natgillin/translations-raw huggingface dataset:
(b) epidemiološke podatke in izkušnje o učinkih na ljudi o sami zmesi ali o snoveh, ki jih vsebuje;
(b) epidemiological data and experience on the effects on humans for the mixture itself or the substances contained in it;
(b) zanesljive epidemiološke podatke in znanstveno preverjene izkušnje o učinkih na ljudi o sami zmesi ali o snoveh, ki jih vsebuje (npr. podatke o poklicni izpostavljenosti, zbirke podatkov o nesrečah in morebitne študije) ;
(b) reliable epidemiological data and scientifically valid experience on the effects on humans for the mixture itself or the substances contained in it (e.g. occupational data, data from accident databases and from prospective studies) ;
(c) katere koli druge informacije, pridobljene v skladu z oddelkom 1 Priloge XI k Uredbi (ES) št. 1907/2006 o sami zmesi ali o snoveh, ki jih vsebuje .
(c) any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006 for the mixture itself or the substances contained in it.
(c) katere koli druge informacije, pridobljene v skladu z oddelkom 1 Priloge XI k Uredbi (ES) št. 1907/2006 o sami zmesi ali o snoveh, ki jih vsebuje ;
(c) any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006 for the mixture itself or the substances contained in it;
(ca) katerekoli druge informacije, pridobljene preko mednarodnih programov za ravnanje s kemikalijami o sami zmesi ali o snoveh, ki jih vsebuje;
(ca) any other information generated under international chemical programmes for the mixture itself or the substances contained in it;
(cb) informacije o sestavi in razvrstitvi obstoječih zmesi znotraj skupine podobnih zmesi.
(cb) information regarding the composition and classification of existing mixtures within a group of similarly related mixtures.
Informacije se nanašajo na obliko ali agregatno stanje, v katerem se zmes uporablja ali se lahko upravičeno pričakuje, da se bo uporabljala, potem ko bo dana na trg.
The information shall relate to the form or physical state in which the mixture is used or can reasonably be expected to be used after it is placed on the market.
Informacije se nanašajo, kadar je to pomembno, na obliko ali agregatno stanje, v katerem se zmes uporablja ali se lahko upravičeno pričakuje, da se bo uporabljala, potem ko bo dana na trg.
The information shall relate , when relevant , to the form or physical state in which the mixture is used or can reasonably be expected to be used after it is placed on the market.
Člen 6 – odstavek 2
Article 6 - paragraph 2
Ob upoštevanju odstavkov 3 in 4, kadar so informacije iz odstavka 1(a) na voljo za samo zmes in se je dobavitelj prepričal, da so te informacije ustrezne in zanesljive, dobavitelj te informacije uporabi za oceno v skladu s poglavjem 2.
Subject to paragraphs 3 and 4, where the information referred to in paragraph 1(a) is available for the mixture itself, and the supplier has ascertained that information to be adequate and reliable, he shall use that information for the purposes of the evaluation pursuant to Chapter 2.
Ob upoštevanju odstavkov 3 in 4, kadar so informacije iz odstavka 1 na voljo za samo zmes in se je dobavitelj prepričal, da so te informacije ustrezne in zanesljive, dobavitelj te informacije uporabi za oceno v skladu s poglavjem 2.
Subject to paragraphs 3 and 4, where the information referred to in paragraph 1 is available for the mixture itself, and the supplier has ascertained that information to be adequate and reliable, he shall use that information for the purposes of the evaluation pursuant to Chapter 2.
Omeniti bi bilo treba odstavek 1 kot celoto, da se vključijo vsi razpoložljivi podatki s tem v zvezi.
The reference should be to paragraph 1 as a whole, so as to include all available relevant data.
Člen 6 – odstavek 5
Article 6 - paragraph 5
Kadar ni na voljo nikakršnih podatkov iz odstavka 1 o sami zmesi, dobavitelj uporabi druge dostopne informacije o posameznih snoveh in podobnih preskušenih zmeseh , ki se lahko štejejo kot bistvene pri ugotavljanju, ali je zmes nevarna, vendar le, če se je prepričal, da so te informacije ustrezne in zanesljive, da se uporabijo za oceno v skladu s členom 9(4).
Where no test data on the mixture itself of the kind referred to in paragraph 1 are available, the supplier shall use other available information on individual substances and similar tested mixtures which may also be considered relevant for the purposes of determining whether the mixture is hazardous, provided that he has ascertained that information to be adequate and reliable for the purpose of the evaluation pursuant to Article 9(4).
Kadar ni na voljo nikakršnih podatkov iz odstavka 1 o sami zmesi, dobavitelj uporabi vse dostopne vse informacije, ki so na voljo o posameznih snoveh in zmeseh ali zmeseh znotraj skupine podobnih zmesi , ki se lahko štejejo kot bistvene pri ugotavljanju, ali je zmes nevarna, vendar le, če se je prepričal, da so te informacije ustrezne in zanesljive, da se uporabijo za oceno v skladu s členom 9(4).
Where no data on the mixture itself of the kind referred to in paragraph 1 are available, the supplier shall use all available information on individual substances and mixtures or mixtures within a group of similarly related mixtures which may also be considered relevant for the purposes of determining whether the mixture is hazardous, provided that he has ascertained that information to be adequate and reliable for the purpose of the evaluation pursuant to Article 9(4).
Za izvajanje strokovnih zaključkov in oceno sklepov, doseženih z dokazi, ki so predvideni v Prilogi I, delu I, oddelku 1.1.1., je nujno, da se zberejo podatki, ki so na voljo o zmeseh znotraj skupine podobnih zmesi.
For the application of expert judgement and weight of evidence determinations, foreseen in Annex I Part I, Section 1.1.1., it is necessary to collate available data on mixtures within any groups of similarly related mixtures.
Vsi podatki iz odstavka 1 niso testni podatki (v običajnem pomenu besede), npr. tisti iz odstavka 1(b), zato bi bilo treba nanašanje na testne podatke črtati.
Not all of the data referred to in paragraph 1 are ‘test’ data (in the conventional sense), e.g. that in paragraph 1 (b), and consequently reference to ‘test’ data should be deleted.
Člen 7 – odstavek 1
Article 7 - paragraph 1
Kadar se izvajajo novi preskusi za namen te uredbe, se preskusi na živalih v smislu Direktive 86/609/EGS izvedejo samo tedaj, ko ni na voljo nobene druge možnosti.
Where new tests are carried out for the purposes of this Regulation, tests on animals within the meaning of Directive 86/609/EEC shall be undertaken only where no other alternatives are possible.
Kadar se izvajajo novi preskusi za namen te uredbe, se preskusi na živalih v smislu Direktive 86/609/EGS izvedejo samo tedaj, ko ni na voljo nobene druge možnosti, ki bi zagotovila enako zanesljive in kakovostne podatke .
Where new tests are carried out for the purposes of this Regulation, tests on animals within the meaning of Directive 86/609/EEC shall be undertaken only where no other alternatives , which provide the same level of reliability and quality of data, are possible.
Testne metode se redno preverjajo in izboljšujejo za zmanjšanje števila poskusov na vretenčarjih in števila vključenih živali.
Testing methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved.
Poudariti je potrebno zavezanost zmanjšanju števila poskusov na živalih.
It is necessary to reiterate here the commitment to reduce animal testing.
Člen 7 – odstavek 2
Article 7 - paragraph 2
Preskusi na ljudeh ali drugih primatih za namene te uredbe se ne izvajajo.
Tests on humans and non-human primates shall not be performed for the purpose s of this Regulation.
Testi na ljudeh samo za namene te uredbe na splošno niso sprejemljivi in se lahko izvajajo samo, ko ni nobenih alternativ, ki bi zagotovile najboljše varovanje zdravja ljudi in razvrščanje snovi ali zmesi v skladu z njihovimi dejanskimi učinki na zdravje ljudi .
Tests on humans for the sole purpose of this Regulation are generally not acceptable and shall only be undertaken when no other alternatives are possible to ensure the best protection of human health and the classification of a substance or mixture according to its actual effects on human health.
Testi na drugih primatih za namene te uredbe se ne izvajajo.
Tests on non-human primates shall not be performed for the purposes of this Regulation.
Preskusi na drugih primatih za namene te uredbe se ne bi smeli izvajati.
Tests on non-human primates should not be allowed for the purposes of this regulation.
Člen 7 – odstavek 2 a (novo)
Article 7 - paragraph 2 a (new)
Študije validacije, ki ocenjujejo teste, ki ne vključujejo živali, ali metode, ki zmanjšujejo število uporabljenih živalih ali njihovo trpljenje, se pripravijo, da bi se zagotovilo, da bodo nove metode testiranja upoštevale zahteve iz te uredbe in podobne zakonodaje, ki izvaja globalno usklajeni sistem za razvrščanje in označevanje kemikalij v drugih pristojnih organih tako, da razvrščanje in označevanje ne postaneta oviri za zamenjavo, zmanjšanje ali izboljšanje testiranja na živalih.
Validation studies to assess non-animal tests, or methods that reduce the number of animals used or the suffering experienced by test animals, shall be designed to ensure that new test methods take account of the requirements contained in this Regulation and similar legislation implementing the Globally Harmonised System of Classification and Labelling of Chemicals in other jurisdictions so that classification and labelling requirements do not become a barrier to the replacement, reduction and refinement of animal testing.
To lahko zavira začetek uporabe alternativnih metod in podaljša uporabo testiranja na živalih v primerih, ko obstajajo znanstveno veljavne alternativne metode.
This can delay the uptake of new alternative methods, and prolong the use of animal tests even when scientifically valid alternative methods exist.
Člen 7 – odstavek 2 b (novo)
Article 7 - paragraph 2 b (new)
Ob zadostnih znanstvenih zagotovilih in da bi zmanjšali testiranje na živalih, Komisija sprejme to uredbo v skladu z regulativnim postopkom s pregledom iz člena 54(3), da bi zagotovila, da zahteve razvrščanja in označevanja ne postanejo ovira pri uporabi testnih metod, ki zamenjajo, zmanjšajo ali izboljšajo testiranje na živalih.
Where there is sufficient scientific justification, and in order to minimise animal testing, the Commission shall adapt this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 54(3) to ensure that classification and labelling requirements do not become a barrier to the use of test methods that replace, reduce or refine animal testing.
Kljub temu, da se GHS običajno obravnava kot nevtralna testna metoda, je možno, da lahko alternativne metode preizkušanja (z uporabo zamenjave, zmanjšanja ali z izboljšanjem razmer za uporabljene živali) prispevajo podatke, ki se ne ujemajo neposredno s trenutnimi merili razvrščanja, ki se velikokrat nanašajo na pojave pri poskusih in vivo, ali neposredno na učinke na poskusnih živalih.
Although the GHS is often referred to as ‘test method neutral’, it is possible that alternative test methods (applying the principle of replacement, reduction and refinement of animal use) may provide data that do not directly correspond to current classification criteria, many of which reference in vivo phenomena or refer directly to effects in ‘tested animals’.
Zato bi moralo biti mogoče merila za razvrščanje in označevanje prilagoditi, da bi lahko sprejeli metode, ki po svoji naravi ne vključujejo testov na živalih.
It should therefore be possible to adapt classification and labelling criteria to accommodate methods which, by their very nature, do not involve testing on animals.
Člen 8 – odstavek 3 – točka (c)
Article 8 - paragraph 3 - point (c)
(c) za nevarnosti za zdravje in okolje, kakor so določene v delih 3 in 4 Priloge I, mednarodno priznana znanstvena načela ali metode, potrjene v skladu z mednarodnimi postopki.
(c) in respect of health and environmental hazards as set out in parts 3 and 4 of Annex I, internationally recognised scientific principles or methods validated according to international procedures.
(c) za nevarnosti za zdravje in okolje, kakor so določene v delih 3 in 4 Priloge I, upoštevajoč tehtna, po možnosti mednarodno priznana znanstvena načela ali metode, potrjene v skladu z mednarodnimi postopki.
(c) in respect of health and environmental hazards as set out in parts 3 and 4 of Annex I, complying with sound scientific principles, preferably internationally recognised, or methods validated according to international procedures.
Da bi ugotovili, kakšne so nevarnosti za zdravje in okolje, se je treba sklicevati na tehtna, mednarodno priznana znanstvena načela.
For the purpose of identifying health and environmental hazards, a reference needs to be made to sound scientific principles that are internationally recognised.
Člen 8 – odstavek 4
Article 8 - paragraph 4
Preskusi, ki se izvajajo za namen te uredbe, se izvedejo na snovi ali zmesi v obliki, v kateri se uporablja ali za katero se lahko upravičeno pričakuje, da se bo uporabljala, ko bo dana v promet.
Tests that are carried out for the purposes of this Regulation, shall be carried out on the substance or on the mixture in the form in which it is used or reasonably can be expected to be used after it is placed on the market.
Preskusi, ki se izvajajo za namen te uredbe, se izvedejo na snovi ali zmesi v obliki, v kateri je bilo predvideno, da se uporablja ali v obliki/fizičnem stanju, v katerem bo dana v promet.
Tests that are carried out for the purposes of this Regulation shall be carried out on the substance or on the mixture in the form in which it is intended to be used , or in the form and/or physical state as placed on the market.
Skladnost z besedilom GHS 1.3.3.1.1 (b) – ocena temelji na zadevnem izdelku.
Consistency with text of GHS 1.3.3.1.1 (b) "the evaluation is based on the actual product involved".
Člen 9 – odstavek 4 – pododstavek 2
Article 9 - paragraph 4 - subparagraph 2
Kadar pa te informacije ne omogočajo uporabe premostitvenih načel, dobavitelj oceni informacije z uporabo druge metode ali metod, opisanih v posameznih oddelkih iz delov 3 in 4 Priloge I.
However, where that information does not permit the application of the bridging principles, the supplier shall evaluate the information by applying the other method or methods described in each section of parts 3 and 4 of Annex I.
Kadar pa te informacije ne omogočajo uporabe premostitvenih načel in ko mnenje izvedencev ne more opravičiti širitve prek premostitvenih načel , dobavitelj oceni informacije z uporabo druge metode ali metod, opisanih v posameznih oddelkih iz delov 3 in 4 Priloge I.
However, where that information does not permit the application of the bridging principles, and expert judgement cannot justify extensions beyond the bridging principles, the supplier shall evaluate the information by applying the other method or methods described in each section of parts 3 and 4 of Annex I.
Zaradi skladnosti z uporabo izraza ZN – GHS o mnenju izvedencev (1.3.2.4.8 Vijolične knjige): „Pristop k razvrščanju zmesi predvideva na mnogih področjih pomoč izvedencev, da bi se zagotovilo, da so obstoječe informacije uporabne za čim večje število zmesi, da bi se tako varovalo človekovo zdravje in okolje.“
For consistency with the UN GHS wording on expert judgement (1.3.2.4.8 of the Purple Book): “The approach to classifying mixtures includes the application of expert judgement in a number of areas in order to ensure existing information can be used for as many mixtures as possible to provide protection for human health and the environment”.
Člen 9 – odstavek 4 a (novo)
Article 9 - paragraph 4 a (new)
Pri ocenjevanju podatkov proizvajalec ali uvoznik upošteva dodatne informacije, kot je oblika in/ali fizično stanje, v katerem se snov ali zmes uporablja po tem, ko je dana v promet in lahko temu primerno izboljša razvrščanje.
When evaluating the data the manufacturer or importer shall consider additional information such as the form and/or physical state in which the substance or mixture is used after it is placed on the market and may refine the classification accordingly.
Pri razvrščanju snovi ali zmesi je treba upoštevati običajno ravnanje in uporabo.
Normal handling and use should be taken into consideration in the classification of a substance or mixture.
Skladnost s trenutno ravnijo varnosti, da bi se obdržalo načelo običajne obravnave in uporabe, kot nujni preostanek obstoječe zakonodaje EU, kot je na primer razred snovi, nevarnih za ozonski plašč.
Consistency with the current level of protection to retain the principle of normal handling and use as a necessary 'left over' from existing EU legislation like for example the class 'hazardous to the ozone layer.
Člen 9 – odstavek 4 b (novo)
Article 9 - paragraph 4b (new)
Kadar je za specifičen proizvodni sektor vzpostavljen center za nevarnost in razvrstitev, ki združuje strokovno znanje pri oceni informacij, podatke o testiranjih, določanje zanesljivosti dokazov in premostitvena načela glede snovi in zmesi v tej skupini proizvodov, se dobavitelj pri ugotavljanju nevarnosti, povezanih s to snovjo ali zmesjo, lahko zanese na oceno, ki jo pripravi center.
Where a specific product sector group has established a Hazard and Classification Centre, which brings together expertise in the evaluation of information, test data, weight of evidence determinations, and bridging principles, any supplier within the product sector may rely on an evaluation from that centre for the establishment of the hazards associated with, and the corresponding classification of, the mixture.
Kadar ima proizvajalec glede snovi, uporabljenih v izdelku (zmesi), na voljo le informacijo, ki mu jo zagotovi(jo) dobavitelj(i), se pri določitvi razvrstitve snovi opira na oceno informacij, izvedeno po postopku iz člena 9(4).
Where the manufacturer only has the information provided by the supplier(s) of the substances used in the product (mixture), he will rely on an evaluation of information under the procedure given in Article 9 paragraph 4 to establish the classification of the mixture.
Pri tem lahko pride do podcenjevanja ali (še raje) do precenjevanja nevarnih lastnosti zmesi.
This may under- or (particularly) over-estimate the hazardous properties of the mixture.
Dostopnost in priznanje postopka, ki bi omogočal pridobitev presoje strokovnjakov ter dodatnih informacij in podatkov, potrebnih za oceno zmesi, bosta zagotovila natančnejše razvrščanje in koristila predvsem malim in srednje velikim podjetjem.
The availability and recognition of a procedure whereby expertise, additional information and data can be made available to evaluate a mixture will ensure a more accurate classification and be of particular value to SMEs.
Člen 10 – odstavek 1
Article 10 - paragraph 1
Ob upoštevanju odstavka 3 lahko dobavitelj v naslednjih primerih določi posebne mejne koncentracije kot pragove, pri katerih ali nad katerimi prisotnost zadevne snovi v drugi snovi ali zmesi kot nečistoče, dodatka ali posamezne sestavine povzroči razvrstitev snovi ali zmesi kot nevarne:
Subject to paragraph 3, specific concentration limits whereby a threshold is indicated on or over which the presence of that substance in another substance or in a mixture as an impurity, additive or individual constituent may lead to the classification of the substance or mixture as hazardous may be set by the supplier in the following situations:
Ob upoštevanju odstavka 3 lahko dobavitelj v naslednjih primerih določi posebne mejne koncentracije kot pragove, pri katerih ali nad katerimi prisotnost zadevne snovi v drugi snovi ali zmesi kot znane nečistoče, dodatka ali posamezne sestavine povzroči razvrstitev snovi ali zmesi kot nevarne:
Subject to paragraph 3, specific concentration limits whereby a threshold is indicated on or over which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent may lead to the classification of the substance or mixture as hazardous may be set by the supplier in the following situations:
(a) kadar informacije kažejo, da je snov očitno nevarna že, ko je prisotna v koncentraciji, nižji od koncentracij, določenih za posamezen razred nevarnosti v delu 2 Priloge I, ali nižji od splošnih mejnih koncentracij, določenih za posamezen razred nevarnosti v delih 3 do 5 Priloge I;
(a) where information shows that the hazard of a substance is evident when it is present at a level below the concentrations set for any hazard class in part 2 of Annex I or below the generic concentration limits set for any hazard class in parts 3 to 5 of Annex I;
(b) izjemoma tudi v primerih , ko informacije kažejo, da je snov, ki je razvrščena kot nevarna, prisotna v koncentraciji, višji od koncentracij, določenih za posamezen razred nevarnosti v delu 2 Priloge I, ali višji od splošnih mejnih koncentracij, določenih za posamezen razred nevarnosti v delih 3 do 5 navedene priloge, vendar prepričljivi podatki kažejo, da snov očitno ni nevarna.
(b) in exceptional cases , where information shows that a substance classified as hazardous is present at a level above the concentrations set for any hazard class in part 2 of Annex I or above the generic concentration limits set for any hazard class in parts 3 to 5 of that Annex, but there are conclusive data showing that the hazard of the substance is not evident.
(b) v primeru , ko informacije kažejo, da je snov, ki je razvrščena kot nevarna, prisotna v koncentraciji, višji od koncentracij, določenih za posamezen razred nevarnosti v delu 2 Priloge I, ali višji od splošnih mejnih koncentracij, določenih za posamezen razred nevarnosti v delih 3 do 5 navedene priloge, vendar prepričljivi podatki kažejo, da snov očitno ni nevarna.
(b) on occasion , where information shows that a substance classified as hazardous is present at a level above the concentrations set for any hazard class in part 2 of Annex I or above the generic concentration limits set for any hazard class in parts 3 to 5 of that Annex, but there are conclusive data showing that the hazard of the substance is not evident.
(i) ugotovljena nečistoča – izvedljivost, zlasti za kompleksne snovi, in skladno s cilji trenutne zakonodaje; (ii) v primeru – skladno z besedilom GHS 1.3.3.2.3
(i) "identified impurity" - Workability, particularly for complex substances, and consistency with the scope of the current legislation; (ii) "on occasion" - in line with GHS text 1.3.3.2.3
Člen 10 – odstavek 6 a (novo)
Article 10 - paragraph 6 a (new)
Dobavitelj določi meje koncentracije skladno z merili iz smernic agencije, in vključi obrazložitev, v skladu s popisom razvrstitev in označitev, v svoje obvestilo ali, v skladu z Uredbo (ES) št. 1907/2006, v svojo prijavo.
The supplier shall set concentration limits in accordance with the criteria set out in the guidance made available by the Agency, and shall include the justification therefor either in his notification according to the classification and labelling inventory or in his registration according to Regulation (EC) No 1907/2006.
V skladu z dobaviteljem SCL in poročanju o faktorjih m, kot je bilo prvotno predlagano v spletni različici Priloge I, dela I, 1.1.4.3 in v besedilu GHS 1.3.3.2.4.
In line with supplier SCL and m-factor reporting as originally proposed for Internet version Annex I, Part 1, 1.1.4.3 and GHS text 1.3.3.2.4..
Člen 11 – odstavek 1
Article 11 - paragraph 1
Kadar snov vsebuje drugo snov, ki je sama razvrščena kot nevarna, v obliki nečistoče, dodatka ali posamezne sestavine, se ta informacija upošteva pri razvrščanju, če je koncentracija nečistoče, dodatka ali posamezne sestavine enaka ali večja od mejne vrednosti iz odstavka 3.
Where a substance contains another substance, classified as hazardous itself, in the form of an impurity, additive or individual constituent, this information shall be taken into account for the purposes of classification, if the concentration of the impurity, additive or individual constituent is equal to or greater than its cut-off value referred to in paragraph 3.