Intertek understands the intricacies of the GRAS regulations and has successfully completed hundreds of GRAS evaluations for our clients. Our team of experts can help your company navigate the scientific and regulatory requirements for supporting the GRAS status of your ingredients.
In the United States (U.S.), 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") are required. This evidence must be evaluated by independent scientists, qualified by their relevant experience and scientific training to assess the safety of food ingredients (an expert panel).
While GRAS notifications to FDA are voluntary, a positive response from FDA provides assurances of safety to end users of the ingredient and is useful in importing ingredients manufactured outside of the U.S.
The complex and often extensive requirements for supporting the GRAS status of ingredients necessitate expert advice in developing an effective regulatory strategy. Intertek has talented regulatory and scientific specialists on staff who offer decades of experience preparing the GRAS documentation and acting as a liaison with the expert panel and FDA, ensuring a successful and timely launch of ingredients.
Generally Recognized as Safe (GRAS) Services
Intertek’s 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
- Coordinating and facilitating expert panel review
- Preparing GRAS notification submissions to FDA