PREFACE
The Fifth Edition of the Food Chemicals Codex (FCC) is a result of the collective efforts of the many members, past and present, of the Committee on Food Chemicals Codex over the past 42 years. The current committee, whose members have brought all these efforts to fruition with this edition, was appointed following a request from the U.S. Food and Drug Administration (FDA) to continue this activity. The charge to the committee states that "the committee shall (1) provide information on matters related to the purity of food ingredients used in the United States and shall be knowledgeable of the purity of food ingredients used in other countries; (2) provide information on food-grade specifications for food additives, GRAS [generally recognized as safe] substances, and any other food substances used as ingredients; and (3) publish specification monographs in a Fifth Edition of the Food Chemicals Codex. To provide such information, the committee shall review proposals from industry, government, and any other source.’’
The FCC project, currently under the Food and Nutrition Board of the Institute of Medicine of the National Academies, began in 1961, soon after the passage of the 1958 Food Additives Amendment to the federal Food, Drug, and Cosmetic Act. Although the FDA had, by regulations and informal statements, defined in general terms the quality requirements for GRAS and other food chemicals, these requirements were not sufficiently specific to serve as release, procurement, and acceptance specifications for manufacturers and users of food chemicals. Therefore, regulators and other interested parties believed that the publication of a book of standards designed especially for food chemicals would promote uniformity of quality and added assurance of safety for such chemicals. For these 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 to produce a Food Chemicals Codex comparable in many respects to the United States Pharmacopeia and the National Formulary for drugs. As a result of these requests, representatives of industry and government agencies agreed that there was a definite need for such a Codex and that the Food Protection Committee was a suitable body to undertake the project.
The first edition, published in 1966, was supported by a Public Health Service grant and more than 100 supplementary grants from industry, associations, and foundations. Its role, which is still that of the Food Chemicals Codex, was to define the quality of food-grade chemicals in terms of identity, strength, and purity based on the elements of safety and good manufacturing practice. Later editions were supported by direct contracts with the FDA. Such sponsorship has been sufficient to support the publication of 4 earlier editions and 14 supplements in a 42-year span.
SCOPE
The scope of the Food Chemicals Codex has expanded with each new edition. Substances included in the first edition were limited to chemicals added directly to foods to achieve a desired function. Succeeding editions included these substances as well as such processing aids as enzymes, extraction solvents, filter media, and boiler water additives; those that are regarded as foods, such as fructose and dextrose, rather than as additives; and those that exhibit a functional effect, not on the foods to which they are added, but to the human body when the food is consumed. This Fifth Edition includes 961 monographs from the Fourth Edition; 49 monographs, along with those for 15 flavor chemicals, added in the three supplements to the Fourth Edition; and 19 new monographs, along with 33 for flavor chemicals, new to this Fifth Edition, bringing the total to 1077. Because of its regulatory status in countries other than the United States, and its worldwide use, the Food Chemicals Codex contains some monographs for chemicals not currently allowed in foods in the United States. This circumstance is clearly indicated in such monographs.
UPDATING AND DEVELOPING SPECIFICATIONS
The committee has invariably sought to define, using physicochemical and microbiological parameters, ingredients prepared under good manufacturing practices as safe for human consumption. Special emphasis has been placed on reducing contaminants, including trace elements, particularly lead. The committee removed Arsenic and Microbiological Criteria specifications from monographs that were unnecessarily burdened with them. More importantly, the committee revised the Lead and Heavy Metals Limits Policy by removing the Heavy Metals (as Pb) specifications and replacing them with specifications for relevant heavy metals. The committee also decided, based on research of the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine, the National Academies, that the intake of fluoride as a constituent of substances described in FCC monographs is not expected to significantly add to the human daily fluoride intake. However, because high levels of fluoride have been amply demonstrated to cause toxicological problems, as described in the report, the maintenance of fluoride limits in selected food additives appears consistent with sound public health policy. Because of the difficulties in analyzing for fluoride in food chemicals, the committee has adopted a new analytical method for fluoride and will continue to add more when adequate validation of new methods is submitted.
Limits on contaminants, specifically lead and other heavy metals, have been reduced in most monographs in this edition. This trend is expected to continue. Manufacturers and suppliers of food ingredients are encouraged to inform the committee of their ability to supply food ingredients with lead and other heavy metals limits lower than those specified in this edition. The arsenic specification remains in relatively few monographs in this edition where (1) the ingredient or additive is a high-volume consumption item (greater than 25 million pounds a year), (2) the ingredient or additive is derived from a natural (mineral) source where arsenic may be an intrinsic contaminant, or (3) there is reason to believe that arsenic constitutes a significant part of the total heavy metals content.
The committee is cognizant of the need for international harmonization of specifications in today’s world. Efforts were made, where feasible, to harmonize the specifications in this edition with those of other standards-setting organizations, in particular with those in the Compendium of Food Additive Specifications, prepared by the Food and Agricultural Organization of the United Nations (FAO)/World Health Organization (WHO) Joint Expert Committee on Food Additives (JECFA) and published by the FAO.
FORMAT
Generally the presentation follows that of the Fourth Edition, but a number of significant changes and additions have been made. As expected, the passage of 7 years since the appearance of the Fourth Edition has been accompanied by changes:
--Additional information in terms of FEMA (Flavor and Extract Manufacturers Association) numbers has been added to essential oil and other flavor monographs not in the Flavors Table, Chapter 3.
-- Infrared Spectra for most substances requiring them for identification purposes have been rerun and thus are more accurate.
--New headers on each page of this book tell readers where they are by chapter, monograph, appendix, or test.
--The language in the monograph section has been revised to be more clear, consistent, and concise.
--All tests that occurred identically in three or more monographs were moved to the appendices.
FUTURE REVISIONS
The introduction of new food additives as well as constant changes and advances in manufacturing processes and analytical sciences lead to a need for continued revision of this compendium.
The committee recognizes the need to initiate an extensive update of the analytical methods described in this edition, in such a way that advanced new technologies are incorporated in the Sixth Edition, while maintaining a balance with other, less technology-intensive methods for use by laboratories and firms that may not have access to such advanced technology. The committee specially recognizes the urgency of updating current chromatographic methods throughout the present edition and intends to complete this goal during the next 5 years. Users of this edition are requested and encouraged to submit suggestions for updating the specifications as well as the general analytical methods. Constructive criticism and notification of errors should also be brought to the attention of the Food Chemicals Codex, Institute of Medicine, 500 Fifth Street, N.W., Washington, D.C. 20001 or fcc@nas.edu.
LEGAL STATUS
The Food Chemicals Codex has earned international recognition by manufacturers, vendors, and users of food chemicals. The specifications herein serve as the basis for many buyer and seller contractual agreements.
In the United States, the first edition was given quasi-legal recognition in July 1966 by means of a letter of endorsement from FDA Commissioner James L. Goddard, which was reprinted in the book. The letter stated that ‘‘the FDA will regard the specifications in the Food Chemicals Codex as defining an ‘appropriate food grade’ within the meaning of Sec. 121.101(b)(3) and Sec. 121.1000(a)(2) of the food additive regulations, subject to the following qualification: this endorsement is not construed to exempt any food chemical appearing in the Food Chemicals Codex from compliance with requirements of Acts of Congress or with regulations and rulings issued by the Food and Drug Administration under authority of such Acts.’’
Subsequently, the specifications in the Second Edition, followed by those in the Third Edition, were cited, by reference, in the U.S. Code of Federal Regulations to define specific safe ingredients under title 21, in various parts of sections 172, 173, and 184.
In Canada, the current edition of the Food Chemicals Codex, including its supplements, is officially recognized in the Canadian Food and Drug Regulations under Section B.01.045(b) as the reference for specifications for food additives. The new Australia New Zealand Food Authority recognizes the Food Chemicals Codex as a primary source of identity and purity specifications in its Food Standards Code, Chapter 1 General Food Standards, Part 1.3 Substances Added to Food, Standard 1.3.4 Identity and Purity.
REVIEWERS
This report has been reviewed in draft form by inpiduals chosen for their perse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following inpiduals for their review of this report:
William E. Artz, University of Illinois
James N. Bemiller, Purdue University
Rengaswami Chandrasekaran, Purdue University
Sam Chang, North Dakota State University
Susan L. Cuppett, University of Nebraska
Stephanie Doores, University of Pennsylvania
William Eigel, Virginia Polytechnic and State University
Ronald Eitenmiller, University of Georgia
Jeffrey M. Farber, Health Canada
Harold R. Faust, Penreco
Kenneth Fowkes, Praxair Distribution Inc.
Earl Hammond, Iowa State University
Donald L. Johnson, Consultant
Paul Lachance, Rutgers University
John Lichtfield, The Ohio State University
Harold M. McNair, Virginia Polytechnic and State University
Dennis D. Miller, Cornell University
David B. Min, The Ohio State University
Sean O’Keefe, Virginia Polytechnic and State University
Andrew Proctor, University of Arkansas
Jenny Scott, National Food Processors Association
Randy Wehling, University of Nebraska
Ronald Wrolstad, Oregon State University
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Barbara P. Klein, University of Illinois. Appointed by the National Research Council and Institute of Medicine, she was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.
ACKNOWLEDGMENTS
A compendium of this breadth can only result from the cooperation of many inpiduals and organizations. Underlying this, the support provided by FDA contract number 223-99-2321, monitored by project officers Paul M. Kuznesof and Daniel Folmer, is gratefully acknowledged.
Several monographs and various sections in this edition have portions based on other publications, and are used with permission granted by the parent organizations: the American Chemical Society; the American Oil Chemists Society; the American Society for Testing and Materials; AOAC International; and the United States Pharmacopeial Convention, Inc. This edition of the Food Chemicals Codex directly references the procedures in the Eighth Edition of the FDA Bacteriological Analytical Manual (BAM) for its microbial limit tests. Where the sample size is not defined in the limit, the results are based on the sampling procedures described in BAM.
While participating inpiduals have been listed on pages vii–ix, the following organizations have also been active participants:
American Dairy Products Institute
Corn Refiners Association
Enzyme Technical Association
Flavor and Extract Manufacturers Association
Gelatin Manufacturers of Europe
Gelatin Manufacturers Institute of America
International Association of Color Manufacturers
International Dairy Federation
International Food Additives Council
International Pectin Producers Association
International Pharmaceutical Excipients Council
International Technical Caramel Association
National Association of Chewing Gum Manufacturers
Salt Institute
Soy Protein Council
Members of the National Academies Press—Sally S. Stanfield, James M. Gormley, Estelle H. Miller, Dan Parham, and William B. Mason—and staff of the Institute of Medicine Office of Reports and Communication—Jennifer Bitticks, Jennifer Otten, Bronwyn Schrecker, and Leah Covington—provided valuable support to the FCC staff toward the publication of this edition.
Success in the complex task of completing the Fifth Edition is due to the dedication and determination of the members of the Committee on Food Chemicals Codex under the focused leadership of its successive chairs, Steve L. Taylor and S. Suzanne Nielsen, during the past 58 months, and to those of the Food Chemicals Codex staff, Maria Oria and Marcia Lewis.
Washington, D.C. Ricardo A. Molins
September 2003 Study Director
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