natgillin/translations-raw huggingface dataset:
The technical rules necessary for the evaluation of such substances should be established.
Določiti bi bilo treba tehnična pravila, potrebna za oceno takšnih snovi.
Substances currently on the market should only be evaluated after those rules have been established.
Snovi, ki so zdaj na trgu, bi bilo treba oceniti šele po uvedbi teh pravil.
Plant protection products may also contain co-formulants.
Fitofarmacevtska sredstva lahko vsebujejo tudi dodatke.
It is appropriate to provide a list of co-formulants which should not be included in plant protection products.
Primerno je zagotoviti seznam dodatkov, ki se ne smejo vključiti v fitofarmacevtska sredstva.
Plant protection products containing active substances can be formulated in many ways and used on a variety of plants and plant products, under different agricultural, plant health and environmental (including climatic) conditions.
Fitofarmacevtska sredstva, ki vsebujejo aktivne snovi, so lahko formulirana na različne načine in se lahko uporabljajo na različnih rastlinah in rastlinskih proizvodih, v različnih razmerah na področju kmetijstva, zdravja rastlin in okolja (vključno s podnebjem).
Authorisations for plant protection products should therefore be granted by Member States.
Zato bi morale registracije za fitofarmacevtska sredstva izdajati države članice.
The provisions governing authorisation must ensure a high standard of protection.
Določbe, ki urejajo registracijo, morajo zagotavljati visok standard varstva.
In particular, when granting authorisations of plant protection products, the objective of protecting human and animal health and the environment should take priority over the objective of improving plant production.
Zlasti pri izdaji registracije za fitofarmacevtska sredstva bi moral biti cilj varovanja zdravja ljudi in živali ter okolja pomembnejši kot cilj izboljšanja rastlinske pridelave.
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, including that of vulnerable groups, or any unacceptable effects on the environment.
Še preden se fitofarmacevtska sredstva dajo v promet bi zato bilo treba dokazati, da nedvomno koristijo rastlinski pridelavi in nimajo nobenega škodljivega vpliva na zdravje ljudi ali živali, vključno na zdravje ranljivih skupin, ali nobenega nesprejemljivega vpliva na okolje.
In the interest of predictability, efficiency and consistency, criteria, procedures and conditions for the authorisation of plant protection products should be harmonised, account being taken of the general principles of protection of human and animal health and the environment.
Zaradi predvidljivosti, učinkovitosti in usklajenosti bi bilo treba merila, postopke in pogoje za registracijo fitofarmacevtskih sredstev uskladiti, ob upoštevanju splošnih načel varstva zdravja ljudi in živali ter varovanja okolja.
Where the decision on approval cannot be finalised within the period provided for due to reasons not falling under the responsibility of the applicant, Member States should be able to grant the provisional authorisations for a limited period in order to facilitate the transition to the approval procedure provided for under this Regulation.
Če sklepa o odobritvi ni mogoče doseči v predvidenem obdobju iz razlogov, ki ne sodijo v odgovornost vlagatelja, bi morale imeti države članice možnost odobriti začasne registracije za omejeno obdobje, da bi se olajšal prehod na postopek odobritve, kakor ga določa ta uredba.
In the light of the experience gained from the approval of the active substances under this Regulation, the provisions on provisional authorisations should cease to apply or be extended after the period of five years, if necessary.
Glede na izkušnje, dobljene pri odobritvi aktivnih snovi v skladu s to uredbo, bi morale po petih letih določbe o začasnih registracijah prenehati veljati ali biti po potrebi podaljšane.
The active substances contained in a plant protection product can be produced by different manufacturing processes, leading to differences in specifications.
Aktivne snovi v fitofarmacevtskem sredstvu se lahko proizvedejo z različnimi proizvodnimi postopki, kar povzroča razlike v specifikacijah.
Such differences may have safety implications.
Te razlike lahko vplivajo na varnost.
For efficiency reasons, a harmonised procedure at Community level should be provided for the assessment of those differences.
Zaradi učinkovitosti bi bilo treba na ravni Skupnosti zagotoviti usklajen postopek za oceno teh razlik.
Good administrative cooperation between Member States should be increased during all steps of the authorisation procedure.
Dobro upravno sodelovanje med državami članicami bi bilo treba okrepiti na vseh stopnjah postopka registracije.
The principle of mutual recognition is one of the means of ensuring the free movement of goods within the Community.
Načelo vzajemnega priznavanja je eno od sredstev za zagotavljanje prostega pretoka blaga v Skupnosti.
To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to provide for more harmonised availability of plant protection products, authorisations granted by one Member State should be accepted by other Member States where agricultural, plant health and environmental (including climatic) conditions are comparable.
Za preprečitev podvajanja dela, zmanjšanje administrativnega bremena za industrijo in države članice ter za zagotovitev bolj izenačene dostopnosti do fitofarmacevtskih sredstev bi morale registracije, ki jih izda ena država članica, sprejeti tudi druge države članice, v katerih so razmere na področju kmetijstva, zdravja rastlin in okolja (vključno s podnebjem) primerljive.
Therefore, the Community should be divided into zones with such comparable conditions in order to facilitate such mutual recognition.
Zato bi bilo treba Skupnost razdeliti na cone s takšnimi primerljivimi razmerami, da se olajša takšno vzajemno priznavanje.
However, environmental or agricultural circumstances specific to the territory of one or more Member States might require that, on application, Member States recognise or amend an authorisation issued by another Member State, or refuse to authorise the plant protection product in their territory, where justified as a result of specific environmental or agricultural circumstances or where the high level of protection of both human and animal health and the environment required by this Regulation cannot be achieved.
Iz okoljskih in kmetijskih razmer na ozemlju ene ali več držav članic bi pa morda lahko izviralo, da države članice ob vložitvi zahtevka priznajo registracijo fitofarmacevtskega sredstva, ki jo je izdala druga država članica, jo spremenijo ali registracije fitofarmacevtskega sredstva na svojem ozemlju ne odobrijo, če je to upravičeno zaradi posebnih okoljskih ali kmetijskih razmer ali če ni mogoče doseči visoke stopnje varstva zdravja ljudi in živali ter varovanja okolja, ki jih določa ta uredba.
It should also be possible to impose appropriate conditions having regard to the objectives laid down in the National Action Plan adopted in accordance with Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve a sustainable use of pesticides [9].
Lahko bi se tudi sprejeli ustrezni pogoji glede ciljev iz nacionalnih akcijskih načrtov, sprejetih v skladu z Direktivo 2009/128/ES Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o določitvi okvira za ukrepe Skupnosti za doseganje trajnostne rabe pesticidov [9].
The economic incentive for industry to apply for an authorisation is limited for certain uses.
Ekonomska spodbuda industrije v zvezi z vlogo za registracijo je omejena na določene vrste uporabe.
In order to ensure that diversification of agriculture and horticulture is not jeopardised by the lack of availability of plant protection products, specific rules should be established for minor uses.
Za zagotovitev, da manjša dostopnost do fitofarmacevtskih sredstev ne ogroža raznovrstnosti kmetijstva ter sadjarstva in vrtnarstva, bi bilo treba za manjše uporabe določiti posebna pravila.
Where identical plant protection products are authorised in different Member States, a simplified procedure for granting a parallel trade permit should be provided for in this Regulation, in order to facilitate the trade between Member States of such products.
V primeru registracije enakih fitofarmacevtskih sredstev v različnih državah članicah bi morala ta uredba zagotoviti poenostavljen postopek za odobritev dovoljenja za vzporedno trgovanje, da bi se olajšalo trgovanje s takšnimi sredstvi med državami članicami.
In exceptional cases, Member States should be permitted to authorise plant protection products not complying with the conditions provided for in this Regulation, where it is necessary to do so because of a danger or threat to plant production or ecosystems which cannot be contained by any other reasonable means.
V izjemnih primerih bi bilo treba državam članicam dovoliti registracijo fitofarmacevtskih sredstev, ki niso v skladu s pogoji iz te uredbe, kadar je to nujno zaradi ogroženosti rastlinske pridelave ali ekosistemov, ki jih ni mogoče obvarovati na drug ustrezen način.
Such temporary authorisations should be reviewed at Community level.
Takšne začasne registracije bi bilo treba pregledati na ravni Skupnosti.
Community seeds legislation provides for free movement of seeds within the Community but does not contain a specific provision concerning seeds treated with plant protection products.
Zakonodaja Skupnosti o semenih zagotavlja prosti pretok semen znotraj Skupnosti, ne določa pa posebnih določb o semenih, tretiranih s fitofarmacevtskimi sredstvi.
Such a provision should therefore be included in this Regulation.
Zato bi takšna določba morala biti vključena v to uredbo.
If treated seeds constitute a serious risk to human or animal health or to the environment, Member States should have the possibility of taking protective measures.
V kolikor tretirana semena resno ogrožajo zdravje ljudi ali živali ali okolje, bi moralo biti državam članicam omogočeno, da sprejmejo zaščitne ukrepe.
To promote innovation, special rules should be established permitting the use of plant protection products in experiments even where they have not yet been authorised.
Za spodbujanje inovacij bi bilo treba določiti posebna pravila, ki dovoljujejo uporabo fitofarmacevtskih sredstev pri preskusih, tudi kadar ta sredstva še niso bila registrirana.
To ensure a high level of protection of human and animal health and the environment, plant protection products should be used properly, in accordance with their authorisation, having regard to the principles of integrated pest management and giving priority to non-chemical and natural alternatives wherever possible.
Za zagotovitev visoke ravni varovanja zdravja ljudi in živali ter varovanja okolja je potrebna pravilna uporaba fitofarmacevtskih sredstev v skladu z njihovo registracijo ter upoštevanje načel integriranega varstva rastlin pred škodljivimi organizmi in dajanje prednosti nekemičnim in naravnim alternativam, kjer je to mogoče.
The Council should include in the statutory management requirement referred to in Annex III to Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers [10], the principles of integrated pest management, including good plant protection practice and non-chemical methods of plant protection and pest and crop management.
Svet bi moral v predpisane zahteve ravnanja iz Priloge III k Uredbi Sveta (ES) št. 1782/2003 z dne 29. septembra 2003 o skupnih pravilih za sheme neposrednih podpor v okviru skupne kmetijske politike in o uvedbi nekaterih shem podpor za kmete [10] vključiti načela integriranega varstva rastlin pred škodljivimi organizmi, vključno z dobro prakso varstva rastlin in nekemičnimi metodami za varstvo rastlin, zatiranje škodljivcev in pridelavo kulturnih rastlin.
In addition to this Regulation and Directive 2009/128/EC, a thematic strategy on the sustainable use of pesticides was adopted.
Poleg te uredbe in Direktive 2009/128/ES je bila sprejeta tudi tematska strategija o trajnostni rabi pesticidov.
In order to achieve coherence between these instruments, the user should know from the product label where, when and under what circumstances a plant protection product may be used.
Za dosego usklajenosti med temi akti bi moral uporabnik z etikete pripravka razbrati, kje, kdaj in pod kakšnimi pogoji se lahko uporablja fitofarmacevtsko sredstvo.
A system of exchange of information should be established.
Vzpostaviti bi bilo treba sistem izmenjave informacij.
Member States should make available to each other, the Commission and the Authority the particulars and scientific documentation submitted in connection with applications for authorisation of plant protection products.
Države članice bi morale drugim državam članicam, Komisiji in Agenciji omogočiti dostop do podrobnosti in znanstvene dokumentacije, ki je bila predložena v zvezi z vlogami za registracijo fitofarmacevtskih sredstev.
Adjuvants may be used to increase the efficacy of a plant protection product.
Za povečanje učinkovitosti fitofarmacevtskih sredstev se lahko uporabijo pomožna sredstva.
Their placing on the market or use should be forbidden where they contain a co-formulant which has been prohibited.
Dajanje v promet ali uporabo teh pomožnih sredstev bi bilo treba prepovedati, če vsebujejo dodatek, ki je prepovedan.
The technical rules necessary for the authorisation should be established.
Določiti bi bilo treba tehnična pravila, potrebna za registracijo.
Studies represent a major investment.
Študije so velika naložba.
This investment should be protected in order to stimulate research.
To naložbo bi bilo treba zaščititi, da se spodbudijo raziskave.
For this reason, tests and studies, other than those involving vertebrate animals, which will be subject to obligatory data sharing, lodged by one applicant with a Member State should be protected against use by another applicant.
Zato je treba preskuse in študije, ki jih vlagatelj predloži državi članici, razen tistih, ki vključujejo poskuse na vretenčarjih, pri katerih je obvezna izmenjava podatkov, zaščititi pred uporabo drugega vlagatelja.
This protection should, however, be limited in time in order to allow competition.
Vendar pa bi ta zaščita morala biti časovno omejena, da se omogoči konkurenca.
It should also be limited to studies which are genuinely necessary for regulatory purposes, to avoid applicants artificially extending the period of protection by submitting new studies which are not necessary.
Prav tako bi morala biti omejena na študije, ki so resnično nujne za regulativne namene, da se prepreči, da bi vlagatelji s predložitvijo novih študij, ki niso nujne, umetno podaljševali obdobje zaščite.
Business operators, in particular small and medium sized enterprises, should have the same opportunities in respect of market access.
Nosilci dejavnosti, zlasti mala in srednja podjetja, bi morali imeti enake možnosti glede dostopa do trga.
The use of non-animal test methods and other risk assessment strategies should be promoted.
Treba je spodbujati uporabo preskusnih metod, pri katerih se ne uporabljajo živali, in drugih strategij za oceno tveganja.
Animal testing for the purposes of this Regulation should be minimised and tests on vertebrates should be undertaken as a last resort.
Preskuse na živalih za potrebe te uredbe je treba čimbolj omejiti, preskusi na vretenčarjih pa morajo biti zadnja možnost.
In accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes [11], tests on vertebrate animals must be replaced, restricted or refined.
V skladu z Direktivo Sveta 86/609/EGS z dne 24. novembra 1986 o približevanju zakonov in drugih predpisov držav članic o varstvu živali, ki se uporabljajo za poskusne in druge znanstvene namene [11], je treba preskuse na vretenčarjih nadomestiti, omejiti ali izpopolniti.
Therefore, rules should be laid down to avoid duplicative testing and duplication of tests and studies on vertebrates should be prohibited.
Zato bi bilo treba določiti pravila za preprečevanje dvojnih preskusov, podvajanje preskusov in študij na vretenčarjih pa bi bilo treba prepovedati.
For the purpose of developing new plant protection products, there should be an obligation to allow access to studies on vertebrates on reasonable terms and the results and the costs of tests and studies on animals should be shared.
Za potrebe razvoja novih fitofarmacevtskih sredstev bi bilo treba sprejeti obveznost, da se pod razumnimi pogoji omogoči dostop do študij o vretenčarjih, rezultate in stroške preskusov in študij na živalih pa bi bilo treba deliti.
In order to allow operators to know what studies have been carried out by others, Member States should keep a list of such studies even where they are not covered by the above system of compulsory access.
Da se omogoči seznanjenost gospodarskih subjektov s tem, katere študije so bile izvedene, bi morale države članice hraniti seznam teh študij, čeprav niso vključene v zgoraj navedeni sistem obveznega dostopa.
As different rules are applied by Member States, the Commission and the Authority in relation to access to and confidentiality of documents, it is appropriate to clarify the provisions concerning access to information contained in the documents in the possession of these authorities and the confidentiality of these documents.
Ker države članice, Komisija in Agencija uporabljajo različne predpise v zvezi z dostopom do dokumentov in zaupnostjo dokumentov, je primerno pojasniti določbe v zvezi z dostopom do informacij iz dokumentov, ki jih imajo ti organi, in zaupnostjo teh dokumentov.
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations [12] applies to the classification, packaging and labelling of plant protection products.
Direktiva 1999/45/ES Evropskega parlamenta in Sveta z dne 31. maja 1999 o približevanju zakonov in drugih predpisov držav članic v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih pripravkov [12] se uporablja za razvrščanje, pakiranje in označevanje pesticidov.
However, to improve further the protection of users of plant protection products, of consumers of plants and plant products and of the environment, further specific rules are appropriate which take account of the specific conditions of use of plant protection products.
Vendar so za nadaljnje izboljšanje varstva uporabnikov fitofarmacevtskih sredstev, potrošnikov rastlin in rastlinskih proizvodov ter okolja primerna dodatna posebna pravila, ki upoštevajo posebne pogoje uporabe fitofarmacevtskih sredstev.
To ensure that advertisements do not mislead users of plant protection products or the public, it is appropriate to lay down rules on the advertising of those products.
Za zagotovitev, da oglasi ne zavajajo uporabnikov fitofarmacevtskih sredstev ali javnosti, je primerno določiti pravila o oglaševanju teh sredstev.
Provisions on record-keeping and information about the use of plant protection products should be established in order to raise the level of protection of human and animal health and the environment by ensuring the traceability of potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality.
Določiti bi bilo treba določbe o vodenju evidence in informacijah o uporabi fitofarmacevtskih sredstev, da se poveča raven varovanja zdravja ljudi in živali ter okolja z zagotovitvijo sledljivosti možne izpostavljenosti, da se poveča učinkovitost spremljanja in nadzora ter zmanjšajo stroški spremljanja kakovosti vode.
Provisions on control and inspection arrangements with regard to the marketing and use of plant protection products should ensure correct, safe and harmonised implementation of the requirements laid down in this Regulation in order to achieve a high level of protection of both human and animal health and the environment.
Določbe o ureditvah o nadzoru in o inšpekcijskih pregledih v zvezi s trženjem in uporabo fitofarmacevtskih sredstev bi morale zagotoviti pravilno, varno in usklajeno izvajanje zahtev iz te uredbe, da se doseže visoka raven varovanja zdravja ljudi in živali ter okolja.
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 [13] provides for control measures for the use of plant protection products at all stages of the production of food, including record-keeping on the use of plant protection products.
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 [13], predvideva nadzorne ukrepe za uporabo fitofarmacevtskih sredstev na vseh stopnjah proizvodnje živil, vključno z vodenjem evidence o uporabi fitofarmacevtskih sredstev.
Similar rules on monitoring and controls relating to the storage and use of plant protection products not covered by Regulation (EC) No 882/2004 should be adopted by the Commission.
Komisija bi morala sprejeti podobna pravila za spremljanje in nadzor v zvezi s skladiščenjem in uporabo fitofarmacevtskih sredstev, ki niso vključena v Uredbo (ES) št. 882/2004.
The bureaucratic burden on farmers should be as limited as possible.
Administrativno breme za kmete bi moralo biti čim manjše.
The measures provided for in this Regulation should apply without prejudice to other Community legislation, in particular Directive 2009/128/EC, Directive 2000/60/EC, Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin [14] and Community legislation on the protection of workers and anyone concerned with the contained use and deliberate release of genetically modified organisms.
Ukrepi iz te uredbe bi se morali uporabljati brez poseganja v preostalo zakonodajo Skupnosti, zlasti v Direktivo 2009/128/ES, Direktivo 2000/60/ES, Uredbo (ES) št. 396/2005 Evropskega parlamenta in Sveta z dne 23. februarja 2005 o mejnih vrednostih ostankov pesticidov v ali na hrani in krmi rastlinskega in živalskega izvora [14] ter zakonodajo Skupnosti o varstvu delavcev in kogar koli v zvezi z omejeno uporabo in namernim sproščanjem gensko spremenjenih organizmov.
It is necessary to establish procedures for the adoption of emergency measures in situations where an approved active substance, a safener, a synergist or a plant protection product is likely to constitute a serious risk to human or animal health or the environment.
Vzpostaviti je treba postopke za sprejetje izrednih ukrepov, kadar je verjetno, da odobrena aktivna snov, varovalo, sinergist ali fitofarmacevtsko sredstvo predstavlja resno tveganje za zdravje ljudi ali živali ali okolje.
Member States should lay down rules on penalties applicable to infringements of this Regulation and should take the measures necessary to ensure that they are implemented.
Države članice bi morale določiti pravila za kazni, ki veljajo za kršitve te uredbe, in z ustreznimi ukrepi zagotoviti, da se izvajajo.
General civil and criminal liability in the Member States of the manufacturer and, where applicable, of the person responsible for placing the plant protection product on the market or using it should remain applicable.
V državah članicah bi morala še naprej veljati splošna civilna in kazenska odgovornost proizvajalca in, kjer je to primerno, osebe, odgovorne za dajanje fitofarmacevtskega sredstva v promet ali za uporabo tega sredstva.