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-isononylphthalate (DINP) for use in food contact materials Question N° EFSA-Q-2003-194 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-isononylphthalate for use in the manufacture of food contact materials. Di-isononylphthalate (DINP) is a mixture of esters of o-phthalic acid with C8-C10 (C9 rich) alkyl alcohols. These alcohols can be obtained by different processes, yielding different ratios of chain length and branching distribution, which result in different DINP types. Presently, there are 2 different DINP types being used (CAS 68515-48-0 and CAS 28553-12-0). These DINP mixtures have in common many of their constituents, and differ by isomeric distribution curves. Therefore, in this document they are considered together. Previously, a group Tolerable Daily Intake (g-TDI) of 0.15 mg/kg bw (with di-isodecylphthalate (DIDP)) 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 DINP, the critical observations were as follows. No overt toxicity was observed on reproductive organs in rats. No observed adverse effect levels (NOAEL) of 500 mg/kg bw/day and 622 mg/kg bw/day were established for minor developmental effects and decreases in live birth and survival indices, respectively. Maternal toxicity was limited to lower mean body weight and hepatic changes with a lowest observed adverse effect level (LOAEL) of 114 mg/kg bw/day. The pivotal toxicological effect for DINP is considered to be the hepatic changes seen in various studies. In a two-year chronic toxicity study in rats, there was an increased incidence of spongiosis hepatis, accompanied by increased serum levels of liver enzymes and increases in absolute and relative liver and kidney weights in both sexes. The Panel agreed to use the NOAEL of 15 mg/kg bw/day for non-peroxisomal proliferation-related chronic hepatic and renal effects in establishing a TDI. Making use of this NOAEL and of an uncertainty factor of 100, a TDI of 0.15 mg/kg bw is derived. The limited available data on DINP 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 DINP 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 DINP derived from infant formulae consumption corresponded to 2.4 mu g/kg bw/day and 1.8 mu g/kg bw/day, respectively. In Denmark, the total oral exposure was estimated to be 5 mu g/kg bw/day for adults. Higher values for total oral exposure (216, 63 and 10 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. DINP use in toys is provisionally banned in 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 10 mu g/kg bw/day from this study has been taken as a worst case estimate of dietary exposure to DINP. The Panel noted that the above estimated exposure via the diet of around 10 mu g/kg bw/ day is well below the TDI. However, there are some indications that DINP levels in food may be increasing in recent years, and so, more updated estimations of exposure from the diet are desirable. The Panel also noted that DINP and DIDP (phthalic acid, diester with primary saturated C9-C11 branched alcohols, C10 rich, CAS n degrees 26761-40-0 and 68515-49-1, REF No 75105) 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.