Safety of 41 flavouring compounds providing a herbal flavour and belonging to different chemical groups for use as feed additives in all animal species (FEFANA asbl)

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 41 compounds to provide a Herbal flavour and belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fourteen out of the 41 compounds were tested in tolerance studies in chickens for fattening, piglets, cattle for fattening and Atlantic salmon. No adverse effects were observed in the tolerance studies at 10‐fold the intended level. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the 14 tested compounds were safe for these species at the proposed use level and conclusions were extrapolated to all animal species. For the remaining 27 compounds, read‐across from structurally similar compounds tested in tolerance trials and belonging to the same chemical group was applied. The FEEDAP Panel concluded that these 27 compounds were safe for all animal species at the proposed use level. No safety concern would arise for the consumer and the environment from the use of the 41 compounds up to the maximum proposed use level in feed.

Safety and efficacy of feed additives consisting of essential oils from the fruit and stems of Foeniculum vulgare Mill. ssp. vulgare: Bitter fennel oil for use in all animal species and sweet fennel oil for use in dogs and cats (FEFANA asbl)

“…Recently, d‐ camphor was assessed in tolerance studies with a mixture of flavourings referred to as ‘Herbal mixture’ in chickens for fattening, piglets, cattle for fattening and salmons. The tolerance studies showed that d‐ camphor was safe up to 5 mg/kg complete feed (EFSA FEEDAP Panel, 2023b ). The FEEDAP Panel considers that the conclusions reached for d‐ camphor can be extrapolated to d‐ fenchone, the mixture of isomers of camphor and that of fenchone by applying read‐across.…”

“…As the additive under assessment is a fully defined mixture (the identified components represent > 99% of the % GC area, see Section 3.2.1 ), the FEEDAP Panel applied a component‐based approach to assess the safety for target species of the essential oil. Camphor, which was included in tolerance studies with a mixture of flavourings ‘Herbal mixture’ (EFSA FEEDAP Panel, 2023b ), and the structurally‐related compounds (fenchone and fenchyl derivatives) are assessed separately. Estragole, a substance for which a concern for genotoxicity has been identified, is also assessed separately.…”

“…The applicant included camphor in tolerance studies with a mixture of flavourings (‘Herbal mixture’) to demonstrate its safe use at higher levels than those currently evaluated as safe in feed (EFSA FEEDAP Panel, 2023b ).…”

“…The applicant provided further evidence on the safety of camphor in the form of tolerance trials in chickens for fattening, piglets, cattle for fattening and salmons, which showed that d ‐camphor was safe up to 5 mg/kg complete feed (EFSA FEEDAP Panel, 2023b ). In the current assessment the applicant proposed to read‐across from d ‐camphor to its enantiomer and to d ‐fenchone and its enantiomer.…”

“…Based on the outcome of tolerance trials in chickens for fattening, piglets, cattle for fattening and salmons with d ‐camphor and by applying read‐across, the FEEDAP Panel concluded that a concentration of fenchone in feed of 5 mg/kg complete feed is considered safe for all animal species (EFSA FEEDAP Panel, 2023b ). Therefore, the levels of fenchone of 0.125 and 0.103 mg/kg complete feed resulting from the use of sweet fennel oil at the maximum proposed use level of 2.3 and 1.9 mg/kg complete feed for dogs and cats are considered safe.…”