China Food Contact Materials Regulation

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, with prolonged exposure causing chronic risk to human health. Food contact contamination scandals have occurred frequently in China. In 2012, Liquor products, made by a reknowned Chinese Baijiu (rice liquor) manufacturer, contain excessive dibutyl phthalate (DBP). The media attention surrounding the occurrence caused widespread public panic. While this occurrence was unintentional as DBP confers no commercial benefit and actually thicken liquids whereas spirits need to be transparent and clear without precipitation, impurities or suspensions it highlighted a major shortcoming in regulatory supervision. Plasticizers may leak from PVC tubes or vessels used for storage or transportation as well as plastic caps. From this case, food manufacturers should not only pay attention to the containers of final products but the production equipment, transportation tubes, etc. Last year 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 the early sexual development of children and may also cause cancer. In brief, to ensure the safety of these food contact materials is of great importance to human health. 

Contents

Part 1.The Definition of Food Contact Materials in China

Food contact materials (known as food containers and packaging materials in China) means those products made of paper, bamboo, wood, metals, porcelain, ceramics, plastics, rubber, natural fibers, synthetic fibers, glass and composite packaging materials that are intended to come into contact with foods or coatings in direct contact with food or additives. Food tools and devices, including machines, pipes, conveyer belts, containers, appliances, tableware and other objects that have direct contact with food or additives during production, distribution and use of food or additives, are all within the scope of FCMs.

Part 2.Current Main Competent Authorities in China

After the institutional reshuffle in March 2013, NHFPC (former MOH) 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. The AQSIQ and its local quality supervision departments are responsible for administration of production and processing of food-related products.   

Part 3.Regulatory Framework for Food Contact Materials

The current regulatory framework for FCMs mainly consist of Food Safety Law 2009, hygienic standards for specific materials and their finished products and corresponding testing standards as well as GB 9685 for food contact additives, supplemented by a number of industrial standards, local standards and company standards. According to Article 36 and 62 of the Law, the purchase, use and importation of food-related products not complying with food safety standard are prohibited.

A series of hygienic standards for FCMs have been issued in China since 1980’s, such as GB 9691-1988 for polyethylene and GB 11680-1989 for paper. These hygienic standards describe organoleptic characteristics and set physical and chemical requirements, such as heavy metal migration limit, consumption of potassium permanganate, evaporation reside, etc. However, since most of them were released in 1980’s and 1990’s, they have been outdated and inadequate to meet current requirements. It is worth noting that there are two types of standards for some plastic, one for raw material and the other for finished product, which is much different to the similar regulations in EU and US. For example, GB 9691-1988 is the hygienic standard for polyethylene resin used in the manufacture of FCMs, while GB9687-1988 is the hygienic standard for polyethylene finished products used as FCMs.

There is also a raft of testing standards in line with hygienic standards. For instance, GB/T 5009.58-2003 is the corresponding testing standard for GB 9691-1988. But not every material, especially the newly developed one, has its own testing standard.

A specialist from a testing lab stated, the safety risks induced by different materials vary, for example, plastic and rubber products have the pose a potential risk of migration of their individual monomer components while processing acids; metallic materials, porcelains and ceramics may release heavy metal irons. Glass may release heavy metal irons and silica while the migration of some functional processing aids and sterilizing agents used during paper production is also a risk. Food may also easily get contaminated by ink painted on the packaging and containers. Most testing cases are related to plastic (including resin and moldings) and rubber products, followed by metals, glass, ceramics, porcelains and coatings. A few cases are about paper, composite packaging and plant fiber derivatives.

Click here to download the list of existing standards regarding food packaging materials

GB 9685

In 1994, in order to regulate the additive usage in FCMs, the Ministry of Health (MOH) and the Standardization Administration (SAC) jointly published the mandatory standard GB9685 “Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials”, which was subsequently updated in 2003 and 2008. GB 9685-2008 specifies principles for uses of additives in FCMs, a positive list of 958 permitted additives, scope of use, maximum level, specific migration limit or maximum permitted quantity as well as other restrictive requirements.

However, industry has voiced serious concerns that there are many other food contact additives already in use in the Chinese market which have been approved for use in the EU & USA or have a history of safe use which have not yet been included in the standard. To improve this situation, in 2009, the clean-up work of food packaging materials was initiated to collect and assess FCMs additives that have a history of safe use among the various food enterprises but not included in the GB 9685-2008. As a result of this process, NHFPC (Former MOH) released two positive lists of food contact additives, including

At present, only additives covered by the GB 9685-2008, the above three positive lists and newly-approved by MOH (now NHFPC) can be used as food contact additives in China. Otherwise, they will be regarded as new food contact additives which need pre-market approval by NHFPC prior to use, according to the following two rules:

  • Administrative Provisions on Licensing of New Varieties of Food-related Products
  • Provisions on Application and Acceptance of New Varieties of Food-related Products

Until now, three new food contact additives have been approved:

  • 1,3:2,4-di-O-(p-chlorobenzylidene)-D-sorbitol (CAS No. 82203-23-4)iv
  • 2-Propen-1-aminium, N,N-dimethyl-N-2-propenyl, chloride, polymer with ethanedial and 2-propenamide (CAS No. 32555-39-8)
  • 2-Propen-1-aminium, N,N-dimethyl-N-2-propenyl, chloride, polymer with 2-propenamide (CAS No. 26590-05-6)

It is noted that NHFPC is revising GB 9685-2008 and a consolidated positive list is expected to be included in the amended version.

Regarding the plasticizer incident mentioned above, plasticizers, namely phthalate, can be dangerous to male fertility and stimulate female precocious puberty, which can cause liver cancer through chronic exposure. GB 9685-2008 sets specific requirements for some phthalates used in FCMs:

Name

CAS No.

Scope of Application

Maximum level (%)

Specific Migration Limit (mg/kg)

DEHP

117-81-7

plastics

PE,PP,PS,AS,ABS,PA,PET,PC,PVC: Appropriate use according to production needs

1.5 (SML)

Coatings

Appropriate use according to production needs

Rubbers

Appropriate use according to production needs

Adhesives

Appropriate use according to production needs

DMP

131-11-3

Plastics

PP,PE,PS:3.0

 

Adhesives

Appropriate use according to production needs

DBP

84-74-2

Plastics

PE,PP,PS,AS,ABS,PA,PET,PC,PVC,PVDC:10

.0.3 (SML)

Rubbers

10.0

Adhesives

Appropriate use according to production needs

DIBP

84-69-5

Plastics

PVC:10.0

 

Coatings

Appropriate use according to production needs

Rubbers

Appropriate use according to production needs

Adhesives

Appropriate use according to production needs

DINP

28553-12-0

Plastics

PE,PP,AS,PS,ABS,PC,PA,PVDC,PET,PVC,UP: Appropriate use according to production needs

9.0 (SML)

DIOP

27554-26-3

Plastics

PE,PP,PS,AS,ABS,PA,PET,PC,PVC,PVDC: 40.0

 

Apart from limitation requirements for above phthalates, it is clearly stipulated in GB 9685-2008 that they can only be used in materials contacting with non-fatty foods and should not be used in materials in contact with baby foods. The test method in China is GB/T 21928-2008 Determination of Phthalate Ester in Food Plastic Packaging Materials, to which manufactures can refer to test 16 phthalates, including DMP, DEP, DIBP, DBP, DMEP, BMPP, DEEP, DPP, DHXP, BBP, DBEP, DCHP, DEHP, DIPP, DNOP and DNP.  

Part 4.Registration of New Food-related Products

Both food contact materials and food contact additives are regulated as “food-related products” in China. New varieties of food-related products must be approved by NHFPC first. According to the Provisions on Administrative Licensing of New Varieties of Food-related Products, new varieties of food-related products refer to those new materials, new raw materials or new additives of food packaging materials, containers, detergents, disinfectants and tools and equipment for food production and operation.

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?

The National Center for Health Inspection and Supervision (NCHIS) under the NHFPC

3.    General registration procedures

Step 1: preparation and submission of required documents

Companies who want to apply for registration of new varieties of food-related products need to submit the following documents to the NCHIS for technical review

  •  Application form;
  • Physical and chemical properties;
  • Technical necessity, purpose and conditions of use;
  • Description of production process ;
  • Quality and specification requirements, testing methods and reports;
  • Toxicological safety evaluation data;
  • Migration level and/or residue level, estimated dietary expose and evaluation methods
  • Relevant supporting documents of the state of its approval at home or abroad;
  • Other information conducive to review

Imported new varieties of food-related products require the following additional information:

  • Free sale certificate issued by the authority in the country of origin;
  • Supporting document of the examination or accreditation of the manufacturer issued by the relevant agency or organization of the country (region) of the manufacturer;
  • The applicant entrusted needs to submit the power of attorney;
  • Chinese translation notarized by a notary organization in China

The physical and chemical information includes:

  • Basic information: chemical name, common name, chemical structure, molecular formula, molecular weight, CAS number, etc.
  • Physical and chemical properties: melting point, boiling point, decomposition temperature, solubility, products resulted from decomposition or transformation during manufacture or use, possible interaction with food ingredients, etc.
  • If the substance is an inseparable mixture, the above-mentioned data on its main components should be provided

Technical necessity, usage and conditions of use information include:

  • Technical necessity and usage information: intended use, scope of use, maximum dosage, minimum dosage that achieves the desired function and the technical effect of use.
  • Conditions of use information: food types that it may contact during application (water-rich food, oil or fat rich food, acid food, alcohol-containing food), time and temperature that it is in contact with food, whether it can be used repeatedly, ratio of area/volume of food containers and packaging materials contacting food.

The description of production process shall include raw and auxiliary materials information, flow chart of manufacturing process and written descriptions, technique parameters of each step, etc.

The quality and specification requirements include purity, compositions and contents of impurities as well as corresponding testing methods and reports.

Higher migration levels require stricter toxicological data. According to the testing result of migration level, there are four types of data:

Migration level

Toxicological data

1.      <=0.01mg/kg

analytical data of the structure and activity and other safety research literatures

2.      >0.01mg,<=0.05mg/kg

Ames test, , micronucleus test of bone marrow cell, in vitro mammalian cells chromosome aberration test or in vitro mammalian cell gene mutation test

3.      >0.05mg,<=5.0mg/kg

data in level 2 + 90 days sub-chronic oral toxicity test in rats

4.      >5.0mg-60mg/kg

data in level 3 + acute oral toxicity + reproduction and development toxicity (two-generation and teratogenicity test) + chronic oral toxicity and carcinogenic test

If the new variety average molecular weight is greater than 100 Dalton, toxicological data of monomers should be provided.

Information on migration level and/or residue level, estimated dietary exposure and evaluation methods should include:

  • According to the intended use and conditions of use, testing data of migration of the new variety into food or food simulants and testing methods of migration or testing reports of migration should be provided.
  • Residue levels of components transformed or untransformed in food containers and packaging materials and testing methods of residues or testing reports should be provided.
  • Estimated dietary exposure and evaluation methods
  • Testing reports should be issued by foreign testing labs that have relevant testing ability or domestic testing institutions with qualification.

Step 2: technical review

The Review Agency shall organize medical, food, chemical and materials experts to conduct technical review on the safety of the food-related new product variety and form the technical review conclusion within 60 days after accepting the application. If the technical review requires any supplementary information, the Review Agency shall inform the applicant in written form in a timely fashion. The applicant must submit the required supplementary information in time.

Step 3: approval

After public consultation, the NHFPC will make an announcement to approving the new variety of food-related product based on the conclusion drawn from technical review.