Safety and efficacy of a feed additive consisting of an essential oil from the fruit of Cuminum cyminum L. (cumin oil) for use 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 and efficacy of an essential oil obtained from the fruit of Cuminum cyminum L. (cumin oil), when used as a sensory additive in feed and water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of cumin oil up to the maximum proposed use levels in feed of 15 mg/kg complete feed is considered as safe for all animal species. The FEEDAP Panel considered the use 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. No concerns for consumers were identified following the use of cumin oil up to the maximum proposed use level in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the essential oil, exposure of unprotected users to estragole (and dillapiole) cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of cumin oil at the proposed use level in feed is not expected to pose a risk to the environment. Since C. cyminum and its preparations are recognised to flavour food and 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 seeds of Myristica fragrans Houtt. (nutmeg oil) for all animal species (FEFANA asbl)

“…Dose–response modelling using hepatocellular carcinomas in male rats as a response yielded a BMD lower confidence limit for a benchmark response of 10% (BMDL 10 ) of 22.2 mg/kg bw per day (Suparmi et al., 2019). This BMDL 10 value was selected as reference point for the assessment group of p‐ allylalkoxybenzenes (EFSA FEEDAP Panel, 2022b) irrespective of their relative potency (EFSA FEEDAP Panel, 2022c).…”

“…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).…”

“…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).…”

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)

“…The NOAEL of 34 mg/kg bw per day for deca‐2(trans),4(trans)‐dienal [05.140] was extrapolated using read‐across to phellandral in CG 7 (EFSA FEEDAP Panel, 2022 ).…”