FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: It has also strengthened the cooperation with national and international scientific bodies as well as the exchange of information between Member States, the Commission and EFSA itself.
Slovenian: Prav tako je okrepila sodelovanje z nacionalnimi in mednarodnimi znanstvenimi organi ter izmenjavo informacij med državami članicami, Komisijo in agencijo EFSA.
English: This paved the way for a complete overhaul of the regulatory framework, with the focus on the GFL Regulation in 2002.
Slovenian: To je utrlo pot popolni prenovi regulativnega okvira s poudarkom na uredbi o splošni živilski zakonodaji v letu 2002.
English: There are no negative impacts in the duration of authorisation procedures since this is a parallel activity.
Slovenian: Ni negativnih učinkov na trajanje odobritvenih postopkov, ker gre za vzporedno dejavnost.
English: [4: C(2017) 8414 final.]
Slovenian: [4: COM(2017) 8414 final.]
English: They also seriously undermined public confidence in the Union food safety regulatory framework.
Slovenian: Prav tako so te krize resno omajale zaupanje javnosti v regulativni okvir Unije za varnost hrane.
English: The notification obligation under paragraph 1, also applies to Union laboratories carrying out those studies.
Slovenian: Obveznost uradnega obveščanja iz odstavka 1 velja tudi za laboratorije Unije, ki izvajajo navedene študije.
English: In addition to monitoring compliance, DG SANTE identifies and disseminates good practices in collaboration with the agencies.
Slovenian: GD SANTE poleg spremljanja skladnosti tudi opredeljuje in razširja dobre prakse v sodelovanju z agencijami.
English: (a) the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) and Annex I to this Regulation; and,
Slovenian: (a) načrtov študij, ki dokazujejo učinkovitost krmnega dodatka glede na cilje njegove nameravane uporabe, kakor je opredeljena v členu 6(1) in Prilogi I k tej uredbi; ter
English: Expected generated Union added value (ex-post)
Slovenian: Pričakovana ustvarjena dodana vrednost Unije (naknadno)
English: Their interplay can impact on the acceptability of the risk assessment by the general public.
Slovenian: Njihovo medsebojno učinkovanje lahko vpliva na sprejemljivost ocene tveganja za splošno javnost.
English: The Commission shall make the application available to the Member States without delay.
Slovenian: Komisija brez odlašanja da vlogo na voljo državam članicam.
English: (c) any other information deemed confidential within the specific procedural rules referred to in Article 5(1)(n) of this Regulation.
Slovenian: (c) vseh drugih informacij, ki veljajo za zaupne v posebnih postopkovnih pravilih iz člena 5(1)(n) te uredbe.
English: (a) ensure that accurate, appropriate and timely information is interactively exchanged, based on the principles of transparency, openness, and responsiveness;
Slovenian: (a) zagotavljati interaktivno izmenjavo točnih, ustreznih in pravočasnih informacij na podlagi načel preglednosti, odprtosti in odzivnosti;
English: (a) to any intellectual property right which may exist over documents or their content; and,
Slovenian: (a) katero koli pravico intelektualne lastnine, ki lahko obstaja na dokumentih ali njihovi vsebini; ter
English: Its primary mission is to provide scientific advice at the request of the Commission, Member States and the European Parliament and on its own motion.
Slovenian: Njena glavna naloga je zagotavljati znanstveno svetovanje na zahtevo Komisije, držav članic in Evropskega parlamenta ter tudi na lastno pobudo.
English: Where the Commission considers that the continuation of the Authority is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose that the relevant provisions of this Regulation be amended accordingly or repealed.
Slovenian: Če Komisija meni, da nadaljnji obstoj agencije glede na zastavljene cilje, pooblastila in naloge ni več upravičen, lahko predlaga ustrezno spremembo ali razveljavitev zadevnih določb te uredbe.
English: Setting up the EFSA has given Union measures a sounder scientific basis.
Slovenian: Z ustanovitvijo agencije EFSA so ukrepi Unije dobili trdnejšo znanstveno podlago.
English: [41: OJ L 123, 12.5.2016, p.
Slovenian: [41: UL L 123, 12.5.2016, str.
English: [42: As referred to in Article 54(2)(a) or (b) of the Financial Regulation.]
Slovenian: [42: Po členu 54(2)(a) oz. (b) finančne uredbe.]
English: Each Member State shall nominate a member and an alternate member to the Management Board.
Slovenian: Vsaka država članica predlaga člana in nadomestnega člana upravnega odbora.
English: Protection of personal data
Slovenian: Varstvo osebnih podatkov
English: The EFSA also regularly fine-tunes and strengthens its strict policies on independence, transparency and openness.
Slovenian: EFSA prav tako redno prilagaja in krepi svoje stroge politike neodvisnosti, preglednosti in odprtosti.
English: The Commission shall adopt the general plan for risk communication within [two years from the date of application of this Regulation] and shall keep it updated, taking into account technical and scientific progress and experience gained.
Slovenian: Komisija sprejme splošni načrt obveščanja o tveganju v [dveh letih od začetka uporabe te uredbe] in ga redno posodablja, pri čemer se upoštevajo tehnični in znanstveni napredek ter pridobljene izkušnje.
English: (20) There are certain public concerns about the Authority's assessment in the area of authorisation being primarily based on industry studies.
Slovenian: (20) Obstajajo nekateri pomisleki javnosti, da ocena Agencije v zvezi z odobritvijo temelji predvsem na študijah industrije.
English: Member States that provide the EFSA with expertise also need to receive more compensation.
Slovenian: Države članice, ki agenciji EFSA zagotavljajo strokovno znanje, morajo prav tako prejeti višja nadomestila.
English: The involvement of the EFSA Executive Director in the selection process is an additional guarantee that the independence criteria will be met.
Slovenian: Vključenost izvršnega direktorja agencije EFSA v izbirni postopek je dodatno jamstvo, da bodo izpolnjena merila glede neodvisnosti.
English: Transparency and confidentiality rules currently vary depending on the sub-area of regulation concerned.
Slovenian: Pravila o preglednosti in zaupnosti se trenutno razlikujejo glede na zadevno podpodročje urejanja.
English: With regard to the reliability and robustness of studies submitted by industry in the context of authorisation procedures, the following impacts were in particular considered:
Slovenian: Kar zadeva zanesljivost in trdnost študij, ki jih predloži industrija v okviru odobritvenih postopkov, so bili zlasti upoštevani naslednji učinki:
English: Provisions in relation to the nomination, selection and appointment of experts include strict criteria on independence, thus providing appropriate safeguards.
Slovenian: Določbe v zvezi s predlaganjem, izbiro in imenovanjem strokovnjakov vključujejo stroga merila glede neodvisnosti, kar zagotavlja ustrezne zaščitne ukrepe.
English: Estimate to be expressed in full amounts (or at most to one decimal place)
Slovenian: ocena, izražena v celih številkah (ali na največ eno decimalno mesto natančno)
English: As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.
Slovenian: Kakor hitro je mogoče in v treh mesecih od uradnega obvestila, lahko Evropski parlament predloži svoje mnenje v presojo Svetu, ki potem imenuje navedene člane.
English: Impact on the European Food Safety Authority (EFSA)
Slovenian: Posledice za Evropsko agencijo za varnost hrane (EFSA)
English: Although in principle a revision of Regulation (EC) No 178/2002 could be used as an opportunity to set up a more comprehensive monitoring system of the implementation of Union food law, the targeted scope of this proposal is too limited to accommodate the establishment of such a system.
Slovenian: Čeprav bi načeloma lahko revizijo Uredbe (ES) št. 178/2002 izkoristili kot priložnost za vzpostavitev celovitejšega sistema za spremljanje izvajanja živilske zakonodaje Unije, je ciljno področje uporabe tega predloga preveč omejeno, da bi omogočalo vzpostavitev takega sistema.
English: The proposal also provides for a better organisation of the Panels' work.
Slovenian: Predlog prav tako zagotavlja boljšo organizacijo dela znanstvenih svetov.
English: [43: Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx.]
Slovenian: [43: Pojasnila o načinih upravljanja in sklici na finančno uredbo so na voljo na spletišču BudgWeb: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx.]
English: (d) facilitate understanding and dialogue amongst all interested parties; and,
Slovenian: (d) olajšati razumevanje in dialog med vsemi zainteresiranimi stranmi ter
English: Problems in relation to safety have a huge impact on consumers' confidence and consequently on market stability, trade flows and the climate for innovation.
Slovenian: Težave v zvezi z varnostjo močno vplivajo na zaupanje potrošnikov in posledično na stabilnost trga, trgovinske tokove in okolje za inovacije.
English: A delegated act adopted pursuant to Article 8(c) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
Slovenian: Delegirani akt, sprejet na podlagi člena 8(c), začne veljati le, če mu niti Evropski parlament niti Svet ne nasprotuje v roku dveh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu o tem aktu ali če pred iztekom tega roka tako Evropski parlament kot Svet obvestita Komisijo, da mu ne bosta nasprotovala.
English: The impact on the timing of authorisation is minimal as detailed for each measure.
Slovenian: Učinek na časovni potek odobritve je minimalen, kot je podrobno opisano za vsak ukrep.
English: It shall in particular make public without delay:
Slovenian: Brez odlašanja objavi zlasti:
English: (25) It is therefore necessary to strengthen the transparency of the risk assessment process in a proactive manner.
Slovenian: (25) Zato je treba proaktivno okrepiti preglednost postopka ocenjevanja tveganja.
English: Type[47: Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).]
Slovenian: vrsta[47: Realizacije so dobavljeni proizvodi in opravljene storitve (npr. število financiranih izmenjav študentov, število kilometrov novozgrajenih cest itd.).]
English: The delegation of power referred to in Article 8(c) may be revoked at any time by the European Parliament or by the Council.
Slovenian: Prenos pooblastila iz člena 8(c) lahko kadar koli prekliče Evropski parlament ali Svet.
English: Indeed, the notification of planned studies represents a relatively small burden for the applicant.
Slovenian: Dejansko predstavlja obveščanje o načrtovanih študijah razmeroma majhno breme za vlagatelja.
English: The Commission does not see scope to simplify or reduce these steps as this could have a negative impact not only on the perception of the transparency of the system but also on ensuring that the evidence presented for EFSA's assessments is complete.
Slovenian: Komisija ne vidi možnosti za poenostavitev ali zmanjšanje teh ukrepov, saj bi to lahko imelo negativne posledice ne le na dojemanje preglednosti sistema, temveč tudi na zagotavljanje popolnosti dokazov, predloženih v oceno agenciji EFSA.
English: The register shall be managed by the Authority.
Slovenian: Register upravlja agencija.
English: It provides, amongst others, that food law must be based on risk analysis, except where this is not appropriate to the circumstances or the nature of the measure.
Slovenian: Med drugim določa, da mora živilska zakonodaja temeljiti na analizi tveganja, razen če to glede na okoliščine ali vrsto ukrepa ni primerno.
English: Budget revenue line: Appropriations available for the current financial year Impact of the proposal/initiative[53: As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 25 % for collection costs.]
Slovenian: Prihodkovna proračunska vrstica Odobritve na voljo za tekoče proračunsko leto Posledice predloga/pobude[53: Pri tradicionalnih lastnih sredstvih (carine, prelevmani na sladkor) se navedejo neto zneski, tj. bruto zneski po odbitku 25 % stroškov pobiranja.]
English: These put public health at great risk and the resulting market support measures and trade disruption cost a huge amount.
Slovenian: Zaradi tega je bilo močno ogroženo javno zdravje, posledični ukrepi za podporo trgu in motnje v trgovanju pa so povzročili ogromne stroške.
English: It addresses industry demands (in particular SMEs) for further support in the preparation of the authorisation application.
Slovenian: Postopek je odgovor na zahteve industrije (zlasti MSP) po nadaljnji podpori pri pripravi vlog za odobritev.
English: Access shall be based at the minimum on a system requiring two factor authentication or providing an equivalent level of security.
Slovenian: Dostop mora temeljiti najmanj na sistemu, ki zahteva dvostopenjsko avtentikacijo, ali sistemu, ki zagotavlja enakovredno raven varnosti.
English: Difficulties in attracting new experts due to insufficient recognition of scientists' career, inadequate financial compensation in particular for their employers and excessive demand on their time.
Slovenian: težave pri privabljanju novih strokovnjakov zaradi nezadostnega priznavanja poklicne poti znanstvenikov, neustreznih finančnih nadomestil, zlasti za njihove delodajalce, ter prevelikega časovnega vložka;
English: European stakeholder organisations representing farmers, cooperatives, the food industry, retailers, consumers, professionals and civil society were consulted at an ad hoc meeting of the Advisory Group on the Food Chain, Animal and Plant Health on 5 February 2018.
Slovenian: Posvetovanja z evropskimi organizacijami zainteresiranih strani, ki zastopajo kmete, zadruge, živilsko industrijo, trgovce na drobno, potrošnike, strokovnjake in civilno družbo, so potekala na ad hoc sestanku svetovalne skupine za prehranjevalno verigo ter zdravje živali in rastlin 5. februarja 2018.
English: As this is a revision of an existing piece of legislation falling under the Commission's Regulatory Fitness and Performance Programme REFIT, the Commission has looked at opportunities to simplify and reduce burdens.
Slovenian: Glede na to, da gre za revizijo obstoječega zakonodajnega akta, ki spada v okvir programa Komisije za ustreznost in uspešnost predpisov (REFIT), je Komisija preučila možnosti za poenostavitev in zmanjšanje bremena.
English: Activity: [General Food Law]
Slovenian: Dejavnost: [splošna živilska zakonodaja]
English: (38) In order to enable the Authority and the business operators to adapt to the new requirements while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation.
Slovenian: (38) Da bi Agenciji in nosilcem dejavnosti omogočili, da se prilagodijo novim zahtevam, in hkrati zagotovili, da Agencija še naprej nemoteno deluje, je treba določiti prehodne ukrepe za uporabo te uredbe.
English: This should also lead to more adequate and complete evidence being submitted and thus improve the efficiency of the risk assessment process in EFSA.
Slovenian: To bi moralo prispevati tudi k predložitvi ustreznejših in popolnejših dokazov, s čimer bi se izboljšala učinkovitost postopka ocenjevanja tveganja v agenciji EFSA.
English: Policy area: [Food Safety]
Slovenian: Področje: [varnost hrane]
English: from EFTA countries[45: EFTA: European Free Trade Association. ]
Slovenian: držav Efte[45: Efta: Evropsko združenje za prosto trgovino. ]
English: (11) Experience shows that the role of the Management Board of the Authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the Authority.
Slovenian: (11) Izkušnje kažejo, da je vloga upravnega odbora Agencije usmerjena v upravne in finančne vidike in ne vpliva na neodvisnost njenega znanstvenega dela.
English: Where necessary, networking groups and adequate IT tools dedicated to analysing fraud cases related to the financing implementing activities of this Regulation will be set up.
Slovenian: Po potrebi bodo vzpostavljene skupine za mrežno povezovanje in ustrezna informacijska orodja, namenjena analizi primerov goljufij, povezanih z dejavnostmi izvajanja financiranja iz te uredbe.
English: Each Panel shall include a maximum of 21 members.
Slovenian: Vsak znanstveni svet vključuje največ 21 članov.
English: (c) take into account risk perceptions;
Slovenian: (c) upoštevati dojemanje tveganja;
English: Public access to the dossiers
Slovenian: Javni dostop do dokumentacije
English: This in turn ensures that there is a common understanding of and approach to food safety that promotes both the effective implementation and enforcement of legislation and facilitates the operation of the internal market in a key sector of the European economy.
Slovenian: To pa zagotavlja, da obstajata skupno razumevanje in pristop k varnosti hrane, ki spodbuja učinkovito izvajanje in izvrševanje zakonodaje ter olajšuje delovanje notranjega trga v ključnem sektorju evropskega gospodarstva.
English: Member States shall ensure that the members of the Scientific Panels do not receive any instruction at any national level and that their independent scientific contribution to the risk assessment system at Union level is recognised as a priority task for the protection of the safety of the food chain.
Slovenian: Države članice zagotovijo, da člani znanstvenih svetov ne prejemajo nobenih navodil na nobeni nacionalni ravni ter da je njihov neodvisni znanstveni prispevek k sistemu ocenjevanja tveganja na ravni Unije prepoznan kot prednostna naloga pri zaščiti varnosti prehranske verige.
English: (32) Having regard to the fact that the Authority would be required to store scientific data, including confidential and personal data, it is necessary to ensure that such storage is carried out in accordance with a high level of security.
Slovenian: (32) Ob upoštevanju dejstva, da bi Agencija morala shranjevati znanstvene podatke, vključno z zaupnimi in osebnimi podatki, je treba zagotoviti, da je takšno shranjevanje v skladu z visoko stopnjo varnosti.
English: In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Slovenian: Za zagotovitev enakopravnega sodelovanja pri pripravi delegiranih aktov Evropski parlament in Svet zlasti prejmeta vse dokumente sočasno s strokovnjaki iz držav članic, njuni strokovnjaki pa se lahko sistematično udeležujejo sestankov strokovnih skupin Komisije, ki zadevajo pripravo delegiranih aktov.
English: Furthermore, the EFSA staff will provide the advice without the involvement of the Scientific Panels.
Slovenian: Poleg tega bo osebje agencije EFSA svetovalo brez udeležbe znanstvenih svetov.
English: It establishes certain general principles to underpin all future Union and national food law, the most important of which is the risk analysis principle.
Slovenian: Določa nekatera splošna načela, na katerih temelji vsa prihodnja živilska zakonodaja Unije in nacionalna živilska zakonodaja, med katerimi je najpomembnejše načelo analize tveganja.
English: That process should be combined with an open dialogue between all interested parties to ensure the coherence and consistency within the risk analysis process.
Slovenian: Navedeni postopek bi bilo treba združiti z odprtim dialogom med vsemi zainteresiranimi stranmi, da se zagotovita skladnost in doslednost v postopku analize tveganja.
English: It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1) of this Regulation.
Slovenian: Objavi tudi vsako zaprosilo za mnenje in vsako podaljšanje roka v skladu s členom 6(1) te uredbe.
English: This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Slovenian: Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
English: Problems that the initiative aims to tackle
Slovenian: Vprašanja, ki naj bi jih pobuda obravnavala
English: However, the term of office of the members referred to in paragraph 1a(a) and (b) shall not be limited in duration.
Slovenian: Vendar se mandat članov iz odstavkov 1a(a) in (b) časovno ne omeji.
English: (12) The Management Board should be selected in such a way as to secure the highest standards of competence and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and the Commission.
Slovenian: (12) Upravni odbor bi bilo treba izbrati tako, da se zagotovijo najvišji standardi strokovne usposobljenosti in širok obseg ustreznih izkušenj predstavnikov držav članic, Evropskega parlamenta in Komisije.
English: The contributions received from citizens and stakeholders confirmed the importance of the aspects of the Union food safety risk assessment model this proposal addresses and the need to ensure that the proposal strengthens all those aspects, while safeguarding the principles on which the Union food safety system is based.
Slovenian: Prejeti prispevki državljanov in zainteresiranih strani so potrdili pomembnost vidikov modela za oceno tveganja v zvezi z varnostjo hrane v Uniji, ki jih obravnava ta predlog, ter potrebo zagotoviti, da predlog krepi vse te vidike, obenem pa ohranja načela, na katerih temelji sistem Unije za varnost hrane.
English: Ex-post evaluations/fitness checks of existing legislation
Slovenian: Naknadne ocene/preverjanja ustreznosti obstoječe zakonodaje
English: (ii) Independence and absence of conflict of interests in accordance with Article 37(2) and the Authority's independence policy and implementing rules on the independence of the Scientific Panels' members;
Slovenian: (ii) neodvisnost in odsotnost nasprotja interesov v skladu s členom 37(2) in politiko neodvisnosti agencije ter izvedbenimi pravili o neodvisnosti članov znanstvenih svetov;
English: If the applicant disagrees with the assessment of the Authority it may state its views or withdraw its application within two weeks from the date on which it was notified of the Authority's position.
Slovenian: Če se vlagatelj ne strinja z oceno agencije, lahko izrazi svoje mnenje ali umakne svojo vlogo v dveh tednih od datuma, ko je bil obveščen o stališču agencije.
English: The following factors have an impact on this:
Slovenian: Na to vplivajo naslednji dejavniki:
English: In order to ensure uniform conditions for the implementation of Regulation (EC) No 178/2002 with regard to the adoption of standard data formats and software packages, implementing powers should be conferred on the Commission.
Slovenian: Za zagotovitev enotnih pogojev za izvajanje Uredbe (ES) št. 178/2002 v zvezi s sprejetjem standardnih formatov podatkov in paketov programske opreme, bi bilo treba na Komisijo prenesti izvedbena pooblastila.
English: The proposal is based on Articles 43, 114, and 168(4)(b) of the Treaty on the Functioning of the European Union.
Slovenian: Predlog temelji na členih 43, 114 in členu 168(4)(b) Pogodbe o delovanju Evropske unije (PDEU).
English: In particular, the existing strict criteria on independence are maintained and specific provisions require Member States to set up specific measures ensuring that the experts have concrete means to act independently as required by the proposal.
Slovenian: Ohranjajo se zlasti obstoječa stroga merila glede neodvisnosti, države članice pa morajo v skladu s posebnimi določbami vzpostaviti posebne ukrepe za zagotovitev, da imajo strokovnjaki na voljo konkretna sredstva za neodvisno delovanje, kot se zahteva v predlogu.
English: "The number of members in each Scientific Panel within the maximum provided for in paragraph 5g.
Slovenian: „število članov v posameznem znanstvenem svetu, ob upoštevanju največjega števila, navedenega v odstavku 5g.
English: External staff (in Full Time Equivalent unit: FTE)[49: AC = Contract Staff; AL = Local Staff; END = Seconded National Expert; INT = agency staff; JED = Junior Experts in Delegations. ]
Slovenian: Zunanji sodelavci (v ekvivalentu polnega delovnega časa: EPDČ)[49: PU = pogodbeni uslužbenec; LU = lokalni uslužbenec; NNS = napoteni nacionalni strokovnjak; ZU = začasni uslužbenec; MSD = mladi strokovnjak na delegaciji. ]
English: of the multiannual financial framework (Total commitments = Total payments)
Slovenian: večletnega finančnega okvira SKUPAJ (obveznosti skupaj = plačila skupaj)
English: The Commission therefore committed to come forward with a legislative proposal by May 2018 covering these and other aspects such as the governance of EFSA drawing up on the results of the Fitness Check of the GFL Regulation and after a public consultation.
Slovenian: Komisija se je zato zavezala, da bo do maja 2018 pripravila zakonodajni predlog, ki bo zajemal te in druge vidike, kot je upravljanje agencije EFSA, na podlagi preverjanja ustreznosti uredbe o splošni živilski zakonodaji in po javnem posvetovanju.
English: The estimated impact on expenditure and staffing for the years 2021 and beyond in this legislative financial statement is added for illustrative purpose and does not pre-judge the next multiannual financial framework.
Slovenian: Ocena posledic za odhodke in zaposlovanje za leto 2021 in naslednja leta iz te ocene finančnih posledic zakonodajnega predloga je priložena v informativni namen in ne posega v prihodnji večletni finančni okvir.
English: This is also partly due to the different transparency and confidentiality rules that are laid down not only in Regulation (EC) No 178/2002 but also in other Union legislative acts covering the agri-food chain.
Slovenian: To je deloma tudi posledica tega, da so različna pravila o preglednosti in zaupnosti določena v Uredbi (ES) št. 178/2002 in tudi v drugih zakonodajnih aktih Unije, ki zajemajo agroživilsko verigo.
English: The disclosure of the information mentioned in paragraph (1)(c) to the public shall be without prejudice:
Slovenian: Razkritje informacij iz odstavka (1)(c) javnosti ne posega v:
English: (e) promote appropriate involvement of all interested parties; and,
Slovenian: (e) spodbujanje ustrezne udeležbe vseh zainteresiranih strani ter
English: The power to adopt delegated acts is conferred upon the Commission subject to the conditions laid down in this Article.
Slovenian: Pooblastilo za sprejemanje delegiranih aktov je preneseno na Komisijo pod pogoji, določenimi v tem členu.
English: These draft standard data formats and software packages shall not be based on proprietary standards and shall ensure interoperability with existing data submission approaches to the extent possible.
Slovenian: Te predlagane standardne oblike zapisa podatkov in predlagani paketi programske opreme ne temeljijo na lastniških standardih ter v največji možni meri zagotavljajo interoperabilnost s sedanjimi pristopi za predložitev podatkov.
English: (b) proceed, without delay, to a concrete and individual examination of the confidentiality request in accordance with this Article;
Slovenian: (b) nemudoma konkretno in posamično pregleda zahteve za zaupnost v skladu s tem členom;
English: GRAND TOTAL 34 60 85 85 85
Slovenian: VSE SKUPAJ 34 60 85 85 85
English: Citizens demand that the risk assessment process in the area of food law (and the decision-making based on it) be more transparent.
Slovenian: Državljani zahtevajo večjo preglednost postopka ocene tveganja na področju živilske zakonodaje (in odločanja na podlagi tega postopka).
English: The human resources required will be met by staff from the DG who are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
Slovenian: Potrebe po človeških virih se krijejo z osebjem GD, ki je že dodeljeno za upravljanje ukrepa in/ali je bilo prerazporejeno znotraj GD, po potrebi skupaj z dodatnimi viri, ki se lahko pristojnemu GD dodelijo v okviru postopka letne dodelitve virov glede na proračunske omejitve.
English: The current term of office of the Scientific Committee and Panel members shall be prolonged until that date.
Slovenian: Sedanji mandat članov znanstvenega odbora in znanstvenih svetov se podaljša do navedenega datuma.
English: This provision does not apply to the submission of any supplementary information by the applicants during the risk assessment process.
Slovenian: Ta določba se ne uporablja za predložitev nobenih dodatnih informacij, ki jih vlagatelji predložijo v postopku ocenjevanja tveganja.
English: In addition to the application of all regulatory control mechanisms, the responsible services will devise an anti-fraud strategy in line with the Commission's anti-fraud strategy (CAFS) adopted on 24 June 2011 in order to ensure inter alia that its internal anti-fraud related controls are fully aligned with the CAFS and that its fraud risk management approach is geared to identify fraud risk areas and adequate responses.
Slovenian: Pristojne službe bodo poleg uporabe vseh regulativnih kontrolnih mehanizmov pripravile strategijo za boj proti goljufijam, ki bo skladna s strategijo Komisije na področju boja proti goljufijam, sprejeto 24. junija 2011, da bi med drugim zagotovile, da so njene notranje kontrole, povezane z bojem proti goljufijam, v celoti skladne z navedeno strategijo ter da je njen pristop k obvladovanju tveganja goljufij usmerjen v opredelitev področij, na katerih obstaja tveganje goljufij, in ustreznih odzivov nanje.
English: Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Commission shall assess the Authority's performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines.
Slovenian: Najpozneje pet let po datumu iz člena [začetek veljavnosti uredbe o spremembi uredbe o splošnih načelih živilske zakonodaje], nato pa vsakih pet let Komisija v skladu s svojimi smernicami oceni uspešnost agencije v zvezi z njenimi cilji, pooblastili, nalogami, postopki in lokacijo.
English: In addition to members and alternate members referred to in paragraph 1, the Management Board shall include:
Slovenian: Poleg članov in nadomestnih članov iz odstavka 1 upravni odbor sestavljajo:
English: Any actions in these areas need to take place at Union level and primarily within the existing Union legislative framework established by the GFL Regulation and in seven other relevant sectoral legislative acts.
Slovenian: Ukrepe na teh področjih je treba izvajati na ravni Unije in predvsem v obstoječem zakonodajnem okviru Unije, vzpostavljenem z uredbo o splošni živilski zakonodaji in sedmimi drugimi zadevnimi sektorskimi zakonodajnimi akti.
English: In addition, the current rules on confidentiality vary according to the sub-area concerned, thus not ensuring a consistent way to manage transparency.
Slovenian: Poleg tega se sedanja pravila o zaupnosti razlikujejo glede na zadevno podpodročje, zato ne zagotavljajo dosledne uporabe načela preglednosti.
English: (a) Where urgent action is essential to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; and,
Slovenian: (a) agencija lahko v primeru, kadar je nujno takojšnje ukrepanje za zaščito zdravja ljudi, živali ali okolja, npr. v izrednih razmerah, razkrije informacije iz odstavkov 2 in 3; ter
English: The national food safety authorities of the Member States (meeting of the EFSA Advisory Forum on 6 February 2018) and the Scientific Committee of EFSA (15 February 2018) were also consulted.
Slovenian: Potekala so tudi posvetovanja z nacionalnimi organi držav članic za varnost hrane (sestanek posvetovalnega foruma agencije EFSA z dne 6. februarja 2018) in znanstvenim odborom agencije EFSA (15. februarja 2018).
English: Detailed explanation of the specific provisions of the proposal
Slovenian: Natančnejša pojasnitev posameznih določb predloga
English: Moreover, a strict application of the rules on conflict of interests provided in the proposal will be ensured.
Slovenian: Poleg tega se bo zagotovila dosledna uporaba pravil o nasprotju interesov, ki jih določa predlog.
English: Collection and use of expertise
Slovenian: Zbiranje in uporaba strokovnih mnenj
English: This has resulted in a mutual understanding of risks, minimised duplications of work and limited the number of scientific divergences between the EFSA and other risk assessment bodies.
Slovenian: Tako se je spodbudilo vzajemno razumevanje tveganja, kar najbolj zmanjšalo podvajanje dela in omejilo število znanstvenih razhajanj med agencijo EFSA in drugimi organi za oceno tveganja.
English: [2: Food law authorisations cover different subject matters: substances, products, health claims and processes but for the ease of reading, the reference to substances in the text covers all.]
Slovenian: [2: Predmet odobritve na podlagi živilske zakonodaje je lahko: snov, izdelek, zdravstvena trditev in postopek, zaradi lažjega branja pa izraz „snov" v tem besedilu zajema vse to.]
English: Member States shall assess the confidentiality requests.
Slovenian: Države članice ocenijo zahteve za zaupnost.
English: (b) Article 1(3) shall apply as from the date of appointment of the members of the Scientific Panels, which shall be announced in a notice in the ‘C' series of the Official Journal of the European Union.
Slovenian: (b) člen 1(3) se uporablja od dneva imenovanja članov znanstvenih svetov, ki se objavi z obvestilom v seriji C Uradnega lista Evropske unije.
English: In addition, the confidentiality regime established by the proposal provides that any information revealing the business strategy of the applicant is confidential.
Slovenian: Poleg tega ureditev glede zaupnosti, vzpostavljena s tem predlogom, določa, da so kakršne koli informacije, ki razkrivajo poslovno strategijo vlagatelja, zaupne.
English: 2) It will help to improve citizens' confidence in the credibility of scientific studies and consequently confidence in the Union risk assessment system.
Slovenian: 2) Predlog bo pomagal izboljšati zaupanje državljanov v verodostojnost znanstvenih študij in posledično v sistem Unije za ocenjevanje tveganja.
English: Other simplification aspects include the harmonisation of the confidentiality rules across different sectors providing a similar baseline to all industry applicants in terms of predictability.
Slovenian: Drugi vidiki poenostavitve vključujejo uskladitev pravil o zaupnosti v različnih sektorjih, kar vsem vlagateljem iz industrije omogoča podobno izhodišče v smislu predvidljivosti.
English: Many stakeholders and citizens complain that the EFSA's evaluations of authorisation applications are essentially based on studies, data and information generated (and paid for) by the applicant for authorisation.
Slovenian: Številne zainteresirane strani in državljani se pritožujejo, da ocene vlog za odobritev, ki jih opravi agencija EFSA, v bistvu temeljijo na študijah, podatkih in informacijah, ki jih je pripravil (in plačal) vlagatelj vloge za odobritev.
English: The proposal respects the needs of EFSA for independence, excellence and multi-disciplinary expertise.
Slovenian: Predlog upošteva potrebe agencije EFSA po neodvisnosti, odličnosti in večdisciplinarnem strokovnem znanju.
English: "Where environmental information is concerned, Articles 6 and Article 7 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council shall also apply.
Slovenian: „Kadar gre za okoljske informacije, se uporabljata tudi člena 6 in 7 Uredbe (ES) št. 1367/2006 Evropskega parlamenta in Sveta.
English: (b) promote consistency and transparency in formulating risk management recommendations;
Slovenian: (b) spodbujanje doslednosti in preglednosti pri oblikovanju priporočil za obvladovanje tveganja;
English: [23: https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf.]
Slovenian: [23: https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_sl.pdf.]
English: Those items referred to in the first subparagraph shall be made public on a dedicated section of the Authority's website.
Slovenian: Dokumenti iz prvega pododstavka se objavijo na posebnem razdelku spletišča agencije.
English: Its mandate is broad and covers all issues impacting directly or indirectly on food and feed safety (including the evaluation of dossiers put forward for the approval of substances), animal health and animal welfare, plant health, human nutrition, and GMO issues.
Slovenian: Njena pooblastila so široka in zajemajo vsa vprašanja, ki neposredno ali posredno vplivajo na varnost živil in krme (vključno z oceno dokumentacije za odobritev snovi), zdravje in dobrobit živali, zdravje rastlin, prehrano ljudi in vprašanja na področju gensko spremenjenih organizmov.
English: Union Register of Studies
Slovenian: Register študij Unije
English: Implementation plans and monitoring, evaluation and reporting arrangements
Slovenian: Načrti za izvedbo ter ureditev spremljanja, ocenjevanja in poročanja
English: It is therefore necessary to strengthen the support provided by the Authority and the Member States to the work of the Authority's Scientific Panels.
Slovenian: Zato je treba okrepiti podporo, ki jo Agencija in države članice zagotavljajo za delo znanstvenih svetov Agencije.
English: The powers to adopt delegated acts referred to in Article 8(c) shall be conferred upon the Commission for an indeterminate period of time from [date of entry into force of this Regulation].
Slovenian: Pooblastilo za sprejemanje delegiranih aktov iz člena 8c se prenese na Komisijo za nedoločen čas od [datum začetka veljavnosti te uredbe].
English: - decisions, agreements and contracts resulting from the financing implementing activities of the Regulation will expressly entitle the Commission/EFSA, including OLAF, and the Court of Auditors to conduct audits, on-the-spot checks and inspections;
Slovenian: - v sklepih, sporazumih in pogodbah, ki izhajajo iz dejavnosti izvajanja financiranja iz Uredbe, bosta Komisija/EFSA, vključno z uradom OLAF, in Računsko sodišče izrecno pooblaščena za izvajanje revizij, pregledov na kraju samem in inšpekcijskih pregledov;
English: EFSA's evaluations of authorisation applications are essentially based on industry studies (burden of proof of safety of products on the applicant) also perceived as non-transparent by civil society.
Slovenian: Ocene agencije EFSA v zvezi z vlogami za odobritev v glavnem temeljijo na študijah industrije (dokazno breme o varnosti izdelkov nosi vlagatelj), ki jih civilna družba prav tako dojema kot nepregledne.
English: 3 17.03 11 European Food Safety Authority Diff.
Slovenian: 3 17.03 11 Evropska agencija za varnost hrane dif. DA NE NE NE
English: This means taking into account the general objectives of the GFL Regulation, namely a high level of protection of human health and consumers' interests and the effective functioning of the internal market.
Slovenian: To pomeni, da se upoštevajo splošni cilji uredbe o splošni živilski zakonodaji, torej visoka raven varovanja zdravja ljudi in interesov potrošnikov ter učinkovito delovanje notranjega trga.
English: Information requested to be treated as confidential in the confidential version shall be clearly marked.
Slovenian: Informacije, ki jih je treba obravnavati kot zaupne, morajo biti v zaupni različici jasno označene.
English: It is thus appropriate to include representatives of all Member States in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment.
Slovenian: Zato je v upravni odbor Agencije primerno vključiti predstavnike vseh držav članic, hkrati pa zagotoviti, da imajo navedeni predstavniki izkušnje zlasti na področju ocenjevanja tveganja.
English: DG SANTE actively monitors the compliance of agencies' independence policies with the Commission's guidelines on independence through a DG SANTE's task force including all SANTE's agencies and through bilateral contacts.
Slovenian: GD SANTE dejavno spremlja skladnost politik neodvisnosti v agencijah s smernicami Komisije o neodvisnosti prek svoje projektne skupine, ki vključuje vse agencije GD SANTE, in prek dvostranskih odnosov.
English: To ensure the transparency of this process, the advice of the Authority should be made public.
Slovenian: Za preglednost tega postopka bi bilo treba nasvet Agencije objaviti.
English: As risks due to an important exposure to potential conflicts of interest in EU decentralised agencies and Scientific Committees are assessed as significant (see DG SANTE's 2017 MP), DG SANTE's planned actions focus on improving the handling of conflict of interest situations.
Slovenian: Ker so tveganja zaradi velike izpostavljenosti morebitnim nasprotjem interesov v decentraliziranih agencijah EU in znanstvenih odborih ocenjena kot pomembna (glej načrt upravljanja 2017 GD SANTE), so predvideni ukrepi GD SANTE usmerjeni v izboljšanje obravnavanja primerov nasprotij interesov.
English: The risk of this tool being disproportionally used to unnecessarily commission studies is limited: it is to be triggered by the Commission since it will be financed by the Union budget and only in exceptional circumstances.
Slovenian: Tveganje, da bi se to orodje nesorazmerno uporabljalo za nepotrebno naročanje študij, je omejeno: ker se financira iz proračuna Unije, ga lahko uporabi Komisija in samo v izjemnih okoliščinah.
English: The Executive Director shall submit the list to the Management Board for appointment.
Slovenian: Izvršni direktor predloži seznam upravnemu odboru v imenovanje.
English: A number of impacts were however considered during the preparation process as follows:
Slovenian: Kljub temu pa so bili pri pripravi upoštevani številni učinki:
English: Globally, all these measures will also contribute to an increased involvement of stakeholders in the risk assessment system and thus to a more effective risk communication.
Slovenian: Skupaj bodo vsi ti ukrepi prispevali tudi k večji vključenosti zainteresiranih strani v sistem ocenjevanja tveganja in s tem k učinkovitejšemu obveščanju o tveganju.
English: The provisions of this Regulation shall not apply to applications for authorisations under Union food law as well as requests for scientific outputs submitted to the Authority prior to [general date of entry of application:18 months after its entry into force].
Slovenian: Določbe te uredbe se ne uporabljajo za vloge za odobritev na podlagi živilske zakonodaje Unije niti za zaprosila za znanstvene prispevke, predložene Agenciji pred [splošni datum začetka uporabe: 18 mesecev po začetku njene veljavnosti].
English: The challenges to be addressed related to transparency, sustainability of the EU risk assessment system (which for authorisations of products/substances is an EU centralised system, with the exception of pesticides dual system) and the demand for risk communication to be more effective.
Slovenian: Izzivi, ki jih je treba obravnavati v zvezi s preglednostjo in trajnostjo sistema EU za ocenjevanje tveganja (ki je za odobritve izdelkov/snovi centraliziran sistem EU, z izjemo dvojnega sistema za pesticide) ter potrebo po učinkovitejšem obveščanju o tveganju.
English: (33) Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to provide for a Commission evaluation of the Authority, in accordance with the Common Approach on Decentralised Agencies.
Slovenian: (33) Poleg tega je za oceno uspešnosti in učinkovitosti različnih določb, ki se uporabljajo za Agencijo, primerno tudi določiti, da Komisija oceni Agencijo, in sicer v skladu s skupnim pristopom k decentraliziranim agencijam.
English: In parallel to the legislative measures, the Commission will also continue to provide support to food safety via its Research and Innovation policies and contribute to strengthening coordination, cooperation and cohesion of food safety research and innovation activities in the Union and its Member States in particular when building the forthcoming ninth European Research and Innovation Framework Programme.
Slovenian: Vzporedno z zakonodajnimi ukrepi bo Komisija s svojimi politikami na področju raziskav in inovacij še naprej zagotavljala podporo varnosti hrane ter prispevala h krepitvi usklajevanja, sodelovanja in kohezije raziskovalnih in inovacijskih dejavnosti na področju varnosti hrane v Uniji in njenih državah članicah, zlasti pri oblikovanju prihodnjega devetega evropskega okvirnega programa za raziskave in inovacije.
English: (b) the names of authors of published, or publicly available, studies supporting such requests; and
Slovenian: (b) imena avtorjev objavljenih ali javno dostopnih študij v podporo takim zaprosilom ter
English: The proposal/initiative relates to a new action following a pilot project/preparatory action
Slovenian: Predlog/pobuda se nanaša na nov ukrep na podlagi pilotnega projekta/ pripravljalnega ukrepa.
English: The application provided for in Article 14 of this Regulation shall be submitted by a producer of the active substance to a Member State, with a copy to the other Member States, the Commission and the Authority, no later than three years before the expiry of the approval.
Slovenian: Zahtevek iz člena 14 te uredbe predloži proizvajalec aktivne snovi državi članici, pri čemer pošlje po en izvod drugim državam članicam, Komisiji in Agenciji, in sicer najpozneje tri leta pred iztekom odobritve.
English: (d) foster public understanding of the risk analysis process so as to enhance confidence in its outcome;
Slovenian: (d) povečanje razumevanja postopka analize tveganja v javnosti, da se poveča zaupanje v njegove rezultate;
English: Estimated requirements of human resources for the parent DG
Slovenian: Ocenjene potrebe po človeških virih za matični GD
English: Since some specific changes of EFSA's functioning (pre-submission advice, composition of the Panels) are proposed, care has been taken to take into account procedures followed by other scientific agencies with special attention to European Chemicals Agency (ECHA) and European Medicines Agency (EMA).
Slovenian: Ker so predlagane nekatere specifične spremembe v delovanju agencije EFSA (svetovanje pred vložitvijo vloge, sestava svetov), je bila pozornost namenjena upoštevanju postopkov drugih znanstvenih agencij, zlasti Evropske agencije za kemikalije (ECHA) in Evropske agencija za zdravila (EMA).
English: This proposal is addressing those challenges directly linked to the GFL Regulation and EFSA.
Slovenian: Ta predlog obravnava te izzive, ki so neposredno povezani z uredbo o splošni živilski zakonodaji in agencijo EFSA.
English: The Management Board shall adopt, on the basis of a proposal of the Executive Director, rules on the detailed organisation and timing of the procedures set up in paragraphs 5a and 5b of the present Article.
Slovenian: Upravni odbor na predlog izvršnega direktorja sprejme pravila za podrobno organizacijo in časovni načrt postopkov iz odstavkov 5a in 5b tega člena.
English: The assessment of the impacts outlines how the proposal achieves the best balance in meeting the objectives laid out by the initiative, ensuring benefits for citizens, stakeholders and Member States, while not significantly impacting on industry and innovation.
Slovenian: V oceni učinkov je opisano, kako se s predlogom najbolj uravnoteženo dosegajo cilji pobude, prinašajo koristi za državljane, zainteresirane strani in države članice, ne da bi predlog bistveno vplival na industrijo in inovacije.