Weizmannia faecalis DSM 32016 (TechnoSpore® 50)

In the current application an authorisation is sought under Article 4(1) for Weizmannia faecalis DSM 32016 under the category / functional group 4(b) 'zootechnical additives' / 'gut flora stabilisers', according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for calves and other bovines, ovines, caprines, cervids and camelids at the corresponding developmental stage.
According to the Applicant, the feed additive contains viable spores of the non-genetically modified strain of Weizmannia faecalis DSM 32016 as an active substance. The feed additive is to be marketed as a powder (under the trade name - TechnoSpore^® 50) containing a minimum content of the active substance of 2x10¹⁰ Colony Forming Unit (CFU)/g TechnoSpore^® 50. The feed additive is intended to be used in compound feed, premixtures and water for drinking at a minimum dose of 1x10⁹ CFU/kg compound feed and 5x10⁸ CFU/l water.
For the identification of Weizmannia faecalis DSM 32016 at strain level, the EURL recommends for official control Pulsed-Field Gel Electrophoresis (PFGE) (CEN/TS 17697) or DNA sequencing methods.
For the enumeration of Weizmannia faecalis DSM 32016 in the feed additive, premixtures, compound feed and water, the Applicant proposed a slightly modified method based on ring-trial validated spread plate method EN 15787 already submitted and evaluated by the EURL in the frame of a previous dossier from the same Applicant which have been recently published as the ring-trial validated VDLUFA 28.2.7 method. Based on the performance characteristics and experimental data available, the EURL recommends the VDLUFA 28.2.7 for the official control for the enumeration of Weizmannia faecalis DSM 32016 in the feed additive, premixtures, compound feed and water.
Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.