6-phytase from Aspergillus oryzae DSM 33737 extended to laying poultry, piglets and pigs for fattening: activity determined colorimetrically according to EN ISO 30024, minimum 200 FYT/kg, while efficacy trials were run at 187.5 FYT/kg
Commission Implementing Regulation (EU) 2026/1013, published on 8 May 2026, authorises until 28 May 2036 a preparation of 6-phytase (EC 3.1.3.26) produced with Aspergillus oryzae DSM 33737 (holder Novozymes A/S) as a digestibility enhancer for laying or breeding poultry, piglets and Suidae for fattening or reared for reproduction. The same preparation was already authorised in 2024 for poultry for fattening and reared, sows and fish; now EFSA, on the basis of new trials, considered it potentially efficacious in all poultry and porcine species.
- Method and specification: phytase activity in the additive, premixtures and compound feed is determined by a colorimetric method based on the enzymatic reaction of phytase with phytate — EN ISO 30024. One FYT is the amount of enzyme that releases 1 µmol of inorganic phosphate per minute from sodium phytate at 37 °C and pH 5.5. Minimum activity of the preparation: solid form 10 000 FYT/g, liquid form 20 000 FYT/g; according to EFSA the additive comes in two solid and two liquid formulations with 10 000–50 000 FYT/g.
- The minimum content for all new categories is 200 FYT/kg complete feed, with no maximum. The applicant proposed a minimum of 187.5 FYT/kg and ran its trials at that dose; EFSA framed its efficacy conclusion at the minimum recommended level of 200 FYT/kg.
- Trials in the 2025 EFSA opinion: 768 Novogen Brown laying hens for 113 days — at 187.5 FYT/kg a higher laying rate (93.6 vs 92.1 %) and final body weight, slightly lower egg weight with unchanged daily egg mass; in 20 weaned piglets in metabolic cages phosphorus retention 43.0 % vs 31.8 % in the control group. A long-term piglet trial was rejected because the control piglets grew below 300 g/day and 25 % of the animals were removed; an earlier one because copper in the feed exceeded EU limits.
- User safety according to the act and the 2024 opinion: no formulation is a skin irritant, the two liquid ones are not eye irritants, the two solid ones are eye irritants, no conclusion could be drawn on skin sensitisation, and as a protein the enzyme is a respiratory sensitiser, although inhalation exposure is unlikely; eye protection is required only for the solid forms. The summary of the 2025 opinion quotes these conclusions differently (not a skin and eye irritant, a skin and respiratory sensitiser).