Commission Regulation (EC) No 654/2000 of 29 March 2000 concerning the authorisation of new additives, new additive uses and new additive preparations in feedingstuffs (Text with EEA relevance)
L 79/26 EN Official Journal of the European Communities 30. 3. 2000 COMMISSION REGULATION (EC) No 654/2000 of 29 March 2000 concerning the authorisation of new additives, new additive uses and new additive preparations in feedingstuffs (Text with EEA relevance) 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 Commission Regulation (EC) No 2690/1999 (2) and in particular Article 3 thereof, Whereas: (1) (2) (3) (4) Directive 70/524/EEC provides that new additives or new additive uses shall be authorised, taking account of advances in scientific and technical knowledge. Council Directive 93/113/EC of 14 December 1993 concerning the use and the marketing of enzymes, micro-organisms and their preparations in animal nutri- tion (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 prepa- rations. New data were submitted for the replacement of author- ised preparations of enzymes by new preparations of the same enzymes. A provisional authorisation of new additives or new uses of additives shall be given if, at the level permitted in it does not adversely affect human or feedingstuffs, the environment, nor harm the animal health or consumer by altering the characteristics of livestock can be in feedingstuffs products, controlled, and it is reasonable to assume, in view of the available results, that it has a favourable effect on the characteristics of those feedingstuffs or on livestock production when incorporated in such feedingstuffs. its presence if (5) Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (5) and its (1) OJ L 270, 14. 12. 1970, p. 1. (2) OJ L 326, 18. 12. 1999, p. 33. (3) OJ L 334, 31. 12. 1993, p. 17. (4) OJ L 180, 9. 7. 1997, p. 21. (5) OJ L 183, 29. 6. 1989, p. 1. individual directives, in particular Council relevant Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (6), as last amended by Commission Directive 75/65/EC (7), are fully applicable to the use and manipulation by workers of the additives in feedingstuffs. (6) (7) (8) 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 prepara- tions belonging to the groups of enzymes and micro- organisms can be provisionally authorised. The Scientific Committee for Animal Nutrition has deliv- ered a favourable opinion with regard to the harmless- ness of these enzyme (8) and micro-organism (9) prepara- tions. The measures provided for in this Regulation 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’ listed in Annex I to the present Regulation shall be authorised according to Directive 70/524/EEC as additives in animal nutrition under the conditions laid down in the said Annex. Article 2 The particulars concerning the composition of the enzymes authorised under Nos ‘7’ and ‘8’ are modified, as indicated in Annex I, under the heading ‘Chemical formula, description’. Article 3 The preparations belonging to the group ‘Micro-organisms’ listed in Annex II to the present Regulation shall be authorised according to Directive 70/524/EEC as additives in animal nutri- tion under the conditions laid down in the said Annex. (6) OJ L 374, 31. 12. 1990, p. 1. (7) OJ L 335, 6. 12. 1997, p. 17. (8) Report of the Scientific Committee for Animal Nutrition on the use of certain enzymes as additives in feedingstuffs, adopted on 4 June 1998, updated on 21 October 1999. (9) Report of the Scientific Committee for Animal Nutrition on the use of certain micro-organismes as additives in feedingstuffs, adopted on 26 September 1997, updated on 22 October 1999. 30. 3. 2000 EN Official Journal of the European Communities L 79/27 This Regulation shall enter into force on the third day following publication in the Official Journal of the European Communities. Article 4 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 29 March 2000. For the Commission David BYRNE Member of the Commission No Additive Chemical formula, description Species or category of animal ANNEX I Maximum age Minimum content Maximum content Other provisions 4 7 Endo-1,3(4)-beta- glucanase EC 3. 2. 1. 6 Preparation of endo-1,3 (4)- beta-glucanase proudced by Aspergillus (CBS 589. 94) having a minimum activity of: aculeatus Chickens for fattening — Coated form: 50 FBG (1)/g Liquid form: 120 FBG/ml Units of activity per kg of complete feedingstuff Endo-1,3(4)-beta- glucanase Endo-1,3(4)-beta- glucanase: 10 FBG 100 FBG Endo-1,4-beta- xylanase EC 3. 2. 1. 8 Endo-1,4-beta- glucanase EC 3. 2. 1. 4 Preparation of endo-1,4-beta- xylanase and endo-1,4-beta- glucanase produced by Asper- gillus 600. 94) having a minimum activity of: (CBS niger Coated form: 36 000 FXU (2)/g 15 000 BGU (3)/g Liquid form: 36 000 FXU/g 15 000 BGU/g Chicken for fattening — Endo-1,4-beta- xylanase: 3 600 FXU Endo-1,4-beta- xylanase: 12 000 FXU Endo-1,4-beta- glucanase: Endo-1,4-beta- glucanase: 1 500 BGU 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. Recommended dose per kilogram of complete feedingstuff: Endo-1,3(4)-beta-glucanase: 20 FBG 3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans), e. g. containing more than 60 % maize. 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: Endo-1,4-beta-xylanase: 3 600-6 000 FXU Endo-1,4-beta-glucanase: 1 500-2 500 BGU 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e. g. containing more than 35 % barley and 20 % wheat. Period of authorisation 30. 11. 2000 30. 11. 2000 L 7 9 / 2 8 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. 3 0 3 2 0 0 0 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 Piglets four months Endo-1,4-beta- xylanase: 6 000 FXU Endo-1,4-beta- glucanase: 2 500 BGU — — Turkeys for fattening — Endo-1,4-beta- xylanase: 6 000 FXU Endo-1,4-beta- xylanase: 12 000 FXU Endo-1,4-beta- glucanase: Endo-1,4-beta- glucanase: 2 500 BGU 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. Recommended dose per kilogram of complete feedingstuff: Endo-1,4-beta-xylanase: 6 000 FXU Endo-1,4-beta-glucanase: 2 500 BGU 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e. g. containing more than 30 % wheat and 30 % 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 kilogram of complete feedingstuff: Endo-1,4-beta-xylanase: 6 000-12 000 FXU Endo-1,4-beta-glucanase: 2 500-5 000 BGU 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e. g. containing more than 40 % wheat. Period of authorisation 30. 11. 2000 30. 11. 2000. 3 0 3 2 0 0 0 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 7 9 / 2 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 Laying hens — Endo-1,4-beta- xylanase: 12 000 FXU Endo-1,4-beta- glucanase: 5 000 BGU — — 8 Endo-1,4-beta- glucanase EC 3. 2. 1. 4 Endo-1,4-beta- xylanase EC 3. 2. 1. 8 Preparation of Endo-1,4-beta- glucanase and Endo-1,4-beta- xylanase proudced Aspergillus niger (CBS 600. 94) having a minimum activity of: Coated form: 10 000 BGU (3)/g 4 000 FXU (2)/g Liquid form: 20 000 BGU/g 8 000 FXU/g Chickens for fattening — Endo-1,4-beta- glucanase: 3 000 BGU Endo-1,4-beta- glucanase: 10 000 BGU Endo-1,4-beta- xylanase: Endo-1,4-beta- xylanase: 1 200 FXU 4 000 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 kilogram of complete feedingstuff: Endo-1,4-beta-xylanase: 12 000 FXU Endo-1,4-beta-glucanase: 5 000 BGU 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e. g. containing more than 20 % wheat, 10 % barley and 20 % sunflower. 1. In the directions for use of the additive and premixture, inidcate the storage temperature, storage life, and stability to pelleting. 2. Recommended dose per kilogram of complete feedingstuff: Endo-1,4-beta-glucanase: 3 000-10 000 BGU Endo-1,4-beta-xylanase: 1 200-4 000 FXU 3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e. g. containing more than 60 % barley. Period of authorisation 30. 11. 2000 30. 11. 2000 L 7 9 / 3 0 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. 3 0 3 2 0 0 0 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 Piglets Four months Endo-1,4-beta- glucanase: Endo-1,4-beta- glucanase: 3 000 BGU 5 000 BGU Endo-1,4-beta- xylanase: Endo-1,4-beta- xylanase: 1 200 FXU 2 000 FXU Laying hens — Endo-1,4-beta- glucanase: 5 000 BGU Endo-1,4-beta- xylanase: 2 000 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 kilogram of complete feedingstuff: Endo-1,4-beta-glucanase: 3 000-5 000 BGU Endo-1,4-beta-xylanase: 1 200-2 000 FXU 3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e. g. containing more than 30 % 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 kilogram of complete feedingstuff: Endo-1,4-beta-glucanase: 5 000 BGU Endo-1,4-beta-xylanase: 2 000 FXU 3. For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e. g. containing more than 60 % barley. Period of authorisation 30. 11. 2000 30. 11. 2000. 3 0 3 2 0 0 0 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 7 9 / 3 1 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 9 Endo-1,4-beta- xylanase EC 3. 2. 1. 8 Preparation of Endo-1,4-beta- yxlanase produced by Asper- 270. 95) gillus having a minimum activity of: (CBS niger Solid form: Endo-1,4-beta-xylanase: 28 000 EXU (4)/g Liquid form: Endo-1,4-beta-xylanase: 14 000 EXU/ml Laying hens — Endo-1,4-beta- xylanase: 2 400 EXU Turkeys for fattening — Endo-1,4-beta- xylanase: 2 400 EXU — — 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: 2 400 - 7 400 EXU 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans) e. g. conta- nining more than 30 % wheat and 30 % rye. 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: 2 400-5 600 EXU 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans) containing more than 30 % wheat and 30 % rye. e. g. Period of authorisation 30. 11. 2000 30. 11. 2000 L 7 9 / 3 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. 3 0 3 2 0 0 0 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 — Endo-1,3(4)-beta- glucanase: 600 BGU Endo-1,4-beta- xylanase: 800 FXU 13 Endo-1,3(4)-beta- glucanase EC 3. 2. 1. 6 Endo-1,4-beta- xylanase EC 3. 2. 1. 8 Laying hens Preparation of Endo-1,3(4)- beta-glucanase and Endo-1,4- by beta-xylanase produced longibrachiatum Trichoderma (CBS a having 357. 94) minimum activity of: Powder form: Endo-1,3(4)-beta-glucanase: 8 000 BGU (5)/g Endo-1,4-beta-xylanase: 11 000 EXU (4)/g Granulated form: Endo-1,3(4)-beta-glucanase: 6 000 BGU/g Endo-1,4-beta-xylanase: 8 250 EXU/g Liquid form: Endo-1,3(4)-beta-glucanase: 2 000 BGU/ml Endo-1,4-beta-xylanase: 2 750 EXU/ml Turkeys for fattening — Endo-1,3(4)-beta- glucanase: 600 BGU Endo-1,4-beta- xylanase: 800 EXU — — — — Period of authorisation 30. 11. 2000 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: 600 BGU Endo-1,4-beta-xlanase 800 EXU 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e. g. containing more than 40 % wheat and more than 30 % barley. 30. 11. 2000 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: 600 BGU Endo-1,4-beta-xylanase: 800 EXU 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e. g. containing more than 30 % wheat or more than 30 % rye. 3 0 3 2 0 0 0 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 7 9 / 3 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 48 Alpha-amylase EC 3. 2. 1. 1 Endo-1,3(4)-beta- glucanase EC 3. 2. 1. 6 Preparation of Alpha-amylase Endo-1,3(4)-beta-gluca- and by Bacillus produced nase amyloliquefaciens (DSM 9553) having a minimum activity of: Coated form: Alpha-amylase: 200 KNU (6)/g Endo-1,3(4)-beta-glucanase: 350 FBG (1)/g Liquid form: Alpha-amylase: 130 KNU/ml Endo-1,3(4)-beta-glucanase: 225 FBG/ml Chickens for fattening — Alpha-amylase: Alph-amylase: 10 KNU 40 KNU 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Endo-1,3(4)-beta- glucanase: Endo-1,3(4)-beta- glucanase: 2. Recommended dose per kg of complete feedingstuff: 17 FBG 70 FBG Turkeys for fattening — Alpha-amylase: Alpha-amylase: 40 KNU 80 KNU Endo-1,3(4)-beta- glucanase: Endo-1,3(4)-beta- glucanase: 70 FBG 140 FBG Alpha-amylase: 20 KNU Endo-1,3(4)-beta-glucanase: 35 FBG 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e. g. containing more than 40 % 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: Alpha-amylase: 40 KNU Endo-1,3(4)-beta-glucanase: 70 FBG 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans) and beta-glucans), e. g. containing more than 40 % barley. (1) One FBG is the amount of enzyme which liberates one micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 5,0 and 30 °C. (2) One FXU is the amount of enzyme which liberates 0,15 micromole of xylose from azurine-cross-linked xylan per minute at pH 5,0 and 40 °C. (3) One BGU is the amount of enzyme which liberates 0,15 micromoles of glucose from azurine-cross-linked beta-glucan per minute at pH 5,0 and 40 °C. (4) One EXU is the amount of enzyme which liberates one micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °C. (5) One BGU is the amount of enzyme which liberates 0,278 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 3,5 and 40 °C. (6) One KNU is the amount of enzyme which liberates 672 micromoles of reducing sugars (glucose equivalent) from soluble starch per minute at pH 5,6 and 37 °C. Period of authorisation 30. 11. 2000 30. 11. 2000 L 7 9 / 3 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. 3 0 3 2 0 0 0 ANNEX II CFU/kg of complete feedingstuff No Additive Chemical formula, description Species or category of animal Maximum age Minimum content 11 Enterococcus faecium DSM 5464 Preparation of Enterococcus a faecium minimum of: 5 × 1010 CFU/g additive containing Chickens for fattening — 0,5 × 109 Maximum content 1 × 109 Calves four months 0,5 × 1010 1 × 109 17 Lactobacillus casei NCIMB 30096 Mixture of Lactobacillus casei and faecium Enterococcus containing a minimum of: Calves Enterococcus faecium NCIMB 30098 Lactobacillus casei 20 × 109 CFU/g and: six months Lactobacillus casei 0,5 × 109 Lactobacillus casei 1 × 109 Enterococcus faecium 1,5 × 109 Enterococcus faecium 3 × 109 18 Enterococcus faecium CECT 4515 Enterococcus faecium 6 × 109 CFU/g additive Preparation of Enterococcus faecium containing a mini- mum of 1 × 1010 CFU/g additive Piglets four months 1 × 109 1 × 109 Calves six months 1 × 109 1 × 109. 3 0 3 2 0 0 0 Other provisions Period of authorisation 1. In the directions for use of additive and premixture, the storage temperature, life and stability to pelleting. the indicate storage 2. May be used in compound feed containing the permitted coccidio- stats: amprolium, diclazuril, halofu- ginone, monensin-sodium, metil- clorpindol, methylbenzoquate, nicarbazin. and premixture, In the directions for use of the addi- tive the storage temperature, storage life and stability to pelleting. indicate and premixture In the directions for use of the addi- tive the storage temperature storage life and stability to pelleting. indicate and premixture In the directions for use of the addi- tive the storage temperature, storage life and stability to pelleting. indicate and premixture In the directions for use of the addi- tive the storage temperature, storage life and stability to pelleting. indicate 30. 11. 2000 E N 30. 11. 2000 30. 11. 2000 30. 11. 2000 30. 11. 2000 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 7 9 / 3 5