1 Scope
This document provides guidance on the process and methods for hazard characterisation and exposure assessment for chemical safety of consumer products.
This document applies to hazard characterisation and exposure assessment for chemical safety of consumer products.
2 Normative references
The contents of the following documents constitute essential provisions of this document by means of normative references in the text. Where the reference is to issue 8, only the version corresponding to that issue applies to this document; where the reference is not to issue 8, the latest version (including all amendment sheets) applies to this document.
GB/T 39011- -2020 Guidelines for the identification of consumer product safety hazards
3 Terminology and definitions
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
chemical hazard
The inherent characteristic of a chemical substance in a consumer product that may cause adverse effects on humans after exposure.
3.3 hazard identification
hazard identification
The process of identifying, listing and describing risk elements.
[Source: GB/T 28803- 2012, 3.7]
3.4
hazard characterizationhazard characterization
A qualitative or, if feasible, quantitative description of the inherent characteristics of a chemical substance that may cause potentially harmful effects.
Note: Hazard characterization includes dose-response assessment and the accompanying uncertainties.
[Source: GB/T 22760- -2020, 2.17]
3.5
Exposure assessment
An assessment of consumer exposure to a chemical substance (and its derivatives).
[Source: GB/T 22760- 2020, 2.18]
3.6
dose-response assessment dosefft relationship evaluation
An estimate of the relationship between the dose or exposure level of a substance and the occurrence and severity of effects.
3.7
inhalation exposure
The exposure of a hazardous substance or contaminant in a consumer product to air, which enters the respiratory tract (mouth and nose) and comes into contact with the human body.
Note: Generally expressed as the concentration of the target substance in the human respiratory environment.
3.8
Skin exposure
The form of exposure in which a hazardous substance or contaminant in a consumer product is absorbed by the body through contact with the human skin.
Note: Generally expressed as external human dose (mass of the target substance per unit of skin surface area).
3.9
Oral exposure
The form of exposure in which a hazardous substance or contaminant in a consumer product is ingested through oral contact.
Note: Generally expressed as external human dose (average daily mass of target substance per kg body weight).
3.10
Exposure scene
The relevant sources used to assess and quantify exposure in a defined situation. A set of conditions or assumptions about the route of exposure, the quantity or concentration of a chemical involved, and the organism, system or population exposed.
3.11
safety limit value
A limiting value for a chemical substance that incorporates both concentration and time factors.
4 Principles
4.1 The analysis and assessment of chemical hazard exposure for consumer product safety is carried out in a scientific and reasonable manner, taking into account the level of economic, scientific and technological development and knowledge.
4.2 To ensure that information is collected extensively before and during the work, and to ensure that the information is true, reliable and timely.
4.3 Exposure groups are considered in addition to occupational exposures, consumers or indirect exposures through the environment, as well as sensitive groups such as pregnant women, children or the elderly.
5 Process
A five-step process is required for the characterisation of chemical hazards and exposure assessment for consumer product safety, and the general process is shown in Figure 1.
6 Specific elements and basic methods
6.1 Pre-assessment preparation and information gathering
Before the assessment, the scope of the risk assessment is determined, relevant information is obtained, the practical implications of the assessment are clarified, and the desired objectives are 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, documents, published literature, expert experience and other information.
6.2 Hazard identification
6.2.1 The purpose of hazard identification is to identify and characterize chemical substances present in consumer products that may have adverse effects on human health.
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 Direct adoption of safety limits from authoritative chemical substance toxicity databases
6.3.1.1 Commonly used chemical substance toxicity databases are listed in Appendix A.
6.3.1.2 Although there are slight differences in the way safety limits are defined in the different databases, the object of characterisation is almost identical. For example, the Acceptable Daily Intake (ADI), the Tolerable Intake (TI), the Reference Intake Dose (RID). Reference concentration (RIC), minimum risk level (MRL), maximum allowable concentration (MAC). Permissible daily exposure (PDE), actual safe dose (VSD), risk specific dose (RSD) and carcinogenic slope factor (SF) are all different ways of expressing the safety limits.
6.3.1.3 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 limit should be selected according to the nature of the chemical substance and the actual exposure scenario.
6.3.1.4 The safety limits for the same chemical substance may vary in different databases, and it is recommended that the lower value be selected.
6.3.2 Derivation of safety limits from chemical substance toxicity data
If it is not possible to obtain safety limits for chemical hazards from toxicity databases, safety limits can be derived by obtaining no visible adverse effect levels (NOAELs) and lowest visible adverse effect levels (LOAELs) for chemical hazards in reliable toxicological or epidemiological studies. The NOAELs (or LOAELs) obtained from toxicological or epidemiological studies are inevitably subject to uncertainty due to intra-species differences between subjects, inter-species differences between humans and experimental animals and differences in exposure times, which can be expressed as an uncertainty factor (UF). The derivation of the safety limit Rf is given by:
6.4 Exposure assessment
6.4.1 Exposure pathways
6.4.1.1 Inhalation exposure pathways
The main routes of inhalation exposure include inhalation of chemical hazards in air and particulate matter in the breathing area, which enter the respiratory system through breathing (e.g. formaldehyde in air).
6.4.1.2 Dermal exposure pathways
The main routes of dermal exposure are the deposition of particles or aerosols containing chemical hazards on the skin, or chemical hazards that may remain on the skin after the use of consumer products (e.g. residues on clothes after dry cleaning).
6.4.1.3 Oral routes of exposure
The main modes of oral exposure include: oral exposure through sucking, chewing or licking the packaging of consumer products; oral exposure through the hand-to-mouth behaviour of children; and oral exposure from incidental exposure to some chemical hazards such as oral cleaners, glues, monomer residues, plastic softeners and PVC products.
6.4.1.4 Other routes of exposure
In addition to the main routes of exposure mentioned in 6.4.1.1 to 6.4.1.3, other routes of exposure should be considered in special cases, such as ocular splash exposure or, in a few cases, intracortical (e.g. wearing earrings or piercing) and intravascular exposure.
6.4.2 Exposure scenario construction
6.4.2.1 Representation of the use of the target chemical hazards in consumer products
The chemical hazards may be present in different consumer products and the use of the target chemical hazards in consumer products is indicated. If the analysis of the results of use or the manner of use indicates that there is no actual exposure to the target chemical hazard, this should be stated in the exposure assessment report.
6.4.2.2 Compilation of information on the use of consumer products
The compilation of information on the use of consumer products focuses on direct human exposure to the target chemical hazards in consumer products and includes information on the properties and levels of the target chemical hazards, as well as the principles of safe use of the consumer product.
6.4.2.3 Exposure scenario construction
6.4.2.3.1 Construction of inhalation exposure scenarios
The construction of an inhalation exposure scenario should include the relevant exposure scenario conditions, including the amount of consumer product used. The time of exposure, the place of exposure, and the fact that the exposed substance may be present at different times and in different forms (e.g. aerosols). Factors affecting respiratory rate such as the consumer's weight and age should also be considered.
6.4.3 Selection of exposure assessment methods
The main methods of exposure assessment are direct measurement methods. Exposure modelling methods and biomonitoring methods. The exposure modelling method is the most feasible and cost-effective method for conducting routine risk assessments and for general assessors.
6.4.4 Application of exposure models
6.4.4.1 An exposure model is a mathematical model used to quantify exposure scenarios and exposure processes. Exposure models are selected in accordance with Appendix B.
6.4.4.2 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, assumptions can generally be made based on the "least favourable" principle.
6.4.5 Uncertainty analysis
Uncertainty analysis refers to the identification of the main sources of uncertainty in the exposure assessment process and the objective description of the data, methods and limitations of the models used. The limitations of the model are objectively described and the associated uncertainties are quantified where possible.
6.5 Hazard characterisation and exposure assessment reports
An example of an exposure assessment report for a chemical hazard in consumer products is given in Appendix C. The main elements are:
a) Subject of assessment;
b) Hazard identification;
c) Hazard characterisation;
d) Exposure assessment;
e) Uncertainty analysis;
f) References.
An example exposure assessment for 2,4-dichlorophenol in wooden toys is presented in Appendix C.
1 Scope
2 Normative references
3 Terminology and definitions
4 Principles
5 Process
6 Specific elements and basic methods
1 Scope
This document provides guidance on the process and methods for hazard characterisation and exposure assessment for chemical safety of consumer products.
This document applies to hazard characterisation and exposure assessment for chemical safety of consumer products.
2 Normative references
The contents of the following documents constitute essential provisions of this document by means of normative references in the text. Where the reference is to issue 8, only the version corresponding to that issue applies to this document; where the reference is not to issue 8, the latest version (including all amendment sheets) applies to this document.
GB/T 39011- -2020 Guidelines for the identification of consumer product safety hazards
3 Terminology and definitions
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
chemical hazard
The inherent characteristic of a chemical substance in a consumer product that may cause adverse effects on humans after exposure.
3.3 hazard identification
hazard identification
The process of identifying, listing and describing risk elements.
[Source: GB/T 28803- 2012, 3.7]
3.4
hazard characterizationhazard characterization
A qualitative or, if feasible, quantitative description of the inherent characteristics of a chemical substance that may cause potentially harmful effects.
Note: Hazard characterization includes dose-response assessment and the accompanying uncertainties.
[Source: GB/T 22760- -2020, 2.17]
3.5
Exposure assessment
An assessment of consumer exposure to a chemical substance (and its derivatives).
[Source: GB/T 22760- 2020, 2.18]
3.6
dose-response assessment dosefft relationship evaluation
An estimate of the relationship between the dose or exposure level of a substance and the occurrence and severity of effects.
3.7
inhalation exposure
The exposure of a hazardous substance or contaminant in a consumer product to air, which enters the respiratory tract (mouth and nose) and comes into contact with the human body.
Note: Generally expressed as the concentration of the target substance in the human respiratory environment.
3.8
Skin exposure
The form of exposure in which a hazardous substance or contaminant in a consumer product is absorbed by the body through contact with the human skin.
Note: Generally expressed as external human dose (mass of the target substance per unit of skin surface area).
3.9
Oral exposure
The form of exposure in which a hazardous substance or contaminant in a consumer product is ingested through oral contact.
Note: Generally expressed as external human dose (average daily mass of target substance per kg body weight).
3.10
Exposure scene
The relevant sources used to assess and quantify exposure in a defined situation. A set of conditions or assumptions about the route of exposure, the quantity or concentration of a chemical involved, and the organism, system or population exposed.
3.11
safety limit value
A limiting value for a chemical substance that incorporates both concentration and time factors.
4 Principles
4.1 The analysis and assessment of chemical hazard exposure for consumer product safety is carried out in a scientific and reasonable manner, taking into account the level of economic, scientific and technological development and knowledge.
4.2 To ensure that information is collected extensively before and during the work, and to ensure that the information is true, reliable and timely.
4.3 Exposure groups are considered in addition to occupational exposures, consumers or indirect exposures through the environment, as well as sensitive groups such as pregnant women, children or the elderly.
5 Process
A five-step process is required for the characterisation of chemical hazards and exposure assessment for consumer product safety, and the general process is shown in Figure 1.
6 Specific elements and basic methods
6.1 Pre-assessment preparation and information gathering
Before the assessment, the scope of the risk assessment is determined, relevant information is obtained, the practical implications of the assessment are clarified, and the desired objectives are 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, documents, published literature, expert experience and other information.
6.2 Hazard identification
6.2.1 The purpose of hazard identification is to identify and characterize chemical substances present in consumer products that may have adverse effects on human health.
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 Direct adoption of safety limits from authoritative chemical substance toxicity databases
6.3.1.1 Commonly used chemical substance toxicity databases are listed in Appendix A.
6.3.1.2 Although there are slight differences in the way safety limits are defined in the different databases, the object of characterisation is almost identical. For example, the Acceptable Daily Intake (ADI), the Tolerable Intake (TI), the Reference Intake Dose (RID). Reference concentration (RIC), minimum risk level (MRL), maximum allowable concentration (MAC). Permissible daily exposure (PDE), actual safe dose (VSD), risk specific dose (RSD) and carcinogenic slope factor (SF) are all different ways of expressing the safety limits.
6.3.1.3 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 limit should be selected according to the nature of the chemical substance and the actual exposure scenario.
6.3.1.4 The safety limits for the same chemical substance may vary in different databases, and it is recommended that the lower value be selected.
6.3.2 Derivation of safety limits from chemical substance toxicity data
If it is not possible to obtain safety limits for chemical hazards from toxicity databases, safety limits can be derived by obtaining no visible adverse effect levels (NOAELs) and lowest visible adverse effect levels (LOAELs) for chemical hazards in reliable toxicological or epidemiological studies. The NOAELs (or LOAELs) obtained from toxicological or epidemiological studies are inevitably subject to uncertainty due to intra-species differences between subjects, inter-species differences between humans and experimental animals and differences in exposure times, which can be expressed as an uncertainty factor (UF). The derivation of the safety limit Rf is given by:
6.4 Exposure assessment
6.4.1 Exposure pathways
6.4.1.1 Inhalation exposure pathways
The main routes of inhalation exposure include inhalation of chemical hazards in air and particulate matter in the breathing area, which enter the respiratory system through breathing (e.g. formaldehyde in air).
6.4.1.2 Dermal exposure pathways
The main routes of dermal exposure are the deposition of particles or aerosols containing chemical hazards on the skin, or chemical hazards that may remain on the skin after the use of consumer products (e.g. residues on clothes after dry cleaning).
6.4.1.3 Oral routes of exposure
The main modes of oral exposure include: oral exposure through sucking, chewing or licking the packaging of consumer products; oral exposure through the hand-to-mouth behaviour of children; and oral exposure from incidental exposure to some chemical hazards such as oral cleaners, glues, monomer residues, plastic softeners and PVC products.
6.4.1.4 Other routes of exposure
In addition to the main routes of exposure mentioned in 6.4.1.1 to 6.4.1.3, other routes of exposure should be considered in special cases, such as ocular splash exposure or, in a few cases, intracortical (e.g. wearing earrings or piercing) and intravascular exposure.
6.4.2 Exposure scenario construction
6.4.2.1 Representation of the use of the target chemical hazards in consumer products
The chemical hazards may be present in different consumer products and the use of the target chemical hazards in consumer products is indicated. If the analysis of the results of use or the manner of use indicates that there is no actual exposure to the target chemical hazard, this should be stated in the exposure assessment report.
6.4.2.2 Compilation of information on the use of consumer products
The compilation of information on the use of consumer products focuses on direct human exposure to the target chemical hazards in consumer products and includes information on the properties and levels of the target chemical hazards, as well as the principles of safe use of the consumer product.
6.4.2.3 Exposure scenario construction
6.4.2.3.1 Construction of inhalation exposure scenarios
The construction of an inhalation exposure scenario should include the relevant exposure scenario conditions, including the amount of consumer product used. The time of exposure, the place of exposure, and the fact that the exposed substance may be present at different times and in different forms (e.g. aerosols). Factors affecting respiratory rate such as the consumer's weight and age should also be considered.
6.4.3 Selection of exposure assessment methods
The main methods of exposure assessment are direct measurement methods. Exposure modelling methods and biomonitoring methods. The exposure modelling method is the most feasible and cost-effective method for conducting routine risk assessments and for general assessors.
6.4.4 Application of exposure models
6.4.4.1 An exposure model is a mathematical model used to quantify exposure scenarios and exposure processes. Exposure models are selected in accordance with Appendix B.
6.4.4.2 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, assumptions can generally be made based on the "least favourable" principle.
6.4.5 Uncertainty analysis
Uncertainty analysis refers to the identification of the main sources of uncertainty in the exposure assessment process and the objective description of the data, methods and limitations of the models used. The limitations of the model are objectively described and the associated uncertainties are quantified where possible.
6.5 Hazard characterisation and exposure assessment reports
An example of an exposure assessment report for a chemical hazard in consumer products is given in Appendix C. The main elements are:
a) Subject of assessment;
b) Hazard identification;
c) Hazard characterisation;
d) Exposure assessment;
e) Uncertainty analysis;
f) References.
An example exposure assessment for 2,4-dichlorophenol in wooden toys is presented in Appendix C.
Contents of GB/T 41007-2021
1 Scope
2 Normative references
3 Terminology and definitions
4 Principles
5 Process
6 Specific elements and basic methods