FAQs: Food Chemicals Codex (FCC)

1. What is the FCC?

The Food Chemicals Codex (FCC) is a compendium of internationally recognized standards for the identity, purity, and quality of food ingredients. It features over 1,200 monographs, including food-grade chemicals, processing aids, food ingredients (such as vegetable oils, fructose, whey, and amino acids), flavoring agents, vitamins, and functional food ingredients (such as lycopene, olestra, and short chain fructooligosaccharides).

2. Why is the FCC important?

Food production, from "farm to fork" is a long, complicated, and ever more globalized process. Potential vulnerabilities that may affect the integrity of food ingredients are increasingly scrutinized by regulators, retailers, and consumers. The FCC serves two key roles in this area: 1.) helping to limit the introduction of potential problems at the ingredients level, and 2.) serving as a widely acknowledged quality benchmark in the global marketplace for food ingredients. FCC standards are recognized around the world by regulatory agencies, food processors, and ingredient suppliers as the basis for defining "food grade" ingredients.

3. How can I subscribe to the FCC?

Visit the FCC Products section for more information or call USP Customer Service at 1–800–227–8772 (U.S. and Canada), +1–301–881–0666, or 00–800–4875–5555 (select Europe). You can also contact your local USP Authorized Distributor.

4. What is USP's role in the FCC?

The FCC was originally published by the Institute of Medicine from 1966 until 2006. In August 2006, publication of the FCC was assumed by USP, a not-for-profit, science-based, non-governmental standards-setting organization. USP's mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. With a nearly 200-year history of producing public standards for drugs, excipients, and dietary supplements, USP is ideally suited to administer an orderly, timely, and transparent scientific process for developing food ingredient standards. USP's well-established revision structure promotes appropriate stakeholder participation and input, while ensuring the integrity and objectivity of the standards-setting processes..

5. What data do I need to get a new ingredient listed in the FCC or to modify an existing monograph?
6. What is the FCC Forum?

The FCC Forum is an online publication that is used to inform stakeholders of proposed changes to the compendium in an open and transparent manner. The forum, which is free and open to everyone, also includes information about submitting comments, as USP welcomes input from any FCC Forum user. Comments and feedback from FCC subscribers and other interested parties in industry, academia, and elsewhere are critical to the transparent and scientifically rigorous process that culminates in the final approval of FCC standards by a group of independent and established scientific experts: the Food Ingredients Expert Committee. The FCC Forum is launched twice per year: going live June 30 and December 31. Each FCC Forum has a 90–day comment period.

7. Is a subscription required to access the FCC Forum?

No. The FCC Forum is free of charge, and any interested party can access the FCC Forum online and comment on a proposal. Forum participants simply need to complete a free, one–time registration to establish a username and password.

8. How does the FCC relate to JECFA?

The FCC and standards from the Joint FAO/WHO Expert Committee on Food Additives (JEFCA) are both used throughout the world. The FCC is a more comprehensive compendium and includes ingredients that are not considered by JECFA. More specifically, the FCC is a compendium for all food ingredients, while JECFA considers only "food additives" for inclusion in its compendium. Examples of substances included in the FCC, but not in JECFA standards, are soybean oil, sucrose, fructose, and sodium chloride -- substances considered by JECFA to be foods or food ingredients, but not "food additives." Furthermore, the FCC considers for inclusion essential oils, functional food ingredients, and U.S. GRAS-Notified and GRAS-self-determined ingredients. The broader range of ingredients encompassed by the FCC generates a compendium for the food industry that is often considered more complete and more useful.

9. What is the difference between an FCC monograph and a GRAS dossier?

An FCC monograph provides specifications and analytical methodologies that can be used to characterize and confirm the identity, purity, and quality of food ingredients. A GRAS (Generally Recognized as Safe) dossier is an assessment of the safety of a food ingredient for its intended use. GRAS dossiers may be prepared by ingredient suppliers, food processors, or external consultants with relevant scientific expertise.  In the United States, there is no legal requirement that FDA review or evaluate a GRAS dossier, and it is up to the manufacturer to determine whether to share such a dossier with the Agency. GRAS dossiers that are formally shared with FDA are called “GRAS Notices.”  Where GRAS dossiers are not made publicly available or shared with FDA, they differ from FCC monograph development, as the latter process involves publication in the FCC Forum and solicitation of feedback from all interested stakeholders to develop the final monograph.  The FCC and GRAS dossiers can be inter-related in that parties preparing GRAS dossiers may reference FCC monographs and methods as industry standards for defining and determining the identity, purity, and quality of the food ingredient that is the subject of a particular dossier.

10. What benefits can I obtain from the use of USP Reference Standards in FCC methods?

The combination of USP Reference Standards and FCC monographs assists the food industry and the analytical community in the following ways:

  • Increased safety of food ingredients: Stringent identity criteria in an FCC monograph, coupled with analytical testing of a USP Reference Standard (a real-life sample of the food ingredient), allow food manufacturers to identify any potential adulteration of a food ingredient and thus safeguard their products and, ultimately, the consumer.
  • Protection of the identity of food ingredients: Food ingredient producers that sponsor the development of a monograph and associated Reference Standard will enjoy additional protection of the identity of their product by helping to ensure that an authentic sample will be publicly available. This authentic sample will allow any customers (prospective or current) in the supply chain to evaluate their own materials for purity and authenticity, and thus increase the marketplace integrity of the food ingredient.
  • Enhanced reliability of analytical test results: Reference Standards are frequently used by test laboratories to calibrate analytical methods or as quality control samples. Both uses help increase the reliability of analytical test procedures, aid in quality audits, and generally enhance the level of confidence in test results. 
11. Where can I buy FCC Reference Standards?

USP offers a wide variety of Reference Standards. Visit our Reference Standard Catalog page to browse and buy Reference Standards, ask a technical question, find an account manager, and more.

12. What are the effective dates for the FCC and its Supplements?

The FCC and its Supplements are effective 90 days after publication. A table detailing the specific effective dates can be found in each of the printed products.

13. Where can I learn more about the Food Ingredients Expert Committee?

USP Expert Committees are responsible for developing and revising standards for medicines and foods that appear in USP compendia and in other related publications. For more details please visit: Members of the Council of Experts.

14. Is the FCC available online?

Yes. With the First Supplement to the Tenth Edition, FCC introduced a new online format with these convenient features:

  • Same quality content as in the print version
  • Keyword and advanced search functionality
  • Printing, bookmarking, copying, and pasting, among other user-friendly features
  • Password accessibility from any computer, 24 hours a day
15. How can I learn more about the FCC?

Subscribe to our free quarterly FCC e–Newsletter, and visit the FCC Web site.

16. What are FCC Analytical Materials (FAMs)?

FCC Analytical Materials are fit-for-purpose materials designed specifically for the food industry and can be used for method development, method verification, method transfer, method lifecycle management, method validation, or for other purposes.

17. How are FCC Analytical Materials (FAMs) different from USP Reference Standards?

USP reference standards for food ingredients are highly characterized materials to help you verify the identity, quality, and purity of the food ingredients you buy or sell. They are extensively characterized and specified for use in the FCC and include sweeteners, colorants, flavoring agents, fats and oils, infant formula ingredients, processing aids, preservatives, nutrients, and more.

FCC Analytical Materials are fit-for-purpose materials designed specifically for the food industry and may be used with FCC monographs. They can be used to help you develop your own method and help verify the identity and quality of the ingredient. FAMs have no compendial applications in the USP-NF.

18. Are FCC Analytical Materials (FAMs) required for use with the FCC?

USP Reference Standards, FAMs, and analytical materials from third parties are all cited in the FCC as appropriate based on individual method needs. Please refer to the individual monograph or Appendix method of interest to determine whether a USP Reference Standard, FAM, or other test material is required.

19. What are the available FCC Analytical Materials (FAMs)?

USP offers a variety of FAMs. Visit our FAM Catalog page to browse and buy analytical materials, ask a technical question, find an account manager, and more.

20. What are the prices of FCC Analytical Materials (FAMs)?

Please visit our FAM Catalog page for more information.

21. If I have questions about FCC Analytical Materials (FAMS), who should I contact?

We can be contacted at FAMtech@usp.org.