Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB/T 22760-2008 General principles for risk assessment of consumer product safety, and the following main technical changes have been made with respect to GB/T 22760-2008:
——The standard name is changed from General principles for risk assessment of consumer product safety to Consumer product safety - General principles for risk assessment;
——The terms "hazard characterization", "exposure assessment" and "risk characterization" are added (see Clause 2);
——The requirements of "throughout the consumer product life cycle" are added in the general requirements of risk assessment (see 3.3);
——The informative annex "Risk assessment processes and methods for physical hazards of consumer product safety" is added (see Annex A);
——The informative annex "Risk assessment processes and methods for chemical hazards and biological hazards of consumer product safety" is added (see Annex B);
——The informative annex "Examples of injury types of consumer product safety" is added (see Annex D);
——The informative annex "Example of risk level classification method for consumer product safety hazards" is added (see Annex E).
This standard was proposed by and is under the jurisdiction of SAC/TC 508 National Technical Committee on Consumer Product Safety of Standardization Administration of China.
The previous edition of this standard is as follows:
——GB/T 22760-2008.
Consumer product safety - General principles for risk assessment
1 Scope
This standard specifies the procedure, content and requirements of risk assessment of consumer product safety.
This standard is applicable to the risk assessment of consumer products during normal use and reasonably foreseeable misuse.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
consumer product
product designed and produced primarily for, but not limited to, personal use, including the components, parts, accessories, instructions for use, and packaging of product
[GB/T 35248-2017, Definition 2.2]
2.2
injury
damage to human health or property
Note: It is revised from Definition 3.1 in GB/T 20002.4-2015.
2.3
hazard
potential source of injury
[GB/T 28803-2012, Definition 3.2]
2.4
hazardous event
event that can cause injury
Note: It is revised from Definition 3.3 in GB/T 20002.4-2015.
2.5
hazardous situation
circumstance in which people and property are exposed to one or more hazards
Note: It is revised from Definition 3.4 in GB/T 20002.4-2015.
2.6
risk
combination of probability of occurrence and severity of injury
Note 1: The probability of occurrence includes the probability of presence of hazardous situations, occurrence of injury events and avoiding or limiting injuries.
Note 2: It is revised from Definition 3.9 in GB/T 20002.4-2015.
2.7
safety
freedom from unacceptable risk
[GB/T 20002.4-2015, Definition 3.14]
2.8
consumer product safety
state of consumer product free from unacceptable risk
[GB/T 28803-2012, Definition 3.4]
2.9
consumer product life cycle
overall process of design, production, packaging, storage and transportation, use (including maintenance) and recycling of consumer product
[GB/T 28803-2012, Definition 3.5]
2.10
intended use
use of product and/or system as per the information provided by product and/or system or, in case such information is not available, as per the mode generally understood
[GB/T 20002.4-2015, Definition 3.6]
2.11
reasonably foreseeable misuse
use of product and/or system not in the manner provided by the supplier, which is caused by the human behavior that is easily foreseeable
[GB/T 20002.4-2015, Definition 3.7]
2.12
tolerable risk
risk which is acceptable in a given context based on the current social value orientation
Note: In this standard, the terms "acceptable risk" and "tolerable risk" are considered as synonyms.
[GB/T 20002.4-2015, Definition 3.15]
2.13
risk estimation
process of assigning values to the probability of occurrence of injury and the severity of its consequences
[GB/T 28803-2012, Definition 3.13]
2.14
risk analysis
process of systematically using available information to identify hazards and estimate risks
[GB/T 20002.4-2015, Definition 3.10]
2.15
risk evaluation
process of determining whether tolerable risk has been achieved based on the result of the risk analysis
[GB/T 20002.4-2015, Definition 3.12]
2.16
risk assessment
overall process comprising risk identification, risk analysis and risk evaluation
[GB/T 23694-2013, Definition 4.4.1]
2.17
hazard characterization
qualitative or quantitative (if feasible) description of the inherent characteristics of a chemical substance that may cause potential hazard impacts
Note: Hazard characterization includes dose-response assessment and accompanying uncertainties.
2.18
exposure assessment
evaluation of consumers’ exposure to chemical substances (and their derivatives)
2.19
risk characterization
qualitative and quantitative description of the probability of known or potential adverse health effects of chemical substances on consumers under certain exposure conditions and the related uncertainties
3 General requirements of risk assessment
3.1 Information validity
Before risk assessment, relevant information shall be widely collected, and during the assessment process, relevant information shall be continuously investigated and supplemented to ensure that the information is true, reliable and timely.
3.2 Combination of qualitative and quantitative methods
Scientific and effective risk assessment methods shall be selected according to the types and characteristics of the consumer product safety hazards. When appropriate data are available, priority shall be given to the quantitative risk assessment method.
3.3 Throughout the consumer product life cycle
Different risk assessment methods shall be adopted according to the characteristics of each stage of the consumer product life cycle.
3.4 Comprehensive measurement
The level of scientific, technological, economic and knowledge development shall be taken into account comprehensively to determine the hazards, tolerable risks and risk levels. Review shall be conducted repeatedly as needed to determine the tolerable risks.
4 Procedure and content of risk assessment
4.1 Procedure
The general procedure of risk assessment includes: pre-assessment preparation, hazard identification, risk estimation, risk evaluation and other steps.
The procedure of risk assessment of consumer product safety is shown in Figure 1, based on which the risk assessment process for physical hazards, chemical hazards and biological hazards of consumer products may be refined, as given in Annexes A and B.
Note: The shaded part is the general procedure of risk assessment.
Figure 1 Flowchart for risk assessment of consumer product safety
4.2 Content
4.2.1 Pre-assessment preparation
Preparation prior to risk assessment may include:
a) Determining the service environment, service life, users, usage quantity, etc. of target consumer products.
b) Determining the tolerable risks in risk assessment of consumer product safety by comprehensively considering the influencing factors of social and economic development level according to relevant laws, regulations, standards, literature, expert experience and other information at home and abroad.
4.2.2 Hazard identification
It is a process of identifying the hazards of consumer products during normal use and reasonably foreseeable misuse. Annex C gives the types of hazards.
The ways of hazard identification mainly include:
a) Published regulations and standards;
b) Scientific and technical data (product quality and safety design requirements of various industries);
c) Accident report;
d) Consumer complaints;
e) Media;
f) Experiments and tests;
g) Expert opinions, etc.
4.2.3 Risk estimation
4.2.3.1 General
After hazard identification, the risk shall be estimated according to the hazard, with consideration of the hazardous situation, the severity of injury and the probability of occurrence of injury. See Annex A for specific methods of risk estimation and Annex D for injury types.
4.2.3.2 Content
In general, risk estimation may include the following:
a) The severity of injury. The degree of injury to human body by consumer products may generally be classified into four levels: very serious, serious, moderate and slight, as shown in Table 1. Injury scope, personal health hazards, property losses, induced secondary hazards, preventability and other aspects are generally taken as classification criteria.
Foreword II
1 Scope
2 Terms and definitions
3 General requirements of risk assessment
4 Procedure and content of risk assessment
Annex A (Informative) Risk assessment processes and methods for physical hazards of consumer product safety
Annex B (Informative) Risk assessment processes and methods for chemical hazards and biological hazards of consumer product safety
Annex C (Informative) Examples of hazard types of consumer product safety
Annex D (Informative) Examples of injury types of consumer product safety
Annex E (Informative) Example of risk level classification method for consumer product safety hazards
Bibliography
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB/T 22760-2008 General principles for risk assessment of consumer product safety, and the following main technical changes have been made with respect to GB/T 22760-2008:
——The standard name is changed from General principles for risk assessment of consumer product safety to Consumer product safety - General principles for risk assessment;
——The terms "hazard characterization", "exposure assessment" and "risk characterization" are added (see Clause 2);
——The requirements of "throughout the consumer product life cycle" are added in the general requirements of risk assessment (see 3.3);
——The informative annex "Risk assessment processes and methods for physical hazards of consumer product safety" is added (see Annex A);
——The informative annex "Risk assessment processes and methods for chemical hazards and biological hazards of consumer product safety" is added (see Annex B);
——The informative annex "Examples of injury types of consumer product safety" is added (see Annex D);
——The informative annex "Example of risk level classification method for consumer product safety hazards" is added (see Annex E).
This standard was proposed by and is under the jurisdiction of SAC/TC 508 National Technical Committee on Consumer Product Safety of Standardization Administration of China.
The previous edition of this standard is as follows:
——GB/T 22760-2008.
Consumer product safety - General principles for risk assessment
1 Scope
This standard specifies the procedure, content and requirements of risk assessment of consumer product safety.
This standard is applicable to the risk assessment of consumer products during normal use and reasonably foreseeable misuse.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
consumer product
product designed and produced primarily for, but not limited to, personal use, including the components, parts, accessories, instructions for use, and packaging of product
[GB/T 35248-2017, Definition 2.2]
2.2
injury
damage to human health or property
Note: It is revised from Definition 3.1 in GB/T 20002.4-2015.
2.3
hazard
potential source of injury
[GB/T 28803-2012, Definition 3.2]
2.4
hazardous event
event that can cause injury
Note: It is revised from Definition 3.3 in GB/T 20002.4-2015.
2.5
hazardous situation
circumstance in which people and property are exposed to one or more hazards
Note: It is revised from Definition 3.4 in GB/T 20002.4-2015.
2.6
risk
combination of probability of occurrence and severity of injury
Note 1: The probability of occurrence includes the probability of presence of hazardous situations, occurrence of injury events and avoiding or limiting injuries.
Note 2: It is revised from Definition 3.9 in GB/T 20002.4-2015.
2.7
safety
freedom from unacceptable risk
[GB/T 20002.4-2015, Definition 3.14]
2.8
consumer product safety
state of consumer product free from unacceptable risk
[GB/T 28803-2012, Definition 3.4]
2.9
consumer product life cycle
overall process of design, production, packaging, storage and transportation, use (including maintenance) and recycling of consumer product
[GB/T 28803-2012, Definition 3.5]
2.10
intended use
use of product and/or system as per the information provided by product and/or system or, in case such information is not available, as per the mode generally understood
[GB/T 20002.4-2015, Definition 3.6]
2.11
reasonably foreseeable misuse
use of product and/or system not in the manner provided by the supplier, which is caused by the human behavior that is easily foreseeable
[GB/T 20002.4-2015, Definition 3.7]
2.12
tolerable risk
risk which is acceptable in a given context based on the current social value orientation
Note: In this standard, the terms "acceptable risk" and "tolerable risk" are considered as synonyms.
[GB/T 20002.4-2015, Definition 3.15]
2.13
risk estimation
process of assigning values to the probability of occurrence of injury and the severity of its consequences
[GB/T 28803-2012, Definition 3.13]
2.14
risk analysis
process of systematically using available information to identify hazards and estimate risks
[GB/T 20002.4-2015, Definition 3.10]
2.15
risk evaluation
process of determining whether tolerable risk has been achieved based on the result of the risk analysis
[GB/T 20002.4-2015, Definition 3.12]
2.16
risk assessment
overall process comprising risk identification, risk analysis and risk evaluation
[GB/T 23694-2013, Definition 4.4.1]
2.17
hazard characterization
qualitative or quantitative (if feasible) description of the inherent characteristics of a chemical substance that may cause potential hazard impacts
Note: Hazard characterization includes dose-response assessment and accompanying uncertainties.
2.18
exposure assessment
evaluation of consumers’ exposure to chemical substances (and their derivatives)
2.19
risk characterization
qualitative and quantitative description of the probability of known or potential adverse health effects of chemical substances on consumers under certain exposure conditions and the related uncertainties
3 General requirements of risk assessment
3.1 Information validity
Before risk assessment, relevant information shall be widely collected, and during the assessment process, relevant information shall be continuously investigated and supplemented to ensure that the information is true, reliable and timely.
3.2 Combination of qualitative and quantitative methods
Scientific and effective risk assessment methods shall be selected according to the types and characteristics of the consumer product safety hazards. When appropriate data are available, priority shall be given to the quantitative risk assessment method.
3.3 Throughout the consumer product life cycle
Different risk assessment methods shall be adopted according to the characteristics of each stage of the consumer product life cycle.
3.4 Comprehensive measurement
The level of scientific, technological, economic and knowledge development shall be taken into account comprehensively to determine the hazards, tolerable risks and risk levels. Review shall be conducted repeatedly as needed to determine the tolerable risks.
4 Procedure and content of risk assessment
4.1 Procedure
The general procedure of risk assessment includes: pre-assessment preparation, hazard identification, risk estimation, risk evaluation and other steps.
The procedure of risk assessment of consumer product safety is shown in Figure 1, based on which the risk assessment process for physical hazards, chemical hazards and biological hazards of consumer products may be refined, as given in Annexes A and B.
Note: The shaded part is the general procedure of risk assessment.
Figure 1 Flowchart for risk assessment of consumer product safety
4.2 Content
4.2.1 Pre-assessment preparation
Preparation prior to risk assessment may include:
a) Determining the service environment, service life, users, usage quantity, etc. of target consumer products.
b) Determining the tolerable risks in risk assessment of consumer product safety by comprehensively considering the influencing factors of social and economic development level according to relevant laws, regulations, standards, literature, expert experience and other information at home and abroad.
4.2.2 Hazard identification
It is a process of identifying the hazards of consumer products during normal use and reasonably foreseeable misuse. Annex C gives the types of hazards.
The ways of hazard identification mainly include:
a) Published regulations and standards;
b) Scientific and technical data (product quality and safety design requirements of various industries);
c) Accident report;
d) Consumer complaints;
e) Media;
f) Experiments and tests;
g) Expert opinions, etc.
4.2.3 Risk estimation
4.2.3.1 General
After hazard identification, the risk shall be estimated according to the hazard, with consideration of the hazardous situation, the severity of injury and the probability of occurrence of injury. See Annex A for specific methods of risk estimation and Annex D for injury types.
4.2.3.2 Content
In general, risk estimation may include the following:
a) The severity of injury. The degree of injury to human body by consumer products may generally be classified into four levels: very serious, serious, moderate and slight, as shown in Table 1. Injury scope, personal health hazards, property losses, induced secondary hazards, preventability and other aspects are generally taken as classification criteria.
Contents of GB/T 22760-2020
Foreword II
1 Scope
2 Terms and definitions
3 General requirements of risk assessment
4 Procedure and content of risk assessment
Annex A (Informative) Risk assessment processes and methods for physical hazards of consumer product safety
Annex B (Informative) Risk assessment processes and methods for chemical hazards and biological hazards of consumer product safety
Annex C (Informative) Examples of hazard types of consumer product safety
Annex D (Informative) Examples of injury types of consumer product safety
Annex E (Informative) Example of risk level classification method for consumer product safety hazards
Bibliography
