natgillin/translations-raw huggingface dataset:
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, 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.
V takšnih primerih se del pristojbine, plačane v skladu s členom 80
In such cases, part of the fee paid in accordance with Article 80
Ob validaciji vloge v skladu z odstavkom 3 ali 4 ocenjevalni pristojni organ o tem nemudoma ustrezno obvesti vlagatelja, Agencijo in druge pristojne organe, pri čemer navede točni datum validacije.
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 and indicate the exact date of the validation.
V skladu s členom 77 se lahko proti sklepom Agencije na podlagi odstavka 2 tega odstavka vloži pritožba.
An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraph 2 of this Article.
Ocenjevanje vlog
Evaluation of applications
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.
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.
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.
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.
Ocenjevalni pristojni organ te pripombe ustrezno upošteva pri končni oceni.
The evaluating competent authority shall take due account of those comments when finalising its evaluation.
tveganja za zdravje ljudi ali okolje
for human health or the environment as a result of
, ki vsebujejo isto
the cumulative effects from the use of biocidal products containing the same
ali drugačno
or different
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.
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.
Odobritev aktivne snovi
Approval of an active substance
sprejme izvedbeno uredbo o odobritvi aktivne snovi in o pogojih za to odobritev, vključno z datumi odobritve in poteka odobritve; ali
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
v primerih, ko zahteve iz člena 4(1) ali, kadar je ustrezno, člena 5(2) niso izpolnjene, ali kadar potrebne informacije in podatki niso bili predloženi v predpisanem roku, sprejme izvedbeni sklep, da se aktivna snov ne odobri.
in cases where the requirements of Article 4(1) or, where applicable, 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.
Aktivne snovi, ki so možne snovi za zamenjavo
Active substances which are candidates for substitution
Aktivna snov šteje za možno snov za zamenjavo, če je izpolnjen kateri od naslednjih pogojev:
An active substance shall be considered a candidate for substitution if any of the following conditions are met:
izpolnjuje vsaj eno merilo za izključitev, navedeno v členu 5(1), vendar se lahko odobri v skladu s členom 5(2);
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 merila, na podlagi katerih je v skladu z Uredbo (ES) št. 1272/2008 razvrščena kot povzročitelj preobčutljivosti dihal;
it meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as a respiratory sensitiser;
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;
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;
ustreza dvema meriloma, na podlagi katerih se v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006 šteje za obstojno snov, snov, ki se kopiči v organizmih, ali strupeno snov;
it meets two of the criteria to be considered as a persistent, bio-accumulative and toxic substance as set out in Annex XIII of Regulation (EC) No 1907/2006;
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;
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;
vsebuje precejšnji delež neaktivnih izomerov ali nečistot.
it contains a significant proportion of non-active isomers or impurities.
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.
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.
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.
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.
Agencija prejete informacije ustrezno upošteva pri končni oceni.
The Agency shall take due account of the information received when finalising its opinion.
Z odstopanjem od členov 4(1) in 12(3) se odobritev aktivne snovi, ki se šteje kot možna snov za zamenjavo in vsako obnovitev podaljšanje poda za obdobje največ sedem let.
By way of derogation from Articles 4(1) and 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.
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.
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.
Tehnična navodila
Technical guidance notes
Komisija pripravi tehnična navodila za lažje izvajanje tega poglavja, zlasti členov 5(2) in 10(1).
The Commission shall draw up technical guidance notes to facilitate the implementation of this Chapter, in particular Articles 5(2) and 10(1).
PODALJŠANJE IN PREGLED ODOBRITVE AKTIVNE SNOVI
RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE
Pogoji za podaljšanje
Conditions for renewal
Če aktivna snov še vedno izpolnjuje pogoj iz člena 4(1) in po potrebi pogoje iz člena 5(2), Komisija obnovi njeno odobritev.
The Commission shall renew the approval of an active substance if the active substance still meets the condition laid down in Article 4(1) and, where relevant, the conditions set out in Article 5(2).
Ob upoštevanju znanstvenega in tehničnega napredka se pogoji za aktivno snov iz člena 4(3) pregledajo in po potrebi spremenijo.
In the light of scientific and technical progress, the conditions specified for the active substance referred to in Article 4(3) shall be reviewed and, where appropriate, amended.
za petnajst let za vse vrste proizvodov, na katere se odobritev nanaša
renewal shall be for fifteen years for all product-types to which the approval applies
, razen če v uredbi o podaljšanju odobritve aktivne snovi ni določeno krajše obdobje
, unless a shorter period is specified in the Regulation renewing the approval of an active substance
Vložitev in sprejetje vlog
Submission and acceptance of applications
Vlagatelji, ki želijo podaljšati odobritev aktivne snovi za eno ali več vrst proizvodov, pri Agenciji vložijo vlogo najmanj 550 dni pred iztekom odobritve.
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.
Kadar imajo različne vrste proizvodov različni datum izteka, se vloga vloži najmanj 550 dni pred datumom izteka, ki nastopi najprej.
Where there are different expiry dates for different product-types, the application shall be submitted at least 550 days before the earliest expiry date.
Ob vložitvi vloge za podaljšanje odobritve aktivne snovi vlagatelj predloži:
When applying for the renewal of the approval of the active substance, the applicant shall submit:
svojo oceno o tem, ali so ugotovitve iz prvotne ali predhodne ocene aktivne snovi še naprej veljavne, in ustrezna dokazila.
its assessment of whether the conclusions of the initial or previous assessment of the active substance remain valid and any supporting information.
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.
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.
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.
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.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 80(1), Agencija sprejme vlogo in o tem ustrezno obvesti vlagatelja in ocenjevalni pristojni organ, pri čemer navede točni datum sprejetja.
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 exact date of the acceptance.
V skladu s členom 77 se lahko proti sklepom Agencije na podlagi odstavka 3 tega odstavka vloži pritožba.
An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraph 3 of this Article.
Ocenjevanje vlog za podaljšanje
Evaluation of applications for renewal
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.
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.
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 necessary, the evaluation shall be carried out in accordance with paragraphs 1, 2 and 3 of Article 8.
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.
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.
Ocenjevalni pristojni organ vlagatelju pošlje kopijo svojega priporočila.
It shall provide the applicant with a copy of its recommendation.
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.
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.
Komisija ob prejemu mnenja Agencije sprejme:
The Commission shall, on receipt of the opinion of the Agency, adopt:
izvedbeno uredbo o podaljšanju odobritve aktivne snovi za eno ali več vrst proizvodov in o pogojih za to podaljšanje ali
an implementing Regulation providing that the approval of an active substance is renewed for one or more product-types, and under which conditions; or
izvedbeni sklep, da se odobritev aktivne snovi ne obnovi.
an implementing decision that the approval of an active substance is not renewed.
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.
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.
Ti izvedbeni akti se sprejmejo v skladu s posvetovalnim postopkom iz člena 82(2).
Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 82(2).
Če Komisija odloči, da odobritve aktivne snovi za eno ali več vrst proizvodov ne obnovi
Where the Commission decides not to renew
ali da jo spremeni
or decides to amend
države članice ali, v primeru dovoljenja Unije, Komisija, prekličejo ali, kjer je potrebno, spremenijo dovoljenja
the Member States or, in the case of a Union authorisation, the Commission shall cancel or, where appropriate, amend the authorisations
biocidnih proizvodov, ki vsebujejo to aktivno snov.
of biocidal products of the product-type(s) concerned containing that active substance.
Ustrezno se uporabljata člena 48 in 52.
Article 48 and 52 shall apply accordingly.
Pregled odobritve aktivne snovi
Review of approval of an active substance
Komisija lahko kadarkoli pregleda odobritev aktivne snovi za eno ali več vrst proizvodov, če se pojavijo
The Commission may review the approval of an active substance for one or more product-types at any time where there are
znaki, da pogoji iz člena 4(1) ali po potrebi člena 5(2) niso več izpolnjeni.
indications that the conditions laid down in Article 4(1) or, where relevant, Article 5(2) are no longer met.
Komisija lahko na zahtevo države članice pregleda tudi odobritev aktivne snovi za eno ali več vrst proizvodov, če se pojavijo
The Commission may also review the approval of an active substance for one or more product-types at the request of a Member State if there are indications that the use of the active substance in biocidal products or treated articles raises
znaki, da uporaba aktivne snovi v biocidnem proizvodu ali tretiranem izdelku povzroča resno zaskrbljenost glede varnosti tega biocidnega proizvoda ali tretiranega izdelka.
concerns about the safety of such biocidal products or treated articles.
Komisija javnost obvesti, da opravlja pregled, vlagatelju pa omogoči, da predloži pripombe.
The Commission shall make publicly available the information that it is carrying out a review and shall provide an opportunity for the applicant to submit comments.
Komisija te pripombe pri pregledu ustrezno upošteva.
The Commission shall take due account of those comments in its review
Ta izvedbena uredba se sprejme v skladu s postopkom pregleda iz člena 82(3).
That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 82(3).
Komisija ustrezno obvesti prvotnega vlagatelja ali vlagatelje vloge za odobritev.
The Commission shall inform the initial applicant(s) for the approval accordingly.
V ustrezno utemeljenih nujnih primerih lahko Komisija v skladu s postopkom iz člena 82(4) sprejme izvedbene akte, ki se začnejo nemudoma uporabljati.
On duly justified imperative grounds of urgency the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 82(4).
Komisija se lahko o katerih koli znanstvenih ali tehničnih vprašanjih, povezanih s pregledom odobritve aktivne snovi, posvetuje z Agencijo.
The Commission may consult the Agency on any questions of a scientific or technical nature related to the review of approval of an active substance.
Agencija v 270 dneh od datuma zahteve pripravi mnenje in ga predloži Komisiji.
The Agency shall, within 270 days of the request, prepare an opinion and submit it to the Commission.
Kadar Komisija
Where the Commission
ali spremeni
or amend
odobritev aktivne snovi
the approval of an active substance
Ustrezno se uporabljata člena 48 in 52.
Articles 48 and 52 shall apply accordingly.
Komisija lahko z izvedbenimi akti sprejme podrobne ukrepe za izvajanje členov 12 do 15, s katerimi se podrobneje določijo postopki za podaljšanje in pregled odobritve aktivne snovi.
The Commission may adopt, by means of implementing acts, detailed measures for the implementation of Articles 12 to 15, further specifying the procedures for the renewal and review of the approval of an active substance.
SPLOŠNA NAČELA ZA DOVOLJENJA ZA BIOCIDNE PROIZVODE
GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS
Dostopnost na trgu in uporaba biocidnih proizvodov
Making available on the market and use of biocidal products
Biocidni proizvodi niso dostopni na trgu oziroma se ne uporabljajo, razen če je bilo za to izdano dovoljenje v skladu s to uredbo.
Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation.
Vloge za dovoljenje vloži morebitni imetnik dovoljenja ali se vložijo v njegovem imenu.
Applications for authorisation shall be made by, or on behalf of, the prospective authorisation holder.
Vloge za nacionalno dovoljenje v državi članici se vložijo pri pristojnem organu te države članice (v nadaljnjem besedilu: pristojni organ prejemnik).
Applications for national authorisation in a Member State shall be submitted to the competent authority of that Member State (‘the receiving competent authority’).
Vloge za dovoljenje Unije se vložijo pri Agenciji.
Applications for Union authorisation shall be submitted to the Agency.
Dovoljenje za biocidni proizvod se lahko izda za posamezen biocidni proizvod ali družino biocidnih proizvodov.
An authorisation for a biocidal product may be granted for a single biocidal product or a biocidal product family.
Dovoljenje se izda za največ 10 let.
An authorisation shall be granted for a maximum period of 10 years.
Biocidni proizvodi se uporabljajo v skladu z določili in pogoji za izdajo dovoljenja, določenimi v skladu s členom 22(1), ter z zahtevami glede označevanja in pakiranja iz člena 69.
Biocidal products shall be used in compliance with the terms and conditions of the authorisation stipulated in accordance with Article 22(1) and the labelling and packaging requirements laid down in Article 69.
Pravilna uporaba vključuje racionalno izvajanje skupka fizikalnih, bioloških, kemijskih ali po potrebi drugih ukrepov, pri čemer je uporaba biocidnih proizvodov omejena na najmanjšo potrebno mero, ki jo spremljajo sprejeti varnostni ukrepi.
Proper use shall involve the rational application of a combination of physical, biological, chemical or other measures as appropriate, whereby the use of biocidal products is limited to the minimum necessary and appropriate precautionary steps are taken.
Države članice sprejmejo potrebne ukrepe, da javnosti zagotovijo ustrezne informacije o koristih in tveganjih, povezanih z biocidnimi proizvodi, ter informacije o načinih za čim manjšo uporabo biocidnih proizvodov.
Member States shall take necessary measures to provide the public with appropriate information about the benefits and risks associated with biocidal products and ways of minimising their use.
Imetnik dovoljenja uradno obvesti vsak pristojni organ, ki je izdal nacionalno dovoljenje za družino biocidnih proizvodov, o vsakem proizvodu te družine biocidnih proizvodov,
The authorisation holder shall notify each competent authority that has granted a national authorisation for a biocidal product family of each product within the biocidal product family
najmanj 30 dni,
at least 30 days
preden ga da na trg, razen takrat, kadar je določeni proizvod izrecno opredeljen v dovoljenju ali kadar se odstopanje v sestavi nanaša le na pigmente, dišave in barvila, in sicer v okviru dovoljenih odstopanj.
before placing it on the market, except where a particular product is explicitly identified in the authorisation or the variation in composition concerns only pigments, perfumes and dyes within the permitted variations.
Komisija z izvedbenim aktom določi postopke za izdajo dovoljenja za iste biocidne proizvode istega ali drugega podjetja pod enakimi pogoji.
The Commission shall, by means of an implementing act, specify procedures for the authorisation of the same biocidal products by the same or different enterprises under the same terms and conditions.
Ta izvedbeni akt se sprejme v skladu s postopkom pregleda iz člena 82(3).
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 82(3).
UL: Prosimo vstavite datum – tri leta po začetku veljavnosti te uredbe.
OJ: Insert the date - three years after the entry into force of this Regulation.