natgillin/translations-raw huggingface dataset:
(h) the registrant identifies the need to perform a test listed in Annex IX or Annex X, in which cases a testing proposal shall be developed;
(h) ugotovitev registracijskega zavezanca, daje treba opraviti test v skladu s Prilogo IX ali Prilogo X; v tem primeru je treba oblikovati predlog za testiranje;
(c) phase-in substances manufactured in the Community or imported, in quantities reaching 1 000 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007.
(i) sprememba odobrenega dostopa do informacij v registraciji.
(i) any change in the access granted to information in the registration.
(c) snovi v postopnem uvajanju, ki so bile vsaj enkrat po 1. juniju 2007 v Skupnosti proizvedene ali v Skupnost uvožene v količini, ki je znašala 1 000 ton ali več na leto na proizvajalca ali uvoznika.
The Agency shall undertake a completeness check according to Article 20(2) first and second subparagraphs of each updated registration.
V primerih, ko je dopolnitev v skladu s členom 12(2) in odstavkom 1(c) tega člena, Agencija preveri popolnost informacij, ki jih je predložil registracijski zavezanec, in po potrebi se uporabi prilagojeni člen 20(2).
Notified substances registered in accordance with Article 28, shall inquire from the Agency whether a registration has already been submitted for the same substance.
Prijavljene snovi snov v postopnem uvajanju, ki se ni predhodno registriral v skladu s členom 28, poizve pri Agenciji, ali je bila za enako snov že vložena registracija.
(a) his identity as specified in Section 1 of Annex VI, with the exception of the use sites;
(a) svoje podatke, kakor je določeno v oddelku 1 Priloge VI, razen mest uporabe;
(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;
(c) which information requirements would require new studies involving vertebrate animals to be carried out by him;
(c) za katere zahtevane informacije bo moral izvesti nove študije, ki bodo vključevale vretenčarje;
(d) which information requirements would require other new studies to be carried out by him.
(d) za katere zahtevane informacije bo moral izvesti druge nove študije.
In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort.
Da se preprečijo testiranja na živalih, se testiranje na vretenčarjih zato uredbo opravijo samo v skrajni sili.
Registrants shall refrain from exchanging information concerning their market behaviour, in particular as regards production capacities, production or sales volumes, import volumes or market shares.
Registracijski zavezanci se vzdržijo izmenjave informacijo njihovem tržnem ravnanju, zlasti kar zadeva proizvodne zmogljivosti, obseg proizvodnje ali obseg prodaje, uvozne količine ali tržne deleže.
(a) shall, in the case of information involving tests on vertebrate animals; and
(a) zahteva v primeru informacij, ki vključujejo teste na vretenčarjih; in
(b) may, in the case of information not involving tests on vertebrate animals,
(b) lahko zahteva v primeru informacij, ki ne vključujejo teste na vretenčarjih,
Every potential registrant of a non-phase-in substance, or potential registrant of a phase-in substance who has not pre- request from the previous registrant(s) the information he requires with respect to Article 10(a)(vi) and (vii) in order to register.
Vsak potencialni registracijski zavezanec za snov, ki ni v postopnem uvajanju, ali potencialni registracijski zavezanec za od predhodnega(-ih) registracijskega(-ih) zavezanca(-ev) informacije, ki jih v skladu s členom 10(a)(vi) in (vii) potrebuje za registracijo.
Article 28
Pravila za snovi v postopnem uvajanju
The previous registrant and potential registrant(s) shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and nondiscriminatory way.
Predhodni registracijski zavezanec in potencialni registracijski zavezanec(-ci) storita(-jo) vse za zagotovitev, da se stroški souporabe informacij določijo na pošten, pregleden in nediskriminacijski način.
(b) his name and address and the name of the contact person and, where appropriate, the name and address of the person representing him in accordance with Article 4 as specified in Section 1 of Annex VI;
(b) svoje ime in naslov ter ime osebe za stike in po potrebi ime in naslov osebe, ki ga zastopa v skladu s členom 4, kakor je določeno v oddelku 1 Priloge VI;
If there is failure to reach such an agreement, the potential registrant(s) shall inform the Agency and the previous registrant(s) thereof at the earliest one month after receipt, from the Agency, of the name and address of the previous registrant(s).
Če se takšen sporazum ne doseže, potencialni registracijski zavezanec(-ci) o tem obvesti(-jo) Agencijo in predhodnega registracijskega zavezanca oziroma predhodne registracijske zavezance ne prej kot en mesec potem, ko od Agencije prejme(jo) ime in naslov predhodnega(-ih) registracijskega(-ih) zavezanca(-ev).
(d) the name(s) of substance(s) as specified in Section 2 of Annex VI, including their EINECS and CAS number or, if not available, any other identity codes, for which the available information is relevant for the application of Sections 1.3 and 1.5 of Annex XI.
(d) ime(-na) snovi, kakor je določeno v oddelku 2 Priloge VI, vključno z njeno številko (z njihovimi številkami) EINECS in CAS, ali če nista (niso) na voljo, s katerimi koli drugimi oznakami, za katere so razpoložljive informacije pomembne za uporabo oddelkov 1.3 in 1.5 Priloge XI.
29.5.2007 communicating within his SIEF.
29.5.2007 je na voljo ustrezna študija.
Potential registrants who manufacture or import for the first time a phase-in substance in quantities of one tonne or more per year or use for the first time a phase-in substance in the context of production of articles or import for the first time an article containing a phase-in substance that would require registration, after 1 December 2008, shall be entitled to rely on Article 23 provided that they submit the information referred to in paragraph 1 of this Article to the Agency within six months of first manufacturing, importing or using the substance in quantities of one tonne or more per year and no later than 12 months before the relevant deadline in Article 23.
Možni registracijski zavezanci, ki prvič proizvedejo ali uvozijo snov v postopnem uvajanju v količini, ki presega 1 tono ali več na leto, ali prvič uporabijo snov v postopnem uvajanju pri izdelovanju izdelkov ali prvič uvozijo izdelek, ki vsebuje snov v postopnem uvajanju, ki bijo bilo treba registrirati, po 1. decembru 2008, so upravičeni, da se sklicujejo na člen 23, pod pogojem, da Agenciji predložijo informacije iz odstavka 1 tega člena v 6 mesecih po prvem proizvajanju, uvozu ali uporabi snovi v količini, ki presega 1 tono ali več na leto, in najpozneje 12 mesecev pred ustreznim rokom iz člena 23.
The participant(s) and the owner shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and nondiscriminatory way.
Udeleženec(-ci) in lastnik storijo vse za zagotovitev, da se stroški souporabe informacij določijo na pošten, pregleden in nediskriminatoren način.
Substance Information Exchange Forums
Pristojna mesta za izmenjavo informacijo snoveh
All potential registrants, downstream users and third parties who have submitted information to the Agency in accordance with Article 28, or whose information is held by the Agency in accordance with Article 15, for the same phase-in substance, or registrants who have submitted a registration for that phase-in substance before the deadline set out in Article 23 (3), shall be participants in a substance information exchange forum (SIEF).
Vsi potencialni registracijski zavezanci, nadaljnji uporabniki in tretje strani, ki so Agenciji v skladu s členom 28 predložili informacije ali katerih informacije hrani Agencija v skladu s členom 15 za enako snov v postopnem uvajanju, ali registracijski zavezanci, ki so registracijo zato snov v postopnem uvajanju vložili pred rokom iz člena 23(3), so udeleženci foruma za izmenjavo informacijo snoveh (SIEF).
They shall take all reasonable steps to reach an agreement within a deadline set by the Agency as to who is to carry out the test on behalf of the other participants and to submit a summary or robust study summary to the Agency.
Sprejmejo vse razumne ukrepe, da se v roku, ki ga je določila Agencija, dogovorijo o tem, k dobo opravil test v imenu drugih udeležencev, in povzetek ali grob povzetek študije predložijo Agenciji.
(a) facilitate, for the purposes of registration, the exchange of the information specified in Article 10(a)(vi) and (vii) between potential registrants, thereby avoiding the duplication of studies; and
(a) za namene registracije omogočiti izmenjavo informacij, določenih v členu 10(a)(vi) in (vii) med potencialnimi registracijskimi zavezanci, in se pri tem izogniti podvajanju študij; in
(b) agree classification and labelling where there is a difference in the classification and labelling of the substance between potential registrants.
(b) dogovoriti se o razvrstitvi in označitvi, kjer med potencialnimi registracijskimi zavezanci obstaja razlika v razvrstitvi in označitvi snovi.
Before testing is carried out in order to meet the information requirements for the purposes of registration, a SIEF participant shall inquire whether a relevant study is available by
Preden se opravi test za pridobitev informacij, zahtevanih za registracijo, udeleženec SIEF v okviru svojega SIEF preveri, ali
If the owner of a study as referred to in paragraph 1 which involves testing on vertebrate animals refuses to provide either proof of the cost of that study or the study itself to (an)other participant(s), he shall not be able to proceed with registration until he provides the information to the other participants(s).
Če lastnik študije iz odstavka 1, ki vključuje testiranje na vretenčarjih, odkloni, da bo drugemu(-im) udeležencu(-em) zagotovil dokazilo o stroških te študije ali samo študijo, ne more nadaljevati z registracijo, dokler informacij ne zagotovi drugemu(-im) udeležencu(-em).
The other participant(s) shall proceed with registration without fulfilling the relevant information requirement, explaining the reason for this in the registration dossier.
Drugi udeleženec(-ci) nadaljuje(-jo) z registracijo brez izpolnitve ustreznih zahtevanih informacij in razlog zato navedejo v registracijski dokumentaciji.
However, if a registration containing this information has already been submitted by another registrant, the Agency shall give the other participant(s) permission to refer to the information in his registration dossier (s).
Vendar če je drugi registracijski zavezanec že predložil registracijo s temi informacijami, Agencija drugemu(-im) udeležencu(-em) dovoli, da se nanje sklicuje(-jo) v svoji (h) registracijski(-h) dokumentaciji(-ah).
The other registrant shall have a claim on the other participant(s) for an equal share of the cost, provided he makes the full study report available to the other participant(s), which shall be enforceable in the national courts.
Drugi registracijski zavezanec ima do drugih udeležencev terjatev enakega deleža stroškov, ki je izterljiva na nacionalnih sodiščih, pod pogojem, da drugemu(-im) udeležencu(-em) dana razpolago celovito poročilo o študiji.
L 136/35 persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or
L 136/35 zaradi drugih razlogov kot tistih iz točke (a) vključena na seznam, sestavljen v skladu s členom 59(1); ali izpostavljenosti na
(c) a substance for which there are Community workplace exposure limits.
(c) snov, za katero obstajajo omejitve delovnem mestu naravni Skupnosti.
The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or preparation is placed on the market, unless the Member State(s) concerned provide otherwise.
Varnostni list se dostavi v uradnem jeziku držav(-e) članic (-e), v katerih (kateri) se snov ali pripravek daje v promet, razen če zadevna država članica določi drugače.
hazards identification;
Zahteve za varnostne liste
10. stability and reactivity;
(c) kadar je snov zaradi drugih razlogov kot tistih iz točk (a) in (b) vključena na seznam, sestavljen v skladu s členom 59(1).
11. toxicological information;
11. toksikološke informacije;
12. ecological information;
12. ekološke informacije;
13. disposal considerations;
13. smernice odstranjevanja;
If the safety data sheet is developed for a preparation and the actor in the supply chain has prepared a chemical safety assessment for that preparation, it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the preparation instead of with the chemical safety report for each substance in the preparation.
Če se varnostni list sestavi za pripravek in je udeleženec dobavne verige pripravil oceno kemijske varnosti za pripravek, zadostuje, da so informacije iz varnostnega lista skladne s poročilom o kemijski varnosti za pripravek, in ni treba, da so skladne s poročilom o kemijski varnosti za vsako snovi z pripravka.
The supplier shall provide the recipient a this request with a safety data sheet compiled in accordance with Annex II, where a preparation does not meet the criteria for classification as dangerous in accordance with Articles 5, 6 and 7 of Directive 1999/45/EC, but contains:
Dobavitelj na zahtevo prejemnika temu priskrbi varnostni list, izpolnjen v skladu s Prilogo II, kadar pripravek ne izpolnjuje kriterijev za razvrstitev kot nevaren v skladu s členi 5, 6 in 7 Direktive 1999/45/ES, toda vsebuje:
(a) in an individual concentration of ≥ 1 % by weight for nongaseous preparations and ≥ 0,2 % by volume for gaseous preparations at least one substance posing human health or environmental hazards; or
(a) v posamezni koncentraciji ≥ 1 mas. % za neplinaste pripravke in ≥ 0,2 vol. % za plinaste pripravke vsaj eno snov, ki je nevarna za zdravje ljudi ali okolje; ali
(b) in an individual concentration of ≥ 0,1 % by weight for nongaseous preparations at least one substance that is
(b) v posamezni koncentraciji ≥ 1 mas. % za neplinaste pripravke vsaj eno snov, ki je obstojna, strupena in se lahko kopiči v organizmih ali pa je zelo obstojna in se zelo lahko kopiči v organizmih v skladu s kriteriji iz Priloge XIII ali je
(a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available;
(a) takoj ko so na voljo nove informacije, ki lahko vplivajo na ukrepe za obvladovanje tveganja, ali nove informacije o nevarnostih;
(c) once a restriction has been imposed.
(c) po uvedbi omejitve.
(b) once an authorisation has been granted or refused;
(b) po izdaji avtorizacije ali njene zavrnitve;
Duty to communicate information on substances in articles
Obvezno sporočanje informacijo snoveh v izdelkih
(b) if the substance is subject to authorisation and details of any authorisation granted or denied under Title VII in this supply chain;
(a) številko(-e) registracije (registracij) iz člena 20(3), če je (so) na voljo, za katero koli snov v skladu s točkami (b), (c) ali (d) tega odstavka;
(c) details of any restriction imposed under Title VIII;
(b) če je treba za snov pridobiti avtorizacijo ter vse podrobnosti o avtorizacijah, ki so bile v tej dobavni verigi dodeljene ali zavrnjene v skladu z naslovom VII;
Duty to communicate information on substances and preparations up the supply chain
Obvezno sporočanje informacijo snoveh in pripravkih po dobavni verigi navzgor
(d) any other available and relevant information about the substance that is necessary to enable appropriate risk management measures to be identified and applied including specific conditions resulting from the application of Section 3 of Annex XI.
(c) podrobne podatke o vseh omejitvah, uvedenih v skladu z naslovom VIII;
(a) new information on hazardous properties, regardless of the uses concerned;
(a) nove informacije o nevarnih lastnostih, ne glede na zadevne uporabe;
(b) any other information that might call into question the appropriateness of the risk management measures identified in a safety data sheet supplied to him, which shall be communicated only for identified uses.
(b) vse druge informacije, ki bi lahko povzročile dvom o ustreznosti ukrepov za obvladovanje tveganja iz dostavljenega varnostnega lista in ki bodo sporočene samo za opredeljene uporabe.
with a substance on its own or in a preparation with the aim of making this an identified use.
v pripravku, zato da bi ta postala navedena uporaba.
For registered substances, the manufacturer, importer or downstream user shall comply with the obligations laid down in Article 14 either before he next supplies the substance on its own or in a preparation to the downstream user making the request referred to in paragraph 2 of this Article, provided that the request was made at least one month before the supply, or within one month after the request, whichever is the later.
Pri registriranih snoveh mora proizvajalec, uvoznik ali nadaljnji uporabnik izpolniti obveznosti z člena 14, preden naslednjič dobavi snov kot tako ali v pripravku nadaljnjemu uporabniku, ki ga je obvestilo uporabi iz odstavka 2 tega člena, če je bilo obvestilo poslano vsaj en mesec pred dobavo ali pa v enem mesecu po obvestilu, kar nastopi pozneje.
Each manufacturer, importer, downstream user and distributor shall assemble and keep available all the information he requires to carry out his duties under this Regulation for a period of at least 10 years after he last manufactured, imported, supplied or used the substance or preparation.
Vsak proizvajalec, uvoznik, nadaljnji uporabnik in distributer zbira vse informacije, ki jih potrebuje za izvajanje svojih nalog iz te uredbe, ter jih hrani najmanj deset let potem, ko je zadnjič proizvedel, uvozil, dobavil ali uporabil snov kot tako ali v pripravku.
That manufacturer, importer, downstream user or distributor shall submit this information or make it available without delay upon request to any competent authority of the Member State in which he is established or to the Agency, without prejudice to Titles II and VI.
Ta proizvajalec, uvoznik, nadaljnji uporabnik ali distributer brez vpliva na naslova II in VI te informacije na zahtevo takoj predloži ali jih dana razpolago pristojnemu organu države članice, v kateri ima svoj sedež, ali Agenciji.
A downstream user of a substance on its own or in a preparation shall prepare a chemical safety report in accordance with Annex XII for any use outside the conditions described in an exposure scenario or if appropriate a use and exposure category communicated to him in a safety data sheet or for any use his supplier advises against.
Nadaljnji uporabnik, ki uporablja snov kot tako ali v pripravku, pripravi poročilo o kemijski varnosti v skladu s Prilogo XII za vse uporabe, ki ne spadajo pod pogoje iz predvidenega scenarija izpostavljenosti ali, kjer je to ustrezno, iz kategorije uporabe in izpostavljenosti, ki somu bili sporočeni v varnostnem listu, ali za katero koli uporabo, ki mu jo njegov dobavitelj odsvetuje.
(a) a safety data sheet is not required to be communicated with the substance or preparation in accordance with Article 31;
(a) za snov ali pripravek ni treba dostaviti varnostnega lista v skladu s členom 31;
Any downstream user shall have the right to make a use, as a minimum the brief general description of use, known in writing (on paper or electronically) to the manufacturer, importer, downstream user or distributor who supplies him
Nadaljnji uporabnik ima pravico, da o uporabi, tj. vsaj s kratkim splošnim opisom uporabe, pisno (na papirju ali v elektronski obliki) obvesti proizvajalca, uvoznika, nadaljnjega uporabnika ali distributerja, ki mu dobavlja snov kot tako ali
(b) a chemical safety report is not required to be completed by his supplier in accordance with Article 14;
(b) dobavitelju ni treba dopolniti poročila o kemijski varnosti v skladu s členom 14;
(c) the downstream user uses the substance or preparation in a total quantity of less than one tonne per year;
(c) nadaljnji uporabnik snov ali pripravek uporablja v skupni količini manj kot 1 tono na leto;
(a) the downstream user has to prepare a chemical safety report in accordance with Article 37(4); or
(a) nadaljnji uporabnik mora v skladu s členom 37(4) pripraviti poročilo o kemijski varnosti; ali
(b) the downstream user is relying on the exemptions in Article 37(4)(c) or (f).
(b) nadaljnji uporabnik se sklicuje na izvzetja iz člena 37(4)(c) ali (f).
(d) the downstream user implements or recommends an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to him in the safety data sheet;
(d) nadaljnji uporabnik izvaja ali priporoča predvideni scenarij izpostavljenosti, ki vključuje najmanj pogoje iz predvidenega scenarija izpostavljenosti, ki mu je bil sporočen v varnostnem listu;
(e) the substance is present in a preparation in a concentration lower than any of the concentrations set out in Article 14 (2);
(a) svoje podatke in podatke za stike v skladu z oddelkom 1.1 Priloge VI;
(b) the registration number(s) referred to in Article 20(3), if available;
(b) številko(-e) registracije (registracij) iz člena 20(3), če je (so) na voljo;
(c) the identity of the substance(s) as specified in Section 2.1 to 2.3.4 of Annex VI;
(f) nadaljnji uporabnik snov uporablja za v proizvod in v proces usmerjene raziskave in razvoj, pod pogojem, da so možna tveganja za zdravje ljudi in okolje pod ustreznim nadzorom v skladu z zakonskimi zahtevami v zvezi z varstvom delavcev in okolja.
(d) the identity of the manufacturer(s) or the importer(s) or other supplier as specified in Section 1.1 of Annex VI;
(d) podatke o proizvajalcu(-ih) ali uvozniku(-ih) ali drugih dobaviteljih v skladu z oddelkom 1.1 Priloge VI;
(f) except where the downstream user is relying on the exemption in Article 37(4)(c), a proposal for additional testing on vertebrate animals, where this is considered necessary by the downstream user to complete his chemical safety assessment.
(f) razen če nadaljnji uporabnik uporabi izjemo iz člena 37(4)(c) predlog dodatnih testiranj na vretenčarjih, če nadaljnji uporabnik meni, da so nujno potrebni za dokončanje njegove ocene kemijske varnosti.
(c) any information on risk management measures supplied to him in accordance with Article 32.
(c) vseh informacijah o ukrepih za obvladovanje tveganja, ki somu bile dostavljene v skladu s členom 32.
Except where a downstream user is relying on the exemption in Article 37(4)(c), reporting in accordance with paragraphs 1 to 4 of this Article shall not be required in respect of a substance, on its own or in a preparation, used by the downstream user in quantities of less than one tonne per year for that particular use.
Razen če nadaljnji uporabnik uporabi izjemo iz člena 37(4)(c), poročanje v skladu z odstavki 1 do 4 tega člena se ne zahteva za snov kot tako ali v pripravku, ki jo nadaljnji uporabnik uporablja v količini, ki ne doseže ene tone na leto zato določeno uporabo.
Before commencing or continuing with a particular use of a substance that has been registered by an actor up the supply chain in accordance with Articles 6 or 18, the downstream user shall report to the Agency the information specified in paragraph 2 of this Article, in the following cases:
Nadaljnji uporabniki morajo izpolniti zahteve iz člena 38 najpozneje v šestih mesecih po prejemu številke registracije, ki jo sporočijo njihovi dobavitelji v varnostnem listu.
Downstream users shall be required to comply with the requirements of Article 38 at the latest six months after receiving a registration number communicated to them by their suppliers in a safety data sheet.
Pred začetkom določene uporabe ali pred nadaljevanjem z določeno uporabo snovi, ki jo je registriral udeleženec dobavne verige na višji stopnji v skladu s členom 6 ali 18, nadaljnji uporabnik sporoča Agenciji informacije iz odstavka 2 tega člena v naslednjih primerih: