natgillin/translations-raw huggingface dataset:
Annex IV shall be first established within 12 months from the entry into force of this Regulation.
Priloga IV se prvič sestavi v roku dvanajstih mesecev od začetka veljavnosti te uredbe.
PROCEDURE FOR APPLICATIONS FOR MRLS
POSTOPEK Z VLOGAMI ZA MVO
Submission of applications for MRLs
PREDLOŽITEV VLOG ZA MVO
Applications
Vloge
Where a Member State envisages granting an authorisation or a provisional authorisation for the use of a plant protection product in accordance with Directive 91/414/EEC, that Member State shall consider whether, as a result of such use, an existing MRL set out in Annex II or III to this Regulation needs to be modified, whether it is necessary to set a new MRL, or whether the active substance should be included in Annex IV.
Če država članica namerava registrirati ali začasno registrirati uporabo fitofarmacevtskega proizvoda v skladu z Direktivo 91/414/EGS, ta država članica preuči, ali je kot rezultat te uporabe treba obstoječe MVO, določene v Prilogi II ali III k tej uredbi, spremeniti, določiti novo MVO ali je treba aktivno snov vključiti v Prilogo IV.
If necessary it shall require the party requesting the authorisation to submit an application in accordance with Article 7.
Po potrebi država članica od stranke, ki prosi za registracijo, zahteva predložitev vloge v skladu s členom 7.
All parties demonstrating, through adequate evidence, a legitimate interest in health, including civil society organisations, as well as commercially interested parties such as manufacturers, growers, importers and producers of products covered by Annex I may also submit an application to a Member State in accordance with Article 7.
Vse stranke, ki z ustreznim dokazilom izkažejo legitimni interes za zdravje, vključno z organizacijami civilne družbe in strankami s poslovnim interesom, kot so izdelovalci, pridelovalci, uvozniki in proizvajalci proizvodov iz Priloge I, prav tako lahko državi članici predložijo vlogo v skladu s členom 7.
Where a Member State considers that the setting, modification or deletion of an MRL is necessary, that Member State may also compile and evaluate an application for setting, modifying, or deleting the MRL in accordance with Article 7.
Če država članica meni, da je potrebna določitev, sprememba ali izbris MVO, lahko ta država članica prav tako sestavi in oceni vlogo za določitev, spremembo ali izbris MVO v skladu s členom 7.
Applications for import tolerances shall be submitted to rapporteur Member States designated pursuant to Directive 91/414/EEC or, if no such rapporteur has been designated, applications shall be made to Member States designated by the Commission in accordance with the procedure referred to in Article 45(2) of this Regulation at the request of the applicant.
Vloge za uvozne tolerance se predložijo državi članici poročevalki, imenovani v skladu z Direktivo 91/414/EGS, oziroma, če taka poročevalka ni imenovana, se vloge predložijo državam članicam, ki jih imenuje Komisija na zahtevo vlagatelja v skladu s postopkom iz člena 45(2) te uredbe.
Such applications shall be made in accordance with Article 7 of this Regulation.
Te vloge se predložijo v skladu s členom 7.
Requirements relating to applications for MRLs
Zahteve v zvezi z vlogami za MVO
The applicant shall include in an application for an MRL the following particulars and documents:
Vlagatelj vključi v vlogo za MVO naslednje informacije in dokumente:
the name and address of the applicant;
ime in naslov vlagatelja;
a presentation of the application dossier including:(i) a summary of the application;
predložitev dosjeja z vlogo, ki vključuje:(i) povzetek vloge;
the main substantive arguments;
glavne vsebinske argumente;
an index of the documentation;
kazalo dokumentacije;
a copy of the relevant GAP applying to the specific use of that active substance;
kopijo ustrezne DKP, ki se uporablja za poseben način uporabe te aktivne snovi;
a comprehensive overview of relevant concerns raised in the available scientific literature about the plant protection product and/or its residue;
popoln pregled ustreznih pomislekov v obstoječi znanstveni literaturi o fitofarmacevtskih sredstvih in/ali o njihovih ostankih;
the data listed in Annexes II and III to Directive 91/414/EEC relating to data requirements for the setting of MRLs for pesticides including, where appropriate, toxicological data and data on routine analytical methods for use in control laboratories, as well as plant and animal metabolism data.
podatke, navedene v prilogah II in III k Direktivi 91/414/EGS glede zahtevanih podatkov za določitev MVO za pesticide, vključno, če je to primerno, s toksikološkimi podatki in podatki o rutinskih analiznih metodah za uporabo v nadzornih laboratorijih ter podatki o presnovi rastlin in živali.
However, where relevant data are already publicly available, in particular when an active substance has already been evaluated under Directive 91/414/EEC or when a CXL exists and such data are submitted by the applicant, a Member State may also use such information in evaluating an application.
Če pa so ustrezni podatki že javno dostopni, predvsem če je bila aktivna snov že ocenjena v skladu z Direktivo 91/414/EGS ali če obstaja CXL, in je predlagatelj take podatke predložil, lahko država članica uporabi te informacije za ocenitev vloge.
In such cases, the evaluation report shall include a justification for using or not using such data.
V teh primerih bo ocenjevalno poročilo vključevalo obrazložitev v zvezi z uporabo oziroma neuporabo teh podatkov.
The evaluating Member State may, where appropriate, request the applicant to provide supplementary information in addition to information required under paragraph 1 within a time limit specified by the Member State.
Ocenjujoča država članica lahko, kjer je to primerno, v roku, ki ga določi, zahteva od predlagatelja predložitev dodatnih informacij poleg informacij, zahtevanih v skladu z odstavkom 1.
In no event may this period exceed two years.
V nobenem primeru ta rok ne sme biti daljši od dveh let.
Evaluation of applications
Ocenjevanje vlog
A Member State to which an application complying with Article 7 is submitted pursuant to Article 6 shall immediately forward a copy to the Authority and the Commission and draw up an evaluation report without undue delay.
Država članica, ki ji je v skladu s členom 6 predložena vloga, ki izpolnjuje pogoje iz člena 7, kopijo vloge nemudoma posreduje agenciji in Komisiji ter brez nepotrebnega odlašanja pripravi ocenjevalno poročilo.
Applications shall be evaluated in accordance with the relevant provisions of the Uniform Principles for the Evaluation and Authorisation of Plant Protection Products set out in Annex VI to Directive 91/414/EEC or specific evaluation principles to be laid down in a Commission Regulation in accordance with the procedure referred to in Article 45(2) of this Regulation.
Vloge se ocenijo v skladu z ustreznimi določbami Enotnih načel za ocenjevanje in registracijo fitofarmacevtskih sredstev, določenih v Prilogi VI k Direktivi 91/414/EGS, ali s posebnimi načeli za ocenjevanje, ki se določijo z uredbo Komisije po postopku iz člena 45(2) te uredbe.
By way of derogation from paragraph 1 and by agreement between the Member States concerned, evaluation of the application may be carried out by the rapporteur Member State designated pursuant to Directive 91/414/EEC for that active substance.
Z odstopanjem od odstavka 1 in s soglasjem zadevnih držav članic lahko ocenjevanje vloge izvede država članica poročevalka, imenovana v skladu z Direktivo 91/414/EGS za zadevno aktivno snov.
Where a Member State encounters difficulties in evaluating an application or in order to avoid duplication of work, it may be decided in accordance with the procedure referred to in Article 45(2) which Member State shall evaluate particular applications.
Če ima država članica težave pri ocenjevanju vloge ali v izogib podvajanju dela, se lahko v skladu s postopkom iz člena 45(2) določi, katera država članica bo ocenjevala določene vloge.
Submission of evaluated applications to the Commission and the Authority
Predložitev ocenjenih vlog Komisiji in agenciji
After completion of the evaluation report, the Member State shall forward it to the Commission.
Po dokončanju ocenjevalnega poročila ga država članica posreduje Komisiji.
The Commission shall without delay inform the Member States and forward the application, the evaluation report and the supporting dossier to the Authority.
Komisija brez odlašanja obvesti države članice in agenciji posreduje vlogo, ocenjevalno poročilo in spremljevalni dosje.
The Authority shall acknowledge in writing receipt of the application to the applicant, the evaluating Member State and the Commission without delay.
Agencija brez odlašanja pisno potrdi prejem vloge vlagatelju, ocenjujoči državi članici in Komisiji.
The acknowledgement shall state the date of receipt of the application and the accompanying documents.
Potrdilo navaja datum prejema vloge in spremljajoče dokumente.
Consideration of applications concerning MRLs by the authority
OBRAVNAVA VLOG ZA MVO S STRANI AGENCIJE
The Authority's opinion on applications concerning MRLs
Mnenje agencije o vlogah za MVO
The Authority shall assess the applications and the evaluation reports and give a reasoned opinion on, in particular, the risks to the consumer and where relevant to animals associated with the setting, modification or deletion of an MRL.
Agencija preuči vloge in ocenjevalna poročila in poda obrazloženo mnenje zlasti o tveganjih za potrošnika in, kjer je to primerno, za živali v zvezi z določitvijo, spremembo ali izbrisom MVO.
That opinion shall include:
To mnenje vsebuje:
an assessment of whether the analytical method for routine monitoring proposed in the application is appropriate for the intended control purposes;
presojo, ali je predlagana analitska metoda za rutinsko spremljanje v vlogi primerna za predvidene namene nadzora;
the anticipated LOD for the pesticide/product combination;
pričakovane MD za kombinacijo pesticid/proizvod;
an assessment of the risks of the acceptable daily intake or acute reference dose being exceeded as a result of the modification of the MRL; the contribution to the intake due to the residues in the product for which the MRLs was requested;
presojo tveganj prekoračitve dopustnega dnevnega vnosa ali akutnega referenčnega odmerka kot posledice spremembe MVO; prispevek k vnosu zaradi ostankov v proizvodu, za katerega je bila zahtevana MVO;
any other element relevant to the risk assessment.
vse druge elemente, pomembne za oceno tveganja.
The Authority shall forward its reasoned opinion to the applicant, the Commission and the Member States.
Agencija posreduje obrazloženo mnenje vlagatelju, Komisiji in državam članicam.
The reasoned opinion shall clearly define the basis for each conclusion reached.
Iz obrazloženega mnenja mora jasno izhajati podlaga za vsak sprejet zaključek.
Without prejudice to Article 39 of Regulation (EC) No 178/2002, the Authority shall make its reasoned opinion public.
Brez poseganja v člen 39 Uredbe (ES) št. 178/2002 agencija svoje obrazloženo mnenje objavi.
Time limits for the Authority's opinion on applications concerning MRLs
Roki za mnenje agencije o vlogah za MVO
The Authority shall give its reasoned opinion as provided for in Article 10 as soon as possible and at the latest within three months from the date of receipt of the application.
Agencija poda obrazloženo mnenje, kot je določeno v členu 10, v najkrajšem možnem času in najpozneje v treh mesecih od dne prejema vloge.
In exceptional cases where more detailed evaluations need to be carried out, the time limit laid down in the first subparagraph may be extended to six months from the date of receipt of the valid application.
V izjemnih primerih, ko je treba izvesti podrobnejše ocene, se rok iz prvega pododstavka lahko podaljša za šest mesecev od dne prejema veljavne vloge.
Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until that information has been provided.
Če agencija zahteva dodatne informacije, rok, določen v odstavku 1, preneha teči, dokler informacije niso predložene.
Such suspensions are subject to Article 13.
Tako prenehanje teka roka je lahko predmet pregleda iz člena 13.
Assessment of existing MRLs by the Authority
Ocena obstoječih MVO s strani agencije
The Authority shall, within a period of 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC after the entry into force of this Regulation, submit a reasoned opinion based in particular on the relevant assessment report prepared under Directive 91/414/EEC to the Commission and the Member States on:
Agencija po začetku veljavnosti te uredbe v obdobju dvanajstih mesecev od datuma vključitve ali nevključitve aktivne snovi v Prilogo I k Direktivi 91/414/EGS predloži obrazloženo mnenje, ki temelji predvsem na ustreznem ocenjevalnem poročilu, pripravljenem v skladu z Direktivo 91/414/EGS, Komisiji in državam članicam o:
existing MRLs for that active substance set out in Annex II or III to this Regulation;
obstoječih MVO za to aktivno snov, določenih v Prilogi II ali III k tej uredbi;
the necessity of setting new MRLs for that active substance, or its inclusion in Annex IV to this Regulation;
potrebnosti določitve novih MVO za to aktivno snov ali njeno vključitev v Prilogo IV k tej uredbi;
specific processing factors as referred to in Article 20(2) of this Regulation that may be needed for that active substance;
specifičnih predelovalnih faktorjih v smislu člena 20(2) te uredbe, ki so lahko potrebni za to aktivno snov;
MRLs which the Commission may consider including in Annex II and/or Annex III to this Regulation and on those MRLs which may be deleted related to that active substance.
MVO, ki jih Komisija lahko vključi v Prilogo II in/ali Prilogo III, in tistih MVO, ki so v povezavi s to aktivno snovjo lahko izbrisane.
For substances included in Annex I to Directive 91/414/EEC before the entry into force of this Regulation, the reasoned opinion referred to in paragraph 1 of this Article shall be delivered within 12 months of the entry into force of this Regulation.
Za snovi, vključene v Prilogo I k Direktivi 91/414/EGS pred začetkom veljavnosti te uredbe, se obrazloženo mnenje iz odstavka 1 tega člena poda v dvanajstih mesecih od začetka veljavnosti te uredbe.
Administrative review
Upravni pregled
Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.
Katero koli sprejeto odločitev ali neizvrševanje pooblastil, ki so bila podeljena agenciji v skladu s to uredbo, lahko pregleda Komisija po uradni dolžnosti ali na zahtevo države članice ali katere koli neposredno in posamično prizadete osebe.
For that purpose, a request shall be submitted to the Commission within two months after the day on which the party concerned became aware of the act or omission in question.
V ta namen je treba predložiti zahtevo Komisiji v roku dveh mesecev od dneva, ko je zadevna stranka izvedela za zadevno odločitev ali opustitev.
The Commission shall take a decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act within a set time-limit.
Komisija odloči v roku dveh mesecev in, če je to primerno, zahteva od agencije, da umakne svojo odločitev ali da v določenem roku popravi svojo opustitev ukrepanja.
Setting, modifying or deletion of MRLs
DOLOČITEV, SPREMEMBA ALI IZBRIS MVO
Decisions on applications concerning MRLs
Odločitve o vlogah za MVO
Upon receipt of the opinion of the Authority and taking into account that opinion, a Regulation on the setting, modification or deletion of an MRL or a Decision rejecting the application shall be prepared by the Commission without delay and at the latest within three months, and submitted for adoption in accordance with the procedure referred to in Article 45(2).
Po prejemu mnenja agencije in ob upoštevanju tega mnenja Komisija brez odlašanja in najpozneje v roku treh mesecev pripravi in predloži v sprejem v skladu s postopkom iz člena 45(2) uredbo o določitvi, spremembi ali izbrisu MVO ali odločbo o zavrnitvi vloge.
With regard to the acts referred to in paragraph 1, account shall be taken of:
V zvezi z akti iz odstavka 1 se upošteva:
the scientific and technical knowledge available;
razpoložljivo znanstveno in tehnično znanje;
the possible presence of pesticide residues arising from sources other than current plant protection uses of active substances, and their known cumulative and synergistic effects, when the methods to assess such effects are available;
možnost prisotnosti ostankov pesticidov, ki izvirajo iz drugih virov kot trenutnih načinov uporabe aktivnih substanc pri zaščiti rastlin in njihovi poznani kumulativni in sinergijski učinki, ko so na voljo metode za oceno takih učinkov;
the results of an assessment of any potential risks to consumers with a high intake and high vulnerability and, where appropriate, to animals;
rezultate ocene potencialnih tveganj za potrošnike, ki zaužijejo večje količine in so bolj ranljivi, in, kjer je to primerno, za živali;
the results of any evaluations and decisions to modify the uses of plant protection products;
rezultate vseh ocen in odločitev glede sprememb načinov uporabe fitofarmacevtskih sredstev;
a CXL or a GAP implemented in a third country for the legal use of an active substance in that country;
CXL ali DKP, ki se izvaja v tretji državi za zakonito uporabo aktivne snovi v tej državi;
other legitimate factors relevant to the matter under consideration.
druge legitimne dejavnike, ki so pomembni za obravnavano zadevo.
The Commission may request at any time that supplementary information be provided by the applicant or by the Authority.
Komisija lahko od predlagatelja ali agencije kadar koli zahteva predložitev dodatnih informacij.
The Commission shall make available any supplementary information received to the Member States and the Authority.
Komisija da na razpolago vse prejete dodatne informacije državam članicam in agenciji.
Inclusion of new or modified MRLs in Annexes II and III
Vključitev novih ali spremenjenih MVO v prilogah II in III
The Regulation referred in Article 14(1) shall:
Uredba iz člena 14(1):
set new or modified MRLs and list them in Annex II to this Regulation where the active substances have been included in Annex I to Directive 91/414/EEC; or
določi nove ali spremenjene MVO in jih navede v Prilogi II k tej direktivi, če so bile aktivne snovi vključene v Prilogo I k Direktivi 91/414/EGS; ali
where the active substances have not been included in Annex I to Directive 91/414/EEC and where they are not included in Annex II to this Regulation, set or modify temporary MRLs and list them in Annex III to this Regulation; or
če aktivne snovi niso bile vključene v Prilogo I k Direktivi 91/414/EGS in če niso vključene v Prilogo II k tej uredbi, določi ali spremeni začasne MVO in jih navede v Prilogi III k tej uredbi; ali
in the cases mentioned in Article 16, set temporary MRLs and list them in Annex III to this Regulation.
v primerih iz člena 16 določi začasne MVO in jih navede v Prilogi III k tej uredbi.
Where a temporary MRL is set as provided for in paragraph 1(b), it shall be deleted from Annex III by a Regulation one year after the date of the inclusion or non-inclusion in Annex I to Directive 91/414/EEC of the active substance concerned, in accordance with the procedure referred to in Article 45(2) of this Regulation.
Če je določena začasna MVO, kot to določa odstavek 1(b), se jo iz Priloge III izbriše z uredbo v skladu s postopkom iz člena 45(2) te uredbe eno leto po dnevu vključitve ali nevključitve zadevne aktivne snovi v Prilogo I k Direktivi 91/414/EGS.
However, where one or more Member States so request, it may be maintained for an additional year pending confirmation that any scientific studies necessary for supporting an application for setting a MRL have been undertaken.
Če pa to zahteva ena ali več držav članic, se jo lahko ohrani za dodatno leto do potrditve, da so bile začete znanstvene študije v podporo vloge za določitev MVO.
In cases where such confirmation is provided, the temporary MRL shall be maintained for a further two years, provided that no unacceptable safety concerns for the consumer have been identified.
V primerih take potrditve je začasna MVO ohranjena za nadaljnji dve leti, pod pogojem, da niso bili ugotovljeni nikakršni nesprejemljivi zadržki glede varnosti potrošnikov.
Procedure for setting temporary MRLs in certain circumstances
Postopek določitve začasnih MVO v nekaterih okoliščinah
The Regulation referred to in Article 14(1) may also set a temporary MRL to be included in Annex III in the following circumstances:
Uredba iz člena 14(1) lahko določa tudi vključitev začasnih MVO v Prilogo III v naslednjih okoliščinah:
in exceptional cases, in particular where pesticide residues may arise as a result of environmental or other contamination or from uses of plant protection products pursuant to Article 8(4) of Directive 91/414/EEC; or
v izjemnih primerih, predvsem če ostanki pesticidov nastanejo kot posledica okoljske ali druge kontaminacije ali zaradi uporabe fitofarmacevtskih sredstev v skladu s členom 8(4) Direktive 91/414/EGS; ali
where the products concerned constitute a minor component of the diet of consumers, and do not constitute a major part of the diet of relevant subgroups, and, where relevant, of animals; or
če zadevni proizvodi predstavljajo manj pomembno sestavino prehrane potrošnikov in ne predstavljajo pomembnega dela prehrane ustreznih podskupin in, kjer je to primerno, živali; ali
for honey; or
za med; ali
for herbal infusions; or
za zeliščne poparke; ali
where essential uses of plant protection products have been identified by a Decision to delete an active substance from, or not to include an active substance in, Annex I to Directive 91/414/EEC; or
če so bili osnovni načini uporabe fitofarmacevtskih sredstev opredeljeni z odločbo o nevključitvi ali izbrisu aktivne snovi, ki se nahaja v Prilogi I k Direktivi 91/414/EGS; ali
where new products, product groups and/or parts of products have been included in Annex I, and one or more Member States so request, in order to allow any scientific studies necessary for supporting an MRL to be undertaken and evaluated, provided that no unacceptable safety concerns for the consumer have been identified.
če to zahteva ena ali več držav članic, da se omogočita izvedba in ocena znanstvenih raziskav, potrebnih v podporo MVO, pod pogojem da ni bilo ugotovljeno nesprejemljivo tveganje za varnost potrošnika in da so bili novi proizvodi, skupine proizvodov in/ali deli proizvodov vključeni v Prilogo I.
The inclusion of temporary MRLs as referred to in paragraph 1 shall be based on the opinion of the Authority, monitoring data and an assessment demonstrating that there are no unacceptable risks to consumers or animals.
Vključitev začasnih MVO iz odstavka 1 temelji na mnenju agencije, podatkih spremljanja in na oceni, ki izkazuje, da ne obstajajo nesprejemljiva tveganja za potrošnike ali živali.
The continued validity of the temporary MRLs referred to in paragraphs 1(a), (b), (c) and (d) shall be reassessed at least once every 10 years and any such MRLs shall be modified or deleted as appropriate.
Nadaljevanje veljavnosti začasnih MVO iz odstavka 1(a), (b), (c) in (d) se ponovno oceni vsaj vsakih deset let in take MVO se po potrebi spremeni ali izbriše.
The MRLs referred to in paragraph 1(e) shall be reassessed at the expiry of the period for which the essential use was authorised.
MVO iz odstavka 1(e) se ponovno ocenijo po izteku obdobja, za katero je bil registriran osnovni način uporabe.
The MRLs referred to in paragraph 1(f) shall be reassessed when the scientific studies have been completed and evaluated, but no later than four years after their inclusion in Annex III.
MVO iz odstavka 1(f) se ponovno ocenijo, ko se zaključijo in ocenijo znanstvene raziskave, vendar najpozneje v štirih letih po njihovi vključitvi v Prilogo III.