Safety and efficacy of Axtra® XAP 104 TPT (endo‐1,4‐xylanase, protease and alpha‐amylase) as a feed additive for chickens for fattening, laying hens and minor poultry species

Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Axtra ® XAP 104 TPT as a zootechnical feed additive (digestibility enhancers) for poultry species. The additive contains three enzyme activities (endo-1,4-beta-xylanase, protease and alphaamylase) produced by three different genetically modified strains. Viable cells and recombinant DNA of the strains producing the protease and amylase were not detected in the final product. Owing to the insufficient data, uncertainty remained on the presence in the additive of viable cells of the strain producing the xylanase. The results obtained in the genotoxicity and subchronic oral toxicity studies performed with the three fermentation products did not indicate safety concerns resulting from the fermentation products used in the formulation/manufacturing. However, uncertainties remain on the suitability of the test item used in the studies conducted with the xylanase; therefore, the Panel was not in the position to conclude on the toxicological potential of AXTRA ® XAP 104 TPT. Consequently, the Panel could not conclude on the safety of the additive for the target species, consumers and users. Owing to the uncertainty on the presence of viable cells of one of the production strains in the additive, the Panel could not conclude on the safety for the environment. The FEEDAP Panel concluded that AXTRA ® XAP 104 TPT is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay at the level of 2,000 U xylanase, 200 U amylase and 4,000 U protease per kg feed. Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens.

Safety and efficacy of a feed 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) for chickens for fattening, laying hens and minor poultry species (Genencor international B.V.)

“…The FEEDAP Panel adopted a scientific opinion on the safety and efficacy of the additive (EFSA FEEDAP Panel, 2020 ). The product assessed at that time contained endo‐1,4‐beta‐xylanase produced by a genetically modified strain of T. reesei (ATCC PTA‐5588); protease produced by a genetically modified strain of B. subtilis (ATCC SD‐2107); and alpha‐amylase produced by a genetically modified strain of B. licheniformis (ATCC SD‐6525).…”

“…In that assessment, the FEEDAP Panel identified a series of shortcomings which did not allow for conclusions regarding the safety of the product, including (i) uncertainty on the presence of viable cells of the genetically modified strain T. reesei ATCC PTA‐5588; (ii) uncertainty about the identity and presence in the final additive of the production strains of the ■■■■■ used in the manufacturing process of the protease, and (iii) uncertainty about the test item used for the toxicological testing of the xylanase. The Panel also could not conclude on the efficacy of the additive in laying hens (EFSA FEEDAP Panel, 2020 ).…”

“…For the protease, the applicant declared the change in the production strain. The B. subtilis ATCC SD‐2107 described in the previous opinion (EFSA FEEDAP Panel, 2020 ) has been replace by B. subtilis CBS 148232. The newly declared strain requires full characterisation.…”

“…The applicant declared, in the previous assessment, the use of a mixture of ■■■■■ in the manufacturing process of the protease (EFSA FEEDAP Panel, 2020 ). Uncertainty remained about the identity of the strains used for the production of the ■■■■■.…”

“…The FEEDAP Panel adopted an opinion on this product in 2020 (EFSA FEEDAP Panel, 2020 ). In the context of the current assessment, the applicant has changed the production strain of the protease, substituting strain ATCC SD‐2107 of B. subtilis for strain CBS 148232 of the same species.…”