qanastek/ELRC-Medical-V2 huggingface dataset:
English: 2) It will help to improve citizens' confidence in the credibility of scientific studies and consequently confidence in the Union risk assessment system.
Translation (en-sl): 2) Predlog bo pomagal izboljšati zaupanje državljanov v verodostojnost znanstvenih študij in posledično v sistem Unije za ocenjevanje tveganja.
English: Other simplification aspects include the harmonisation of the confidentiality rules across different sectors providing a similar baseline to all industry applicants in terms of predictability.
Translation (en-sl): Drugi vidiki poenostavitve vključujejo uskladitev pravil o zaupnosti v različnih sektorjih, kar vsem vlagateljem iz industrije omogoča podobno izhodišče v smislu predvidljivosti.
English: Many stakeholders and citizens complain that the EFSA's evaluations of authorisation applications are essentially based on studies, data and information generated (and paid for) by the applicant for authorisation.
Translation (en-sl): Številne zainteresirane strani in državljani se pritožujejo, da ocene vlog za odobritev, ki jih opravi agencija EFSA, v bistvu temeljijo na študijah, podatkih in informacijah, ki jih je pripravil (in plačal) vlagatelj vloge za odobritev.
English: The proposal respects the needs of EFSA for independence, excellence and multi-disciplinary expertise.
Translation (en-sl): Predlog upošteva potrebe agencije EFSA po neodvisnosti, odličnosti in večdisciplinarnem strokovnem znanju.
English: "Where environmental information is concerned, Articles 6 and Article 7 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council shall also apply.
Translation (en-sl): „Kadar gre za okoljske informacije, se uporabljata tudi člena 6 in 7 Uredbe (ES) št. 1367/2006 Evropskega parlamenta in Sveta.
English: (b) promote consistency and transparency in formulating risk management recommendations;
Translation (en-sl): (b) spodbujanje doslednosti in preglednosti pri oblikovanju priporočil za obvladovanje tveganja;
English: [23: https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf.]
Translation (en-sl): [23: https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_sl.pdf.]
English: Those items referred to in the first subparagraph shall be made public on a dedicated section of the Authority's website.
Translation (en-sl): Dokumenti iz prvega pododstavka se objavijo na posebnem razdelku spletišča agencije.
English: Its mandate is broad and covers all issues impacting directly or indirectly on food and feed safety (including the evaluation of dossiers put forward for the approval of substances), animal health and animal welfare, plant health, human nutrition, and GMO issues.
Translation (en-sl): Njena pooblastila so široka in zajemajo vsa vprašanja, ki neposredno ali posredno vplivajo na varnost živil in krme (vključno z oceno dokumentacije za odobritev snovi), zdravje in dobrobit živali, zdravje rastlin, prehrano ljudi in vprašanja na področju gensko spremenjenih organizmov.
English: Union Register of Studies
Translation (en-sl): Register študij Unije
English: Implementation plans and monitoring, evaluation and reporting arrangements
Translation (en-sl): Načrti za izvedbo ter ureditev spremljanja, ocenjevanja in poročanja
English: It is therefore necessary to strengthen the support provided by the Authority and the Member States to the work of the Authority's Scientific Panels.
Translation (en-sl): Zato je treba okrepiti podporo, ki jo Agencija in države članice zagotavljajo za delo znanstvenih svetov Agencije.
English: The powers to adopt delegated acts referred to in Article 8(c) shall be conferred upon the Commission for an indeterminate period of time from [date of entry into force of this Regulation].
Translation (en-sl): Pooblastilo za sprejemanje delegiranih aktov iz člena 8c se prenese na Komisijo za nedoločen čas od [datum začetka veljavnosti te uredbe].
English: - decisions, agreements and contracts resulting from the financing implementing activities of the Regulation will expressly entitle the Commission/EFSA, including OLAF, and the Court of Auditors to conduct audits, on-the-spot checks and inspections;
Translation (en-sl): - v sklepih, sporazumih in pogodbah, ki izhajajo iz dejavnosti izvajanja financiranja iz Uredbe, bosta Komisija/EFSA, vključno z uradom OLAF, in Računsko sodišče izrecno pooblaščena za izvajanje revizij, pregledov na kraju samem in inšpekcijskih pregledov;
English: EFSA's evaluations of authorisation applications are essentially based on industry studies (burden of proof of safety of products on the applicant) also perceived as non-transparent by civil society.
Translation (en-sl): Ocene agencije EFSA v zvezi z vlogami za odobritev v glavnem temeljijo na študijah industrije (dokazno breme o varnosti izdelkov nosi vlagatelj), ki jih civilna družba prav tako dojema kot nepregledne.
English: 3 17.03 11 European Food Safety Authority Diff.
Translation (en-sl): 3 17.03 11 Evropska agencija za varnost hrane dif. DA NE NE NE
English: This means taking into account the general objectives of the GFL Regulation, namely a high level of protection of human health and consumers' interests and the effective functioning of the internal market.
Translation (en-sl): To pomeni, da se upoštevajo splošni cilji uredbe o splošni živilski zakonodaji, torej visoka raven varovanja zdravja ljudi in interesov potrošnikov ter učinkovito delovanje notranjega trga.
English: Information requested to be treated as confidential in the confidential version shall be clearly marked.
Translation (en-sl): Informacije, ki jih je treba obravnavati kot zaupne, morajo biti v zaupni različici jasno označene.
English: It is thus appropriate to include representatives of all Member States in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment.
Translation (en-sl): Zato je v upravni odbor Agencije primerno vključiti predstavnike vseh držav članic, hkrati pa zagotoviti, da imajo navedeni predstavniki izkušnje zlasti na področju ocenjevanja tveganja.
English: DG SANTE actively monitors the compliance of agencies' independence policies with the Commission's guidelines on independence through a DG SANTE's task force including all SANTE's agencies and through bilateral contacts.
Translation (en-sl): GD SANTE dejavno spremlja skladnost politik neodvisnosti v agencijah s smernicami Komisije o neodvisnosti prek svoje projektne skupine, ki vključuje vse agencije GD SANTE, in prek dvostranskih odnosov.
English: To ensure the transparency of this process, the advice of the Authority should be made public.
Translation (en-sl): Za preglednost tega postopka bi bilo treba nasvet Agencije objaviti.
English: As risks due to an important exposure to potential conflicts of interest in EU decentralised agencies and Scientific Committees are assessed as significant (see DG SANTE's 2017 MP), DG SANTE's planned actions focus on improving the handling of conflict of interest situations.
Translation (en-sl): Ker so tveganja zaradi velike izpostavljenosti morebitnim nasprotjem interesov v decentraliziranih agencijah EU in znanstvenih odborih ocenjena kot pomembna (glej načrt upravljanja 2017 GD SANTE), so predvideni ukrepi GD SANTE usmerjeni v izboljšanje obravnavanja primerov nasprotij interesov.
English: The risk of this tool being disproportionally used to unnecessarily commission studies is limited: it is to be triggered by the Commission since it will be financed by the Union budget and only in exceptional circumstances.
Translation (en-sl): Tveganje, da bi se to orodje nesorazmerno uporabljalo za nepotrebno naročanje študij, je omejeno: ker se financira iz proračuna Unije, ga lahko uporabi Komisija in samo v izjemnih okoliščinah.
English: The Executive Director shall submit the list to the Management Board for appointment.
Translation (en-sl): Izvršni direktor predloži seznam upravnemu odboru v imenovanje.
English: A number of impacts were however considered during the preparation process as follows:
Translation (en-sl): Kljub temu pa so bili pri pripravi upoštevani številni učinki:
English: Globally, all these measures will also contribute to an increased involvement of stakeholders in the risk assessment system and thus to a more effective risk communication.
Translation (en-sl): Skupaj bodo vsi ti ukrepi prispevali tudi k večji vključenosti zainteresiranih strani v sistem ocenjevanja tveganja in s tem k učinkovitejšemu obveščanju o tveganju.
English: The provisions of this Regulation shall not apply to applications for authorisations under Union food law as well as requests for scientific outputs submitted to the Authority prior to [general date of entry of application:18 months after its entry into force].
Translation (en-sl): Določbe te uredbe se ne uporabljajo za vloge za odobritev na podlagi živilske zakonodaje Unije niti za zaprosila za znanstvene prispevke, predložene Agenciji pred [splošni datum začetka uporabe: 18 mesecev po začetku njene veljavnosti].
English: The challenges to be addressed related to transparency, sustainability of the EU risk assessment system (which for authorisations of products/substances is an EU centralised system, with the exception of pesticides dual system) and the demand for risk communication to be more effective.
Translation (en-sl): Izzivi, ki jih je treba obravnavati v zvezi s preglednostjo in trajnostjo sistema EU za ocenjevanje tveganja (ki je za odobritve izdelkov/snovi centraliziran sistem EU, z izjemo dvojnega sistema za pesticide) ter potrebo po učinkovitejšem obveščanju o tveganju.
English: (33) Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to provide for a Commission evaluation of the Authority, in accordance with the Common Approach on Decentralised Agencies.
Translation (en-sl): (33) Poleg tega je za oceno uspešnosti in učinkovitosti različnih določb, ki se uporabljajo za Agencijo, primerno tudi določiti, da Komisija oceni Agencijo, in sicer v skladu s skupnim pristopom k decentraliziranim agencijam.
English: In parallel to the legislative measures, the Commission will also continue to provide support to food safety via its Research and Innovation policies and contribute to strengthening coordination, cooperation and cohesion of food safety research and innovation activities in the Union and its Member States in particular when building the forthcoming ninth European Research and Innovation Framework Programme.
Translation (en-sl): Vzporedno z zakonodajnimi ukrepi bo Komisija s svojimi politikami na področju raziskav in inovacij še naprej zagotavljala podporo varnosti hrane ter prispevala h krepitvi usklajevanja, sodelovanja in kohezije raziskovalnih in inovacijskih dejavnosti na področju varnosti hrane v Uniji in njenih državah članicah, zlasti pri oblikovanju prihodnjega devetega evropskega okvirnega programa za raziskave in inovacije.
English: (b) the names of authors of published, or publicly available, studies supporting such requests; and
Translation (en-sl): (b) imena avtorjev objavljenih ali javno dostopnih študij v podporo takim zaprosilom ter
English: The proposal/initiative relates to a new action following a pilot project/preparatory action
Translation (en-sl): Predlog/pobuda se nanaša na nov ukrep na podlagi pilotnega projekta/ pripravljalnega ukrepa.
English: The application provided for in Article 14 of this Regulation shall be submitted by a producer of the active substance to a Member State, with a copy to the other Member States, the Commission and the Authority, no later than three years before the expiry of the approval.
Translation (en-sl): Zahtevek iz člena 14 te uredbe predloži proizvajalec aktivne snovi državi članici, pri čemer pošlje po en izvod drugim državam članicam, Komisiji in Agenciji, in sicer najpozneje tri leta pred iztekom odobritve.
English: (d) foster public understanding of the risk analysis process so as to enhance confidence in its outcome;
Translation (en-sl): (d) povečanje razumevanja postopka analize tveganja v javnosti, da se poveča zaupanje v njegove rezultate;
English: Estimated requirements of human resources for the parent DG
Translation (en-sl): Ocenjene potrebe po človeških virih za matični GD
English: Since some specific changes of EFSA's functioning (pre-submission advice, composition of the Panels) are proposed, care has been taken to take into account procedures followed by other scientific agencies with special attention to European Chemicals Agency (ECHA) and European Medicines Agency (EMA).
Translation (en-sl): Ker so predlagane nekatere specifične spremembe v delovanju agencije EFSA (svetovanje pred vložitvijo vloge, sestava svetov), je bila pozornost namenjena upoštevanju postopkov drugih znanstvenih agencij, zlasti Evropske agencije za kemikalije (ECHA) in Evropske agencija za zdravila (EMA).
English: This proposal is addressing those challenges directly linked to the GFL Regulation and EFSA.
Translation (en-sl): Ta predlog obravnava te izzive, ki so neposredno povezani z uredbo o splošni živilski zakonodaji in agencijo EFSA.
English: The Management Board shall adopt, on the basis of a proposal of the Executive Director, rules on the detailed organisation and timing of the procedures set up in paragraphs 5a and 5b of the present Article.
Translation (en-sl): Upravni odbor na predlog izvršnega direktorja sprejme pravila za podrobno organizacijo in časovni načrt postopkov iz odstavkov 5a in 5b tega člena.
English: The assessment of the impacts outlines how the proposal achieves the best balance in meeting the objectives laid out by the initiative, ensuring benefits for citizens, stakeholders and Member States, while not significantly impacting on industry and innovation.
Translation (en-sl): V oceni učinkov je opisano, kako se s predlogom najbolj uravnoteženo dosegajo cilji pobude, prinašajo koristi za državljane, zainteresirane strani in države članice, ne da bi predlog bistveno vplival na industrijo in inovacije.
English: (c) provide a sound basis for understanding risk management decisions;
Translation (en-sl): (c) zagotavljanje trdne podlage za razumevanje odločitev glede obvladovanja tveganja;
English: The notification of commissioned studies creates a minimal burden.
Translation (en-sl): Obveščanje o naročenih študijah pomeni minimalno breme.
English: It has made major progress on increasing its scientific capacity of expertise, boosting the quality of its scientific outputs, expanding its collection of scientific data and developing and harmonising risk assessment methodologies.
Translation (en-sl): Agencija je dosegla velik napredek pri krepitvi znanstvenega strokovnega znanja, izboljšanju kakovosti svojih znanstvenih prispevkov, razširitvi svoje zbirke znanstvenih podatkov ter razvoju in usklajevanju metodologij za oceno tveganja.
English: The use of the detection methods and the reproduction of the reference materials, provided under Article 5(3) and 17(3) for the purpose of applying this Regulation to the GMOs, food or feed to which an application refers, shall not be restricted by the exercise of intellectual property rights or otherwise."
Translation (en-sl): Uporaba postopkov odkrivanja in razmnoževanje referenčnega materiala iz členov 5(3) in 17(3) za namene uporabe te uredbe za GSO, živila ali krmo, na katere se nanaša vloga, nista omejena z uveljavljanjem pravic intelektualne lastnine ali kako drugače."
English: (3) commercial information revealing sourcing, market shares or business strategy of the applicant; and,
Translation (en-sl): (3) poslovnih informacij, ki razkrivajo vire, tržne deleže ali poslovno strategijo vlagatelja ter
English: This risk is also addressed by the better financial compensation of Member States contributing to EFSA's work by sending experts or providing preparatory work.
Translation (en-sl): Za obravnavanje tega tveganja so predvidena tudi boljša finančna nadomestila za države članice, ki prispevajo k delu agencije EFSA z napotitvijo strokovnjakov ali pripravljalnim delom.
English: The system has thus to be strengthened and Member States should take a more active role to ensure that a sufficient pool of experts is available to meet the needs of the Union risk assessment system in terms of high level of scientific expertise, independence and multidisciplinary expertise.
Translation (en-sl): Sistem je zato treba okrepiti, države članice pa bi morale imeti aktivnejšo vlogo pri zagotavljanju zadostnega nabora strokovnjakov za izpolnjevanje potreb sistema Unije za ocenjevanje tveganja v smislu visoke ravni strokovnega znanja, neodvisnosti in večdisciplinarnega strokovnega znanja.
English: Please note that inflation adjustments to the figures mentioned in the tables below, need to be considered as from the year 2023 onwards.
Translation (en-sl): Za obdobje od leta 2023 naprej je treba pri številkah iz naslednjih tabel upoštevati inflacijske prilagoditve.
English: (b) results of production batches of the active substance including impurities; and,
Translation (en-sl): (b) rezultatov proizvodnih serij aktivne snovi, vključno z nečistočami; ter
English: Given the problems identified above, the purpose of this Regulation is to introduce changes to the existing legal framework which are limited to what is strictly necessary to achieve the objectives set up for the initiative in order to improve citizen and stakeholder confidence in the transparency and sustainability of the Union approach towards food safety, notably in relation to risk assessment.
Translation (en-sl): Glede na zgoraj navedene težave je namen te uredbe uvesti spremembe v sedanji pravni okvir, ki so omejene na to, kar je nujno potrebno za doseganje ciljev iz pobude, da bi se povečalo zaupanje državljanov in zainteresiranih strani v preglednost in trajnost pristopa Unije k varnosti hrane, zlasti v zvezi z oceno tveganja.
English: Accordingly, no personal data should be made publicly available under this Regulation, unless it is necessary and proportionate for the purposes of ensuring the transparency, independence and the reliability of the risk assessment process, while preventing conflicts of interests.
Translation (en-sl): Zato v skladu s to uredbo nobeni osebni podatki ne bi smeli biti javno dostopni, razen če je to potrebno in sorazmerno za namene zagotavljanja preglednosti, neodvisnosti in zanesljivosti postopka ocenjevanja tveganja, pri čemer pa se preprečuje nasprotje interesov.
English: Such obligations avoid the unnecessary repetition of studies on vertebrates and enlarge the evidence base of EFSA, without jeopardising the competitiveness of the relevant applicant.
Translation (en-sl): S takimi obveznostmi se prepreči nepotrebno ponavljanje študij na vretenčarjih in razširi dokazna podlaga za agencijo EFSA, ne da bi bila pri tem ogrožena konkurenčnost zadevnega vlagatelja.
English: Transitional measures
Translation (en-sl): Prehodni ukrepi
English: This principle remains valid, but the concerns on the transparency and independence of industry-generated studies and data should be addressed.
Translation (en-sl): To načelo še vedno velja, vendar pa bi se morali obravnavati pomisleki glede preglednosti in neodvisnosti študij in podatkov, ki jih pripravi industrija.
English: (7) Based on these general objectives and principles, a general plan on risk communication should be established in close cooperation with the Authority and the Member States, and following relevant public consultations.
Translation (en-sl): (7) Na podlagi teh splošnih ciljev in načel bi bilo treba vzpostaviti splošni načrt obveščanja o tveganju v tesnem sodelovanju z Agencijo in državami članicami, po ustreznih javnih posvetovanjih.
English: (2) commercial links between a producer or importer and the applicant or the authorisation holder, where applicable;
Translation (en-sl): (2) trgovinskih povezav med proizvajalcem ali uvoznikom in vlagateljem ali, kjer je primerno, imetnikom odobritve;
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-sl): Poleg tega se javna sredstva ne bi smela uporabljati za naročanje dragih študij (v vrednosti več tisoč do več milijonov evrov), ki bodo na koncu industriji pomagale dati izdelek na trg.
English: It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.
Translation (en-sl): Zlasti je pomembno, da se Komisija pri svojem pripravljalnem delu ustrezno posvetuje, tudi s strokovnjaki, in da se ta posvetovanja izvajajo v skladu z načeli iz Medinstitucionalnega sporazuma o boljši pripravi zakonodaje z dne 13. aprila 2016.
English: Member States were consulted in a meeting of the Expert Group on the General Food Law on 5 March 2018.
Translation (en-sl): Posvetovanje z državami članicami je potekalo 5. marca 2018 na sestanku strokovne skupine o splošni živilski zakonodaji.
English: SPECIFIC OBJECTIVE No 1 improve and clarify the rules on transparency, especially with regard to the scientific studies supporting the risk assessment[48: As described in point 1.4.2.
Translation (en-sl): SPECIFIČNI CILJ št. 1 izboljšati in pojasniti pravila o preglednosti, zlasti glede znanstvenih študij v podporo oceni tveganja[48: Kakor je opisan v točki 1.4.2 „Specifični cilji".]
English: 2) increase reliability, objectivity and independence of studies
Translation (en-sl): 2) Povečati zanesljivost, objektivnost in neodvisnost študij
English: This in turn is expected to have a positive impact on the sustainability of the Union risk assessment system.
Translation (en-sl): To naj bi imelo pozitiven učinek na vzdržnost sistema Unije za ocenjevanje tveganja.
English: Human Resources
Translation (en-sl): Človeški viri
English: To guarantee maintenance of a high level of scientific expertise in EFSA and its risk assessment capacity to ensure the sustainability of the Union risk assessment system that is the basis of all measures taken on food safety.
Translation (en-sl): Zagotovitev ohranjanja visoke ravni strokovnega znanja v agenciji EFSA in njene zmogljivosti za ocenjevanje tveganja za trajnost sistema Unije za ocenjevanje tveganja, ki je podlaga za vse ukrepe, sprejete na področju varnosti hrane.
English: Decisions taken by the Authority pursuant to this Article may be subject to an action before the Court of Justice of the European Union, under the conditions laid down in Articles 263 and 278 of the Treaty respectively.
Translation (en-sl): Zoper odločitve, ki jih agencija sprejme v skladu s tem členom, se lahko vloži tožba pred Sodiščem Evropske unije pod pogoji, določenimi v členu 263 oziroma členu 278 Pogodbe.
English: Enhanced transparency is expected to contribute to strengthening a climate of consumers' confidence that is beneficial for stimulating innovation and for the Union product safety recognition worldwide.
Translation (en-sl): Večja preglednost naj bi prispevala h krepitvi ozračja zaupanja potrošnikov, ki je ugodno za spodbujanje inovacij in za mednarodno priznavanje varnosti proizvodov v Uniji.
English: 1) The proposal ensures that scientists and citizens have access to key safety related information being assessed by EFSA at an early stage of the risk assessment.
Translation (en-sl): 1) Predlog znanstvenikom in državljanom zagotavlja dostop do ključnih informacij, povezanih z varnostjo, ki jih ocenjuje EFSA na začetni stopnji ocene tveganja.
English: The studies commissioned may have a wider scope than the evidence subject to verification.
Translation (en-sl): Naročene študije so lahko obširnejše kot dokaz, ki se preverja.