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Given the complexities surrounding gras determinations, the forthcoming rule is likely to prompt substantial public and industry comment The us food and drug administration (fda) is preparing to overhaul the system that governs how food and feed ingredients are recognized as safe, with a proposed rule that would make submissions of 'generally recognized as safe' (gras) notices mandatory. We are monitoring developments closely and will provide updates once the proposed rule is published.
The fda has posted an outline of a proposed rule to require the mandatory submission of generally recognized as safe (gras) notices. Food and drug administration’s (fda) spring 2025 unified regulatory agenda. In october 2025, the u.s
The proposed gras rule would amend fda’s regulations in 21 cfr parts 170 and 570 to “require the mandatory submission of gras notices” for substances purported to be gras for use in human or animal food.
The fda’s proposed rule, expected in october 2025, would require mandatory submission of gras notices for new substances, exempting only those that already have a gras regulation or a “no questions” letter, and would establish a public gras inventory. A generally recognized as safe (gras) proposed rule is one of the items on the u.s
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