FDA compliance

Compliance with the requirements of the US Food and Drug Administration for packaging materials.

What is FDA compliance?

Areas of application

Requirements & Evidence

01 What is FDA compliance?

FDA compliance means that a packaging material meets the requirements of the US Food and Drug Administration (FDA). The FDA regulates materials that come into contact with food, medicines or medical products. For PE films and plastic packaging, the regulations in Title 21 of the Code of Federal Regulations (CFR) are particularly relevant.

02 Areas of application

FDA-compliant packaging materials are used wherever there is direct or indirect contact with food or pharmaceutical products. These include liners for the storage and transport of food raw materials, pharmaceutical primary packaging, and packaging for cosmetic products. FDA compliance is often a prerequisite for export to the USA.

03 Requirements & Evidence

FDA compliance requires that all raw materials used — including additives, colourants and processing aids — are listed in the approved positive lists (e.g. 21 CFR §177.1520 for olefin polymers). Compliance is demonstrated through declarations of conformity, migration tests and full documentation of the formulations used. In addition, EU Regulation 10/2011 applies to the European market and the recommendations of the BfR apply to the German market.

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