natgillin/translations-raw huggingface dataset:
subvencijo Unije, vključeno v splošen proračun Evropske unije (oddelek Komisija);
a subsidy from the Union, entered in the general budget of the European Union (Commission Section);
vse takse, plačane Agenciji za storitve na podlagi te uredbe;
any charges paid to the Agency for services provided under this Regulation;
prostovoljni prispevek držav članic.
any voluntary contribution from the Member States.
Prihodek in izdatek za dejavnosti, povezane s to uredbo, in za dejavnosti, povezane z dejavnostmi na podlagi Uredbe (ES) št. 1907/2006, se v proračunu Agencije obravnavata ločeno z ločenim proračunskim in računovodskim poročilom.
Revenue and expenditure for activities related to this Regulation and those relating to activities under Regulation (EC) No 1907/2006 shall be dealt with separately in the Agency's budget with a separate budgetary and accounting reporting.
Prihodek Agencije iz člena 96(1) Uredbe (ES) št. 1907/2006 se ne uporablja 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.
Agencija določi oblike in jih da brezplačno na voljo, poleg tega določi programske pakete, in jih da brezplačno na voljo na svoji spletni strani za vloge, ki se vložijo pri Agenciji.
The Agency shall specify formats and make them available free of charge, and shall specify software packages and make them available on its website for submissions to the Agency.
Pristojni organi in predlagatelji uporabijo te oblike in pakete pri svojih vlogah, ki se vložijo pri Agenciji na podlagi te uredbe.
The competent authorities and applicants shall use these formats and packages in their submissions to the Agency pursuant to this Regulation.
Oblika tehnične dokumentacije iz členov 6(1), 11(1), 18 in 36(4) je IUCLID.
The format of the technical dossier referred to in Articles 6(1), 11(1), 18 and 36(4) shall be IUCLID.
Poglavje XIV
Chapter XIV
Komisija določi pravila za:
The Commission shall establish rules concerning:
sistem pristojbin, ki se plačujejo Agenciji;
the system of fees payable to the Agency;
usklajeno strukturo pristojbin;
the harmonised structure of fees;
okoliščine, v katerih se del pristojbin prenese na pristojni organ države članice, ki izvaja ocenjevanje;
the circumstances under which a proportion of the fees is to be transferred to the competent authority of the evaluating Member State;
delno nadomestilo za pristojbino, kadar predlagatelj med validacijo vloge zahtevanih informacij ne predloži v roku.
the partial reimbursement of the fee in the event that the applicant fails to submit the information requested within the deadline during validation of the application.
Usklajena struktura pristojbin in pogojev plačila temelji na naslednjih načelih:
The harmonised structure of fees and conditions of payment shall be based on the following principles:
znižana pristojbina se določi za mala in srednje velika podjetja v smislu Priporočila 2003/361/ES;
a reduced fee shall be set for small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC;
to nikakor ne vpliva na odgovornost ustreznega pristojnega organa, da opravi natančno oceno v skladu z določbami te uredbe;
this shall have no bearing on the responsibility of the relevant competent authority to carry out a careful assessment in accordance with the provisions of this Regulation;
struktura pristojbin upošteva, ali so bile informacije predložene skupaj ali ločeno;
the fee structure shall take into account whether information has been submitted jointly or separately;
v strukturi pristojbin se upošteva, ali izdelek, za katerega se vloži vloga za izdajo dovoljenja, ustreza merilom za izdelek z manjšim tveganjem;
the fee structure shall take into account whether the product submitted for authorisation complies with the criteria for a low-risk product;
v ustrezno utemeljenih okoliščinah in kadar to odobri pristojni organ ali Agencija, se lahko plačilo pristojbine opusti;
in duly justified circumstances and where it is accepted by the competent authority or the Agency, it shall be possible to waive the fee;
pri sestavi in znesku pristojbin se upošteva delo, ki ga ta uredba zahteva od Agencije in pristojnih organov, določita pa se na taki ravni, da z njimi povezani prihodki, v kombinaciji z drugimi viri prihodkov Agencije na podlagi te uredbe, zadostujejo za kritje stroškov opravljenih storitev.
the structure and amount of the fees shall take account of the work required by this Regulation to be carried out by the Agency and the competent authorities and shall be fixed at such 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.
Države članice tiste, ki so dali v promet biocidne pripravke ali si za to prizadevajo, ter tiste, ki podpirajo vključitev aktivnih snovi v Prilogo I, obvežejo k plačilu pristojbin v skladu z usklajeno strukturo pristojbin in pogojev plačila, ki se sprejmejo v skladu z odstavkom 1.
Member States shall oblige those who have placed or are seeking to place biocidal products on the market and those supporting inclusion of active substances in Annex I to pay fees in accordance with the harmonised structure of fees and conditions of payment to be adopted in accordance with paragraph 1.
V skladu s pravili iz odstavka 1 Agencija obveže tiste, ki so dali v promet biocidne pripravke ali si za to prizadevajo, in tiste, ki podpirajo vključitev aktivnih snovi iz Priloge I, k plačilu pristojbin.
In accordance with the rules referred to in paragraph 1, the Agency shall oblige those who have placed or are seeking to place biocidal products on the market and those supporting inclusion of active substances in Annex I to pay fees.
Struktura in znesek pristojbin, plačljivih Agenciji, se določita v skladu z odstavkom 1.
The structure and the amount of fees payable to the Agency shall be determined in accordance with paragraph 1.
Države članice imenujejo pristojni organ ali pristojne organe, odgovorne za izvajanje te uredbe.
Member States shall designate a competent authority or competent authorities responsible for the application of this Regulation.
Države članice do 1. januarja 2013 Komisiji sporočijo imena in naslove imenovanih pristojnih organov.
Member States shall inform the Commission of the names and addresses of the designated competent authorities by 1 January 2013.
Države članice brez nepotrebne zamude obvestijo Komisijo o vseh spremembah imen in naslovov pristojnih organov.
Member States shall, without undue delay, inform the Commission of any changes to the names and addresses of the competent authorities.
Komisija da javnosti na voljo seznam pristojnih organov.
The Commission shall make publicly available the list of the competent authorities.
Pooblastilo za sprejemanje delegiranih aktov iz členov 5(1)(d), 6(4), 8(5), 12(5), 13(1), 14, 16(10), 19(3), 21(5), 25(6), 28(8), 42(1), 46(4), 60(5), 71(1), 77 in 82(1) se Komisiji podeli za obdobje petih let po začetku veljavnosti te uredbe.
The power to adopt the delegated acts referred to in Articles 5(1)(d), 6(4), 8(5), 12(5), 13(1), 14, 16(10), 19(3), 21(5), 25(6), 28(8), 42(1), 46(4), 60(5), 71(1), 77 and 82(1) shall be conferred on the Commission for a period of five years following the entry into force of this Regulation.
Komisija najpozneje šest mesecev pred iztekom petletnega obdobja pripravi poročilo o prenesenih pooblastilih.
The Commission shall draw up a report in respect of the delegated power at the latest six months before the end of the five year period.
Prenos pooblastil se samodejno podaljša za enako dolgo obdobje, razen če ga Evropski parlament ali Svet ne prekliče v skladu s členom 74.
The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 74.
Pooblastilo za sprejemanje delegiranih aktov se na Komisijo prenese pod pogoji iz členov 74 in 75.
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 74 and 75.
Evropski parlament ali Svet lahko kadarkoli prekliče prenos pooblastil iz členov 5(1)(d), 6(4), 8(5), 12(5), 13(1), 14, 16(10), 19(3), 21(5), 25(6), 28(8), 42(1), 46(4), 60(5), 71(1), 77 in 82(1).
The delegation of power referred to in Articles 5(1)(d), 6(4), 8(5), 12(5), 13(1), 14, 16(10), 19(3), 21(5), 25(6), 28(8), 42(1), 46(4), 60(5), 71(1), 77 and 82(1) may be revoked at any time by the European Parliament or by the Council.
Institucija, ki je začela notranji postopek za odločanje, ali naj se prenos pooblastil prekliče, si prizadeva o tem obvestiti drugo institucijo in Komisijo v doglednem času pred sprejetjem končne odločitve, pri čemer navede prenesena pooblastila, ki bi lahko bila preklicana, ter morebitne razloge za preklic.
The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and possible reasons for a revocation.
Z odločitvijo o preklicu pooblastil prenehajo veljati pooblastila, navedena v tej odločitvi.
The decision of revocation shall put an end to the delegation of the power specified in that decision.
Na pobudo Evropskega parlamenta ali Sveta se to obdobje podaljša za en mesec.
At the initiative of the European Parliament or the Council that period shall be extended by one month.
Če po izteku obdobja iz prvega odstavka niti Evropski parlament niti Svet ne nasprotuje delegiranemu aktu, se ta objavi v Uradnem listu Evropske unije in začne veljati na tam navedeni datum.
If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.
Če Evropski parlament ali Svet v obdobju iz prvega odstavka delegiranemu aktu nasprotuje, ta ne začne veljati.
If either the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force.
Komisiji pomaga stalni odbor za biocidne pripravke.
The Commission shall be assisted by the Standing Committee on Biocidal Products.
Člen 77
Article 77 Adaptation to scientific and technical progress
Prilagajanje znanstvenemu in tehničnemu napredku
In order to take account of technical progress,
zaradi upoštevanja tehničnega napredka z delegiranimi akti v skladu s členom 73 in pod pogoji iz členov 74 in 75
shall, by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75,
priloge prilagodi znanstvenemu in tehničnemu napredku.
adapt the Annexes to scientific and technical progress.
Do 1. januarja 2013 Komisija v skladu s postopkom iz člena 76(3) spremeni Prilogo I, ki začne veljati na dan začetka uporabe te uredbe, da se upoštevajo vse spremembe Priloge I, sprejete na podlagi Direktive 98/8/ES od začetka veljavnosti te uredbe.
By 1 January 2013, the Commission shall, in accordance with the procedure referred to in Article 76(3), amend Annex I with effect from the date of applicability of this Regulation in order to take into account any amendment to Annex I adopted under Directive 98/8/EC since the entry into force of this Regulation.
Države članice določijo določbe za sankcije za kršitve določb te uredbe in sprejmejo ukrepe, ki so potrebni za zagotovitev, da se ti ukrepi izvajajo.
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.
Predvidene sankcije morajo biti učinkovite, sorazmerne in odvračalne.
The penalties provided for must be effective, proportionate and dissuasive.
Države članice Komisiji sporočijo te določbe najpozneje do 1. decembra 2015 in ji takoj sporočijo tudi vse poznejše spremembe, ki vplivajo na te določbe.
The Member States shall notify those provisions to the Commission no later than 1 December 2015 and shall notify the Commission without delay of any subsequent amendment affecting them.
Države članice vzpostavijo nacionalne službe za pomoč uporabnikom, ki predlagateljem, predvsem MSP, in vsem drugim zainteresiranim stranem svetujejo o njihovih odgovornostih in obveznostih iz te uredbe.
Member States shall establish national helpdesks to provide advice to applicants, in particular to SMEs, and any other interested parties on their respective responsibilities and obligations under this Regulation.
Te nacionalne službe za pomoč uporabnikom so dopolnilo pomoči Agencije iz člena 67(2)(d).
Those national helpdesks shall be in addition to any assistance provided by the Agency under Article 67(2)(d).
Kadar ima država članica na podlagi novih dokazov utemeljene razloge za domnevo, da biocidni pripravek
Where, on the basis of new evidence, a Member State has justifiable grounds to consider that a biocidal product, although satisfying the requirements of this Regulation, constitutes a serious
takoj ali pozneje
immediate or long-term
pomeni resno tveganje za zdravje ljudi
risk to human
, zlasti otrok in ranljivih skupin,
health, in particular as regards children and vulnerable groups,
ali zdravje živali ali za okolje
or animal health or to the environment,
ali glede doseganja standardov kakovosti iz Direktive 2000/60/ES, in
or to achieving the quality standards laid down in Directive 2000/60/EC,
Države članice o tem nemudoma obvestijo Komisijo in druge države članice in navedejo razloge za svojo odločitev ▌.
The Member State shall without delay inform the Commission and the other Member States thereof and give reasons for its decision ▌.
Za zagotovitev gladkega prehoda lahko
In order to ensure a smooth transition,
z delegiranimi akti v skladu s členom 73 ter pod pogoji iz členov 74 in 75 te uredbe
, by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75 of this Regulation,
ter glede na napredek pri izvajanju delovnega programa odločitev, da se delovni program podaljša za določeno obdobje
depending upon the progress of the work programme, a decision to extend the duration of the work programme for a determined period
Da se pri delovnem programu doseže napredek,
In order to progress with
se Komisija
the work programme, the Commission shall decide
odloči ▌, da se aktivna snov vključi v Prilogo I te uredbe in pod kakšnimi pogoji ali v primerih, ko zahteve iz člena 4 te uredbe niso izpolnjene ali kadar potrebne informacije in podatki niso bili predloženi v predpisanem roku, da se aktivna snov ne vključi v Prilogo I te uredbe.
that an active substance shall be included in Annex I of this Regulation and under which conditions, or, in cases where the requirements of Article 4 of this Regulation are not satisfied or where the requisite information and data have not been submitted within the prescribed period, that such active substance shall not be included in Annex I of this Regulation.
Ne glede na člene 15(1), 16(1) in 18(1) ter ne glede na odstavka 1 in 3 lahko država članica še naprej uporablja svoj trenuten sistem ali prakso dajanja biocidnih pripravkov v promet do dveh let po datumu, ko je začela veljati vključitev v Prilogo I.
By way of derogation from Articles 15(1), 16(1) and 18(1), and without prejudice to paragraphs 1 and 3, a Member State may continue to apply its current system or practice of placing biocidal products on the market until two years after the date on which the inclusion in Annex I becomes effective.
, vendar še niso vključene v Prilogo I k tej uredbi za zadevno vrsto pripravka.
but which are not yet listed in Annex I to this Regulation for that product type.
Ne glede na prvi pododstavek lahko država članica, če se odloči, da aktivne snovi ne bo vključila v Prilogo I te uredbe, še naprej uporablja svoj obstoječ sistem ali prakso dajanja biocidnih pripravkov v promet, in sicer največ 12 mesecev od datuma začetka uporabe odločitve, sprejete v skladu s tretjim pododstavkom odstavka 1.
In derogation from the first subparagraph, in the case of a decision not to include an active substance in Annex I of this Regulation, a Member State may continue to apply its current system or practice of placing biocidal products on the market no longer than 12 months after the applicability date of a decision taken in accordance with the third subparagraph of paragraph 1.
Po odločitvi za vključitev določene aktivne snovi v Prilogo I te uredbe države članice zagotovijo, da se dovoljenja za biocidne pripravke, ki vsebujejo to aktivno snov, izdajo, spremenijo ali prekličejo, kar je ustrezno, v skladu s to uredbo v dveh letih po datumu začetka veljavnosti vključitve.
Following a decision to include a particular active substance in Annex I of this Regulation Member States shall ensure that authorisations for biocidal products containing that active substance are granted, modified or cancelled as appropriate in accordance with this Regulation within two years from the date on which the inclusion becomes effective.
V ta namen se vloge za izdajo dovoljenja za biocidne pripravke, ki vsebujejo le obstoječe aktivne snovi, vložijo pri pristojnih organih držav članic najpozneje na datum, ko začne veljati vključitev aktivnih snovi v Prilogo I.
To that effect, applications for authorisation of biocidal products containing only existing active substances shall be submitted to the competent authorities of the Member States no later than the date which the inclusion of the active substance(s) in Annex I becomes effective.
Če biocidni pripravki vsebujejo več kot eno aktivno snov, se vloge za dovoljenje predložijo najpozneje na dan, ko začne veljati vključitev zadnje aktivne snovi.
In the case of biocidal products containing more than one active substance, applications for authorisation shall be submitted no later than the date on which the inclusion of the last active substance becomes effective.
Biocidni pripravki, za katere vloga za dovoljenje za pripravek ni bila vložena v skladu z drugim pododstavkom, se ne dajejo več v promet ▌ od datuma, ko začne veljati vključitev.
Biocidal products, for which an application for a product authorisation has not been submitted in accordance with the second subparagraph, shall no longer be placed on the market ▌after the date on which the inclusion becomes effective.
Odstranitev, skladiščenje in uporaba obstoječih zalog biocidnih pripravkov, za katere vloga za dovoljenje ni bila vložena v skladu z drugim pododstavkom, so dovoljeni največ
Disposal, storage and use of existing stocks of biocidal products for which an application for authorisation has not been submitted in accordance with the second subparagraph are allowed until
po datumu, ko začne vključitev veljati.
after the date on which the inclusion becomes effective.
Biocidni pripravki, za katere je pristojni organ države članice zavrnil vlogo za izdajo dovoljenja, predloženo na podlagi odstavka 3, ali se je odločil, da ne bo izdal dovoljenja, se prenehajo dajati v promet po šestih mesecih od te zavrnitve ali odločitve.
Biocidal products for which the competent authority of the Member State has rejected an application for authorisation submitted under paragraph 3 or has decided not to grant authorisation, shall no longer be placed on the market with effect from six months after such a rejection or a decision.
Agencija je odgovorna za usklajevanje ocenjevanja dokumentacije, vložene po 1. januarju 2012, in olajša pripravo ocenjevanja, tako da zagotovi organizacijsko in tehnično podporo državam članicam in Komisiji.
The Agency shall be responsible for coordinating the evaluation process of dossiers submitted after 1 January 2012 and shall facilitate the preparation of the evaluation by providing organisational and technical support to the Member States and the Commission.
Dokumentacijo, vloženo za namene Direktive 98/8/ES, za katero se ocenjevanje ne zaključi do 1. januarja 2013, nadalje ocenjujejo pristojni organi v skladu z določbami Direktive 98/8/ES in, kjer je to primerno, Uredbo (ES) št. 1451/2007.
Dossiers submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by 1 January 2013 shall continue to be evaluated by the competent authorities in accordance with the provisions of Directive 98/8/EC and, where relevant, Regulation (EC) No 1451/2007.
Ne glede na odstavek 1 je Agencija prav tako odgovorna za usklajevanje ocenjevanja dokumentacije, ki se predloži za namene Direktive 98/8/ES, katerih ocenjevanje se ne zaključi do 1. januarja 2013, ter olajša pripravo ocenjevanja z zagotavljanjem organizacijske in tehnične podpore državam članicam in Komisiji od 1. januarja 2014.
Notwithstanding paragraph 1, the Agency shall also be responsible for coordinating the evaluation process of dossiers submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by 1 January 2013 and shall facilitate the preparation of the evaluation by providing organisational and technical support to the Member States and the Commission from 1 January 2014.
Biocidni pripravki z nizkim tveganjem, kot so opredeljeni v členu 2(1)(b) Direktive 98/8/ES, se registrirajo v skladu s točko (i) člena 3(2) Direktive 98/8/ES.
Low-risk biocidal products as defined in Article 2(1) (b) of Directive 98/8/EC shall be registered in accordance with point (i) of Article 3(2) of Directive 98/8/EC.
Določbe Direktive 98/8/ES veljajo za te pripravke do izteka registracije.
The provisions of Directive 98/8/EC shall apply to these products until the expiry of the registration.
Registracija se ne obnovi.
The registration shall not be renewable.
Vloge za registracijo biocidnih pripravkov z manjšim tveganjem, kot so opredeljeni v točki (b) člena 2(1) Direktive 98/8/ES se vložijo najpozneje dvanajst mesecev po datumu, ko začne veljati vključitev v Prilogo IA.
Applications for the registration of low-risk biocidal products as defined in point (b) of Article 2(1) of Directive 98/8/EC shall be submitted at the latest twelve months after the date on which the inclusion in Annex IA becomes effective.
Biocidni pripravki z nizkim tveganje, kot so opredeljeni v točki (b) člena 2(1) Direktive 98/8/ES, za katere je bila vložena vloga v skladu s prvim pododstavkom, se lahko še naprej dajejo v promet do datuma odločitve o odobritvi registracije ali njeni zavrnitvi.
Low-risk biocidal products as defined in point (b) of Article 2(1) of Directive 98/8/EC for which an application was submitted in accordance with the first subparagraph may continue to be placed on the market until the date of the decision granting the registration or refusing to grant the registration.
V primeru zavrnitve registracije za dajanje takšnih biocidnih pripravkov z manjšim tveganjem v promet, se takšni biocidni pripravki z nizkim tveganjem prenehajo dajati v promet v šestih mesecih po sprejetju takšne odločitve.
In the case of a refusal to grant a registration to place such low-risk biocidal product on the market, such low-risk biocidal product shall no longer be placed on the market within six months after such decision.
Biocidni pripravki z nizkim tveganjem, kot so opredeljeni v točki (b) člena 2(1) Direktive 98/8/ES, za katere vloga ni bila vložena v skladu s prvim pododstavkom, se lahko še naprej dajejo v promet, in sicer šest mesecev od datuma iz odstavka 1 tega člena.
Low-risk biocidal products as defined in point (b) of Article 2(1) of Directive 98/8/EC for which an application was not submitted in accordance with the first subparagraph may continue to be placed on the market until six months after the date referred to in paragraph 1 of this Article.