natgillin/translations-raw huggingface dataset:
Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58). ) OJ L 311, 28.11.2001, p. 67.
Direktiva, kakor je bila nazadnje spremenjena z Direktivo 2004/28/ES (UL L 136, 30.4.2004, str. 58). ) UL L 311, 28.11.2001, str. 67.
Directive as last amended by Regulation (EC) No 1901/2006. ) OJ L 40, 11.2.1989, p. 27.
Direktiva, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1901/2006. ) UL L 40, 11.2.1989, str. 27.
L 136/19 exemption from these Titles does not prejudice the objectives of this Regulation;
(b) snovi iz Priloge V, glede na to, daje zanje registracija neustrezna ali nepotrebna in da izjema zanje v zvezi s temi naslovi ne posega v cilje te uredbe;
(c) substances on their own or in preparations, registered in accordance with Title II, exported from the Community by an actor in the supply chain and re-imported into the Community by the same or another actor in the same supply chain who shows that:
(c) snovi kot take ali v pripravkih, registrirane v skladu z naslovom II, ki jih udeleženec dobavne verige izvozi iz Skupnosti, nazaj v Skupnost pa jih ponovno uvozi isti ali drug udeleženec iste dobavne verige, ki dokaže:
(ii) as a flavouring in foodstuffs within the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (1) and Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council (2);
(ii) kot aromatski dodatek živilom na področju uporabe Direktive Sveta 88/388/EGS z dne 22. junija 1988 o približevanju zakonodaje držav članico aromah za uporabo v živilih in izhodnih surovinah za njihovo proizvodnjo (1) in Odločbe Komisije 1999/217/ES z dne 23. februarja 1999 o registru aromatičnih snovi, ki se uporabljajo v živilih ali na njih, pripravljenem skladno z Uredbo (ES) št. 2232/96 Evropskega parlamenta in Sveta (2);
(iii) as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (3);
(iii) kot dodatek krmi na področju uporabe Uredbe (ES) št. 1831/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o dodatkih za uporabo v prehrani živali (3);
(ii) he has been provided with the information in accordance with Articles 31 or 32 relating to the exported substance;
(ii) daje za izvoženo snov dobil informacije v skladu s členom 31 ali 32;
(iv) in animal nutrition within the scope of Council Directive 82/471/EEC of 30 June 1982 concerning certain
(iv) v prehrani živali na področju uporabe Direktive Sveta 82/471/EGS z dne 30. junija 1982 o nekaterih proizvodih, ki se uporabljajo v prehrani živali (4).
(d) substances, on their own, in preparations or in articles, which have been registered in accordance with Title II and which are recovered in the Community if:
(d) snovi kot take, v pripravkih ali izdelkih, ki so bile registrirane v skladu z naslovom II in ki so predelane v Skupnosti, če:
(i) the substance that results from the recovery process is the same as the substance that has been registered in accordance with Title II; and
(i) je snov, ki je nastala v procesu predelave, ista kot snov, ki je bila registrirana v skladu z naslovom II; in
(a) medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC;
(a) zdravila za humano in veterinarsko uporabo na področju uporabe Uredbe (ES) št. 726/2004 in Direktive 2001/82/ES ter kakor je opredeljeno v Direktivi 2001/83/ES;
(c) medical devices which are invasive or used indirect physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and preparations which ensure the same level of information provision and protection as Directive 1999/45/EC;
(c) medicinske pripomočke, ki so invazivni ali se uporabljajo v neposrednem fizičnem stiku s človeškim telesom, če ukrepi Skupnosti določajo določbe za razvrščanje in označevanje nevarnih snovi in pripravkov, ki zagotavljajo enako raven informacij in zaščite kot Direktiva 1999/45/ES;
(d) food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:
(d) hrano ali krmo skladno z Uredbo (ES) št. 178/2002, vključno z uporabo:
(i) as a food additive in foodstuffs within the scope of Directive 89/107/EEC;
(i) kot dodatek živilom na področju uporabe Direktive 89/107/EGS;
(ii) as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC;
(ii) kot aromatski dodatek živilom na področju uporabe Direktive 88/388/EGS in Odločbe 1999/217/ES;
(iii) as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003;
(iii) kot dodatek krmi na področju uporabe Uredbe (ES) št. 1831/2003; živali na področju uporabe
(b) substances covered by Annex V, as registration is deemed in appropriate or unnecessary for these substances and their
(a) snovi iz Priloge IV, glede na to, daje o njih znanih dovolj podatkov, da zanje zaradi njihovih intrinzičnih lastnosti velja minimalno tveganje;
Directive as last amended by Commission Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81).
Direktiva, kakor je bila nazadnje spremenjena z Direktivo Komisije 2004/116/ES (UL L 379, 24.12.2004,
15. intermediate: means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis): producer of an article: means any natural or legal person who makes or assembles an article within the Community;
Izdelovalec izdelka: pomeni fizično ali pravno osebo, ki izdeluje ali sestavlja izdelek v Skupnosti.
Such molecules must be distributed over a range of molecular weights where in differences in the molecular weight are primarily attributable to differences in the number of monomer units.
Takšne molekule morajo biti porazdeljene v okviru določenega razpona molekulske mase, pri čemer se razlike v molekulski masi lahko pripišejo predvsem razlikam v številu monomernih enot.
(a) non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place.
(a) neizoliran intermediat: pomeni intermediat, ki se med sintezo ne odstrani namerno (razen za vzorčenje) iz opreme, v kateri poteka sinteza.
Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;
Takšna oprema vključuje reakcijsko posodo, njeno pomožno opremo in v so opremo, skozi katero gre(-do) snov(-i) med neprekinjenim ali saržnim procesom, ter cevi za prenos iz ene posode v drugo za naslednjo reakcijsko fazo, ne vključuje pa cistern ali drugih posod, v katerih se snov(-i) hrani(-jo) po proizvodnji;
(a) a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;
(a) navadno masno večino molekul z vsaj tremi monomernimi enotami, ki so s kovalentno vezjo povezane vsaj še z eno drugo monomerno enoto ali drugim reaktantom;
(b) less than a simple weight majority of molecules of the same molecular weight.
(b) manj kot navadno masno večino molekul z enako molekulsko maso.
In the context of this definition a ‘monomer unit’ means the reacted form of a monomer substance in a polymer;
(b) na mestu izoliran intermediat: pomeni intermediat, ki ne izpolnjuje kriterijev za neizolirani intermediat, pri čemer proizvodnja intermediata in sinteza druge(-ih) snovi iz tega intermediata potekata na istem mestu, izvaja pa ju ena ali več pravnih subjektov;
(b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities;
V okviru te opredelitve pomeni „monomerna enota“ vezano obliko monomerne snovi v polimeru.
monomer: means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymerforming reaction used for the particular process;
(c) transportiran izoliran intermediat: pomeni intermediat, ki ne izpolnjuje kriterijev za neizoliran intermediat, ki se prepelje z enega mesta na drugo mesto oziroma prepelje z drugega mesta.
(c) transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites;
Monomer: pomeni snov, ki je zmožna tvoriti kovalentne vezi z zaporedjem dodatnih podobnih ali drugačnih molekul, pod pogoji ustrezne reakcije, pri kateri se tvorijo polimeri, in se uporablja za ta posebni proces.
16. site: means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared;
Registracijski zavezanec: pomeni proizvajalca ali uvoznika snovi oz. izdelovalca ali uvoznika izdelka, ki predloži registracijo snovi.
or extraction of manufacturing: means production substances in the natural state;
Proizvodnja: pomeni proizvodnjo ali ekstrakcijo snovi v naravnem stanju.
10. import: means the physical introduction into the customs territory of the Community;
Proizvajalec: pomeni fizično ali pravno osebo s stalnim bivališčem oziroma sedežem v Skupnosti, ki proizvaja snov v Skupnosti.
A re-importer exempted pursuant to Article 2 (7)(c) shall be regarded as a downstream user;
Ponovni uvoznik, izvzet v skladu s členom 2(7)(c), se šteje za nadaljnjega uporabnika.
L 136/21 factured for at least three consecutive years, quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years;
L 136/21 proizvajajo vsaj tri leta zapored, se letne količine izračunajo na podlagi povprečja obsega proizvodnje ali uvoza iz treh predhodnih koledarskih let.
(c) it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this;
(c) snov je proizvajalec ali uvoznik dal v promet v Skupnosti ali v državah, ki so k Evropski uniji pristopile 1. januarja 1995 ali 1. maja 2004, pred začetkom veljavnosti te uredbe in je veljala za prijavljeno v skladu s prvo alineo člena 8(1) Direktive 67/548/EGS, a ne ustreza opredelitvi polimera iz te uredbe, pod pogojem, da ima proizvajalec ali uvoznik o tem dokumentarna dokazila.
SME: means small and mediumsized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and mediumsized enterprises (1);
MSP: pomeni mala in srednje velika podjetja, kakor so opredeljena v Priporočilu Komisije z dne 6. maja 2003
(a) 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);
(a) 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;
(b) the total quantity of such monomer substance(s) or other substance(s) makes up one tonne or more per year.
(b) skupna količina takšne(-ih) monomerne(-ih) ali druge(-ih) snovi znaša eno tono ali več na leto.
Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users.
Proizvajalec, uvoznik ali, kjer je to ustrezno, nadaljnji uporabnik lahko ob tem, daje še naprej polno odgovoren za izpolnjevanje svojih obveznosti po tej uredbi, imenuje zastopnika tretje strani za vse postopke iz člena 11, člena 19, naslova III in člena 53, ki zadevajo razgovore z drugimi proizvajalci, uvozniki ali, kjer je to ustrezno, z ustreznimi nadaljnjimi uporabniki.
REGISTRATION OF SUBSTANCES
Registracija in prijava snovi v izdelkih
(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
(a) ti izdelki vsebujejo snov v količini, ki znaša skupaj več kot eno tono na leto na izdelovalca ali uvoznika;
Article 5
Člen 5 registracije se plača pristojbina v skladu
(b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.
Ob predložitvi z naslovom IX.
No data, no market
Brez podatkovni trga
(b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).
(b) ti izdelki vsebujejo snov v količini, ki je višja od koncentracije 0,1 % mas. m/m.
General obligation to register substances on their own or in preparations
Splošna obveznost snovi kot takih ali registriranja v pripravkih
(a) 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;
(a) podatke o izdelovalcu ali uvozniku ter podatke za vzpostavitev stika z njim, kakor je določeno v oddelku 1 Priloge VI, razen njihovih mest uporabe;
L 136/23 information on the supply of the latest update of the safety data sheet referred to in Article 31.
(c) identiteto(-e) o snovi(-eh) v skladu z oddelki 2.1 do 2.3.4 Priloge VI;
(c) the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI; as specified in
(d) razvrstitev snovi, kakor je določeno v oddelkih 4.1 in 4.2 Priloge VI;
Exemption from the general obligation to register for product and process orientated research and development (PPORD)
(a) ti izdelki vsebujejo snov v količini, ki znaša skupaj več kot eno tono na leto na izdelovalca ali uvoznika;
(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
Izvzetje iz splošne obveznosti registriranja za v proizvod in proces usmerjene raziskave in razvoj (PPORD)
(b) the Agency has grounds for suspecting that:
(b) Agencija lahko utemeljeno domneva, da:
(i) the substance is released from the articles, and
(i) se snov sprošča iz izdelkov; in
(ii) the release of the substance from the articles presents a risk to human health or the environment;
(ii) sprostitev snovi iz izdelkov predstavlja tveganje za zdravje ljudi ali za okolje;
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 letne 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.
(c) the substance is not subject to paragraph 1.
(c) za snov ne velja odstavek 1.
A submission for registration shall be accompanied by the fee required in accordance with Title IX.
registracije se plača pristojbina v skladu
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 zato uporabo že bile registrirane.
(b) the identity of the substance, as specified in section 2 of Annex VI;
(b) identiteto snovi, kakor je določeno v oddelku 2 Priloge VI;
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).
(c) the classification of the substance as specified in section 4 of Annex VI, if any;
(c) razvrstitev snovi, če obstaja, kakor je določeno v oddelku 4 Priloge VI; količino, kakor je določeno v oddelku
(d) the estimated quantity as specified in section 3.1 of Annex VI;
(e) seznam kupcev iz odstavka 1 ter njihova imena in naslove.
The period set out in paragraph 1 shall begin at receipt of the notification at the Agency.
Edini zastopnik proizvajalca, ki nima sedeža v Skupnosti
Information to be general registration submitted for purposes
(a) tehnično dokumentacijo, ki zajema:
A registration required by Article 6 or by Article 7(1) or (5) shall include all the following information:
(i) podatke o proizvajalcu(-ih) ali uvozniku(-ih), kakor je določeno v oddelku 1 Priloge VI;
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 publicat 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.
(a) a technical dossier including:
(ii) identiteto snovi, kakor je določeno v oddelku 2 Priloge VI;
(i) the identity of the manufacturer(s) or importer(s) as specified in section 1 of Annex VI;
(iii) informacije o proizvodnji in uporabi(-ah) snovi, kakor je določeno v oddelku 3 Priloge VI; te informacije vključujejo vse navedene uporabe registracijskega zavezanca.
(ii) the identity of the substance as specified in section 2 of Annex VI;
Če registracijski zavezanec meni, daje to primerno, lahko te informacije vključujejo ustrezno kategorijo uporabe in izpostavljenosti;
(iv) the classification and labelling of the substance as specified in section 4 of Annex VI;
(iv) razvrstitev in označitev snovi, kakor je določeno v oddelku 4 Priloge VI;
(v) guidance on safe use of the substance as specified in Section 5 of Annex VI;
(v) navodila za varno uporabo snovi, kakor je določeno v oddelku 5 Priloge VI;
(vi) study summaries of the information derived from the application of Annexes VII to XI;
(vi) povzetke študij za informacije, ki izhajajo iz uporabe prilog VII do XI;
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, dana 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, daje takšno podaljšanje upravičeno.
(vii) robust study summaries of the information derived from the application of Annexes VII to XI, if required under Annex I;
(vii) grobe povzetke študij za informacije, ki izhajajo iz uporabe prilog VII do XI, če se zahtevajo v skladu s Prilogo I;
(x) for substances in quantities of 1 to 10 tonnes, exposure information as specified in section 6 of Annex VI;
(viii) 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;
(xi) a request as to which of the information in Article 1 19(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.
(ix) predloge za testiranje, kjer je to navedeno v prilogah IX in X;
L 136/25 lead to substantial commercial detriment or the nature of the disagreement, as the case may be.
L 136/25 nesorazmerni, zakaj bi razkritje informacij verjetno povzročilo znatno poslovno škodo ali kakšna je narava tega nesoglasja glede na posamezni primer.
(b) 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.
(b) 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, daje to primerno, kategorijo uporabe in izpostavljenosti.
The technical dossier referred to in Article 10(a) shall include under points (vi) and (vii) of that provisional l physicochemical, toxicological and ecotoxicological information that is relevant and available to the registrant and as a minimum the following:
Tehnična dokumentacija iz člena 10(a) mora v zvezi s točkama (vi) in (vii) navedene določbe vključevati vse pomembne in za registracijskega zavezanca razpoložljive fizikalnokemijske, toksikološke in ekotoksikološke podatke ter vsaj:
(a) the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the criteria specified in Annex III, manufactured or imported in quantities of one tonne or more per year per manufacturer or importer;
(a) informacije iz Priloge VII za snovi, ki niso v postopnem uvajanju, ter za snovi v postopnem uvajanju, ki izpolnjujejo enega ali več kriterijev iz Priloge III in se proizvedejo ali uvozijo v količini, ki znaša eno tono ali več na leto na proizvajalca ali uvoznika;
(b) the information on physicochemical properties specified in Annex VII, section 7 for phase-in substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex III;
(b) informacije o fizikalno-kemijskih lastnostih iz oddelka 7 Priloge VII za snovi v postopnem uvajanju, ki se proizvedejo ali uvozijo v količini, ki znaša eno tono ali več na leto na proizvajalca ali uvoznika in ne izpolnjujejo nobenega izmed kriterijev iz Priloge III;
(c) the information specified in Annexes VII and VIII for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer;
(c) informacije iz prilog VII in VIII za snovi, ki se proizvedejo ali uvozijo v količini, ki znaša 10 ton ali več na leto na proizvajalca ali uvoznika;