natgillin/translations-raw huggingface dataset:
Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1).
V Prilogi 1 (Proizvodni sektorji) bi bilo treba poglavje 2 (Oprema za osebno zaščito) črtati in ga nadomestiti z naslednjim poglavjem, ki bo veljalo od 21. aprila 2018, ko se bosta začeli uporabljati Uredba (EU) 2016/425 in ustrezna švicarska zakonodaja, razen oddelka IV, ki se začne uporabljati na isti dan kot sklep:
ATTACHMENT A
„POGLAVJE 2
In Annex 1, Product Sectors, Chapter 2, Personal protective equipment should be deleted and replaced by the following one, which shall be effective from 21 April 2018, when Regulation (EU) 2016/425 and the corresponding Swiss legislation become applicable, except for Section IV, which becomes effective on the same day as the Decision:
OPREMA ZA OSEBNO ZAŠČITO
‘CHAPTER 2
ODDELEK I
PERSONAL PROTECTIVE EQUIPMENT
Zakonski in drugi predpisi
SECTION I
Določbe, ki jih zajema člen 1(2)
Legislative, regulatory and administrative provisions
Evropska unija
Provisions covered by Article 1(2)
Uredba (EU) 2016/425 Evropskega parlamenta in Sveta z dne 9. marca 2016 o osebni varovalni opremi in razveljavitvi Direktive Sveta 89/686/EGS (UL L 81, 31.3.2016, str. 51)
European Union
Švica
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51).
Zvezni zakon z dne 12. junija 2009 o varnosti izdelkov (RO 2010 2573)
Switzerland
Odlok z dne 19. maja 2010 o varnosti izdelkov (RO 2010 2583), kakor je bil nazadnje spremenjen 25. oktobra 2017 (RO 2017 5865)
Federal Law of 12 June 2009 on product safety (RO 2010 2573)
Odlok z dne 25. oktobra 2017 o varnosti opreme za osebno zaščito (RO 2017 5859)
Ordinance of 19 May 2010 on product safety (RO 2010 2583) as last amended on 25 October 2017 (RO 2017 5865)
Odlok z dne 17. junija 1996 o švicarskem sistemu akreditacije ter o imenovanju preskusnih laboratorijev in organov za ugotavljanje skladnosti (RO 1996 1904), kakor je bil nazadnje spremenjen 25. novembra 2015 (RO 2016 261)
Ordinance of 25 October 2017 on the safety of personal protective equipment (RO 2017 5859)
ODDELEK II
Ordinance of 17 June 1996 on the Swiss accreditation system and on the designation of test laboratories and conformity assessment bodies (RO 1996 1904), as last amended on 25 November 2015 (RO 2016 261)
Organi za ugotavljanje skladnosti
SECTION II
Odbor, ustanovljen v skladu s členom 10 tega sporazuma, pripravi in redno posodablja seznam organov za ugotavljanje skladnosti v skladu s postopkom iz člena 11 Sporazuma.
Conformity assessment bodies
ODDELEK III
The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.
Organi za uradno imenovanje
SECTION III
Odbor, ustanovljen v skladu s členom 10 tega sporazuma, sestavi in redno posodablja seznam organov za uradno imenovanje, ki jih priglasita pogodbenici.
Designating authorities
ODDELEK IV
The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.
Posebna pravila v zvezi z imenovanjem organov za ugotavljanje skladnosti
SECTION IV
Organi za uradno imenovanje pri imenovanju organov za ugotavljanje skladnosti upoštevajo splošna načela iz Priloge 2 k temu sporazumu in merila za ocenjevanje iz poglavja V Uredbe (EU) 2016/425.
Special rules relating to the designation of conformity assessment bodies
ODDELEK V
For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Chapter V of Regulation (EU) 2016/425.
Dodatne določbe
SECTION V
Gospodarski subjekti
Supplementary provisions
Posebne obveznosti gospodarskih subjektov v skladu z zakonodajo iz oddelka I
Economic operators
V skladu z zakonodajo iz oddelka I za gospodarske subjekte s sedežem v EU ali Švici veljajo enakovredne obveznosti.
Specific obligations of economic operators pursuant to the legislation under Section I
Da se prepreči nepotrebno podvajanje obveznosti:
Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.
za namene obveznosti iz členov 8(6) in 10(3) Uredbe (EU) 2016/425 ter ustreznih določb Švice zadostuje navedba imena, registriranega trgovskega imena ali registrirane blagovne znamke in poštnega naslova, na katerem je proizvajalec s sedežem na ozemlju Evropske unije ali Švice dosegljiv.
In order to avoid unnecessary duplication of obligations:
Če proizvajalec nima sedeža na ozemlju Evropske unije ali Švice, zadostuje navedba imena, registriranega trgovskega imena ali registrirane blagovne znamke in poštnega naslova, na katerem je dosegljiv uvoznik s sedežem na ozemlju Evropske unije ali Švice;
for the purpose of the obligations in Articles 8(6) and 10(3) of Regulation (EU) 2016/425 and the corresponding Swiss provisions, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the manufacturer established within the territory of either the European Union or Switzerland can be contacted.
za namene obveznosti iz členov 8(3) in 10(8) Uredbe (EU) 2016/425 ter ustreznih določb Švice zadostuje, da proizvajalec s sedežem na ozemlju Evropske unije ali Švice hrani tehnično dokumentacijo in izjavo EU o skladnosti deset let po tem, ko je bila oprema za osebno zaščito dana na trg Evropske unije ali Švice.
In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the importer established within the territory of either the European Union or Switzerland can be contacted;
Če proizvajalec nima sedeža na ozemlju Evropske unije ali Švice, zadostuje, da uvoznik s sedežem na ozemlju Evropske unije ali Švice omogoča organom za nadzor trga dostop do izvoda izjave EU o skladnosti in zagotovi, da je tehnična dokumentacija tem organom na zahtevo na voljo deset let po tem, ko je bila oprema za osebno zaščito dana na trg Evropske unije ali Švice;
for the purpose of the obligations in Article 8(3) and 10(8) of Regulation (EU) 2016/425 and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keeps the technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market in either the European Union or Switzerland.
za namene obveznosti iz drugega pododstavka člena 8(4) in člena 10(6) Uredbe (EU) 2016/425 ter ustreznih določb Švice zadostuje, da take obveznosti izpolnjuje proizvajalec s sedežem na ozemlju Evropske unije ali Švice oziroma, če proizvajalec nima sedeža na ozemlju Evropske unije ali Švice, uvoznik s sedežem na ozemlju Evropske unije ali Švice.
In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient that the importer established within the territory of either the European Union or Switzerland keeps a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensures that the technical documentation can be made available to those authorities upon request for 10 years after the PPE has been placed on the market in either the European Union or Switzerland;
Pooblaščeni zastopnik
for the purpose of the obligations in Article 8(4), second subparagraph, and 10(6) of Regulation (EU) 2016/425 and the corresponding Swiss provisions, it shall be sufficient that such obligations be fulfilled by the manufacturer established within the territory of either the European Union or Switzerland, or, in case the manufacturer is not established within the territory of either the European Union or Switzerland, by the importer established within the territory of either the European Union or Switzerland.
Za namene obveznosti iz člena 9(2) Uredbe (EU) 2016/425 in ustreznih določb Švice pooblaščeni zastopnik pomeni vsako fizično ali pravno osebo s sedežem na ozemlju Evropske unije ali Švice, ki jo je proizvajalec pisno pooblastil, da deluje v njegovem imenu, v skladu s členom 9(1) Uredbe (EU) 2016/425 ali ustreznimi določbami Švice.
Authorised representative
Sodelovanje z organi za nadzor trga
For the purpose of the obligation in Article 9(2) of Regulation (EU) 2016/425 and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 9(1) of Regulation (EU) 2016/425 or the corresponding Swiss provisions.
Pristojni nacionalni organ za nadzor trga države članice Evropske unije ali Švice lahko na utemeljeno zahtevo od zadevnih gospodarskih subjektov v Evropski uniji in Švici zahteva predložitev vseh potrebnih informacij in dokumentacije, ki dokazujejo skladnost opreme za osebno zaščito z zakonodajo iz oddelka I.
Cooperation with market surveillance authorities
Navedeni organ se lahko obrne na gospodarski subjekt s sedežem na ozemlju druge pogodbenice neposredno ali s pomočjo pristojnega nacionalnega organa za nadzor trga druge pogodbenice.
The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of a PPE with the legislation in section I.
Od proizvajalcev ali, kadar je primerno, pooblaščenih zastopnikov in uvoznikov lahko zahteva predložitev dokumentacije v jeziku, ki ga navedeni organ razume brez težav.
That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party.
Od gospodarskih subjektov lahko zahteva, naj sodelujejo pri kateri koli dejavnosti, katere cilj je preprečiti tveganje, povezano z opremo za osebno zaščito.
It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority.
Izmenjava izkušenj
It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the PPE.
Švicarski organi za uradno imenovanje lahko sodelujejo pri izmenjavi izkušenj med nacionalnimi organi držav članic iz člena 35 Uredbe (EU) 2016/425.
Exchange of experience
Usklajevanje organov za ugotavljanje skladnosti
Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 35 of Regulation (EU) 2016/425.
Švicarski organi za ugotavljanje skladnosti lahko neposredno ali prek pooblaščenih zastopnikov sodelujejo v mehanizmih usklajevanja in sodelovanja, določenih v členu 36 Uredbe (EU) 2016/425.
Coordination of conformity assessment bodies
Vzajemna pomoč organov za nadzor trga
Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 36 of Regulation (EU) 2016/425, directly or by means of designated representatives.
V skladu s členom 9(1) Sporazuma pogodbenici zagotovita učinkovito sodelovanje in izmenjavo informacij med svojimi organi za nadzor trga.
Mutual assistance of market surveillance authorities
Organi za nadzor trga držav članic in Švice sodelujejo ter si izmenjujejo informacije.
Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities.
Med seboj si ustrezno pomagajo s predložitvijo informacij ali dokumentacije v zvezi z zadevnimi gospodarskimi subjekti, ki imajo sedež v državi članici ali Švici.
The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information.
Postopek za obravnavanje opreme za osebno zaščito, ki pomeni tveganje, ki ni omejeno na nacionalno ozemlje
They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.
Kadar organi za nadzor trga države članice ali Švice sprejmejo ukrepe ali imajo zadostne razloge za domnevo, da oprema za osebno zaščito iz tega poglavja pomeni tveganje za zdravje ali varnost oseb iz zakonodaje v oddelku I tega poglavja, ter če menijo, da neskladnost ni omejena na njihovo nacionalno ozemlje, v skladu s členom 12(4) tega sporazuma Evropsko komisijo, druge države članice in Švico nemudoma obvestijo:
Procedure for dealing with PPE presenting a risk not restricted to the national territory
o rezultatih vrednotenja in ukrepih, ki so jih zahtevali od gospodarskega subjekta,
Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that a PPE covered by this Chapter presents a risk to the health or safety of persons covered by the legislation in Section I of this Chapter, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:
kadar zadevni gospodarski subjekt ne sprejme ustreznih korektivnih ukrepov, o vseh ustreznih začasnih ukrepih za prepoved ali omejitev dostopnosti opreme za osebno zaščito na svojem nacionalnem trgu, za umik opreme za osebno zaščito z navedenega trga ali njen odpoklic.
the results of the evaluation and of the actions which they have required the economic operator to take;
Te informacije vsebujejo vse razpoložljive podatke, zlasti podatke, potrebne za identifikacijo neskladne opreme za osebno zaščito, njenega porekla, vrsto domnevne neskladnosti in tveganja ter vrsto in trajanje sprejetih nacionalnih ukrepov ter pojasnilo zadevnega gospodarskega subjekta.
where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the PPE being made available on their national market, to withdraw the PPE from that market or to recall it.
Zlasti vsebujejo navedbe o tem, ali je neskladnost posledica katerega izmed naslednjih vzrokov:
This information shall include all available details, in particular the data necessary for the identification of the non-compliant PPE, their origin, 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.
oprema za osebno zaščito ne izpolnjuje zahtev, povezanih z zdravjem ali varnostjo oseb iz zakonodaje v oddelku I, ali
In particular, it shall be indicated whether the non-compliance is due to either:
pomanjkljivosti harmoniziranih standardov, navedenih v zakonodaji v oddelku I.
failure of the PPE to meet requirements relating to the health or safety of persons referred to in the legislation in section I, or
Švica ali države članice Evropsko komisijo in druge nacionalne organe nemudoma obvestijo o vseh sprejetih ukrepih in drugih razpoložljivih informacijah, ki se nanašajo na neskladnost zadevne opreme za osebno zaščito.
shortcomings in the harmonised standards referred to in the legislation in Section I.
Države članice in Švica zagotovijo takojšnje sprejetje ustreznih omejevalnih ukrepov v zvezi z zadevno opremo za osebno zaščito, kot je umik opreme za osebno zaščito s trga.
Switzerland or Member States shall without delay inform the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the PPE concerned.
Zaščitni postopek v primeru ugovorov zoper nacionalne ukrepe
Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the PPE concerned, such as withdrawal of the PPE from their market, without delay.
Če se Švica ali država članica ne strinjata z nacionalnim ukrepom iz odstavka 5, o svojih ugovorih obvestita Evropsko komisijo v treh mesecih po prejemu informacij.
Safeguard procedure in case of objections against national measures
Če na koncu postopka iz odstavka 5 država članica ali Švica vloži ugovor zoper ukrep, ki ga sprejmeta Švica oziroma država članica, ali če Komisija meni, da je nacionalni ukrep v nasprotju z ustrezno zakonodajo iz oddelka I, se Evropska komisija nemudoma posvetuje z državami članicami in Švico ter prek švicarskih organov z zadevnimi gospodarskimi subjekti.
Should Switzerland or a Member State disagree with the national measure in paragraph 5, it shall inform the European Commission of its objections within three months of the receipt of the information.
Oceni nacionalni ukrep, da bi ugotovila, ali je upravičen ali ne.
Where, on completion of the procedure set out in paragraph 5, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State or where the Commission considers a national measure to be contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators.
Če se nacionalni ukrep oceni kot:
It shall evaluate the national measure, in order to determine whether the national measure is justified or not.
upravičen, vse države članice in Švica sprejmejo potrebne ukrepe za umik neskladne opreme za osebno zaščito s svojih trgov ter o tem obvestijo Komisijo;
justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant PPE is withdrawn from their markets, and shall inform the Commission accordingly;
Pogodbenica lahko na podlagi odstavka 8 vprašanje pošlje Odboru, ustanovljenemu v skladu s členom 10 tega sporazuma.
unjustified, the Member State concerned or Switzerland shall withdraw that measure.
Skladna oprema za osebno zaščito, ki vseeno pomeni tveganje
A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.
Kadar država članica ali Švica ugotovi, da je oprema za osebno zaščito, katere dostopnost je gospodarski subjekt omogočil na trgu EU ali Švice, sicer skladna z zakonodajo iz oddelka I tega poglavja, vendar pomeni tveganje za zdravje ali varnost oseb, sprejme vse ustrezne ukrepe ter nemudoma obvesti Evropsko komisijo, druge države članice in Švico.
Compliant PPE which nevertheless present a risk
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.
Where a Member State or Switzerland finds that, although a PPE that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk for the health or safety of persons, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland.
Komisija se nemudoma posvetuje z državami članicami in Švico ter prek švicarskih organov z zadevnimi gospodarskimi subjekti ter ovrednoti nacionalne ukrepe, da bi ugotovila, ali je nacionalni ukrep upravičen, in po potrebi predlaga ustrezne ukrepe.
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.
Zaščitna klavzula za primere nerešenih razhajanj med pogodbenicama
Safeguard clause in case of remaining disagreement between the Parties
Če Odbor meni, da je ukrep:
In case of a disagreement between the Parties on measures at stake in paragraphs 6 and 7 above, the issue will be forwarded to the Committee established under Article 10 of this Agreement, which will decide on an appropriate course of action, including the possibility to have an expert study carried out.
upravičen, pogodbenici sprejmeta potrebne ukrepe za umik opreme za osebno zaščito s svojih trgov;
Where the Committee considers that the measure is:
neupravičen, ga nacionalni organ države članice ali Švice umakne.“
justified, the Parties shall take the measures necessary to ensure that the PPE is withdrawn from their market;
DODATEK B
unjustified, the national authority of the Member State or Switzerland shall withdraw the measure.’
Poglavje 4 (Medicinski pripomočki) Priloge 1 (Proizvodni sektorji) bi bilo treba črtati in nadomestiti z naslednjim:
ATTACHMENT B
„POGLAVJE 4
In Annex 1, Product Sectors, Chapter 4, Medical Devices should be deleted and replaced by the following one:
MEDICINSKI PRIPOMOČKI
‘CHAPTER 4
Direktiva Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1882/2003 Evropskega parlamenta in Sveta z dne 29. septembra 2003 (UL L 284, 31.10.2003, str. 1)
MEDICAL DEVICES
Direktiva Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1882/2003 Evropskega parlamenta in Sveta z dne 29. septembra 2003 (UL L 284, 31.10.2003, str. 1)
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1).
Direktiva 98/79/ES Evropskega parlamenta in Sveta z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih (UL L 331, 7.12.1998, str. 1), kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1882/2003 Evropskega parlamenta in Sveta z dne 29. septembra 2003 (UL L 284, 31.10.2003, str. 1) in popravljena s popravkom (UL L 22, 29.1.1999, str. 75, in UL L 6, 10.1.2002, str. 70)
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1)
Odločba Komisije 2002/364/ES z dne 7. maja 2002 o skupnih tehničnih specifikacijah za in vitro diagnostične medicinske pripomočke (UL L 131, 16.5.2002, str. 17)
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1), as last amended by Regulation (EC) No 1882/2003 of the European Parliament and the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1) and corrected by Corrigenda (OJ L 22, 29.1.1999, p. 75 and OJ L 6, 10.1.2002, p. 70).
Direktiva Komisije 2003/12/ES z dne 3. februarja 2003 o ponovni klasifikaciji prsnih vsadkov v okviru Direktive 93/42/EGS o medicinskih pripomočkih (UL L 28, 4.2.2003, str. 43)
Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L 131, 16.5.2002, p. 17).
Uredba Komisije (EU) št. 722/2012 z dne 8. avgusta 2012 o posebnih zahtevah v zvezi z zahtevami iz direktiv Sveta 90/385/EGS in 93/42/EGS glede aktivnih medicinskih pripomočkov za vsaditev in medicinskih pripomočkov, izdelanih z uporabo tkiv živalskega izvora (UL L 22, 9.8.2012, str. 3)