Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs - Text with EEA relevance
Modified by
  • Commission Regulation (EC) No 1980/2005of 5 December 2005amending the conditions for authorisation of a feed additive belonging to the group of trace elements and of a feed additive belonging to the group of binders and anti-caking agents(Text with EEA relevance), 32005R1980, December 6, 2005
  • Commission Implementing Regulation (EU) No 1018/2012of 5 November 2012amending Regulations (EC) No 232/2009, (EC) No 188/2007, (EC) No 186/2007, (EC) No 209/2008, (EC) No 1447/2006, (EC) No 316/2003, (EC) No 1811/2005, (EC) No 1288/2004, (EC) No 2148/2004, (EC) No 1137/2007, (EC) No 1293/2008, (EC) No 226/2007, (EC) No 1444/2006, (EC) No 1876/2006, (EC) No 1847/2003, (EC) No 2036/2005, (EC) No 492/2006, (EC) No 1200/2005, and (EC) No 1520/2007 as regards the maximum content of certain micro-organisms in complete feedingstuffs(Text with EEA relevance), 32012R1018, November 7, 2012
  • Commission Implementing Regulation (EU) 2015/1043of 30 June 2015concerning the authorisation of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) as a feed additive for chickens for fattening, turkeys for fattening, laying hens, weaned piglets, pigs for fattening and minor poultry species for fattening and for laying, and amending Regulations (EC) No 2148/2004, (EC) No 828/2007 and (EC) No 322/2009 (holder of authorisation Huvepharma NV)(Text with EEA relevance), 32015R1043, July 1, 2015
  • 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), 32015R2305, December 11, 2015
  • 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), 32017R0447, March 15, 2017
Commission Regulation (EC) No 2148/2004of 16 December 2004concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs(Text with EEA relevance)
Article 1The preparation belonging to the group "Binders, anti-caking agents and coagulants", is authorised for use without a time limit as additive in animal nutrition under the conditions laid down in Annex I.
Article 2The preparations belonging to the group "Micro-organisms", are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in Annex II.
Article 3The preparation belonging to the group "Micro-organisms", is authorised provisionally for four years as additive in animal nutrition under the conditions laid down in Annex III.
Article 4The preparations belonging to the group "Enzymes", are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in Annex IV.
Article 5The preparation belonging to the group "Enzymes", is authorised provisionally for four years as additive in animal nutrition under the conditions laid down in Annex V.
Article 6This 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 States.ANNEX I
Binders, anti-caking agents and coagulants
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg/kg of complete feedingstuff
E 567Clinoptilolite of volcanic originCalcium hydrated aluminosilicate of volcanic origin containing a minimum of 85 % of clinoptilolite and a maximum of 15 % of feldspar, micas and clays free of fibres and quartzMaximum lead content: 80 mg/kgPigs——20000All feedingstuffsWithout a time limit
Rabbits——20000All feedingstuffsWithout a time limit
Poultry——20000All feedingstuffsWithout a time limit
ANNEX II
Micro-organisms
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff
E 1700Bacillus licheniformisDSM 5749Bacillus subtilisDSM 5750(In 1/1 ratio)Mixture of Bacillus licheniformis and Bacillus subtilis containing a minimum of:3,2 × 109 CFU/g additive (1,6 × 109 CFU/g additive of each bacterium)Pigs for fattening—1,28 × 1091,28 × 109In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.Without a time limit
Piglets—1,28 × 1093,2 × 109In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.For use in piglets until approximately 35 kg.Without a time limit
E 1702Saccharomyces cerevisiaeNCYC Sc 47Preparation of Saccharomyces cerevisiae containing a minimum of:5 × 109 CFU/g additivePiglets(weaned)—5 × 1091 × 1010In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.For use in weaned piglets until approximately 35 kg.Without a time limit
E 1706Enterococcus faeciumDSM 7134Lactobacillus rhamnosusDSM 7133Mixture of:Enterococcus faecium containing a minimum of: 7 × 109 CFU/gand ofLactobacillus rhamnosus containing a minimum of: 3 × 109 CFU/gPiglets(weaned)—2,5 × 1095 × 109In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.For use in weaned piglets until approximately 35 kg.Without a time limit
ANNEX III
Micro-organisms
No (or EC No)AdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff
24Kluyveromyces marxianus var. lactisK1 BCCM/MUCL 39434Preparation of Kluyveromyces marxianus var. lactisK1 having a minimum activity of: 1,0 × 108 CFU/gDairy cows—0,25 × 1061,0 × 106In directions for use of the additive and premixture, indicate the storage temperature and storage life.Do not use in pelleted premixture and feedingstuffs.Use in dairy cows, in particular when they are reaching the maximum of daily milk production, for minimum period of 14 days.The amount of daily ration administered to each cow is 1,0 × 107 CFU.20 December 2008
ANNEX IV
1 BGN is the amount of enzyme which liberates 1 micromole of reducing sugar (glucose equivalents) from barley beta-glucan per minute at pH 4,8 and 50 °C.1 CU is the amount of enzyme which liberates 0,128 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,5 and 30 °C.1 EPU is the amount of enzyme which liberates 0,0083 micromoles of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 4,7 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 1615Endo-1,3(4)-beta-glucanase EC 3.2.1.6Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (CNCM MA 6-10 W) having a minimum activity of:Solid form: 70000 BGN/gLiquid form: 14000 BGN/mlChickens for fattening—1050 BGN—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff:2800 BGN.3.For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans), e.g. containing more than 35 % barley.Without a time limit
E 1616Endo-1,4-beta-glucanase EC 3.2.1.4Preparation of endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (IMI SD 142) having a minimum activity of:Solid form: 2000 CU/gLiquid form: 2000 CU/mlChickens for fattening—500 CU—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.2.Recommended dose per kg of complete feedingstuff:500-1000 CU.3.For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans), e.g. containing more than 40 % barley.Without a time limit
E 1617Endo-1,4-beta-xylanase EC 3.2.1.8Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (IMI SD 135) having a minimum activity of:Solid form: 6000 EPU/gLiquid form: 6000 EPU/mlChickens for fattening—1500 EPU—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.2.Recommended dose per kg of complete feedingstuff:1500-3000 EPU.3.For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat.Without a time limit
ANNEX V
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
No(or EC No)AdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
30 (or E 1604)Endo-1,3(4)-beta-glucanase EC 3.2.1.6Endo-1,4-beta-xylanase EC 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-xylanase:350 U/mlPiglets (weaned)endo-1,3(4)-beta-glucanase: 100 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.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 30 % barley or 20 % wheat.4.For weaned piglets up to approximately 35 kg.20.12.2008
endo-1,4-beta-xylanase: 70 U—
Ducks for fattening—endo-1,3(4)-beta-glucanase: 100 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.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 % wheat.20.12.2008
endo-1,4-beta-xylanase: 70 U—
Article 1The preparation belonging to the group "Binders, anti-caking agents and coagulants", is authorised for use without a time limit as additive in animal nutrition under the conditions laid down in Annex I.
Article 2The preparations belonging to the group "Micro-organisms", are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in Annex II.
Article 3The preparation belonging to the group "Micro-organisms", is authorised provisionally for four years as additive in animal nutrition under the conditions laid down in Annex III.
Article 4The preparations belonging to the group "Enzymes", are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in Annex IV.
Article 5The preparation belonging to the group "Enzymes", is authorised provisionally for four years as additive in animal nutrition under the conditions laid down in Annex V.
Article 6This 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 States.ANNEX I
Binders, anti-caking agents and coagulants
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg/kg of complete feedingstuff
E 567Clinoptilolite of volcanic originCalcium hydrated aluminosilicate of volcanic origin containing a minimum of 85 % of clinoptilolite and a maximum of 15 % of feldspar, micas and clays free of fibres and quartzMaximum lead content: 80 mg/kgPigs——20000All feedingstuffsWithout a time limit
Rabbits——20000All feedingstuffsWithout a time limit
Poultry——20000All feedingstuffsWithout a time limit
ANNEX II
Micro-organisms
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff
E 1700Bacillus licheniformisDSM 5749Bacillus subtilisDSM 5750(In 1/1 ratio)Mixture of Bacillus licheniformis and Bacillus subtilis containing a minimum of:3,2 × 109 CFU/g additive (1,6 × 109 CFU/g additive of each bacterium)Pigs for fattening—1,28 × 1091,28 × 109In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.Without a time limit
Piglets—1,28 × 1093,2 × 109In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.For use in piglets until approximately 35 kg.Without a time limit
E 1702Saccharomyces cerevisiaeNCYC Sc 47Preparation of Saccharomyces cerevisiae containing a minimum of:5 × 109 CFU/g additivePiglets(weaned)—5 × 1091 × 1010In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.For use in weaned piglets until approximately 35 kg.Without a time limit
E 1706Enterococcus faeciumDSM 7134Lactobacillus rhamnosusDSM 7133Mixture of:Enterococcus faecium containing a minimum of: 7 × 109 CFU/gand ofLactobacillus rhamnosus containing a minimum of: 3 × 109 CFU/gPiglets(weaned)—2,5 × 1095 × 109In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.For use in weaned piglets until approximately 35 kg.Without a time limit
ANNEX III
Micro-organisms
No (or EC No)AdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff
24Kluyveromyces marxianus var. lactisK1 BCCM/MUCL 39434Preparation of Kluyveromyces marxianus var. lactisK1 having a minimum activity of: 1,0 × 108 CFU/gDairy cows—0,25 × 1061,0 × 106In directions for use of the additive and premixture, indicate the storage temperature and storage life.Do not use in pelleted premixture and feedingstuffs.Use in dairy cows, in particular when they are reaching the maximum of daily milk production, for minimum period of 14 days.The amount of daily ration administered to each cow is 1,0 × 107 CFU.20 December 2008
ANNEX IV
1 BGN is the amount of enzyme which liberates 1 micromole of reducing sugar (glucose equivalents) from barley beta-glucan per minute at pH 4,8 and 50 °C.1 CU is the amount of enzyme which liberates 0,128 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,5 and 30 °C.1 EPU is the amount of enzyme which liberates 0,0083 micromoles of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 4,7 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 1615Endo-1,3(4)-beta-glucanase EC 3.2.1.6Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (CNCM MA 6-10 W) having a minimum activity of:Solid form: 70000 BGN/gLiquid form: 14000 BGN/mlChickens for fattening—1050 BGN—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff:2800 BGN.3.For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans), e.g. containing more than 35 % barley.Without a time limit
E 1616Endo-1,4-beta-glucanase EC 3.2.1.4Preparation of endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (IMI SD 142) having a minimum activity of:Solid form: 2000 CU/gLiquid form: 2000 CU/mlChickens for fattening—500 CU—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.2.Recommended dose per kg of complete feedingstuff:500-1000 CU.3.For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans), e.g. containing more than 40 % barley.Without a time limit
E 1617Endo-1,4-beta-xylanase EC 3.2.1.8Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (IMI SD 135) having a minimum activity of:Solid form: 6000 EPU/gLiquid form: 6000 EPU/mlChickens for fattening—1500 EPU—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.2.Recommended dose per kg of complete feedingstuff:1500-3000 EPU.3.For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat.Without a time limit
ANNEX V
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
No(or EC No)AdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
30 (or E 1604)Endo-1,3(4)-beta-glucanase EC 3.2.1.6Endo-1,4-beta-xylanase EC 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-xylanase:350 U/mlPiglets (weaned)endo-1,3(4)-beta-glucanase: 100 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.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 30 % barley or 20 % wheat.4.For weaned piglets up to approximately 35 kg.20.12.2008
endo-1,4-beta-xylanase: 70 U—
Ducks for fattening—endo-1,3(4)-beta-glucanase: 100 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.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 % wheat.20.12.2008
endo-1,4-beta-xylanase: 70 U—