natgillin/translations-raw huggingface dataset:
vloge za vključitev v Prilogo I aktivnih snovi, ki izpolnjujejo pogoje iz člena 28 in pregled vključitve takšnih aktivnih snovi v Prilogo I;
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;
določitev aktivnih snovi, ki so možne snovi za zamenjavo;
identification of active substances which are candidates for substitution;
vloge za dovoljenje Unije za biocidne proizvode ter za podaljšanje, preklic in spremembo dovoljenj Unije, razen v primeru vlog za upravne spremembe;
applications for Union authorisation of biocidal products and for renewal, cancellation and amendments of Union authorisations, except where the applications are for administrative changes;
znanstvene in tehnične zadeve v zvezi z medsebojnim priznavanjem v skladu s členom 38;
scientific and technical matters concerning mutual recognition in accordance with Article 38;
na zahtevo Komisije ali pristojnih organov držav članic o vseh drugih vprašanjih, ki izhajajo iz izvajanja te uredbe, v zvezi s tveganji za zdravje človeka ali živali in okolje ali tehničnimi smernicami.
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 risks to human or animal health or the environment or technical guidance.
Vsaka država članica je upravičena, da imenuje člana Odbora za biocidne proizvode.
Each Member State shall be entitled to appoint a member of the Biocidal Products Committee.
Države članice lahko imenujejo tudi njegovega namestnika.
Member States may also appoint an alternate member.
Zaradi lažjega opravljanja dela se lahko Odbor po odločitvi upravnega odbora Agencije in v dogovoru s Komisijo razdeli v dva ali več vzporednih odborov.
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.
Vsak vzporedni odbor je odgovoren za naloge Odbora za biocidne proizvode, ki so mu dodeljene.
Each parallel committee shall be responsible for the tasks of the Biocidal Products Committee assigned to it.
Vsaka država članica lahko imenuje po enega člana za vsak vzporedni odbor.
Each Member State shall be entitled to appoint one Member for each of the parallel committees.
Ista oseba je lahko imenovana v več vzporednih odborov.
The same person may be appointed to more than one parallel committee.
Člani odbora so imenovani na podlagi svojih izkušenj pri opravljanju nalog iz odstavka 1 in so lahko zaposleni pri pristojnem organu.
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.
V pomoč so jim znanstvena in tehnična sredstva, ki so na razpolago državam članicam.
They shall be supported by the scientific and technical resources available to Member States.
V ta namen države članice članom Odbora, ki so jih imenovale, zagotovijo ustrezna znanstvena in tehnična sredstva.
To this end, Member States shall provide adequate scientific and technical resources to Committee members that they have nominated.
Sekretariat Agencije
Secretariat of the Agency
Sekretariat Agencije iz točke (g) člena 76(1) Uredbe (ES) št. 1907/2006 opravlja naslednje naloge:
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:
vzpostavitev in vzdrževanje registra biocidnih proizvodov;
establishing and maintaining the Register for Biocidal Products;
opravljanje nalog v zvezi z validacijo vlog iz členov 7(3) in (4), 13(3), 43(3) in (4) ter 45(3) te uredbe;
performing the tasks relating to the validation of the applications referred to in Articles 7(3) and (4), 13(3), 43(3) and (4), and 45(3) of this Regulation;
ugotavljanje tehnične ekvivalence;
establishing technical equivalence;
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 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;
svetovanje in pomoč vlagateljem, zlasti MSP, ki zaprosijo za odobritev aktivne snovi ali njeno vključitev v Prilogo I te uredbe ali za dovoljenje Unije;
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;
vzpostavitev in vzdrževanje zbirk podatkov z informacijami o aktivnih snoveh in biocidnih proizvodih;
establishing and maintaining database(s) with information on active substances and 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;
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;
uradno obveščanje o sklepih Agencije;
notification of decisions taken by the Agency;
Sekretariat da informacije iz člena 67(1) in (3) brezplačno na voljo javnosti prek interneta, razen kadar je zahtevek na podlagi člena 66(4) utemeljen.
The Secretariat shall make the information identified in Article 67(1) and (3) publicly available, free of charge, over the internet, except where a request made under Article 66(4) is considered justified.
Agencija na zahtevo omogoči dostop do drugih informacij v skladu s členom 66.
The Agency shall make other information available on request in accordance with Article 66.
Pritožbe proti sklepom Agencije, sprejetim v skladu s členi 7(2), 13(3), 26(2), 43(2), 45(3), 54(4), 63(3) in 64(1), se vložijo pri Odboru za pritožbe, ustanovljenem v skladu z Uredbo (ES) št. 1907/2006.
Appeals against decisions of the Agency taken pursuant to Articles 7(2), 13(3), 26(2), 43(2), 45(3), 54 (4), 63(3) and 64(1) shall lie with the Board of Appeal set up in accordance with Regulation (EC) No 1907/2006.
Členi 92(1) in (2), 93 in 94 Uredbe (ES) št. 1907/2006 se uporabljajo za pritožbene postopke, vložene na podlagi te uredbe.
Articles 92(1) and (2), 93 and 94 of Regulation (EC) No 1907/2006 shall apply to appeal procedures lodged under this Regulation.
Od osebe, ki vloži pritožbo, se lahko zahteva plačilo pristojbine v skladu s členom 80(1) te uredbe.
A fee may be payable, in accordance with Article 80(1) of this Regulation, by the person bringing an appeal.
Za namene te uredbe prihodke Agencije sestavljajo:
For the purposes of this Regulation, the revenues of the Agency shall consist of:
subvencija Unije, vključena v splošni proračun Evropske unije (oddelek Komisija);
a subsidy from the Union, entered in the general budget of the European Union (Commission Section);
pristojbine, plačane Agenciji v skladu s to uredbo;
the fees paid to the Agency in accordance with this Regulation;
vse takse, plačane Agenciji za storitve, ki jih opravi na podlagi te uredbe;
any charges paid to the Agency for services that it provides under this Regulation;
vsi prostovoljni prispevki držav članic.
any voluntary contributions from Member States.
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 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 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 Article 96(1) of Regulation (EC) No 1907/2006 shall not be used for carrying out tasks under this Regulation.
Prihodki Agencije iz prvega odstavka tega člena se ne uporabljajo za opravljanje nalog na podlagi Uredbe (ES) št. 1907/2006.
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.
Formati in programska oprema za predložitev informacij Agenciji
Formats and software for submission of information to the Agency
Agencija določi formate in programske pakete ter jih da na voljo brezplačno na svoji spletni strani.
The Agency shall specify formats and software packages and make them available free of charge on its website for submissions to the Agency.
Pristojni organi in vlagatelji uporabljajo te formate in pakete pri predložitvah v skladu s to uredbo.
The competent authorities and applicants shall use these formats and packages in their submissions pursuant to this Regulation.
Tehnična dokumentacija iz členov 6(1) in 20 se predloži z uporabo programske opreme IUCLID.
The technical dossier referred to in Articles 6(1) and 20 shall be submitted using the IUCLID software package.
POGLAVJE XVII
CHAPTER XVII
Pristojbine in takse
Fees and charges
Komisija na podlagi načel iz odstavka 3 sprejme izvedbeno uredbo, v kateri določi:
The Commission shall adopt, on the basis of the principles set out in paragraph 3, an implementing Regulation specifying:
pristojbine, ki se plačujejo Agenciji, vključno z letno pristojbino
the fees payable to the Agency, including an annual fee
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
for products granted an Union authorisation in accordance with Chapter VIII and a fee for applications for mutual recognition in accordance with Chapter VII
pravila glede pogojev za nižje pristojbine, oprostitev pristojbin in povračilo za člana Odbora za biocidne proizvode, ki opravlja nalogo poročevalca; in
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
pogoje plačila.
conditions of payment.
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 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 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;
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;
pristojbina se delno povrne, kadar vlagatelj zahtevanih informacij ne predloži v določenem roku;
partial reimbursement of the fee if the applicant fails to submit the information requested within the specified time limit;
ustrezno se upoštevajo posebne potrebe MSP
the specific needs of SMEs shall be taken into account, as appropriate
, vključno z možnostjo plačil v več obrokih in fazah
, including the possibility of splitting of payments into several instalments and phases
pri strukturi in znesku pristojbin se upošteva, ali so bile informacije predložene skupaj ali ločeno;
the structure and amount of fees shall take into account whether information has been submitted jointly or separately;
v ustrezno utemeljenih okoliščinah in kadar to odobri Agencija ali pristojni organ, se lahko plačilo pristojbine v celoti ali delno oprosti in
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
določijo ob upoštevanju rokov postopkov iz te uredbe.
the deadlines for the payment of fees ▌ shall be fixed taking due account of the deadlines of the procedures provided for in this Regulation.
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.
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.
Pristojni organi svetujejo vlagateljem, zlasti malim in srednjim podjetjem, ter drugim zainteresiranim stranem glede njihovih odgovornosti in obveznosti, ki izhajajo iz te uredbe.
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.
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.
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.
Dopolnjuje se s svetovanjem in pomočjo, ki ju zagotavlja sekretariat Agencije v skladu s členom 76(1)(d).
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).
Pristojni organi lahko svetovanje zagotovijo zlasti z vzpostavitvijo služb za pomoč uporabnikom.
Competent authorities may in particular provide advice by establishing helpdesks.
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.
Helpdesks already established under Regulation (EC) No 1907/2006 may act as helpdesks under this Regulation.
Komisiji sporočijo imena in naslove imenovanih pristojnih organov in, če obstajajo, služb za pomoč uporabnikom.
Member States shall, without undue delay, inform the Commission of any changes to the names and addresses of the competent authorities or helpdesks.
Komisija da javnosti na voljo seznam pristojnih organov in služb za pomoč uporabnikom.
The Commission shall make publicly available a list of competent authorities and helpdesks.
Komisiji pomaga stalni odbor za biocidne proizvode (v nadaljnjem besedilu: odbor).
The Commission shall be assisted by the Standing Committee on Biocidal Products (‘the committee’).
Odbor je odbor v smislu Uredbe (EU) št. 182/2011.
That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
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 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.
Pri sklicevanju na ta odstavek se uporablja člen 8 Uredbe (EU) št. 182/2011.
Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011 shall apply.
Član 83
Article 83
Pooblastilo iz členov 5(3), 21(3), 23(5), 28(1) in (3), 40, 56(4), 71(9), 85 in 89(1) se prenese na Komisijo za obdobje petih let od … * UL: vstaviti datum – dan začetka veljavnosti te uredbe.
The delegation of power referred to in Articles 5(3), 21(3), 23(5), 28(1) and (3), Article 40, Articles 56(4), 71(9), Article 85 and Article 89(1) shall be conferred on the Commission for a period of five years from… * OJ: Insert the date - the day of the entry into force of this Regulation.
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 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.
Pooblastilo iz členov 5(3), 21(3), 23(5), 28(1) in (3), 40, 56(4), 71(9), 85 in 89(1) lahko kadar koli prekliče Evropski parlament ali Svet.
The delegation of powers referred to in Articles 5(3), 21(3), 23(5), 28(1) and (3), Article 40, Articles 56(4), 71(9), Article 85 and Article 89(1) may be revoked at any time by the European Parliament or by the Council.
Z odločitvijo o preklicu preneha veljati prenos pooblastila, naveden v odločitvi.
A decision of revocation shall put an end to the delegation of the power specified in that decision.
Odločitev začne učinkovati dan po njeni objavi v
It shall take effect the day following the publication of the decision in the
ali na poznejši dan, ki je v njej določen.
or at a later date specified therein.
Delegirani akt, sprejet v skladu s členi 5(3), 21(3), 23(5), 28(1) in (3), 40, 56(4), 71(9), 85 in 89(1), začne veljati le, če niti Evropski parlament niti Svet ne nasprotuje delegiranemu aktu v roku dveh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu o tem aktu, ali če sta pred iztekom tega roka tako Evropski parlament kot Svet obvestila Komisijo, da ne bosta nasprotovala.
A delegated act adopted pursuant to Articles 5(3), 21(3), 23(5), 28(1) and (3), Article 40, Articles 56(4), 71(9), Article 85 and Article 89(1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
Uradno obvestilo o delegiranem aktu Evropskemu parlamentu in Svetu navaja razloge za uporabo postopka v nujnih primerih.
The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
Evropski parlament ali Svet lahko nasprotuje delegiranemu aktu v skladu s postopkom iz člena 83(5).
Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 83(5).
Da bi omogočili prilagoditev določb te uredbe znanstvenemu in tehničnemu napredku, se na Komisijo prenese pooblastilo, za sprejemanje delegiranih aktov v skladu s členom 83 v zvezi s prilagoditvijo prilog II, III in IV temu znanstvenemu in tehničnemu napredku.
In order to allow the provisions of this Regulation to be adapted to scientific and technical progress, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the adaptation of Annexes II, III and IV to such scientific and technical progress.
Aktivne snovi, vključene v Prilogo I k Direktivi 98/8/ES
Active substances included in Annex I to Directive 98/8/EC
Za aktivne snovi, vključene v Prilogo I k Direktivi 98/8/ES, se šteje, da so bile odobrene v skladu s to uredbo, in se vključijo v seznam iz člena 9(2).
The active substances included in Annex I to Directive 98/8/EC shall be deemed to have been approved under this Regulation and shall be included in the list referred to in Article 9(2).
Države članice sprejmejo določbe o kaznih za kršitve določb te uredbe in uvedejo vse potrebne ukrepe, da bi zagotovile izvajanje teh določb.
Member States shall lay down the provisions on penalties applicable to infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented.
Države članice Komisijo najpozneje …
The Member States shall notify those provisions to the Commission no later than …
UL: vstaviti datum – dan začetka uporabe te uredbe.
OJ: Insert the date -the day of application of this Regulation.
obvestijo o teh določbah in jo nemudoma obvestijo tudi glede vseh poznejših sprememb, ki vplivajo na te določbe.
and shall notify the Commission without delay of any subsequent amendment affecting them.
Kadar ima država članica na podlagi novih dokazov utemeljene razloge za domnevo, da biocidni proizvod pomeni resno takojšnje ali dolgoročno tveganje za zdravje človeka ali živali, zlasti za ranljive skupine, ali za okolje, čeprav je dovoljen v skladu s to uredbo, lahko sprejme ustrezne začasne ukrepe.
Where, on the basis of new evidence, a Member State has justifiable grounds to consider that a biocidal product, although authorised in accordance with this Regulation, constitutes a serious immediate or long-term risk to human or animal health, in particular to vulnerable groups, or to the environment, it may take appropriate provisional measures.
Države članice nemudoma ustrezno obvestijo Komisijo in druge države članice ter na podlagi novih dokazov navedejo razloge za svojo odločitev.
The Member State shall, without delay, inform the Commission and the other Member States accordingly and give reasons for its decision based on the new evidence.
Komisija z izvedbenimi akti bodisi dovoli začasne ukrepe za časovno obdobje, opredeljeno v odločitvi, bodisi zahteva, da država članica prekliče začasni ukrep.
The Commission shall, by means of implementing acts, either permit the provisional measure for a time period defined in the decision or require the Member State to revoke the provisional measure.
Komisija nadaljuje izvajanje delovnega programa za sistematično preverjanje vseh obstoječih aktivnih snovi, ki ga je začela v skladu s členom 16(2) Direktive 98/8/ES, da bi ga izvedla do 14. maja 2014.
The Commission shall carry on with the work programme for the systematic examination of all existing active substances commenced in accordance with Article 16(2) of Directive 98/8/EC with the aim of achieving it by 14 May 2014.
V ta namen se na Komisijo prenese pooblastilo, za sprejemanje delegiranih aktov v skladu s členom 83 v zvezi z izvedbo delovnega programa in določanjem s tem povezanih pravic in obveznosti pristojnih organov in udeležencev v programu.
To that end, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the carrying out of the work programme and specification of the related rights and obligations of the competent authorities and the participants in the programme.
Glede na napredek pri izvajanju delovnega programa se na Komisijo prenese pooblastilo, za sprejemanje delegiranih aktov v skladu s členom 83 v zvezi s podaljšanjem trajanja delovnega programa za določen čas.
Depending upon the progress of the work programme, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the extension of the duration of the work programme for a determined period.
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, in sicer največ dve leti po datumu odobritve zadnje aktivne snovi tega biocidnega proizvoda.
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 a given biocidal product available on the market until two years after the date of approval of the last of the active substances in that biocidal product.