qanastek/ELRC-Medical-V2 huggingface dataset:
English: strengthen the ability of EFSA to maintain a high level of scientific expertise in the different areas of its work, especially its capacity to attract excellent scientists to be members of its Scientific Panels; bearing the related financial and budgetary aspects in mind too, and,
Translation (en-sl): okrepitve zmogljivosti agencije EFSA za ohranjanje visoke ravni strokovnega znanja na različnih področjih njenega dela, zlasti njene zmožnosti privabljanja odličnih znanstvenikov k članstvu v znanstvenih svetih; in tudi upoštevanja zadevnih finančnih in proračunskih vidikov ter
English: (a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and,
Translation (en-sl): (a) informacij o zaporedju DNK, razen zaporedjih, ki se uporabljajo za odkrivanje, identifikacijo in količinsko določanje transformacijskega dogodka, ter
English: EFSA is currently empowered to communicate on its own initiative in the fields within its mission, without prejudice to the Commission's competence to communicate its risk management decisions.
Translation (en-sl): EFSA je trenutno pooblaščena, da na lastno pobudo izvaja dejavnosti obveščanja na področjih svojega poslanstva, ne da bi pri tem posegala v pristojnost Komisije obveščanja o odločitvah glede obvladovanja tveganja.
English: Member States shall ensure that the public bodies employing those scientific experts and those having responsibility for the setting of priorities of the scientific bodies employing those experts implement the measures provided for in paragraph 5d.
Translation (en-sl): Države članice zagotovijo, da javni organi, ki zaposlujejo navedene znanstvene strokovnjake, in pristojni za določanje prednostnih nalog znanstvenih organov, ki zaposlujejo navedene strokovnjake, izvajajo ukrepe iz odstavka 5d.
English: Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available).
Translation (en-sl): Upoštevati bi bilo treba dejstvo, da mora biti področje uporabe naročenih študij v nekaterih posebnih primerih širše od zadevnega dokaza (če so na primer na voljo nova znanstvena dognanja).
English: Since they concern the authorisation of a substance already on the market for several years and given that they address planned studies, the experience from the similar procedures under ECHA shows that there is public knowledge and in some cases new data that can be usefully shared concerning the substance at issue.
Translation (en-sl): Ker se te obveznosti nanašajo na odobritev snovi, ki je na trgu že več let, in glede na to, da se nanašajo na načrtovane študije, izkušnje s podobnimi postopki v primeru agencije ECHA kažejo, da je na voljo javno znanje in v nekaterih primerih novi podatki o zadevni snovi, ki so lahko koristni.
English: In that respect, the proposal sets outs which type of information is to be considered confidential.
Translation (en-sl): V zvezi s tem ta predlog določa, katere vrste informacij je treba obravnavati kot zaupne.
English: The Member States shall put in place measures ensuring that the members of the Scientific Panels act independently and remain free from conflict of interests as provided for in Article 37(2) and the Authority's internal measures.
Translation (en-sl): Države članice sprejmejo ukrepe, ki zagotavljajo, da člani znanstvenih svetov delujejo neodvisno in brez nasprotja interesov, kakor je določeno v členu 37(2) ter notranjih ukrepih agencije.
English: (b) information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable health effects.
Translation (en-sl): (b) informacije, ki so del ugotovitev znanstvenih prispevkov, vključno z znanstvenimi mnenji, ki jih je izdala agencija in se nanašajo na predvidljive učinke na zdravje.
English: Dependence on a small number of Member States that provide more than two thirds of the EFSA's Scientific Panels' experts and difficulties in receiving sufficient support from many Member States for its scientific work (e.g. by providing studies, or data).
Translation (en-sl): odvisnost od majhnega števila držav članic, ki prispevajo več kot dve tretjini strokovnjakov v znanstvene svete agencije EFSA, ter nezadostna podpora iz številnih držav članic pri njenem znanstvenem delu (npr. s pripravo študij ali podatkov).
English: Transparency: The proposal aims at strengthening the transparency of the risk assessment process.
Translation (en-sl): Preglednost: S predlogom naj bi se povečala preglednost postopka ocene tveganja.
English: Laboratory related audit can be performed by existing service SANTE.F "Health and Food audits and analysis".
Translation (en-sl): Presoje v zvezi z laboratoriji lahko izvaja obstoječa služba GD SANTE za presoje in analize na področju zdravja in hrane (direktorat F).
English: It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein.
Translation (en-sl): Sklep začne učinkovati dan po njegovi objavi v Uradnem listu Evropske unije ali na poznejši dan, ki je določen v navedenem sklepu.
English: Divergences between Union and national risk assessors, however, do not necessarily question the work of the different scientific bodies.
Translation (en-sl): Razhajanja med odgovornimi za oceno tveganja na nacionalni ravni in ravni Unije pa nujno ne prinašajo dvomov o delu različnih znanstvenih organov.
English: This is because companies going to laboratories outside the Union would take the risk to be perceived as evading the rules.
Translation (en-sl): Podjetja, ki se odločijo za laboratorije zunaj Unije, bi namreč tvegala, da bi se tako ravnanje lahko razumelo kot izogibanje pravilom.
English: Standard data formats
Translation (en-sl): Standardne oblike zapisa podatkov
English: Moreover, as indicated in the GFL Fitness Check, food and feed safety measures have the greatest effect when taken at Union level.
Translation (en-sl): Poleg tega imajo, kot je bilo ugotovljeno pri preverjanju ustreznosti splošne živilske zakonodaje, ukrepi za varnost živil in krme največji učinek, kadar so sprejeti na ravni Unije.
English: By strengthening the EFSA's governance and making risk assessment more sustainable, it will ensure that EFSA will continue to play a fundamental role in the Union food safety system and to contribute to the health and wellbeing of Union citizens and to an innovative and competitive Union agri-food industry.
Translation (en-sl): Predlog bo z okrepitvijo upravljanja agencije EFSA in povečanjem vzdržnosti sistema ocenjevanja tveganja zagotovil, da bo EFSA še naprej imela pomembno vlogo v sistemu Unije za varnost hrane ter prispevala k zdravju in dobrobiti državljanov Unije ter k inovativni in konkurenčni agroživilski industriji Unije.
English: It is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby Member State controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the Commission.
Translation (en-sl): Primerno je določiti dodatno raven jamstev, da bi splošni javnosti dali zagotovila glede kakovosti študij in določili okrepljen sistem presoj, v skladu s katerim bi Komisija preverjala nadzor držav članic nad izvajanjem navedenih načel v laboratorijih, ki izvajajo take študije in preizkuse.
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-sl): Navedene člane imenuje Svet po posvetovanju z Evropskim parlamentom na podlagi seznama, ki ga sestavi Komisija in vključuje več imen, kot je prostih delovnih mest.
English: (b) Taking into account the applicable requirements in the different authorisation procedures and other legislative frameworks and following any necessary adaptations, the Commission shall adopt standard data formats and software by means of implementing acts.
Translation (en-sl): (b) Ob upoštevanju veljavnih zahtev v različnih odobritvenih postopkih in drugih zakonodajnih okvirov ter po vseh potrebnih prilagoditvah Komisija z izvedbenimi akti sprejme standardne oblike zapisa podatkov in programsko opremo.
English: There is only a very limited risk that notification by laboratories, meaning only Union laboratories, could have negative impacts on their competitiveness vis-à-vis non-Union laboratories, or that the overall effectiveness of the measure may be undermined by applicants deciding to carry out studies in laboratories outside the Union to circumvent the notification obligation.
Translation (en-sl): Obstaja le zelo majhno tveganje, da bi obveznost obveščanja za laboratorije, tj. samo laboratorije Unije, lahko negativno vplivala na njihovo konkurenčnost v primerjavi z neunijskimi laboratoriji ali da bi skupno učinkovitost ukrepa lahko ogrozili vlagatelji, ki se odločijo, da bodo študije izvedli v laboratorijih zunaj Unije ter se tako izognili obveznosti obveščanja.
English: The Authority shall lay down in its internal rules the practical arrangements for implementing the notification obligations laid down in paragraphs 1 and 2, including consequences of non-compliance with the notification obligation.
Translation (en-sl): Agencija v svojem poslovniku določi praktično ureditev za izvajanje obveznosti uradnega obveščanja iz odstavkov 1 in 2, vključno s posledicami neizpolnjevanja obveznosti uradnega obveščanja.
English: The application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application.
Translation (en-sl): Vloga se šteje za umaknjeno od trenutka, ko pristojni organ, ki je prejel prvotno vlogo, prejme pisno zahtevo.
English: (1) Regulation (EC) No 178/2002 of the European Parliament and of the Council lays down the general principles and requirements of food law, so as to form a common basis for measures governing food law both at Union and Member State level.
Translation (en-sl): (1) Uredba (ES) št. 178/2002 Evropskega parlamenta in Sveta določa splošna načela in zahteve živilske zakonodaje, da se oblikuje skupna podlaga za ukrepe glede živilske zakonodaje tako na ravni Unije kot na ravni držav članic.
English: The register of commissioned studies will have a positive impact on the objectivity of the evidence submitted by industry since it will provide additional guarantee that applicants submit all studies they have performed on a substance -whatever their results.
Translation (en-sl): Register naročenih študij bo pozitivno vplival na objektivnost dokazov, ki jih predloži industrija, saj bo pomenil dodatno jamstvo, da vlagatelji predložijo vse študije, ki so jih izvedli v zvezi snovjo - ne glede na njihove rezultate.
English: (1) the method and other technical and industrial specifications relating to that method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion;
Translation (en-sl): (1) metode ter drugih tehničnih in industrijskih specifikacij za navedeno metodo, uporabljeno za izdelavo ali proizvodnjo predmeta, na katerega se nanaša zaprosilo za znanstveni prispevek, vključno z znanstvenim mnenjem;
English: Transparency and confidentiality
Translation (en-sl): Preglednost in zaupnost
English: (10) It is appropriate to align the composition of the Management Board of the Authority to the Common Approach on decentralised agencies, in accordance with the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies of 2012.
Translation (en-sl): (10) Sestavo upravnega odbora Agencije je primerno uskladiti s skupnim pristopom k decentraliziranim agencijam, v skladu s skupno izjavo Evropskega parlamenta, Sveta Evropske unije in Evropske komisije o decentraliziranih agencijah iz leta 2012.
English: At the same time, the proposal is expected to ensure the long-term sustainability of EFSA's capacity of scientific expertise.
Translation (en-sl): S predlogom pa naj bi hkrati zagotovili dolgoročno trajnost zmogljivosti agencije EFSA za ohranjanje strokovnega znanja.
English: Given the targeted nature of this revision, focussing on transparency, the main simplification aspect concerns the introduction of a pre-submission advice which should provide support to applicants, in particular SMEs, to better understand the specifications on content of applications.
Translation (en-sl): Ker je ta revizija usmerjena v preglednost, se glavni vidik poenostavitve nanaša na uvedbo svetovanja pred vložitvijo vloge, s katerim bi se morala zagotoviti podpora vlagateljem, zlasti MSP, da bi bolje razumeli specifikacije glede vsebine vlog.
English: (4) quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion.
Translation (en-sl): (4) kvantitativne sestave predmeta, na katerega se nanaša zaprosilo za znanstveni prispevek, vključno z znanstvenim mnenjem.
English: Recent debates raised concerns on transparency and independence of industry-generated studies and data.
Translation (en-sl): V nedavnih razpravah so bili izraženi pomisleki glede preglednosti in neodvisnosti študij in podatkov industrije.
English: (b) specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment.
Translation (en-sl): (b) specifikacij nečistoč aktivne snovi in ustreznih metod analize, ki jih je vložnik interno razvil, razen nečistoč, ki bi lahko imele škodljive učinke na zdravje živali, zdravje ljudi ali okolje.
English: The EFSA's effectiveness depends on its capacity to attract and pool expertise from Member States.
Translation (en-sl): Učinkovitost agencije EFSA je odvisna od njene zmožnosti, da pritegne in združi strokovno znanje iz držav članic.
English: The Authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment.
Translation (en-sl): Agencija že pregleduje znanstveno literaturo, da bi lahko upoštevala druge podatke in študije o predmetu, na katerega se nanaša njena ocena.
English: [19: OJ C , , p.
Translation (en-sl): [19: UL C , , str.
English: (iii) Meeting the needs for the specific multi-disciplinary expertise of the Panel to which they will be appointed and the applicable language regime.
Translation (en-sl): (iii) izpolnjevanje potreb po posebnih večdisciplinarnih strokovnih znanjih znanstvenega sveta, v katerega bodo imenovani, in potreb veljavne jezikovne ureditve.
English: (b) provide transparent information at each stage of the risk analysis process from the framing of requests for scientific advice to the provision of risk assessment and the adoption of risk management decisions;
Translation (en-sl): (b) zagotavljati pregledne informacije na vsaki stopnji postopka analize tveganja, od oblikovanja zaprosil za znanstveno mnenje do predložitve ocene tveganja in sprejetja odločitev o obvladovanju tveganja;
English: For the purposes of risk assessment at Union level, it establishes the European Food Safety Authority ("the Authority"), as the responsible Union risk assessment body in matters relating to food and feed safety.
Translation (en-sl): Za namene ocene tveganja na ravni Unije ustanavlja Evropsko agencijo za varnost hrane (v nadaljnjem besedilu: Agencija) kot pristojni organ Unije za ocenjevanje tveganja glede zadev, povezanih z varnostjo hrane in krme.
English: (13) The Fitness Check of the General Food Law identified certain shortcomings in the long-term capability of the Authority to maintain its high-level expertise.
Translation (en-sl): (13) Pri preverjanju ustreznosti splošne živilske zakonodaje so bile ugotovljene nekatere pomanjkljivosti pri dolgoročni zmogljivosti Agencije za ohranjanje strokovnega znanja na visoki ravni.
English: The GFL Fitness Check and recent public debates have shown that certain aspects of the current legislative framework need to be addressed.
Translation (en-sl): Pri preverjanju ustreznosti splošne živilske zakonodaje in v nedavnih javnih razpravah se je pokazalo, da je treba obravnavati nekatere vidike sedanjega zakonodajnega okvira.
English: (30) It is also necessary to set out specific requirements with respect to the protection of personal data for the purposes of the transparency of the risk assessment process taking into account Regulation (EC) No 45/2001 of the European Parliament and of the Council and Regulation (EU) 2016/679 of the European Parliament and of the Council.
Translation (en-sl): (30) Prav tako je treba določiti posebne zahteve v zvezi z varstvom osebnih podatkov za namene preglednosti postopka ocenjevanja tveganja ob upoštevanju Uredbe (ES) št. 45/2001 Evropskega parlamenta in Sveta in Uredbe (EU) 2016/679 Evropskega parlamenta in Sveta.
English: The option having Member States requesting EFSA to commission studies in exceptional circumstances as well as the option having EFSA commissioning such studies on its own motion were not chosen in the end for reasons of proportionality (public financing) but also because the EFSA and Member States can already signal to the Commission specific reasons to make use of this specific tool.
Translation (en-sl): Možnost, da lahko države članice od agencije EFSA zahtevajo, da naroči študije v izjemnih okoliščinah, ter možnost, da lahko EFSA naroča take študije na lastno pobudo, na koncu nista bili izbrani zaradi sorazmernosti (javno financiranje), pa tudi zato, ker lahko EFSA in države članice že zdaj Komisijo opozorijo na posebne razloge za uporabo tega specifičnega orodja.
English: Those arrangements shall however be in accordance with the present Regulation and other Union sectoral food law.
Translation (en-sl): Navedena ureditev je v skladu s to uredbo in drugo sektorsko živilsko zakonodajo Unije.
English: EFSA has in place and strictly monitors its rules on "independence" and "conflict of interest"; Control method(s) envisaged
Translation (en-sl): EFSA ima vzpostavljena pravila o „neodvisnosti" in „nasprotju interesov", ki jih pozorno spremlja; načrtovani načini kontrole
English: Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Inter-institutional Agreement on Better Law-Making of 13 April 2016.
Translation (en-sl): Komisija se pred sprejetjem delegiranega akta posvetuje s strokovnjaki, ki jih imenuje posamezna država članica, v skladu z načeli iz Medinstitucionalnega sporazuma o boljši pripravi zakonodaje z dne 13. aprila 2016.
English: (7) the following Articles 39a to 39g are inserted:
Translation (en-sl): (7) vstavijo se naslednji členi 39a do 39g:
English: Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.
Translation (en-sl): Navedite, kakšne posledice naj bi imel(-a) predlog/pobuda za upravičence/ciljne skupine.
English: The impetus for the GFL Regulation came from a succession of food related crises, notably the Bovine Spongiform Encephalopathy (BSE) crisis, foot and mouth disease and dioxin in the late 90s-early 2000s.
Translation (en-sl): Povod za uredbo o splošni živilski zakonodaji je bila vrsta prehranskih kriz v poznih devetdesetih letih 20. in v začetku 21. stoletja, zlasti kriza v zvezi z govejo spongiformno encefalopatijo (BSE), slinavko in parkljevko ter dioksinom.
English: The term of office of the members referred to in paragraph 1a(c) may be renewable only once.
Translation (en-sl): Mandat članov iz odstavka 1a(c) se lahko samo enkrat podaljša.
English: (3) The evaluation of Regulation (EC) No 178/2002, ("Fitness Check of the General Food Law"), found that risk communication is overall, not considered to be effective enough, which has an impact on consumers' confidence on the outcome of the risk analysis process.
Translation (en-sl): (3) Pri oceni Uredbe (ES) št. 178/2002 („preverjanje ustreznosti splošne živilske zakonodaje") je bilo ugotovljeno, da se obveščanje o tveganju na splošno ne šteje za dovolj učinkovito, kar vpliva na zaupanje potrošnikov v rezultat postopka analize tveganja.
English: [20: OJ C , , p.
Translation (en-sl): [20: UL C , , str.
English: (39) The appointment of the Scientific Committee and Scientific Panels' members being dependent of the entry in function of the new Management Board, it is necessary to provide for specific transitional provisions allowing a prolongation of the current term of office of the members of the Scientific Committee and Scientific Panels members.
Translation (en-sl): (39) Ker je imenovanje članov znanstvenega odbora in znanstvenih svetov odvisno od začetka delovanja novega upravnega odbora, je treba določiti posebne prehodne določbe, ki omogočajo podaljšanje sedanjega mandata članov znanstvenega odbora in znanstvenih svetov.
English: With respect to requests for scientific outputs, including scientific opinions under Union food law, the Authority shall always make public:
Translation (en-sl): V zvezi z zaprosili za znanstvene prispevke, med drugim tudi za znanstvena mnenja na podlagi živilske zakonodaje Unije, agencija vedno objavi:
English: The consultation on submitted studies does not create additional burdens since the obligation to submit studies to EFSA, Commission and Member States already exists.
Translation (en-sl): Posvetovanje o predloženih študijah ne bo povzročilo dodatnega bremena, saj že obstaja obveznost predložitve študij agenciji EFSA, Komisiji in državam članicam.
English: (a) identify the key factors that need to be taken into account when considering the type and level of risk communications' activities needed;
Translation (en-sl): (a) opredeljeni ključni dejavniki, ki jih je treba upoštevati pri določanju vrste in ravni potrebnih dejavnosti obveščanja o tveganju;
English: Regulation (EC) No 178/2002 on general food law (the "GFL" Regulation) provides for a comprehensive harmonised legal framework.
Translation (en-sl): Uredba (ES) št. 178/2002 o splošni živilski zakonodaji („uredba o splošni živilski zakonodaji") določa celovit in usklajen pravni okvir.
English: Alternatives considered:
Translation (en-sl): Obravnavane alternativne možnosti:
English: The risk that some Member States might not have enough experts to be able to provide the EFSA with valuable candidates is alleviated by the possibility for EFSA to select and appoint additional experts of its own accord and the possibility for Member States to appoint experts who have the nationality of other Member States.
Translation (en-sl): Tveganje, da nekatere države članice morda nimajo dovolj strokovnjakov, da bi lahko agenciji EFSA zagotovile ustrezne kandidate, se izravna z možnostjo, da lahko EFSA sama izbere in imenuje dodatne strokovnjake, ter možnostjo, da države članice imenujejo strokovnjake z državljanstvom druge države članice.
English: The Executive Director may not draw up such a list where he/she can justify that the nominations received do not allow him, given the criteria for selection set up in point d) of this paragraph, to draw up a larger list.
Translation (en-sl): Izvršni direktor ne sme pripraviti takega seznama, kadar lahko utemelji, da na podlagi prejetih predlogov ne more pripraviti daljšega seznama glede na merila za izbor iz točke (d) tega odstavka.