Safety Assessment of Food Additives Anna P. Shanklin, . Department of Health and Human Services . Food and Drug Administration Center for Food Safety and Applied Nutrition Food mittee Additives and Ingredients mittee LATEX ALLERGY August 26-28, 2003 OVERVIEW ? Introduction ? Food & Drug Law ? Evaluation of Safety ? Natural Rubber Latex (NRL) ? Latex Allergy and Food Safety ? Conclusion CFSAN ’ s Mission ? To promote and protect the public health by ensuring that: ? The food supply is safe and wholesome and cosmetics are safe ? Food and cosmetic products are honestly and accurately labeled OFAS ’ s “ Food Ingredients ” Universe ? Direct Food Ingredients ? Color Additives ? GRAS Ingredients ? Foods/Ingredients produced using modern biotechnology ? Processing Aids ? Food Irradiation Equipment ? Food Packaging/Food Contact Substances Sweeteners; Preservatives; Fat; Nutrients; Texturizers (thickeners, Emulsifiers, etc.); Flavors To process food To inspect food In food, animal feed, drugs, cosmetics,medical devices(. sutures and contact lenses) Antimicrobials(meat and poultry Processing); Defoamers; Ion exchange resins Enzymes; Fiber; Proteins; Lipids; Sugars; MSG; Antimicrobials; Phytosterols/stanols; Flavors; Infant formula ingredients Plants w/herbicide resistance or insect resistance, delayed ripening, etc.; often use GRAS concept Coatings (paper, metal, etc); New/recycled plastics including both polymers and monomers; Paper; Adhesives; Ingredients in Pkgs.(. colorants, antimicrobials, antixoxidants, etc.);Packaging material for use during food irradiation,; Food packaging “ formulations ” Food and Drug Law ? Federal, Food, Drug, and Cosmetic Act FFDCA Federal Food, Drug, And Cosmetic Act FDA Authority FFDCA “ The LAW ” OFAS & FFDCA Food Additive Provisions Sec. 409 Federal Food, Drug, And Cosmetic Act 409 Regulations LAW NOT? Food Additive “ PRE-MARKET ” APPROVAL 1958 Food Additives Amendment of FFDCA Sec. 409
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