
Article 1 
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 31 October 2013.
For the Commission
The President
José Manuel BARROSO
ANNEX

Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1891 Lactina Ltd Enterococcus faecium NBIMCC 8270Lactobacillus acidophilus NBIMCC 8242, Lactobacillus helveticus NBIMCC 8269,Lactobacillus delbrueckii ssp. lactis NBIMCC 8250, Lactobacillus delbrueckii ssp. bulgaricus NBIMCC 8244,andStreptococcus thermophilus NBIMCC 8253 
 Additive composition
Preparation of:

 Enterococcus faecium NBIMCC 8270 (minimum of 1,4 × 109 CFU/g of additive),
 Lactobacillus acidophilus NBIMCC 8242 (minimum of 8 × 108 CFU/g of additive), Lactobacillus helveticus NBIMCC 8269 (minimum of 5 × 108 CFU/g of additive), Lactobacillus delbrueckii ssp. lactis NBIMCC 8250 (minimum of 2 × 108 CFU/g of additive), Lactobacillus delbrueckii ssp. bulgaricus NBIMCC 8244 (minimum of 3 × 108 CFU/g of additive), and
 Streptococcus thermophilus NBIMCC 8253 (minimum of 1,8 × 109 CFU/g of additive) containing a minimum of 5 × 109 CFU/g of additive (total amount)Solid form
 Characterisation of the active substance
Viable cells of:
 Enterococcus faecium NBIMCC 8270
 Lactobacillus acidophilus NBIMCC 8242, Lactobacillus helveticus NBIMCC 8269, Lactobacillus delbrueckii ssp. lactis NBIMCC 8250, Lactobacillus delbrueckii ssp. bulgaricus NBIMCC 8244, and
 Streptococcus thermophilus NBIMCC 8253
 Analytical method
Enumeration of:
 Enterococcus faecium NBIMCC 8270,
 Lactobacillus acidophilus NBIMCC 8242, Lactobacillus helveticus NBIMCC 8269, Lactobacillus delbrueckii ssp. lactis NBIMCC 8250, Lactobacillus delbrueckii ssp. bulgaricus NBIMCC 8244 and Streptococcus thermophilus NBIMCC 8253: Spread plate method (EN 15787).
 Identification of Enterococcus faecium NBIMCC 8270, Lactobacillus acidophilus NBIMCC 8242, Lactobacillus helveticus NBIMCC 8269, Lactobacillus delbrueckii ssp. lactis NBIMCC 8250, Lactobacillus delbrueckii ssp. bulgaricus NBIMCC 8244, and
 Streptococcus thermophilus NBIMCC 8253: Pulsed Field Gel Electrophoresis (PFGE). Suckling piglets — 5 × 109 — 
1.. In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.
2.. For suckling piglets up to 35 days.
3.. For safety: it is recommended to use breathing protection and gloves during handling. 21 November 2023
