02017R0961 — EN — 26.05.2021 — 001.001

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►B COMMISSION IMPLEMENTING REGULATION (EU) 2017/961 of 7 June 2017 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as a feed additive for weaned piglets, and a new use in water for drinking for weaned piglets and chickens for fattening, and amending Regulation (EC) No 2036/2005 and Regulation (EU) No 887/2011 ( ►M1 holder of the authorisation Evonik Operations GmbH ◄ ) (Text with EEA relevance) (OJ L 145 8.6.2017, p. 7)

Amended by:









▼B

COMMISSION IMPLEMENTING REGULATION (EU) 2017/961

of 7 June 2017

concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as a feed additive for weaned piglets, and a new use in water for drinking for weaned piglets and chickens for fattening, and amending Regulation (EC) No 2036/2005 and Regulation (EU) No 887/2011 ( ►M1 holder of the authorisation Evonik Operations GmbH ◄ )

(Text with EEA relevance)







Article 1

Authorisation

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

Amendment to Regulation (EC) No 2036/2005

In Annex I to Regulation (EC) No 2036/2005, the entry E 1713 on Enterococcus faecium CECT 4515 is deleted.

Article 3

Amendment to Regulation (EU) No 887/2011

The Annex to Regulation (EU) No 887/2011 is replaced by Annex II to this Regulation.

Article 4

Transitional measures

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 28 December 2017 in accordance with the rules applicable before 28 June 2017 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 5

Entry into force

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.









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 Minimum content Maximum content Other provisions End of period of authorisation CFU/kg of complete feedingstuff with a moisture content of 12 % CFU/l of water for drinking Category of zootechnical additives. Functional group: gut flora stabilisers 4b1713 ►M1 Evonik Operations GmbH ◄ ) Enterococcus faecium CECT 4515 Additive composition Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive in solid form Characterisation of the active substance Viable cells of Enterococcus faecium CECT 4515 Analytical method (1) Enumeration: spread plate method using bile esculin azide agar (EN 15788) Identification: Pulsed-Field Gel Electrophoresis (PFGE) Weaned piglets 1 × 109 — 5 × 108 — 1. The additive may be used in water for drinking. 2. In the directions for use of the additive and premixtures stability in water for drinking shall be indicated. 3. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 4. For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured. 5. For use in weaned piglets up to 35 kg of body weight. 6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 protection and skin protection. 28 June 2027 ( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports









ANNEX II









‘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 4b1713 ►M1 Evonik Operations GmbH ◄ ) Enterococcus faecium CECT 4515 Additive composition Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive Solid forms Characterisation of the active substance Viable cells of Enterococcus faecium CECT 4515 Analytical method (1) Enumeration: spread plate method using bile esculin azide agar (EN 15788) Identification: Pulsed-Field Gel Electrophoresis (PFGE) Chickens for fattening — 1 × 109 — 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. The use is compatible in feed containing one of the following authorised coccidiostats: monensin sodium, diclazuril, nicarbazin, decoquinate, robenidine hydrochloride, semduramycin sodium, narasin, salinomicin sodium, lasalocid A sodium, narasin/nicarbazin or maduramycin ammonium. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 protection and skin protection. 26 September 2021 ( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports