Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to di-Butylphthalate (DBP) for use in food contact materials

Abstract

SUMMARYThe Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) has been asked to re-evaluate di-butylphthalate (DBP) for use in the manufacture of food contact materials.Previously, a temporary Tolerable Daily Intake (t-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 DBP relate to reproduction. From the several studies available, the critical observations were as follows.In a two-generation reproduction study in rats with a continuous breeding protocol and with exposure of both male and female animals, the lowest dose-level of 0.1 % in the diet (52 mg/kg bw/day for males and 80 mg/kg bw/day for females) appeared to be a Lowest Observed Adverse Effect Level (LOAEL), based on embryotoxic effects on pup weight and number of live pups per litter. These effects were seen in the absence of maternal toxicity. It should be noted that the LOAEL of 52 mg/ kg bw/day (0.1% in the diet) was derived from an extensive study utilising sensitive endpoints (such as sperm parameters, oestrous cycle characterization and detailed testicular histopathology).In another reproduction study, a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw/day and a LOAEL of 100 mg/kg bw/day for toxicity of DBP on male reproductive development in the F1 generation have been observed.A recent developmental toxicity study in the rat, with dietary exposure to DBP during the period from late gestation (gestational day 15) to the end of lactation (postnatal day 21), has shown effects on the development of male and female offspring at lower doses than those found previously. Based on loss of germ cell development and mammary gland change at 20 mg/kg in the diet (the lowest tested dose), a NOAEL could not be established. However, given the reversibility of the effects at all dose levels and especially at the lowest dose level (20 mg/kg feed, which corresponds to 1.5 to 3 mg/kg bw/day) and also given that in several reproductive toxicity studies with longer exposure periods approximately 30 -fold higher NOAELs or LOAELs have been determined, an uncertainty factor of 200, to derive a TDI for DBP based on the LOAEL of 20 mg/kg feed is considered sufficient. The limited available data on DBP concentration in foods and diets in the UK and Denmark were used to provide an estimation of dietary exposure. In the UK, mean and high (97.5th percentile) intakes of DBP from dietary sources were estimated to be respectively 0.013 and 0.031 mg/person/day in the adult population (equivalent to 0.2 and 0.5 µg/kg bw/day) considering a 60 kg adult. In a Danish study, DBP estimated mean exposure ranged from 0.13 to 0.29 mg/day, i.e. 1.8 to 4.1 µg/kg bw/day, considering a 70 kg adult. Based on the highest concentration of DBP determined, exposure at high percentiles was estimated as...

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