NS AH007

Executive Summary

In the current application an authorisation is sought under Article 4(1) for NS AH007 under the category / functional groups 1(a & j) 'Technological additives' / ‘preservatives’ & ‘acidity regulators', according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for chickens for fattening and chickens reared for laying.
According to the Applicant, the feed additive contains as active substances viable spores of the non-genetically modified strain Bacillus velezensis NRRL-B-50910, and viable cells of the non-genetically modified strains Pediococcus acidilactici NRRL-B-50959 and Pediococcus acidilactici NRRL-B-50964. The feed additive is to be marketed as a powder containing a minimum content of Bacillus velezensis NRRL-B-50910 of 3x1010 Colony Forming Unit (CFU) / g and of total Pediococcus acidilactici (sum of the two strains) of 1x1010 CFU / g. The feed additive is intended to be used in feedingstuffs at a minimum dose of total active substances (sum of the three strains) of 4 x 108 CFU / g complete feedingstuffs.
For the identification of Bacillus velezensis NRRL-B-50910, Pediococcus acidilactici NRRL-B-50959 and Pediococcus acidilactici NRRL-B-50964, the EURL recommends for the official control Pulsed Field Gel Electrophoresis (PFGE), a generally recognised methodology for the genetic identification of bacterial strains.
For the enumeration of Bacillus velezensis NRRL-B-50910 in the feed additive, the Applicant submitted the ring-trial validated spread plate CEN method EN 15784. For the enumeration of total Pediococcus acidilactici NRRL-B-50959 and Pediococcus acidilactici NRRL-B-50964 in the feed additive, the Applicant submitted the ISO 15214 method which is not ring trial validated but it is similar to the ring trial validated spread plate method EN 15786 using acidified MRS agar (AMRSA).
The Applicant did not provide any method or experimental data for the quantification of the total active substances in feedingstuffs. Both CEN methods previously mentioned, EN 15784 and EN 15786 using AMRSA, were however also ring trial validated for the enumeration of respectively Bacillus spp. and Pedioccocus spp. in feedingstuffs.
Based on the performance characteristics and the experimental data available, the EURL recommends for the official control the EN 15784 spread plate method for the enumeration of Bacillus velezensis NRRL-B-50910 in the feed additive and feedingstuffs and the EN 15786 spread plate method using AMRSA or the ISO 15214 method for the enumeration of total Pediococcus acidilactici NRRL-B-50959 and Pediococcus acidilactici NRRL-B-50964 in the feed additive and feedingstuffs.

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.