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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.
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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 safetyFood additive use will specify foods where it may be used and the level of usage
Risk Assessment • Hazzard identification • 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acceptable risk from chemical consumption as up to one additional caseper milion cases, when consumed over a lifetime • Repealed in respect to pesticides in 1996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) • 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 • 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 • 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