Preparation of lactic acid bacteria

In the current application an authorisation is sought under Article 4(1) for a preparation of Lactobacillus acidophilus CNCM I-3231, Ligilactobacillus salivarius CNCM I-3233, Lacticaseibacillus paracasei CNCM I-4901, Bifidobacterium longum CNCM I-3227, Bifidobacterium animalis subsp. lactis CNCM I-3993 under the category 'zootechnical additives', functional groups (b) 'gut flora stabilizers' and (d) "other zootechnical additives", according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for cats and other non-food-producing animals.
According to the Applicant, the feed additive is a preparation containing several strains of lactic acid bacteria as active substances, namely Lactobacillus acidophilus CNCM I-3231, Ligilactobacillus salivarius CNCM I-3233, Lacticaseibacillus paracasei CNCM I-4901, Bifidobacterium longum CNCM I-3227, Bifidobacterium animalis subsp. lactis CNCM I-3993 with a minimum total content of 3 x10¹⁰ Colony Forming Units (CFU) / g feed additive.
The feed additive is intended to be added directly into compound feed (including complementary feed) at a minimum dose of total content of the active substances of 2 x 10¹¹ CFU / kg compound feed. The feed additive is not intended to be used in premixtures.
For the identification of Lactobacillus acidophilus CNCM I-3231, Ligilactobacillus salivarius CNCM I-3233, Lacticaseibacillus paracasei CNCM I-4901, Bifidobacterium longum CNCM I-3227, Bifidobacterium animalis subsp. lactis CNCM I-3993 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 total lactic acid bacteria: Lactobacillus acidophilus CNCM I-3231, Ligilactobacillus salivarius CNCM I-3233, Lacticaseibacillus paracasei CNCM I-4901, Bifidobacterium longum CNCM I-3227, Bifidobacterium animalis subsp. lactis CNCM I-3993 in the feed additive and compound feed, the Applicant proposed and submitted the horizontal ISO 15214 standard method (spread or pour plated method on MRS agar) dedicated for the enumeration of mesophilic lactic acid bacteria in food and animal feedingstuffs.
The above-mentioned method was applied in the frame of batch-to-batch analysis of the feed additive, in stability, homogeneity and verification/method comparison studies for the enumeration of total lactic acid bacteria carried out in the feed additive and compound feed.
Based on the performance characteristics and experimental data available, the EURL recommends for official control the spread (or pour) plate method on MRS agar (ISO 15214) for the enumeration of total lactic acid bacteria: Lactobacillus acidophilus CNCM I-3231, Ligilactobacillus salivarius CNCM I-3233, Lacticaseibacillus paracasei CNCM I-4901, Bifidobacterium longum CNCM I-3227, Bifidobacterium animalis subsp. lactis CNCM I-3993 in the feed additive and compound feed.
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.