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GB 31604.8-2021: Food safety national standard - Food contact materials and products - Determination of total migration
GB 31604.8-2021
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
Food safety national standard - Food contact materials and products - Determination of total migration
ISSUED ON: SEPTEMBER 07, 2021
IMPLEMENTED ON: MARCH 07, 2022
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 
Part One -- Determination of overall migration in water-based food simulants,
chemical alternative solvents ... 4 
2 Principle ... 4 
3 Reagents and materials ... 4 
4 Instruments and equipment... 5 
5 Analysis steps ... 5 
6 Expression of analysis results ... 7 
7 Precision ... 11 
Part Two -- Determination of total migration in olive oil ... 11 
8 Principle ... 11 
9 Reagents and materials ... 12 
10 Instruments and equipment... 14 
11 Analysis steps ... 14 
12 Expression of analysis results ... 20 
13 Precision ... 23 
Annex A Suitability Judgment ... 25 
Annex B Confirmation of moisture-sensitive specimens and adjustment of
moisture content -- Vacuum drying method ... 26 
Annex C Confirmation of moisture-sensitive specimens and adjustment of
moisture content -- Constant humidity method ... 28 
Annex D Typical chromatogram ... 30 
National Food Safety Standard - Food Contact
Materials and Articles Determination of Overall
Migration
1 Scope
This Standard specifies the methods for determination of overall migration for
food contact materials and articles.
This Standard is applicable to the determination of overall migration for food
contact materials and articles.
Part One -- Determination of overall migration in
water-based food simulants, chemical alternative
solvents
2 Principle
The specimen uses water-based food simulants and chemical alternative
solvents [such as n-hexane, isooctane, 95% (volume fraction) ethanol solution,
n-heptane]. Perform migration test under selected migration test conditions.
Evaporate and dry the soaking liquid obtained from the migration test. After
deducting the corresponding blanks, the total amount of all non-volatile
substances migrated from the specimen to water-based food simulants and
chemical substitute solvents is obtained.
3 Reagents and materials
Unless otherwise specified, the reagents used in this method are analytically
pure, and the water is grade two water specified in GB/T 6682.
3.1 Reagents
3.1.1 Absolute ethanol (C2H6O).
3.1.2 Acetic acid (C2H4O2).
chemical substitute solvents
Wash and drain the evaporating dish before use. Dry for 2h in a 100°C±5°C
electric heating constant temperature drying oven. Then weigh it after cooling
for 0.5h in a desiccator. Repeat drying, cooling, and weighing until constant
weight (that is, the difference in mass between the two weighings does not
exceed 0.5mg). The last weighed mass is the mass of the empty evaporating
dish.
Take an empty evaporating dish with constant weight. Add 200mL of the
soaking solution obtained from the migration test to it (if the evaporating dish
specification is < 200mL, it needs to be evaporated to dryness in batches).
Place it in a water bath that is not higher than the boiling point of each soaking
solution 10°C and evaporate to dryness. Use filter paper or dust-free wipes to
absorb the water droplets on the bottom of the evaporating dish (no paper fibers
remain at the bottom of the evaporating dish). Then put the evaporating dish in
a 100°C±5°C electric heating constant temperature drying box to dry for 2h.
Take it out. Cool in a desiccator for 0.5h. Weigh it. Repeat drying, cooling, and
weighing until constant weight. The last weighed mass is the mass of the
evaporating dish with specimen evaporation residue. The mass of the
evaporating dish with the evaporation residue of the specimen minus the mass
of the empty evaporating dish is the mass of the soaking solution residue for
the specimen determination.
5.3 Determination of trichloromethane extract
The determination steps are applicable to food contact materials and articles
that require the detection of chloroform extracts in the product standard.
Add 20mL of chloroform to the residue obtained in 5.2. Wetting the residue. Use
the filter paper to filter. Collect the filtrate into an evaporating dish with constant
weight. Then use 20mL of chloroform to extract the residue twice respectively.
Use a little chloroform to rinse the filter paper. The filtrate is incorporated into
the evaporating dish. Steam to dry according to step 5.2. Obtain the mass of
the residue extracted with chloroform from the soaking solution for the
specimen determination.
5.4 Blank test
Treat water-based food simulants, chemical alternative solvents, and
chloroform that are not in contact with food contact materials and articles
according to 5.1, 5.2, and 5.3. Obtain the residue mass of the blank soaking
solution and the residue mass of the blank soaking solution extracted with
chloroform.
X6 - Total migration of product contact materials and articles after chloroform
extraction, in milligrams per square decimeter (mg/dm2);
F - Under foreseeable use cases, the ratio between the area of food contact
materials and articles that actually contact the food and the mass of the food
(S/V), in square decimeter per kilogram (dm2/kg). The density of various liquid
foods is usually calculated as 1kg/L. Convert its volume into the corresponding
food mass. When the actual S/V is known, F is the maximum S/V under the
foreseeable use case. When the actual S/V is unknown, F uses 6dm2/kg, that
is, 6dm2 of food contact materials and articles contact 1kg of food.
6.3 Correction of results
When GB 31604.1 stipulates the correction factor for fat-containing food
simulants, the determination results of the chemical solvent substitution test
shall be divided by the corresponding correction factor.
6.4 Expression of results
The calculation result of the total migration amount is expressed as the
arithmetic mean of the two parallel determination results obtained under the
repeatability condition. The calculation result is accurate to one decimal place.
7 Precision
When the total migration result is ≤ 10.0mg/dm2 or 60.0mg/kg, the difference
between the two independent determination results obtained under
repeatability conditions and the arithmetic mean shall not exceed 1.0mg/dm2 or
6.0mg/kg. The determination result after applying the correction factor shall also
meet this requirement.
When the total migration result is > 10.0mg/dm2 or 60.0mg/kg, the difference
between the two independent determination results obtained under
repeatability conditions and the arithmetic mean shall not exceed 10% of the
arithmetic mean. The determination result after applying the correction factor
shall also meet this requirement.
Part Two -- Determination of total migration in olive oil
8 Principle
The specimen uses olive oil as a food simulant. The migration test is carried
out under the selected conditions. The total migration is determined by the
(accurate to 0.1g) potassium hydroxide and dissolve it in 500mL of methanol.
Mix well.
9.2.3 Saturated sodium sulfate solution: Weigh 50g (accurate to 0.1g) of
anhydrous sodium sulfate in a 250mL beaker. Add 100mL of water on the
electric hot plate and boil to dissolve. After cooling to room temperature, use a
funnel equipped with qualitative filter paper to filter into a ...