EFSA Journal (Nov 2020)

Safety and efficacy of Nutrase P (6‐phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds

  • EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),
  • Vasileios Bampidis,
  • Giovanna Azimonti,
  • Maria de Lourdes Bastos,
  • Henrik Christensen,
  • Birgit Dusemund,
  • Maryline Kouba,
  • Mojca Fašmon Durjava,
  • Marta López‐Alonso,
  • Secundino López Puente,
  • Francesca Marcon,
  • Baltasar Mayo,
  • Alena Pechová,
  • Mariana Petkova,
  • Fernando Ramos,
  • Yolanda Sanz,
  • Roberto Edoardo Villa,
  • Ruud Woutersen,
  • Pier Sandro Cocconcelli,
  • Boet Glandorf,
  • Lieve Herman,
  • Miguel Maradona Prieto,
  • Guido Rychen,
  • Maria Saarela,
  • Montserrat Anguita,
  • Jaume Galobart,
  • Lucilla Gregoretti,
  • Matteo Innocenti,
  • Gloria Lopez‐Galvez,
  • Elisa Pettenati,
  • Konstantinos Sofianidis,
  • Rosella Brozzi,
  • Maria Vittoria Vettori

DOI
https://doi.org/10.2903/j.efsa.2020.6282
Journal volume & issue
Vol. 18, no. 11
pp. n/a – n/a

Abstract

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Abstract Nutrase P is available in powder, granulated, thermostable granulate and liquid forms. It is based on a 6‐phytase produced by a genetically modified strain of K. phaffii. The production strain contains four copies of the ampicillin resistance gene and one copy of a bleomycin resistance gene. Although Nutrase PTS 10,000 (thermostable granulate) and Nutrase PG 10,000 (granulate) do not raise concern regarding the presence of viable cells of the production strain and its recombinant DNA, uncertainties remain on the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder). The FEEDAP Panel cannot conclude on the safety of the additive, in any form, for the target species for which application is made due to major limitations in the study in chickens for fattening provided. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concludes that additive does not pose a toxicological safety concern regarding the consumers of the products obtained from animals receiving the additive. The additive, in its all formulations, is not a skin or eye irritant and is not dermal sensitiser. However, owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The active substance of the additive is a protein and as such would not raise concerns for the environment. Considering that the production strain harbours AMR genes and there is uncertainties regarding the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder), the Panel cannot conclude on the safety of these two formulations of the additive for the target species, consumer, user and environment. Owing to the lack of data, the FEEDAP Panel cannot conclude on the efficacy of the additive.

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