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    INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    WORLD HEALTH ORGANIZATION





    SAFETY EVALUATION OF CERTAIN FOOD
    ADDITIVES AND CONTAMINANTS



    WHO FOOD ADDITIVES SERIES: 44





    Prepared by the Fifty-third meeting of the Joint FAO/WHO
    Expert Committee on Food Additives (JECFA)





    World Health Organization, Geneva, 2000
    IPCS - International Programme on Chemical Safety

    EVALUATION OF NATIONAL ASSESSMENTS OF INTAKE OF IRON OXIDES

    First draft prepared by Chen Junshi

    Institute of Nutrition and Food Hygiene, Chinese Academy of Preventive
    Medicine, Beijing, China

    Introduction
    National assessments of intake of iron oxides
         Australia
         Canada
         United Kingdom
         United States
    Conclusions and recommendations
    Bibliography

    1.  INTRODUCTION

         The Committee assessed estimates of national intake of iron
    oxides when used as a colouring agent in food additives. Use of iron
    oxides is permitted in most countries, but the data submitted suggest
    that the actual use by the food industry is very limited. Data on
    intake were submitted by four countries, Australia, Canada, the United
    Kingdom, and the United States. The Committee evaluated iron oxides at
    its eighteenth, twenty-second, and twenty-third meetings (Annex 1,
    references 35, 47, and 50) and established an ADI of 0-0.5 mg/kg bw
    at its twenty-third meeting.

    2.  NATIONAL ASSESSMENTS OF INTAKE OF IRON OXIDES

    2.1  Australia

         As Australia does not currently allow the use of iron oxides, no
    national regulatory use levels were available on which to base an
    assessment of intake. The submitted assessment was conducted on the
    basis of the levels proposed in the draft General Standard for Food
    Additives (GSFA) being established by the Codex Committee on Food
    Additives and Contaminants in combination with national data on food
    consumption for 1995. It was assumed in the calculation that all foods
    in a category contain iron oxides at the maximum level proposed.
    Further, when use in a food category is restricted only by good
    manufacturing practice, the model assumes a zero concentration in that
    food. The mean body weight of the respondents was 67 kg.

         The estimated mean intake of iron oxides in Australia was 0.37
    mg/kg bw per day (75% of the ADI) for all 13 858 respondents. For
    consumers only, the mean intake was 0.78 mg/kg bw per day (160% of the
    ADI), the median was 0.29 mg/kg bw per day (59% of the ADI), and the
    intake of 95th percentile consumers was 3.13 mg/kg bw per day (620% of
    the ADI). In view of the conservative assumptions made in this
    estimate, it is unlikely that the long-term intake of iron oxides
    would exceed the ADI.

    2.2  Canada

         Examination of inspection reports and a review by the food
    industry of the use of colours, conducted during the 1970s, revealed
    that there was little use of iron oxides as a colouring agent. In
    1996, however, iron oxides were listed for use in edible collagen film
    used on hams, and the mean intake of iron oxides (expressed as iron)
    due to this use was estimated to be 0.0008 mg/kg bw per day for all
    persons, with a mean intake for 'eaters only' of 0.07 mg/kg bw per
    day. It is unlikely that long-term intake of iron oxides would exceed
    the ADI.

    2.3  United Kingdom

         The use of iron oxides as a food colour in the United Kingdom is
    permitted in many foods at levels concordant with good manufacturing
    practice, except in those listed in schedules 2 and 3 of The Colours
    in Food Regulations 1995.

         Iron oxides and hydroxides were found in 22 food products in the
    United Kingdom, but its use was so low that the estimated dietary
    intake from poundage data was 0 mg/kg bw per day. It was concluded
    that the intake of iron oxides would not exceed the ADI.

    2.4  United States

         Iron oxides are permitted for use at a level of 0.1% by weight in
    sausage casings on the basis of the weight of the finished sausage
    product. No data on the uses of iron oxides in food were reported by
    the industry to the National Academy of Sciences in 1987, and the
    industry has not reported any recent use of iron oxides in foods.

         An estimate of intake of iron oxides was submitted which was
    based on food intake from a three-day national survey of food
    consumption in 1989-92, combined with maximum regulatory limits. It
    was assumed that all foods that could be coloured by iron oxides would
    contain it. The mean estimated intake of iron oxides by 11 912
    respondents was 0.08 mg/kg bw per day (16% of the ADI), while the 90th
    percentile intake was estimated to be 0.28 mg/kg bw per day (56% of
    the ADI). For 2144 'eaters only', the mean intake was 0.45 mg/kg bw
    per day (90% of the ADI), and the 90th percentile intake was 0.89
    mg/kg bw per day (180% of the ADI).

         It was concluded that it is unlikely that the intake of iron
    oxide would exceed the ADI on a long-term basis because iron oxides
    would be not be used in all sausages at the maximium permitted level.
    Futhermore, the industry has not reported any recent use of iron
    oxides in food.

    3.  CONCLUSIONS AND RECOMMENDATIONS

         Iron oxides are permitted for use in foods in the draft General
    Standard for Food Additives being established by the Codex Committee
    on Food Additives and Contaminants, the use being limited only by good
    manufacturing practice. The Committee assessed national estimates of
    intake of iron oxides used as additives for colouring food. Use of
    iron oxides is permitted in most countries. Data were submitted by
    four countries: Australia, Canada, the United Kingdom, and the USA.

         Current use of iron oxides as a food colour is very limited, and
    the intakes based on national standards do not exceed the ADI. The
    Committee concluded that it is unlikely that the intake of iron oxides
    will exceed the ADI. 

    4.  BIBLIOGRAPHY

    Baines, J. (1999) Data sheets for Australia for iron oxides. Personal
    communication from the Australia New Zealand Food Authority, Canberra,
    to J. Paakkanen, FAO, 12 January 1999.

    Fisher, C. (1998) Dietary exposure to the four additives referred to
    JECFA by CCFAC. Personal communication from the Joint Food Safety and
    Standards Group, London, to J. Paakkanen, FAO, 22 December 1998.

    Rulis, A.M. (1998) United States intake data on annato extracts,
    canthaxanthin, erythrosine and iron oxides. Personal communication
    from the Food & Drug Administration, Washington DC, to J. Paakkanen,
    FAO, 30 November 1998.

    Scalzo, S. (1998) Dietary intake data on iron oxides. Personal
    communication from the Food Directorate, Ottawa, to J. Paakkanen, FAO,
    29 November 1998.
    


    See Also:
       Toxicological Abbreviations
       IRON OXIDES (JECFA Evaluation)