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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product containing endo‐1,4‐β‐xylanase (ECONASE® XT) as a zootechnical feed additive (digestibility enhancer) for pigs for fattening, laying hens and minor poultry species. ECONASE® XT is available in two liquid and three solid forms and is produced with a genetically modified strain of Trichoderma reesei (CBS 114044). The FEEDAP Panel concluded that the genetic modification of the production strain does not raise any safety concerns, and viable cells of the production strain and its DNA were not detected in the final products. The Panel also concluded that ECONASE® XT is safe for pigs for fattening, laying hens and minor poultry species at the proposed conditions of use. The use of the additive raises no safety concerns for the consumers of products derived from animals fed with the additive or for the environment. The liquid and solid forms of ECONASE® XT are non‐irritant to the skin, but only the liquid forms were confirmed as non‐irritant to the eyes and not dermal sensitisers. The Panel could not conclude on the irritation potential to the eyes and the dermal sensitisation potential for the solid forms. Due to the proteinaceous nature of the active substance, the additive is considered to be a respiratory sensitiser. The additive has the potential to be efficacious in pigs for fattening at 20,000 BXU/kg complete feed, in all laying poultry species at 12,000 BXU/kg complete feed and in minor poultry species other than laying birds at 8000 BXU/kg complete feed. [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product containing endo‐1,4‐β‐xylanase (ECONASE® XT) as a zootechnical feed additive (digestibility enhancer) for pigs for fattening, laying hens and minor poultry species. ECONASE® XT is available in two liquid and three solid forms and is produced with a genetically modified strain of Trichoderma reesei (CBS 114044). The FEEDAP Panel concluded that the genetic modification of the production strain does not raise any safety concerns, and viable cells of the production strain and its DNA were not detected in the final products. The Panel also concluded that ECONASE® XT is safe for pigs for fattening, laying hens and minor poultry species at the proposed conditions of use. The use of the additive raises no safety concerns for the consumers of products derived from animals fed with the additive or for the environment. The liquid and solid forms of ECONASE® XT are non‐irritant to the skin, but only the liquid forms were confirmed as non‐irritant to the eyes and not dermal sensitisers. The Panel could not conclude on the irritation potential to the eyes and the dermal sensitisation potential for the solid forms. Due to the proteinaceous nature of the active substance, the additive is considered to be a respiratory sensitiser. The additive has the potential to be efficacious in pigs for fattening at 20,000 BXU/kg complete feed, in all laying poultry species at 12,000 BXU/kg complete feed and in minor poultry species other than laying birds at 8000 BXU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ECONASE® XT (endo‐1,4‐β‐xylanase) produced by a genetically modified strain of Trichoderma reesei (CBS 140027) as a zootechnical feed additive for piglets (weaned), pigs for fattening, chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding and minor poultry species. The recipient strain and the production strain T. reesei CBS 140027 are considered safe. The additive is safe for chickens for fattening and weaned piglets at the maximum recommended doses (16,000 and 24,000 BXU/kg feed, respectively) with a wide margin of safety (100‐fold and 50‐fold, respectively). These conclusions are extended to chickens reared for laying and to pigs for fattening at 16,000 and 24,000 BXU/kg feed, respectively. The additive is safe for turkeys for fattening or reared for breeding at 16,000 BXU/kg feed. The FEEDAP Panel cannot conclude on the safety of the additive for laying hens and for minor poultry species for laying at the proposed conditions of use. The information provided does not allow to conclude on the safety of the use of ECONASE XT® P/L produced by T. reesei CBS 140027 in animal nutrition for the consumers. The use of the additive under assessment in animal nutrition does not raise safety concerns for the environment. ECONASE® XT L is non‐irritant to the skin or to the eyes. In absence of data, the FEEDAP Panel cannot conclude on the potential of the solid product to be irritant to skin and eyes and on the potential of the additive in all forms to be a dermal sensitiser. All forms of the additive should be considered as respiratory sensitisers. All forms of the additive are considered efficacious at the minimum recommended levels for the target species.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the ECONASE® XT, an enzyme based on endo‐1,4‐β‐xylanase produced by a genetically modified strain of Trichoderma reesei CBS 114044. The additive is currently authorised for use in chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding, minor poultry species, piglets (weaned) and pigs for fattening. ECONASE® XT is currently authorised in two forms, a solid and a liquid form with activities of 4,000,000 and 400,000 BXU/g, respectively. In a previous opinion, the FEEDAP Panel could not exclude the potential presence of recombinant DNA derived from the production organism in recent batches of the additive. The applicant has submitted data to support the absence of recombinant DNA derived from the production organism in recent product batches. The FEEDAP Panel confirms that the data provided support the absence of recombinant DNA of Trichoderma reesei CBS 114044 in the additive and thus, no safety concern was identified.

Abstract ECONASE® XT is an enzyme based on endo‐1,4‐β‐xylanase produced by a genetically modified strain of Trichoderma reesei ■■■■■. The additive is currently authorised for use in chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, laying hens, weaned piglets, pigs for fattening and minor poultry species. This scientific opinion concerns the renewal of the authorisation of the additive when used in weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. ECONASE® XT is currently authorised in two forms, a solid and a liquid form with activities of 4,000,000 and 400,000 BXU/g, respectively. The current application also comprises three new less concentrated formulations. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The Panel could not exclude the potential presence of recombinant DNA derived from the production organism in recent batches. However, since no sequences of concern have been introduced in the production strain, the potential presence of recombinant DNA in the final product does not raise any safety concern. No new evidence has been produced that would lead the Panel to reconsider its previous conclusions on the safety of the product for target species, consumers, users and the environment under the authorised conditions of use. Therefore, the FEEDAP Panel confirms that ECONASE® XT is safe for the target species, consumers of products from animals fed the additive and the environment. ECONASE® XT is non‐irritant to the skin, the liquid form is non‐irritant to the eyes and is not a dermal sensitiser, but the additive in all forms should be considered a potential respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.