China Food Contact Materials Regulatory Guide

1. China’s Food Contact Materials (FCM) Regulatory System

1.1 Definitions and Scope

According to the National Food Safety Standard: General Safety Requirements for Food Contact Materials and Articles (GB 4806.1-2016), Food Contact Materials (FCMs) refer to materials and articles that, under normal use conditions, are already or may come into contact with food or food additives, or whose components may migrate into food. This includes packaging materials, containers, tools, and equipment used in food production, processing, packaging, transportation, storage, sales, and consumption, as well as inks, adhesives, lubricants, etc., that may directly or indirectly contact food. Exclusions include detergents, disinfectants, and public water supply facilities.

1.2 Competent Authorities and Regulatory Model

Competent Authorities:

• National Health Commission (NHC): Responsible for formulating national food safety standards.
• State Administration for Market Regulation (SAMR): Oversees market supervision, sampling inspections, and penalties for non-compliance.
• General Administration of Customs (GAC): Manages supervision and inspection of imported/exported food-related products.

Regulatory Model:

The NHC formulates, updates, and issues national food safety standards for FCMs, implements risk management, and evaluates/approves new varieties of food-related products (e.g., new resins or additives for food contact). Its subordinate agency, the China National Center for Food Safety Risk Assessment (CFSA), conducts technical reviews for new FCM substances, including physicochemical testing, migration studies, and toxicological safety assessments.

Post-market supervision requires enterprises to ensure compliance through declarations of conformity and periodic sampling inspections.

1.3 Regulatory Framework

China’s FCM regulatory system centers on the Food Safety Law and includes four categories of standards:

• Basic Standards: e.g., GB 4806.1-2016 (General Safety Requirements) and GB 9685-2016 (Standards for Use of Additives).
• Product Standards: Material-specific GB 4806 series standards (e.g., GB 4806.7-2023 for plastic products).
• Testing Method Standards: Migration testing, residue determination, etc. (e.g., GB 31604 series).
• Production Practice Standards: GB 31603-2015 (General Health Code for Production), requiring enterprises to establish quality management systems.
• Positive List Substances: Approved substances under GB 9685-2016 Table A, GB 4806.7-2023 Tables A.1, GB 4806.15-2024 Tables A/B, and NHC-announced materials.

2. Application for New Food Contact Substances

2.1 What are considered new food contact materials?

a. Food contact materials not yet listed in the following national food safety standards or related announcements

• GB 9685-2016 'National Food Safety Standard for Uses of Additives in Food Contact Materials and Products';
• Product standards (e.g., GB 4806.7-2023 'National Food Safety Standard for Plastic Materials and Products in Contact with Food');
• New food contact materials approved by announcements from the National Health Commission.

b. Resins and additives already listed in national standards or related announcements but requiring expanded usage scope or quantity.

2.2 Approval Types for New Food Contact Materials

• New types of additives for food contact materials and products;
• New types of resins for food contact materials and products;
• Additives for food contact materials and products with expanded usage scope or quantity;
• Resins for food contact materials and products with expanded usage scope or quantity;
• New types of food contact materials and products.

Examples of application types:

If the product is intended for use in rubber materials and products, PVC plastic materials and products, or added at 0.6% in PVC plastic materials and products, these three scenarios are applicable for applying for expanded usage or quantity.

2.3 Basic requirements for the declaration of new substances in food contact materials

• Clear purpose with technical necessity;
• No harm to human health under normal and reasonable use;
• No alteration to the composition, structure, or sensory properties of food;
• Minimize usage while achieving the desired effect.

2.4 Declaration process

• Pre-assessment: Initial determination of whether the substance needs to be declared and the feasibility of declaration.
• Data integration and experimental testing: Conduct migration tests, quality specification tests, and toxicological tests (if required).
• Dossier preparation and application submission: Organize and compile the declaration materials into a dossier and submit the application dossier to the National Health Commission.

After the applicant provides complete materials, CFSA organizes experts for technical review, and the technical review results will be provided within 60 working days. After completing the technical review, it is usually divided into the following situations:

1. The first is a review extension, indicating that the submitted materials need to be supplemented, and the applicant needs to supplement materials based on the expert's correction opinions. Of course, after submitting the supplementary materials, the expert group needs additional time for further review.
2. The second is a recommendation for approval, at which point CFSA will issue a notice to solicit public comments.
3. The third is a recommendation for disapproval, with reasons for not approving provided.

• Technical review: The expert committee evaluates toxicological data, migration test results, and production processes.
• Approval and announcement: Once approved, it will be included in the permitted list and announced on the official website.

2.5 Declaration materials

Declaration of new additives/new resins:

Mandatory: Items 1-10 (as shown in the table below), where 'information on usage scope, usage quantity, etc.' is only for additives;

If it is the first import, add two additional documents: Certificate of Free Sale and GMP Certificate.

Declaration for Expanding the Scope or Quantity of Use:

Compared to regular declarations, preliminary preparations are simplified; items 2, 4, and 5 can be omitted (as shown in the table below).

3.Corporate Compliance Obligations

3.1 Declaration of Conformity (DOC)

According to the 'National Food Safety Standard-General Safety Requirements on Food Contact Materials and Articles' (GB 4806.1-2016), the Declaration of Conformity (DOC) is a formal document provided by manufacturers, importers, or suppliers of food contact materials and articles to downstream supply chain entities (such as customers, regulatory agencies), declaring that their products comply with relevant Chinese national food safety standards. It is the core proof document for enterprises to fulfill compliance obligations and the primary basis for review during spot checks by the State Administration for Market Regulation (SAMR).

• Enterprises need to pass the Declaration of Conformity downstream, clearly stating that the product complies with relevant national standards, including requirements for raw materials, additives, migration limits, etc.
• The declaration content must cover material composition, test results, usage conditions, and safety assessment conclusions.
• Substances/materials requiring a DOC: For substances already listed in the national standard catalog, such as Table A of GB 9685-2016, Table A.1 of GB 4806.7-2023, Table A or Table B of GB 4806.15-2024; substances approved by the National Health Commission.

3.2 Supply Chain Responsibility Management

In the food contact material supply chain, the main categories of goods passed between upstream and downstream entities are chemical substances, intermediate materials, final materials, or finished products (end products). Therefore, we have outlined the food contact material supply chain as shown in the figure below.

Chemical producer: Chemicals refer to the basic chemical components used in the production of food contact materials and articles, such as additives, solvents, auxiliaries, colorants, etc., excluding monomers or starting materials. The operators of chemical substance production enterprises are chemical producers, who produce in accordance with the applicable provisions of GB 31603 'National Food Safety Standard-General Health Code for Production of Food-contacted Materials and Products' and provide conformity declaration documents for chemical substances, explaining the authorization and usage restrictions of their products in food contact materials, ensuring that the quality specifications of chemical substances meet the requirements for producing food contact materials.

Intermediate Material Producer: Intermediate materials are those that require further processing and reshaping to produce the final product, such as base resins, masterbatches, pre-mixes, bottle preforms, semi-finished films/sheets, and uncompressed plastic layers in composite materials. The operators of intermediate material production enterprises are intermediate material producers, who are responsible for the substances/materials used/added and generated during the product production process, ensuring that the materials and substances comply with regulatory requirements, requesting compliance declarations from upstream, and producing in accordance with GB 31603, the relevant requirements in the compliance declaration, and related food contact material safety standards. Based on the compliance declaration documents provided by upstream and the safety analysis of their own production processes, they provide compliance declarations to downstream customers, explaining the compliance and restriction requirements of materials and additives to ensure the compliance of the final product.

End-Product Manufacturer: End-products are those that can directly contact food but have not yet contacted food. The manufacturers of end-product production enterprises are end-product manufacturers, who are responsible for the raw materials, intermediate materials, added substances, and generated substances used in the production process, ensuring their compliance with regulatory requirements, requesting compliance declarations from upstream, and producing in accordance with GB 31603 and the relevant requirements in the compliance declaration and related food contact material safety standards. Based on the compliance declaration documents provided by upstream and the safety analysis of their own production processes, they provide compliance declarations to downstream customers according to the intended use of the product and retain supporting documents for the compliance declarations.

End-Product User: Refers to the enterprise operators or individuals who use end-products to contact food or food raw materials/semi-finished products. They should request compliance declarations from upstream to ensure that the food contact materials used comply with regulatory requirements and are used correctly (e.g., packaging suitable for specific foods/food types, packaging temperature, time, etc.).

Marketer: Marketers include importers, wholesalers, and retailers. Distributors should store and transport food contact materials according to supplier requirements, and all distributors, except final product retailers, must pass compliance declarations to their direct customers.

Consumer: Individual consumers who purchase food, final products, or packaged food from retailers. Consumers should follow the labels or usage instructions on the product packaging and use the product correctly, especially the restrictive usage requirements such as the food or food category in contact, the time and temperature of contact with food, etc.

3.3 Labeling and Identification Requirements

The identification content should include the product name, material, compliance declaration with relevant regulations and standards, the name, address, and contact information of the producer and/or distributor, production date, and shelf life (when applicable).

In addition to meeting the aforementioned requirements, food contact materials and finished products should also be labeled with terms such as 'for food contact,' 'for food packaging,' or similar phrases, or be imprinted or affixed with the spoon and chopsticks symbol (as shown in Figure A.1), except for products with a clear food contact purpose (such as chopsticks, frying pans, etc.). Products with special usage requirements should indicate the method of use, precautions, intended use, usage environment, and temperature. For products where the usage conditions are explicitly specified by relevant standards or where exceeding the usage conditions may pose a higher food safety risk, the usage conditions should be described in a special or prominent manner to ensure that users can handle, display, store, and use the product safely and correctly.

Figure A.1 Spoon and Chopsticks Symbol