Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on a request from the Commission related to Bis(2-ethylhexyl)phthalate (DEHP) for use in food contact materials Question No EFSA-Q-2003-191 Adopted on 23 June 2005 by written procedure

The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) has been asked to re-evaluate bis(2-ethylhexyl)phthalate (DEHP) for use in the manufacture of food contact materials. Previously, a Tolerable Daily Intake (TDI) of 0.05 mg/kg bw was set by the Scientific Committee for Food (SCF), based on the endpoint of peroxisome proliferation in rodent liver. There is now a scientific consensus that liver peroxisome proliferation in rodents is not relevant for human risk assessment. The critical effects of DEHP relate to reproduction. From the several studies available, the critical observations were as follows. A recent well conducted 2-generation reproduction study of DEHP in rats has documented effects on reproductive performance and fertility in the F0 and F1 parental animals. Substance-induced signs of adverse developmental toxicity were noted in the progeny of the F0 and F1 parents from 340 mg/kg bw/day onwards. The No Observed Adverse Effect Level (NOAEL) for reproductive performance and fertility was 340 mg/kg bw/day and for developmental toxicity 113 mg/kg bw/day, respectively. A multigeneration reproductive assessment in which DEHP was administered to rats in the diet has also been recently performed. From this study, a NOAEL of 4.8 mg/kg bw/day for testicular toxicity and developmental toxicity can be derived. Based on the current literature on DEHP testicular toxicity, the Panel allocated a TDI of 0.05 mg/kg bw, based on a NOAEL of 5 mg/kg bw/day, and making use of an uncertainty factor of 100. The limited available data on DEHP concentration in foods and diets in UK and Denmark were used to provide an estimation of dietary exposure. In the UK, mean and high (97.5th percentile) intakes of DEHP from dietary sources were estimated to be respectively 0.15 and 0.3 mg/person/day in the adult population (equivalent to 2.5 and 5 mu g/kg bw/day) considering a 60 kg adult. In a Danish study, DEHP estimated mean exposure ranged from 0.19 to 0.3 mg/day, i.e. 2.7 to 4.3 mu g/kg bw/day, considering a 70 kg adult. Based on the highest concentration of DEHP determined, exposure at high percentiles was estimated as 1.1 mg/day equivalent to 15.7 mu g/kg bw/day. In another Danish study, the main dietary sources of exposure were estimated to be leaf crops (53%), root crops (13%), milk (12%) and fish (10%). The total daily oral intake at the regional level (Denmark) was estimated to be 4.5 mu g/kg bw/day in adults, 26 mu g/kg bw/day in children aged 1 to 6 years, and 11 mu g/kg bw/day in children aged 7 to 14 years. Based on the detection limit, intake from infant formulae would be less than 10 mu g/kg bw/day in infants of less than 6 months and 4 mu g/kg bw/day in infants of more than 6 months. For infants of more than 6 months, ready-to-use baby foods were also taken into account and the exposure was therefore estimated to be 23.5 mu g/kg bw/day. The Panel noted that exposure to DEHP from food consumption is in the range of the TDI. There are, however, a number of other sources which contribute to the overall human exposure to DEHP. The Panel recommends that improved estimates of exposure to DEHP from all sources along with their relative importance should be provided in order to decide what proportion of the TDI can be allocated to food contact materials alone.