FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: ][32: Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p.
Slovenian: ][32: Uredba Evropskega parlamenta in Sveta (ES) št. 1935/2004 z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili, in o razveljavitvi direktiv 80/590/EGS in 89/109/EGS (UL L 338, 13.11.2004, str.
English: The impact for innovation (divulging business strategy) is not significant for the notification of planned studies in case of renewals since the substance is already known and the date of renewal is set up in legislation The pre-submission procedure will help the SME's access to innovation and is at the request of the applicant except for renewals which represent a specific case and a limited number of applications.
Slovenian: Postopek pred vložitvijo vloge bo MSP olajšal dostop do inovacij in se uvede na zahtevo vlagatelja, razen za obnovitve, ki so poseben primer in zadevajo omejeno število vlog.
English: Article 32b
Slovenian: Člen 32b
English: Article 32e
Slovenian: Člen 32e
English: Article 39e
Slovenian: Člen 39e
English: "(l) an identification of the parts of the application and any other supplementary information that the applicant requests to be kept confidential, accompanied by verifiable justification, pursuant to Articles 30 of this Regulation and Article 39 of Regulation (EC) No 178/2002; ";
Slovenian: „(l) opredelitev delov vloge in vseh drugih dodatnih informacij, za katere vlagatelj v skladu s členom 30 te uredbe in členom 39 Uredbe (ES) št. 178/2002 zahteva, da se obravnavajo zaupno, pri čemer priloži preverljivo utemeljitev; ";
English: Proposal for a Regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283 [on novel foods.
Slovenian: Predlog Uredbe Evropskega parlamenta in Sveta o preglednosti in trajnosti ocenjevanja tveganja v prehranski verigi v EU ter o spremembah Uredbe (ES) št. 178/2002 [o splošni živilski zakonodaji], Direktive 2001/18/ES [o namernem sproščanju gensko spremenjenih organizmov v okolje], Uredbe (ES) št. 1829/2003 [o gensko spremenjenih živilih in krmi], Uredbe (ES) št. 1831/2003 [o krmnih dodatkih], Uredbe (ES) št. 2065/2003 [o aromah dima], Uredbe (ES) št. 1935/2004 [o materialih, namenjenih za stik z živili], Uredbe (ES) št. 1331/2008 [o skupnem postopku odobritve za aditive za živila, encime za živila in arome za živila], Uredbe (ES) št. 1107/2009 [o fitofarmacevtskih sredstvih] in Uredbe (EU) 2015/2283 [o novih živilih].
English: Article 32d
Slovenian: Člen 32d
English: executive agencies
Slovenian: prek izvajalskih agencij.
English: TOTAL COST 19.512 34.145 48.779 48.779 48.779 199.994
Slovenian: STROŠKI SKUPAJ 19,512 34,145 48,779 48,779 48,779 199,994
English: (6) in Article 18, paragraph 7 is replaced by the following:
Slovenian: (6) v členu 18 se odstavek 7 nadomesti z naslednjim:
English: ][9: Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p.
Slovenian: ][9: Uredba Evropskega parlamenta in Sveta (ES) št. 1935/2004 z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili, in o razveljavitvi direktiv 80/590/EGS in 89/109/EGS (UL L 338, 13.11.2004, str.
English: increase the guarantees of reliability, objectivity and independence of studies used by EFSA in its risk assessment for authorisation purposes
Slovenian: SPECIFIČNI CILJ št. 2 povečati jamstva glede zanesljivosti, objektivnosti in neodvisnosti študij, ki jih EFSA uporabi v svojih ocenah tveganja za namene odobritve
English: (4) in Article 11(2), the introductory sentence is replaced by the following:
Slovenian: (4) v členu 11(2) se uvodni stavek nadomesti z naslednjim:
English: Regulation (EC) No 1831/2003 is amended as follows:
Slovenian: Uredba (ES) št. 1831/2003 se spremeni:
English: (a) in paragraph 3 the introductory sentence is replaced by the following:
Slovenian: (a) v odstavku 3 se uvodni stavek nadomesti z naslednjim:
English: Article 39c
Slovenian: Člen 39c
English: (2) in Article 6, paragraph 7 is replaced by the following:
Slovenian: (2) v členu 6 se odstavek 7 nadomesti z naslednjim:
English: (d) the second subparagraph of paragraph 5 is replaced by the following:
Slovenian: (d) drugi pododstavek odstavka 5 se nadomesti z naslednjim:
English: Article 39b
Slovenian: Člen 39b
English: For consistency, the Commission proposal would also amend other sectoral food legislation.
Slovenian: Zaradi skladnosti bi predlog Komisije spremenil tudi drugo sektorsko živilsko zakonodajo.
English: Targeted consultations with specific stakeholder groups also took place.
Slovenian: Opravljena so bila tudi ciljno usmerjena posvetovanja s posebnimi skupinami zainteresiranih strani.
English: They also highlighted the need to ensure that the Commission proposal strengthens these elements while safeguarding the principles on which the EU food safety system is based.
Slovenian: Poudarili so tudi potrebo po zagotovitvi, da predlog Komisije okrepi te elemente in hkrati ohrani načela, na katerih temelji sistem EU za varnost hrane.
English: Capacity for more public resources to finance studies on food safety.
Slovenian: Zmogljivost za več javnih sredstev za financiranje študij o varnosti hrane.
English: Some MS expressed reservations on the potential added value of this measure.
Slovenian: Nekatere države članice so izrazile zadržke glede možne dodane vrednosti tega ukrepa.
English: Scientific independence and excellence of experts are cornerstones of the EU risk assessment system.
Slovenian: Znanstvena neodvisnost in odličnost strokovnjakov sta temelja sistema EU za ocenjevanje tveganja.
English: Sustainability of the risk assessment system and involvement of MS
Slovenian: Trajnost sistema ocenjevanja tveganja in vključenost držav članic
English: Need to ensure the protection of confidential data and personal data.
Slovenian: Potreba po zagotovitvi varstva zaupnih podatkov in varstva osebnih podatkov.
English: The information that EFSA makes public on its activities and contributions was also judged as very important.
Slovenian: Tudi informacije, ki jih EFSA objavi o svojih dejavnostih in prispevkih, so bile ocenjene kot zelo pomembne.
English: Risk communication on food safety can be further strengthened by improving coordination and involving relevant stakeholders.
Slovenian: Obveščanje o tveganju glede varnosti hrane je mogoče dodatno okrepiti z izboljšanjem usklajevanja in vključitvijo zadevnih zainteresiranih strani.
English: The Commission proposal would amend Regulation (EC) No 178/2002 which sets out the general principles and requirements of food law, establishing the European Food Safety Authority (EFSA) and defines procedures in matters of food safety.
Slovenian: Predlog Komisije bi spremenil Uredbo (ES) št. 178/2002, ki določa splošna načela in zahteve živilske zakonodaje, ustanavlja Evropsko agencijo za varnost hrane (EFSA) in določa postopke, ki zadevajo varnost hrane.
English: 18 of the stakeholders had also provided feedback on the roadmap.
Slovenian: 18 zainteresiranih strani je prav tako podalo povratne informacije o časovnem načrtu.
English: Safeguarding confidentiality and intellectual property rights is fundamental in order to avoid hampering innovation and competitiveness.
Slovenian: Zagotavljanje zaupnosti in varovanje pravic intelektualne lastnine sta bistvenega pomena za izogibanje oviram za inovacije in konkurenčnost.
English: There was a similar response from the stakeholder group.
Slovenian: Odziv skupine zainteresiranih strani je bil podoben.
English: Feedback received during the consultations was not taken into account if it went beyond the scope of the Commission proposal.
Slovenian: Povratne informacije, prejete med posvetovanji, niso bile upoštevane, če so presegale področje uporabe predloga Komisije.
English: The contributions to the different consultations showed a need to consider the following when preparing the Commission proposal:
Slovenian: Prispevki v okviru različnih posvetovanj so pokazali, da je treba pri pripravi predloga Komisije upoštevati naslednje:
English: MS acknowledged the need for more coordination among all actors.
Slovenian: Države članice so potrdile potrebo po večji usklajenosti vseh akterjev.
English: The latter also highlighted the need to ensure the independence of EFSA's scientific processes.
Slovenian: Slednji so prav tako poudarili potrebo po zagotavljanju neodvisnosti znanstvenih postopkov agencije EFSA.
English: The latter also highlighted the potential negative impact on competitiveness and innovation, in particular on new substances due to risks relating to potential unfair use of disclosed data and concerns over intellectual property rights.
Slovenian: Slednji so prav tako poudarili morebiten negativni učinek na konkurenčnost in inovacije, zlasti na nove snovi, zaradi tveganj v zvezi z morebitno nepošteno uporabo razkritih podatkov in pomislekov glede pravic intelektualne lastnine.
English: The earlier the access to industry studies in the risk assessment process, the greater its impact on transparency.
Slovenian: Čim hitrejši je dostop do študij industrije v postopku ocenjevanja tveganja, tem večji je njegov učinek na preglednost.
English: Industry stakeholders also highlighted the need to avoid unfair use of commercial data.
Slovenian: Zainteresirane strani iz industrije so prav tako poudarile potrebo po preprečevanju nepoštene uporabe poslovnih podatkov.
English: Evidence from industry studies
Slovenian: Dokazi iz študij industrije
English: Conclusions
Slovenian: Sklepi
English: The Commission proposal builds on the findings of the Fitness Check of the General Food Law and follows the Commission Communication on the European Citizens' Initiative to "Ban glyphosate and protect people and the environment from toxic pesticides".
Slovenian: Predlog Komisije temelji na ugotovitvah preverjanja ustreznosti splošne živilske zakonodaje in sledi sporočilu Komisije o evropski državljanski pobudi z naslovom „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi".
English: Regarding the establishment of a register of industry studies, mainly MS authorities highlighted the challenges as regards applicability outside the EU.
Slovenian: Kar zadeva vzpostavitev registra študij industrije, so predvsem organi držav članic poudarili izzive glede uporabe zunaj EU.
English: Consultations also took place via the EFSA Advisory Forum (national food safety authorities) and the Commission Expert Group on General Food Law and with the Scientific Committee of EFSA.
Slovenian: Opravljena so bila tudi posvetovanja v okviru posvetovalnega foruma agencije EFSA (z nacionalnimi organi za varnost hrane) in strokovne skupine Komisije o splošni živilski zakonodaji ter z znanstvenim odborom agencije EFSA.
English: Transparency of industry studies
Slovenian: Preglednost študij industrije
English: A letter of the European Ombudsman to the President of the European Commission on ensuring the EU risk assessment model in the food chain is independent, transparent, and allows for meaningful stakeholder engagement, was also considered.
Slovenian: Upoštevano je bilo tudi pismo evropskega varuha človekovih pravic predsedniku Evropske komisije o zagotavljanju modela EU za ocenjevanje tveganja v prehranski verigi, ki je neodvisen, pregleden in omogoča smiselno sodelovanje zainteresiranih strani.
English: Some citizens highlighted the need to avoid complexity and/or confusion in risk communication, and recommended making it clearer and simpler.
Slovenian: Nekateri državljani so poudarili, da se je treba izogniti zapletenosti in/ali zmedi v zvezi z obveščanjem o tveganju, in predlagali, da postane jasnejše in enostavnejše.
English: This was followed by an open public consultation (OPC), targeting citizens and stakeholders, open from 23 January 2018 to 20 March 2018.
Slovenian: Temu je sledilo odprto javno posvetovanje z državljani in zainteresiranimi stranmi, ki je potekalo od 23. januarja 2018 do 20. marca 2018.
English: This report covers feedback from citizens and national authorities, groups and organisations (‘stakeholders') as regards the initiative for a Commission proposal for a Regulation on the transparency and sustainability of the EU risk assessment in the food chain (‘Commission proposal').
Slovenian: To poročilo zajema povratne informacije državljanov in nacionalnih organov ter skupin in organizacij („zainteresirane strani") v zvezi s pobudo o predlogu Komisije za uredbo o preglednosti in trajnosti ocenjevanja tveganja v prehranski verigi v EU („predlog Komisije").
English: Industry organisations commented that there is a risk of the published data being misuse.
Slovenian: Industrijske organizacije so pripomnile, da obstaja tveganje zlorabe objavljenih podatkov.
English: As regards the financing of these verification studies, a small percentage of both citizens and stakeholders considered that the costs should be covered by the individual applicant concerned.
Slovenian: Glede financiranja teh preveritvenih študij je majhen delež sodelujočih državljanov in zainteresiranih strani menil, da bi stroške moral kriti posamezni vlagatelj.
English: Although, in general, stakeholders showed similar views, some saw certain measures as having different levels of importance.
Slovenian: Čeprav so v splošnem zainteresirane skupine izrazile podobna stališča, so se določeni ukrepi nekaterim zdeli različno pomembni.
English: EU-level stakeholder organisations representing farmers, cooperatives, the food industry, retailers, consumers, professionals and civil society were consulted in a working group meeting of the Advisory Group on the Food Chain and Animal and Plant Health.
Slovenian: Posvetovanja z organizacijami zainteresiranih strani na ravni EU, ki zastopajo kmete, zadruge, živilsko industrijo, trgovce na drobno, potrošnike, strokovnjake in civilno družbo, so potekala na sestanku svetovalne skupine za prehranjevalno verigo ter zdravje živali in rastlin.
English: [4: https://ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-chain_en ]
Slovenian: [4: https://ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-chain_sl. ]
English: Risk Communication
Slovenian: Obveščanje o tveganju
English: MS authorities also considered the importance of defining clear roles for the Management Board to avoid duplication with EFSA's Advisory Forum.
Slovenian: Organi držav članic so omenili tudi pomembnost določitve jasnih nalog upravnega odbora, da bi se izognili podvajanju dela s posvetovalnim forumom agencije EFSA.
English: As regards the citizens who took part, 318 replies came from 26 MS, 10 came from a European Free Trade Association country and five from other non-EU countries.
Slovenian: Kar zadeva državljane, ki so sodelovali v posvetovanju, pa je bilo prejetih 318 odgovorov iz 26 držav članic, 10 odgovorov iz držav Evropskega združenja za prosto trgovino in pet odgovorov iz drugih držav, ki niso članice EU.
English: Some NGOs and EFSA's Scientific Committee supported the added value of more public resources dedicated to food safety studies.
Slovenian: Nekatere nevladne organizacije in znanstveni odbor agencije EFSA so podprli dodano vrednost dodelitve več javnih sredstev za študije o varnosti hrane.
English: In general, industry stakeholders state that the timing of publication could have a negative or very negative impact on competitiveness, in particular if publication happens early in the assessment process.
Slovenian: Na splošno so zainteresirane strani iz industrije navedle, da bi imel časovni okvir objavljanja lahko negativen ali zelo negativen učinek na konkurenčnost, zlasti v primeru objave zgodaj v postopku ocenjevanja.
English: There is an exception to this in the stakeholder group of respondents: some NGOs (23.5 % of replies from stakeholders) do not consider that including general principles of risk communication in legislation would be very effective.
Slovenian: Vendar v skupini zainteresiranih strani obstaja izjema: nekatere nevladne organizacije (23,5 % odgovorov) menijo, da vključitev splošnih načel obveščanja o tveganju v zakonodajo ne bi bila zelo učinkovita.
English: For respondents from the stakeholder group, these percentages were 47.7 %, 21.6 % and 9.2 %, respectively.
Slovenian: V primeru sodelujočih zainteresiranih strani so ti deleži znašali 47,7 %, 21,6 % oziroma 9,2 %.
English: The stakeholders that took part represented a variety of sectors: trade and business associations (39.22 %), companies and groups (14.38 %), NGOs (13.07 %), professional associations (8.5 %), national/regional authorities (8.5 %), governmental agencies (5.23 %), research institutes (3.92 %), public bodies (1.96 %), professional consultancies (1.96 %), think-tanks (1.31 %), law firms (0.65 %), EU Institutions (0.65 %), and other (0.65 %).
Slovenian: Zainteresirane strani, ki so sodelovale v posvetovanju, zastopajo različne sektorje: trgovinska in poslovna združenja (39,22 %), družbe in skupine (14,38 %), nevladne organizacije (13,07 %), poklicna združenja (8,5 %), nacionalne/regionalne organe (8,5 %), vladne agencije (5,23 %), raziskovalne inštitute (3,92 %), javne organe (1,96 %), poklicne svetovalne službe (1,96 %), možganske truste (1,31 %), odvetniške pisarne (0,65 %), institucije EU (0,65 %) in druge (0,65 %).
English: As consumers may in general lack the scientific knowledge to use these studies, consumer organisations suggested that trust would depend on other factors, e.g. third-party scrutiny of the studies.
Slovenian: Ker potrošniki na splošno morda nimajo dovolj strokovnega znanja, da bi uporabili te študije, bi po mnenju združenj potrošnikov zaupanje temeljilo na drugih dejavnikih, npr. na pregledu študij s strani tretjih oseb.
English: Some citizens and stakeholders (including MS authorities) highlighted the need to clearly separate risk assessment and risk management and suggested having representation from other stakeholder groups as well.
Slovenian: Nekateri državljani in zainteresirane strani (vključno z organi držav članic) so poudarili potrebo po jasnem ločevanju med ocenjevanjem in obvladovanjem tveganja ter predlagali, da bi bile zastopane tudi druge skupine zainteresiranih strani.
English: Furthermore, about 35 % of replies from stakeholders, in this case mainly industry organisations, state that publishing industry studies will be negative or very negative for both competitiveness and promoting innovation.
Slovenian: Približno 35 % sodelujočih zainteresiranih strani, v tem primeru zlasti industrijske organizacije, pa je odgovorilo, da bo objavljanje študij industrije negativno ali zelo negativno tako za konkurenčnost kot za spodbujanje inovacij.
English: Adequate incentives are needed in order to ensure that EFSA obtains the expertise it needs from MS.
Slovenian: Potrebne so ustrezne spodbude, da agencija EFSA iz držav članic lahko dobi strokovno znanje, ki ga potrebuje.
English: Need to tackle potential negative impacts of consultations on studies submitted on the length of the assessment processes.
Slovenian: Potreba po obravnavanju morebitnih negativnih učinkov posvetovanj o predloženih študijah na trajanje postopka ocenjevanja.
English: Overall, in their replies citizens and stakeholders expressed the importance of the elements addressed by the Commission initiative to improve the EU risk assessment in the food chain.
Slovenian: Na splošno so državljani in zainteresirane strani v svojih odgovorih izrazili pomembnost elementov, ki jih obravnava pobuda Komisije, za izboljšanje ocenjevanja tveganja v prehranski verigi v EU.
English: Overall, all consulted parties acknowledged the value of the actions aiming to improve risk communication.
Slovenian: Na splošno so vse strani, ki so sodelovale v posvetovanju, potrdile vrednost ukrepov za izboljšanje obveščanja o tveganju.
English: There were different views on the timing of publishing non-confidential parts of industry studies throughout the risk assessment process and the impact on transparency.
Slovenian: Obstajajo različna mnenja glede časovnega okvira za objavo nezaupnih delov študij industrije v celotnem postopku ocenjevanja tveganja in glede učinka na preglednost.
English: Although this was in general welcomed, some MS authorities and industry stakeholders mentioned the potential negative impact on the length of EFSA's risk assessment processes.
Slovenian: Čeprav je bilo to na splošno dobro sprejeto, so organi nekaterih držav članic in zainteresirane strani iz industrije omenile morebiten negativni učinek na trajanje postopkov ocenjevanja tveganja agencije EFSA.
English: Discussions with stakeholders highlighted the potential for establishing procedures for open consultations on data related to the studies submitted by industry as part of authorisation dossiers.
Slovenian: V razpravah z zainteresiranimi stranmi je bila poudarjena možnost za uvedbo postopkov za odprta posvetovanja o podatkih v zvezi s študijami, ki jih predloži industrija kot del dokumentacije za pridobitev odobritve.
English: In the OPC, over a third of citizens consider that existing risk communication does not contribute very much or at all to building trust in the EU's decision-making process in the food chain.
Slovenian: Več kot tretjina sodelujočih državljanov je menila, da obstoječe obveščanje o tveganju le malo ali pa sploh ne prispeva h krepitvi zaupanja v postopek odločanja EU v prehranski verigi.
English: In addition, both citizens (75.2 %) and stakeholders (79.7 %) agree or strongly agree that the costs of national bodies' scientific contribution to EFSA's tasks should be adequately compensated.
Slovenian: Poleg tega so se sodelujoči državljani (75,2 %) in zainteresirane strani (79,7 %) strinjali ali zelo strinjali, da bi morali biti stroški znanstvenega prispevka nacionalnih organov k nalogam agencije EFSA ustrezno povrnjeni.
English: The OPC received replies from 471 participants: 318 citizens and 153 stakeholders.
Slovenian: V navedenem posvetovanju je svoje odgovore podalo 471 sodelujočih: 318 državljanov in 153 zainteresiranih strani.
English: The other financing options proposed, i.e. the EU budget, common funding provided by all industry applicants or a combination of public and industry funding, were considered relevant by 32.1 %, 27 % and 25.2 % of citizens, respectively.
Slovenian: Druge predlagane možnosti financiranja, tj. financiranje iz proračuna EU, skupno financiranje s strani vseh vlagateljev iz industrije ali kombinacija financiranja s strani javnega sektorja in industrije, so pomembne po mnenju 32,1 %, 27 % oziroma 25,2 % sodelujočih državljanov.
English: Citizens and stakeholders acknowledged the importance of public access to the industry studies used by EFSA in its risk assessments, with the exception of the business secrets and other confidential information, as a significant element of ensuring trust in the EU's food safety risk assessment.
Slovenian: Državljani in zainteresirane strani so potrdili pomembnost javnega dostopa do študij industrije, ki jih EFSA uporabi v svojih ocenah tveganja, z izjemo poslovnih skrivnosti in drugih zaupnih informacij, kot pomemben del zagotavljanja zaupanja v ocenjevanje tveganja v zvezi z varnostjo hrane v EU.
English: Further involvement of MS authorities in EFSA's activities must continue to ensure the separation between risk assessment and risk management.
Slovenian: Potrebno je nadaljnje vključevanje organov držav članic v dejavnosti agencije EFSA, da se zagotovi ločevanje med ocenjevanjem in upravljanjem tveganja.
English: Some MS authorities highlighted the need to ensure a proper balance between EFSA's independence policies and its links with scientific excellence, and the need to consider incentives to stimulate the contribution of MS experts to EFSA's work, including financial and non-financial elements.
Slovenian: Organi nekaterih držav članic so poudarili potrebo po zagotovitvi ustreznega ravnotežja med politikami neodvisnosti agencije EFSA in njeno povezavo z znanstveno odličnostjo ter potrebo po obravnavanju spodbud za večje prispevanje strokovnjakov držav članic k delu agencije EFSA, vključno s finančnimi in nefinančnimi elementi.
English: Some comments from MS authorities reflect on the need to specify what should be considered confidential in legislation.
Slovenian: Nekatere pripombe organov držav članic se nanašajo na potrebo, da se določi, katere elemente bi bilo treba obravnavati kot zaupne v zakonodaji.
English: Details on what information from industry studies can be claimed as confidential need to be clear, and the related claims must be thoroughly assessed.
Slovenian: Podrobnosti o informacijah iz študij industrije, za katere se lahko zahteva zaupnost, morajo biti jasne, s tem povezane zahteve pa temeljito ocenjene.
English: Some MS authorities and industry stakeholders considered that it may have a detrimental impact on EU innovation.
Slovenian: Organi nekaterih držav članic in zainteresirane strani iz industrije so menili, da lahko škodljivo vplivajo na inovacije v EU.
English: Consumer organisations commented on the need to clearly explain the political choices made and improve the MS involvement in risk communication.
Slovenian: Združenja potrošnikov so izrazila pripombe glede potrebe po jasnih obrazložitvah sprejetih političnih odločitev in izboljšanju sodelovanja držav članic pri obveščanju o tveganju.
English: Need for proportionate verification processes on the quality of industry studies as regards compliance with relevant standards.
Slovenian: Potreba po sorazmernih postopkih za preverjanje kakovosti študij industrije v zvezi s skladnostjo z ustreznimi standardi.
English: Synopsis report
Slovenian: Zbirno poročilo
English: Avoiding scientific divergences between the EU and national levels was considered to be useful or very useful by 72.3 % of respondents from the citizen group; this equals 79.1 % for the stakeholder group.
Slovenian: Izogibanje znanstvenim razhajanjem med ravnjo EU in nacionalnimi ravnmi se zdi koristno ali zelo koristno 72,3 % sodelujočim iz skupine državljanov; za skupino zainteresiranih strani pa ta delež znaša 79,1 %.
English: As regards MS being represented in EFSA's Management Board, 57.5 % of citizens and 53.6 % of stakeholders agreed or strongly agreed.
Slovenian: Kar zadeva države članice, zastopane v upravnem odboru agencije EFSA, se je 57,5 % sodelujočih državljanov in 53,6 % sodelujočih zainteresiranih strani strinjalo ali zelo strinjalo s tem.
English: Some MS, industry stakeholders, NGOs including consumer associations, and EFSA's Scientific Committee stressed that cooperation with MS needs to respect the independence of the experts in their contribution to EFSA and the separation between risk assessment and risk management.
Slovenian: Nekatere države članice, zainteresirane strani iz industrije, nevladne organizacije, vključno z združenji potrošnikov, in znanstveni odbor agencije EFSA so poudarili, da je treba pri sodelovanju z državami članicami spoštovati neodvisnost strokovnjakov pri njihovem prispevanju k agenciji EFSA ter ločevanje med ocenjevanjem in obvladovanjem tveganja.
English: Most citizens and stakeholders found important or very important the elements currently in place to ensure that the studies provided by industry are sufficiently robust to serve EFSA's risk assessment needs.
Slovenian: Za večino sodelujočih državljanov in zainteresiranih strani je pomembno ali zelo pomembno, da elementi, ki se trenutno uporabljajo, zagotavljajo, da so študije industrije dovolj zanesljive za potrebe ocenjevanja tveganja, ki ga opravlja agencija EFSA.
English: NGOs commented on the need to review the validity of the confidentiality claims made in relation to industry studies.
Slovenian: Nevladne organizacije so izrazile pripombe glede potrebe po pregledu veljavnosti zahtev za zaupnost v zvezi s študijami industrije.
English: As regards the impact of publishing industry studies, 42.1 % of citizen replies and 21.6 % of stakeholder replies state that it is important or very important for competitiveness; 56.3 % of citizen replies and 31.4 % of stakeholder replies state that it is positive or very positive for innovation.
Slovenian: Kar zadeva učinek objavljanja študij industrije, je 42,1 % sodelujočih državljanov in 21,6 % sodelujočih zainteresiranih strani odgovorilo, da je pomembno ali zelo pomembno za konkurenčnost; 56,3 % sodelujočih državljanov in 31,4 % sodelujočih zainteresiranih je navedlo, da je pozitivno ali zelo pozitivno za inovacije.
English: Potential value of EFSA's pre-submission advice to industry applicants while fully respecting the independence of scientific processes.
Slovenian: Možna vrednost svetovanja, ki bi ga agencija EFSA zagotavljala vlagateljem iz industrije pred vložitvijo vloge, ob hkratnem spoštovanju neodvisnosti znanstvenih postopkov.
English: All the new measures proposed as potentially strengthening the consistency of risk communication were considered by most respondents from both groups to be effective or very effective (between 61.4 % and 92.2 % of replies).
Slovenian: Vsi predlagani novi ukrepi, ki bi lahko okrepili doslednost obveščanja o tveganju, bi bili po mnenju večine sodelujočih državljanov in zainteresiranih strani učinkoviti ali zelo učinkoviti (61,4 % oz. 92,2 % odgovorov).
English: As regards the potential to re-enforce the audit system used for laboratories carrying out industry studies, the majority of both citizens (78.3 % of respondents) and stakeholders (72.6 % of respondents) considered that this would contribute to some or to a large extent to strengthening EFSA's risk assessments.
Slovenian: Kar zadeva možnost okrepitve sistema presoj, ki se uporablja za laboratorije, ki izvajajo študije industrije, je večina državljanov (78,3 % vprašanih) in zainteresiranih strani (72,6 % vprašanih) menila, da bi to do neke mere ali v veliki meri prispevalo k okrepitvi ocenjevanja tveganja agencije EFSA.
English: Citizens evaluated their level of knowledge of the EU assessment system for food safety and its regulatory framework as very good (22.64 %), good (33.65 %), sufficient (26.42 %), little (14.78 %) or none (2.52 %).
Slovenian: Državljani so ocenili svoje poznavanje sistema EU za ocenjevanje varnosti hrane in njegovega regulativnega okvira kot zelo dobro (22,64 %), dobro (33,65 %), zadovoljivo (26,42 %), slabo (14,78 %) ali neobstoječe (2,52 %).
English: 83.7 % of replies from citizens and by 63.4 % from stakeholders stated that complementing industry studies with verification studies would strengthen EFSA's risk assessment to some or to a large extent.
Slovenian: 83,7 % državljanov in 63,4 % zainteresiranih strani, ki so sodelovali v posvetovanju, je navedlo, da bi dopolnitev študij industrije s preveritvenimi študijami do neke mere ali v veliki meri okrepila oceno tveganja agencije EFSA.
English: Over 40 % of citizen replies disagreed or strongly disagreed with the statement suggesting that MS are sufficiently involved in EFSA's work.
Slovenian: Več kot 40 % sodelujočih državljanov je odgovorilo, da se ne strinja ali nikakor ne strinja z izjavo, da so države članice dovolj vključene v delo agencije EFSA.
English: Organisations evaluated their level of knowledge as very good (37.25 %), good (47.06 %), sufficient (14.38 %), little (0.65 %) or none (0.65 %).
Slovenian: Organizacije so ocenile svoje poznavanje kot zelo dobro (37,25 %), dobro (47,06 %), zadovoljivo (14,38 %), slabo (0,65 %) ali neobstoječe (0,65 %).
English: Elements including EFSA being able to choose excellent and independent experts from a large pool of candidates, as well as its independence from risk managers (Commission and MS) and from industry, were found by over 80 % of respondents in both the citizen and stakeholder groups to be useful or very useful.
Slovenian: Elementi, ki vključujejo možnost, da agencija EFSA lahko izbere odlične in neodvisne strokovnjake iz širokega nabora kandidatov, ter njeno neodvisnost od odgovornih za upravljanje tveganja (Komisije in držav članic) in od industrije, so po mnenju več kot 80 % sodelujočih državljanov in zainteresiranih strani koristni ali zelo koristni.
English: Citizens and stakeholders found that publishing industry studies, including raw/aggregated data but excluding business secrets or other confidential information, has a positive or very positive impact on:
Slovenian: Državljani in zainteresirane strani menijo, da ima objavljanje študij industrije, vključno z neobdelanimi/zbirnimi podatki, razen poslovnih skrivnosti ali drugih zaupnih informacij, pozitiven ali zelo pozitiven učinek na:
English: Over 75 % of respondents from both groups considered it useful or very useful to avoid duplication of risk assessments between EU and national levels, and to ensure an appropriate level of resources for EFSA.
Slovenian: Po mnenju več kot 75 % vprašanih iz obeh skupin sta izogibanje podvajanju ocenjevanja tveganja na ravni EU in nacionalnih ravneh ter zagotavljanje ustrezne ravni sredstev za agencijo EFSA koristni ali zelo koristni.
English: In particular, industry stakeholders considered valuable to some or to a large extent the possibility for providing pre-submission advice to individual applicants, while consumer organisations and some other NGOs considered that it would not contribute very much.
Slovenian: Zlasti zainteresirane strani iz industrije so menile, da je možnost svetovanja posameznim vlagateljem pred vložitvijo vloge do neke mere ali v veliki meri pomembna, po mnenju združenj potrošnikov in nekaterih drugih nevladnih organizacij pa prispevek svetovanja ne bi bil zelo pomemben.
English: Both citizen and stakeholder replies to the OPC showed that an open registry of studies, the use of machine readable formats and having different levels of access to studies would be useful or very useful tools.
Slovenian: Po mnenju državljanov in zainteresiranih strani, ki so sodelovali v odprtem javnem posvetovanju, bi bili odprt register študij, uporaba strojno berljivih formatov in uporaba različnih ravni dostopa do študij koristna ali zelo koristna orodja.
English: Among citizens, 58.8 % considered that immediate publication without confidentiality checks would have a positive or very positive impact, 6.9 % consider it would have no impact and 28.9 % considered that the impact would be negative or very negative.
Slovenian: 58,8 % sodelujočih državljanov je menilo, da bi imela takojšnja objava brez preverjanja zaupnosti pozitiven ali zelo pozitiven učinek, 6,9 % jih je menilo, da to ne bi imelo nikakršnega učinka, po mnenju 28,9 % sodelujočih državljanov pa bi bil učinek negativen ali zelo negativen.
English: In general, citizens found that all the additional measures regarding industry studies proposed in the OPC contribute to some or a large extent to strengthening EFSA's risk assessments; over 75 % of replies regarding the single measures acknowledged this.
Slovenian: Na splošno so državljani menili, da vsi dodatni ukrepi glede študij industrije, predlagani v odprtem javnem posvetovanju, do neke mere ali v veliki meri prispevajo k okrepitvi ocenjevanja tveganja agencije EFSA; to potrjuje več kot 75 % odgovorov glede posameznih ukrepov.
English: It was found that the tools currently available to support scientific cooperation between EFSA and MS to a significant extent already engage MS in the EU risk assessment system: over 70 % of respondents (both citizen and stakeholder groups) found that all the tools described contribute to some or a large extent.
Slovenian: Ugotovljeno je bilo, da orodja, ki so trenutno na voljo za podporo znanstvenega sodelovanja med agencijo EFSA in državami članicami, v veliki meri že vključujejo države članice v sistem EU za ocenjevanje tveganja: več kot 70 % vprašanih (tako iz skupine državljanov kot iz skupine zainteresiranih strani) je menilo, da vsa opisana orodja do neke mere ali v veliki meri prispevajo k temu.
English: Replies on the other scenarios related to the timing of publication do not showed strong polarisation of opinions, with the exception of the option to not publish industry studies at all: 77.1 % of citizens state that this would have a negative or very negative impact, with only 4.1 % considering that it would have a positive or very positive impact.
Slovenian: Odgovori glede ostalih scenarijev v zvezi s časovnim okvirom objavljanja niso pokazali velikih razlik v mnenju, z izjemo možnosti, da se študije industrije sploh ne bi objavljale: 77,1 % sodelujočih državljanov je navedlo, da bi to imelo negativen ali zelo negativen učinek, samo 4,1 % pa jih je menilo, da bi to imelo pozitiven ali zelo pozitiven učinek.
English: Both citizens and stakeholders considered that allocating more public resources to financing food safety studies is important for strengthening EFSA's risk assessment: around 80 % of citizen replies state that EU or national funding could contribute to some or to a large extent; the figure for stakeholders is slightly lower.
Slovenian: Državljani in zainteresirane strani so menili, da je dodelitev več javnih sredstev za financiranje študij o varnosti hrane pomembna za okrepitev ocenjevanja tveganja agencije EFSA: približno 80 % sodelujočih državljanov je odgovorilo, da bi lahko financiranje EU ali nacionalno financiranje do neke mere ali v veliki meri prispevalo k temu; v primeru zainteresiranih strani pa je ta delež nekoliko nižji.
English: allowing scrutiny by other scientific and third parties: 81.8 % of replies from citizens, 80.4 % from stakeholders,
Slovenian: omogočanje pregleda drugim znanstvenim in tretjim osebam: 81,8 % odgovorov državljanov, 80,4 % odgovorov zainteresiranih strani,
English: [1: https://ec.europa.eu/food/safety/general_food_law/fitness_check_en ][2: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_glyphosate_eci_final.pdf ]
Slovenian: ][2: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_glyphosate_eci_final.pdf. ]
English: For stakeholders, 71.9 % believe that the non-publication of industry studies would have a negative or very negative impact and only 1.3 % considered that it would have a positive impact.
Slovenian: Po mnenju 71,9 % sodelujočih zainteresiranih strani bi imelo neobjavljanje študij industrije negativen ali zelo negativen učinek, le 1,3 % pa jih je menilo, da bi imelo pozitiven učinek.
English: enhancing the exchange of information on risk among interested parties: 81.5 % of replies from citizens, 76.5 % from stakeholders.
Slovenian: izboljšanje izmenjave informacij o tveganju med zainteresiranimi stranmi: 81,5 % odgovorov državljanov, 76,5 % odgovorov zainteresiranih strani.
English: strengthening consumer trust in the EU risk assessment system: 84.9 % of replies from citizens, 73.9 % from stakeholders,
Slovenian: okrepitev zaupanja potrošnikov v sistem EU za ocenjevanje tveganja: 84,9 % odgovorov državljanov, 73,9 % odgovorov zainteresiranih strani,
English: Some MS saw the potentially for a small value of pre-submission advice in relation to its cost vs benefit analysis.
Slovenian: Po mnenju nekaterih držav članic bi lahko imelo svetovanje pred vložitvijo vloge glede na analizo stroškov in koristi le majhno vrednost.
English: Most respondents (over 75 % in both the citizen and stakeholder groups) agreed or strongly agreed that an increased involvement of MS is important to ensure that EFSA has a large pool of experts from MS. MS authorities highlighted the importance of incentives when promoting cooperation.
Slovenian: Večina vprašanih (več kot 75 % sodelujočih državljanov in zainteresiranih strani) se je strinjala ali zelo strinjala, da je večja vključenost držav članic pomembna, da se zagotovi, da ima EFSA na voljo širok nabor strokovnjakov iz držav članic.
English: However, 27.7 % of citizen replies and 26.1 % of stakeholder replies disagree or strongly disagree with this statement.
Slovenian: Vendar se s to izjavo ni strinjalo ali nikakor ni strinjalo 27,7 % sodelujočih državljanov in 26,1 % sodelujočih zainteresiranih strani.
English: The possibility of choosing excellent and independent experts from a large pool of candidates scored higher, with 96.2 % of citizen replies and 98.7 % of stakeholder replies considering it useful or very useful.
Slovenian: Možnost izbire odličnih in neodvisnih strokovnjakov iz širokega nabora kandidatov pa se zdi koristna ali zelo koristna večjemu številu vprašanih, in sicer 96,2 % državljanom in 98,7 % zainteresiranim stranem.
English: enhancing the transparency of the EU risk assessment system: 87.4 % of replies from citizens, 91.5 % from stakeholders,
Slovenian: izboljšanje preglednosti sistema EU za ocenjevanje tveganja: 87,4 % odgovorov državljanov, 91,5 % odgovorov zainteresiranih strani,
English: [5: https://ec.europa.eu/food/expert-groups/ag-ap/adv-grp_fchaph/wg_2018_en ][6: https://www.efsa.europa.eu/en/events/event/180206 ][7: https://ec.europa.eu/food/safety/general_food_law/expert_group_en ][8: https://www.efsa.europa.eu/sites/default/files/event/180214-m.pdf ]
Slovenian: ][8: https://www.efsa.europa.eu/sites/default/files/event/180214-m.pdf. ]
English: Citizens and stakeholders had the opportunity to provide feedback on a Commission roadmap from 20 December 2017 to 17 January 2018.
Slovenian: Državljani in zainteresirane strani so imeli priložnost predložiti povratne informacije glede časovnega načrta Komisije od 20. decembra 2017 do 17. januarja 2018. 20 zainteresiranih strani (15 trgovinskih in poslovnih združenj, štiri nevladne organizacije, en nacionalni organ) in en državljan so predložili povratne informacije.
English: The OPC showed such access as important or very important in 86.8 % of citizen replies and 88.2 % of stakeholder replies.
Slovenian: V odprtem javnem posvetovanju je 86,8 % sodelujočih državljanov in 88,2 % sodelujočih zainteresiranih strani odgovorilo, da je tak dostop pomemben ali zelo pomemben.
English: This proposal was meanwhile adopted and entered into force on 30 March.
Slovenian: Ta predlog je bil medtem sprejet in je začel veljati 30. marca.
English: Hence, it can only be of a temporary nature.
Slovenian: Zato je lahko le začasne narave.
English: A rigorous and conservative approach to financial management;
Slovenian: strog in konservativen pristop k finančnemu upravljanju;
English: It does not go beyond what is necessary to achieve the objectives sought by the instrument.
Slovenian: Ne presega tistega, kar je potrebno za doseganje ciljev instrumenta.
English: The Member State concerned should request support.
Slovenian: Zadevna država članica bi morala zaprositi za podporo.
English: This system will allow the Union to:
Slovenian: Ta sistem bo Uniji omogočil, da:
English: from candidate countries[11: Candidate countries and, where applicable, potential candidate countries from the Western Balkans.]
Slovenian: držav kandidatk[11: Države kandidatke in po potrebi potencialne države kandidatke z Zahodnega Balkana.]
English: From the beginning of the outbreak in the Union up until 30 March 2020, 334 396 cases and 22 209 deaths have been reported in the Member States.
Slovenian: Od začetka izbruha v Uniji do 30. marca 2020 je bilo v državah članicah sporočenih 334 396 primerov okužbe in 22 209 smrti.
English: It concerns an amount of up to EUR 100 billion.
Slovenian: Ta znaša največ 100 milijard EUR.
English: The Council has a broad margin of discretion for assessing whether the conditions of this legal basis are fulfilled.
Slovenian: Svet ima široko diskrecijsko pravico pri oceni, ali so pogoji te pravne podlage izpolnjeni.
English: Therefore, the United Kingdom should not participate in the financial assistance under this Regulation.
Slovenian: Zato Združeno kraljestvo ne bi smelo sodelovati pri finančni pomoči v skladu s to uredbo.
English: The probability of further transmission of COVID-19 in the Union is considered high.
Slovenian: Verjetnost nadaljnjega prenosa COVID-19 v Uniji se šteje za visoko.
English: Such a consultation also helps the Commission to properly evaluate the terms of the loan.
Slovenian: Tako posvetovanje bi Komisiji tudi pomagalo ustrezno oceniti pogoje posojila.
English: To that end, the Member State concerned shall provide the Commission with appropriate evidence.
Slovenian: V ta namen zadevna država članica Komisiji predloži ustrezne dokaze.
English: The Commission shall inform the Council when the Instrument becomes available.
Slovenian: Komisija obvesti Svet, ko je instrument na voljo.
English: DG BUDG is the policy area or budget title concerned.
Slovenian: GD BUDG je zadevno področje ali naslov v proračunu.
English: The Commission and the beneficiary Member State will conclude an implementation agreement.
Slovenian: Komisija in država članica upravičenka skleneta sporazum o izvajanju.
English: The global outbreak of that disease is evolving rapidly and it has been declared a pandemic by the WHO.
Slovenian: Svetovni izbruh te bolezni se hitro razvija, SZO pa ga je razglasila za pandemijo.
English: References to Member States in this Regulation shall not be understood as including the United Kingdom.
Slovenian: Sklicevanja na države članice v tej uredbi se ne razumejo, kot da vključujejo Združeno kraljestvo.
English: Possibilities to roll over debt.
Slovenian: možnosti obnovitve dolga.
English: The Economic and Financial Committee shall be kept informed of a refinancing or restructuring as referred to in paragraph 3.
Slovenian: Ekonomsko-finančni odbor je redno obveščen o refinanciranju ali prestrukturiranju iz odstavka 3.
English: Officials and temporary staff Issuance of securities in the capital markets (market analysis, prospectus, registration, investors relationship), management of proceeds, disbursements and reimbursements
Slovenian: Uradniki in začasni uslužbenci Izdaja vrednostnih papirjev na kapitalskih trgih (tržna analiza, prospekt, registracija, odnosi z vlagatelji), upravljanje prihodkov, izplačil in povračil
English: The Commission has also established a coordinating response team at political level, composed of the five Commissioners responsible for the most affected policies.
Slovenian: Komisija je ustanovila tudi skupino za usklajevanje odzivanja na politični ravni, ki jo sestavlja pet komisark in komisarjev, pristojnih za področja politike, ki jih ta kriza najbolj zadeva.
English: The maximum amount of financial assistance referred to in Article 3 shall not exceed EUR 100 000 000 000 for all Member States.
Slovenian: Najvišji znesek finančne pomoči iz člena 3 ne presega 100 000 000 000 EUR za vse države članice.
English: The rules of Article 220 of the Financial Regulation apply.
Slovenian: Uporabljajo se pravila iz člena 220 finančne uredbe.
English: Due to the urgency to prepare the proposal so that it can be adopted in a timely manner by the Council, a stakeholder consultation could not be carried out.
Slovenian: Zaradi nujne čimprejšnje priprave predloga, da bi ga Svet lahko pravočasno sprejel, posvetovanja z zainteresiranimi stranmi ni bilo mogoče izvesti.
English: from EFTA countries[10: EFTA: European Free Trade Association. ]
Slovenian: držav Efte[10: EFTA: Evropsko združenje za prosto trgovino. ]
English: Having regard to the Treaty on the Functioning of the European Union, and in particular Article 122 thereof,
Slovenian: ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 122 Pogodbe,
English: As announced in the Communication of 13 March 2020, the Union also stands ready to support Member States where possible in alleviating the employment impact for individuals and the hardest hit sectors.
Slovenian: Kot je bilo napovedano v sporočilu z dne 13. marca 2020, je Unija, kjer je to mogoče, pripravljena podpreti države članice tudi pri ublažitvi učinka na zaposlenost za posameznike ter za najbolj prizadete sektorje.
English: [6: ABM: activity-based management; ABB: activity-based budgeting.]
Slovenian: [6: ABM: upravljanje po dejavnostih, ABB: oblikovanje proračuna po dejavnostih.]