Request a DemoIn order to ensure the quality and safety of food contact materials (FCMs) and protect human health, National Health and Family Planning Commission of the People’s Republic of China (“NHC”now) released GB 4806.1-2016 General Safety Requirements for Food Contact Materials and Articles, GB 9585-2016 Standard for Uses of Additives in Food Contact Materials and Their Products and 51 other national food safety standards on November 18, 2016, forming China's new regulatory system for food contact materials.
What are food contact materials and articles?
According to the GB 4806.1-2016 General Safety Requirements for Food Contact Materials and Articles, 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”.
History of food contact materials and articles
Compared with developed countries and regions such as the EU, the United States and Japan, China is a late starter on the research on hygiene and safety of food contact materials and articles. Since the 1980s, China gradually established regulations and standards system for food contact materials and articles, and has been continuously improving.
(1) Preliminary Stage（1980s）
1982:
People's Republic of China Food Sanitation Law (Trial)（hereinafter referred to “Food Sanitation Law” for short）was issued, stipulating that food containers, packaging materials, food utensil and facilities and so on must comply with regulations of hygiene standards and management measures.
1989:
GB/T 12121-1989 Quality assurance system of containers was issued, stipulating that containers should not have any physical and chemical interactions with the contents and damage the contents.
1988:
GB 9685-1988 Hygienic standard for uses of additives in food containers and packaging materials
GB 9687-1988 Hygienic standard for polyethylene products used as food containers and tablewares
GB 9688-1988 Hygienic standard for polypropyrene products used as food containers and tablewares
GB 9689-1988 Hygienic standard for polystyrene products used as food containers and tablewares
……
A series of hygiene standards was issued, supporting the implementation of Food Sanitation Law and clearly stipulating the sensory and physical and chemical indexes of food packaging containers.
(2) Developmental Stage（1990s）
1991:
GB 13113-1991 Hygienic standard for polyethylene terephthalate products used as food containers and packaging materials
GB 13114-1991 Hygienic standard for polyethylene terephthalate resin used as food containers and packaging materials
GB 13115-1991 Hygienic standard of unsaturated polyester resin and glass fiber reinforced plastics used as food containers and packaging materials
GB 13121-1991 Hygienic standard of ceramics for food containers
GB/T 5009 series of test method standards match related hygienic standards
……
A series of hygienic standards for products and raw materials and supporting standards of test method were issued:
People's Republic of China product quality law was implemented in 1993
Food Sanitation Law was implemented in 1995
Food hygiene supervision procedures was released and implemented in 1997
(3) Present (Twenty-First Century)
GB18192-2000 Paper based laminated material using for aseptic package of liquid food was amended and released in 2000
GB 9685-2008 Hygienic standard for uses of additives in food containers and packaging materials was amended and released in 2008
People's Republic of China Food Safety Law（hereinafter referred to “Food Safety Law” for short）was released in 2009 which replaced the original Food Sanitation Law. Food Safety Law is the basic law for food safety management including food contact materials and articles, in which food containers, packaging materials, food utensils and facilities, detergent and sanitizer collectively referred to as food-related products.
GB 4806.1-2016 General safety requirements for food contact material and articles, GB 9585-2016 Standard for uses of additives in food contact materials and articles and other 51 national standards for food safety were released in 2016 establishing China’s new food contact materials and articles regulatory system.
GB 4806.10-xxx Paints and Coatings in Contact with Foodstuffs (Draft) was released to solict public comments in 2021 (CL news).
GB 31604.8-2021 Food Contact Materials and Articles Determination of Overall Migration was released and came into force in March of 2022, the previous version GB 31604.8-2016 was repealed at the same time.
Current main competent authorities in China
NHC and SAMR are two competent authorities in charge of food contact materials. After the institutional reshuffle in March 2018, NHC is responsible for pre-market registration of food-related products (e.g. food contact materials, new food contact additives, etc.) and formulating and updating national food safety standards for those products. CFSA (China National Center for Food Safety Risk Assessment) is responsible for the risk assessment of new food contact materials since July, 2016, including application acceptance, safety assessment, technical review and approval. CFSA mainly reviews materials of physical and chemical experiments, migration test, and toxicological information. SAMR and its local quality supervision departments are responsible for the administration of production and processing of food-related products.
Regulatory framework for food contact materials
Food Safety Law, national food safety standards, industry/enterprise standards are all regulations stipulating the compliant use of food contact materials and articles. Food Safety Law serves as a basic and fundamental regulation of FCMs. It provides general principle and some macro requirements, and all of standards must comply with the principle or the Food Safety Law. While national food safety standards/ announcements specifies more detailed requirements of FCMs, it is like an executor of Food Safety Law and stipulates FCMs’ product standard, test method, production specification etc. Industry and enterprise standards supplement requirements not mentioned in national standards and is much more detailed.
Regulatory system of food contact materials and articles
Translated standards concerning food contact materials and articles
Category | Standard Number | Name |
Basic standards | National Standard for Food Safety General safety requirements for food contact material and articles | |
National Standard for Food Safety Standard for uses of additives in food contact materials and articles | ||
Product standards | National Standard for Food Safety Nipple | |
National Standard for Food Safety Enamel articles | ||
National Standard for Food Safety Ceramic articles | ||
National Standard for Food Safety Glass | ||
National Standard for Food Safety Plastic resins used for food contact | ||
National Standard for Food Safety Plastic materials and articles used for food contact | ||
National Standard for Food Safety Paper and paperboard materials and articles used for food contact | ||
National Standard for Food Safety Metal materials and articles used for food contact | ||
National Standard for Food Safety Paints and coatings used for food contact | ||
National Standard for Food Safety Rubber materials and articles used for food contact | ||
Test standards | National Standard for Food Safety General rules for migration test of food contact materials and articles | |
National Standard for Food Safety General rules to the pretreatment for migration test of food contact materials and articles | ||
National Standard for Food Safety Determination of potassium permanganate consumption for food contact materials and articles | ||
National Standard for Food Safety Determination of loss in mass on dying of resin for food contact materials and articles | ||
National Standard for Food Safety Determination of volatile matters in resin for food contact materials and articles | ||
National Standard for Food Safety Determination of extract of resin for food contact materials and articles | ||
National Standard for Food Safety Determination of residue on ignition of resin for food contact materials and articles | ||
National Standard for Food Safety Decolorization test for food contact materials and articles | ||
National Standard for Food Safety Determination of overall migration for food contact materials and articles | ||
National Standard for Food Safety Determination of heavy metal in food simulant for food contact materials and articles | ||
National Standard for Food Safety Determination of Migration Amount of Biphenyl A for food contact materials and articles | ||
GMP | National Standard for Food Safety General hygienic practice for production of food contact materials and articles |
Update of GB 9685
In 1994, in order to regulate additive usage in FCMs, the Ministry of Health (MOH) and the Standardization Administration (SAC) jointly published the mandatory standard GB 9685 “Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials”, which was subsequently updated in 2003, 2008 and 2016. GB 9685-2016 specifies principles for use of additives in food containers and packaging materials, the types of permitted additives, scope of use, maximum level, specific migration limit or maximum permitted quantity as well as other restrictive requirements. This standard also includes some monomers and initiators during the production of food contact materials and products. It has been effective October 19, 2017.
Compared with the previous version, one of major changes of GB 9685 lies in that there is a more clear management model for raw and auxiliary materials. In GB 9685-2016, positive lists are used to manage the raw and auxiliary materials. For each category of food contact materials, including plastic, coating, rubber, silica gel, permitted additives list is provided to clearly indicate which kind of additive is permitted or not. Products with additives not included in those positive lists are illegal. In the latest GB 9685-2016, its positive list has included additives announced in NO.5 announcement and NO.11 announcement in 2012, NO.1 and NO.14 announcement in 2013 and NO.14 announcement in 2014.
Besides, here are other changes of GB 9685-2016 compared with GB 9685-2008.
Some terms and definitions have been revised
The positive list for additives used in food contact materials has changed from 958 to 1294
Special limitation of metallic element is added.
Abbreviations of plastic materials is added
Bibliography (according to CAS number or phonetic sequence) is added
In addition, NHC also approved new additives and food contact materials to satisfy the demand of FCM industry. Detailed information of those new substances is included in released announcements.
Compliance
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.”
What kinds of substance/material need a DoC?
Substances listed in the national standard positive list, including
GB 9685-2016 Table A.1-A.7
GB 4806.6-2016 Table A.1
GB 4806.10-2016 Table A.1
GB 4806.11-2016 Table A.1 and A.2
Substances approved by NHFPC in official announcement
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
Data requirements for application
Data | New food related product manufactured in China | First-time imported new food related product | ||||
General product | New additives used in food packaging, container, utensil and facilities | Expand use scope or dosage | General product | New additives used in food packaging, container, utensil and facilities | Expand use scope or dosage | |
（1）Application form | √ | √ | √ | √ | √ | √ |
（2）Physicochemical Information | √ | √ | √ | √ | √ | √ |
（3）Technical necessity, intended use and conditions of use | √ | √ | √ | √ | ||
（4）Use scope and dosage | √ | √ | √ | √ | ||
（5）Production process | √ | √ | √ | √ | ||
（6）Quality and specification requirements, testing methods and reports | √ | √ | √ | √ | ||
（7）Toxicological data for safety evaluation | √ | √ | √ | √ | √ | √ |
（8）Migration level and/or residue level, estimated dietary expose and evaluation methods | √ | √ | √ | √ | √ | √ |
（9）Relevant supporting document of its approval to use at home or abroad | √ | √ | √ | √ | ||
（10）Other information conducive to review | √ | √ | √ | √ | ||
（11）Proof files issued by the relevant departments or agencies in exporting country/region to allow the product producing or selling in the local country /region. | √ | √ | √ | |||
（12）Manufacturing enterprise investigation or certification files issued by the relevant departments or agencies in exporting country/region | √ | √ | √ | |||
（13）The entrusted applicant shall submit the power of attorney entrusted to declare | √ | √ | √ | |||
（14）The Chinese translation should be notarized by a Chinese notary authority | √ | √ | √ | |||
Supply chain and responsibilities of each link
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 National Standard for Food Safety General Hygienic Practice for Production of Food Contact Materials and Articles (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 National Standard for Food Safety General Hygienic Practice for Production of Food Contact Materials and Articles, 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 National Standard for Food Safety General Safety Requirements for Food Contact Materials and Articles.