natgillin/translations-raw huggingface dataset:
Odločitev o tem, ali so pogoji iz člena 29(1)(b) izpolnjeni, se sprejme v skladu s postopkom iz člena 76(2) .
A decision on whether the conditions referred to in Article 29(1)(b) are complied with shall be adopted in accordance with the procedure referred to in Article 76(2).
90-dnevno obdobje se začne na dan, ko država članica, ki preučuje zahtevek za registracijo, sporoči državi članici poročevalki, da se ne strinja z njenim sklepom, v skladu z odstavkom 3.
The 90-day period begins on the date on which the Member State examining the application for authorisation informed the rapporteur Member State that it does not agree with the conclusion of the latter, in accordance with paragraph 3.
Če zadevni državi članici ne dosežeta sporazuma v 180 dneh, država članica, ki preučuje zahtevek za registracijo, predloži zadevo Komisiji.
Where the Member States concerned do not reach agreement within 180 days the Member State examining the application for authorisation shall submit the matter to the Commission.
Odločitev o tem, ali so pogoji iz člena 29(1)(b) izpolnjeni, se sprejme v skladu z regulativnim postopkom iz člena 76(3) .
A decision on whether the conditions referred to in Article 29(1)(b) are complied with shall be adopted in accordance with the regulatory procedure referred to in Article 76(3).
180-dnevno obdobje se začne na dan, ko država članica, ki preučuje zahtevek za registracijo, sporoči državi članici poročevalki, da se ne strinja z njenim sklepom, v skladu z odstavkom 3.
The 180-day period begins on the date on which the Member State examining the application for authorisation informed the rapporteur Member State that it does not agree with the conclusion of the latter, in accordance with paragraph 3.
Zagotoviti je treba kar najhitrejši postopek registracije, ki se bo skladal z visoko ravnijo varovanja zdravja ljudi in okolja.
We need to secure the fastest possible authorisation procedure compatible with a high protection of human health and the environment.
To pa pomeni, da če bodo države članice dodobra upoštevale ustrezne posebne okoliščine na svojem ozemlju, preden bodo odobrile ali zavrnile registracijo sredstva, registriranega v drugi državi članici, namesto da bi samodejno odobrile registracijo, ki velja v drugih državah članicah, 90 dni ni dovolj.
This means, however, that if Member States are to take full account of the relevant and specific circumstances within their territory before authorising or refusing to authorise a product authorised in another Member State - rather than automatically approve the authorisation from another Member State - 90 days is inadequate.
Člen 37, odstavek 5
Article 37, paragraph 5
Podrobna pravila za izvajanje odstavkov 1 do 4 se lahko po posvetovanju z Agencijo določijo v skladu z regulativnim postopkom s pregledom iz člena 76(3a).
Detailed rules for the implementation of paragraphs 1 to 4 may be established in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a) , after consultation of the Authority.
Člen 38, odstavek 1, pododstavek 1 a (novo)
Article 38, paragraph 1, subparagraph 1 a (new)
Komisija mora najkasneje do ...* predstaviti predlog o uvedbi standardiziranega formata za dokumentacijo, določeno v točkah (a), (b) in (c).
Not later than ...*, the Commission shall present a proposal introducing a standardised format for the documentation provided for in points (a), (b) and (c).
* 12 mesecev po začetku veljavnosti te uredbe.
* 12 months after the entry into force of this Regulation.
Treba bi bilo uvesti sistem delitve dela, ki bi pospešil postopek odločanja držav članic, ki registrirajo isti proizvod v EU.
A system of work sharing should be put in place to facilitate the decision making process of Member States that authorise the same product within the EU.
Člen 38, odstavek 1 a (novo)
Article 38, paragraph 1 a (new)
Države članice Agenciji nemudoma zagotovijo dosje z dokumentacijo iz točke 1(a), (b) in (c).
Member States shall, without delay, make available to the Authority a file containing the documentation provided for in points (a), (b) and (c) of paragraph 1.
Agencija hrani register, v katerem so zabeležene vse registracije v različnih državah članicah.
The Authority shall maintain a register in which all authorisations in the different Member States are registered.
Agencija mora kot osrednji organ spremljati različne registracije snovi v različnih državah.
A central body, the Authority should keep track of the various authorisations granted to substances in the different Member States.
Člen 38, odstavek 2
Article 38, paragraph 2
Na zahtevo države članice nemudoma dajo na voljo drugim državam članicam , Agenciji in Komisiji dokumentacijo z dokumenti iz točke 1(a), (b) in (c).
On request, Member States shall, without delay, make available to the other Member States, the Authority and the Commission a file containing the documentation provided for in points (a), (b) and (c) of paragraph 1.
Za pospešitev postopka odločanja, opisanega v členu 35(2), države članice , ki so izdale registracijo, nemudoma dajo na voljo drugim državam članicam in Komisiji dokumentacijo z dokumenti iz točke 1(a), (b) in (c) tega člena .
To facilitate the decision making process described in Article 35(2), Member States having granted an authorisation shall, without delay, make available to the other Member States and the Commission a file containing the documentation provided for in points (a), (b) and (c) of paragraph 1 of this Article .
Države članice v 12 tednih po odločitvi o registraciji fitofarmacevtskega sredstva na javni spletni strani omogočijo dostop do evidence upravnih odločitev iz točke (c) odstavka 1.
Within 12 weeks of a decision on the authorisation of a plant protection product, Member States shall make available a record of the administrative decision as referred to in point (c) of paragraph 1 on a public web site.
Člen 39, odstavek 1
Article 39, paragraph 1
Imetnik registracije lahko zaprosi za registracijo istega fitofarmacevtskega sredstva in za isto uporabo v drugi državi članici, v skladu s postopkom vzajemnega priznavanja iz tega pododdelka , če:
The holder of an authorisation may apply for an authorisation for the same plant protection product and for the same use in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases :
(a) je registracijo izdala država članica (referenčna država članica), ki pripada istemu območju; ali
(a) the authorisation was granted by a Member State (reference Member State )which belongs to the same zone; or
(b) je registracijo izdala država članica za uporabo v rastlinjakih ali za obdelavo po tem, ko se pridelek pobere, ne glede na območje, v katerega spada referenčna država članica.
(b) the authorisation was granted by a Member State for use in greenhouses or as post-harvest treatment, regardless of the zone to which the reference Member State belongs.
Razdelitev na območja registracije ni primerna, saj razmere v predlaganih območjih pogosto niso primerljive.
The division into authorization zones is not appropriate as conditions in the proposed zones are often incomparable.
Zdi se, da Komisija domneva, da so podnebne in okoljske razmere pretežno enake v vseh rastlinjakih in v vseh primerih obdelave po tem, ko se pridelek pobere.
The assumption of the Commission seems to be that the climatologic and environmental conditions in all greenhouses and in all cases of post-harvest treatment are relatively similar.
Ker temu ni tako, je treba črtati ta del člena.
As this is not the case, this part of the article should be deleted.
Država članica, ki ji je predložen zahtevek v skladu s členom 39, natančno preuči oceno referenčne države članice v primerjavi z okoliščinami na svojem ozemlju.
The Member State to which an application under Article 39 is submitted shall examine thoroughly the assessment undertaken by the reference Member State against the circumstances in its own territory.
Načelo medsebojnega priznavanja mora omogočiti državam članicam, da prilagodijo registracijo svojim posebnim razmeram in določijo dodatne pogoje za uporabo ali v ustrezno utemeljenih primerih zavrnejo registracijo določenega sredstva.
The principle of mutual recognition must leave room for Member States to adapt authorisations to their specific situation, by setting additional conditions for use or, in duly substantiated cases, to refuse authorisation of a given product.
Člen 40, odstavka 1 a in 1 b (novo)
Article 40, paragraphs 1 a and 1 b (new)
Država članica odobri registracijo pod pogoji, ki so zanjo pomembni, oziroma je ne odobri, če zahteve iz člena 29 v tej državi članici niso izpolnjene.
The Member State shall grant the authorisation under conditions relevant to that Member State or refuse to grant the authorisation if Article 29 is not fulfilled in that Member State .
Za registracijo lahko veljajo določbe, ki izhajajo iz izvajanja drugih ukrepov v skladu z zakonodajo Skupnosti, in sicer v zvezi s pogoji distribucije in uporabe fitofarmacevtskih sredstev, namenjenih za zaščito zdravja distributerjev, uporabnikov in delavcev.
The authorisation may be subject to provisions resulting from the implementation of other measures in accordance with Community law, relating to the conditions for distribution and use of plant protection products intended to protect the health of the distributors, users and workers concerned.
V skladu s poročilom mora načelo vzajemnega priznavanja državam članicam dopuščati proste roke za odločitev, ali naj se registracija zaradi posebnih razmer v državi lahko izda ali ne.
In line with the rapporteur's report, the principle of mutual recognition must leave room for Member States to decide whether an authorisation should be granted on the basis of the country specific conditions.
Da bi bila zakonodaja kar najbolj jasna, je treba to navesti v členu 40, ki zadeva registracijo, pod naslovom vzajemnega priznavanja.
In order to make the legislation as clear as possible, this should be stated in the relevant Article 40, which concerns authorisation under the heading of mutual recognition.
Člen 40, odstavek 1 c (novo)
Article 40, paragraph 1 c (new)
Za registracijo lahko veljajo dodatne zahteve, če so zaradi ustreznih kmetijskih, fitosanitarnih in okoljskih (vključno s podnebnimi) razmer v državi članici te zahteve nujne za izpolnjevanje pogojev iz člena 29.
The authorisation may be subject to additional requirements when relevant agricultural, plant health and environmental (including climatic) conditions in the Member State make these requirements necessary in order to comply with Article 29.
Ti pogoji morajo v vsakem primeru zajemati:
These use conditions should in any case cover:
– odmerek na hektar pri vsakokratni uporabi,
- the dose per hectare in each application;
– razdobje med zadnjo uporabo in spravilom pridelka,
- the period between the last application and harvest;
– število uporab na leto,
- the number of applications per year;
– utemeljitev nujnosti škropljenja,
- prescription of the need of spraying;
– stopnja nevarnosti/tveganja za človekovo zdravje (kumulativni učinki),
- the level of danger/risk for human health (cumulative effects);
– varstvo podtalnice in ohranjanje biološke raznovrstnosti.
- protection of groundwater and biodiversity.
Glej obrazložitev predloga spremembe člena 40, odstavek 1 a (novo).
See the justification to the amendment to Article 40, paragraph 1 a (new).
Predlog spremembe nadomešča „sistem območij“, ki ga s svojim predlogom uvaja Komisija, in bo državam članicam omogočil več pravic, ne da bi povzročil nepotrebno podvajanje dela ali upočasnjeval postopek odločanja.
The amendment replace the ‘zoning system’ as laid down in the Commission proposal and will give more discretion to Member States without incurring any unnecessary duplication of work and a slower decision-making process.
Z odstopanjem od odstavka 1 in v skladu z zakonodajo Skupnosti se lahko določijo dodatni pogoji v zvezi z zahtevami iz člena 30(3).
By way of derogation from paragraph 1 and subject to Community law, additional conditions may be imposed with respect to the requirements referred to in Article 30(3).
Dodatni pogoji se lahko določijo v zvezi z zahtevami iz člena 30(3).
Additional conditions may be imposed with respect to the requirements referred to in Article 30(3).
Glej obrazložitev predloga spremembe člena 40, odstavek 1 a (novo).
See the justification to the amendment to Article 40, paragraph 1 a (new)
Člen 40, odstavek 2 a (novo)
Article 40, paragraph 2 a (new)
Če država članica meni, da fitofarmacevtsko sredstvo, registrirano v drugi državi članici, ne more izpolniti zahtev iz člena 29 ali je v nasprotju s cilji njenega nacionalnega akcijskega načrta za pesticide in zaradi tega predlaga zavrnitev registracije, o tem obvesti Komisijo, ostale države članice in vlagatelja.
Where a Member State believes a plant protection product authorised by another Member State cannot meet the requirements set out in Article 29 or would counteract the objectives of its National Pesticide Action Plan, and consequently proposes to refuse the authorisation, it shall notify the Commission, the other Member States and the applicant.
Člen 41, odstavek 1, točka (c a) (novo)
Article 41, paragraph 1, point (c a) (new)
(ca) na zahtevo države članice popolno dokumentacijo v skladu s členom 32(3).
(ca) at the request of the Member State a complete dossier as required in Article 32(3).
Če je to potrebno, bi morale države članice imeti vse razpoložljive informacije pred sprejetjem odločitve o registraciji določenega sredstva.
If necessary, Member States should have the full information available before deciding on authorisation of a specific product.
Člen 41, odstavek 2
Article 41, paragraph 2
Država članica, ki ji je zahtevek predložen v skladu s členom 39, se v 90 dneh odloči o zahtevku.
The Member State to which an application under Article 39 is submitted shall decide on the application within 90 days .
Država članica, ki ji je zahtevek predložen v skladu s členom 39, se v 180 dneh odloči o zahtevku.
The Member State to which an application under Article 39 is submitted shall decide on the application within 180 days .
Poglavje III, oddelek 1, pododdelek 4, naslov
Chapter III, Section 1, Subsection 4, title
PODALJŠANJE IN PREKLIC
RENEWAL AND WITHDRAWAL
PODALJŠANJE, SPREMEMBA IN PREKLIC
RENEWAL , AMENDMENT AND WITHDRAWAL
Iz tega naslova je bolje razvidna vsebina pododdelka.
A better reflection of the content of the subsection.
Člen 42, odstavek 3, točka (a)
Article 42, paragraph 3, point (a)
(a) kakršne koli nove informacije, ki jih zahtevajo spremembe zahtev glede podatkov ali meril;
(a) any new information required as a result of amendments in data requirements or criteria;
(a) kakršne koli nove informacije, navedene v uredbi o obnovitvi iz člena 20, ali ki jih zahtevajo spremembe zahtev glede podatkov ali meril;
(a) any new information referred to in the renewal Regulation, as mentioned in Article 20, or required as a result of amendments in data requirements or criteria;
Pojasnitev, katere podatke je treba varovati po podaljšanju registracije za aktivno snov.
Clarification regarding the data to be protected after the renewal of the active substance authorization.
Člen 42, odstavek 3, točka (b)
Article 42, paragraph 3, point (b)
(b) utemeljitev, da so novi predloženi podatki rezultat zahtev po podatkih ali merilih, ki niso veljale, ko je bila izdana registracija za fitofarmacevtsko sredstvo;
(b) justification that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted;
(b) utemeljitev, da so novi predloženi podatki rezultat zahtev po podatkih ali meril, ki niso veljali, ko je bila izdana registracija za fitofarmacevtsko sredstvo , oziroma so bili potrebni za spremembo pogojev za odobritev ;
(b) justification that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of the approval;
Člen 42, odstavek 5
Article 42, paragraph 5
Navodila za organizacijo preverjanj skladnosti se lahko določijo v skladu s postopkom iz člena 76(2) .
Guidelines on the organisation of compliance checks may be established in accordance with the procedure referred to in Article 76(2).
Navodila za organizacijo preverjanj skladnosti se lahko določijo v skladu z regulativnim postopkom s pregledom iz člena 76(3a) .
Guidelines on the organisation of compliance checks may be established in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a).
Člen 43, odstavek 1 a (novo)
Article 43, paragraph 1 a (new)
Države članice pregledajo registracijo, 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.
Member States shall review an authorisation 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.
Če registracija ni v skladu s cilji Direktive 2000/60/ES, ki zadevajo vprašanje snovi, je zelo pomembno, da se omogoči ponovna preučitev registracije.
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 authorisation of the product.
Poleg tega bo ta mehanizem neposrednih povratnih informacij, ki vključuje Direktivo 2000/60/ES in to uredbo, tudi dodatno spodbudil proizvajalce, da resno pretehtajo svojo odgovornost, kar zadeva nadzor nad sredstvi.
Moreover this direct feedback mechanism between Directive 2000/60/EC and this Regulation will also provide an extra incentive for producer to seriously consider their responsibilities in terms of product stewardship.
Člen 43, odstavek 3, točka (c a) (novo)
Article 43, paragraph 3, point (c a) (new)
(ca) na podlagi znanstvenega in tehničnega razvoja se lahko spremenijo uporabljeni odmerki in način njihove uporabe.
(ca) on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified.
Predlagano besedilo ne vsebuje pomembne določbe iz člena 4 (6) Direktive 91/414.
In the proposed text an important provision from Directive 91/414 Article 4(6) is missing.
Ta člen navaja, da se lahko registracija spremeni, če se ugotovi, da se na podlagi znanstvenega in tehničnega razvoja lahko spremenijo odmerki in način njihove uporabe.
This Article states that the authorisation shall be modified if it is established that on the basis of developments in scientific and technical knowledge the manner of use and amount used can be modified.
Ta določba zagotavlja, da pogoji registracije sledijo znanstvenemu razvoju in je primer praktične uporabe načela previdnosti.
This obligation keeps the authorisation conditions up to date with scientific developments and is an example of a practical application of the precautionary principle.
Člen 43, odstavek 4
Article 43, paragraph 4
Če država članica prekliče ali spremeni registracijo v skladu z odstavkom 3, o tem nemudoma obvesti imetnika registracije, druge države članice, Agencijo in Komisijo.
Where a Member State withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the Authority and the Commission.
Druge države članice, ki spadajo v isto območje, registracijo ustrezno spremenijo ali prekličejo.
The other Member States belonging to the same zone shall withdraw or amend the authorisation accordingly.
Člen 45 se uporablja po potrebi.
Article 45 shall apply where appropriate.
Člen 45, odstavek 2
Article 45, paragraph 2
Kadar razlogi za preklic, spremembo ali zavrnitev podaljšanja registracije to dovoljujejo , so podaljšana obdobja za porabo zalog zadevnih fitofarmacevtskih sredstev takšna, da niso v nasprotju z običajnim obdobjem uporabe fitofarmacevtskega sredstva .
Where the reasons for withdrawal, amendment or not renewing the authorisation permit , grace periods for using up stocks of the plant protection products concerned shall be such that they do not interfere with the normal period of use of the plant protection product .
Kadar razlogi za preklic, spremembo ali zavrnitev podaljšanja registracije niso povezani z varovanjem zdravja ljudi in živali ter okolja , rok za porabo zalog zadevnih fitofarmacevtskih sredstev ni daljši od ene sezone .
Where the reasons for withdrawal, amendment or not renewing the authorisation are not related to the protection of human and animal health or the environment , grace periods for using up stocks of the plant protection products concerned shall be granted for a period not longer than one season.
Kadar so razlogi za preklic, spremembo ali zavrnitev podaljšanja registracije povezani z varovanjem zdravja ljudi in živali ter okolja, se za porabo zalog zadevnih fitofarmacevtskih sredstev ne določi roka, vsa prodaja in uporaba pa se prenehata takoj, ko se sprejme odločitev o zavrnitvi podaljšanja ali preklicu.
If the reasons for withdrawal, amendment or not renewing the authorisation are related to the protection of human and animal health or the environment then there shall be no time-period for using up stocks of the plant protection products concerned and all sales and use of such products shall cease with immediate effect once the decision of withdrawal or non-renewal has been taken .
Kjer so razlogi za preklic, spremembo ali zavrnitev podaljšanja registracije povezani z varovanjem zdravja ljudi in živali ter okolja, se morata prodaja in uporaba tovrstnih pesticidov takoj prenehati.
Where the reasons for withdrawal, amendment or not renewing the authorization are related to the protection of human and animal health and the environment then the sale and use of such pesticides should cease with immediate effect.
Člen 45a
Article 45a
Odlaganje in uničenje neregistriranih fitofarmacevtskih sredstev
Disposal and destruction of unauthorised plant protection products
Ne glede na določbe člena 45 se zaloge neregistriranih fitofarmacevtskih sredstev odlagajo varno, za uničenje pa je odgovoren imetnik nazadnje veljavne registracije.
Notwithstanding the provisions of Article 45, stocks of unauthorised plant protection products shall be safely disposed of and destroyed under the responsibility of the former authorisation holder.
Zaloge zastarelih pesticidov v mnogih državah članicah in tretjih državah predstavljajo resno nevarnost za človekovo zdravje in okolje.
Stocks of obsolete pesticides pose serious hazards to human health and the environment in many Member States and third countries.
Proizvajalci bi morali zagotoviti varno odstranitev in uničenje teh nevarnih snovi.
The producers shall be required to assure safe disposal and destruction of these hazardous substances.
Uvožene neživilske snovi ali predmeti ne vsebujejo ostankov aktivnih snovi, ki niso odobrene v skladu z določbami te uredbe.
Imported non-food materials or articles shall not contain residues of active substances that have not been approved in accordance with the provisions of this Regulation.
Da bi zaščitili človekovo zdravje in konkurenčnost evropske industrije, uvožene neživilske snovi ali predmeti ne smejo vsebovati snovi, ki niso odobrene v EU.
In order both to protect human health and the competitiveness of the European industry, imported non-food materials or articles should not contain active substances that have not been approved in the EU.
Člen 46, odstavek 1, točka (a a) (novo)
Article 46, paragraph 1, point (a a) (new)
(aa) njegove aktivne snovi z majhnim tveganjem nimajo škodljivih učinkov za ljudi, živali ali okolje;
(aa) the low-risk active substances contained in it have no adverse effect on humans, animals or the environment;
Za pojasnitev, da lahko med aktivne snovi z majhnim tveganjem štejemo zgolj sredstva, ki nimajo škodljivih učinkov za ljudi, živali ali okolje.
To clarify that only products containing active substances that have no adverse effect on humans, animals or the environment can be considered as low-risk active substances.
Člen 46, odstavek 3, pododstavek 2
Article 46, paragraph 3, subparagraph 2