Commission Regulation (EC) No 2036/2005 of 14 December 2005 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of certain additives already authorised in feedingstuffs (Text with EEA relevance)
Modified by
  • 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) No 1206/2012of 14 December 2012concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287) as a feed additive for poultry for fattening, weaned piglets and pigs for fattening and amending Regulations (EC) No 1332/2004 and (EC) No 2036/2005 (holder of the authorisation DSM Nutritional Products)(Text with EEA relevance), 32012R1206, December 15, 2012
  • 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 authorisation Evonik Nutrition & Care GmbH)(Text with EEA relevance), 32017R0961, June 8, 2017
Commission Regulation (EC) No 2036/2005of 14 December 2005concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of certain additives already authorised in feedingstuffs(Text with EEA relevance)
Article 1The preparations belonging to the group "Micro-organisms", as specified in Annex I, are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in that Annex.
Article 2The preparations belonging to the group "Enzymes", as specified in Annex II, are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in that Annex.
Article 3The preparations belonging to the group "Enzymes", as specified in Annex III, are authorised for use for four years as additives in animal nutrition under the conditions laid down in that Annex.
Article 4This Regulation shall enter into force on the 20th day following 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
Micro-organisms
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff
E 1703Saccharomyces cerevisiaeCNCM I-1079Preparation of Saccharomyces cerevisiae containing a minimum of:2 × 1010 CFU/g additiveSows—1 × 1096 × 109In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.Without a time limit
E 1712Pediococcus acidilacticiCNCM MA 18/5MPreparation of Pediococcus acidilactici containing a minimum of:1 × 1010 CFU/g additivePigs for fattening—1 × 1091 × 109In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.Without a time limit
E 1713Enterococcus faeciumCECT 4515Preparation of Enterococcus faecium containing a minimum of:1 × 109 CFU/g additivePiglets (weaned)—1 × 1091 × 1091.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.2.For use in weaned piglets until approximately 35 kg.Without a time limit
ANNEX II
1 BU is the amount of enzyme which liberates 0,06 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,8 and 50 °C.1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 5,3 and 50 °C.1 U 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 °C.1 U is the amount of enzyme which liberates 1 microgram of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C.1 U is the amount of enzyme which hydrolyses 1 micromole of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37 °C.1 U is the amount of enzyme which liberates 1 micromole of reducing material (galacturonic acid equivalents) from a poly D-galacturonic substrate 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 1636Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (CBS 526.94) having a minimum activity of:Solid form: 700000 BU/gLiquid form: 300000 BU/gChickens for fattening—17500 BU—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: 17500-50000 BU.3.For use in compound feed rich in non-starch polysaccharides (mainly glucans), e.g. containing more than 20 % barley or 30 % rye.Without a time limit
E 1637Endo-1,4-beta-xylanaseEC 3.2.1.8Endo-1,3(4)-beta-glucanaseEC 3.2.1.6SubtilisinEC 3.4.21.62Alpha-amylaseEC 3.2.1.1PolygalacturonaseEC 3.2.1.15Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105), endo-1,3(4)-beta-glucanase and alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), subtilisin produced by Bacillus subtilis (ATCC 2107), polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) having a mimimum activity of:Endo-1,4-beta-xylanase: 300 U/gEndo-1,3(4)-beta-glucanase: 150 U/gSubtilisin: 4000 U/gAlpha-amylase: 400 U/gPolygalacturonase: 25 U/gChickens for fattening—endo-1,4-beta-xylanase:300 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-1,4-beta-xylanase: 300 Uendo-1,3(4)-beta-glucanase: 150 Usubtilisin: 4000 Ualpha-amylase: 400 Upolygalacturonase: 25 U.3.For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40 % maize or 60 % wheat.Without a time limit
endo-1,3(4)-beta-glucanase:150 U—
subtilisin:4000 U—
alpha-amylase:400 U—
polygalacturonase:25 U—
ANNEX III
1 FXU is the amount of enzyme which liberates 7,8 micromoles of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at pH 6,0 and 50 °C.1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 5,3 and 50 °C.1 U is the amount of enzyme which liberates 1 microgram of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C.1 U 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 °C.1 U is the amount of enzyme which hydrolyses 1 micromole of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37 °C.1 U is the amount of enzyme which liberates 1 micromole of reducing material (galacturonic acid equivalents) from a poly D-galacturonic substrate per minute at pH 5,0 and 40 °C.Enzymes
EC No or NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
5Endo-1,4-beta-xylanaseEC 3.2.1.8Preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287) having a minimum activity of:Coated form:1000 FXU/gLiquid form:650 FXU/mlPigs for fattening—200 FXU—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: 200-400 FXU.3.For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 50 % cereals (e.g. wheat, barley, rye or triticale).4.1.2010
Ducks—100 FXU—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: 100-200 FXU.3.For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 50 % cereals (e.g. wheat, barley, rye or triticale).4.1.2010
37Endo-1,4-beta-xylanaseEC 3.2.1.8SubtilisinEC 3.4.21.62Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105) and subtilisin produced by Bacillus subtilis (ATCC 2107) having a minimum activity of:Endo-1,4-beta-xylanase: 5000 U/gSubtilisin: 1600 U/gDucks—endo-1,4-beta-xylanase:2500 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-1,4-beta-xylanase: 2500 Usubtilisin: 800 U.3.For use in compound feed e.g. containing more than 65 % wheat.4.1.2010
subtilisin:800 U—
59Endo-1,4-beta-xylanaseEC 3.2.1.8Endo-1,3(4)-beta-glucanaseEC 3.2.1.6SubtilisinEC 3.4.21.62Alpha-amylaseEC 3.2.1.1PolygalacturonaseEC 3.2.1.15Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105), endo-1,3(4)-beta-glucanase and alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), subtilisin produced by Bacillus subtilis (ATCC 2107), polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) having a mimimum activity of:Endo-1,4-beta-xylanase: 300 U/gEndo-1,3(4)-beta-glucanase: 150 U/gSubtilisin: 4000 U/gAlpha-amylase: 400 U/gPolygalacturonase: 25 U/gDucks—endo-1,4-beta-xylanase:300 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-1,4-beta-xylanase: 300 Uendo-1,3(4)-beta-glucanase: 150 Usubtilisin: 4000 Ualpha-amylase: 400 Upolygalacturonase: 25 U.3.For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40 % maize.4.1.2010
endo-1,3(4)-beta-glucanase:150 U—
subtilisin:4000 U—
alpha-amylase:400 U—
polygalacturonase:25 U—
Laying hens—endo-1,4-beta-xylanase:225 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-1,4-beta-xylanase: 225 Uendo-1,3(4)-beta-glucanase: 112 Usubtilisin: 3000 Ualpha-amylase: 300 Upolygalacturonase: 18 U.3.For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40 % maize.4.1.2010
endo-1,3(4)-beta-glucanase:112 U—
subtilisin:3000 U—
alpha-amylase:300 U—
polygalac-turonase:18 U—
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