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    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.
    





















    See Also:
       Toxicological Abbreviations