natgillin/translations-raw huggingface dataset:
o skupnem stališču Sveta z namenom sprejetja Uredbe Evropskega parlamenta in Sveta o določitvi postopkov Skupnosti za določitev vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora in razveljavitvi Uredbe (EGS) št. 2377/90 in spremembi Direktive 2001/82/ES Evropskega parlamenta in Sveta ter Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
on the Council common position for adopting a regulation of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council
– ob upoštevanju skupnega stališča Sveta (15079/2/2008 – C6‑0005/2009 ),
– having regard to the Council common position (15079/2/2008 – C6‑0005/2009 ),
Sprejeta besedila, 17.6.2008, P6_TA(2008)0285 . o predlogu Komisije Parlamentu in Svetu ( KOM(2007)0194 ),
Texts adopted, 17.6.2008, P6_TA(2008)0285 . on the Commission proposal to Parliament and the Council ( COM(2007)0194 ),
– ob upoštevanju priporočila za drugo obravnavo Odbora za okolje, javno zdravje in varnost hrane ( A6‑0048/2009 )
– having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety ( A6‑0048/2009 ),
Cilj predloga Komisije je omejiti izpostavljenost potrošnikov farmakološko aktivnim snovem, namenjenim za uporabo v zdravilih za uporabo v veterinarski medicini za živali za proizvodnjo živil in njihovih ostankov v živilih živalskega izvora.
The aim of the Commission proposal is to limit the exposure of consumers to pharmacologically active substances intended for use in veterinary medicinal products for food producing animals as well as residues thereof in foodstuffs of animal origin.
V skladu z načeli boljše priprave zakonodaje pa je treba tudi izboljšati berljivost in jasnost obstoječe zakonodaje.
Finally, and in accordance with the principles of better regulation, the readability and clarity of the existing legislation should be improved.
Medtem ko je Evropski parlament precej enostavno in hitro dosegel soglasje na osnovi poročila, ki ga je sprejel odbor za okolje, je bil v Svetu potreben obsežen notranji posvet v času portugalskega in slovenskega predsedovanja in skupno stališče je bilo pripravljeno šele v času francoskega predsedovanja v drugi polovici leta 2008.
Whereas the European Parliament was able to reach a consensus with relative ease and speed based upon the report adopted in the Environment Committee, Council required considerable internal deliberation under the Portuguese and Slovene Presidencies and was only able to conclude its Common Position under the French Presidency in the second half of 2008.
Skupno stališče izhaja iz številnih neformalnih trialogov s Svetom in Komisijo, ki so se zaključili oktobra 2008.
This was the result of a series of informal trilogues with the Council and the Commission which were concluded in October 2008.
Besedilo skupnega stališča, ki ga je Svet odobril 18. decembra 2008 in je bilo 15. januarja 2009 objavljeno v Evropskem parlamentu, v celoti odraža kompromis, dosežen na pogajanjih med tremi institucijami.
The Common Position text approved on the 18 December 2008 by the Council, and announced in the European Parliament on 15 January 2009, fully reflects the compromise achieved through negotiation between the three institutions.
Ta zadeva, ki se sprejema s postopkom soodločanja, se torej lahko zaključi kot zgodnji dogovor v drugi obravnavi z glasovanjem o kompromisnem svežnju najprej v odboru za okolje in nato na plenarnem zasedanju, kot je bilo dogovorjeno na neformalnem trialogu in prikazano v besedilu skupnega stališča.
This codecision file can therefore be concluded as an early second reading agreement by a vote on the compromise package, as agreed in the informal trilogue and reflected in the Common Position text, in the Environment Committee and subsequently the Plenary.
Ključna vprašanja
Key issues
V novem besedilu so naslednje ključne teme:
The key points addressed in the new text are as follows:
- referenčne vrednosti za ukrepe: sedaj so opredeljene kot 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.
- reference points for action : this is now defined as 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.
Parlament je dodal člen o izvajanju referenčnih vrednosti za ukrepe.
In addition, Parliament introduced a new Article on implementing reference points for action.
Referenčne vrednosti za ukrepe se preverjajo glede na vse nove podatke v zvezi z varovanjem zdravja ljudi in prehranjevalne verige;
The reference points for action shall be reviewed in the light of any new data concerning the protection of human health and the food chain;
- Evropska agencija za varnost hrane: v priporočilih za obvladovanje tveganja je treba preko pisem o sodelovanju upoštevati vsa ustrezna znanstvena dognanja Evropske agencije za varnost hrane;
- European Food Safety Authority: the risk management recommendations should take into account any relevant scientific findings of the European Food Safety Authority, by way of letters of cooperation;
- znanstvena ocena tveganja: v skladu s členi 4 do 8 se za zagotovitev visoke ravni varovanja zdravja uporabljajo načela za oceno tveganja;
- scientific risk assessment: the principles of risk assessment pursuant to Articles 4 to 8 shall be applied in order to guarantee a high level of health protection;
- upoštevati je treba tveganje toksikoloških, farmakoloških ali mikrobioloških učinkov pri ljudeh;
- toxicological, as well as pharmacological or microbiological effects in human beings should be considered;
- kopitarji: nova klavzula navaja, da je nominalna karenca pri zdravilih za uporabo v veterinarski medicini, ki nimajo mejne vrednosti ostankov za kopitarje, niso vključena v Prilogo IV Uredbe (EGS) št. 2377/90 ali člen 13(2) te uredbe in katerih uporaba „ni v skladu s povzetkom značilnosti zdravil“, kakor je opredeljeno v členu 1(16) Direktive 2001/82/ES, in se uporabljajo „v skladu s določbami kaskadnega postopka“ ter se ne dajejo v mišico ali podkožno, šest mesecev.
- equidae: a new clause states that veterinary medicinal products which do not have a maximum residue limit for equidae, which are not included in Annex IV of Regulation (EEC) No 2377/90 or in Article 13(2) of this Regulation, and which are used "off-label", as defined in Article 1(16) of Directive 2001/82/EC, and "under the provisions of the cascade" and not administered intra-muscularly or subcutaneously, shall have a nominal withdrawal period of six months.
Poleg tega je nominalna karenca za uporabo farmacevtskih izdelkov s farmakološko aktivnimi sestavinami, ki niso na seznamu „bistvenih“ snovi ali na „pozitivnem seznamu“ za kopitarje iz člena 10(3) Direktive 2001/82/ES in se ne dajejo v mišico ali podkožno, šest mesecev, če se domneva, da imajo klinično korist;
Furthermore, the use of pharmaceuticals containing pharmacologically active ingredients not on "the essential" substances list or the "positive list" for equidae referred to in Article 10(3) of Directive 2001/82/EC and not administered intra-muscularly or subcutaneously, shall have a nominal withdrawal period of six months if deemed of clinical benefit.
- nujno dovoljenje: v posebnih primerih, kjer je dovoljenje nujno za zagotovitev varovanja zdravja ljudi ter zdravja in dobrega počutja živali, lahko Komisija v skladu z regulativnim postopkom s pregledom določi začasno najvišjo mejno vrednost za obdobje največ pet let;
- urgent authorisation: in specific cases where urgent authorisation is required to ensure the protection of human health and animal health and welfare, the Commission may, in accordance with the regulatory procedure with scrutiny, establish a provisional maximum residue limit for a period not exceeding five years;
- zahtevek za mnenje o najvišjih mejnih vrednostih ostankov: predlog navaja, da lahko Komisija ali države članice agenciji posredujejo zahtevke za mnenje o snoveh, ki niso namenjene za uporabo v zdravilih za uporabo v veterinarski medicini, ki se dajejo na trg Skupnosti, kadar ni bila predložena nobena vloga za takšne snovi.
- requests for an opinion on maximum residue limits: the proposal had stated that the Commission or Member States may forward to the Agency requests for an opinion for substances not intended for use in veterinary medicinal products to be placed on the market in the Community and where no application for such substances has been made.
Parlament je dodal besedilo, ki navaja, da Komisija, države članice ali tretja stran, ki zastopa upravičene interese, lahko posredujejo agenciji zahtevke za mnenje o mejnih vrednostih ostankov za farmakološko aktivne snovi v primerih, ki so predvideni v besedilu;
Parliament introduced wording which states that the Commission, Member States or a third party pursuing legitimate interests may forward to the Agency requests for an opinion on MRLs for pharmacologically active substances in certain circumstances which are prescribed in the text;
- komitologija: opredelitev metodologije ocene tveganja in obvladovanja tveganja se opravi v skladu z regulativnim postopkom s pregledom.
- comitology: defining the methodology of the risk assessment and of risk management will be done in accordance with the regulatory procedure with scrutiny.
Poleg tega je Parlament je spremenil časovne omejitve za sprejetje sklepov;
Moreover, Parliament altered the time limits for the adoption of decisions;
- pospešeni postopek za mnenje agencije: nova klavzula navaja, da v posebnih primerih, ko je treba zdravilo za uporabo v veterinarski medicini ali biocidni proizvod nujno odobriti zaradi varovanja zdravja ljudi oziroma zdravja ali dobrega počutja živali, lahko Komisija, vsaka oseba, ki je zahtevala mnenje, ali država članica agencijo zaprosi za izvedbo pospešenega postopka za oceno najvišje mejne vrednosti ostanka farmakološko aktivne snovi, vsebovane v teh pripravkih.
- accelerated procedure for an Agency opinion: a new clause states that, 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 requested an opinion, 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.
Agencija zagotovi, da odbor poda svoje mnenje v 150 dneh po prejemu vloge;
The Agency shall ensure that the Committee is able to issue its opinion within 150 days following receipt of the application;
- dajanje v promet: nov člen navaja, da če so mejne vrednosti ostankov ali referenčne količine, ki so bile določene v skladu s to uredbo, presežene, se proizvod ne sme dati v promet kot živilo, predelati v živilo oziroma mešati z živili.
- placing on the market: a new Article states that if the maximum residue limits or reference quantities established under this Regulation are exceeded, the product shall not be placed on the market as a foodstuff, transformed into foodstuffs or mixed with foodstuffs.
Živila živalskega izvora, ki vsebujejo farmakološko aktivne snovi, za katere mejne vrednosti ostankov niso bile določene, se ne smejo dati v promet;
Foodstuffs of animal origin containing pharmacologically active substances for which no maximum residue limits have been set may not be placed on the market;
- uvoz: Države članice prepovejo uvoz in dajanje v promet živil živalskega izvora, ki vsebujejo ostanke, ki so posledica nezakonitega dajanja farmakološko aktivnih snovi, ki niso predmet razvrstitve v skladu z besedilom.
- import: Member States shall prohibit the import and placing on the market of food of animal origin containing residues resulting from the illegal administration of pharmacologically active substances which are not subject to a classification in accordance with the text.
V skladu s tem je zaradi varovanja javnega zdravja prepovedan uvoz živil iz tretjih držav, ki vsebujejo ostanke, ki so posledica nezakonitega dajanja snovi, katerih uporaba je prepovedana v Evropski uniji;
Accordingly, imports from third countries of food containing residues resulting from the illegal administration of substances whose use is use is banned within the European Union shall be prohibited in the interests of public health;
- poročilo: Komisija najkasneje v petih letih po začetku veljavnosti te uredbe Evropskemu parlamentu in Svetu predloži poročilo, v katerem zlasti pregleda izkušnje, pridobljene z uporabo uredbe, in po potrebi priloži predloge.
- report: the Commission shall, not later than five years after the entry into force of the Regulation, submit a report which will, in particular, review the experience gained from the application of the Regulation, and, if appropriate, be accompanied by proposals.
Priporočilo poročevalke
Rapporteur's recommendation
Poročevalka Avril Doyle (PPE-DE, Irska) priporoča, da se v odboru za okolje in na plenarnem zasedanju skupno stališče sprejme v svežnju, brez sprememb ali predlogov sprememb, saj v celoti odraža sporazum, ki je bil dosežen s Svetom in Komisijo.
The rapporteur, Avril Doyle (EPP-ED, IE), recommends the adoption en bloc of the Common Position by the Environment Committee and the Plenary without modification or amendment as it reflects in its entirety the agreement reached with Council and the Commission.
o predlogu Sklepa Sveta o podpisu in začasni uporabi Sporazuma med Evropsko skupnostjo in Republiko Armenijo o nekaterih vidikih zračnega prevoza
on the proposal for a Council decision on the conclusion of the Agreement between the European Community and the Republic of Armenia on certain aspects of air services
– ob upoštevanju predloga Sklepa Sveta ( KOM(2007)0729 ),
– having regard to the proposal for a Council decision ( COM(2007)0729 ),
– ob upoštevanju prvega pododstavka člena 300(3) Pogodbe o ES, v skladu s katerim se je Svet posvetoval s Parlamentom ( C6-0519/2008 ),
– having regard to Article 300(3), first subparagraph, of the EC Treaty, pursuant to which the Council consulted Parliament ( C6‑0519/2008 ),
– ob upoštevanju člena 51, člena 83(7) in člena 43(1) svojega poslovnika,
– having regard to Rules 51, 83(7) and 43(1) of its Rules of Procedure,
– ob upoštevanju poročila Odbora za promet in turizem ( A6-0049/2009 ),
– having regard to the report of the Committee on Transport and Tourism ( A6‑0049/2009 ),
Komisija je tako na pogajanjih z vlado Republike Armenije dosegla sporazum, ki nadomešča nekatere določbe iz obstoječih dvostranskih sporazumih o zračnem prevozu med državami članicami in Republiko Armenijo.
Thus, the Commission has negotiated an Agreement with the Government of Republic of Armenia that replaces certain provisions in the existing bilateral air services agreements between Member States and Republic of Armenia.
Člen 5 (tarife): člen odpravlja neskladje med dvostranskimi sporazumi in Uredbo Sveta (EGS) 2409/92 o prevozninah in tarifah za zračni prevoz.
Article 5 (pricing): Resolves conflicts between the bilateral agreements and Council Regulation (EEC) 2409/92 on fares and rates for air services.
Sporazum določa, da se za tarife, ki jih zaračunajo letalski prevozniki, ki jih določi Republika Armenija, uporablja pravo Evropske skupnosti za prevoz, ki se v celoti odvija znotraj Evropske skupnosti.
The agreement stipulates that tariffs to be charged by the air carriers designated by the Republic of Armenia for carriage wholly within the European Community shall be subject to European Community law.
Prilogi 1 in 2 vsebujeta seznam dvostranskih sporazumov in njihovih členov, ki so navedeni v členih 1 do 5 predlaganega sporazuma: to so sporazumi med Republiko Armenijo in Avstrijo, Belgijo, Češko republiko, Dansko, Estonijo, Francijo, Grčijo, Italijo, Luksemburgom, Nemčijo, Nizozemsko, Poljsko, Romunijo, Švedsko in Združenim kraljestvom.
Annex 1 and 2 list the bilateral agreements and their articles which are referred to in Articles 1 to 5 of the proposed Agreement; these are the agreements between Republic of Armenia and Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Poland, Romania, Sweden and United Kingdom.
V Prilogi 3 so navedene ostale države iz člena 2: Islandija, Lihtenštajn in Norveška, ki jih zadeva Sporazum o Evropskem gospodarskem prostoru, ter Švica, ki jo zadeva Sporazum med Evropsko skupnostjo in Švicarsko konfederacijo o zračnem prevozu.
Annex 3 lists the other states referred to in Article 2: Iceland, Liechtenstein, Norway -which fall under the Agreement on the European Economic Area- and Switzerland falling under the Agreement between the European Community and the Swiss Confederation on Air Transport.
Sporazum, ki ga je v pogajanjih dosegla Komisija, je bil podpisan in ga je treba začasno uporabljati.
The Agreement negotiated by the Commission has been signed and should be provisionally applied.
Predlagani sklep Sveta pooblašča predsednika Sveta, da določi pristojno osebo ali osebe, ki v imenu Skupnosti obvestijo Republiko Armenijo o dokončanju potrebnih notranjih postopkov, da sporazum začne veljati.
The proposed Council Decision empowers the President of the Council to designate the person or persons competent to notify Republic of Armenia that the internal procedures necessary for the entry into force of the Agreement have been completed.
Na podlagi navedenega poročevalec predlaga, da Odbor za promet in turizem poda pozitivno mnenje o sklenitvi tega sporazuma.
On the basis of the above your rapporteur suggests that the TRAN committee should give a favourable opinion on the conclusion of this Agreement.
Sporazum ES/Armenija o nekaterih vidikih zračnega prevoza
Agreement between the EC and Armenia on certain aspects of air services
o prihodnosti skupnega evropskega azilnega sistema
on the future of the European Common Asylum System
MNENJE Odbora za razvoj ...........................................................................................11
OPINION of the Committee on Development ......................................................12
– ob upoštevanju člena 63(1) in (2) Pogodbe o EU,
– having regard to Article 63, paragraphs 1 and 2, of the EU Treaty,
– ob upoštevanju Ženevske konvencije iz leta 1951 o statusu beguncev in dodatnega protokola k tej konvenciji iz leta 1967,
– having regard to the 1951 Geneva Convention relating to the Status of Refugees, and the 1967 Additional Protocol thereto,
UL L 31, 06.02.2003, str.
OJ L 31, 6.2.2003, p.
– ob upoštevanju Direktive Sveta 2004/83/ES z dne 29. aprila 2004 o minimalnih standardih glede pogojev, ki jih morajo izpolnjevati državljani tretjih držav ali osebe brez državljanstva, da se jim prizna status begunca ali osebe, ki iz drugih razlogov potrebuje mednarodno zaščito, in o vsebini te zaščite
– having regard to Council Directive 2004/83/EC of 29 April 2004 on minimum standards for the qualification and status of third country nationals or stateless persons as refugees or as persons who otherwise need international protection and the content of the protection granted
UL L 304, 30.09.2004, str.
OJ L 304, 30.9.2004, p.
– ob upoštevanju poročila Komisije Svetu in Evropskemu parlamentu o uporabi Direktive 2003/9/ES z dne 27. januarja 2003 o minimalnih standardih za sprejem prosilcev za azil ( KOM(2007)0745 ),
– having regard to the report from the Commission to the Council and to the European Parliament on the application of Directive 2003/9/EC of 27 January 2003 laying down minimum standards for the reception of asylum seekers ( COM(2007)0745 ),
– ob upoštevanju svoje resolucije z dne 6. aprila 2006 o razmerah v begunskih taboriščih na Malti
– having regard to its resolution of 6 April 2006 on the situation with refugee camps in Malta
UL C 293 E, 02.12.2006, str.
OJ C 293 E, 2.12.2006, p.
– ob upoštevanju svoje resolucije z dne 2. septembra 2008 o oceni dublinskega sistema
– having regard to its Resolution of 2 September 2008 on the evaluation of the Dublin system
Sprejeta besedila na ta dan, P6_TA-PROV(2008)0385 . ,
Texts adopted of that date, P6_TA-PROV(2008)0385 . ,
– ob upoštevanju poročil Odbora za državljanske svoboščine, pravosodje in notranje zadeve o obiskih v različnih centrih za pridržanje, da bi se preverili pogoji sprejema,
– having regard to the reports of the Committee on Civil Liberties, Justice and Home Affairs on the visits to various holding centres in order to monitor reception conditions,
– ob upoštevanju sodbe Sodišča Evropskih skupnosti z dne 6. maja 2008 v zadevi C 133/06, Evropski parlament proti Svetu Evropske unije
– having regard to the judgment of the Court of Justice of the European Communities of 6 May 2008 in Case C-133/06, European Parliament v Council of the European Union
UL C 158, 21.6.2008, str.
OJ C 158, 21.6.2008, p.
3. , o tožbi za razveljavitev direktive št. 2005/85/ES o minimalnih standardih glede postopkov za priznanje ali odvzem statusa begunca v državah članicah, predvsem za razveljavitev določb direktive o postopku sprejetja in spremembi skupnih najosnovnejših seznamov varnih držav članic,
3. concerning an action for annulment of Directive 2005/85/EC on minimum standards on procedures in Member States for granting and withdrawing refugee status, seeking in particular annulment of the directive's provisions on the procedure for adoption and amendment of minimum common lists of safe countries,
– ob upoštevanju Evropskega pakta o priseljevanju in azilu, ki ga je Evropski svet sprejel 16. oktobra 2008 in katerega četrti cilj je „zgraditi Evropo azila“,
– having regard to the European Pact on Immigration and Asylum adopted by the European Council on 16 October 2008, whose fourth objective is to 'construct a Europe of Asylum',
– ob upoštevanju poročila Odbora za državljanske svoboščine, pravosodje in notranje zadeve ter mnenja Odbora za razvoj ( A6-0050/2009 ),
– having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs and the opinion of the Committee on Development ( A6‑0050/2009 ),
A. ker so zakonodajni instrumenti prve faze vzpostavitve skupnega evropskega azilnega sistema omogočili sprejetje skupnih minimalnih standardov, ne pa tudi enakih pogojev dostopa do zaščite na celotnem ozemlju Unije, zaradi česar še vedno prihaja do naknadnega gibanja in večkratnih prošenj,
A. whereas the legislative instruments relating to the first phase of the establishment of the common European asylum system have allowed the introduction of common minimum standards but not of equal conditions of access to protection throughout the EU and, as a result, there are still problems such as secondary movements and multiple applications,
B. ker utegnejo biti zaradi meril o državi prvega vstopa v okviru dublinskega sistema nekatere države članice, zlasti tiste, ki so na zunanji meji EU, nesorazmerno obremenjene zgolj zaradi svoje izpostavljene geografske lege, in ker ima to škodljive posledice tako za države članice kot za prosilce za azil,
B. whereas the Dublin system's first country of entry criteria can result in a disproportionate burden being imposed on some Member States, in particular on those representing the external EU border, simply as a result of their exposed location, and whereas this has harmful consequences for both Member States and asylum seekers,
C. ker ocena Komisije razkriva, da je moralo leta 2005 trinajst mejnih držav članic obravnavati rastoče izzive, ki izhajajo iz dublinskega sistema,
C. whereas the Commission evaluation reveals that, in 2005, the 13 border Member States had to deal with increasing challenges raised by the Dublin system,