Food Chemicals Codex

1013 Pages·2010·20.32 MB·English

SEVENTH
EDITION
FOOD CHEMICALS CODEX
FCC 7
By authority of the United States Pharmacopeial Convention.
Prepared by the Council of Experts and published by the
Board of Trustees
THE UNITED STATES PHARMACOPEIAL CONVENTION
12601 Twinbrook Parkway, Rockville, MD 20852
FCC 7 Preface / v
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FCC 7
This section provides general information about the Seventh contains monographs for ingredients that may not be
Edition of the Food Chemicals Codex (FCC) and background currently marketed in the United States.
information on the United States Pharmacopeial Convention USP acquired FCC from the NAS in 2006 and assumed
(USP). Additional information about the specific uses of this responsibility for its ongoing development and publication.
compendium is provided in the General Provisions (page 1). To continue the work of the Food and Nutrition Board of
IOM, USP formed a Food Ingredients Expert Committee
MISSION within its Council of Experts. This Expert Committee is
responsible for approving all new and revised standards in
FCC is published in continuing pursuit of the mission of USP:
FCC.
To improve the health of people around the world through
public standards and related programs that help ensure the
FCC 7
quality, safety, and benefit of medicines and foods.
The Seventh Edition of FCC (FCC 7) includes more than
HISTORY 1,100 monographs. It also contains more than 150 General
Tests and Assays, providing procedures frequently cited in
FCC began after the passage of the 1958 Food Additives
monographs, sometimes with acceptance criteria, in order
Amendment to the US Federal Food, Drug, and Cosmetic
to avoid repetition of this text. Additionally, FCC 7 offers a
Act. Although the Food and Drug Administration (FDA)
chapter with up-to-date relevant informational materials on
had, by regulations and informal statements, defined in
method validation and various analytical techniques,
general terms the quality requirements for food additives,
reference tables and information on current Good
food colors, substances generally recognized as safe for use
Manufacturing Practices. Additions, deletions and other
in foods (GRAS) and other food chemicals in the US market
revisions of text from the FCC Sixth Edition are indicated on
prior to 1958 (prior-sanctioned articles), these requirements
page xix in the Admissions section. The text of FCC 7 is
were not sufficiently specific to serve as release,
effective 90 days after the official date of publication, unless
procurement, and acceptance specifications for
otherwise noted.
manufacturers and users of food chemicals. Therefore,
regulators, industry and other interested parties recognized
Monograph Elements
the need for a compendium of standards designed
Each FCC 7 monograph represents the documentary stan-
especially for food chemicals, comparable to the United
dard for an article, manifested by specifications that speak
States Pharmacopeia for drugs and the National Formulary for
to the quality and safety of the food ingredient. Each mon-
excipients, which would define the quality of food-grade
ograph includes, when available, the following: empirical
chemicals in terms of identity, strength, and purity. The
formula, structural formula, and formula weight; description
National Academy of Sciences (NAS) was requested to
of the substance, including physical form, odor (flavoring
develop this compendium and published the first edition of
agents only), and solubility (see the descriptive terms for
the FCC in 1966. Subsequent editions were published by
solubility in the General Provisions); function; packaging and
the NAS in 1972, 1981, 1996, and 2003, through the Food
storage; labeling; identification; assay (or a quantitative test
and Nutrition Board of the Institute of Medicine (IOM),
to serve as an assay); impurities (inorganic and organic);
which formed a Committee on Food Chemicals Codex to
specific tests; and other requirements. The specifications
elaborate the FCC.
provided, taken together, represent a compositional under-
The scope of FCC has expanded with each new edition.
standing of the substance.
Substances included in the first edition were limited to
chemicals added directly to foods to achieve a desired
PUBLICATION OF FCC REVISIONS
function. Subsequent editions added: (a) processing aids
such as enzymes, extraction solvents, filter media, and boiler FCC revisions are published biennially in new editions, in
water additives; (b) foods, such as fructose and dextrose; Supplements published in intervening years and, when
and (c) functional ingredients that affect not the foods to circumstances warrant, as Expedited Standards or Immediate
which they are added but the human body when the food Standards.
is consumed. Over the years, FCC has become a
comprehensive compendium of standards for these articles, Supplements
collectively termed food ingredients. The introduction of The First Supplement to FCC 7 will be published in August
new food ingredients as well as constant changes in 2010 and will become effective 90 days after its publication,
manufacturing processes and advances in analytical and unless otherwise noted. The Index in each Supplement is cu-
metrological sciences lead to a need for continuous revision mulative and includes citations to the biennial revision. The
of the FCC. Because of its regulatory status in countries contents of the Supplement are integrated into the following
other than the United States, and its worldwide use, the FCC edition of FCC, along with new revisions that have been
adopted since the Supplement to the previous compendium.
vi / Preface FCC 7
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nt Expedited Standards consisting of a committee member and other experts or
o Expedited Standards are revisions that the Food Ingredients specialists to address specific issues relevant to
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Expert Committee determines, for public health or other monograph development and to report their findings and
reasons, should become effective prior to publication of the recommendations to the full committee.
next edition of the FCC or Supplement. They become effec- • To evaluate comments submitted by interested parties on
tive on the date posted on the USP website, unless other- any aspect of proposed FCC standards.
wise noted. These revisions will be incorporated into the • To approve final standards before their publication in the
next published edition of the FCC or Supplement. FCC or its supplements.
• To consider and act on any other issues concerning the
Immediate Standards development and publication of standards for new and
Immediate Standards are revisions that the Food Ingredients existing food-grade ingredients.
Expert Committee determines should be made available im- The FIEC meets regularly to discuss food ingredients topics,
mediately because of an urgent public health need. These including technical and policy issues relevant to the FCC.
standards are posted as final on the USP website without
prior public notice and comment and are effective upon Public Participation in FCC Revisions
website publication unless a delayed effective date is speci- Although the FIEC is the ultimate decision-making body for
fied. These standards will be incorporated into the next FCC standards, these standards are developed by an excep-
published edition of the FCC or Supplement. tional process of public involvement and substantial interac-
tion between USP and its stakeholders, both domestically
Errata and internationally. Participation in the revision process re-
Errata are text published in the FCC or its Supplements that sults from the support of many individuals and groups and
do not accurately reflect the intended standards as ap- also from scientific, technical, and trade organizations.
proved by the Food Ingredients Expert Committee. A list of Requests for revision for monographs, either new
errata and corresponding corrections to an edition of the monographs or those needing updating, contain informa-
FCC or to a Supplement are published on USP‘s website, and tion submitted voluntarily by manufacturers and other inter-
incorporated into the next published edition of the FCC or ested parties. At times USP staff may develop information to
Supplement. Errata shall not be subject to public notice and support a monograph through a Request for Revision. USP
comment. has developed a document titled Guideline for Submitting Re-
quests for Revision to FCC, which will be available at
Print and Electronic Presentations www.usp.org.
The FCC and its Supplements are available in print form and To facilitate the continuous revision of FCC and ensure an
in an Internet version that allows individual registered users open, transparent, and participatory revision process, USP
to access the FCC online. The Internet format provides ac- publishes on its website, the FCC Forum (Forum). The Forum
cess to FCC content, along with extensive search options. It is available free of charge and contains several sections. The
is continuously and cumulatively updated to integrate the Introduction section provides information about publication
content of Supplements. For users of the print edition, the and comment deadlines, USP news, and summaries of issues
Supplements are included with the purchase of the FCC. discussed by the Council of Experts and its Expert Commit-
Users of the FCC print edition must retain the Supplements tees. The Proposed Changes and Additions include draft revi-
and review the FCC portion of the USP website in order to sions that are being provided for the purpose of public
have up-to-date information. comment and expected to advance to approval by the FIEC.
Finally, the Stimuli to the Revision Process section of the
FCC REVISION PROCESS Forum presents reports or statements of authoritative bodies,
scientific articles relevant to existing or emerging com-
The FCC is revised on an ongoing basis in accordance with
pendial issues, general commentaries by interested parties,
USP‘s Policies, Rules and Procedures. Users of the FCC are
and summaries of comments received in response to policy
requested and encouraged to submit suggestions for
initiatives. Each issue of the Forum also provides a cumula-
updating and improving the specifications and general
tive index for the given calendar year.
analytical methods, and to review and comment upon
Via the Forum, USP solicits and encourages public com-
proposed revisions, through the processes discussed below.
ment on FCC monographs, General Tests and Assays, and
other draft documents. Thus, the USP standards-setting pro-
Food Ingredients Expert Committee
cess gives those who manufacture, regulate, and use food
The Food Ingredient Expert Committee (FIEC) is part of ingredients the opportunity to comment on the develop-
USP‘s Council of Experts and is the scientific decision- ment and revision of FCC standards. Figure 1 shows the pub-
making body for the FCC. Its principal functions include: lic review and comment process and its relationship to stan-
• To propose means by which FCC standards may be kept dards development.
current in reflecting food-grade quality on the basis of
ingredient safety, good manufacturing practices, and
Working with Government Agencies
advances in analytical capabilities.
• To provide information on issues relating to standards for USP works in many ways with government agencies in the
US and abroad, including the US FDA, to promote good
particular substances and analytical test procedures.
• To recommend the establishment of Advisory Panels communications and optimal interactions. The Government
FCC 7 Preface / vii
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Figure 1. Public Review Process
Liaison Program allows government representatives to par- Codex as defining an ‘appropriate food grade’ within the
ticipate in FIEC meetings, enabling continuing interactions meaning of Sec. 121.101(b)(3) and Sec. 121.1000(a)(2) of
between the regulators‘ scientific staff and Expert Commit- the food additive regulations, subject to the following
tee activities. Staff in the US FDA Centers who are responsi- qualification: this endorsement is not construed to exempt
ble for review of compendial activities provide specific links any food chemical appearing in the Food Chemicals Codex
and opportunities for exchange of comments. The Center from compliance with requirements of Acts of Congress or
for Food Safety and Applied Nutrition is the center that links with regulations and rulings issued by the Food and Drug
FDA and USP in the area of food ingredients. Administration under authority of such Acts.”
Subsequently, various additional specifications from
LEGAL RECOGNITION OF FCC previous FCC editions were also incorporated by reference,
STANDARDS in the U.S. Code of Federal Regulations to define specific safe
ingredients under Title 21, in various parts of Sections 172,
The FCC has earned international recognition by 173, and 184. It is anticipated that FDA will from time to
manufacturers, vendors, and users of food chemicals. FCC time continue to update its regulatory references to the FCC.
standards serve as the basis for many buyer and seller USP will work diligently to assure that the FCC contains
contractual agreements. monographs for all substances added to foods in the U.S.,
In the United States, the first edition was given quasi-legal including all ingredients that are marketed as food additives
recognition in July 1966 by means of a letter of and color additives under an FDA regulation following a
endorsement from FDA Commissioner James L. Goddard, successful petition of FDA, ingredients that are affirmed to
which was reprinted in the book. The letter stated that “the be GRAS, and ingredients that are marketed under
FDA will regard the specifications in the Food Chemicals
viii / Preface FCC 7
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nt approvals issued prior to the 1958 Food Additive the Council of Experts to serve as Expert Committee
o Amendments (prior-sanctioned items). members. Collectively, the Expert Committee chairs and
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In Canada, in the absence of national specifications, the members comprise more than 500 volunteers drawn
Fourth edition of the FCC, as amended from time to time, is from 50 countries. The 41 Standards Expert Committees
officially recognized in the Canadian Food and Drug are responsible for the content of FCC, USP–NF and asso-
Regulations under Section B.01.045(b) as the reference for ciated publications (see Figure 2) and organized in Col-
specifications for food additives. laborative Groups for topics of common interest. The 16
For Australia and New Zealand, the Food Standards Information Expert Committees focus on development of
Australia New Zealand recognizes the Sixth Edition of the Model Guidelines for the Medicare Modernization Act
FCC as a primary source of identity and purity specifications and other information activities. The Council of Experts’
for substances added to food in Standard 1.3.4 Identity and Executive Committee provides overall direction, is an ap-
Purity of its Food Standards Code. peals body, and performs other functions that support
the Council’s operations.
GENERAL INFORMATION REGARDING
Advisory Panels to the Council of Experts
USP
The Chair of the Council of Experts may appoint Advisory
Panels to assist the Council of Experts in reaching scien-
USP GOVERNANCE, STANDARDS-SETTING, AND ADVI- tific decisions and implementing new USP directives relat-
SORY BODIES ing to USP–NF. A listing of Advisory Panels is provided in
USP’s governing, standards-setting, and advisory bodies in- the People section (page xi). This list changes frequently
clude the USP Convention, the Board of Trustees, the Coun- as Advisory Panels conclude, and new ones start their
cil of Experts and its Expert Committees, and Advisory deliberations. There are more than 300 Advisory Panel
Panels. Additional volunteer bodies include Stakeholder members who contribute to the standards–setting activi-
Forums, their Project Teams, and Advisory Groups, which ties of the Council of Experts.
act in an advisory capacity to provide input to USP’s gov-
Stakeholder Forums and Project Teams
erning, standards-setting, and management bodies.
USP has formed several domestic and international Stake-
USP Convention holder Forums and Project Teams in the 2005–2010 cycle
USP’s direction and priorities are determined by more to exchange information and receive comment on USP‘s
than 400 Convention members divided into nine catego- standards-setting activities. Depending on the topic, a
ries (see http://www.usp.org/aboutUSP/governance/con- Stakeholder Forum may form Project Teams to work on
ventionMembers.html). Eligible organizations within each selected topics. USP also holds Annual Scientific Meetings
membership category are invited to appoint a represen- in various regions throughout the world to promote sci-
tative. Convention composition is determined so as to entific exchanges on topics relating to USP compendia.
ensure suitable representation of those sections of the The following are lists of domestic Stakeholder Forums
health care system that are influenced by, and in turn and international Stakeholder Forums and Annual Scien-
influence, USP’s activities. Convention members elect the tific Meetings for the 2005–2010 cycle.
members of USP’s Board of Trustees, including its Presi-
Domestic Stakeholder Forums (US and Canada)
dent and Treasurer, as well as the Council of Experts. • Food Ingredients
They also vote on resolutions to guide USP’s scientific • Prescription/Nonprescription
policy and public health initiatives and update, as • Compounding
needed, USP’s Constitution and By-Laws. The next meet- • Dietary Supplements
ing of the USP Convention is scheduled for April 21–24, • Patient Safety
2010 in Washington, DC.
International Stakeholder Forums and Annual Sci-
Board of Trustees
entific Meetings
USP’s Board of Trustees is entrusted with management of • India/West Asia
the business affairs, finances, and property of USP. Dur- • China/East Asia
ing its five-year term, the Board defines USP’s strategic • Latin America
direction through its key policy and operational decisions. • Europe
A listing of the members of the 2005–2010 Board of • Middle East/North Africa
Trustees appears on the USP website at
http://www.usp.org/aboutUSP/governance/. Staff
USP maintains a staff of over 600 scientists, professionals,
Council of Experts
and administrative personnel at its headquarters in Rock-
The Council of Experts is the standards-setting body of
ville, Maryland and throughout the world. USP labora-
USP. For the 2005–2010 cycle, it is composed of 57 Ex-
tory facilities and account management offices are lo-
pert Committee chairs elected to five-year terms by USP’s
cated in Basel, Switzerland; Hyderabad, India; Sao Paolo,
Convention Members. A Nominating Committee, consist-
Brazil; and Shanghai, China.
ing of the Chair of the Council of Experts, the Conven-
tion President, and the Vice Chair of the Nominating
Committee for the Council of Experts, nominates individ-
uals who are subsequently elected by the members of
FCC 7 Preface / ix
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Figure 2. Organization of the 2005–2010 USP Council of Experts
USP POLICIES, RULES AND PROCEDURES OTHER USP PUBLICATIONS
Governing Documents United States Pharmacopeia and the National For-
USP’s Articles of Incorporation, its Constitution and Bylaws, mulary— The United States Pharmacopeia (USP) and Na-
and the Rules and Procedures of the 2005–2010 Council of tional Formulary (NF) are compendia of science-based stan-
Experts are available on USP’s website (www.usp.org). Col- dards for drug and biologic dosage forms, drug substances,
lectively, these documents serve USP volunteers and staff as excipients, medical devices, and dietary supplements. These
the governing principles for all of USP’s standard–setting standards are set by Expert Committees following public no-
activities. tice and opportunity for comment through publication in
the Pharmacopeial Forum. The USP and NF are recognized
Conflicts of Interest as official compendia of the United States in the Federal
USP’s Conflict of Interest provisions require all members of Food, Drug, and Cosmetic Act, and are recognized in the
the Council of Experts, its Expert Committees and Advisory laws of many countries around the world. The USP and the
Panels, the Board of Trustees, and key staff to disclose signif- NF are separate compendia although they are published in
icant financial interests in companies or other entities that the same volume.
are subject to FCC or USP–NF standards or that may be af-
fected by information in the FCC or USP–NF. Members of USP Dietary Supplements Compendium (DSC)— This
the Board of Trustees, Council of Experts, and related bodies unique reference combines the latest USP–NF standards with
are not allowed to vote on any matter in which they have a information from the FCC; regulatory and industry docu-
conflict of interest or the appearance of a conflict of ments; and helpful tools and resources.
interest. Developed for manufacturers, contract laboratories, and
distributors, the USP DSC contains the Dietary Supplement
Confidentiality and Document Disclosure Health and Education Act (DSHEA) standards and authorita-
Members of the Council of Experts, Expert Committees, and tive information needed to develop, manufacture, and test
Advisory Panels sign confidentiality agreements, in keeping quality dietary supplement products.
with the confidentiality provisions of the Rules and Proce-
dures of the Council of Experts. The USP Document Disclo- Chromatographic Columns— This comprehensive refer-
sure Policy, available on USP’s website, contributes to the ence provides detailed information needed to conduct chro-
transparency of the standards-setting process by making in- matographic procedures found in USP–NF. Chromatographic
formation available to the public, yet provides protection to Columns lists the brand names of the column reagents cited
manufacturers and others who submit confidential informa- in every proposal for new or revised gas– or liquid–chro-
tion to USP. matographic analytical procedures that have been published
in PF since 1980. Chromatographic Columns also helps to
track which column reagents were used to validate analyti-
cal procedures that have become official.
x / Preface FCC 7
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nt USP Pharmacists’ Pharmacopeia— USP–NF is directed names of distributors who can facilitate international availa-
o primarily to pharmaceutical and dietary supplement manu- bility of these items are suggested. The USP Reference Stan-
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facturers, although it contains many monographs and allied dards program benefits from the widespread voluntary con-
text useful for the compounding practitioners. To better ac- tribution of suitable materials and test data from
commodate the needs of these practitioners and more gen- manufacturers. USP advances this unofficial material to offi-
erally the needs of the pharmacy community, USP has made cial status via careful characterization studies and collabora-
available the USP Pharmacists’ Pharmacopeia. This text pro- tive testing, followed by review and, if appropriate, approval
vides pharmacy-relevant abridged official text from the by the Reference Standards Committee of the Council of
USP–NF as well as authorized information. The former refers Experts.
to standards for official articles, while the latter is more gen-
eral information designed to be useful to practitioners. Both IN MEMORIAM
types of text are developed under the Rules and Procedures
USP gratefully acknowledges the valuable scientific
of the Council of Experts. The USP Pharmacists’
contributions of Durward F. Dodgen and Paul Kuznesof, Ph.D.
Pharmacopeia is available in print version.
in the compilation of the Food Chemicals Codex.
Durward Dodgen was a food additives scientist and early
USP Dictionary— The USP Dictionary of USAN and Inter-
contributor to the Food Chemicals Codex during his tenure as
national Drug Names provides in a single volume the most
a senior staff officer at the National Academy of Sciences.
up-to-date United States Adopted Names of drugs; official
Mr. Dodgen also worked at the US Food and Drug
USP–NF names; nonproprietary, brand, and chemical names;
Administration (FDA) where he provided scientific expertise
graphic formulas; molecular formulas and weights; CAS reg-
on the first formulation of the Codex General Standard for
istry numbers and code designations; drug manufacturers;
Food Additives. He made major contributions to currently
and pharmacologic and therapeutic categories. The Diction-
used concepts pivotal for analysis of the safety of food and
ary helps to ensure the accuracy of the following: product
food additives. Mr. Dodgen was a pioneer in the collection
labeling; reports, articles, and correspondence; FDA regula-
and formulation of scientific data still in use today for the
tory filings; and pharmaceutical package inserts. It is pub-
evaluation of exposure to food and food additives.
lished annually (latest edition April 2009) and is recognized
Dr. Paul M. Kuznesof was a former Senior Review Chemist
by FDA as the official source for established drug names.
with FDA with vast experience in evaluating chemistry-
USP Catalog— Use of official USP Reference Standards related information in relation to food safety. Dr Kuznesof’s
promotes uniform quality of drugs and supports first-, sec- work at FDA involved exposure assessments of food and
ond-, and third-party testing of all manufactured and com- color additives, GRAS ingredient petitions and GRAS
pounded articles. The publication listing the collection of notifications. Dr. Kuznesof also achieved world renown as
official USP Reference Standards can be accessed on the USP an expert in international risk/safety assessment resulting
website at www.usp.org and is available in print form by from his membership on the Joint FAO/WHO Expert
contacting USP Sales and Marketing staff at 301-816-8237. Committee on Food Additives (JECFA). More recently, Dr.
The listing identifies new items, replacement lots, lots of a Kuznesof was a consultant to USP and provided invaluable
single item that are simultaneously official, lots deleted from assistance and oversight in the publication of the Food
official status, and a preview of items eventually to be Chemicals Codex Sixth Edition.
adopted. Purchase order information is included, and the
FCC 7 Contents / iii
Contents
PREFACE.............................................................................................................................................................. v
PEOPLE............................................................................................................................................................... xi
ADMISSIONS.................................................................................................................................................... xix
ANNOTATED...................................................................................................................................................... xx
GENERAL PROVISIONS AND REQUIREMENTS APPLYING TO SPECIFICATIONS,
TESTS, AND ASSAYS OF THE FOOD CHEMICALS CODEX.............................................................................. 1
MONOGRAPH SPECIFICATIONS........................................................................................................................ 9
GENERAL TESTS AND ASSAYS.................................................................................................................... 1103
Appendix I: Apparatus for Test and Assays................................................................................................. 1107
Appendix II: Physical Tests and Determinations.......................................................................................... 1111
A. Chromatograhy............................................................................................................................... 1111
B. Physicochemical Properties............................................................................................................. 1120
C. Others............................................................................................................................................ 1132
Appendix III: Chemical Tests and Determinations...................................................................................... 1144
A. Identification Tests.......................................................................................................................... 1144
B. Limit Tests....................................................................................................................................... 1146
C. Others............................................................................................................................................ 1161
Appendix IV: Chewing Gum Base.............................................................................................................. 1178
Appendix V: Enzyme Assays....................................................................................................................... 1182
Appendix VI: Essential Oils and Flavors...................................................................................................... 1215
Appendix VII: Fats and Related Substances................................................................................................ 1220
Appendix VIII: Oleoresins........................................................................................................................... 1232
Appendix IX: Rosins and Related Substances.............................................................................................. 1235
Appendix X: Carbohydrates (Starches, Sugars, and Related Substances..................................................... 1239
Appendix XI: Flavor Chemicals (Other Than Essential Oils)........................................................................ 1250
SOLUTIONS AND INDICATORS................................................................................................................... 1256
GENERAL INFORMATION............................................................................................................................ 1271
INDEX............................................................................................................................................................ 1385
FCC 7 General Provisions and Requirements / 1
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General Provisions and Requirements Applying to t M
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Specifications, Tests, and Assays of the r
Food Chemicals Codex
The General Provisions provide, in summary form, guidelines • Guidance for establishing and using Good Manufacturing
for the interpretation and application of the standards, tests Practices
and assays, and other specifications of the Food Chemicals • Validated testing methods (including enzyme assays and
Codex and make it unnecessary to repeat throughout the methods that use highly-characterized reference
book those requirements that are pertinent in numerous in- standards)
stances. Where exceptions to the General Provisions are • Minimum standards for identity, purity, and quality of
made, the wording in the individual monograph or general food ingredients
test chapter takes precedence and specifically indicates the Food ingredient manufacturers, processors, and
directions or the intent. purchasers often use the FCC’s standards as the basis for
establishing minimum requirements for identity, purity, and
TITLE OF BOOK quality of their ingredients. FCC standards are also used to
define these parameters within commercial purchase
The title of this book, including its supplements, is the Food
agreements between buyers and sellers of ingredients and
Chemicals Codex, Seventh Edition. It may be abbreviated to
food and, thus, help to promote food quality and food
FCC 7. Where the term FCC is used without further
safety programs in industry. The validated test methods
qualification in the text of this book, it applies to the Food
included in the FCC can be used to demonstrate the
Chemicals Codex, Seventh Edition.
identity, quality, and purity of food ingredients, or they can
be a starting point in developing new test methods.
APPROPRIATE USE OF THE FOOD
Manufacturers, processors, and purchasers of food
CHEMICALS CODEX ingredients will find these validated test methods useful, as
As a compendium that addresses known food ingredients will regulatory agency labs, contract labs, and students of
used in food products either in the United States or chemistry or food science. In addition to being a resource
internationally, the FCC has many practical applications in for purchasing and quality control operations, portions of
industry, research, and academia. The FCC does not, the FCC are useful to quality assurance groups and can serve
however, provide information on the regulatory status or as references for internal Standard Operating Procedures
safety of food chemicals, nor does the presence or absence (SOPs) and quality manuals used by the food industry. The
of standards for a particular food ingredient indicate in any FCC is an excellent resource that may be used to provide
way USP’s endorsement (or lack thereof) of that item for use important information in order to ascertain identity, quality,
in foods or food processing. It is the responsibility of the and purity of ingredients. In addition, the FCC can be an
user to determine the safety and regulatory status of a important part of a food manufacturer or purchaser’s
particular food ingredient for any specific application. comprehensive food quality program and it provides a
FCC standards have been developed in cooperation with common basis for evaluations of food ingredients in all
regulatory authorities and industry in the United States both aspects of food research and the food industry.
under the stewardship of the Institute of Medicine and,
more recently, USP. While USP makes great efforts to FCC SPECIFICATIONS
dialog with the United States Food and Drug Administration FCC specifications are presented in monograph form for
(FDA) regarding creating or revising monograph standards each substance or group of related substances. They are
in the FCC, USP has no official legislative authority to designed to ensure that food ingredients have the specified
establish legal requirements for food ingredients in the identity and a sufficiently high level of quality to be safe
United States. 1The FCC serves as guidance for companies under usual conditions of intentional use in foods or in food
that manufacture, process, purchase, or use food ingredients processing. Thus, FCC specifications generally represent
and seek to determine appropriate minimum standards for acceptable levels of quality and purity of food-grade
components of their food products. ingredients available in the United States (or in other
The structure and format of the FCC monographs and countries or instances in which FCC specifications are
informational chapters allow users to quickly access the recognized).
following types of information: Manufacturers, vendors, and users of FCC substances are
• General information about food ingredients expected to exercise good manufacturing practices (GMPs)
• Chemical information specific to food ingredients (see General Information). They are also expected to
• Information regarding laboratory method validation establish food safety assurance systems such as Hazard
components Analysis and Critical Control Points (HACCP) to ensure that
FCC substances are safe and otherwise suitable for their
1For further information about the legal status of FCC, see Legal Recognition of
FCC Standards, Preface. intended use. FCC substances must meet applicable
2 / General Provisions and Requirements FCC 7
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nt regulatory requirements, including microbiological criteria, Molecular Structures and Chemical Formulas Molecular
o for safety and quality. structures, chemical formulas, and formula weights immedi-
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The name of the substance on a container label, plus the ately following titles are included for the purpose of infor-
designation “Food Chemicals Codex Grade,” “FCC Grade,” or mation and are not to be considered an indication of the
simply “FCC,” is a representation by the manufacturer, purity of the substance. Molecular formulas given in specifi-
vendor, or user of the substance that at the time of cations, tests, and assays, however, denote the pure chemi-
shipment, it conforms to the specifications in FCC 7, cal entity.
including any Supplement that is current at that time. When CAS Number If available, Chemical Abstracts Service (CAS)
an FCC substance is available commercially in solution form registry numbers are included for informational purposes.
as a component of a mixture and there is no provision in Additional CAS numbers may be relevant.
the FCC for such solution or mixture, the manufacturer, INS Numbers If available, numbers adopted by the Codex
vendor, or user may indicate on the label that the product Alimentarius Commission under the International Number-
contains substances meeting FCC specifications by use of the ing System for Food Additives are included for informational
initials “FCC” after the name of those components that meet purposes.
the FCC requirements. For the labeling of FCC substances in FEMA Numbers If available, numbers assigned by the Fla-
which added substances are permitted, see Added vor and Extract Manufacturers Association of the United
Substances. States (FEMA) are included for informational purposes.
Added Substances FCC specifications are intended for Alternative Analytical Procedures Although the tests
application to individual substances and not to proprietary and assays described constitute procedures upon which the
blends or other mixtures. Some specifications, however, al- specifications of the FCC depend, analysts are not prevented
low “added substances” (i.e., functional secondary ingredi- from applying alternative procedures if supporting data
ents such as anti-caking agents, antioxidants, diluents, emul- shows that the procedures used will produce results of equal
sifiers, and preservatives) intentionally added when or greater accuracy. In the event of the doubt or disagree-
necessary to ensure the integrity, stability, utility, or func- ment concerning a substance purported to comply with the
tionality of the primary substance in commercial use. requirements of the FCC, only the methods described herein
If an FCC monograph allows such additions, each added are applicable and authoritative.
substance must meet the following requirements: (1) it is
approved for use in foods by the U.S. Food and Drug Ad- Labeling For purpose of compliance with FCC
ministration or by the responsible government agency in monographs, “labeling” means all labels and other written,
other countries in which the FCC specifications are recog- printed, or graphic matter (1) on any article of any of its
nized; (2) it is of appropriate food-grade quality and meets containers or wrappers or (2) accompanying such article, or
the requirements of the FCC, if listed therein; (3) it is used in otherwise provided by vendors to purchasers for purposes of
an amount not to exceed the minimum required to impart product identification.
its intended technical effect or function in the primary sub- Sulfiting agents If an FCC substance contains 10 mg/kg or
stance; (4) its use will not result in concentrations of con- more of any sulfiting agent, the presence of such sulfiting
taminants exceeding permitted levels in any food as a con- agent shall be indicated on the labeling.
sequence of the affected FCC primary substance‘s being
used in food; and (5) it does not interfere with the tests and Requirements for Listing Substances in
assays prescribed for determining compliance with the FCC the FCC
requirements for the primary substance, unless the mono-
The requirements for listing substances in the FCC are as
graph for the primary substance has provided for such inter-
follows: (1) the substance is permitted for use in food or in
ferences. Where added substances are specifically permitted
food processing in the United States (or, in certain cases, in
in an FCC substance, the label shall state the name(s) and
other countries in which FCC specifications are recognized),
amount(s) of any added substance(s).
(2) it is commercially available, and (3) suitable
Adding substances not specifically provided for and men-
specifications and analytical test procedures are available to
tioned by name or function in the monograph of an FCC
determine its identity and purity.
substance will cause the substance to no longer be desig-
nated as an FCC substance. Such a combination is a mix-
GENERAL SPECIFICATIONS AND
ture to be described by disclosure of its ingredients, includ-
ing any that are not FCC substances. STATEMENTS
Certain specifications and statements in the monographs of
Title of Monograph The titles of FCC monographs are in
the FCC are not amenable to precise description and
most instances the common or usual names. FCC specific-
accurate determination within narrow limiting ranges.
ations apply equally to substances bearing the main titles,
Because of the subjective or general nature of these
synonyms listed under the main titles, and names derived
specifications, good judgment, based on experience, must
by transposition of definitive words in main titles. The no-
be used in interpreting and attaching significance to them.
menclature used for flavoring agents may not be consistent
with other authoritative sources.
Description Characteristics described and statements
made in the Description section of a monograph are not