natgillin/translations-raw huggingface dataset:
Zahtevek iz člena 14 proizvajalec aktivne snovi predloži 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 a Member State, 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.
Zahtevek iz člena 14 proizvajalec aktivne snovi vloži 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.
(b) navedbo pravil/pravila o podatkih, ki jih je treba predložiti;
(b) the necessary data to be submitted;
(b) navedbo pravil/pravila o podatkih, ki jih je treba predložiti , vključno z ukrepi za omejitev poskusov na živalih, zlasti z uporabo metod, pri katerih se ne uporabljajo živali, in inteligentnih strategij poskusov ;
(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 poskuse 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.
Uredba, sprejeta v skladu s postopkom iz člena 76(3) , opredeljuje določbe, potrebne za izvedbo postopka podaljšanja in pregleda, vključno z izvedbo delovnega programa iz člena 18, kadar je to primerno.
A Regulation, adopted in accordance with the procedure referred to in Article 76(3), shall set out the provisions necessary for the implementation of the renewal and review procedure, including, where relevant, the implementation of a programme of work, as provided for in Article 18.
Uredba, sprejeta v skladu z regulativnim postopkom s pregledom iz člena 76(3a) , opredeljuje določbe, potrebne za izvedbo postopka podaljšanja in pregleda, vključno z izvedbo delovnega programa iz člena 18, kadar je to primerno.
A Regulation, adopted in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a), shall set out the provisions necessary for the implementation of the renewal and review procedure, including, where relevant, the implementation of a programme of work, as provided for in Article 18.
Uredba se sprejme v skladu s postopkom iz člena 76(3) , če:
A Regulation shall be adopted in accordance with the procedure referred to in Article 76(3) , providing that:
Uredba se z ustrezno utemeljitvijo sprejme v skladu z regulativnim postopkom s pregledom iz člena 76(3a) , če:
A Regulation with due justification shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a) , providing that:
Kadar razlogi za zavrnitev obnovitve odobritve to dovoljujejo , Uredba iz odstavka 1 zagotovi podaljšan rok za porabo zalog zadevnih fitofarmacevtskih sredstev, ki ne bo posegal v običajno obdobje uporabe fitofarmacevtskega sredstva .
Where the reasons for not renewing the approval permit it , the Regulation referred to in paragraph 1 shall provide for a grace period for using up stocks of the plant protection products concerned, which will be such that it does not interfere with the normal period of use of the plant protection product .
Kadar razlogi za zavrnitev obnovitve odobritve ne zadevajo varovanja zdravja in okolja , uredba iz odstavka 1 zagotovi podaljšan rok za porabo zalog zadevnih fitofarmacevtskih sredstev, ki ne traja dlje kot eno leto .
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 for using up stocks of the plant protection products concerned, which shall be not longer than one year.
Proizvajalci po tem obdobju zagotovijo varno odstranitev preostalih zalog.
Past this period, producers shall ensure the removal and safe disposal of the remaining stocks .
Rok za porabo zalog fitofarmacevtskih sredstev ne bi smel biti daljši kot eno leto.
Not more than one year should be granted for using up stocks of the plant protection product.
Proizvajalci bi morali po tem obdobju zagotoviti varno odstranitev svojih sredstev.
Beyond this period, producers should ensure the safe removal and disposal of their product.
Ob prepovedi ali preklicu odobritve iz zdravstvenih ali okoljskih razlogov, je treba fitofarmacevtsko sredstvo nemudoma odstraniti.
In the event of a ban or the withdrawal of the approval on health or environmental grounds, the plant protection product concerned shall be disposed of immediately.
Komisija lahko kadar koli pregleda odobritev aktivne snovi.
The Commission may review the approval of an active substance at any time.
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 and other stakeholders, based on current scientific and technical knowledge and monitoring data .
Za zagotovitev preglednosti postopka in za uskladitev predloga s previdnostnim načelom.
To ensure transparency in the process and align the proposal to the precautionary principle.
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 21.
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 21.
Člen 21, odstavek 1, pododstavka 2 a in 2 b (novo)
Article 21, paragraph 1, subparagraphs 2 a and 2 b (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.
Pregleda se odobritev za deset aktivnih snovi, katerih vsebnost v letnih poročilih o spremljanju ostankov pesticidov, ki jih objavlja Komisija, najpogosteje presega mejne vrednosti ostankov.
The approval shall be reviewed for the ten active substances most often found to be present above the maximum residue level (MRL) in the annual monitoring reports on pesticide residues published by the Commission.
Odobritev se prekliče za snov, ki je večkrat na tem seznamu.
Where the same substance is found repeatedly on that list, the approval shall be withdrawn.
Čeprav lahko Komisija kadarkoli sproži pregled za neko snov, je treba posebej zapisati, da lahko zahtevo za pregled vložijo tudi druge institucije in interesne skupine.
While the Commission can launch a review for a given substance at any time, it should be made clear that requests for review can also be initiated by other institutions or stakeholders.
Če cilji Direktive 2000/60/ES niso izpolnjeni, je treba omogočiti, da se odobritev snovi znova pretehta.
It is essential that, in cases of non-compliance with the objectives of Directive 2000/60/EC, it is possible to reconsider the approval of the substance.
Ta mehanizem neposrednih povratnih informacij pri izvajanju Direktive 2000/60/ES in te uredbe bo dodatno spodbudil proizvajalce, da resno pretehtajo svojo odgovornost, kar zadeva nadzor nad izdelki.
Moreover, this direct feedback mechanism between Directive 2000/60/EC and this Regulation will also provide an extra incentive for producers to seriously consider their responsibilities in terms of product stewardship.
Člen 21, odstavek 3, pododstavek 1
Article 21, paragraph 3, subparagraph 1
Če Komisija ugotovi, da snov ne izpolnjuje več meril iz člena 4 ali da niso bile predložene zahtevane dodatne informacije v skladu s členom 6(f), se v skladu s postopkom iz člena 76(3) sprejme Uredba o prenehanju ali spremembi odobritve.
Where the Commission concludes that the criteria referred to 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 procedure referred to in Article 76(3).
Če Komisija ugotovi, da snov ne izpolnjuje več meril 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 76(3a) sprejme uredba o prenehanju ali spremembi odobritve.
Where the Commission concludes that the criteria referred to 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 76(3a).
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 76(3a) 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 76(3a) of this Regulation.
Če cilji Direktive 2000/60/ES niso izpolnjeni, je treba omogočiti, da se odobritev snovi znova pretehta.
It is essential that in case of non-compliance with the objectives of Directive 2000/60/EC for a substance, it is possible to reconsider the approval of the substance.
Postopek mora biti usklajen z določbami novega sklepa o komitologiji.
The procedure should be in line with the provisions of the new decision on comitology.
Z odstopanjem od člena 5 se aktivna snov, ki izpolnjuje merila iz člena 4, odobri za največ 15 let, kadar se lahko pričakuje, da bo fitofarmacevtsko sredstvo, ki to snov vsebuje, povzročilo le majhno tveganje za zdravje ljudi in živali ter za okolje, kot je določeno v členu 46(1).
By way of derogation from Article 5, an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years, where it may be expected that plant protection products containing that substance will pose only a low risk to human and animal health and the environment, as provided for in Article 46(1).
Z odstopanjem od člena 5 se aktivna snov, ki izpolnjuje merila iz člena 4, odobri za največ 15 let, kadar ne bo škodljivo vplivala na zdravje ljudi in živali ter na okolje, kot je določeno v členu 46(1).
By way of derogation from Article 5, an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years, where it will have no adverse effect on human and animal health and the environment, as provided for in Article 46(1).
Za pojasnitev, da lahko med aktivne snovi z majhnim tveganjem štejemo aktivne snovi, ki nimajo škodljivih vplivov na ljudi, živali ali okolje.
To clarify that active substances that have no adverse effect on humans, animals or the environment can be considered as low-risk.
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 št. 67/548/ES kot:
This derogation shall not apply to any active substance classified in accordance with Directive 67/548/EEC as:
– reproduktivno toksične,
– toxic to reproduction,
ali snovi, ki se razvrstijo kot:
or to substances that are qualified as:
– obstojne z razpolovno dobo, ki traja več kot 60 dni,
– persistent with a half-life of more than 60 days,
– snovi, ki povzročajo endokrine motnje, s seznama EU snovi, za katere se sumi, da povzročajo endokrine motnje,
– endocrine disrupters appearing on the EU list of suspected endocrine disrupters,
– bioakumulativne in biološko težko razgradljive.
– bioaccumulative and non-readily degradable.
Komisija najkasneje ...* pregleda in po potrebi določi merila za obravnavo aktivnih snovi kot snovi z majhnim tveganjem ter predloži predloge, če je to primerno.
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 direktive
* One year after the entry into force of this Regulation.
Določiti je treba jasna in objektivna merila za razvrstitev snovi kot snovi z nižjim profilom tveganja, ki v predlogu niso opredeljena.
There is a need to lay down clear and objective criteria to define which substances can claim to have a low risk profile.
V predlogu to ni opredeljeno.
There is no definition for this in the proposal.
Zaradi spodbujanja raziskav manj škodljivih snovi in izdelkov, je treba zagotoviti, da si bodo podjetja na jasnem in bo obstajala pravna gotovost 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/EGS.
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.
Člen 22, odstavek 1 a (novo)
Article 22, paragraph 1 a (new)
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 vsebuje, predstavljala le majhno tveganje za zdravje ljudi in živali ter za okolje, kot je določeno v členu 46(1).
Notwithstanding Article 5, active substances based on biological control agents which comply with the crite ria of 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 46(1).
Uporaba fitofarmacevtskih sredstev, ki temeljijo na bioloških sredstvih, veliko obeta na področju varovanja zdravja ljudi in živali ter okolja in bi jo bilo treba v celoti podpreti.
The use of plant protection substances based on biological control agents offers excellent prospects for the protection of human and animal health and of the environment and should be fully supported.
Takšna biološka sredstva so zaradi nizke stopnje tveganja potencialno zelo koristna.
In view of their low-risk nature, such biological control agents have great potential benefits.
Ker imajo fitofarmacevtska sredstva, ki temeljijo na bioloških sredstvih, pogosto sorazmerno majhno območje uporabe, je za spodbujanje raziskav in razvoja, ki bodo zadostovali za takšna fitofarmacevtska sredstva, potrebno 15 letno obdobje.
Since plant protection based on biological control agents often has a relatively small area of application, a 15-year approval period is necessary in order to promote sufficient research and development for such plant protection products.
Člen 23, odstavek 1, uvodni del
Article 23, paragraph 1, introductory part
Osnovne snovi se odobrijo v skladu z odstavki od 2 do 6.
Basic substances shall be approved in accordance with paragraphs 2 to 6.
Z odstopanjem od člena 5 se odobritev izda za nedoločen čas.
By way of derogation from Article 5, the approval shall be for an unlimited period of time .
V teh odstavkih je osnovna snov aktivna snov, ki
For the purpose of those paragraphs, a basic substance is an active substance which
V teh odstavkih je osnovna snov aktivna snov, ki
For the purpose of those paragraphs, a basic substance is an active substance which:
Uredba ne sme omogočati registracije osnovnih snovi za nedoločen čas.
No unlimited authorisations shall be foreseen in the Regulation for basic substances.
Te snovi je treba redno pregledovati ob upoštevanju najnovejših znanstvenih dognanj, podobno kot aktivne snovi.
Similarly to active substances, they should be subject to a regular review in line with the latest scientific information and data.
Z odstopanjem od člena 5 se osnovna snov odobri, če ustrezna vrednotenja, 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 5 , 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 as 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 vrednotenja, 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 as 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 .
Postopek ocenjevanja tveganja bi moral biti obvezen tudi za osnovne snovi.
The risk assessment procedure shall be mandatory also for basic substances.
Člen 24, odstavek 1, pododstavek 1
Article 24, paragraph 1, subparagraph 1
Z odstopanjem od člena 5 in člena 14(2) se aktivna snov, ki izpolnjuje merila iz člena 4, odobri za največ sedem let, če so ostale že odobrene aktivne snovi veliko manj strupene za potrošnike ali delavce ali predstavljajo veliko manjše tveganje za okolje.
By way of derogation from Article 5 and Article 14(2), an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding seven years , where other already approved active substances are significantly less toxic for consumers or operators or present significantly fewer risks for the environment.
Pri ocenjevanju se upoštevajo merila iz točke 4 Priloge II.
The assessment shall take account of the criteria laid down in point 4 of Annex II.
Z odstopanjem od člena 5 in člena 14(2) se aktivna snov, ki izpolnjuje merila iz člena 4, enkrat odobri za največ pet let, če so ostale že odobrene aktivne snovi oziroma alternativne kmetijske metode ali prakse veliko manj strupeni za potrošnike ali delavce ali predstavljajo veliko manjše tveganje za okolje.
By way of derogation from Article 5 and Article 14(2), an active substance complying with the criteria provided for in Article 4 shall be approved once for a period not exceeding five years , where other already approved active substances or alternative agricultural methods or practices are significantly less toxic for consumers or operators or present significantly fewer risks for the environment.
Glede na to, da se druge snovi odobrijo za 10 let in da je alternativna snov že na voljo na trgu, je 7 letno obdobje registracije za snovi, ki jih je treba nadomestiti, občutno predolgo.
Bearing in mind that the approval for other substances is 10 years and substitution is by existing alternatives in the market, 7 years for the authorisation of candidates for substitution is clearly excessive.
Na Švedskem so na primer uvedli program za nadomestitev pesticidov, kjer je bil rok za iskanje alternativ pet let.
In Sweden, for example, a programme for the substitution of pesticides was completed giving 5 years as a deadline for finding alternatives.
Nadomestitev fitofarmacevtskih sredstev z nekemičnimi alternativami bi morala biti prva prednostna naloga.
Substituting plant protection products by non-chemical alternatives should be the first priority.
Pri odobritvi varovala ali sinergista velja, da so zahteve iz odstavka 1 izpolnjene, če se skladnost s členom 4 ugotavlja ob upoštevanju ene ali več reprezentativnih rab najmanj enega fitofarmacevtskega sredstva za vsako aktivno snov, s katero je varovalo ali sinergist kombiniran.
For approval of a safener or synergist, paragraph 1 shall be deemed to be satisfied where compliance with Article 4 has been established with respect to one or more representative uses of at least one plant protection product for every different active substance the safener or synergist is combined with.
Varovala in sinergiste se oceni v povezavi z različnimi aktivnimi snovmi, s katerimi so kombinirani.
Safeners and synergists shall be assessed in relation to different active substances with which they are combined.
V 5 letih po začetku veljavnosti te uredbe se sprejme uredba v skladu s postopkom iz člena 76(3) o vzpostavitvi delovnega programa za postopen pregled sinergistov in varoval, ki so na trgu ob začetku veljavnosti te uredbe.
Within 5 years of the entry into force of this Regulation, a Regulation shall be adopted in accordance with the procedure referred to in Article 76(3) establishing a programme of work for the gradual review of synergists and safeners on the market when that Regulation enters into force.
V 2 letih po začetku veljavnosti te uredbe se sprejme uredba v skladu s postopkom iz člena 251 Pogodbe o vzpostavitvi delovnega programa za postopen pregled sinergistov in varoval, ki so na trgu ob začetku veljavnosti te uredbe.
Within 2 years of the entry into force of this Regulation, a Regulation shall be adopted in accordance with the procedure referred to in Article 251 of the Treaty establishing a programme of work 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 poskusov 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.