natgillin/translations-raw huggingface dataset:
Namestitev na proizvod znakov, označb ali napisov, ki bi lahko zavedli tretje stranke glede pomena ali oblike znaka CE ali obojega, je prepovedano.
The affixing on a product of markings, signs and inscriptions which are likely to mislead third parties as to the meaning or form of the CE marking , or both, is prohibited.
Namestitev na proizvod znakov, označb ali napisov, ki bi lahko zavedli trg glede pomena in oblike znaka CE, je prepovedana.
The affixing on a product of markings, signs and inscriptions which are likely to mislead the market as to the meaning and form of the CE marking is prohibited.
(a) izda izjavo, iz katere je razvidno, da se je prepričal, da je proizvajalec ali njegov pooblaščeni zastopnik opravil ustrezne postopke za ugotavljanje skladnosti ter da prevzema pravno odgovornost za proizvode, ki jih uvaža;
(a) issue a statement declaring that he has verified that the appropriate conformity assessment procedures have been carried out by the manufacturer or his authorised representatives and that he accepts legal responsibility for the products which he imports;
(b) obdrži in hrani izjavo ES o skladnosti, ki jo je pripravil proizvajalec ali njegov pooblaščeni zastopnik;
(b) keep and maintain the EC declaration of conformity prepared by the manufacturer or his authorised representative;
(c) obdrži in hrani kopijo tehnične dokumentacije, ki jo je pripravil proizvajalec ali njegov pooblaščeni zastopnik, v svojih prostorih ali v prostorih tretje osebe;
(c) keep and maintain a copy of the technical documentation prepared by the manufacturer or his authorised representative, either at his own premises or at the premises of a third party;
(d) hrani informacije, opisane v točkah (a), (b) in (c) za obdobje desetih let po izdelavi zadnje enote proizvoda…[ali za morebitno drugo določeno obdobje] ter jih na zahtevo predloži organom za nadzor trga.
(d) keep the information described in points (a), (b) and (c) for a period of ten years after the last product unit has been manufactured … [or such other period as may be specified] at the disposal of the market surveillance authorities.
Ta predlog spremembe velja tudi za naslednje module:
This amendment should apply also to the following modules:
Modul A1 – odstavek 6a novo
Module A1 – paragraph 6a new
Modul A2 – odstavek 6a novo
Module A2 – paragraph 6a new
Modul C – odstavek 4a novo
Module C – paragraph 4a new
Modul C1 – odstavek 5a novo
Module C1 – paragraph 5a new
Modul C2 – odstavek 5a novo
Module C2 – paragraph 5a new
Modul D – odstavek 8a novo
Module D – paragraph 8a new
Modul D1 – odstavek 10a novo
Module D1 – paragraph 10a new
Modul E – odstavek 8a novo
Module E – paragraph 8a new
Modul E1 – odstavek 10a novo
Module E1 – paragraph 10a new
Modul F – odstavek 8a novo
Module F – paragraph 8a new
Modul F1 – odstavek 9a novo
Module F1 – paragraph 9a new
Modul G – odstavek 6a novo
Module G – paragraph 6a new
Modul H – odstavek 8a novo
Module H – paragraph 8a new
Modul H1 – odstavek 8a novo
Module H1 – paragraph 8a new
Predlagani predlog spremembe je v skladu s predlogom spremembe k členu 9 o obveznostih uvoznikov.
This suggested amendment is in line with the one proposed to Article 9 on importers’ obligations.
o predlogu uredbe Evropskega parlamenta in Sveta o določitvi zahtev za akreditacijo in nadzor trga v zvezi s trženjem proizvodov
on the proposal for a regulation of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products
PE 390.753v01-00
PE 390.753v03-00
– ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2007)0037 ),
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2007)0037 ),
– ob upoštevanju člena 251(2) ter členov 95 in 133 pogodbe o ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C6-0068/2007 ),
– having regard to Article 251(2) and Articles 95 and 133 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6‑0068/2007 ),
– ob upoštevanju poročila Odbora za notranji trg in varstvo potrošnikov ter mnenj Odbora za mednarodno trgovino, Odbora za okolje, javno zdravje in varnost hrane ter Odbora za industrijo, raziskave in energetiko ( A6-0491/2007 ),
– having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinions of the Committee on International Trade, the Committee on the Environment, Public Health and Food Safety and the Committee on Industry, Research and Energy ( A6‑0491/2007 ),
(1) Za okrepitev splošnega okvira, ki zagotavlja, da proizvodi spoštujejo visoko stopnjo zaščite javnih interesov, kot je varovanje zdravja , je nujno oblikovati določena pravila in načela v zvezi z akreditacijo in nadzorom trga, ki so pomembni vidiki tega okvira.
(1) For the purpose of strengthening the overall framework ensuring that products respect a high level of protection of public interests, such as health and safety, it is necessary to establish certain rules and principles in relation to accreditation and market surveillance, which are important aspects of that framework.
(1) Za določitev splošnega okvira, ki zagotavlja, da proizvodi spoštujejo visoko stopnjo zaščite javnih interesov, kot so zdravje in varnost , varstvo potrošnikov in okolja, je nujno oblikovati določena pravila in načela v zvezi z akreditacijo in nadzorom trga, ki so pomembni vidiki tega okvira.
(1) For the purpose of establishing an overall framework ensuring that products respect a high level of protection of public interests, such as health and safety , protection of consumers and of the environment , it is necessary to establish certain rules and principles in relation to accreditation and market surveillance, which are important aspects of that framework.
S to uredbo vzpostavljeni skupni okvir za akreditacijo in nadzor trga ne bi smel vplivati na bistvena pravila obstoječe zakonodaje, v kateri so opredeljene določbe, ki jih je treba spoštovati zaradi varstva javnega interesa na področjih, kot so zdravje, varnost ter varstvo potrošnikov in okolja, ampak je namenjen krepitvi njihovega delovanja.
The overall framework for accreditation and market surveillance established by this Regulation should not impact on the substantive rules of existing legislation setting out the provisions to be observed for the purpose of protecting the public interest in areas such as health, safety and protection of consumers and of the environment, but aims at enhancing their operation.
(Ta predlog spremembe nadomesti predlog spremembe iz osnutka poročila)
(This AM replaces AM 1 from the Draft Report)
(2) Na to uredbo je treba gledati kot na del splošnega okvira, ki zagotavlja visoko raven varnosti proizvodov, kot je določeno v Sklepu …….
(2) This Regulation is to be seen as part of an overall framework ensuring a high level of safety of products as provided for in Decision ……. of the European Parliament and of the Council of ……. setting up a framework for the marketing of products.
(3) Uredba (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varno hrano in postopkih, ki zadevajo varno hrano in Uredba (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora z namenom zagotavljanja preverjanja skladnosti z zakonodajo o krmi in živilih ter z zahtevami v zvezi z zdravstvenim varstvom in zaščito živali že določata skupen in enoten režim o zadevah iz te uredbe.
(3) Regulation (EC) No 178/2002 of the European Parliament and the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety and Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules already lay down a common and uniform regime on matters covered by this Regulation.
Za primere, ki jih ureja živilska zakonodaja in zakonodaja o krmi se zato pravila, določena v tej uredbi, ne uporabljajo.
In cases governed by food law and feed law the rules laid down in this Regulation should not therefore apply.
Vendar se zaradi posebne narave akreditacijskih obveznosti iz Uredbe Sveta (ES) št. 509/2006 z dne 20. marca 2006 o zajamčenih tradicionalnih posebnostih kmetijskih proizvodov in živil, Uredbe Sveta (ES) št. 510/2006 z dne 20. marca 2006 o zaščiti geografskih označb in označb porekla za kmetijske proizvode in živila in [Uredbe Sveta (ES) št. […/…] z dne … o ekološki pridelavi in označevanju ekoloških proizvodov], je primerno, da se določbe te uredbe uporabljajo za namene navedenih akreditacijskih obveznosti.
However, given the specific nature of the accreditation obligations contained in Council Regulation (EC) No 509/2006 of 20 March 2006 on agricultural products and foodstuffs as traditional specialities guaranteed, Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs and [Council Regulation (EC) No […/…] of … on organic production and labelling of organic products], it is appropriate that the provisions of this Regulation should apply for the purposes of those accreditation obligations.
(3) Zelo težko je sprejeti zakonodajo Skupnosti za vsak obstoječi proizvod ali za proizvod, ki bo lahko še razvit; za obravnavo takih proizvodov je potreben široko zasnovan horizontalen zakonski okvir, ki bo odpravljal pravno praznino, zlasti dokler ne bo opravljena revizija obstoječe posebne zakonodaje, in dopolnjeval določbe obstoječe ali načrtovane posebne zakonodaje, zlasti da se zagotovi visoka raven varnosti in zdravja potrošnikov, kakor to zahteva člen 95 pogodbe.
(3) It is very difficult to adopt Community legislation for every product which exists or which may be developed; there is a need for a broad-based, legislative framework of a horizontal nature to deal with such products, and also to cover lacunae, in particular pending revision of the existing specific legislation, and to complement provisions in existing or forthcoming specific legislation, in particular with a view to ensuring a high level of protection of health, safety, the environment and consumers, as required by Article 95 of the Treaty.
(Ta predlog spremembe nadomesti predlog spremembe 2 iz osnutka poročila)
(This AM replaces AM 2 from the Draft Report)
(3a) V nadaljevanju določeni okvir za nadzor trga mora dopolniti in okrepiti obstoječe določbe v zvezi z nadzorom trga v drugih predpisih Skupnosti.
(3a) The framework for market surveillance established hereunder should complement and strengthen existing provisions relating to market surveillance in other Community rules.
Vendar se mora v skladu z načelom lex specialis ta uredba uporabljati le, kadar ni posebnih določb z istim ciljem v obstoječih ali prihodnjih predpisih zakonodaje Skupnosti, kot je Direktiva 2001/95/ES Evropskega parlamenta in Sveta z dne 3. decembra 2001 o splošni varnosti proizvodov 1 .
However, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective as those established hereby in other, existing or future, rules of Community law, such as Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety 1 .
(1) UL L 11, 15.1.2002, str.
(1) OJ L 11, 15.1.2002, p.
(Ta sporazumni predlog spremembe 1 nadomesti predloga sprememb 115 in 116)
(This Compromise AM 1 replaces AMs 115 and 116)
(3b) Vendar, da bi dosegli višjo stopnjo varnosti potrošniških proizvodov, je treba okrepiti mehanizme nadzora trga iz direktive 2001/95/ES v zvezi s proizvodi, ki predstavljajo resno nevarnost, v skladu z istimi načeli, kot so določena v tej uredbi.
(3b) However, in order to achieve a higher level of safety for consumer products, the market surveillance mechanisms provided for in Directive 2001/95/EC should be reinforced as regards products presenting a serious risk, in accordance with the same principles as those established in this Regulation.
Direktivo 2001/95/ES je zato treba ustrezno spremeniti.
Directive 2001/95/EC should therefore be amended accordingly.
(4) Zaradi njihove posebne narave je treba tobačne izdelke iz Direktive 2001/37/ES Evropskega parlamenta in Sveta z dne 5. junija 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi s proizvodnjo, predstavitvijo in prodajo tobačnih izdelkov izloči iz te uredbe.
(4) Due to their specific nature, tobacco products under Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of laws, regulations and administrative provisions of the Member States concerning manufacture, presentation and sale of tobacco products should be excluded from this Regulation.
Treba bi bilo preprečiti dolg seznam izjem, ki ne pripomorejo k lažjemu razumevanju načel boljše pravne ureditve in bi v prihodnosti lahko zahtevale pogoste revizije uredbe.
Cumbersome lists of exceptions that do not further understanding or principles of better regulation and may necessitate frequent revisions of the Regulation in future should be avoided.
(5) Direktiva 2002/98/ES Evropskega parlamenta in Sveta z dne 27. januarja 2003 o določitvi standardov kakovosti in varnosti za zbiranje, preskušanje, predelavo, shranjevanje in razdeljevanje človeške krvi in komponent krvi ter o spremembi Direktive 2001/83/ES ter Direktiva 2004/23/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o določitvi standardov kakovosti in varnosti, darovanja, pridobivanja, testiranja, predelave, konzerviranja, shranjevanja in razdeljevanja človeških tkiv in celic določata skupen režim za tam zajete proizvode, ki zato ne smejo biti predmet te uredbe.
(5) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, and Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, lay down a common regime for the products covered therein, which should not therefore be subject to this Regulation.
Glej obrazložitev uvodne izjave 4.
See justification to recital 4.
(6a) Ustanovitev enotnega nacionalnega akreditacijskega organa ne vpliva na razdelitev nalog v državah članicah.
(6a) The establishment of a uniform national accreditation body shall be without prejudice to the allocation of functions within Member States.
(10) Uredba (ES) št. 761/2001 Evropskega parlamenta in Sveta z dne 19. marca 2001 o prostovoljnem sodelovanju organizacij v sistemu Skupnosti za okoljsko ravnanje in presojo (EMAS) vzpostavlja sistem za akreditacijo neodvisnih okoljskih preveriteljev in za nadzorovanje njihovih dejavnosti.
(10) Regulation (EC) No 761/2001 of the European Parliament and of the Council of 19 March 2001 allowing voluntary participation by organisations in a Community eco-management and audit schemes ( EMAS ) established a system for the accreditation of independent environmental verifiers and for the supervision of their activities.
Ker se pravila za ta sistem razlikujejo od določb te uredbe, je primere, ki jih ureja Uredba (ES) št. 761/2001, treba izločiti iz področja uporabe te uredbe.
Since the rules covering that system differ from the provisions of this Regulation, cases governed by Regulation (EC) No 761/2001 should be excluded from the scope of this Regulation.
(14) V primerih, kjer ni ekonomsko smiselno ali zdržno, da država članica ustanovi nacionalni akreditacijski organ, mora omenjena država članica imeti možnost uporabe nacionalnega akreditacijskega organa druge države članice.
(14) In those cases where it is not economically meaningful or sustainable for a Member State to establish a national accreditation body, that Member State should have the possibility of having recourse to the national accreditation body of another Member State.
V primerih, kjer ni ekonomsko smiselno ali zdržno, da država članica ustanovi nacionalni akreditacijski organ, bi omenjena država članica morala uporabiti nacionalni akreditacijski organ druge države članice in jo je treba spodbuditi, da izkoristi to možnost v čim večjem možnem obsegu .
(14) In those cases where it is not economically meaningful or sustainable for a Member State to establish a national accreditation body, that Member State should have recourse to the national accreditation body of another Member State and should be encouraged to avail itself of that opportunity to the fullest extent possible .
(Ta predlog spremembe nadomesti predlog spremembe 6 iz osnutka poročila)
(This AM replaces AM 6 from the Draft Report)
Države članice je treba spodbujati močneje kot v predlogu, da uporabljajo storitve akreditacijskega organa druge države članice, kjer je to primerno.
Member States should be encouraged more strongly than in the proposal to use the services of the accreditation body of another Member State where relevant.
(15) Da se prepreči podvajanje akreditacije in poveča sprejemanje in priznavanje potrdil o akreditaciji ter izvaja učinkovito spremljanje pooblaščenih organov za ugotavljanje skladnosti, organi za ugotavljanje skladnosti načeloma morajo zaprositi za akreditacijo pri nacionalnem akreditacijskem organu države članice, v kateri imajo sedež.
(15) In order to avoid duplication of accreditation and to enhance acceptance and recognition of accreditation certificates as well as to perform effective monitoring of accredited conformity assessment bodies, the conformity assessment bodies should in principle request accreditation by the national accreditation body of the Member State in which they are established.
Kljub temu je treba zagotoviti, da ima organ za ugotavljanje skladnosti možnost zaprositi za akreditacijo v drugi državi članici, kadar v njegovi državi članici ni nacionalnega akreditacijskega organa ali kadar tak organ ni usposobljen za opravljanje zahtevanih storitev akreditacije.
Nevertheless, it is necessary to ensure that a conformity assessment body has the possibility to request accreditation in another Member State in cases where in its Member State there is no national accreditation body or where such body is not competent to provide the requested accreditation services.
V takih primerih je treba vzpostaviti ustrezno sodelovanje in izmenjavo informacij med nacionalnimi akreditacijskimi organi.
In these cases, appropriate co-operation and exchange of information between national accreditation bodies should be established.
(15) Da se prepreči podvajanje akreditacije in poveča sprejemanje in priznavanje potrdil o akreditaciji ter izvaja učinkovito spremljanje pooblaščenih organov za ugotavljanje skladnosti, organi za ugotavljanje skladnosti morajo zaprositi za akreditacijo pri nacionalnem akreditacijskem organu države članice, v kateri imajo sedež.
(15) In order to avoid duplication of accreditation and to enhance acceptance and recognition of accreditation certificates as well as to perform effective monitoring of accredited conformity assessment bodies, the conformity assessment bodies should request accreditation by the national accreditation body of the Member State in which they are established.
Črtano, ker je nepotrebno.
Deleted as unnecessary.
(16) Da se zagotovi, da nacionalni akreditacijski organi izpolnjujejo zahteve in obveznosti iz te uredbe, je pomembno, da države članice podpirajo pravilno delovanje akreditacijskega sistema, izvajajo redno spremljanje svojih nacionalnih akreditacijskih organov in po potrebi sprejmejo ustrezne korektivne ukrepe.
(16) In order to ensure that national accreditation bodies fulfil the requirements and obligations under this Regulation, it is important that Member States support the proper functioning of the accreditation system, perform regular monitoring of their national accreditation bodies and take appropriate corrective measures where necessary.
(16) Da se zagotovi, da nacionalni akreditacijski organi izpolnjujejo zahteve in obveznosti iz te uredbe, je pomembno, da države članice podpirajo pravilno delovanje akreditacijskega sistema, izvajajo redno spremljanje svojih nacionalnih akreditacijskih organov in po potrebi v razumnem času sprejmejo ustrezne korektivne ukrepe.
(16) In order to ensure that national accreditation bodies fulfil the requirements and obligations under this Regulation, it is important that Member States support the proper functioning of the accreditation system, perform regular monitoring of their national accreditation bodies and take appropriate corrective measures within a reasonable timeframe where necessary.
Glej obrazložitev člena 5(3).
See justification to Article 5(3).
(18) Glavno poslanstvo Evropskega združenja za akreditacijo (EA) je spodbujati pregleden in kakovostno voden sistem za vrednotenje usposobljenosti organov za ugotavljanje skladnosti po vsej Evropi .
(18) The main mission of the European co-operation for Accreditation (EA) is to further a transparent and quality led system to evaluate the competence of conformity assessment bodies throughout Europe .
EA upravlja sistem strokovnega vrednotenja med nacionalnimi akreditacijskimi organi iz držav članic in drugih evropskih držav.
The EA is managing a peer evaluation system among national accreditation bodies from the Member States and other European countries.
Izkazalo se je, da je ta sistem učinkovit in zagotavlja vzajemno zaupanje.
That system has proved to be efficient and to provide mutual confidence.
Zato morajo države članice poskrbeti, da si bodo njihovi nacionalni akreditacijski organi prizadevali za članstvo v EA ali ga ohranili .
Therefore, Member States should ensure that their national accreditation bodies seek or maintain membership in the EA.
(18) Medtem ko mora ta uredba zagotoviti priznanje drugega organa glede nekaterih nalog v zvezi z akreditacijo, Evropsko združenje za akreditacijo (EA), katerega glavno poslanstvo je spodbujati pregleden in kakovostno voden sistem za vrednotenje usposobljenosti organov za ugotavljanje skladnosti po vsej Evropi, upravlja sistem strokovnega vrednotenja med nacionalnimi akreditacijskimi organi iz držav članic in drugih evropskih držav.
(18) While this Regulation should provide for the recognition of another body in respect of certain functions in the area of accreditation, the European co-operation for Accreditation (EA), whose main mission is to further a transparent and quality led system to evaluate the competence of conformity assessment bodies throughout Europe, is managing a peer evaluation system among national accreditation bodies from the Member States and other European countries.
Zato bi EA moral biti organ, ki se prvotno prizna v tej uredbi, države članice pa bi morale poskrbeti, da si njihovi nacionalni akreditacijski organi prizadevajo za članstvo v EA in ga ohranijo , dokler bo ta organ priznan.
Therefore, the EA should be the body initially recognised under this Regulation and Member States should ensure that their national accreditation bodies seek and maintain membership in the EA for as long as it is so recognised .
Istočasno je treba zagotoviti možnost spremembe priznanja zadevnega organa, če bo to potrebno v prihodnosti.
At the same time, the possibility for a change in recognition of the relevant body should be provided for, in case there is a need for it in the future.
(Ta predlog spremembe nadomesti predlog spremembe 9 iz osnutka poročila)
(This AM replaces AM 9 from the Draft Report)
EA zdaj lahko zagotovi storitve iz uredbe in mora biti organ, ki je prvotno priznan za ta namen, vendar se v prihodnje lahko oblikujejo drugi organi ali pa se EA lahko spremeni.
The EA is now in a position to provide services under the Regulation, and should be the body initially recognised for that purpose, but other bodies may develop in future or the EA might change.