qanastek/ELRC-Medical-V2 huggingface dataset:
English: The lack of legal basis to audit the monitoring authorities of non-European Union countries is dealt with by coordinating activities with the Member States and OECD GLP programmes and by seeking to conclude bilateral international agreements.
Translation (en-sl): Zaradi odsotnosti pravne podlage za presojo nadzornih organov držav nečlanic EU se usklajujejo dejavnosti med državami članicami in programi OECD za dobro laboratorijsko prakso, potekajo pa tudi prizadevanja za sklenitev dvostranskih mednarodnih sporazumov.
English: As confirmed in the recently published Fitness Check of the GFL Regulation (GFL Fitness Check), the rigorous implementation of the risk analysis principle throughout the Union law has overall raised the level of protection from potential food safety risks in a number of ways.
Translation (en-sl): Kot je bilo potrjeno v nedavno objavljenem preverjanju ustreznosti uredbe o splošni živilski zakonodaji, se je zaradi strogega izvajanja načela analize tveganja v celotnem pravu Unije na splošno povečala stopnja zaščite pred potencialnimi tveganji v zvezi z varnostjo hrane, in sicer na več načinov.
English: Auditing by the European Commission: This will strengthen the guarantees on the quality of the studies EFSA takes into consideration in its risk assessments, in particular with regard to the reproducibility of results.
Translation (en-sl): Presoje, ki jih izvaja Evropska komisija: Z njimi se bodo okrepila jamstva za kakovost študij, ki jih EFSA upošteva pri svojih ocenah tveganja, zlasti v zvezi s ponovljivostjo rezultatov.
English: Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should be responsible for triggering the commissioning of such verification studies.
Translation (en-sl): Ker bi se tako izjemno orodje za preverjanje financiralo iz proračuna Unije in ker bi morala njegova uporaba ostati sorazmerna, bi morala biti za naročila takih preveritvenih študij odgovorna Komisija.
English: "(c) The Authority shall:
Translation (en-sl): „(c) Agencija:
English: Strengthen advocacy: targeted messages, narrative, translations etc 4.8 FTEs 0.248 0.434 0.620
Translation (en-sl): Krepitev zagovorništva: ciljna sporočila, predstavitve, prevodi itd. 4,8 EPDČ 0,248 0,434 0,620
English: Heading of multiannual financial
Translation (en-sl): Razdelek večletnega finančnega
English: (d) the information on which its scientific outputs, including scientific opinions are based, taking into account protection of confidential data and protection of personal data in accordance with Articles 39 to 39f;
Translation (en-sl): (d) informacije, na katerih temeljijo njeni znanstveni prispevki, vključno z znanstvenimi mnenji, pri čemer upošteva varstvo zaupnih podatkov in varstvo osebnih podatkov v skladu s členi 39 do 39f;
English: The proposal at hand provides for a periodic overall evaluation of the agency, to be commissioned by the Commission, as per the Common Approach on Decentralised Agencies.
Translation (en-sl): Ta predlog določa redno splošno oceno agencije, ki jo naroči Komisija na podlagi skupnega pristopa k decentraliziranim agencijam.
English: The non-confidential version shall be without the information the applicant deems confidential in accordance with paragraphs 2 and 3 of Article 39.
Translation (en-sl): Nezaupna različica ne vsebuje informacij, ki jih vlagatelj v skladu z odstavkoma 2 in 3 člena 39 šteje za zaupne.
English: It also attaches continuous importance to the quality and independence of scientific studies that are the basis of the EU risk assessment carried out by EFSA".
Translation (en-sl): Prav tako pripisuje stalno pomembnost kakovosti in neodvisnosti znanstvenih študij, na katerih temelji ocenjevanje tveganja na ravni EU, ki ga izvaja EFSA.
English: Decision on confidentiality
Translation (en-sl): Odločitev o zaupnosti
English: The applicant shall clearly indicate the grounds on the basis of which confidentiality is requested for the different pieces of information.
Translation (en-sl): Vlagatelj jasno navede razloge, zaradi katerih zahteva zaupnost posameznih informacij.
English: The Commission will bear the limited costs.
Translation (en-sl): Stroški so omejeni, krila pa jih bo Komisija.
English: Information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparency.
Translation (en-sl): Informacije o priglašenih študijah bi bilo treba objaviti šele po objavi ustrezne vloge za odobritev v skladu z veljavnimi pravili o preglednosti.
English: tighten and clarify the rules on transparency, especially with regard to the scientific studies used as the basis for risk assessment the EFSA carries out;
Translation (en-sl): poostritve in pojasnitve pravil o preglednosti, zlasti glede znanstvenih študij, uporabljenih kot podlaga za oceno tveganja, ki jo opravi EFSA;
English: To increase the effectiveness of the consultation, the consultation should take place when the studies submitted by industry included in an application for authorisation are made public, under the transparency rules of this Regulation.
Translation (en-sl): Da bi povečali učinkovitost posvetovanja, bi to moralo potekati po objavi študij iz vloge za odobritev, ki jih je predložila industrija, v skladu s pravili o preglednosti iz te uredbe.
English: This principle is based on the premise that public health is better protected when the burden is on the applicant to prove that a particular food or feed is safe prior to its placing on the market, instead of the public authorities having to prove that it is unsafe.
Translation (en-sl): To načelo temelji na predpostavki, da se javno zdravje bolje varuje, če mora vlagatelj dokazati, da je določeno živilo ali krma varna, preden se da na trg, ne pa da morajo javni organi dokazovati, da proizvod ni varen.
English: The impact on the timing of authorisation is minimal since the notification of commissioned studies takes place at the pre-submission stage and the risk assessment will run in parallel of the consultation on submitted studies
Translation (en-sl): Učinek na časovni potek odobritve je zelo majhen, saj obveščanje o naročenih študijah poteka pred vložitvijo vloge, ocena tveganja pa bo opravljena hkrati s posvetovanjem o predloženih študijah.
English: Before the Authority issues its scientific outputs, including scientific opinions, it shall review whether information that has been previously accepted as confidential may nevertheless be made public in accordance with paragraph 4(b) of Article 39.
Translation (en-sl): Preden agencija izda svoje znanstvene prispevke, vključno z znanstvenimi mnenji, preuči, ali se lahko informacije, za katere je bila pred tem odobrena zaupna obravnava, vseeno objavijo v skladu z odstavkom 4(b) člena 39.
English: The proposal will provide for a series of measures to ensure that EFSA has access to the broadest relevant scientific evidence possible related to a request for authorisation and to increase the guarantees of reliability, objectivity and independence of studies used by EFSA in its risk assessment.
Translation (en-sl): Predlog bo določal vrsto ukrepov, s katerimi se bo agenciji EFSA zagotovil dostop do čim obsežnejših relevantnih znanstvenih dokazov v zvezi z vlogo za odobritev in s katerimi se bodo povečala jamstva glede zanesljivosti, objektivnosti in neodvisnosti študij, ki jih EFSA uporabi v svojih ocenah tveganja.
English: In particular, the Executive Director, whose function is to defend EFSA's independent point of view and interests, selects the experts proposed for appointment to the Management Board from the large pool of experts nominated by Member States.
Translation (en-sl): Izvršni direktor, katerega naloga je zaščititi neodvisnost in interese agencije EFSA, izbere strokovnjake, ki jih je za imenovanje predlagal upravni odbor izmed velikega števila strokovnjakov, ki so jih predlagale države članice.
English: In drafting the proposal, contributions have been taken into account for measures in four specific areas: the publication of studies supporting industry applications of regulated products while protecting confidential and personal data; guarantees in the Union to verify the reliability, and independence of the evidence taken from industry studies; making risk communication more efficient; and strengthening EFSA's sustainability and governance while ensuring the independence and excellence of the expertise made available to the Authority by the Union Member States.
Translation (en-sl): Pri pripravi predloga so bili upoštevani prispevki za ukrepe na štirih posebnih področjih: objava študij v podporo vlogam industrije za regulirane proizvode, pri čemer se zagotavlja varstvo zaupnih in osebnih podatkov; jamstva v Uniji za preverjanje zanesljivosti in neodvisnosti dokazov iz študij industrije; učinkovitejše obveščanje o tveganju ter krepitev vzdržnosti in upravljanja agencije EFSA ob hkratnem zagotavljanju neodvisnosti in odličnosti strokovnega znanja, ki ga dajo agenciji na voljo države članice Unije.
English: (d) Where standard data formats and software packages have been adopted pursuant to this article, applications as well as requests for a scientific output, including a scientific opinion by the European Parliament, the Commission and the Member States under Union food law, shall only be submitted in accordance with the standard data formats and software packages laid down in those acts.
Translation (en-sl): (d) Kadar so bili v skladu s tem členom sprejeti standardne oblike zapisa podatkov in paketi programske opreme, se vloge in zaprosila za znanstvene prispevke, vključno z zaprosili Evropskega parlamenta, Komisije in držav članic za znanstveno mnenje na podlagi živilske zakonodaje Unije, predložijo le v skladu s standardnimi oblikami zapisa podatkov in paketi programske opreme, ki so določeni v navedenih aktih.
English: (c) scientific data, studies and other information supporting applications for authorisation under Union food law, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific output, including a scientific opinion, taking into account protection of confidential information and protection of personal data in accordance with Articles 39 to 39f.
Translation (en-sl): (c) znanstvene podatke, študije in druge informacije v podporo vlogam za odobritev na podlagi živilske zakonodaje Unije, vključno z dodatnimi informacijami, ki so jih predložili vlagatelji, ter druge znanstvene podatke in informacije v podporo zaprosilom Evropskega parlamenta, Komisije in držav članic za znanstvene prispevke, vključno z znanstvenim mnenjem, pri čemer upošteva varstvo zaupnih informacij in varstvo osebnih podatkov v skladu s členi 39 do 39f.
English: Amendments to Regulation (EC) No 1829/2003 on genetically modified food and feed
Translation (en-sl): Spremembe Uredbe (ES) št. 1829/2003 o gensko spremenjenih živilih in krmi
English: To improve transparency of studies and address the societal concerns for a more transparent and independent risk assessment process and a more effective risk communication.
Translation (en-sl): Izboljšanje preglednosti študij in obravnavanje družbenih pomislekov za preglednejši in bolj neodvisen postopek ocenjevanja tveganja ter učinkovitejše obveščanje o tveganju.
English: Without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances, may request the Authority to commission scientific studies with the objective of verifying evidence used in its risk assessment process.
Translation (en-sl): Brez poseganja v obveznost vlagateljev vlog za odobritev na podlagi živilske zakonodaje, da dokažejo varnost predmeta, predloženega v sistem odobritve, lahko Komisija v izjemnih okoliščinah od agencije zahteva, da naroči znanstvene študije za preverjanje dokazov, uporabljenih v postopku ocenjevanja tveganja.
English: The Authority shall make available, upon request, to the Commission and the Member States all information in its possession relating to an application for an authorisation or to a request by the European Parliament, the Commission or the Member States for a scientific output, including a scientific opinion, unless otherwise indicated in specific Union food law.
Translation (en-sl): Na zahtevo da Agencija Komisiji in državam članicam na voljo vse informacije, ki jih ima v zvezi z vlogo za odobritev ali zaprosilom Evropskega parlamenta, Komisije ali držav članic za znanstveni prispevek, vključno z znanstvenim mnenjem, razen če je v posebni živilski zakonodaji Unije določeno drugače.
English: The Commission and the Member States shall also take the necessary measures so that information for which confidential treatment has been accepted by the Authority is not made public.
Translation (en-sl): Komisija in države članice sprejmejo tudi potrebne ukrepe, da ne objavijo informacij, za katere je agencija odobrila zaupno obravnavo.
English: (9) Transparency of the risk assessment process contributes to the Authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing its mission, increases their confidence in its work and ensures that the Authority is more accountable to the Union citizens in a democratic system.
Translation (en-sl): (9) Preglednost postopka ocenjevanja tveganja prispeva k temu, da potrošniki in splošna javnost v večji meri priznavajo legitimnost Agencije za izpolnjevanje njenih nalog, povečuje njihovo zaupanje v delo Agencije ter zagotavlja, da je Agencija bolj odgovorna državljanom Unije v demokratičnem sistemu.
English: When submitting an application for an authorisation, supporting scientific data and other supplementary information in accordance with Union food law, the applicant may request certain parts of the information submitted to be kept confidential in accordance with paragraphs 2 and 3 of Article 39.
Translation (en-sl): Ob predložitvi vloge za odobritev, podpornih znanstvenih podatkov in drugih dodatnih informacij v skladu z živilsko zakonodajo Unije lahko vlagatelj zahteva, da se nekatere predložene informacije v skladu z odstavkoma 2 in 3 člena 39 obravnavajo zaupno.
English: It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted, while not entering into the design of the studies to be submitted that remain the applicant's responsibility.
Translation (en-sl): Zato bi bilo primerno, da bi Agencija na zahtevo svetovala morebitnemu vlagatelju o veljavnih pravilih in zahtevani vsebini vloge za odobritev, preden se vloga uradno vloži, ne da bi pri tem obravnavala zasnovo študij, ki jih je treba predložiti, za kar bi bil še naprej odgovoren vlagatelj.
English: Amendments to Regulation (EC) No 1935/2004 on Food Contact Materials
Translation (en-sl): Spremembe Uredbe (ES) št. 1935/2004 o materialih, namenjenih za stik z živili
English: Any personal data made public pursuant to Article 38 and this article shall only be used to ensure the transparency of risk assessment process under this Regulation and not be further processed in a manner that is incompatible with these purposes, in the meaning of Article 5(1)(b) of Regulation (EU) 2016/679 and Article 4(1)(b) of Regulation (EC) No 45/2001, as the case may be.
Translation (en-sl): Vsi osebni podatki, objavljeni v skladu s členom 38 in tem členom, se uporabljajo samo za zagotovitev preglednosti postopka ocenjevanja tveganja na podlagi te uredbe in se ne smejo nadalje obdelovati na način, ki ni združljiv s temi nameni, v smislu člena 5(1)(b) Uredbe (EU) 2016/679 in člena 4(1)(b) Uredbe (ES) št. 45/2001, odvisno od primera.
English: Contract agents Year
Translation (en-sl): Pogodbeni uslužbenci Leto
English: Seconded National Experts Year
Translation (en-sl): Napoteni nacionalni strokovnjaki Leto
English: [13: Proposal for a Regulation of the European Parliament and of the Council adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union, COM(2016)799 final, dated 14.12.2016.]
Translation (en-sl): [13: Predlog uredbe Evropskega parlamenta in Sveta o prilagoditvi številnih zakonodajnih aktov, v katerih je določena uporaba regulativnega postopka s pregledom, členoma 290 in 291 Pogodbe o delovanju Evropske unije, COM(2016) 799 final, z dne 14. 12.
English: The Authority may only accept to provide confidential treatment in relation to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned:
Translation (en-sl): Agencija lahko odobri samo zaupno obravnavo naslednjih informacij, katerih razkritje bi lahko na podlagi preverljive utemeljitve znatno škodovalo zadevnim interesom:
English: IT support for data disclosure Licences/maintenance/storage/security 0.960 1.680 2.400 2.400 2.400 9.840
Translation (en-sl): Informacijska podpora za objavljanje podatkov Licence/vzdrževanje/shranjevanje/varnost 0,960 1,680 2,400 2,400 2,400 9,840
English: (5) Particular emphasis should be placed on explaining in a coherent, appropriate and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors, where relevant.
Translation (en-sl): (5) Posebno pozornost bi bilo treba nameniti skladni, ustrezni in pravočasni razlagi ugotovitev ocene tveganja ter tudi načinov, kako te pripomorejo k odločitvam za obvladovanje tveganja, skupaj z drugimi upoštevanja vrednimi dejavniki, kadar je to ustrezno.
English: The Authority shall apply Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents when handling applications for access to documents held by the Authority.
Translation (en-sl): Agencija pri obravnavanju vlog za dostop do dokumentov, ki jih hrani, uporablja Uredbo Evropskega parlamenta in Sveta (ES) št. 1049/2001 z dne 30. maja 2001 o dostopu javnosti do dokumentov Evropskega parlamenta, Sveta in Komisije.
English: (18) The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law.
Translation (en-sl): (18) Agencija bi morala poznati predmet vseh študij, ki jih izvede vlagatelj v zvezi s prihodnjo vlogo za odobritev na podlagi živilske zakonodaje Unije.
English: 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.
Translation (en-sl): Ob predložitvi zahtevka lahko vlagatelj v skladu s členom 63 zaprosi, da se nekatere informacije in nekateri deli dokumentacije obravnavajo zaupno, ter take informacije fizično loči.
English: Subtotal for specific objective No 4 2.800 4.900 7.000 7.000 7.000 28.700
Translation (en-sl): Seštevek za specifični cilj št. 4 2,800 4,900 7,000 7,000 7,000 28,700
English: (27) To determine what level of disclosure strikes the appropriate balance, the relevant rights of the public to transparency in the risk assessment process, should be weighted up against the rights of commercial applicants, taking into account the objectives of Regulation (EC) No 178/2002.
Translation (en-sl): (27) Za določitev ravni razkritja, ki zagotavlja primerno ravnotežje, bi bilo treba ustrezne pravice javnosti do preglednosti v postopku ocenjevanja tveganja ponderirati glede na pravice poslovnih vlagateljev, ob upoštevanju ciljev Uredbe (ES) št. 178/2002.
English: (c) On the basis of the nominations made by Member States, the Executive Director shall draw for each Scientific Panel a list of experts larger than the number of members to be appointed.
Translation (en-sl): (c) Na podlagi predlogov držav članic izvršni direktor za vsak znanstveni svet pripravi seznam strokovnjakov, ki vključuje več imen, kot je število članov, ki bodo imenovani.
English: "Article 57a
Translation (en-sl): „Člen 57a
English: Taking into account the respective roles of risk assessors and risk managers, risk communication shall:
Translation (en-sl): Ob upoštevanju vlog odgovornih za oceno tveganja in odgovornih za obvladovanje tveganja mora obveščanje o tveganju:
English: The pre-submission procedure ensures an additional involvement of EFSA, to ensure that the applicant is aware of and can adhere to the applicable requirements relating to the content of authorisation applications.
Translation (en-sl): S postopkom pred vložitvijo vloge se zagotavlja dodatna vključenost agencije EFSA, da se zagotovi seznanjenost vlagatelja z veljavnimi zahtevami v zvezi z vsebino vlog za odobritev in njihovo upoštevanje.
English: The main objective of the proposal is to make studies used in risk assessment more transparent and address the demands of society for a more transparent and independent risk assessment process and more effective risk communication.
Translation (en-sl): Glavni cilj predloga je povečati preglednost študij, uporabljenih v oceni tveganja, ter se odzvati na zahteve družbe po bolj preglednem in neodvisnem postopku ocenjevanja tveganja ter učinkovitejšem obveščanju o tveganju.
English: Verification studies
Translation (en-sl): Preveritvene študije
English: Where an applicant submits a request for confidentiality, it shall provide a non-confidential version and a confidential version of the information submitted in accordance with standard data formats, where they exist, pursuant to Article 39f.
Translation (en-sl): Kadar vlagatelj vloži zahtevo za zaupnost, predloži nezaupno in zaupno različico predloženih informacij v standardnih oblikah zapisa podatkov, če te obstajajo, v skladu s členom 39f.
English: (b) Member States shall nominate experts with a view to collectively reach the number indicated by the Executive Director.
Translation (en-sl): (b) Države članice predlagajo strokovnjake, njihovo skupno število pa mora doseči število, ki ga navede izvršni direktor.
English: It is proposed to lay down in legislation the objectives and general principles governing risk communication, taking into account the respective roles of risk assessors and managers pursuant to Article 40 of Regulation (EC) No 178/2002 and, based on these objectives and general principles, to draw up a general plan on risk communication ("general plan").
Translation (en-sl): Predlagano je, da se v zakonodaji določijo cilji in splošna načela za obveščanje o tveganju, ob upoštevanju vlog odgovornih za oceno tveganja in odgovornih za obvladovanje tveganja v skladu s členom 40 Uredbe (ES) št. 178/2002, in da se na podlagi teh ciljev in splošnih načel sestavi splošni načrt obveščanja o tveganju („splošni načrt").
English: If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f.
Translation (en-sl): Če vlagatelj v postopku odobritve umakne vlogo, agencija, Komisija in države članice upoštevajo zaupnost poslovnih in industrijskih informacij, kot jo je odobrila agencija v skladu s členi 39 do 39f.
English: The notified information shall be made public only in case a corresponding application for authorisation has been received and after the Authority has decided on the disclosure of the accompanying studies in accordance with Article 38 and Articles 39 to 39f.
Translation (en-sl): Sporočene informacije se objavijo samo v primeru prejetja ustrezne vloge za odobritev in po tem, ko agencija sprejme odločitev o razkritju spremljajočih študij v skladu s členom 38 in členi 39 do 39f.