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China Food Contact Materials and Articles Regulation

  •   24 Nov 2017
  •    Lily Lee

    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 (“NHFPC” for short) 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.

     

    Contents

     

    1. 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.

     

    2. 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
      • A series of hygiene standards was issued:

        • 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
        • ……
      • 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

      • A series of hygienic standards for products and raw materials and supporting standards of test method were issued:

        • 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
        • ……
      • 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.

     

    3. Regulatory system of food contact materials and articles

    Fig. 1 - regulatory system of FCM

    Fig. 1 - Regulatory system of FCM

     

    4. Translated standards concerning food contact materials and articles

    CategoryStandard NumberName
    Basic standardsGB 4806.1-2016National Standard for Food Safety  General safety requirements for food contact material and articles
    GB 9685-2016National Standard for Food Safety  Standard for uses of additives in food contact materials and articles
    Product standardsGB 4806.2-2015National Standard for Food Safety  Nipple
    GB 4806.3-2016National Standard for Food Safety  Enamel articles
    GB 4806.4-2016National Standard for Food Safety  Ceramic articles
    GB 4806.5-2016National Standard for Food Safety  Glass
    GB 4806.6-2016National Standard for Food Safety  Plastic resins used for food contact
    GB 4806.7-2016National Standard for Food Safety  Plastic materials and articles used for food contact
    GB 4806.8-2016National Standard for Food Safety  Paper and paperboard materials and articles used for food contact
    GB 4806.9-2016National Standard for Food Safety  Metal materials and articles used for food contact
    GB 4806.10-2016National Standard for Food Safety  Paints and coatings used for food contact
    GB 4806.11-2016National Standard for Food Safety  Rubber materials and articles used for food contact
    Test standardsGB 31604.1-2015National Standard for Food Safety  General rules for migration test of food contact materials and articles
    GB 5009.156-2016National Standard for Food Safety  General rules to the pretreatment for migration test of food contact materials and articles
    GB 31604.2-2016National Standard for Food Safety  Determination of potassium permanganate consumption for food contact materials and articles
    GB 31604.3-2016National Standard for Food Safety  Determination of loss in mass on dying of resin for food contact materials and articles
    GB 31604.4-2016 National Standard for Food Safety  Determination of volatile matters in resin for food contact materials and articles
    GB 31604.5-2016 National Standard for Food Safety  Determination of extract of resin for food contact materials and articles
    GB 31604.6-2016National Standard for Food Safety  Determination of residue on ignition of resin for food contact materials and articles
    GB 31604.7-2016National Standard for Food Safety  Decolorization test for food contact materials and articles
    GB 31604.8-2016National Standard for Food Safety  Determination of overall migration for food contact materials and articles
    GB 31604.9-2016National Standard for Food Safety  Determination of heavy metal in food simulant for food contact materials and articles
    GB 31604.10-2016National Standard for Food Safety  Determination of Migration Amount of Biphenyl A for food contact materials and articles
    GMPGB31603-2015National Standard for Food Safety  General hygienic practice for production of food contact materials and articles
    OthersGB1037-88Test Method for Water Vapor Transmission of Plastic Film and Sheet-Cup Method
    GB1038-2000Plastics--Film and Sheeting—Determination of Gas Transmission Differential-Pressure Method
    GB9683-88Hygienic Standard for Composite Laminated Food Packaging Bag
    GB9691-88Hygienic Standard for polyethylene resin used as food packaging  material
    GBT 5009.60-2003Method for Analysis of Hygienic Standard of Products of Polyethylene, Polystyrene and Polypropyrene for Food Packaging
    GBT 6672-2001Plastics Film and Sheeting—Determination of Thickness by Mechanical Scanning
    GBT 6673-2001Determination of Length and Width of Plastics Film and Sheeting
    GBT4456-2008Polyethylene Blown Film for Packaging Applications
    GBT21302-2007General Rules of Laminated Films & Pouches for Packaging

     

     

    5. Compliance 

    5.1 Declaration of Compliance (DoC) 

    5.1.1 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.”

    5.1.2 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 NHFPC in official announcement

     

    5.2 New food contact materials and articles application

    5.2.1  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.

    Fig. 1 - FCA0001

    • 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.

    5.2.2 Application workflow/schedule

    Fig. 1 -workflow for application

    Fig. 2 -Application workflow/schedule

    5.2.3 Data requirements for application

    DataNew food related product manufactured in ChinaFirst-time imported new food related product
    General productNew additives used in food packaging, container, utensil and facilitiesExpand use scope or dosageGeneral productNew additives used in food packaging, container, utensil and facilitiesExpand 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   

     

    6. Supply chain and responsibilities of each link

    6.1 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.

    Fig. 1 - supply chain

    Fig. 3 -Supply chain for food contact materials and articles

     

    6.2 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.