natgillin/translations-raw huggingface dataset:
V skladu s členom 290 PDEU morajo biti v uredbi natančne določbe o prenosu pooblastil.
Pursuant to Article 290 TFEU , detailed provisions on the delegation of powers have to be set out in the Regulation.
Člen 72 – odstavek 5
Article 72 – paragraph 5
Zaradi uskladitve sistema komitologije z novim sistemom delegiranih aktov v skladu s členom 290 PDEU se pri izvajanju uredbe ne bo uporabljal regulativni postopek s pregledom.
Due to the alignment of the comitology regime to the new system of delegated acts pursuant to Article 290 TFEU, the regulatory procedure with scrutiny will not apply for the implementation of the Regulation.
Komisija lahko priloge prilagodi znanstvenemu in tehničnemu napredku.
The Commission may adapt the Annexes to scientific and technical progress.
In order to take account of technical progress, the Commission shall, by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, adapt the Annexes to scientific and technical progress.
In order to take account of technical progress, the Commission shall , by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, adapt the Annexes to scientific and technical progress.
Predlog spremembe
Amendment 23
Člen 73 – odstavek 2
Article 73 – paragraph 2
Ukrepi, zasnovani za spremembo nebistvenih elementov te uredbe, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 72(4).
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).
Člen 75 a (novo)
Article 75 a (new)
Nacionalne službe za pomoč uporabnikom v državah članicah
National helpdesks in Member States
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 .
Kjer ima na podlagi dokazov država članica utemeljene razloge za mnenje , da biocidni pripravek pomeni resno tveganje za zdravje ljudi ali zdravje živali ali za okolje, čeprav izpolnjuje zahteve te uredbe, lahko sprejme ustrezne začasne ukrepe.
Where, based on new evidence, a Member State has justifiable grounds to consider that a biocidal product, although satisfying the requirements of this Regulation, constitutes a serious risk to human or animal health or to the environment, it may take appropriate provisional measures.
Države članice o tem nemudoma obvestijo Komisijo in druge države članice in navedejo razloge za svojo odločitev na podlagi novih dokazov .
The Member State shall without delay inform the Commission and the other Member States thereof and give reasons for its decision based on the new evidence.
Kadar ima država članica na podlagi novih dokazov utemeljene razloge za domnevo , da biocidni pripravek takoj ali pozneje pomeni resno tveganje za zdravje ljudi , zlasti otrok, ali zdravje živali ali za okolje, še posebej za ranljive skupine ali glede doseganja standardov kakovosti iz Direktive 2000/60/ES, in čeprav izpolnjuje zahteve iz te uredbe, lahko država članica sprejme ustrezne začasne ukrepe.
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 immediate or long-term risk to human health, in particular as regards children, or animal health or to the environment, particularly to vulnerable groups , or to achieving the quality standards of Directive 2000/60/EC , it may take appropriate provisional measures.
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.
Koristna pojasnitev, ki poudari manjšo tolerančno stopnjo za škodljive proizvode v primerjavi z odraslimi, na katerih po predlogu uredbe slonijo merila tolerančne stopnje škodljivosti.
It would seem appropriate to highlight the fact that children are more vulnerable to harmful products than adults, on whom the proposal for a regulation is basing tolerance criteria.
Člen 76 – odstavek 2
Article 76 – paragraph 2
Komisija v skladu s postopkom iz člena 72(3) dovoli začasne ukrepe za časovno obdobje, določeno v sklepu, ali zahteva, da država članica prekliče začasni ukrep.
The Commission shall, in accordance with the procedure referred to in Article 72(3), either authorise the provisional measure for a time period defined in the decision or require the Member State to revoke the provisional measure.
V skladu s členom 193 pred kratkim sprejete pogodbe o EU lahko države članice ohranijo ali uvedejo strožje zaščitne ukrepe za izboljšanje kakovosti okolja in za varstvo zdravja ljudi.
According to Article 193 of the newly adopted EU-Treaty member states can maintain or introduce more stringent protective measures for the improvement of the quality of the environment and the protection of human health.
Člen 77 – odstavek 1 – pododstavek 1
Article 77 – paragraph 1 – subparagraph 1
Komisija nadaljuje z izvajanjem delovnega programa za sistematično preverjanje vseh obstoječih aktivnih snovi, ki ga začne v skladu s členom 16(2) Direktive 98/8/ES in ga izvede 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 and achieve it by 14 May 2014.
Komisija lahko sprejme pravila za izvajanje delovnega programa in za določanje s tem povezanih pravic in obveznosti pristojnih organov in udeležencev v programu.
The Commission may adopt implementing rules to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme .
Ukrepi, določeni za spremembo nebistvenih elementov te uredbe z njeno dopolnitvijo, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 72(4).
Those measures , designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4) .
Za zagotovitev gladkega prehoda lahko Komisija z delegiranimi akti v skladu s členom 71a ter pod pogoji iz členov 71b in 71c sprejme pravila za izvajanje delovnega programa in za določanje s tem povezanih pravic in obveznosti pristojnih organov in udeležencev v programu ter glede na napredek pri izvajanju delovnega programa odločitev, da se delovni program podaljša za določeno obdobje .
In order to ensure a smooth transition, the Commission may adopt , by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, implementing rules to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme , and , depending upon the progress of the work programme, a decision to extend the duration of the work programme for a determined period .
Člen 77 – odstavek 1 – pododstavek 2
Article 77 – paragraph 1 – subparagraph 2
Glede na napredek pri izvajanju delovnega programa lahko Komisija podaljša delovni program za določen čas.
Depending upon the progress of the work programme, the Commission may extend the duration of the work programme for a determined period.
Ta ukrep, zasnovan za spremembo nebistvenih elementov te uredbe, tako da jo dopolni, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 72(4).
That measure, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).
Člen 77 – odstavek 1 – pododstavek 3
Article 77 – paragraph 1 – subparagraph 3
Med delovnim programom se Komisija odloči v skladu s postopkom iz člena 72(4), da se aktivna snov vključi v Prilogo I te uredbe in pod kakšnimi pogoji ali v primerih, ko zahteve iz člena 4 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.
During the work programme, the Commission shall decide pursuant to the procedure laid down in Article 72(4) 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 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.
V odločitvi je naveden datum začetka veljavnosti vključitve v Prilogo I.
The decision shall specify the date on which the inclusion in Annex I becomes effective.
Da se pri delovnem programu doseže napredek, se Komisija z delegiranimi akti v skladu s členom 71 ter pod pogoji iz členov 71b in 71c odloči, da se aktivna snov vključi v Prilogo I te uredbe in pod kakšnimi pogoji ali v primerih, ko zahteve iz člena 4 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.
In order to progress with the work programme, the Commission shall decide , by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, 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 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.
Člen 77 – odstavek 3 – pododstavek 3
Article 77 - paragraph 3 - subparagraph 3
Biocidni pripravki, za katere vloga za dovoljenje za pripravek ni bila vložena v skladu z drugim pododstavkom, se ne dajejo več v promet , in sicer šest mesecev 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 with effect from six months 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 osemnajst mesecev po datumu, ko začne vključitev veljati.
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 eighteen months after the date on which the inclusion 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 šest mesecev po datumu, ko začne vključitev veljati.
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 six months after the date on which the inclusion becomes effective.
Daljša obdobja naj ne bi bila potrebna, saj bi morali uporabniki biocidnih pripravkov nižje v verigi poznati svoje obveznosti in stanje pregleda aktivne snovi.
Longer periods should not be required, as downstream users should know their obligations and the status of the testing of the active substance.
Člen 80 – odstavek 1
Article 80 - paragraph 1
Ta pododstavek ne velja za snovi za razkuževanje pitne vode, ki so bile proizvedene na kraju samem.
This paragraph shall not apply to active substances generated in situ for the purpose of disinfecting drinking water.
Razkuževanje pitne vode je ustrezno urejeno z Direktivo 98/83/ES o pitni vodi in z uredbo REACH.
Disinfection of drinking water is adequately regulated by the European drinking water directive (98/83/EC) and the REACH Regulation.
Člen 81
Article 81
Z odstopanjem od člena 47 se lahko tretirani izdelki in materiali, ki vsebujejo biocidne pripravke, ki niso dovoljeni v Skupnosti ali vsaj v eni državi članici in so bili v prometu dne ...
By way of derogation from Article 47, treated articles and materials that incorporate biocidal products which are not authorised in the Community or in at least one Member State and which were available on the market on ...
[UL: vstavite datum iz prvega pododstavka člena 85] do datuma odločitve o izdaji dovoljenja za te biocidne pripravke še naprej dajejo v promet, če je bila vloga za dovoljenje vložena najpozneje do 1. januarja 2017 .
[OJ: insert the date referred to in the first subparagraph of Article 85] may, until the date of a decision granting authorisation to these biocidal products, continue to be placed on the market if the application for authorisation is submitted at the latest by 1 January 2017 .
Če se dovoljenje za dajanje biocidnih pripravkov v promet zavrne, se tretirani izdelki in snovi, ki vsebujejo takšne biocidne pripravke, prenehajo dajati v promet v šestih mesecih po sprejetju takšne odločitve.
In the case of a refusal to grant an authorisation to place a biocidal product on the market, treated articles and materials that incorporate such biocidal product shall no longer be placed on the market within six months after such decision.
Z odstopanjem od člena 47 se lahko tretirani izdelki in materiali, ki vsebujejo biocidne pripravke, ki niso dovoljeni v Uniji ali vsaj v eni državi članici in so bili v prometu dne ...
By way of derogation from Article 47, treated articles and materials that incorporate biocidal products which are not authorised in the Union or in at least one Member State and which were available on the market on ...
[UL: vstavite datum iz prvega pododstavka člena 85] do datuma odločitve o izdaji dovoljenja za te biocidne pripravke še naprej dajejo v promet, če je bila vloga za dovoljenje vložena najpozneje do 1. januarja 2015 .
[OJ: insert the date referred to in the first subparagraph of Article 85] may, until the date of a decision granting authorisation to these biocidal products, continue to be placed on the market if the application for authorisation is submitted at the latest by 1 January 2015 .
Predlog spremembe
Amendment 24
Člen 81 – odstavek 1 a (novo)
Article 81 - paragraph 1 a (new)
Odstranitev, skladiščenje in uporaba obstoječih zalog biocidnih pripravkov, ki jih pristojni organi ali Komisija niso dovolili za zadevno uporabo, so dovoljeni do poteka dvanajstih mesecev od datuma odločitve iz prvega pododstavka člena 80(2) ali dvanajst mesecev od datuma iz drugega pododstavka člena 80(2), kar je pozneje.
Disposal, storage and use of existing stocks of biocidal products which are not authorised for the relevant use by the competent authority or the Commission are allowed until twelve months after the date of the decision referred to in the first subparagraph of Article 80 (2) or twelve months after the date referred to in the second subparagraph of Article 80(2) , whichever is the later.
Dodatek tega odstavka iz člena 80 zagotavlja skladne ukrepe za nove pripravke, ki bodo spadali v področje uporabe uredbe o biocidnih pripravkih.
The addition of this paragraph taken from Article 80 ensures consistent measures for the new products which will fall under the scope of the Biocidal Products Regulation.
Člen 83
Article 83
Prehodni ukrepi v zvezi z dostopom do dokumentacije o aktivni snovi
Transitional measures concerning access to the active substance dossier
Od 1. januarja 2014 ima oseba, ki je odgovorna za dajanje v promet biocidnih pripravkov, ki vsebujejo eno ali več obstoječih aktivnih snovi , v lasti dokumentacijo ali izjavo o dostopu do takšne dokumentacije ali do vsakega dela te dokumentacije, s čimer so izpolnjene zahteve iz Priloge II za vsako od teh aktivnih snovi , razen če so potekla vsa zadevna obdobja varovanja iz člena 49 .
As of 1 January 2014 , the person responsible for the placing on the market of a biocidal product containing one or more existing active substances shall own a dossier or have a letter of access to a dossier , or to each component of the dossier, satisfying the requirements set out in Annex II for each of these active substances unless all relevant protection periods referred to in Article 49 have expired .
Proizvajalci obstoječih aktivnih snovi, ki so na trgu za uporabo v biocidnih pripravkih, do 1. januarja 2015 predložijo Agenciji dokumentacijo ali izjavo o dostopu do dokumentacije , ki izpolnjuje zahteve iz Priloge II za vsako od teh aktivnih snovi.
By 1 January 2015 , manufacturers of existing active substances which are on the market for use in biocidal products shall submit to the Agency a dossier or a letter of access to a dossier which complies with the requirements of Annex II for each of these active substances.
Za namene pododstavka 1 velja člen 52(3) za vse podatke iz dokumentacije.
For the purpose of subparagraph 1, Article 52(3) shall apply to all data included in the dossier.
Vlagatelj, ki prosi za dovoljenje za biocidni pripravek z aktivno snovjo, za katero je bila predložena izjava o dostopu v skladu s pododstavkom 1, lahko to izjavo uporablja za namene člena 18(1).
The applicant for the authorisation of a biocidal product containing an active substance for which a letter of access has been submitted in accordance with subparagraph 1 shall be allowed to use th at letter of access for the purposes of Article 18(1).
Agencija javno objavi seznam proizvajalcev, ki so predložili dokumentacijo ali izjavo o dostopu do nje v skladu s pododstavkom 1.
The Agency shall make publicly available the list of manufacturers which have submitted a dossier or a letter of access to a dossier in accordance with paragraph 1.
Biocidni pripravki, za katere oseba, ki je odgovorna za dajanje v promet, ne izpolnjuje zahtev prvega pododstavka , se prenehajo dajati v promet.
Biocidal products for which the person responsible for the placing on the market does not fulfil the requirement of the first subparagraph shall no longer be placed on the market.
Biocidni pripravki, ki vsebujejo obstoječe aktivne snovi, za katere ni bila predložena dokumentacija ali izjava o dostopu do nje v skladu s podostavkom 1 , se po 1. januarju 2015 ne smejo dajati v promet.
Biocidal products containing existing active substances for which a dossier or a letter of access to a dossier has not been submitted in accordance with paragraph 1 shall not be placed on the market after 1 January 2015 .
Odstranitev, skladiščenje in uporaba obstoječih zalog biocidnih pripravkov, ki ne izpolnjujejo zahteve iz prvega odstavka , je dovoljena do 1. januarja 2015 .
Disposal, storage and use of existing stocks of biocidal products which do not fulfil the requirement of the first subparagraph is allowed until 1 January 2015 .
Odstranitev, skladiščenje in uporaba obstoječih zalog biocidnih pripravkov , za katere ni bila posredovana dokumentacija ali izjava o dostopu do nje v skladu s pododstavkom 1 , je dovoljena do 1. januarja 2016 .
Disposal, storage and use of existing stocks of biocidal products for which a dossier or a letter of access to a dossier has not been submitted in accordance with paragraph 1 is allowed until 1 January 2016 .
Priloga I – uvodni del (novo)
Annex I - introductory paragraph (new)
Snovi, navedene v Prilogi I, ne zajemajo nanomaterialov, razen če so posebej navedeni.
Substances listed in Annex I do not cover nanomaterials, except where specifically mentioned.
Nanomateriali se uporabljajo zaradi svojih različnih ali boljših lastnosti v primerjavi s snovmi v običajni obliki.
Nanomaterials are used due to their different or enhanced properties as compared to substances in bulk form.
Zaradi majhnosti in posledičnega povečanja relativne površine lahko pomenijo novo tveganje.
Due to their miniscule size and the resulting increase of relative surface area, they may pose new risks.
Zato jih je treba posebej oceniti.
Thus, they require an assessment in their own right.
Vključitev snovi v Prilogo I ne sme veljati za nanomateriale, razen če so posebej navedeni, sicer bi odprli možnost koristoljubnim težnjam.
An inclusion of a substance in Annex I must not count for nanomaterials, unless specifically mentioned, otherwise nanomaterials would be given a "free-ride".
Predlagano besedilo je vzeto iz uredbe o kozmetičnih izdelkih, v kateri je za nekatere snovi tudi uporabljen pristop pozitivnega seznama (preambula k prilogam II do VI).
The wording proposed here is taken from the cosmetics regulation, which also has a positive list approach for certain substances (preamble to Annexes II to VI).
Priloga I – difenakum – 9. vrstica - 8. kolona
Annex I -difenacoum - 9 th row - 8 th column
Zaradi dejstva, da je aktivna snov zaradi svojih lastnosti lahko obstojna, se kopiči v organizmih in je strupena ali je dolgotrajno obstojna in se močno kopiči v organizmih, se aktivna snov obravnava kot možna snov za zamenjavo v skladu s členom 9.
In view of the fact that the active substance characteristics render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the active substance shall be considered a candidate for substitution in accordance with Article 9.
Ker aktivna snov zaradi svojih lastnosti izpolnjuje merila za uvrstitev kot strupena za razmnoževanje kategorije 1A in je lahko obstojna, se kopiči v organizmih in je strupena ali je dolgotrajno obstojna in se močno kopiči v organizmih, se obravnava kot možna snov za zamenjavo v skladu s členom 9.
In view of the fact that the active substance characteristics meet the criteria for classification as toxic to reproduction category 1A and render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the active substance shall be considered a candidate for substitution in accordance with Article 9.
Dovoljenja se izdajo pod naslednjimi pogoji:
Authorisations are subject to the following conditions:
Glede na ugotovljena tveganja za vodni prostor, močno strupenost za ptice in sesalce, tveganje za zastrupitev dojenčkov, problem nastanka odpornosti ter bolečino in dolgotrajno trpljenje se dovoljenja izdajo pod naslednjimi pogoji:
In view of the risks identified for the aquatic compartments, the fact that the active substance is very toxic to birds and mammals, the risks for infant poisoning, the problem of resistance formation and the pain and prolonged suffering it causes in target animals, authorisations are subject to the following condition:
Dokazana je resna nevarnost za javno zdravje, ki je ni mogoče nadzorovati z nobenim drugim sredstvom.
A serious danger to public health is proven that cannot be controlled by any other means.
Sprejmejo se naslednji ukrepi za zmanjšanje tveganja:
The following risk - mitigation measures shall be taken:
(1) Nazivna koncentracija aktivne snovi v pripravkih ne presega 75 mg/kg, dovoljenje pa se izda samo za pripravke, ki se lahko takoj uporabijo.
(1) The nominal concentration of the active substance in the products shall not exceed 75 mg/kg and only ready-for-use products shall be authorised.
(1) Nazivna koncentracija aktivne snovi v pripravkih ne presega 75 mg/kg, dovoljenje pa se izda samo za pripravke, ki se lahko takoj uporabijo .
(1) The nominal concentration of the active substance in the products shall not exceed 75 mg/kg and only ready-for-use products shall be authorised.