natgillin/translations-raw huggingface dataset:
In the interests of competitiveness, it is crucial that notified bodies apply the modules without creating unnecessary burdens for economic operators.
Za namene konkurenčnosti je ključnega pomena, da priglašeni organi uporabljajo module brez nepotrebne obremenitve gospodarskih subjektov.
For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the modules must be ensured.
Iz istega razloga in za zagotovitev enake obravnave gospodarskih subjektov bi bilo treba zagotoviti usklajenost uporabe tehnične modulov.
That can best be achieved through appropriate coordination and cooperation between notified bodies.
To je mogoče doseči z ustreznim usklajevanjem in s sodelovanjem med priglašenimi organi.
To ensure the proper functioning of the certification process, certain procedures, such as exchanges of experience and information between notified bodies and notifying authorities and between notified bodies, should be consolidated.
Da se zagotovi ustrezno delovanje postopka certifikacije, je treba utrditi določene postopke, kot so izmenjave izkušenj in izmenjave informacij med priglašenimi organi in organi priglasitelji, prav tako pa tudi med samimi priglašenimi organi.
Community harmonisation legislation already provides for a safeguard procedure which applies only in the event of disagreement between Member States over measures taken by a Member State.
Usklajevalna zakonodaje Skupnosti vključuje varnostni postopek, ki se uporablja v primeru nestrinjanja med državami članicami o ukrepih, ki jih država članica izvaja.
In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard clause procedure, with a view to making it more efficient and drawing on the expertise available in Member States.
Da bi povečali preglednost in skrajšali čas postopka, je z namenom povečanja učinkovitosti in črpanja iz obstoječih izkušenj držav članic treba izboljšati postopke obstoječih zaščitnih klavzul.
The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to products presenting a risk to the health and safety of persons or to other aspects of public interest protection.
Obstoječi sistem bi bilo treba dopolniti s postopkom, ki omogoča zainteresiranim strankam, da so obveščene o bodočih ukrepih, ki so povezani s proizvodi, ki predstavljajo tveganje za zdravje in varnost ljudi ali druge javne interese.
It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such products.
Organom za nadzor trga naj bi omogočal, da v sodelovanju z ustreznimi gospodarskimi subjekti glede takih proizvodov prej ukrepajo.
Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard.
V primeru, da se države članice in Komisija strinjajo glede upravičenosti ukrepa, ki ga izvaja država članica, nadaljnje posredovanje Komisije ni potrebno, razen v primerih, kjer je neizpolnjevanje posledica pomanjkljivosti harmoniziranega standarda.
Community legislation should take account of the specific situation of small and medium-sized enterprises as regards administrative burdens.
Zakonodaja Skupnosti bi morala upoštevati poseben položaj malih in srednje velikih podjetij glede upravnih bremen.
However, rather than providing for general exceptions and derogations for such enterprises, which might imply that they or their products are second-rate or sub-quality and which might result in a complex legal situation for the national market surveillance authorities to supervise, Community legislation should provide for the situation of such enterprises to be taken into account in setting the rules for the selection and implementation of the most appropriate conformity assessment procedures and concerning the obligations placed on conformity assessment bodies to operate in a proportionate manner in relation to the size of undertakings and to the small serial or non-serial nature of the production concerned.
Vendar namesto, da bi za ta podjetja predvidela splošne izjeme in odstopanja, ki lahko nakazuje, da gre za drugorazredne ali manj kakovostne subjekte ali proizvode, in lahko pripeljejo do zapletene pravne ureditve za nacionalne organe za nadzor trga, s katero bo oteženo njihovo delo nadzora, bi moral biti položaj takšnih podjetij upoštevan s strani zakonodaje Skupnosti pri določitvi pravil za izbor in izvajanje najustreznejšega postopka za ugotavljanje skladnosti in v obveznostih organov za ugotavljanje skladnosti, da bodo delovali sorazmerno z velikostjo podjetja in glede na to, ali gre za serijsko ali posamično proizvodnjo.
This Decision provides the legislator with the flexibility necessary to take account of such a situation, without creating unnecessary specific and inappropriate solutions for small and medium-sized enterprises, and without compromising the protection of public interests.
Ta sklep omogoča zakonodajalcu potrebno prožnost pri upoštevanju takšnega položaja, ne da bi moral iskati nepotrebne, posebne in neprimerne rešitve za mala in srednje velika podjetja ter ne da bi ogrožal varstva javnega interesa.
This Decision establishes provisions for conformity assessment bodies to perform their functions, while taking into consideration the specific situation of small and medium-sized enterprises and respecting the degree of rigour and level of protection required for products to comply with the legislative instruments applicable to them.
Ta sklep določa določbe za organe za ugotavljanje skladnosti, ob upoštevanju posebnega položaja malih in srednje velikih podjetij ter ob spoštovanju ravni strogosti in zaščite, ki je potrebna za skladnost proizvodov z zakonodajnimi instrumenti, ki veljajo zanje.
Within one year of the publication of this Decision in the Official Journal of the European Union, the Commission should present an in-depth analysis in the field of consumer safety markings, followed by legislative proposals if necessary,
V enem letu po objavi tega sklepa v Uradnem listu Evropske unije mora Komisija predstaviti poglobljeno analizo področja označevanja varnosti potrošnikov in po potrebi tudi zakonodajne predloge,
Products placed on the Community market shall comply with all applicable legislation.
Proizvodi, ki so dani na trg Skupnosti, so v skladu z vso veljavno zakonodajo.
When placing products on the Community market, economic operators shall, in relation to their respective roles in the supply chain, be responsible for the compliance of their products with all applicable legislation.
Ob dajanju proizvodov na trg Skupnosti so gospodarski subjekti v povezavi z njihovo ustrezno vlogo v dobavni verigi odgovorni za skladnost proizvodov z vso veljavno zakonodajo.
Economic operators shall be responsible for ensuring that all information they provide with regard to their products is accurate, complete and in compliance with Community rules applicable.
Gospodarski subjekti so odgovorni za zagotovitev, da so vse informacije, ki jih priskrbijo o njihovih proizvodih, točne, popolne in v skladu z veljavnimi pravili Skupnosti.
This Decision sets out the common framework of general principles and reference provisions for the drawing up of Community legislation harmonising the conditions for the marketing of products (Community harmonisation legislation).
Ta sklep določa skupni okvir splošnih načel in referenčne določbe za pripravo zakonodaje Skupnosti, ki usklajuje pogoje za trženje proizvodov („usklajevalna zakonodaja Skupnosti“).
Community harmonisation legislation shall have recourse to the general principles set out in this Decision and to the relevant reference provisions of Annexes I, II and III.
Usklajevalna zakonodaja Skupnosti uporablja splošna načela, določena v tem sklepu, in ustrezne referenčne določbe iz prilog I, II in III.
However, Community legislation may depart from those general principles and reference provisions if that is appropriate on account of the specificities of the sector concerned, especially if comprehensive legal systems are already in place.
Vendar se zakonodaja Skupnosti lahko razlikuje od teh splošnih načel in referenčnih določb, če je to ustrezno zaradi posebnih značilnosti zadevnega sektorja, zlasti če že obstajajo celoviti pravni sistemi.
Level of protection of public interests
Raven zaščite javnih interesov
As regards the protection of public interests, Community harmonisation legislation shall restrict itself to setting out the essential requirements determining the level of such protection and shall express those requirements in terms of the results to be achieved.
Usklajevalna zakonodaja Skupnosti se na področju javnih interesov omejuje na določanje osnovnih zahtev, ki določajo raven omenjene zaščite, in izraža te interese v okviru rezultatov, ki jih je treba doseči.
Where recourse to essential requirements is not possible or not appropriate, in view of the objective of ensuring the adequate protection of consumers, public health and the environment or other aspects of public interest protection, detailed specifications may be set out in the Community harmonisation legislation concerned.
Če uporaba osnovnih zahtev ni možna ali ustrezna ob upoštevanju cilja za zagotavljanje ustreznega varstva potrošnikov, javnega zdravja in okolja ali drugih vidikov zaščite javnega interesa, je mogoče v zadevni usklajevalni zakonodaji Skupnosti določiti natančne specifikacije.
Where Community harmonisation legislation sets out essential requirements, it shall provide for recourse to be had to harmonised standards, adopted in accordance with Directive 98/34/EC, which shall express those requirements in technical terms and which shall, alone or in conjunction with other harmonised standards, provide for the presumption of conformity with those requirements, while maintaining the possibility of setting the level of protection by other means.
Če usklajevalna zakonodaja Skupnosti določa osnovne zahteve, mora določati tudi uporabo harmoniziranih standardov, sprejetih v skladu z Direktivo 98/34/ES, ki določa take zahteve v tehničnem smislu, in ki sami ali v povezavi z drugimi harmoniziranimi standardi zagotavljajo domnevo o skladnosti s takimi zahtevami, pri tem pa ohranjajo možnost določanja ravni zaščite z drugimi sredstvi.
Conformity assessment procedures
Postopki za ugotavljanje skladnosti
Where Community harmonisation legislation requires conformity assessment to be performed in respect of a particular product, the procedures which are to be used shall be chosen from among the modules set out and specified in Annex II, in accordance with the following criteria:
Če usklajevalna zakonodaja Skupnosti za določen proizvod zahteva ugotavljanje skladnosti, je treba postopke, ki se bodo izvajali, izbrati iz seznama modulov iz Priloge II v skladu z naslednjimi merili:
whether the module concerned is appropriate to the type of product;
primernost modula glede na vrsto proizvoda;
the nature of the risks entailed by the product and the extent to which conformity assessment corresponds to the type and degree of risk;
stopnja tveganja, ki jo prinaša proizvod, in stopnja, do katere ugotavljanje skladnosti ustreza vrsti in stopnji tveganja;
where third party involvement is mandatory, the need for the manufacturer to have a choice between quality assurance and product certification modules set out in Annex II;
v primerih, ko je sodelovanje tretje strani obvezno, potreba proizvajalca, da lahko izbira med zagotavljanjem kakovosti in moduli certifikacije proizvoda, kot določa Priloga II;
the need to avoid imposing modules which would be too burdensome in relation to the risks covered by the legislation concerned.
potreba po izogibanju vzpostavljanja modulov, ki bi povzročili preveliko obremenitev glede na tveganja, ki jih zajema zadevna zakonodaja.
Where a product is subject to several Community acts within the scope of this Decision, consistency among conformity assessment procedures shall be ensured by the legislator.
Če za proizvod velja več aktov Skupnosti v okviru tega sklepa, mora zakonodajalec zagotoviti skladnost med postopki za ugotavljanje skladnosti.
The modules referred to in paragraph 1 shall be applied as appropriate to the product concerned and in accordance with the instructions set out in those modules.
Module iz odstavka 1 je treba uporabljati ob upoštevanju zadevnega proizvoda in v skladu z navodili iz teh modulov.
For custom-made products and small series production, the technical and administrative conditions relating to conformity assessment procedures shall be alleviated.
Za proizvode, izdelane po naročilu, in proizvodnjo v omejenih serijah veljajo lažji tehnični in upravni pogoji v zvezi s postopki za ugotavljanje skladnosti.
When applying the modules referred to in paragraph 1, and wherever applicable and relevant, the legislative instrument may:
Pri uporabi modulov iz odstavka 1 in kjer je to potrebno in ustrezno, lahko zakonodajni instrument:
regarding technical documentation, require information additional to that which is already stipulated in the modules;
v zvezi s tehnično dokumentacijo zahteva dodatne informacije poleg tistih, ki so določene v modulih;
regarding the time for which the manufacturer and/or notified body are obliged to keep any kind of documentation, alter the period stipulated in the modules;
v zvezi z rokom, do katerega mora proizvajalec in/ali priglašeni organ hraniti vso dokumentacijo, spremeni dolžino obdobja, kot je predvideno v modulih;
specify the manufacturer's choice as to whether the tests are carried out either by an accredited in-house body or under the responsibility of a notified body chosen by the manufacturer;
podrobneje opredeli izbiro proizvajalca o tem, ali preskuse izvaja pooblaščeni interni organ ali pa je zanje odgovoren priglašeni organ, ki ga izbere proizvajalec;
where product verification is performed, specify the manufacturer's choice as to whether the examinations and tests to check the conformity of the products with the appropriate requirements will be carried out, by examination and testing of every product, or by examination and testing of the products on a statistical basis;
kjer se izvaja preverjanje proizvoda, opredeli izbiro proizvajalca glede izvedbe pregledov in preizkusov za pregled skladnosti proizvodov z ustreznimi zahtevami, in sicer ali s pregledom in preskušanjem vsakega proizvoda ali s pregledom in preskušanjem proizvodov na statistični podlagi;
provide for the EC-type examination certificate to have a period of validity;
certifikatu o ES-pregledu tipa določi čas veljavnosti;
regarding the EC-type examination certificate, specify relevant information relating to conformity assessment and in-service control to be included in it or its annexes;
glede certifikata o ES-pregledu tipa določi ustrezne informacije, da se ocena skladnosti in nadzor med uporabo lahko vključita v certifikat ali njegove priloge;
provide for different arrangements regarding the obligations of the notified body to inform its notifying authorities;
zagotovi različne ureditve glede obveznosti priglašenega organa za obveščanje svojih priglasitvenih organov;
if the notified body carries out periodic audits, specify their frequency.
če priglašeni organ izvaja redne revizije, določi, kako pogosto se izvajajo.
When applying the modules referred to in paragraph 1, and wherever applicable and relevant, the legislative instrument shall:
Pri uporabi modulov iz odstavka 1 in kjer je to potrebno in ustrezno, mora zakonodajni instrument:
where product checks and/or verification are performed, determine the products concerned, the appropriate tests, the adequate sampling schemes, the operational characteristics of the statistical method to be applied and the corresponding action to be taken by the notified body and/or the manufacturer;
pri izvajanju pregleda in/ali preverjanja proizvoda določiti zadevni proizvod, primerne preizkuse, ustrezne programe vzorčenja, operativne značilnosti statistične metode, ki jo je treba uporabiti, in ustrezne ukrepe, ki jih mora sprejeti priglašeni organ in/ali proizvajalec;
where EC-type examination is performed, determine the appropriate manner (design type, production type, design and production type) and the specimens required.
pri opravljanju ES-pregleda tipa določiti ustrezen način (tip proizvodnje, tip oblikovanosti, tip proizvodnje in oblikovanosti) ter potrebne vzorce.
An appeal procedure against decisions of the notified body shall be available.
Na voljo mora biti pritožbeni postopek proti sklepom priglašenega organa.
Where Community harmonisation legislation requires a statement by the manufacturer that fulfilment of the requirements relating to a product has been demonstrated (EC declaration of conformity), the legislation shall provide that a single declaration shall be drawn up in respect of all Community acts applicable to the product containing all information required for the identification of Community harmonisation legislation to which the declaration relates, and giving the publication references of the acts concerned.
Če usklajevalna zakonodaja Skupnosti zahteva izjavo proizvajalca o dokazu, da proizvod izpolnjuje pogoje („izjava ES o skladnosti“), zakonodaja zagotavlja, da se pripravi ena izjava, ki upošteva vse akte Skupnosti, veljavne za proizvod, in vsebuje vse informacije, potrebne za določitev usklajevalne zakonodaje Skupnosti, na katero se izjava nanaša, ter sklice na objavo zadevnih aktov.
Conformity assessment
Ugotavljanje skladnosti
Where Community harmonisation legislation requires conformity assessment, it may provide for that assessment to be carried out by public authorities, manufacturers or notified bodies.
Če usklajevalna zakonodaja Skupnosti zahteva ugotavljanje skladnosti, lahko določa, da ugotavljanje izvedejo javni organi, proizvajalci ali priglašeni organi.
Where Community harmonisation legislation provides for conformity assessment to be carried out by public authorities, the legislation shall provide that the conformity assessment bodies on which those authorities rely for technical assessments must comply with the same criteria as those set out in this Decision for notified bodies.
Če usklajevalna zakonodaja Skupnosti določa, da ugotavljanje skladnosti izvajajo javni organi, potem določa, da organi za ugotavljanje skladnosti, na katere se javni organi opirajo glede tehničnega ocenjevanja, morajo izpolnjevati enaka merila, kot so v tem sklepu določena za priglašene organe.
Reference provisions
Referenčne določbe
The reference provisions for Community harmonisation legislation for products shall be as set out in Annex I.
Referenčne določbe za usklajevalno zakonodajo Skupnosti za proizvode so navedene v Prilogi I.
Decision 93/465/EEC is hereby repealed.
Sklep 93/465/EGS se razveljavi.
References to the repealed Decision shall be construed as references to this Decision.
Sklicevanja na razveljavljen sklep se štejejo za sklicevanja na ta sklep.
OJ C 120, 16.5.2008, p. 1.
UL C 120, 16.5.2008, str. 1.
Opinion of the European Parliament of 21 February 2008 (not yet published in the Official Journal) and Council Decision of 23 June 2008.
Mnenje Evropskega parlamenta z dne 21. februarja 2008 (še ni objavljeno v Uradnem listu) in Sklep Sveta z dne 23. junija 2008.
OJ C 282, 25.11.2003, p. 3.
UL C 282, 25.11.2003, str. 3.
REFERENCE PROVISIONS FOR COMMUNITY HARMONISATION LEGISLATION FOR PRODUCTS
REFERENČNE DOLOČBE ZA USKLAJEVALNO ZAKONODAJO SKUPNOSTI ZA PROIZVODE
Chapter R1
Poglavje R1
Article R1
Člen R1
For the purposes of this ... [act] the following definitions shall apply:
Za namene [tega akta] se uporabljajo naslednje opredelitve pojmov:
‘making available on the market’ shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;
„dostopnost na trgu“ pomeni vsako dobavo proizvoda za distribucijo, porabo ali uporabo na trgu Skupnosti v okviru gospodarske dejavnosti, bodisi odplačno ali neodplačno;
‘placing on the market’ shall mean the first making available of a product on the Community market;
„dajanje na trg“ pomeni, da je proizvod prvič na voljo na trgu Skupnosti;
‘manufacturer’ shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark;
„proizvajalec“ pomeni vsako fizično ali pravno osebo, ki izdeluje proizvod ali za katero se tak proizvod načrtuje ali izdeluje in ki trži ta proizvod pod njegovim imenom ali blagovno znamko;
‘authorised representative’ shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
„pooblaščeni zastopnik“ pomeni vsako fizično ali pravno osebo s sedežem v Skupnosti, ki jo je proizvajalec pisno pooblastil, da v njegovem imenu izvaja določene naloge;
‘importer’ shall mean any natural or legal person established within the Community who places a product from a third country on the Community market;
„uvoznik“ pomeni vsako fizično ali pravno osebo s sedežem v Skupnosti, ki da proizvod iz tretje države na trg Skupnosti;
‘distributor’ shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;
„distributer“ pomeni vsako fizično ali pravno osebo v dobavni verigi, ki ni proizvajalec ali uvoznik in ki da proizvod na trg;
‘economic operators’ shall mean the manufacturer, the authorised representative, the importer and the distributor;
„gospodarski subjekti“ pomenijo proizvajalca, pooblaščenega zastopnika, uvoznika in distributerja;
‘technical specification’ shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service;
„tehnična specifikacija“ pomeni dokument, ki določa tehnične zahteve, ki jih mora izpolnjevati proizvod, proces ali storitev;
‘harmonised standard’ shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC on the basis of a request made by the Commission in accordance with Article 6 of that Directive;
„harmonizirani standard“ pomeni standard, ki ga je sprejel eden izmed evropskih organov za standardizacijo iz Priloge I k Direktivi 98/34/ES na podlagi predloga, ki ga je pripravila Komisija v skladu s členom 6 te direktive;
‘accreditation’ shall have the meaning assigned to it by Regulation (EC) No 765/2008;
„akreditacija“ ima pomen iz Uredbe (ES) št. 765/2008;
‘national accreditation body’ shall have the meaning assigned to it by Regulation (EC) No 765/2008;
„nacionalni akreditacijski organ“ ima pomen iz Uredbe (ES) št. 765/2008;
‘conformity assessment’ shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled;
„ugotavljanje skladnosti“ pomeni proces ugotavljanja, ali so posebne zahteve glede proizvoda, postopka, storitve, sistema, osebe ali organa izpolnjene;
‘conformity assessment body’ shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection;
„organ za ugotavljanje skladnosti“ pomeni organ, ki izvaja dejavnosti ugotavljanja skladnosti, vključno s kalibracijo, preskušanjem, potrjevanjem in pregledovanjem;
‘recall’ shall mean any measure aimed at achieving the return of a product that has already been made available to the end user;
„odpoklic“ pomeni vsak ukrep za vrnitev proizvoda, ki je že na voljo končnemu uporabniku;
‘withdrawal’ shall mean any measure aimed at preventing a product in the supply chain from being made available on the market;
„umik“ pomeni vsak ukrep za preprečitev dostopnosti proizvoda iz dobavne verige na trgu;