natgillin/translations-raw huggingface dataset:
Razlogi za sprejet sklep o zahtevi so priloženi končnemu mnenju iz odstavka 4.
The reasons for the conclusion reached on the request shall be annexed to the final opinion referred to in paragraph 4.
Agencija v 15 dneh od sprejetja končnega mnenja to posreduje Komisiji in vložniku, ob tem pa navede razloge za svoje sklepe.
Within 15 days of the adoption of the final opinion, the Agency shall forward it both to the Commission and to the applicant, stating the grounds for its conclusions.
Farmakološko aktivne snovi, ki niso namenjene za uporabo v zdravilih za uporabo v veterinarski medicini
Pharmacologically active substances not intended for use in veterinary medicinal products
Mnenje Agencije na zahtevo Komisije ali držav članic
Agency's opinion requested by the Commission or the Member States
za farmakološko aktivne snovi v enem od naslednjih primerov:
for pharmacologically active substances in any of the following circumstances:
zadevna snov je odobrena za uporabo v zdravilu za uporabo v veterinarski medicini v tretji državi in v zvezi s to snovjo ni bila predložena nobena vloga v skladu s členom 3, ali
the substance in question is authorised for use in a veterinary medicinal product in a third country and no application in respect of that substance has been submitted pursuant to Article 3, or
zadevna snov je vključena v zdravilo, namenjeno za uporabo v skladu s členom 11 Direktive 2001/82/ES in v zvezi s to snovjo ni bila predložena nobena vloga v skladu s členom 3, ali
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 in respect of that substance has been submitted pursuant to Article 3 of this Regulation, or
zadevna snov je vključena v biocidni proizvod, ki se uporablja pri vzreji živali, mejna vrednost ostankov pa mora biti določena v skladu s členom 10(2)(ii)(b) Direktive 98/8/ES Evropskega parlamenta in Sveta
the substance in question is included in a biocidal product used in animal-rearing and a maximum residue limit must be established pursuant to Article 10(2)(ii)(b) of Directive 98/8/EC of the European Parliament and of the Council
zadevna snov se lahko uporablja za učinkovito zdravljenje živali, kadar gre za manj pomembne vrste ali uporabe v manjši meri, za katere še ni specifičnih zdravil.
the substance in question can be used to treat animals effectively, in the case of minor species or minor uses, where no specific medicines yet exist.
Zahtevki za mnenje iz odstavka 1 tega člena izpolnjujejo zahteve glede oblike in vsebine, ki jih določi Komisija v skladu s členom 12(1).
The applications for an opinion which are referred to in paragraph 1 shall comply with the format and content requirements laid down by the Commission pursuant to Article 12(1).
Agencija zagotovi mnenje Odbora v 210 dneh po prejemu zahtevka Komisije.
The Agency shall ensure that the opinion of the Committee is given within 210 days following the receipt of the request by the Commission.
Ta časovni rok se prekliče, kadar Agencija zahteva predložitev dodatnih informacij o zadevni snovi v določenem obdobju, preklic pa traja do predložitve zahtevanih dodatnih informacij.
This time limit shall be suspended when the Agency requests submission of supplementary information on the given substance within a specific time period, and until such time as the supplementary information requested has been provided.
Agencija v 15 dneh od sprejetja končnega mnenja to posreduje Komisiji in, glede na okoliščine, državi članici ali stranki, ki je vložila zahtevek, ob tem pa navede razloge za svoj sklep.
Within 15 days of the adoption of the final opinion, the Agency shall forward it to the Commission and, as the case may be, to the Member State or party which made the request, stating the grounds for its conclusions.
Skupne določbe
Common provisions
Proučitev mnenja
Review of an opinion
Kadar Komisija,
Where the Commission,
ali člen 9(5) in (6) se uporablja
Article 9(5) and (6)
za novo mnenje.
respectively shall apply to the new opinion.
Objava mnenj
Publication of opinions
Agencija objavi mnenja iz členov 4, 9 in 10, potem ko izbriše vse poslovne ali zaupne podatke.
The Agency shall publish the opinions referred to in Articles 4, 9 and 10, after deleting any information of a commercially confidential nature.
Izvedbeni ukrepi
Implementing Measures
Komisija ▌v posvetovanju z Agencijo sprejme
▌ The Commission shall, in consultation with the Agency, adopt
obliko, v kateri je treba predložiti vloge iz člena 3 in zahtevke iz člena 9, ter vsebino teh vlog;
the form in which applications referred to in Article 3 and requests referred to in Article 9 are to be presented, and the content of these applications;
metodološka načela ocene tveganja in priporočil za obvladovanje tveganja iz členov 6 in 7, vključno s tehničnimi zahtevami v skladu z mednarodno dogovorjenimi standardi.
the methodological principles of the risk assessment and risk management recommendations referred to in Articles 6 and 7, including technical requirements in accordance with internationally agreed standards.
Pravila iz točke (a) se sprejmejo v skladu z regulativnim postopkom iz člena 23(2) in v primeru točke (b) v skladu z regulativnim postopkom s pregledom iz člena 23(3).
The rules referred to in point (a) shall be adopted in accordance with the regulatory procedure referred to in Article 23(2) and, in the case of point (b), in accordance with the regulatory procedure with scrutiny referred to in Article 23(3).
Komisija v posvetovanju z Agencijo
The Commission shall, in consultation with the Agency
in zainteresiranimi stranmi
and interested parties
sprejme pravila o uporabi mejnih vrednosti ostankov posameznega živila za drugo živilo enake vrste ali ene ali več vrst za druge vrste, kakor je navedeno v členu 5.
, adopt rules on the use of a maximum residue level of a particular foodstuff for another foodstuff of the same species, or of one or more species for other species as referred to in Article 5.
Navedeni ukrepi za spremembo nebistvenih določb te uredbe z njeno dopolnitvijo se sprejmejo v skladu z regulativnim postopkom s pregledom iz
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
člena 23(3)
Article 23(3)
POGLAVJE II RAZVRSTITEV
CHAPTER II CLASSIFICATION
Razvrstitev vključuje seznam farmakološko aktivnih snovi in terapevtske razrede, v katere spadajo.
The classification shall include a list of pharmacologically active substances and the therapeutic classes to which they belong.
Razvrstitev glede na vsako tako snov vsebuje tudi določitev enega od naslednjih elementov:
The classification shall also entail the establishment, in relation to each such substance, of one of the following:
mejno vrednost ostankov;
a maximum residue limit;
začasno mejno vrednot ostankov;
a provisional maximum residue limit;
odsotnost mejne vrednosti ostankov;
the absence of a maximum residue limit;
ali njenih ostankov v proizvodu živalskega izvora
or residues thereof in a product of animal origin
Mejno vrednost ostankov je treba določiti, kadar se zdi to potrebno za varovanje zdravja ljudi:
A maximum residue limit shall be laid down where it appears necessary for the protection of human health:
na podlagi mnenja Agencije v skladu s členi 4, 9 ali 10
pursuant to an opinion of the Agency in accordance with Articles 4, 9 or 10
pri komisiji Codex Alimentarius
Delegation at the Codex Alimentarius
, pod pogojem, da je imela delegacija Skupnosti v komisiji Codex Alimentarius omenjene znanstvene podatke na voljo pred glasovanjem v komisiji Codex Alimentarius
, provided that the scientific data taken into consideration have been made available to the Community representative in Codex Alimentarius prior to the vote in the Codex Alimentarius Commission
primeru se dodatna ocena Agencije ne zahteva.
case an additional assessment by the Agency is not required.
Začasna mejna vrednost ostankov se lahko določi za farmakološko aktivno snov, kadar so znanstveni podatki nepopolni, pod pogojem, da ni razloga za domnevo, da ostanki zadevne snovi na predlagani ravni
A provisional maximum residue limit may be established for a pharmacologically active substance in cases where scientific data are incomplete, provided that there are no grounds for supposing that residues of the substance concerned at the level proposed present a
zdravje ljudi.
for human health.
Začasne mejne vrednosti ostankov se uporabljajo za obdobje, ki ne presega petih let.
The provisional maximum residue limit shall apply for a defined period of time, which shall not exceed five years.
Mejna vrednost ostankov se ne določi, kadar ta na podlagi mnenja v skladu s členi 4, 9 ali 10 ni potrebna za varovanje zdravja ljudi.
No maximum residue limit shall be established where, pursuant to an opinion in accordance with Articles 4, 9 or 10, it is not necessary for the protection of human health.
kadar kakršna koli
where any
farmakološko aktivne snovi
of a pharmacologically active substance
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, za katero velja mejna vrednost ostankov, ali za katero ni bila določena nobena najvišja mejna vrednost ostankov.
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.
Ne glede na določbe členov 8(2) in 9(5) Agencija zagotovi, da lahko odbor poda svoje mnenje v 150 dneh po prejemu vloge.
Notwithstanding the provisions of Articles 8(2) and 9(2), the Agency shall ensure that the Committee is able to issue its opinion within 150 days following receipt of the application.
Običajni postopek
Normal procedure
Codex Alimentarius za določitev
Delegation at the Codex Alimentarius
najvišjih dovoljenih vrednosti ostankov, kot določa člen 13(3).
in favour of the establishment of a maximum residue limit ▌ as referred to in Article 13(3).
Kadar osnutek uredbe ni v skladu z mnenjem Agencije, Komisija zagotovi podrobno pojasnilo razlogov za razlike.
Where the draft Regulation is not in accordance with the opinion of the Agency, the Commission shall provide a detailed explanation of the reasons for the differences.
Komisija v primeru pospešenega postopka iz člena 14 sprejme uredbo iz odstavka 1 tega člena v 15 dneh po koncu regulativnega postopka iz člena 20(2).
In the case of the accelerated procedure referred to in Article 14, the Commission shall adopt the Regulation referred to in paragraph 1 of this Article within 15 days of the end of the regulatory procedure referred to in Article 23(2).
Analizne metode
Analytical methods
Agencija se posvetuje z referenčnimi laboratoriji Skupnosti za laboratorijsko analizo ostankov, ki jih je imenovala Komisija v skladu z Uredbo (ES) št. 882/2004, o ustreznih analiznih metodah
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
za usklajeno vzorčenje
for harmonised sampling
za odkrivanje ostankov farmakološko aktivnih snovi, za katere so bile določene mejne vrednosti ostankov v skladu s členom 13
for detecting residues of pharmacologically active substances for which maximum residue limits have been determined in accordance with Article 13
te uredbe
of this Regulation
Dajanje v promet živil
Circulation of foodstuff
v promet živil živalskega izvora
prohibit ▌ the import and placing on the market of food of animal origin
, ki vsebujejo ostanke, ki so posledica nazakonitega dajanja farmakološko aktivnih snovi, ki niso predmet razvrstitve v skladu s členom 13(2)(a), (b) ali (c)
containing residues resulting from the illegal administration of pharmacologically active substances which are not subject to a classification in accordance with Article 13(2)(a), (b) or (c).
REFERENČNE TOČKE ZA UKREPE
REFERENCE POINTS FOR ACTION
Vzpostavitev in preverjanje
Establishment and review
Kadar je potrebno zagotoviti delovanje nadzora živil živalskega izvora, uvoženih ali danih v promet, v skladu z Uredbo (ES) št. 882/2004, lahko Komisija vzpostavi referenčne točke za ukrepe za ostanke farmakološko aktivnih snovi, ki niso predmet razvrstitve v skladu s členom 13(2)(a), (b) ali (c).
When it is appropriate 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 13(2)(a), (b) or (c).
Navedeni ukrepi za spremembo nebistvenih določb te uredbe se sprejmejo v skladu z regulativnim postopkom s pregledom iz
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
Referenčne točke za ukrepe se ▌preverjajo glede na
The reference points for action shall be reviewed in the light of
vse nove podatke v zvezi z varovanjem zdravja ljudi in prehranjevalne verige
any new data concerning the protection of human health and the food chain
Metode za vzpostavitev referenčnih točk za ukrepe
Methods for establishing reference points for action
Komisija lahko Evropski agenciji za varnost hrane posreduje zahtevek za oceno tveganja, ali so referenčne točke za ukrepe ustrezne za varovanje zdravja ljudi.
The Commission may forward a request to the European Food Safety Authority for a risk assessment as to whether the reference points for action are adequate to protect human health.
Evropska agencija za varnost hrane v tem primeru posreduje mnenje Komisiji v 210 dneh od prejema zahtevka.
In those cases the European Food Safety Authority shall ensure that the opinion is given to the Commission within 210 days after receipt of the request.
Ocena tveganja upošteva pravila
The risk assessment shall take account of rules
, vključno z znanstvenimi metodami
including scientific methods
, ki jih mora Komisija sprejeti v posvetovanju z Evropsko agencijo za varnost hrane.
to be adopted by the Commission in consultation with the European Food Safety Authority.
Navedena pravila za spremembo nebistvenih določb te uredbe z njeno dopolnitvijo se sprejmejo v skladu z regulativnim postopkom s pregledom iz
Those rules, 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
Prispevek Skupnosti podpornim ukrepom za referenčne točke za ukrepe
Community contribution to the support measures for reference points for action
Če uporaba tega naslova zahteva od Skupnosti financiranje ukrepov za podporo vzpostavitvi in delovanju referenčnih točk za ukrepe, se uporablja člen 66(1)(c) Uredbe (ES) št. 882/2004.
If the application of this Title requires the Community to finance measures in support of the establishment and functioning of the reference points for action, Article 66(1)(c) of Regulation (EC) No 882/2004 shall apply.
Ko je opravljen nadzor nad živili živalskega izvora, rezultati analiz pa so potrdili prisotnost farmakološko aktivne snovi, ki ne spada v razvrstitev iz člena 13(2)(a), (b) ali (c) na enaki ali višji stopnji od praga za ukrepanje, se šteje, da zadevna živila niso v skladu z zakonodajo Skupnosti.
Where checks are carried out on food of animal origin and the results of analytical tests confirm the presence of a pharmacologically active substance which is not subject to a classification in accordance with Article 13(2)(a), (b) or (c) at a level equal to or higher than its reference point for action, the relevant batch shall be deemed not to comply with Community legislation.
Ko se pri analizi proizvodov istega izvora ponavljajo rezultati, ki kažejo na potencialno težavo, pristojni organ o tem obvesti Komisijo in druge države članice v stalnem odboru za prehranjevalno verigo in zdravje živali.
Where the results of analytical tests on products of the same origin show a recurrent pattern indicating a potential problem, the competent authority shall inform the Commission and the other Member States in the Standing Committee on the Food Chain and Animal Health.
Podrobni ukrepi se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 23(3).
Detailed rules shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(3).
Stalni odbor za zdravila za uporabo v veterinarski medicini
Standing Committee on Veterinary Medicinal Products
Komisiji pomaga Stalni odbor za zdravila za uporabo v veterinarski medicini.
The Commission shall be assisted by the Standing Committee on Veterinary Medicinal Products.
Rok iz člena 5(6) Sklepa 1999/468/ES je en mesec.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month.
Pri sklicevanju na ta odstavek se uporabljata člen 5a (1) do (4) in člen 7 Sklepa 1999/468/ES ob upoštevanju določb člena 8 Sklepa.
Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Stalni odbor za prehranjevalno verigo in zdravje živali
Standing Committee on the Food Chain and Animal Health
Pri sklicevanju na ta odstavek se uporabljata člen 5a (1) do (4) in člen 7 Sklepa 1999/468/ES ob upoštevanju določb člena 8 Sklepa.
Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Razvrstitev farmakološko aktivnih snovi po Uredbi 2377/90/(EGS)
Classification of pharmacologically active substances under Regulation 2377/90(EEC)
v skladu z regulativnim postopkom
, the Commission shall adopt, in accordance with the regulatory procedure
sprejme uredbo, ki vsebuje farmakološko aktivne snovi in njihovo razvrstitev glede na mejne vrednosti ostankov v skladu s prilogami I do IV Uredbe (EGS) št. 2377/90.
, a Regulation containing the pharmacologically active substances and their classification regarding maximum residues limits in accordance with Annexes I to IV of Regulation (EEC) No 2377/90.
Komisija najpozneje
The Commission shall, by ...
Pet let po začetku veljavnosti te uredbe.
Five years after the entry into force of this Regulation.
Evropskemu parlamentu in Svetu posreduje poročilo.
, submit a report to the European Parliament and the Council.
Uredba (EGS) št. 2377/90 se razveljavi.
Regulation (EEC) No 2377/90 is repealed.
Priloge I do IV k razveljavljeni uredbi se uporabljajo do začetka veljavnosti uredbe iz
Annexes I to IV to the repealed Regulation shall continue to apply until the entry into force of the Regulation referred to in
Priloga V k razveljavljeni uredbi se uporablja do začetka veljavnosti ukrepov iz člena 12(1).
Annex V to the repealed Regulation shall continue to apply until the entry into force of the measures referred to in Article 12(1).
Sklicevanja na razveljavljeno uredbo se razlagajo kot sklicevanja na to uredbo in uredbo iz
References to the repealed Regulation shall be construed as references to this Regulation and to the Regulation referred to in
Zakonodajna resolucija Evropskega parlamenta z dne 17. junija 2008 o predlogu Sklepa Evropskega parlamenta in Sveta o evropskem letu boja proti revščini in socialni izključenosti (2010) ( KOM(2007)0797 – C6-0469/2007 – 2007/0278(COD) )
European Parliament legislative resolution of 17 June 2008 on the proposal for a decision of the European Parliament and of the Council on the European Year for Combating Poverty and Social Exclusion (2010) ( COM(2007)0797 – C6-0469/2007 – 2007/0278(COD) )
ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2007)0797 ),
having regard to the Commission proposal to the European Parliament and the Council ( COM(2007)0797 ),
ob upoštevanju členov 251(2) in 137(2) Pogodbe ES, na podlagi katerih je Komisija poslala predlog Parlamentu ( C6-0469/2007 ),
having regard to Article 251(2) and Article 137(2) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6-0469/2007 ),
ob upoštevanju poročila Odbora za zaposlovanje in socialne zadeve ter mnenja Odbora za pravice žensk in enakost spolov ( A6-0173/2008 ),
having regard to the report of the Committee on Employment and Social Affairs and the opinion of the Committee on Women's Rights and Gender Equality ( A6-0173/2008 ),
poziva Komisijo, naj zadevo ponovno predloži Parlamentu, če namerava svoj predlog bistveno spremeniti ali nadomestiti z drugim besedilom;
Takes note of the Commission statement annexed hereto;
naroči svojemu predsedniku, naj stališče Parlamenta posreduje Svetu in Komisiji.
Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;
(Ker je bil dosežen sporazum med Parlamentom in Svetom, je stališče Parlamenta iz prve obravnave enako končnemu zakonodajnemu aktu, Sklepu št. 1098/2008/ES.)
(As an agreement was reached between Parliament and Council, Parliament's position at first reading corresponds to the final legislative act, Decision No 1098/2008/EC.)
Komisija pripisuje velik pomen lajšanju in spodbujanju široke udeležbe na vseh ravneh pri dejavnostih, povezanih z evropskim letom boja proti revščini in socialni izključenosti 2010, kar je praktičen način za zagotovitev, da bo njegov učinek pozitiven in trajen.
The Commission attaches the greatest importance to facilitating and supporting wide participation at all levels in activities connected with the 2010 European Year for Combating Poverty and Social Exclusion as a practical means of ensuring that its impact is positive and lasting.
V tem okviru želi Komisija izpostaviti pomen lažjega dostopa za vse nevladne organizacije, vključno z majhnimi in srednje velikimi.
In that context, the Commission will underline the importance of facilitating access by all NGOs, including small and medium-sized organisations.
Da bi zagotovili kar najširši možen dostop, se lahko nacionalni izvršni organi odločijo, da ne bodo zaprosili za sofinanciranje, ampak bodo namesto tega v celoti financirali nekatere ukrepe.
With a view to ensuring the widest possible access, the NIBs can decide not to request any co-financing and instead to fully fund certain actions.
Zakonodajna resolucija Evropskega parlamenta z dne 17. junija 2008 o predlogu Sklepa Sveta v skladu s členom 122(2) Pogodbe o uvedbi enotne valute na Slovaškem 1. januarja 2009 ( KOM(2008)0249 – C6-0198/2008 – 2008/0092(CNS) )
European Parliament legislative resolution of 17 June 2008 on the proposal for a Council decision in accordance with Article 122(2) of the Treaty on the adoption by Slovakia of the single currency on 1 January 2009 ( COM(2008)0249 – C6-0198/2008 – 2008/0092(CNS) )
ob upoštevanju predloga Komisije Svetu ( KOM(2008)0249 ),
having regard to the Commission proposal to the Council ( COM(2008)0249 ),
ob upoštevanju konvergenčnega poročila Komisije o Slovaški za leto 2008 ( KOM(2008)0248 ) in konvergenčnega poročila Evropske centralne banke iz maja 2008,
having regard to the Commission Convergence Report 2008 ( COM(2008)0248 ) as regards Slovakia and the European Central Bank (ECB) Convergence Report of May 2008,
ob upoštevanju priporočila Komisije za sklep Sveta o odpravi Sklepa 2005/182/ES o obstoju čezmernega primanjkljaja na Slovaškem ( SEK(2008)0572 ),
having regard to the Recommendation for a Council Decision abrogating Decision 2005/182/EC on the existence of an excessive deficit in Slovakia ( SEC(2008)0572 ),
ob upoštevanju svoje resolucije z dne 12. julija 2007 o letnem poročilu o euroobmočju za leto 2007 Sprejeta besedila, P6_TA(2007)0348 .
having regard to its resolution of 12 July 2007 on the 2007 annual report on the eurozone Texts adopted, P6_TA(2007)0348 .