Statement on the safety of iodized ethyl esters of poppy seed oil as a source of iodine added for nutritional purposes to foodstuffs

Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to
Food (ANS) was asked to deliver an opinion on the safety of “iodized ethyl esters of poppy seed oil” (ethyl
esters of iodinated fatty acids of poppy seed oil, EEIFAPSO) and the bioavailability of the iodine from this source
when used for the fortification of vegetable oils with iodine. The safety of iodine itself, in terms of amounts that
may be consumed, is outside the remit of this Panel. EEIFAPSO are described as a mixture of ethyl palmitate,
ethyl stearate, ethyl monoiodostearates, ethyl diiodostearates and ethyl triiodostearates. The iodine content of
EEIFAPSO is 37-39 % (w/w) and the source is intended to be added at the concentration of 2.76-3.05 mg of
EEIFAPSO per kg of vegetable oil. The Panel noted that kinetic data referring to exposure conditions of
fortification are limited and that available results are indicating that a possible bioaccumulation of EEIFAPSO
and/or their metabolites may occur. Furthermore the available data did not allow a quantitative assessment of the
bioavailability of iodine from EEIFAPSO. No data are available on short-term, subchronic and chronic toxicity,
carcinogenicity and reproductive toxicity of EEIFAPSO. Overall the Panel could not conclude on the safety of
EEIFAPSO as a source of iodine in food fortification and on the bioavailability of iodine from this source due to
data gaps in the kinetic and the dynamic properties of the different iodinated compounds in EEIFAPSO.