natgillin/translations-raw huggingface dataset:
Pri tem se še posebej upoštevajo posebnosti pri odobritvi fitofarmacevtskih sredstev in v njih vsebovanih aktivnih snovi, zlasti avtomatično prenehanje veljavnosti prvih odobritev po desetih letih.
In this context, particular attention is paid to special conditions relating to the approval of plant protection products and the active substances they contain, in particular the automatic expiry of first approvals after ten years.
Pripravljavka mnenja meni, da je na področju vzporednega uvoza fitofarmacevtskih sredstev potrebna pravna ureditev na ravni EU.
Your draftswoman considers that legal provisions at EU level on parallel imports of plant protection measures are necessary.
Trenutno obstaja velika pravna negotovost zaradi nasprotujočih si sodb sodišč in velikih razlik med državami članicami pri ravnanju z uvoznimi artikli.
There is great legal uncertainty at present due to conflicting court judgments and major differences in the ways in which Member States address imports.
ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti, zlasti člena 37(2) in člena 152(4)(b) Pogodbe,
Having regard to the Treaty establishing the European Community, and in particular Articles 37(2) and 152(4)(b) thereof,
ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti, zlasti člena 37(2) , člena 152(4)(b) in člena 95(1) Pogodbe,
Having regard to the Treaty establishing the European Community, and in particular Articles 37(2) , 152(4)(b) and 95(1) thereof,
Cilj uredbe je zagotoviti prost pretok blaga na področju fitofarmacevtskih sredstev na skupnem notranjem trgu s pomočjo usklajenih pravil o dajanju tovrstnih proizvodov v promet (glej uvodno izjavo (7) in poglavje III).
The purpose of the Regulation is to ensure the free movement of goods in the field of plant protection products in the common internal market by means of harmonised rules on the placing of such products on the market (see Recital (7) and Chapter III).
Zaradi tega bi morala uredba temeljiti tudi na členu 95(1) Pogodbe o ES kot pravni podlagi.
For this reason the Regulation should also have Article 95(1) TEC as its legal basis.
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.
Namen te uredbe je tudi uskladitev pravil o dajanju fitofarmacevtskih izdelkov v promet, da bi prišlo do uskladitve razpoložljivosti fitofarmacevtskih sredstev med kmeti v različnih državah članicah.
The purpose of this regulation is furthermore to harmonise the rules on the placing on the market of plant protection products in order to harmonise the availability of plant protection products between farmers in different Member States.
(18) „dobra praksa varstva rastlin“
(18) ‘Good Plant Protection Practice’
je praksa, pri kateri se izbere, odmeri in časovno uvrsti obdelava zadevnega posevka s fitofarmacevtskimi sredstvi, v skladu s pogoji njihove registrirane uporabe za zagotovitev optimalne učinkovitosti s čim manjšo količino, ki je potrebna, ob upoštevanju lokalnih razmer ter možnosti zatiranja s pomočjo ustreznih metod pridelave in bioloških sredstev;
Practice whereby the treatments with plant protection products applied to a given crop, in conformity with the conditions of their authorised uses, are selected, dosed and timed to ensure optimum efficacy with the minimum quantity necessary, taking due account of local conditions and of the possibilities for cultural and biological control;
je praksa, pri kateri se izbere, odmeri in časovno uvrsti obdelava zadevnega posevka s fitofarmacevtskimi sredstvi, v skladu s pogoji njihove registrirane uporabe za zagotovitev optimalne učinkovitosti s čim manjšo količino, ki je potrebna, ob upoštevanju lokalnih razmer , potrebe po preprečevanju nastanka odpornosti ter možnosti zatiranja s pomočjo ustreznih metod pridelave in bioloških sredstev;
Practice whereby the treatments with plant protection products applied to a given crop, in conformity with the conditions of their authorised uses, are selected, dosed and timed to ensure optimum efficacy with the minimum quantity necessary, taking due account of local conditions , of the need to prevent the build-up of resistance and of the possibilities for cultural and biological control.
Preprečitev nastanka odpornosti je zato treba vključiti v opredelitev dobre prakse varstva rastlin.
Prevention of the build-up of resistance therefore needs to be included in the definition of good plant protection practice..
Člen 3, točka 19
Article 3, point 19
(19) „dobra okoljska praksa“
(19) ‘Good Environmental Practice’
je praksa pri varstvu rastlin, ki vključuje uporabo fitofarmacevtskih sredstev in ravnanje z njimi na način, ki najmanj onesnažuje okolje;
Practice in plant protection which includes the handling and application of plant protection products in a way which only contaminates the environment with the smallest amount practicable;
Ta nova opredelitev je odvečna in bi v praksi privedla do trenj in težav z interpretacijo, saj zahteva, da je treba s fitofarmacevtskimi sredstvi ravnati "na način, ki najmanj onesnažuje okolje", že sodi med glavna načela dobre prakse varstva rastlin.
This new definition is superfluous and would in practice lead to friction and problems of interpretation, since the requirement to use plant protection products in a way ‘which only contaminates the environment with the smallest amount practicable’ is already one of the main principles of good plant protection practice.
Poleg tega nova opredelitev ni dovolj jasna.
Moreover, the new definition is too vague.
Člen 3, točka 22 (novo)
Article 3, point 22 (new)
(22) „dobra preskusna praksa“
(22) ‘Good Experimental Practice’
je praksa, kot jo opredeljuje Direktiva 2004/10/ES o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri preskusih kemičnih snovi 1 ;
Practice as defined by Directive 2004/10/EC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances; 1
1 UL L 50, 20.2.2004, str.
1 OJ L 50, 20.2.2004, p.
Člen 3, točka 23 (novo)
Article 3, point 23 (new)
(23) „Preskusi in študije“
(23) ‘Tests and studies’
je raziskovanje ali preskus, katerega namen je določiti lastnosti in obnašanje aktivne snovi ali fitofarmacevtskih sredstev, napovedati izpostavljenost aktivnim snovem in/ali njihovim ustreznim metabolitom, določiti varne ravni izpostavljenosti in vzpostaviti pogoje za varno uporabo fitofarmacevtskih sredstev;
Investigation or experiment whose purpose is to determine the properties and behaviour of an active substance or of plant protection products, predict exposure to active substances and/or their relevant metabolities, determine safe levels of exposure and establish conditions for the safe use of plant protection products;
Terminologija poročil o preskusih in študijah se v tej uredbi večkrat uporablja.
Test and study reports terminology is used repeatedly throughout this regulation.
Člen 3, točka 24 (novo)
Article 3, point 24 (new)
(24) „dobra kmetijska praksa“
(24) ‘Good Agricultural Practice’
pri uporabi fitofarmacevtskih sredstev vključuje varne načine uporabe fitofarmacevtskih sredstev, odobrene na nacionalni ravni, pod dejanskimi pogoji, potrebnimi za učinkovito varstvo pred škodljivci.
Good Agricultural Practice in the use of plant protection products (GAP) includes the nationally authorised safe uses of plant protection products under actual conditions necessary for effective pest control.
Obsega vrsto ravni uporabe fitofarmacevtskih sredstev, vse do najvišje dovoljene uporabe, ki poteka na način, pri katerem nastaja najmanjša možna količina ostankov.
It encompasses a range of levels of plant protection product applications up to the highest authorised use, applied in a manner which leaves the smallest practicable amount of residue .
Odobreni načini varne uporabe so določeni na nacionalni ravni in vključujejo nacionalno registrirane ali priporočene načine uporabe, ki upoštevajo vidike javnega zdravja in zdravja pri delu ter varstva okolja.
Authorised safe uses are determined at the national level and include nationally registered or recommended uses, which take into account public and occupational health and environmental safety considerations.
Dejanski pogoji obsegajo vse stopnje proizvodnje, skladiščenja, prevoza in distribucije živil in krmil.
Actual conditions include any stage in the production, storage, transport, distribution of food commodities and animal feed.
V uredbo bi bilo treba vključiti opredelitev "dobre kmetijske prakse" Organizacije ZN za prehrano in kmetijstvo.
The Food and Agriculture Organisation’s definition of ‘good agricultural practice’ should be incorporated into the Regulation.
Člen 3, točka 25 (novo)
Article 3, point 25 (new)
(25) „uporabe v manjši meri“
(25) ‘Minor uses’
za namene te uredbe pomeni uporaba fitofarmacevtskega sredstva v manjši meri v določeni državi uporabo tega sredstva na posevku, ki v tej državi članici ni splošno razširjen, ali na splošno razširjenem posevku, za zadovoljitev omejenih ali občasnih in izjemnih potreb, ali na semenu.
For the purpose of this Regulation, minor use of a plant protection product in a particular Member State means the use of that product on a crop which is not widely grown in that Member State or on a widely grown crop in order to meet a limited or sporadic and exceptional need or on seed.
(a) nimajo škodljivih vplivov na zdravje ljudi, vključno z ranljivimi skupinami , ali zdravje živali, ob upoštevanju ugotovljenih kumulativnih in sinergijskih učinkov, kadar obstajajo metode za ocenjevanje takšnih učinkov, ali vplivov na podzemno vodo;
(a) they shall not have any harmful effects on human health , including vulnerable groups, or animal health, taking into account known cumulative and synergistic effects when the methods to assess such effects are available, or on ground water;
(a) nimajo škodljivih vplivov na zdravje ljudi, zlasti zdravje ranljivih skupin, kot so nosečnice, še nerojeni otroci, dojenčki in otroci , ali zdravje živali, ob upoštevanju ugotovljenih kumulativnih in sinergijskih učinkov, kadar obstajajo metode za ocenjevanje takšnih učinkov, ali vplivov na podzemno vodo;
(a) they shall not have any harmful effects on human health, in particular that of vulnerable groups such as pregnant women, the unborn, infants and children , or animal health, taking into account known cumulative and synergistic effects when the methods to assess such effects are available, or on ground water;
Dostop do povzetka dokumentacije
Access to the summary dossier
Agencija povzetek dokumentacije iz člena 8(1) brez odlašanja da na voljo javnosti, razen zaupnih podatkov v skladu s členom 60.
The Authority shall without delay make the summary dossier referred to in Article 8(1) available to the public, excluding any information which is confidential under Article 60.
Ker so te informacije tej začetni fazi prehodnega značaja, niso primerne za razkritje v javnosti.
The preliminary nature of this information at this early stage does not make it suitable for public disclosure.
Primerneje bi bilo razkritje poročila o pregledu organov, saj je bilo uradno potrjeno.
Disclosing the authorities review report is more appropriate since it has been officially validated.
Država članica poročevalka lahko začne z ocenjevanjem poročil o preskusih in študijah, takoj ko jih prejme od vlagatelja, tudi že pred datumom uradnega obvestila iz prvega pododstavka člena 9(3).
The rapporteur Member State may start the evaluation of test and study reports as soon as they are submitted by the applicant, including before the date of notification provided for in the first subparagraph of Article 9(3).
V osmih mesecih po datumu uradnega obvestila iz prvega pododstavka člena 9(3) država članica poročevalka pripravi in Agenciji predloži poročilo (v nadaljnjem besedilu „osnutek poročila o oceni“), v katerem oceni, ali je verjetno, da bo aktivna snov izpolnila zahteve iz člena 4.
Within eight months of the date of the notification provided for in the first subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit to the Authority a report (hereafter called “draft assessment report”) assessing whether the active substance can be expected to meet the requirements of Article 4.
Država članica se lahko posvetuje z Agencijo.
It shall inform the Commission and the Authority.
V tem primeru se obdobje osmih mesecev podaljša za dodatno časovno obdobje, ki ga odobri država članica.
In that case, the eight-month period shall be extended by the additional time period granted by the Member State.
Pri predložitvi dodatnih informacij vlagatelj hkrati predloži vse zahtevke za varstvo podatkov v skladu s členom 56.
When supplying additional information, the applicant shall at the same time submit any claims for data protection pursuant to Article 56.
Člen 11, odstavek 1a (novo)
Article 11, paragraph 1a (new)
Država članica poročevalka predloži Komisiji in agenciji tudi poročilo, v katerem navede vse načine uporabe, ki so bili ocenjeni in so v skladu z zahtevami iz člena 29 primerni za registracijo.
The rapporteur Member State shall also provide the Commission and the Authority with a report setting out all the uses that have been evaluated and that are acceptable for authorisation, in line with the requirements of Article 29.
Snovi bi bilo treba odobriti že ob ugotovitvi prvih varnih načinov uporabe.
A substance should be approved as early as the first safe uses have been identified.
Tako bodo kmetom prej na voljo novi in inovativni proizvodi.
This will make new, innovate products available to farmers earlier.
Člen 12, odstavki 1 do 3
Article 12, paragraphs 1 to 3
Agencija osnutek poročila o oceni, ki ga je prejela od države članice poročevalke, posreduje vlagatelju, drugim državam članicam in Komisiji.
The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant, the other Member States and the Commission.
Agencija poročilo da na voljo javnosti, vendar pa vlagatelju omogoči rok dveh tednov, v katerih lahko v skladu s členom 60 zahteva, da nekateri deli osnutka poročila o oceni ostanejo zaupni.
It shall make it available to the public, after giving the applicant two weeks to request, pursuant to Article 60, that certain parts of the draft assessment report be kept confidential.
Agencija po potrebi organizira posvetovanje s strokovnjaki, vključno s strokovnjaki iz države članice poročevalke.
Where appropriate, the Authority shall organise a consultation of experts, including experts from the rapporteur Member State.
Agencija sprejme sklep o tem, ali se pričakuje, da bo aktivna snov izpolnila pogoje iz člena 4 v šestdesetih dneh od konca obdobja iz odstavka 1 tega člena, ter o tem obvesti vlagatelja, države članice in Komisijo.
The Authority shall adopt a conclusion on whether the active substance can be expected to meet the requirements of Article 4 within sixty days of the end of the period provided for in paragraph 1 of this Article and communicate it to the applicant, the Member States and the Commission.
Agencija po potrebi v sklepih obravnava možnosti za zmanjševanje tveganja, določene v osnutku poročila o oceni.
Where appropriate, the Authority shall address in its conclusion the risk mitigation options identified in the draft assessment report.
V tem primeru se obdobje šestdesetih dni iz odstavka 2 podaljša za dodatno obdobje, ki ga odobri Agencija.
In that case, the sixty-day period provided for in paragraph 2 shall be extended by the additional period granted by the Authority.
Agencija lahko od Komisije zahteva, da se posvetuje z referenčnim laboratorijem Skupnosti, ustanovljenim v skladu z Uredbo (ES) št. 882/2004, zaradi preverjanja, ali je analizna metoda za določitev ostankov, ki jo predlaga vlagatelj, ustrezna in izpolnjuje zahteve iz člena 29(1)(f) te uredbe.
The Authority may ask the Commission to consult a Community reference laboratory, designated pursuant to Regulation (EC) No 882/2004 for the purposes of verifying whether the analytical method for the determination of the residues proposed by the applicant is satisfactory and meets the requirements of Article 29(1)(f) of this Regulation.
Vlagatelj na zahtevo referenčnega laboratorija Skupnosti predloži vzorce in analizne standarde.
The applicant shall, if requested by the Community reference laboratory, provide samples and analytical standards.
V šestih mesecih po prejemu sklepa Agencije iz člena 12(2) Komisija Odboru iz člena 76(1) predloži poročilo (v nadaljnjem besedilu „poročilo o pregledu“) ob upoštevanju osnutka poročila o oceni, ki ga oblikuje država članica poročevalka v skladu s členom 11, in sklepa Agencije v skladu s členom 12.
Within six months of receiving the conclusion provided for in Article 12(2) from the Authority, the Commission shall present a report, ( herinafter referred to as “the review report”, to the Committee referred to in Article 76(1), taking into account the draft assessment report by the Rapporteur Member State under Article 11 and the conclusion of the Authority under Article 12.
V štirih mesecih po prejemu sklepa Agencije iz člena 12(2) Komisija Odboru iz člena 76(1) predloži poročilo (v nadaljnjem besedilu „poročilo o pregledu“) ob upoštevanju osnutka poročila o oceni, ki ga oblikuje država članica poročevalka v skladu s členom 11, in sklepa Agencije v skladu s členom 12.
Within four months of receiving the conclusion provided for in Article 12(2) from the Authority, the Commission shall present a report, ( hereinafter referred to as “the review report”), to the Committee referred to in Article 76(1), taking into account the draft assessment report by the Rapporteur Member State under Article 11 and the conclusion of the Authority under Article 12.
Vlagatelj ima možnost predložiti pripombe na poročilo o pregledu.
The applicant shall be given the opportunity to submit comments on the review report.
Komisija v treh mesecih po prejemu poročila, omenjenega v členu 11(1), predstavi predlog za omejeno registracijo aktivne snovi, v katerem določi:
Within three months of receiving the report mentioned in Article 11(1), the Commission shall present a proposal for the restricted authorisation of the active substance, setting out:
– načini uporabe, ki se jih sme registrirati,
– the uses that may be authorised,
– obdobje registracije, ki ne sme biti daljše od petih let.
– the time period for authorisation which may not exceed five years.
Pospešitev registracije načinov uporabe novih snovi bi morala kmetom omogočiti zgodnji dostop do novih in inovativnih proizvodov.
Speeding up the authorisation of uses for new substances should allow farmers an early access to new and innovative products.
Uporabljajo se člen 4(4) in členi 6 do 21.
Article 4(4) and Articles 6 to 21 shall apply .
Z odstopanjem od člena 5 se aktivne snovi, ki temeljijo na bioloških sredstvih in ki izpolnjujejo merila iz člena 4, odobri za največ 15 let, kadar se pričakuje, da bodo fitofarmacevtska sredstva, ki takšna biološka sredstva vsebuje, predstavljala le majhno tveganje za zdravje ljudi in živali ter za okolje, kot je določeno v členu 46(1).
Notwithstanding Article 5, active substances based on biological control agents which comply with the crite ria of Article 4 shall be given approval for a period not exceeding 15 years where plant protection products containing such biological control agents are expected to present only a low risk to human and animal health and the environment as defined in Article 46(1).
Uporabljajo se člen 4(4) in členi 6 do 21.
Article 4(4) and Articles 6 to 21 shall apply.
Pri ocenjevanju se upoštevajo merila iz točke 4 Priloge II.
The assessment shall take account of the crite ria laid down in point 4 of Annex II.
Aktivna snov, ki izpolnjuje kriterije, predvidene v členu 4, in enega ali več kriterijev iz točke 4 Priloge II se odobri kot "možno nadomestno snov".
An active substance complying with the criteria provided for in Article 4 and one or more crite ria in point 4 of Annex II shall be 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’.
Ker možne nadomestne snovi izpolnjujejo vse varnostne zahteve, podrobno opisane v členu 4, ni razloga za omejitev obdobja za njihovo odobritev na sedem namesto deset let.
Since substances candidate for substitution pass all safety requirements specified in Article 4, there are no reasons to limit its approval period to seven instead of ten years.
Kot pri drugih snoveh je mogoče odobritev v skladu s členom 21(1) kadar koli ponovno preučiti.
Like other substances, the approval can be reviewed at any time according to Article 21(1).
Ponovno preučevanje teh snovi tako ni potrebno oz. ne prinaša nobene vrednosti.
Therefore there is no need or value to review such substances every seven years .
Kadar se v fitofarmacevtskem sredstvu, registriranem po Direktivi 91/414/EGS 1 ali tej uredbi, uporabi pomožna snov v formulaciji, se šteje, da je bilo sredstvo v skladu s členom 15(1) Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta z dne 18. decembra 2006 o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) 1 , registrirano za posebno uporabo v fitofarmacevtskih sredstvih.
Where a co-formulant is used in a plant protection product that has been authorised under Directive 91/414/EEC or this Regulation it shall be regarded as being registered in accordance with Article 15(1) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 1 for the specific use in plant protection products .
Namen je izogniti se podvajanju predpisov za pomožne snovi v formulaciji, uporabljene v fitofarmacevtskih sredstvih, v tej uredbi in uredbi REACH.
Avoid double regulation of co-formulants used in plant protection products under this Regulation and REACH.
Z odstopanjem od člena 28(1) se lahko fitofarmacevtska sredstva v državah članicah dajejo v promet in uporabljajo, ne da bi bila tam registrirana, če ima tisti, ki želi dati fitofarmacevtsko sredstvo v promet, zanj potrdilo o tržljivosti, ki ga izda zadevna država članica.
Notwithstanding the provisions of Article 28(1), a plant protection product may be placed on the market and used in a Member State without being authorised there if the person wishing to market the plant protection product is in possession of a marketability certificate for the plant protection product issued by that Member State.
Države članice izdajajo na prošnjo potrdila o tržljivosti v smislu prvega odstavka za fitofarmacevtska sredstva, če je fitofarmacevtsko sredstvo, ki bo uvoženo iz druge države članice, v eni od držav članic že registrirano in je v državi uvoza registrirano snovno enako referenčno sredstvo (vzporedni uvoz).
Member States shall issue a marketability certificate within the meaning of paragraph 1 for a plant protection product upon request, providing the plant protection product to be imported from another Member State has already been authorised in another Member State and a reference product , which is compositionally equivalent is authorised in the importing state (parallel imports).
Snovna enakost v smislu tega člena obstaja, če uvoženo in referenčno sredstvo vsebujeta iste aktivne snovi v primerljivi količini z ustrezno najmanjšo stopnjo čistosti ter z določenimi nečistočami iste vrste in ustrezno najvišjo dovoljeno vsebnostjo ter se ujemata v načinu formulacije.
Compositional equivalence within the meaning of this Article shall be deemed to exist where imported and reference products contain the same active substances in comparable amounts with equivalent minimum purity levels and with certain impurities of the same type and equivalent maximum levels and have a matching formulation type.