Community hub
Recent from talks
Knowledge base stats:
Talk channels stats:
Members stats:
Generally recognized as safe
Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts under the conditions of its intended use. An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.
Some examples of substances recognized as GRAS include ascorbic acid (vitamin C), citric acid, and salt, which are all commonly used in food preservation and flavoring. The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958, and all additives introduced after this time had to be evaluated by new standards. FDA does not systematically reconsider the safety of GRAS substances and last did so in the 1970s–1980s.
GRAS substances can be self-affirmed upon determination by qualified non-governmental experts, with or without FDA notification, or the FDA itself can affirm:
For substances used in food prior to January 1, 1958, a grandfather clause allows experience based on common use in food to be used in asserting an ingredient is safe under the conditions of their intended use.
The FDA can also explicitly withdraw the GRAS classification, as it did for trans fat in 2015.
For new proposals, the proponent of the GRAS exemption – usually a food manufacturer or ingredient supplier wishing to highlight a food ingredient in its manufactured product – has the burden of providing rigorous scientific evidence that use of the substance in an edible consumer product is safe.
Scientific procedures for GRAS exemptions require the same quantity and quality of scientific evidence needed to obtain approval of the substance as a food additive, and are ordinarily based upon published studies but may be corroborated by unpublished studies, data, and information. FDA has not issued guidance to companies on how to document their GRAS determinations.
The substance must be shown to be "generally recognized" as safe under the conditions of its intended use. To establish GRAS, the proponent must show that there is a consensus of expert opinion that the substance is safe for its intended use. For existing GRAS items, new uses should not substantially exceed historical occurrence levels of the substance in the diet.
Hub AI
Generally recognized as safe AI simulator
(@Generally recognized as safe_simulator)
Generally recognized as safe
Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts under the conditions of its intended use. An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.
Some examples of substances recognized as GRAS include ascorbic acid (vitamin C), citric acid, and salt, which are all commonly used in food preservation and flavoring. The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958, and all additives introduced after this time had to be evaluated by new standards. FDA does not systematically reconsider the safety of GRAS substances and last did so in the 1970s–1980s.
GRAS substances can be self-affirmed upon determination by qualified non-governmental experts, with or without FDA notification, or the FDA itself can affirm:
For substances used in food prior to January 1, 1958, a grandfather clause allows experience based on common use in food to be used in asserting an ingredient is safe under the conditions of their intended use.
The FDA can also explicitly withdraw the GRAS classification, as it did for trans fat in 2015.
For new proposals, the proponent of the GRAS exemption – usually a food manufacturer or ingredient supplier wishing to highlight a food ingredient in its manufactured product – has the burden of providing rigorous scientific evidence that use of the substance in an edible consumer product is safe.
Scientific procedures for GRAS exemptions require the same quantity and quality of scientific evidence needed to obtain approval of the substance as a food additive, and are ordinarily based upon published studies but may be corroborated by unpublished studies, data, and information. FDA has not issued guidance to companies on how to document their GRAS determinations.
The substance must be shown to be "generally recognized" as safe under the conditions of its intended use. To establish GRAS, the proponent must show that there is a consensus of expert opinion that the substance is safe for its intended use. For existing GRAS items, new uses should not substantially exceed historical occurrence levels of the substance in the diet.