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

safety, efficacy, zootechnical additives, 6‐phytase, poultry
First published in the EFSA Journal
12 novembre 2020
Adopted
30 septembre 2020
Type
Scientific Opinion

Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.

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.

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis, 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 and Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2020.6282
EFSA Journal 2020;18(11):6282
Question Number
On request from
European Commission