natgillin/translations-raw huggingface dataset:
Imetnik registracije, uradni ali znanstveni organi, ki sodelujejo v kmetijskih dejavnostih, ali ki jih je država članica izrecno določila kot pristojne organe, 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 having been specifically declared responsible by the Member State, 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.
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 posevki.
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.
Opaiti 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 posevke.
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 posevkov.
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 (c)
Article 49, paragraph 3, point (c)
(c) je razširitev v javnem interesu;
(c) the extension is in the public interest;
(c) je razširitev v javnem interesu, tudi glede obvladovanja odpornosti in potrebe, da imajo kmetje na voljo zanesljiva in varna fitofarmacevtska sredstva, ki so bila preverjena ;
(c) the extension is in the public interest, including as regards resistance management and the need to provide farmers with reliable and safe plant protection products, which have been subject to examination ;
Pojasnitev izraza „javni interes“.
Clarification of the term 'public interest'.
Znanstvene ustanove in uradni organi lahko izvajajo študije, ki so potrebne za določitev zgornjih mejnih vrednosti ostankov.
It shall be possible for scientific institutions or official bodies to carry out the studies required to set maximum residue limits.
Stroški znanstvenih študij predstavljajo veliko oviro razvoju na področju uporabe v manjši meri.
The costs involved in scientific studies constitute a major obstacle to development as regards minor uses.
Cilj tega predloga spremembe je predlagati pristope, ki so gospodarsko bolj izvedljivi.
The aim of this amendment is to suggest approaches that are more economically viable.
Registracija za uporabo v manjši meri med drugim temelji na ekstrapolaciji podatkov, pridobljenih za druge pridelke z znatnimi botaničnimi in agronomskimi podobnostmi.
Authorisation for minor uses shall be based, inter alia, on extrapolation of data obtained for other crops with which there are significant botanical and agronomic similarities.
Za pridelke, med katerimi obstajajo velike podobnosti, kot na primer med češnjami in trnuljami, se izhodiščni podatki, pridobljeni za registracijo, ekstrapolirajo in na ta način se registracija lažje razširi na uporabo v manjši meri.
For crops between which there are major similarities, such as for example between cherry trees and blackthorn, initial data obtained for authorisation should be extrapolated to make it easier to extend authorisations for minor uses.
Države članice najkasneje do [datum začetka veljavnosti + 18 mesecev] sprejmejo zakone, predpise in upravne določbe, potrebne za razrešitev kakršnih koli pravnih in gospodarskih vprašanj, vključno s pošteno in pravično razdelitvijo stroškov in odgovornosti med prvotnim imetnikom registracije in organi javne oblasti.
Member States shall bring into force the laws, regulations and administrative provisions necessary toresolve any legal and economic issues by [date of entry into force + 18 months] at the latest, , including a fair and just distribution of costs, responsibilities and liability between the original authorisation holder and the public authorities.
Države članice lahko ustanovijo sklad, ki ga financirajo zadevne strani in/ali javne sklade za sponzoriranje raziskav o uporabi v manjši meri in/ali za pokritje stroškov podaljšanja prvotne registracije.
The Member States may establish a fund financed by the parties concerned and/or public funds to sponsor research on minor uses and/or to cover the costs of extending the original authorisation.
Komisiji nemudoma posredujejo besedilo teh določb in primerjalno tabelo med temi določbami in to direktivo.
They shall forthwith communicate to the Commission the text of the abovementioned provisions and a correlation table between those provisions and this regulation.
Agencija, Komisija in države članice sodelujejo in usklajujejo svoje znanstveno delo v zvezi z uporabo v manjši meri.
The Authority, the Commission and Member States shall cooperate and coordinate their scientific work with regard to minor uses.
Registracijo fitofarmacevtskih sredstev za uporabo v manjši meri je treba olajšati.
The authorisation of plant protection products for minor uses needs to be facilitated.
Uporabniki za boj proti škodljivcem pogostokrat uporabljajo neregistrirane, nepregledane proizvode, za proizvajalce pa uporaba v manjši meri ne predstavlja večjega ekonomskega interesa.
Users tend to use unauthorised, not examined products to combat pests, whereas for the producers minor uses are economically of little interest.
Pomembno je, da države članice in Komisija tesno sodelujejo, še posebej pri raziskavah uporabe v manjši meri.
It is important that Member States and Commission work closely together, especially on research for minor uses.
Člen 49, odstavek 4 b (novo)
Article 49, paragraph 4 b (new)
V skladu s 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 posevkov pri gojenju v manjšem obsegu.
In accordance with the 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.
Člen 49, odstavek 4 c (novo)
Article 49, paragraph 4 c (new)
V skladu s postopkom iz člena 76(3) se sprejme uredba o podaljšanju obdobja varstva podatkov v skladu s členom 56(2) za obdobje do pet let, odvisno od števila podaljšanj, odobrenih za uporabo v manjši meri.
In accordance with the procedure referred to in Article 76(3) a regulation shall be adopted providing for a prolongation of the period for data protection in accordance with Article 56(2) for up to five years, depending on the number of extensions for minor use granted.
Spodbuda proizvajalcem, da podprejo uporabo v manjši meri, je možno podaljšanje obdobij varstva podatkov.
An incentive for producers to support minor uses is a possible extension of the data protection periods.
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.
Najboljši način za obveščanje uporabnika je, da se uporaba v manjši meri navede na nalepki 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.
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 shall make available the list on an official website.
Z odstopanjem od člena 28(1) lahko države članice dovolijo uvoz fitofarmacevtskega sredstva in njegovo dajanje v promet na svojem območju preko vzporedne trgovine le na osnovi upravnega postopka, v katerem se preveri, ali je proizvod istoveten z že registriranim fitofarmacevtskim sredstvom („referenčnim fitofarmacevtskim sredstvom“).
By way of derogation from Article 28(1), Member States shall allow the import and placing on the market of a plant protection product within their territory through parallel trade only after an administrative procedure to verify that it is identical to the plant protection product which is already authorised (‘reference plant protection product’).
Če se ugotovi istovetnost, pristojni organ imenovane države članice zanj izstavi potrdilo o istovetnosti.
Where this is the case, the imported plant protection product shall receive an identity certificate from the competent authority of the designated Member State .
Uvozniki fitofarmacevtskega sredstva pri pristojnem organu imenovane države članice zaprostijo za potrdilo o istovetnosti fitofarmacevtskega sredstva, ki ga želijo uvoziti, in sicer pred prvim uvozom in prvim dajanjem v promet.
The importers of a plant protection product shall apply for an identity certificate from the competent authority of the designated Member State for the plant protection product they want to import before the first import and the first placing on the market.
Pristojni organ imenovane države članice se v 45 dneh odloči, ali so zahteve iz tega odstavka izpolnjene.
The competent authority of the designated Member State shall decide within 45 days if the requirements under this paragraph are fulfilled.
Če pristojni organ ugotovi, da so zahteve iz tega odstavka izpolnjene, uvoznik za zadevni proizvod prejme potrdilo o istovetnosti.
If the authority ascertains that the requirements under this paragraph are fulfilled, the importer shall receive an identity certificate for the product in question.
Prosilcu ni treba predložiti poročil o podatkih, poskusih in študijah, ki se zahtevajo za registracijo fitofarmacevtskega sredstva.
The applicant shall be exempted from supplying the information, test and study reports required for an authorisation of a plant protection product.
Pristojni organ, ki prejme zahtevek, zaprosi pristojni organ države izvora, naj:
The competent authority receiving the application shall ask the competent authority of the country of origin:
(a) ugotovi natančno sestavo proizvoda, da lahko preveri, ali je to istovetno s fitofarmacevtskim sredstvom, ki je registrirano v referenčni državi članici, ter
(a) to establish the exact composition of the product to check that it is identical to a plant protection product authorised in the reference Member State, and
(b) preveri, ali je proizvod v tej državi članici registriran v skladu s postopkom registracije iz Direktive 91/414/EGS ali te uredbe.
b) to check that the product is authorised in that Member State in accordance with the authorisation procedure laid down in Directive 91/414/EEC or in this Regulation.
Vzporedno uvoženih proizvodov se ne sme prepakirati.
Products subject to parallel imports cannot be repackaged.
Potrdilo o istovetnosti poteče z registracijo referenčnega proizvoda ali s potekom registracije uvoženega proizvoda v državi izvoznici.
The identity certificate shall expire with the authorisation of the reference product or the expiry of the authorisation of the imported product in the Member State from which it is exported.
Če se registracija referenčnega proizvoda prekliče iz razlogov, ki niso povezani z zdravjem ali okoljem, lahko uvoznik uvoženi proizvod prodaja še eno leto po datumu preklica.
If the authorisation of the reference product is withdrawn for reasons other than health or environmental reasons, the importer may continue to sell the imported product for one year after the date of withdrawal.
Poročevalec ima prav, ko se strinja z vzpostavitvijo jasnih in strogih pravil na ravni Skupnosti, ki bodo urejala vzporedno trgovino z namenom, da se dosežejo visoke ravni usklajenosti, varnosti in nadzora.
The rapporteur is right to come out in favour of the establishment at Community level of clear and strict rules governing parallel trade with a view to attaining high levels of harmonisation, safety and monitoring.
Da se zagotovi identičnost uvoženega z referenčnim proizvodom, pa ponovno pakiranje ne bi smelo biti dovoljeno.
Nevertheless, with a view to guaranteeing that the imported product is identical to the reference product, re-packaging should not be permitted.
Poleg tega je izvajanje vseh upravnih nalog za preverjanje identičnosti proizvoda in predhodne registracije v državi izvoznici naloga pristojnega organa v namembni državi članici in ne vlagatelja zahtevka.
Furthermore, it is the job of the competent authority in the receiving Member State, not the applicant, to carry out all the administrative tasks to check that the product is identical and that it has been the subject of prior authorisation in the exporting country.
Člen 50, odstavek 4 a (novo)
Article 50, paragraph 4 a (new)
Odstavki od 1 do 3 člena 49 se nanašajo tudi na fitofarmacevtska sredstva, ki se zahtevajo za uporabo v manjši meri, če ni drugega načina za ekonomsko primerno varstvo rastlin.
Paragraphs 1 to 3 and Article 49 shall also apply to plant protection products that are required for minor uses if there is no other way to ensure plant protection in an economically sound way.
Z odstopanjem od odstavka 1 obdobje registracije ne sme biti daljše od treh let.
By way of derogation from paragraph 1, the period of authorisation shall not exceed three years.
Morda bi bilo treba proizvod za uporabo v manjši meri registrirati za omejeno časovno obdobje, tudi če aktivna snov še ni bila registrirana ali v primeru, ko je bilo fitofarmacevtsko sredstvo registrirano v drugi državi članici, proizvajalec pa ne kaže interesa, da bi tam tržil svoje proizvode.
There might be a need to grant an authorisation for a limited time-period to a product for minor uses, even if the active substance has not yet been authorised or where the plant protection product has been authorised in another member state, but the producer shows no interest to market his products in the member state concerned.
To bi bila najbrž najboljša rešitev, saj je izbira fitofarmacevtskih sredstev za uporabo v manjši meri zelo omejena, uporabljene količine in tveganja pa razmeroma nizka.
It seems to be the best solution as the choice of plant protection products for minor uses is very limited and the amounts used and the risks are comparatively small.
Uporabo proizvoda bi bilo treba vedno nadzorovati.
The product should only be used in a controlled way.
Z odstopanjem od člena 28 se poskusi ali testi za raziskovalne in razvojne namene, ki vključujejo izpust neregistriranega fitofarmacevtskega sredstva v okolje, lahko izvajajo, če je država članica, v kateri se izvaja poskus ali test, ocenila razpoložljive podatke in izdala dovoljenje za namene poskusov .
By way of derogation from Article 28, experiments or tests for research or development purposes involving the release into the environment of an unauthorised plant protection product may be carried out if the Member State in whose territory the experiment or test is to be carried out has assessed the available data and granted a licence for trial purposes.
Dovoljenje lahko omeji uporabljeno količino in obravnavana področja ter določi dodatne pogoje za preprečevanje škodljivih vplivov na zdravje ljudi ali živali in nesprejemljivih škodljivih vplivov na okolje, kot je potreba po preprečevanju vstopa v prehranjevalno verigo hrane in krme, ki vsebuje ostanke, razen če je bila v skladu z Uredbo (EC) št. 396/2005 že uvedena ustrezna določba.
The licence may limit the quantities to be used and the areas to be treated and may impose further conditions to prevent any harmful effects on human or animal health or any unacceptable adverse effect on the environment, such as the need to prevent entry into the food chain of feed and food containing residues unless a relevant provision has already been established under Regulation (EC) No 396/2005.
Poskusov in testov ni potrebno registrirati, ampak se zanje izda zgolj dovoljenje.
For experiments and tests it is not necessary to grant authorisation but simply a licence.
Podrobna pravila za uporabo tega člena, vključno z minimalnimi zahtevami za ta načela se lahko sprejmejo v skladu s postopkom iz člena 76(3) .
Detailed rules for the application of this Article including minimum requirements for these principles may be adopted in accordance with the procedure referred to in Article 76(3) .
Direktiva 2004/35/ES se ne uporablja, če lahko kmet dokaže, da uporablja fitofarmacevtska sredstva v skladu s predpisi, določenimi v tej uredbi, drugi zakonodaji Skupnosti in zakonodaji zadevnih držav članic
Directive 2004/35/CE shall not apply if a farmer can prove proper use of a plant protection product as laid down in this regulation, other Community legislation and the legislation of the Member State concerned.
Okoljska odgovornost se ne bi smela uporabljati za kmete, ki delujejo v skladu z veljavnimi predpisi o uporabi fitofarmacevtskih sredstev.
Environmental liability should not apply to farmers who act according to all the rules in place concerning the use of PPP.
Ne sme se jih obravnavati, kot da ravnajo napačno ali, glede na člen 3, odstavek 1, točka b) Direktive 2004/35/ES, brezbrižno.
They cannot be considered as having been at fault or acting negligently according to Article 3 paragraph 1 point b) of Directive 2004/35/CE.
Informacije o fitofarmacevtskih sredstvih bi morale biti na voljo vsem zadevnim državam članicam.
Information on a plant protection product should be available to all Member States concerned.
Zato imetnik registracije zabeleži vse mogoče škodljive reakcije pri ljudeh , živalih in v okolju , povezane z uporabo fitofarmacevtskega sredstva, in poroča o njih.
To this end the authorisation holder shall record and report all suspected adverse reactions in humans , in animals and the environment related to the use of the plant protection product.
Informacija bi morala vključevati vse mogoče škodljive reakcije pri ljudeh in živalih ter v okolju.
The information should include suspected adverse reactions in humans, animals and the environment.
Zadnji odstavek je črtan, ker je zakonodaja v tretjih državah drugačna, kar otežuje primerjavo uporabe fitofarmacevtskih sredstev v EU.
The last paragraph is deleted since there is different legislation in third countries which makes it difficult to compare the use of plant protection products within the EU.
Člen 53, odstavek 1, pododstavek 4
Article 53, paragraph 1, subparagraph 4
Obveznost obveščanja zajema ustrezne informacije o odločitvah ali ocenah javnih organov, ki registrirajo fitofarmacevtska sredstva ali aktivne snovi v tretjih državah.
The obligation to notify shall include relevant information on decisions or assessments by public bodies which authorise plant protection products or active substances in third countries.
Člen 56, odstavek 1, pododstavek 2, uvodni del
Article 56, paragraph 1, subparagraph 2, introductory part
Varstvo se uporablja za poročila o poskusih in študijah, vključno s povzetki teh poskusov in študij, ki jih je državi članici predložil vlagatelj registracije v skladu s to uredbo (v nadaljnjem besedilu „prvi vlagatelj“), če so bila ta poročila o poskusih in študijah
The protection applies to test and study reports, including summaries of those test and study reports, submitted to a Member State by an applicant for authorisation under this Regulation (hereinafter called ‘the first applicant’), provided that those test and study reports were
Varstvo podatkov bi bilo treba odobriti tudi za informacije, ki jih zberejo pristojni organi v postopkih podaljševanja in pregledov.
Data protection should also be granted to information gathered by authorities in renewal and review procedures.
Varstvo podatkov bi moralo veljati za vse pomembne podatke, ne samo za tiste, pridobljene z dobro laboratorijsko ali okoljsko prakso.
Data protection should cover all relevant data, not only those generated according to GLP or GEP.
Člen 56, odstavek 1, pododstavek 2, točka (a)
Article 56, paragraph 1, subparagraph 2, point (a)
(a) potrebna za registracijo ali spremembo registracije , da se odobri uporaba drugega pridelka, in
(a) necessary for the authorisation or an amendment of an authorisation in order to allow the use on another crop, and
(a) potrebna za registracijo ali spremembo pogojev registracije .
(a) necessary for the authorisation or an amendment of the conditions of an authorisation.
Člen 56, odstavek 1, pododstavek 2, točka (b)
Article 56, paragraph 1, subparagraph 2, point (b)
Glej obrazložitev k členu 56, odstavek 1, pododstavek 2, uvod.
See justification for Article 56, paragraph 1, subparagraph 2, introduction
Člen 56, odstavek 1, pododstavek 3
Article 56, paragraph 1, subparagraph 3
Če je poročilo , vključno z njegovim povzetkom, zaščiteno, ga nobena država članica, ki ga je prejela, ne sme uporabljati v korist drugih vlagateljev za fitofarmacevtska sredstva, razen v skladu z določbami iz člena 59(2) ali člena 77.
Where a report, including a summary thereof, is protected, it may not be used, by any Member State which received it, for the benefit of other applicants for plant protection products, except as provided in paragraph 2, in Article 59 or in Article 77.
Študija, vključno z njenim povzetkom, je zaščitena tudi , če je bila potrebna le za podaljšanje ali pregled registracije.
A study , including a summary thereof, shall also be protected if it was only necessary for the renewal or review of an authorisation.
Varstvo podatkov velja za obdobje pet let.
The period for data protection shall be five years.
Pododstavki od 1 do 4 se uporabljajo smiselno.
The first to fourth subparagraphs shall apply mutandis mutandis.
Varstvo podatkov velja tudi za tretje strani, ki poročila o poskusih in študijah predložijo za uporabo v manjši meri.
Data protection shall also apply to third parties who submit tests and study reports for the purpose of minor uses.
Obdobja varstva podatkov se lahko podaljšajo v skladu s členom 49(4c).
Data protection periods may be extended in accordance with Article 49(4c).
Zaščititi je treba tudi podatke iz postopkov uporabe v manjši meri.
Data provided in minor use procedures needs to be protected as well.
Varstvo podatkov v skladu z odstavkom 1 se odobri le, če je prvi vlagatelj predložil zahtevo v zvezi z varstvom podatkov ob predložitvi dokumentacije ali ob predložitvi dodatnih informacij, na primer o varovalih in sinergistih, in zadevni državi članici za vsako poročilo o poskusih ali študijah predložil:
Data protection under paragraph 1 shall only be granted where the first applicant has claimed data protection at the time of submitting the dossier or when submitting additional information, for example. on safeners and synergists, and has provided to the Member State concerned for each test or study report the following information:
Glej obrazložitev k členu 56, odstavek 1.
See justification for Article 56 paragraph 1.
(a) utemeljitev, da so predložena poročila o poskusih in študijah potrebna za prvo registracijo, podaljšanje ali pregled ali spremembo registracije fitofarmacevtskega sredstva, ali zaradi spremenjene zakonodaje ;
(a) justification that the test and study reports submitted are necessary for the first authorisation, renewal or review, or for the amendment of the authorisation of a plant protection product; or as a result of changes to legislation ;