natgillin/translations-raw huggingface dataset:
To obdobje traja 60 dni, če je za isto fitofarmacevtsko sredstvo z majhnim tveganjem druga država članica z istega območja že izdala registracijo.
The period shall be 60 days where an authorisation has already been granted for the same low-risk plant protection product by another Member State located in the same zone .
To obdobje traja 60 dni, če je za isto fitofarmacevtsko sredstvo z majhnim tveganjem druga država članica že izdala registracijo.
The period shall be 60 days where an authorisation has already been granted for the same low-risk plant protection product by another Member State.
Člen 46, odstavek 3, pododstavek 3
Article 46, paragraph 3, subparagraph 3
Če država članica potrebuje dodatne informacije, določi rok, v katerem jih mora vlagatelj predložiti.
Where the Member State needs additional information, it shall set a time limit for the applicant to supply it.
V tem primeru se obdobje 90 dni podaljša za dodatno časovno obdobje, ki ga odobri država članica.
In that case, the 90-day period shall be extended by the additional time limit granted by the Member State.
Celotno obdobje ne sme biti daljše od štirih mesecev.
The total period may not exceed four months.
Določiti je treba jasne časovne omejitve za vse ukrepe v okviru uredbe.
Clear time limits must be set for all measures under the Regulation.
Dajanje fitofarmacevtskih sredstev z manjšim tveganjem v promet in njihova uporaba
Placing on the market and using reduced risk plant protection products
Ne glede na določbe člena 29 je fitofarmacevtsko sredstvo označeno kot sredstvo z majhnim tveganjem, če so izpolnjene naslednje zahteve:
Notwithstanding Article 29, a plant protection product shall be authorised as a reduced risk product if it satisfies the following requirements:
(a) vsaj ena od aktivnih snovi, ki jih vsebuje, je snov, ki je opredeljena v členu 22 (aktivna snov z majhnim tveganjem);
(a) at least one of the active substances that it contains is a substance as defined in Article 22 (“Low-risk active substances”);
(b) vse aktivne in zaščitne snovi ter sinergisti z majhnim tveganjem, ki jih vsebuje, so odobreni v skladu s poglavjem II;
(b) all the active substances, protective substances and synergistic products with a low risk that it contains are approved in accordance with Chapter II;
(c) glede na znanstvene ali tehnične podatke manj ogrožajo zdravje ljudi in živali ali okolje kot primerljivo fitofarmacevtsko sredstvo, ki je že registrirano;
(c) it entails, in the light of scientific or technical knowledge, considerably fewer risks to human or animal health or the environment than a comparable plant protection product that is already authorised;
(d) je dovolj aktivno;
(d) it is sufficiently active;
(e) je v skladu s členom 29(1)(b), (c) in (e) do vključno (h).
(e) it complies with Article 29(1)(b), (c) and (e) to (h).
Vlagatelji za registracijo fitofarmacevtskega sredstva z majhnim tveganjem morajo dokazati, da izpolnjuje pogoje iz odstavka 1, in zahtevku priložiti podrobno in strnjeno dokumentacijo za vsako točko zahtevanih podatkov o aktivni snovi in fitofarmacevtskem sredstvu.
Applicants for authorisation of a reduced risk plant protection product must demonstrate that it meets the conditions in paragraph 1 and enclose with the application a detailed and a summary dossier for each point of the details required for the active substance and the plant protection product.
Država članica v 120 dneh sprejme odločitev o odobritvi zahtevka za registracijo fitofarmacevtskega sredstva z majhnim tveganjem.
The Member State shall decide within 120 days whether to approve an application for authorisation for a reduced risk plant protection product.
To obdobje traja 90 dni, če je druga država članica v istem območju že izdala registracijo za isto fitofarmacevtsko sredstvo z manjšim tveganjem.
This period shall be 90 days if another Member State from the same zone has already granted authorisation for the same reduced risk plant protection product.
Če država članica zahteva dodatne informacije, določi rok, v katerem jih mora vlagatelj predložiti.
If the Member State requires additional information, it shall set a deadline by which the applicant must provide the information.
V tem primeru se obdobje 120 dni podaljša za dodatno obdobje, ki ga odobri država članica.
In such a case the period of 120 days shall be extended by the additional period that the Member State has granted.
Če ni določeno drugače, se v zvezi z registracijo uporabljajo vse določbe te uredbe.
Unless stated otherwise, all the provisions of this Regulation relating to authorisations shall apply.
Da bi spodbudili razvijanje manj škodljivih fitofarmacevtskih sredstev, se uvaja nova kategorija fitofarmacevtskih sredstev z majhnim tveganjem, ki povzročajo manjše tveganje kot sredstva, ki so že na trgu in vsebujejo vsaj eno snov z majhnim tveganjem.
To encourage the development of less harmful plant protection products, this introduces a new category of low-risk plant protection products that present a lower risk than current products on the market and contain at least one low-risk active substance.
Tej kategoriji fitofarmacevtskih sredstev bi bilo treba dati prednost, na primer s podaljšanim obdobjem varstva podatkov in davčno oprostitvijo.
This category of plant protection products should receive certain advantages such as a longer period of data protection and tax exemption.
Člen 48, odstavek 1, uvodni del in točki (a) in (b)
Article 48, paragraph 1, introductory part and points (a) and (b)
Države članice ne registrirajo fitofarmacevtskega sredstva, ki vsebuje možno nadomestno snov, če primerjalna ocena, ki preuči tveganja in koristi, kot je določeno v Prilogi IV, pokaže da:
Member States shall not authorise a plant protection product containing a candidate for substitution where a comparative assessment weighing up the risks and benefits, as set out in Annex IV, shows that:
Države članice ne registrirajo za uporabo na zadevnih kulturnih rastlinah fitofarmacevtskega sredstva, ki vsebuje snov, ki jo je treba nadomestiti , ali pomeni večjo nevarnost, če primerjalna ocena, ki preuči tveganja in koristi, kot je določeno v Prilogi IV, pokaže da:
Member States shall not authorise for use in a given crop a plant protection product either containing a candidate for substitution or posing a higher risk where a comparative assessment weighing up the risks and benefits, as set out in Annex IV, shows that:
(a) za načine uporabe, navedene v zahtevku, je enako učinkovito registrirano fitofarmacevtsko sredstvo ali enako učinkovita kontrolna ali preventivna metoda brez uporabe kemikalij z enako učinkovitostjo že registrirano in je bistveno varnejše za zdravje ljudi ali živali ali za okolje;
(a) for the uses specified in the application an equally effective authorised plant protection product, or an equally effective non-chemical control or prevention method, having equivalent efficacy is already authorised and is significantly safer for human or animal health or the environment;
(b) fitofarmacevtsko sredstvo ali kontrolna ali preventivna metoda brez uporabe kemikalij iz točke (a) ne povzroča bistvene gospodarske ali praktične izgube;
(b) the plant protection product or non-chemical control or prevention method referred to in point (a) does not present significant economic or practical disadvantages;
(b) nadomestitev s fitofarmacevtskimi sredstvi ali kontrolnimi ali preventivnimi metodami brez uporabe kemikalij iz točke (a) ne povzroča bistvene gospodarske ali praktične izgube;
(b) the substitution by plant protection product s or non-chemical control or prevention method s referred to in point (a) does not present significant economic or practical disadvantages;
Nadomestne snovi bi morale biti temelj moderne politike za registracijo.
Substitution should be the back-bone of a modern authorisation policy.
Države članice ne odobrijo sredstva, ki vsebujejo snov, ki jo je treba nadomestiti, če obstajajo varnejše nadomestne rešitve ali razpoložljive metode za določne kulturne rastline.
Products that contain a candidate for substitution shall not be approved by Member States if there are safer alternatives or methods available for a given crop.
V nasprotnem primeru bi kmetje ostali brez ustreznih sredstev za zaščito svojega pridelka.
Otherwise farmers would be left without adequate means to protect their harvest .
Člen 48, odstavek 1, točka (c)
Article 48, paragraph 1, point (c)
(c) je kemijska raznolikost aktivnih snovi ustrezna za čim večje zmanjšanje nastanka odpornosti v ciljnem organizmu.
(c) the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target organism.
(c) so kemijska raznolikost aktivnih snovi , če je potrebno, ali metode in prakse pridelave kulturnih rastlin in zatiranja škodljivcev ustrezne za čim večje zmanjšanje nastanka odpornosti v ciljnem organizmu.
(c) the chemical diversity of the active substances, where relevant, or methods and practices of crop management and pest prevention are adequate to minimise the occurrence of resistance in the target organism.
Pri določbah o nadomestnih snoveh je treba upoštevati tudi metode, ki ne predvidevajo uporabe kemičnih sestavin, in prakse upravljanja s kulturnimi rastlinami in zatiranja škodljivcev.
Non-chemical methods and practises of crop management and pest prevention must also be taken into consideration in the provisions for substitution .
Člen 48, odstavek 1, pododstavek 1 a (novo)
Article 48, paragraph 1, subparagraph 1 a (new)
Države članice ne registrirajo fitofarmacevtskega sredstva, kadar primerjalna ocena pokaže, da obstajajo varnejše alternative, vendar imajo snovi, ki jih je treba nadomestiti, prednost pri primerjalnih ocenah in nadomeščanju.
While Member States shall not authorise any plant protection product where a comparative assessment shows the existence of safer alternatives, priority in comparative assessment and substitution shall be given to candidates for substitution.
Četudi bi bilo treba nadomestiti vsa sredstva, imajo države članice omejena finančna sredstva, zato je treba pri primerjalni ocenah in nadomeščanju dati prednost snovem, ki jih je treba nadomestiti.
Although all products might be liable for substitution, Member States have limited resources and therefore priority in comparative assessment and substitution shall be given to candidates for substitution.
Člen 48, odstavek 3
Article 48, paragraph 3
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.
Države članice ponovijo primerjalno oceno v skladu z odstavkom 1 samo enkrat in najpozneje štiri leta po izdaji registracije ali podaljšanju registracije.
Member States shall repeat the comparative assessment provided for in paragraph 1 only once 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 prve primerjalne ocene države članice registracijo potrdijo, prekličejo ali spremenijo.
Based on the results of the first comparative assessment, Member States shall maintain, withdraw or amend the authorisation.
Po drugi primerjalni oceni registracijo prekličejo.
After the second comparative assessment, Member States shall withdraw the authorisation.
Snovi, ki jih je treba nadomestiti, se na trgu ne sme pustiti neomejeno dolgo, pač pa jih je treba po drugi primerjalni oceni umakniti.
Candidates for substitution should not be allowed on the market indefinitely but should be removed after the second comparative assessment.
Člen 48, odstavek 4
Article 48, paragraph 4
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 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 dve leti po odločitvi države članice ali na koncu obdobja odobritve možne snovi, ki jo je treba nadomestiti , 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 two 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.
Predlagani dveletni rok let bo pospešil postopek, ki zadeva snov, ki jo je treba nadomestiti, in bo spodbudil inovacije.
The proposed deadline of two years will speed up the process of substitution and give incentive for innovation.
Člen 49, odstavek 1
Article 49, paragraph 1
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 kulturnih rastlinah , ki v tej državi članici niso splošno razširjene (ne več kot 0,1 % kmetijskih površin države članice) , ali na splošno razširjenih kulturnih rastlinah , 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 (not more than 0,1 % of the agricultural area of the Member State) or on a widely grown crop to meet an exceptional need.
Manj razširjene kulturne rastline so tiste, ki niso najpomembnejše (žito, koruza).
Minor uses are considered now every crop which is not a major crop (cereals, maize).
Jabolka se v 15-članski EU pridelujejo na 300.000 hektarjih, kar je približno 0,25 % kmetijskih površin.
Apples are grown on 300.000 ha in EU 15, about 0.25 % of the agricultural area.
Člen 49, odstavek 2 a (novo)
Article 49, paragraph 2 a (new)
Po odobritvi Komisije lahko države članice sprejmejo posebne ukrepe, ki lajšajo predložitev zahtevkov za razširitev registracije in zahtevkov za uporabo v manjši meri.
Member States may, after authorisation by the Commission, adopt specific measures to facilitate the submission of applications to extend the authorisation for and the submission of applications relating to minor uses.
Poenostavitev birokratskih postopkov in spodbujanje vpletenih k uporabi fitofarmacevtskih sredstev tudi za načine, ki so manj pogosti, bo razrešilo številne težave v zvezi z določenimi kulturnimi rastlinami.
Simplification of bureaucracy and encouragement of those concerned to employ plant protection products for minor uses will resolve numerous problems in relation to certain crops.
Ugotovljeno je bilo, da imetniki registracij niso naklonjeni razširitvi registracij na uporabo v manjši meri zaradi pomanjkanja gospodarskega interesa za industrijo.
It has been noted that authorisation holders are reluctant to extend authorisations to minor uses owing to the lack of economic interest to industry.
V nekaterih tretjih državah se izvajajo ukrepi, kot je zaščita podatkov za daljše obdobje, če je registracija razširjena na manj razširjene kulturne rastline.
Measures are applied in some third countries, such as protection of data for a longer period, provided the authorisation has been extended to minor crops.
V EU je treba predvideti podobne spodbude, da bi se izognili pomanjkanju fitofarmacevtskih sredstev za te vrste kulturnih rastlin.
Provision should be made for similar incentives in the EU in order to avoid a shortage of plant protection products for this type of crop.
Člen 49, odstavek 3, točka (d)
Article 49, paragraph 3, point (d)
(d) so bile dokumentacija in informacije v podporo razširitvi uporabe predložene s strani oseb ali organov iz odstavka 2.
(d) the documentation and information to support an extension of use has been submitted by the persons or bodies referred to in paragraph 2.
Študije, ki so potrebne za določitev najvišjih mejnih vrednosti ostankov, lahko izvajajo znanstvene ustanove ali uradni organi.
The studies necessary in order to determine maximum residue levels may be carried out by scientific institutes or official bodies.
Stroški znanstvenih študij predstavljajo veliko oviro razvoju na področju uporabe v manjši meri.
The cost of scientific studies constitutes a very serious obstacle to the development of minor uses.
Cilj predloga spremembe je prispevati k rešitvam, ki so z gospodarskega vidika lažje izvedljive.
The amendment is intended to offer solutions that are more viable from an economic point of view.
Člen 49, odstavek 4, pododstavek 1 a (novo)
Article 49, paragraph 4, subparagraph 1 a (new)
Ne glede na kakšen način se v državi članici izda razširitev registracije za uporabe v manjši meri mora biti jasno razvidno, da gre za razširitev v skladu s členom 49, da bi tako pokazali na drugačen pravni status v primerjavi z registracijo v skladu s členom 4.
Regardless of how an extension of the authorisation for minor uses is granted in a Member State, it must be made clear that this is an extension under Article 49 in order to highlight the different legal status compared to an authorisation under Article 4.
Člen 49, odstavek 4 a (novo)
Article 49, paragraph 4 a (new)
V skladu z regulativnim postopkom iz člena 76(3) se lahko sprejme uredba o oblikovanju evropskega sklada za spodbujanje sodelovanja med raziskovalnimi inštituti v državah članicah na področju raziskovanja uporabe kulturnih rastlin pri gojenju v manjšem obsegu.
In accordance with the regulatory procedure referred to in Article 76(3) a regulation may be adopted to create a European fund to encourage cooperation between research institutes in the Member States with regard to research into the use of crops in small-scale cultivation.
Sklad za gojenje v manjšem obsegu bi moral, podobno kot skladi v številnih evropskih državah članicah, jasno pokazati pot k strukturnemu pristopu, ki bo spodbujal najboljše prakse in povečal uporabe ustreznih fitofarmacevtskih sredstev.
A fund for small-scale applications, similar to the funds which exist in a number of European Member States, should point the way towards a structural approach to encourage best practices and increase the use of the right plant protection products.
Če države članice odobrijo razširitev registracije na uporabe v manjši meri, o tem obvestijo imetnika registracije in od njega zahtevajo , da v skladu s tem spremeni oznako.
When Member States grant an extension of authorisation for a minor use, they shall inform the authorisation holder and request him to change the labelling accordingly.
Če države članice odobrijo razširitev registracije na uporabo v manjši meri, o tem obvestijo imetnika registracije, ki v skladu s tem spremeni oznako.
When Member States grant an extension of authorisation for a minor use, they shall inform the authorisation holder, who shall change the labelling accordingly.
Če imetnik registracije odkloni, države članice zagotovijo, da so uporabniki obveščeni o obsežnih in podrobnih navodilih za uporabo, ki se uradno objavijo ali so na voljo na uradni spletni strani.
Where the authorisation holder declines, the Member States shall ensure that users are fully and specifically informed as to instructions for use, by means of an official publication or an official website.
Oznaka navaja, da imetnik registracije ne zagotavlja varnosti in učinkovitosti razširjene uporabe.
The labelling shall indicate that the authorisation holder does not guarantee the safety and efficiency of extended use.
Na oznaki je zapisano, da učinkovitost ali fitotoksičnost takšnih vrst uporabe še nista bili ovrednoteni.
The label shall indicate that such uses have not been evaluated for efficacy or phytotoxicity.
Ne glede na člen 70 imetnik registracije ni odgovoren za kakršno koli škodo zaradi uporabe v skladu z razširjeno registracijo.
Without prejudice to Article 70, the authorisation holder shall not be liable for any losses arising from use in accordance with extensions of authorisation.
Pravilno označevanje je nadvse pomembno za varno uporabo fitofarmacevtskih sredstev.
A correct labelling is pre-eminent for safe use off PPPs.
Najboljši način za obveščanje uporabnika je, da se uporaba v manjši meri navede na etiketi ter da se jasno navede, da odgovornosti za navedene vzorce uporabe ne nosi proizvajalec.
The best way to inform the user is to indicate minor uses on the label and clearly indicate that liability for the indicated use patterns does not lie with the producer.
Imetniki registracij ne morejo biti odgovorni za škodljive učinke razširjene uporabe, a so zaradi tega vseeno zaskrbljeni.
Authorisation holders could not be held liable for adverse effects of extensions of use, but authorisation holders still remain concerned on this point.
V predlogu spremembe je jasno zapisano, da ne nosijo odgovornosti, zato niso več potrebni drugačni načini obveščanja, kadar imetniki registracije razširjene uporabe nočejo zapisati na oznaki.
This amendment would make clear that they would incur no liability and hence remove the need for alternative publicity should they refuse to add extensions of use to the label.
Potrebna je opredelitev za namene izvrševanja.
A definition is needed for enforcement purposes.
Člen 49, odstavek 6
Article 49, paragraph 6
Države članice sestavijo in redno posodabljajo seznam uporab v manjši meri.
Member States shall establish and regularly update a list of minor uses.
Seznam mora biti javno dostopen na uradnih spletnih straneh države članice in Komisije.
This list shall be made available to the public through official websites of the Member State and of the Commission .
Da bi olajšali izmenjavo podatkov in izboljšali obveščanje zainteresirane javnosti, države članice in Komisija seznam objavijo na uradni spletni strani.
To facilitate the exchange of information and improve the information of the interested public Member States and the Commission must make the list available on an official website.
Člen 50, naslov
Article 50, title
Izredne razmere v kmetijstvu
Agricultural emergency situations
Izredna registracija
Emergency authorisations
Predlog za spremembo naslova bi razjasnil vsebino tega člena in omogočil izredno registracijo v drugih nekmetijskih okoliščinah, kot sta zaščita pred poplavami ter nadzor nad invazivnimi vrstami.
The amended title would clarify the subject matter of this article and provide for emergency authorisations in other non-agricultural circumstances, such as flood defence and control of invasive species.
Člen 50, odstavek 1, pododstavek 1
Article 50, paragraph 1, subparagraph 1
Z odstopanjem od člena 28 lahko država članica v posebnih okoliščinah dovoli za obdobje največ 30 dni dajanje v promet fitofarmacevtskih sredstev, za omejeno in nadzorovano uporabo, če je ta ukrep potreben zaradi nepredvidene nevarnosti ali drugih izrednih razmer s področja uporabe te uredbe , ki jih ni mogoče obvladati z drugimi ustreznimi ukrepi.
By way of derogation from Article 28, in special circumstances a Member State may authorise for a period not exceeding 30 days the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of an unforeseeable danger or other emergency within the scope of this Regulation which cannot be contained by any other reasonable means.