natgillin/translations-raw huggingface dataset:
substances on their own or in preparations, registered in accordance with Title II, exported from the Community by an actor in the supply chain and re-imported into the Community by the same or another actor in the same supply chain who shows that:
snovi kot take ali v pripravkih, registrirane v skladu z naslovom II, ki jih udeleženec dobavne verige izvozi iz Skupnosti, nazaj v Skupnost pa jih ponovno uvozi isti ali drug udeleženec iste dobavne verige, ki dokaže:
the substance being re-imported is the same as the exported substance;
da je snov, ki naj bi se ponovno uvozila, ista kot izvožena snov;
he has been provided with the information in accordance with Articles 31 or 32 relating to the exported substance;
da je za izvoženo snov dobil informacije v skladu s členom 31 ali 32;
substances, on their own, in preparations or in articles, which have been registered in accordance with Title II and which are recovered in the Community if:
snovi kot take, v pripravkih ali izdelkih, ki so bile registrirane v skladu z naslovom II in ki so predelane v Skupnosti, če:
the substance that results from the recovery process is the same as the substance that has been registered in accordance with Title II; and
je snov, ki je nastala v procesu predelave, ista kot snov, ki je bila registrirana v skladu z naslovom II; in
the information required by Articles 31 or 32 relating to the substance that has been registered in accordance with Title II is available to the establishment undertaking the recovery.
ima predelovalni obrat na voljo informacije, zahtevane v skladu s členom 31 ali 32 v zvezi s snovjo, ki je bila registrirana v skladu z naslovom II.
On-site isolated intermediates and transported isolated intermediates shall be exempted from:
Na mestu izolirani intermediati ali transportirani izolirani intermediati se izvzamejo iz:
Chapter 1 of Title II, with the exception of Articles 8 and 9; and
poglavja 1 naslova II, razen členov 8 in 9; in
Title VII.
naslova VII.
The provisions of Titles II and VI shall not apply to polymers.
Določbe naslovov II in VI se ne uporabljajo za polimere.
Definitions and general provision
Opredelitve in splošna določba
substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;
Snov: pomeni kemijski element in njegove spojine v naravnem stanju ali pridobljene s kakršnim koli proizvodnim procesom, vključno z vsemi dodatki, potrebnimi za ohranitev njene obstojnosti, in vsemi nečistotami, ki nastanejo pri uporabljenem procesu, ne vključuje pa topil, ki se lahko izločijo, ne da bi to vplivalo na obstojnost snovi ali spremenilo njeno sestavo.
preparation: means a mixture or solution composed of two or more substances;
Pripravek: pomeni zmes ali raztopino, sestavljeno iz dveh ali več snovi.
article: means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;
Izdelek: pomeni predmet, ki med proizvodnjo dobi posebno obliko ali površino, ki bolj določa njegovo funkcijo kot njegova kemična sestava.
producer of an article: means any natural or legal person who makes or assembles an article within the Community;
Izdelovalec izdelka: pomeni fizično ali pravno osebo, ki izdeluje ali sestavlja izdelek v Skupnosti.
polymer: means a substance consisting of molecules characterised by the sequence of one or more types of monomer units.
Polimer: pomeni snov, sestavljeno iz molekul, za katere je značilno zaporedje ene ali več vrst monomernih enot.
Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units.
Takšne molekule morajo biti porazdeljene v okviru določenega razpona molekulske mase, pri čemer se razlike v molekulski masi lahko pripišejo predvsem razlikam v številu monomernih enot.
A polymer comprises the following:
Polimer vsebuje:
a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;
navadno masno večino molekul z vsaj tremi monomernimi enotami, ki so s kovalentno vezjo povezane vsaj še z eno drugo monomerno enoto ali drugim reaktantom;
less than a simple weight majority of molecules of the same molecular weight.
manj kot navadno masno večino molekul z enako molekulsko maso.
In the context of this definition a ‘monomer unit’ means the reacted form of a monomer substance in a polymer;
V okviru te opredelitve pomeni „monomerna enota“ vezano obliko monomerne snovi v polimeru.
monomer: means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;
Monomer: pomeni snov, ki je zmožna tvoriti kovalentne vezi z zaporedjem dodatnih podobnih ali drugačnih molekul, pod pogoji ustrezne reakcije, pri kateri se tvorijo polimeri, in se uporablja za ta posebni proces.
registrant: means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance;
Registracijski zavezanec: pomeni proizvajalca ali uvoznika snovi oz. izdelovalca ali uvoznika izdelka, ki predloži registracijo snovi.
manufacturing: means production or extraction of substances in the natural state;
Proizvodnja: pomeni proizvodnjo ali ekstrakcijo snovi v naravnem stanju.
manufacturer: means any natural or legal person established within the Community who manufactures a substance within the Community;
Proizvajalec: pomeni fizično ali pravno osebo s stalnim bivališčem oziroma sedežem v Skupnosti, ki proizvaja snov v Skupnosti.
import: means the physical introduction into the customs territory of the Community;
Uvoz: pomeni fizični vnos na carinsko območje Skupnosti.
importer: means any natural or legal person established within the Community who is responsible for import;
Uvoznik: pomeni fizično ali pravno osebo s stalnim bivališčem oziroma sedežem v Skupnosti, ki je odgovorna za uvoz.
placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third party.
Dajanje v promet: pomeni dobavo ali prepustitev tretjemu za plačilo ali neodplačno.
Import shall be deemed to be placing on the market;
Uvoz se šteje za dajanje v promet.
downstream user: means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities.
Nadaljnji uporabnik: pomeni fizično ali pravno osebo s stalnim bivališčem oziroma sedežem v Skupnosti, ki ni proizvajalec ali uvoznik in uporablja snov kot tako ali v pripravku pri svoji industrijski ali poklicni dejavnosti.
A distributor or a consumer is not a downstream user.
Distributer ali potrošnik ni nadaljnji uporabnik.
A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user;
Ponovni uvoznik, izvzet v skladu s členom 2(7)(c), se šteje za nadaljnjega uporabnika.
distributor: means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a preparation, for third parties;
Distributer: pomeni fizično ali pravno osebo s stalnim bivališčem oziroma sedežem v Skupnosti, vključno s trgovcem na drobno, ki snov kot tako ali v pripravku samo skladišči in daje v promet za tretje osebe.
intermediate: means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis):
Intermediat: pomeni snov, ki se proizvede in porabi ali uporabi pri kemijskem procesu za pretvorbo v drugo snov (v nadaljevanju „sinteza“):
non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place.
neizoliran intermediat: pomeni intermediat, ki se med sintezo ne odstrani namerno (razen za vzorčenje) iz opreme, v kateri poteka sinteza.
Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;
Takšna oprema vključuje reakcijsko posodo, njeno pomožno opremo in vso opremo, skozi katero gre(-do) snov(-i) med neprekinjenim ali saržnim procesom, ter cevi za prenos iz ene posode v drugo za naslednjo reakcijsko fazo, ne vključuje pa cistern ali drugih posod, v katerih se snov(-i) hrani(-jo) po proizvodnji;
on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities;
na mestu izoliran intermediat: pomeni intermediat, ki ne izpolnjuje kriterijev za neizolirani intermediat, pri čemer proizvodnja intermediata in sinteza druge(-ih) snovi iz tega intermediata potekata na istem mestu, izvaja pa ju ena ali več pravnih subjektov;
transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites;
transportiran izoliran intermediat: pomeni intermediat, ki ne izpolnjuje kriterijev za neizoliran intermediat, ki se prepelje z enega mesta na drugo mesto oziroma prepelje z drugega mesta.
site: means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared;
Mesto: pomeni določeno lokacijo, kjer si, če je proizvajalcev snovi več, ti delijo določeno infrastrukturo in naprave.
actors in the supply chain: means all manufacturers and/or importers and/or downstream users in a supply chain;
Udeleženci dobavne verige: pomeni vse proizvajalce in/ali uvoznike ter/ali nadaljnje uporabnike dobavne verige.
Agency: means the European Chemicals Agency as established by this Regulation;
Agencija: pomeni Evropsko agencijo za kemikalije, kakor je ustanovljena s to uredbo.
competent authority: means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation;
Pristojni organ: pomeni organ ali organe, ki jih ustanovijo države članice za izvajanje obveznosti iz te uredbe.
phase-in substance: means a substance which meets at least one of the following criteria:
Snov v postopnem uvajanju: pomeni snov, ki izpolnjuje vsaj enega od naslednjih kriterijev:
it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);
snov je vpisana na Evropskem seznamu obstoječih kemijskih snovi (EINECS);
it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this;
snov se je proizvajala v Skupnosti ali v državah, ki so k Evropski uniji pristopile 1. januarja 1995 ali 1. maja 2004, vendar pa je proizvajalec ali uvoznik ni dajal v promet, in sicer vsaj enkrat v 15 letih pred začetkom veljavnosti te uredbe, pod pogojem, da ima proizvajalec ali uvoznik o tem dokumentarna dokazila;
it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this;
snov je proizvajalec ali uvoznik dal v promet v Skupnosti ali v državah, ki so k Evropski uniji pristopile 1. januarja 1995 ali 1. maja 2004, pred začetkom veljavnosti te uredbe in je veljala za prijavljeno v skladu s prvo alineo člena 8(1) Direktive 67/548/EGS, a ne ustreza opredelitvi polimera iz te uredbe, pod pogojem, da ima proizvajalec ali uvoznik o tem dokumentarna dokazila.
notified substance: means a substance for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/EEC;
Prijavljena snov: pomeni snov, za katero je bila predložena prijava in ki se lahko da v promet v skladu z Direktivo 67/548/EGS.
product and process orientated research and development: means any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance;
V proizvod in proces usmerjene raziskave in razvoj: pomeni vsak znanstveni razvoj, povezan z razvojem proizvoda ali nadaljnjim razvojem snovi kot take, pripravkov ali izdelkov, pri čemer se za razvoj proizvodnega procesa in/ali za test področja uporabe snovi uporabijo poskusni proizvodni obrat ali proizvodni testi.
scientific research and development: means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year;
Znanstvene raziskave in razvoj: pomeni znanstvene teste, analize ali kemijske raziskave, ki potekajo pod nadzorovanimi pogoji s količino, ki je manjša od ene tone na leto.
use: means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;
Uporaba pomeni predelavo, formulacijo, porabo, hrambo, posedovanje, obdelavo, polnjenje v posode, prenos iz ene posode v drugo, mešanje, izdelavo izdelka ali katero koli drugo uporabo.
registrant's own use: means an industrial or professional use by the registrant;
Lastna uporaba registracijskega zavezanca: pomeni uporabo registracijskega zavezanca v industrijske ali poklicne namene.
identified use: means a use of a substance on its own or in a preparation, or a use of a preparation, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user;
Opredeljena uporaba: pomeni uporabo snovi kot take ali v pripravku ali uporabo pripravka, ki jo določi udeleženec dobavne verige, vključno z njegovo lastno uporabo, ali ki jo pisno sporoči neposredni nadaljnji uporabnik.
full study report: means a complete and comprehensive description of the activity performed to generate the information.
Celovito poročilo o študiji: pomeni popolni in obsežni opis dejavnosti, opravljene za pridobitev informacij.
This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test house describing the study performed;
To zajema celotno znanstveno poročilo, kot je bilo objavljeno v literaturi, z opisom izvedene študije, ali celovito poročilo, ki ga je pripravil laboratorij, z opisom izvedene študije.
robust study summary: means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report;
Grob povzetek študije: pomeni podroben povzetek ciljev, metod, rezultatov in zaključkov iz celovitega poročila o študiji, ki zagotavlja dovolj informacij za izvedbo neodvisne ocene študije in čim bolj zmanjša potrebo po preverjanju v celovitem poročilu o študiji.
study summary: means a summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study;
Študijski povzetek: pomeni povzetek ciljev, metod, rezultatov in zaključkov iz celovitega študijskega poročila, ki zagotavlja dovolj informacij za izvedbo ocene ustreznosti študije.
per year: means per calendar year, unless stated otherwise, for phase-in substances that have been imported or manufactured for at least three consecutive years, quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years;
Na leto: pomeni na koledarsko leto, če ni drugače navedeno, za snovi v postopnem uvajanju, ki se uvažajo ali proizvajajo vsaj tri leta zapored, se letne količine izračunajo na podlagi povprečja obsega proizvodnje ali uvoza iz treh predhodnih koledarskih let.
restriction: means any condition for or prohibition of the manufacture, use or placing on the market;
Omejitev: pomeni vsak pogoj za ali prepoved proizvodnje, uporabe ali dajanja v promet.
supplier of a substance or a preparation: means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a preparation, or a preparation;
Dobavitelj snovi ali pripravka: pomeni vsakega proizvajalca, uvoznika, nadaljnjega uporabnika ali distributerja, ki daje v promet snov kot tako ali v pripravku ali pripravek.
supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market;
Dobavitelj izdelka: pomeni vsakega izdelovalca ali uvoznika izdelka, distributerja ali drugega udeleženca dobavne verige, ki daje izdelek na trg.
recipient of a substance or a preparation: means a downstream user or a distributor being supplied with a substance or a preparation;
Prejemnik snovi ali pripravka: pomeni nadaljnjega uporabnika ali distributerja, kateremu je dobavljena snov ali pripravek.
recipient of an article: means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers;
Prejemnik izdelka: pomeni industrijskega ali poklicnega uporabnika ali distributerja, ki se oskrbuje z izdelkom, pri čemer to ne vključuje potrošnikov.
SME: means small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises [38];
MSP: pomeni mala in srednje velika podjetja, kakor so opredeljena v Priporočilu Komisije z dne 6. maja 2003 o opredelitvi mikro, malih in srednje velikih podjetij [38].
exposure scenario: means the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment.
Scenarij izpostavljenosti: pomeni sklop pogojev, vključno z delovnimi pogoji in ukrepi za obvladovanje tveganja, ki opisujejo, kako se snov proizvaja ali uporablja v svojem življenjskem ciklu in kako proizvajalec ali uvoznik nadzira izpostavljenost ljudi in okolja ali pa takšen nadzor priporoča nadaljnjim uporabnikom.
These exposure scenarios may cover one specific process or use or several processes or uses as appropriate;
Ti scenariji izpostavljenosti lahko zajemajo določen proces ali uporabo oz. več procesov ali uporab, kakor je primerno.
use and exposure category: means an exposure scenario covering a wide range of processes or uses, where the processes or uses are communicated, as a minimum, in terms of the brief general description of use;
Kategorija uporabe in izpostavljenosti: pomeni scenarij izpostavljenosti, ki zajema številne procese ali uporabe, ko se ti procesi ali uporabe sporočajo vsaj v obliki kratkega splošnega opisa uporabe.
substances which occur in nature: means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means;
Snovi, ki se nahajajo v naravi: pomeni naravno nastalo snov kot tako, nepredelano ali predelano le na ročen, mehanski ali gravitacijski način, z raztapljanjem v vodi, s flotacijo, z izločevanjem z vodo, z destilacijo z vodno paro ali segrevanjem izključno za odstranjevanje vode, ali snov, ki je izločena iz zraka na kakršen koli način.
not chemically modified substance: means a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities;
Snov, ki ni kemijsko spremenjena: pomeni snov, katere kemijska struktura ostaja nespremenjena, tudi če je bila v kemijskem procesu ali obdelavi ali v fizikalnem procesu minerološke pretvorbe, na primer za odstranitev nečistot.
alloy: means a metallic material, homogenous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means.
Zlitina: pomeni kovinsko snov, ki je homogena v makroskopskem merilu in ki je sestavljena iz dveh ali več elementov, združenih tako, da jih ni mogoče ločiti enostavno z mehaničnimi sredstvi.
Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users.
Proizvajalec, uvoznik ali, kjer je to ustrezno, nadaljnji uporabnik lahko ob tem, da je še naprej polno odgovoren za izpolnjevanje svojih obveznosti po tej uredbi, imenuje zastopnika tretje strani za vse postopke iz člena 11, člena 19, naslova III in člena 53, ki zadevajo razgovore z drugimi proizvajalci, uvozniki ali, kjer je to ustrezno, z ustreznimi nadaljnjimi uporabniki.
In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users.
V teh primerih Agencija običajno ne razkrije istovetnosti proizvajalca ali uvoznika ali nadaljnjega uporabnika, ki je imenoval zastopnika, drugim proizvajalcem, uvoznikom ali, kjer je to ustrezno, nadaljnjim uporabnikom.
REGISTRATION OF SUBSTANCES
REGISTRACIJA SNOVI
General obligation to register and information requirements
Splošna obveznost registriranja in zahteve glede obveščanja
No data, no market
Brez podatkov ni trga
Subject to Articles 6, 7, 21 and 23, substances on their own, in preparations or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required.
Ob upoštevanju členov 6, 7, 21 in 23 se snovi kot take, v pripravkih ali v izdelkih v Skupnosti ne smejo proizvajati ali dati v promet, če niso bile registrirane v skladu z ustreznimi določbami tega naslova, če se to zahteva.
General obligation to register substances on their own or in preparations
Splošna obveznost registriranja snovi kot takih ali v pripravkih
Save where this Regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in one or more preparation(s), in quantities of one tonne or more per year shall submit a registration to the Agency.
Razen če ta uredba določa drugače, vsak proizvajalec ali uvoznik snovi kot take ali v enem ali več pripravkih v količini, ki znaša eno tono ali več na leto, Agenciji predloži registracijo.