Food Chemical Codex 7th Edition Free Download Pdf

The FCC features more than 1,250 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). The FCC also contains ingredients, such as sucrose and essential oils, that are not frequently found in other food additive standards resources.[1][2]

The FCC provides essential criteria and analytical methods to authenticate and determine the quality of food ingredients. FCC standards are used as agreed standards between suppliers and manufacturers in ongoing purchasing and supply decisions and transactions. [1][3]

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There are also several "family" monographs, which cover substance groups. These include "Enzyme Preparations," "Food Starch," and "Spice Oleoresins." Additionally, specifications are included, consisting of a series of tests, procedures for the tests, and acceptance criteria. Monographs may also detail USP Reference Standards and/or other materials needed for test performance. The FCC's appendices contain step-by-step guidance for general physical and chemical tests, and apparatus use, as well as generally useful information, such as food ingredient good manufacturing practices.[1]

Before 1960s, although the federal Food and Drug Administration (FDA) had by regulations and informal statements defined in general terms quality requirements for food chemicals generally recognized as safe (GRAS), these requirements were not published in the official regulations or designed to be sufficiently specific, therefore their use for general guidance was restricted.For these and other reasons, the Food Protection Committee of the National Academy of Sciences-National Research Council received requests in 1958 from its Industry Liaison Panel and other sources to undertake a project designed to produce a Food Chemicals Codex comparable in many respects to the United States Pharmacopeia (USP) and the National Formulary (NF). In response to these requests, advice was sought from special committees composed of representatives of industry, government agencies, and others experienced in the operation of the USP and the NF.[5] As a result, in 1966, This first edition of the FCC was published by the Institute of Medicine (IOM) for FDA.

The scope of the first edition is limited to substances amenable to chemical characterization or biological standardization which are added directly to food to perform some desired function. Such substances were selected from food additives generally recognized as safe, those approved by prior sanctions, and those for which special use tolerances have been established by FDA regulations.[5]

The specifications in this edition of FCC were officially recognized not only by the FDA but also, under certain conditions, by the Canadian, Australian, New Zealand and UK authorities. This edition shows substantial differences in format from its 9-year-old predecessor, including much larger pages and two-column layout. The addition of 113 new monographs brings the total number to 776, covering over 800 substances. For the first time these include materials such as dextrose and fructose, more generally regarded as foods than as additives. Only one monograph, for aluminium sulphate solution, has been deleted because it appears to be no longer used in foods.

Other changes in this edition are the inclusion for the first time of general Good Manufacturing Practices (GMP) guidelines for food chemicals, and the abandonment of a previous policy whereby the specifications for individual substances applied also to mixtures of the primary substance with additives such as anticaking agents, antioxidants and emulsifiers.[8]

In the course of the four editions, FCC has been expanded to include not only food additives, but also substances that come into contact with food and substances that are food (e.g. fructose and dextrose). However, three previous monographs have now been deleted (i.e. carrageenan, cinnamyl antranilate and methyl formate) due to altered circumstances and special emphasis is now placed on reducing contaminants, particularly lead.[9]

Among the new monographs in the FCC is spirulina, a food ingredient that was just recently[when?] approved as a natural source of blue colour for candy and chewing gum by the US FDA. Formulators also use spirulina in specialty food bars, powdered nutritional drinks, among other products due to its non-animal protein content.

Another monograph included in this edition of FCC is brilliant black PN, a synthetic food colour used in products requiring the colour black in their formulation (jams, chocolate syrup and candy are common examples). Even though the FDA has not approved brilliant black PN as a food colour in the USA, its use in food is currently approved in many other countries.[12]

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. [13]

As a list of food substances not requiring a formal premarket review by FDA to assure their safety, GRAS list is directly regulated and updated by FDA.By 1997 FDA had tentatively concluded that it could no longer devote substantial resources to the GRAS affirmation petition process. As a result, FDA launched the GRAS Notification Program so as to update the list.[14] FCC standards are reviewed and approved by independent experts. All proposed standards and revisions for the FCC are first posted in the free, online FCC Forum for a 90-day public comment period.[15]

The FCC and associated Reference Materials enables you to verify the identity, quality, and purity of the food ingredients you buy and sell, which help to ensure the overall safety and integrity of the food ingredient supply chain. An FCC standard can be used to characterize ingredients used in food. Monographs in the FCC consist of tests and specifications for identification, assay and impurities, as well as other tests that help describe the purity and quality of the ingredient. FCC standards are reviewed and approved by independent experts. Learn how to become an expert volunteer.

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).

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.

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..

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.

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. 2351a5e196