natgillin/translations-raw huggingface dataset:
The structure and amount of the fees payable to the European Chemicals Agency, (hereinafter referred to as ‘the Agency’), as well as the conditions for payment should be established.
Treba je določiti strukturo in znesek pristojbin, ki se plačujejo Evropski agenciji za kemikalije (v nadaljnjem besedilu: Agencija), in pogoje za plačilo.
The structure and amount of the fees should take account of the work required by Regulation (EU) No 528/2012 to be carried out by the Agency.
Pri strukturi in zneskih pristojbin je treba upoštevati delo, ki ga mora Agencija opraviti v skladu z Uredbo (EU) št. 528/2012.
Fees should be set at such a level as to ensure that the revenue derived from them, when combined with other sources of the Agency’s revenue, is sufficient to cover the cost of the services delivered.
Pristojbine bi bilo treba določiti na stopnji, ki bo zagotavljala, da bo prihodek iz pristojbin skupaj z drugimi viri prihodkov Agencije zadosten za kritje stroškov opravljenih storitev.
It follows from Article 80(3)(d) of Regulation (EU) No 528/2012 that the structure and amount of fees is to take into account whether information has been submitted jointly or separately.
Iz člena 80(3)(d) Uredbe (EU) št. 528/2012 izhaja, da je pri strukturi in znesku pristojbin treba upoštevati, ali so bile informacije predložene skupaj ali ločeno.
In order to reflect the actual work load of the Agency and to promote joint submission of information, it is appropriate to only levy one fee per application, in case several persons apply jointly for the approval of an active substance or the renewal of an approval of an active substance.
Da bi pokazali dejansko delovno obremenitev Agencije in spodbujali skupno predložitev podatkov, je primerno, da se zaračuna samo ena pristojbina na vlogo, kadar več oseb skupaj zaprosi za odobritev aktivne snovi ali za podaljšanje odobritve aktivne snovi.
To take into account the specific needs of small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium sized enterprises [2] (hereinafter ‘SMEs’) established in the Union, reduced fees for active substance approval, renewal of approval or inclusion in Annex I to Regulation (EU) No 528/2012 and biocidal product authorisation or renewal should apply to such companies.
Da bi upoštevali posebne potrebe malih in srednje velikih podjetij v smislu Priporočila Komisije 2003/361/ES z dne 6. maja 2003 o opredelitvi mikro, malih in srednje velikih podjetij [2] (v nadaljnjem besedilu: MSP) s sedežem v Uniji, bi se za takšna podjetja morale uporabljati znižane pristojbine za odobritev aktivnih snovi, podaljšanje odobritve ali vključitev v Prilogo I k Uredbi (EU) št. 528/2012 in za izdajanje dovoljenj za biocidne proizvode ali njihovo podaljšanje.
The levels of the reductions should take into account the significant proportion of SMEs in the biocides sector combined with the interest of avoiding excessive fees for other enterprises while ensuring that the Agency’s work is fully financed.
Stopnje znižanja bi morale upoštevati pomemben delež MSP v sektorju biocidov kot tudi interes, da bi se izognili pretiranim pristojbinam za druga podjetja, obenem pa bi morale zagotoviti, da bo delo Agencije v celoti financirano.
For the purpose of discouraging applications for products containing active substances fulfilling one of the substitution criteria listed in Article 10(1) of Regulation (EU) No 528/2012, as well as of such active substances, reductions should not apply to applications for such biocidal products or active substances.
Da bi odvrnili od vlaganja vlog za proizvode, ki vsebujejo aktivne snovi, ki izpolnjujejo eno od meril za zamenjavo, navedenih v členu 10(1) Uredbe (EU) št. 528/2012, in za takšne aktivne snovi, znižanja ne bi smela veljati za vloge za takšne biocidne proizvode ali aktivne snovi.
Taking into account the Agency’s work required to handle an appeal lodged in accordance with Article 77 of Regulation (EU) No 528/2012, it is appropriate to levy a fee for such appeals in accordance with the third subparagraph of Article 77(1) of that Regulation.
Ob upoštevanju dela, ki ga mora Agencija opraviti za obravnavo pritožbe, vložene v skladu s členom 77 Uredbe (EU) št. 528/2012, je primerno, da se za takšne pritožbe zaračuna pristojbine v skladu s tretjim pododstavkom člena 77(1) navedene uredbe.
However, to avoid penalising persons launching justified appeals, it is appropriate to refund such fees where the appeal is well founded.
Da pa bi se izognili kaznovanju oseb, ki vložijo utemeljene pritožbe, je primerno, da se take pristojbine vrnejo, če je pritožba utemeljena.
Taking into account the reduced work required by the Agency in cases where applications are rejected before or during validation, or withdrawn during their assessment, it is appropriate to provide for partial refund of fees in such cases.
Ob upoštevanju zmanjšane količine dela, ki ga mora Agencija opraviti v primerih, ko so vloge zavrnjene pred ali med validacijo ali umaknjene med ocenjevanjem, je primerno, da se v takih primerih omogoči delno vračilo pristojbin.
For the purpose of encouraging applications for approval of active substances that are suitable alternatives to approved active substances fulfilling one of the exclusion criteria listed in Article 5(1) of Regulation (EU) No 528/2012, it is appropriate to provide for reimbursement of the fee for such applications.
Da bi spodbudili vlaganje vlog za odobritev aktivnih snovi, ki so primerna nadomestila za odobrene aktivne snovi, ki izpolnjujejo eno od meril za izključitev, navedenih v členu 5(1) Uredbe (EU) št. 528/2012, je primerno, da se za take zahtevke zagotovi nadomestilo za pristojbino.
The fee for applications for inclusion in Annex I to Regulation (EU) No 528/2012 of active substances that do not give rise to concern should take into account the estimated work required by the Agency to handle such applications, as well as the public interest in allowing products containing such substances to be authorised.
Pri pristojbinah za vloge za vključitev aktivnih snovi, ki ne vzbujajo zaskrbljenosti, v Prilogo I k Uredbi (EU) št. 528/2012 je treba upoštevati ocenjeno delo, ki ga mora opraviti Agencija za obravnavo takšnih vlog, kot tudi javni interes, da se omogoči odobritev proizvodov, ki vsebujejo take snovi.
For the purpose of discouraging applications for approval or renewal of approval of active substances fulfilling one of the substitution criteria listed in Article 10(1) of Regulation (EU) No 528/2012 as well as applications for authorisation or renewal of products requiring a comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012, and of contributing to financing the waivers and reductions provided for by this Regulation, it is appropriate to provide for increased fees for such applications.
Da bi odvrnili od vlaganja vlog za odobritev ali podaljšanje odobritve aktivnih snovi, ki izpolnjujejo eno od meril za zamenjavo, navedenih v členu 10(1) Uredbe (EU) št. 528/2012, in vlog za odobritev ali podaljšanje proizvodov, za katere je potrebna primerjalna ocena v skladu s členom 23 Uredbe (EU) št. 528/2012, in da bi prispevali k financiranju oprostitev in znižanj iz te uredbe, je primerno, da se za takšne vloge omogoči višje pristojbine.
In view of the Agency’s work required to handle a request for an opinion on the classification of a change in accordance with Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council [3], it is appropriate to levy a fee for such requests.
Glede na potrebno delo Agencije za obravnavo zahtev za mnenje o razvrščanju sprememb v skladu z Izvedbeno uredbo Komisije (EU) št. 354/2013 z dne 18. aprila 2013 o spremembah biocidnih proizvodov, za katere je bilo izdano dovoljenje v skladu z Uredbo (EU) št. 528/2012 Evropskega parlamenta in Sveta [3], je primerno, da se za take zahteve zaračuna pristojbina.
However, to avoid, to the extent possible, penalising applicants whose requests to have a change classified as minor or administrative are justified, it is appropriate to grant a fee reduction to the subsequent application for a change, where the request leads to a recommendation to classify the change as an administrative or minor change.
Da pa bi se v največji možni meri izognili kaznovanju vlagateljev upravičenih zahtev po razvrstitvi sprememb kot manjše ali upravne, je primerno odobriti znižanje pristojbine za vlogo za spremembo, ki temu sledi, če vloga vodi k priporočilu za razvrstitev spremembe kot upravne ali manjše spremembe.
Given the Agency’s work required to treat submissions for inclusion in the list of relevant persons referred to in Article 95 of Regulation (EU) No 528/2012, it is appropriate to levy a fee for such submissions.
Glede na delo Agencije, potrebno za obravnavo vlog za vključitev na seznam zadevnih oseb iz člena 95 Uredbe (EU) št. 528/2012, je primerno, da se za takšne vloge zaračuna pristojbina.
The amount of work required for such submission will vary significantly depending on whether the relevant person submits a letter of access or a new dossier, since, in the latter case, the Agency will have to check that the dossier complies with Annex II to Regulation (EU) No 528/2012 or, where appropriate, Annex IIA to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing on the market of biocidal products [4].
Obseg dela, potrebnega za takšne vloge, se lahko znatno razlikuje glede na to, ali je zadevna oseba predložila izjavo o dostopnosti podatkov ali novo dokumentacijo, saj bo v slednjem primeru Agencija morala preveriti, ali je dokumentacija v skladu s Prilogo II k Uredbi (EU) št. 528/2012 oziroma, kjer je to primerno, s Prilogo IIA k Direktivi 98/8/ES Evropskega parlamenta in Sveta z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promet [4].
It is appropriate to differentiate the fee accordingly.
Primerno je, da se pristojbina ustrezno razlikuje.
Given the Agency’s work required to handle a request for confidentiality in accordance with Article 66(4) of Regulation (EU) No 528/2012, it is appropriate to levy a fee for such requests.
Glede na delo Agencije, potrebno za obravnavo zahtevkov po zaupnosti v skladu s členom 66(4) Uredbe (EU) št. 528/2012, je primerno, da se za take zahtevke zaračuna pristojbina.
Since the Agency’s budget is drawn up and implemented in euro, and its accounts are also presented in euro in accordance with Article 19 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 [5], with Article 17 of Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities [6] and with Article 17 of the Financial Regulation of the European Chemicals Agency of 24 September 2008 [7], it is appropriate to levy fees only in euro.
Ker se proračun Agencije pripravi in izvršuje v eurih in ker so v eurih predstavljeni tudi njeni računovodski izkazi v skladu s členom 19 Uredbe (EU, Euratom) št. 966/2012 Evropskega parlamenta in Sveta z dne 25. oktobra 2012 o finančnih pravilih, ki se uporabljajo za splošni proračun Unije, in razveljavitvi Uredbe Sveta (ES, Euratom) št. 1605/2002 [5], s členom 17 Uredbe Komisije (ES, Euratom) št. 2343/2002 z dne 23. decembra 2002 o okvirni finančni uredbi za organe iz člena 185 Uredbe Sveta (ES, Euratom) št. 1605/2002 o finančni uredbi za splošni proračun Evropskih skupnosti [6] in s členom 17 finančne uredbe Evropske agencije za kemikalije z dne 24. septembra 2008 [7], je primerno, da se pristojbine zaračunavajo izključno v eurih.
It follows from Article 80(3)(f) of Regulation (EU) No 528/2012 that the deadlines for the payment of fees should be fixed taking due account of the deadlines of the procedures provided for in that Regulation.
Iz člena 80(3)(f) Uredbe (EU) št. 528/2012 izhaja, da bi bilo treba roke za plačilo pristojbin določiti ob upoštevanju rokov postopkov iz navedene uredbe.
The fees set out in this Regulation should be reviewed at appropriate intervals, with a view to aligning the fees with the inflation rate and with the actual costs to the Agency of the services provided.
Pristojbine, določene v tej uredbi, bi bilo treba preverjati v ustreznih časovnih razmakih, da bi se pristojbine usklajevale s stopnjo inflacije in z dejanskimi stroški storitev, ki jih zagotavlja Agencija.
These reviews should take into account the Agency’s increased experience in dealing with applications under the Regulation and the efficiencies thereby gained.
Ti pregledi bi morali upoštevati pridobivanje izkušenj Agencije pri obravnavanju vlog v skladu s to uredbo in posledično povečano učinkovitost.
The Standing Committee on Biocidal Products referred to in Article 82(1) of Regulation (EU) No 528/2012 did not deliver an opinion on the measures provided for in this Regulation.
Stalni odbor za biocidne pripravke iz člena 82(1) Uredbe (EU) št. 528/2012 ni sprejel mnenja o ukrepih iz te uredbe.
Since an implementing act was deemed to be necessary, the chair submitted the draft implementing act to the appeal committee for further deliberation.
Ker je bil izvedbeni akt potreben, je predsednik predložil osnutek izvedbenega akta odboru za pritožbe v nadaljnjo razpravo.
Fees for work in relation to active substances
Pristojbine za delo v zvezi z aktivnimi snovmi
The Agency shall levy the fees provided for in Table 1 of Annex I for work required by Regulation (EU) No 528/2012 to be carried out in relation to approval and renewal of approval of active substances, as well as inclusion in Annex I to that Regulation.
Agencija zaračuna pristojbine, določene v razpredelnici 1 Priloge I, za delo, ki ga mora opraviti v skladu z Uredbo (EU) št. 528/2012 v zvezi odobritvijo in podaljšanjem odobritve aktivnih snovi ter njihovo vključitvijo v Prilogo I k navedeni uredbi.
Fees for work in relation to Union authorisation of biocidal products
Pristojbine za delo v zvezi z dovoljenjem Unije za biocidne proizvode
The Agency shall levy the fees provided for in Table 1 of Annex II for work required by Regulation (EU) No 528/2012 to be carried out in relation to Union authorisation of biocidal products.
Agencija zaračuna pristojbine, določene v razpredelnici 1 Priloge II, za delo, ki ga mora opraviti v skladu z Uredbo (EU) št. 528/2012 v zvezi z dovoljenjem Unije za biocidne proizvode.
Other fees
Druge pristojbine
The Agency shall levy the fees provided for in Annex III for work required by Regulation (EU) No 528/2012 to be carried out in relation to establishment of technical equivalence, applications for mutual recognition, requests for inclusion in the list of relevant persons, and requests for confidential treatment of information submitted to the Agency.
Agencija zaračuna pristojbine, določene v Prilogi III, za delo, ki ga mora opraviti v skladu z Uredbo (EU) št. 528/2012 v zvezi z določitvijo tehnične enakovrednosti, vlogami za medsebojno priznavanje, zahtevki za vključitev na seznam zadevnih oseb in zahtevki za zaupno obravnavo informacij, predloženimi Agenciji.
The Agency shall levy the annual fees provided for in Annex III for every biocidal product or biocidal product family authorised by the Union.
Agencija zaračuna letne pristojbine iz Priloge III za vsak biocidni proizvod ali družino biocidnih proizvodov, za katere Unija izda dovoljenje.
The annual fee shall be due on the first and each subsequent anniversary of the entry into force of the authorisation.
Letna pristojbina zapade na prvo in vsako naslednjo obletnico začetka veljavnosti dovoljenja.
It shall relate to the preceding year.
Nanaša se na preteklo leto.
Fees for appeals against a decision of the Agency under Article 77 of Regulation (EU) No 528/2012
Pristojbine za pritožbe zoper sklep Agencije v skladu s členom 77 Uredbe (EU) št. 528/2012
For any appeal against a decision of the Agency under Article 77 of Regulation (EU) No 528/2012, the Agency shall levy a fee as set out in Annex III.
Za vse pritožbe zoper sklep Agencije v skladu s členom 77 Uredbe (EU) št. 528/2012 Agencija zaračuna pristojbino, kot je določeno v Prilogi III.
An appeal shall not be considered to be received by the Board of Appeal until the relevant fee has been received by the Agency.
Dokler Agencija ne prejme ustrezne pristojbine, se šteje, da Odbor za pritožbe ni prejel pritožbe.
If the appeal is considered inadmissible by the Board of Appeal, the fee shall not be refunded.
Če Odbor za pritožbe meni, da je pritožba nesprejemljiva, se pristojbina ne vrne.
The Agency shall refund the fee levied in accordance with paragraph 1 if the Executive Director of the Agency rectifies a decision in accordance with Article 93(1) of Regulation (EU) No 1907/2006 of the European Parliament and of the Council [8], or if the appeal is decided in favour of the appellant.
Agencija vrne pristojbino, zaračunano v skladu z odstavkom 1, če izvršni direktor Agencije sklep popravi v skladu s členom 93(1) Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta [8] ali če je pritožba rešena v dobro pritožnika.
Reimbursement possibility for alternatives to approved active substances fulfilling one of the exclusion criteria
Možnost povračila stroškov za nadomestila za odobrene aktivne snovi, ki izpolnjujejo eno od meril za izključitev
Upon submission of an application to the Agency for the approval of an active substance, which may be a suitable alternative, within the meaning of the second subparagraph of Article 5(2) of Regulation (EU) No 528/2012, to an approved active substance fulfilling one of the exclusion criteria pursuant to Article 5(1) of that Regulation, an applicant may request reimbursement of the fee to be paid to the Agency.
Ob predložitvi vloge Agenciji za odobritev aktivne snovi, ki je v smislu drugega pododstavka člena 5(2) Uredbe (EU) št. 528/2012 lahko primerno nadomestilo za odobreno aktivno snov, ki izpolnjuje eno od meril za izključitev v skladu s členom 5(1) navedene uredbe, lahko vlagatelj zahteva povračilo pristojbine, ki jo je treba plačati Agenciji.
Upon receipt of the opinion from the Agency in accordance with Article 8(4) of Regulation (EU) No 528/2012, which shall also include a recommendation on whether the active substance is a suitable alternative within the meaning of the second subparagraph of Article 5(2) of Regulation (EU) No 528/2012, the Commission shall decide on the request.
Po prejemu mnenja Agencije v skladu s členom 8(4) Uredbe (EU) št. 528/2012, ki vsebuje tudi priporočilo o tem, ali je aktivna snov primerno nadomestilo v smislu drugega pododstavka člena 5(2) Uredbe (EU) št. 528/2012, Komisija odloči o zahtevku.
Where the Commission decides that the active substance is a suitable alternative, the Agency shall inform the applicant thereof and fully reimburse the fee referred to in paragraph 1.
Kadar Komisija odloči, da je aktivna snov primerno nadomestilo, Agencija o tem obvesti vlagatelja in mu v celoti vrne pristojbino iz odstavka 1.
SUPPORT FOR SMEs
PODPORA ZA MSP
Recognition of SME status
Priznavanje statusa MSP
Before submission of an application to the Agency for approval, renewal or inclusion in Annex I to Regulation (EU) No 528/2012 of an active substance or for Union authorisation of a biocidal product or biocidal product family, submitted in accordance with Articles 7(1), 13(1), 28(4), 43(1) or 45(1) of that Regulation respectively, containing a claim for SME reduction, the prospective applicant shall submit to the Agency the relevant elements proving entitlement to such reduction by virtue of the status of SME in the meaning of Recommendation 2003/361/EC.
Pred predložitvijo vloge Agenciji za odobritev, podaljšanje ali vključitev aktivne snovi v Prilogo I k Uredbi (EU) št. 528/2012 ali za dovoljenje Unije za biocidni proizvod ali družino biocidnih proizvodov, predložene v skladu s členom 7(1), členom 13(1), členom 28(4), členom 43(1) oziroma členom 45(1) navedene uredbe, ki vsebuje zahtevek za znižanje za MSP, morebitni vlagatelj Agenciji predloži ustrezne elemente, ki dokazujejo upravičenost do takšnega znižanja na podlagi statusa MSP v smislu Priporočila 2003/361/ES.
In the case of an application for approval, renewal or inclusion of an active substance in Annex I to Regulation (EU) No 528/2012, the question shall be determined by reference to the active substance manufacturer that is represented by the prospective applicant.
V primeru vloge za odobritev, podaljšanje ali vključitev aktivne snovi v Prilogo I k Uredbi (EU) št. 528/2012 se o tem odloči glede na proizvajalca aktivne snovi, ki ga predstavlja morebitni vlagatelj.
In case of an application for product authorisation or renewal of product authorisation, the question shall be determined by reference to the prospective authorisation holder.
V primeru vloge za izdajo dovoljenja ali podaljšanje dovoljenja za proizvod se o tem odloči glede na morebitnega imetnika dovoljenja.
The Agency shall publish a list of the relevant elements to be submitted in accordance with paragraph 1.
Agencija objavi seznam ustreznih elementov, ki jih je treba predložiti v skladu z odstavkom 1.
Within 45 days of receipt of all the relevant elements referred to in paragraph 1, the Agency shall decide what SME status, if any, can be recognised.
V roku 45 dni od prejema vseh ustreznih elementov iz odstavka 1 Agencija odloči, kateri status MSP, če sploh, se lahko prizna.
A recognition of an enterprise as an SME shall be valid for applications submitted under Regulation (EU) No 528/2012 for two years.
Priznanje statusa MSP za vloge, predložene v skladu z Uredbo (EU) št. 528/2012, velja dve leti.
An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against a decision taken by the Agency under paragraph 4.
V skladu s členom 77 Uredbe (EU) št. 528/2012 se zoper odločitev Agencije lahko vloži pritožba v skladu z odstavkom 4.
Fee Reductions
Znižanje pristojbin
Reductions of fees payable to the Agency as set out in Table 2 of Annex I and Table 2 of Annex II shall be granted to SMEs established in the Union.
Znižanje pristojbin, ki se plačajo Agenciji, kot je določeno v razpredelnici 2 Priloge I in razpredelnici 2 Priloge II, se odobri za MSP s sedežem v Uniji.
Reductions for applications for active substance approval, renewal of approval or inclusion in Annex I to Regulation (EU) No 528/2012 shall only be granted when the active substance is not a candidate for substitution.
Znižanja pri vlogah za odobritev, podaljšanje odobritve ali vključitev aktivnih snovi v Prilogo I k Uredbi (EU) št. 528/2012 se odobri le, kadar aktivna snov ni možna snov za zamenjavo.
Reductions for applications for biocidal product authorisation or renewal of authorisation shall only be granted when the product does not contain an active substance which is a candidate for substitution.
Znižanja pri vlogah za izdajo dovoljenja za biocidne proizvode ali podaljšanje dovoljenja se odobri le, kadar proizvod ne vsebuje aktivne snovi, ki je možna snov za zamenjavo.
The fees provided for by this Regulation shall be paid in euro.
Pristojbine, določene s to uredbo, se plačajo v eurih.
Payments shall be made only after the Agency has issued an invoice.
Plačilo se izvede šele po tem, ko Agencija izda račun.
By derogation from paragraph 2, payments due under Article 4 shall be made at the time of the submission of the appeal.
Z odstopanjem od odstavka 2 se zapadla plačila v skladu s členom 4 izvedejo ob vložitvi pritožbe.
Every payment, with the exception of payments referred to in Article 8(3), shall indicate in the reference field the invoice number.
Za vsako plačilo, z izjemo plačil iz člena 8(3), je treba v polju za sklic navesti številko računa.