Assessment of the feed additive consisting of 6-phytase (produced with Trichoderma reesei CBS 126897) (Quantum® Blue) for the renewal of its authorisation for poultry, weaned piglets, pigs for fattening and sows (4a19), and its extension of use to other porcine species and ornamental birds (AB Enzymes Finland Oy)

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of 6-phytase produced with a genetically modified strain of Trichoderma reesei (CBS 126897) (Quantum® Blue) as a zootechnical feed additive for poultry, piglets, pigs for fattening and sows, other porcine species and ornamental birds. The additive is currently authorised for use in feed for laying birds, poultry other than laying birds, weaned piglets, pigs for fattening and sows. This scientific opinion concerns the request for the renewal of the authorisation of the additive for these species and the extension of use to suckling piglets and other porcine species and ornamental birds. The additive is available in two solid (Quantum® Blue 5 G and 40 P) and two liquid formulations (Quantum® Blue 5 and 10 L). Some changes in the composition of the product have been implemented since the first authorisation. The applicant provided evidence that the additive complies with the terms of the authorisation. The FEEDAP Panel concluded that all formulations of the additive remain safe for the target species, consumers and the environment, and that the extension of use to the new species would not affect these conclusions. Regarding user safety, all the forms of the additive should be considered as respiratory sensitisers. The solid forms of the additive are dust free; therefore, the exposure of users through inhalation is unlikely. No specific information was submitted for the four formulations of the additive under assessment regarding their potential to be skin and eye irritants and skin sensitisers. In the absence of data, the FEEDAP Panel is not in the position to conclude on the potential of the additive to be skin and eye irritants or skin sensitisers. There is no need for the assessment of efficacy in poultry, weaned piglets, pigs for fattening and sows in the context of the renewal of the authorisation. The FEEDAP Panel considers that the additive has the potential to be efficacious in ornamental birds at 250 FTU/kg complete feed and in suckling piglets and in suckling and weaned piglets of minor porcine species at 500 FTU/kg and in minor porcine species for fattening/reared for reproduction and reproductive animals at 250 FTU/kg complete feed.