natgillin/translations-raw huggingface dataset:
Glej obrazložitev k členu 56, odstavek 1.
See justification for Article 56, paragraph 1.
Katere koli osebe, ki želijo pridobiti, podaljšati ali pregledati registracijo za fitofarmacevtsko sredstvo, pred izvajanjem poskusov ali študij preverijo pri pristojnem organu države članice, v kateri želijo vložiti zahtevek, ali je bilo v zadevni državi članici že registrirano fitofarmacevtsko sredstvo, ki vsebuje enako aktivno snov, varovalo ali enak sinergist.
Any persons intending to seek , renew or review an authorisation for a plant protection product shall, before carrying out tests or studies, enquire of the competent authority of the Member State to which they intend to make an application whether an authorisation has already been granted in that Member State for a plant protection product containing the same active substance, safener or synergist.
Člen 58, odstavek 1, pododstavek 2
Article 58, paragraph 1, subparagraph 2
Morebitni vlagatelj predloži podatke v zvezi z vrsto in nečistočami aktivne snovi, ki jo želi uporabiti.
The prospective applicant shall submit all data regarding the identity and impurities of the active substance he proposes to use.
Pri takšni poizvedbi mora morebitni vlagatelj dokazati, da namerava vložiti zahtevek za registracijo.
The enquiry shall be supported by evidence that the prospective applicant intends to apply for an authorisation.
Ni primerno, da se zahtevek obravnava, še preden je bil uradno vložen.
It is not appropriate for an application to be considered before being officially submitted.
Zadostujejo informacije iz člena 54.
The information referred to in Article 54 is sufficient.
Če ima pristojni organ države članice dokaz, da morebitni vlagatelj namerava vložiti zahtevek za registracijo , njeno podaljšanje ali pregled, mu zagotovi ime in naslov imetnika ali imetnikov obstoječih zadevnih registracij ter hkrati sporoči imetnikom registracij ime in naslov vlagatelja.
The competent authority of the Member State, where satisfied that the prospective applicant intends to apply for an authorisation, or the renewal or review thereof, shall provide him with the name and address of the holder or holders of previous relevant authorisations and shall at the same time inform the holders of the authorisations of the name and address of the applicant.
Glej obrazložitev k členu 58, odstavek 1, pododstavek 1.
See justification for Article 58 paragraph 1 subparagraph 1.
Morebitni vlagatelj registracije, njenega podaljšanja ali pregleda, in imetnik ali imetniki zadevnih registracij sprejmejo vse ustrezne ukrepe za dosego dogovora o izmenjavi poročil o poskusih in študijah, varovanih v skladu s členom 56, ki jih zahteva vlagatelj za registracijo fitofarmacevtskega sredstva, za njeno podaljšanje ali pregled .
The prospective applicant for the authorisation, or the renewal or review thereof, and the holder or holders of relevant authorisations shall take all reasonable steps to reach agreement on the sharing of any test and study reports protected under Article 56 that are required by the applicant for the authorisation, or the renewal or review, of a plant protection product.
Člen 58, odstavek 3 a (novo)
Article 58, paragraph 3 a (new)
Če država članica meni, da bo prišlo do nastanka monopola, ker se morebitni vlagatelj in imetnik ali imetniki zadevnih registracij fitofarmacevtskih sredstev, ki vsebujejo enako aktivno snov, varovalo ali enak sinergist, ne morejo sporazumeti o izmenjavi poročil o poskusih in študijah, ki vključujejo vretenčarje, potencialni vlagatelj o tem obvesti pristojni organ države članice.
Where the Member State considers that a monopoly may be created, if the prospective applicant and the holder or holders of the relevant authorisations of plant protection products containing the same active substance, safener or synergist cannot reach agreement on the sharing of tests and studies involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State.
Ne glede na to se morajo potencialni vlagatelj in imetnik ali imetniki zadevnih registracij dogovoriti o pristojnem sodišču za namene pododstavka 2.
The two parties shall nevertheless agree which courts have jurisdiction for the purpose of the second subparagraph.
Nova uredba bi morala vsebovati posebne določbe, ki bi preprečevale nastanek monopolov na trgu fitofarmacevtskih sredstev.
The new regulation should contain specific provisions to prevent monopolies being created in the plant protection products market.
Morebitni vlagatelj krije stroške le za tiste informacije, ki jih mora predložiti za izpolnitev zahtev za registracijo .
The prospective applicant is only required to share in the costs of information he is required to submit to meet the authorisation requirements.
Stroški izmenjave poročil o poskusih in študijah se določijo na pošten, pregleden in nediskriminatoren način.
The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way.
Morebitni vlagatelj krije vse stroške, nastale s pridobivanjem izmenjanih informacij .
The prospective applicant is required to share the full cost of generating the information shared .
V zvezi s stroški, ki jih je treba upoštevati, se sprejme uredba v skladu s postopkom iz člena 76(3).
A regulation shall be adopted in accordance with the procedure referred to in Article 76(3) concerning the costs that shall be taken into account.
Če je osnova za izračun stroškov, ki se delijo po tej uredbi, preveč omejena, so na slabšem podjetja, ki veliko vlagajo v raziskave in poskuse, kar bi bil hud udarec za najbolj inovativna podjetja na tem področju.
If the basis of calculating the costs shared under this provision is too limited, those companies that invest heavily in research and testing are at a disadvantage, which would be a blow to the most innovative companies in this field.
Podjetja, ki želijo uporabiti podatke drugih podjetij, bi morala vsaj dokazati, da so predložila ustrezno finančno ponudbo, preden se jim dovoli uporaba zadevnih podatkov.
Companies wanting to use other companies' data shall at least prove that they have made a substantial financial offer before they can use the data concerned.
Člen 59, odstavek 3, pododstavek 1
Article 59, paragraph 3, subparagraph 1
Če se morebitni vlagatelj in imetnik ali imetniki zadevnih registracij fitofarmacevtskih sredstev, ki vsebujejo enako aktivno snov, varovalo ali enak sinergist, ne morejo sporazumeti o izmenjavi poročil o poskusih in študijah, ki vključujejo vretenčarje, morebitni vlagatelj obvesti pristojni organ države članice .
Where the prospective applicant and the holder or holders of the relevant authorisations of plant protection products containing the same active substance, safener or synergist cannot reach agreement on the sharing of test and study reports involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State .
Kljub temu pa se morajo morebitni vlagatelj in imetnik ali imetniki zadevnih registracij dogovoriti o pristojnem sodišču za namen pododstavka 2.
The two parties shall nevertheless agree which courts have jurisdiction for the purpose of the second subparagraph .
Če se morebitni vlagatelj in imetnik ali imetniki zadevnih registracij fitofarmacevtskih sredstev, ki vsebujejo enako aktivno snov, varovalo ali enak sinergist, ne morejo sporazumeti o izmenjavi poročil o poskusih in študijah, ki vključujejo vretenčarje, se uporablja postopek, določen v členu 58(3) in (3a) .
Where the prospective applicant and the holder or holders of the relevant authorisations of plant protection products containing the same active substance, safener or synergist cannot reach agreement on the sharing of test and study reports involving vertebrate animals, the procedure laid down in Article 58(3) and (3a) shall apply .
Pri izmenjavi rezultatov poskusov in študij, ki vključujejo živali, je sistem, ki velja za pogajanja in pravična nadomestila, enak tistemu, ki je določen v splošnih pravilih za izogibanje podvajanju poskusov.
As regards the sharing of the results of tests and studies involving animals, the system established for negotiation and fair compensation is the same as that provided for in the general rules for avoiding the repetition of tests.
V sistemu je predvidena tudi rešitev za tiste primere, ko se različne strani ne uspejo same dogovoriti.
This system also provides a solution in those cases in which the parties do not come to an agreement.
Člen 60, odstavek 2, uvodni del
Article 60, paragraph 2, introductory part
Glede na poslovne interese iz odstavka 1 se za zaupne štejejo le :
As regards the commercial interests referred to in paragraph 1, only the following elements shall be considered confidential:
Glede na poslovne interese iz odstavka 1 se za zaupne vedno štejejo:
As regards the commercial interests referred to in paragraph 1, the following elements shall always be considered confidential:
Treba bi bilo upoštevati, da so zaupne narave tudi nekateri drugi podatki, ne samo tisti iz točk a) do c).
It should not be excluded that other relevant data than those mentioned in points a) - c) are considered confidential.
(ca) Imena in naslovi ustanov in oseb, ki sodelujejo pri poskusih na vretenčarjih.
(ca) Names and addresses of institutions and persons involved in testing on vertebrate animals.
Podatke o poskusih, vključno s poročili o študijah, ki jih je vlagatelj predložil v podporo odločitvi o registraciji ali spremembi fitofarmacevtskega sredstva v skladu s to uredbo, si zainteresirane strani lahko ogledajo na posebnih mestih, ki jih določijo Komisija, pristojni organ ali države članice.
Test data, including study reports, which have been provided by an applicant to support a decision to authorise or amend a plant protection product under this regulation may be viewed by interested parties in specific locations identified by the Commission, the Authority or the Member States .
Taki podatki javnosti niso dostopni v obliki kopij ali prek drugačnih načinov objave (vključno z objavo v elektronski obliki).
Such data shall not be made public through the provision of copies or through any other means of publication (including electronic publication).
Člen 63, odstavek 2 a (novo)
Article 63, paragraph 2 a (new)
Države članice lahko prepovejo ali omejijo oglaševanje fitofarmacevtskih sredstev v nekaterih sredstvih javnega obveščanja.
Member States may prohibit or restrict the advertising of plant protection products in certain media.
Člen 64, odstavek 1, pododstavek 1
Article 64, paragraph 1, subparagraph 1
Obveznost poklicnih uporabnikov, da vodijo evidence, ne sme biti strožja od tiste, ki jo nalaga Uredba (ES) št. 852/2004.
The obligation to keep records imposed on professional users shall not be more demanding than that imposed by Regulation (EC) No 852/2004.
Birokratsko breme vodenja evidenc ne sme biti večje od tistega iz Uredbe (ES) št. 852/2004.
Bureaucratic burden for record keeping should not exceed the burden under Regulation (EC) No. 852/2004.
Člen 64, odstavek 1, pododstavek 2
Article 64, paragraph 1, subparagraph 2
Na zahtevo pristojnega organa dajo na voljo ustrezne podatke iz teh evidenc.
They shall make the relevant information contained in these records available to the competent authority on request.
Zagotavljanje informacij pristojnim organom zadostuje.
It is sufficient to keep plant protection information for the authority.
Vsakršna obveznost, ki presega trenutno vodenje evidenc, je v nasprotju s prizadevanji za zmanjšanje birokracije in upravnih stroškov.
Any obligation going beyond the current obligation to keep records contradicts efforts to cut red tape and reduce administrative costs.
Člen 73, odstavek 1, točka (i a) (novo)
Article 73, paragraph 1, point (i a) (new)
(ia) izvajanja poskusov na manj razširjenih posevkih.
(ia) Performance of experiments on minor crops.
Opaziti je bilo, da imetniki dovoljenj zaradi visokih stroškov niso naklonjeni razširitvi registracij na uporabo v manjši meri.
It has been noted that authorisation holders are reluctant to extend authorisations to minor uses because of the high cost.
Potrebne so spodbude, da bi preprečili pomanjkanje fitofarmacevtskih sredstev za te vrste posevka.
Incentives are required to avoid a shortage of plant protection products for this type of crop.
Člen 74 a (novo)
Article 74 a (new)
Člen 74a
Article 74a
Komisija v treh letih od datuma, navedenega v prvem odstavku člena 80, predloži Evropskemu parlamentu in Svetu poročilo, ki navaja izkušnje, pridobljene z medsebojnim priznavanjem odločb o registraciji na nekem območju in preko njegovih meja ter o tem, koliko je mogoče na osnovi teh izkušenj nadomestiti registracijo po območjih z evropskim sistemom registracije.
Within three years after the date referred to in Article 80, first paragraph, the Commission shall submit a report to the European Parliament and the Council which gives an account of the experience gained with regard to mutual recognition of authorisation decisions within a zone, and beyond zonal boundaries, and of the extent to which, on the basis of that experience, zone-based authorisation can be superseded by a European authorisation system.
Poročilu po potrebi priloži ustrezne zakonodajne predloge.
Its report shall be accompanied, if necessary, by appropriate legislative proposals.
Cilj te uredbe je usklajena registracija fitofarmacevtskih sredstev.
Harmonised authorisation of plant protection products is regarded as this regulation's objective.
K temu bi lahko prispevala redna poročila Komisije Svetu in Parlamentu.
A regular Commission report to the Council and Parliament would contribute towards that.
Člen 74 b (novo)
Article 74 b (new)
Article 74b
Article 74b
Komisija preveri učinkovitost te uredbe in njeno skladnost z notranjim trgom ter v treh letih po njeni objave, nato pa vsakih pet let, predloži Evropskemu parlamentu in Svetu poročilo, ki mu po potrebi priloži ustrezne predloge sprememb.
The Commission shall verify the effectiveness and internal-market conformity of this Regulation and within three years following its publication, and every five years thereafter, shall submit a report to the European Parliament and the Council, accompanied, if necessary, by appropriate proposals for amendments.
Pri tem zlasti upošteva, do kakšne mere se je izoblikoval notranji trg za fitofarmacevtske izdelke.
Account shall be taken in particular of the extent to which the internal market for plant protection products has been established.
Komisija bi morala preveriti skladnost te uredbe z načeli notranjega trga in v primeru neskladnosti predložiti predloge sprememb, ki bi vnesli skladnost na notranji trg.
The Commission should verify conformity of this regulation with the principles of the internal market and, if there are incompatibilities with the internal market, should submit proposals for amendments so as to bring about internal-market conformity.
Člen 77, odstavek 2, alinea 3
Article 77, paragraph 2, indent 3
za obdobje petih let od datuma podaljšanja vključitve ali obnovitve odobritve za aktivne snovi, katerih vključitev v Prilogo I k Direktivi se izteče najpozneje dve leti po datumu objave te uredbe.
- For a period of five years from the date of the renewal of the inclusion or renewal of the approval, for active substances whose inclusion in Annex I to the Directive expires at the latest two years after the date of publication of this Regulation.
Ta določba se uporablja le za podatke, ki so potrebni za obnovitev odobritve in so bili potrjeni kot skladni z načeli dobre laboratorijske prakse, najpozneje dve leti po objavi te uredbe.
This provision shall only apply to data necessary for the renewal of the approval and which were certified as compliant with the principles of Good Laboratory practice at the latest two years after the publication of Regulation.
Varstvo podatkov in zaupnost bi morala veljati za vse s tem povezane podatke, ne samo za tiste, ki so v skladu z dobro laboratorijsko prakso.
Data protection and confidentiality should apply to all relevant data, not only to those compliant with GLP.
Člen 77, odstavek 3
Article 77, paragraph 3
Če se člen 13 Direktive uporablja na podlagi odstavka 1 ali odstavka 2, zanj veljajo vsa posebna pravila v zvezi z Direktivo, ki so določena v Aktu o pristopu, s katerim je država članica pristopila k Skupnosti.
Where Article 13 of the Directive applies by virtue of paragraph 1 or paragraph 2, it shall be subject to any special rules concerning the Directive laid down in the Act of Accession by which a Member State joined the Community.
V primerih, navedenih v zgornjih odstavkih 1 in 2, veljajo določbe člena 58.
In the cases covered by paragraphs 1 and 2 above, the provisions of Article 58 shall apply.
Pri aktivnih snoveh in obstoječih formuliranih izdelkih, na primer tistih, ki so bili 26. julija 1993 že na trgu in za katere veljajo prehodni ukrepi, ne bi smelo biti dvoma glede učinkovitega izvajanja sistema obveznega pogajanja in poštenega nadomeščanja, ki ga uvaja ta uredba.
There should be no room for doubt surrounding the effective application of the compulsory negotiation and fair compensation system established in this Regulation as regards active substances and ‘existing’ formulated products – i.e. those that were already on the market on 26 July 1993 and that are covered by transitional measures.
Preprečevati malim in srednje velikim podjetjem, da po ustreznih pogajanjih in finančnemu nadomestilu dostopajo do podatkov, ki so bistveni za registracijo formulacij, ki vsebujejo že obstoječe aktivne snovi, bi lahko imelo hude posledice za njihovo preživetje in za kmetijstvo, saj bi zaradi umika fitofarmacevtskih sredstev in izdelkov, ki so bistveni v boju proti boleznim ključnih pridelkov, ustvarjali vrzel v razpoložljivosti fitofarmacevtskih sredstev.
Preventing SMEs from gaining access – always in return for negotiation and financial compensation – to data that are vital to maintain the authorisations relating to formulated products containing ‘existing active substances’ would have extremely serious consequences in terms of their survival, and would affect agriculture by creating gaps in the plant protection industry as a result of the withdrawal of plant protection substances and products that are vital in combating disease occurring in key crops.
Priloga se črta.
Annex deleted.
Tak način opredelitev območij se zdi neprimeren, ker opredeljena območja niso dovolj enotna.
This type of zoning seems inappropriate since the zones defined are not sufficiently homogenous.
Priloga II, točka 3.6.1
Annex II, point 3.6.1
Pri določanju teh vrednosti se zagotovi primerna meja varnosti, ob upoštevanju vrste in resnosti učinkov ter ranljivosti posebnih skupin prebivalstva , kot so ženske v rodni dobi, zarodki, plodovi in otroci do konca pubertete .
When establishing such values an appropriate safety margin shall be ensured taking into account the type and severity of effects and the vulnerability of specific groups of the population , such as women of reproductive age, embryos, foetuses and children up to the end of puberty .
Priloga II 3.6.2 - 3.6.5
Annex II 3.6.2 - 3.6.5
Aktivna snov se odobri le, če ocena, opravljena v skladu z enotnimi načeli, pod priporočenimi pogoji uporabe kaže sprejemljivo raven zaščite uporabnikov, delavcev, drugih prisotnih oseb in potrošnikov pri vsaj eni reprezentativni uporabi vsaj enega fitofarmacevtskega sredstva .
An active substance shall only be approved if an evaluation carried out in accordance with the Uniform Principles shows, under the recommended conditions of use, acceptable protection of users, workers, bystanders and consumers in respect of at least one representative use of at least one plant protection product.
Omejitvena merila precej zmanjšujejo število registriranih sredstev.
Cut off criteria limit the range of authorised products considerably.
Postopek registracije, ki ne upošteva dejanskih načinov uporabe in izpostavljenosti, spodkopava načelo, da morajo odločitve temeljiti na ocenah tveganja.
An authorisation procedure that does not take actual uses and exposures into account undermines the principle of decisions based on risk assessments.
Posledica tega bo postopna prepoved številnih varnih proizvodov/načinov uporabe.
It will result in phasing out many safe products/uses.
Ta merila bi bilo treba uporabiti za določitev snovi, ki jih je treba nadomestiti, ne pa za zavrnitev snovi brez pravega ocenjevanja.
These criteria should be used to identify substances as candidates for substitution and not to reject substances without proper evaluation.
Priloga II, točka 3.7.1, pododstavek 2, točka (c), točka (ii)
Annex II, point 3.7.1, subparagraph 2, point (c), point (ii)
spremljanje podatkov, ki kažejo, da je do prenosa aktivne snovi v okolju na velike razdalje, z možnostjo prenosa v sprejemno okolje, lahko prišlo po zraku , vodi ali s selivskimi vrstami ; ali
(ii) Monitoring data showing that long-range environmental transport of the active substance, with the potential for transfer to a receiving environment, may have occurred via air, water or migratory species ; or
spremljanje podatkov, ki kažejo, da je do prenosa aktivne snovi v okolju na velike razdalje, z možnostjo prenosa v sprejemno okolje, lahko prišlo po zraku ali vodi;
(ii) Monitoring data showing that long-range environmental transport of the active substance, with the potential for transfer to a receiving environment, may have occurred via air or water;
Za navedbo selivskih vrst ni znanstvene razlage.
There is no scientific justification for a reference to migratory species.
Priloga II 3.7.2 - 3.7.3
Annex II 3.7.2 - 3.7.3
Snov, ki izpolnjuje vsa tri merila, navedena spodaj, je snov z lastnostmi
A substance that fulfils all three of the criteria of the sections below is a
snovi PBT.
PBT substance.
Ocena obstojnosti v okolju temelji na razpoložljivih podatkih o razpolovni dobi, ki so zbrani v skladu z ustreznimi pogoji, ki jih določi vlagatelj.
Assessment of persistency in the environment shall be based on available half-life data collected under appropriate conditions, which shall be described by the applicant.
Ocena akumulacije temelji na izmerjenih podatkih o koncentraciji v vodnih vrstah.
Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species.
Aktivna snov izpolnjuje merilo toksičnosti, če:
An active substance fulfils the toxicity criterion where:
Snov, ki izpolnjuje obe spodaj navedeni merili, je snov z lastnostmi vPvB.
A substance that fulfils both of the criteria of the sections below is a vPvB substance.
Registracija bi morala temeljiti na oceni tveganja.
Authorisation should be based on risk assessments.
Dejanska tveganja fitofarmacevtskih proizvodov kot tudi vseh drugih proizvodov so odvisna od dejanske uporabe, doziranja in drugih dejavnikov.
The actual risks for plant protection products as well as for any other product are based on the actual use as well as on dosage and other factors.
Predlagana merila ne odražajo resničnih tveganj za okolje.
The proposed criteria do not reflect the real risks for the environment.
Priloga II 3.8.2
Annex II 3.8.2
Toksični učinki, ki se kažejo v obliki endokrinih motenj, so že urejeni z najvišjimi ravnmi izpostavljenosti, za katere je bilo ugotovljeno, da so varne za človeka in okolje.
Toxic effects proceeding through endocrine disruption are already covered by maximum exposure levels determined to be safe for humans and the environment.
Priloga II 4
Annex II 4
Aktivna snov se odobri kot možna nadomestna snov v skladu s
An active substance shall be approved as a candidate for substitution pursuant to
členom 24, če:
Article 24 where:
– so njene vrednosti SDV, ARO ali DRII bistveno nižje od vrednosti večine
– its ADI, ARfD or AOEL is significantly lower than those of the majority of the
odobrenih aktivnih snovi;
approved active substances;
– izpolnjuje dve merili, ki opredeljujeta snov z lastnostmi PBT;
– it meets two of the criteria to be considered as a PBT substance;
Aktivna snov se razvrsti in odobri kot snov , ki jo je treba v skladu s členom 24 nadomestiti , če:
An active substance shall be classified and approved as a candidate for substitution pursuant to Article 24 where: