natgillin/translations-raw huggingface dataset:
Glede drugih vidikov sestave so razlike dovoljene pod pogojem, da te razlike v kakovosti in količini v pomožnih snoveh ne vplivajo na biološko aktivnost, na rastline, ki bodo obdelane, ali na človeka, živali ali naravo.
As regards other aspects of composition, differences are permissible providing these qualitative or quantitative differences in the co-formulants have no impact on biological efficacy, the plants to be treated or human beings, animals or on nature.
V skladu s postopkom iz člena 76(2) se lahko merila in postopki za preverjanje snovne enakosti uredijo bolj podrobno.
Under the procedure referred to in Article 76(2), the crite ria and the procedure for verifying compositional equivalence may be regulated in greater detail.
Zahtevku za izdajo potrdila o tržljivosti se priložijo naslednje informacije:
The application for the issue of a marketability certificate shall contain the following information:
– država članica izvora fitofarmacevtskega sredstva, ki bo uvoženo,
– the Member State of origin of the plant protection product to be imported;
– ime in oznaka uvoznika,
– the name and address of the importer;
– oznaka, s katero se bo fitofarmacevtsko sredstvo, ki bo uvoženo, prodajalo v državi uvoza,
– the designation under which the imported plant protection product is to be marketed in the importing country;
– oznaka in številka odobritve fitofarmacevtskega sredstva, ki bo uvoženo, v državi članici izvora,
– the designation and approval number in the Member State of origin of the plant protection product to be imported;
– oznaka in številka registracije referenčnega sredstva,
-the designation and authorisation number of the reference product;
Fitofarmacevtsko sredstvo, za katerega je bilo izdano potrdilo o tržljivosti, se uporablja enako kot referenčno sredstvo.
A plant protection product for which a marketability certificate has been issued shall be used in the same manner as the reference product.
Če imetnik registracije referenčnega sredstva v skladu s členom 44(1) zahteva preklic registracije in če so zahteve iz člena 29 še vedno izpolnjene, se veljavnost potrdila o tržljivosti preneha eno leto po preklicu registracije in najkasneje ob poteku veljavnosti registracije.
If the authorisation holder of the reference product applies, pursuant to Article 44(1), for authorisation to be withdrawn and if the requirements under Article 29 continue to be met, the validity of the marketing certificate shall end one year after the revocation of the authorisation, and, at the latest, when the authorisation has expired.
Predpisi iz členov 43, 45 in 53(4) poglavja VII se ustrezno uporabljajo za vzporedni uvoz.
The provisions of Articles 43, 45 and 53(4) and Chapter VII shall apply, mutatis mutandis, to parallel imports.
Zaradi odprave sedanje pravne negotovosti pa je nujno potrebna pravna ureditev na ravni EU.
However, legal provisions are urgently needed at EU level in order to put an end to the existing legal uncertainty.
V letu 1996 je moral Evropski parlament na sodišče, ker prva enotna načela, ki jih je določila Komisija, niso bila v skladu z Uredbo 97/414/EGS.
In 1996 the European Parliament had to go to Court because the first Uniform Principles which were established by the Commission did not comply with Directive 91/414.
Uredbo, s katero se določajo nova enotna načela, bi morala Evropski parlament in Svet sprejeti v ustreznem zakonodajnem postopku, ne bi se pa smela sprejemati v postopku komitologije.
The Regulation establishing the new Uniform Principles should be adopted by the European Parliament and the Council in an adequate legislative procedure, and not by Comitology.
Člen 30, odstavek 3, točka (b)
Article 30, paragraph 3, point (b)
(b) obveznost obveščanja vseh sosedov, ki bi lahko bili izpostavljeni zanašanju škropiva, pred uporabo sredstva, in ki so zahtevali, da se jih obvesti.
(b) the obligation to inform any neighbours who could be exposed to the spray drift before the product is used and who have requested to be informed.
Država članica, ki preučuje zahtevek, opravi neodvisno, objektivno in pregledno oceno glede na sedanji znanstvene in tehnične dosežke.
The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge.
Država članica, ki preučuje zahtevek, opravi neodvisno, objektivno in pregledno oceno glede na znanstvene in tehnične dosežke ter smernice, ki obstajajo v času vložitve zahtevka .
The Member State examining the application shall make an independent, objective and transparent assessment in the light of scientific and technical knowledge and guidance existing at the time of application.
Dajanje fitofarmacevtskih sredstev v promet je zelo pomembna naložba.
Placing new plant protection products on the market is a very significant investment.
Zadevne države članice ustrezno izdajo ali zavrnejo registracijo na podlagi sklepov ocene države članice, ki preučuje zahtevek, kot je predvideno v členih 30 in 31.
The Member States concerned shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 30 and 31.
Države članice pod enakimi pogoji odobrijo zadevno fitofarmacevtsko sredstvo, vključno z razvrstitvijo za namene Direktive 1999/45/ES, kot država članica, ki preučuje zahtevek.
The Member States shall authorize the plant protection product concerned under the same conditions, including classification for the purpose of Directive 1999/45/EC, as the Member State examining the application.
Države članice , kjer je to mogoče, pod enakimi pogoji odobrijo zadevno fitofarmacevtsko sredstvo kot država članica, ki preučuje zahtevek , razen če je treba upoštevati drugačne pogoje uporabe, in sicer neprimerljive pogoje glede kmetijstva, zdravja rastlin ali okolja.
The Member States shall , where possible , authorise the plant protection product concerned under the same conditions, as the Member State examining the application, unless different conditions of use need to be taken into consideration, taking into account non-comparable agricultural, plant health or environmental conditions.
Če smejo države članice pri registraciji proizvodov upoštevati lokalne razmere, ta določba ni potrebna.
This provision is unnecessary if Member States are allowed to take local conditions into account when authorising products .
Imetnik registracije lahko zaprosi za registracijo istega fitofarmacevtskega sredstva in za isto uporabo v drugi državi članici, v skladu s postopkom vzajemnega priznavanja iz tega pododdelka, če:
The holder of an authorisation may apply for an authorisation for the same plant protection product and for the same use in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases:
Imetnik registracije ali oseba, ki jo imetnik imenuje za svojega zastopnika, lahko zaprosi za registracijo istega fitofarmacevtskega sredstva in za isto uporabo v drugi državi članici, v skladu s postopkom vzajemnega priznavanja iz tega pododdelka, če:
The holder of an authorisation or a person designated by that person as his representative may apply for an authorisation for the same plant protection product and for the same use in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases:
(a) je registracijo izdala država članica (referenčna država članica), ki pripada istemu območju; ali
(a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone; or
(b) je registracijo izdala država članica za uporabo v rastlinjakih ali za obdelavo po tem, ko se pridelek pobere, ne glede na območje , v katerega spada referenčna država članica.
(b) the authorisation was granted by a Member State for use in greenhouses or as post-harvest treatment, regardless of the zone to which the reference Member State belongs.
(b) je registracijo izdala država članica za uporabo v rastlinjakih ali za obdelavo po tem, ko se pridelek pobere, ali za obdelavo semen ne glede na območje, v katerega spada referenčna država članica ;
(b) the authorisation was granted by a Member State for use in greenhouses or as post-harvest treatment or as a seed treatment , regardless of the zone to which the reference Member State belongs ;
ter na prostovoljni osnovi med državami članicami, ki spadajo na različna območja s podobnimi pogoji glede kmetijstva, zdravja rastlin in okolja, zlasti pa glede podnebnih razmer, ki so za uporabo tega proizvoda pomembne.
and on a voluntary basis between Member States in different zones having similar conditions in relation to agriculture, plant health and the environment, in particular climatic conditions relevant to the use of the product .
Vzajemno priznavanje ne velja za fitofarmacevtska sredstva, ki vsebujejo možne nadomestne snovi.
Mutual recognition shall not apply to plant protection products containing a candidate for substitution.
Če se postopek vzajemnega priznavanja ne bo več uporabljal za proizvode, ki vsebujejo možne nadomestne snovi, bo to ogrozilo doseganje enega od ciljev usklajevanja.
If the mutual recognition procedure is no longer available for products containing a candidate for substitution, the achievement of one of the objectives of harmonisation will be jeopardised.
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 je treba upoštevati drugačne pogoje uporabe, in sicer neprimerljive pogoje glede kmetijstva, zdravja rastlin ali okolja.
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 different conditions of use need to be taken into consideration, taking into account non-comparable agricultural, plant health or environmental conditions.
Kadar država članica, ki ji je predložen zahtevek v skladu s členom 39, želi odobriti zadevno fitofarmacevtsko sredstvo pod drugačnimi pogoji kot referenčna država članica, država članica nemudoma obvesti Komisijo o drugačnih pogojih in navede podrobne informacije o razlogih za odstopanje.
Where a Member State to which an application under Article 39 is submitted wishes to authorise the plant protection product concerned under different conditions than the reference Member State, the Member State shall immediately inform the Commission of the different conditions and provide detailed information about the reasons for the divergence.
Komisija pregleda registracijo zadevne države članice.
The Commission shall review the authorisation of the Member State concerned.
Kadar meni, da ni razlogov za odstopanje, zadevno državo članico pozove, naj zadevno fitofarmacevtsko sredstvo odobri pod enakimi pogoji kot referenčna država članica.
Where it considers that there are no reasons for the divergence it shall call on the Member State concerned to authorise the plant protection product under the same conditions as the reference Member State .
Kmetijske in podnebne razmere ter varstvo pred škodljivci se med državami razlikujejo.
Agricultural and climatic conditions as well as pest pressure vary across countries.
Države članice bi zato morale imeti možnost, da pri odobritvi proizvodov na svojem lastnem ozemlju upoštevajo lokalne razmere.
Therefore, Member States should be allowed to take into account local conditions when approving products on their own territory.
Zagotovljena bi morala biti zaščita pred zlorabo vzajemnega priznavanja s strani držav članic.
There should be safeguards against the misuse of the mutual recognition by Member States.
Člen 42, odstavek 3, točki (a) in (b)
Article 42, paragraph 3, points (a) and (b)
(b) utemeljitev, da so novi predloženi podatki rezultat zahtev po podatkih ali merilih , ki niso veljale , ko je bila izdana registracija za fitofarmacevtsko sredstvo;
(b) justification that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted;
(b) utemeljitev, da so novi predloženi podatki rezultat zahtev po podatkih ali meril , ki niso veljali , ko je bila izdana registracija za fitofarmacevtsko sredstvo , oziroma so bili potrebni za spremembo pogojev za odobritev ;
(b) justification that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of the approval;
Pojasnilo glede podatkov, ki jih je treba varovati po obnovitvi registracije aktivne snovi.
Clarification regarding the data that is to be protected after the renewal of the active substance authorisation.
Če namerava država članica preklicati ali spremeniti registracijo, o tem obvesti imetnika registracije in mu da možnost, da predloži pripombe.
Where a Member State intends to withdraw or amend an authorisation , it shall inform the authorisation holder and give him the possibility to submit comments.
Država članica prekliče ali spremeni registracijo, kot je primerno, če:
The Member State shall withdraw or amend the authorisation , as approp ria te, where:
Država članica lahko od imetnika registracije zahteva, da predloži dodatne podatke.
The Member State may ask the authorisation holder to submit further information.
(a) zahteve iz člena 29 niso ali niso več izpolnjene;
(a) the requirements referred to in Article 29 are not or are no longer satisfied;
(b) so bile predložene napačne ali zavajajoče informacije o dejstvih, na podlagi katerih je bila izdana registracija;
(b) false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted;
(c) imetnik registracije ni izpolnil pogoja iz registracije.
(c) a condition included in the authorisation has not been met by the authorisation holder.
(c) pogoj iz registracije ni bil izpolnjen.
(c) a condition included in the authorisation has not been met.
Člen 45 se uporablja po potrebi.
Article 45 shall apply where approp ria te.
Če država članica po uporabi odstavka 3 še vedno namerava preklicati ali spremeniti registracijo v skladu z odstavkom 2 , o tem nemudoma obvesti imetnika registracije, druge države članice, Agencijo in Komisijo.
Where a Member State still intends, after application of paragraph 3, to withdraw or amend an authorisation in accordance with paragraph 2 , it shall immediately inform the holder of the authorisation, the other Member States, the Authority and the Commission.
Posamezne zlorabe bi morale biti podvržene korektivnim ukrepom, vendar ne bi smele sistematično voditi do preklica registracije, kot je predvideno v odstavku 2(c).
Individual misuse should be subject to corrective measures but should not systematically lead to the revocation of the authorisation as implied in paragraph 2(c).
Razlogi, zaradi katerih se ena država članica odloči za preklic registracije, ne veljajo nujno za vse ostale države članice na območju.
Reasons triggering authorization withdrawal by one Member State do not necessarily apply to all other Member States within the zone.
Zato bi morale druge države članice imeti možnost, da ohranijo registracijo, vse dokler so izpolnjene zahteve iz člena 4.
Therefore, other Member States should be allowed to retain the authorization as long as the requirements of Article 4 are met.
Člen 48, odstavek 1
Article 48, paragraph 1
(b) nadomestitev s fitofarmacevtskimi sredstvi ali kontrolnimi ali preventivnimi metodami brez uporabe kemikalij iz točke (a) ne povzroča bistvene gospodarske ali praktične izgube;
(b) the substitution by plant protection products or non-chemical control or prevention methods referred to in point (a) does not present significant economic or practical disadvantages;
V procesu primerjalnega ocenjevanja je treba zagotoviti, da morebitne alternative pri ravnanju s škodljivci izkazujejo enako učinkovitost.
During the comparative assessment process it has to be ensured that a possible alternative shows equivalent efficacy in treating the pest problem.
Člen 49, odstavek 5, pododstavka 2 a in 2 b (novo)
Article 49, paragraph 5, subparagraphs 2 a and 2 b (new)
V teh informacijah mora biti izrecno navedeno, da preverjanje učinkovitosti sredstva na zahtevanem področju uporabe in morebitna škoda na poljščinah načeloma nista predmet postopka registracije.
This information must specifically state that the verification of the efficacy of the substance in the field of application applied for and possible damage to crops are, as a matter of principle, not the subject of the authorisation procedure.
Poleg tega mora biti imetnik registracije v teh informacijah izrecno oproščen vsakršne odgovornosti za morebitno škodo zaradi nezadostne učinkovitosti ali škodo na poljščinah.
Furthermore, this information must also specifically exempt the authorisation holder from any liability for possible damage due to insufficient efficacy or damage to crops.
Vprašanje odgovornosti je ključnega pomena za delovanje postopka za ugotavljanje pomanjkljivosti.
The question of liability is of key importance for the operation of the deficiency indication procedure.
Proizvajalci bi morali biti oproščeni odgovornosti izključno na področjih, pri katerih je preverjanje po tem postopku manj temeljito kot v navadnem postopku registracije (glej člen 4, odstavka 3a in 3c, ki se jih v primeru razširitve v skladu s členom 49 ne sme ocenjevati).
Producers should be exempt from liability exclusively for those areas which are tested under this procedure less thoroughly than in the normal authorisation procedure (see Article 4, paragraphs 3a and 3c, which must not be assessed in the event of an extension under Article 49).
Države članice hranijo posodobljen seznam registracij za uporabe v manjši meri in ga dajo na razpolago javnosti v elektronski obliki.
Member States shall keep an up-to-date list of authorisations for minor uses and shall make it available to the public in electronic form.
Za preprečitev podvajanja in pospešitev registracije uporab v manjši meri bi morale države članice narediti posodobljen seznam registriranih uporab v manjši meri.
To avoid duplication, and to speed up the authorisation of minor uses, Member States should establish an up-to-date list of the minor uses authorised in their country.
Seznam, ki je javnosti dostopen v elektronski obliki, zainteresiranim stranem omogoča hitro pridobitev informacij o dovoljenih uporabah v manjši meri v različnih državah članicah.
If this list is made available to the public in electronic form, interested parties can rapidly obtain information on the authorised minor uses in the various Member States.
To bo olajšalo izpolnjevanje posebnih potreb, ki opravičujejo registracijo za uporabo v manjši meri.
This will make it easier to comply with the special needs justifying an authorisation for a minor use.
Začasna nacionalna registracija
Provisional national authorisation
Z odstopanjem od določb člena 28 lahko država članica s ciljem omogočiti lažji dostop uporabnikov do novih fitosanitarnih sredstev dovoli dajanje fitosanitarnega sredstva v promet za največ tri leta, če iz tehničnih razlogov dve leti in pol po predložitvi zahtevka v skladu s členom 7(1) ni bila sprejeta nobena odločitev glede aktivne snovi in ne obstajajo indici o škodljivosti aktivne snovi ali fitosanitarnega sredstva.
Notwithstanding the provisions of Article 28, a Member State acting with the aim of facilitating the access of users to new plant protection products may authorise the marketing of a plant protection product for a period of not more than three years if, for technical reasons, t wo and a half years after submission of the application pursuant to Article 7(1) no decision has yet been made on the active substance and there is no indication that the active substance or the plant product may be harmful.
Člen 52, odstavek 1 a (novo)
Article 52, paragraph 1 a (new)
Ustrezna uporaba vključuje vsaj:
Proper use shall include , as a minimum:
(i) skladnost z zahtevami in pogoji, določenimi v skladu s členom 30 in navedenimi na oznaki v skladu z določbami o označevanju iz členov 61 in 63 ter v skladu z Direktivo 1999/45/EGS;
(i) compliance with the requirements and conditions established in accordance with Article 30 and specified on the labelling, in accordance with the labelling provisions of Articles 61 and 63 and with Directive 1999/45/EEC;
(ii) skladnost z Uredbo (ES) št. 396/2005;
(ii) compliance with Regulation (EC) No 396/2005;
(iii) skladnost z zahtevami direktiv o varstvu delavcev.
(iii) compliance with the requirements of the Directives on the protection of workers .
Opredelitev pravilne uporabe bi morala navajati najnujnejše zahteve.
The definition of proper use should indicate minimum requirements.
Poleg tega bi morala opozarjati tudi na potrebo po spoštovanju ustrezne zakonodaje Skupnosti.
It should also include the need for respecting specific Community legislation.
Člen 56, odstavek 1
Article 56, paragraph 1
Za poročila o preskusih in študijah velja varstvo podatkov v skladu s pogoji iz tega člena.
Test and study reports shall benefit from data protection under the conditions laid down in this Article.
Varstvo se uporablja za poročila o preskusih in študijah, ki jih je državi članici predložil vlagatelj registracije v skladu s to uredbo (v nadaljnjem besedilu „prvi vlagatelj“), če so bila ta poročila o preskusih in študijah
The protection applies to test and study reports submitted to a Member State by an applicant for authorisation under this Regulation (hereinafter called ‘the first applicant’), provided that those test and study reports were
(a) potrebna za registracijo ali spremembo registracije, da se odobri uporaba drugega pridelka , in
(a) necessary for the authorisation or an amendment of an authorisation in order to allow the use on another crop, and
potrebna za registracijo v danih pogojih ali spremembo registracije, da se odobri uporaba drugega pridelka.
necessary for the authorisation of the given conditions or an amendment of an authorisation in order to allow the use on another crop .
(b) potrjena kot skladna z načeli dobre laboratorijske prakse ali dobre preskusne prakse v skladu z zahtevami po podatkih za fitofarmacevtska sredstva iz člena 8(1)(c).
(b) certified as compliant with the principles of Good Laboratory Practice or Good Experimental Practice in accordance with the data requirements for plant protection products referred to in Article 8(1)(c).
Če je poročilo zaščiteno, ga država članica, ki ga je prejela, ne sme uporabljati v korist drugih vlagateljev za fitofarmacevtska sredstva, razen v skladu z določbami iz člena 59(2) ali člena 77.
Where a report is protected, it may not be used, by the Member State which received it, for the benefit of other applicants for plant protection products, except as provided in paragraph 2, in Article 59 or in Article 77.
Če je poročilo zaščiteno, država članica, ki ga je prejela, ali katera koli druga država članica ne sme uporabljati niti tega poročila niti njegovega povzetka v korist drugih vlagateljev za fitofarmacevtska sredstva, razen v skladu z določbami iz člena 59(2) ali člena 77.
Where a report is protected, neither it nor a summary of it may be used, by the Member State which received it or any other Member State , for the benefit of other applicants for plant protection products, except as provided in paragraph 2, in Article 59 or in Article 77.
Za fitofarmacevtska sredstva iz člena 46 se obdobje podaljša na 12 let,
That period is extended to 12 years for plant protection products covered by Article 46.