EFSA Journal (Mar 2022)

Safety and efficacy of a feed additive consisting of ethoxyquin (6‐ethoxy‐1,2‐dihydro‐2,2,4‐trimethylquinoline) for all animal species (FEFANA asbl)

  • EFSA Panel on Additives, Products or Substances used in Animal Feed (FEEDAP),
  • Vasileios Bampidis,
  • Giovanna Azimonti,
  • Maria de Lourdes Bastos,
  • Henrik Christensen,
  • Birgit Dusemund,
  • Mojca Fašmon 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,
  • Antonio Finizio,
  • Ivana Teodorovic,
  • Gabriele Aquilina,
  • Georges Bories,
  • Jurgen Gropp,
  • Carlo Nebbia,
  • Jordi Tarrés‐Call,
  • Matteo Innocenti

DOI
https://doi.org/10.2903/j.efsa.2022.7166
Journal volume & issue
Vol. 20, no. 3
pp. n/a – n/a

Abstract

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Abstract Ethoxyquin is synthetised from p‐phenetidine, a possible mutagen, which remains in the additive as an impurity at concentrations of < 2.5 mg/kg additive. Ethoxyquin is considered safe for all animal species at the proposed inclusion level of 50 mg/kg complete feed. However, owing the presence of p‐phenetidine, no safe level of the additive in feed for long‐living and reproductive animals could be identified. The FEEDAP Panel derived a health‐based guidance value of 0.006 mg ethoxyquin dimer (EQDM)/kg bw per day and applied it to the sum of ethoxyquin and its transformation products. A maximum total concentration of 50 mg ethoxyquin/kg complete feed for all animal species, except dairy ruminants, would not pose a risk for the consumer. However, in the absence of data on p‐phenetidine residues in tissues and products of animal origin, no conclusion on the safety for the consumer could be drawn. The conclusions on consumer safety assume that the maximum total concentration of 50 mg EQ/kg feed is expressed as the sum of EQ, EQDM, EQI and DHEQ. Exposure of the unprotected user to p‐phenetidine via inhalation should be minimised. No safety concerns for groundwater are expected. It is not possible to conclude on the safety of EQ for the terrestrial compartment. A risk for the aquatic compartment cannot be excluded when ethoxyquin is used in terrestrial animals. Unacceptable risk is not expected for freshwater sediment‐dwelling organisms. A risk of secondary poisoning via the terrestrial food chain is not expected, whereas a risk via the aquatic food chain cannot be excluded. No concerns for aquatic organisms are expected for ethoxyquin used in fish farmed in land‐based system, a risk cannot be excluded for marine sediment dwelling organisms when ethoxyquin is used in sea‐cages. Ethoxyquin is considered efficacious in the range 25–50 mg/kg complete feed.

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