Commission Regulation (EC) No 2785/98 of 22 December 1998 concerning the modification of the period of authorisations of additives referred to in Article 9e(3) of Council Directive 70/524/EEC
23. 12. 98 EN Official Journal of the European Communities L 347/21 COMMISSION REGULATION (EC) No 2785/98 of 22 December 1998 concerning the modification of the period of authorisations of additives referred to in Article 9e(3) of Council Directive 70/524/EEC 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 Directive 98/19/EC (2), and in particular Articles 9j and 3 thereof, Whereas Directive 70/524/EEC provides that new addi- tives or uses of additives may be authorised, taking account of advances in scientific and technical know- ledge; the level permitted in feedingstuffs, Whereas a provisional authorisation of new additives or uses of additives may be given for a period of five years, if, at it does not adversely affect human or animal health or the environ- ment, nor harm the consumer by altering the characteris- tics of livestock product, if its presence in feedingstuffs can be 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; Whereas research into various additives referred to in Article 9e(3) of Directive 70/524/EEC which can be level until 30 authorised provisionally at national November 1998 has not yet been completed; whereas, therefore, the period of authorisation of these substances should be extended taking into account that the period of provisional authorisation of these additives can not exceed five years; Whereas the Commission has consulted the Scientific Committee for animal nutrition concerning the author- isation of the micro-organisms included in the Annex to the present Regulation; whereas this Committee delivered an opinion in particular with regard to the safety of these additives; Whereas the measures provided for in this Regulation are the Standing in accordance with the opinion of Committee on Feedingstuffs, HAS ADOPTED THIS REGULATION: Article 1 Additives referred to in the Annex to this Regulation may be authorised in accordance with Directive 70/524/EEC under the conditions laid down in this Annex. Article 2 This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Communities. It shall apply with effect from 1 December 1998. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 22 December 1998. For the Commission Franz FISCHLER Member of the Commission (1) OJ L 270, 14. 12. 1970, p. 1. (2) OJ L 96, 28. 3. 1998, p. 39. ANNEX Binders, anti-caking agents and coagulants Registration number Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content mg/kg of complete feedingstuff Other provisions Duration of authorisation 2 Natrolite-phonolite Natural mixture of aluminium sili- cates, alkalines and alkaline-earth and aluminium hydrosilicates, na- trolite (43 to 46,5 %) and feldspar All animal species and categories — — 25 000 All feedingstuffs 21. 4. 1999 (1) Registration number Additive Chemical formula, description Species or category of animal Maximum age CFU/kg of complete feedingstuffs Minimum Maximum Other provisions Micro-organisms 1 2 3 Bacillus cereus var. toy- oi (CNCM I-1012/ NCIB 40112) Preparations of Bacillus cereus var. toyoi containing a minimum 1010 CFU/g additive licheniformis Bacillus (DSM 5749)/Bacillus subtilis (DSM 5750) (in a 1/1 ratio) Mixture of Bacillus licheniformis and Bacillus subtilis containing a minimum 3,2 ý 109 CFU/g addi- tive (1,6 ý 109 CFU/g of each bac- teria) Saccharomyces siae (NCYC Sc 47) cerevi- Preparation of Saccharomyces cere- visiae a minimum 5 ý 109 CFU/g additive containing Pigs Sows Piglets Piglets 2 months 109 4 months 0,5 ý 109 6 months 0,2 ý 109 109 109 109 — 0,5 ý 109 2 ý 109 4 months 1,28 ý 109 3,2 ý 109 Cattle for fattening — 4 ý 109 8 ý 109 Duration of authorisation 21. 4. 1999 (1) 21. 4. 1999 (1) 21. 4. 1999 (1) 21. 4. 1999 (1) 17. 7. 1999 (2) 20. 2. 2001 (3) — — — — — Indicate in the instructions for use: ‘The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 2,5 ý 1010 CFU for 100 bodyweight; 0,5 ý 1010 CFU for each additional 100 kg of body- weight' kg of L 3 4 7 / 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 3. 1 2. 9 8 Registration number Additive Chemical formula, description Species or category of animal Maximum age CFU/kg of complete feedingstuffs Minimum Maximum Other provisions 4 Bacillus cereus (ATCC Preparation of Bacillus 14893/CIP 5832) cereus containing a minimum 1010 CFU/g additive Rabbits for fattening Breeding rabbits — — 0,5 ý 109 2 ý 109 0,5 ý 109 2 ý 109 — — (1) First authorisation 22 April 1994, Commission Directive 94/17/EC (OJ L 105, 26. 4. 1994, p. 19). (2) First authorisation 18 July 1994, Commission Directive 94/41/EC (OJ L 209, 12. 8. 1994, p. 18). (3) First authorisation 21 February 1996, Commission Directive 96/7/EC (OJ L 51, 1. 3. 1996, p. 45). 1. Radioactive caesium binders (137Cs and 134Cs): Radionuclide binders Registration number Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content mg/kg of complete feedingstuff Other provisions 1. 1 Ferric (III) ammonium hexacyanoferrat e (II) Fe(III)[(Fe(II)(CN) NH 6 4 )] Ruminants (domestic and wild) — 50 500 Calves prior start of rumination to the — 50 500 Lambs prior start of rumination to the — 50 500 Indicate in the instructions ‘The quantity of for use: Ferric ammonium (III) hexacyanoferrate (II) in the be ration must daily between 10 and 150 mg for 10 kg of body weight' Indicate in the instructions ‘The quantity of for use: Ferric ammonium (III) hexacyanoferrate (II) in the daily be ration must between 10 and 150 mg for 10 kg of body weight' Indicate in the instructions ‘The quantity of for use: ammonium (III) Ferric hexacyanoferrate (II) in the daily be ration must between 10 and 150 mg for 10 kg of body weight' Duration of authorisation 20. 2. 2001 (3) 20. 2. 2001 (3) Duration of authorisation 13. 10. 2001 (1) 13. 10. 2001 (1) 13. 10. 2001 (1) 2 3. 1 2. 9 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 L 3 4 7 / 2 3 Registration number Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content mg/kg of complete feedingstuff Other provisions Kids prior to the start of rumination — 50 500 (domestic and — 50 500 Pigs wild) Indicate in the instructions ‘The quantity of for use: Ferric ammonium (III) hexacyanoferrate (II) in the daily be ration must between 10 and 150 mg for 10 kg of body weight' Indicate in the instructions ‘The quantity of for use: Ferric ammonium (III) hexacyanoferrate (II) in the daily be ration must between 10 and 150 mg for 10 kg of body weight' (1) First authorisation 14 October 1996, Commission Directive 96/66/EC (OJ L 272, 25. 10. 1996, p. 32). Duration of authorisation 13. 10. 2001 (1) 13. 10. 2001 (1) L 3 4 7 / 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 3. 1 2. 9 8