natgillin/translations-raw huggingface dataset:
Z odstopanjem od člena 5 se aktivna snov, ki izpolnjuje merila iz člena 4, odobri za največ 15 let, kadar se lahko pričakuje, da bo fitofarmacevtsko sredstvo, ki to snov vsebuje, povzročilo le majhno tveganje za zdravje ljudi in živali ter za okolje.
By way of derogation from Article 5, an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years, where it may be expected that plant protection products containing that substance will pose only a low risk to human and animal health and the environment.
Odstopanje se ne uporablja za aktivne snovi, razvrščene v skladu z Direktivo št. 67/548/ES kot:
The present derogation shall not apply to any active substance classified in accordance with Directive 67/548/EEC as:
ali snovi, ki so razvrščene kot:
or to substances that are qualified as:
– bioakumulativne in težko razgradljive.
– bioaccumulative and non-readily degradable.
Komisija do ...* pregleda in po potrebi določi merila za obravnavo aktivnih snovi kot snovi z majhnim tveganjem ter predloži predloge, če je to primerno.
No later than ...*, the Commission shall review and if necessary specify the criteria for treating an active substance as a low risk substance and, if appropriate, submit proposals.
Določiti je treba jasna in objektivna merila za opredelitev snovi, ki se lahko označijo kot snovi z nizkim profilom tveganja.
There is a need to lay down clear and objective criteria to define which substances can claim to have a low risk profile.
Zaradi spodbujanja raziskav manj škodljivih snovi in izdelkov, je treba zagotoviti, da si bodo podjetja na jasnem in bo obstajala pravno gotovost glede tega, kaj točno pomenijo aktivne snovi z majhnim tveganjem.
To encourage research for less harmful substances and products, it is important to provide businesses with clarity and legal certainty on what exactly is meant by a low risk profile.
Po teh merilih se 25 do 30 odstotkov aktivnih snovi obravnava kot aktivne snovi z majhnim tveganjem.
With these criteria 25 to 30 percent of active substances would be considered as low risk.
Z odstopanjem od člena 5 in člena 14(2) se aktivna snov, ki izpolnjuje merila iz člena 4, odobri za največ sedem let, če so ostale že odobrene aktivne snovi veliko manj strupene za potrošnike ali delavce ali predstavljajo veliko manjše tveganje za okolje.
By way of derogation from Article 5 and Article 14(2), an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding seven years, where other already approved active substances are significantly less toxic for consumers or operators or present significantly fewer risks for the environment.
Pri ocenjevanju se upoštevajo merila iz točke 4 Priloge II.
The assessment shall take account of the criteria laid down in point 4 of Annex II .
Aktivna snov, ki izpolnjuje merila iz člena in merila iz točke 4 in merila iz točke 4 priloge II , se razvrsti in odobri kot „snov , ki jo treba nadomestiti “.
An active substance complying with the criteria provided for in Article 4 and the criteria provided for in point 4 of Annex II shall be classified and approved as a ‘candidate for substitution’.
Takšna snov je v nadaljnjem besedilu „ možna nadomestna snov“.
Such a substance is referred to hereinafter as a ‘candidate for substitution’ .
Odobritev velja za obdobje desetih let.
The approval shall be valid for a period of 10 years.
Člen 14(2) se ne uporablja.
Article 14(2) shall not apply.
Pri razvrstitvi aktivnih snovi kot „snovi, ki jih je treba nadomestiti” je pomembno, da so izpolnjena merila, določena v predlogu uredbe.
To be classified as candidates for substitution, active substances have to conform to the criteria laid down in the draft regulation.
V vseh državah članicah se uporabljajo enotni obrazci za zahtevke.
Application forms shall be standard in all Member States.
To je odvisno od časa, ki ga vlagatelj potrebuje, da priskrbi dodatne informacije.
This shall be based on the time that the applicant needs to provide the additional information.
Vlagatelji morajo imeti dovolj časa, da priskrbijo dodatne informacije.
Applicants must receive adequate time to supply extra information.
Država članica, ki ji je predložen zahtevek v skladu s členom 39, odobri zadevno fitofarmacevtsko sredstvo pod enakimi pogoji, vključno z razvrstitvijo za namene Direktive 1999/45/ES, kot referenčna država članica .
The Member State to which an application under Article 39 is submitted shall authorise the plant protection product concerned under the same conditions, including classification for the purpose of Directive 1999/45/EC, as the reference Member State.
Država članica, ki ji je predložen zahtevek v skladu s členom 39, odobri zadevno fitofarmacevtsko sredstvo pod enakimi pogoji, vključno z razvrstitvijo za namene Direktive 1999/45/ES, kot referenčna država članica , razen če prva država članica lahko dokaže, da ima uporaba fitofarmacevtskega sredstva na njenem ozemlju drugačen vpliv na okolje kot v referenčni državi članici.
The Member State to which an application under Article 39 is submitted shall authorise the plant protection product concerned under the same conditions, including classification for the purpose of Directive 1999/45/EC, as the reference Member State , unless the Member State can show that the use of a plant protection product has a different effect on the environment on its territory in comparison with the reference Member State .
Države članice bi morale imeti zadnjo besedo pri registraciji fitofarmacevtskih sredstev, saj se naravne razmere (prst, voda in podnebje) lahko razlikujejo celo med državami članicami v istem območju.
Member States should have the final word on authorising plant protection products, since natural conditions (soil, water and climate) may vary considerably between Member States even within a given zone.
Vzajemno priznavanje se lahko zavrne le iz okoljevarstvenih razlogov.
But mutual recognition may be refused only on environmental grounds.
Ne glede na določbe člena 29 se fitofarmacevtsko sredstvo registrira kot sredstvo z manjšim tveganjem, če so izpolnjene naslednje zahteve:
Notwithstanding Article 29, a plant protection product shall be authorised as a reduced risk product if it satisfies the following requirements:
(c) glede na znanstvene ali tehnične podatke manj ogrožajo zdravje ljudi in živali ali okolje kot primerljivo fitofarmacevtsko sredstvo, ki je že registrirano;
(c) it entails, in the light of scientific or technical knowledge, considerably fewer risks to human and animal health or the environment than a comparable plant protection product that is already authorised;
(e) je v skladu s členom 29(1)(b), (c) in (e) do vključno (h).
(e) it complies with Article 29(1)(b), (c) and (e) to (h) inclusive.
Vlagatelji zahtevka za registracijo fitofarmacevtskega sredstva z manjšim tveganjem morajo dokazati, da sredstvo izpolnjuje pogoje iz odstavka 1, in zahtevku priložiti podrobno in strnjeno dokumentacijo za vsako točko zahtevanih podatkov o aktivni snovi in fitofarmacevtskem sredstvu.
Applicants for authorisation of a reduced risk plant protection product must demonstrate that it meets the conditions in paragraph 1 and enclose with the application a detailed and a summary dossier for each point of the details required for the active substance and the plant protection product.
Država članica v 120 dneh sprejme odločitev o odobritvi zahtevka za registracijo fitofarmacevtskega sredstva z manjšim tveganjem.
The Member State shall decide within 120 days whether to approve an application for authorisation for a reduced risk plant protection product.
Če država članica zahteva dodatne informacije, določi rok, v katerem mora vlagatelj te informacije predložiti.
If the Member State requires additional information, it shall set a deadline by which the applicant must provide the information.
V tem primeru se obdobje 120 dni podaljša za dodatno obdobje, ki ga je ta država članica odobrila.
In such a case the period of 120 days shall be extended by the additional period that the Member State has granted.
Vse potrebne raziskave za določitev najvišjih dovoljenih ravni za ostanke lahko izvajajo znanstvene ustanove ali uradni organi.
The studies necessary in order to determine maximum residue levels may be carried out by scientific institutes or official bodies.
Stroški znanstvenih raziskav močno ovirajo razvoj uporabe v manjši meri.
The cost of scientific studies poses a very serious obstacle to the development of minor uses.
Ta sprememba želi ponuditi ekonomsko lažje izvedljive rešitve.
The amendment is intended to offer more viable solutions from the economic point of view.
Merila, ki veljajo za registracijo uporabe v manjši meri, vključujejo ekstrapolacijo podatkov, pridobljenih pri drugih botanično in kmetijsko zelo podobnih kulturah.
The criteria for authorisation for minor uses shall allow for extrapolation of data obtained for other botanically and agronomically closely similar crops.
Pri kulturah z znatnimi podobnostmi, kot na primer obstajajo med češnjami in ciborami, bi bilo treba podatke za prvo registracijo ekstrapolirati, da se olajša razširitev na uporabo v manjši meri.
When crops are as closely similar as, for example, the cherry and the sloe, the data obtained for the first authorisation should be extrapolated to enable minor uses to be authorised as well.
Člen 49, odstavek 6 a (novo)
Article 49, paragraph 6 a (new)
Komisija Evropskemu parlamentu in Svetu najkasneje do ...* predloži predlog za ustanovitev evropskega spodbujevalnega sklada za uporabo v manjši meri.
The Commission shall, not later than ...*, present a proposal to the European Parliament and the Council for establishing a European promotion fund for minor uses.
Sklad bi se lahko financiral iz prihodkov od davkov na sredstva za varstvo pred škodljivci.
The fund may be financed from the income from taxes on pest control products.
Iz sklada bo mogoče financirati tudi dodatne preiskave na vsebnost ostankov pri uporabi v manjši meri.
The Fund shall also be entitled to finance additional residue tests for minor uses.
Pomembno je, da je za omejeno uporabo na voljo dovolj fitofarmacevtskih sredstev.
It is important that sufficient plant protection products remain available for restricted application.
Pri tem bi lahko imel evropski spodbujevalni sklad pomembno vlogo.
A European Promotion Fund could play an important role here.
Člen 49 a (novo)
Article 49 a (new)
Z odstopanjem od člena 28(1) države članice dovolijo, da se fitofarmacevtska sredstva prek vzporedne trgovine uvažajo in dajejo v promet na njihovem območju šele po opravljenem upravnem postopku, v katerem se preveri, ali je sredstvo istovetno že registriranemu fitofarmacevtskemu sredstvu ("referenčnemu fitofarmacevtskemu sredstvu").
By way of derogation from Article 28(1), Member States shall allow the import and placing on the market of a plant protection product within their territory through parallel trade only after an administrative procedure to verify that it is identical to the plant protection product which is already authorised ('reference plant protection product').
Če je temu tako, pristojni organ imenovane države članice izda za uvoženo fitofarmacevtsko sredstvo potrdilo o istovetnosti.
Where this is the case, the imported plant protection product shall receive an identity certificate from the competent authority of the designated Member State .
Uvozniki fitofarmacevtskega sredstva pred prvim uvozom in dajanjem na trg zaprosijo pristojni organ imenovane države članice za izdajo potrdila o istovetnosti fitofarmacevtskega sredstva, ki ga želijo uvoziti.
The importers of a plant protection product shall apply for an identity certificate from the competent authority of the designated Member State for the plant protection product they want to import before the first import and the first placing on the market.
Pristojni organ imenovane države članice v 45 dneh odloči, ali so zahteve iz tega člena izpolnjene.
The competent authority of the designated Member State shall decide within 45 days if the requirements under this article are fulfilled.
Če ugotovi, da je temu tako, prejme uvoznik za zadevno sredstvo potrdilo o istovetnosti.
If the authority ascertains that those requirements are fulfilled, the importer shall receive an identity certificate for the product in question.
Vlagatelju ni treba predložiti poročil o informacijah, poskusih in študijah, ki se zahtevajo za registracijo fitofarmacevtskega sredstva.
The applicant shall be exempted from supplying the information, test and study reports required for an authorisation of a plant protection product.
Pristojni organ, ki sprejme vlogo, zaprosi pristojni organ države izvora, da:
The competent authority receiving the application shall ask the competent authority of the country of origin:
(a) ugotovi natančno sestavo sredstva, preveri, ali je ta enaka kot pri fitofarmacevtskem sredstvu, ki je registrirano v referenčni državi članici ter
(a) to establish the exact composition of the product to check that it is identical to a plant protection product authorised in the reference Member State, and
(b) preveri, ali je bilo sredstvo v tej državi članici registrirano v skladu s postopkom registracije iz te uredbe ali Direktive 91/414/EGS.
(b) to check that the product is authorised in that Member State in accordance with the authorisation procedure laid down in Directive 91/414/EEC or in this Regulation.
Vzporedno uvoženih sredstev se ne sme prepakirati.
Products subject to parallel imports may not be repackaged.
Potrdilo o istovetnosti poteče z registracijo referenčnega sredstva ali potekom registracije uvoženega sredstva v državi, od koder je bilo izvoženo.
The identity certificate shall expire with the authorisation of the reference product or the expiry of the authorisation of the imported product in the Member State from which it is exported.
Če se registracija referenčnega proizvoda prekliče iz razlogov, ki niso povezani z zdravjem ali okoljem, lahko uvoznik uvoženo sredstvo prodaja naprej še eno leto od datuma preklica.
If the authorisation of the reference product is withdrawn for reasons other than health or environmental reasons, the importer may continue to sell the imported product for one year after the date of withdrawal.
Študija , ki se predloži za podaljšanje ali pregled registracije ni zaščitena, razen če je potrebna za namene spreminjanja zakonodaje .
A study submitted for the renewal or review of an authorisation shall not be protected except where required for the purposes of amending the legislation .
Predlog Komisije pomeni velik napredek glede na sedanje stanje in perspektivnost malih in srednje velikih evropskih podjetij.
The Commission proposal constitutes a giant step forward from the present situation from the point of view of protecting the viability of small and medium-sized European enterprises.
Namen predlagane spremembe je pojasniti bistvo besedila.
The amendment is intended to clarify the substance of the text.
Da bi spodbudili razvijanje (novo pridobljenih) fitofarmacevtskih sredstev za manj razširjene posevke, je pomembno, da se podaljša obdobje varstva podatkov in s tem donos iz naložbe.
To encourage the development of (derived) plant protection products specifically for minor crops, it is important to extend the data protection, and thus the return on the investment.
Člen 56, odstavek 2, točka (b a) (novo)
Article 56, paragraph 2, point (b a) (new)
(ba) če pride do nastanka monopola.
(ba) where a monopoly is created.
Nova uredba bi morala vsebovati posebne določbe, ki bi preprečevale nastajanje monopolov na trgu fitofarmacevtskih sredstev.
The new regulation should lay down special provisions to prevent monopolies being created on the market in plant protection products.
Morebitni vlagatelj registracije in imetnik ali imetniki zadevnih registracij sprejmejo vse ustrezne ukrepe za dosego dogovora o izmenjavi poročil o poskusih in študijah, varovanih v skladu s členom 56, ki jih zahteva vlagatelj za registracijo fitofarmacevtskega sredstva.
The prospective applicant for the authorisation and the holder or holders of relevant authorisations shall take all reasonable steps to reach agreement on the sharing of any test and study reports protected under Article 56 that are required by the applicant for authorisation of a plant protection product.
Da se zagotovi pravičen, pregleden in nediskriminacijski obračun stroškov izmenjave informacij, lahko Komisija v skladu s postopkom iz člena 76(3) sprejme na osnovi teh načel smernice o delitvi stroškov.
In an endeavour to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way, the Commission may, in accordance with the procedure referred to in Article 76(3), adopt cost-sharing guidelines based on those principles.
Komisija najkasneje …* pregleda določbe te uredbe o varstvu podatkov za poskuse in študije, ki vključujejo vretenčarje.
By ...* the Commission shall carry out a review of the provisions in this Regulation concerning data protection for tests and studies involving vertebrate animals.
* v sedmih letih po začetku veljavnosti te uredbe
* Seven years after the entry into force of this Regulation.
Po tem predlogu so rezultati poskusov na vretenčarjih zaščiteni, vendar si jih je treba izmenjevati.
Under this proposal the results from tests involving vertebrate animals enjoy data protection, but such data have to be shared.
Kompromis je v tem trenutku potreben iz praktičnih razlogov (drugače mnogih novih proizvodov ne bo mogoče tržiti), vendar ga je treba v doglednem času oceniti.
This compromise is at present necessary for practical reasons (otherwise many new products will not be marketable), but should be evaluated in due course.
Pristojni organ predlagatelju omogoči, da poda svoje mnenje, nato pa sprejme odločitev o zaupnosti podatkov, ki jo primerno utemelji.
After giving the claimant an opportunity to state his views, the competent authority shall adopt a decision on the confidentiality of the information, which shall contain an adequate statement of the reasons on which it is based.
O tem obvesti predlagatelja.
It shall communicate the decision to the claimant.
Člen 60, odstavek 2, točki (c a) (novo) in (c b) (novo)
Article 60, paragraph 2, point (c a) (new) and (c b) (new)
(ca) imena in osebni podatki znanstvenikov in laborantov, pristojnih za izvajanje poskusov in študij, pri katerih se uporabljajo vretenčarji;
(ca) the names and personal details of scientists and laboratory assistants responsible for carrying out tests and studies in which use is made of vertebrate animals;
(cb) informacije o tekočih poskusih ali testih v raziskovalne ali razvojne namene, kot je določeno v členu 51.
(cb) information on current experiments or tests for research or development purposes, as defined in Article 51.
Zaupnost informacij, ki ščiti poslovne interese, je treba oceniti za vsak primer posebej glede na utemeljitve posameznega predlagatelja.
The confidentiality of information to protect commercial interests must be considered on a case-by-case basis in the light of the arguments put forward by the applicant concerned.
V vsakem primeru so informacije o raziskavah in razvoju pogosto zelo občutljive in jih je treba praviloma obravnavati zaupno.
In any event, information on research and development is often highly sensitive and should therefore as a rule be treated in confidence.
Laboranti, ki izvajajo poskuse na živalih, so pogosto tarča napadov, zato je treba njihove osebne podatke varovati.
Laboratory assistants who carry out animal testing are often the target of attacks and their details must therefore be protected.
MNENJE Odbora za notranji trg in varstvo potrošnikov (*)
OPINION of the Committee on the Internal Market and Consumer Protection (*)
Predlagana uredba naj bi nadomestila Direktivo 91/414/EGS o dajanju fitofarmacevtskih sredstev v promet in razveljavila Direktivo Sveta 79/117/EGS o prepovedi prometa in uporabe fitofarmacevtskih sredstev, ki vsebujejo nekatere aktivne snovi.
This proposed regulation is intended to replace Directive 91/414/EEC concerning the placing of plant protection products on the market and to repeal Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances.
Uporaba fitofarmacevtskih sredstev ima učinek na kmetijske ekosisteme, lahko je nevarna za zdravje uporabnikov, poslabšuje kakovost živil in negativno vpliva na zdravje potrošnikov, če se v živilih nahajajo škodljivi ostanki fitofarmacevtskih sredstev.
The use of plant protection products has an impact on agricultural eco-systems and can pose a health threat for users, impair the quality of food and have an adverse effect on consumer health if harmful residues of these products are found in food.
Po drugi strani se fitofarmacevtska sredstva uporabljajo za zaščito in v interesu zdravja poljščin ter kmetom omogočajo podvojitev pridelka in večjo fleksibilnost pri pridelavi kultur.
On the other hand, plant production products are used to protect and promote the health of crops and allow farmers to double their yield and plant crops more flexibly.
To zagotavlja zanesljivo in lokalno pridobivanje cenovno ugodnih kmetijskih proizvodov, zmanjšuje potrebo po površinah za proizvodnjo živil in evropskim državam omogoča večjo neodvisnost od uvoza kmetijskih proizvodov.
This ensures that agricultural produce can be produced locally, cheaply and reliably, reduces the area of land needed for food production and gives European countries a high degree of independence from agricultural imports.
Eden od ključnih namenov predloga je bolje uskladiti odobritve fitofarmacevtskih sredstev v EU in s tem dodatno okrepiti notranji trg.
A key concern of the proposal is to increase the harmonisation of the approval of plant protection products throughout the EU, thereby further strengthening the internal market.
Pripravljavka mnenja podpira pristop, s katerim bi se poleg rednega postopka odobritve v državah članicah uvedel še postopek obveznega vzajemnega priznavanja odobritev v državah članicah z istega območja, saj bo s tem preprečeno nepotrebno podvajanje dela v državah članicah, kar bo posledično privedlo do hitrejše dostopnosti inovativnih in okolju prijaznih fitofarmacevtskih sredstev.
Your draftswoman supports the approach of introducing a procedure for obligatory zonal mutual recognition of approvals in Member States, in addition to the regular approval procedure, since this will avoid unnecessary duplication of effort in the Member States and ultimately lead to innovative and more environmentally-friendly plant protection products becoming more rapidly available.
Poleg tega predlaga, da bi moralo biti pod določenimi pogoji možno vzajemno priznavanje odobritev med območji.
Furthermore, she proposes that under certain conditions interzonal mutual recognition of approvals, should also be possible.
Po drugi strani je treba zagotoviti, da se bodo lahko pri odobritvi v posameznih primerih upoštevale razlike v kmetijstvu in podnebju med državami članicami nekega območja.
On the other hand, measures must be taken to ensure that agricultural and climatic differences between the Member States in a given zone are taken into account in issuing individual approvals.
Na področju varstva podatkov študij, ki jih je treba predložiti za odobritev fitofarmacevtskih sredstev, poročevalka predlaga ureditev, ki bo zagotovila konkurenčnost evropskega gospodarstva in inovativnost pridelovalcev rastlin, ki se ukvarjajo z raziskavami, ter hkrati proizvajalcem generičnih proizvodov omogočala dostop do trga.
As regards data protection in respect of studies which must be submitted for the approval of plant protection products, your draftswoman proposes arrangements which will ensure the competitiveness of Europe’s economy and the innovative capacity of plant producers engaged in research, while at the same time allowing the producers of generic products to access the market.