natgillin/translations-raw huggingface dataset:
Since: (i) nuisance insects in the environment of the horse are not harmful to the rug itself; (ii) the concentration of permethrin in the rug is comparable to that in biocidal products and higher than the concentration used to control keratin feeding textile pests [3]; (iii) the mode of action of permethrin in the rug is identical to that of a biocidal product; and (iv) greater prominence and first importance is given in the product's information to the biocidal function of controlling insects than to other functions of the horse rug (in particular to mitigate cold weather conditions or UV-protection), the horse rug can be considered to have a primary biocidal function and to meet the definition of a biocidal product provided under Article 3(1)(a) of Regulation (EU) No 528/2012.
Ker (i) nadležne žuželke v okolju konja niso škodljive za samo odejo; (ii) je koncentracija permetrina v odeji primerljiva koncentraciji v biocidnih proizvodih in višja od tiste za zatiranje tekstilnih žuželk, ki se hranijo s keratinom [3]; (iii) je način delovanja permetrina v odeji identičen načinu delovanja biocidnega proizvoda; (iv) je večja prepoznavnost in prvi pomen dan v informaciji proizvoda o biocidni funkciji za zatiranje žuželk in ne o drugih funkcijah odeje za konje (zlasti za zmanjšanje neugodja pri hladnih vremenskih razmerah ali za zaščito pred UV sevanjem), se lahko šteje, da ima odeja za konje primarno biocidno funkcijo in da ustreza opredelitvi biocidnega proizvoda iz člena 3(1)(a) Uredbe (EU) št. 528/2012.
In accordance with Article 2(2) of Regulation (EU) No 528/2012 it is also important to consider whether the horse rug may fall within the scope of Directive 2001/82/EC of the European Parliament and of the Council [4] if it meets the definition of a veterinary medicinal product as provided under Article 1(2) of that Directive.
V skladu s členom 2(2) Uredbe (EU) št. 528/2012 je pomembno tudi ugotoviti, ali odeja za konje spada v področje uporabe Direktive 2001/82/ES Evropskega parlamenta in Sveta [4], če ustreza opredelitvi zdravila za uporabo v veterinarski medicini, kot je določeno v členu 1(2) navedene direktive.
When the horse rug is not designed to be applied as a topical insecticide and is not used with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis in horses, and when the horse rug is not presented either as having properties for treating or preventing any horse diseases but to control insects that may be present in the environment of the horse and may disturb the animal, the horse rug does not meet the definition of a veterinary medicinal product as provided under Article 1(2) of Directive 2001/82/EC and therefore falls under the scope of Regulation (EU) No 528/2012.
Kadar odeja za konje ni namenjena uporabi kot topični insekticid in se ne uporablja za ponovno vzpostavitev, izboljšanje ali spreminjanje fizioloških funkcij prek farmakološkega, imunološkega ali presnovnega delovanja ali za postavitev medicinske diagnoze pri konjih in kadar odeja za konje ni predstavljena, kot da ima lastnosti za zdravljenje ali preprečevanje bolezni konjev, temveč za zatiranje žuželk, ki so lahko prisotne v okolju konja in ga nadlegujejo, odeja za konje ne ustreza opredelitvi zdravila za uporabo v veterinarski medicini iz člena 1(2) Direktive 2001/82/ES in zato spada na področje uporabe Uredbe (EU) št. 528/2012.
Since product-type 18, as defined in Annex V to Regulation (EU) No 528/2012, covers products used for the control of arthropods (e.g. insects, arachnids and crustaceans), by means other than repulsion or attraction, the horse rug should be deemed to belong to product-type 18.
Ker vrsta proizvodov 18, kot je opredeljena v Prilogi V k Uredbi (EU) št. 528/2012, zajema proizvode, ki se uporabljajo za nadzor členonožcev (npr. žuželk, pajkov in rakov), vendar ne z njihovim odganjanjem ali privabljanjem, bi bilo treba šteti, da odeja za konje spada v vrsto proizvodov 18.
Furthermore, as permethrin is not under assessment nor approved [5] for use in biocidal products of product-type 19, the horse rug should not be claimed to have any repellent function.
Ker se permetrin ne ocenjuje in ni dovoljen [5] za uporabo v biocidnih proizvodih vrste proizvodov 19, se ne bi smelo šteti, da ima odeja za konje kakršno koli funkcijo repelenta.
A horse rug impregnated with permethrin for the purpose of controlling nuisance insects in the environment of the horse, by means other than repulsion or attraction, shall be considered as a biocidal product in accordance with Article 3(1)(a) of Regulation (EU) No 528/2012 and shall fall within product-type 18 as defined in Annex V to that Regulation.
Odeja za konje, impregnirana s permetrinom za zatiranje nadležnih žuželk v okolju konja, vendar ne z njihovim odganjanjem ali privabljanjem, se šteje za biocidni proizvod v skladu s členom 3(1)(a) Uredbe (EU) št. 528/2012 in spada v vrsto proizvodov 18, kot je opredeljena v Prilogi V k navedeni uredbi.
Done at Brussels, 8 June 2016.
V Bruslju, 8. junija 2016
Note for guidance on Frequently asked questions on treated articles (Question 11), available at https://circabc.europa.eu/w/browse/d7363efd-d8fb-43e6-8036-5bcc5e87bf22
Navodilo o pogosto zastavljenih vprašanjih o tretiranih izdelkih (vprašanje 11), na voljo na: https://circabc.europa.eu/w/browse/d7363efd-d8fb-43e6-8036-5bcc5e87bf22.
Assessment report of the evaluation of the active substance permethrin for product-type 18 (Section 2.1.2.1.
Poročilo o oceni aktivne snovi permetrin za uporabo v vrsti proizvodov 18 (oddelek 2.1.2.1 Predvideno področje uporabe/funkcija in organizmi, ki jih je treba zatirati), na voljo na: http://dissemination.echa.europa.eu/Biocides/ActiveSubstances/1342-18/1342-18_Assessment_Report.pdf.
Field of use envisaged/Function and organism(s) to be controlled), available at http://dissemination.echa.europa.eu/Biocides/ActiveSubstances/1342-18/1342-18_Assessment_Report.pdf
Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini (UL L 311, 28.11.2001, str. 1).
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
Izvedbena uredba Komisije (EU) št. 1090/2014 z dne 16. oktobra 2014 o odobritvi permetrina kot obstoječe aktivne snovi za uporabo v biocidnih proizvodih 8. in 18. vrste izdelkov (UL L 299, 17.10.2014, str. 10).
Commission Implementing Decision (EU) 2016/904
Izvedbeni sklep Komisije (EU) 2016/904
pursuant to Article 3(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council on propan-2-ol containing products used for hand disinfection
o proizvodih za razkuževanje rok, ki vsebujejo propan-2-ol, v skladu s členom 3(3) Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products [1], and in particular Article 3(3) thereof,
ob upoštevanju Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta z dne 22. maja 2012 o dostopnosti na trgu in uporabi biocidnih proizvodov [1] ter in zlasti člena 3(3) Uredbe,
In the context of an application under the Union authorisation procedure referred to in Article 41 of Regulation (EU) No 528/2012, on 3 December 2015 Germany requested the Commission to decide, pursuant to Article 3(3) of that Regulation, whether a group of ready to use propan-2-ol containing products (‘the products’) placed on the market to be used for hand disinfection, including in this instance surgical hand disinfection, and to be authorised as a biocidal product family as defined in Article 3(1)(s) of that Regulation, are biocidal products.
Na podlagi vloge za dovoljenje Unije iz člena 41 Uredbe (EU) št. 528/2012, predložene 3. decembra 2015, je Nemčija zaprosila Komisijo, da v skladu s členom 3(3) navedene uredbe odloči, ali so proizvodi, ki vsebujejo propan-2-ol in so pripravljeni za uporabo (v nadaljnjem besedilu: proizvodi) ter so bili dani na trg za uporabo kot razkužila za roke, vključno v tem primeru s kirurškim razkuževanjem rok, in ki naj bi bili dovoljeni kot družina biocidnih proizvodov, kot je opredeljena v členu 3(1)(s) navedene uredbe, biocidni proizvodi.
Germany considered that the products are medicinal products in accordance with Directive 2001/83/EC of the European Parliament and of the Council [2], arguing that the intended uses of the products show that they aim at preventing diseases in humans, as they can be used in areas and situations where disinfection is medically recommended.
Nemčija je menila, da so proizvodi zdravila v skladu z Direktivo 2001/83/ES Evropskega parlamenta in Sveta [2] z utemeljitvijo, da predvidene uporabe proizvodov kažejo, da je njihov cilj preprečevanje bolezni pri ljudeh, ker jih je mogoče uporabljati na področjih uporabe in v situacijah, na oz. v katerih je razkuževanje medicinsko priporočljivo.
According to Germany, this is particularly the case when the products are used by health professionals as a preoperative treatment procedure to prevent the risk of transmission of microorganisms into the surgical wound.
Po navedbah Nemčije to zlasti velja, kadar proizvode uporabljajo zdravstveni delavci pri postopku predoperativne priprave za preprečevanje tveganja prenosa mikroorganizmov v kirurško rano.
The products are intended to control a number of bacteria, viruses and fungi, which meet the definition of ‘harmful organism’ provided under Article 3(1)(g) of Regulation (EU) No 528/2012 since they may have a detrimental effect on humans.
Proizvodi so namenjeni nadzoru številnih bakterij, virusov in gliv, ki ustrezajo opredelitvi škodljivih organizmov iz člena 3(1)(g) Uredbe (EU) št. 528/2012, saj lahko imajo škodljiv vpliv na ljudi.
Since destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on any harmful organism is a biocidal function, the products meet the definition of a biocidal product provided under Article 3(1)(a) of that Regulation.
Ker je uničevanje, odvračanje, nevtralizacija, preprečevanje njihovega delovanja ali obvladovanje teh škodljivih organizmov na kateri koli drug način biocidna funkcija, proizvodi izpolnjujejo opredelitev biocidnega proizvoda iz člena 3(1)(a) navedene uredbe.
In accordance with Article 2(2) of Regulation (EU) No 528/2012 it is important to consider whether the products may fall within the scope of Directive 2001/83/EC if they meet the definition of a medicinal product as provided under Article 1(2) of that Directive.
V skladu s členom 2(2) Uredbe (EU) št. 528/2012 je pomembno ugotoviti, ali proizvodi spadajo v področje uporabe Direktive 2001/83/ES, če ustrezajo opredelitvi zdravila, kot je določeno v členu 1(2) navedene direktive.
Where the products are solely intended to reduce the micro-organism load on hands and the associated risk of transmitting micro-organisms from potentially contaminated hands and neither used to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, nor to make a medical diagnosis in humans, nor presented either as having properties to treat or to prevent any human diseases, the products do not meet the definition of a medicinal product as provided under Article 1(2) of Directive 2001/83/EC and therefore fall under the scope of Regulation (EU) No 528/2012.
Kadar so proizvodi namenjeni izključno za zmanjšanje števila mikroorganizmov na rokah in z njimi povezanega tveganja za prenos mikroorganizmov s potencialno onesnaženih rok in kadar se ne uporabljajo niti za ponovno vzpostavitev, izboljšanje ali spreminjanje fizioloških funkcij prek farmakološkega, imunološkega ali presnovnega delovanja niti za določitev medicinske diagnoze pri ljudeh ter kadar niso predstavljeni, kot da imajo lastnosti za zdravljenje ali preprečevanje bolezni ljudi, proizvodi ne ustrezajo opredelitvi zdravila iz člena 1(2) Direktive 2001/83/ES in zato spadajo na področje uporabe Uredbe (EU) št. 528/2012.
Since product-type 1, as defined in Annex V to Regulation (EU) No 528/2012, covers products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp, the products belong to product-type 1.
Ker vrsta proizvodov 1, kot je opredeljena v Prilogi V k Uredbi (EU) št. 528/2012, zajema proizvode, ki se uporabljajo za človekovo osebno higieno bodisi z nanosom na kožo ali lasišče bodisi s stikom z njima primarno za razkuževanje kože ali lasišča, ti proizvodi spadajo v vrsto proizvodov 1.
Propan-2-ol containing products to be used in hand disinfection, including in this instance surgical hand disinfection, for the purpose of reducing the risk of transmission of microorganisms shall be considered as biocidal products in accordance with Article 3(1)(a) of Regulation (EU) No 528/2012 and shall fall within product-type 1 as defined in Annex V to that Regulation.
Proizvodi, ki vsebujejo propan-2-ol in se uporabljajo za razkuževanje rok, vključno v tem primeru s kirurškim razkuževanjem rok, za zmanjšanje tveganja prenosa mikroorganizmov, se štejejo za biocidne proizvode v skladu s členom 3(1)(a) Uredbe (EU) št. 528/2012 in spadajo v vrsto proizvodov 1, kot je opredeljena v Prilogi V k navedeni uredbi.
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 (OJ L 311, 28.11.2001, p. 67).
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, 28.11.2001, str. 67).
Council Decision (EU) 2016/915
Sklep Sveta (EU) 2016/915
on the position to be taken on behalf of the European Union with regard to the international instrument to be drawn up within the ICAO bodies and intended to lead to the implementation from 2020 of a single global market-based measure for international aviation emissions
o stališču, ki se zavzame v imenu Evropske unije v zvezi z mednarodnim instrumentom, ki se pripravi v okviru organov ICAO in naj bi omogočil izvajanje enotnega globalnega tržnega ukrepa od leta 2020 za emisije iz mednarodnega letalstva
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1), in conjunction with Article 218(9), thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 192(1) v povezavi s členom 218(9) Pogodbe,
Greenhouse gas emissions from international aviation represent more than 2 % of global emissions and are growing exponentially, with projections for 2050 indicating that, under a ‘business as usual’ scenario, such emissions from international aviation activities could grow above 200 % compared to current levels.
Emisije toplogrednih plinov iz mednarodnega letalstva predstavljajo več kot 2 % svetovnih emisij in ta odstotek se skokovito povečuje, tako da se za leto 2050 napoveduje, da bi se lahko po običajnem scenariju take emisije iz mednarodnih letalskih dejavnosti povečale za več kot 200 % v primerjavi s sedanjimi ravnmi.
All sectors of the economy should contribute to achieving those emission reductions, including international aviation.
Unija in njene države članice so pogodbenice Kjotskega protokola iz leta 1997, ki od njih zahteva, da si v okviru ICAO prizadevajo za omejevanje emisij toplogrednih plinov iz mednarodnega letalstva.
The International Civil Aviation Organisation (ICAO) was established by the 1944 Chicago Convention on International Civil Aviation.
Na 33. zasedanju skupščine ICAO (2001) je bil potrjen razvoj odprtega sistema za trgovanje z emisijami v mednarodnem letalstvu [2].
The Member States of the Union are Contracting Parties to that Convention and members of the ICAO, while the Union has observer status in certain ICAO meetings, including the triennial ICAO Assembly.
Odbor ICAO za varstvo okolja v letalstvu je leta 2004 priporočil prenehanje izvajanja sistema trgovanja z emisijami iz letalstva, ki temelji na novem pravnem instrumentu pod okriljem ICAO.
The Union and its Member States are Parties to the 1997 Kyoto Protocol, which requires them to pursue the limitation of emissions of greenhouse gases from international aviation through the ICAO.
Na 35. zasedanju skupščine ICAO (2004) sta bila podprta nadaljnji razvoj sistema za odprto trgovanje z emisijami in možnost za države pogodbenice ICAO, da emisije iz mednarodnega letalstva vključijo v svoje sisteme trgovanja z emisijami [3], vendar pa je bilo na 36. zasedanju skupščine ICAO (2007) pozvano, da bi bili letalski operaterji iz drugih držav pogodbenic ICAO izvzeti, razen če med temi državami ne obstaja vzajemni dogovor o izvajanju sistema za trgovanje z emisijami za letalske operaterje iz drugih držav pogodbenic ICAO [4].
Decision 1600/2002/EC of the European Parliament and of the Council [1] called for the Union to identify and undertake specific actions to reduce greenhouse gas emissions from international aviation if no such action were agreed within the ICAO by 2002.
Unija, njene države članice in druge evropske države si dosledno pridržujejo pravico, da na nediskriminatorni osnovi uporabljajo tržne ukrepe za vse letalske operatorje, ki zagotavljajo storitve v, iz ali znotraj njihovega ozemlja, pri čemer opozarjajo, da Čikaška konvencija priznava pravice svojih pogodbenic, da na nediskriminatorni osnovi uporabljajo lastne zakone in predpise s področja letalstva za zrakoplove vseh držav, ki zagotavljajo storitve v, iz ali znotraj njihovega ozemlja [5],.
The 33rd Session of the ICAO Assembly (2001) endorsed the development of an open emissions trading system for international aviation [2].
Glede na to, da je omejitev emisij toplogrednih plinov iz mednarodnega letalstva ključni prispevek v skladu s splošnimi zavezami glede zmanjšanja emisij, sta Evropski parlament in Svet sprejela Direktivo 2008/101/ES [6], ki je spremenila Direktivo 2003/87/ES [7].
The ICAO Committee on Aviation Environmental Protection recommended in 2004 that an aviation-specific emissions trading system based on a new legal instrument under ICAO auspices should not be pursued further.
V peti uvodni izjavi Direktive 2008/101/ES je določeno, da bo Unija skušati zagotoviti, da tak globalen sporazum za omejitev dviga globalne temperature vključuje ukrepe za znižanje emisij toplogrednih plinov iz letalstva ter da bi morala Komisija v tem primeru preučiti, katere spremembe Direktive 2003/87/ES, kakor se nanaša na letalske operaterje, so potrebne.
The 35th Session of the ICAO Assembly (2004) endorsed the further development of an open emissions trading system and the possibility for ICAO Contracting States to incorporate emissions from international aviation into their emissions trading schemes [3], but the 36th Session of the ICAO Assembly (2007) called for aircraft operators based in other ICAO Contracting States to be exempt unless it were mutually agreed between those States to implement an emissions trading system on other ICAO Contracting State's aircraft operators [4].
Na 38. zasedanju skupščine ICAO (2013) je bilo odločeno, da si ICAO in njene države pogodbenice z ustreznimi okoljskimi ali letalskimi organizacijami v vsaki državi pogodbenici ICAO skupaj prizadevajo za izpolnitev skupnega srednjeročnega globalnega okvirnega cilja, da se globalne neto emisije ogljika iz mednarodnega letalstva od leta 2020 ohranijo na isti ravni, odločeno pa je bilo tudi, da se razvije globalni tržni ukrep za emisije iz mednarodnega letalstva ter da se o rezultatih njihovega dela za sprejetje sklepa poroča na 39. zasedanju skupščine ICAO (2016).
The Union, its Member States and other European States have consistently reserved the right to apply market-based measures (MBMs) on a non-discriminatory basis to all aircraft operators providing services to, from or within their territory, recalling that the Chicago Convention recognises its Parties' rights to apply, on a non-discriminatory basis, their own aviation laws and regulations to the aircrafts of all States [5] providing services to, from or within their territory.
Da bi se olajšal napredek na zasedanju skupščine ICAO leta 2016 pri pripravi ustreznega mednarodnega instrumenta, sta se Evropski parlament in Svet odločila, da se na podlagi Uredbe (EU) št. 421/2014 [9] zahteve Direktive 2003/87/ES v zvezi z leti na letališča v državah zunaj Evropskega gospodarskega prostora (EGP) in z njih začasno štejejo za izpolnjene.
The fifth recital of Directive 2008/101/EC provides that the Union will seek to ensure that such a global agreement intended to contain global temperature increase includes measures to reduce greenhouse gas emissions from aviation and, in this event, the Commission ought to consider which amendments to Directive 2003/87/EC, as it applies to aircraft operators, are necessary.
Direktiva 2003/87/ES, kakor je bila spremenjena z Uredbo (EU) št. 421/2014, določa nekatere obveznosti, ki so bile naložene Komisiji po 39. zasedanju skupščine ICAO (2016).
The next meeting of the ICAO Assembly will take place in 2016, and ought to agree on an international instrument intended to lead to the implementation from 2020 of a single global MBM for international aviation emissions.
Komisija v svojem poročilu preuči ustrezno področje uporabe za zajetje emisij iz dejavnosti na letališča v državah zunaj EGP in z njih od 1. januarja 2017 dalje in po potrebi vanj vključi predloge v odziv na navedeni razvoj.
The 38th Session of the ICAO Assembly (2013) resolved that ICAO and its Contracting States, with relevant environmental or aviation organisations in each ICAO Contracting State, would work together to strive to achieve a collective medium-term global aspirational goal of keeping the global net carbon emissions from international aviation from 2020 at the same level and decided to develop a global MBM for international aviation emissions and to report the results of its work for decision at the 39th Session of the ICAO Assembly (2016).
Ustrezno je določiti stališče, ki se zavzame v imenu Unije v zvezi z mednarodnim instrumentom, ki se pripravi v okviru organov ICAO in naj bi omogočil izvajanje enotnega globalnega tržnega ukrepa od leta 2020 za emisije iz mednarodnega letalstva.
International aviation emissions are projected to be around 70 % higher in 2020 than in 2005 [8] and the Union and its Member States have consistently advocated that the global reduction target for greenhouse gas emissions from international aviation should be a 10 % reduction by 2020 compared to 2005 levels.
Unija sicer ni članica ICAO, ima pa status opazovalke, ki bi lahko omogočil Komisiji udeležbov v nekaterih razpravah v zadevnih organih ICAO, vključno s skupščino, za podporo stališča Unije.
However, it appears expedient for the Union to seize the opportunity to promote the development, within a rather short time frame, of a global MBM to limit greenhouse gas emissions from international aviation no higher than their 2020 levels, bearing in mind the review of the objective over time, as appropriate.
Stališče Unije je treba sprejeti že veliko pred naslednjim zasedanjem skupščine ICAO –
In order to facilitate progress at the 2016 ICAO Assembly towards an appropriate international instrument, the European Parliament and the Council decided, by virtue of Regulation (EU) No 421/2014 [9], to consider on a temporary basis the requirements of Directive 2003/87/EC to be satisfied in respect of flights to and from aerodromes located in countries outside the European Economic Area (EEA).
SPREJEL NASLEDNJI SKLEP:
In doing so, the Union emphasised that legal requirements can be applied in respect of flights to and from aerodromes located in EEA States, in the same manner as legal requirements can be applied in respect of the emissions from flights between such aerodromes.
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