natgillin/translations-raw huggingface dataset:
2.1 Določbe iz člena 7(1) 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 rab.
2.1 Article 7(1) 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.
2.1 Določbe iz člena 7(1) so izpolnjene le, če se na podlagi predložene dokumentacije pričakuje, da bo registracija v vsaj eni državi članici mogoča za vsaj tri fitofarmacevtska sredstva , ki vsebujejo zadevno aktivno snov, za celoten obseg reprezentativnih rab.
2.1 Article 7(1) 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 three plant protection products containing that active substance for the full range of representative uses.
Priloga II, točka 3.2
Annex II, point 3.2
Aktivna snov se odobri le, če je bilo za omejen obseg reprezentativnih rab ugotovljeno, da je fitofarmacevtsko sredstvo po uporabi v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih običajnih pogojev uporabe dovolj učinkovito.
An active substance shall only be approved where it has been established for a limited range of representative uses that the plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic normal conditions of use is sufficiently effective.
Ta zahteva se oceni glede na enotna načela za oceno in registracijo fitofarmacevtskih sredstev iz drugega odstavka člena 35.
This requirement shall be evaluated in the light of the uniform principles for evaluation and authorisation of plant protection products referred to in the second paragraph of Article 35.
Aktivna snov se odobri le, če je bilo za velik obseg reprezentativnih rab ugotovljeno, da je fitofarmacevtsko sredstvo po uporabi v skladu z dobro prakso uporabe fitofarmacevtskih sredstev in ob upoštevanju realnih pogojev uporabe dovolj učinkovito.
An active substance shall only be approved where it has been established for an extensive range of representative uses that the plant protection product, consequent on application consistent with good plant protection product practice and having regard to realistic conditions of use, is sufficiently effective.
Vsaka odločitev mora temeljiti na realnih pogojih uporabe.
Any decision must be based on realistic conditions of use.
Priloga II, točka 3,6
Annex II, point 3.6
Če je to ustrezno, se določijo SDV, DRII in ARO.
Where relevant, an ADI, AOEL and ARfD shall be established.
Pri določanju teh vrednosti se zagotovi zadostna meja varnosti, ob upoštevanju vrste in resnosti učinkov ter ranljivosti posebnih skupin prebivalstva.
When establishing such values a sufficient safety margin 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 primerna meja varnosti najmanj 100 , ob upoštevanju vrste in resnosti učinkov , možnih kombiniranih učinkov ter ranljivosti posebnih skupin prebivalstva, kot so ženske v rodni dobi, zarodki, plodovi in otroci do konca pubertete.
When establishing such values an appropriate safety margin of at least 100 shall be ensured taking into account the type and severity of effects, possible combination effects and the vulnerability of specific groups of the population particularly at risk, such as professional users, women of reproductive age, embryos, foetuses and children up to the end of puberty .
Aktivna snov se odobri le, če na podlagi ocene večjih preskušanj genostrupenosti, izvedenih v skladu z zahtevami po podatkih o aktivnih snoveh in fitofarmacevtskih sredstvih ter drugih razpoložljivih podatkov in informacij , ni razvrščena, v skladu z določbami Direktive 67/548/EGS, kot mutagena kategorija 1 ali 2 , razen če je izpostavljenost človeka tej aktivni snovi v fitofarmacevtskem sredstvu v realnih predlaganih pogojih uporabe zanemarljiva .
An active substance 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 and the plant protection products and other available data and information, it is not classified, in accordance with the provisions of Directive 67/548/EEC, as mutagen category 1 or 2 unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use is negligible.
Aktivna snov se odobri le, če na podlagi ocene večjih preskušanj genostrupenosti, izvedenih v skladu z zahtevami po podatkih o aktivnih snoveh in fitofarmacevtskih sredstvih ter drugih razpoložljivih podatkov in informacij, kar vključuje pregled znanstvenih publikacij, ni ali ne bo razvrščena, v skladu z določbami Direktive 67/548/EGS, kot mutagena kategorija 1 ali 2.
An active substance 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 and the plant protection products and other available data and information including a review of the scientific literature , it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as a mutagen category 1 or 2 .
Takšne aktivne snovi se odobrijo samo, če se izpostavljenost človeka tej aktivni snovi v fitofarmacevtskem sredstvu v realnih pogojih uporabe lahko izključi (npr. pri uporabi pasti z vabo).
Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic conditions of use , can be excluded (e.g. by use in bait traps) .
Aktivna snov se odobri le, če na podlagi ocene preskušanj rakotvornosti, izvedenih v skladu z zahtevami po podatkih o aktivnih snoveh in fitofarmacevtskih sredstvih ter drugih razpoložljivih podatkov in informacij, ni in ne bo razvrščena, v skladu z določbami Direktive 67/548/EGS, kot rakotvorna kategorija 1 ali 2, razen če je izpostavljenost človeka tej aktivni snovi v fitofarmacevtskem sredstvu v realnih predlaganih pogojih uporabe zanemarljiva .
An active substance 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 and the plant protection products and other available data and information, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as carcinogen category 1 or 2 unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use is negligible.
Aktivna snov se odobri le, če na podlagi ocene večjih preskušanj rakotvornosti, izvedenih v skladu z zahtevami po podatkih o aktivnih snoveh in fitofarmacevtskih sredstvih ter drugih razpoložljivih podatkov in informacij, kar vključuje pregled znanstvenih publikacij, ni ali ne bo razvrščena, v skladu z določbami Direktive 67/548/EGS, kot rakotvorna kategorija 1 ali 2.
An active substance 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 and the plant protection products and other available data and information including a review of the scientific literature , it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as a carcinogen category 1 or 2 .
Takšne aktivne snovi se odobrijo samo, če se izpostavljenost človeka tej aktivni snovi v fitofarmacevtskem sredstvu v realnih pogojih uporabe lahko izključi (npr. pri uporabi pasti z vabo).
Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic conditions of use , can be excluded (e.g. by use in bait traps).
Aktivna snov se odobri le, če na podlagi ocene preskušanj strupenosti za razmnoževanje, izvedenih v skladu z zahtevami glede podatkov o aktivnih snoveh in fitofarmacevtskih sredstvih ter drugih razpoložljivih podatkov in informacij, ni in ne bo razvrščena, v skladu z določbami Direktive 67/548/EGS, kot strupena za razmnoževanje iz kategorije 1 ali 2 , razen če je izpostavljenost človeka tej aktivni snovi v fitofarmacevtskem sredstvu v realnih predlaganih pogojih uporabe zanemarljiva .
An active substance 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 and the plant protection products and other available data and information, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as toxic for reproduction category 1 or 2 unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use is negligible.
Aktivna snov se odobri le, če na podlagi ocene večjih preskušanj strupenosti za razmnoževanje, izvedenih v skladu z zahtevami po podatkih o aktivnih snoveh in fitofarmacevtskih sredstvih ter drugih razpoložljivih podatkov in informacij, kar vključuje pregled znanstvenih publikacij, ni ali ne bo razvrščena, v skladu z določbami Direktive 67/548/EGS, kot strupena za razmnoževanje iz kategorije 1 ali 2.
An active substance 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 and the plant protection products and other available data and information including a review of the scientific literature , it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as toxic for reproduction category 1 or 2 .
Aktivna snov se odobri le, če na podlagi ocene v skladu s smernicami Skupnosti za preskušanje ali z mednarodno priznanimi smernicami za preskušanje ni ugotovljeno, da ima lastnosti endokrinih motilcev hormonov, ki imajo lahko toksikološki pomen v zvezi z ljudmi , razen če je izpostavljenost človeka tej aktivni snovi v fitofarmacevtskem sredstvu v realnih predlaganih pogojih uporabe zanemarljiva .
An active substance shall only be approved, if, on the basis of the assessment of Community or internationally agreed test guidelines it is not considered to have endocrine disrupting properties that may be of toxicological significance in humans unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use , is negligible.
Aktivna snov se odobri le, če na podlagi ocene v skladu s smernicami Skupnosti za preskušanje ali z mednarodno priznanimi smernicami za preskušanje ali drugimi razpoložljivimi podatki in informacijami, kar vključuje pregled znanstvenih publikacij, ni ugotovljeno, da ima lastnosti endokrinih motilcev hormonov, za katere obstaja sum, da imajo toksikološki pomen v zvezi z ljudmi , tudi kadar obstaja verjetnost za izpostavljenost med življenjem zarodka/plodu in/ali v otroštvu, ob upoštevanju morebitnih kombinacij učinkov .
An active substance 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 it is not considered to have endocrine disrupting properties that are suspected to be of toxicological significance in humans including when exposure is likely to happen during embryonic/foetal life and/or during childhood, taking due account of likely combination effects.
Aktivna snov se odobri le, če se na podlagi ocene ali drugih razpoložljivih podatkov in informacij, kar vključuje pregled znanstvenih publikacij, ne ugotovi, da ima nevrotoksične ali imunotoksične učinke na ljudi, ob upoštevanju izpostavljenosti med življenjem zarodka/plodu in/ali v otroštvu ter morebitnih kombinacij učinkov.
An active substance shall only be approved if, on the basis of the assessment or other available data and information including a review of the scientific literature, it is not considered to have neurotoxic or immunotoxic properties in humans, taking into account exposure during embryonic/foetal life and/or during childhood as well as likely combination effects.
Takšne aktivne snovi se odobrijo samo, če se izpostavljenost človeka tej aktivni snovi v fitofarmacevtskem sredstvu v realnih pogojih uporabe lahko izključi (npr. pri uporabi pasti z vabo).
Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic conditions of use, can be excluded (e.g. by use in bait traps).
V skladu s previdnostnim načelom bi bilo treba pri določanju meril za izključitev kroničnih učinkov na zdravje upoštevati oceno tveganja, ne pa jih povezovati z oceno izpostavljenosti.
According to the precautionary principle, cut off criteria for chronic health effects should be set at the level of hazard assessment and should not be related to exposure assessment.
To je potrebno, ker „realno predlagani pogoji“ niso opredeljeni.
This is so because there is no definition for “realistic proposed conditions”.
Tudi druga omejitvena merila izključujejo dele strategije za oceno tveganja, na primer omejitvena merila za zelo obstojne in bioakumulativne snovi.
Other cut off criteria also exclude parts of the risk assessment strategy, for example the cut off criteria for vPvB.
Pesticidov, razvrščenih v kategorijo 3, se ne sme odobriti, dokler ni znanstveno dokazano, da nimajo morebitnih rakotvornih, reproduktivno toksičnih ali mutagenih lastnosti.
CRM pesticides which are classified in category 3 should not be approved until scientific results prove they do not have potential carcinogenic, reprotoxic or mutagenic effects.
Priloga II, točka 3.7.1, uvod in točki (a) in (b)
Annex II, point 3.7.1, introduction and points (a) and (b)
Aktivna snov se odobri le, če se ne šteje za obstojno organsko onesnaževalo .
An active substance shall only be approved where it is not considered to be a persistent organic pollutant .
Aktivna snov se odobri le, če se snov sama, njeni produkti presnove ali ostanki ne štejejo za obstojna organska onesnaževala .
An active substance shall only be approved where it, and its transformation products or residues, are not considered to be persistent organic pollutants .
Obstojno organsko onesnaževalo je opredeljeno na naslednji način:
A persistent organic pollutant is defined as follows:
(i) dokaz, da je njegov DT50 v vodi daljši od dveh mesecev ali da je njegov DT50 v zemlji daljši od šestih mesecev ali da je njegov DT50 v usedlini daljši od šestih mesecev; in
(i) Evidence that its DT50 in water is greater than two months, or that its DT50 in soil is greater than six months, or that its DT50 in sediment is greater than six months; and
(i) dokaz, da je njegov DT50 v vodi daljši od dveh mesecev ali da je njegov DT50 v zemlji daljši od šestih mesecev ali da je njegov DT50 v usedlini daljši od šestih mesecev;
(i) Evidence that its DT50 in water is greater than two months, or that its DT50 in soil is greater than six months, or that its DT50 in sediment is greater than six months;
(ia) dokaz, da je aktivna snov sicer dovolj obstojna, da je njena izključitev iz Priloge I Direktive 91/414/EGS upravičena ali zahteva obravnavo z vidika konvencije o obstojnih organskih onesnaževalih; ali
(ia) Evidence that the active substance is otherwise sufficiently persistent to justify its exclusion from Annex I to Directive 91/414/EEC, or to be considered in the context of the POPs Convention; or
(i) dokaz, da je njegov faktor koncentracije ali faktor kopičenja v vodnih vrstah večji od 5 000 ali, če ni takšnih podatkov, da je vrednost log Ko/w večja od 5;
(i) Evidence that its bio-concentration factor or bio accumulation factor in aquatic species is greater than 5,000 or, in the absence of such data, that the log Ko/w is greater than 5;
(i) dokaz, da je njegov faktor koncentracije ali faktor kopičenja v vodnih vrstah večji od 2 000 ali, če ni takšnih podatkov, da je vrednost log Ko/w večja od 5;
(i) Evidence that its bio-concentration factor or bio accumulation factor in aquatic species is greater than 2,000 or, in the absence of such data, that the log Ko/w is greater than 5;
(ii) dokaz, da kemikalija predstavlja druge razloge za nevarnost, kot je visoka stopnja kopičenja v drugih neciljnih vrstah, visoka toksičnost ali ekotoksičnost; in
(ii) Evidence that a chemical presents other reasons for concern, such as high bio-accumulation in other non-target species, high toxicity or ecotoxicity; and
(ii) dokaz, da kemikalija predstavlja druge razloge za nevarnost, kot je visoka stopnja kopičenja v drugih neciljnih vrstah, visoka toksičnost ali ekotoksičnost; ali
(ii) Evidence that a chemical presents other reasons for concern, such as high bio-accumulation in other non-target species, high toxicity or ecotoxicity; or
(iia) spremljanje podatkov v živih organizmih, ki kažejo, da je zmožnost bioakumulacije aktivne snovi dovolj velika, da zahteva obravnavo z vidika konvencije o obstojnih organskih onesnaževalih; ali
(iia) Monitoring data in biota indicating that the bio-accumulation potential of the active substance is sufficient to be considered under the POPs Convention; or
Ta predlog spremembe uredbo usklajuje s prilogo D stockholmske konvencije.
This amendment brings the Regulation in line with Annex D of the Stockholm Convention.
Vsa tri merila za obstojna organska onesnaževala bi se morala uporabljati kot posamezna merila za izključitev.
The three POP-criteria should be individually cut-off criteria.
Poleg tega se teh meril ne bi smelo razveljaviti z izračuni izpostavljenosti ali drugimi pogoji in ocenami.
In addition, these criteria should not be overruled by calculations on exposure or other conditions and estimates.
Priloga II, točka 3.7.2, uvod, pododstavek 1
Annex II, point 3.7.2, introduction, subparagraph 1
Aktivna snov se odobri le, če se ne šteje za obstojno in strupeno snov, ki se kopiči v organizmih (PBT).
An active substance shall only be approved if it is not considered to be a persistent, bioaccumulating and toxic (PBT) substance.
Aktivna snov in njeni produkti presnove ali ostanki se odobrijo le, če se ne štejejo za obstojno in strupeno snov, ki se kopiči v organizmih (PBT).
An active substance shall only be approved if it, and its transformation products or residues, are not considered to be persistent, bioaccumulating and toxic (PBT) substances .
Merila v predlogu Komisije so prevzeta iz uredbe REACH, čeprav so bile njihove pomanjkljivosti ugotovljene že v omenjeni uredbi in bodo merila v roku enega leta pregledana.
The criteria in the Commission proposal are taken from REACH, even though the deficiency of those criteria has already been acknowledged within REACH, as they are subject to a review within 1 year.
Merila za snovi, ki se kopičijo v organizmih (PBT) ter zelo obstojne in bioakumulativne snovi, navedena v uredbi REACH, so tako toga, da po njih ni mogoče določiti niti dobro znanih snovi PBT, kot so navedene v stockholmski konvenciji o obstojnih organskih onesnaževalih.
The REACH criteria for PBT and vPvB substances are so rigid that even well-known PBT substances, such as e.g. those listed by the Stockholm Convention on persistent organic pollutants, are not identified.
V skladu z določbami konvencije je pomembno omogočiti uporabo enakovrednega dokaza in ne samo rezultatov izbirnih testov, ki pogosto niso na voljo ali celo niso uporabni.
In line with the provisions of that Convention, it is important to allow the use of equivalent evidence and not just tick-box test results that are often not available or not even applicable.
Priloga II, točka 3.7.2.1, pododstavek 2 a (novo)
Annex II, point 3.7.2.1, subparagraph 2 a (new)
Prav tako izpolnjuje merilo obstojnosti, če obstaja dokaz, da je snov sicer dovolj obstojna, da zbuja skrb:
It also fulfils the persistence criterion where there is evidence that the substance is otherwise sufficiently persistent to be of concern.
Glej obrazložitev k predlogu spremembe točke 3.7.2.
See the justification to the amendment to point 3.7.2.
Priloga II, točka 3.7.2.2, pododstavek 2 a (novo)
Annex II, point 3.7.2.2, subparagraph 2 a (new)
Prav tako izpolnjuje merilo za bioakumulacijo, če obstaja dokaz za visoko bioakumulacijo v drugih vrstah, ali če spremljanje podatkov v živih organizmih nakazuje, da je zmožnost bioakumulacije kemikalije dovolj velika, da zbuja skrb;
It also fulfils the bioaccumulation criterion when there is evidence of high bioaccumulation in other species, or monitoring data in biota indicate that the bioaccumulation potential of the chemical is sufficient to be of concern .
Priloga II, točka 3.7.2.3, alinea 2
Annex II, point 3.7.2.3, indent 2
– je snov razvrščena kot rakotvorna (kategorije 1 ali 2), mutagena (kategorije 1 ali 2), ali reproduktivno toksična (kategorije 1, 2 ali 3) ali
- the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2, or 3), or
– je snov razvrščena kot rakotvorna (kategorija 1, 2 ali 3 ), mutagena (kategorija 1, 2 ali 3 ), ali strupena za razmnoževanje (kategorija 1, 2 ali 3) ali
- the substance is classified as carcinogenic (category 1, 2 or 3 ), mutagenic (category 1, 2 or 3 ), or toxic for reproduction (category 1, 2, or 3), or
Priloga II, točka 3.7.3, uvod, pododstavek 1
Annex II, point 3.7.3, introduction, subparagraph 1
Aktivna snov ne izpolnjuje določb iz člena 4, če je zelo obstojna in je bioakumulacija zelo velika (vPvB).
An active substance shall not be considered as complying with Article 4 where it is very persistent, very bioaccumulating (vPvB).
Aktivna snov in njeni produkti presnove ali ostanki ne izpolnjujejo določb iz člena 4, če so zelo obstojni in je bioakumulacija zelo velika (vPvB).
An active substance shall not be considered as complying with Article 4 where it, or its transformation products or residues, are very persistent, very bioaccumulating (vPvB).
Priloga II, točka 3.7.3.1
Annex II, point 3.7.3.1.
Aktivna snov izpolnjuje merilo velike obstojnosti, če:
An active substance fulfils the very persistence criterion where:
Aktivna snov izpolnjuje merilo visoke obstojnosti (vP-), če obstaja dokaz, da :
An active substance fulfils the very persistent criterion (vP-) where there is evidence that:
– razpolovna doba v morski ali sladki vodi ali v rečnih ustjih traja več kot 60 dni ali
- the half-life in marine, fresh- or estuarine water is higher than 60 days, or
– razpolovna doba v sedimentu morske, sladke vode ali rečnih ustjih traja več kot 180 dni ali
- the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or
– razpolovna doba v zemlji traja več kot 180 dni.
- the half-life in soil is higher than 180 days.
Prav tako izpolnjuje merilo visoke obstojnosti, če obstaja dokaz, da je snov sicer dovolj obstojna, da zbuja skrb:
It also fulfils the very persistent criterion where there is evidence that the substance is otherwise sufficiently highly persistent to be of concern.
Glej obrazložitev k predlogu spremembe točke 3.7.3.
See the justification to the amendment to point 3.7.3.
Priloga II, točka 3.7.3.2, pododstavka 1 a in 1 b (novo)
Annex II, point 3.7.3.2., subparagraphs 1 a and 1 b (new)
Ocena bioakumulacije temelji na izmerjenih podatkih o koncentraciji v vodnih vrstah.
Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species.
Lahko se uporabijo podatki o sladkovodnih in morskih vrstah.
Data from both freshwater and marine water species can be used.
Prav tako izpolnjuje merilo visoke obstojnosti, če obstaja dokaz o visoki bioakumulaciji v drugih vrstah, ali če spremljanje podatkov v živih organizmih, kaže, da je zmožnost bioakumulacije kemikalije dovolj velika, da zbuja skrb:
It also fulfils the very bioaccumulative criterion when there is evidence of very high bioaccumulation in other species, or monitoring data in biota indicate that the bioaccumulation potential of the chemical is sufficient to be of concern.