TÜV Rheinland Blog - Insights from Asia and Africa

Key differences between the Food and Drug Administration (FDA) and the European Union (EU)

Posted by TUV Rheinland on Apr 2, 2016 12:53:50 PM
TUV Rheinland

There are significant variations between different country’s systems controlling the safety of food contact materials and articles. So let’s have a closer look at the set up in the US, and in the European Union focusing on.

Authority in control

In the United States, food contact materials and articles are regulated by the Food and Drug Administration (FDA). By means of the specific CFR chapters, policy guidelines and GRAS approvals, the agency is setting benchmarks for materials safe in contact with food. On top of the federal provisions
, individual states might also release specific measures, which to date have been focusing on Bisphenol A. Comparatively, the situation in the European Union turns out to be slightly more complex. Generally, the European Commission possesses the authority to regulate food contact materials on the EU level and has been taken use of it for certain materials as plastics and ceramics or specific substances. EU member states are obliged to follow harmonized measures, but might have additional national requirements. Also, for any material not regulated on an EU level, the different member states might release provisions on a national level, which, of course, are likely to differ. In the scenario that for a certain country of destination there is no applicable EU or national measure for the material in question, one might refer to the Council of Europe’s policy statements. These are considered to reflect the minimum state of the art requirements.


Differences can be also observed in terms of the depth of enforcement. The FDA requests that both food packaging and houseware articles should bear no health hazard to consumers. Due to limited resources, the provisions are only primarily enforced for food packaging. In Europe the legal enforcement covers both food packaging and houseware articles equally.

Compliance Assessment

Both the US and the EU make use of a combination of lists of authorized substances for manufacturing and actual material/product testing. The US market focuses testing is on the individual material, while the EU focuses on the final product whenever possible. For most of the materials, EU food contact legislation would simulate the actual food contact by providing a list of food simulants and a choice of temperature/time combinations. The FDA would use different approaches for different food contact material. For example, fixed condition extraction for polyolefines is required, but with a choice of simulants and time/temperature conditions for coatings or paper in contact with food. The FDA also provides physical specification for some of the food contact materials. Under the FDA, there are also options to exempt a specific material from testing, e.g. by applying to be under the threshold of regulation or to have a specific material application assessed as “Generally Recognized As Safe”. There are no options to exempt testing in the EU.

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Story by Melanie Schubert
Regulatory and Compliance Manager, Retail
Melanie is a board approved food chemist, who received her Master's Degree from a leading German University. She has been responsible for food contact material services at the TUV Rheinland Shanghai lab for the past 5 years. In 2015, she joined our North America Retail Team as a Regulatory and Compliance Manager for food contact articles and other chemical services.

Topics: food contact