natgillin/translations-raw huggingface dataset:
Ponovna vložitev predloga spremembe 255 iz prve obravnave.
Reinstating amendment 255 of first reading .
Člen 4 – odstavek 3 – točka b
Article 4 – paragraph 3 – point (b)
(b) nima takojšnjega ali zapoznelega škodljivega vpliva na zdravje ljudi ali živali neposredno ali prek pitne vode (ob upoštevanju snovi, nastalih pri obdelavi pitne vode), hrane, krme ali zraka ali posledic na delovnem mestu ali preko drugih neposrednih vplivov, ob upoštevanju ugotovljenih kumulativnih in sinergijskih vplivov, kadar so metode za ocenjevanje takšnih vplivov dogovorjene ; ali vpliva na podzemno vodo;
(b) it shall have no immediate or delayed harmful effect on human or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the methods to assess such effects are agreed; or on groundwater;
(b) nima takojšnjega ali zapoznelega škodljivega vpliva na zdravje ljudi , zlasti zdravje prebivalcev, navzočih oseb in ranljivih skupin, ali na zdravje živali neposredno ali prek pitne vode (ob upoštevanju snovi, nastalih pri obdelavi pitne vode), hrane, krme ali zraka , vključno z lokacijami, oddaljenimi od kraja uporabe snovi zaradi prenosu na velike razdalje, ali posledic na delovnem mestu ali preko drugih neposrednih vplivov, ob upoštevanju ugotovljenih kumulativnih in sinergijskih vplivov, kadar so metode za ocenjevanje takšnih vplivov na voljo ; ali vpliva na površinsko in podzemno vodo;
(b) it shall have no immediate or delayed harmful effect on human health, in particular that of residents and bystanders and vulnerable groups , or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, i ncluding in locations distant from its use following long-range transportation, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects , where the methods to assess such effects are available; or on surface water or groundwater;
Zaščititi je treba vse podskupine prebivalstva, ki so lahko izpostavljene pesticidom, vključno s prebivalci, ki so lahko redno izpostavljeni pesticidom iz različnih virov.
All the various subgroups at risk of exposure to pesticides must be protected, including residents, who can be regularly exposed to pesticides from various sources.
Pogosto traja zelo dolgo, preden pride do dogovora o metodah.
It often takes very long to agree on methods.
Če so na voljo metode za oceno kumulativnih in sinergijskih učinkov, bi jih bilo treba uporabiti.
If methods are available to assess cumulative and synergistic effects, they should be used.
Ponovna vložitev predloga spremembe 297 iz prve obravnave in besedila iz predloga Komisije.
Reinstatement of am 297 of first reading and of text from the Commission proposal.
Člen 4 – odstavek 3 – točka (e)
Article 4 – paragraph 3 – point (e)
(i) usode in obnašanja teh sredstev v okolju, zlasti onesnaženja površinskih voda, rečnih ustij in obalnih vod, podzemne vode, zraka in tal;
(i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, groundwater, air and soil;
(i) usode in obnašanja teh sredstev v okolju, zlasti onesnaženja površinskih voda, rečnih ustij in obalnih vod, pitne in podzemne vode, zraka in tal, ob upoštevanju lokacij, oddaljenih od kraja uporabe snovi, po prenosu v okolju na velike razdalje ;
(i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, drinking water, groundwater, air and soil, taking into account locations distant from its use following long-range environmental transportation ;
Povsod po Evropi najdemo habitate vrst na robu izumrtja, ki so navedene na rdečem seznamu.
Habitats of species threatened with extinction which appear on the Red List are to be found in many parts of Europe.
Pesticidi in fitofarmacevtska sredstva ogrožajo zlasti ptice, saj se selijo in prehranjujejo na različnih območjih, kjer lahko poteka škropljenje ali drugo obdelovanje s pesticidi ter drugimi snovmi.
Pesticides and other plant protection products are a threat to birds in particular, given that they migrate and feed in many different areas where spraying and other treatments involving pesticides, among other substances, may take place.
Ponovna vložitev predloga spremembe 64 s prve obravnave.
Reinstating first reading Amendment 64.
Člen 4 – odstavek 7
Article 4 –paragraph 7
Z odstopanjem od odstavka 1 ter če je na podlagi dokumentiranih dokazov aktivna snov potrebna za nadzor resne nevarnosti za zdravje rastlin, ki je ni mogoče obvladati na drugačen način , se takšna aktivna snov lahko odobri za omejeno obdobje, ki ni daljše od petih let, čeprav ne izpolnjuje meril iz točk 3.6.3, 3.6.4, 3.6.5 ali 3.8.2 Priloge II, če za uporabo aktivne snovi veljajo ukrepi za zmanjšanje tveganja, ki zagotovijo najmanjšo možno izpostavljenost človeka in okolja.
By way of derogation from paragraph 1, where on the basis of documented evidence an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means, such active substance may be approved for a time limited period not exceeding five years even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised.
Za te snovi se mejne vrednosti ostankov določijo v skladu z Uredbo (ES) št. 396/2005.
For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005.
Z odstopanjem od odstavka 1 , če:
By way of derogation from paragraph 1, where:
(a) vlagatelj na podlagi dokumentiranih dokazov dokaže, da je aktivna snov potrebna za nadzor resne nevarnosti za zdravje rastlin v državi članici , ki je ni mogoče obvladati na drugačen način , vključno z nekemičnimi sredstvi; ter
a) it is proven by the applicant on the basis of documented evidence that an active substance is necessary to control a serious danger to plant health in a Member State which cannot be contained by other available means, including non-chemical means ; and
(b) je v javnem interesu, da se ta nevarnost nadzira,
b) there is a public interest in controlling that danger,
se takšna aktivna snov lahko odobri za omejeno obdobje, ki je potrebno za nadzor te resne nevarnosti, vendar v tej državi članici ni daljše od štirih let, čeprav ne izpolnjuje meril iz točk 3.6.3, 3.6.4, 3.6.5 ali 3.8.2 Priloge II, če za uporabo aktivne snovi veljajo ukrepi za zmanjšanje tveganja, ki zagotovijo najmanjšo možno izpostavljenost človeka in okolja , ter če vlagatelj predstavi načrt nadomestitve, ki vsebuje načine nadzora resne nevarnosti v dveh letih z uporabo drugih sredstev,vključno z nekemičnimi metodami .
such active substance may be approved for a time-limited period necessary to control that serious danger but not exceeding four years in that Member State even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised , and that a substitution plan on how to control the serious danger in two years' time by other means, including non-chemical methods, is presented by the applicant .
Odstopanje se ne uporablja za aktivne snovi, ki so ali morajo biti razvrščene v skladu z Direktivo 67/548/EGS kot rakotvorne iz kategorije 1 ali strupene za razmnoževanje iz kategorije 1.
This derogation shall not apply to active substances which are or have to be classified in accordance with Directive 67/548/EEC, as carcinogenic category 1 or toxic for reproduction category 1.
Odstopanje se ne uporablja za aktivne snovi, ki so ali morajo biti razvrščene v skladu z Direktivo 67/548/EGS kot rakotvorne iz kategorije 1 , rakotvorne iz kategorije 2 brez mejne vrednosti ali strupene za razmnoževanje iz kategorije 1.
This derogation shall not apply to active substances which are or have to be classified in accordance with Directive 67/548/EEC, as carcinogenic category 1, carcinogenic category 2 without a threshold, or toxic for reproduction category 1.
Če vlagatelj zaprosi za odstopanje na podlagi tega odstavka, se časovne omejitve iz členov 12 in 13 prepolovijo.
If an applicant applies for a derogation under this paragraph, the timelines set out in Article s 12 and 13 shall be halved.
Da se preprečijo preskusi na živalih, se preskuse na vretenčarjih za namene te uredbe izvaja samo kot skrajni ukrep.
In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort.
Spodbujajo se preskusi brez uporabe živali in inteligentne strategije preskusov, prepovejo pa se podvojeni preskusi na vretenčarjih.
The use of non-animal tests and intelligent testing strategies shall be promoted, and duplicate vertebrate animal testing shall be prohibited.
S spodbujanjem inteligentnih strategij preskusov in obvezne izmenjave podatkov se število uporabljenih živali lahko precej zniža.
The promotion of intelligent testing strategies and compulsory data sharing can significantly reduce the number of animals used.
Člen 6 – točka i a (novo)
Article 6 – point (ia) (new)
Ponovna vložitev predloga spremembe 68 s prve obravnave.
Reinstating first reading Amendment 68.
Proizvajalec aktivne snovi predloži državi članici, v nadaljnjem besedilu "država članica poročevalka", zahtevek za odobritev aktivne snovi ali za spremembo pogojev za odobritev skupaj s povzetkom in popolno dokumentacijo, kakor je določeno v členu 8(1) in (2), ali na podlagi znanstvene obrazložitve utemelji, zakaj nekaterih delov te dokumentacije ne more predložiti, ter dokaže, da aktivna snov izpolnjuje merila za odobritev iz člena 4.
An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State, hereinafter referred to as "rapporteur Member State", together with a summary and a complete dossier as provided for in Article 8(1) and (2) or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4.
Proizvajalec aktivne snovi predloži Agenciji zahtevek za odobritev aktivne snovi ali za spremembo pogojev za odobritev skupaj s popolno dokumentacijo in njenim povzetkom , kakor je določeno v členu 8(1) in (2), ali izjavo o dostopnosti takšne dokumentacije ali na podlagi znanstvene obrazložitve utemelji, zakaj nekaterih delov te dokumentacije ne more predložiti, ter dokaže, da aktivna snov izpolnjuje merila za odobritev iz člena 4.
An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to the Authority together with a complete and a summary dossier, as provided for in Article 8(1) and (2), or a letter of access to such dossiers or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4.
Združenje proizvajalcev, ki ga imenujejo proizvajalci za zagotovitev skladnosti s to uredbo, lahko predloži skupni zahtevek.
A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.
Država članica lahko izbere aktivno snov, za katero je Agencija prejela zahtevek za odobritev, da tako postane država članica poročevalka.
A Member State may choose an active substance for which an application for approval has been received by the Authority, with the aim of becoming the rapporteur Member State .
Zahtevek 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.
Če dve ali več držav članic izrazi zanimanje za vlogo države članice poročevalke in se ne morejo dogovoriti, katera bo prevzela to pristojnost, se država članica poročevalka določi v skladu z regulativnim postopkom iz člena 79(3).
In cases where two or more Member States have expressed an interest in becoming the rapporteur Member State and they cannot agree who should be the competent authority, the rapporteur Member State shall be determined in accordance with the regulatory procedure referred to in Article 79 (3).
Odločitev temelji na objektivnih merilih, kot so geografski, kmetijski in podnebni pogoji, zlasti glede ciljnih organizmov, izvajanja ter nepristranskosti pristojnega organa in referenčnega laboratorija ter odsotnosti interesov, povezanih s proizvodnimi podjetji.
The decision shall be based on objective criteria such as geographic, agricultural and climatic conditions, especially with regard to the target organisms, the performance and impartiality of the competent authority and the reference laboratory, and the absence of interests linked to the producing companies.
Ponovna vložitev predloga spremembe 69 s prve obravnave.
Reinstating first reading Amendment 69.
Predlog spremembe si prizadeva za vzpostavitev enakih konkurenčnih pogojev za vse proizvajalce, tudi za tiste, ki imajo sedež zunaj Skupnosti.
The amendment seeks to establish a level playing field for all producers, including the ones established in a jurisdiction outside the Community.
Ponovna vložitev predloga spremembe 70 iz prve obravnave.
Reinstating first reading AM 70.
Člen 7 – odstavek 1 b (novo)
Article 7 – paragraph 1 b (new)
Zahtevek lahko oceni več držav članic skupaj na podlagi sistema skupnega poročanja.
Assessment of an application may be performed by a number of Member States together under the co-rapporteur system.
Enaka določba se uporablja tudi pri ocenah v skladu z Direktivo 91/414/EGS in pomembno vpliva na hitrost in kakovost poročil o oceni aktivnih snovi.
The same provision applies to assessments under Directive 91/414/EEC and has a considerable influence on the speed and quality of the assessment reports on active substances.
Ponovna vložitev predloga spremembe 71 iz prve obravnave.
Reinstating frist reading Amendment 71
Člen 8 – odstavek 1 – točka c a (novo)
Article 8 – paragraph 1 – point c a (new)
(ca) za vsak preskus ali študijo, ki vključuje vretenčarje, utemeljitev ukrepov, sprejetih za preprečitev preskusov na živalih in podvajanja preskusov na vretenčarjih;
(ca) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplicative testing on vertebrate animals;
Da bi preskuse na živalih za namene te uredbe čim bolj omejili, morajo zahtevki vsebovati tudi obrazložitev ukrepov, ki jih je prosilec uvedel, da bi omejil preskuse na živalih.
In order to facilitate that animal testing for the purposes of this Regulation is kept to an absolute minimum, applications should also be required to provide a justification of the steps taken to avoid animal testing in general.
Ponovna vložitev predloga spremembe 75 iz prve obravnave.
Reinstatement of first reading Amendment 75.
To bo koristilo nepričakovanim učinkom pri čebelah, ki jih ocena tveganja ne zazna, so pa vsestransko dokumentirani v znanstveni literaturi.
This will benefit unexpected effects in bees that are not detected in the risk assessment but are widely documented in the scientific literature.
Ponovna vložitev predloga spremembe 78 s prve obravnave.
Reinstating first reading Amendment 78.
V dvanajstih mesecih po datumu uradnega obvestila iz prvega pododstavka člena 9(3) država članica poročevalka pripravi in Komisiji – s kopijo Agenciji – predloži poročilo , v nadaljnjem besedilu: " osnutek poročila o oceni " , v katerem oceni, ali je verjetno, da bo aktivna snov izpolnila merila za odobritev iz člena 4.
Within twelve months of the date of the notification provided for in the first subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit to the Commission, with a copy to the Authority a report , hereinafter referred to as "draft assessment report", assessing whether the active substance can be expected to meet the approval criteria provided for in Article 4.
Država članica poročevalka lahko začne z ocenjevanjem poročil o preskusih in študijah, takoj ko jih predloži vlagatelj, med drugim tudi pred datumom uradnega obvestila iz prvega pododstavka člena 9(3).
The rapporteur Member State may start the evaluation of test and study reports as soon as they are submitted by the applicant, including before the date of the notification provided for in the first subparagraph of Article 9(3).
V dvanajstih mesecih po datumu uradnega obvestila iz prvega pododstavka člena 9(3) država članica poročevalka pripravi in Komisiji – s kopijo Agenciji – predloži poročilo ( v nadaljnjem besedilu: „ osnutek poročila o oceni “ ) , v katerem oceni, ali je verjetno, da bo aktivna snov izpolnila merila za odobritev iz člena 4.
Within twelve months of the date of the notification provided for in the first subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit to the Commission, with a copy to the Authority, a report ( hereinafter referred to as “draft assessment report” ) assessing whether the active substance can be expected to meet the approval criteria provided for in Article 4.
Delna ponovna vložitev predloga spremembe 80 iz prve obravnave.
Partially reinstating first reading Amendment 80.
Člen 11 – odstavek 2 – pododstavek 1
Article 11 – paragraph 2 - subparagraph 1
Osnutek poročila o oceni, kjer je to ustrezno, vključuje tudi predlog za določitev mejne vrednosti ostankov.
The draft assessment report shall also include where relevant, a proposal to set maximum residue levels.
V takem primeru država članica poročevalka pošlje Komisiji zahtevek, ocenjevalno poročilo in spremljevalni dosje iz člena 9 Uredbe (ES) št. 396/2005 najpozneje šest mesecev od datuma uradnega obvestila, določenega v prvem pododstavku člena 9(3) te uredbe.
In such a case the rapporteur Member State shall forward the application, the evaluation report and the supporting dossier referred to in Article 9 of Regulation (EC) No 396/2005 to the Commission no later than six months after the date of the notification provided for in the first subparagraph of Article 9(3) of this Regulation.
Osnutek poročila o oceni, kjer je to ustrezno, vključuje tudi predlog za določitev mejne vrednosti ostankov.
The draft assessment report shall also include, where relevant, a proposal to set maximum residue levels.
Pojasnilo, ki je potrebno v zvezi z določanjem mejne vrednosti, če Agencija sklepov ne sprejme v predpisanem roku.
Necessary clarification on the setting of the MRL if the conclusions of the Authority are not adopted within the prescribed time limit.
Člen 12 – odstavek 2 – pododstavek 2
Article 12 – paragraph 2 - subparagraph 2
Agencija v 120 dneh od konca obdobja za predložitev pisnih pripomb, glede na trenutna znanstvena in tehnična spoznanja, ob uporabi smernic, ki so na voljo v času predložitve vloge, sprejme sklep o tem, ali se pričakuje, da bo aktivna snov izpolnila merila za odobritev iz člena 4, in o tem obvesti vlagatelja, države članice in Komisijo ter sklep da na voljo javnosti.
Within 120 days of the end of the period provided for the submission of written comments, the Authority shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents available at the time of application on whether the active substance can be expected to meet the approval criteria provided for in Article 4 and shall communicate it to the applicant, the Member States and the Commission and shall make it available to the public.
Če se organizira posvetovanje iz prvega pododstavka, se 120-dnevno obdobje podaljša za 60 dni.
Where a consultation as provided for in the first subparagraph is organised, the 120-day period shall be extended by 60 days.
Agenciji je treba za pripravo sklepa dati dovolj časa.
The Authority needs to be given enough time to prepare its conclusion.
V skladu s sedanjimi zahtevami ima EFSA na voljo šest mesecev.
Current requirements grant six months to EFSA.
Dosedanje izkušnje kažejo, da je šestmesečno obdobje odločilnega pomena za pripravo učinkovitega in znanstveno zanesljivega medsebojnega pregleda.
Experience so far has shown that a period of six months is critical to conduct an effective and scientifically robust peer review.
Pri 120-dnevnem obdobju npr. ne bi bilo mogoče organizirati sestanka strokovnjakov.
A 120-day period would for example not allow organising an expert meeting.
Tako bi bilo treba v primeru, ko je potrebno posvetovanje strokovnjakov, obdobje podaljšati za 60 dni.
As such, when a consultation of experts is required, the period should be extended by 60 days.
Sporazumni predlog spremembe, ki temelji na predlogu spremembe 83 iz prve obravnave.
Compromise suggestion based on first reading Amendment 83.
Če Agencija sprejme sklep v roku, določenem v odstavku 2 tega člena in podaljšanem za dodatno obdobje, določeno v odstavku 3, se določbe člena 11 Uredbe (ES) št. 396/2005 ne uporabljajo in se nemudoma začnejo uporabljati določbe člena 14 omenjene uredbe.
Where the conclusion of the Authority is adopted within the time limit set out in paragraph 2 of this Article, extended by any additional time period set in paragraph 3, the provisions of Article 11 of Regulation (EC) No 396/2005 shall not apply and the provisions of Article 14 of that Regulation shall apply without delay.
Pojasnilo, ki je potrebno v zvezi z določanjem mejne vrednosti, saj tega ni mogoče opraviti preden Agencija ne sprejme sklepov.
Necessary clarification, the setting of the MRL can not take place before the conclusions of the Authority
Člen 12 – odstavek 6 b (novo)
Article 12 – paragraph 6 b (new)
Če Agencija sklepa ne sprejme v roku, določenem v odstavku 2 tega člena in podaljšanem za dodatno obdobje, določeno v odstavku 3, se nemudoma začnejo uporabljati določbe členov 11 in 14 Uredbe (ES) št. 396/2005.
Where the conclusion of the Authority is not adopted within the time limit set out in paragraph 2 of this Article, extended by any additional time period set in paragraph 3, the provisions of Articles 11 and 14 of Regulation (EC) No 396/2005 shall apply without delay.
V šestih mesecih po prejemu sklepa Agencije Komisija Odboru iz člena 79(1) predloži poročilo , v nadaljnjem besedilu: " poročilo o pregledu " , in osnutek uredbe, ob upoštevanju osnutka poročila o oceni, ki ga oblikuje država članica poročevalka, in sklepa Agencije.
Within six months of receiving the conclusion from the Authority, the Commission shall present a report, hereinafter referred to as "the review report", and a draft Regulation to the Committee referred to in Article 79(1), taking into account the draft assessment report by the rapporteur Member State and the conclusion of the Authority.
V treh mesecih po prejemu sklepa Agencije Komisija Odboru iz člena 79(1) predloži poročilo ( v nadaljnjem besedilu: „ poročilo o pregledu “ ) , in osnutek uredbe, ob upoštevanju osnutka poročila o oceni, ki ga oblikuje država članica poročevalka, in sklepa Agencije.
Within three months of receiving the conclusion from the Authority, the Commission shall present a report, ( hereinafter referred to as “the review report" ) , and a draft Regulation to the Committee referred to in Article 79(1), taking into account the draft assessment report by the rapporteur Member State and the conclusion of the Authority.
Ponovna vložitev predloga spremembe 86 s prve obravnave.
Reinstating first reading Amendment 86.
Člen 13 – odstavek 2 – uvod in točka a
Article 13 – paragraph 2 – introduction and point (a)