WORLD HEALTH ORGANIZATION
Toxicological evaluation of some food colours, thickening
agents, and certain other substancse
WHO FOOD ADDITIVES SERIES NO. 8
The evaluations contained in this publication were prepared
by the Joint FAO/WHO Expert Committee on Food Additives which
met in Geneva, 14-23 April 19751
World Health Organization, Geneva 1975
1 Nineteenth Report of the Joint FAO/WHO Expert Committee on Food
Additives, Wld Hlth Org. techn. Rep. Ser., 1975, No. 576;
FAO Nutrition Meetings Report Series, 1975, No. 55.
The monographs contained in the present volume are
also issued by the Food and Agriculture Organization
of the United Nations, Rome, as
FAO Nutrition Meetings Report Series, No. 55A
ISBN 92 4 166008 2
(C) FAO and WHO 1975
CONTENTS
INTRODUCTION
ALLOCATION OF ACCEPTABLE DAILY INTAKES (ADI)
TOXICOLOGICAL EVALUATION: FOOD COLOURS
TOXICOLOGICAL EVALUATION: THICKENING AGENTS
TOXICOLOGICAL EVALUATION: MISCELLANEOUS FOOD ADDITIVES
THE MONOGRAPHS
FOOD COLOURS
Amaranth
Ferrous gluconate
Quinoline Yellow
THICKENING AGENTS
Gum, carob bean
Gum, guar
Gum, tara
Microcystalline cellulose
Pectin (amidated)
MISCELLANEOUS FOOD ADDITIVES
Dichlorodifluoromethane
Tertiary butyl hydroquinone (TBHQ)
Triacetin
ANNEX 1. Reports and other documents resulting from previous
meetings of the Joint FAO/WHO Expert Committee on Food Additives
ANNEX 2. Membership of the Nineteenth Joint FAO/WHO Expert
Committee on Food Additives
INTRODUCTION
The monographs contained in this document are the result of the
deliberations of the Joint FAO/WHO Expert Committee on Food Additives
which met in Geneva, from 14 to 23 April 1975. Since the report1 of
this meeting contains comments on the same substances, these
monographs should be read or consulted in conjunction with the report.
The present monographs follow the standard format adopted by the
FAO/WHO Expert Committee on Food Additives when dealing with the
toxicological evaluation of food additives. Each monograph attempts to
provide, in a condensed form, as full an account as possible of all
the biochemical and toxicological data made available to the Expert
Committee on Food Additives at the time of the meeting. Some of the
substances examined at this meeting have been evaluated in previous
meetings. Monographs formerly published on the same compounds have
been incorporated, in a revised form, into the monographs contained in
this document. References to previous monographs are found in the
introductory explanation at the beginning of each monograph and a
comprehensive list of earlier publications is provided in Annex 1 of
this document.
As a number of food additives are closely related chemically and
toxicologically, the Committee at its Seventeenth meeting adopted the
same position that has been adopted in its seventh and later reports,
that of a system of grouping additives for purposes of evaluation.
When a given food additive is related to two or more groups, its level
in the diet must not exceed the maximum acceptable level for either
group.
Any new information and comments on the biological data and their
evaluation should be addressed to:
Division of Environmental Health
Food Additives Unit
World Health Organization
Avenue Appia
1211 Geneva, Switzerland
1 Nineteenth Report of the Joint FAO/WHO Expert Committee on Food
Additives. FAO Nutrition Meetings Report Series No. 55; Wld Hlth
Org. techn. Rep. Ser., 1975, No. 576.
ALLOCATION OF ACCEPTABLE DAILY INTAKES (ADI)
The acceptable daily intake (ADI) for man, expressed on a body
weight basis, is the amount of a food additive that can be taken daily
in the diet, even over a lifetime, without risk.
An ADI is allocated only to substances for which the available
data include either the results of adequate short-term and long-term
toxicological investigations or satisfactory information on the
biochemistry and metabolic fate of the compound, or both.
An ADI may be allocated temporarily, pending the provision of
additional data within a stated period of time. This measure implies
that the toxicological data are adequate to ensure the safety in use
of the additive during the time for which the temporary ADI applies.
If the additional data requested do not become available within the
stated period, the temporary ADI may be withdrawn at a future meeting
of the Committee.
An ADI without an explicit indication of the upper limit of
intake ("ADI not specified") may be assigned to substances of very low
toxicity, especially those that are food constituents or that may be
considered as foods or normal metabolites in man. The expression "ADI
not specified" has been adopted by the Joint FAO/WHO Expert Committee
on Food Additives at its Eighteenth session as a more suitable
expression than "ADI not limited" previously used. However, an
additive having an "ADI not specified" must meet the criteria of good
manufacturing practice for example it should have proven technological
efficacy and be used at the minimum level of efficacy, it should not
conceal inferior food quality or adulteration, and it should not
create a nutritional imbalance.
The expression "No ADI allocated" is applicable to substances for
which the available information is not sufficient to establish their
safety or when the specifications are not adequate to establish their
identity.
The expression "Not to be used" is applicable to substances for
which there is sufficient information on which to base such decision.
There may be circumstances in which the ADI is not applicable.
Thus it may be exceeded for special dietary purposes for example, in
the case of modified celluloses, to reduce the energy content of the
diet. On the other hand, the ADI for glutamic acid and glutamates does
not extend to foods for infants under three months old.
In previous reports a conditional ADI was allocated to a number
of substances, often in addition to an unconditional ADI. Variations
in the rules for applying conditional ADIs have given rise to some
confusion. For this reason, the Committee considers that the
allocation of conditional ADIs should be abandoned.
ADIs are intended as guides only and may be exceeded, after
consultation with experts, in circumstances in which there may be
important advantages in doing so. In the opinion of the Committee, an
ADI provides a sufficiently large safety margin to ensure that there
need be no undue concern about occasionally exceeding it provided the
average intake over longer periods of time does not exceed it.
TOXICOLOGICAL EVALUATION: FOOD COLOURS
Acceptable daily
intake for man
Substances (mg/kg bw)
Amaranth 0-0.751
Ferrous gluconate Not specified2,3
Quinoline yellow 0-0.51
1 Temporary.
2 The statement "ADI not specified" means, that, on the basis of
the available data (toxicological, biochemical, and other), the total
daily intake of the substance, arising from its use or uses at the
levels necessary to achieve the desired effect and from its acceptable
background in food, does not, in the opinion of the Committee,
represent a hazard to health. For this reason, and for the reasons
stated in individual evaluations, the establishment of an acceptable
daily intake (ADI) in mg/kg bw is not deemed necessary.
3 However, the contribution from ferrous gluconate to the total
dietary gluconic acid intake from all sources should be included in
the ADI for gluconic acid (0-50 mg/kg body weight).
TOXICOLOGICAL EVALUATION: THICKENING AGENTS
Acceptable daily
Substances intake for man
(mg/kg bw)
Gum, carob bean Not specified1,2
Gum, guar Not specified2
Gum, tara Not specified1,2
Microcrystalline cellulose Not specified2
Pectin (amidated) 0-251
1 Temporary
2 The statement "ADI not specified" means that, on the basis of
the available data (toxicological, biochemical, and other), the total
daily intake of the substance, arising from its use or uses at the
levels necessary to achieve the desired effect and from its acceptable
background in food, does not, in the opinion of the Committee,
represent a hazard to health. For this reason, and for the reasons
stated in individual evaluations, the establishment of an acceptable
daily intake (ADI) in mg/kg bw is not deemed necessary.
TOXICOLOGICAL EVALUATION: MISCELLANEOUS FOOD ADDITIVES
Acceptable daily
Substances intake for man
(mg/kg bw)
Dichlorofluoromethane 0-1.5
Tertiary butyl hydroquinone 0-0.751
Triacetin Not specified2
1 Temporary.
2 The statement "ADI not specified" means that, on the basis of
the available data (toxicological, biochemical, and other) the total
daily intake of the substance, arising from its use or uses at the
levels necessary to achieve the desired effect and from its acceptable
background in food, does not, in the opinion of the Committee,
represent a hazard to health. For this reason, and for the reasons
stated in individual evaluations, the establishment of an acceptable
daily intake (ADI) in mg/kg bw is not deemed necessary.
See Also:
Toxicological Abbreviations