natgillin/translations-raw huggingface dataset:
An accredited in-house body shall not be notified to the Member States or the Commission, but information concerning its accreditation shall be given by the undertaking of which it forms a part or by the national accreditation body to the notifying authority at the request of that authority.
Akreditirani interni organ ni priglašen državam članicam ali Komisiji, vendar mora podjetje, katerega del je, ali nacionalni akreditacijski organ na zahtevo informacije o njegovi akreditaciji posredovati priglasitvenim organom.
Article R22
Člen R22
Application for notification
Zahteva za priglasitev
A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.
Organ za ugotavljanje skladnosti predloži zahtevo za priglasitev priglasitvenemu organu države članice, v kateri je ustanovljen.
That application shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the product or products for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article [R17] of this ... [act].
Zahtevi mora biti priložen opis dejavnosti ugotavljanja skladnosti, modul ali moduli za ugotavljanje skladnosti in proizvod ali proizvodi, za katere organ trdi, da je pristojen, ter tudi certifikat o akreditaciji, če obstaja, ki ga je izdal nacionalni akreditacijski organ, ki je bilo uspešno na strokovnem vrednotenju, ki potrjuje, da organ za ugotavljanje skladnosti izpolnjuje zahteve iz člena [R17] tega … [akt].
Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article [R17].
Če zadevni organ za ugotavljanje skladnosti ne more zagotoviti certifikata o akreditaciji, predloži priglasitvenemu organu vsa potrebna dokumentarna dokazila za preverjanje, priznavanje in redno spremljanje njegove skladnosti z zahtevami iz člena [R17].
Article R23
Člen R23
Notification procedure
Priglasitveni postopek
Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article [R17].
Priglasitveni organi lahko priglasijo samo tiste organe za ugotavljanje skladnosti, ki izpolnjujejo zahteve iz člena [R17].
They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.
Komisijo in druge države članice obvestijo z uporabo elektronskega orodja za priglasitev, ki ga je razvila in s katerim upravlja Komisija.
The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and product or products concerned and the relevant attestation of competence.
Priglasitev vključuje vse podrobnosti o dejavnostih ugotavljanja skladnosti, modul ali module za ugotavljanje skladnosti in zadevni proizvod ali proizvode ter ustrezno potrdilo o usposobljenosti.
Where a notification is not based on an accreditation certificate as referred to in Article [R22(2)], the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article [R17].
Če obvestilo ne temelji na certifikatu o akreditaciji iz člena [R22(2)], mora priglasitveni organ Komisiji in drugim državam članicam priskrbeti dokumentirane dokaze, ki potrjujejo kompetence organa za ugotavljanje skladnosti, in vpeljane ukrepe, ki zagotavljajo, da bo organ pod rednim nadzorom in bo izpolnjeval zahteve, določene v členu [R17].
The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Zadevni organ lahko izvaja dejavnosti priglašenega organa le, če Komisija in druge države članice ne vložijo ugovora v dveh tednih od priglasitve v primeru uporabe certifikata o akreditaciji in v dveh mesecih od priglasitve, kadar ni uporabljena akreditacija.
Only such a body shall be considered a notified body for the purposes of this ... [act].
Samo tak organ se šteje za priglašeni organ za namene tega … [akt].
The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification.
Komisija in druga države članice so obveščene o kakršnih koli nadaljnjih zadevnih spremembah priglasitve.
Article R24
Člen R24
Identification numbers and lists of notified bodies
Identifikacijske številke in seznami priglašenih organov
The Commission shall assign an identification number to a notified body.
Komisija dodeli priglašenemu organu identifikacijsko številko.
It shall assign a single such number even where the body is notified under several Community acts.
Dodeli samo eno takšno številko, četudi je organ priglašen v skladu z različnimi akti zakonodaje Skupnosti.
The Commission shall make publicly available the list of the bodies notified under this ... [act], including the identification numbers that have been allocated to them and the activities for which they have been notified.
Komisija javno objavi seznam organov, priglašenih po tem … [akt], vključno z identifikacijskimi številkami, ki so jim bile dodeljene, in dejavnostmi, za katere so bili priglašeni.
The Commission shall ensure that that list is kept up to date.
Komisija zagotovi redno posodabljanje tega seznama.
Article R25
Člen R25
Changes to notifications
Spremembe priglasitve
Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article [R17], or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations.
Če priglasitveni organ ugotovi ali je obveščen, da priglašeni organ ne izpolnjuje več zahtev iz člena [R17] ali da ne more izpolniti svojih obveznosti, priglasitveni organ omeji, razveljavi ali prekliče priglasitev, če je to primerno, v skladu z resnostjo neizpolnjevanja zahtev ali nespoštovanja dolžnosti.
It shall immediately inform the Commission and the other Member States accordingly.
O tem nemudoma obvesti Komisijo in druge države članice.
In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.
V primeru omejitve, razveljavitve ali preklica priglasitve ali če je priglašeni organ prenehal z dejavnostjo, država članica, ki priglašuje, sprejme ustrezne ukrepe za zagotovitev, da gradiva in dokumente tega organa bodisi obdela drug priglašeni organ ali da so na zahtevo na voljo organom, ki priglašujejo in nadzirajo trg.
Article R26
Člen R26
Challenge of the competence of notified bodies
Spodbijanje pristojnosti priglašenih organov
The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.
Komisija mora preiskati vse primere, pri katerih obstaja dvom ali pri katerih je bila opozorjena na dvom glede usposobljenosti priglašenega organa ali glede stalnega izpolnjevanja zahtev in odgovornosti priglašenega organa.
The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the body concerned.
Država članica, ki priglašuje, na zahtevo posreduje Komisiji vse informacije, ki se nanašajo na osnovo za priglasitev ali vzdrževanje pristojnosti zadevnega organa.
The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.
Komisija zagotovi, da so vse informacije občutljive narave, pridobljene med njeno preiskavo, obravnavane zaupno.
Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including de-notification if necessary.
Če Komisija ugotovi, da priglašeni organ ne izpolnjuje ali ne izpolnjuje več zahtev za priglasitev, o tem obvesti državo članico, ki priglašuje, in od nje zahteva, da po potrebi sprejme korektivne ukrepe, vključno z preklicem priglasitve.
Article R27
Člen R27
Operational obligations of notified bodies
Operativne obveznosti priglašenih organov
Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in … [the relevant part of the legislation].
Priglašeni organi morajo izvajati ocenjevanja skladnosti v skladu z veljavnimi postopki za ugotavljanje skladnosti, ki so določeni v … [sklicevanje na ustrezni del zakonodaje].
Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators.
Ocenjevanje skladnosti se izvede sorazmerno tako, da se izogne nepotrebni obremenitvi gospodarskih subjektov.
Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
Organi za ugotavljanje skladnosti pri izvajanju svojih postopkov upoštevajo velikost podjetja, sektor, v katerem deluje in njegovo strukturo, stopnjo zahtevnosti zadevne tehnologije ter masovno ali serijsko naravo proizvodnega postopka.
In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the product with the provisions of this ... [act].
Pri tem morajo kljub temu spoštovati raven strogosti in zaščite, potrebno za skladnost proizvoda glede na določbe tega … [akt].
Where a notified body finds that requirements laid down in … [the relevant part of the legislation] or corresponding harmonised standards or technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a conformity certificate.
Če priglašeni organ ugotovi, da proizvajalec ni izpolnil zahtev, določenih v … [ustrezni del zakonodaje] ali ustreznih harmoniziranih standardih ali tehničnih specifikacijah, mora od proizvajalca zahtevati, da sprejme ustrezne korektivne ukrepe, in ne sme izdati certifikata o skladnosti.
Where, in the course of the monitoring of conformity following the issue of a certificate, a notified body finds that a product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary.
Če med spremljanjem skladnosti po izdaji certifikata priglašeni organ ugotovi, da proizvod ni več skladen, mora od proizvajalca zahtevati, da izvede ustrezne korektivne ukrepe, in po potrebi razveljaviti ali preklicati certifikat.
Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates, as appropriate.
Če korektivni ukrepi niso izvedeni ali nimajo zahtevanega učinka, mora priglašeni organ omejiti, razveljaviti ali preklicati kakršne koli certifikate, če je to primerno.
Article R28
Člen R28
Information obligation on notified bodies
Obveznost informiranja za priglašene organe
Notified bodies shall inform the notifying authority of the following:
Priglašeni organi morajo obvestiti priglasitveni organ o:
any refusal, restriction, suspension or withdrawal of a certificate;
vsaki zavrnitvi, omejitvi, razveljavitvi ali preklicu certifikatov;
any circumstances affecting the scope of and conditions for notification;
okoliščinah, ki vplivajo na področje uporabe priglasitve in pogoje za priglasitev;
any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
katerem koli zahtevku o informacijah v zvezi z opravljenimi dejavnostmi na področju ugotavljanja skladnosti, ki so jih prejeli od organov za nadzor trga;
on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
dejavnostih ugotavljanja skladnosti, izvedenih v okviru njihove priglasitve in o kakršnih koli drugih izvedenih dejavnostih, vključno s čezmejnimi dejavnostmi in sklepanjem pogodb s podizvajalci (na zahtevo priglasitvenega organa).
Notified bodies shall provide the other bodies notified under this ... [act] carrying out similar conformity assessment activities covering the same products with relevant information on issues relating to negative and, on request, positive conformity assessment results.
Priglašeni organi drugim organom, ki so priglašeni v okviru tega … [akt] ter ki izvajajo podobne dejavnosti ugotavljanja skladnosti in zajemajo enake proizvode, zagotavljajo pomembne informacije o zadevah v zvezi s pozitivnimi ali negativnimi rezultati ugotavljanja skladnosti.
Article R29
Člen R29
The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.
Komisija zagotovi izmenjavo izkušenj med nacionalnimi organi držav članic, ki so pristojni za politiko glede priglasitev.
Article R30
Člen R30
Coordination of notified bodies
Usklajevanje priglašenih organov
The Commission shall ensure that appropriate coordination and cooperation between bodies notified under … [the relevant act or other Community legislation] are put in place and properly operated in the form of a … [sectoral or cross sectoral] group or groups of notified bodies.
Komisija zagotovi ustrezno usklajevanje in sodelovanje med organi, ki so bili priglašeni v okviru … [sklicevanje na zadevni del zakonodaje Skupnosti] ter pravilno delovanje v obliki ... [sektorskih ali medsektorskih] skupin priglašenih organov.
Member States shall ensure that the bodies notified by them participate in the work of that or those group or groups, directly or by means of designated representatives.
Države članice zagotovijo, da organi, ki jih priglasijo, sodelujejo pri delu navedenih skupin, neposredno ali s pooblaščenimi zastopniki.
Chapter R5
Poglavje R5
Safeguard procedures
Zaščitni postopki
Article R31
Člen R31
Procedure for dealing with products presenting a risk at national level
Postopek za obravnavo tveganih proizvodov na nacionalni ravni
Where the market surveillance authorities of one Member State have taken action pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have sufficient reason to believe that a product covered by this ... [act] presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this ... [act], they shall carry out an evaluation in relation to the product concerned covering all the requirements laid down in this ... [act].
Če so organi za nadzor trga ene države članice ukrepali v skladu s členom 20 Uredbe (ES) št. 765/2008 ali če utemeljeno menijo, da proizvod, ki ga vključuje ta … [akt], ogroža zdravje, varnost oseb ali druge vidike zaščite javnega interesa, ki so določeni v tem … [akt], izvedejo vrednotenje zadevnega proizvoda glede izpolnjevanja vseh zahtev, ki so določene s tem … [akt].
The relevant economic operators shall cooperate as necessary with the market surveillance authorities.
Zadevni gospodarski subjekti morajo zagotoviti vse potrebno za sodelovanje z organi za nadzor trga.
Where, in the course of that evaluation, the market surveillance authorities find that the product does not comply with the requirements laid down in this ... [act], they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the product into compliance with those requirements, to withdraw the product from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.
Če med vrednotenjem organi za nadzor trga ugotovijo, da proizvod ne izpolnjuje zahtev, ki jih določa ta … [akt], od zadevnega gospodarskega subjekta nemudoma zahtevajo, da izvede vse ustrezne korektivne ukrepe, da proizvod izpolni te zahteve, ali pa proizvod umaknejo s trga ali ga odpokličejo v roku, ki je določen glede na stopnjo tveganja.
The market surveillance authorities shall inform the relevant notified body accordingly.
Organi za nadzor trga o tem obvestijo ustrezni priglašeni organ.
Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph.
Za ukrepe iz drugega pododstavka 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.
Če organi za nadzor trga menijo, da neizpolnjevanje presega nacionalno ozemlje, Komisijo in druge države članice obvestijo o rezultatih vrednotenja in o ukrepih, ki jih zahtevajo od gospodarskega subjekta.
The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Community.
Gospodarski subjekt zagotavlja izvajanje vseh primernih korektivnih ukrepov glede proizvoda, ki ga je dal na trg po vsej Skupnosti.
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 product's being made available on their national market, to withdraw the product from that market or to recall it.
Če gospodarski subjekt v roku iz drugega pododstavka odstavka 1 ne sprejme korektivnih ukrepov, organi za nadzor trga sprejmejo ustrezne začasne ukrepe za prepoved ali omejevanje proizvoda na nacionalnem trgu ali pa ga umaknejo ali odpokličejo s trga.
They shall inform the Commission and the other Member States, without delay, of those measures.
Komisijo in druge države članice nemudoma obvestijo o takih ukrepih.
The information referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, 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 odstavka 4 morajo vsebovati vse natančne podatke, še zlasti podatke, potrebne za določanje neskladnega proizvoda, poreklo proizvoda, vrsto domnevne neskladnosti in tveganja ter vrsto in trajanje izvajanih nacionalnih ukrepov kakor tudi stališče zadevnega gospodarskega subjekta.
In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either:
Zlasti organi za nadzor trga navedejo, ali je do neizpolnjevanja prišlo iz naslednjih vzrokov:
failure of the product to meet requirements relating to the health or safety of persons or to other aspects of public interest protection laid down in this ... [act]; or
proizvod ne izpolnjuje pogojev, ki so povezani z ogrožanjem zdravja ali varnosti ali drugimi vidiki zaščite javnega interesa in so določeni v tem … [akt];
shortcomings in the harmonised standards referred to in … [reference to the relevant part of the legislation] conferring a presumption of conformity.
pomanjkljivosti pri harmoniziranih standardih iz [sklicevanje na zadevni del zakonodaje] kot je domneva o skladnosti.
Member States other than the Member State initiating the procedure 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 product concerned, and, in the event of disagreement with the notified national measure, of their objections.
Države članice, ki niso tiste, ki so začele postopek, morajo nemudoma obvestiti Komisijo in ostale države članice o vseh sprejetih ukrepih in ostalih informacijah, ki se nanašajo na neskladnost zadevnega proizvoda; v primeru nestrinjanja s priglašenim nacionalnim ukrepom pa morajo predložiti svoje razloge.
Where, within …. [period to be specified] of receipt of the information referred to in 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.
Če v obdobju … [navesti obdobje] po prejemu informacij iz odstavka 4 ni vložen noben ugovor s strani države članice ali Komisije glede začasnega ukrepa, ki ga je sprejela država članica, se šteje, da je ukrep upravičen.
Member States shall ensure that appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from their market, without delay.
Države članice morajo zagotoviti takojšnje izvajanje ustreznih restriktivnih ukrepov v zvezi z zadevnim proizvodom, na primer umik proizvoda s tržišča.
Article R32
Člen R32
Community safeguard procedure
Zaščitni postopek Skupnosti
Where, on completion of the procedure set out in Article [R31(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 Community 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.
Če so glede izvajanja postopka iz člena [R31(3) in (4)] vloženi ugovori zoper nacionalni ukrep države članice ali če Komisija meni, da je ukrep v nasprotju z zakonodajo Skupnosti, Komisija nemudoma začne posvetovanje z državami članicami in ustreznim(-i) gospodarskim(-i) subjektom(-i) ter nadaljuje z oceno nacionalnega ukrepa.
On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not.
Na podlagi izidov te ocene Komisija odloči, ali je nacionalni ukrep upravičen ali ne.
The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.
Komisija sklep naslovi na vse države članice in jim ga nemudoma posreduje, prav tako tudi zadevnim(-emu) gospodarskim(-emu) subjektom(-u).
If the national measure is considered justified, all Member States shall take the measures necessary to ensure that the non-compliant product is withdrawn from their market, and shall inform the Commission accordingly.
Če se nacionalni ukrep ne šteje kot upravičen, vse države članice sprejmejo potrebne ukrepe za zagotovitev, da se neskladni proizvod umakne z njihovih trgov, in o tem obvestijo Komisijo.
If the national measure is considered unjustified, the Member State concerned shall withdraw the measure.
Če se nacionalni ukrep šteje kot neupravičen, zadevna država članica prekliče ukrep.