qanastek/ELRC-Medical-V2 huggingface dataset:
English: The proposal also stipulates that personal data be protected taking into account the applicable Union legislative framework on the processing of such data.
Translation (en-hr): U prijedlogu se određuje i zaštita osobnih podataka s obzirom na primjenjivi zakonodavni okvir Unije o obradi tih podataka.
English: (19) In the case of applications to request the renewal of an authorisation, the authorised substance or product has already been on the market for several years.
Translation (en-hr): (19) U slučaju zahtjeva kojim se traži obnova odobrenja, odobrena tvar ili proizvod na tržištu je već nekoliko godina.
English: (b) breeding patterns and strategies.
Translation (en-hr): (b) uzgojni uzorci i strategije.
English: This is because companies going to laboratories outside the Union would take the risk to be perceived as evading the rules.
Translation (en-hr): To je tako jer poduzeća koja angažiraju laboratorije izvan EU-a preuzimaju rizik da ih se smatra osobama koje izbjegavaju pravila.
English: The public may make comments to the Commission within 30 days from such publication.
Translation (en-hr): Javnost Komisiji može uputiti svoje primjedbe u roku od 30 dana od takve objave.";
English: The fourth measure provides for controls and audits by Commission inspectors in relation to studies.
Translation (en-hr): Četvrta su mjera kontrole i revizije koje provode inspektori Komisije u vezi sa studijama.
English: The register shall be managed by the Authority.
Translation (en-hr): Registrom upravlja Agencija.
English: (b) proceed, without delay, to a concrete and individual examination of the confidentiality request in accordance with this Article;
Translation (en-hr): (b) bez odgode pristupiti konkretnom i individualnom razmatranju zahtjeva za povjerljivost u skladu s ovim člankom;
English: [43: Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx.]
Translation (en-hr): [43: Informacije o načinima upravljanja i upućivanju na Financijsku uredbu dostupne su na internetskim stranicama BudgWeb: https://myintracomm.ec.europa.eu/budgweb/HR/man/budgmanag/Pages/budgmanag.aspx.]
English: Ex-post evaluations/fitness checks of existing legislation
Translation (en-hr): Ex post evaluacije/provjere primjerenosti postojećeg zakonodavstva
English: of the multiannual financial framework (Total commitments = Total payments)
Translation (en-hr): višegodišnjeg financijskog okvira (ukupne preuzete obveze = ukupna plaćanja)
English: (i) A high level of scientific expertise;
Translation (en-hr): i. visoka razina stručnog znanja;
English: (a) the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) and Annex I to this Regulation; and,
Translation (en-hr): (a) plan studije za studije kojima se dokazuje učinkovitost dodatka hrani za životinje u smislu ciljeva njezine namjene kako je definirano u članku 6. stavku 1. i prilogu I. ovoj Uredbi; i
English: In addition to monitoring compliance, DG SANTE identifies and disseminates good practices in collaboration with the agencies.
Translation (en-hr): Osim što nadzire usklađenost, GU SANTE utvrđuje i širi dobre prakse u suradnji s agencijama.
English: (c) four members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and one from industry organisations.
Translation (en-hr): (c) četiri člana koji imaju pravo glasa a predstavljaju civilno društvo i interese prehrambenog lanca, konkretno jednog iz organizacija potrošača, jednog iz nevladinih organizacija za zaštitu okoliša, jednog iz organizacija poljoprivrednika i jednog iz industrijskih organizacija.
English: (a) to any intellectual property right which may exist over documents or their content; and,
Translation (en-hr): (a) pravo intelektualnog vlasništva koje može postojati nad dokumentima ili njihovim sadržajem; i
English: It shall forthwith transmit this opinion to the Commission, the authorisation-holder and the Member States.
Translation (en-hr): Ona odmah dostavlja to mišljenje Komisiji, nositelju odobrenja i državama članicama.
English: Moreover, public money should not be used to commission costly studies (several thousand to several million Euros) that will eventually help the industry to place a product on the market.
Translation (en-hr): Nadalje, javna sredstva ne bi se trebala upotrebljavati za naručivanje skupih studija (od nekoliko tisuća do nekoliko milijuna eura) koje će naposljetku pomoći industriji da proizvod stavi na tržište.
English: Those implementing acts shall be adopted in accordance with Article 58(2).
Translation (en-hr): Ti provedbeni akti donose se u skladu s člankom 58. stavkom 2.
English: Member States shall assess the confidentiality requests.
Translation (en-hr): Države članice procjenjuju zahtjeve za povjerljivost.
English: To address these issues, the Commission has come up with a wide ranging and ambitious proposal requiring a significant increase in the resources available to the EFSA to enable it to discharge its existing and proposed new responsibilities.
Translation (en-hr): Kako bi riješila te probleme, Komisija je sastavila iscrpan i ambiciozan prijedlog za koji je potrebno znatno povećanje resursa dostupnih EFSA-i kako bi ona mogla obaviti svoje postojeće i predložene nove odgovornosti.
English: Where the Commission considers that the continuation of the Authority is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose that the relevant provisions of this Regulation be amended accordingly or repealed.
Translation (en-hr): Ako Komisija smatra da daljnje postojanje Agencije više nije opravdano s obzirom na ciljeve, mandat i zadaće koji su joj dodijeljeni, ona može predložiti da se relevantne odredbe ove Uredbe u skladu s tim izmijene ili stave izvan snage.
English: (c) information on the complete composition of a plant protection product.
Translation (en-hr): (c) informacije o cjelokupnom sastavu proizvoda za zaštitu bilja.";
English: In parallel, the Commission's Scientific Advice Mechanism has been asked to prepare an opinion on the authorisation process of plant protection products.
Translation (en-hr): Istodobno je Komisijinu mehanizmu za znanstveno savjetovanje upućen zahtjev za pripremu mišljenja o procesu odobravanja sredstava za zaštitu bilja.
English: A public consultation on the initiative in all Union official languages was launched on 23 January 2018 and ran until 20 March 2018; 471 replies were received (318 from individuals and 153 from organisations).
Translation (en-hr): Javno savjetovanje o inicijativi na svim službenim jezicima Unije počelo je 23. siječnja 2018. i trajalo do 20. ožujka 2018.; zaprimljen je 471 odgovor (318 odgovora fizičkih osoba i 153 odgovora organizacija).
English: This should have a positive impact since experience from other Union agencies demonstrates that this model ensures efficient supervision of the functioning of agencies and coordinated views between the Union and national level.
Translation (en-hr): To bi trebalo imati pozitivan učinak jer iskustvo drugih agencija Unije pokazuje da taj model osigurava učinkoviti nadzor rada agencija i usklađena mišljenja na razini Unije i nacionalnoj razini.
English: In particular, there has been a decrease in the number of candidates applying to be members of the Scientific Panels.
Translation (en-hr): Točnije, zabilježen je pad broja kandidata koji se prijavljuju za članove znanstvenih panela.
English: For the purposes of this point ‘added value of Union involvement' is the value resulting from Union intervention which is additional to the value that would have been otherwise created by Member States alone.
Translation (en-hr): Za potrebe ove točke „dodana vrijednost angažmana Unije" vrijednost je intervencije Unije koja je dodana vrijednosti koju bi inače ostvarile države članice svojim zasebnim djelovanjima.
English: YES NO NO NO
Translation (en-hr): DA NE NE NE
English: It provides, amongst others, that food law must be based on risk analysis, except where this is not appropriate to the circumstances or the nature of the measure.
Translation (en-hr): Njome se utvrđuje, među ostalim, da se zakon o hrani mora temeljiti na analizi rizika, osim kada to nije primjereno okolnostima ili prirodi mjere.
English: The Commission does not see scope to simplify or reduce these steps as this could have a negative impact not only on the perception of the transparency of the system but also on ensuring that the evidence presented for EFSA's assessments is complete.
Translation (en-hr): Komisija smatra da nema prostora za pojednostavnjenje ili smanjivanje količine tih koraka jer bi to moglo negativno utjecati ne samo na poimanje transparentnosti sustava, nego i na osiguravanje potpunosti dokaza dostavljenih za procjene EFSA-e.
English: Information systems
Translation (en-hr): Informacijski sustavi
English: The proposal/initiative requires application of the flexibility instrument or revision of the multiannual financial framework.
Translation (en-hr): Za prijedlog/inicijativu potrebna je primjena instrumenta za financijsku fleksibilnost ili revizija višegodišnjeg financijskog okvira.
English: (17) Provisions exist on the content of applications for authorisations.
Translation (en-hr): (17) Postoje odredbe o sadržaju zahtjeva za izdavanje odobrenja.
English: GRAND TOTAL 34 60 85 85 85
Translation (en-hr): SVEUKUPNO 34 60 85 85 85
English: executive agencies
Translation (en-hr): izvršne agencije
English: The EFSA also regularly fine-tunes and strengthens its strict policies on independence, transparency and openness.
Translation (en-hr): EFSA redovito prilagođava i jača svoje stroge politike o neovisnosti, transparentnosti i otvorenosti.
English: Problems in relation to safety have a huge impact on consumers' confidence and consequently on market stability, trade flows and the climate for innovation.
Translation (en-hr): Problemi povezani sa sigurnošću znatno utječu na povjerenje potrošača, a time i na stabilnost tržišta, trgovinske tokove i inovacijsku klimu.
English: The reasons underlying differences in the assessments and conclusions of scientific bodies should be better communicated to the public in order to facilitate their understanding.
Translation (en-hr): O razlozima zbog kojih nastaju razlike u procjenama i zaključcima znanstvenih tijela trebalo bi bolje obavješćivati javnost radi lakšeg razumijevanja.
English: The proposal also provides for a better organisation of the Panels' work.
Translation (en-hr): Prijedlogom je predviđena i bolja organizacija rada panela.
English: It is proportionate to harmonise these rules while preserving, where needed, the specific balance of interests in sectoral legislations.
Translation (en-hr): Svrhovito je da se ta pravila usklade a istodobno, ondje gdje je to potrebno, očuva posebna ravnoteža interesa u sektorskom zakonodavstvu.
English: N° of requests for access to documents addressed to EFSA and the Commission.
Translation (en-hr): Broj zahtjeva za pristup dokumentima upućenima EFSA-i i Komisiji
English: (d) The nominations by the Member States, the selection by the Executive Director and the appointments by the Management Board shall be made on the basis of the following criteria:
Translation (en-hr): (d) Nominacije od strane država članica, odabir od strane ravnatelja i imenovanja od strane Upravnog vijeća temelje se na sljedećim kriterijima:
English: (11) Experience shows that the role of the Management Board of the Authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the Authority.
Translation (en-hr): (11) Iskustvo je pokazalo da se Upravno vijeće Agencije pretežno bavi administrativnim i financijskim pitanjima i ne utječe na neovisnost znanstvenog rada Agencije.
English: Divergences between Union and national risk assessors, however, do not necessarily question the work of the different scientific bodies.
Translation (en-hr): No neslaganje EU-ovih i nacionalnih procjenitelja rizika ne dovodi nužno u pitanje rad različitih znanstvenih tijela.
English: X The proposal/initiative has no financial impact on revenue.
Translation (en-hr): X Prijedlog/inicijativa nema financijski utjecaj na prihode.
English: The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents.
Translation (en-hr): Popis koji sastavlja Komisija dostavlja se Europskom parlamentu, zajedno s relevantnim popratnim dokumentima.
English: Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health, animal health or the environment, such information should be disclosed.
Translation (en-hr): Samo u vrlo ograničenim i iznimnim okolnostima kada se radi o predvidljivim učincima na zdravlje i hitnoj potrebi zaštite zdravlja ljudi, zdravlja životinja ili okoliša, te bi se informacije smjele objaviti.
English: Access shall be based at the minimum on a system requiring two factor authentication or providing an equivalent level of security.
Translation (en-hr): Za pristup mora biti obvezan barem autentifikacijski sustav s dva faktora ili sustav koji pruža ekvivalentnu razinu sigurnosti.
English: Human Resources
Translation (en-hr): Ljudski resursi
English: Their interplay can impact on the acceptability of the risk assessment by the general public.
Translation (en-hr): Njihovo međusobno djelovanje može utjecati na prihvatljivost procjene rizika u široj javnosti.
English: (12) The Management Board should be selected in such a way as to secure the highest standards of competence and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and the Commission.
Translation (en-hr): (12) Upravno vijeće treba biti odabrano tako da osigura najviše standarde stručnosti i širok raspon relevantnih iskustava raspoloživih među predstavnicima država članica, Europskog parlamenta i Komisije.
English: (15) It is essential to ensure the efficient operation of the Authority and to improve the sustainability of its expertise.
Translation (en-hr): (15) Od ključne je važnosti osigurati efikasan rad Agencije i poboljšati održivost njezine stručnosti.
English: (40) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council and delivered an opinion on […],
Translation (en-hr): (40) Provedeno je savjetovanje s Europskim nadzornikom za zaštitu podataka u skladu s člankom 28. stavkom 2. Uredbe (EZ) br. 45/2001 Europskog parlamenta i Vijeća, i on je dao mišljenje o […],
English: Provisions in relation to the nomination, selection and appointment of experts include strict criteria on independence, thus providing appropriate safeguards.
Translation (en-hr): Odredbe povezane s predlaganjem, odabirom i imenovanjem stručnjaka uključuju stroge kriterije za neovisnost i tako pružaju primjerenu zaštitu.
English: Alternatives considered:
Translation (en-hr): Razmatrana alternativna rješenja:
English: Further measures should also be put in place to ensure that scientific experts have the means to act independently.
Translation (en-hr): Trebalo bi uvesti i druge mjere kako bi se osiguralo da znanstveni stručnjaci mogu djelovati neovisno.
English: Risk communication is an essential part of the risk analysis process.
Translation (en-hr): Obavješćivanje o rizicima ključan je dio procesa analize rizika.
English: Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled.
Translation (en-hr): Te članove imenuje Vijeće u dogovoru s Europskim parlamentom na temelju popisa koji sastavlja Komisija a koji sadržava više imena nego što ima mjesta koja treba popuniti.
English: (4) the following Articles 32a, 32b, 32c, 32d and 32e are inserted:
Translation (en-hr): (4) Umeću se sljedeći članci 32.a, 32.b, 32.c i 32.e:
English: The relevant items shall be available to download, print and search through in an electronic format.
Translation (en-hr): Relevantne točke moraju biti dostupne za preuzimanje, ispis i pretraživanje u elektroničkom obliku.",
English: In particular:
Translation (en-hr): Posebno:
English: (f) ensure appropriate exchange of information with interested parties in relation to risks associated with the agri-food chain.
Translation (en-hr): (f) osiguravanje primjerene razmjene informacija sa zainteresiranim stranama u pogledu rizika povezanih s poljoprivredno-prehrambenim lancem.
English: The notification obligation under paragraph 1, also applies to Union laboratories carrying out those studies.
Translation (en-hr): Obveza obavješćivanja iz stavka 1. odnosi se i na laboratorije u Uniji koji provode te studije.
English: Member States that provide the EFSA with expertise also need to receive more compensation.
Translation (en-hr): Države članice koje EFSA-i stavljaju na raspolaganje svoju stručnost usto moraju dobiti veću naknadu.
English: However, the term of office of the members referred to in paragraph 1a(a) and (b) shall not be limited in duration.
Translation (en-hr): Međutim, trajanje mandata članova iz stavka 1.a točaka (a) i (b) nije ograničeno.
English: Its primary mission is to provide scientific advice at the request of the Commission, Member States and the European Parliament and on its own motion.
Translation (en-hr): Njezina je glavna misija pružanje znanstvenih mišljenja na zahtjev Komisije, država članica i Europskog parlamenta ili na vlastitu inicijativu.
English: As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.
Translation (en-hr): Što je prije moguće, a najkasnije u roku od tri mjeseca od dostave, Europski parlament svoja razmatranja dostavlja Vijeću, koje nakon toga imenuje te članove.
English: That section shall be publicly available and easily accessible.
Translation (en-hr): Taj dio mora biti lako dostupan javnosti.
English: "(c) the Authority shall without delay:
Translation (en-hr): „(c) Agencija bez odlaganja mora:
English: Any actions in these areas need to take place at Union level and primarily within the existing Union legislative framework established by the GFL Regulation and in seven other relevant sectoral legislative acts.
Translation (en-hr): Sve aktivnosti u tim područjima moraju se provesti na razini Unije i prvenstveno unutar postojećeg zakonodavnog okvira Unije uspostavljenog Uredbom o općim propisima o hrani i u sedam drugih relevantnih sektorskih zakonodavnih akata.
English: The evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification.
Translation (en-hr): Evaluacija je usmjerena na moguću potrebu za izmjenom mandata Agencije te na financijske učinke takve izmjene.
English: Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications.
Translation (en-hr): Podnositelji zahtjeva, a posebno mala i srednja poduzeća, ponekad ne razumiju dobro te specifikacije.
English: (d) foster public understanding of the risk analysis process so as to enhance confidence in its outcome;
Translation (en-hr): (d) poticanje razumijevanja procesa analize rizika u javnosti kako bi se pojačalo povjerenje u njezin ishod;
English: This is also partly due to the different transparency and confidentiality rules that are laid down not only in Regulation (EC) No 178/2002 but also in other Union legislative acts covering the agri-food chain.
Translation (en-hr): To je djelomično posljedica različitih propisa o transparentnosti i povjerljivosti utvrđenih ne samo Uredbom (EZ) br. 178/2002 nego i u drugim zakonodavnim aktima Unije koji se odnose na poljoprivredno-prehrambeni lanac.
English: [41: OJ L 123, 12.5.2016, p.
Translation (en-hr): [41: SL L 123, 12.5.2016., str. 1.]
English: (a) Where urgent action is essential to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; and,
Translation (en-hr): (a) ako je hitno djelovanje neophodno da bi se zaštitilo zdravlje ljudi, zdravlje životinja ili okoliš, primjerice u kriznim situacijama, Agencija može otkriti informacije iz stavaka 2. i 3.; i
English: Estimate to be expressed in full amounts (or at most to one decimal place)
Translation (en-hr): Procjenu navesti u cijelom iznosu (ili najviše do jednog decimalnog mjesta)
English: Those items referred to in the first subparagraph shall be made public on a dedicated section of the Authority's website.
Translation (en-hr): Točke iz prvog podstavka objavljuju se u posebnom dijelu internetske stranice Agencije.
English: "The number of members in each Scientific Panel within the maximum provided for in paragraph 5g.
Translation (en-hr): „Broj članova znanstvenih panela unutar maksimuma utvrđenog u stavku 5.g.";
English: Actions and total No FTEs Details Details 2020 Million 2021 Million 2022 Million
Translation (en-hr): Aktivnosti i ukupan br. EPRV-a Pojedinosti Pojedinosti 2020 milijuna 2021 milijun 2022 milijuna
English: (a) promote awareness and understanding of the specific issues under consideration during the entire risk analysis process;
Translation (en-hr): (a) promicanje svijesti i razumijevanja o konkretnim pitanjima koja su predmet razmatranja tijekom cijelog procesa analize rizika;
English: It ensures that action can be taken at Union level where there are exceptional circumstances of serious controversies or conflicting results.
Translation (en-hr): Osigurava djelovanje na razini Unije u slučajevima u kojima postoje izvanredne okolnosti kao što su velike kontroverzije ili oprečni rezultati.
English: (38) In order to enable the Authority and the business operators to adapt to the new requirements while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation.
Translation (en-hr): (38) Kako bi se Agenciji i poslovnim subjektima omogućilo da se prilagode tim novim zahtjevima, a istodobno osigurao neometani nastavak rada Agencije, nužno je predvidjeti prijelazne mjere za provedbu ove Uredbe.
English: (c) take into account risk perceptions;
Translation (en-hr): (c) uzimati u obzir predodžbe o rizicima;
English: At the same time, the proposal is expected to ensure the long-term sustainability of EFSA's capacity of scientific expertise.
Translation (en-hr): Istodobno se očekuje da će prijedlog osigurati dugoročnu održivost znanstvenog stručnog kapaciteta EFSA-e.
English: To ensure the transparency of this process, the advice of the Authority should be made public.
Translation (en-hr): Kako bi se osigurala transparentnost tog procesa, savjete Agencije trebalo bi objavljivati.
English: X Proposal/initiative of unlimited duration
Translation (en-hr): X Prijedlog/inicijativa neograničenog trajanja
English: Furthermore, the EFSA staff will provide the advice without the involvement of the Scientific Panels.
Translation (en-hr): Nadalje, osoblje EFSA-e pružit će mišljenja bez uključivanja znanstvenih panela.
English: (d) facilitate understanding and dialogue amongst all interested parties; and,
Translation (en-hr): (d) olakšavati razumijevanje i dijalog među svim zainteresiranim stranama; i
English: Member States shall ensure that the members of the Scientific Panels have the means to dedicate the necessary time and effort to contribute to the work of the Authority.
Translation (en-hr): Države članice osiguravaju da članovi znanstvenih panela imaju sredstva kako bi mogli uložiti potrebno vrijeme i trud i pridonijeti radu Agencije.
English: Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY
Translation (en-hr): Prijedlog/inicijativa na snazi od [DD/MM]GGGG do [DD/MM]GGGG