- 23 Oktober 2015 (Senest opdateret den: 6 Juni 2016)
Enumeration in the feed additive:
- spread plate method on MRS agar (EN 15787)
Identification of the feed additive:
- Pulsed Field Gel Electrophoresis (PFGE)
In the current application authorisation is sought under Article 4(1) for Lactobacillus plantarum TAK 59 NCIMB 42150 under the category / functional group 1(k) 'technological additives' / 'silage additives', according to Annex I of Regulation (EC) No 1831/2003. Authorization is sought for the use of the feed additive for all animal species. According to the Applicant, the feed additive contains as active substance viable cells of the non-genetically modified strain Lactobacillus plantarum TAK 59 NCIMB 42150. The feed additive is to be marketed as a powder containing a minimum Lactobacillus plantarum TAK 59 NCIMB 42150 concentration of 1x1011 Colony Forming Unit (CFU)/g. The feed additive is intended to be added to silage at a minimum dose of 1x105 CFU/g fresh silage. For the identification of Lactobacillus plantarum TAK 59 NCIMB 42150, the EURL recommends for official control Pulsed Field Gel Electrophoresis (PFGE), a generally recognised standard methodology for genetic identification. This standard methodology for microbial identification is currently being evaluated by the CEN Technical Committee 327 to become a European Standard. For enumeration of Lactobacillus plantarum TAK 59 NCIMB 42150, the Applicant submitted the ring-trial validated spread plate method EN 15787 which was already evaluated by EURL in the frame of previous Lactobacillus plantarum dossiers. Based on the performance characteristics available, the EURL recommends for official control this ring-trial validated EN 15787 method for the enumeration of Lactobacillus plantarum TAK 59 NCIMB 42150 in the feed additive per se. The Applicant did not provide any experimental method or data for the determination of Lactobacillus plantarum TAK 59 NCIMB 42150 in silage. Furthermore, the unambiguous determination of the content of Lactobacillus plantarum TAK 59 NCIMB 42150 added to silage is not achievable by analysis. Therefore, the EURL cannot evaluate nor recommend any method for official control to determine Lactobacillus plantarum TAK 59 NCIMB 42150 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) is not considered necessary.