Food Additive Safety

1
Food Additive Safety

• The FDC 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 safetyFood additive
use will specify foods where it may be used and
the level of usage
4
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

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• Repealed in respect to pesticides in 1996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)
• 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
• 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
• 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