Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives

Center for Food Safety and Applied Nutrition, Food and Drug Administration, U.S. Department of Health and Human Services. (2014) Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives. Technical Report. U.S. Department of Health and Human Services.

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Abstract

The guidance alerts manufacturers to the potential impact of any significant manufacturing process change, including changes involving nanotechnology, on the safety and regulatory status of food substances. This guidance also describes considerations for determining whether a significant manufacturing process change for a food substance already in the market affects the identity, safety, or regulatory status of the food substance, potentially warranting a regulatory submission to the FDA.

Item Type: Monograph (Technical Report)
InterNano Taxonomy: Environment, Health, and Safety > Human Health
Environment, Health, and Safety > Human Health > Toxicology
Environment, Health, and Safety > Risk Assessment
Environment, Health, and Safety
Areas of Application > Food Industries
Collections: Nanomanufacturing Report Collection
Depositing User: Blake Spitz
Date Deposited: 25 Jun 2014 17:28
Last Modified: 25 Jun 2014 17:28
URI: http://eprints.internano.org/id/eprint/2213

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