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National food safety standard - General rules for migration test of food contact materials and products
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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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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.
......
GB 31604.1-2015
GB
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
National Food Safety Standard
General Rules for Migration Test of
Food Contact Materials and Products
ISSUED ON. SEPTEMBER 22, 2015
IMPLEMENTED ON. SEPTEMBER 22, 2016
Issued by. National Health and Family Planning Commission of the People's
Republic of China
Table of Contents
1 Scope ... 3
2 Terms and Definitions ... 3
3 Basic Requirements ... 4
4 Selection of Food Simulants ... 5
5 Selection of Migration Test Conditions ... 6
6 Screening Test and Chemical Solvent Substitution Test ... 8
7 Results Correction ... 9
Appendix A Selection of Food Categories and Food Simulants... 11
National Food Safety Standard
General Rules for Migration Test of
Food Contact Materials and Products
1 Scope
This standard specifies the general requirements for the migration test of various food
contact materials and products.
2 Terms and Definitions
2.1 Migration test
A test that is conducted under specified conditions for the determination of the migration
volume of components of food contact materials and products that are migrating to the
foods or food simulants in contact therewith.
2.2 Food simulants
A type of testing medium, which can almost-truly reflect the component migration of food
contact materials and products that are migrating to the foods in contact therewith. It has
the typical common characteristics of some kind of foods, and is used for simulating the
food migration test.
2.3 Screening test
A test method that is used to verify whether the specific migration volume of certain
substances in the food contact materials and products or the total migration volume meets
the specified requirements, by determining the total migration volume or the residual
quantity to estimate the specific migration volume and determining the residual quantity to
estimate the total migration volume.
2.4 Chemical solvent substitution test and extraction volume
In order to verify the migration volume of certain food contact materials and products, a
chemical solvent with scientific evidences and whose test result is higher than specified
food simulant is adopted to substitute for a fatty food stimulant. The test conducted under
the specified condition is called chemical solvent substitution test or extraction test, and
the measured result is called extraction volume.
2.5 Repeatedly used food contact materials and products
Food contact materials and products which have been or are expected to be used
repeatedly and which repeatedly contact with food.
3 Basic Requirements
3.1 For the determination of total migration volume of food contact materials and products,
the migration test shall be conducted in accordance with the requirements of this
standard.
3.2 For the determination of specific migration volume of certain substances in the food
contact materials and products, the specific migration volume of certain substances in the
foods in contact therewith shall be directly tested for the materials and products in contact
with foods. For those which have been in contact with food but have no detection method
yet or the specific migration volume cannot be detected due to experimental technology,
or for the determination of specific migration volume of materials and products which have
not been in contact with food, the migration test shall be conducted in accordance with the
requirements of this standard.
3.3 The ratio (S/V) of the contact area (S) of the food contact materials AND the volume (v)
of the food or food simulants, at the time of the migration test, shall reflect the actual use
conditions and shall adopt the maximum S/V ratio (such as the minimum package) under
the foreseeable use condition. When the value cannot be estimated, it generally adopts 6
dm2 food contact materials and the products that contact with 1kg of food or food simulant.
The density of various liquid food is usually calculated as 1 kg/L.
3.4 The migration test condition shall reflect the actual use condition as far as possible,
and the most severe condition (such as the maximum usage temperature and / or
maximum usage time) shall be selected under the foreseeable use condition; If the usage
time and temperature cannot be determined, the most severe test temperature and time
supported by scientific evidence shall be selected.
3.5 The migration test shall not result in changes in the physical properties (such as
deformation, melting, swelling) of the test samples that do not occur under normal use
condition or lead to precipitation, turbidity and other changes in the food simulants. If the
changes in the test sample or food simulant are observed during the migration test, the
migration test shall be carried out again under actual use conditions where such changes
do not occur or by choosing other scientifically supported food simulants.
3.6 For the food contact materials (such as resin or pellets, paints, printing inks, adhesives)
which are significantly different from the actual molded product, the molded product (or
sheet or specimen) shall be made to conduct the migration test according to the actual
processing conditions; the specific requirements for molded product (or sheets, samples)
Test
6.1 Screening test for total migration volume
The specific migration volume of non-volatile materials can be estimated by adopting the
total migration volume determined under the same specific migration test conditions or
more severe test conditions; when the total migration volume is less than the specific
migration volume, the determination of specific migration volume can be exempted.
6.2 Screening test for residual quantity
For certain processing agent or additives which are used less frequently, as well as
substances which are unstable in food or food simulant or the substances which have no
analytical method yet, their specific migration volume can be estimated by determining the
residual quantity of this substance in the food contact materials and products. When the
migration volume, converted by the measured residual quantity according to the
corresponding conversion method, is less than the specific migration volume, then the
determination of specific migration volume can be exempted.
6.3 Chemical solvent substitution test
6.3.1 For oil and fat food, 95% (volume fraction) of chemical solvents such as ethanol,
n-hexane, n-heptane, isooctane which have high extraction ability can substitute for the oil
and fat food simulants, so as to determine the solvent extraction volume of materials and
products. When the amount of solvent extraction follows the requirements of total
migration volume limit or the specific migration volume limit, the migration test of the fat
and oil food simulants can be exempted. When the amount of extraction does not meet
the requirements of migration limit or specific migration volume, the migration test of fat
and oil food simulants shall be conducted, and the compliance judgement shall be made
based on the migration volume in the fat and oil food simulants.
6.3.2 Chemical solvent substitution test conditions shall be the most severe and
scientifically supported test conditions, which can most-truly reflect the migration
conditions of actual oil and fat food or the corresponding food simulants.
7 Results Correction
The results of the measurements shall be corrected by the following correction factors
with reference to the requirements of Appendix A.
a) Ratio of surface area, that food contact materials and products contact with the food
simulant, TO the volume;
Appendix A
Selection of Food Categories and Food Simulants
A.1 The selection of categories of foods that are expected to be in contact with food
contact materials and their products AND the corresponding food simulants shall follow
the requirements of Table A.1.
Table A.1 Selection of Food Categories and Corresponding Food Simulants
Food
classification
No.
Food Category
Food simulants a
10%
(volume
fraction)
ethanol
4%
(volume
fraction)
acetic acid
20%
(volume
fraction)
Ethanol
50% (volume
fraction)
Ethanol
Vegetable
oil b
01 Beverages
01.01
Non-alcoholic beverages or
alcoholic beverages with
alcohol content ≤10% (volume
fraction)
01.01.01
Transparent and clarified
beverages. including water,
apple juice, fruit and vegetable
juice, fruit juice, lemonade,
syrup, coffee, tea, beer, soft
drinks, energy drinks and the
analogue, flavor drinks, etc.
X Xc
01.01.02
Turbid beverage. Including
fruit and vegetable juice
containing fruit-pulp, syrup
and other soft drinks, liquid
chocolates, etc.
Xc X
01.02 Alcoholic beverages
01.02.01
10% (volume fraction)
< ethanol content ≤20%
(volume fraction) alcoholic
beverage
Xc X
01.02.02
Alcoholic beverages those
alcohol content is more than
20% and less than or equal to
50% (volume fraction),
including various milk wine
Xc X
01.02.03
Alcoholic beverages or edible
whose alcohol ethanol content
is more than 50% (volume
fraction)
Xc
Ethanol of actual
concentration or
95% of ethanol
substitute
02 Cereals, beans and their products
02.01 Starch
02.02
Cereals, including t...
......
| Standard ID | GB 31604.1-2023 (GB31604.1-2023) | | Description (Translated English) | (National food safety standards Inks for food contact materials and products) | | Sector / Industry | National Standard | | Classification of Chinese Standard | X09 | | Word Count Estimation | 8,864 | | Date of Issue | 2023-09-06 | | Date of Implementation | 2024-09-06 | | Issuing agency(ies) | National Health Commission of the People's Republic of China, State Administration for Market Regulation | | Summary | This standard applies to inks used in food contact materials and products and the printing ink layers formed thereon. | | Standard ID | GB 31604.1-2015 (GB31604.1-2015) | | Description (Translated English) | National food safety standard -- General Principle for the Migration Test of Food Contact Materials and Their Products | | Sector / Industry | National Standard | | Classification of Chinese Standard | X09 | | Word Count Estimation | 15,149 | | Date of Issue | 2015-09-22 | | Date of Implementation | 2016-09-22 | | Regulation (derived from) | PRC National Health and Family Planning Commission 2015 No.8 | | Issuing agency(ies) | National Health and Family Planning Commission of the People's Republic of China | | Standard ID | () | | Description (Translated English) | (Technical specifications for ceramic capacitive sensor type partial discharge monitoring devices of 35kV and below) | | Sector / Industry | Chinese Industry Standard | | Date of Issue | 2023-10-11 | | Date of Implementation | 2024-04-11 | | Issuing agency(ies) | National Energy Board |
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