Understanding this legislation is key to creating effective, safe, and legally compliant packaging.
There are three routes to achieving FDA compliance.
1. 21 CFR Parts 170-199
The first route deals mainly with established food contact materials already covered by existing FDA regulations. The majority of food contact packaging are made from plastics (such as polyolefins, polyesters, polystyrene, polyamides, and many more), paper and cardboard, polymeric coatings, additives, and adhesives, all of which are classified as Food Contact Substances. These substances are covered by regulations found in parts 170-199.
To work effectively with these regulations, manufacturers are encouraged to read them very carefully, be attentive to cross-referenced listings in separate regulations, research end use restrictions, be prepared to communicate possible restrictions placed on approvals, and keep copies nearby for quick reference.
2. Food Contact Notification (FCN) Program
Typically, a manufacturer would apply for FCN approval for a new food contact substance or when seeking to use an approved substance in a new application. A clearly defined package of information is required for application, including a migration study, an estimate of dietary exposure (calculated using the FDA’s model), a toxicological review, and an environmental impact assessment. After submission, the FDA has 120 days to raise objections. If the FDA does not object within 120 days, the materials are automatically legal. After a successful FCN application, the onus for ensuring compliance moves to the packaging managers, who must focus on gathering food contact statements for FCN substances, keeping abreast of additional restrictions, and communicating down the line of production. Packaging managers must also honor the propriety nature of FCN approval; materials must be produced by the approved entity only, or else a new FCN will be required.
3. Exemption from FDA Regulation
There are several widely used packaging materials that are exempt from the FDA regulations for a number of reasons. The three most common reasons for exemption are prior sanction, substances generally recognized as safe, and no migration exemption. Prior sanction applies to any substance that received a letter of approval from the FDA prior to legislation changes in 1958. Substances generally recognized as safe (GRAS) refers to a list of substances found in 21 CFR Parts 182, 184, and 186, though options also exist for the self-determination of GRAS status. The no migration exception applies when a packaging substance is not reasonably expected to become a component of food, though the level at which no migration is considered to have taken place is contentious.
To learn more about these three routes to FDA compliance, download our webinar on the topic.
Food packaging legislation can be complicated, and there are complex differences from country to country that call for careful consideration. With careful testing and consultations, a third-party laboratory such as Smithers Pira can help both new and seasoned organizations by clarifying regulations, evaluating packaging materials, and ensuring compliance.