GB 31604.1-2023 PDF in English
GB 31604.1-2023 (GB31604.1-2023) PDF English
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National food safety standard - General rules for migration test of food contact materials and products
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| GB 31604.1-2015 | English | 95 |
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National food safety standard -- General Principle for the Migration Test of Food Contact Materials and Their Products
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Standards related to (historical): GB 31604.1-2023
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GB 31604.1-2023: PDF in English 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.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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