US · 21 CFR Parts 175–178 and applicable FCN/TOR routes
Food-contact materials: authorised use and conditions
Identify the market and product category first. Each dossier separates legal duties, referenced standards, evidence and the comparison needed for an award.
Product Scope
Food-contact coatings, polymers, paper, adhesives and additives within their specific intended conditions of use.
Requirements
Establish each substance’s regulatory status using the applicable CFR authorisation, effective FCN, TOR exemption or other valid basis. Authorisation is limited by substance identity, supplier where relevant, food type, time and temperature. A generic “FDA report” does not establish all conditions.
Required Evidence
Full formulation, legal-status cross-reference, intended food/time/temperature, relevant migration/extraction data and supply-chain identity.
Comparison for the Awards
Where a numerical migration or extraction limit applies, compare on the same material/use basis. A substance listing alone has no numerical superiority margin.
Version & Transition
CFR inventory, FCN and TOR are distinct routes; FCN applicability must not be assumed for every manufacturer.
Official Sources
Applicability depends on the product classification, intended use, configuration and actual sales territory. Manufacturing, placing-on-the-market and testing dates, together with transition provisions, are checked as required by each applicable rule. The directory identifies sources; it does not replace assessment of the specific model. Standards are identified by reference, and their authoritative texts remain with the issuing bodies. Official source documents retain their original language.