Xylanase, subtilisin and alpha-amylase (Avizyme® 1505, 4a10) renewed and extended to all poultry: three colorimetric methods with azurine-crosslinked substrates, for turkeys for fattening the dose lowered from 300/4 000/400 to 187.5/2 500/250 U/kg
Commission Implementing Regulation (EU) 2025/193, published on 3 February 2025, renews until 23 February 2035 the authorisation of the preparation of endo-1,4-beta-xylanase (Trichoderma reesei CBS 143953), subtilisin (Bacillus subtilis CBS 143946) and alpha-amylase (Bacillus amyloliquefaciens CBS 143954) for chickens for fattening, turkeys for fattening, ducks and laying hens, authorises it for the other poultry (holder Genencor International B.V.) and repeals Regulations (EC) No 1087/2009 and (EU) No 389/2011.
- Specification (annex, zootechnical additive — digestibility enhancers): minimum activity of xylanase 1 500 U/g, subtilisin 20 000 U/g, alpha-amylase 2 000 U/g; solid form. The strains were previously deposited in ATCC as PTA 5588, 2107 and 3978 (recital 2). Minimum doses per kg of complete feed (12 % moisture): ducks 75 U xylanase, 1 000 U subtilisin, 100 U amylase; poultry for fattening, reared for breeding and reared for laying (except ducks) 187.5/2 500/250 U; laying poultry (except ducks) 300/4 000/400 U. The applicant asked for the dose for turkeys for fattening to be lowered from 300/4 000/400 to 187.5/2 500/250 U (recital 3).
- Methods: all three activities in the additive, premixtures and feed are determined colorimetrically by measuring the water-soluble dye released by the enzyme from a commercial azurine-crosslinked substrate — wheat arabinoxylan (xylanase), casein (subtilisin) and starch polymer (amylase). Unit definitions: 1 U of xylanase releases 0.48 μmol of reducing sugars (xylose equivalent) from wheat arabinoxylan per minute at pH 4.2 and 50 °C; 1 U of subtilisin — 1 μmol of phenolic compounds (tyrosine equivalent) from casein at pH 7.5 and 40 °C; 1 U of amylase — 1 μmol of glucosidic linkages from an insoluble starch substrate at pH 6.5 and 37 °C.
- Safety (recital 5, e8797): the additive is safe for the target animals, consumers and the environment, mildly irritant to skin and eyes, not a skin sensitiser but a respiratory sensitiser — hence protection of the respiratory tract, eyes and skin. EFSA: no viable cells or DNA of the production strains were detected in the intermediate products; new data confirmed the identity of B. subtilis CBS 143946 (phylogenomic analysis of 446 core proteins) and B. amyloliquefaciens CBS 143954 (465 proteins), for the latter a putative clbA gene that may confer chloramphenicol resistance was among the genome findings (the susceptibility profile was assessed in 2020, the result is blacked out in the published opinion); for the T. reesei strain the ability to produce trichothecenes and gliotoxin was tested — none were detected in the culture of an intermediate strain.
- Efficacy (e8797): since the composition and conditions of use have not changed and the applicant showed that the proposed xylanase unit definition is valid for the product, the Panel maintained the efficacy concluded in the 2020 assessment at all three doses. Transitional period: the additive and premixtures labelled before 23 August 2025, and feed labelled before 23 February 2026, may be used until stocks are exhausted.