natgillin/translations-raw huggingface dataset:
Navedena pravila za spremembo nebistvenih določb te uredbe z njeno dopolnitvijo se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 72(4).
Those rules , designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).
Za določitev postopkov v zvezi s primerjalnimi ocenami, pri katerih se pojavijo vprašanja v interesu Unije , Komisija prilagodi merila z delegiranimi akti v skladu s členom 71a in pod pogoji iz členov 71b in 71c.
In order to specify the procedures related to comparative assessments involving questions of Union interest, the Commission shall adapt the criteria by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c.
Ne glede na člen 15(4) se dovoljenje za biocidni pripravek, ki vsebuje aktivno snov kot možno snov za zamenjavo, izda za obdobje največ petih let.
Notwithstanding Article 15(4), an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for a period not exceeding five years.
Ne glede na člen 15(4) se dovoljenje za biocidni pripravek, ki vsebuje aktivno snov kot možno snov za zamenjavo, izda za obdobja največ petih let.
Notwithstanding Article 15(4), an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for periods not exceeding five years.
Dokler obstajajo temeljni in učinkoviti biocidni pripravki na osnovi aktivni snovi, ki so možne snovi za zamenjavo, je treba dovoliti obnovitev dovoljenja zanje, česar ne bi smeli omejiti na eno možnost obnovitve za največ pet let.
As long as essential and viable biocidal products exist based on active substances that are candidates for substitution, the renewal of their authorisation should be allowed, and not be limited to a one-off renewal period of maximum five years.
Člen 21 – odstavek 6 – pododstavek 1 a (novo)
Article 21 – paragraph 6 - subparagraph 1 a (new)
Države članice pripravijo in izvedejo načrt za zamenjavo, s katerim zagotovijo, da se uporaba zadevnega biocidnega pripravka ukine v obdobju veljavnosti dovoljenja in da bo aktivna snov ali pripravek zamenjan s smotrno kemično ali nekemično nadomestno možnostjo.
Member States shall establish and implement a substitution plan in order to ensure that the application of the relevant biocidal product is phased out within the authorisation period and that the relevant active substance or product can be replaced with chemical or non-chemical sound alternatives.
Če se sprejme odločitev, da se ne dovoli ali omeji uporaba biocidnega pripravka v skladu z odstavkom 3, začne navedeni preklic ali sprememba dovoljenja veljati pet let po odločitvi ali na koncu obdobja vključitve možne snovi za zamenjavo, če to nastopi prej.
Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to paragraph 3, that cancellation or amendment of the authorisation shall take effect five years after the decision or at the end of the inclusion period of the candidate for substitution, whichever is the earlier.
Če se sprejme odločitev, da se ne dovoli ali omeji uporaba biocidnega pripravka v skladu z odstavkom 3, začne navedeni preklic ali sprememba dovoljenja veljati tri leta po odločitvi ali na koncu obdobja vključitve možne snovi za zamenjavo, če to nastopi prej.
Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to paragraph 3, that cancellation or amendment of the authorisation shall take effect three years after the decision or at the end of the inclusion period of the candidate for substitution, whichever is the earlier.
Ni sprejemljivo, da bi biocidnim pripravkom dovolili, da ostanejo na trgu še naslednjih pet let, če so na voljo boljše nadomestne možnosti.
It is unacceptable to allow a biocidal product to stay on the market for another five years when better alternatives are available.
Treba je uporabiti enak rok kot v uredbi o fitofarmacevtskih sredstvih.
The same timeline as agreed in the PPP regulation should apply.
V roku enega meseca po prejemu vloge za nacionalno dovoljenje iz člena 15 mora pristojni organ prejemnik preveriti, ali vloga izpolnjuje naslednje zahteve:
Within one month after the receipt of an application for a national authorisation referred to in Article 15, the receiving competent authority shall validate the application if it complies with the following requirements:
Oseba, ki je odgovorna za dajanje biocidnih pripravkov v promet, ali njen zastopnik vloži pri agenciji vlogo za nacionalno dovoljenje ali dovoljenje Unije in obvesti agencijo o imenu pristojnega organa države članice, ki ga sam izbere in ki je odgovoren za oceno vloge (v nadaljnjem besedilu: ocenjevalni pristojni organ).
The person responsible for the placing of a biocidal product on the market, or his representative, shall submit an application for a national or Union authorisation to the Agency and inform the Agency of the name of the competent authority of the Member State of his choice which shall be responsible for the evaluation of the application (hereinafter the ' evaluating competent authority').
Agencija v treh tednih od prejetja vloge obvesti ocenjevalni pristojni organ, da je vloga na voljo v zbirki podatkov agencije.
The Agency shall, within three weeks after the receipt of the application, notify the evaluating competent authority that the application is available in the Agency database.
(a) da so bile predložene informacije iz člena 18;
(a) the information referred to in Article 18 has been submitted;
(b) da so bile plačane pristojbine iz člena 70.
(b) it is accompanied by the fees payable under Article 70.
Validacija ne vključuje ocene kakovosti ali primernosti vseh predloženih podatkov ali obrazložitev za prilagoditev zahtevanih podatkov.
The validation shall not include an assessment of the quality or the adequacy of any data or justifications for the adaptation of data requirements submitted.
ECHA bi morala izvesti prvo validacijo vseh vlog v vsej Skupnosti, da se ocenjevalni pristojni organi lahko osredotočijo na dejansko ocenjevanje vlog.
The ECHA should carry out the initial validation of all applications throughout the Union , so that the evaluating competent authorities can concentrate on actual assessment of the applications.
Ker morajo ocenjevalni pristojni organi zdaj pregledovati tako upravne kot znanstvene elemente dokumentacij, pri njihovem delu pride do nedoslednosti.
Currently, where the evaluating competent authorities consider both the administrative and the scientific aspects of applications, there have been inconsistencies in their approach.
Če pristojni organ prejemnik meni, da vloga ni popolna, predlagatelja obvesti, katere dodatne informacije so potrebne za validacijo vloge ter določi razumen rok za predložitev navedenih informacij.
If the receiving competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information.
Pristojni organ prejemnik v enem mesecu po prejemu dodatnih informacij ugotovi, ali predložene dodatne informacije zadostujejo za validacijo vloge.
The receiving competent authority shall, within one month from the receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.
Če predlagatelj zahtevanih informacij ne predloži v roku, pristojni organ prejemnik vlogo zavrne in o tem obvesti predlagatelja.
The receiving competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and inform the applicant thereof.
Agencija v treh tednih po prejetju vloge validira vlogo, če so izpolnjene naslednje zahteve:
Within three weeks after the receipt of an application, the Agency shall validate the application if it complies with the following requirements:
Evropska agencija za kemikalije bi morala izvesti prvo validacijo vseh vlog v vsej Uniji, da se ocenjevalni pristojni organi lahko osredotočijo na dejansko ocenjevanje vlog.
ECHA should carry out the initial validation of all applications throughout the Community, so that the evaluating competent authorities can concentrate on the actual evaluation of applications.
Trenutno namreč ocenjevalni pristojni organi ugotavljajo pomanjkljivosti pri pristopu, ko morajo poleg upravnih elementov v dokumentaciji upoštevati tudi ekonomske.
Currently, where evaluating competent authorities consider both the administrative and the scientific aspects of applications, there have been inconsistencies in their approach.
Če pristojni organ prejemnik na podlagi validacije, opravljene v skladu z odstavkom 1, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja .
If the receiving competent authority, on basis of the validation made pursuant to paragraph 1, considers that the application is complete , it shall without delay inform the applicant thereof.
Če agencija meni, da je vloga nepopolna , predlagatelja obvesti , katere dodatne informacije so potrebne za validacijo vloge ter določi razumen rok za predložitev navedenih informacij.
If the Agency considers that the application is incomplete , it shall inform the applicant what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information.
Če predlagatelj vloge ne dopolni v roku, agencija zavrne vlogo in o tem obvesti predlagatelja in pristojni ocenjevalni organ.
The Agency shall reject the application if the applicant does not submit the required additional information on time, and shall notify the applicant and the evaluating competent authority of the rejection.
V takšnih primerih se del pristojbine, plačane agenciji v skladu s členom 70, povrne.
In such cases, part of the fees payable to the Agency under Article 70 shall be reimbursed.
Evropska agencija za kemikalije bi morala izvesti prvo validacijo vseh vlog v vsej Skupnosti, da se ocenjevalni pristojni organi lahko osredotočijo na dejansko ocenjevanje vlog.
ECHA should carry out the initial validation of all applications throughout the Community, so that the evaluating competent authorities can concentrate on the actual evaluation of applications.
Agencija bi morala za validacijo vlog upoštevati enake časovne okvire, kot so navedene v uredbi REACH (člen 20).
The Agency should observe the same timeframes for the validation of applications as those introduced under REACH (Article 20).
Predlagatelj lahko v skladu s členom 67 vložijo pritožbo proti odločitvam agencije na podlagi tretjega pododstavka odstavka 3.
An app licant may , in accordance with Article 67, submit an appeal against the decision of the Agency under the third subparagraph of paragraph 3.
Agencija (ECHA) bi morala opraviti prvotno validacijo vseh vlog za dovoljenje Skupnosti, da bi se lahko ocenjevalni pristojni organ osredotočil na dejansko oceno vloge.
ECHA should carry out the initial validation of all applications throughout the Community, so that the evaluating competent authorities can concentrate on the actual evaluation of applications.
Če agencija na podlagi validacije, opravljene v skladu z odstavkom 2, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja in ocenjevalni pristojni organ.
If the Agency, on the basis of the validation made pursuant to paragraph 2, considers that the application is complete, it shall without delay inform the applicant and the evaluating competent authority to that effect .
Pristojni organ prejemnik mora v dvanajstih mesecih po validaciji iz člena 22 sprejeti odločitev o vlogi v skladu s členom 16.
The receiving competent authority shall, within twelve months after the validation referred to in Article 22, decide on the application in accordance with Article 16.
Pristojni organ prejemnik mora v šestih mesecih po validaciji iz člena 22 sprejeti odločitev o vlogi v skladu s členom 16.
The receiving competent authority shall, within six months after the validation referred to in Article 22, decide on the application in accordance with Article 16.
Aktivne snovi v biocidnih pripravkih so že pred vključitvijo v Prilogo I predmet dolgotrajnega ocenjevanja, zato je po mnenju predlagateljev dvanajstmesečno obdobje, predvideno v predlogu uredbe, predolgo za pridobitev dovoljenja za biocidni pripravek, ki je narejen na osnovi dovoljenih aktivnih snovi.
Given the fact that, before being included in Annex I to the regulation, active substances used in biocidal products are already subject to lengthy assessment, it is felt that the period of twelve months provided for in the proposal for a regulation is too long for the authorisation of a biocidal product based on authorised active substances.
Imetnik dovoljenja ali njegov zastopnik vloži vlogo za obnovitev nacionalnega dovoljenja pri pristojnem organu prejemniku najmanj 18 mesecev pred potekom dovoljenja.
The authorisation holder or its representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least 18 months before the expiry date of the authorisation.
Imetnik dovoljenja ali njegov zastopnik vloži vlogo za obnovitev nacionalnega dovoljenja pri pristojnem organu prejemniku najmanj 12 mesecev pred potekom dovoljenja.
The authorisation holder or his representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least 12 months before the expiry date of the authorisation.
12- mesečno obdobje za obnovitev dovoljenja je bolj ustrezno.
12 months would be a more appropriate length of time for the renewal of an authorisation.
Pristojni organ prejemnik lahko zahteva prevod nacionalnega dovoljenja in vloge v enega ali več uradnih jezikov države članice, kjer ima navedeni pristojni organ svoj sedež.
The receiving competent authority may require a translation of the national authorisation and application into one or several of the official languages of the Member State where that competent authority is situated.
Pristojni organ prejemnik lahko zahteva prevod nacionalnega dovoljenja in vloge v enega od uradnih jezikov države članice, kjer ima navedeni pristojni organ svoj sedež.
The receiving competent authority may require a translation of the national authorisation and application into one of the official languages of the Member State where that competent authority is situated.
Vloge za nacionalno dovoljenje, ki vključujejo postopek vzajemnega priznavanja, je mogoče vložiti pri pristojnem organu v angleščini, vključno z dokumenti iz odstavka 18(1).
Applications for a national authorisation which involve a mutual recognition procedure may be submitted to the competent authority in English, including the documents referred to in Article 18(1) .
Možnost, da se prevod zahteva v več kot enem uradnem jeziku (v primerih držav članic z več kot enim jezikom) bi bila lahko za predlagatelja nepotrebno finančno in upravno breme.
The possibility of requiring translations in more than one official language (in cases where there are more than 1 in a given Member State) could place an unnecessary financial and administrative burden on the applicant.
Pristojni organ prejemnik izda dovoljenje za zadevni biocidni pripravek pod enakimi pogoji kot referenčni pristojni organ.
The receiving competent authority shall authorise the biocidal product concerned under the same conditions as the reference competent authority.
Pristojni organ prejemnik izda dovoljenje za zadevni biocidni pripravek pod enakimi pogoji kot referenčni pristojni organ , razen če je odstopanje utemeljeno s posebnimi nacionalnimi okoliščinami v skladu s členom 29 .
The receiving competent authority shall authorise the biocidal product concerned under the same conditions as the reference competent authority , unless specific national circumstances justify a deviation according to A rticle 29 .
V vseh udeleženih državah članicah se uporablja enotna številka dovoljenja.
A single authorisation number shall be used in all the Member States involved.
Enotna številka dovoljenja za vse države članice je najpreprostejša v primeru, ko gre za proizvod, za katerega se je opravil postopek vzajemnega priznavanja.
To simplify matters, a single authorisation number should be assigned in all Member States in the case of products for which a mutual recognition procedure has been followed.
Komisija sprejme ukrepe z delegiranimi akti v skladu s členom 71(a) in pod pogoji iz členov 71(b) in 71(c), pri čemer navede merila in postopke za dodeljevanje enotne številke dovoljenja iz odstavka 5 tega člena.
The Commission shall adopt , by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, measures specifying the criteria and procedures for assigning the single authorisation number referred to in paragraph 5 of this Article.
Člen 27 – odstavek 1 – pododstavek 2
Article 27 – paragraph 1 – subparagraph 2
Komisija sprejme odločitev, ali razlogi, ki jih je navedel pristojni organ, upravičujejo zavrnitev priznanja ali omejitev nacionalnega dovoljenja v skladu s postopkom iz člena 72(3).
The Commission shall adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise, or restriction of, the national authorisation in accordance with the procedure referred to in Article 72(3).
Komisija po posvetovanju s predlagateljem sprejme odločitev, ali razlogi, ki jih je navedel pristojni organ, upravičujejo zavrnitev priznanja ali omejitev nacionalnega dovoljenja v skladu s postopkom iz člena 72(3).
The Commission shall , after consultation with the applicant, adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise, or restriction of, the national authorisation in accordance with the procedure referred to in Article 72(3).
Komisija pripravi predlog sklepa v treh mesecih od prejetja obvestila.
Within three months of receiving the notification, the Commission shall make a proposal for a decision.
Če skladno s postopkom iz člena 30 zaprosi agencijo za mnenje, se obdobje treh mesecev prekine, dokler agencija svojega mnenja ne sporoči.
Should the Commission ask the Agency for an opinion under the procedure set out in Article 30, the three-month period shall be suspended until the Agency has forwarded its opinion.
Besedilo uredbe mora vsebovati določilo o obdobju, v katerem morajo biti spori med državami članicami razrešeni.
The regulation should set out the time period for the resolution of disputes between Member States.
Po mnenju predlagateljev so trije meseci dovolj dolgo obdobje, da lahko Komisija pripravi predlog sklepa o zavrnitvi priznanja ali o omejitvi dovoljenja.
A period of three months is thought to be adequate to enable the Commission to draw up a proposal for a decision to refuse to recognise or to restrict the authorisation.
Člen 28 – odstavek 8 – pododstavek 1 a (novo)
Article 28 – paragraph 8 - subparagraphs 1 a (new)
Komisija sprejme delegirane akte z delegiranimi akti v skladu s členom 71(a) in pod pogoji iz členov 71(b) in 71(c), pri čemer navede merila in postopke za dodeljevanje enotne številke dovoljenja iz pododstavka 1a.
The Commission shall adopt , by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, delegated actsspecifying the criteria and procedures for assigning the single authorisation number referred to in subparagraph 1a .
Komisija po predhodnem posvetovanju s predlagateljem sprejme odločitev, ali razlogi, ki jih je navedel pristojni organ, upravičujejo zavrnitev priznanja ali omejitev nacionalnega dovoljenja v skladu s postopkom iz člena 72(3).
The Commission shall , following consultation of the applicant, adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise, or restriction of, the national authorisation in accordance with the procedure referred to in Article 72(3).
Člen 28 – odstavek 9 – pododstavek 3
Article 28 – paragraph 9 – subparagraph 3
Če se Komisija odloči odkloniti razloge, predložene za zavrnitev ali omejitev nacionalnega dovoljenja, pristojni organ, ki predlaga zavrnitev priznanja dovoljenja ali omejitev dovoljenja, nemudoma izda dovoljenje za zadevni biocidni pripravek v skladu z nacionalnim dovoljenjem, ki ga je izdal referenčni pristojni organ .
If the Commission decision dismisses the grounds presented for refusing or restricting the national authorisation the competent authority that proposed to refuse to recognise the authorisation, or to restrict the authorisation, shall without delay authorise the biocidal product concerned in accordance with the national authorisation issued by the reference competent authority .
Če odločitev Komisije potrdi navedene razloge za zavrnitev ali omejitev poznejšega dovoljenja, pristojni organ, ki je predhodno izdal dovoljenje za biocidni pripravek , nemudoma preveri svoje nacionalno dovoljenje, da bo v skladu z navedeno odločitvijo.
If the Commission decision confirms the grounds presented for refusing or restricting the subsequent authorisation, the competent authority that had previously authorised the biocidal product shall without delay review its national authorisation to comply with that decision .
Če odločitev Komisije potrdi prvotno nacionalno dovoljenje, pristojni organ, ki je predlagal zavrnitev priznanja nacionalnega dovoljenja ali priznanje nacionalnega dovoljenja pod določenimi pogoji, nemudoma izda dovoljenje za zadevni biocidni pripravek v skladu s prvotnim dovoljenjem.
If the Commission decision confirms the initial national authorisation, the competent authority that proposed to refuse to recognise a national authorisation, or to recognise the national authorisation subject to certain conditions, shall without delay authorise the biocidal product concerned in accordance with the initial authorisation.
Člen 29 – odstavek 1 – pododstavek 1 – uvodni del
Article 29 – paragraph 1 – subparagraph 1 - introductory part
Pristojni organ, ki je prejel vlogo za medsebojno priznavanje v skladu s členom 25 ali 28, lahko v dveh mesecih po prejemu vloge predlagatelju predlaga, da se nekateri pogoji iz točk (e), (f), (h), (j) in (l) člena 58(2) v dovoljenju prilagodijo lokalnim okoliščinam, da bodo tako izpolnjeni pogoji za izdajo dovoljenja iz člena 16, ter o tem obvesti Komisijo, če ugotovi, da je na njegovem ozemlju izpolnjen eden izmed naslednjih pogojev:
The competent authority that has received an application for mutual recognition in accordance with Articles 25 or 28 may, within two months from the receipt of the application, propose to the applicant that certain conditions referred to in points (e), (f), (h), (j) and (l) of Article 58(2) in the authorisation be adjusted to local circumstances, so that conditions for issue of an authorisation laid down in Article 16 are satisfied, and shall inform the Commission thereof, if it establishes that, in its territory, one of the following conditions is met:
Pristojni organ, ki je prejel vlogo za medsebojno priznavanje v skladu s členom 25 ali 28, lahko v dveh mesecih po prejemu vloge predlagatelju predlaga, da se nekateri pogoji iz točk (d), (e), (f), (h), (j), (k) in (l) člena 58(2) v dovoljenju prilagodijo lokalnim okoliščinam, da bodo tako izpolnjeni pogoji za izdajo dovoljenja iz člena 16, ter o tem obvesti Komisijo, če ugotovi, da je na njegovem ozemlju izpolnjen eden izmed naslednjih pogojev:
The competent authority that has received an application for mutual recognition in accordance with Articles 25 or 28 may, within two months from the receipt of the application, propose to the applicant that certain conditions referred to in points ( d) , ( e), (f), (h), (j) , (k) and (l) of Article 58(2) in the authorisation be adjusted to local circumstances, so that conditions for issue of an authorisation laid down in Article 16 are satisfied, and shall inform the Commission thereof, if it establishes that, in its territory, one of the following conditions is met: