Scientific Opinion on the safety and efficacy of alicyclic and aromatic lactones (chemical group 11) when used as flavourings for all animal species

Abstract

The flavour compounds 3-propylidenephthalide, 3-butylidenephthalide and 3,4-dihydrocoumarin belong to chemical group 11, defined as “alicyclic and aromatic lactones”. All three additives are currently authorised for use as flavours in food. The FEEDAP Panel was unable to perform an assessment of 3-butylidenephtalide because of the absence of data on the purity of the compound. The proposed use of 1 to 5 mg 3,4-dihydrocoumarin/kg complete feed was considered safe for all animal species with a margin of safety in the range from 5 to 18 fold. For 3-propylidenephthalide, the maximum safe level in feed would allow a use level of 1 mg/kg complete feed for all species with a margin of safety ranging from 1 to 2.5. Safe concentrations should be appropriately reduced if used in water for drinking. The narrow margin of safety would not allow the simultaneous administration of 3-propylidenephthalide in feed and water for drinking. No safety concern would arise for the consumer from the use of 3-propylidenephthalide and 3,4-dihydrocoumarin in animal nutrition. The material safety data sheets provided by the suppliers identified both compounds as irritant to skin, eye and the respiratory tract and harmful if swallowed. In addition 3,4-dihydrocoumarin has been shown to be a skin sensitizer. Based on QSAR modelling, 3,4-dihydrocoumarin and 3-propylidenephthalide at a dose of 5 and 1 mg/kg complete feed, respectively, are not expected to pose a risk to the environment. Since 3-propylidenephthalide and 3,4-dihydrocoumarin are used in food as flavourings, and their function in feed is essentially the same as that in food no further demonstration of efficacy was considered necessary.