Monographs, Codex Specifications

Food Chemicals Codex specifications, comprising the Description, Requirements, and Tests, are presented in monograph form (Section 2) or tabular form (Section 3) for each substance or group of related substances. They are designed to ensure that food additives have a sufficiently high level of... 

Allergens The Committee on Food Chemicals Codex recognizes the issue of food allergens, but current limitations regarding (1) the threshold levels and (2) the analytical methods to detect allergens at very low levels have thus far prevented the inclusion in FCC monographs of specifications related to allergens. 

Note Suitable detector tubes are available from National Draeger, Inc., P.O. Box 120, Pittsburgh, PA 15205-0120. Tubes other than those specified in the monograph may be used in accordance with the section entitled Codex Specifications in the General Provisions. 

Purity criteria are published by JECFA as well as by national authorities. The JECFA specifications33 may be endorsed by the Codex Alimentarius as advisory specifications which means that they are equivalent to a Codex Alimentarius standard. In the EU a directive laying down special criteria of purity for sweeteners for use in foodstuffs with subsequent amendments sets the purity standards,31 while in the USA criteria may be listed in conjunction with the approval. Normally a monograph of the Food Chemicals Codex34 is considered the applicable basis for assessment of purity. 

While the above EU Directive lists the criteria only, the JECFA specifications refer to analytical methods in a Guide to Specifications35 or describe the analytical method in the specification monograph itself. Similarly, the Food Chemicals Codex lists and describes the necessary analytical methods for purity control. 

Several officially recognized compendia describe specifications for components and finished product (e.g., U.S. Pharmacopeia, Food Chemicals Codex, British Pharmacopeia, and European Pharmacopeia). These specifications have been established by an advisory board to each compendium and represent the views of many manufacturers and government based on a history of the component or product. Such specifications are reviewed and updated as the need arises when new information becomes available. These compendia are very useful and should always be used as a guide whenever possible. In the case of the USP, for example, if a monograph exists for a component or product, U.S. drug manufacturers are required to satisfy those specifications as a minimum requirement. 

The titles of FCC monographs are in most instances the common or usual names. The FCC specifications apply equally to substances bearing the main titles, synonyms listed under the main titles, and names derived by transposition of definitive words in main titles. The Committee on Food Chemicals Codex recognizes that the nomenclature used for flavor chemicals may not be consistent with other authoritative sources. 

Heavy Metals Limits (Policy) The Committee on Food Chemicals Codex notes the importance of providing limits for individual heavy metals as required by the source and composition of individual food additives. Thus, it has decided to remove from most monographs the general heavy metals (as lead) limits and tests and, based on the current level and availability of scientific information and on the policy stated below, to replace them with limits and tests for specific heavy metals such as lead, cadmium, and mercury as may be relevant to each substance. 

The USPNF 23 also includes a monograph for xanthan gum solution. A specification for xanthan gum is contained in the Food Chemicals Codex (FCC). 

Specifications for food chemicals are to be found in the Food Chemicals Codex (17). This compendium is prepared by the Food and Nutrition Board of the National Research Council. It contains monographs of many food chemicals and is recognized by the Food and Drug Administration as defining their "appropriate food grade" within the meaning of FDA regulations (12,18). 

Deutscher Arzneimittel-Codex/Neues Rezeptur-Formularium (DAC/NRF) is a German collection of general information about specification and identification of substances, pharmacy preparation and quality control, monographs of substances and formulas including preparation methods. 

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