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食品安全国家标准 食品接触材料及制品用添加剂使用标准
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GB 9685-2016
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标准编号: GB 9685-2016 (GB9685-2016)
中文名称: 食品安全国家标准 食品接触材料及制品用添加剂使用标准
英文名称: National food safety standard -- Standard for uses of additives in food contact materials and their products
行业: 国家标准
中标分类: X09
字数估计: 382,344
发布日期: 2016-10-19
实施日期: 2017-10-19
旧标准 (被替代): GB 9685-2008
标准依据: 国家卫生和计划生育委员会公告2016年第15号
GB 9685-2016: 食品安全国家标准 食品接触材料及制品用添加剂使用标准
GB 9685-2016 英文版: National food safety standard -- Standard for uses of additives in 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用添加剂使用标准
2016-10-19发布
2017-10-19实施
中 华 人 民 共 和 国
国家卫生和计划生育委员会 发 布
前言
本标准代替GB 9685-2008《食品容器、包装材料用添加剂使用卫生标准》。
本标准与GB 9685-2008相比,主要变化如下:
---标准名称修改为“食品安全国家标准 食品接触材料及制品用添加剂使用标准”;
---修订了标准范围的表述;
---修订了部分术语和定义;增加了“特定迁移总量限量”等术语和定义;
---修订了使用原则;
---食品接触材料及制品用添加剂的使用规定中增加了对标准各部分附录的使用说明,删除特定迁移量和检验方法判定的内容;
---调整了附录A的结构,将添加剂名单及其使用要求按照使用范围类别分别列于附录A的表
A.1~表A.7中,列表中增加了FCA号、特定迁移总量限量和特定迁移总量限量分组编号三栏;
---修订了附录A食品接触材料及制品允许使用的添加剂及使用要求,增加了表A.1~表A.7的规定内容;
---附录A中列出的添加剂的品种由958种扩充到1294种;
---增加了原卫生部2012年第5号、2012年第11号、卫生和计划生育委员会2013年第1号、2013
年第14号和2014年第14号公告的食品接触材料及制品用添加剂规定;
---删除了邻苯二甲酸二甲酯等4种邻苯二甲酸酯类物质,并调整了其他邻苯二甲酸酯类物质的使用范围和限制接触的食品类型;
---删除了2种水合物和使用范围为玻璃、金属、陶瓷和搪瓷的食品接触材料及制品用添加剂;
---删除了同时列在GB 2760-2014表A.2中的物质;
---删除了全氟烷基丙烯酸酯共聚物等3种纸中用全氟化合物;
---修订了1,6-己二胺、苯酚等食品接触材料及制品用添加剂的使用范围和限量等规定;
---修订了附录A注中的着色剂纯度要求;
---增加了附录B特定迁移总量限量要求;
---增加了附录C金属元素特别限制规定;
---将附录A的注修订为附录D树脂缩写含义,附录D增加了原卫生部2011年第23号公告批准的树脂通用类别;
---增加了附录E按照CAS号排序和按照中文名称排序的检索目录。
食品安全国家标准
食品接触材料及制品用添加剂使用标准
1 范围
本标准规定了食品接触材料及制品用添加剂的使用原则、允许使用的添加剂品种、使用范围、最大使用量、特定迁移限量或最大残留量、特定迁移总量限量及其他限制性要求。
本标准也包括了食品接触材料及制品加工过程中所使用的部分基础聚合物的单体或聚合反应的其他起始物。
2 术语和定义
2.1 食品接触材料及制品用添加剂
在食品接触材料及制品生产过程中,为满足预期用途,所添加的有助于改善其品质、特性,或辅助改善品质、特性的物质;也包括在食品接触材料及制品生产过程中,所添加的为保证生产过程顺利进行,而不是为了改善终产品品质、特性的加工助剂,以下简称添加剂。
2.2 最大使用量
在生产食品接触材料及制品时所加入的某种或某类添加剂的最大允许量,以质量分数(%)表示。
2.3 最大残留量(QM)
食品接触材料及制品中残留的某种或某类添加剂的最大允许量,以每千克食品接触材料及制品中残留物质的毫克数(mg/kg),或食品接触材料及制品与食品接触的每平方分米面积中残留物质的毫克数(mg/dm2)表示。
2.4 特定迁移限量(SML)
从食品接触材料及制品迁移到与其接触的食品或食品模拟物中的某种或某类添加剂的最大允许量,以每千克食品或食品模拟物中迁移物质的毫克数(mg/kg),或食品接触材料及制品与食品或食品模拟物接触的每平方分米面积中迁移物质的毫克数(mg/dm2)表示。
2.5 特定迁移总量限量[SML(T)]
从食品接触材料及制品中迁移到与其接触的食品或食品模拟物中的两种或两种以上添加剂的最大允许总量,以每千克食品或食品模拟物中指定的某种或某类迁移物质(或基团)的毫克数(mg/kg),或食品接触材料及制品与食品或食品模拟物接触的每平方分米面积中指定的某种或某类迁移物质(或基团)的毫克数(mg/dm2)表示。
2.6 CAS号(chemical abstract service)
化学文摘登记号。
2.7 不得检出(ND)
所分析的目标物质在采用具有规定检出限(detection limit,DL)的分析方法检测时不应被检出。
2.8 FCA号
食品接触材料及制品用添加剂的中国编码。
3 食品接触材料及制品用添加剂的使用原则
3.1 食品接触材料及制品在推荐的使用条件下与食品接触时,迁移到食品中的添加剂及其杂质水平不应危害人体健康。
3.2 食品接触材料及制品在推荐的使用条件下与食品接触时,迁移到食品中的添加剂不应造成食品成分、结构或色香味等性质的改变(有特殊规定的除外)。
3.3 使用的添加剂在达到预期的效果下应尽可能降低在食品接触材料及制品中的用量。
3.4 使用的添加剂应符合相应的质量规格要求。
3.5 列于GB 2760的物质,允许用作食品接触材料及制品用添加剂时,不得对所接触的食品本身产生技术功能。
4 食品接触材料及制品用添加剂的使用规定
4.1 食品接触材料及制品用添加剂的使用应同时符合附录A、附录B和附录C的规定。
4.2 食品接触材料及制品允许使用的添加剂及使用要求见附录A。
4.3 特定迁移总量限量要求参见附录B。
4.4 金属元素特别限制规定见附录C。
4.5 塑料材料缩写含义参见附录D,附录D用于描述各种塑料类材料的缩写含义,仅适用于本标准。
4.6 按照CAS号和音序排序的检索目录见附录E。
附 录 A
食品接触材料及制品允许使用的添加剂及使用要求
A.1 本附录以列表的形式规定了各类食品接触材料及制品中允许使用的添加剂。各表中添加剂按中文名称的字符、数字、英文字母及汉语拼音首字母的音序顺序排序,应同时符合表中各栏的所有规定。
A.2 “最大使用量”一栏规定了添加剂可以应用的最大使用量。表A.1食品接触用塑料材料及制品中允许使用的添加剂及使用要求列表的“最大使用量”一栏还列出了添加剂可以应用的具体塑料树脂类别,以树脂缩写表示。树脂缩写含义见附录D,具体树脂类别包括GB 4806.6涵盖的树脂种类和其他已批准的树脂种类。
A.3 “SML/QM”一栏规定了添加剂的特定迁移限量或最大残留量。“SML(T)”一栏列出了应符合特定迁移总量限量规定的物质以及相应限量。“SML(T)分组编号”一栏列出了表B.1中的SML(T)分组编号。相应添加剂迁移量之和应符合附录B中SML(T)分组编号所对应的特定迁移总量限量的规定。“最大使用量”、“SML”、“QM”和“SML(T)”无限量的情况表示无特别限制。“SML”和“SML(T)”均无限量的情况,添加剂的迁移量不得超过60mg/kg。
A.4 本附录中列出的添加剂如含有表C.1列出的金属元素,其使用应符合表C.1对金属元素特定迁移限量的特别限制规定。
A.5 某些添加剂因异构体的存在或其中成分比例不同等原因可能有一个以上的CAS号。有多种中文名称的同一添加剂,以CAS号为准,没有CAS号的添加剂以中文名称为准。
A.6 表A.1规定了食品接触用塑料材料及制品中允许使用的添加剂的FCA号、中文名称、CAS号、使用范围和最大使用量、SML/QM、SML(T)、SML(T)分组编号与相关限制性要求。
A.7 表A.2规定了食品接触用涂料和涂层中允许使用的添加剂的FCA号、中文名称、CAS号、最大使用量、SML/QM、SML(T)、SML(T)分组编号与相关限制性要求。
A.8 表A.3规定了食品接触用橡胶材料及制品中允许使用的添加剂的FCA号、中文名称、CAS号、最大使用量、SML/QM、SML(T)、SML(T)分组编号与相关限制性要求。
A.9 表A.4规定了食品接触材料及制品用油墨中允许使用的添加剂的FCA号、中文名称、CAS号、最大使用量、SML/QM、SML(T)、SML(T)分组编号与相关限制性要求。
A.10 表A.5规定了食品接触材料及制品用粘合剂中允许使用的添加剂的FCA号、中文名称、CAS号、最大使用量、SML/QM、SML(T)、SML(T)分组编号与相关限制性要求。
A.12 表A.7规定了其他食品接触材料及制品(硅橡胶等)中允许使用的添加剂的使用范围、FCA号、中文名称、CAS号、最大使用量、SML/QM、SML(T)、SML(T)分组编号与相关限制性要求。
A.13 除本附录列出的添加剂外,符合以下规定的物质也允许用作食品接触材料及制品用添加剂:
a) 在不发生化学反应的情况下,表A.1~表A.7中列出的物质的混合物,混合物的使用符合其中所有添加剂的相关规定;
b) 在不对食品本身产生技术功能的情况下,在GB 2760的表A.2中列出的物质,其使用符合本标准的相关要求;
c) 本附录中列出的酸、醇或酚类物质,其钠盐、钾盐和钙盐(包括酸式盐和复盐)也可使用,且符合相应酸、醇或酚类添加剂的限制性要求;本标准已列出的钠盐、钾盐和钙盐(包括酸式盐和复盐),其使用应按本标准规定执行;
d) 本附录中列出的物质的含结晶水物质,其使用符合相应物质的限制性要求;
e) 我国允许用于食品接触材料及制品的分子量大于1000Da的聚合物(微生物发酵生成的大分子物质除外),其使用符合相应聚合物的限制性规定。
表A.1 食品接触用塑料材料及制品中允许使用的添加剂及使用要求
附 录 B
表B.1列出了附录A中特定迁移总量限量所对应的SML(T)分组编号、CAS号、受限物质名称、SML(T)以及限制说明。各组物质按照CAS号由小到大的顺序排序。
表B.1 特定迁移总量限量
附 录 C
金属元素特别限制规定
本标准允许使用的含有表C.1列出的金属元素的物质,其使用还应符合表C.1对金属元素特定迁移限量的特别限制规定;表C.1中列出的金属元素特定迁移限量仅适用于本标准已批准的含有这些金属元素的物质;同时使用两种及以上含有相同金属元素的物质时,该金属元素的迁移量之和应符合表C.1的规定。
表C.1 金属元素特别限制规定
附 录 D
表A.1中各种塑料类材料的缩写含义
附录A的表A.1中各种塑料类材料的缩写含义如表D.1所示。
附 录 E
食品接触材料及制品用添加剂检索目录
表E.1按照CAS号的大小顺序列出了附录A中列出的添加剂的CAS号、中文名称、FCA号及页码。无CAS号的添加剂列于表E.1的最后,按照中文名称的字符、数字、英文字母及汉语拼音首字母的音序顺序排序。表E.2按照中文名称的字符、数字、英文字母及汉语拼音首字母的音序顺序列出了附录A中列出添加剂的中文名称、CAS号、FCA号及页码。
表E.1 按照CAS号排序的食品接触材料及制品用添加剂检索目录
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
National Food Safety Standard
Standard for Uses of Additives in Food
Contact Materials and Their Products
ISSUED ON. OCTOBER19, 2016
IMPLEMENTED ON. OCTOBER 19, 2017
Issued by. National Health and Family Planning Commission of the
People's Republic of China
GB
Foreword
This standard supersedes "Hygienic Standards for Uses of Additives in Food Containers
and Packaging Materials" (GB 9685-2008).
Compared with 9685-2008, the main changes in this standard are as follows.
- The standard name is revised as "National Food Safety Standard - Standard for Uses
of Additives in Food Contact Materials and Their Products";
- The expression of standard scope is revised;
- Some terms and definitions are revised while some, such as "total specific migration
limit", are added;
- The using principles are revised;
- As for the using requirements of additives in food contact materials and their products,
the application instructions for each appendix of this standard are added while the contents
of specific migration and inspection method judgment are deleted;
- The structure of Appendix A is adjusted, the list of additives and their using
requirements are respectively listed in Tables A.1~A.7 in Appendix A; three columns,
namely FAC No., SML (T) and SML (T) Group No., are added;
- Food contact materials and their products - allowable additives with their using
requirements (Appendix A) are revised, and the contents in Tables A.1~A.7 are added;
- Varieties of additives listed in Appendix A are increased from 958 kinds to 1294
kinds;
- The requirements of additives in food contact materials and their products in
Announcements of the former Ministry of Health (No. 5 [2012] and No. 11 [2012]), and
Announcements of the National Health and Family Planning Commission (No. 1 [2013], No.
14 [2013] and No. 14 [2014]) are added;
- 4 kinds of phthalate esters, such as dimethyl phthalate, are deleted, the usage scope of
other phthalate esters and the types of foods they are limited from contact are adjusted;
- 2 kinds of hydrates and the additives in food contact materials and their products with
usage scope of glass, metal, ceramic and enamel are deleted.
- Substances simultaneously listed in Table A.2 of GB 2760-2014 are deleted;
- 3 kinds of perfluorochemicals used in paper, such as perfluoroalkyl acrylate
copolymer, are deleted;
- The requirements for use scope and limit of additives in food contact materials and
their products (such as 1,6-hexanediamine and phenol) are revised;
- The purity requirements for colorant in notes of Appendix A are revised;
- Requirements of total specific migration limit (Appendix B) are added;
- Special limitation of metallic elements (Appendix C) is added;
- The notes of Appendix A are revised as the meanings of resin acronyms in Appendix
D; the universal category of resin approved in the Announcement of the former Ministry of
Health (No. 23 [2011]) is added in Appendix D;
- Search directory ordered according to CAS No. and Chinese name (Appendix E) are
added.
National Food Safety Standard
Standard for Uses of Additives in
Food Contact Materials and Their Products
1 Scope
This standard specifies the using principles of additives in food contact materials and
their products well as the variety, use scope, maximum level, specific migration limit or
maximum residue quantity, total specific migration limit and other limit requirements of
their allowable additives.
This standard also includes monomers of some basic polymers or other initiators of
polyreaction used during the processing of food contact materials and their products.
2 Terms and Definitions
2.1 Additives in food contact materials and their products
The substances added in food contact materials and their products during the
production, which improve or help to improve their quality and characteristics so as to meet
the intended use; they also include the processing agents (hereinafter referred to as
"additive") added in production process so as to ensure the smooth development of
production process other than improving the quality and characteristics of the final products.
2.2 Maximum usage quantity
The maximum allowable quantity of certain kind or type of additive added during the
2.3 Maximum residue quantity (QM)
The maximum allowable quantity of certain kind or type of residue in food contact
materials and their products, expressed by the amount of residue (in milligram) in each
kilogram of food contact materials and their products (mg/kg) or by the amount of residue
(in milligram) in each square decimeter of contact area between food contact materials/their
products and foods (mg/dm2).
2.4 Specific migration limit (SML)
The maximum allowable quantity of certain kind or type of additive migrating from
food contact materials and their products to foods or food simulants contacting them,
or food simulants (mg/kg) or by the quantity of substance (in milligram) migrating from
each square decimeter of contact area between food contact materials/their products and
foods or food simulants (mg/dm2).
2.5 Total specific migration limit [SML (T)]
The total maximum allowable quantity of two or more kinds of additives migrating
from food contact materials and their products to foods or food simulants contacting them,
expressed by the quantity of the specified kind or type of migrated substance (or group) (in
milligram) in each kilogram of foods or food simulants (mg/kg) or by the quantity of the
specified kind or type of migrated substance (or group) (in milligram) in each square
simulants (mg/dm2).
2.6 CAS No. (chemical abstract service)
Chemical Abstract Service Registry Number.
2.7 Not detectable (ND)
The analyzed target substance shall not be detected out where the analysis method with
specified detection limit (DL) is adopted.
2.8 FCA No.
Chinese number of additives in food contact materials and their products.
3 Using Principles of Additives in Food Contact Materials and
3.1 When the food contact materials and their products contact the foods under
recommended use conditions, the level of additive migrating into foods and its impurity
level shall not be harmful to human health.
3.2 When the food contact materials and their products contact the foods under
recommended use conditions, the additive migrating into foods shall not change the
composition, structure or color, aroma, taste, etc. of the foods (unless otherwise specified).
3.3 The quantity of additive used in food contact materials and their products shall be
minimized under the premise of realizing the expected effect.
3.4 The used additive shall meet corresponding quality specification requirements.
contact materials and their products, shall not generate technological function on the foods
they contact.
4 Using Requirements of Additives in Food Contact Materials and
Their Products
4.1 The use of additives in food contact materials and their products shall simultaneously
meet the requirements of Appendixes A, B and C.
4.2 See Appendix A for food contact materials and their products - allowable additives
Appendix A
Food Contact Materials and Their Products - Allowable Additives
A.1 This appendix specifies allowable additives in various food contact materials and their
products in table form. Additives in each table are ordered by the number of characters of
Chinese names, numeric order and phonetic sequence of English alphabets and Chinese
phonetic alphabets; meanwhile, they shall meet all those specified in each column of the
table.
A.2 The column of "maximum level" specifies the allowable maximum level of the
additive. The column "maximum level" in the list of food contact plastic materials and their
products - allowable additives with their using requirements (Table A.1) also lists specific
types of allowable plastic resins (expressed in acronyms). See Appendix D for the meanings
approved ones.
A.3 The column "SML/QM" specifies the specific migration limit or maximum residue
quantity of additive. The column "SML (T)" lists the substances and corresponding limits
which shall meet the requirements of total specific migration limit. The column "SML (T)
Group No." list the SML (T) Group No. in Table B.1. The sum of corresponding additive
migration quantities shall meet the corresponding total specific migration limit of the SML
(T) Group No. in Appendix B. The unlimited "maximum level", "SML", "QM" and "SML
(T)" express that there is no special limitation. Where both "SML" and "SML (T)" are
unlimited, the migration of additive shall not exceed 60mg/kg.
C.1, their use shall meet the special limitation for specific migration limit of metallic
elements as listed in Table C.1.
A.5 Some additives may have more than one CAS No.s due to the existence of isomer or
uncoordinated proportion of ingredients. As for the additive with various English names, the
CAS No. shall prevail; as for the additive without CAS No., the English name shall prevail.
A.6 Table A.1 specifies the FCA No., English name, CAS No., use scope, maximum level,
SML/QM, SML (T), SML (T...
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