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Commission Implementing Regulation (EU) No 361/2011 of 13 April 2011 concerning the authorisation of Enterococcus faecium NCIMB 10415 as a feed additive for chickens for fattening (holder of authorisation DSM Nutritional products Ltd represented by DSM Nutritional Products Sp. z o.o) and amending Regulation (EC) No 943/2005 Text with EEA relevance

Type Implementing Regulation

Publication 2011-04-14

Last updated 2015-04-16

State Repealed

Department European Commission

Source EUR-Lex

articles 4

Reform history JSON API

Article 1

The preparation specified in Annex I, 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

Annex I to Regulation (EC) No 943/2005 is replaced by the text in Annex II to this Regulation.

Article 3

Premixtures and compound feed containing Enterococcus faecium NCIMB 10415 labelled in accordance with Directive 70/524/EEC may continue to be placed on the market and used until stocks are exhausted.

Article 4

This Regulation shall enter into force on the 20th day following 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.

ANNEX I

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
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	CFU/kg of complete feedingstuff with a moisture content of 12 %	CFU/kg of complete feedingstuff with a moisture content of 12 %	Other provisions	End of period of authorisation
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	Category of zootechnical additives. Functional group: gut flora stabilisers	Category of zootechnical additives. Functional group: gut flora stabilisers	Category of zootechnical additives. Functional group: gut flora stabilisers	Category of zootechnical additives. Functional group: gut flora stabilisers	Category of zootechnical additives. Functional group: gut flora stabilisers	Category of zootechnical additives. Functional group: gut flora stabilisers	Category of zootechnical additives. Functional group: gut flora stabilisers	Category of zootechnical additives. Functional group: gut flora stabilisers	Category of zootechnical additives. Functional group: gut flora stabilisers	Category of zootechnical additives. Functional group: gut flora stabilisers
4b1705	DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o	Enterococcus faecium NCIMB 10415	Additive composition Preparation of Enterococcus faecium NCIMB 10415 containing a minimum of: coated form (with shellac): 2 × 10¹⁰ CFU/g of additive; Other microencapsulated forms: 1 × 10¹⁰ CFU/g additive Characterisation of the active substance Enterococcus faecium NCIMB 10415 Analytical method [^E0009] Enumeration: spread plate method using bile esculin azide agar Identification: Pulsed- Field Gel Electrophoresis (PFGE)	Chickens for fattening		3 × 10⁸	—	Other provisions	End of period of authorisation	1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. 2. The use is permitted in feed containing the authorised coccidiostats: decoquinate, monensin sodium, robenidine hydrochloride, diclazuril, semduramycin, lasalocid A sodium, maduramycin ammonium, narasin, narasin/nicarbazin or salinomycin sodium.	4 May 2021

Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/eurl-feed-additives

ANNEX II

Annex I to Regulation (EC) No 943/2005 is replaced by the following:

‘ANNEX I

EC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation

EC No Additive Chemical formula, description Species or category of animal Maximum age CFU/kg of complete feedingstuff CFU/kg of complete feedingstuff Other provisions End of period of authorisation

EC No Additive Chemical formula, description Species or category of animal Maximum age Micro-organisms Micro-organisms Micro-organisms Micro-organisms Micro-organisms Micro-organisms Micro-organisms Micro-organisms Micro-organisms Micro-organisms

E 1705 Enterococcus faecium NCIMB 10415 Preparation of Enterococcus faecium containing a minimum of: Microencapsulated form: 1,0 × 10¹⁰ CFU/g of additive; Granulated form: 3,5 × 10¹⁰ CFU/g additive Pigs for fattening — 0,35 × 10⁹ 1,0 × 10⁹ Other provisions End of period of authorisation In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Without a time limit’

EC No	Additive	Chemical formula, description	Species or category of animal	Maximum age	Minimum content	Maximum content	Other provisions	End of period of authorisation
EC No	Additive	Chemical formula, description	Species or category of animal	Maximum age	CFU/kg of complete feedingstuff	CFU/kg of complete feedingstuff	Other provisions	End of period of authorisation
EC No	Additive	Chemical formula, description	Species or category of animal	Maximum age	Micro-organisms	Micro-organisms	Micro-organisms	Micro-organisms	Micro-organisms	Micro-organisms	Micro-organisms	Micro-organisms	Micro-organisms	Micro-organisms
E 1705	Enterococcus faecium NCIMB 10415	Preparation of Enterococcus faecium containing a minimum of: Microencapsulated form: 1,0 × 10¹⁰ CFU/g of additive; Granulated form: 3,5 × 10¹⁰ CFU/g additive	Pigs for fattening	—	0,35 × 10⁹	1,0 × 10⁹	Other provisions	End of period of authorisation	In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.	Without a time limit’

OJ L 268, 18.10.2003, p. 29.

OJ L 270, 14.12.1970, p. 1.

OJ L 243, 15.7.2004, p. 10.

OJ L 159, 22.6.2005, p. 6.

OJ L 195, 27.7.2005, p. 6.

OJ L 44, 15.2.2006, p. 3.

OJ L 34, 4.2.2009, p. 8.

[^E0008]: (⁸) EFSA Journal 2010; 8(7):1661.

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