natgillin/translations-raw huggingface dataset:
– je ali mora biti na podlagi ocene preskušanj rakotvornosti, izvedenih v skladu z zahtevami po podatkih o aktivnih snoveh in fitofarmacevtskih sredstvih ter drugih razpoložljivih podatkov in informacij, 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, ali
– on the basis of an 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 or has 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, or
– 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);
– je ali mora biti na podlagi ocene preskušanj strupenosti za razmnoževanje, izvedenih v skladu z zahtevami po podatkih o aktivnih snoveh in fitofarmacevtskih sredstvih ter drugih razpoložljivih podatkov in informacij, 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, ali
– on the basis of an 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 or has 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, or
– vsebuje velik delež neaktivnih izomerov.
– it contains a significant proportion of non-active isomers.
– velja za obstojno bioakumulativno in strupeno snov (PBT).
– it is considered to be a persistent, bioaccumulating and toxic (PBT) substance.
Ocena obstojnosti v okolju temelji na razpoložljivih podatkih o razpolovni dobi, ki so zbrani v skladu z ustreznimi pogoji, ki jih opiše vlagatelj.
Assessment of persistence in the environment shall be based on available half-life data collected under approp ria te conditions, which shall be described by the applicant.
– obstajajo drugi dokazi kronične strupenosti, kot opredeljujejo klasifikacije: T, R48, ali Xn, R48 po Direktivi 67/548/EGS ali
– there is other evidence of chronic toxicity, as identified by the classifications: T, R48 or Xn, R48 pursuant to Directive 67/548/EEC, or
– je zelo obstojna in je bioakumulacija zelo velika (vPvB).
– it is very persistent, very bioaccumulating (vPvB).
Aktivna snov izpolnjuje merilo velike obstojnosti, če:
An active substance fulfils the very persistent criterion where:
The ‘candidate for substitution’ criteria currently used in the draft regulation have little or no correlation to real risks arising from the use of plant protection products .
The ‘candidate for substitution’ criteria currently used in the draft regulation have little or no correlation to real risks arising from the use of plant protection products .
MNENJE Odbora za kmetijstvo in razvoj podeželja (*)
OPINION of the COMMITTEE ON AGRICULTURE AND RURAL DEVELOPMENT (*)
Predlagana uredba o dajanju fitofarmacevtskih sredstev v promet nadomešča predvsem Direktivo 91/414/ES.
The proposal for a regulation concerning the placing of plant protection products on the market shall essentially replace Directive 91/414/EC.
V njej so predvideni vseevropska registracija (ali v primeru pomožnih snovi v formulaciji prepoved) aktivnih snovi in drugih sestavin (varoval (pozitivni seznam), sinergistov (pozitivni seznam), pomožnih snovi v formulaciji (negativni seznam)) fitofarmacevtskih sredstev, registracija fitofarmacevtskih sredstev na nacionalni ravni skupaj s poenostavitvijo vzajemnega priznavanja na novih zemljepisnih območjih, primerjalne ocene fitofarmacevtskih sredstev, ki vsebujejo pogojno nevarne snovi, nova pravila za uporabo v manjši meri, nova pravila za varstvo podatkov in zaupnost ter nova pravila za vodenje evidenc o prodaji in uporabi.
It envisages a European wide authorisation (or European wide prohibition in the case of Co-Formulants) of the active substance and other contents (Safeners (positive list), Synergists (positive list), Co-Formulants (negative list)) of plant protection products (PPP), a national authorisation of the PPPs combined with easier mutual recognition within newly created geographical zones, a comparative assessment of PPP that contain substances of concern, new rules for minor uses, new rules for data-protection and confidentiality as well as new rules on documentation of sales and use.
Čeprav lahko fitofarmacevtska sredstva škodujejo zdravju ljudi in okolju, so za zagotavljanje proizvodnje kakovostnih kmetijskih izdelkov po dostopnih cenah nedvomno nepogrešljiva.
Though PPPs can have negative effects on human health and the environment, there is no doubt that PPPs are essential to assure the production of quality farm products at affordable prices.
Za učinkovito varstvo pred škodljivci potrebujemo široko paleto varnih kemičnih izdelkov.
A wide range of safe chemical products is needed for effective pest control.
Fitofarmacevtska sredstva igrajo pomembno vlogo v vseh strategijah Skupnosti, ki zagotavljajo zdravje rastlin in učinkovito uporabo omejenih virov, kot so tla.
PPPs play an essential part in any Community strategy to assure plant health and efficient use of limited resources such as soil.
Postopek registracije, ki je potreben v kmetijstvu, mora:
Agriculture does need an authorisation procedure that
· biti predvidljiv,
· is predictable,
· dajati zanesljive rezultate,
· provides reliable results,
· preprečevati, da se varni izdelki zgolj zaradi postopkovnih razlogov ne bi pojavljali na trgu,
· does not keep safe products from entry into the market for procedural reasons only,
· voditi v večjo usklajenost pri dajanju fitofarmacevtskih sredstev v promet,
· leads to more harmonization in placing plant protection products on the market,
· upoštevati potrebo po posebnih pravilih za uporabo v manjši meri,
· takes the need for specific rules for minor uses into account ,
· ustvarjati enake konkurenčne pogoje v Evropi in
· creates a level playing field for farmers in Europe and
· s tem zmanjševati uradno nezakonito prakso (trgovine in uporabe) v Evropi.
· thereby minimizing formally illegal practices (trade and use) in Europe.
Poročevalec podpira splošno usmerjenost pristopa Komisije k poenostavitvi priznavanja in razpoložljivosti preverjenih, varnih in okolju prijaznejših fitofarmacevtskih sredstev na danem območju, prvi uskladitvi registracije neaktivnih snovi, priznavanju potrebe po posebnih pravilih za uporabo v manjši meri in poenostavitvi postopka registracije.
The rapporteur supports the general line of the Commission´s approach to facilitate the recognition and availability of tested, safe and more environment-friendly PPPs within a given zone, to harmonize the authorisation of the non-active substances for the first time, to recognize the need for specific rules on minor uses and to render the authorisation procedure more comprehensive.
Ne glede na to predlaga spremembe zaradi racionalizacije postopka registracije s skrajšanjem rokov, ki imajo zgolj postopkovni značaj.
Nevertheless the rapporteur proposes changes to streamline the authorisation procedure by cutting back on deadlines of purely procedural character.
V nasprotju s Komisijo tudi predlaga ohranitev pravil za začasno registracijo iz Direktive 91/414/ES, zato da so varni in inovativni izdelki kmetom čim prej na voljo, ter uvedbo pravil za vzporedni uvoz zaradi nadaljnje uskladitve postopka registracije.
He also proposes, contrary to the Commission, to retain the rules of Directive 91/414/CE on provisional authorisation to make safe and innovative products available to farmers as soon as possible, as well as to introduce rules on parallel imports for further harmonization of the authorisation procedure.
Poročevalec tudi predlaga, da se poenostavi medobmočno priznavanje fitofarmacevtskih sredstev, hkrati pa državam članicam dovoli, da v skladu z različnimi vzorci uporabe določijo zanjo dodatne pogoje itd.
The rapporteur also proposes to facilitate interzonal recognition of PPP, while allowing the Member States to impose additional conditions of use according to different use-patterns etc.
S predlaganimi spremembami pri registraciji fitofarmacevtskih sredstev za uporabo v manjši meri naj bi države članice, Komisijo in družbe spodbudili k večjim vlaganjem na tem področju.
Changes in the authorisation of PPP for minor use are proposed as to encourage Member States, the Commission and companies to invest more in this field.
Registracija fitofarmacevtskih sredstev bi morala temeljiti na pristopu, pri katerem bi se upoštevalo tveganje, ki je pri določeni snovi zelo odvisno od odmerka, ukrepov za omejevanje škodljivih vplivov in naravnega okolja.
Authorisation of PPP should be based on a risk based approach as the risk linked to a specific substance may vary considerably to dosage, mitigation measures and natural environment.
Iz tega bi morala biti izvzeta uvedba omejitvenih meril.
The introduction of Cut-off-criteria should be an exception.
Zato poročevalec predlaga spremembo značaja večine omejitvenih meril, ki jih je predlagala Komisija, in njihovo uporabo kot osnovo za opredelitev nekaterih snovi kot "pogojno nevarnih", ki jih je treba primerjalno oceniti.
The rapporteur therefore proposes to change the character of most cut-off criteria as proposed by the Commission and to take them as a basis for classifying certain substances as "substances of concern" which have to undergo comparative assessment.
Obdobje registracije bi moralo biti za pogojno nevarne snovi enako kot za druge snovi, saj je obvezen poseben nadzor in se lahko registracijo kadar koli prekliče.
The authorisation period for substances of concern should be the same as for other substances as a specific monitoring is obligatory and the authorisation may be withdrawn at any time as it is.
Za trajnostno in učinkovito varstvo pred škodljivci potrebujemo nove in inovativne izdelke.
New and innovative products are needed for sustainable and effective pest control.
Novi izdelki se bodo proizvajali le, če bodo znanstvena dognanja podjetij, ki pri razvoju sodelujejo, ustrezno zaščitena.
New products will only be produced if the scientific knowledge of companies involved in research is adequately protected.
Odvečna opredelitev dobre okoljske prakse in vrsta rokov za izpolnitev spremenljivih načel integriranega varstva rastlin pred škodljivci, so bili črtani.
The superfluous definition of good environmental practice and a set deadline for compliance with the volatile principles of integrated pest management were deleted.
Poročevalec je poskusil olajšati kmetom birokratsko breme.
The rapporteur has tried to ease the bureaucratic burden on farmers.
Ker se veliko število izvedbenih pravil določi v postopku komitologije, so za lajšanje administrativnega bremena kmetov pristojne predvsem države članice in Komisija.
As a great number of implementation rules are left to comitology, responsibility for easing the administrative burden of farmers will lie mainly with the Member States and the Commission.
Ker predlagana pravila za komitologijo ne ustrezajo zadnjim dogovorom med Svetom, Evropskim parlamentom in Komisijo, poročevalec poziva odgovorni odbor, naj ta vidik podrobneje preuči.
As the proposed comitology rules do not comply with the latest agreements of Council, European Parliament and Commission the rapporteur asks the lead committee to take a closer look at this aspect.
Odločitve zakonodajne narave ne bi smele biti prepuščene zgolj Komisiji.
Decisions of legislative character should not be left to the Commission alone.
(6a) Različne vrste kultur so v Skupnosti pomembne za proizvodnjo v večjem in manjšem obsegu.
(6a) Various types of crop are of significance in the Community for both large-scale and small-scale production.
(8) Namen te uredbe je zagotoviti visoko raven varstva zdravja ljudi , živali in okolja ter hkrati zagotoviti konkurenčnost evropskega kmetijstva .
(8) The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment , and at the same time to ensure the competitiveness of European agriculture .
Sprejeti ukrepi in odločitve ne smejo škoditi konkurenčnosti kmetijstva Skupnosti na svetovnem trgu.
The measures and decisions adopted must not prove detrimental to the competitiveness of Community agriculture on the world market.
(9) Snovi se vključijo v fitofarmacevtska sredstva le na podlagi dokazov, da nedvomno koristijo rastlinski pridelavi , in se ne pričakuje, da bi škodljivo vplivale na zdravje ljudi ali živali ter okolje .
(9) Substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and they are not expected to have any harmful effect on human or animal health or any unacceptable influence on the environment.
(9) Snovi se vključijo v fitofarmacevtska sredstva le na podlagi dokazov, da nedvomno koristijo rastlinski pridelavi in da ne snovi ne njihovi ostanki ne škodijo zdravju ljudi ali živali ter okolju .
(9) Substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and that neither they nor their residues can have any harmful effect on human or animal health or any unacceptable influence on the environment.
Včasih so ostanki škodljivešji od snovi samih, zato je treba preučiti njihov vpliv na ljudi, živali in okolje.
The effects of the residues on human and animal health and the environment must therefore be researched.
Po prvi obnovitvi odobritve je treba takšne snovi ponovno pregledati le, če obstajajo dokazi, da ne izpolnjujejo več zahtev te uredbe .
After the first renewal, such substances should only be reviewed further where there are indications that they no longer meet the requirements of this Regulation.
Po prvi obnovitvi odobritve je treba pripraviti program za redne ponovne odobritve teh snovi .
After the first renewal, a programme for the regular renewal of these substances should be put in place .
Predlog spremembe zagotavlja reden pregled novih in starih snovi s pozitivnega seznama iz leta 1991 (priloga I k direktivi 91/414) in da se upoštevajo njihova tveganja.
This amendment guarantees that both new and old substances that have been included in the positive list from 1991 on (Annex 1 to Directive 91/414) are re-examined regularly, and their risks borne in mind.
Zato je treba, preden se fitofarmacevtska sredstva dajo v promet, dokazati, da nedvomno koristijo rastlinski pridelavi ter nimajo škodljivega vpliva na zdravje ljudi ali živali ter okolje .
Therefore, it should be demonstrated, before plant protection products are placed on the market, that they present a clear benefit for plant production and do not have any harmful effect on human or animal health or any unacceptable influence on the environment .
Zlasti pri registraciji fitofarmacevtskih sredstev mora biti cilj zagotavljanja varstva zdravja ljudi ali živali in okolja pomembnejši kot cilj izboljšanja rastlinske pridelave.
In particular, when granting authorisations of plant protection products, the objective of protecting human or animal health and the environment should take priority over the objective of improving plant production.
Zato je treba, preden se fitofarmacevtska sredstva dajo v promet, dokazati, da nimajo škodljivega vpliva na zdravje ljudi ali živali ter okolje in da nedvomno koristijo rastlinski pridelavi v zadevnem geografskem območju .
Therefore, it should be demonstrated, before plant protection products are placed on the market, that they do not have any harmful effect on human or animal health or on the environment and that they genuinely present a clear benefit for plant production in the geographical area concerned.
(22a) Za optimalno zatiranje škodljivcev morajo biti na voljo različna in varna fitofarmacevtska sredstva, zato mora biti postopek registracije čim krajši.
(22a) Availability of different and safe plant protection products is necessary for optimal pest management.
Začasno registracijo je treba ohraniti, pravila za vzporedni uvoz pa uskladiti.
The authorisation procedure should therefore be as quick as possible.
(24) Za preprečitev podvajanja dela, zmanjšanje upravnega bremena za industrijo in države članice ter za zagotovitev bolj usklajene dostopnosti do fitofarmacevtskih sredstev morajo registracije , ki jih izda ena država članica, sprejeti tudi druge države članice , v katerih so ekološke in podnebne razmere primerljive .
(24) To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to ensure more harmonised availability of plant protection products, authorisations granted by one Member State should be accepted by other Member States where ecological and climatic conditions are comparable.
(24) Za preprečitev podvajanja dela, zmanjšanje upravnega bremena za industrijo in države članice ter za zagotovitev bolj usklajenega dostopa do fitofarmacevtskih sredstev morajo odločbe o registraciji , ki jih izda ena država članica, sprejeti tudi druge države članice s primerljivimi ekološkimi in podnebnimi razmerami .
(24) To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to ensure more harmonised availability of plant protection products, authorisations granted by one Member State should be accepted by other Member States where ecological and climatic conditions are comparable.
Zato je treba Evropsko unijo razdeliti na območja s primerljivimi razmerami , v katerih je uporaba dovoljena, da se doseže resnično vzajemno priznavanje.
Therefore, the European Union should be divided in authorisation zones with comparable conditions in order to achieve genuine mutual recognition.
Za končno vzpostavitev delujočega notranjega trga fitofarmacevtskih sredstev je potreba vseevropska registracija.
EU-wide authorisation is required in order, finally, to establish a functioning internal market for plant protection products.
Pri postopku registracije je treba upoštevati tudi dodatne pogoje in omejitve uporabe (npr. omejitev glede razdalje, začasna prepoved uporabe itd.).
The authorisation procedure should also take account of additional conditions and restrictions on use (e.g. distance restrictions, prohibiting use at certain times, etc.).
(24a) Vzajemno priznavanje na danem območju pospešuje in poenostavlja postopek registracije fitofarmacevtskih sredstev.
(24a) Mutual recognition within a given zone accelerates and facilitates the authorisation procedure for plant protection products.
Ker se lahko vzorci uporabe in naravni pogoji na nekem območju razlikujejo, je treba državam članicam dovoliti, da predpisujejo posebne pogoje uporabe.
As use patterns and natural conditions may vary within a zone Member States should be entitled to impose specific conditions for use.
Od držav članic se ne sme zahtevati, da priznajo preklic registracije, ki ga zahteva država članica na istem območju, če lahko dokažejo, da pogoji na njihovem območju dovoljujejo varno uporabo.
Member States should not be obliged to recognise the withdrawal of an authorisation by a Member State in the same zone if they can prove that conditions in their territory allow safe use.
Sodelovati morajo na vseh stopnjah postopkov za registracijo fitofarmacevtskega sredstva.
Member States should cooperate in all phases of procedures for authorisation, of a plant protection product.
(24b) Delitev držav na območja, v katerih je uporaba dovoljena, je prvi korak k vzpostavitvi celostnega notranjega trga fitofarmacevtskih sredstev, kjer registracija fitofarmacevtskega sredstva velja po vsej EU.
(24b) Dividing Member States into authorisation zones is regarded as the first step towards establishing an integrated internal market for plant protection products on which authorisation of a plant protection product is valid throughout the EU.
Prvi korak v tej smeri bi lahko bila registracija po območjih, kjer bi registracija fitofarmacevtskega sredstva v eni državi določenega območja veljala za vse države istega območja.
Zonal authorisation, under which authorisation of a plant protection product in one Member State within a particular zone would be valid for all Member States in that zone can be a first step towards that.
Svet vključi načela načel integriranega varstva rastlin pred škodljivci, vključno z dobro prakso varstva rastlin in dobro okoljsko prakso, v predpisane zahteve ravnanja iz Priloge III k Uredbi št. 1782/2003.
The Council shall include in the statutory management requirement referred to in Annex III of Regulation (EC) No 1782/2003 the principles of integrated pest management, including good plant protection practice and good environmental practice.
Zato je treba predvideti prehodno obdobje, v katerem bodo države članice lahko vzpostavile potrebne strukture, da se uporabnikom fitifarmacevtskih sredstev omogoči uporaba načel integriranega varstva rastlin pred škodljivci.
A transitional period should therefore be foreseen to allow Member States to put in place the necessary structures to enable users of plant protection products to apply the principles of integrated pest management.
Zavrne se uvedba novih zahtev navzkrižne skladnosti.
The introduction of new cross-compliance obligations is rejected.
(37a) Izvajalci morajo imeti enake možnosti dostopa do trga, omogočiti je treba zlasti dejavnost malih in srednje velikih podjetij, da se kmetom zagotovi razpoložljivost dovolj varnih in učinkovitih fitofarmacevtskih sredstev.
(37a) Operators must have the same opportunities in respect of market access, in particular so that small and medium-sized enterprises can operate, in order to ensure that sufficient safe and effective plant protection products are available to farmers.
(38) Uredba (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora, da se zagotovi preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali, predvideva nadzorne ukrepe za uporabo fitofarmacevtskih sredstev na vseh stopnjah proizvodnje živil, če se fitofarmacevtska sredstva v proizvodnji živil uporabljajo posredno, vključno z vodenjem evidence o uporabi fitofarmacevtskih sredstev.
(38) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules provides for control measures for the use of plant protection products at all stages of the production of food, in so far as plant protection products are used directly in food production, including record keeping on the use of plant protection products.
Uredba (ES) št. 882/2004 ne obravnava fitofarmacevtskih sredstev.
Regulation (EC) No 882/2004 has nothing to do with plant protection products.
Namen te uredbe je zagotoviti visoko raven varstva zdravja ljudi in živali ter okolja.
The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment.