natgillin/translations-raw huggingface dataset:
The Commission shall be empowered to adopt delegated acts in accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, in order to include active substances provided that there is evidence that they do not give rise to concern according to paragraph 2 of this Article.
Na Komisijo se prenese pooblastilo za sprejetje delegiranih aktov v skladu s členom 83 o spremembi Priloge I po prejemu mnenja Agencije, da bi se vključile aktivne snovi, pod pogojem, da obstajajo dokazi, da aktivne snovi ne vzbujajo zaskrbljenosti v skladu z odstavkom 2 tega člena.
Active substances give rise to concern where:
Aktivne snovi vzbujajo zaskrbljenost, če:
they meet the criteria for classification according to Regulation (EC) No 1272/2008 as:
izpolnjujejo merila za razvrstitev v skladu z Uredbo (ES) št. 1272/2008 kot:
explosive/highly flammable,
eksplozivne/zelo vnetljive,
organic peroxide,
organski peroksid,
acutely toxic of category 1, 2 or 3,
akutno toksične kategorije 1, 2 ali 3,
corrosive of category 1A, 1B or 1C,
jedke kategorije 1A, 1B ali 1C,
respiratory sensitiser,
povzročitelji preobčutljivosti dihal,
skin sensitiser,
povzročitelji preobčutljivosti kože,
germ cell mutagen of category 1 or 2;
mutageni za zarodne celice kategorije 1 ali 2,
carcinogen of category 1 or 2,
rakotvorne kategorije 1 ali 2,
human reproductive toxicant of category 1 or 2 or with effects on or via lactation,
strupene za razmnoževanje ljudi kategorije 1 ali 2 ali z učinki na dojenje ali prek dojenja,
specific target organ toxicant by single or repeated exposure, or
strupene snovi za posamezne organe ob enkratni ali ponavljajoči se izpostavljenosti ali
toxic to aquatic life of acute category 1;
strupene za življenje v vodi akutne kategorije 1;
they fulfil any of the substitution criteria set out in Article 10(1); or
izpolnjujejo katero koli od meril za zamenjavo iz člena 10(1) ali
they have neurotoxic or immunotoxic properties.
imajo nevrotoksične ali imunotoksične lastnosti.
Active substances also give rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information.
Aktivne snovi vzbujajo zaskrbljenost, tudi če ni izpolnjeno nobeno od specifičnih meril iz točk (a) do (c), kadar je na podlagi zanesljivih informacij mogoče utemeljeno dokazati stopnjo zaskrbljenosti, enakovredno tisti iz točk (a) do (c).
The Commission shall also be empowered to adopt delegated acts in accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, in order to restrict or to remove the entry for an active substance if there is evidence that biocidal products containing that substance do not, in certain circumstances, satisfy the conditions set out in paragraph 1 of this Article or in Article 25.
Na Komisijo se prenese pooblastilo za sprejetje delegiranih aktov v skladu s členom 83 o spremembi Priloge I po prejemu mnenja Agencije, da bi se omejil ali odstranil vnos za aktivno snov, če obstajajo dokazi, da biocidni proizvod, ki to snov vsebuje, v določenih okoliščinah ne izpolnjuje pogojev iz odstavka 1 tega člena ali člena 25.
Where imperative grounds of urgency so require, the procedure provided for in Article 84 shall apply to delegated acts adopted pursuant to this paragraph.
Kadar to zahtevajo nujni razlogi, se za delegirane akte, sprejete v skladu s tem odstavkom, uporabi postopek iz člena 84.
The Commission shall apply paragraph 1 or 3 at its own initiative or at the request of an economic operator or a Member State providing the necessary evidence as referred to in those paragraphs.
Komisija uporabi odstavek 1 ali 3 na lastno pobudo ali na zahtevo gospodarskega subjekta ali države članice, ki predloži potrebne dokaze, navedene v teh dveh odstavkih.
Whenever the Commission amends Annex I it shall adopt a separate delegated act in respect of each substance.
Kadar Komisija spremeni Prilogo I, sprejme delegirani akt za vsako snov posebej.
The Commission may adopt implementing acts further specifying the procedures to be followed with respect to an amendment of Annex I. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).
Komisija lahko sprejme izvedbene akte, s katerimi se podrobneje določijo postopki v zvezi s spremembo Priloge I. Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 82(3).
NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS
NACIONALNA DOVOLJENJA ZA BIOCIDNE PROIZVODE
Applicants wishing to apply for a national authorisation in accordance with Article 17 shall submit an application to the receiving competent authority.
Vlagatelji, ki želijo vložiti vlogo za nacionalno dovoljenje v skladu s členom 17, vložijo vlogo pri pristojnem organu prejemniku.
The receiving competent authority shall 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.
Pristojni organ prejemnik vlagatelja obvesti o pristojbinah, ki se plačujejo v skladu s členom 80(2), in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
Upon receipt of the fees payable under Article 80(2), the receiving competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 80(2), pristojni organ prejemnik sprejme vlogo in vlagatelja o tem obvesti ter navede datum sprejema.
Within 30 days of acceptance, the receiving competent authority shall validate the application if it complies with the following requirements:
V 30 dneh po sprejetju pristojni organ prejemnik validira vlogo, če ta izpolnjuje naslednje zahteve:
the relevant information referred to in Article 20 has been submitted; and
ustrezne informacije iz člena 20 so bile predložene in
the applicant states that it has not applied to any other competent authority for a national authorisation for the same biocidal product for the same use(s).
vlagatelj izjavi, da vloge za nacionalno dovoljenje za enak biocidni proizvod za enako uporabo ali uporabe ni vložil pri nobenem drugem pristojnem organu.
In the context of the validation referred to in the first subparagraph, the receiving competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
Pristojni organ prejemnik v okviru validacije iz prvega pododstavka ne opravi ocene kakovosti ali ustreznosti predloženih podatkov ali utemeljitev.
Where 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.
Če pristojni organ prejemnik meni, da je vloga nepopolna, vlagatelja obvesti o dodatnih informacijah, potrebnih za validacijo vloge, in določi razumen rok za predložitev teh informacij.
The receiving 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 requirements laid down in paragraph 2.
Pristojni organ prejemnik v 30 dneh po prejemu dodatnih informacij validira vlogo, če odloči, da predložene dodatne informacije zadostujejo za izpolnitev zahtev iz odstavka 2.
The receiving competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.
Če vlagatelj zahtevanih informacij ne predloži v roku, pristojni organ prejemnik vlogo zavrne in vlagatelja ustrezno obvesti.
Where the Register for Biocidal Products referred to in Article 71 shows that a competent authority other than the receiving competent authority is examining an application relating to the same biocidal product or has already authorised the same biocidal product, the receiving competent authority shall decline to evaluate the application.
Če je iz registra biocidnih proizvodov iz člena 71 razvidno, da pristojni organ, ki ni pristojni organ prejemnik, preučuje vlogo za isti biocidni proizvod ali je že izdal dovoljenje za isti biocidni proizvod, pristojni organ prejemnik zavrne ocenjevanje vloge.
In that event, the receiving competent authority shall inform the applicant of the possibility of seeking mutual recognition in accordance with Article 33 or 34.
V tem primeru pristojni organ prejemnik vlagatelja obvesti o možnosti medsebojnega priznanja v skladu s členom 33 ali 34.
If paragraph 3 does not apply and the receiving competent authority considers that the application is complete, it shall validate the application and without delay inform the applicant accordingly, indicating the date of the validation.
Če se odstavek 3 ne uporablja in pristojni organ prejemnik meni, da je vloga popolna, jo validira in nemudoma o tem obvesti vlagatelja ter navede datum validacije.
The receiving competent authority shall, within 365 days of the validation of an application in accordance with Article 29, decide whether to grant an authorisation in accordance with Article 19.
Pristojni organ prejemnik v 365 dneh po validaciji vloge v skladu s členom 29 sprejme odločitev o izdaji dovoljenja v skladu s členom 19.
It shall take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.
Pri tem upošteva rezultate primerjalne ocene, ki se opravi v skladu s členom 23, če je primerno.
Where it appears that additional information is necessary to carry out the evaluation, the receiving competent authority shall ask the applicant to submit such information within a specified time limit.
Če se izkaže, da so za izvedbo ocene potrebne dodatne informacije, pristojni organ prejemnik od vlagatelja zahteva, da v določenem roku predloži take informacije.
The 365-day period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received.
Obdobje 365 dni iz odstavka 1 se prekine od dneva izdaje zahtevka do dneva prejema informacij.
Within the 365-day period referred to in paragraph 1, the receiving competent authority shall:
V obdobju 365 dni iz odstavka 1 pristojni organ prejemnik:
draft a report summarising the conclusions of its assessment and the reasons for authorising the biocidal product or for refusing to grant an authorisation (the ‘assessment report’);
sestavi poročilo, v katerem povzame ugotovitve ocenjevanja in razloge za izdajo dovoljenja za biocidni proizvod ali za zavrnitev njegove izdaje (v nadaljnjem besedilu: poročilo o oceni);
send an electronic copy of the draft assessment report to the applicant and provide it with the opportunity to submit comments within 30 days; and
vlagatelju pošlje elektronsko kopijo osnutka poročila o oceni in mu da možnost, da v 30 dneh predloži pripombe, in
take due account of those comments when finalising its assessment.
te pripombe ustrezno upošteva pri končni oceni.
Renewal of a national authorisation
Podaljšanje nacionalnega dovoljenja
An application by or on behalf of an authorisation holder wishing to seek the renewal of a national authorisation for one or more product-types shall be submitted to the receiving competent authority at least 550 days before the expiry date of the authorisation.
Vloga s strani ali v imenu imetnika dovoljenja, ki želi podaljšati nacionalno dovoljenje za eno ali več vrst proizvodov, se vloži pri pristojnem organu prejemniku najmanj 550 dni pred iztekom veljavnosti dovoljenja.
Where renewal is sought for more than one product-type, the application shall be submitted at least 550 days before the earliest expiry date.
Za podaljšanje dovoljenja za več kot eno vrsto proizvoda se vloga vloži najmanj 550 dni pred iztekom tistega dovoljenja, ki se izteče najprej.
The receiving competent authority shall renew the national authorisation, provided that the conditions set out in Article 19 are still satisfied.
Pristojni organ prejemnik podaljša nacionalno dovoljenje, če so pogoji iz člena 19 še vedno izpolnjeni.
When applying for renewal, the applicant shall submit:
Ob vložitvi vloge za podaljšanje vlagatelj predloži:
without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial authorisation 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 pridobljeni po prvotnem dovoljenju ali predhodnem podaljšanju, kakor je primerno, in
its assessment of whether the conclusions of the initial or previous assessment of the biocidal product remain valid and any supporting information.
svojo oceno o tem, ali so ugotovitve iz prvotne ali predhodne ocene biocidnega proizvoda še naprej veljavne, in ustrezna dokazila.
The receiving competent authority shall 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.
Pristojni organ prejemnik vlagatelja obvesti o pristojbinah, ki se plačujejo v skladu s členom 80(2), in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
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 authorisation or, as appropriate, the previous renewal, the receiving competent authority shall, within 90 days of accepting an application in accordance with paragraph 4, 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 dovoljenje ali predhodnega podaljšanja, kakor je primerno, pristojni organ prejemnik v 90 dneh po prejemu vloge v skladu z odstavkom 4 odloči, ali je glede na sedanja znanstvena spoznanja potrebna popolna ocena vloge za podaljšanje, ob upoštevanju vseh vrst proizvodov, za katere se zahteva podaljšanje.
Where the receiving competent authority decides that a full evaluation of the application is necessary, it shall decide on the renewal of the authorisation after carrying out an evaluation of the application in accordance with paragraphs 1, 2 and 3 of Article 30.
Če pristojni organ prejemnik odloči, da je potrebna popolna ocena vloge, odločitev o podaljšanju dovoljenja sprejme po izvedbi ocene vloge v skladu z odstavki 1, 2 in 3 člena 30.
Where the receiving competent authority decides that a full evaluation of the application is not necessary, it shall decide on the renewal of the authorisation within 180 days of accepting the application in accordance with paragraph 4 of this Article.
Če pristojni organ prejemnik odloči, da popolna ocena vloge ni potrebna, odločitev o podaljšanju dovoljenja sprejme v 180 dneh po prejemu vloge v skladu z odstavkom 4 tega člena.
Where, for reasons beyond the control of the holder of a national authorisation, no decision is taken on the renewal of that authorisation before its expiry, the receiving competent authority shall grant a renewal for the period necessary to complete the evaluation.
Kadar se zaradi razlogov, na katere imetnik nacionalnega dovoljenja ne more vplivati, odločitev o podaljšanju tega dovoljenja ne sprejme pred njegovim iztekom veljavnosti, pristojni organ prejemnik odobri podaljšanje za obdobje, ki je potrebno za dokončanje ocene.
MUTUAL RECOGNITION PROCEDURES
POSTOPKI MEDSEBOJNEGA PRIZNAVANJA DOVOLJENJ
Authorisation through mutual recognition
Izdaja dovoljenja na podlagi medsebojnega priznavanja dovoljenj
Applications for mutual recognition of a national authorisation shall be made in accordance with the procedures set out in Article 33 (mutual recognition in sequence) or Article 34 (mutual recognition in parallel).
Vloge za medsebojno priznavanje nacionalnih dovoljenj so vložene v skladu s postopki iz člena 33 (zaporedno medsebojno priznavanje dovoljenj) ali člena 34 (vzporedno medsebojno priznavanje dovoljenj).
Without prejudice to Article 37, all Member States receiving applications for mutual recognition of a national authorisation for a biocidal product shall, in accordance with and subject to the procedures set out in this Chapter, authorise the biocidal product under the same terms and conditions.
Brez poseganja v člen 37 vse države članice, ki prejmejo vloge za medsebojno priznavanje nacionalnega dovoljenja za biocidni proizvod, v skladu s tem poglavjem in ob upoštevanju postopkov iz tega poglavja izdajo dovoljenje za biocidni proizvod pod enakimi določili in pogoji.
Mutual recognition in sequence
Zaporedno medsebojno priznavanje dovoljenj
Applicants wishing to seek the mutual recognition in sequence, in one or more Member States (‘the Member States concerned’), of the national authorisation of a biocidal product already granted in another Member State in accordance with Article 17 (‘the reference Member State’) shall submit an application to each of the competent authorities of the Member States concerned containing, in each case, a translation of the national authorisation granted by the reference Member State into such official languages of the Member State concerned as it may require.
Vlagatelji, ki želijo v eni ali več državah članicah (v nadaljnjem besedilu: zadevne države članice) zaprositi za zaporedno medsebojno priznanje nacionalnega dovoljenja za biocidni proizvod, za katerega je druga država članica že izdala dovoljenje v skladu s členom 17 (v nadaljnjem besedilu: referenčna država članica), pri pristojnih organih vsake od zadevnih držav članic vložijo vlogo, ki v vsakem primeru vsebuje prevode nacionalnega dovoljenja, ki ga je izdala referenčna država članica, v takšne uradne jezike zadevne države članice, kot ta to lahko zahteva.
The competent authorities of the Member States concerned shall inform the applicant of the fees payable under Article 80 and shall reject the application if the applicant fails to pay the fees within 30 days.
Pristojni organi zadevnih držav članic vlagatelja obvestijo o pristojbinah, ki se plačujejo v skladu s členom 80, in vlogo zavrnejo, če vlagatelj teh pristojbin ne plača v 30 dneh.
They shall inform the applicant and the other competent authorities accordingly.
Pristojni organi zadevnih držav članic vlogo zavrnejo in ustrezno obvestijo vlagatelja in druge pristojne organe.
Upon receipt of the fees payable under Article 80, the competent authorities of the Member States concerned shall accept the application and inform the applicant indicating the date of acceptance.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 80, pristojni organi zadevnih držav članic sprejme vlogo in vlagatelja obvesti o datumu prejema.
Within 30 days of acceptance referred to in paragraph 1, the Member States concerned shall validate the application and inform the applicant accordingly, indicating the date of the validation.
Zadevne države članice v 30 dneh po sprejemu iz odstavka 1 validirajo vlogo in vlagatelja o tem obvestijo ter navedejo datum validacije.
Within 90 days of validating the application, and subject to Articles 35, 36 and 37, the Member States concerned shall agree on the summary of biocidal product characteristics referred to in Article 22(2) and shall record their agreement in the Register for Biocidal Products.
Zadevne države članice se v 90 dneh po validaciji vloge in ob upoštevanju členov 35, 36 in 37 dogovorijo o povzetku značilnosti biocidnega proizvoda iz člena 22(2), njihov dogovor pa vnesejo v register biocidnih proizvodov.
Within 30 days of reaching agreement, each of the Member States concerned shall authorise the biocidal product in conformity with the agreed summary of biocidal product characteristics.
V 30 dneh po doseženem dogovoru vsaka zadevna država članica izda dovoljenje za biocidni proizvod v skladu z dogovorjenim povzetkom značilnosti biocidnega proizvoda.
Without prejudice to Articles 35, 36, and 37, if no agreement is reached within the 90-day period referred to in the second subparagraph of paragraph 2, each Member State that agrees to the summary of biocidal product characteristics referred to in paragraph 2, may authorise the product accordingly.
Če v 90-dnevnem obdobju iz drugega pododstavka odstavka 2 ni dosežen dogovor, lahko vsaka država članica, ki se dogovori o povzetku značilnosti biocidnega proizvoda iz odstavka 2, brez poseganja v člene 35, 36 in 37 v skladu s tem izda dovoljenje za proizvod.
Mutual recognition in parallel
Vzporedno medsebojno priznavanje dovoljenj
Applicants wishing to seek the mutual recognition in parallel of a biocidal product which has not yet been authorised in accordance with Article 17 in any Member State shall submit to the competent authority of the Member State of its choice (‘the reference Member State’) an application containing:
Vlagatelji, ki želijo zaprositi za vzporedno medsebojno priznanje biocidnega proizvoda, za katerega v skladu s členom 17 še ni bilo izdano dovoljenje v nobeni državi članici, pri pristojnemu organu države članice, ki jo sami izberejo (v nadaljnjem besedilu: referenčna država članica), vložijo vlogo, ki vsebuje:
the information referred to in Article 20;
informacije iz člena 20;
a list of all other Member States where a national authorisation is sought (‘the Member States concerned’).
seznam vseh drugih držav članic, v katerih želijo pridobiti nacionalno dovoljenje (v nadaljnjem besedilu: zadevne države članice).
The reference Member State shall be responsible for the evaluation of the application.
Referenčna država članica je pristojna za oceno vloge.
The applicant shall, at the same time as submitting the application to the reference Member State in accordance with paragraph 1, submit to the competent authorities of each of the Member States concerned an application for mutual recognition of the authorisation for which it has applied to the reference Member State.
Vlagatelj ob vložitvi vloge v referenčni državi članici v skladu z odstavkom 1 hkrati pri pristojnih organih vseh zadevnih držav članic vloži vlogo za medsebojno priznanje dovoljenja, za katerega je vložil vlogo pri referenčni državi članici.
This application shall contain:
Ta vloga vsebuje:
the names of the reference Member State and of the Member States concerned;
imena referenčne države članice in držav članic priznanja;
the summary of biocidal product characteristics referred to in Article 20(1)(a)(ii) in such official languages of the Member States concerned as they may require.
predlog povzetka značilnosti biocidnega proizvoda iz člena 20(1)(a)(ii) v zahtevanih uradnih jezikih zadevnih držav članic, kot te to lahko zahtevajo.
The competent authorities of the reference Member State and of the Member States concerned shall inform the applicant of the fees payable in accordance with Article 80 and shall reject the application if the applicant fails to pay the fees within 30 days.
Pristojni organi referenčne države članice in zadevnih držav članic vlagatelja obvestijo o pristojbinah, ki se plačujejo v skladu s členom 80, in vlogo zavrnejo, če vlagatelj teh pristojbin ne plača v 30 dneh.
Upon receipt of the fees payable under Article 80, the competent authorities of the reference Member State and of the Member States concerned shall accept the application and inform the applicant indicating the date of acceptance.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 80, pristojni organi referenčne države članice in zadevnih držav članic sprejmejo vlogo ter vlagatelja obvestijo in navedejo datum sprejema.
The reference Member State shall validate the application in accordance with Article 29(2) and (3) and inform the applicant and the Member States concerned accordingly.
Referenčna država članica validira vlogo v skladu s členom 29(2) in (3) ter ustrezno obvesti vlagatelja in zadevne države članice.