Generally Recognized as Safe (GRAS). Have you heard of this before? Have you ever questioned, what does that mean?
Generally Recognized as Safe is a FDA designation for a substance that is considered safe by experts under the conditions of its intended use. There are two options for obtaining GRAS: GRAS notice, and self affirmed GRAS. The GRAS notice is a submission to the FDA, in which manufacturers or sponsors provide scientific evidence supporting the safety of their food substances. This application is thoroughly reviewed by FDA experts to determine if the ingredient meets the GRAS criteria. If the review is successful, the FDA issues an official "no further questions" letter, which is also published on the official FDA website (https://www.fda.gov/food/gras-notice-inventory/recently-published-gras-notices-and-fda-letters). However, not all notifications pass the review on the first attempt; some may require additional information to address the FDA's concerns about the GRAS conclusions.
In contrast, self-affirmed GRAS allows manufacturers or sponsors to independently declare the safety of a food ingredient without undergoing FDA review. This approach provides greater autonomy but requires the manufacturer to ensure the ingredient’s safety, supported by a panel of experts. Unlike the formal GRAS notice, there is no mandatory FDA review of the evidence and conclusions. However, the FDA retains the authority to challenge self-affirmed GRAS determinations, especially if safety concerns arise. The GRAS notification process and FDA’s responses are publicly accessible on the FDA’s website.
How does this process compare to the European Union? The European Union meticulously reviews Novel Food applications through the European Food Safety Authority (EFSA). The EFSA evaluates the safety of a substance based on scientific evidence, which includes toxicological data and potential exposure levels. The European Commission, following EFSA’s opinion, grants approval, and the additive is added to the EU list of authorized food additives. The approval process is transparent, with EFSA’s scientific opinions and the Commission’s decisions made publicly available. The process is harmonized across EU member states, ensuring uniformity in food safety standards.
What are your thoughts on these differences? Are there any additives that you are aware of which are banned in EU but allowed in the U.S? Are there any additives in particular that you avoid?
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