natgillin/translations-raw huggingface dataset:
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 (1), Council Directive 93/42/
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 članico aktivnih medicinskih pripomočkih za vsaditev (1), Direktiva Sveta 93/42/EGS z dne 14. junija 1993
(b) the technical and economic feasibility of alternatives for the applicant.
(b) ali so alternative za vlagatelja tehnično in ekonomsko izvedljive.
EEC of 14 June 1993 concerning medical devices (2) or Directive 98/79/EC of the European Parliament and of the Council of
2) in Direktiva 98/79/ES Evrop- o medicinskih pripomočkih ( skega parlamenta in Sveta z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih (3).
(a) 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;
(a) 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;
(b) substances meeting the criteria in Article 57(d) or (e);
(b) snovi, ki izpolnjujejo kriterije iz člena 57(d) ali (e);
Authorisations shall be subject to a timelimited review without prejudice to any decision on a future review period and shall normally be subject to conditions, including monitoring.
Avtorizacije se preverjajo v časovno omejenem roku brez poseganja v odločitve glede prihodnjega obdobja preverjanja; običajno zanje veljajo določeni pogoji, vključno z monitoringom.
The duration of the timelimited review for any authorisation shall be determined on a case-by-case basis taking into account all relevant information including the elements listed in paragraph 4(a) to (d), as appropriate.
Trajanje časovno omejenega preverjanja za kakršno koli avtorizacijo se določi za vsak primer posebej, pri čemer se upoštevajo vse ustrezne informacije, skupaj z dejavniki, navedenimi v odstavku 4(a) do (d), kot je primerno.
(c) substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties.
(c) 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.
(a) the person(s) to whom the authorisation is granted;
(a) oseba(-e), kateri(-m) se dodeli avtorizacija(-e);
(b) the identity of the substance(s);
(b) podatki o snovi(-eh);
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 socioeconomic 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 socialnoekonomske 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 Socioeconomic 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 socialnoekonomsko analizo, navedenih v členu 64(4)(a) in (b):
(d) any conditions under which the authorisation is granted;
(c) uporaba(-e), za katero(e) se dodeli avtorizacija;
(e) the timelimited review period;
(d) pogoji, pod katerimi se dodeli avtorizacija;
(a) the risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed;
(a) tveganja, ki ga pomenijo uporabe snovi, vključno z ustreznostjo in učinkovitostjo predlaganih ukrepov za obvladovanje tveganja;
(f) any monitoring arrangement.
(f) način spremljanja.
(b) the socioeconomic benefits arising from its use and the socioeconomic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;
(b) socialnoekonomskih koristi, ki izhajajo iz njene uporabe, in socialnoekonomskih posledic v primeru zavrnitve avtorizacije, kot jih prikažejo vlagatelj ali druge zainteresirane strani;
(c) 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);
(c) 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);
(d) available information on the risks to human health or the environment of any alternative substances or technologies.
(d) razpoložljivih informacijo tveganjih, ki jih alternativne snovi ali tehnologije pomenijo za zdravje ljudi ali okolje.
(a) whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking
(a) ali bi se s prehodom na alternative zmanjšalo celotno tveganje za zdravje ljudi in okolje, pri čemer se upoštevajo
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 timelimited 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.
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 (1), 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 (1), Komisija prekliče avtorizacijo zato uporabo.
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, daje 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 socioeconomic analysis contained in the original application.
Če imetnik ne more dokazati, daje tveganje pod ustreznim nadzorom, predloži tudi zadnjemu stanju prilagojeno socialnoekonomsko 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 nadzorom, predloži zadnjemu o kemijski varnosti.
(a) the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socioeconomic impact; or for authorisation shall include the
(a) se okoliščine iz prvotne avtorizacije spremenijo tako, da pomenijo tveganje za zdravje ljudi ali okolje ali da imajo socialnoekonomske posledice; ali
(b) new information on possible substitutes becomes available.
(b) postanejo dostopne nove informacije glede morebitnih alternativ.
(a) the identity of the substance(s), as referred to in Section 2 of Annex VI;
(a) identiteto snovi v skladu z oddelkom 2 Priloge VI;
(b) the name and contact details of the person or persons making the application;
(b) ime in podatke osebe ali oseb za stike, ki oddajo vlogo;
(c) 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;
(c) 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;
(d) 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;
(d) 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;
(e) 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;
(e) 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;
(f) 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.
(f) 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).
(a) a socioeconomic analysis conducted in accordance with Annex XVI;
(a) socialnoekonomsko analizo, izvedeno v skladu s Prilogo XVI;
The Agency's Committees for Risk Assessment and Socioeconomic 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 socialnoekonomsko analizo pripravita osnutek svojega mnenja v desetih mesecih po datumu prejema vloge.
(b) 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.
The Agency shall make available on its website broad information on uses, taking into account Articles 118 and 119 on access to information, for which applications have been received and for reviews of authorisations, with a deadline by which information on alternative substances or technologies may be submitted by interested third parties.
Ob upoštevanju členov 118 in 119 o dostopu do informacij da Agencija na razpolago na svoji spletni strani splošne informacije o uporabah, za katere je prejela vloge ter za preverjanje avtorizacij, pri čemer navede roke, do katerih zainteresirane tretje strani lahko predložijo informacije o alternativnih snoveh ali tehnologijah.
The Committee for Socioeconomic Analysis may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time period, additional information on possible alternative substances or technologies.
Odbor za socialnoekonomsko analizo lahko, če meni, daje to potrebno, od vlagatelja ali tretjih strani zahteva, da v določenem roku predloži dodatne informacije o alternativnih snoveh ali tehnologijah.
(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, including the appropriateness and effectiveness of the risk management measures 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 skupaj z ustreznostjo in učinkovitostjo ukrepov za obvladovanje tveganja, kot je (so) opisana(-e) v vlogi, in če je ustrezno, oceno tveganj, ki izhajajo iz morebitnih alternativ;
(b) Committee for Socioeconomic Analysis: an assessment of the socioeconomic 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 62 and of any third party contributions submitted under paragraph 2 of this Article.
(b) Odbor za socialnoekonomsko analizo: oceno socialnoekonomskih 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 62, ali vseh prispevkov zainteresiranih tretjih strani iz odstavka 2 tega člena.
The draft opinion shall be deemed to have been received seven days after the Agency has sent it.
Osnutek mnenja se šteje kot prejet sedem dni potem, ko ga je Agencija poslala.
If the applicant does not wish to comment, the Agency shall send these opinions to the Commission, the Member States and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt of notice from the applicant that he does not intend to comment.
Če vlagatelj ne želi predložiti pripomb, Agencija ti mnenji pošlje Komisiji, državam članicam in vlagatelju v 15 dneh po poteku roka, v katerem lahko vlagatelj predloži pripombe, ali v 15 dneh po prejemu obvestila vlagatelja, dane namerava predložiti pripomb.
The Agency shall determine in accordance with Articles 118 and 119 which parts of its opinions and parts of any attachments thereto should be made publicly available on its website.
V primerih iz člena 63(1) Agencija obravnava vloge skupaj, če se lahko izpolnijo roki za prvo vlogo.
A substance on its own, in a preparation or in an article, for which Annex XVII contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction.
Snov kot taka, v pripravku ali izdelku, za katero vsebuje Priloga XVII omejitev, se ne sme proizvajati, dajati v promet ali uporabljati, čene izpolnjuje pogojev iz te omejitve.
This shall not apply to the manufacture, placing on the market or use of a substance in scientific research and development.
Tone velja za proizvodnjo, dajanje v promet ali uporabo snovi za znanstvene raziskave in razvoj.
Restrictions process
POGLAVJE 2
Any such decision shall take into account the socioeconomic impact of the restriction, including the availability of alternatives.
Nadaljnji uporabniki, ki uporabljajo snov v skladu s členom 56(2), o tem obvestijo Agencijo v treh mesecih po prvi dostavi snovi.
Downstream users using a substance in accordance with Article 56(2) shall notify the Agency within three months of the first supply of the substance.
Če iz proizvodnje snovi, njene uporabe ali dajanja v promet izhaja nesprejemljivo tveganje za zdravje ljudi ali okolje, ki jo je treba obravnavati v celi Skupnosti, se Priloga XVII spremeni v skladu s postopkom iz člena 133(4), tako da se sprejmejo nove omejitve ali spremenijo veljavne omejitve iz Priloge XVII za proizvodnjo, uporabo ali dajanje v promet snovi kot take, v pripravkih ali izdelkih v skladu s postopkom iz členov 69 do 73.
The Committee for Risk Assessment and the Committee for Socioeconomic Analysis shall check whether the dossier submitted conforms to the requirements of Annex XV.
Odbor za oceno tveganja in Odbor za socialnoekonomsko analizo preverita, ali je predložena dokumentacija v skladu z zahtevami iz Priloge XV.
The Agency shall publish without delay the intention of the Commission or of a Member State to instigate a restriction procedure for a substance and shall inform those who submitted a registration for that substance.
Agencija takoj objavi, da namerava Komisija ali država članica sprožiti postopek za omejitev snovi, ter obvesti tiste, ki so predložili registracijo zato snov.
After the date referred to in Article 58(1)(c)(i) for a substance listed in Annex XIV, the Agency shall consider whether the use of that substance in articles poses a risk to human health or the environment that is not adequately controlled. If the Agency considers that the risk is not adequately controlled, it shall prepare a dossier which conforms to the requirements of Annex XV.
Če po mnenju Komisije pomeni proizvodnja, dajanje v promet ali uporaba snovi kot take, v pripravku ali izdelku tveganje za zdravje ljudi ali okolje, ki ni ustrezno nadzorovano in bi ga bilo treba obravnavati, Komisija zaprosi Agencijo, da pripravi dokumentacijo, ki je v skladu z zahtevami iz Priloge XV.
Within 12 months of the receipt of the request from the Commission in paragraph 1 and if this dossier demonstrates that action on a Communitywide basis is necessary, beyond any measures already in place, the Agency shall suggest restrictions, in order to initiate the restrictions process.
V 12 mesecih po prejemu zahteve Komisije v odstavku 1 in če se s to dokumentacijo dokaže, daje tveganje nesprejemljivo in daje zato treba poleg že uvedenih ukrepov sprejeti ukrepe naravni celotne Skupnosti, Agencija predlaga omejitve, da sproži postopek za določitev omejitev.
Without prejudice to Articles 118 and 119, the Agency shall make publicly available on its website all dossiers conforming with Annex XV including the restrictions suggested pursuant to paragraphs 3 and 4 of this Article without delay, clearly indicating the date of publication.
Agencija brez poseganja v člena 118 in 119 v so dokumentacijo, ki je v skladu s Prilogo XV, vključno z omejitvami, predlaganimi v skladu z odstavkoma 3 in 4 tega člena, takoj objavi na svoji spletni strani in pri tem jasno navede datum objave.
(a) comments on dossiers and the suggested restrictions;
(a) pripombe k dokumentaciji in predlaganim omejitvam;
(b) a socioeconomic analysis, or information which can contribute to one, of the suggested restrictions, examining the advantages and drawbacks of the proposed restrictions.
(b) socialnoekonomsko analizo predlaganih omejitev ali informacije, ki se lahko uporabijo za takšno analizo, s katero se preučijo prednosti in slabosti predlaganih omejitev.
If this dossier demonstrates that action on a Communitywide basis is necessary, beyond any measures already in place, the Member State shall submit it to the Agency in the format outlined in Annex XV, in order to initiate the restrictions process.
Če se s to dokumentacijo dokaže, daje treba poleg že uvedenih ukrepov sprejeti ukrepe naravni celotne Skupnosti, država članica to dokumentacijo predloži Agenciji v obliki iz Priloge XV, da sproži postopek za določitev omejitev.
If the conditions laid down in Article 68 are fulfilled, the Commission shall prepare a draft amendment to Annex XVII, within three months of receipt of the opinion of the Committee for Socioeconomic Analysis or by the end of the deadline established under Article 71 if that Committee does not for man opinion, whichever is the earlier.
Če so izpolnjeni pogoji iz člena 68, Komisija pripravi osnutek spremembe Priloge XVII v treh mesecih po prejemu mnenja Odbora za socialnoekonomsko analizo ali do konca roka, določenega v skladu s členom 71, če ta odbor ne sprejme mnenja, kar nastopi prej.
Agency opinion: Committee for Socioeconomic Analysis
Mnenje Agencije: Odbor za socialnoekonomsko analizo
Where the draft amendment diverges from the original proposal or if it does not take the opinions from the Agency into account, the Commission shall annex a detailed explanation of the reasons for the differences.
Če osnutek spremembe odstopa od izvirnega predloga ali čene upošteva mnenj Agencije, Komisija priloži podrobno utemeljitev razlogov za neskladja.
Within 12 months of the date of publication referred to in Article 69(6), the Committee for Socioeconomic Analysis shall formulate an opinion on the suggested restrictions, based on its consideration of the relevant parts of the dossier and the socioeconomic impact.
V dvanajstih mesecih po datumu objave iz člena 69(6) Odbor za socialnoekonomsko analizo na podlagi preučitve ustreznih delov dokumentacije in socialno-ekonomskega vpliva oblikuje mnenje o predlaganih omejitvah.
It shall prepare a draft opinion on the suggested restrictions and on the related socioeconomic impact, taking account of the analyses or information according to Article 69(6)(b), if there are any.
Pripravi osnutek mnenja o predlaganih omejitvah in njihovem socialnoekonomske m vplivu, pri čemer upošteva analize ali informacije v skladu s točko (b) člena 69(6), če so bile predložene.
Where the opinion of the Committee for Risk Assessment diverges significantly from the restrictions suggested, the Agency may postpone the deadline for the opinion of the Committee for Socioeconomic Analysis by a maximum of 90 days.
Če mnenje Odbora za oceno tveganja bistveno odstopa od predlaganih omejitev, lahko Agencija rok za sprejetje mnenja Odbora za socialnoekonomsko analizo podaljša za največ 90 dni.
L 136/53 any other questions that arise from the operation of this Regulation relating to the socioeconomic impact of possible legislative action on substances;
L 136/53 uporabe te uredbe v zvezi s socialno-ekonomskim vplivom možnih zakonodajnih ukrepov na snovi;
(e) a Member State Committee, which shall be responsible for resolving potential divergences of opinions on draft decisions proposed by the Agency or the Member States under Title VI and proposals for identification of substances of very high concern to be subjected to the authorisation procedure under Title VII;
V členu 11(4) se pri sestavi in znesku pristojbin upošteva, ali so bile informacije predložene skupaj ali ločeno.
In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately.
(e) Odbor držav članic, ki je odgovoren za odpravo morebitnih neskladij v mnenjih o osnutkih odločitev, ki jih predlagajo Agencija ali države članice v skladu z naslovom VI, ter predlogih za identifikacijo snovi, ki vzbujajo veliko zaskrbljenost, za katere mora veljati postopek za dodelitev avtorizacije v skladu z naslovom VII;
(f) a Forum for Exchange of Information on Enforcement (hereinafter referred to as the Forum) which shall coordinate a network of Member States authorities responsible for enforcement of this Regulation;
(f) forum za izmenjavo informacijo izvrševanju (v nadaljevanju „forum“), ki usklajuje mrežo organov držav članic, odgovornih za izvrševanje te uredbe;
(g) a Secretariat, which shall work under the leadership of the Executive Director and provide technical, scientific and administrative support for the Committees and the Forum and ensure appropriate coordination between them.
(g) sekretariat, ki deluje pod vodstvom izvršnega direktorja in zagotavlja tehnično, znanstveno in upravno podporo obema odboroma in forumu ter ustrezno medsebojno usklajevanje.