Commission Implementing Regulation (EU) 2017/447 of 14 March 2017 concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, weaned piglets, pigs for fattening, calves for rearing and turkeys for fattening and amending Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance. )
Modified by
  • Commission Implementing Regulation (EU) 2023/2662of 29 November 2023amending Implementing Regulation (EU) 2017/447 as regards the terms of the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) for turkeys for fattening (holder of authorisation: Chr. Hansen A/S)(Text with EEA relevance), 32023R2662, November 30, 2023
Commission Implementing Regulation (EU) 2017/447of 14 March 2017concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, weaned piglets, pigs for fattening, calves for rearing and turkeys for fattening and amending Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 (holder of authorisation Chr. Hansen A/S)(Text with EEA relevance)
Article 1AuthorisationThe 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 2Amendment to Regulation (EC) No 1453/2004Annex I to Regulation (EC) No 1453/2004 is deleted.
Article 3Amendment to Regulation (EC) No 2148/2004In Annex II to Regulation (EC) No 2148/2004 the entry E 1700 on Bacillus licheniformis (DSM 5749) and Bacillus subtilis (DSM 5750) is deleted.
Article 4Amendment to Regulation (EC) No 600/2005In Annex III to Regulation (EC) No 600/2005 the entry E 1700 on Bacillus licheniformis (DSM 5749) and Bacillus subtilis (DSM 5750) is deleted.
Article 5Transitional measuresThe preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 4 October 2017 in accordance with the rules applicable before 4 April 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 6Entry 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
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 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
4b1700iChr. Hansen A/SBacillus subtilis(DSM 5750) and Bacillus licheniformis (DSM 5749)Additive compositionPreparation of Bacillus subtilis(DSM 5750) and Bacillus licheniformis (DSM 5749) containing a minimum of 3,2 × 1010 CFU/g of additive(1:1 ratio)Solid formCharacterisation of the active substanceViable spores of Bacillus subtilis(DSM 5750) and Bacillus licheniformis (DSM 5749)Analytical methodIdentification and enumeration of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:Identification: Pulsed Field Gel Electrophoresis (PFGE)Enumeration: Spread plate method using tryptone soya agar — EN 15784.Weaned pigletsPigs for fatteningSowsCalves for rearingTurkeys for fattening—1,3 × 109—6,5 × 108—1.In the directions for use of the additive and premixtures, indicate the storage temperature, storage life and stability to pelleting.2.The additive may be used in water for drinking.3.For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.4.For use in weaned piglets up to 35 kg of body weight.5.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 protection and skin protection.6.The additive may be used in turkeys for fattening in compound feed containing formic acid, or containing the following coccidiostats, where authorised as feed additives for the same animal species and category: semduramycin, maduramicin ammonium, diclazuril, monensin sodium and lasalocid sodium with a maximum content of 90 mg of lasalocid sodium/kg of complete feedingstuff with a moisture content of 12 %.4 April 2027
Article 1AuthorisationThe 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 2Amendment to Regulation (EC) No 1453/2004Annex I to Regulation (EC) No 1453/2004 is deleted.
Article 3Amendment to Regulation (EC) No 2148/2004In Annex II to Regulation (EC) No 2148/2004 the entry E 1700 on Bacillus licheniformis (DSM 5749) and Bacillus subtilis (DSM 5750) is deleted.
Article 4Amendment to Regulation (EC) No 600/2005In Annex III to Regulation (EC) No 600/2005 the entry E 1700 on Bacillus licheniformis (DSM 5749) and Bacillus subtilis (DSM 5750) is deleted.
Article 5Transitional measuresThe preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 4 October 2017 in accordance with the rules applicable before 4 April 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 6Entry 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
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 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
4b1700iChr. Hansen A/SBacillus subtilis(DSM 5750) and Bacillus licheniformis (DSM 5749)Additive compositionPreparation of Bacillus subtilis(DSM 5750) and Bacillus licheniformis (DSM 5749) containing a minimum of 3,2 × 1010 CFU/g of additive(1:1 ratio)Solid formCharacterisation of the active substanceViable spores of Bacillus subtilis(DSM 5750) and Bacillus licheniformis (DSM 5749)Analytical methodIdentification and enumeration of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:Identification: Pulsed Field Gel Electrophoresis (PFGE)Enumeration: Spread plate method using tryptone soya agar — EN 15784.Weaned pigletsPigs for fatteningSowsCalves for rearingTurkeys for fattening—1,3 × 109—6,5 × 108—1.In the directions for use of the additive and premixtures, indicate the storage temperature, storage life and stability to pelleting.2.The additive may be used in water for drinking.3.For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.4.For use in weaned piglets up to 35 kg of body weight.5.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 protection and skin protection.6.The additive may be used in turkeys for fattening in compound feed containing formic acid, or containing the following coccidiostats, where authorised as feed additives for the same animal species and category: semduramycin, maduramicin ammonium, diclazuril, monensin sodium and lasalocid sodium with a maximum content of 90 mg of lasalocid sodium/kg of complete feedingstuff with a moisture content of 12 %.4 April 2027