Food Additive Safety The FD&C Act stipulates that food additives be functional and that they must possess a low or insignificant risk to humman health Assessments of food additive are based on assessment of risk Risks and benefits must be clearly displayed for all consumers

Major Concerns Allergens Illness Birth and developmental defects Reproductive abnormalities Cancer development

Additive is approved only on the basis of scientific evidence of its safety Food additive use will specify foods where it may be used and the level of usage

Risk Assessment Hazzard identification Dose response assessment Linkage to specific health effects Illness Birth or developmental defects Repoductive abnormalities Cancer Dose response assessment Short term Life time No threshold for cancer

Testing for Safety (See lecture notes for procedures of those underlined) Acute Toxicity Short-term Toxicity Sub-chronic Toxicity Metabolic and Pharmacokinetic Studies Mutagenicity Tests In vitro Carcinogenicity Tests In vivo Carcinogenicity Tests Reproductive Tests Chronic Feeding Studies

Risk Assessment (cont.) Dose Response (cont) LOEL – lowest observed level effect NOAEL –no observed level effect ADI – acceptable daily level (NOAEL/100 if based on animal studies & NOAEL/10 of based on human studies Exposure Assessment Difficult to assess because of differences in consumer food habits Risk characterization Qualitative Quantitative

Risks Associated with Food Supply (ranked in order of importance Foodborne hazards of microbial origin Nutrtional hazzards Environmental contaminant hazzards Foodborne hazards of natural origin Food and color additives Often perceived by consumers as #1. One reason for this perception is that they must be proven safe and absolute safety can not be proven

Delaney Admendment Prohibits use of additives that cause cancer in any animal at any concentration FDA has defined acceptable risk from chemical consumption as up to one additional caseper milion cases, when consumed over a lifetime Repealed in respect to pesticides in 1996

Allergens New law has passed congress and waiting for signature. Will require clear identification of any of the 8 major food alergens - Milk Eggs Fish Crustacean shellfish Peanut Tree nut Wheat Soybeans

Allergens (Cont. The 8 major allergens must be labeled using their “common or usual name” Allergens must be identified if they are present in “hidden” ingredients, such as spices, flavorings, additives and colorings

Hypersensitive Reactions Hypersensitivity A small amount produces systems, can be fatal Allergy Immunologic mechanisms involved in the pathogenisis Atopic alleergy Mediated by immunoglobulin E Intollerance Asmall amount of material causes reactions similar to that of an allergen, but immunologic mechanisms not involved

Allergic Reactions Anaphylactic (atopic) Cytotoxic Symptoms appear within minustes and disappear within hours. Urticaria,, allergic rhinitis, conjunctivitis, darrhea, sever itch) Cytotoxic Rarely caused by food additives; destruction of platelets, causing purpura Immunocomplex disease Immunoglobuline G and M form complexes with the allergen, resulting in purpura, articaria, arthritis and other symptons Delayed allergy -A rash similar to that caused by virus exanthema; granulomatosis

Intollerance Non-specific histamine liberation Intestinal diseases Fruits, citrus, strawberry, cocoa, etc Intestinal diseases Gluten intollerance causing skin and intestinal disorders Enzyme deficiency Diharrhea and colic in lactose deficiency Psychrological causes may underlie various kinds of skin and other reactions

Reactions to Food Additives Histamine and tyramine Migraines, intensitinal symptom Sodium nitrite Urticaria, headaches, intestinal disorders Phenylethylamine Headaches Sulfur dioxide &sulfites Athmastic symtpoms; may relate to sulfite oxidase deficiency

Reactions to Food Additives (cont.) Azo dyes – BTH, BHA, parabens Monosodium glutamate Wine Delayed sensitivity, manifested as eczema Histamine releasing action of acetaldhye Richness of histamine in cerain red and white wines Benzoate intollerance Quinine intollerance Sulfur dioxide intollerance

Benefits Health benefits Supply benefits Prevent or reduce specific disease Enhance nutrition Supply benefits Prevent spoilage Provide new sources for desired functions Hedonic (sensory satisfaction) Improve color, flavor and/or texture Convenience Time saving during preparation