SN/T 3801-2014Procedures of risk assessment for GHS labeling of consumer products (English PDF)
基于GHS标签的消费品风险评估方法
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Issued by
General Administration of Customs
Level / Type
National · Recommended
Issue date
January 1, 1970
Implementation date
January 1, 1970
Scope
SN/T 3801-2014 is the English-translated version of 基于GHS标签的消费品风险评估方法.
SN/T 3801-2014 — This standard specifies the scope of the assessment of risk based on consumer products, "the United Nations Harmonized System of Classification and Labeling" (GHS) label, the original , Procedures, content and requirements.
This standard applies to the use of consumer products, leaving consumers with a certain amount of exposure and exposure time for chronic GHS label Risk assessment of health effects.
This mainly refers to standard consumer products cleansers, deodorants, waxes, paints, adhesives, mosquito insecticides, do not pack Items include chemicals, pharmaceuticals and regulations involved substances (such as drugs, quasi-drugs, cosmetics) and agrochemicals regulations involved substance.
Note 1. here, refers to the chronic health effects of carcinogenicity, reproductive toxicity 1), or target organ toxicity based on repeated exposure, excluding acute toxicity, skin corrosion/irritation.
Note 2. The standard refers to consumers who use the product directly, by secondary exposure (exposure to consumer products direct users) do not apply to this standard.
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Document preview — SN/T 3801-2014
National Standard of the People's Republic of China
- ICS
- 03.080.30
- Classification
- A 12
Issued by: General Administration of Customs
Contents
- Foreword
- 1 Scope
- 2 Risk Assessment Principles
- 3 Risk assessment process, content and requirements
- 3.1 Risk assessment procedures
- 3.2 Based on the GHS hazard classification
- 3.3 Route of Exposure
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The content of the technical standards and the Japanese National Institute of Technology and Evaluation (NITE) is "based on the GHS label consumer products Risk Assessment Basic Program "(BasicproceduresofriskassessmentforGHSlabelingofconsumerproducts) consistent with the English version.
This standard configuration and do the following editorial changes.
--- Delete the original file in the introductory, informative chapters backgrounds and objects;
--- References descriptive text portion of GHS, as well as reference documents and other information will be described moiety;
--- Original documents related footnote references adjust this standard references;
--- The original file in Appendix 1 (now standard in Appendix A) in terms of the definition of the reference source information to the message source section;
--- Use the "standard" instead of the "Guide." this standard is proposed and managed by the National Certification and Accreditation Administration Committee.
This standard was drafted. Chinese Academy of Inspection and Quarantine, AQSIQ import and export of chemical safety institute.
1 Scope
This standard specifies the scope of the assessment of risk based on consumer products, "the United Nations Harmonized System of Classification and Labeling" (GHS) label, the original , Procedures, content and requirements.
This standard applies to the use of consumer products, leaving consumers with a certain amount of exposure and exposure time for chronic GHS label Risk assessment of health effects. This mainly refers to standard consumer products cleansers, deodorants, waxes, paints, adhesives, mosquito insecticides, do not pack Items include chemicals, pharmaceuticals and regulations involved substances (such as drugs, quasi-drugs, cosmetics) and agrochemicals regulations involved substance.
Note 1. here, refers to the chronic health effects of carcinogenicity, reproductive toxicity 1), or target organ toxicity based on repeated exposure, excluding acute toxicity, skin corrosion/irritation.
Note 2. The standard refers to consumers who use the product directly, by secondary exposure (exposure to consumer products direct users) do not apply to this standard.
2 Risk Assessment Principles
It refers to the probability of the risk of chemical exposure to adverse impact on the substance in the environment to human health or organism. risk the level depends on the inherent hazards of chemicals in the human body and the environment or biological "quantitative exposure." Consumer exposure by comparing the response data (even if long-term human exposure is expected to repeat in season invalid estimate) and exposure data (Estimate exposure to consumer products containing chemical substances) is obtained.
The risk assessment should comply with the following principles. the consumer and the estimated risk of possible exposure should be given the conservative, protective assumptions to most Maximize reduce the possibility of underestimating exposure or risk; exposure assessment or estimate should be based on data and/or conservative assumptions, risk assessment and the real Animal test data extrapolation to humans approach, by setting the uncertainty factor, aside conservative margin of safety.
3 Risk assessment process, content and requirements
3.1 Risk assessment procedures
Based on the risk assessment of chronic health hazards of chemicals to determine whether to use the GHS hazard label determination process shown in Figure 1.
3.2 Based on the GHS hazard classification
Based on a risk assessment should be carried out prior to the GHS hazard classification.
When consumer products or consumer products result in the classification of a chemical substance is any chronic health hazard (carcinogenicity, reproductive toxicity, or Specific target organ toxicity - repeated exposure), the risk assessment should be carried out.
It should be noted that even in such a case, consumer product suppliers are still not necessary to characterize the chronic health risks of the products, and make with a risk-based GHS classification create labels for their products.
3.3 Route of Exposure
The first step of the risk assessment of consumer products should identify exposure pathways.
Consumer products may route of exposure is inhalation, transdermal, oral, or a combination of the above routes of exposure. Possible exposure pathways through
1) including developmental toxicity.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 11 pages — is available in the English PDF.
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