natgillin/translations-raw huggingface dataset:
snovi kot take, v pripravku ali izdelku, ki so pod carinskim nadzorom, če niso bile obdelane ali predelane in če so v začasni hrambi v prosti coni ali prostem skladišču, ker se bodo ponovno izvozile ali ker so v prehodu;
substances, on their own, in a preparation or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;
neizolirane vmesne proizvode.
non-isolated intermediates;
odpadke, kot so opredeljeni v Direktivi Sveta 75/442/EGS
waste, as defined by Council Directive 75/442/EEC
živila, kot so opredeljena v Uredbi (ES) št. 178/2002;
food, as defined by Regulation (EC) No 178/2002;
arome, kot so opredeljene v Direktivi Sveta 88/388/EGS
flavourings, as defined by Council Directive 88/388/EEC
UL L 184, 15.7.1988, str.
OJ L 184, 15.7.1988, p.
snovi v tobačnih proizvodih v okviru Direktive 2001/37/ES Evropskega parlamenta in Sveta
substances in tobacco products within the scope of Directive 2001/37/EC of the European Parliament and of the Council
UL L 194, 18.7.2001, str.
OJ L 194, 18.7.2001, p.
Ta uredba se uporablja brez poseganja v:
This Regulation shall apply without prejudice to:
zakonodajo Skupnosti na področju zdravja in varnosti pri delu
Community legislation on health and safety at the workplace
prepovedi in omejitve, določene v Direktivi Sveta 76/768/EGS z dne 27. julija 1976 o približevanju zakonodaj držav članic v zvezi s kozmetičnimi izdelki
the prohibitions and restrictions laid down in Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products
Direktiva, kakor je bila nazadnje spremenjena z Direktivo Komisije 2005/52/ES (UL L 234, 10.9.2005, str.
Directive as last amended by Commission Directive 2005/52/EC (OJ L 234, 10.9.2005, p.
prepovedjo preskusov na živalih za končne kozmetične proizvode in sestavine ali za kombinacije njihovih sestavin; in
the prohibition of animal testing of finished cosmetic products and the ingredients or combinations of ingredients thereof; and
trženjem kozmetičnih proizvodov, katerih nekatere ali vse sestavine ali končna sestava je bila testirana na živalih.
the marketing of cosmetic products of which some or all of the ingredients, or the final formulation, have been tested on animals.
Če so snovi, ki se uporabljajo le kot kozmetične sestavine, vključene v to uredbo, ni dovoljeno nobeno testiranje na živalih, ki je prepovedano na podlagi Direktive 76/768/EGS, za namene enake ocene, ki jo zahteva ta uredba v zvezi s takšnimi snovmi;
To the extent that substances used only as cosmetic ingredients are covered by this Regulation, no animal testing that is prohibited pursuant to Directive 76/768/EEC shall be permitted for the purposes of the same assessment required by this Regulation with regard to such substances;
okoljsko zakonodajo Skupnosti.
Community legislation on the environment.
Ta uredba velja za vsako snov, izdelek in pripravek, uvožen v Evropsko unijo.
This Regulation shall apply to every substance, article and preparation imported into the European Union.
Ta uredba nikakor ne sme povzročiti različnega obravnavanja snovi, izdelkov in pripravkov, proizvedenih v Evropski uniji, ter snovi, izdelkov in pripravkov, ki so proizvedeni v tretjih državah in uvoženi v Evropsko unijo.
This Regulation may in no way give rise to differences in treatment between substances, articles and preparations produced in the European Union and substances, articles and preparations that are produced in third countries but imported into the European Union.
Komisija določi smernice za zagotovitev, da se to pravilo uporablja.
The Commission shall set out guidelines for ensuring this rule is applied.
Določbe iz naslovov II, III, V in VI ne veljajo za obseg, v katerem se snov proizvaja ali uvaža za uporabo v naslednjih končnih izdelkih, ali za obseg, v katerem se snov v njih uporablja:
The provisions in Titles II, III, V and VI shall not apply to the extent that a substance is manufactured or imported for use in the following end products or to the extent a substance is used in them:
zdravila za ljudi ali v veterini v okviru Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council
, Direktive 2001/82/ES ali Direktive 2001/83/ES;
, Directive 2001/82/EC or Directive 2001/83/EC;
živila, kot so opredeljena v Uredbi (ES) št. 178/2002, vključno z:
food as defined in Regulation (EC) No 178/2002, including:
živilskimi dodatki v živilih na področju uporabe Direktive Sveta 89/107/EGS
food additives in foodstuffs within the scope of Council Directive 89/107/EEC
aromo za živila na področju uporabe Direktive 88/388/EGS;
flavouring in foodstuffs within the scope of Directive 88/388/EEC;
živalska krma, vključno s/z
animal feed, including:
krmnimi dodatki na področju uporabe Uredbe (ES) št. 1831/2003 Evropskega parlamenta in Sveta
additives in feedingstuffs within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council
Uredba, kakor je bila spremenjena z Uredbo Komisije (ES) št. 378/2005 (UL L 59, 5.3.2005, str.
Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p.
UL L 213, 21.7.1982, str.
OJ L 213, 21.7.1982, p.
Direktiva, kakor je bila nazadnje spremenjena z Direktivo Komisije 2004/116/ES (UL L 379, 24.12.2004, str.
Directive as last amended by Commission Directive 2004/116/EC (OJ L 379, 24.12.2004, p.
v materialih za stik z živili na področju uporabe Uredbe (ES) št. 1935/2004 Evropskega parlamenta in Sveta
food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council
UL L 338, 13.11.2004, str.
OJ L 338, 13.11.2004, p.
medicinski pripomočki na področju uporabe Direktive Sveta 90/385/EGS
medical devices within the scope of Council Directive 90/385/EEC
UL L 189, 20.7.1990, str.
OJ L 189, 20.7.1990, p.
, Direktive Sveta 93/42/EGS
, Council Directive 93/42/EEC
UL L 169, 12.7.1993, str.
OJ L 169, 12.7.1993, p.
ali Direktive 98/79/ES Evropskega parlamenta in Sveta
or Directive 98/79/EC of the European Parliament and of the Council
UL L 331, 7.12.1998, str.
OJ L 331, 7.12.1998, p.
fitofarmacevtska sredstva na področju uporabe Direktive Sveta 91/414/EGS
plant protection products within the scope of Council Directive 91/414/EEC
Direktiva, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 396/2005 Evropskega parlamenta in Sveta (UL L 70, 16.3.2005, str.
Directive as last amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council (OJ L 70, 16.3.2005, p.
biocidni proizvodi na področju uporabe Direktive 98/8/ES Evropskega parlamenta in Sveta
biocidal products within the scope of Directive 98/8/EC of the European Parliament and of the Council
Določbe iz Naslova VII se ne uporabljajo za uporabo snovi, določene v odstavku 4 in kot dodatek naslednjim uporabam:
The provisions in Title VII shall not apply to the uses of substances set out in paragraph 4 and in addition to the following uses:
uporabe kot na mestu izolirani vmesni proizvod ali kot pripeljani izolirani vmesni proizvod;
use as on-site isolated intermediates or transported isolated intermediates;
uporaba kot motorno gorivo, zajeta v Direktivi 98/70/ES Evropskega parlamenta in Sveta
use as motor fuels covered by Directive 98/70/EC of the European Parliament and of the Council
uporabe izdelkov iz mineralnih olj kot gorivo za premične ali stacionarne kurilne naprave in uporabo kot gorivo v zaprtih sistemih.
use as fuel in mobile or fixed combustion plants of mineral oil products and use as fuels in closed systems.
Določbe iz naslovov IV in X se ne uporabljajo za pripravke, naštete v točkah (a) do (g) odstavka 4, ali za snovi v teh pripravkih.
The provisions in Titles IV and X shall not apply to preparations listed in points (a) to (g) of paragraph 4 or to substances in those preparations.
OPREDELITVE POJMOV Člen 3 Opredelitve pojmov
DEFINITIONS Article 3 Definitions
Za to uredbo:
For the purposes of this Regulation:
Snov pomeni kemični element in njegove spojine v naravnem stanju ali pridobljene s kakršnim koli proizvodnim postopkom, vključno z vsemi dodatki, potrebnimi za ohranitev njene obstojnosti, in vsemi nečistočami, ki nastanejo pri uporabljenem postopku, ne vključuje pa topil, ki se lahko izločijo, ne da bi to vplivalo na obstojnost snovi ali spremenilo njeno sestavo.
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;
Pripravek pomeni zmes ali raztopino, sestavljeno iz dveh ali več snovi
Preparation means a mixture or solution composed of two or more substances;
Kovinska zlitina pomeni kovinski material, ki je homogen v makroskopskem obsegu in ki je sestavljen iz dveh ali več elementov, združenih tako, da jih ni mogoče zlahka ločiti z mehanskimi postopki.
Metallic alloy means a metallic material, homogeneous on a macroscopic scale, consisting of two or more elements so combined that they cannot readily be separated by mechanical means;
Izdelek pomeni
Article means
je sestavljen iz
composed of
ene ali več snovi in/ali pripravka/(ov)
substance(s) and/or preparation(s)
, ki med proizvodnjo dobi/(jo) posebno obliko ali površino,
which during production is given a specific shape, surface or design
Polimer pomeni snov, sestavljeno iz molekul, za katere je značilno zaporedje ene ali več vrst monomernih enot,
Polymer means a substance consisting of molecules characterised by the sequence of one or more types of monomer units
in obsega navadno masno večino molekul, ki vsebujejo najmanj tri monomerne enote, vezane na najmanj eno drugo monomerno enoto ali drugi reaktant, pri čemer je snov sestavljena iz manj kot navadne masne večine molekul iste molekulske mase
and comprising a simple weight majority of molecules containing at least three monomer units which are bound to at least one other monomer unit or other reactant, with the substance consisting of less than a simple weight majority of molecules of the same molecular weight
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
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
Registracijski zavezanec pomeni proizvajalca ali uvoznika, ki vloži registracijo.
Registrant means the manufacturer or the importer submitting a registration;
Proizvodnja pomeni proizvodnjo in pridobivanje snovi v naravnem stanju.
Manufacturing means production and extraction of substances in the natural state;
Proizvajalec pomeni fizično ali pravno osebo s stalnim bivališčem oziroma sedežem v Skupnosti, ki proizvaja snov v Skupnosti.
Manufacturer means any natural or legal person established within the Community who manufactures a substance within the Community;
Uvoz pomeni fizični vnos na carinsko območje Skupnosti.
Import means the physical introduction into the customs territory of the Community;
Proizvajalec izdelka pomeni fizično ali pravno osebo, ki:
Producer of an article means a natural or legal person who:
proizvaja in prodaja pod lastno blagovno znamko;
manufactures and sells under his own brand;
preprodaja pod lastno blagovno znamko proizvod, pa se ne šteje za proizvajalca, če se na proizvodu pojavi blagovna znamka izdelovalca;
resells under his own brand a product produced by another supplier, a reseller not being regarded as the producer if the brand of the manufacturer appears on the product;
poklicno uvaža na trg Skupnosti.
on a professional basis imports into the Community market;
Uvoznik pomeni fizično ali pravno osebo s stalnim bivališčem oziroma sedežem v Skupnosti, ki je odgovorna za uvoz.
Importer means any natural or legal person established within the Community who is responsible for import;
Dajanje v promet pomeni dobavo ali dajanje izdelkov na voljo tretjim osebam za plačilo ali neodplačno.
Placing on the market means supplying or making available, whether in return for payment or free of charge, to a third party.
Uvoz na carinsko območje Skupnosti se šteje za dajanje v promet.
Import into the customs territory of the Community shall be deemed to be placing on the market;
Uporabnik na nižji stopnji 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.
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.
Distributer ali potrošnik ni uporabnik na nižji stopnji.
A distributor or a consumer is not a downstream user.
Ponovni uvoznik, izvzet v skladu s
A re-importer exempted pursuant to
členom 4(1)(d)
Article 4(1)(d)
, se šteje za uporabnika na nižji stopnji.
shall be regarded as a downstream user;
Uporaba pomeni predelavo, proizvodnjo, porabo, hrambo, posedovanje, obdelavo, polnjenje v posode, prenos iz ene posode v drugo, mešanje, izdelavo izdelka ali katero koli drugo uporabo.
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;
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.
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;
Vmesni proizvod pomeni snov
Intermediate means a substance
ali pripravek
or preparation
, ki se proizvede in porabi ali uporabi izključno pri kemični predelavi za preoblikovanje v drugo snov (v nadaljevanju
that is solely manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter called
neizoliran vmesni proizvod pomeni vmesni proizvod, ki se med sintezo namerno ne odstrani (razen za vzorčenje) iz opreme, v kateri poteka 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.
Takšna oprema vključuje reakcijsko posodo, njeno pomožno opremo in vso opremo, skozi katero gre(do) snov(i) med neprekinjenim ali serijskim postopkom, 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;
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;
na mestu izoliran vmesni proizvod pomeni vmesni proizvod, ki ne izpolnjuje meril za neizolirani vmesni proizvod, pri čemer proizvodnja vmesnega proizvoda in sinteza druge(ih) snovi iz tega vmesnega proizvoda potekata na istem mestu, izvaja pa jo ena ali več pravnih oseb;
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 more legal entities;
prepeljan izoliran vmesni proizvod pomeni vmesni proizvod, ki ne izpolnjuje meril za neizoliran vmesni proizvod in se prepelje v drug kraj oziroma pripelje iz drugega kraja.
transported isolated intermediate means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites;
Mesto pomeni določeno lokacijo, kjer si, če je proizvajalcev snovi več, ti delijo določeno infrastrukturo in naprave.
Site means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared;
Udeleženci dobavne verige pomeni vse proizvajalce in/ali uvoznike ter/ali uporabnike na nižji stopnji.
Actors in the supply chain means all manufacturers and/or importers and/or downstream users;
Obveščanje po dobavni verigi navzdol pomeni, da vsak udeleženec dobavne verige sporoča informacije uporabniku na nižji stopnji, kateremu dobavlja snov.
Communicate down the supply chain means that each actor in the supply chain communicates to the downstream user whom he supplies with a substance;
Obveščanje po dobavni verigi navzgor pomeni, da uporabnik na nižji stopnji sporoča informacije udeležencu dobavne verige, ki mu je dobavil snov.
Communicate up the supply chain means that a downstream user communicates to the actor in the supply chain who has supplied him with a substance;
Pristojni organ pomeni organ ali organe, ki jih ustanovijo države članice za izvajanje obveznosti iz te uredbe.
Competent authority means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation;
Snov v postopnem uvajanju pomeni snov, ki
Phase-in substance means a substance
vsaj eno od naslednjih meril:
at least one of the following criteria:
snov je
it is
našteta v Evropskem seznamu kemičnih snovi, ki so na trgu (EINECS);
listed in the European Inventory of Existing Commercial Chemical Substances (Einecs);
med 18. septembrom 1981 in vključno 31. oktobrom 1993 se je snov proizvajala v Skupnosti ali v državah, ki so k Evropski uniji pristopile 1. maja 2004, ali se je tja uvažala, proizvajalec ali uvoznik jo je dal tudi v promet in je veljala za priglašeno v skladu s prvo alineo člena 8(1) Direktive 67/548/EGS, kakor je bila spremenjena z Direktivo 79/831/EGS UL L 259, 15.10.1979, str.
it was placed on the market in the Community, or in the countries acceding to the European Union on 1 May 2004, and between 18 September 1981 and 31 October 1993 inclusive it was also placed on the market 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, as amended by Directive 79/831/EEC OJ L 259, 15.10.1979, p.
, ne ustreza pa opredelitvi za polimer iz Direktive 67/548/EGS, kakor je bila spremenjena z Direktivo 92/32/EGS UL L 154, 5.6.1992, str.
, but does not meet the definition of a polymer set out in Directive 67/548/EEC, as amended by Directive 92/32/EEC OJ L 154, 5.6.1992, p.
Prijavljena snov pomeni snov, za katero je bila predložena prijava in ki se lahko da v promet v skladu z Direktivo 67/548/EGS.
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;
V proizvode in postopke usmerjene raziskave in razvoj pomeni vsak znanstveni razvoj
Product and process orientated research and development means any scientific development
(skupaj s pripravki in izdelki, uporabljenimi za poskusne teste pod pravimi pogoji)
(including preparations and articles used for pilot tests under real conditions)
, povezan z razvojem proizvoda ali nadaljnjim razvojem snovi
related to product development, the further development of a substance,
kot take, pripravkov ali izdelkov
on its own, in preparations or in articles,
, pri čemer se za razvoj proizvodnega postopka in/ali za preskus področja uporabe snovi uporabijo poskusni proizvodni obrat ali proizvodni preskusi.
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;
Znanstvene raziskave in razvoj pomeni znanstvene preskuse, analize ali kemijske raziskave, ki potekajo pod nadzorovanimi
Scientific research and development means any scientific experimentation, analysis or chemical research carried out under controlled
Lastna uporaba registracijskega zavezanca pomeni uporabo registracijskega zavezanca v industrijske ali poklicne namene.
Registrant's own use means an industrial or professional use by the registrant;
Navedena 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 uporabnik na nižji stopnji in je zajeta v varnostnem listu, poslanemu zadevnemu uporabniku na nižji stopnji.
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 and that is covered in the safety data sheet communicated to the downstream user concerned;
uporaba pomeni uporabo uporabnikov na nižji stopnji, ki jo registracijski zavezanec odsvetuje
use means a use by downstream users which the registrant advises against
Zanesljiv študijski povzetek pomeni podroben povzetek ciljev, metod, rezultatov in sklepov iz popolnega študijskega poročila, ki zagotavlja dovolj informacij za izvedbo neodvisne ocene študije in čim bolj zmanjša potrebo po preverjanju v celotnem študijskem poročilu.
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;
Na leto pomeni na koledarsko leto.
Per year means per calendar year.
Razen če ni v primeru novih snovi
Save in the case of new substances, and
drugače navedeno
unless stated otherwise
Mala in srednje velika podjetja (MSP) so podjetja, kot so opredeljena v Priporočilu 2003/361/ES.
Small and medium-sized enterprises (SMEs) means enterprises as defined in Recommendation 2003/361/EC;
Občutljive skupine prebivalstva so dovzetni ljudje, vključno z novorojenčki, dojenčki, otroki, nosečnicami, doječimi materami, slabotnimi in imunsko oslabelimi, starejšimi osebami, posameznimi genetsko občutljivimi ljudmi in drugimi opredeljenimi zadevnimi skupinami.
Vulnerable populations means susceptible humans including neonates, infants, children, pregnant women, nursing mothers, the infirm and immuno-compromised, elderly persons, those with individual genetic susceptibilities and other identified groups of concern;
Predvideni potek izpostavljenosti pomeni niz pogojev, vključno z ukrepi za obvladovanje tveganja, ki opisujejo, kako se snov proizvaja ali uporablja v življenjskem ciklu in kako proizvajalec in uvoznik nadzirata izpostavljenost ljudi in okolja ali to priporočata uporabnikom na nižji stopnji.
Exposure scenario means the set of conditions including risk management measures that describe how the substance is manufactured or used during its life-cycle and how the manufacturer and importer controls, or recommends to downstream users that they may control, exposures of humans and the environment.
Ti predvideni poteki izpostavljenosti lahko vključujejo en poseben postopek ali uporabo ali več postopkov ali uporab, kot je ustrezno, pri čemer so lahko ti postopki ali uporabe opisani glede na skupine uporab in izpostavljenosti, kot je določeno.
These exposure scenarios may cover one specific process or use or several processes or uses, as appropriate, where these processes or uses may be described in terms of use and exposure categories, as defined;