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Application A570 – Ferric Sodium Edetate as a Permitted form of Iron – Draft Assessment Report

4 February 2008

Dear Sir/Madam

Thank you for the opportunity to comment on this application. The New Zealand Food Safety Authority (NZFSA) has the following comments to make.

NZFSA agrees with the preferred approach Option 2 to amend Standard 1.1.1 to include ferric sodium edetate (EDTA) as a permitted form of iron where iron is currently permitted in the Food Standards Code, with the exception of ‘breakfast cereals, as purchased’ and ‘formulated supplementary foods for young children’.

NZFSA agrees that exempting ‘breakfast cereals, as purchased’ and ‘formulated supplementary foods for young children’ is appropriate to minimise the risk of high intakes of EDTA as demonstrated in the dietary assessment.

Safety Assessment

NZFSA is satisfied with the JECFA evaluation that ferric sodium EDTA is suitable to use as a source of iron for food fortification, provided that total intake of iron from all sources including contaminants does not exceed the provisional maximum tolerable daily intake of 0.8mg/kg body weight (bw) and that total intake of EDTA compounds (including ferric sodium EDTA) does not exceed the ADI of 0-2.5mg/kg bw or up to 1.9mg/kg bw.

Dietary Assessment

NZFSA recognises that Scenario 2 (based on market share) for dietary modelling is the most likely of the two scenarios. However, Scenario 1 (based on replacement) does highlight that if all permitted foods were replaced with ferric sodium EDTA the ADI (for EDTA) would be exceeded. Therefore, NZFSA recommends that if ferric sodium EDTA is permitted as a form of iron, EDTA exposure will need to be monitored through a fortification monitoring programme to ensure that industry uptake of the new form is not underestimated and intakes of EDTA do not exceed the ADI.

NZFSA recommends that FSANZ not only consider the impact on dietary intake of EDTA through exempting ‘breakfast cereals, as purchased’ and ‘formulated supplementary foods for young children’, but the benefit of also exempting breads (and/or cereal flours, as these are used to make bread products) from the list of foods permitted to contain iron. Key results of the 1997 New Zealand National Nutrition Survey indicate that bread is the greatest single source of iron for females 15 years and over (13%), and bread is a large source of iron (second to beef and veal) for males 15 years and over. Furthermore, results of the 2002 Children’s Nutrition Survey indicate that bread provides 12% of the total iron to the diets of 5-14 year old children, second to that of breakfast cereals (18%). These figures highlight the importance of bread in the diet of New Zealanders. If the consumption patterns of Australian children are similar to that of New Zealand children (as indicated in the dietary modelling assessment), excluding ferric sodium EDTA from bread may minimise the risk of EDTA exceeding the ADI.

NZFSA also recommends that FSANZ considers the impact of setting a maximum permitted level for ferric sodium EDTA in those products that are permitted to contain iron (excluding ‘breakfast cereals, as purchased’ and ‘formulated supplementary foods for young children’). If the consumption patterns of Australian children are similar to that of New Zealand children (as indicated in the dietary modelling assessment), setting a maximum permitted level may minimise the risk of EDTA exceeding the ADI and reduce the impact of the increased bioavailability from ferric sodium EDTA.

Food manufacturers

NZFSA foresees that manufacturers may choose to substitute ferric sodium EDTA with the permitted form of iron currently in their fortified products and introduce new products due to the technologically enhancing properties stated in the DAR (increased stability, reduced rancidity, longer shelf life and improved colour and taste of foods). Any such increase in use of iron fortification strengthens the need for a monitoring programme to be in place, as mentioned in the DAR.

Labelling requirements

NZFSA considers that those clinically diagnosed with haemochromatosis are provided with adequate information on the presence of iron in a product by reading the ingredient listing on the product label (as regulated by Standard 1.2.4 Labelling of Ingredients), regardless of whether some forms of iron are more bio-available than others. It is agreed that due to the down regulation that occurs with iron in the body, the generally healthy population will not be at risk of iron toxicity.

Yours sincerely