natgillin/translations-raw huggingface dataset:
Odločitev za izdajo odobritve v skladu z odstavkom 2 se sprejme po preučitvi vseh naslednjih dejavnikov:
The decision to grant authorisation pursuant to paragraph 2 shall be taken after consideration of all of the following elements:
(Predlog spremembe 233 – prva obravnava)
(Amendment 233 - first reading)
Če vloga za odobritev vključuje informacije iz člena 61(5)(b), se te upoštevajo pri določitvi trajanja časovno omejenega roka za preverjanje iz odstavka 8 tega člena.
Where an application for authorisation includes the information specified in Article 61(5)(b), this information shall be considered in determining the duration of the time-limited review period in paragraph 8 of this Article.
Obdobje veljavnosti časovno omejene odobritve se določi na osnovi informacij, ki so podrobno opredeljene v členu 61(4)(eb), in ob upoštevanju drugih razpoložljivih informacij.
The duration of the time-limited authorisation will be determined on the basis of the information specified in Article 61(4)(eb) and taking into account other available information.
Poveže se obdobje veljavnosti odobritve z informacijami, ki jih vsebuje načrt nadomestitve.
Links the duration of the authorisation to the information contained in the substitution plan.
Odobritve se preverjajo v časovno omejenem roku (čigar trajanje se določi za vsak primer posebej) brez poseganja v odločitve glede prihodnjega obdobja preverjanja; običajno zanje veljajo določeni pogoji, vključno s spremljanjem.
Authorisations shall be subject to a time-limited review (whose duration shall be determined on a case-by-case basis) without prejudice to any decision on a future review period and shall normally be subject to conditions, including monitoring.
Odobritve se preverjajo v rokih in pogojujejo s predstavitvijo načrtov nadomestitve ter zanje lahko veljajo drugi pogoji, vključno s spremljanjem.
Authorisations shall be subject to review periods and to the presentation of substitution plans, and may be subject to other conditions, including monitoring.
Za odobritve velja rok veljavnosti največ pet let.
Authorisations shall be subject to a time-limit not exceeding five years.
(Predlog spremembe 235 – prva obravnava)
(Amendment 235 - first reading)
Odobritve morajo imeti omejen rok veljavnosti, da se spodbujajo inovacije.
Authorisations must be subject to a time limit to give an incentive for innovation.
(d) pogoji, pod katerimi se dodeli odobritev;
(d) any conditions under which the authorisation is granted;
(d) pogoji, pod katerimi se izda dovoljenje;
(d) the conditions under which the authorisation is granted;
(e) časovno omejen rok za preverjanje;
(e) the time-limited review period;
(e) rok za preverjanje;
(e) the review period;
(Predloga spremembe 236 in 359 (delno) – prva obravnava)
(Amendment 236 and 359 (partially) - first reading)
Razjasni se besedilo.
Clarifies the wording.
Odobritve , dodeljene v skladu s členom 59, veljajo, dokler se Komisija ne odloči, da v okviru preverjanja odobritve spremeni ali umakne , če imetnik odobritve predloži oceno o preverjanju vsaj 18 mesecev pred potekom časovno omejenega roka za preverjanje .
Authorisations granted in accordance with Article 59 shall be regarded as valid until the Commission decides to amend or withdraw the authorisation in the context of a review , provided that the holder of the authorisation submits a review report at least 18 months before the expiry of the time-limited review period .
Namesto ponovne predložitve vseh sestavnih delov prvotne vloge za trenutno veljavno odobritev lahko imetnik odobritve predloži samo številko trenutno veljavne odobritve , ob upoštevanju drugega, tretjega in četrtega pododstavka.
Rather than re-submitting all elements of the original application for the current authorisation, the holder of an authorisation may submit only the number of the current authorisation, subject to the second, third and fourth subparagraphs.
Odobritve veljajo, dokler se Komisija ne odloči o novi vlogi, če imetnik odobritve predloži novo vlogo vsaj 18 mesecev pred potekom časovnega roka.
Authorisations shall be regarded as valid until the Commission decides on a new application , provided that the holder of the authorisation submits a new application at least 18 months before the expiry of the time-limit .
Namesto ponovne predložitve vseh sestavnih delov prvotne vloge za trenutno veljavno odobritev lahko vlagatelj predloži samo :
Rather than re-submitting all elements of the original application for the current authorisation, the applicant may submit only :
Imetnik odobritve, izdane v skladu s členom 59, predloži vse načrte nadomestitve iz svoje vloge, ki so prilagojene zadnjemu stanju.
A holder of an authorisation granted in accordance with Article 59 shall submit an update of any substitution plan included in his application.
Če imetnik ne more dokazati, da je tveganje pod ustreznim nadzorom, predloži zadnjemu stanju prilagojeno socialno-ekonomsko analizo, analizo alternativ in načrt nadomestitve iz prvotne vloge.
If the holder cannot demonstrate that the risk is adequately controlled, he shall submit an update of the socio-economic analysis, analysis of alternatives and substitution plan contained in the original application .
(a) številko trenutno veljavne odobritve,
(a) the number of the current authorisation,
(b) zadnjemu stanju prilagojeno socialno-ekonomsko analizo, analizo alternativ in načrt nadomestitve iz prvotne vloge ,
(b) an update of the socio-economic analysis, analysis of alternatives and substitution plan contained in the original application ,
Če potem lahko dokaže, da je tveganje pod ustreznim nadzorom, predloži zadnjemu stanju prilagojeno poročilo o kemijski varnosti.
If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report.
(c) zadnjemu stanju prilagojeno poročilo o kemijski varnosti.
(c) an update of the chemical safety report.
(Predlog spremembe 237 – prva obravnava)
(Amendment 237 - first reading)
Med pregledom odobritve mora vlagatelj ponovno predložiti le tiste sestavne dele prvotne vloge, ki jih je treba posodobiti.
During the review of an authorisation the applicant needs only to re-submit the elements of the original application that need to be updated.
Povezano s predlogom spremembe člena 54.
Linked to amendment to Article 54.
Odobritev se lahko preveri kadar koli, če:
Authorisations may be reviewed at any time if:
Odobritev se preveri kadar koli, če:
Authorisations shall be reviewed at any time if:
(Predlog spremembe 238 (delno) – prva obravnava)
(Amendment 238 (partially) - first reading)
Ta predlog spremembe omogoča Agenciji hitro odzivanje na spreminjajoče se razmere.
This amendment enables the Agency to react quickly to changing circumstances.
Odobritve bi se morale samodejno preverjati, če se okoliščine iz prvotne odobritve spremenijo tako, da pomenijo tveganje za zdravje ljudi ali okolje ali postanejo razpoložljive nove informacije o socialno-ekonomskih posledicah ali o morebitnih nadomestnih možnostih.
Authorisations should be automatically reviewed if the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio-economic impact or new information on possible substitutes becomes available.
Uvaja se obveznost preverjanja odobritev, če se okoliščine spremenijo.
Introduces the obligation to review authorisations if the circumstances have changed.
V primerih, ko je resno in neposredno ogroženo zdravje ljudi ali okolje, lahko Komisija odobritev ob upoštevanju načela sorazmernosti začasno prekliče, dokler traja preverjanje.
In cases where there is a serious and immediate risk for human health or the environment, the Commission may suspend the authorisation pending the review, taking into account the principle of proportionality.
V primerih, ko je ogroženo zdravje ljudi ali okolje, lahko Komisija odobritev ob upoštevanju načela sorazmernosti začasno prekliče, dokler traja preverjanje.
In cases where there is a risk for human health or the environment, the Commission may suspend the authorisation pending the review, taking into account the principle of proportionality.
(Predlog spremembe 239 – prva obravnava)
(Amendment 239 - first reading)
Za opredelitev „resnega in neposrednega“ tveganja ni nobenih meril.
No criteria exist for the definition of a 'serious and immediate' risk.
Zato se mora Komisija na podlagi meril odločiti, ali je treba odobritev med pregledom začasno preklicati.
It is therefore up to the Commission to decide, on the basis of criteria, whether or not to suspend authorisation during the review.
Če ni izpolnjen okoljski standard kakovosti iz Direktive 96/61/ES, se lahko preverijo odobritve, dodeljene za uporabo zadevne snovi.
If an environmental quality standard referred to in Directive 96/61/EC is not met, the authorisations granted for the use of the substance concerned may be reviewed.
Če ni izpolnjen okoljski standard kakovosti iz Direktive 96/61/ES, se preverijo odobritve, dodeljene za uporabo zadevne snovi.
If an environmental quality standard referred to in Directive 96/61/EC is not met, the authorisations granted for the use of the substance concerned shall be reviewed.
(Predlog spremembe 240 – prva obravnava)
(Amendment 240 - first reading)
Ta predlog spremembe zagotavlja skladnost z direktivo IPPC in z uvedbo obveznosti preverjanja odobritev omogoča Agenciji odzivanje na spreminjajoče se razmere.
This amendment ensures coherence with the IPPC Directive and enables the Agency to react to changing circumstances by introducing an obligation to review authorisations.
Če niso izpolnjeni okoljski cilji iz člena 4(1) Direktive 2000/60/ES, se lahko preverijo odobritve, dodeljene za uporabo zadevne snovi v ustreznem porečju.
If the environmental objectives as referred to in Article 4(1) of Directive 2000/60/EC are not met, the authorisations granted for the use of the substance concerned in the relevant river basin may be reviewed .
Če niso izpolnjeni okoljski cilji iz člena 4(1) Direktive 2000/60/ES, se preverijo odobritve, dodeljene za uporabo zadevne snovi v ustreznem porečju.
If the environmental objectives as referred to in Article 4(1) of Directive 2000/60/EC are not met, the authorisations granted for the use of the substance concerned in the relevant river basin shall be reviewed .
(Nov predlog spremembe, v skladu s členom 62(2)(d) Poslovnika, glede na KOM 2006/397 z dne 17. julija 2006)
(New amendment - Rule 62(2)(d) in light of COM 2006/397 of 17 July 2006)
Julija 2006 je Komisija sprejela predlog nove hčerinske direktive o okoljskih standardih kakovosti na področju vodne politike s sklicevanjem na člen 4(1) direktive 2000/60.
In July 2006, the Commission adopted a proposal for a new daughter directive on environmental quality standards in the field of water policy with reference to Article 4(1) of Directive 2000/60.
Da bi se preprečilo morebitno „prelaganje odgovornosti“, je treba zagotoviti možnost uresničevanja potrebnih ciljev v okviru REACH in to z obveznim pregledom vsake odobritve, če okoljski cilji niso uresničeni.
To prevent any "passing of the buck", it must be ensured that the necessary objectives can be achieved via REACH via compulsory revision of any authorisation if the environmental objectives are not met.
Vloga lahko vključuje:
The application may include:
(a) socialno-ekonomsko analizo, izvedeno v skladu s Prilogo XVI;
(a) a socio-economic analysis conducted in accordance with Annex XVI;
(ea) socialno-ekonomsko analizo, izvedeno v skladu s Prilogo XVI;
(ea) a socio-economic analysis conducted in accordance with Annex XVI;
(b) kjer je to ustrezno, načrt nadomestitve, ki vključuje raziskave in razvoj ter časovni razpored ukrepov, ki jih predlaga vlagatelj;
(b) where appropriate a substitution plan, including research and development and a timetable for proposed actions by the applicant;
(eb) načrt nadomestitve, ki vključuje raziskave in razvoj ter časovni razpored ukrepov, ki jih predlaga vlagatelj;
(eb) a substitution plan, including research and development and a timetable for proposed actions by the applicant.
(c) utemeljitev, zakaj niso upoštevana tveganja za zdravje ljudi in okolje, ki izhajajo iz:
(c) a justification for not considering risks to human health and the environment arising either from:
Vloga lahko vključuje tudi utemeljitev, zakaj niso upoštevana tveganja za zdravje ljudi in okolje, ki izhajajo iz:
The application may also include a justification for not considering risks to human health and the environment arising either from:
(i) emisij snovi iz naprave, za katero je bilo izdano dovoljenje v skladu z Direktivo 96/61/ES; ali
(i) emissions of a substance from an installation for which a permit was granted in accordance with Directive 96/61/EC; or
(ii) izpustov snovi iz točkovnega vira, za katere veljata zahteva za predhodno ureditev iz člena 11(3)(g) Direktive 2000/60/ES in zakonodaja, sprejeta v skladu s členom 16 navedene direktive.
(ii) discharges of a substance from a point source governed by the requirement for prior regulation referred to in Article 11(3)(g) of Directive 2000/60/EC and legislation adopted under Article 16 of that Directive.
(Predlog spremembe 241 (spremenjen) – prva obravnava)
(Amendment 241 (revised) - first reading)
Socialno-ekonomske analize in načrt nadomestitve morajo biti vključeni v vlogo za odobritev.
The socio-economic analyses and the substitution plan must be included in the application for authorisation.
Če je bila za uporabo snovi že oddana vloga, se lahko naknadni vlagatelj sklicuje na sestavne dele predhodne vloge, predložene v skladu s členom 61(4)(d) in (5)(a) in (b) , pod pogojem, da ima kasnejši vlagatelj privoljenje prejšnjega vlagatelja, da se sklicuje na te dele vloge.
If an application has been made for a use of a substance, a subsequent applicant may refer to the parts of the previous application submitted in accordance with Article 61(4)(d) and (5)(a) and (b) , provided that the subsequent applicant has permission from the previous applicant to refer to these parts of the application.
Če je bila za uporabo snovi že oddana vloga, se lahko naknadni vlagatelj sklicuje na sestavne dele predhodne vloge, predložene v skladu s členom 61(4)(d) , (ea) in (eb) , pod pogojem, da ima kasnejši vlagatelj privoljenje prejšnjega vlagatelja, da se sklicuje na te dele vloge.
If an application has been made for a use of a substance, a subsequent applicant may refer to the parts of the previous application submitted in accordance with Article 61(4)(d), (ea) and (eb) , provided that the subsequent applicant has permission from the previous applicant to refer to these parts of the application.
Če je bila za uporabo snovi odobritev že dodeljena, se lahko naknadni vlagatelj sklicuje na sestavne dele predhodne vloge, predložene v skladu s členom 61(4)(d) in (5)(a) in (b) , pod pogojem, da ima kasnejši vlagatelj privoljenje imetnika odobritve, da se sklicuje na te dele vloge.
If an authorisation has been granted for a use of a substance, a subsequent applicant may refer to the parts of the holder’s application submitted in accordance with Article 61(4)(d) and (5)(a) and (b) , provided that the subsequent applicant has permission from the holder of the authorisation to refer to these parts of the application.
Če je bila za uporabo snovi odobritev že dodeljena, se lahko naknadni vlagatelj sklicuje na sestavne dele predhodne vloge, predložene v skladu s členom 61(4)(d) , (ea) in (eb) , pod pogojem, da ima kasnejši vlagatelj privoljenje imetnika odobritve, da se sklicuje na te dele vloge.
If an authorisation has been granted for a use of a substance, a subsequent applicant may refer to the parts of the holder’s application submitted in accordance with Article 61(4)(d), (ea) and (eb) , provided that the subsequent applicant has permission from the holder of the authorisation to refer to these parts of the application.
Povezan s predlogom spremembe člena 61.
Linked to the amendment to Article 61.
Osnutek mnenja vsebuje naslednje elemente:
The draft opinions shall include the following elements:
(a) Odbor za oceno tveganja: oceno tveganja za zdravje ljudi in/ali okolje, ki izhaja iz uporabe (uporab) snovi, kot je (so) opisana(-e) v vlogi, in če je ustrezno, oceno tveganj, ki izhajajo iz morebitnih alternativ;
(a) Committee for Risk Assessment: an assessment of the risk to human health and/or the environment arising from the use(s) of the substance as described in the application and , if relevant, an assessment of the risks arising from possible alternatives;
(a) Odbor za oceno tveganja: oceno tveganja za zdravje ljudi in/ali okolje, ki izhaja iz uporabe (uporab) snovi, kot je (so) opisana(-e) v vlogi, in oceno tveganj, ki izhajajo iz morebitnih alternativ;
(a) Committee for Risk Assessment: an assessment of the risk to human health and/or the environment arising from the use(s) of the substance as described in the application and an assessment of the risks arising from possible alternatives;
(b) Odbor za socialno-ekonomsko analizo: oceno socialno-ekonomskih dejavnikov ter razpoložljivost, primernost in tehnično izvedljivost drugih možnosti, povezanih z uporabo(-ami) snovi, kot je (so) opisana(-e) v vlogi , če se ta predloži v skladu s členom 61(5) .
(b) Committee for Socio-economic Analysis: an assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application , when an application is made in accordance with Article 61(5) .
(b) Odbor za socialno-ekonomsko analizo: oceno socialno-ekonomskih dejavnikov ter razpoložljivost, primernost in tehnično izvedljivost drugih možnosti, povezanih z uporabo(-ami) snovi, kot je (so) opisana(-e) v vlogi.
(b) Committee for Socio-economic Analysis: an assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application.
Komisija pripravi osnutek odločitve o odobritvi v treh mesecih po prejemu mnenj Agencije.
The Commission shall prepare a draft authorisation decision within three months of receipt of the opinions from the Agency.
Dokončna odločitev o izdaji ali zavrnitvi odobritve se sprejme v skladu s postopkom iz člena 132(2) .
A final decision granting or refusing the authorisation shall be taken in accordance with the procedure referred to in Article 132(2) .
Dokončna odločitev o izdaji ali zavrnitvi odobritve se sprejme v skladu s postopkom iz člena 132(3a) .
A final decision granting or refusing the authorisation shall be taken in accordance with the procedure referred to in Article 132(3a) .
Ta predlog spremembe se vloži spričo sodbe Evropskega sodišča C-122/04 z dne 23. februarja 2006 o Uredbi Forest Focus in novega sklepa o „komitologiji“.
This amendment is tabled in light of a judgement by the European Court of Justice of 23 February 2006 C-122/04 on "Forest Focus" and of the new "commitology" Decision.
V svoji sodbi v primeru C-122/04 je Sodišče ugotovilo, da mora Komisija, če želi odstopati od meril za izbiro postopka odbora, to tudi obrazložiti, sicer je predpis lahko razveljavljen.
In its judgement in case C-122/04, the Court of Justice found that the Commission has to justify when it wants to deviate from the criteria for the choice of the committee procedure, otherwise the act can be annulled.
Komisija je brez kakršnekoli obrazložitve predlagala svetovalni postopek za izdajanje odobritve – četudi je takšna odločitev očitno splošne narave (glej člene 55(2), 57(1c) in 61(2) in (3)) in bi zato sodila pod regulativni postopek.
The Commission proposed the advisory procedure for the granting of authorisations without any justification - even though such a decision is clearly of general scope (see Art. 55(2), 57(1c) and 61(2) and (3)), and should therefore have come under the regulatory procedure.
V skladu z novim sklepom o „komitologiji“ bi se moral uporabljati novi „regulativni postopek z nadzorom“.
In accordance with the new "commitology" Decision, the new "regulatory procedure with scrutiny" should apply.
Obveznost imetnikov odobritve
Obligation of holders of authorisations
Obveznost obveščanja o snoveh, za katere je potrebna odobritev
Obligation of information on substances subject to authorisations
Imetniki odobritve kakor tudi uporabniki na nižji stopnji iz člena 55(2), ki vključujejo snovi v pripravke, vključijo številko odobritve v oznako, preden dajo snov ali pripravek, ki snov vsebuje, v promet za dovoljeno uporabo brez poseganja v direktivah 67/548/EGS in 1999/45/ES.
Holders of an authorisation, as well as downstream users referred to in Article 55(2) including the substances in a preparation, shall include the authorisation number on the label before they place the substance or a preparation containing the substance on the market for an authorised use without prejudice to Directive 67/548/EEC and Directive 1999/45/EC.
To se naredi takoj, ko je številka odobritve objavljena v skladu s členom 63(9).
This shall be done without delay once the authorisation number has been made publicly available in accordance with Article 63(9).
Vse snovi, namenjene samostojni uporabi ali uporabi v pripravkih ali v izdelkih, ki izpolnjujejo pogoje iz člena 56, se označijo in se jim vedno priloži varnostni list.
All substances, for use on their own, in preparations or in articles, that fulfil the conditions set out in Article 56 shall be labelled and accompanied, at all times, by a safety data sheet.
Označba vključuje:
The label shall include:
(a) ime snovi,
(a) the name of the substance,
(b) potrdilo, da je snov vključena v Prilogo XIV, in
(b) attestation that the substance is included in Annex XIV, and
(c) vsako posebno uporabo, za katero je bila snov odobrena.
(c) each specific use for which the substance has been authorised.
(Predlog spremembe 246 – prva obravnava)
(Amendment 246 - first reading)
Razumljivejše besedilo.
More comprehensive wording.
Agencija takoj /nemudoma/ na svoji spletni strani objavi obvestilo, da država članica ali Komisija namerava sprožiti postopek za določitev omejitev, in obvesti vse tiste, ki so predložili vlogo za registracijo zadevne snovi.
The Agency shall inform immediately/without delay/ post on its website that a Member State or the Commission intend to instigate a restriction process and shall inform those who posted a registration for the concerned substance.
Ustreza predlogu spremembe 789, sprejetem v prvi obravnavi.
Corresponds to Amendment 789 adopted in First Reading.
Omejitve se lahko uporabljajo brez količinske omejitve, tj. pod 1t/l.
Restrictions may apply without tonnage limit i.e. below 1t/y.
Vse zainteresirane strani imajo pravico vedeti o omejitvenih namerah Agencije ali držav članic.
There is a right to know for all interested parties about the restriction intentions of the Agency or the Member States.
Države članice lahko do …* ohranijo vse obstoječe in strožje omejitve v zvezi s Prilogo XVII glede proizvodnje, dajanja v promet ali uporabe snovi, pod pogojem, da so bile te omejitve priglašene v skladu s Pogodbo.
Until …*, a Member State may maintain any existing and more stringent restrictions in relation to Annex XVII on the manufacture, placing on the market or use of a substance, provided that those restrictions have been notified according to the Treaty.
Komisija do …** izdela in objavi popis teh omejitev.
The Commission shall compile and publish an inventory of these restrictions by …**.
Države članice lahko do …* ohranijo vse obstoječe ali strožje omejitve ter vse ukrepe za njihovo izvrševanje v zvezi s Prilogo XVII glede proizvodnje, dajanja v promet ali uporabe snovi, pod pogojem, da so bile te omejitve priglašene v skladu s Pogodbo.
Until …*, a Member State may maintain any existing or more stringent restrictions as well as any implementing measures thereof in relation to Annex XVII on the manufacture, placing on the market or use of a substance, provided that those restrictions have been notified according to the Treaty.
Omejitve iz Direktive 76/769 se prenesejo v REACH.
The restrictions of Directive 76/769 will be carried over into REACH.
REACH se kot uredba neposredno uporablja v državah članicah.
As a regulation, REACH is directly applicable in the Member States.