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 Di-isodecylphthalate (DIDP) for use in food contact materials Question N degrees EFSA-Q-2003-195 Adopted on 30 July 2005

The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) has been asked to re-evaluate di-isodecylphthalate for use in the manufacture of food contact materials. There are two different di "isodecyl" phthalate products with different CAS numbers (68515-49-1 and 26761-40-0). According to the European Council for Plasticisers and Intermediates (ECPI) these two products are prepared essentially from the same starting materials, through an identical olefin oligomerisation process and through similar oxo alcohol manufacturing and phthalate esterification processes. The two phthalates are considered fully interchangeable within their whole range of the market end uses. Therefore, in this document they are considered together. Previously, a group Tolerable Daily Intake (g-TDI) of 0.15 mg/kg bw (with di-isononylphthalate (DINP)) 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 usual critical effects of phthalates relate to liver, testicular and reproduction toxicities. From the several studies available on DIDP, the critical observations were as follows: There is no indication of effects on reproductive organs from histological observation in repeated dose toxicity studies. In a recent two-generation study in rats, the F2 offspring survival was decreased. Based on this effect, a no observed adverse effect level (NOAEL) of 33 mg/kg bw/day could be established. In a 13-week oral study in dogs, liver changes were seen at higher dose levels with a lowest observed adverse effect level (LOAEL) of 77 mg/kg bw/day and 88 mg/kg bw/day for male and female dogs respectively. The Panel concluded that the NOAEL of 15 mg/kg bw/day from this study should be used in the risk assessment. Based on the liver effects in dogs (a species considered as a non-sensitive species to peroxisome proliferation) with a NOAEL of 15 mg/kg bw/day, and on a decrease of F2 offspring survival with a NOAEL of 33 mg/kg bw/day, a lowest overall NOAEL of 15 mg/kg bw/day has been considered. Making use of this NOAEL and of an uncertainty factor of 100, a TDI of 0.15 mg/kg bw is derived. The limited data available on DIDP concentration in foods and diets in UK (1996, 1998) and Denmark (2003) were used to provide an estimation of the dietary exposure. In the UK, potential exposure to DIDP from dietary sources was based on the method detection limit and estimated to be less than 0.17 mu g/kg bw/day. For newborns (0-6 months) and for infants (>6 months), the potential exposure to DIDP derived from infant formulae consumption corresponded to 2.4 mu g/kg bw/day and 1.8 mu g/kg bw/day respectively. A Danish DIDP total oral exposure was reported recently and was estimated to be 3 mu g/kg bw/day for adults. Higher values for total oral exposure (210, 53 and 7 mu g/kg bw/day) were reported for infants (6-12 months), children (1-6 years) and children (7-14 years), respectively. However the two highest values for young children, derived mainly from the contribution of the estimated oral exposure related to toys that is included in the above values. DIDP use in toys is provisionally banned in the EU since 1999. Furthermore, the computer modeling program (EUSES) which was used for these intake estimates is a conservative one and the obtained values are not representative of the possible exposure via food contact materials. However, the value of 7 mu g/kg bw/day from this study has been taken as a worst case estimate of dietary exposure to DIDP. The Panel noted that the above estimated exposure via the diet of around 7 mu g/kg bw/day is well below the TDI. However, there are some indications that DIDP levels in food may be increasing in recent years, and so, more up-to-date estimations of exposure from the diet are desirable. The Panel noted also that DIDP and DINP (phthalic acid, diester with primary saturated C8-C10 branched alcohols, C9 rich, CAS n degrees 28553-12-0 and 68515-48-0, PM/REF 75100) are mixtures that overlap chemically with each other and cannot analytically be distinguished clearly if present in a mixture. For this reason, it is proposed that for DINP and DIDP a group restriction is established for migration from food contact materials.