natgillin/translations-raw huggingface dataset:
Under the GPSD, the participation of the EFTA States in RAPEX is mandatory, and thus the EFTA States have a legal obligation to notify the EFTA Surveillance Authority when the following four notification criteria are met:
za proizvod veljajo ukrepi za preprečevanje, omejitev ali uveljavitev posebnih pogojev za morebitno trženje ali uporabo proizvodov („preprečevalni in omejevalni ukrepi“),
the product is a consumer product,
proizvod predstavlja resno tveganje za zdravje in varnost potrošnikov,
the product is subject to measures that prevent, restrict or impose specific conditions on its possible marketing or use (‘preventive and restrictive measures’),
resno tveganje ima čezmejni učinek.
the product poses a serious risk to the health and safety of consumers,
Proizvodi, ki jih RAPEX zajema
the serious risk has a cross-border effect.
V skladu s členom 2(a) GPSD so proizvodi za potrošnike v RAPEX:
Products covered by RAPEX:
„proizvodi, namenjeni potrošnikom“
Under Article 2(a) of the GPSD, consumer products for the purpose of RAPEX are:
proizvodi, zasnovani in izdelani za potrošnike in so dostopni potrošnikom,
‘products intended for consumers’
„proizvodi, ki prehajajo“
products that are designed and manufactured for and made available to consumers,
proizvodi, ki so zasnovani in izdelani za strokovnjake, vendar jih v razumno predvidljivih okoliščinah lahko uporabljajo potrošniki.
‘migrating products’
To so proizvodi, izdelani za strokovnjake in dostopni potrošnikom, ki jih lahko kupijo in upravljajo brez posebnega znanja ali usposabljanja, npr. električni vrtalni stroj, kotni brusilnik in namizna žaga so bili zasnovani in izdelani za strokovnjake, vendar tudi dobavljeni na potrošniški trg (potrošniki jih lahko kupijo v trgovinah in jih sami upravljajo brez posebnega usposabljanja).
products that are designed and manufactured for professionals, which are likely, however, under reasonably foreseeable conditions, to be used by consumers.
Tako proizvodi, namenjeni potrošnikom, kot proizvodi, ki prehajajo, so lahko potrošnikom na voljo brezplačno, lahko jih kupijo, ali pa so jim na voljo v okviru storitve.
These are products manufactured for professionals that are made available to consumers, who can purchase and operate them without any special knowledge or training, e.g. a power drill, an angle grinder and a table saw designed and manufactured for professionals, but also supplied on the consumer market (i.e. consumers can readily purchase them in shops and operate them on their own without any special training).
RAPEX zajema vse tri primere.
Both products intended for consumers and migrating products can be given to consumers free of charge, can be purchased by consumers or can be provided to consumers in the context of a service.
Proizvodi, ki so potrošnikom na voljo v okviru storitve, vključujejo:
All three situations are covered by RAPEX.
proizvode, dobavljene potrošnikom, ki se odnesejo in uporabijo zunaj prostorov ponudnika storitve, kot so avtomobili in kosilnice za travo, ki se najemajo ali izposojajo v izposojevalnicah, ter črnila za tetoviranje in vsadki (ki ne spadajo med medicinske pripomočke), ki jih ponudnik storitve vsadi pod kožo potrošnika,
Products provided to consumers in the context of a service include:
proizvode, ki se uporabijo v prostorih ponudnika storitve, če potrošniki sami aktivno upravljajo proizvod (npr. zagon stroja in možnost njegove ustavitve vplivata na upravljanje stroja s spremembo položaja ali intenzivnosti med uporabo).
products supplied to consumers that are taken away and used outside the premises of a service provider, such as cars and lawn-mowing machines rented or leased in rental salons, and tattoo inks and implants (that are not classified as medical devices) implanted beneath the skin of a consumer by a service provider,
Solariji v salonih za porjavitev in fitnes centri so primeri takšnih proizvodov.
products used on the premises of a service provider, provided that consumers themselves actively operate a product (e.g. start the machine, have the option of stopping it, affect its operation by changing its position or intensity during use).
Uporaba proizvodov s strani potrošnikov mora biti aktivna in mora vključevati visoko raven nadzora.
Sun-beds used in tanning salons and fitness centres are examples of such products.
Zgolj pasivna uporaba, kot je uporaba šampona s strani osebe, ki ji frizer umiva lase, ali uporaba avtobusa s strani potnikov, se ne šteje kot uporaba s strani potrošnikov.
Use of the products by consumers must be active, and involve a significant degree of control.
Nasprotno pa oprema, ki jo uporablja ali z njo upravlja ponudnik storitve za opravljanje storitve, presega področje uporabe sistema RAPEX, zato takšnih proizvodov ni mogoče prijaviti prek sistema, na primer oprema, s katero se potrošniki prevažajo ali potujejo in jo upravlja ponudnik storitve.
Merely passive use, such as the use of shampoo by a person whose hair is washed by a hairdresser, or the use of a bus by its passengers, does not qualify as use by consumers.
Proizvodi, ki jih RAPEX ne zajema
By contrast, equipment used or operated by a service provider to supply a service is beyond the scope of RAPEX and therefore such products cannot be notified through the system, e.g. equipment on which consumers ride or travel which are operated by a service provider.
RAPEX ne zajema:
Products which are not covered by RAPEX:
Proizvodov, ki niso zajeti v opredelitvi „proizvoda“ iz člena 2(a) GPSD:
RAPEX does not cover:
proizvodi, ki so zasnovani in izdelani ter na voljo samo strokovnjakom in za katere ni verjetno, da bi jih, v razumno predvidljivih okoliščinah, uporabljali potrošniki (profesionalni proizvodi),
Products that are not covered by the definition of a ‘product’ laid down in Article 2(a) of the GPSD:
rabljeni proizvodi, dobavljeni kot starine ali kot proizvodi, ki jih je treba pred uporabo popraviti ali ponovno usposobiti, če dobavitelj o tem jasno obvesti osebo, ki ji dobavlja.
second-hand products supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that a supplier clearly informs the person to whom he supplies the product to that effect.
Za vse kategorije preprečevalnih in omejevalnih ukrepov v zvezi s trženjem in uporabo proizvodov za potrošnike, ki predstavljajo resno tveganje za zdravje in varnost potrošnikov, velja obveznost obveščanja v okviru RAPEX.
Products that are covered by specific and equivalent notification mechanisms established by other EEA legislation:
Člen 8(1)(b) do (f) GPSD vsebuje seznam različnih kategorij ukrepov, ki jih je treba prijaviti v skladu s sistemom RAPEX, vključno z ukrepi:
food and feed covered by Regulation (EC) No 178/2002 of the European Parliament and of the Council [4],medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council [5], and Directive 2001/82/EC of the European Parliament and of the Council [6],medical devices covered by Council Directive 93/42/EEC [7],in vitro diagnostic medical devices covered by Directive 98/79/EC of the European Parliament and of the Council [8],active implantable medical devices covered by Council Directive 90/385/EEC [9].2.2.
označiti proizvod z ustreznimi opozorili glede tveganja, ki ga lahko predstavlja,
All categories of preventive and restrictive measures taken in relation to the marketing and use of consumer products posing a serious risk to the health and safety of consumers are subject to the notification obligation under RAPEX.
postaviti pogoje še pred trženjem proizvoda,
Article 8(1)(b) to (f) of the GPSD provides a list of the different categories of measures that are notifiable under RAPEX, including measures:
opozoriti potrošnike na nevarnost, ki bi ga lahko predstavljal proizvod za nekatere osebe,
marking a product with appropriate warnings on the risks it may present,
začasno prepovedati dobavo, ponujanje dobave in razstavljanje proizvoda,
making the marketing of a product subject to prior conditions,
prepovedati trženje proizvoda in vse spremljajoče ukrepe,
warning consumers of the risks that could be posed by a product for certain persons,
umakniti proizvod s trga,
temporary ban on the supply, offer to supply and display of a product,
odpoklicati proizvod od potrošnikov,
ban on the marketing of a product and any accompanying measures,
uničiti umaknjen ali odpoklican proizvod.
withdrawal of a product from the market,
V RAPEX se izraz „umik“ uporablja izključno za ukrepe, katerih cilj je preprečiti distribucijo, razstavljanje in ponujanje nevarnega proizvoda potrošniku, izraz „odpoklic“ pa se uporablja samo za ukrepe, katerih cilj je doseči vrnitev nevarnega proizvoda, ki ga je proizvajalec ali distributer že dal na voljo potrošnikom.
recall of a product from consumers,
Preprečevalni in omejevalni ukrepi se lahko izvedejo v zvezi z nevarnimi proizvodi na pobudo proizvajalca ali distributerja, ki jih je dal in/ali distribuiral na trg („prostovoljni ukrepi“), ali na zahtevo organa države Efte, odgovornega za spremljanje skladnosti proizvodov z varnostnimi zahtevami („obvezni ukrepi“).
destruction of a withdrawn or recalled product.
Za namene RAPEX se obvezni in prostovoljni ukrepi opredelijo, kot sledi:
For the purpose of RAPEX, the term ‘withdrawal’ is used exclusively for measures aimed at preventing the distribution, display and offer of a dangerous product to consumers, while the term ‘recall’ is used only for measures aimed at achieving the return of a dangerous product that has already been made available to consumers by a producer or distributor.
Obvezni ukrepi:
Preventive and restrictive measures can be taken in relation to dangerous products either on the initiative of a producer or a distributor who placed and/or distributed it on the market (‘voluntary measures’) or as ordered by an authority of an EEA State competent to monitor the compliance of products with the safety requirements (‘obligatory measures’).
Ukrepi, ki jih sprejmejo, ali se odločijo, da jih bodo sprejeli, organi države Efte, pogosto v obliki upravne odločbe, ki zavezuje proizvajalca ali distributerja, da sprejmeta preprečevalni ali omejevalni ukrep v zvezi z nekim proizvodom, ki sta ga dala na trg.
For the purpose of RAPEX, the obligatory measures and voluntary measures are defined as follows:
Prostovoljni ukrepi:
Obligatory measures:
Preprečevalni in omejevalni ukrepi, ki jih proizvajalec ali distributer sprejme prostovoljno, tj. brez posredovanja organa države Efte.
Measures adopted or decided to be adopted by EFTA State authorities, often in the form of an administrative decision, which oblige a producer or a distributor to take preventive or restrictive action in relation to a specific product that they made available on the market.
O proizvodih, ki predstavljajo resno tveganje in ustreznih preprečevalnih ali omejevalnih ukrepih, ki jih sproži proizvajalec ali distributer, je treba takoj obvestiti pristojne organe držav EGP po mehanizmu obveščanja iz člena 5(3) GPSD;
Voluntary measures:
Priporočila in sporazumi s proizvajalci in distributerji, ki jih sklenejo organi držav Efte.
Preventive and restrictive measures adopted on a voluntary basis by a producer or a distributor, i.e. without any intervention of an authority of an EFTA State.
To vključuje sporazume, ki niso v pisni obliki in katerih rezultat je preprečevalni ali omejevalni ukrep proizvajalcev ali distributerjev v zvezi s proizvodi, ki predstavljajo resno tveganje in ki so jih proizvajalci ali distributerji dali na trg.
Products posing a serious risk and the related preventive or restrictive measures initiated by a producer or a distributor should be immediately notified to the competent authorities of EEA States under the notification mechanism provided for in Article 5(3) of the GPSD.
V skladu s členom 12(1) GPSD je treba obvezne in prostovoljne ukrepe prijaviti prek RAPEX.
Recommendations and agreements with producers and distributors concluded by EFTA State authorities.
O ukrepih, ki jih organi, pristojni za nadzor zunanjih meja, sprejmejo za preprečevanje trženja v EGP s proizvodom za potrošnike, ki predstavlja resno tveganje za zdravje in varnost potrošnikov (npr. odločitve o ustavitvi uvoza na nacionalni meji), je treba obvestiti Nadzorni organ Efte prek RAPEX na enak način, kot to velja za ukrepe, ki jih sprejmejo organi za nadzor trga in omejujejo trženje ali uporabo proizvoda.
This includes agreements which are not in written form and result in preventive or restrictive action taken by producers or distributors in relation to products posing a serious risk that they made available on the market.
O splošno veljavnih aktih, sprejetih na nacionalni ravni, katerih cilj je preprečiti ali omejiti trženje in uporabo splošno opisanih kategorij proizvodov za potrošnike zaradi resnih tveganj, ki jih predstavljajo za zdravje in varstvo potrošnikov, je treba obvestiti Nadzorni organ Efte prek sistema RAPEX.
Measures adopted by the authorities in charge of external border controls that prevent the marketing in the EEA of a consumer product posing a serious risk to the health and safety of consumers (e.g. decisions to stop the import at the national border) should be notified to the EFTA Surveillance Authority through RAPEX in the same manner as measures adopted by market surveillance authorities that restrict the marketing or use of a product.
Ta določba se uporablja za obvezne in prostovoljne ukrepe, čeprav se časovni razpored razlikuje.
Generally applicable acts adopted at national level and aimed at preventing or restricting the marketing and use of (a) generally described category(ies) of consumer products due to the serious risk they pose to the health and safety of consumers should not be notified to the EFTA Surveillance Authority through the RAPEX system.
Obvezni ukrepi
All such national measures that apply to only generally defined categories of products, such as all products in general or all products serving the same purpose — and not to (categories of) products specifically identified by their brand, specific look, producer, trader, model name or number, etc. — are notified to the EFTA Surveillance Authority under Directive 98/34/EC of the European Parliament and of the Council [10].2.2.5.
Te ukrepe je treba prijaviti prek RAPEX takoj po njihovem sprejetju ali po odločitvi o njihovem sprejetju, četudi obstaja verjetnost pritožbe zoper te ukrepe na nacionalni ravni, ali je bila pritožba zoper ukrepe že vložena, ali pa obstaja v zvezi s temi ukrepi obveznost uradne objave.
Article 12(1) of the GPSD requires EFTA States immediately to notify the EFTA Surveillance Authority through RAPEX of preventive and restrictive measures.
Ta pristop je v skladu s ciljem RAPEX, tj. zagotoviti hitro izmenjavo informacij med državami EGP, Nadzornim organom Efte in Komisijo, da se preprečita dobava in uporaba proizvodov, ki predstavljajo resno tveganje za zdravje ali varnost potrošnikov.
This provision applies to both obligatory and voluntary measures, although the timing of the notification is different.
Prostovoljni ukrepi
Obligatory measures
V skladu s členom 5(3) GPSD morajo proizvajalci in distributerji pristojne organe držav Efte obvestiti o prostovoljnem ukrepu in ukrepih za preprečevanje tveganja za potrošnike, ki ga predstavljajo proizvodi, ki so jih dali na trg (v nadaljnjem besedilu: prijava podjetja).
These measures are notified through RAPEX immediately after being adopted or the decision to adopt them, even if an appeal against them at national level is likely, they are already under appeal or subject to publication requirements.
Organ države Efte, ki prejme takšno prijavo s strani podjetja, uporabi to informacijo kot podlago za obvestilo RAPEX (ko so izpolnjena vsa merila za obveščanje RAPEX iz člena 12(1)) in ga pošlje takoj po prejemu prijave podjetja.
This approach is consistent with the objective of RAPEX, i.e. to ensure the rapid exchange of information between EEA States, the EFTA Surveillance Authority and the Commission in order to prevent the supply and use of products that pose a serious health or safety risk to consumers.
Če so prostovoljni ukrepi sprejeti v obliki sporazuma med proizvajalcem ali distributerjem in organom države Efte ali na podlagi priporočila organa proizvajalcu ali distributerju, je treba poslati obvestilo RAPEX takoj po sklenitvi takšnega sporazuma ali sprejetju takšnega priporočila.
Voluntary measures
Dodatek 3 k smernicam določa roke za predložitev obvestil Nadzornemu organu Efte prek sistema RAPEX za zagotovitev splošne uporabe obveznosti obveščanja RAPEX [11].
Under Article 5(3) of the GPSD, producers and distributors are obliged to notify the competent EFTA State authorities of voluntary action and measures taken to prevent risks to consumers posed by products they have made available on the market (‘business notification’).
O obveznih in prostovoljnih ukrepih obvešča prek RAPEX nacionalna kontaktna točka RAPEX, ki je odgovorna za vse informacije, ki jih njena država prenese prek tega sistema [12].
The authority of an EFTA State receiving this kind of business notification uses this information as the basis for a RAPEX notification (when all the RAPEX notification criteria provided for in Article 12(1) are met) and sends it immediately after receipt of the business notification.
V skladu s členom 5(3) GPSD morajo proizvajalci in distributerji sporočiti informacije v zvezi z nevarnim proizvodom pristojnim organom vseh držav EGP (hkrati), kjer je ta nevaren proizvod na voljo potrošnikom.
Where voluntary measures are adopted in the form of an agreement between a producer or a distributor and an authority of an EFTA State or on the basis of a recommendation from an authority to a producer or distributor, a RAPEX notification is submitted immediately after the conclusion of such an agreement or the adoption of such a recommendation.
Pogoji in podrobnosti glede tega obvestila so določeni v Prilogi I k GPSD.
To ensure common application of the RAPEX notification obligation, Appendix 3 to the Guidelines lays down specific deadlines for submitting notifications to the EFTA Surveillance Authority via RAPEX [11].
V takšnih primerih velja obveznost obveščanja prek RAPEX za vse države EGP, ki so prejele prijavo podjetja.
Both obligatory and voluntary measures are notified through RAPEX by the national RAPEX contact point, which is responsible for all information transmitted through the system by its country [12].
Da bi poenostavili praktično uporabo člena 12(1) GPSD in da bi se izognili nepotrebnemu podvajanju obvestil RAPEX, pa je bilo z državami EGP dogovorjeno, da pošlje obvestilo RAPEX samo država EGP, v kateri ima sedež proizvajalec/distributer, ki pošilja obvestilo (v nadaljnjem besedilu: glavna država EGP).
Article 5(3) of the GPSD requires producers and distributors to notify information concerning a dangerous product (at the same time) to the competent authorities in all EEA States where the dangerous product was made available.
Ko Nadzorni organ Efte, države Efte in Komisija obvestilo RAPEX preverijo in posredujejo prek sistema, morajo druge države EGP (zlasti tiste, ki so prejele enako prijavo podjetja) predložiti odzive na to obvestilo RAPEX.
The conditions and details for this notification are laid down in Annex I to the GPSD.
Če glavna država Efte ne predloži obvestila RAPEX v roku iz Dodatka 3 k smernicam in ne obvesti Nadzornega organa Efte o razlogih za zamudo, lahko katera koli druga država EGP, ki je prejela enako prijavo podjetja, predloži obvestilo prek sistema RAPEX.
In these situations, the RAPEX notification obligation applies to all EEA States that received a business notification.
Preden se organ države Efte odloči za predložitev obvestila RAPEX, vedno izvede ustrezno oceno tveganja, da oceni, ali proizvod iz obvestila predstavlja resno tveganje za zdravje in varnost potrošnikov, in ali je s tem izpolnjeno eno od meril za obveščanje RAPEX.
However, in order to simplify the practical application of Article 12(1) of the GPSD and to avoid unnecessary duplication of RAPEX notifications, it has been agreed with the EEA States that a RAPEX notification should be submitted only by the EEA State where the notifying producer/distributor is established (‘main EEA State’).
Ker RAPEX ni namenjen izmenjavi informacij glede proizvodov, ki ne predstavljajo resnega tveganja, obvestil o ukrepih v zvezi s takšnimi proizvodi v skladu s členom 12 GPSD ni mogoče pošiljati prek RAPEX.
Once a RAPEX notification has been validated and distributed through the system by the EFTA Surveillance Authority, the EFTA States and the Commission, other EEA States (especially the ones that also received the same business notification) should submit reactions to this RAPEX notification.
Dodatek 5 k smernicam določa metodo ocenjevanja tveganja, ki jo morajo uporabiti organi držav Efte za oceno stopnje tveganja, ki jo proizvod predstavlja za zdravje in varnost potrošnikov, in za odločitev o tem, ali je potrebno obvestilo RAPEX.
Where a main EFTA State does not submit a RAPEX notification by the deadline specified in Appendix 3 to the Guidelines and does not inform the EFTA Surveillance Authority of the reasons for the delay, any other EEA State that received the same business notification can submit a notification through RAPEX.
Oceno tveganja vedno opravi organ države Efte, ki je bodisi opravil preiskavo in sprejel ustrezne ukrepe ali spremljal prostovoljne ukrepe proizvajalca ali distributerja v zvezi z nevarnim proizvodom.
Before an authority of an EFTA State decides to submit a RAPEX notification, it always performs the appropriate risk assessment in order to assess whether a product to be notified poses a serious risk to the health and safety of consumers and thus whether one of the RAPEX notification criteria is met.
Preden se obvestilo RAPEX pošlje Nadzornemu organu Efte, kontaktna točka RAPEX vedno preveri oceno tveganja (ki se vključi v obvestilo), ki jo je opravil organ države Efte.
As RAPEX is not intended for the exchange of information on products posing non-serious risks, notifications on measures taken with regard to such products cannot be sent through RAPEX under Article 12 of the GPSD.
Kontaktna točka in odgovorni organ rešita vse nejasnosti, preden se informacije pošljejo prek RAPEX.
Appendix 5 to the Guidelines sets out the risk assessment method to be used by EFTA State authorities to assess the level of risks posed by consumer products to the health and safety of consumers and to decide whether a RAPEX notification is necessary.
Obvestila o nevarnih proizvodih za potrošnike, ki jih proizvajalci in distributerji v skladu s členom 5(3) GPSD predložijo pristojnim organom držav Efte, morajo vključevati podroben opis tveganja.
The risk assessment is always performed by an authority of an EFTA State that either carried out the investigation and took appropriate measures or monitored voluntary action taken with regard to a dangerous product by a producer or a distributor.
Po prejemu takšnega obvestila nacionalni organi pregledajo njegovo vsebino in analizirajo priloženo oceno tveganja.
Before a RAPEX notification is sent to the EFTA Surveillance Authority, the risk assessment performed by an authority of an EFTA State (to be included in the notification) is always verified by the RAPEX contact point.
Če se organ države Efte na podlagi predloženih informacij in neodvisne ocene tveganja odloči, da predstavlja prijavljeni proizvod resno tveganje za zdravje in varnost potrošnikov, je treba Nadzornemu organu Efte takoj poslati obvestilo RAPEX v zvezi s tem proizvodom (četrti pododstavek člena 12(1) GPSD).
Any unclear issues are resolved by the contact point with the authority responsible before a notification is transmitted through RAPEX.
Ocene tveganja, ki jih opravijo proizvajalci in distributerji, ne zavezujejo organov države Efte.
Notifications on dangerous consumer products submitted by producers and distributors under Article 5(3) of the GPSD to the competent authorities of EFTA States should include a detailed description of the risk.
Zato lahko organ države Efte sprejme sklep glede ocene tveganja, ki se razlikuje od sklepa v prijavi podjetja.