natgillin/translations-raw huggingface dataset:
For monomers that are used as on-site isolated intermediates or transported isolated intermediates, Articles 17 and 18 shall not apply.
Za monomere, ki se uporabljajo kot na mestu izolirani intermediati ali prepeljani izolirani intermediati, se člena 17 in 18 ne uporabljata.
Any manufacturer or importer of a polymer shall submit a registration to the Agency for the monomer substance(s) or any other substance(s), that have not already been registered by an actor up the supply chain, if both the following conditions are met:
Vsak proizvajalec ali uvoznik polimera predloži Agenciji registracijo monomerne(-ih) snovi ali druge(-ih) snovi, ki jih udeleženec po dobavni verigi navzgor še ni registriral, če sta izpolnjena oba naslednja pogoja:
the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s);
polimer vsebuje 2 % mas. m/m ali več takšne(-ih) monomerne(-ih) ali druge(-ih) snovi v obliki monomernih enot in kemijsko vezane(-ih) snovi;
the total quantity of such monomer substance(s) or other substance(s) makes up one tonne or more per year.
skupna količina takšne(-ih) monomerne(-ih) ali druge(-ih) snovi znaša eno tono ali več na leto.
A submission for registration shall be accompanied by the fee required in accordance with Title IX.
Ob predložitvi registracije se plača pristojbina v skladu z naslovom IX.
Registration and notification of substances in articles
Registracija in prijava snovi v izdelkih
Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met:
Izdelovalec ali uvoznik izdelkov predloži Agenciji registracijo vseh snovi, ki jih vsebujejo ti izdelki, če so izpolnjeni vsi naslednji pogoji:
the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
ti izdelki vsebujejo snov v količini, ki znaša skupaj več kot eno tono na leto na izdelovalca ali uvoznika;
the substance is intended to be released under normal or reasonably foreseeable conditions of use.
snov naj bi se sprostila pod običajnimi ali razumno predvidljivimi pogoji uporabe.
Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met:
Izdelovalec ali uvoznik izdelkov prijavi pri Agenciji v skladu z odstavkom 4 tega člena, če snov izpolnjuje kriterije iz člena 57 in je opredeljena v skladu s členom 59(1), če sta izpolnjena naslednja pogoja:
the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).
ti izdelki vsebujejo snov v količini, ki je višja od koncentracije 0,1 % mas. m/m.
Paragraph 2 shall not apply where the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal.
Odstavek 2 se ne uporablja, kjer izdelovalec ali uvoznik lahko izključi možnost izpostavljenosti ljudi ali okolja pod normalnimi ali razumno predvidljivimi pogoji uporabe, vključno pri odstranjevanju.
In such cases, the producer or importer shall supply appropriate instructions to the recipient of the article.
V takih primerih izdelovalec ali uvoznik priskrbi prejemniku izdelka ustrezna navodila.
The information to be notified shall include the following:
Sporočene informacije morajo vsebovati:
the identity and contact details of the producer or importer as specified in section 1 of Annex VI, with the exception of their own use sites;
podatke o izdelovalcu ali uvozniku ter podatke za vzpostavitev stika z njim, kakor je določeno v oddelku 1 Priloge VI, razen njihovih mest uporabe;
the registration number(s) referred to in Article 20(1), if available;
številko(-e) registracije (registracij) iz člena 20(1), če je (so) na voljo;
the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI;
identiteto(-e) o snovi(-eh) v skladu z oddelki 2.1 do 2.3.4 Priloge VI;
the classification of the substance(s) as specified in sections 4.1 and 4.2 of Annex VI;
razvrstitev snovi, kakor je določeno v oddelkih 4.1 in 4.2 Priloge VI;
a brief description of the use(s) of the substance(s) in the article as specified in section 3.5 of Annex VI and of the uses of the article(s);
kratek opis uporabe (uporab) snovi, vsebovane v izdelku, kakor je določeno v oddelku 3.5 Priloge VI ter uporab izdelka(-ov);
the tonnage range of the substance(s), such as 1 to 10 tonnes, 10 to 100 tonnes and so on.
količinski razpon snovi, kot na primer od 1 do 10 ton, od 10 do 100 ton itd.
The Agency may take decisions requiring producers or importers of articles to submit a registration, in accordance with this Title, for any substance in those articles, if all the following conditions are met:
Agencija lahko sprejme odločitev, da od izdelovalcev ali uvoznikov izdelkov zahteva, da v skladu s tem naslovom predložijo registracijo za vse snovi v teh izdelkih, če so izpolnjeni vsi naslednji pogoji:
the Agency has grounds for suspecting that:
Agencija lahko utemeljeno domneva, da:
the substance is released from the articles, and
se snov sprošča iz izdelkov; in
the release of the substance from the articles presents a risk to human health or the environment;
sprostitev snovi iz izdelkov predstavlja tveganje za zdravje ljudi ali za okolje;
the substance is not subject to paragraph 1.
za snov ne velja odstavek 1.
Paragraphs 1 to 5 shall not apply to substances that have already been registered for that use.
Odstavki 1 do 5 se ne uporabljajo za snovi, ki so za to uporabo že bile registrirane.
From 1 June 2011 paragraphs 2, 3 and 4 of this Article shall apply six months after a substance is identified in accordance with Article 59(1).
Od 1. junija 2011 se odstavki 2, 3 in 4 uporabljajo šest mesecev po določitvi snovi v skladu s členom 59(1).
Any measures for the implementation of paragraphs 1 to 7 shall be adopted in accordance with the procedure referred to in Article 133(3).
Vsi ukrepi za izvajanje odstavkov 1 do 7 se sprejmejo v skladu s postopkom iz člena 133(3).
Only representative of a non-Community manufacturer
Edini zastopnik proizvajalca, ki nima sedeža v Skupnosti
A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers under this Title.
Fizična ali pravna oseba s stalnim bivališčem oziroma sedežem zunaj Skupnosti, ki proizvaja snov kot tako, v pripravkih ali izdelkih, formulira pripravek ali izdeluje izdelek, ki se uvaža v Skupnost, lahko sporazumno imenuje fizično ali pravno osebo s stalnim bivališčem oziroma sedežem v Skupnosti, da kot njen edini zastopnik izpolnjuje obveznosti uvoznikov iz tega naslova.
The representative shall also comply with all other obligations of importers under this Regulation.
Zastopnik izpolnjuje tudi vse druge obveznosti uvoznikov iz te uredbe.
To this end, he shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 36, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31.
Zato mora imeti zadostne izkušnje s področja praktičnega ravnanja s snovmi in informacije o njih, brez poseganja v člen 36 pa mora dati na razpolago in sproti posodabljati informacije o uvoženih količinah in kupcih, katerim so bile te prodane, ter podatke o dobavi iz varnostnega lista, prilagojenega zadnjemu stanju, iz člena 31.
If a representative is appointed in accordance with paragraphs 1 and 2, the non-Community manufacturer shall inform the importer(s) within the same supply chain of the appointment.
Če se zastopnik imenuje v skladu z odstavkoma 1 in 2, proizvajalec, ki nima sedeža v Skupnosti, o imenovanju obvesti uvoznika(-e) iz iste dobavne verige.
These importers shall be regarded as downstream users for the purposes of this Regulation.
Ti uvozniki se za namene te uredbe štejejo za nadaljnje uporabnike.
Exemption from the general obligation to register for product and process orientated research and development (PPORD)
Izvzetje iz splošne obveznosti registriranja za v proizvod in proces usmerjene raziskave in razvoj (PPORD)
Articles 5, 6, 7, 17, 18 and 21 shall not apply for a period of five years to a substance manufactured in the Community or imported for the purposes of product and process orientated research and development by a manufacturer or importer or producer of articles, by himself or in cooperation with listed customers and in a quantity which is limited to the purpose of product and process orientated research and development.
Členi 5, 6, 7, 17, 18 in 21 se pet let ne uporabljajo za snov, ki jo v Skupnosti proizvede ali vanjo uvozi za namene v proizvod in proces usmerjenih raziskav in razvoja proizvajalec ali uvoznik ali izdelovalec izdelkov sam ali v sodelovanju z navedenimi kupci in v količini, ki je omejena za namene v proizvod in proces usmerjenih raziskav in razvoja.
For the purpose of paragraph 1, the manufacturer or importer or producer of articles shall notify the Agency of the following information:
Za namen odstavka 1 proizvajalec ali uvoznik ali izdelovalec izdelkov Agenciji sporoči naslednje informacije:
the identity of the manufacturer or importer or producer of articles as specified in section 1 of Annex VI;
podatke o proizvajalcu ali uvozniku ali izdelovalcu izdelkov, kakor je določeno v oddelku 1 Priloge VI;
the identity of the substance, as specified in section 2 of Annex VI;
identiteto snovi, kakor je določeno v oddelku 2 Priloge VI;
the classification of the substance as specified in section 4 of Annex VI, if any;
razvrstitev snovi, če obstaja, kakor je določeno v oddelku 4 Priloge VI;
the estimated quantity as specified in section 3.1 of Annex VI;
ocenjeno količino, kakor je določeno v oddelku 3.1 Priloge VI;
the list of customers referred to in paragraph 1, including their names and addresses.
seznam kupcev iz odstavka 1 ter njihova imena in naslove.
The notification shall be accompanied by the fee required in accordance with Title IX.
Ob prijavi se plača pristojbina v skladu z naslovom IX.
The period set out in paragraph 1 shall begin at receipt of the notification at the Agency.
Obdobje iz odstavka 1 začne teči, ko Agencija prejme prijavo.
The Agency shall check the completeness of the information supplied by the notifier and Article 20(2) shall apply adapted as necessary.
Agencija preveri, ali so informacije, ki jih sporoči prijavitelj, popolne, in uporabi se po potrebi prilagojen člen 20(2).
The Agency shall assign a number to the notification and a notification date, which shall be the date of receipt of the notification at the Agency, and shall forthwith communicate that number and date to the manufacturer, or importer, or producer of articles concerned.
Agencija prijavi dodeli številko in datum prijave, ki je datum prejema prijave, ter ju takoj sporoči zadevnemu proizvajalcu ali uvozniku ali izdelovalcu izdelkov.
The Agency shall also communicate this information to the competent authority of the Member State(s) concerned.
Agencija te informacije sporoči tudi pristojnim organom zadevnih držav članic.
The Agency may decide to impose conditions with the aim of ensuring that the substance or the preparation or article in which the substance is incorporated will be handled only by staff of listed customers as referred to in paragraph 2(e) in reasonably controlled conditions, in accordance with the requirements of legislation for the protection of workers and the environment, and will not be made available to the general public at any time either on its own or in a preparation or article and that remaining quantities will be re-collected for disposal after the exemption period.
Agencija se lahko odloči za uvedbo pogojev, s katerimi zagotovi, da s snovjo, pripravkom ali izdelkom, ki vsebuje snov, ravna samo osebje navedenih kupcev v skladu z odstavkom 2(e) v razumno nadzorovanih pogojih in v skladu z zakonskimi zahtevami v zvezi z zaščito delavcev in okolja, ter da snov kot taka niti v pripravku ali izdelku nikoli ne bo dana na razpolago širši javnosti in se bodo preostale količine po preteku obdobja izvzetja ponovno zbrale zaradi odstranitve.
In such cases, the Agency may ask the notifier to provide additional necessary information.
V takšnih primerih lahko Agencija zahteva od prijavitelja, da priskrbi dodatne potrebne informacije.
In the absence of any indication to the contrary, the manufacturer or importer of the substance or the producer or importer of articles may manufacture or import the substance or produce or import the articles not earlier than two weeks after the notification.
Če ni navedeno drugače, proizvajalec ali uvoznik snovi ali izdelovalec ali uvoznik izdelkov ne sme proizvesti ali uvoziti snovi ali izdelati ali uvoziti izdelkov prej kot v dveh tednih po prijavi.
The manufacturer or importer or producer of articles shall comply with any conditions imposed by the Agency in accordance with paragraph 4.
Proizvajalec ali uvoznik ali izdelovalec izdelkov upošteva vse pogoje, ki jih postavi Agencija v skladu z odstavkom 4.
The Agency may decide to extend the five-year exemption period by a further maximum of five years or, in the case of substances to be used exclusively in the development of medicinal products for human or veterinary use, or for substances that are not placed on the market, for a further maximum of ten years, upon request if the manufacturer or importer or producer of articles can demonstrate that such an extension is justified by the research and development programme.
Agencija se lahko odloči, da na zahtevo petletno obdobje izvzetja podaljša za največ dodatnih pet let, v primeru snovi, namenjenih izključno razvoju zdravil za humano in veterinarsko uporabo, ali snovi, ki niso dane na trg, pa za največ dodatnih deset let, če lahko proizvajalec, uvoznik ali izdelovalec izdelkov na podlagi raziskovalnega in razvojnega programa dokaže, da je takšno podaljšanje upravičeno.
The Agency shall forthwith communicate any draft decisions to the competent authorities of each Member State in which the manufacture, import, production or product and process orientated research takes place.
Agencija vse osnutke odločitev sporoči pristojnim organom posameznih držav članic, v katerih potekajo proizvodnja, uvoz, izdelava ali v proizvode in procese usmerjene raziskave.
When taking decisions as provided for in paragraphs 4 and 7, the Agency shall take into account any comments made by such competent authorities.
Pri sprejetju odločitev v skladu z odstavkoma 4 in 7 Agencija upošteva vse pripombe teh pristojnih organov.
The Agency and the competent authorities of the Member States concerned shall always keep confidential the information submitted in accordance with paragraphs 1 to 8.
Agencija in pristojni organi zadevnih držav članic vedno obravnavajo vse informacije, predložene v skladu z odstavki 1 do 8, kot zaupne.
An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraphs 4 and 7 of this Article.
Proti odločitvam Agencije iz odstavkov 4 in 7 tega člena se lahko vloži pritožba v skladu s členi 91, 92 in 93.
Information to be submitted for general registration purposes
Informacije, ki se predložijo za splošno registracijo
A registration required by Article 6 or by Article 7(1) or (5) shall include all the following information:
Registracija, ki se zahteva na podlagi člena 6 ali člena 7(1) ali (5), vsebuje vse naslednje informacije:
a technical dossier including:
tehnično dokumentacijo, ki zajema:
the identity of the manufacturer(s) or importer(s) as specified in section 1 of Annex VI;
podatke o proizvajalcu(-ih) ali uvozniku(-ih), kakor je določeno v oddelku 1 Priloge VI;
the identity of the substance as specified in section 2 of Annex VI;
identiteto snovi, kakor je določeno v oddelku 2 Priloge VI;
information on the manufacture and use(s) of the substance as specified in section 3 of Annex VI; this information shall represent all the registrant's identified use(s).
informacije o proizvodnji in uporabi(-ah) snovi, kakor je določeno v oddelku 3 Priloge VI; te informacije vključujejo vse navedene uporabe registracijskega zavezanca.
This information may include, if the registrant deems appropriate, the relevant use and exposure categories;
Če registracijski zavezanec meni, da je to primerno, lahko te informacije vključujejo ustrezno kategorijo uporabe in izpostavljenosti;
the classification and labelling of the substance as specified in section 4 of Annex VI;
razvrstitev in označitev snovi, kakor je določeno v oddelku 4 Priloge VI;
guidance on safe use of the substance as specified in Section 5 of Annex VI;
navodila za varno uporabo snovi, kakor je določeno v oddelku 5 Priloge VI;
study summaries of the information derived from the application of Annexes VII to XI;
povzetke študij za informacije, ki izhajajo iz uporabe prilog VII do XI;
robust study summaries of the information derived from the application of Annexes VII to XI, if required under Annex I;
grobe povzetke študij za informacije, ki izhajajo iz uporabe prilog VII do XI, če se zahtevajo v skladu s Prilogo I;
an indication as to which of the information submitted under (iii), (iv), (vi), (vii) or subparagraph (b) has been reviewed by an assessor chosen by the manufacturer or importer and having appropriate experience;
navedbo, katere informacije, predložene v skladu s (iii), (iv), (vi), (vii) ali pododstavkom (b), je preveril ocenjevalec, ki ga je izbral proizvajalec ali uvoznik in ki ima ustrezne izkušnje;
proposals for testing where listed in Annexes IX and X;
predloge za testiranje, kjer je to navedeno v prilogah IX in X;
for substances in quantities of 1 to 10 tonnes, exposure information as specified in section 6 of Annex VI;
podatke o izpostavljenosti za snovi v količinah 1 do 10 ton, kakor je določeno v oddelku 6 Priloge VI;
a request as to which of the information in Article 119(2) the manufacturer or importer considers should not be made available on the Internet in accordance with Article 77(2)(e), including a justification as to why publication could be harmful for his or any other concerned party's commercial interests.
zahtevek glede informacij iz člena 119(2), za katere proizvajalec ali uvoznik meni, da naj ne bi bile na voljo na spletu v skladu s členom 77(2)(e), vključno z utemeljitvijo, zakaj naj bi objava škodila njegovim poslovnim interesom ali interesom katere koli zadevne strani.
Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (vi) and (vii) for the purpose of registration;
Razen v primerih iz členov 25(3), 27(6) ali 30(3), registracijski zavezanec zakonito razpolaga s celovitim poročilom o študiji ali ima dovoljenje za sklicevanje na celovito poročilo o študiji, povzeto v točkah (vi) in (vii) za namene registracije;
a chemical safety report when required under Article 14, in the format specified in Annex I. The relevant sections of this report may include, if the registrant considers appropriate, the relevant use and exposure categories.
poročilo o kemijski varnosti, če se to zahteva v skladu s členom 14, v obliki določeni v Prilogi I. Zadevni oddelki tega poročila lahko vključujejo, če registracijski zavezanec meni, da je to primerno, kategorijo uporabe in izpostavljenosti.
Joint submission of data by multiple registrants
Skupna predložitev podatkov, ki jo opravi več registracijskih zavezancev
When a substance is intended to be manufactured in the Community by one or more manufacturers and/or imported by one or more importers, and/or is subject to registration under Article 7, the following shall apply.
Če naj bi snov v Skupnosti proizvajal eden ali več proizvajalcev in/ali uvažal eden ali več uvoznikov ter/ali če jo je treba v skladu s členom 7 registrirati, se uporablja naslednje:
Subject to paragraph 3, the information specified in Article 10(a)(iv), (vi), (vii) and (ix), and any relevant indication under Article 10(a)(viii) shall first be submitted by the one registrant acting with the agreement of the other assenting registrant(s) (hereinafter referred to as the lead registrant).
Ob upoštevanju odstavka 3, informacije, navedene v členu 10(a)(iv), (vi), (vii) in (ix), ter vse ustrezne navedbe v členu 10(a)(viii), najprej predloži registracijski zavezanec, ki deluje na podlagi skupnega dogovora z drugim(-i) registracijskim(-i) - zavezancem(-i) (v nadaljevanju „glavni registracijski zavezanec“).
Each registrant shall subsequently submit separately the information specified in Article 10(a)(i), (ii), (iii) and (x), and any relevant indication under Article 10(a)(viii).
Vsak registracijski zavezanec kasneje ločeno predloži informacije, določene v členu 10(a)(i), (ii), (iii) in (x), ter vse ustrezne navedbe iz člena 10(a)(viii).
The registrants may decide themselves whether to submit the information specified in Article 10(a)(v) and (b) and any relevant indication under Article 10(a)(viii) separately or whether one registrant is to submit this information on behalf of the others.
Registracijski zavezanci se lahko sami odločijo, ali bodo informacije iz člena 10(a)(v) in (b) in vse ustrezne navedbe iz člena 10 (a)(viii) predložili ločeno ali pa jih bo v imenu vseh predložil en registracijski zavezanec.
Each registrant need only comply with paragraph 1 for items of information specified in Article 10(a)(iv), (vi), (vii) and (ix) that are required for the purposes of registration within his tonnage band in accordance with Article 12.
Vsak registracijski zavezanec mora izpolnjevati določila iz odstavka 1 le za informacije, določene v členu 10(a)(iv), (vi), (vii) in (ix), ki so zahtevane za registracijo znotraj njegovega količinskega razpona v skladu s členom 12.
A registrant may submit the information referred to in Article 10(a)(iv), (vi), (vii) or (ix) separately if:
Registracijski zavezanec lahko predloži informacije iz člena 10(a)(iv), (vi), (vii) ali (ix) ločeno, če:
it would be disproportionately costly for him to submit this information jointly; or
bi bilo zanj nesorazmerno drago, če bi te informacije predložil skupaj; ali
submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or
bi predložitev teh informacij skupaj vodila k razkritju informacij, za katere meni, da so poslovno občutljive in bi mu njihovo razkritje lahko povzročilo znatno poslovno škodo; ali
he disagrees with the lead registrant on the selection of this information.
z glavnim registracijskim zavezancem ne soglaša glede izbire teh informacij.
If points (a), (b) or (c) apply, the registrant shall submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment or the nature of the disagreement, as the case may be.
Če se točke (a), (b) ali (c) uporabljajo, registracijski zavezanec skupaj z dokumentacijo predloži razlago, zakaj bi bili stroški nesorazmerni, zakaj bi razkritje informacij verjetno povzročilo znatno poslovno škodo ali kakšna je narava tega nesoglasja glede na posamezni primer.
Information to be submitted depending on tonnage
Informacije, ki se predložijo v zvezi s količino