GB/T 41005-2021 in English

《GB/T 41005-2021消费品安全 化学危害风险评估通则》由TC508（全国消费品安全标准化技术委员会）归口，主管部门为国家标准化管理委员会。

1 Scope
This document specifies the principles, processes and basic methods for assessing the possible consumer health risks caused by chemical substances in consumer products.
This document applies to the risk assessment of the effects of chemical substances in consumer products on consumer health.
2 Normative references .
The contents of the following documents constitute essential provisions of this document through normative references in the text. Where a reference is dated, only the version corresponding to that date is applicable to this document; where a reference is not dated, the latest version (including all revision sheets) is applicable to this document.
GB/T 39011- -2020 Guidelines for the identification of consumer product safety hazards
3 Terms and definitions
SZIC
The following terms and definitions apply to this document.
3.1
consumer product
Products designed and manufactured primarily, but not exclusively, for personal use, including components, parts, accessories, instructions for use and packaging of products.
[Source: GB/T 35248- -2017, 2.2]
3.2
Hazard (source) hazard
A potential source that may lead to injury.
[Source:GB/T 28803- -2012,3.2]
3.3
chemical hazard
The inherent characteristic of a chemical substance that may cause adverse effects on the human body after exposure.
3.4
risk
The risk arising from a chemical hazard, i.e. the likelihood and severity of adverse effects on humans from exposure to a chemical substance in a consumer product in a given environment.
3.5
risk assessment
Risk assessment of chemical hazards, i.e. the process of calculating and estimating the risk to consumer health under specific conditions of exposure to chemical substances in consumer products, taking into account the intrinsic properties of the chemical substance and the characteristics of the consumer.
3.6
Hazard identification
The process of identifying, listing and describing risk elements.
Hazard characterization
Qualitative or quantitative characterization of the inherent properties of a chemical hazard that may cause potentially harmful effects.
Note: Includes dose-response assessment and accompanying uncertainties.
[Source: GB/T 22760- -2020, 2.17]
3.8
Exposure assessment
An assessment of consumer exposure to a chemical substance (and its derivatives).
[Source: GB/T 22760- 2020, 2.18]
3.9
risk characterization
A qualitative and quantitative description of the likelihood of known or potential adverse health effects of a chemical substance on consumers under certain exposure conditions and the associated uncertainties.
[Source: GB/T 22760- 2020, 2.19]
3.10
Safety limit valuesafety limit value
A limiting value for a chemical substance that incorporates both concentration and time factors.
4 Principles
4.1 Information validity
SZIC
Relevant information shall be collected extensively prior to the assessment and the assessment shall use the most reasonable and credible scientific information available, and ensure that the information is reliable, relevant. The information shall be reliable, relevant, applicable and timely.
4.2 Comprehensive assessment
The assessment should consider all possible hazards (e.g. acute and chronic risks, cancer and non-cancer risks, etc.). Assessments should be carried out using qualitative, quantitative or a combination of both, with preference given to quantitative assessment methods when appropriate data are available. In addition to considering risk for all populations, special attention should be given to susceptible and high-risk groups.
4.3 Integrated measurement
Assessments should be based on available scientific data and information, taking into account the level of scientific, economic and knowledge development.
5 Process
The assessment of chemical hazards in consumer products consists of pre-assessment preparation and information collection, hazard identification, hazard characterisation, exposure assessment and risk characterisation.
A general flow of chemical hazard risk assessment in consumer products is shown in Figure 1.
6 Specific elements and basic methods
6.1 Pre-assessment preparation and information collection
Before the assessment1 , the scope of the risk assessment should be defined, relevant information should be obtained, the practical implications of the assessment should be clarified, and the desired objectives should be defined. The information to be understood includes: sources of chemical hazards, physical and chemical properties, uses, possible exposure pathways and information related to the production, storage and use of consumer products; relevant domestic and international laws and regulations, standards, published literature, expert experience and other information.
6.2 Hazard identification
6.2.1 The purpose of hazard identification is to identify chemical substances present in products that may have adverse effects on human health, and to characterize their properties.
6.2.2 The specific process of hazard identification is carried out according to the methods specified in GB/T 39011- 2020.
6.3 Hazard characterisation
6.3.1 Overview
The purpose of hazard characterisation is to obtain safety limits for chemical substances. -There are generally two ways to do this: directly from the authoritative chemical substance toxicity database; and by deriving safety limits from chemical substance toxicity data.
6.3.2 Direct adoption of safety limits from authoritative chemical substance toxicity databases
6.3.2.1 See Appendix A for commonly used chemical substance toxicity databases.
6.3.2.2 Although there are slight differences in the way safety limits are defined in different databases, the objects characterised are almost identical. For example, the Acceptable Daily Intake (ADI), Tolerable Intake (TI), Reference Dose (RfD), Maximum Allowable Concentration (MAC), Actual Safe Dose (VSD) and Slope Factor for Carcinogenesis (SF) are all different ways of expressing safety limits.
6.3.2.3 There may be multiple safety limits for the same chemical substance for different routes of exposure and different targets of toxic effects, and the corresponding safety limits should be selected according to the nature of the chemical substance and the actual exposure scenario when assessing it.
6.3.2.4 The safety limits for the same chemical substance may vary in different databases, and it is recommended that the lower value be selected.
6.3.3 Deriving Safety Limits from Chemical Substance Toxicity Data
6.3.3.1 When the safety limit value of a chemical substance is not available in the toxicity database, the safety limit value can be derived from the toxicity data of the chemical substance. It should be noted that for non-threshold chemical substances (including genotoxic carcinogens and sex-cell mutagenic substances), the derivation of safety limits from toxicity data requires highly specialized toxicological knowledge and special data analysis tools, which are not covered in this document.
6.3.3.2 The selection of toxicity data should focus on sub-chronic toxicity and chronic toxicity, and no observed adverse effect dose levels (NOAEL) or lowest observed adverse effect dose levels (LOAEL) should be collected and used whenever possible.
6.3.3.3 Specific methods for deriving safety limits from chemical substance toxicity data are described in Appendix B.
6.4 Exposure assessment
6.4.1 Overview
The purpose of an exposure assessment is to obtain the amount of chemical substances in consumer products that enter the body of the consumer during use, i.e. the exposure. The exposure assessment should focus on the route of exposure, the duration of exposure, the human characteristics of the consumer and the characteristics of the use behavior.
6.4.2 Routes of Exposure
The route of exposure refers to the way in which a chemical substance is transported and exposed to the human body, including percutaneous, inhalation, oral, subcutaneous and vascular puncture, and mucosal contact. The percutaneous, inhalation and oral routes are the most common routes of exposure to chemical substances in consumer products.
6.4.3 Selection of Exposure Assessment Methods
6.4.3.1 Specific methods for conducting exposure assessments include direct measurement, exposure modelling and biomonitoring methods, which are described in Appendix C.
6.4.3.2 The exposure modelling approach is recommended in this document and is the most feasible and cost effective method for conducting routine risk assessments and for general assessors.
6.4.4 Application of the Exposure Model
6.4.4.1 An exposure model is a mathematical model used to quantify exposure scenarios and exposure processes. Commonly used exposure models are listed in Appendix D.
6.4.4.2 The reliability of exposure assessment results depends on the soundness of the model selection and the quality of the data on the model parameters.
6.4.4.3 The difficulty in using exposure models for exposure assessment is that it is sometimes difficult to obtain sufficiently accurate data for some of the parameters in the model. In this case, the determination can generally be based on the "least favourable" principle.
6.4.4.4 When conducting an exposure assessment, all possible exposure pathways need to be considered and then the different exposure pathways should be assessed and combined to obtain a total exposure.
6.5 Risk characterisation
6.5.1 Overview
The purpose of risk characterisation is to determine whether a risk exists and to provide a qualitative and quantitative description of the level of risk. There are two general approaches: risk characterisation for non-carcinogenicity and risk characterisation for carcinogenicity. For some chemical substances that are both non-carcinogenic and carcinogenic, both the non-carcinogenic and carcinogenic risks of the chemical substance need to be considered and the corresponding risk characterisation results given.
6.5.2 Non-carcinogenic risk characterisation

1 Scope
2 Normative references
3 Terms and definitions
4 Principles
5 Process
6 Specific elements and basic methods