Commission Implementing Regulation (EU) No 1077/2013

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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition^note, and in particular Article 9(2) thereof,Whereas:

(1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for 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. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)That application concerns 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, to be classified in the additive category ‘zootechnical additives’.

(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 March 2013^note that, under the proposed conditions of use, the 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 does not have an adverse effect on animal health, human health or the environment. The Authority recognised that it has the potential to increase the body weight in suckling piglets. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)The assessment of that preparation shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

(6)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

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.

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 %
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 compositionPreparation 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), andStreptococcus 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 formCharacterisation of the active substanceViable cells of: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 8253Analytical methodEnumeration 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, andStreptococcus 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

Commission Implementing Regulation (EU) No 1077/2013

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