FDA GRAS main program overview

FDA's Generally Recognized as Safe (GRAS) program for animal food under 21 CFR 570 and 21 CFR 582 establishes categories of substances permitted in pet food. GRAS status applies when substance is generally recognized among qualified experts as safe under intended use conditions. Self-determination: GRAS self-affirmed under 21 CFR 570.30. Self-affirmation requires publicly available scientific basis (peer-reviewed studies, extensive history of use) and unanimous expert opinion. Voluntary notification: FDA GRN program (started 1997) where manufacturer voluntarily submits GRAS conclusion to FDA for review. FDA may issue 'no questions letter' confirming GRAS status. Key GRAS categories for pet food: (1) GRAS food substances in 21 CFR 582 (Section 582.1 nutrients; 582.100 preservatives; 582.3640 anticaking agents; 582.5279 rosemary extract; 582.5062 propylene glycol etc.); (2) GRAS food contact substances in 21 CFR 174; (3) Thresholds of Regulation 21 CFR 170.39 - substances migrating from food contact articles at <0.5 ppb do not require listing. For pet food specifically: insect protein (BSF, cricket, mealworm), algae, krill, bovine plasma are popular novel GRAS submissions. The 2024 GRAS Notifications Register includes 1000+ entries; 60% are for human food with secondary pet food applications. Source: pdf-raw/fda_gras_main_20260714.html parsed.