There’s more to packaging than meets the eye. Sure, colours and graphics are what draws consumers to packaging in the first place. But there’s lots to be said for the material itself as well, especially from a manufacturer’s point of view. To prevent chemicals transferring from packaging to food, all packaging materials must adhere to strict FDA contact material regulations.
FDA contact material regulations in a nutshellHow to make sure your packaging material meets all FDA regulations? Depending on the type of material, there are three ways to achieve FDA compliance.
1. The material has already been approvedYou can easily check if the FDA has already classified your packaging material as an Effective Food Contact Substance by consulting the FDA’s Food Contact Substance database. The FDA has also laid out all existing regulations specific to each material in the database in 21 CFR, Parts 170-199.
2. The FDA is unfamiliar with your contact materialThe FDA is aware that technology doesn’t stand still. If your contact material doesn’t show up in the database, you can (and must) have it registered by submitting a Food Contact Substance Notification. Your submission form must be accompanied by:
- A migration study that measures how much of the packaging material’s substance will migrate into food.
- An estimate of dietary exposure, calculated according to the FDA’s guidelines.
- A toxicological review.
- An environmental impact assessment.
3. The material is exempt from FDA regulationsIf you’re in luck, the material you have your mind set on is exempt from FDA regulations. However, you’ll still have to argue exemption with the FDA. There are three ways to do so:
- You can base yourself on prior sanction if the material was already approved by the FDA before 1958 (when food packaging was finally brought under the Food and Drugs Act).
- The material is generally recognized as safe: a list of those materials is published under 21 CFR, Parts 182, 184 and 186.
- The packaging material is highly unlikely to transfer to food. Proving this requires tests based on diffusion modelling.