qanastek/ELRC-Medical-V2 huggingface dataset:
English: On transparency, the measures envisaged (i.e. proactive disclosure of non-confidential data, register of commissioned studies, voluntary pre-submission procedure, pre-notification of, and advice on planned studies in case of renewals, consultation of third parties on submitted studies) provide a robust framework which is proportional to the objective of enhancing citizens' confidence in the transparency of the system.
Translation (en-sl): Kar zadeva preglednost, se s predvidenimi ukrepi (na primer proaktivno razkritje nezaupnih podatkov, register naročenih študij, prostovoljni postopek pred vložitvijo vloge, predhodno obveščanje in svetovanje o načrtovanih študijah v primeru obnovitev, posvetovanje s tretjimi osebami o predloženih študijah) vzpostavlja trden okvir, ki je sorazmeren s ciljem krepiti zaupanje državljanov v preglednost sistema.
English: (37) In order to further strengthen the link between risk assessors and risk managers at Union and national levels as well as the coherence and consistency of risk communication, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain.
Translation (en-sl): (37) Da bi še dodatno okrepili povezavo med odgovornimi za oceno tveganja in odgovornimi za obvladovanje tveganja na ravni Unije in nacionalnih ravneh ter skladnost in doslednost obveščanja o tveganju, bi bilo treba na Komisijo prenesti pooblastilo, da v skladu s členom 290 Pogodbe sprejme akte za sprejetje splošnega načrta za obveščanje o tveganju glede zadev, povezanih z agroživilsko verigo.
English: It is appropriate to lay down in Regulation (EC) No 178/2002 a horizontal list of information items whose disclosure may be considered to significantly harm the commercial interests concerned and should not therefore be disclosed to the public, ("general horizontal list of confidential items").
Translation (en-sl): V Uredbi (ES) št. 178/2002 je primerno določiti horizontalni seznam informacij, katerih razkritje bi lahko veljalo za zelo škodljivo za zadevne poslovne interese in ki se zato ne bi smele razkriti javnosti („splošni horizontalni seznam zaupnih postavk").
English: There are still strong memories of the damage caused by successive food safety crises prior to the GFL Regulation which undermined the credibility of the Union to ensure that food is safe.
Translation (en-sl): Še dobro pomnijo škodo, ki so jo povzročile številne krize na področju varnosti hrane spred sprejetjem uredbe o splošni živilski zakonodaji, ki so omajale verodostojnost Unije, da je zmožna zagotavljati varno hrano.
English: These developments took place against the backdrop of public controversy over the approach towards the assessment and management of sensitive substances such as genetically modified organisms, and plant protection products, especially those containing glyphosate or potentially negative health impacts arising from endocrine disruptors.
Translation (en-sl): To dogajanje je sovpadalo z javno polemiko glede pristopa k ocenjevanju občutljivih snovi in ravnanju z njimi, na primer gensko spremenjenih organizmov in fitofarmacevtskih sredstev, zlasti tistih, ki vsebujejo glifosat ali imajo potencialno negativne učinke na zdravje, ki jih povzročajo endokrini motilci.
English: The Executive Director shall inform the Management Board of the requests sent to the Member States.
Translation (en-sl): Izvršni direktor obvesti upravni odbor o zaprosilih, poslanih državam članicam.
English: XX 01 04 yy[50: Sub-ceiling for external staff covered by operational appropriations (former ‘BA' lines).]
Translation (en-sl): XX 01 04 yy[50: Dodatna zgornja meja za zunanje sodelavce v okviru odobritev za poslovanje (prej vrstice BA).]
English: Function group and grade Year
Translation (en-sl): Funkcionalna skupina in razred Leto
English: Citizens / civil society perceive the risk assessment process as opaque and demand more transparency, due to several different transparency and confidentiality rules applicable to risk assessment and decision-making process, making the system complex and non-uniform.
Translation (en-sl): Državljani/civilna družba postopek ocenjevanja tveganja dojemajo kot nepregleden in zahtevajo večjo preglednost zaradi različnih pravil o preglednosti in zaupnosti, ki se uporabljajo za postopek ocenjevanja tveganja in odločanja, zaradi česar je sistem zapleten in neenoten.
English: The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests.
Translation (en-sl): Pri oceni bi bilo zlasti treba pregledati postopke za izbor članov znanstvenega odbora in svetov, njihovo stopnjo preglednosti, stroškovno učinkovitost in primernost, da se zagotovita neodvisnost in usposobljenost ter preprečijo nasprotja interesov.
English: The list of information referred to in paragraph 2 shall be without prejudice to any specific Union food law.
Translation (en-sl): Seznam informacij iz odstavka 2 ne posega v nobeno posebno živilsko zakonodajo Unije.
English: It is therefore essential to maintain the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation and independence of the Authority and transparency.
Translation (en-sl): Zato je bistveno ohraniti zaupanje splošne javnosti in drugih zainteresiranih strani v postopek analize tveganja, na katerem temelji živilska zakonodaja Unije, in zlasti v ocenjevanje tveganja, vključno z organizacijo in neodvisnostjo Agencije ter preglednostjo.
English: Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, and 168(4)(b) thereof,
Translation (en-sl): ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti člena 43, člena 114 in člena 168(4)(b) Pogodbe,
English: The Commission, in close cooperation with the Authority, the Member States and following appropriate public consultations shall be empowered to adopt delegated acts in accordance with Article 57a establishing a general plan for risk communication on matters relating to the agri-food chain, taking into account the relevant objectives and general principles set out in Articles 8a and 8b.
Translation (en-sl): Komisija je v skladu s členom 57a pooblaščena, da v tesnem sodelovanju z agencijo, državami članicami in po ustreznih javnih posvetovanjih sprejme delegirane akte o določitvi splošnega načrta obveščanja o tveganju glede zadev v zvezi z agroživilsko verigo, ob upoštevanju zadevnih ciljev in splošnih načel iz členov 8a in 8b.
English: Indeed, the science-based approach to food legislation, underpinned by the establishment and operation of EFSA at centralised level, has overall improved the scientific basis of measures taken in the area of food law and has further contributed to harmonised views between Member States on key safety issues as well as to the Union product safety recognition worldwide.
Translation (en-sl): Dejansko se je s znanstvenim pristopom k živilski zakonodaji, ki je temeljil na ustanovitvi in delovanju agencije EFSA na centralizirani ravni, na splošno izboljšala znanstvena podlaga za ukrepe, sprejete na področju živilske zakonodaje, prispeval pa je tudi k nadaljnji uskladitvi stališč med državami članicami o ključnih varnostnih vprašanjih ter k mednarodnemu priznanju varnosti proizvodov v Uniji.
English: persons entrusted with the implementation of specific actions in the CFSP pursuant to Title V of the TEU, and identified in the relevant basic act.
Translation (en-sl): osebam, pooblaščenim za izvajanje določenih ukrepov SZVP v skladu z naslovom V PEU in opredeljenim v zadevnem temeljnem aktu.
English: Amendments to Regulation (EC) No 178/2002
Translation (en-sl): Spremembe Uredbe (ES) št. 178/2002
English: (c) The Authority shall make the standard data formats and software packages, as adopted, available on its website.
Translation (en-sl): (c) Agencija da standardne oblike zapisa podatkov in pakete programske opreme, kot so bili sprejeti, na voljo na svojem spletišču.
English: (21) Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law usually comply with internationally recognised principles, which provide a uniform basis for their quality in particular in terms of reproducibility of results.
Translation (en-sl): (21) Študije, vključno s preizkusi, ki jih predložijo nosilci dejavnosti v podporo vlogam za odobritev na podlagi sektorske živilske zakonodaje Unije, so običajno v skladu z mednarodno priznanimi načeli, ki zagotavljajo enotno podlago za njihovo kakovost, zlasti z vidika ponovljivosti rezultatov.
English: There is no risk of duplication with the actual capacity of EFSA to commission scientific studies necessary for the performance of its mission (Article 32 of the GFL Regulation) as this is to be considered as a risk management tool.
Translation (en-sl): Ni tveganja, da bi prišlo do podvajanja dela z dejansko nalogo agencije EFSA, da naroči znanstvene študije, potrebne za izvajanje svojega poslanstva (člen 32 uredbe o splošni živilski zakonodaji), saj se to orodje obravnava kot orodje za obvladovanje tveganja.
English: (b) all its scientific outputs, including the opinions of the Scientific Committee and the Scientific Panels after adoption, minority opinions and results of consultations performed during the risk assessment process always being included;
Translation (en-sl): (b) vse svoje znanstvene prispevke, vključno z mnenji znanstvenega odbora in znanstvenih svetov po njihovem sprejetju, pri čemer vedno priloži manjšinska mnenja in rezultate posvetovanj, opravljenih med postopkom ocenjevanja tveganja;
English: Nevertheless, the following challenges have been identified: national differences in the implementation of the GFL Regulation at Member State level have been observed, creating in some instances uneven playing field for businesses; a perceived lack of transparency of the risk analysis process; risk communication is, overall, considered not to be effective enough, thus creating a negative impact on consumers' confidence and on the acceptability of risk management decisions; certain limitations in EFSA's capacity to ensure in the long-term sufficient expertise and to fully engage all Member States in scientific cooperation; lengthy authorisation procedures in some sectors.
Translation (en-sl): Kljub temu pa so bili opredeljeni naslednji izzivi: opažene so bile nacionalne razlike pri izvajanju uredbe o splošni živilski zakonodaji na ravni držav članic, kar v nekaterih primerih ustvarja neenake konkurenčne pogoje za podjetja; postopek analize tveganja se dojema kot ne dovolj pregleden; obveščanje o tveganju na splošno velja za ne dovolj učinkovito, kar ustvarja negativen učinek na zaupanje potrošnikov in na sprejemljivost odločitev o obvladovanju tveganja; nekatere omejitve zmogljivosti agencije EFSA za dolgoročno zagotavljanje ustreznega strokovnega znanja in pritegnitev vseh držav članic k znanstvenemu sodelovanju; dolgotrajni postopki odobritve v nekaterih sektorjih.
English: The Executive Director shall notify the Member States of the Authority's independence policy and implementing rules applicable to Scientific Panels' members.
Translation (en-sl): Izvršni direktor obvesti države članice o politiki neodvisnosti agencije in izvedbenih pravilih, ki se uporabljajo za člane znanstvenih svetov.
English: To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned.
Translation (en-sl): Zato je potrebno in primerno, da nosilci dejavnosti, ki naročijo študije, in laboratoriji, ki te študije izvajajo, študije ob naročilu priglasijo Agenciji.
English: These can be explained by a variety of factors including for instance: the legal framework to which the question refers, the type of question put to scientific bodies by the relevant risk managers and how these are framed, whether the assessment relates to a hazard or a risk, the methodologies followed, or the data, which are utilised.
Translation (en-sl): To je mogoče pojasniti z več dejavniki, med drugim: s pravnim okvirom, na katerega se nanaša vprašanje; z vrsto vprašanja, ki ga zadevni odgovorni za obvladovanje tveganja predložijo znanstvenim organom, ter način njegovega oblikovanja; ali se ocena nanaša na nevarnost ali tveganje; z uporabljenimi metodologijami ali podatki.
English: Amendments to Directive (EC) 2001/18/EC on the deliberate release into the environment of genetically modified organisms
Translation (en-sl): Spremembe Direktive 2001/18/ES o namernem sproščanju gensko spremenjenih organizmov v okolje
English: (b) any provisions set out in Union food law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations (‘data exclusivity rules').
Translation (en-sl): (b) katere koli določbe iz živilske zakonodaje Unije, ki ščitijo naložbe inovatorjev v zbiranje informacij in podatkov v podporo zadevnim vlogam za odobritev („pravila o izključnosti podatkov").
English: [24: Communication from the Commission on the ECI "Ban glyphosate and protect people and the environment from toxic pesticides", C(2017) 8414 final.]
Translation (en-sl): [24: Sporočilo Komisije o evropski državljanski pobudi „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi", C(2017) 8414 final.]
English: The members of the Management Board and where relevant, the alternate members shall be appointed taking into account high competence in the area of food safety risk assessment as well as competences in the food chain safety legislation and policy, and relevant managerial, administrative and budgetary/financial skills.
Translation (en-sl): Člani upravnega odbora in, kadar je ustrezno, nadomestni člani so imenovani na podlagi visoke usposobljenosti na področju ocenjevanja tveganja v zvezi z varnostjo hrane, pa tudi znanja na področju zakonodaje o varnosti prehranske verige in s tem povezane politike ter ustreznih vodstvenih, upravnih in proračunskih/finančnih sposobnosti.
English: EFSA's independence will not be affected to any extent since the scope of the advice that EFSA provides is limited to what the relevant provisions are and what the required content of the application at stake is.
Translation (en-sl): Neodvisnost agencije EFSA ne bo v nobenem smislu ogrožena, saj je svetovanje agencije EFSA omejeno na zadevne določbe in na zahtevano vsebino zadevne vloge.
English: By way of derogation from Article 38, the Authority shall not make public information for which confidential treatment has been requested under the conditions laid down in this Article.
Translation (en-sl): Z odstopanjem od člena 38 agencija ne objavi informacij, za katere se zahteva zaupna obravnava pod pogoji iz tega členu.
English: Moreover, public money should not be used to commission costly studies that will in the end 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, ki bodo na koncu industriji pomagale dati izdelek na trg.
English: As explained in the Roadmap, no impact assessment was carried out for this initiative, as the measures that are to be introduced by the proposal will mainly concern the transparency and the way the Commission as risk manager and the EFSA as risk assessor will gather and manage the evidence needed to perform their tasks on the basis of unchanged criteria.
Translation (en-sl): Kot je pojasnjeno v časovnem načrtu, za to pobudo ni bila izvedena ocena učinka, saj se bodo ukrepi, ki bodo uvedeni s predlogom, v glavnem nanašali na preglednost in način, kako Komisija kot odgovorna za obvladovanje tveganja in EFSA kot odgovorna za oceno tveganja na podlagi nespremenjenih meril zbirata in obravnavata dokaze, potrebne za opravljanje njunih nalog.
English: The proposal will not impinge on any intellectual property right which may exist over documents or their content, nor on any regulatory protection set out in Union sectoral legislation covering the agri-food chain rewarding investments (the so-called "data exclusivity rules").
Translation (en-sl): Predlog ne bo posegal v nobeno pravico intelektualne lastnine, ki lahko obstaja na dokumentih ali njihovi vsebini, niti v nobeno regulativno zaščito za spodbujanje naložb, ki je določena v sektorski zakonodaji Unije na področju agroživilske verige (t. i. „pravila o izključnosti podatkov").
English: The members of the Scientific Panels shall be appointed by the Management Board for a renewable five year term of office in accordance with the following procedure:
Translation (en-sl): Člane znanstvenih svetov imenuje upravni odbor za petletni mandat z možnostjo podaljšanja v skladu z naslednjim postopkom:
English: Impact assessment
Translation (en-sl): Ocena učinka
English: Member States shall ensure that the members of the Scientific Panels have the means to dedicate the necessary time and effort to contribute to the work of the Authority.
Translation (en-sl): Države članice zagotovijo, da lahko člani znanstvenih svetov posvetijo dovolj časa in truda delu agencije.
English: Further measures should also be put in place to ensure that scientific experts have the means to act independently.
Translation (en-sl): Vzpostaviti bi bilo treba tudi dodatne ukrepe, ki bodo omogočili neodvisno delovanje znanstvenih strokovnjakov.
English: For the purposes of Article 38(1)(c) and in order to ensure the efficient processing of requests to the Authority for a scientific output, standard data formats and software packages shall be adopted to allow documents to be submitted, searched, copied and printed, while ensuring compliance with regulatory requirements set out in Union food law.
Translation (en-sl): Za namene člena 38(1)(c) in za učinkovito obravnavo zaprosil agenciji za znanstveni prispevek se sprejmejo standardne oblike zapisa podatkov in paketi programske opreme, da se omogoči predložitev, kopiranje in tiskanje dokumentov ter iskanje po njih, hkrati pa zagotavlja skladnost z regulativnimi zahtevami iz živilske zakonodaje Unije.
English: (40) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council and delivered an opinion on […],
Translation (en-sl): (40) V skladu s členom 28(2) Uredbe (ES) št. 45/2001 Evropskega parlamenta in Sveta je bilo opravljeno posvetovanje z Evropskim nadzornikom za varstvo podatkov, ki je podal mnenje […] -
English: The possibility to ask the EFSA to exceptionally commission studies: This is an additional tool where scientific evidence upon which EFSA relies needs to be verified.
Translation (en-sl): Možnost, da se EFSA zaprosi, da izjemoma naroči študije: To je dodatno orodje, ki se lahko uporabi, kadar je treba preveriti znanstvene dokaze, na katere se EFSA opira.
English: The risk of duplicating with activities Member States carry out under OECD agreements is addressed since the Commission auditing programme will be complementary to and coordinated with OECD Good Laboratory Practices (GLP) auditing programmes, which currently audit each Member State monitoring authority every 10 years.
Translation (en-sl): Nevarnost, da bi prišlo do podvajanja z dejavnostmi, ki jih države članice izvajajo na podlagi sporazumov OECD, bo Komisija preprečila tako, da se bo njen program presoj dopolnjeval in usklajeval s programi OECD za presojo dobre laboratorijske prakse, v okviru katerih po sedanji ureditvi vsakih 10 let potekajo presoje nadzornega organa vsake države članice.
English: Members of the Management Board, the Executive Director, members of the Scientific Committee and Scientific Panels as well as external experts participating in their working groups, members of the Advisory Forum and members of the staff of the Authority, even after their duties have ceased, shall be subject to the requirements of confidentiality pursuant to Article 339 of the Treaty.
Translation (en-sl): Za člane upravnega odbora, izvršnega direktorja, člane znanstvenega odbora in znanstvenih svetov kakor tudi zunanje strokovnjake, ki sodelujejo v njihovih delovnih skupinah, člane posvetovalnega foruma in osebje agencije tudi po prenehanju opravljanja njihovih dolžnosti veljajo zahteve glede varovanja poslovnih skrivnosti v skladu s členom 339 Pogodbe.
English: The process to be followed for the processing of confidentiality claims is also set up.
Translation (en-sl): Prav tako je določen postopek za obravnavo zahtev za zaupnost.
English: EFSA Single Programming Document (SPD), EFSA Management Board meeting (responsible for Authority's governance), EFSA Annual report activities.
Translation (en-sl): Enotni programski dokument agencije EFSA, seja upravnega odbora agencije EFSA (odgovornega za upravljanje agencije EFSA), dejavnosti, povezane z letnim poročilom agencije EFSA.
English: As explained in the Explanatory Memorandum of the latter proposal, the Commission did not include in its horizontal alignment legislative proposal, amongst others, Regulation (EC) No 1935/2004, Regulation (EC) No 1331/2008 and Regulation (EC) No 1107/2009, as it is reflecting on whether there is a more appropriate way to structure these acts as concerns individual authorisations/setting of values/listing of specific substances based on the specific criteria set out in those acts, bearing in mind the improved approach adopted by the co-legislators in the context of Regulation (EU) 2015/2283 and the ongoing REFIT reviews of Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009.
Translation (en-sl): Kot je pojasnjeno v obrazložitvenem memorandumu tega predloga, Komisija v svoj zakonodajni predlog za horizontalno uskladitev med drugim ni vključila Uredbe (ES) št. 1935/2004, Uredbe (ES) št. 1331/2008 in Uredbe (ES) št. 1107/2009, saj želi preučiti, ali obstaja primernejše strukturiranje teh aktov v zvezi s posameznimi odobritvami / določitvami vrednosti / naštevanjem posameznih snovi na podlagi posebnih meril, določenih v navedenih aktih, ob upoštevanju izboljšanega pristopa, ki sta ga sozakonodajalca sprejela v Uredbi (EU) 2015/2283 in v tekočem pregledu Uredbe (ES) št. 1935/2004 in Uredbe (ES) št. 1107/2009 v okviru programa REFIT.
English: Notwithstanding paragraph 1, disclosure of names and addresses of natural persons involved in testing on vertebrate animals or in obtaining toxicological information shall be deemed to significantly harm the privacy and the integrity of those natural persons and shall not be made publicly available, unless there is an overriding public interest.
Translation (en-sl): Ne glede na odstavek 1 velja, da bi razkritje imen in naslovov fizičnih oseb, ki sodelujejo pri poskusih na vretenčarjih ali pridobivanju toksikoloških informacij, znatno ogrozilo zasebnost in integriteto navedenih fizičnih oseb, zato se navedeni podatki ne objavijo, razen če prevlada javni interes.
English: To this end, the proposal sets out a cross-sectoral list of information items whose disclosure might be considered to significantly harm the commercial interests at stake and should therefore not be disclosed to the public.
Translation (en-sl): V ta namen predlog določa medsektorski seznam informacij, katerih razkritje bi lahko znatno škodovalo zadevnim poslovnim interesom, zato se ne bi smele razkriti javnosti.
English: Consistency with existing policy provisions in the policy area
Translation (en-sl): Skladnost z veljavnimi predpisi s področja zadevne politike
English: The Commission shall without delay inform the Member States and forward the application to the European Food Safety Authority (hereinafter referred to as the Authority).
Translation (en-sl): Komisija takoj obvesti države članice in posreduje zahtevek Evropski agenciji za varnost hrane (v nadaljnjem besedilu: urad).