INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
FOOD ADDITIVES AND FOOD CONTAMINANTS
WHO FOOD ADDITIVES SERIES 19
Rome, 19-28 March 1984
The International Programme on Chemical Safety (IPCS),
established in 1980, is a joint venture of the United Nations
Environment Programme (UNEP), the International Labour Organisation
(ILO), and the World Health Organization (WHO). The overall objectives
of the IPCS are to establish the scientific basis for assessment of
the risk to human health and the environment from exposure to
chemicals, through international peer-review processes, as a
prerequisite for the assistance in strengthening national capacities
for the sound management of chemicals.
The Inter-Organization Programme for the Sound Management of
Chemicals (IOMC) was established in 1995 by UNEP, ILO, the Food and
Agriculture Organization of the United Nations, WHO, the United
Nations Industrial Development Organization and the Organisation for
Economic Co-operation and Development (Participating Organizations),
following recommendations made by the 1992 UN Conference on
Environment and Development to strengthen cooperation and increase
coordination of the policies and activities pursued by the
Participating Organizations, jointly or separately, to achieve the
sound management of chemicals in relation to human health and the
WHO Food Additives Series, 1984, No 19
TOXICOLOGICAL EVALUATION OF CERTAIN FOOD ADDITIVES
The evaluations contained in this document
were prepared by the Joint FAO/WHO
Expert Committee on Food Additives*
Rome, 19-28 March 1984
INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
* Twenty-eighth report of the Joint FAO/WHO Expert Committee on
Food Additives, Geneva, Wld Hlth Org. techn. Rep. Ser., 710,
The monographs contained in this document have been prepared by
the Joint FAO/WHO Expert Committee on Food Additives which was held in
Rome, 19-28 March 1984.
The printing of this document has been possible through the
financial contribution of the International Programme on Chemical
Safety (IPCS) and the editing through the financial assistance of the
International Life Science Institute (ILSI) which permitted to the
Central Unit of the IPCS to engage an editor for the purpose.
Apreciation is expressed to the Directors of the Lead
Institutions of the IPCS collaborating in supporting the preparatory
activities of JECFA's WHO side for allowing the experts acting as
Temporary Advisers time to carry out their duties.
A special acknowledgment is given to the following experts for
preparing the drafts of the monographs: Professor C.L. Galli, Istituto
di Farmacologia e Farmacognosia, UniversitÓ di Milano, Italy; Dr. J.E.
Long, Food Directorate, Health Protection Branch, Department of Health
and Welfare, Ottawa, Ontario, Canada; Dr. S.I. Shibko, Director
Division of Toxicology, Bureau of Food and Drug Administration,
Washington DC, USA; Dr. R. Walker, Department of Biochemistry,
University of Surrey, Guildford, U.K.
Any comment or new information on the biological and
toxicological data on the compounds reported in this document should
be addressed to: Joint WHO Secretary of the joint FAO/WHO Expert
Committee on Food Additives, International Programme on Chemical
Safety, World Health Organisation, Avenue Appia, 1211 Geneva 27,
For rights of reproduction of this document, in part or in
toto, application should be made to the International Programme on
Chemical Safety (IPCS), World Health Organisation, Geneva,
The disignations employed and the presentation of the material in
this publication do not imply the expression of any opinion whatsoever
on the part of the Central Unit of the International Programme on
Chemical Safety concerning the legal status of any country, territory,
city or area or of its authorities, or concerning the delimitation of
its frontiers or boundaries.
The mention of specific companies or of certain manufacturers'
products does not imply that they are endorsed or recommended by the
International Programme on Chemical Safety in preference to others of
a similar nature that are not mentioned.
JOINT FAO/WHO EXPERT COMMITTEE ON FOOD ADDITIVES
Rome, 19-28 March 1984.
Members invited by FAO
Dr. W.H.B. Denner, Principal Scientific Officer, Food Science
Division, Ministry of Agriculture, Fisheries and Food, London,
Dr. S.W. Gunner, Director, Bureau of Chemical Safety, Food
Directorate, Health Protection Branch, Department of National
Health and Welfare, Ottawa, Canada (Chairman).
Professor K. Kojima, College of Environmental Health, Azabu
University, Sagamihara-Shi, Kanagawa, Japan.
Dr. J.P. Modderman, Food Additive and Animal Drug Chemistry,
Department of Health and Human Sciences, Food and Drug
Administration, Washington DC, USA.
Professor F.J. Pellerin, Faculty of Pharmacy, University of Paris XI,
Centre hospitalier Corentin-Celton, Issy-les-Moulineaux, France.
Members invited by WHO
Dr. H. Blumenthal, Director, Division of Toxicology, Bureau of Foods,
Food and Drug Administration, Washington DC, USA.
Professor E. Fournier, Professor of Clinical Toxicology,
H˘pital Fernand-Widal, Paris, France.
Dr. G. Nazario, Department of Food Standards, National
Health Council, Rio de Janeiro, Brazil. Sao Paulo, Brazil.
Dr. P. Pothisiri, Director, Technical Division, Food and Drug
Administration, Ministry of Public Health, Bangkok, Thailand.
Professor M.J. Rand, Head, Department of Pharmacology, University of
Melbourne, Victoria, Australia (Vice-Chairman).
Dr. A.N. Zaicev, Head, Laboratory of the Hygienic Examination of Food
Additives, Institute of Nutrition, Academy of Medical Sciences,
Observers invited by FAO
Mr. A. Feberwee, Chairman, Codex Committee on Food Additives, Ministry
of Agriculture and Fisheries, The Hague, The Netherlands.
Dr. R. Mathews, Director, Food Chemicals Codex, National Academy of
Sciences, Washington DC, USA.
Dr. C.L. Galli, Professor of Experimental Toxicology, University of
Milan, Italy (WHO Temporary Adviser).
Mr. Y. Hayashi, Director, Division of Pathology, Biological Safety
Research Centre, National Institute of Hygienic Sciences, Tokyo,
Japan (WHO Temporary Adviser).
Dr. J.E. Long, Head, Toxicological Evaluation Division, Health
Protection Branch, Department of National Health and Welfare,
Ottawa, Canada (WHO Temporary Adviser).
Dr. B. MacGibbon, Senior Principal Medical Officer, Division Of
Toxicology, Environmental Pollution and Prevention, Department of
Health and Social Security, London, U.K. (rapporteur).
Professor I. Nir, Department of Pharmacology and Experimental
Therapeutics, Hadassah Medical School, Hebrew University,
Jerusalem, Israel (WHO Temporary Adviser).
Mr. Pearce, Director of Technical Services, Williams (Hounslow)
Limited, London, England (FAO Consultant).
Dr. A.W. Randell, Food Policy and Nutrition Division, FAO, Rome, Italy
Dr. N. Rao Maturo, Food Standards Officer, Food Policy and Nutrition
Division, FAO, Rome, Italy.
Dr. S.I. Shibko, Associate Director of Regulatory Evaluation, Division
of Toxicology, Bureau of Food and Drug Administration, Washington
DC, USA (WHO Temporary Adviser).
Dr. P. Shubik, Resident Fellow, Green College, University of Oxford,
England (WHO Temporary Adviser).
Professor K. Topsy, Beau Bassin, Mauritius (WHO Temporary Adviser)
Dr. G. Vettorazzi, Toxicologist, International Programme on Chemical
Safety, Division of Environmental Health, WHO, Geneva,
Switzerland (Joint Secretary).
Dr. R. Walker, Department of Biochemistry, University of Surrey,
Guildford, England (WHO Temporary Adviser).
Mr. J. Wilbourn, Unit of Carcinogen Identification and Evaluation,
International Agency for Research on Cancer, Lyons, France.
ACCEPTABLE DAILY INTAKES AND INFORMATION ON SPECIFICATIONS
ADI for man (mg/kg
Specifications1 of body weight) [and
A. SPECIFIC FOOD ADDITIVES
Anoxomer ST 0-8
violaceoniger) R ADI not specified2
fradiae) S ADI withdrawn3
Trans-anethole R 0-2.54
Cinnamaldehyde R 0-0.74
glycidate R 0-0.5
alpha-Ionone S 0-0.15
beta-Ionone R 0-0.15
Nonanal O 0-0.16
Octanal R 0-0.16
Amaranth R 0-0.5
Brown HT R 0-1.5
Erythrosine R 0-1.254
Quinoline Yellow RT 0-10
2-Nitropropane ST Temporary acceptance7
Triethyl citrate R 0-20
Saccharin S 0-2.54/8
Saccharin, calcium S 0-2.54/8
Saccharin, potassium N 0-2.54/8
Saccharin, sodium S 0-2.54/8
furcellaran RT ADI not specified2
Tara gum R 0-12.54
Potential migrants from food-contact materials
Acrylonitrile Provisional acceptance9
phthalate Provisional acceptance9
Vinyl chloride Provisional acceptance9
1 N, new specifications prepared; O, specifications not prepared;
R, existing specifications revised; S, specifications exist,
revision not considered or not required; the existing, new, or
revised specifications are tentative and comments are invited.
2 The statement "ADI not specified" means that, on the basis of
the available data (chemical, biochemical, toxicological, and
other), the total daily intake of the substance, arising from its
use 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 that reason,
and for reasons stated in the individual evaluations, the
establishment of an acceptable daily intake (ADI) is not deemed
3 Insufficient toxicological data available.
4 Temporary acceptance.
5 Group ADI for alpha-ionone and beta-ionone, singly or in
6 Group ADI for octanal and nonanal, singly or in combination.
7 The previous recommendation that 2-nitropropane should not be
used as a solvent in food processing changed to temporary
acceptance for use as a fractionating solvent for edible fats and
oils only, with the stipulation that residue levels are kept to
the lowest technologically attainable, which is understood to be
lower than the detection limit by current analytical methods.
8 Group ADI for saccharin, saccharin calcium, saccharin sodium,
and saccharin potassium, singly or in combination.
9 The use of food-contact materials from which the substance may
migrate is provisionally accepted, on condition that the amount
of the substance migrating into the food is reduced to the lowest
level technologically attainable.
10 This figure represents the provisional maximum tolerable daily
intake (PMTDI) of styrene. It is not an ADI. The MTDI for styrene
is provisionally accepted under the same conditions as those set
out in Note 9.
11 The existing specifications for some salts of fatty acids are
incorporated in the new specifications.
12 Replaces the specification for methyl violet, of which the
colour crystal violet is a purified compound.
13 The existing specifications incorporated into a single
specification covering a series of related substances.
14 No knowledge of the continuing use of the colour in food and no
information received with regard to the specifications over a
long period of time.
15 No ADI allocated because of insufficient data.
16 The colour is little used and it is understood its use will be
17 Specifications withdrawn at previous meetings.
Carrageenan and furcellaran
Glucose isomerase (isolated from Streptomyces violaceoniger)
alpha- and ▀-Ionone
Saccharin, calcium, potassium and sodium salts
Bis (2-ethylhexyl) phtbalate
* Monograph addendum