1. 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

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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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Repealed in respect to pesticides in 1996

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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