natgillin/translations-raw huggingface dataset:
Where the reasons for not renewing the approval do not concern the protection of health or the environment, the Regulation referred to in paragraph 1 shall provide for a grace period not exceeding six months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned.
Kadar razlogi za zavrnitev obnovitve odobritve ne zadevajo varovanja zdravja ali okolja, se z uredbo iz odstavka 1 zagotovi prehodno obdobje, ki ni daljše od šestih mesecev, za prodajo in distribucijo, ter dodatno prehodno obdobje, ki ni daljše od enega leta, za odstranjevanje, shranjevanje in uporabo obstoječih zalog zadevnih fitofarmacevtskih sredstev.
The grace period for the sale and distribution shall take into account the normal period of use of the plant protection product but the total grace period shall not exceed 18 months.
Pri prvem obdobju se upošteva običajno obdobje uporabe fitofarmacevtskega sredstva, vendar celotno prehodno obdobje ne sme biti daljše od 18 mesecev.
In the case of a withdrawal of the approval or if the approval is not renewed because of the immediate concerns for human health or animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately.
V primeru preklica odobritve ali če odobritev ni obnovljena zaradi neposredne zaskrbljenosti glede zdravja ljudi ali živali ali okolja, se zadevno fitofarmacevtsko sredstvo nemudoma umakne s trga.
Article 13(4) shall apply.
Uporablja se člen 13(4).
Review of approval
Pregled odobritve
The Commission may review the approval of an active substance at any time.
Komisija lahko kadar koli pregleda odobritev aktivne snovi.
It shall take into account the request of a Member State to review, in the light of new scientific and technical knowledge and monitoring data, the approval of an active substance, including where, after the review of the authorisations pursuant to Article 44(1), there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC is compromised.
Komisija upošteva prošnjo države članice za pregled odobritve aktivne snovi v skladu z novimi znanstvenimi in tehničnimi spoznanji in podatki o spremljanju, zlasti kadar je po pregledu odobritev v skladu s členom 44(1) mogoče sklepati, da je ogroženo doseganje ciljev, določenih v skladu s členom 4(1)(a)(iv) in (b)(i) ter členom 7(2) in (3) Direktive 2000/60/ES.
Where, in the light of new scientific and technical knowledge it considers that there are indications that the substance no longer satisfies the approval criteria provided for in Article 4, or further information required in accordance with Article 6(f) has not been provided, it shall inform the Member States, the Authority and the producer of the active substance, setting a period for the producer to submit its comments.
Če glede na nova znanstvena in tehnična spoznanja meni, da obstajajo znaki, da snov ne izpolnjuje več meril za odobritev iz člena 4, ali niso bile predložene zahtevane dodatne informacije v skladu s členom 6(f), o tem obvesti države članice, Agencijo in proizvajalca aktivne snovi ter določi rok, v katerem proizvajalec predloži svoje pripombe.
The Commission may ask the Member States and the Authority for an opinion, or for scientific or technical assistance.
Komisija lahko Agencijo in države članice prosi za mnenje ali znanstveno ali tehnično pomoč.
The Member States may provide their comments to the Commission within three months from the date of the request.
Države članice lahko v treh mesecih od datuma predložitve prošnje Komisije pošljejo svoje pripombe.
The Authority shall provide its opinion or the results of its work to the Commission within three months of the date of the request.
Agencija svoje mnenje ali rezultate svojega dela Komisiji zagotovi v treh mesecih po datumu predložitve prošnje.
Where the Commission concludes that the approval criteria provided for in Article 4 are no longer satisfied, or the further information required in accordance with Article 6(f) has not been provided, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure referred to in Article 79(3).
Če Komisija ugotovi, da snov ne izpolnjuje več meril za odobritev iz člena 4 ali da niso bile predložene zahtevane dodatne informacije v skladu s členom 6(f), se v skladu z regulativnim postopkom iz člena 79(3) sprejme uredba o prenehanju ali spremembi odobritve.
Article 13(4) and Article 20(2) shall apply.
Uporabljata se člen 13(4) in člen 20(2).
Low-risk active substances
Aktivne snovi z majhnim tveganjem
An active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years by way of derogation from Article 5, where it is considered a low-risk active substance and where it may be expected that plant protection products containing that substance will pose only a low risk to human and animal health and the environment as provided for in Article 47(1).
Z odstopanjem od člena 5 se aktivna snov, ki izpolnjuje merila za odobritev iz člena 4, odobri za največ 15 let, kadar šteje za aktivno snov z majhnim tveganjem in kadar se lahko pričakuje, da bo fitofarmacevtsko sredstvo, ki to snov vsebuje, povzročilo le majhno tveganje za zdravje ljudi in živali ter za okolje, kakor je določeno v členu 47(1).
Articles 4 and 6 to 21 and point 5 of Annex II shall apply.
Uporabljajo se členi 4 in 6 do 21 ter točka 5 Priloge II.
Low-risk active substances shall be listed separately in the Regulation referred to in Article 13(4).
Snovi z majhnim tveganjem se navedejo ločeno v uredbi iz člena 13(4).
The Commission may review and if necessary specify new criteria for approving an active substance as low-risk active substance in accordance with Article 78(1)(a).
Komisija lahko pregleda in po potrebi navede nova merila za odobritev aktivne snovi kot snovi z majhnim tveganjem v skladu s členom 78(1)(a).
Approval criteria for basic substances
Merila za odobritev osnovnih snovi
Basic substances shall be approved in accordance with paragraphs 2 to 6.
Osnovne snovi se odobrijo v skladu z odstavki od 2 do 6.
By way of derogation from Article 5, the approval shall be for an unlimited period.
Z odstopanjem od člena 5 se odobritev izda za nedoločen čas.
For the purpose of paragraphs 2 to 6, a basic substance is an active substance which:
Za namene odstavkov 2 do 6 je osnovna snov aktivna snov, ki:
is not a substance of concern; and
ni problematična snov, in
does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects; and
sama po sebi ne povzroča motenj hormonskega ravnovesja ter nima nevrotoksičnih ali imunotoksičnih učinkov, in
is not predominantly used for plant protection purposes but nevertheless is useful in plant protection either directly or in a product consisting of the substance and a simple diluent; and
se običajno ne uporablja za namene varstva rastlin, vendar je vseeno koristna za varstvo rastlin, bodisi neposredno ali v proizvodu, ki je sestavljen iz snovi in enostavnega razredčila, in
is not placed on the market as a plant protection product.
se ne daje v promet kot fitofarmacevtsko sredstvo.
For the purpose of this Regulation, an active substance which fulfils the criteria of a ‘foodstuff’ as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as a basic substance.
Za namen te uredbe se aktivna snov, ki izpolnjuje merila za „živila“, kot so opredeljena v členu 2 Uredbe (ES) št. 178/2002, šteje za osnovno snov.
By way of derogation from Article 4, a basic substance shall be approved where any relevant evaluations, carried out in accordance with other Community legislation regulating the use of that substance for purposes other than for a plant protection product, show that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment.
Z odstopanjem od člena 4 se osnovna snov odobri, če ustrezna ocenjevanja, izvedena v skladu z ostalo zakonodajo Skupnosti, ki ureja uporabo te snovi za druge namene kot za fitofarmacevtska sredstva, dokažejo, da snov nima takojšnjega škodljivega vpliva ali zapoznelega škodljivega vpliva na zdravje ljudi ali živali in nobenega nesprejemljivega vpliva na okolje.
By way of derogation from Article 7 an application for the approval of a basic substance shall be submitted by a Member State or by any interested party to the Commission.
Z odstopanjem od člena 7 zahtevek za odobritev osnovne snovi zainteresirana stran ali država članica predloži Komisiji.
The application shall be accompanied by the following information:
Skupaj z zahtevkom se predložijo naslednji podatki:
any evaluations of its possible effects on human or animal health or the environment carried out in accordance with other Community legislation regulating the use of the substance; and
kakršne koli ocene možnih učinkov snovi na zdravje ljudi ali živali ali okolje, izvedene v skladu z določbami drugih zakonodajnih aktov Skupnosti, ki urejajo uporabo snovi; ter
other relevant information on its possible effects on human or animal health or the environment.
drugi ustrezni podatki o možnih učinkih snovi na zdravje ljudi ali živali ali okolje.
The Commission shall ask the Authority for an opinion, or for scientific or technical assistance.
Komisija Agencijo zaprosi za mnenje ali znanstveno ali tehnično pomoč.
The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the date of the request.
Agencija svoje mnenje ali rezultate svojega dela Komisiji zagotovi v treh mesecih po datumu predložitve prošnje.
Articles 6 and 13 shall apply.
Uporabljata se člena 6 in 13.
Basic substances shall be listed separately in the Regulation referred to in Article 13(4).
Snovi z majhnim tveganjem se navedejo ločeno v uredbi iz člena 13(4).
The Commission may review the approval of a basic substance at any time.
Komisija lahko kadar koli pregleda odobritev osnovne snovi.
It may take into account the request of a Member State to review the approval.
Upošteva lahko zahtevo države članice za pregled odobritve.
Where the Commission considers that there are indications that the substance no longer satisfies the criteria provided for in paragraphs 1 to 3 it shall inform the Member States, the Authority and the interested party, setting a period for their comments to be submitted.
Če Komisija meni, da obstajajo znaki, da snov ne izpolnjuje več meril iz odstavkov 1 do 3, o tem obvesti države članice, Agencijo in zainteresirano stran ter določi rok za predložitev pripomb.
Where the Commission concludes that the criteria referred to in paragraph 1 are no longer satisfied, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure referred to in Article 79(3).
Če Komisija ugotovi, da snov ne izpolnjuje več meril iz odstavka 1, se v skladu z regulativnim postopkom iz člena 79(3) sprejme uredba o prenehanju ali spremembi odobritve.
Candidates for substitution
Kandidatke za zamenjavo
An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding seven years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II.
Aktivna snov, ki izpolnjuje merila iz člena 4, se odobri kot kandidatka za zamenjavo za obdobje, ki ni daljše od sedmih let, če izpolnjuje eno ali več dodatnih meril, določenih v točki 4 Priloge II.
By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding seven years.
Z odstopanjem od člena 14(2) se odobritev lahko obnovi enkrat ali večkrat za obdobja, ki ne presegajo sedem let.
Without prejudice to paragraph 1, Articles 4 to 21 shall apply.
Brez poseganja v odstavek 1 se uporabljajo členi 4 do 21.
Candidates for substitution shall be listed separately in the Regulation referred to in Article 13(4).
Kandidatke za zamenjavo se navedejo ločeno v uredbi iz člena 13(4).
Safeners and synergists
Varovala in sinergisti
Approval of safeners and synergists
Odobritev varoval in sinergistov
A safener or synergist shall be approved, where it complies with Article 4.
Varovalo ali sinergist se odobri, če je izpolnjuje pogoje iz člena 4.
Articles 5 to 21 shall apply.
Uporabljajo se členi 5 do 21.
Similar data requirements to those referred to in Article 8(4) shall be defined for safeners and synergists in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
V skladu z regulativnim postopkom s pregledom iz člena 79(4) se za varovala in sinergiste opredelijo zahteve po podatkih, podobne zahtevam iz člena 8(4).
Safeners and synergists already on the market
Varovala in sinergisti na trgu
By 14 December 2014, a Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4) establishing a work programme for the gradual review of synergists and safeners on the market when that Regulation enters into force.
Do 14. decembra 2014 se v skladu z regulativnim postopkom s pregledom iz člena 79(4) sprejme uredba o vzpostavitvi delovnega programa za postopen pregled sinergistov in varoval, ki so na trgu ob začetku veljavnosti te uredbe.
The Regulation shall include the establishment of data requirements, including measures to minimise animal testing, notification, evaluation, assessment and decision-making procedures.
Uredba vključuje določitev zahtev po podatkih, vključno z ukrepi za omejitev poskusov na živalih, ter za postopke obveščanja, vrednotenja, ocenjevanja in odločanja.
It shall require interested parties to submit all the necessary data to the Member States, the Commission and the Authority within a specified period.
Od zainteresiranih strani zahteva, da Komisiji, Agenciji in državam članicam v določenem roku predložijo vse potrebne podatke.
Unacceptable co-formulants
Nesprejemljivi dodatki
Co-formulants
Dodatki
A co-formulant shall not be accepted for inclusion in a plant protection product where it has been established that:
Dodatek se ne odobri za vključitev v fitofarmacevtsko sredstvo, kadar se ugotovi, da:
its residues, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment; or
njegovi ostanki, kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe, škodljivo vplivajo na zdravje ljudi ali živali, podzemno vodo ali okolje; ali
its use, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, has a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment.
njegova uporaba, kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe, škodljivo vpliva na zdravje ljudi ali živali ali nesprejemljivo vpliva na rastline, rastlinske proizvode ali okolje.
Co-formulants which are not accepted for inclusion in a plant protection product pursuant to paragraph 1 shall be included in Annex III in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
Dodatki, ki niso odobreni za vključitev v fitofarmacevtska sredstva, v skladu z odstavkom 1, se v skladu z regulativnim postopkom s pregledom iz člena 79(4) vključijo v Prilogo III.
The Commission may review co-formulants at any time.
Komisija lahko kadar koli pregleda dodatke.
It may take into account relevant information provided by Member States.
Lahko upošteva ustrezne informacije, ki jih predložijo države članice.
Article 81(2) shall apply.
Uporablja se člen 81(2).
Detailed rules for the implementation of this Article may be established in accordance with the regulatory procedure referred to in Article 79(3).
Podrobna pravila za izvajanje tega člena se lahko sprejmejo v skladu z regulativnim postopkom iz člena 79(3).
PLANT PROTECTION PRODUCTS
FITOFARMACEVTSKA SREDSTVA
Requirements and contents
Zahteve in vsebina
Authorisation for placing on the market and use
Registracija dajanja v promet in uporabe
A plant protection product shall not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with this Regulation.
Fitofarmacevtsko sredstvo se ne da v promet in se ne uporabi, če ga zadevna država članica ni registrirala v skladu s to uredbo.
By way of derogation from paragraph 1, no authorisation shall be required in the following cases:
Z odstopanjem od odstavka 1 se registracija ne zahteva v naslednjih primerih:
use of products containing exclusively one or more basic substances;
uporaba sredstev, ki vsebujejo izključno eno ali več osnovnih snovi;
placing on the market and use of plant protection products for research or development purposes in accordance with Article 54;
dajanje v promet in uporaba fitofarmacevtskih sredstev za raziskovalne ali razvojne namene v skladu s členom 54;
production, storage or movement of a plant protection product intended for use in another Member State, provided that the product is authorised in that Member State and that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is not used in its territory;
proizvodnja, shranjevanje ali prevoz fitofarmacevtskega sredstva, namenjenega za uporabo v drugi državi članici, če je sredstvo v tej državi članici registrirano in je država članica proizvodnje, skladiščenja ali prevoza določila inšpekcijske zahteve za zagotovitev, da se fitofarmacevtsko sredstvo ne uporablja na njenem ozemlju;
production, storage or movement of a plant protection product intended for use in a third country provided that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is exported from its territory;
proizvodnja, shranjevanje ali prevoz fitofarmacevtskega sredstva, namenjenega za uporabo v tretji državi, če je država članica proizvodnje, skladiščenja ali prevoza določila inšpekcijske zahteve za zagotovitev, da se fitofarmacevtsko sredstvo izvozi iz njenega ozemlja;
placing on the market and use of plant protection products for which a parallel trade permit has been granted in accordance with Article 52.
dajanje v promet in uporaba fitofarmacevtskih sredstev, za katera je bilo izdano dovoljenje za vzporedno trgovanje v skladu s členom 52.
Requirements for the authorisation for placing on the market
Zahteve za registracijo dajanja v promet
Without prejudice to Article 50 a plant protection product shall only be authorised where following the uniform principles referred to in paragraph 6 it complies with the following requirements:
Brez poseganja v člen 50 se fitofarmacevtsko sredstvo registrira le, če na podlagi enotnih načel iz odstavka 6 izpolnjuje naslednje zahteve:
its active substances, safeners and synergists have been approved;
njegove aktivne snovi, varovala in sinergisti so bili odobreni;
where its active substance, safener or synergist is produced by a different source, or by the same source with a change in the manufacturing process and/or manufacturing location:
če se aktivna snov, varovalo ali sinergist proizvede v drugem viru ali v istem viru s spremenjenim postopkom izdelave in/ali mestom izdelave:
the specification, pursuant to Article 38, does not deviate significantly from the specification included in the Regulation approving that substance, safener or synergist; and
specifikacija v skladu s členom 38 bistveno ne odstopa od specifikacij iz uredbe o odobritvi te snovi, varovala ali sinergista; ter
the active substance, safener or synergist has no more harmful effects within the meaning of Article 4(2) and (3) due to its impurities than if it had been produced in accordance with the manufacturing process specified in the dossier that supported the approval;
aktivna snov, varovalo ali sinergist nima več škodljivih vplivov v smislu člena 4(2) in(3) zaradi nečistoč, kot če bi bil proizveden v skladu s proizvodnim postopkom, navedenim v dokumentaciji, ki je bila podlaga za registracijo;
its co-formulants are not included in Annex III;
njegovi dodatki niso vključeni v Prilogo III;
its technical formulation is such that user exposure or other risks are limited as much as possible without compromising the functioning of the product;
njegova tehnična formulacija je takšna, da so izpostavljenost uporabnika ali druga tveganja čim bolj omejeni, ne da bi to ogrozilo delovanje sredstva;
in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3);
glede na sedanje znanstvena in tehnična spoznanja je v skladu z zahtevami iz člena 4(3);
the nature and quantity of its active substances, safeners and synergists and, where appropriate, any toxicologically, ecotoxicologically or environmentally relevant impurities and co-formulants can be determined by appropriate methods;
vrsta in količina aktivnih snovi, varoval in sinergistov ter, po potrebi, katere koli toksikološko, ekotoksikološko ali okoljsko relevantne nečistoče in dodatki se lahko določijo z ustreznimi metodami;
its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental relevance, can be determined by appropriate methods in general use in all Member States, with appropriate limits of determination on relevant samples;
ostanki, ki nastanejo pri registriranih uporabah in so toksikološko, ekotoksikološko ali okoljsko relevantni, se lahko določijo z ustreznimi splošno razširjenimi metodami v vseh državah članicah, s primernimi mejami določitve za ustrezne vzorce;
its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product;
določene so bile njegove fizikalne in kemijske lastnosti ter se štejejo za sprejemljive za namene primerne uporabe in shranjevanja sredstva;
for plants or plant products to be used as feed or food, where appropriate, the maximum residue levels for the agricultural products affected by the use referred to in the authorisation have been set or modified in accordance with Regulation (EC) No 396/2005.
za rastline ali rastlinske proizvode, namenjene za prehrano in krmo, so bile mejne vrednosti ostankov za kmetijske proizvode, na katere vpliva uporaba iz registracije, po potrebi določene ali spremenjene v skladu z Uredbo (ES) št. 396/2005.
The applicant shall demonstrate that the requirements provided for in points (a) to (h) of paragraph 1 are met.
Vlagatelj dokaže, da so zahteve iz odstavka 1(a) do (h) izpolnjene.
Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used.
Skladnost z zahtevami iz odstavka 1(b) in (e) do (h) se določi z uradnimi ali uradno priznanimi preskusi in analizami, izvedenimi v skladu s kmetijskimi in okoljskimi razmerami ter razmerami za zdravje rastlin, ki so pomembne za uporabo zadevnega fitofarmacevtskega sredstva in predstavljajo razmere, ki prevladujejo v coni, kjer se bo sredstvo uporabljalo.
With respect to point (f) of paragraph 1, harmonised methods may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
Glede na odstavek 1(f) se lahko sprejmejo usklajene metode v skladu z regulativnim postopkom s pregledom iz člena 79(4).
Article 81 shall apply.
Uporablja se člen 81.