natgillin/translations-raw huggingface dataset:
Če se sprejme odločitev, da se uporabe biocidnega proizvoda v skladu z odstavkom 3 ne dovoli ali se jo omeji, začne navedeni preklic ali sprememba dovoljenja učinkovati pet let po tej odločitvi.
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 that decision.
Če pa se rok za odobritev aktivne snovi, ki je možna snov za zamenjavo, pred tem izteče, začne preklic dovoljenja učinkovati na ta zgodnejši datum.
However, where the approval of the active substance which is a candidate for substitution expires on an earlier date, the cancellation of the authorisation shall take effect on that earlier date.
Če se sprejme odločitev, da se uporabe biocidnega proizvoda v skladu z odstavkom 3 ne dovoli ali se jo omeji, začne navedeni preklic ali sprememba dovoljenja učinkovati tri leta po tej odločitvi.
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 that decision.
(Ponovna vložitev predloga spremembe 128 iz prve obravnave.)
(Reinstatement of amendment 128 from first reading.)
Ni sprejemljivo, da bi lahko biocidni proizvod na trgu ostal 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.
Komisija pripravi tehnična navodila za lažje izvajanje tega poglavja, zlasti členov 21(2) in 22(3).
The Commission shall draw up technical guidance notes to facilitate the implementation of this Chapter and, in particular, Articles 21(2) and 22(3).
Komisija pripravi tehnična navodila za lažje izvajanje tega poglavja, zlasti členov 18(2)(d) in (da), 21(2) in 22(3).
The Commission shall draw up technical guidance notes to facilitate the implementation of this Chapter and, in particular, Articles 18(2)(d) and (da), 21(2) and 22(3).
Zaenkrat ni dogovorjene znanstvene opredelitve za koncept kumulativnih ali sinergijskih učinkov, niti ni dogovorjene metodologije.
There is neither a currently agreed scientific definition for the concept of cumulative or synergistic effects, nor an agreed methodology.
Te opredelitve in metodologije mora sprejeti Komisija prek tehničnih navodil pred začetkom veljavnosti te uredbe.
These definitions and methodologies need to be adopted by the Commission via technical guidance notes, prior to entry into force of the Regulation.
Člen 24 – odstavek 1 – točka b a (novo)
Article 24 – paragraph 1 – point b a (new)
(ba) biocidni proizvod ne vsebuje nanomateriala;
(ba) the biocidal product does not contain a nanomaterial;
(Ponovna vložitev predloga spremembe 103 iz prve obravnave.)
(Reinstatement of amendment 103 of first reading.)
Glede na to, da zaenkrat ni ustrezne ocene tveganja za nanomateriale, se zanje ne bi smel uporabljati poenostavljeni postopek izdaje dovoljenja.
In light of the current lack of appropriate risk assessment of nanomaterials, they should not qualify for the simplified authorisation procedure.
Člen 24 – točka c a (novo)
Article 24 – point c a (new)
(ca) biocidni proizvod ustreza merilom iz člena 18(1)(b)(ii) do (iv) in
(ca) the biocidal product meets the critieria laid down in Article 18(1)(b)(ii) to (iv); and
Ta predlog spremembe zagotavlja, da se prihodnja uporaba aktivnih snovi ali biocidnih proizvodov v tretiranih izdelkih obravnava že v fazi odobritve aktivnih snovi ali dovoljenja za biocidne proizvode.
This amendment ensures that future use of active substances/biocidal products in treated articles is already considered at the stage of approval of the active substances or authorisation of the biocidal products.
Za uporabo v tretiranih izdelkih se odobrijo samo aktivne snovi in biocidni proizvodi, ki izpolnjujejo pogoje iz člena 18(1) ali člena 24.
Only those active substances/biocidal products fulfilling the conditions of Art. 18(1) or Art. 24 respectively shall be authorised for use in treated articles.
Agencija preveri, če je bila vloga vložena v pravilnem formatu, in nato nemudoma uradno obvesti ocenjevalni pristojni organ , da je vloga na voljo v registru biocidnih proizvodov .
The Agency shall, after checking that it has been submitted in the correct format, notify the evaluating competent authority without delay that the application is available via the Register for Biocidal Products.
Agencija preveri, ali je bila vloga vložena v pravilnem formatu, in nemudoma uradno obvesti ocenjevalni pristojni organ.
The Agency shall check that it has been submitted in the correct format and notify the evaluating competent authority without delay.
Sklic na register biocidnih proizvodov v tej določbi je sedaj odveč.
The reference to the Register for Biocidal Products in this provision is now redundant.
Potem ko je Svet spremenil člen 70, ta sedaj jasno določa, da je register biocidnih proizvodov edini način izmenjave informacij glede uporabe, ter nudi indikacije, kaj naj se vnese v register in kdaj.
Article 70, as modified by the Council, now makes clear that the Biocidal Products Register is the exclusive means of exchanging information regarding applications and provides indications as to what should be uploaded into the Register and when.
Člen 25 – odstavek 2 – pododstavek 2
Article 25 – paragraph 2 – subparagraph 2
Ocenjevalni pristojni organ vlagatelja obvesti o pristojbinah, ki se plačujejo na podlagi člena 79 in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
The evaluating competent authority shall inform the applicant of the fees payable under Article 79 and shall reject the application if the applicant fails to pay the fees within 30 days.
Pristojni organ prejemnik ustrezno obvesti vlagatelja.
It shall inform the applicant accordingly.
Ocenjevalni pristojni organ vlagatelja obvesti o pristojbinah, ki se plačujejo na podlagi člena 79(2) in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
The evaluating competent authority shall inform the applicant of the fees payable under Article 79(2) and shall reject the application if the applicant fails to pay the fees within 30 days.
Namen predloga spremembe je pojasniti besedilo in zagotoviti večjo skladnost (tako znotraj besedila kot tudi z drugimi zakonodajnimi akti).
The aim of this amendment is to clarify the text and ensure greater consistency (both within the text itself and with other legislative acts).
Člen 25 – odstavek 2 – pododstavek 3
Article 25 – paragraph 2 – subparagraph 3
Po prejemu pristojbin, ki se plačujejo v skladu s členom 79 , ocenjevalni pristojni organ sprejme vlogo in o tem ustrezno obvesti vlagatelja.
Upon receipt of the fees payable under Article 79 , the evaluating competent authority shall accept the application and inform the applicant accordingly.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 79(2), ocenjevalni pristojni organ sprejme vlogo in o tem ustrezno obvesti vlagatelja.
Upon receipt of the fees payable under Article 79(2) , the evaluating competent authority shall accept the application and inform the applicant accordingly.
Ocenjevalni pristojni organ ob odobritvi biocidnega proizvoda v skladu z odstavkom 3 ali 4 o tem nemudoma prek registra biocidnih proizvodov ustrezno obvesti vlagatelja, Agencijo in druge pristojne organe ter navede točen datum odobritve.
On authorising the biocidal product in accordance with paragraph 3 or 4, the evaluating competent authority shall without delay inform the applicant, the Agency and other competent authorities accordingly via the Register for Biocidal Products indicating the exact date of the authorisation.
Biocidni proizvod, odobren v skladu s členom 25, je lahko dostopen na trgu v vseh državah članicah brez medsebojnega priznavanja.
A biocidal product authorised in accordance with Article 25 may be made available on the market in all Member States without the need for mutual recognition.
Vendar imetnik dovoljenja uradno obvesti vsako državo članico, preden biocidni proizvod da na trg na ozemlju te države članice, in na oznaki proizvoda uporabi uradni jezik ali uradne jezike te države članice, razen če ta določi drugače.
However, the authorisation holder shall notify each Member State before placing the biocidal product on the market within the territory of that Member State and shall use the official language or languages of that Member State in the product's labelling, unless that Member State provides otherwise.
Biocidni proizvod, odobren v skladu s členom 25, se sme dati na trg v vseh državah članicah brez medsebojnega priznavanja.
A biocidal product authorised in accordance with Article 25 may be placed on the market in all Member States without the need for mutual recognition.
Vendar imetnik dovoljenja uradno obvesti vsako državo članico 30 dni, preden biocidni proizvod da na trg na ozemlju te države članice, in na oznaki proizvoda uporabi uradni jezik ali uradne jezike te države članice, razen če ta določi drugače.
However, the authorisation holder shall notify each Member State 30 days before placing the biocidal product on the market within the territory of that Member State and shall use the official language or languages of that Member State in the product's labelling, unless that Member State provides otherwise.
Ker je cilj poenostavljenega postopka odobritve zagotovilo, da določeni proizvodi, ki predstavljajo manjše tveganje za okolje in človeško zdravje, hitreje pridejo na trg, je rok za obvestilo dovolj kratek, da s tem povezanih postopkov ne podaljšuje po nepotrebnem.
As the objective of the simplified authorisation procedure is to ensure that certain products presenting lower risks to the environment and human health can be put quickly on the market, the deadline for the notification is sufficiently short in order not to prolong unnecessarily the related procedures.
Hkrati državam članicam daje dovolj časa, da po potrebi ukrepajo.
At the same time, it gives Member States enough time to act if necessary.
Postopke za sodelovanje bi lahko obravnavali z izvedbenimi ukrepi, kot je predvideno v predlogu spremembe.
These procedural arrangements could be addressed through implementing measures as foreseen in the amendment.
Če pristojni organ prejemnik odloči, da bo izdal dovoljenje, v register biocidnih proizvodov vnese naslednje informacije:
Where the receiving competent authority decides to grant an authorisation it shall enter the following information in the Register for Biocidal Products:
(a) povzetek značilnosti biocidnega proizvoda iz člena 21(2);
(a) the summary of biocidal product characteristics referred to in Article 21(2);
(b) končno poročilo o oceni;
(b) the final assessment report;
(c) kakršne koli pogoje, ki se uvedejo za dostopnost na trgu ali uporabo biocidnega proizvoda.
(c) any terms or conditions imposed on the making available on the market or use of the biocidal product.
Če pristojni organ prejemnik odloči, da ne bo izdal dovoljenja, v register biocidnih proizvodov vnese končno poročilo o oceni.
Where the receiving competent authority decides not to grant an authorisation it shall enter the final assessment report in the Register for Biocidal Products.
V obeh primerih uradno obvesti vlagatelja o svoji odločitvi in mu pošlje elektronsko kopijo končnega poročila o oceni.
In either case, it shall notify the applicant of its decision together with an electronic copy of the final assessment report.
Člen 30 – odstavek 3 – točka a
Article 30 – paragraph 3 – point a
(a) seznam vseh ustreznih podatkov , ki jih je pridobil po prvotnem dovoljenju ali predhodnem podaljšanju, kakor je primerno , in
(a) a list of all relevant data that it has generated since the initial authorisation or, as appropriate, previous renewal; and
(a) brez poseganja v člen 20(1) vse ustrezne podatke, ki se zahtevajo v skladu s členom 19 in so bili ustvarjeni po prvotnem dovoljenju ali predhodnem podaljšanju, ali pismo o dostopu do teh podatkov, kakor je primerno ; in
(a) without prejudice to Article 20(1), all relevant data required under Article 19 that has been generated since the initial authorisation or, as appropriate, previous renewal , or a letter of access to such data ; and
S sklicevanjem na člena 19 in 20 je besedilo bolj natančno.
References made to Article 19 and 20 make the text more precise.
Da bi dosegli varstvo podatkov, je treba podatke dejansko predložiti.
In order to obtain data protection, it is required that the data is actually submitted.
Možnost, da se predloži pismo o dostopu, bi bilo treba vključiti v to določbo za primere, ko lastnik podatkov ni predlagatelj, ki prosi za obnovitev.
The possibility to submit a letter of access should be included in this provision for cases when the data owner is different from the applicant wishing to seek a renewal.
Člen 30 – odstavek 4 – pododstavek 1
Article 30 – paragraph 4 – subparagraph 1
Pristojni organ prejemnik vlagatelja obvesti o pristojbinah, ki se plačujejo na podlagi člena 79 , in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
The receiving competent authority shall inform the applicant of the fees payable under Article 79 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 na podlagi člena 79(2) , in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
The receiving competent authority shall inform the applicant of the fees payable under Article 79(2) 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 79, pristojni organ prejemnik sprejme vlogo in vlagatelja ustrezno obvesti o datumu sprejetja.
Upon receipt of the fees payable under Article 79 , 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 79(2), pristojni organ prejemnik sprejme vlogo in vlagatelja ustrezno obvesti o datumu sprejetja.
Upon receipt of the fees payable under Article 79(2) , the receiving competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.
Takoj ko pristojni organ prejemnik sprejme odločitev o podaljšanju nacionalnega dovoljenja, posodobi informacije iz člena 29(4) v registru biocidnih proizvodov.
As soon as the receiving competent authority has taken a decision on whether to grant a renewal of a national authorisation, it shall update the information referred to in Article 29(4) in the Register for Biocidal Products.
Vlagatelja uradno obvesti o svoji odločitvi in mu pošlje elektronsko kopijo končnega poročila o oceni.
It shall notify the applicant of its decision together with an electronic copy of the final assessment report.
Pristojni organi zadevnih držav članic vlagatelja obvestijo o pristojbinah, ki se plačujejo na podlagi člena 79 , in vlogo zavrnejo, če vlagatelj teh pristojbin ne plača v 30 dneh .
The competent authorities of the Member States concerned shall inform the applicant of the fees payable under Article 79 and shall reject the application if the applicant fails to pay the fees within 30 days .
Pristojni organi zadevnih držav članic vlogo zavrnejo in ustrezno obvestijo vlagatelja in druge pristojne organe.
They shall inform the applicant and the other competent authorities accordingly.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 79 , pristojni organ zadevnih držav članic sprejme vlogo in vlagatelja obvesti o datumu sprejetja.
Upon receipt of the fees payable under Article 79, the competent authority of the Member States concerned shall accept the application and inform the applicant indicating the date of acceptance.
Pristojni organi zadevnih držav članic vlagatelja obvestijo o pristojbinah, ki se plačujejo na podlagi člena 79(2) , in vlogo zavrnejo, če vlagatelj teh pristojbin ne plača v 60 dneh .
The competent authorities of the Member States concerned shall inform the applicant of the fees payable under Article 79(2) and shall reject the application if the applicant fails to pay the fees within 60 days .
Po prejemu pristojbin, ki se plačujejo v skladu s členom 79(2) , pristojni organ zadevnih držav članic sprejme vlogo in vlagatelja obvesti o datumu sprejetja.
Upon receipt of the fees payable under Article 79(2), the competent authority of the Member States concerned shall accept the application and inform the applicant indicating the date of acceptance.
Besedilo mora vsebovati sklicevanje na člen 79(2), ki je pravilno sklicevanje za pristojbine, plačane državam članicam.
The text should include a reference to Article 79(2), which is the correct reference for fees paid to Member States.
Zadevne države članice se v 90 dneh po validaciji vloge in ob upoštevanju členov 34, 35 in 36 dogovorijo o povzetku značilnosti biocidnega proizvoda, njihov dogovor pa vnesejo v register biocidnih proizvodov.
Within 90 days of validating the application, and subject to Articles 34, 35 and 36, the Member States concerned shall agree on the summary of biocidal product characteristics 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 34, 35 in 36 dogovorijo o povzetku značilnosti biocidnega proizvoda, vključenega v nacionalno dovoljenje, ki ga je izdala referenčna država članica, svoj dogovor pa vnesejo v register biocidnih proizvodov.
Within 90 days of validating the application, and subject to Articles 34,35 and 36, the Member States concerned shall agree on the summary of biocidal product characteristics included in the national authorisation granted by the reference Member State and shall record their agreement in the Register for Biocidal Products.
Če v 90-dnevnem obdobju iz drugega pododstavka ni dosežen dogovor, lahko vsaka država članica, ki se dogovori o značilnostih biocidnega proizvoda iz prvega pododstavka, brez poseganja v člene 34, 35 in 36 svoj dogovor vnese v register biocidnih proizvodov in izda dovoljenje za proizvod v skladu s povzetkom značilnosti biocidnega proizvoda, o katerem se je dogovorila.
Without prejudice to Articles 34, 35, and 36, if agreement is not reached within the 90 day period referred to in the second subparagraph, each Member State which agrees to the biocidal product characteristics referred to in the first subparagraph may register its agreement in the Register of Biocidal Products and authorise the product in conformity with the summary of biocidal product characteristics to which it agreed.
Bistvena je skladnost med Uredbo 1107/2009 in to uredbo.
Consistency between Regulation 1107/2009 and this one is essential.
Glede na to, da določbe o registraciji po območjih iz Uredbe 1107/2009 o fitofarmacevtskih sredstvih izključujejo možnost, da bi ena država članica zadržala postopek izdaje dovoljenja v drugi državi članici, ko bo poročevalka dokončala osnutek vključitve, bi se moralo enako načelo uporabljati v uredbi o biocidih.
Given that the provisions on zonal authorisation in Regulation 1107/2009 on PPP exclude the possibility for one Member State to delay the authorisation procedure in the other Member States once the Draft Inclusion by the Rapporteur has been finalised, the same principle should apply within the Biocides Regulation.
S tem bi preprečili nepotrebne zamude, ki bi lahko ogrozile prednosti postopka medsebojnega priznavanja.
This will allow avoiding unnecessary delays which could jeopardise the benefits of the mutual recognition process.
Postopek se konča, ko se vse zadevne države članice dogovorijo o povzetku značilnosti biocidnega proizvoda ter njihov dogovor vnesejo v register biocidnih proizvodov.
The procedure shall be closed after all the Member States concerned have agreed on the summary of biocidal product characteristics and recorded their agreement in the Register for Biocidal Products.
Postopek iz drugega pododstavka se konča, ko se vse zadevne države članice dogovorijo o povzetku značilnosti biocidnega proizvoda , vključenem v nacionalno dovoljenje, ki ga izda referenčna država članica, skupaj s pogoji za izdajo dovoljenja, ter svoj dogovor vnesejo v register biocidnih proizvodov.
The procedure referred to in paragraph 2 shall be closed after all the Member States concerned have agreed on the summary of biocidal product characteristics included in the national authorisation granted by the reference Member State together with the terms and conditions of the authorisation, and recorded their agreement in the Register for Biocidal Products.
V 30 dneh po koncu postopka vsaka zadevna država članica izda dovoljenje za biocidni proizvod v skladu z dogovorjenim povzetkom značilnosti biocidnega proizvoda.
Within 30 days of closure of the procedure, 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 koncu postopka iz odstavka 3 zadevne države članice izdajo dovoljenje za biocidni proizvod v skladu z dogovorjenim povzetkom značilnosti biocidnega proizvoda.
Within 30 days of closure of the procedure referred to in paragraph 3 , Member States concerned shall authorise the biocidal product in conformity with the agreed summary of biocidal product characteristics.
Člen 33 – odstavek 2 – točka c a (novo)
Article 33 – paragraph 2 – point c a (new)
(ca) predlagane pogoje za izdajo dovoljenja iz člena 21(1) v angleščini.
(ca) the proposed terms and conditions of the authorisation referred to in Article 21(1) in English.
Ker so pogoji za izdajo dovoljenja pomemben del odobritve, jih je treba predlagati in dodati vlogi predlagatelja.
Since the terms and conditions of authorisation constitute an important part of the authorisation, it should be proposed and added to the application by the applicant.
Člen 33 – odstavek 5 a (novo)
Article 33 – paragraph 5 a (new)
Če v 90-dnevnem obdobju iz odstavka 5 ni dosežen dogovor, lahko vsaka država članica, ki se dogovori o povzetku značilnosti biocidnega proizvoda iz odstavka 4, brez poseganja v člene 34, 35 in 36 svoj dogovor vnese v register in izda dovoljenje za proizvod v skladu s povzetkom značilnosti biocidnega proizvoda, o katerem se je dogovorila.
Without prejudice to Articles 34, 35, and 36, if agreement is not reached within the 90 day period referred to in paragraph 5 each Member State which agrees to the summary biocidal product characteristics referred to in paragraph 4 may register its agreement and authorise the product in conformity with the summary of biocidal product characteristics to which it agreed.
Postopek se konča, ko se vse zadevne države članice dogovorijo o povzetku značilnosti biocidnega proizvoda ter dogovor vnesejo v register biocidnih proizvodov.
The procedure shall be closed after all the Member States concerned have agreed the summary of biocidal product characteristics and recorded their agreement in the Register for Biocidal Products.
Postopek se konča, ko se vse zadevne države članice dogovorijo o povzetku značilnosti biocidnega proizvoda , skupaj s pogoji za izdajo dovoljenja, ter dogovor vnesejo v register biocidnih proizvodov.
The procedure shall be closed after all the Member States concerned have agreed the summary of biocidal product characteristics together with the terms and conditions of the authorisation, and recorded their agreement in the Register for Biocidal Products.
V vseh udeleženih državah članicah se uporablja enotna številka dovoljenja.
A single authorisation number shall be used in all the Member States concerned.
Člen 33 – odstavek 7
Article 33 – paragraph 7
V 30 dneh po koncu postopka referenčna država članica in vsaka zadevna država članica izda dovoljenje za biocidni proizvod v skladu z dogovorjenim povzetkom značilnosti biocidnega proizvoda.
Within 30 days of closure of the procedure, the reference Member State and each of the Member States concerned shall authorise the biocidal product in conformity with the agreed summary of biocidal product characteristics.