
Article 1 
The preparations belonging to the group ‘Enzymes’, as specified in Annex I, are authorised without a time limit as additives in animal nutrition under the conditions laid down in that Annex.
Article 2 
The preparation belonging to the group ‘Coccidiostat and other medicinal substances’, as specified in Annex II, is authorised for 10 years as additive in animal nutrition under the conditions laid down in that Annex.
Article 3 
The preparation belonging to the group ‘Vitamins, provitamins and chemically well-defined substances having similar effect’, as specified in Annex III, is authorised without a time limit as additive in animal nutrition under the conditions laid down in that Annex.
Article 4 
This 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.Done at Brussels, 29 September 2006.
For the Commission
Markos KYPRIANOU
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
Units of activity/kg of complete feedingstuff
Enzymes
E 1639 3-phytaseEC 3.1.3.8 Preparation of 3-phytase produced by Hansenula polymorpha (DSM 15087) having a minimum activity of:
 Coated form: 2 500 U/g
 Liquid forms: 5 000 U/g Chickens for fattening — 250 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: 250-1 000 U/kg

3. For use in compound feed rich in phytin-bound phosphorus such as maize, soya, wheat, barley, rye.
 Without a time limit
Turkeys for fattening — 250 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: 250-1 000 U/kg

3. For use in compound feed rich in phytin-bound phosphorus such as maize, soya, wheat, barley, rye.
 Without a time limit
Laying hens — 250 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: 250-1 000 U/kg

3. For use in compound feed rich in phytin-bound phosphorus such as maize, soya, wheat, barley, rye.
 Without a time limit
Piglets Four months 500 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: 500-1 000 U/kg

3. For use in compound feed rich in phytinbound phosphorus such as maize, soya, wheat, barley, rye.
 Without a time limit
Pigs for fattening — 250 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: 250-1 000 U/kg

3. For use in compound feed rich in phytinbound phosphorus such as maize, soya, wheat, barley, rye.
 Without a time limit
Sows — 500 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: 500-1 000 U/kg

3. For use in compound feed rich in phytinbound phosphorus such as maize, soya, wheat, barley, rye.
 Without a time limit
E 1628 Endo-1,4-beta-xylanaseEC 3.2.1.8 Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105) having a minimum activity of:
 Powder form:
Endo-1,4-beta-xylanase: 8 000 U/g
 Liquid form:
Endo-1,4-beta-xylanase: 8 000 U/ml Piglets (weaned) — Endo-1,4-beta-xylanase: 4 000 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: 4 000 U.

3. For use in compound feed rich in nonstarch polysaccharides (mainly arabinoxylans), e.g. containing more than 35 % wheat.

4. For use in weaned piglets until approximately 35 kg.
 Without a time limit


ANNEX II

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
mg of active substance/kg of complete feedingstuff
Coccidiostats and other medicinal substances
E 773 Phibro Animal Health, s.a. Semduramicin sodium(Aviax 5 %) 
 Additive composition:
Semduramicin sodium: 51,3 g/kg
Sodium carbonate: 40 g/kg
Mineral oil: 30-50 g/kg
Sodium aluminosilicate: 20 g/kg
Soybean mill run: 838,7-858,7 g/kg
 Active substance:
Semduramicin
C45H76O16
CAS number: 113378-31-7
Semduramicin sodium
C45H75O16Na
CAS number: 119068-77-8
sodium salt of a monocarboxylic acid polyether ionophore produced by Actinomadura roseorufa (ATCC 53664)
Related impurities:
Descarboxylsemduramicin, ≤ 2 %
Desmethoxylsemduramicin, ≤ 2 %
Hydroxysemduramicin, ≤ 2 %
Total: ≤ 5 % Chickens for fattening — 20 25 Use prohibited at least five days before slaughter.Simultaneous use of semduramicin and tiamulin may induce a temporary reduction of feed consumption and water intake. 10 years from the date to entry into force of Regulation
ANNEX III

EC No Additive Chemical formula, description Species or category of animal Maximum age Maximum content mg/kg of complete feedingstuff Other provisions End of period of authorisation
Vitamins, provitamins and chemically well defined substances having similar effect
 2. Vitamin D      
E 670 a 25-hydroxycholecalciferol 25-hydroxycholecalciferol(minimum 94 % purity) Chickens for fattening — 0,1 mg The mixture of 25-hydroxylcholecalciferol with vitamin D3 (cholecalciferol) is allowed, provided that the total amount of the mixture does not exceed 0,125 mg/kg complete feedingstuff Without a time limit
Laying hens — 0,08 mg The mixture of 25-hydroxylcholecalciferol with vitamin D3 (cholecalciferol) is allowed, provided that the total amount of the mixture does not exceed 0,080 mg/kg complete feedingstuff Without a time limit
Turkeys — 0,1 mg The mixture of 25-hydroxylcholecalciferol with vitamin D3 (cholecalciferol) is allowed, provided that the total amount of the mixture does not exceed 0,125 mg/kg complete feedingstuff. Without a time limit
