natgillin/translations-raw huggingface dataset:
When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of measures setting reference points for action and measures reviewing those reference points.
Kadar v nujnih primerih ni mogoče upoštevati običajnih rokov za regulativni postopek s pregledom, bi bilo treba Komisiji omogočiti uporabo nujnega postopka iz člena 5a(6) Sklepa 1999/468/ES za sprejetje ukrepov, ki določajo referenčne vrednosti za ukrepe, in ukrepov za pregled teh referenčnih vrednosti.
Since the objectives of this Regulation, namely the protection of human and animal health and ensuring the availability of appropriate veterinary medicinal products, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of this Regulation, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty.
Ker ciljev te uredbe, in sicer varovanja zdravja ljudi in živali ter zagotavljanja razpoložljivosti ustreznih zdravil za uporabo v veterinarski medicini, države članice ne morejo zadovoljivo doseči in ker te cilje zaradi obsega in učinkov ukrepa lažje doseže Skupnost, lahko Skupnost sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe.
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
V skladu z načelom sorazmernosti iz navedenega člena ta uredba ne prekoračuje okvirov, ki so potrebni za dosego teh ciljev.
In the interests of clarity, it is therefore necessary to replace Regulation (EEC) No 2377/90 with a new regulation.
Zaradi jasnosti bi bilo treba Uredbo (EGS) št. 2377/90 nadomestiti z novo uredbo.
A transitional period should be provided for in order to allow the Commission to prepare and adopt a regulation incorporating the pharmacologically active substances and their classification regarding maximum residue limits as laid down in Annexes I to IV to Regulation (EEC) No 2377/90, as well as certain implementing provisions for that new regulation,
Določiti bi bilo treba prehodno obdobje, ki bi Komisiji omogočilo pripravo in sprejetje uredbe, ki vključuje farmakološko aktivne snovi in njihovo razvrstitev glede na najvišje mejne vrednosti ostankov, kot so navedene v prilogah I do IV Uredbe (EGS) št. 2377/90, pa tudi nekaterih izvedbenih določb za to novo uredbo –
For the purposes of ensuring food safety, this Regulation lays down rules and procedures in order to establish:
Za name zagotavljanja varnosti hrane ta uredba določa pravila in postopke za določitev:
the maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin (maximum residue limit);
najvišje količine ostanka farmakološko aktivne snovi, ki se lahko dovoli v živilih živalskega izvora („najvišja mejna vrednost ostanka“);
the level of a residue of a pharmacologically active substance established for control reasons in the case of certain substances for which a maximum residue limit has not been laid down in accordance with this Regulation (reference point for action).
ravni ostanka farmakološko aktivne snovi, določene zaradi nadzora v primeru nekaterih snovi, za katere najvišja mejna vrednost ostanka ni določena v skladu s to uredbo („referenčna vrednost za ukrepe“).
to active principles of biological origin intended to produce active or passive immunity or to diagnose a state of immunity, used in immunological veterinary medicinal products;
učinkovine biološkega izvora, namenjene ustvarjanju aktivne ali pasivne imunosti ali ugotavljanju stanja imunosti, ki se uporabljajo v imunoloških zdravilih za uporabo v veterinarski medicini;
to substances falling within the scope of Regulation (EEC) No 315/93.
snovi, ki spadajo v področje uporabe Uredbe (EGS) št. 315/93;
This Regulation shall apply without prejudice to Community legislation prohibiting the use in food-producing animals of certain substances having a hormonal or thyrostatic action and of beta-agonists, as provided for by Directive 96/22/EC.
Ta uredba se uporablja brez poseganja v zakonodajo Skupnosti o prepovedi uporabe nekaterih snovi s hormonalnim ali tirostatičnim delovanjem in beta-agonistov pri živalih, namenjenih za proizvodnjo hrane, kakor to določa Direktiva 96/22/ES.
In addition to the definitions laid down in Article 1 of Directive 2001/82/EC, Article 2 of Regulation (EC) No 882/2004 and Articles 2 and 3 of Regulation (EC) No 178/2002, the following definitions shall apply for the purposes of this Regulation:
Poleg opredelitev iz člena 1 Direktive 2001/82/ES, člena 2 Uredbe (ES) št. 882/2004 ter členov 2 in 3 Uredbe (ES) št. 178/2002 se za na namen te uredbe uporabljajo naslednje opredelitve:
‘residues of pharmacologically active substances’ means all pharmacologically active substances, expressed in mg/kg or μg/kg on a fresh weight basis, whether active substances, excipients or degradation products, and their metabolites which remain in food obtained from animals;
„ostanki farmakološko aktivnih snovi“ pomeni vse farmakološko aktivne snovi, izražene v mg/kg ali μg/kg sveže teže, bodisi zdravilne učinkovine, pomožne snovi ali produkte razgradnje in njihove metabolite, ki ostanejo v živilih, pridobljenih iz živali;
‘food-producing animals’ means animals bred, raised, kept, slaughtered or harvested for the purposes of producing food.
„živali, namenjene za proizvodnjo hrane“, pomeni živali, ki se vzrejajo, redijo, gojijo, zakoljejo ali nabirajo za proizvodnjo hrane.
MAXIMUM RESIDUE LIMITS
NAJVIŠJE MEJNE VREDNOSTI OSTANKOV
Risk assessment and risk management
Ocena in obvladovanje tveganja
Pharmacologically active substances intended for use in veterinary medicinal products in the Community
Farmakološko aktivne snovi, namenjene uporabi v zdravilih za uporabo v veterinarski medicini v Skupnosti
Application for an opinion of the Agency
Vloga za pridobitev mnenja agencije
Except in cases where the Codex Alimentarius procedure referred to in Article 14(3) of this Regulation applies, any pharmacologically active substance intended for use in the Community in veterinary medicinal products which are to be administered to food-producing animals shall be subject to an opinion of the European Medicines Agency (the Agency) established by Article 55 of Regulation (EC) No 726/2004 on the maximum residue limit, formulated by the Committee for Medicinal Products for Veterinary Use (the Committee) established by Article 30 of that Regulation.
Razen v primerih, ko se uporablja postopek Codex Alimentarius iz člena 14(3) te uredbe, se glede vsake farmakološko aktivne snovi, namenjene uporabi v zdravilih za uporabo v veterinarski medicini v Skupnosti, ki se dajejo živalim, namenjenim za proizvodnjo hrane, poda mnenje Evropske agencije za zdravila („agencija“), ustanovljene v skladu s členom 55 Uredbe (ES) št. 726/2004, glede najvišjih mejnih vrednosti ostankov, ki ga oblikuje odbor za zdravila za uporabo v veterinarski medicini („odbor“), ustanovljen v skladu s členom 30 navedene uredbe.
To that end, the applicant for a marketing authorisation for a veterinary medicinal product in which such a substance is used, a person intending to apply for such a marketing authorisation or, where appropriate, the holder of such a marketing authorisation, shall submit an application to the Agency.
Zato vložnik zahtevka za dovoljenje za promet z zdravilom za uporabo v veterinarski medicini, v katerem se takšna snov uporablja, oseba, ki namerava zaprositi za takšno dovoljenje za promet, ali po potrebi imetnik takšnega dovoljenja za promet predloži vlogo agenciji.
Opinion of the Agency
Mnenje agencije
The opinion of the Agency shall consist of a scientific risk assessment and risk management recommendations.
Mnenje agencije vsebuje znanstveno oceno tveganja in priporočila za obvladovanje tveganja.
The scientific risk assessment and the risk management recommendations shall aim to ensure a high level of human health protection, whilst also ensuring that human health, animal health and animal welfare are not negatively affected by the lack of availability of appropriate veterinary medicinal products.
Namen znanstvene ocene tveganja in priporočil za obvladovanje tveganja je zagotoviti visoko raven varovanja zdravja ljudi ter hkrati preprečiti, da bi premajhna razpoložljivost ustreznih zdravil za uporabo v veterinarski medicini negativno vplivala na zdravje ljudi in živali ter dobro počutje živali.
The opinion shall take account of any relevant scientific findings of the European Food Safety Authority (EFSA) established by Article 22 of Regulation (EC) No 178/2002.
To mnenje upošteva vsa ustrezna znanstvena dognanja Evropske agencije za varnost hrane („EFSA“), ustanovljene s členom 22 Uredbe (ES) št. 178/2002.
With a view to ensuring the availability of authorised veterinary medicinal products for conditions affecting food-producing animals, the Agency, while ensuring a high level of protection of human health, shall, when carrying out scientific risk assessments and when drawing up risk management recommendations, consider using maximum residue limits established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or maximum residue limits established for a pharmacologically active substance in one or more species for other species.
Za zagotovitev razpoložljivosti dovoljenih zdravil za uporabo v veterinarski medicini za bolezni, ki prizadenejo živali, namenjene za proizvodnjo hrane, agencija pri pripravi znanstvenih ocen tveganj in oblikovanju priporočil za obvladovanje tveganj, in ob hkratnem zagotavljanju visoke ravni varovanja zdravja ljudi, pretehta o tem, da se najvišja mejna vrednost ostanka, ki je za neko farmakološko aktivno snov v posameznem živilu že ugotovljena, uporabi tudi za drugo živilo, pridobljeno iz iste živalske vrste, oziroma da se najvišja mejna vrednost ostanka, ki je za neko farmakološko aktivno snov že ugotovljena za eno ali več živalskih vrst, uporabi tudi za druge živalske vrste.
Scientific risk assessment
Znanstvena ocena tveganja
The scientific risk assessment shall consider the metabolism and depletion of pharmacologically active substances in relevant animal species, the type of residues and the amount thereof, that may be ingested by human beings over a lifetime without an appreciable health risk expressed in terms of acceptable daily intake (ADI).
Pri znanstveni oceni tveganja se upoštevajo presnova in izločanje farmakološko aktivnih snovi pri zadevnih živalskih vrstah, vrsta ostankov in njihova količina, ki jo lahko ljudje zaužijejo v življenjskem obdobju brez znatnega tveganja za zdravje in je izražena s sprejemljivim dnevnim vnosom.
Alternative approaches to ADI may be used, if they have been laid down by the Commission as provided for in Article 13(2).
Uporabijo se lahko alternativni pristopi v zvezi s sprejemljivim dnevnim vnosom, če jih je Komisija določila v skladu s členom 13(2).
The scientific risk assessment shall concern the following:
Znanstvena ocena tveganja zadeva naslednje:
the type and amount of residue considered not to present a safety concern for human health;
vrsto in količino ostankov, za kateri velja, da ne pomenita nevarnosti za zdravje ljudi;
the risk of toxicological, pharmacological or microbiological effects in human beings;
tveganje toksikoloških, farmakoloških ali mikrobioloških učinkov pri ljudeh;
residues that occur in food of plant origin or that come from the environment.
ostanke, ki se pojavijo v živilih rastlinskega izvora ali ki izvirajo iz okolja.
If the metabolism and depletion of the substance cannot be assessed, the scientific risk assessment may take into account monitoring data or exposure data.
Če presnove in izločanja snovi ni mogoče oceniti, se lahko pri znanstveni oceni tveganja upoštevajo podatki o spremljanju ali izpostavljenosti.
Risk management recommendations
Priporočila za obvladovanje tveganja
The risk management recommendations shall be based on the scientific risk assessment performed in accordance with Article 6 and shall consist of an assessment of the following:
Priporočila za obvladovanje tveganja temeljijo na znanstveni oceni tveganja, izvedeni v skladu s členom 6, in vsebujejo oceno:
the availability of alternative substances for the treatment of the relevant species or the necessity of the substance evaluated in order to avoid unnecessary suffering for animals or to ensure the safety of those treating them;
razpoložljivosti alternativnih snovi za zdravljenje zadevnih živalskih vrst ali potrebe po ocenjeni snovi, da se prepreči nepotrebno trpljenje živali ali zagotovi varnost tistih, ki jih zdravijo;
other legitimate factors, such as the technological aspects of food and feed production, the feasibility of controls, conditions of use and application of the substances in veterinary medicinal products, good practice in the use of veterinary medicinal and biocidal products and the likelihood of misuse or illegal use;
drugih upravičenih dejavnikov, kot so tehnološki vidiki proizvodnje živil in krme, izvedljivost nadzora, pogoji uporabe in aplikacije snovi v zdravilih za uporabo v veterinarski medicini, dobre veterinarske prakse pri uporabi veterinarskih zdravil in biocidnih pripravkov ter verjetnost zlorabe ali nedovoljene oziroma prepovedane uporabe;
whether or not a maximum residue limit or a provisional maximum residue limit should be established for a pharmacologically active substance in veterinary medicinal products, the level of that maximum residue limit and, where appropriate, any conditions or restrictions for the use of the substance concerned;
ali je treba določiti najvišjo ali začasno mejno vrednost ostanka za farmakološko aktivno snov v zdravilih za uporabo v veterinarski medicini, raven te najvišje mejne vrednosti ostanka in po potrebi katere koli pogoje ali omejitve za uporabo zadevne snovi;
whether the data provided are not sufficient to allow a safe limit to be identified, or whether a final conclusion concerning human health with regard to residues of a substance cannot be established given the lack of scientific information.
kadar zagotovljeni podatki ne zadostujejo za določitev varne vrednosti ali kadar ni mogoče sprejeti končne odločitve v zvezi z zdravjem ljudi glede ostankov snovi zaradi pomanjkanja znanstvenih podatkov.
In either case, no maximum residue limit may be recommended.
V obeh primerih ni mogoče priporočiti najvišje mejne vrednosti ostankov.
Applications and procedures
Vloge in postopki
The application referred to in Article 3 shall comply with the format and content laid down by the Commission as provided for in Article 13(1) and shall be accompanied by the fee payable to the Agency.
Vloga iz člena 3 je skladna z obliko in vsebino, ki ju določi Komisija v skladu s členom 13(1), in ji je priložena pristojbina, ki jo je treba plačati agenciji.
The Agency shall ensure that the opinion of the Committee is given within 210 days of receipt of a valid application in accordance with Article 3 and paragraph 1 of this Article.
Agencija zagotovi, da odbor poda mnenje v 210 dneh od prejema veljavne vloge v skladu s členom 3 in odstavkom 1 tega člena.
This time limit shall be suspended where the Agency requests the submission of supplementary information on the given substance within a specific time period, and shall remain suspended until such time as the requested supplementary information has been provided.
Kadar agencija zahteva, da se v določenem obdobju predložijo dodatne informacije o zadevni snovi, se ta rok prekliče in se odloži do predložitve zahtevanih dodatnih informacij.
The Agency shall forward the opinion referred to in Article 4 to the applicant.
Agencija mnenje iz člena 4 pošlje predlagatelju vloge.
Within 15 days of receipt of the opinion, the applicant may provide written notice to the Agency that he wishes to request a re-examination of the opinion.
Predlagatelj vloge lahko agenciji v 15 dneh od prejema mnenja pošlje pisno obvestilo, da želi ponovno preučitev mnenja.
In that case the applicant shall submit the detailed grounds for his request to the Agency within 60 days of receipt of the opinion.
V tem primeru predlagatelj vloge agenciji v 60 dneh od prejema mnenja predloži natančno utemeljitev svoje zahteve.
Within 60 days of receipt of the applicant’s grounds for a re-examination request, the Committee shall consider whether its opinion should be revised and adopt the final opinion.
Odbor v 60 dneh od prejema utemeljitve zahteve za ponovno preučitev predlagatelja preuči, ali bi bilo treba mnenje spremeniti in nato sprejme končno odločitev.
The reasons for the conclusion reached on the request shall be annexed to the final opinion.
Razlogi za odločitev, sprejeto na zahtevo, so priloženi končnemu mnenju.
Within 15 days of the adoption of the final opinion, the Agency shall forward it to the Commission and the applicant, stating the grounds for its conclusions.
Agencija v 15 dneh od sprejetja končnega mnenja to skupaj z obrazložitvijo pošlje Komisiji in predlagatelju vloge.
Other pharmacologically active substances for which an opinion of the Agency may be requested
Druge farmakološko aktivne snovi, glede katerih je mogoče zaprositi za mnenje agencije
Opinion of the Agency requested by the Commission or a Member State
Mnenje agencije na zahtevo Komisije ali države članice
The Commission or a Member State may submit to the Agency a request for an opinion on maximum residue limits in either of the following circumstances:
Komisija ali država članica lahko agenciji predloži zahtevke za mnenje o najvišjih mejnih vrednostih ostankov v katerem koli od naslednjih primerov:
where the substance in question is authorised for use in a veterinary medicinal product in a third country and no application for the establishment of a maximum residue limit for that substance in respect of the foodstuff or species concerned has been submitted pursuant to Article 3;
zadevna snov je odobrena za uporabo v zdravilu za uporabo v veterinarski medicini v tretji državi, v zvezi s to snovjo pa ni bila predložena nobena vloga v skladu s členom 3 za določitev najvišje mejne vrednosti ostankov v zadevnem živilu ali vrsti;
where the substance in question is included in a medicinal product intended to be used pursuant to Article 11 of Directive 2001/82/EC and no application for the establishment of a maximum residue limit for that substance in respect of the foodstuff or species concerned has been submitted pursuant to Article 3 of this Regulation.
zadevna snov je vključena v zdravilo, namenjeno uporabi v skladu s členom 11 Direktive 2001/82/ES, v zvezi s to snovjo pa ni bila predložena nobena vloga v skladu s členom 3 te uredbe za določitev najvišje mejne vrednosti ostankov v zadevnem živilu ali vrsti.
In the circumstances of point (b) of the first subparagraph, where minor species or minor uses are concerned, the request may be submitted to the Agency by an interested party or organisation.
V okoliščinah iz točke (b) prvega pododstavka, ko gre za manjše vrste ali uporabe v manjši meri, lahko zahtevek agenciji predloži zainteresirana stran ali organizacija.
Articles 4 to 7 shall apply.
Uporabljajo se členi 4 do 7.
A request for an opinion referred to in the first subparagraph of this paragraph shall comply with the format and content requirements laid down by the Commission pursuant to Article 13(1).
Zahtevki za mnenje iz prvega pododstavka tega odstavka izpolnjujejo zahteve glede oblike in vsebine, ki jih določi Komisija v skladu s členom 13(1).
The Agency shall ensure that the opinion of the Committee is given within 210 days of receipt of the request by the Commission, a Member State or an interested party or organisation.
Agencija zagotovi, da odbor predloži mnenje v 210 dneh od prejema zahtevka Komisije, države članice ali zainteresirane strani ali organizacije.
This time limit shall be suspended if the Agency requests the submission of supplementary information on the given substance within a specific time period and until such time as the requested supplementary information has been provided.
Če agencija zahteva, da se v določenem obdobju predložijo dodatne informacije o zadevni snovi, se ta časovni rok prekliče do predložitve zahtevanih dodatnih informacij.
Within 15 days of the adoption of the final opinion, the Agency shall forward it to the Commission and, as applicable, to the Member State or the interested party or organisation which made the request, stating the grounds for its conclusions.
Agencija v 15 dneh od sprejetja končnega mnenja to pošlje Komisiji in po potrebi državi članici ali zainteresirani strani ali organizaciji, ki je vložila zahtevek, ob tem pa navede razloge za svoje sklepe.
Pharmacologically active substances contained in biocidal products used in animal husbandry
Farmakološko aktivne snovi v biocidnih izdelkih, ki se uporabljajo v živinoreji
For the purposes of Article 10(2)(ii) of Directive 98/8/EC, for pharmacologically active substances intended to be used in a biocidal product used in animal husbandry, the maximum residue limit shall be established:
Za namene iz člena 10(2)(ii) Direktive 98/8/ES je treba najvišjo mejno vrednost ostanka za farmakološko aktivne snovi, namenjene uporabi v biocidnem pripravku, ki se uporablja v živinoreji, določiti:
following the procedure referred to in Article 9 of this Regulation for:
v skladu s postopkom iz člena 9 te uredbe za:
active substances/product type combinations included in the 10-year programme of work referred to in Article 16(2) of Directive 98/8/EC;
kombinacije aktivnih snovi/vrst pripravkov, vključene v 10-letni program dela iz člena 16(2) Direktive 98/8/ES;
active substances/product type combinations to be included in Annexes I, IA or IB to Directive 98/8/EC for which a dossier has been accepted by the competent authority as referred to in Article 11(1)(b) of that Directive before 6 July 2009;
kombinacije aktivnih snovi/vrst pripravkov, ki bodo vključene v priloge I, IA ali IB Direktive 98/8/ES, za katere je pristojni organ sprejel dokumentacijo, kot je navedeno v členu 11(1)(b) navedene direktive, pred 6. julija 2009;
following the procedure referred to in Article 8 of this Regulation and on the basis of an application submitted in accordance with Article 3 of this Regulation for all other active substances/product type combinations to be included in Annexes I, IA or IB to Directive 98/8/EC for which the establishment of a maximum residue limit is deemed necessary by the Member States or the Commission.
v skladu s postopkom iz člena 8 te uredbe in na podlagi vloge, predložene v skladu s členom 3 te uredbe, za vse druge kombinacije aktivnih snovi/vrst pripravkov, ki se vključijo v priloge I, IA ali IB Direktive 98/8/ES, za katere države članice ali Komisija menijo, da jim je treba določiti najvišjo mejno vrednost ostankov.
The Commission shall classify the pharmacologically active substances referred to in paragraph 1 in accordance with Article 14.
Komisija razvrsti farmakološko aktivne snovi iz odstavka 1 v skladu s členom 14.
For the purposes of classification, a regulation as referred to in Article 17(1) shall be adopted by the Commission.
Za namene razvrstitve Komisija sprejme uredbo iz člena 17(1).
However, any specific provisions relating to the conditions of use of the substances classified in accordance with the first subparagraph of this paragraph shall be laid down pursuant to Article 10(2) of Directive 98/8/EC.
V skladu s členom 10(2) Direktive 98/8/ES pa se določijo morebitne posebne določbe v zvezi s pogoji uporabe snovi, ki so razvrščene v skladu s prvim pododstavkom tega odstavka.
The costs of evaluations carried out by the Agency following a request made in accordance with paragraph 1(a) of this Article shall be covered by the budget of the Agency as referred to in Article 67 of Regulation (EC) No 726/2004.
Stroški ocen, ki jih opravi agencija na podlagi zahtevka v skladu z odstavkom 1(a) tega člena, se krijejo iz proračuna agencije, kot je navedeno v členu 67 Uredbe (ES) št. 726/2004.