natgillin/translations-raw huggingface dataset:
In order to prevent unnecessary animal testing, interested parties should have a period of 45 days during which they may provide scientifically valid information and studies that address the relevant substance and hazard end-point, which is addressed by the testing proposal.
Za preprečitev nepotrebnega testiranja na živalih bi morale zainteresirane strani imeti 45-dnevno obdobje, v katerem lahko predložijo znanstveno veljavne informacije in študije, ki obravnavajo zadevno snov in končno točko nevarnosti, kar obravnava predlog za test.
The scientifically valid information and studies received by the Agency should be taken into account for decisions on testing proposals.
Pri odločanju o predlogih za teste bi bilo treba upoštevati znanstveno veljavne informacije in študije, ki jih prejme Agencija.
In addition, it is necessary to instil confidence in the general quality of registrations and to ensure that the public at large as well as all stakeholders in the chemicals industry have confidence that natural or legal persons are meeting the obligations placed upon them.
Treba je tudi vzpostaviti zaupanje v splošno kakovost registracij ter zagotoviti, da javnost in vse interesne skupine v kemijski industriji zaupajo, da fizične in pravne osebe izpolnjujejo predpisane obveznosti.
Accordingly, it is appropriate to provide for recording which information has been reviewed by an assessor possessing appropriate experience, and for a percentage of registrations to be checked for compliance by the Agency.
V skladu s tem je primerno, da se zagotovi evidenco o tem, katere informacije je pregledal ocenjevalec z ustreznimi izkušnjami ter kakšen je odstotek registracij, ki jih Agencija preverja glede skladnosti.
The Agency should also be empowered to require further information from manufacturers, importers or downstream users on substances suspected of posing a risk to human health or the environment, including by reason of their presence on the internal market in high volumes, on the basis of evaluations performed.
Agencijo bi bilo treba tudi pooblastiti, da od proizvajalcev, uvoznikov ali nadaljnjih uporabnikov na podlagi izvedenih evalvacij zahteva dodatne informacije o snoveh, za katere sumi, da pomenijo nevarnost za zdravje ljudi ali okolje, vključno z utemeljitvijo, zakaj so na notranjem trgu v velikih količinah.
Based on the criteria for prioritising substances developed by the Agency in cooperation with the Member States a Community rolling action plan for substance evaluation should be established, relying on Member State competent authorities to evaluate substances included therein.
Na podlagi kriterijev za določitev prednostnega seznama snovi, ki ga v sodelovanju z državami članicami pripravi Agencija, bi bilo treba pripraviti tekoči akcijski načrt Skupnosti za evalvacijo snovi, pri čemer bi se zanesli na pristojne organe države članice, da evalvirajo snovi, ki so v njem vključene.
If a risk equivalent to the level of concern arising from the use of substances subject to authorisation arises from the use of isolated intermediates on site, the competent authorities of the Member States should also be allowed to require further information, when justified.
Če je nevarnost, ki izhaja iz uporabe izoliranih intermediatov na kraju samem, enakovredna nevarnosti, ki izhaja iz uporabe snovi, za katere je treba pridobiti avtorizacijo, bi bilo treba tudi pristojnim organom držav članic omogočiti, da lahko zahtevajo dodatne informacije, kadar je to upravičeno.
Collective agreement within the Agency's Member State Committee on its draft decisions should provide the basis for an efficient system that respects the principle of subsidiarity, while maintaining the internal market.
Skupni dogovor Odbora držav članic v okviru Agencije o osnutkih odločitev bi moral zagotavljati podlago učinkovitega sistema, ki upošteva načelo subsidiarnosti, hkrati pa ohranja notranji trg.
If one or more Member States or the Agency do not agree to a draft decision, it should be adopted subject to a centralised procedure.
Če se ena ali več držav članic ali Agencija z osnutkom odločitve ne strinjajo, bi jo bilo treba sprejeti v skladu s centraliziranim postopkom.
If the Member State Committee fails to reach unanimous agreement, the Commission should adopt a decision in accordance with a Committee procedure.
Če Odbor držav članic soglasja ne doseže, bi morala Komisija sprejeti odločitev v skladu s postopkom komitologije.
Evaluation may lead to the conclusion that action should be taken under the restriction or authorisation procedures or that risk management action should be considered in the framework of other appropriate legislation.
Evalvacija lahko pripelje do zaključka, da bi bilo treba sprejeti ukrepe v okviru omejevalnega postopka ali postopka avtorizacije ali da bi bilo treba preučiti ukrepe za obvladovanje tveganja v okviru druge ustrezne zakonodaje.
Information on the progress of evaluation proceedings should therefore be made public.
Zato bi morale biti informacije o poteku postopkov evalvacije objavljene.
To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention.
Da se zagotovi dovolj visoka raven varovanja zdravja ljudi, vključno ob upoštevanju ustreznih skupin populacije in morebiti določenih občutljivih podpopulacij, in varstva okolja, je treba snovem, ki zbujajo veliko skrb, v skladu z načelom previdnosti nameniti posebno pozornost.
Authorisation should be granted where natural or legal persons applying for an authorisation demonstrate to the granting authority that the risks to human health and the environment arising from the use of the substance are adequately controlled.
Avtorizacijo bi bilo treba dodeliti, če fizične ali pravne osebe, ki zaprosijo za avtorizacijo, organom za dodelitev avtorizacije dokažejo, da so tveganja za zdravje ljudi ali okolje, ki izhajajo iz uporabe snovi, ustrezno nadzorovana.
Otherwise, uses may still be authorised if it can be shown that the socio-economic benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable.
Uporabo se lahko vseeno odobri, če se dokaže, da socialno-ekonomske koristi zaradi uporabe snovi prevladajo nad tveganjem, povezanim z njihovo uporabo, in da ni na voljo ustreznih alternativnih snovi ali tehnologij, ki so ekonomsko in tehnično izvedljive.
Taking into account the good functioning of the internal market it is appropriate that the Commission should be the granting authority.
Ob upoštevanju dobrega delovanja notranjega trga je primerno, da bi bil organ za dodelitev avtorizacije Komisija.
Adverse effects on human health and the environment from substances of very high concern should be prevented through the application of appropriate risk management measures to ensure that any risks from the uses of a substance are adequately controlled, and with a view to progressively substituting these substances with a suitable safer substance.
Škodljive učinke skrb vzbujajočih snovi na zdravje ljudi in okolje bi bilo treba preprečevati z izvajanjem ustreznih ukrepov za obvladovanje tveganja, da se zagotovi ustrezen nadzor nad kakršnim koli tveganjem pri uporabi snovi in se te snovi postopoma nadomesti z varnejšimi.
Risk management measures should be applied to ensure, when substances are manufactured, placed on the market and used, that exposure to these substances including discharges, emissions and losses, throughout the whole life-cycle is below the threshold level beyond which adverse effects may occur.
Uporabiti bi bilo treba ukrepe za obvladovanje tveganja, da se pri proizvodnji, dajanju na trg in uporabi snovi zagotovi, da je izpostavljenost tem snovem, vključno z izpusti, emisijami in izgubami, v celotnem življenjskem ciklu pod mejno vrednostjo, nad katero se lahko pojavijo škodljivi učinki.
For any substance for which authorisation has been granted, and for any other substance for which it is not possible to establish a safe level of exposure, measures should always be taken to minimise, as far as technically and practically possible, exposure and emissions with a view to minimising the likelihood of adverse effects.
Za vsako snov, ki ji je bila dodeljena avtorizacija, in katero koli drugo snov, za katero ni mogoče določiti varne stopnje izpostavljenosti, bi bilo treba vedno sprejeti ukrepe za zmanjšanje izpostavljenosti in emisij, kolikor je to tehnično in praktično izvedljivo, da se kar se da zmanjša verjetnost škodljivih učinkov.
Measures to ensure adequate control should be identified in any Chemical Safety Report.
V vsakem poročilu o kemijski varnosti bi bilo treba določiti ukrepe za zagotavljanje ustreznega nadzora.
These measures should be applied and, where appropriate, recommended to other actors down the supply chain.
Te ukrepe bi bilo treba izvajati in po potrebi priporočati drugim udeležencem na nižji stopnji dobavne verige.
Methodologies to establish thresholds for carcinogenic and mutagenic substances may be developed taking into account the outcomes of RIPs.
Metodologije za določanje pragov za rakotvorne in mutagene snovi se lahko oblikujejo ob upoštevanju rezultatov RIP.
The relevant Annex may be amended on the basis of these methodologies to allow thresholds where appropriate to be used while ensuring a high level of protection of human health and the environment.
Ustrezna priloga se lahko spremeni na podlagi teh metodologij, s čimer se po potrebi omogoči uporaba pragov, hkrati pa zagotavlja visoka raven varovanja zdravja ljudi in okolja.
To support the aim of eventual replacement of substances of very high concern by suitable alternative substances or technologies, all applicants for authorisation should provide an analysis of alternatives considering their risks and the technical and economic feasibility of substitution, including information on any research and development the applicant is undertaking or intends to undertake.
Vsi vlagatelji za avtorizacijo bi morali zagotoviti analizo drugih možnosti glede tveganj in tehnično ter ekonomsko izvedljivost zamenjave, da bi podprli cilj končne zamenjave snovi, ki zbujajo veliko skrb, z ustreznimi alternativnimi snovmi ali tehnologijami, vključno s podatki o raziskavah in razvoju, ki jih izvaja ali ima namen izvesti vlagatelj.
Furthermore, authorisations should be subject to time-limited review whose periods would be determined on a case-by-case basis and normally be subject to conditions, including monitoring.
Hkrati bi morale biti avtorizacije predmet časovno omejenih pregledov, katerih trajanje bi se določilo na podlagi posameznega primera in pod določenimi pogoji, vključno z monitoringom.
Substitution of a substance on its own, in a preparation or in an article should be required when manufacture, use or placing on the market of that substance causes an unacceptable risk to human health or to the environment, taking into account the availability of suitable safer alternative substances and technologies, and the socio-economic benefits from the uses of the substance posing an unacceptable risk.
Zamenjavo snovi kot take, v pripravku ali izdelku bi bilo treba zahtevati, če proizvodnja snovi, njena uporaba ali dajanje snovi na trg pomeni nesprejemljivo tveganje za zdravje ljudi ali okolje, pri čemer se upošteva razpoložljivost primernih varnejših alternativnih snovi in tehnologij ter socialno-ekonomske koristi uporabe snovi, ki pomeni nesprejemljivo tveganje.
Substitution of a substance of very high concern by suitable safer alternative substances or technologies should be considered by all those applying for authorisations of uses of such substances on their own, in preparations or for incorporation of substances into articles by making an analysis of alternatives, the risks involved in using any alternative and the technical and economic feasibility of substitution.
Zamenjavo skrb vzbujajoče snovi s primernimi bolj varnimi alternativnimi snovmi ali tehnologijami bi morali preučiti vsi, ki prosijo za avtorizacijo uporabe teh snovi kot takih, v pripravkih ali v izdelkih, tako da izvedejo analizo alternativ, tveganj pri uporabi alternativnih snovi ter tehnične in ekonomske izvedljivosti nadomestitve.
The possibility of introducing restrictions on the manufacturing, placing on the market and use of dangerous substances, preparations and articles applies to all substances falling within the scope of this Regulation, with minor exemptions.
Možnost uvedbe omejitev proizvodnje, dajanja na trg in uporabe nevarnih snovi, pripravkov ali izdelkov velja z nekaterimi izjemami za vse snovi, ki sodijo na področje uporabe te uredbe.
Restrictions on the placing on the market and the use of substances which are carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, for their use by consumers on their own or in preparations should continue to be introduced.
Še naprej bi morale veljati omejitve dajanja na trg in uporabe snovi iz skupine 1 ali 2, ki so rakotvorne, mutagene ali strupene za razmnoževanje, kot takih ali v pripravkih s strani potrošnikov.
Experience at international level shows that substances with characteristics rendering them persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, present a very high concern, while criteria have been developed allowing the identification of such substances.
Izkušnje na mednarodni ravni kažejo, da snovi, ki so po svojih lastnostih obstojne, strupene in se lahko kopičijo v organizmih ali so zelo obstojne in se zelo lahko kopičijo v organizmih, zbujajo veliko skrb, zato so bili razviti kriteriji, ki omogočajo prepoznavanje takšnih snovi.
For certain other substances concerns are sufficiently high to address them in the same way on a case-by-case basis.
Nekatere druge snovi zbujajo dovolj veliko skrb, da se obravnavajo enako po posameznih primerih.
The criteria in Annex XIII should be reviewed taking into account the current and any new experience in the identification of these substances and if appropriate, be amended with a view to ensuring a high level of protection for human health and the environment.
Kriterije iz Priloge XIII bi bilo treba pregledati ob upoštevanju sedanjih in vseh novih izkušenj z določitvijo teh snovi ter bi jih bilo treba po potrebi spremeniti, da se zagotovi visoka raven varovanja zdravja ljudi in okolja.
In view of workability and practicality considerations, both as regards natural or legal persons, who have to prepare application files and take appropriate risk management measures, and as regards the authorities, who have to process authorisation applications, only a limited number of substances should be subjected to the authorisation procedure at the same time and realistic deadlines should be set for applications, while allowing certain uses to be exempted.
Glede na pomisleke o izvedljivosti in uporabnosti tako za fizične ali pravne osebe, ki morajo pripraviti dokumentacijo za vlogo in sprejeti ustrezne ukrepe za obvladovanje tveganja, kot za organe, ki morajo obravnavati vloge za avtorizacijo, bi bilo treba zagotoviti, da teče postopek za avtorizacijo hkrati samo za omejeno število snovi, določiti stvarne roke za vloge, hkrati pa omogočiti, da se nekatere uporabe izvzamejo.
Substances identified as meeting the criteria for authorisation should be included in a candidate list for eventual inclusion in the authorisation procedure.
Snovi, ki izpolnjujejo kriterije za avtorizacijo, bi bilo treba vključiti na seznam tistih snovi, ki bodo morda vključene v postopek avtorizacije.
Within this list, substances on the Agency's work programme should be clearly identified.
V okviru seznama je treba snovi na delovnem programu Agencije jasno opredeliti.
The Agency should provide advice on the prioritisation of substances to be made subject to the authorisation procedure, to ensure that decisions reflect the needs of society as well as scientific knowledge and developments.
Agencija bi morala svetovati, za katere snovi je treba najprej uporabiti postopek avtorizacije, da se zagotovi, da odločitve izražajo potrebe družbe ter znanstvena spoznanja in razvoj.
A total ban on a substance would mean that none of its uses could be authorised.
Popolna prepoved snovi pomeni, da se nobena njena uporaba ne sme odobriti.
It would therefore be pointless to allow the submission of applications for authorisation.
Zato bi bilo nesmiselno dovoliti predložitev vlog za avtorizacijo.
In such cases the substance should be removed from the list of substances for which applications can be submitted and added to the list of restricted substances.
V takšnih primerih je treba snov umakniti s seznama snovi, za katere se lahko vložijo vloge za avtorizacijo, in jo dodati na seznam omejenih snovi.
The proper interaction between the provisions on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safety and the environment.
Zagotoviti bi bilo treba ustrezno sovpadanje med določbami o avtorizaciji in določbami o omejevanju, da se ohrani učinkovito delovanje notranjega trga in varovanje zdravja ljudi, varnosti in okolja.
Restrictions that exist when the substance in question is added to the list of substances for which applications for authorisation can be submitted, should be maintained for that substance.
Omejitve, ki obstajajo, ko se zadevno snov doda na seznam snovi, za katere se lahko vložijo vloge za avtorizacijo, bi bilo treba za to snov ohraniti.
The Agency should consider whether the risk from substances in articles is adequately controlled and, if it is not, prepare a dossier in relation to introduction of further restrictions for substances for which the use requires authorisation.
Agencija bi morala preučiti, ali se tveganje, ki izhaja iz snovi v izdelkih, ustrezno nadzoruje, in – če se ne – pripraviti dokumentacijo v zvezi z uvedbo nadaljnjih omejitev za snovi, za uporabo katerih je potrebna avtorizacija.
In order to provide a harmonised approach to the authorisation of the uses of particular substances, the Agency should issue opinions on the risks arising from those uses, including whether or not the substance is adequately controlled and on any socio-economic analysis submitted to it by third parties.
Da se zagotovi usklajen pristop k avtorizaciji za uporabe določenih snovi, bi morala Agencija izdati mnenja o nevarnostih, ki izhajajo iz teh uporab, vključno s presojo ustreznega nadzora snovi, in vsaki socialno-ekonomski analizi, ki ji jo predložijo tretje strani.
These opinions should be taken into account by the Commission when considering whether or not to grant an authorisation.
Takšna mnenja bi morala upoštevati Komisija, ko presoja morebitno avtorizacijo.
To allow effective monitoring and enforcement of the authorisation requirement, downstream users benefiting from an authorisation granted to their supplier should inform the Agency of their use of the substance.
Da se omogoči učinkovito spremljanje in izvajanje zahtev za avtorizacijo, bi morali nadaljnji uporabniki, ki imajo koristi od avtorizacije, izdanih njihovim dobaviteljem, Agencijo obvestiti o svoji uporabi snovi.
It is suitable in these circumstances that final decisions granting or refusing authorisations be adopted by the Commission pursuant to a regulatory procedure in order to allow for an examination of their wider implications within the Member States and to associate the latter more closely with the decisions.
Primerno je, da Komisija sprejema dokončne odločitve o izdaji avtorizacije ali njeni zavrnitvi po regulativnem postopku, ki omogoča preučitev njihovih daljnosežnejših posledic v državah članicah in večjo vključenost slednjih v odločitve.
In order to accelerate the current system the restriction procedure should be restructured and Directive 76/769/EEC, which has been substantially amended and adapted several times, should be replaced.
Da se pospeši sedanji sistem, bi bilo treba postopek omejevanja preoblikovati, Direktivo 76/769/EGS, ki je bila večkrat bistveno spremenjena in prilagojena, pa nadomestiti.
In the interests of clarity and as a starting point for this new accelerated restriction procedure, all the restrictions developed under that Directive should be incorporated into this Regulation.
Zaradi jasnosti in kot izhodišče za novi pospešeni postopek omejevanja bi bilo treba vse omejitve, določene na podlagi navedene direktive, vključiti v to uredbo.
Where appropriate, the application of Annex XVII of this Regulation should be facilitated by guidance developed by the Commission.
Kadar je to primerno, bi bilo treba uporabo Priloge XVII te uredbe olajšati s smernicami, ki jih izdela Komisija.
In relation to Annex XVII Member States should be allowed to maintain for a transitional period more stringent restrictions, provided that these restrictions have been notified according to the Treaty.
Glede na Prilogo XVII bi moralo biti državam članicam za prehodno obdobje dovoljeno ohraniti strožje omejitve, pod pogojem, da so bile te omejitve priglašene v skladu s Pogodbo.
This should concern substances on their own, substances in preparations and substances in articles, the manufacturing, the placing on the market and the use of which is restricted.
To bi moralo veljati za snovi kot take ter snovi v pripravkih in snovi v izdelkih, katerih proizvodnja, dajanje v promet in uporaba je omejena.
The Commission should compile and publish an inventory of these restrictions.
Komisija bi morala zbrati in objaviti popis teh omejitev.
This would provide an opportunity for the Commission to review the measures concerned with a view to possible harmonisation.
To bi bila priložnost za Komisijo, da pregleda zadevne ukrepe zaradi morebitne uskladitve.
It should be the responsibility of the manufacturer, importer and downstream user to identify the appropriate risk management measures needed to ensure a high level of protection for human health and the environment from the manufacturing, placing on the market or use of a substance on its own, in a preparation or in an article.
Proizvajalec, uvoznik in nadaljnji uporabnik bi morali biti odgovorni, da za zagotovitev visoke ravni varovanja zdravja ljudi in okolja opredelijo ustrezne ukrepe za obvladovanje tveganja, ki izhaja iz proizvodnje, dajanja v promet ali uporabe snovi kot take, v pripravkih ali izdelkih.
However, where this is considered to be insufficient and where Community legislation is justified, appropriate restrictions should be laid down.
Če se meni, da to ni dovolj, in če to upravičuje zakonodaja Skupnosti, bi bilo treba določiti ustrezne omejitve.
In order to protect human health and the environment, restrictions on the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article may include any condition for, or prohibition of, the manufacture, placing on the market or use.
Da se zavaruje zdravje ljudi in okolje, lahko omejitve proizvodnje, dajanja v promet ali uporabe snovi kot take, v pripravku ali izdelku vključujejo pogoje za proizvodnjo, dajanje v promet ali uporabo ali prepoved tega.
Therefore it is necessary to list such restrictions and any amendments thereto.
Zato je treba sestaviti seznam takšnih omejitev in vseh njihovih sprememb.
In order to prepare a restrictions proposal and in order for such legislation to operate effectively, there should be good cooperation, coordination and information between the Member States, the Agency, other bodies of the Community, the Commission and the interested parties.
Za pripravo predloga omejitev in učinkovito uporabo takšne zakonodaje bi moralo obstajati dobro medsebojno sodelovanje, usklajevanje in obveščanje med državami članicami, Agencijo, drugimi organi Skupnosti, Komisijo in zainteresiranimi stranmi.