en	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.
sl	Upravni odbor na predlog izvršnega direktorja sprejme pravila za podrobno organizacijo in časovni načrt postopkov iz odstavkov 5a in 5b tega člena.

en	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.
sl	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.

en	(c) provide a sound basis for understanding risk management decisions;
sl	(c) zagotavljanje trdne podlage za razumevanje odločitev glede obvladovanja tveganja;

en	The notification of commissioned studies creates a minimal burden.
sl	Obveščanje o naročenih študijah pomeni minimalno breme.

en	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.
sl	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.

en	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."
sl	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."

en	(3) commercial information revealing sourcing, market shares or business strategy of the applicant; and,
sl	(3) poslovnih informacij, ki razkrivajo vire, tržne deleže ali poslovno strategijo vlagatelja ter

en	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.
sl	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.

en	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.
sl	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.

en	Please note that inflation adjustments to the figures mentioned in the tables below, need to be considered as from the year 2023 onwards.
sl	Za obdobje od leta 2023 naprej je treba pri številkah iz naslednjih tabel upoštevati inflacijske prilagoditve.

en	(b) results of production batches of the active substance including impurities; and,
sl	(b) rezultatov proizvodnih serij aktivne snovi, vključno z nečistočami; ter

en	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.
sl	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.

en	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.
sl	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.

en	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.
sl	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.

en	Transitional measures
sl	Prehodni ukrepi

en	This principle remains valid, but the concerns on the transparency and independence of industry-generated studies and data should be addressed.
sl	To načelo še vedno velja, vendar pa bi se morali obravnavati pomisleki glede preglednosti in neodvisnosti študij in podatkov, ki jih pripravi industrija.

en	(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.
sl	(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.

en	(2) commercial links between a producer or importer and the applicant or the authorisation holder, where applicable;
sl	(2) trgovinskih povezav med proizvajalcem ali uvoznikom in vlagateljem ali, kjer je primerno, imetnikom odobritve;

en	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.
sl	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.

en	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.
sl	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.

en	Member States were consulted in a meeting of the Expert Group on the General Food Law on 5 March 2018.
sl	Posvetovanje z državami članicami je potekalo 5. marca 2018 na sestanku strokovne skupine o splošni živilski zakonodaji.

en	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.
sl	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".]

en	2) increase reliability, objectivity and independence of studies
sl	2) Povečati zanesljivost, objektivnost in neodvisnost študij

en	This in turn is expected to have a positive impact on the sustainability of the Union risk assessment system.
sl	To naj bi imelo pozitiven učinek na vzdržnost sistema Unije za ocenjevanje tveganja.

en	Human Resources
sl	Človeški viri

en	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.
sl	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.

en	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.
sl	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.

en	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.
sl	Večja preglednost naj bi prispevala h krepitvi ozračja zaupanja potrošnikov, ki je ugodno za spodbujanje inovacij in za mednarodno priznavanje varnosti proizvodov v Uniji.

en	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.
sl	1) Predlog znanstvenikom in državljanom zagotavlja dostop do ključnih informacij, povezanih z varnostjo, ki jih ocenjuje EFSA na začetni stopnji ocene tveganja.

en	The studies commissioned may have a wider scope than the evidence subject to verification.
sl	Naročene študije so lahko obširnejše kot dokaz, ki se preverja.

en	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,
sl	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

en	(a) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and,
sl	(a) informacij o zaporedju DNK, razen zaporedjih, ki se uporabljajo za odkrivanje, identifikacijo in količinsko določanje transformacijskega dogodka, ter

en	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.
sl	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.

en	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.
sl	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.

en	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).
sl	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).

en	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.
sl	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.

en	In that respect, the proposal sets outs which type of information is to be considered confidential.
sl	V zvezi s tem ta predlog določa, katere vrste informacij je treba obravnavati kot zaupne.

en	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.
sl	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.

en	(b) information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable health effects.
sl	(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.

en	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).
sl	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).

en	Transparency: The proposal aims at strengthening the transparency of the risk assessment process.
sl	Preglednost: S predlogom naj bi se povečala preglednost postopka ocene tveganja.

en	Laboratory related audit can be performed by existing service SANTE.F "Health and Food audits and analysis".
sl	Presoje v zvezi z laboratoriji lahko izvaja obstoječa služba GD SANTE za presoje in analize na področju zdravja in hrane (direktorat F).

en	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.
sl	Sklep začne učinkovati dan po njegovi objavi v Uradnem listu Evropske unije ali na poznejši dan, ki je določen v navedenem sklepu.

en	Divergences between Union and national risk assessors, however, do not necessarily question the work of the different scientific bodies.
sl	Razhajanja med odgovornimi za oceno tveganja na nacionalni ravni in ravni Unije pa nujno ne prinašajo dvomov o delu različnih znanstvenih organov.

en	This is because companies going to laboratories outside the Union would take the risk to be perceived as evading the rules.
sl	Podjetja, ki se odločijo za laboratorije zunaj Unije, bi namreč tvegala, da bi se tako ravnanje lahko razumelo kot izogibanje pravilom.

en	Standard data formats
sl	Standardne oblike zapisa podatkov

en	Moreover, as indicated in the GFL Fitness Check, food and feed safety measures have the greatest effect when taken at Union level.
sl	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.

en	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.
sl	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.

en	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.
sl	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.

en	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.
sl	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.

en	(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.
sl	(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.

en	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.
sl	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.

en	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.
sl	Agencija v svojem poslovniku določi praktično ureditev za izvajanje obveznosti uradnega obveščanja iz odstavkov 1 in 2, vključno s posledicami neizpolnjevanja obveznosti uradnega obveščanja.

en	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.
sl	Vloga se šteje za umaknjeno od trenutka, ko pristojni organ, ki je prejel prvotno vlogo, prejme pisno zahtevo.

en	(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.
sl	(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.

en	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.
sl	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.

en	(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;
sl	(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;

en	Transparency and confidentiality
sl	Preglednost in zaupnost

en	(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.
sl	(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.

en	At the same time, the proposal is expected to ensure the long-term sustainability of EFSA's capacity of scientific expertise.
sl	S predlogom pa naj bi hkrati zagotovili dolgoročno trajnost zmogljivosti agencije EFSA za ohranjanje strokovnega znanja.

en	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.
sl	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.

en	(4) quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion.
sl	(4) kvantitativne sestave predmeta, na katerega se nanaša zaprosilo za znanstveni prispevek, vključno z znanstvenim mnenjem.

en	Recent debates raised concerns on transparency and independence of industry-generated studies and data.
sl	V nedavnih razpravah so bili izraženi pomisleki glede preglednosti in neodvisnosti študij in podatkov industrije.

en	(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.
sl	(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.

en	The EFSA's effectiveness depends on its capacity to attract and pool expertise from Member States.
sl	Učinkovitost agencije EFSA je odvisna od njene zmožnosti, da pritegne in združi strokovno znanje iz držav članic.

en	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.
sl	Agencija že pregleduje znanstveno literaturo, da bi lahko upoštevala druge podatke in študije o predmetu, na katerega se nanaša njena ocena.

en	[19: OJ C , , p.
sl	[19: UL C , , str.

en	(iii) Meeting the needs for the specific multi-disciplinary expertise of the Panel to which they will be appointed and the applicable language regime.
sl	(iii) izpolnjevanje potreb po posebnih večdisciplinarnih strokovnih znanjih znanstvenega sveta, v katerega bodo imenovani, in potreb veljavne jezikovne ureditve.

en	(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;
sl	(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;

en	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.
sl	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.

en	(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.
sl	(13) Pri preverjanju ustreznosti splošne živilske zakonodaje so bile ugotovljene nekatere pomanjkljivosti pri dolgoročni zmogljivosti Agencije za ohranjanje strokovnega znanja na visoki ravni.

en	The GFL Fitness Check and recent public debates have shown that certain aspects of the current legislative framework need to be addressed.
sl	Pri preverjanju ustreznosti splošne živilske zakonodaje in v nedavnih javnih razpravah se je pokazalo, da je treba obravnavati nekatere vidike sedanjega zakonodajnega okvira.

en	(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.
sl	(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.

en	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.
sl	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.

en	Those arrangements shall however be in accordance with the present Regulation and other Union sectoral food law.
sl	Navedena ureditev je v skladu s to uredbo in drugo sektorsko živilsko zakonodajo Unije.

en	EFSA has in place and strictly monitors its rules on "independence" and "conflict of interest"; Control method(s) envisaged
sl	EFSA ima vzpostavljena pravila o „neodvisnosti" in „nasprotju interesov", ki jih pozorno spremlja; načrtovani načini kontrole

en	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.
sl	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.

en	(7) the following Articles 39a to 39g are inserted:
sl	(7) vstavijo se naslednji členi 39a do 39g:

en	Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.
sl	Navedite, kakšne posledice naj bi imel(-a) predlog/pobuda za upravičence/ciljne skupine.

en	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.
sl	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.

en	The term of office of the members referred to in paragraph 1a(c) may be renewable only once.
sl	Mandat članov iz odstavka 1a(c) se lahko samo enkrat podaljša.

en	(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.
sl	(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.

en	[20: OJ C , , p.
sl	[20: UL C , , str.

en	(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.
sl	(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.

en	With respect to requests for scientific outputs, including scientific opinions under Union food law, the Authority shall always make public:
sl	V zvezi z zaprosili za znanstvene prispevke, med drugim tudi za znanstvena mnenja na podlagi živilske zakonodaje Unije, agencija vedno objavi:

en	The consultation on submitted studies does not create additional burdens since the obligation to submit studies to EFSA, Commission and Member States already exists.
sl	Posvetovanje o predloženih študijah ne bo povzročilo dodatnega bremena, saj že obstaja obveznost predložitve študij agenciji EFSA, Komisiji in državam članicam.

en	(a) identify the key factors that need to be taken into account when considering the type and level of risk communications' activities needed;
sl	(a) opredeljeni ključni dejavniki, ki jih je treba upoštevati pri določanju vrste in ravni potrebnih dejavnosti obveščanja o tveganju;

en	Regulation (EC) No 178/2002 on general food law (the "GFL" Regulation) provides for a comprehensive harmonised legal framework.
sl	Uredba (ES) št. 178/2002 o splošni živilski zakonodaji („uredba o splošni živilski zakonodaji") določa celovit in usklajen pravni okvir.

en	Alternatives considered:
sl	Obravnavane alternativne možnosti:

en	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.
sl	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.

en	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.
sl	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.

en	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.
sl	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.

en	(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.
sl	(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.

en	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").
sl	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").

en	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.
sl	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.

en	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.
sl	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.

en	The Executive Director shall inform the Management Board of the requests sent to the Member States.
sl	Izvršni direktor obvesti upravni odbor o zaprosilih, poslanih državam članicam.

en	XX 01 04 yy[50: Sub-ceiling for external staff covered by operational appropriations (former ‘BA' lines).]
sl	XX 01 04 yy[50: Dodatna zgornja meja za zunanje sodelavce v okviru odobritev za poslovanje (prej vrstice BA).]

en	Function group and grade Year
sl	Funkcionalna skupina in razred Leto

en	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.
sl	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.

en	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.
sl	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.

en	The list of information referred to in paragraph 2 shall be without prejudice to any specific Union food law.
sl	Seznam informacij iz odstavka 2 ne posega v nobeno posebno živilsko zakonodajo Unije.

en	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.
sl	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.

en	Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, and 168(4)(b) thereof,
sl	ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti člena 43, člena 114 in člena 168(4)(b) Pogodbe,

en	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.
sl	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.

en	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.
sl	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.

en	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.
sl	osebam, pooblaščenim za izvajanje določenih ukrepov SZVP v skladu z naslovom V PEU in opredeljenim v zadevnem temeljnem aktu.

en	Amendments to Regulation (EC) No 178/2002
sl	Spremembe Uredbe (ES) št. 178/2002

en	(c) The Authority shall make the standard data formats and software packages, as adopted, available on its website.
sl	(c) Agencija da standardne oblike zapisa podatkov in pakete programske opreme, kot so bili sprejeti, na voljo na svojem spletišču.

en	(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.
sl	(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.

en	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.
sl	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.

en	(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;
sl	(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;

en	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.
sl	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.

en	The Executive Director shall notify the Member States of the Authority's independence policy and implementing rules applicable to Scientific Panels' members.
sl	Izvršni direktor obvesti države članice o politiki neodvisnosti agencije in izvedbenih pravilih, ki se uporabljajo za člane znanstvenih svetov.

en	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.
sl	Zato je potrebno in primerno, da nosilci dejavnosti, ki naročijo študije, in laboratoriji, ki te študije izvajajo, študije ob naročilu priglasijo Agenciji.

en	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.
sl	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.

en	Amendments to Directive (EC) 2001/18/EC on the deliberate release into the environment of genetically modified organisms
sl	Spremembe Direktive 2001/18/ES o namernem sproščanju gensko spremenjenih organizmov v okolje

en	(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').
sl	(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").

en	[24: Communication from the Commission on the ECI "Ban glyphosate and protect people and the environment from toxic pesticides", C(2017) 8414 final.]
sl	[24: Sporočilo Komisije o evropski državljanski pobudi „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi", C(2017) 8414 final.]

en	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.
sl	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.

en	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.
sl	Neodvisnost agencije EFSA ne bo v nobenem smislu ogrožena, saj je svetovanje agencije EFSA omejeno na zadevne določbe in na zahtevano vsebino zadevne vloge.

en	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.
sl	Z odstopanjem od člena 38 agencija ne objavi informacij, za katere se zahteva zaupna obravnava pod pogoji iz tega členu.

en	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.
sl	Poleg tega se javna sredstva ne bi smela uporabljati za naročanje dragih študij, ki bodo na koncu industriji pomagale dati izdelek na trg.

en	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.
sl	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.

en	The proposal will not impinge on any intellectual property right which may exist over documents or their content, nor on any regulatory protection set out in Union sectoral legislation covering the agri-food chain rewarding investments (the so-called "data exclusivity rules").
sl	Predlog ne bo posegal v nobeno pravico intelektualne lastnine, ki lahko obstaja na dokumentih ali njihovi vsebini, niti v nobeno regulativno zaščito za spodbujanje naložb, ki je določena v sektorski zakonodaji Unije na področju agroživilske verige (t. i. „pravila o izključnosti podatkov").

en	The members of the Scientific Panels shall be appointed by the Management Board for a renewable five year term of office in accordance with the following procedure:
sl	Člane znanstvenih svetov imenuje upravni odbor za petletni mandat z možnostjo podaljšanja v skladu z naslednjim postopkom:

en	Impact assessment
sl	Ocena učinka

en	Member States shall ensure that the members of the Scientific Panels have the means to dedicate the necessary time and effort to contribute to the work of the Authority.
sl	Države članice zagotovijo, da lahko člani znanstvenih svetov posvetijo dovolj časa in truda delu agencije.

en	Further measures should also be put in place to ensure that scientific experts have the means to act independently.
sl	Vzpostaviti bi bilo treba tudi dodatne ukrepe, ki bodo omogočili neodvisno delovanje znanstvenih strokovnjakov.

en	For the purposes of Article 38(1)(c) and in order to ensure the efficient processing of requests to the Authority for a scientific output, standard data formats and software packages shall be adopted to allow documents to be submitted, searched, copied and printed, while ensuring compliance with regulatory requirements set out in Union food law.
sl	Za namene člena 38(1)(c) in za učinkovito obravnavo zaprosil agenciji za znanstveni prispevek se sprejmejo standardne oblike zapisa podatkov in paketi programske opreme, da se omogoči predložitev, kopiranje in tiskanje dokumentov ter iskanje po njih, hkrati pa zagotavlja skladnost z regulativnimi zahtevami iz živilske zakonodaje Unije.

en	(40) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council and delivered an opinion on […],
sl	(40) V skladu s členom 28(2) Uredbe (ES) št. 45/2001 Evropskega parlamenta in Sveta je bilo opravljeno posvetovanje z Evropskim nadzornikom za varstvo podatkov, ki je podal mnenje […] -

en	The possibility to ask the EFSA to exceptionally commission studies: This is an additional tool where scientific evidence upon which EFSA relies needs to be verified.
sl	Možnost, da se EFSA zaprosi, da izjemoma naroči študije: To je dodatno orodje, ki se lahko uporabi, kadar je treba preveriti znanstvene dokaze, na katere se EFSA opira.

en	The risk of duplicating with activities Member States carry out under OECD agreements is addressed since the Commission auditing programme will be complementary to and coordinated with OECD Good Laboratory Practices (GLP) auditing programmes, which currently audit each Member State monitoring authority every 10 years.
sl	Nevarnost, da bi prišlo do podvajanja z dejavnostmi, ki jih države članice izvajajo na podlagi sporazumov OECD, bo Komisija preprečila tako, da se bo njen program presoj dopolnjeval in usklajeval s programi OECD za presojo dobre laboratorijske prakse, v okviru katerih po sedanji ureditvi vsakih 10 let potekajo presoje nadzornega organa vsake države članice.

en	Members of the Management Board, the Executive Director, members of the Scientific Committee and Scientific Panels as well as external experts participating in their working groups, members of the Advisory Forum and members of the staff of the Authority, even after their duties have ceased, shall be subject to the requirements of confidentiality pursuant to Article 339 of the Treaty.
sl	Za člane upravnega odbora, izvršnega direktorja, člane znanstvenega odbora in znanstvenih svetov kakor tudi zunanje strokovnjake, ki sodelujejo v njihovih delovnih skupinah, člane posvetovalnega foruma in osebje agencije tudi po prenehanju opravljanja njihovih dolžnosti veljajo zahteve glede varovanja poslovnih skrivnosti v skladu s členom 339 Pogodbe.

en	The process to be followed for the processing of confidentiality claims is also set up.
sl	Prav tako je določen postopek za obravnavo zahtev za zaupnost.

en	EFSA Single Programming Document (SPD), EFSA Management Board meeting (responsible for Authority's governance), EFSA Annual report activities.
sl	Enotni programski dokument agencije EFSA, seja upravnega odbora agencije EFSA (odgovornega za upravljanje agencije EFSA), dejavnosti, povezane z letnim poročilom agencije EFSA.

en	As explained in the Explanatory Memorandum of the latter proposal, the Commission did not include in its horizontal alignment legislative proposal, amongst others, Regulation (EC) No 1935/2004, Regulation (EC) No 1331/2008 and Regulation (EC) No 1107/2009, as it is reflecting on whether there is a more appropriate way to structure these acts as concerns individual authorisations/setting of values/listing of specific substances based on the specific criteria set out in those acts, bearing in mind the improved approach adopted by the co-legislators in the context of Regulation (EU) 2015/2283 and the ongoing REFIT reviews of Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009.
sl	Kot je pojasnjeno v obrazložitvenem memorandumu tega predloga, Komisija v svoj zakonodajni predlog za horizontalno uskladitev med drugim ni vključila Uredbe (ES) št. 1935/2004, Uredbe (ES) št. 1331/2008 in Uredbe (ES) št. 1107/2009, saj želi preučiti, ali obstaja primernejše strukturiranje teh aktov v zvezi s posameznimi odobritvami / določitvami vrednosti / naštevanjem posameznih snovi na podlagi posebnih meril, določenih v navedenih aktih, ob upoštevanju izboljšanega pristopa, ki sta ga sozakonodajalca sprejela v Uredbi (EU) 2015/2283 in v tekočem pregledu Uredbe (ES) št. 1935/2004 in Uredbe (ES) št. 1107/2009 v okviru programa REFIT.

en	Notwithstanding paragraph 1, disclosure of names and addresses of natural persons involved in testing on vertebrate animals or in obtaining toxicological information shall be deemed to significantly harm the privacy and the integrity of those natural persons and shall not be made publicly available, unless there is an overriding public interest.
sl	Ne glede na odstavek 1 velja, da bi razkritje imen in naslovov fizičnih oseb, ki sodelujejo pri poskusih na vretenčarjih ali pridobivanju toksikoloških informacij, znatno ogrozilo zasebnost in integriteto navedenih fizičnih oseb, zato se navedeni podatki ne objavijo, razen če prevlada javni interes.

en	To this end, the proposal sets out a cross-sectoral list of information items whose disclosure might be considered to significantly harm the commercial interests at stake and should therefore not be disclosed to the public.
sl	V ta namen predlog določa medsektorski seznam informacij, katerih razkritje bi lahko znatno škodovalo zadevnim poslovnim interesom, zato se ne bi smele razkriti javnosti.

en	Consistency with existing policy provisions in the policy area
sl	Skladnost z veljavnimi predpisi s področja zadevne politike

en	The Commission shall without delay inform the Member States and forward the application to the European Food Safety Authority (hereinafter referred to as the Authority).
sl	Komisija takoj obvesti države članice in posreduje zahtevek Evropski agenciji za varnost hrane (v nadaljnjem besedilu: urad).

en	The members of the Scientific Committee who are not members of Scientific Panels and the additional members referred to in paragraph 5b shall be appointed by the Management Board, acting upon a proposal from the Executive Director, for a five year term of office, which may be renewable, following publication in the Official Journal of the European Union, in relevant leading scientific publications and on the Authority's website of a call for expressions of interest.
sl	Člane znanstvenega odbora, ki niso člani znanstvenih svetov, in dodatne člane iz odstavka 5b imenuje upravni odbor na predlog izvršnega direktorja za petletni mandat z možnostjo podaljšanja po objavi razpisa za prijavo interesa v Uradnem listu Evropske unije, v ustreznih vodilnih znanstvenih publikacijah in na spletišču agencije.

en	Targeted changes are proposed to align the composition of the Management Board of EFSA and the procedure for the external evaluation of EFSA to the Common Approach set out in the annex to the 2012 inter-institutional joint statement on Union decentralised agencies.
sl	Predlagane so ciljne spremembe, da bi se sestava upravnega odbora agencije EFSA in postopek zunanjega ocenjevanja agencije EFSA uskladila s skupnim pristopom, določenim v prilogi k medinstitucionalni skupni izjavi o decentraliziranih agencijah Unije iz leta 2012.

en	The members and alternate members thus nominated shall be appointed by the Council and have voting rights.
sl	Tako predlagane člane in nadomestne člane imenuje Svet in imajo glasovalno pravico.

en	(b) The following paragraphs 5a to 5g are inserted:
sl	(b) vstavijo se naslednji odstavki 5a do 5g:

en	The relevant items shall be available to download, print and search through in an electronic format.
sl	Zadevni dokumenti so v elektronski obliki na voljo za prenos, tisk in iskanje.

en	At the request of a potential applicant for a food law authorisation, the staff of the Authority shall advise on the relevant provisions and the required content of the application for authorisation.
sl	Na zahtevo morebitnega vlagatelja vloge za odobritev na podlagi živilske zakonodaje osebje agencije svetuje o zadevnih določbah in potrebni vsebini vloge za odobritev.

en	For the adoption of standard data formats and software packages the following procedure shall be followed:
sl	Standardne oblike zapisa podatkov in paketi programske opreme se sprejmejo po naslednjem postopku:

en	It will help applicants in particular small and medium sized enterprises in understanding how to prepare authorisation applications.
sl	Vložniki, zlasti mala in srednja podjetja, bodo lažje razumela, kako je treba pripraviti vloge za odobritev.

en	(2) Regulation (EC) No 178/2002 defines "risk analysis" as a process consisting of three interconnected components: risk assessment, risk management and risk communication.
sl	(2) Uredba (ES) št. 178/2002 opredeljuje „analizo tveganja" kot postopek, sestavljen iz treh med seboj povezanih sestavnih delov: ocene tveganja, obvladovanja tveganja in obveščanja o tveganju.

en	develop a comprehensive and effective risk communication strategy, involving the Commission, Member States and the EFSA throughout the risk analysis process, combined with open dialogue amongst all interested parties.
sl	razvoja celovite in učinkovite strategije za obveščanje o tveganju, ki vključuje Komisijo, države članice in agencijo EFSA v celotnem postopku analize tveganja, skupaj z odprtim dialogom med vsemi zainteresiranimi stranmi.

en	(e) the annual declarations of interest made by members of the Management Board, the Executive Director, members of the Advisory Forum and members of the Scientific Committee, Scientific Panels and of their Working Groups, as well as the declarations of interest made in relation to items on the agendas of meetings;
sl	(e) letne izjave o interesih, ki jih podajo člani upravnega odbora, izvršni direktor, člani posvetovalnega foruma ter člani znanstvenega odbora, znanstvenih svetov in njihovih delovnih skupin, pa tudi izjave o interesih glede točk dnevnih redov zasedanj;

en	The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication.
sl	V splošnem načrtu bi morali biti opredeljeni tudi orodja in kanali, ki jih je treba uporabiti, ter vzpostavljeni ustrezni mehanizmi za zagotovitev usklajenega obveščanja o tveganju.

en	The potential impact of revealing the business strategy of a company by the notification of commissioned studies on a new substance has been neutralised since this information is made public only when the studies included in the corresponding authorisation application are made public so at a time where such a publication cannot have the effect to reveal a business strategy.
sl	Morebitni učinek, da bi se pri obveščanju o naročenih študijah o novi snovi razkrila poslovna strategija podjetja, je izničen, saj se te informacije javno objavijo le po objavi študij, ki so bile vključene v ustrezno vlogo za odobritev, torej v trenutku, ko taka objava ne more povzročiti razkritja poslovne strategije.

en	The risk analysis principle consists of three separate but interconnected components: risk assessment, risk management and risk communication.
sl	Načelo analize tveganja je sestavljeno iz treh ločenih, a medsebojno povezanih sestavnih delov: ocene tveganja, obvladovanja tveganja in obveščanja o tveganju.

en	The disclosure to the public of the information mentioned in paragraph (1)(c) shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be used, reproduced, or otherwise exploited and its use by third parties shall not engage the responsibility of the European Union."
sl	Javno razkritje informacij iz odstavka (1)(c) se ne šteje za eksplicitno ali implicitno dovoljenje ali licenco za uporabo, razmnoževanje ali drugačno izkoriščanje zadevnih podatkov in informacij ter njihove vsebine, za njihovo uporabo s strani tretjih oseb pa ni odgovorna Evropska unija.

en	Estimated impact on the staff (additional FTE) - establishment plan
sl	Ocenjene posledice za osebje (dodatni EPDČ) - kadrovski načrt

en	In order to provide an additional level of guarantee ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available.
sl	Da se zagotovi dodatna raven jamstva, ki omogoča dostop Agencije do vseh ustreznih znanstvenih podatkov in študij o predmetu postopka odobritve, je primerno predvideti posvetovanje s tretjimi osebami, da se ugotovi, ali so na voljo drugi relevantni znanstveni podatki ali študije.

en	The confidential version shall contain all information submitted, including information the applicant deems confidential.
sl	Zaupna različica vsebuje vse predložene informacije, vključno z informacijami, ki jih vlagatelj šteje za zaupne.

en	[1) improve and clarify the rules on transparency, especially with regard to the scientific studies supporting the risk assessment;
sl	[1) izboljšati in pojasniti pravila o preglednosti, zlasti glede znanstvenih študij v podporo oceni tveganja;

en	(e) make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks after the notification of its decision to the applicant has taken place, pursuant to point (d).
sl	(e) objavi vse dodatne podatke in informacije, v zvezi s katerimi zahteva za zaupnost ni bila odobrena kot upravičena, ne prej kot v dveh tednih po tem, ko vlagatelja v skladu s točko (d) uradno obvesti o svoji odločitvi.

en	It ensures that action can be taken at Union level where there are exceptional circumstances of serious controversies or conflicting results.
sl	Zagotavlja, da je mogoče ukrep v izrednih okoliščinah - če gre za sporna vprašanja ali nasprotujoče si rezultate - sprejeti na ravni Unije.

en	Regulatory fitness and simplification
sl	Ustreznost in poenostavitev ureditve

en	The transparency provisions are without prejudice to any existing Intellectual Property Rights and data exclusivity provisions set out in Union sectoral food legislation.
sl	Določbe o preglednosti ne posegajo v obstoječe pravice intelektualne lastnine in določbe o izključnosti podatkov iz sektorske živilske zakonodaje Unije.

en	However, this process should be without prejudice to existing intellectual property rights or to any provisions of Union food law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations.
sl	Vendar ta postopek ne bi smel posegati v obstoječe pravice intelektualne lastnine ali katero koli določbo iz živilske zakonodaje Unije, ki ščiti naložbe inovatorjev pri zbiranju informacij in podatkov v podporo zadevnim vlogam za odobritev.

en	Member States appreciate that the challenges in relation to food safety, in an environment with very high levels of trade and a complex food supply chain, require a strong Union regulatory system.
sl	Države članice se zavedajo, da je za reševanje izzivov v zvezi z varnostjo hrane v okolju z zelo visokim deležem trgovine in kompleksno verigo preskrbe s hrano potreben trden regulativen sistem Unije.

en	Amendments to Regulation (EU) No 2015/2283 on novel foods
sl	Spremembe Uredbe (EU) 2015/2283 o novih živilih

en	EFSA provides the advice in a transparent way since it makes it public.
sl	Svetovanje agencije EFSA je pregledno, saj je na voljo javnosti.

en	(d) adopt a reasoned decision on the confidentiality request taking into account the observations of the applicant within ten weeks from the date of receipt of the confidentiality request with respect to applications for authorisation and without undue delay in the case of supplementary data and information and notify the applicant and inform the Commission and the Member States, as appropriate, of its decision; and,
sl	(d) ob upoštevanju pripomb vlagatelja sprejme utemeljeno odločitev o zahtevi za zaupnost v desetih tednih od datuma prejema zahteve za zaupnost v zvezi z vlogami za odobritev, v primeru dodatnih podatkov in informacij pa brez nepotrebnega odlašanja ter o svoji odločitvi uradno obvesti vlagatelja, po potrebi pa jo sporoči tudi Komisiji in državam članicam; ter

en	The consultation on submitted studies will identify other available relevant scientific data or studies on a substance subject to authorisation thus strengthening EFSA's evidence base and diminishing its reliance on only industry studies.
sl	V posvetovanjih o predloženih študijah bodo opredeljeni drugi ustrezni razpoložljivi znanstveni podatki ali študije o snovi, ki je predmet odobritve, kar bo okrepilo dokazno podlago agencije EFSA in zmanjšalo njeno odvisnost samo od študij industrije.

en	Officials (AST grades)
sl	Uradniki (razredi AST)

en	The second measure sets out a pre-submission procedure, by which EFSA can provide advice to an applicant (without entering into the design of the study) and this advice will be made public.
sl	Drugi ukrep določa postopek pred vložitvijo vloge, s katerim EFSA lahko svetuje vlagatelju (ne da bi pri tem obravnavala zasnovo študije), pri čemer se njen nasvet objavi.

en	Seconded National Experts
sl	Napoteni nacionalni strokovnjaki

en	(28) Accordingly and with respect to the procedures governing requests for authorisation procedures provided in Union food law, experience gained so far has shown that certain information items are generally considered sensitive and should remain confidential across the different sectoral authorisation procedures.
sl	(28) V skladu s tem in ob upoštevanju postopkov, ki veljajo za vloge za odobritev na podlagi živilske zakonodaje Unije, so dosedanje izkušnje pokazale, da se nekatere informacije običajno obravnavajo kot občutljive in bi morale ostati zaupne v različnih sektorskih postopkih odobritve.

en	An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State, (the rapporteur Member State), together with a summary and a complete dossier as provided for in Article 8(1) and (2) of this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4 of this Regulation.
sl	Proizvajalec aktivne snovi predloži državi članici (država članica poročevalka) zahtevek za odobritev aktivne snovi ali za spremembo pogojev za odobritev skupaj s povzetkom in popolno dokumentacijo, kakor je določeno v členu 8(1) in (2) te uredbe, ali na podlagi znanstvene obrazložitve utemelji, zakaj nekaterih delov te dokumentacije ne more predložiti, ter dokaže, da aktivna snov izpolnjuje merila za odobritev iz člena 4 te uredbe.

en	(i) advice provided by the Authority to potential applicants at pre-submission phase pursuant to Article 32a and 32c.
sl	(i) mnenje, ki ga agencija predloži morebitnim vlagateljem pred vložitvijo vloge v skladu s členoma 32a in 32c.

en	Upon a request for access to information and after consultation with the Authority, the rapporteur Member States shall decide what information is to be kept confidential, in accordance with Article 63.
sl	Ob predložitvi zahteve za dostop do informacij in po posvetovanju z Agencijo se država članica poročevalka odloči, katere informacije bo v skladu s členom 63 obravnavala zaupno.

en	(b) identify the appropriate main tools and channels to be used for risk communication purposes, taking into account the needs of relevant target audience groups; and,
sl	(b) opredeljena ustrezna glavna orodja in kanali, ki jih je treba uporabiti pri obveščanju o tveganju, pri čemer se upoštevajo potrebe zadevnih ciljnih skupin; ter

en	Furthermore, scientific divergences related to food and feed safety are particularly high on the public agenda, whether these are real or perceived, especially where other societal choices are at stake, such as the protection of the environment or consumers' right to choose the type of foods which they eat.
sl	Poleg tega se o znanstvenih razhajanjih - bodisi dejanskih bodisi domnevnih -, povezanih z varnostjo živil in krme, posebno veliko javno razpravlja, zlasti kadar gre pri tem tudi za druge družbene izbire, kot sta varstvo okolja ali pravica potrošnikov do proste izbire živil.

en	YES NO NO NO
sl	NE DA/NE

en	In particular, the systematic implementation of the risk analysis principle at Union level has raised the overall level of protection of human health across the Union and minimised differences in approach between Member States to key food safety risks.
sl	Z doslednim izvajanjem načela analize tveganja na ravni Unije se je zlasti povečala splošna raven varovanja zdravja ljudi po vsej Uniji in kar najbolj zmanjšale razlike v pristopu h ključnim tveganjem v zvezi z varnostjo hrane med državami članicami.

en	In particular, the increased level of transparency and accountability of the studies EFSA uses to assess risks could not be achieved without opening up those studies and the data they use to public scrutiny.
sl	Zlasti pa ne bi bilo mogoče doseči povečane ravni preglednosti in odgovornosti študij, na podlagi katerih EFSA oceni tveganja, ne da bi omogočili dostop do teh študij in podatkov, na katerih temeljijo, ter jih tako izpostavili javnemu nadzoru.

en	The Commission experts shall perform controls, including audits, to obtain assurance that testing facilities comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law.
sl	Strokovnjaki Komisije izvajajo nadzor, vključno s presojami, da se prepričajo, da preizkuševalne zmogljivosti izpolnjujejo ustrezne standarde za izvajanje preizkusov in študij, predloženih agenciji v okviru vloge za odobritev na podlagi živilske zakonodaje Unije.

en	The main identified costs fall on EFSA, since it will have the main responsibility of taking a decision, within tight deadlines to avoid making the authorisation procedures longer, on all confidentiality claims made by applicants in the context of authorisation procedures, in cases in which an opinion of EFSA is to be provided.
sl	Največji delež opredeljenih stroškov bo krila EFSA, saj bo predvsem sama odgovorna za sprejemanje odločitev v zelo kratkih rokih, da se odobritveni postopki ne bi podaljšali, glede vseh zahtev za zaupnost, ki jih vložijo vlagatelji v okviru odobritvenih postopkov, v primerih, ko je potrebno mnenje agencije EFSA.

en	Amendments to Regulation (EC) No 1107/2009 on plant protection products
sl	Spremembe Uredbe (ES) št. 1107/2009 o fitofarmacevtskih sredstvih

en	(c) establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers and ensure an open dialogue amongst all interested parties.
sl	(c) vzpostavljeni ustrezni mehanizmi, s katerimi se bo povečala usklajenost obveščanja o tveganju med odgovornimi za oceno tveganja in odgovornimi za obvladovanje tveganja ter zagotovil odprt dialog med vsemi zainteresiranimi stranmi.

en	(a) the specification of impurity of the active substance and the related methods of analysis for impurities in the active substance as manufactured, except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant and the related methods of analysis for these impurities;
sl	(a) specifikacij nečistosti aktivne snovi in povezanih metod analize nečistoč v aktivni snovi, kakor je proizvedena, razen nečistoč, ki se štejejo za toksikološko, ekotoksikološko ali okoljsko relevantne, ter zadevnih metod analize teh nečistoč;

en	The GFL Fitness Check has clearly shown that a high level of protection of public health and consumers' interests across the Union in the area of food is best achieved through Union action.
sl	Pri preverjanju ustreznosti splošne živilske zakonodaje se je jasno pokazalo, da je visoko raven varovanja javnega zdravja in interesov potrošnikov po vsej Uniji na področju hrane najbolje doseči z ukrepi na ravni Unije.

en	This should give EFSA greater legitimacy in the eyes of consumers and the general public, increasing their confidence in its work.
sl	Tako naj bi se povečala legitimnost agencije EFSA v očeh potrošnikov in splošne javnosti ter s tem tudi njihovo zaupanje v njeno delo.

en	Following this notification, the Authority shall launch a consultation of stakeholders and the public on the intended studies for renewal and shall provide advice on the content of the intended renewal application taking into account the received comments.
sl	Po tem obvestilu začne agencija posvetovanje z zainteresiranimi stranmi in javnostjo glede predvidenih študij za namen obnovitve ter predloži mnenje o vsebini predvidene vloge za obnovitev, pri čemer upošteva prejete pripombe.

en	The third measure provides that at the stage of submission of authorisation application, when all studies are made public according to the new provisions on transparency, a consultation of third parties will be launched with the aim to identify whether other relevant scientific data or studies are available.
sl	Tretji ukrep določa, da se na stopnji vložitve vloge za odobritev po objavi vseh študij v skladu z novimi določbami o preglednosti izvede posvetovanje s tretjimi osebami, da se ugotovi, ali so na voljo drugi relevantni znanstveni podatki ali študije.

en	(8) The general plan should identify the key factors to be taken into account when risk communications' activities are considered, such as the different levels of risk, the nature of the risk and its potential public health impact, who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context.
sl	(8) V splošnem načrtu bi morali biti opredeljeni ključni dejavniki, ki jih je treba upoštevati pri dejavnostih obveščanja o tveganju, kot so različne ravni tveganja, vrsta tveganja in njegove morebitne posledice za javno zdravje, koga in kaj tveganje neposredno ali posredno prizadene, ravni izpostavljenosti tveganju, zmožnost obvladovanja tveganja in drugi dejavniki, ki vplivajo na dojemanje tveganja, vključno s stopnjo nujnosti, veljavnim zakonodajnim okvirom in razmerami na zadevnem trgu.

en	(29) For the purposes of clarity and to increase legal certainty, it is necessary to set out the specific procedural requirements to be followed in respect of a request for information submitted for the purposes of authorisation procedures under Union food law to be treated in a confidential manner.
sl	(29) Zaradi jasnosti in da se poveča pravna varnost, je treba določiti posebne postopkovne zahteve, ki jih je treba upoštevati v zvezi z zahtevo za zaupno obravnavo informacij, predloženih za namen postopkov odobritve na podlagi živilske zakonodaje Unije.

en	The selection process by the Executive Director involves checking that the experts it proposes are in line with EFSA's policy and rules on independence and it is expected that the Executive Director, given its specific role, will be vigilant on this key issue for EFSA.
sl	Izvršni direktor pri izboru strokovnjakov preveri, ali so ti skladni s politiko in pravili agencije EFSA o neodvisnosti, in pričakuje se, da je izvršni direktor glede na svojo specifično vlogo še zlasti previden pri tem ključnem vprašanju za agencijo EFSA.

en	The GFL Fitness Check, completed on 15 January 2018, concluded that the systematic implementation of the risk analysis principle in Union food law has increased overall protection of public health.
sl	Pri preverjanju ustreznosti splošne živilske zakonodaje, ki se je končalo 15. januarja 2018, je bilo ugotovljeno, da se je z doslednim izvajanjem načela analize tveganja v živilski zakonodaji Unije povečalo splošno varovanje javnega zdravja.

en	(14) To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels by the Member States, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel.
sl	(14) Da bi ocenjevanje tveganja ostalo neodvisno od obvladovanja tveganja in drugih interesov na ravni Unije, je primerno, da predlog članov znanstvenih svetov s strani držav članic, izbor članov, ki ga opravi izvršni direktor Agencije, in njihovo imenovanje, ki ga opravi upravni odbor Agencije, temeljijo na strogih merilih, ki zagotavljajo odličnost in neodvisnost strokovnjakov in hkrati potrebno večdisciplinarno strokovno znanje vsakega sveta.

en	(a) The Executive Director, after consulting the Management Board, shall send to the Member States the request for the specific multidisciplinary expertise needed in each Scientific Panel and shall indicate the number of experts to be nominated by the Member States.
sl	(a) Izvršni direktor po posvetovanju z upravnim odborom pošlje državam članicam zaprosilo za posebna večdisciplinarna strokovna znanja, potrebna v posameznem znanstvenem svetu, ter navede število strokovnjakov, ki jih morajo predlagati države članice.

en	There is no risk of public authorities becoming responsible for providing evidence on the safety of substance for EFSA's assessment, since the principle that it is the responsibility of the industry (applicants) to provide such evidence during the risk assessment process remains.
sl	Ni tveganja, da bi se odgovornost za predložitev dokazov o varnosti snovi za namen njene ocene, ki jo pripravi EFSA, prenesla na javne organe, saj se ohrani načelo, da je industrija (vlagatelji) odgovorna za predložitev takih dokazov v postopku ocenjevanja tveganja.

en	Member States shall launch a call for interest as a basis for their nominations.
sl	Države članice objavijo razpis za prijavo interesa, na podlagi katerega predlagajo svoje kandidate.

en	As for other agencies, EFSA independence is appropriately safeguarded by the criteria for nomination that privilege members with a profile of risk assessor and the strong provisions on independence and on transparency since the rules providing that the members of the Management Board have to act independently in the public interest and make an annual public declaration of interests remain unchanged.
sl	Kot pri drugih agencijah je tudi neodvisnost agencije EFSA ustrezno zaščitena z merili za imenovanje, ki dajejo prednost članom s profilom odgovornega za oceno tveganja, ter s strogimi določbami o neodvisnosti in preglednosti, saj ostajajo pravila, ki določajo, da morajo člani upravnega odbora delovati neodvisno in v javnem interesu ter vsako leto podati javno izjavo o interesih, nespremenjena.

en	(a) any information provided in detailed descriptions of starting substances and preparations used to manufacture the substance subject to the authorisation, the composition of preparations, materials or articles in which the applicant intends to use this substance, the manufacturing methods of these preparations, materials or articles, impurities, and migration testing results;
sl	(a) vseh informacij, predloženih v podrobnih opisih izhodnih snovi in pripravkov, ki se uporabljajo za proizvodnjo snovi, ki je predmet odobritve, sestave pripravkov, materialov ali izdelkov, v katerih vlagatelj namerava uporabiti to snov, metod proizvodnje teh pripravkov, materialov ali izdelkov, nečistoč ter rezultatov migracijskih preskusov;

en	(36) To ensure that sectoral specificities with respect to confidential information are taken into account, it is necessary to weigh up the relevant rights of the public to transparency in the risk assessment process, including those flowing from the Aarhus Convention, against the rights of commercial applicants, taking into account the specific objectives of sectoral Union legislation as well as experienced gained.
sl	(36) Za zagotovitev, da se upoštevajo sektorske posebnosti glede zaupnih informacij, je treba ustrezne pravice javnosti do preglednosti v postopku ocenjevanja tveganja, vključno s tistimi, ki izhajajo iz Aarhuške konvencije, ponderirati glede na pravice poslovnih vlagateljev, ob upoštevanju posebnih ciljev sektorske zakonodaje Unije in pridobljenih izkušenj.

en	To align EFSA Management Board with the Inter-Institutional agreement to include Member States in the Management Board, similarly to other Union agencies and provide for an increased involvement of Member States in the appointment of scientific experts as it is the case in other similar scientific Union agencies.
sl	Uskladitev upravnega odbora agencije EFSA z medinstitucionalnim sporazumom za vključitev držav članic v upravni odbor, podobno kot pri drugih agencijah Unije, ter zagotovitev večje vključenosti držav članic v imenovanje znanstvenih strokovnjakov, kot je značilno za druge podobne znanstvene agencije Unije.

en	Risk communication is defined as the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions amongst risk assessors, risk managers, consumers, feed and food businesses, the academic community, including the explanation of risk assessment findings and the basis of risk management decisions.
sl	Obveščanje o tveganju je opredeljeno kot interaktivna izmenjava informacij in mnenj v postopku analize tveganja glede nevarnosti in tveganj, dejavnikov, povezanih s tveganji, ter dojemanja tveganja med odgovornimi za oceno tveganja, odgovornimi za obvladovanje tveganja, potrošniki, podjetji, ki poslujejo z živili in krmo, akademsko skupnostjo, vključno s razlago ugotovitev iz ocene tveganja in podlage za odločitve o obvladovanju tveganja.

en	As indicated, the measures create small additional burdens for applicants since they are limited to the notifications of commissioned studies in all cases and of planned studies in the case of renewals, given that the submission of studies in authorisation application is already foreseen in existing legislation.
sl	Kot je navedeno, ukrepi povzročajo le majhno dodatno breme za vlagatelje, saj so omejeni na obveščanje o naročenih študijah v vseh primerih in o načrtovanih študijah v primeru obnovitev ter je priložitev študij vlogi za odobritev določena že v obstoječi zakonodaji.

en	Where the withdrawal of the application takes place before the Authority has decided on the relevant confidentiality request, the Authority, the Commission and the Member States shall not make public the information for which confidentiality has been requested.
sl	Kadar vlagatelj umakne vlogo, preden se agencija odloči o zadevni zahtevi za zaupnost, agencija, Komisija in države članice ne objavijo informacij, za katere je bila zahtevana zaupna obravnava.

en	[52: See Articles 11 and 17 of Council Regulation (EU, Euratom) No 1311/2013 laying down the multiannual financial framework for the years 2014-2020.]
sl	[52: Glej člena 11 in 17 Uredbe Sveta (EU, Euratom) št. 1311/2013 o večletnem finančnem okviru za obdobje 2014-2020.]

en	The Authority shall lay down in its internal rules the practical arrangements for implementing the transparency rules referred to in paragraphs 1, 1a and 2 of this Article, taking into account Articles 39 to 39g and Article 41.
sl	Agencija v svojem poslovniku določi praktično ureditev za izvajanje pravil o preglednosti iz odstavkov 1, 1a in 2 tega člena, ob upoštevanju členov 39 do 39g in člena 41.

en	Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health, animal health or the environment, such information should be disclosed.
sl	Take informacije bi moralo biti dovoljeno razkriti samo v zelo omejenih in izjemnih okoliščinah, povezanih s predvidljivimi učinki na zdravje in nujno potrebo po varovanju zdravja ljudi in živali ali okolja.

en	Duration and financial impact
sl	Trajanje ukrepa in finančnih posledic

en	Risk management is defined as the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options.
sl	Obvladovanje tveganja je, za razliko od ocene tveganja, opredeljeno kot postopek presojanja možnosti politike v posvetovanju z zainteresiranimi stranmi, ob upoštevanju ocene tveganja in drugih upravičenih dejavnikov ter po potrebi izbora ustreznih možnosti za preprečevanje in nadzor.

en	The present proposal provides one empowerment for a delegated act in the context of Regulation (EC) No 178/2002, which is in the process of being aligned.
sl	Ta predlog določa eno pooblastilo za delegirani akt v okviru Uredbe (ES) št. 178/2002, ki je v postopku usklajevanja.

en	The Authority shall lay down in its internal rules the practical arrangement for implementing the procedures referred to in Articles 32a and this Article.
sl	Agencija v svojem poslovniku določi praktično ureditev za izvajanje postopkov iz člena 32a in tega člena.

en	Confidentiality
sl	Zaupnost

en	The GFL Fitness Check has also highlighted the need to establish a more comprehensive monitoring system of the implementation of Union food law, so as to provide policy makers and the public with more solid data and evidence base to regularly assess the relevant impacts.
sl	Pri preverjanju ustreznosti splošne živilske zakonodaje je bila prav tako izpostavljena potreba po vzpostavitvi bolj celovitega sistema za spremljanje izvajanja živilske zakonodaje Unije, da bi oblikovalcem politik in javnosti dali na voljo bolj zanesljive podatke in dokaze za redno oceno zadevnih učinkov.

en	Where Union food law provides that an authorisation may be renewed, the potential applicant for the renewal shall notify the Authority of the studies it intends to perform for that purpose.
sl	Če živilska zakonodaja Unije določa, da se odobritev lahko obnovi, morebitni vlagatelj vloge za obnovitev uradno obvesti agencijo o študijah, ki jih namerava izvesti v ta namen.

en	To address the emerging challenges in the area of food law in light of the experience gained to date (Fitness Check of the GFL Regulation published on 15 January 2018) and the Commission's reply to the ECI.
sl	Obravnava izzivov, ki se pojavljajo na področju živilske zakonodaje, glede na do zdaj pridobljene izkušnje (preverjanje ustreznosti uredbe o splošni živilski zakonodaji, objavljeno 15. januarja 2018) in odgovor Komisije na evropsko državljansko pobudo.

en	With regard to additional controls on the conduct of studies, the two measures proposed (audit/controls by Union inspectors and possibility to commission ad hoc studies in exceptional circumstances with the aim to verify evidence used by EFSA in its risk assessment), will provide additional assurances on the quality and objectivity of the studies used by EFSA for its risk assessment while not impacting on innovation since limited to specific or exceptional cases.
sl	Kar zadeva dodatni nadzor nad izvajanjem študij, se bodo z obema predlaganima ukrepoma (presoja/nadzor, ki jo/ga izvajajo inšpektorji Unije, in možnost naročanja ad hoc študij v izjemnih okoliščinah, da se preverijo dokazi, ki jih je EFSA uporabila v svoji oceni tveganja) zagotovila dodatna jamstva za kakovost in objektivnost študij, ki jih je EFSA uporabila v svoji oceni tveganja, ne da bi to zaviralo inovacije, saj sta omejena na posebne in izjemne primere.

en	Where the Commission requests an opinion from, the European Food Safety Authority (‘the Authority'), the Authority shall ensure public access to the application in accordance with Article 23 and shall give its opinion as to whether the update is liable to have an effect on human health.
sl	Kadar Komisija zahteva mnenje Evropske agencije za varnost hrane (v nadaljnjem besedilu: Agencija), Agencija v skladu s členom 23 zagotovi javni dostop do vloge in poda mnenje, ali bi lahko posodobitev vplivala na zdravje ljudi.

en	Compliance costs for businesses will not increase because existing rules already require applications including studies to be submitted to the relevant regulatory authority, e.g. the Commission, EFSA and the Member States, followed by confidentiality claims.
sl	Stroški izpolnjevanja obveznosti za podjetja se ne bodo povečali, saj obstoječa pravila že zahtevajo vložitev vlog pri zadevnem regulativnem organu, na primer Komisiji, agenciji EFSA in državah članicah, ki vključujejo študije in zadevne zahteve za zaupnost.

en	According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter.
sl	V skladu s tem načelom in veljavnimi regulativnimi zahtevami morajo vlagatelji v podporo vlogam za odobritev na podlagi sektorske živilske zakonodaje Unije predložiti ustrezne študije, vključno s preizkusi, da se dokažeta varnost in v nekaterih primerih učinkovitost predmeta.

en	Governance and greater Member State involvement in the Management Board: The proposal will align EFSA's governance with the model used for other Union agencies in line with the inter-institutional Common Approach on Union decentralised agencies, thus increasing the global consistency of the Union agencies' Management Board model.
sl	Upravljanje in večja vključenost držav članic v upravnem odboru: Predlog bo upravljanje agencije EFSA prilagodil modelu, ki se uporablja za druge agencije Unije, v skladu z medinstitucionalnim skupnim pristopom k decentraliziranim agencijam Unije, s čimer se bo povečala globalna usklajenost modela upravnega odbora agencij Unije.

en	under HEADING 5
sl	RAZDELKA 5

en	(a) promote awareness and understanding of the specific issues under consideration during the entire risk analysis process;
sl	(a) spodbujanje ozaveščenosti o posebnih vprašanjih, obravnavanih v celotnem postopku analize tveganja, in njihovega razumevanja;

en	While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment.
sl	Poleg ohranjanja načela, da breme za dokazovanje skladnosti z zahtevami Unije nosi industrija, je pomembno vzpostaviti dodatno orodje za preverjanje za obravnavo posebnih primerov, ki so za družbo zelo pomembni in povzročajo polemiko glede varnosti, tj. naročanje dodatnih študij za preverjanje dokazov, uporabljenih v postopku ocenjevanja tveganja.

en	(23) The Fitness Check of the General Food Law demonstrated that although the Authority has made considerable progress in terms of transparency, the risk assessment process, especially in the context of authorisation procedures covering the agri-food chain, is not always perceived as fully transparent.
sl	(23) Pri preverjanju ustreznosti splošne živilske zakonodaje se je pokazalo, da se postopek ocenjevanja tveganja, zlasti glede postopkov odobritve za agroživilsko verigo, kljub precejšnjemu napredku Agencije v smislu preglednosti, ne dojema vedno kot popolnoma pregleden.

en	(b) one member appointed by the European Parliament, with the right to vote.
sl	(b) en član z glasovalno pravico, ki ga imenuje Evropski parlament;

en	under HEADINGS 1 to 5
sl	RAZDELKOV od 1 do 5

en	However, given the limits of its competence, EFSA's risk communication activities cannot address questions on issues other than science, notably the risk management decisions informed by its scientific advice.
sl	Zaradi njenih omejenih pristojnosti pa lahko dejavnosti agencije EFSA na področju obveščanja o tveganju zajemajo le znanstvena vprašanja, zato zlasti ne sme obveščati o odločitvah glede obvladovanja tveganja, sprejetih na podlagi njenega znanstvenega mnenja.

en	In order of multiannual financial framework headings and budget lines.
sl	Po vrstnem redu razdelkov večletnega finančnega okvira in proračunskih vrstic.

en	(31) For the purposes of increased transparency and in order to ensure that requests for scientific outputs received by the Authority are processed in an effective manner, standard data formats and software packages should be developed.
sl	(31) Za namene povečane preglednosti in zagotovitev učinkovite obravnave zaprosil za znanstvene prispevke, ki jih prejme Agencija, bi bilo treba razviti standardne formate podatkov in pakete programske opreme.

en	(a) make public, without delay, the non-confidential version, as submitted by the applicant;
sl	(a) nemudoma objavi nezaupno različico, kot jo je predložil vlagatelj;

en	(a) two members and the alternate members appointed by the Commission and representing the Commission, with the right to vote.
sl	(a) dva člana in nadomestna člana z glasovalno pravico, ki jih imenuje Komisija in predstavljajo Komisijo;

en	Total 8.5 14.9 21.2 21.2 21.2
sl	Skupaj 8,5 14,9 21,2 21,2 21,2

en	Insourcing routine work 15 FTEs 0.775 1.357 1.938
sl	Notranje izvajanje rutinskega dela 15 EPDČ 0,775 1,357 1,938

en	The Commission and the Member States shall take the necessary measures so that information received by them under Union food law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the Authority and has become definitive.
sl	Komisija in države članice sprejmejo potrebne ukrepe, da ne objavijo informacij, ki jih prejmejo na podlagi živilske zakonodaje Unije in za katere se zahteva zaupna obravnava, dokler agencija ne sprejme odločitve o zahtevi za zaupnost in ta ne postane dokončna.

en	Public access to all scientific data and information supporting requests for authorisations under Union food law as well as other requests for scientific output should be ensured, as early as possible in the risk assessment process.
sl	Zagotoviti bi bilo treba javni dostop do vseh znanstvenih podatkov in informacij v podporo vlogam za odobritev na podlagi živilske zakonodaje Unije ter zaprosilom za znanstvene prispevke, in sicer čim bolj zgodaj v postopku ocenjevanja tveganja.

en	The impact on the duration of the authorisation procedures is minimal since this procedure is at the pre-submission stage and it may have a positive impact in reducing the length of authorisation procedures, as concerns may be raised and addressed early on in the process.
sl	Učinek na trajanje odobritvenih postopkov je minimalen, saj poteka obveščanje pred vložitvijo vloge, lahko pa je učinek tudi pozitiven v obliki skrajšanih odobritvenih postopkov, saj se lahko pomisleki izrazijo in obravnavajo že zgodaj v postopku.

en	"(c) the Authority shall without delay:
sl	„(c) Agencija nemudoma:

en	(c) the names of all participants in meetings of the Scientific Committee and the Scientific Panels and their Working Groups.
sl	(c) imena vseh udeležencev zasedanj znanstvenega odbora in znanstvenih svetov ter njihovih delovnih skupin;

en	It is proposed to empower the Commission to draw up this general plan for the purposes of Regulation (EC) No 178/2002 by means of delegated acts.
sl	V predlogu je predlagano, da se Komisija pooblasti, da z delegiranimi akti pripravi ta splošni načrt za namene Uredbe (ES) št. 178/2002.

en	The measures establishing a register of commissioned studies and the measure providing for a consultation on submitted studies will bring benefits by ensuring that EFSA has access to as much evidence as possible on a substance submitted for its assessment.
sl	Ukrepi za vzpostavitev registra naročenih študij in za izvedbo posvetovanja o predloženih študijah bodo prinesli koristi, saj bodo zagotovili, da ima EFSA dostop do čim več dokazov o snovi, predloženi v njeno oceno.

en	This principle is based on the premise that public health is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market.
sl	To načelo temelji na predpostavki, da se javno zdravje bolje varuje, če dokazno breme nosi vlagatelj, ki mora dokazati, da je določen predmet varen, preden se da na trg, namesto da bi javni organi morali dokazati, da predmet ni varen, da bi se lahko prepovedalo njegovo dajanje na trg.

en	The information systems operated by the Authority to store its data, including confidential and personal data shall be designed to a high level of security appropriate to the security risks at stake, taking into account Articles 39 to 39f of this Regulation.
sl	Informacijski sistemi, ki jih uporablja agencija za shranjevanje podatkov, vključno z zaupnimi in osebnimi podatki, so zasnovani tako, da zagotavljajo visoko raven varnosti, primerno varnostnim tveganjem, pri čemer se upoštevajo členi 39 do 39f te uredbe.

en	It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority.
sl	Bistvenega pomena je, da je vloga za odobritev, ki se predloži Agenciji za oceno tveganja, v skladu z veljavnimi specifikacijami, da se zagotovi, da Agencija pripravi znanstveno oceno najvišje kakovosti.

en	(a) The Authority shall draw up draft standard data formats and software packages for the purposes of the different authorisation procedures in Union food law and relevant requests for a scientific output by the European Parliament, the Commission and the Member States.
sl	(a) Agencija predlaga standardne oblike zapisa podatkov in pakete programske opreme za različne odobritvene postopke v živilski zakonodaji Unije in zadevna zaprosila Evropskega parlamenta, Komisije in držav članic za znanstveni prispevek.

en	Governance and greater Member State involvement in nominating Scientific Panel experts: the benefit of greater Member State involvement in this aspect of EFSA's work is expected to be to ensure it has access to a sufficiently large pool of independent and excellent experts meeting its needs in the different disciplines areas it deals with.
sl	Upravljanje in večja vključenost držav članic pri imenovanju strokovnjakov znanstvenih svetov: Večja vključenost držav članic v ta vidik dela agencije EFSA naj bi agenciji zagotovila dostop do zadosti velikega nabora neodvisnih in odličnih strokovnjakov, ki izpolnjujejo njene potrebe na različnih področjih njenega dela.

en	The lack of legal basis to audit the monitoring authorities of non-European Union countries is dealt with by coordinating activities with the Member States and OECD GLP programmes and by seeking to conclude bilateral international agreements.
sl	Zaradi odsotnosti pravne podlage za presojo nadzornih organov držav nečlanic EU se usklajujejo dejavnosti med državami članicami in programi OECD za dobro laboratorijsko prakso, potekajo pa tudi prizadevanja za sklenitev dvostranskih mednarodnih sporazumov.

en	As confirmed in the recently published Fitness Check of the GFL Regulation (GFL Fitness Check), the rigorous implementation of the risk analysis principle throughout the Union law has overall raised the level of protection from potential food safety risks in a number of ways.
sl	Kot je bilo potrjeno v nedavno objavljenem preverjanju ustreznosti uredbe o splošni živilski zakonodaji, se je zaradi strogega izvajanja načela analize tveganja v celotnem pravu Unije na splošno povečala stopnja zaščite pred potencialnimi tveganji v zvezi z varnostjo hrane, in sicer na več načinov.

en	Auditing by the European Commission: This will strengthen the guarantees on the quality of the studies EFSA takes into consideration in its risk assessments, in particular with regard to the reproducibility of results.
sl	Presoje, ki jih izvaja Evropska komisija: Z njimi se bodo okrepila jamstva za kakovost študij, ki jih EFSA upošteva pri svojih ocenah tveganja, zlasti v zvezi s ponovljivostjo rezultatov.

en	Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should be responsible for triggering the commissioning of such verification studies.
sl	Ker bi se tako izjemno orodje za preverjanje financiralo iz proračuna Unije in ker bi morala njegova uporaba ostati sorazmerna, bi morala biti za naročila takih preveritvenih študij odgovorna Komisija.

en	"(c) The Authority shall:
sl	„(c) Agencija:

en	Strengthen advocacy: targeted messages, narrative, translations etc 4.8 FTEs 0.248 0.434 0.620
sl	Krepitev zagovorništva: ciljna sporočila, predstavitve, prevodi itd. 4,8 EPDČ 0,248 0,434 0,620

en	Heading of multiannual financial
sl	Razdelek večletnega finančnega

en	(d) the information on which its scientific outputs, including scientific opinions are based, taking into account protection of confidential data and protection of personal data in accordance with Articles 39 to 39f;
sl	(d) informacije, na katerih temeljijo njeni znanstveni prispevki, vključno z znanstvenimi mnenji, pri čemer upošteva varstvo zaupnih podatkov in varstvo osebnih podatkov v skladu s členi 39 do 39f;

en	The proposal at hand provides for a periodic overall evaluation of the agency, to be commissioned by the Commission, as per the Common Approach on Decentralised Agencies.
sl	Ta predlog določa redno splošno oceno agencije, ki jo naroči Komisija na podlagi skupnega pristopa k decentraliziranim agencijam.

en	The non-confidential version shall be without the information the applicant deems confidential in accordance with paragraphs 2 and 3 of Article 39.
sl	Nezaupna različica ne vsebuje informacij, ki jih vlagatelj v skladu z odstavkoma 2 in 3 člena 39 šteje za zaupne.

en	It also attaches continuous importance to the quality and independence of scientific studies that are the basis of the EU risk assessment carried out by EFSA".
sl	Prav tako pripisuje stalno pomembnost kakovosti in neodvisnosti znanstvenih študij, na katerih temelji ocenjevanje tveganja na ravni EU, ki ga izvaja EFSA.

en	Decision on confidentiality
sl	Odločitev o zaupnosti

en	The applicant shall clearly indicate the grounds on the basis of which confidentiality is requested for the different pieces of information.
sl	Vlagatelj jasno navede razloge, zaradi katerih zahteva zaupnost posameznih informacij.

en	The Commission will bear the limited costs.
sl	Stroški so omejeni, krila pa jih bo Komisija.

en	Information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparency.
sl	Informacije o priglašenih študijah bi bilo treba objaviti šele po objavi ustrezne vloge za odobritev v skladu z veljavnimi pravili o preglednosti.

en	tighten and clarify the rules on transparency, especially with regard to the scientific studies used as the basis for risk assessment the EFSA carries out;
sl	poostritve in pojasnitve pravil o preglednosti, zlasti glede znanstvenih študij, uporabljenih kot podlaga za oceno tveganja, ki jo opravi EFSA;

en	To increase the effectiveness of the consultation, the consultation should take place when the studies submitted by industry included in an application for authorisation are made public, under the transparency rules of this Regulation.
sl	Da bi povečali učinkovitost posvetovanja, bi to moralo potekati po objavi študij iz vloge za odobritev, ki jih je predložila industrija, v skladu s pravili o preglednosti iz te uredbe.

en	This principle is based on the premise that public health is better protected when the burden is on the applicant to prove that a particular food or feed is safe prior to its placing on the market, instead of the public authorities having to prove that it is unsafe.
sl	To načelo temelji na predpostavki, da se javno zdravje bolje varuje, če mora vlagatelj dokazati, da je določeno živilo ali krma varna, preden se da na trg, ne pa da morajo javni organi dokazovati, da proizvod ni varen.

en	The impact on the timing of authorisation is minimal since the notification of commissioned studies takes place at the pre-submission stage and the risk assessment will run in parallel of the consultation on submitted studies
sl	Učinek na časovni potek odobritve je zelo majhen, saj obveščanje o naročenih študijah poteka pred vložitvijo vloge, ocena tveganja pa bo opravljena hkrati s posvetovanjem o predloženih študijah.

en	Before the Authority issues its scientific outputs, including scientific opinions, it shall review whether information that has been previously accepted as confidential may nevertheless be made public in accordance with paragraph 4(b) of Article 39.
sl	Preden agencija izda svoje znanstvene prispevke, vključno z znanstvenimi mnenji, preuči, ali se lahko informacije, za katere je bila pred tem odobrena zaupna obravnava, vseeno objavijo v skladu z odstavkom 4(b) člena 39.

en	The proposal will provide for a series of measures to ensure that EFSA has access to the broadest relevant scientific evidence possible related to a request for authorisation and to increase the guarantees of reliability, objectivity and independence of studies used by EFSA in its risk assessment.
sl	Predlog bo določal vrsto ukrepov, s katerimi se bo agenciji EFSA zagotovil dostop do čim obsežnejših relevantnih znanstvenih dokazov v zvezi z vlogo za odobritev in s katerimi se bodo povečala jamstva glede zanesljivosti, objektivnosti in neodvisnosti študij, ki jih EFSA uporabi v svojih ocenah tveganja.

en	In particular, the Executive Director, whose function is to defend EFSA's independent point of view and interests, selects the experts proposed for appointment to the Management Board from the large pool of experts nominated by Member States.
sl	Izvršni direktor, katerega naloga je zaščititi neodvisnost in interese agencije EFSA, izbere strokovnjake, ki jih je za imenovanje predlagal upravni odbor izmed velikega števila strokovnjakov, ki so jih predlagale države članice.

en	In drafting the proposal, contributions have been taken into account for measures in four specific areas: the publication of studies supporting industry applications of regulated products while protecting confidential and personal data; guarantees in the Union to verify the reliability, and independence of the evidence taken from industry studies; making risk communication more efficient; and strengthening EFSA's sustainability and governance while ensuring the independence and excellence of the expertise made available to the Authority by the Union Member States.
sl	Pri pripravi predloga so bili upoštevani prispevki za ukrepe na štirih posebnih področjih: objava študij v podporo vlogam industrije za regulirane proizvode, pri čemer se zagotavlja varstvo zaupnih in osebnih podatkov; jamstva v Uniji za preverjanje zanesljivosti in neodvisnosti dokazov iz študij industrije; učinkovitejše obveščanje o tveganju ter krepitev vzdržnosti in upravljanja agencije EFSA ob hkratnem zagotavljanju neodvisnosti in odličnosti strokovnega znanja, ki ga dajo agenciji na voljo države članice Unije.

en	(d) Where standard data formats and software packages have been adopted pursuant to this article, applications as well as requests for a scientific output, including a scientific opinion by the European Parliament, the Commission and the Member States under Union food law, shall only be submitted in accordance with the standard data formats and software packages laid down in those acts.
sl	(d) Kadar so bili v skladu s tem členom sprejeti standardne oblike zapisa podatkov in paketi programske opreme, se vloge in zaprosila za znanstvene prispevke, vključno z zaprosili Evropskega parlamenta, Komisije in držav članic za znanstveno mnenje na podlagi živilske zakonodaje Unije, predložijo le v skladu s standardnimi oblikami zapisa podatkov in paketi programske opreme, ki so določeni v navedenih aktih.

en	(c) scientific data, studies and other information supporting applications for authorisation under Union food law, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific output, including a scientific opinion, taking into account protection of confidential information and protection of personal data in accordance with Articles 39 to 39f.
sl	(c) znanstvene podatke, študije in druge informacije v podporo vlogam za odobritev na podlagi živilske zakonodaje Unije, vključno z dodatnimi informacijami, ki so jih predložili vlagatelji, ter druge znanstvene podatke in informacije v podporo zaprosilom Evropskega parlamenta, Komisije in držav članic za znanstvene prispevke, vključno z znanstvenim mnenjem, pri čemer upošteva varstvo zaupnih informacij in varstvo osebnih podatkov v skladu s členi 39 do 39f.

en	Amendments to Regulation (EC) No 1829/2003 on genetically modified food and feed
sl	Spremembe Uredbe (ES) št. 1829/2003 o gensko spremenjenih živilih in krmi

en	To improve transparency of studies and address the societal concerns for a more transparent and independent risk assessment process and a more effective risk communication.
sl	Izboljšanje preglednosti študij in obravnavanje družbenih pomislekov za preglednejši in bolj neodvisen postopek ocenjevanja tveganja ter učinkovitejše obveščanje o tveganju.

en	Without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances, may request the Authority to commission scientific studies with the objective of verifying evidence used in its risk assessment process.
sl	Brez poseganja v obveznost vlagateljev vlog za odobritev na podlagi živilske zakonodaje, da dokažejo varnost predmeta, predloženega v sistem odobritve, lahko Komisija v izjemnih okoliščinah od agencije zahteva, da naroči znanstvene študije za preverjanje dokazov, uporabljenih v postopku ocenjevanja tveganja.

en	The Authority shall make available, upon request, to the Commission and the Member States all information in its possession relating to an application for an authorisation or to a request by the European Parliament, the Commission or the Member States for a scientific output, including a scientific opinion, unless otherwise indicated in specific Union food law.
sl	Na zahtevo da Agencija Komisiji in državam članicam na voljo vse informacije, ki jih ima v zvezi z vlogo za odobritev ali zaprosilom Evropskega parlamenta, Komisije ali držav članic za znanstveni prispevek, vključno z znanstvenim mnenjem, razen če je v posebni živilski zakonodaji Unije določeno drugače.

en	The Commission and the Member States shall also take the necessary measures so that information for which confidential treatment has been accepted by the Authority is not made public.
sl	Komisija in države članice sprejmejo tudi potrebne ukrepe, da ne objavijo informacij, za katere je agencija odobrila zaupno obravnavo.

en	(9) Transparency of the risk assessment process contributes to the Authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing its mission, increases their confidence in its work and ensures that the Authority is more accountable to the Union citizens in a democratic system.
sl	(9) Preglednost postopka ocenjevanja tveganja prispeva k temu, da potrošniki in splošna javnost v večji meri priznavajo legitimnost Agencije za izpolnjevanje njenih nalog, povečuje njihovo zaupanje v delo Agencije ter zagotavlja, da je Agencija bolj odgovorna državljanom Unije v demokratičnem sistemu.

en	When submitting an application for an authorisation, supporting scientific data and other supplementary information in accordance with Union food law, the applicant may request certain parts of the information submitted to be kept confidential in accordance with paragraphs 2 and 3 of Article 39.
sl	Ob predložitvi vloge za odobritev, podpornih znanstvenih podatkov in drugih dodatnih informacij v skladu z živilsko zakonodajo Unije lahko vlagatelj zahteva, da se nekatere predložene informacije v skladu z odstavkoma 2 in 3 člena 39 obravnavajo zaupno.

en	It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted, while not entering into the design of the studies to be submitted that remain the applicant's responsibility.
sl	Zato bi bilo primerno, da bi Agencija na zahtevo svetovala morebitnemu vlagatelju o veljavnih pravilih in zahtevani vsebini vloge za odobritev, preden se vloga uradno vloži, ne da bi pri tem obravnavala zasnovo študij, ki jih je treba predložiti, za kar bi bil še naprej odgovoren vlagatelj.

en	Amendments to Regulation (EC) No 1935/2004 on Food Contact Materials
sl	Spremembe Uredbe (ES) št. 1935/2004 o materialih, namenjenih za stik z živili

en	Any personal data made public pursuant to Article 38 and this article shall only be used to ensure the transparency of risk assessment process under this Regulation and not be further processed in a manner that is incompatible with these purposes, in the meaning of Article 5(1)(b) of Regulation (EU) 2016/679 and Article 4(1)(b) of Regulation (EC) No 45/2001, as the case may be.
sl	Vsi osebni podatki, objavljeni v skladu s členom 38 in tem členom, se uporabljajo samo za zagotovitev preglednosti postopka ocenjevanja tveganja na podlagi te uredbe in se ne smejo nadalje obdelovati na način, ki ni združljiv s temi nameni, v smislu člena 5(1)(b) Uredbe (EU) 2016/679 in člena 4(1)(b) Uredbe (ES) št. 45/2001, odvisno od primera.

en	Contract agents Year
sl	Pogodbeni uslužbenci Leto

en	Seconded National Experts Year
sl	Napoteni nacionalni strokovnjaki Leto

en	[13: Proposal for a Regulation of the European Parliament and of the Council adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union, COM(2016)799 final, dated 14.12.2016.]
sl	[13: Predlog uredbe Evropskega parlamenta in Sveta o prilagoditvi številnih zakonodajnih aktov, v katerih je določena uporaba regulativnega postopka s pregledom, členoma 290 in 291 Pogodbe o delovanju Evropske unije, COM(2016) 799 final, z dne 14. 12.

en	The Authority may only accept to provide confidential treatment in relation to the following information, the disclosure of which may be deemed, upon verifiable justification, to significantly harm the interests concerned:
sl	Agencija lahko odobri samo zaupno obravnavo naslednjih informacij, katerih razkritje bi lahko na podlagi preverljive utemeljitve znatno škodovalo zadevnim interesom:

en	IT support for data disclosure Licences/maintenance/storage/security 0.960 1.680 2.400 2.400 2.400 9.840
sl	Informacijska podpora za objavljanje podatkov Licence/vzdrževanje/shranjevanje/varnost 0,960 1,680 2,400 2,400 2,400 9,840

en	(5) Particular emphasis should be placed on explaining in a coherent, appropriate and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors, where relevant.
sl	(5) Posebno pozornost bi bilo treba nameniti skladni, ustrezni in pravočasni razlagi ugotovitev ocene tveganja ter tudi načinov, kako te pripomorejo k odločitvam za obvladovanje tveganja, skupaj z drugimi upoštevanja vrednimi dejavniki, kadar je to ustrezno.

en	The Authority shall apply Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents when handling applications for access to documents held by the Authority.
sl	Agencija pri obravnavanju vlog za dostop do dokumentov, ki jih hrani, uporablja Uredbo Evropskega parlamenta in Sveta (ES) št. 1049/2001 z dne 30. maja 2001 o dostopu javnosti do dokumentov Evropskega parlamenta, Sveta in Komisije.

en	(18) The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law.
sl	(18) Agencija bi morala poznati predmet vseh študij, ki jih izvede vlagatelj v zvezi s prihodnjo vlogo za odobritev na podlagi živilske zakonodaje Unije.

en	When submitting the application, the applicant may pursuant to Article 63 request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.
sl	Ob predložitvi zahtevka lahko vlagatelj v skladu s členom 63 zaprosi, da se nekatere informacije in nekateri deli dokumentacije obravnavajo zaupno, ter take informacije fizično loči.

en	Subtotal for specific objective No 4 2.800 4.900 7.000 7.000 7.000 28.700
sl	Seštevek za specifični cilj št. 4 2,800 4,900 7,000 7,000 7,000 28,700

en	(27) To determine what level of disclosure strikes the appropriate balance, the relevant rights of the public to transparency in the risk assessment process, should be weighted up against the rights of commercial applicants, taking into account the objectives of Regulation (EC) No 178/2002.
sl	(27) Za določitev ravni razkritja, ki zagotavlja primerno ravnotežje, bi bilo treba ustrezne pravice javnosti do preglednosti v postopku ocenjevanja tveganja ponderirati glede na pravice poslovnih vlagateljev, ob upoštevanju ciljev Uredbe (ES) št. 178/2002.

en	(c) On the basis of the nominations made by Member States, the Executive Director shall draw for each Scientific Panel a list of experts larger than the number of members to be appointed.
sl	(c) Na podlagi predlogov držav članic izvršni direktor za vsak znanstveni svet pripravi seznam strokovnjakov, ki vključuje več imen, kot je število članov, ki bodo imenovani.

en	"Article 57a
sl	„Člen 57a

en	Taking into account the respective roles of risk assessors and risk managers, risk communication shall:
sl	Ob upoštevanju vlog odgovornih za oceno tveganja in odgovornih za obvladovanje tveganja mora obveščanje o tveganju:

en	The pre-submission procedure ensures an additional involvement of EFSA, to ensure that the applicant is aware of and can adhere to the applicable requirements relating to the content of authorisation applications.
sl	S postopkom pred vložitvijo vloge se zagotavlja dodatna vključenost agencije EFSA, da se zagotovi seznanjenost vlagatelja z veljavnimi zahtevami v zvezi z vsebino vlog za odobritev in njihovo upoštevanje.

en	The main objective of the proposal is to make studies used in risk assessment more transparent and address the demands of society for a more transparent and independent risk assessment process and more effective risk communication.
sl	Glavni cilj predloga je povečati preglednost študij, uporabljenih v oceni tveganja, ter se odzvati na zahteve družbe po bolj preglednem in neodvisnem postopku ocenjevanja tveganja ter učinkovitejšem obveščanju o tveganju.

en	Verification studies
sl	Preveritvene študije

en	Where an applicant submits a request for confidentiality, it shall provide a non-confidential version and a confidential version of the information submitted in accordance with standard data formats, where they exist, pursuant to Article 39f.
sl	Kadar vlagatelj vloži zahtevo za zaupnost, predloži nezaupno in zaupno različico predloženih informacij v standardnih oblikah zapisa podatkov, če te obstajajo, v skladu s členom 39f.

en	(b) Member States shall nominate experts with a view to collectively reach the number indicated by the Executive Director.
sl	(b) Države članice predlagajo strokovnjake, njihovo skupno število pa mora doseči število, ki ga navede izvršni direktor.

en	It is proposed to lay down in legislation the objectives and general principles governing risk communication, taking into account the respective roles of risk assessors and managers pursuant to Article 40 of Regulation (EC) No 178/2002 and, based on these objectives and general principles, to draw up a general plan on risk communication ("general plan").
sl	Predlagano je, da se v zakonodaji določijo cilji in splošna načela za obveščanje o tveganju, ob upoštevanju vlog odgovornih za oceno tveganja in odgovornih za obvladovanje tveganja v skladu s členom 40 Uredbe (ES) št. 178/2002, in da se na podlagi teh ciljev in splošnih načel sestavi splošni načrt obveščanja o tveganju („splošni načrt").

en	If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f.
sl	Če vlagatelj v postopku odobritve umakne vlogo, agencija, Komisija in države članice upoštevajo zaupnost poslovnih in industrijskih informacij, kot jo je odobrila agencija v skladu s členi 39 do 39f.

en	The notified information shall be made public only in case a corresponding application for authorisation has been received and after the Authority has decided on the disclosure of the accompanying studies in accordance with Article 38 and Articles 39 to 39f.
sl	Sporočene informacije se objavijo samo v primeru prejetja ustrezne vloge za odobritev in po tem, ko agencija sprejme odločitev o razkritju spremljajočih študij v skladu s členom 38 in členi 39 do 39f.

en	In particular, the new provisions provide that all supporting data and information relating to applications for authorisation are to be made public by EFSA upon receipt (as applications will be submitted either directly to EFSA or forwarded to EFSA by Member States or by the Commission), including supplementary information, except for duly justified confidentiality information.
sl	V novih določbah je zlasti določeno, da mora EFSA po prejemu (vloge se ji predložijo neposredno ali pa ji jih posredujejo države članice ali Komisija) objaviti vse podporne podatke in informacije v zvezi z vlogami odobritev, vključno z dodatnimi informacijami, razen v primeru ustrezno utemeljenih zaupnih informacij.

en	The Authority shall support the tasks of the Panels by organising their work, in particular the preparatory work to be undertaken by the Authority's staff or by designated national scientific organisations referred to in the Article 36 including by organising the possibility for preparing scientific opinions to be peer-reviewed by the Panels before they adopt them.
sl	Agencija podpira naloge znanstvenih svetov, tako da organizira njihovo delo, zlasti pripravljalno delo, ki ga izvaja osebje agencije ali imenovane nacionalne znanstvene organizacije iz člena 36, tudi z organiziranjem možnosti za pripravo znanstvenih mnenj, ki jih morajo znanstveni sveti strokovno pregledati, preden jih sprejmejo.

en	Evidence has pointed to occasional divergences and, in very few occasions, conflicting communications amongst Union and national risk assessors and risk managers, which may have an adverse impact on public perception as regards the assessment and management of risk related to the agri-food chain.
sl	Dokazana so bila občasna razhajanja v mnenjih in v zelo redkih primerih nasprotujoče si obveščanje med odgovornimi za oceno tveganja in odgovornimi za obvladovanje tveganja na ravni Unije ter med tistimi na nacionalni ravni, kar bi lahko negativno vplivalo na javno dojemanje ocenjevanja in obvladovanja tveganja v agroživilski verigi.

en	Amendments to Regulation (EC) 1831/2003 on feed additives
sl	Spremembe Uredbe (ES) 1831/2003 o krmnih dodatkih

en	(a) agendas and minutes of the Scientific Committee and the Scientific Panels and their Working Groups;
sl	(a) dnevne rede in zapisnike zasedanj znanstvenega odbora in znanstvenih svetov ter njihovih delovnih skupin;

en	Obligations with regard to confidentiality
sl	Obveznosti glede zaupnosti

en	(b) the competent authority shall assess the confidentiality request submitted by the notifier/applicant.
sl	(b) pristojni organ oceni zahtevo za zaupnost, ki jo je predložil prijavitelj/vlagatelj.

en	The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 of this Regulation shall start either on the Commission's initiative or following an application to the Commission by an applicant, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002.
sl	Postopek za odobritev dajanja novega živila na trg v Uniji ter posodobitev seznama Unije iz člena 9 te uredbe se začne na pobudo Komisije ali na podlagi vloge, ki jo vložnik predloži Komisiji v standardnih oblikah zapisa podatkov, če te obstajajo, v skladu s členom 39f Uredbe (ES) št. 178/2002.

en	This request shall be accompanied by verifiable justification demonstrating how making public the information concerned significantly harms the interests concerned in accordance with paragraphs 2 and 3 of Article 39.
sl	Temu zahtevku se priloži preverljiva utemeljitev, v kateri je prikazano, kako bi objava zadevnih informacij v skladu s členom 39(2) in (3) znatno škodovala zadevnim interesom.

en	(26) Where the opinion of the Authority is requested in relation to authorisation procedures under Union food law and having regard to its obligation to ensure public access to all supporting information with respect to the provision of its scientific outputs, the Authority should have responsibility for assessing confidentiality requests.
sl	(26) Kadar je Agencija zaprošena za mnenje v zvezi s postopki odobritve na podlagi živilske zakonodaje Unije, bi morala biti glede na svojo obveznost, da zagotovi javni dostop do vseh podpornih informacij v zvezi s pripravo znanstvenih prispevkov, odgovorna za ocenjevanje zahtev za zaupnost.

en	Review clause
sl	Klavzula ponovnega pregleda

en	To determine what level of disclosure strikes the appropriate balance, the public interest in ensuring greater transparency in the risk assessment process is weighted up against the commercial interests at stake.
sl	Da bi se ugotovilo, s katero stopnjo razkritja bi se doseglo primerno ravnovesje, se pretehtajo javni interes zagotavljanja večje preglednosti v postopku ocenjevanja tveganja ter zadevni poslovni interesi.

en	When the Authority identifies that specific expertise is missing in a Panel or several Panels, the Executive Director shall propose additional members of the Panel(s) for appointment to the Management Board in accordance with the procedure laid down in paragraph 5.
sl	Kadar agencija ugotovi, da v enem ali več znanstvenih svetih manjka posebno strokovno znanje, izvršni direktor upravnemu odboru predlaga imenovanje dodatnih članov znanstvenega sveta oziroma svetov v skladu s postopkom iz odstavka 5.

en	Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY
sl	trajanje predloga/pobude od [D. MMMM] LLLL do [D. MMMM] LLLL,

en	A decision to revoke shall put an end to the delegation of power specified in that decision.
sl	S sklepom o preklicu preneha veljati prenos pooblastila iz navedenega sklepa.

en	Amendments to Regulation (EC) No 1331/2008 on the common authorisation procedure for food additives, food enzymes and food flavourings
sl	Spremembe Uredbe (ES) št. 1331/2008 o skupnem postopku odobritve za aditive za živila, encime za živila in arome za živila

en	"The Authority shall ensure public access to the notification pursuant to Article 23.
sl	„Agencija v skladu s členom 23 zagotovi javni dostop do priglasitve.

en	SPECIFIC OBJECTIVE No 4 develop a more effective and transparent risk communication with the public in collaboration with Member States
sl	SPECIFIČNI CILJ št. 4 razviti učinkovitejše in preglednejše obveščanje javnosti o tveganju v sodelovanju z državami članicami

en	Risk assessment is defined as the scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation.
sl	Ocena tveganja je opredeljena kot postopek na znanstveni podlagi, sestavljen iz štirih korakov: prepoznavanja nevarnosti, opredelitve nevarnosti, ocene izpostavljenosti in opredelitve tveganja.

en	Strengthened analysis of social science survey analysis 0.500 0.875 1.250 1.250 1.250 5.125
sl	Okrepljena analiza: družboslovne raziskave, analize 0,500 0,875 1,250 1,250 1,250 5,125

en	Where an opinion by the Authority is not required in accordance with Article 3(2) of this Regulation, the Commission shall assess the confidentiality request submitted by the applicant.
sl	Kadar mnenje Agencije v skladu s členom 3(2) te uredbe ni potrebno, Komisija oceni zahtevo za zaupnost, ki jo je vložil predlagatelj.

en	SPECIFIC OBJECTIVE No 3 improve the governance, strengthen the involvement of Member States and address the limitations affecting the long term scientific capacity of EFSA
sl	SPECIFIČNI CILJ št. 3 izboljšati upravljanje, okrepiti vključenost držav članic ter odpraviti omejitve, ki vplivajo na dolgoročno znanstveno zmogljivost agencije EFSA

en	Officials (AD Grades)
sl	Uradniki (razredi AD)

en	Estimated impact on the staff (additional) - external personnel
sl	Ocenjene posledice za uslužbence (dodatno) - zunanji sodelavci

en	The proposal is expected to contribute to the Union risk assessment system acquiring greater legitimacy in the eyes of the Union consumers and general public, increasing their confidence in its outcome and ensure that it is more accountable to the Union citizens.
sl	Pričakuje se, da bo predlog prispeval k sistemu Unije za ocenjevanje tveganja, tako da bodo potrošniki in splošna javnost v Uniji v večji meri priznavali njegovo legitimnost, pri čemer se bo povečalo njihovo zaupanje v rezultate in zagotovilo, da bo sistem bolj odgovoren državljanom Unije.

en	Regulation (EU) No 2015/2283 is amended as follows:
sl	Uredba (EU) 2015/2283 se spremeni:

en	The specific obligations in the case of renewals of authorisations: The obligation to notify EFSA of planned studies and to systematically carry out consultation on these planned studies with the EFSA issuing systematic advice on the content of the intended application are expected to have a positive balance of effects.
sl	Posebne obveznosti v primeru obnovitev odobritev: Obveznosti obveščanja agencije EFSA o načrtovanih študijah ter sistematičnega posvetovanja o teh načrtovanih študijah, skupaj z izdajo sistematičnih mnenj agencije EFSA o vsebini predvidene vloge, naj bi imele pozitivne učinke.

en	Amendments to Regulation (EC) No 2065/2003 on smoke flavourings
sl	Spremembe Uredbe (ES) št. 2065/2003 o aromah dima

en	Additional ad hoc studies 16 ad hoc studies 6.000 10.500 15.000 15.000 15.000 61.500
sl	Dodatne študije ad hoc 16 študij ad hoc 6,000 10,500 15,000 15,000 15,000 61,500

en	This urgent proposal draws up from the findings of the Fitness Check of the GFL Regulation and is based on the commitments made by the Commission's reply to the ECI Communication.
sl	Ta nujni predlog temelji na ugotovitvah preverjanja ustreznosti uredbe o splošni živilski zakonodaji in na zavezah iz odgovora Komisije na evropsko državljansko pobudo.

en	(b) the following paragraphs 1a and 1b are inserted:
sl	(b) vstavita se naslednja odstavka 1a in 1b:

en	Regulation (EC) No 178/2002, Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003 and Regulation (EC) No 2065/2003 are currently included in the Commission's horizontal alignment legislative proposal adopted in 2016.
sl	Uredba (ES) št. 178/2002, Direktiva 2001/18/ES, Uredba (ES) št. 1829/2003, Uredba (ES) št. 1831/2003 in Uredba (ES) št. 2065/2003 so trenutno vključene v zakonodajni predlog Komisije za horizontalno uskladitev, sprejet leta 2016.

en	Where the Commission does not request the Authority's opinion pursuant to Articles 10 and 16, the Commission shall assess the confidentiality request submitted by the applicant.
sl	Kadar Komisija v skladu s členoma 10 in 16 Agencije ne zaprosi za mnenje, Komisija oceni zahtevo za zaupnost, ki jo je predložil vložnik.

en	NO YES
sl	/NE DA

en	There should be no negative impact for innovation from the measures on the reliability and robustness of studies.
sl	Ukrepi za zanesljivost in trdnost študij ne bi smeli negativno vplivati na inovacije.

en	Capacity building 2.4 FTEs 0.124 0.217 0.310
sl	Krepitev zmogljivosti 2,4 EPDČ 0,124 0,217 0,310

en	[27: Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers, (OJ L 55, 28.2.2011, p.
sl	[27: Uredba (EU) št. 182/2011 Evropskega parlamenta in Sveta z dne 16. februarja 2011 o določitvi splošnih pravil in načel, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije (UL L 55, 28.2.2011, str.

en	The general plan for risk communication shall promote an integrated risk communication framework to be followed both by the risk assessors and the risk managers in a coherent and systematic manner both at Union and national level.
sl	Splošni načrt obveščanja o tveganju spodbuja celosten okvir za obveščanje o tveganju, ki ga morajo dosledno in sistematično upoštevati odgovorni za oceno tveganja in odgovorni za obvladovanje tveganja na ravni Unije in na nacionalni ravni.

en	(24) The European Citizens' Initiative "Ban glyphosate and protect people and the environment from toxic pesticides" further confirmed concerns regarding transparency with respect to studies commissioned by the industry and submitted in authorisation application.
sl	(24) Evropska državljanska pobuda „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi" je dodatno potrdila pomisleke glede preglednosti v zvezi s študijami, ki jih naroča industrija in se predložijo vlogam za odobritev.

en	Temporary staff 4.861 8.507 12.154 12.154 12.154 49.830
sl	Začasni uslužbenci 4,861 8,507 12,154 12,154 12,154 49,830

en	3) improve the governance, strengthen the involvement of Member States and address the limitations affecting the long term scientific capacity of EFSA taking also account of the related financial and budgetary aspects,
sl	3) izboljšati upravljanje, okrepiti vključenost držav članic ter odpraviti omejitve, ki vplivajo na dolgoročno znanstveno zmogljivost agencije EFSA, pri čemer se upoštevajo tudi s tem povezani finančni in proračunski vidiki;

en	Subtotal for specific objective No 1 1.120 1.960 2.800 2.800 2.800 11.480
sl	Seštevek za specifični cilj št. 1 1,120 1,960 2,800 2,800 2,800 11,480

en	(6) To this effect, it is necessary to establish general objectives and principles of risk communication, taking into account the respective roles of risk assessors and managers.
sl	(6) V ta namen je treba določiti splošne cilje in načela obveščanja o tveganju, ob upoštevanju vloge odgovornih za oceno tveganja in odgovornih za obvladovanje tveganja.

en	On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether an authorisation for a product referred to in Article 15(1) still meets the conditions set by this Regulation.
sl	Agencija na lastno pobudo ali na zahtevo države članice ali Komisije da svoje mnenje o tem, ali odobritev za proizvod iz člena 15(1) še vedno izpolnjuje pogoje, določene s to uredbo.

en	(16) Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession.
sl	(16) Postopki odobritve temeljijo na načelu, da mora vlagatelj dokazati, da predmet postopka odobritve izpolnjuje varnostne zahteve Unije glede na znanstvena dognanja, s katerimi razpolaga.

en	In addition, unlike in the case of other Union Agencies, EFSA governance has not yet been brought in line with the Common Approach on Union decentralised agencies, including with regard to the composition of its Management Board.
sl	Poleg tega upravljanje agencije EFSA, v nasprotju z drugimi agencijami Unije, še ni usklajeno s skupnim pristopom k decentraliziranim agencijam Unije, tudi glede sestave upravnega odbora.

en	Additional ad hoc studies 4FTEs 0.207 0.362 0.517
sl	Dodatne študije ad hoc 4 EPDČ 0,207 0,362 0,517

en	(b) the Authority shall assess the confidentiality request submitted by the applicant.
sl	(b) Agencija oceni zahtevo za zaupnost, ki jo je predložil vlagatelj.

en	(b) the trademark under which the substance, shall be marketed as well as the tradename of the preparations, material or articles in which it shall be used, where applicable; and,
sl	(b) blagovne znamke, pod katero se snov trži, ter, kadar je to ustrezno, trgovskega imena pripravkov, materialov ali izdelkov, v katerih se snov uporablja; ter

en	It will also address the findings of the GFL Fitness Check that identified challenges to EFSA's capacity to maintain its high level of scientific expertise by providing for an increased involvement of Member States in the nomination process of Panels' members.
sl	Obravnaval bo tudi ugotovitve preverjanja ustreznosti splošne živilske zakonodaje, pri katerem so bili opredeljeni izzivi v zvezi z zmogljivostjo agencije EFSA za ohranjanje visoke ravni strokovnega znanja s povečano vključenostjo držav članic v postopek imenovanja članov znanstvenih svetov.

en	Risk assessment at Union level is carried out by an autonomous agency established by the GFL Regulation, the European Food Safety Authority (EFSA), separately from the risk management function of the Union Institutions, and mainly that of the Commission.
sl	Evropska agencija za varnost hrane (EFSA), ustanovljena z uredbo o splošni živilski zakonodaji, in sicer ločeno od naloge obvladovanja tveganja, ki jo opravljajo institucije Unije, zlasti Komisija.

en	Estimated impact on EFSA expenditure
sl	Ocenjene posledice za odhodke EFSA

en	"Article 39
sl	„Člen 39

en	Capacity building 10 panels/21 members 7 days/training /y 0.224 0.392 0.560 0.560 0.560 2.296
sl	Krepitev zmogljivosti 10 svetov/21 članov 7 dni usposabljanja/leto 0,224 0,392 0,560 0,560 0,560 2,296

en	It is also proportionate given that the applicant can get useful advice on the content of its intended application following the consultation on the planned studies and this at an early stage of the process.
sl	Poleg tega je tudi sorazmerno, saj lahko vlagatelj v posvetovanju o načrtovanih študijah že v zgodnji fazi postopka pridobi koristne nasvete o vsebini predvidene vloge.

en	The Authority shall lay down in its internal rules the practical arrangements for implementing the confidentiality rules laid down in Articles 39, 39a, 39b, 39e and this Article, including arrangements concerning the submission and treatment of confidentiality requests with respect to information to be made public under Article 38, and taking into account Articles 39f and 39g.
sl	Agencija v svojem poslovniku določi praktično ureditev za izvajanje pravil o zaupnosti iz členov 39, 39a, 39b, 39e in tega člena, vključno z ureditvijo glede vložitve in obravnavanja zahtev za zaupnost v zvezi z informacijami, ki jih je treba objaviti v skladu s členom 38, ter ob upoštevanju členov 39f in 39 g.";

en	[Heading……………………...…………] Diff./Non-diff.[44: Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.]
sl	[44: Dif. = diferencirana sredstva / nedif.

en	[16: Commission Staff Working Document, Synopsis Report, SWD(2018)97, [dated 11.04.2018].]
sl	[16: Delovni dokument služb Komisije, Zbirno poročilo, SWD(2018) 97, [z dne 11. 4.

en	On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether an authorisation for a product referred to in Article 3(1) still meets the conditions set by this Regulation.
sl	Agencija na lastno pobudo ali na zahtevo države članice ali Komisije da svoje mnenje o tem, ali odobritev za proizvod iz člena 3(1) še vedno izpolnjuje pogoje, določene s to uredbo.

en	Business operators shall notify, without delay, to the Authority the subject matter of any study commissioned to support a future application for an authorisation under Union food law.
sl	Nosilci dejavnosti morajo agencijo nemudoma uradno obvestiti o predmetu katere koli študije, naročene v podporo prihodnji vlogi za odobritev na podlagi živilske zakonodaje Unije.

en	Consultation of third parties
sl	Posvetovanje s tretjimi osebami

en	Contract staff 0.629 1.101 1.572 1.572 1.572 6.446
sl	Pogodbeni uslužbenci 0,629 1,101 1,572 1,572 1,572 6,446

en	Finally, the proposal introduces the possibility for the Commission to request EFSA to commission studies in exceptional circumstances (e.g. controversies) for the purpose of verification.
sl	Nazadnje, predlog uvaja možnost, da Komisija v izjemnih okoliščinah (npr. v primeru polemik) od agencije EFSA zahteva, da naroči študije z namenom preverjanja.

en	Register of commissioned studies Development & run 0.160 0.280 0.400 0.400 0.400 1.640
sl	Register naročenih študij Razvoj in upravljanje 0,160 0,280 0,400 0,400 0,400 1,640

en	(35) For the purposes of ensuring transparency of the risk assessment process, it is also necessary to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also cover applications for authorisations in the context of Regulation (EC) No 1831/2003 as regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and Regulation (EC) No 1107/2009 as regards plant protection products.
sl	(35) Za zagotovitev preglednosti postopka ocenjevanja tveganja je prav tako treba razširiti področje uporabe Uredbe (ES) št. 178/2002, ki je trenutno omejeno na živilsko zakonodajo, da se vanj vključijo tudi zahtevki za dovoljenje v okviru Uredbe (ES) št. 1831/2003 v zvezi s krmnimi dodatki, vloge za odobritev v okviru Uredbe (ES) št. 1935/2004 v zvezi z materiali, namenjenimi za stik z živili, in vloge za registracijo v okviru Uredbe (ES) št. 1107/2009 v zvezi s fitofarmacevtskimi sredstvi.

en	In particular, the Authority should organise the preparatory work supporting the Panels' tasks, including by requesting the Authority's staff or national scientific organisations networking with the Authority to draft preparatory scientific opinions to be peer-reviewed and adopted by the Panels.
sl	Agencija bi zlasti morala organizirati pripravljalno delo v podporo nalogam, ki jih opravljajo znanstveni sveti, tudi tako, da od osebja Agencije ali nacionalnih znanstvenih organizacij, ki se povezujejo z Agencijo, zahteva, da pripravijo osnutek pripravljalnih znanstvenih mnenj, za katere bo opravljen medsebojni strokovni pregled in ki jih bodo sprejeli znanstveni sveti.

en	Estimated impact on EFSA revenue
sl	Ocenjene posledice za prihodke EFSA

en	4) develop a more effective and transparent risk communication with the public in collaboration with Member States]
sl	4) razviti učinkovitejše in preglednejše obveščanje javnosti o tveganju v sodelovanju z državami članicami.]

en	XThe proposal/initiative relates to an action redirected towards a new action
sl	XPredlog/pobuda se nanaša na obstoječ ukrep, preusmerjen v nov ukrep.

en	The general plan should identify the key factors that need to be taken into account when considering the type and level of communication activities needed, ascertain the tools and channels for the relevant risk communication initiatives taking into account the relevant target audience groups; and, establish appropriate mechanisms to ensure coherent risk communication.
sl	V splošnem načrtu bi bilo treba opredeliti ključne dejavnike, ki jih je treba upoštevati pri določanju vrste in ravni potrebnih dejavnosti obveščanja, opredeliti orodja in kanale za ustrezne pobude obveščanja o tveganju, pri čemer se upoštevajo zadevne ciljne skupine, in vzpostaviti ustrezne mehanizme za zagotovitev usklajenega obveščanja o tveganju.

en	Stakeholders engagement in RA process 12.5 FTES 0.646 1.131 1.615
sl	Sodelovanje zainteresiranih strani v postopku ocenjevanja tveganja 12,5 EPDČ 0,646 1,131 1,615

en	Regulation (EC) No 1107/2009 is amended as follows:
sl	Uredba (ES) št. 1107/2009 se spremeni:

en	Subtotal for specific objective No 2 6.000 10.500 15.000 15.000 15.000 61.500
sl	Seštevek za specifični cilj št. 2 6,000 10,500 15,000 15,000 15,000 61,500

en	4) Strengthen risk communication between the Commission/EFSA /Members States and public /stakeholders.
sl	4) Predlog bo okrepil obveščanje javnosti/zainteresiranih strani s strani Komisije/agencije EFSA/držav članic.

en	- during the evaluation phase of a call for proposals/tender, the proposers and tenderers are checked against the published exclusion criteria based on declarations and the Early Detection and Exclusion System (EDES);
sl	- preverjanje predlagateljev in ponudnikov glede na objavljena izločitvena merila na podlagi izjav ter sistema za zgodnje odkrivanje in izključitev med ocenjevalno fazo razpisa za zbiranje predlogov/ponudb;

en	Accordingly, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002.
sl	Zato je treba spremeniti Direktivo 2001/18/ES, Uredbo (ES) št. 1829/2003, Uredbo (ES) št. 1831/2003, Uredbo (ES) št. 1935/2004 in Uredbo (ES) št. 1107/2009, da se določijo dodatni zaupni elementi poleg tistih, ki so določeni v Uredbi (ES) št. 178/2002.

en	It is therefore appropriate that the studies planned for supporting requests for renewals should be notified by the applicant to the Authority and that following a consultation of third parties on these planned studies, the Authority systematically provides advice to the applicants on the content of the intended renewal application, taking into account the received comments.
sl	Iz tega razloga je primerno, da vlagatelj načrtovane študije v podporo vlogam za obnovitev odobritve priglasi Agenciji in da Agencija po posvetovanju s tretjimi osebami o teh načrtovanih študijah sistematično svetuje vlagateljem o vsebini predvidene vloge za obnovitev odobritve, ob upoštevanju prejetih pripomb.

en	[21: Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, (OJ L 31, 1.2.2002, p.
sl	[21: Uredba (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane (UL L 31, 1.2.2002, str.

en	First, it will establish a Union register of commissioned studies on substances subject to a food law authorisation system, to be managed by EFSA.
sl	S predlogom bo najprej vzpostavljen register Unije naročenih študij o snoveh, vključenih v sistem za odobritev v okviru živilske zakonodaje, ki ga bo upravljala EFSA.

en	AST Total
sl	AST skupaj

en	Controls
sl	Nadzor

en	Pre-submission meetings without PC 6.2 FTEs 176 dossiers & meetings 7 days/dossier 0.318 0.557 0.796
sl	Seje pred vložitvijo brez javnega posvetovanja 6,2 EPDČ 176 spisov in sej 7 dni/spis 0,318 0,557 0,796

en	A Union register of studies commissioned by business operators to obtain an authorisation under Union food law is hereby established.
sl	Vzpostavi se register študij Unije, ki so jih naročili nosilci dejavnosti, da bi pridobili odobritev na podlagi živilske zakonodaje Unije.

en	General plan for risk communication
sl	Splošni načrt obveščanja o tveganju

en	New indemnity regime panels experts 2520 panel members days year Tot.
sl	Nova shema zavarovanja odgovornosti za strokovnjake znanstvenih svetov 2520 članov svetov/št.

en	Stakeholders engagement in RA process 50 events/year 10 panels5event panel/y 0.600 1.050 1.500 1.500 1.500 6.150
sl	Sodelovanje zainteresiranih strani v postopku ocenjevanja tveganja 50 dogodkov/leto 10 svetov, 5 dogodkov/svet/leto 0,600 1,050 1,500 1,500 1,500 6,150

en	Should that be the case, the Authority shall follow the procedure laid down in Article 39b, which shall apply mutatis mutandis.
sl	V tem primeru ravna agencija v skladu s postopkom iz člena 39b, ki se uporablja smiselno.

en	4) develop a more effective and transparent risk communication with the public in collaboration with Member States
sl	4) Razviti učinkovitejše in preglednejše obveščanje javnosti o tveganju v sodelovanju z državami članicami

en	The Authority shall consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the Authority in accordance with Article 38 and Articles 39 to 39f in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation.
sl	Agencija se po objavi študij v podporo vlogam za odobritev v skladu s členom 38 in členi 39 do 39f o njih posvetuje z zainteresiranimi stranmi in javnostjo, da bi ugotovila, ali so na voljo drugi ustrezni znanstveni podatki ali študije o predmetu vloge za odobritev.

en	(4) In Article 28, the following paragraph 4 is added:
sl	(4) v členu 28 se doda naslednji odstavek 4:

en	As announced in the Communication replying to the European Citizens' Initiative "Ban glyphosate and protect people and the environment from toxic pesticides", this proposal is a targeted revision of the GFL Regulation (and other measures adopted in that framework) in order to improve transparency in risk assessment, reliability, objectivity and independence of studies used by EFSA in its risk assessment, risk communication, and governance of EFSA.
sl	Kot je Komisija napovedala v svojem sporočilu v odgovor na evropsko državljansko pobudo „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi", gre pri tem predlogu za ciljno revizijo uredbe o splošni živilski zakonodaji (in drugih ukrepov, sprejetih v navedenem okviru), da se izboljšajo preglednost v oceni tveganja, zanesljivost, objektivnost in neodvisnost študij, ki jih EFSA uporabi v svoji oceni tveganja, obveščanje o tveganju in upravljanje agencije EFSA.

en	- regular training on issues related to fraud and irregularities is given to all staff involved in contract management as well as to auditors and controllers who verify the beneficiaries' declarations on the spot.
sl	- vsi zaposleni, ki so vključeni v upravljanje pogodb, ter revizorji in nadzorniki, ki preverjajo izjave upravičencev na kraju samem, se redno izobražujejo o vprašanjih, povezanih z goljufijami in nepravilnostmi.

en	Preparatory work sharing with MSs grants/procurements 5.120 8.960 12.800 12.800 12.800 52.480
sl	Pripravljalno delo skupaj z DČ nepovratna sredstva/naročila 5,120 8,960 12,800 12,800 12,800 52,480

en	improve the governance of and strengthen the scientific cooperation of Member States with and their involvement in the EFSA;
sl	izboljšanja upravljanja agencije EFSA in krepitve znanstvenega sodelovanja držav članic z agencijo ter njihove vključenosti v delovanje agencije;

en	3) Better Involving Members States in EFSA's governance structure and Scientific Panels and thus support the sustainability in the long-term of EFSA risk assessment without touching on its independence.
sl	3) Predlog bo omogočil boljše vključevanje držav članic v strukturo upravljanja in znanstvene svete agencije EFSA, s čimer bo podpiral dolgoročno trajnost ocenjevanja tveganja agencije EFSA, ne da bi to vplivalo na njeno neodvisnost.

en	(c) in paragraph 3 the following point (m) is added:
sl	(c) v odstavku 3 se doda naslednja točka (m):

en	Regulation (EU) 2016/679 of the European Parliament and of the Council and Regulation (EC) No 45/2001 of the European Parliament and of the Council shall apply to the processing of personal data carried out pursuant to this Regulation.
sl	Za obdelavo osebnih podatkov v skladu s to uredbo se uporabljata Uredba (EU) 2016/679 Evropskega parlamenta in Sveta ter Uredba (ES) št. 45/2001 Evropskega parlamenta in Sveta.

en	"Article 61
sl	„Člen 61

en	Preparatory work sharing with MSs 6.9 FTEs 0.356 0.624 0.891
sl	Pripravljalno delo skupaj z DČ 6,9 EPDČ 0,356 0,624 0,891

en	(1) in Article 6, the following paragraph 5 is added:
sl	(1) v členu 6 se doda naslednji odstavek 5:

en	(i) inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them; and,
sl	(i) o vlogi nemudoma obvesti druge države članice in Komisijo ter jim da na voljo vlogo z vsemi morebitnimi dodatnimi informacijami, ki jih je predložil vlagatelj; ter

en	Current procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession.
sl	Sedanji postopki temeljijo na načelu, da mora vlagatelj dokazati, da na podlagi znanstvenih dognanj, ki so mu na voljo, predmet odobritvenega postopka izpolnjuje varnostne zahteve Unije.

en	day cost= 2549 1.408 2.464 3.520 3.520 3.520 14.432
sl	dni/leto Skupni dnevni stroški = 2549 1,408 2,464 3,520 3,520 3,520 14,432

en	Review of confidentiality
sl	Pregled zaupnosti

en	Regulation (EC) No 2065/2003 is amended as follows:
sl	Uredba (ES) št. 2065/2003 se spremeni:

en	In its Communication replying to the European Citizens' Initiative "Ban glyphosate and protect people and the environment from toxic pesticides", the Commission also announced the preparation of a legislative proposal "covering transparency in scientific assessments, quality and independence of the scientific studies that are the basis of the Union risk assessment carried out by EFSA and the governance of EFSA".
sl	Komisija je v svojem sporočilu v odgovor na evropsko državljansko pobudo „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi" napovedala tudi pripravo zakonodajnega predloga, ki zajema preglednost znanstvenih ocen, kakovost in neodvisnost znanstvenih študij, na katerih temelji ocena tveganja v Uniji, ki jo izvede EFSA, ter upravljanje agencije EFSA.

en	(d) The nominations by the Member States, the selection by the Executive Director and the appointments by the Management Board shall be made on the basis of the following criteria:
sl	(d) Na podlagi naslednjih meril države članice predlagajo strokovnjake, izvršni direktor jih izbere in upravni odbor imenuje:

en	It is therefore necessary to ensure a more comprehensive and continuous risk communication process throughout the risk analysis process, involving Union and national risk assessors and risk managers combined with open dialogue amongst all interested parties.
sl	Zato je treba zagotoviti bolj celovit in stalen postopek obveščanja o tveganju med celotnim postopkom analize tveganja, ki vključuje odgovorne za oceno tveganja in odgovorne za obvladovanje tveganja na ravni Unije in nacionalni ravni, skupaj z odprtim dialogom med vsemi zainteresiranimi stranmi.

en	Article 8
sl	Člen 8

en	3) improve the governance, strengthen the involvement of Member States and address the limitations affecting the long term scientific capacity of EFSA
sl	3) Izboljšati upravljanje, okrepiti vključenost držav članic ter odpraviti omejitve, ki vplivajo na dolgoročno znanstveno zmogljivost agencije EFSA

en	Direct management by the Commission through
sl	Neposredno upravljanje - Komisija:

en	The Commission acknowledged in its Communication in reply to the European Citizen's Initiative (ECI) "Ban glyphosate and protect people and environment from toxic pesticides" that "transparency in scientific assessments and decision-making is vital to ensuring consumers' confidence in the regulatory system.
sl	Komisija je v svojem sporočilu v odgovor na evropsko državljansko pobudo „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi" potrdila, da je „preglednost znanstvenih ocen in postopka odločanja bistvena za zaupanje v regulativni okvir".

en	(i) inform the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them; and,
sl	(i) o vlogi obvesti druge države članice in Komisijo ter jim da na voljo vlogo z vsemi dodatnimi informacijami, ki jih je predložil vlagatelj; ter

en	Subtotal for specific objective No 3 9.592 16.785 23.979 23.979 23.979 98.314
sl	Seštevek za specifični cilj št. 3 9,592 16,785 23,979 23,979 23,979 98,314

en	Function group IV
sl	Funkcionalna skupina IV

en	XX 01 02 02 (AC, AL, END, INT and JED in the Delegations)
sl	XX 01 02 02 (PU, LU, NNS, ZU in MSD na delegacijah)

en	(4) It is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers.
sl	(4) Zato je treba zagotoviti celovit in stalen postopek obveščanja o tveganju med celotnim postopkom analize tveganja, ki vključuje odgovorne za oceno tveganja in odgovorne za obvladovanje tveganja na ravni Unije in nacionalni ravni.

en	Directive (EC) No 2001/18/EC is amended as follows:
sl	Direktiva 2001/18/ES se spremeni:

en	(10) the following Article 57a is inserted after the title of Section 1 in Chapter V:
sl	(10) v poglavju V se pod naslov oddelka 1 vstavi naslednji člen 57a:

en	Regulation (EC) No 1935/2004 is amended as follows:
sl	Uredba (ES) št. 1935/2004 se spremeni:

en	Article 8c
sl	Člen 8c

en	The Authority shall ensure public access to the additional information supplied by the applicant in accordance with Articles 11 and 12.
sl	Agencija v skladu s členoma 11 in 12 zagotovi javni dostop do dodatnih informacij, ki jih je predložil predlagatelj.

en	Pre-submission meetings for all renewals with PC 4.3 FTEs 74applications 7 man-days+ 4 PC 0.220 0.385 0.550
sl	Seje pred vložitvijo za vse obnovitve z javnim posvetovanjem 4,3 EPDČ 74 vlog 7 delovnih dni + 4 javna posvetovanja 0,220 0,385 0,550

en	New indemnity regime working groups Tot.
sl	Nova shema zavarovanja odgovornosti za delovne skupine Skupno število strokovnjakov/št.

en	(2) in Article 15, at the end of paragraph 1 the following sentence is added:
sl	(2) v členu 15 se na koncu odstavka 1 doda naslednji stavek:

en	Regulation (EC) No 1331/2008 is amended as follows:
sl	Uredba (ES) št. 1331/2008 se spremeni:

en	Article 8a
sl	Člen 8a

en	"(c) ensure public access to the application and any information supplied by the applicant, in accordance with Article 18.
sl	„(c) v skladu s členom 18 zagotoviti javni dostop do zahtevka in vseh informacij, ki jih je predložil vložnik.

en	In accordance with the conditions and the procedures laid down in Articles 39 to 39f of Regulation (EC) No 178/2002 and this Article, the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification; and, the Authority shall assess the confidentiality request submitted by the applicant.
sl	V skladu s pogoji in postopki iz členov 39 do 39f Uredbe (ES) št. 178/2002 in tega člena lahko vložnik zahteva, da se nekatere informacije, predložene na podlagi te uredbe, obravnavajo zaupno, pri čemer priloži preverljivo utemeljitev; ter urad oceni zahtevo za zaupnost, ki jo je predložil vložnik.

en	Objectives of risk communication
sl	Cilji obveščanja o tveganju

en	(a) the notifier/applicant may request certain information submitted under this Directive to be kept confidential, accompanied by verifiable justification; and,
sl	(a) lahko prijavitelj/vlagatelj zahteva, da se nekatere informacije, predložene na podlagi te direktive, obravnavajo zaupno, pri čemer priloži preverljivo utemeljitev; ter

en	Function group II
sl	Funkcionalna skupina II

en	In accordance with the conditions and the procedures laid down in Article 39 of Regulation (EC) No 178/2002 and this article, the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification.
sl	V skladu s pogoji in postopki iz člena 39 Uredbe (ES) št. 178/2002 in tega člena lahko vlagatelj zahteva, da se nekatere informacije, predložene na podlagi te uredbe, obravnavajo zaupno, pri čemer priloži preverljivo utemeljitev.

en	AD Total
sl	AD skupaj

en	2023 2024 esq. (see point 1.6)
sl	2023 2024- (gl. točko 1.6)

en	"Article 25
sl	„Člen 25

en	[Heading………………………………] Diff./non-diff. from EFTA countries from candidate countries from third countries within the meaning of Article 21(2)(b) of the Financial Regulation
sl	držav Efte držav kandidatk tretjih držav po členu 21(2)(b) finančne uredbe

en	General principles of risk communication
sl	Splošna načela obveščanja o tveganju

en	"Article 32a
sl	„Člen 32a

en	Specific objective No
sl	Specifični cilji

en	It aligns the composition of EFSA's Management Board with the Common Approach on decentralized agencies by including representatives of all Member States.
sl	Sestavo upravnega odbora agencije EFSA usklajuje s skupnim pristopom k decentraliziranim agencijam, in sicer z vključitvijo predstavnikov vseh držav članic.

en	General advice
sl	Splošno mnenje

en	day cost= 2549 2.571 4.492 6.426 6.426 6.426 26.347
sl	delovnih dni = 4600 Skupni dnevni stroški = 2549 2,571 4,492 6,426 6,426 6,426 26,347

en	MB with MSs & observers 0.2 FTEs 0.010 0.018 0.025
sl	Upravni odbor z DČ in opazovalci 0,2 EPDČ 0,010 0,018 0,025

en	(b) the following paragraph 1a is inserted:
sl	(b) vstavi se naslednji odstavek 1a:

en	PC on all dossiers 8.5 FTEs 376dossiers for PC 0.5 effort/day+4 outcome 0.437 0.765 1.093
sl	javno posvetovanje o vseh spisih 8,5 EPDČ 376 spisov za javno posvetovanje 0,5 dneva (javno posvetovanje) + 4 dni za rezultat 0,437 0,765 1,093

en	Function group I
sl	Funkcionalna skupina I

en	(9) in Article 41, the following sentence is added at the end of paragraph 1:
sl	(9) v členu 41 se na koncu odstavka 1 doda naslednji stavek:

en	"Article 30
sl	„Člen 30

en	[40: Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p.
sl	[40: Uredba (ES) št. 1367/2006 Evropskega parlamenta in Sveta z dne 6. septembra 2006 o uporabi določb Aarhuške konvencije o dostopu do informacij, udeležbi javnosti pri odločanju in dostopu do pravnega varstva v okoljskih zadevah v institucijah in organih Skupnosti (UL L 264, 25.9.2006, str.

en	[22: Commission Staff Working Document, "The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002)", SWD(2018)38 final, dated 15.1.2018.]
sl	[22: Delovni dokument služb Komisije „The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002)" („Ocena splošne živilske zakonodaje (Uredbe (ES) št. 178/2002) v okviru programa REFIT"), SWD(2018) 38 final, z dne 15. januarja 2018.]

en	"Article 39a
sl	„Člen 39a

en	(5) in Article 63, paragraphs 1 and 2 are replaced by the following:
sl	(5) v členu 63 se odstavka 1 in 2 nadomestita z naslednjim:

en	Estimated impact on [body]'s appropriations
sl	Ocenjene posledice za odobritve [organa]

en	[3: Commission Staff Working Document, "The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002)", SWD (2018)38 final, dated 15.1.2018.]
sl	[3: Delovni dokument služb Komisije, The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002) („Ocena splošne živilske zakonodaje (Uredbe (ES) št. 178/2002) v okviru programa REFIT"), SWD(2018) 38 final, z dne 15. januarja 2018.]

en	Article 5
sl	Člen 5

en	Estimated impact on [body]'s human resources
sl	Ocenjene posledice za človeške vire [organa]

en	2) increase the guarantees of reliability, objectivity and independence of studies used by EFSA in its risk assessment, in particular in the framework of authorisation applications;
sl	2) povečati jamstva glede zanesljivosti, objektivnosti in neodvisnosti študij, ki jih EFSA uporabi v svojih ocenah tveganja, zlasti v okviru vlog za odobritev;

en	It is also essential to this end that the Executive Director whose function is to defend EFSA's interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts.
sl	Zato je prav tako nujno, da je v izbor in imenovanje navedenih znanstvenih strokovnjakov vključen tudi izvršni direktor, katerega naloga je ščititi interese Agencije in zlasti neodvisnost njenega strokovnega znanja.

en	It aligns the composition of EFSA's Management Board with the Common Approach on Union decentralised agencies by including representatives of all Member States.
sl	Sestavo upravnega odbora agencije EFSA usklajuje s skupnim pristopom k decentraliziranim agencijam Unije, in sicer z vključitvijo predstavnikov vseh držav članic.

en	(2) In Article 13, the following paragraph 2a is inserted:
sl	(2) v člen 13 se vstavi naslednji odstavek 2a:

en	(9) in Article 29, paragraphs 1 and 2 are replaced by the following:
sl	(9) v členu 29 se odstavka 1 in 2 nadomestita z naslednjim:

en	"The Authority shall ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant in accordance with Article 23.
sl	„Agencija v skladu s členom 23 zagotovi javni dostop do vloge, zadevnih podpornih informacij in vseh dodatnih informacij, ki jih je predložil vložnik.

en	In the case of renewals, the pre-submission procedure foresees that studies planned by a potential applicant will have to be notified to EFSA and, after consultation of third parties on these planned studies, the Authority will systematically provide advice to the applicants.
sl	V primeru obnovitev postopek pred vložitvijo vloge določa, da je študije, ki jih načrtuje morebitni vlagatelj, treba priglasiti agenciji EFSA, po posvetovanju s tretjimi osebami o teh načrtovanih študijah pa EFSA sistematično svetuje vlagateljem.

en	"Article 15
sl	„Člen 15

en	Article 8b
sl	Člen 8b

en	[5: Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p.
sl	[5: Direktiva 2001/18/ES Evropskega parlamenta in Sveta z dne 12. marca 2001 o namernem sproščanju gensko spremenjenih organizmov v okolje in razveljavitvi Direktive Sveta 90/220/EGS (UL L 106, 17.4.2001, str.

en	][33: Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p.
sl	][33: Uredba (ES) št. 1331/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila (UL L 354, 31.12.2008, str.

en	"The Authority shall publish detailed guidance, following the agreement with the Commission, concerning the preparation and the submission of the application, referred to in paragraph (1), taking into account standard data formats, where they exist in accordance with Article 39f of Regulation (EC) No 178/2002.
sl	„Agencija po dogovoru s Komisijo objavi natančna navodila glede priprave in vložitve vloge iz odstavka (1), ob upoštevanju standardnih oblik zapisa podatkov, če te obstajajo, v skladu s členom 39f Uredbe (ES) št.

en	In the case of renewals, the pre-submission procedure foresees that studies planned by a potential applicant will have to be notified to EFSA and, after public consultation on these planned studies, the Authority will systematically provide advice to the applicants.
sl	V primeru obnovitev postopek pred vložitvijo vloge predvideva, da je o študijah, ki jih načrtuje morebitni vlagatelj, treba obvestiti agencijo EFSA in da po javnem posvetovanju o teh načrtovanih študijah EFSA sistematično svetuje vlagateljem.

en	"Article 23
sl	„Člen 23

en	(c) paragraph 9(b) is replaced by the following:
sl	(c) odstavek 9(b) se nadomesti z naslednjim:

en	The advice provided by the staff of the Authority shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels.
sl	Mnenje, ki ga poda osebje agencije, ne posega v naknadne ocene vlog za odobritev, ki jih pripravijo znanstveni sveti, ter zanje ni zavezujoče.

en	][35: Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p.
sl	][35: Uredba (EU) 2015/2283 Evropskega parlamenta in Sveta z dne 25. novembra 2015 o novih živilih, spremembi Uredbe (EU) št. 1169/2011 Evropskega parlamenta in Sveta in razveljavitvi Uredbe (ES) št. 258/97 Evropskega parlamenta in Sveta ter Uredbe Komisije (ES) št. 1852/2001 (UL L 327, 11.12.2015, str.

en	[28: Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p.
sl	[28: Direktiva 2001/18/ES Evropskega parlamenta in Sveta z dne 12. marca 2001 o namernem sproščanju gensko spremenjenih organizmov v okolje in razveljavitvi Direktive Sveta 90/220/EGS (UL L 106, 17.4.2001, str.

en	[38: Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), (OJ L 119, 4.5.2016, p.
sl	[38: Uredba (EU) 2016/679 Evropskega parlamenta in Sveta z dne 27. aprila 2016 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov ter o razveljavitvi Direktive 95/46/ES (Splošna uredba o varstvu podatkov) (UL L 119, 4.5.2016, str.

en	][26: Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p.
sl	][26: Uredba (EU) 2016/679 Evropskega parlamenta in Sveta z dne 27. aprila 2016 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov ter o razveljavitvi Direktive 95/46/ES (Splošna uredba o varstvu podatkov) (UL L 119, 4.5.2016, str.

en	increase the guarantees of reliability, objectivity and independence of studies the EFSA uses in its risk assessment, in particular in the context of authorisation applications;
sl	povečanja jamstev glede zanesljivosti, objektivnosti in neodvisnosti študij, ki jih EFSA uporabi v svoji oceni tveganja, zlasti v okviru vlog za odobritev;

en	Function group III
sl	Funkcionalna skupina III

en	TOTAL 5.490 9.608 13.726 13.726 13.726 56.276
sl	SKUPAJ 5,490 9,608 13,726 13,726 13,726 56,276

en	Article 11
sl	Člen 11

en	"Article 16
sl	„Člen 16

en	[36: Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p.13).]
sl	[36: Uredba (ES) št. 1367/2006 Evropskega parlamenta in Sveta z dne 6. septembra 2006 o uporabi določb Aarhuške konvencije o dostopu do informacij, udeležbi javnosti pri odločanju in dostopu do pravnega varstva v okoljskih zadevah v institucijah in organih Skupnosti (UL L 264, 25.9.2006, str.

en	Title 1: Staff expenditure Commitments (1) 5.490 9.608 13.726 13.726 13.726 56.276
sl	Naslov 1: Odhodki za zaposlene obveznosti (1) 5,490 9,608 13,726 13,726 13,726 56,276

en	Appeals 8.4 FTEs 450/ dossier10% =45 appeals 10% confid.
sl	Pritožbe 8,4 EPDČ 450 spisov, 10 % =45 pritožb 10 % zahtev za zaup./spis 0,432 0,757 1,081

en	It shall:
sl	V njem so:

en	][10: Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p.
sl	][10: Uredba (ES) št. 1331/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila (UL L 354, 31.12.2008, str.

en	(5) Article 38 is amended as follows:
sl	(5) člen 38 se spremeni:

en	The separation of risk management and risk assessment, with the newly created EFSA responsible for risk assessment, was the single biggest innovation in the GFL Regulation.
sl	Edina velika novost v uredbi o splošni živilski zakonodaji je bila ločitev obvladovanja tveganja od ocene tveganja, za katero je postala odgovorna novoustanovljena agencija EFSA.

en	Article 39f
sl	Člen 39f

en	Where the Commission requests its opinion in accordance with Articles 10(3) and 16 of this Regulation, the Authority shall assess the confidentiality request submitted by the applicant, in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002.
sl	Kadar Komisija v skladu s členom 10(3) in členom 16 te uredbe zaprosi za mnenje Agencije, Agencija oceni zahtevo za zaupnost, ki jo je vložil vložnik, v skladu s členi 39 do 39e Uredbe (ES) št. 178/2002.

en	][31: Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (OJ L 309, 26.11.2003, p.
sl	][31: Uredba (ES) št. 2065/2003 Evropskega parlamenta in Sveta z dne 10. novembra 2003 o aromah dima, ki se uporabljajo ali so namenjene uporabi v ali na živilih (UL L 309, 26.11.2003, str.

en	day cost= 1.152 0.221 0.387 0.553 0.553 0.553 2.267
sl	21 članov sveta 10 svetov x 6 sej/leto Skupni dnevni stroški = 1,152 0,221 0,387 0,553 0,553 0,553 2,267

en	(c) inform the applicant in writing of its intention to disclose information and the reasons for it, before the Authority formally takes a decision on the confidentiality request.
sl	(c) preden sprejme uradno odločitev o zahtevi za zaupnost, pisno obvesti vlagatelja o svoji nameri, da razkrije informacije, in navede razloge zanjo.

en	][12: Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p.
sl	][12: Uredba (EU) 2015/2283 Evropskega parlamenta in Sveta z dne 25. novembra 2015 o novih živilih, spremembi Uredbe (EU) št. 1169/2011 Evropskega parlamenta in Sveta in razveljavitvi Uredbe (ES) št. 258/97 Evropskega parlamenta in Sveta ter Uredbe Komisije (ES) št. 1852/2001 (UL L 327, 11.12.2015, str.

en	(1) in Chapter II the following SECTION 1a is inserted:
sl	(1) v poglavje II se vstavi naslednji ODDELEK Ia:

en	"Article 20
sl	„Člen 20

en	(6) Article 39 is replaced by the following:
sl	(6) člen 39 se nadomesti z naslednjim:

en	(34) In order to ensure consistency with the proposed adaptations in Regulation (EC) No 178/2002, provisions relating to public access and the protection of confidential information in Directive 2001/18/EC of the European Parliament and of the Council, Regulation (EC) No 1829/2003 of the European Parliament and of the Council, in Regulation (EC) No 1831/2003 of the European Parliament and of the Council, in Regulation (EC) No 2065/2003 of the European Parliament and of the Council, in Regulation (EC) No 1935/2004 of the European Parliament and of the Council, in Regulation (EC) No 1331/2008 of the European Parliament and of the Council, in Regulation (EC) No 1107/2009 of the European Parliament and of the Council and in Regulation (EU) 2015/2283 of the European Parliament and of the Council should be amended.
sl	(34) Da bi zagotovili skladnost s predlaganimi prilagoditvami Uredbe (ES) št. 178/2002, bi bilo treba spremeniti določbe v zvezi z javnim dostopom in varstvom zaupnih informacij iz Direktive 2001/18/ES Evropskega parlamenta in Sveta, Uredbe (ES) št. 1829/2003 Evropskega parlamenta in Sveta, Uredbe Evropskega parlamenta in Sveta (ES) št. 1831/2003, Uredbe (ES) št. 2065/2003 Evropskega parlamenta in Sveta, Uredbe Evropskega parlamenta in Sveta (ES) št. 1935/2004, Uredbe (ES) št. 1331/2008 Evropskega parlamenta in Sveta, Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta ter Uredbe (EU) 2015/2283 Evropskega parlamenta in Sveta.

en	"Article 12
sl	„Člen 12

en	The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of the applications for renewal of authorisation by the Scientific Panels.
sl	Mnenje, ki ga poda agencija, ne posega v naknadne ocene vlog za obnovitev odobritve, ki jih pripravijo znanstveni sveti, ter zanje ni zavezujoče.

en	(1) In Article 6, the following paragraph 2a is inserted:
sl	(1) v člen 6 se vstavi naslednji odstavek 2a:

en	Article 9
sl	Člen 9

en	Strengthen advocacy: targeted messages, narrative, translations, etc Increase targeted communication key topics Sc.literacy actions 1.700 2.975 4.250 4.250 4.250 17.425
sl	Povečanje ciljnega sporočanja o glavnih temah Ukrepi glede znanstvene pismenosti 1,700 2,975 4,250 4,250 4,250 17,425

en	Article 32c
sl	Člen 32c

en	Confidentiality checks 25.2 FTEs 12.600studies 450 dossiers 80%confid.studies 0.4day scrutiny Average No studies /dossier= 35 1.302 2.279 3.256
sl	študij, 0,4 dneva pregled/študijo povprečno št. študij/spis = 35 1,302 2,279 3,256

en	"Article 10
sl	„Člen 10

en	(b) the following sentence is added at the end of the second paragraph:
sl	(b) na koncu drugega odstavka se doda naslednji stavek:

en	(5) Article 17 is amended as follows:
sl	(5) člen 17 se spremeni:

en	SPECIFIC OBJECTIVE No 2 .
sl	Specifični cilj št.

en	The applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification, upon submission of the application.
sl	Predlagatelj lahko zahteva, da se nekatere informacije, predložene na podlagi te uredbe, obravnavajo zaupno, pri čemer ob vložitvi zahtevka priloži preverljivo utemeljitev.

en	Regulation (EC) No 178/2002 is amended as follows:
sl	Uredba (ES) št. 178/2002 se spremeni:

en	(8) in Article 40, the second subparagraph of paragraph 3 is replaced by the following:
sl	(8) v členu 40 se drugi pododstavek odstavka 3 nadomesti z naslednjim:

en	Regulation (EC) No 1829/2003 is amended as follows:
sl	Uredba (ES) št. 1829/2003 se spremeni:

en	Article 10
sl	Člen 10

en	Title 3: Operational expenditure Commitments (3a) 19.512 34.145 48.779 48.779 48.779 199.994
sl	Naslov 3: Odhodki iz poslovanja obveznosti (3 a) 19,512 34,145 48,779 48,779 48,779 199,994

en	(a) the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification; and,
sl	(a) lahko vlagatelj zahteva, da se nekatere informacije, predložene na podlagi te uredbe, obravnavajo zaupno, pri čemer priloži preverljivo utemeljitev; ter

en	An application for an authorisation as provided for in Article 4 shall be sent to the Commission, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.
sl	Zahtevek za dovoljenje, kakor je določen v členu 4, se pošlje Komisiji v standardnih oblikah zapisa podatkov, če te obstajajo, v skladu s členom 39f Uredbe (ES) št. 178/2002, ki se uporablja smiselno.

en	][8: Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (OJ L 309, 26.11.2003, p.
sl	][8: Uredba (ES) št. 2065/2003 Evropskega parlamenta in Sveta z dne 10. novembra 2003 o aromah dima, ki se uporabljajo ali so namenjene uporabi v ali na živilih (UL L 309, 26.11.2003, str.

en	Where an opinion by the Authority is required in accordance with Article 3(2) of this Regulation, the Authority shall assess the confidentiality request submitted by the applicant, in accordance with Articles 39 to 39f of Regulation (EC) No 178/2002.
sl	Kadar Komisija v skladu s členom 3(2) te uredbe zaprosi za mnenje Agencije, Agencija oceni zahtevo za zaupnost, ki jo je vložil predlagatelj, v skladu s členi 39 do 39f Uredbe (ES) št. 178/2002.

en	(11) Article 61 is replaced by the following:
sl	(11) člen 61 se nadomesti z naslednjim:

en	X The proposal/initiative requires the use of operational appropriations, as explained below:
sl	X Za predlog/pobudo so potrebne odobritve za poslovanje, kot je pojasnjeno v nadaljevanju:

en	Extensive consultation and data collection (including external studies, extensive surveys, case studies and workshops as well as in-depth interviews with relevant stakeholders) has taken place on the issues this proposal addresses in the context of the GFL Fitness Check.
sl	V zvezi z vprašanji, zajetimi v tem predlogu, je v okviru preverjanja ustreznosti splošne živilske zakonodaje potekalo obsežno posvetovanje in zbiranje podatkov (vključno z zunanjimi študijami, obsežnimi raziskavami, študijami primerov in delavnicami ter poglobljenimi razgovori z zadevnimi zainteresiranimi stranmi).

en	for [body] <EFSA.> Commitments =1+1a +3a 25.002 43.753 62.505 62.505 62.505 256.270
sl	[organ] <EFSA.> SKUPAJ obveznosti =1+1a+3a 25,002 43,753 62,505 62,505 62,505 256,270

en	Payments (3b) 19.512 34.145 48.779 48.779 48.779 199.994
sl	plačila (3b) 19,512 34,145 48,779 48,779 48,779 199,994

en	The Authority shall assess, without delay, any request for confidentiality and make available to the public the information provided by the applicant under Article 15 as well as any other supplementary information submitted by the applicant, except for information in respect of which confidential treatment has been requested and accepted by the Authority pursuant to Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 178/2002, which shall apply mutatis mutandis and pursuant to Article 63 of this Regulation.
sl	Agencija nemudoma oceni vsako zahtevo za zaupnost in da na voljo javnosti informacije, ki jih je predložil vlagatelj na podlagi člena 15, vključno z vsemi dodatnimi informacijami, ki jih je predložil vlagatelj, razen informacij, za katere je bila zahtevana zaupna obravnava, ki jo je Agencija tudi odobrila, v skladu s členom 38, členi 39 do 39f in členom 40 Uredbe (ES) št. 178/2002, ki se uporabljajo smiselno, ter v skladu s členom 63 te uredbe.

en	"Article 18
sl	„Člen 18

en	The Authority shall issue and publish detailed guidelines, following agreement with the Commission, concerning the preparation and the submission of the application, taking into account standard data formats, where they exist in accordance with Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.
sl	„Agencija po dogovoru s Komisijo izda in objavi podrobne smernice za pripravo in vložitev vloge, ob upoštevanju standardnih oblik zapisa podatkov, če te obstajajo, v skladu s členom 39f Uredbe (ES) št. 178/2002, ki se uporablja smiselno.

en	][11: Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p.
sl	][11: Uredba (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS (UL L 309, 24.11.2009, str.

en	on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283 [on novel foods]
sl	o preglednosti in trajnosti ocenjevanja tveganja v prehranski verigi v EU ter o spremembah Uredbe (ES) št. 178/2002 [o splošni živilski zakonodaji], Direktive 2001/18/ES [o namernem sproščanju gensko spremenjenih organizmov v okolje], Uredbe (ES) št. 1829/2003 [o gensko spremenjenih živilih in krmi], Uredbe (ES) št. 1831/2003 [o krmnih dodatkih], Uredbe (ES) št. 2065/2003 [o aromah dima], Uredbe (ES) št. 1935/2004 [o materialih, namenjenih za stik z živili], Uredbe (ES) št. 1331/2008 [o skupnem postopku odobritve za aditive za živila, encime za živila in arome za živila], Uredbe (ES) št. 1107/2009 [o fitofarmacevtskih sredstvih] in Uredbe (EU) 2015/2283 [o novih živilih]

en	Payments (2) 5.490 9.608 13.726 13.726 13.726 56.276
sl	plačila (2) 5,490 9,608 13,726 13,726 13,726 56,276

en	risk communication
sl	Obveščanje o tveganju

en	Article 39g
sl	Člen 39g

en	][34: Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p.
sl	][34: Uredba (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS (UL L 309, 24.11.2009, str.

en	Article 39d
sl	Člen 39d

en	(8) in Article 23, the introductory sentence of paragraph 2 is replaced by the following:
sl	(8) v členu 23 se uvodni stavek odstavka 2 nadomesti z naslednjim:

en	][32: Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p.
sl	][32: Uredba Evropskega parlamenta in Sveta (ES) št. 1935/2004 z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili, in o razveljavitvi direktiv 80/590/EGS in 89/109/EGS (UL L 338, 13.11.2004, str.

en	The impact for innovation (divulging business strategy) is not significant for the notification of planned studies in case of renewals since the substance is already known and the date of renewal is set up in legislation The pre-submission procedure will help the SME's access to innovation and is at the request of the applicant except for renewals which represent a specific case and a limited number of applications.
sl	Postopek pred vložitvijo vloge bo MSP olajšal dostop do inovacij in se uvede na zahtevo vlagatelja, razen za obnovitve, ki so poseben primer in zadevajo omejeno število vlog.

en	Article 32b
sl	Člen 32b

en	Article 32e
sl	Člen 32e

en	Article 39e
sl	Člen 39e

en	"(l) an identification of the parts of the application and any other supplementary information that the applicant requests to be kept confidential, accompanied by verifiable justification, pursuant to Articles 30 of this Regulation and Article 39 of Regulation (EC) No 178/2002; ";
sl	„(l) opredelitev delov vloge in vseh drugih dodatnih informacij, za katere vlagatelj v skladu s členom 30 te uredbe in členom 39 Uredbe (ES) št. 178/2002 zahteva, da se obravnavajo zaupno, pri čemer priloži preverljivo utemeljitev; ";

en	Proposal for a Regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283 [on novel foods.
sl	Predlog Uredbe Evropskega parlamenta in Sveta o preglednosti in trajnosti ocenjevanja tveganja v prehranski verigi v EU ter o spremembah Uredbe (ES) št. 178/2002 [o splošni živilski zakonodaji], Direktive 2001/18/ES [o namernem sproščanju gensko spremenjenih organizmov v okolje], Uredbe (ES) št. 1829/2003 [o gensko spremenjenih živilih in krmi], Uredbe (ES) št. 1831/2003 [o krmnih dodatkih], Uredbe (ES) št. 2065/2003 [o aromah dima], Uredbe (ES) št. 1935/2004 [o materialih, namenjenih za stik z živili], Uredbe (ES) št. 1331/2008 [o skupnem postopku odobritve za aditive za živila, encime za živila in arome za živila], Uredbe (ES) št. 1107/2009 [o fitofarmacevtskih sredstvih] in Uredbe (EU) 2015/2283 [o novih živilih].

en	Article 32d
sl	Člen 32d

en	executive agencies
sl	prek izvajalskih agencij.

en	TOTAL COST 19.512 34.145 48.779 48.779 48.779 199.994
sl	STROŠKI SKUPAJ 19,512 34,145 48,779 48,779 48,779 199,994

en	(6) in Article 18, paragraph 7 is replaced by the following:
sl	(6) v členu 18 se odstavek 7 nadomesti z naslednjim:

en	][9: Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p.
sl	][9: Uredba Evropskega parlamenta in Sveta (ES) št. 1935/2004 z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili, in o razveljavitvi direktiv 80/590/EGS in 89/109/EGS (UL L 338, 13.11.2004, str.

en	increase the guarantees of reliability, objectivity and independence of studies used by EFSA in its risk assessment for authorisation purposes
sl	SPECIFIČNI CILJ št. 2 povečati jamstva glede zanesljivosti, objektivnosti in neodvisnosti študij, ki jih EFSA uporabi v svojih ocenah tveganja za namene odobritve

en	(4) in Article 11(2), the introductory sentence is replaced by the following:
sl	(4) v členu 11(2) se uvodni stavek nadomesti z naslednjim:

en	Regulation (EC) No 1831/2003 is amended as follows:
sl	Uredba (ES) št. 1831/2003 se spremeni:

en	(a) in paragraph 3 the introductory sentence is replaced by the following:
sl	(a) v odstavku 3 se uvodni stavek nadomesti z naslednjim:

en	Article 39c
sl	Člen 39c

en	Article 7
sl	Člen 7

en	(2) in Article 6, paragraph 7 is replaced by the following:
sl	(2) v členu 6 se odstavek 7 nadomesti z naslednjim:

en	(d) the second subparagraph of paragraph 5 is replaced by the following:
sl	(d) drugi pododstavek odstavka 5 se nadomesti z naslednjim:

en	Article 39b
sl	Člen 39b

en	For consistency, the Commission proposal would also amend other sectoral food legislation.
sl	Zaradi skladnosti bi predlog Komisije spremenil tudi drugo sektorsko živilsko zakonodajo.

en	Targeted consultations with specific stakeholder groups also took place.
sl	Opravljena so bila tudi ciljno usmerjena posvetovanja s posebnimi skupinami zainteresiranih strani.

en	They also highlighted the need to ensure that the Commission proposal strengthens these elements while safeguarding the principles on which the EU food safety system is based.
sl	Poudarili so tudi potrebo po zagotovitvi, da predlog Komisije okrepi te elemente in hkrati ohrani načela, na katerih temelji sistem EU za varnost hrane.

en	Capacity for more public resources to finance studies on food safety.
sl	Zmogljivost za več javnih sredstev za financiranje študij o varnosti hrane.

en	Some MS expressed reservations on the potential added value of this measure.
sl	Nekatere države članice so izrazile zadržke glede možne dodane vrednosti tega ukrepa.

en	Scientific independence and excellence of experts are cornerstones of the EU risk assessment system.
sl	Znanstvena neodvisnost in odličnost strokovnjakov sta temelja sistema EU za ocenjevanje tveganja.

en	Sustainability of the risk assessment system and involvement of MS
sl	Trajnost sistema ocenjevanja tveganja in vključenost držav članic

en	Need to ensure the protection of confidential data and personal data.
sl	Potreba po zagotovitvi varstva zaupnih podatkov in varstva osebnih podatkov.

en	The information that EFSA makes public on its activities and contributions was also judged as very important.
sl	Tudi informacije, ki jih EFSA objavi o svojih dejavnostih in prispevkih, so bile ocenjene kot zelo pomembne.

en	Risk communication on food safety can be further strengthened by improving coordination and involving relevant stakeholders.
sl	Obveščanje o tveganju glede varnosti hrane je mogoče dodatno okrepiti z izboljšanjem usklajevanja in vključitvijo zadevnih zainteresiranih strani.

en	The Commission proposal would amend Regulation (EC) No 178/2002 which sets out the general principles and requirements of food law, establishing the European Food Safety Authority (EFSA) and defines procedures in matters of food safety.
sl	Predlog Komisije bi spremenil Uredbo (ES) št. 178/2002, ki določa splošna načela in zahteve živilske zakonodaje, ustanavlja Evropsko agencijo za varnost hrane (EFSA) in določa postopke, ki zadevajo varnost hrane.

en	18 of the stakeholders had also provided feedback on the roadmap.
sl	18 zainteresiranih strani je prav tako podalo povratne informacije o časovnem načrtu.

en	Safeguarding confidentiality and intellectual property rights is fundamental in order to avoid hampering innovation and competitiveness.
sl	Zagotavljanje zaupnosti in varovanje pravic intelektualne lastnine sta bistvenega pomena za izogibanje oviram za inovacije in konkurenčnost.

en	There was a similar response from the stakeholder group.
sl	Odziv skupine zainteresiranih strani je bil podoben.

en	Feedback received during the consultations was not taken into account if it went beyond the scope of the Commission proposal.
sl	Povratne informacije, prejete med posvetovanji, niso bile upoštevane, če so presegale področje uporabe predloga Komisije.

en	The contributions to the different consultations showed a need to consider the following when preparing the Commission proposal:
sl	Prispevki v okviru različnih posvetovanj so pokazali, da je treba pri pripravi predloga Komisije upoštevati naslednje:

en	MS acknowledged the need for more coordination among all actors.
sl	Države članice so potrdile potrebo po večji usklajenosti vseh akterjev.

en	The latter also highlighted the need to ensure the independence of EFSA's scientific processes.
sl	Slednji so prav tako poudarili potrebo po zagotavljanju neodvisnosti znanstvenih postopkov agencije EFSA.

en	The latter also highlighted the potential negative impact on competitiveness and innovation, in particular on new substances due to risks relating to potential unfair use of disclosed data and concerns over intellectual property rights.
sl	Slednji so prav tako poudarili morebiten negativni učinek na konkurenčnost in inovacije, zlasti na nove snovi, zaradi tveganj v zvezi z morebitno nepošteno uporabo razkritih podatkov in pomislekov glede pravic intelektualne lastnine.

en	The earlier the access to industry studies in the risk assessment process, the greater its impact on transparency.
sl	Čim hitrejši je dostop do študij industrije v postopku ocenjevanja tveganja, tem večji je njegov učinek na preglednost.

en	Industry stakeholders also highlighted the need to avoid unfair use of commercial data.
sl	Zainteresirane strani iz industrije so prav tako poudarile potrebo po preprečevanju nepoštene uporabe poslovnih podatkov.

en	Evidence from industry studies
sl	Dokazi iz študij industrije

en	Conclusions
sl	Sklepi

en	The Commission proposal builds on the findings of the Fitness Check of the General Food Law and follows the Commission Communication on the European Citizens' Initiative to "Ban glyphosate and protect people and the environment from toxic pesticides".
sl	Predlog Komisije temelji na ugotovitvah preverjanja ustreznosti splošne živilske zakonodaje in sledi sporočilu Komisije o evropski državljanski pobudi z naslovom „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi".

en	Regarding the establishment of a register of industry studies, mainly MS authorities highlighted the challenges as regards applicability outside the EU.
sl	Kar zadeva vzpostavitev registra študij industrije, so predvsem organi držav članic poudarili izzive glede uporabe zunaj EU.

en	Consultations also took place via the EFSA Advisory Forum (national food safety authorities) and the Commission Expert Group on General Food Law and with the Scientific Committee of EFSA.
sl	Opravljena so bila tudi posvetovanja v okviru posvetovalnega foruma agencije EFSA (z nacionalnimi organi za varnost hrane) in strokovne skupine Komisije o splošni živilski zakonodaji ter z znanstvenim odborom agencije EFSA.

en	Transparency of industry studies
sl	Preglednost študij industrije

en	A letter of the European Ombudsman to the President of the European Commission on ensuring the EU risk assessment model in the food chain is independent, transparent, and allows for meaningful stakeholder engagement, was also considered.
sl	Upoštevano je bilo tudi pismo evropskega varuha človekovih pravic predsedniku Evropske komisije o zagotavljanju modela EU za ocenjevanje tveganja v prehranski verigi, ki je neodvisen, pregleden in omogoča smiselno sodelovanje zainteresiranih strani.

en	Some citizens highlighted the need to avoid complexity and/or confusion in risk communication, and recommended making it clearer and simpler.
sl	Nekateri državljani so poudarili, da se je treba izogniti zapletenosti in/ali zmedi v zvezi z obveščanjem o tveganju, in predlagali, da postane jasnejše in enostavnejše.

en	This was followed by an open public consultation (OPC), targeting citizens and stakeholders, open from 23 January 2018 to 20 March 2018.
sl	Temu je sledilo odprto javno posvetovanje z državljani in zainteresiranimi stranmi, ki je potekalo od 23. januarja 2018 do 20. marca 2018.

en	This report covers feedback from citizens and national authorities, groups and organisations (‘stakeholders') as regards the initiative for a Commission proposal for a Regulation on the transparency and sustainability of the EU risk assessment in the food chain (‘Commission proposal').
sl	To poročilo zajema povratne informacije državljanov in nacionalnih organov ter skupin in organizacij („zainteresirane strani") v zvezi s pobudo o predlogu Komisije za uredbo o preglednosti in trajnosti ocenjevanja tveganja v prehranski verigi v EU („predlog Komisije").

en	Industry organisations commented that there is a risk of the published data being misuse.
sl	Industrijske organizacije so pripomnile, da obstaja tveganje zlorabe objavljenih podatkov.

en	As regards the financing of these verification studies, a small percentage of both citizens and stakeholders considered that the costs should be covered by the individual applicant concerned.
sl	Glede financiranja teh preveritvenih študij je majhen delež sodelujočih državljanov in zainteresiranih strani menil, da bi stroške moral kriti posamezni vlagatelj.

en	Although, in general, stakeholders showed similar views, some saw certain measures as having different levels of importance.
sl	Čeprav so v splošnem zainteresirane skupine izrazile podobna stališča, so se določeni ukrepi nekaterim zdeli različno pomembni.

en	EU-level stakeholder organisations representing farmers, cooperatives, the food industry, retailers, consumers, professionals and civil society were consulted in a working group meeting of the Advisory Group on the Food Chain and Animal and Plant Health.
sl	Posvetovanja z organizacijami zainteresiranih strani na ravni EU, ki zastopajo kmete, zadruge, živilsko industrijo, trgovce na drobno, potrošnike, strokovnjake in civilno družbo, so potekala na sestanku svetovalne skupine za prehranjevalno verigo ter zdravje živali in rastlin.

en	[4: https://ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-chain_en ]
sl	[4: https://ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-chain_sl. ]

en	Risk Communication
sl	Obveščanje o tveganju

en	MS authorities also considered the importance of defining clear roles for the Management Board to avoid duplication with EFSA's Advisory Forum.
sl	Organi držav članic so omenili tudi pomembnost določitve jasnih nalog upravnega odbora, da bi se izognili podvajanju dela s posvetovalnim forumom agencije EFSA.

en	As regards the citizens who took part, 318 replies came from 26 MS, 10 came from a European Free Trade Association country and five from other non-EU countries.
sl	Kar zadeva državljane, ki so sodelovali v posvetovanju, pa je bilo prejetih 318 odgovorov iz 26 držav članic, 10 odgovorov iz držav Evropskega združenja za prosto trgovino in pet odgovorov iz drugih držav, ki niso članice EU.

en	Some NGOs and EFSA's Scientific Committee supported the added value of more public resources dedicated to food safety studies.
sl	Nekatere nevladne organizacije in znanstveni odbor agencije EFSA so podprli dodano vrednost dodelitve več javnih sredstev za študije o varnosti hrane.

en	In general, industry stakeholders state that the timing of publication could have a negative or very negative impact on competitiveness, in particular if publication happens early in the assessment process.
sl	Na splošno so zainteresirane strani iz industrije navedle, da bi imel časovni okvir objavljanja lahko negativen ali zelo negativen učinek na konkurenčnost, zlasti v primeru objave zgodaj v postopku ocenjevanja.

en	There is an exception to this in the stakeholder group of respondents: some NGOs (23.5 % of replies from stakeholders) do not consider that including general principles of risk communication in legislation would be very effective.
sl	Vendar v skupini zainteresiranih strani obstaja izjema: nekatere nevladne organizacije (23,5 % odgovorov) menijo, da vključitev splošnih načel obveščanja o tveganju v zakonodajo ne bi bila zelo učinkovita.

en	For respondents from the stakeholder group, these percentages were 47.7 %, 21.6 % and 9.2 %, respectively.
sl	V primeru sodelujočih zainteresiranih strani so ti deleži znašali 47,7 %, 21,6 % oziroma 9,2 %.

en	The stakeholders that took part represented a variety of sectors: trade and business associations (39.22 %), companies and groups (14.38 %), NGOs (13.07 %), professional associations (8.5 %), national/regional authorities (8.5 %), governmental agencies (5.23 %), research institutes (3.92 %), public bodies (1.96 %), professional consultancies (1.96 %), think-tanks (1.31 %), law firms (0.65 %), EU Institutions (0.65 %), and other (0.65 %).
sl	Zainteresirane strani, ki so sodelovale v posvetovanju, zastopajo različne sektorje: trgovinska in poslovna združenja (39,22 %), družbe in skupine (14,38 %), nevladne organizacije (13,07 %), poklicna združenja (8,5 %), nacionalne/regionalne organe (8,5 %), vladne agencije (5,23 %), raziskovalne inštitute (3,92 %), javne organe (1,96 %), poklicne svetovalne službe (1,96 %), možganske truste (1,31 %), odvetniške pisarne (0,65 %), institucije EU (0,65 %) in druge (0,65 %).

en	As consumers may in general lack the scientific knowledge to use these studies, consumer organisations suggested that trust would depend on other factors, e.g. third-party scrutiny of the studies.
sl	Ker potrošniki na splošno morda nimajo dovolj strokovnega znanja, da bi uporabili te študije, bi po mnenju združenj potrošnikov zaupanje temeljilo na drugih dejavnikih, npr. na pregledu študij s strani tretjih oseb.

en	Some citizens and stakeholders (including MS authorities) highlighted the need to clearly separate risk assessment and risk management and suggested having representation from other stakeholder groups as well.
sl	Nekateri državljani in zainteresirane strani (vključno z organi držav članic) so poudarili potrebo po jasnem ločevanju med ocenjevanjem in obvladovanjem tveganja ter predlagali, da bi bile zastopane tudi druge skupine zainteresiranih strani.

en	Furthermore, about 35 % of replies from stakeholders, in this case mainly industry organisations, state that publishing industry studies will be negative or very negative for both competitiveness and promoting innovation.
sl	Približno 35 % sodelujočih zainteresiranih strani, v tem primeru zlasti industrijske organizacije, pa je odgovorilo, da bo objavljanje študij industrije negativno ali zelo negativno tako za konkurenčnost kot za spodbujanje inovacij.

en	Adequate incentives are needed in order to ensure that EFSA obtains the expertise it needs from MS.
sl	Potrebne so ustrezne spodbude, da agencija EFSA iz držav članic lahko dobi strokovno znanje, ki ga potrebuje.

en	Need to tackle potential negative impacts of consultations on studies submitted on the length of the assessment processes.
sl	Potreba po obravnavanju morebitnih negativnih učinkov posvetovanj o predloženih študijah na trajanje postopka ocenjevanja.

en	Overall, in their replies citizens and stakeholders expressed the importance of the elements addressed by the Commission initiative to improve the EU risk assessment in the food chain.
sl	Na splošno so državljani in zainteresirane strani v svojih odgovorih izrazili pomembnost elementov, ki jih obravnava pobuda Komisije, za izboljšanje ocenjevanja tveganja v prehranski verigi v EU.

en	Overall, all consulted parties acknowledged the value of the actions aiming to improve risk communication.
sl	Na splošno so vse strani, ki so sodelovale v posvetovanju, potrdile vrednost ukrepov za izboljšanje obveščanja o tveganju.

en	There were different views on the timing of publishing non-confidential parts of industry studies throughout the risk assessment process and the impact on transparency.
sl	Obstajajo različna mnenja glede časovnega okvira za objavo nezaupnih delov študij industrije v celotnem postopku ocenjevanja tveganja in glede učinka na preglednost.

en	Although this was in general welcomed, some MS authorities and industry stakeholders mentioned the potential negative impact on the length of EFSA's risk assessment processes.
sl	Čeprav je bilo to na splošno dobro sprejeto, so organi nekaterih držav članic in zainteresirane strani iz industrije omenile morebiten negativni učinek na trajanje postopkov ocenjevanja tveganja agencije EFSA.

en	Discussions with stakeholders highlighted the potential for establishing procedures for open consultations on data related to the studies submitted by industry as part of authorisation dossiers.
sl	V razpravah z zainteresiranimi stranmi je bila poudarjena možnost za uvedbo postopkov za odprta posvetovanja o podatkih v zvezi s študijami, ki jih predloži industrija kot del dokumentacije za pridobitev odobritve.

en	In the OPC, over a third of citizens consider that existing risk communication does not contribute very much or at all to building trust in the EU's decision-making process in the food chain.
sl	Več kot tretjina sodelujočih državljanov je menila, da obstoječe obveščanje o tveganju le malo ali pa sploh ne prispeva h krepitvi zaupanja v postopek odločanja EU v prehranski verigi.

en	In addition, both citizens (75.2 %) and stakeholders (79.7 %) agree or strongly agree that the costs of national bodies' scientific contribution to EFSA's tasks should be adequately compensated.
sl	Poleg tega so se sodelujoči državljani (75,2 %) in zainteresirane strani (79,7 %) strinjali ali zelo strinjali, da bi morali biti stroški znanstvenega prispevka nacionalnih organov k nalogam agencije EFSA ustrezno povrnjeni.

en	The OPC received replies from 471 participants: 318 citizens and 153 stakeholders.
sl	V navedenem posvetovanju je svoje odgovore podalo 471 sodelujočih: 318 državljanov in 153 zainteresiranih strani.

en	The other financing options proposed, i.e. the EU budget, common funding provided by all industry applicants or a combination of public and industry funding, were considered relevant by 32.1 %, 27 % and 25.2 % of citizens, respectively.
sl	Druge predlagane možnosti financiranja, tj. financiranje iz proračuna EU, skupno financiranje s strani vseh vlagateljev iz industrije ali kombinacija financiranja s strani javnega sektorja in industrije, so pomembne po mnenju 32,1 %, 27 % oziroma 25,2 % sodelujočih državljanov.

en	Citizens and stakeholders acknowledged the importance of public access to the industry studies used by EFSA in its risk assessments, with the exception of the business secrets and other confidential information, as a significant element of ensuring trust in the EU's food safety risk assessment.
sl	Državljani in zainteresirane strani so potrdili pomembnost javnega dostopa do študij industrije, ki jih EFSA uporabi v svojih ocenah tveganja, z izjemo poslovnih skrivnosti in drugih zaupnih informacij, kot pomemben del zagotavljanja zaupanja v ocenjevanje tveganja v zvezi z varnostjo hrane v EU.

en	Further involvement of MS authorities in EFSA's activities must continue to ensure the separation between risk assessment and risk management.
sl	Potrebno je nadaljnje vključevanje organov držav članic v dejavnosti agencije EFSA, da se zagotovi ločevanje med ocenjevanjem in upravljanjem tveganja.

en	Some MS authorities highlighted the need to ensure a proper balance between EFSA's independence policies and its links with scientific excellence, and the need to consider incentives to stimulate the contribution of MS experts to EFSA's work, including financial and non-financial elements.
sl	Organi nekaterih držav članic so poudarili potrebo po zagotovitvi ustreznega ravnotežja med politikami neodvisnosti agencije EFSA in njeno povezavo z znanstveno odličnostjo ter potrebo po obravnavanju spodbud za večje prispevanje strokovnjakov držav članic k delu agencije EFSA, vključno s finančnimi in nefinančnimi elementi.

en	Some comments from MS authorities reflect on the need to specify what should be considered confidential in legislation.
sl	Nekatere pripombe organov držav članic se nanašajo na potrebo, da se določi, katere elemente bi bilo treba obravnavati kot zaupne v zakonodaji.

en	Details on what information from industry studies can be claimed as confidential need to be clear, and the related claims must be thoroughly assessed.
sl	Podrobnosti o informacijah iz študij industrije, za katere se lahko zahteva zaupnost, morajo biti jasne, s tem povezane zahteve pa temeljito ocenjene.

en	Some MS authorities and industry stakeholders considered that it may have a detrimental impact on EU innovation.
sl	Organi nekaterih držav članic in zainteresirane strani iz industrije so menili, da lahko škodljivo vplivajo na inovacije v EU.

en	Consumer organisations commented on the need to clearly explain the political choices made and improve the MS involvement in risk communication.
sl	Združenja potrošnikov so izrazila pripombe glede potrebe po jasnih obrazložitvah sprejetih političnih odločitev in izboljšanju sodelovanja držav članic pri obveščanju o tveganju.

en	Need for proportionate verification processes on the quality of industry studies as regards compliance with relevant standards.
sl	Potreba po sorazmernih postopkih za preverjanje kakovosti študij industrije v zvezi s skladnostjo z ustreznimi standardi.

en	Synopsis report
sl	Zbirno poročilo

en	Avoiding scientific divergences between the EU and national levels was considered to be useful or very useful by 72.3 % of respondents from the citizen group; this equals 79.1 % for the stakeholder group.
sl	Izogibanje znanstvenim razhajanjem med ravnjo EU in nacionalnimi ravnmi se zdi koristno ali zelo koristno 72,3 % sodelujočim iz skupine državljanov; za skupino zainteresiranih strani pa ta delež znaša 79,1 %.

en	As regards MS being represented in EFSA's Management Board, 57.5 % of citizens and 53.6 % of stakeholders agreed or strongly agreed.
sl	Kar zadeva države članice, zastopane v upravnem odboru agencije EFSA, se je 57,5 % sodelujočih državljanov in 53,6 % sodelujočih zainteresiranih strani strinjalo ali zelo strinjalo s tem.

en	Some MS, industry stakeholders, NGOs including consumer associations, and EFSA's Scientific Committee stressed that cooperation with MS needs to respect the independence of the experts in their contribution to EFSA and the separation between risk assessment and risk management.
sl	Nekatere države članice, zainteresirane strani iz industrije, nevladne organizacije, vključno z združenji potrošnikov, in znanstveni odbor agencije EFSA so poudarili, da je treba pri sodelovanju z državami članicami spoštovati neodvisnost strokovnjakov pri njihovem prispevanju k agenciji EFSA ter ločevanje med ocenjevanjem in obvladovanjem tveganja.

en	Most citizens and stakeholders found important or very important the elements currently in place to ensure that the studies provided by industry are sufficiently robust to serve EFSA's risk assessment needs.
sl	Za večino sodelujočih državljanov in zainteresiranih strani je pomembno ali zelo pomembno, da elementi, ki se trenutno uporabljajo, zagotavljajo, da so študije industrije dovolj zanesljive za potrebe ocenjevanja tveganja, ki ga opravlja agencija EFSA.

en	NGOs commented on the need to review the validity of the confidentiality claims made in relation to industry studies.
sl	Nevladne organizacije so izrazile pripombe glede potrebe po pregledu veljavnosti zahtev za zaupnost v zvezi s študijami industrije.

en	As regards the impact of publishing industry studies, 42.1 % of citizen replies and 21.6 % of stakeholder replies state that it is important or very important for competitiveness; 56.3 % of citizen replies and 31.4 % of stakeholder replies state that it is positive or very positive for innovation.
sl	Kar zadeva učinek objavljanja študij industrije, je 42,1 % sodelujočih državljanov in 21,6 % sodelujočih zainteresiranih strani odgovorilo, da je pomembno ali zelo pomembno za konkurenčnost; 56,3 % sodelujočih državljanov in 31,4 % sodelujočih zainteresiranih je navedlo, da je pozitivno ali zelo pozitivno za inovacije.

en	Potential value of EFSA's pre-submission advice to industry applicants while fully respecting the independence of scientific processes.
sl	Možna vrednost svetovanja, ki bi ga agencija EFSA zagotavljala vlagateljem iz industrije pred vložitvijo vloge, ob hkratnem spoštovanju neodvisnosti znanstvenih postopkov.

en	All the new measures proposed as potentially strengthening the consistency of risk communication were considered by most respondents from both groups to be effective or very effective (between 61.4 % and 92.2 % of replies).
sl	Vsi predlagani novi ukrepi, ki bi lahko okrepili doslednost obveščanja o tveganju, bi bili po mnenju večine sodelujočih državljanov in zainteresiranih strani učinkoviti ali zelo učinkoviti (61,4 % oz. 92,2 % odgovorov).

en	As regards the potential to re-enforce the audit system used for laboratories carrying out industry studies, the majority of both citizens (78.3 % of respondents) and stakeholders (72.6 % of respondents) considered that this would contribute to some or to a large extent to strengthening EFSA's risk assessments.
sl	Kar zadeva možnost okrepitve sistema presoj, ki se uporablja za laboratorije, ki izvajajo študije industrije, je večina državljanov (78,3 % vprašanih) in zainteresiranih strani (72,6 % vprašanih) menila, da bi to do neke mere ali v veliki meri prispevalo k okrepitvi ocenjevanja tveganja agencije EFSA.

en	Citizens evaluated their level of knowledge of the EU assessment system for food safety and its regulatory framework as very good (22.64 %), good (33.65 %), sufficient (26.42 %), little (14.78 %) or none (2.52 %).
sl	Državljani so ocenili svoje poznavanje sistema EU za ocenjevanje varnosti hrane in njegovega regulativnega okvira kot zelo dobro (22,64 %), dobro (33,65 %), zadovoljivo (26,42 %), slabo (14,78 %) ali neobstoječe (2,52 %).

en	83.7 % of replies from citizens and by 63.4 % from stakeholders stated that complementing industry studies with verification studies would strengthen EFSA's risk assessment to some or to a large extent.
sl	83,7 % državljanov in 63,4 % zainteresiranih strani, ki so sodelovali v posvetovanju, je navedlo, da bi dopolnitev študij industrije s preveritvenimi študijami do neke mere ali v veliki meri okrepila oceno tveganja agencije EFSA.

en	Over 40 % of citizen replies disagreed or strongly disagreed with the statement suggesting that MS are sufficiently involved in EFSA's work.
sl	Več kot 40 % sodelujočih državljanov je odgovorilo, da se ne strinja ali nikakor ne strinja z izjavo, da so države članice dovolj vključene v delo agencije EFSA.

en	Organisations evaluated their level of knowledge as very good (37.25 %), good (47.06 %), sufficient (14.38 %), little (0.65 %) or none (0.65 %).
sl	Organizacije so ocenile svoje poznavanje kot zelo dobro (37,25 %), dobro (47,06 %), zadovoljivo (14,38 %), slabo (0,65 %) ali neobstoječe (0,65 %).

en	Elements including EFSA being able to choose excellent and independent experts from a large pool of candidates, as well as its independence from risk managers (Commission and MS) and from industry, were found by over 80 % of respondents in both the citizen and stakeholder groups to be useful or very useful.
sl	Elementi, ki vključujejo možnost, da agencija EFSA lahko izbere odlične in neodvisne strokovnjake iz širokega nabora kandidatov, ter njeno neodvisnost od odgovornih za upravljanje tveganja (Komisije in držav članic) in od industrije, so po mnenju več kot 80 % sodelujočih državljanov in zainteresiranih strani koristni ali zelo koristni.

en	Citizens and stakeholders found that publishing industry studies, including raw/aggregated data but excluding business secrets or other confidential information, has a positive or very positive impact on:
sl	Državljani in zainteresirane strani menijo, da ima objavljanje študij industrije, vključno z neobdelanimi/zbirnimi podatki, razen poslovnih skrivnosti ali drugih zaupnih informacij, pozitiven ali zelo pozitiven učinek na:

en	Over 75 % of respondents from both groups considered it useful or very useful to avoid duplication of risk assessments between EU and national levels, and to ensure an appropriate level of resources for EFSA.
sl	Po mnenju več kot 75 % vprašanih iz obeh skupin sta izogibanje podvajanju ocenjevanja tveganja na ravni EU in nacionalnih ravneh ter zagotavljanje ustrezne ravni sredstev za agencijo EFSA koristni ali zelo koristni.

en	In particular, industry stakeholders considered valuable to some or to a large extent the possibility for providing pre-submission advice to individual applicants, while consumer organisations and some other NGOs considered that it would not contribute very much.
sl	Zlasti zainteresirane strani iz industrije so menile, da je možnost svetovanja posameznim vlagateljem pred vložitvijo vloge do neke mere ali v veliki meri pomembna, po mnenju združenj potrošnikov in nekaterih drugih nevladnih organizacij pa prispevek svetovanja ne bi bil zelo pomemben.

en	Both citizen and stakeholder replies to the OPC showed that an open registry of studies, the use of machine readable formats and having different levels of access to studies would be useful or very useful tools.
sl	Po mnenju državljanov in zainteresiranih strani, ki so sodelovali v odprtem javnem posvetovanju, bi bili odprt register študij, uporaba strojno berljivih formatov in uporaba različnih ravni dostopa do študij koristna ali zelo koristna orodja.

en	Among citizens, 58.8 % considered that immediate publication without confidentiality checks would have a positive or very positive impact, 6.9 % consider it would have no impact and 28.9 % considered that the impact would be negative or very negative.
sl	58,8 % sodelujočih državljanov je menilo, da bi imela takojšnja objava brez preverjanja zaupnosti pozitiven ali zelo pozitiven učinek, 6,9 % jih je menilo, da to ne bi imelo nikakršnega učinka, po mnenju 28,9 % sodelujočih državljanov pa bi bil učinek negativen ali zelo negativen.

en	In general, citizens found that all the additional measures regarding industry studies proposed in the OPC contribute to some or a large extent to strengthening EFSA's risk assessments; over 75 % of replies regarding the single measures acknowledged this.
sl	Na splošno so državljani menili, da vsi dodatni ukrepi glede študij industrije, predlagani v odprtem javnem posvetovanju, do neke mere ali v veliki meri prispevajo k okrepitvi ocenjevanja tveganja agencije EFSA; to potrjuje več kot 75 % odgovorov glede posameznih ukrepov.

en	It was found that the tools currently available to support scientific cooperation between EFSA and MS to a significant extent already engage MS in the EU risk assessment system: over 70 % of respondents (both citizen and stakeholder groups) found that all the tools described contribute to some or a large extent.
sl	Ugotovljeno je bilo, da orodja, ki so trenutno na voljo za podporo znanstvenega sodelovanja med agencijo EFSA in državami članicami, v veliki meri že vključujejo države članice v sistem EU za ocenjevanje tveganja: več kot 70 % vprašanih (tako iz skupine državljanov kot iz skupine zainteresiranih strani) je menilo, da vsa opisana orodja do neke mere ali v veliki meri prispevajo k temu.

en	Replies on the other scenarios related to the timing of publication do not showed strong polarisation of opinions, with the exception of the option to not publish industry studies at all: 77.1 % of citizens state that this would have a negative or very negative impact, with only 4.1 % considering that it would have a positive or very positive impact.
sl	Odgovori glede ostalih scenarijev v zvezi s časovnim okvirom objavljanja niso pokazali velikih razlik v mnenju, z izjemo možnosti, da se študije industrije sploh ne bi objavljale: 77,1 % sodelujočih državljanov je navedlo, da bi to imelo negativen ali zelo negativen učinek, samo 4,1 % pa jih je menilo, da bi to imelo pozitiven ali zelo pozitiven učinek.

en	Both citizens and stakeholders considered that allocating more public resources to financing food safety studies is important for strengthening EFSA's risk assessment: around 80 % of citizen replies state that EU or national funding could contribute to some or to a large extent; the figure for stakeholders is slightly lower.
sl	Državljani in zainteresirane strani so menili, da je dodelitev več javnih sredstev za financiranje študij o varnosti hrane pomembna za okrepitev ocenjevanja tveganja agencije EFSA: približno 80 % sodelujočih državljanov je odgovorilo, da bi lahko financiranje EU ali nacionalno financiranje do neke mere ali v veliki meri prispevalo k temu; v primeru zainteresiranih strani pa je ta delež nekoliko nižji.

en	allowing scrutiny by other scientific and third parties: 81.8 % of replies from citizens, 80.4 % from stakeholders,
sl	omogočanje pregleda drugim znanstvenim in tretjim osebam: 81,8 % odgovorov državljanov, 80,4 % odgovorov zainteresiranih strani,

en	[1: https://ec.europa.eu/food/safety/general_food_law/fitness_check_en ][2: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_glyphosate_eci_final.pdf ]
sl	][2: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_glyphosate_eci_final.pdf. ]

en	For stakeholders, 71.9 % believe that the non-publication of industry studies would have a negative or very negative impact and only 1.3 % considered that it would have a positive impact.
sl	Po mnenju 71,9 % sodelujočih zainteresiranih strani bi imelo neobjavljanje študij industrije negativen ali zelo negativen učinek, le 1,3 % pa jih je menilo, da bi imelo pozitiven učinek.

en	enhancing the exchange of information on risk among interested parties: 81.5 % of replies from citizens, 76.5 % from stakeholders.
sl	izboljšanje izmenjave informacij o tveganju med zainteresiranimi stranmi: 81,5 % odgovorov državljanov, 76,5 % odgovorov zainteresiranih strani.

en	strengthening consumer trust in the EU risk assessment system: 84.9 % of replies from citizens, 73.9 % from stakeholders,
sl	okrepitev zaupanja potrošnikov v sistem EU za ocenjevanje tveganja: 84,9 % odgovorov državljanov, 73,9 % odgovorov zainteresiranih strani,

en	Some MS saw the potentially for a small value of pre-submission advice in relation to its cost vs benefit analysis.
sl	Po mnenju nekaterih držav članic bi lahko imelo svetovanje pred vložitvijo vloge glede na analizo stroškov in koristi le majhno vrednost.

en	Most respondents (over 75 % in both the citizen and stakeholder groups) agreed or strongly agreed that an increased involvement of MS is important to ensure that EFSA has a large pool of experts from MS. MS authorities highlighted the importance of incentives when promoting cooperation.
sl	Večina vprašanih (več kot 75 % sodelujočih državljanov in zainteresiranih strani) se je strinjala ali zelo strinjala, da je večja vključenost držav članic pomembna, da se zagotovi, da ima EFSA na voljo širok nabor strokovnjakov iz držav članic.

en	However, 27.7 % of citizen replies and 26.1 % of stakeholder replies disagree or strongly disagree with this statement.
sl	Vendar se s to izjavo ni strinjalo ali nikakor ni strinjalo 27,7 % sodelujočih državljanov in 26,1 % sodelujočih zainteresiranih strani.

en	The possibility of choosing excellent and independent experts from a large pool of candidates scored higher, with 96.2 % of citizen replies and 98.7 % of stakeholder replies considering it useful or very useful.
sl	Možnost izbire odličnih in neodvisnih strokovnjakov iz širokega nabora kandidatov pa se zdi koristna ali zelo koristna večjemu številu vprašanih, in sicer 96,2 % državljanom in 98,7 % zainteresiranim stranem.

en	enhancing the transparency of the EU risk assessment system: 87.4 % of replies from citizens, 91.5 % from stakeholders,
sl	izboljšanje preglednosti sistema EU za ocenjevanje tveganja: 87,4 % odgovorov državljanov, 91,5 % odgovorov zainteresiranih strani,

en	[5: https://ec.europa.eu/food/expert-groups/ag-ap/adv-grp_fchaph/wg_2018_en ][6: https://www.efsa.europa.eu/en/events/event/180206 ][7: https://ec.europa.eu/food/safety/general_food_law/expert_group_en ][8: https://www.efsa.europa.eu/sites/default/files/event/180214-m.pdf ]
sl	][8: https://www.efsa.europa.eu/sites/default/files/event/180214-m.pdf. ]

en	Citizens and stakeholders had the opportunity to provide feedback on a Commission roadmap from 20 December 2017 to 17 January 2018.
sl	Državljani in zainteresirane strani so imeli priložnost predložiti povratne informacije glede časovnega načrta Komisije od 20. decembra 2017 do 17. januarja 2018. 20 zainteresiranih strani (15 trgovinskih in poslovnih združenj, štiri nevladne organizacije, en nacionalni organ) in en državljan so predložili povratne informacije.

en	The OPC showed such access as important or very important in 86.8 % of citizen replies and 88.2 % of stakeholder replies.
sl	V odprtem javnem posvetovanju je 86,8 % sodelujočih državljanov in 88,2 % sodelujočih zainteresiranih strani odgovorilo, da je tak dostop pomemben ali zelo pomemben.

en	This proposal was meanwhile adopted and entered into force on 30 March.
sl	Ta predlog je bil medtem sprejet in je začel veljati 30. marca.

en	Hence, it can only be of a temporary nature.
sl	Zato je lahko le začasne narave.

en	A rigorous and conservative approach to financial management;
sl	strog in konservativen pristop k finančnemu upravljanju;

en	It does not go beyond what is necessary to achieve the objectives sought by the instrument.
sl	Ne presega tistega, kar je potrebno za doseganje ciljev instrumenta.

en	The Member State concerned should request support.
sl	Zadevna država članica bi morala zaprositi za podporo.

en	This system will allow the Union to:
sl	Ta sistem bo Uniji omogočil, da:

en	from candidate countries[11: Candidate countries and, where applicable, potential candidate countries from the Western Balkans.]
sl	držav kandidatk[11: Države kandidatke in po potrebi potencialne države kandidatke z Zahodnega Balkana.]

en	From the beginning of the outbreak in the Union up until 30 March 2020, 334 396 cases and 22 209 deaths have been reported in the Member States.
sl	Od začetka izbruha v Uniji do 30. marca 2020 je bilo v državah članicah sporočenih 334 396 primerov okužbe in 22 209 smrti.

en	It concerns an amount of up to EUR 100 billion.
sl	Ta znaša največ 100 milijard EUR.

en	The Council has a broad margin of discretion for assessing whether the conditions of this legal basis are fulfilled.
sl	Svet ima široko diskrecijsko pravico pri oceni, ali so pogoji te pravne podlage izpolnjeni.

en	Therefore, the United Kingdom should not participate in the financial assistance under this Regulation.
sl	Zato Združeno kraljestvo ne bi smelo sodelovati pri finančni pomoči v skladu s to uredbo.

en	The probability of further transmission of COVID-19 in the Union is considered high.
sl	Verjetnost nadaljnjega prenosa COVID-19 v Uniji se šteje za visoko.

en	Such a consultation also helps the Commission to properly evaluate the terms of the loan.
sl	Tako posvetovanje bi Komisiji tudi pomagalo ustrezno oceniti pogoje posojila.

en	To that end, the Member State concerned shall provide the Commission with appropriate evidence.
sl	V ta namen zadevna država članica Komisiji predloži ustrezne dokaze.

en	The Commission shall inform the Council when the Instrument becomes available.
sl	Komisija obvesti Svet, ko je instrument na voljo.

en	DG BUDG is the policy area or budget title concerned.
sl	GD BUDG je zadevno področje ali naslov v proračunu.

en	The Commission and the beneficiary Member State will conclude an implementation agreement.
sl	Komisija in država članica upravičenka skleneta sporazum o izvajanju.

en	The global outbreak of that disease is evolving rapidly and it has been declared a pandemic by the WHO.
sl	Svetovni izbruh te bolezni se hitro razvija, SZO pa ga je razglasila za pandemijo.

en	References to Member States in this Regulation shall not be understood as including the United Kingdom.
sl	Sklicevanja na države članice v tej uredbi se ne razumejo, kot da vključujejo Združeno kraljestvo.

en	Possibilities to roll over debt.
sl	možnosti obnovitve dolga.

en	The Economic and Financial Committee shall be kept informed of a refinancing or restructuring as referred to in paragraph 3.
sl	Ekonomsko-finančni odbor je redno obveščen o refinanciranju ali prestrukturiranju iz odstavka 3.

en	Officials and temporary staff Issuance of securities in the capital markets (market analysis, prospectus, registration, investors relationship), management of proceeds, disbursements and reimbursements
sl	Uradniki in začasni uslužbenci Izdaja vrednostnih papirjev na kapitalskih trgih (tržna analiza, prospekt, registracija, odnosi z vlagatelji), upravljanje prihodkov, izplačil in povračil

en	The Commission has also established a coordinating response team at political level, composed of the five Commissioners responsible for the most affected policies.
sl	Komisija je ustanovila tudi skupino za usklajevanje odzivanja na politični ravni, ki jo sestavlja pet komisark in komisarjev, pristojnih za področja politike, ki jih ta kriza najbolj zadeva.

en	The maximum amount of financial assistance referred to in Article 3 shall not exceed EUR 100 000 000 000 for all Member States.
sl	Najvišji znesek finančne pomoči iz člena 3 ne presega 100 000 000 000 EUR za vse države članice.

en	The rules of Article 220 of the Financial Regulation apply.
sl	Uporabljajo se pravila iz člena 220 finančne uredbe.

en	Due to the urgency to prepare the proposal so that it can be adopted in a timely manner by the Council, a stakeholder consultation could not be carried out.
sl	Zaradi nujne čimprejšnje priprave predloga, da bi ga Svet lahko pravočasno sprejel, posvetovanja z zainteresiranimi stranmi ni bilo mogoče izvesti.

en	from EFTA countries[10: EFTA: European Free Trade Association. ]
sl	držav Efte[10: EFTA: Evropsko združenje za prosto trgovino. ]

en	Having regard to the Treaty on the Functioning of the European Union, and in particular Article 122 thereof,
sl	ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 122 Pogodbe,

en	As announced in the Communication of 13 March 2020, the Union also stands ready to support Member States where possible in alleviating the employment impact for individuals and the hardest hit sectors.
sl	Kot je bilo napovedano v sporočilu z dne 13. marca 2020, je Unija, kjer je to mogoče, pripravljena podpreti države članice tudi pri ublažitvi učinka na zaposlenost za posameznike ter za najbolj prizadete sektorje.

en	[6: ABM: activity-based management; ABB: activity-based budgeting.]
sl	[6: ABM: upravljanje po dejavnostih, ABB: oblikovanje proračuna po dejavnostih.]

en	The loans issued by the Union should therefore be financed by recourse to international capital markets.
sl	Posojila, ki jih izda Unija, bi bilo zato treba financirati z uporabo mednarodnih kapitalskih trgov.

en	Contributions in the form of guarantees from Member States
sl	Prispevki držav članic v obliki jamstev

en	[7: As referred to in Article 54(2)(a) or (b) of the Financial Regulation.]
sl	[7: Po členu 54(2)(a) oz. (b) finančne uredbe.]

en	The Commission has activated its general rapid alert system "ARGUS" for crisis coordination and the Crisis Coordination Committee meets regularly to coordinate the actions of all the relevant departments and services of the Commission and of the EU agencies.
sl	Komisija je aktivirala splošni sistem za hitro opozarjanje (ARGUS) za krizno usklajevanje in odbor za krizno usklajevanje se redno sestaja, da usklajuje ukrepe vseh ustreznih oddelkov in služb Komisije ter agencij EU.

en	Member States shall be reimbursed for such additional contributions from recovered amounts.
sl	Državam članicam se ti dodatni prispevki povrnejo iz izterjanih zneskov.

en	The Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2), causing the coronavirus disease, named COVID-19 by the World Health Organisation (WHO), is a new strain of coronavirus not previously identified in humans.
sl	(3) Koronavirus 2 hudega akutnega respiratornega sindroma (SARS-CoV-2), ki povzroča koronavirusno bolezen, ki jo je Svetovna zdravstvena organizacija (SZO) poimenovala COVID-19, je nov sev koronavirusa, ki prej pri ljudeh ni bil ugotovljen.

en	[This section should be filled in using the spreadsheet on budget data of an administrative nature (second document in annex to this financial statement) and uploaded to CISNET for interservice consultation purposes.]
sl	[Ta oddelek se izpolni s preglednico o proračunskih podatkih upravne narave (drugi dokument v prilogi k tej oceni finančnih posledic) in prenesti na CISNET za namene posvetovanj med službami.]

en	The Union adopted on this legal basis Regulation (EU) No 407/2010 of the Council of 11 May 2010 establishing a European Financial Stabilisation Mechanism (EFSM).
sl	Unija je v skladu s to pravno podlago sprejela Uredbo Sveta (EU) št. 407/2010 z dne 11. maja 2010 o vzpostavitvi Evropskega mehanizma za finančno stabilizacijo.

en	- appropriate measures can be taken by the Union to respond in a spirit of solidarity between Member States to a specific economic situation.
sl	- Unija lahko sprejme ustrezne ukrepe, da se v duhu solidarnosti med državami članicami odzove na posebne gospodarske razmere,

en	The Commission shall establish the necessary arrangements for the administration of the loans with the ECB.
sl	Komisija določi potrebne ureditve za upravljanje posojil skupaj z ECB.

en	Given the impact of the COVID-19 outbreak and the need for an urgent response to the consequences of that outbreak, this Regulation should enter into force on the date of its publication in the Official Journal of the European Union,
sl	(16) Glede na vpliv izbruha COVID-19 in potrebo po nujnem odzivu na posledice tega izbruha bi morala ta uredba začeti veljati na dan objave v Uradnem listu Evropske unije -

en	Following the EU leaders' videoconferences on the response to the COVID-19 outbreak on 10, 17, and 26 March 2020, the Commission is further stepping up its response to the COVID-19 outbreak, on all fronts.
sl	Komisija je po videokonferencah voditeljev EU o odzivu na izbruh COVID-19, ki so potekale 10., 17., in 26. marca 2020, na vseh področjih še okrepila svoj odziv na izbruh COVID-19.

en	Article 122(2) TFEU has been used once before.
sl	Člen 122(2) PDEU je bil enkrat že uporabljen.

en	This Regulation shall not be applicable to and in the United Kingdom.
sl	Ta uredba se ne uporablja za Združeno kraljestvo in v njem.

en	This act takes the form of a Regulation because the act creates a new specific and temporary instrument that could be used by any Member State and has to be binding in its entirety and directly applicable in all Member States.
sl	Ta akt je v obliki uredbe, saj vzpostavlja nov poseben in začasen instrument, ki bi ga lahko uporabila katera koli država članica ter mora biti v celoti zavezujoč in se neposredno uporabljati v vseh državah članicah.

en	Due to the urgent nature of the proposal, no impact assessment was carried out.
sl	Zaradi nujne čimprejšnje priprave predloga ni bila opravljena nobena ocena učinka.

en	This legal basis prescribes that:
sl	Ta pravna podlaga določa naslednje:

en	Such contributions would constitute external assigned revenue.
sl	Taki prispevki bi pomenili zunanje namenske prejemke.

en	Article 122(2) TFEU can be used for any type of exceptional crisis event and is not confined to crises of a financial or financial stability nature only.
sl	Člen 122(2) PDEU se lahko uporabi za vse vrste izrednih kriznih dogodkov in ni omejen le na finančne krize ali krize finančne stabilnosti.

en	The agreement shall set out the payment conditions.
sl	V sporazumu so določeni pogoji glede plačila.

en	In this respect, the Commission has published a Communication to the European Parliament, the European Council, the Council, the European Central Bank, the European Investment Bank and the Eurogroup for a "coordinated economic response to the COVID-19 outbreak" on 13 March 2020.
sl	V zvezi s tem je 13. marca 2020 objavila sporočilo Evropskemu parlamentu, Evropskemu svetu, Svetu, Evropski centralni banki, Evropski investicijski banki in Euroskupini o usklajenem gospodarskem odzivu na izbruh COVID-19.

en	an assessment of the compliance by the Member State with the conditions referred to in Article 3;
sl	(b) oceno, ali država članica izpolnjuje pogoje iz člena 3;

en	The present proposal comes in addition to another Union law instrument to provide support to Member States in case of emergencies, namely Council Regulation (EC) No 2012/2002 of 11 November 2002 establishing the European Union Solidarity Fund (EUSF) ("Regulation (EC) No 2012/2002").
sl	Ta predlog dopolnjuje drug instrument prava Unije za zagotavljanje podpore državam članicam v izrednih razmerah, in sicer Uredbo Sveta (ES) št. 2012/2002 z dne 11. novembra 2002 o ustanovitvi Solidarnostnega sklada Evropske unije (v nadaljnjem besedilu: Uredba (ES) št. 2012/2002).

en	The geographical scope is also different because SURE is limited to Member States and does not extend to countries negotiating their accession to the Union.
sl	Geografsko področje uporabe je prav tako različno, saj je instrument SURE omejen na države članice in ne zajema držav, ki se pogajajo o pristopu k Uniji.

en	The share of loans granted to the three Member States representing the largest share of loans granted shall not exceed 60% of the amount referred to in Article 5.
sl	Delež posojil, odobrenih trem državam članicam, ki predstavljajo največji delež odobrenih posojil, ne presega 60 % zneska iz člena 5.

en	The Commission has also adopted a Temporary Framework for State aid to enable Member States to use the full flexibility foreseen under State aid rules to support their economies.
sl	Komisija je sprejela začasni okvir za državno pomoč, da bi lahko države članice v celoti izkoristile prilagodljivost, predvideno s pravili o državni pomoči, za podporo svojim gospodarstvom.

en	Regulation (EU) 2020/461 of the European Parliament and of the Council, which amends that instrument to extend its scope to cover major public health emergencies and to define specific operations eligible for financing, was adopted on 30 March.
sl	Uredba (EU) 2020/461 Evropskega parlamenta in Sveta, ki spreminja navedeni instrument, da bi se razširilo njegovo področje uporabe na izredne razmere večjih razsežnosti v javnem zdravju in opredelile posebne dejavnosti, upravičene do financiranja, je bila sprejeta 30. marca.

en	[5: Definitive adoption (EU, Euratom) 2020/227 of the European Union's general budget for the financial year 2020, (OJ L 57, 27.02.2020.
sl	[5: Dokončno sprejetje (EU, Euratom) 2020/227 splošnega proračuna Evropske unije za proračunsko leto 2020 (UL L 57, 27.2.2020, str.

en	The amounts due by the Union in a given year shall not exceed 10% of the amount referred to in Article 5.
sl	Zneski, ki jih dolguje Unija v danem letu, ne presegajo 10 % zneska iz člena 5.

en	The proposal aims to offer financial support in a spirit of European solidarity with those Member States that are heavily affected.
sl	Namen predloga je ponuditi finančno podporo v duhu evropske solidarnosti z močno prizadetimi državami članicami.

en	[3: Regulation (EU, Euratom) 1046/2018 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014 and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p.
sl	[3: Uredba (EU, Euratom) 2018/1046 Evropskega parlamenta in Sveta z dne 18. julija 2018 o finančnih pravilih, ki se uporabljajo za splošni proračun Unije, spremembi uredb (EU) št. 1296/2013, (EU) št. 1301/2013, (EU) št. 1303/2013, (EU) št. 1304/2013, (EU) št. 1309/2013, (EU) št. 1316/2013, (EU) št. 223/2014, (EU) št. 283/2014 in Sklepa št. 541/2014/EU ter razveljavitvi Uredbe (EU, Euratom) št. 966/2012 (UL L 193, 30.7.2018, str.

en	The proposed Regulation provides for a reporting clause (Article 14).
sl	Predlagana uredba vsebuje klavzulo o poročanju (člen 14).

en	The decision to make available the financial assistance referred to in Article 3 shall contain:
sl	Sklep o zagotovitvi finančne pomoči iz člena 3 vsebuje:

en	At the request of the beneficiary Member State and where circumstances permit an improvement in the interest rate on the loan, the Commission may refinance all or part of its initial borrowing or restructure the corresponding financial conditions.
sl	Na prošnjo države članice upravičenke in kadar okoliščine dovoljujejo ugodnejšo obrestno mero posojil, lahko Komisija refinancira vsa ali del svojih prvotnih posojil ali prestrukturira ustrezne finančne pogoje.

en	[2: OJ C 384 I, 12.11.2019, p.
sl	[2: UL C 384 I, 12.11.2019, str.

en	Articles 13 and 14 of the proposed Regulation lay down rules on controls and audits and reporting.
sl	Člena 13 in 14 predlagane uredbe določata pravila o kontroli, revizijah in poročanju.

en	Payments -
sl	plačila -

en	Since the first cases of COVID-19 contagion, the European Union has been working tirelessly to support Member States and their citizens in addressing the crisis.
sl	Evropska unija vse od prvih primerov okužbe s COVID-19 neumorno podpira države članice in njihove državljane pri reševanju nastale krize.

en	The guarantees committed to the Union should be irrevocable, unconditional and on demand and laid down in an agreement concluded between the Commission and the Member States.
sl	Zagotovljena jamstva za Unijo bi morala biti nepreklicna, brezpogojna in na zahtevo, določiti pa bi jih bilo treba v sporazumu med Komisijo in državami članicami.

en	To that end, and in accordance with a Council implementing decision adopted pursuant to Article 6(1), the Commission shall be empowered to borrow on the capital markets or with financial institutions on behalf of the Union at the most appropriate time so as to optimise the cost of funding and preserve its reputation as the Union's issuer in the markets.
sl	V ta namen in v skladu z izvedbenim sklepom Sveta, sprejetim v skladu s členom 6(1), je Komisija pooblaščena, da na kapitalskih trgih ali od finančnih institucij najame posojilo v imenu Unije v najugodnejšem času, da tako optimizira stroške financiranja in ohrani svoj ugled izdajatelja Unije na teh trgih.

en	The beneficiary Member State shall open a special account with its national central bank for the management of the financial assistance received.
sl	Država članica upravičenka pri svoji nacionalni centralni banki odpre poseben račun za upravljanje prejete finančne pomoči.

en	However, it is in current exceptional circumstances of the COVID-19 outbreak impossible to tell how long this situation lasts and for how long it will generate economic impact on working people in Member States.
sl	Vendar pa je v trenutnih izjemnih okoliščinah izbruha COVID-19 nemogoče napovedati, kako dolgo bodo trajale sedanje razmere in kako dolgo bodo povzročale gospodarske posledice za delovno aktivno prebivalstvo v državah članicah.

en	Moreover, the Commission has also called on the Council to ensure that the Union institutions activate the general escape clause under the Stability and Growth Pact, and the Union institutions will apply that clause as part of the strategy of the Union to respond quickly, forcefully and in a coordinated fiscal manner to the COVID-19 pandemic.
sl	Poleg tega je pozvala Svet, naj zagotovi, da bodo institucije Unije aktivirale splošno odstopno klavzulo Pakta za stabilnost in rast ter jo uporabile kot del strategije Unije za hiter, odločen in usklajen fiskalni odziv na pandemijo COVID-19.

en	[8: Details of management modes and references to Regulation (EU, Euratom) 1046/2018 may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html]
sl	[8: Pojasnila o načinih upravljanja in sklici na Uredbo (EU, Euratom) 2018/1046 so na voljo na spletišču BudgWeb: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html]