natgillin/translations-raw huggingface dataset:
Without prejudice to Article 44, a parallel trade permit may be withdrawn if the authorisation of the introduced plant protection product is withdrawn in the Member State of origin because of safety or efficacy reasons.
Brez poseganja v člen 44 se dovoljenje za vzporedno trgovanje lahko prekliče, če se zaradi varnosti ali učinkovitosti v državi članici izvora prekliče registracija vnesenega fitofarmacevtskega sredstva.
Where the product is not identical, in terms of paragraph 3, to the reference product, the Member State of introduction may only grant the authorisation required for placing on the market and use in accordance with Article 29.
Če sredstvo v smislu odstavka 3 ni identično referenčnemu sredstvu, lahko država članica vnosa izda le registracijo, ki je potrebna za dajanje v promet in uporabo v skladu s členom 29.
The provisions of this Article shall not apply to plant protection products which are authorised in the Member State of origin in accordance with Article 53 or 54.
Določbe tega člena se ne uporabljajo za fitofarmacevtska sredstva, ki so registrirana v državi članici izvora v skladu s členom 53 ali 54.
Without prejudice to Article 63, Member State authorities shall make publicly available information about parallel trade permits.
Organi države članice brez poseganja v člen 63 objavijo informacije o dovoljenjih za vzporedno trgovino.
Emergency situations in plant protection
Nujni primeri v zvezi z varstvom rastlin
By way of derogation from Article 28, in special circumstances a Member State may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means.
Z odstopanjem od člena 28 lahko država članica v posebnih okoliščinah za obdobje največ 120 dni dovoli dajanje v promet fitofarmacevtskih sredstev za omejeno in nadzorovano uporabo, če je ta ukrep potreben zaradi nevarnosti, ki je ni mogoče obvladati z drugimi ustreznimi ukrepi.
The Member State concerned shall immediately inform the other Member States and the Commission of the measure taken, providing detailed information about the situation and any measures taken to ensure consumer safety.
Zadevna država članica takoj obvesti druge države članice in Komisijo o sprejetih ukrepih, vključno s podrobnimi informacijami o položaju in ukrepih, sprejetih za zagotovitev varstva potrošnikov.
The Commission may ask the Authority for an opinion, or for scientific or technical assistance.
Komisija lahko Agencijo prosi za mnenje ali znanstveno ali tehnično pomoč.
The Authority shall provide its opinion or the results of its work to the Commission within 1 month of the date of the request.
Agencija svoje mnenje ali rezultate svojega dela Komisiji zagotovi v enem mesecu od datuma predložitve zahteve.
If necessary, a decision shall be taken, in accordance with the regulatory procedure referred to in Article 79(3), as to when and under what conditions the Member State:
Če je potrebno, se v skladu z regulativnim postopkom iz člena 79(3) sprejme odločitev o tem, če in pod kakšnimi pogoji država članica:
may or may not extend the duration of the measure or repeat it; or
sme ali ne sme podaljšati ali ponoviti ukrepa; ali
shall withdraw or amend its measure.
prekliče ali spremeni svoj ukrep.
Paragraphs 1 to 3 shall not apply to plant protection products containing or composed of genetically modified organisms unless such release has been accepted in accordance with Directive 2001/18/EC.
Odstavki 1 do 3 se ne uporabljajo za fitofarmacevtska sredstva, ki vsebujejo gensko spremenjene organizme ali so sestavljena iz njih, razen če je bila takšna sprostitev sprejeta v skladu z Direktivo 2001/18/ES.
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 or involving unauthorised use of a 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 permit for trial purposes.
Z odstopanjem od člena 28 se preskusi ali testi za raziskovalne in razvojne namene, ki vključujejo izpust neregistriranega fitofarmacevtskega sredstva v okolje ali vključujejo nedovoljeno uporabo fitofarmacevtskih sredstev, lahko izvajajo, če je država članica, v kateri se izvaja preskus ali test, ocenila razpoložljive podatke in izdala dovoljenje za preskusne namene.
The permit 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.
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 (ES) št. 396/2005 že uveljavljena ustrezna določba.
The Member State may authorise a programme of experiments or tests in advance or require a permit for each experiment or test.
Država članica lahko odobri program preskusov ali testov vnaprej ali zahteva dovoljenje za vsak preskus ali test.
An application shall be submitted to the Member State in whose territory the experiment or test is to be conducted, together with a dossier containing all the available data to permit an assessment of possible effects on human or animal health or the possible impact on the environment.
Vloga se predloži državi članici, v kateri se izvaja preskus ali test, vključno z dokumentacijo, ki vsebuje vse razpoložljive podatke, za odobritev ocene možnih posledic za zdravje ljudi ali živali ali možen vpliv na okolje.
A permit for trial purposes shall not be granted for experiments or tests involving the release into the environment of a genetically modified organism unless such release has been accepted under Directive 2001/18/EC.
Dovoljenje v preskusne namene se ne izda za preskuse ali teste, ki vključujejo izpust gensko spremenjenih organizmov v okolje, razen če je bil ta izpust sprejet v skladu z Direktivo 2001/18/ES.
Paragraph 2 shall not apply if the Member State has granted the person concerned the right to undertake certain experiments and tests and has determined the conditions under which the experiments and tests have to be undertaken.
Odstavek 2 se ne uporablja, če je država članica zadevni osebi dala pravico do opravljanja nekaterih poskusov in testov ter določila pogoje, v katerih je preskuse in teste treba opraviti.
Detailed rules for the implementation of this Article, in particular the maximum quantities of plant protection products that may be released during experiments or tests and the minimum data to be submitted in accordance with paragraph 2, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
Podrobna pravila za izvajanje tega člena, zlasti največje količine fitofarmacevtskih sredstev, ki se lahko sproščajo med preskusi ali testi, ter najmanjše število podatkov, ki jih je treba predložiti v skladu z odstavkom 2, se lahko sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 79(4).
Use and information
Uporaba in informacije
Use of plant protection products
Uporaba fitofarmacevtskih sredstev
Plant protection products shall be used properly.
Fitofarmacevtska sredstva se pravilno uporabljajo.
Proper use shall include the application of the principles of good plant protection practice and compliance with the conditions established in accordance with Article 31 and specified on the labelling.
Pravilna uporaba vključuje uporabo načel dobre prakse varstva rastlin in skladnost s pogoji iz člena 31, ki so navedeni na etiketi.
It shall also comply with the provisions of Directive 2009/128/EC and, in particular, with general principles of integrated pest management, as referred to in Article 14 of and Annex III to that Directive, which shall apply at the latest by 1 January 2014.
Sklada se tudi z določili Direktive 2009/128/ES in zlasti s splošnimi načeli integriranega varstva rastlin pred škodljivimi organizmi, kot je določeno v členu 13 in Prilogi III k navedeni direktivi, ki se začne uporabljati najpozneje s 1. januarjem 2014.
Information on potentially harmful or unacceptable effects
Informacije o možnih škodljivih ali nesprejemljivih vplivih
The holder of an authorisation for a plant protection product shall immediately notify the Member States that granted an authorisation of any new information concerning that plant protection product, the active substance, its metabolites, a safener, synergist or co-formulant contained in the plant protection product, which suggests that the plant protection product no longer complies with the criteria set out in Articles 29 and 4 respectively.
Imetnik registracije za fitofarmacevtsko sredstvo takoj obvesti države članice, ki so izdale registracijo, o kakršnih koli novih informacijah v zvezi s fitofarmacevtskim sredstvom, aktivno snovjo, metaboliti, varovalom, sinergistom ali dodatki, ki jih vsebuje fitofarmacevtsko sredstvo, iz katerih je razvidno, da fitofarmacevtsko sredstvo ne izpolnjuje več meril iz člena 29 oziroma 4.
In particular, potentially harmful effects of that plant protection product, or of residues of an active substance, its metabolites, a safener, synergist or co-formulant contained in it, on human or animal health or on groundwater, or their potentially unacceptable effects on plants or plant products or the environment shall be notified.
Zlasti je pomembno obvestilo o možnih škodljivih učinkih tega fitofarmacevtskega sredstva ali ostankov aktivne snovi, metabolitov, varovala, sinergista ali dodatka, ki jih vsebuje, na zdravje ljudi ali živali ali na podzemno vodo, ali njihovih možnih nesprejemljivih učinkih na rastline ali rastlinske proizvode ali okolje.
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.
Zato imetnik registracije zabeleži vse mogoče škodljive reakcije pri ljudeh, živalih in v okolju, povezane z uporabo fitofarmacevtskega sredstva, in poroča o njih.
The obligation to notify shall include relevant information on decisions or assessments by international organisations or by public bodies which authorise plant protection products or active substances in third countries.
Obveznost uradnega obveščanja zajema ustrezne informacije o odločitvah ali ocenah mednarodnih organizacij in javnih organov, ki registrirajo fitofarmacevtska sredstva ali aktivne snovi v tretjih državah.
The notification shall include an assessment of whether and how the new information would result in the plant protection product or the active substance, its metabolites, a safener, or synergist or co-formulant no longer complying with the requirements set out in Article 29 and Article 4 or Article 27, respectively.
Uradno obvestilo zajema oceno o tem, ali in kako nove informacije povzročijo, da fitofarmacevtsko sredstvo ali aktivna snov, metaboliti, varovalo, sinergist ali dodatek niso več v skladu z zahtevami iz člena 29 in člena 4 oziroma 27.
Without prejudice to the right of Member States to adopt interim protective measures, the Member State which first granted an authorisation within each zone shall evaluate the information received and inform the other Member States, belonging to the same zone, where it decides to withdraw or amend the authorisation under Article 44.
Brez poseganja v pravico držav članic, da sprejmejo začasne varnostne ukrepe, država članica, ki je prva izdala registracijo v vsaki coni, oceni prejete informacije in obvesti druge države članice, ki sodijo v isto cono, kjer se odloči za preklic ali spremembo registracije v skladu s členom 44.
That Member State shall inform the other Member States and the Commission where it considers that the conditions of the approval of the active substance, safener or synergist contained in the plant protection product are no longer fulfilled or whether in the case of a co-formulant it has been considered unacceptable and propose that the approval be withdrawn or the conditions amended.
Ta država članica obvesti druge države članice in Komisijo, če meni, da pogoji za odobritev aktivne snovi, varovala, sinergista v fitofarmacevtskem sredstvu niso izpolnjeni – ali, v primeru dodatka, štejejo za nesprejemljive – in predlaga, da se prekliče registracija ali spremenijo pogoji.
The holder of an authorisation for a plant protection product shall report annually to the competent authorities of the Member States which authorised his plant protection product if he has any information available relating to the lack of expected efficacy, the development of resistance and to any unexpected effect on plants, plant products or the environment.
Imetnik registracije za fitofarmacevtsko sredstvo letno poroča pristojnim organom države članice, ki je registrirala fitofarmacevtsko sredstvo, če ima kakršne koli razpoložljive informacije, povezane s pomanjkanjem pričakovane učinkovitosti, razvojem odpornosti in katerim koli nepričakovanim vplivom na rastline, rastlinske proizvode ali okolje.
Obligation to keep information available
Obveznost dajanja informacij na voljo
Member States shall keep information electronically available to the public on plant protection products authorised or withdrawn in accordance with this Regulation, containing at least:
Države članice dajejo javnosti na voljo v elektronski obliki informacije o fitofarmacevtskih sredstvih, registriranih ali preklicanih v skladu s to uredbo, ki vključujejo vsaj:
the name or business name of the holder of the authorisation and the authorisation number;
ime ali naziv podjetja imetnika registracije in številko registracije;
the trade name of the product;
trgovsko ime sredstva;
the type of preparation;
vrsto pripravka;
the name and amount of each active substance, safener or synergist which it contains;
ime in količino vseh aktivnih snovi, varoval ali sinergistov, ki jih vsebuje;
the classification, risk and safety phrases in accordance to Directive 1999/45/EC and to the Regulation referred to in Article 65;
razvrstitev, opozorilne in obvestilne stavke v skladu z Direktivo 1999/45/ES in uredbo, omenjeno v členu 65;
the use or uses for which it is authorised;
uporabo ali več vrst uporabe, za katere je registrirano;
the reasons for withdrawal of an authorisation if they are related to safety concerns;
razloge za preklic registracije, če so povezani s skrbjo za varnost;
the list of minor uses referred to in Article 51(8).
seznam manjših uporab iz člena 51(8).
The information referred to in paragraph 1 shall be readily accessible and updated at least once every 3 months.
Informacije iz odstavka 1 so zlahka dostopne in posodobljene najmanj enkrat na tri mesece.
In accordance with the regulatory procedure referred to in Article 79(3), an authorisation information system may be set up to facilitate the application of paragraphs 1 and 2 of this Article.
V skladu z regulativnim postopkom iz člena 79(3) se lahko za lažjo uporabo odstavkov 1 in 2 tega člena vzpostavi informacijski sistem za registracije.
ADJUVANTS
POMOŽNA SREDSTVA
Placing on the market and use of adjuvants
Dajanje v promet in uporaba pomožnih sredstev
An adjuvant shall not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with the conditions established in the Regulation referred to in paragraph 2.
Pomožno sredstvo se ne da v promet in se ne uporabi, če ga zadevna država članica ni registrirala v skladu s pogoji uredbe iz odstavka 2.
Detailed rules for the authorisation of adjuvants, including data requirements, notification, evaluation, assessment and decision making procedures shall be set out in a Regulation to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
Podrobna pravila za registracijo pomožnih sredstev, tudi zahteve po podatkih, obveščanje, vrednotenje, ocenjevanje in odločanje se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 79(4).
Article 81(3) shall apply.
Uporablja se člen 81(3).
DATA PROTECTION AND DATA SHARING
VARSTVO IN IZMENJAVA PODATKOV
Test and study reports shall benefit from data protection under the conditions laid down in this Article.
Za poročila o preskusih in študijah velja varstvo podatkov v skladu s pogoji iz tega člena.
The protection shall apply to test and study reports concerning the active substance, safener or synergist, adjuvants and the plant protection product as referred to in Article 8(2) when they are submitted to a Member State by an applicant for authorisation under this Regulation, (the first applicant), provided that those test and study reports were:
Varstvo se uporablja za poročila o preskusih in študijah v zvezi z aktivno snovjo, varovalom ali sinergistom, dodatkom in s fitofarmacevtskim sredstvom, kakor je navedeno v členu 8(2), kadar jih državi članici predloži vlagatelj registracije v skladu s to uredbo (prvi vlagatelj), če so bila ta poročila o preskusih in študijah:
necessary for the authorisation or an amendment of an authorisation in order to allow the use on another crop; and
potrebna za registracijo ali spremembo registracije, da se dovoli uporaba na drugem pridelku, in
certified as compliant with the principles of good laboratory practice or of good experimental practice.
potrjena kot skladna z načeli dobre laboratorijske prakse ali dobre preskusne prakse.
Where a report is protected, it may not be used by the Member State which received it for the benefit of other applicants for authorisation of plant protection products, safeners or synergists and adjuvants, except as provided in paragraph 2 of this Article, in Article 62 or in Article 80.
Če je poročilo zaščiteno, ga država članica, ki ga je prejela, ne sme uporabljati v korist drugih vlagateljev za registracijo fitofarmacevtskih sredstev, varoval ali sinergistov in pomožnih sredstev, razen v skladu z odstavkom 2, členom 62 ali členom 80.
The period of data protection is 10 years starting at the date of first authorisation in that Member State, except as provided in paragraph 2 of this Article or in Article 62.
Obdobje varstva podatkov je deset let od datuma prve registracije v zadevni državi članici, razen kot je določeno v odstavku 2 ali v členu 62.
That period is extended to 13 years for plant protection products covered by Article 47.
Za fitofarmacevtska sredstva iz člena 47 se obdobje podaljša na 13 let.
Those periods shall be extended by 3 months for each extension of authorisation for minor uses as defined in Article 51(1), except where the extension of authorisation is based on extrapolation, if the applications for such authorisations are made by the authorisation holder at the latest 5 years after the date of the first authorisation in that Member State.
Ta obdobja se podaljšajo za tri mesece za vsako razširitev registracije na manjšo uporabo, kakor je opredeljeno v členu 51(1), razen če razširitev registracije temelji na ekstrapolaciji, če imetnik registracije vloži vlogo za tako registracijo najpozneje 5 let po datumu prve registracije v zadevni državi članici.
The total period of data protection may in no case exceed 13 years.
Celotno obdobje varstva podatkov ne sme v nobenem primeru biti daljše od 13 let.
For plant protection products covered by Article 47 the total period of data protection may in no case exceed 15 years.
Za fitofarmacevtska sredstva iz člena 47 celotno obdobje varstva podatkov ne sme v nobenem primeru biti daljše od 15 let.
The same data protection rules as for the first authorisation shall also apply to test and study reports submitted by third parties for the purpose of extension of authorisation for minor uses as referred to in Article 51(1).
Ista pravila o varstvu podatkov kot za prvo registracijo se uporabijo tudi za poročila o preskusih in študijah, ki jih predložijo tretje strani za razširitev registracije na manjše uporabe iz člena 51(1).
A study shall also be protected if it was necessary for the renewal or review of an authorisation.
Študija se tudi zaščiti, če je bilo to potrebno za podaljšanje ali pregled registracije.
The period for data protection shall be 30 months.
Obdobje varovanja podatkov je 30 mesecev.
The first to fourth subparagraphs shall apply mutatis mutandis.
Prvi do četrti pododstavek se uporabljajo smiselno.
to test and study reports for which the applicant has submitted a letter of access; or
za poročila o preskusih in študijah, za katere je vlagatelj predložil izjavo o dostopu; ali
where any period of data protection granted for the test and study reports concerned in relation to another plant protection product has expired.
če je poteklo obdobje varstva podatkov, odobreno za zadevna poročila o preskusih in študijah v zvezi z drugim fitofarmacevtskim sredstvom.
Data protection under paragraph 1 shall only be granted where the first applicant has claimed data protection for test and study reports concerning the active substance, safener or synergist, adjuvant and the plant protection product at the time of submitting the dossier and has provided to the Member State concerned for each test or study report the information referred to in point (f) of Article 8(1) and in point (d) of Article 33(3) as well as confirmation that a period of data protection has never been granted for the test or study report or that any period granted has not expired.
Varstvo podatkov iz odstavka 1 se odobri le, kadar prvi vlagatelj predloži zahtevo za varstvo podatkov za poročila o preskusih in študijah v zvezi z aktivno snovjo, varovalom ali sinergistom, pomožnim sredstvom in s fitofarmacevtskim sredstvom istočasno s predložitvijo dokumentacije in zadevni državi članici za vsako poročilo o preskusih ali študijah zagotovi informacije iz členov 8(1)(f) in 33(3)(d) ter potrditev, da obdobje varstva podatkov za poročilo o preskusih in študijah nikoli ni bilo odobreno ali da odobreno obdobje varstva ni poteklo.
List of test and study reports
Seznam poročil o preskusih in študijah
For each active substance, safener and synergist and adjuvant, rapporteur Member States shall prepare a list of the test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval and make it available to the Member States and the Commission.
Država članica poročevalka za vsako aktivno snov, varovalo, sinergist in pomožno sredstvo pripravi seznam poročil o preskusih in študijah, potrebnih za prvo odobritev, spremembo pogojev za odobritev ali podaljšanje odobritve, in ga da na voljo državam članicam in Komisiji.
For each plant protection product which they authorise, Member States shall keep and make available to any interested party upon request:
Na zahtevo katere koli zainteresirane strani dajo države članice za vsako fitofarmacevtsko sredstvo, ki ga registrirajo, hranijo in dajo na voljo:
a list of the test and study reports concerning the active substance, safener or synergist, adjuvant and the plant protection product necessary for first authorisation, amendment of the authorisation conditions or renewal of the authorisation; and
seznam poročil o preskusih in študijah v zvezi z aktivno snovjo, varovalom ali sinergistom, pomožnim sredstvom in fitofarmacevtskim sredstvom, potrebnih za prvo registracijo, spremembo pogojev registracije ali podaljšanje registracije; ter
a list of test and study reports for which the applicant claimed data protection under Article 59 and any reasons submitted in accordance with that Article.
seznam poročil o preskusih in študijah, v zvezi s katerimi je vlagatelj predložil zahtevo za varstvo podatkov v skladu s členom 59, in utemeljitve, predložene v skladu s tem členom.