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On April 19, 2023, CFSA released the draft of the new version of GB 4806.1-2016 General Safety Requirements for Food Contact Materials and Articles, which is the most fundamental and general standard for food contact materials (FCM) in China, applying to all kinds of FCM. The draft proposes changes to the definitions, basic requirements, compliance principles, and product information. This is the first time that a new version has been proposed since its implementation in 2016. Detailed interpretations are as follows:
1. Definitions
The draft revises the definition of functional barrier as a barrier composed of one or more layers of materials in FCM and articles, which is used to prevent the migration of specific substances on the outer side (non food contact side) into food or food simulants. In this draft, the provision that "the functional barrier must ensure that the mass of unapproved substances transferred to food does not exceed 0.01 mg/kg" in the current version has been removed from the definition to the compliance principle section.
The draft adds the definition of complete barrier as a barrier composed of one or more layers of materials outside FCM and articles, which is used to prevent the migration of all substances on the outer side (non food contact side) into food or food simulants.
2. Basic Information
The draft adds a new requirement for the newly introduced absolute barrier, which clarifies that materials and articles on the outer side of the absolute barrier do not belong to FCM and articles. Manufacturers should ensure the effectiveness of the absolute barrier within its service life.
3. Compliance principle
The draft integrates the content of limit requirements and compliance principles in the current version, and further divides them into two parts: raw material requirements and limit requirements.
(1) Raw material requirements:
Apart from current requirements, the following new requirements are clearly listed in the new draft:
Permitted food raw materials in China can also be used for the production of FCM and articles, under the condition of complying with the corresponding standards and announcements.
Permitted polymer materials such as plastics, rubber, silicone rubber, coatings, adhesives, and inks in China can be blended if chemical reaction will definitely not happen.
Substances that are not listed in the corresponding standards and announcements can be used for the production of FCM and articles on the outer side of the functional barrier. Manufacturers should conduct safety assessments and controls on these substances, ensuring that their specific migration amount does not exceed 0.01 mg/kg and the final product complies with Clauses 3.1 and 3.2. Carcinogenic, teratogenic, mutagenic substances, and nanomaterials are not applicable to the above principles.
(2) Limit requirements:
The draft newly clarifies the compliance requirements for specific substances, and revises the requirements for the maximum usage, maximum residue, residue indicators, and migration limits in composite materials, articles, etc.
For the same substance or substances in the same group that both SML [or SML (T)] and QM are specified, when there is a corresponding migration test method for that substance or that group of substances, the substance(s) should comply with the provisions of SML [or SML (T)]. When there is no migration testing method, either QM or residual screening can be used to verify the compliance. That is to say, for substances that have both a SML and a QM, compliance testing can be conducted for either SML or QM based on the actual situation. However, SML has a higher priority.
Composite materials and articles, combined materials and articles, coating products, and materials mentioned in 4.1.3 of this draft, 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 announcements for different materials are only applicable to such materials. When different materials have the same item with SML, the FCM and articles as a whole should meet the minimum limit value of the item. Except for special cases where different materials have the same item with SML, it is necessary to meet the corresponding SMLs in standards and announcements for different materials.
4. Product information
The product information of FCM and articles is revised and classified into two parts: labeling and declaration of conformity. Product information shall be truthful, accurate, and adequate to ensure sufficient information for the safety assessment and the use of FCM and articles.
The draft stipulates detailed provisions on product labeling and provides clear guidance for relevant manufacturers. It requires manufacturers and distributors to provide a declaration of conformity (excluding products directly provided to consumers), which should include product name, material, national food safety standard code and sequence number the product follows, as well as a list of raw materials with restrictive requirements and their restrictive requirements. When any change happens to factors such as raw materials, ingredients, and production processes that may affect product safety, manufacturers should promptly update their compliance statements.
In a nutshell, compared to the current version, this draft introduces new concept and new requirements regarding China’s FCM supervision, which have significant impacts on the use and production of FCM and articles. If you have any questions about the FCM regulations in China, please feel free to contact us via [email protected] at any time.
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