Safety and efficacy of feed additives consisting of essential oils derived from the flower buds or the leaves of Syzygium aromaticum (L.) Merr. & L.M. Perry (clove bud oil and clove leaf oils) for 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 essential oils from the flower buds or the leaves of Syzygium aromaticum (L.) Merr. & L.M. Perry: clove bud oil, clove leaf oil and a β‐caryophyllene‐rich fract...

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Main Authors: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Mojca Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Paul Brantom, Andrew Chesson, Josef Schlatter, Johannes Westendorf, Yvette Dirven, Paola Manini, Birgit Dusemund
Format: Article
Language:English
Published: Wiley 2023-07-01
Series:EFSA Journal
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Online Access:https://doi.org/10.2903/j.efsa.2023.8183
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Summary:Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of essential oils from the flower buds or the leaves of Syzygium aromaticum (L.) Merr. & L.M. Perry: clove bud oil, clove leaf oil and a β‐caryophyllene‐rich fraction of clove leaf oil (CCL oil), when used as sensory additives in feed and water for drinking for all animal species. Clove oils contain methyleugenol (up to 0.13%). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of clove oils is very unlikely to induce adverse effects in long‐living and reproductive animals and is considered of no concern for target species for fattening at the following concentrations in complete feed: 25–50 mg/kg for clove bud oil, 28–100 mg/kg for clove leaf oil and 20 mg/kg for CCL oil. The FEEDAP Panel considered that the use in water for drinking alone or in conjunction with use in feed should not exceed the daily amount that is considered very unlikely to induce adverse effects or of no concern when consumed via feed alone. No concerns for consumers were identified following the use of clove oils up to the highest proposed use level in feed. The additives under assessment should be considered as irritant to skin and eyes and the respiratory tract and as skin sensitisers. When handling the essential oils, exposure of unprotected users to methyleugenol may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of clove oils at the proposed use level in feed was not expected to pose a risk for the environment. Since clove bud oil and clove leaf oil are recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.
ISSN:1831-4732