EFSA Journal (Oct 2024)

Safety and efficacy of a feed additive consisting of an essential oil derived from leaves and terminal branchlets of Melaleuca alternifolia (Maiden & Betche) Cheel (tea tree oil) for use in all animal species (FEFANA asbl)

  • EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),
  • Roberto Edoardo Villa,
  • Giovanna Azimonti,
  • Eleftherios Bonos,
  • Henrik Christensen,
  • Mojca Durjava,
  • Birgit Dusemund,
  • Ronette Gehring,
  • Boet Glandorf,
  • Maryline Kouba,
  • Marta López‐Alonso,
  • Francesca Marcon,
  • Carlo Nebbia,
  • Alena Pechová,
  • Miguel Prieto‐Maradona,
  • Ilen Röhe,
  • Katerina Theodoridou,
  • Maria de Lourdes Bastos,
  • Paul Brantom,
  • Andrew Chesson,
  • Josef Schlatter,
  • Johannes Westendorf,
  • Yvette Dirven,
  • Paola Manini

DOI
https://doi.org/10.2903/j.efsa.2024.9026
Journal volume & issue
Vol. 22, no. 10
pp. n/a – n/a

Abstract

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Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tea tree oil obtained from leaves and terminal branchlets of Melaleuca alternifolia (Maiden & Betche) Cheel when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that tea tree oil was very unlikely to be of safety concern for long‐living and reproductive animals and is of no concern for target species for fattening at the following concentrations in complete feed: 1.1 mg/kg for chickens for fattening, 1.5 mg/kg for turkeys for fattening, 1.7 mg/kg for laying hens, 2.0 mg/kg for piglets, 2.4 mg/kg for pigs for fattening, 3.1 mg/kg for sows, 5.0 mg/kg for veal calves (milk replacer) and salmonids, 4.4 mg/kg for cattle for fattening, sheep/goats and horses, 2.9 mg/kg for dairy cows, 1.8 mg/kg for rabbits, 0.9 mg/kg for cats, 5.3 mg/kg for dogs, 6.6 for crustaceans and 15 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is very unlikely to be of safety concern at 1.1 mg/kg complete feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. Regarding user safety, tea tree oil should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. It is classified as a reprotoxic substance (category 1B) following CLP criteria and should be handled accordingly. Since M. alternifolia and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

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