.2.3 Carcinogen classification is a one-step, criterion-based process that
involves two interrelated determinations. evaluations of strength of evidence
and consideration of all other relevant information to place substances with
human cancer potential into hazard categories.
4.2.4 Strength of evidence involves the enumeration of tumours in human and
animal studies and determination of their level of statistical significance.
Sufficient human evidence demonstrates causality between human exposure
and the development of cancer, whereas sufficient evidence in animals shows
a causal relationship between the agent and an increased incidence of
tumours. Limited evidence in humans is demonstrated by a positive
association between exposure and cancer, but a causal relationship cannot be
stated. Limited evidence in animals is provided when data suggest a
carcinogenic effect, but are less than sufficient. The terms “sufficient” and
“limited” are used here as they have been defined by the International Agency
for Research on Cancer (IARC) and are outlined in 5.1.
4.2.5 Additional considerations (weight of evidence).
4.2.5.1 The factors can be viewed as either increasing or decreasing the level
of concern for human carcinogenicity. The relative emphasis accorded to each
factor depends upon the amount and coherence of evidence bearing on each.
Generally there is a requirement for more complete information to decrease
than to increase the level of concern. Additional considerations should be used
in evaluating the tumour findings and the other factors in a case-by...