Commission Implementing Regulation (EU) 2021/1424 of 31 August 2021 concerning the renewal of the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for chickens for fattening, and repealing Regulation (EU) No 998/2010 (holder of authorisation Lactosan GmbH & Co KG) (Text with EEA relevance)
Commission Implementing Regulation (EU) 2021/1424of 31 August 2021concerning the renewal of the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for chickens for fattening, and repealing Regulation (EU) No 998/2010 (holder of authorisation Lactosan GmbH & Co KG)(Text with EEA relevance) 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 nutritionOJ L 268, 18.10.2003, p. 29., 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 and renewing such authorisation.(2)The preparation of Enterococcus faecium DSM 7134 was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EU) No 998/2010Commission Regulation (EU) No 998/2010 of 5 November 2010 concerning the authorisation of Enterococcus faecium DSM 7134 as a feed additive for chickens for fattening (holder of the authorisation Lactosan GmbH & Co KG) (OJ L 290, 6.11.2010, p. 22)..(3)In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of the preparation of Enterococcus faecium DSM 7134 as a feed additive for chickens for fattening, requesting the additive to be classified in the additive category "zootechnical additives". That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 27 January 2021EFSA Journal 2021;19(3):6451. that the applicant had provided evidence that the additive complies with the existing conditions of authorisation. The Authority further concluded that the preparation of Enterococcus faecium DSM 7134 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the preparation is not irritant to skin and eyes, but it should be considered a potential skin sensitiser and a respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also verified the report on the methods 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 the preparation of Enterococcus faecium DSM 7134 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed.(6)As a consequence of the renewal of the authorisation of the preparation of Enterococcus faecium DSM 7134 as a feed additive, Regulation (EU) No 998/2010 should be repealed.(7)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,HAS ADOPTED THIS REGULATION:
Article 1The authorisation of the preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "gut flora stabilisers", is renewed subject to the conditions laid down in that Annex.
Article 2Regulation (EU) No 998/2010 is repealed.
Article 3This 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 August 2021.For the CommissionThe PresidentUrsula von der LeyenANNEX
Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %
Category of zootechnical additivesFunctional group: gut flora stabilisers
4b1841Lactosan GmbH & Co KGEnterococcus faecium DSM 7134Additive compositionPreparation of Enterococcus faeciumDSM 7134containing a minimum of:Powder: 1 × 1010 CFU/g of additiveGranules (microencapsulated): 1x1010CFU/g of additiveChickens for fattening-5 × 108-1.In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2.May be used in feed containing the following permitted coccidiostats: robenidine hydrochloride, maduramicin ammonium, diclazuril, decoquinate, halofuginone hydrobromide, monensin sodium and lasalocid A sodium.3.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing and skin protection.21 September 2031
Characterisation of the active substanceViable cells of Enterococcus faecium DSM 7134
Analytical methodFor enumeration: Spread plate method using bile esculin azid agar (EN 15788).For identification: Pulsed Field Gel Electrophoresis (PFGE).