natgillin/translations-raw huggingface dataset:
This will form both the basis of their conclusion that the product satisfies the general safety obligation and can be marketed, and also provide a reference for subsequent reassessment of further risk information and whether the product continues to satisfy the definition of ‘safe product’ or notification needs to be made.
S tem bo ustvarjena tako osnova za njihov sklep, da izdelek izpolnjuje osnovno varnostno zahtevo in je lahko dan v promet, kot tudi zagotovljen sklic za naknadno presojo nadaljnjih informacij o tveganju in ali izdelek še vedno spada pod opredelitev „varni izdelek“ ali ga je treba prijaviti.
If producers or distributors become aware of information or new evidence showing that a product may be dangerous they should determine whether such information leads to the conclusion that a product is actually dangerous.
Če proizvajalci ali distributerji dobijo nove informacije ali dokaze o tem, da bi izdelek lahko bil nevaren, morajo ugotoviti, ali te informacije peljejo k sklepu, da je ta izdelek dejansko nevaren.
The guidance referred to in this document was developed for the 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 [3].
Navodila, na katera se ta dokument nanaša, so bila razvita za Smernice za upravljanje sistema Skupnosti za hitro izmenjavo informacij (RAPEX) in za prijave, predložene v skladu s členom 11 Direktive 2001/95/ES [3].
It is presented here in order to assist producers or distributors to decide if a specific situation caused by a consumer product justifies a notification to the competent authorities.
Tukaj so predstavljena z namenom pomagati proizvajalcem in distributerjem pri odločitvi, ali posebne okoliščine v zvezi s potrošniškim izdelkom upravičujejo prijavo pristojnim organom.
It represents a methodological framework intended to promote consistency and does not take account of all possible factors, but should facilitate consistent, reasoned, professional judgements on the risks posed by specific consumer products.
Predstavljajo metodološki okvir, namenjen spodbujanju skladnosti, in ne upoštevajo vseh možnih dejavnikov, ampak naj bi olajšala usklajeno obrazloženo poklicno presojo o tveganjih, ki jih povzročijo določeni potrošniški izdelki.
However, if producers or distributors consider that they have clear evidence based on different considerations of the need for notification they must carry out the notification.Producers or distributors should analyse the information collected and decide whether a particular hazardous situation should be notified to the authorities taking into account:
Če pa so proizvajalci ali distributerji prepričani, da imajo jasne dokaze o potrebnosti prijave, jo morajo izvesti.Proizvajalci ali distributerji preučijo zbrane informacije in se odločijo, ali je določeno nevarno okoliščino treba prijaviti pristojnim organom; upoštevati morajo naslednje:
the gravity of the outcome of a hazard, depending on the severity and probability of the possible health/safety damage.
Težo posledic nevarnosti, ki so odvisne od resnosti in verjetnosti morebitne škodljivosti za zdravje/varnost.
Combining the severity and probability gives an assessment of the gravity of the risk.
Kombinacija resnosti in verjetnosti sestavlja oceno o teži tveganja.
The accuracy of this assessment will depend upon the quality of the information available to the producer or distributor.
Točnost te ocene je odvisna od kakovosti podatkov, ki so na voljo proizvajalcu ali distributerju.
The severity of health/safety damage for a given hazard should be that for which there is reasonable evidence that the health/safety damage attributable to the product could occur under foreseeable use.
Resnost škodljivosti za zdravje/varnost za določeno nevarnost se lahko oceni, če obstajajo utemeljeni dokazi, da predvidena uporaba izdelka lahko ogrozi zdravje/varnost potrošnikov.
This could be the worst case from health/safety damages that have occurred with similar products.
To bi lahko bil najhujši primer škodljivosti za zdravje/varnost, ki se je zgodil s podobnimi izdelki.
The probability of health/safety damage for a normal user who has an exposure corresponding to the intended or reasonably expected use of the defective product has also to be considered as well as the probability of the product being or becoming defective.
Verjetnost škodljivosti za zdravje/varnost običajnega uporabnika, ki je izpostavljen vplivom izdelka z napako pri namenski oziroma smiselno predvideni uporabi, je treba obravnavati enako kot vsako možnost, da ima izdelek napako ali da bi jo lahko dobil.
The decision to notify should not be influenced by the number of products on the market or by the number of people who could be affected by a dangerous product.
Na odločitev o prijavi ne sme vplivati število v promet danih izdelkov ali število ljudi, ki bi jih nevarni izdelek lahko prizadel.
These factors may be taken into account in deciding on the type of action to be taken to solve the problem.
Omenjena dejavnika se lahko upoštevata pri odločanju o vrsti ukrepov, ki se sprejmejo za rešitev problema.
the factors which affect the level of the risk such as the type of user and, for non-vulnerable adults, whether the product has adequate warnings and safeguards and whether the hazard is sufficiently obvious.
Dejavnike, ki vplivajo na stopnjo tveganja, kot na primer tip uporabnika, in, za manj občutljive odrasle osebe, ali ima izdelek ustrezna opozorila in zaščitne ukrepe in ali je nevarnost dovolj očitna.
Society accepts higher risks in some circumstances (e.g. such as motoring), than in others (e.g. such as children's toys).
Družba v nekaterih razmerah pristaja na višje stopnje tveganja (npr. avtomobilizem) kot v drugih (npr. otroške igrače).
It is considered that among the important factors affecting the level of risk are the vulnerability of the type of person affected and, for non-vulnerable adults, the knowledge of the risk and the possibility of taking precautions against it.
Meni se, da sta med pomembnimi dejavniki, ki vplivajo na stopnjo tveganja, občutljivost tipa prizadete osebe ter za manj občutljive odrasle osebe poznavanje tveganja in možnost, da sprejmejo varnostne ukrepe.
The type of person using a product should be taken into account.
Upošteva se tip uporabnika izdelka.
If the product is likely to be used by vulnerable people (such as children, the elderly) the level of risk which should be notified should be set at a lower level.
Če obstaja verjetnost, da bodo izdelek uporabljali ranljivi ljudje (otroci, starejši), je stopnjo tveganosti, ki jo je treba prijaviti, treba zmanjšati.
For non-vulnerable adults the level of risk which is high enough to require notification should depend on whether the hazard is obvious and necessary for the function of the product and whether the manufacturer has taken adequate care to provide safeguards and warnings, especially if the hazard is not obvious.
Za manj občutljive odrasle uporabnike je stopnja tveganja, ki je dovolj velika, da izdelek zahteva prijavo, odvisna od očitnosti nevarnosti in njene potrebnosti za delovanje izdelka in od tega, ali je izdelovalec poskrbel za zaščitne ukrepe in opozorila, še zlasti če nevarnost ni očitna.
Annex II gives more details on the risk estimation and evaluation assessment method developed for the 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.
Priloga II bolj podrobno navaja ocenjevanje tveganja in metode vrednotenja, ki so bile razvite za Smernice za upravljanje sistema Skupnosti za hitro izmenjavo informacij (RAPEX), in za prijave, predložene v skladu s členom 11 Direktive 2001/95/ES.
Other methods may be suitable and the choice of method may depend on the resources and information available.
Ustrezne so lahko tudi druge metode in metodo se lahko izbere glede na vire in razpoložljive informacije.
Producers and distributors should be encouraged to contact the authorities if they have evidence of a potential problem in order to discuss whether a notification is appropriate.
Če imajo proizvajalci in distributerji dokaze o morebitnem problemu so spodbujeni, da navežejo stik z oblastmi z namenom razprave o primernosti prijave.
The authorities will be responsible for assisting and helping them to correctly fulfil their notification obligation.
Oblasti bodo odgovorne za to, da jim bodo nudile podporo in pomoč pri izpolnjevanju obveznosti v zvezi s prijavo.
Criteria for non-notification
Merila za neobveznost prijave
The flow of information must be manageable for both sides: the economic operators and the authorities.
Pretok informacij mora biti obvladljiv za obe stranki: gospodarske subjekte in oblasti.
The notification procedure should deal only with justified cases taking into account the criteria mentioned above and avoid overloading the system with non-relevant notifications.
Prijavni postopki obravnavajo le upravičene primere ob upoštevanju zgoraj omenjenih meril in izogibanju preobremenitve sistema z neustreznimi prijavami.
In order to assess if a notification by producers or distributors to the competent authorities is justified, it is also relevant to know on what terms a notification is not required.
Z namenom, da bi ocenili, ali so prijave s strani proizvajalcev ali distributerjev pristojnim organom upravičene, je treba vedeti, v katerih okoliščinah prijava ni obvezna.
The objective is to prevent a possible proliferation of notifications of measures, actions or decisions related to ‘isolated circumstances or products’ which do not require any verification, monitoring or action by the authorities and do not provide information useful for risk assessment and consumer protection.
Cilj ocenjevanja je preprečiti morebitno širjenje prijav ukrepov, delovanja ali odločb, ki se nanašajo na „posebne okoliščine in izdelke“, za katere pristojni organi ne zahtevajo preverjanja, spremljanja ali ukrepanja in ne zagotavljajo podatkov, uporabnih za oceno tveganja in varstvo potrošnikov.
This may happen when it is clear that the risk is related to a limited number of well-identified products (or batches) only, and the producer or distributor has solid evidence to conclude that the risk has been fully controlled and its cause is such that knowledge of the incident does not represent useful information for the authorities (such as the malfunctioning of a production line, errors in handling or packaging, etc.).
Neobvezno prijavljanje pride v poštev, ko je jasno, da je tveganje povezano z omejeno količino dobro prepoznavnih izdelkov (ali njihovih serij) in če imata proizvajalec ali distributer trdne dokaze, da je tveganje pod popolnim nadzorom in je njegov vzrok tak, da poznavanje nezgode za pristojne organe ne predstavlja uporabnih informacij (npr. okvara na proizvodni liniji, napačno manipuliranje ali pakiranje itd.)
Producers and distributors do not need to notify under the GPSD:
Proizvajalcem in distributerjem v okviru določil GPSD ni treba prijaviti:
products that are not within the scope of Articles 1 and 2(a) GPSD such as: antiques, products not intended for use by consumers and not likely to be used by consumers, second-hand products supplied for repair;
izdelkov, ki ne ustrezajo opredelitvi iz členov 1 in 2(a) GPSD, kot so: starine, izdelki, ki niso namenjeni za uporabo potrošnikov oziroma bi jih potrošniki lahko uporabili, rabljeni izdelki, ki čakajo na popravilo,
products that are not within the scope of Article 5(3) GPSD such as: those covered by specific notification procedures of other Community legislation;
izdelkov, ki ne ustrezajo opredelitvi iz člena 5(3) GPSD, kot so: tisti, za katere se ne uporabljajo posebni prijavni postopki druge zakonodaje Skupnosti,
problems related to the functional quality of the product, not to its safety;
problemov, ki so povezani s kvaliteto delovanja izdelka, ne pa z njegovo varnostjo,
problems related to non-compliance with applicable rules not affecting safety in such a way that the product could be considered ‘dangerous’;
problemov, ki so povezani s kršitvijo pravil, ki se uporabljajo, a ki na varnost ne vplivajo na način, da bi izdelek lahko šteli za „nevarnega“,
when the producer/distributor knows that the authorities have already been informed and have all the required elements of information.
v primeru, da proizvajalec/distributer ve, da so bili pristojni organi obveščeni in da so jim bile posredovane vse potrebne informacije.
In particular, if retailers receive information on a dangerous product from their producer/distributor or from a professional organisation that diffuses the information provided by a producer/distributor, they should not inform the authorities if they know that the authorities have already been informed by the producer or distributor.
Zlasti če trgovci na drobno dobijo informacije o nevarnih izdelkih od proizvajalcev/distributerjev oziroma od poklicne organizacije, ki razširja informacije, ki ji jih le-ti posredujejo, omenjenim trgovcem ni treba obvestiti pristojnih organov, če vedo, da je to že storil proizvajalec ali distributer.
NOTIFICATION PROCEDURE
PRIJAVNI POSTOPEK
Who must notify
Kdo je dolžan prijaviti izdelke
The obligation to notify applies to both producers and distributors, within the limits of their respective activities and in proportion to their responsibilities.
Prijavna obveznost se uporablja tako za proizvajalce kot distributerje in sicer v mejah njihovih dejavnosti ter v sorazmerju z njihovo odgovornostjo.
There may be doubts as to who should be the first to give information.
Lahko se pojavijo dvomi o tem, kdo je prvi dolžan dati informacijo.
Because of this it will be useful for everyone involved in the supply chain to discuss the practical arrangements related to the responsibility for notification before the need arises.
Zaradi tega je za vsakega udeleženca v dobavni verigi uporabna razprava o praktičnih pravilih, ki se nanašajo na prijavno obveznost, še preden nastane potreba po njej.
Then if a notification becomes necessary, the various operators will know what to do and unnecessary double notifications will be avoided.
Če pa nastane potreba po prijavi, bodo različni udeleženci znali ustrezno ukrepati in se tako izognili nepotrebnim dvojnim prijavam.
In addition, direct contact between the authorities and business is highly important if businesses have doubts about the fulfilment of their notification obligation.
Poleg tega je zelo pomembno neposredno sodelovanje med pristojnimi organi in podjetji, če imajo slednja kakršen koli dvom o izpolnjevanju svoje prijavne obveznosti.
If it is the manufacturer or the importer of the product that first has evidence that a product is dangerous, they should inform the competent national authority and forward a copy of the information to retailers and distributors.
Če sta izdelovalec ali uvoznik izdelka tista, ki imata prva dokaze, da je izdelek nevaren, nemudoma obvestita pristojen nacionalni organ in pošljeta izvod podatkov trgovcem na drobno in distributerjem.
A distributor or retailer receiving product hazard information from a manufacturer or importer must inform the authorities unless it knows that the national authority has already been adequately informed by the producer or by another authority.
Trgovec ali distributer, ki prejme obvestilo o nevarnosti izdelka od izdelovalca ali uvoznika, mora obvestiti pristojni organ, razen če ve, da je izdelovalec ali drug organ že obvestil nacionalni organ.
If it is the retailers or distributors of a product that first have evidence that it is dangerous, they should inform the competent national authority and forward a copy of the information to the manufacturer or importer.
V primeru, da sta prva subjekta, ki imata dokaze o nevarnosti izdelka trgovec na drobno ali distributer, morata takoj obvestiti pristojni nacionalni organ in poslati izvod podatkov izdelovalcu oziroma uvozniku.
A manufacturer or importer receiving product hazard information from a retailer or distributor must complete the information provided by them by passing to the authority(ies) all information they have concerning the dangerous product, in particular identification of other distributors or retailers of the product in order to ensure the product's traceability.
Izdelovalec oziroma uvoznik morata takoj, ko od trgovca na drobno ali distributerja prejmeta informacije o nevarnosti izdelka, le-te dopolniti z svojimi informacijami o zadevnem izdelku in še zlasti identificirati druge distributerje ali trgovce na drobno ter te informacije nasloviti na pristojni/-ne organ/-ne, da bi se na ta način zagotovila sledljivost izdelka.
Distributors who have doubts about the safety of a product or whether a dangerous product represents an ‘isolated case’ must transmit to the producer the information they have.
Distributerje, ki imajo pomisleke o varnosti izdelka oziroma o tem, ali nevarni izdelek predstavlja „posebni primer“, morajo svoje podatke posredovati proizvajalcu.
They can also contact the competent authorities for advice on how to proceed.
Za nasvet o nadaljnjem ravnanju se lahko obrnejo na pristojne organe.
Many hazard situations are recognised by producers only as a result of an aggregated assessment of individual communications received from different retailers or distributors.
Proizvajalci številne nevarne situacije prepoznajo le na podlagi zbirne ocene posameznih sporočil, ki so jih sprejeli od različnih trgovcev na drobno in distributerjev.
The producer has the responsibility of assessing the information in order to determine the exact origin of the possible risk and to take the measures which appear to be necessary, including notification of the authorities.
Proizvajalec je odgovoren za ocenjevanje informacij, da bi določil natančen vzrok možnega tveganja in uvedel potrebne ukrepe, vključno s prijavo pristojnim organom.
A company should assign responsibility for the information to be notified to someone with sufficient knowledge of the product.
Podjetje dodeli pristojnost za podatke, ki jih je treba prijaviti, nekomu, ki dobro pozna zadevni izdelek.
To whom the notification should be presented
Komu naj se prijave predložijo
Producers and distributors are required by the GPSD to submit their notifications to the market surveillance/enforcement authorities of all the Member States where the product has been marketed or otherwise supplied to consumers.
GPSD od proizvajalcev in distributerjev zahteva, da svoje prijave predložijo organom za tržni nadzor/izvrševanje v vseh državah članicah, kjer je izdelek dan v promet ali drugače dobavljen potrošnikom.
Each Member State must designate the authority in charge of receiving such notifications.
Vsaka država članica mora določiti organ, ki je pristojen za sprejemanje takšnih prijav.
A list of the authorities designated to that effect is on the Commission's website.
Seznam organov, ki so v ta namen določeni, se nahaja na spletni strani Komisije.
Annex I of the GPSD states that the information specified in Article 5(3) must be submitted to the competent authorities in the Member States where the products in question are or have been marketed or otherwise supplied to consumers.
Priloga I GPSD določa, da morajo biti v primeru, da so zadevni izdelki dani v promet oziroma drugače dobavljeni potrošnikom, vse informacije iz člena 5(3) predložene pristojnim organom držav članic.
However, it is desirable to reduce the burden on producers and distributors by introducing arrangements simplifying the practical application of the requirements in question, while ensuring that all the interested authorities are informed.
Vendar je zaželeno čim bolj razbremeniti proizvajalce in distributerje z uvedbo ureditve, ki poenostavi praktično izvajanje zadevnih zahtev ter hkrati zagotovi obveščenost vseh zainteresiranih organov.
These arrangements will also contribute to prevent multiple notifications concerning the same fault.
Ta ureditev lahko prispeva k temu, da se izogne večkratni prijavi, ki zadeva isto napako.
Therefore, producers and distributors have the option of submitting the required information to the authority of the Member State in which they are established, if one of these two conditions is fulfilled:
Zato imajo proizvajalci in distributerji možnost, da predložijo zahtevane podatke organu v državi članici, kjer imajo sedež, a le, če je izpolnjen eden od dveh pogojev:
The risk is notified as being ‘serious’ or is considered ‘serious’ by the receiving authority and this authority decides to introduce a notification concerning the product in question under the RAPEX system.
Tveganje je prijavljeno kot „resno“ ali ga organ prejemnik šteje za „resno“ tveganje in ta organ se odloči za uvedbo prijave zadevnega izdelka v okviru sistema RAPEX.
In such a case, the receiving authority should without delay inform the producer or distributor who has submitted the information of its decision to inform the other Member States’ authorities through RAPEX.
V takem primeru organ prejemnik nemudoma obvesti proizvajalca ali distributerja, ki je podatke predložil, o svoji odločitvi, da bo države članice obvestil prek Rapexa.
The risk is notified as not being ‘serious’ or is not considered serious by the receiving authority, but this authority has communicated to the producer or distributor who has submitted the information its intention to forward the information, through the Commission, to the authorities of the other Member States [4] where, according to the indications of the producer or distributor, the product is/has been placed on the market.
Tveganje ni prijavljeno kot „resno“ ali se ne šteje za resno s strani organa prejemnika, vendar je ta organ sporočil proizvajalcu ali distributerju, ki je podatke predložil, da namerava predložene podatke prek Komisije poslati drugim državam članicam [4], ko je po navedbah proizvajalca/distributerja izdelek bil/je dan v promet.
In such a case, the receiving authority must inform the producer or distributor without delay.
V takem primeru mora organ prejemnik nemudoma obvestiti proizvajalca ali distributerja.
The producer or distributor that only informs the authority of the country where it is located should always provide this authority with the available information about other countries where the product has been marketed.
Proizvajalec ali distributer, ki obvesti zgolj organe države, kjer ima sedež, omenjene organe obvesti tudi o drugih državah, kjer je zadevni izdelek dan v promet.
If the national authorities conclude or obtain evidence that a product placed on the market is dangerous and they have not been informed by its producer or distributors, they must examine whether and when the relevant operators should have notified and decide appropriate action, including possible sanctions.
Če nacionalni organi ugotovijo ali pridobijo dokaze, da je v promet dani izdelek nevaren in jih njegov proizvajalec ali distributer o tem ni obvestil, morajo preučiti, če in kdaj bi jih moral zadevni subjekt o tem uradno obvestiti ter v skladu s tem ustrezno ukrepati tudi z morebitnimi sankcijami.
How to notify
Kako prijavljati
However, no company should delay a notification because part of the information is not yet available.
Vendar pa nobeno podjetje ne sme zavlačevati s prijavo, če določenih podatkov še nima.
It may be helpful to divide the form into two parts.
Obrazec je smiselno razdeliti na dva dela.
The first part should be filled in immediately (Sections 1 to 5) and the second part (Section 6) should be filled in when the information has been collected (a timetable for providing the missing information should be transmitted) and then when there is a serious risk situation or when the producer/distributor opts to submit the notification only to the authority of the Member State in which they are established.
Prvi del (Oddelki 1 do 5) se izpolni takoj, drugi del (Oddelek 6) pa se izpolni, ko so zbrani vsi podatki (predloži se časovni okvir za zagotovitev manjkajočih podatkov) oziroma ko obstaja resno tveganje ali ko proizvajalec/distributer izbere predložitev prijave le organu države članice, v kateri ima sedež.
Notification should not be delayed when some of the fields in a section cannot be completed.
S prijavo se ne zavlačuje, ne glede na to če se določenih polj v oddelku ne more izpolniti.