Commission Implementing Regulation (EU) 2015/2305 of 10 December 2015 concerning the authorisation of a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets, and amending Regulations (EC) No 2148/2004 and (EC) No 1520/2007 (holder of authorisation Huvepharma NV) (Text with EEA relevance)
Modified by
  • Commission Implementing Regulation (EU) 2024/262of 17 January 2024concerning the renewal of the authorisation of a preparation of endo-1,4-beta-glucanase produced by Trichoderma citrinoviride IMI 360748 as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets, the authorisation of that preparation as a feed additive for turkeys for fattening, all poultry species reared for laying or breeding, ornamental birds and suckling piglets (holder of the authorisation: Huvepharma NV) and amending Implementing Regulation (EU) 2015/2305(Text with EEA relevance), 32024R0262, January 18, 2024
Commission Implementing Regulation (EU) 2015/2305of 10 December 2015concerning the authorisation of a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets, and amending Regulations (EC) No 2148/2004 and (EC) No 1520/2007 (holder of authorisation Huvepharma NV)(Text with EEA relevance)
Article 1AuthorisationThe preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "digestibility enhancers", is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Amendment to Regulation (EC) No 2148/2004In Annex IV to Regulation (EC) No 2148/2004 the entry on E 1616, endo-1,4-beta-glucanase, is deleted.
Article 3Amendment to Regulation (EC) No 1520/2007Regulation (EC) No 1520/2007 is amended as follows:(1)Article 5 is deleted;(2)Annex V is deleted.
Article 4Transitional measuresThe preparation specified in the Annex, and feed containing that preparation, which is produced and labelled before 30 June 2016 in accordance with the rules applicable before 31 December 2015 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
1 CU is the amount of enzyme that liberates 0,128 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,5 and 30 °C.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: digestibility enhancers.
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
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
4a1616Huvepharma NVEndo-1,4-beta-glucanaseEC 3.2.1.4Additive composition:Preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) with a minimum activity of 2000 CU/g (solid and liquid form).Characterisation of the active substance:Endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142).Analytical method:For the determination of endo-1,4-beta-glucanase in feed additive, premixtures and feedingstuffs:colorimetric method based on the quantification of water soluble dyed fragments (azurine) produced by the action of endo-1,4-beta-glucanase on azurine-crosslinked cellulose.Chickens for fattening and minor poultry species for fattening—500 CU—1.In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.2.For safety: breathing protection, glasses and gloves shall be used during handling.3.For use in weaned piglets until approximately 35 kg.31 December 2025
Weaned piglets350 CU
Article 1AuthorisationThe preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "digestibility enhancers", is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Amendment to Regulation (EC) No 2148/2004In Annex IV to Regulation (EC) No 2148/2004 the entry on E 1616, endo-1,4-beta-glucanase, is deleted.
Article 3Amendment to Regulation (EC) No 1520/2007Regulation (EC) No 1520/2007 is amended as follows:(1)Article 5 is deleted;(2)Annex V is deleted.
Article 4Transitional measuresThe preparation specified in the Annex, and feed containing that preparation, which is produced and labelled before 30 June 2016 in accordance with the rules applicable before 31 December 2015 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
1 CU is the amount of enzyme that liberates 0,128 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,5 and 30 °C.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: digestibility enhancers.
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
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
4a1616Huvepharma NVEndo-1,4-beta-glucanaseEC 3.2.1.4Additive composition:Preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) with a minimum activity of 2000 CU/g (solid and liquid form).Characterisation of the active substance:Endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142).Analytical method:For the determination of endo-1,4-beta-glucanase in feed additive, premixtures and feedingstuffs:colorimetric method based on the quantification of water soluble dyed fragments (azurine) produced by the action of endo-1,4-beta-glucanase on azurine-crosslinked cellulose.Chickens for fattening and minor poultry species for fattening—500 CU—1.In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.2.For safety: breathing protection, glasses and gloves shall be used during handling.3.For use in weaned piglets until approximately 35 kg.31 December 2025
Weaned piglets350 CU