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FIGURE 7-1 Pathways for a substance to gain approval for addition to food.

FIGURE 7-1 Pathways for a substance to gain approval for addition to food.

NOTE: FDA = U.S. Food and Drug Administration; GRAS = generally recognized as safe.

stances intentionally added to food are defined as “food additives” and, in turn, that food additives must be approved by FDA before they are added to foods. The process of approval requires scientific evidence gathered by the petitioner to demonstrate that the substance—under the conditions of its intended use—meets the safety standard of a reasonable certainty of no harm.6 This standard recognizes both that safety cannot be proven with absolute scientific certainty and that a substance may be safe for one use or under certain conditions, yet possibly unsafe for other uses or under other conditions.

At the same time that Congress set in place the food additives framework, it also concluded that many substances intentionally added to foods—

6

21 CFR 170.3.



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