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 (holder of authorisation Evonik Nutrition & Care GmbH) (Text with EEA relevance. )
Modified by
  • Commission Implementing Regulation (EU) 2021/733of 5 May 2021amending Implementing Regulation (EU) No 887/2011 and Implementing Regulation (EU) 2017/961 as regards the name of the holder of the authorisation of Enterococcus faecium CECT 4515 as a feed additive and amending Implementing Regulation (EU) 2020/1395 as regards the name of the holder of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive(Text with EEA relevance), 32021R0733, May 6, 2021
Commission Implementing Regulation (EU) 2017/961of 7 June 2017concerning 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 (holder of the authorisation Evonik Operations GmbH)(Text with EEA relevance)
Article 1AuthorisationThe 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 2Amendment to Regulation (EC) No 2036/2005In Annex I to Regulation (EC) No 2036/2005, the entry E 1713 on Enterococcus faecium CECT 4515 is deleted.
Article 3Amendment to Regulation (EU) No 887/2011The Annex to Regulation (EU) No 887/2011 is replaced by Annex II to this Regulation.
Article 4Transitional measuresThe 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 5Entry into forceThis 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
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-reportsCategory of zootechnical additives. Functional group: gut flora stabilisers
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %CFU/l of water for drinking
4b1713Evonik Operations GmbH)Enterococcus faeciumCECT 4515Additive compositionPreparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive in solid formCharacterisation of the active substanceViable cells of Enterococcus faecium CECT 4515Analytical methodEnumeration: spread plate method using bile esculin azide agar (EN 15788)Identification: Pulsed-Field Gel Electrophoresis (PFGE)Weaned piglets1 × 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
ANNEX II"ANNEX
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-reportsCategory of zootechnical additives. Functional group: gut flora stabilisers
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 %
4b1713Evonik Operations GmbH)Enterococcus faeciumCECT 4515Additive compositionPreparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additiveSolid formsCharacterisation of the active substanceViable cells of Enterococcus faecium CECT 4515Analytical methodEnumeration: 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
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-reportsCategory of zootechnical additives. Functional group: gut flora stabilisers
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/l of water for drinking
4b1713Evonik Operations GmbH)Enterococcus faeciumCECT 4515Additive compositionPreparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additiveSolid forms.Characterisation of the active substanceViable cells of Enterococcus faecium CECT 4515Analytical methodEnumeration: spread plate method using bile esculin azide agar (EN 15788)Identification: Pulsed- Field Gel Electrophoresis (PFGE)Chickens for fattening—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.For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.4.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.5.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"
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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-reportsDetails 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
Article 1AuthorisationThe 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 2Amendment to Regulation (EC) No 2036/2005In Annex I to Regulation (EC) No 2036/2005, the entry E 1713 on Enterococcus faecium CECT 4515 is deleted.
Article 3Amendment to Regulation (EU) No 887/2011The Annex to Regulation (EU) No 887/2011 is replaced by Annex II to this Regulation.
Article 4Transitional measuresThe 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 5Entry into forceThis 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
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-reportsCategory of zootechnical additives. Functional group: gut flora stabilisers
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %CFU/l of water for drinking
4b1713Evonik Operations GmbH)Enterococcus faeciumCECT 4515Additive compositionPreparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive in solid formCharacterisation of the active substanceViable cells of Enterococcus faecium CECT 4515Analytical methodEnumeration: spread plate method using bile esculin azide agar (EN 15788)Identification: Pulsed-Field Gel Electrophoresis (PFGE)Weaned piglets1 × 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
ANNEX II"ANNEX
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-reportsCategory of zootechnical additives. Functional group: gut flora stabilisers
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 %
4b1713Evonik Operations GmbH)Enterococcus faeciumCECT 4515Additive compositionPreparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additiveSolid formsCharacterisation of the active substanceViable cells of Enterococcus faecium CECT 4515Analytical methodEnumeration: 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
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-reportsCategory of zootechnical additives. Functional group: gut flora stabilisers
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/l of water for drinking
4b1713Evonik Operations GmbH)Enterococcus faeciumCECT 4515Additive compositionPreparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additiveSolid forms.Characterisation of the active substanceViable cells of Enterococcus faecium CECT 4515Analytical methodEnumeration: spread plate method using bile esculin azide agar (EN 15788)Identification: Pulsed- Field Gel Electrophoresis (PFGE)Chickens for fattening—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.For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.4.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.5.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"
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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-reportsDetails 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