natgillin/translations-raw huggingface dataset:
Priloga II, točka 3.8.1
Annex II, point 3.8.1
Aktivna snov se šteje za skladno s členom 4 le, če ocena tveganja kaže tveganja, ki so sprejemljiva v skladu z merili, določenimi v enotnih načelih za oceno in registracijo fitofarmacevtskih sredstev iz člena 35, pod realnimi predlaganimi pogoji uporabe fitofarmacevtskega sredstva, ki vsebuje aktivno snov.
An active substance shall only be considered as complying with Article 4 if the risk assessment demonstrates risks to be acceptable in accordance with the criteria laid down in the uniform principles for evaluation and authorisation of plant protection products referred to in Article 35 under realistic proposed conditions of use of a plant protection product containing the active substance.
Ocena mora upoštevati resnost učinkov, nezanesljivost podatkov in število skupin organizmov, za katere se pričakuje, da bo nameravana uporaba aktivne snovi nanje škodljivo vplivala.
The assessment must take into account the severity of effects, the uncertainty of the data, and the number of organism groups which the active substance is expected to affect adversely by the intended use.
Ocena mora upoštevati resnost učinkov na biološko raznovrstnost , nezanesljivost podatkov in število skupin organizmov, za katere se pričakuje, da bo nameravana uporaba aktivne snovi nanje škodljivo vplivala.
The assessment must take into account the severity of effects on biodiversity , the uncertainty of the data, and the number of organism groups which the active substance is expected to affect adversely by the intended use.
Dolgoročna ohranitev biološke raznovrstnosti mora biti eden osnovnih ciljev uredbe.
The long-term conservation of biodiversity must be one of the basic objectives of the Regulation.
Priloga II, točka 3.8.2
Annex II, point 3.8.2
Aktivna snov se šteje za skladno s členom 4 le, če na podlagi ocene Skupnosti ali mednarodno priznanih smernic za preskušanje ni ugotovljeno, da ima lastnosti endokrinih motilcev hormonov, ki imajo lahko toksikološki pomen v zvezi z neciljnimi organizmi , razen če je izpostavljenost neciljnega organizma tej aktivni snovi v fitofarmacevtskem sredstvu v realnih predlaganih pogojih uporabe zanemarljiva .
An active substance shall only be considered as complying with Article 4 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 on non-target organisms unless the exposure of non-target organisms to that active substance in a plant protection product, under realistic proposed conditions of use is negligible .
Aktivna snov se šteje za skladno s členom 4 le, če na podlagi ocene Skupnosti ali mednarodno priznanih smernic za preskušanje ali drugih razpoložljivih podatkov in informacij, kar vključuje pregled znanstvenih publikacij, ni ugotovljeno, da ima lastnosti endokrinih motilcev hormonov, ki imajo verjetno toksikološki pomen v zvezi z neciljnimi organizmi.
An active substance shall only be considered as complying with Article 4 if, on the basis of the assessment of Community or internationally agreed test guidelines and other available data and information, including a review of the scientific literature , it is not considered to have endocrine disrupting properties that are likely to be of toxicological significance on non-target organisms.
V skladu s previdnostnim načelom meril za izključitev za kronične učinke ne bi smeli povezovati samo z oceno izpostavljenosti, tudi zato ker ni obvezujoče opredelitve „realno predlaganih pogojev uporabe“.
According to the precautionary principle, cut off criteria for chronic effects should not be related only to exposure assessment, also because there is no binding definition for “realistic proposed conditions of use”.
Ta odstavek je treba uskladiti s pogoji za odobritev aktivnih snovi v zvezi z zdravjem ljudi, pri čemer se poleg rezultatov ocene upoštevajo „drugi razpoložljivi podatki in informacije“.
It is necessary to bring this paragraph in line with the conditions for approval of active substances in relation to human health considering “other available data and information” in addition to the results of the assessment.
Priloga II, točka 3.8.2 a (novo)
Annex II, point 3.8.2 a (new)
Aktivna snov se odobri le, če na podlagi ocene Skupnosti ali mednarodno priznanih smernic za preskušanje ter drugih razpoložljivih podatkov in informacij, kar vključuje pregled znanstvenih publikacij, ni ugotovljeno, da je toksična za čebele in ima koeficient tveganja (HQ) nižji od 50.
An active substance shall only be approved, if, on the basis of the assessment of Community or internationally agreed test guidelines and other available data and information including a review of the scientific literature, it is not considered to be toxic for bees and has a Hazard Quotient (HQ) lower than 50.
Študije so pokazale, da čebele, ki so bile izpostavljene pesticidom, izgubijo sposobnost orientacije.
Studies have revealed that bees which have been exposed to pesticides suffer loss of orientation.
Pri postopku odobritve je treba upoštevati toksičnost za čebele.
Bee toxicity shall be taken into account in the approval process.
Koeficient tveganja (HQ) je zelo koristen kazalec pri izračunu toksičnosti za čebele in ga je treba pri oceni tveganja upoštevati.
The Hazard Quotient (HQ) is a very useful indicator to calculate toxicity to bees and should therefore be taken explicitly into consideration in the risk assessment.
Priloga II, točka 3.9
Annex II, point 3.9
Aktivna snov se odobri le, če se lahko , kadar je to ustrezno, določi opredelitev ostanka za namene ocene tveganja in za namene izvrševanja.
An active substance shall only be approved if , where relevant, a residue definition can be established for the purposes of risk assessment and for enforcement purposes.
Aktivna snov se odobri le, če se lahko določi opredelitev ostanka in če jo je mogoče odkriti z analitičnimi metodami za splošno rabo za namene ocene tveganja in za namene izvrševanja.
An active substance shall only be approved if a residue definition can be established and analytical methods in general use are capable of detecting them for the purposes of risk assessment and for enforcement purposes.
Predlog spremembe dopolnjuje člen z dvema razsežnostima.
This amendment introduces two dimensions into this article.
Prvič, za vse registrirane pesticide obstaja opredelitev ostanka.
Firstly that for all authorised pesticides there shall be a residue definition.
Drugič, standardna laboratorijska oprema mora omogočati identifikacijo in merjenje ostankov vseh snovi na trgu, kar trenutno ni izvedljivo.
Secondly, that standard laboratory equipment should be capable of identifying and measuring residues of all substances in the market which is currently not the case.
S standardno laboratorijsko opremo je mogoče identificirati samo približno 100 snovi, medtem ko je na trgu precej večje število snovi, ki so trenutno „nevidne“ za namene izvrševanja in spremljanja.
Standard laboratory equipment is capable of detecting just over 100 substances when there are many more substances in the market that are currently “invisible” for the purposes of enforcement and monitoring.
Priloga II, točka 3.9 a (novo)
Annex II, point 3.9 a (new)
Učinki prehranjevalne verige
Food-chain effects
Aktivna snov se odobri le, če se njen učinek na prehranjevalno verigo višjih organizmov šteje za sprejemljivega na podlagi znanstveno odobrene metodologije ocene tveganja, in če je odobrena, se ocenjeni učinek na ekosistem zmanjšuje s sistemom ublažitve in nadomeščanja.
An active substance shall only be approved if its impact on the food chain of higher organisms is considered to be acceptable on the basis of a scientifically approved risk assessment methodology and, if approved, the assessed impact on the ecosystem is reduced through a system of mitigation and compensation.
Veliko pesticidov ima posredne učinke na ekosistem, na primer preko prehranjevalne verige (manjša populacija ptic v kmetijskih ekosistemih zaradi množičnega zmanjšanja mrčesa).
Many pesticides have indirect effects on the ecosystem, e.g. through food chain effects (reduced bird population in agro-ecosystems due to massive reduction of prey insects).
Te učinke je mogoče oceniti z znanstveno metodologijo, opisano v: Butler SJ, Vickery JA & Norris K (2007): Farmland biodiversity and the footprint of agriculture.
These effects can be assessed using a scientific methodology described in: Butler SJ, Vickery JA & Norris K (2007): Farmland biodiversity and the footprint of agriculture.
Priloga II, točka 3.9 b (novo)
Annex II, point 3.9 b (new)
Izključitev prednostnih snovi
Exclusion of priority substances
Snovi iz prednostnega seznama, ki je bil sestavljen v skladu z ustreznimi mednarodnimi pogodbami, ki jih je ratificirala Evropska unija, ali s seznama prednostnih snovi na področju vodne politike iz priloge Direktive 2000/60/ES, se ne odobrijo.
Substances on a priority list established under relevant international treaties ratified by the European Union, or on the list of priority substances for water policy annexed to Directive 2000/60/EEC, should not be approved.
Predlog spremembe uredbo usklajuje z obstoječo zakonodajo in z okvirno direktivo o vodah.
This amendment brings the Regulation in line with existing legislation and in coherence with the Water Framework Directive
Priloga II, točka 4
Annex II, point 4
Aktivna snov se odobri kot možna nadomestna snov v skladu s členom 24, če:
An active substance shall be approved as a candidate for substitution pursuant to Article 24 where:
Aktivna snov se določi kot snov, ki jo je treba nadomestiti, v skladu s členom 24, če je izpolnjen eden naslednjih pogojev :
An active substance shall be defined as a candidate for substitution pursuant to Article 24 where any of the following conditions are met :
- so njene vrednosti SDV, ARO ali DRII bistveno nižje od vrednosti večine odobrenih aktivnih snovi;
- its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances;
- so njene vrednosti SDV, ARO ali DRII nižje od vrednosti večine odobrenih aktivnih snovi , ob upoštevanju bližnjih stanovalcev, navzočih oseb in najbolj ogroženih skupin prebivalstva ;
- its ADI, ARfD or AOEL is lower than those of the majority of the approved active substances , taking into account residents, bystanders and the most vulnerable population groups;
- izpolnjuje dve merili , ki opredeljujeta snov z lastnostmi PBT;
- it meets two of the criteria to be considered as a PBT substance;
- izpolnjuje eno od meril , ki opredeljujejo snov z lastnostmi PBT;
- it meets one of the criteria to be considered as a PBT substance;
- zlahka uhaja v podtalnico;
- it is prone to leaching to groundwater;
- obstajajo razlogi za skrb v zvezi z naravo kritičnih učinkov , ki skupaj z vzorci uporabe/izpostavljenosti povzročijo primere uporabe, ki lahko še vedno zbujajo skrb, kljub zelo omejevalnim ukrepom za obvladovanje tveganja (kot so obsežna osebna zaščitna oprema ali zelo široki varovalni pasovi);
- there are reasons for concern linked to the nature of the critical effects which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, even with very restrictive risk management measures(such as extensive personal protective equipment or very large buffer zones);
- obstajajo razlogi za skrb v zvezi z naravo kritičnih učinkov in lastnostmi, ki lahko privedejo do zelo omejevalnih ukrepov za obvladovanje tveganja (kot so obsežna osebna zaščitna oprema ali zelo široki varovalni pasovi);
- there are reasons for concern linked to the nature of the critical effects and properties which may give rise to very restrictive risk management measures (such as extensive personal protective equipment or very large buffer zones);
- na podlagi ocene ali drugih razpoložljivih podatkov in informacij, kar vključuje pregled znanstvenih publikacij, povzroča endokrine motnje in kaže nevrotoksične ali imunotoksične učinke pri odraslih ali v razvojni dobi;
- it has potentially endocrine disrupting, neurotoxic or immunotoxic properties, in adults or during development, on the basis of assessment and other available data and information including a review of scientific literature;
– vsebuje velik delež neaktivnih izomerov.
- it contains a significant proportion of non-active isomers.
Snovi, ki dokazano povzročajo endokrine motnje, ali imajo nevrotoksične ali imunotoksične učinke, se ne odobrijo.
Substances which provide evidence of endocrine disruption, neurotoxic or immunotoxic properties shall not be approved.
Snovi, pri katerih obstaja možnost takšnih učinkov, vendar ti niso jasno dokazani, zlasti kadar pride do izpostavljenosti med razvojem, se obravnavajo kot snovi, ki jih je treba nadomestiti.
Substances which have a potential, but no clear evidence, for such properties, especially when exposure occurs during development, should be considered as candidates for substitution.
Posebna pozornost se nameni razvojnim nevrotoksičnim učinkom.
Special attention shall be given to developmental neurotoxic effects.
Priloga II a
Annex II a
Seznam aktivnih snovi, ki so odobrene za vključitev med fitofarmacevtska sredstva
List of active substances approved for inclusion in plant protection products
Treba je ohraniti vključitev odobrenih snovi v prilogi uredbe.
The inclusion of approved substances in an Annex of the Regulation should be maintained
Seznam pomožnih snovi v formulaciji, ki niso odobrene za vključitev v fitofarmacevtska sredstva
List of co-formulants which are not accepted for inclusion in plant protection products
Seznam pomožnih snovi v formulaciji, varoval in sinergistov, ki so odobrene za vključitev v fitofarmacevtska sredstva
List of co-formulants, safeners and synergists approved for inclusion in plant protection products
Pomožne snovi v formulaciji lahko vplivajo na zdravje ljudi in okolje.
Co-formulants can have an impact on human health and the environment.
Zato jih je treba odobriti in vključiti v pozitivni seznam.
They should therefore be approved and included in a positive list.
Primerjalno oceno izvedejo države članice, kadar ocenjujejo zahtevek za registracijo fitofarmacevtskega sredstva, ki vsebuje aktivno snov, odobreno kot možno nadomestno snov .
A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product containing an active substance approved as a candidate for substitution.
Primerjalno oceno izvedejo države članice, kadar ocenjujejo zahtevek za registracijo fitofarmacevtskega sredstva.
A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product.
Pri tem imajo prednost fitofarmacevtska sredstva, ki vsebuje aktivno snov, odobreno kot snov, ki jo je treba nadomestiti .
In this process, priority shall be given to plant protection products containing an active substance approved as a candidate for substitution.
Če se obravnava zavrnitev ali preklic registracije fitofarmacevtskega sredstva v korist nadomestnega fitofarmacevtskega sredstva (v nadaljevanju „nadomestna snov“), mora nadomestno sredstvo ob upoštevanju znanstvenih in tehničnih dosežkov pokazati bistveno manjše tveganje za zdravje ali okolje.
Where refusal or withdrawal of an authorisation of a plant protection product in favour of an alternative plant protection product is considered (hereinafter ‘substitution’), the alternative must, in the light of scientific and technical knowledge, show significantly lower risk to health or the environment.
Ocena nadomestnega fitofarmacevtskega sredstva se izvede, da se dokaže, ali se lahko uporablja s podobnimi učinki na ciljni organizem ter brez bistvene gospodarske in praktične izgube za uporabnika.
An assessment of the alternative plant protection product shall be performed to demonstrate whether it can be used with similar effect on the target organism and without significant economic and practical disadvantages to the user or not.
Dodatni pogoji za zavrnitev ali preklic registracije so:
Further conditions for refusal or withdrawal of an authorisation are:
(a) nadomestna snov se uporabi le, če je kemijska raznolikost aktivnih snovi zadostna za čim večje zmanjšanje nastanka odpornosti v ciljnem organizmu;
(a) substitution shall be applied only where the chemical diversity of the active substances is sufficient to minimise the occurrence of resistance in the target organism;
(a) nadomestna snov se uporabi le, če raznolikost aktivnih snovi in drugih nekemičnih metod za zaščito kulturnih rastlin in zatiranje škodljivcev zadostuje za čim večje zmanjšanje nastanka odpornosti v ciljnem organizmu;
(a) substitution shall be applied only where the diversity of the active substances and other non-chemical methods of crop protection and pest prevention is sufficient to minimise the occurrence of resistance in the target organism;
(b) nadomestna snov se uporabi le pri aktivnih snoveh, ki povzročajo, če se uporabljajo v registriranih fitofarmacevtskih sredstvih, bistveno višjo raven tveganja za zdravje ljudi ali okolje;
(b) substitution shall be applied only to active substances which, where used in authorised plant protection products, present a significantly higher level of risk to human health or the environment;
(b) nadomestna snov se v državah članicah lahko uporabi pri vseh aktivnih snoveh, ki povzročajo, če se uporabljajo v registriranih fitofarmacevtskih sredstvih, višjo raven tveganja za zdravje ljudi ali okolje.
(b) substitution may be applied by Member States to all active substances which, where used in authorised plant protection products, present a higher level of risk to human health or the environment.
(c) nadomestna snov se uporabi šele po tem, ko se po potrebi omogoči pridobivanje praktičnih izkušenj, če še niso na voljo .
( c) substitution shall be applied only after allowing for the possibility, where necessary, of acquiring experience from use in practice, where not already available.
Državam članicam ni treba odobriti proizvodov, ki ne vsebujejo snovi, ki jo je treba nadomestiti, če so na trgu varnejše drugačne možnosti.
Even products that do not contain a candidate for substitution might not be approved by Member States if there are safer alternatives in the market.
Države članice morajo imeti pravico dopolniti sedanji seznam EU snovi, ki jih je treba nadomestiti, če to želijo zaradi varstva zdravja ljudi in okolja.
Member States should be entitled to go beyond the current EU list of candidates for substitution if they wish so on the basis of the protection of human health and the environment.
Pri primerjalni oceni in nadomestitvi je treba dati prednost snovem, ki naj bi jih nadomestili.
Priority in comparative assessment and substitution shall however be given to candidates for substitution.
Pri primerjalni oceni se upoštevajo nekemične metode in prakse gojenja pridelkov in preprečevanja škodljivcev.
Non-chemical methods and practises of crop management and pest prevention shall be taken into account in the comparative assessment.
Priloga IV, točka 2
Annex IV, point 2
Občutne razlike v tveganju za vsak primer posebej opredelijo pristojni organi.
A significant difference in risk shall be identified on a case-by-case basis by the competent authorities.
Upoštevajo se lastnosti aktivne snovi in možnost izpostavljenosti različnih podskupin prebivalstva (uporabniki strokovnjaki in uporabniki nestrokovnjaki, navzoče osebe, delavci, prebivalci, posebne ranljive skupine ali potrošniki) neposredno ali posredno preko hrane, krme, vode ali okolja.
The properties of the active substance, and the possibility of exposure of different population subgroups (professional or non-professional users, bystanders, workers, residents, specific vulnerable groups or consumers) directly or indirectly through food, feed, water or the environment shall be taken into account.
Upoštevati je treba tudi druge dejavnike, kot sta strogost uvedenih omejitev uporabe in predpisana osebna zaščitna oprema.
Other factors such as the stringency of imposed restrictions on use and prescribed personal protective equipment must also be considered.
V zvezi z okoljem se za občutno razliko v tveganju šteje faktor z vrednostjo najmanj 10 med deležem predvidene koncentracije v okolju (PEC) in deležem predvidene koncentracije brez učinka (PNEC) različnih aktivnih snovi.
For the environment, a factor of at least 10 between the Predicted Environmental Concentration (PEC) and the Predicted No Effect Concentration (PNEC) ratios of different active substances is considered a significant difference in risk.
V zvezi z okoljem se ob upoštevanju ugotovljenih kumulativnih in sinergijskih učinkov za občutno razliko v tveganju šteje faktor z vrednostjo najmanj 3 med deležem predvidene koncentracije v okolju (PEC) in deležem predvidene koncentracije brez učinka (PNEC) različnih aktivnih snovi.
For the environment, taking into account known cumulative and synergistic effects , a factor of at least 3 between the Predicted Environmental Concentration (PEC) and the Predicted No Effect Concentration (PNEC) ratios of different active substances is considered a significant difference in risk.
Treba je upoštevati kombinacije učinkov pesticidov.
Combination effects of pesticides must be taken into account.
Faktor 10 med deležem predvidene koncentracije v okolju (PEC) in deležem predvidene koncentracije brez učinka (PNEC) bi po nepotrebnem omejil število možnih nadomestnih snovi.
A factor 10 between PEC and PNEC would unnecessarily restrict the number of substances which are candidates for substitution.
Priloga IV, točka 3, pododstavek 2 a (novo)
Annex IV, point 3, subparagraph 2 a (new)
Primerjalna ocena upošteva dovoljeno uporabo v manjši meri.
The comparative assessment shall take authorised minor uses into account.
Evropski parlament, Evropska komisija in Svet so s sprejetjem 6. okoljskega akcijskega programa priznali, da je treba nadalje zmanjšati učinek pesticidov na zdravje ljudi in okolje.
With the adoption of the 6 th Environment Action Programme, the European Parliament, the European Commission and the Council acknowledged that the effect of pesticides on human health and the environment must be diminished still further.
Poudarili so potrebo po okolju prijaznejši uporabi pesticidov in se zavzemajo za dvotirni pristop: polno izvajanje in primerna presoja veljavnega pravnega okvira ter razvoj tematske strategije trajnostne rabe pesticidov.
They stress the necessity for environmentally sustainable management of pesticides and advocate a two-pronged approach with full implementation and appropriate review of the existing legal framework, together with the development of a thematic strategy for the sustainable deployment of pesticides.
Pričujoči predlog Komisije, ki je rezultat še nedokončane revizije Direktive 91/414, mora po mnenju poročevalke izhajati iz utemeljitev 6. okoljskega akcijskega programa.
The present Commission proposal, which is a result of the continuing revision of Directive 91/414, should, in the view of the rapporteur, be guided by the reasons behind the 6 th Environment Action Programme.
Nadaljnji cilj je udejanjanje aktualnih spoznanj iz prospektivnih in retrospektivnih strategij ocene tveganj in nevarnosti za ljudi in okolje ter uskladitev z ostalimi področji politike.
The aim should also be to implement current knowledge of prospective and retrospective strategies for assessing the risks and dangers to humans and the environment and to create coherency with other policies.
Uredba naj bi v skladu s cilji 6. okoljskega akcijskega programa ter tematsko strategijo trajnostne rabe pesticidov zagotovila visoko raven varstva zdravja ljudi in okolja.
In line with the objectives of the 6 th Environment Action Programme and the Thematic Strategies for the sustainable use of pesticides, the regulation must guarantee a high level of protection for human health and the environment.
Zato se mora po mnenju poročevalke opirati na na člen 152(4)(b) in člen 175 Pogodbe ES, previdnostno načelo pa mora imeti prednost pred drugimi interesi.
In the view of the rapporteur, paragraphs 152(4)b and 175 of the EC Treaty should therefore be taken as the basis, and the precautionary principle should be given precedence over other interests.