FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: 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").
Slovenian: 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").
English: 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:
Slovenian: Člane znanstvenih svetov imenuje upravni odbor za petletni mandat z možnostjo podaljšanja v skladu z naslednjim postopkom:
English: Impact assessment
Slovenian: Ocena učinka
English: 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.
Slovenian: Države članice zagotovijo, da lahko člani znanstvenih svetov posvetijo dovolj časa in truda delu agencije.
English: Further measures should also be put in place to ensure that scientific experts have the means to act independently.
Slovenian: Vzpostaviti bi bilo treba tudi dodatne ukrepe, ki bodo omogočili neodvisno delovanje znanstvenih strokovnjakov.
English: 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.
Slovenian: 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.
English: (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 […],
Slovenian: (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 […] -
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The process to be followed for the processing of confidentiality claims is also set up.
Slovenian: Prav tako je določen postopek za obravnavo zahtev za zaupnost.
English: EFSA Single Programming Document (SPD), EFSA Management Board meeting (responsible for Authority's governance), EFSA Annual report activities.
Slovenian: Enotni programski dokument agencije EFSA, seja upravnega odbora agencije EFSA (odgovornega za upravljanje agencije EFSA), dejavnosti, povezane z letnim poročilom agencije EFSA.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: V ta namen predlog določa medsektorski seznam informacij, katerih razkritje bi lahko znatno škodovalo zadevnim poslovnim interesom, zato se ne bi smele razkriti javnosti.
English: Consistency with existing policy provisions in the policy area
Slovenian: Skladnost z veljavnimi predpisi s področja zadevne politike
English: 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).
Slovenian: Komisija takoj obvesti države članice in posreduje zahtevek Evropski agenciji za varnost hrane (v nadaljnjem besedilu: urad).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The members and alternate members thus nominated shall be appointed by the Council and have voting rights.
Slovenian: Tako predlagane člane in nadomestne člane imenuje Svet in imajo glasovalno pravico.
English: (b) The following paragraphs 5a to 5g are inserted:
Slovenian: (b) vstavijo se naslednji odstavki 5a do 5g:
English: The relevant items shall be available to download, print and search through in an electronic format.
Slovenian: Zadevni dokumenti so v elektronski obliki na voljo za prenos, tisk in iskanje.
English: 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.
Slovenian: Na zahtevo morebitnega vlagatelja vloge za odobritev na podlagi živilske zakonodaje osebje agencije svetuje o zadevnih določbah in potrebni vsebini vloge za odobritev.
English: For the adoption of standard data formats and software packages the following procedure shall be followed:
Slovenian: Standardne oblike zapisa podatkov in paketi programske opreme se sprejmejo po naslednjem postopku:
English: It will help applicants in particular small and medium sized enterprises in understanding how to prepare authorisation applications.
Slovenian: Vložniki, zlasti mala in srednja podjetja, bodo lažje razumela, kako je treba pripraviti vloge za odobritev.
English: (2) Regulation (EC) No 178/2002 defines "risk analysis" as a process consisting of three interconnected components: risk assessment, risk management and risk communication.
Slovenian: (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.
English: 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.
Slovenian: 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.
English: (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;
Slovenian: (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;
English: The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The risk analysis principle consists of three separate but interconnected components: risk assessment, risk management and risk communication.
Slovenian: Načelo analize tveganja je sestavljeno iz treh ločenih, a medsebojno povezanih sestavnih delov: ocene tveganja, obvladovanja tveganja in obveščanja o tveganju.
English: 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."
Slovenian: 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.
English: Estimated impact on the staff (additional FTE) - establishment plan
Slovenian: Ocenjene posledice za osebje (dodatni EPDČ) - kadrovski načrt
English: 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.
Slovenian: 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.
English: The confidential version shall contain all information submitted, including information the applicant deems confidential.
Slovenian: Zaupna različica vsebuje vse predložene informacije, vključno z informacijami, ki jih vlagatelj šteje za zaupne.
English: [1) improve and clarify the rules on transparency, especially with regard to the scientific studies supporting the risk assessment;
Slovenian: [1) izboljšati in pojasniti pravila o preglednosti, zlasti glede znanstvenih študij v podporo oceni tveganja;
English: (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).
Slovenian: (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.
English: It ensures that action can be taken at Union level where there are exceptional circumstances of serious controversies or conflicting results.
Slovenian: Zagotavlja, da je mogoče ukrep v izrednih okoliščinah - če gre za sporna vprašanja ali nasprotujoče si rezultate - sprejeti na ravni Unije.
English: Regulatory fitness and simplification
Slovenian: Ustreznost in poenostavitev ureditve
English: The transparency provisions are without prejudice to any existing Intellectual Property Rights and data exclusivity provisions set out in Union sectoral food legislation.
Slovenian: Določbe o preglednosti ne posegajo v obstoječe pravice intelektualne lastnine in določbe o izključnosti podatkov iz sektorske živilske zakonodaje Unije.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Amendments to Regulation (EU) No 2015/2283 on novel foods
Slovenian: Spremembe Uredbe (EU) 2015/2283 o novih živilih
English: EFSA provides the advice in a transparent way since it makes it public.
Slovenian: Svetovanje agencije EFSA je pregledno, saj je na voljo javnosti.
English: (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,
Slovenian: (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
English: 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.
Slovenian: 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.
English: Officials (AST grades)
Slovenian: Uradniki (razredi AST)
English: 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.
Slovenian: 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.
English: Seconded National Experts
Slovenian: Napoteni nacionalni strokovnjaki
English: (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.
Slovenian: (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.
English: 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.
Slovenian: 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.
English: (i) advice provided by the Authority to potential applicants at pre-submission phase pursuant to Article 32a and 32c.
Slovenian: (i) mnenje, ki ga agencija predloži morebitnim vlagateljem pred vložitvijo vloge v skladu s členoma 32a in 32c.
English: 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.
Slovenian: 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.
English: (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,
Slovenian: (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
English: 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.
Slovenian: 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.
English: YES NO NO NO
Slovenian: NE DA/NE
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Amendments to Regulation (EC) No 1107/2009 on plant protection products
Slovenian: Spremembe Uredbe (ES) št. 1107/2009 o fitofarmacevtskih sredstvih
English: (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.
Slovenian: (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.
English: (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;
Slovenian: (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;
English: 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.
Slovenian: 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.
English: This should give EFSA greater legitimacy in the eyes of consumers and the general public, increasing their confidence in its work.
Slovenian: Tako naj bi se povečala legitimnost agencije EFSA v očeh potrošnikov in splošne javnosti ter s tem tudi njihovo zaupanje v njeno delo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: (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.
Slovenian: (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.
English: (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.
Slovenian: (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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: (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.
Slovenian: (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.
English: (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.
Slovenian: (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.
English: 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.
Slovenian: 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.
English: Member States shall launch a call for interest as a basis for their nominations.
Slovenian: Države članice objavijo razpis za prijavo interesa, na podlagi katerega predlagajo svoje kandidate.
English: 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.
Slovenian: 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.
English: (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;
Slovenian: (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;
English: (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.
Slovenian: (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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: [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.]
Slovenian: [52: Glej člena 11 in 17 Uredbe Sveta (EU, Euratom) št. 1311/2013 o večletnem finančnem okviru za obdobje 2014-2020.]
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Duration and financial impact
Slovenian: Trajanje ukrepa in finančnih posledic
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Ta predlog določa eno pooblastilo za delegirani akt v okviru Uredbe (ES) št. 178/2002, ki je v postopku usklajevanja.
English: The Authority shall lay down in its internal rules the practical arrangement for implementing the procedures referred to in Articles 32a and this Article.
Slovenian: Agencija v svojem poslovniku določi praktično ureditev za izvajanje postopkov iz člena 32a in tega člena.
English: Confidentiality
Slovenian: Zaupnost
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: under HEADING 5
Slovenian: RAZDELKA 5
English: (a) promote awareness and understanding of the specific issues under consideration during the entire risk analysis process;
Slovenian: (a) spodbujanje ozaveščenosti o posebnih vprašanjih, obravnavanih v celotnem postopku analize tveganja, in njihovega razumevanja;
English: 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.
Slovenian: 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.
English: (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.
Slovenian: (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.
English: (b) one member appointed by the European Parliament, with the right to vote.
Slovenian: (b) en član z glasovalno pravico, ki ga imenuje Evropski parlament;
English: under HEADINGS 1 to 5
Slovenian: RAZDELKOV od 1 do 5
English: 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.
Slovenian: 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.
English: In order of multiannual financial framework headings and budget lines.
Slovenian: Po vrstnem redu razdelkov večletnega finančnega okvira in proračunskih vrstic.
English: (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.
Slovenian: (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.
English: (a) make public, without delay, the non-confidential version, as submitted by the applicant;
Slovenian: (a) nemudoma objavi nezaupno različico, kot jo je predložil vlagatelj;
English: (a) two members and the alternate members appointed by the Commission and representing the Commission, with the right to vote.
Slovenian: (a) dva člana in nadomestna člana z glasovalno pravico, ki jih imenuje Komisija in predstavljajo Komisijo;
English: Total 8.5 14.9 21.2 21.2 21.2
Slovenian: Skupaj 8,5 14,9 21,2 21,2 21,2
English: Insourcing routine work 15 FTEs 0.775 1.357 1.938
Slovenian: Notranje izvajanje rutinskega dela 15 EPDČ 0,775 1,357 1,938