Commission Regulation (EC) No 418/2001



{0>COMMISSION REGULATION (EC) No 418/2001 of 1 March 2001 concerning the authorisations of new additives and uses of additives in feedingstuffsUREDBA KOMISIJE (ES) št. 418/2001

z dne 1. marca 2001

o dovoljenju za nove dodatke in načine uporabe dodatkov v krmi(Text with EEA relevance)(Besedilo velja za EGP)THE COMMISSION OF THE EUROPEAN COMMUNITIES,KOMISIJA EVROPSKIH SKUPNOSTI JE –Having regard to the Treaty establishing the European Community,ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti,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 2697/2000(2), and in particular Article 4 thereof,ob upoštevanju Direktive Sveta 70/524/EGS z dne 23. novembra 1970 o dodatkih v krmi[1], kakor je bila nazadnje spremenjena z Uredbo Komisije (ES) št. 2697/2000[2], in zlasti člena 4 Direktive,Whereas:ob upoštevanju naslednjega:(1) Directive 70/524/EEC provides that new additives or uses of additives may be authorised following the review of an application made in accordance with article 4 of the Directive.(1) Direktiva 70/524/EGS predvideva, da se lahko novi dodatki ali načini uporabe dodatkov dovolijo po pregledu zahtevka, vloženega v skladu s členom 4 Direktive.(2) Article 9e(1) of the Directive provides that provisional authorisation of new additives or uses of additives may be given if the conditions of Articles 3a(b) to (e) of Directive 70/524/EEC are satifisfied and if its reasonable to assume, in view of the available results, that when used in animal nutrition it has one of the effects referred to in Article 2(a).(2) Člen 9e(1) Direktive določa, da se za nove dodatke ali načine uporabe dodatkov lahko izda začasno dovoljenje, če so izpolnjeni pogoji iz členov od 3a(b) do (e) Direktive 70/524/EGS in če lahko glede na razpoložljive rezultate domnevamo, da imajo enega od učinkov iz člena 2(a), kadar se uporabljajo v prehrani živali.Such provisional authorisation may be given for a period up to four years in the case of additives referred to in Part II of Annex C to the Directive.Tako začasno dovoljenje lahko velja za obdobje do štirih let v primeru dodatkov iz dela II Priloge C k Direktivi.(3) The assessment of dossiers submitted shows that the new micro-organism and enzyme preparations and the new uses of the micro-organism and enzyme preparations described in Annex I and II satisfy the abovementioned conditions and may therefore be authorised on a provisional basis for a four-year period.(3) Glede na oceno predložene dokumentacije novi pripravki iz mikroorganizmov in encimov ter novi načini uporabe pripravkov iz mikroorganizmov in encimov, opisanih v Prilogi I in II, izpolnjujejo zgoraj navedene pogoje in jim je zato mogoče izdati začasno dovoljenje za obdobje štirih let.(4) Article 2(aaa) of Directive 70/524/EEC requires authorisations for coccidiostats to be linked to the person responsible for putting them into circulation.(4) Člen 2(aaa) Direktive 70/524/EGS zahteva, da so dovoljenja za kokcidiostatike povezana z osebo, ki je odgovorna za njihovo dajanje v promet.(5) Article 9b of Directive 70/524/EEC provides that the authorisations of such substances shall be given for a period of 10 years from the date on which final authorisation takes effect, if all conditions laid down in Article 3a of Directive 70/524/EEC are met.(5) Člen 9b Direktive 70/524/EGS določa, da se dovoljenja za take snovi dajejo za obdobje 10 let od datuma, ko začne veljati dokončno dovoljenje, če so izpolnjeni vsi pogoji, določeni v členu 3a Direktive 70/524/EGS.(6) The assessment of the dossier submitted shows that the coccidiostat described in Annex III satisfies all the requirements of Article 3a, when used in the anidmal category and under the conditions described in the said Annex.(6) Glede na oceno predložene dokumentacije kokcidiostatiki, opisani v Prilogi III, izpolnjujejo vse zahteve člena 3a, kadar se uporabljajo pri kategoriji živali in pod pogoji, opisanimi v navedeni prilogi.(7) The assessment of the dossiers shows that certain procedures may be required to protect workers from exposure to the additives.(7) Glede na predloženo dokumentacijo so potrebni nekateri postopki za zaščito delavcev pred izpostavljenostjo dodatkom.Such protection should however be assured by the application of 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(3) and the Directives made under it.Vendar pa mora biti takšna zaščita zagotovljena z uporabo Direktive Sveta 89/391/EGS z dne 12. junija 1989 o uvedbi ukrepov za spodbujanje izboljšav za varnost in zdravje delavcev pri delu[3] in nadaljnjih posamičnih direktiv.(8) The Scientific Committee for Animal Nutrition has delivered a favourable opinion with regard to the harmlessness of the enzyme and micro-organism preparations and of the coccidiostat, and with regard to the favourable effect on animal production of the latter, under the conditions described in the said Annexes.(8) Znanstveni odbor za prehrano živali je podal pozitivno mnenje v zvezi z neškodljivostjo pripravkov iz encimov in mikroorganizmov in iz kokcidiostatika ter v zvezi z ugodnim učinkom kokcidiostatika na živinorejsko proizvodnjo pod pogoji, opisanimi v navedenih prilogah.(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Feedingstuffs,(9) Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Stalnega odbora za krmo –HAS ADOPTED THIS REGULATION:SPREJELA NASLEDNJO UREDBO:Article 1Člen 1The preparations belonging to the group "Micro-organisms" listed in Annex I to the present Regulation are authorised for use as additives in animal nutrition under the conditions laid down in that Annex.Dovoljena je uporaba pripravkov, naštetih v Prilogi I k tej uredbi, ki spadajo v skupino "Mikroorganizmi", kot dodatkov pri prehrani živali v skladu s pogoji, določenimi v navedeni prilogi.Article 2Člen 2The preparations belonging to the group "Enzymes" listed in Annex II to the present Regulation are authorised for use as additives in animal nutrition under the conditions laid down in that Annex.Dovoljena je uporaba pripravkov, naštetih v Prilogi II k tej uredbi, ki spadajo v skupino "Encimi", kot dodatkov pri prehrani živali v skladu s pogoji, določenimi v navedeni prilogi.Article 3Člen 3The additive belonging to the group "Coccidiostats and other medicinal substances" listed in Annex III to the present Regulation is authorised for use as additive in animal nutrition under the conditions laid down in that Annex.Dovoljena je uporaba pripravkov, naštetih v Prilogi III k tej uredbi, ki spadajo v skupino "Kokcidiostatiki in druge zdravilne snovi", kot dodatkov pri prehrani živali v skladu s pogoji, določenimi v navedeni prilogi.Article 4Člen 4This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Communities.Ta uredba začne veljati dan po objavi v Uradnem listu Evropskih skupnosti.It shall apply from 1 March 2001.Uporablja se od 1. marca 2001.This Regulation shall be binding in its entirety and directly applicable in all Member States.Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.Done at Brussels, 1 March 2001.V Bruslju, 1. marca 2001For the CommissionZa KomisijoDavid BYRNEDavid BYRNEMember of the CommissionČlan KomisijeANNEX IPRILOGA ISpecies or |{0>Maximum |{0>Minimum |{0>Maximum |{0>Other provisionsDruge |{0>Period of |

|{0>No (or EC | |{0>Chemical formula, |category of |age Zgornja|contentNaj|contentNaj|določbe ................
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