natgillin/translations-raw huggingface dataset:
The tube is intended to be used by medical professionals to insert a ‘stent’ into the human body.
Namenjena je uporabi v medicini za vstavljanje žilne opornice „stenta“ v človeško telo.
The tube is not left in the body after use.
Po uporabi se odstrani iz telesa.
Classification is determined by General Rules 1 and 6 for the interpretation of the Combined Nomenclature, Note 8 to Chapter 39 and by the wording of CN codes 3917 and 39173900.
Uvrstitev opredeljujejo splošni pravili 1 in 6 za razlago kombinirane nomenklature, opomba 8 k poglavju 39 ter besedilo oznak KN 3917 in 39173900.
Given its objective characteristics and properties, the goods meet the terms of heading 3917 and fulfil the requirements of Note 8 to Chapter 39.
Glede na svoje objektivne značilnosti in lastnosti proizvod izpolnjuje pogoje za tarifno številko 3917 in zahteve iz opombe 8 k poglavju 39.
The intended use of the tube is not inherent to its objective characteristics as, upon presentation, the tube cannot be identified as an instrument or appliance used in medical sciences.
Predvidena uporaba cevke ne izhaja iz njenih objektivnih lastnosti, saj je ob predložitvi ni mogoče identificirati kot instrument ali pripomoček, ki se uporablja v medicini.
Consequently, classification under heading 9018 is excluded.
Uvrstitev pod tarifno številko 9018 je zato izključena.
It is therefore to be classified under CN code 39173900 as other tubes of plastics.
Izdelek se zato uvrsti pod oznako KN 39173900 kot druge plastične cevi.
Commission Regulation (EU) No 280/2013
Uredba Komisije (EU) št. 280/2013
Having regard to Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community [1], and in particular Article 6(1) thereof,
ob upoštevanju Direktive 2008/57/ES Evropskega parlamenta in Sveta z dne 17. junija 2008 o interoperabilnosti železniškega sistema v Skupnosti [1] in, zlasti člena 6(1) Direktive,
Article 4b of Commission Regulation (EC) No 62/2006 of 23 December 2005 concerning the technical specification for interoperability relating to the telematic applications for freight subsystem of the trans-European conventional rail system [2] provides that the European Railway Agency has to update the documents referred to in Annex A to Regulation (EC) No 62/2006 on the basis of change requests that are validated before 13 May 2012.
Člen 4b Uredbe Komisije (ES) št. 62/2006 z dne 23. decembra 2005 o tehnični specifikaciji za interoperabilnost v zvezi s telematskimi aplikacijami za tovorni podsistem vseevropskega železniškega sistema za konvencionalne hitrosti [2] določa, da Evropska agencija za železniški promet posodablja dokumente iz Priloge A k Uredbi (ES) št. 62/2006 na podlagi zahtev za spremembe, potrjenih pred 13. majem 2012.
The Commission has received European Railway Agency recommendation ERA/REC/06a-2012/INT of 24 July 2012 to update Annex A to Regulation (EC) No 62/2006 in order to refer to the technical documents which have been amended in accordance with the change management process (‘Final Baseline 5.2’).
Komisija je prejela priporočilo Evropske agencije za železniški promet ERA/REC/06a-2012/INT z dne 24. julija 2012 za posodobitev Priloge A k Uredbi (ES) št. 62/2006, da bi se sklicevala na tehnične dokumente, ki so bili spremenjeni v skladu s postopkom upravljanja sprememb („končna različica 5.2“).
Regulation (EC) No 62/2006 should therefore be amended accordingly.
Uredbo (ES) št. 62/2006 bi bilo zato treba ustrezno spremeniti.
Annex A to Regulation (EC) No 62/2006 is replaced by the text set out in the Annex to this Regulation.
Priloga A k Uredbi (ES) št. 62/2006 se nadomesti z besedilom iz Priloge k tej uredbi.
TAF TSI — ANNEX A.5:
TAF TSI – PRILOGA A.5:
Figures and Sequence Diagrams of the TAF TSI Messages
številke in diagrami zaporedja v sporočilih TAF TSI
TAF TSI — ANNEX D.2:
TAF TSI – PRILOGA D.2:
APPENDIX A (WAGON/ILU TRIP PLANNING)
DODATEK A (NAČRTOVANJE POTOVANJA VAGONA/ILU)
APPENDIX B — WAGON AND INTERMODAL UNIT OPERATING DATABASE (WIMO)
DODATEK B – OPERATIVNA PODATKOVNA BAZA ZA VAGONE IN INTERMODALNE ENOTE (WIMO)
APPENDIX C — REFERENCE FILES
DODATEK C – REFERENČNE DATOTEKE
APPENDIX D — INFRASTRUCTURE RESTRICTION NOTICE DATA
DODATEK D – PODATKI O OMEJITVAH INFRASTRUKTURE
APPENDIX E — COMMON INTERFACE
DODATEK E – SKUPNI VMESNIK
APPENDIX F — TAF TSI DATA AND MESSAGE MODEL
DODATEK F – VZOREC PODATKOV IN SPOROČIL TAF TSI
Commission Implementing Regulation (EU) No 281/2013
Izvedbena uredba Komisije (EU) št. 281/2013
Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) [1] and in particular Article 64(2) and Article 186, in conjunction with Article 4 thereof,
ob upoštevanju Uredbe Sveta (ES) št. 1234/2007 z dne 22. oktobra 2007 o vzpostavitvi skupne ureditve kmetijskih trgov in o posebnih določbah za nekatere kmetijske proizvode („Uredba o enotni SUT“) [1] ter zlasti člena 64(2) in člena 186 v povezavi s členom 4 Uredbe,
The reduced surplus levy should be paid after the application is admitted and before the certificate is issued.
Znižano presežno dajatev bi bilo treba plačati po tem, ko je vloga sprejeta, in preden je izdano dovoljenje.
It is therefore necessary to set the date of establishment of the amounts in question within the meaning of Articles 2(2) and Article 6(3)(a) of Council Regulation (EC, Euratom) No 1150/2000 of 22 May 2000 implementing Decision 2007/436/EC, Euratom on the system of the European Communities own resources [5].
Zato je treba določiti datum določitve zadevnih zneskov ob upoštevanju člena 2(2) in člena 6(3)(a) Uredbe Sveta (ES, Euratom) št. 1150/2000 z dne 22. maja 2000 o izvajanju Sklepa 2007/436/ES, Euratom o sistemu virov lastnih sredstev Evropskih skupnosti [5].
By way of derogation from Article 3(1) of Regulation (EC) No 967/2006, the amount of the surplus levy for a maximum quantity of 150000 tonnes of sugar in white sugar equivalent and 8000 tonnes of isoglucose in dry matter, produced in excess of the quota fixed in Annex VI to Regulation (EC) No 1234/2007 and released on the Union market in the 2012/2013 marketing year, shall be fixed at EUR 172 per tonne.
Z odstopanjem od člena 3(1) Uredbe (ES) št. 967/2006 se znesek presežne dajatve za največjo dovoljeno količino 150000 ton sladkorja, izraženo v ekvivalentu belega sladkorja, in 8000 ton izoglukoze, izraženo v suhi snovi, ki sta bila proizvedena nad kvoto iz Priloge VI k Uredbi (ES) št. 1234/2007 in dana na trg Unije v tržnem letu 2012/2013, določi na 172 EUR na tono.
The reduced surplus levy provided for in paragraph 1 shall be paid after the application referred to in Article 2 is admitted and before the certificate referred to in Article 6 is issued.
Znižana presežna dajatev iz odstavka 1 se plača po tem, ko je sprejeta vloga iz člena 2, in preden je izdano dovoljenje iz člena 6.
The period during which applications may be submitted shall end on 3 April 2013 at 12 noon, Brussels time.
Obdobje za predložitev vlog se konča 3. aprila 2013 ob 12:00 po bruseljskem času.
Each tonne covered by a certificate but not released on the Union market for reasons other than force majeure, shall be subject to payment of an amount of EUR 328/tonne.
Za vsako tono iz dovoljenja, ki ni bila dana na trg Unije iz drugih razlogov, kot je višja sila, se plača znesek v višini 328 EUR na tono.
For the 2012/2013 marketing year, the levy referred to in Article 3 of Regulation (EC) No 967/2006 shall not apply to the quantities issued of this certificate, subject to the respect of the rules laid down in Implementing Regulation (EU) No 281/2013, in particular in Article 2(5)(c).
Za tržno leto 2012/2013 se dajatev iz člena 3 Uredbe (ES) št. 967/2006 ne uporablja za količine, odobrene s tem dovoljenjem, pod pogojem, da se upoštevajo pravila iz Izvedbene uredbe Komisije (EU) št. 281/2013, zlasti člena 2(5)(c).
Commission Implementing Regulation (EU) No 282/2013
Izvedbena uredba Komisije (EU) št. 282/2013
Commission Regulation (EU) No 283/2013
Uredba Komisije (EU) št. 283/2013
setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
o določitvi zahtevanih podatkov o aktivnih snoveh v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC [1], and in particular Article 78(1)(b) thereof,
ob upoštevanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS [1], ter zlasti člena 78(1)(b) Uredbe,
In accordance with Article 8(4) of Regulation (EC) No 1107/2009, Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances [2] was adopted.
V skladu s členom 8(4) Uredbe (ES) št. 1107/2009 je bila sprejeta Uredba Komisije (EU) št. 544/2011 z dne 10. junija 2011 o izvajanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta glede zahtevanih podatkov o aktivnih snoveh [2].
It contains the requirements for the dossiers to be submitted for the approval of active substances, as set out in Annex II to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [3].
V njej so navedene zahteve glede dokumentacije, ki jo je treba predložiti za odobritev aktivnih snovi v skladu s Prilogo II k Direktivi Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet [3].
It is necessary to modify the data requirements concerning chemical substances in order to take into account current scientific and technical knowledge.
Spremeniti bi bilo treba zahteve glede podatkov o kemijskih snoveh, da se upošteva sedanje znanstveno in tehnično znanje.
More detailed information for the implementation of the data requirements is laid down in relevant guidance documents.
Podrobnejše informacije o izvajanju zahtev glede podatkov so navedene v ustreznih smernicah.
Regulation (EU) No 544/2011 should therefore be repealed.
Uredbo (EU) št. 544/2011 bi bilo zato treba razveljaviti.
A reasonable period should be allowed to elapse before the modified data requirements become applicable in order to permit applicants to prepare themselves to meet those requirements.
Pred začetkom veljavnosti spremenjenih zahtev glede podatkov bi bilo treba zagotoviti ustrezno obdobje, da se bodo lahko vlagatelji pripravili na izpolnjevanje navedenih zahtev.
In order to permit Member States and the interested parties to prepare themselves to meet the new requirements, it is appropriate to lay down transitional measures concerning data submitted for applications for the approval, renewal of approval or amendment to the conditions of approval of active substances and data submitted for applications for authorisation, renewal of authorisation and amendment to the authorisation of plant protection products.
Da se bodo lahko države članice in zainteresirane strani pripravile na izpolnjevanje novih zahtev, je primerno določiti prehodne ukrepe glede podatkov, ki jih je treba predložiti za vloge za odobritev, podaljšanje odobritve ali spremembo pogojev za odobritev aktivnih snovi, ter podatkov, ki jih je treba predložiti za vloge za registracijo, podaljšanje registracije in spremembo registracije fitofarmacevtskih sredstev.
These transitional measures are without prejudice to Article 80 of Regulation (EC) No 1107/2009.
Ti prehodni ukrepi ne posegajo v člen 80 Uredbe (ES) št. 1107/2009.
Data requirements for active substances
Zahtevani podatki o aktivnih snoveh
The data requirements for the active substance provided for in Article 8(1)(b) of Regulation (EC) No 1107/2009 shall be as set out in the Annex to this Regulation.
V Prilogi k tej uredbi se določijo zahtevani podatki o aktivni snovi, kakor so določeni v členu 8(1)(b) Uredbe (ES) št. 1107/2009.
Regulation (EU) No 544/2011 is repealed.
Uredba (EU) št. 544/2011 se razveljavi.
References to the repealed Regulation shall be construed as references to this Regulation
Sklicevanja na razveljavljeno uredbo se štejejo za sklicevanja na to uredbo.
Transitional measures as regards procedures concerning active substances
Prehodni ukrepi glede postopkov v zvezi z aktivnimi snovmi
With respect to active substances, Regulation (EU) No 544/2011 shall continue to apply as regards the following:
Uredba (EU) št. 544/2011 se v zvezi z aktivnimi snovmi še naprej uporablja na področju za:
procedures concerning the approval of an active substance or an amendment to the approval of such a substance pursuant to Article 13 of Regulation (EC) No 1107/2009 for which the dossiers provided for in Article 8(1) and (2) thereof have been submitted by 31 December 2013;
postopke za odobritev aktivne snovi ali spremembo odobritve takšne snovi v skladu s členom 13 Uredbe (ES) št. 1107/2009, za katero je dokumentacija iz člena 8(1) in (2) navedene uredbe predložena do 31. decembra 2013;
procedures concerning the renewal of approval of an active substance pursuant to Article 20 of Regulation (EC) No 1107/2009 for which the supplementary dossiers referred to in Article 9 of Commission Regulation (EU) No 1141/2010 [4] have been submitted by 31 December 2013.
postopke za podaljšanje odobritve aktivne snovi v skladu s členom 20 Uredbe (ES) št. 1107/2009, za katere je dopolnilna dokumentacija iz člena 9 Uredbe Komisije (EU) št. 1141/2010 [4] predložena do 31. decembra 2013.
Transitional measures as regards procedures concerning plant protection products
Prehodni ukrepi glede postopkov v zvezi s fitofarmacevtskimi sredstvi
Regulation (EU) No 544/2011 shall continue to apply as regards procedures concerning the authorisation of a plant protection product, as referred to in Article 28 of Regulation (EC) No 1107/2009, provided that the respective application has been submitted by 31 December 2015 and that the plant protection product contains at least one active substance for which the dossiers or supplementary dossiers have been submitted in compliance with Article 3.
Uredba (EU) št. 544/2011 se še naprej uporablja za postopke za registracijo fitofarmacevtskega sredstva iz člena 28 Uredbe (ES) št. 1107/2009, če je zadevna vloga predložena do 31. decembra 2015, fitofarmacevtsko sredstvo pa vsebuje vsaj eno aktivno snov, za katero je bila v skladu s členom 3 predložena dokumentacija ali dopolnilna dokumentacija.
By way of derogation from paragraph 1, from 1 January 2014 applicants may choose to apply the data requirements, as set out in the Annex to this Regulation.
Vlagatelji se lahko z odstopanjem od odstavka 1 od 1. januarja 2014 odločijo za uporabo zahtevanih podatkov iz Priloge k tej uredbi.
This choice shall be made in writing when submitting the application and shall be irrevocable.
Ta odločitev se pisno navede ob predložitvi vloge in je nepreklicna.
For procedures concerning the renewal of approval of active substances whose approval expires on 1 January 2016 or later, this Regulation shall apply as of entry into force.
Za postopke za podaljšanje odobritve aktivnih snovi, katerih odobritev poteče 1. januarja 2016 ali pozneje, se ta uredba uporablja od začetka veljavnosti.
As regards all other procedures, it shall apply from 1 January 2014.
Za vse druge postopke se uporablja od 1. januarja 2014.
OJ L 155, 11.6.2011, p. 1.
UL L 155, 11.6.2011, str. 1.
Information to be submitted, its generation and its presentation
Informacije, ki jih je treba predložiti, njihovo pridobivanje in predstavitev
The information submitted shall meet the following requirements.
Predložene informacije izpolnjujejo naslednje zahteve.
The information shall be sufficient to evaluate the foreseeable risks, whether immediate or delayed, which the active substance may entail for humans, including vulnerable groups, animals and the environment and contain at least the information and results of the studies referred to in this Annex.
Informacije zadostujejo za oceno predvidljivih tveganj, bodisi takojšnjih ali zapoznelih, ki jih aktivna snov lahko pomeni za ljudi, vključno z ranljivimi skupinami, živali in okolje, in vsebujejo vsaj informacije in rezultate študij iz te priloge.
Any information on potentially harmful effects of the active substance, its metabolites and impurities on human and animal health or on groundwater shall be included.
Vključijo se vse informacije o možnih škodljivih učinkih aktivne snovi, njenih metabolitov in nečistoč na zdravje ljudi in živali ali podtalnico.
Any information on potentially unacceptable effects of the active substance, its metabolites and impurities on the environment, on plants and plant products shall be included.
Vključijo se vse informacije o možnih nesprejemljivih učinkih aktivne snovi, njenih metabolitov in nečistoč na okolje, rastline in rastlinske proizvode.
The information shall include all relevant data from the scientific peer reviewed open literature on the active substance, metabolites and breakdown or reaction products and plant protection products containing the active substance and dealing with side-effects on health, the environment and non-target species.
Informacije vključujejo vse ustrezne podatke iz strokovno pregledane javno dostopne znanstvene literature o aktivni snovi, metabolitih, razgradnih ali reakcijskih produktih in fitofarmacevtskih sredstvih, ki vsebujejo aktivno snov, in podatke, ki obravnavajo stranske učinke na zdravje, okolje in neciljne vrste.
A summary of this data shall be provided.
Zagotovi se povzetek teh podatkov.
The information shall include a full and unbiased report of the studies conducted as well as a full description of them.
Informacije vključujejo popolno in nepristransko poročilo o izvedenih študijah ter popoln opis teh študij.
Such information shall not be required, where one of the following conditions is fulfilled:
Te informacije niso potrebne, če je izpolnjen eden od naslednjih pogojev:
it is not necessary owing to the nature of the product or its proposed uses, or it is not scientifically necessary;
niso potrebne zaradi narave ali predlaganih načinov uporabe proizvoda ali pa niso znanstveno potrebne;
it is technically not possible to supply.
tehnično jih ni mogoče zagotoviti.
In such a case a justification shall be provided.
V takem primeru se predloži utemeljitev.
The simultaneous use of the active substance as a biocide or in veterinary medicine shall be reported.
Navede se sočasna uporaba aktivne snovi kot biocida ali v zdravilu za uporabo v veterinarski medicini.
If the applicant for the active substance in the plant protection product is identical to the one responsible for the notification of the active substance as a biocide or as a veterinary medicine, a summary of all relevant data submitted for approval of the biocide or the veterinary medicine, shall be submitted.
Če je vlagatelj za aktivno snov v fitofarmacevtskem sredstvu hkrati vlagatelj, odgovoren za uradno obvestilo o aktivni snovi, ki se uporablja kot biocid ali zdravilo za uporabo v veterinarski medicini, se predloži povzetek vseh ustreznih podatkov, predloženih za odobritev biocida ali zdravila za uporabo v veterinarski medicini.
This summary shall include toxicological reference values and MRL proposals, taking into account any possible cumulative exposure due to different uses of the same substance based on scientific methods accepted by the European competent authorities, together with a summary of the residues and toxicology data and information on the use of the product.
Ta povzetek vključuje toksikološke referenčne vrednosti in predloge za MRL ob upoštevanju kakršne koli možne kumulativne izpostavljenosti zaradi različnih načinov uporabe iste snovi na podlagi znanstvenih metod, ki so jih sprejeli evropski pristojni organi, skupaj s povzetkom podatkov o ostankih in toksikoloških podatkov ter informacij o uporabi proizvoda.
If the applicant for the active substance in the plant protection product is not identical to the one responsible for the notification of the active substance as a biocide or in veterinary medicine, a summary of all available data shall be submitted.
Če vlagatelj za aktivno snov v fitofarmacevtskem sredstvu ni hkrati vlagatelj, odgovoren za uradno obvestilo o aktivni snovi, ki se uporablja kot biocid ali v zdravilu za uporabo v veterinarski medicini, se predloži povzetek vseh podatkov, ki so na voljo.
Where relevant, the information shall be generated using test methods, which are included in the list referred to in point 6.
Kadar je ustrezno, se informacije pridobijo s preskusnimi metodami, navedenimi na seznamu iz točke 6.
In the absence of suitable internationally or nationally validated test guidelines, test guidelines accepted by the European competent authority shall be used.
Če niso na voljo ustrezne mednarodno ali nacionalno potrjene smernice za preskušanje, se uporabijo smernice za preskušanje, ki jih je sprejel evropski pristojni organ.
Any deviations shall be described and justified.
Vsa odstopanja se navedejo in utemeljijo.
The information shall include a full description of the test methods used.
Informacije vključujejo popoln opis uporabljenih preskusnih metod.
The information shall include a list of endpoints for the active substance.
Informacije vključujejo seznam končnih točk za aktivno snov.
Where relevant, the information shall be generated in accordance with Directive 2010/63/EU of the European Parliament and of the Council [1].
Kadar je ustrezno, se informacije pridobijo v skladu z Direktivo 2010/63/EU Evropskega parlamenta in Sveta [1].
The information on the active substance, taken together with the information concerning one or more plant protection products containing the active substance and together, if appropriate, with the information concerning safeners and synergists and other components of the plant protection product, shall be sufficient to:
Informacije o aktivni snovi skupaj z informacijami o enem ali več fitofarmacevtskih sredstvih, ki vsebujejo aktivno snov, in po potrebi skupaj z informacijami o varovalih in sinergistih ter drugih sestavinah fitofarmacevtskega sredstva, zadoščajo za:
permit an assessment of the risks for humans, associated with handling and use of plant protection products containing the active substance;
oceno tveganj za ljudi, povezane z uporabo fitofarmacevtskih sredstev, ki vsebujejo aktivno snov, in ravnanjem z njimi;
permit an assessment of the risks for human and animal health, arising from residues of the active substance and its metabolites, impurities, breakdown and reaction products remaining in water, air, food and feed;
oceno tveganj za zdravje ljudi in živali zaradi ostankov aktivne snovi in njenih metabolitov, nečistoč, razgradnih in reakcijskih produktov v vodi, zraku, hrani in krmi;
predict the distribution, fate and behaviour in the environment of the active substance and metabolites, breakdown and reaction products, where they are of toxicological or environmental significance, as well as the time courses involved;
predvidevanje porazdelitve, končnega stanja in obnašanja aktivne snovi, metabolitov, razgradnih in reakcijskih produktov v okolju, kadar so toksikološko ali okoljsko pomembni, ter tudi časovnih potekov v teh procesih;
permit an assessment of the impact on non-target species (flora and fauna), including the impact on their behaviour, which are likely to be exposed to the active substance, its metabolites, breakdown and reaction products, where they are of toxicological or environmental significance.
oceno učinka na neciljne vrste (rastlinske in živalske vrste), vključno z učinkom na njihovo vedenje, ki so lahko izpostavljene aktivni snovi, njenim metabolitom, razgradnim in reakcijskim produktom, če so toksikološko ali okoljsko pomembni.