natgillin/translations-raw huggingface dataset:
The applications for import licences lodged during the first seven days of June 2012 for the subperiod from 1 July to 30 September 2012 relate, for some quotas, to quantities exceeding those available.
Količine v zahtevkih za uvozna dovoljenja, predloženih v prvih sedmih dneh meseca junija 2012 za podobdobje od 1. julija do 30. septembra 2012, so pri nekaterih kvotah višje od razpoložljivih.
The quantities for which import licence applications have been lodged under Regulation (EC) No 533/2007 for the subperiod from 1 July to 30 September 2012 shall be multiplied by the allocation coefficients set out in the Annex to this Regulation.
Za zahtevke za uvozna dovoljenja, ki so v skladu z Uredbo (ES) št. 533/2007 predloženi za podobdobje od 1. julija do 30. septembra 2012 se uporabijo koeficienti dodelitve iz Priloge k tej uredbi.
This Regulation shall enter into force on 19 June 2012.
Ta uredba začne veljati 19. junija 2012.
Allocation coefficient for import licence applications lodged for the subperiod from 1.7.2012-30.9.2012
Koeficient dodelitve za zahtevke za uvozna dovoljenja, predložene za podobdobje od 1.7.2012-30.9.2012
Commission Implementing Regulation (EU) No 517/2012
Izvedbena uredba Komisije (EU) št. 517/2012
on the issue of import licences for applications lodged during the first seven days of June 2012 under the tariff quotas opened by Regulation (EC) No 539/2007 for certain products in the egg sector and for egg albumin
o izdaji uvoznih dovoljenj na podlagi zahtevkov, predloženih v prvih sedmih dneh meseca junija 2012 v okviru tarifnih kvot za nekatere proizvode v sektorju za jajca in jajčni albumin, odprtih z Uredbo (ES) št. 539/2007
The quantities for which import licence applications have been lodged under Regulation (EC) No 539/2007 for the subperiod from 1 July to 30 September 2012 shall be multiplied by the allocation coefficients set out in the Annex hereto.
Za zahtevke za uvozna dovoljenja, ki so v skladu z Uredbo (ES) št. 539/2007 predloženi za podobdobje od 1. julija do 30. septembra 2012, se uporabijo koeficienti dodelitve iz Priloge k tej uredbi.
Commission Implementing Regulation (EU) No 518/2012
Izvedbena uredba Komisije (EU) št. 518/2012
on the issue of import licences for applications lodged during the first seven days of June 2012 under the tariff quota opened by Regulation (EC) No 1385/2007 for poultrymeat
o izdaji uvoznih dovoljenj na podlagi zahtevkov, predloženih v prvih sedmih dneh meseca junija 2012 v okviru tarifne kvote za perutninsko meso, odprte z Uredbo (ES) št. 1385/2007
The quantities for which import licence applications have been lodged for the subperiod from 1 July to 30 September 2012 under Regulation (EC) No 1385/2007 shall be multiplied by the allocation coefficients set out in the Annex hereto.
Za zahtevke za uvozna dovoljenja, ki so v skladu z Uredbo (ES) št. 1385/2007 predloženi za podobdobje od 1. julija do 30. septembra 2012, se uporabijo koeficienti dodelitve iz Priloge k tej uredbi.
Commission Regulation (EU) No 519/2012
Uredba Komisije (EU) št. 519/2012
amending Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants as regards Annex I
o spremembi Uredbe Evropskega parlamenta in Sveta (ES) št. 850/2004 o obstojnih organskih onesnaževalih glede Priloge I
Having regard to Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC [1], and in particular Articles 14(1) and 14(3) thereof,
ob upoštevanju Uredbe Evropskega parlamenta in Sveta (ES) št. 850/2004 z dne 29. aprila 2004 o obstojnih organskih onesnaževalih in spremembi Direktive 79/117/EGS [1] ter zlasti člena 14(1) in člena 14(3) Uredbe,
Regulation (EC) No 850/2004 implements in the law of the Union the commitments set out in the Stockholm Convention on Persistent Organic Pollutants (hereinafter ‘the Convention’) approved by Council Decision 2006/507/EC of 14 October 2004 concerning the conclusion, on behalf of the European Community, of the Stockholm Convention on Persistent Organic Pollutants [2] and in the 1998 Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants (hereinafter ‘the Protocol’) approved by Council Decision 2004/259/EC of 19 February 2004 concerning the conclusion, on behalf of the European Community, of the Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants [3] (hereinafter ‘CLRTAP’).
Uredba (ES) št. 850/2004 v pravo Unije prenaša zaveze iz Stockholmske konvencije o obstojnih organskih onesnaževalih (v nadaljnjem besedilu: Konvencija), ki je bila potrjena s Sklepom Sveta 2006/507/ES z dne 14. oktobra 2004 o sklenitvi, v imenu Evropske skupnosti, Stockholmske konvencije o obstojnih organskih onesnaževalih [2], in iz Protokola iz leta 1998 o obstojnih organskih onesnaževalih h Konvenciji iz leta 1979 o onesnaževanju zraka na velike razdalje prek meja (v nadaljnjem besedilu: Protokol), ki je bil potrjen s Sklepom Sveta 2004/259/ES z dne 19. februarja 2004 o sklenitvi Protokola o obstojnih organskih onesnaževalih h Konvenciji iz leta 1979 o onesnaževanju zraka na velike razdalje preko meja v imenu Evropske skupnosti (v nadaljnjem besedilu: CLRTAP) [3].
At its 27th Session from 14 to 18 December 2009, the CLRTAP Executive Body decided to add hexachlorobutadiene [4], polychlorinated naphthalenes (hereinafter ‘PCN’), and short-chain chlorinated paraffins [5] (hereinafter ‘SCCPs’) to the Protocol.
Izvršilni organ CLRTAP je na svoji 27. seji od 14. do 18. decembra 2009 sprejel odločitev, da vključi heksaklorobutadien [4], poliklorirane naftalene (v nadaljnjem besedilu: PCN) in klorirane parafine s kratkimi verigami [5] (v nadaljnjem besedilu: SCCP) v Protokol.
In view of the Decisions taken by the CLRTAP, it is necessary to update Annex I, Part B to Regulation (EC) No 850/2004 in order to include the three new substances listed in the Protocol.
Glede na odločitve, ki jih je sprejel CLRTAP, je treba posodobiti del B Priloge I k Uredbi (ES) št. 850/2004, da bi vključili tri nove snovi, navedene v Protokolu.
Placing on the market and use of SCCPs has been restricted in the Union by virtue of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council [6] on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
Dajanje v promet in uporaba kloriranih parafinov s kratkimi verigami sta v Uniji omejena na podlagi Priloge XVII k Uredbi (ES) št. 1907/2006 Evropskega parlamenta in Sveta [6] o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH).
The existing restriction on SCCPs in the Union covers only two uses and thus its scope is much narrower than the scope of the restriction on SCCPs established by the Decision of the CLRTAP Executive Body.
Obstoječa omejitev za klorirane parafine s kratkimi verigami v Uniji zajema le dve uporabi in tako je njen obseg precej ožji od obsega omejitev kloriranih parafinov s kratkimi verigami, ki jih je s sklepom določil izvršilni organ CLRTAP.
This Regulation should therefore widen the scope of restriction on SCCPs in the Union by prohibiting their production, placing on the market, and use, except for two exempted uses.
Zato mora ta uredba razširiti obseg omejitev kloriranih parafinov s kratkimi verigami v Uniji, tako da prepove njihovo proizvodnjo, dajanje v promet in uporabo, razen za dve izvzeti uporabi.
The 1 % threshold level established in this Regulation for SCCPs should not be considered as an implementation of the notion of ‘unintentional trace contaminant’ contained in Article 4(1)(b) of Regulation (EC) No 850/2004.
Raven praga 1 %, ki je za klorirane parafine s kratkimi verigami določena v tej uredbi, se ne sme šteti kot izvajanje pojma „nenamerna sled onesnaževalca“ iz člena 4(1)(b) Uredbe (ES) št. 850/2004.
Further scientific analysis is required before the Commission can reach a clear view with regard to the level corresponding to ‘unintentional trace contaminant’ in relation to SCCPs.
Nadaljnja znanstvena analiza je potrebna, da bo Komisija lahko dosegla jasen pogled na raven, ki ustreza „nenamerni sledi onesnaževalca“ v zvezi s kloriranimi parafini s kratkimi verigami.
The derogations for SCCPs should, where applicable, be subject to the use of the best available techniques.
Odstopanja za klorirane parafine s kratkimi verigami so po potrebi odvisna od uporabe najboljših razpoložljivih tehnik.
The Commission should continue to review those derogations and the availability of safer alternative substances or technologies.
Komisija mora nadaljevati s pregledovanjem teh odstopanj in razpoložljivosti varnejših nadomestnih snovi ali tehnologij.
At its fifth meeting from 25 to 29 April 2011, the Conference of the Parties to the Convention agreed by Decision SC-5/3 [7] to add endosulfan to the list of POPs to be eliminated worldwide, with some exemptions.
Konferenca pogodbenic Konvencije je na petem zasedanju od 25. do 29. aprila 2011 s Sklepom SC-5/3 [7] sklenila, da doda endosulfan na seznam obstojnih organskih onesnaževal, ki jih je z nekaterimi izjemami treba odpraviti po vsem svetu.
In view of Decision SC-5/3, it is necessary to update Annex I, Part A to Regulation (EC) No 850/2004 in order to include endosulfan.
Zaradi Sklepa SC-5/3 je treba posodobiti del A Priloge I k Uredbi (ES) št. 850/2004, da se vključi endosulfan.
However, endosulfan was subject to Commission Decision 2005/864/EC of 2 December 2005 concerning the non-inclusion of endosulfan in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisation for plant protection products containing this active substance [8].
Vendar je bil endosulfan predmet Odločbe Komisije 2005/864/ES z dne 2. decembra 2005 o nevključitvi endosulfana v Prilogo I k Direktivi Sveta 91/414/EGS in o odvzemu dovoljenj za fitofarmacevtska sredstva, ki vsebujejo to aktivno snov [8].
Endosulfan should therefore be listed in Annex I, Part A to Regulation (EC) No 850/2004 without exemptions since all the exemptions allowed under Decision SC-5/3 relate to the use of endosulfan as a plant protection product.
Endosulfan je zato treba brez izjeme uvrstiti v del A Priloge I k Uredbi (ES) št. 850/2004, saj se vse izjeme, dovoljene v skladu s Sklepom SC-5/3, navezujejo na uporabo endosulfana kot fitofarmacevtskega sredstva.
It is necessary to clarify that the prohibition in Article 3 of Regulation (EC) No 850/2004 does not apply to articles containing endosulfan, hexachlorobutadiene, PCN or SCCPs, produced before or on the date of entry into force of this Regulation until six months after the date of its entry into force.
Treba je pojasniti, da se prepoved iz člena 3 Uredbe (ES) št. 850/2004 ne uporablja za člene, ki vsebujejo endosulfan, heksaklorobutadien, PCN ali klorirane parafine s kratkimi verigami, proizvedene pred ali na datum začetka veljavnosti te uredbe do šest mesecev po datumu začetka veljavnosti.
It is also necessary to clarify that the prohibition in Article 3 of Regulation (EC) No 850/2004 does not apply to articles containing endosulfan, hexachlorobutadiene, PCN or SCCPs, already in use before or on the date of entry into force of this Regulation.
Treba je navesti tudi, da se prepoved iz člena 3 Uredbe (ES) št. 850/2004 ne uporablja za člene, ki vsebujejo endosulfan, heksaklorobutadien, PCN ali klorirane parafine s kratkimi verigami, ki so že v uporabi pred ali na datum začetka veljavnosti te uredbe.
It is necessary to adapt to technical progress the reference to the CEN standards currently under development in relation to perfluoroctane sulphonic acid and its derivates (PFOS), to allow other analytical methods with the same level of performance to be used.
Sklicevanje na standarde CEN, ki so trenutno v razvoju v zvezi s perfluorooktan sulfonsko kislino in njenimi derivati (PFOS), je treba prilagoditi tehničnemu napredku, da se lahko uporabljajo druge analitične metode z enako ravnijo učinkovitosti.
The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Council Directive 67/548/EEC [9],
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem odbora, ustanovljenega z Direktivo Sveta 67/548/EGS [9] –
Annex I to Regulation (EC) No 850/2004 is amended in accordance with the Annex to this Regulation.
Priloga I k Uredbi (ES) št. 850/2004 se spremeni v skladu s Prilogo k tej uredbi.
Done at Brussels, 19 June 2012.
V Bruslju, 19. junija 2012
Decision 2009/1.
Odločba 2009/1.
Decision 2009/2.
Odločba 2009/2.
SC-5/3 Listing technical endosulfan and its related isomers.
SC-5/3 vključuje tehnični endosulfan in sorodne soli.
Annex I to Regulation (EC) No 850/2004 is amended as follows:
Priloga I k Uredbi (ES) št. 850/2004 se spremeni:
in the entry for perfluoroctane sulphonic acid and its derivates (PFOS) point 6 in the column ‘Specific exemption on intermediate use or other specification’ is replaced by the following:
v vnosu za perfluorooktan sulfonsko kislino in njene derivate (PFOS) se točka 6 v stolpcu „Posebna izjema v zvezi s proizvodi za vmesno uporabo ali druga specifikacija“ nadomesti z naslednjim:
Any other analytical method for which the user can prove equivalent performance could be used as an alternative to the CEN standards.’;
Vsaka druga analitična metoda, za katero lahko uporabnik dokaže enakovredno zmogljivost, se lahko uporabi kot alternativa standardom CEN.“;
Placing on the market and use of articles produced before or on 10 July 2012 containing endosulfan as a constituent of such articles shall be allowed until 10 January 2013.
Dajanje v promet in uporaba izdelkov, proizvedenih pred ali na 10. julij 2012, ki vsebujejo endosulfan kot sestavni del takih izdelkov, se dovoli do 10. januarja 2013.
Placing on the market and use of articles already in use before or on 10 July 2012 containing endosulfan as a constituent of such articles shall be allowed.
Dajanje v promet in uporaba izdelkov, v uporabi že pred ali na 10. julij 2012, ki vsebujejo endosulfan kot sestavni del takih izdelkov, se dovoli.
Article 4(2), third and fourth subparagraphs shall apply to articles referred to in paragraphs 1 and 2.’
Za izdelke iz odstavkov 1 in 2 se uporabljata tretji in četrti pododstavek člena 4(2).“
in Part B, the following entries are added:
v delu B se dodajo naslednji vnosi:
Placing on the market and use of articles produced before or on 10 July 2012 containing hexachlorobutadiene as a constituent of such articles shall be allowed until 10 January 2013.
Dajanje v promet in uporaba izdelkov, proizvedenih pred ali na 10. julij 2012, ki vsebujejo heksaklorobutadien kot sestavni del takih izdelkov, se dovoli do 10. januarja 2013.
Placing on the market and use of articles already in use before or on 10 July 2012 containing hexachlorobutadiene as a constituent of such articles shall be allowed.
Dajanje v promet in uporaba izdelkov, v uporabi že pred ali na 10. julij 2012, ki vsebujejo heksaklorobutadien kot sestavni del takih izdelkov, se dovoli.
Article 4(2), third and fourth subparagraphs shall apply to articles referred to in paragraphs 1 and 2.
Za izdelke iz odstavkov 1 in 2 se uporabljata tretji in četrti pododstavek člena 4(2).
Placing on the market and use of articles produced before or on 10 July 2012 containing polychlorinated naphthalenes as a constituent of such articles shall be allowed until 10 January 2013.
Dajanje v promet in uporaba izdelkov, proizvedenih pred ali na 10. julij 2012, ki vsebujejo poliklorirane naftalene kot sestavni del takih izdelkov, se dovoli do 10. januarja 2013.
Placing on the market and use of articles already in use before or on 10 July 2012 containing polychlorinated naphthalenes as a constituent of such articles shall be allowed.
Dajanje v promet in uporaba izdelkov, v uporabi že pred ali na 10. julij 2012, ki vsebujejo poliklorirane naftalene kot sestavni del takih izdelkov, se dovoli.
Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs)
Klorirani alkani, C10–C13 (klorirani parafini s kratkimi verigami – SCCP)
By way of derogation, the production, placing on the market and use of substances or preparations containing SCCPs in concentrations lower than 1 % by weight shall be allowed.
Z odstopanjem se dovoli proizvodnja, dajanje v promet in uporaba snovi ali pripravkov, ki vsebujejo SCCP v koncentracijah, nižjih od 1 % mase.
By way of derogation, the production, placing on the market, and use of the following applications shall be allowed provided that Member States report to the Commission no later than 2015 and every four years thereafter on the progress made to eliminate SCCPs:
Z odstopanjem se dovoli proizvodnja, dajanje v promet in uporaba naslednjih rab pod pogojem, da države članice Komisiji poročajo najpozneje do leta 2015 in nato vsaka štiri leta o napredku za odpravo SCCP:
fire retardants in rubber used in conveyor belts in the mining industry;
zaščitna sredstva proti ognju za gumo, ki se uporablja v transportnih trakovih v rudarski industriji;
fire retardants in dam sealants.
zaščitna sredstva proti ognju za tesnilna sredstva pri jezovih.
Placing on the market and use of articles produced before or on 10 July 2012 containing SCCPs as a constituent of such articles shall be allowed until 10 January 2013.
Dajanje v promet in uporaba izdelkov, proizvedenih pred ali na 10. julij 2012, ki vsebujejo SCCP kot sestavni del takih izdelkov, se dovoli do 10. januarja 2013.
Placing on the market and use of articles already in use before or on 10 July 2012 containing SCCPs as a constituent of articles shall be allowed.
Dajanje v promet in uporaba izdelkov, proizvedenih pred ali na 10. julij 2012, ki vsebujejo SCCP kot sestavni del takih izdelkov, se dovoli.
As soon as new information on details of uses and safer alternative substances or technologies become available, the Commission shall review the derogations set out in point 2 so that the uses of SCCPs be phased out.
Kakor hitro so na voljo nove informacije o podrobnostih uporabe in varnejše nadomestne snovi ali tehnologije, Komisija ponovno oceni odstopanja iz točke 2, da se uporaba SCCP postopoma opusti.
Polychlorinated naphthalenes means chemical compounds based on the naphthalene ring system, where one or more hydrogen atoms have been replaced by chlorine atoms.’.
Poliklorirani naftaleni so kemijske spojine, ki temeljijo na sistemu obročev naftalena, kjer se eden ali več vodikovih atomov nadomesti z atomi klora.“
Commission Implementing Regulation (EU) No 520/2012
Izvedbena uredba Komisije (EU) št. 520/2012
on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council
o izvajanju dejavnosti na področju farmakovigilance, določenih v Uredbi (ES) št. 726/2004 Evropskega parlamenta in Sveta ter Direktivi 2001/83/ES Evropskega parlamenta in Sveta
Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [1], and in particular Article 87a thereof,
ob upoštevanju Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila [1] in zlasti člena 87a Uredbe,
Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [2], and in particular Article 108 thereof,
ob upoštevanju Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [2] in zlasti člena 108 Direktive,
Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products [3] strengthened and rationalised the monitoring of the safety of medicines that have been placed on the market in the Union.
Uredba (EU) št. 1235/2010 Evropskega parlamenta in Sveta z dne 15. decembra 2010 o spremembah Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila in Uredbe (ES) št. 1394/2007 o zdravilih za napredno zdravljenje [3], glede farmakovigilance zdravil za uporabo v humani medicini, je okrepila in racionalizirala spremljanje varnosti zdravil, ki so bila dana na trg v Uniji.
Similar provisions were introduced by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use [4] into Directive 2001/83/EC.
Podobne določbe so bile v Direktivo 2001/83/ES uvedene z Direktivo 2010/84/EU Evropskega parlamenta in Sveta z dne 15. decembra 2010 o spremembah Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini, glede farmakovigilance [4].
Pharmacovigilance activities cover the whole life-cycle management of medicinal products for human use in relation to safety.
Dejavnosti farmakovigilance zajemajo upravljanje celotnega življenjskega cikla zdravila za uporabo v humani medicini z vidika varnosti.
Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced the concept of the pharmacovigilance system master file.
Z Uredbo (EU) št. 1235/2010 in Direktivo 2010/84/EU je bil uveden pojem glavnega dosjeja o sistemu farmakovigilance.
In order to accurately reflect the pharmacovigilance system used by the marketing authorisation holder, the pharmacovigilance system master file should contain key information and documents covering all aspects of pharmacovigilance activities, including information on tasks that have been subcontracted.
Da bi glavni dosje o sistemu farmakovigilance točno odražal sistem farmakovigilance, ki ga uporablja imetnik dovoljenja za promet, bi moral vsebovati ključne informacije in dokumente, ki zajemajo vse vidike dejavnosti na področju farmakovigilance, vključno z informacijami o nalogah, oddanih v delo pogodbenikom.
It should contribute to the appropriate planning and conduct of audits by the marketing authorisation holder and the supervision of pharmacovigilance activities by the qualified person responsible for pharmacovigilance.
Prispevati bi moral k ustreznemu načrtovanju in izvajanju presoj s strani imetnika dovoljenja za promet in nadzoru dejavnosti, ki jih na področju farmakovigilance izvaja usposobljena oseba, odgovorna za farmakovigilanco.
At the same time it should enable national competent authorities to verify compliance concerning all aspects of the system.
Hkrati bi moral pristojnim nacionalnim organom omogočati, da preverijo skladnost vseh vidikov sistema.
The information contained in the pharmacovigilance system master file should be maintained so as to reflect any modifications that have been made and ensure easy accessibility and availability by national competent authorities for the purpose of inspections.
Informacije iz glavnega dosjeja o sistemu farmakovigilance bi bilo treba vzdrževati tako, da odražajo vse spremembe ter omogočajo, da so pristojnim nacionalnim organom za namene nadzora lahko dostopne in razpoložljive.
Quality systems should form an integral part of the pharmacovigilance system.
Sistemi kakovosti bi morali biti sestavni del sistema farmakovigilance.