Food Chemicals Codex

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The Food Chemicals Codex (FCC) is a collection of internationally recognized standards for the purity and identity of food ingredients.

Contents

Scope

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]

The FCC has two primary sections: monographs and appendices. Monographs are listed alphabetically and typically cover a single ingredient. Monographs, where applicable, provide information about each ingredient, such as: [1] [3]

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]

FCC standards are established, evaluated, and revised with scientific rigor in an open, collaborative process involving USP scientists, government representatives, expert volunteers, and public input. Standards are approved by an Expert Committee that includes knowledgeable technical leaders from industry, academia, and regulatory bodies from around the world. [4]

History

The FCC has been published since 1966.

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.

USP acquired the FCC in 2006. USP started the online version of the FCC since 2008. The FCC is published every two years in print and online formats and is offered as a subscription that includes a main edition and intervening supplements. All proposed standards and revisions for the FCC are first posted in the free, online FCC Forum for a 90-day public comment period. As of May 2021, the FCC has been reprinted twelve times. [6]

Editions

Latest edition (the twelfth edition)

FCC 12 has over 80 new and updated monographs compared to FCC 11.

More than 1,250 monographs including:

18 appendices, providing clear, step-by-step guidance for more than 150 tests and assays including:

First edition

The Food Protection Committee started in 1961 to provide objective quality standards for food-grade chemicals. Parts of the first edition were published in loose-leaf form between 1963 and 1966.

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]

Second edition

This edition, slightly larger than the first, contains 639 monographs. [7]

Third edition

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.

The monograph section previously entitled 'Specifications' has been changed to 'Requirements', and this also includes any identification tests that previously appeared under a 'Description' section.

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]

Fourth edition

Fifty-two new monographs are added to the third edition, making a total of 967 monographs.

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]

Sixth edition

This edition was the first under USP's direction. This edition contains more than 1,000 monograph standards and tests to assure the identity, quality and purity of food ingredients. [10]

Eighth edition

This authoritative edition provides:

This edition also features for the first time the complete contents of USP's upcoming Food Fraud Database. The database features more than 1,300 entries on adulterants reported for specific ingredients and the corresponding analytical detection method. Based on scholarly manuscripts and media articles from 1980-2010, it serves as a baseline on fraud issues and can be a useful risk management tool for industry, regulators and other stakeholders. [11]

Ninth edition

The ninth edition includes latest specifications for the identity and purity of about 1,200 food ingredients, including test methods and key guidance on critical issues.

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]

Fourteenth edition

As of mid-2024, the latest edition is the 14th.

Applications

The FCC is cited over 200 times in the U.S. Code of Federal Regulations and is recognized by regulatory bodies around the world including the US, Argentina, Australia, Brazil, Canada, Israel, New Zealand, Paraguay, and Uruguay. [4]

Relations

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. [13]

GRAS

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]

See also

Related Research Articles

<span class="mw-page-title-main">Food additive</span> Substances added to food

Food additives are substances added to food to preserve flavor or enhance taste, appearance, or other sensory qualities. Some additives have been used for centuries as part of an effort to preserve food, for example vinegar (pickling), salt (salting), smoke (smoking), sugar (crystallization), etc. This allows for longer-lasting foods such as bacon, sweets or wines. With the advent of ultra-processed foods in the second half of the twentieth century, many additives have been introduced, of both natural and artificial origin. Food additives also include substances that may be introduced to food indirectly in the manufacturing process, through packaging, or during storage or transport.

<span class="mw-page-title-main">E number</span> Codes for food additives

E numbers, short for Europe numbers, are codes for substances used as food additives, including those found naturally in many foods, such as vitamin C, for use within the European Union (EU) and European Free Trade Association (EFTA). Commonly found on food labels, their safety assessment and approval are the responsibility of the European Food Safety Authority (EFSA). The fact that an additive has an E number implies that its use was at one time permitted in products for sale in the European Single Market; some of these additives are no longer allowed today.

<span class="mw-page-title-main">Butylated hydroxytoluene</span> Chemical compound

Butylated hydroxytoluene (BHT), also known as dibutylhydroxytoluene, is a lipophilic organic compound, chemically a derivative of phenol, that is useful for its antioxidant properties. BHT is widely used to prevent free radical-mediated oxidation in fluids and other materials, and the regulations overseen by the U.S. F.D.A.—which considers BHT to be "generally recognized as safe"—allow small amounts to be added to foods. Despite this, and the earlier determination by the National Cancer Institute that BHT was noncarcinogenic in an animal model, societal concerns over its broad use have been expressed. BHT has also been postulated as an antiviral drug, but as of December 2022, use of BHT as a drug is not supported by the scientific literature and it has not been approved by any drug regulatory agency for use as an antiviral.

<span class="mw-page-title-main">Food coloring</span> Substance used to color food or drink

Food coloring, color additive or colorant is any dye, pigment, or substance that imparts color when it is added to food or beverages. Colorants can be supplied as liquids, powders, gels, or pastes. Food coloring is commonly used in commercial products and in domestic cooking.

Sodium stearoyl-2-lactylate is a versatile, FDA approved food additive used to improve the mix tolerance and volume of processed foods. It is one type of a commercially available lactylate. SSL is non-toxic, biodegradable, and typically manufactured using biorenewable feedstocks. Because SSL is a safe and highly effective food additive, it is used in a wide variety of products ranging from baked goods and desserts to pet foods.

The United States Pharmacopeia (USP) is a pharmacopeia for the United States published annually by the over 200-year old United States Pharmacopeial Convention, a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself.

<span class="mw-page-title-main">Generally recognized as safe</span> United States government designation for food additives

Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts under the conditions of its intended use. An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements. The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958, and all additives introduced after this time had to be evaluated by new standards. The FDA list of GRAS notices is updated approximately each month, as of 2021.

<span class="mw-page-title-main">Food Additives Amendment of 1958</span>

The Food Additives Amendment of 1958 is a 1958 amendment to the United States' Food, Drugs, and Cosmetic Act of 1938. It was a response to concerns about the safety of new food additives. The amendment established an exemption from the "food additive" definition and requirements for substances "generally recognized as safe" by scientific experts in the field, based on long history of use before 1958 or based on scientific studies. New food additives would be subject to testing including by the "Delaney clause". The Delaney clause was a provision in the amendment which said that if a substance were found to cause cancer in man or animal, then it could not be used as a food additive.

<span class="mw-page-title-main">Codex Alimentarius</span> Collection of internationally recognized standards

The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations published by the Food and Agriculture Organization of the United Nations relating to food, food production, food labeling, and food safety.

The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom. It is an annually published collection of quality standards for medicinal substances in the UK, which is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing.

<span class="mw-page-title-main">Psicose</span> Chemical compound

D-Psicose (C6H12O6), also known as D-allulose, or simply allulose, is a low-calorie epimer of the monosaccharide sugar fructose, used by some major commercial food and beverage manufacturers as a low-calorie sweetener. First identified in wheat in the 1940s, allulose is naturally present in small quantities in certain foods.

<span class="mw-page-title-main">Caramel color</span> Water soluble food coloring

Caramel color or caramel coloring is a water-soluble food coloring. It is made by heat treatment of carbohydrates (sugars), in general in the presence of acids, alkalis, or salts, in a process called caramelization. It is more fully oxidized than caramel candy, and has an odor of burnt sugar and a somewhat bitter taste. Its color ranges from pale yellow to amber to dark brown.

<span class="mw-page-title-main">Polyglycerol polyricinoleate</span> Emulsion used in food production

Polyglycerol polyricinoleate (PGPR), E476, is an emulsifier made from glycerol and fatty acids. In chocolate, compound chocolate and similar coatings, PGPR is mainly used with another substance like lecithin to reduce viscosity. It is used at low levels, and works by decreasing the friction between the solid particles in molten chocolate, reducing the yield stress so that it flows more easily, approaching the behaviour of a Newtonian fluid. It can also be used as an emulsifier in spreads and in salad dressings, or to improve the texture of baked goods. It is made up of a short chain of glycerol molecules connected by ether bonds, with ricinoleic acid side chains connected by ester bonds.

<span class="mw-page-title-main">Joint FAO/WHO Expert Committee on Food Additives</span>

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is an international scientific expert committee that is administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). It has been meeting since 1956 to provide independent scientific advice pertaining to the safety evaluation of food additives. Its current scope of work now also includes the evaluation of contaminants, naturally occurring toxicants and residues of veterinary drugs in food.

<span class="mw-page-title-main">Mono- and diglycerides of fatty acids</span> Emulsifier

Mono- and diglycerides of fatty acids (E471) refers to a naturally occurring class of food additive composed of diglycerides and monoglycerides used as an emulsifier in foods such as infant formula, fresh pasta, jams and jellies, chocolate, creams, baked goods, and more. It is also used as a fruit coating agent. This mixture is also sometimes referred to as partial glycerides.

Synthetic magnesium silicates are white, odorless, finely divided powders formed by the precipitation reaction of water-soluble sodium silicate and a water-soluble magnesium salt such as magnesium chloride, magnesium nitrate or magnesium sulfate. The composition of the precipitate depends on the ratio of the components in the reaction medium, the addition of the correcting substances, and the way in which they are precipitated.

Lactylates are organic compounds that are FDA approved for use as food additives and cosmetic ingredients, e.g. as food-grade emulsifiers. These additives are non-toxic, biodegradable, and typically manufactured using biorenewable feedstocks. Owing to their safety and versatile functionality, lactylates are used in a wide variety of food and non-food applications. In the United States, the Food Chemicals Codex specifies the labeling requirements for food ingredients including lactylates. In the European Union, lactylates must be labelled in accordance with the requirements of the applicable EU regulation. Lactylates may be labelled as calcium stearoyl lactylate (CSL), sodium stearoyl lactylate (SSL), or lactylic esters of fatty acids (LEFA).

Calcium stearoyl-2-lactylate or E482 is a versatile, FDA approved food additive. It is one type of a commercially available lactylate. CSL is non-toxic, biodegradable, and typically manufactured using biorenewable feedstocks. Because CSL is a safe and highly effective food additive, it is used in a wide variety of products from baked goods and desserts to packaging.

<span class="mw-page-title-main">Ethane-1,1-dithiol</span> Chemical compound

Ethane-1,1-dithiol is an organosulfur compound with formula CH3CH(SH)2. It is a colourless smelly liquid that is added to or found in some foods. The compound is an example of a geminal dithiol.

<i>N</i>,<i>N</i>-Dimethylphenethylamine Chemical compound

N,N-Dimethylphenethylamine (N,N-DMPEA) is a substituted phenethylamine that is used as a flavoring agent. It is an alkaloid that was first isolated from the orchid Eria jarensis. Its aroma is described as "sweet, fishy". It is mainly used in cereal, cheese, dairy products, fish, fruit and meat. It is also being used in pre-workout and bodybuilding supplements with claims of a stimulant effect.

References

  1. 1 2 3 4 U.S. Pharmacopeial Convention. "Food Chemicals Codex (FCC)". Archived from the original on 4 December 2015. Retrieved 6 December 2015.
  2. ↑ Natural Products Insider. "New Edition of Food Chemicals Codex Offers New Monographs, Quality Standards". Archived from the original on 28 April 2017. Retrieved 6 December 2015.
  3. 1 2 Perfumer & Flavorist. "6th Edition of Food Chemical Codex Now Open-Source" . Retrieved 6 December 2015.
  4. 1 2 3 "Food Chemicals Codex (FCC) | FCC | Online". www.foodchemicalscodex.org. Retrieved 21 November 2020.
  5. 1 2 Read "Food Chemicals Codex: First Edition" at NAP.edu. Washington, DC: The National Academies Press. 1966. p. 13-14. Retrieved 21 November 2020.
  6. ↑ "Impact of Extended Implementation on FCC Platform Starting on December 1, 2020 until June 1, 2021 | FCC | Online". www.foodchemicalscodex.org. Retrieved 21 November 2020.
  7. ↑ "Food chemicals codex, second edition. Prepared by the Committee on Specifications, Food Chemicals, Codex, of the Committee on Food Protection, National Research Council, National Academy of Sciences, 2101 Constitution Ave., N.W., Washington, DC 20418, 1972. 1039 pp. 15 × 23 cm. Price $20.00". Journal of Pharmaceutical Sciences. 62 (2): 347–348. 1973. doi: 10.1002/jps.2600620247 . ISSN   1520-6017 . Retrieved 21 November 2020.
  8. ↑ "Food Chemicals Codex: Food Chemicals Codex 3rd Ed. Committee on Codex Specifications, Food and Nutrition Board, Division of Biological Sciences, Assembly of Life Sciences, National Research Council. National Academy Press, Washington, DC, 1981. pp. xxxi + 735, $45.00". Food and Chemical Toxicology. 20 (2): 231–232. 1 April 1982. doi:10.1016/S0278-6915(82)80257-3. ISSN   0278-6915 . Retrieved 21 November 2020.
  9. ↑ Birch, G. (1 May 1997). "Food chemicals codex: Institute of Medicine of the National Academy of Sciences, 1996 (4th edn). ISBN 0 309 05394 3. xxxii + 882 pp". Food Chemistry. 59 (1): 179–180. doi:10.1016/S0308-8146(97)86708-8. ISSN   0308-8146 . Retrieved 21 November 2020.
  10. ↑ "U.S. Pharmacopeia Releases New Edition of the Food Chemicals Codex". Science Letter: 514. 18 March 2008. Retrieved 21 November 2020.
  11. ↑ "-USP - New Edition of Food Chemicals Codex Offers Standards to Help Ensure Quality, Purity of Innovative and Widely Used Ingredients". ENP Newswire. 8 March 2012. Retrieved 21 November 2020.
  12. ↑ "Gale General OneFile - Document - New edition of the Food Chemicals Codex". go.gale.com. Attwood & Binsted Ltd. Retrieved 21 November 2020.
  13. ↑ "FAQs: Food Chemicals Codex (FCC) | USP". www.usp.org. Retrieved 21 November 2020.
  14. ↑ Nutrition, Center for Food Safety and Applied (11 February 2020). "How U.S. FDA's GRAS Notification Program Works". FDA. Retrieved 21 November 2020.
  15. ↑ "FCC Publication and Comment Schedule | FCC | Online". www.foodchemicalscodex.org. Retrieved 21 November 2020.
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