natgillin/translations-raw huggingface dataset:
Where appropriate, the prospective authorisation holder or its representative shall apply for the establishment of maximum residue limits with respect to active substances contained in a biocidal product in accordance with Regulation (EEC) No 315/93, Regulation (EC) No 396/2005, Regulation (EC) No 470/2009 or Directive 2002/32/EC, or for the establishment of specific migration limits or limits for the residual content in food contact materials with respect to such substances in accordance with Regulation (EC) No 1935/2004.’;
Morebitni imetnik dovoljenja ali njegov zastopnik po potrebi zaprosi za določitev najvišjih mejnih vrednosti ostankov aktivnih snovi v biocidnem proizvodu v skladu z Uredbo (EGS) št. 315/93, Uredbo (ES) št. 396/2005, Uredbo (ES) št. 470/2009 ali Direktivo 2002/32/ES ali za določitev posebnih mejnih vrednosti migracije ali mejnih vrednosti za ostanek v materialih, namenjenih za stik z živili v skladu z Uredbo (ES) št. 1935/2004.“;
in Article 23(3), the introductory part is replaced by the following:
v členu 23(3) se uvodni del nadomesti z naslednjim:
The receiving competent authority or, in the case of a decision on an application for a Union authorisation, the Commission, shall prohibit or restrict the making available on the market or the use of a biocidal product containing an active substance that is a candidate for substitution where a comparative assessment, performed in accordance with the technical guidance notes referred to in Article 24, demonstrates that both of the following criteria are met:’;
Pristojni organ prejemnik ali v primeru odločitve glede vloge za dovoljenje Unije Komisija prepove ali omeji dostopnost na trgu ali uporabo biocidnega proizvoda, ki vsebuje aktivno snov kot možno snov za zamenjavo, če primerjalna ocena, izvedena v skladu s tehničnimi navodili iz člena 24, dokazuje, da sta izpolnjeni obe naslednji merili:“;
in Article 34(4), the second subparagraph is replaced by the following:
v členu 34(4) se drugi pododstavek nadomesti z naslednjim:
‘Within 365 days of validating an application, the reference Member State shall evaluate the application and draft an assessment report in accordance with Article 30 and shall send its assessment report and the summary of biocidal product characteristics to the Member States concerned and to the applicant.’;
„Referenčna država članica v 365 dneh od validacije vloge v skladu s členom 30 oceni vlogo in sestavi poročilo o oceni ter ga skupaj s povzetkom značilnosti biocidnega proizvoda pošlje zadevnim državam članicam in vlagatelju.“;
Article 35(3) is replaced by the following:
člen 35(3) se nadomesti z naslednjim:
The procedure shall then be considered to be closed and the reference Member State and each of the Member States concerned shall authorise the biocidal product in accordance with Article 33(3) or 34(6) as appropriate.’;
Postopek se nato šteje za končanega ter referenčna država članica in vsaka zadevna država članica izda dovoljenje v skladu s členom 33(3) ali 34(6), kakor je ustrezno.“;
in Article 37(3), the second subparagraph is replaced by the following:
v členu 37(3) se drugi pododstavek nadomesti z naslednjim:
‘While the procedure under this Article is ongoing, the Member States’ obligation to authorise a biocidal product within three years of the date of approval, referred to in the first subparagraph of Article 89(3), shall be temporarily suspended.’;
„V času trajanja postopka iz tega člena se obveznost države članice, da izda dovoljenje za biocidni proizvod v treh letih od dneva odobritve iz prvega pododstavka člena 89(3), začasno prekine.“;
in Article 45(1), the second subparagraph is deleted;
v členu 45(1) se črta drugi pododstavek;
Notwithstanding Article 89, where the competent authority or, in the case of a biocidal product authorised at Union level, the Commission, cancels or amends an authorisation or decides not to renew it, it shall grant a period of grace for the making available on the market and use of existing stocks, except in cases where continued making available on the market or use of the biocidal product would constitute an unacceptable risk to human health, animal health or the environment.
Kadar pristojni organ ali v primeru biocidnega proizvoda, odobrenega na ravni Unije, Komisija prekliče ali spremeni dovoljenje ali odloči, da ga ne bo obnovila, ne glede na člen 89 odobri prehodno obdobje za dostopnost na trgu in uporabo obstoječih zalog, razen v primerih, kadar bi nadaljnja dostopnost na trgu ali uporaba biocidnega proizvoda pomenila nesprejemljivo tveganje za zdravje človeka, zdravje živali ali okolje.
The period of grace shall not exceed 180 days for the making available on the market and an additional maximum period of 180 days for the use of existing stocks of the biocidal products concerned.’;
Prehodno obdobje ne sme biti daljše od 180 dni za dostopnost na trgu in dodatnih največ 180 dni za uporabo obstoječih zalog zadevnega biocidnega proizvoda.“;
in Article 53(1), the first subparagraph is replaced by the following:
v členu 53(1) se prvi pododstavek nadomesti z naslednjim:
By way of derogation from Article 17, a competent authority of a Member State (“Member State of introduction”) shall, at the request of the applicant, grant a parallel trade permit for a biocidal product that is authorised in another Member State (“Member State of origin”) to be made available on the market and used in the Member State of introduction, if it determines in accordance with paragraph 3 that the biocidal product is identical to a biocidal product already authorised in the Member State of introduction (“the reference product”).’;
Z odstopanjem od člena 17 pristojni organ države članice (v nadaljnjem besedilu: država članica vnosa) na zahtevo vlagatelja izda dovoljenje za vzporedno trgovanje z biocidnim proizvodom, za katerega je bilo izdano dovoljenje v drugi državi članici (v nadaljnjem besedilu: država članica porekla), zaradi dostopnosti na trgu in uporabe v državi članici vnosa, če v skladu z odstavkom 3 ugotovi, da je biocidni proizvod identičen biocidnemu proizvodu, ki je že dovoljen v državi članici vnosa (v nadaljnjem besedilu: referenčni proizvod).“;
Article 54 is amended as follows:
člen 54 se spremeni:
Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence (“the applicant”) shall submit an application to the Agency.’;
Kadar je treba ugotoviti tehnično ekvivalenco aktivnih snovi, oseba, ki jo želi ugotoviti (v nadaljnjem besedilu: vlagatelj), vloži vlogo pri Agenciji.“;
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 jih vlagatelj ne plača v 30 dneh.
It shall inform the applicant accordingly.’;
O tem ustrezno obvesti vlagatelja.“;
in Article 56(1), the first subparagraph is replaced by the following:
v členu 56(1) se prvi pododstavek nadomesti z naslednjim:
By way of derogation from Article 17, an experiment or a test for the purposes of scientific or product and process-orientated research and development involving an unauthorised biocidal product or a non-approved active substance intended exclusively for use in a biocidal product (“experiment” or “test”) may take place only under the conditions provided for in this Article.’;
Z odstopanjem od člena 17 se lahko poskus ali preskus, namenjen za znanstvene ali v proizvod in proces usmerjene raziskave ali razvoj, ki vključuje biocidni proizvod, za katerega ni bilo izdano dovoljenje, ali neodobreno aktivno snov, ki je namenjena izključno za uporabo v biocidnem proizvodu (v nadaljnjem besedilu: poskus ali preskus), izvede le pod pogoji, določenimi v tem členu.“;
in Article 58(3), the introductory part is replaced by the following:
v členu 58(3) se uvodni del nadomesti z naslednjim:
The person responsible for the placing on the market of a treated article shall ensure that the label provides the information listed in the second subparagraph, where:’;
Oseba, ki je odgovorna za dajanje tretiranega izdelka na trg, zagotovi, da so v oznaki navedene informacije, naštete v drugem pododstavku, pri čemer:“;
in Article 60(3), the first and second subparagraphs are replaced by the following:
v členu 60(3) se prvi in drugi pododstavek nadomestita z naslednjim:
The protection period for data submitted with a view to the authorisation of a biocidal product containing only existing active substances shall end 10 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5).
Obdobje varovanja podatkov, predloženih zaradi izdaje dovoljenja za biocidni proizvod, ki vsebuje le obstoječe aktivne snovi, se izteče 10 let po prvem dnevu v mesecu po sprejetju prve odločitve o izdaji dovoljenja za proizvod v skladu s členom 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) ali 44(5).
The protection period for data submitted with a view to the authorisation of a biocidal product containing a new active substance shall end 15 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5).’;
Obdobje varovanja podatkov, predloženih zaradi izdaje dovoljenja za biocidni proizvod, ki vsebuje novo aktivno snov, se izteče 15 let po prvem dnevu v mesecu po sprejetju prve odločitve o izdaji dovoljenja za proizvod v skladu s členom 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) ali 44(5).“;
Article 66(4) is replaced by the following:
člen 66(4) se nadomesti z naslednjim:
Any person submitting information related to an active substance or a biocidal product to the Agency or a competent authority for the purposes of this Regulation may request that the information in Article 67(3) and (4) not be made available, including a justification as to why the disclosure of the information could be harmful for that person’s commercial interests or those of any other party concerned.’;
Vsakdo, ki Agenciji ali pristojnemu organu za namene te uredbe predloži informacije v zvezi z aktivno snovjo ali biocidnim proizvodom, lahko zahteva, da se informacije iz člena 67(3) in (4) ne dajo na voljo, vključno z utemeljitvijo razlogov, zaradi katerih bi lahko bilo razkritje informacij škodljivo za poslovne interese te osebe ali interese druge zadevne strani.“;
in paragraph 1, the introductory part is replaced by the following:
v odstavku 1 se uvodni del nadomesti z naslednjim:
From the date on which the Commission adopts an implementing Regulation providing that an active substance is approved, as referred to in point (a) of Article 9(1), the following up-to-date information held by the Agency or the Commission on that active substance shall be made publicly and easily available free of charge:’;
Od dneva, ko Komisija sprejme izvedbeno uredbo o odobritvi aktivne snovi, kot je navedeno v točki (a) člena 9(1), se javnosti omogoči lahko dosegljiv in brezplačen dostop do naslednjih posodobljenih informacij o tej aktivni snovi, ki jih ima Agencija ali Komisija:“;
From the date on which the Commission adopts an implementing Regulation providing that an active substance is approved, as referred to in point (a) of Article 9(1), the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or the Agency as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to-date information on that active substance:’;
Od dneva, ko Komisija sprejme izvedbeno uredbo iz točke (a) člena 9(1) o odobritvi aktivne snovi, Agencija javnosti omogoči brezplačen dostop do naslednjih posodobljenih informacij o tej aktivni snovi, razen če pošiljatelj podatkov predloži utemeljitev v skladu s členom 66(4), ki jo pristojni organ ali Agencija sprejme kot veljavno, zakaj bi objava lahko škodovala njegovim poslovnim interesom ali interesom druge zadevne strani:“;
in Article 76(1), the following point is added:
v členu 76(1) se doda naslednja točka:
providing support and assistance to Member States with regard to control and enforcement activities.’;
zagotavljanje podpore in pomoči državam članicam pri nadzoru in izvrševanju.“;
in Article 77(1), the first subparagraph is replaced by the following:
v členu 77(1) se prvi pododstavek nadomesti z naslednjim:
Appeals against decisions of the Agency taken pursuant to Articles 7(2), 13(3), 43(2) and 45(3), Article 54(3), (4) and (5), and Articles 63(3) and 64(1) shall lie with the Board of Appeal set up in accordance with Regulation (EC) No 1907/2006.’;
Pritožbe proti sklepom Agencije, sprejetim v skladu s členi 7(2), 13(3), 43(2) in 45(3), členom 54(3), (4), in (5) ter členoma 63(3) in 64(1), se vložijo pri Odboru za pritožbe, ustanovljenem v skladu z Uredbo (ES) št. 1907/2006.“;
in Article 78(2), the second subparagraph is replaced by the following:
drugi pododstavek člena 78(2) se nadomesti z naslednjim:
‘Revenues of the Agency as referred to in Article 96(1) of Regulation (EC) No 1907/2006 shall not be used for carrying out tasks under this Regulation, unless for a joint purpose or a temporary transfer to ensure the proper functioning of the Agency. Revenues of the Agency as referred to in paragraph 1 of this Article shall not be used for carrying out tasks under Regulation (EC) No 1907/2006, unless for a joint purpose or a temporary transfer to ensure the proper functioning of the Agency.’;
„Prihodki Agencije iz člena 96(1) Uredbe (ES) št. 1907/2006 se ne uporabljajo za opravljanje nalog na podlagi te uredbe, razen če gre za skupen namen ali začasni prenos, da se zagotovi ustrezno delovanje Agencije. Prihodki Agencije iz odstavka 1 tega člena se ne uporabljajo za opravljanje nalog na podlagi Uredbe (ES) št. 1907/2006, razen za skupen namen ali začasni prenos, da se zagotovi ustrezno delovanje Agencije.“;
Article 86 is replaced by the following:
člen 86 se nadomesti z naslednjim:
‘Article 86
„Člen 86
Active substances for which the Commission has adopted directives including them in Annex I to Directive 98/8/EC shall be deemed to have been approved under this Regulation on the date of inclusion and shall be included in the list referred to in Article 9(2).
Za aktivne snovi, za katere je Komisija sprejela direktive in jih vključila v Prilogo I k Direktivi 98/8/ES, se šteje, da so bile odobrene v skladu s to uredbo na dan vključitve, in se vključijo na seznam iz člena 9(2).
Approval shall be subject to the conditions set out in those Commission directives.’;
Za odobritev veljajo pogoji iz navedenih direktiv Komisije.“;
By way of derogation from Articles 17(1), 19(1) and 20(1) of this Regulation, and without prejudice to paragraphs 1 and 3 of this Article, a Member State may continue to apply its current system or practice of making available on the market or using a given biocidal product for up to three years after the date of approval of the last of the active substances to be approved in that biocidal product.
Z odstopanjem od členov 17(1), 19(1) in 20(1) te uredbe in brez poseganja v odstavka 1 in 3 tega člena lahko država članica še naprej uporablja svoj obstoječ sistem ali prakso dostopnosti zadevnega biocidnega proizvoda na trgu ali njegove uporabe, in sicer do tri leta po datumu odobritve zadnjih aktivnih snovi tega biocidnega proizvoda, ki jih je treba odobriti.
The Member State concerned may, in accordance with its national rules, authorise the making available on the market or use in its territory only of a biocidal product containing only:
V skladu s svojimi nacionalnimi predpisi lahko zadevna država članica dovoli, da je na njenem ozemlju na trgu dostopen ali se uporablja samo biocidni proizvod, ki vsebuje le:
existing active substances which:
obstoječe aktivne snovi, ki:
have been evaluated under Commission Regulation (EC) No 1451/2007, but which have not yet been approved for that product-type; or
so bile ocenjene na podlagi Uredbe Komisije (ES) št. 1451/2007, vendar še niso odobrene za navedeno vrsto proizvoda, ali
are being evaluated, under Regulation (EC) No 1451/2007, but which have not yet been approved for that product-type;
se ocenjujejo na podlagi Uredbe (ES) št. 1451/2007, vendar še niso odobrene za navedeno vrsto proizvoda;
a combination of active substances referred to in point (a) and active substances approved in accordance with this Regulation.
kombinacijo aktivnih snovi iz točke (a) in aktivnih snovi, ki so bile odobrene v skladu s to uredbo.
By way of derogation from the first subparagraph, in the case of a decision not to approve an active substance, a Member State may continue to apply its current system or practice of making biocidal products available on the market for up to 12 months after the date of the decision not to approve an active substance in accordance with the third subparagraph of paragraph 1, and may continue to apply its current system or practice of using biocidal products for up to 18 months after that decision.
Z odstopanjem od prvega pododstavka lahko država članica v primeru odločitve, da se aktivna snov ne odobri, še naprej uporablja svoj obstoječi sistem ali prakso dostopnosti biocidnih proizvodov na trgu, in sicer do 12 mesecev po datumu odločitve, da se aktivna snov ne odobri, v skladu s tretjim pododstavkom odstavka 1, in lahko še naprej uporablja svoj obstoječi sistem ali prakso uporabe biocidnih proizvodov do 18 mesecev po tej odločitvi.
Following a decision to approve a particular active substance for a specific product-type, Member States shall ensure that authorisations for biocidal products of that product-type and containing that active substance are granted, modified or cancelled, as appropriate, in accordance with this Regulation within three years of the date of approval.
Po odločitvi za odobritev določene aktivne snovi za določeno vrsto proizvoda države članice zagotovijo, da se dovoljenja za biocidne proizvode te vrste, ki vsebujejo navedeno aktivno snov, izdajo, spremenijo ali prekličejo, kar je ustrezno, v skladu s to uredbo v treh letih po datumu odobritve.
To that effect, those wishing to apply for the authorisation or mutual recognition in parallel of biocidal products of that product-type containing no active substances other than existing active substances shall submit applications for authorisation or mutual recognition in parallel no later than the date of approval of the active substance(s).
V ta namen vlagatelji, ki želijo zaprositi za dovoljenje ali vzporedno medsebojno priznanje biocidnih proizvodov te vrste, ki razen obstoječih aktivnih snovi ne vsebujejo drugih aktivnih snovi, vložijo vlogo za izdajo dovoljenja ali vzporedno medsebojno priznanje najpozneje na dan odobritve aktivne snovi oziroma aktivnih snovi.
In the case of biocidal products containing more than one active substance, applications shall be submitted no later than the date of approval of the last active substance for that product-type.
V primeru, da biocidni proizvodi vsebujejo več kot eno aktivno snov, se vloge vložijo najpozneje na dan odobritve zadnje aktivne snovi za to vrsto proizvoda.
Where no application for authorisation or mutual recognition in parallel has been submitted in accordance with the second subparagraph:
Kadar vloga za izdajo dovoljenja ali vzporedno medsebojno priznanje ni bila vložena v skladu z drugim pododstavkom:
the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of the active substance(s); and
biocidni proizvod 180 dni po datumu odobritve aktivne oziroma aktivnih snovi ne sme biti več dostopen na trgu, in
use of existing stocks of the biocidal product may continue for up to 365 days after the date of approval of the active substance(s).’;
uporaba obstoječih zalog biocidnega proizvoda je še naprej dovoljena največ 365 dni po datumu odobritve aktivne oziroma aktivnih snovi.“;
Where a Member State’s competent authority, or where relevant, the Commission, decides to reject an application submitted in accordance with paragraph 3 for authorisation of a biocidal product already made available on the market, or decides not to grant an authorisation or to impose conditions for the authorisation making it necessary to change such a product, the following shall apply:
Kadar se pristojni organ države članice ali po potrebi Komisija odloči, da zavrne vlogo, vloženo v skladu z odstavkom 3, za izdajo dovoljenja za biocidni proizvod, ki je že dostopen na trgu, ali se odloči, da ne izda dovoljenja ali da uvede pogoje za izdajo dovoljenja, zaradi katerih je treba proizvod spremeniti, velja naslednje:
a biocidal product which has not been authorised or, where relevant, which does not comply with the conditions of the authorisation, shall no longer be made available on the market with effect from 180 days after the date of the decision of the authority; and
biocidni proizvod, za katerega dovoljenje ni bilo izdano ali ki ne izpolnjuje pogojev za izdajo dovoljenja, kadar je to potrebno, 180 dni po datumu odločitve organa ni več dostopen na trgu, in
use of existing stocks of the biocidal product may continue for up to 365 days after the date of the decision of the authority.’;
uporaba obstoječih zalog biocidnega proizvoda je še naprej dovoljena do največ 365 dni po datumu odločitve organa.“;
in Article 92(2), the following sentence is added:
v členu 92(2) se doda naslednji stavek:
‘Biocidal products authorised in accordance with Article 3 or 4 of Directive 98/8/EC shall be considered as authorised in accordance with Article 17 of this Regulation.’;
„Za biocidne proizvode, za katere je bilo dovoljenje izdano v skladu s členom 3 ali 4 Direktive 98/8/ES, velja, da je bilo dovoljenje zanje izdano v skladu s členom 17 te uredbe.“;
Article 93 is replaced by the following:
člen 93 se nadomesti z naslednjim:
By way of derogation from Article 17(1), a Member State may continue to apply its current system or practice of making available on the market and using a biocidal product not covered by the scope of Directive 98/8/EC, but falling within the scope of this Regulation, and consisting of, containing or generating only active substances that were available on the market, or used in biocidal products, on 1 September 2013.
Z odstopanjem od člena 17(1) lahko država članica še naprej uporablja svoj obstoječi sistem ali prakso dostopnosti na trgu in uporabe biocidnih proizvodov, ki niso zajeti v področju uporabe Direktive 98/8/ES, temveč spadajo v področje uporabe te uredbe, in so sestavljeni samo iz aktivnih snovi, ki so bile dostopne na trgu ali so se uporabljale v biocidnih proizvodih 1. septembra 2013, vsebujejo te snovi ali se uporabljajo za njihovo pridobivanje.
The derogation shall apply until one of the following dates:
Odstopanje velja do enega od naslednjih datumov:
where applications for approval of all those active substances, which the biocidal product consists of, contains or generates, are submitted for the relevant product-type by 1 September 2016, the deadlines provided for in the second subparagraph of Article 89(2), in Article 89(3) and in Article 89(4); or
kadar so vloge za odobritev vseh teh aktivnih snovi, iz katerih je biocidni proizvod sestavljen, jih vsebuje ali se uporablja za njihovo pridobivanje, za zadevne vrste proizvoda vložene do 1. septembra 2016, do rokov iz drugega pododstavka člena 89(2), v členu 89(3) in v členu 89(4), ali
where an application is not submitted in accordance with point (a) for one of the active substances, until 1 September 2017.’;
kadar vloga za katero od aktivnih snovi ni predložena v skladu s točko (a), do 1. septembra 2017.“;
Articles 94 and 95 are replaced by the following:
člena 94 in 95 se nadomestita z naslednjim: