The Center for Food Safety and Applied Nutrition (CFSAN), a branch within Food and Drug Administration (FDA) is responsible for regulating food ingredients, additives, packaging materials, food contact substances, and foodstuff products that enter the country. The Center for Veterinary Medicine (CVM) regulates animal feed.
TSG routinely assists companies with GRAS notifications and self-determinations, Food/Feed Additive Petitions, Food Contact Notifications, end-use testing of food contact substances, and other technical and regulatory issues.
Food additives and food contact substances are subject to premarket approval by FDA unless they are Generally Recognized As Safe (GRAS) by qualified experts for a particular use. Companies may submit a Food Additive Petition or a Food Contact Notification (FCN), respectively, to meet the appropriate regulatory requirements for these product types. These submissions require substantial toxicological, chemical, and environmental data as well as dietary exposure and risk modeling.
GRAS substances are exempt from the definition of “food additive” and instead are defined as “substances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety as having been adequately shown through scientific procedures...to be safe under the conditions of their intended use.” Standards for safety of GRAS substances are as rigorous as for food additives.
Food contact substances include food packaging and packaging additives, meat and poultry sanitizers and food processing equipment. FDA regulates these materials in the U.S. by requiring compliance with existing specifications or, for new materials, notifications or other regulatory submissions.
TSG can help
- Prepare and submit Food Contact Notifications (FCN) and other submissions related to food contact materials
- Develop food additive petitions
- Prepare GRAS notices/assessments, convene expert panels
- Create dietary exposure models
- Review ingredients
- Submit establishment registration
