Safety of 31 flavouring compounds belonging to different chemical groups when used as feed additives for all animal species

Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of 31 compounds belonging to different chemical groups, when used as sensory additives in feed for all animal species. Twenty‐two out of the 31 compounds were tested in tolerance studies in chickens for fattening, piglets and cattle for fattening. For the remaining nine compounds, read across from structurally similar compounds was proposed. No adverse effects were observed in the tolerance studies at 10‐fold the intended level. The FEEDAP Panel concluded that the 22 compounds are safe for these species at the proposed use level and conclusions were extrapolated to all animal species for all the compounds except for α‐damascone [07.134]. In the absence of data that would allow the FEEDAP Panel to rule out the genotoxicity concern, the FEEDAP Panel cannot extend the conclusions for α‐damascone [07.134] to all animal species and cannot conclude on the safety for the consumer, the user and the environment. No safety concern would arise for the consumer from the use of the remaining 30 compounds up to the highest levels considered safe for target animals. The revised maximum safe levels for the 30 compounds are not expected to further impact on the previous conclusions on user safety. The concentrations considered safe for the target species are unlikely to have detrimental effects on the environment for all the compounds except β‐damascone [07.083] and (E)‐β‐damascone [07.224], for which in the absence of ecotoxicity data, the FEEDAP Panel cannot conclude on the safety for the terrestrial compartments. For the marine environment, the safe use level for 2‐methyl‐1‐phenylpropan‐2‐ol [02.035], α‐irone [07.011], β‐damascone [07.083] and (E)‐β‐damascone [07.224], phenethyl isovalerate [09.466], 4‐(p‐hydroxyphenyl) butan‐2‐one [07.055] and 2‐isopropyl‐4‐methylthiazole [15.026] is confirmed to be 0.05 mg/kg.

Safety and efficacy of a feed additive consisting of an essential oil obtained from the fruit of Coriandrum sativum L. (coriander oil) (FEFANA asbl)

“…25 The list of the compounds already evaluated by the EFSA Panels is given in Table 1 (see Section 1.2 ). Subsequently, linalool was considered safe at 30 mg/kg complete feed for all animal species based on the results of tolerance studies with a mixture of flavourings referred to as ‘TuttiFrutti mixture’ in chickens for fattening, piglets and cattle for fattening (EFSA FEEDAP Panel, 2020 ).…”

“…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. Linalool and camphor, which were included in tolerance studies with mixtures of flavourings ‘TuttiFrutti’ and ‘Herbal mixture’ (EFSA FEEDAP Panel, 2020 , 2023 ) are assessed separately.…”

“…The applicant included the two compounds, linalool and camphor, in tolerance studies with mixtures of flavourings (‘TuttiFrutti mixture’ and ‘Herbal mixture’) to demonstrate their safe use at higher levels than those currently evaluated as safe in feed (EFSA FEEDAP Panel, 2020 , 2023 ).…”

Safety of feed additives consisting of β‐damascone [07.083] and (E)‐β‐damascone [07.224] belonging to chemical group 8 for use in all animal species (FEFANA asbl)

“…Concentrations of β‐damascone [07.083] in manure samples collected during the tolerance trials 11 were provided to refine the calculations for PEC soil . However, in the absence of an ecotoxicity study on earthworms, from which a predicted no effect concentration (PNEC) estimate for the terrestrial compartment could be derived, the FEEDAP Panel could not reach a conclusion on the safety of β‐damascone [07.083] and (E)‐β‐damascone [07.224] for the terrestrial compartment (EFSA FEEDAP Panel, 2020 ).…”

“…The EFSA FEEDAP Panel issued two opinions on the safety and efficacy of b-damascone [07.083] and (E)-b-damascone [07.224] when used in feed for all animal species (EFSA FEEDAP Panel, 2016, 2020. In both assessments, the FEEDAP Panel could not reach a conclusion on the safety of b-damascone [07.083] and (E)-b-damascone [07.224] for the terrestrial compartment in the absence of ecotoxicity data.…”