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GB 31604.1-2015 English PDF (GB31604.1-2015)

GB 31604.1-2015 English PDF (GB31604.1-2015)

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GB 31604.1-2015: National food safety standard -- General Principle for the Migration Test of Food Contact Materials and Their Products

This standard specifies the general requirements for the migration test of various food contact materials and products.
GB 31604.1-2015
GB
NATIONAL STANDARD
OF THE PEOPLE 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...

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