natgillin/translations-raw huggingface dataset:
without prejudice to Article 7(6) and Article 64(2), the precise use, function or application of a substance or preparation, including information about its precise use as an intermediate;
brez poseganja v člen 7(6) in člen 64(2) natančen opis uporabe, namen uporabe ali aplikacija snovi ali pripravka, vključno z natančnimi informacijami o uporabi kot intermediata;
the precise tonnage of the substance or preparation manufactured or placed on the market;
natančna tonaža snovi ali pripravka, ki se proizvede ali da v promet;
links between a manufacturer or importer and his distributors or downstream users.
povezave med proizvajalcem ali uvoznikom in njegovimi distributerji ali nadaljnjimi uporabniki.
Where urgent action is essential to protect human health, safety or the environment, such as emergency situations, the Agency may disclose the information referred to in this paragraph.
Kadar je nujno takojšnje ukrepanje za zaščito zdravja ljudi, varnosti ali okolja, npr. v izrednih razmerah, lahko Agencija razkrije informacije iz tega odstavka.
The Management Board shall adopt the practical arrangements for implementing Regulation (EC) No 1049/2001, including appeals or remedies necessary for reviewing a partial or full rejection of a confidentiality request, by 1 June 2008.
Upravni odbor sprejme praktično ureditev za izvajanje Uredbe (ES) št. 1049/2001, skupaj s pritožbami ali sredstvi na voljo po delni ali popolni zavrnitvi zahteve za varovanje poslovnih skrivnosti, do 1. junija 2008.
Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may form the subject of a complaint to the Ombudsman or of an action before the Court of Justice, under the conditions laid down in Articles 195 and 230 of the Treaty respectively.
Proti odločitvam, ki jih Agencija sprejme na podlagi člena 8 Uredbe (ES) št. 1049/2001, se je mogoče pritožiti pri Varuhu človekovih pravic ali vložiti tožbo pri Sodišču, in sicer pod pogoji, določenimi v členih 195 in 230 Pogodbe.
Electronic public access
Elektronski dostop javnosti
The following information held by the Agency on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e):
Naslednje informacije, ki jih ima Agencija o snoveh kot takih, v pripravkih ali v izdelkih, so javnosti dostopne brezplačno na internetu v skladu s členom 77(2)(e):
the name in the IUPAC Nomenclature, for dangerous substances within the meaning of Directive 67/548/EEC, without prejudice to paragraph 2(f) and (g);
ime po IUPAC nomenklaturi za nevarne snovi v smislu Direktive 67/548/EGS brez poseganja v odstavka 2(f) in (g);
if applicable, the name of the substance as given in EINECS;
ime snovi iz seznama EINECS, če je primerno;
the classification and labelling of the substance;
razvrstitev in označitev snovi;
physicochemical data concerning the substance and on pathways and environmental fate;
fizikalno-kemijski podatki o snovi ter njeni porazdelitvi in obnašanju v okolju;
the result of each toxicological and ecotoxicological study;
rezultat vsake toksikološke in ekotoksikološke študije;
any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I;
vsak izpeljan DNEL (mejna vrednost, pod katero snov nima učinka) ali predvidena koncentracija brez učinka (PNEC), določena v skladu s Prilogo I;
the guidance on safe use provided in accordance with Sections 4 and 5 of Annex VI;
navodila za varno uporabo v skladu z oddelkoma 4 in 5 Priloge VI;
analytical methods if requested in accordance with Annexes IX or X which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans.
analitske metode, če se zahtevajo v skladu s Prilogo IX ali X, ki omogočajo zaznavanje nevarne snovi pri spuščanju v okolje ali določitev neposredne izpostavljenosti ljudi.
The following information on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e) except where a party submitting the information submits a justification in accordance with Article 10(a)(xi), accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned:
Naslednje informacije o snoveh kot takih, v pripravkih ali v izdelkih so javnosti dostopne brezplačno na internetu v skladu s členom 77(2)(e), razen kadar stran, ki predloži informacije, predloži utemeljitev v skladu s členom 10(a)(xi), ki jo Agencija sprejme kot utemeljeno, in sicer zakaj bi objava lahko škodila poslovnim interesom registracijskega zavezanca ali druge zadevne strani:
if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous;
če je to bistveno za razvrščanje in označevanje, stopnja čistote snovi ter določitev nečistot in/ali dodatkov, za katere je znano, da so nevarni;
the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100 tonnes, 100 to 1000 tonnes or over 1000 tonnes) within which a particular substance has been registered;
skupni razpon tonaže (tj. 1–10 ton, 10–100 ton, 100–1000 ton ali čez 1000 ton), v katerem je bila določena snov registrirana;
the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e);
povzetki ali grobi povzetki študij v zvezi z informacijami iz odstavkov 1(d) in (e);
information, other than that listed in paragraph 1, contained in the safety data sheet;
informacije iz varnostnega lista, ki niso naštete v odstavku 1;
the trade name(s) of the substance;
trgovsko(-a) ime(-na) snovi;
the name in the IUPAC Nomenclature for non-phase-in substances which are dangerous within the meaning of Directive 67/548/EEC for a period of six years;
ime po IUPAC nomenklaturi za nevarne snovi v smislu Direktive 67/548/EGS, ki niso v postopnem uvajanju, za obdobje treh let;
the name in the IUPAC Nomenclature for dangerous substances within the meaning of Directive 67/548/EEC that are only used as one or more of the following:
ime po IUPAC nomenklaturi za nevarne snovi v smislu Direktive 67/548/EGS, ki se uporabljajo samo v enega ali več naslednjih namenov:
as an intermediate;
kot intermediat;
in scientific research and development;
pri znanstvenih raziskavah in razvoju;
in product and process orientated research and development.
pri raziskavah in razvoju, usmerjenih v proizvode in postopke.
Cooperation with third countries and international organisations
Sodelovanje s tretjimi državami in mednarodnimi organizacijami
Notwithstanding Articles 118 and 119, information received by the Agency under this Regulation may be disclosed to any government or national authority of a third country or an international organisation in accordance with an agreement concluded between the Community and the third party concerned under Regulation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals [56] or under Article 181a(3) of the Treaty, provided that both the following conditions are met:(a) the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation;
Ne glede na člena 118 in 119 se informacije, ki jih prejme Agencija v skladu s to uredbo, lahko razkrijejo vladi ali organu tretje države ali mednarodni organizaciji na podlagi sporazuma, sklenjenega med Skupnostjo in zadevno tretjo stranjo v skladu z Uredbo (ES) št. 304/2003 Evropskega parlamenta in Sveta z dne 28. januarja 2003 o izvozu in uvozu nevarnih kemikalij [56] ali členom 181a(3) Pogodbe, če sta izpolnjena oba naslednja pogoja:(a) namen sporazuma je sodelovanje pri izvajanju ali upravljanju zakonodaje o kemikalijah iz te uredbe;
the third party protects the confidential information as mutually agreed.
tretja stran varuje zaupnost informacij na podlagi medsebojnega dogovora.
Member States shall appoint the competent authority or competent authorities responsible for performing the tasks allotted to competent authorities under this Regulation and for cooperating with the Commission and the Agency in the implementation of this Regulation.
Države članice imenujejo pristojni organ ali pristojne organe, odgovorne za izvajanje nalog, ki se jim dodelijo v skladu s to uredbo, ter za sodelovanje s Komisijo in Agencijo pri izvajanju te uredbe.
Member States shall place adequate resources at the disposal of the competent authorities to enable them, in conjunction with any other available resources, to fulfil their tasks under this Regulation in a timely and effective manner.
Države članice pristojnim organom zagotovijo ustrezna sredstva, s katerimi se jim v povezavi z vsemi drugimi razpoložljivimi viri omogoči pravočasno in učinkovito izvajanje njihovih nalog iz te uredbe.
The competent authorities shall cooperate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States all the necessary and useful support to this end.
Pristojni organi medsebojno sodelujejo pri izvajanju svojih nalog iz te uredbe in nudijo pristojnim organom drugih držav članic v ta namen vso potrebno podporo, ki bi jim lahko koristila.
Communication to the public of information on risks of substances
Obveščanje javnosti o nevarnostih snovi
The competent authorities of the Member States shall inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment.
Pristojni organi držav članic obveščajo javnost o tveganjih, ki jih snovi povzročajo, če je to po njihovem mnenju potrebno za varovanje zdravja ljudi ali okolja.
The Agency, in consultation with competent authorities and stakeholders and drawing as appropriate on relevant best practice, shall provide guidance for the communication of information on the risks and safe use of chemical substances, on their own, in preparations or in articles, with a view to coordinating Member States in these activities.
Agencija po posvetovanju s pristojnimi oblastmi in interesnimi skupinami ter z ustreznim zgledovanjem na najboljše razpoložljive prakse pripravi smernice za sporočanje podatkov o nevarnostih in varni uporabi kemijskih snovi kot takih, v pripravku ali v izdelkih, z namenom usklajevanja teh dejavnosti med državami članicami.
Other responsibilities
Druge obveznosti
Competent authorities shall submit electronically to the Agency any available information that they hold on substances registered in accordance with Article 12(1) whose dossiers do not contain the full information referred to in Annex VII, in particular whether enforcement or monitoring activities have identified suspicions of risk.
Pristojni organi Agenciji v elektronski obliki predložijo vse razpoložljive informacije, ki jih imajo o snoveh, registriranih v skladu s členom 12(1) in katerih dokumentacija ne vsebuje popolnih informacij iz Priloge VII, zlasti o tem, če je bilo med izvrševanjem ali monitoringom prepoznano sumljivo tveganje.
The competent authority shall update this information as appropriate.
Pristojni organ te informacije posodobi, kakor je primerno.
Member States shall establish national helpdesks to provide advice to manufacturers, importers, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation, in particular in relation to the registration of substances in accordance with Article 12(1), in addition to the operational guidance documents provided by the Agency under Article 77(2)(g).
Države članice ustanovijo nacionalne službe za pomoč uporabnikom, ki proizvajalcem, uvoznikom, nadaljnjim uporabnikom in vsem drugim zainteresiranim stranem svetujejo o njihovih odgovornostih oziroma obveznostih iz te uredbe, zlasti glede registracije snovi v skladu s členom 12(1), dodatno z operativnimi smernicami, ki jih zagotovi Agencija v skladu s členom 77(2)(g).
ENFORCEMENT
IZVRŠEVANJE
Tasks of the Member States
Naloge držav članic
Member States shall maintain a system of official controls and other activities as appropriate to the circumstances.
Države članice vzdržujejo sistem uradnih preverjanj in drugih dejavnosti glede na okoliščine.
Penalties for non-compliance
Kazni za kršitve
Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented.
Države članice določijo kazenske določbe, ki se uporabljajo za kršitve določb te uredbe, in sprejmejo vse potrebne ukrepe za njihovo izvajanje.
The Member States shall notify those provisions to the Commission no later than 1 December 2008 and shall notify it without delay of any subsequent amendment affecting them.
Države članice obvestijo Komisijo o teh določbah najpozneje do 1. decembra 2008, nemudoma pa jo obvestijo o vseh njihovih naknadnih spremembah.
The report referred to in Article 117(1) shall, in relation to enforcement, include the results of the official inspections, the monitoring carried out, the penalties provided for and the other measures taken pursuant to Articles 125 and 126 during the previous reporting period.
Poročilo iz člena 117(1) v povezavi z izvajanjem vsebuje rezultate uradnih preverjanj, opravljenega spremljanja, določene kazni in druge ukrepe, sprejete v skladu s členoma 125 in 126 med predhodnim poročevalskim obdobjem.
The common issues to be covered in the reports shall be agreed by the Forum.
Forum se dogovori, katera skupna vprašanja je treba vključiti v poročila.
The Commission shall make these reports available to the Agency and the Forum.
Komisija da ta poročila na razpolago Agenciji in forumu.
Free movement
Prosti pretok
Subject to paragraph 2, Member States shall not prohibit, restrict or impede the manufacturing, import, placing on the market or use of a substance, on its own, in a preparation or in an article, falling within the scope of this Regulation, which complies with this Regulation and, where appropriate, with Community acts adopted in implementation of this Regulation.
Države članice ob upoštevanju odstavka 2 ne prepovedo, omejijo ali ovirajo proizvodnje, uvoza, dajanja v promet ali uporabe snovi kot take, v pripravku ali izdelku, ki spada na področje uporabe te uredbe in je v skladu s to uredbo in, kjer je ustrezno, z akti Skupnosti, sprejetimi za izvajanje te uredbe.
Nothing in this Regulation shall prevent Member States from maintaining or laying down national rules to protect workers, human health and the environment applying in cases where this Regulation does not harmonise the requirements on manufacture, placing on the market or use.
Državam članicam nič v tej uredbi ne preprečuje, da ne bi obdržale ali določile nacionalna pravila za varovanje delavcev, zdravja ljudi in okolja, za uporabo v primerih, ko ta uredba ne usklajuje zahtev glede proizvodnje, dajanja na trg ali uporabe.
Where a Member State has justifiable grounds for believing that urgent action is essential to protect human health or the environment in respect of a substance, on its own, in a preparation or in an article, even if satisfying the requirements of this Regulation, it may take appropriate provisional measures.
Država članica lahko sprejme ustrezne začasne ukrepe, če ima utemeljene razloge za mnenje, da je nujno takojšnje ukrepanje za varovanje zdravja ljudi ali okolja v povezavi s snovjo kot tako, v pripravku ali izdelku, četudi ta izpolnjuje zahteve iz te uredbe.
The Member State shall immediately inform the Commission, the Agency and the other Member States thereof, giving reasons for its decision and submitting the scientific or technical information on which the provisional measure is based.
Država članica o tem takoj obvesti Komisijo, Agencijo in druge države članice, pri tem navede razloge za svojo odločitev ter predloži znanstvene ali tehnične informacije, na katerih temelji začasni ukrep.
The Commission shall take a decision in accordance with the procedure referred to in Article 133(3) within 60 days of receipt of the information from the Member State.
Komisija sprejme odločitev v skladu s postopkom iz člena 133(3) v 60 dneh po prejemu obvestila države članice.
This decision shall either:
S to odločitvijo se:
authorise the provisional measure for a time period defined in the decision; or
začasni ukrep dovoli do roka, določenega v odločitvi; ali
require the Member State to revoke the provisional measure.
od države članice zahteva, da začasni ukrep prekliče.
If, in the case of a decision as referred to in paragraph 2(a), the provisional measure taken by the Member State consists in a restriction on the placing on the market or use of a substance, the Member State concerned shall initiate a Community restrictions procedure by submitting to the Agency a dossier, in accordance with Annex XV, within three months of the date of the Commission decision.
Če začasni ukrep, ki ga sprejme država članica, v primeru odločitve iz točke (a) odstavka 2 pomeni omejitev dajanja v promet ali uporabe snovi, zadevna država članica sproži postopek Skupnosti za sprejetje omejitev tako, da Agenciji v treh mesecih po datumu odločitve Komisije predloži dokumentacijo v skladu s Prilogo XV.
In the case of a decision as referred to in paragraph 2(a), the Commission shall consider whether this Regulation needs to be adapted.
V primeru odločitve iz točke (a) odstavka 2 Komisija preuči, ali je treba to uredbo prilagoditi.
Statement of reasons for decisions
Utemeljitev odločitev
The competent authorities, the Agency and the Commission shall state the reasons for all decisions they take under this Regulation.
Pristojni organi, Agencija in Komisija navedejo razloge za vse odločitve, ki jih sprejmejo v skladu s to uredbo.
The Annexes may be amended in accordance with the procedure referred to in Article 133(4).
Priloge se lahko spremenijo v skladu s postopkom iz člena 133(4).
Implementing legislation
Izvedbeni predpisi
The measures necessary to put the provisions of this Regulation efficiently into effect shall be adopted in accordance with the procedure referred to in Article 133(3).
Ukrepi, potrebni za učinkovito izvajanje določb te uredbe, se sprejmejo v skladu s postopkom iz člena 133(3).
Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Pri sklicevanju na ta odstavek se uporabljata člena 5a(1) do (4) in 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.
Preparation of establishment of the Agency
Priprave na ustanovitev Agencije
The Commission shall afford the necessary support towards the establishment of the Agency.
Komisija zagotovi potrebno podporo pri ustanavljanju Agencije.
For that purpose, until such time as the Executive Director takes up his duties following his appointment by the Management Board of the Agency in accordance with Article 84, the Commission, on behalf of the Agency, and using the budget provided for the latter, may:
Za ta namen in vse dokler izvršni direktor ne prevzame dolžnosti po imenovanju upravnega odbora Agencije v skladu s členom 84 lahko Komisija v imenu Agencije in z uporabo proračuna, predvidenega za Agencijo:
appoint personnel, including a person who shall fulfil the administrative functions of the Executive Director on an interim basis; and
imenuje osebje, vključno z osebo, ki začasno izvaja naloge izvršnega direktorja; in
conclude other contracts.
sklepa druge pogodbe.
Transitional measures regarding notified substances
Prehodni ukrepi v zvezi s prijavljenimi snovmi
The requests to notifiers to provide further information to the competent authority in accordance with Article 16(2) of Directive 67/548/EEC, shall be considered as decisions adopted in accordance with Article 51 of this Regulation.
Zahteve za prijavitelje, naj pristojnemu organu zagotovijo nadaljnje informacije v skladu s členom 16(2) Direktive 67/548/EGS, bodo veljale kot odločitve, sprejete v skladu s členom 51 te uredbe.
The requests to a notifier to provide further information for a substance in accordance with Article 16(1) of Directive 67/548/EEC, shall be considered as decisions adopted in accordance with Article 52 of this Regulation.
Zahteva za prijavitelja, naj zagotovi nadaljnje informacije o snovi v skladu s členom 16(1) Direktive 67/548/EGS, velja kot odločitev, sprejeta v skladu s členom 52 te uredbe.
Such substance shall be regarded as being included in the Community rolling action plan in accordance with Article 44(2) of this Regulation and shall be regarded as being chosen in accordance with Article 45(2) of this Regulation by the Member State whose competent authority has requested further information in accordance with Article 7(2) and Article 16(1) of Directive 67/548/EEC.
Takšna snov velja za vključeno v tekoči akcijski načrt Skupnosti v skladu s členom 44(2) te uredbe in izbrano v skladu s členom 45(2) te uredbe s strani držav članic, katerih pristojni organ je zahteval nadaljnje informacije v skladu s členom 7(2) in členom 16(1) Direktive 67/548/EGS.
Transitional measures regarding existing substances
Prehodni ukrepi v zvezi z obstoječimi snovmi
The requests to manufacturers and importers to submit information to the Commission made by a Commission Regulation in application of Article 10(2) of Regulation (EEC) No 793/93, shall be considered as decisions adopted in accordance with Article 52 of this Regulation.
Zahteve za proizvajalce in uvoznike, naj Komisiji predložijo informacije, veljajo kot odločitve, sprejete v skladu s členom 52 te uredbe; te zahteve izvirajo iz uredbe Komisije pri uporabi člena 10(2) Uredbe (EGS) št. 793/93.
The competent authority for the substance shall be the competent authority from the Member State identified as rapporteur in accordance with Article 10(1) of Regulation (EEC) No 793/93 and shall carry out the tasks of Article 46(3) and Article 48 of this Regulation.
Pristojni organ za snov je pristojni organ iz države članice, ki je opredeljen kot poročevalec v skladu s členom 10(1) Uredbe (EGS) št. 793/93 in izvaja naloge iz člena 46(3) in člena 48 te uredbe.
The requests to manufacturers and importers to submit information to the Commission made by a Commission Regulation in application of Article 12(2) of Regulation (EEC) No 793/93, shall be considered as decisions adopted in accordance with Article 52 of this Regulation.
Zahteve za proizvajalce in uvoznike, naj Komisiji predložijo informacije, veljajo kot odločitve, sprejete v skladu s členom 52 te uredbe; te zahteve izvirajo iz uredbe Komisije pri uporabi člena 12(2) Uredbe (EGS) št. 793/93.
The Agency shall identify the competent authority for the substance to carry out the tasks of Article 46(3) and Article 48 of this Regulation.
Agencija opredeli organ, pristojen za snov, za izvajanje nalog iz členov 46(3) in 48 te uredbe.
A Member State whose rapporteur has not forwarded by 1 June 2008 the risk evaluation and, where appropriate, the strategy for limiting the risks, in accordance with Article 10(3) of Regulation (EEC) No 793/93, shall:
Država članica, katere poročevalec ni posredoval ocene tveganja do 1. junija 2008 in, kjer je to primerno, strategije za omejitev tveganj v skladu s členom 10(3) Uredbe (EGS) št. 793/93:
document information on hazard and risk in accordance with Annex XV, Part B of this Regulation;
dokumentira informacije o nevarnosti in tveganju v skladu z delom B Priloge XV te uredbe;
apply Article 69(4) of this Regulation on the basis of the information referred to in point (a); and
uporabi člen 69(4) te uredbe na podlagi informacij iz točke (a); in
prepare a documentation of how it considers that any other risks identified would need to be addressed by action other than an amendment of Annex XVII of this Regulation.
sestavi dokumentacijo o predlogih za reševanje vseh drugih prepoznanih tveganj z drugačnim ukrepanjem, kakor je sprememba Priloge XVII te uredbe.
The information referred to above shall be submitted to the Agency by 1 December 2008.
Zgoraj omenjene informacije se predložijo Agenciji do 1. decembra 2008.