natgillin/translations-raw huggingface dataset:
V 30 dneh po koncu postopka vse ostale države članice izdajo dovoljenje za biocidni proizvod v skladu z dogovorjenim povzetkom značilnosti biocidnega proizvoda.
Within 30 days of closure of the procedure, each of the remaining Member States concerned shall authorise the biocidal product in conformity with the agreed summary of biocidal product characteristics.
Člen 36 – odstavka 1 in 2
Article 36 – paragraphs 1 and 2
Z odstopanjem od člena 31(2) lahko katera koli od zadevnih držav članic predlaga, da se zavrne izdaja dovoljenja ali prilagodijo določila in pogoji za dovoljenje, ki bo izdano, pod pogojem, da je tak ukrep utemeljen z naslednjimi razlogi:
By way of derogation from Article 31(2), any of the Member States concerned may propose to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted, provided that such a measure can be justified on grounds of:
Z odstopanjem od člena 31(2) lahko katera koli od zadevnih držav članic zavrne izdajo dovoljenja ali prilagodi določila in pogoje za dovoljenje, ki bo izdano, pod pogojem, da je tak ukrep utemeljen z naslednjimi razlogi:
By way of derogation from Article 31(2), any of the Member States concerned may refuse to grant an authorisation or adjust the terms and conditions of the authorisation to be granted, provided that such a measure can be justified on grounds of:
(a) varstvo okolja;
(a) the protection of the environment;
(b) javni red in javna varnost;
(b) public policy or public security;
(c) varovanje zdravja in življenja ljudi, živali ali rastlin;
(c) the protection of health and life of humans, animals or plants;
(c) varovanje zdravja in življenja ljudi, zlasti ranljivih skupin, ali živali ali rastlin;
(c) the protection of health and life of humans, particularly of vulnerable groups, or of animals or plants;
(d) varstvo nacionalnega bogastva umetniške, zgodovinske ali arheološke vrednosti; ali
(d) the protection of national treasures possessing artistic, historic or archaeological value; or
(e) ciljni organizmi niso prisotni v škodljivih količinah.
(e) the target organisms not being present in harmful quantities.
(ea) izvajanje druge zakonodaje Unije, zlasti Direktive 98/83/ES.
(ea) implementation of other Union legislation, and in particular Directive 98/83/EC.
Katera koli od zadevnih držav članic lahko v skladu s prvim pododstavkom zlasti predlaga, da se zavrne izdaja dovoljenja ali da se prilagodijo določila in pogoji za izdajo dovoljenja za biocidni proizvod, ki vsebuje aktivno snov, za katero se uporablja člen 5(2) ali člen 10(1).
Any of the Member States concerned may, in particular, propose in accordance with the first subparagraph to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted for a biocidal product containing an active substance to which Article 5(2) or 10(1) applies.
Katera koli od zadevnih držav članic lahko v skladu s prvim pododstavkom zlasti zavrne izdajo dovoljenja ali prilagodi določila in pogoje za izdajo dovoljenja za biocidni proizvod, ki vsebuje aktivno snov, za katero se uporablja člen 5(2) ali člen 10(1).
Any of the Member States concerned may, in particular, in accordance with the first subparagraph , refuse to grant an authorisation or adjust the terms and conditions of the authorisation to be granted for a biocidal product containing an active substance to which Article 5(2) or 10(1) applies.
Zadevna država članica vlagatelju pošlje podroben opis razlogov, zaradi katerih je zaprosila za odstopanje na podlagi odstavka 1, in si prizadeva za dosego dogovora z vlagateljem o predlaganem odstopanju.
The Member State concerned shall communicate to the applicant a detailed statement of the grounds for seeking a derogation pursuant to paragraph 1 and shall seek to reach an agreement with the applicant on the proposed derogation.
Če zadevna država članica ne more doseči dogovora z vlagateljem ali če v 60 dneh po poslanem sporočilu od vlagatelja ne prejme odgovora, o tem obvesti Komisijo .
If the Member State concerned is unable to reach agreement with the applicant or receives no reply from the applicant within 60 days of that communication it shall inform the Commission.
Komisija v tem primeru:
In that case, the Commission:
Če zadevna država članica ne more doseči dogovora z vlagateljem ali če v 60 dneh po poslanem sporočilu od vlagatelja ne prejme odgovora, nemudoma obvesti druge države članice in Komisijo o vsaki odločitvi, sprejeti v zvezi s tem , in o njeni utemeljitvi.
If the Member State concerned is unable to reach agreement with the applicant or receives no reply from the applicant within 60 days of that communication it shall without delay inform other Member States and the Commission of any decision taken in this respect and its justification .
(a) lahko zaprosi Agencijo za mnenje o znanstvenih in tehničnih vprašanjih, ki jih je zastavil vlagatelj ali zadevna država članica;
(a) may ask the Agency for an opinion on scientific or technical questions raised by the applicant or the Member State concerned;
(b) sprejme sklep o odstopanju v skladu s postopkom pregleda iz člena 81(3).
(b) shall adopt a decision on the derogation in accordance with the examination procedure referred to in Article 81(3).
Komisija svoj sklep naslovi na zadevno državo članico in Komisija o njej obvesti vlagatelja.
The Commission's decision shall be addressed to the Member State concerned and the Commission shall inform the applicant thereof.
Zadevna država članica v 30 dneh po obvestilu o sklepu Komisije sprejme ukrepe, potrebne za upoštevanje tega sklepa.
The Member State concerned shall take necessary measures to comply with the Commission's decision within 30 days of its notification.
Vlagatelji lahko vložijo vlogo za dovoljenje Unije za biocidne proizvode s podobnimi pogoji uporabe v celotni Uniji in ki sodijo v naslednje kategorije biocidnih proizvodov :
Applicants may apply for Union authorisation for biocidal products which have similar conditions of use across the Union and which fall within the following categories of biocidal products:
Vlagatelji lahko vložijo vlogo za dovoljenje Unije za biocidne proizvode s podobnimi pogoji uporabe v celotni Uniji, razen biocidnih proizvodov, ki vsebujejo aktivne snovi, ki sodijo v člen 5:
Applicants may apply for Union authorisation for biocidal products which have similar conditions of use across the Union with the exception of biocidal products that contain active substances that fall under Article 5 :
(a) biocidne proizvode vrste 6, 7, 9, 10, 12, 13 in 22 ter
(a) biocidal products of product-types 6, 7, 9, 10, 12, 13 and 22; and
a) od leta 2013 se dovoljenje Unije lahko izda za biocidne proizvode, ki vsebujejo eno ali več novih aktivnih snovi;
a) from 2013 the Union authorisation may be granted to biocidal products containing one or more new active substances ;
(b) z učinkom od 1. januarja 2020 vse druge biocidne proizvode razen proizvodov vrste 14, 15, 17, 20 in 21.
(b) with effect from 1 January 2020, all other biocidal products except for those of product-types 14, 15, 17, 20 and 21.
b) od leta 2017 se lahko dovoljenje Unije izda za vse kategorije biocidnih proizvodov.
b) from 2017 the Union authorisation may be granted to all categories of biocidal products .
Komisija Evropskemu parlamentu in Svetu poroča o uporabi tega člena do 31. decembra 2017.
The Commission shall report to the European Parliament and the Council on the application of this Article by 31 December 2017.
Po potrebi poročilu priloži ustrezne predloge za sprejetje v skladu z rednim zakonodajnim postopkom.
It shall, if appropriate, accompany its report with relevant proposals for adoption in accordance with the ordinary legislative procedure.
Komisija najkasneje 31. decembra 2012 sprejme delegirane akte v skladu s členom 82 o opredelitvi „podobnih pogojev uporabe po vsej Uniji“.
No later than 31 December 2012, the Commission shall adopt delegated acts in accordance with Article 82 concerning the definition of "similar conditions of use across the Union ".
Člen 42 – odstavek 3 – pododstavek 2 a (novo)
Article 42 – paragraph 3 – subparagraph 2 a (new)
Potem ko je agencija sprejela vlogo, ocenjevalni pristojni organ čim prej obvesti vlagatelja o pristojbini, ki se plača v skladu s členom 79(2), in zavrne vlogo, če vlagatelj ne plača pristojbine v 30 dneh.
The evaluating competent authority shall, as soon as possible after the Agency has accepted an application, inform the applicant of the fee payable under Article 79(2) and shall reject the application if the applicant fails to pay the fee within 30 days.
Namen je izboljšati skladnost (tako znotraj besedila kot tudi z drugimi deli zakonodaje) ter pojasniti besedilo.
It is intended to improve consistency (both within the text and with other pieces of legislation) and to clarify the text.
Člen 42 – odstavek 4 – pododstavek 3
Article 42 – paragraph 4 – subparagraph 3
Če vlagatelj zahtevanih informacij ne predloži v roku, ocenjevalni pristojni organ vlogo zavrne in vlagatelja o tem ustrezno obvesti.
The evaluating competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.
V takšnih primerih se del pristojbine, plačane v skladu s členom 79(1) in 79(2) , povrne.
In such cases, part of the fee s paid in accordance with Article 79(1) and 79(2) shall be reimbursed.
Člen 42 – odstavek 4 a (novo)
Article 42 – paragraph 4 a (new)
Če je iz registra biocidnih proizvodov razvidno, da pristojni organ preučuje vlogo za isti biocidni proizvod ali je že izdal dovoljenje za isti biocidni proizvod, je ta pristojni organ ocenjevalni pristojni organ.
Where the Register for Biocidal Products shows that a competent authority is examining an application relating to the same biocidal product or has already authorised the same biocidal product, that competent authority shall be the evaluating competent authority.
Ta določba bo pomagala nacionalnim pristojnim organom in vlagateljem prihraniti čas in vire tako, da se bo kolikor je mogoče zmanjšalo podvajanje dela, in tako preprečiti nepotrebno upravno breme in zamude pri dajanju biocidnih proizvodov na trg.
By minimising duplication of work, such provision will help both national competent authorities and applicants save time and resources thereby avoiding any unnecessary administrative burdens or delays in the placing on the market of biocidal products.
Člen 43 – odstavka 3 a (novo) in 4
Article 43 – paragraph 3 a (new) and 4
Agencija v 30 dneh od predložitve mnenja Komisiji v vseh uradnih jezikih Evropske unije posreduje osnutek povzetka značilnosti biocidnega proizvoda, kot je navedeno v členu 21(2), kot je primerno;
Within 30 days of the submission of its opinion to the Commission, the Agency shall transmit, in all the official languages of the European Union, the draft summary of the biocidal product characteristics, as referred to in Article 21(2), as applicable;
Komisija po prejemu mnenja Agencije z izvedbenimi akti sprejme odločitev o dovoljenju Unije za biocidni proizvod .
On receipt of the opinion of the Agency, the Commission shall adopt, by means of implementing acts, a decision on the Union authorisation of the biocidal product.
Komisija po sprejetju odločitve o izdaji dovoljenja Unije nemudoma vnese informacije iz člena 29(4) v register biocidnih proizvodov.
As soon as the Commission has taken a decision to grant a Union authorisation, it shall enter the information referred to in Article 29(4) in the Register for Biocidal Products.
Komisija po prejemu mnenja agencije sprejme odločitev o dovoljenju Unije za biocidni proizvod v skladu s postopkom pregleda iz člena 81(3).
On receipt of the opinion of the Agency, the Commission shall adopt a decision on the Union authorisation of the biocidal product in accordance with the examination procedure referred to in Article 81(3).
Komisija lahko na zahtevo države članice odloči, da bo posebej za ozemlje te države članice prilagodila določene pogoje za dovoljenje Unije ali da odloči, da dovoljenje Unije ne velja na ozemlju te države članice, če se taka zahteva lahko upraviči z enim ali več razlogi iz člena 36(1).
The Commission may, at the request of a Member State , decide to adjust certain conditions of a Union authorisation specifically for the territory of that Member State or decide that a Union authorisation shall not apply in the territory of that Member State, provided that such a request can be justified on one or more of the grounds referred to in Article 36(1).
Država članica obvesti Komisijo, če odloči, da bo posebej za ozemlje te države članice prilagodila določene pogoje za dovoljenje Unije ali če odloči, da dovoljenje Unije ne velja na ozemlju te države članice, če se taka odločitev lahko upraviči z enim ali več razlogi iz člena 36(1).
A Member State shall inform the Commission if it decides to adjust certain conditions of a Union authorisation specifically for the territory of that Member State or decides that a Union authorisation shall not apply in the territory of that Member State, provided that such a decision can be justified on one or more of the grounds referred to in Article 36(1).
Potem ko je Agencija sprejela vlogo, ocenjevalni pristojni organ čim prej obvesti vlagatelja o pristojbini, ki se plača v skladu s členom 79(2), in zavrne vlogo, če vlagatelj ne plača pristojbin v 30 dneh.
The evaluating competent authority shall, as soon as possible after the Agency has accepted the application, inform the applicant of the fee payable under Article 79(2) and shall reject the application if the applicant fails to pay the fees within 30 days.
Člen 45 – odstavek 4 – pododstavek 1
Article 45 – paragraph 4 – subparagraph 1
Ob prejemu mnenja Agencije Komisija sprejme odločitev o podaljšanju ali zavrnitvi podaljšanja dovoljenja Unije v skladu s postopkom pregleda iz člena 81(3).
On receipt of the opinion of the Agency, the Commission shall adopt a decision to renew, or to refuse to renew, the Union authorisation in accordance with the examination procedure referred to in Article 81(3).
Komisija po sprejetju odločitve nemudoma posodobi informacije iz člena 29(4) v registru biocidnih proizvodov.
As soon as the Commission has taken a decision, it shall update the information referred to in Article 29(4) in the Register for Biocidal Products.
Člen 47 – odstavek 1 – točka a
Article 47 – paragraph 1 – point a
(a) pogoji iz člena 18 niso izpolnjeni ;
(a) the conditions referred to in Article 18 are not satisfied;
(a) zahteve iz člena 18 ali, kjer je to pomembno, člena 24 niso izpolnjene ;
(a) the requirements referred to in Article 18 , or, where relevant, in Article 24, are not satisfied;
To je posledica novega člena 24, ki ga je uvedel Svet.
This results from the introduction of the new Article 24 by the Council.
Člen 47 – odstavek 1 – točka a a (novo)
Article 47 – paragraph 1 – point a a (new)
(aa) dovoljenje ni v skladu z zahtevami Direktive 2008/56/ES o določitvi okvira za ukrepe Skupnosti na področju politike morskega okolja, Direktive 2006/118/ES o varstvu podzemne vode pred onesnaževanjem in poslabšanjem, Direktive 2000/60/ES o določitvi okvira za ukrepe Skupnosti na področju vodne politike, Direktive 98/83/ES o kakovosti vode, namenjen za prehrano ljudi in Direktive 2008/1/ES o celovitem preprečevanju in nadzorovanju onesnaževanja;
(aa) the authorisation fails to comply with requirements of Directive 2008/56/EC establishing a framework for community action in the field of marine environmental policy, Directive 2006/118/EC on the protection of groundwater against pollution and deterioration, Directive 2000/60/EC establishing a framework for Community action in the field of water policy, Directive 98/83/EC on groundwater and Directive 2008/1/EC concerning integrated pollution prevention and control;
(Ponovna vložitev predloga spremembe 163 iz prve obravnave.)
(Reinstatement of amendment 163 from first reading.)
Pojasniti je treba, da se dovoljenje prekliče, če ni v skladu z zahtevami zadevne zakonodaje za varstvo voda.
It needs to be clarified that an authorisation shall be cancelled when it fails to comply with the requirements of relevant legislation for the protection of waters.
Ob sprejetju odločitve za preklic ali spremembo dovoljenja pristojni organ ali, v primeru dovoljenja Unije, Komisija v registru biocidnih proizvodov nemudoma posodobi informacije iz člena 29(4) v zvezi z zadevnim biocidnim proizvodom.
As soon as the competent authority or, in the case of a Union authorisation, the Commission, has taken a decision to cancel or amend an authorisation, it shall update the information referred to in Article 29(4) relating to the biocidal product concerned in the Register for Biocidal Products.
Ta člen je odveč, potem ko je Svet spremenil člen 70 tako, da ta sedaj jasno določa, da je register biocidnih proizvodov edini način izmenjave informacij glede uporabe, ter nudi indikacije, kaj naj se vnese v register in kdaj.
Redundancy given that Article 70, as modified by the Council, now makes clear that the Biocidal Products Register is the exclusive means of exchanging information regarding applications and provides indications as to what should be uploaded into the Register and when.
Ob sprejetju odločitve za preklic dovoljenja pristojni organ ali, v primeru dovoljenja Unije, Komisija v registru biocidnih proizvodov posodobi informacije iz člena 29(4) v zvezi z zadevnim biocidnim proizvodom.
As soon as the competent authority or, in the case of a Union authorisation, the Commission, has taken a decision to cancel an authorisation, it shall update the information referred to in Article 29(4) relating to the biocidal product concerned in the Register for Biocidal Products.
Imetnik dovoljenja, ki želi spremeniti informacije, predložene v zvezi s prvotno vlogo za izdajo dovoljenja za proizvod, vloži vlogo pri pristojnih organih ustreznih držav članic, ki so odobrile zadevni biocidni proizvod, ali, v primeru dovoljenja Unije, pri Agenciji.
An authorisation holder seeking to change any of the information submitted in relation to the initial application for authorisation of the product shall apply to the competent authorities of relevant Member States having authorised the biocidal product concerned, or in the case of a Union authorisation, the Agency.
Ti pristojni organi ali, v primeru dovoljenja Unije, Agencija preuči, in Komisija odloči, ali so pogoji iz člena 18 še izpolnjeni in ali je treba spremeniti določila in pogoje za izdajo dovoljenja.
Those competent authorities shall decide, or, in the case of a Union authorisation, the Agency shall examine and the Commission decide whether the conditions of Article 18 are still met and whether the terms and conditions of the authorisation need to be amended.
Ti pristojni organi ali, v primeru dovoljenja Unije, Agencija preuči, in Komisija odloči, ali so pogoji iz člena 18 ali, kjer pomembno, člena 24 še izpolnjeni in ali je treba spremeniti določila in pogoje za izdajo dovoljenja.
Those competent authorities shall decide, or, in the case of a Union authorisation, the Agency shall examine and the Commission decide whether the conditions of Article 18, or, where relevant, Article 24, are still met and whether the terms and conditions of the authorisation need to be amended.
Ob vložitvi vloge se plačajo tudi pristojbine, ki se plačujejo na podlagi člena 79 .
The application shall be accompanied by the fees payable under Article 79.
Ob vložitvi vloge se plačajo tudi pristojbine, ki se plačujejo na podlagi člena 79(1) in 79(2) .
The application shall be accompanied by the fees payable under Article 79(1) and 79(2).
Prav tako bi bilo treba vnesti navzkrižno sklicevanje na nov člen 24, ki ga je uvedel Svet.
There should also be a cross reference to Article 24 which is a new Article introduced by the Council.
Jezik glede plačila pristojbin nacionalnim organom se je spremenil tako, da je skladen z osnutkom člena 79.
The language concerning the payment of fees to the national authorities has been changed to make it consistent with the drafting of Article 79.
Člen 49 – odstavek 2 a (novo)
Article 49 – paragraph 2 a (new)
Sprememba obstoječega dovoljenja spada v eno od naslednjih kategorij sprememb:
An amendment to an existing authorisation shall fall under one of the following categories of changes:
(a) upravna sprememba;
(a) administrative change;
(b) manjša sprememba;
(b) minor change;
(c) večja sprememba.
(c) major change.
Za zagotovitev usklajenega pristopa pri preklicu in spremembi dovoljenj Komisija z izvedbenimi akti določi podrobna pravila za uporabo členov 46 do 49.
In order to ensure a harmonised approach to the cancellation and amendment of authorisations, the Commission shall lay down detailed rules for the application of Articles 46 to 49 by means of implementing acts.
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 81(3).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 81(3) .
Za zagotovitev usklajenega pristopa pri preklicu in spremembi dovoljenj Komisija sprejme delegirane akte v skladu s členom 82, ki določajo podrobna pravila za uporabo členov 46 do 49 , vključno z mehanizmom za reševanje sporov .
In order to ensure a harmonised approach to the cancellation and amendment of authorisations, the Commission shall adopt delegated acts in accordance with Article 82 laying down detailed rules for the application of Articles 46 to 49 , including a dispute settlement mechanism .
To je ukrep splošne uporabe, namenjen za dopolnitev osnovnega akta in bi zato moral biti predmet delegiranih, ne pa izvedbenih aktov.
This is a measure of general application designed to supplement the basic act, and should therefore be subject to delegated, rather than implementing acts.
Člen 52 – odstavek 9
Article 52 – paragraph 9
Kadar se odločitev v zvezi z vlogo za dovoljenje za vzporedno trgovanje sprejme v skladu z določbami tega člena, pristojni organi držav članic, ki so sprejele takšno odločitev, vnesejo informacije iz člena 29(4) v register biocidnih proizvodov.
Where a decision concerning the application for a parallel trade permit is taken in accordance with the provisions of this Article, the competent authorities of Member States which have taken such a decision shall enter the information referred to in Article 29(4) in the Register for Biocidal Products.
Kadar je potrebno, da se ugotovi tehnična ekvivalenca aktivnih snovi, oseba, ki želi ugotoviti zadevno enakovrednost (v nadaljnjem besedilu: vlagatelj), vloži vlogo pri Agenciji in plača ustrezno pristojbino.
Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence ( ‘ the applicant ’ ) shall submit an application to the Agency and pay the applicable fee.
Kadar je potrebno, da se ugotovi tehnična ekvivalenca aktivnih snovi, oseba, ki želi ugotoviti zadevno enakovrednost (v nadaljnjem besedilu: vlagatelj), vloži vlogo v ustrezni obliki pri Agenciji in plača ustrezno pristojbino v skladu s členom 79(1) .
Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence ( " the applicant " ) shall submit an application to the Agency in the correct format and pay the applicable fee in accordance with Article 79(1) .
Pri ocenjevanju tehnične enakovrednosti mora imeti Agencija možnost, da zagotovi vlaganje vlog v pravilnem formatu.
In the assessment of technical equivalence, the Agency should have the possibility to ensure that applications are submitted according to the correct format.
Vloge, ki niso predložene v pravilnem formatu ali zanje ni bila plačana predpisana pristojbina, se zavrnejo.
Applications not submitted according to the format or for which the required fee has not been paid, should be rejected.
Člen 53 – odstavek 2 a (novo)
Article 53 – paragraph 2 a (new)
Če se Agencija odloči, da vloga ni bila predložena v pravilni obliki ali da ni bila plačana ustrezna pristojbina, vlogo zavrne in o tem obvesti vlagatelja.
In the event that the Agency decides that the application has not been submitted in the correct format or that the appropriate fee has not been paid , it shall reject the application and inform the applicant accordingly.