Commission Regulation (EC) No 866/1999 of 26 April 1999 concerning the authorisation of new additives and new additive uses in feedingstuffs
27. 4. 1999 EN Official Journal of the European Communities L 108/21 COMMISSION REGULATION (EC) No 866/1999 of 26 April 1999 concerning the authorisation of new additives and new additive uses in feeding- stuffs THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Directive 1999/20/EC (2), and in particular Articles 3 and 9j thereof, (1) Whereas Directive 70/524/EEC provides that new additives or new additive uses may be authorised, taking account of advances in scientific and tech- nical knowledge; (2) Whereas Council Directive 93/113/EC of 14 December 1993 concerning the use and the marketing of enzymes, micro-organisms and their preparations in animal nutrition (3), as last amended by Directive 97/40/EC (4), by derogation from Directive 70/524/EEC, authorised Member States to permit provisionally the use and marketing of enzymes, micro-organisms and their preparations; (3) Whereas the examination of the dossiers, submitted by the Member States in accordance with Article 3 of Directive 93/113/EC, indicates that a certain number of preparations belonging to the groups of enzymes and micro-organisms can be provisionally authorised; (4) Whereas the Scientific Committee for Animal Nutrition has delivered a favourable opinion with regard to the harmlessness of these preparations; (5) Whereas the measures provided for in this Regula- tion are in accordance with the opinion of the Standing Committee on Feedingstuffs, HAS ADOPTED THIS REGULATION: Article 1 The preparations belonging to the group ‘enzymes' and listed in Annex I to this Regulation may be authorised according to Directive 70/524/EEC as additives in animal nutrition under the conditions laid down in that Annex. Article 2 The preparations belonging to the group ‘micro-orga- nisms' and listed in Annex II to this Regulation may be authorised according to Directive 70/524/EEC as addi- tives in animal nutrition under the conditions laid down in that Annex. Article 3 This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. It shall apply from 1 July 1999. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 26 April 1999. For the Commission Franz FISCHLER Member of the Commission (1) OJ L 270, 14. 12. 1970, p. 1. (2) OJ L 80, 25. 3. 1999, p. 20. (3) OJ L 334, 31. 12. 1993, p. 17. (4) OJ L 180, 9. 7. 1997, p. 21. No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Units of activity per kg of complete feedingstuff Other provisions ANNEX I 2 3-phytase EC 3. 1. 3. 8 Preparation of 3-phytase produced by Aspergillus oryzae (DSM 10 289) having a minimum activity of: Coated form: 2 500 FYT (1)/g Liquid form: 5 000 FYT/g Laying hens ü 500 FYT 1 000 FYT Piglets Four months 3 000 BGU 1 200 FXU 5 000 BGU 2 000 FXU 8 Endo-1,4-betaglucan- ase EC 3. 2. 1. 4 Endo-1,4-betaxylana- se EC 3. 2. 1. 8 and Preparation of endo-1,4-beta-gluca- nase endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 600. 94) having a minimum activity of: Solid and liquid forms: Endo-1,4-beta-glucanase: 10 000 BGU (2)/g Endo-1,4-beta-xylanase: 4 000 FXU (3)/g 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: 750 FYT. e. g. 3. For use in compound feed rich in containing more phytates, than 40 % cereals (corn, barley, oats, wheat, rye, triticale), oilseeds and pulses. 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: 3 000 to 5 000 BGU 1 200 to 2 000 FXU. non-starch 3. For use in compound feed rich in polysaccharides (mainly beta-glucans and arabi- noxylans), e. g. containing more than 30 % barley. Period of authorisation 30. 9. 1999 30. 9. 1999 L 1 0 8 / 2 2 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s 2 7. 4. 1 9 9 9 No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Units of activity per kg of complete feedingstuff Other provisions 29 Endo-1,3(4)-beta- glucanase EC 3. 2. 1. 6 of Preparation endo-1,3(4)-beta- glucanase produced by Geosmithia emersonii (IMI SD 133) having a minimum activity of: Chickens fattening 5 500 U (4)/g for ü 250 U ü Chickens fattening for ü ü Endo-1,3(4)- beta-gluca- nase: 100 U Endo-1,4- beta-xyla- nase: 70 U 30 Endo-1,3(4)-beta- glucanase EC 3. 2. 1. 6 Endo-1,4-beta-xyla- nase EC 3. 2. 1. 8 of Preparation endo-1,3(4)-beta- glucanase and endo-1,4-beta-xyla- nase produced by Penicillium funi- culosum (IMI SD 101) having a minimum activity of: Powder form Endo-1,3(4)-beta-glucanase: 2 000 U (5)/g Endo-1,4-beta-xylanase: 1 400 U (6)/g Liquid form Endo-1,3(4)-beta-glucanase: 500 U/ ml Endo-1,4-beta-xylanase: 350 U/ml 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 U. non-starch 3. For use in compound feed rich in polysaccharides. (mainly beta-glucans), e. g. con- taining more than 50 % barley. 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 U Endo-1,4-beta-xylanase: 70 U. non-starch 3. For use in compound feed rich in polysaccharides, (mainly beta-glucans and arabi- noxylans), e. g. containing more than 50 % barley or 60 % wheat. Period of authorisation 30. 9. 1999 30. 9. 1999 2 7. 4. 1 9 9 9 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 0 8 / 2 3 No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Units of activity per kg of complete feedingstuff Other provisions 31 Endo-1,4-betaxyla- nase EC 3. 2. 1. 8 Preparation of endo-1,4-beta-xyla- nase produced by Trichoderma longibrachiatum (CBS 614-94) having a minimum activity of: Chickens fattening for ü 600 EU ü Solid form: 300 EU (7)/g Liquid form: 1 000 EU/g 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: 600 EU. non-starch 3. For use in compound feed rich polysaccharides e. g. 60 % in (mainly containing more wheat. arabinoxylans), than Laying hens ü 300 EU ü 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: 600 EU. non-starch 3. For use in compound feed rich polysaccharides in (mainly arabinoxylans), e. g. con- taining more than 60 % wheat. (1) One FYT is the amount of enzyme which liberates one micromole of inorganic phosphate per minute using Na-phytate as substrate at pH 5,5 and 37 °C. (2) One BGU is the amount of enzyme which liberates 0,15 micromoles of glucose per mintue from azurine-crosslinked beta-glucan at pH 5,0 and 40 °C (3) One FXU is the amount of enzyme which liberates 0,15 micromoles of xylose per minute from azurine-crosslinked xyland at pH 5,0 y and at 40 °C (4) One U is the amount of enzyme which liberates 2,78 micromoles of reducing sugars (maltose equivalents) from barley beta-glucan per minute at pH 5,0 and 50 °C (5) One 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 (6) One 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 (7) One EU is the amount of enzyme which liberates one micromole of reducing sugars (xylose equivalents) from oat xylan per minute at pH 4,5 and 40 °C Period of authorisation 30. 9. 1999 30. 9. 1999 L 1 0 8 / 2 4 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s 2 7. 4. 1 9 9 9 ANNEX II No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content CFU/kg of complete feedingstuff Other provisions Period of author- isation 5 9 Saccharomyces visiae CBS 493. 94 cere- Preparation of Saccharomyces ce- revisiae containing a minimum of 1 ·10 8 CFU/g additive Cattle for fattening ü 1,7 · 108 1,7 · 108 Pediococcus acidilac- tici CNCM MA 18/5M Preparation of Pediococcus acidilac- containing a minimum of tici 1 · 1010 CFU/g of additive Chickens for fattening ü 1 · 109 1 · 1010 Piglets Four months 1 · 109 1 · 109 Pigs ü 1 · 109 1 · 109 30. 9. 1999 30. 9. 1999 In the directions for use of the addi- tive and premixture, indicate the storage temperature, storage life and stability to pelleting. The quantity of Saccharomyces cere- visiae in the daily ration must not exceed 100 kg body weight. Add 1 · 108 CFU for each extra 100 kg body weight. 7,5 · 108 CFU for In the directions for use of the addi- indicate the tive and premixture, storage temperature, storage life and stability to pelleting. May be used in compound feed containing the permitted coccidio- stats: amprolium, meticlorpindol, decoquinate, halofuginone, narasin, salinomycin nicarbazin, sodium, maduramicin ammonium, diclazuril. In the directions for use of the addi- tive and premixture, indicate the storage temperature, storage life and stability to pelleting. 30. 9. 1999 In the directions for use of the addi- tive and premixture, indicate the storage temperature, storage life and stability to pelleting. 30. 9. 1999 2 7. 4. 1 9 9 9 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 0 8 / 2 5 No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content CFU/kg of complete feedingstuff Other provisions Period of author- isation 10 Enterococcus faecium NCIMB 10415 Preparation of Enterococcus faecium containing a minimum of: Chickens for fattening ü 0,3 · 109 2,8 · 109 Microencapsulated form: 1,0 · 1010 CFU/g additive 1,75 · 1010 CFU/g additive Pigs ü 0,35 · 109 1,5 · 109 30. 9. 1999 In the directions for use of the addi- tive and premixture, indicate the storage temperature, storage life and stability to pelleting. May be used in compound feed containing the permitted coccidio- stats: amprolium, amprolium/ethopa- bate, diclazuril, halofuginone, madur- amicin ammonium, meticlorpindol, meticlorpindol/methylbenzoquate, monensin sodium, robenidine, sal- inomycin sodium In the directions for use of the addi- tive and premixture, indicate the storage temperature, storage life and stability to pelleting. 30. 9. 1999 Sows ü 0,2 · 109 1,25 · 109 In the directions for use of the addi- tive and premixture, indicate the storage temperature, storage life and stability to pelleting. 30. 9. 1999 Cattle for fattening ü 0,25 · 109 0,6 · 109 In the directions for use of the addi- tive and premixture, indicate the storage temperature, storage life and stability to pelleting. 30. 9. 1999 of quantity The Enterococcus faecium in the daily ration must not exceed 100 kg body weight. Add 1 · 109 CFU for each additional 100 kg body weight. 1 · 109 CFU for L 1 0 8 / 2 6 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s 2 7. 4. 1 9 9 9 No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content CFU/kg of complete feedingstuff Other provisions Period of author- isation Preparation of Enterococcus faecium containing a minimum of: Piglets Four months 0,3 · 109 1,4 · 109 Microencapsulated form: 1,0 · 1010 CFU/g additive 1,75 · 1010 CFU/g additive and Granulated form: 3,5 · 1010 CFU/g additive Calves Six months 0,35 · 109 6,6 · 109 11 Enterococcus um DSM 5464 faeci- Preparation of Enterococcus faecium containing a minimum of: 5 · 1010 CFU/g additive Piglets Four months 0,5 · 109 1 · 109 In the directions for use of the addi- tive and premixture, indicate the storage temperature, storage life and stability to pelleting. Granulated form to be used exclu- sively in milk replacers. In the directions for use of the addi- tive and premixture, indicate the storage temperature, storage life and stability to pelleting. Granulated form to be used exclu- sively in milk replacers. In the directions for use of the addi- tive and premixture, indicate the storage temperature, storage life and stability to pelleting. 30. 9. 1999 30. 9. 1999 30. 9. 1999 2 7. 4. 1 9 9 9 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 0 8 / 2 7