natgillin/translations-raw huggingface dataset:
Za spodbujanje inovativnosti je treba v proizvode in postopke usmerjene raziskave in razvoj za določen čas izvzeti iz obveznega registriranja, če snov še ni namenjena, da se da v promet za nedoločeno število kupcev, ker njena uporaba v pripravkih ali izdelkih zahteva še dodatne raziskave in razvoj, ki jih opravi omejeno število znanih kupcev.
However, in order to encourage innovation, research on products and process oriented research and development should be exempted from the obligation to register for a certain time period where a substance is not yet intended to be placed on the market to an indefinite number of customers because its application in preparations or articles still requires further research and development performed by a limited number of known customers.
Ker morajo proizvajalci in uvozniki izdelkov odgovarjati za svoje izdelke, je primerno, da se uvede zahteva za registriranje snovi, ki naj bi se sprostile iz teh izdelkov.
Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles.
O snoveh,
In the case of substances which
ki izpolnjujejo merila iz člena 63 in so zato bile vključene na seznam snovi, ki izpolnjujejo merila za pridobitev dovoljenja (Priloga XIII(a)),
fulfill the criteria of Article 63 and have, therefore, been included in the list of substances that meet the criteria for authorisation (Annex XIII(a)), the relevant authorities should be informed and consulted immediately and
je treba obvestiti Agencijo.
the Agency should be notified.
V tehnični prilogi je treba podrobno predpisati zahteve za ocene kemijske varnosti, ki jih izvedejo proizvajalci in uvozniki, da lahko izpolnijo svoje obveznosti.
The requirements for undertaking chemical safety assessments by manufacturers and importers should be prescribed in detail in a technical annex to allow them to meet their obligations.
Da se obremenitev pravično porazdeli s kupci, morajo proizvajalci in uvozniki v svoji oceni kemijske varnosti poleg svojih uporab in uporab, za katere dajo snovi v promet, obravnavati tudi uporabe, za katere zaprosijo njihovi kupci.
To achieve fair burden sharing with their customers, manufacturers and importers should in their chemical safety assessment address not only their own uses and the uses for which they place their substances on the market, but also all uses which their customers ask them to address.
Ocene kemijske varnosti ni treba izvesti za snovi, ki jih vsebujejo pripravki v določenih, zelo majhnih koncentracijah, za katere velja, da ne zbujajo skrbi.
A chemical safety assessment should not need to be performed for substances in preparations in certain very small concentrations which are considered as not giving rise to concern.
Snovi, ki jih v tako nizkih koncentracijah vsebujejo pripravki, je treba tudi izvzeti iz zahteve za pridobitev dovoljenja.
Substances in preparations in such low concentrations should also be exempt from authorisation.
Te določbe je treba enako uporabljati za pripravke, ki so trdne zmesi snovi, vse dokler ne dobijo določene oblike, ki jih spremeni v izdelek.
These provisions should apply equally to preparations that are solid mixtures of substances until a specific shape is given to such a preparation that transforms it into an article.
Enemu iz skupine večkratnih registracijskih zavezancev je treba omogočiti, da lahko v skladu s pravili predloži informacije v imenu drugih, kar zagotavlja predložitev vseh zahtevanih informacij ob hkratni porazdelitvi stroškovne obremenitve.
One of a group of multiple registrants should be allowed to submit information on behalf of the others according to rules which ensure that all the required information is submitted, while allowing sharing of the costs burden.
Zahteve za pridobivanje informacij o snoveh je treba stopnjevati v skladu s proizvedeno ali uvoženo količino snovi, ker se na podlagi teh količin lahko določi, kakšna je verjetnost, da bodo tem snovem izpostavljeni ljudje ali okolje; informacije pa je treba podrobno opisati.
Requirements for generation of information on substances should be tiered according to the volume of manufacture or importation of a substance, because these provide an indication of the potential for exposure of man and the environment to the substances, and should be described in detail.
Če se izvajajo preskusi, morajo biti v skladu z ustreznimi zahtevami za varstvo laboratorijskih živali iz Direktive Sveta 86/609/EGS z dne 24. novembra 1986 o prilagajanju zakonov in drugih predpisov držav članic o varstvu živali, ki se uporabljajo v poskusne in druge znanstvene namene UL L 358, 18.12.1986, str.
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 OJ L 358, 18.12.1986, p.
, ter dobro laboratorijsko prakso iz
, and good laboratory practice, set out
Direktive 2004/10/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004
in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004
o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri preskusih kemičnih snovi UL L
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 OJ L
Pridobivanje informacij je treba omogočiti tudi na druge načine, enakovredne predpisanim preskusom in preskusnim metodam, na primer z uporabo veljavnih modelov kakovostne ali količinske strukturne dejavnosti ali strukturno sorodnih snovi.
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.
V ta namen mora Agencija v sodelovanju z državami članicami in zainteresiranimi stranmi pripraviti ustrezna navodila.
To this end the Agency, in cooperation with Member States and interested parties, should develop appropriate guidance.
Treba je tudi omogočiti, da določenih informacij ni treba predložiti, če se lahko zagotovi ustrezna utemeljitev.
It should also be possible not to submit certain information if appropriate justification can be provided.
Glede na posebne okoliščine malih in srednje velikih podjetij (MSP) morajo države članice sprejeti ukrepe za zagotavljanje posebne podpore takšnim podjetjem za opravljanje preskusov, nujnih za zbiranje podatkov, ki jih zahteva ta uredba.
In the light of the particular circumstances of small and medium-sized enterprises (SMEs), Member States should adopt measures to provide special assistance to such enterprises for conducting the tests needed to collect the information required under this Regulation.
Da pomagajo družbam in še zlasti malim in srednje velikim podjetjem pri izpolnjevanju zahtev te uredbe, morajo države članice v sodelovanju s Komisijo vzpostaviti obsežno podporno mrežo.
In order to help companies, and in particular SMEs, to comply with the requirements of this Regulation, the Member States, in cooperation with the Commission, should put in place a comprehensive support network.
Zaradi preglednosti in da se podjetjem olajša pravilna uporaba zahtev je treba predpisane preskusne metode med seboj združevati.
Prescribed test methods should be consolidated for reasons of transparency as well as to facilitate good application of the requirements by enterprises.
Za vmesne proizvode je treba zaradi izvedljivosti in njihove posebne narave določiti posebne registracijske zahteve; polimere je treba izvzeti iz registracije in ovrednotenja, razen tistih, ki jih je treba registrirati zaradi nevarnosti, ki jo pomenijo za zdravje ljudi ali okolje, ter se lahko določijo na izvedljiv in stroškovno uspešen način na podlagi utemeljenih tehničnih in veljavnih znanstvenih meril.
For reasons of workability and because of their special nature, specific registration requirements should be laid down for intermediates; 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.
Zaradi izvedljivosti bi bilo potrebno odpadke in materiale, ki se uporabljajo kot sekundarne surovine ali energetski viri, izvzeti.
For reasons of workability, wastes and materials used as secondary raw material or as a source of energy should be exempted.
Ustvarjanje vrednosti ("valorizacija") iz odpadkov in snovi, uporabljenih kot surovine ali vir energije v postopkih predelave, prispeva k doseganju ciljev trajnostnega razvoja EU in ta uredba ne sme uvesti zahtev, ki zmanjšujejo pobude za tako recikliranje in predelavo.
Generating value ("valorisation") from wastes and materials used as secondary raw material or as a source of energy in recovery operations contributes to the European Union's objective of sustainable development, and this Regulation must not introduce requirements which reduce the incentives for such recycling and recovery.
Da se prepreči prevelika obremenitev organov in podjetij z delom, povezanim z registracijo snovi, ki so že na notranjem trgu, je treba to registracijo razporediti v ustreznem časovnem obdobju, brez povzročanja nepotrebnih zamud.
To avoid overloading authorities and enterprises with the work arising from the registration of substances already on the internal market, that registration should be spread over an appropriate period of time, without introducing undue delay.
Zato je treba določiti roke za registracijo teh snovi.
Deadlines for the registration of these substances should therefore be set.
Podatke o snoveh, ki so že prijavljene v skladu z Direktivo 67/548/EGS, je treba prevzeti v sistem in razširiti, ko se doseže naslednji količinski prag.
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.
Da se zagotovi usklajen in enostaven sistem, je treba vse registracije predložiti Agenciji.
In order to provide a harmonised, simple system, all registrations should be submitted to the Agency.
Da se zagotovi dosleden pristop in učinkovita uporaba virov, pa mora Agencija opraviti pregled popolnosti za vse registracije in prevzeti odgovornost za vse dokončne zavrnitve registracij.
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 sprotno dopolnjevanje informacij, ki so na voljo organom, je treba uvesti
To ensure that the information available to the authorities is kept up-to-date, a
obvestijo Agencijo
to inform the Agency
, ki nosi celotno odgovornost
, which bears overall responsibility,
Treba je spodbujati izmenjavo informacij in njihovo skupno predložitev, da se poveča učinkovitost te uredbe v vsej Skupnosti.
The sharing and joint submission of information should be encouraged to increase the efficiency of this Regulation throughout the Community.
ali drugi mednarodni organi.
or other international bodies.
Učinkovitejše usklajevanje sredstev na ravni Skupnosti bo prispevalo k povečanju števila znanstvenih spoznanj, ki so nujna pri razvoju nadomestnih metod za poskuse na vretenčarjih.
Better coordination of resources at Community level will contribute to increasing the scientific knowledge indispensable for the development of alternative methods to that of experimentation on vertebrate animals.
V te namene je bistvenega pomena, da si Skupnost še naprej vztrajno prizadeva ter sprejme potrebne ukrepe za spodbujanje raziskovanja in razvoja novih nadomestnih metod, ki ne vključujejo živali, še zlasti v okviru sedmega okvirnega programa za raziskave in tehnološki razvoj.
It is essential, for this purpose, that the Community continue and increase its efforts and take the necessary measures for the promotion of research and the development of new non-animal alternative methods, in particular within its Seventh Framework Programme for Research and Technological Development.
Da se spodbujajo preskusi, ki ne vključujejo živali, morajo Komisija, države članice in industrija dodeliti več sredstev za razvoj, potrjevanje in sprejetje preskusov brez postopkov na živalih.
In order to promote non-animal testing, the Commission, Member States and industry should allocate more resources to the development, validation and acceptance of non-animal tests.
Del pristojbin, ki se plačajo Agenciji, mora biti dodeljen v ta namen.
Part of the fees paid to the Agency should be allocated for that purpose.
Ta uredba ne sme posegati v neomejeno uporabo pravil Skupnosti o konkurenci.
This Regulation should be without prejudice to the full and complete application of the Community competition rules.
Da se prepreči podvajanje dela, predvsem pa da se zmanjša obseg preskusov na vretenčarjih, morajo zahteve za pripravo in predložitev registracij ter njihove prilagoditve zadnjemu stanju registracijske zavezance spodbujati, da preverijo zbirke podatkov, vzpostavljene pri Agenciji, in sprejmejo vse ustrezne ukrepe za dosego sporazuma o izmenjavi informacij.
In order to avoid duplication of work, and in particular to reduce testing involving vertebrate animals, the requirements concerning preparation and submission of registrations and updates should encourage registrants to check the databases established at the Agency and to take all reasonable steps to reach an agreement on the sharing of information.
V javnem interesu je zagotoviti, da so o rezultatih preskusov v zvezi z nevarnostjo določenih snovi za zdravje ljudi ali okolje čim prej obveščena podjetja, ki takšne snovi uporabljajo, da se omeji vsako tveganje, povezano z njihovo uporabo.
It is in the public interest to ensure the quickest possible circulation of test results on the human health or environmental hazards of certain substances to those enterprises which use them, in order to limit any risks associated with their use.
Zato je treba spodbujati izmenjavo informacij pod pogoji, ki zagotavljajo pošteno nadomestilo podjetju, ki je opravilo preskuse.
Sharing of information should therefore be encouraged, under conditions that ensure a fair recompense for the company that has undertaken the tests.
Da se okrepi konkurenčnost industrije Skupnosti in zagotovi, da se ta uredba čim bolj učinkovito uporablja, je primerno zagotoviti izmenjavo podatkov med registracijskimi zavezanci na podlagi pravičnega nadomestila.
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.
Zaradi spoštovanja zakonitih lastninskih pravic tistih, ki so pridobili podatke s preskusi, je treba tem kot nadomestilo za pridobitev takšnih podatkov zagotoviti desetletno pravico, da lahko od tistih registracijskih zavezancev, ki uporabljajo te podatke, zahtevajo plačilo.
In order to respect the legitimate property rights of those generating testing data, the generator of such data should, for a period of 10 years, be able to claim compensation from those registrants who benefit from that data.
Da se potencialnemu registracijskemu zavezancu omogoči nadaljevanje registracijskega postopka, četudi ne more doseči sporazuma s predhodnim registracijskim zavezancem, da Agencija na zahtevo na razpolago vse predložene povzetke ali zanesljive študijske povzetke preskusov.
In order to allow a potential registrant to proceed with his registration, even if he cannot reach agreement with a previous registrant, the Agency, on request, should make available any summary or robust study summary of tests already submitted.
Registracijski zavezanec, ki prejme te podatke, mora plačati prispevek k stroškom za pridobitev podatkov.
The registrant who receives these data should be obliged to pay a contribution to the costs to the generator of the data.
Če potencialni registracijski zavezanec in/ali udeleženec foruma za izmenjavo informacij o snoveh (SIEF) ne poravna svojega deleža stroškov študije, ki vključuje preskuse na vretenčarjih, ali druge študije, ki lahko prepreči preskuse na živalih, ne more registrirati svoje snovi.
If a potential registrant and/or participant in a substance information exchange forum (SIEF) fails to pay his share of the cost of a study involving tests on vertebrate animals or another study that may prevent animal testing, he should not be able to register his substance.
Da se prepreči podvajanje dela in zlasti podvajanje preskusov, se morajo registracijski zavezanci za snovi v postopnem uvajanju čim prej predhodno registrirati v eni od zbirk podatkov, ki jih vodi Agencija.
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.
Treba je vzpostaviti sistem, ki bo registracijskim zavezancem pomagal poiskati druge registracijske zavezance in ustanoviti konzorcij.
A system should be established in order to help registrants to find other registrants and form consortia.
Da se zagotovi nemoteno delovanje takšnega sistema, morajo biti izpolnjene določene obveznosti.
In order to ensure the smooth functioning of that system they should fulfil certain obligations.
Če lastniku študije, ki vključuje preskuse na vretenčarjih, ali druge študije, ki lahko prepreči preskuse na živalih, ne uspe dati študije na razpolago Agenciji in/ali drugim možnim registracijskim zavezancem, ne more registrirati svoje snovi.
If the owner of a study involving tests on vertebrate animals or another study that may prevent animal testing fails to make the study available to the Agency and/or other potential registrants, he should not be able to register his substance.
Sestavni del odgovornosti za obvladovanje tveganja v zvezi s snovmi je sporočanje informacij o teh snoveh drugim, ki jih to poklicno zadeva
Part of the responsibility for the management of the risks of substances is the communication of information on these substances to other professionals
, in tistim, ki jih ne, na najustreznejši možen način
and to non-professionals via the most appropriate means possible
morajo nujno izpolnjevati svoje odgovornosti
to meet their responsibility
Obveščanje o tveganju je pomemben del postopka obveščanja in svetovanja ljudem o tem, kako lahko obvladujejo možna tveganja in tako varno in učinkovito uporabijo snov ali pripravek.
Risk communication is a vital part of the process of informing and advising people about how they can manage potential risks and so use a substance or preparation safely and effectively.
Obveščanje o tveganju zahteva razumevanje potreb uporabnikov po podatkih s strani proizvajalca ter zagotovitev teh podatkov, nasvetov in pomoči za podporo varne uporabe snovi ali pripravka s strani končnega uporabnika.
Risk communication requires an understanding by the manufacturer of the information needs of users, and the subsequent provision of that information, advice and help to support the safe use of the substance or preparation by the end user.
Razvoj ustreznega komunikacijskega sistema na podlagi tveganja, vključno z zagotovitvijo dopolnjevalne uporabe podatkov, na primer spletne strani in izobraževalne kampanje, si mora prizadevati, da zadosti pravici potrošnikov, da so obveščeni o snoveh in pripravkih, ki jih uporabljajo.
The development of an appropriate risk-based communication system, including the provision of complementary information using, for example, websites and educational campaigns, should be pursued in order to satisfy the right of consumers to know about the substances and preparations they use.
Ker se obstoječi varnostni list že uporablja kot sredstvo obveščanja v dobavni verigi snovi in preparatov, je ustrezno, da se razvija naprej in vključi v sistem, vzpostavljen s to uredbo.
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.
Vseeno je treba razmisliti o drugih metodah sporočanja podatkov potrošnikom o tveganju in varni uporabi snovi in preparatov.
However, other methods of communicating information on the risks and safe use of substances and preparations should be considered for consumers.
Da se vzpostavi veriga odgovornosti, morajo biti uporabniki na nižji stopnji 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 uporabnik na nižji stopnji 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; zaradi tega morajo uporabniki na nižji stopnji obvladovati tveganje, ki izhaja iz njihove uporabe snovi
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; for the same reason, downstream users should manage the risks arising from their uses of substances
Podrobno je treba predpisati tudi zahteve za ocene kemijske varnosti, ki jih izvedejo uporabniki na nižji stopnji, da ti lahko izpolnijo svoje obveznosti.
The requirements for undertaking chemical safety assessments by downstream users should also be prescribed in detail to allow them to meet their obligations.
Uporabniki na nižji stopnji sporočijo tveganje, kot je poudarjeno v oceni kemijske varnosti, na najučinkovitejši in najustreznejši možni način za uporabnika snovi ali pripravka v nekem trenutku v dobavni verigi/življenjskem ciklu ter zagotovijo svetovanje potrošniku za varno uporabo.
The downstream user must report the risks as highlighted in the chemical safety assessment by the most effective and relevant means possible for the user of the substance or preparation at a given point in the supply chain/life-cycle and provide advice on safe use for consumers.
Za izvajanje in vrednotenje je treba od uporabnikov snovi na nižji stopnji zahtevati, da sporočijo določene informacije, če njihova uporaba ne spada pod pogoje predvidenega poteka izpostavljenosti, podrobno opisanega v varnostnem listu, ki jim ga pošlje njihov prvotni proizvajalec ali uvoznik, ter tako sporočene informacije sproti dopolnjujejo.
For enforcement and evaluation purposes, downstream users of substances should be required to report certain 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.
Zaradi izvedljivosti in sorazmernosti je ustrezno, da se uporabniki na nižji stopnji, ki uporabljajo manjše količine snovi, izvzamejo iz takšnega sporočanja.
For reasons of workability and proportionality, it is appropriate to exempt downstream users using low quantities of a substance from such reporting.
Če proizvajalec snovi ali uvoznik snovi, kot take ali v pripravku, ne namerava vložiti registracije za snov, o tem ustrezno obvesti Agencijo in svoje uporabnike na nižji stopnji.
If a manufacturer of a substance or an importer of a substance, either on its own or in a preparation, does not intend to submit a registration for a substance, he must notify the Agency and his downstream users accordingly.