natgillin/translations-raw huggingface dataset:
Za določitev enotnih pogojev za uporabo točke (a) odstavka 2 Komisija z izvedbenimi akti določi, v katerih okoliščinah bi bila zaradi izpostavljenosti, povezane s predlagano uporabo, utemeljena prilagoditev zahtev glede podatkov iz točk (a) in (b) odstavka 1.
In order to establish uniform conditions for the application of point (a) of paragraph 2, the Commission shall , by means of implementing acts, specify in which circumstances the exposure associated with the proposed uses would justify adapting the data requirements of points (a) and (b) of paragraph 1.
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 81(3).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 81(3).
Komisijo se pooblasti za sprejetje delegiranih aktov v skladu s členom 82 s prilagoditvijo meril, ki opredeljujejo, kaj je ustrezna utemeljitev za prilagoditev podatkov, ki se zahtevajo v skladu z odstavkom 1 pod pogoji iz točke (a) odstavka 2 .
The Commission shall be empowered to adopt delegated acts in accordance with Article 82 adapting the criteria for what constitutes adequate justification to adapt the data required under paragraph 1 on the grounds referred to in point (a) of paragraph 2 .
To je določba splošne uporabe, namenjena za dopolnitev osnovnega akta, zato bi morala biti predmet delegiranih, ne pa izvedbenih aktov.
As this is a provision of general application designed to supplement the basic act, it should therefore be subject to delegated rather than implementing acts.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 79(1), Agencija sprejme vlogo in o tem ustrezno obvesti vlagatelja in ocenjevalni pristojni organ, pri čemer navede točni datum sprejetja vloge in njeno enkratno identifikacijsko kodo.
Upon receipt of the fees payable under Article 79(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the exact date of the acceptance of the application and its unique identification code.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 79(1) in (2) , Agencija sprejme vlogo in o tem ustrezno obvesti vlagatelja in ocenjevalni pristojni organ, pri čemer navede točni datum sprejetja vloge in njeno enkratno identifikacijsko kodo.
Upon receipt of the fees payable under Article 79(1) and (2) , the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the exact date of the acceptance of the application and its unique identification code.
V besedilu Sveta ni upoštevano, da je bil člen 79 spremenjen, tako da so pristojbine razdeljene na pristojbine za agencijo in pristojbine za ocenjevalni organ.
The Council text fails to take account of the fact that Article 79 has been modified so as to subdivide the fees into agency fees and evaluating authority fees.
Namen tega predloga spremembe je zagotoviti doslednejše in skladnejše besedilo.
The aim of this amendment is to ensure a more consistent and coherent text.
Potem ko je agencija sprejela vlogo, ocenjevalni pristojni organ čim prej obvesti vlagatelja o pristojbinah, ki se plačujejo na podlagi člena 79(2), in zavrne vlogo, če vlagatelj ne plača pristojbin v 30 dneh.
The evaluating competent authority shall, as soon as possible after the Agency has accepted an application, inform the applicant of the fees payable under Article 79(2) and shall reject the application if the applicant fails to pay the fees within 30 days.
Besedilo Sveta ne upošteva sprememb člena 79, na podlagi katerih so sedaj pristojbine razdeljene na pristojbine za agencijo in pristojbine za ocenjevalni organ.
The Council text does not take account of the changes to Article 79 where fees are now split between fees for the Agency and fees for the evaluating authority.
Zaradi skladnosti ni razloga, da bi bil rok plačila pristojbin ocenjevalnemu pristojnemu organu krajši ali daljši od roka plačila pristojbin agenciji.
And for the sake of consistency, there does not appear to be any reason for the deadline for the payment of fees to the evaluating competent authority to be shorter or longer than the deadline for payment of fees to the Agency.
Namen je izboljšati skladnost (tako znotraj besedila kot tudi z drugimi deli zakonodaje) in pojasniti besedilo.
It is intended to improve consistency (both within the text and with other pieces of legislation) to clarify the text.
Člen 7 – odstavek 4 – pododstavek 3
Article 7 – paragraph 4 – subparagraph 3
Če vlagatelj zahtevanih informacij ne predloži v roku, ocenjevalni pristojni organ vlogo zavrne in o tem ustrezno obvesti vlagatelja in Agencijo.
The evaluating competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant and the Agency accordingly.
V takšnih primerih se del pristojbine, plačane v skladu s členom 79 , povrne.
In such cases, part of the fee paid in accordance with Article 79 shall be reimbursed.
V takšnih primerih se del pristojbin, plačanih v skladu s členom 79(1) in (2), povrne.
In such cases, part of the fees paid in accordance with Article 79(1) and (2) shall be reimbursed.
Če se izkaže, da so za izvedbo ocene potrebne dodatne informacije, ocenjevalni pristojni organ od vlagatelja zahteva, da v določenem roku predloži take informacije, in ustrezno obvesti Agencijo.
Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit, and shall inform the Agency accordingly.
Kot je določeno v drugem pododstavku člena 6(2), lahko ocenjevalni pristojni organ po potrebi od vlagatelja zahteva, da zagotovi dovolj podatkov, na podlagi katerih je mogoče ugotoviti, ali aktivna snov izpolnjuje merila iz člena 5(1) ali 10(1).
As specified in the second subparagraph of Article 6(2), the evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to permit a determination of whether an active substance meets the criteria referred to in Article 5(1) or 10(1).
Obdobje 365 dni iz odstavka 1 tega člena se prekine od dneva izdaje zahtevka do dneva prejema informacij.
The 365-day period referred to in paragraph 1 of this Article shall be suspended from the date of issue of the request until the date the information is received.
Prekinitev skupno ne presega 180 dni, razen če je to upravičeno zaradi narave zahtevanih podatkov ali izrednih okoliščin.
The suspension shall not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.
Kadar te dodatne informacije vključujejo preskuse na živalih, strokovnjaki iz agencije ali ocenjevalni pristojni organi svetujejo vlagatelju glede ustreznih drugih metod in preskusnih strategij, da se nadomestijo, zmanjšajo ali izboljšajo preskusi na vretenčarjih.
Where such additional information includes animal testing, the applicant shall be advised by experts from the Agency or the evaluating competent authorities regarding suitable alternative methods and testing strategies to replace, reduce or refine the use of vertebrate animals.
Kadar ocenjevalni pristojni organ meni, da obstajajo pomisleki glede kumulativnih učinkov uporabe biocidnih proizvodov, ki vsebujejo isto aktivno snov, svoje pomisleke dokumentira skladno z zahtevami ustreznih delov oddelka II.3 Priloge XV k Uredbi (ES) št. 1907/2006 in jih vključi med svoje ugotovitve.
Where the evaluating competent authority considers that there are concerns with regard to the cumulative effects from the use of biocidal products containing the same active substance, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 and include this as part of its conclusions.
Kadar ocenjevalni pristojni organ meni, da obstajajo pomisleki glede kumulativnih učinkov uporabe biocidnih proizvodov, ki vsebujejo isto aktivno snov, ali različne snovi s podobnimi ali enakimi učinki na iste končne točke, bodisi z enakim bodisi različnim mehanizmom delovanja, svoje pomisleke dokumentira skladno z zahtevami ustreznih delov oddelka II.3 Priloge XV k Uredbi (ES) št. 1907/2006 in jih vključi med svoje ugotovitve.
Where the evaluating competent authority considers that there are concerns with regard to the cumulative effects from the use of biocidal products containing the same active substance, or different substances with similar or common effects on the same endpoints, whether by the same or different mechanism of action, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 and include this as part of its conclusions.
(Ponovna vložitev predloga spremembe 57 iz prve obravnave.)
(Reinstatement of amendment 57 from first reading.)
Kumulativni učinki, ki jih je treba upoštevati, ne bi smeli biti omejeni na uporabo proizvodov z isto aktivno snovjo, temveč bi morali zajemati tudi proizvode z drugimi snovmi, ki imajo podobne učinke.
Cumulative effects to be considered should not be limited to the use of products with the same active substance, but also include products with other substances with similar effects.
Komisija ob prejemu mnenja Agencije iz člena 8(4) bodisi:
The Commission shall, on receipt of the opinion of the Agency referred to in Article 8(4), either:
Komisija ob prejemu mnenja Agencije iz člena 8(4) z delegiranimi akti v skladu s členom 82 sprejme odločitev o vključitvi aktivne snovi v Prilogo -I, vključno s pogoji za vključitev, datumom vključitve in iztekom vključitve, ali o nevključitvi aktivne snovi v Prilogo I.
The Commission shall, on receipt of the opinion of the Agency referred to in Article 8(4), adopt, by means of delegated acts in accordance with Article 82, a decision on the inclusion of the 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.
(a) sprejme izvedbeno uredbo o odobritvi aktivne snovi in o pogojih za to odobritev, vključno z datumi odobritve in poteka odobritve; ali
(a) adopt an implementing Regulation providing that an active substance is approved, and under which conditions, including the dates of approval and of expiry of the approval; or
(b) 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, sprejme izvedbeni sklep, da se aktivna snov ne odobri.
(b) i n cases where the requirements of Article 4(1) or, where applicable, Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, adopt an implementing decision that an active substance is not approved.
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 81(3).
T hose implementing acts shall be adopted in accordance with the examination procedure referred to in Article 81(3).
Predlogu spremembe 17 poročevalke so dodani nekateri elementi.
Amendment of new text by Council, adding certain elements to am 17 by the rapporteur.
Odobritev aktivnih snovi bi morala potekati z delegiranimi akti, da se spoštujejo pravice Parlamenta do nadzora.
The approval of active substances should be done by delegated act to ensure the control rights of Parliament.
Dodati je treba pogoje in ustrezne datume za vključitev in njen iztek.
It should include the conditions and relevant dates of inclusion and expiry of inclusion.
Obstajati bi morala tudi samostojna odločitev, če snov ni vključena v Prilogo -I, da bi imeli zabeležene vse odločitve.
There should also be a decision in its own right if a substance is not included in Annex -I to have a record of all decisions.
Odobrene aktivne snovi se vključijo na seznam odobrenih aktivnih snovi Unije.
Approved active substances shall be included in a Union list of authorised active substances.
Komisija seznam posodablja in ga v elektronski obliki da na razpolago javnosti.
The Commission shall keep the list up to date and make it electronically available to the public.
Če bo sprejet, bo treba vsa sklicevanja na člen 9(2), omembe seznama, sestavljenega v skladu s členom 9(2) in seznama iz člena 9(2), zamenjati z omembo Priloge -I.)
If adopted, any reference to Article 9(2) is to be deleted, and any reference to "the list drawn up in accordance with Article 9(2)" or the "list referred to in Article 9(2)" is to be replaced by a reference to "Annex -I". )
Glej predloge sprememb, povezane s členom 4(1) in členom 9(1).
See linked amendments to Article 4(1) and Article 9(1).
Zaradi pravne varnosti in preglednosti bi se morale aktivne snovi ohraniti v prilogi k uredbi in ne v ločenem dokumentu, ki ni del uredbe.
For reasons of legal certainty and transparency, active substances should continue to be included in an Annex to the Regulation itself and not in a separate document which is not part of the Regulation.
To zagotavlja tudi stalno posodabljanje in spreminjanje uredbe (samodejno ob vključitvi aktivne snovi), zato je ločen seznam odveč.
This would also ensure that the Regulation is continually updated and amended (automatically upon the inclusion of an active substance), and would thus render a separate list unnecessary.
Člen 10 – odstavek 1 – točka a a (novo)
Article 10 – paragraph 1 – point a a (new)
(aa) izpolnjuje merila, na podlagi katerih je v skladu z Uredbo (ES) št. 1272/2008 razvrščena kot povzročitelj preobčutljivosti dihal;
(a a) it meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as a respiratory sensitiser;
(Ponovna vložitev predloga spremembe 65 iz prve obravnave.)
(Reinstatement of amendment 65 of first reading.)
Aktivne snovi, ki so povzročitelji preobčutljivosti dihal, bi tudi morale biti možne snovi za zamenjavo.
Active substances that are respiratory sensitisers should also be candidates for substitution.
Člen 10 – odstavek 1 – točka d
Article 10 – paragraph 1 – point d
(d) obstajajo razlogi za zaskrbljenost, povezani z naravo kritičnih učinkov, ki v kombinaciji z vzorci uporabe povzročijo uporabo, ki lahko tudi ob zelo restriktivnih ukrepih za obvladovanje tveganja še vedno zbuja zaskrbljenost, kot denimo visoka raven tveganja za podtalnico;
(d) there are reasons for concern linked to the nature of the critical effects which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures;
(d) obstajajo razlogi za zaskrbljenost, povezani z naravo kritičnih učinkov, predvsem razvojnih nevrotoksičnih ali imunotoksičnih učinkov, ki v kombinaciji z vzorci uporabe povzročijo uporabo, ki lahko tudi ob zelo restriktivnih ukrepih za obvladovanje tveganja še vedno zbuja zaskrbljenost, kot denimo visoka raven tveganja za podtalnico;
(d) there are reasons for concern linked to the nature of the critical effects , in particular developmental neurotoxic or immunotoxic effects which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures;
Ponovna vložitev besedila iz prve obravnave.
Reinstatement of first reading.
Če v odločitvi o podaljšanju odobritve aktivne snovi ni drugače določeno, velja podaljšanje za petnajst let za vse vrste proizvodov, na katere se odobritev nanaša.
Unless otherwise specified in the decision to renew the approval of an active substance, the renewal shall be for fifteen years for all product-types to which the approval applies.
Če v odločitvi o podaljšanju odobritve aktivne snovi ni strožje določeno, velja podaljšanje za deset let za vse vrste proizvodov, na katere se odobritev nanaša.
Unless more strictly specified in the decision to renew the approval of an active substance, the renewal shall be for ten years for all product-types to which the approval applies.
(Ponovna vložitev predloga spremembe 71 iz prve obravnave.)
(Reinstatement of amendment 71 from first reading.)
Besedilo Sveta je dvoumno, saj bi dovolilo tudi podaljšanje za obdobje, ki presega 15 let.
The Council wording is ambiguous, it would also allow for a renewal for a period exceeding 15 years.
Znanost se hitro razvija, ad hoc pregledi pa potekajo zelo redko.
Science is developing fast, and ad hoc reviews occur only very rarely.
Zaradi tega podaljšanje ne bi smelo presegati 10 let, da bi zagotovili primerno oceno najkasneje vsakih deset let.
As such, a renewal should not exceed 10 years to ensure a proper reassessment every ten years at the latest.
Novo besedilo upošteva besedilo člena 79, po katerem je treba eno pristojbino plačati agenciji, ločeno pristojbino pa ocenjevalnemu pristojnemu organu.
The new text takes into account the wording of Article 79 in which there is now one fee to be paid to the Agency and a separate fee for the evaluating competent authority.
Zaradi skladnosti ni razloga, da bi bil rok plačila pristojbin ocenjevalnemu pristojnemu organu krajši ali daljši od roka plačila pristojbin agenciji.
For consistency, there does not appear to be any reason for the deadline for the payment of fees to the evaluating competent authority to be shorter or longer than the deadline for payment of fees to the Agency.
Namen je izboljšati skladnost (tako znotraj besedila kot tudi z drugimi deli zakonodaje) in pojasniti besedilo.
It is intended to improve consistency (both within the text and with other pieces of legislation), and to clarify the text.
Komisija ob prejemu mnenja Agencije sprejme :
The Commission shall, on receipt of the opinion of the Agency, adopt :
Komisija ob prejemu mnenja Agencije z delegiranimi akti v skladu s členom 82 sprejme odločitev o obnovitvi vključitve aktivne snovi v Prilogo -I za eno ali več vrst proizvodov ali o neobnovitvi vključitve.
The Commission shall, on receipt of the opinion of the Agency, adopt , by means of delegated acts in accordance with Article 82, a decision on the renewal of the inclusion of the active substance in Annex -I for one or more product-types, or of the non-renewal of inclusion.
Če se vključitev obnovi, se v odločitvi navedejo pogoji obnovitve ter datum obnovitve in datum izteka vključitve.
In the event that the inclusion is renewed, the decision shall state the conditions of renewal and the dates of renewal and of expiry of inclusion.
(a) izvedbeno uredbo o podaljšanju odobritve aktivne snovi za eno ali več vrst proizvodov in o pogojih za to podaljšanje; ali
(a) an implementing Regulation providing that the approval of an active substance is renewed for one or more product-types, and under which conditions; or
(b) izvedbeni sklep, da se odobritev aktivne snovi ne obnovi.
(b) an implementing decision that the approval of an active substance is not renewed.
Uporablja se člen 9(2).
Article 9(2) shall apply.
Predlogu spremembe 20 poročevalke so dodani nekateri elementi.
Amendment of new text by Council, adding certain elements to am 20 by the rapporteur.
Obnovitev aktivnih snovi bi morala potekati z delegiranimi akti, da se spoštujejo pravice Parlamenta do nadzora.
The renewal of active substances should be done by delegated act to ensure the control rights of Parliament.
Obstajati bi morala tudi samostojna odločitev, če vključitev snovi v Prilogo -I ni obnovljena, da bi imeli zabeležene vse odločitve.
There should also be a decision in its own right if the inclusion of a substance in Annex -I is not renewed to have a record of all decisions.
Če Komisija odloči, da odobritve aktivne snovi za eno ali več vrst proizvodov ne obnovi, lahko odobri prehodno obdobje za odstranitev, dostopnost na trgu in uporabo obstoječih zalog zadevnih vrst biocidnih proizvodov, ki vsebujejo to aktivno snov.
Where the Commission decides not to renew the approval of an active substance for one or more product-types it may grant a period of grace for the disposal, making available on the market and use of existing stocks of biocidal products of the product-type(s) concerned containing that active substance.
Če Komisija odloči, da vključitve aktivne snovi v Prilogo -I za eno ali več vrst proizvodov ne obnovi ali jo spremeni , države članice ali, v primeru dovoljenja Unije, Komisija, prekličejo ali, kjer je potrebno, spremenijo dovoljenja biocidnih proizvodov, ki vsebujejo to aktivno snov.
Where the Commission decides not to renew or to amend the inclusion of an active substance in Annex -I for one or more product-types , the Member States or, in the case of a Union authorisation, the Commission shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance.
V skladu s tem se uporablja člen 51.
Article 51 shall apply accordingly.
Prehodno obdobje ne sme presegati 180 dni za dostopnost na trgu in dodatnih največ 180 dni za odstranitev in uporabo obstoječih zalog zadevnih vrst biocidnih proizvodov, ki vsebujejo to aktivno snov.
The period of grace shall not exceed 180 days for making available on the market and an additional maximum of 180 days for disposal and use of existing stocks of biocidal products of the product-type(s) concerned containing that active substance.
V skladu s členom 14(4) predloga Sveta lahko Komisija zavrne obnovitev odobritve, obnovi odobritev ali jo obnovi v spremenjeni obliki pod novimi pogoji.
According to Article 14 (4) of the Council proposal, the Commission can refuse the renewal of an approval, renew the approval or renew it in amended form under new conditions.
Ob uporabi tretje možnosti se prvotna odobritev spremeni, zato je pomembno, da se to omeni na tem mestu.
In this third case, the original approval is amended, so it is important to refer to this possibility here.
Sedanja različica besedila ne omenja, kaj se zgodi v primeru negativne odločitve Komisije glede obnovitve.
The current version of the text does not specify what happens after the Commission has taken a non-favourable decision on renewal.
Zato je pomembno, da se opišejo koraki med odločitvijo o neobnovitvi ali omejitvi in prehodnim obdobjem.
Therefore, it is important to describe the steps between the decision of non-renewal or restriction and the period of grace.
Komisija lahko kadarkoli pregleda odobritev aktivne snovi za eno ali več vrst proizvodov, če se pojavijo resni znaki, da pogoji iz člena 4(1) ali po potrebi člena 5(2) niso več izpolnjeni .
The Commission may review the approval of an active substance for one or more product-types at any time where there are serious indications that the conditions laid down in Article 4(1) or, where relevant, Article 5(2) are no longer met.
Komisija lahko na zahtevo države članice pregleda tudi odobritev aktivne snovi za eno ali več vrst proizvodov, če se pojavijo resni znaki, da uporaba aktivne snovi v biocidnem proizvodu ali tretiranem izdelku povzroča resno zaskrbljenost glede varnosti tega biocidnega proizvoda ali tretiranega izdelka.
The Commission may also review the approval of an active substance for one or more product-types at the request of a Member State if there are indications that the use of the active substance in biocidal products or treated articles raises serious concerns about the safety of such biocidal products or treated articles.
Komisija lahko kadarkoli pregleda odobritev aktivne snovi za eno ali več vrst proizvodov, če se pojavijo pomenljivi znaki, da kateri od pogojev iz člena 4(1) ali po potrebi člena 5(2) ni več izpolnjen .
The Commission may review the approval of an active substance for one or more product-types at any time where there are significant indications that any of the conditions laid down in Article 4(1) or, where relevant, Article 5(2) are no longer met.