natgillin/translations-raw huggingface dataset:
*Opomba UL: 60 mesecev od datuma začetka veljavnosti te uredbe.
* Note to OJ: 60 months from the date of entry into force of this Regulation.
*Opomba UL: 24 mesecev od datuma začetka veljavnosti te uredbe.
* Note to OJ: 24 months from the date of entry into force of this Regulation.
Ponovna vložitev predloga spremembe 108 s prve obravnave.
Reinstating first reading Amendment 108.
Člen 27 – naslov in odstavka 1 in 2
Article 27 - title and paragraphs 1 and 2
Odobritev dodatkov
Approval of co-formulants
Dodatek se ne odobri za vključitev v fitofarmacevtsko sredstvo , kadar se ugotovi, da:
A co-formulant shall not be accepted for inclusion in a plant protection product where it has been established that:
Dodatek se odobri, kadar se ugotovi, da:
A co-formulant shall be approved where it has been established that:
(a) njegovi ostanki, kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe, škodljivo vplivajo na zdravje ljudi ali živali, podzemno vodo ali okolje; ali
(a) its residues, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment; or
(a) dodatek in njegovi ostanki, kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe, nimajo škodljivih vplivov na zdravje ljudi ali živali, podzemno vodo ali okolje; ter
(a) the co-formulant or its residues, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, do not have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment; and
(b) njegova uporaba, kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe, škodljivo vpliva na zdravje ljudi ali živali ali nesprejemljivo vpliva na rastline, rastlinske proizvode ali okolje.
(b) its use, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, has a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment.
(b) njegova uporaba, kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe, nima škodljivega vpliva na zdravje ljudi ali živali ali nesprejemljivega vpliva na rastline, rastlinske proizvode ali okolje.
(b) its use, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, does not have a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment.
Dodatki, ki niso odobreni za vključitev v fitofarmacevtska sredstva, v skladu z odstavkom 1, se v skladu z regulativnim postopkom s pregledom iz člena 79(4) vključijo v Prilogo III.
Co-formulants which shall not be accepted for inclusion in a plant protection product pursuant to paragraph 1 shall be included in Annex III in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
Dodatki, odobreni v skladu z odstavkom 1, se v skladu z regulativnim postopkom s pregledom iz člena 79(4) vključijo v Prilogo III.
Co-formulants approved pursuant to paragraph 1 shall be included in Annex III in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
Ponovna vložitev predloga spremembe 109 s prve obravnave.
Reinstating first reading Amendment 109.
Člen 27 – odstavek 2 a (novo)
Article 27 – paragraph 2 a (new)
Kadar se v fitofarmacevtskem sredstvu, registriranem na podlagi te uredbe, uporabi dodatek, njegova posebna uporaba v fitofarmacevtskih sredstvih velja za registrirano 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 .
Where a co-formulant is used in a plant protection product authorised under this Regulation, its specific use in plant protection products shall be considered 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 .
Popravljeno v UL L 136, 29.5.2007, str.
Corrected in OJ L 136, 29.5.2007, p.
Treba se je izogniti podvajanju predpisov za dodatke, uporabljene v fitofarmacevtskih sredstvih, v tej uredbi in uredbi REACH.
Co-formulants used in plant protection products should not be subject to double regulation under REACH.
Ponovna vložitev predloga spremembe 110 s prve obravnave.
Reinstating first reading Amendment 110.
Člen 28 – odstavek 2 – točka b
Article 28 – paragraph 2 – point (b)
(b) dajanje v promet in uporaba fitofarmacevtskih sredstev za raziskovalne ali razvojne namene v skladu s členom 54;
(b) placing on the market and use of plant protection products for research or development purposes in accordance with Article 54;
(b) uporaba fitofarmacevtskih sredstev za raziskovalne ali razvojne namene v skladu s členom 54;
(b) use of plant protection products for research or development purposes in accordance with Article 54;
Ponovna vložitev predloga spremembe 111 s prve obravnave.
Reinstating first reading Amendment 111.
Člen 29 – odstavek 1 – točka c
Article 29 – paragraph 1 – point (c)
(c) njegovi dodatki niso vključeni v Prilogo III ;
(c) its co-formulants are not included in Annex III;
(c) njegovi dodatki so odobreni v skladu s členom 27 ;
(c) its co-formulants have been approved under Article 27;
Ponovna vložitev predloga spremembe 113 iz prve obravnave.
Reinstating first reading Amendment 113..
Člen 29 – odstavek 1 – točka c a (novo)
Article 29 – paragraph 1 – point (c a) (new)
Ponovna vložitev predloga spremembe 114 s prve obravnave.
Reinstating first reading Amendment 114.
Člen 29 – odstavek 1 – točka e a (novo)
Article 29 – paragraph 1 – point (e a) (new)
(ea) vsi metaboliti aktivne (aktivnih) snovi, ki so navzoči v fazi uporabe, so bili opredeljeni in so v skladu z enotnimi načeli iz odstavka 6;
(ea) all metabolites of the active substance(s) present in the use-phase have been determined and comply with the criteria of the uniform principles referred to in paragraph 6;
Ponovna vložitev predloga spremembe 115 s prve obravnave.
Reinstating first reading Amendment 115.
Člen 29 – odstavek 1 – točka f
Article 29 – paragraph 1 – point (f)
(f) ostanki, ki nastanejo pri registriranih uporabah in so toksikološko, ekotoksikološko ali okoljsko pomembni, se lahko določijo z ustreznimi splošno razširjenimi metodami;
(f) its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental relevance, can be determined by appropriate methods in general use;
(f) ostanki, ki nastanejo pri registriranih uporabah, se lahko določijo s standardiziranimi splošno razširjenimi metodami , ki se uporabljajo v vseh državah članicah in so dovolj občutljive kar zadeva kakršne koli tehnično zaznavne količine, ki bi lahko bile prisotne v katerem koli okoljskem in biološkem mediju .
(f) its residues, resulting from authorised uses, can be determined by standardised methods in general use in all Member States , which are sufficiently sensitive with respect to any technically detectable levels that could be present in any environmental and biological media .
Vsebnost ostankov se določa z ustaljenimi multirezidualnimi metodami, kot jih uporabljajo referenčni laboratoriji Skupnosti.
The residues shall be detectable with the common multi-residue methods as applied by Community reference laboratories;
To je v skladu s prej predlaganim predlogom spremembe člena 4(2) in spremno obrazložitvijo.
This is in line with the earlier amendment suggested at Article 4, paragraph 2 and the related justification.
Ponovna vložitev predloga spremembe 116 s prve obravnave.
Reinstating first reading Amendment 116.
Člen 29 – odstavek 1 – točka h a (novo)
Article 29 – paragraph 1 – point (h a) (new)
(ha) njegova registracija ni v nasprotju z nacionalnimi načrti, pripravljenimi v skladu z Direktivo 2008/.../ES [o določitvi okvira za ukrepe Skupnosti za dosego trajnostne uporabe pesticidov]*.
(ha) its authorisation does not counteract the national plans developed under Directive 200 8 / ... /EC [establishing a framework for Community action to achieve a sustainable use of pesticides] * .
*Opomba UL: vstaviti številko.
* Note to OJ: please insert number.
Ponovna vložitev predloga spremembe 117 s prve obravnave.
Reinstating first reading Amendment 117.
Glede na odstavek 1(e) se lahko sprejmejo usklajene metode v skladu z regulativnim postopkom iz člena 79(3) .
With respect to point (e) of paragraph 1, harmonised methods may be adopted in accordance with the regulatory procedure referred to in Article 79(3).
Glede na odstavek 1(e) se lahko sprejmejo usklajene metode v skladu z regulativnim postopkom s pregledom iz člena 79(4) .
With respect to point (e) of paragraph 1, harmonised methods may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7 9 ( 4 ) .
Ponovna vložitev predloga spremembe 119 s prve obravnave.
Reinstating first reading Amendment 119.
Člen 29 – odstavek 6 – pododstavek 1 a (novo)
Article 29 – paragraph 6 – subparagraph 1 a (new)
Enotna načela dosledno upoštevajo interakcijo med aktivno snovjo, varovali, sinergisti in dodatki.
The uniform principles shall take due account of the interaction between the active substance, safeners, synergists and co-formulants.
Ponovna vložitev predloga spremembe 121 s prve obravnave.
Reinstating first reading Amendment 121.
Člen 30 – odstavek 1 – točka a
Article 30 - paragraph 1 – point a
(a) ni mogoče končati postopkov za sprejem sklepa o odobritvi v roku 30 mesecev od datuma sprejemljivosti vloge, podaljšanega za vsako nadaljnje obdobje, določeno v skladu s členom 9(2), členom 11(3) ali členom 12(3) ; ter
(a) the decision on approval could not be finalised within a time period of 30 months from the date of admissibility of the application, extended with any additional time period set in accordance with Article 9(2), Article 11(3) or Article 12(3); and
(a) ni mogoče končati postopkov za sprejem sklepa o odobritvi v roku 30 mesecev od datuma sprejemljivosti vloge, podaljšanega za vsako nadaljnje obdobje, določeno v skladu s členom 92(2), členom 11(3) ali členom 12(2) ali (3) ; ter
(a) the decision on approval could not be finalised within a time period of 30 months from the date of admissibility of the application, extended with any additional time period set in accordance with Article 92 (2), Article 11 (3) or Article 12 (2) or (3); and
V takih primerih država članica drugim državam članicam in Komisiji takoj sporoči svojo oceno o dokumentaciji in pogojih registracije ter pri tem navede najmanj podatke, določene v členu 57(1).
In such cases the Member State shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the authorisation, giving at least the information provided for in Article 57 (1).
V takih primerih država članica lahko začne ocenjevanje v zvezi s začasno registracijo takoj, ko postane jasno, da roki za registracijo snovi ne bodo izpolnjeni, ter drugim državam članicam in Komisiji takoj sporoči svojo oceno o dokumentaciji in pogojih registracije ter pri tem navede najmanj podatke, določene v členu 57(1).
In such cases the Member State may start its evaluation regarding a provisional authorisation as soon as there is evidence that the deadlines for the substance authorisation will not be met and shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the authorisation, giving at least the information provided for in Article 57 (1).
Svet je spremenil besedilo, kakor ga je sprejel Parlament v prvi obravnavi, in uvedel nov člen v zvezi z začasno registracijo sredstev.
Council has modified the text as adopted by Parliament in 1st reading and has introduced a new article regarding the provisional authorisation of products.
Nov člen je treba spremeniti, da bo odražal predlagane spremembe Evropskega parlamenta iz prve obravnave.
This new article needs to be modified to reflect the proposed changes of the European Parliament in 1st reading.
Člen 31 – odstavek 2 – pododstavek 1 a (novo)
Article 31 – paragraph 2 – subparagraph 1 a (new)
Te zahteve prav tako vključujejo:
These requirements shall also include:
(a) najvišji odmerek na hektar v vsakem nanašanju;
(a) the maximum dose per hectare in each application;
(b) obdobje med zadnjim nanašanjem in spravilom pridelka;
(b) the period between the last application and harvest;
(c) število nanašanj na leto.
(c) the number of applications per year.
Te informacije bi moralo biti obvezno navesti za vsako registracijo.
It should be compulsory to indicate the information above in every authorisation.
Ponovna vložitev predloga spremembe 124 s prve obravnave.
Reinstating first reading Amendment 124.
Člen 31 – odstavek 2 – pododstavek 2
Article 31 –paragraph 2 – subparagraph 2
Registracija vključuje razvrstitev fitofarmacevtskega sredstva za namen Direktive 1999/45/ES.
The authorisation shall include a classification of the plant protection product for the purpose of Directive 1999/45/EC.
Države članice lahko določijo, da imetniki registracij brez neupravičene zamude razvrstijo ali posodobijo oznako zaradi spremembe v razvrščanju ali označevanju fitofarmacevtskega sredstva v skladu z Direktivo 1999/45/ES.
Member States may provide that authorisation holders shall classify or update the label without undue delay following any change to the classification and labelling of the plant protection product in accordance with Directive 1999/45/EC.
V takšnih primerih o tem nemudoma obvestijo pristojni organ.
In such case, they shall immediately inform the competent authority thereof.
Države članice določijo, da imetniki registracij brez neupravičene zamude razvrstijo ali posodobijo oznako zaradi spremembe v razvrščanju ali označevanju fitofarmacevtskega sredstva v skladu z Direktivo 1999/45/ES.
Member States shall provide that authorisation holders shall classify or update the label without undue delay following any change to the classification and labelling of the plant protection product in accordance with Directive 1999/45/EC.
Za države članice mora biti zavezujoče, da zagotovijo, da imetniki registracij posodobijo oznako.
It should be obligatory on Member States to make provisions that authorisation holders update the label.
Predlog spremembe k novemu besedilu, ki ga je predlagal Svet.
Amendment of a new passage introduced by Council.
Člen 31 – odstavek 2 – pododstavek 2 a
Article 31 - paragraph 2 - subparagraph 2a
Registracija vključuje navodila za pravilno uporabo v skladu z načeli integriranega varstva rastlin pred škodljivci, kot je opredeljeno v členu 3, od leta 2012 dalje;
The authorisation shall include indications for proper use in accordance with the principles of i ntegrated p est m anagement as defined in Article 3, to apply from 2012 onwards;
Ponovna vložitev predloga spremembe 305 s prve obravnave.
Reinstating first reading Amendment 305.
Člen 31 – odstavek 3 – točka a
Article 31 –paragraph 3 – point (a)
(a) omejitev distribucije in uporabe fitofarmacevtskih sredstev ob upoštevanju zahtev drugih določb zakonodaje Skupnosti , da bi se varovalo zdravje zadevnih distributerjev, uporabnikov, navzočih oseb in delavcev ter okolje; tovrstna omejitev se navede na etiketi;
(a) a restriction with respect to the distribution and use of the plant protection product taking into consideration requirements imposed by other community provisions in order to protect the health of the distributors, users, bystanders and workers concerned and the environment; such restriction shall be indicated on the label;
(a) omejitev distribucije in uporabe fitofarmacevtskih sredstev, da bi se varovalo zdravje zadevnih distributerjev, uporabnikov, navzočih oseb , prebivalcev in delavcev ter okolje ob upoštevanju zahtev iz drugih določb Skupnosti ; tovrstna omejitev se navede na etiketi;
(a) a restriction with respect to the distribution and use of the plant protection product in order to protect the health of the distributors, users, bystanders, residents and workers concerned and consumers or animal health or the environment, taking into consideration requirements imposed by other C ommunity provisions ; such restriction shall be indicated on the label;
Ponovna vložitev predloga spremembe 303 iz prve obravnave in popravek novega besedila Sveta, da bi se dodatne določbe Skupnosti omenile kot dodatek in ne kot omejitev.
Reinstatement of amendment 303 from first reading, and rearrangement of new Council text to address other community provisions as an addition and not as a limitation .
Ponovna vložitev predloga spremembe 126 s prve obravnave.
Reinstating first reading Amendment 126.
Člen 31 – odstavek 3 – točka b a (novo)
Article 31 – paragraph 3 – point (b a) (new)
(ba) kakršne koli omejitve ali prepovedi uporabe pesticidov na območjih, ki jih uporablja širša javnost ali ranljive skupine, kot so stanovanjska naselja, parki, javni vrtovi, športna, šolska, otroška igrišča, in v okolici teh območij;
(ba) any restrictions or prohibitions of pesticide use in and around areas used by the general public or by vulnerable groups, s uch as residential areas, parks, public gardens, sports grounds, school grounds, children’s playgrounds ;
Ponovna vložitev predloga spremembe 127 iz prve obravnave.
Reinstating first reading amendment 127.
Člen 31 – odstavek 3 – točka b b (novo)
Article 31 – paragraph 3 – point (b b) (new)
(bb) druge omejitve ali pogoje, povezane z odobritvijo in uporabo fitofarmacevtskih sredstev, zlasti ko so ti namenjeni za zaščito zdravja distributerjev, uporabnikov, delavcev, prebivalcev, drugih prisotnih oseb in potrošnikov, za zaščito zdravja živali ali okolja;
(bb) other restrictions or conditions relevant to the issue of an authorisation and to the use of the plant protection product, particularly where these are intended to protect the health of distributors, users, workers, residents, bystanders and consumers or animal health or the environment;
Ta nova točka bi državam članicam omogočila vključitev drugih omejitev ali pogojev, zlasti za zaščito distributerjev, uporabnikov, delavcev, prebivalcev, navzočih oseb in potrošnikov, ali zdravja živali ali okolja.
This new point would enable Member States to include other restrictions or conditions, particularly for the protection of distributors, users, workers, residents, bystanders and consumers, or animal health or the environment.
(Ponovna vložitev predloga spremembe 303 iz prve obravnave.)
Reinstatement of am 303 of first reading.
Člen 31 – odstavek 3 – točka e
Article 31 – paragraph 3 – point (e)
(e) najvišji odmerek na hektar v vsakem nanašanju;
(e) the maximum dose per hectare in each application;
Ta predlog spremembe je povezan s predlogom spremembe člena 31(2)(1a) poročevalca.
This amendment is linked to the amendment to Article 31, paragraph 2, subparagraph 1a by the rapporteur.
Ta predlog spremembe je brezpredmeten, če navedeni predlog spremembe ne bo sprejet.
This amendment should fall in case that amendment is not adopted.
V skladu s ponovno vložitvijo predloga spremembe 124 iz prve obravnave.
In line with the reinstatement of first reading Amendment 124.
Člen 31 – odstavek 3 – točka f
Article 31 – paragraph 3 – point (f)
(f) največje število nanašanj na leto in obdobje med nanašanji;
(f) the maximum number of applications per year and interval between applications;
Člen 31 – odstavek 3 – točka h
Article 31 – paragraph 3 – point (h)
(h) karenco, kjer je primerno;
(h) the pre-harvest interval, where applicable;
Člen 33 – odstavek 2 – točki a in b
Article 33 – paragraph 2 – point (a) and (b)
(a) seznam predvidene uporabe v vsaki coni, kakor je navedeno v Prilogi I, in v državah članicah , kjer je vlagatelj predložil zahtevek ali ga namerava predložiti;
(a) a list of intended uses in each zone as indicated in Annex I and the Member States where the applicant has made or intends to make an application;
(a) seznam predvidene uporabe in držav članic , kjer je vlagatelj predložil zahtevek ali ga namerava predložiti;
(a) a list of intended uses and the Member States where the applicant has made or intends to make an application;
V tem primeru vlagatelj drugim državam članicam na zahtevo pošlje popolno dokumentacijo ali njen povzetek iz člena 8;
In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request;
Člen 33 – odstavek 3 – točka b
Article 33 – paragraph 3 – point b
(b) za vsako aktivno snov, varovalo in sinergist v fitofarmacevtskem sredstvu popolna dokumentacija in njen povzetek za vsako točko zahtev po podatkih o aktivni snovi, varovalu in sinergistu;
(b) for each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist;
(b) za vsako aktivno snov, varovalo , sinergist , dodatek in pomožno snov v fitofarmacevtskem sredstvu popolna dokumentacija in njen povzetek za vsako točko zahtev po podatkih o aktivni snovi, varovalu , sinergistu , dodatku in pomožni snovi, prav tako popolna dokumentacija in njen povzetek o skupnih učinkih aktivne (aktivnih) snovi, varovala (varoval), sinergista (sinergistov), dodatka (dodatkov) in pomožne (pomožnih) snovi v fitofarmacevtskem sredstvu ;
(b) for each active substance, safener and synergist, co-formulant and adjuvant contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist, co-formulant and adjuvant , as well as a complete and a summary dossier on the combined effect of the active substance(s), safener(s) and synergist(s), co-formulant(s) and adjuvant(s) contained in the plant protection product ;
Jasno je, da se varovala, sinergisti, dodatki in pomožne snovi dodajajo zato, da se izboljša ali spremeni učinek aktivne snovi, kar pomeni, da se zaradi tega njihov skupni učinek razlikuje od učinka posamezne snovi.
Clearly safeners, synergists, co-formulants and adjuvants are added to enhance or modify the effect of the active substance, making the combined effect different from the added-on effect of the individual substances.
Ponovna vložitev predloga spremembe 129 s prve obravnave.
Reinstating first reading Amendment 129.
Člen 33 – odstavek 3 – točka c
Article 33 – paragraph 3 – point c
(c) za vsak preskus ali študijo, ki vključuje vretenčarje, utemeljitev ukrepov, sprejetih za preprečitev nepotrebnih preskusov;
(c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid unnecessary testing;
(c) za vsak preskus ali študijo, ki vključuje vretenčarje, utemeljitev ukrepov, sprejetih za preprečitev preskusov na živalih in podvajanja preskusov na vretenčarjih ;
(c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplicative testing on vertebrate animals ;
Ponovna vložitev predloga spremembe 130 s prve obravnave.
Reinstating first reading Amendment 130.
Člen 33 – odstavek 6 a (novo)
Article 33 – paragraph 6 a (new)
Člen 33 – odstavek 6 b (novo)
Article 33 – paragraph 6 b (new)
Ponovna vložitev predloga spremembe 133 s prve obravnave.
Reinstating first reading Amendment 133.
Vlogo preuči država članica, ki jo je predlagal vlagatelj, razen če jo želi preučiti druga država članica iz iste cone .
The application shall be examined by the Member State proposed by the applicant , unless another Member State in the same zone agrees to examine it.
Država članica, ki bo preučila vlogo, o tem obvesti vlagatelja.
The Member State which will examine the application shall inform the applicant.
Vlogo preuči država članica, ki jo je predlagal vlagatelj, razen če s preučitvijo soglaša druga država članica.
The application shall be examined by the Member State proposed by the applicant , unless another Member State agrees to examine it.