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EFSA journal. European Food Safety Authority2023; 21(4); e07962; doi: 10.2903/j.efsa.2023.7962

Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of Pimpinella anisum L. (anise tincture) 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 a tincture from the fruit of L. (anise tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 1.6%. The product contained on average 0.0414% polyphenols (of which 0.0144% were flavonoids), 0.0009% anisaldehyde, 0.0003% anethole. Estragole (≤ 1.2 mg/kg) was detected in the additive. The estimated maximum content of furocoumarins was 8.2 mg/kg. The use of the anise tincture in feed was not expected to increase the exposure to furocoumarins of those target species that are already fed citrus by-products to a relevant extent (< 10%). For dogs, cats and ornamental fish not normally exposed to citrus by-products, no conclusion could be drawn. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the anise tincture was safe at the maximum proposed use levels in complete feed of 200 mg/kg for horses and 50 mg/kg for poultry, pigs, ruminants, rabbits and salmonids and other fin fish. Anise tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. Since anise tincture may contain furocoumarins, they may cause phototoxicity. When handling the additive, exposure of unprotected users to estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of the anise tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the fruit of and its preparations were recognised to flavour food and their function in feed would be the same, no demonstration of efficacy was necessary.
© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
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Publication Date: 2023-04-17 PubMed ID: 37077302PubMed Central: PMC10107385DOI: 10.2903/j.efsa.2023.7962Google Scholar: Lookup
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Summary

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The research article investigates the safety and effectiveness of a tincture made from the fruit of Pimpinella anisum L. (anise), when used as an additive in animal feed and drinking water for all animal species. The study concludes that the anise tincture is safe to use within stipulated limits, potentially causing irritation and photosensitivity, and its use does not pose a risk to the environment.

Objective and Overview

  • The European Commission requested the European Food Safety Authority (EFSA) to evaluate the safety and efficacy of anise tincture, a feed additive derived from the fruit of the Pimpinella anisum L., used in feed and water for drinking for all animal species.
  • The anise tincture product contained a dry matter content of approximately 1.6%, polyphenols, anisaldehyde, anethole, estragole, and furocoumarins.

Safety Evaluation

  • The researchers analyzed whether the use of the anise tincture would significantly increase the exposure to furocoumarins in animal species already being fed citrus by-products. The result was a less than 10% increase, which was not deemed significant. However, they could not reach a conclusion for dogs, cats, and ornamental fish who were not typically exposed to citrus by-products.
  • The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) deemed the tincture safe at the proposed maximum levels in complete feed of 200 mg/kg for horses and 50 mg/kg for poultry, pigs, ruminants, rabbits, and fish.
  • The anise tincture was considered to be irritant to the skin and eyes, and a dermal and respiratory sensitizer. It could also cause phototoxicity due to the presence of furocoumarins.
  • It was found that handlers of the additive could potentially be exposed to estragole. To minimize risk, the researchers suggested reducing the exposure.

Efficacy and Environmental Impact

  • The researchers determined that using the anise tincture as a flavor in animal feed did not pose a risk to the environment.
  • As the fruit of Pimpinella anisum L. and its preparations are known to flavor food, no efficacy demonstration was necessary.

Cite This Article

APA
Bampidis V, Azimonti G, Bastos ML, Christensen H, Durjava M, Kouba M, López-Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Brantom P, Chesson A, Westendorf J, Manini P, Pizzo F, Dusemund B. (2023). Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of Pimpinella anisum L. (anise tincture) for use in all animal species (FEFANA asbl). EFSA J, 21(4), e07962. https://doi.org/10.2903/j.efsa.2023.7962

Publication

EFSA journal. European Food Safety Authority
ISSN: 1831-4732
NlmUniqueID: 101642076
Country: United States
Language: English
Volume: 21
Issue: 4
Pages: e07962
PII: e07962

Researcher Affiliations

Bampidis, Vasileios
    Azimonti, Giovanna
      Bastos, Maria de Lourdes
        Christensen, Henrik
          Durjava, Mojca
            Kouba, Maryline
              López-Alonso, Marta
                López Puente, Secundino
                  Marcon, Francesca
                    Mayo, Baltasar
                      Pechová, Alena
                        Petkova, Mariana
                          Ramos, Fernando
                            Sanz, Yolanda
                              Villa, Roberto Edoardo
                                Woutersen, Ruud
                                  Brantom, Paul
                                    Chesson, Andrew
                                      Westendorf, Johannes
                                        Manini, Paola
                                          Pizzo, Fabiola
                                            Dusemund, Birgit

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