United States GRAS substances

Countries that use a positive Hst, eg, Japan, Switzerland, the former Soviet Union, and the United States, Hst ak substances akowable in flavor and foods any material not Hsted is not akowable. Any material included on a positive Hst is considered safe for its intended use. This system works wek only if there is a specific procedure to akow for the addition of new materials. In the United States there is the Food Additive Petition and the GRAS route. No new material can be used in flavor or foods unless it undergoes one of these two procedures. This assures that any new technology can be added and used after it is reviewed for safety. 

The eligibility requirements for classification of a substance as GRAS are described in 21 CFR 170.30. For a substance to be eligible for GRAS affirmation based upon its history of use in food prior to 1958, certain criteria must be met. If the substance was commonly used in food in the United States prior to 1958, then information documenting this use must be generally available (21 CFR 170.30(c)(1)). If the substance was only used in food outside the United States prior to 1958, then published documents, or other information, that shall be corroborated by information from a second, independent source that confirms the history and conditions of use, must be readily available in the country in... 

Sorbic acid is preferred to other organic acids because of its physiological harmlessness and organoleptic neutrality. In the United States, sorbic acid is a GRAS substance and its use is permitted in any food product to which preservatives may be added (Banerjee and Sarkar, 2004). Sorbic... 

Calcium carbonate is generally regarded as safe (GRAS) without any known occupational diseases associated with its handling. It is nontoxic, nonhazardous and most grades meet United States FDA codes. The United States OS HA regulates the substance under the generic total particulate limit of 15 mg/m. Specific exposure... 

In Canada and the United States, the food additive petition processes are similar and require premarket review and approval. In the United States, under the proposed GRAS Notification rule, a manufacturer can declare that a substance is GRAS if there is scientific consensus among qualified experts about its safety under the conditions of intended use. The manufacturer then notifies FDA, and if the agency has no questions, a letter of no objection is issued. 

United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) Food Additive (21 C.F.R. 170, 171, and 172) GRAS (21 C.F.R. 182, 184, and 186) Food additive. Substances Generally Recognized as Safe (GRAS) Food Additive GRAS... 

---