Food Compliance
Intelligence & Solutions
China Food Contact Materials Regulation
Jul 28, 2021
Yilia Ye
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CONTENTS

The safety of food contact articles is a contentious issue and has received widespread attention. They are regulated in many countries because during contact with food, some hazardous substances can migrate from food packaging and containers to food products. Prolonged exposure to these chemicals poses potential risks to human health. Food contact contamination scandals have occurred frequently in China.

In 2012, Liquor products, made by a renowned Chinese Baijiu (rice liquor) manufacturer, contained excessive dibutyl phthalate (DBP), leading to widespread public panic.

In 2013, China banned the use of Bisphenol A (BPA) in the production of baby nursing bottles because the substance is understood to be an endocrine disruptor and experts say it could lead to precocious sexual development in children and may also cause cancer.

In 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 and 51 other national food safety standards on November 18, 2016, forming China's new regulatory system for food contact materials.

1. The Definition of Food Contact Materials in China


According to GB 4806.1-2016, food contact materials and articles refers to 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.

2. 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.

updated FCM authority.png

3. Regulatory Framework for Food Contact Materials


3.1 Relationship among food safety law, GB standard and industry/enterprise standard

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.  

3.2 Regulatory system of food contact materials and articles

A series of national standards are released to better regulate FCMs, including basic standards, product standards, test standards, GMP, etc. The following picture illustrates the regulatory system of food contact materials and articles.

Translated GB standards of FCM

Category

Standard Number

Name

Basic standards

GB 4806.1-2016

General safety requirements for food contact material and articles

GB 9685-2016

Standard for uses of additives in food contact materials and articles

Product standards

GB 4806.2-2015

Nipple

GB 4806.3-2016

Enamel articles

GB 4806.4-2016

Ceramic articles

GB 4806.5-2016

Glass

GB 4806.6-2016

Resins Used to Make Plastics in Contact with Foodstuffs

GB 4806.7-2016

Plastic Materials and Articles in Contact with Foodstuffs

GB 4806.8-2016

Paper and Paperboard in Contact with Foodstuffs

GB 4806.9-2016

Metal Materials and Articles for Food Contact Use

GB 4806.10-2016

Paints and Coatings in Contact with Foodstuffs

GB 4806.11-2016

Rubber Materials and Articles in Contact with Food

Test standards

GB 31604.1-2015

General rules for migration test of food contact materials and articles

GB 5009.156-2016

General Principle to the Pretreatment for Migration Test of Materials and Articles in Contact with Food

GB 31604.2-2016

Determination of potassium permanganate consumption for food contact materials and articles

GB 31604.3-2016

Determination of loss in mass on dying of resin for food contact materials and articles

GB 31604.4-2016

Determination of volatile matters in resin for food contact materials and articles

GB 31604.5-2016

Determination of extract of resin for food contact materials and articles

GB 31604.6-2016

Determination of residue on ignition of resin for food contact materials and articles

GB 31604.7-2016

Decolorization test for food contact materials and articles

GB 31604.8-2016

Determination of overall migration for food contact materials and articles

GB 31604.9-2016

Determination of heavy metal in food simulant for food contact materials and articles

GB 31604.10-2016

Determination of Migration Amount of Biphenyl A for food contact materials and articles

GMP

GB31603-2015

General Hygienic Practice for Production of Food Contact Materials and Its Products

3.3 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.

3.4 Regulations in transition

At the transition of new standards entering into force, some old and update standards may coexist. During this special period, standards both in old and new versions are effective, but the old version will be invalid after the formal implementation of the new standard.

4.Registration of New Food-related Products


4.1 Introduction to new food-related products registration

1) Who will be responsible for application?

Manufacturer or importer of new varieties;

2)    Which department is in charge of the application acceptance and technical review of new varieties of food-related products?

NHC is in charge of the application acceptance, and CFSA is responsible for technical review of food-related products.

3) 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 NHC in official announcement.

For example:A plasticizer used in plastic is not listed in table A.1 of GB 9685-2016 nor approved by NHC 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 are subject to mandatory new substance application.

4) Referenced regulations:

4.2. Registration workflow/schedule

4.3 Documents and materials required for registration

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

 

 

 

5. Declaration of Compliance (DoC)


5.1 Definition of 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(s) 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, are not only just some basic indexes, but also stipulate 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, GB 4806.1-2016 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.”

5.2 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 NHC in official announcement

6. Supply Chain and Responsibilities of Each Link


6.1 Supply chains of FCM production

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.

6.2 Responsibilities of each link

The safety of food contact materials and articles not only concerns raw and auxiliary materials and manufacturing process, but also concerns their uses. Therefore, to ensure compliance and safety of the final product of food contact materials and articles and guarantee the food safety, all operators in 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.

Here are some other valuable resources related to food contact materials, which could help you have deeper understanding about FCMs regulation in China