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Toxicological Principles for the Safety Assessment of Food Ingredients; Public Meeting on Updates and Safety and Risk Assessment Considerations; Request for Comments
The guidance titled “Toxicological Principles for the Safety Assessment of Food Ingredients,” or “Redbook,” (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm2006826.htm) provides guidance to industry and other stakeholders (e.g., academia and other regulatory groups) regarding the information used by CFSAN to evaluate the safety of food and color additives. The Federal Food, Drug, and Cosmetic Act (the FDC Act) requires our premarket approval of the use of a new food or color additive, including the new use of an approved additive. With respect to premarket approval, the safety of food additives and color additives used in foods must be established by evaluating the probable exposure to the substance and appropriate toxicological and other safety information. Thus, approval of any new food additive or color additive used in foods depends, in part, upon the outcome of toxicity tests that are performed and evaluated before marketing. The law also allows a manufacturer to market a substance for a use without premarket approval, if the substance is generally recognized as safe (GRAS). However, general recognition of safety based upon scientific procedures requires the same quantity and quality of evidence as is required to obtain food additive approval (21 CFR 170.30(b)). The same toxicological principles apply to other types of cosmetic and food safety assessments, such as for contaminants and for dietary ingredients in dietary supplements. However, the kind of information needed varies depending on the product types based on the requirements of the FDC Act. The Redbook sets out a system of tiered recommendations for additives in foods. These recommendations provide guidance on how much toxicity testing should be done depending on the level of estimated exposure to a substance in foods. The Redbook is a guidance document that is intended to help interested parties understand FDA’s expectations regarding: Determining the human exposure that will occur from the use of the ingredient in foods; Determining which toxicity studies are appropriate; Designing, conducting, and reporting the results of toxicity studies; and Submitting the information to FDA as part of a safety assessment. Subsequent to the Redbook’s publication, we provided a related guidance document titled “Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations” (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm081825.htm) describing the information we expect in various types of submissions concerning the safety of substances added to foods, such as food contact substances (formerly known as indirect food additives), substances generally recognized as safe for a defined use in foods, and new dietary ingredients in dietary supplement products. This related guidance document illustrates how the Redbook, developed for food additive and color additive premarket reviews, can inform assessments in other regulatory contexts, including risk assessments of constituent residues.
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