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 Butylbenzylphthalate (BBP) for use in food contact materials Question N degrees EFSA-Q-2003-190 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 butylbenzylphthalate (BBP) for use in the manufacture of food contact materials. Previously, a temporary Tolerable Daily Intake (t-TDI) of 0.1 mg/kg bw was set by the Scientific Committee for Food (SCF) based on the end-point 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 BBP relate to reproduction. From the different studies available, the critical observations were as follows. Decreases in epididymal spermatozoal concentrations have been reported at dose levels of 200 mg/kg bw/day and 2200 mg/kg bw/day, with a No Observed Adverse Effect Level (NOAEL) of 20 mg/kg bw/day and a Lowest Observed Adverse Effect Level (LOAEL) of 200 mg/kg bw/day. However, accompanying histopathological effects on the testes and adverse impact on fertility were only seen at 2200 mg/kg bw/day. A NOAEL of 20 mg/kg bw/day and a LOAEL of 100 mg/kg bw/day were reported from a two-generation study, based on increased serum follicle stimulating hormone (FSH) concentrations in the F-0 parental males. Furthermore, in the same study all other examined end-points had a NOAEL of 100 mg/kg bw/day. In another developmental toxicity study in the rat using a multiple dose design, foetotoxicity effects were observed. The overall benchmark dose, based on a 1% increase in abnormal testis location, was assessed at 95 mg/kg bw/day. A multi-generation study including the F2 generation had an overall NOAEL of 50 mg/kg bw/day, based on the reduction in anogenital distance in F1 and F2 offspring at 250 mg/kg bw/day. Based on the current literature on BBP testicular toxicity, the Panel allocated a Tolerable Daily Intake (TDI) of 0.5 mg/kg bw, derived from a NOAEL of 50 mg/kg bw/day found in a multi-generation study and making use of an uncertainty factor of 100. The limited available data on BBP concentration in foods and diets in UK and Denmark were used to provide an estimation of the dietary exposure. In the UK, mean and high (97.5 percentile) intakes of BBP from dietary sources were estimated to be respectively 0.008 and 0.020 mg/person/day in the adult population (equivalent to 0.1 and 0.3 mu g/kg bw/day). In a Danish study, estimated mean exposure ranged from 0.02 to 0.03 mg/day, i.e. 0.3 to 0.4 mu g/kg bw/day considering a 70 kg adult. Based on the highest concentration of BBP determined, exposure at high percentiles was estimated as 0.32 mg/day equivalent to 4.5 mu g/kg bw/day.