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A Comparison of FCM Supervision Between China and the European Union

Food contact materials (FCM) are materials and articles that come into contact with food, including food containers, packaging, machinery, and kitchenware. Regarding material types, FCM can be classified into plastics, paper and board, metal, glass, ceramics, etc. As chemicals can migrate from FCMs into foods, it is a must to supervise FCM safety.

The FCM regulatory system in the EU has already been well-developed and is commonly recognized worldwide. The regulatory system in China also developed rapidly in the past few years. To help enterprises in the EU and China know better about each other’s regulations, this article summarizes the supervision and regulation of FCM between the EU and China.

Overall comparison of the legislative framework

Taken altogether, both the EU and China have set general requirements for all FCMs and legislation for specific materials. The supervision principle and certain safety indicators in many situations are quite similar since China has drawn on the EU’s experience. For example, both China and the EU set mandatory Declaration of Compliance (DoC) requirements for plastic FCMs; both adopt positive list mechanism to manage FCM substances, etc. However, there are still some differences in certain aspects.

Table 1: Comparison of the legislative framework for FCMs in the EU and China

The EU


General requirements for all FCMs

  • framework regulation;

  • good manufacturing practice;

  • FCM additive

Regulation (EC) No 1935/2004 on Materials and Articles Intended to Come into Contact with Food

GB 4806.1 National Food Safety Standard General Safety Requirements for Food Contact Materials and Articles

Commission Regulation (EC) No 2023/2006 on Good Manufacturing Practice for Materials and Articles Intended to Come into Contact with Food

GB 31603-2015 National Food Safety Standard General Hygienic Practice for Production of Food Contact Materials and Its Products

/ (None)

GB 9685-2016 National Food Safety Standard Standard for Uses of Additives in Food Contact Materials and Articles; and follow-up notices released by the competent authority to supplement approved FCM additives

Legislation on specific materials/Product standard

  • GB 4806.2 National Food Safety Standard Pacifier

  • GB 4806.3 National Food Safety Standard Enamelware

  • GB 4806.4 National Food Safety Standard Ceramic Articles

  • GB 4806.5 National Food Safety Standard Glass Articles

  • GB 4806.6 National Food Safety Standard Resins Used to Make Plastics in Contact with Foodstuffs

  • GB 4806.7 National Food Safety Standard Plastic Materials and Articles in Contact with Foodstuffs

  • GB 4806.8 National Food Safety Standard Paper and Paperboard in Contact with Foodstuffs

  • GB 4806.9 National Food Safety Standard Metal Materials and Articles in Contact with Foodstuffs

  • GB 4806.10 National Food Safety Standard Paints and Coatings in Contact with Foodstuffs

  • GB 4806.11 National Food Safety Standard Rubber Materials and Articles in Contact with Foodstuffs

  • GB 4806.12-2022 National Food Safety Standard Bamboo and Wood in Contact with Foodstuffs

  • SN/T 2275-2009 Rules for the Inspection of Food Contact Materials - Paper and Regenerated Cellulose Materials


Requirements for specific substances

Test methods

  • GB 5009.156 National Food Safety Standard General Principle to the Pretreatment for Migration Test of Materials and Articles in Contact with Food

  • GB 31604.1 National Food Safety Standard General Rules for Migration Test of Food Contact Materials and Articles

  • GB 31604.2~GB 31604.49

Source: European Commission, Regulatory Analysis of European and American Food Contact Material Legislations, Market Access of Food Contact Plastics and Paper in China

1. Management of raw materials and additives

As mentioned above, both the EU and China use “positive list” to supervise FCM raw materials and additives. But they focus on different perspectives when supervising the safety of FCM substances. EU mainly sets risk management measures for monomers, starting substances, additives, etc., whereas China mainly focuses on the management of polymers and additives, which is similar to the strategy of the U.S.

Moreover, in China, all permitted FCM raw materials can be found in the national food safety standards for specific materials, such as permitted plastic resins specified in Annex A of GB 4806.6 National Food Safety Standard Resins Used to Make Plastics in Contact with Foodstuffs. Permitted additives can be found in GB 9685-2016 Standard for Uses of Additives in Food Contact Materials and Articles. When new substances are authorized, the competent authority (China’s National Health Commission) will release relevant notices to keep the industry updated.

However, the EU only established the Union List of substances that are permitted for use in the manufacturing of plastic materials and regenerated cellulose film. Commission Regulation (EC) No 450/2009 on Active and Intelligent Materials and Articles Intended to Come into Contact with Food indicates there will be a Union list of substances permitted for the manufacture of active and intelligent materials. However, the list has not been published yet. For other groups of food contact materials (e.g., coatings), there is no positive list at the EU level but some EU member states may have set their own national lists.

As for the authorization of new substances, both the risk evaluation agency in the EU and China are responsible for risk assessment, namely, European Food Safety Authority (EFSA) and China National Center for Food Safety Risk Assessment (CFSA). Different from China, the assessments given by EFSA are only scientific opinions to help the European Commission make decisions.

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2. Management of finished products

As disclosed in Table 1, the EU only sets specific measures for 5 materials, namely, plastic, recycled plastic, active and intelligent materials and articles, ceramic, as well as regenerated cellulose film. Measures like Commission Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food have regulated compositional requirements, specific provisions for certain materials and articles, declaration of compliance, product compliance requirements, labels, etc. However, as per the framework legislation for FCM in the EU Regulation (EC) No 1935/2004, 17 materials and articles may be covered by specific measures. For other 12 groups of materials (e.g., coatings, paper, etc.) that haven’t been covered by specific measures yet, enterprises usually refer to member states' national legislations, Council of Europe resolutions, etc.

Different from the EU, China sets forth quite a lot of product standards for different food contact materials and articles, regulating permitted substances, sanitation indicators, migration tests, labels, etc. But there is no regulation for recycled plastic in China.

3. Compliance testing

Taking the regulation for plastic materials as an example, the EU has divided foods into five types to better conduct the migration test. They are aqueous, acidic, alcoholic, fatty, and dry food. The regulation further divides foods into eight categories, such as beverages, fruit and vegetable, dairy products, etc. In China, food types for migration test can be divided into four types, acidic, non-acidic, alcoholic, and fatty food. As for specific food categories, China follows the food classification of the EU and added some extra typical Chinese foods, such as dumplings. In addition, food stimulants for different types of foods in the EU and China subject to migration tests are also different.

As for the conditions for migration testing, both the EU and China set forth the conditions for specific migration and overall migration tests; and the overall requirement are quite similar. Take the overall migration test (of plastic materials) as an example, the conditions regulated in China are only slightly different in the description of some intended food contact conditions.

Table 2: Conditions for overall migration test in the EU

Intended food contact conditions

Conditions for overall migration test

Contact time in days [d] or hours [h] at contact temperature in [°C]

Any food contact at frozen and refrigerated conditions.

10 d at 20 °C

Any long-term storage at room temperature or below, including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes.

10 d at 40 °C

Any contact conditions that include heating up to 70 °C for up to 2 hours, or up to 100 °C for up to 15 minutes, which are not followed by long-term room or refrigerated temperature storage.

2 h at 70 °C

High temperature applications for all food simulants at temperature up to 100 °C.

1 h at 100 °C

High temperature applications up to 121 °C.

2 h at 100 °C or at reflux or alternatively 1 h at 121 °C

Any food contact conditions with food simulants A, B or C, at temperature exceeding 40 °C.

4 h at 100 °C or at reflux

High temperature applications with fatty foods exceeding 121 °C.

2 h at 175 °C

Source: Commission Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food

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