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GRAS is an acronym for the phrase Generally Recognized As Safe. The phrase was used in the 1958 Food Additives Amendment to the Federal Food Drug and Cosmetic Act ("FD&C Act") to exempt certain food ingredients from the definition of food additive. Because the amendment gave new power to FDA to clear food additives only if they were safe before they could be sold, Congress did not want FDA to be flooded with petitions asking them to affirm the safety of flour, salt, gelatin, sugar and hundreds of other familiar and commonly used food ingredients.
FDA promptly compiled a list of GRAS substances but acknowledged in the introduction to the list that the list was incomplete. The FDA also published the procedural regulations for GRAS status in 21 CFR 170.35(d) as shown below:
(d) The food ingredients listed as GRAS in Part 182 of this Chapter or affirmed as
GRAS in Part 184 or Sec. 186.1 of this Chapter do not include all substances that
are generally recognized as safe for their intended use in food. Because of the
large number of substances the intended use of which results or may reasonably
be expected to result, directly or indirectly, in their becoming a component or
otherwise affecting the characteristics of food, it is impracticable to list all such
substances that are GRAS.
In 1970 FDA began a lengthy review of GRAS ingredients that lasted for more than a decade. In 1972 they established guidelines for the submission of GRAS affirmation petitions for new ingredients. Food ingredients affirmed as GRAS are listed in Part 184 of Title 21 of the Code of Federal Regulations. Substances not affirmed in the review are still listed in the remnant of the original GRAS list in Part 182. A partial list of substances considered GRAS for food packaging materials appears in Part 186.
In 1997, in a cost cutting move, FDA abandoned the GRAS affirmation petition process and proposed procedural regulations that allow for the submission of GRAS Notifications. Although the regulations for GRAS notifications are not final, FDA accepts notifications and posts the review on their website. It should be noted that submission of these notifications is not required but is voluntary.
FDA & Questions & Answers
FDA published a Q & A document on the subject of GRAS in 2002.
The Q & A document acknowledges several important concepts:
- A substance can be GRAS even if not listed by FDA.
- GRAS status does not mean that the ingredient is safe to add to food indiscriminately.
- GRAS status can apply to a defined low level of an ingredient added to foods or to a limited set of foods.
- GRAS can apply to substances for direct addition to food, used in food processing or in food packaging or other food contact materials.
- GRAS status can also apply to ingredients used in animal feed.
- There is no GRAS exemption for color additives.