Assessment on the Safety and Efficacy of a Feed Additive Consisting of Endo-1,4-Beta-Xylanase Produced by <i>Trichoderma Reesei</i> ATCC PTA-5588, Protease Produced by <i>Bacillus Subtilis</i> CBS 148232, and Alpha-Amylase Produced by <i>Bacillus Lic

An application was submitted to the Food Standards Agency and Food Standards Scotland in August 2023 from Genencor International B.V. (“the applicant”) for the new authorisation of an additive consisting of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232, and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 (Axtra® XAP 104 TPT), under the category ‘zootechnical feed additive’, functional group ‘digestibility enhancer’, for its use in all growing poultry species. In 2020, the European Food Safety Authority (EFSA) could not conclude on the safety of the additive due to: uncertainty on the presence of viable cells of the genetically modified strain Trichoderma reesei ATCC PTA-5588; uncertainty regarding the manufacturing process of the protease; and uncertainty regarding the test item used in the toxicological studies of the xylanase, which prevented the FEEDAP Panel reaching a conclusion on the safety, including the endpoint of genotoxicity of the xylanase component of the additive. Additionally, the Panel could not conclude on the efficacy of the additive as a digestibility enhancer in laying hens due to an insufficient number of studies. The EFSA 2023 opinion states that new data was submitted by the applicant to address some of the limitations previously identified. In addition, a change of the production strain B. subtilis ATCC SD-2107 to B. subtilis CBS 148232 was declared by the applicant. The EFSA concluded that at the recommended use level (1,000 xylanase units (U), 100 amylase U and 2,000 protease U per kg feed), the additive is safe for the target species. The additive is also safe for the consumers and environment. However, no conclusions were reached on the eye and skin irritancy potential of the additive and its skin sensitisation potential. The additive is considered a respiratory sensitiser due to the proteinaceous nature of the active substances. At the level of 2,000 xylanase U, 200 amylase U and 4,000 protease U per kg feed (double the minimum recommended use level), the additive is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay. However, the Panel could not conclude on the efficacy of the additive for laying hens due to lack of data. The FSA and FSS noted that EFSA 2020 and 2023 opinion assessed the safety and the efficacy of the additive for chickens for fattening, laying hens and minor poultry species. However, in the application submitted to FSA and FSS, the applicant requested an authorisation of the additive for its use in all growing poultry species. The FSA and FSS considers sufficient evidence has been provided to extrapolate conclusions to all growing poultry species. 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.