Combined Compendium of Food Additive Specification

334 Pages·2006·2.05 MB·English

by  Joint FAO WHO Expert Committee on Food Additives

ISSN 1817-7077
1
F A O J E C F A M o n o g r a p h s
COMBINED COMPENDIUM
OF FOOD ADDITIVE
SPECIFICATIONS
Joint FAO/WHO Expert Committee on Food Additives
All specifications monographs from the
1st to the 65th meeting (1956–2005)
4
Volume
Analytical methods, test procedures and
laboratory solutions used by and referenced
in the food additive specifications
ISSN 1817-7077
1
F A O J E C F A M o n o g r a p h s
COMBINED COMPENDIUM
OF FOOD ADDITIVE
SPECIFICATIONS
Joint FAO/WHO Expert Committee on Food Additives
All specifications monographs
from the 1st to the 65th meeting (1956–2005)
4 1
Volume Volume
Analytical methods, test procedures and
laboratory solutions used by and referenced
in the food additive specifications
FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS
Rome, 2006
The designations employed and the presentation of the material in this information
product do not imply the expression of any opinion whatsoever on the part of the Food
and Agriculture Organization of the United Nations concerning the legal or development
status of any country, territory, city or area or of its authorities, or concerning the
delimitation of its frontiers or boundaries.
ISBN 92-5-105569-6
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© FAO 2006
iii
ACKNOWLEDGEMENTS

FAO Food and Nutrition Paper 52, “Compendium of Food Additive Specifications” (FNP 52)
was first published in 1992. It combined all of the food additive specifications prepared by
JECFA from its first meeting in 1956 to its thirty-seventh meeting in 1990. A companion
publication, FAO Food and Nutrition Paper 5, “Guide to Specifications” (FNP 5) contained
the analytical methods, test procedures and laboratory solutions used in and referenced by
JECFA food additive specifications. It was first published in 1978 and revised in 1991.

The decision was made to prepare an updated second edition of FNP 52 to include all food
additive specifications prepared by JECFA through its sixty-fifth meeting in 2005. It was
further decided that an updated and revised version of FNP 5 would not be published
separately as before, but would be incorporated into the FNP 52 Compendium second edition.
The new Compendium of Food Additive Specifications is therefore now comprised of four
volumes. The first three volumes are the food additive specifications themselves in
alphabetical order. This fourth volume includes the revised and updated analytical methods,
test procedures and laboratory solutions which first appeared in FNP 5, plus newer procedures
and an expanded section on laboratory instrumentation.

The review, revision and updating of the material in FNP 5, to prepare Volume 4, was a long
and arduous process. The Food and Agriculture Organization of the United Nations (FAO)
wishes to acknowledge and thank the following experts who were instrumental in the
preparation and finalization of this document: (Listed in alphabetical order)

(cid:2) Dr. Julie Barrows, US Food and Drug Administration, USA
(cid:2) Dr. Richard Cantrill, American Oil Chemists Society, USA.
(cid:2) Mr. John Howlett, Consultant, United Kingdom.
(cid:2) Dr. Paul Kuznesof, US Food and Drug Administration, USA
(cid:2) Dr. Keith Lampel, US Food and Drug Administration, USA
(cid:2) Mrs. Inge Meyland, Danish Institute of Food and Veterinary Research, Denmark.
(cid:2) Dr. Zofia Olempska-Beer, US Food and Drug Administration, USA
(cid:2) Dr. Madduri V. Rao, UAE University, United Arab Emirates.
(cid:2) Mrs. Harriet Wallin, National Food Agency, Finland
(cid:2) Dr. Brian Whitehouse, Consultant, United Kingdom

FAO also wishes to thank Consultant John Weatherwax, USA, who coordinated this effort
and who prepared the first three volumes of food additive specifications for publication.
Although several JECFA experts were involved in the revision and editing of those first three
volumes, FAO wishes to identify and thank two experts in particular, who both provided
significant contribution. They are Dr. Chris Fisher and Dr. Brian Whitehouse, both
Consultants residing in the United Kingdom.

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SPECIAL NOTE

The methods and analytical procedures described in this Compendium are designed to be
carried out by properly trained personnel in a suitably equipped laboratory. In common with
many laboratory procedures, the methods quoted frequently involve hazardous materials.

For the correct and safe execution of these methods it is essential that laboratory personnel
follow standard safety procedures for the handling of hazardous materials.

While the greatest care has been exercised in the preparation of this information, FAO
expressly disclaims any liability to users of these procedures for consequential damages of
any kind arising out of, or connected with, their use.

vii
COMBINED COMPENDIUM OF
FOOD ADDITIVE SPECIFICATIONS

INTRODUCTION

Introduction Contents

(cid:2) Foreword
(cid:2) Purpose and function of specifications of identity and purity of food additives
(cid:2) JECFA specifications and the Codex system
(cid:2) Specifications and methods of analysis
(cid:2) Format of specifications
(cid:2) General specifications and considerations for enzyme preparations used in food
processing
(cid:2) Tests and assays
(cid:2) Weights and measures
(cid:2) Abbreviations

FOREWORD
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) was established
following the recommendation of the first Joint FAO/WHO Conference on Food Additives
that the two organizations collect and disseminate information on food additives (Joint
FAO/WHO Conference on Food Additives, Report. FAO Nutrition Meetings Report Series,
No. 11; WHO Technical Report Series, No. 107, 1956). JECFA was first convened in 1956,
and has met annually, with a few exceptions, since that time.
As part of its work, JECFA establishes specifications of identity and purity for food additives.
These were originally published in FAO Nutrition Meetings Reports Series (NMRS), the
WHO Technical Report Series (TRS) or as FAO Food and Nutrition Papers (FNP). However
many of these are now out of print, and the first edition of this Compendium was published in
1992 in order to consolidate all of the then current JECFA specifications into a single
publication. Since 1992, separate Addenda to this Compendium have been published which
contain both newly established specifications and revisions to earlier specifications. The
original Compendium and the succeeding Addenda were all published in the FNP series as
number 52. This new Combined Compendium replaces the earlier edition and incorporates all
the additions and revisions made since 1992, up to and including those contained in FNP 52
Addendum 13. It is being published as the first document under a new publication series, the
FAO JECFA Monographs.
Many additive specifications have been revised two or more times as new information or
circumstances require. The specifications contained in this Combined Compendium are the
most recent version or revision for each additive. This new Combined Compendium is in four
volumes as follows:
(cid:2) Volume 1 – Specifications for food additives A through D.
(cid:2) Volume 2 – Specifications for food additives E through O.
(cid:2) Volume 3 – Specifications for food additives P through Z.
viii
(cid:2) Volume 4 – Analytical methods, test procedures and laboratory solutions used by and
referenced in the food additive specifications.
This Introduction is intended to replace and update the sections in the IPCS document
Principles for the Safety Assessment of Food Additives and Contaminants in Food
(Environmental Health Criteria 70 (EHC 70), WHO, 1987) that describe the purpose and
function of specifications of identity and purity of food additives. It also incorporates the
General Notices section of the Guide to Specifications originally published in Food and
Nutrition Paper 5 (FNP 5), revision 2. The remainder of FNP 5 has been extensively revised
and updated and is now included in Volume 4.
The term ‘specifications’ refers to the full set of individual specifications criteria for an
additive. Specifications are regarded as one of the outputs of JECFA’s risk assessment of
additives. The term ‘safety evaluation’ is used to describe the output of JECFA’s assessment
of the toxicology and other safety data relating to a food additive.
As previously noted, the specifications published in this Combined Compendium represent
the specifications current at the time of publication. These are, however, subject to future
review and revision as part of JECFA’s continuing work. New and revised specifications are
published as soon as practicable after the JECFA meetings when these were considered, and
JECFA specifications are also available online on the FAO website.
Specifications for flavouring agents are not included in this Compendium, excepting those
few which have an additional technological function as a food additive (e.g. carrier solvent).
Flavouring agent specifications will, however, still be available online in a searchable
database at the FAO website.
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PURPOSE AND FUNCTION OF SPECIFICATIONS OF IDENTITY
AND PURITY OF FOOD ADDITIVES

General
The specifications of identity and purity established by JECFA are intended to ensure that the
Committee’s safety evaluations apply, with a high degree of confidence, to all food additives
manufactured according to those specifications. In setting specifications, the Committee also
takes into account the need to encourage good manufacturing practice and to maintain the
quality of additives on the market, noting that these considerations may add to the assurance
of safety that the Committee is seeking as part of its risk assessment function.
JECFA’s specifications are also intended to set manufacturing standards for food additives
traded in international commerce either as such, or incorporated in food products. In some
cases, JECFA specifications will differ from specifications developed by other national and
international organizations. JECFA’s safety evaluations can, however, be taken to apply to
additives complying with these other specifications, provided that the additives are of equal
or higher purity than those required by the JECFA specifications, and provided that the test
criteria in the JECFA specifications are met.
The setting of specifications of identity and purity is an essential part of the risk assessment
of food additives, and current thinking emphasizes the need for the safety evaluation and the
specifications to be seen as joint outputs of the risk assessment process. The safety
evaluation of an additive should therefore always be read in conjunction with the
specifications of identity and purity that describe the additive. The link between the two parts
of the risk assessment process is also emphasized by the fact that the latest safety evaluation
is quoted in each of the specifications, together with a reference to the JECFA meetings(s) at
which the specifications were elaborated and the safety evaluation carried out.
Formulation of Specifications and Information Requirements
The formulation of satisfactory specifications requires detailed information to be made
available to the Committee on the method of manufacture of the additive, including
information on raw materials and on its chemical characterization. The Committee requires
such information to be provided as part of the total data package whenever an additive is
submitted for risk assessment, and all such information will be regarded as suitable for
making publicly available unless requested otherwise and agreed by the Secretariat. Those
submitting data for a JECFA evaluation are advised to consult existing specifications for
further guidance, taking note also of the format of specifications described later in this
introduction. They should also seek further advice as needed from the JECFA Secretariat.

Specifications may be revised where there is new information available on methods of
manufacture or on the characteristics of the substance, or where changes or revisions in
analytical methods are needed. Such changes may also prompt a review of the safety
evaluation. Similarly, a review of the specifications may be needed if the safety evaluation is
reconsidered.
Additives are mainly defined by a combination of (i) a description of their manufacture, (ii) a
minimum requirement for the content of the principal functional component(s) of the
additive, and (iii) maximum limits for undesirable impurities. The relative importance of
these criteria, however, depends on the nature of the additive. Thus, for example, additives
composed largely of single components are mainly defined in terms of their chemical purity,