natgillin/translations-raw huggingface dataset:
ruminant liver 0,1 [2]others products of animal origin 0,01 [1] [2]
jetra prežvekovalcev 0,1 [2]drugi izdelki živalskega izvora 0,01 [1] [2]
Mesotrione (Sum of mesotrione and MNBA (4-methylsulfonyl-2-nitro benzoic acid), expressed as mesotrione)
Mezotrion (vsota mezotriona in MNBA (4-metilsulfonil-2-nitro benzojska kislina), izražena kot mezotrion)
Flufenacet (Sum of all compounds containing the N fluorophenyl-N-isopropyl moiety expressed as flufenacet)
Flufenacet (vsota vseh sestavin, ki vsebujejo delež N fluorofenil-N-izopropila, izraženega kot ekvivalent flufenaceta)
Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts
Sadje, sveže, posušeno ali nekuhano, konzervirano z zamrzovanjem, ki ne vsebuje dodanega sladkorja; oreški
Pomelos
Pomela
Cashew nuts
Indijski orehi
Olives
Oljke
Lettuce & similar
Solata in podobno
Spinach & similar
Špinača in podobno
Oil seed
Oljnice
Peanuts
Zemeljski oreški ali arašidi
Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)
Čaj (lističi in stebelca - sušeni, fermentirani ali drugače - iz lističev Camellie sinensis)
Passion-fruit
Pasijonka
With respect to the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, the related technical and scientific evaluations were finalised in the form of Commission review reports.
Glede na vključitev zadevnih aktivnih snovi v Prilogo I k Direktivi 91/414/EGS so bile dokončane s tem povezane tehnične in znanstvene ocene v obliki poročil Komisije o pregledu.
The assessment reports for those substances mentioned were finalised on the dates as mentioned in the Commission Directives cited in Recitals 1 and 2.
Poročila o oceni za navedene snovi so bila dokončana na datume, ki so navedeni v direktivah Komisije iz uvodnih izjav 1 in 2.
These reports fixed the Acceptable Daily Intake (ADI) and if necessary, the Acute Reference Dose (ARfD) for the substances concerned.
V teh poročilih je določen sprejemljiv dnevni vnos (SDV) in po potrebi akutni referenčni odmerek za zadevne snovi.
The exposure of consumers of food products treated with the active substance concerned has been assessed and evaluated in accordance with Community procedures.
Izpostavljenost potrošnikov živilskih proizvodov, tretiranih z zadevno aktivno snovjo, je bila ocenjena in ovrednotena v skladu s postopki Skupnosti.
Commission Directive 2005/49/EC
Direktiva Komisije 2005/49/ES
amending, for the purposes of their adaptation to technical progress, Council Directive 72/245/EEC relating to the radio interference (electromagnetic compatibility) of vehicles and Council Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers
o spremembi Direktive Sveta 72/245/EGS o radijskih motnjah (elektromagnetni združljivosti) vozil in Direktive Sveta 70/156/EGS o približevanju zakonodaje držav članic o homologaciji motornih in priklopnih vozil zaradi njune prilagoditve tehničnemu napredku
Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers [1], and in particular Article 13(2) thereof,
ob upoštevanju Direktive Sveta 70/156/EGS z dne 6. februarja 1970 o približevanju zakonodaje držav članic glede homologacije motornih in priklopnih vozil [1] in zlasti člena 13(2) Direktive,
Having regard to Council Directive 72/245/EEC relating to the radio interference (electromagnetic compatibility) of vehicles [2], and in particular Article 4 thereof,
ob upoštevanju Direktive Sveta 72/245/EGS o radijskih motnjah (elektromagnetni združljivosti) vozil [2] in zlasti člena 4 Direktive,
Directive 72/245/EEC is one of the separate directives under the type-approval procedure established by Directive 70/156/EEC.
Direktiva 72/245/EGS je ena od direktiv iz postopka homologacije, določenega z Direktivo 70/156/EGS.
In order to improve safety of vehicles by encouraging development and deployment of technologies utilising automotive short-range radar equipment, the Commission has harmonised by Commission Decision 2004/545/EC of 8 July 2004 on the harmonisation of radio spectrum in the 79 GHz range for the use of automotive short-range radar equipment in the Community [3] and by Commission Decision 2005/50/EC of 17 January 2005 on the harmonisation of the 24 GHz range radio spectrum band for the time-limited use by automotive short-range radar equipment in the Community [4], the use of two radio spectrum frequency bands.
Za izboljšanje varnosti vozil s spodbujanjem razvoja in uporabe tehnologij opreme avtomobilskih radarjev kratkega dosega je Komisija uskladila uporabo dveh radiofrekvenčnih spektrov z Odločbo 2004/545/ES z dne 8. julija 2004 o uskladitvi radijskega spektra v območju 79 GHz za uporabo opreme avtomobilskih radarjev kratkega dosega [3] in Odločbo 2005/50/ES z dne 17. januarja 2005 o uskladitvi radiofrekvenčnega pasu v območju 24 GHz za časovno omejeno uporabo opreme avtomobilskih radarjev kratkega dosega v Skupnosti [4].
The 79 GHz range radio spectrum band has been identified as the most suitable band for long-term development and deployment of automotive short-range radar.
Ugotovljeno je bilo, da je radiofrekvenčni pas v območju 79 GHz najprimernejši radiofrekvenčni pas za dolgoročni in trajni razvoj ter uporabo avtomobilskega radarja kratkega dosega.
Accordingly Decision 2004/545/EC designated and made available for automotive short-range radar equipment the 79 GHz range radio spectrum band on a non-interference and non-protected basis.
V skladu s tem je bil z Odločbo 2004/545/ES za opremo avtomobilskih radarjev kratkega dosega določen in dan na razpolago radiofrekvenčni pas v območju 79 GHz, ki mora delovati brez motenj in zaščite.
However, the technology in the 79 GHz range radio spectrum band is still under development and is not immediately available on a cost-effective basis.
Vendar je tehnologija radiofrekvenčnega pasu v območju 79 GHz še v fazi razvoja in ni takoj na razpolago na stroškovno sprejemljivi podlagi.
The time-limited use of the 24 GHz range radio spectrum band for automotive short-range radars equipment has been permitted by Decision 2005/50/EC.
Časovno omejeno uporabo radiofrekvenčnega pasu v območju 24 GHz pri opremi avtomobilskih radarjev kratkega dosega dovoljuje Odločba 72/245/ES.
The technology using this frequency band is available in the short-term at a reasonable cost, which will make it possible to quickly evaluate the effectiveness of the deployment of automotive short-range radar equipment as regards road safety.
Tehnologija, ki uporablja omenjeni frekvenčni pas, je kratkoročno dostopna po primerni ceni, zaradi česar bo mogoče hitro oceniti vpliv uporabe opreme avtomobilskega radarja kratkega dosega na varnost cestnega prometa.
However, the use of radars of that technology has to be limited to avoid interference with other applications that use the 24 GHz range radio spectrum band.
Vendar je treba uporabo radarjev s to tehnologijo omejiti, da bi se izognili motenju drugih aplikacij, ki uporabljajo radiofrekvenčni pas v območju 24 GHz.
Decision 2005/50/EC permits the use of 24 GHz radar equipment only when originally installed in new vehicles or when replacing one so installed and for a period ending 30 June 2013 at the latest.
Odločba 2005/50/ES dovoljuje uporabo radarske opreme v območju 24 GHz le, če je ta del izvirno vgrajene opreme v novem vozilu ali če zamenjuje izvirno nameščeno opremo, za obdobje, ki se konča najpozneje 30. junija 2013.
However, according to Article 5 of Decision 2005/50/EC, that date may be advanced.
Vendar se v skladu s členom 5 Odločbe 2005/50/ES lahko določi zgodnejši datum.
In accordance with Decision 2005/50/EC, Member States have to set up a monitoring system aiming to quantify the number of vehicles equipped with 24 GHz short-range radars equipment registered in their territory.
V skladu z Odločbo 2005/50/ES morajo države članice vzpostaviti nadzorni sistem, s katerim bodo ugotovile število vozil, registriranih na njihovem ozemlju, ki so opremljena z radarjem kratkega dosega v območju 24 GHz.
It is therefore necessary to provide Member States with the appropriate means to carry out this monitoring.
Zaradi tega je državam članicam treba zagotoviti potrebna sredstva za izvajanje tega nadzora.
Directive 72/245/EEC should therefore be amended accordingly.
Direktivo 72/245/EGS je zato treba ustrezno spremeniti.
The amendments to Directive 72/245/EEC have an impact on Directive 70/156/EEC.
Spremembe Direktive 72/245/EGS vplivajo na Direktivo 70/156/EGS.
It is therefore necessary to amend that directive accordingly.
Navedeno direktivo je zato treba ustrezno spremeniti.
The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Article 13 of Directive 70/156/EEC,
Ukrepi iz navedene direktive so v skladu z mnenjem Odbora za prilagajanje tehničnemu napredku, ustanovljenega s členom 13 Direktive 70/156/EGS –
Amendment to Directive 72/245/EEC
Sprememba Direktive 72/245/EGS
Directive 72/245/EEC is amended as follows:
Direktiva 72/245/EGS se spremeni:
In Annex I, the following points are inserted after point 2.1.12.2:
V Prilogi I se za točko 2.1.12.2 vstavi naslednje:
“24 GHz short-range radar equipment” means a radar as defined in Article 2(2) of Commission Decision 2005/50/EC, and satisfying the performance requirements of Article 4 of that Decision.
‚Oprema radarja kratkega dosega v območju 24 GHz‘ pomeni radar, kakor določa člen 2(2) Odločbe Komisije 2005/50/ES in ki izpolnjuje zahteve glede zmogljivosti iz člena 4 navedene odločbe.
“79 GHz short-range radar equipment” means a radar as defined in Article 2(b) of Commission Decision 2004/545/EC, and satisfying the performance requirements of Article 3 of that Decision.
‚Oprema radarja kratkega dosega v območju 79 GHz‘ pomeni radar, kakor določa člen 2(b) Odločbe Komisije 2004/545/ES in ki izpolnjuje zahteve glede zmogljivosti iz člena 3 navedene odločbe.
In Annex II A, the following points are inserted after point 12.2.7:
V Prilogi II A se za točko 12.2.7 vstavi naslednje:
vehicle equipped with a 24 GHz short-range radar equipment: Yes/No (strike out which is not applicable)
Vozilo je opremljeno z opremo radarja kratkega dosega v območju 24 GHz: da/ne (prečrtati neustrezno).
vehicle equipped with a 79 GHz short-range radar equipment: Yes/No (strike out which is not applicable)’.
Vozilo je opremljeno z opremo radarja kratkega dosega v območju 79 GHz: da/ne (prečrtati neustrezno).“
In the appendix to Annex III A the following points are inserted after point 1.3:
V dodatku k Prilogi III A se za točko 1.3 vstavi naslednje:
Amendment to Directive 70/156/EEC
Sprememba Direktive 70/156/EGS
Directive 70/156/EEC is amended as follows.
Direktiva 70/156/EGS se spremeni:
In Annexes I and III, the following points are inserted after point 12.6.4:
V Prilogah I in III se za točko 12.6.4 vstavi naslednje:
In Annex IX on Side 2 of all models of the Certificate of conformity (COC), item 50 is replaced by the following:
V Prilogi IX se na strani 2 vseh vzorcev potrdila o skladnosti točka 50 zamenja z naslednjim:
vehicle equipped with a 79 GHz short-range radar equipment: Yes/No (strike out which is not applicable)
Vozilo je opremljeno z opremo radarja kratkega dosega v območju 79 GHz: da/ne (prečrtati neustrezno).
Other remarks … ’.
Druge opombe …“
With effect from 1 July 2006, if the provisions laid down in Directive 72/245/EEC, as amended by this Directive, are not fulfilled, Member States, on grounds related to electromagnetic compatibility:
Če določbe Direktive 72/245/EGS, kakor se spremeni s to direktivo, ne bodo v celoti izpolnjene, države članice s 1. julijem 2006 na podlagi razlogov v zvezi z elektromagnetno združljivostjo:
shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC to be no longer valid for the purposes of Article 7(1) of that Directive;
štejejo, da potrdila o skladnosti, ki spremljajo nova vozila skladno z določbami Direktive 70/156/EGS, niso več veljavna v smislu člena 7(1) navedene direktive,
may refuse the registration, sale or entry into service of new vehicles.
lahko zavrnejo registracijo, prodajo ali začetek uporabe novih vozil.
Existing approvals for vehicles not fitted with 24 GHz or 79 GHz short-range radar equipment remain unchanged.
Obstoječe homologacije vozil, ki nimajo opreme radarja kratkega dosega v območju 24 GHz ali 79 GHz, ostanejo nespremenjene.
With effect from 1 July 2013, Member States shall prohibit the registration, sale or entry into service of vehicles equipped with 24 GHz short-range radar equipment.
S 1. julijem 2013 države članice prepovejo registracijo, prodajo ali začetek uporabe vozil, opremljenih z opremo radarja kratkega dosega v območju 24 GHz.
In case the reference date in Article 2(5) of Decision 2005/50/EC is modified in accordance with Article 5 of that Decision, Member States shall prohibit the registration, sale or entry into service of vehicles equipped with 24 GHz short-range radar equipment after the modified reference date.
Če se referenčni datum iz člena 2(5) Odločbe 2005/50/ES spremeni v skladu s členom 5 navedene odločbe, države članice po spremenjenem referenčnem datumu prepovejo registracijo, prodajo ali začetek uporabe vozil, opremljenih z radarjem kratkega dosega v območju 24 GHz.
Member States shall adopt and publish, by 30 June 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 30. junija 2006.
They shall apply those provisions from 1 July 2006.
Te predpise uporabljajo od 1. julija 2006.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication.
Države članice se v sprejetih predpisih sklicujejo na to direktivo ali pa sklic nanjo navedejo ob njihovi uradni objavi.
Member States shall communicate to the Commission the texts of the main provisions of national law, which they adopt in the field governed by this Directive.
Države članice predložijo Komisiji besedila temeljnih predpisov nacionalne zakonodaje, sprejetih na področju, ki ga ureja ta direktiva.
OJ L 42, 23.2.1970, p 1.
UL L 42, 23.2.1970, str. 1.
Directive as last amended by Directive 2004/104/EC.
Direktiva, kakor je bila nazadnje spremenjena z Direktivo 2004/104/ES.
OJ L 241, 13.7.2004, p. 66.’
UL L 241, 13.7.2004, str. 66“
Commission Directive 2005/50/EC
Direktiva Komisije 2005/50/ES
of 11 August 2005
z dne 11. avgusta 2005
on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices
o ponovni razvrstitvi protez kolčnih, kolenskih in ramenskih sklepov v okviru Direktive Sveta 93/42/EGS o medicinskih pripomočkih
Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [1], and in particular Article 13(1)(b) thereof,
ob upoštevanju Direktive Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih [1], in zlasti člena 13(1)(b) Direktive,
Having regard to the request submitted by France and the United Kingdom,
ob upoštevanju zahteve, ki sta jo predložila Francija in Združeno kraljestvo,
On the basis of the classification rules set out in Annex IX to Directive 93/42/EEC, total joint replacements are class IIb medical devices.
Na podlagi pravil razvrščanja, določenih v Prilogi IX k Direktivi 93/42/EGS, so proteze celotnega sklepa medicinski pripomočki razreda IIb.
France and the United Kingdom requested the classification of total joint replacements as class III medical devices by way of derogation from the provisions of Annex IX to Directive 93/42/EEC, in order to ensure an appropriate conformity assessment of total joint replacements before their placing on the market.
Francija in Združeno kraljestvo sta zahtevala, da se proteze celotnega sklepa razvrstijo kot medicinski pripomočki razreda III z odstopanjem od določb Priloge IX k Direktivi 93/42/EGS, da bi zagotovili ustrezno ugotavljanje skladnosti protez celotnega sklepa, preden bi se dale v promet.
Conformity assessment is based on a number of elements such as a proper classification, the designation and monitoring of the notified bodies and the proper implementation of the conformity assessment modules as described in Directive 93/42/EEC.
Ugotavljanje skladnosti temelji na več elementih, kot so ustrezna razvrstitev, označevanje in spremljanje priglašenih organov ter pravilno izvajanje modulov za ugotavljanje skladnosti, kot je opisano v Direktivi 93/42/EGS.
Reclassification by derogation to the classification rules set out in Annex IX to Directive 93/42/EEC is indicated where the shortcomings identified due to the specific characteristics of a product will be more properly addressed under the conformity assessment procedures corresponding to the new category.
Ponovna razvrstitev z odstopanjem od pravil razvrščanja, ki so določena v Prilogi IX k Direktivi 93/42/EGS, je navedena tam, kjer bi bile ugotovljene pomanjkljivosti zaradi posebnosti proizvoda ustrezneje obravnavane po postopkih za ugotavljanje skladnosti, ki ustrezajo novi kategoriji.
Hip, knee and shoulder replacements should be distinguished from other total joint replacements, due to the particular complexity of the joint function to be restored and the consequent increased risk of failure due to the device itself.
Proteze kolka, kolena in ramena je treba razlikovati od ostalih protez celotnih sklepov zaradi posebne zahtevnosti funkcije sklepa, ki ga je treba usposobiti za delovanje, ter posledično povečanega tveganja za okvare zaradi pripomočka samega.
In particular, hip and knee replacements are weight-bearing and extremely sophisticated implants, for which the risk of revision surgery is significantly greater than for other joints.
Zlasti protezi kolka in kolena nosita težo in sta še posebej občutljiva vsadka, pri katerih je tveganje po ponovni operaciji veliko večje kot pri ostalih sklepih.
Shoulder implants are a more recent technique, which are subject to similar dynamic forces; their possible replacement is in principle connected with serious medical problems.
Ramenski vsadki so nedavna tehnika in so prav tako podvrženi podobnim dinamičnim silam; morebitna zamenjava je načeloma povezana z resnimi zdravstvenimi problemi.
Furthermore, hip, knee and shoulder replacement surgery is increasingly taking place on young people with a high life expectancy; consequently, the need for such implants to function properly over the life expectancy of the patients and to reduce revision surgery and its risks has been increased.
Nadalje, operacij zamenjave kolkov, kolen in ramen je vedno več pri mladih ljudeh z visoko pričakovano starostjo; posledično obstaja vedno večja potreba po takih vsadkih, ki bi pravilno delovali vse življenje pacientov ter bi zmanjšali ponovitve operacije in njenih tveganj.
Specific clinical data, including long term performance data are not always available for hip, knee and shoulder replacements before they are placed on the market and put into service; consequently, conclusions on clinical data collected by the manufacturer in the framework of the evaluation of the conformity of these products with the requirements concerning their characteristics and performance referred to in Sections 1 and 3 of Annex I to Directive 93/42/EEC should be subject to particular attention and examination in order to verify the appropriateness of the clinical data available.
Specifični klinični podatki, vključno s podatki o učinkovitosti protez na daljše obdobje, niso zmeraj na voljo za proteze kolkov, kolen in ramen, preden so te dane v promet in uporabo; zato morajo biti zaključki o kliničnih podatkih, ki jih zbere izdelovalec v okviru ocene skladnosti teh proizvodov z zahtevami o značilnostih in učinkovitosti iz poglavij 1 in 3 Priloge I k Direktivi 93/42/EGS deležni posebne pozornosti in pregleda, da bi preverili ustreznost kliničnih podatkov, ki so na voljo.
Total joint replacements can be subject to multiple modifications following their introduction into clinical use and placing on the market, as shown by hip and knee replacements on the market.
Proteze celotnega sklepa so lahko predmet več modifikacij po njihovi uvedbi v klinično uporabo in dajanju v promet, kot so pokazale proteze kolkov in kolen na trgu.
However, experience has shown that what appear at first sight to be minor post-marketing changes to the design of previously trouble-free replacements can lead to serious problems due to unintended consequences, which may lead to early failure and major safety concerns.
Toda izkušnje so pokazale, da to, kar je na prvi pogled videti kot majhna sprememba modela po začetku trženja izdelka, ki je bil prej brezhiben, lahko vodi k resnim težavam zaradi nepredvidenih posledic, ki lahko pripeljejo do zgodnje okvare in resnih skrbi glede varnosti.
In order to achieve the optimal level of safety and health protection and to reduce the design related problems to the lowest level, the design dossier of hip, knee and shoulder replacements, including the clinical data used by the manufacturer to support the claimed performance and the subsequent post-marketing design and manufacturing changes should be examined in detail by the notified body before these devices are introduced in general clinical use.
Za doseganje optimalne stopnje varnosti in varovanja zdravja ter za zmanjšanje problemov v zvezi z modelom do najmanjše možne mere bi moral priglašeni organ, preden se ti pripomočki uvedejo v splošno klinično uporabo, podrobno pregledati načrtovalno dokumentacijo proteze kolkov, kolen in ramen, vključno s kliničnimi podatki izdelovalca, s katerimi utemeljuje zahtevano učinkovitost naknadne spremembe modela po začetku trženja in spremembe v izdelavi.
Consequently, the notified body should, under the full quality assurance system, effectively carry out an examination of the design dossier and of the changes to the approved design in accordance with point 4 of Annex II to Directive 93/42/EEC.
Posledično mora priglašeni organ v okviru sistema celovitega zagotavljanja kakovosti učinkovito izvesti pregled načrtovalne dokumentacije in sprememb k odobrenemu modelu v skladu s točko 4 Priloge II k Direktivi 93/42/EGS.
For these reasons, it is necessary to proceed to the reclassification of hip, knee and shoulder total joint replacements as class III medical devices.
Iz teh razlogov je treba nadaljevati s ponovno razvrstitvijo protez celotnega kolčnega, kolenskega in ramenskega sklepa kot medicinskih pripomočkov razreda III.
It is necessary to provide for an adequate transitional period for hip, knee and shoulder total joint replacements already assessed as class IIb medical devices under the full quality assurance system of Annex II to Directive 93/42/EEC, allowing for their complementary assessment under point 4 of Annex II to the Directive.
Treba je zagotoviti ustrezno prehodno obdobje za proteze celotnega kolčnega, kolenskega in ramenskega sklepa, ki so ocenjene kot medicinski pripomočki razreda IIb v okviru sistema celovitega zagotavljanja kakovosti Priloge II k Direktivi 93/42/EGS, da se omogoči dodatno ocenjevanje po točki 4 Priloge II k Direktivi.