natgillin/translations-raw huggingface dataset:
The Member States, the Agency and all interested parties should take full account of the results of the RIPs, in particular with regard to the registration of substances which occur in nature.
Države članice, Agencija in vse zainteresirane strani bi morale v celoti upoštevati rezultate RIP, zlasti z ozirom na registracijo snovi, ki se nahajajo v naravi.
It is necessary to consider the application of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical processes and the review of Annexes IV and V should fully take this into account.
Treba je preučiti uporabo člena 2(7)(a) in (b) ter Priloge XI glede snovi, pridobljenih z mineraloškimi procesi, in pregled prilog II in III bi moral to v celoti upoštevati.
If tests are performed, they should comply with the relevant requirements of protection of laboratory animals, set out in Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes [11], and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances [12].
Če se izvajajo testi, bi morali biti v skladu z ustreznimi zahtevami za varstvo laboratorijskih živali iz Direktive Sveta 86/609/EGS z dne 24. novembra 1986 o približevanju zakonov in drugih predpisov držav članic o varstvu živali, ki se uporabljajo za poskusne in druge znanstvene namene [11], ter v primeru ekotoksikoloških in toksikoloških testov dobro laboratorijsko prakso iz Direktive 2004/10/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004 o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri testih kemijskih snovi [12].
The generation of information by alternative means offering equivalence to prescribed tests and test methods should also be allowed, for example when this information comes from valid qualitative or quantitative structure activity models or from structurally related substances.
Dovoliti bi bilo treba pridobivanje informacij tudi na druge načine, enakovredne predpisanim testom in testnim metodam, na primer z uporabo validiranih kvalitativnih in kvantitativnih modelov razmerja med strukturo in aktivnostjo ali strukturno sorodnih snovi.
To this end the Agency, in cooperation with Member States and interested parties, should develop appropriate guidance.
V ta namen bi morala Agencija v sodelovanju z državami članicami in zainteresiranimi stranmi pripraviti ustrezna navodila.
It should also be possible not to submit certain information if appropriate justification can be provided.
Treba bi bilo tudi omogočiti, da določenih informacij ni treba predložiti, če se lahko zagotovi ustrezna utemeljitev.
Based on experience gained through RIPs, criteria should be developed defining what constitutes such justification.
Na podlagi izkušenj, pridobljenih z RIP, bi bilo treba razviti kriterije, ki bi določali, kaj šteje kot utemeljitev.
In order to help companies, and in particular SMEs, to comply with the requirements of this Regulation, Member States, in addition to the operational guidance documents provided by the Agency, should establish national helpdesks.
Da pomagajo družbam in še zlasti MSP pri izpolnjevanju zahtev te uredbe, bi morale države članice poleg operativnih navodil, ki jih zagotovi Agencija, vzpostaviti nacionalne službe za pomoč uporabnikom.
The Commission, Member States, industry and other stakeholders should continue to contribute to the promotion of alternative test methods on an international and national level including computer supported methodologies, in vitro methodologies, as appropriate, those based on toxicogenomics, and other relevant methodologies.
Komisija, države članice, industrija in druge interesne skupine bi morale še naprej na mednarodni in nacionalni ravni prispevati k spodbujanju alternativnih testnih metod, vključno z računalniško podprtimi metodologijami, ustreznimi metodologijami in vitro, metodologijami na osnovi toksikogenomike in drugimi ustreznimi metodologijami.
The Community's strategy to promote alternative test methods is a priority and the Commission should ensure that within its future Research Framework Programmes and initiatives such as the Community Action Plan on the Protection and Welfare of Animals 2006 to 2010 this remains a priority topic.
Strategija Skupnosti za spodbujanje alternativnih testnih metod je prednostno področje in Komisija bi morala zagotoviti, da se tudi v prihodnjih okvirnih programih za raziskave ter pobudah, kot je akcijski načrt Skupnosti za zaščito in dobro počutje živali 2006–2010, ohrani kot prednostno področje.
Participation of stakeholders and initiatives involving all interested parties should be sought.
Prizadevati bi si bilo treba za udeležbo interesnih skupin in pobude, ki bodo vključevale vse zainteresirane strani.
For reasons of workability and because of their special nature, specific registration requirements should be laid down for intermediates.
Za intermediate bi bilo treba zaradi izvedljivosti in njihove posebne narave določiti posebne registracijske zahteve.
Polymers should be exempted from registration and evaluation until those that need to be registered due to the risks posed to human health or the environment can be selected in a practicable and cost-efficient way on the basis of sound technical and valid scientific criteria.
Polimere bi bilo treba izvzeti iz registracije in evalvacije, dokler tistih, ki jih je treba registrirati zaradi nevarnosti, ki jo predstavljajo za zdravje ljudi ali okolje, ne bo mogoče določiti na primeren in stroškovno uspešen način na podlagi primernih tehničnih in veljavnih znanstvenih kriterijev.
To avoid overloading authorities and natural or legal persons with the work arising from the registration of phase-in substances already on the internal market, that registration should be spread over an appropriate period of time, without introducing undue delay.
Da se prepreči prevelika obremenitev organov in fizičnih ali pravnih oseb z delom, povezanim z registracijo snovi v postopnem uvajanju, ki so že na notranjem trgu, bi bilo treba to registracijo razporediti v ustreznem časovnem obdobju, brez povzročanja nepotrebnih zamud.
Deadlines for the registration of these substances should therefore be set.
Zato bi bilo treba določiti roke za registracijo teh snovi.
Data for substances already notified in accordance with Directive 67/548/EEC should be eased into the system and should be upgraded when the next tonnage quantity threshold is reached.
Podatke o snoveh, ki so že prijavljene v skladu z Direktivo 67/548/EGS, bi bilo treba prevzeti v sistem in razširiti, ko se doseže naslednji količinski prag.
In order to provide a harmonised, simple system, all registrations should be submitted to the Agency.
Da se zagotovi usklajen in enostaven sistem, bi bilo treba vse registracije predložiti Agenciji.
To ensure a consistent approach and efficient use of resources, it should perform a completeness check on all registrations and take responsibility for any final rejections of registrations.
Da se zagotovi dosleden pristop in učinkovita uporaba virov, bi morala Agencija opraviti pregled popolnosti za vse registracije in prevzeti odgovornost za vse dokončne zavrnitve registracij.
The European Inventory of Existing Commercial Chemical Substances (EINECS) included certain complex substances in a single entry.
V Evropskem seznamu kemičnih snovi, ki so na trgu (EINECS), so bile nekatere kompleksne snovi zajete v enem samem vpisu.
UVCB substances (substances of unknown or variable composition, complex reaction products or biological materials) may be registered as a single substance under this Regulation, despite their variable composition, provided that the hazardous properties do not differ significantly and warrant the same classification.
Snovi UVCB (snovi z neznano ali spremenljivo sestavo, kompleksni reakcijski produkti ali biološki materiali) se lahko po tej uredbi registrirajo kot ena snov kljub njihovi spremenljivi sestavi, če se nevarne lastnosti znatno ne razlikujejo in upravičujejo enako razvrstitev.
To ensure that the information gathered through the registration is kept up-to-date, an obligation on registrants to inform the Agency of certain changes to the information should be introduced.
Da se zagotovi ažurnost informacij, zbranih s pomočjo registracije, bi bilo treba za registracijske zavezance uvesti obveznost, da morajo o določenih spremembah informacij obvestiti Agencijo.
In accordance with Directive 86/609/EEC, it is necessary to replace, reduce or refine testing on vertebrate animals.
V skladu z Direktivo 86/609/EGS je treba testiranja na vretenčarjih nadomestiti, omejiti ali izboljšati.
Implementation of this Regulation should be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of chemicals, wherever possible.
Izvajanje te uredbe bi moralo, kadar koli je mogoče, temeljiti na uporabi alternativnih testnih metod, primernih za ocenjevanje nevarnosti kemikalij za zdravje in okolje.
The use of animals should be avoided by recourse to alternative methods validated by the Commission or international bodies, or recognised by the Commission or the Agency as appropriate to meet the information requirements under this Regulation.
Uporabi živali bi se bilo treba izogibati z izbiro alternativnih metod, ki jih potrdijo Komisija ali mednarodni organi, ali ki jih Komisija ali Agencija priznavata kot primerne za izpolnjevanje informacijskih zahtev iz te uredbe.
To this end, the Commission, following consultation with relevant stakeholders, should propose to amend the future Commission Regulation on test methods or this Regulation, where appropriate, to replace, reduce or refine animal testing.
V ta namen bi morala Komisija po posvetu z ustreznimi interesnimi skupinami predlagati spremembo bodoče uredbe Komisije o testnih metodah ali po potrebi te uredbe, zato da se nadomestijo, omejijo ali izboljšajo testiranja na živalih.
The Commission and the Agency should ensure that reduction of animal testing is a key consideration in the development and maintenance of guidance for stakeholders and in the Agency's own procedures.
Komisija in Agencija bi morali zagotoviti, da bo omejevanje testiranj na živalih ključno vodilo pri razvoju in ohranjanju smernic za interesne skupine ter v postopkih same Agencije.
This Regulation should be without prejudice to the full and complete application of the Community competition rules.
Ta uredba ne bi smela posegati v celotno in popolno uporabo pravil Skupnosti o konkurenci.
In order to avoid duplication of work, and in particular to reduce testing involving vertebrate animals, the provisions concerning preparation and submission of registrations and updates should require sharing of information where this is requested by any registrant.
Da se prepreči podvajanje dela in predvsem zmanjša obseg testov na vretenčarjih, bi morale določbe za pripravo in predložitev registracij in njihove posodobitve zahtevati souporabo informacij, če registracijski zavezanec to zahteva.
If the information concerns vertebrate animals, the registrant should be obliged to request it.
Če se informacije navezujejo na vretenčarje, bi jih registracijski zavezanec moral zahtevati.
It is in the public interest to ensure the quickest possible circulation of test results on human health or environmental hazards of certain substances to those natural or legal persons which use them, in order to limit any risks associated with their use.
V javnem interesu je zagotoviti, da so o rezultatih testov v zvezi z nevarnostjo določenih snovi za zdravje ljudi ali okolje čim prej obveščene tiste fizične in pravne osebe, ki takšne snovi uporabljajo, da se omeji vsako tveganje, povezano z njihovo uporabo.
Sharing of information should occur where this is requested by any registrant, in particular in the case of information involving tests on vertebrate animals, under conditions that ensure a fair compensation for the company that has undertaken the tests.
Informacije bi bilo treba izmenjati, če tako zahteva registracijski zavezanec, zlasti ko informacije vključujejo teste na vretenčarjih, in sicer pod pogoji pravičnega nadomestila podjetju, ki je opravilo teste.
In order to strengthen the competitiveness of Community industry and to ensure that this Regulation is applied as efficiently as possible, it is appropriate to make provision for the sharing of data between registrants on the basis of fair compensation.
Da bi se spodbudila konkurenčnost industrije Skupnosti in zagotovila kar najučinkovitejša uporaba te uredbe, je na podlagi pravičnega nadomestila ustrezno zagotoviti souporabo informacij med registracijskimi zavezanci.
In order to respect the legitimate property rights of those generating testing data, the owner of such data should, for a period of 12 years, be able to claim compensation from those registrants who benefit from that data.
Zaradi spoštovanja zakonitih lastninskih pravic tistih, ki so pridobili podatke s testi, bi bilo treba lastnikom takih informacij kot nadomestilo za pridobitev takšnih podatkov zagotoviti dvanajstletno pravico, da lahko od registracijskih zavezancev, ki uporabljajo te podatke, zahtevajo plačilo.
In order to allow a potential registrant of a phase-in substance to proceed with his registration, even if he cannot reach agreement with a previous registrant, the Agency, on request, should allow use of any summary or robust study summary of tests already submitted.
Da se potencialnemu registracijskemu zavezancu omogoči nadaljevanje registracijskega postopka snovi v postopnem uvajanju, četudi ne more doseči sporazuma s predhodnim registracijskim zavezancem, bi morala Agencija na zahtevo dovoliti uporabo vseh povzetkov ali grobih povzetkov študij testov, ki so že bili predloženi.
The registrant who receives these data should be obliged to pay a contribution to the costs to the owner of the data.
Registracijski zavezanec, ki prejme te podatke, bi moral biti zavezan, da lastniku podatkov plača prispevek k stroškom.
For non-phase-in substances, the Agency may ask for evidence that a potential registrant has paid the owner of a study before the Agency gives permission for the potential registrant to use that information in his registration.
Za snov, ki ni v postopnem uvajanju, lahko Agencija zahteva dokazilo, ki izkazuje, da je morebitni registracijski zavezanec plačal lastniku študije, preden izda Agencija dovoljenje morebitnemu registracijskemu zavezancu za uporabo podatkov iz njegove registracije.
In order to avoid duplication of work, and in particular to avoid duplication of testing, registrants of phase-in substances should pre-register as early as possible with a database managed by the Agency.
Da se prepreči podvajanje dela in zlasti podvajanje testiranj, bi se morali registracijski zavezanci za snovi v postopnem uvajanju čim prej predhodno registrirati v eni od zbirk podatkov, ki jih vodi Agencija.
A system should be established in order to provide for the establishment of Substance Information Exchange Forums (SIEF) to help exchange of information on the substances that have been registered.
Treba bi bilo vzpostaviti sistem, ki bo vzpostavil forume za izmenjavo informacij o snoveh (SIEF) in pomagal izmenjavati informacije o registriranih snoveh.
SIEF participants should include all relevant actors submitting information to the Agency on the same phase-in substance.
V SIEF bi morali sodelovati vsi zadevni udeleženci, ki Agenciji posredujejo informacije o isti snovi v postopnem uvajanju.
They should include both potential registrants, who must provide and be supplied with any information relevant to the registration of their substances, and other participants, who may receive financial compensation for studies they hold but are not entitled to request information.
Sodelovati bi morali potencialni registracijski zavezanci, ki morajo zagotavljati in prejemati vse za registracijo svojih snovi pomembne informacije, in drugi udeleženci, ki utegnejo za svoje študije prejemati finančno nadomestilo, vendar nimajo pravice zahtevati informacij.
In order to ensure the smooth functioning of that system they should fulfil certain obligations.
Da se zagotovi nemoteno delovanje takšnega sistema, bi morali izpolnjevati določene obveznosti.
If a member of a SIEF does not fulfil his obligations, he should be penalised accordingly but other members should be enabled to continue preparing their own registration.
Če član SIEF ne izpolnjuje svojih obveznosti, bi ga bilo treba ustrezno kaznovati, drugim članom pa bi bilo treba omogočiti, da nadaljujejo pripravo svoje registracije.
In cases where a substance has not been pre-registered, measures should be taken to help downstream users find alternative sources of supply.
Če snov še ni predhodno registrirana, bi bilo treba sprejeti ukrepe za pomoč nadaljnjemu uporabniku pri iskanju alternativnih virov za oskrbo.
Manufacturers and importers of a substance on its own or in a preparation should be encouraged to communicate with the downstream users of the substance with regard to whether they intend to register the substance.
Proizvajalce in uvoznike snovi kot take ali v pripravku bi bilo treba spodbujati, da nadaljnje uporabnike snovi obveščajo, ali nameravajo snov registrirati.
Such information should be provided to a downstream user sufficiently in advance of the relevant registration deadline if the manufacturer or importer does not intend to register the substance, in order to enable the downstream user to look for alternative sources of supply.
Če proizvajalec ali uvoznik snovi ne namerava registrirati, bi moral o tem pravočasno pred pretekom roka za registracijo obvestiti nadaljnjega uporabnika, da lahko nadaljnji uporabnik poišče alternativne vire za oskrbo.
Part of the responsibility of manufacturers or importers for the management of the risks of substances is the communication of information on these substances to other professionals such as downstream users or distributors.
Sestavni del odgovornosti proizvajalcev ali uvoznikov za obvladovanje tveganja v zvezi s snovmi je sporočanje informacij o teh snoveh drugim, ki jih to poklicno zadeva, kot na primer nadaljnjim uporabnikom ali distributerjem.
In addition, producers or importers of articles should supply information on the safe use of articles to industrial and professional users, and consumers on request.
Hkrati bi morali izdelovalci ali uvozniki izdelkov na zahtevo predložiti podatke o varni uporabi izdelkov industrijskim in poklicnim uporabnikom ter potrošnikom.
This important responsibility should also apply throughout the supply chain to enable all actors to meet their responsibility in relation to management of risks arising from the use of substances.
Ta pomembna odgovornost bi morala veljati tudi za celotno dobavno verigo, da lahko vsi delujoči izpolnjujejo svoje obveznosti glede obvladovanja tveganja, ki izhaja iz uporabe snovi.
As the existing safety data sheet is already being used as a communication tool within the supply chain of substances and preparations, it is appropriate to develop it further and make it an integral part of the system established by this Regulation.
Ker se obstoječi varnostni list že uporablja kot sredstvo obveščanja v dobavni verigi snovi in pripravkov, je ustrezno, da se razvija naprej in vključi v sistem, vzpostavljen s to uredbo.
In order to have a chain of responsibilities, downstream users should be responsible for assessing the risks arising from their uses of substances if those uses are not covered by a safety data sheet received from their suppliers, unless the downstream user concerned takes more protective measures than those recommended by his supplier or unless his supplier was not required to assess those risks or provide him with information on those risks.
Da se vzpostavi veriga odgovornosti, bi morali biti nadaljnji uporabniki odgovorni za oceno tveganja, ki izhaja iz njihove uporabe snovi, če te uporabe niso vključene v varnostni list, ki ga prejmejo od dobaviteljev, razen če zadevni nadaljnji uporabnik ne sprejme strožjih varnostnih ukrepov od ukrepov, ki jih priporoči njegov dobavitelj, ali če od svojega dobavitelja ni zahteval, da oceni to tveganje ali da zagotovi informacije o tem tveganju.
For the same reason, downstream users should manage the risks arising from their uses of substances.
Iz istih razlogov bi morali nadaljnji uporabniki obvladovati tveganje, ki izhaja iz njihove uporabe snovi.
In addition, it is appropriate that any producer or importer of an article containing a substance of very high concern should provide sufficient information to allow safe use of such an article.
Hkrati bi moral vsak izdelovalec ali uvoznik izdelka, ki vsebuje snov, ki zbuja veliko skrb, zagotoviti zadostne informacije za varno uporabo takega izdelka.
The requirements for undertaking chemical safety assessments by downstream users should also be prescribed in detail to allow them to meet their obligations.
Podrobno bi bilo treba predpisati tudi zahteve za ocene kemijske varnosti, ki jih izvedejo nadaljnji uporabniki, da ti lahko izpolnijo svoje obveznosti.
These requirements should only apply above a total quantity of one tonne of substance or preparation.
Te zahteve bi morale veljati samo nad skupno količino eno tono za snov ali pripravek.
In any case, however, the downstream users should consider the use and identify and apply appropriate risk management measures.
Vendar pa bi moral nadaljnji uporabnik v vsakem primeru premisliti o uporabi in določiti ter uporabiti ustrezne ukrepe za obvladovanje tveganja.
Downstream users should report certain basic information on use to the Agency.
Nadaljnji uporabniki bi morali Agenciji posredovati določene osnovne informacije o uporabi.
For enforcement and evaluation purposes, downstream users of substances should be required to report to the Agency certain basic information if their use is outside the conditions of the exposure scenario detailed in the safety data sheet communicated by their original manufacturer or importer and to keep such reported information up-to-date.
Za izvrševanje in evalvacijo bi bilo treba od nadaljnjih uporabnikov snovi zahtevati, da Agenciji sporočijo določene osnovne informacije, če njihova uporaba ne sodi med pogoje predvidenega scenarija izpostavljenosti, podrobno opisanega v varnostnem listu, ki jim ga pošlje njihov prvotni proizvajalec ali uvoznik, ter tako sporočene informacije posodabljajo.
For reasons of workability and proportionality, it is appropriate to exempt downstream users using low quantities of a substance from such reporting.
Zaradi izvedljivosti in sorazmernosti je ustrezno, da se nadaljnji uporabniki, ki uporabljajo manjše količine snovi, izvzamejo iz takšnega sporočanja.
Communication up and down the supply chain should be facilitated.
Treba bi bilo olajšati obveščanje znotraj dobavne verige.
The Commission should develop a system categorising brief general descriptions of uses taking into account the outcomes of the RIPs.
Komisija bi morala oblikovati sistem, s katerim se razvrstijo kratki splošni opisi uporab ob upoštevanju rezultatov RIP.
It is also necessary to ensure that generation of information is tailored to real information needs.
Prav tako je treba zagotoviti, da se pridobivanje takšnih informacij prilagodi dejanskim potrebam po informacijah.
To this end evaluation should require the Agency to decide on the programmes of testing proposed by manufacturers and importers.
Zato bi se morala Agencija odločiti glede programov testiranja, ki jih za takšne snovi predlagajo proizvajalci in uvozniki.
In cooperation with Member States, the Agency should give priority to certain substances, for instance those which may be of very high concern.
Agencija bi morala v sodelovanju z državami članicami dati prednost določenim snovem, na primer tistim, ki zbujajo veliko skrb.