Commission Implementing Regulation (EU) No 1077/2013 of 31 October 2013 concerning the authorisation of a preparation 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 as a feed additive for suckling piglets (holder of authorisation Lactina Ltd) Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 1077/2013
• Articles: 3

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.

Schedules & Appendices

ANNEX

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 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

Additive composition

Preparation of:

Enterococcus faecium NBIMCC 8270 (minimum of 1,4 × 10 9  CFU/g of additive),

Lactobacillus acidophilus NBIMCC 8242 (minimum of 8 × 10 8  CFU/g of additive), Lactobacillus helveticus NBIMCC 8269 (minimum of 5 × 10 8  CFU/g of additive), Lactobacillus delbrueckii ssp. lactis NBIMCC 8250 (minimum of 2 × 10 8  CFU/g of additive), Lactobacillus delbrueckii ssp. bulgaricus NBIMCC 8244 (minimum of 3 × 10 8  CFU/g of additive), and

Streptococcus thermophilus NBIMCC 8253 (minimum of 1,8 × 10 9  CFU/g of additive) containing a minimum of 5 × 10 9  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

( 1 )

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 × 10 9

—

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

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx