Food Chemicals Codex (FCC)
The FCC is a compendium of internationally recognized standards for the purity and identity of food ingredients. It features about 1,100 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).
FCC establishes, with public and stakeholder guidance, internationally recognized scientific standards for identity and purity of food ingredients and supporting test procedures. FCC allows ingredients buyers and sellers to work together more efficiently and cost effectively with standards that are recognized and accepted around the world. These standards have been created and vetted by a highly rigorous and transparent scientific process. A new edition of the FCC will be released every two years, with Supplements published between each edition.
Food production, from "farm to fork" is a long, increasingly globalized, complicated process, and the vulnerabilities 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.
The FCC is a proven tool in establishing and managing quality–key elements in facilitating vendor and customer relationships.
The FCC was published by the Institute of Medicine from 1966 to 2006. In August 2006, publication of the FCC was assumed by USP. As the official standards–setting body for pharmaceuticals, pharmaceutical ingredients, and dietary supplements, 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.
USP's nearly 200–year history, reputation, and independence will ensure continuity of the FCC. USP has instituted a biennial cycle for new editions of the FCC, with Supplements in interim years. This is important because food scientists will have full and regular access to both the latest science and the revision process. Plus, an online public notice and comment process for revision proposals is available in the FCC Forum.
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–affirmed 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.
FCC monographs can be stepping–stones for JEFCA reviews. The process by which JECFA evaluates new food ingredients is complex, and competitive, and many ingredients (and their corporate or country sponsors) are now in the queue. Having a quality monograph, reviewed by the Food Ingredients Expert Committee and published in the FCC, may aid a sponsor in obtaining priority for JECFA's review.
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 the document 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 monograph, together with 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 reference materials permit side–by–side comparison of this authentic material and any unknown material as a way to confirm the unknown material's identity and aid in excluding the presence of adulterating agents.
- 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) to evaluate any other 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.
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 the United States Pharmacopeia and the National Formulary (USP–NF), the legally recognized standards compendia for drugs, drug products, and dietary supplements; in the FCC; and in other related publications.
Members of the Council of Experts and the Food Ingredients Expert Committee develop and review monographs, General Chapters, and test methods; they also collaborate on scientific topics supporting the standards that appear in USP's compendia.
With the sixth edition, FCC had a new look and new organization: flavor chemicals moved to the alphabetical monograph section, IRR Spectra also moved into their respective monographs, tests and assays for regular and flavor chemical monographs were placed together in the Appendices. Chemical structures were redrawn; monographs were reorganized and the result was a redesign that has allowed quicker and easier access to the needed information. Finally, a new, online version was introduced.
With the Seventh edition other additions and changes are added:
- Effective date added to all monographs
- Informational sections added to the appendices:
- USP Reference Standards for Food Ingredients
- A compare–and–contrast table of GMP elements for Foods, Dietary Supplements, and Drugs
- Listing of FCC in the U.S. Code of Federal Regulations
- Selected sections from USP–NF General Chapters, as for user introductions: Electrophoresis, Capillary Electrophoresis, Mass Spectrometry, Nuclear Magnetic Resonance, Radioactivity, Spectrophotometry and Light–scattering Ion Chromatography, NIR Spectroscopy, Raman Spectroscopy, Alcoholometric Table, Atomic Weights, Relative Atomic Mass and Half–Lives of Selected Radionuclides, Thermometric Equivalents
- AOAC/ISO/IUPAC guidelines on method validation
- Appendix of IR spectra
- Printable PDF pages for online version
With the sixth edition, FCC introduced a new online format with these convenient features:
- Same quality content found in the print version
- Keyword and advanced search functionality
- User–friendly features, such as bookmarking, and copy and pasting
- Password accessibility from any computer, 24 hours a day