natgillin/translations-raw huggingface dataset:
In order to comply with the objectives of this Regulation and to take into account technical progress and scientific developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the establishment of specific maximum levels of cross-contamination for active substances in non-target feed and methods of analysis for active substances in feed and of the amendment to the Annexes to this Regulation.
Da bi se upoštevali cilji te uredbe ter tehnični napredek in znanstveni razvoj, bi bilo treba na Komisijo prenesti pooblastilo, da v skladu s členom 290 Pogodbe o delovanju Evropske unije sprejme akte v zvezi z določitvijo posebnih najvišjih mejnih vrednosti navzkrižne kontaminacije neciljne krme z učinkovino in načinov analize učinkovin v krmi ter spremembo prilog k tej uredbi.
Those Annexes concern provisions on feed business operators obligations related to the manufacture, storage, transport and placing on the market of medicated feed and intermediate products, the list of antimicrobial active substances which are most commonly used in medicated feed, the labelling requirements for medicated feed and intermediate products, the permitted tolerances for the compositional labelling of medicated feed or intermediate products and the mandatory information to be included in the veterinary prescription for medicated feed.
Navedene priloge se nanašajo na določbe o obveznostih nosilcev dejavnosti poslovanja s krmo v zvezi s proizvodnjo, skladiščenjem, prevozom in dajanjem v promet medicirane krme in vmesnih proizvodov, seznamu protimikrobnih učinkovin, ki se najpogosteje uporabljajo v medicirani krmi, zahtevah glede označevanja za medicirano krmo in vmesne proizvode, dovoljenih odstopanjih od navedene sestave medicirane krme ali vmesnih proizvodov ter obveznih informacijah, ki jih je treba vključiti v veterinarski recept.
In order to ensure uniform conditions for the implementation of this Regulation regarding the establishment of homogeneity criteria for medicated feed, as well as a model format for the veterinary prescription for medicated feed, implementing powers should be conferred on the Commission.
Da se zagotovijo enotni pogoji za izvajanje te uredbe v zvezi z vzpostavitvijo meril za homogenost medicirane krme ter vzorca obrazca za veterinarski recept za medicirano krmo, bi bilo treba na Komisijo prenesti izvedbena pooblastila.
Member States should lay down rules on penalties applicable to infringement of this Regulation and should take all measures necessary to ensure that they are implemented.
Države članice bi morale določiti pravila o kaznih, ki se uporabljajo za kršitve te uredbe in sprejeti vse potrebne ukrepe, da se zagotovi njihovo izvajanje.
In order to ensure that all manufacturers of medicated feed, including on farm mixers, apply Annex II to Regulation (EC) No 183/2005, that Regulation should be amended accordingly.
Da bi zagotovili, da vsi proizvajalci medicirane krme, vključno z mešalci na kmetijskih gospodarstvih, uporabljajo Prilogo II k Uredbi (ES) št. 183/2005, bi bilo treba navedeno uredbo ustrezno spremeniti.
Since the objectives of this Regulation, namely ensuring a high level of protection of human and animal health, providing adequate information for users and strengthening the effective functioning of the internal market, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Ker ciljev te uredbe, in sicer zagotavljanja visoke ravni varovanja zdravja ljudi in živali, zagotavljanja ustreznih informacij za uporabnike in krepitve učinkovitega delovanja notranjega trga, države članice ne morejo zadovoljivo doseči, temveč se lažje dosežejo na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
This Regulation lays down specific provisions regarding medicated feed and intermediate products, which are additional to Union legislation on feed and apply without prejudice in particular to Regulations (EC) No 1831/2003, (EC) No 183/2005 and (EC) No 767/2009 and Directive 2002/32/EC.
Ta uredba določa posebne določbe o medicirani krmi in vmesnih proizvodih, ki dopolnjujejo zakonodajo Unije o krmi in se uporabljajo brez poseganja zlasti v uredbe (ES) št. 1831/2003, (ES) št. 183/2005 in (ES) št. 767/2009 ter Direktivo 2002/32/ES.
the manufacture, storage and transport of medicated feed and intermediate products;
proizvodnjo, skladiščenje in prevoz medicirane krme in vmesnih proizvodov;
the placing on the market, including import from third countries, and use of medicated feed and intermediate products;
dajanje v promet, vključno z uvozom iz tretjih držav, in uporabo medicirane krme in vmesnih proizvodov;
the export to third countries of medicated feed and intermediate products.
izvoz medicirane krme in vmesnih proizvodov v tretje države.
However, Articles 9, 16, 17 and 18 shall not apply to medicated feed and intermediate products whose label indicates that they are intended for export to third countries.
Vendar se členi 9, 16, 17 in 18 ne uporabljajo za medicirano krmo in vmesne proizvode, na oznaki katerih je navedeno, da so namenjeni izvozu v tretje države.
This Regulation does not apply to veterinary medicinal products as defined in Regulation (EU) 2019/6 except where such products are included in a medicated feed or an intermediate product.
Ta uredba se ne uporablja za zdravila za uporabo v veterinarski medicini, kot so opredeljena v Uredbi (EU) 2019/6, razen kadar so taka zdravila vključena v medicirano krmo ali vmesni proizvod.
the definitions of ‘feed’, ‘feed business’ and ‘placing on the market’ as laid down, respectively, in points 4, 5 and 8 of Article 3 of Regulation (EC) No 178/2002;
opredelitve pojmov „krma“, „dejavnost poslovanja s krmo“ in „dajanje v promet“ iz točk 4, 5 oziroma 8 člena 3 Uredbe (ES) št. 178/2002;
the definitions of ‘feed additives’ and ‘daily ration’ as laid down, respectively, in points (a) and (f) of Article 2(2) of Regulation (EC) No 1831/2003;
opredelitvi pojmov „krmni dodatki“ in „dnevni obrok“ iz točk (a) oziroma (f) člena 2(2) Uredbe (ES) št. 1831/2003;
the definitions of ‘food-producing animal’, ‘non-food-producing animals’, ‘fur animals’, ‘feed materials’, ‘compound feed’, ‘complete feed’, ‘complementary feed’, ‘mineral feed’, ‘minimum storage life’, ‘batch’, ‘labelling’ and ‘label’ as laid down, respectively, in points (c), (d), (e), (g), (h), (i), (j), (k), (q), (r), (s) and (t) of Article 3(2) of Regulation (EC) No 767/2009;
opredelitve pojmov „žival za proizvodnjo živil“, „živali, ki niso namenjene proizvodnji živil“, „kožuharji“, „posamična krmila“, „krmna mešanica“, „popolna krmna mešanica“, „dopolnilna krmna mešanica“, „mineralna krma“, „minimalni rok skladiščenja“, „serija“, „označevanje“ in „oznaka“ iz točk (c), (d), (e), (g), (h), (i), (j), (k), (q), (r), (s) oziroma (t) člena 3(2) Uredbe (ES) št. 767/2009;
the definition of ‘establishment’ as laid down in point (d) of Article 3 of Regulation (EC) No 183/2005;
opredelitev pojma „obrat“ iz točke (d) člena 3 Uredbe (ES) št. 183/2005;
the definitions of ‘official controls’ and ‘competent authorities’ as laid down, respectively, in Article 2(1) and in point 3 of Article 3, of Regulation (EU) 2017/625;
opredelitvi pojmov „uradni nadzor“ in „pristojni organi“ iz člena 2(1) oziroma točke 3 člena 3 Uredbe (EU) 2017/625;
the definitions of ‘veterinary medicinal product’, ‘active substance’, ‘immunological veterinary medicinal product’, ‘antimicrobial’, ‘antiparasitic’, ‘antibiotic’, ‘metaphylaxis’, ‘prophylaxis’, and ‘withdrawal period’, as laid down, respectively, in points 1, 3, 5, 12, 13, 14, 15, 16 and 34 of Article 4 of Regulation (EU) 2019/6, and ‘summary of the product characteristics’ referred to in Article 35 of that Regulation.
opredelitve pojmov „zdravilo za uporabo v veterinarski medicini“, „učinkovina“, „imunološko zdravilo za uporabo v veterinarski medicini“, „protimikrobna snov“, „antiparazitik“, „antibiotik“, „metafilaksa“, „profilaksa“ in „karenca“ iz točk 1, 3, 5, 12, 13, 14, 15, 16 oziroma 34 člena 4 Uredbe (EU) 2019/6 in „povzetek glavnih značilnosti zdravila“ iz člena 35 navedene uredbe.
‘medicated feed’ means a feed, which is ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more veterinary medicinal products or intermediate products with feed materials or compound feed;
„medicirana krma“ pomeni krmo, pripravljeno za neposredno krmljenje živali brez nadaljnje predelave in ki jo sestavlja homogena mešanica enega ali več zdravil za uporabo v veterinarski medicini ali vmesnih proizvodov s posamičnimi krmili ali krmnimi mešanicami;
‘intermediate product’ means a feed, which is not ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more veterinary medicinal products with feed materials or compound feed, exclusively intended to be used for the manufacture of medicated feed;
„vmesni proizvod“ pomeni krmo, ki ni pripravljena za neposredno krmljenje živali brez nadaljnje predelave in ki jo sestavlja homogena mešanica enega ali več zdravil za uporabo v veterinarski medicini s posamičnimi krmili ali krmnimi mešanicami, ki je namenjena izključno za proizvodnjo medicirane krme;
‘non-target feed’ means feed, whether medicated or not, which is not intended to contain a specific active substance;
„neciljna krma“ pomeni krmo, ne glede na to, ali je medicirana ali ne, za katero ni namenjeno, da bi vsebovala določeno učinkovino;
‘cross-contamination’ means contamination of a non-target feed with an active substance originating from the previous use of the facilities or equipment;
„navzkrižna kontaminacija“ pomeni kontaminacijo neciljne krme z učinkovino, do katere pride zaradi prejšnje uporabe objektov ali opreme;
‘feed business operator’ means any natural or legal person responsible for ensuring that the requirements of this Regulation are met within the feed business under that person’s control;
„nosilec dejavnosti poslovanja s krmo“ pomeni katero koli fizično ali pravno osebo, odgovorno za zagotavljanje, da se v okviru dejavnosti poslovanja s krmo pod njenim nadzorom izpolnjujejo zahteve iz te uredbe;
‘mobile mixer’ means a feed business operator with a feed establishment consisting of a specifically equipped vehicle for the manufacture of medicated feed;
„mobilni mešalec“ pomeni nosilca dejavnosti poslovanja s krmo, katerega proizvodni obrat je posebej opremljeno vozilo za proizvodnjo medicirane krme;
‘on-farm mixer’ means a feed business operator manufacturing medicated feed for the exclusive use on its farm;
„mešalec na kmetijskem gospodarstvu“ pomeni nosilca dejavnosti poslovanja s krmo, ki proizvaja medicirano krmo izključno za uporabo na svojem kmetijskem gospodarstvu;
‘veterinary prescription for medicated feed’ means a document issued by a veterinarian for a medicated feed;
„veterinarski recept za medicirano krmo“ pomeni dokument, ki ga izda veterinar za medicirano krmo;
‘advertising’ means the making of a representation in any form in connection with medicated feed and intermediate products in order to promote prescription or use of medicated feed comprising also the supply of samples and sponsorships;
„oglaševanje“ pomeni predstavljanje v kakršni koli obliki v zvezi z medicirano krmo in vmesnimi proizvodi, da bi se spodbujalo predpisovanje ali uporaba medicirane krme, vključno z dobavo vzorcev in sponzorstvi;
‘animal keeper’ means any natural or legal person responsible for animals, whether on a permanent or on a temporary basis.
„imetnik živali“ pomeni vsako fizično ali pravno osebo, ki je trajno ali začasno odgovorna za živali.
MANUFACTURE, STORAGE, TRANSPORT AND PLACING ON THE MARKET
PROIZVODNJA, SKLADIŠČENJE, PREVOZ IN DAJANJE V PROMET
Feed business operators shall manufacture, store, transport and place on the market medicated feed and intermediate products in compliance with Annex I.
Nosilci dejavnosti poslovanja s krmo proizvajajo, skladiščijo, prevažajo in dajejo v promet medicirano krmo in vmesne proizvode v skladu s Prilogo I.
This Article shall not apply to farmers that only buy, store or transport medicated feed for the exclusive use on their farm.
Ta člen se ne uporablja za kmete, ki le kupujejo, skladiščijo ali prevažajo medicirano krmo za izključno uporabo na svojem kmetijskem gospodarstvu.
Notwithstanding the first subparagraph, Section 5 of Annex I shall apply to such farmers.
Ne glede na prvi pododstavek se za te kmete uporablja oddelek 5 Priloge I.
Article 101(2) and Article 105(9) of Regulation (EU) 2019/6 shall apply, mutatis mutandis, to the supply of intermediate products.
Člen 101(2) in člen 105(9) Uredbe (EU) 2019/6 se smiselno uporabljata za dobavo vmesnih proizvodov.
Article 57 and Section 5 of Chapter IV of Regulation (EU) 2019/6 shall apply, mutatis mutandis, to medicated feed and intermediate products.
Člen 57 in oddelek 5 poglavja IV Uredbe (EU) 2019/6 se smiselno uporabljata za medicirano krmo in vmesne proizvode.
Medicated feed and intermediate products shall only be manufactured from veterinary medicinal products, including veterinary medicinal products intended to be used in accordance with Article 112, Article 113 or Article 114 of Regulation (EU) 2019/6, authorised for the purpose of the manufacture of medicated feed in accordance with the conditions laid down in that Regulation.
Medicirana krma in vmesni proizvodi se proizvajajo samo iz zdravil za uporabo v veterinarski medicini, vključno z zdravili za uporabo v veterinarski medicini, namenjenimi za uporabo v skladu s členom 112, členom 113 ali členom 114 Uredbe (EU) 2019/6, dovoljenih za namen proizvajanja medicirane krme v skladu s pogoji iz navedene uredbe.
The feed business operator manufacturing the medicated feed or intermediate product shall ensure that:
Nosilec dejavnosti poslovanja s krmo, ki proizvaja medicirano krmo ali vmesni proizvod, zagotovi, da:
the medicated feed or intermediate product is manufactured in compliance with the relevant conditions laid down in the veterinary prescription for medicated feed or, in the cases referred to in Article 8 of this Regulation, in the summary of the product characteristics, related to the veterinary medicinal products to be incorporated in the feed; those conditions shall include particular provisions regarding known interactions between the veterinary medicinal products and the feed that may impair the safety or the efficacy of the medicated feed or intermediate product;
se medicirana krma ali vmesni proizvod proizvaja v skladu z ustreznimi pogoji, določenimi z veterinarskim receptom za medicirano krmo ali, v primerih iz člena 8 te uredbe, v povzetku glavnih značilnosti zdravila v zvezi z zdravili za uporabo v veterinarski medicini, ki se vključijo v krmo; ti pogoji vključujejo zlasti določbe glede znanega medsebojnega delovanja zdravil za uporabo v veterinarski medicini in krme, ki bi lahko ogrožalo varnost ali učinkovitost medicirane krme ali vmesnega proizvoda;
a feed additive authorised as a coccidiostat or a histomonostat for which a maximum content is set in the respective authorisation act is not incorporated in the medicated feed or intermediate product if it is already used as active substance in the veterinary medicinal product;
se krmni dodatek, dovoljen kot kokcidiostatik ali histomonostatik, za katerega je v zadevnem dovoljenju določena najvišja vsebnost, ne vključi v medicirano krmo ali vmesni proizvod, če se že uporablja kot učinkovina v zdravilu za uporabo v veterinarski medicini;
where the active substance in the veterinary medicinal product is the same as a substance in a feed additive contained in the feed concerned, the total content of that active substance in the medicated feed does not exceed the maximum content set out in the veterinary prescription for the medicated feed or, in the cases referred to in Article 8, in the summary of product characteristics;
skupna vsebnost učinkovine v medicirani krmi ne presega najvišje vsebnosti, navedene na veterinarskem receptu za medicirano krmo ali, v primerih iz člena 8, v povzetku glavnih značilnosti zdravila, kadar je učinkovina zdravila za uporabo v veterinarski medicini enaka učinkovini v krmnem dodatku, ki ga vsebuje zadevna krma;
the veterinary medicinal products incorporated in the feed combine with it to form a stable mixture for the entire storage life of the medicated feed, and respect the expiry date of the veterinary medicinal product, as referred to in point (f) of Article 10(1) of Regulation (EU) 2019/6, provided that the medicated feed or intermediate product is properly stored and handled.
se zdravila za uporabo v veterinarski medicini, ki so vsebovana v krmi, s krmo zmešajo v zmes, ki je stabilna za celotni rok skladiščenja medicirane krme, pri čemer se upošteva datum izteka roka uporabnosti zdravila za uporabo v veterinarski medicini iz točke (f) člena 10(1) Uredbe (EU) 2019/6, če je medicirana krma ali vmesni proizvod ustrezno shranjen in se z njim ustrezno ravna.
Feed business operators supplying medicated feed to the animal keeper shall ensure that the medicated feed complies with the prescription referred to in Article 16.
Nosilci dejavnosti poslovanja s krmo, ki dobavljajo medicirano krmo imetnikom živali, zagotovijo, da je medicirana krma skladna z receptom iz člena 16.
Feed business operators manufacturing medicated feed or intermediate products shall ensure that the veterinary medicinal product is homogeneously dispersed in the medicated feed and in the intermediate product.
Nosilci dejavnosti poslovanja s krmo, ki proizvajajo medicirano krmo ali vmesni proizvod, zagotovijo, da je zdravilo za uporabo v veterinarski medicini homogeno porazdeljeno v medicirani krmi in vmesnem proizvodu.
The Commission may, by means of implementing acts, establish criteria for the homogenous dispersion of the veterinary medicinal product into the medicated feed or into the intermediate product, taking into account the specific properties of the veterinary medicinal products and of the mixing technology.
Komisija lahko z izvedbenimi akti določi merila za homogeno porazdelitev zdravila za uporabo v veterinarski medicini v medicirano krmo ali v vmesni proizvod, ob upoštevanju posebnih lastnosti zdravil za uporabo v veterinarski medicini ter tehnologije mešanja.
Cross-contamination
Navzkrižna kontaminacija
Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate products shall apply measures in accordance with Article 4 to avoid cross-contamination.
Nosilci dejavnosti poslovanja s krmo, ki proizvajajo, skladiščijo, prevažajo ali dajejo v promet medicirano krmo ali vmesne proizvode, uporabljajo ukrepe v skladu s členom 4 z namenom preprečevanja navzkrižne kontaminacije.
The Commission is empowered to adopt delegated acts in accordance with Article 20 in order to supplement this Regulation by establishing specific maximum levels of cross-contamination for active substances in non-target feed, unless such levels are already established in accordance with Directive 2002/32/EC.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 20, da se ta uredba dopolni z določitvijo posebnih najvišjih mejnih vrednosti navzkrižne kontaminacije neciljne krme z učinkovino, razen če so take mejne vrednosti že določene v skladu z Direktivo 2002/32/ES.
Those delegated acts may also set out methods of analysis for active substances in feed.
V teh delegiranih aktih se lahko določijo tudi načini analize učinkovin v krmi.
Regarding maximum levels of cross-contamination, those delegated acts shall be based on a scientific risk assessment carried out by EFSA.
V zvezi z najvišjimi mejnimi vrednostmi navzkrižne kontaminacije ti delegirani akti temeljijo na znanstveni oceni tveganja, ki jo izvede EFSA.
The Commission shall, by 28 January 2023, adopt delegated acts in accordance with Article 20 in order to supplement this Regulation by establishing, as regards the antimicrobial active substances listed in Annex II, specific maximum levels of cross-contamination for active substances in non-target feed and methods of analysis for active substances in feed.
Komisija do 28. januarja 2023 sprejme delegirane akte v skladu s členom 20, da se ta uredba dopolni tako, da se v zvezi s protimikrobnimi učinkovinami iz Priloge II določijo posebne najvišje mejne vrednosti navzkrižne kontaminacije neciljne krme z učinkovino in načine analize učinkovin v krmi.
Regarding maximum levels of cross contamination, those delegated acts shall be based on a scientific risk assessment carried out by EFSA.
V zvezi z najvišjimi mejnimi vrednostmi navzkrižne kontaminacije ti delegirani akti temeljijo na znanstveni oceni tveganja, ki jo izvede EFSA.
For active substances in the veterinary medicinal product which are the same as a substance in a feed additive, the applicable maximum level of cross-contamination in non-target feed shall be the maximum content of feed additive in complete feed established in the relevant Union act.
Najvišja mejna vrednost navzkrižne kontaminacije neciljne krme je za učinkovine v zdravilu za uporabo v veterinarski medicini, ki so enake kot učinkovine v krmnem dodatku, enaka najvišji vsebnosti krmnega dodatka v popolni krmni mešanici, določeni v zadevnem aktu Unije.
Until maximum levels of cross-contamination are established in accordance with paragraphs 2 and 3, Member States may apply national maximum levels of cross-contamination.
Dokler se ne določijo najvišje mejne vrednosti navzkrižne kontaminacije v skladu z odstavkoma 2 in 3, lahko države članice uporabljajo nacionalne najvišje mejne vrednosti navzkrižne kontaminacije.
Anticipated production
Pričakovana proizvodnja
Medicated feed and intermediate products may be manufactured and placed on the market, except as regards the supply to the animal keeper, before the prescription referred to in Article 16 is issued.
Medicirana krma in vmesni proizvodi se lahko proizvajajo in dajejo v promet, z izjemo dobave imetnikom živali, preden se izda recept iz člena 16.
The first paragraph of this Article shall not apply to:
Prvi odstavek tega člena se ne uporablja:
on-farm mixers and mobile mixers;
za mešalce na kmetijskih gospodarstvih in mobilne mešalce;
manufacture of medicated feed or intermediate products incorporating veterinary medicinal products intended to be used in accordance with Article 112 or Article 113 of Regulation (EU) 2019/6.
v primeru proizvodnje medicirane krme ali vmesnih proizvodov, ki vključujejo zdravila za uporabo v veterinarski medicini, namenjenih za uporabo v skladu s členom 112 ali členom 113 Uredbe (EU) 2019/6.
The labelling of medicated feed and intermediate products shall comply with Annex III to this Regulation.
Označevanje medicirane krme in vmesnih proizvodov mora biti skladno s Prilogo III k tej uredbi.
In addition, the specific requirements provided for in Regulation (EC) No 767/2009 for the labelling of feed materials and compound feed shall apply to medicated feed and intermediate products containing, respectively, feed materials or compound feed.
Poleg tega se posebne zahteve iz Uredbe (ES) št. 767/2009 glede označevanja posamičnih krmil in krmnih mešanic uporabljajo za medicirano krmo in vmesne proizvode, ki vsebujejo posamična krmila oziroma krmne mešanice.
Where containers are used instead of packages, they shall be accompanied by a document complying with paragraph 1.
Kadar se namesto embalaže uporabljajo posode, se jim priloži dokument, ki je skladen z odstavkom 1.
Permitted tolerances for discrepancies between the labelled content of an active substance in a medicated feed or an intermediate product and the content analysed in official controls performed in accordance with Regulation (EU) 2017/625 shall be as set out in Annex IV to this Regulation.
Dovoljena odstopanja vsebnosti učinkovine v medicirani krmi ali vmesnih proizvodih, ki je navedena na oznaki, od vsebnosti, analizirane v okviru uradnega nadzora v skladu z Uredbo (EU) 2017/625, so določena v Prilogi IV k tej uredbi.