FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: "(c) the Authority shall without delay:
Slovenian: „(c) Agencija nemudoma:
English: (c) the names of all participants in meetings of the Scientific Committee and the Scientific Panels and their Working Groups.
Slovenian: (c) imena vseh udeležencev zasedanj znanstvenega odbora in znanstvenih svetov ter njihovih delovnih skupin;
English: 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.
Slovenian: V predlogu je predlagano, da se Komisija pooblasti, da z delegiranimi akti pripravi ta splošni načrt za namene Uredbe (ES) št. 178/2002.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: (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.
Slovenian: (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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: "(c) The Authority shall:
Slovenian: „(c) Agencija:
English: Strengthen advocacy: targeted messages, narrative, translations etc 4.8 FTEs 0.248 0.434 0.620
Slovenian: Krepitev zagovorništva: ciljna sporočila, predstavitve, prevodi itd. 4,8 EPDČ 0,248 0,434 0,620
English: Heading of multiannual financial
Slovenian: Razdelek večletnega finančnega
English: (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;
Slovenian: (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;
English: 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.
Slovenian: Ta predlog določa redno splošno oceno agencije, ki jo naroči Komisija na podlagi skupnega pristopa k decentraliziranim agencijam.
English: The non-confidential version shall be without the information the applicant deems confidential in accordance with paragraphs 2 and 3 of Article 39.
Slovenian: Nezaupna različica ne vsebuje informacij, ki jih vlagatelj v skladu z odstavkoma 2 in 3 člena 39 šteje za zaupne.
English: 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".
Slovenian: Prav tako pripisuje stalno pomembnost kakovosti in neodvisnosti znanstvenih študij, na katerih temelji ocenjevanje tveganja na ravni EU, ki ga izvaja EFSA.
English: Decision on confidentiality
Slovenian: Odločitev o zaupnosti
English: The applicant shall clearly indicate the grounds on the basis of which confidentiality is requested for the different pieces of information.
Slovenian: Vlagatelj jasno navede razloge, zaradi katerih zahteva zaupnost posameznih informacij.
English: The Commission will bear the limited costs.
Slovenian: Stroški so omejeni, krila pa jih bo Komisija.
English: 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.
Slovenian: Informacije o priglašenih študijah bi bilo treba objaviti šele po objavi ustrezne vloge za odobritev v skladu z veljavnimi pravili o preglednosti.
English: 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;
Slovenian: poostritve in pojasnitve pravil o preglednosti, zlasti glede znanstvenih študij, uporabljenih kot podlaga za oceno tveganja, ki jo opravi EFSA;
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: (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.
Slovenian: (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.
English: (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.
Slovenian: (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.
English: Amendments to Regulation (EC) No 1829/2003 on genetically modified food and feed
Slovenian: Spremembe Uredbe (ES) št. 1829/2003 o gensko spremenjenih živilih in krmi
English: 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.
Slovenian: Izboljšanje preglednosti študij in obravnavanje družbenih pomislekov za preglednejši in bolj neodvisen postopek ocenjevanja tveganja ter učinkovitejše obveščanje o tveganju.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Komisija in države članice sprejmejo tudi potrebne ukrepe, da ne objavijo informacij, za katere je agencija odobrila zaupno obravnavo.
English: (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.
Slovenian: (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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Amendments to Regulation (EC) No 1935/2004 on Food Contact Materials
Slovenian: Spremembe Uredbe (ES) št. 1935/2004 o materialih, namenjenih za stik z živili
English: 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.
Slovenian: 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.
English: Contract agents Year
Slovenian: Pogodbeni uslužbenci Leto
English: Seconded National Experts Year
Slovenian: Napoteni nacionalni strokovnjaki Leto
English: [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.]
Slovenian: [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.
English: 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:
Slovenian: Agencija lahko odobri samo zaupno obravnavo naslednjih informacij, katerih razkritje bi lahko na podlagi preverljive utemeljitve znatno škodovalo zadevnim interesom:
English: IT support for data disclosure Licences/maintenance/storage/security 0.960 1.680 2.400 2.400 2.400 9.840
Slovenian: Informacijska podpora za objavljanje podatkov Licence/vzdrževanje/shranjevanje/varnost 0,960 1,680 2,400 2,400 2,400 9,840
English: (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.
Slovenian: (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.
English: 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.
Slovenian: 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.
English: (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.
Slovenian: (18) Agencija bi morala poznati predmet vseh študij, ki jih izvede vlagatelj v zvezi s prihodnjo vlogo za odobritev na podlagi živilske zakonodaje Unije.
English: 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.
Slovenian: 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.
English: Subtotal for specific objective No 4 2.800 4.900 7.000 7.000 7.000 28.700
Slovenian: Seštevek za specifični cilj št. 4 2,800 4,900 7,000 7,000 7,000 28,700
English: (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.
Slovenian: (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.
English: (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.
Slovenian: (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.
English: "Article 57a
Slovenian: „Člen 57a
English: Taking into account the respective roles of risk assessors and risk managers, risk communication shall:
Slovenian: Ob upoštevanju vlog odgovornih za oceno tveganja in odgovornih za obvladovanje tveganja mora obveščanje o tveganju:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Verification studies
Slovenian: Preveritvene študije
English: 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.
Slovenian: 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.
English: (b) Member States shall nominate experts with a view to collectively reach the number indicated by the Executive Director.
Slovenian: (b) Države članice predlagajo strokovnjake, njihovo skupno število pa mora doseči število, ki ga navede izvršni direktor.
English: 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").
Slovenian: 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").
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Amendments to Regulation (EC) 1831/2003 on feed additives
Slovenian: Spremembe Uredbe (ES) 1831/2003 o krmnih dodatkih
English: (a) agendas and minutes of the Scientific Committee and the Scientific Panels and their Working Groups;
Slovenian: (a) dnevne rede in zapisnike zasedanj znanstvenega odbora in znanstvenih svetov ter njihovih delovnih skupin;
English: Obligations with regard to confidentiality
Slovenian: Obveznosti glede zaupnosti
English: (b) the competent authority shall assess the confidentiality request submitted by the notifier/applicant.
Slovenian: (b) pristojni organ oceni zahtevo za zaupnost, ki jo je predložil prijavitelj/vlagatelj.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: (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.
Slovenian: (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.
English: Review clause
Slovenian: Klavzula ponovnega pregleda
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY
Slovenian: trajanje predloga/pobude od [D. MMMM] LLLL do [D. MMMM] LLLL,
English: A decision to revoke shall put an end to the delegation of power specified in that decision.
Slovenian: S sklepom o preklicu preneha veljati prenos pooblastila iz navedenega sklepa.
English: Amendments to Regulation (EC) No 1331/2008 on the common authorisation procedure for food additives, food enzymes and food flavourings
Slovenian: Spremembe Uredbe (ES) št. 1331/2008 o skupnem postopku odobritve za aditive za živila, encime za živila in arome za živila
English: "The Authority shall ensure public access to the notification pursuant to Article 23.
Slovenian: „Agencija v skladu s členom 23 zagotovi javni dostop do priglasitve.
English: SPECIFIC OBJECTIVE No 4 develop a more effective and transparent risk communication with the public in collaboration with Member States
Slovenian: SPECIFIČNI CILJ št. 4 razviti učinkovitejše in preglednejše obveščanje javnosti o tveganju v sodelovanju z državami članicami
English: Risk assessment is defined as the scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation.
Slovenian: Ocena tveganja je opredeljena kot postopek na znanstveni podlagi, sestavljen iz štirih korakov: prepoznavanja nevarnosti, opredelitve nevarnosti, ocene izpostavljenosti in opredelitve tveganja.
English: Strengthened analysis of social science survey analysis 0.500 0.875 1.250 1.250 1.250 5.125
Slovenian: Okrepljena analiza: družboslovne raziskave, analize 0,500 0,875 1,250 1,250 1,250 5,125
English: 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.
Slovenian: Kadar mnenje Agencije v skladu s členom 3(2) te uredbe ni potrebno, Komisija oceni zahtevo za zaupnost, ki jo je vložil predlagatelj.
English: 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
Slovenian: SPECIFIČNI CILJ št. 3 izboljšati upravljanje, okrepiti vključenost držav članic ter odpraviti omejitve, ki vplivajo na dolgoročno znanstveno zmogljivost agencije EFSA
English: Officials (AD Grades)
Slovenian: Uradniki (razredi AD)
English: Estimated impact on the staff (additional) - external personnel
Slovenian: Ocenjene posledice za uslužbence (dodatno) - zunanji sodelavci
English: 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.
Slovenian: 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.
English: Regulation (EU) No 2015/2283 is amended as follows:
Slovenian: Uredba (EU) 2015/2283 se spremeni:
English: 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.
Slovenian: 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.
English: Amendments to Regulation (EC) No 2065/2003 on smoke flavourings
Slovenian: Spremembe Uredbe (ES) št. 2065/2003 o aromah dima
English: Additional ad hoc studies 16 ad hoc studies 6.000 10.500 15.000 15.000 15.000 61.500
Slovenian: Dodatne študije ad hoc 16 študij ad hoc 6,000 10,500 15,000 15,000 15,000 61,500
English: 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.
Slovenian: Ta nujni predlog temelji na ugotovitvah preverjanja ustreznosti uredbe o splošni živilski zakonodaji in na zavezah iz odgovora Komisije na evropsko državljansko pobudo.
English: (b) the following paragraphs 1a and 1b are inserted:
Slovenian: (b) vstavita se naslednja odstavka 1a in 1b:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Kadar Komisija v skladu s členoma 10 in 16 Agencije ne zaprosi za mnenje, Komisija oceni zahtevo za zaupnost, ki jo je predložil vložnik.
English: NO YES
Slovenian: /NE DA
English: There should be no negative impact for innovation from the measures on the reliability and robustness of studies.
Slovenian: Ukrepi za zanesljivost in trdnost študij ne bi smeli negativno vplivati na inovacije.
English: Capacity building 2.4 FTEs 0.124 0.217 0.310
Slovenian: Krepitev zmogljivosti 2,4 EPDČ 0,124 0,217 0,310
English: [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.
Slovenian: [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.
English: 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.
Slovenian: 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.
English: (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.
Slovenian: (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.
English: Temporary staff 4.861 8.507 12.154 12.154 12.154 49.830
Slovenian: Začasni uslužbenci 4,861 8,507 12,154 12,154 12,154 49,830
English: 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,
Slovenian: 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;
English: Subtotal for specific objective No 1 1.120 1.960 2.800 2.800 2.800 11.480
Slovenian: Seštevek za specifični cilj št. 1 1,120 1,960 2,800 2,800 2,800 11,480
English: (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.
Slovenian: (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.
English: 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.
Slovenian: 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.
English: (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.
Slovenian: (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.
English: 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.
Slovenian: 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.
English: Additional ad hoc studies 4FTEs 0.207 0.362 0.517
Slovenian: Dodatne študije ad hoc 4 EPDČ 0,207 0,362 0,517
English: (b) the Authority shall assess the confidentiality request submitted by the applicant.
Slovenian: (b) Agencija oceni zahtevo za zaupnost, ki jo je predložil vlagatelj.
English: (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,
Slovenian: (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
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Estimated impact on EFSA expenditure
Slovenian: Ocenjene posledice za odhodke EFSA
English: "Article 39
Slovenian: „Člen 39
English: Capacity building 10 panels/21 members 7 days/training /y 0.224 0.392 0.560 0.560 0.560 2.296
Slovenian: Krepitev zmogljivosti 10 svetov/21 članov 7 dni usposabljanja/leto 0,224 0,392 0,560 0,560 0,560 2,296
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.";
English: [Heading……………………...…………] Diff./Non-diff.[44: Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.]
Slovenian: [44: Dif. = diferencirana sredstva / nedif.
English: [16: Commission Staff Working Document, Synopsis Report, SWD(2018)97, [dated 11.04.2018].]
Slovenian: [16: Delovni dokument služb Komisije, Zbirno poročilo, SWD(2018) 97, [z dne 11. 4.
English: 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.
Slovenian: 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.