natgillin/translations-raw huggingface dataset:
Ko zadevni pristojni organ validira vlogo v skladu s členi 7, 28 ali 42, ali potrdi vlogo v skladu s členi 13, 19 ali 44, se ta prek registra biocidnih proizvodov da na voljo vsem drugim pristojnim organom in Agenciji.
Once the relevant competent authority has validated an application in accordance with Article 7, 28 or 42, or accepted an application in accordance with Article 13, 19 or 44, it shall be made available via the Register for Biocidal Products to all other competent authorities and to the Agency.
Vlagatelji uporabljajo register biocidnih proizvodov za pripravo obrazcev vlog in oddajo vlog ter podatkov za vse postopke , ki jih zajema ta uredba.
Applicants shall use the Register for Biocidal Products to generate application forms and to submit applications and data for all procedures covered by this Regulation.
Pristojni organi v registru biocidnih proizvodov posodabljajo informacije o biocidnih proizvodih, ki so dovoljeni na njihovem ozemlju ali za katere je bilo nacionalno dovoljenje zavrnjeno, spremenjeno, obnovljeno ali preklicano.
Competent authorities shall update the information in the Register for Biocidal Products relating to biocidal products which have been authorised within their territory or for which a national authorisation has been refused, amended, renewed or cancelled.
Komisija posodablja informacije v zvezi z biocidnimi proizvodi, ki so dovoljeni v Uniji ali za katere je bilo dovoljenje Unije zavrnjeno, spremenjeno, obnovljeno ali preklicano.
The Commission shall update the information relating to biocidal products which have been authorised in the Union or for which a Union authorisation has been refused, amended, renewed or cancelled.
Pristojni organi in Komisija uporabijo register biocidnih proizvodov za registriranje in posredovanje odločitev, sprejetih v zvezi z odobritvami biocidnih proizvodov, ter posodobijo informacije v registru, kadar se takšna odločitev sprejme.
The competent authorities and the Commission shall use the Register for Biocidal Products to record and communicate the decisions they have taken in relation to the authorisations of biocidal products and shall update the information in the Register at the time such decisions are taken.
Pristojni organi v registru biocidnih proizvodov zlasti posodabljajo informacije o biocidnih proizvodih, ki so dovoljeni na njihovem ozemlju ali za katere je bilo nacionalno dovoljenje zavrnjeno, spremenjeno, obnovljeno ali preklicano , ali za katere je bilo odobreno, zavrnjeno ali preklicano dovoljenje za vzporedno trgovanje .
The competent authorities shall in particular update the information in the Register for Biocidal Products relating to biocidal products which have been authorised within their territory; for which a national authorisation has been refused, amended, renewed or cancelled , or for which a parallel trade permit has been granted, refused or cancelled.
Komisija zlasti posodablja informacije v zvezi z biocidnimi proizvodi, ki so dovoljeni v Uniji ali za katere je bilo dovoljenje Unije zavrnjeno, spremenjeno, obnovljeno ali preklicano.
The Commission shall , in particular, update the information relating to biocidal products which have been authorised in the Union or for which a Union authorisation has been refused, amended, renewed or cancelled.
Informacije, ki se vnesejo v register, vključujejo, kjer je primerno:
The information to be introduced into the Registry shall include, as appropriate:
(a) pogoje za odobritve;
(a) the terms and conditions of the authorisations;
(b) povzetek značilnosti biocidnega proizvoda iz člena 21(2);
(b) the summary of the biocidal product characteristics referred to in Article 21 (2);
(c) poročilo o oceni biocidnega proizvoda;
(c) the assessment report of the biocidal product;
(d) metode analize iz člena 18(1)(c).
(d) the methods of analysis referred to in Article 18(1)(c).
Informacije iz tega odstavka se prek registra za biocidne proizvode posredujejo tudi vlagatelju.
The information referred to in this paragraph shall also be made available to the applicant through the Register for Biocidal Products.
Svet je člen 70 spremenil tako, da se register za biocidne proizvode uporablja za izmenjavo informacij v povezavi z uredbo.
Article 70 has been changed by the Council making the Register for Biocidal Products the tool to be used for exchanging information in relation to the Regulation.
S predlaganimi predlogi sprememb se namerava pojasniti način uporabe registra.
The amendments proposed aim to clarify the way that the Register is to be used.
Člen 75 – odstavek 1 – točka j a (novo)
Article 75 – paragraph 1 – point j a (new)
(ja) svetovanje in zagotavljanje orodij za fazo uporabe, zlasti:
(ja) providing guidance and tools for the use phase, particularly:
– spremljanje uporabe biocidnih proizvodov,
- monitoring biocidal product use,
– najboljše prakse za uporabo biocidnih proizvodov, da bi njihovo uporabo omejili na najmanjši potrebni odmerek,
- best practice of biocidal product use to limit use of such products to the minimum necessary dose,
– zatiranje škodljivcev na občutljivih območjih, kot so šole, delovna mesta, vrtci, javni prostori, jezera, kanali in rečna obrežja, domovi za ostarele,
- pest management in sensitive areas like schools, workplaces, kindergartens, public spaces, lakes, canals, riversides and geriatric care centres,
– tehnična oprema za uporabo biocidnih proizvodov in njihov pregled.
- technical equipment for biocidal product application and its inspection.
Člen 75 – odstavek 1 – točka j b (novo)
Article 75 – paragraph 1 – point j b (new)
(jb) zagotavljanje pomoči državam članicam in usklajevanje med njimi, da bi preprečili vzporedno oceno vlog, povezanih z istim ali podobnim biocidnim proizvodom iz člena 28(4) in 42(5).
(j b ) providing assistance to and coordinating between Member States in order to avoid the parallel assessment of applications relating to the same or similar biocidal products referred to in Articles 28(4) and 42(5).
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:
Komisija na podlagi načel iz odstavka 3 v skladu s členom 82 sprejme delegirane akte , v katerih določi:
The Commission shall adopt, on the basis of the principles set out in paragraph 3, delegated acts pursuant to Article 82 specifying:
(a) pristojbine, ki se plačujejo Agenciji, vključno z letno pristojbino;
(a) the fees payable to the Agency, including an annual fee;
(a) pristojbine, ki se plačujejo Agenciji, vključno z letno pristojbino in pristojbino za predložitev ;
(a) the fees payable to the Agency, including an annual and a submission fee;
(b) pravila glede pogojev za nižje pristojbine, oprostitev pristojbin in povračilo za člana Odbora za biocidne proizvode, ki opravlja nalogo poročevalca; in
(b) 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
(c) pogoje plačila.
(c) conditions of payments.
Uporablja se le v zvezi s pristojbinami, ki se plačujejo Agenciji.
It shall apply only with respect to fees paid to the Agency.
Delegirani akti se uporabljajo le v zvezi s pristojbinami, ki se plačujejo Agenciji.
These delegated acts shall apply only with respect to fees paid to the Agency.
Agencija lahko zahteva tudi takse za druge storitve, ki jih zagotavlja.
The Agency may collect charges for other services it provides.
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, ki se plačujejo, se določijo na taki ravni, da prihodki, ki izhajajo iz pristojbin, v kombinaciji z drugimi viri prihodkov agencije in pristojnih organov na podlagi te uredbe zadostujejo za kritje stroškov opravljenih storitev.
The fees payable 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 and competent authorities’ revenue pursuant to this Regulation, is sufficient to cover the cost of the services delivered.
Pristojbine, ki se plačujejo, objavi Agencija.
The fees payable shall be published by the Agency.
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.
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.
Komisija lahko na podlagi načel iz odstavka 3 izda smernice za usklajenost strukture pristojbin.
Based on the principles set out in paragraph 3, the Commission may issue guidance concerning a harmonised structure of fees.
Komisija na podlagi načel iz odstavka 3 izda smernice za usklajenost strukture pristojbin.
Based on the principles set out in paragraph 3, the Commission shall issue guidance concerning a harmonised structure of fees.
Države članice lahko zaračunajo letne pristojbine v zvezi z biocidnimi proizvodi, ki so dostopni na trgih.
Member States may levy annual fees with respect to biocidal products made available on their markets.
Države članice lahko zahtevajo tudi takse za druge storitve, ki jih zagotavljajo.
Member States may collect charges for other services they provide.
Države članice določijo in objavijo zneske pristojbin, ki se plačujejo njihovim pristojnim organom.
Member States shall set and publish the amount of fees payable to their competent authorities.
Tako v izvedbeni uredbi iz odstavka 1 kot tudi v pravilih držav članic glede pristojbin se upoštevajo naslednja načela:
Both the implementing Regulation referred to in paragraph 1 and Member States' own rules concerning fees shall respect the following principles:
Tako v delegiranih aktih iz odstavka 1 kot tudi v pravilih držav članic glede pristojbin se upoštevajo naslednja načela:
Both the delegated acts referred to in paragraph 1 and Member States' own rules concerning fees shall respect the following principles:
(a) 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;
(a) 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;
(b) pristojbina se delno povrne, kadar vlagatelj zahtevanih informacij ne predloži v določenem roku;
(b) partial reimbursement of the fee if the applicant fails to submit the information requested within the specified time limit;
(c) ustrezno se upoštevajo posebne potrebe MSP ;
(c) the specific needs of SMEs shall be taken into account, as appropriate;
(c) ob upoštevanju sistema za plačilo pristojbin se ustrezno upoštevajo posebne potrebe malih in srednjih podjetij ; to nikakor ne vpliva na odgovornost ustreznega pristojnega organa, da opravi natančno oceno v skladu z določbami te uredbe;
(c) the specific needs of small and medium sized enterprises shall be taken into account, with respect to a fee payment system, as appropriate; 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;
(d) pri strukturi in znesku pristojbin se upošteva, ali so bile informacije predložene skupaj ali ločeno;
(d) the structure and amount of fees shall take into account whether information has been submitted jointly or separately;
(e) v ustrezno utemeljenih okoliščinah in kadar to odobri Agencija ali pristojni organ, se lahko plačilo pristojbine v celoti ali delno oprosti in
(e) 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
(f) izključno pri pravilih držav članic se roki za plačilo pristojbin pristojnim organom določijo ob upoštevanju rokov postopkov iz te uredbe.
(f) as regards Member States' rules only, the deadlines for the payment of fees to competent authorities shall be fixed taking due account of the deadlines of the procedures provided for in this Regulation.
(f) roki za plačilo pristojbin se določijo ob upoštevanju rokov postopkov iz te uredbe.
(f) the deadlines for the payment of fees shall be fixed taking due account of the deadlines of the procedures provided for in this Regulation.
Člen 88 – odstavek 1 – pododstavek 3
Article 88 – paragraph 1 – subparagraph 3
Da bi omogočili nemoten prehod z Direktive 98/8/ES na to uredbo, Komisija v času trajanja delovnega programa sprejme bodisi izvedbene uredbe, s katerimi določi, da je aktivna snov odobrena in pod kakšnimi pogoji, bodisi izvedbene sklepe, ki potrjujejo, da aktivna snov ni odobrena, v primerih, ko zahteve iz člena 4(1) ali, kadar je ustrezno, člena 5(2) niso izpolnjene ali kadar potrebne informacije in podatki niso bili predloženi v predpisanem roku.
In order to facilitate a smooth transition from Directive 98/8/EC to this Regulation, during the work programme the Commission shall adopt either implementing regulations providing that an active substance is approved, and under which conditions, or, in cases where the requirements of Article 4(1) or, where applicable, 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, implementing decisions stating that an active substance is not approved.
V uredbah o odobritvi aktivne snovi se navede datum odobritve.
Regulations approving an active substance shall specify the date of approval.
Komisija z delegiranimi akti v skladu s členom 82 sprejme odločiteve o vključitvi aktivne snovi v Prilogo -I, vključno s pogoji za vključitev, datumi vključitve in iztekom vključitve, ali o nevključitvi aktivne snovi v Prilogo -I.
The Commission shall adopt , by means of delegated acts in accordance with Article 82, decisions on the inclusion of an active substance in Annex -I , including the conditions of the inclusion, the dates of inclusion and of expiry of inclusion, or on the non-inclusion of the active substance in Annex - I .
V primerih, ko zahteve iz člena 4(1) ali, kadar je ustrezno, člena 5(2) niso izpolnjene ali kadar potrebne informacije in podatki niso bili predloženi v predpisanem roku , aktivna snov ni vključena v Prilogo -I .
In cases where the requirements of Article 4(1) or, where applicable, 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, the active substance shall not be included in Annex -I .
Nov pristop, predlagan v besedilu Sveta, na podlagi katerega bi bile snovi predmet ločenih odobritev na podlagi izvedbenih aktov, je premalo transparenten.
The new proposed approach in the Council text - by which they would be subject to separate authorisations by way of implementing acts - lacks transparency.
Poleg tega ni skladen z ustreznimi določbami v členu 27 o vključitvi aktivnih snovi v okviru poenostavljenega postopka, ki bi bile še naprej regulirane na podlagi delegiranih aktov.
In addition, it is inconsistent with the corresponding provisions in Article 27 for the inclusion of active substances under the simplified procedure, which would continue to be regulated by way of delegated acts.
V ta namen vlagatelji, ki želijo zaprositi za dovoljenje ali vzporedno medsebojno priznanje biocidnih proizvodov določene vrste, ki razen obstoječih aktivnih snovi ne vsebujejo nobenih drugih aktivnih snovi, pri pristojnih organih držav članic vložijo vlogo za izdajo dovoljenja ali vzporedno medsebojno priznanje najpozneje na dan odobritve aktivne oziroma aktivnih snovi.
To that effect, those wishing to apply for the authorisation or mutual recognition in parallel of biocidal products of that product-type containing no active substances other than existing active substances shall submit applications for authorisation or mutual recognition in parallel to Member States' competent authorities no later than the date of approval of the active substance(s).
Če biocidni proizvodi vsebujejo več kot eno aktivno snov, se vloge za dovoljenje vložijo najpozneje na dan odobritve zadnje aktivne snovi za to vrsto proizvoda.
In the case of biocidal products containing more than one active substance, applications for authorisation shall be submitted no later than the date of approval of the last active substance for that product-type.
V ta namen vlagatelji, ki želijo zaprositi za dovoljenje ali vzporedno medsebojno priznanje biocidnih proizvodov določene vrste, ki razen obstoječih odobrenih aktivnih snovi ne vsebujejo nobenih drugih aktivnih snovi, pri pristojnih organih držav članic vložijo vlogo za izdajo dovoljenja ali vzporedno medsebojno priznanje najpozneje na dan odobritve aktivne oziroma aktivnih snovi.
To that effect, those wishing to apply for the authorisation or mutual recognition in parallel of biocidal products of that product-type containing no active substances other than approved existing active substances shall submit applications for authorisation or mutual recognition in parallel to Member States' competent authorities no later than the date of approval of the active substance(s).
Člen 88 – odstavek 3 – pododstavek 3 – točka a
Article 88 – paragraph 3 – subparagraph 3 – point a
(a) biocidni proizvod 180 dni po datumu odobritve aktivne oziroma aktivnih snovi ni več dostopen na trgu in
(a) the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of the active substance(s); and
(a) biocidni proizvod po datumu odobritve aktivne oziroma aktivnih snovi ni več dostopen na trgu in
(a) the biocidal product shall no longer be made available on the market with effect from the date of approval of the active substance(s); and
Če ni vloge za dovoljenje ali vzporednega medsebojnega priznavanja, ne bi smelo biti prehodnega obdobja za biocidne proizvode, z izjemo obstoječih zalog.
In the absence of application for authorisation or mutual recognition in parallel, there should be no transitional period for biocidal products with the exception of existing stocks.
Člen 89 – odstavek 2 – pododstavek 1
Article 89 – paragraph 2 – subparagraph 1
Dokumentacijo, predloženo za namene Direktive 98/8/ES, za katero se ocenjevanje ne konča do …** , nadalje ocenjujejo pristojni organi v skladu z določbami Direktive 98/8/ES in, kadar je to primerno, Uredbe (ES) št. 1451/2007.
Dossiers submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by …* 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.
Dokumentacijo, predloženo za namene Direktive 98/8/ES, za katero se ocenjevanje ne konča do …* , nadalje ocenjujejo pristojni organi v skladu z določbami te uredbe in, kadar je to primerno, Uredbe (ES) št. 1451/2007.
Dossiers submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by …* shall be evaluated by the competent authorities in accordance with the provisions of this Regulation and, where relevant, Regulation (EC) No 1451/2007.
Za zagotovitev gladkega prehoda Komisija najkasneje ...* sprejme delegirani akt v skladu s členom 82 o oceni dokumentacije, predložene v skladu z Direktivo 98/8/ES.
To ensure a smooth transition, the Commission shall , no later than ... *, adopt a delegated act in accordance with Article 82 regarding the evaluation of dossiers submitted in accordance with Directive 98/8/EC.
Ta delegirani akt temelji na naslednjih načelih:
This delegated act shall be based on the following principles:
(1) ocena se izvede na podlagi informacij, zagotovljenih v dokumentaciji, predloženi na podlagi Direktive 98/8/ES;
( 1) the evaluation shall be carried out on the basis of the information provided in the dossier as submitted under Directive 98/8/EC;
(2) kadar se v oceni ugotovijo pomisleki zaradi uporabe določb sedanje uredbe, ki niso bili vključeni v Direktivo 98/8/ES, ima predlagatelj možnost, da zagotovi dodatne informacije;
( 2) where the evaluation identifies concerns arising from the application of provisions of the present Regulation, which were not included in Directive 98/8/EC, the applicant shall be given the opportunity to provide additional information;
(3) stori se vse za preprečitev dodatnih preskusov na vretenčarjih;
( 3) every effort shall be made to avoid additional testing on vertebrate animals;
(4) stori se vse za preprečitev zamud pri programu preverjanja, določenem v Uredbi (ES) št. 1451/2007, do katerih lahko pride zaradi te prehodne ureditve.
( 4) every effort shall be made to avoid causing delays to the review programme laid down in Regulation (EC) No 1451/2007 as a result of these transitional arrangements.
*UL: vstaviti datum - dan začetka uporabe te uredbe.
* OJ: Insert the date - the day of application of this Regulation
Člen 89 a (novo)
Article 89 a (new)
Prehodni ukrepi v zvezi z uporabo dovoljenj biocidnih proizvodov v skladu z Direktivo 98/8/ES
Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC
Dokumentacijo, predloženo za namene Direktive 98/8/ES, za katero se ocenjevanje ne konča do …**, ocenjujejo pristojni organi v skladu s to uredbo.
Dossiers submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by …* shall be evaluated by the competent authorities in accordance with this Regulation.
Komisija za zagotovitev gladkega prehoda najkasneje ...* sprejme delegirani akt v skladu s členom 82 v zvezi z oceno dokumentacije, predložene v skladu z Direktivo 98/8/ES.
To ensure a smooth transition, the Commission shall , no later than ... *, adopt a delegated act in accordance with Article 82 regarding the evaluation of dossiers submitted in accordance with Directive 98/8/EC.
(3) stori se vse za preprečitev dodatnih preskusov na vretenčarjih.
( 3) every effort shall be made to avoid additional testing on vertebrate animals.
*UL: vstaviti datum – dan začetka uporabe te uredbe.
* OJ: Insert the date - the day of application of this Regulation
Člen 91 – odstavek 2
Article 91 – paragraph 2
Ta uredba velja za biocidne proizvode iz odstavka 1 po datumu izteka veljavnosti dovoljenja ali njegovega preklica .
This Regulation shall apply to biocidal products referred to in paragraph 1 from the date of the expiry of the authorisation or its cancellation.
Ta uredba , razen poglavja IV, velja za biocidne proizvode iz odstavka 1 od 1 . januarja 2013.
This Regulation, with the exception of Chapter IV thereof, shall apply to biocidal products referred to in paragraph 1 from 1 January 2013 .
Poglavje IV te uredbe velja za biocidne proizvode iz odstavka 1 po datumu izteka veljavnosti dovoljenja ali njegovega preklica.
Chapter IV of this Regulation shall apply to biocidal products referred to in paragraph 1 from the date of expiry or cancellation of the authorisation.
Člen 91 je novo besedilo Sveta.
Article 91 is new text introduced by the Council.
Sedanje besedilo uredbe ne velja za proizvode, odobrene v skladu z direktivo, vsaj ne pred iztekom veljavnosti ali preklica dovoljenja, odobrenega v skladu z določbami direktive.
Under the current wording, the Regulation does not apply to products authorised under the Directive, at least not before the expiry or the cancellation of the authorisation granted in accordance with the provisions of the Directive.