natgillin/translations-raw huggingface dataset:
Within 60 days of circulation, the other Member States or the Agency may comment on the identification of the substance in relation to the criteria in Article 57 in the dossier to the Agency.
V 60 dneh po tem, ko je bila dokumentacija razposlana, lahko druge države članice ali Agencija v dokumentaciji predložijo pripombe v zvezi z dokumentacijo snovi glede na kriterije iz člena 57.
If the Agency does not receive or make any comments, it shall include this substance on the list referred to in paragraph 1.
Če Agencija ne prejme ali ne da nobenih pripomb, to snov vključi na seznam iz odstavka 1.
The Agency may include this substance in its recommendations under Article 58(3).
Agencija lahko to snov vključi v svoja priporočila v skladu s členom 58(3).
When comments are made or received, the Agency shall refer the dossier to the Member State Committee within 15 days of the end of the 60-day period referred to in paragraph 5.
Po tem, ko so pripombe podane ali prejete, Agencija predloži dokumentacijo Odboru držav članic v 15 dneh po poteku 60-dnevnega roka iz odstavka 5.
If, within 30 days of the referral, the Member State Committee reaches a unanimous agreement on the identification, the Agency shall include the substance in the list referred to in paragraph 1.
Če Odbor držav članic v 30 dneh po prejemu dokumentacije doseže soglasje o identifikaciji, vključi Agencija to snov v seznam iz odstavka 1.
The Agency may include that substance in its recommendations under Article 58(3).
Agencija lahko to snov vključi v svoja priporočila v skladu s členom 58(3).
If the Member State Committee fails to reach a unanimous agreement, the Commission shall prepare a draft proposal on the identification of the substance within three months of receipt of the opinion of the Member State Committee.
Če Odbor držav članic soglasja ne doseže, Komisija v 3 mesecih po prejemu mnenja Odbora držav članic pripravi osnutek predloga o identifikaciji snovi.
A final decision on the identification of the substance shall be taken in accordance with the procedure referred to in Article 133(3).
Končna odločitev o identifikaciji snovi se sprejme v skladu s postopkom iz člena 133(3).
The Agency shall publish and update the list referred to in paragraph 1 on its website without delay after a decision on inclusion of a substance has been taken.
Agencija objavi in posodobi seznam iz odstavka 1 na svoji spletni strani takoj, ko je odločitev o vključitvi snovi sprejeta.
Granting of authorisations
Dodelitev avtorizacije
The Commission shall be responsible for taking decisions on applications for authorisations in accordance with this Title.
Komisija je pristojna, da odloča o vlogah za avtorizacijo, v skladu s tem naslovom.
Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with Section 6.4 of Annex I and as documented in the applicant's chemical safety report, taking into account the opinion of the Committee for Risk Assessment referred to in Article 64(4)(a).
Avtorizacija se brez poseganja v odstavek 3 dodeli, če je tveganje za zdravje ljudi ali okolje, ki izhaja iz uporabe snovi zaradi njenih intrinzičnih lastnosti iz Priloge XIV, pod ustreznim nadzorom v skladu z oddelkom 6.4 Priloge I, kar vlagatelj dokumentira s poročilom o kemijski varnosti, pri čemer se upošteva mnenje Odbora za oceno tveganja iz člena 64(4)(a).
When granting the authorisation, and in any conditions imposed therein, the Commission shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision.
Pri dodelitvi avtorizacije in v vseh z avtorizacijo povezanih pogojih, Komisija upošteva vse informacije o izpustih, emisijah in izgubah, vključno s tveganji, ki izhajajo iz razširjene ali razpršene uporabe, ki so znane v času odločitve.
The Commission shall not consider the risks to human health arising from the use of a substance in a medical device regulated by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices [48], Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [49] or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [50].
Komisija ne upošteva tveganj za zdravje ljudi, ki izhajajo iz uporabe snovi v medicinskem pripomočku in jih urejajo Direktiva Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev [48], Direktiva Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih [49] in Direktiva 98/79/ES Evropskega parlamenta in Sveta z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih [50].
Paragraph 2 shall not apply to:
Odstavek 2 se ne uporablja za:
substances meeting the criteria in Article 57(a), (b), (c) or (f) for which it is not possible to determine a threshold in accordance with Section 6.4 of Annex I;
snovi, ki izpolnjujejo kriterije iz člena 57(a), (b), (c) ali (f), za katere ni mogoče določiti praga v skladu z oddelkom 6.4 Priloge I;
substances meeting the criteria in Article 57(d) or (e);
snovi, ki izpolnjujejo kriterije iz člena 57(d) ali (e);
substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties.
snovi, navedene v členu 57(f), ki so po svojih lastnostih obstojne, se kopičijo v organizmih in so strupene ali zelo obstojne in se zelo lahko kopičijo v organizmih.
If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies.
Če se avtorizacija ne more dodeliti v skladu z odstavkom 2 ali se ne more izdati za snovi, navedene v odstavku 3, se lahko kljub temu dodeli samo, če se dokaže, da socialno-ekonomske koristi prevladajo nad tveganjem za zdravje ljudi ali okolje, ki izhaja iz uporabe snovi, ter če niso na voljo ustrezne alternativne snovi ali tehnologije.
This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis referred to in Article 64(4)(a) and (b):
Odločitev se sprejme po preučitvi vseh naslednjih dejavnikov in ob upoštevanju mnenj Odbora za oceno tveganja in Odbora za socialno-ekonomsko analizo, navedenih v členu 64(4)(a) in (b):
the risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed;
tveganja, ki ga pomenijo uporabe snovi, vključno z ustreznostjo in učinkovitostjo predlaganih ukrepov za obvladovanje tveganja;
the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;
socialno-ekonomskih koristi, ki izhajajo iz njene uporabe, in socialno-ekonomskih posledic v primeru zavrnitve avtorizacije, kot jih prikažejo vlagatelj ali druge zainteresirane strani;
the analysis of the alternatives submitted by the applicant under Article 62(4)(e) or any substitution plan submitted by the applicant under Article 62(4)(f), and any third party contributions submitted under Article 64(2);
analize alternative, ki jo predloži vlagatelj v skladu s členom 62(4)(e), ali načrta nadomestitve, ki ga predloži vlagatelj v skladu s členom 62(4)(f), in prispevkov tretje strani, predloženih v skladu s členom 64(2);
available information on the risks to human health or the environment of any alternative substances or technologies.
razpoložljivih informacij o tveganjih, ki jih alternativne snovi ali tehnologije pomenijo za zdravje ljudi ali okolje.
When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the Commission, including:
Komisija pri ocenjevanju, ali so na voljo ustrezne alternativne snovi ali tehnologije, upošteva vse ustrezne vidike, skupaj z naslednjim:
whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures;
ali bi se s prehodom na alternative zmanjšalo celotno tveganje za zdravje ljudi in okolje, pri čemer se upoštevajo ustreznost in učinkovitost ukrepov za obvladovanje tveganja;
the technical and economic feasibility of alternatives for the applicant.
ali so alternative za vlagatelja tehnično in ekonomsko izvedljive.
A use shall not be authorised if this would constitute a relaxation of a restriction set out in Annex XVII.
Uporaba se ne dovoli, če bi to pomenilo sprostitev omejitve iz Priloge XVII.
An authorisation shall be granted only if the application is made in conformity with the requirements of Article 62.
Avtorizacija se dodeli samo, če je bila vloga predložena v skladu z zahtevami iz člena 62.
The authorisation shall specify:
V avtorizaciji morajo biti navedeni naslednji podatki:
the person(s) to whom the authorisation is granted;
oseba(-e), kateri(-m) se dodeli avtorizacija(-e);
the identity of the substance(s);
podatki o snovi(-eh);
the use(s) for which the authorisation is granted;
uporaba(-e), za katero(-e) se dodeli avtorizacija;
any conditions under which the authorisation is granted;
pogoji, pod katerimi se dodeli avtorizacija;
the time-limited review period;
časovno omejen rok za preverjanje;
any monitoring arrangement.
način spremljanja.
Notwithstanding any conditions of an authorisation, the holder shall ensure that the exposure is reduced to as low a level as is technically and practically possible.
Ne glede na pogoje iz avtorizacije imetnik zagotovi, da se izpostavljenost zniža do najnižje ravni, ki jo je tehnično in praktično možno doseči.
Review of authorisations
Preverjanje avtorizacij
Authorisations granted in accordance with Article 60 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.
Avtorizacije, dodeljene v skladu s členom 60, veljajo, dokler se Komisija ne odloči, da v okviru preverjanja avtorizacije spremeni ali umakne, če imetnik avtorizacije predloži oceno o preverjanju vsaj 18 mesecev pred potekom časovno omejenega roka za preverjanje.
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.
Namesto ponovne predložitve vseh sestavnih delov prvotne vloge za trenutno veljavno avtorizacijo lahko imetnik avtorizacije predloži samo številko trenutno veljavne avtorizacije, ob upoštevanju drugega, tretjega in četrtega pododstavka.
A holder of an authorisation granted in accordance with Article 60 shall submit an update of the analysis of alternatives referred to in Article 62(4)(e), including information about any relevant research and development activities by the applicant, if appropriate, and any substitution plan submitted under Article 62(4)(f).
Imetnik avtorizacije, izdane v skladu s členom 60, predloži posodobljeno analizo alternativ iz člena 62(4)(e), vključno z informacijami o ustreznih raziskovalnih in razvojnih dejavnostih vlagatelja, če je to ustrezno, in načrt nadomestitve, predložen v skladu s členom 62(4)(f).
If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant.
Če je iz posodobljene analize alternativ razvidno, da je na voljo ustrezna alternativa, pri čemer se upoštevajo dejavniki iz člena 60(5), predloži načrt nadomestitve, skupaj s časovnim razporedom ukrepov, ki jih predlaga vlagatelj.
If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic analysis contained in the original application.
Če imetnik ne more dokazati, da je tveganje pod ustreznim nadzorom, predloži tudi zadnjemu stanju prilagojeno socialno-ekonomsko analizo iz prvotne vloge.
If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report.
Če potem lahko dokaže, da je tveganje pod ustreznim nadzorom, predloži zadnjemu stanju prilagojeno poročilo o kemijski varnosti.
If any other elements of the original application have changed, he shall also submit updates of these element(s).
Če se spremenijo drugi sestavni deli prvotne vloge, predloži tudi te, ki jih prilagodi zadnjemu stanju.
When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorisation in the context of the review shall be taken in accordance with the procedure referred to in Article 64 applied mutatis mutandis.
Če se v skladu s tem odstavkom predloži kaka posodobljena informacija, se vse odločitve o spremembi ali preklicu avtorizacije v okviru preverjanja sprejmejo v skladu s postopkom iz člena 64, ki se uporablja smiselno.
Authorisations may be reviewed at any time if:
Avtorizacija se lahko preveri kadar koli, če:
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
se okoliščine iz prvotne avtorizacije spremenijo tako, da pomenijo tveganje za zdravje ljudi ali okolje ali da imajo socialno-ekonomske posledice; ali
new information on possible substitutes becomes available.
postanejo dostopne nove informacije glede morebitnih alternativ.
The Commission shall set a reasonable deadline by which the holder(s) of the authorisation may submit further information necessary for the review and indicate by when it will take a decision in accordance with Article 64.
Komisija določi ustrezen rok, do katerega imetnik(-i) avtorizacije lahko predloži(-jo) dodatne informacije, potrebne za preverjanje, ter pri tem navede, do kdaj bo sprejela odločitev v skladu s členom 64.
In its review decision the Commission may, if circumstances have changed and taking into account the principle of proportionality, amend or withdraw the authorisation, if under the changed circumstances it would not have been granted or if suitable alternatives in accordance with Article 60(5) become available.
V svoji odločitvi o preverjanju lahko Komisija, če so se spremenile okoliščine in ob upoštevanju načela sorazmernosti, avtorizacije spremeni ali prekliče z datumom odločitve, če zaradi spremenjenih okoliščin ne bi bila dodeljena ali če so na voljo ustrezne alternative v skladu s členom 60(5).
In the latter case the Commission shall require the holder of the authorisation to present a substitution plan if he has not already done so as part of his application or update.
V tem primeru Komisija od imetnika avtorizacije zahteva predložitev načrta nadomestitve, če tega še ni storil v okviru svoje vloge ali posodobitve.
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 resno in neposredno ogroženo zdravje ljudi ali okolje, lahko Komisija avtorizacijo ob upoštevanju načela sorazmernosti začasno prekliče, dokler traja preverjanje.
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 lahko preverijo avtorizacije, dodeljene za uporabo zadevne snovi.
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 lahko preverijo avtorizacije, dodeljene za uporabo zadevne snovi v ustreznem porečju.
If a use of a substance is subsequently prohibited or otherwise restricted in Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants [51], the Commission shall withdraw the authorisation for that use.
Če se uporaba snovi pozneje prepove ali kako drugače omeji v Uredbi (ES) št. 850/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o obstojnih organskih onesnaževalih [51], Komisija prekliče avtorizacijo za to uporabo.
Applications for authorisations
Vloge za avtorizacijo
An application for an authorisation shall be made to the Agency.
Vloga za avtorizacijo se predloži Agenciji.
Applications for authorisation may be made by the manufacturer(s), importer(s) and/or downstream user(s) of the substance.
Vloge za avtorizacijo lahko predložijo proizvajalec(-ci), uvoznik(-i) in/ali nadaljnji uporabnik(-i) snovi.
Applications may be made by one or several persons.
Vlogo lahko predloži ena ali več oseb.
Applications may be made for one or several substances, that meet the definition of a group of substances in Section 1.5 of Annex XI, and for one or several uses.
Vloge se lahko predložijo za eno ali več snovi, ki ustrezajo opredelitvi skupine snovi v oddelku 1.5 Priloge XI, in za eno ali več uporab.
Applications may be made for the applicant's own use(s) and/or for uses for which he intends to place the substance on the market.
Vloge se lahko predložijo za lastno uporabo(-e) vlagatelja(-ev) in/ali uporabe, za katere ta namerava dajati snov v promet.
An application for authorisation shall include the following information:
Vloga za avtorizacijo mora vsebovati naslednje informacije:
the identity of the substance(s), as referred to in Section 2 of Annex VI;
identiteto snovi v skladu z oddelkom 2 Priloge VI;
the name and contact details of the person or persons making the application;
ime in podatke osebe ali oseb za stike, ki oddajo vlogo;
a request for authorisation, specifying for which use(s) the authorisation is sought and covering the use of the substance in preparations and/or the incorporation of the substance in articles, where this is relevant;
zahtevek za avtorizacijo, v katerem se navede, za katero(-e) uporabo(-e) se skuša pridobiti avtorizacijo, in zajame uporabo snovi v pripravkih in/ali vgraditev snovi v izdelke, če je ustrezno;
unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV;
če še ni bilo predloženo v okviru registracije, poročilo o kemijski varnosti v skladu s Prilogo I, v katerem so obravnavana tveganja za zdravje ljudi in/ali okolje, ki izhajajo iz uporabe snovi zaradi intrinzičnih lastnosti, navedenih v Prilogi XIV;
an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate information about any relevant research and development activities by the applicant;
analizo alternativ, ob upoštevanju z njimi povezanih tveganj ter tehnične in ekonomske izvedljivosti nadomestitve, skupaj z informacijami o ustreznih raziskovalnih in razvojnih dejavnostih vlagatelja, če je to ustrezno;
where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for proposed actions by the applicant.
načrt nadomestitve, skupaj s časovnim razporedom ukrepov, ki jih predlaga vlagatelj, če je iz analize alternativ iz točke (e) razvidno, da so na voljo ustrezne alternative, pri čemer se upoštevajo dejavniki iz člena 60(5).
The application may include:
Vloga lahko vključuje:
a socio-economic analysis conducted in accordance with Annex XVI;
socialno-ekonomsko analizo, izvedeno v skladu s Prilogo XVI;
a justification for not considering risks to human health and the environment arising either from:
utemeljitev, zakaj niso upoštevana tveganja za zdravje ljudi in okolje, ki izhajajo iz:
emissions of a substance from an installation for which a permit was granted in accordance with Directive 96/61/EC; or
emisij snovi iz naprave, za katero je bilo izdano dovoljenje v skladu z Direktivo 96/61/ES; ali
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.
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.
The application shall not include the risks to human health arising from the use of a substance in a medical device regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC.
Vloga ne vključuje tveganj za zdravje ljudi, ki izhajajo iz uporabe snovi v medicinskem pripomočku, ki jo urejajo direktive 90/385/EGS, 93/42/EGS in 98/79/ES.
An application for an authorisation shall be accompanied by the fee required in accordance with Title IX.
Ob predložitvi avtorizacije se plača pristojbina v skladu z naslovom IX.
Subsequent applications for authorisation
Naknadne vloge za dodelitev avtorizacije
If an application has been made for a use of a substance, a subsequent applicant may refer to the appropriate parts of the previous application submitted in accordance with Article 62(4)(d), (e) and (f) and (5)(a), 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 ustrezne dele predhodne vloge, predložene v skladu s členom 62(4)(d), (e) in (f) ter (5)(a), pod pogojem, da ima kasnejši vlagatelj privoljenje prejšnjega vlagatelja, 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 appropriate parts of the previous application submitted in accordance with Article 62(4)(d), (e) and (f) and (5)(a), 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 avtorizacija že dodeljena, se lahko naknadni vlagatelj sklicuje na ustrezne dele predhodne vloge, predložene v skladu s členom 62(4)(d), (e) in (f) ter (5)(a), pod pogojem, da ima kasnejši vlagatelj privoljenje imetnika avtorizacije, da se sklicuje na te dele vloge.
Before referring to any previous application in accordance with paragraphs 1 and 2, the subsequent applicant shall update the information of the original application as necessary.
Pred sklicevanjem na predhodno vlogo v skladu z odstavkoma 1 in 2 naknadni vlagatelj ustrezno posodobi informacije v prvotni vlogi.
Procedure for authorisation decisions
Postopek za sprejetje odločitev o avtorizaciji
The Agency shall acknowledge the date of receipt of the application.
Agencija potrdi datum prejema vloge.
The Agency's Committees for Risk Assessment and Socio-economic Analysis shall give their draft opinions within ten months of the date of receipt of the application.
Odbor Agencije za oceno tveganja in Odbor Agencije za socialno-ekonomsko analizo pripravita osnutek svojega mnenja v desetih mesecih po datumu prejema vloge.