Generally Recognized as Safe (GRAS) Services
Intertek’s experts can help your company successfully comply with FDA GRAS requirements.
Generally Recognized As Safe (GRAS) is an American Food and Drug Administration (FDA) designation that a chemical or substance added to food is “generally recognized as safe” under the conditions of its intended use. When the use of a substance does not qualify for the GRAS exemption, it is subject to the premarket approval mandated by the Federal Food, Drug, and Cosmetic Act (FFDCA).
With GRAS determination for specific uses of an ingredient in the United States, food ingredients are considered either as a food additive or are Generally Recognized as Safe (GRAS) for specific uses. The major difference between the two is the involvement of the U.S. Food and Drug Administration (FDA), which is required for the evaluation of the safety of food additives.
For the determination of the GRAS status of uses of a food ingredient, both technical evidence of safety ("technical element") and a basis to conclude that such evidence is generally known and accepted ("common knowledge element") is required. This evidence must be evaluated by independent scientists, qualified by their relevant experience and scientific training to assess the safety of food ingredients.
Generally Recognized as Safe (GRAS) Services
Intertek’s experts understand the intricacies of the FDA GRAS regulations and have successfully completed hundreds of evaluations, dossiers, and notification submissions for food substances generally recognized as safe.
Intertek’s US FDA GRAS services include:
- Conducting feasibility assessments and assisting with the development of a successful regulatory strategy
- Conducting literature searches and data gathering
- Identifying technical and scientific data gaps and recommending solutions
- Coordinating the conduct of toxicological studies when required
- Facilitating the publication of pivotal data to meet the "general recognition" requirement of GRAS
- Providing dietary exposure estimates and safety assessments
- GRAS dossier preparation for expert panel review
- Facilitating expert panel review
- Preparing GRAS notification submissions to US FDA
Request more information to see how Intertek can help your organization with Generally Recognized as Safe (GRAS) Services.