qanastek/ELRC-Medical-V2 huggingface dataset:
English: (14) To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels by the Member States, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel.
Translation (en-sl): (14) Da bi ocenjevanje tveganja ostalo neodvisno od obvladovanja tveganja in drugih interesov na ravni Unije, je primerno, da predlog članov znanstvenih svetov s strani držav članic, izbor članov, ki ga opravi izvršni direktor Agencije, in njihovo imenovanje, ki ga opravi upravni odbor Agencije, temeljijo na strogih merilih, ki zagotavljajo odličnost in neodvisnost strokovnjakov in hkrati potrebno večdisciplinarno strokovno znanje vsakega sveta.
English: (a) The Executive Director, after consulting the Management Board, shall send to the Member States the request for the specific multidisciplinary expertise needed in each Scientific Panel and shall indicate the number of experts to be nominated by the Member States.
Translation (en-sl): (a) Izvršni direktor po posvetovanju z upravnim odborom pošlje državam članicam zaprosilo za posebna večdisciplinarna strokovna znanja, potrebna v posameznem znanstvenem svetu, ter navede število strokovnjakov, ki jih morajo predlagati države članice.
English: There is no risk of public authorities becoming responsible for providing evidence on the safety of substance for EFSA's assessment, since the principle that it is the responsibility of the industry (applicants) to provide such evidence during the risk assessment process remains.
Translation (en-sl): Ni tveganja, da bi se odgovornost za predložitev dokazov o varnosti snovi za namen njene ocene, ki jo pripravi EFSA, prenesla na javne organe, saj se ohrani načelo, da je industrija (vlagatelji) odgovorna za predložitev takih dokazov v postopku ocenjevanja tveganja.
English: Member States shall launch a call for interest as a basis for their nominations.
Translation (en-sl): Države članice objavijo razpis za prijavo interesa, na podlagi katerega predlagajo svoje kandidate.
English: As for other agencies, EFSA independence is appropriately safeguarded by the criteria for nomination that privilege members with a profile of risk assessor and the strong provisions on independence and on transparency since the rules providing that the members of the Management Board have to act independently in the public interest and make an annual public declaration of interests remain unchanged.
Translation (en-sl): Kot pri drugih agencijah je tudi neodvisnost agencije EFSA ustrezno zaščitena z merili za imenovanje, ki dajejo prednost članom s profilom odgovornega za oceno tveganja, ter s strogimi določbami o neodvisnosti in preglednosti, saj ostajajo pravila, ki določajo, da morajo člani upravnega odbora delovati neodvisno in v javnem interesu ter vsako leto podati javno izjavo o interesih, nespremenjena.
English: (a) any information provided in detailed descriptions of starting substances and preparations used to manufacture the substance subject to the authorisation, the composition of preparations, materials or articles in which the applicant intends to use this substance, the manufacturing methods of these preparations, materials or articles, impurities, and migration testing results;
Translation (en-sl): (a) vseh informacij, predloženih v podrobnih opisih izhodnih snovi in pripravkov, ki se uporabljajo za proizvodnjo snovi, ki je predmet odobritve, sestave pripravkov, materialov ali izdelkov, v katerih vlagatelj namerava uporabiti to snov, metod proizvodnje teh pripravkov, materialov ali izdelkov, nečistoč ter rezultatov migracijskih preskusov;
English: (36) To ensure that sectoral specificities with respect to confidential information are taken into account, it is necessary to weigh up the relevant rights of the public to transparency in the risk assessment process, including those flowing from the Aarhus Convention, against the rights of commercial applicants, taking into account the specific objectives of sectoral Union legislation as well as experienced gained.
Translation (en-sl): (36) Za zagotovitev, da se upoštevajo sektorske posebnosti glede zaupnih informacij, je treba ustrezne pravice javnosti do preglednosti v postopku ocenjevanja tveganja, vključno s tistimi, ki izhajajo iz Aarhuške konvencije, ponderirati glede na pravice poslovnih vlagateljev, ob upoštevanju posebnih ciljev sektorske zakonodaje Unije in pridobljenih izkušenj.
English: To align EFSA Management Board with the Inter-Institutional agreement to include Member States in the Management Board, similarly to other Union agencies and provide for an increased involvement of Member States in the appointment of scientific experts as it is the case in other similar scientific Union agencies.
Translation (en-sl): Uskladitev upravnega odbora agencije EFSA z medinstitucionalnim sporazumom za vključitev držav članic v upravni odbor, podobno kot pri drugih agencijah Unije, ter zagotovitev večje vključenosti držav članic v imenovanje znanstvenih strokovnjakov, kot je značilno za druge podobne znanstvene agencije Unije.
English: Risk communication is defined as the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions amongst risk assessors, risk managers, consumers, feed and food businesses, the academic community, including the explanation of risk assessment findings and the basis of risk management decisions.
Translation (en-sl): Obveščanje o tveganju je opredeljeno kot interaktivna izmenjava informacij in mnenj v postopku analize tveganja glede nevarnosti in tveganj, dejavnikov, povezanih s tveganji, ter dojemanja tveganja med odgovornimi za oceno tveganja, odgovornimi za obvladovanje tveganja, potrošniki, podjetji, ki poslujejo z živili in krmo, akademsko skupnostjo, vključno s razlago ugotovitev iz ocene tveganja in podlage za odločitve o obvladovanju tveganja.
English: As indicated, the measures create small additional burdens for applicants since they are limited to the notifications of commissioned studies in all cases and of planned studies in the case of renewals, given that the submission of studies in authorisation application is already foreseen in existing legislation.
Translation (en-sl): Kot je navedeno, ukrepi povzročajo le majhno dodatno breme za vlagatelje, saj so omejeni na obveščanje o naročenih študijah v vseh primerih in o načrtovanih študijah v primeru obnovitev ter je priložitev študij vlogi za odobritev določena že v obstoječi zakonodaji.
English: Where the withdrawal of the application takes place before the Authority has decided on the relevant confidentiality request, the Authority, the Commission and the Member States shall not make public the information for which confidentiality has been requested.
Translation (en-sl): Kadar vlagatelj umakne vlogo, preden se agencija odloči o zadevni zahtevi za zaupnost, agencija, Komisija in države članice ne objavijo informacij, za katere je bila zahtevana zaupna obravnava.
English: [52: See Articles 11 and 17 of Council Regulation (EU, Euratom) No 1311/2013 laying down the multiannual financial framework for the years 2014-2020.]
Translation (en-sl): [52: Glej člena 11 in 17 Uredbe Sveta (EU, Euratom) št. 1311/2013 o večletnem finančnem okviru za obdobje 2014-2020.]
English: The Authority shall lay down in its internal rules the practical arrangements for implementing the transparency rules referred to in paragraphs 1, 1a and 2 of this Article, taking into account Articles 39 to 39g and Article 41.
Translation (en-sl): Agencija v svojem poslovniku določi praktično ureditev za izvajanje pravil o preglednosti iz odstavkov 1, 1a in 2 tega člena, ob upoštevanju členov 39 do 39g in člena 41.
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-sl): Take informacije bi moralo biti dovoljeno razkriti samo v zelo omejenih in izjemnih okoliščinah, povezanih s predvidljivimi učinki na zdravje in nujno potrebo po varovanju zdravja ljudi in živali ali okolja.
English: Duration and financial impact
Translation (en-sl): Trajanje ukrepa in finančnih posledic
English: Risk management is defined as the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options.
Translation (en-sl): Obvladovanje tveganja je, za razliko od ocene tveganja, opredeljeno kot postopek presojanja možnosti politike v posvetovanju z zainteresiranimi stranmi, ob upoštevanju ocene tveganja in drugih upravičenih dejavnikov ter po potrebi izbora ustreznih možnosti za preprečevanje in nadzor.
English: The present proposal provides one empowerment for a delegated act in the context of Regulation (EC) No 178/2002, which is in the process of being aligned.
Translation (en-sl): Ta predlog določa eno pooblastilo za delegirani akt v okviru Uredbe (ES) št. 178/2002, ki je v postopku usklajevanja.
English: The Authority shall lay down in its internal rules the practical arrangement for implementing the procedures referred to in Articles 32a and this Article.
Translation (en-sl): Agencija v svojem poslovniku določi praktično ureditev za izvajanje postopkov iz člena 32a in tega člena.
English: Confidentiality
Translation (en-sl): Zaupnost
English: The GFL Fitness Check has also highlighted the need to establish a more comprehensive monitoring system of the implementation of Union food law, so as to provide policy makers and the public with more solid data and evidence base to regularly assess the relevant impacts.
Translation (en-sl): Pri preverjanju ustreznosti splošne živilske zakonodaje je bila prav tako izpostavljena potreba po vzpostavitvi bolj celovitega sistema za spremljanje izvajanja živilske zakonodaje Unije, da bi oblikovalcem politik in javnosti dali na voljo bolj zanesljive podatke in dokaze za redno oceno zadevnih učinkov.
English: Where Union food law provides that an authorisation may be renewed, the potential applicant for the renewal shall notify the Authority of the studies it intends to perform for that purpose.
Translation (en-sl): Če živilska zakonodaja Unije določa, da se odobritev lahko obnovi, morebitni vlagatelj vloge za obnovitev uradno obvesti agencijo o študijah, ki jih namerava izvesti v ta namen.
English: To address the emerging challenges in the area of food law in light of the experience gained to date (Fitness Check of the GFL Regulation published on 15 January 2018) and the Commission's reply to the ECI.
Translation (en-sl): Obravnava izzivov, ki se pojavljajo na področju živilske zakonodaje, glede na do zdaj pridobljene izkušnje (preverjanje ustreznosti uredbe o splošni živilski zakonodaji, objavljeno 15. januarja 2018) in odgovor Komisije na evropsko državljansko pobudo.
English: With regard to additional controls on the conduct of studies, the two measures proposed (audit/controls by Union inspectors and possibility to commission ad hoc studies in exceptional circumstances with the aim to verify evidence used by EFSA in its risk assessment), will provide additional assurances on the quality and objectivity of the studies used by EFSA for its risk assessment while not impacting on innovation since limited to specific or exceptional cases.
Translation (en-sl): Kar zadeva dodatni nadzor nad izvajanjem študij, se bodo z obema predlaganima ukrepoma (presoja/nadzor, ki jo/ga izvajajo inšpektorji Unije, in možnost naročanja ad hoc študij v izjemnih okoliščinah, da se preverijo dokazi, ki jih je EFSA uporabila v svoji oceni tveganja) zagotovila dodatna jamstva za kakovost in objektivnost študij, ki jih je EFSA uporabila v svoji oceni tveganja, ne da bi to zaviralo inovacije, saj sta omejena na posebne in izjemne primere.
English: Where the Commission requests an opinion from, the European Food Safety Authority (‘the Authority'), the Authority shall ensure public access to the application in accordance with Article 23 and shall give its opinion as to whether the update is liable to have an effect on human health.
Translation (en-sl): Kadar Komisija zahteva mnenje Evropske agencije za varnost hrane (v nadaljnjem besedilu: Agencija), Agencija v skladu s členom 23 zagotovi javni dostop do vloge in poda mnenje, ali bi lahko posodobitev vplivala na zdravje ljudi.
English: Compliance costs for businesses will not increase because existing rules already require applications including studies to be submitted to the relevant regulatory authority, e.g. the Commission, EFSA and the Member States, followed by confidentiality claims.
Translation (en-sl): Stroški izpolnjevanja obveznosti za podjetja se ne bodo povečali, saj obstoječa pravila že zahtevajo vložitev vlog pri zadevnem regulativnem organu, na primer Komisiji, agenciji EFSA in državah članicah, ki vključujejo študije in zadevne zahteve za zaupnost.
English: According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter.
Translation (en-sl): V skladu s tem načelom in veljavnimi regulativnimi zahtevami morajo vlagatelji v podporo vlogam za odobritev na podlagi sektorske živilske zakonodaje Unije predložiti ustrezne študije, vključno s preizkusi, da se dokažeta varnost in v nekaterih primerih učinkovitost predmeta.
English: Governance and greater Member State involvement in the Management Board: The proposal will align EFSA's governance with the model used for other Union agencies in line with the inter-institutional Common Approach on Union decentralised agencies, thus increasing the global consistency of the Union agencies' Management Board model.
Translation (en-sl): Upravljanje in večja vključenost držav članic v upravnem odboru: Predlog bo upravljanje agencije EFSA prilagodil modelu, ki se uporablja za druge agencije Unije, v skladu z medinstitucionalnim skupnim pristopom k decentraliziranim agencijam Unije, s čimer se bo povečala globalna usklajenost modela upravnega odbora agencij Unije.
English: under HEADING 5
Translation (en-sl): RAZDELKA 5
English: (a) promote awareness and understanding of the specific issues under consideration during the entire risk analysis process;
Translation (en-sl): (a) spodbujanje ozaveščenosti o posebnih vprašanjih, obravnavanih v celotnem postopku analize tveganja, in njihovega razumevanja;
English: While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment.
Translation (en-sl): Poleg ohranjanja načela, da breme za dokazovanje skladnosti z zahtevami Unije nosi industrija, je pomembno vzpostaviti dodatno orodje za preverjanje za obravnavo posebnih primerov, ki so za družbo zelo pomembni in povzročajo polemiko glede varnosti, tj. naročanje dodatnih študij za preverjanje dokazov, uporabljenih v postopku ocenjevanja tveganja.
English: (23) The Fitness Check of the General Food Law demonstrated that although the Authority has made considerable progress in terms of transparency, the risk assessment process, especially in the context of authorisation procedures covering the agri-food chain, is not always perceived as fully transparent.
Translation (en-sl): (23) Pri preverjanju ustreznosti splošne živilske zakonodaje se je pokazalo, da se postopek ocenjevanja tveganja, zlasti glede postopkov odobritve za agroživilsko verigo, kljub precejšnjemu napredku Agencije v smislu preglednosti, ne dojema vedno kot popolnoma pregleden.
English: (b) one member appointed by the European Parliament, with the right to vote.
Translation (en-sl): (b) en član z glasovalno pravico, ki ga imenuje Evropski parlament;
English: under HEADINGS 1 to 5
Translation (en-sl): RAZDELKOV od 1 do 5
English: However, given the limits of its competence, EFSA's risk communication activities cannot address questions on issues other than science, notably the risk management decisions informed by its scientific advice.
Translation (en-sl): Zaradi njenih omejenih pristojnosti pa lahko dejavnosti agencije EFSA na področju obveščanja o tveganju zajemajo le znanstvena vprašanja, zato zlasti ne sme obveščati o odločitvah glede obvladovanja tveganja, sprejetih na podlagi njenega znanstvenega mnenja.
English: In order of multiannual financial framework headings and budget lines.
Translation (en-sl): Po vrstnem redu razdelkov večletnega finančnega okvira in proračunskih vrstic.
English: (31) For the purposes of increased transparency and in order to ensure that requests for scientific outputs received by the Authority are processed in an effective manner, standard data formats and software packages should be developed.
Translation (en-sl): (31) Za namene povečane preglednosti in zagotovitev učinkovite obravnave zaprosil za znanstvene prispevke, ki jih prejme Agencija, bi bilo treba razviti standardne formate podatkov in pakete programske opreme.
English: (a) make public, without delay, the non-confidential version, as submitted by the applicant;
Translation (en-sl): (a) nemudoma objavi nezaupno različico, kot jo je predložil vlagatelj;
English: (a) two members and the alternate members appointed by the Commission and representing the Commission, with the right to vote.
Translation (en-sl): (a) dva člana in nadomestna člana z glasovalno pravico, ki jih imenuje Komisija in predstavljajo Komisijo;
English: Total 8.5 14.9 21.2 21.2 21.2
Translation (en-sl): Skupaj 8,5 14,9 21,2 21,2 21,2
English: Insourcing routine work 15 FTEs 0.775 1.357 1.938
Translation (en-sl): Notranje izvajanje rutinskega dela 15 EPDČ 0,775 1,357 1,938
English: The Commission and the Member States shall take the necessary measures so that information received by them under Union food law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the Authority and has become definitive.
Translation (en-sl): Komisija in države članice sprejmejo potrebne ukrepe, da ne objavijo informacij, ki jih prejmejo na podlagi živilske zakonodaje Unije in za katere se zahteva zaupna obravnava, dokler agencija ne sprejme odločitve o zahtevi za zaupnost in ta ne postane dokončna.
English: Public access to all scientific data and information supporting requests for authorisations under Union food law as well as other requests for scientific output should be ensured, as early as possible in the risk assessment process.
Translation (en-sl): Zagotoviti bi bilo treba javni dostop do vseh znanstvenih podatkov in informacij v podporo vlogam za odobritev na podlagi živilske zakonodaje Unije ter zaprosilom za znanstvene prispevke, in sicer čim bolj zgodaj v postopku ocenjevanja tveganja.
English: The impact on the duration of the authorisation procedures is minimal since this procedure is at the pre-submission stage and it may have a positive impact in reducing the length of authorisation procedures, as concerns may be raised and addressed early on in the process.
Translation (en-sl): Učinek na trajanje odobritvenih postopkov je minimalen, saj poteka obveščanje pred vložitvijo vloge, lahko pa je učinek tudi pozitiven v obliki skrajšanih odobritvenih postopkov, saj se lahko pomisleki izrazijo in obravnavajo že zgodaj v postopku.
English: "(c) the Authority shall without delay:
Translation (en-sl): „(c) Agencija nemudoma:
English: (c) the names of all participants in meetings of the Scientific Committee and the Scientific Panels and their Working Groups.
Translation (en-sl): (c) imena vseh udeležencev zasedanj znanstvenega odbora in znanstvenih svetov ter njihovih delovnih skupin;
English: It is proposed to empower the Commission to draw up this general plan for the purposes of Regulation (EC) No 178/2002 by means of delegated acts.
Translation (en-sl): V predlogu je predlagano, da se Komisija pooblasti, da z delegiranimi akti pripravi ta splošni načrt za namene Uredbe (ES) št. 178/2002.
English: The measures establishing a register of commissioned studies and the measure providing for a consultation on submitted studies will bring benefits by ensuring that EFSA has access to as much evidence as possible on a substance submitted for its assessment.
Translation (en-sl): Ukrepi za vzpostavitev registra naročenih študij in za izvedbo posvetovanja o predloženih študijah bodo prinesli koristi, saj bodo zagotovili, da ima EFSA dostop do čim več dokazov o snovi, predloženi v njeno oceno.
English: This principle is based on the premise that public health is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market.
Translation (en-sl): To načelo temelji na predpostavki, da se javno zdravje bolje varuje, če dokazno breme nosi vlagatelj, ki mora dokazati, da je določen predmet varen, preden se da na trg, namesto da bi javni organi morali dokazati, da predmet ni varen, da bi se lahko prepovedalo njegovo dajanje na trg.
English: The information systems operated by the Authority to store its data, including confidential and personal data shall be designed to a high level of security appropriate to the security risks at stake, taking into account Articles 39 to 39f of this Regulation.
Translation (en-sl): Informacijski sistemi, ki jih uporablja agencija za shranjevanje podatkov, vključno z zaupnimi in osebnimi podatki, so zasnovani tako, da zagotavljajo visoko raven varnosti, primerno varnostnim tveganjem, pri čemer se upoštevajo členi 39 do 39f te uredbe.
English: It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority.
Translation (en-sl): Bistvenega pomena je, da je vloga za odobritev, ki se predloži Agenciji za oceno tveganja, v skladu z veljavnimi specifikacijami, da se zagotovi, da Agencija pripravi znanstveno oceno najvišje kakovosti.
English: (a) The Authority shall draw up draft standard data formats and software packages for the purposes of the different authorisation procedures in Union food law and relevant requests for a scientific output by the European Parliament, the Commission and the Member States.
Translation (en-sl): (a) Agencija predlaga standardne oblike zapisa podatkov in pakete programske opreme za različne odobritvene postopke v živilski zakonodaji Unije in zadevna zaprosila Evropskega parlamenta, Komisije in držav članic za znanstveni prispevek.
English: Governance and greater Member State involvement in nominating Scientific Panel experts: the benefit of greater Member State involvement in this aspect of EFSA's work is expected to be to ensure it has access to a sufficiently large pool of independent and excellent experts meeting its needs in the different disciplines areas it deals with.
Translation (en-sl): Upravljanje in večja vključenost držav članic pri imenovanju strokovnjakov znanstvenih svetov: Večja vključenost držav članic v ta vidik dela agencije EFSA naj bi agenciji zagotovila dostop do zadosti velikega nabora neodvisnih in odličnih strokovnjakov, ki izpolnjujejo njene potrebe na različnih področjih njenega dela.