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GB 31604.59-2023 English PDF (GB31604.59-2023)
GB 31604.59-2023 English PDF (GB31604.59-2023)
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GB 31604.59-2023: National food safety standard - Food contact materials and products - General rules for verification of chemical analysis methods
GB 31604.59-2023
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National Food Safety Standard - Food Contact Materials
and Products - General Rules for Verification of Chemical
Analysis Methods
ISSUED ON. SEPTEMBER 6, 2023
IMPLEMENTED ON. SEPTEMBER 6, 2024
Issued by. National Health Commission of the People’s Republic of China;
State Administration for Market Regulation.
Table of Contents
1 Scope... 3
2 Terms and Definitions... 3
3 General Requirements for the Verification of Chemical Analysis Methods for Food
Contact Materials and Products... 3
4 Verification of Analysis Method for Residue... 4
4.1 Selection of Representative Materials (or products) and Requirements for Verification
Samples... 4
4.2 Verification of Performance Parameters of Analysis Method for Residue... 6
4.3 Method Equivalence Verification... 12
4.4 Requirements for Data Processing... 13
5 Verification of Analysis Method for Specific Migration Amount... 13
5.1 Selection of Representative Materials (or products), and Food Simulants, and
Requirements for Soaking Solutions for Verification... 13
5.2 Verification of Performance Parameters of Analysis Method for Target Analyte Content
in Soaking Solution... 14
5.3 Conversion of Target Analyte Content in the Soaking Solution and Specific Migration
Amount... 19
5.4 Method Equivalence Verification... 20
5.5 Requirements for Data Processing... 20
Appendix A Classification of Materials Used for the Verification of Chemical Analysis
Methods for Food Contact Materials and Products... 21
National Food Safety Standard - Food Contact Materials
and Products - General Rules for Verification of Chemical
Analysis Methods
1 Scope
This Standard specifies general requirements for the verification of chemical analysis methods
for food contact materials and products.
This Standard is applicable to the verification of the formulation and revision process of
chemical analysis methods for food contact materials and products in national food safety
standards.
2 Terms and Definitions
What is defined in GB 5009.295-2023 and the following terms and definitions are applicable
to this document.
2.1 Chemical Alternative Solvents
Chemical solvents used to replace oil-containing food simulants (vegetable oil) in chemical
solvent substitution test, such as. 95% (volume fraction) ethanol solution, isooctane, n-hexane
and n-heptane, etc.
2.2 Soaking Solution
The solution obtained after food contact materials and products undergo a migration test with
food simulants or chemical alternative solvents.
3 General Requirements for the Verification of Chemical
Analysis Methods for Food Contact Materials and Products
3.1 For qualitative method, intra-laboratory and inter-laboratory verification parameters shall
include the specificity and detection limit of the method.
3.2 For quantitative method, intra-laboratory verification parameters shall include the
specificity, detection limit, quantification limit, determination range, accuracy and repeatability
of the method; inter-laboratory verification parameters shall include the detection limit,
quantification limit, determination range, accuracy and reproducibility of the method.
each type of food contact materials, select at least one subtype of food contact materials. For
each subtype, select at least one representative material (or product).
4.1.1.4 When selecting composite materials and products for food contact for the method
verification, the number of types of food contact materials covered shall be calculated based on
the types corresponding to the materials of each layer within the effective barrier layer.
4.1.2 Requirements for verification samples
4.1.2.1 Verification samples can be selected from certified reference materials / standard
samples, quality control samples that comply with the proficiency verification requirements, or
standard addition samples.
4.1.2.2 When selecting certified reference materials / standard samples for verification, there
shall be at least 3 concentration levels, including the lowest concentration, intermediate
concentration (generally, the concentration of concern) and the highest concentration of the
determination range of the method.
4.1.2.3 When selecting quality control samples that comply with the proficiency verification
requirements, the verification samples must satisfy the following conditions.
a) The selection of sample matrix shall be representative and satisfy the expected use of
the method;
b) For a sample matrix, at least 3 concentration addition levels are required, including
the lowest concentration, intermediate concentration (generally, the concentration of
concern) and the highest concentration of the determination range of the method. In
addition, their uniformity and stability shall be tested.
4.1.2.4 When selecting standard addition samples for verification, the verification samples can
be prepared in accordance with the following method.
a) The selection of sample matrix shall be representative and satisfy the expected use of
the method;
b) For the selected representative material (or product), after homogenizing it in
accordance with the method, add the target analyte to it. At least 3 concentrations are
required to be added, including the lowest concentration, intermediate concentration
(generally, the concentration of concern) and the highest concentration of the
determination range of the method.
4.1.3 Sample storage and transportation
4.1.3.1 When it is necessary to send and transport the verification samples, each sample shall
be individually sealed and packaged, and the packaging used shall not contain substances that
may affect the detection of the target analyte. Severe friction or collision of samples during
transportation shall be avoided.
4.1.3.2 If the target analyte is a volatile substance, effective measures shall be taken to avoid
losses caused by the volatilization of the target analyte during the transportation of the samples,
such as. multiple sealing of the samples and maintaining at a low temperature, etc.
4.2 Verification of Performance Parameters of Analysis Method for Residue
4.2.1 Specificity
4.2.1.1 Verification requirements
The analysis method’s capability of distinguishing the target analyte from other substances
(including but not limited to impurity components, such as. isomers and homologues that may
be included in the industrial grade target analyte, and oxidation / reduction / decomposition /
hydrolysis / pyrolysis that may occur during industrial production of the target analyte, as well
as matrix components, etc.) shall be verified. There shall be no interference factors (signals and
interference peaks, etc.) that may lead to errors in the qualitative determination of the target
analyte and affect the accuracy of the quantitative determination.
4.2.1.2 Verification method
Analyze representative samples that match the scope of application of the method, and check
whether there are interferences (signals and peaks, etc.) that may lead to errors in the qualitative
determination of the target analyte and / or affect the accuracy of the quantitative determination;
add a certain concentration of substances that may interfere with the qualitative and / or
quantitative determination of the target analyte to the representative materials (or products),
then, perform analysis to check whether these interfering substances can be effectively
identified.
4.2.2 Detec...
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GB 31604.59-2023: National food safety standard - Food contact materials and products - General rules for verification of chemical analysis methods
GB 31604.59-2023
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National Food Safety Standard - Food Contact Materials
and Products - General Rules for Verification of Chemical
Analysis Methods
ISSUED ON. SEPTEMBER 6, 2023
IMPLEMENTED ON. SEPTEMBER 6, 2024
Issued by. National Health Commission of the People’s Republic of China;
State Administration for Market Regulation.
Table of Contents
1 Scope... 3
2 Terms and Definitions... 3
3 General Requirements for the Verification of Chemical Analysis Methods for Food
Contact Materials and Products... 3
4 Verification of Analysis Method for Residue... 4
4.1 Selection of Representative Materials (or products) and Requirements for Verification
Samples... 4
4.2 Verification of Performance Parameters of Analysis Method for Residue... 6
4.3 Method Equivalence Verification... 12
4.4 Requirements for Data Processing... 13
5 Verification of Analysis Method for Specific Migration Amount... 13
5.1 Selection of Representative Materials (or products), and Food Simulants, and
Requirements for Soaking Solutions for Verification... 13
5.2 Verification of Performance Parameters of Analysis Method for Target Analyte Content
in Soaking Solution... 14
5.3 Conversion of Target Analyte Content in the Soaking Solution and Specific Migration
Amount... 19
5.4 Method Equivalence Verification... 20
5.5 Requirements for Data Processing... 20
Appendix A Classification of Materials Used for the Verification of Chemical Analysis
Methods for Food Contact Materials and Products... 21
National Food Safety Standard - Food Contact Materials
and Products - General Rules for Verification of Chemical
Analysis Methods
1 Scope
This Standard specifies general requirements for the verification of chemical analysis methods
for food contact materials and products.
This Standard is applicable to the verification of the formulation and revision process of
chemical analysis methods for food contact materials and products in national food safety
standards.
2 Terms and Definitions
What is defined in GB 5009.295-2023 and the following terms and definitions are applicable
to this document.
2.1 Chemical Alternative Solvents
Chemical solvents used to replace oil-containing food simulants (vegetable oil) in chemical
solvent substitution test, such as. 95% (volume fraction) ethanol solution, isooctane, n-hexane
and n-heptane, etc.
2.2 Soaking Solution
The solution obtained after food contact materials and products undergo a migration test with
food simulants or chemical alternative solvents.
3 General Requirements for the Verification of Chemical
Analysis Methods for Food Contact Materials and Products
3.1 For qualitative method, intra-laboratory and inter-laboratory verification parameters shall
include the specificity and detection limit of the method.
3.2 For quantitative method, intra-laboratory verification parameters shall include the
specificity, detection limit, quantification limit, determination range, accuracy and repeatability
of the method; inter-laboratory verification parameters shall include the detection limit,
quantification limit, determination range, accuracy and reproducibility of the method.
each type of food contact materials, select at least one subtype of food contact materials. For
each subtype, select at least one representative material (or product).
4.1.1.4 When selecting composite materials and products for food contact for the method
verification, the number of types of food contact materials covered shall be calculated based on
the types corresponding to the materials of each layer within the effective barrier layer.
4.1.2 Requirements for verification samples
4.1.2.1 Verification samples can be selected from certified reference materials / standard
samples, quality control samples that comply with the proficiency verification requirements, or
standard addition samples.
4.1.2.2 When selecting certified reference materials / standard samples for verification, there
shall be at least 3 concentration levels, including the lowest concentration, intermediate
concentration (generally, the concentration of concern) and the highest concentration of the
determination range of the method.
4.1.2.3 When selecting quality control samples that comply with the proficiency verification
requirements, the verification samples must satisfy the following conditions.
a) The selection of sample matrix shall be representative and satisfy the expected use of
the method;
b) For a sample matrix, at least 3 concentration addition levels are required, including
the lowest concentration, intermediate concentration (generally, the concentration of
concern) and the highest concentration of the determination range of the method. In
addition, their uniformity and stability shall be tested.
4.1.2.4 When selecting standard addition samples for verification, the verification samples can
be prepared in accordance with the following method.
a) The selection of sample matrix shall be representative and satisfy the expected use of
the method;
b) For the selected representative material (or product), after homogenizing it in
accordance with the method, add the target analyte to it. At least 3 concentrations are
required to be added, including the lowest concentration, intermediate concentration
(generally, the concentration of concern) and the highest concentration of the
determination range of the method.
4.1.3 Sample storage and transportation
4.1.3.1 When it is necessary to send and transport the verification samples, each sample shall
be individually sealed and packaged, and the packaging used shall not contain substances that
may affect the detection of the target analyte. Severe friction or collision of samples during
transportation shall be avoided.
4.1.3.2 If the target analyte is a volatile substance, effective measures shall be taken to avoid
losses caused by the volatilization of the target analyte during the transportation of the samples,
such as. multiple sealing of the samples and maintaining at a low temperature, etc.
4.2 Verification of Performance Parameters of Analysis Method for Residue
4.2.1 Specificity
4.2.1.1 Verification requirements
The analysis method’s capability of distinguishing the target analyte from other substances
(including but not limited to impurity components, such as. isomers and homologues that may
be included in the industrial grade target analyte, and oxidation / reduction / decomposition /
hydrolysis / pyrolysis that may occur during industrial production of the target analyte, as well
as matrix components, etc.) shall be verified. There shall be no interference factors (signals and
interference peaks, etc.) that may lead to errors in the qualitative determination of the target
analyte and affect the accuracy of the quantitative determination.
4.2.1.2 Verification method
Analyze representative samples that match the scope of application of the method, and check
whether there are interferences (signals and peaks, etc.) that may lead to errors in the qualitative
determination of the target analyte and / or affect the accuracy of the quantitative determination;
add a certain concentration of substances that may interfere with the qualitative and / or
quantitative determination of the target analyte to the representative materials (or products),
then, perform analysis to check whether these interfering substances can be effectively
identified.
4.2.2 Detec...
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