AAFCO definitions – Sharon Benz, CVM/FDA

Animal Feed IngredientRegulationSharon A. Benz, Ph.D.Division of Animal FeedsCenter for Veterinary Medicine, FDA

Outline• Federal Food, Drug, and Cosmetic Act• Past Regulation of Feed Ingredients• Current Status t of AAFCO FeedIngredients• Future Status of Feed IngredientRegulation2

Federal Food, Drugand Cosmetic Act (FDCA)• Defines food as ‘articles used for food or drinkfor man or other animals’• Defines a food additive as ‘any substance theintended use of which results or mayreasonably be expected to result, directly orindirectly, in becoming a component orotherwise affecting the characteristics of anyfood’• Includes those used in producing, manufacturing,packing, processing, preparing, and treating food3

Food Additive Approval• FDCA requires premarket approval of foodadditives• Foods containing unapproved “food additives” areadulterated under Section 402• Section 409 provides for a food additive petitionprocess to establish standards for additive safetyand review of the petition• Part 571 of Title 21 Code of Federal Regulationsfurther describes the food additive petitionprocess4

What is GRAS?!?5

GRAS Exemption to the Definitionof Food Additive• FDCA exempts e substances that are generally e recognized as safe (GRAS) by experts qualifiedby scientific training and experience, toevaluate its safety as having been shownthrough scientific procedures to be safe underconditions of use• OR for a substance used in food prior to 1958through either scientific procedures or experiencebasedoncommonuseinfood• GRAS status for a specific use of substance• FDCA does not require FDA make the GRASdetermination6

Basic FDCA Requirement• Any substance added to an animal feedmust be• Approved for the use as a food additive OR• GRAS for its intended use• Other types of substances addedincludenew animal drugs, color additives,pesticide chemicals, as, or prior sanctioned7

Past Regulation and AAFCOIngredient Definitions• CVM participated in the AAFCO definitionprocess for review of new ingredients foranimal feed• No safety concerns for substance• All information was supplied to supportestablishment of a new definition• Use of enforcement discretion by CVM forunapproved food additives8

Current Status of AAFCO FeedIngredients• CVM is currently serving as scientificresource to AAFCO and reviewingsubmissions when requested• CVM is no longer issuing letters directly tofirms9

Future of Feed IngredientApprovals• CVM is redesigning its food additive petitionrequirements• Tailored to safety profile of the food additive• Substances/ingredients that would have usedthe AAFCO Ingredient Definition process willneed to use• Food Additive Petition program• Similar data requirements as current AAFCOdefinitionsiti• For substances/ingredients whose use can bedetermined to be GRAS can participate p in theGRAS notification program10

Thank You11