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GB 9685-2016 (GB9685-2016)

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GB 9685-2016: PDF in English
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
production of food contact materials and their products is expressed in mass fraction (%).
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,
expressed by the quantity of substance (in milligram) migrating from each kilogram of foods
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
decimeter of contact area between food contact materials/their products and foods or food
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
Their Products
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.
3.5 The substances listed in GB 2760, where permitted to be used as additives in food
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
with Their Using Requirements
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
of resin acronyms; specific resin types include those specified in GB 4806.6 and other
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.
A.4 Where the additives listed in this appendix contain metallic elements listed in Table
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...
......
(Above excerpt was released on 2017-06-08, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/GB9685-2016