general safety requirements for food contact...
TRANSCRIPT
National Standard of the People’s Republic of China
GB 480.1-2016
Issue Date: October 19,2016 Effective on: October 19,2017
Issued by the People's Republic of China
National Health and Family Planning Commission
National Standard for Food Safety
General safety requirements for food contact
materials and articles
(Unofficial translation)
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National Standard for Food Safety
General safety requirements for food contact materials and articles
1 Scope
This standard specifies the basic requirements, limit requirements, compliance principles, test methods,
traceability and product information for food contact materials and articles.
2 Terms and definitions
2.1 Food contact materials and articles
Various materials and articles, under the normal condition of uses, that are already or expected to be in
contact with Food and Food Additives (collectively called “food” in following), or their components may
transfer into food, including the packaging materials, containers tools and equipment used during the
manufacturing, processing, packaging, transportation, storage, retailing and use of food, and the printing
inks, adhesive and lubricants etc that may directly or indirect contact food. Detergents, disinfectants and
facility for public plumbing of water are not included.
2.2 Composite material and articles
Two or more layers of food contact materials and articles composed from different or identical materials
through bonding, thermal melting or other methods.
2.3 Combined material and articles
Food contact materials and products made up of two or more types of different or identical materials
through assembling, welding, inlay, etc.
2.4 Overall migration
The total quantity of non-volatile substances that migrate from Food Contact Materials & Articles into
food simulants that are in contact with them, expressed as milligram of non-volatile substances migrated
from Food Contact Materials & Articles into per kilogram of food simulants (mg/Kg) or milligram of non-
volatile substances migrated from Food Contact Materials & Articles per sq decimeter of contact surface
(mg/dm2). For Food Contact Materials & Articles designated for baby use, expressed as mg/Kg.
2.5 Overall migration limit (OML)
The total quantity of non-volatile substances allowed to migrate from Food Contact Materials & Articles
into food simulants that are in contact with them, expressed as milligram of non-volatile substances migrated
from Food Contact Materials & Articles into per kilogram of food simulants (mg/Kg) or milligram of non-
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volatile substances allowed to migrate from Food Contact Materials & Articles per sq decimeter of contact
surface (mg/dm2). For Food Contact Materials & Articles designated for baby use, expressed as mg/Kg.
2.6 Maximum Dosage
The maximum quantity that a specific kind or type of substance can be added in the production of food
contact materials and articles, expressed as mass fraction (%).
2.7 Specific migration
The quantity of a specific kind or type of substance that migrate into food or food simulants that will be
in contact with food contact materials and articles, expressed as milligram substance migrated from Food
Contact Materials & Articles into per kilogram of food simulants (mg/Kg) or milligram substance migrated
from Food Contact Materials & Articles per sq decimeter of surface area in contact with food or food
simulants (mg/dm2). For Food Contact Materials & Articles designated for baby use, expressed as mg/Kg.
2.8 Specific migration limit (SML)
The quantity of a specific kind or type of substance allowed to migrate into food or food simulants that
will be in contact with food contact materials and articles, expressed as milligram substance migrated from
Food Contact Materials & Articles into per kilogram of food simulants (mg/Kg) or milligram substance
migrated from Food Contact Materials & Articles per sq decimeter of surface area in contact with food or
food simulants (mg/dm2).
2.9 Total specific migration
The total quantities of two or more additives that migrate into food or food simulants that will be in
contact with the food contact materials and articles, is expressed as a milligram of specific kind or type of
the migrating substances (or functional groups) per kilogram of food or food simulants (mg/Kg), or
expressed as a milligram of specific kind or type of the migrating substances (or functional groups) per
square decimeter of the surface area of the food contact materials and articles in contact with food or food
simulants.
2.10 Total Specific migration limit (SML(T))
The maximum quantities of two or more additives that are allowed to migrate into food or food simulants
that will be in contact with the food contact materials and articles, is expressed as a milligram of specific
kind or type of the migrating substances (or functional groups) per kilogram of food or food simulants
(mg/Kg), or expressed as a milligram of specific kind or type of the migrating substances (or functional
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groups) per square decimeter of the surface area of the food contact materials and articles in contact with
food or food simulants.
2.11 Residual Quantity
The quantity of a specific kind or type of substance present as residual in Food Contact Materials &
Articles, expressed as milligram of residual substance per kilogram of Food Contact Materials & Articles
(mg/Kg) or milligram of residual substance per sq decimeter of surface area in contact with food or food
simulants (mg/dm2).
2.12 Maximum Residual Quantity (QM)
The total quantity of a specific kind or type of substance allowed to be present as residual in Food
Contact Materials & Articles, expressed as milligram of residual substance per kilogram of Food Contact
Materials & Articles (mg/Kg) or milligram of residual substance per sq decimeter of surface area in contact
with food or food simulants (mg/dm2).
2.13 Non-intentionally added substances
Substances not intentionally added into the Food Contact Materials & Articles, including impurities
brought in from raw-materials, decomposition products, contaminants and residuals from reactive
intermediates produced during manufacturing, marketing and use
2.14 Functional barrier layer
A barrier composed of one or multiple layers of materials in food contact materials and articles, which
is used to prevent the substances behind the barrier from migrating into foods and to ensure the quantity of
unapproved substances migrated into foods doesn’t exceed 0.01 mg/kg and the use of the food contact
materials and articles under the recommended application conditions in compliance with the requirements
of 3.1 and 3.2 of this standard.
3 Basic requirements
3.1. amount of substances migrated from Food Contact Materials & Articles into food should not cause
harm to human health.
3.2. amount of substances migrated from Food Contact Materials & Articles into food should not cause
change to the composition, structure or organoleptic changes, and not give technical function in the
food (unless under special requirement).
3.3. Dosage of substances in Food Contact Materials & Articles should be minimized to get the intended
effects.
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3.4. Substances used in Food Contact Materials & Articles should comply with relevant quality
specification requirement.
3.5. manufacturers of Food Contact Materials & Articles should perform control of NIAS in their product,
so that their migration into food complies with 3.1 and 3.2
3.6. substances not in direct contact with food and have an effective functional barrier, and not listed in
the food safety standards, manufacturers of Food Contact Materials & Articles should perform risk
assessment and control to ensure their migration not exceeding 0.01mg/kg. The above are not
applicable to Carcinogenic, Mutagenic and Reproductive Toxic substances and Nano materials not
acceptable.
3.7. Production of Food Contact Materials & Articles should comply with the requirement of GB31603.
4 Limit requirements
4.1 General requirements
The total migration limit, substance dosage, specific migration limit, total specific migration limit,
maximum residual, etc. of food contact materials and articles shall comply with the provisions of the
relevant national food safety standards for total migration limit, maximum dosage, specific migration
limit, total specific migration limit, maximum residual quantity etc.
4.2 Special requirements
4.2.1 The same (group of) substance(s) listed in both GB9685 and the product standard in food contact
materials and articles shall comply with the provisions on relevant limits, and the limit values shall not be
added up.
4.2.2 Various materials in composite materials and their articles, composite materials and their articles
and coating products shall comply with the provisions of the relevant national food safety standards.
When various materials have the same limit item, food contact materials and articles shall comply with
the weighted average value of the corresponding limit for that item. When the weighted average cannot be
calculated, the minimum limit value of that item should be used.
5 Principle for compliance with standards
5.1 The use of raw materials in food contact materials and products shall comply with the provisions of
the national food safety standards of the corresponding articles and relevant announcements.
5.2 The use of additives in food contact materials and products shall comply with the provisions of GB
9685 and relevant announcements.
5.3 The food contact materials and products shall comply with the provisions of the national food safety
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standards of corresponding product.
6 Test methods
6.1 The migration test of food contact materials and articles shall be in accordance with the provisions
of GB 31604.1 and GB 5009.156. When there are specific provisions for the product in national food safety
standard, the provisions of the product standards shall apply.
6.2 National standard test methods shall be used for related test items for food contact materials and
articles; where no corresponding national standard test methods exist, other test methods with sufficient
technical verification can be used.
7 Traceability
7.1 The manufacturers of food contact materials and articles shall establish product traceability systems
to ensure the traceability in all the stages.
7.2 The traceability system shall be such as to ensure that the information on the source and destination of
food contact materials and articles and the regulatory compliance information on relevant substances
or materials can be obtained.
8 Product information
8.1. Production identification information shall be clear and true and shall not mislead users.
8.2. Product should provide necessary product information, including Product Identification label, technical
information etc., and declaration of compliance, to ensure enough information for safety assessment of
the Food Contact Materials & Articles.
8.3. Product Identification should include product name, material type, declaration of compliance of relevant
standards, name, address and contact details of manufacturer and/or seller, date of manufacture and shelf
life (when relevant) etc. content.
8.4. Declaration of compliance should include the applicable regulations and standards that are in compliance,
name list of substances which contains limitation/restriction, limitation/restrictions, and overall migration
testing results (for final article only) etc.
8.5. Final articles should carry a sign or wording to show that these are “for food contact” applications.
8.6. The above mentioned Product Identification should preferably put on the product or label, the label should
be located in the easily visible area of the smallest selling unit. When it is not possible to put all information
on the product or label due to technical reasons, can show on the product leaflet or accompanying
documents.
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