
Article 1 
The preparations belonging to the group ‘Micro-organisms’ listed in Annex I to the present Regulation are authorised for use as additives in animal nutrition under the conditions laid down in that Annex.
Article 2 
The preparations belonging to the group ‘Enzymes’ listed in Annex II to the present Regulation are authorised for use as additives in animal nutrition under the conditions laid down in that Annex.
Article 3 
The additive belonging to the group ‘Coccidiostats and other medicinal substances’ listed in Annex III to the present Regulation is authorised for use as additive in animal nutrition under the conditions laid down in that Annex.
Article 4 
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Communities.
It shall apply from 1 March 2001.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I

No (or EC No) Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions Period of authorisation
CFU/kg of complete feedingstuff CFU/kg of complete feedingstuff
20 Bacillus licheniformisDSM 5749Bacillus subtilisDSM 5750(In a 1/1 ratio) Mixture of Bacillus licheniformis and Bacillus subtilis containing a minimum of
 3,2 × 109 CFU/g of the additive
(1,6 × 109 UFC/g of each bacterium) Calves 6 month 1,28 × 109 1,6 × 109 In the directions for use of the additive and premixture, indicate the storage temeprature, storage life, and stability to pelleting. 28.2.2005
21 Enterococcus faeciumDSM 3530 Preparation of Enterococcus faecium containing a minimum of
 2,5 × 109 CFU/g Calves 6 months 1 × 109 1 × 109 In the directions for use of the additive and premixture, indicate the storage temeprature, storage life, and stability to pelleting 28.2.2005
ANNEX II

No (or EC No) Additive Chemical formula, decription Species or category of animal Maximum age Minimum content Maximum content Other provisions Period of authorisation
Units of activity/kg complete feedingstuff Units of activity/kg complete feedingstuff
23 Endo-1,4-beta-xylanaseEC 3.2.1.8 Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10W) having a minimum of activity of:
 Solid form: 70 000 IFP /g
 Liquid form: 7 000 IFP/ml Turkeys for fattening — 700 IFP — 
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 kilogram of complete feedingstuff: 1 400 IFP

3. For use in compound feed rich in non- starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat
 28.2.2005
Laying hens — 840 IFP — 
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 kilogram of complete feedingstuff: 840 IFP

3. For use in compound feed rich in non- starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat
 28.2.2005
27 Endo-1,4-beta-xylanaseEC 3.2.1.8Endo-1,3(4)-beta-glucanaseEC 3.2.1.6 Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 529.94) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (CBS 526.94) having a minimum activity of:
 Solid form:
200 000 BXU /g
200 000 BU /g
 Liquid form:
30 000 BXU/g
30 000 BU/g Piglets 2 months 7 500 BXU — 
1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting

2. 

 7 500 to 15 000 BXU
 7 500 to 15 000 BU

3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 50 % wheat
 28.2.2005
7 500 BU —
28 3-PhytaseEC 3.1.3.8 Preparation of 3-phytase produced by Trichoderma reesei (CBS 528.94) having a minimum activity of
 Solid form: 5 000 PPU /g
 Liquid form: 1 000 PPU/g Chickens for fattening — 500 PPU — 
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 kilogram of complete feedingstuff: 500 to 750 PPU

3. For use in compound feed containing more than 0,22 % phytin bound phosphorus
 28.2.2005
30 Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Endo-1,-beta-xylanaseEC 3.2.1.8 Preparation 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: 2 000 U /g
Endo-1,4-beta-xylanase: 1 400 U/g /g
 Liquid form:
Endo-1,3(4)-beta-glucanase: 500 U/ml
Endo-1,4-beta-xylanase: 350 U/ml Turkeys 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. 

 endo-1,3(4)-beta-glucanase: 100 U
 endo-1,4-beta-xylanase: 70 U

3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 50 % wheat
 28.2.2005
Endo-1,4-beta-xylanase:70 U —
Laying hens — 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 stabiltiy to pelleting

2. 

 endo-1,3(4)-beta-glucanase: 100 U
 endo-1,4-beta-xylanase: 70 U

3. For use in compound feed rich in non-starch polysaccharides (mainly beta- glucans and arabinoxylans), e.g. continaing more than 60 % barley or 30 % wheat
 28.2.2005
Endo-1,4-beta-xylanase:70 U —
Pigs 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. 

 endo-1,3(4)-beta-glucanase: 100 U
 endo-1,4-beta-xylanase: 70 U

3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 50 % barley or 60 % wheat
 28.2.2005
Endo-1,4-beta-xylanase:70 U —
59 Endo-1,4-beta-xylanaseEC 3.2.1.8 Preparation 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 minimum activity of:
 Endo-1,4-beta-xylanase: 300 U /g
 Endo-1,3(4)-beta-glucanase: 150 U /g
 Subtilisin: 4 000 U /g
 Alpha-amylase: 400 U /g
 Polygalacturonase: 25 U /g Chickens 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 stbility to pelleting

2. 

 endo-1,4-beta-xylanase: 300 U
 endo-1,3(4)-beta-glucanase: 150 U
 subtilisin: 4 000 U
 alpha-amylase: 400 U
 polygalacturonase: 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
 28.2.2005
Endo-1,3(4)-beta-glucanaseEC 3.2.1.6 Endo-1,3(4)-beta-glucanase:150 U —
SubtilisinEC 3.4.21.62 Subtilisin:4 000 U —
Alpha-amylaseEC 3.2.1.1 Alpha-amylase:400 U —
PolygalacturonaseEC 3.2.1.15 Polygalacturonase:25 U —
60 Endo-1,4-beta-xylanaseEC 3.2.1.8 Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105), endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 2106) having a minimum activitiy of:
 Endo-1,4-beta-xylanase: 5 000 U /g
 Endo-1,3(4)-beta-glucanase: 50 U /g Chickens for fattening — Endo-1,4-beta-xylanase:500 U — 
1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.

2. 

 endo-1,4-beta-xylanase: 500 to 2 500 U
 endo-1,3(4)-beta-glucanase: 5 to 25 U

3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 20 % barley and 40 % wheat
 28.2.2005
Endo-1,3(4)-beta-glucanaseEC 3.2.1.6 Endo-1,3(4)-beta-glucanase:5 U —
61 Endo-1,4-beta-xylanaseEC 3.2.1.8 Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 526.94) having a minimum activity of:
 Powder form:
Endo-1,(4)-beta-xylanase: 17 000 BXU /g
Endo-1,3(4)-beta-xylanase: 11 000 BU/ /g
 Liquid form:
Endo-1,4-beta-xylanase: 22 000 U/ml
Endo-1,3(4)-beta-glucanase: 15 000 U/ml Chickens for fattening — Endo-1,4-beta-xylanase:17 000 BXU — 
1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting

2. 

 endo-1,4-beta-xylanase: 17 000 BXU
 endo-1,3(4)-beta-glucanase: 11 000 BU

3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 40 % barley or 55 % wheat
 28.2.2005
Endo-1,3(4)-beta-glucanaseEC 3.2.1.6 Endo-1,3(4)-beta-glucanase:11 000 BU —











ANNEX III

Registration number of additive Name and registration number of person responsible for putting additive into circulation Additive(trade name) Composition, chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff
Coccidiostats and other medicinal substances
E 771 Janssen Pharmaceutica nv Diclazuril0,5 g/100 g(Clinacox 0,5 % Premix)Diclazuril0,2 g/100 g(Clinacox 0,2 % Premix) 
 Additive composition:
 Diclazuril: 0,5 g/100 g
 Soybean meal: 99,25 g/100 g
 Polyvidone K 30: 0,2 g/100 g
 Sodium hydroxide: 0,0538 g/100 g
 Diclazuril: 0,2 g/100 g
 Soybean meal: 39,7 g/100 g
 Polyvidone K 30: 0,08 g/100 g
 Sodium hydroxide: 0,0215 g/100 g
 Wheat middling: 60 g/100 g
 Active substance:
 Diclazuril
 C17H9Cl3N4O2,
 (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,
 CAS number: 101831-37-2
 Related impurities:
 Degradation compound (R064318): ≤ 0,2 %
 Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually
 Total impurities: ≤ 1,5 % Turkeys for fattening 12 weeks 1 1 — 28.2.2011 1 500 μg diclazuril/kg of wet liver1 000 μg diclazuril/kg of wet kidney500 μg diclazuril/kg of wet muscle500 μg diclazuril/kg of wet skin/fat