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
National assessments of intake of iron oxides
Conclusions and recommendations
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
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.
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
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.
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.