Sei sulla pagina 1di 6

FCC 10 Preface / v

Front Matter
Preface
FCC 10 of the FCC. Because of its regulatory status in countries
This section provides general information about the Tenth other than the United States, and its worldwide use, the FCC
Edition of the Food Chemicals Codex (FCC) and background contains monographs for ingredients that may not be
information on the United States Pharmacopeial Convention currently marketed in the United States.
(USP). Additional information about the specific uses of this USP acquired FCC from the NAS in 2006 and assumed
compendium is provided in the General Provisions and responsibility for its ongoing development and publication.
Requirements section (page 1). To continue the work of the Food and Nutrition Board of
IOM, USP formed a Food Ingredients Expert Committee
within its Council of Experts. This Expert Committee is
MISSION STATEMENT responsible for approving all new and revised standards in
FCC is published in continuing pursuit of the mission of USP: FCC.
To improve global health through public standards and related
programs that help ensure the quality, safety, and benefit of FCC 10
medicines and foods.
The Tenth Edition of FCC (FCC 10) includes more than
1,200 ingredient-specific standards, including monographs
HISTORY and FCC identity standards. It also contains more than 150
FCC began after the passage of the 1958 Food Additives General Tests and Assays, providing procedures frequently
Amendment to the United States (U.S.) Federal Food, Drug, cited in ingredient-specific standards, sometimes with
and Cosmetic Act. Although the U.S. Food and Drug acceptance criteria, in order to avoid repetition of this text.
Administration (FDA) had, by regulations and informal Additionally, FCC 10 includes a General Information section
statements, defined in general terms the quality with up-to-date relevant informational materials on method
requirements for food additives, food colors, substances validation and various analytical techniques, reference
generally recognized as safe for use in foods (GRAS) and tables, information on current Good Manufacturing
other food chemicals in the U.S. market prior to 1958 Practices. Additions, omissions, and other revisions of text
(prior-sanctioned articles), these requirements were not from the FCC Ninth Edition are indicated on page xv in the
sufficiently specific to serve as release, procurement, and Admissions section. The FCC and its Supplements become
acceptance specifications for manufacturers and users of effective 90 days from the date of publication, unless
food chemicals. Therefore, regulators, industry, and other otherwise noted.
interested parties recognized the need for a compendium of
standards designed especially for food chemicals, Monograph Elements
comparable to the United States Pharmacopeia for drugs and Each FCC monograph and FCC identity standard represents
the National Formulary for excipients, which would define the documentary standard for an article, manifested by
the quality of food-grade chemicals in terms of identity, specifications that speak to the quality and safety of the
strength, and purity. The National Academy of Sciences food ingredient. Each monograph and FCC identity standard
(NAS) was requested to develop this compendium and includes, when available, the following: empirical formula,
published the first edition of the FCC in 1966. Subsequent structural formula, and formula weight; description of the
editions were published by the NAS in 1972, 1981, 1996, substance, including physical form, odor (flavoring agents
and 2003, through the Food and Nutrition Board of the only), and solubility (see the descriptive terms for solubility
Institute of Medicine (IOM), which formed a Committee on in the General Provisions and Requirements section); function;
Food Chemicals Codex to elaborate the FCC. packaging and storage; labeling; identification; assay (or a
The scope of FCC has expanded with each new edition. quantitative test to serve as an assay); impurities (inorganic
Substances included in the first edition were limited to and organic); specific tests; and other requirements. The
chemicals added directly to foods to achieve a desired specifications provided, taken together, represent a compo-
function. Subsequent editions added: (a) processing aids sitional understanding of the ingredient.
such as enzymes, extraction solvents, filter media, and boiler
water additives; (b) foods, such as fructose and dextrose; PUBLICATION OF FCC REVISIONS
and (c) functional ingredients that affect not the foods to
FCC revisions are published biennially in new editions, in
which they are added, but the human body when the food
Supplements published every six months in intervening years
is consumed. Over the years, FCC has become a
and, when circumstances warrant, as Expedited Standards or
comprehensive compendium of standards for these articles,
Immediate Standards.
collectively termed food ingredients. The introduction of
new food ingredients as well as constant changes in
Supplements
manufacturing processes and advances in analytical and
The First Supplement to FCC 10 will be published in Septem-
metrological sciences lead to a need for continuous revision
ber 2016 and will become effective 90 days from the date
vi / Preface FCC 10
Front Matter

of publication, unless otherwise noted. The Index in each Revision Type Symbol Subscript
Supplement is cumulative and includes citations to the bien- Text Deletion Adopted as Effective Date
nial revision. The contents of the Supplement are integrated an Expedited or Immedi- ••
ate Standard
into the next published edition of FCC, along with new revi-
sions that have been adopted since the Supplement to the Text Deletion Adopted in ■
1S, 2S, 3S (FCC biennial

a Supplement edition)
previous compendium.
Text Deletion Adopted in ▲
FCC biennial edition

Expedited Standards FCC
Expedited Standards are revisions that the Food Ingredients New Text Adopted as an Effective Date
Expert Committee determines, for public health or other Expedited or Immediate •new text•
Standard
reasons, should become effective prior to publication of the
next published edition of the FCC or Supplement. Proposed New Text Adopted in a 1S, 2S, 3S (FCC biennial
■ new text■
Supplement edition)
expedited standards are posted on the FCC Forum website
for a comment period of 90 days. If there are no significant New Text Adopted in FCC ▲ new text▲ FCC biennial edition
comments, they are posted on the USP website with the Errata •new text• Effective Date
effective date indicated. These revisions will be incorporated
into the next published edition of the FCC or Supplement. The following table shows symbols and effective dates for
FCC 10 and its Supplements:
Immediate Standards
Immediate Standards are revisions that the Food Ingredients Supplement Effective Date Symbols
Expert Committee determines should be made available im- FCC 10 June 1, 2016 ▲ and▲ FCC10
mediately because of an urgent public health need. These 1 December 1, 2016 ■and■1S (FCC10)
standards are posted as final on the USP website without 2 June 1, 2017 ■and■2S (FCC10)
prior public notice and comment with the effective date in-
3 December 1, 2017 ■and■3S (FCC10)
dicated. These standards will be incorporated into the next
published edition of the FCC or Supplement.

Errata FCC REVISION PROCESS


Errata are text published in the FCC or its Supplements that The FCC is revised on an ongoing basis in accordance with
do not accurately reflect the intended standards as ap- USP policies and the Rules and Procedures of the
proved by the Food Ingredients Expert Committee. A list of 2015–2020 Council of Experts. Users of the FCC are
Errata and corresponding corrections to an edition of the requested and encouraged to submit suggestions for
FCC or to a Supplement are published on USP’s website, and updating and improving the specifications and general
become effective on the first day of the month following analytical methods, and to review and comment upon
their posting. Errata are incorporated into the next pub- proposed revisions through the processes described below.
lished edition of the FCC or Supplement. Errata shall not be
subject to public notice and comment. Food Ingredients Expert Committee
Learn more about Errata here: http://www.usp.org/food-
The Food Ingredients Expert Committee (FIEC) is part of
ingredients/development-process/revisions-commentary-
USP’s Council of Experts and is the scientific decision-
errata.
making body for the FCC. Its principal functions include the
following:
Print and Electronic Presentations
• To propose means by which FCC standards may be kept
The FCC and its Supplements are available in print form and
current in reflecting food-grade quality on the basis of
in an Internet version that allows individual registered users
ingredient safety, good manufacturing practices, and
to access the FCC online. The Internet format provides ac-
advances in analytical capabilities.
cess to FCC content, along with extensive search options. It
• To provide information on issues relating to standards for
is continuously and cumulatively updated to integrate the
particular food ingredients and analytical test procedures.
content of Supplements. For users of the print edition, the
• To recommend the establishment of Expert Panels
Supplements are included with the purchase of the FCC.
consisting of a Committee member and other experts or
Users of the FCC print edition must retain the Supplements
specialists to address specific issues relevant to the
and review the FCC portion of the USP website in order to
development of FCC standards and to report their findings
have up-to-date information.
and advisory recommendations to the full committee.
Symbols • To evaluate comments submitted by interested parties on
Indicating change to effective text, symbols identify the be- any aspect of proposed FCC standards.
ginning and end of each revision. The following table sum- • To approve final standards before their publication in the
marizes the types of symbols and the associated subscripts FCC or its Supplements.
used in FCC publications: • To consider and act on any other issues concerning the
development and publication of standards for new and
existing food-grade ingredients.
The FIEC meets regularly to discuss food ingredients topics,
including technical and policy issues relevant to the FCC.
FCC 10 Preface / vii

Front Matter
Figure 1. Public Review Process

FDA government liaisons also participate in the FIEC’s proposed standards based on those comments. Proposed
standards-setting activities. Learn more about the work of standards are finalized when the FIEC votes to make them
the FIEC here: http://www.usp.org/food-ingredients/ effective text in FCC. Thus, the USP standards-setting pro-
development-process/revision-leadership. cess gives those who manufacture, regulate, and use food
ingredients the opportunity to comment on the develop-
Public Participation in FCC Revisions ment and revision of FCC standards. All published proposed
Although the FIEC is the ultimate decision-making body for revisions to standards will have a 90-day comment period
FCC standards, these standards are developed by an excep- unless otherwise indicated. Figure 1 shows the public review
tional process of public involvement and substantial interac- and comment process and its relationship to the FCC revi-
tion between USP and its stakeholders, both domestically sion process.
and internationally. Participation in the revision process re-
sults from the support of many individuals and groups and
Commentary
also from scientific, technical, and trade organizations.
In accordance with the Rules and Procedures of the
Requests for revision of monographs or FCC identity stan-
2015–2020 Council of Experts, revision proposals can ad-
dards, either new or those needing updating, contain infor-
vance to effective status with modifications made by the
mation submitted voluntarily by manufacturers and other in-
FIEC in response to the public comments that are received,
terested parties. To facilitate this, USP has developed a
without requiring further public review and comment. In
document titled Guideline for Submitting Requests for Revision
such cases a summary of all comments received and the
to FCC, which is available at http://www.usp.org/food-ingre-
FIEC’s responses are published in the Commentary section of
dients/development-process/submit-monographs-revisions.
the FCC website http://www.usp.org/food-ingredients/devel-
At times, USP staff may develop information to support a
opment-process/revisions-commentary-errata when the revi-
revision.
sion becomes publicly available. For those proposals that re-
To facilitate the continuous revision of FCC and ensure an
quire further revision and republication in FCC Forum, a
open, transparent, and participatory revision process, USP
summary of the comments and the Expert Committee’s re-
solicits and encourages public comment on FCC mono-
sponses will be included in the briefing that accompanies
graphs or FCC identity standards, General Tests and Assays,
each revised monograph, FCC identity standard, or General
and other draft documents via the FCC Forum. The Forum is
Tests and Assays. The Commentary is not part of the text of
available free of charge. For more information on the FCC
the monograph, FCC identity standard, or of General Tests
Forum, visit www.usp.org/food-ingredients.
and Assays. Rather, it explains the basis of the FIEC’s re-
Public comments received in response to proposed FCC
sponse to public comments. If there is a difference between
standards are reviewed and considered by the FIEC. The
the contents of the Commentary and the monograph, FCC
FIEC determines whether revisions should be made to the
identity standard, or General Tests and Assays, the text of
viii / Preface FCC 10
Front Matter

the monograph, FCC identity standard, or General Tests and GENERAL INFORMATION REGARDING
Assays prevails. USP
LEGAL RECOGNITION OF FCC USP GOVERNING, STANDARDS-SETTING, AND ADVI-
STANDARDS SORY BODIES
The FCC has earned international recognition by USP’s governing, standards-setting, and advisory bodies in-
manufacturers, vendors, and users of food chemicals. FCC clude the USP Convention, the Board of Trustees, the Coun-
standards serve as the basis for many buyer and seller cil of Experts and its Expert Committees, Joint Standard Set-
contractual agreements between buyers and sellers of food ting Subcommittees, Expert Panels, and staff. Additional
ingredients. volunteer bodies include Stakeholder Forums and Project
In the United States, the first edition of the FCC was given Teams, which offer stakeholders the opportunity to contrib-
quasi-legal recognition in July 1966 by means of a letter of ute, through advice and recommendations, to the advance-
endorsement from FDA Commissioner James L. Goddard, ment of USP’s standards and processes. Learn about the
which was reprinted in the book. The letter stated that “the composition and work of the USP Convention, Board of
FDA will regard the specifications in the Food Chemicals Trustees, Expert Committees, Joint Standard Setting Sub-
Codex as defining an ‘appropriate food grade’ within the committees and Expert Panels on the USP website (http://
meaning of Sec. 121.101(b)(3) and Sec. 121.1000(a)(2) of www.usp.org/about-usp/leadership/governance). Learn
the food additive regulations, subject to the following more about Stakeholder Forums and Project Teams on the
qualification: this endorsement is not construed to exempt USP website (http://www.usp.org/meetings-courses/stake-
any food chemical appearing in the Food Chemicals Codex holder-forums). A listing of all current Voting Delegates of
from compliance with requirements of Acts of Congress or the USP Convention and members and Government Liaisons
with regulations and rulings issued by the Food and Drug to the Council of Experts and its Expert Committees and
Administration under authority of such Acts.” Expert Panels is included in the People section of the FCC.
Subsequently, various additional specifications from
previous FCC editions were also incorporated by reference in Working with the Food and Drug Administration
the U.S. Code of Federal Regulations to define specific food and Other Government Agencies
ingredients under Title 21, in various parts of Sections 172, USP works with the Secretary of the Department of Health
173, and 184. It is anticipated that FDA will from time to and Human Services, and the principal agency in the De-
time continue to update its regulatory references to the FCC. partment for this work is the Food and Drug Administration
In Canada, under Section B.01.045(b) of the Canadian (FDA). USP works in many ways with the agency, but the
Food and Drug Regulations, in the absence of national primary interaction is through the Government Liaison Pro-
specifications, a food additive must meet the specifications gram. The Government Liaison Program allows representa-
of the Fourth Edition of the FCC, as amended from time to tives of FDA and other government agencies to participate
time, when the FCC sets out specifications for the additive. in Expert Committee and Expert Panel meetings, enabling
In the Australia and New Zealand Food Standards Code interactions between government staff and Expert Commit-
Standard 1.3.4 Identity and Purity, a food additive must tees. Staff in the FDA Centers who are responsible for review
comply with a relevant monograph published in: (1) a of compendial activities provide specific contacts and oppor-
Schedule to the Food Standards Code; or (2) the Joint FAO/ tunities for exchange of information and comments. The
WHO Expert Committee on Food Additives (JECFA) Center for Food Safety and Applied Nutrition is the center
Combined Compendium of Food Additive Specifications; or (3) that links FDA and USP in the areas of food ingredients and
the Ninth Edition of the FCC. FCC. USP has no role in enforcement of FCC standards,
In Israel, the Public Health Regulations on food additives which is the responsibility of the FDA and other government
state that those who produce, import, market, or store a authorities in the United States and elsewhere.
food additive must comply with the requirements
established in the latest edition of the FCC or in the latest USP POLICIES, RULES, AND PROCEDURES
edition of the JECFA Compendium of Food Additive
Specifications. Governing Documents
Argentina, Brazil, Uruguay, and Paraguay have adopted as FCC standards are recognized widely because they are au-
their national law MERCOSUR/GMC/RES N° 31/92, which thoritative and science-based and are established by a trans-
requires authorized food additives to comply with purity parent and credible process. USP’s Articles of Incorporation,
requirements established by FAO/WHO or the FCC. its Constitution and Bylaws, and the Rules and Procedures of
Learn more about legal recognition of the FCC in the the 2015–2020 Council of Experts are available on USP’s
United States and legal recognition of the FCC website (http://www.usp.org/about-usp/leadership). Collec-
internationally here: http://www.usp.org/about-usp/legal- tively, these documents serve USP volunteers and staff as
recognition/usp-us-law. the governing principles for USP’s standards-setting
activities.
FCC 10 Preface / ix

Front Matter
Conflicts of Interest USP on Compounding: A Guide for the Compound-
USP’s Conflict of Interest provisions require all members of ing Practitioner— USP on Compounding is an electronic
the Council of Experts, its Expert Committees, Joint Stan- compendium that includes all compounding-related general
dard Setting Subcommittees, Expert Panels, Board of Trust- chapters from the USP–NF as well as the supporting general
ees, and key staff to disclose financial or other interests that chapters that are referenced in the compounding general
may interfere with their duties as USP volunteers. Members chapters and in USP–NF General Notices and Requirements.
of the Board of Trustees, Council of Experts, and its Expert The purpose of USP on Compounding is to provide com-
Committees are not allowed to take part in the final discus- pounding practitioners with convenient access to associated
sion or vote on any matter in which they have a conflict of general chapters.
interest or there is the appearance of a conflict of interest.
Members of Expert Panels provide advisory input only and USP Herbal Medicines Compendium— The USP Herbal
may discuss and vote on matters reflecting the views of Medicines Compendium (HMC) is an online compendium that
outside interests, so long as all such interests and any con- will help ensure the quality of the herbal ingredients used in
flicts have been adequately and promptly disclosed and are herbal medicines. HMC monographs provide quality specifi-
communicated to the relevant Expert Committee along with cations—tests, procedures, and acceptance criteria—with
any Expert Panel recommendations. validated analytical procedures and allied reference materials
that aid in conformity assessment. HMC can help ingredient
Confidentiality and Document Disclosure manufacturers, herbal product manufacturers, regulatory
Members of the Council of Experts, Expert Committees, agencies, and other stakeholders to assess conformance of
Joint Standard Setting Subcommittees, and Expert Panels herbal medicinal ingredients with independent public stan-
sign confidentiality agreements, in keeping with USP’s Con- dards and control the quality of articles moving in interna-
fidentiality Policy and the confidentiality provisions of the tional commerce. The HMC is available at hmc.usp.org.
Rules and Procedures of the Council of Experts, except where
it is agreed upon formation of an Expert Panel that the OTHER USP RESOURCES
Panel will not receive confidential information and will work
solely in a non-confidential manner. The USP Document Dis- Chromatographic Columns— This comprehensive refer-
closure Policy, available on USP’s website, contributes to the ence, previously titled Chromatographic Reagents, provides
transparency of the standards-setting process by making in- detailed information needed to conduct chromatographic
formation available to the public, yet provides protection to procedures found in USP–NF. Chromatographic Columns lists
manufacturers and others who submit confidential informa- the brand names of the column reagents cited in every pro-
tion to USP. posal for new or revised gas- or liquid-chromatographic ana-
lytical procedures that have been published in PF since
OTHER USP PUBLICATIONS 1980. Chromatographic Columns also helps to track which
column reagents were used to validate analytical procedures
United States Pharmacopeia and the National For- that have become official. The branded column reagents list
mulary— The United States Pharmacopeia (USP) and Na- is updated bimonthly and maintained on USP’s website.
tional Formulary (NF) are compendia of science-based stan-
dards for drug and biologic dosage forms, drug substances, USP Dictionary— The USP Dictionary of USAN and Inter-
excipients, medical devices, and dietary supplements. The national Drug Names provides, in a single volume, the most
USP and the NF are separate compendia although they are up-to-date United States Adopted Names of drugs; official
published in the same set of volumes. These standards are USP–NF names; nonproprietary, brand, and chemical names;
set by Expert Committees following public notice and op- graphic formulas; molecular formulas and weights; CAS reg-
portunity for comment through publication in the free Phar- istry numbers and code designations; drug manufacturers;
macopeial Forum. The USP and NF have long had a role in and pharmacologic and therapeutic categories. The Diction-
the adulteration and misbranding provisions of the Federal ary helps to ensure the accuracy of the following: product
Food, Drug, and Cosmetic Act, which defines the term “offi- labeling; reports, articles, and correspondence; FDA regula-
cial compendium” as the official USP, the official NF, or any tory filings; and pharmaceutical package inserts. It is pub-
supplement to them. USP and NF also play varying roles lished annually.
outside the U.S.—as with FCC the standards may be freely
adopted or adapted. And also as with FCC, USP has no role USP Catalog— Use of official USP Reference Standards
in enforcement of USP–NF standards. promotes uniform quality of drugs, food ingredients, and
dietary supplements and supports first-, second-, and
USP Dietary Supplements Compendium— The Dietary third-party testing of all manufactured and compounded ar-
Supplements Compendium is a two-volume set that combines ticles. The publication listing the collection of official USP
USP–NF standards for dietary supplements, standards and in- Reference Standards can be accessed on the USP website at
formation from the Food Chemicals Codex, regulatory and www.usp.org and is available in print form by contacting
industry documents, and other tools and resources. It is USP Sales and Marketing staff via telephone at 301-816-
published every three years as a hardcover print edition. 8237. The listing identifies new items, replacement lots, lots
of a single item that are simultaneously official, and lots
deleted from official status. Purchase order information is
included, and the names of distributors who can facilitate
x / Preface FCC 10
Front Matter

international availability of these items are suggested. The needed, collaborative testing, followed by review and ap-
USP Reference Standards program benefits from the wide- proval by the appropriate Expert Committee or Joint Stan-
spread voluntary contribution of suitable materials and test dard Setting Subcommittee of their use in a compendial
data from manufacturers. USP advances Reference Standard method.
development via careful characterization studies and if

Potrebbero piacerti anche