qanastek/ELRC-Medical-V2 huggingface dataset:
English: In particular, the new provisions provide that all supporting data and information relating to applications for authorisation are to be made public by EFSA upon receipt (as applications will be submitted either directly to EFSA or forwarded to EFSA by Member States or by the Commission), including supplementary information, except for duly justified confidentiality information.
Translation (en-sl): V novih določbah je zlasti določeno, da mora EFSA po prejemu (vloge se ji predložijo neposredno ali pa ji jih posredujejo države članice ali Komisija) objaviti vse podporne podatke in informacije v zvezi z vlogami odobritev, vključno z dodatnimi informacijami, razen v primeru ustrezno utemeljenih zaupnih informacij.
English: The Authority shall support the tasks of the Panels by organising their work, in particular the preparatory work to be undertaken by the Authority's staff or by designated national scientific organisations referred to in the Article 36 including by organising the possibility for preparing scientific opinions to be peer-reviewed by the Panels before they adopt them.
Translation (en-sl): Agencija podpira naloge znanstvenih svetov, tako da organizira njihovo delo, zlasti pripravljalno delo, ki ga izvaja osebje agencije ali imenovane nacionalne znanstvene organizacije iz člena 36, tudi z organiziranjem možnosti za pripravo znanstvenih mnenj, ki jih morajo znanstveni sveti strokovno pregledati, preden jih sprejmejo.
English: Evidence has pointed to occasional divergences and, in very few occasions, conflicting communications amongst Union and national risk assessors and risk managers, which may have an adverse impact on public perception as regards the assessment and management of risk related to the agri-food chain.
Translation (en-sl): Dokazana so bila občasna razhajanja v mnenjih in v zelo redkih primerih nasprotujoče si obveščanje med odgovornimi za oceno tveganja in odgovornimi za obvladovanje tveganja na ravni Unije ter med tistimi na nacionalni ravni, kar bi lahko negativno vplivalo na javno dojemanje ocenjevanja in obvladovanja tveganja v agroživilski verigi.
English: Amendments to Regulation (EC) 1831/2003 on feed additives
Translation (en-sl): Spremembe Uredbe (ES) 1831/2003 o krmnih dodatkih
English: (a) agendas and minutes of the Scientific Committee and the Scientific Panels and their Working Groups;
Translation (en-sl): (a) dnevne rede in zapisnike zasedanj znanstvenega odbora in znanstvenih svetov ter njihovih delovnih skupin;
English: Obligations with regard to confidentiality
Translation (en-sl): Obveznosti glede zaupnosti
English: (b) the competent authority shall assess the confidentiality request submitted by the notifier/applicant.
Translation (en-sl): (b) pristojni organ oceni zahtevo za zaupnost, ki jo je predložil prijavitelj/vlagatelj.
English: The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 of this Regulation shall start either on the Commission's initiative or following an application to the Commission by an applicant, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002.
Translation (en-sl): Postopek za odobritev dajanja novega živila na trg v Uniji ter posodobitev seznama Unije iz člena 9 te uredbe se začne na pobudo Komisije ali na podlagi vloge, ki jo vložnik predloži Komisiji v standardnih oblikah zapisa podatkov, če te obstajajo, v skladu s členom 39f Uredbe (ES) št. 178/2002.
English: This request shall be accompanied by verifiable justification demonstrating how making public the information concerned significantly harms the interests concerned in accordance with paragraphs 2 and 3 of Article 39.
Translation (en-sl): Temu zahtevku se priloži preverljiva utemeljitev, v kateri je prikazano, kako bi objava zadevnih informacij v skladu s členom 39(2) in (3) znatno škodovala zadevnim interesom.
English: (26) Where the opinion of the Authority is requested in relation to authorisation procedures under Union food law and having regard to its obligation to ensure public access to all supporting information with respect to the provision of its scientific outputs, the Authority should have responsibility for assessing confidentiality requests.
Translation (en-sl): (26) Kadar je Agencija zaprošena za mnenje v zvezi s postopki odobritve na podlagi živilske zakonodaje Unije, bi morala biti glede na svojo obveznost, da zagotovi javni dostop do vseh podpornih informacij v zvezi s pripravo znanstvenih prispevkov, odgovorna za ocenjevanje zahtev za zaupnost.
English: Review clause
Translation (en-sl): Klavzula ponovnega pregleda
English: To determine what level of disclosure strikes the appropriate balance, the public interest in ensuring greater transparency in the risk assessment process is weighted up against the commercial interests at stake.
Translation (en-sl): Da bi se ugotovilo, s katero stopnjo razkritja bi se doseglo primerno ravnovesje, se pretehtajo javni interes zagotavljanja večje preglednosti v postopku ocenjevanja tveganja ter zadevni poslovni interesi.
English: When the Authority identifies that specific expertise is missing in a Panel or several Panels, the Executive Director shall propose additional members of the Panel(s) for appointment to the Management Board in accordance with the procedure laid down in paragraph 5.
Translation (en-sl): Kadar agencija ugotovi, da v enem ali več znanstvenih svetih manjka posebno strokovno znanje, izvršni direktor upravnemu odboru predlaga imenovanje dodatnih članov znanstvenega sveta oziroma svetov v skladu s postopkom iz odstavka 5.
English: Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY
Translation (en-sl): trajanje predloga/pobude od [D. MMMM] LLLL do [D. MMMM] LLLL,
English: A decision to revoke shall put an end to the delegation of power specified in that decision.
Translation (en-sl): S sklepom o preklicu preneha veljati prenos pooblastila iz navedenega sklepa.
English: Amendments to Regulation (EC) No 1331/2008 on the common authorisation procedure for food additives, food enzymes and food flavourings
Translation (en-sl): Spremembe Uredbe (ES) št. 1331/2008 o skupnem postopku odobritve za aditive za živila, encime za živila in arome za živila
English: "The Authority shall ensure public access to the notification pursuant to Article 23.
Translation (en-sl): „Agencija v skladu s členom 23 zagotovi javni dostop do priglasitve.
English: SPECIFIC OBJECTIVE No 4 develop a more effective and transparent risk communication with the public in collaboration with Member States
Translation (en-sl): SPECIFIČNI CILJ št. 4 razviti učinkovitejše in preglednejše obveščanje javnosti o tveganju v sodelovanju z državami članicami
English: Risk assessment is defined as the scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation.
Translation (en-sl): Ocena tveganja je opredeljena kot postopek na znanstveni podlagi, sestavljen iz štirih korakov: prepoznavanja nevarnosti, opredelitve nevarnosti, ocene izpostavljenosti in opredelitve tveganja.
English: Strengthened analysis of social science survey analysis 0.500 0.875 1.250 1.250 1.250 5.125
Translation (en-sl): Okrepljena analiza: družboslovne raziskave, analize 0,500 0,875 1,250 1,250 1,250 5,125
English: Where an opinion by the Authority is not required in accordance with Article 3(2) of this Regulation, the Commission shall assess the confidentiality request submitted by the applicant.
Translation (en-sl): Kadar mnenje Agencije v skladu s členom 3(2) te uredbe ni potrebno, Komisija oceni zahtevo za zaupnost, ki jo je vložil predlagatelj.
English: SPECIFIC OBJECTIVE No 3 improve the governance, strengthen the involvement of Member States and address the limitations affecting the long term scientific capacity of EFSA
Translation (en-sl): SPECIFIČNI CILJ št. 3 izboljšati upravljanje, okrepiti vključenost držav članic ter odpraviti omejitve, ki vplivajo na dolgoročno znanstveno zmogljivost agencije EFSA
English: Officials (AD Grades)
Translation (en-sl): Uradniki (razredi AD)
English: Estimated impact on the staff (additional) - external personnel
Translation (en-sl): Ocenjene posledice za uslužbence (dodatno) - zunanji sodelavci
English: The proposal is expected to contribute to the Union risk assessment system acquiring greater legitimacy in the eyes of the Union consumers and general public, increasing their confidence in its outcome and ensure that it is more accountable to the Union citizens.
Translation (en-sl): Pričakuje se, da bo predlog prispeval k sistemu Unije za ocenjevanje tveganja, tako da bodo potrošniki in splošna javnost v Uniji v večji meri priznavali njegovo legitimnost, pri čemer se bo povečalo njihovo zaupanje v rezultate in zagotovilo, da bo sistem bolj odgovoren državljanom Unije.
English: Regulation (EU) No 2015/2283 is amended as follows:
Translation (en-sl): Uredba (EU) 2015/2283 se spremeni:
English: The specific obligations in the case of renewals of authorisations: The obligation to notify EFSA of planned studies and to systematically carry out consultation on these planned studies with the EFSA issuing systematic advice on the content of the intended application are expected to have a positive balance of effects.
Translation (en-sl): Posebne obveznosti v primeru obnovitev odobritev: Obveznosti obveščanja agencije EFSA o načrtovanih študijah ter sistematičnega posvetovanja o teh načrtovanih študijah, skupaj z izdajo sistematičnih mnenj agencije EFSA o vsebini predvidene vloge, naj bi imele pozitivne učinke.
English: Amendments to Regulation (EC) No 2065/2003 on smoke flavourings
Translation (en-sl): Spremembe Uredbe (ES) št. 2065/2003 o aromah dima
English: Additional ad hoc studies 16 ad hoc studies 6.000 10.500 15.000 15.000 15.000 61.500
Translation (en-sl): Dodatne študije ad hoc 16 študij ad hoc 6,000 10,500 15,000 15,000 15,000 61,500
English: This urgent proposal draws up from the findings of the Fitness Check of the GFL Regulation and is based on the commitments made by the Commission's reply to the ECI Communication.
Translation (en-sl): Ta nujni predlog temelji na ugotovitvah preverjanja ustreznosti uredbe o splošni živilski zakonodaji in na zavezah iz odgovora Komisije na evropsko državljansko pobudo.
English: (b) the following paragraphs 1a and 1b are inserted:
Translation (en-sl): (b) vstavita se naslednja odstavka 1a in 1b:
English: Regulation (EC) No 178/2002, Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003 and Regulation (EC) No 2065/2003 are currently included in the Commission's horizontal alignment legislative proposal adopted in 2016.
Translation (en-sl): Uredba (ES) št. 178/2002, Direktiva 2001/18/ES, Uredba (ES) št. 1829/2003, Uredba (ES) št. 1831/2003 in Uredba (ES) št. 2065/2003 so trenutno vključene v zakonodajni predlog Komisije za horizontalno uskladitev, sprejet leta 2016.
English: Where the Commission does not request the Authority's opinion pursuant to Articles 10 and 16, the Commission shall assess the confidentiality request submitted by the applicant.
Translation (en-sl): Kadar Komisija v skladu s členoma 10 in 16 Agencije ne zaprosi za mnenje, Komisija oceni zahtevo za zaupnost, ki jo je predložil vložnik.
English: NO YES
Translation (en-sl): /NE DA
English: There should be no negative impact for innovation from the measures on the reliability and robustness of studies.
Translation (en-sl): Ukrepi za zanesljivost in trdnost študij ne bi smeli negativno vplivati na inovacije.
English: Capacity building 2.4 FTEs 0.124 0.217 0.310
Translation (en-sl): Krepitev zmogljivosti 2,4 EPDČ 0,124 0,217 0,310
English: [27: Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers, (OJ L 55, 28.2.2011, p.
Translation (en-sl): [27: Uredba (EU) št. 182/2011 Evropskega parlamenta in Sveta z dne 16. februarja 2011 o določitvi splošnih pravil in načel, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije (UL L 55, 28.2.2011, str.
English: The general plan for risk communication shall promote an integrated risk communication framework to be followed both by the risk assessors and the risk managers in a coherent and systematic manner both at Union and national level.
Translation (en-sl): Splošni načrt obveščanja o tveganju spodbuja celosten okvir za obveščanje o tveganju, ki ga morajo dosledno in sistematično upoštevati odgovorni za oceno tveganja in odgovorni za obvladovanje tveganja na ravni Unije in na nacionalni ravni.
English: (24) The European Citizens' Initiative "Ban glyphosate and protect people and the environment from toxic pesticides" further confirmed concerns regarding transparency with respect to studies commissioned by the industry and submitted in authorisation application.
Translation (en-sl): (24) Evropska državljanska pobuda „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi" je dodatno potrdila pomisleke glede preglednosti v zvezi s študijami, ki jih naroča industrija in se predložijo vlogam za odobritev.
English: Temporary staff 4.861 8.507 12.154 12.154 12.154 49.830
Translation (en-sl): Začasni uslužbenci 4,861 8,507 12,154 12,154 12,154 49,830
English: 3) improve the governance, strengthen the involvement of Member States and address the limitations affecting the long term scientific capacity of EFSA taking also account of the related financial and budgetary aspects,
Translation (en-sl): 3) izboljšati upravljanje, okrepiti vključenost držav članic ter odpraviti omejitve, ki vplivajo na dolgoročno znanstveno zmogljivost agencije EFSA, pri čemer se upoštevajo tudi s tem povezani finančni in proračunski vidiki;
English: Subtotal for specific objective No 1 1.120 1.960 2.800 2.800 2.800 11.480
Translation (en-sl): Seštevek za specifični cilj št. 1 1,120 1,960 2,800 2,800 2,800 11,480
English: (6) To this effect, it is necessary to establish general objectives and principles of risk communication, taking into account the respective roles of risk assessors and managers.
Translation (en-sl): (6) V ta namen je treba določiti splošne cilje in načela obveščanja o tveganju, ob upoštevanju vloge odgovornih za oceno tveganja in odgovornih za obvladovanje tveganja.
English: On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether an authorisation for a product referred to in Article 15(1) still meets the conditions set by this Regulation.
Translation (en-sl): Agencija na lastno pobudo ali na zahtevo države članice ali Komisije da svoje mnenje o tem, ali odobritev za proizvod iz člena 15(1) še vedno izpolnjuje pogoje, določene s to uredbo.
English: (16) Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession.
Translation (en-sl): (16) Postopki odobritve temeljijo na načelu, da mora vlagatelj dokazati, da predmet postopka odobritve izpolnjuje varnostne zahteve Unije glede na znanstvena dognanja, s katerimi razpolaga.
English: In addition, unlike in the case of other Union Agencies, EFSA governance has not yet been brought in line with the Common Approach on Union decentralised agencies, including with regard to the composition of its Management Board.
Translation (en-sl): Poleg tega upravljanje agencije EFSA, v nasprotju z drugimi agencijami Unije, še ni usklajeno s skupnim pristopom k decentraliziranim agencijam Unije, tudi glede sestave upravnega odbora.
English: Additional ad hoc studies 4FTEs 0.207 0.362 0.517
Translation (en-sl): Dodatne študije ad hoc 4 EPDČ 0,207 0,362 0,517
English: (b) the Authority shall assess the confidentiality request submitted by the applicant.
Translation (en-sl): (b) Agencija oceni zahtevo za zaupnost, ki jo je predložil vlagatelj.
English: (b) the trademark under which the substance, shall be marketed as well as the tradename of the preparations, material or articles in which it shall be used, where applicable; and,
Translation (en-sl): (b) blagovne znamke, pod katero se snov trži, ter, kadar je to ustrezno, trgovskega imena pripravkov, materialov ali izdelkov, v katerih se snov uporablja; ter
English: It will also address the findings of the GFL Fitness Check that identified challenges to EFSA's capacity to maintain its high level of scientific expertise by providing for an increased involvement of Member States in the nomination process of Panels' members.
Translation (en-sl): Obravnaval bo tudi ugotovitve preverjanja ustreznosti splošne živilske zakonodaje, pri katerem so bili opredeljeni izzivi v zvezi z zmogljivostjo agencije EFSA za ohranjanje visoke ravni strokovnega znanja s povečano vključenostjo držav članic v postopek imenovanja članov znanstvenih svetov.
English: Risk assessment at Union level is carried out by an autonomous agency established by the GFL Regulation, the European Food Safety Authority (EFSA), separately from the risk management function of the Union Institutions, and mainly that of the Commission.
Translation (en-sl): Evropska agencija za varnost hrane (EFSA), ustanovljena z uredbo o splošni živilski zakonodaji, in sicer ločeno od naloge obvladovanja tveganja, ki jo opravljajo institucije Unije, zlasti Komisija.
English: Estimated impact on EFSA expenditure
Translation (en-sl): Ocenjene posledice za odhodke EFSA
English: "Article 39
Translation (en-sl): „Člen 39
English: Capacity building 10 panels/21 members 7 days/training /y 0.224 0.392 0.560 0.560 0.560 2.296
Translation (en-sl): Krepitev zmogljivosti 10 svetov/21 članov 7 dni usposabljanja/leto 0,224 0,392 0,560 0,560 0,560 2,296
English: It is also proportionate given that the applicant can get useful advice on the content of its intended application following the consultation on the planned studies and this at an early stage of the process.
Translation (en-sl): Poleg tega je tudi sorazmerno, saj lahko vlagatelj v posvetovanju o načrtovanih študijah že v zgodnji fazi postopka pridobi koristne nasvete o vsebini predvidene vloge.
English: The Authority shall lay down in its internal rules the practical arrangements for implementing the confidentiality rules laid down in Articles 39, 39a, 39b, 39e and this Article, including arrangements concerning the submission and treatment of confidentiality requests with respect to information to be made public under Article 38, and taking into account Articles 39f and 39g.
Translation (en-sl): Agencija v svojem poslovniku določi praktično ureditev za izvajanje pravil o zaupnosti iz členov 39, 39a, 39b, 39e in tega člena, vključno z ureditvijo glede vložitve in obravnavanja zahtev za zaupnost v zvezi z informacijami, ki jih je treba objaviti v skladu s členom 38, ter ob upoštevanju členov 39f in 39 g.";
English: [Heading……………………...…………] Diff./Non-diff.[44: Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.]
Translation (en-sl): [44: Dif. = diferencirana sredstva / nedif.
English: [16: Commission Staff Working Document, Synopsis Report, SWD(2018)97, [dated 11.04.2018].]
Translation (en-sl): [16: Delovni dokument služb Komisije, Zbirno poročilo, SWD(2018) 97, [z dne 11. 4.
English: On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether an authorisation for a product referred to in Article 3(1) still meets the conditions set by this Regulation.
Translation (en-sl): Agencija na lastno pobudo ali na zahtevo države članice ali Komisije da svoje mnenje o tem, ali odobritev za proizvod iz člena 3(1) še vedno izpolnjuje pogoje, določene s to uredbo.
English: Business operators shall notify, without delay, to the Authority the subject matter of any study commissioned to support a future application for an authorisation under Union food law.
Translation (en-sl): Nosilci dejavnosti morajo agencijo nemudoma uradno obvestiti o predmetu katere koli študije, naročene v podporo prihodnji vlogi za odobritev na podlagi živilske zakonodaje Unije.
English: Consultation of third parties
Translation (en-sl): Posvetovanje s tretjimi osebami
English: Contract staff 0.629 1.101 1.572 1.572 1.572 6.446
Translation (en-sl): Pogodbeni uslužbenci 0,629 1,101 1,572 1,572 1,572 6,446
English: Finally, the proposal introduces the possibility for the Commission to request EFSA to commission studies in exceptional circumstances (e.g. controversies) for the purpose of verification.
Translation (en-sl): Nazadnje, predlog uvaja možnost, da Komisija v izjemnih okoliščinah (npr. v primeru polemik) od agencije EFSA zahteva, da naroči študije z namenom preverjanja.
English: Register of commissioned studies Development & run 0.160 0.280 0.400 0.400 0.400 1.640
Translation (en-sl): Register naročenih študij Razvoj in upravljanje 0,160 0,280 0,400 0,400 0,400 1,640
English: (35) For the purposes of ensuring transparency of the risk assessment process, it is also necessary to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also cover applications for authorisations in the context of Regulation (EC) No 1831/2003 as regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and Regulation (EC) No 1107/2009 as regards plant protection products.
Translation (en-sl): (35) Za zagotovitev preglednosti postopka ocenjevanja tveganja je prav tako treba razširiti področje uporabe Uredbe (ES) št. 178/2002, ki je trenutno omejeno na živilsko zakonodajo, da se vanj vključijo tudi zahtevki za dovoljenje v okviru Uredbe (ES) št. 1831/2003 v zvezi s krmnimi dodatki, vloge za odobritev v okviru Uredbe (ES) št. 1935/2004 v zvezi z materiali, namenjenimi za stik z živili, in vloge za registracijo v okviru Uredbe (ES) št. 1107/2009 v zvezi s fitofarmacevtskimi sredstvi.
English: In particular, the Authority should organise the preparatory work supporting the Panels' tasks, including by requesting the Authority's staff or national scientific organisations networking with the Authority to draft preparatory scientific opinions to be peer-reviewed and adopted by the Panels.
Translation (en-sl): Agencija bi zlasti morala organizirati pripravljalno delo v podporo nalogam, ki jih opravljajo znanstveni sveti, tudi tako, da od osebja Agencije ali nacionalnih znanstvenih organizacij, ki se povezujejo z Agencijo, zahteva, da pripravijo osnutek pripravljalnih znanstvenih mnenj, za katere bo opravljen medsebojni strokovni pregled in ki jih bodo sprejeli znanstveni sveti.
English: Estimated impact on EFSA revenue
Translation (en-sl): Ocenjene posledice za prihodke EFSA
English: 4) develop a more effective and transparent risk communication with the public in collaboration with Member States]
Translation (en-sl): 4) razviti učinkovitejše in preglednejše obveščanje javnosti o tveganju v sodelovanju z državami članicami.]
English: XThe proposal/initiative relates to an action redirected towards a new action
Translation (en-sl): XPredlog/pobuda se nanaša na obstoječ ukrep, preusmerjen v nov ukrep.
English: The general plan should identify the key factors that need to be taken into account when considering the type and level of communication activities needed, ascertain the tools and channels for the relevant risk communication initiatives taking into account the relevant target audience groups; and, establish appropriate mechanisms to ensure coherent risk communication.
Translation (en-sl): V splošnem načrtu bi bilo treba opredeliti ključne dejavnike, ki jih je treba upoštevati pri določanju vrste in ravni potrebnih dejavnosti obveščanja, opredeliti orodja in kanale za ustrezne pobude obveščanja o tveganju, pri čemer se upoštevajo zadevne ciljne skupine, in vzpostaviti ustrezne mehanizme za zagotovitev usklajenega obveščanja o tveganju.
English: Stakeholders engagement in RA process 12.5 FTES 0.646 1.131 1.615
Translation (en-sl): Sodelovanje zainteresiranih strani v postopku ocenjevanja tveganja 12,5 EPDČ 0,646 1,131 1,615