The Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) has been asked 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 to prevent from microbiological and other contaminations. This type of packaging is common for baby foods. The estimated exposure of infants aged 6-12 months to ESBO migrating into baby foods from such packaging can sometimes exceed the Tolerable Daily Intake (TDI) by up to 4- to 5-fold. According to the Panel since there is an inbuilt safety factor of more than 100 in the derivation of the TDI, exceeding it by 4- to 5-fold does not imply that there will be adverse health effects in infants and ESBO is neither carcinogenic nor genotoxic. However, such a situation is undesirable and the Panel recommends to develop a specific migration limit for ESBO in baby foods applicable to babies fed mainly or exclusively on processed baby foods. The Panel notes also that up to 5% of the fatty acids in ESBO in gaskets may be converted into derivatives of ESBO such as chlorohydrins as the PVC is heated to high temperatures. Their concentration in food could achieve about 5% that observed for ESBO itself. 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.
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