US Food Regulations
1.1 Food Classification
In the US, food is defined as a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum. (Federal Food, Drug, and Cosmetic Act (FD&C Act), SEC. 201. [21 U.S.C. 321])
1.2 Regulatory Authorities
• FDA regulates both domestic and imported foods, except meat and poultry and processed eggs.
• USDA regulates all the fruits, vegetables, meat, poultry and processed eggs.
1.3 General Recognized As Safe(GRAS)
Under sections 201(s) and 409 of the Act, and the Code of Federal Regulations 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common
• Any substance that is Generally Recognized As Safe (GRAS) for a particular user may be used in food for that purpose without pre-market approval from FDA.
• A GRAS determination must reflect the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food.
• Those expert views must be based on “scientific procedures,” supplemented in the case of substances used in food prior to 1958 by experience based on common use in food.
• According to 21 CFR, the term “safe” means that there is reasonable certainty in the minds of competent scientists that a substance is not harmful under intended conditions of use.
There are two ways of getting GRAS status:
• Self-determined GRAS
• FDA notification
Required Documents for GRAS
• Name and all pertinent information concerning such food additive, including, where available, its chemical identity and composition;
• A statement of the conditions of proposed use of such additive, including all directions, recommendations, and suggestions proposed for the use of such additive, and including samples of its proposed labeling;
• All relevant data bearing on the physical or other technical effects such additive is intended to produce, and the quantity of the additive required to produce such effect;
• A description of practicable methods of determining the quantity of such additive in or on food, and any substance formed in or on food, because of its use;
• Full reports of investigations made with respect to the safety of such additive, including full information as to the methods and controls used in conducting such investigations
Safety assessment of food and color additives used in food and to assist petitioners in developing and submitting toxicological safety data.
of a food additive.
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