U.S. GRAS

Generally Recognized as Safe (GRAS) determination for specific uses of an ingredient in the U.S., food ingredients are considered either as food additives or are (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 is evaluated by independent scientists (an expert panel), qualified by their relevant national and international experience and scientific training to assess the safety of food ingredients.

Intertek Cantox understands the intricacies of the GRAS regulations and has successfully completed hundreds of GRAS food ingredient evaluations, including previous failed attempts at GRAS.

Our 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; and 
• Preparing GRAS notification submissions to FDA.