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EFSA journal. European Food Safety Authority2024; 22(11); e9016; doi: 10.2903/j.efsa.2024.9016

Safety and efficacy of a feed additive consisting of an essential oil derived from the flowering stems of Salvia sclarea L. (clary sage 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 from the fresh or dried flowering stems of L. (clary sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for veal calves (milk replacers), cattle for fattening, sheep/goats, 10 mg/kg for horses, 20 mg/kg for dogs, salmonids and ornamental fish. For the other target species, the calculated safe concentrations were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 9 mg/kg for piglets, 11 mg/kg for pigs for fattening, 14 mg/kg for sows, 13 mg/kg for dairy cows, 8 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 4 mg/kg complete feed. The FEEDAP Panel considered that the use level in water of clary sage oil is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of clary sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the flowering stems of is 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: 2024-11-14 PubMed ID: 39545222PubMed Central: PMC11561422DOI: 10.2903/j.efsa.2024.9016Google Scholar: Lookup
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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.

This study evaluates the safety and efficacy of clary sage oil, an essential oil derived from the flowering stems of Saliva sclarea L., as an additive in both animal feed and drinking water. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded it is safe for various animal species within specific concentration limits and safe for the consumer and the environment.

Overview of the Research

  • The research was conducted by EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) following a request from the European Commission.
  • The aim was to evaluate the safety and effectiveness of clary sage oil, an essential oil extracted from the fresh or dried flowering stems of Salvia sclarea L., as a sensory additive in feed and in water for drinking for all animal species.
  • The research managed to establish safe consumption levels for various animal species and affirmed that the essential oil is safe for the environment and consumers.

Findings of the Research

  • The research established safe maximum use levels in complete animal feed: 15 mg/kg for veal calves, cattle for fattening, sheep/goats; 10mg/kg for horses; 20mg/kg for dogs, salmonids, and ornamental fish. For other species, it calculated safe concentrations ranging from 4mg/kg to 14mg/kg.
  • The use level in water was considered safe as long as the total daily intake of the additive does not exceed the safe daily amount consumed via feed.
  • The panel extrapolated these conclusions to other physiologically related species.

Implications for Users and Consumers

  • Regarding user safety, clary sage oil should be considered an irritant to the skin and eyes and regarded as a dermal and respiratory sensitizer.
  • The research affirms that the use of clary sage oil in animal feed, under proposed conditions, is safe for the consumer and the environment.
  • Given the widely recognised use of the oil for flavouring food, the panel did not find it necessary to demonstrate further efficacy regarding its identical function in feed.

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 the flowering stems of Salvia sclarea L. (clary sage oil) for use in all animal species (FEFANA asbl). EFSA J, 22(11), e9016. https://doi.org/10.2903/j.efsa.2024.9016

Publication

EFSA journal. European Food Safety Authority
ISSN: 1831-4732
NlmUniqueID: 101642076
Country: United States
Language: English
Volume: 22
Issue: 11
Pages: e9016
PII: e9016

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

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