Transcript GRAS List Classifications

GRAS List and Delaney Clause
GRAS List
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Generally Recognized as Safe (GRAS) List
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1958
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1969
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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
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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GRAS List Classifications
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Class 1
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Class 2
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Ingredients safe at present and anticipated levels
of use.
Ingredients safe at current usages, however, need
more study to see if higher level usage could be
hazardous
Class 3
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Ingredients that have restricted use.
Further research needed.
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GRAS List Classifications
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Class 4
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Ingredients that the FDA needs to establish
stricter guidelines.
Class 5
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Ingredients recommended to be removed
from the GRAS List.
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The Delaney Clause
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Food, Drug, and Cosmetic Act
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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:
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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.
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Delaney Clause Controversy
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Problem
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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
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Modify definition of “safe” in regard to foods and
use informed scientific judgments to make
regulatory decisions.