natgillin/translations-raw huggingface dataset:
Registracija vključuje razvrstitev fitofarmacevtskih sredstev za namene Direktive 1999/45/ES.
The authorisation shall include a classification of the plant protection product for the purpose of Directive 1999/45/EC.
V številnih državah članicah je razvrstitev v skladu z Direktivo 1999/45/ES pogosto prepuščena imetnikom odobritve.
In several Member States classification according to Directive 1999/45/EC is often left to the approval holder.
Da bi dosegli usklajeno označevanje, bi morala ta potekati na ravni Skupnosti.
In order to achieve harmonized labelling, this should be the case at community level.
Za razvrstitev bi moral biti odgovoren prijavitelj in ne območna država članica poročevalka.
The notifier should be responsible for the classification and not the zonal rapporteur Member State .
Prenos te odgovornosti na območno državo članico poročevalko lahko postopek precej upočasni in privede do različnih razvrstitev na posameznih območjih in/ali v vsaki državi članici.
Laying the responsibility with the zonal rapporteur Member State will lead to considerable delays in the process and may lead to different classification in each zone and/or each Member State .
Dolžnost obveščanja sosedov je očitno birokratska, saj so v direktivi o trajnostni rabi predvideni vsi potrebni ukrepi za preprečevanje tveganj.
The necessity to inform neighbours is overtly bureaucratic as the directive on sustainable use foresees all the necessary risk prevention measures.
Oseba, ki želi dati fitofarmacevtsko sredstvo v promet, za registracijo zaprosi osebno ali preko zastopnika v vsaki posamezni državi članici , v kateri se bo fitofarmacevtsko sredstvo dalo v promet .
A person who wishes to place a plant protection product on the market shall apply for an authorisation, in person or via a representative, to each Member State where the plant protection product is intended to be placed on the market .
Oseba, ki želi dati fitofarmacevtsko sredstvo v promet, vloži zahtevek za registracijo , ki bo veljala v celotnem zadevnem območju, osebno ali preko zastopnika v državi članici EU .
A person who wishes to place a plant protection product on the market shall apply for an authorisation, in person or via a representative, to an EU Member State , which shall be valid throughout the zone concerned .
Vseevropska območna registracija je potrebna, da bi dokončno vzpostavili notranji trg za fitofarmacevtska sredstva.
EU-wide zonal authorisation is required in order, finally, to establish a functioning internal market for plant protection products.
Zahtevek preuči država članica , ki jo je predlagal vlagatelj, razen če ga želi preučiti druga država članica z istega območja.
The application shall be examined by the Member State proposed by the applicant, unless another Member State in the same zone agrees to examine it.
Država članica, ki bo preučila zahtevek, o tem obvesti vlagatelja .
The Member State which will examine the application shall inform the applicant .
Zahtevek preuči referenčna država članica v sodelovanju z vsemi državami članicami na določenem območju .
The application shall be examined by the reference Member State , with the involvement of all Member States within a particular zone.
Vse druge države članice v območju morajo pri tem delu sodelovati.
Al l other Member States within a zone should be required to take part in that work.
Obseg dela se razdeli v skladu s predlogom države članice, ki preučuje zahtevek.
The workload should be divided up in accordance with a proposal by the examining Member State .
Druge države članice znotraj območja, katerim je bil predložen zahtevek, prenehajo preučevati zahtevek, dokler država članica, ki preučuje zahtevek, ne predloži ocene.
The other Member States within the zone to which an application has been submitted shall refrain from proceeding with the file pending assessment by the Member State examining the application.
Države članice v območju lahko po posvetovanju s Komisijo sprejmejo podrobna pravila za izvajanje odstavka 1.
Member States in the zone may, after consultation with the Commission, adopt detailed rules for the application of paragraph 1.
Cilj je standardizacija pogojev za registracijo.
The aim is to standardise authorisation conditions.
Države članice bi morale obdržati pravico do določene stopnje prožnosti s privolitvijo Komisije.
Member States should retain the right to a certain degree of flexibility, with the assent of the Commission.
Države članice pod enakimi pogoji odobrijo zadevno fitofarmacevtsko sredstvo , vključno z razvrstitvijo za namene Direktive 1999/45/ES, kot država članica, ki preučuje zahtevek .
The Member States shall authorise the plant protection product concerned under the same conditions , including classification for the purpose of Directive 1999/45/EC, as the Member State examining the application .
Vse države članice v območju ustrezno odobrijo ali zavrnejo registracijo na podlagi sklepov ocene države članice, ki preučuje zahtevek, kot je predvideno v členih 30 in 31.
Al l Member States within a zone shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 30 and 31.
Vse države članice v območju pod enakimi pogoji registrirajo zadevno fitofarmacevtsko sredstvo.
Al l Member States within a zone shall authorise the plant protection product concerned under the same conditions.
Standardizacija registracije.
Standardising authorisation.
Z odstopanjem od odstavka 2 in v skladu z zakonodajo Skupnosti
By way of derogation from paragraph 2 and subject to Community law;
(a) lahko države članice za odobritev določijo posebne pogoje in omejitve uporabe, če obstajajo utemeljeni znanstveni dokazi, da pogoji in omejitve iz prvotne registracije zaradi posebnih pogojev in vzorcev uporabe, prehranjevalnih navad ali drugih pomembnih okoliščin ne zadostujejo;
(a) Member States may subject approval to specific conditions and restriction of use, if there is substantiated, scientific evidence that due to specific conditions of use, use patterns, nutritional habits or other relevant circumstances the conditions and restriction in the original authorisation are not sufficient.
Uporaba in morebitne težave pri uporabi se lahko v državah članicah močno razlikujejo, celo v tistih, ki spadajo na isto območje.
Use and potential problems of use may vary considerably between member states, even those being part of the same zone.
Zato morajo imeti države članice možnost predvideti dodatne pogoje in omejitve uporabe.
Member states should therefore be able to foresee additional conditions and restrictions of use.
Agencija mora kot osrednji organ spremljati različne registracije snovi v različnih državah.
A central body, the Authority should keep track on the different authorisations awarded to substances in the different Member States.
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.
Na zahtevo države članice nemudoma dajo na voljo drugim državam članicam 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 and the Commission a file containing the documentation provided for in points (a), (b) and (c) of paragraph 1.
(Glej obrazložitev predloga spremembe člena 38, odstavek 1 a (novo)).
(See justification amendment on article 38, paragraph 1 a (new)).
Člen 39, odstavek 1, točka (b)
Article 39, paragraph 1, point (b)
(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.
(b) je država članica fitofarmacevtsko sredstvo registrirala za uporabo v rastlinjakih ali za obdelavo po spravilu pridelka ali obdelavo semen , 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 or seed treatment, regardless of the zone to which the reference Member State belongs.
Zaradi poenostavitve trgovine s semeni je treba medobmočno vzajemno priznavanje razširiti tudi na trgovino s semeni.
Interzonal mutual recognition should be extended to seed treatment, to facilitate seed-trade.
Obdelava semen predstavlja majhen in inovativen trg, na katerem prevladujejo mala in srednje velika podjetja.
Seed treatment is a small and innovative market, dominated by small and medium-sized companies.
Visoki stroški registracije in zapleteni postopki bi lahko s trga izrinili vrsto obdelovalnih tehnik, pri katerih se največkrat uporabljajo bistveno manjše količine fitofarmacevtskih sredstev kot pri obdelavi na poljih.
High authorisation costs and complicated procedures would otherwise drive a number of treatment-techniques, which usually use far smaller amounts of PPP than on-field treatment, off the market.
Država članica, ki preučuje zahtevek, proizvode natančno oceni in jih registrira pod strogimi pogoji.
Products are thoroughly evaluated and authorised under strict conditions by the Member State examining the application.
Velik delež snovi bo uvrščen med snovi, ki jih je treba nadomestiti.
A very high proportion of substances will qualify as candidates for substitution.
Tako lahko nastaneta vzporedna sistema odobritve in nepotrebno administrativno breme za države članice, hkrati pa se močno oslabi sistem registracij po območjih.
This would create two parallel approval systems and an unnecessary administrative burden for Member States and would clearly weaken the zonal authorisation concept.
Člen 39, odstavek 2 a (novo)
Article 39, paragraph 2 a (new)
Države članice, ki spadajo na različna območja, lahko postopek vzajemnega priznavanja uporabljajo na prostovoljni osnovi.
Member States belonging to different zones may apply the mutual recognition procedure on a voluntary basis.
V tem primeru se odstavek 1(a) ne uporablja.
In this case paragraph 1(a) shall not apply.
Države, ki ne spadajo na isto območje, bi morale imeti možnost vzajemnega priznavanja na prostovoljni osnovi.
On a voluntary basis mutual recognition should be possible between member states not belonging to the same zone.
V tem primeru ni potrebno razširiti vzajemnega priznavanja na celotno območje.
In this case there should be no need to extend mutual recognition to the entire zone.
Država članica, ki ji je predložen zahtevek v skladu s členom 39, odobri zadevno fitofarmacevtsko sredstvo pod enakimi pogoji, vključno z razvrstitvijo za namene Direktive 1999/45/ES, kot referenčna država članica .
The Member State to which an application under Article 39 is submitted shall authorise the plant protection product concerned under the same conditions, including classification for the purpose of Directive 1999/45/EC, as the reference Member State .
Registracija v skladu s členom 39, velja v celotnem območju .
Authorisation granted under Article 39 shall be valid throughout the zone .
Srednjeročni in dolgoročni cilj mora biti uvedba avtentične registracije EU, kar pomeni, da bi registracija v eni države članice veljala tudi v vseh drugih državah članicah.
The medium- and long-term objective must be to establish a genuine EU authorisation, i.e. authorisation in one Member State would be valid in all other Member States.
Edino tako se lahko omogoči, da bo notranji trg fitofarmacevtskih sredstev deloval.
That is the only way in which a functioning internal market for plant protection products can be created.
Člen 40, odstavek 1 a (novo)
Article 40, paragraph 1 a (new)
Država članica, ki se ji predloži zahtevek v skladu s členom 39, lahko zadevno fitofarmacevtsko sredstvo registrira pod enakimi pogoji kot referenčna država članica, ki ne spada na isto območje.
The Member State to which an application under Article 39 is submitted may authorise the plant protection product concerned under the same conditions, where the reference Member State does not belong to the same zone.
V tem primeru država članica oceni, ali je bil postopek registracije v referenčni državi članici v skladu s postopkom registracije v državi članici iz drugega območja.
In that case the Member State shall assess whether the authorisation procedure in the reference Member State was compatible with the authorisation procedure in the Member State from the different zone.
Vsi deli postopka, ki niso združljivi, se ponovijo.
Any part of the procedure which is not compatible shall be carried out again.
Države članice bi morale imeti možnost prostovoljnega vzajemnega priznavanja snovi, registrirane v državi članici, ki ne spada v isto območje.
On a voluntary basis, Member States should be allowed to mutual recognise an authorisation given to a substance in a Member State which does not belong to the same zone.
V tem primeru morajo oceniti, kateri deli postopka registracije se lahko prevzamejo od referenčne države članice iz drugega območja.
In that case, they should assess which parts of the authorisation procedure can be copied from the reference Member State in the other zone.
Deli postopka, ki niso (dovolj) urejeni, se vseeno izvedejo pred registracijo.
Parts of the procedure which are not (sufficiently) covered should still be executed, before authorisation can be given.
Z odstopanjem od odstavka 1 in v skladu z zakonodajo Skupnosti
By way of derogation from paragraph 1 and subject to Community law
(a) lahko države članice za odobritev določijo posebne pogoje in omejitve uporabe, če obstajajo utemeljeni znanstveni dokazi, da pogoji in omejitve iz prvotne registracije zaradi posebnih pogojev in vzorcev uporabe, prehranjevalnih navad ali drugih pomembnih okoliščin ne zadostujejo,
(a) Member states may subject approval to specific conditions and restriction of use, if there is substantiated scientific evidence that due to specific conditions of use, use patterns, nutritional habits or other relevant circumstances the conditions and restriction in the original authorisation are not sufficient,
Obdobje za registracijo kljub temu ne sme presegati 90 dni, zato da so države članice prisiljene hitro ukrepati in ne uveljavljajo nepotrebnih omejitev in pogojev.
The authorisation period shall nonetheless not exceed 90 days, as to force member states to act quickly and refrain from unnecessary restrictions and conditions.
PODALJŠANJE , SPREMEMBA IN PREKLIC
RENEWAL , AMENDMENT AND WITHDRAWAL
Člen 42, odstavek 3a (novo)
Article 42, paragraph 3a (new)
Pri prvi registraciji se uporabljajo pravila o zaupnosti in varstvu podatkov.
Rules concerning confidentiality and data protection for first authorisation shall apply.
Pravila glede varstva podatkov in zaupnosti bi morala veljati tudi za podaljšanje in pregled registracije.
The rules of data protection and confidentiality should also apply for renewal and review of an authorisation.
Obdobje varstva podatkov je omejeno na pet let (glej člen 56).
The protection period is limited to five years (see Article 56).
Če namerava država članica preklicati ali spremeniti registracijo, o tem obvesti imetnika registracije in mu da možnost, da predloži pripombe.
Where a Member State intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments.
Če namerava država članica preklicati ali spremeniti registracijo, o tem obvesti imetnika registracije in druge države članice z istega območja ter jim da možnost, da predložijo pripombe.
Where a Member State intends to withdraw or amend an authorisation, it shall inform the authorisation holder and the other Member States of the same zone and give them the possibility to submit comments.
Pred preklicem ali spremembo registracije država članica, ki je izvedla revizijo, drugim državam članicam na istem območju, ki so isti proizvod že registrirale, ali pa je ta v postopku registracije, omogoči dostop do svoje ocene.
Before it withdraws or amends an authorisation the Member State which carried out the review shall make available its assessment to the other Member States of the same zone which have authorised the same product or where authorisation is pending in relation thereto.
Da jim možnost, da v razumnem obdobju predložijo pripombe.
It shall give them a reasonable period to submit comments.
Ker ima to, da neka država članica prekliče registracijo, daljnosežne posledice za celotno območje, je treba na isti stopnji kot v postopku registracije v postopek preklica vključiti druge vpletene države članice.
As the withdrawal by one Member States has far reaching consequences in the entire zone, other concerned Member States should be involved in the withdrawal procedure on the same level as in the authorisation procedure.
Če se registracija prekliče v skladu z odstavkom 3(a), ker zahteve iz člena 4(3) niso več izpolnjene, se lahko druga država članica odreče preklicu registracije, če obstajajo utemeljeni znanstveni dokazi, da so zahteve iz členov 29 in 4 zaradi posebnih pogojev in vzorcev uporabe ter drugih pomembnih okoliščin v tej drugi državi članici še vedno izpolnjene.
If the authorisation is withdrawn in accordance with paragraph 3(a) because the requirements of Article 4(3) are no longer met another Member State may refrain from withdrawing the authorisation if there is substantiated scientific evidence that due to specific conditions of use, use patterns or other relevant circumstances the requirements of Article 29 and Article 4 continue to be fulfilled in the other Member State.
Ob preklicu registracije ne bi smelo samodejno priti do preklica na celotnem območju.
A withdrawal of an authorisation should not lead to an automatic withdrawal in the entire zone.
Glede odločitve o preklicu ni bilo posveta z državami članicami.
Member States have not been consulted on the decision of withdrawal.
Pogoji uporabe ali število razpoložljivih proizvodov se lahko v različnih državah članicah istega območja močno razlikujejo.
Conditions of use or the number of products available in different member states of the same zone may vary considerably.
Veljati bi morala tudi pravila o varstvu podatkov in zaupnosti.
The rules of data protection and confidentiality should also apply.
Člen 48, odstavek 1, točka (b)
Article 48, paragraph 1, point (b)
(b) fitofarmacevtsko sredstvo ali kontrolna ali preventivna metoda brez uporabe kemikalij iz točke (a) enakovredno vpliva na ciljne organizme in ne povzroča bistvene gospodarske ali praktične izgube;
(b) the plant protection product or non-chemical control or prevention method referred to in point (a) has equivalent effects on the target organisms and does not present significant economic or practical disadvantages;
Natančnejša opredelitev vidikov, ki jih je treba upoštevati pri primerjalni oceni.
Clarification of aspects to be considered in the comparative assessment.
(c) so raznolikost aktivnih snovi ter vse druge metode in prakse ravnanja s posevki in preprečevanja bolezni ustrezne za čim večje zmanjšanje nastanka odpornosti v ciljnem organizmu.
(c) the diversity of the active substances and all other crop management and disease prevention methods and practices used must be adequate to minimise the occurrence of resistance in the target organism.
Primerjalna ocena upošteva dovoljeno uporabo v manjši meri.
The comparative assessment shall take authorised minor uses into account .
Države članice ponavljajo primerjalno oceno v skladu z odstavkom 1 redno, najpozneje štiri leta po izdaji registracije ali podaljšanju registracije.
Member States shall repeat the comparative assessment provided for in paragraph 1 regularly and at the latest four years after authorisation or renewal of the authorisation was granted.
Država članica poročevalka ponavlja primerjalno oceno v skladu z odstavkom 1 redno, najpozneje štiri leta po izdaji registracije ali podaljšanju registracije.
The rapporteur Member State shall repeat the comparative assessment provided for in paragraph 1 regularly and at the latest four years after authorisation or renewal of the authorisation was granted.
Na podlagi rezultatov te primerjalne ocene države članice registracijo potrdijo, prekličejo ali spremenijo .
Based on the results of that comparative assessment, Member States shall maintain, withdraw or amend the authorisation.
Na podlagi rezultatov te primerjalne ocene država članica poročevalka registracijo potrdi, prekliče ali spremeni .
Based on the results of that comparative assessment, the rapporteur Member State shall maintain, withdraw or amend the authorisation.
Država članica, v kateri je bil izveden postopek registracije, mora ostati odgovorna za registracijo.
The Member State in which the authorisation procedure was conducted should also remain responsible for authorisation.
Če se država članica odloči za preklic ali spremembo registracijo v skladu z odstavkom 3, začne zadevni preklic ali sprememba veljati štiri leta po odločitvi države članice ali na koncu obdobja odobritve možne nadomestne snovi, če se to obdobje konča prej.
Where a Member State decides to withdraw or amend an authorisation pursuant to paragraph 3, that withdrawal or amendment shall take effect four years after the decision of the Member State or at the end of the approval period of the candidate for substitution where that period ends earlier.
Če se država članica poročevalka odloči za preklic ali spremembo registracije v skladu z odstavkom 3, začne zadevni preklic ali sprememba veljati štiri leta po odločitvi države članice ali na koncu obdobja odobritve možne nadomestne snovi, če se to obdobje konča prej.
Where the rapporteur Member State decides to withdraw or amend an authorisation pursuant to paragraph 3, that withdrawal or amendment shall take effect four years after the decision of the Member State or at the end of the approval period of the candidate for substitution where that period ends earlier.
V tem členu pomeni uporaba fitofarmacevtskega sredstva v manjši meri v določeni državi uporabo tega sredstva na posevku, ki v tej državi članici ni splošno razširjen, ali na splošno razširjenem posevku, da se zadovoljijo izjemne potrebe.
For the purpose of this Article, minor use of a plant protection product in a particular Member State means the use of that product on a crop which is not widely grown in that Member State or on a widely grown crop to meet an exceptional need.
V tem členu pomeni uporaba fitofarmacevtskega sredstva v manjši meri v določeni državi uporabo tega sredstva na posevku, ki v tej državi članici ni splošno razširjen, ali na splošno razširjenem posevku, da se zadovoljijo posebne in omejene potrebe , ali obdelavo omejenega ekonomskega pomena za imetnika registracije, vključno z obdelavo semen .
For the purpose of this Article, minor use of a plant protection product in a particular Member State means the use of that product on a crop which is not widely grown in that Member State, or on a widely grown crop to meet a specific and limited need, or as a treatment limited economic interest for the authorisation holder, including seed treatment .
Natančnejša opredelitev uporabe v manjši meri.
Clarification of the definition of minor uses.
Imetnik registracije, uradni ali znanstveni organi, ki sodelujejo v kmetijskih dejavnostih, ali strokovne kmetijske organizacije in uporabniki strokovnjaki lahko zaprosijo za razširitev registracije fitofarmacevtskega sredstva, ki je že registrirano v zadevni državi članici, na uporabe v manjši meri, ki jih registracija še ne vključuje.
The authorisation holder, official or scientific bodies involved in agricultural activities or professional agricultural organisations and professional users may ask for the authorisation of a plant protection product already authorised in the Member State concerned to be extended to minor uses not yet covered by that authorisation.