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GB 31604.1-2023 English PDF (GB31604.1-2023)

GB 31604.1-2023 English PDF (GB31604.1-2023)

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GB 31604.1-2023: National food safety standard - General rules for migration test of food contact materials and products

This document specifies the terms and definitions, basic requirements, selection of food simulants, selection of migration testing conditions, screening methods, chemical solvent substitution test, migration testing result correction and migration testing result selection of various food contact materials and products. 2 Terms and definitions 2.1 Migration testing Migration testing refers to a test conducted under specified conditions to determine the amount of migration of components of food contact materials and products into test medium such as food or food simulants in contact with them. Migration testing includes specific migration testing, total migration testing and chemical solvent substitution test. 2.2 Food simulant Food simulant is a test medium used to simulate food for migration testing. It can closely reflect the migration of components in food contact materials and products into the food in contact with them, and has the typical common characteristics of certain types of food. 2.3 Screening method It is a method that uses the amount used, total migration amount or residue amount to screen for specific migration (total) amount, so as to verify the compliance of a specific migration (total) amount of a certain (category) substance in food contact materials and products. 2.4 Chemical solvent substitution test A migration testing conducted under specified conditions using chemical solvents to replace oily food simulants. 2.5 Reusable food contact materials and products Food contact materials and products that have been or are expected to be used multiple times and come into repeated contact with food. GB 31604.1-2023 www.ChineseStandard.net ? Buy True-PDF ? Auto-delivery. Page 5 of 19 3 Basic requirements 3.1 To measure the total migration amount of food contact materials and products, food simulants shall be selected and migration testing shall be conducted in accordance with the provisions of this Standard. 3.2 Regarding the determination of the specif...
GB 31604.1-2023
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National Food Safety Standards -- General Principles for
Migration testing of Food Contact Materials and Products
ISSUED ON: SEPTEMBER 06, 2023
IMPLEMENTED ON: SEPTEMBER 06, 2024
Issued by: National Health Commission of the People's Republic of China; State Administration for Market Regulation.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Terms and definitions ... 4
3 Basic requirements ... 5
4 Selection of food simulants ... 6
5 Selection of migration testing conditions ... 8
6 Screening methods ... 10
7 Chemical solvent substitution testing ... 11
8 Migration testing result correction ... 11
9 Selection of migration testing results ... 13
Annex A Selection of food categories and food simulants ... 14
National Food Safety Standards -- General Principles for
Migration testing of Food Contact Materials and Products
1 Scope
This document specifies the terms and definitions, basic requirements, selection of food simulants, selection of migration testing conditions, screening methods, chemical solvent substitution test, migration testing result correction and migration testing result selection of various food contact materials and products.
2 Terms and definitions
2.1 Migration testing
Migration testing refers to a test conducted under specified conditions to determine the amount of migration of components of food contact materials and products into test medium such as food or food simulants in contact with them. Migration testing includes specific migration testing, total migration testing and chemical solvent substitution test. 2.2 Food simulant
Food simulant is a test medium used to simulate food for migration testing. It can closely reflect the migration of components in food contact materials and products into the food in contact with them, and has the typical common characteristics of certain types of food.
2.3 Screening method
It is a method that uses the amount used, total migration amount or residue amount to screen for specific migration (total) amount, so as to verify the compliance of a specific migration (total) amount of a certain (category) substance in food contact materials and products.
2.4 Chemical solvent substitution test
A migration testing conducted under specified conditions using chemical solvents to replace oily food simulants.
2.5 Reusable food contact materials and products
Food contact materials and products that have been or are expected to be used multiple times and come into repeated contact with food.
3 Basic requirements
3.1 To measure the total migration amount of food contact materials and products, food simulants shall be selected and migration testing shall be conducted in accordance with the provisions of this Standard.
3.2 Regarding the determination of the specific migration (total) amount of food contact materials and products, for materials and products that have been in contact with food, the food in contact with them shall be directly tested, or materials and products that have not been in contact with food shall be selected to use food simulants for migration testing. For materials and products that have not come into contact with food, food or food simulants shall be selected for testing.
3.3 Food simulants and migration testing conditions shall reflect actual use situations as closely as possible. When food contact materials and products have clear intended use conditions, the most stringent test conditions (the conditions that result in the highest migration amount) shall be selected based on the expected use conditions. When the most severe test conditions cannot be determined, all conditions corresponding to the actual usage conditions shall be selected for testing. When there are no clear intended use conditions for food contact materials and products, the most stringent test conditions supported by scientific evidence shall be selected.
3.4 The migration testing shall not cause the test sample to undergo changes in physical properties or other changes (such as deformation, melting, etc.) that would not occur under normal use conditions. If the above changes occur during the migration testing, test conditions that are no lower than the actual contact conditions or other food simulants with scientific evidence shall be selected for the migration testing. 3.5 For migration testing, the final product (or sheet or specimen) shall be selected for migration testing. For food contact materials (such as resin or granules, coatings, inks, adhesives, etc.) that are significantly different from actual molded products, the final product (or sheet, specimen) shall be made into a migration testing according to the actual processing conditions. The specific requirements of the final product (or sheet or specimen) shall comply with the provisions of GB 5009.156 and other national food safety standards.
3.6 When conducting migration testing on multi-material food contact materials and products, the migration testing can be conducted on the entire final product or on each material separately.
3.6.1 When conducting migration testing on composite materials and finished products, and coated finished products as a whole, the selection of food simulants and migration testing conditions shall be carried out in accordance with the provisions of the national food safety standards for materials in direct contact with food layers. For items to be tested that only come from non-direct food contact layers, the selection of food amount of the corresponding substance in the production of the food contact materials and products. When converting, it shall be assumed that the added substance(s) will all migrate into the food or food simulant. Calculation is based on the volume or mass of the product expected to contact food and the corresponding contact area. 7 Chemical solvent substitution testing
7.1 For foods containing oil, chemical solvents such as 95% (volume fraction) ethanol, n-hexane, n-heptane, isooctane, etc. can be used to replace oil-containing food simulants to conduct chemical solvent substitution tests.
7.2 The chemical solvent substitution test shall adopt the most stringent test conditions supported by scientific evidence and that can most truly reflect the migration status of actual fat-containing foods or corresponding food simulants.
8 Migration testing result correction
8.1 Area to volume ratio
8.1.1 The ratio (S/V) of the contact area (S) to the food mass or volume (V) of food contact materials and products used in the calculation of migration testing results shall be able to reflect the most stringent actual use situation (such as the smallest packaging). The density of liquid food shall be calculated as 1 kg/L.
8.1.2 For container-type food contact materials and products, if the container has a scale or a nominal capacity and no minimum capacity requirement, V is measured in terms of the volume corresponding to the maximum scale or nominal capacity, and S is measured in terms of the inner surface area corresponding to the maximum scale or nominal capacity. If the container has a minimum capacity requirement, V is measured in terms of the volume corresponding to the minimum scale, and S is measured in terms of the inner surface area corresponding to the minimum scale. If the container has no scale and no nominal capacity, the distance between the liquid level of the food simulant and the upper edge (overflow surface) of the hollow product shall be 1 cm or the S/V corresponding to 4/5 of the volume of the hollow product to be heated and boiled shall be selected for calculation of migration testing results.
8.1.3 For food contact materials and products such as bottle caps, gaskets, and sealing rings, the calculation of S/V shall include the area or volume of the container to which they are adapted. If there is no information on suitable containers, it shall be calculated based on the migration amount in each product (such as mg/piece).
8.1.4 The S/V of conveyor belts, pipes, gaskets, valves and other spare parts in food processing equipment that are in dynamic contact with food shall be estimated based on their actual contact with food (such as based on equipment parameters). 8.1.5 When the S/V is unknown, the migration testing results are calculated using 6 dm2 of food contact materials and products in contact with 1 kg of food.
8.2 Fat correction factor
8.2.1 For foods with a fat content of more than 20%, the fat reduction factor (FRF) shall be used to correct the specific migration amount of lipophilic substances according to formula (1).
Where,
5 - Conversion coefficient;
f - Fat content in food, in grams per hundred grams (g/100 g);
100 - Conversion coefficient.
8.2.2 Principles of using FRF:
a) The specific migration level in the food or food simulant must not exceed 60 mg/kg before correction using the FRF factor;
b) When comparing to a specific migration limit, the specific migration testing result shall be divided by the FRF.
8.2.3 FRF shall not be used for calibration under the following circumstances: a) Special food contact materials and products for infants and young children; b) Substances with a specific migration limit of "not to be detected";
c) When the S/V is unknown, use 6 dm2/kg to calculate the specific migration amount. 8.3 Correction factors for fatty food simulants
8.3.1 The migration testing results of vegetable oil and other fat-containing food simulants in Table A.1 shall be divided by the correction factor of fat-containing food simulants (the corresponding value in Table A.1). Compliance determination is made after calibration.
8.3.2 The correction factor for food simulants containing fats and oils is not applicable to substances with a specific migration limit of "not to be detected".
8.4 The test results of the specific migration amount of lipophilic substances in oil- containing food simulants shall be corrected by using the product of the fat correction factor and the correction factor of oil-containing food simulants. When the product of the two correction factors is not greater than 5, it shall be calculated as the actual product. When it is greater than 5, it shall be calculated as 5.
9 Selection of migration testing results
9.1 For reused food contact materials and products, the same test sample or the same specimen shall be subjected to migration testing three times. Use 1 new food simulant each time. The result of the third migration testing shall be the final result of the migration testing. If there is indeed evidence that the migration amount in the first migration testing does not exceed the migration limit and the migration amount in the second and third migration testing will not increase, multiple migration testing will not be conducted. Potassium permanganate consumption and heavy metals (in Pb) are tested only once.
9.2 For reused food contact materials and products, for substances that cannot be detected with specific migration limits, the results of the first migration testing shall be used as the final migration testing result.
9.3 When the screening results meet specific migration (total) limit requirements, the screening results can be used as the final result. When the screening results do not meet the limit requirements, specific migration testing shall be conducted in accordance with the requirements of this Standard. Take the migration testing results as the final result. When migration testing techniques are not feasible, screening results shall be used as the final result.
9.4 When the chemical solvent substitution test results meet the limit requirements, the substitute test results can be used as the final result. When the chemical solvent substitution test results do not meet the limit requirements, a migration testing for oily food simulants shall be conducted. Take the migration testing results as the final result. When it is not technically feasible to use oily food simulants for migration testing, the alternative test results shall be used as the final migration testing results.

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