Team:LMU-Munich/Policy/Acceptance/GRAS

From 2014.igem.org

GRAS Status

GRAS is an acronym for "Generally Recognized As Safe". The term emerged 1958 from the Federal Food, Drug, and Cosmetic Act. The purpose of this Act was to ensure premarket review of food additives leading to approval by the FDA, the Food and Drug Administration. However, to avoid the FDA being paralized with recognition of basic food ingredients like flour and sugar, an exemption was made for substances that are commonly known to be innoxious. Consequently, the GRAS status was introduced.

The GRAS status inherits two components. First, technical evidence of safety, and second the condition that such evidence is both generally known and accepted. This must be confirmed by independent experts.

In 1997, the FDA also replaced the affirmation process through petitions with regulations that allow for mere notifications.

The GRAS list of the FDA doesn't claim to be complete. Substances can be GRAS without being recorded in the list already. But despite the GRAS classification, on should keep in mind that it doesn't guarantee ingredients are safe to be added to food indiscriminately. GRAS status can in fact contain restrictions and limitations.

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