natgillin/translations-raw huggingface dataset:
‘biodiversity’ means variability among living organisms from all sources, including terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this variability may include diversity within species, between species and of ecosystems;
„biotska raznovrstnost“ je raznolikost med živimi organizmi iz vseh virov, vključno s kopenskimi, morskimi in drugimi vodnimi ekosistemi in ekološkimi kompleksi, katerih del so; to vključuje raznovrstnost znotraj vrst, med vrstami in ekosistemi;
‘competent authority’ means any authority or authorities of a Member State responsible for carrying out the tasks established under this Regulation;
„pristojni organ“ je vsak organ ali organi držav članic, ki so pristojni za izvajanje nalog, določenih s to uredbo;
‘advertisement’ means a means of promoting the sale or use of plant protection products (to anyone other than the authorisation holder, the person placing the plant protection product on the market and their agents) by printed or electronic media;
„oglaševanje“ je sredstvo za spodbujanje prodaje ali uporabe fitofarmacevtskih sredstev (vsem, razen imetniku registracije, osebi, ki daje fitofarmacevtsko sredstvo v promet, in njunim zastopnikom) s tiskanimi ali elektronskimi mediji;
‘metabolite’ means any metabolite or a degradation product of an active substance, safener or synergist, formed either in organisms or in the environment.
„metabolit“ je vsak metabolit ali produkt, ki nastane pri razgradnji aktivne snovi, varovala ali sinergista, v organizmih ali v okolju.
A metabolite is deemed relevant if there is a reason to assume that it has intrinsic properties comparable to the parent substance in terms of its biological target activity, or that it poses a higher or comparable risk to organisms than the parent substance or that it has certain toxicological properties that are considered unacceptable.
Metabolit šteje za relevantnega, če obstaja razlog za domnevo, da ima glede svoje ciljne biološke aktivnosti primerljive bistvene lastnosti kot izhodiščna snov, ali če predstavlja za organizme večje ali primerljivo tveganje kot izhodiščna snov ali če ima določene toksikološke lastnosti, ki veljajo za nesprejemljive.
Such a metabolite is relevant for the overall approval decision or for the definition of risk mitigation measures;
Takšen metabolit je relevanten pri celoviti odločitvi o odobritvi ali pri opredelitvi ukrepov za zmanjšanje tveganja;
‘impurity’ means any component other than the pure active substance and/or variant which is present in the technical material (including components originating from the manufacturing process or from degradation during storage).
„nečistoče“ so kakršne koli druge sestavine, ki niso čista aktivna snov in/ali varianta in ki jih vsebuje tehnični material (vključno s sestavinami, ki nastanejo med proizvodnim postopkom ali so posledica razgrajevanja med skladiščenjem).
ACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS
AKTIVNE SNOVI, VAROVALA, SINERGISTI IN DODATKI
Active substances
Aktivne snovi
Requirements and conditions for approval
Zahteve in pogoji za odobritev
Approval criteria for active substances
Merila za odobritev aktivnih snovi
An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3.
Aktivna snov se odobri v skladu s Prilogo II, če se lahko glede na sedanja znanstvena in tehnična spoznanja predvideva, da bodo, ob upoštevanju meril za odobritev, določenih v točkah 2 in 3 navedene priloge, fitofarmacevtska sredstva, ki vsebujejo to aktivno snov, izpolnila pogoje iz odstavkov 2 in 3.
The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied.
V oceni aktivne snovi se najprej ugotovi, ali so izpolnjena merila za odobritev iz točk 3.6.2 do 3.6.4 in 3.7 Priloge II.
If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied.
Če so ta merila izpolnjena, se ocenjevanje nadaljuje in ugotavlja, ali so izpolnjena druga merila iz točk 2 in 3 Priloge II za odobritev.
The residues of the plant protection products, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements:
Ostanki fitofarmacevtskih sredstev kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe izpolnjujejo naslednje zahteve:
they shall not have any harmful effects on human health, including that of vulnerable groups, or animal health, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available, or on groundwater;
nimajo škodljivih vplivov na zdravje ljudi, vključno z ranljivimi skupinami, ali zdravje živali, ob upoštevanju znanih kumulativnih in sinergijskih učinkov, kadar so na voljo znanstvene metode za ocenjevanje takšnih učinkov, ki jih priznava Agencija, ali vplivov na podzemno vodo;
they shall not have any unacceptable effect on the environment.
nimajo nobenega nesprejemljivega vpliva na okolje.
For residues which are of toxicological, ecotoxicological, environmental or drinking water relevance, there shall be methods in general use for measuring them.
Za merjenje ostankov, ki so relevantni s toksikološkega, eko-toksikološkega, okoljskega vidika in vidika pitne vode, se uporabljajo splošno razširjene metode.
Analytical standards shall be commonly available.
Analitski standardi morajo biti splošno dostopni.
A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements:
Fitofarmacevtsko sredstvo kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe izpolnjuje naslednje zahteve:
it shall be sufficiently effective;
je dovolj učinkovito;
it shall have no immediate or delayed harmful effect on human health, including that of vulnerable groups, 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 scientific methods accepted by the Authority to assess such effects are available; or on groundwater;
nima takojšnjega ali zapoznelega škodljivega vpliva na zdravje ljudi, vključno z ranljivimi skupinami, ali zdravje 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 na voljo znanstvene metode za ocenjevanje takšnih vplivov, ki jih priznava Agencija, ali vpliva na podzemno vodo;
it shall not have any unacceptable effects on plants or plant products;
nima nobenega nesprejemljivega vpliva na rastline ali rastlinske proizvode;
it shall not cause unnecessary suffering and pain to vertebrates to be controlled;
ne povzroča nepotrebnega trpljenja in bolečin vretenčarjem, zatiranju katerih je namenjena;
it shall have no unacceptable effects on the environment, having particular regard to the following considerations where the scientific methods accepted by the Authority to assess such effects are available:
nima nesprejemljivega vpliva na okolje, zlasti ob upoštevanju naslednjih dejavnikov, kadar so na voljo znanstvene metode za ocenjevanje takšnih vplivov, ki jih priznava Agencija:
its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, groundwater, air and soil taking into account locations distant from its use following long-range environmental transportation;
usode in obnašanja teh sredstev v okolju, zlasti onesnaženja površinskih voda, rečnih ustij in obalnih vod, podtalne vode, zraka in tal, ob upoštevanju lokacij, oddaljenih od kraja uporabe snovi, po prenosu v okolju na velike razdalje;
its impact on non-target species, including on the ongoing behaviour of those species;
njenega vpliva na neciljne vrste, zlasti na njihovo trenutno vedenje;
its impact on biodiversity and the ecosystem.
njenega vpliva na biotsko raznovrstnost in ekosistem.
The requirements of paragraphs 2 and 3 shall be evaluated in the light of uniform principles as referred to in Article 29(6).
Zahteve iz odstavkov 2 in 3 se ocenijo skladno z enotnimi načeli iz člena 29(6).
For approval of an active substance, paragraphs 1, 2 and 3 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance.
Aktivna snov se odobri, kadar so izpolnjene zahteve iz odstavkov 1, 2 in 3, in kadar je bilo to ugotovljeno v zvezi z eno ali več reprezentativnimi rabami vsaj enega fitofarmacevtskega sredstva, ki vsebuje to aktivno snov.
In relation to human health, no data collected on humans shall be used to lower the safety margins resulting from tests or studies on animals.
V zvezi z zdravjem ljudi se podatki, pridobljeni v okviru raziskav, opravljenih na ljudeh, ne smejo uporabiti za znižanje mej varnosti, ki so posledica preskusov ali študij na živalih.
By way of derogation from paragraph 1, where on the basis of documented evidence included in the application an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but 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.
Z odstopanjem od odstavka 1 ter če je na podlagi dokumentiranih dokazov, priloženih zahtevku, aktivna snov potrebna za nadzor resne nevarnosti za zdravje rastlin, ki je ni mogoče obvladati na drugačen način, niti z uporabo nekemičnih metod, se takšna aktivna snov lahko odobri za omejeno obdobje, ki je potrebno za obvladovanje te nevarnosti, vendar 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.
For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005.
Za te snovi se mejne vrednosti ostankov določijo v skladu z Uredbo (ES) št. 396/2005.
This derogation shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A.
Odstopanje se ne uporablja za aktivne snovi, ki so ali morajo biti razvrščene v skladu z Uredbo (ES) št. 1272/2008, kot rakotvorne iz skupine 1A, rakotvorne iz skupine 1B brez določene vrednosti praga delovanja ali strupene za razmnoževanje iz skupine 1A.
Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control that serious danger to plant health in their territory.
Države članice lahko odobrijo fitofarmacevtska sredstva, ki vsebujejo aktivne snovi, odobrene v skladu s tem odstavkom, samo kadar je to nujno za obvladovanje resne nevarnosti za zdravje rastlin na njihovem ozemlju.
At the same time, they shall draw up a phasing out plan concerning the control of the serious danger by other means, including non-chemical methods, and shall without delay transmit that plan to the Commission.
Države članice hkrati oblikujejo načrt postopnega opuščanja za obvladovanje resne nevarnosti na drugačen način, zlasti z nekemičnimi metodami, in ga nemudoma posredujejo Komisiji.
First approval
Prva odobritev
First approval shall be for a period not exceeding 10 years.
Prva odobritev velja največ deset let.
Approval may be subject to conditions and restrictions including:
Za odobritev lahko veljajo pogoji in omejitve, vključno z:
the minimum degree of purity of the active substance;
najmanjšo stopnjo čistosti aktivne snovi;
the nature and maximum content of certain impurities;
vrsto in najvišjo dovoljeno vsebnost določenih nečistoč;
restrictions arising from the evaluation of the information referred to in Article 8 taking account of the agricultural, plant health and environmental, including climatic, conditions in question;
omejitvami na podlagi ocene podatkov iz člena 8, ob upoštevanju dejanskih kmetijskih razmer, razmer varstva rastlin in okoljskimi razmerami, vključno s podnebnimi razmerami;
type of preparation;
vrsto pripravka;
manner and conditions of application;
načinom in pogoji uporabe;
submission of further confirmatory information to Member States, the Commission and the European Food Safety Authority, (the Authority), where new requirements are established during the evaluation process or as a result of new scientific and technical knowledge;
predložitvijo dodatnih podatkov potrditvene narave državam članicam, Evropski agenciji za varnost hrane (Agencija) in Komisiji, kadar se zaradi novih znanstvenih in tehničnih spoznanj ali med postopkom ocenjevanja določijo nove zahteve;
designation of categories of users, such as professional and non-professional;
določitev kategorij uporabnikov, kot so poklicni in nepoklicni uporabniki;
designation of areas where the use of plant protection products, including soil treatment products, containing the active substance may not be authorised or where the use may be authorised under specific conditions;
določitvijo območij, na katerih se uporaba fitofarmacevtskih sredstev, ki vsebujejo aktivno snov, vključno s sredstvi za tretiranje tal, ne sme registrirati ali kjer se uporaba lahko registrira pod posebnimi pogoji;
the need to impose risk mitigation measures and monitoring after use;
potrebo po uveljavitvi ukrepov za zmanjšanje tveganja ter spremljanje in nadzorovanje po uporabi;
any other particular conditions that result from the evaluation of information made available in the context of this Regulation.
vsemi drugimi posebnimi pogoji, ki so posledica ocenjevanja podatkov, ki so na voljo v okviru te uredbe.
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, (the 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 državi članici (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.
A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.
Združenje proizvajalcev, ki ga imenujejo proizvajalci za zagotovitev skladnosti s to uredbo, lahko predloži skupni zahtevek.
The application shall be examined by the Member State proposed by the applicant, unless another Member State agrees to examine it.
Zahtevek preuči država članica, ki jo je predlagal vlagatelj, razen če s preučitvijo soglaša druga država članica.
Assessment of an application may be performed by a number of Member States together under a co-rapporteur system.
Zahtevek lahko oceni več držav skupaj po sistemu so-poročanja.
When submitting the application, the applicant may pursuant to Article 63 request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.
Ob predložitvi zahtevka lahko vlagatelj v skladu s členom 63 zaprosi, da nekatere informacije in nekateri deli dokumentacije ostanejo zaupni, in take podatke fizično loči.
Member States shall assess the confidentiality requests.
Države članice ocenijo zahtevke po zaupnosti.
Upon a request for access to information, the rapporteur Member State shall decide what information is to be kept confidential.
Ob predložitvi zahteve za dostop do informacij se država članica poročevalka odloči, katere informacije bodo ostale zaupne.
When submitting the application the applicant shall at the same time join a complete list of tests and studies submitted pursuant to Article 8(2) and a list of any claims for data protection pursuant to Article 59.
Vlagatelj ob predložitvi zahtevka predloži tudi popoln seznam preskusov in študij, predloženih v skladu s členom 8(2), in seznam zahtevkov za varovanje podatkov v skladu s členom 59.
When assessing the application the rapporteur Member State may at any time consult the Authority.
Pri oceni zahtevka se lahko država članica poročevalka kadar koli posvetuje z Agencijo.
information with respect to one or more representative uses on a widely grown crop in each zone of at least one plant protection product containing the active substance, demonstrating that the approval criteria provided for in Article 4 are met; where the information submitted does not cover all zones or concern a crop which is not widely grown, justification for this approach;
informacije v zvezi z eno ali več reprezentativnimi rabami vsaj enega fitofarmacevtskega sredstva, ki vsebuje aktivno snov, na splošno razširjenem posevku v vsaki coni, ki dokazujejo, da so izpolnjena merila za odobritev iz člena 4; kadar pa predložene informacije ne zajemajo vseh con ali zadevajo posevek, ki ni splošno razširjen, pa je treba takšen pristop utemeljiti;
for each point of the data requirements for the active substance, the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies;
za vsako točko zahtev po podatkih o aktivni snovi povzetke in rezultate preskusov in študij, ime njihovega imetnika ter osebe ali ustanove, ki je izvajal preskuse in študije;
for each point of the data requirements for the plant protection product, the summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies, relevant to the assessment of the criteria provided for in Article 4(2) and (3) for one or more plant protection products which are representative of the uses referred to in point (a), taking into account the fact that data gaps in the dossier, as provided for in paragraph 2 of this Article, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the approval;
za vsako točko zahtev po podatkih o fitofarmacevtskih sredstvih povzetke in rezultate preskusov in študij, ime njihovega lastnika ter osebe ali ustanove, ki je izvajala preskuse in študije, ki so povezani z ocenjevanjem meril iz člena 4(2) in (3) za eno ali več fitofarmacevtskih sredstev, reprezentativnih za rabo iz točke (a), ob upoštevanju dejstva, da lahko manjkajoči podatki v dokumentaciji, kakor je določeno v odstavku 2 tega člena, ki so rezultat predlaganega omejenega obsega reprezentativnih rab aktivne snovi, privedejo do omejitev odobritve;
for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals;
za vsak preskus ali študijo, ki vključuje vretenčarje, utemeljitev ukrepov, sprejetih za preprečitev poskusov na živalih in podvajanja poskusov in študij na vretenčarjih;
a checklist demonstrating that the dossier provided for in paragraph 2 of this Article is complete in view of the uses applied for;
kontrolni seznam, ki dokazuje, da je dokumentacija iz odstavka 2 tega člena popolna glede na uporabo, na katero se nanaša vloga;
the reasons why the test and study reports submitted are necessary for first approval of the active substance or for amendments to the conditions of the approval;
razloge, zakaj so predložena poročila o preskusih in študijah nujna za prvo odobritev ali za spremembo pogojev odobritve;
where relevant, a copy of an application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information;
kopijo zahtevka za mejno vrednost ostankov iz člena 7 Uredbe (ES) št. 396/2005, kjer je to ustrezno, oziroma utemeljitev, zakaj ti podatki niso priloženi;
The complete dossier shall contain the full text of the individual test and study reports concerning all the information referred to in points (b) and (c) of paragraph 1.
Popolna dokumentacija vključuje celotno besedilo poročil o posameznih preskusih in študijah v zvezi z vsemi informacijami iz točk (b) in (c) odstavka 1.
It shall not contain any reports of tests or studies involving the deliberate administration of the active substance or the plant protection product to humans.
Ne vključuje poročil o preskusih ali študijah, ki vključujejo namerni vnos aktivne snovi ali fitofarmacevtskega sredstva v ljudi.
The format of the summary dossier and the complete dossier shall be established in accordance with the advisory procedure referred to in Article 79(2).
Oblika povzetka dokumentacije in popolne dokumentacije se določi v skladu s svetovalnim postopkom iz člena 79(2).
The data requirements referred to in paragraphs 1 and 2 shall contain the requirements for active substances and plant protection products as set out in Annexes II and III to Directive 91/414/EEC and laid down in Regulations adopted in accordance with the advisory procedure referred to in Article 79(2) without any substantial modifications.
Zahteve po podatkih iz odstavkov 1 in 2 vsebujejo zahteve za aktivne snovi in fitofarmacevtska sredstva, navedena v prilogah II in III k Direktivi 91/414/EGS in določena v uredbah, ki se brez vsebinskih sprememb sprejmejo v skladu s svetovalnim postopkom iz člena 79(2).
Subsequent amendments to these Regulations shall be adopted in accordance with Article 78(1)(b).
Nadaljnje spremembe teh uredb se lahko sprejmejo v skladu s členom 78(1)(b).
Scientific peer-reviewed open literature, as determined by the Authority, on the active substance and its relevant metabolites dealing with side-effects on health, the environment and non-target species and published within the last 10 years before the date of submission of the dossier shall be added by the applicant to the dossier.
Vlagatelj dokumentaciji priloži strokovno pregledano javno dostopno znanstveno literaturo, kakor jo določa Agencija, o aktivnih snoveh in njihovih relevantnih metabolitih v zvezi s stranskimi učinki na zdravje, okolje in neciljne vrste, ki je bila objavljena v zadnjih desetih letih pred datumom predložitve dokumentacije.
Admissibility of the application
Dopustnost zahtevka
Within 45 days of receiving the application, the rapporteur Member State shall send the applicant a written acknowledgement, stating the date of receipt, and check whether the dossiers submitted with the application contain all the elements provided for in Article 8, using the checklist referred to in point (e) of Article 8(1).
V 45 dneh po prejemu zahtevka država članica poročevalka vlagatelju pošlje pisno potrdilo z navedbo datuma prejema ter z uporabo kontrolnega seznama iz člena 8(1)(e) preveri, ali dokumentacija, predložena z zahtevkom, vsebuje vse elemente iz člena 8.