China Food Contact Materials

In order to ensure the quality and safety of food contact materials (FCMs) and protect human health, the National Health Commission of the People’s Republic of China (NHC) released GB 4806.1-2016 General Safety Requirements for Food Contact Materials and Articles, GB 9685-2016 Standard for Uses of Additives in Food Contact Materials and Articles, along with product standards for plastics, paper, metals, and other materials in 2016. These efforts established the standard system for food contact materials in China. Subsequently, the NHC has successively issued a series of product standards, including composite, adhesives, and inks etc., to further expand the regulatory purview of the food contact material standard system in China.

What are food contact materials and articles?

Definition of food contact materials

According to the GB 4806.1-2016 released on October 18, 2016, food contact materials and articles are defined as: 

“All kinds of materials and articles which have contacted or are expected to contact food or food additive which may transfer to food when used under the intended conditions, including food packaging materials, containers, utensils and machines that directly contact food during food production, processing, packaging, transportation, storage and selling, printing ink, adhesive, grease that may directly or indirectly contact food; Detergents, disinfectors and public water delivery facilities are not included”.

Food related products & Food contact materials

In China, according to Food Safety Law, “food related products” include food packaging materials and containers, food-applicable detergents, food-applicable disinfectants and equipment in contact with food during production. The scope of food related products is actually wider than FCMs. FCMs only include the food packaging materials and containers as well as equipment for food production.

Competent authorities

National Health Commission (NHC), State Administration for Market Regulation (SAMR) and General Administration of Customs (GAC) are three competent authorities in charge of food contact materials.

NHC is responsible for risk assessment by means of administrative approval for new food-related products (e.g. new food contact materials, new food contact additives, etc.). NHC also takes charge of risk management by means of formulating and updating national food safety standards for those products. Its subordinate office, China National Center for Food Safety Risk Assessment (CFSA), is responsible for technical review of new food contact materials, including assessment of physical and chemical experiments, migration tests and toxicological information.

SAMR and GAC play the role of supervisors. SAMR and its local supervision departments are responsible for production license, supervision and inspection of domestic food-related products. GAC is responsible for supervision and inspection of imported food-related products.

Regulatory system for food contact materials

FCM regulation system

Food Safety Law, national food safety standards, industry/enterprise standards are all regulations stipulating the compliant use of food contact materials and articles.

Usually we compare the hierarchy structure of China FCM regulations to a tree. “Food Safety Law” is like the trunk, which serves as the fundamental law of this system. It provides general principles and some macro requirements, and all of the specific standards must comply with it.

While regulations, national standards and notices are like the branches. They stipulates FCMs’ product standard, test method, production specification etc. Industry and enterprise standards, like the leaves of a tree, supplement requirements not mentioned in national standards and are much more detailed.

FCM standards

A series of national standards have been released and come into force to better regulate FCMs, including basic standards, product standards, test standards, GMP, etc. The following picture illustrates the standard framework of food contact materials and articles.

English tanslations of these FCM standards are available at ChemLinked. Please refer to the links below. 

Manufacturers' obligations

According to China FCM regulations, only substances approved by competent authorities are permitted to be used. That is the so-called “positive list” administration. The positive list of food contact substances (FCS) is derived from several national standards and NHC notices (see picture below).

The following logic diagram shows the compliant requirements for the use of food contact additives and resins.

1. For substances in the positive list, all operators in the whole supply chain should attach Declaration of Compliance (DoC) and bear necessary responsibilities of each supply chain links.

2. For substances not in the positive list yet that belong to Not Intentionally Added Substances (NIAS) or substances with an effective resistant layer, producers of the food-contact materials and articles should carry out self-assessment on safety.

3. Except for the above situation, the new food contact substances (FCS) shall get approval from NHC by submitting an application.

Declaration of Compliance (DoC)

What is DoC?

Declaration of Compliance (hereinafter referred to “DoC” for short) is a document transferred from a supplier to downstream links in the supply chain, detailing that product meet regulatory compliance requirements. The DoC provides relevant production information for compliance verification, and is a mandatory requirement in China. DoC needs to list all the applicable provisions and limitations of relevant laws and standards to help downstream links in the supply chain to have a clear idea of product regulatory status.

Chinese laws and regulations on the technical requirements for food contact materials and articles, is no longer just some basic indexes, but also stipulates limitations of ingredients and additives used for the product. Only with access to information of raw and auxiliary materials, especially to restricted substances and use conditions of food contact materials and articles, can we accurately assess the compliance and safety of food contact materials and articles. Therefore, in order to ensure the effective delivery of product information, GB4806.1-2016 General safety requirements for food contact material and articles stipulates the responsibilities of enterprises:

“8.3 The identification information should contain product name, materials, declaration of compliance of related regulations and standards, the name, address and contact information of the producer and/or the entrusting party, production date and guarantee period(application date) etc.

8.4 Declaration of compliance should contain information of regulations and standards in compliance with, restricted substance and its limitation and the compliance of overall migration level (for products only) etc.”

Supply chain responsibilities

Supply chain for food contact materials and articles

In the supply chain for food contact materials and articles, the products transferred between the upstream and downstream are mainly chemical substances, intermediate materials, final materials or molded products (hereinafter referred to as final product). The supply chain for food contact materials and articles is shown below. In which, chemical substance is the basic chemical component used in the production of food contact materials and articles, such as additives, solvents, adjuvants, colorants and other chemicals, excluding monomers or starting materials. Intermediate materials are those that need to be further processed and reshaped to produce the final product, such as basic resin, master batch, premix, bottle preform, semi-finished film/sheet and uncompressed plastic layers in composites. Final product is a product that can be used directly in contact with food but not yet in contact with food.

Responsibilities of supply chain for food contact materials and articles

The safety of food contact materials and articles is not only concerned with raw and auxiliary materials and manufacturing process, but is also concerned with their uses. Therefore, to ensure the compliance and safety of the final product of food contact materials and articles and guarantee the food safety, all operators on the whole supply chain, by focusing on the compliance and safety of the final products, shall bear necessary responsibilities, which include but not limited to the identification requirements of the conformity statement proposed in GB4806.1-2016 National Standard for Food Safety  General Safety Requirements for Food Contact Materials and Articles.

Chemical substance manufacturer: the chemical substance manufacturer shall produce products based on the applicable provisions of GB 31603 National Standard for Food Safety General Hygienic Practice for Production of Food Contact Materials and Articles, and provide the declaration of compliance for chemicals to specify the authorization of use in food contact materials and the usage restrictions. It will ensure the chemicals conform to the requirements for the production of food contact materials. If necessary, the manufacturer shall also provide the special instructions on the substance safety and proper use and help the downstream with the risk evaluation of the final products.

Intermediate material manufacturer: the intermediate material manufacturer shall be responsible for the substances/materials used/added and the substances generated during product production, to ensure materials and substances conform to the requirements of laws and regulations. The manufacturer shall request the declaration of compliance from the upstream, and then produce products based on GB 31603 (only for the materials applicable to the standard), relevant requirements of the declaration of compliance and relevant safety standards of food contact materials. As per the declaration of compliance provided by upstream and the safety analysis of its own production processes, the manufacturer shall provide the declaration of compliance for downstream customers, to describe the compliance restriction requirements of materials and additives and ensure the conformity of final products.

Final product manufacturer: the final product manufacturer shall be responsible for raw materials and intermediate materials used and substances added and generated during production, to ensure the compliance with laws and regulations. The manufacturer shall request the declaration of compliance from upstream, and then produce products based on GB 31603, relevant requirements of the declaration of compliance and relevant safety standards of food contact materials. As per the declaration of compliance provided by upstream and the safety analysis of its own production processes, the manufacturer shall provide the declaration of compliance for downstream customers as per the intended use of products and keep the supporting documents of the declaration of compliance. When direct customers are consumers or no other retailers exist (e.g. the food enterprise produces the food package for itself), it is not necessary to deliver the declaration of compliance. However, the proper and safe use and other requirements of products shall be identified according to the product information requirements of GB4806.1-2016.

New food contact materials and articles application

What kinds of substances/materials require a new substance application?

• Food packaging materials, containers and their additives not listed in the national standard positive list nor approved by NHFPC in official announcement.

For example: A plasticizer used in plastic is not listed in table A.1 of GB 9685-2016 nor approved by NHFPC in official announcement. Such plasticizer need to conduct a new substance application.

• Food packaging materials, containers and additives intended to expand the use scope or the dosage.

For example: Dosage of FCA0001 (CAS No. 25013-16-5) used in plastic is 0.2% which is more than 0.1% as required in relevant standard, or FCA0001 (CAS No. 25013-16-5) is to be used in paper and paperboard which is beyond the stipulated use scope, both of these situations need to conduct the new substance application.

• New food contact materials and additives used in tools and equipment during food manufacture or operation.

For example: Lubricant which is manufactured by new materials or add new additives and used in manufacturing facilities for production of food contact materials and articles, need to conduct the new substance application.

Application workflow/schedule

National Health Commission (NHC) is the competent authority that governs the approval of food related products. To apply for approval, the applicant needs to submit the application request online first, and then submit the paper documents on site in the NHC affairs hall. Generally speaking, feedback would be given within 5 working days. If your materials are adequate, they will be handed over to National Center for Food Safety Risk Assessment (CFSA), a subordinate office that conducts technical review of the dossiers. Otherwise NHC will inform you that you need to provide more materials.

CFSA organize experts to conduct technical review. The result of technical review will be delivered within 60 working days. There are possibilities: the first is review extension. It means the materials submitted previously are not enough. The applicant needs to supplement with other documents. Of course the review will take more time. The second is recommend for approval, after which CFSA would solicit public opinion. The third is recommend for disapproval. NHC will decide whether the substance can be approved or not based on suggested result of the technical review.

Documents and materials required for application