Safety Assessment on the Safety and Efficacy of a Feed Additive Containing Endo-1,4-Beta-Xylanase Produced by <i>Aspergillus Niger</i> CBS 109.713, and Endo-1,4-Beta-Glucanase Produced by <i>Aspergillus Niger</i> DSM 18404 for Its Use in All Pigs (RP

An application was submitted to the Food Standards Agency and Food Standards Scotland in January 2023 from BASF SE (‘the applicant’) for an extension of use of an additive containing endo-1,4-beta-xylanase produced by Aspergillus niger CBS 109.713, and endo-1,4-beta-glucanase produced by Aspergillus niger DSM 18404, under the category of ‘zootechnical additives’ and functional group ‘digestibility enhancers’. The additive is proposed to be used at a minimum inclusion rate of 560 TXU/kg and 250 TGU/kg of complete feed (12% moisture) for all pigs. Under assimilated Regulations (EU) No 1404/2013, 2020/1371, 271/2009 and 1068/2011, the additive is currently authorised in GB for its use for pigs for fattening (EU 2013), lactating sows (EU 2020), weaned piglets; chickens for fattening; laying hens; turkeys for fattening; ducks for fattening (EC 2009) and chickens reared for laying, turkeys for breeding purposes, turkeys reared for breeding, other minor avian species (other than ducks for fattening) and ornamental birds (EU 2011). This application requested an extension of use in feed for all pigs. The FSA/FSS carried out an assessment of the dossier, taking previous evaluations into consideration, and concluded that the additive was correctly identified and characterised as there were no changes from the previous assessment. No significant concerns were raised for the identity, characterisation and condition of use section of the dossier. FSA/FSS concluded the additive is safe for consumers, the environment and the target species up to the maximum inclusion level of 840 TXU/kg xylanase and 375 TGU/kg glucanase of complete feed. Both formulations of the additive are considered to be non-irritant to the skin and eyes but should be considered respiratory sensitisers and potential skin sensitisers. FSA/FSS concluded the additive is efficacious in weaned piglets and has the potential to be efficacious in pigs for fattening and lactating sows. This demonstrates that the additive favourably affects animal production by affecting the digestibility of feedingstuffs. No conclusion could be drawn on the efficacy of the additive in gestating sows. This safety assessment represents the opinion of the FSA and FSS.