natgillin/translations-raw huggingface dataset:
Na podlagi poročila o pregledu, drugih dejavnikov, povezanih z obravnavano zadevo, in previdnostnega načela, kadar so pogoji iz člena 7(1) Uredbe (ES) št. 178/2002 relevantni, se uredba sprejme v skladu z regulativnim postopkom iz člena 79(3) , če:
On the basis of the review report, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that:
Na podlagi poročila o pregledu, drugih dejavnikov, povezanih z obravnavano zadevo, in previdnostnega načela, kadar so pogoji iz člena 7(1) Uredbe (ES) št. 178/2002 relevantni, se uredba z ustrezno utemeljitvijo sprejme v skladu z regulativnim postopkom s pregledom iz člena 79(4) , če:
On the basis of the review report, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation with due justification shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7 9 ( 4 ) , providing that:
(a) je aktivna snov odobrena pod pogoji in omejitvami iz člena 6, kjer je to primerno;
(a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate;
(a) je aktivna snov odobrena pod pogoji in omejitvami iz člena 6, kadar je to primerno, in vključena v Prilogo IIa ;
(a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate, and included in Annex IIa;
Preglednost postopka je treba povečati, zato je treba ohraniti vključitev odobrenih snovi v prilogo uredbe.
Therefore the inclusion of approved substances in an Annex of the Regulation should be maintained.
Ponovna vložitev predloga spremembe 88 iz prve obravnave.
Reinstating of first reading Amendment 88.
Odobrene aktivne snovi se vključijo v uredbo iz člena 78(3), ki vsebuje seznam že odobrenih aktivnih snovi.
Approved active substances shall be included in the Regulation referred to in Article 78(3) containing the list of active substances already approved .
Komisija vodi seznam odobrenih aktivnih snovi , ki je javnosti na voljo v elektronski obliki .
The Commission shall maintain a list of approved active substances electronically available to the public.
Komisija vodi posodobljen seznam odobrenih aktivnih snovi v Prilogi IIa in ta seznam objavi na internetu .
The Commission shall maintain an updated list of approved active substances in Annex IIa and publish this list on the Internet .
Ponovna vložitev predloga spremembe 89 s prve obravnave.
Reinstating first reading Amendment 89.
Obnovitev odobritve velja največ petnajst let.
The renewal of the approval shall be for a period not exceeding fifteen years.
Odobritev aktivne snovi iz člena 4(7) se lahko obnovi za obdobje največ petih let.
The renewal of approval of active substances covered by Article 4(7) shall be for a period not exceeding five years.
Odobritev aktivne snovi iz člena 4(7) se lahko obnovi za obdobje največ štirih let.
The renewal of approval of active substances covered by Article 4(7) shall be for a period not exceeding four years.
V predlaganem besedilu podaljšanje registracije, o čemer odločajo države članice, sledi obnovitvi odobritve aktivne snovi (člen 43(5)).
In the proposed text the renewal of the authorisation by the Member State follows the renewal of the active substance (Article 43(5)).
To je v nasprotju s previdnostnim načelom, načelom, da se odločitve sprejema ob upoštevanju najnovejših znanstvenih dognanj in tehničnih dosežkov, kot je opredeljeno v členu 4(1) predlaganega besedila, in načelom, da je treba ohranjati visok standard varstva (uvodna izjava 9).
This is contrary to the precautionary principle and to the principle that decisions are made in the light of current scientific and technical knowledge, as is laid down in Article 4(1) of the proposed text, and the principle that a high standard of protection must be ensured (recital 9).
Ponovna vložitev predloga spremembe 90 s prve obravnave.
Reinstating first reading Amendment 90.
Zahtevek iz člena 14 proizvajalec aktivne snovi predloži zadevni državi članici, pri čemer pošlje en izvod drugim državam članicam, Komisiji in Agenciji, in sicer najpozneje tri leta pred iztekom prve odobritve.
The application provided for in Article 14 shall be submitted by a producer of the active substance to the Member State concerned , with a copy to the other Member States, the Commission and the Authority, no later than three years before the expiry of the first approval.
Ponovna vložitev predloga spremembe 91 s prve obravnave.
Reinstating first reading Amendment 91.
Člen 18 – točka b
Article 18 – point (b)
(b) potrebne podatke, ki jih je treba predložiti;
(b) the necessary data to be submitted;
(b) potrebne podatke, ki jih je treba predložiti , vključno z ukrepi za omejitev preskusov na živalih, zlasti z uporabo metod, pri katerih se ne uporabljajo živali, in inteligentnih strategij preskušanja ;
(b) the necessary data to be submitted including measures to minimise animal testing, in particular the use of non-animal test methods and intelligent testing strategies ;
Da bi preskuse na živalih za namene te uredbe čim bolj omejili, je treba v program vključiti tudi ukrepe, ki bodo to omogočili.
In order to ensure that animal testing for the purposes of this Regulation is kept to an absolute minimum, measures to facilitate this should also be included in the programme.
Ponovna vložitev predloga spremembe 92 s prve obravnave.
Reinstating first reading Amendment 92.
Člen 20 – odstavek 1 – uvodni del
Article 20 – paragraph 1 – introductory part
Uredba se sprejme v skladu z regulativnim postopkom iz člena 79(3) , če:
A Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that:
Uredba se z ustrezno utemeljitvijo sprejme v skladu z regulativnim postopkom s pregledom iz člena 79(4) , če:
A Regulation with due justification shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79 ( 4 ) , providing that:
Ponovna vložitev predloga spremembe 94 s prve obravnave.
Reinstating first reading Amendment 94.
Kadar razlogi za zavrnitev obnovitve odobritve to dovoljujejo , se z uredbo iz odstavka 1 zagotovi prehodno obdobje , ki ni daljše od enega leta, za dajanje v promet, ter dodatno prehodno obdobje, ki ni daljše od enega leta, za odstranjevanje, shranjevanje in uporabo obstoječih zalog zadevnih fitofarmacevtskih sredstev.
Where the reasons for not renewing the approval permit it , the Regulation referred to in paragraph 1 shall provide for a grace period not exceeding one year for the placing on the market and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned.
Kadar razlogi za zavrnitev obnovitve odobritve ne zadevajo varovanja zdravja in okolja , se z uredbo iz odstavka 1 zagotovi prehodno obdobje za porabo zalog zadevnih fitofarmacevtskih sredstev , ki ni daljše od enega leta .
Where the reasons for not renewing the approval do not concern the protection of health or the environment , the Regulation referred to in paragraph 1 shall provide for a grace period not exceeding one year for using up stocks of the plant protection products concerned .
V primeru preklica odobritve ali če odobritev ni obnovljena zaradi neposredne zaskrbljenosti glede zdravja ljudi ali živali ali okolja, se zadevno fitofarmacevtsko sredstvo nemudoma umakne s trga.
In the case of a withdrawal of the approval or if the approval is not renewed because of the immediate concerns for human health or animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately.
V primeru preklica odobritve ali če odobritev ni obnovljena zaradi zaskrbljenosti glede zdravja ljudi ali živali ali okolja, se zadevno fitofarmacevtsko sredstvo nemudoma umakne s trga.
In the case of a withdrawal of the approval or if the approval is not renewed because of concerns for human health or animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately.
Prehodno obdobje enega leta se lahko odobri samo v primeru, če razlogi za neobnovitev odobritve niso povezani z varovanjem zdravja in okolja.
A grace period of one year should only be granted if the reasons for not renewing the approval do not concern the protection of health or the environment.
Kadar odobritev fitofarmacevtskega sredstva ni bila obnovljena zaradi zaskrbljenosti glede zdravja ljudi ali živali ali okolja, je treba to sredstvo nemudoma umakniti s trga.
An immediate withdrawal shall occur whenever the plant protection product was not renewed because of the concerns for human health or animal health or the environment.
Ponovna vložitev predloga spremembe 95 s prve obravnave.
Reinstating first reading Amendment 95.
Člen 21 – odstavek 1 – pododstavek 1
Article 21 – paragraph 1 – subparagraph 1
Upošteva lahko zahtevo države članice za pregled odobritve aktivne snovi.
It may take into account the request of a Member State to review the approval of an active substance.
Komisija lahko kadar koli pregleda odobritev aktivne snovi in ustrezno upošteva zahteve za pregled s strani držav članic, Evropskega parlamenta in drugih zainteresiranih strani, na podlagi najnovejših znanstvenih dognanj in tehničnih dosežkov ter spremljanja podatkov .
The Commission may review the approval of an active substance at any time and shall give due consideration to requests for review from a Member State, the European Parliament or other stakeholders, based on current scientific and technical knowledge and monitoring data .
Predlog spremembe si tudi prizadeva zagotoviti, da bi odločitve upoštevale najnovejša znanstvena dognanja in tehnične dosežke, kot je določeno v členu 4(1) predlaganega besedila, in načelo, da je treba zagotoviti visok standard varstva, kot je določeno v uvodni izjavi 9.
The amendment also seeks to ensure that decisions take into account current scientific and technical knowledge, as it is laid down in Article 4(1) of the proposed text and the principle that a high standard of protection must be ensured, as stipulated in recital 9.
Člen 21 – odstavek 1 – pododstavek 2 a (novo)
Article 21 – paragraph 1 – subparagraph 2 a (new)
Komisija pregleda odobritev aktivne snovi, če obstajajo znamenja, da cilji, določeni v skladu s členom 4(1)(a)(iv) in (b)(i) ter členom 7(2) in (3) Direktive 2000/60/ES, morda ne bodo doseženi.
The Commission shall review the approval of an active substance where there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may be compromised.
Ponovna vložitev predloga spremembe 98 s prve obravnave.
Reinstating first reading Amendment 98.
Člen 21 – odstavek 3 – pododstavek 1
Article 21 – paragraph 3 – subparagraph 1
Če Komisija ugotovi, da snov ne izpolnjuje več meril za odobritev iz člena 4 ali da niso bile predložene zahtevane dodatne informacije v skladu s členom 6(f), se v skladu z regulativnim postopkom iz člena 79(3) sprejme Uredba o prenehanju ali spremembi odobritve.
Where the Commission concludes that the approval criteria provided for in Article 4 are no longer satisfied, or the further information required in accordance with point (f) of Article 6 has not been provided, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure referred to in Article 79(3).
Če Komisija ugotovi, da snov ne izpolnjuje več meril za odobritev iz člena 4 ali da niso bile predložene zahtevane dodatne informacije v skladu s členom 6(f), se v skladu z regulativnim postopkom s pregledom iz člena 79(4) sprejme Uredba o prenehanju ali spremembi odobritve.
Where the Commission concludes that the approval criteria provided for in Article 4 are no longer satisfied, or the further information required in accordance with point (f) of Article 6 has not been provided, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7 9 ( 4 ).
Ponovna vložitev predloga spremembe 99 s prve obravnave.
Reinstating first reading Amendment 99.
Člen 21 – odstavek 3 a (novo)
Article 21 – paragraph 3 a (new)
Če Komisija ugotovi, da cilji zmanjšanja onesnaževanja s prednostnimi snovmi iz člena 4(1)(a)(iv) in (b)(i) ter člena 7(2) in (3) Direktive 2000/60/ES ne bodo izpolnjeni, se v skladu z regulativnim postopkom s pregledom iz člena 79(4) te uredbe sprejme uredba o prenehanju ali spremembi odobritve.
Where the Commission concludes that the objectives of reducing pollution from priority substances established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC cannot be met, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4) of this Regulation.
Ponovna vložitev predloga spremembe 100 iz prve obravnave.
Reinstatement of first reading Amendment 100.
Člen 22 – odstavek 1 – pododstavek 1 a (novo)
Article 22 – paragraph 1 – subparagraph 1 a (new)
To odstopanje se ne uporablja za aktivne snovi, razvrščene v skladu z Direktivo 67/548/EGS kot:
This derogation shall not apply to any active substance classified in accordance with Directive 67/548/EEC as:
– kemikalije, ki povzročajo preobčutljivost,
– sensitising chemicals ,
Komisija najkasneje ...* pregleda in po potrebi določi merila za obravnavo aktivnih snovi kot snovi z majhnim tveganjem ter po potrebi poda predloge.
No later than ...*, the Commission shall review and if necessary specify the criteria for treating an active substance as a low risk substance and, if appropriate, submit proposals.
* eno leto po začetku veljavnosti te uredbe
* One year after the entry into force of this Regulation.
Da bi spodbudili raziskave manj škodljivih snovi in izdelkov, je treba podjetjem zagotoviti jasnost in pravno varnost glede tega, kaj točno pomenijo aktivne snovi z majhnim tveganjem.
To encourage research for less harmful substances and products, it is important to provide businesses with clarity and legal certainty on what exactly is meant by a low risk profile.
Tu našteta merila so deloma prevzeta iz direktive o biocidnih pripravkih, 98/8/ES.
The criteria listed here are partly taken from the biocides directive, 98/8/EC.
Po teh merilih bi se od 25 do 30 % aktivnih snovi obravnavalo kot aktivne snovi z majhnim tveganjem.
With these criteria 25% to 30% of active substances would be considered as low risk.
Ponovna vložitev predloga spremembe 102 s prve obravnave.
Reinstating first reading Amendment 102.
Ne glede na določbe člena 5 se aktivne snovi, ki temeljijo na bioloških sredstvih in ki izpolnjujejo merila iz člena 4, odobri za največ 15 let, kadar se pričakuje, da bodo fitofarmacevtska sredstva, ki takšna biološka sredstva vsebujejo, predstavljala le majhno tveganje za zdravje ljudi in živali ter za okolje, kot je določeno v členu 47(1).
Notwithstanding Article 5, active substances based on biological control agents which comply with the crite ria set out in Article 4 shall be given approval for a period not exceeding 15 years where plant protection products containing such biological control agents are expected to present only a low risk to human and animal health and the environment as defined in Article 47 (1).
Ponovna vložitev predloga spremembe 103 s prve obravnave.
Reinstating first reading Amendment 103.
Člen 22 – odstavek 2
Article 22 –paragraph 2
Uporabljajo se členi 4 in 6 do 21 ter oddelek 5 Priloge II.
Articles 4 and 6 to 21 and Section 5 of Annex II shall apply.
Snovi z majhnim tveganjem se navedejo ločeno v uredbi iz člena 13(4) .
Low-risk active substances shall be listed separately in the Regulation referred to in Article 13(4).
Aktivne snovi z majhnim tveganjem se navedejo ločeno v Prilogi IIa .
Low-risk active substances shall be listed separately in Annex IIa.
Ta predlog spremembe je v skladu s predlogom spremembe k členu 13(2), ki določa, da je treba aktivne snovi odobriti po regulativnem postopku s pregledom.
Amendment in line with the amendment to Article 13(2) that establishes RPS for the approval of active substances.
Predlog spremembe k novemu besedilu, ki ga je predlagal Svet.
Amendment of a new sentence introduced by Council.
Člen 23 – odstavek 1 – pododstavek 2 a (novo)
Article 23 – paragraph 1 – subparagraph 2 a (new)
Za namen te uredbe se aktivna snov, ki izpolnjuje merila za „živila“, kot so opredeljena v členu 2 Uredbe (ES) št. 178/2002, šteje za osnovno snov.
For the purpose of this Regulation, an active substance which fulfils the criteria of a 'foodstuff' as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as a basic substance.
Snovi, ki v skladu s členom 2 Uredbe (ES) št. 178/2002 štejejo k živilom, že po svoji opredelitvi niso strupene.
Substances which are foodstuffs according to Article 2 of Regulation (EC) No 178/2002 are per definition as foodstuffs not toxic.
Take snovi, kot je na primer sončnično olje, se trenutno uporabljajo v ekološkem kmetijstvu.
Such substances, e.g. sun flower oils, are currently used in organic farming.
Ponovna vložitev predloga spremembe 274 s prve obravnave.
Reinstating first reading Amendment 274.
Člen 23 – odstavek 2
Article 23 – paragraph 2
Z odstopanjem od člena 4 se osnovna snov odobri, če ustrezna ocenjevanja, izvedena v skladu z ostalo zakonodajo Skupnosti, ki ureja uporabo te snovi za druge namene kot za fitofarmacevtska sredstva, dokažejo, da snov nima takojšnjega škodljivega vpliva ali zapoznelega škodljivega vpliva na zdravje ljudi ali živali in nobenega nesprejemljivega vpliva na okolje.
By way of derogation from Article 4, a basic substance shall be approved where any relevant evaluations, carried out in accordance with other Community legislation regulating the use of that substance for purposes other than for a plant protection product, show that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment.
Osnovna snov se odobri v skladu s členom 4 , če ustrezna ocenjevanja, izvedena v skladu z ostalo zakonodajo Skupnosti, ki ureja uporabo te snovi za druge namene kot za fitofarmacevtska sredstva, dokažejo, da snov nima takojšnjega škodljivega vpliva ali zapoznelega škodljivega vpliva na zdravje ljudi ali živali in nobenega nesprejemljivega vpliva na okolje , če so izpolnjene vse zahteve za podatke, ki veljajo za aktivne snovi v fitofarmacevtskih sredstvih, in če se uporabljajo isti postopki odločanja .
A basic substance shall be approved in accordance with Article 4 and where any relevant evaluations, carried out in accordance with other Community legislation regulating the use of that substance for purposes other than for a plant protection product, show that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment, provided that each point of the data requirements for active substances contained in plant protection products is given and the same decision-making procedures apply .
Ponovna vložitev predloga spremembe 105 s prve obravnave.
Reinstating first reading Amendment 105.
Člen 23 – odstavek 5
Article 23 –paragraph 5
Uporabljata se člena 6 in 13.
Articles 6 and 13 shall apply.
Snovi z majhnim tveganjem se navedejo ločeno v uredbi iz člena 13(4) .
Basic substances shall be listed separately in the Regulation referred to in Article 13(4).
Snovi z majhnim tveganjem se navedejo ločeno v Prilogi IIa .
Basic substances shall be listed separately in Annex IIa.
Aktivna snov, ki izpolnjuje merila iz člena 4, se odobri kot možna snov za zamenjavo, če izpolnjuje eno ali več dodatnih meril, določenih v točki 4 Priloge II.
An active substance complying with the criteria provided for in Article 4 shall be approved as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II.
Z odstopanjem od člena 14(2) se odobritev lahko obnovi enkrat ali večkrat, za obdobje, ki ne presega deset let.
By way of derogation from Article 14(2), the approval may be renewed once or more for a period not exceeding ten years .
Z odstopanjem od člena 14(2) se odobritev lahko obnovi enkrat ali večkrat, za obdobje, ki ne presega pet let.
By way of derogation from Article 14(2), the approval may be renewed once or more for a period not exceeding five years .
Obdobje za odobritev možnih snovi za zamenjavo ne bi smelo biti enako splošnemu obdobju za odobritev.
The approval time of candidates for substitution should not be the same as the general approval period.
Za zagotovitev redne primerjalne ocene sredstev, ki vsebujejo takšne snovi, bi bilo treba obdobje za odobritev omejiti na 5 let (z možnostjo podaljšanja).
To ensure regular comparative assessment of products containing such substances, the approval period should be limited to 5 years (renewable).
Namen tega predloga spremembe je tudi pojasniti, da Parlament nikoli ni sprejel stališča, ki bi pomenilo avtomatično postopno odpravo možnih snovi za zamenjavo.
This amendment should also clarify that Parliament never adopted a position that would have meant an automatic phase out of candidates for substitution.
Postopna odprava se zahteva le, če je izpolnjena vrsta pogojev (gl. člen 50).
Such phase out is only required when a series of conditions is fulfilled (see Art. 50).
Delna ponovna vložitev predloga spremembe 106 iz prve obravnave.
Partially reinstating first reading Amendment 106.
Nadomesti predlog spremembe 92 poročevalca.
Replaces amendment 92 by the rapporteur.
Člen 24 – odstavek 2
Article 24 –paragraph 2
Brez poseganja v odstavek 1 se uporabljajo členi 4 do 21.
Without prejudice to paragraph 1, Articles 4 to 21 shall apply.
Možne snovi za zamenjavo se navedejo ločeno v uredbi iz člena 13(4) .
Candidates for substitution shall be listed separately in the Regulation referred to in Article 13(4).
Možne snovi za zamenjavo se navedejo ločeno v Prilogi IIa .
Candidates for substitution shall be listed separately in Annex IIa.
Člen 25 – odstavek 1 a (novo)
Article 25 – paragraph 1 a (new)
Ponovna vložitev predloga spremembe 107 s prve obravnave.
Reinstating first reading Amendment 107.
Do … se v skladu z regulativnim postopkom s pregledom iz člena 79(4) sprejme uredba o vzpostavitvi delovnega programa za postopen pregled sinergistov in varoval, ki so na trgu ob začetku veljavnosti te uredbe.
By …*, a Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4) establishing a work programme for the gradual review of synergists and safeners on the market when that Regulation enters into force.
Uredba vključuje postopke obveščanja, vrednotenja, ocenjevanja in odločanja.
The Regulation shall include notification, evaluation, assessment and decision-making procedures.
Od zainteresiranih strani zahteva, da Komisiji, Agenciji in državam članicam v določenem roku predložijo vse potrebne podatke.
It shall require interested parties to submit all the necessary data to the Member States, the Commission and the Authority within a specified time period.
Do … * se v skladu s postopkom iz člena 251 Pogodbe sprejme uredba o vzpostavitvi delovnega programa za postopen pregled sinergistov in varoval, ki so na trgu ob začetku veljavnosti te uredbe.
By ...*, a Regulation shall be adopted in accordance with the procedure referred to in Article 251 of the Treaty establishing a work programme for the gradual review of synergists and safeners on the market when that Regulation enters into force.
Uredba vključuje določitev zahtev po podatkih, vključno z ukrepi za omejitev preskusov na živalih, ter za postopke obveščanja, vrednotenja, ocenjevanja in odločanja.
The Regulation shall include the establishment of data requirements, including measures to minimise animal testing , notification, evaluation, assessment and decision-making procedures.