natgillin/translations-raw huggingface dataset:
If a relevant study involving tests is not available within the SIEF, only one study shall be conducted per information requirement within each SIEF by one of its participants acting on behalf of the others.
Če zadevna študija, ki vključuje teste, v okviru SIEF ni na voljo, eden od njegovih udeležencev v imenu ostalih v okviru posameznega SIEF izvede eno samo študijo na zahtevano informacijo.
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, kdo bo opravil test v imenu drugih udeležencev, in povzetek ali grob povzetek študije predložijo Agenciji.
If no agreement is reached, the Agency shall specify which registrant or downstream user shall perform the test.
Če dogovor ni dosežen, Agencija določi registracijskega zavezanca ali nadaljnjega uporabnika, ki opravi test.
All participants of the SIEF who require a study shall contribute to the costs for the elaboration of the study with a share corresponding to the number of participating potential registrants.
K stroškom izvajanja študije prispevajo vsi udeleženci SIEF, ki zahtevajo študijo, njihov delež pa je sorazmeren s številom udeleženih potencialnih registracijskih zavezancev.
Those participants that do not carry out the study themselves shall have the right to receive the full study report within two weeks following payment to the participant that carried out the study.
Udeleženci, ki študije ne izvajajo, imajo pravico prejeti celovito poročilo o študiji v dveh tednih po plačilu udeležencu, ki je izvedel študijo.
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 za to navedejo v registracijski dokumentaciji.
The study shall not be repeated unless within 12 months of the date of registration of the other participant(s), the owner of this information has not provided it to them and the Agency decides that the test should be repeated by them.
Študija se ne sme ponoviti, razen če 12 mesecev po datumu registracije drugih udeležencev lastnik te informacije še vedno ni delil z njimi in Agencija zato odloči, da drugi udeleženci test ponovijo.
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) da na razpolago celovito poročilo o študiji.
If the owner of a study as referred to in paragraph 1 which does not involve testing on vertebrate animals refuses to provide either proof of the cost of that study or the study itself to (an)other participant(s), the other SIEF participants shall proceed with registration as if no relevant study was available in the SIEF.
Če lastnik študije iz odstavka 1, ki ne vključuje testiranja na vretenčarjih, odkloni, da bo drugemu(-im) udeležencu(-em) zagotovil dokazilo o stroških te študije ali samo študijo, drugi udeleženci SIEF nadaljuje(-jo) z registracijo, kot če v okviru SIEF ne bi bilo na voljo ustrezne študije.
An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraphs 2 or 3 of this Article.
Proti odločitvam Agencije iz odstavka 2 ali 3 tega člena se lahko vloži pritožba v skladu s členi 91, 92 in 93.
The owner of the study who has refused to provide either proof of the cost or the study itself, as referred to in paragraph 3 or 4 of this Article, shall be penalised in accordance with Article 126.
Lastnik študije, ki zavrne zagotovitev dokazila o stroških ali same študije, kot je navedeno v odstavku 3 ali 4 tega člena, je kaznovan v skladu s členom 126.
INFORMATION IN THE SUPPLY CHAIN
OBVEŠČANJE V DOBAVNI VERIGI
Requirements for safety data sheets
Zahteve za varnostne liste
The supplier of a substance or a preparation shall provide the recipient of the substance or preparation with a safety data sheet compiled in accordance with Annex II:
Dobavitelj snovi ali pripravka dostavi prejemniku snovi ali pripravka varnostni list, izpolnjen v skladu s Prilogo II:
where a substance or preparation meets the criteria for classification as dangerous in accordance with Directives 67/548/EEC or 1999/45/EC; or
kadar snov ali pripravek izpolnjuje kriterije za razvrstitev kot nevaren v skladu z direktivama 67/548/EGS ali 1999/45/ES; ali
where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII; or
kadar je snov obstojna, se kopiči v organizmih in je strupena ali zelo obstojna in se zelo lahko kopiči v organizmih v skladu s kriteriji iz Priloge XIII; ali
where a substance is included in the list established in accordance with Article 59(1) for reasons other than those referred to in points (a) and (b).
kadar je snov zaradi drugih razlogov kot tistih iz točk (a) in (b) vključena na seznam, sestavljen v skladu s členom 59(1).
Any actor in the supply chain who is required, under Articles 14 or 37, to carry out a chemical safety assessment for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment.
Vsak udeleženec dobavne verige, ki mora v skladu s členom 14 ali 37 oceniti kemijsko varnost snovi, zagotovi, da so informacije v varnostnem listu skladne z informacijami iz te ocene.
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 snov iz pripravka.
The supplier shall provide the recipient at his 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:
in an individual concentration of ≥ 1 % by weight for non-gaseous preparations and ≥ 0,2 % by volume for gaseous preparations at least one substance posing human health or environmental hazards; or
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
in an individual concentration of ≥ 0,1 % by weight for non-gaseous preparations at least one substance that is 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
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 zaradi drugih razlogov kot tistih iz točke (a) vključena na seznam, sestavljen v skladu s členom 59(1); ali
a substance for which there are Community workplace exposure limits.
snov, za katero obstajajo omejitve izpostavljenosti na delovnem mestu na ravni Skupnosti.
The safety data sheet need not be supplied where dangerous substances or preparations offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor.
Varnostnih listov ni treba dostaviti, če so nevarne snovi ali pripravki, ki so v ponudbi ali prodaji za javnost, opremljeni z zadostnimi informacijami, ki uporabnikom omogočajo sprejetje vseh potrebnih ukrepov glede varovanja zdravja ljudi, varnosti in okolja, razen če jih ne zahteva nadaljnji uporabnik ali distributer.
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.
The safety data sheet shall be dated and shall contain the following headings:
Varnostni list se opremi z datumom in vsebuje naslednje postavke:
identification of the substance/preparation and of the company/undertaking;
identifikacija snovi/pripravka in družbe/podjetja;
hazards identification;
ugotovitve o nevarnih lastnostih;
composition/information on ingredients;
sestava/informacije o sestavinah;
first-aid measures;
ukrepi prve pomoči;
fire-fighting measures;
ukrepi ob požaru;
accidental release measures;
ukrepi ob nezgodnih izpustih;
handling and storage;
ravnanje in skladiščenje;
exposure controls/personal protection;
nadzor nad izpostavljenostjo/osebna zaščita;
physical and chemical properties;
fizikalne in kemijske lastnosti;
stability and reactivity;
obstojnost in reaktivnost;
ecological information;
ekološke informacije;
disposal considerations;
smernice odstranjevanja;
transport information;
transportne informacije;
regulatory information;
zakonsko predpisane informacije;
other information.
druge informacije.
Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 or 37 shall place the relevant exposure scenarios (including use and exposure categories where appropriate) in an annex to the safety data sheet covering identified uses and including specific conditions resulting from the application of Section 3 of Annex XI.
Vsak udeleženec dobavne verige, ki mora pripraviti poročilo o kemijski varnosti v skladu s členom 14 ali 37, doda ustrezni predvideni scenarij izpostavljenosti (vključno s kategorijo uporabe in izpostavljenosti, kjer je to potrebno) kot prilogo k varnostnemu listu, ki zajema opredeljene uporabe in vključuje posebne pogoje, ki izhajajo iz uporabe oddelka 3 Priloge XI.
Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses.
Nadaljnji uporabnik vključi ustrezne scenarije izpostavljenosti in uporabi druge ustrezne informacije iz varnostnega lista, ki mu je bil dostavljen med izdelavo njegovega lastnega varnostnega lista za opredeljene uporabe.
Any distributor shall pass on relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for uses for which he has passed on information according to Article 37(2).
Distributer posreduje ustrezne scenarije izpostavljenosti in uporabi druge ustrezne informacije iz varnostnega lista, ki mu je bil dostavljen med izdelavo njegovega lastnega varnostnega lista za uporabe, za katere je posredoval informacije v skladu s členom 37(2).
A safety data sheet shall be provided free of charge on paper or electronically.
Varnostni list se zagotovi brezplačno na papirju ali v elektronski obliki.
Suppliers shall update the safety data sheet without delay on the following occasions:
Dobavitelji takoj posodobijo varnostni list v naslednjih primerih:
as soon as new information which may affect the risk management measures, or new information on hazards becomes available;
takoj ko so na voljo nove informacije, ki lahko vplivajo na ukrepe za obvladovanje tveganja, ali nove informacije o nevarnostih;
once an authorisation has been granted or refused;
po dodelitvi avtorizacije ali njeni zavrnitvi;
once a restriction has been imposed.
po uvedbi omejitve.
The new, dated version of the information, identified as ‘Revision: (date)’, shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or preparation within the preceding 12 months.
Nova, z datumom opremljena različica varnostnega lista z oznako „Sprememba: (dne)“ se zagotovi brezplačno na papirju ali v elektronski obliki vsem predhodnim prejemnikom, ki so jim dobavili snov ali pripravek v preteklih 12 mesecih.
Any updates following registration shall include the registration number.
Posodobitve po registraciji vključujejo registracijsko številko.
Duty to communicate information down the supply chain for substances on their own or in preparations for which a safety data sheet is not required
Obvezno sporočanje informacij po dobavni verigi navzdol za snovi kot take ali v pripravkih, za katere se ne zahteva varnostnega lista
Any supplier of a substance on its own or in a preparation who does not have to supply a safety data sheet in accordance with Article 31 shall provide the recipient with the following information:
Dobavitelj snovi kot take ali v pripravku, ki mu ni treba dostaviti varnostnega lista v skladu s členom 31, prejemniku zagotovi naslednje informacije:
the registration number(s) referred to in Article 20(3), if available, for any substances for which information is communicated under points (b), (c) or (d) of this paragraph;
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;
if the substance is subject to authorisation and details of any authorisation granted or denied under Title VII in this supply chain;
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;
details of any restriction imposed under Title VIII;
podrobne podatke o vseh omejitvah, uvedenih v skladu z naslovom VIII;
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.
vse druge razpoložljive in pomembne informacije o snovi, potrebne za določitev in uporabo ustreznih ukrepov za obvladovanje tveganja, vključno s posebnimi pogoji, ki izhajajo iz uporabe oddelka 3 Priloge XI.
The information referred to in paragraph 1 shall be communicated free of charge on paper or electronically at the latest at the time of the first delivery of a substance on its own or in a preparation after 1 June 2007.
Informacije iz odstavka 1 se sporoči brezplačno na papirju ali v elektronski obliki najpozneje do prve dostave snovi kot take ali v pripravku po 1. juniju 2007.
Suppliers shall update this information without delay on the following occasions:
Dobavitelji te informacije takoj posodobijo v naslednjih primerih:
In addition, the updated information shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or preparation within the preceding 12 months.
Poleg tega se posodobljene informacije zagotovi brezplačno na papirju ali v elektronski obliki vsem predhodnim prejemnikom, ki so jim dobavili snov ali pripravek v preteklih 12 mesecih.
Duty to communicate information on substances in articles
Obvezno sporočanje informacij o snoveh v izdelkih
Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.
Vsak dobavitelj izdelka, ki vsebuje snov v koncentraciji nad 0,1 % mas. m/m, ki izpolnjuje kriterije iz člena 57 in je opredeljena v skladu s členom 59(1), zagotovi prejemniku izdelka dovolj informacij za njegovo varno uporabo, ki so na voljo dobavitelju in ki vsebujejo vsaj ime snovi.
On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.
Vsak dobavitelj izdelka, ki vsebuje snov v koncentraciji nad 0,1 % mas. m/m, ki izpolnjuje kriterije iz člena 57 in je opredeljena v skladu s členom 59(1), zagotovi potrošniku na njegovo zahtevo dovolj informacij za varno uporabo izdelka, ki so na voljo dobavitelju in ki vsebujejo vsaj ime snovi.
The relevant information shall be provided, free of charge, within 45 days of receipt of the request.
Ustrezne informacije je treba brezplačno zagotoviti v 45 dneh po prejemu zahtevka.
Duty to communicate information on substances and preparations up the supply chain
Obvezno sporočanje informacij o snoveh in pripravkih po dobavni verigi navzgor
Any actor in the supply chain of a substance or a preparation shall communicate the following information to the next actor or distributor up the supply chain:
Vsak udeleženec dobavne verige snovi ali pripravka sporoči naslednjemu udeležencu ali distributerju, ki je v dobavni verigi na višji stopnji, naslednje informacije:
new information on hazardous properties, regardless of the uses concerned;
nove informacije o nevarnih lastnostih, ne glede na zadevne uporabe;
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.
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.
Distributors shall pass on that information to the next actor or distributor up the supply chain.
Distributerji te informacije sporočijo naslednjemu udeležencu ali distributerju iz dobavne verige, ki je na višji stopnji.
Access to information for workers
Dostopnost informacij delavcem
Workers and their representatives shall be granted access by their employer to the information provided in accordance with Articles 31 and 32 in relation to substances or preparations that they use or may be exposed to in the course of their work.
Delodajalci svojim delavcem in njihovim predstavnikom omogočijo dostop do informacij, zagotovljenih v skladu s členoma 31 in 32, o snoveh ali pripravkih, ki jih uporabljajo ali so jim lahko izpostavljeni med svojim delom.
Obligation to keep information
Obvezno shranjevanje informacij
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 po tem, 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 da na razpolago pristojnemu organu države članice, v kateri ima svoj sedež, ali Agenciji.
In the event of a registrant, downstream user or distributor ceasing activity, or transferring part or all of his operations to a third party, the party responsible for liquidating the registrant, downstream user or distributor's undertaking or assuming responsibility for the placing on the market of the substance or preparation concerned shall be bound by the obligation in paragraph 1 in place of the registrant, downstream user or distributor.
V primeru prenehanja dejavnosti registracijskega zavezanca, nadaljnjega uporabnika ali distributerja ali ob prenosu dela ali celote njegovih aktivnosti na tretjo stran, velja za stran, ki je odgovorna za likvidacijo podjetja registracijskega zavezanca, nadaljnjega uporabnika ali distributerja ali za prevzem odgovornosti za dajanje v promet zadevne snovi ali pripravka namesto registracijskega zavezanca, nadaljnjega uporabnika ali distributerja, dolžnost iz odstavka 1.
DOWNSTREAM USERS
NADALJNJI UPORABNIKI
Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures
Ocene kemijske varnosti nadaljnjih uporabnikov ter obvezna uporaba in priporočilo ukrepov za zmanjšanje tveganja
A downstream user or distributor may provide information to assist in the preparation of a registration.
Nadaljnji uporabnik ali distributer lahko zagotovita informacije, ki pomagajo pri pripravi registracije.
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 with a substance on its own or in a preparation with the aim of making this an identified use.
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 v pripravku, zato da bi ta postala navedena uporaba.
In making a use known, he shall provide sufficient information to allow the manufacturer, importer or downstream user who has supplied the substance, to prepare an exposure scenario, or if appropriate a use and exposure category, for his use in the manufacturer, importer or downstream user's chemical safety assessment.
Z obvestilom o uporabi proizvajalcu, uvozniku ali nadaljnjemu uporabniku, ki je snov dobavil, zagotovi zadostne informacije, da lahko pripravi predvideni scenarij izpostavljenosti ali, če je to ustrezno, kategorijo uporabe in izpostavljenosti za svojo uporabo v oceni kemijske varnosti proizvajalca, uvoznika ali nadaljnjega uporabnika.