What are the routes to FDA compliance for food contact materials?

There are three routes to FDA compliance for food contact materials. Your solution should be capable of meeting FDA compliance through at least one of these routes. 


1: Established Food Contact Materials

    • Existing FDA regulations are specific to each material and are listed in Title 21 of the Code for Federal Regulations (CFR) parts 170 to 199. Find direct links for the following materials: General AdditivesAdhesives and Components of CoatingPaper and Paperboard; Polymers;  Adjuvants, Production Aids, and Sanitizers
    • These regulations are relevant when working with long-established materials. For example, polymer producers use these regulations when placing conventional materials on the market, and packaging manufacturers use them when looking to create compliant final packaging with already certified raw materials.
    • Each part is divided into sub-sections. For example, Part 177 is broken into sections that cover different types of polymers and regulations surrounding them. Each section then lists definitions of material types, permitted additives, specifications, test methods, and end-use restrictions for each.

    2. New Food Contact Substances

    • The Food Contact Notification (FCN) program is a formal process for the registration of new food contact materials. The FDA has a 120-day time period to review a new FCN and raise objections. 
    • If the FDA does not object, the packaging material is automatically legal.
      Materials must be produced by the approved manufacturing entity only. Otherwise, a new FCN will be required.
    3. Out of Scope of FFDCA – Exemptions from FDA approval
    • Prior Sanctioned: Substances that have been previously approved by the FDA before 1958 outlined in CFP part 181.  Be cautious of changes in toxicology, analytical testing, etc. since 1958.
    • Substances Generally Recognized as Safe (GRAS): Direct food additives that are covered in CFR parts 182, 184, and 186.
    • No Migration Exemption: If packaging is not reasonably expected to become a component of food (dietary concentration at or below 0.5 parts per billion).