Commission Regulation (EC) No 2786/98 of 22 December 1998 concerning the modification of the period of authorisations of additives referred to in Article 9i(1) of Council Directive 70/524/EEC
23. 12. 98 EN Official Journal of the European Communities L 347/25 COMMISSION REGULATION (EC) No 2786/98 of 22 December 1998 concerning the modification of the period of authorisations of additives referred to in Article 9i(1) 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 Regulation (EC) No 2785/98 (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 9i(1) of Directive 70/524/EEC and transferred to Chapter III of Annex B to this Directive which can accordingly be authorised provisionally at national level until 30 November 1998 has not yet been completed; whereas, therefore, the period of authorisation of these substances should be extended for a determined period; Whereas the Commission has consulted the Scientific Committee for animal nutrition concerning the author- isation of the antibiotics and the coccidiostats included in this the Annex to the present Regulation; whereas Committee delivered an opinion with regard to the effi- cacy, the safety and the controllability of these substances; 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 Chapter III of Annex B to Directive 70/524/EEC is amended in accordance with the Annex to this Regula- tion. 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) See page 21 of this Official Journal. Chapter III of Annex B to Directive 70/524/EEC is amended as follows: Additives linked to a person responsible for marketing, inserted in Annex II before 1 April 1998 ANNEX A. Antibiotics Registra- tion number Name and registration number of person responsible for marketing (1) Additive Chemical formula, description Species or category of animal Maximum age ‘31 33 Bacitracin zinc Avilamycin Chickens tening Pigs Turkeys for fat- — 6 months — 66 16 103 O H N SZn C 17 (polypeptide containing 12 to 20 % zinc) O 82. 90 57. 62 31. 32 H Cl C 1. 2 (mixture of oligosacchar- the orthosomycin ides of group produced by Strepto- myces viridochromogenes, NRRL 2860) Factor composition: — Avilamycin A: not less than 60 % — Avilamycin B: more than 18 % not — Avilamycins A+B: not less than 70 % — Other single avilamy- than cins: not more 6 % Minimum content Maximum content mg/kg complete feedingstuff 5 5 5 50 50 10 Other provisions Duration of authorisation — — — 17. 7. 1999 (2) 17. 7. 1999 (2) 30. 9. 1999 (3)' L 3 4 7 / 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 3. 1 2. 9 8 B. Cooccidiostats and other medicinal substances Name and registration number of person responsible for marketing (1) Registra- tion number ‘26 Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content mg/kg complete feedingstuff Other provisions Duration of authorisation Salinomycin dium so- 69 42 11 O H Na C (sodium salt of a polyether monocarboxylic acid pro- Streptomyces duced albus) by Rabbits tening for fat- — 20 25 Use prohibited at least five days before slaughter. 30. 9. 1999 (4) Elaiophylin content: less than 42 mg per kg of sali- nomycin sodium 17-epi-20-desoxysalino- mycin content: than 40 g per kg of salinomycin sodium less Chickens reared for laying 12 weeks 30 50 Indicate in the instruc- tions for use: — “Dangerous for equi- nes” — “This feedingstuff con- an ionophore; tains simultaneous use with certain medicinal sub- stances (e. g. tiamulin) can be contra indic- ated” Indicate in the instruc- tions for use: — “Dangerous for equi- nes” — “This feedingstuff con- tains an ionophore; simultaneous use with certain medicinal sub- tiamulin) stances (e. g. can be contra indic- ated” 30. 9. 1999 (5) 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 7 Registra- tion number Name and registration number of person responsible for marketing (1) 27 28 C. Growth promoters Name and registration number of person responsible for marketing (1) Registra- tion number ‘— Additive Chemical formula, description Species or category of animal Maximum age Diclazuril (5)-4-chlorphenyl(2,6-diclo- ro-4-(2,3,4,5-tetrahydro-3,5- dioxo-1,2,4-triazin-2yl-phe- nyl)acetonitrile Maduramycin am- monium 47 83 17 O H N C (ammonium salt of a poly- ether monocarboxylic acid produced by Actinoma- dura yumaensis) Turkeys 12 weeks Chickens reared for laying 16 weeks Turkeys 16 weeks Minimum content Maximum content mg/kg complete feedingstuff 1 1 5 1 1 5 Other provisions Duration of authorisation Use prohibited at least five days before slaughter. 30. 9. 1999 (4) — 30. 9. 1999 (3) 30. 9. 1999 (5)' Use prohibited at least five days before slaughter. Indicate in the instruc- tions for use: — “Dangerous for equi- nes” — “This feedingstuff con- tains an ionophore; simultaneous use with certain medicinal sub- stances (e. g. tiamulin) can be contra indic- ated” Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content mg/kg complete feedingstuff Other provisions Duration of authorisation — — — — — — — —' (1) Authorisation linked to the person responsible with effect from 1 October 1999. (2) First authorisation 18 July 1994, Commission Directive 94/41/EC (OJ L 209, 12. 8. 1994, p. 18). (3) First authorisation 15 December 1997, Commission Directive 97/72/EC (OJ L 351, 23. 12. 1997, p. 55). (4) First authorisation 21 February 1996, Commission Directive 96/7/EC (OJ L 51, 1. 3. 1996, p. 45). (5) First authorisation 14 October 1996, Commission Directive 96/66/EC (OJ L 272, 25. 10. 1996, p. 32). L 3 4 7 / 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 2 3. 1 2. 9 8