Safety and efficacy of feed additives consisting of essential oils from the bark and the leaves of Cinnamomum verum J. Presl (cinnamon bark oil and cinnamon leaf 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 essential oils from the bark and the leaves of Cinnamomum verum J. Presl (cinnamon bark oil and cinnamon leaf oil), when used as sensory additives (flavourings) in feed and water for drinking for all animal species. Owing to the presence of styrene in the essential oils under assessment, the FEEDAP Panel is not in the position to conclude on the safety for long‐living animals and animals for reproduction. For ‘short‐living’ animals, the FEEDAP Panel concluded that cinnamon bark oil and cinnamon leaf oil are considered as safe up to the maximum proposed use levels in complete feed. For ‘short‐living’ animals, the Panel considered the use of cinnamon bark oil in water for drinking as safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. For cinnamon leaf oil, the proposed use level in water for drinking of 3 mg/L is considered as safe for ‘short‐living’ animals. No concerns for consumers were identified following the use of the additives at the use level considered safe in feed for the target species. Based on the presence of safrole ≥0.1%, cinnamon leaf oil and bark oil are classified as carcinogen (category 1B) and handled accordingly. The use of the additives under the proposed conditions in animal feed was not expected to pose a risk for the environment. Since C. verum and its preparations are recognised to flavour food and its function in feed would be essentially the same, no further demonstration of efficacy is considered necessary for cinnamon essential oils.

Safety and efficacy of a feed additive consisting of an essential oil from the seeds of Myristica fragrans Houtt. (nutmeg oil) for all animal species (FEFANA asbl)

“…Similar metabolic pathways have been described for safrole (European Commission, 2001; reviewed in EFSA FEEDAP Panel, 2022a) and for methyleugenol (IARC, 2018; reviewed in EFSA FEEDAP Panel, 2023a).…”

“…The following sections focus on the p‐ allylalkoxybenzenes, mainly on myristicin, based on the evidence provided by the applicant in the form of several literature searches. For the absorption, distribution, metabolism and excretion (ADME) and the toxicology of safrole, reference is made to the safety evaluation made by the FEEDAP Panel in the EFSA opinion on cinnamon bark oil and cinnamon leaf oil (EFSA FEEDAP Panel, 2022a) and for the ADME and toxicology of methyleugenol to the opinion on laurel leaf oil (EFSA FEEDAP Panel, 2023a).…”

“…Nutmeg oil contains safrole (range: 1.69–2.30%) and methyleugenol (0.18–0.32%), two compounds with experimentally proven genotoxicity and carcinogenicity in rodents as reviewed by the Scientific Committee on Food (European Commission, 2001) and IARC (2018). The genotoxicity and carcinogenicity studies with safrole and methyleugenol and other structurally related p‐ allylalkoxybenzenes were reviewed by the FEEDAP Panel (EFSA FEEDAP Panel, 2022a,c, 2023a).…”

“…In the previous assessments of essential oils containing p‐ allylalkoxybenzenes, a read‐across from methyleugenol to other p‐ allylalkoxybenzenes was applied based on considerations on the structural and metabolic similarity among all the components of the assessment group (EFSA FEEDAP Panel, 2022a,b,c, 2023a,b).…”

Safety and efficacy of a feed additive consisting of an essential oil derived from fresh leaves of Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L. (cajuput oil) for use in all animal species (FEFANA asbl)

“…Read‐across was also applied from β‐caryophyllene [01.007] to 3,7,10‐humulatriene [01.043] in CG 31, VI. The NOAEL of 222 mg/kg bw per day for β‐caryophyllene [01.007] was halved to take into account the uncertainty in read‐across (EFSA FEEDAP Panel, 2023b).…”