natgillin/translations-raw huggingface dataset:
Following a request from the EFTA States by intermediary of the EFTA Secretariat dated 14 April 2014, the Authority amended and prepared draft amended RAPEX Guidelines to reflect the new procedure and foreseen future validator tasks of the national RAPEX contact points of the EEA EFTA States, as outlined and described in greater detail in Appendix 6 to the draft amended RAPEX Guidelines.
Na zahtevo držav Efte prek posrednika Sekretariata Efte z dne 14. aprila 2014 je Nadzorni organ spremenil in pripravil osnutek spremenjenih smernic RAPEX, v katerih je vključen novi postopek in predvidene prihodnje naloge preverjanja za nacionalne kontaktne točke RAPEX držav EGP-Efte, kakor so pojasnjene in podrobno opisane v Dodatku 6 osnutka spremenjenih smernic RAPEX.
In accordance with the written procedure provided for in Article 8 of its rules of procedure, the Committee was consulted on the draft amended RAPEX Guidelines [6].The RAPEX Guidelines should be addressed to the national authorities of the EFTA States designated as contact points in the RAPEX system, and in charge of the notification procedures under Article 11 of Directive 2001/95/EC.
V skladu s pisnim postopkom iz člena 8 njegovega poslovnika so bila z odborom opravljena posvetovanja o osnutku spremenjenih smernic RAPEX [6].Smernice RAPEX bi morale biti naslovljene na nacionalne organe držav Efte, ki so določeni kot kontaktne točke v sistemu RAPEX in pristojni za postopke obveščanja iz člena 11 Direktive 2001/95/ES.
The Authority will use the RAPEX Guidelines as the reference document for managing RAPEX and the notification procedure under Directive 2001/95/EC,
Nadzorni organ bo uporabljal smernice RAPEX kot referenčni dokument za upravljanje sistema RAPEX in postopek obveščanja iz Direktive 2001/95/ES –
After having consulted the EFTA Committee on Technical Regulations, Standards, Testing and Certification on the matter, the Authority hereby adopts amended guidelines to supplement the Act referred to at point 3h of Chapter XIX of Annex II to the Agreement on the European Economic Area for the management of the Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of the Act.
Nadzorni organ po posvetovanju o zadevi z Odborom Efte za tehnične predpise, standarde, preskušanje in certificiranje sprejme spremenjene smernice za dopolnitev akta, navedenega v točki 3h poglavja XIX Priloge II k Sporazumu o Evropskem gospodarskem prostoru za upravljanje sistema hitre izmenjave informacij „RAPEX“ iz člena 12 in postopka obveščanja iz člena 11 akta.
The Decision, including the amended guidelines set out in the Annex, shall be published in the EEA Section of, and the EEA Supplement to, the Official Journal of the European Union.
Ta odločba se skupaj s spremenjenimi smernicami iz Priloge objavi v sklopu EGP Uradnega lista Evropske unije in Dopolnilu EGP k Uradnemu listu Evropske unije.
This Decision is addressed to the EFTA States.
Ta odločba je naslovljena na države Efte.
The EFTA Committee on Technical Regulations, Standards, Testing and Certification, as designated by Decision No 4/2012/SC of the Standing Committee of the EFTA States of 26 October 2012.
Odbor Efte za tehnične predpise, standarde, preskušanje in certificiranje, kakor je bil določen s Sklepom Stalnega odbora držav Efte št. 4/2012/SC z dne 26. oktobra 2012.
Commission Decision 2010/15/EU of 16 December 2009 laying down guidelines for the management of the Community Rapid Information System RAPEX established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive) (OJ L 22, 26.1.2010, p.
Sklep Komisije 2010/15/EU z dne 16. decembra 2009 o smernicah za upravljanje hitrega informacijskega sistema Skupnosti (RAPEX) iz člena 12 in postopka obveščanja iz člena 11 Direktive 2001/95/ES (Direktiva o splošni varnosti proizvodov) (UL L 22, 26.1.2010, str.
Commission Decision 2004/418/EC of 29 April 2004 laying down guidelines for the management of the Community Rapid Information System (RAPEX) and for notifications presented in accordance with Article 11 of Directive 2001/95/EC (OJ L 151, 30.4.2004, p.
Odločba Komisije 2004/418/ES z dne 29. aprila 2004 o določitvi smernic za upravljanje hitrega informacijskega sistema Skupnosti (RAPEX) in za uradna obvestila, predstavljena v skladu s členom 11 Direktive 2001/95/ES (UL L 151, 30.4.2004, str.
83).
83).
See letters of 8 July 2014 (Events No 714776, 714853, and 714857).
Glej dopise z dne 8. julija 2014 (ev. št. 714776, 714853 in 714857).
EFTA Surveillance Authority Guidelines for the management of the Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive)
Smernice Nadzornega organa Efte za upravljanje sistema hitre izmenjave informacij „RAPEX“ iz člena 12 in postopka obveščanja iz člena 11 Direktive 2001/95/ES (Direktiva o splošni varnosti proizvodov)
Status and addresses of the guidelines
Status in naslovniki smernic
Rapid information system ‘RAPEX’ established under Article 12 of the General Product Safety Directive
Sistem hitre izmenjave informacij „RAPEX“ iz člena 12 Direktive o splošni varnosti proizvodov
Notifying authorities
Organi, ki obveščajo
RAPEX notification concerning business notifications
Obveščanje RAPEX glede prijav podjetij
Risk assessment in business notifications
Ocena tveganja pri prijavah podjetij
Handling of notifications covered by confidentiality
Obravnavanje zaupnih obvestil
Examination of notifications by the EFTA Surveillance Authority
Pregled obvestil s strani Nadzornega organa Efte
Validation of notifications on safety aspects subject to discussions at EEA level
Preverjanje obvestil o varnostnih vidikih, ki so predmet razprave na ravni EGP
Permanent withdrawal of a notification by EEA States from the RAPEX application
Trajni umik obvestila s strani držav EGP iz aplikacije RAPEX
Examination of reactions from EFTA States by the EFTA Surveillance Authority
Pregled odzivov iz držav Efte s strani Nadzornega organa Efte
RAPEX networks established at EEA and national levels
Mreže RAPEX, vzpostavljene na ravni EGP in nacionalnih ravneh
RAPEX contact points Network
Mreža kontaktnih točk RAPEX
Notification procedure established under Article 11 of the General Product Safety Directive
Postopek obveščanja iz člena 11 Direktive o splošni varnosti proizvodov
Tasks and role of the national RAPEX contact points of the EFTA States
Naloge in vloga nacionalnih kontaktnih točk RAPEX držav Efte
The revised General Product Safety Directive, as adapted to the Agreement on European Economic Area by Protocol 1 thereto, entered into force in the EFTA States on 1 March 2004.
Revidirana Direktiva o splošni varnosti proizvodov, kakor je prilagojena Sporazumu EGP s Protokolom 1 k Sporazumu, je v državah Efte začela veljati 1. marca 2004.
By its Decision 2010/15/EU, the Commission adopted new guidelines, thereby repealing Decision 2004/418/EC.
Komisija je s Sklepom 2010/15/EU sprejela nove smernice in s tem razveljavila Odločbo 2004/418/ES.
According to Article 5(2)(d) of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice, the EFTA Surveillance Authority (referred to also as ‘ESA’ or ‘the Authority’ in these guidelines) shall carry out the functions which, through the application of Protocol 1 to the EEA Agreement, follow from the acts referred to in the Annexes to that Agreement, as specified in Protocol 1 to the Surveillance and Court Agreement.
Nadzorni organ Efte zato meni, da je treba sprejeti in objaviti smernice, ki ustrezajo novim smernicam Komisije in služijo podobnemu namenu.
Furthermore, pursuant to Article 1(2) of Protocol 1 to the Surveillance and Court Agreement, the EFTA Surveillance Authority shall carry out certain functions corresponding to the functions of the European Commission.
Te smernice so naslovljene na nacionalne organe držav Efte, ki so določeni kot kontaktne točke v sistemu RAPEX in so pristojni za postopke obveščanja iz člena 11 Direktive 2001/95/ES.
The EFTA Surveillance Authority therefore considers it necessary to adopt and issue guidelines equivalent to, and serving a similar purpose as, the new Commission guidelines.
Nadzorni organ Efte uporablja te smernice kot referenčni dokument pri delovanju RAPEX in postopku obveščanja iz člena 11.
These guidelines are addressed to the national authorities in the EFTA States designated as contact points in the RAPEX and in charge of the notification procedure under Article 11 of Directive 2001/95/EC.
Treba je opozoriti, da v teh smernicah izraz „države Efte“ pomeni „države Efte – pogodbenice Sporazuma EGP, za katere je Sporazum začel veljati“.
The EFTA Surveillance Authority shall use these guidelines as the reference document in operating RAPEX and the Article 11 notification procedure.
Poleg tega v teh smernicah izraz „države EGP“ pomeni vse države, ki so članice Evropske unije, in tiste države Efte, ki so pogodbenice Sporazuma EGP.
It should be noted that in these guidelines, the term ‘EFTA States’ shall read ‘EFTA States contracting parties to the EEA Agreement in respect of which the Agreement has entered into force’.
Nadzorni organ Efte lahko te smernice po potrebi spremeni ali dopolni ali jih uskladi s smernicami, ki jih izda Komisija.
Also, in the context of these guidelines, the term ‘EEA States’ shall mean all States which belong to the European Union and those EFTA States which are contracting parties to the EEA Agreement.
Te smernice ter njihove prihodnje spremembe in dopolnitve bodo objavljene v sklopu EGP Uradnega lista Evropske unije in njegovemu Dopolnilu EGP v skladu z dogovorom o objavljanju informacij, pomembnih za EGP, iz Sklepne listine k Sporazumu EGP.
These guidelines may be amended or supplemented by the EFTA Surveillance Authority where necessary or to accord with the guidelines issued by the Commission.
DEL I
These guidelines and future amendments and additions thereto will be published in the EEA Section of the Official Journal of the European Union and the EEA Supplement thereto in accordance with the Arrangement with regard to Publication of EEA Relevant Information, referred to in the Final Act of the EEA Agreement.
Status in naslovniki smernic
PART I
STATUS, CILJI IN POSODABLJANJE SMERNIC
Status and addressees of the Guidelines
Nadzorni organ Efte sprejme „Smernice za upravljanje sistema hitre izmenjave informacij ‚RAPEX‘ iz člena 12 in postopka obveščanja iz člena 11 Direktive 2001/95/ES (Direktiva o splošni varnosti proizvodov)“ (v nadaljnjem besedilu: smernice) v skladu s členom 11(1) in točko 8 Priloge II akta, navedenega v točki 3h poglavja XIX Priloge II k Sporazumu o Evropskem gospodarskem prostoru, in sicer Direktive 2001/95/ES (v nadaljnjem besedilu: GPSD), kakor sta prilagojena Sporazumu EGP s Protokolom 1 k Sporazumu.
STATUS, OBJECTIVES AND UPDATING OF THE GUIDELINES
Pri opravljanju te naloge Nadzornemu organu pomaga svetovalni odbor, ki ga sestavljajo predstavniki držav Efte in deluje v skladu s svetovalnim postopkom [1].Iz točke 8 priloge II GPSD sledi, da Nadzorni organ Efte pripravi in redno posodablja, v skladu z veljavnim svetovalnim postopkom, smernice o upravljanju RAPEX s strani Nadzornega organa Efte in držav Efte.
The ‘Guidelines for the management of the Rapid Information System “RAPEX” established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive)’ (the ‘Guidelines’) are adopted by the EFTA Surveillance Authority pursuant to Article 11(1) and Annex II, point 8, to the Act referred to at point 3h of Chapter XIX of Annex II to the Agreement on the European Economic Area, Directive 2001/95/EC, as adapted to the EEA Agreement by Protocol 1 thereto.
Poleg tega člen 11(1) GPSD navaja, da morajo smernice, pripravljene za namen postopka obveščanja RAPEX, urejati tudi različne vidike postopka obveščanja iz člena 11 GPSD.
In carrying out this task, the Authority is assisted by an advisory committee composed of the representatives of the EFTA States acting in accordance with the advisory procedure [1].It follows from point 8 of Annex II to the GPSD that the EFTA Surveillance Authority shall prepare and regularly update, in accordance with the applicable advisory procedure, guidelines concerning the management of RAPEX by the EFTA Surveillance Authority and the EFTA States.
Smernice torej urejajo delovanje in upravljanje postopka obveščanja RAPEX iz člena 12 GPSD in postopka obveščanja iz člena 11 GPSD.
Furthermore, Article 11(1) of the GPSD states that the guidelines drafted for the purpose of the RAPEX notification procedure should also regulate various aspects of the notification procedure established under Article 11 of the GPSD.
Smernice so samostojen dokument, ki ureja postopek obveščanja RAPEX iz člena 12 GPSD.
Therefore, the Guidelines regulate the operation and management of the RAPEX notification procedure established under Article 12 of the GPSD, as well as the notification procedure established under Article 11 of the GPSD.
Ta postopek velja za preprečevalne in omejevalne ukrepe v zvezi s proizvodi za potrošnike, ki predstavljajo resno tveganje za zdravje in varnost potrošnikov.
The Guidelines form a self-standing document that governs the RAPEX notification procedure established under Article 12 of the GPSD.
Vendar struktura in vsebina smernic omogočata njihovo prilagajanje, če je to primerno, z vključevanjem določb v zvezi s postopkom obveščanja v skladu s členom 22 Uredbe (ES) št. 765/2008 Evropskega parlamenta in Sveta [2].Države EGP, države prosilke, pa tudi tretje države in mednarodne organizacije, ki imajo omogočen dostop do RAPEX (pod pogoji iz člena 12(4) GPSD), sodelujejo v sistemu v skladu s pravili iz GPSD in smernic.
This procedure applies to preventive and restrictive measures taken in relation to consumer products posing a serious risk to the health and safety of consumers.
GPSD določa oblikovanje smernic za določitev preprostih in jasnih meril ter praktičnih pravil za olajšanje delovanja mehanizma obveščanja v skladu s členoma 11 in 12 GPSD.
However, the structure and content of the Guidelines allow them to be adapted, if appropriate, to include provisions relating to the notification procedure established under Article 22 of Regulation (EC) No 765/2008 of the European Parliament and of the Council [2].EEA States, applicant countries, as well as third countries and international organisations which are granted access to RAPEX (on the conditions defined in Article 12(4) of the GPSD), participate in the system according to the rules provided for in the GPSD and the Guidelines.
Cilji smernic so:
The GPSD provides for the establishment of guidelines to lay down simple and clear criteria and practical rules to facilitate the operation of the notification mechanisms established under Articles 11 and 12 of the GPSD.
razjasniti področje uporabe dveh mehanizmov obveščanja,
The objectives of the Guidelines are to:
določiti merila obveščanja za oba mehanizma obveščanja,
clarify the scope of the two notification mechanisms,
opredeliti vsebino obvestil in odzive, poslane po obeh mehanizmih obveščanja, zlasti zahtevane podatke in obrazce, ki jih je treba uporabiti,
set out the notification criteria for the two notification mechanisms,
določiti nadaljnje ukrepe, ki jih sprejmejo države Efte ob prejemu obvestila, in vrsto informacij, ki jih je treba predložiti,
define the content of notifications and reactions sent under the two notification mechanisms, in particular what data are required and forms to be used,
opisati, kako Komisija obravnava obvestila in odzive Komisije,
establish follow-up action to be taken by EFTA States upon receipt of a notification and the type of information to be provided,
določiti roke za različne vrste ukrepov, sprejetih v skladu z obema mehanizmoma obveščanja,
describe the handling of notifications and reactions by the EFTA Surveillance Authority,
določiti potrebne praktične in tehnične dogovore na ravni Nadzornega organa Efte in držav Efte za uspešno in učinkovito delovanje mehanizmov obveščanja,
set deadlines for the various types of action taken under the two notification mechanisms,
vzpostaviti metodo ocenjevanja tveganja in zlasti merila za ugotavljanje resnih tveganj.
set out the practical and technical arrangements needed at the level of the EFTA Surveillance Authority and the EFTA States for the notification mechanisms to be employed effectively and efficiently,
Nadzorni organ Efte bo redno posodabljal smernice v skladu s posodobitvami, ki jih sprejme Komisija z vidika izkušenj in razvoja na področju varnosti proizvodov ter v skladu s svetovalnim postopkom iz točke 1.1.
establish a risk assessment method and, in particular, criteria for identifying serious risks.
NASLOVNIKI SMERNIC
The Guidelines will be regularly updated by the EFTA Surveillance Authority in accordance with the updates adopted by the Commission in the light of experience and new developments in the product safety area and in accordance with the advisory procedure referred to in point 1.1.
Smernice so naslovljene na vse organe držav Efte, ki delujejo na področju varnosti proizvodov za potrošnike in sodelujejo v mreži RAPEX, vključno z organi za nadzor trga, odgovornimi za spremljanje skladnosti proizvodov za potrošnike z varnostnimi zahtevami, in organi, pristojnimi za nadzor zunanjih meja.
ADDRESSEES OF THE GUIDELINES
Nadzorni organ Efte bi moral v sodelovanju s Komisijo uporabljati smernice kot referenčni dokument za upravljanje sistema RAPEX iz člena 12 GPSD in postopka obveščanja iz člena 11 GPSD.
The Guidelines are addressed to all the authorities of the EFTA States acting in the consumer product safety area and participating in the RAPEX network, including market surveillance authorities responsible for monitoring the compliance of consumer products with safety requirements, and authorities in charge of external border controls.
DEL II
The EFTA Surveillance Authority should use the Guidelines as a reference for managing, in cooperation with the Commission, the RAPEX system established under Article 12 of the GPSD and the notification procedure under Article 11 of the GPSD.
UVOD
PART II
Člen 12 GPSD vzpostavlja sistem hitre izmenjave informacij (v nadaljnjem besedilu: RAPEX).
INTRODUCTION
RAPEX je bil vzpostavljen zato, da:
Article 12 of the GPSD establishes a Rapid Information System (‘RAPEX’).
zagotavlja mehanizem za hitro izmenjavo informacij med državami EGP, Komisijo in Nadzornim organom Efte o preprečevalnih in omejevalnih ukrepih, sprejetih v zvezi s proizvodi za potrošnike, ki predstavljajo resno tveganje za zdravje in varnost potrošnikov,
RAPEX was established in order to:
obvešča države EGP, Komisijo in Nadzorni organ Efte o sklepih glede nadaljnjega ukrepanja nacionalnih organov v zvezi z informacijami, izmenjanimi prek RAPEX.
provide a rapid information exchange mechanism between the EEA States, the Commission and the EFTA Surveillance Authority on preventive and restrictive measures taken in relation to consumer products posing a serious risk to the health and safety of consumers,
RAPEX ima pomembno vlogo na področju varnosti proizvodov, dopolnjuje druge ukrepe na nacionalni in evropski ravni ter s tem zagotavlja visoko raven varstva potrošnikov v EGP.
inform the EEA States, the Commission and the EFTA Surveillance Authority of the conclusions of follow-up action taken by national authorities with regard to information exchanged through RAPEX.
Podatki RAPEX pomagajo pri:
RAPEX plays an important role in the area of product safety; it complements other action taken both at national and at European level to ensure a high level of consumer safety in the EEA.
preprečevanju in omejevanju dobave nevarnih proizvodov potrošnikom,
RAPEX data help to:
spremljanju učinkovitosti in doslednosti nadzora trga ter dejavnostih izvrševanja organov držav EGP,
prevent and restrict the supply to consumers of dangerous products,
ugotavljanju potreb in ustvarjanju podlage za ukrepanje na ravni EGP,
monitor the effectiveness and consistency of market surveillance and enforcement activities carried out by EEA States' authorities,
zagotavljanju doslednega uveljavljanja zahtev EGP glede varnosti proizvodov in nemotenega delovanja notranjega trga.
identify needs and provide a basis for action at EEA level,
RAPEX je sestavljen iz več dopolnilnih komponent, ki so bistvenega pomena za učinkovito delovanje.
make for consistent enforcement of the EEA product safety requirements and thus the smooth functioning of the Internal Market.
Najpomembnejše so:
RAPEX consists of several complementary components, which are crucial for effective and efficient operation.
pravni okvir, ki ureja delovanje sistema (tj. GPSD in smernice),
The most important are:
spletna prijava (aplikacija RAPEX), ki omogoča državam EGP, Komisiji in Nadzornemu organu Efte hitro izmenjavo informacij prek spleta,
the legal framework, which regulates how the system operates (i.e. the GPSD and the Guidelines),
mreža kontaktnih točk RAPEX, ki jo sestavljajo posamezne kontaktne točke RAPEX vseh držav EGP, ki so odgovorne za delovanje RAPEX,
the online application (‘RAPEX application’), which allows EEA States, the Commission and the EFTA Surveillance Authority to exchange information rapidly via a web-based platform,
nacionalne mreže RAPEX, vzpostavljene v vseh državah EGP, ki vključujejo kontaktne točke RAPEX in vse organe, ki so vključeni v zagotavljanje varnih proizvodov za potrošnike,
the RAPEX contact points network, which consists of the single RAPEX contact points responsible for operating RAPEX in all the EEA States,
skupina RAPEX pri Komisiji v oddelku, odgovornem za GPSD, ki pregleduje in preverja dokumente, ki jih prek RAPEX predložijo države članice EU, ter vzdržuje in zagotavlja pravilno delovanje sistema RAPEX v zvezi s temi državami,
the national RAPEX networks established in all EEA States, which include the RAPEX contact points and all the authorities involved in ensuring consumer product safety,
skupina RAPEX pri Nadzornem organu Efte, ki pregleduje dokumente, ki jih predložijo države Efte, preden jih države Efte preverijo v bazi podatkov RAPEX, da bi jih posredovale Komisiji, ter ki vzdržuje in zagotavlja pravilno delovanje sistema RAPEX v zvezi s temi državami,
the Commission RAPEX Team in the department responsible for the GPSD, which examines and validates documents submitted through RAPEX by EU Member States, and maintains and ensures correct operation of the RAPEX system with regard to these states,
spletišče RAPEX [3], ki vsebuje povzetke obvestil RAPEX na podlagi člena 16(1) GPSD;
the EFTA Surveillance Authority's RAPEX Team which examines documents submitted by EFTA States, prior to the validation by the EFTA States thereof in the RAPEX database, in view of transmission to the Commission, and which maintains and ensures correct operation of the RAPEX system with regard to these States,
objave RAPEX, kot so statistični podatki RAPEX, letna poročila RAPEX in drugo promocijsko gradivo.
the RAPEX website [3], which provides summaries of RAPEX notifications in application of Article 16(1) of the GPSD,
MERILA ZA OBVEŠČANJE PREK SISTEMA RAPEX
RAPEX publications, such as RAPEX statistics, RAPEX annual reports and other promotional materials.
RAPEX, ki ga vzpostavlja člen 12 GPSD, se uporablja za ukrepe, ki preprečujejo, omejujejo ali uveljavljajo posebne pogoje za trženje in uporabo proizvodov za potrošnike, ki predstavljajo resno tveganje za zdravje in varnost potrošnikov.
RAPEX NOTIFICATION CRITERIA
V skladu z GPSD je sodelovanje držav Efte v RAPEX obvezno, zato imajo države Efte pravno obveznost, da Nadzorni organ Efte obvestijo, ko so izpolnjena naslednja štiri merila za obveščanje:
RAPEX, which is established under Article 12 of the GPSD, applies to measures which prevent, restrict or impose specific conditions on the marketing and use of consumer products posing a serious risk to the health and safety of consumers.
proizvod je proizvod za potrošnike,