Safety and efficacy of a feed additive consisting of an essential oil from the fruits of Litsea cubeba (Lour.) Pers. (litsea berry 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 fruits of Litsea cubeba (Lour.) Pers. (litsea berry oil), when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that litsea berry oil is safe up to the maximum proposed use level of 125 mg/kg complete feed for ornamental fish. For the other species, the calculated safe concentration in complete feed are 11 mg/kg for chicken for fattening, 16 mg/kg for laying hen, 14 mg/kg for turkey for fattening, 19 mg/kg for piglet, 23 mg/kg for pig for fattening, 28 mg/kg for lactating sow, 48 mg/kg for veal calf (milk replacer), 43 mg/kg for cattle for fattening, sheep, goat and horse, 28 mg/kg for dairy cow, 17 mg/kg for rabbit, 47 mg/kg for salmon, 50 mg/kg for dog and 8.5 mg/kg for cat. The FEEDAP Panel also concluded that the use of litsea berry oil at the maximum proposed use level in water for drinking of 1 mg/kg is safe for all animal species. Simultaneous use in feed and water for drinking may lead to the maximum safe dose being exceeded. No concerns for consumer safety were identified following the use of the additive up to the highest safe use level in feed for the target animals. 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 was not expected to pose a risk for the environment. Litsea berry 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 was considered necessary.

Safety and efficacy of a feed additive consisting of an essential oil from Cinnamomum camphora (L.) J. Presl (camphor white oil) for use in all animal species (FEFANA asbl)

“…The approach followed by the FEEDAP Panel to assess the safety and the efficacy of camphor white oil from C. camphora is in line with the principles laid down in Regulation (EC) No 429/2008 11 and the relevant guidance documents: Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements (EFSA Scientific Committee, 2009 ); Compendium of botanicals that have been reported to contain toxic, addictive, psychotropic or other substances of concern (EFSA, 2012 ); Guidance for the preparation of dossiers for sensory additives (EFSA FEEDAP Panel, 2012b ); Guidance on studies concerning the safety of use of the additive for users/workers (EFSA FEEDAP Panel, 2012c ); Guidance on the identity, characterisation and conditions of use of feed additives (EFSA FEEDAP Panel, 2017a ); Guidance on the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017b ); Guidance on the assessment of the safety of feed additives for the consumer (EFSA FEEDAP Panel, 2017c ); Guidance on the assessment of the safety of feed additives for the environment (EFSA FEEDAP Panel, 2019 ); Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2018 ); Guidance document on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals (EFSA Scientific Committee, 2019a ); Statement on the genotoxicity assessment of chemical mixtures (EFSA Scientific Committee, 2019b ); Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Scientific Committee, 2019c ); General approach to assess the safety for the target species of botanical preparations which contain compounds that are genotoxic and/or carcinogenic. 12…”

Safety and efficacy of a feed additive consisting of a fraction of the essential oil from the fruit and leaves of Illicium verum Hook.f. (star anise terpenes) for use in all animal species (FEFANA asbl)

“…The data submitted by the applicant showed that the production process of the additive star anise terpenes results in an enrichment of the genotoxic carcinogen estragole from star anise oil. This does not accord with the principles outlined in the general approach to assess the safety for the target species of botanical preparations which contain compounds that are genotoxic and/or carcinogenic when used as feed additives (EFSA FEEDAP Panel, 2021a). Any manufacturing processes of botanical feed additives should avoid selective extraction and enrichment of genotoxic and/or carcinogenic substances and should aim at the reduction of these substances.…”

“…The FEEDAP Panel notes that the margin of exposure (MOE) approach was originally designed to allow an assessment of additives with impurities with genotoxic/carcinogenic activity (EFSA, 2005; EFSA SC, 2012), and was later adapted to the assessment of the safety for the target species of feed additives of botanical origin in which genotoxic and/or carcinogenic substances cannot be fully avoided (EFSA FEEDAP Panel, 2021a). In the present feed additive, terpenes and estragole, a genotoxic carcinogen, are selectively extracted and substantially enriched.…”

Risk Assessment of Combined Exposure to Multiple Chemicals at the European Food Safety Authority: Principles, Guidance Documents, Applications and Future Challenges

“…Pers. [ 91 ], cinnamon tincture from the bark of Cinnamomum verum J. Presl [ 92 ], camphor white oil from Cinnamomum camphora (L.) J. Presl [ 93 ], buchu leaf oil from the leaves of Agathosma betulina (P.J. Bergius) Pillans [ 94 ], ylang ylang oil from the flowers of Cananga odorata (Lam.)…”