natgillin/translations-raw huggingface dataset:
However, this shall not apply to the evaluation costs of a rapporteur designated, in accordance with Article 62(1) of that Regulation, for the establishment of a maximum residue limit where that rapporteur has been appointed by a Member State that has already received a fee for that evaluation on the basis of Article 25 of Directive 98/8/EC.
To pa ne velja za stroške ocen poročevalca, ki je bil določen v skladu s členom 62(1) navedene uredbe, za določitev najvišje mejne vrednosti ostankov, če je bil ta poročevalec določen s strani države članice, ki je že prejela pristojbino za to oceno na podlagi člena 25 Direktive 98/8/ES.
The amount of the fees for evaluations carried out by the Agency and the rapporteur following an application made in accordance with paragraph 1(b) of this Article shall be established in accordance with Article 70 of Regulation (EC) No 726/2004.
Znesek pristojbin za ocene, ki jih opravijo agencija in poročevalec na podlagi vloge, vložene v skladu z odstavkom 1(b) tega člena, se določi v skladu s členom 70 Uredbe št. 726/2004.
Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products [17] shall apply.
Uporablja se Uredba Sveta (ES) št. 297/95 z dne 10. februarja 1995 o pristojbinah, ki se plačujejo Evropski agenciji za vrednotenje zdravil [17].
Review of an opinion
Pregled mnenja
Where the Commission, the applicant under Article 3 or a Member State, as a result of new information, considers that a review of an opinion is necessary in order to protect human or animal health, it may request the Agency to issue a new opinion on the substances in question.
Kadar Komisija, vložnik po členu 3 ali država članica na podlagi novih informacij meni, da je potrebna preučitev mnenja za varovanje zdravja ljudi in živali, lahko od agencije zahteva izdajo novega mnenja o zadevni snovi.
Where a maximum residue limit has been established in accordance with this Regulation for specific foodstuffs or species, Articles 3 and 9 shall apply for the establishment of a maximum residue limit for that substance for other foodstuffs or species.
Kadar je za posebna živila ali vrste v skladu s to uredbo določena najvišja mejna vrednost ostankov, se za določitev najvišje mejne vrednosti ostankov za te snovi v drugih živilih ali vrstah uporabljata člena 3 in 9.
The request referred to in the first subparagraph shall be accompanied by information explaining the issue to be addressed.
Zahtevku iz prvega pododstavka mora biti priloženo pojasnilo vprašanja, ki ga je treba obravnavati.
Article 8(2) to (4) or Article 9(2) and (3), as appropriate, shall apply to the new opinion.
Za novo mnenje se, kakor je primerno, uporablja člen 8(2) do (4) oziroma člen 9(2) in (3).
Publication of opinions
Objava mnenj
The Agency shall publish the opinions referred to in Articles 4, 9 and 11 after deleting any information of a commercially confidential nature.
Agencija objavi mnenja iz členov 4, 9 in 11, potem ko izbriše vse poslovne ali zaupne informacije.
In accordance with the regulatory procedure referred to in Article 25(2), the Commission shall, in consultation with the Agency, adopt measures regarding the form and content of the applications and requests referred to in Articles 3 and 9.
Komisija v skladu z regulativnim postopkom iz člena 25(2) in v posvetovanju z agencijo sprejme ukrepe glede oblike in vsebine vlog in zahtevkov iz členov 3 in 9.
The Commission shall, in consultation with the Agency, Member States and interested parties, adopt measures regarding:
Komisija v posvetovanju z agencijo, državami članicami in zainteresiranimi stranmi sprejme ukrepe v zvezi z:
the methodological principles for the risk assessment and risk management recommendations referred to in Articles 6 and 7, including technical requirements in accordance with internationally agreed standards;
metodološkimi načeli ocene tveganja in priporočili za obvladovanje tveganja iz členov 6 in 7, vključno s tehničnimi zahtevami v skladu z mednarodno dogovorjenimi standardi;
rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or a maximum residue limit established for a pharmacologically active substance in one or more species for other species, as referred to in Article 5.
pravili o uporabi najvišjih mejnih vrednosti ostankov, ugotovljenih za neko farmakološko aktivno snov v posameznem živilu, za drugo živilo iste vrste ali najvišje mejne vrednosti ostankov, ugotovljenih za neko farmakološko aktivno snov za eno ali več živalskih vrst za druge vrste, kakor je določeno v členu 5.
Those rules shall specify how and under what circumstances scientific data on residues in a particular foodstuff or in a species or more species may be used for setting a maximum residue limit in other foodstuffs, or other species.
Ta pravila določajo, kako in v kakšnih okoliščinah se lahko uporabijo znanstveni podatki o ostankih v posameznem živilu ali vrsti ali več vrstah za določanje najvišjih mejnih vrednosti ostankov v drugih živilih ali drugih vrstah.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3).
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te uredbe z njeno dopolnitvijo, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 25(3).
Classification of pharmacologically active substances
Razvrstitev farmakološko aktivnih snovi
The Commission shall classify the pharmacologically active substances subject to an opinion of the Agency on the maximum residue limit in accordance with Article 4, 9 or 11, as appropriate.
Komisija razvrsti farmakološko aktivne snovi, za katere je potrebno mnenje agencije o najvišjih mejnih vrednostih ostankov v skladu s členi 4, 9 ali 11, kakor je primerno.
The classification shall include a list of pharmacologically active substances and the therapeutic classes to which they belong.
Razvrstitev vključuje seznam farmakološko aktivnih snovi in terapevtske razrede, v katere spadajo.
The classification shall also establish, in relation to each such substance, and, where appropriate, specific foodstuffs or species, one of the following:
Razvrstitev določi za vsako takšno snov in po potrebi za vsako živilo ali vrsto tudi enega od naslednjih elementov:
the absence of the need to establish a maximum residue limit;
odsotnosti potrebe po določitvi najvišje mejne vrednosti ostankov;
a prohibition on the administration of a substance.
prepovedi dajanja snovi.
A maximum residue limit shall be laid down where it appears necessary for the protection of human health:
Najvišja mejna vrednost ostankov se določi, kadar se to zdi potrebno za varovanje zdravja ljudi:
pursuant to an opinion of the Agency in accordance with Article 4, 9 or 11, as appropriate; or
na podlagi mnenja agencije v skladu s členi 4, 9 ali 11, kakor je primerno; ali
pursuant to a decision of the Codex Alimentarius Commission, without objection from the Community Delegation, in favour of a maximum residue limit for a pharmacologically active substance intended for use in a veterinary medicinal product, provided that the scientific data taken into consideration have been made available to the Community Delegation prior to the decision of the Codex Alimentarius Commission.
na podlagi odločitve Komisije Codex Alimentarius, ki ji delegacija Skupnosti ni nasprotovala, za najvišjo mejno vrednost ostankov za farmakološko aktivno snov, namenjeno uporabi v zdravilih za uporabo v veterinarski medicini, pod pogojem, da je imela delegacija Skupnosti pred glasovanjem v Komisiji Codex Alimentarius na voljo znanstvene podatke, na podlagi katerih je bila sprejeta odločitev.
In this case, an additional assessment by the Agency shall not be required.
V tem primeru se dodatna ocena agencije ne zahteva.
A provisional maximum residue limit may be established in cases where scientific data are incomplete, provided that there are no grounds for supposing that residues of that substance at the level proposed constitute a hazard to human health.
Začasna najvišja mejna vrednost ostanka se lahko določi, kadar so znanstveni podatki nepopolni, pod pogojem, da ni razloga za domnevo, da predlagane količine ostankov zadevne snovi ogrožajo zdravje ljudi.
The provisional maximum residue limit shall apply for a defined period of time, which shall not exceed five years.
Začasna najvišja mejna vrednost ostankov se uporablja za natančno določeno obdobje, ki ne presega petih let.
That period may be extended once for a period not exceeding two years where it is demonstrated that such an extension would allow completion of scientific studies in progress.
To obdobje se lahko podaljša enkrat za največ dve leti, kadar je dokazano, da bi takšno podaljšanje omogočilo dokončanje znanstvenih študij, ki so v teku.
No maximum residue limit shall be established where, pursuant to an opinion in accordance with Article 4, 9 or 11, as appropriate, it is not necessary for the protection of human health.
Najvišja mejna vrednost ostanka se ne določi, kadar ta na podlagi mnenja v skladu s členi 4, 9 ali 11, kakor je primerno, ni potrebna za varovanje zdravja ljudi.
The administration of a substance to food-producing animals shall be prohibited, pursuant to an opinion in accordance with Article 4, 9 or 11, as appropriate, in either of the following circumstances:
Dajanje snovi živalim, namenjenim za proizvodnjo hrane, je prepovedano na podlagi mnenja v skladu s členi 4, 9 ali 11, kakor je primerno, v katerem koli od naslednjih primerov:
where any presence of a pharmacologically active substance or residues thereof in foods of animal origin may constitute a hazard to human health;
kadar kakršna koli prisotnost farmakološko aktivne snovi ali njenih ostankov v živilih živalskega izvora lahko predstavlja nevarnost za zdravje ljudi;
where no final conclusion concerning the effect on human health of residues of a substance can be drawn.
kadar ni mogoče sprejeti nobene dokončne ugotovitve glede ostankov snovi za zdravje ljudi.
Where it appears necessary for the protection of human health, the classification shall include conditions and restrictions for the use or application of a pharmacologically active substance used in veterinary medicinal products which is subject to a maximum residue limit, or for which no maximum residue limit has been set.
Kadar se zdi to potrebno za varovanje zdravja ljudi, razvrstitev vključuje pogoje in omejitve uporabe ali aplikacije farmakološko aktivne snovi, ki se uporablja v zdravilih za uporabo v veterinarski medicini in za katero velja najvišja mejna vrednost ostankov ali za katero ni bila določena nobena najvišja mejna vrednost ostankov.
Accelerated procedure for an opinion of the Agency
Pospešeni postopek za mnenje agencije
In specific cases where a veterinary medicinal product or a biocidal product needs to be authorised as a matter of urgency for reasons relating to the protection of public health or of animal health or welfare, the Commission, any person who has submitted an application for an opinion pursuant to Article 3 or a Member State may ask the Agency to carry out an accelerated procedure for the assessment of the maximum residue limit of a pharmacologically active substance contained in those products.
V posebnih primerih, ko je treba zdravilo za uporabo v veterinarski medicini ali biocidni pripravek nujno odobriti zaradi varovanja zdravja ljudi oziroma zdravja ali dobrega počutja živali, lahko Komisija, vsaka oseba, ki je predložila vlogo za mnenje v skladu s členom 3, ali država članica agencijo zaprosi za izvedbo pospešenega postopka za oceno najvišje mejne vrednosti ostanka farmakološko aktivne snovi, vsebovane v teh pripravkih.
The format and content of the application referred to in paragraph 1 of this Article shall be laid down by the Commission pursuant to Article 13(1).
Obliko in vsebino vloge iz odstavka 1 tega člena določi Komisija v skladu z določbami iz člena 13(1).
By way of derogation from the time limits laid down in Article 8(2) and Article 9(2), the Agency shall ensure that the opinion of the Committee is given within 120 days of receipt of the application.
Z odstopanjem od rokov iz členov 8(2) in 9(2) agencija zagotovi, da odbor mnenje da v 120 dneh od prejema vloge.
Administration of substances to food-producing animals
Dajanje snovi živalim, namenjenim za proizvodnjo hrane
Only pharmacologically active substances which are classified in accordance with Article 14(2)(a), (b) or (c) may be administered to food-producing animals within the Community, provided that such administration is in accordance with Directive 2001/82/EC.
Živalim, namenjenim za proizvodnjo hrane v Skupnosti, se lahko dajejo samo farmakološko aktivne snovi, razvrščene v skladu s členom 14(2)(a), (b) ali (c), če je taka uporaba v skladu z določbami Direktive 2001/82/ES.
Paragraph 1 shall not apply in the case of clinical trials which are accepted by the competent authorities following notification or authorisation in accordance with the legislation in force and which do not cause foodstuffs obtained from livestock participating in such trials to contain residues which constitute a hazard to human health.
Odstavek 1 se ne uporablja v primerih kliničnih testov, ki jih odobrijo pristojni organi po priglasitvi ali odobritvi v skladu z veljavno zakonodajo, če ti ne povzročajo, da bi živila, pridobljena iz živali, ki so vključene v takšne teste, vsebovala ostanke, ki predstavljajo tveganje za zdravje ljudi.
For the purposes of the classification provided for in Article 14, the Commission shall prepare a draft regulation within 30 days of receipt of an opinion of the Agency as referred to in Article 4, 9 or 11, as appropriate.
Komisija za namen razvrstitve iz člena 14 pripravi osnutek uredbe v tridesetih dneh od prejema mnenja agencije iz členov 4, 9 ali 11, kakor je primerno.
The Commission shall also prepare a draft regulation within 30 days of receipt of the decision of the Codex Alimentarius Commission, without objection from the Community Delegation, in favour of the establishment of a maximum residue limit as referred to in Article 14(3).
Komisija pripravi tudi osnutek uredbe v tridesetih dneh od prejema odločitve Komisije Codex Alimentarius za določitev najvišje mejne vrednosti ostankov iz člena 14(3), ki ji delegacija Skupnosti ne nasprotuje.
Where the opinion of the Agency is required and the draft regulation is not in accordance with this opinion, the Commission shall provide a detailed explanation of the reasons for the divergence.
Kadar se zahteva mnenje agencije, osnutek uredbe pa ni v skladu s tem mnenjem, Komisija zagotovi podrobno utemeljitev razlogov za odstopanja.
The regulation referred to in paragraph 1 of this Article shall be adopted by the Commission in accordance with, and within 30 days of the end of, the regulatory procedure referred to in Article 25(2).
Komisija sprejme uredbo iz odstavka 1 tega člena v skladu z regulativnim postopkom iz člena 25(2) in najkasneje v 30 dneh po njegovem zaključku.
In the case of an accelerated procedure as referred to in Article 15, the Commission shall adopt the regulation referred to in paragraph 1 of this Article in accordance with, and within 15 days of the end of, the regulatory procedure referred to in Article 25(2).
Komisija v primeru pospešenega postopka iz člena 15 sprejme uredbo iz odstavka 1 tega člena v skladu z regulativnim postopkom iz člena 25(2) in najkasneje v 15 dneh po njegovem zaključku.
REFERENCE POINTS FOR ACTION
REFERENČNE VREDNOSTI ZA UKREPE
Establishment and review
Določitev in pregled
When it is deemed necessary in order to ensure the functioning of controls of food of animal origin imported or placed on the market in accordance with Regulation (EC) No 882/2004, the Commission may establish reference points for action for residues from pharmacologically active substances which are not subject to a classification in accordance with Article 14(2)(a), (b) or (c).
Kadar se zdi potrebno zagotoviti delovanje nadzora živil živalskega izvora, uvoženih ali danih v promet v skladu z Uredbo (ES) št. 882/2004, lahko Komisija vzpostavi referenčne vrednosti za ukrepe za ostanke farmakološko aktivnih snovi, ki niso predmet razvrstitve v skladu s členom 14(2)(a), (b) ali (c).
The reference points for action shall be reviewed regularly in the light of new scientific data relating to food safety, the outcome of the investigations and analytical tests referred to in Article 24 and technological progress.
Referenčne vrednosti za ukrepe se ob upoštevanju novih znanstvenih podatkov o varnosti hrane, zaključkih preiskav in analiz iz člena 24 in tehnološkega napredka redno pregledujejo.
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 26(3).
Navedeni ukrepi, namenjeni spreminjanju nebistvenih določb te uredbe, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 26(3).
On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 26(4).
Komisija lahko v njunih primerih uporabi nujni postopek iz člena 26(4).
Methods for establishing reference points for action
Metode za določitev referenčnih vrednosti za ukrepe
The reference points for action to be established pursuant to Article 18 shall be based on the content of an analyte in a sample, which can be detected and confirmed by official control laboratories designated in accordance with Regulation (EC) No 882/2004 with an analytical method validated in accordance with Community requirements.
Referenčne vrednosti za ukrepe, ki se določijo v skladu s členom 18, temeljijo na vsebini analita v vzorcu, ki ga lahko odkrijejo in potrdijo uradni laboratoriji za nadzor, imenovani v skladu z Uredbo (ES) št. 882/2004, z uporabo analizne metode, potrjene v skladu z zahtevami Skupnosti.
The reference point for action should take into account the lowest residue concentration which can be quantified with an analytical method validated in accordance with Community requirements.
Referenčna vrednost za ukrepe bi morala upoštevati najnižjo količino ostanka, ki jo je mogoče določiti z analizno metodo, potrjeno v skladu z zahtevami Skupnosti.
The Commission shall be advised on the performance of analytical methods by the relevant Community reference laboratory.
Pri tem Komisiji o izvajanju analiznih metod svetuje ustrezni referenčni laboratorij Skupnosti.
Without prejudice to the second subparagraph of Article 29(1) of Regulation (EC) No 178/2002, the Commission shall, where appropriate, submit a request to EFSA for a risk assessment as to whether the reference points for action are adequate to protect human health.
Brez poseganja v drugi pododstavek člena 29(1) Uredbe št. 178/2002 Komisija EFSA po potrebi pošlje zahtevek za oceno tveganja, da bi se ugotovilo, ali so referenčne vrednosti za ukrepe primerne za varovanje zdravja ljudi.
In those cases, EFSA shall ensure that the opinion is given to the Commission within 210 days of receipt of the request.
EFSA v teh primerih zagotovi, da Komisija dobi mnenje v 210 dneh od prejema zahtevka.
The principles of risk assessment shall be applied in order to guarantee a high level of protection of health.
Uporabljajo se načela za oceno tveganja, da se zagotovi visoka raven varovanja zdravja.
The risk assessment shall be based on methodological principles as well as scientific methods to be adopted by the Commission in consultation with EFSA.
Ocena tveganja mora temeljiti na metodoloških načelih in znanstvenih metodah, ki jih mora Komisija sprejeti v posvetovanju z EFSA.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 26(3).
Navedeni ukrepi, namenjeni spreminjanju nebistvenih določb te uredbe z njenim dopolnjevanjem, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 26(3).
Community contribution to the support measures for reference points for action
Prispevek Skupnosti podpornim ukrepom za referenčne vrednosti za ukrepe
If the application of this Title requires the Community to finance measures in support of the establishment and functioning of reference points for action, Article 66(1)(c) of Regulation (EC) No 882/2004 shall apply.
Če uporaba tega naslova zahteva od Skupnosti financiranje ukrepov za podporo vzpostavitvi in delovanju referenčnih vrednosti za ukrepe, se uporablja člen 66(1)(c) Uredbe (ES) št. 882/2004.
The Agency shall consult Community reference laboratories for laboratory analysis of residues designated by the Commission in accordance with Regulation (EC) No 882/2004 on appropriate analytical methods for detecting residues of pharmacologically active substances for which maximum residue limits have been determined in accordance with Article 14 of this Regulation.
Agencija se o ustreznih analiznih metodah za odkrivanje ostankov farmakološko aktivnih snovi, za katere so bile določene najvišje mejne vrednosti ostankov v skladu s členom 14 te uredbe, posvetuje z referenčnimi laboratoriji Skupnosti za laboratorijsko analizo ostankov, ki jih je določila Komisija v skladu z Uredbo (ES) št. 882/2004.
For the purposes of harmonised controls, the Agency shall provide information regarding those methods to the Community reference laboratories and national reference laboratories designated in accordance with Regulation (EC) No 882/2004.
Da bi se dosegel usklajen nadzor, zagotovi agencija informacije glede navedenih metod referenčnim laboratorijem Skupnosti in nacionalnim referenčnim laboratorijem, določenim v skladu z Uredbo (ES) št. 882/2004.
Circulation of foodstuffs
Kroženje živil
Member States may not prohibit or impede the import or the placing on the market of food of animal origin on grounds related to maximum residue limits or reference points for action where this Regulation and its implementing measures have been complied with.
Države članice ne smejo prepovedati ali ovirati uvoza in dajanja živil živalskega izvora v promet iz razlogov, povezanih z najvišjimi mejnimi vrednostmi ostankov ali referenčnimi vrednostmi za ukrepe, kadar so izpolnjene zahteve te uredbe in njenih izvedbenih ukrepov.
Food of animal origin containing residues of a pharmacologically active substance:
Za živila živalskega izvora, ki vsebujejo ostanke farmakološko aktivne snovi in ki
classified in accordance with Article 14(2)(a), (b) or (c) at a level exceeding the maximum residue limit established pursuant to this Regulation; or
so razvrščena v skladu s členom 14(2)(a), (b) ali (c), na raven, ki je višja od najvišje mejne vrednosti ostankov, določene v skladu s to uredbo; ali ki
not classified in accordance with Article 14(2)(a), (b) or (c), except where a reference point for action has been set for that substance pursuant to this Regulation and the level of residues does not equal or exceed that reference point for action;
niso razvrščena v skladu s členom 14(2)(a), (b) ali (c), razen v primerih, kjer je za to snov določena referenčna vrednost za ukrepe v skladu s to uredbo in raven ostankov ni enaka tej referenčni vrednosti za ukrepe ali od nje ni višja,
shall be considered not to comply with Community legislation.
se šteje, da niso skladna z zakonodajo Skupnosti.
Detailed rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated under Article 11 of Directive 2001/82/EC shall be adopted by the Commission in accordance with the regulatory procedure referred to in Article 26(2) of this Regulation.
Komisija v skladu z regulativnim postopkom iz člena 26(2) te uredbe sprejme podrobna pravila o najvišji mejni vrednosti ostankov, ki jo je treba upoštevati za nadzor živil živalskega izvora, za katera se je uporabil člen 11 Direktive 2001/82/ES.
Action in case of confirmed presence of a prohibited or non-authorised substance
Ukrepi v primeru potrjene prisotnost prepovedane ali nedovoljene snovi