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 | China | |
General requirements for all FCMs
| 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 |
|
|
Others | Requirements for specific substances
| Test methods
|
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.
Recommended materials:
How to request the authorization of a new FCM substance in the EU
Compliance of Food Contact Materials in China: Application of New Substances (Webinar)
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
Recommended webinars:
Regulatory Analysis of European and American Food Contact Material Legislations
Regulatory Compliance of Degradable Plastics for Food Contact Use in China, EU and USA
Our Services
Our FCM team of REACH24H consulting group, the founder of ChemLinked, can provide regulatory compliance services in the U.S., EU, China, Canada, MERCOSUR, Switzerland, etc. With successful experience, we have helped numerous customers solve their food contact material compliance problems in the above-mentioned countries and areas, including but not limited to Declaration of Compliance (DoC) Editing/Checking, U.S. FCN Application, China/EU New Food Contact Substance Application. Feel free to contact chengzhenyu@reach24h.com if you need any help.
