FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: (c) provide a sound basis for understanding risk management decisions;
Slovenian: (c) zagotavljanje trdne podlage za razumevanje odločitev glede obvladovanja tveganja;
English: The notification of commissioned studies creates a minimal burden.
Slovenian: Obveščanje o naročenih študijah pomeni minimalno breme.
English: It has made major progress on increasing its scientific capacity of expertise, boosting the quality of its scientific outputs, expanding its collection of scientific data and developing and harmonising risk assessment methodologies.
Slovenian: Agencija je dosegla velik napredek pri krepitvi znanstvenega strokovnega znanja, izboljšanju kakovosti svojih znanstvenih prispevkov, razširitvi svoje zbirke znanstvenih podatkov ter razvoju in usklajevanju metodologij za oceno tveganja.
English: The use of the detection methods and the reproduction of the reference materials, provided under Article 5(3) and 17(3) for the purpose of applying this Regulation to the GMOs, food or feed to which an application refers, shall not be restricted by the exercise of intellectual property rights or otherwise."
Slovenian: Uporaba postopkov odkrivanja in razmnoževanje referenčnega materiala iz členov 5(3) in 17(3) za namene uporabe te uredbe za GSO, živila ali krmo, na katere se nanaša vloga, nista omejena z uveljavljanjem pravic intelektualne lastnine ali kako drugače."
English: (3) commercial information revealing sourcing, market shares or business strategy of the applicant; and,
Slovenian: (3) poslovnih informacij, ki razkrivajo vire, tržne deleže ali poslovno strategijo vlagatelja ter
English: This risk is also addressed by the better financial compensation of Member States contributing to EFSA's work by sending experts or providing preparatory work.
Slovenian: Za obravnavanje tega tveganja so predvidena tudi boljša finančna nadomestila za države članice, ki prispevajo k delu agencije EFSA z napotitvijo strokovnjakov ali pripravljalnim delom.
English: The system has thus to be strengthened and Member States should take a more active role to ensure that a sufficient pool of experts is available to meet the needs of the Union risk assessment system in terms of high level of scientific expertise, independence and multidisciplinary expertise.
Slovenian: Sistem je zato treba okrepiti, države članice pa bi morale imeti aktivnejšo vlogo pri zagotavljanju zadostnega nabora strokovnjakov za izpolnjevanje potreb sistema Unije za ocenjevanje tveganja v smislu visoke ravni strokovnega znanja, neodvisnosti in večdisciplinarnega strokovnega znanja.
English: Please note that inflation adjustments to the figures mentioned in the tables below, need to be considered as from the year 2023 onwards.
Slovenian: Za obdobje od leta 2023 naprej je treba pri številkah iz naslednjih tabel upoštevati inflacijske prilagoditve.
English: (b) results of production batches of the active substance including impurities; and,
Slovenian: (b) rezultatov proizvodnih serij aktivne snovi, vključno z nečistočami; ter
English: Given the problems identified above, the purpose of this Regulation is to introduce changes to the existing legal framework which are limited to what is strictly necessary to achieve the objectives set up for the initiative in order to improve citizen and stakeholder confidence in the transparency and sustainability of the Union approach towards food safety, notably in relation to risk assessment.
Slovenian: Glede na zgoraj navedene težave je namen te uredbe uvesti spremembe v sedanji pravni okvir, ki so omejene na to, kar je nujno potrebno za doseganje ciljev iz pobude, da bi se povečalo zaupanje državljanov in zainteresiranih strani v preglednost in trajnost pristopa Unije k varnosti hrane, zlasti v zvezi z oceno tveganja.
English: Accordingly, no personal data should be made publicly available under this Regulation, unless it is necessary and proportionate for the purposes of ensuring the transparency, independence and the reliability of the risk assessment process, while preventing conflicts of interests.
Slovenian: Zato v skladu s to uredbo nobeni osebni podatki ne bi smeli biti javno dostopni, razen če je to potrebno in sorazmerno za namene zagotavljanja preglednosti, neodvisnosti in zanesljivosti postopka ocenjevanja tveganja, pri čemer pa se preprečuje nasprotje interesov.
English: Such obligations avoid the unnecessary repetition of studies on vertebrates and enlarge the evidence base of EFSA, without jeopardising the competitiveness of the relevant applicant.
Slovenian: S takimi obveznostmi se prepreči nepotrebno ponavljanje študij na vretenčarjih in razširi dokazna podlaga za agencijo EFSA, ne da bi bila pri tem ogrožena konkurenčnost zadevnega vlagatelja.
English: Transitional measures
Slovenian: Prehodni ukrepi
English: This principle remains valid, but the concerns on the transparency and independence of industry-generated studies and data should be addressed.
Slovenian: To načelo še vedno velja, vendar pa bi se morali obravnavati pomisleki glede preglednosti in neodvisnosti študij in podatkov, ki jih pripravi industrija.
English: (7) Based on these general objectives and principles, a general plan on risk communication should be established in close cooperation with the Authority and the Member States, and following relevant public consultations.
Slovenian: (7) Na podlagi teh splošnih ciljev in načel bi bilo treba vzpostaviti splošni načrt obveščanja o tveganju v tesnem sodelovanju z Agencijo in državami članicami, po ustreznih javnih posvetovanjih.
English: (2) commercial links between a producer or importer and the applicant or the authorisation holder, where applicable;
Slovenian: (2) trgovinskih povezav med proizvajalcem ali uvoznikom in vlagateljem ali, kjer je primerno, imetnikom odobritve;
English: Moreover, public money should not be used to commission costly studies (several thousand to several million Euros) that will eventually help the industry to place a product on the market.
Slovenian: Poleg tega se javna sredstva ne bi smela uporabljati za naročanje dragih študij (v vrednosti več tisoč do več milijonov evrov), ki bodo na koncu industriji pomagale dati izdelek na trg.
English: It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.
Slovenian: Zlasti je pomembno, da se Komisija pri svojem pripravljalnem delu ustrezno posvetuje, tudi s strokovnjaki, in da se ta posvetovanja izvajajo v skladu z načeli iz Medinstitucionalnega sporazuma o boljši pripravi zakonodaje z dne 13. aprila 2016.
English: Member States were consulted in a meeting of the Expert Group on the General Food Law on 5 March 2018.
Slovenian: Posvetovanje z državami članicami je potekalo 5. marca 2018 na sestanku strokovne skupine o splošni živilski zakonodaji.
English: SPECIFIC OBJECTIVE No 1 improve and clarify the rules on transparency, especially with regard to the scientific studies supporting the risk assessment[48: As described in point 1.4.2.
Slovenian: SPECIFIČNI CILJ št. 1 izboljšati in pojasniti pravila o preglednosti, zlasti glede znanstvenih študij v podporo oceni tveganja[48: Kakor je opisan v točki 1.4.2 „Specifični cilji".]
English: 2) increase reliability, objectivity and independence of studies
Slovenian: 2) Povečati zanesljivost, objektivnost in neodvisnost študij
English: This in turn is expected to have a positive impact on the sustainability of the Union risk assessment system.
Slovenian: To naj bi imelo pozitiven učinek na vzdržnost sistema Unije za ocenjevanje tveganja.
English: Human Resources
Slovenian: Človeški viri
English: To guarantee maintenance of a high level of scientific expertise in EFSA and its risk assessment capacity to ensure the sustainability of the Union risk assessment system that is the basis of all measures taken on food safety.
Slovenian: Zagotovitev ohranjanja visoke ravni strokovnega znanja v agenciji EFSA in njene zmogljivosti za ocenjevanje tveganja za trajnost sistema Unije za ocenjevanje tveganja, ki je podlaga za vse ukrepe, sprejete na področju varnosti hrane.
English: Decisions taken by the Authority pursuant to this Article may be subject to an action before the Court of Justice of the European Union, under the conditions laid down in Articles 263 and 278 of the Treaty respectively.
Slovenian: Zoper odločitve, ki jih agencija sprejme v skladu s tem členom, se lahko vloži tožba pred Sodiščem Evropske unije pod pogoji, določenimi v členu 263 oziroma členu 278 Pogodbe.
English: Enhanced transparency is expected to contribute to strengthening a climate of consumers' confidence that is beneficial for stimulating innovation and for the Union product safety recognition worldwide.
Slovenian: Večja preglednost naj bi prispevala h krepitvi ozračja zaupanja potrošnikov, ki je ugodno za spodbujanje inovacij in za mednarodno priznavanje varnosti proizvodov v Uniji.
English: 1) The proposal ensures that scientists and citizens have access to key safety related information being assessed by EFSA at an early stage of the risk assessment.
Slovenian: 1) Predlog znanstvenikom in državljanom zagotavlja dostop do ključnih informacij, povezanih z varnostjo, ki jih ocenjuje EFSA na začetni stopnji ocene tveganja.
English: The studies commissioned may have a wider scope than the evidence subject to verification.
Slovenian: Naročene študije so lahko obširnejše kot dokaz, ki se preverja.
English: strengthen the ability of EFSA to maintain a high level of scientific expertise in the different areas of its work, especially its capacity to attract excellent scientists to be members of its Scientific Panels; bearing the related financial and budgetary aspects in mind too, and,
Slovenian: okrepitve zmogljivosti agencije EFSA za ohranjanje visoke ravni strokovnega znanja na različnih področjih njenega dela, zlasti njene zmožnosti privabljanja odličnih znanstvenikov k članstvu v znanstvenih svetih; in tudi upoštevanja zadevnih finančnih in proračunskih vidikov ter
English: (a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and,
Slovenian: (a) informacij o zaporedju DNK, razen zaporedjih, ki se uporabljajo za odkrivanje, identifikacijo in količinsko določanje transformacijskega dogodka, ter
English: EFSA is currently empowered to communicate on its own initiative in the fields within its mission, without prejudice to the Commission's competence to communicate its risk management decisions.
Slovenian: EFSA je trenutno pooblaščena, da na lastno pobudo izvaja dejavnosti obveščanja na področjih svojega poslanstva, ne da bi pri tem posegala v pristojnost Komisije obveščanja o odločitvah glede obvladovanja tveganja.
English: Member States shall ensure that the public bodies employing those scientific experts and those having responsibility for the setting of priorities of the scientific bodies employing those experts implement the measures provided for in paragraph 5d.
Slovenian: Države članice zagotovijo, da javni organi, ki zaposlujejo navedene znanstvene strokovnjake, in pristojni za določanje prednostnih nalog znanstvenih organov, ki zaposlujejo navedene strokovnjake, izvajajo ukrepe iz odstavka 5d.
English: Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available).
Slovenian: Upoštevati bi bilo treba dejstvo, da mora biti področje uporabe naročenih študij v nekaterih posebnih primerih širše od zadevnega dokaza (če so na primer na voljo nova znanstvena dognanja).
English: Since they concern the authorisation of a substance already on the market for several years and given that they address planned studies, the experience from the similar procedures under ECHA shows that there is public knowledge and in some cases new data that can be usefully shared concerning the substance at issue.
Slovenian: Ker se te obveznosti nanašajo na odobritev snovi, ki je na trgu že več let, in glede na to, da se nanašajo na načrtovane študije, izkušnje s podobnimi postopki v primeru agencije ECHA kažejo, da je na voljo javno znanje in v nekaterih primerih novi podatki o zadevni snovi, ki so lahko koristni.
English: In that respect, the proposal sets outs which type of information is to be considered confidential.
Slovenian: V zvezi s tem ta predlog določa, katere vrste informacij je treba obravnavati kot zaupne.
English: The Member States shall put in place measures ensuring that the members of the Scientific Panels act independently and remain free from conflict of interests as provided for in Article 37(2) and the Authority's internal measures.
Slovenian: Države članice sprejmejo ukrepe, ki zagotavljajo, da člani znanstvenih svetov delujejo neodvisno in brez nasprotja interesov, kakor je določeno v členu 37(2) ter notranjih ukrepih agencije.
English: (b) information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable health effects.
Slovenian: (b) informacije, ki so del ugotovitev znanstvenih prispevkov, vključno z znanstvenimi mnenji, ki jih je izdala agencija in se nanašajo na predvidljive učinke na zdravje.
English: Dependence on a small number of Member States that provide more than two thirds of the EFSA's Scientific Panels' experts and difficulties in receiving sufficient support from many Member States for its scientific work (e.g. by providing studies, or data).
Slovenian: odvisnost od majhnega števila držav članic, ki prispevajo več kot dve tretjini strokovnjakov v znanstvene svete agencije EFSA, ter nezadostna podpora iz številnih držav članic pri njenem znanstvenem delu (npr. s pripravo študij ali podatkov).
English: Transparency: The proposal aims at strengthening the transparency of the risk assessment process.
Slovenian: Preglednost: S predlogom naj bi se povečala preglednost postopka ocene tveganja.
English: Laboratory related audit can be performed by existing service SANTE.F "Health and Food audits and analysis".
Slovenian: Presoje v zvezi z laboratoriji lahko izvaja obstoječa služba GD SANTE za presoje in analize na področju zdravja in hrane (direktorat F).
English: It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein.
Slovenian: Sklep začne učinkovati dan po njegovi objavi v Uradnem listu Evropske unije ali na poznejši dan, ki je določen v navedenem sklepu.
English: Divergences between Union and national risk assessors, however, do not necessarily question the work of the different scientific bodies.
Slovenian: Razhajanja med odgovornimi za oceno tveganja na nacionalni ravni in ravni Unije pa nujno ne prinašajo dvomov o delu različnih znanstvenih organov.
English: This is because companies going to laboratories outside the Union would take the risk to be perceived as evading the rules.
Slovenian: Podjetja, ki se odločijo za laboratorije zunaj Unije, bi namreč tvegala, da bi se tako ravnanje lahko razumelo kot izogibanje pravilom.
English: Standard data formats
Slovenian: Standardne oblike zapisa podatkov
English: Moreover, as indicated in the GFL Fitness Check, food and feed safety measures have the greatest effect when taken at Union level.
Slovenian: Poleg tega imajo, kot je bilo ugotovljeno pri preverjanju ustreznosti splošne živilske zakonodaje, ukrepi za varnost živil in krme največji učinek, kadar so sprejeti na ravni Unije.
English: By strengthening the EFSA's governance and making risk assessment more sustainable, it will ensure that EFSA will continue to play a fundamental role in the Union food safety system and to contribute to the health and wellbeing of Union citizens and to an innovative and competitive Union agri-food industry.
Slovenian: Predlog bo z okrepitvijo upravljanja agencije EFSA in povečanjem vzdržnosti sistema ocenjevanja tveganja zagotovil, da bo EFSA še naprej imela pomembno vlogo v sistemu Unije za varnost hrane ter prispevala k zdravju in dobrobiti državljanov Unije ter k inovativni in konkurenčni agroživilski industriji Unije.
English: It is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby Member State controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the Commission.
Slovenian: Primerno je določiti dodatno raven jamstev, da bi splošni javnosti dali zagotovila glede kakovosti študij in določili okrepljen sistem presoj, v skladu s katerim bi Komisija preverjala nadzor držav članic nad izvajanjem navedenih načel v laboratorijih, ki izvajajo take študije in preizkuse.
English: Those members shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes more names than there are posts to be filled.
Slovenian: Navedene člane imenuje Svet po posvetovanju z Evropskim parlamentom na podlagi seznama, ki ga sestavi Komisija in vključuje več imen, kot je prostih delovnih mest.
English: (b) Taking into account the applicable requirements in the different authorisation procedures and other legislative frameworks and following any necessary adaptations, the Commission shall adopt standard data formats and software by means of implementing acts.
Slovenian: (b) Ob upoštevanju veljavnih zahtev v različnih odobritvenih postopkih in drugih zakonodajnih okvirov ter po vseh potrebnih prilagoditvah Komisija z izvedbenimi akti sprejme standardne oblike zapisa podatkov in programsko opremo.
English: There is only a very limited risk that notification by laboratories, meaning only Union laboratories, could have negative impacts on their competitiveness vis-à-vis non-Union laboratories, or that the overall effectiveness of the measure may be undermined by applicants deciding to carry out studies in laboratories outside the Union to circumvent the notification obligation.
Slovenian: Obstaja le zelo majhno tveganje, da bi obveznost obveščanja za laboratorije, tj. samo laboratorije Unije, lahko negativno vplivala na njihovo konkurenčnost v primerjavi z neunijskimi laboratoriji ali da bi skupno učinkovitost ukrepa lahko ogrozili vlagatelji, ki se odločijo, da bodo študije izvedli v laboratorijih zunaj Unije ter se tako izognili obveznosti obveščanja.
English: The Authority shall lay down in its internal rules the practical arrangements for implementing the notification obligations laid down in paragraphs 1 and 2, including consequences of non-compliance with the notification obligation.
Slovenian: Agencija v svojem poslovniku določi praktično ureditev za izvajanje obveznosti uradnega obveščanja iz odstavkov 1 in 2, vključno s posledicami neizpolnjevanja obveznosti uradnega obveščanja.
English: The application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application.
Slovenian: Vloga se šteje za umaknjeno od trenutka, ko pristojni organ, ki je prejel prvotno vlogo, prejme pisno zahtevo.
English: (1) Regulation (EC) No 178/2002 of the European Parliament and of the Council lays down the general principles and requirements of food law, so as to form a common basis for measures governing food law both at Union and Member State level.
Slovenian: (1) Uredba (ES) št. 178/2002 Evropskega parlamenta in Sveta določa splošna načela in zahteve živilske zakonodaje, da se oblikuje skupna podlaga za ukrepe glede živilske zakonodaje tako na ravni Unije kot na ravni držav članic.
English: The register of commissioned studies will have a positive impact on the objectivity of the evidence submitted by industry since it will provide additional guarantee that applicants submit all studies they have performed on a substance -whatever their results.
Slovenian: Register naročenih študij bo pozitivno vplival na objektivnost dokazov, ki jih predloži industrija, saj bo pomenil dodatno jamstvo, da vlagatelji predložijo vse študije, ki so jih izvedli v zvezi snovjo - ne glede na njihove rezultate.
English: (1) the method and other technical and industrial specifications relating to that method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion;
Slovenian: (1) metode ter drugih tehničnih in industrijskih specifikacij za navedeno metodo, uporabljeno za izdelavo ali proizvodnjo predmeta, na katerega se nanaša zaprosilo za znanstveni prispevek, vključno z znanstvenim mnenjem;
English: Transparency and confidentiality
Slovenian: Preglednost in zaupnost
English: (10) It is appropriate to align the composition of the Management Board of the Authority to the Common Approach on decentralised agencies, in accordance with the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies of 2012.
Slovenian: (10) Sestavo upravnega odbora Agencije je primerno uskladiti s skupnim pristopom k decentraliziranim agencijam, v skladu s skupno izjavo Evropskega parlamenta, Sveta Evropske unije in Evropske komisije o decentraliziranih agencijah iz leta 2012.
English: At the same time, the proposal is expected to ensure the long-term sustainability of EFSA's capacity of scientific expertise.
Slovenian: S predlogom pa naj bi hkrati zagotovili dolgoročno trajnost zmogljivosti agencije EFSA za ohranjanje strokovnega znanja.
English: Given the targeted nature of this revision, focussing on transparency, the main simplification aspect concerns the introduction of a pre-submission advice which should provide support to applicants, in particular SMEs, to better understand the specifications on content of applications.
Slovenian: Ker je ta revizija usmerjena v preglednost, se glavni vidik poenostavitve nanaša na uvedbo svetovanja pred vložitvijo vloge, s katerim bi se morala zagotoviti podpora vlagateljem, zlasti MSP, da bi bolje razumeli specifikacije glede vsebine vlog.
English: (4) quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion.
Slovenian: (4) kvantitativne sestave predmeta, na katerega se nanaša zaprosilo za znanstveni prispevek, vključno z znanstvenim mnenjem.
English: Recent debates raised concerns on transparency and independence of industry-generated studies and data.
Slovenian: V nedavnih razpravah so bili izraženi pomisleki glede preglednosti in neodvisnosti študij in podatkov industrije.
English: (b) specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment.
Slovenian: (b) specifikacij nečistoč aktivne snovi in ustreznih metod analize, ki jih je vložnik interno razvil, razen nečistoč, ki bi lahko imele škodljive učinke na zdravje živali, zdravje ljudi ali okolje.
English: The EFSA's effectiveness depends on its capacity to attract and pool expertise from Member States.
Slovenian: Učinkovitost agencije EFSA je odvisna od njene zmožnosti, da pritegne in združi strokovno znanje iz držav članic.
English: The Authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment.
Slovenian: Agencija že pregleduje znanstveno literaturo, da bi lahko upoštevala druge podatke in študije o predmetu, na katerega se nanaša njena ocena.
English: [19: OJ C , , p.
Slovenian: [19: UL C , , str.
English: (iii) Meeting the needs for the specific multi-disciplinary expertise of the Panel to which they will be appointed and the applicable language regime.
Slovenian: (iii) izpolnjevanje potreb po posebnih večdisciplinarnih strokovnih znanjih znanstvenega sveta, v katerega bodo imenovani, in potreb veljavne jezikovne ureditve.
English: (b) provide transparent information at each stage of the risk analysis process from the framing of requests for scientific advice to the provision of risk assessment and the adoption of risk management decisions;
Slovenian: (b) zagotavljati pregledne informacije na vsaki stopnji postopka analize tveganja, od oblikovanja zaprosil za znanstveno mnenje do predložitve ocene tveganja in sprejetja odločitev o obvladovanju tveganja;
English: For the purposes of risk assessment at Union level, it establishes the European Food Safety Authority ("the Authority"), as the responsible Union risk assessment body in matters relating to food and feed safety.
Slovenian: Za namene ocene tveganja na ravni Unije ustanavlja Evropsko agencijo za varnost hrane (v nadaljnjem besedilu: Agencija) kot pristojni organ Unije za ocenjevanje tveganja glede zadev, povezanih z varnostjo hrane in krme.
English: (13) The Fitness Check of the General Food Law identified certain shortcomings in the long-term capability of the Authority to maintain its high-level expertise.
Slovenian: (13) Pri preverjanju ustreznosti splošne živilske zakonodaje so bile ugotovljene nekatere pomanjkljivosti pri dolgoročni zmogljivosti Agencije za ohranjanje strokovnega znanja na visoki ravni.
English: The GFL Fitness Check and recent public debates have shown that certain aspects of the current legislative framework need to be addressed.
Slovenian: Pri preverjanju ustreznosti splošne živilske zakonodaje in v nedavnih javnih razpravah se je pokazalo, da je treba obravnavati nekatere vidike sedanjega zakonodajnega okvira.
English: (30) It is also necessary to set out specific requirements with respect to the protection of personal data for the purposes of the transparency of the risk assessment process taking into account Regulation (EC) No 45/2001 of the European Parliament and of the Council and Regulation (EU) 2016/679 of the European Parliament and of the Council.
Slovenian: (30) Prav tako je treba določiti posebne zahteve v zvezi z varstvom osebnih podatkov za namene preglednosti postopka ocenjevanja tveganja ob upoštevanju Uredbe (ES) št. 45/2001 Evropskega parlamenta in Sveta in Uredbe (EU) 2016/679 Evropskega parlamenta in Sveta.
English: The option having Member States requesting EFSA to commission studies in exceptional circumstances as well as the option having EFSA commissioning such studies on its own motion were not chosen in the end for reasons of proportionality (public financing) but also because the EFSA and Member States can already signal to the Commission specific reasons to make use of this specific tool.
Slovenian: Možnost, da lahko države članice od agencije EFSA zahtevajo, da naroči študije v izjemnih okoliščinah, ter možnost, da lahko EFSA naroča take študije na lastno pobudo, na koncu nista bili izbrani zaradi sorazmernosti (javno financiranje), pa tudi zato, ker lahko EFSA in države članice že zdaj Komisijo opozorijo na posebne razloge za uporabo tega specifičnega orodja.
English: Those arrangements shall however be in accordance with the present Regulation and other Union sectoral food law.
Slovenian: Navedena ureditev je v skladu s to uredbo in drugo sektorsko živilsko zakonodajo Unije.
English: EFSA has in place and strictly monitors its rules on "independence" and "conflict of interest"; Control method(s) envisaged
Slovenian: EFSA ima vzpostavljena pravila o „neodvisnosti" in „nasprotju interesov", ki jih pozorno spremlja; načrtovani načini kontrole
English: Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Inter-institutional Agreement on Better Law-Making of 13 April 2016.
Slovenian: Komisija se pred sprejetjem delegiranega akta posvetuje s strokovnjaki, ki jih imenuje posamezna država članica, v skladu z načeli iz Medinstitucionalnega sporazuma o boljši pripravi zakonodaje z dne 13. aprila 2016.
English: (7) the following Articles 39a to 39g are inserted:
Slovenian: (7) vstavijo se naslednji členi 39a do 39g:
English: Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.
Slovenian: Navedite, kakšne posledice naj bi imel(-a) predlog/pobuda za upravičence/ciljne skupine.
English: The impetus for the GFL Regulation came from a succession of food related crises, notably the Bovine Spongiform Encephalopathy (BSE) crisis, foot and mouth disease and dioxin in the late 90s-early 2000s.
Slovenian: Povod za uredbo o splošni živilski zakonodaji je bila vrsta prehranskih kriz v poznih devetdesetih letih 20. in v začetku 21. stoletja, zlasti kriza v zvezi z govejo spongiformno encefalopatijo (BSE), slinavko in parkljevko ter dioksinom.
English: The term of office of the members referred to in paragraph 1a(c) may be renewable only once.
Slovenian: Mandat članov iz odstavka 1a(c) se lahko samo enkrat podaljša.
English: (3) The evaluation of Regulation (EC) No 178/2002, ("Fitness Check of the General Food Law"), found that risk communication is overall, not considered to be effective enough, which has an impact on consumers' confidence on the outcome of the risk analysis process.
Slovenian: (3) Pri oceni Uredbe (ES) št. 178/2002 („preverjanje ustreznosti splošne živilske zakonodaje") je bilo ugotovljeno, da se obveščanje o tveganju na splošno ne šteje za dovolj učinkovito, kar vpliva na zaupanje potrošnikov v rezultat postopka analize tveganja.
English: [20: OJ C , , p.
Slovenian: [20: UL C , , str.
English: (39) The appointment of the Scientific Committee and Scientific Panels' members being dependent of the entry in function of the new Management Board, it is necessary to provide for specific transitional provisions allowing a prolongation of the current term of office of the members of the Scientific Committee and Scientific Panels members.
Slovenian: (39) Ker je imenovanje članov znanstvenega odbora in znanstvenih svetov odvisno od začetka delovanja novega upravnega odbora, je treba določiti posebne prehodne določbe, ki omogočajo podaljšanje sedanjega mandata članov znanstvenega odbora in znanstvenih svetov.
English: With respect to requests for scientific outputs, including scientific opinions under Union food law, the Authority shall always make public:
Slovenian: V zvezi z zaprosili za znanstvene prispevke, med drugim tudi za znanstvena mnenja na podlagi živilske zakonodaje Unije, agencija vedno objavi:
English: The consultation on submitted studies does not create additional burdens since the obligation to submit studies to EFSA, Commission and Member States already exists.
Slovenian: Posvetovanje o predloženih študijah ne bo povzročilo dodatnega bremena, saj že obstaja obveznost predložitve študij agenciji EFSA, Komisiji in državam članicam.
English: (a) identify the key factors that need to be taken into account when considering the type and level of risk communications' activities needed;
Slovenian: (a) opredeljeni ključni dejavniki, ki jih je treba upoštevati pri določanju vrste in ravni potrebnih dejavnosti obveščanja o tveganju;
English: Regulation (EC) No 178/2002 on general food law (the "GFL" Regulation) provides for a comprehensive harmonised legal framework.
Slovenian: Uredba (ES) št. 178/2002 o splošni živilski zakonodaji („uredba o splošni živilski zakonodaji") določa celovit in usklajen pravni okvir.
English: Alternatives considered:
Slovenian: Obravnavane alternativne možnosti:
English: The risk that some Member States might not have enough experts to be able to provide the EFSA with valuable candidates is alleviated by the possibility for EFSA to select and appoint additional experts of its own accord and the possibility for Member States to appoint experts who have the nationality of other Member States.
Slovenian: Tveganje, da nekatere države članice morda nimajo dovolj strokovnjakov, da bi lahko agenciji EFSA zagotovile ustrezne kandidate, se izravna z možnostjo, da lahko EFSA sama izbere in imenuje dodatne strokovnjake, ter možnostjo, da države članice imenujejo strokovnjake z državljanstvom druge države članice.
English: The Executive Director may not draw up such a list where he/she can justify that the nominations received do not allow him, given the criteria for selection set up in point d) of this paragraph, to draw up a larger list.
Slovenian: Izvršni direktor ne sme pripraviti takega seznama, kadar lahko utemelji, da na podlagi prejetih predlogov ne more pripraviti daljšega seznama glede na merila za izbor iz točke (d) tega odstavka.
English: On transparency, the measures envisaged (i.e. proactive disclosure of non-confidential data, register of commissioned studies, voluntary pre-submission procedure, pre-notification of, and advice on planned studies in case of renewals, consultation of third parties on submitted studies) provide a robust framework which is proportional to the objective of enhancing citizens' confidence in the transparency of the system.
Slovenian: Kar zadeva preglednost, se s predvidenimi ukrepi (na primer proaktivno razkritje nezaupnih podatkov, register naročenih študij, prostovoljni postopek pred vložitvijo vloge, predhodno obveščanje in svetovanje o načrtovanih študijah v primeru obnovitev, posvetovanje s tretjimi osebami o predloženih študijah) vzpostavlja trden okvir, ki je sorazmeren s ciljem krepiti zaupanje državljanov v preglednost sistema.
English: (37) In order to further strengthen the link between risk assessors and risk managers at Union and national levels as well as the coherence and consistency of risk communication, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain.
Slovenian: (37) Da bi še dodatno okrepili povezavo med odgovornimi za oceno tveganja in odgovornimi za obvladovanje tveganja na ravni Unije in nacionalnih ravneh ter skladnost in doslednost obveščanja o tveganju, bi bilo treba na Komisijo prenesti pooblastilo, da v skladu s členom 290 Pogodbe sprejme akte za sprejetje splošnega načrta za obveščanje o tveganju glede zadev, povezanih z agroživilsko verigo.
English: It is appropriate to lay down in Regulation (EC) No 178/2002 a horizontal list of information items whose disclosure may be considered to significantly harm the commercial interests concerned and should not therefore be disclosed to the public, ("general horizontal list of confidential items").
Slovenian: V Uredbi (ES) št. 178/2002 je primerno določiti horizontalni seznam informacij, katerih razkritje bi lahko veljalo za zelo škodljivo za zadevne poslovne interese in ki se zato ne bi smele razkriti javnosti („splošni horizontalni seznam zaupnih postavk").
English: There are still strong memories of the damage caused by successive food safety crises prior to the GFL Regulation which undermined the credibility of the Union to ensure that food is safe.
Slovenian: Še dobro pomnijo škodo, ki so jo povzročile številne krize na področju varnosti hrane spred sprejetjem uredbe o splošni živilski zakonodaji, ki so omajale verodostojnost Unije, da je zmožna zagotavljati varno hrano.
English: These developments took place against the backdrop of public controversy over the approach towards the assessment and management of sensitive substances such as genetically modified organisms, and plant protection products, especially those containing glyphosate or potentially negative health impacts arising from endocrine disruptors.
Slovenian: To dogajanje je sovpadalo z javno polemiko glede pristopa k ocenjevanju občutljivih snovi in ravnanju z njimi, na primer gensko spremenjenih organizmov in fitofarmacevtskih sredstev, zlasti tistih, ki vsebujejo glifosat ali imajo potencialno negativne učinke na zdravje, ki jih povzročajo endokrini motilci.
English: The Executive Director shall inform the Management Board of the requests sent to the Member States.
Slovenian: Izvršni direktor obvesti upravni odbor o zaprosilih, poslanih državam članicam.
English: XX 01 04 yy[50: Sub-ceiling for external staff covered by operational appropriations (former ‘BA' lines).]
Slovenian: XX 01 04 yy[50: Dodatna zgornja meja za zunanje sodelavce v okviru odobritev za poslovanje (prej vrstice BA).]
English: Function group and grade Year
Slovenian: Funkcionalna skupina in razred Leto
English: Citizens / civil society perceive the risk assessment process as opaque and demand more transparency, due to several different transparency and confidentiality rules applicable to risk assessment and decision-making process, making the system complex and non-uniform.
Slovenian: Državljani/civilna družba postopek ocenjevanja tveganja dojemajo kot nepregleden in zahtevajo večjo preglednost zaradi različnih pravil o preglednosti in zaupnosti, ki se uporabljajo za postopek ocenjevanja tveganja in odločanja, zaradi česar je sistem zapleten in neenoten.
English: The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests.
Slovenian: Pri oceni bi bilo zlasti treba pregledati postopke za izbor članov znanstvenega odbora in svetov, njihovo stopnjo preglednosti, stroškovno učinkovitost in primernost, da se zagotovita neodvisnost in usposobljenost ter preprečijo nasprotja interesov.
English: The list of information referred to in paragraph 2 shall be without prejudice to any specific Union food law.
Slovenian: Seznam informacij iz odstavka 2 ne posega v nobeno posebno živilsko zakonodajo Unije.
English: It is therefore essential to maintain the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation and independence of the Authority and transparency.
Slovenian: Zato je bistveno ohraniti zaupanje splošne javnosti in drugih zainteresiranih strani v postopek analize tveganja, na katerem temelji živilska zakonodaja Unije, in zlasti v ocenjevanje tveganja, vključno z organizacijo in neodvisnostjo Agencije ter preglednostjo.
English: Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, and 168(4)(b) thereof,
Slovenian: ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti člena 43, člena 114 in člena 168(4)(b) Pogodbe,
English: The Commission, in close cooperation with the Authority, the Member States and following appropriate public consultations shall be empowered to adopt delegated acts in accordance with Article 57a establishing a general plan for risk communication on matters relating to the agri-food chain, taking into account the relevant objectives and general principles set out in Articles 8a and 8b.
Slovenian: Komisija je v skladu s členom 57a pooblaščena, da v tesnem sodelovanju z agencijo, državami članicami in po ustreznih javnih posvetovanjih sprejme delegirane akte o določitvi splošnega načrta obveščanja o tveganju glede zadev v zvezi z agroživilsko verigo, ob upoštevanju zadevnih ciljev in splošnih načel iz členov 8a in 8b.
English: Indeed, the science-based approach to food legislation, underpinned by the establishment and operation of EFSA at centralised level, has overall improved the scientific basis of measures taken in the area of food law and has further contributed to harmonised views between Member States on key safety issues as well as to the Union product safety recognition worldwide.
Slovenian: Dejansko se je s znanstvenim pristopom k živilski zakonodaji, ki je temeljil na ustanovitvi in delovanju agencije EFSA na centralizirani ravni, na splošno izboljšala znanstvena podlaga za ukrepe, sprejete na področju živilske zakonodaje, prispeval pa je tudi k nadaljnji uskladitvi stališč med državami članicami o ključnih varnostnih vprašanjih ter k mednarodnemu priznanju varnosti proizvodov v Uniji.
English: persons entrusted with the implementation of specific actions in the CFSP pursuant to Title V of the TEU, and identified in the relevant basic act.
Slovenian: osebam, pooblaščenim za izvajanje določenih ukrepov SZVP v skladu z naslovom V PEU in opredeljenim v zadevnem temeljnem aktu.
English: Amendments to Regulation (EC) No 178/2002
Slovenian: Spremembe Uredbe (ES) št. 178/2002
English: (c) The Authority shall make the standard data formats and software packages, as adopted, available on its website.
Slovenian: (c) Agencija da standardne oblike zapisa podatkov in pakete programske opreme, kot so bili sprejeti, na voljo na svojem spletišču.
English: (21) Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law usually comply with internationally recognised principles, which provide a uniform basis for their quality in particular in terms of reproducibility of results.
Slovenian: (21) Študije, vključno s preizkusi, ki jih predložijo nosilci dejavnosti v podporo vlogam za odobritev na podlagi sektorske živilske zakonodaje Unije, so običajno v skladu z mednarodno priznanimi načeli, ki zagotavljajo enotno podlago za njihovo kakovost, zlasti z vidika ponovljivosti rezultatov.
English: There is no risk of duplication with the actual capacity of EFSA to commission scientific studies necessary for the performance of its mission (Article 32 of the GFL Regulation) as this is to be considered as a risk management tool.
Slovenian: Ni tveganja, da bi prišlo do podvajanja dela z dejansko nalogo agencije EFSA, da naroči znanstvene študije, potrebne za izvajanje svojega poslanstva (člen 32 uredbe o splošni živilski zakonodaji), saj se to orodje obravnava kot orodje za obvladovanje tveganja.
English: (b) all its scientific outputs, including the opinions of the Scientific Committee and the Scientific Panels after adoption, minority opinions and results of consultations performed during the risk assessment process always being included;
Slovenian: (b) vse svoje znanstvene prispevke, vključno z mnenji znanstvenega odbora in znanstvenih svetov po njihovem sprejetju, pri čemer vedno priloži manjšinska mnenja in rezultate posvetovanj, opravljenih med postopkom ocenjevanja tveganja;
English: Nevertheless, the following challenges have been identified: national differences in the implementation of the GFL Regulation at Member State level have been observed, creating in some instances uneven playing field for businesses; a perceived lack of transparency of the risk analysis process; risk communication is, overall, considered not to be effective enough, thus creating a negative impact on consumers' confidence and on the acceptability of risk management decisions; certain limitations in EFSA's capacity to ensure in the long-term sufficient expertise and to fully engage all Member States in scientific cooperation; lengthy authorisation procedures in some sectors.
Slovenian: Kljub temu pa so bili opredeljeni naslednji izzivi: opažene so bile nacionalne razlike pri izvajanju uredbe o splošni živilski zakonodaji na ravni držav članic, kar v nekaterih primerih ustvarja neenake konkurenčne pogoje za podjetja; postopek analize tveganja se dojema kot ne dovolj pregleden; obveščanje o tveganju na splošno velja za ne dovolj učinkovito, kar ustvarja negativen učinek na zaupanje potrošnikov in na sprejemljivost odločitev o obvladovanju tveganja; nekatere omejitve zmogljivosti agencije EFSA za dolgoročno zagotavljanje ustreznega strokovnega znanja in pritegnitev vseh držav članic k znanstvenemu sodelovanju; dolgotrajni postopki odobritve v nekaterih sektorjih.
English: The Executive Director shall notify the Member States of the Authority's independence policy and implementing rules applicable to Scientific Panels' members.
Slovenian: Izvršni direktor obvesti države članice o politiki neodvisnosti agencije in izvedbenih pravilih, ki se uporabljajo za člane znanstvenih svetov.
English: To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned.
Slovenian: Zato je potrebno in primerno, da nosilci dejavnosti, ki naročijo študije, in laboratoriji, ki te študije izvajajo, študije ob naročilu priglasijo Agenciji.
English: These can be explained by a variety of factors including for instance: the legal framework to which the question refers, the type of question put to scientific bodies by the relevant risk managers and how these are framed, whether the assessment relates to a hazard or a risk, the methodologies followed, or the data, which are utilised.
Slovenian: To je mogoče pojasniti z več dejavniki, med drugim: s pravnim okvirom, na katerega se nanaša vprašanje; z vrsto vprašanja, ki ga zadevni odgovorni za obvladovanje tveganja predložijo znanstvenim organom, ter način njegovega oblikovanja; ali se ocena nanaša na nevarnost ali tveganje; z uporabljenimi metodologijami ali podatki.
English: Amendments to Directive (EC) 2001/18/EC on the deliberate release into the environment of genetically modified organisms
Slovenian: Spremembe Direktive 2001/18/ES o namernem sproščanju gensko spremenjenih organizmov v okolje
English: (b) any provisions set out in Union food law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations (‘data exclusivity rules').
Slovenian: (b) katere koli določbe iz živilske zakonodaje Unije, ki ščitijo naložbe inovatorjev v zbiranje informacij in podatkov v podporo zadevnim vlogam za odobritev („pravila o izključnosti podatkov").
English: [24: Communication from the Commission on the ECI "Ban glyphosate and protect people and the environment from toxic pesticides", C(2017) 8414 final.]
Slovenian: [24: Sporočilo Komisije o evropski državljanski pobudi „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi", C(2017) 8414 final.]
English: The members of the Management Board and where relevant, the alternate members shall be appointed taking into account high competence in the area of food safety risk assessment as well as competences in the food chain safety legislation and policy, and relevant managerial, administrative and budgetary/financial skills.
Slovenian: Člani upravnega odbora in, kadar je ustrezno, nadomestni člani so imenovani na podlagi visoke usposobljenosti na področju ocenjevanja tveganja v zvezi z varnostjo hrane, pa tudi znanja na področju zakonodaje o varnosti prehranske verige in s tem povezane politike ter ustreznih vodstvenih, upravnih in proračunskih/finančnih sposobnosti.
English: EFSA's independence will not be affected to any extent since the scope of the advice that EFSA provides is limited to what the relevant provisions are and what the required content of the application at stake is.
Slovenian: Neodvisnost agencije EFSA ne bo v nobenem smislu ogrožena, saj je svetovanje agencije EFSA omejeno na zadevne določbe in na zahtevano vsebino zadevne vloge.
English: By way of derogation from Article 38, the Authority shall not make public information for which confidential treatment has been requested under the conditions laid down in this Article.
Slovenian: Z odstopanjem od člena 38 agencija ne objavi informacij, za katere se zahteva zaupna obravnava pod pogoji iz tega členu.
English: Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market.
Slovenian: Poleg tega se javna sredstva ne bi smela uporabljati za naročanje dragih študij, ki bodo na koncu industriji pomagale dati izdelek na trg.
English: As explained in the Roadmap, no impact assessment was carried out for this initiative, as the measures that are to be introduced by the proposal will mainly concern the transparency and the way the Commission as risk manager and the EFSA as risk assessor will gather and manage the evidence needed to perform their tasks on the basis of unchanged criteria.
Slovenian: Kot je pojasnjeno v časovnem načrtu, za to pobudo ni bila izvedena ocena učinka, saj se bodo ukrepi, ki bodo uvedeni s predlogom, v glavnem nanašali na preglednost in način, kako Komisija kot odgovorna za obvladovanje tveganja in EFSA kot odgovorna za oceno tveganja na podlagi nespremenjenih meril zbirata in obravnavata dokaze, potrebne za opravljanje njunih nalog.