Safety and efficacy of the product Quantum™ Phytase 5000 L and Quantum™ Phytase 2500 D (6-phytase) as a feed additive for chickens for fattening, laying hens, turkeys for fattening, ducks for fattening and piglets (weaned)
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and the Panel on Genetically Modified Organisms (GMO) were asked to deliver a scientific opinion on the safety and efficacy of the product Quantum™ Phytase 5000 L and Quantum™ Phytase 2500 D (6-phytase) as a feed additive for chickens for fattening, laying hens, turkeys for fattening, ducks for fattening and piglets (weaned). The additive Quantum™ Phytase (6-phytase) is produced in two formulations, i.e. Quantum™ Phytase 5000 L (liquid) and Quantum™ Phytase 2500 D (granular). It is intended for use as a feed additive for chickens, turkeys and ducks for fattening, laying hens and piglets (weaned) within the category of zootechnical additives, in functional groups 1) digestibility enhancer and 2) substances favourably affecting the environment. This additive is produced by fermentation of yeast Pichia pastoris sNOV9Xpp27, which is genetically modified to contain a synthetic gene encoding a thermotolerant 6-phytase. Conclusive evidence was given that the 6-phytase produced by P. pastoris sNOV9Xpp27 is identical to the enzyme predicted from the deduced amino acid sequence but is present in different glycosylated forms. Histidinol dehydrogenase HIS4 was used as the selectable marker gene and no antibiotic resistance marker sequences are present in the final production strain. The safety of the donor and the recipient organisms is based on the concept of familiarity. No harmful sequences have been introduced in the production strain. After fermentation, the enzyme is separated from the cells and concentrated. The final enzyme preparation contains no cultivable production organisms, no antimicrobial activity or mycotoxins, and the level of the newly introduced DNA is below the limit of detection. The efficacy of Quantum™ Phytase 5000 L and Quantum™ Phytase 2500 D has been demonstrated in chickens for fattening (500 FTU kg-1), laying hens (2000 FTU kg-1), turkeys for fattening (1000 FTU kg-1) and piglets (100 FTU kg-1). Efficacy in ducks for fattening (250 FTU kg-1) can be extrapolated based on the efficacy for chickens and turkeys for fattening and supported by a dose titration study in which positive results were obtained at this dose level. Based on the tolerance studies provided by the applicant, Quantum™ Phytase 5000 L and Quantum™ Phytase 2500 D has been shown to be safe in chickens for fattening, laying hens, turkeys for fattening, ducks for fattening and piglets at the respective maximum recommended doses. Based upon a lack of mutagenicity in three assays and the absence of any relevant effects in a 90-day study, it is concluded that the use of Quantum™ Phytase as an additive in animal feed would pose no risks for the consumer. The product is a mild irritant for the eye and a dermal se nsitiser. It is also presumed, as with all enzyme products, to be a potential respiratory sensitiser. Although no study is provided on the effects of inhalation exposure, any precautions appropriate to protecting the user from the irritant and sensitising properties would be sufficient to protect against any likely inhalation toxicity. The active ingredient of Quantum™ Phytase is a protein and as such will be degraded/inactivated during the passage through the digestive tract of animals. Therefore, no further environmental risk assessment is required.