natgillin/translations-raw huggingface dataset:
In the event that the Register for Biocidal Products is not fully operational by 1 September 2013 or ceases to be operational after that date, all obligations in relation to submissions and communication placed upon Member States, competent authorities, the Commission and applicants by this Regulation shall continue to apply.
Če register biocidnih proizvodov do 1. septembra 2013 ne bo popolnoma deloval ali bo po tem datumu prenehal delovati, za države članice, pristojne organe, Komisijo in vlagatelje še naprej veljajo vse obveznosti v zvezi z vlogami in obveščanjem iz te uredbe.
With a view to ensuring the uniform application of this paragraph, particularly with regard to the format in which information may be submitted and exchanged, the Commission shall adopt the necessary measures in accordance with the examination procedure referred to in Article 82(3).
Da bi bila zagotovljena enotna uporaba tega odstavka, zlasti glede formata, v katerem se predložijo ali izmenjajo informacije, Komisija sprejme potrebne ukrepe v skladu s postopkom pregleda iz člena 82(3).
Those measures shall be limited in time to the period strictly necessary for the Register for Biocidal Products to become fully operational.
Ti ukrepi so časovno omejeni na obdobje, ki je nujno potrebno za popolno delovanje registra biocidnih proizvodov.
The Commission may adopt implementing acts laying down detailed rules on the types of information to be entered in the Register for Biocidal Products.
Komisija lahko sprejme izvedbene akte, ki določajo podrobna pravila o vrstah informacij, ki se vnesejo v register biocidnih proizvodov.
The Commission shall be empowered to adopt delegated acts in accordance with Article 83 laying down supplementary rules for the use of the Register.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 83, ki določajo dodatna pravila za uporabo registra.
Advertisers may replace the word ‘biocides’ in the prescribed sentences with a clear reference to the product-type being advertised.
Oglaševalci lahko v predpisanih stavkih besedo „biocidi“ nadomestijo z jasnim sklicevanjem na vrsto proizvoda, ki se oglašuje.
Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy.
Oglasi za biocidne proizvode ne predstavljajo proizvoda na način, ki je zavajajoč glede tveganja, ki ga proizvod predstavlja za zdravje človeka, zdravje živali ali okolje, ali njegove učinkovitosti.
In any case, the advertising of a biocidal product shall not mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or any similar indication.
V nobenem primeru oglasi za biocidni proizvod ne smejo vsebovati navedb „biocidni proizvod z manjšim tveganjem“, „nestrupen“, „neškodljiv“, „naraven“, „okolju prijazen“, „živalim prijazen“ ali katero drugo podobno oznako.
Poison control
Nadzor strupov
Article 45 of Regulation (EC) No 1272/2008 shall apply for the purposes of this Regulation.
Za namene te uredbe se uporablja člen 45 Uredbe (ES) št. 1272/2008.
THE AGENCY
AGENCIJA
Role of the Agency
Vloga Agencije
The Agency shall carry out the tasks conferred on it by this Regulation.
Agencija opravlja naloge, ki so ji dodeljene s to uredbo.
Articles 78 to 84, 89 and 90 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis taking into account the role of the Agency with respect to this Regulation.
Členi od 78 do 84, 89 in 90 Uredbe (ES) št. 1907/2006 se smiselno uporabljajo, pri čemer se upošteva vloga Agencije glede na to uredbo.
Biocidal Products Committee
Odbor za biocidne proizvode
A Biocidal Products Committee is hereby established within the Agency.
Znotraj Agencije se ustanovi Odbor za biocidne proizvode.
The Biocidal Products Committee shall be responsible for preparing the opinion of the Agency on the following issues:
Odbor za biocidne proizvode je odgovoren za pripravo mnenja Agencije o naslednjih vprašanjih:
applications for approval and renewal of approval of active substances;
vloge za odobritev ali podaljšanje odobritve aktivnih snovi;
review of approval of active substances;
pregled odobritve aktivnih snovi;
applications for inclusion in Annex I of active substances meeting the conditions laid down in Article 28 and review of the inclusion of such active substances in Annex I;
vloge za vključitev v Prilogo I aktivnih snovi, ki izpolnjujejo pogoje iz člena 28 in pregled vključitve takšnih aktivnih snovi v Prilogo I;
identification of active substances which are candidates for substitution;
določitev aktivnih snovi, ki so možne snovi za zamenjavo;
applications for Union authorisation of biocidal products and for renewal, cancellation and amendments of Union authorisations, except where the applications are for administrative changes;
vloge za dovoljenje Unije za biocidne proizvode ter za podaljšanje, preklic in spremembo dovoljenj Unije, razen v primeru vlog za upravne spremembe;
scientific and technical matters concerning mutual recognition in accordance with Article 38;
znanstvene in tehnične zadeve v zvezi z medsebojnim priznavanjem v skladu s členom 38;
at the request of the Commission or of Member States’ competent authorities, any other questions that arise from the operation of this Regulation relating to technical guidance or risks to human health, animal health or the environment.
na zahtevo Komisije ali pristojnih organov držav članic o vseh drugih vprašanjih, ki izhajajo iz izvajanja te uredbe, v zvezi s tehničnimi smernicami ali tveganji za zdravje človeka, zdravje živali ali okolje.
Each Member State shall be entitled to appoint a member of the Biocidal Products Committee.
Vsaka država članica je upravičena, da imenuje člana Odbora za biocidne proizvode.
Member States may also appoint an alternate member.
Države članice lahko imenujejo tudi njegovega namestnika.
In order to facilitate its work, the Committee may, by a decision of the Management Board of the Agency in agreement with the Commission, be divided into two or more parallel committees.
Zaradi lažjega opravljanja dela se lahko Odbor po odločitvi upravnega odbora Agencije in v dogovoru s Komisijo razdeli v dva ali več vzporednih odborov.
Each parallel committee shall be responsible for the tasks of the Biocidal Products Committee assigned to it.
Vsak vzporedni odbor je odgovoren za naloge Odbora za biocidne proizvode, ki so mu dodeljene.
Each Member State shall be entitled to appoint one Member for each of the parallel committees.
Vsaka država članica lahko imenuje po enega člana za vsak vzporedni odbor.
The same person may be appointed to more than one parallel committee.
Ista oseba je lahko imenovana v več vzporednih odborov.
Committee members shall be appointed on the basis of their experience relevant to performing the tasks specified in paragraph 1 and may work within a competent authority.
Člani odbora so imenovani na podlagi svojih izkušenj pri opravljanju nalog iz odstavka 1 in so lahko zaposleni pri pristojnem organu.
They shall be supported by the scientific and technical resources available to Member States.
V pomoč so jim znanstvena in tehnična sredstva, ki so na razpolago državam članicam.
To this end, Member States shall provide adequate scientific and technical resources to Committee members that they have nominated.
V ta namen države članice članom Odbora, ki so jih imenovale, zagotovijo ustrezna znanstvena in tehnična sredstva.
Article 85, paragraphs 4, 5, 8 and 9, and Articles 87 and 88 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis to the Biocidal Products Committee.
Za Odbor za biocidne proizvode se smiselno uporabljajo člen 85, odstavki 4, 5, 8 in 9, ter člena 87 in 88 Uredbe (ES) št. 1907/2006.
Secretariat of the Agency
Sekretariat Agencije
The Secretariat of the Agency referred to in point (g) of Article 76(1) of Regulation (EC) No 1907/2006 shall undertake the following tasks:
Sekretariat Agencije iz točke (g) člena 76(1) Uredbe (ES) št. 1907/2006 opravlja naslednje naloge:
establishing and maintaining the Register for Biocidal Products;
vzpostavitev in vzdrževanje registra biocidnih proizvodov;
performing the tasks relating to the acceptance of the applications covered by this Regulation;
opravljanje nalog v zvezi s sprejemanjem vlog, ki jih zajema ta uredba;
establishing technical equivalence;
ugotavljanje tehnične ekvivalence;
providing technical and scientific guidance and tools for the application of this Regulation by the Commission and Member States’ competent authorities and providing support to national helpdesks;
zagotavljanje tehničnih in znanstvenih smernic ter orodij za uporabo te uredbe s strani Komisije in pristojnih organov držav članic ter zagotavljanje podpore nacionalnim službam za pomoč uporabnikom;
providing advice and assistance to applicants, in particular to SMEs, for the approval of an active substance or its inclusion in Annex I to this Regulation or for a Union authorisation;
svetovanje in pomoč vlagateljem, zlasti MSP, ki zaprosijo za odobritev aktivne snovi ali njeno vključitev v Prilogo I te uredbe ali za dovoljenje Unije;
preparing explanatory information on this Regulation;
priprava pojasnil o tej uredbi;
establishing and maintaining database(s) with information on active substances and biocidal products;
vzpostavitev in vzdrževanje zbirk podatkov z informacijami o aktivnih snoveh in biocidnih proizvodih;
at the request of the Commission, providing technical and scientific support to improve cooperation between the Union competent authorities, international organisations and third countries on scientific and technical issues relating to biocidal products;
na zahtevo Komisije zagotavljanje tehnične in znanstvene podpore za izboljšanje sodelovanja med pristojnimi organi Unije, mednarodnimi organizacijami in tretjimi državami glede znanstvenih in tehničnih vprašanj v zvezi z biocidnimi proizvodi;
notification of decisions taken by the Agency;
uradno obveščanje o sklepih Agencije;
specification of formats and software packages for the submission of information to the Agency;
specifikacija formatov in paketov programske opreme za predložitev informacij Agenciji;
providing support and assistance to Member States in order to avoid the parallel assessment of applications relating to the same or similar biocidal products referred to in Article 29(4);
zagotavljanje podpore in pomoči državam članicam, da bi preprečili vzporedno oceno vlog v zvezi z enakimi ali podobnimi biocidnimi proizvodi iz člena 29(4).
The Secretariat shall make the information identified in Article 67 publicly available, free of charge, over the internet, except where a request made under Article 66(4) is considered justified.
Sekretariat da na voljo informacije iz člena 67 brezplačno javnosti prek interneta, razen kadar je zahtevek na podlagi člena 66(4) utemeljen.
The Agency shall make other information available on request in accordance with Article 66.
Agencija na zahtevo omogoči dostop do drugih informacij v skladu s členom 66.
Appeals against decisions of the Agency taken pursuant to Article 7(2), Article 13(3), Article 26(2), Article 43(2), Article 45(3), Article 54(3), (4) and (5), Article 63(3) and Article 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 členom 7(2), členom 13(3), členom 26(2), členom 43(2), členom 45(3), členom 54(3), (4) in (5), členom 63(3) in členom 64(1), se vložijo pri Odboru za pritožbe, ustanovljenem v skladu z Uredbo (ES) št. 1907/2006.
Article 92(1) and (2) and Articles 93 and 94 of Regulation (EC) No 1907/2006 shall apply to appeal procedures lodged under this Regulation.
Člen 92(1) in (2) ter člena 93 in 94 Uredbe (ES) št. 1907/2006 se uporabljajo za pritožbene postopke, vložene na podlagi te uredbe.
Fees may be payable, in accordance with Article 80(1) of this Regulation, by the person bringing an appeal.
Od osebe, ki vloži pritožbo, se lahko zahteva plačilo pristojbin v skladu s členom 80(1) te uredbe.
For the purposes of this Regulation, the revenues of the Agency shall consist of:
Za namene te uredbe prihodke Agencije sestavljajo:
a subsidy from the Union, entered in the general budget of the European Union (Commission Section);
subvencija Unije, vključena v splošni proračun Evropske unije (oddelek Komisija);
the fees paid to the Agency in accordance with this Regulation;
pristojbine, plačane Agenciji v skladu s to uredbo;
any charges paid to the Agency for services that it provides under this Regulation;
vse takse, plačane Agenciji za storitve, ki jih opravi na podlagi te uredbe;
any voluntary contributions from Member States.
vsi prostovoljni prispevki držav članic.
Revenue and expenditure for activities related to this Regulation and to Regulation (EC) No 1907/2006 shall be dealt with separately in the Agency’s budget and shall have separate budgetary and accounting reporting.
Prihodki in odhodki za dejavnosti, povezane s to uredbo in Uredbo (ES) št. 1907/2006, se v proračunu Agencije obravnavajo ločeno in zanje se sestavi ločeno proračunsko in računovodsko poročilo.
Revenue of the Agency referred to in Article 96(1) of Regulation (EC) No 1907/2006 shall not be used for carrying out tasks under this Regulation.
Prihodki Agencije iz člena 96(1) Uredbe (ES) št. 1907/2006 se ne uporabljajo za opravljanje nalog na podlagi te uredbe.
Revenue of the Agency referred to in paragraph 1 of this Article shall not be used for carrying out tasks under Regulation (EC) No 1907/2006.
Prihodki Agencije iz odstavka 1 tega člena se ne uporabljajo za opravljanje nalog na podlagi Uredbe (ES) št. 1907/2006.
Formats and software for submission of information to the Agency
Formati in programska oprema za predložitev informacij Agenciji
The Agency shall specify formats and software packages and make them available free of charge on its website for submissions to the Agency.
Agencija določi formate in programske pakete ter jih da na voljo brezplačno na svoji spletni strani.
The competent authorities and applicants shall use these formats and packages in their submissions pursuant to this Regulation.
Pristojni organi in vlagatelji uporabljajo te formate in pakete pri predložitvah v skladu s to uredbo.
The technical dossier referred to in Article 6(1) and Article 20 shall be submitted using the IUCLID software package.
Tehnična dokumentacija iz člena 6(1) in člena 20 se predloži z uporabo programske opreme IUCLID.
The Commission shall adopt, on the basis of the principles set out in paragraph 3, an implementing Regulation specifying:
Komisija na podlagi načel iz odstavka 3 sprejme izvedbeno uredbo, v kateri določi:
the fees payable to the Agency, including an annual fee for products granted a Union authorisation in accordance with Chapter VIII and a fee for applications for mutual recognition in accordance with Chapter VII;
pristojbine, ki se plačujejo Agenciji, vključno z letno pristojbino za proizvode, za katere je izdano dovoljenje Unije v skladu s poglavjem VIII, in pristojbino za vloge za medsebojno priznanje v skladu s poglavjem VII;
the rules defining conditions for reduced fees, fee waivers and the reimbursement of the member of the Biocidal Products Committee who acts as a rapporteur; and
pravila glede pogojev za nižje pristojbine, oprostitev pristojbin in povračilo za člana Odbora za biocidne proizvode, ki opravlja nalogo poročevalca, in
conditions of payment.
pogoje plačila.
It shall apply only with respect to fees paid to the Agency.
Uporablja se le v zvezi s pristojbinami, ki se plačujejo Agenciji.
The fees payable to the Agency shall be set at such a level as to ensure that the revenue derived from the fees, when combined with other sources of the Agency’s revenue pursuant to this Regulation, is sufficient to cover the cost of the services delivered.
Pristojbine, ki se plačujejo Agenciji, se določijo na taki ravni, da prihodki, ki izhajajo iz pristojbin, v kombinaciji z drugimi viri prihodkov Agencije na podlagi te uredbe zadostujejo za kritje stroškov opravljenih storitev.
The fees payable shall be published by the Agency.
Pristojbine, ki se plačujejo, objavi Agencija.
Member States shall directly charge applicants fees for services that they provide with respect to the procedures under this Regulation, including the services undertaken by Member States’ competent authorities when acting as evaluating competent authority.
Države članice vlagateljem neposredno zaračunajo pristojbine za storitve, ki jih opravljajo v zvezi s postopki iz te uredbe, vključno s storitvami, katere opravljajo pristojni organi držav članic, ki delujejo kot ocenjevalni pristojni organi.
Based on the principles set out in paragraph 3, the Commission shall issue guidance concerning a harmonised structure of fees.
Komisija na podlagi načel iz odstavka 3 izda smernice za usklajenost strukture pristojbin.
Member States may levy annual fees with respect to biocidal products made available on their markets.
Države članice lahko zaračunajo letne pristojbine v zvezi z biocidnimi proizvodi, ki so dostopni na njihovih trgih.
Member States may collect charges for other services they provide.
Države članice lahko zahtevajo tudi takse za druge storitve, ki jih zagotavljajo.
Member States shall set and publish the amount of fees payable to their competent authorities.
Države članice določijo in objavijo zneske pristojbin, ki se plačujejo njihovim pristojnim organom.
Both the implementing Regulation referred to in paragraph 1 and Member States’ own rules concerning fees shall respect the following principles:
Tako v izvedbeni uredbi iz odstavka 1 kot tudi v pravilih držav članic glede pristojbin se upoštevajo naslednja načela:
fees shall be set at such a level as to ensure that the revenue derived from the fees is, in principle, sufficient to cover the cost of the services delivered and shall not exceed what is necessary to cover those costs;
pristojbine se določijo na takšni ravni, da z njimi povezani prihodki načeloma zadostujejo za kritje stroškov opravljenih storitev in ne presegajo tistega, kar je potrebno za kritje teh stroškov;
partial reimbursement of the fee if the applicant fails to submit the information requested within the specified time limit;
pristojbina se delno povrne, kadar vlagatelj zahtevanih informacij ne predloži v določenem roku;
the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases;
ustrezno se upoštevajo posebne potrebe MSP, vključno z možnostjo razdelitve plačil na več obrokov in faz;
the structure and amount of fees shall take into account whether information has been submitted jointly or separately;
pri strukturi in znesku pristojbin se upošteva, ali so bile informacije predložene skupaj ali ločeno;
in duly justified circumstances, and where it is accepted by the Agency or the competent authority, the whole fee or a part of it may be waived; and
v ustrezno utemeljenih okoliščinah in kadar to odobri Agencija ali pristojni organ, se lahko plačilo pristojbine v celoti ali delno oprosti in
the deadlines for the payment of fees shall be fixed taking due account of the deadlines of the procedures provided for in this Regulation.
roki za plačilo pristojbin se določijo ob upoštevanju rokov postopkov iz te uredbe.
Member States shall designate a competent authority or competent authorities responsible for the application of this Regulation.
Države članice imenujejo pristojni organ ali pristojne organe, odgovorne za izvajanje te uredbe.
Member States shall ensure that competent authorities have a sufficient number of suitably qualified and experienced staff so that the obligations laid down in this Regulation can be carried out efficiently and effectively.
Države članice zagotovijo, da imajo pristojni organi zadostno število ustrezno usposobljenega in izkušenega osebja, da se obveznosti, določene v tej uredbi, lahko izvedejo učinkovito in uspešno.
Competent authorities shall provide advice to applicants, in particular to SMEs, and to any other interested parties on their respective responsibilities and obligations under this Regulation.
Pristojni organi svetujejo vlagateljem, zlasti MSP, ter drugim zainteresiranim stranem glede njihovih odgovornosti in obveznosti, ki izhajajo iz te uredbe.
That shall include the provision of advice about the possibility of adapting the data requirements of Articles 6 and 20, the grounds on which such an adaptation can be made, and on how to prepare a proposal.
V to je vključeno svetovanje glede možnosti prilagoditve zahtev glede podatkov iz členov 6 in 20, utemeljitev, na podlagi katerih se lahko zaprosi za takšno prilagoditev, in glede priprave takšnega predloga.
It shall be in addition to the advice and assistance that the Secretariat of the Agency shall provide in accordance with Article 76(1)(d).
Dopolnjuje se s svetovanjem in pomočjo, ki ju zagotavlja sekretariat Agencije v skladu s členom 76(1)(d).
Competent authorities may in particular provide advice by establishing helpdesks.
Pristojni organi lahko svetovanje zagotovijo zlasti z vzpostavitvijo služb za pomoč uporabnikom.
Helpdesks already established under Regulation (EC) No 1907/2006 may act as helpdesks under this Regulation.
Službe za pomoč uporabnikom, ki so že bile ustanovljene na podlagi Uredbe (ES) št. 1907/2006, lahko delujejo kot službe za pomoč uporabnikom na podlagi te uredbe.
The Commission shall make publicly available a list of competent authorities and helpdesks.
Komisija da javnosti na voljo seznam pristojnih organov in služb za pomoč uporabnikom.
The Commission shall be assisted by the Standing Committee on Biocidal Products (‘the committee’).
Komisiji pomaga stalni odbor za biocidne proizvode (v nadaljnjem besedilu: odbor).
That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
Odbor je odbor v smislu Uredbe (EU) št. 182/2011.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Kadar odbor ne poda nobenega mnenja, Komisija ne sprejme osnutka izvedbenega akta in se uporabi tretji pododstavek člena 5(4) Uredbe (EU) št. 182/2011.
Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011 shall apply.
Pri sklicevanju na ta odstavek se uporablja člen 8 Uredbe (EU) št. 182/2011.
The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Prenos pooblastila se samodejno podaljša za enako obdobje, razen če Evropski parlament ali Svet nasprotuje temu podaljšanju najpozneje tri mesece prek koncem vsakega obdobja.
The delegation of power referred to in Article 3(4), Article 5(3), Article 6(4), Article 21(3), Article 23(5), Article 28(1) and (3), Article 40, Article 56(4), Article 71(9), Article 85 and Article 89(1) may be revoked at any time by the European Parliament or by the Council.
Pooblastilo iz člena 3(4), člena 5(3), člena 6(4), člena 21(3), člena 23(5), člena 28(1) in (3), člena 40, člena 56(4), člena 71(9), člena 85 in člena 89(1) lahko kadar koli prekliče Evropski parlament ali Svet.