natgillin/translations-raw huggingface dataset:
Where the market surveillance authorities of one Member State have sufficient reason to believe that PPE covered by this Regulation presents a risk to the health or safety of persons, they shall carry out an evaluation in relation to the PPE concerned covering all relevant requirements laid down in this Regulation.
Kadar organi za nadzor trga ene države članice upravičeno domnevajo, da osebna varovalna oprema, ki jo zajema ta uredba, predstavlja tveganje za zdravje ali varnost ljudi, ocenijo, ali zadevna osebna varovalna oprema izpolnjuje vse ustrezne zahteve iz te uredbe.
Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the PPE does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the PPE into compliance with those requirements, to withdraw the PPE from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.
Kadar organi za nadzor trga med oceno iz prvega pododstavka ugotovijo, da osebna varovalna oprema ne izpolnjuje zahtev iz te uredbe, od zadevnega gospodarskega subjekta brez odlašanja zahtevajo, da sprejme vse ustrezne korektivne ukrepe, do bo osebna varovalna oprema izpolnila navedene zahteve, jo umakne s trga ali jo odpokliče v razumnem roku, ki ga določijo glede na naravo tveganja.
Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.
Za ukrepe iz drugega pododstavka tega odstavka se uporablja člen 21 Uredbe (ES) št. 765/2008.
Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.
Kadar organi za nadzor trga menijo, da neizpolnjevanje ni omejeno na njihovo nacionalno ozemlje, Komisijo in druge države članice obvestijo o rezultatih ocene in ukrepih, ki so jih zahtevali od gospodarskega subjekta.
The economic operator shall ensure that all appropriate corrective action is taken in respect of all the PPE concerned that it has made available on the market throughout the Union.
Gospodarski subjekt zagotovi sprejetje vseh ustreznih korektivnih ukrepov v zvezi z vsemi zadevnimi deli osebne varovalne opreme, katerih dostopnost je omogočil na trgu po vsej Uniji.
Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the PPE being made available on their national market, to withdraw the PPE from that market or to recall it.
Kadar zadevni gospodarski subjekt v roku iz drugega pododstavka odstavka 1 ne sprejme ustreznih korektivnih ukrepov, organi za nadzor trga sprejmejo vse ustrezne začasne ukrepe za prepoved ali omejitev omogočanja dostopnosti osebne varovalne opreme na nacionalnem trgu, njen umik ali odpoklic s trga.
The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant PPE, the origin of the PPE, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.
Informacije iz drugega pododstavka odstavka 4 vključujejo vse razpoložljive podrobnosti, zlasti podatke, potrebne za identifikacijo neskladne osebne varovalne opreme, njenega porekla, vrste domnevne neskladnosti in s tem povezanega tveganja, vrsto in trajanje sprejetih nacionalnih ukrepov ter argumente zadevnega gospodarskega subjekta.
failure of the PPE to meet requirements relating to the health or safety of persons; or
osebna varovalna oprema ne izpolnjuje zahtev v zvezi z zdravjem ali varnostjo oseb; ali
shortcomings in the harmonised standards referred to in Article 14 conferring a presumption of conformity.
harmonizirani standardi iz člena 14 v zvezi z domnevo o skladnosti so pomanjkljivi.
Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the PPE concerned, and, in the event of disagreement with the adopted national measure, of their objections.
Države članice, razen države članice, ki je začela postopek na podlagi tega člena, Komisijo in ostale države članice brez odlašanja obvestijo o vseh sprejetih ukrepih in vseh dodatnih informacijah, ki so jim na voljo v zvezi z neskladnostjo zadevne osebne varovalne opreme, v primeru nestrinjanja s sprejetim nacionalnim ukrepom pa predložijo svoje ugovore.
Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.
Kadar država članica ali Komisija v treh mesecih po prejemu informacij iz drugega pododstavka odstavka 4 ne predloži ugovorov glede začasnega ukrepa, ki ga je sprejela država članica, se šteje, da je ta ukrep upravičen.
Member States shall ensure that appropriate restrictive measures, such as withdrawal of the PPE from the market, are taken in respect of the PPE concerned without delay.
Države članice zagotovijo, da so ustrezni omejevalni ukrepi v zvezi z zadevno osebno varovalno opremo, na primer umik osebne varovalne opreme s trga, sprejeti brez odlašanja.
Where, on completion of the procedure set out in Article 38(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure.
Kadar so po zaključku postopka iz člena 38(3) in (4) vloženi ugovori zoper ukrep države članice ali kadar Komisija meni, da je nacionalni ukrep v nasprotju z zakonodajo Unije, Komisija začne brez odlašanja posvetovanja z državami članicami in zadevnim gospodarskim subjektom oziroma subjekti ter oceni nacionalni ukrep.
If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant PPE is withdrawn from their market, and shall inform the Commission accordingly.
Če se nacionalni ukrep šteje za upravičenega, vse države članice sprejmejo potrebne ukrepe, da zagotovijo umik neskladne osebne varovalne opreme z nacionalnih trgov in o tem obvestijo Komisijo.
Where the national measure is considered justified and the non-compliance of the PPE is attributed to shortcomings in the harmonised standards referred to in point (b) of Article 38(5) of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
Kadar nacionalni ukrep šteje za upravičenega, osebna varovalna oprema pa ni skladna zaradi pomanjkljivosti harmoniziranih standardov iz točke (b) člena 38(5) te uredbe, Komisija uporabi postopek iz člena 11 Uredbe (EU) št. 1025/2012.
Compliant PPE which presents a risk
Skladna osebna varovalna oprema, ki predstavlja tveganje
Where, having carried out an evaluation under Article 38(1), a Member State finds that although PPE is in compliance with this Regulation, it presents a risk to the health or safety of persons, it shall require the relevant economic operator to take all appropriate measures to ensure that the PPE concerned, when placed on the market, no longer presents that risk, to withdraw the PPE from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.
Kadar država članica po izvedbi ocene iz člena 38(1) ugotovi, da osebna varovalna oprema, čeprav je skladna s to uredbo, predstavlja tveganje za zdravje ali varnost ljudi, od zadevnega gospodarskega subjekta zahteva, da sprejme vse ustrezne ukrepe, s katerimi zagotovi, da zadevna osebna varovalna oprema takrat, ko je dana na trg, ne predstavlja več tega tveganja, ali pa osebno varovalno opremo umakne s trga ali jo odpokliče v razumnem roku, ki ga določi glede na naravo tveganja.
The economic operator shall ensure that corrective action is taken in respect of all the PPE concerned that he has made available on the market throughout the Union.
Gospodarski subjekt zagotovi sprejetje korektivnih ukrepov v zvezi z vsemi zadevnimi deli osebne varovalne opreme, katerih dostopnost je omogočil na trgu po vsej Uniji.
That information shall include all available details, in particular the data necessary for the identification of the PPE concerned, the origin and the supply chain of the PPE, the nature of the risk involved and the nature and duration of the national measures taken.
Informacije vsebujejo vse razpoložljive podrobnosti, zlasti podatke, potrebne za identifikacijo zadevne osebne varovalne opreme, poreklo in dobavno verigo osebne varovalne opreme, vrsto s tem povezanega tveganja ter vrsto in trajanje sprejetih nacionalnih ukrepov.
The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken.
Komisija se brez odlašanja posvetuje z državami članicami in zadevnim gospodarskim subjektom oziroma subjekti ter oceni sprejete nacionalne ukrepe.
On the basis of the results of that evaluation, the Commission shall decide by means of implementing acts whether the national measure is justified or not and, where necessary, propose appropriate measures.
Na podlagi rezultatov te ocene Komisija z izvedbenimi akti odloči, ali je nacionalni ukrep upravičen ali ne, in po potrebi predlaga ustrezne ukrepe.
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 44(3).
Izvedbeni akti iz prvega pododstavka tega odstavka se sprejmejo v skladu s postopkom pregleda iz člena 44(3).
On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 44(4).
V izredno nujnih in ustrezno utemeljenih primerih v zvezi z varovanjem zdravja in varnosti ljudi sprejme Komisija v skladu s postopkom iz člena 44(4) izvedbene akte, ki se začnejo uporabljati takoj.
Without prejudice to Article 38, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:
Brez poseganja v člen 38 država članica od zadevnega gospodarskega subjekta zahteva, da zadevno neskladnost odpravi, kadar ugotovi katero od naslednjih dejstev:
the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 17 of this Regulation;
oznaka CE je bila nameščena tako, da je kršen člen 30 Uredbe (ES) št. 765/2008 ali člen 17 te uredbe;
the identification number of the notified body involved in the production control phase has been affixed in violation of Article 17 or has not been affixed;
identifikacijska številka priglašenega organa, ki je bil udeležen v fazi nadzora proizvodnje, je bila nameščena tako, da je kršen člen 17, ali ni bila nameščena;
the EU declaration of conformity has not been drawn up or has not been drawn up correctly;
izjava EU o skladnosti ni bila pripravljena ali ni bila pripravljena pravilno;
the information referred to in Article 8(6) or Article 10(3) is absent, false or incomplete;
informacije iz člena 8(6) ali člena 10(3) manjkajo, so napačne ali nepopolne;
any other administrative requirement provided for in Article 8 or Article 10 is not fulfilled.
ni izpolnjena katera druga upravna zahteva iz člena 8 ali člena 10.
Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the PPE being made available on the market or ensure that it is recalled or withdrawn from the market.
Kadar se neskladnost iz odstavka 1 nadaljuje, zadevna država članica sprejme vse ustrezne ukrepe za omejevanje ali prepoved omogočanja dostopnosti osebne varovalne opreme na trgu ali pa zagotovi njen odpoklic ali umik s trga.
In order to take into account technical progress and knowledge or new scientific evidence with respect to the category of a specific risk, the Commission shall be empowered to adopt delegated acts in accordance with Article 43 in order to amend Annex I by reclassifying the risk from one category to another.
Na Komisijo se prenese pooblastilo, da v skladu s členom 43 sprejme delegirane akte, da zaradi upoštevanja tehničnega napredka in znanja ali novih znanstvenih dokazov glede kategorije posebne nevarnosti spremeni Prilogo I, pri čemer nevarnost prerazvrsti iz ene kategorije v drugo.
A Member State which has concerns about the classification of a risk into a specific risk category referred to in Annex I shall immediately inform the Commission of its concerns and provide reasons in support.
Država članica, ki ima pomisleke glede razvrstitve nevarnosti v posebno kategorijo nevarnosti iz Priloge I, Komisijo nemudoma obvesti o svojih pomislekih in jih obrazloži.
Prior to adopting a delegated act, the Commission shall carry out a thorough assessment of the risks that require reclassification and the impact of such reclassification.
Komisija pred sprejetjem delegiranega akta opravi temeljito oceno nevarnosti, ki jih je treba prerazvrstiti, in vpliv take prerazvrstitve.
The power to adopt delegated acts referred to in Article 42 shall be conferred on the Commission for a period of five years from 21 April 2018.
Prenos pooblastila se samodejno podaljša za enako obdobje, razen če Evropski parlament ali Svet nasprotuje temu podaljšanju najpozneje tri mesece pred koncem vsakega obdobja.
The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period.
Zlasti je pomembno, da Komisija pred sprejetjem teh delegiranih aktov ravna v skladu s svojo običajno prakso ter se posvetuje s strokovnjaki, vključno s strokovnjaki držav članic.
The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Prenos pooblastila iz člena 42 lahko kadar koli prekliče Evropski parlament ali Svet.
The delegation of powers referred to in Article 42 may be revoked at any time by the European Parliament or by the Council.
Sklep začne učinkovati dan po njegovi objavi v Uradnem listu Evropske unije ali na poznejši dan, ki je določen v navedenem sklepu.
It shall not affect the validity of any delegated acts already in force.
Delegiran akt, sprejet na podlagi člena 42, začne veljati le, če mu niti Evropski parlament niti Svet ne nasprotuje v roku dveh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu o tem aktu ali če pred iztekom tega roka tako Evropski parlament kot Svet obvestita Komisijo, da mu ne bosta nasprotovala.
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
Ta rok se na pobudo Evropskega parlamenta ali Sveta podaljša za dva meseca..
A delegated act adopted pursuant to Article 42 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
Člen 44
Article 44
Komisiji pomaga odbor.
The Commission shall be assisted by a committee.
Pri sklicevanju na ta odstavek se uporablja člen 4 Uredbe (EU) št. 182/2011.
That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
Pri sklicevanju na ta odstavek se uporablja člen 5 Uredbe (EU) št. 182/2011.
Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
Pri sklicevanju na ta odstavek se uporablja člen 8 Uredbe (EU) št. 182/2011 v povezavi s členom 5 Uredbe.
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Komisija se z odborom posvetuje o vseh vprašanjih, za katera se v skladu z Uredbo (EU) št. 1025/2012 ali v skladu s katero koli drugo zakonodajo Unije zahteva posvetovanje s sektorskimi strokovnjaki.
Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
Odbor lahko poleg tega obravnava vsa vprašanja v zvezi z uporabo te uredbe, ki jih v skladu s poslovnikom odbora predlaga bodisi njegov predsednik bodisi predstavnik države članice.
The committee shall be consulted by the Commission on any matter for which consultation of sectoral experts is required by Regulation (EU) No 1025/2012 or by any other Union legislation.
POGLAVJE VIII
The committee may furthermore examine any other matter concerning the application of this Regulation raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.
PREHODNE IN KONČNE DOLOČBE
CHAPTER VIII
Člen 45
Article 45
Države članice določijo pravila o kaznih, ki se uporabljajo za kršitve določb te uredbe, ki jih zakrivijo gospodarski subjekti.
Penalties
Taka pravila lahko v primeru resnih kršitev vključujejo kazenske sankcije.
Member States shall lay down the rules on penalties applicable to infringements by economic operators of the provisions of this Regulation.
Kazni, ki jih določijo, morajo biti učinkovite, sorazmerne in odvračilne.
Such rules may include criminal penalties for serious infringements.
Države članice o teh pravilih uradno obvestijo Komisijo do 21. marca 2018 in jo brez odlašanja uradno obvestijo o vsakršni naknadni spremembi, ki nanje vpliva.
The penalties provided for shall be effective, proportionate and dissuasive.
Države članice sprejmejo vse potrebne ukrepe, da zagotovijo izvrševanje pravil o kaznih, ki se uporabljajo za kršitve določb te uredbe, ki jih zakrivijo gospodarski subjekti.
Member States shall notify those rules to the Commission by 21 March 2018, and shall notify it without delay of any subsequent amendment affecting them.
Člen 46
Member States shall take all measures necessary to ensure that their rules on penalties applicable to infringements by economic operators of the provisions of this Regulation are enforced.
Razveljavitev
Article 46
Direktiva 89/686/EGS se razveljavi z učinkom od 21. aprila 2018.
Repeal
Sklicevanja na razveljavljeno direktivo se štejejo za sklicevanja na to uredbo in se berejo v skladu s korelacijsko tabelo iz Priloge X.
Directive 89/686/EEC is repealed with effect from 21 April 2018.
Člen 47
References to the repealed Directive shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex X.
Prehodne določbe
Article 47
Brez poseganja v odstavek 2 države članice ne ovirajo omogočanja dostopnosti na trgu proizvodov, zajetih v Direktivi 89/686/EGS, ki so skladni z navedeno direktivo in so bili dani na trg pred 21. aprilom 2019.
Transitional provisions
Certifikati o ES pregledu-tipa in odločitve o odobritvi, ki se izdajo na podlagi Direktive 89/686/EGS, ostanejo veljavni do 21. aprila 2023, razen če njihova veljavnost poteče pred navedenim datumom.
Without prejudice to paragraph 2, Member States shall not impede the making available on the market of products covered by Directive 89/686/EEC which are in conformity with that Directive and which were placed on the market before 21 April 2019.
Člen 48
EC type-examination certificates and approval decisions issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date.
Začetek veljavnosti in uporaba
Article 48
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
Entry into force and application
Ta uredba se uporablja od 21. aprila 2018, z izjemo:
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
členov 20 do 36 in člena 44, ki se uporabljajo od 21. oktobra 2016;
This Regulation shall apply from 21 April 2018, with the exception of:
člena 45(1), ki se uporablja od 21. marca 2018.
Articles 20 to 36 and Article 44, which shall apply from 21 October 2016;
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
Article 45(1), which shall apply from 21 March 2018.
V Strasbourgu, 9. marca 2016
The President
UL C 451, 16.12.2014, str.
OJ C 451, 16.12.2014, p.
Stališče Evropskega parlamenta z dne 20. januarja 2016 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 12. februarja 2016.
76.
Direktiva Sveta 89/686/EGS z dne 21. decembra 1989 o približevanju zakonodaj držav članic v zvezi z osebno zaščitno opremo (UL L 399, 30.12.1989, str. 18).
Position of the European Parliament of 20 January 2016 (not yet published in the Official Journal) and decision of the Council of 12 February 2016.
UL C 136, 4.6.1985, str.
Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 399, 30.12.1989, p. 18).
1.
OJ C 136, 4.6.1985, p.
Uredba (EU) št. 1025/2012 Evropskega parlamenta in Sveta z dne 25. oktobra 2012 o evropski standardizaciji, spremembi direktiv Sveta 89/686/EGS in 93/15/EGS ter direktiv 94/9/ES, 94/25/ES, 95/16/ES, 97/23/ES, 98/34/ES, 2004/22/ES, 2007/23/ES, 2009/23/ES in 2009/105/ES Evropskega parlamenta in Sveta ter razveljavitvi Sklepa Sveta 87/95/EGS in Sklepa št. 1673/2006/ES Evropskega parlamenta in Sveta (UL L 316, 14.11.2012, str.
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC(52), 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p.
Uredba (ES) št. 765/2008 Evropskega parlamenta in Sveta z dne 9. julija 2008 o določitvi zahtev za akreditacijo in nadzor trga v zvezi s trženjem proizvodov ter razveljavitvi Uredbe (EGS) št. 339/93 (UL L 218, 13.8.2008, str.
12).
30).
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
Sklep št. 768/2008/ES Evropskega parlamenta in Sveta z dne 9. julija 2008 o skupnem okviru za trženje proizvodov in razveljavitvi Sklepa Sveta 93/465/EGS (UL L 218, 13.8.2008, str.
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p.
82).
82).
Direktiva Sveta 89/656/EGS z dne 30. novembra 1989 o minimalnih zdravstvenih in varnostnih zahtevah za osebno varovalno opremo, ki jo delavci uporabljajo na delovnem mestu (tretja posebna direktiva v smislu člena 16(1) Direktive 89/391/EGS) (UL L 393, 30.12.1989, str.
Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 393, 30.12.1989, p. 18).
18).