Safety and efficacy of a feed additive consisting of an essential oil from the flowers of Cananga odorata (Lam.) Hook.f. & Thomson (ylang ylang oil) for use in all animal species (FEFANA asbl)

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 and efficacy of an essential oil from the flowers of Cananga odorata (Lam.) Hook.f. & Thomson (ylang ylang oil), when used as a sensory additive in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the essential oil under assessment is safe up to the maximum proposed use levels in complete feed of 1 mg/kg for chickens for fattening, 1.5 mg/kg for laying hens, turkeys for fattening and rabbits, 2 mg/kg for piglets, 2.5 mg/kg for pigs for fattening, 3 mg/kg for sows, 4.5 mg/kg for cattle for fattening, sheep, goats and horses, 5 mg/kg for veal calves (milk replacer), fish, dogs and ornamental fish. For cats, the calculated safe concentration in complete feed is 1 mg/kg feed. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumer safety were identified following the use of the additive up to the maximum proposed use level in feed. The essential oil under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of the additive in animal feed under the proposed conditions of use was not expected to pose a risk for the environment. Ylang ylang oil is recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.

Safety and efficacy of a feed additive consisting of an essential oil from the leaves of Laurus nobilis L. (laurel leaf oil) for all animal species (FEFANA asbl)

“…Similar metabolic pathways have been described for estragole (EMA, 2021; reviewed in EFSA FEEDAP Panel, 2022a) and other structurally related p ‐allylalkoxybenzenes.…”

“…For short-living animals, genotoxicity and carcinogenicity endpoints are not considered relevant, therefore a lower magnitude of the MOET (> 100) when comparing estimated exposure with a reference point based on non-neoplastic endpoints is considered adequate (EFSA FEEDAP Panel, 2021b). The FEEDAP Panel identified a NOAEL of 10 mg/kg bw per day for non-neoplastic lesions (effect on liver and the glandular stomach) from a 90-day study in mice with methyleugenol (NTP, 2000).…”

“…Two batches of laurel leaf oil were shown to contain estragole (0.37 and 0.38%), a compound with experimentally proven genotoxicity and carcinogenicity in rodents, as reviewed by the Scientific Committee on Food (EC, 2001), EMA (2021) and in the safety evaluation made by the FEEDAP Panel in the EFSA opinion on ylang ylang oil (EFSA FEEDAP Panel, 2022a). In addition, the presence of elemicin was detected in four batches (0.004–0.011%).…”

“…The following sections focus on methyleugenol, estragole and elemicin, based on the evidence provided by the applicant in the form of literature. For the absorption, distribution, metabolism and excretion (ADME) and the toxicology of estragole, reference is made to the safety evaluation made by the FEEDAP Panel in the EFSA opinion on ylang ylang oil (EFSA FEEDAP Panel, 2022a).…”