natgillin/translations-raw huggingface dataset:
This should ensure a clear and effective implementation with proportionate costs, guaranteeing a high level of protection of human health and the environment without adversely affecting innovation and competitiveness.
To bi moralo zagotoviti jasno in učinkovito izvajanje s sorazmernimi stroški, da se zagotovi visoka raven varovanja zdravja ljudi in varstva okolja, ter preprečiti negativne vplive na inovacije in konkurenčnost.
The adopted changes for nanoforms should be without prejudice to the performance and documentation of risk assessment of other forms of the registered substance, unless it has implicitly included nanoforms in the assessment.
Sprejete spremembe za nanooblike ne bi smele vplivati na izvajanje in dokumentiranje ocene tveganja za druge oblike registrirane snovi, razen če so v njeni oceni implicitno vključene nanooblike.
Manufacturers and importers should assess and where relevant, generate the necessary information and document in the chemical safety report that the risks, arising from the identified uses of the substance with nanoforms they manufacture or import, are adequately controlled.
Proizvajalci in uvozniki bi morali oceniti in, kjer je to ustrezno, pridobiti potrebne informacije ter v poročilu o kemijski varnosti navesti, da so tveganja, ki izhajajo iz opredeljenih uporab snovi z nanooblikami, ki jo proizvajajo ali uvažajo, ustrezno nadzorovana.
To ensure clarity, the chemical safety report should describe whether and which different nanoforms are covered by the assessment and how the information is compiled in the report.
Za zagotovitev jasnosti bi moralo biti v poročilu o kemijski varnosti opisano, ali in katere različne nanooblike so zajete v oceni ter kako so informacije zbrane v poročilu.
A use may modify the nanoforms of the substance, potentially changing one nanoform into another form or generating a new nanoform.
Nanooblike snovi se lahko z uporabo spremenijo, pri čemer se lahko ena nanooblika spremeni v drugo obliko ali se ustvari nova nanooblika.
Downstream users should provide this information up the supply chain to ensure that the use is adequately covered by the registration dossier of the manufacturer or importer, or alternatively cover the specific use in their own chemical safety report.
Nadaljnji uporabniki bi morali te informacije posredovati po dobavni verigi navzgor za zagotovitev, da se uporaba ustrezno zajame v registracijski dokumentaciji proizvajalca ali uvoznika, ali pa posebno uporabo zajeti v svojem poročilu o kemijski varnosti.
As the majority of nanomaterials are expected to be nanoforms of phase-in substances, the conditions for the requirements for generation of new toxicological and ecotoxicological information on phase-in low volume substances should be elaborated to ensure that the assessment criteria are based also on the predicted properties of nanoforms.
Ker se za večino nanomaterialov pričakuje, da bodo nanooblike snovi v postopnem uvajanju, bi bilo treba oblikovati pogoje za zahteve za pridobitev novih toksikoloških in ekotoksikoloških informacij o snoveh v postopnem uvajanju v manjših količinah za zagotovitev, da merila ocenjevanja temeljijo tudi na predvidenih lastnostih nanooblik.
The existing qualitative or quantitative structure-activity relationship (QSAR) and other tools do not yet enable prioritisation; therefore, the insolubility information should be applied as a surrogate for potential toxicological and ecotoxicological aspects for the nanoforms of a substance.
Obstoječe kvalitativno in kvantitativno razmerje med strukturo in aktivnostjo (QSAR) ter druga orodja še ne omogočajo prioritizacije, zato bi bilo treba informacije o netopnosti uporabiti kot nadomestek za morebitne toksikološke in ekotoksikološke vidike nanooblik snovi.
For nanoforms, specific minimum characterisation information should be provided as part of the composition information under the substance identification.
Posebne minimalne informacije za opredelitev nanooblik bi bilo treba zagotoviti kot del informacij o sestavi v okviru identifikacije snovi.
Particle size, shape and surface properties of a nanoform may influence its toxicological or ecotoxicological profile, exposure as well as behaviour in the environment.
Velikost in oblika delcev ter površinske lastnosti nanooblike lahko vplivajo na njen toksikološki in ekotoksikološki profil, izpostavljenost in obnašanje v okolju.
For reasons of workability and proportionality, it should be possible to group nanoforms with similar characteristics in sets of similar nanoforms.
Zaradi izvedljivosti in sorazmernosti bi moralo biti mogoče nanooblike s podobnimi lastnostmi združiti v skupine podobnih nanooblik.
The characterisers of the different nanoforms within sets of similar nanoforms should be provided in ranges of values that clearly define the boundaries of the set of similar nanoforms.
Opredelitvene lastnosti različnih nanooblik znotraj skupin podobnih nanooblik bi bilo v treba zagotoviti v razponih vrednosti, ki jasno opredeljujejo meje skupine podobnih nanooblik.
When set of similar nanoform is defined, a justification should be provided that a variation within these boundaries does not affect the hazard assessment, exposure assessment and risk assessment of the individual nanoforms within the set of similar nanoforms.
Ko se opredeljuje skupina podobnih nanooblik, bi bilo treba dokazati, da odstopanja znotraj teh meja ne vplivajo na oceno nevarnosti, oceno izpostavljenosti ali oceno tveganja posameznih nanooblik iz skupine podobnih nanooblik.
All different nanoforms covered by the registration should be considered by the registrant in the demonstration of safety.
Registracijski zavezanec bi moral pri dokazovanju varnosti upoštevati vse različne nanooblike, ki jih zajema registracija.
Similarly, the information on manufacture, uses of and exposure to the different nanoforms should be provided separately to demonstrate their safe use.
Prav tako bi bilo treba ločeno zagotoviti informacije o proizvodnji in uporabi različnih nanooblik ter izpostavljenosti slednjim, da se dokaže njihova varna uporaba.
Where defined, a set of similar nanoforms may be used to document this information jointly for the nanoforms within the set.
Kjer je opredeljena skupina podobnih nanooblik, se lahko ta uporabi za skupno dokumentiranje teh informacij za nanooblike iz skupine.
Nanoforms or sets of nanoforms, where defined, should be identified in the joint submission using the same nanoform characterisation principles and should provide the link between the nanoforms identified in the individual registrations and the relevant information in the joint submission.
Kadar so opredeljene nanooblike ali skupine nanooblik, bi bilo treba v skupni predložitvi identificirati z uporabo istih načel za opredelitev nanooblik ter zagotoviti povezavo med nanooblikami, identificiranimi v posameznih registracijah, in ustreznimi informacijami v skupni predložitvi.
To allow for adequate assessment of the relevance of any physicochemical, toxicological and ecotoxicological information for the different nanoforms, the test material should be appropriately characterised.
Da se omogoči ustrezna ocena primernosti kakršnih koli fizikalno-kemijskih, toksikoloških in ekotoksikoloških informacij za različne nanooblike, bi bilo treba ustrezno opredeliti testni material.
For the same reasons, test conditions documented and a scientific justification for the relevance and adequacy of the utilised test material as well as documentation for the relevance and adequacy of the information obtained from means other than testing for the different nanoforms should be provided.
Iz istih razlogov bi bilo treba za različne nanooblike ali skupine nanooblik zagotoviti dokumentirane pogoje testiranja ter znanstveno utemeljitev primernosti in ustreznosti uporabljenega testnega materiala, kot tudi dokumentirati primernost in ustreznost informacij, pridobljenih drugače kot s testiranjem.
The rate of dissolution in water as well as in relevant biological and environmental media should always be considered for nanoforms as it represents important complementary information to water solubility as a basic physico-chemical property of nanoforms that may determine the approach to their risk assessment and testing.
Pri nanooblikah bi bilo vedno treba obravnavati hitrost raztapljanja v vodi ter ustreznih bioloških in okoljskih medijih, saj slednja predstavlja pomembno dopolnilno informacijo k vodotopnosti kot temeljni fizikalno-kemijski lastnosti nanooblik, ki lahko določa pristop k oceni tveganja in testiranju.
The partition coefficient in octanol-water is generally used as a proxy for adsorption or accumulation but may often not be applicable to nanoforms.
Kot posredni kazalnik adsorpcije ali kopičenja se običajno uporablja porazdelitveni koeficient n-oktanol/voda, vendar slednji pogosto ni uporaben za nanooblike.
In those cases, the study of dispersion stability in the different relevant test media that significantly influences these endpoints as well as any estimations of exposure to nanoforms, should be considered instead.
V takšnih primerih bi ga bilo treba nadomestiti s preučevanjem disperzijske stabilnosti v različnih ustreznih testnih medijih, ki bistveno vpliva na te končne točke in na morebitne ocene izpostavljenosti nanooblikam.
Certain physico-chemical properties such as water solubility or partition coefficient in octanol-water serve as input to well established QSARs and other predictive models that can be used for adaptations of some of the information requirements.
Nekatere fizikalno-kemijske lastnosti, kot sta topnost v vodi ali porazdelitveni koeficient n-oktanol/voda, se uporabijo kot vhodni podatki za dobro uveljavljene modele QSAR in druge napovedovalne modele, ki se lahko uporabijo za prilagoditev nekaterih zahtev po informacijah.
As the underlying assumptions may not always apply to nanomaterials, such adaptations should be used for nanoforms only with scientific justification.
Ker osnovne predpostavke morda ne bodo vedno veljale za nanomateriale, bi bilo treba take prilagoditve za nanooblike uporabljati le z znanstveno utemeljitvijo.
In specific cases, the dissolution rate in the relevant test media may be used instead.
V posebnih primerih se lahko alternativno uporabi hitrost raztapljanja v ustreznem testnem mediju.
To allow efficient assessment of the potential exposure for inhalable nanoforms, in particular in workplaces, information on dustiness should be provided for the different nanoforms.
Da se omogoči učinkovita ocena morebitne izpostavljenosti za nanooblike, ki jih je mogoče vdihniti, zlasti na delovnih mestih, bi bilo treba zagotoviti informacije o prašenju za različne nanooblike.
The specific properties of the nanoform may sometimes prevent their uptake through the cell wall of bacteria, rendering the in vitro gene mutation study in bacteria (the AMES test B.13-14, OECD TG 471) inappropriate.
Posebne lastnosti nanooblike lahko včasih preprečujejo njihovo absorpcijo prek celične stene bakterij, zaradi česar je študija genske mutacije in vitro pri bakterijah (Amesov test B.13–14, OECD TG 471) neustrezna.
To ensure that the tiered strategy for mutagenicity can still be implemented also in such cases, one or more other in vitro mutagenicity study(ies) in mammalian cells or other internationally recognised in vitro methods should be provided in such cases also for low-volume substances.
Za zagotovitev, da se lahko tudi v takih primerih še vedno izvaja stopenjska strategija za mutagenost, bi bilo treba v takih primerih tudi za snovi v majhnih količinah zagotoviti eno ali več drugih študij mutagenosti in vitro v celicah sesalcev ali druge mednarodno priznane metode in vitro.
Although acute toxicity testing for the lowest tonnage is required via the oral route, for nanoforms, inhalation is considered as more appropriate route of exposure and should be required instead, unless the exposure to humans is unlikely.
Čeprav se za najnižjo raven tonaže zahteva testiranje akutne strupenosti pri zaužitju, se lahko za nanooblike za ustreznejši način izpostavljenosti šteje vdihavanje in bi bilo treba zahtevati takšno testiranje, razen, če izpostavljenost ljudi ni verjetna.
For the generation of information on short term repeated dose and sub-chronic toxicity via inhalation route, testing of a nanoform should always include histopathological determination of brain, lung tissues as well as examination of bronchoalveolar lavage (BAL) fluid, kinetics and an appropriate recovery period, in line with the OECD technical guidance.
Za pridobitev informacij o kratkodobni strupenosti pri ponovljenih odmerkih ali subkronični strupenosti pri vdihavanju bi moralo testiranje nanooblike vedno vključevati histopatološko preiskavo možganskih in pljučnih tkiv ter pregled bronhoalveolarnega izpirka (BAL), kinetike in ustreznega obdobja okrevanja v skladu s tehničnimi smernicami OECD..
Unless the nanoform dissolves fast once entering the organism, the distribution of a nanoform in the body may affect the toxicological profile when compared to other forms of the same substance.
Porazdelitev nanooblike v telesu lahko vpliva na toksikološki profil, kadar se primerja z drugimi oblikami iste snovi, razen če se nanooblika po vstopu v telo hitro raztopi.
Therefore, an assessment of the toxicokinetic behaviour should be available for the chemicals safety assessment of a nanoform, when such assessment is required.
Zato bi morala biti za oceno kemijske varnosti nanooblike, kadar je ta potrebna, na voljo ocena toksikokinetičnega vedenja.
This should allow the development of effective testing strategy or its adaptation for the substance with nanoforms with the aim of minimising animal testing.
To bi moralo omogočiti razvoj učinkovite strategije testiranja ali njeno prilagoditev za snov z nanooblikami, da se čim bolj zmanjša testiranje na živalih.
Where relevant, a study complementing the compilation of existing toxicokinetic information should be proposed by the registrant or may be requested by the European Chemicals Agency (the Agency) in accordance with Article 40 or 41 of the Regulation (EC) No 1907/2006.
Kadar je ustrezno, bi moral registracijski zavezanec predlagati študijo za dopolnitev zbirke obstoječih informacij o toksikokinetiki ali pa jo lahko zahteva Evropska agencija za kemikalije (v nadaljnjem besedilu: Agencija) v skladu s členom 40 ali 41 Uredbe (ES) št. 1907/2006.
A number of specific physico-chemical properties in addition to those used to identify the different nanoforms may be considered relevant for scientific understanding of the hazard and exposure of a nanomaterial, with the necessary parameters depending on the individual case.
Za znanstveno razumevanje nevarnosti nanomateriala in izpostavljenosti slednjemu se lahko za ustrezne štejejo številne posebne fizikalno-kemijske lastnosti poleg tistih, ki se uporabljajo za identifikacijo različnih nanooblik, pri čemer so potrebni parametri odvisni od posameznega primera.
For reasons of workability and proportionality, only registrants for substances (including any nanoforms) that are placed on the market in higher volumes than 10 tonnes/year should be required to explicitly consider such further information in case other particle properties significantly influence hazard or exposure to those nanoforms.
Zaradi učinkovitosti in sorazmernosti bi bilo treba zahtevati, naj izrecno upoštevajo take dodatne informacije, če druge lastnosti delcev bistveno vplivajo na nevarnost ali izpostavljenost navedenim nanooblikam, samo od registracijskih zavezancev za snovi (vključno z morebitnimi nanooblikami), ki se dajejo na trg v količinah, večjih od 10 ton/leto.
The adaptation of the standard testing requirements in Annexes VII to X to Regulation (EC) No 1907/2006 applying general rules for adaptation under Section 1 of Annex XI should address different nanoforms separately.
Pri prilagoditvi standardnih zahtev glede testiranja v prilogah od VII do X Uredbe (ES) št. 1907/2006 na podlagi splošnih pravil za prilagoditev iz oddelka 1 Priloge XI bi bilo treba različne nanooblike obravnavati ločeno.
For grouping of different nanoforms, the molecular structural similarity alone cannot serve as justification for the application of read-across or grouping.
Za združevanje različnih nanooblik v skupine se kot utemeljitev za uporabo navzkrižnega branja ali združevanja v skupine ne more uporabiti zgolj podobnost molekulske strukture.
The Agency, in cooperation with Member States and stakeholders, should further develop guidance documents for the application of the test methods and waiving possibilities for the standard information requirements provided by this Regulation for the purposes of Regulation (EC) No 1907/2006.
Agencija bi morala v sodelovanju z državami članicami in deležniki še naprej razvijati operativne smernice za uporabo testnih metod in možnosti za opustitev zahtev po standardnih informacijah iz te uredbe za namene Uredbe (ES) št. 1907/2006.
Annexes I, III and VI to XII to Regulation (EC) No 1907/2006 should therefore be amended accordingly.
Priloge I, III in od VI do XII k Uredbi (ES) št. 1907/2006 bi bilo zato treba ustrezno spremeniti.
Compliance with the provisions of this Regulation should not be required immediately in order to allow all registrants and downstream users adequate time to adapt to the more specific requirements for substances with nanoforms.
Skladnost z določbami te uredbe se ne bi smela zahtevati takoj, da se tako vsem registracijskim zavezancem in nadaljnjim uporabnikom omogoči dovolj časa za prilagoditev bolj specifičnim zahtevam za snovi z nanooblikami.
However, it should be possible for registrants to comply with those provisions already before the date of application.
Vendar bi bilo treba registracijskim zavezancem omogočiti, da navedene določbe upoštevajo že pred datumom začetka uporabe.
Annexes I, III and VI to XII to Regulation (EC) No 1907/2006 are amended in accordance with the Annex to this Regulation.
Priloge I, III in od VI do XII k Uredbi (ES) št. 1907/2006 se spremenijo v skladu s Prilogo k tej uredbi.
By way of derogation from the second paragraph of Article 3, manufacturers and importers registering substances with nanoforms either as non-phase-in or phase-in substances pursuant to Article 5 of Regulation (EC) No 1907/2006 as well as downstream users generating chemical safety reports may comply with this Regulation before 1 January 2020.
Z odstopanjem od drugega odstavka člena 3 lahko proizvajalci in uvozniki, ki snovi z nanooblikami registrirajo kot snovi, ki niso v postopnem uvajanju, ali kot snovi v postopnem uvajanju v skladu s členom 5 Uredbe (ES) št. 1907/2006, ter nadaljnji uporabniki, ki pripravljajo poročila o kemijski varnosti, to uredbo upoštevajo že pred 1. januarjem 2020.
It shall apply from 1 January 2020.
Uporablja se od 1. januarja 2020.
Impact assessment on Possible amendments of Annexes to REACH for registration of nanomaterials [SWD(2018)474].
Ocena učinka o morebitnih spremembah prilog k uredbi REACH za registracijo nanomaterialov (SWD(2018) 474).
Annex I to Regulation (EC) No 1907/2006 is amended as follows:
Priloga I k Uredbi (ES) št. 1907/2006 se spremeni:
Subsection 0.1. is replaced by the following:
pododdelek 0.1 se nadomesti z naslednjim:
The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use(s) and that others further down the supply chain can adequately control the risks.
Namen te priloge je prikazati, kako morajo proizvajalci in uvozniki oceniti in dokumentirati, da so tveganja, izhajajoča iz snovi, ki jih proizvajajo ali uvažajo, med proizvodnjo in njihovimi uporabami teh snovi pod ustreznim nadzorom in da so drugi subjekti v dobavni verigi sposobni ustrezno obvladovati tveganja.
The chemical safety report shall also describe whether and which different nanoforms of substances as characterised in Annex VI are manufactured and imported, including an adequate justification for each information requirement describing when and how information on one form is used to demonstrate safety of other forms.
V poročilu o kemijski varnosti je tudi opisano, ali in katere različne nanooblike snovi, kot so opredeljene v Prilogi VI, se proizvajajo in uvažajo, vključno z ustrezno utemeljitvijo za vsako zahtevo po informacijah, v kateri je opisano, kdaj in kako se informacije o eni obliki uporabijo za dokazovanje varnosti drugih oblik.
The requirements speof the following hazard classes or categories setcific to nanoforms of a substance in this Annex apply to all nanoforms covered by the registration and without prejudice to requirements applicable to other forms of that substance.
Zahteve v tej prilogi, ki so specifične za nanooblike snovi, se uporabljajo za vse nanooblike, ki so zajete v registraciji, brez poseganja v zahteve, ki veljajo za druge oblike navedene snovi.
This Annex shall also apply adapted as necessary to producers and importers of articles required to make a chemical safety assessment as part of a registration.’;
Ta priloga se, ustrezno prilagojena, uporablja tudi za izdelovalce in uvoznike izdelkov, ki morajo kot del registracije opraviti oceno kemijske varnosti.“;
Subsection 0.3. is replaced by the following:
pododdelek 0.3 se nadomesti z naslednjim:
The chemical safety assessment of a manufacturer shall address the manufacture of a substance and all the identified uses.
V oceni kemijske varnosti proizvajalca se obravnavajo proizvodnja snovi in vse opredeljene uporabe.
The chemical safety assessment of an importer shall address all identified uses.
V oceni kemijske varnosti uvoznika se obravnavajo vse opredeljene uporabe.
The chemical safety assessment shall consider the use of the substance on its own (including any major impurities and additives), in a mixture and in an article, as defined by the identified uses.
Ocena kemijske varnosti preuči uporabo snovi kot take (vključno z vsemi pomembnejšimi nečistotami in dodatki), v zmesi in izdelku, kakor je določeno z opredeljenimi uporabami.
The assessment shall address all nanoforms that are covered by the registration.
V oceni se obravnavajo vse nanooblike, ki so zajete v registraciji.
The justifications and conclusions drawn from the assessment shall be relevant to these nanoforms.
Utemeljitve in sklepi, izpeljani iz ocene, so upoštevni za te nanooblike.
The chemical safety assessment shall be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance taking into account implemented and recommended risk management measures and operational conditions.’;
Ocena kemijske varnosti temelji na primerjavi potencialno škodljivih učinkov snovi z znano oziroma razumno predvidljivo izpostavljenostjo ljudi in/ali okolja tej snovi, ob upoštevanju izvedenih in priporočenih ukrepov za obvladovanje tveganja ter delovnih pogojev.“;
Subsection 0.4. is replaced by the following:
pododdelek 0.4 se nadomesti z naslednjim:
Substances whose physicochemical, toxicological and eco-toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or “category” of substances.
Snovi, katerih fizikalno-kemijske, toksikološke ali ekotoksikološke lastnosti so lahko podobne ali sledijo urejenemu vzorcu kot rezultat strukturne podobnosti, se lahko upoštevajo kot skupina ali ‚kategorija‘ snovi.
If the manufacturer or importer considers that the chemical safety assessment carried out for one substance is sufficient to assess and document that the risks arising from another substance or from a group or “category” of substances are adequately controlled then he can use that chemical safety assessment for the other substance or group or “category” of substances.
Če po mnenju proizvajalca ali uvoznika ocena kemijske varnosti neke snovi zadostuje za oceno in dokumentiranje ustreznega nadzora tveganj, ki izhajajo iz druge snovi ali skupine ali ‚kategorije‘ snovi, lahko uporabi to oceno kemijske varnosti za druge snovi ali skupino ali ‚kategorijo‘ snovi.