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食品安全国家标准 食品接触材料及制品迁移试验通则
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GB 31604.1-2015
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标准编号: GB 31604.1-2015 (GB31604.1-2015)
中文名称: 食品安全国家标准 食品接触材料及制品迁移试验通则
英文名称: National food safety standard -- General Principle for the Migration Test of Food Contact Materials and Their Products
行业: 国家标准
中标分类: X09
字数估计: 15,176
发布日期: 2015-09-22
实施日期: 2016-09-22
标准依据: 中华人民共和国国家卫生和计划生育委员会2015年 第8号
发布机构: 中华人民共和国国家卫生和计划生育委员会
GB 31604.1-2015: 食品安全国家标准 食品接触材料及制品迁移试验通则
GB 31604.1-2015 英文名称: National food safety standard -- General Principle for the Migration Test of Food Contact Materials and Their Products
中华人民共和国国家标准
食品安全国家标准
食品接触材料及制品迁移试验通则
中 华 人 民 共 和 国
国家卫生和计划生育委员会 发 布
食品安全国家标准
食品接触材料及制品迁移试验通则
1 范围
本标准规定了各类食品接触材料及制品迁移试验的通用要求。
2 术语和定义
3 基本要求
3.1 食品接触材料及制品的总迁移量的测定,应按照本标准的规定进行迁移试验。
3.2 食品接触材料及制品中某种或某类物质特定迁移量的测定,对于已与食品接触的材料及制品,应
直接检测与之接触的食品中某种或某类物质的特定迁移量;对于已与食品接触但尚无检测方法或因实
验技术原因无法检测特定迁移量的,或尚未与食品接触的材料及制品的特定迁移量的测定,应按照本标
准的规定进行迁移试验。
3.3 进行迁移试验时,食品接触材料及制品的接触面积(S)与食品或食品模拟物体积(V)的比(S/V)
应反映实际的使用情形,且应取可预见使用情形下的最大S/V 比(如最小包装),当无法估算该值时,一般
采用6dm2食品接触材料及制品接触1kg的食品或食品模拟物,各种液态食品的密度通常以1kg/L计。
3.4 迁移试验条件应尽可能反映实际使用条件,在可预见的使用情形下应选择最严苛的试验条件(如
最高使用温度和/或最长使用时间);在尚无法确定使用时间和温度的情形下应选择有科学证据支持的
最严苛的测试温度和时间。
3.5 迁移试验不应导致测试样品发生在正常使用条件下不会发生的物理性能(如变形、融化、溶胀等)
的改变或导致食品模拟物出现沉淀、浑浊等其他改变。如在迁移试验过程中发现测试样品或食品模拟
物出现上述变化﹐则应在不会发生此类改变的实际使用条件下或选择有科学依据支持的其他食品模拟
物重新进行迁移试验。
3.6 对于与实际成型品有明显差异的食品接触材料(如树脂或粒料、涂料、油墨、粘合剂等),应当按照
实际加工条件制成成型品(或片材、试样)进行迁移试验,成型品(或片材、试样)的具体要求应当符合
GB 5009.156及其他食品安全国家标准的规定。
3.7 相应食品安全国家标准对于迁移试验有特殊规定时,应符合相应标准的规定。
4 食品模拟物的选择
4.1 食品模拟物选择的一般要求
当食品接触材料及制品预期接触某一类食品(例如酸性食品)时,应选择相应的食品模拟物进行迁
移试验,食品模拟物的选择应符合表1的规定。
4.2 预期接触多种类型材料及制品总迁移量试验的食品模拟物
当食品接触材料及制品预期接触多种类型的食品(例如所有食品类别)时,测定其总迁移量时食品
模拟物的选择应符合表2的规定。
5 迁移试验条件的选择
5.1 特定迁移试验条件
5.1.1 一次性使用的食品接触材料及制品
5.1.1.1 迁移试验条件(时间和温度)应符合表3和表4的规定。
5.1.1.2 食品接触材料及制品连续经历两个或多个使用条件时,应按使用条件顺次选择表3和表4中
的迁移试验时间和温度或有科学依据支持的最严苛的时间和温度组合,用同一份试样进行连续的迁移
试验。
5.1.1.3 用于微波炉加热的食品接触材料及制品的迁移试验,对含油脂食品模拟物应当选择130℃、
15min;对水性食品模拟物应当选择100℃、15min。
5.1.1.4 室温或低于室温条件下贮存30d以上时,可采用升温加速试验进行迁移试验,升温加速试验
条件的选择应符合表5的规定。
5.1.2 重复使用的食品接触材料及制品
5.1.2.1 迁移试验条件应符合5.1.1的规定。
5.1.2.2 对同一件测试样品或其同一试样应进行三次迁移试验,每次均使用一份新的食品模拟物,并以
第三次迁移试验测定结果为依据进行合规性判定。如确有证据证明第一次迁移试验的迁移量未超过迁
移限量且第二次、第三次迁移试验的迁移量不会增加,则不再进行多次迁移试验。
5.1.2.3 对于特定迁移限量不得检出的食品接触物质,应以第一次迁移试验的测定结果为依据进行合
规性判定。
5.2 总迁移试验条件
5.2.1 总迁移试验条件应符合表6的规定。
5.2.2 对不适合采用5.2.1规定的总迁移试验条件的材料及制品,应选择有科学依据支持的、最严苛的
试验条件,具体可依据相应的食品安全国家标准规定的试验条件进行。
5.2.3 对重复使用的食品接触材料及制品按照5.1.2.2执行。
6 筛查试验及化学溶剂替代试验
6.1 总迁移量筛查试验
对于非挥发性物质的特定迁移量,可采用在特定迁移试验同等或更严苛的试验条件下测定的总迁
移量进行估算,当总迁移量小于特定迁移限量时,可不再进行特定迁移量的测定。
6.2 残留量筛查试验
对于某些使用量较少的加工助剂或添加剂,以及在食品或食品模拟物中不稳定的物质或尚无分析
方法的物质等的特定迁移量,可通过测定食品接触材料及制品中该物质的残留量替代特定迁移量进行
估算,当测得的残留量按照相应换算方式折算出的迁移量小于特定迁移限量时,可不再进行特定迁移量
的测定。
6.3 化学溶剂替代试验
6.3.1 对于油脂类食品﹐可采用95%(体积分数)乙醇、正己烷、正庚烷、异辛烷等抽提能力较强的化学
溶剂替代油脂类食品模拟物,测定材料及制品的溶剂抽提量。当溶剂抽提量符合总迁移限量或特定迁
移限量规定时,不再进行油脂类食品模拟物的迁移试验;当抽提量不符合总迁移限量或特定迁移限量规
定时,应进行油脂类食品模拟物的迁移试验,并根据在油脂类食品模拟物中的迁移量进行合规性判定。
6.3.2 化学溶剂替代试验的试验条件,应采用最严苛的、有科学依据支持的、能够最真实地反映实际油
脂类食品或相应食品模拟物迁移状况的试验条件。
7 结果校正
测定结果应当参照附录A的要求,经下列校正因子校正:
b) 含油脂食品模拟物的校正因子;
c) 脂肪校正因子。
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,
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.
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.
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,
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
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
Table A.1 Selection of Food Categories and Corresponding Food Simulants
Food
classification
No.
Food Category
Food simulants a
10%
(volume
fraction)
4%
(volume
fraction)
acetic acid
20%
(volume
fraction)
Ethanol
50% (volume
Ethanol
Vegetable
oil b
01 Beverages
01.01
Non-alcoholic beverages or
alcoholic beverages with
alcohol content ≤10% (volume
fraction)
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
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%
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
Alcoholic beverages or edible
whose alcohol ethanol content
is more than 50% (volume
fraction)
Xc
Ethanol of actual
concentration or
95% of ethanol
substitute
02.01 Starch
02.02
Cereals, including t...
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