natgillin/translations-raw huggingface dataset:
Without prejudice to the general obligations laid down in Article 12 of Regulation (EC) No 178/2002 concerning exports of feed to third countries, this Regulation should apply to medicated feed and intermediate products which are manufactured, stored, transported or placed on the market within the Union with the intention to be exported.
Brez poseganja v splošne obveznosti iz člena 12 Uredbe (ES) št. 178/2002 glede izvoza krme v tretje države bi se za medicirano krmo in vmesne proizvode, ki se proizvedejo, skladiščijo, prevažajo ali dajejo v promet v Uniji z namenom, da se izvozijo, morala uporabljati ta uredba.
However, the specific requirements concerning labelling, prescription and use of medicated feed and intermediate products, laid down in this Regulation, should not apply to products intended to be exported.
Vendar se za proizvode, namenjene izvozu, ne bi smele uporabljati posebne zahteve glede označevanja, izdajanja receptov ter uporabe medicirane krme in vmesnih proizvodov iz te uredbe.
While veterinary medicinal products and the supply thereof are covered by Regulation (EU) 2019/6, intermediate products are not and should therefore be specifically covered by this Regulation in a corresponding way.
Zdravila za uporabo v veterinarski medicini in njihova dobava so zajeta v Uredbi (EU) 2019/6, vmesni proizvodi pa ne, zato bi jih bilo treba ustrezno posebej zajeti v tej uredbi.
Medicated feed should be manufactured only with veterinary medicinal products authorised for the purpose of the manufacture of medicated feed and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product.
Medicirano krmo bi bilo treba proizvajati samo z zdravili za uporabo v veterinarski medicini, ki so dovoljena za proizvodnjo medicirane krme, za varnost in učinkovitost zdravila pa bi bilo treba zagotoviti tudi združljivost vseh uporabljenih sestavin.
Additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be provided for to ensure safe and efficient treatment of the animals.
Da bi zagotovili varno in učinkovito zdravljenje živali, bi bilo treba določiti dodatne posebne zahteve ali navodila za vključitev zdravil za uporabo v veterinarski medicini v krmo.
Homogeneous dispersion of the veterinary medicinal product into the feed is also crucial for the manufacture of a safe and efficient medicated feed.
Za proizvodnjo varne in učinkovite medicirane krme je ključnega pomena tudi homogena porazdelitev zdravila za uporabo v veterinarski medicini v krmi.
Therefore, the possibility to establish criteria, such as target values, for the homogeneity of the medicated feed should be provided for.
Zato bi bilo treba zagotoviti možnost, da se za homogenost medicirane krme vzpostavijo merila, kot so ciljne vrednosti.
Feed business operators may manufacture within one establishment a broad range of feeds for different target animals and containing different types of compounds such as feed additives or veterinary medicinal products.
Nosilci dejavnosti poslovanja s krmo lahko v enem obratu proizvajajo številne vrste krme za različne ciljne živali, ki vsebujejo različne vrste sestavin, kot so krmni dodatki ali zdravila za uporabo v veterinarski medicini.
The manufacture of different types of feed after each other in the same production line may result in the presence of traces of an active substance in the line, which ends up in the beginning of the production of another feed.
Pri proizvodnji različnih vrst krme ene za drugo na isti proizvodni liniji lahko pride do tega, da se sledi učinkovine, ki ostanejo od proizvodnje ene vrste, pojavijo na začetku proizvodnje druge.
That transfer of traces of an active substance from one production batch to another is called ‘cross-contamination’.
Tak prenos sledi učinkovine iz ene proizvodne serije v drugo se imenuje „navzkrižna kontaminacija“.
Cross-contamination may occur during manufacture, processing, storage or transport of feed where the same production and processing equipment, including for mobile mixing, storage facilities or means of transport are used for feed with different components.
Do navzkrižne kontaminacije lahko pride med proizvodnjo, predelavo, skladiščenjem ali prevozom krme, kadar se za krmo z različnimi sestavinami uporabljajo ista oprema za proizvodnjo in predelavo, vključno z mobilnim mešanjem, isti prostori za skladiščenje ali ista prevozna sredstva.
For the purposes of this Regulation, the concept of cross-contamination is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed.
Za namene te uredbe se pojem „navzkrižna kontaminacija“ uporablja za prenos sledov učinkovine iz medicirane krme v neciljno krmo.
Contamination of non-target feed with active substances contained in medicated feed should be avoided or kept as low as possible.
Kontaminaciji neciljne krme z učinkovinami, ki jih vsebuje medicirana krma, bi se bilo treba izogniti ali pa ga čim bolj omejiti.
In order to protect animal health, human health and the environment, maximum levels of cross-contamination for active substances in non-target feed should be established, based on a scientific risk assessment performed by the European Food Safety Authority (EFSA) and in cooperation with the European Medicines Agency, as well as taking into account the application of good manufacturing practice and the ‘as low as reasonably achievable’ (‘ALARA’) principle.
Da bi zaščitili zdravje živali in ljudi ter okolje, bi bilo treba določiti najvišje mejne vrednosti navzkrižne kontaminacije neciljne krme z učinkovino, in sicer na podlagi znanstvene ocene tveganja Evropske agencije za varnost hrane (EFSA) in v sodelovanju z Evropsko agencijo za zdravila ter ob upoštevanju uporabe dobre proizvodne prakse in načela „tako nizko, kakor je to mogoče doseči z uporabo razumnih ukrepov“.
Until the completion of that scientific risk assessment, national maximum levels of cross-contamination for active substances in non-target feed, regardless of its origin, should apply, taking into account the unavoidable cross-contamination and the risk caused by the active substances concerned.
Do zaključka te znanstvene ocene tveganja bi se morale ob upoštevanju neizogibne navzkrižne kontaminacije in tveganja, ki ga povzročajo zadevne učinkovine, uporabljati nacionalne najvišje mejne vrednosti navzkrižne kontaminacije neciljne krme z učinkovino, ne glede na izvor.
Labelling of medicated feed should comply with the general principles laid down in Regulation (EC) No 767/2009 and should be subject to specific labelling requirements in order to provide the user with the information necessary to correctly administer the medicated feed.
Označevanje medicirane krme bi moralo biti v skladu s splošnimi načeli iz Uredbe (ES) št. 767/2009 in zanj bi se morale uporabljati posebne zahteve glede označevanja, da bi uporabnikom zagotovili potrebne informacije za pravilen vnos medicirane krme.
Similarly, limits for the deviations of the labelled content of medicated feed from the actual content should be established.
Podobno bi bilo treba vzpostaviti omejitve za odstopanje vsebine medicirane krme, navedene na oznaki, od dejanske vsebine.
Medicated feed and intermediate products should be marketed in sealed packages or containers for safety reasons and to protect users’ interests.
Medicirano krmo in vmesne proizvode bi bilo treba iz varnostnih razlogov in za zaščito interesov uporabnikov tržiti v zapečatenih posodah.
This should not apply to mobile mixers that supply medicated feed directly to the animal keeper.
To ne bi smelo veljati za mobilne mešalce, ki medicirano krmo dobavljajo neposredno imetnikom živali.
The advertising of medicated feed could affect public and animal health and distort competition.
Oglaševanje medicirane krme bi lahko vplivalo na javno zdravje in zdravje živali ter izkrivljalo konkurenco.
Therefore, advertising of medicated feed should satisfy certain criteria.
Zato bi moralo oglaševanje medicirane krme izpolnjevati določena merila.
Veterinarians can properly evaluate the information available in advertising because of their knowledge and experience in animal health.
Veterinarji lahko zaradi svojega znanja in izkušenj na področju zdravja živali ustrezno ocenijo informacije, ki so na voljo pri oglaševanju.
The advertising of medicated feed to persons who cannot properly appreciate the risk associated with their use may lead to medicine misuse or overconsumption which is liable to harm public or animal health, or the environment.
Oglaševanje medicirane krme za osebe, ki ne morejo ustrezno razumeti tveganja, povezanega z njeno uporabo, lahko privede do zlorabe ali prekomerne uporabe zdravil, kar lahko ogrozi javno zdravje ali zdravje živali ali okolje.
For intra-Union trade and import of medicated feed, it should be ensured that the veterinary medicinal products contained therein are allowed for use in the destination Member State in accordance with Regulation (EU) 2019/6.
Za trgovanje z medicirano krmo znotraj Unije in njen uvoz bi bilo treba zagotoviti, da so zdravila za uporabo v veterinarski medicini, ki jih vsebuje krma, dovoljena za uporabo v namembni državi članici v skladu z Uredbo (EU) 2019/6.
It is important to take into consideration the international dimension of the development of antimicrobial resistance.
Pomembno je, da se upošteva mednarodna razsežnost razvoja odpornosti mikrobov proti protimikrobnim snovem (v nadaljnjem besedilu: mikrobna odpornost).
Antimicrobial resistant organisms can spread to humans and animals in the Union and third countries through consumption of products of animal origin, from direct contact with animals or humans or by other means.
Organizmi, odporni proti protimikrobnim snovem se lahko razširijo na ljudi in živali v Uniji in tretjih državah z uživanjem proizvodov živalskega izvora, neposrednim stikom z živaljo ali ljudmi ali na druge načine.
This has been recognised in Article 118 of Regulation 2019/6 which provides that operators in third countries are to respect certain conditions relating to antimicrobial resistance for animals and products of animal origin exported from such third countries to the Union.
To dejstvo je priznano v členu 118 Uredbe 2019/6, ki določa, da morajo izvajalci dejavnosti v tretjih državah spoštovati določene pogoje v zvezi z mikrobno odpornostjo za živali in proizvode živalskega izvora, uvožene iz teh tretjih držav v Unijo.
This is to be taken into consideration also in respect of the use of antimicrobial medicinal products concerned if they are administered via medicated feed.
To je treba upoštevati tudi v zvezi z uporabo zadevnih protimikrobnih zdravil, če se vnesejo prek medicirane krme.
Furthermore, in the context of international cooperation and in line with the activities and policies of international organisations such as the World Health Organization (WHO) Global Action Plan and the Strategy on Antimicrobial Resistance and the Prudent use of Antimicrobials of the World Organisation for Animal Health, steps restricting the use of medicated feed containing antimicrobials in order to prevent a disease should be considered worldwide for animals and products of animal origin exported from third countries to the Union.
Poleg tega bi bilo treba v okviru mednarodnega sodelovanja ter v skladu z dejavnostmi in politikami mednarodnih organizacij, kot sta Svetovni akcijski načrt Svetovne zdravstvene organizacije in Strategija o mikrobni odpornosti ter preudarni rabi protimikrobnih snovi Svetovne organizacije za zdravje živali, preučiti uvedbo ukrepov za omejitev uporabe medicirane krme, ki vsebuje protimikrobne snovi, zaradi preprečevanja bolezni po vsem svetu za živali in proizvode živalskega izvora, izvožene iz tretjih držav v Unijo.
Feed business operators manufacturing – whether they operate in a feed mill, with a specially equipped vehicle or on-farm – storing, transporting or placing on the market medicated feed and intermediate products, should be approved by the competent authority, in accordance with the approval system laid down in Regulation (EC) No 183/2005, in order to ensure both feed safety and product traceability.
Nosilce dejavnosti poslovanja s krmo, ki proizvajajo, bodisi v obratu za proizvodnjo krme, v posebej opremljenem vozilu ali na kmetijskem gospodarstvu, skladiščijo, prevažajo ali dajejo v promet medicirano krmo in vmesne proizvode, bi moral odobriti pristojni organ v skladu s sistemom odobritve iz Uredbe (ES) št. 183/2005, da se zagotovita varnost krme in sledljivost proizvodov.
Feed business operators dealing with some lower risk activities, such as certain types of transport, storage and retail, should be exempted from the approval obligation, however this should not exempt them from the registration obligation under the registration system laid down in Regulation (EC) No 183/2005.
Nosilci dejavnosti poslovanja s krmo, ki se ukvarjajo z nekaterimi dejavnostmi z manjšim tveganjem, kot so nekatere vrste prevoza, skladiščenja in prodaje na drobno, bi morali biti izvzeti iz obveznosti odobritve, vendar zaradi tega ne bi smeli biti izvzeti iz obveznosti registracije v skladu s sistemom registracije iz Uredbe (ES) št. 183/2005.
To ensure appropriate use and full traceability for medicated feed, retailers of medicated feed for pets and keepers of fur animals feeding animals with medicated feed, which are not subject to the approval obligations, should provide information to competent authorities.
Da bi se zagotovila ustrezna uporaba in popolna sledljivost medicirane krme, bi morali trgovci na drobno z medicirano krmo za hišne živali in imetnike kožuharjev, ki krmijo živali z medicirano krmo, za katere ne veljajo obveznosti odobritve, pristojnim organom zagotoviti informacije.
Provision should be made for a transition procedure concerning establishments already approved under Directive 90/167/EEC.
Določiti bi bilo treba postopek prehoda v zvezi z že odobrenimi obrati v skladu z Direktivo 90/167/EGS.
Care should be taken to ensure that the medicated-feed-handling requirements laid down in this Regulation and in the delegated and implementing acts adopted pursuant to this Regulation concerning feed business operators, in particular on-farm mixers, are feasible and practical.
Poskrbeti bi bilo treba, da bodo zahteve za ravnanje z medicirano krmo iz te uredbe ter delegiranih in izvedbenih aktov, sprejetih na podlagi te uredbe, v zvezi z nosilci dejavnosti poslovanja s krmo, zlasti mešalci na kmetijskem gospodarstvu, izvedljive in praktične.
In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription for medicated feed which has been issued by a veterinarian after examination or any other proper assessment of the health status of the animals to be treated.
Da bi zagotovili varno uporabo medicirane krme, bi morala biti za njeno dobavo in uporabo potrebna predložitev veljavnega veterinarskega recepta za medicirano krmo, ki ga izda veterinar po pregledu ali drugi ustrezni oceni zdravstvenega stanja živali, ki jih je treba zdraviti.
However, the possibility to manufacture medicated feed before a veterinary prescription for medicated feed is presented to the manufacturer should not be excluded.
Vendar se možnost proizvodnje medicirane krme, preden se proizvajalcu predloži veterinarski recept za medicirano krmo, ne bi smela izključiti.
Where medicated feed has been prescribed in a Member State by a veterinarian, it should as a general rule be possible for that veterinary prescription for medicated feed to be recognised and for the medicated feed to be dispensed in another Member State.
Kadar v eni državi članici veterinar predpiše medicirano krmo, bi moralo praviloma biti mogoče, da je navedeni veterinarski recept za medicirano krmo priznan v drugi državi članici in da se tam izda medicirana krma.
By way of derogation, a Member State could allow a prescription for medicated feed to be issued by a professional person qualified to do so, other than a veterinarian, in accordance with applicable national law at the time of entry into force of this Regulation.
Z odstopanjem bi lahko država članica določila, da recept za medicirano krmo izda pooblaščena strokovna oseba, ki ni veterinar, v skladu z nacionalnim pravom, ki se uporablja ob začetku veljavnosti te uredbe.
Such a prescription for medicated feed issued by such a professional person, other than a veterinarian, should be valid only in that Member State and should exclude the prescription of medicated feed containing antimicrobial veterinary medicinal products and of any other veterinary medicinal products where a diagnosis by a veterinarian is necessary.
Tak recept za medicirano krmo, ki ga izda taka strokovna oseba, ki ni veterinar, bi moral veljati le v tej državi članici in izključiti predpisovanje medicirane krme, ki vsebuje protimikrobna zdravila za uporabo v veterinarski medicini, in vseh drugih zdravil za uporabo v veterinarski medicini, ko je potrebna veterinarska diagnoza.
In order to ensure prudent use – which means appropriate use of medicines in accordance with the veterinary prescription for medicated feed and the summary of product characteristics – of medicated feed for food-producing animals and fur animals and therefore provide the basis for the assurance of a high level of protection of animal health and public health, specific conditions concerning the use and the validity of the veterinary prescription for medicated feed, compliance with the withdrawal period and record-keeping by the animal keeper, where appropriate, should be provided for.
Da bi zagotovili previdno uporabo, kar pomeni ustrezno uporabo zdravil v skladu z veterinarskim receptom za medicirano krmo in povzetkom glavnih značilnosti proizvoda, medicirane krme pri živalih za proizvodnjo živil in kožuharjih in s tem tudi podlago za zagotavljanje visoke ravni varovanja zdravja živali in javnega zdravja, bi bilo treba po potrebi določiti posebne pogoje za uporabo in veljavnost veterinarskih receptov, skladnost s karenco in vodenje evidenc s strani imetnikov živali.
Taking into account the serious public health risk posed by antimicrobial resistance, it is appropriate to limit the use of medicated feed containing antimicrobials for animals.
Ob upoštevanju resnega tveganja za javno zdravje, povezanega z razvojem mikrobne odpornosti, je primerno omejiti uporabo medicirane krme, ki vsebuje protimikrobne snovi, pri živalih.
Prophylaxis or use of medicated feed to enhance the performance of animals should not be allowed, except, in certain cases, as regards medicated feed containing antiparasitics and immunological veterinary medicinal products.
Profilaksa ali uporaba medicirane krme za povečanje proizvodnosti živali ne bi smeli biti dovoljeni, razen v določenih primerih glede medicirane krme, ki vsebuje antiparazitike in imunološka zdravila za uporabo v veterinarski medicini.
The use of medicated feed containing antimicrobials for metaphylaxis should only be allowed when the risk of spread of an infection or of an infectious disease is high, in accordance with Regulation 2019/6.
Uporaba medicirane krme, ki vsebuje protimikrobne snovi za metafilakso, bi morala biti dovoljena le, kadar je tveganje za širjenje okužbe ali nalezljivo bolezen visoko, v skladu z Uredbo 2019/6.
The use of medicated feed containing some antiparasitics should be based on the knowledge of the parasite infestation status in the animal or group of animals.
Uporaba medicirane krme, ki vsebuje nekatere antiparazitike, bi morala temeljiti na poznavanju statusa okužbe s paraziti na živali ali skupini živali.
Despite the measures that farmers take to ensure good hygiene and biosecurity, animals may suffer from diseases which need to be prevented by medicated feed for reasons of both animal health and welfare.
Kljub ukrepom, ki jih kmetje izvajajo za zagotovitev dobre higiene in biološke varnosti, lahko živali trpijo zaradi bolezni, ki jih je treba zaradi zdravja živali in za njihovo dobro počutje preprečiti z medicirano krmo.
Animal diseases which are transmissible to humans may also have a significant impact on public health.
Živalske bolezni, ki se prenašajo na ljudi, lahko tudi znatno vplivajo na javno zdravje.
Therefore the use of medicated feed containing immunological veterinary medicinal products or some antiparasitics should be allowed in the absence of a diagnosed disease.
Zato bi bilo treba dovoliti uporabo medicirane krme, ki vsebuje imunološka zdravila za uporabo v veterinarski medicini ali nekatere antiparazitike, tudi če bolezen ni diagnosticirana.
In accordance with Regulation (EC) No 1831/2003, the ban on the use of antibiotics as growth promoting agents as from 1 January 2006 should be strictly adhered to and properly enforced.
V skladu z Uredbo (ES) št. 1831/2003 bi bilo treba dosledno spoštovati in ustrezno izvrševati prepoved uporabe antibiotikov kot sredstva za pospeševanje rasti, ki velja od 1. januarja 2006.
The ‘One Health’ concept, endorsed by the WHO and the World Organization for Animal Health (OIE), recognises that human health, animal health and ecosystems are interconnected and it is therefore essential for both animal and human health to ensure prudent use of antimicrobial medicinal products in food-producing animals.
V okviru koncepta „eno zdravje“, ki ga podpirata Svetovna zdravstvena organizacija in Svetovna organizacija za zdravje živali, se priznava, da so zdravje ljudi, zdravje živali in ekosistemi med seboj povezani in je zato tako za zdravje živali kot za zdravje ljudi bistveno, da se zagotovi previdna uporaba protimikrobnih zdravil pri živalih za proizvodnjo živil.
On 17 June 2016, the Council adopted conclusions on the next steps under a One Health approach to combat antimicrobial resistance.
Svet je 17. junija 2016 sprejel sklepe o nadaljnjih ukrepih v okviru pristopa „eno zdravje“ za boj proti mikrobni odpornosti.
On 13 September 2018, the European Parliament adopted a resolution on a European One Health Action Plan against Antimicrobial Resistance.
Evropski parlament je 13. septembra 2018 sprejel resolucijo o evropskem akcijskem načrtu „eno zdravje“ proti mikrobni odpornosti.
A system for the collection or discard of unused or expired intermediate products and medicated feed should be in place, including through existing systems and when managed by feed business operators, in order to control any risk that such products might raise with regard to the protection of animal or human health or the environment.
Treba bi bilo imeti sistem za zbiranje ali zavrženje neuporabljenih vmesnih proizvodov in medicirane krme ali vmesnih proizvodov in medicirane krme, ki jim je potekel rok uporabnosti, tudi v okviru obstoječih sistemov in v primeru upravljanja s strani nosilcev dejavnosti poslovanja s krmo, da bi nadzirali tveganje, ki bi ga taki proizvodi lahko povzročili v zvezi z varovanjem zdravja živali ali ljudi ali varovanjem okolja.
The decision as to who is responsible for such collection or discard system should remain a national competence.
Odločitev o tem, kdo je odgovoren za tak sistem zbiranja ali zavrženja, bi morala ostati v nacionalni pristojnosti.
Member States should take measures to ensure that appropriate consultations with relevant stakeholders are carried out to ensure the fitness for purpose of such systems.
Države članice bi morale sprejeti ukrepe za zagotovitev, da se izvedejo ustrezna posvetovanja z zadevnimi deležniki za zagotovitev prave namembnosti teh sistemov.