natgillin/translations-raw huggingface dataset:
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.
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 procedure referred to in Article 45(2) of this Regulation at the request of the applicant.
Te vloge se predložijo v skladu s členom 7.
Such applications shall be made in accordance with Article 7 of this Regulation.
Vlagatelj vključi v vlogo za MVO naslednje informacije in dokumente:
The applicant shall include in an application for an MRL the following particulars and documents:
ime in naslov vlagatelja;
the name and address of the applicant;
predložitev dosjeja z vlogo, ki vključuje:
a presentation of the application dossier including:
kopijo ustrezne DKP, ki se uporablja za poseben način uporabe te aktivne snovi;
a copy of the relevant GAP applying to the specific use of that active substance;
popoln pregled relevantnih zadev v dostopni znanstveni literaturi o proizvodih za zaščito rastlin in/ali o njihovih ostankih
a comprehensive overview of relevant concerns raised in the available scientific literature about the plant protection product and/or its residue
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.
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.
V teh primerih bo ocenjevalno poročilo vključevalo obrazložitev v zvezi z uporabo oziroma neuporabo teh podatkov.
In such cases, the evaluation report shall include a justification for using or not using such data.
Člen 8 Ocenjevanje vlog
Article 8 Evaluation of Applications
Država članica, ki ji je v skladu s členom 6 predložena vloga, ki izpolnjuje pogoje iz člena 7, kopijo vloge nemudoma posreduje
A Member State to which an application complying with Article 7 is submitted pursuant to Article 6 shall immediately forward a copy to the
agenciji in
Authority and
Komisiji ter brez nepotrebnega odlašanja pripravi ocenjevalno poročilo.
the Commission and draw up an evaluation report without undue delay.
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.
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.
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.
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.
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.
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.
Po dokončanju ocenjevalnega poročila ga država članica posreduje Komisiji.
After completion of the evaluation report, the Member State shall forward it to the Commission.
Komisija brez odlašanja obvesti države članice in agenciji posreduje vlogo, ocenjevalno poročilo in spremljevalni dosje.
The Commission shall without delay inform the Member States and forward the application, the evaluation report and the supporting dossier to the Authority.
Agencija brez odlašanja pisno potrdi prejem vloge vlagatelju, ocenjujoči državi članici in Komisiji.
The Authority shall acknowledge in writing receipt of the application to the applicant, the evaluating Member State and the Commission without delay.
Potrdilo navaja datum prejema vloge in spremljajoče dokumente.
The acknowledgement shall state the date of receipt of the application and the accompanying documents.
Obravnava vlog za MVO s strani agencije
Consideration of applications concerning MRLs by the Authority
To mnenje vsebuje:
That opinion shall include:
pričakovane MD za kombinacijo pesticid/proizvod;
the anticipated LOD for the pesticide/product combination;
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;
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;
vse druge elemente, pomembne za oceno tveganja.
any other element relevant to the risk assessment.
Agencija posreduje obrazloženo mnenje vlagatelju, Komisiji in državam članicam.
The Authority shall forward its reasoned opinion to the applicant, the Commission and the Member States.
Iz obrazloženega mnenja mora jasno izhajati podlaga za vsak sprejet zaključek.
The reasoned opinion shall clearly define the basis for each conclusion reached.
Brez poseganja v člen 39 Uredbe (ES) št. 178/2002 agencija svoje obrazloženo mnenje objavi.
Without prejudice to Article 39 of Regulation (EC) No 178/2002, the Authority shall make its reasoned opinion public.
V izjemnih primerih, ko je treba izvesti podrobnejše ocene, se rok iz prvega pododstavka lahko podaljša za šest mesecev od dneva prejema veljavnega zahtevka.
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.
Če agencija zahteva dodatne informacije, rok, določen v odstavku 1, preneha teči, dokler informacije niso predložene.
Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until that information has been provided.
Tako prenehanje teka roka je lahko predmet pregleda iz člena 13.
Such suspensions are subject to Article 13.
Člen 12 Ocena obstoječih MVO s strani agencije
Article 12 Assessment of existing MRLs by the Authority
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:
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:
obstoječih MVO za to aktivno snov, določenih v Prilogi II ali III k tej uredbi;
existing MRLs for that active substance set out in Annex II or III to this Regulation;
potrebnosti določitve novih MVO za to aktivno snov ali njeno vključitev v Prilogo IV k tej uredbi;
the necessity of setting new MRLs for that active substance, or its inclusion in Annex IV to this Regulation;
specifičnih predelovalnih faktorjih v smislu člena 20(2) te uredbe, ki so lahko potrebni za to aktivno snov;
specific processing factors as referred to in Article 20(2) of this Regulation that may be needed for 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.
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.
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.
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.
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.
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.
V zvezi z akti iz odstavka 1 se upošteva:
With regard to the acts referred to in paragraph 1, account shall be taken of:
razpoložljivo znanstveno in tehnično znanje;
the scientific and technical knowledge available;
možnost prisotnosti ostankov pesticidov, ki izvirajo iz drugih virov kot trenutnih načinov uporabe aktivnih substanc pri zaščiti rastlin
the possible presence of pesticide residues arising from other sources than current plant protection uses of active substances
in njihovi znani kumulativni in sinergijski učinki, ko so na voljo metode za oceno takih učinkov
, and their known cumulative and synergistic effects, when the methods to assess such effects are available
rezultate ocene potencialnih tveganj za
the results of an assessment of any potential risks to
potrošnike, ki zaužijejo največ in ki so najbolj ogroženi,
consumers with a high intake and high vulnerability
in, kjer je to primerno, za živali;
and, where appropriate, to animals;
rezultate vseh ocen in odločitev glede sprememb načinov uporabe fitofarmacevtskih sredstev;
the results of any evaluations and decisions to modify the uses of plant protection products;
CXL ali DKP, ki se izvaja v tretji državi za zakonito uporabo aktivne snovi v tej državi;
a CXL or a GAP implemented in a third country for the legal use of an active substance in that country;
druge legitimne dejavnike, ki so pomembni za obravnavano zadevo.
other legitimate factors relevant to the matter under consideration.
Komisija lahko od predlagatelja ali agencije kadar koli zahteva predložitev dodatnih informacij.
The Commission may request at any time that supplementary information be provided by the applicant or by the Authority.
Komisija da na razpolago vse prejete dodatne informacije državam članicam in agenciji.
The Commission shall make available any supplementary information received to the Member States and the Authority.
Uredba iz člena 14(1):
The Regulation referred in Article 14(1) shall:
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
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
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
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
v primerih iz člena 16 določi začasne MVO in jih navede v Prilogi III k tej uredbi.
in the cases mentioned in Article 16, set temporary MRLs and list them in Annex III to 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.
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 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.
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.
V primerih take potrditve je začasna MVO ohranjena za nadaljnji dve leti, pod pogojem, da niso bili ugotovljeni nikakršni nesprejemljivi zadržki glede varnosti potrošnikov.
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.
Uredba iz člena 14(1) lahko določa tudi vključitev začasnih MVO v Prilogo III v naslednjih 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:
če zadevni proizvodi predstavljajo manj pomembno sestavino prehrane potrošnikov
where the products concerned constitute a minor component of the diet of consumers
za med ali
for honey; or
za zeliščne poparke
for herbal infusions;
) 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
) 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;
kadar se novi proizvodi, skupine proizvodov in/ali deli proizvodov na zahtevo ene ali več držav članic vključijo v Prilogo I, da se omogočita izvedba in ocena znanstvenih raziskav, potrebnih za podporo MVO, če ni ugotovljeno nesprejemljivo tveganje za varnost potrošnika.
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.
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 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.
Nadaljevanje veljavnosti začasnih MVO iz odstavka 1(a),
The continued validity of the temporary MRLs referred to in paragraph 1(a),
MVO iz odstavka 1(
paragraph 1(e)
Mejne vrednosti ostankov iz odstavka 1(f), se ponovno določijo, ko se zaključijo in ovrednotijo znanstvene raziskave, ampak ne pozneje kot štiri leta po tem, ko so bile vključene v Prilogo III.
The MRLs referred to in paragraph 1(f) shall be re-assessed when the scientific studies have been completed and evaluated, but no later than four years after their inclusion in Annex III.
Spremembe Priloge II ali III, potrebne zaradi izbrisa MVO zaradi preklica obstoječe registracije fitofarmacevtskega sredstva, se lahko sprejmejo brez pridobitve mnenja agencije.
Amendments to Annexes II or III needed to delete an MRL following the revocation of an existing authorisation for a plant protection product may be adopted without seeking the opinion of the Authority.
MVO, KI SE UPORABLJAJO ZA PROIZVODE RASTLINSKEGA IN ŽIVALSKEGA IZVORA
MRLS APPLICABLE TO PRODUCTS OF PLANT AND ANIMAL ORIGIN
Proizvodi iz Priloge I od trenutka, ko so dani na trg kot hrana ali krma ali se z njimi krmi živali, ne vsebujejo nobenih ostankov pesticidov, ki presegajo:
The products covered by Annex I shall not contain, from the time they are placed on the market as food or feed, or fed to animals, any pesticide residue exceeding:
MVO za te proizvode, določene v Prilogah II in III;
the MRLs for those products set out in Annexes II and III;
Te privzete vrednosti so določene v Prilogi V.
Such default values shall be listed in Annex V.
Države članice na svojem ozemlju ne smejo prepovedati ali ovirati dajanja v promet proizvodov iz Priloge I ali krmljenja živali, namenjenih prehrani, s temi proizvodi zaradi njihove vsebnosti ostankov pesticidov, pod pogojem, da:
Member States may not prohibit or impede the placing on the market or the feeding to food-producing animals within their territories of the products covered by Annex I on the grounds that they contain pesticide residues provided that:
so ti proizvodi skladni
such products comply with
je aktivna snov navedena v Prilogi IV.
the active substance is listed in Annex IV.
Z odstopanjem od odstavka 1 lahko država članica na svojem ozemlju dovoli pri tretiranju po pobiranju pridelka s fumigantom vrednosti ostankov aktivnih snovi, ki presegajo meje, določene v Prilogah II in III za proizvode iz Priloge I, če so te kombinacije aktivna snov/proizvod navedene v Prilogi VII, pod pogojem, da:
By way of derogation from paragraph 1, Member States may authorise, further to a post-harvest treatment with a fumigant on their own territory, residue levels for an active substance which exceed the limits specified in Annexes II and III for a product covered by Annex I where the active substance/product combinations are listed in Annex VII provided that:
ti proizvodi niso namenjeni takojšnji uporabi;
such products are not intended for immediate consumption;
obstaja primeren nadzor, ki zagotavlja, da taki proizvodi ne morejo biti dostopni končnemu porabniku ali potrošniku, če so mu dobavljeni neposredno, vse dokler ostanki presegajo mejne vrednosti, določene v Prilogah II ali III;
appropriate controls are in place to ensure that such products cannot be made available to the end user or consumer, if they are supplied directly to the latter, until the residues no longer exceed the maximum levels specified in Annexes II or III;
druge države članice in Komisija so bile obveščene o sprejetih ukrepih.
the other Member States and the Commission have been informed of the measures taken.
Kombinacije aktivna snov/proizvod iz Priloge VII se opredelijo v skladu s postopkom iz člena 45(2).
The active substance/product combinations listed in Annex VII shall be defined in accordance with the procedure referred to in Article 45(2).
V izjemnih okoliščinah in predvsem pri uporabi fitofarmacevtskih sredstev v skladu s členom 8(4) Direktive 91/414/EGS ali pri uresničevanju obveznosti iz Direktive 2000/29/ES Direktiva Sveta 2000/29/ES z dne 8. maja 2000 o varstvenih ukrepih proti vnosu organizmov, škodljivih za rastline ali rastlinske proizvode, v Skupnost in proti njihovemu širjenju v Skupnosti (UL L 169, 10.7.2000, str.
In exceptional circumstances, and in particular further to the use of plant protection products in accordance with Article 8(4) of Directive 91/414/EEC or in pursuance of obligations in Directive 2000/29/EC Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 169,10.7.2000, p.
Direktiva, kakor je bila nazadnje spremenjena z
Directive as last amended by
O teh dovoljenjih se nemudoma uradno obvesti druge države članice, Komisijo in agencijo, vključno z ustrezno oceno tveganja, ki se brez nepotrebnega odlašanja obravnava v skladu s postopkom iz člena 45(2), da bi se določilo začasno MVO za določeno obdobje ali sprejelo kateri koli drug potreben ukrep v zvezi s temi proizvodi.
Such authorisations shall immediately be notified to the other Member States, the Commission and the Authority, together with an appropriate risk assessment for consideration without undue delay in accordance with the procedure referred to in Article 45(2), with a view to setting a temporary MRL for a specified period or taking any other necessary measure in relation to such products.
Člen 19 Prepoved glede predelanih in/ali sestavljenih proizvodov
Article 19 Prohibition concerning processed and/or composite products
Proizvode iz Priloge I, ki niso skladni s členom 18(1) ali 20, je prepovedano predelovati in/ali mešati za namene razredčenja z istimi ali drugimi proizvodi, z namenom dati jih na trg kot hrano ali krmo ali z njimi krmiti živali.
The processing, and/or mixing for dilution purposes with the same or other products, of the products covered by Annex I not complying with Article 18(1) or 20 with a view to placing them on the market as food or feed or feeding them to animals shall be prohibited.
Če MVO niso določene v Prilogi II ali III za predelano in/ali sestavljeno hrano ali krmo, se uporabljajo MVO, navedene v členu 18(1) za ustrezne proizvode iz Priloge I, ob upoštevanju sprememb v vrednostih ostankov pesticidov, ki jih povzročijo predelava in/ali mešanje.
Where MRLs are not set out in Annexes II or III for processed and/or composite food or feed, the MRLs applicable shall be those provided in Article 18(1) for the relevant product covered by Annex I, taking into account changes in the levels of pesticide residues caused by processing and/or mixing.
V seznam iz Priloge VI se lahko vključijo v skladu s postopkom iz člena 45(2) posebni faktorji koncentracije ali redčenja za določene operacije predelave in/ali mešanja ali za določene predelane in/ali sestavljene proizvode.
Specific concentration or dilution factors for certain processing and/or mixing operations or for certain processed and/or composite products may be included in the list in Annex VI in accordance with the procedure referred to in Article 45(2).
POSEBNE DOLOČBE GLEDE PREVZEMA OBSTOJEČIH MVO V TO UREDBO
SPECIAL PROVISIONS RELATING TO THE INCORPORATION OF EXISTING MRLS INTO THIS REGULATION
Priloga II se sestavi v roku dvanajstih mesecev od začetka veljavnosti te uredbe.
Annex II shall be established within 12 months from the entry into force of this Regulation.
preostalih MVO v Prilogi k Direktivi 76/895/EGS in
remaining MRLs in the Annex to Directive 76/895/EEC; and
doslej neusklajenih nacionalnih MVO.
hitherto unharmonised national MRLs.
Priloga III se sestavi v roku dvanajstih mesecev od začetka veljavnosti te uredbe v skladu s členi 23, 24 in 25.
Annex III shall be established within 12 months from the entry into force of this Regulation in accordance with Articles 23, 24 and 25.
Člen 23 Informacije, ki jih priskrbi država članica o nacionalnih MVO
Article 23
Če aktivna snov še ni vključena v Prilogo I k Direktivi 91/414/EGS in če je država članica
Information to be provided by the Member States on national MRLs
o DKP;
the GAP;
o zbirnih podatkih o nadzorovanih poizkusih in/ali podatkih spremljanja, če se v državi članici uporablja kritična DKP in če so na razpolago;
where the critical GAP is applied in the Member State and, where available, summary data on supervised trials and/or monitoring data;
Komisiji obrazloženo mnenje o možnih tveganjih za zdravje potrošnika iz:
Authority shall provide a reasoned opinion to the Commission on potential risks to consumer health arising from: