Navigating the Food Contact Material Regulations of the U.S/, EU and China from the Perspective of a Rubber Producer

Regulations from governing bodies continue to evolve and get stricter. — Image courtesy of Trelleborg

Regulators all over the world have taken different approaches to ensure food contact materials are safe for consumers. Traditionally, the European Union (EU) and the United States (U.S.) regulations have been the most comprehensive, and China is rapidly developing similar standards. Regulations from these governing bodies continue to evolve and get stricter. Therefore, it’s important for food and beverage original equipment manufacturers (OEMs) to have a components supplier that is aware of the latest legislation. This article will outline the FDA, EU and Chinese food contact material regulations.

FDA

The U.S. Food and Drug Administration (FDA) deems chemicals that could migrate from a food contact material an indirect food additive. Each individual indirect food additive for a specific application must be approved by the FDA. The most common way to do this is through the Code of Federal Regulations 21 (CFR 21). The code’s Section 177.2600 contains a list of substances approved for repeated use in rubber articles.

Another way to get approval from the FDA for a food contact substance is the Food Contact Substance Notification (FCN). This approval is specific for the company that is manufacturing or supplying the specific food contact substance. For example, if company A asks for a FCN for an antioxidant and Company B is manufacturing the same chemical substance, Company B is not allowed to rely on the FCN granted to Company A. FCN’s protect companies’ proprietary knowledge and are very specific to the FDA.

Finally, companies that can demonstrate that a substance used in their food grade materials will not migrate to the food can obtain a Threshold of Regulation (TOR) exemption. This is an exemption for food contact materials that pose no health risks, contain no carcinogens, and have a dietary concentration of less than 0.5 parts per billion. These materials receive an abbreviated review by the FDA compared to other substances.

EU

In the European Union (EU), Framework Regulation 1935/2004 and the Good Manufacturing Practice (GMP) Regulation 2023/2006 apply to all food contact materials. The Framework Regulation contains very general safety requirements for all food contact materials, with Article Three being the most important. It says materials and articles for food contact must be manufactured in compliance with GMP so their constituents do not transfer to food in quantities that could endanger human health, bring about an unacceptable change in the composition of the food or cause a deterioration in the sensory characteristics of the food, including its taste, odor and visual appearance.

There is no harmonized regulation for elastomer food contact materials in the EU, and regulations differ significantly among the member states. Test conditions and tolerances can be completely different, translations are not available creating language barriers and important substances to produce a high-performance rubber have not been considered in many member states. These inconsistencies and the lack of standardization may be a result of limited resources and experience of regulators regarding food contact rubber. Additionally, raw material suppliers may not be willing to petition for listing of new substances because the business case is not compelling.

The lack of compliance harmonization for elastomer food grade materials in the EU can be navigated by using a universal food grade material like the FoodProportfolio from Trelleborg Sealing Solutions. Trelleborg’s FoodPromaterials meet general EU safety requirements for food contact rubber because they are in full compliance with the food contact specific regulation of at least one member state and have undergone detailed migration studies. Within the EU, mutual recognition applies meaning a material that is compliant in one member state can be lawfully placed on the market in other member states as well.

Accomplishing Compliance

Dalum Beverage Equipment, a Danish startup company, needed a sealing solution for a carbon dioxide (CO₂) compressor used in the craft brewing industry. Trelleborg’s FoodPro provided the sealing solution for a compressor that captures the CO₂created during fermentation, enabling smaller breweries to meet their demands for sustainability, reliability, affordability and compliance with food safety regulations while facilitating the production of carbon neutral beer.

The CO₂ needed to be compressed without lubricants to ensure purity and make it suitable for reuse. The seals also needed to meet strict regulatory requirements for food contact materials, such as the U.S. Food and Drug Administration (FDA CFR 21), EU (Reg. EC 1935/2004) and Chinese National Standards (GB 4806.1-2016, GB 9685-2016).

Turcon FoodPro MF6, Trelleborg’s proprietary polytetrafluoroethylene (PTFE) -based material, proved the optimum compound for this application due to its performance, compliance with all major food contact regulations and ability to meet all the requirements of craft breweries.

China

China has recently conducted a major revision of its food contact legislation. The basic principle in China is similar to the FDA and EU regulations. In China, food contact rubber and additives are regulated in separate standards. Only approved substances may be used to produce food contact rubber materials and articles. China also requires GMP and migration testing with rules for migration testing described in separate standards. The biggest challenge regarding Chinese food contact material regulations is that some commonly used ingredients have not yet been approved.

Knowledge is Power

In order to comply with these varying regulations and perform the correct material tests, it’s important for food and beverage OEMs to ask their suppliers the right questions. OEMs should make sure their component suppliers can provide the following:

A Declaration of Compliance, Including:

Answers to all the topics that are requested for a certain regulation
Clarity on which application conditions are covered by the compliance statement

OEMs can also get information from relevant business associations or the National Sanitation Foundation (NSF) International. They provide valuable details when new regulations are discussed and introduced. Finally, OEMs will more easily navigate these regulations if they have a components partner like Trelleborg offering a portfolio of globally compliant food grade materials like FoodPro.

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Petra Hilt is the global manager, compliance food contact materials at Trelleborg Sealing Solutions. She is a food chemist with more than 15 years of expertise in regulatory requirements for food contact materials. She serves as a lecturer at universities and has experience in food packaging safety. She previously worked as a lab manager for food contact materials at a local food safety authority in Germany and holds a Ph.D. in natural sciences from the University of Hohenheim in Germany.