GRAS List and Delaney Clause

1
GRAS List and Delaney Clause
2
GRAS List

• Generally Recognized as Safe (GRAS) List
• 1958
• Food additives that have a long history of common
  usage in food with no known negative health
  effects.
• Over 600 additives on list -- eventually had to
  be tested
• 1969
• GRAS substances are re-examined
• Potentially hazardous items were removed from
  list
• After being re-examined, the GRAS List was
  divided into five classifications.

3
GRAS List Classifications

• Class 1
• Ingredients safe at present and anticipated
  levels of use.
• Class 2
• Ingredients safe at current usages, however, need
  more study to see if higher level usage could be
  hazardous
• Class 3
• Ingredients that have restricted use.
• Further research needed.

4
GRAS List Classifications

• Class 4
• Ingredients that the FDA needs to establish
  stricter guidelines.
• Class 5
• Ingredients recommended to be removed from the
  GRAS List.

5
The Delaney Clause

• Food, Drug, and Cosmetic Act
• set of laws giving authority to the FDA to
  oversee the safety of food, drugs, and cosmetics.
  
• Delaney Clause, which is in the Food, Drug, and
  Cosmetic Act, states
• No additive may be permitted in food if the
  additive at any level can produce cancer when fed
  to man or animals or can be shown to be
  carcinogenic by any other appropriate test.

6
Delaney Clause Controversy

• Problem
• Some harmless and common substances possibly
  induce cancer in one animal or another under
  special conditions that have little to do with
  normal food consumption
• Examples saccharin, pepper, charred meat
• Possible modification
• Modify definition of safe in regard to foods
  and use informed scientific judgments to make
  regulatory decisions.

B-4.02 -- GRAS List and Delaney Clause