SUMMARYThe Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) has been asked to evaluate the results of the studies available on the migration of epoxidised soybean oil (ESBO) and ESBO-derivatives from containers of baby foods and to give an opinion on the risk for infants and, as regards the ESBO-derivatives, for the consumer in general. ESBO is used as a plasticiser and stabiliser in polyvinyl chloride (PVC) gaskets of metal lids used to seal glass jars and bottles. The gasket forms an airtight seal preventing microbiological and other contaminations. This type of packaging is common for baby foods packed in glass jars and bottles.The evaluation was conducted in the context of the current uses of ESBO in food packaging, with an emphasis on assessment of migration into baby foods that might result in intakes of ESBO close to or exceeding the Tolerable Daily Intake (TDI) of 1 mg/kg body weight. In addition, the evaluation considered the formation of derivatives of ESBO such as chlorohydrins, which may occur as the PVC is heated to high temperatures.The TDI of 1 mg/kg body weight is based on a no-effect level of 140 mg/kg body weight/day for organ weight changes observed in a 2-year rat study. The estimated exposure of infants aged 6-12 months to ESBO migrating into baby foods packaged in glass jars and bottles with metal lids sealed with PVC gaskets can sometimes exceed the TDI by up to 4-to 5-fold. Since there is an inbuilt safety factor of more than 100 in the derivation of the TDI, exceeding the TDI by 4-to 5-fold does not imply that there will be adverse health effects in infants. Moreover, the Panel notes that ESBO is neither carcinogenic nor genotoxic. However, such a situation is undesirable because it could reduce on a regular basis the safety margin between exposure and adverse effects.It is therefore recommended to develop a specific migration limit for ESBO in baby foods, derived from the TDI of 1 mg/kg body weight and taking into consideration the amounts which might be eaten on a daily basis by an infant of 6 months of age, weighing 7.5 kg, fed mainly or exclusively on processed baby foods.In the absence of adequate toxicological data on ESBO derivatives, no advice can yet be given on the significance for health of such derivatives in foods. The Panel notes that up to The EFSA Journal (2004)64 2 5% of the fatty acids in ESBO in gaskets is converted into derivatives. These derivatives are expected to migrate at the same rate as ESBO and so their concentration in food could achieve about 5% that observed for ESBO itself.Further analytical and toxicological data on ESBO derivatives are needed and a programme should be established to that end.