natgillin/translations-raw huggingface dataset:
Kadar so razlogi za preklic, spremembo ali zavrnitev podaljšanja registracije povezani z varovanjem zdravja ljudi in živali ter okolja, se za porabo zalog zadevnih fitofarmacevtskih sredstev ne določi roka, vsa prodaja in uporaba pa se prenehata takoj, ko se sprejme odločitev o zavrnitvi podaljšanja ali preklicu.
If the reasons for withdrawal, amendment or not renewing the authorisation are related to the protection of human and animal health or the environment then there shall be no time period for using up stocks of the plant protection products concerned and all sales and use of such products shall cease with immediate effect once the decision of withdrawal or non-renewal has been taken .
Kadar so razlogi za preklic, spremembo ali zavrnitev podaljšanja registracije povezani z varovanjem zdravja ljudi in živali ter okolja, je treba prodajo in uporabo tovrstnih pesticidov takoj prenehati.
Where the reasons for withdrawal, amendment or not renewing the authorization are related to the protection of human and animal health and the environment then the sale and use of such pesticides should cease with immediate effect.
Ponovna vložitev predloga spremembe 162 iz prve obravnave.
Reinstating first reaading Amendment 162.
Člen 46a
Article 4 6 a
Ne glede na določbe člena 46 se zaloge neregistriranih fitofarmacevtskih sredstev odlagajo varno, za uničenje pa je odgovoren imetnik nazadnje veljavne registracije.
Notwithstanding the provisions of Article 4 6 , stocks of unauthorised plant protection products shall be safely disposed of and destroyed under the responsibility of the former authorisation holder.
Ponovna vložitev predloga spremembe 163 s prve obravnave.
Reinstating first reading Amendment 163.
Člen 46b
Article 4 6 b
Da bi zaščitili človekovo zdravje in konkurenčnost evropske industrije, uvožene neživilske snovi ali predmeti ne smejo vsebovati aktivnih snovi, ki niso odobrene v EU.
In order both to protect human health and the competitiveness of the European industry, imported non-food materials or articles should not contain active substances that have not been approved in the EU.
Ponovna vložitev predloga spremembe 164 s prve obravnave.
Reinstating first reading Amendment 164.
Ne glede na določbe člena 29 je fitofarmacevtsko sredstvo označeno kot sredstvo z majhnim tveganjem, če so izpolnjene naslednje zahteve:
Notwithstanding Article 29, a plant protection product shall be authorised as a reduced - risk product if it meets the following requirements:
(a) vsaj ena od aktivnih snovi, ki jih vsebuje, je snov, ki je opredeljena v členu 22;
(a) at least one of the active substances that it contains is a substance as defined in Article 22;
(b) vse njegove aktivne snovi, varovala in sinergisti z majhnim tveganjem so bili odobreni v skladu s poglavjem II;
(b) all the low-risk active substances, safeners and synergists contain ed in it have been approved under Chapter II;
(d) je dovolj učinkovito;
(d) it is sufficiently effective ;
(e) je v skladu s členom 29(1)(b), (c) in (e) do (h).
(e) it complies with points ( b), (c) and (e) to (h) of Article 29(1) .
Vlagatelji za registracijo fitofarmacevtskega sredstva z manjšim tveganjem dokažejo, da so zahteve iz odstavka 1 izpolnjene, in k zahtevku priložijo popolno dokumentacijo in njen povzetek za vsako točko zahtev po podatkih o aktivni snovi in fitofarmacevtskem sredstvu.
A p plicants for authorisation of a reduced - risk plant protection product shall demonstrate that the requirements set out in paragraph 1 are met and shall accompany the application with a complete and a summary dossier for each point of the data requirements of 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 on whether to approve an application for authorisation of a reduced - risk plant protection product.
To obdobje traja 90 dni, če je za isto fitofarmacevtsko sredstvo z manjšim tveganjem druga država članica že izdala registracijo.
Th e period shall be 90 days where an authorisation has already been granted for the same reduced-risk plant protection product by another Member State .
Če država članica potrebuje dodatne informacije, določi rok, v katerem jih mora vlagatelj predložiti.
Where the Member State needs additional information, it shall set a time limit for the applicant to supply it .
V tem primeru se obdobje 120 dni podaljša za dodatno časovno obdobje, ki ga odobri država članica.
In that case the period of 120 days shall be extended by the additional time limit granted by the Member State .
Če ni drugače določeno, se uporabljajo vse določbe v zvezi z registracijami v skladu s to uredbo.
Unless otherwise specified , all provisions relating to authorisations under this Regulation shall apply.
Da bi spodbudili razvijanje manj škodljivih fitofarmacevtskih sredstev, se uvaja nova kategorija fitofarmacevtskih sredstev z majhnim tveganjem, ki povzročajo manjše tveganje kot sredstva, ki so že na trgu, in vsebujejo vsaj eno snov z majhnim tveganjem.
To encourage the development of less harmful plant protection products, this introduces a new category of low-risk plant protection products that present a lower risk than current products on the market and contain at least one low-risk active substance.
Ponovna vložitev predloga spremembe 168 s prve obravnave.
Reinstating first reading Amendment 168.
Člen 50 – odstavek 1 – uvod in točki a in b
Article 50 – paragraph 1 - introduction and points (a) and (b)
Primerjalno oceno izvedejo države članice, kadar ocenjujejo vlogo za registracijo fitofarmacevtskega sredstva, ki vsebuje aktivno snov, odobreno kot možno snov za zamenjavo.
A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product containing an active substance approved as a candidate for substitution.
Države članice ne registrirajo fitofarmacevtskega sredstva, ki vsebuje možno snov za zamenjavo, ali omejijo njegovo uporabo, če primerjalna ocena, ki preuči tveganja in koristi, kot je določeno v Prilogi IV, pokaže da:
Member States shall not authorise or shall restrict the use of a plant protection product containing a candidate for substitution where the comparative assessment weighing up the risks and benefits, as set out in Annex IV, demonstrates that:
Države članice ne registrirajo fitofarmacevtskega sredstva, ki vsebuje možno snov za zamenjavo, ali omejijo njegovo uporabo pri zadevnih kulturnih rastlinah , če primerjalna ocena, ki preuči tveganja in koristi, kot je določeno v Prilogi IV, pokaže da:
Member States shall not authorise or shall restrict the use of a plant protection product for use in a given crop containing a candidate for substitution where the comparative assessment weighing up the risks and benefits, as set out in Annex IV, demonstrates that:
(a) za načine uporabe, navedene v vlogi, že obstaja registrirano fitofarmacevtsko sredstvo, ali ne-kemična kontrolna ali preventivna metoda ki je bistveno varnejše za zdravje ljudi ali živali ali za okolje; ter
(a) for the uses specified in the application an authorised plant protection product, or a non-chemical control or prevention method, already exists which is significantly safer for human or animal health or the environment; and
(a) za načine uporabe, navedene v vlogi, že obstaja registrirano fitofarmacevtsko sredstvo, ali ne-kemična kontrolna ali preventivna metoda , ki je bistveno varnejše za zdravje ljudi ali živali ali za okolje; ter
(a) for the uses specified in the application an authorised plant protection product, or a non-chemical control or prevention method, already exists which is significantly safer for human or animal health or the environment; and
(b) fitofarmacevtsko sredstvo ali ne-kemična kontrolna ali preventivna metoda iz točke (a) ne pomeni bistvene gospodarske ali praktične izgube; ter
(b) the plant protection product or non-chemical control or prevention method referred to in point (a) does not present significant economic or practical disadvantages; and
(b) nadomestitev s fitofarmacevtskimi sredstvi ali ne-kemičnimi kontrolnimi ali preventivnimi metodami iz točke (a) ne pomeni bistvene gospodarske ali praktične izgube; ter
(b) the substitution by plant protection product s or non-chemical control or prevention method s referred to in point (a) does not present significant economic or practical disadvantages; and
(c) je kemijska raznolikost aktivnih snovi ustrezna za zmanjšanje nastanka odpornosti v ciljnem organizmu; ter
(c) the chemical diversity of the active substances is adequate to minimize the occurrence of resistance in the target organism; and
(c) so kemijska raznolikost aktivnih snovi , če je potrebno, ali metode in prakse pridelave kulturnih rastlin in zatiranja škodljivcev, ustrezne za zmanjšanje nastanka odpornosti v ciljnem organizmu; ter
(c) the chemical diversity of the active substances, where relevant, or methods and practices of crop management and pest prevention are adequate to minimise the occurrence of resistance in the target organism; and
Člen 50 – odstavek 3 – pododstavek 2
Article 50 – paragraph 3 – subparagraph 2
Takšne registracije se izdajo za največ pet let .
Such authorisations shall be granted for a period not exceeding five years .
Takšne registracije se izdajo za največ tri leta .
Such authorisations shall be granted for a period not exceeding three years.
Vse registracije fitofarmacevtskih sredstev, ki vsebujejo možne snovi za zamenjavo brez primerjalne ocene, je treba omejiti na tri leta.
Any authorisation of plant protection products containing a candidate for substitution without comparative assessment should be limited to three years maximum.
Ponovno se vloži časovna omejitev iz predloga Komisije.
Reinstatement of the timeline proposed by the Commission.
Člen 50 – odstavek 4 – pododstavek 1
Article 50 – paragraph 4 – subparagraph 1
Za fitofarmacevtska sredstva, ki vsebujejo možno snov za zamenjavo, države članice redno izvajajo primerjalno oceno, določeno v odstavku 1, najpozneje ob podaljšanju ali spremembi registracije .
For plant protection products containing a candidate for substitution Member States shall perform the comparative assessment provided for in paragraph 1 regularly and at the latest at renewal or amendment of the authorisation.
Za fitofarmacevtska sredstva, ki vsebujejo možno snov za zamenjavo, države članice redno izvajajo primerjalno oceno, določeno v odstavku 1, najpozneje štiri leta po registraciji ali po odobritvi podaljšanja registracije .
For plant protection products containing a candidate for substitution Member States shall perform the comparative assessment provided for in paragraph 1 regularly and at the latest four years after authorisation or renewal of the authorisation was granted.
Primerjalno oceno je treba opraviti pred koncem obdobja veljavnosti registracije.
Comparative assessment should be done before the end of the authorisation period.
Člen 50 – odstavek 5
Article 50 – paragraph 5
Če se država članica odloči za preklic ali spremembo registracije v skladu z odstavkom 4, začne zadevni preklic ali sprememba veljati pet let po odločitvi države članice ali na koncu obdobja odobritve možne snovi za zamenjavo, če se to obdobje konča prej.
Where a Member State decides to withdraw or amend an authorisation pursuant to paragraph 4, that withdrawal or amendment shall take effect five years after the decision of the Member State or at the end of the approval period of the candidate for substitution where that period ends earlier.
Če se država članica odloči za preklic ali spremembo registracije v skladu z odstavkom 4, začne zadevni preklic ali sprememba veljati dve leti po odločitvi države članice ali na koncu obdobja odobritve možne snovi za zamenjavo, če se to obdobje konča prej.
Where a Member State decides to withdraw or amend an authorisation pursuant to paragraph 4, that withdrawal or amendment shall take effect two years after the decision of the Member State or at the end of the approval period of the candidate for substitution where that period ends earlier.
Predlagani dveletni rok let bo pospešil postopek, ki zadeva snov za zamenjavo, in bo spodbudil inovacije.
The proposed deadline of two years will speed up the process of substitution and give incentive for innovation.
Ponovna vložitev predloga spremembe 173 s prve obravnave.
Reinstating first reading Amendment 173.
Člen 51 – odstavek 2 a (novo)
Article 51 – paragraph 2 a (new)
Po odobritvi Komisije lahko države članice sprejmejo posebne ukrepe, ki omogočijo lažjo predložitev zahtevkov za razširitev registracije za manjše uporabe in predložitev zahtevkov v zvezi s temi uporabami.
Member States may, after authorisation by the Commission, adopt specific measures to facilitate the submission of applications to extend the authorisation for and the submission of applications relating to minor uses.
Poenostavitev birokratskih postopkov in spodbujanje vpletenih k uporabi fitofarmacevtskih sredstev za manjše uporabe bo razrešilo številne težave v zvezi z določenimi kulturnimi rastlinami.
Simplification of bureaucracy and encouragement of those concerned to employ plant protection products for minor uses will resolve numerous problems in relation to certain crops.
Ugotovljeno je bilo, da imetniki registracij niso naklonjeni razširitvi registracij na manjše uporabe zaradi pomanjkanja gospodarskega interesa za industrijo.
It has been noted that authorisation holders are reluctant to extend authorisations to minor uses owing to the lack of economic interest to industry.
Ponovna vložitev predloga spremembe 175 s prve obravnave.
Reinstating first reading Amendment 175.
Člen 51 – odstavek 4 – pododstavek 1
Article 51 – paragraph 4 - subparagraph 1
Če države članice odobrijo razširitev registracije na manjše uporabe, o tem po potrebi obvestijo imetnika registracije in od njega zahtevajo , da v skladu s tem spremeni oznako.
When Member States grant an extension of authorisation for a minor use, they shall inform if necessary the authorisation holder and request him to change the labelling accordingly.
Če države članice odobrijo razširitev registracije na manjše uporabe, o tem obvestijo imetnika registracije, ki v skladu s tem spremeni oznako.
When Member States grant an extension of authorisation for a minor use, they shall inform the authorisation holder, who shall change the labelling accordingly.
Najboljši način za obveščanje uporabnika je, da se manjše uporabe navedejo na etiketi ter da se jasno navede, da odgovornosti za navedene vzorce uporabe ne nosi proizvajalec.
The best way to inform the user is to indicate minor uses on the label and clearly indicate that liability for the indicated use patterns does not lie with the producer.
Delna ponovna vložitev predloga spremembe 179 iz prve obravnave.
Partially reinstating first reading Amendment 179.
Člen 51 – odstavek 4 a (novo)
Article 51 – paragraph 4 a (new)
Ne glede na kakšen način se v državi članici izda razširitev registracije za manjše uporabe, mora biti jasno razvidno, da gre za razširitev v skladu s členom 49, da bi tako pokazali na drugačen pravni status v primerjavi z registracijo v skladu s členom 4.
Regardless of how an extension of the authorisation for minor uses is granted in a Member State, it must be made clear that this is an extension under Article 49 in order to highlight the different legal status compared to an authorisation under Article 4.
Ponovna vložitev predloga spremembe 177 s prve obravnave.
Reinstating first reading Amendment 177.
Člen 51 – odstavek 6
Article 51 – paragraph 6
Države članice sestavijo in redno posodabljajo seznam manjših uporab.
Member States shall establish and regularly update a list of minor uses.
Ponovna vložitev predloga spremembe 180 s prve obravnave.
Reinstating first reading Amendment 180.
Člen 51 – odstavek 6 a (novo)
Article 51 – paragraph 6 a (new)
Komisija Evropskemu parlamentu in Svetu najpozneje do ...* predloži predlog za ustanovitev evropskega sklada za spodbujanje manjših uporab.
6a., N ot later than ... * , the Commission shall present a proposal to the European Parliament and the Council for the establish ment of a European promotion fund for minor uses.
Iz sklada bo mogoče financirati tudi dodatne preiskave na vsebnost ostankov pri manjših uporabah.
The Fund shall also be entitled to finance additional residue tests for minor uses.
Predlog sledi smernicam odbora ITRE, sklicevanje na evropske davke pa je črtano.
This proposal follows the ITRE line but deletes the reference to European Taxes.
Ponovna vložitev predloga spremembe 276 s prve obravnave.
Reinstating first reading Amendment 276.
Člen 52 – odstavek 3 – točki b in c
Article 52 - paragraph 3 - points b and c
(b) so identična po specifikaciji in vsebini aktivnih snovi, varoval in sinergistov ter po vrsti formulacije; ter
(b) they are identical in specification and content of the active substances, safeners and synergists, and in the type of formulation; and
(b) imajo enako specifikacijo ali specifikacije, ki so bile ocenjene kot enake v skladu s postopkom iz člena 38.
(b) they have either the same specification , or specifications assessed as equivalent under the procedure referred to in Article 38 .
(c) so enaka ali ekvivalentna glede vsebovanih dodatkov in velikosti, materiala ali oblike embalaže v smislu možnega škodljivega vpliva na varnost izdelka za zdravje ljudi ali živali ali za okolje.
(c) they are either the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
Zahteve pri opredeljevanju referenčnih proizvodov so nepotrebno omejevalne.
The requirements to determine identity to the reference products are unnecessarily restrictive.
Delna ponovna vložitev predloga spremembe 286 iz prve obravnave.
Partially reinstating first reading Amendment 286.
Člen 52 – odstavek 3 – pododstavek 1 a (novo)
Article 52 – paragraph 3 – subparagraph 1 a (new)
Fitofarmacevtska sredstva, ki ne izpolnjujejo pogoja iz pododstavka (a), izpolnjujejo pa vse ostale pogoje iz tega odstavka, se štejejo za identična referenčnemu sredstvu, če primerjalna ocena, ki jo opravi laboratorij, ki je uradno priznan v skladu z načeli dobre laboratorijske prakse, in ki jo vlagatelj predloži pristojnemu organu države članice uvoznice, ali primerjalna ocena, ki jo opravi pristojni organ, potrjuje, da je fitofarmacevtsko sredstvo, za katerega se zahteva dovoljenje za uvoz, v bistvu identično referenčnemu sredstvu, in da so izpolnjeni naslednji pogoji:
Plant protection products which do not comply with the condition referred to in subparagraph (a) but which do comply with the all the other conditions referred to in this paragraph shall be deemed to be identical to the reference product if a comparative assessment by a laboratory officially recognised in accordance with the Principles of Good Laboratory Practice, which is submitted to the competent authority of the importing Member State by the applicant, or a comparative assessment by the competent authority, confirms that the plant protection product in respect of which an import permit is requested is, in substance, identical to the reference product and that the following requirements are met:
(a) zahteve iz točk (b) in (c) pododstavka 1,
(a) the requirements of subparagraph 1, points (b) and (c),
(b) fitofarmacevtsko sredstvo, za katerega se zahteva dovoljenje za uvoz, ne vsebuje dodatka, ki ni bil ocenjen,
(b) the plant protection product in respect of which an import permit is requested does not contain a co-formulant which has not been assessed,
(c) ne manjka noben dodatek z bistvenimi funkcijami,
(c) no co-formulant s with essential functions are lacking,
(d) sredstvo nima drugačnih nominalnih koncentracij dodatkov z bistvenimi funkcijami, ki so bolj strupeni ali ekotoksični kot referenčno sredstvo ali manj ugodni z vidika učinkovitosti ali stabilnosti kot tisti v referenčnem sredstvu,
(d) the product does not feature different nominal concentrations of co-formulants with essential functions which are more toxic or ecotoxic than the reference product or are less favourable from the point of view of effectiveness or stability than those of the reference product,
(e) ne manjka noben dodatek, ki služi zaščiti uporabnikov ali tretjih strani.
(e) no co-formulants are absent which serve to protect users or third parties.
Člen 52 – odstavek 10 a (novo)
Article 52 – paragraph 10 a (new)
Organi države članice brez poseganja v člen 63 objavijo informacije o dovoljenjih za vzporedno trgovino.
Without prejudice to Article 63, Member State authorities shall make publicly available information about parallel trade permits.
Svet je uvedel nove določbe glede identičnosti pesticidov, s katerimi se vzporedno trguje.
Council introduced new provisions concerning identicality of parallel traded pesticides.
Zaradi pomislekov v zvezi s preglednostjo bi bilo treba objaviti informacije o dovoljenjih za vzporedno trgovino.
Under transparency considerations, the information about parallel trade permits should be made available.
Člen 54 – odstavek 5
Article 54 – paragraph 5
Podrobna pravila za uporabo tega člena, zlasti največje količine fitofarmacevtskih sredstev, ki se lahko sproščajo med preskusi ali testi, ter najmanjše število podatkov, ki jih je treba predložiti v skladu z odstavkom 2, se lahko sprejmejo v skladu z regulativnim postopkom iz člena 79(3) .
Detailed rules for the application of this Article, in particular the maximum quantities of plant protection products that may be released during experiments or tests and the minimum data to be submitted in accordance with paragraph 2, may be adopted in accordance with the regulatory procedure referred to in Article 79(3) .
Podrobna pravila za uporabo tega člena, zlasti največje količine fitofarmacevtskih sredstev, ki se lahko sproščajo med preskusi ali testi, ter najmanjše število podatkov, ki jih je treba predložiti v skladu z odstavkom 2, se lahko sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 79(4) .
Detailed rules for the application of this Article, in particular the maximum quantities of plant protection products that may be released during experiments or tests and the minimum data to be submitted in accordance with paragraph 2, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4 ) .
Ponovna vložitev predloga spremembe 184 s prve obravnave.
Reinstating first reading Amendment 184.
Člen 56 – odstavek 1 – pododstavek 3
Article 56 – paragraph 1 – subparagraph 3
Zato imetnik registracije zabeleži vse mogoče škodljive reakcije pri ljudeh, živalih in na okolju, povezane z uporabo fitofarmacevtskega sredstva, in poroča o njih.
To this end the authorisation holder shall record and report all suspected adverse reactions in humans , in animals and the environment related to the use of the plant protection product.
Ponovna vložitev predloga spremembe 188 s prve obravnave.
Reinstating first reading Amendment 188.
Člen 56 – odstavek 3 – pododstavek 1
Article 56 – paragraph 3 – subparagraph 1
Brez poseganja v pravico držav članic, da sprejmejo začasne varnostne ukrepe, država članica, ki je prva izdala registracijo v vsaki coni , oceni prejete informacije in obvesti druge države članice, ki sodijo v isto območje, 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 first granted an authorisation within each zone shall evaluate the information received and inform the other Member States, belonging to the same zone, where it decides to withdraw or amend the authorisation under Article 44.