GRAS List and Delaney Clause

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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.

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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.

GRAS List Classifications

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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.

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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.

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.