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Public solicitation of industry opinions on the draft of the national standard GB 4806.1 for food contact materials


Time:

2023-04-20

The draft of the National Food Safety Standard General Safety Requirements for Food Contact Materials and Products (GB 4806.1) is publicly solicited for industry opinions

Recently, the National Food Safety Risk Assessment Center organized the drafting of the revision of the "National Food Safety Standard General Safety Requirements for Food Contact Materials and Products" (GB 4806.1-2016), and is now soliciting public opinions. The deadline is May 15, 2023.

 

Draft content

1 Scope

This standard specifies the terms and definitions, basic requirements, compliance principles, inspection methods, traceability, and product information of food contact materials and products.
This standard is applicable to various food contact materials and products.

 

2 Terms and definitions

 

2.1 Food contact materials and products
Under normal conditions of use, various materials and products that have come into contact or are expected to come into contact with food or food additives (hereinafter referred to as food), or whose components may be transferred into food, including packaging materials, containers, tools and equipment used in food production, processing, packaging, transportation, storage, sales, and use, as well as ink, adhesives, lubricants, etc. that may come into direct or indirect contact with food. Excluding detergents, disinfectants, and public water supply facilities.
2.2 Composite materials and products
Two or more layers of food contact materials and products composed of different or identical materials through bonding, hot melting, or other methods.
2.3 Composite Materials and Products
Food contact materials and products composed of two or more different materials or materials of the same material, assembled, welded, embedded, etc.
2.4 Total migration volume
The total amount of all non volatile substances transferred from food contact materials and products to food simulants in contact with them, expressed in milligrams (mg/kg) of non volatile substances per kilogram of food simulants, or milligrams (mg/dm2) of non volatile substances transferred out per square decimeter of contact area. The contact materials and products for infant and toddler specific foods are expressed in mg/kg.
2.5 Total Migration Limit (OML)
The maximum allowable amount of all non volatile substances that migrate from food contact materials and products to food simulants in contact with them, expressed in milligrams (mg/kg) of non volatile substances per kilogram of food simulants or milligrams (mg/dm2) of non volatile substances that migrate out per square decimeter of contact area. The contact materials and products for infant and toddler specific foods are expressed in mg/kg.
2.6 Maximum usage
The maximum allowable amount of a substance or class of substances added during the production of food contact materials and products, expressed in mass fraction (%).
2.7 Specific migration volume
The amount of a substance or class of substances that migrate from food contact materials and products to food or food simulants in contact with them, expressed in milligrams (mg/kg) of migrating substances per kilogram of food or food simulants, or milligrams (mg/dm2) of migrating substances per square decimeter of area where food contact materials and products come into contact with food or food simulants
2.8 Specific Migration Limit (SML)
The maximum allowable amount of a substance or class of substances transferred from food contact materials and products to the food or food simulants in contact with them, expressed in milligrams (mg/kg) of migrating substances per kilogram of food or food simulants, or milligrams (mg/dm2) of migrating substances per square decimeter of area where food contact materials and products come into contact with food or food simulants.
2.9 Specific Migration Total
The total amount of two or more substances transferred from food contact materials and products to food or food simulants in contact with them, in milligrams (mg/kg) per kilogram of one or more designated migration substances (or groups) in food or food simulants, The milligrams (mg/dm2) of a certain or a certain type of migrating substance (or group) specified in each square decimeter of the area where food contact materials and products come into contact with food or food simulants.
2.10 Specific Migration Total Limit [SML (T)]
The maximum allowable total amount of two or more substances transferred from food contact materials and products to the food or food simulants in contact with them, in milligrams (mg/kg) of one or more designated migration substances (or groups) per kilogram of food or food simulants, The milligrams (mg/dm2) of a certain or a certain type of migrating substance (or group) specified in each square decimeter of the area where food contact materials and products come into contact with food or food simulants.
2.11 Residues
The amount of certain or certain types of residual substances in food contact materials and products is expressed in milligrams (mg/kg) of residual substances per kilogram of food contact materials and products, or milligrams (mg/dm2) of residual substances per square decimeter of area where food contact materials and products come into contact with food.
2.12 Maximum Residue (QM)
The maximum allowable amount of a certain or certain type of residual substance in food contact materials and products is expressed in milligrams (mg/kg) per kilogram of residual substance in food contact materials and products, or milligrams (mg/dm2) per square centimeter of residual substance in food contact materials and products in contact with food.
2.13 Unintentional addition of substances
Non human added substances contained in food contact materials and products, including impurities brought in by raw and auxiliary materials, decomposition products, pollutants, and residual reaction intermediates during production, operation, and use.
2.14 Effective Barrier Layer
Refers to a barrier composed of one or more layers of materials in food contact materials and products, which is used to prevent the migration of specific substances on the outer side (non food contact side), ensuring that food contact materials and products meet corresponding safety requirements.
2.15 Complete Barrier Layer
Refers to a barrier composed of one or more layers of materials outside food contact materials and products, which is used to prevent the migration of all substances on the outer side (non food contact side), ensuring that all substances on the outer side do not migrate into food or food simulants.

 

3 Basic requirements

3.1 When food contact materials and products come into contact with food under recommended usage conditions, the level of substances that migrate into the food should not pose a threat to human health.
3.2 When food contact materials and products come into contact with food under recommended conditions of use, the substances that migrate into the food should not cause changes in the composition, structure, color, aroma, or other properties of the food, and should not produce technical functions of the food (except for special regulations).
3.3 The amount of substances used in food contact materials and products should be minimized as much as possible, provided that the expected effects can be achieved.
3.4 The substances used in food contact materials and products should meet the corresponding quality specifications.
3.5 Food contact materials and product manufacturers should conduct safety assessments and controls on unintentional added substances in their products to ensure that their migration into food meets the requirements of 3.1 and 3.2 of this standard.
3.6 The production of food contact materials and products should comply with the requirements of national food safety standards such as GB 31603.
3.7 The materials and products on the outer side of the absolute barrier layer do not belong to food contact materials and products. The production enterprise of food contact materials and products should ensure the effectiveness of the absolute barrier layer during its service life.

 

4 Compliance principle

4.1 Raw material requirements
4.1.1 The use of resins and basic raw materials in food contact materials and products should comply with the national food safety standards and/or relevant announcements of the corresponding products; The use of additives should comply with the provisions of GB 9685 and/or relevant announcements.
4.1.2 Food raw materials allowed to be used in China can also be used for the production of food contact materials and products. Relevant raw materials should comply with the relevant national food safety standards and/or relevant announcements.
4.1.3 Polymer polymer materials such as plastics, rubber, silicone rubber, coatings, adhesives, and inks allowed to be used in China can be blended without chemical reactions.
4.1.4 Substances that are not listed in the corresponding national food safety standards and announcements can be used for the production of food contact materials and products outside the effective barrier layer; Food contact materials and product manufacturers should conduct safety assessments and controls on these substances, ensuring that their specific migration does not exceed 0.01 mg/kg and ensuring that the final product complies with the provisions of clauses 3.1 and 3.2 of this standard. Carcinogenic, teratogenic, mutagenic substances, and nanomaterials are not applicable to the above principles. 

4.2 Limit requirements

4.2.1 The total migration amount, specific migration amount, specific migration total amount, and residual amount of food contact materials and products should comply with the provisions of the corresponding national food safety standards for total migration limit, maximum usage amount, specific migration limit, specific migration total amount limit, and maximum residual amount.  
4.2.2 For the same substance (group) listed in both GB 9685 and product standards, the substance (group) in food contact materials and finished products shall comply with the corresponding limit regulations, and the limit shall not be accumulated.  
4.2.3 For the same (group) substance that specifies both SML [or SML (T)] and QM, when there is a corresponding migration test method for that (group) substance, it should comply with the provisions of SML [or SML (T)]; When there is no migration testing method, QM or residual screening can be used to verify compliance with migration.
4.2.4 Composite materials and products, composite materials and products, coating products, as well as various materials and materials in the blend materials and products mentioned in 4.1.3 of this standard, shall comply with the corresponding national food safety standards. The maximum usage, maximum residue, and residue indicators specified in the corresponding national food safety standards and relevant announcements for various materials are only applicable to such materials. When various materials have the same migration limit requirements for the same project, the food contact materials and products as a whole should meet the minimum limit value of the project.

 

5 Inspection methods

5.1 The migration test of food contact materials and products should comply with the provisions of GB 31604.1 and GB 5009.156. When there are special provisions in the national food safety standards for products, the provisions of the product standards shall be followed.
5.2 The determination of food contact materials and related items of products should adopt national standard inspection methods. In the absence of corresponding national standard inspection methods, other inspection methods that have been fully verified by technology can be used.

 

6 Traceability

6.1 Food contact materials and products enterprises should establish a product traceability system to ensure the traceability of food contact materials and products at all stages.
6.2 The traceability system should ensure that information on the source and destination of food contact materials and products, as well as compliance information of related substances or materials, can be obtained.

 

7 Product Information

7.1 Food contact materials and products should have product information, including labels and compliance statements. Product information should be truthful, accurate, and sufficient to ensure sufficient information for safety assessment and use of food contact materials and products.
7.2 Label identification
7.2.1 Food contact materials and products should have label identification, which should comply with the requirements of laws and regulations, national food safety standards, and relevant announcements.
7.2.2 The product label identification should be clear, eye-catching, durable, and easy to identify.  
7.2.3 The product label identification should include the product name, material, production date, name, address, and contact information of the producer and distributor (if any), the national food safety standard code and sequence number followed, and precautions for use.  
7.2.3.1 The product name should reflect the true attributes of the product. When a product name has been specified or used in national standards, industry standards, or relevant announcements, one of the names should be chosen as the product name; When there are no national standards, industry standards, or relevant announcement regulations or names used, names that are not easily misunderstood or confused should be used.  
7.2.3.2 Materials include all major category names and common names. The material should include the names of the major categories of materials used (such as plastic, metal, etc.) and general category aliases (if any). If multiple layers or components are involved, they should be labeled separately. If there are special provisions in the national food safety standards for corresponding products, their provisions shall prevail.
7.2.3.3 Precautions for use should include the restrictions on the use of raw materials or products specified in national food safety standards and relevant announcements, such as the restricted user group, temperature, duration, frequency of use, etc; Products that need to be used within a certain period of time should also be labeled with a safe usage period.
7.2.4 In addition to meeting the above requirements, food contact materials and finished products should also be labeled with "for food contact" or "for food packaging" or similar terms, or labeled with spoon and chopsticks.

7.2.5 The label identification should be prominently located in the smallest sales unit of food contact materials and products.

 

7.3 Declaration of Conformity

7.3.1 Producers and distributors should provide a declaration of conformity (excluding products directly provided to consumers) to demonstrate the product's compliance with national food safety standards and relevant announcements.  
7.3.2 The declaration of conformity should include the product name, material, national food safety standard code and sequence number followed, a list of raw materials with restrictive requirements, and their restrictive requirements.
7.3.2.1 List of substances with restrictive requirements and their restrictive requirements include substances with usage levels, specific migration levels, specific migration amounts, residues, and other restrictive requirements listed in national food safety standards and announcements, as well as a list of substances and restrictive requirements that require further downstream safety assessment and control, such as unintentional additives.
7.3.2.2 When required by regulatory or safety assessments, the declaration of conformity should also include the Chinese name and CAS number (if any) of the raw materials used.
7.3.3 When factors such as product raw materials, ingredients, and production processes that may affect product safety change, food contact materials and product manufacturers should promptly update the compliance statement.

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