Scientific Opinion on the safety and efficacy of propenylhydroxybenzenes (chemical group 17) when used as flavourings for all animal species

Abstract

Isoeugenol is a flavouring compound belonging to chemical group 17, defined as ‘propenylhydroxybenzenes’. The additive is currently authorised for use as flavour in food and is naturally found in various herbs and plants. The use of isoeugenol as a flavour in feed for fish and other aquatic species is contra‐indicated. The range of use levels of 1 to 5 mg/kg feed proposed by the applicant for isoeugenol is safe for all animal species (except fish) with a margin of safety in the range of 1 to 4. Considering the low margin of safety, the simultaneous administration of isoeugenol in feed and water for drinking for poultry should be avoided. The use of isoeugenol as flavour in non‐dairy mammals up to the highest use levels proposed in feed is safe for the consumer. However, the lack of data on metabolism and residues in all other species and categories precludes an assessment of consumer exposure from these sources. No data on the safety for the user was provided. Based on the information available in the literature, the FEEDAP Panel considered isoeugenol as an irritant to the respiratory system, skin and eyes, and as a skin and respiratory sensitiser. The use of the additive in animal nutrition at the levels proposed is expected to be safe for the environment. Since isoeugenol is used in food as flavouring, and its function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

Safety and efficacy of a feed additive consisting of an essential oil derived from the aerial parts of Cymbopogon flexuosus (Nees ex Steud.) Will. Watson (lemongrass oil) for use in all animal species (FEFANA asbl)

“…Toxicological data of subchronic studies, from which NOAEL values could be derived, were available for acetaldehyde [05.001] the representative compound in CG 1 (EFSA FEEDAP Panel, 2013 ), citral [05.020] the representative compound in CG 3 (EFSA FEEDAP Panel, 2016a ), citronellol [02.011], hex‐3(cis)‐en‐1‐ol [02.056] and 2,6‐dimethylhept‐5‐enal [05.074] in CG 4 (EFSA FEEDAP Panel, 2016b ), for heptan‐2‐one [07.002] and 6‐methylhept‐5‐en‐2‐one [07.015] in CG 5 (EFSA FEEDAP Panel, 2015a ), terpineol [02.230] 28 and linalool [02.013] in CG 6 (EFSA FEEDAP Panel, 2012a ), menthol [02.015] in CG 8 (EFSA FEEDAP Panel, 2016c ), isoeugenol [04.004] in CG 17 (EFSA FEEDAP Panel, 2012d ), myrcene [01.008], d‐limonene [01.045], p‐cymene [01.002] and β‐caryophyllene in CG 31 (EFSA FEEDAP, 2015b , 2016d ), and β‐caryophyllene epoxide [16.043] for CG 32 (EFSA CEF Panel, 2014 ). For d‐carvone [01.146] and 2‐pentylfuran [13.059], not present in the essential oil but structurally related to some components, the applicant made reference to a BMD lower confidence limit for a benchmark response of 10% (BMDL 10 ) of 60 mg/kg bw per day (EFSA SC, 2014 ; EFSA FEEDAP Panel, 2016c ) and of 8.52 mg/kg bw per day (EFSA FAF Panel, 2021a , b ), respectively.…”

“…According to Regulation (EC) 1565/2000, flavourings evaluated by JECFA before 2000 are not required to be re‐evaluated by EFSA. (b) EFSA evaluated isoeugenol [04.004], a mixture of (E)‐ and (Z)‐ isomers (EFSA FEEDAP Panel, 2012d ). (c) JECFA and EFSA evaluated d‐limonene [01.045] (EFSA, 2008b ).…”

“… (b) EFSA evaluated isoeugenol [04.004], a mixture of (E)‐ and (Z)‐ isomers (EFSA FEEDAP Panel, 2012d ). …”