Frequently Asked Questions: Food Chemicals Codex (FCC)
- What is the FCC?
- Why is the FCC important?
- How can I subscribe to the FCC?
- What is USP's role in the FCC?
- What data do I need to get a new ingredient listed in the FCC or modify an existing monograph?
- What is the FCC Forum?
- Is a subscription required to access the FCC Forum?
- How does the FCC relate to JECFA?
- What is the difference between the FCC and GRAS?
- What benefits can I obtain from the use of USP Reference Standards in FCC methods?
- Where can I buy FCC Reference Standards?
- What are the effective dates for the FCC and its Supplements?
- Where can I learn more about the Food Ingredients Expert Committee?
- What is in the Ninth Edition?
- Is FCC available online?
- How can I learn more about the FCC?
The FCC is a compendium of internationally recognized standards for the purity and identity of food ingredients. It features over 1,200 monographs, including food-grade chemicals, processing aids, foods (such as vegetable oils, fructose, whey, and amino acids), flavoring agents, vitamins, and functional food ingredients (such as lycopene, olestra, and short chain fructooligosaccharides).
Food production, from "farm to fork" is a long, ever more globalized, complicated process, and potential vulnerabilities regarding the integrity of food ingredients are increasingly scrutinized by government, retailers, and consumers. FCC plays a key role in two ways: by helping to limit the introduction of potential problems at the ingredients level, as well as by being a widely acknowledged yardstick in the daily interactions of buying and selling food ingredients in the global marketplace. FCC standards are recognized around the world by regulatory agencies, food processors, and ingredients suppliers.
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.
The FCC was published by the Institute of Medicine from 1966 to 2006. In August 2006, publication of the FCC was assumed by USP. 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.
USP is ideally suited to ensure an orderly, timely, and transparent scientific process for food ingredient standards. USP's well–established revision structure promotes the appropriate stakeholder participation and input, while ensuring the integrity and objectivity of the standards–setting processes.
Visit Submit FCC Monographs and Revisions for details.
Changes and additions to the FCC are generally first proposed in the FCC Forum, an online service where public comments are invited. The forum, which is free and open to everyone, also includes information about submitting comments and providing input. 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 by a group of independent and established scientific experts: the Food Ingredients Expert Committee. The FCC Forum is a twice–a–year event: going live June 30 and December 31. Both FCC Forums have 90–day comment periods.
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.
The FCC and standards from the Joint FAO/WHO Expert Committee on Food Additives (JEFCA) are both used throughout the world. The FCC supports ingredients that are not considered by JECFA–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 JECFA are soybean oil, sucrose, fructose, and sodium chloride–substances considered by JECFA to be both foods and 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 latter as a provisional FCC monograph until a regulatory decision has been sought and made). The broader range of ingredients supported by the FCC provides a compendium for the food industry that is often more comprehensive and more useful.
A GRAS (Generally Recognized as Safe) dossier relates more to safety for intended use. The FCC focuses on specifications and analytical methodology. Unlike a GRAS dossier, there is NO COST for an FCC monograph to be developed and submitted to USP and the Food Ingredients Expert Committee. In fact, USP staff scientists will work closely with monograph sponsors to prepare a proposed monograph and guide it expeditiously through the public FCC Forum and Food Ingredients Expert Committee decisions. Suppliers with self–determined GRAS'd substances, for example, reference FCC monographs and methods as a third–party, independent source for their customers.
The combination of reference standards and FCC monographs assists the food industry and analytical community in many ways:
Increased safety of food ingredients: Stringent identity criteria in the FCC monograph, together with a reference material (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. The analytical results of FCC reference materials permit side–by–side comparison of this authentic sample against any unknown material thereby aiding in excluding the presence of adulterating substances.
Protection of the identity of food ingredients: Food ingredient producers that sponsor the development of a monograph and reference materials will enjoy additional protection of the authenticity of their product by always having an authentic sample publicly available. This authentic sample will allow any customer (prospective or current) in the supply chain to evaluate their own material for purity and authenticity, and thus increase the trust and safety in a food ingredient that is supported in such a transparent way.
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 will increase the reliability of analytical test procedures, aid in quality audits, and generally enhance the level of confidence in the test results.
USP offers a wide variety of Reference Standards. The latest USP Catalog features more than 3,100 items. For food-specific reference materials only, click here.
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.
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
The FCC 9th Edition contains more than 1,200 monographs featuring the following key specifications: empirical formula; structural formula; formula weight; CAS, INS, and FEMA numbers description, including physical form and solubility function; identification; assay; impurity limits; and specific tests packaging and storage; and more.
A sample FCC monograph can be viewed here.
The FCC 9th Edition also contains 15 appendices providing clear, step-by-step guidance for more than 150 tests and assays; Helpful information and guidance: Validation of Food Chemicals Codex Methods; AOAC/ISO/IUPAC guidelines on method validation; USP Reference Standards for food ingredients; Information on analytical techniques from USP–NF General Chapters, IR spectra; General Good Manufacturing Practices (GMP) Guidelines for Food Chemicals; Comparison of GMP elements from foods and drugs; and FCC specifications required in the U.S. Code of Federal Regulations; 2,000+ entries excerpted from the USP Food Fraud Database featuring information on adulterants reported for specific ingredients, including analytical methods. Based on scholarly manuscripts and media articles from 1980–2010, the database serves as a baseline on fraud issues and is a useful risk management tool.
The FCC 9th Edition is an essential reference for food and beverage manufacturing, food chemicals and ingredient supply chain management, quality control, and regulatory affairs. It provides accepted standards that include validated methods with the associated specifications—use them with global partners to manage your supply chain. FCC 9th Edition standards can help differentiate suppliers and can help manufacturers save time and money on day-to-day purchasing and transactions.
With the ninth edition, FCC introduced a new online format with these convenient features:
- Same quality content found in the print version
- Keyword and advanced search functionality
- Bookmarking, copying, and pasting, among other user–friendly features
- Password accessibility from any computer, 24 hours a day