natgillin/translations-raw huggingface dataset:
A registration for a transported isolated intermediate in quantities of more than 1000 tonnes per year per manufacturer or importer shall include the information specified in Annex VII in addition to the information required under paragraph 2.
Registracijska dokumentacija za transportiran izolirani intermediat v količini, ki znaša več kot 1000 ton na leto na proizvajalca ali uvoznika, mora poleg informacij iz odstavka 2 vključevati še informacije iz Priloge VII.
For the generation of this information, Article 13 shall apply.
Za pridobitev teh informacij se uporablja člen 13.
Paragraphs 2 and 3 shall apply only to transported isolated intermediates if the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other substance(s) from that intermediate takes place on other sites under the following strictly controlled conditions:
Odstavka 2 in 3 se za transportirane izolirane intermediate uporabljata samo, če proizvajalec ali uvoznik sam potrdi ali izjavi, da je prejel potrdilo uporabnika, da sinteza druge(-ih) snovi iz tega intermediata poteka na drugih mestih pod naslednjimi strogo nadzorovanimi pogoji:
the substance is rigorously contained by technical means during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage;
snov je v svojem celotnem življenjskem ciklusu dosledno nadzorovana s tehničnimi sredstvi, vključno s proizvodnjo, očiščevanjem, čiščenjem in vzdrževanjem opreme, vzorčenjem, analiziranjem, polnjenjem in praznjenjem opreme ali posod, odstranjevanjem ali čiščenjem odpadkov in skladiščenjem;
procedural and control technologies shall be used that minimise emission and any resulting exposure;
uporaba postopkov in tehnologij nadzora, ki zmanjšajo emisijo in izpostavljenost zaradi te na najmanjšo mero;
only properly trained and authorised personnel handle the substance;
s snovjo ravna samo ustrezno usposobljeno in pooblaščeno osebje;
in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered;
pri čiščenju in vzdrževanju se uporabijo posebni procesi, kot sta prepihavanje in spiranje, preden se sistem odpre ali se vanj vstopi;
in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures;
v primeru nesreče ali če se proizvajajo odpadki, se uporabijo procesi in/ali tehnologije nadzora za zmanjšanje emisij in izpostavljenosti zaradi njih med procesi očiščevanja ali čiščenja in vzdrževanja na najmanjšo mero;
substance-handling procedures are well documented and strictly supervised by the site operator.
procesi za ravnanje s snovjo so dobro dokumentirani in pod strogim nadzorom upravljavca mesta.
If the conditions listed in the first subparagraph are not fulfilled, the registration shall include the information specified in Article 10.
Če pogoji iz prvega pododstavka niso izpolnjeni, se v registracijsko dokumentacijo vključijo informacije iz člena 10.
Joint submission of data on isolated intermediates by multiple registrants
Skupna predložitev podatkov o izoliranih intermediatih s strani več registracijskih zavezancev
When an on-site isolated intermediate or transported isolated intermediate is intended to be manufactured in the Community by one or more manufacturers and/or imported by one or more importers, the following shall apply.
Če naj bi na mestu izolirani intermediat ali transportirani intermediat v Skupnosti proizvajal eden ali več proizvajalcev in/ali uvažal eden ali več uvoznikov, se uporabi naslednje.
Subject to paragraph 2 of this Article, the information specified in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first be submitted by one manufacturer or importer acting with the agreement of the other assenting manufacturer(s) or importer(s) (hereinafter referred to as ‘the lead registrant’).
Informacije, navedene v členu 17(2)(c) in (d) in členu 18(2)(c) in (d), ob upoštevanju odstavka 2 tega člena, najprej predloži proizvajalec ali uvoznik, ki deluje na podlagi skupnega dogovora z drugim(-i) proizvajalcem(-i) ali uvoznikom(-i) (v nadaljevanju „glavni registracijski zavezanec“).
Each registrant shall subsequently submit separately the information specified in Article 17(2)(a), (b), (e) and (f) and Article 18(2)(a),(b), (e) and (f).
Vsak registracijski zavezanec kasneje ločeno predloži informacije iz člena 17(2)(a), (b), (e) in (f) ter člena 18(2)(a), (b), (e) in (f).
A manufacturer or importer may submit the information referred to in Article 17(2)(c) or (d) and Article 18(2)(c) or (d) separately if:
Proizvajalec ali uvoznik lahko predloži informacije iz člena 17(2)(c) ali (d) in člena 18(2)(c) ali (d) ločeno, če:
it would be disproportionately costly for him to submit this jointly; or
bi bilo zanj nesorazmerno drago, če bi to predložil skupaj; ali
If points (a), (b) or (c) apply, the manufacturer or importer 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, proizvajalec ali uvoznik 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.
Common provisions for all registrations
Skupne določbe za vse registracije
Duties of the Agency
Naloge Agencije
The Agency shall assign a submission number to each registration, which is to be used for all correspondence regarding the registration until the registration is deemed to be complete, and a submission date, which shall be the date of receipt of the registration at the Agency.
Agencija vsaki registraciji ob predložitvi dodeli številko, ki se mora uporabljati za vse dopise, povezane z registracijo, dokler se registracija ne šteje za zaključeno, ter datum predložitve, ki je datum, na katerega je Agencija prejela registracijo.
The Agency shall undertake a completeness check of each registration in order to ascertain that all the elements required under Articles 10 and 12 or under Articles 17 or 18, as well as the registration fee referred to in Article 6(4), Article 7(1) and (5), Article 17(2) or Article 18(2), have been provided.
Agencija preveri popolnost posameznih registracij, da preveri, ali so bili predloženi vsi sestavni deli, ki se zahtevajo v skladu s členoma 10 in 12 ali členoma 17 ali 18, ter ali je bila plačana pristojbina za registracijo iz člena 6(4), člena 7(1) in (5), člena 17(2) ali člena 18(2).
The completeness check shall not include an assessment of the quality or the adequacy of any data or justifications submitted.
Pregled popolnosti ne vključuje ocene kakovosti ali ustreznosti predloženih podatkov ali dokazil.
The Agency shall undertake the completeness check within three weeks of the submission date, or within three months of the relevant deadline of Article 23, as regards registrations of phase-in substances submitted in the course of the two-month period immediately preceding that deadline.
Kar zadeva registracijo snovi v postopnem uvajanju, predloženo dva meseca pred potekom ustreznega roka iz člena 23, Agencija preveri popolnost v treh tednih po datumu predložitve ali tri mesece po poteku tega roka.
If a registration is incomplete, the Agency shall inform the registrant, before expiry of the three-week or three-month period referred to in the second subparagraph, as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this.
Če je registracija nepopolna, Agencija pred potekom roka treh tednov ali treh mesecev iz drugega pododstavka obvesti registracijskega zavezanca o nadaljnjih informacijah, ki so potrebne za popolno registracijo, ter za to določi razumen rok.
The registrant shall complete his registration and submit it to the Agency within the deadline set.
Registracijski zavezanec svojo registracijo dopolni in jo v predpisanem roku predloži Agenciji.
The Agency shall confirm the submission date of the further information to the registrant.
Agencija registracijskemu zavezancu potrdi datum predložitve dodatnih informacij.
The Agency shall perform a further completeness check, considering the further information submitted.
Agencija opravi dodatni pregled popolnosti in pri tem upošteva predložene dodatne informacije.
The Agency shall reject the registration if the registrant fails to complete his registration within the deadline set.
Agencija registracijo zavrne, če je registracijski zavezanec ne dopolni v predpisanem roku.
The registration fee shall not be reimbursed in such cases.
Pristojbina za registracijo se v takšnih primerih ne povrne.
Once the registration is complete, the Agency shall assign a registration number to the substance concerned and a registration date, which shall be the same as the submission date.
Ko je registracija zaključena, Agencija zadevni snovi določi registracijsko številko in datum registracije, ki je enak datumu predložitve.
The Agency shall without delay communicate the registration number and registration date to the registrant concerned.
Agencija registracijsko številko in datum registracije nemudoma sporoči zadevnemu registracijskemu zavezancu.
The registration number shall be used for all subsequent correspondence regarding registration.
Registracijska številka se uporablja za vse poznejše dopise, povezane z registracijo.
The Agency shall notify the competent authority of the relevant Member State within 30 days of the submission date, that the following information is available in the Agency database:
Agencija pristojni organ zadevne države članice v roku 30 dni po datumu predložitve obvesti o tem, da so v podatkovni zbirki Agencije na voljo naslednje informacije:
the registration dossier together with the submission or registration number;
registracijska dokumentacija, skupaj s številko predložitve ali registracije;
the submission or registration date;
datum predložitve ali registracije;
the result of the completeness check; and
rezultat pregleda popolnosti; ter
any request for further information and deadline set in accordance with the third subparagraph of paragraph 2.
vse zahteve za dodatne informacije in rok, določen v skladu s tretjim pododstavkom odstavka 2.
The relevant Member State shall be the Member State within which the manufacture takes place or the importer is established.
Zadevna država članica je država članica, v kateri poteka proizvodnja ali v kateri ima uvoznik svoj sedež.
If the manufacturer has production sites in more than one Member State, the relevant Member State shall be the one in which the head office of the manufacturer is established.
Če se proizvajalčevi proizvodni obrati nahajajo v več kot eni državi članici, je zadevna država članica tista, v kateri ima proizvajalec svoj sedež.
The other Member States where the production sites are established shall also be notified.
Obveščene so tudi druge države članice, v katerih se nahajajo proizvodni obrati.
The Agency shall forthwith notify the competent authority of the relevant Member State(s) when any further information submitted by the registrant is available on the Agency database.
Agencija pristojni organ zadevne države članice obvesti takoj, ko so kakršne koli dodatne informacije, ki jih je predložil registracijski zavezanec, na voljo v podatkovni zbirki Agencije.
An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraph 2 of this Article.
Proti odločitvam Agencije iz odstavka 2 tega člena se lahko vloži pritožba v skladu s členi 91, 92 in 93.
Where additional information for a particular substance is submitted to the Agency by a new registrant, the Agency shall notify the existing registrants that this information is available on the database for the purposes of Article 22.
Če novi registracijski zavezanec Agenciji predloži dodatne informacije o določeni snovi, Agencija obstoječe registracijske zavezance obvesti, da so te informacije na voljo v podatkovni zbirki za namene člena 22.
Manufacturing and import of substances
Proizvodnja in uvoz snovi
A registrant may start or continue the manufacture or import of a substance or production or import of an article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the submission date, without prejudice to Article 27(8).
Registracijski zavezanec lahko začne snov proizvajati ali uvažati ali izdelovati ali uvažati izdelek oziroma s tem nadaljuje, če Agencija v skladu s členom 20(2) v treh tednih po datumu predložitve ne navede drugače in brez vpliva na člen 27(8).
In the case of registrations of phase-in substances, such a registrant may continue the manufacture or import of the substance or production or import of an article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the submission date or, if submitted within the two-month period before the relevant deadline of Article 23, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three months from that deadline, without prejudice to Article 27(8).
V primeru registracij snovi v postopnem uvajanju lahko tak registracijski zavezanec nadaljuje s proizvajanjem ali z uvažanjem snovi ali izdelovanjem ali uvažanjem izdelka, če Agencija v skladu s členom 20(2) v treh tednih po datumu predložitve ne navede drugače ali če je registracija predložena dva meseca pred potekom ustreznega roka iz člena 23 in Agencija v skladu s členom 20(2) v treh mesecih od roka ne navede drugače in to ne posega v člen 27(8).
In the case of an update of a registration according to Article 22 a registrant may continue the manufacture or import of the substance, or the production or import of the article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the update date, without prejudice to Article 27(8).
V primeru dopolnitve registracije v skladu s členom 22 lahko registracijski zavezanec nadaljuje s proizvajanjem ali uvažanjem snovi ali z izdelavo ali uvažanjem izdelka, če Agencija v skladu s členom 20(2) v treh tednih po datumu dopolnitve ne navede drugače in to ne posega v člen 27(8).
If the Agency has informed the registrant that he is to submit further information in accordance with the third subparagraph of Article 20(2), the registrant may start the manufacture or import of a substance or production or import of an article if there is no indication to the contrary from the Agency within the three weeks after receipt by the Agency of the further information necessary to complete his registration, without prejudice to Article 27(8).
Če je Agencija registracijskega zavezanca obvestila, da mora predložiti dodatne informacije v skladu s tretjim pododstavkom člena 20(2), lahko registracijski zavezanec, če Agencija ne navede drugače in brez poseganja v člen 27(8), proizvodnjo ali uvoz snovi ali izdelovanje ali uvoz izdelka začne tri tedne po tem, ko Agencija prejme dodatne informacije, potrebne za dopolnitev njegove registracije.
If a lead registrant submits parts of the registration on behalf of one or more other registrants, as provided for in Articles 11 or 19, any of the other registrants may manufacture or import the substance or produce or import the articles only after the expiry of the time-limit laid down in paragraph 1 or 2 of this Article and provided that there is no indication to the contrary from the Agency in respect of the registration of the lead registrant acting on behalf of the others and his own registration.
Če glavni registracijski zavezanec predloži del registracije v imenu enega ali več registracijskih zavezancev, kot predvideva člen 11 ali 19, lahko začne kateri koli drugi registracijski zavezanec proizvajati ali uvažati snov ali izdelovati ali uvažati izdelke šele po poteku roka iz odstavka 1 ali 2 tega člena in če Agencija ne navede drugače v zvezi z registracijo glavnega registracijskega zavezanca, ki deluje v imenu drugih ali njegove registracije.
Further duties of registrants
Nadaljnje obveznosti registracijskih zavezancev
Following registration, a registrant shall be responsible on his own initiative for updating his registration without undue delay with relevant new information and submitting it to the Agency in the following cases:
Po registraciji mora registracijski zavezanec na svojo pobudo in brez nepotrebnega odlašanja svojo registracijo dopolniti s pomembnimi novimi informacijami in jo predložiti Agenciji v naslednjih primerih:
any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address;
sprememba njegovega statusa, kot je proizvajalec, uvoznik ali izdelovalec izdelkov, ali sprememba njegovih podatkov, kot je ime ali naslov;
any change in the composition of the substance as given in Section 2 of Annex VI;
sprememba sestave snovi v skladu z oddelkom 2 Priloge VI;
changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import;
sprememba letnih ali skupnih količin, ki jih proizvede ali uvozi, ali količin snovi v izdelkih, ki jih izdela ali uvozi, če imajo za posledico spremembo količinskega razpona, vključno s prenehanjem proizvodnje ali uvoza;
new identified uses and new uses advised against as in Section 3.7 of Annex VI for which the substance is manufactured or imported;
nove določene uporabe in nove priporočene uporabe oddelka 3.7 Priloge VI, za katere se snov proizvaja ali uvaža;
new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report;
nova spoznanja glede tveganj snovi za zdravje ljudi in/ali okolje, za katera se lahko upravičeno pričakuje, da je z njimi seznanjen in ki vodijo k spremembam varnostnega lista ali poročila o kemijski varnosti;
any change in the classification and labelling of the substance;
vsaka sprememba v razvrstitvi in označitvi snovi;
any update or amendment of the chemical safety report or Section 5 of Annex VI;
vsaka posodobitev ali sprememba poročila o kemijski varnosti ali oddelka 5 Priloge VI;
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;
ugotovitev registracijskega zavezanca, da je treba opraviti test v skladu s Prilogo IX ali Prilogo X; v tem primeru je treba oblikovati predlog za testiranje;
any change in the access granted to information in the registration.
sprememba odobrenega dostopa do informacij v registraciji.
The Agency shall communicate this information to the competent authority of the relevant Member State.
Agencija sporoči te informacije pristojnemu organu zadevne države članice.
A registrant shall submit to the Agency an update of the registration containing the information required by the decision made in accordance with Articles 40, 41 or 46 or take into account a decision made in accordance with Articles 60 and 73, within the deadline specified in that decision.
Registracijski zavezanec Agenciji predloži dopolnitev registracije, ki vsebuje informacije, zahtevane na podlagi sklepa v skladu s členom 40, 41 ali 46, ali upošteva sklep, sprejet v skladu s členoma 60 in 73, v roku, ki je naveden v sklepu.
The Agency shall notify the competent authority of the relevant Member State that the information is available on its database.
Agencija pristojni organ ustrezne države članice obvesti, da so informacije na voljo v njeni podatkovni zbirki.
The Agency shall undertake a completeness check according to Article 20(2) first and second subparagraphs of each updated registration.
Agencija preveri popolnost posameznih dopolnjenih registracij v skladu s prvim in drugim pododstavkom člena 20(2).
In cases where the update is in accordance with Article 12(2) and with paragraph 1(c) of this Article then the Agency shall check the completeness of the information supplied by the registrant and Article 20(2) shall apply adapted as necessary.
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).
In cases covered by Articles 11 or 19, each registrant shall submit separately the information specified in paragraph 1(c) of this Article.
V primerih iz člena 11 ali 19 vsak registracijski zavezanec informacije iz odstavka 1(c) tega člena predloži ločeno.
An update shall be accompanied by the relevant part of the fee required in accordance with Title IX.
Ob dopolnitvi se plača ustrezni del pristojbine, ki se zahteva v skladu z naslovom IX.
Transitional provisions applicable to phase-in substances and notified substances
Prehodne določbe, ki se uporabljajo za snovi v postopnem uvajanju in prijavljene snovi
Specific provisions for phase-in substances
Posebne določbe za snovi v postopnem uvajanju
Article 5, Article 6, Article 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 December 2010 to the following substances:
Členi 5, 6, 7(1), 17, 18 in 21 se ne uporabljajo za naslednje snovi do 1. decembra 2010:
phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, in accordance with Directive 67/548/EEC and manufactured in the Community or imported, in quantities reaching one tonne or more per year per manufacturer or per importer, at least once after 1 June 2007;
snovi v postopnem uvajanju, ki so v skladu z Direktivo 67/548/EGS razvrščene kot rakotvorne, mutagene ali strupene za razmnoževanje v skupino 1 ali 2 in so bile vsaj enkrat po 1. juniju 2007 v Skupnosti proizvedene ali v Skupnost uvožene v količini, ki je znašala eno tono ali več na leto na proizvajalca ali uvoznika;
phase-in substances classified as very toxic to aquatic organisms which may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC, and manufactured in the Community or imported in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007;
snovi v postopnem uvajanju, ki so v skladu z Direktivo 67/548/EGS razvrščene kot zelo strupene za vodne organizme, ki lahko povzročijo dolgoročne neugodne posledice v vodnem okolju (R50/53), in so bile vsaj enkrat po 1. juniju 2007 v Skupnosti proizvedene ali v Skupnost uvožene v količini, ki je znašala 100 ton ali več na leto na proizvajalca ali uvoznika;
phase-in substances manufactured in the Community or imported, in quantities reaching 1000 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007.
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 1000 ton ali več na leto na proizvajalca ali uvoznika.
Article 5, Article 6, Article 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 June 2013 to phase-in substances manufactured in the Community or imported, in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007.
Členi 5, 6, 7(1), 17, 18 in 21 se ne uporabljajo do 1. junija 2013 za snovi v postopnem uvajanju, ki so bile vsaj enkrat po 1. juniju 2007 proizvedene v Skupnosti ali v Skupnost uvožene v količini, ki je znašala 100 ton ali več na leto na proizvajalca ali uvoznika.