Commission Regulation (EC) No 1259/2004 of 8 July 2004 concerning the permanent authorisation of certain additives already authorised in feedingstuffs (Text with EEA relevance)
Modified by
  • Commission Implementing Regulation (EU) No 403/2013of 2 May 2013concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase produced by Trichoderma reesei (ATCC 74444) as a feed additive for poultry for fattening and for laying and for weaned piglets and amending Regulations (EC) No 1259/2004, (EC) No 1206/2005 and (EC) No 1876/2006 (holder of authorisation DSM Nutritional Products)(Text with EEA relevance), 32013R0403, May 3, 2013
  • Commission Implementing Regulation (EU) No 290/2014of 21 March 2014concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 as a feed additive for poultry, weaned piglets and pigs for fattening and amending Regulations (EC) No 1259/2004, (EC) No 943/2005, (EC) No 1206/2005 and (EC) No 322/2009 (holder of the authorisation Adisseo France S.A.S.)(Text with EEA relevance), 32014R0290, March 22, 2014
  • Commission Implementing Regulation (EU) 2015/1053of 1 July 2015concerning the authorisation of the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 as a feed additive for calves for rearing, piglets, chickens for fattening, turkeys for fattening, cats and dogs and amending Regulations (EC) No 1259/2004, (EC) No 255/2005, (EC) No 1200/2005 and (EC) No 1520/2007 (holder of authorisation Chevita Tierarzneimittel-GmbH)(Text with EEA relevance), 32015R1053, July 2, 2015
  • Commission Implementing Regulation (EU) 2017/211of 7 February 2017concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) as a feed additive for poultry, weaned piglets and pigs for fattening, and amending Regulations (EC) No 1259/2004, (EC) No 1206/2005, and (EC) No 322/2009 and repealing Regulation (EC) No 516/2007 (holder of authorisation Beldem, a division of Puratos NV)(Text with EEA relevance), 32017R0211, February 8, 2017
  • Commission Implementing Regulation (EU) 2017/1145of 8 June 2017on the withdrawal from the market of certain feed additives authorised pursuant to Council Directives 70/524/EEC and 82/471/EEC and repealing the obsolete provisions authorising those feed additives(Text with EEA relevance), 32017R1145, June 29, 2017
Commission Regulation (EC) No 1259/2004of 8 July 2004concerning the permanent authorisation of certain additives already authorised in feedingstuffs(Text with EEA relevance)
Article 1The preparation belonging to the group "micro-organisms" as set out in Annex I is authorised for use as additive in animal nutrition under the conditions laid down in that Annex.
Article 2The preparations belonging to the group "enzymes", as set out in Annexes III and VI are authorised for use without a time limit as additive in animal nutrition under the conditions laid down in those Annexes.
Article 3This Regulation shall enter into force on the third 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 StatesANNEX I
Micro-organisms
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff
E 1707Enterococcus faeciumDSM 10663/NCIMB 10415Preparation of Enterococcus faecium containing a minimum of:powder and granulated form:3,5 × 1010 CFU/g additivecoated form:2,0 × 1010 CFU/g additiveliquid form:1 × 1010 CFU/ml additiveChickens for fattening—1 × 1091 × 109In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelletingMay be used in compound feed containing the permitted coccidiostats: diclazuril, halofuginone, lasalocid sodium, maduramicin ammonium, monensin sodium, robenidineWithout a time limit
ANNEX II
1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from carboxymethylcellulose per minute at pH 5,0 and 40 °C.1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from barley beta-glucan per minute at pH 5,0 and 40 °C.1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from oat spelt xylan per minute at pH 5,0 and 40 °C.Enzymes
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
E 1602Endo-1,4-beta-glucanaseEC 3.2.1.4Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Endo-1,4-beta-xylanaseEC 3.2.1.8Preparation of endo-1,4-beta-glucanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 74 252) having a minimum activity of:Liquid and granular form:Endo-1,4-beta-glucanase:8000 U/ml or gEndo-1,3(4)-beta-glucanase:18000 U/ml or gEndo-1,4-beta-xylanase:26000 U/ml or gChickens for fattening—endo-1,4-beta-glucanase:400 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting2.Recommended dose per kg of complete feedingstuff:endo-1,4-beta-glucanase:400-1600 Uendo-1,3(4)-beta-glucanase:900-3600 Uendo-1,4-beta-xylanase:1300-5200 U3.For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 30 % wheat or barley and more than 10 % ryeWithout a time limit
endo-1,3(4)-beta-glucanase:900 U—
endo-1,4-beta-xylanase:1300 U—
ANNEX III
1 FBG is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 5,0 and 30 oC.Enzymes
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
E 1603Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94) having a minimum activity of:coated form:50 FBG/gliquid form:120 FBG/mlChickens for fattening—10 FBG—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting2.Recommended dose per kg of complete feedingstuff: 15-20 FBG3.For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans), e.g. containing more than 60 % vegetable ingredients (maize, lupin, wheat, barley, soya, rice, oilseed rape or peas)Without a time limit
ANNEX IV
1 U is the amount of enzyme which liberates 5,55 micromoles of reducing sugars (maltose equivalents) from barley beta-glucan per minute at pH 5,0 and 50 °C.1 U is the amount of enzyme which liberates 4,00 micromoles of reducing sugars (maltose equivalents) from birchwood xylan per minute at pH 5,5 and 50 °C.Enzymes
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
E 1604Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Endo-1,4-beta-xylanaseEC 3.2.1.8Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Penicillium funiculosum (IMI SD 101) having a minimum activity of:powder form:endo-1,3(4)-beta-glucanase:2000 U/gendo-1,4-beta-xylanase:1400 U/gliquid form:endo-1,3(4)-beta-glucanase:500 U/mlendo-1,4-beta-xylanase350 U/mlChickens for fattening—endo-1,3(4)-beta-glucanase:100 Uendo-1,4-beta-xylanase:70 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting2.Recommended dose per kg of complete feedingstuff:endo-1,3(4)-beta-glucanase: 100 Uendo-1,4-beta-xylanase: 70 U3.For use in compound feed rich in non-starch polysaccharides, (mainly beta-glucan and arabinoxylans), e.g. containing more than 50 % barley or 60 % wheatWithout a time limit
ANNEX V
1 U is the amount of enzyme which liberates 1 micromole of xylose from birchwood xylan per minute at pH 5,3 and 50 °C.Enzymes
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
E 1605Endo-1,4-beta-xylanaseEC 3.2.1.8Preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 520.94) having a minimum activity of:solid form:Endo-1,4-beta-xylanase:600 U/gliquid form:Endo-1,4-beta-xylanase:300 U/mlChickens for fattening—300 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting2.Recommended dose per kg of complete feedingstuff: endo-1,4-beta-xylanase: 300-600 U3.For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 50 % wheatWithout a time limit
ANNEX VI
1 IU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 30 °C.Enzymes
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
E 1606Endo-1,4-beta-xilanaseEC 3.2.1.8Preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG-S 15136) having a minimum activity of:Solid and liquid form:100 IU/g or mlChickens for fattening—10 IU—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting2.Recommended dose per kg of complete feedingstuff: 10 IU3.For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheatWithout a time limit
Article 1The preparation belonging to the group "micro-organisms" as set out in Annex I is authorised for use as additive in animal nutrition under the conditions laid down in that Annex.
Article 2The preparations belonging to the group "enzymes", as set out in Annexes III and VI are authorised for use without a time limit as additive in animal nutrition under the conditions laid down in those Annexes.
Article 3This Regulation shall enter into force on the third 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 StatesANNEX I
Micro-organisms
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff
E 1707Enterococcus faeciumDSM 10663/NCIMB 10415Preparation of Enterococcus faecium containing a minimum of:powder and granulated form:3,5 × 1010 CFU/g additivecoated form:2,0 × 1010 CFU/g additiveliquid form:1 × 1010 CFU/ml additiveChickens for fattening—1 × 1091 × 109In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelletingMay be used in compound feed containing the permitted coccidiostats: diclazuril, halofuginone, lasalocid sodium, maduramicin ammonium, monensin sodium, robenidineWithout a time limit
ANNEX II
1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from carboxymethylcellulose per minute at pH 5,0 and 40 °C.1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from barley beta-glucan per minute at pH 5,0 and 40 °C.1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from oat spelt xylan per minute at pH 5,0 and 40 °C.Enzymes
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
E 1602Endo-1,4-beta-glucanaseEC 3.2.1.4Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Endo-1,4-beta-xylanaseEC 3.2.1.8Preparation of endo-1,4-beta-glucanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 74 252) having a minimum activity of:Liquid and granular form:Endo-1,4-beta-glucanase:8000 U/ml or gEndo-1,3(4)-beta-glucanase:18000 U/ml or gEndo-1,4-beta-xylanase:26000 U/ml or gChickens for fattening—endo-1,4-beta-glucanase:400 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting2.Recommended dose per kg of complete feedingstuff:endo-1,4-beta-glucanase:400-1600 Uendo-1,3(4)-beta-glucanase:900-3600 Uendo-1,4-beta-xylanase:1300-5200 U3.For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 30 % wheat or barley and more than 10 % ryeWithout a time limit
endo-1,3(4)-beta-glucanase:900 U—
endo-1,4-beta-xylanase:1300 U—
ANNEX III
1 FBG is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 5,0 and 30 oC.Enzymes
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
E 1603Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94) having a minimum activity of:coated form:50 FBG/gliquid form:120 FBG/mlChickens for fattening—10 FBG—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting2.Recommended dose per kg of complete feedingstuff: 15-20 FBG3.For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans), e.g. containing more than 60 % vegetable ingredients (maize, lupin, wheat, barley, soya, rice, oilseed rape or peas)Without a time limit
ANNEX IV
1 U is the amount of enzyme which liberates 5,55 micromoles of reducing sugars (maltose equivalents) from barley beta-glucan per minute at pH 5,0 and 50 °C.1 U is the amount of enzyme which liberates 4,00 micromoles of reducing sugars (maltose equivalents) from birchwood xylan per minute at pH 5,5 and 50 °C.Enzymes
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
E 1604Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Endo-1,4-beta-xylanaseEC 3.2.1.8Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Penicillium funiculosum (IMI SD 101) having a minimum activity of:powder form:endo-1,3(4)-beta-glucanase:2000 U/gendo-1,4-beta-xylanase:1400 U/gliquid form:endo-1,3(4)-beta-glucanase:500 U/mlendo-1,4-beta-xylanase350 U/mlChickens for fattening—endo-1,3(4)-beta-glucanase:100 Uendo-1,4-beta-xylanase:70 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting2.Recommended dose per kg of complete feedingstuff:endo-1,3(4)-beta-glucanase: 100 Uendo-1,4-beta-xylanase: 70 U3.For use in compound feed rich in non-starch polysaccharides, (mainly beta-glucan and arabinoxylans), e.g. containing more than 50 % barley or 60 % wheatWithout a time limit
ANNEX V
1 U is the amount of enzyme which liberates 1 micromole of xylose from birchwood xylan per minute at pH 5,3 and 50 °C.Enzymes
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
E 1605Endo-1,4-beta-xylanaseEC 3.2.1.8Preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 520.94) having a minimum activity of:solid form:Endo-1,4-beta-xylanase:600 U/gliquid form:Endo-1,4-beta-xylanase:300 U/mlChickens for fattening—300 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting2.Recommended dose per kg of complete feedingstuff: endo-1,4-beta-xylanase: 300-600 U3.For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 50 % wheatWithout a time limit
ANNEX VI
1 IU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 30 °C.Enzymes
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
E 1606Endo-1,4-beta-xilanaseEC 3.2.1.8Preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG-S 15136) having a minimum activity of:Solid and liquid form:100 IU/g or mlChickens for fattening—10 IU—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting2.Recommended dose per kg of complete feedingstuff: 10 IU3.For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheatWithout a time limit