Preparation of Bacillus licheniformis DSM 33806 and Weizmannia faecalis DSM 32016

In the current application an authorisation is sought under Article 4(1) for a preparation of Bacillus licheniformis DSM 33806 and Weizmannia faecalis DSM 32016 under the category / functional group 4(b) 'zootechnical additives' / 'gut flora stabilizers', according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for piglets (suckling and weaned), pigs for fattening, sows and physiologically related minor growing and reproductive porcine species.
According to the Applicant, the product is a preparation containing viable spores of Bacillus licheniformis DSM 33806 and Weizmannia faecalis DSM 32016 at a minimum amount of 2.4 x 10¹⁰ and 6.0 x 10⁹ Colony Forming Unit (CFU) / g feed additive, respectively. The feed additive is intended to be added to compound feed and water at a recommended dosage of 1.5 x 10⁹ CFU / kg feed and 0.75 x 10⁹ CFU / l water, respectively.
For the enumeration of Bacillus licheniformis DSM 33806 in the feed additive, premixtures and compound feed the Applicant proposed for official control the ring-trial validated spread plate method EN 15784 as recently revised by CEN (equivalent to VDLUFA method 28.2.2). The Applicant did not recommend any method for the enumeration of the feed additive in water. However, in the frame of the stability studies supporting the dossier, the Applicant presented experimental results applying the VDLUFA method 28.2.2 for the enumeration of Bacillus licheniformis in water thus demonstrating its applicability also to this matrix. Based on the performance characteristics and the further experimental evidences presented within the dossier, the EURL recommends for official control the ring-trial validated EN 15784 method for the enumeration of Bacillus licheniformis DSM 33806 in the feed additive, premixtures, compound feed and water.
For the enumeration of Weizmannia faecalis DSM 32016 in the feed additive, premixtures and compound feed the Applicant proposed for official control a slightly modified method based on the ring-trial validated spread plate method EN 15787 dedicated for the analysis of Lactobacillus spp.. The method was formerly presented and positively evaluated by the EURL in the frame of a previous Weizmannia faecalis currently authorised by Commission Implementing Regulation (EU) 2020/1755. The Applicant did not recommend any method for the enumeration of the feed additive in water. However, in the frame of stability studies the Applicant presented experimental results applying the modified EN 15787 for the enumeration of Weizmannia faecalis DSM 32016 in water thus demonstrating its applicability also to this matrix. Based on the performance characteristics and the experimental data available, the EURL recommends for the official control the modified method based on ring-trial validated method EN 15787 for the enumeration of Weizmannia faecalis DSM 32016 in the feed additive, premixtures, compound feed and water. For the identification of Bacillus licheniformis DSM 33806 and Weizmannia faecalis DSM 32016 at a strain level, the EURL recommends for official control DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE) (CEN/TS 17697).
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.