Report raises concerns over use of GRAS food additives

April 15, 2014

The Natural Resources Defense Council claims that labeling food additives as “generally recognized as safe” (GRAS) creates a loophole in regulation.

The Natural Resources Defense Council (NRDC) has claimed that labeling food additives as "generally recognized as safe" (GRAS) creates a loophole in regulation, allowing manufacturers to add substances considered to be GRAS without specific safety determinations.

Under a rule introduced more than half a century ago, the U.S. Food and Drug Administration (FDA) allows companies to hire scientists or contractors of their choice to determine if a food additive is safe for consumption, or GRAS. But the NRDC claims that many businesses use this designation to add questionable or even dangerous chemicals they are not required to report, since the product is labeled as GRAS.

Approximately one in 10 of the 10,000 food additives used in food manufacturing today are being added based on undisclosed GRAS safety determinations, the NRDC has estimated previously. In its latest report the organization identified 275 chemicals used by 56 companies, declared GRAS based on undisclosed safety determinations. When the FDA is asked to review a GRAS determination, about 20 percent of notices are rejected or withdrawn from review.

The rule was introduced in 1958, when the approximate number of food additives used in food production and processing was about 800. Today it is over 10,000 and the outdated rule is unable to encompass all the substances in use, the report said. The NRDC has recommended that the FDA should be informed of GRAS determinations and called for the agency to publish safety concerns even when a company withdraws a review notice.

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