
Article 1 
The preparations belonging to the groups ‘Micro-organisms’ and ‘Enzymes’, as set out in Annexes I and II are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in those Annexes.
Article 2 
This 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.Done at Brussels, 16 August 2004.
For the Commission
David BYRNE
Member of the Commission
ANNEX I

EC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation
CFU/kg of complete feedingstuff
Micro-organisms
E 1700 Bacillus 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) Sows — 1,28 × 109 1,28 × 109 In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.For sows two weeks before farrowing and during the lactation. Without a time limit
E 1701 Bacillus cereus var. toyoiNCIMB 40112/CNCM I-1012 Preparation of Bacillus cereus var. toyoi containing a minimum of 1 × 1010 CFU/g additive Piglets From two to four months 0,5 × 109 1 × 109 In the directions for use of the additive and premixture indicate the storage temperature, storage life and stability to pelleting. Without a time limit
Pigs for fattening From four months until slaughter 0,2 × 109 1 × 109 In the directions for use of the additive and premixture indicate the storage temperature, storage life and stability to pelleting. Without a time limit
ANNEX II

EC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation
Units of activity/kg of complete feedingstuff
Enzymes
E 1609 Endo-1,4-beta-xylanaseEC 3.2.1.8Endo-1,4-beta-glucanaseEC 3.2.1.4 Preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 600.94) having minimum activities of:
 Coated form:
 Endo-1,4-beta-xylanase: 36 000 FXU/g
 Endo-1,4-beta-glucanase: 15 000 BGU/g
 Liquid form:
 Endo-1,4-beta-xylanase: 36 000 FXU/ml
 Endo-1,4-beta-glucanase: 15 000 BGU/ml
 Solid form:
 Endo-1,4-beta-xylanase: 36 000 FXU/g
 Endo-1,4-beta-glucanase: 15 000 BGU/g Chickens for fattening — 4 860 FXU — 
1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

2. 

 4 860–6 000 FXU
 2 025–2 500 BGU.

3. For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 35 % barley and 20 % wheat.
 Without a time limit
2 025 BGU —
Turkeys for fattening — 6 000 FXU — 
1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

2. 
6 000 FXU

2 500 BGU.

3. For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 40 % wheat.
 Without a time limit
2 500 BGU —
Piglets (weaned) — 6 000 FXU — 
1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

2. 

 6 000 FXU
 2 500 BGU.

3. For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 30 % wheat and 30 % barley.

4. For use in weaned piglets until approximately 35 kg.
 Without a time limit
2 500 BGU —
E 1610 Endo-1,4-beta-glucanaseEC 3.2.1.4Endo-1,4-beta-xylanaseEC 3.2.1.8 Preparation of endo-1,4-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 600.94) having minimum activities of:
 Coated form:
 Endo-1,4-beta-glucanase: 10 000 BGU/g
 Endo-1,4-beta-xylanase: 4 000 FXU/g
 Liquid form:
 Endo-1,4-beta-glucanase: 20 000 BGU/ml
 Endo-1,4-beta-xylanase: 8 000 FXU/ml
 Solid form:
 Endo-1,4-beta-glucanase: 20 000 BGU/g
 Endo-1,4-beta-xylanase: 8 000 FXU/g Chickens for fattening — 5 000 BGU — 
1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

2. 

 5 000–10 000 BGU
 2 000–4 000 FXU.

3. For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 60 % barley.
 Without a time limit
2 000 FXU —
E 1611 Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Endo-1,4-beta-xylanaseEC 3.2.1.8PolygalacturonaseEC 3.2.1.15 Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 2106) and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (IMI SD 135) and polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) having a minimum activity of:
 Endo-1,3(4)-beta-glucanase: 400 U/g
 Endo-1,4-beta-xylanase: 400 U/g
 Polygalacturonase: 50 U/g Pigs for fattening — endo-1,3(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 pelleting.

2. 

 endo-1,3(4)-beta-glucanase: 400 U
 endo-1,4-beta-xylanase: 400 U
 polygalacturonase: 50 U.

3. For use in compound feed containing cereals rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40 % barley.
 Without a time limit
endo-1,4-beta-xylanase: 400 U —
polygalacturonase: 50 U —
E 1612 Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Endo-1,4-beta-xylanaseEC 3.2.1.8Alpha-amylaseEC 3.2.1.1 Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (phoenicis) (NRRL 25541) and of alpha-amylase produced by Aspergillus oryzae (ATCC 66222) having a minimum activity of:
 Endo-1,3(4)-beta-glucanase: 275 U/g
 Endo-1,4-beta-xylanase: 400 U/g
 Alpha-amylase: 3 100 U/g Piglets (weaned) — endo-1,3(4)-beta-glucanase: 138 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: 138 U
 endo-1,4-beta-xylanase: 200 U
 alpha-amylase: 1 550 U

3. For use in compound feeds rich in starch and non-starch polysaccharides, for example mixed diets containing barley, maize, wheat.

4. For use in weaned piglets until approximately 35 kg.
 Without a time limit
endo-1,4-beta-xylanase: 200 U —
alpha-amylase: 1 550 U —
E 1613 Endo-1,4-beta-xylanaseEC 3.2.1.8 Preparation of endo-1,4-beta-xylanase, produced from Trichoderma longibrachiatum (CNCM MA 6 - 10W), having a minimum activity of:
 Powder form:
70 000 IFP/g
 Liquid form:
7 000 IFP/ml Chickens for fattening — 1 050 IFP — 
1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

2. 
1 400 IFP.

3. For use in compound feeds rich in non-starch polysaccharides (mainly arabinoxylans), for example more than 40 % wheat.
 Without a time limit










