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EFSA journal. European Food Safety Authority2024; 22(10); e9026; doi: 10.2903/j.efsa.2024.9026

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).

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 (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 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.
© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
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Publication Date: 2024-10-28 PubMed ID: 39469429PubMed Central: PMC11513608DOI: 10.2903/j.efsa.2024.9026Google Scholar: Lookup
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  • Journal Article

Summary

This research summary has been generated with artificial intelligence and may contain errors and omissions. Refer to the original study to confirm details provided. Submit correction.

Overview

  • The research evaluates the safety and effectiveness of tea tree oil, derived from Melaleuca alternifolia leaves and branchlets, as a feed additive for various animal species.
  • The study assesses appropriate dosage levels ensuring safety for animals, consumers, and the environment, and notes necessary precautions for handling the oil.

Objectives and Background

  • The European Commission requested EFSA’s scientific opinion on tea tree oil’s use as a sensory feed additive for all animal species.
  • Tea tree oil, known for its flavoring properties in human food, is proposed to be added to animal feed to enhance sensory attributes.

Safety Assessment for Animals

  • EFSA’s FEEDAP Panel analyzed the safety profile of tea tree oil when included in feed for:
    • Long-living and reproductive animals
    • Target species intended for fattening
  • Established maximum safe concentrations in complete feed vary by species, for example:
    • Chickens for fattening: 1.1 mg/kg
    • Turkeys for fattening: 1.5 mg/kg
    • Laying hens: 1.7 mg/kg
    • Piglets: 2.0 mg/kg
    • Sows: 3.1 mg/kg
    • Veal calves (milk replacer) and salmonids: 5.0 mg/kg
    • Dogs: 5.3 mg/kg
    • Ornamental fish: 15 mg/kg
  • These dosage recommendations can be extrapolated to other physiologically similar species.
  • For species not specifically evaluated, 1.1 mg/kg in complete feed is considered very unlikely to pose safety concerns.

Consumer and Environmental Safety

  • Use of tea tree oil at the recommended maximum levels in animal feed is not expected to pose risks to consumers consuming animal products.
  • There are no identified concerns regarding environmental impact from the additive’s use in feed.

User Safety Considerations

  • Tea tree oil may:
    • Irritate skin and eyes upon contact
    • Act as a dermal and respiratory sensitiser, potentially triggering allergic reactions
  • It is classified as a reprotoxic substance category 1B under the Classification, Labelling and Packaging (CLP) regulation, meaning it could adversely affect reproductive health.
  • Handling of the additive requires caution, implementing safety measures to minimize exposure risks.

Efficacy of Tea Tree Oil as a Feed Additive

  • Given that tea tree oil is already recognized and authorized as a food flavoring agent, its functionality in animal feed is considered analogous.
  • Therefore, no additional efficacy studies were deemed necessary to support its use for sensory enhancement in animal feed.

Summary

  • The EFSA evaluation supports the safe use of tea tree oil as a sensory feed additive across a wide range of animal species at specified dosages.
  • The additive poses no significant risks to animal health, consumers, or the environment when used within recommended limits.
  • User exposure requires precautions due to irritation and reproductive toxicity concerns.
  • The additive’s efficacy is acknowledged without need for further demonstration based on its food flavoring approval.

Cite This Article

APA
Villa RE, Azimonti G, Bonos E, Christensen H, Durjava M, Dusemund B, Gehring R, Glandorf B, Kouba M, López-Alonso M, Marcon F, Nebbia C, Pechová A, Prieto-Maradona M, Röhe I, Theodoridou K, Bastos ML, Brantom P, Chesson A, Schlatter J, Westendorf J, Dirven Y, Manini P. (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 J, 22(10), e9026. https://doi.org/10.2903/j.efsa.2024.9026

Publication

EFSA journal. European Food Safety Authority
ISSN: 1831-4732
NlmUniqueID: 101642076
Country: United States
Language: English
Volume: 22
Issue: 10
Pages: e9026
PII: e9026

Researcher Affiliations

Villa, Roberto Edoardo
    Azimonti, Giovanna
      Bonos, Eleftherios
        Christensen, Henrik
          Durjava, Mojca
            Dusemund, Birgit
              Gehring, Ronette
                Glandorf, Boet
                  Kouba, Maryline
                    López-Alonso, Marta
                      Marcon, Francesca
                        Nebbia, Carlo
                          Pechová, Alena
                            Prieto-Maradona, Miguel
                              Röhe, Ilen
                                Theodoridou, Katerina
                                  Bastos, Maria de Lourdes
                                    Brantom, Paul
                                      Chesson, Andrew
                                        Schlatter, Josef
                                          Westendorf, Johannes
                                            Dirven, Yvette
                                              Manini, Paola

                                                Conflict of Interest Statement

                                                If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu.

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