FAO Nutrition Meetings
Report Series No. 48A
WHO/FOOD ADD/70.39
TOXICOLOGICAL EVALUATION OF SOME
EXTRACTION SOLVENTS AND CERTAIN
OTHER SUBSTANCES
The content of this document is the
result of the deliberations of the Joint
FAO/WHO Expert Committee on Food Additives
which met in Geneva, 24 June -2 July 19701
Food and Agriculture Organization of the United Nations
World Health Organization
1 Fourteenth report of the Joint FAO/WHO Expert Committee on Food
Additives, FAO Nutrition Meetings Report Series in press; Wld Hlth
Org. techn. Rep. Ser., in press.
CONTENTS
INTRODUCTION
ALLOCATION OF ACCEPTABLE DAILY INTAKES
TOXICOLOGICAL EVALUATIONS: MISCELLANEOUS FOOD ADDITIVES AND
CONTAMINANTS
TOXICOLOGICAL EVALUATIONS: FILTRATION AIDS AND RELATED SUBSTANCES
TOXICOLOGICAL EVALUATIONS: EXTRACTION SOLVENTS
THE MONOGRAPHS
MISCELLANEOUS FOOD ADDITIVES AND CONTAMINANTS
Brominated Vegetable Oils
Calcium Cyclamate and Sodium Cyclamate (including Cyclohexylamine)
Cyclohexylamine
Saccharin
Copper and Cupric Sulphate
Ethyl Maltol
Food-Grade Mineral Oil
Monosodium Glutamate
Oleoresins of Paprika
Phosphoric Acid, Phosphates and Polyphosphates
Tin and Stannous Chloride
FILTRATION AIDS AND RELATED SUBSTANCES
Activated Vegetable Carbon (Food Grade)
Tannin (Food Grade)
EXTRACTION SOLVENTS
Acetone
1,2-Dichloroethane
Dichloromethane
Ethanol
Methanol
Petroleum Hydrocarbon Fractions (Hexane and Heptane)
Propan-2-OL
Trichlorethylene
ANNEX 1
INTRODUCTION
The monographs contained in this paper are the result of the
deliberations of the Joint FAO/WHO Expert Committee on Food Additives
which met in Geneva from 24 June to 2 July 1970. Since the report 1
of this meeting also contains comments on groups of as well as
individual substances considered, these monographs should be read in
conjunction with the report.
Any new information and comments relating to the biological data
and their evaluation should be addressed to: Food Additives Unit,
World Health Organization Avenue Appia, Geneva, Switzerland.
Specifications on the food additives considered have been
prepared, and these will be issued in a separate document entitled
"Specifications for the Identity and Purity of Some Extraction
Solvents and Certain Other Substances".2 Comments relating to
specifications should be addressed to: Food Policy and Feed Science
Service, Nutrition Division, FAO, Rome, Italy.
1 14th Report of the Joint FAO/WHO Expert Committee on Food
Additives: FAO Nutrition Meetings Report Series, in press.; Wld
Hlth Org. techn. Rep. Ser., in press.
2 FAO Nutrition Meetings Report Series, 49B
WHO/Food Add./71.40 (in preparation)
ALLOCATION OF ACCEPTABLE DAILY INTAKES
It is generally recognized that all chemicals are toxic to
animals and man if large enough amounts are administered. Even those
so called innocuous substances, when given in excessive doses, may
induce untoward effects as a result various non-specific actions,
e.g. physical obstruction of the G.I. tract, alteration of osmotic
pressure and nutritional imbalance. A limit on the daily intake of a
substance is therefore essential for the protection of the health of
the consumer. The Committee therefore followed previous practice where
appropriate in allocating acceptable daily intakes to the food
additives considered.
An unconditional ADI was allocated only to those substances for
which the biological data available included either the results of
adequate short-term and long-term toxicological investigations or
information on the biochemistry and metabolic fate of the compound or
both.
A conditional ADI was allocated for specific purposes arising
from special dietary requirements.
A temporary ADI was allocated when the available data were not
fully adequate to establish the safety of the substance and it was
considered necessary that the additional evidence be provided within a
stated period of time. If the further data requested do not become
available within the stated period, it is possible that the temporary
ADI will be withdrawn by a future Committee.
Whereas all the ADIs are subject to periodic review, especially
when additional data are available, reconsideration of temporary ADIs
is obligatory after the date specified. The decision arrived at will
depend on the information available at the time of review. It is
certainly not intended that the temporary status of the ADI for a food
additive will continue to be maintained indefinitely.
For those additives for which the available information was
grossly inadequate to establish safety, no ADI was allocated.
On the other hand, the Committee took cognizance of the fact that
the level of use of certain food additives is limited by good
manufacturing practice and that they possess a very low toxicity. For
these additives the Committee established no limit except as based on
good manufacturing practice.
TOXICOLOGICAL EVALUATIONS: MISCELLANEOUS FOOD ADDITIVES AND
CONTAMINANTSa
Substance Acceptable daily
intake for man1
(mg/kg body-weight)
Brominated vegetable oilsb No ADI
Carrageenanc ) 0-502
Furcellaran )
Cyclamates, calcium and sodiumd No ADI3
Copper and cupric sulfatee No ADI4
Ethyl maltole 0-2
Food grade mineral oile Use limited by good
manufacturing practice
Mercurial compounds No ADI
Monosodium L-glutamatee 0-1205
Oleoresins of paprikae Self limiting as a spice
Phosphoric acid and phosphatesf 0-306
Tin and stannous chloridee No ADI4
a Specifications are also available for gelatine mid sodium
caseinate.
b Identification test only.
c Specifications available (Annex 1, ref. 21).
d Specifications available (Annex 1, ref. 16; also Section 5.3.1(b)).
c Specifications available (see P. 3).
e Specifications available (see Annex 1, ref. 7).
1 Unconditional ADIs unless otherwise indicated.
2 As carrageenan or furcellaran, or the sum of both. (There was a
printing error in the thirteenth report (Annex 1. ref. 19) but the
monographs (Annex 1, ref. 20) are correct).
3 Use in the management of diabetes and gross obesity not considered
in this evaluation.
4 For evaluation see section 5.3.3.
5 Additional to the amount naturally occurring in the diet.
Applicable to the general population except infants under one year
of age.
6 Conditional acceptable daily intake 30-70 mg/kg. Both the
unconditional and conditional ADIs include the amount occurring in
the diet.
TOXICOLOGICAL EVALUATIONS: FILTRATION AIDS AND RELATED SUBSTANCES
Substances Acceptable daily
intake for man
(mg/kg body-weight)
Activated vegetable carbonsa No limit except for good
(food grade) manufacturing practice
Asbestos Decision postponedc
Tannins (food grade)b
Derived from Peruvian tara 0-0.6d
Derived from Turkish aleppo,
Chinese tara, and 0-0.3d
Sicilian sumac
a Specification available (see p. 6).
b Tentative specifications available (see p. 6) when used as a
flocculant.
c See the fourteenth report of the Joint FAO/WHO Expert Committee on
Food Additives: FAO Nutrition Meetings Report Series,; Wld Hlth
Org. techn. Rep. Ser.,(in press).
d Temporary ADI.
TOXICOLOGICAL EVALUATIONS: EXTRACTION SOLVENTS
1. Substances considered
Acetone Petroleum hydrocarbon
1,2-Dichlorethane fractions (heptane and hexane)
Dichloromethane Propan-2-ol
Ethanol 1,1,2-Trichloroethylene
Methanol
2. Evaluations
(a) The evaluations for these solvents, with the exception of
trichloroethylene as a caffeine extractant and ethanol, are tentative,
and are subject to re-evaluation when the relevant data become
available (see section 4.3.1).
(b) These solvents should be used only in accordance with good
manufacturing practice, in the expectation that this will result in
minimal residues.
(c) With 1,2-dichloroethane and 1,1,2-trichloroethylene, care
must be taken to avoid the formation of toxic interaction products
with certain treated foods.
3. Specifications available for all these solvents with the exception
of hexane and heptane, for which only tentative specifications were
prepared.