Pediococcus pentosaceus DSM 32292

Executive Summary

In the current application authorisation is sought under Article 4 for Pediococcus pentosaceus DSM 32292 under the category/functional group 1(k) "technological additives"/"silage additives", according to Annex I of Regulation (EC) No 1831/2003. Specifically, the authorisation is sought for the use of the feed additive in silage for all animal species.
According to the Applicant, the feed additive contains as active substance viable cells of the strain Pediococcus DSM 32292. The feed additive is to be marketed as preparation with a minimum content of 1x1010 Colony Forming Units (CFU) of Pediococcus pentosaceus DSM 32292 /g feed additive. The feed additive is intended to be used at a minimum dose of 5x107 CFU/kg silage.
For the identification of Pediococcus pentosaceus DSM 32292, the EURL recommends for official control (i) Whole Genome Sequencing Analysis (WGS) or (ii) Pulsed-Field Gel Electrophoresis (PFGE). The EURL considers that both methodologies are fit for purpose for the bacterial identification of authorised additives at a strain level.
For the enumeration of Pediococcus DSM 32292 in the feed additive, the EURL recommends for official control the ring-trial validated spread plate method EN 15786.
Since the unambiguous determination of the content of DSM 32292 initially added to silage is not achievable by analysis, the EURL cannot evaluate nor recommend any method for official control for the determination of Pediococcus pentosaceus DSM 32292 in silage.
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.