Safety and efficacy of the feed additive consisting of 6-phytase (produced by Komagataella phaffii CGMCC 7.19) (Nutrase P) for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds (Nutrex NV)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 6-phytase produced by a genetically modified strain of Komagataella phaffii (CGMCC 7.19) (Nutrase P) for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds. The additive is available in solid (Nutrase PD 100,000, Nutrase PG 10,000 and Nutrase PTS 10,000) and liquid (Nutrase PL 10,000) forms. In 2020, the FEEDAP Panel issued an opinion on the safety and efficacy of the product and concluded that uncertainties remained on the presence of viable cells and recombinant DNA of the production strain in two of the formulations (Nutrase PL 10,000 and Nutrase PD 100,000). Moreover, the Panel could not conclude on the safety and the efficacy of the additive for the target species at the recommended level of 250 FTU/kg complete feed. The applicant provided supplementary information to address the limitations identified in that assessment and requested to increase the minimum recommended use level to 500 FTU/kg complete feed. No viable cells and recombinant DNA of the production strain were detected in Nutrase PL 10,000 and Nutrase PD 100,000. Therefore, the Panel concluded that the additive, in any formulations, does not pose any safety concern with regard to the production strain. Based on the results of a new tolerance trial, the Panel concluded that Nutrase P is safe for the target species. The additive in any formulation is safe for the consumers and the environment, but should be considered a respiratory sensitiser. Considering the two long-term trials in chickens for fattening previously evaluated and the new trial submitted, the Panel concluded that the additive is efficacious in chickens for fattening, other poultry species for fattening or reared for laying and ornamental birds at 1,500 FTU/kg complete feed.

Automated summary

EFSA conducted a scientific assessment on the safety and efficacy of 6-phytase produced by a genetically modified strain of Komagataella phaffii for various types of birds. The additive was found to be safe and effective for use in feed, with the exception of respiratory sensitization. The recommended level of use was increased to 1,500 FTU/kg complete feed.