natgillin/translations-raw huggingface dataset:
In particular, references in other Community legislation, such as Regulation (EC) No 1782/2003, to Article 3 of Directive 91/414/EEC shall be construed as references to Article 55 of this Regulation.
Zlasti sklicevanja v drugih zakonodajnih aktih Skupnosti, kakor v Uredbi (ES) št. 1782/2003, na člen 3 Direktive 91/414/EGS, se razumejo kot sklicevanja na člen 55 te uredbe.
By 14 June 2011, the Commission shall adopt the following:
Do 14. junija 2011 Komisija sprejme:
a Regulation containing the list of the active substances already approved at the moment of adoption of that Regulation;
uredbo s seznamom aktivnih snovi, ki so v času objave zadevne uredbe že odobrene;
a Regulation on data requirements for active substances, as referred to in Article 8(1)(b);
uredbo o zahtevah po podatkih za aktivne snovi, kakor je navedeno v členu 8(1)(b);
a Regulation on data requirements for plant protection products, as referred to in Article 8(1)(c);
uredbo o zahtevah po podatkih za fitofarmacevtska sredstva, kakor je navedeno v členu 8(1)(c);
a Regulation on uniform principles for risk assessment for plant protection products, as referred to in Article 36;
uredbo o enotnih načelih za oceno tveganja fitofarmacevtskih sredstev, kakor je navedeno v členu 36;
a Regulation containing the requirements of the labelling of plant protection products, as referred to in Article 65(1).
uredbo o zahtevah glede označevanja fitofarmacevtskih sredstev, kakor je navedeno v členu 65(1).
This Regulation shall apply from 14 June 2011.
Ta uredba se uporablja od 14. junija 2011.
OJ C 175, 27.7.2007, p. 44.
UL C 175, 27.7.2007, str. 44.
OJ C 187 E, 7.8.2003, p. 173.
UL C 187 E, 7.8.2003, str. 173.
Definition of zones for the authorisation of plant protection products as referred to in Article 3(17)
Opredelitev con za registracijo fitofarmacevtskih sredstev iz člena 3(17)
Zone A — North
Cona A – sever
The following Member States belong to this zone:
V to cono sodijo naslednje države članice:
Denmark, Estonia, Latvia, Lithuania, Finland, Sweden
Danska, Estonija, Latvija, Litva, Finska, Švedska
Zone B — Centre
Cona B – osrednji del
Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Romania, Slovenia, Slovakia, United Kingdom
Belgija, Češka, Nemčija, Irska, Luksemburg, Madžarska, Nizozemska, Avstrija, Poljska, Romunija, Slovenija, Slovaška, Združeno kraljestvo
Zone C — South
Cona C – jug
Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta, Portugal
Bolgarija, Grčija, Španija, Francija, Italija, Ciper, Malta, Portugalska
Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II
Postopek in merila za odobritev aktivnih snovi, varoval in sinergistov v skladu s poglavjem II
During the process of evaluation and decision-making provided for in Articles 4 to 21, the rapporteur Member State and the Authority shall cooperate with applicants to resolve any questions on the dossier quickly or to identify at an early stage any further explanations or additional studies necessary for the evaluation of the dossier, including information to eliminate the need for a restriction of the approval, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Regulation.
Med postopkom ocenjevanja in odločanja iz členov 4 do 21 država članica poročevalka in Agencija sodelujeta z vlagatelji vlog, da se hitro rešijo kakršna koli vprašanja v zvezi z dokumentacijo ali da se na začetni stopnji opredelijo kakršne koli dodatne razlage ali študije, potrebne za oceno dokumentacije, vključno z informacijami na podlagi katerih je odveč omejevanje odobritve, ali sprememba kakršnih koli predlaganih pogojev uporabe fitofarmacevtskega sredstva ali spremembe njegove narave ali sestave za zagotovitev popolnega izpolnjevanja zahtev iz te uredbe.
The evaluation by the Authority and the rapporteur Member State must be based on scientific principles and be made with the benefit of expert advice.
Ocena Agencije in države članice poročevalke mora temeljiti na znanstvenih načelih, ob upoštevanju izvedenskih mnenj.
During the process of evaluation and decision-making provided for in Articles 4 to 21, Member States and the Authority shall take into consideration any further guidance developed in the framework of the Standing Committee on the Food Chain and Animal Health for the purposes of refining, where relevant, the risk assessments.
Med postopkom ocenjevanja in odločanja iz členov 4 do 21 države članice in Agencija, kjer je to ustrezno, upoštevajo kakršne koli dodatne smernice, izdelane v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali, za namene izboljšanja ocene tveganja.
General decision-making criteria
Splošna merila za odločanje
Article 4 shall only be considered as complied with, where, on the basis of the dossier submitted, authorisation in at least one Member State is expected to be possible for at least one plant protection product containing that active substance for at least one of the representative uses.
Določbe iz člena 4 so izpolnjene le, če se na podlagi predložene dokumentacije pričakuje, da bo registracija v vsaj eni državi članici mogoča za vsaj eno fitofarmacevtsko sredstvo, ki vsebuje zadevno aktivno snov, za vsaj eno od reprezentativnih uporab.
Submission of further information
Predložitev dodatnih informacij
In principle an active substance, safener or synergist shall only be approved where a complete dossier is submitted.
Načeloma se aktivna snov, varovalo ali sinergist odobri le, če se predloži popolna dokumentacija.
In exceptional cases an active substance, safener or synergist may be approved even though certain information is still to be submitted where:
V izjemnih primerih se aktivna snov, varovalo ali sinergist lahko odobri, čeprav nekatere informacije še niso predložene, če:
the data requirements have been amended or refined after the submission of the dossier; or
so bile zahteve po podatkih po predložitvi dokumentacije spremenjene ali podrobneje opredeljene, ali
the information is considered to be confirmatory in nature, as required to increase confidence in the decision.
so informacije potrditvene narave, torej takšne, na podlagi katerih se lahko potrdi odločitev.
Restrictions on approval
Omejitve odobritve
Where necessary, the approval may be subject to conditions and restrictions as referred to in Article 6.
Kadar je to potrebno, za odobritev lahko veljajo pogoji in omejitve iz člena 6.
Where the rapporteur Member State considers that the dossier provided lacks certain information, to the effect that the active substance could only be approved subject to restrictions, it shall contact the applicant at an early stage to obtain more information which may possibly enable these restrictions to be removed.
Če država članica poročevalka meni, da v predloženi dokumentaciji manjkajo nekatere informacije in to pomeni, da se aktivna snov lahko odobri le z omejitvami, čim prej obvesti vlagatelja, da pridobi več informacij, ki lahko omogočijo odstranitev teh omejitev.
Criteria for the approval of an active substance
Merila za odobritev aktivne snovi
The dossiers submitted pursuant to Article 7(1) shall contain the information needed to establish, where relevant, Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL) and Acute Reference Dose (ARfD).
Dokumentacija, predložena v skladu s členom 7(1), kjer je to ustrezno vključuje informacije, potrebne za določitev sprejemljivega dnevnega vnosa (ADI), dopustne ravni izpostavljenosti izvajalca (AOEL) in akutnega referenčnega odmerka (ARfD).
In the case of an active substance, safener or synergist for which one or more representative uses includes use on feed or food crops or leads indirectly to residues in food or feed, the dossier submitted pursuant to Article 7(1) shall contain the information necessary to carry out a risk assessment and for enforcement purposes.
V primeru aktivne snovi, varovala ali sinergista, katere/-ga ena ali več reprezentativnih rab vključuje uporabo na pridelkih, namenjenih za prehrano ali krmo, ali posredno povzroča ostanke v hrani ali krmi, vključuje dokumentacija, predložena v skladu s členom 7(1), informacije, potrebne za izvedbo ocene tveganja in za namene nadzora.
The dossier shall in particular:
Dokumentacija zlasti:
permit any residue of concern to be defined;
omogoča opredelitev kakršnih koli problematičnih ostankov;
reliably predict the residues in food and feed, including succeeding crops;
zanesljivo napove ostanke v hrani in krmi, vključno s posevki, ki sledijo v kolobarju;
reliably predict, where relevant, the corresponding residue level reflecting the effects of processing and/or mixing;
zanesljivo napove, kjer je to primerno, ustrezno vrednost ostankov, ki odraža učinke predelave in/ali mešanja;
permit a maximum residue level to be defined and to be determined by appropriate methods in general use for the commodity and, where appropriate, for products of animal origin where the commodity or parts of it is fed to animals;
omogoča opredelitev in določitev mejne vrednosti ostankov za rastlinske proizvode z ustreznimi metodami, ki se na splošno uporabljajo za rastlinske proizvode, in – kjer je to primerno – za proizvode živalskega izvora, če se z rastlinskim proizvodom ali njegovimi deli hranijo živali;
permit, where relevant, concentration or dilution factors due to processing and/or mixing to be defined.
omogoča opredelitev, kjer je to ustrezno, faktorjev koncentracije ali razredčitve zaradi predelave in/ali mešanja.
The dossier submitted pursuant to Article 7(1) shall be sufficient to permit, where relevant, an estimate of the fate and distribution of the active substance in the environment, and its impact on non-target species.
Dokumentacija, predložena v skladu s členom 7(1) je zadostna, da, kjer je to ustrezno, omogoči oceno usode in porazdelitve aktivne snovi v okolju in njenega vpliva na neciljne vrste.
An active substance alone or associated with a safener or synergist shall only be approved where it has been established for one or more representative uses that the plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use is sufficiently effective.
Aktivna snov sama ali v povezavi z varovalom ali sinergistom se odobri le, če je bilo za eno ali več reprezentativnih rab ugotovljeno, da je fitofarmacevtsko sredstvo po uporabi v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe dovolj učinkovito.
This requirement shall be evaluated in accordance with the uniform principles for evaluation and authorisation of plant protection products referred to in Article 29(6).
Ta zahteva se oceni glede na enotna načela za oceno in registracijo fitofarmacevtskih sredstev iz člena 29(6).
Relevance of metabolites
Relevantnost metabolitov
Where applicable the documentation submitted shall be sufficient to permit the establishment of the toxicological, ecotoxicological or environmental relevance of metabolites.
Kjer je to primerno, predložena dokumentacija zadostuje, da se določi toksikološki, ekotoksikološki ali okoljski pomen metabolitov.
Composition of the active substance, safener or synergist
Sestava aktivne snovi, varovala ali sinergista.
The specification shall define the minimum degree of purity, the identity and maximum content of impurities and, where relevant, of isomers/diastereo-isomers and additives, and the content of impurities of toxicological, ecotoxicological or environmental concern within acceptable limits.
Specifikacija opredeljuje najmanjšo stopnjo čistosti, vrsto in največjo vsebnost nečistoč, in kjer relevantno, izomerov/diastereoizomerov in aditivov ter vsebnost nečistoč, ki so toksikološko, ekotoksikološko ali okoljsko nevarne, s sprejemljivimi mejami.
The specification shall be in compliance with the relevant Food and Agriculture Organisation specification as appropriate, where such specification exists.
Specifikacija je – kakor je ustrezno – v skladu z ustrezno specifikacijo FAO, če takšna specifikacija obstaja.
However, where necessary for reasons of protection of human or animal health or the environment, stricter specifications may be adopted.
Vendar se lahko sprejmejo strožje specifikacije, če je to potrebno zaradi varovanja zdravja ljudi ali živali ali okolja.
The methods of analysis of the active substance, safener or synergist as manufactured and of determination of impurities of toxicological, ecotoxicological or environmental concern or which are present in quantities greater than 1 g/kg in the active substance, safener or synergist as manufactured, shall have been validated and shown to be sufficiently specific, correctly calibrated, accurate and precise.
Analizne metode aktivne snovi, varovala ali sinergista, kakor se proizvaja, in metode določitve nečistoč, ki so toksikološko, ekotoksikološko ali okoljsko nevarne ali so prisotne v količinah, večjih od 1 g/kg v aktivni snovi, varovalu ali sinergistu, kakor se proizvaja, so bile potrjene in so se izkazale za dovolj specifične, pravilno umerjene, pravilne in natančne.
The methods of residue analysis for the active substance and relevant metabolites in plant, animal and environmental matrices and drinking water, as appropriate, shall have been validated and shown to be sufficiently sensitive with respect to the levels of concern.
Analizne metode ostankov za aktivno snov in relevantne metabolite v rastlinskih, živalskih in okoljskih matrikah ter pitni vodi, kakor je primerno, so bile potrjene in so se izkazale za dovolj občutljive v zvezi s stopnjo nevarnosti.
The evaluation has been carried out in accordance with the uniform principles for evaluation and authorisation of plant protection products referred to in Article 29(6).
Ocena je bila izvedena v skladu z enotnimi načeli za oceno in registracijo fitofarmacevtskih sredstev iz člena 29(6).
Impact on human health
Vpliv na zdravje ljudi
Where relevant, an ADI, AOEL and ARfD shall be established.
Kjer je to ustrezno, se določijo ADI, AOEL in ARfD.
When establishing such values an appropriate safety margin of at least 100 shall be ensured taking into account the type and severity of effects and the vulnerability of specific groups of the population.
Pri določanju teh vrednosti se zagotovi ustrezen varnostni razpon v višini vsaj 100 ob upoštevanju vrste in resnosti učinkov ter ranljivosti posebnih skupin prebivalstva.
When the critical effect is judged of particular significance, such as developmental neurotoxic or immunotoxic effects, an increased margin of safety shall be considered, and applied if necessary.
Kadar se presoja o kritičnem učinku posebnega pomena, kakršni so razvojni nevrotoksični ali imunotoksični učinki, se preuči in po potrebi uporabi večji varnostni razpon.
An active substance, safener or synergist shall only be approved if, on the basis of assessment of higher tier genotoxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as mutagen category 1A or 1B.
Aktivna snov, varovalo ali sinergist se odobri le, če na podlagi ocene testov višjega reda genotoksičnosti v skladu z zahtevami po podatkih o aktivnih snoveh, varovalih ali sinergistih, ter drugih razpoložljivih podatkov in informacij, vključno s pregledom znanstvenih publikacij, ki jih preveri Agencija, v skladu z določbami Uredbe (ES) št. 1272/2008 ni ali ne bo razvrščena kot mutagena skupine 1A ali 1B.
An active substance, safener or synergist shall only be approved, if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances, safener or synergist and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005.
Aktivna snov, varovalo ali sinergist se odobri le, če na podlagi ocene testov rakotvornosti, izvedenih v skladu z zahtevami po podatkih o aktivnih snoveh, varovalih ali sinergistih, ter drugih razpoložljivih podatkov in informacij, vključno s pregledom strokovne literature s strani Agencije, ni ali ne bo razvrščena v skladu z določbami Uredbe (ES) št. 1272/2008 kot rakotvorna skupine 1A ali 1B, razen če je izpostavljenost ljudi tej aktivni snovi, varovalu ali sinergistu v fitofarmacevtskem sredstvu v realnih predlaganih pogojih uporabe zanemarljiva; tj. sredstvo se uporablja v zaprtih sistemih ali v drugih pogojih, kjer ni stika z ljudmi in kjer ostanki zadevne aktivne snovi, varovala ali sinergista v hrani ali krmi ne presegajo privzete vrednosti v skladu s točko (b) člena 18(1) Uredbe (ES) št. 396/2005.
An active substance, safener or synergist shall only be approved if, on the basis of assessment of reproductive toxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005.
Aktivna snov, varovalo ali sinergist se odobri le, če na podlagi ocene testov strupenosti za razmnoževanje, izvedenih v skladu z zahtevami po podatkih o aktivnih snoveh, varovalih ali sinergistih, ter drugih razpoložljivih podatkov in informacij, vključno s pregledom strokovne literature s strani Agencije, ni ali ne bo razvrščena v skladu z določbami Uredbe (ES) št. 1272/2008 kot strupena za razmnoževanje skupine 1A ali 1B, razen če je izpostavljenost ljudi tej aktivni snovi, varovalu ali sinergistu v fitofarmacevtskem sredstvu v realnih predlaganih pogojih uporabe zanemarljiva; tj. sredstvo se uporablja v zaprtih sistemih ali v drugih pogojih, kjer ni stika z ljudmi in kjer ostanki zadevne aktivne snovi, varovala ali sinergista v hrani ali krmi ne presegajo privzete vrednosti v skladu s točko (b) člena 18(1) Uredbe (ES) št. 396/2005.
An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not considered to have endocrine disrupting properties that may cause adverse effect in humans, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005.
Aktivna snov, varovalo ali sinergist se odobri le, če se na podlagi ocene smernic Skupnosti ali mednarodno priznanih smernic za preskušanje ali drugih razpoložljivih podatkov in informacij, vključno s pregledom strokovne literature s strani Agencije, šteje, da nima lastnosti motilcev hormonskega ravnovesja, ki lahko škodljivo vplivajo na ljudi, razen če je izpostavljenost ljudi tej aktivni snovi, varovalu ali sinergistu v fitofarmacevtskem sredstvu v realnih predlaganih pogojih uporabe zanemarljiva; tj. sredstvo se uporablja v zaprtih sistemih ali v drugih pogojih, kjer ni stika z ljudmi in kjer ostanki zadevne aktivne snovi, varovala ali sinergista v hrani ali krmi ne presegajo privzete vrednosti v skladu s točko (b) člena 18(1)) Uredbe (ES) št. 396/2005.
By 14 December 2013, the Commission shall present to the Standing Committee on the Food Chain and Animal Health a draft of the measures concerning specific scientific criteria for the determination of endocrine disrupting properties to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
Komisija do 14. decembra 2013 predloži Stalnemu odboru za prehranjevalno verigo in zdravje živali osnutek ukrepov, ki zadevajo posebna znanstvena merila za določitev lastnosti motilcev hormonskega ravnovesja, ki se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 79(4).
Pending the adoption of these criteria, substances that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogenic category 2 and toxic for reproduction category 2, shall be considered to have endocrine disrupting properties.
Do sprejetja teh meril se za snovi, ki so ali še morajo biti razvrščene v skladu z določbami iz Uredbe (ES) št. 1272/2008 kot rakotvorne skupine 2 in strupene za razmnoževanje skupine 2, šteje, da imajo lastnosti motilcev hormonskega ravnovesja.
In addition, substances such as those that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 2 and which have toxic effects on the endocrine organs, may be considered to have such endocrine disrupting properties.
Poleg tega se lahko za snovi, kot so na primer snovi, ki so ali še morajo biti razvrščene v skladu z določbami iz Uredbe (ES) št. 1272/2008 kot strupene za razmnoževanje skupine 2 in ki imajo toksične učinke na organe z notranjim izločanjem, šteje da imajo take lastnosti motilcev hormonskega ravnovesja.
Fate and behaviour in the environment
Usoda in obnašanje v okolju
An active substance, safener or synergist shall only be approved where it is not considered to be a persistent organic pollutant (POP).
Aktivna snov, varovalo ali sinergist se odobri le, če ne šteje za obstojno organsko onesnaževalo (POP).
A substance that fulfils all three of the criteria of the points below is a POP.
Snov, ki izpolnjuje vsa tri spodaj navedena merila, je POP.
An active substance, safener or synergist fulfils the persistence criterion where there is evidence that the time it takes for a degradation of 50 % (DT50) in water is greater than 2 months, or that its DT50 in soil is greater than 6 months, or that its DT50 in sediment is greater than 6 months.
Aktivna snov, varovalo ali sinergist izpolnjuje merilo za obstojnost, kjer je razvidno, da je čas razgradnje 50 % (DT50) v vodi daljši od dveh mesecev ali da je njegov DT50 v tleh daljši od šestih mesecev ali da je njegov DT50 v usedlini daljši od šestih mesecev.
An active substance, safener or synergist fulfils the bioaccumulation criterion where there is:
Aktivna snov, varovalo ali sinergist izpolnjuje merilo za bioakumulacijo, kjer je:
evidence that its bio-concentration factor or bioaccumulation factor in aquatic species is greater than 5000 or, in the absence of such data, that the partition coefficient n-octanol/water (log Ko/w) is greater than 5, or
dokaz, da je njegov faktor bio-koncentracije ali faktor bioakumulacije v vodnih vrstah večji od 5000 ali, če ni takšnih podatkov, da je koeficient partiticije n-oktanol/voda (log Ko/w) večji od 5, ali