natgillin/translations-raw huggingface dataset:
The applicant shall submit an application for approval of an active substance, or for making subsequent amendments to the conditions of approval of an active substance, to the Agency, informing it of the name of the competent authority of the Member State that it proposes should evaluate the application and providing written confirmation that that competent authority agrees to do so.
Vlagatelj pri agenciji vloži vlogo za odobritev aktivne snovi ali za naknadne spremembe pogojev za odobritev aktivne snovi ter Agencijo obvesti o nazivu pristojnega organa države članice, ki ga predlaga za ocenjevanje vloge, in predloži pisno potrdilo pristojnega organa, da se s tem strinja.
That competent authority shall be the evaluating competent authority.
Ta pristojni organ je ocenjevalni pristojni organ.
The Agency shall inform the applicant of the fees payable under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days.
Agencija vlagatelja obvesti o pristojbinah, ki se plačujejo v skladu s členom 80(1), in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
It shall inform the applicant and the evaluating competent authority accordingly.
Agencija ustrezno obvesti vlagatelja in ocenjevalni pristojni organ.
Upon receipt of the fees payable under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the date of the acceptance of the application and its unique identification code.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 80(1), Agencija sprejme vlogo in o tem obvesti vlagatelja in ocenjevalni pristojni organ, pri čemer navede datum sprejema vloge in njeno enkratno identifikacijsko kodo.
Within 30 days of the Agency accepting an application, the evaluating competent authority shall validate the application if the data required in accordance with points (a) and (b) and, where relevant, point (c) of Article 6(1), and any justifications for the adaptation of data requirements, have been submitted.
Ocenjevalni pristojni organ v 30 dneh po tem, ko Agencija sprejme vlogo, validira vlogo, če so bili predloženi podatki, ki se zahtevajo v skladu s točkama (a) in (b) in, po potrebi, točko (c) člena 6(1), ter predložene kakršne koli utemeljitve za prilagoditev zahtev glede podatkov.
In the context of the validation referred to in the first subparagraph, the evaluating competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
Ocenjevalni pristojni organ v okviru validacije iz prvega pododstavka ne opravi ocene kakovosti ali ustreznosti predloženih podatkov ali utemeljitev.
The evaluating competent authority shall, as soon as possible after the Agency has accepted an application, inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days.
Potem ko je Agencija sprejela vlogo, ocenjevalni pristojni organ čim prej obvesti vlagatelja o pristojbinah, ki se plačujejo v skladu s členom 80(2), in zavrne vlogo, če vlagatelj pristojbin ne plača v 30 dneh.
It shall inform the applicant accordingly.
Vlagatelja o tem ustrezno obvesti.
Where the evaluating 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.
Kadar ocenjevalni pristojni organ meni, da je vloga nepopolna, vlagatelja obvesti, katere dodatne informacije so potrebne za validacijo vloge, in določi razumen rok za predložitev teh informacij.
That time limit shall not normally exceed 90 days.
Ta rok običajno ne presega 90 dni.
The evaluating competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph 3.
Ocenjevalni pristojni organ v 30 dneh po prejemu dodatnih informacij validira vlogo, če odloči, da predložene dodatne informacije zadostujejo za izpolnitev zahtev iz odstavka 3.
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 and the Agency accordingly.
Če vlagatelj zahtevanih informacij ne predloži v roku, ocenjevalni pristojni organ vlogo zavrne in o tem ustrezno obvesti vlagatelja in Agencijo.
In such cases, part of the fees paid in accordance with Article 80(1) and (2) shall be reimbursed.
V takšnih primerih se del pristojbin, plačanih v skladu s členom 80(1) in (2), povrne.
On validating an application in accordance with paragraph 3 or 4, the evaluating competent authority shall without delay inform the applicant, the Agency and other competent authorities accordingly, indicating the date of the validation.
Ob validaciji vloge v skladu z odstavkom 3 ali 4 ocenjevalni pristojni organ o tem nemudoma obvesti vlagatelja, Agencijo in druge pristojne organe, pri čemer navede datum validacije.
An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraph 2 of this Article.
V skladu s členom 77 se lahko proti sklepom Agencije na podlagi odstavka 2 tega člena vloži pritožba.
The evaluating competent authority shall, within 365 days of the validation of an application, evaluate it in accordance with Articles 4 and 5, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3), and send an assessment report and the conclusions of its evaluation to the Agency.
Ocenjevalni pristojni organ vlogo v 365 dneh po njeni validaciji oceni v skladu s členoma 4 in 5, po potrebi pa tudi vse predloge za prilagoditev zahtev glede podatkov, ki so bili predloženi v skladu s členom 6(3), in Agenciji pošlje poročilo o oceni in ugotovitve ocenjevanja.
Prior to submitting its conclusions to the Agency, the evaluating competent authority shall give the applicant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days.
Preden ocenjevalni pristojni organ svoje ugotovitve predloži Agenciji, da vlagatelju možnost, da v 30 dneh predloži pisne pripombe glede poročila o oceni in ugotovitev ocenjevanja.
The evaluating competent authority shall take due account of those comments when finalising its evaluation.
Ocenjevalni pristojni organ te pripombe ustrezno upošteva pri končni oceni.
Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit, and shall inform the Agency accordingly.
Če se izkaže, da so za izvedbo ocene potrebne dodatne informacije, ocenjevalni pristojni organ od vlagatelja zahteva, da v določenem roku predloži take informacije, in ustrezno obvesti Agencijo.
As specified in the second subparagraph of Article 6(2), the evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to permit a determination of whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1).
Kot je določeno v drugem pododstavku člena 6(2), lahko ocenjevalni pristojni organ po potrebi od vlagatelja zahteva, da zagotovi dovolj podatkov, na podlagi katerih je mogoče ugotoviti, ali aktivna snov izpolnjuje merila iz člena 5(1) ali člena 10(1).
The 365-day period referred to in paragraph 1 of this Article shall be suspended from the date of issue of the request until the date the information is received.
Obdobje 365 dni iz odstavka 1 tega člena se prekine od dneva izdaje zahtevka do dneva prejema informacij.
The suspension shall not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.
Prekinitev skupno ne presega 180 dni, razen če je to upravičeno zaradi narave zahtevanih podatkov ali izrednih okoliščin.
Where the evaluating competent authority considers that there are concerns for human health, animal health or the environment as a result of the cumulative effects from the use of biocidal products containing the same or different active substances, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 and include this as part of its conclusions.
Kadar ocenjevalni pristojni organ meni, da zaradi kumulativnih učinkov uporabe biocidnih proizvodov obstajajo tveganja za zdravje človeka, zdravje živali ali okolje, ki vsebujejo isto ali drugačne aktivne snovi, svoje pomisleke dokumentira skladno z zahtevami ustreznih delov oddelka II.3 Priloge XV k Uredbi (ES) št. 1907/2006 in jih vključi med svoje ugotovitve.
Within 270 days of receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the approval of the active substance having regard to the conclusions of the evaluating competent authority.
Agencija v 270 dneh po prejemu ugotovitev ocenjevanja pripravi mnenje o odobritvi aktivne snovi in ga predloži Komisiji, pri tem pa upošteva ugotovitve ocenjevalnega pristojnega organa.
Approval of an active substance
Odobritev aktivne snovi
The Commission shall, on receipt of the opinion of the Agency referred to in Article 8(4), either:
Komisija ob prejemu mnenja Agencije iz člena 8(4) bodisi:
adopt an implementing Regulation providing that an active substance is approved, and under which conditions, including the dates of approval and of expiry of the approval; or
sprejme izvedbeno uredbo o odobritvi aktivne snovi in o pogojih za to odobritev, vključno z datumi odobritve in poteka odobritve, ali
in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, adopt an implementing decision that an active substance is not approved.
v primerih, ko pogoji iz člena 4(1) ali, kadar je ustrezno, pogoji iz člena 5(2) niso izpolnjeni ali kadar potrebne informacije in podatki niso bili predloženi v predpisanem roku, sprejme izvedbeni sklep, da se aktivna snov ne odobri.
Approved active substances shall be included in a Union list of approved active substances.
Odobrene aktivne snovi se vključijo na seznam odobrenih aktivnih snovi Unije.
The Commission shall keep the list up to date and make it electronically available to the public.
Komisija seznam posodablja in ga v elektronski obliki da na razpolago javnosti.
Active substances which are candidates for substitution
Aktivne snovi, ki so možne snovi za zamenjavo
An active substance shall be considered a candidate for substitution if any of the following conditions are met:
Aktivna snov šteje za možno snov za zamenjavo, če je izpolnjen kateri od naslednjih pogojev:
it meets at least one of the exclusion criteria listed in Article 5(1) but may be approved in accordance with Article 5(2);
izpolnjuje vsaj eno merilo za izključitev, navedeno v členu 5(1), vendar se lahko odobri v skladu s členom 5(2);
it meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as a respiratory sensitiser;
izpolnjuje merila, na podlagi katerih je v skladu z Uredbo (ES) št. 1272/2008 razvrščena kot povzročitelj preobčutljivosti dihal;
its acceptable daily intake, acute reference dose or acceptable operator exposure level, as appropriate, is significantly lower than those of the majority of approved active substances for the same product-type and use scenario;
dopustni dnevni vnos, akutni referenčni odmerek ali po potrebi sprejemljive ravni izpostavljenosti delavca so občutno nižji kot pri večini odobrenih aktivnih snovi za enako vrsto proizvodov in enak način uporabe;
it meets two of the criteria for being PBT in accordance with Annex XIII to Regulation (EC) No 1907/2006;
ustreza dvema meriloma, na podlagi katerih se v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006 šteje za PBT;
there are reasons for concern linked to the nature of the critical effects which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures;
obstajajo razlogi za zaskrbljenost, povezani z naravo kritičnih učinkov, ki v kombinaciji z vzorci uporabe povzročijo uporabo, ki lahko tudi ob zelo restriktivnih ukrepih za obvladovanje tveganja še vedno zbuja zaskrbljenost, kot denimo visoka raven tveganja za podtalnico;
it contains a significant proportion of non-active isomers or impurities.
vsebuje precejšnji delež neaktivnih izomerov ali nečistot.
When preparing its opinion on the approval or renewal of the approval of an active substance, the Agency shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and address the matter in its opinion.
Agencija pri pripravi svojega mnenja o odobritvi ali podaljšanju odobritve aktivne snovi preuči, ali aktivna snov izpolnjuje katero izmed meril, naštetih v odstavku 1, in zadevo obravnava v svojem mnenju.
Prior to submitting its opinion on the approval or renewal of the approval of an active substance to the Commission, the Agency shall make publicly available, without prejudice to Articles 66 and 67, information on potential candidates for substitution during a period of no more than 60 days, during which time interested third parties may submit relevant information, including information on available substitutes.
Preden Agencija Komisiji predloži svoje mnenje o odobritvi ali podaljšanju odobritve aktivne snovi, da brez poseganja v člena 66 in 67 javnosti na razpolago informacije o možnih snoveh za zamenjavo, in sicer za največ 60 dni, v katerih lahko zainteresirane tretje strani predložijo ustrezne informacije, vključno z informacijami o razpoložljivih nadomestkih.
The Agency shall take due account of the information received when finalising its opinion.
Agencija prejete informacije ustrezno upošteva pri končni oceni.
By way of derogation from Article 4(1) and Article 12(3), the approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding seven years.
Z odstopanjem od člena 4(1) in člena 12(3) se odobritev aktivne snovi, ki se šteje kot možna snov za zamenjavo, in vsako obnovitev podaljšanje poda za obdobje največ sedem let.
Active substances that are considered as candidates for substitution in accordance with paragraph 1 shall be identified as such in the relevant Regulation adopted in accordance with Article 9.
Aktivne snovi, ki se štejejo kot možne snovi za zamenjavo v skladu z odstavkom 1, se kot take opredelijo v ustrezni uredbi, sprejeti v skladu s členom 9.
Technical guidance notes
Tehnična navodila
The Commission shall draw up technical guidance notes to facilitate the implementation of this Chapter, in particular Article 5(2) and Article 10(1).
Komisija pripravi tehnična navodila za lažje izvajanje tega poglavja, zlasti člena 5(2) in člena 10(1).
RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE
PODALJŠANJE IN PREGLED ODOBRITVE AKTIVNE SNOVI
Conditions for renewal
Pogoji za podaljšanje
The Commission shall renew the approval of an active substance if the active substance still meets the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2).
Če aktivna snov še vedno izpolnjuje pogoje iz člena 4(1) ali, kadar je ustrezno, pogoje iz člena 5(2), Komisija podaljša njeno odobritev.
In the light of scientific and technical progress, the Commission shall review and, where appropriate, amend the conditions specified for the active substance referred to in Article 4(3).
Ob upoštevanju znanstvenega in tehničnega napredka se pogoji za aktivno snov iz člena 4(3) pregledajo in po potrebi spremenijo.
The renewal of an approval of an active substance shall be for 15 years for all product-types to which the approval applies, unless a shorter period is specified in the implementing regulation adopted in accordance with point (a) of Article 14(4) renewing such an approval.
Podaljšanje odobritve aktivne snovi velja 15 let za vse vrste proizvodov, na katere se odobritev nanaša, razen če v izvedbeni uredbi, sprejeti v skladu s točko (a) člena 14(4), za podaljšanje take odobritve ni določeno krajše obdobje.
Submission and acceptance of applications
Vložitev in prejem vlog
Applicants wishing to seek renewal of the approval of an active substance for one or more product-types shall submit an application to the Agency at least 550 days before the expiry of the approval.
Vlagatelji, ki želijo podaljšati odobritev aktivne snovi za eno ali več vrst proizvodov, pri Agenciji vložijo vlogo najmanj 550 dni pred iztekom odobritve.
Where there are different expiry dates for different product-types, the application shall be submitted at least 550 days before the earliest expiry date.
Kadar imajo različne vrste proizvodov različni datum izteka, se vloga vloži najmanj 550 dni pred datumom izteka, ki nastopi najprej.
When applying for the renewal of the approval of the active substance, the applicant shall submit:
Ob vložitvi vloge za podaljšanje odobritve aktivne snovi vlagatelj predloži:
without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial approval or, as appropriate, previous renewal; and
brez poseganja v člen 21(1) vse ustrezne podatke, ki se zahtevajo v skladu s členom 20 in so bili ustvarjeni po prvotni odobritvi ali predhodnem podaljšanju, kakor je primerno, in
its assessment of whether the conclusions of the initial or previous assessment of the active substance remain valid and any supporting information.
svojo oceno o tem, ali so ugotovitve iz prvotne ali predhodne ocene aktivne snovi še naprej veljavne, in ustrezna dokazila.
The applicant shall also submit the name of the competent authority of the Member State that it proposes should evaluate the application for renewal and provide written confirmation that that competent authority agrees to do so.
Vlagatelj predloži tudi ime pristojnega organa države članice, ki ga predlaga za ocenjevanje vloge za podaljšanje, in pisno potrdilo zadevnega pristojnega organa, da se s tem strinja.
Upon receipt of the fees payable under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the date of the acceptance.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 80(1), Agencija sprejme vlogo in o tem obvesti vlagatelja in ocenjevalni pristojni organ, pri čemer navede datum sprejema.
An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraph 3 of this Article.
V skladu s členom 77 se lahko proti sklepom Agencije na podlagi odstavka 3 tega člena vloži pritožba.
Evaluation of applications for renewal
Ocenjevanje vlog za podaljšanje
On the basis of an assessment of the available information and the need to review the conclusions of the initial evaluation of the application for approval or, as appropriate, the previous renewal, the evaluating competent authority shall, within 90 days of the Agency accepting an application in accordance with Article 13(3), decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary taking account of all product-types for which renewal is requested.
Na podlagi ocene razpoložljivih informacij in potrebe po pregledu ugotovitev iz prvotne ocene vloge za odobritev ali predhodnega podaljšanja, kakor je primerno, ocenjevalni pristojni organ v 90 dneh po tem, ko Agencija sprejme vlogo v skladu s členom 13(3), odloči, ali je glede na sedanja znanstvena spoznanja potrebna popolna ocena vloge za podaljšanje, ob upoštevanju vseh vrst proizvodov, za katere se podaljšanje zahteva.
Where the evaluating competent authority decides that a full evaluation of the application is necessary, the evaluation shall be carried out in accordance with paragraphs 1, 2 and 3 of Article 8.
Če ocenjevalni pristojni organ odloči, da je potrebna popolna ocena vloge, se ocenjevanje opravi v skladu z odstavki 1, 2 in 3 člena 8.
Where the evaluating competent authority decides that a full evaluation of the application is not necessary, it shall, within 180 days of the Agency accepting the application in accordance with Article 13(3), prepare and submit to the Agency a recommendation on the renewal of the approval of the active substance.
Če ocenjevalni pristojni organ odloči, da popolna ocena vloge ni potrebna, v 180 dneh po tem, ko Agencija sprejme vlogo v skladu s členom 13(3), pripravi priporočilo za podaljšanje odobritve aktivne snovi in ga predloži Agenciji.
It shall provide the applicant with a copy of its recommendation.
Ocenjevalni pristojni organ vlagatelju pošlje kopijo svojega priporočila.
The evaluating competent authority shall, as soon as possible after the Agency has accepted an application, notify the applicant of the fees payable under Article 80(2).
Potem ko je Agencija sprejela vlogo, ocenjevalni pristojni organ čim prej uradno obvesti vlagatelja o pristojbinah, ki se plačujejo v skladu s členom 80(2).
The evaluating competent authority shall reject the application if the applicant fails to pay the fees within 30 days of the notification and shall inform the applicant accordingly.
Ocenjevalni pristojni organ zavrne vlogo, če vlagatelj ne plača pristojbin v 30 dneh od uradnega obvestila in vlagatelja o tem ustrezno obvesti.
Within 270 days of receipt of a recommendation from the evaluating competent authority, if it has carried out a full evaluation of the application, or 90 days otherwise, the Agency shall prepare and submit to the Commission an opinion on renewal of the approval of the active substance.
V 270 dneh po tem, ko Agencija prejme priporočilo od ocenjevalnega pristojnega organa, če je ta opravil popolno oceno vloge, v nasprotnem primeru pa v 90 dneh, Agencija pripravi mnenje o podaljšanju odobritve aktivne snovi in ga predloži Komisiji.
The Commission shall, on receipt of the opinion of the Agency, adopt:
Komisija ob prejemu mnenja Agencije sprejme:
an implementing regulation providing that the approval of an active substance is renewed for one or more product-types, and under which conditions; or
izvedbeno uredbo o podaljšanju odobritve aktivne snovi za eno ali več vrst proizvodov in o pogojih za to podaljšanje ali
an implementing decision that the approval of an active substance is not renewed.
izvedbeni sklep, da se odobritev aktivne snovi ne obnovi.
Article 9(2) shall apply.
Uporablja se člen 9(2).
Where, for reasons beyond the control of the applicant, the approval of the active substance is likely to expire before a decision has been taken on its renewal, the Commission shall, by means of implementing acts, adopt a decision postponing the expiry date of approval for a period sufficient to enable it to examine the application.
Kadar je verjetno, da se bo odobritev aktivne snovi zaradi razlogov, na katere vlagatelj nima vpliva, iztekla, preden bo sprejeta odločitev o njenem podaljšanju, Komisija z izvedbenimi akti sprejme sklep o odložitvi datuma izteka odobritve za obdobje, ki ji bo zadoščalo za preučitev vloge.
Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 82(2).
Ti izvedbeni akti se sprejmejo v skladu s posvetovalnim postopkom iz člena 82(2).
Where the Commission decides not to renew or decides to amend the approval of an active substance for one or more product-types, the Member States or, in the case of a Union authorisation, the Commission shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance.
Če Komisija odloči, da odobritve aktivne snovi za eno ali več vrst proizvodov ne podaljša ali da jo spremeni, države članice ali, v primeru dovoljenja Unije, Komisija prekličejo ali, kjer je potrebno, spremenijo dovoljenja biocidnih proizvodov zadevne vrste oziroma vrst proizvodov, ki vsebujejo to aktivno snov.