Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on a request from the Commission on the application of A Total Reduction Factor of 5 for di(2-ethylhexyl)adipate used as plasticiser in flexible PVC food packaging films (Question No EFSA-Q-2003-071) Adopted on 27 April 2005

The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food has been asked by the Commission whether or not, for the substance di(2-ethylhexyl) adipate (DEHA) used as plasticiser in flexible PVC films, a Total Reduction Factor (TRF) of 5 could be used for all food packaging applications. The current procedure for estimating consumer exposure to substances migrating from food contact materials into food assumes a person consumes 1 kg of packaged food daily. However, in the case of fat, it has been demonstrated that the total daily fat consumption by European adults does not exceed 200 g. To take account of this, migration values into fatty foods are corrected by a Fat (Consumption) Reduction Factor (FRF), variable from 1 to 5. Migration of substances from food contact materials into fatty foods can be estimated using the fat simulant, olive oil. Olive oil is known to extract higher quantities of migrants than do many fatty foods themselves. To take account of this, migrant values obtained using olive oil (Simulant D) are corrected by applying a reduction factor, known as the DRF, variable from 1 to 5. The Total Reduction Factor (TRF) is obtained by multiplying the DRF by the FRF and with the restriction that its value should not be higher than 5. The Panel concluded that the studies presented of migration from plasticized PVC films, provided too limited a basis to demonstrate that a Total Reduction Factor (TRF) of 5 could be used for DEHA in all food packaging applications. The general applicable reduction factors (DRF) set in Directive 85/572/EEC for fish, meat and poultry are currently 3 and 4. The Panel concluded, however, that in the special cases presented, for fresh meat, poultry and fish with less than 20% fat and intended to be overwrapped on trays using plasticised PVC films and then stored for up to four days under refrigerated conditions, followed by 4 h at 25 degrees C, application of a simulant D reduction factor of 5 could be justified, provided the migration with simulant D is determined after a contact period of 10 days at 20 degrees C.