An application was submitted to the Food Standards Agency and Food Standards Scotland in April 2023 by AB Enzymes Finland Oy (“the applicant”) for the extension of use of an additive consisting of 6-phytase produced by Trichoderma reesei (CBS 126897) (Quantum ® Blue) under the category ‘zootechnical additive’, functional group ‘digestibility enhancer’, to suckling and weaned piglets and other porcine species and ornamental birds so that the authorisation covers all avian species and all porcine species. The European Food Safety Authority (EFSA) concluded that the final product does not give rise to any safety concerns with regards to the genetic modification of the production strain, as neither the viable cells of the production strain nor its DNA were detected (2013a, 2024). No antibiotic resistance genes from the genetic modification in the production strain were identified. Under the intended conditions of use, Quantum ® Blue is considered safe for the target species. The use of the additive in animal nutrition is considered safe for consumers and for the environment. All forms of the additive should be considered potential respiratory sensitisers, and any inhalation exposure presents a risk. Nevertheless, the Panel noted that the solid formulations are dust-free, which makes inhalation exposure unlikely. Due to the absence of new data, no conclusions could be drawn regarding the potential of the various formulations to cause skin or eye irritation, or to act as skin sensitisers. Quantum ® Blue is efficacious in poultry, pigs for fattening and sows at 250 FTU/kg and in weaned and suckling piglets at 500 FTU/kg, as well as in all laying avian species at 150 FTU/kg. Regarding the extension of use, the additive has the potential to be efficacious in ornamental birds and in porcine species for fattening/reared for reproduction and reproductive animals at 250 FTU/kg, and in suckling and weaned piglets of minor porcine species at 500 FTU/kg complete feed. FSA/FSS has reviewed the applicant’s authorisation application, supporting documentation, and other regulators’ risk assessments, most notably the EFSA risk assessment opinion, and considers sufficient evidence has been demonstrated to conclude without the need for further questions or risk assessment.
Agency et al. (Thu,) studied this question.