TOXICOLOGICAL EVALUATION OF CERTAIN FOOD ADDITIVES
WHO FOOD ADDITIVES SERIES 10
The evaluations contained in this document were prepared by the
Joint FAO/WHO Expert Committee on Food Additives*
Rome, 21-29 April 1976
Food and Agriculture Organization of the United Nations
World Health Organization
*Twentieth Report of the Joint FAO/WHO Expert Committee on Food
Additives, Geneva, 1976, WHO Technical Report Series No. 599, FAO Food
and Nutrition Series No. 1.
CONTENTS
INTRODUCTION
ALLOCATION OF ACCEPTABLE DAILY INTAKES (ADI)
TOXICOLOGICAL EVALUATION: FOOD COLOURS
THE MONOGRAPHS
Butylated hydroxyanisole
Butylated hydroxytoluene
Diethylene glycol monoethyl ether
Gallates, dodecyl, octyl, propyl
Glycerol and glycerol diacetate
Menthol
Mineral oil (food grade)
Natamycin (Pimoricin(R))
Nitrites, sodium and potassium salts
Sucrose esters of fatty acids and sucroglycerides
Trichloroethylene
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 Twentieth 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 Rome from 21 to 29 April 1976. 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 Safety Unit
World Health Organization
Avenue Appia
1211 Geneva, Switzerland
1 Twentieth Report of the Joint FAO/WHO Expert Committee on Food
Additives. FAO Nutrition Meetings Report Series No. 1 Wld Hlth
Org. techn. Rep. Ser., 1976, 599
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)
butylated hydroxyanisole 0-0.51,2
butylated hydroxytoluene 0-0.51,2
diethylene glycol monoethyl ether No ADI allocated
gallates, totecyl, octyl, propyl 0-0.21,3
glycerol Not specified4
glycerol diacetate Not specified4
menthol 0-0.2
mineral oil (food grade) Not specified4
nitrites, sodium and potassium salts 0-0.21,5
natamycin (PimencinR) 0-0.3
sucrose esters of fatty acids 0-2.56
sucroglycerides 0-2.56
trichloroethylene No ADI allocated7
1 Temporary.
2 As BHA, BHT, or the sum of the two chemicals.
3 Applicable to individual gallates or their sum. (Note: n-octyl
gallate should not be used in beverages.)
4 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.
5 Food for babies less than six months old should not contain
added nitrites.
6 As sucrose esters of fatty acids, sucroglycerites, or the sum
of both.
7 The permitted use as an extractant is withdrawn.
See Also:
Toxicological Abbreviations