Submit FCC Monographs and Revisions

Participation in USP's public standards-setting process by industry and other stakeholders is vital to the development of authoritative and relevant FCC food ingredient monographs. USP encourages you to submit draft monographs for the food ingredients you manufacture or supply. Your draft monograph will become the starting point for the public standard. USP staff will involve you in the public process review and comment to refine and finalize the monograph for publication in the next FCC edition. To participate,

• Submit new draft monographs for food ingredients that are not yet in the FCC
• Review and comment on draft monographs published in the FCC Forum
• Propose revisions to monographs and procedures in the current FCC and submit data for proposed alternatives
• Share with USP concerns about public comments on proposed new monographs and revisions published in the FCC Forum

Participant Benefits

Submitting draft monographs and revisions to USP lets you

• Contribute to the development of quality standards and procedures for your industry
• Engage in process and procedural changes and offer expertise on food ingredients
• Minimize the flow of adulterated or substandard articles
• Demonstrate your commitment to quality in public health

The Monograph Development Process

USP strives to provide publicly available and up-to-date monograph specifications of quality for all food ingredients. As the chart indicates, the FCC standards development process begins with the submission of a food ingredient monograph draft or a request for a revision to an existing monograph. Proposals are published in the free, online FCC Forum, where interested parties can openly comment on them. The FCC Forum enables FCC staff and the Food Ingredients Expert Committee (FIEC) to gather broad input and ensure that the monographs are scientifically valid and reflect industry practice. Once approved by the FIEC and USP's Council of Experts, a new or revised monograph will be published in the next FCC edition or Supplement.

All submissions should include analytical validation data, data demonstrating that the procedure is stability indicating (if applicable), and results of analysis from three commercial batches. For complete details, please refer to the USP Guideline for Submitting New Monographs for FCC  (36KB), the USP Guideline for Submitting Revisions to FCC Monographs  (29KB), and the Checklist for Submitting Requests for Revision to the FCC  (59KB). USP's FCC team is available to answer questions and guide you through the our process of public review and comment to refine and finalize your submissions; c. Contact them team at .

Guidance Documents

Guidance Documents are intended to aid the FCC user. These tools are not official and do not affect the interpretation of the FCC or any other USP-developed compendium or publication. These documents are recommendations only to be used to determine whether a monograph does or does not comply with USP's requirements, nor do they confer any claims, rights, or guarantees that information submitted by a sponsor for a new or revised monograph will meet FCC admission criteria.

The following Guidance Documents are currently available:

• Guidelines for Provisional Standards  (17KB)
• Guidelines for Revisions  (29KB)
• Guidelines for New Submissions  (36KB)
• Summary Table of Required Documents  (59KB)

For further information please contact the FCC team ().