natgillin/translations-raw huggingface dataset:
it does not contain a substance of concern;
ne vsebuje problematične snovi;
it is sufficiently effective;
je dovolj učinkovito;
it does not cause unnecessary pain and suffering to vertebrates to be controlled;
ne povzroča nepotrebnih bolečin in trpljenja vretenčarjem, zatiranju katerih je namenjeno;
it complies with points (b), (c) and (f) to (i) of Article 29(1).
je v skladu s členom 29(1)(b), (c) in (f) do (i).
These products are referred to as ‘low-risk plant protection products’.
Ta sredstva so v nadaljnjem besedilu „fitofarmacevtska sredstva z majhnim tveganjem“.
An applicant for authorisation of a low-risk plant protection product shall demonstrate that the requirements set out in paragraph 1 are met and shall submit with the application a complete and a summary dossier for each point of the data requirements of the active substance and the plant protection product.
Vlagatelj za registracijo fitofarmacevtskega sredstva z majhnim tveganjem dokaže, da so zahteve iz odstavka 1 izpolnjene, in k vlogi priloži popolno dokumentacijo in njen povzetek za vsako točko zahtev po podatkih o aktivni snovi in fitofarmacevtskem sredstvu.
The Member State shall decide within 120 days whether to approve an application for authorisation of a low-risk plant protection product.
Država članica v 120 dneh sprejme odločitev o odobritvi vloge za registracijo fitofarmacevtskega sredstva z majhnim tveganjem.
Where the Member State needs additional information, it shall set a time limit for the applicant to supply it.
Če država članica potrebuje dodatne informacije, določi rok, v katerem jih mora vlagatelj predložiti.
In that case, the period specified shall be extended by the additional time limit granted by the Member State.
V tem primeru se predpisano obdobje podaljša za dodatno časovno obdobje, ki ga odobri država članica.
The additional period shall be of a maximum of 6 months and shall cease at the moment when the additional information is received by the Member State.
Dodatno obdobje ni daljše od šestih mesecev in preneha, ko država članica prejme dodatne informacije.
Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.
Če ni drugače določeno, se uporabljajo vse določbe v zvezi z registracijami v skladu s to uredbo.
Placing on the market and use of plant protection products containing a genetically modified organism
Dajanje v promet in uporaba fitofarmacevtskih sredstev, ki vsebujejo gensko spremenjeni organizem
A plant protection product which contains an organism falling within the scope of Directive 2001/18/EC shall be examined in respect of the genetic modification in accordance with that Directive, in addition to the assessment under this Chapter.
Fitofarmacevtsko sredstvo, ki vsebuje organizem, ki sodi na področje uporabe Direktive 2001/18/ES, se preuči v zvezi z genskimi spremembami v skladu z zadevno direktivo, poleg ocene v skladu s tem poglavjem.
An authorisation under this Regulation shall not be granted for such a plant protection product unless written consent, as referred to in Article 19 of Directive 2001/18/EC, has been granted for it.
Registracija v skladu s to uredbo se za takšno fitofarmacevtsko sredstvo ne izda, razen če zanj ni bilo izdano pisno dovoljenje iz člena 19 Direktive 2001/18/ES.
Placing on the market of treated seeds
Dajanje v promet tretiranega semena
Member States shall not prohibit placing on the market and use of seeds treated with plant protection products authorised for that use in at least one Member State.
Države članice ne prepovejo dajanje v promet in uporabo semen, tretiranih s fitofarmacevtskimi sredstvi, registriranimi za to uporabo v vsaj eni državi članici.
Where there are substantial concerns that treated seeds as referred to in paragraph 1 are likely to constitute a serious risk to human or animal health or to the environment and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, measures to restrict or prohibit the use and/or sale of such treated seeds shall be taken immediately in accordance with the regulatory procedure referred to in Article 79(3).
V primeru utemeljenih pomislekov, da tretirana semena iz odstavka 1 verjetno resno ogrožajo zdravje ljudi ali živali ali okolje in da tega tveganja ni mogoče preprečiti v zadostni meri z ukrepi, ki jih je sprejela zadevna država članica ali so jih sprejele zadevne države članice, se v skladu z regulativnim postopkom iz člena 79(3) nemudoma izvedejo ukrepi za omejitev ali prepoved uporabe in/ali prodaje teh tretiranih semen.
Before taking such measures the Commission shall examine the evidence and may request an opinion from the Authority.
Pred izvedbo teh ukrepov Komisija preuči dokaze in lahko zahteva mnenje Agencije.
The Commission may set a time limit within which such an opinion shall be provided.
Komisija lahko določi rok, do katerega se to mnenje predloži.
Articles 70 and 71 shall apply.
Uporabljata se člena 70 in 71.
Without prejudice to other Community legislation concerning the labelling of seeds, the label and documents accompanying the treated seeds shall include the name of the plant protection product with which the seeds were treated, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Directive 1999/45/EC and risk mitigation measures set out in the authorisation for that product where appropriate.
Brez poseganja v drugo zakonodajo Skupnosti o označevanju semen, etikete in dokumenti, ki spremljajo tretirana semena vsebujejo ime fitofarmacevtskega sredstva, s katerim je bilo seme tretirano, ime aktivne snovi oziroma aktivnih snovi v tem sredstvu, standardne obvestilne stavke, kot je določeno v Direktivi 1999/45/ES, in, kjer je to primerno, ukrepe za zmanjševanje tveganja, določene v registraciji tega sredstva.
Comparative assessment of plant protection products containing candidates for substitution
Primerjalna ocena fitofarmacevtskih sredstev, ki vsebujejo kandidatke za zamenjavo
A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product containing an active substance approved as a candidate for substitution.
Primerjalno oceno izvedejo države članice, kadar ocenjujejo vlogo za registracijo fitofarmacevtskega sredstva, ki vsebuje aktivno snov, odobreno kot kandidatno snov za zamenjavo.
Member States shall not authorise or shall restrict the use of a plant protection product containing a candidate for substitution for use on a particular crop where the comparative assessment weighing up the risks and benefits, as set out in Annex IV, demonstrates that:
Države članice ne registrirajo fitofarmacevtskega sredstva, ki vsebuje kandidatno snov za zamenjavo, ali omejijo njegovo uporabo pri zadevnih kulturnih rastlinah, če primerjalna ocena, ki preuči tveganja in koristi, kot je določeno v Prilogi IV, pokaže, da:
for the uses specified in the application an authorised plant protection product, or a non-chemical control or prevention method, already exists which is significantly safer for human or animal health or the environment;
za načine uporabe, navedene v vlogi, že obstaja registrirano fitofarmacevtsko sredstvo ali ne-kemična kontrolna ali preventivna metoda, ki je bistveno varnejša za zdravje ljudi ali živali ali za okolje; ter
the substitution by plant protection products or non-chemical control or prevention methods referred to in point (a) does not present significant economic or practical disadvantages;
nadomestitev s fitofarmacevtskimi sredstvi ali ne-kemičnimi kontrolnimi ali preventivnimi metodami iz točke (a) ne pomeni bistvene gospodarske ali praktične izgube; ter
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; and
so kemijska raznolikost aktivnih snovi, če je potrebno, ali metode in prakse pridelave kulturnih rastlin in zatiranja škodljivih organizmov ustrezne za zmanjšanje nastanka odpornosti v ciljnem organizmu; ter
the consequences on minor use authorisations are taken into account.
se upoštevajo posledice na registracije manjših uporab.
By way of derogation from Article 36(2) Member States may in exceptional cases also apply the provisions of paragraph 1 of this Article when evaluating an application for authorisation of a plant protection product not containing a candidate for substitution or a low-risk active substance, if a non-chemical control or prevention method exists for the same use and it is in general use in that Member State.
Z odstopanjem od člena 36(2) lahko države članice pri ocenjevanju vloge za registracijo fitofarmacevtskega sredstva, ki ne vsebuje kandidatne snovi za zamenjavo ali snovi z majhnim tveganjem, izjemoma uporabijo določbe iz odstavka 1 tega člena, če ne-kemična kontrolna ali preventivna metoda obstaja za isto uporabo in se v tej državi članici splošno uporablja.
By way of derogation from paragraph 1, a plant protection product containing a candidate for substitution shall be authorised without comparative assessment in cases where it is necessary to acquire experience first through using that product in practice.
Z odstopanjem od odstavka 1 se fitofarmacevtsko sredstvo, ki vsebuje kandidatno snov za zamenjavo, registrira brez primerjalne ocene, kadar je treba najprej pridobiti izkušnje z uporabo tega sredstva v praksi.
Such authorisations shall be granted once for a period not exceeding five years.
Takšne registracije se izdajo enkrat za največ pet let.
For plant protection products containing a candidate for substitution Member States shall perform the comparative assessment provided for in paragraph 1 regularly and at the latest at renewal or amendment of the authorisation.
Za fitofarmacevtska sredstva, ki vsebujejo kandidatno snov za zamenjavo, države članice redno izvajajo primerjalno oceno, določeno v odstavku 1, najpozneje ob podaljšanju ali spremembi registracije.
Based on the results of that comparative assessment, Member States shall maintain, withdraw or amend the authorisation.
Na podlagi rezultatov te primerjalne ocene države članice registracijo potrdijo, prekličejo ali spremenijo.
Where a Member State decides to withdraw or amend an authorisation pursuant to paragraph 4, that withdrawal or amendment shall take effect 3 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 odloči za preklic ali spremembo registracije v skladu z odstavkom 4, začne zadevni preklic ali sprememba veljati tri leta po odločitvi države članice ali na koncu obdobja odobritve kandidatne snovi za zamenjavo, če se to obdobje konča prej.
Extension of authorisations for minor uses
Razširitev registracij za manjše uporabe
The authorisation holder, official or scientific bodies involved in agricultural activities, professional agricultural organisations or 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.
Imetnik registracije, uradni ali znanstveni organi, ki sodelujejo v kmetijskih dejavnostih, profesionalne kmetijske organizacije ali profesionalni uporabniki lahko zaprosijo za razširitev registracije fitofarmacevtskega sredstva, ki je že registrirano v zadevni državi članici, na manjše uporabe, ki jih registracija še ne vključuje.
Member States shall extend the authorisation provided that:
Države članice razširijo registracijo, če:
the intended use is minor in nature;
je predvidena uporaba po naravi manjša;
the conditions referred to in points (b), (d) and (e) of Article 4(3) and Article 29(1)(i) are satisfied;
so pogoji iz člena 4(3)(b), (d) in (e) ter člena 29(1)(i) izpolnjeni;
the extension is in the public interest; and
je razširitev v javnem interesu; ter
the documentation and information to support the extension of use has been submitted by the persons or bodies referred to in paragraph 1, especially data on the magnitude of residues and where necessary on the risk assessment to the operator, worker and bystander.
so osebe ali organi iz odstavka 1 predložili dokumentacijo in informacije v podporo razširitvi uporabe, zlasti podatke o količini ostankov in po potrebi o oceni tveganja za izvajalce, delavce in druge navzoče.
Member States may take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products to minor uses.
Države članice lahko sprejmejo ukrepe, s katerimi olajšajo ali spodbujajo vlaganje zahtevkov za razširitev registracije že registriranih fitofarmacevtskih sredstev za manjše uporabe.
The extension may take the form of an amendment to the existing authorisation or may be a separate authorisation, in accordance with the administrative procedures of the Member State concerned.
Razširitev je lahko v obliki spremembe obstoječe registracije ali je lahko ločena registracija, v skladu z upravnimi postopki zadevne države članice.
When Member States grant an extension of authorisation for a minor use, they shall inform if necessary the authorisation holder and request him to change the labelling accordingly.
Če države članice odobrijo razširitev registracije na manjše uporabe, o tem po potrebi obvestijo imetnika registracije in ga prosijo, da v skladu s tem spremeni etiketo.
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.
Če imetnik registracije to odkloni, države članice zagotovijo, da so uporabniki polno in natančno obveščeni o navodilih za uporabo, ki se uradno objavijo ali so na voljo na uradni spletni strani.
The official publication or where applicable the label shall include a reference to the liability of the person using the plant protection product with respect to failures concerning the efficacy or to phytotoxicity of the product for which the minor use was granted.
Uradna objava ali, kjer je primerno, etiketa vsebuje navedbo odgovornosti osebe, ki uporablja fitofarmacevtsko sredstvo, glede učinkovitosti ali fitotoksičnosti sredstva, za katero je bila odobrena manjša uporaba.
The minor use extension shall be separately identified in the label.
Razširitev na manjšo uporabo je na etiketi navedena ločeno.
Extensions on the basis of this Article shall be separately identified and separate reference shall be made to liability restrictions.
Razširitve na podlagi tega člena se ločeno opredeli in ločeno navede omejitev odgovornosti.
The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) provided that a plant protection product concerned is authorised in that Member State.
Vlagatelji iz odstavka 1 lahko prav tako zaprosijo za registracijo fitofarmacevtskega sredstva za manjše uporabe v skladu s členom 40(1), če je fitofarmacevtsko sredstvo v tej državi članici registrirano.
Member States shall authorise such uses in accordance with the provisions of Article 41 provided that those uses are also considered minor in the Member States of application.
Države članice registrirajo navedene vrste uporabe v skladu z določbami člena 41 pod pogojem, da te štejejo za manjše uporabe tudi v državah članicah vloženega zahtevka.
Member States shall establish and regularly update a list of minor uses.
Države članice sestavijo in redno posodabljajo seznam manjših uporab.
By 14 December 2011, the Commission shall present a report to the European Parliament and the Council on the establishment of a European fund for minor uses, accompanied, if appropriate, by a legislative proposal.
Komisija Evropskemu parlamentu in Svetu najpozneje do 14. decembra 2011 predloži poročilo o ustanovitvi evropskega sklada za manjše uporabe in po potrebi poda zakonodajni predlog.
Parallel trade
Vzporedno trgovanje
A plant protection product that is authorised in one Member State (Member State of origin) may, subject to granting a parallel trade permit, be introduced, placed on the market or used in another Member State (Member State of introduction), if this Member State determines that the plant protection product is identical in composition to a plant protection product already authorised in its territory (reference product).
Fitofarmacevtsko sredstvo, registrirano v eni državi članici (država članica izvora), se lahko ob odobritvi dovoljenja za vzporedno trgovanje vnese, da v promet ali uporablja v drugi državi članici (država članica vnosa), če ta država članica določi, da je fitofarmacevtsko sredstvo po sestavi identično fitofarmacevtskemu sredstvu, ki je bilo na njenem območju že registrirano (referenčno sredstvo).
The application shall be submitted to the competent authority of the Member State of introduction.
Vloga se predloži pristojnemu organu v državi članici vnosa.
From receiving a complete application, a parallel trade permit shall be granted in a simplified procedure within 45 working days if the plant protection product to be introduced is identical in terms of paragraph 3.
Po prejemu popolne vloge se dovoljenje za vzporedno trgovanje izda v poenostavljenem postopku v 45 delovnih dneh, če je fitofarmacevtsko sredstvo, ki se bo vneslo, identično v skladu z odstavkom 3.
Member States shall on request provide each other with the information necessary to assess whether the products are identical within 10 working days of receiving the request.
Države članice na zahtevo druga drugi zagotovijo podatke, potrebne za oceno, ali gre za identična sredstva, v roku 10 delovnih dni po prejetju vloge.
The procedure for granting a parallel trade permit is interrupted from the day the request for information is sent to the competent authority of the Member State of origin until the complete information required is delivered to the competent authority of the Member State of introduction.
Postopek za izdajo dovoljenja za vzporedno trgovanje se prekine od dne, ko je bila pristojnemu organu v državi članici izvora poslana zahteva za podatke, do dne, ko so bili zahtevani podatki v celoti dostavljeni pristojnemu organu.
Plant protection products shall be considered as identical to the reference products if:
Šteje se, da so fitofarmacevtska sredstva identična referenčnim sredstvom, če:
they have been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process;
jih je proizvedla ista družba ali povezano podjetje ali so bili proizvedeni v okviru licence v skladu z istim proizvodnim postopkom;
they are identical in specification and content to the active substances, safeners and synergists, and in the type of formulation; and
so identična po specifikaciji in vsebini aktivnih snovi, varoval in sinergistov ter po vrsti formulacije; ter
they are either the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
so enaka ali ekvivalentna glede vsebovanih dodatkov in velikosti, materiala ali oblike embalaže v smislu možnega škodljivega vpliva na varnost izdelka za zdravje ljudi ali živali ali za okolje.
The application for a parallel trade permit shall include the following information:
V vlogi za dovoljenje za vzporedno trgovanje se navedejo naslednje informacije:
the name and registration number of the plant protection product in the Member State of origin;
ime in številka registracije fitofarmacevtskega sredstva v državi članici izvora;
the Member State of origin;
država članica izvora;
the name and address of the authorisation holder in the Member State of origin;
ime in priimek ter naslov imetnika registracije v državi članici izvora;
the original label and instructions for use with which the plant protection product to be introduced is distributed in the Member State of origin if it is considered as necessary for the examination by the competent authority of the Member State of introduction.
izvirna etiketa in izvirna navodila za uporabo, skupaj s katerimi se fitofarmacevtsko sredstvo, ki naj bi se vneslo, distribuira v državi članici izvora, če se šteje, da je potrebno, da jih pristojni organ države članice vnosa preuči.
This competent authority may require a translation of the relevant parts of the original instructions for use;
Pristojni organ lahko zahteva prevod ustreznih delov izvirnih navodil za uporabo;
the name and address of the applicant;
ime in priimek ter naslov vlagatelja;
the name to be given to the plant protection product to be distributed in the Member State of introduction;
ime fitofarmacevtskega sredstva, ki naj bi se distribuiralo v državi članici vnosa;
a draft label for the product intended to be placed on the market;
osnutek etikete sredstva, ki naj bi ga dali v promet;
a sample of the product which is intended to be introduced if it is considered as necessary by the competent authority of the Member State of introduction;
vzorec sredstva, ki naj bi se vneslo, če pristojni organ države članice vnosa meni, da je to potrebno.
the name and registration number of the reference product.
ime in številko registracije referenčnega sredstva.
The information requirements may be amended or completed and further details and specific requirements shall be established in cases of application for a plant protection product for which a parallel trade permit has already been granted and in cases of an application for a plant protection product for a personal use in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
Zahteve po podatkih se lahko v primeru vloge za fitofarmacevtsko sredstvo, za katero je bilo dovoljenje za vzporedno trgovanje že odobreno, in v primeru vloge za fitofarmacevtsko sredstvo za osebno uporabo spremenijo ali dopolnijo ter določijo dodatne podrobnosti in specifične zahteve v skladu z regulativnim postopkom s pregledom iz člena 79(4).
A plant protection product for which a parallel trade permit has been issued shall be placed on the market and used only in accordance with the provisions of the authorisation of the reference product.
Fitofarmacevtsko sredstvo, za katerega je bilo izdano dovoljenje za vzporedno trgovanje, se da v promet in uporablja samo v skladu z določbami registracije referenčnega sredstva.
To facilitate monitoring and controls the Commission shall set out specific control requirements for the product to be introduced in a Regulation referred to in Article 68.
Komisija zaradi lažjega spremljanja in nadzora z uredbo iz člena 68 določi zahteve za nadzor sredstva, ki se bo vneslo.
The parallel trade permit shall be valid for the duration of authorisation of the reference product.
Dovoljenje za vzporedno trgovanje je veljavno do poteka registracije referenčnega sredstva.
If the authorisation holder of the reference product applies for a withdrawal of authorisation in accordance with Article 45(1) and the requirements of Article 29 are still fulfilled, the validity of the parallel trade permit shall expire by the date on which the authorisation of the reference product would normally have expired.
Če imetnik registracije referenčnega sredstva zahteva preklic registracije v skladu s členom 45(1) in so zahteve iz člena 29 še vedno izpolnjene, veljavnost dovoljenja za vzporedno trgovanje poteče na dan, ko bi registracija referenčnega sredstva normalno potekla.
Without prejudice to specific provisions of this Article, Articles 44, 45, 46, and 55 and Article 56(4) and Chapters VI to X shall apply to parallel traded plant protection products correspondingly.
Brez poseganja v posebne določbe tega člena se členi 44, 45, 46 in 55 ter člen 56(4) in poglavja VI do X ustrezno uporabljajo za fitofarmacevtska sredstva, s katerimi se vzporedno trguje.