INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF SOME
FOOD COLOURS, EMULSIFIERS, STABILIZERS,
ANTI-CAKING AGENTS AND CERTAIN
OTHER SUBSTANCES
FAO Nutrition Meetings Report Series
No. 46A WHO/FOOD ADD/70.36
The content of this document is the result of the deliberations of the
Joint FAO/WHO Expert Committee on Food Additives which met in Rome,
27 May - 4 June 19691
Food and Agriculture Organization of the United Nations
World Health Organization
1 Thirteenth 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
ACCEPTABLE DAILY INTAKES (ADI) FOR MAN OF SOME FOOD COLOURS
ACCEPTABLE DAILY INTAKES (ADI) FOR MAN OF MODIFIED STARCHES
ACCEPTABLE DAILY INTAKES (ADI) FOR MAN OF SOME EMULSIFIERS AND
STABILIZERS
ACCEPTABLE DAILY INTAKES (ADI) FOR MAN OF SOME ANTI-CAKING AGENTS
ACCEPTABLE DAILY INTAKES (ADI) FOR MAN OF CERTAIN OTHER FOOD ADDITIVES
THE MONOGRAPHS
FOOD COLOURS
Annatto Extracts
Chlorophyll
Chlorophyll Copper Complex and Chlorophyllin Copper Complex, Sodium
and Potassium Salts
Quercetin and Quercitron
Riboflavin
Turmeric
Brilliant Blue FCF
Brilliant Black BN
Citrus Red 2
Erythrosine
Fast Green FCF
Indanthrene Blue
Indigotine
Orange 1
Patent Blue V
Ponceau 4R
Quinoline Yellow
Titanium Dioxide
Woolgreen BS
MODIFIED STARCHES
Amylose and Amylopectin
Enzyme-Treated Starches
White and Yellow Dextrins
Acid-Treated Starches
Bleached Starches
Oxidized Starches
Alkali-Treated Starch
Mono Starch Phosphate
Starch Acetate
Starch Sodium Succinate
Hydroxypropyl Starch
Supplementary Information - Propylene Chlorohydrin
Distarch Phosphate (prepared using Phosphorus Oxychloride)
Distarch Phosphate (prepared using Sodium Trimetaphosphate)
Phosphated Distarch Phosphate
Acetylated Distarch Phosphate
Hydroxypropyl Distarch Phosphate
Distarch Glycerol
Acetylated Distarch Glycerol
Hydroxypropyl Distarch Glycerol
Acetylated Distarch Adipate
EMULSIFIERS AND STABILIZERS
Carrageenan and Furcellaran
Arabic Gum
Carob Bean Gum
Guar Gum
Karaya Gum
Tragacanth Gum
Polyglycerol Esters of Interesterified Ricinoleic Acid
Stearoyl Lactylate, Calcium Salt, and Stearoyl Lactylate, Sodium Salt
Stearyl Citrate
Sucrose Esters of Fatty Acids
Supplementary Information - Dimethyl Formamide
Hydroxylated Lecithin
Ammonium Salts of Phosphatidic Acids
Hydroxypropyl Cellulose
Pectin
Propylene Glycol Alginate
ANTI-CAKING AGENTS
Calcium, Sodium and Potassium Ferrocyanide
Calcium and Magnesium Phosphates Tribasic
Salts of Myristic, Palmitic and Stearic Acid with Bases Accepted for
Food Use
Silicon Dioxide, Amorphous; Aluminium-; Calcium-; Magnesium-; Sodium
Alumino-; Silicates
CERTAIN OTHER FOOD ADDITIVES
Calcium Sulphate
Ascorbyl Stearate
Dimethylpolysiloxane
Oxystearin
Nordihydroguaiaretic Acid
ANNEX 1 - Reports and other documents resulting from Previous meetings
of the Joint FAO/WHO Expert Committee on Food Additives
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 Rome from 27 May to 4 June 1969. Since the report1 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 Food Colours,
Emulsifiers and Stabilizers, Anti-caking Agents and Certain Other
Substances".2 Comments relating to specifications should be
addressed to: Food Standards, Additives and Regulations Section,
Nutrition Division, FAO, Rome, Italy.
1 13th 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, No. 46B; WHO/Food
Add./70.37
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 these so-called
innocuous substances, when given in excessive doses, may induce
untoward effects as a result of 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 ADI's are subject to periodic review, especially when
additional data are available, reconsideration of temporary ADI's 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.
A few chemicals were considered, on the basis of available
toxicological information, to be unsuitable for use as food additives.
ACCEPTABLE DAILY INTAKES (ADI) FOR MAN OF SOME FOOD COLOURS
Substance ADI
(mg/kg body weight)
Annatto Extractsa 0 - 1.251
Chlorophylla No limit2
Chlorophyll Copper Complexa ) 0 - 15
)
Chlorophyllin Copper Complex, )
Sodium & Potassium Saltsa,c ) 0 - 151
Quercetin & Quercitronb No ADI
Riboflavina 0 - 0.5
Turmeric 0 - 0.51
Brilliant Blue FCFb 0 - 12.5
Brilliant Black BNb No ADI
Citrus Red No. 2b Not to be used
Erythrosina 0 - 1.251
Fast Green FCFb 0 - 12.5
Indanthrene Blueb 0 - 11
Indigotineb 0 - 2.51
Orange Ib No ADI
Patent Blue Vb 0 - 11
Ponceau 4Rb 0 - 0.751
Quinoline Yellowb 0 - 11
Titanium dioxideb No limit2
Woolgreen BSb 0 - 51
a Specifications will be published for these compounds (see Annex
1, Ref. 19).
b Specifications are available for these substances (see Annex 1,
Ref. 10).
c Tentative specification.
1 Temporary acceptable daily intakes - details on further
information required are given in the respective monographs.
2 Not limited except by good manufacturing practice.
Note: For caramel, curcumin and Yellow 2G no monographs were
prepared for reasons given in section 3.1 of the 13th Report (see
Annex 1, Ref. 18).
ACCEPTABLE DAILY INTAKES (ADI) FOR MAN OF MODIFIED STARCHES
Substancea ADI
(mg/kg body weight)
Amylose, amylopectin No limit2
Enzyme-treated starches No limit2
White and yellow dextrins No limit2
Acid-treated starches No limit2
Bleached starches No limit2
Oxidized starches No limit1,2
Alkali-treated starches No limit2
Mono starch phosphate No limit2,4
Starch acetate 0 - 12.51
Starch sodium succinate No ADI
Hydroxypropyl starch 0 - 251
Distarch phosphate (phosphorous
oxychloride) No ADI
Distarch phosphate
(sodium-trimelaphosphate) 0 - 253,4
Phosphated distarch phosphate 0- 253,4
Acetylated distarch phosphate No ADI
Hydroxypropyl distarch phosphate No ADI
Distareh glycerol No ADI
Acetylated distarch glycerol No ADI
Hydroxypropyl distarch glycerol 0 - 12.51
Acetylated distarch adipate 0 - 12.51
a Specifications will be published for these compounds (see Annex
1, Ref. 19) except for the first three items. The specifications
are tentative for those items which have not been given an ADI.
1 Temporary acceptable daily intakes - details on further
information required are given in the respective monographs.
2 Not limited except by good manufacturing practice.
3 As distarch phosphate (sodium-trimetaphosphate) or phosphated
distarch phosphate or the sum of both.
4 Subject to limits of phosphorous load (see Annex 1, Ref. 7,
p. 32).
Note: No monographs were prepared for certain other modified
starches (see Annex 1, Ref. 18, section 3.2.1).
ACCEPTABLE DAILY INTAKES (ADI) FOR MAN OF SOME EMULSIFIERS AND
STABILIZERS
Substancea ADI
(mg/kg body weight)
Carrageenan )
)
Furcellaran ) 0 - 5003
Arabic gum No limit2
Carob bean gum No ADI
Guar gum 0 - 1251
Karaya gum No ADI
Tragacanth gum No ADI
Polyglycerol esters of
interesterified ricinoleic acid 0 - 3.751
Propylene glycol esters of fatty acids 0 - 204
Stearoyl lactylate, Calcium saltc )
)
Stearoyl lactylate, Sodium saltc ) 0 - 2.51
Stearyl citrate 0 - 1.251
Sucrose esters of fatty acidsb 0 - 2.51
Hydroxylated lecithinc No ADI
Ammonium salts of phosphatidic acidsc 0 - 151
Hydroxypropyl cellulose 0 - 305,6
Pectin No limit2
Propylene glycol alginate 0 - 12.51
a Specifications will be published for these compounds (see
Annex 1, Ref. 19).
b Containing not more than 50 ppm of dimethylformamide.
c Tentative specification.
1 Temporary acceptable daily intakes - details on further
information required are given in the respective monographs.
2 Not limited except by good manufacturing practice.
3 As carrageenan or furcellaran, or the sum of both.
4 As propylene glycol.
5 As any of the acceptable cellulose derivatives or any
combination of them (see Annex 1, Ref. 13).
6 Higher levels for dietetic or calorie control purposes.
Note: No specifications or monographs were prepared for mono- and
diglycerides of fatty acids esterified with acetylcitric acid,
more- and diglycerides of fatty acids esterified with phosphoric
acid and monoglyceride citrate, because of lack of information (see
Annex 1, Ref. 18, section 3.2.3). For the monograph on propylene
glycol esters of fatty acids, see Annex 1, Ref. 12.
ACCEPTABLE DAILY INTAKES (ADI) FOR MAN OF SOME ANTI-CAKING AGENTS
Substancea ADI
(mg/kg body weight)
Ferrocyanide, calcium )
)
Ferrocyanide, potassium ) 0 - 0.001251
)
Ferrocyanide, sodium )
Phosphate, calcium, tribasic )
)
Phosphatep magnesium, tribasic ) 0 - 303
Salts of Myristic, palmitic and
stearic acid with bases accepted
for food use No limit2
Silicon Dioxide, Amorphous (includes )
silica aerogel; hydrated silica; )
silicic acid; dehydrated silica gel) )
)
Aluminium silicate (includes Kaolin) )
)
Calcium silicate ) No limit2
)
Magnesium silicate (includes Talc, )
Magnesium trisilicate) )
)
Sodium Alumino silicate )
a Specifications will be published for these compounds (see
Annex 1, Ref. 19).
1 Temporary acceptable daily intakes - details on further
information required are given in the respective monograph.
2 Not limited, except by good manufacturing practice,
3 As total dietary phosphorus intakes from both food and food
additives (see Annex 1, Ref. 7).
Note: Other anti-caking agents were considered by the Expert
Committee, but no monographs were prepared (see Annex 1, Ref. 18,
section 3.3).
ACCEPTABLE DAILY INTAKES (ADI) FOR MAN OF CERTAIN OTHER FOOD
ADDITIVES
Substancea ADI
(mg/kg body weight)
Monosodium glutamateb Decision postponed
Calcium sulfate No limit2
Potassium choratec Not to be used
Ascorbyl palmitated 0 - 1.253
Ascorbyl stearate 0 - 1.253
Dimethylpolysiloxanee 0 - 0.251
Oxystearin 0 - 25
NDGAd No ADI
a Specifications will be published for these compounds (see
Annex 1, Ref. 19
b Tentative specifications.
c Identification tests only.
d Specifications are available for these compounds (see
Annex 1, Ref. 3).
e As dimethylpolysiloxane fluid with or without added
silicon dioxide.
1 Temporary acceptable daily intakes - details on further
information required are given in the respective monographs.
2 Not limited, except by good manufacturing practice.
3 As ascorbyl palmitate or stearate or the sum of both.
Note: No monographs were prepared for certain substances (see Annex
1, Ref. 18, section 3.4). However, a tentative specification was
prepared for isoamyl gallate and identification tests for ethyl
protocatechuate.