Published in the Food Chemicals Codex (FCC), the monograph provides a mechanism for companies to use after they have achieved GRAS self-affirmation as opposed to those that have sought a letter of no objection to their food ingredients from the Food and Drug Administration (FDA). This is ostensibly known as FDA-certified GRAS.
USP said while the FDA had recognized self-affirmed GRAS since 1997,“…until now, the FCC has not had a mechanism specifically designed to establish monograph standards for food ingredients that have not undergone review by the FDA or other international regulatory authorities.”
Hence, USP’s new service functions in lieu of review by such international regulatory authorities.
USP said monograph requirements included:
- Data from at least three food-grade batches of the ingredient which clearly indicate that the commercially available product meets all proposed specifications. Certificates of Analysis were adequate.
- Complete test methods for each test used in the monograph (unless the sponsor is using tests that already appear in FCC or USP–NF). If the test methods do not already appear in FCC or some compendial source, a validation report for each method.
- Any relevant regulatory information for the ingredient. This should include the regulatory authorities that have reviewed and approved the safety of this ingredient, and documentation to demonstrate this status. For provisional monographs, the summary of the self-affirmed GRAS report will have to be submitted in lieu of a statement by regulatory authorities.
- To aid USP scientific staff and the Food Ingredient Expert Committee in evaluating proposed specifications, relevant information on the method of manufacture and chemical composition of the food ingredients should be submitted where possible.
“USP will also contact the sponsor for samples of any materials used in the proposed monograph as reference materials for potential development of a USP Reference Standard,” the company said.
“USP encourages sponsors to provide an adequate quantity of each material, determined in consultation with USP staff, to facilitate future development and distribution.”
It said provisional monographs would be put through the same rigorous public vetting process as standard monographs and a specific section of the FCCwould contain all provisional monographs.
“However, if USP is informed that the food ingredient has been approved by the regulatory authorities during the provisional monograph development process or after its publication, USP will move the provisional monograph to the ‘standard’ monograph section in FCC.”
This article has been amended to reflect the fact the USP service applies to companies that have self-affirmed GRAS, not those seeking GRAS.