Food additives, GRAS, and food contact compliance – USA
The Federal Food, Drug and Cosmetic Act (FFDCA) requires that human food and animal feed be safe for consumption, prepared in sanitary conditions free from harmful substances, and be properly labeled.
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
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
Our food compliance consultants can help you with GRAS self-determination, GRAS notification submission, Food Contact Notifications and more. The team is led by Leslie Patton, who has more than a decade of experience in regulatory toxicology. Leslie Patton specializes in food additives and food contact, pesticides, consumer products, and cosmetics. She has extensive experience working with industries to successfully register pesticides with the U.S. Environmental Protection Agency and Health Canada and submit new food contact notifications (FCN) with the U.S. Food and Drug Administration (FDA).
Frequently asked questions
GRAS status can be achieved through a self-determination process or via notification to FDA. Either pathway involves establishing the safety of the ingredient for its intended use.
A food contact substance may contact food during production, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding, although by definition it is not intended to have a technical effect in food. Such substances, unless they are already regulated under 21 CFR or are GRAS, typically require a FCN.