qanastek/ELRC-Medical-V2 huggingface dataset:
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.
Translation (en-sl): 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
Translation (en-sl): Člen 32d
English: executive agencies
Translation (en-sl): prek izvajalskih agencij.
English: TOTAL COST 19.512 34.145 48.779 48.779 48.779 199.994
Translation (en-sl): 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:
Translation (en-sl): (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.
Translation (en-sl): ][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
Translation (en-sl): 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:
Translation (en-sl): (4) v členu 11(2) se uvodni stavek nadomesti z naslednjim:
English: Regulation (EC) No 1831/2003 is amended as follows:
Translation (en-sl): Uredba (ES) št. 1831/2003 se spremeni:
English: (a) in paragraph 3 the introductory sentence is replaced by the following:
Translation (en-sl): (a) v odstavku 3 se uvodni stavek nadomesti z naslednjim:
English: Article 39c
Translation (en-sl): Člen 39c
English: Article 7
Translation (en-sl): Člen 7
English: (2) in Article 6, paragraph 7 is replaced by the following:
Translation (en-sl): (2) v členu 6 se odstavek 7 nadomesti z naslednjim:
English: (d) the second subparagraph of paragraph 5 is replaced by the following:
Translation (en-sl): (d) drugi pododstavek odstavka 5 se nadomesti z naslednjim:
English: Article 39b
Translation (en-sl): Člen 39b
English: For consistency, the Commission proposal would also amend other sectoral food legislation.
Translation (en-sl): Zaradi skladnosti bi predlog Komisije spremenil tudi drugo sektorsko živilsko zakonodajo.
English: Targeted consultations with specific stakeholder groups also took place.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): Zmogljivost za več javnih sredstev za financiranje študij o varnosti hrane.
English: Some MS expressed reservations on the potential added value of this measure.
Translation (en-sl): 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.
Translation (en-sl): Znanstvena neodvisnost in odličnost strokovnjakov sta temelja sistema EU za ocenjevanje tveganja.
English: Sustainability of the risk assessment system and involvement of MS
Translation (en-sl): Trajnost sistema ocenjevanja tveganja in vključenost držav članic
English: Need to ensure the protection of confidential data and personal data.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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:
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): Zainteresirane strani iz industrije so prav tako poudarile potrebo po preprečevanju nepoštene uporabe poslovnih podatkov.
English: Evidence from industry studies
Translation (en-sl): Dokazi iz študij industrije
English: Conclusions
Translation (en-sl): 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".
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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').
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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 ]
Translation (en-sl): [4: https://ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-chain_sl. ]
English: Risk Communication
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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 %).
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.
Translation (en-sl): 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.