natgillin/translations-raw huggingface dataset:
The Agency shall be bound by the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-Fraud Office (OLAF) (2) and shall issue, without delay, the appropriate provisions applicable to all of its staff.
Agencijo zavezuje Medinstitucionalni sporazum z dne 25. maja 1999 med Evropskim parlamentom, Svetom Evropske unije in Komisijo Evropskih skupnosti glede notranjih preiskav, ki jih opravlja Evropski urad za boj proti goljufijam (OLAF) (2), in brez odlašanja iz da ustrezne predpise, ki se uporabljajo za njeno celotno osebje.
Contacts with stakeholder organisations
Stik iz organizacijami zainteresiranih strani
Regulation No 1 of 15 April 1958 determining the languages to be used in the European Economic Community (1)
Za Agencijo se uporablja Uredba št. 1 z dne 15. aprila 1958 o določitvi jezikov, ki se uporabljajo v Evropski gospodarski skupnosti (1).
Article 110 shall apply to the Agency.
Člen 110
These rules of procedure shall be adopted by the Management Board, in agreement with the Commission.
Upravni odbor sprejmeta poslovnik v soglasju s Komisijo.
Members of the Management Board, members of the Committees and of the Forum, experts and officials and other servants of the Agency, shall be required, even after their duties have ceased, not to disclose information of the kind covered by the duty of professional secrecy.
Člani upravnega sveta, člani odborov in foruma, strokovnjaki ter uradni ki in drugi uslužbenci Agencije ne smejo niti po prenehanju svojih dolžnosti razkriti informacij, za katere velja obveznost varovanja poslovne skrivnosti.
The Executive Director, having consulted the Committee on Risk Assessment, the Committee on Socioeconomic Analysis and the Advisory Committee on Safety, Hygiene and Health Protection at Work, shall establish rules of procedure concerning worker protection issues.
Izvršni direktor po posvetovanju z Odborom za oceno tveganja, Odborom za socialnoekonomsko analizo in Svetovalnim odborom za varnost, higieno in varovanje zdravja pri delu sprejme poslovnik za vprašanja, povezana z varstvom pri delu.
(a) the identity(ies) of the manufacturer(s), producer(s) of articles or importer(s) responsible for placing the substance(s) on the market as specified in Section 1 of Annex VI;
dajejo v promet snov s področja uporabe člena 112, sporočijo Agenciji naslednje informacije, da jih ta vključi v popis v skladu s členom 114, razen če niso bile predložene že v okviru registracije:
(b) the identity of the substance(s) as specified in Sections 2.1 to 2.3.4 of Annex VI;
(b) identiteto snovi v skladu z deli 2.1 do 2.3.4 Priloge VI;
(c) the hazard classification of the substance(s), resulting from the application of Articles 4 and 6 of Directive 67/548/EEC;
(c) razvrstitev snovi glede na nevarne lastnosti, ki izhaja iz uporabe členov 4 in 6 Direktive 67/548/EGS;
(d) the hazard label for the substance(s), resulting from the application of Article 23(c) to (f), of Directive 67/548/EEC;
(d) označitev snovi kot nevarna, ki izhaja iz uporabe člena 23 (c) do (f) Direktive 67/548/EGS;
The Agency shall specify formats and make them available free of charge, and software packages and make them available on its website for any submissions to the Agency.
Za predložitev informacij Agencija določi oblike, ki jih da brezplačno na razpolago, in pakete programske opreme, ki jih dana razpolago na svoji spletni strani.
In particular, the Agency shall make available software tools to facilitate the submission of all information relating to substances registered in accordance with Article 12(1).
Agencija dana razpolago zlasti programsko opremo, da bi olajšala predložitev vseh informacij v zvezi s snovmi, registriranimi v skladu s členom 12(1).
(e) specific concentration limits, where applicable, resulting from the application of Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC.
(e) specifične mejne koncentracije, kjer je ustrezno, ki izhajajo iz uporabe člena 4(4) Direktive 67/548/EGS in členov 4 do 7 Direktive 1999/45/ES.
(a) any new scientific or technical information is generated which results in a change to the classification and labelling of the substance;
(a) se pridobijo nove znanstvene ali tehnične informacije, ki povzročijo spremembo v razvrstitvi in označitvi snovi;
(b) notifiers and registrants of differing entries for a single substance come to an agreed entry in accordance with paragraph 2.
(b) prijavitelji in registracijski zavezanci z različnimi vpisi za isto snov dosežejo sporazum o vpisu v skladu z odstavkom 2.
(b) substances within the scope of Article 1 of Directive 67/548/EEC, which meet the criteria for classification as dangerous in accordance with that Directive, and which a replaced on the market either on their own, or in a preparation above the concentration limits specified in Directive 1999/45/EC, where relevant, which results in the classification of the preparation as dangerous.
(b) snovi s področja uporabe člena 1 Direktive 67/548/EGS, ki izpolnjujejo kriterije za razvrstitev kot nevarne v skladu z navedeno direktivo ter se dajejo v promet kot take ali v pripravku, kadar koncentracije presegajo mejne vrednosti iz Direktive 1999/45/ES, kjer je to ustrezno, in se zato pripravek razvrsti kot nevaren.
Any manufacturer, producer of articles or importer, or group of manufacturers or producers of articles or importers, who place on the market a substance within the scope of Article 112, shall notify to the Agency the following informa-
Vsak proizvajalec, izdelovalec izdelkov ali uvoznik ali skupina proizvajalcev ali izdelovalcev izdelkov ali uvoznikov, ki
(b) whether, in respect of the entry, it is a joint entry between registrants of the same substance as per Article 11(1);
(a) ali obstaja za vpis usklajena razvrstitev in označitev naravni Skupnosti z vključitvijo v Prilogo I Direktive 67/548/EGS;
(c) if the entry differs from another entry on the inventory for the same substance;
(c) ali se vpis v popisu razlikuje od drugega vpisa za isto snov;
(d) the relevant registration number(s), if available.
(d) ustrezno(-e) številko(-e) registracije (registracij), če je (so) na voljo.
Every three years the Agency, in accordance with the objective of promoting non-animal testing methods, shall submit to the Commission a report on the status of implementation and use of non-animal test methods and testing strategies used to generate information on intrinsic properties and for risk assessment to meet the requirements of this Regulation.
Vsaka tri leta Agencija v skladu s ciljem za spodbujanje testnih metod brez testiranj na živalih predloži Komisiji poročilo o stanju na področju izvajanja in uporabe testnih metod brez testiranj na živalih in testnih strategij za pridobitev informacijo intrinzičnih lastnostih ter za oceno tveganja zaradi izpolnjevanja zahtev te uredbe.
(a) the experience acquired with the operation of this Regulation, including the information referred to in paragraphs 1,2 and 3 and;
(a) o izkušnjah, pridobljenih pri izvajanju te uredbe, vključno z informacijami iz odstavkov 1,2 in 3; ter
Harmonised classification and labelling at Community level shall, from 1 June 2007, normally be added to Annex I of Directive 67/548/EEC for classification of a substance as carcinogenic, mutagenic or toxic for reproduction category 1,2 or 3, or as a respiratory sensitiser.
Usklajeno razvrstitev in označitev naravni Skupnosti se od 1. junija 2007 običajno doda Prilogi I Direktive 67/548/EGS za snovi, ki so razvrščene kot rakotvorne, mutagene ali strupene za razmnoževanje skupine 1,2 ali 3, ali povzročajo preobčutljivosti dihal.
Harmonised classification and labelling for other effects may also be added to Annex I of Directive 67/548/EEC on a case-by-case basis if justification is provided demonstrating the need for action at Community level.
Prilogi I Direktive 67/548/EGS se lahko doda tudi usklajeno razvrstitev in označitev za druge učinke, odvisno od primera do primera, glede na to, ali je potreba po ukrepanju naravni Skupnosti utemeljena.
(b) the amount and distribution of funding made available by the Commission for the development and evaluation of alternative test methods.
(b) o višini in razdelitvi sredstev, ki jih je Komisija namenila za razvoj in evalvacijo alternativnih testnih metod.
Access to information
Prehodne ureditve
(a) details of the full composition of a preparation;
(a) podrobni podatki o popolni sestavi pripravka;
(b) 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;
(b) 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;
Every five years, Member States shall submit to the Commission a report on the operation of this Regulation in
Vsakih pet let države članice Komisiji predložijo poročilo o izvajanju te uredbe na njihovem ozemlju, ki vključuje tudi oddelke o evalvaciji in izvrševanju, kakor je opisano v členu 127.
(c) the precise tonnage of the substance or preparation manufactured or placed on the market;
(c) natančna tonaža snovi ali pripravka, ki se proizvede ali da v promet;
(d) links between a manufacturer or importer and his distributors or downstream users.
(d) povezave med proizvajalcem ali uvoznikom in njegovimi distributerji ali nadaljnjimi uporabniki.
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:
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:
(a) 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;
(a) če je to bistveno za razvrščanje in označevanje, stopnja čistote snovi ter določitev nečistot in/ali dodatkov, za katere je znano, da so nevarni;
(b) the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100 tonnes, 100 to 1 000 tonnes or over 1 000 tonnes) within which a particular substance has been registered;
(b) skupni razpon tonaže (tj. 1–10 ton, 10–100 ton, 100– 1 000 ton ali če z 1 000 ton), v katerem je bila določena snov registrirana;
(c) the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e);
(c) povzetki ali grobi povzetki študij v zvezi z informacijami iz odstavkov 1(d) in (e);
(d) information, other than that listed in paragraph 1, contained in the safety data sheet;
(d) informacije iz varnostnega lista, ki niso naštete v odstavku 1;
(e) the trade name(s) of the substance;
(e) trgovsko(-a) ime(-na) snovi;
(f) 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;
(f) ime po IUPAC nomenklaturi za nevarne snovi v smislu Direktive 67/548/EGS, ki niso v postopnem uvajanju, za obdobje treh let;
(g) 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:
(g) ime po IUPAC nomenklaturi za nevarne snovi v smislu Direktive 67/548/EGS, ki se uporabljajo samo v enega ali več naslednjih namenov:
(ii) in scientific research and development;
(ii) pri znanstvenih raziskavah in razvoju;
(a) 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);
(a) ime po IUPAC nomenklaturi za nevarne snovi v smislu Direktive 67/548/EGS brez poseganja v odstavka 2(f) in (g);
(iii) in product and process orientated research and development.
(iii) pri raziskavah in razvoju, usmerjenih v proizvode in postopke.
(b) if applicable, the name of the substance as given in EINECS;
(b) ime snovi iz seznama EINECS, če je primerno;
(c) the classification and labelling of the substance;
(c) razvrstitev in označitev snovi;
(d) physicochemical data concerning the substance and on pathways and environmental fate;
(d) fizikalno-kemijski podatki osnovi ter njeni porazdelitvi in obnašanju v okolju;
Cooperation with third countries and international organisations
(e) rezultat vsake toksikološke in ekotoksikološke študije;
(e) the result of each toxicological and ecotoxicological study;
Sodelovanje s tretjimi državami in mednarodnimi organizacijami
(f) any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I;
(f) vsak izpeljan DNEL (mejna vrednost, pod katero snov nima učinka) ali predvidena koncentracija brez učinka (PNEC), določena v skladu s Prilogo I;
(g) the guidance on safe use provided in accordance with Sections 4 and 5 of Annex VI;
(g) navodila za varno uporabo v skladu z oddelkoma 4 in 5 Priloge VI;
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 (1) or under Article 181a(3) of the Treaty, provided that both the following conditions are met:
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 (1) ali členom 181a(3) Pogodbe, če sta izpolnjena oba naslednja pogoja:
(h) 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.
(h) 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.
(a) the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation;
(a) namen sporazuma je sodelovanje pri izvajanju ali upravljanju zakonodaje o kemikalijah iz te uredbe;
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
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,
(b) the third party protects the confidential information as mutually agreed.
(b) tretja stran varuje zaupnost informacij na podlagi medsebojnega dogovora.
TITLE XIII other interested parties on the irrespective 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).
NASLOV XIII 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).
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 v so potrebno podporo, ki bi jim lahko koristila.
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 pajo obvestijo o vseh njihovih naknadnih spremembah.
Member States shall establish national helpdesks to provide advice to manufacturers, importers, downstream users and any
Države članice ustanovijo nacionalne službe za pomoč uporabnikom, ki proizvajalcem, uvoznikom, nadaljnjim uporabnikom
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, dane 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, daje 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.
(a) authorise the provisional measure for a time period defined in the decision; or
(a) začasni ukrep dovoli do roka, določenega v odločitvi; ali
(b) require the Member State to revoke the provisional measure.
(b) od države članice zahteva, da začasni ukrep prekliče.
(a) appoint personnel, including a person who shall fulfil the administrative functions of the Executive Director on an interim basis; and
(a) imenuje osebje, vključno z osebo, ki začasno izvaja naloge izvršnega direktorja; in
Amendments to the Annexes
Spremembe prilog lahko spremenijo v skladu s postopkom iz
The Annexes may be amended in accordance with the procedure referred to in Article 133(4).
Priloge se člena 133(4).
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 osnovi v skladu s členom 16(1) Direktive 67/548/EGS, velja kot odločitev, sprejeta v skladu s členom 52 te uredbe.
(a) any risk evaluation and recommended strategy for limiting risks that has been adopted at Community level in accordance with Article 11 of Regulation (EEC) No 793/93 as far as it includes proposals for restrictions in accordance with Title VIII of this Regulation but for which a decision under Directive 76/769/EEC has not yet been taken;
(a) vsako oceno tveganja in priporočeno strategijo za omejitev tveganj, sprejeto naravni Skupnosti v skladu s členom 11 Uredbe (EGS) št. 793/93, če ta vsebuje predloge za omejitve v skladu z naslovom VIII te uredbe, za katero pa odločitev v okviru Direktive 76/769/EGS še ni bila sprejeta;
(b) any proposal, which has been submitted to the relevant institutions but has not yet been adopted, concerning the introduction or the amendment of restrictions under Directive 76/769/EEC.
(b) vsakim predlogom, ki je bil predložen ustreznim institucijam in še ni bil sprejet ter se nanaša na uvedbo ali spremembe omejitev v skladu z Direktivo 76/769/EGS.
Until 1 June 2010, any dossier referred to in Article 129 (3) shall be submitted to the Commission.
Komisiji se do 1. junija 2010 predloži vsa dokumentacija iz člena 129(3).
(a) document information on hazard and risk in accordance with Annex XV, Part B of this Regulation;
(a) dokumentira informacije o nevarnosti in tveganju v skladu z delom B Priloge XV te uredbe;
(a) the costs for manufacturers and importers of drawing up the chemical safety reports;
(a) stroške, ki jih imajo proizvajalci in uvozniki pri pripravi poročilo kemijski varnosti;
(b) apply Article 69(4) of this Regulation on the basis of the information referred to in point (a); and
(b) uporabi člen 69(4) te uredbe na podlagi informacij iz točke (a); in
(b) the distribution of costs between actors in the supply chain and the downstream user;
(b) porazdelitev stroškov med udeleženci dobavne verige in nadaljnjimi uporabniki;
(c) 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.
(c) sestavi dokumentacijo o predlogih za reševanje vseh drugih prepoznanih tveganj z drugačnim ukrepanjem, kakor je sprememba Priloge XVII te uredbe.
(c) the benefits for human health and the environment.
(c) koristi za zdravje ljudi in okolje.
The information referred to above shall be submitted to the Agency by 1 December 2008.
Zgoraj omenjene 1. decembra 2008.
(a) the risks posed by polymers in comparison with other substances;
(a) tveganjih, ki jih predstavljajo polimeri v primerjavi z drugimi snovmi;
(b) the need, if any, to register certain types of polymer, taking account of competitiveness and innovation on the one hand and the protection of human health and the environment on the other.
(b) potrebi, če ta obstaja, po registriranju določenih vrst polimerov, ob upoštevanju konkurenčnosti in inovativnosti na eni strani ter varovanja zdravja ljudi in okolja na drugi.
On the basis of that review, the Commission may present legislative proposals to modify the information requirements for substances manufactured or imported in quantities of one tonne or more up to 10 tonnes per year per manufacturer or importer, taking into account the latest developments, for example in relation to alternative testing and (quantitative) structure activity relationships ((Q)SARs).
Na podlagi tega pregleda lahko Komisija predstavi zakonodajne predloge za spremembo zahtev po informacijah v zvezi s snovmi, ki se proizvedejo ali uvozijo v količinah, ki znašajo eno tono ali več do največ deset ton na leto na proizvajalca ali uvoznika, ob upoštevanju najnovejšega razvoja dogodkov, na primer v zvezi z alternativnimi testi in kvantitativnimi razmerji med strukturo in aktivnostjo ((Q)SAR).
References to the repealed acts shall be construed as references to this Regulation.
Sklicevanje na razveljavljene akte se šteje za sklicevanje nato uredbo.
GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS.......................................................................................................................
SPLOŠNE DOLOČBE ZA OCENJEVANJE SNOVI IN PRIPRAVO POROČILO KEMIJSKI VARNOSTI..................................................................................................................
GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS ...................................................
NAVODILA ZA PRIPRAVO VARNOSTNIH LISTOV ............................................................
EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a)...........................................................................................................................
IZJEME, ZA KATERE NE VELJA OBVEZNOST REGISTRACIJE V SKLADU S ČLENOM 2(7)(a) .....
EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b)...........................................................................................................................
IZJEME, ZA KATERE NE VELJA OBVEZNOST REGISTRACIJE V SKLADU S ČLENOM 2(7)(b) .....
INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10............................................
ZAHTEVE PO INFORMACIJAH IZ ČLENA 10....................................................................