natgillin/translations-raw huggingface dataset:
Brez poseganja v pravico držav članic, da sprejmejo začasne varnostne ukrepe, država članica, ki je izdala registracijo, oceni prejete informacije in obvesti druge države članice, kjer se odloči za preklic ali spremembo registracije v skladu s členom 44.
Without prejudice to the right of Member States to adopt interim protective measures, the Member State which granted an authorisation shall evaluate the information received and inform the other Member States, where it decides to withdraw or amend the authorisation under Article 44.
Ponovna vložitev predloga spremembe 189 s prve obravnave.
Reinstating first reading Amendment 189.
Člen 57 – odstavek 1 – uvod
Article 57 – paragraph 1 – introduction
Države članice dajejo javnosti na voljo v elektronski obliki informacije o fitofarmacevtskih sredstvih, registriranih ali preklicanih v skladu s to uredbo, ki vključujejo vsaj:
Member States shall keep information electronically available to the public on plant protection products authorised or withdrawn in accordance with this Regulation, containing at least:
Ponovna vložitev predloga spremembe 191 s prve obravnave.
Reinstating first reading Amendment 191.
Člen 59 – odstavek 1 – pododstavek 7
Article 59 – paragraph 1 – subparagraph 7
Študija se tudi zaščiti, če je bilo to potrebno za podaljšanje ali pregled registracije.
A study shall also be protected if it was necessary for the renewal or review of an authorisation.
Obdobje varovanja podatkov je 30 mesecev.
The period for data protection shall be 30 months.
Prvi do četrti pododstavek se uporablja z ustreznimi spremembami.
The first to fourth subparagraphs shall apply with due changes.
Študija se ne zaščiti, če je bilo to potrebno za podaljšanje ali pregled registracije.
A study shall not be protected if it was necessary for the renewal or review of an authorisation.
Člen 60 – odstavka 1 in 2
Article 60 - paragraphs 1 and 2
Država članica poročevalka za vsako aktivno snov, varovalo, sinergist in pomožno sredstvo pripravi seznam poročil o preskusih in študijah, potrebnih za prvo odobritev, spremembo pogojev za odobritev ali podaljšanje odobritve , in ga da na voljo državam članicam in Komisiji .
For each active substance, safener and synergist and adjuvant , rapporteur Member States shall prepare a list of the test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval and make it available to the Member States and the Commission.
Država članica poročevalka za vsako aktivno snov, varovalo, sinergist in pomožno sredstvo Agenciji posreduje seznam poročil o preskusih in študijah, potrebnih za prvo odobritev, spremembo pogojev za odobritev ali podaljšanje odobritve ter povzetek rezultatov preskusov in poročil o študijah, da se preveri učinkovitost snovi ter njena neškodljivost za ljudi, živali, rastline in okolje, Agencija pa ju da na voljo javnosti v času objave osnutka poročila o oceni v skladu s členom 12 .
For each active substance, safener and synergist and adjuvant, rapporteur Member States shall forward to the Authority, who shall make available to the public at the moment of publishing the draft assessment report in accordance with Article 12 , a list of the test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval and a summary of the results of the test and study reports to establish the efficacy of the substance and its harmlessness to humans, animals, plants and the environment.
Na zahtevo katere koli zainteresirane strani dajo države članice za vsako fitofarmacevtsko sredstvo, ki ga registrirajo, hranijo in dajo na voljo:
For each plant protection product which they authorise, Member States shall keep and make available to any interested party upon request :
Države članice za vsako fitofarmacevtsko sredstvo, ki ga registrirajo, Agenciji posredujejo, Agencija pa da javnosti v času objave osnutka poročila o oceni v skladu s členom 12 na voljo:
For each plant protection product which they authorise, Member States shall forward to the Authority, who shall make available to the public, at the moment of publishing the draft assessment report in accordance with Article 12 :
(a) seznam poročil o preskusih in študijah v zvezi z aktivno snovjo, varovalom ali sinergistom, pomožnim sredstvom in fitofarmacevtskim sredstvom, potrebnih za prvo registracijo, spremembo pogojev registracije ali podaljšanje registracije; ter
(a) a list of the test and study reports concerning the active substance, safener or synergist, adjuvant and the plant protection product necessary for first authorisation, amendment of the authorisation conditions or renewal of the authorisation; and
(b) seznam poročil o preskusih in študijah, v zvezi s katerimi je vlagatelj predložil zahtevo za varstvo podatkov v skladu s členom 59, in utemeljitve, predložene v skladu s tem členom .
(b) a list of test and study reports for which the applicant claimed data protection under Article 59 and any reasons submitted in accordance with that Article.
(b) seznam poročil o preskusih in študijah, v zvezi s katerimi je vlagatelj predložil zahtevo za varstvo podatkov v skladu s členom 59, in utemeljitve, predložene v skladu s tem členom ;
(b) a list of test and study reports for which the applicant claimed data protection under Article 59 and any reasons submitted in accordance with that Article;
(ba) povzetek rezultatov preskusov in poročil o študijah, da se preveri učinkovitost sredstva ter njegova neškodljivost za ljudi, živali, rastline in okolje.
(ba) a summary of the results of the test and study reports to establish the efficacy of the product and its harmlessness to humans, animals, plants and the environment .
Ponovna vložitev predloga spremembe 299 s prve obravnave.
Reinstating first reading Amendment 299.
Člen 61 – odstavek -1 (novo)
Article 61 – paragraph -1 (new)
Vse osebe, ki imajo namen pridobiti registracijo za fitofarmacevtsko sredstvo, pred izvajanjem preskusov ali študij pregledajo bazo podatkov iz členov 35a in 57.
Any persons intending to seek an authorisation for a plant protection product shall, before carrying out tests or studies, consult the database referred to in Articles 3 5 a and 57.
Za zagotovitev najboljše izmenjave podatkov bi morali vlagatelji pregledati bazo podatkov Agencije in pridobiti vse informacije o preskusih in študijah, ki so bili predhodno izvedeni za namene te uredbe.
To ensure maximum data sharing, applicants should consult the Authority database in order to find all the necessary information on tests and studies carried out previously for the purposes of this Regulation.
Ponovna vložitev predloga spremembe 201 s prve obravnave.
Reinstating first reading Amendment 201.
Če ima pristojni organ države članice dokaz, da morebitni vlagatelj namerava vložiti zahtevek za registracijo, njeno podaljšanje ali pregled, mu zagotovi ime in naslov imetnika ali imetnikov obstoječih zadevnih registracij ter hkrati sporoči imetnikom registracij ime in naslov vlagatelja.
The competent authority of the Member State, where satisfied that the prospective applicant intends to apply for an authorisation, or the renewal or review thereof, shall provide him with the name and address of the holder or holders of previous relevant authorisations and shall at the same time inform the holders of the authorisations of the name and address of the applicant.
Ponovna vložitev predloga spremembe 203 s prve obravnave.
Reinstating first reading Amendment 203.
Člen 61 – odstavek 3
Article 61 – paragraph 3
Morebitni vlagatelj registracije in imetnik ali imetniki zadevnih registracij sprejmejo vse ustrezne ukrepe za dosego dogovora o izmenjavi poročil o preskusih in študijah, varovanih v skladu s členom 59, 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 59 that are required by the applicant for authorisation of a plant protection product.
Morebitni vlagatelj registracije , njenega podaljšanja ali pregleda, in imetnik ali imetniki zadevnih registracij sprejmejo vse ustrezne ukrepe za dosego dogovora o izmenjavi poročil o preskusih in študijah, varovanih v skladu s členom 59, ki jih zahteva vlagatelj za registracijo fitofarmacevtskega sredstva, za njeno podaljšanje ali pregled .
The prospective applicant for the authorisation, or the renewal or review thereof, 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 59 that are required by the applicant for the authorisation , or the renewal or review thereof , of a plant protection product.
Da bi zagotovili, da bodo stroški razširjanja informacij izračunani pravično, pregledno in nediskriminatorno, lahko Komisija na podlagi teh načel v skladu z regulativnim postopkom, navedenem v členu 79(3), sprejme 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 regulatory procedure referred to in Article 79 (3), adopt cost-sharing guidelines based on those principles.
Da bi zmanjšali nepotrebno podvajanje preskusov, je treba vzpostaviti mehanizme arbitraže in delitve stroškov, ki bodo vlagateljem in imetnikom registracij pomagali pri dogovarjanju.
In order to minimise unnecessary duplication of tests, it is necessary to put in place arbitration- and cost-sharing mechanisms that could help applicants and holders of authorisation to reach an agreement.
Ponovna vložitev predloga spremembe 204 s prve obravnave.
Reinstating first reading Amendment 204.
Člen 61 – odstavek 3 a (novo)
Article 61 – paragraph 3 a (new)
Kadar država članica meni, da bi lahko nastal monopol, morebitni vlagatelj in imetnik ali imetniki registracij fitofarmacevtskih sredstev, ki vsebujejo enako aktivno snov, varovalo ali enak sinergist, pa se ne morejo sporazumeti o izmenjavi preskusov in študij, ki vključujejo vretenčarje, morebitni vlagatelj o tem obvesti pristojni organ države članice.
Where the Member State considers that a monopoly might be created, and the prospective applicant and the holder or holders of the authorisations for plant protection products containing the same active substance, safener, or synergist cannot reach agreement on the sharing of any tests and studies involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State to that effect.
Kljub temu pa se morata obe strani dogovoriti o pristojnem sodišču za namene člena 62(4).
The two parties shall nevertheless agree which courts and tribunals have jurisdiction for the purposes of of Article 62 ( 4 ).
Ponovna vložitev predloga spremembe 205 s prve obravnave.
Reinstating first reading Amendment 205.
Člen 62 – odstavek 2
Article 62 ‑ paragraph 2
Morebitni vlagatelj in imetnik ali imetniki zadevnih registracij si prizadevajo za zagotovitev izmenjave preskusov in študij, ki vključujejo vretenčarje.
The prospective applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals.
Stroški izmenjave poročil o preskusih in študijah se določijo pošteno, pregledno in nediskriminatorno.
The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way.
Morebitni vlagatelj krije stroške , ki nastanejo v celotnem postopku za pridobitev informacij , ki jih mora predložiti za izpolnitev zahtev za registracijo.
The prospective applicant is required to share in the costs that accrue during the full process of generating the information he is required to submit to meet the authorisation requirements.
Ponovna vložitev predloga spremembe 207 s prve obravnave.
Reinstating first reading Amendment 207.
Člen 62 – odstavek 3 a (novo)
Article 62 ‑ paragraph 3 a (new)
Oceno in vse predloge sprememb za omejitev varstva podatkov o preskusih na živalih predloži Evropskemu parlamentu in Svetu.
The Commission shall submit this assessment, and any proposed amendments for limiting the data protection with regard to animal experiments, to the European Parliament and the Council.
Tudi manj strog režim varovanja podatkov bo zmanjšal število preskusov na vretenčarjih.
A less strict data protection regime will still reduce the number of tests on vertebrate animals.
Ponovna vložitev predloga spremembe 208 s prve obravnave.
Reinstating first reading Amendment 208.
Člen 63 – odstavek 2 – uvodni del
Article 63 – paragraph 2 - introductory part
Za razkritje naslednjih informacij običajno velja, da ogroža zaščito poslovnih interesov ali zasebnosti in integriteto zadevnega posameznika:
Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or of privacy and the integrity of the individuals concerned:
Za razkritje naslednjih informacij velja, da ogroža zaščito poslovnih interesov ali zasebnosti in integriteto zadevnega posameznika:
Disclosure of the following information shall be deemed to undermine the protection of the commercial interests or of privacy and the integrity of the individuals concerned:
Izraz „običajno“ s pravnega vidika ni opredeljen in omogoča arbitrarnost.
From a legal point of view “normally” is undefined and opens the door for arbitrariness.
Člen 63 – odstavek 2 a (novo)
Article 63 ‑ paragraph 2 a (new)
Ponovna vložitev predloga spremembe 211 s prve obravnave.
Reinstating first reading Amendment 211.
Člen 65 – odstavek 3 a (novo)
Article 65 ‑ paragraph 3 a (new)
Prehrambeni izdelki, ki niso v skladu z določbami Direktive Komisije 2006/125/ES z dne 5. decembra 2006 o žitnih kašicah ter hrani za dojenčke in majhne otroke 1 , se označijo z oznako „ni primerno za dojenčke in majhne otroke“.
Food products which do not comply with the provisions of Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children 1 shall be labelled "not suitable for infants and young children".
Ponovna vložitev predloga spremembe 214 s prve obravnave.
Reinstating first reading Amendment 214.
Člen 66 – odstavek 2 a (novo)
Article 66 ‑ paragraph 2 a (new)
Ponovna vložitev predloga spremembe 215 s prve obravnave.
Reinstating first reading Amendment 215.
Člen 67 – odstavek 1
Article 67 ‑ paragraph 1
Proizvajalci, dobavitelji, distributerji, uvozniki, izvozniki in poklicni uporabniki fitofarmacevtskih sredstev najmanj tri leta vodijo evidenco v zvezi s fitofarmacevtskimi sredstvi, ki jih proizvajajo, uvažajo, izvažajo, skladiščijo, uporabljajo ali dajejo v promet.
Producers, suppliers, distributors , importers, exporters and professional users of plant protection products shall keep records of the plant protection products they produce, import, export, store, use or place on the market for at least three years.
Proizvajalci, dobavitelji, distributerji, uvozniki, izvozniki in poklicni uporabniki fitofarmacevtskih sredstev najmanj deset let po prekinitvi proizvodnje ali uporabe vodijo evidenco v zvezi s fitofarmacevtskimi sredstvi, ki jih proizvajajo, uvažajo, izvažajo, skladiščijo, uporabljajo ali dajejo v promet.
Producers, suppliers, distributors, importers, exporters and professional users of plant protection products shall keep records of the plant protection products they produce, import, export, store, use or place on the market for at least ten years after the end of production or use.
Tretje strani, kot je sektor za gospodarjenje s pitno vodo, lahko od pristojnega organa zahtevajo dostop do teh informacij .
Third parties such as the drinking water industry may request access to this information by addressing the competent authority.
Ti podatki morajo biti na voljo tudi sosedom, prebivalcem, trgovcem na drobno ali sektorju za gospodarjenje s pitno vodo, če zahtevajo neposreden dostop do njih .
They shall also keep this information available for neighbours and residents, retailers or the drinking water industry who request direct access to it.
Podatki o celotni uporabi fitofarmacevtskih sredstev na določenem kmetijskem izdelku se zagotovijo trgovcem na drobno in na debelo v standardiziranem formatu.
The information on all applications of plant protection products on a given agricultural product shall be provided to retailers and wholesalers using a standardised format.
Standardizirani format za zagotavljanje podatkov iz prejšnjega pododstavka se uvede v skladu s svetovalnim postopkom iz člena 79(2).
The standardised format for the provision of the information referred to in the subparagraph above shall be established in accordance with the advisory procedure referred to in Article 79(2).
Člen 67 – odstavek 1 a (novo)
Article 67 ‑ paragraph 1 a (new)
Ponovna vložitev predloga spremembe 217 s prve obravnave.
Reinstating first reading Amendment 217.
Člen 77
Article 77
Komisija lahko, v skladu s svetovalnim postopkom iz člena 79(2) , sprejme ali spremeni tehnične ali druge smernice za izvajanje te uredbe.
The Commission may, in accordance with the advisory procedure referred to in Article 79(2) , adopt or amend technical and other guidance documents for the implementation of this Regulation.
Komisija lahko, v skladu z regulativnim postopkom iz člena 79(3) , sprejme ali spremeni tehnične ali druge smernice za izvajanje te uredbe.
The Commission may, in accordance with the regulatory procedure referred to in Article 79 ( 3 ), adopt or amend technical and other guidance documents for the implementation of this Regulation.
Kompromisni predlog spremembe, ki temelji na predlogu spremembe 224 iz prve obravnave.
Compromise amendement based on first reading Amendment 224.
Člen 78 – odstavek 1 – točka f
Article 78 – paragraph 1 – point (f)
(f) uredba o pripravi programa dela za varovala in sinergiste iz člena 26;
(f) a Regulation establishing a work program for safeners and synergists referred to in Article 26;
Program dela bi bilo treba sprejeti s postopkom soodločanja.
This work programme should be adopted in codecision.
Predlog spremembe novega odstavka, ki ga predlaga Svet v skladu s predlogom spremembe 108 iz prve obravnave.
Amendment of a new paragraph introduced by Council, in line with amendment 108 of first reading.
Člen 78 – odstavek 3
Article 78 ‑ paragraph 3
V skladu s svetovalnim postopkom iz člena 79(2) se sprejme uredba, ki vsebuje seznam aktivnih snovi iz Priloge I k Direktivi 91/414/EGS.
In accordance with the advisory procedure referred to in Article 79(2) , a Regulation shall be adopted containing the list of active substances included in Annex I to Directive 91/414/EEC.
V skladu z regulativnim postopkom s pregledom iz člena 79(4) se sprejme uredba, s katero se seznam aktivnih snovi iz Priloge I k Direktivi 91/414/EGS vključi v Prilogo IIa k tej uredbi .
In accordance with the regulatory procedure with scrutiny referred to in Article 7 9 ( 4 ), a Regulation shall be adopted incorporating the list of active substances included in Annex I to Directive 91/414/EEC into Annex IIa of this Regulation .
Ponovna vložitev predloga spremembe 226 iz prve obravnave ter dodatna sprememba, da se zagotovi skladnost s predlogom spremembe člena 13(2), ki določa prilogo k seznamu aktivnih snovi.
Reinstating first reading Amendment 226, plus an additional modification to ensure coherence with the amendment to Article 13(2) which establishes an annex for the list of active substances.
Člen 80 – odstavek 7
Article 80 – paragraph 7
Komisija v … pripravi seznam snovi, vključenih v Prilogo I k Direktivi 91/414/EGS, ki izpolnjujejo merila, določena v točki 4 Priloge II k tej uredbi, in za katera se uporabljajo določbe člena 50 te uredbe.
By …*, the Commission shall establish a list of substances included in Annex I of Directive 91/414/EEC which satisfy the criteria set out in point 4 of Annex II to this Regulation and to which the provisions of Article 50 of this Regulation shall apply.
Komisija v … * pripravi seznam snovi, vključenih v Prilogo I k Direktivi 91/414/EGS, ki izpolnjujejo merila, določena v točki 4 Priloge II k tej uredbi, in za katere se uporabljajo določbe člena 50 te uredbe.
By …*, the Commission shall establish a list of substances included in Annex I of Directive 91/414/EEC which satisfy the criteria set out in point 4 of Annex II to this Regulation and to which the provisions of Article 50 of this Regulation shall apply.
* Opomba UL : 78 mesecev od datuma začetka veljavnosti te uredbe.
* Note to OJ: 78 months from the date of entry into force of this Regulation.
* Opomba UL: 36 mesecev od datuma začetka veljavnosti te uredbe.
* Note to OJ: 36 months from the date of entry into force of this Regulation.
Ni razloga, da bi za sprejetje seznama možnih snovi za zamenjavo čakali šest let in pol.
There is no good justification to wait for six and a half years to adopt the list of substances that are candidates for substitution.
To je treba storiti najpozneje po treh letih.
This should be done after 3 years at the latest.
Predlog spremembe novega odstavka, ki ga je predlagal Svet.
Amendment of new paragraph introduced by Council.
Člen 82
Article 82
Do…, Komisija Evropskemu parlamentu in Svetu predloži poročilo o delovanju medsebojnega priznavanja registracij ter zlasti o uporabi določb iz člena 36(3) in člena 50(2) s strani držav članic , o razdelitvi držav članic Skupnosti na tri cone in uporabi meril za odobritev aktivnih snovi, varoval in sinergistov v skladu s Prilogo II ter o njihovem vplivu na diverzifikacijo in konkurenčnost kmetijskega sektorja ter na zdravje ljudi in na okolje.
By ...*, the Commission shall present a report to the European Parliament and the Council on the functioning of mutual recognition of authorisations and in particular on the application by the Member States of the provisions referred to in Article 36(3) and Article 50(2) , the division of the Community into three zones and on the application of the criteria for the approval of active substances, safeners and synergists as set out in Annex II and the impact thereof on the diversification and competitiveness of agriculture as well as on human health and on the environment.
Poročilu lahko po potrebi predloži ustrezne zakonodajne predloge za spremembo teh določb.
The report may be accompanied, if necessary, by the appropriate legislative proposals to amend those provisions.
Do… * , Komisija Evropskemu parlamentu in Svetu predloži poročilo o delovanju medsebojnega priznavanja registracij ter zlasti o uporabi določb iz člena 36(2a) in (3) in člena 50(2) s strani držav članic in uporabi meril za odobritev aktivnih snovi, varoval in sinergistov v skladu s Prilogo II ter o njihovem vplivu na diverzifikacijo in konkurenčnost kmetijskega sektorja , na cene hrane ter na zdravje ljudi in na okolje.
By ...*, the Commission shall present a report to the European Parliament and the Council on the functioning of mutual recognition of authorisations and in particular on the application by the Member States of the provisions referred to in Article 36(2a) and (3) and Article 50(2) and on the application of the criteria for the approval of active substances, safeners and synergists as set out in Annex II and the impact thereof on the diversification and competitiveness of agriculture , including on food prices, as well as on human health and on the environment.
PRILOGA I
Annex I
Cona A – sever
Zone A – North
V to cono sodijo naslednje države članice:
The following Member States belong to this zone:
Cona B – osrednji del
Zone B – Centre
Belgija, Češka, Nemčija, Irska, Luksemburg, Madžarska, Nizozemska, Avstrija, Poljska, Romunija, Slovenija, Slovaška, Združeno kraljestvo
Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Romania, Slovenia, Slovakia, United Kingdom
Cona C – jug
Zone C – South
Ponovna vložitev predloga spremembe 230 s prve obravnave.
Reinstating first reading Amendment 230.
Priloga II – točka 3.6.1
Annex II ‑ point 3.6.1
Kjer je to ustrezno, se določijo ADI, AOEL in ARfD.
Where relevant, an ADI, AOEL and ARfD shall be established.