natgillin/translations-raw huggingface dataset:
The obligation to inform the authorities about dangerous products is an important element for improved market surveillance as it enables the competent authorities to monitor whether the companies have taken appropriate measures to address the risks posed by a product already placed on the market and to order or take additional measures if necessary for avoiding risks.
Obveznost obveščanja organov oblasti o nevarnih izdelkih je pomemben element za izboljšanje tržnega nadzora, saj pristojnim organom omogoča spremljanje, ali so podjetja sprejela ustrezne ukrepe, ki zadevajo tveganja, ki jih predstavljajo v promet dani proizvodi, in da po potrebi predpišejo ali sprejmejo dodatne ukrepe, da bi se izognilo tveganjem.
In order to prevent a disproportionate burden on producers, distributors and the competent authorities and to facilitate the effective application of this obligation it is appropriate to establish, in addition to a standard form, operational guidelines concerning the most relevant notification criteria as well as practical aspects of notification, which are put forward in particular in order to assist producers and distributors in the implementation of the provisions laid down in Article 5(3) of Directive 2001/95/EC,
Da bi se izognilo nesorazmerni obremenitvi proizvajalcev, distributerjev in pristojnih organov ter da bi se spodbudilo učinkovito izvajanje te obveznosti, je ob standardnem obrazcu ustrezno določiti operativne smernice glede najpomembnejših meril iz prijave kot tudi praktične vidike prijave, ki so oblikovane zlasti z namenom, da bi se pomagalo proizvajalcem in distributerjem pri izvajanju določb iz člena 5(3) Direktive 2001/95/ES –
The Commission hereby adopts guidelines for the notification of dangerous consumer products by producers and distributors to the competent authorities of the Member States, in accordance with Article 5(3) of that Directive 2001/95/EC.
Komisija v skladu s členom 5(3) Direktive 2001/95/ES sprejme smernice za prijavo nevarnih potrošniških izdelkov pristojnim organom držav članic s strani proizvajalcev in distributerjev.
The guidelines are set out in the Annex to this Decision.
Smernice so opredeljene v Prilogi k tej odločbi.
Guidelines for the notification of dangerous consumer products to the competent authorities of the Member States by producers and distributors in accordance with Article 5(3) of Directive 2001/95/EC
Smernice za proizvajalce in distributerje pri postopku prijavljanja nevarnih potrošniških izdelkov pristojnim organom držav članic v skladu s členom 5(3) direktive 2001/95/ES
Background and objectives of the guidelines
Osnovna določila in cilji smernic
The General Product Safety Directive (GPSD) aims to ensure that non-food consumer products placed on the EU market are safe.
Cilj Direktive o splošni varnosti izdelkov (GPSD) je zagotoviti neoporečnost neživilskih potrošniških izdelkov, ki vstopajo na trg EU.
It includes an obligation for producers and distributors to provide information on findings and measures concerning dangerous products to the competent authority.
Direktiva vključuje obvezo proizvajalcev in distributerjev, da pristojnim organom zagotovijo informacije o izsledkih in ukrepih, ki se nanašajo na nevarne izdelke.
The GPSD mandates the Commission, assisted by the GPSD Committee of Member States, to draw up a guide defining simple and clear criteria to facilitate the effective application of this obligation.
GPSD pooblašča Komisijo, da ob pomoči odbora GPSD držav članic pripravi priročnik z opredelitvijo preprostih in jasnih meril, ki bi olajšala učinkovito izvajanje zgoraj omenjene obveze.
In addition the guide is to simplify the work of economic operators and the competent authorities by defining the particular conditions, especially isolated circumstances or products, for which notification is not appropriate.
Poleg tega naj bi priročnik z določitvijo posebnih okoliščin, še posebej posebnih okoliščin ali izdelkov, zaradi katerih prijava ni obvezna, poenostavil delo gospodarskih subjektov in pristojnih organov.
The guide should also define the content and lay out of the standard form for notifications by producers and distributors to the authorities.
Poleg tega je treba v priročniku določiti vsebino in osnutek standardnega obrazca za prijave, ki ga morajo proizvajalci in distributerji predložiti pristojnim organom.
In particular the Commission is responsible for ensuring the effectiveness and proper functioning of the notification procedure.
Komisija je zlasti odgovorna za zagotovitev učinkovitosti in ustrezno izvajanje prijavnega postopka.
The objectives of these guidelines are therefore to:
Cilji smernic so torej naslednji:
clarify from the operational point of view the scope of producers’ and distributors’ obligations in such a way that only the information relevant for risk management is notified and that any information overload is prevented;
razjasniti obseg obveznosti proizvajalcev in distributerjev s praktičnega vidika in sicer na tak način, da prijava zahteva le informacije, ki so pomembne za obvladovanje tveganja, presežne informacije pa so onemogočene;
make reference to relevant criteria for applying the concept of ‘dangerous products’;
sklicevati se na tista merila, ki so ključna za opredelitev „nevarnih izdelkov“;
provide criteria for identifying the ‘isolated circumstances or products’ for which notification is not relevant;
zagotoviti merila za opredelitev „posebnih okoliščin ali izdelkov“, za katere prijava ni obvezna;
define the content of notifications, in particular the information and data required, and the form to be used;
določiti vsebino prijav in zlasti vseh potrebnih informacij in podatkov ter prijavnega obrazca;
identify to whom and how the notification should be submitted;
določiti komu in na kakšen način je prijavni obrazec vročen;
define the follow-up action to be taken by the Member States receiving a notification and the information to be provided on such follow-up.
določiti nadaljnje ukrepe, ki jih države članice sprejmejo po prejetju prijave, in informacije, ki jih zagotovijo za takšne nadaljnje ukrepe.
Status and further developments of the guidelines
Status in nadaljnji razvoj smernic
These are operational guidelines.
To so operativne smernice.
These guidelines have been adopted by the Commission, after consultation of the Member States within the GPSD Committee acting in accordance with the advisory procedure.
Te smernice je po posvetovanju z zastopniki držav članic, zbranimi v odboru GPSD, v skladu z svetovalnim postopkom sprejela Komisija.
They therefore represent the reference document for the application of the provisions of the GPSD concerning notification of dangerous consumer products to the competent authorities of the Member States by producers and distributors.
Zato smernice proizvajalcem in distributerjem predstavljajo referenčni dokument za uporabo predpisov GPSD, ki zadevajo prijavo nevarnih potrošniških izdelkov pristojnim organom držav članic.
Further developments
Nadaljnji razvoj
These guidelines will need to be adapted in the light of experience and of new developments.
Te smernice bo treba prilagoditi na podlagi izkušenj in razvoja.
The Commission will update or amend them as necessary in consultation with the Committee referred to in Article 15 GPSD.
Komisija jih bo po potrebi dopolnila in spremenila, ob tem pa se bo posvetovala s posebnim odborom, na katerega se nanaša člen 15 GPSD.
To whom the guidelines are addressed
Na koga so smernice naslovljene
These guidelines are addressed to the Member States.
Te smernice so naslovljene na države članice.
They should be used to guide producers and distributors of consumers’ products as well as the national authorities designated as contact points to receive information from producers and distributors, in order to ensure the effective and consistent application of the notification requirement in question.
Uporabljajo se za usmerjanje proizvajalcev in distributerjev potrošniških izdelkov kot tudi nacionalnih organov, ki so določeni kot kontaktne službe za pridobivanje informacij s strani prvih, z namenom zagotovitve učinkovitega in skladnega izpolnjevanja zadevne zahteve iz prijave.
SUMMARY OF THE PROVISIONS IN THE GPSD ON NOTIFICATION BY PRODUCERS AND DISTRIBUTORS
POVZETEK PREDPISOV DIREKTIVE O SPLOŠNI VARNOSTI IZDELKOV (GPSD), KI ZA PROIZVAJALCE IN DISTRIBUTERJE VELJAJO NA PODROČJU PRIJAVLJANJA
Obligation to inform competent authorities in the Member States
Obveznost obveščanja pristojnih organov v državah članicah
Under the GPSD, producers and distributors must inform the competent authorities if they know or ought to know, on the basis of the information in their possession and as professionals, that a product they have placed on the market is dangerous (according to the definitions and criteria of the Directive).
V skladu z GPSD morajo proizvajalci in distributerji obvestiti pristojne organe, če vedo oziroma bi na podlagi razpoložljivih podatkov in kot strokovnjaki morali vedeti, da izdelek, ki so ga dali v promet, spada med nevarne izdelke (po opredelitvah in merilih Direktive).
‘Isolated’ circumstances or products are excluded from the obligation to notify.
V „posebnih“ okoliščinah določenih izdelkov ni obvezno prijaviti.
Producers and distributors could give the authorities preliminary information about a potential product risk as soon as they are aware of it.
Proizvajalci in distributerji lahko pristojne organe o potencialno nevarnih izdelkih obvestijo predhodno in sicer takoj, ko jih spoznajo za take.
With this information the authorities may be able to help producers and distributors to carry out their notification duty correctly.
S takšnimi informacijami lahko pristojni organi pomagajo proizvajalcem in distributerjem, da svojo prijavno dolžnost pravilno izpolnijo.
In addition, they are encouraged to contact their national authorities if they have a doubt as to whether a product risk exists.
Poleg tega se jih spodbudi, da stopijo v stik s svojimi nacionalnimi oblastmi, če dvomijo v obstoj nevarnosti izdelkov.
Reason and objectives for the provision on notification
Razlog in nameni prijavnega predpisa
The obligation to inform the authorities about dangerous products is an important element for improved market surveillance and risk management.
Obveznost informiranja pristojnih organov o nevarnih izdelkih je pomemben element za izboljšanje tržnega nadzora in obvladovanje tveganja.
Producers and distributors, within the limits of their respective activities, are responsible in the first instance for preventing risks from dangerous products.
Proizvajalci in distributerji so v prvi vrsti, v okviru svojih dejavnosti, odgovorni za preprečevanje tveganj, ki jih prinašajo nevarni izdelki.
However, producers and distributors may not have taken (or may not be in a position to take) all the necessary measures.
Obstaja možnost, da proizvajalci in distributerji niso uvedli vseh potrebnih ukrepov (ali pa niso v položaju, da bi ustrezno ukrepali).
Moreover, other products of the same type may pose risks similar to those related to the products considered.
Poleg tega lahko pomenijo tveganja tudi drugi izdelki istega tipa, podobna tistim v zvezi z zadevni izdelki.
The purpose of the notification procedure is to enable the competent authorities to monitor whether the companies have taken appropriate measures to address the risks posed by a product already placed on the market and to order or take additional measures if necessary to prevent risks.
Namen prijavnega postopka je omogočiti pristojnim organom lažje spremljanje, ali so podjetja uvedla ustrezne ukrepe za obravnavo tveganj, ki jih povzročijo izdelki, dani v promet, in po potrebi odreditev oziroma uvedbo dodatnih ukrepov za zaščito pred tveganji.
The notification also allows the competent authorities to assess whether they should check other similar products on the market.
Prijava tudi omogoča pristojnim organom, da ocenijo, ali je treba preveriti tudi druge podobne izdelke na trgu.
Therefore, competent authorities must receive adequate information to enable them to assess whether an economic operator has taken adequate measures with regard to a dangerous product.
Zato morajo pristojni organi prejeti ustrezne informacije, da bi lahko ocenili, ali je gospodarski subjekt glede nevarnega izdelka ustrezno ukrepal.
In this respect it should be noted that the GPSD entitles the competent authorities to request additional information if they feel unable to assess whether a company has taken adequate measures with regard to a dangerous product.
S tega vidika je treba poudariti, da GPSD pooblašča pristojne organe, da lahko zahtevajo dodatne informacije, če ne morejo oceniti, ali je podjetje glede nevarnega izdelka ustrezno ukrepalo.
NOTIFICATION CRITERIA
PRIJAVNA MERILA
The first requirement for notification under the GPSD is that the product should be within the scope of this Directive and that the conditions of Article 5(3) are met.
Prva zahteva GPSD na področju prijavljanja je, da mora izdelek spadati v področje uporabe te direktive in da so izpolnjeni pogoji iz člena 5(3).
It should be noted that separate requirements for the notification of dangerous food products are established by EU food law (Regulation (EC) No 178/2002 of the European Parliament and of the Council [1]).If Community sectoral legislation on product safety establishes notification obligations with the same objectives that excludes the applicability of the GPSD obligation to the categories of products covered by the sectoral requirements.
Pri tem je treba poudariti, da je živilska zakonodaja EU (Uredba (ES) št. 178/2002 [1]) za prijavo nevarnih živilskih izdelkov uvedla ločene zahteve. V primeru, da bi sektorska zakonodaja o varnosti izdelkov uvedla prijavne obveznosti z enakimi zahtevami, bi to izključevalo izvajanje obveznosti GPSD za kategorije izdelkov, ki jih urejajo sektorske zahteve.
In addition, it is worth noting that these guidelines are not relevant for, and do not interfere with the application of requirements concerning ‘safeguard clauses’ or other notification procedures established by vertical Community legislation on product safety.
Poleg tega je pomembno poudariti, da se te smernice ne nanašajo na zahteve niti ne ovirajo izvajanja zahtev, ki zadevajo „zaščitne klavzule“ oziroma druge prijavne postopke, določene z vertikalno zakonodajo Skupnosti o varnosti izdelkov.
Important criteria for notification are:
Pomembna merila za prijavo so:
the product is within the scope of Article 2(a) of the Directive: a product intended for or likely to be used by consumers (including in the context of providing a service and second-hand products);
izdelek sodi na področje uporabe člena 2(a) Direktive: izdelek je namenjen za uporabo potrošnikov ali bi ga le-ti lahko uporabili (vključno z nudenjem storitev ali rabljenimi izdelki),
Article 5 of the Directive is applicable (that is, no specific similar obligation is established by other Community legislation, cf. Article 1(2)(b) GPSD);
člen 5 Direktive se uporablja (tj. ni nobene podobne obveznosti, ki jo določa druga zakonodaja Skupnosti, cf. člen 1(2)(b) GPSD),
the product is on the market;
izdelek je dan v promet,
the producer or distributor has evidence (from monitoring the safety of products on the market, from testing, from quality control or from other sources) that the product is dangerous as defined by the GPSD (it does not satisfy the general safety requirement, taking into account the safety criteria of the GPSD) or does not satisfy the safety requirements of the relevant Community sectoral legislation applicable to the product considered;
proizvajalec oziroma distributer ima dokazna sredstva (pridobljena s spremljanjem varnosti izdelkov na trgu, testiranjem, nadzorom kakovosti ali iz drugih virov), da izdelek po opredelitvi GPSD spada med nevarne izdelke (ne izpolnjuje splošnih varnostnih zahtev ob upoštevanju varnostnih meril iz GPSD) ali ne izpolnjuje varnostnih zahtev ustrezne sektorske zakonodaje Skupnosti,
the risks are therefore such that the product may not remain on the market and producers (and distributors) have the obligation to take appropriate preventive and corrective action (modifying the product, warnings, withdrawal, recalling, etc. depending on the specific circumstances).
tveganja so takšna, da izdelek ne more ostati na trgu in proizvajalci (in distributerji) so obvezani uvesti primeren preventiven in popraven ukrep (sprememba izdelka, opozorila, umik iz obtoka, izdelek je potegnjen nazaj itd., odvisno od posebnih okoliščin).
General safety requirement and conformity criteria
Splošna varnostna zahteva in merila za skladnost
Producers and distributors must inform the competent authorities of the Member States if a product they have placed on the market poses a risk to consumers ‘that is incompatible with the general safety requirement’.
Proizvajalci in distributerji so dolžni obvestiti pristojne organe držav članic o izdelku, ki je bil dan v promet in predstavlja tveganje za potrošnike, ki „ni v skladu s splošno varnostno zahtevo“.
Producers are obliged to place only ‘safe’ products on the market.
Proizvajalci so obvezani dati v promet samo „varne“ izdelke.
Article 2(b) defines a safe product as one that under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons taking into account the following points in particular:
Varen izdelek iz člena 2(b) je opredeljen kot tak, ki v normalnih ali utemeljeno predvidljivih okoliščinah uporabe vključno z rokom trajanja, morebitno predajo v uporabo, namestitvijo in vzdrževanjem ne predstavlja nobenega tveganja ali minimalna tveganja v skladu z njegovo uporabo in velja za sprejemljivega in v skladu z visoko stopnjo zagotavljanja varnosti in zaščite zdravja potrošnikov ob upoštevanju zlasti naslednjih postavk:
the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;
značilnosti izdelka vključno z njegovo sestavo, embalažo, navodili za sestavljanje in, kjer je to možno, z navodili za namestitev in vzdrževanje;
the effect on other products, where it is reasonably foreseeable that it will be used with other products;
vpliv izdelka na druge izdelke, kjer je možno utemeljeno predvidevati, da bo uporabljen skupaj z drugimi izdelki;
the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product;
videz izdelka, označevanje, vsa opozorila in navodila za uporabo in reciklažo in vse druge označbe oziroma podatki, ki zadevajo izdelek;
the categories of consumers at risk when using the product, in particular children and the elderly.
kategorije potrošnikov, ki so izpostavljeni tveganju, ko izdelek uporabljajo, še zlasti otroci in starejše osebe.
The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be ‘dangerous’.
Izvedljivost doseganja višjih stopenj varnosti ali prisotnosti drugih izdelkov, ki predstavljajo nižjo stopnjo tveganja, ne sme tvoriti osnove za štetje izdelka za „nevarnega“.
Any product that does not meet this definition is regarded as dangerous (Article 2(c)). In other words, a product is ‘dangerous’ when it does not satisfy the general safety requirement (products on the market must be safe).
Izdelek, ki ne ustreza tej opredelitvi, je obravnavan kot nevaren izdelek (člen 2(c), z drugimi besedami, izdelek velja za „nevarnega“, kadar ne izpolnjuje osnovne varnostne zahteve (izdelki, dani v promet, morajo biti varni).
Article 3 GPSD describes how conformity is assessed with reference to national legislation, European standards and other reference material.
Člen 3 GPSD opisuje način ocenjevanja skladnosti ob upoštevanju nacionalne zakonodaje, evropskih standardov in drugega referenčnega gradiva.
Where suitable European standards do not exist, the GPSD allows other elements to be taken into account in assessing the safety of a product: national standards, codes of good practice, etc.
Kjer ni ustreznih evropskih standardov, GPSD za ocenjevanje varnosti izdelka dovoljuje upoštevanje drugih meril: nacionalne standarde, kodeks dobrega poslovanja idr.
In addition to the above, the Directive also refers to serious risk, which is defined in Article 2(d) as ‘any serious risk, including those the effects of which are not immediate, requiring rapid intervention by the public authorities’.
Poleg povedanega se Direktiva nanaša tudi na resno tveganje, ki je v členu 2(d) opredeljeno kot „kakršno koli resno tveganje vključno s takšnim, katerega posledice niso neposredno vidne in zahtevajo hitro posredovanje javnih organov.“
Nevertheless, the Directive recognises that the feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk do not constitute grounds for considering a product to be ‘dangerous’.
Direktiva kljub temu priznava, da izvedljivost doseganja višjih stopenj varnosti oziroma dostopnost podobnih izdelkov, ki predstavljajo nižjo stopnjo tveganja, ne tvori osnove za štetje izdelka za „nevarnega“.
The level of risk could depend on a number of factors such as for example the type and vulnerability of the user and the extent to which the producer had taken precautions to guard against the hazard and warn the user.
Stopnja tveganja je lahko odvisna od številnih dejavnikov, kot so na primer tipi uporabnikov, njihove šibke točke in obseg previdnostnih ukrepov, ki jih je proizvajalec uporabil, da se prepreči ogroženost uporabnika in se ga opozori.
It is considered that these factors should also be taken into account in determining the level of risk that is regarded as dangerous and requires producers to notify the competent authorities.
Poleg tega velja, da se ti dejavniki upoštevajo tudi pri določanju stopnje tveganja, ki velja za nevarno in zahteva od proizvajalcev, da o tem uradno obvestijo pristojne organe.
A risk could be the result of a manufacturing or production error or it could result from the design of, or the materials used in, the product.
Tveganje je lahko posledica napake v izdelavi ali v proizvodnem procesu oziroma oblikovanja ali v izdelku uporabljenega materiala.
A risk could also arise from a product's contents, construction, finish, packaging, warnings or instructions.
Prav tako so lahko razlog za tveganje vsebina izdelka, zgradba, površinska obdelava, embalaža, opozorila ali navodila.
In determining whether a product is dangerous under the terms of the GPSD several issues should be analysed: the utility of the product, the nature of the risk, the population groups exposed, previous experience with similar products, etc. A safe product must have no risk or only present the minimum risk compatible with the product's use and needed in order to ensure useful operation of the product.
Pri določanju, ali izdelek velja za nevarnega, je v okviru GPSD treba upoštevati številne dejavnike: uporabnost proizvoda, naravo tveganja, izpostavljene skupine prebivalstva, prejšnje izkušnje s podobnimi izdelki idr. Varen izdelek ne sme predstavljati nikakršnega ali zgolj minimalno tveganje v skladu z njegovo rabo in zagotavljanjem njegovega uporabnega delovanja.
Producers are expected to undertake a risk assessment of their products before they are marketed.
Od proizvajalcev se pričakuje, da izvedejo oceno tveganja za svoje izdelke, še preden jih dajo v promet.