GB/T 41725-2022 English PDF (GBT41725-2022)

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GB/T 41725-2022: General principles for setting limits of chemical substances in consumer products
GB/T 41725-2022
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 03.120.99
CCS A 00
General principles for setting limits of chemical substances
in consumer products
ISSUED ON: OCTOBER 12, 2022
IMPLEMENTED ON: OCTOBER 12, 2022
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Basic process ... 6
5 Information collection ... 7
6 Determination of benchmark limits ... 9
7 Socio-economic analysis ... 10
8 Determination of comprehensive limits ... 12
References ... 13
General principles for setting limits of chemical substances
in consumer products
1 Scope
This document gives the basic process for setting the limits of chemical substances in
consumer products, and stipulates the collection of information, determination of
benchmark limits, socio-economic analysis, determination of comprehensive limits,
and other related content.
This document is applicable to standardize and guide various organizations to carry out
activities related to the setting of chemical substance limits in consumer products.
2 Normative references
The following documents contain the provisions which, through normative reference in
this document, constitute the essential provisions of this document. For the dated
referenced documents, only the versions with the indicated dates are applicable to this
document; for the undated referenced documents, only the latest version (including all
the amendments) is applicable to this document.
GB/T 41007-2021 Consumer product safety - Guidelines for characterization and
exposure assessment of chemical hazard
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 consumer products
The products that are designed and produced mainly (but not only) for personal use,
including product components, parts, accessories, instructions for use, and packaging.
[Source: GB/T 35248-2017, 2.2]
3.2 safety limits
For the sake of the protection of human health, the restrictive values that are stipulated
for chemical substances, which include concentration and time factors.
3.3 benchmark limits
When the chemical substance exposure is equal to the safety limit, the corresponding
content of the chemical substance in the consumer product.
3.4 comprehensive limits
Under the constraint that the content of chemical substances in consumer products is
lower than the benchmark limit, and the influencing factors such as economy, society
and environment are comprehensively considered, the content of chemical substances
in consumer products that maximizes the overall welfare of the society.
3.5 risk acceptance
A decision to accept a particular risk.
[Source: GB/T 23694-2013, 4.7.1.6]
3.6 socio-economic analysis; SEA
A method of analyzing all relevant effects (i.e., including both positive and negative
changes) of one scenario relative to another.
Note: Relevant impacts include human health, environment, economy, society, and wider economic
impacts.
[Source: GB/Z 24785-2009, 3.26, modified]
4 Basic process
4.1 Information collection
The information about the toxicities, functions, usage scenarios, and objects of use of
chemical substances, as well as the production and use of chemical substances in the
industrial chain, is collected.
4.2 Determination of benchmark limits
With reference to current regulations or standards, or with the methods of risk
assessment, the benchmark limits of chemical substances in consumer products are
determined.
4.3 Socio-economic analysis
With the socio-economic analysis method, the impact of different chemical substance
limits on consumers, industrial chains, and other related parties is evaluated.
5.2 Collection of consumer-related information
The information on the objects of use, use scenarios, and accident cases of consumer
products is collected, which includes the information on the users, user behavior, use
environment, product characteristics, and injury outcomes. Information collection
methods include but are not limited to:
a) Carry out questionnaire surveys;
b) Conduct behavioral observation experiments;
c) Collect information on personal injuries caused by consumer products;
d) Collect consumer complaint information;
e) Collect domestic and foreign product recall information;
f) Collect product inspection and testing information;
g) Others.
5.3 Collection of information about the industry chain
The information on the production and use of chemical substances in the industrial
chain is collected, which includes the level of chemical substances in consumer
products, the equipment and process and inspection and control methods used for chemical
substances in the production and manufacturing of consumer goods, the information on
alternative chemical substances, as well as the information on costs of the chemical
substances, competition between upstream and downstream enterprises in the industrial
chain, competition among enterprises of the same type, etc. Information collection
methods include but are not limited to:
a) Inquire about relevant domestic and foreign laws, regulations, standards, and
published literature;
b) Query industry databases or statistical yearbooks;
c) Carry out business research;
d) Carry out questionnaire surveys;
e) Carry out expert consultation;
f) Carry out sampling and sample testing;
g) Others.
6 Determination of benchmark limits
6.1 Refer to current regulations or standards
If the limits of chemical substances in the current regulations or standards are adopted
as the benchmark limits of chemical substances in consumer products in which
chemical substance limits are to be formulated, the following conditions shall be met.
a) In the situation that the same chemical substance is used in different consumer
products, when the object of use, method of use, and environment of use of the
two consumer products are the same, the chemical substance limit specified in
the current consumer product regulations or standards can be used as the
benchmark limit of the chemical substance in the consumer product whose
chemical substance limit is to be formulated.
b) For different chemical substances in the same consumer product, only when the
toxicity and harm mechanism of the different chemical substances are the same,
the set chemical substance limit in the consumer product can be used as the
benchmark limit of the chemical substance whose limit is to be formulated in the
consumer product.
c) Sufficient technical information is available to prove the scientific rationality of
the chemical substance limits stipulated in current regulations or standards.
6.2 Methods based on risk assessment
6.2.1 Overview
The benchmark limit can be determined by the risk assessment method, and its main
process includes the derivation of the safety limit, selection of the exposure model,
determination of the values of the parameters in the model, and calculation of the
benchmark limit.
6.2.2 Derivation of safety limits
Safety limits can be derived in two ways:
a) Directly adopt the safety limits from the database of the authoritative chemical
substance toxicity;
b) Deduce safety limits from the toxicity data of chemical substances. For specific
methods, refer to Appe...