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标准编号: GB 31604.8-2021 (GB31604.8-2021)
中文名称:
英文名称: Methods of analysis for the evaporated rasidues in the hygienic standard of food containers of plant fibre origin
行业: 国家标准
字数估计: 18,158
发布日期: 2021-09-07
实施日期: 2022-03-07
发布机构: 中华人民共和国国家卫生健康委员会、国家市场监督管理总局

GB 31604.8-2021: 食品安全国家标准 食品接触材料及制品 总迁移量的测定
GB 31604.8-2021 英文名称: Food safety national standard - Food contact materials and products - Determination of total migration
1 范围
本标准规定了食品接触材料及制品总迁移量的测定方法。
本标准适用于食品接触材料及制品总迁移量的测定。
第一部分 水基食品模拟物、化学替代溶剂中总迁移量的测定
2 原理
试样采用水基食品模拟物、化学替代溶剂[如正己烷、异辛烷、95%(体积分数)乙醇溶液、正庚烷],
在选定的迁移试验条件下进行迁移试验,将迁移试验所得浸泡液蒸发并干燥后,扣除相应空白得到试样
向水基食品模拟物、化学替代溶剂迁移的所有非挥发性物质的总量。
3 试剂和材料
除非另有说明,本方法所用试剂均为分析纯,水为GB/T 6682规定的二级水。
3.1 试剂
3.1.1 无水乙醇(C2H6O)。
3.1.2 乙酸(C2H4O2)。
3.1.3 三氯甲烷(CHCl3)。
3.1.4 正己烷(C6H14)。
3.1.5 异辛烷(C8H18)。
3.1.6 95%乙醇。
3.1.7 正庚烷(C7H16)。
3.2 试剂配制
水基食品模拟物的配制:GB 31604.1中水性食品或酒精饮料所对应的4%(体积分数)乙酸溶液、
10%(体积分数)乙醇溶液、20%(体积分数)乙醇溶液、50%(体积分数)乙醇溶液的配制按GB 5009.156操作。
3.3 材料
3.3.1 蒸发皿:玻璃或陶瓷,50mL~250mL。
3.3.2 玻璃干燥器:配有硅胶或无水氯化钙等干燥剂。
3.3.3 滤纸:定性滤纸,快速。
3.3.4 无尘擦拭纸。
4 仪器和设备
4.1 天平:感量为0.1mg。
4.2 电热恒温干燥箱。
4.3 电热恒温水浴锅或其他电热设备。
5 分析步骤
5.1 迁移试验
食品接触材料及制品按照GB 31604.1和GB 5009.156的要求进行迁移试验。
5.2 水基食品模拟物、化学替代溶剂总迁移量的测定
蒸发皿在使用前,洗净并沥干水分,在100℃±5℃电热恒温干燥箱中烘干2h,然后在干燥器中冷
却0.5h后称重,重复烘干、冷却、称重,直至恒重(即前后两次称量质量差不超过0.5mg),最后一次称
量的质量即为空蒸发皿的质量。
取已恒重的空蒸发皿,向其中加入迁移试验所得浸泡液200mL(若蒸发皿规格低于200mL,则需
分次蒸干),置于不高于各浸泡液沸点温度10℃的水浴上蒸干,将蒸发皿底的水滴用滤纸或无尘擦拭纸
吸去(蒸发皿底不得残留纸纤维),再将蒸发皿置于100℃±5℃电热恒温干燥箱中干燥2h后取出,在
干燥器中冷却0.5h后称量,重复烘干、冷却、称重,直至恒重,最后一次称量的质量即为带有试样蒸发
残渣的蒸发皿质量。带有试样蒸发残渣的蒸发皿质量减去空蒸发皿的质量即为试样测定用浸泡液残渣的质量。
5.3 三氯甲烷提取物的测定
本测定步骤适用于产品标准中规定需检测三氯甲烷提取物的食品接触材料及制品。
向5.2所得残渣中加入三氯甲烷20mL,润湿残渣,用滤纸过滤,将滤液收集到已恒重的蒸发皿中,
再分别用20mL三氯甲烷对残渣提取两次。然后用少许三氯甲烷冲洗滤纸,滤液并入蒸发皿中,按5.2
步骤蒸干,获得试样测定用浸泡液经三氯甲烷提取的残渣质量。
5.4 空白试验
按5.1、5.2、5.3处理未与食品接触材料及制品接触的水基食品模拟物、化学替代溶剂、三氯甲烷,得
到空白浸泡液的残渣质量、空白浸泡液经三氯甲烷提取的残渣质量。
6 分析结果的表述
6.1 总迁移量计算
6.1.1 以mg/dm2 表示
6.1.1.1 非密封制品类食品接触材料及制品
除盖子、垫圈、连接件等密封制品(以下简称密封制品)以外的食品接触材料及制品,总迁移量结果
以mg/dm2 表示时,按式(1)计算。
6.1.1.2 密封制品类食品接触材料及制品
密封制品类食品接触材料及制品的总迁移量结果以mg/dm2 表示时,按式(2)计算。
6.1.2 以mg/kg表示
6.1.2.1 非密封制品类食品接触材料及制品
非密封制品类食品接触材料及制品的总迁移量结果以mg/kg表示时,按式(3)计算。
6.1.2.2 密封制品类食品接触材料及制品
密封制品类食品接触材料及制品的总迁移量结果以mg/kg表示时,按式(4)计算。
6.1.3 以mg/件表示
密封制品总迁移量结果以mg/件表示,按式(5)计算,需注明采用的迁移试验方法及迁移试验中单
个密封制品与食品模拟物接触的面积。
6.2 经三氯甲烷提取后的总迁移量计算
6.2.1 以mg/dm2 表示
经三氯甲烷提取后的总迁移量以mg/dm2 表示时,按式(6)计算。
6.2.2 以mg/kg表示
经三氯甲烷提取后的总迁移量以mg/kg表示时,按式(7)计算。
6.3 结果的校正
当GB 31604.1规定了含油脂食品模拟物校正因子时,化学溶剂替代试验的测定结果均应除以相应
的校正因子。
6.4 结果的表示
总迁移量计算结果以重复性条件下获得的两次平行测定结果的算术平均值表示,计算结果精确到
小数点后一位。
7 精密度
算术平均值的差值不得超过1.0mg/dm2 或6.0mg/kg,应用校正因子后的测定结果也应满足此要求。
当总迁移量结果 >10.0mg/dm2 或60.0mg/kg时,在重复性条件下获得的两次独立测定结果与其
算术平均值的差值不得超过算术平均值的10%,应用校正因子后的测定结果也应满足此要求。
8 原理
试样以橄榄油为食品模拟物,在选定的条件下进行迁移试验。总迁移量的测定采用试样质量减量
法测定,即用试样在迁移试验前的初始质量减去试样经橄榄油浸泡后的净质量,得到试样迁移出的非挥
发性物质的质量,根据公式计算得到相应的总迁移量。试样经橄榄油浸泡后的净质量为试样从橄榄油
中取出时的质量减去试样吸收的橄榄油质量加上挥发物质量,其中试样吸收的橄榄油经索氏萃取器萃
取、皂化、甲酯化后生成脂肪酸甲酯,用气相色谱分析,内标法定量。
除非另有说明,本方法所用试剂均为分析纯,水为GB/T 6682规定的二级水。
9.1 试剂
9.1.1 橄榄油:其质量要求应符合GB 5009.156附录A的规定。
9.1.2 正戊烷(C5H12)。
9.1.3 无水乙醇(C2H6O)。
9.1.4 正庚烷(C7H16):色谱纯。
9.1.5 环己烷(C6H12)。
9.1.6 无水硫酸钠(Na2SO4)。
9.1.7 乙醚(C4H10O)。
9.1.9 甲醇(CH4O)。
9.1.10 三氟化硼甲醇溶液:约150g/L三氟化硼(BF3)。
9.1.11 硫酸(H2SO4)。
9.2 试剂配制
9.2.1 正戊烷-乙醇(95+5)混合溶液:量取950mL正戊烷,与50mL无水乙醇混匀。
9.2.2 氢氧化钾-甲醇溶液(11.0g/L):称取5.5g(精确到0.1g)氢氧化钾,溶于500mL甲醇中,混匀。
9.2.3 饱和硫酸钠溶液:称取50g(精确到0.1g)无水硫酸钠置于250mL烧杯中,加入100mL水于电
热板上加热煮沸溶解,冷却至室温后,用装有定性滤纸的漏斗过滤到烧杯中。
9.2.4 硫酸溶液(430g/L):称取215g(精确到0.1g)硫酸,缓慢加到盛有约300mL水的烧杯中,边加
容量瓶中,用水定容。临用现配。在温度为20℃±5℃时,此溶液置于密闭水分含量调节容器中,保持
相对湿度为50%±5%的水分含量调节环境。
9.2.5 硫酸溶液(70g/L):称取35g(精确到0.1g)硫酸,缓慢加到盛有约300mL水的烧杯中,边加边
搅拌,待溶液冷却到室温后,转移到500mL容量瓶中,用少量水洗涤烧杯2次~3次,合并洗涤液到容
量瓶中,用水定容。临用现配。在温度为20℃±5℃时,此溶液置于密闭水分含量调节容器中,保持相
对湿度为80%±5%的水分含量调节环境。
9.3 标准品
十七烷酸甘油三酯(C54H104O6,CAS号:2438-40-6):纯度≥98%,或经国家认证并授予标准物质证
书的标准物质。
9.4.1 内标溶液(2.0mg/mL)
准确称取1.0g(精确到0.1mg)十七烷酸甘油三酯,置于100mL烧杯中,加入环己烷溶解,移入
500mL容量瓶中,用环己烷洗涤烧杯3次,洗涤液合并入容量瓶中,用环己烷定容。在4℃冰箱中保
存,有效期1个月。
9.4.2 橄榄油标准储备液(100mg/mL)
称取迁移试验所得空白橄榄油5.0g(精确到0.1mg),置于50mL烧杯中,加入正庚烷溶解,移入
50mL容量瓶中,用正庚烷洗涤烧杯3次,洗涤液合并入容量瓶中,用正庚烷定容。临用现配。
9.5 材料
9.5.1 电热板。
9.5.3 滤膜:有机相,0.22μm。
9.5.4 滤纸:定性滤纸,快速。
9.5.5 无尘擦拭纸。
9.5.6 玻璃纤维滤筒。
10 仪器和设备
10.1 气相色谱:配有氢火焰离子化检测器(FID)。
10.2 分析天平:感量0.1mg、0.1g。
10.3 索氏萃取器。
10.4 低温循环冷凝泵。
10.6 旋转蒸发仪。
10.7 真空干燥箱。
10.8 恒温恒湿箱。
11 分析步骤
11.1 试样制备
食品接触材料及制品按GB 31604.1和GB 5009.156的要求进行迁移试验试样制备。全浸没法、填
充法试样制备面积应≥1dm2,测试池法中试样面积以试样实际接触食品模拟物的面积计算,袋装法试
样制备面积应≥2dm2,每份试样可由多个制品制备。试样数量根据以下用途确定:
a) 迁移试验:一次性使用制品至少3份试样;重复使用制品每组试样至少3份试样;
c) 适宜性判定(见附录A):2份试样;
d) 表面积测定:1份试样;
e) 水分敏感性确认:2份试样。
​​​​


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
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
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
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
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
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
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
electric hot plate and boil to dissolve. After cooling to room temperature, use a
funnel equipped with qualitative filter paper to filter into a breaker.
9.2.4 Sulfuric acid solution (430g/L): Weigh 215g (accurate to 0.1g) of sulfuric
acid. Add slowly to a beaker containing about 300mL of water. Stir while adding.
After the solution has cooled to room temperature, transfer to a 500mL
volumetric flask. Wash the beaker with a small amount of water 2 to 3 times.
Combine the washing liquid into the volumetric flask. Use water to set volume.
Prepare it when it is required. When the temperature is 20°C±5°C, the solution
is placed in a closed moisture content adjustment container. Maintain a
9.2.5 Sulfuric acid solution (70g/L): Weigh 35g (accurate to 0.1g) of sulfuric acid.
Add slowly to a beaker containing about 300mL of water. Stir while adding. After
the solution is cooled to room temperature, transfer to a 500mL volumetric flask.
Wash the beaker with a small amount of water 2 to 3 times. Combine the
washing liquid into the volumetric flask. Use water to set volume. Prepare it
when it is required. When the temperature is 20°C±5°C, the solution is placed
in a closed moisture content adjustment container. Maintain a moisture content
adjustment environment with a relative humidity of 80% ± 5%.
9.3 Standard product
≥98%, or standard material certified by the country and awarded with a standard
material certificate.
9.4 Preparation of standard solution
9.4.1 Internal standard solution (2.0mg/mL)
Accurately weigh 1.0g (accurate to 0.1mg) of heptadecanoic acid triglyceride.
Place in a 100mL beaker. Add cyclohexane to dissolve. Transfer to a 500mL
volumetric flask. Wash the beaker 3 times with cyclohexane. The washing liquid
is combined into the volumetric flask. Use cyclohexane to set volume. Store in
a refrigerator at 4°C. The validity period is 1 month.
Weigh 5.0g of blank olive oil obtained from migration test (accurate to 0.1mg).
Place in a 50mL beaker. Add n-heptane to dissolve. Transfer to a 50mL
volumetric flask. Wash the beaker 3 times with n-heptane. The washing liquid
multiple products. The number of specimens is determined according to the
following purposes:
a) Migration test: At least 3 specimens of disposable products; At least 3
specimens per set of specimens for repeated use of articles;
b) Volatile matter determination: 2 specimens;
c) Suitability judgment (see Annex A): 2 specimens;
e) Confirmation of moisture sensitivity: 2 specimens.
11.2 Suitability Judgment
Take 2 specimens to determine the suitability of the method according to the
steps described in Annex A. If the previous test has confirmed the suitability of
the method, it can omit the steps in Annex A.
11.3 Weighing of the initial mass of the specimen
Determine whether the specimen is moisture sensitive according to the steps
described in Annex B or Annex C. If the previous test has confirmed that the
specimen is a non-moisture-sensitive specimen, it can omit the steps in Annex
If the specimen is a non-moisture sensitive specimen, directly weigh the initial
mass. If the specimen is moisture sensitive, after adjusting the moisture content
according to the steps described in the relevant appendix, the initial mass of
the specimen is obtained. If the specimen adopts the steps described in Annex
C to adjust the moisture content and cannot reach a constant weight within 5d,
use Annex B to adjust the moisture content.
11.4 Migration test
The migration test of food contact materials and articles shall be conducted in
accordance with the requirements of GB 31604.1 and GB 5009.156. For
test specimens. Each group of specimens differs only in the migration test time.
The migration test time of the first group of specimens is the migration test time
determined according to the requirements of relevant standards. The migration
test time of the second group of specimens is twice that of the first group. The
migration test time of the third group of specimens is 3 times that of the first
group. The number of parallel specimens for migration test should meet the
requirements of 11.1a).
11.5 Weighing the final mass of the specimen
Remove the specimen from the olive oil as soon as possible after the migration
   
相关标准:  GB 31604.1-2023  GB 31604.7-2023
 
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