Food-Contact Compliance: What EU 10/2011 and FDA 21 CFR Mean for Your Packaging

September 23, 2026Industry News

Fig.1 A QC technician in full PPE inspects film samples in the Ecopak laboratory

Food packaging is not just about looking good on a shelf. In the EU and the US, food-contact materials are regulated by law, and the compliance documents you request from a supplier can make the difference between smooth customs clearance and a stopped shipment.

EU 10/2011: The Plastic Food-Contact Framework

EU Regulation 10/2011 is the legal basis for plastic materials intended to contact food in the European Union. It lists authorised substances, sets overall and specific migration limits, and requires a declaration of compliance from the manufacturer. In practice, buyers should receive a statement confirming the film structure and inks meet the applicable limits for their food type.

FDA 21 CFR 175-178: The US Approach

In the United States, food-contact substances are regulated under Title 21 of the Code of Federal Regulations. Sections 175 to 178 cover adhesives and coatings, components of paper and board, and adjuvants used in food-contact materials. For flexible packaging, the practical question is whether the polymer, inks and additives used are compliant for the intended food and temperature conditions.

What to Ask Your Supplier

A reliable flexible packaging manufacturer should provide, on request: a declaration of compliance for the food-contact structure, material specifications, and test reports or certificates from third-party laboratories. Ask which food types the structure was tested against and whether the declaration covers inks and adhesives, not only the film.

Compliance is a supply-chain matter, not a one-time certificate. When a structure changes — a new ink, a different sealant, a lighter gauge — the declaration should be revisited.