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)