natgillin/translations-raw huggingface dataset:
The members of the Management Board and where relevant, the alternate members shall be appointed taking into account high competence in the area of food safety risk assessment as well as competences in the food chain safety legislation and policy, and relevant managerial, administrative and budgetary/financial skills.
Člani upravnega odbora in, kadar je ustrezno, nadomestni člani so imenovani na podlagi visoke usposobljenosti na področju ocenjevanja tveganja v zvezi z varnostjo hrane, pa tudi znanja na področju zakonodaje o varnosti prehranske verige in s tem povezane politike ter ustreznih vodstvenih, upravnih in proračunskih/finančnih sposobnosti.
EFSA's independence will not be affected to any extent since the scope of the advice that EFSA provides is limited to what the relevant provisions are and what the required content of the application at stake is.
Neodvisnost agencije EFSA ne bo v nobenem smislu ogrožena, saj je svetovanje agencije EFSA omejeno na zadevne določbe in na zahtevano vsebino zadevne vloge.
By way of derogation from Article 38, the Authority shall not make public information for which confidential treatment has been requested under the conditions laid down in this Article.
Z odstopanjem od člena 38 agencija ne objavi informacij, za katere se zahteva zaupna obravnava pod pogoji iz tega členu.
Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market.
Poleg tega se javna sredstva ne bi smela uporabljati za naročanje dragih študij, ki bodo na koncu industriji pomagale dati izdelek na trg.
As explained in the Roadmap, no impact assessment was carried out for this initiative, as the measures that are to be introduced by the proposal will mainly concern the transparency and the way the Commission as risk manager and the EFSA as risk assessor will gather and manage the evidence needed to perform their tasks on the basis of unchanged criteria.
Kot je pojasnjeno v časovnem načrtu, za to pobudo ni bila izvedena ocena učinka, saj se bodo ukrepi, ki bodo uvedeni s predlogom, v glavnem nanašali na preglednost in način, kako Komisija kot odgovorna za obvladovanje tveganja in EFSA kot odgovorna za oceno tveganja na podlagi nespremenjenih meril zbirata in obravnavata dokaze, potrebne za opravljanje njunih nalog.
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").
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").
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:
Člane znanstvenih svetov imenuje upravni odbor za petletni mandat z možnostjo podaljšanja v skladu z naslednjim postopkom:
Impact assessment
Ocena učinka
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.
Države članice zagotovijo, da lahko člani znanstvenih svetov posvetijo dovolj časa in truda delu agencije.
Further measures should also be put in place to ensure that scientific experts have the means to act independently.
Vzpostaviti bi bilo treba tudi dodatne ukrepe, ki bodo omogočili neodvisno delovanje znanstvenih strokovnjakov.
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.
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.
(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 […],
(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 […] -
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.
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.
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.
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.
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.
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.
The process to be followed for the processing of confidentiality claims is also set up.
Prav tako je določen postopek za obravnavo zahtev za zaupnost.
EFSA Single Programming Document (SPD), EFSA Management Board meeting (responsible for Authority's governance), EFSA Annual report activities.
Enotni programski dokument agencije EFSA, seja upravnega odbora agencije EFSA (odgovornega za upravljanje agencije EFSA), dejavnosti, povezane z letnim poročilom agencije EFSA.
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.
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.
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.
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.
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.
V ta namen predlog določa medsektorski seznam informacij, katerih razkritje bi lahko znatno škodovalo zadevnim poslovnim interesom, zato se ne bi smele razkriti javnosti.
Consistency with existing policy provisions in the policy area
Skladnost z veljavnimi predpisi s področja zadevne politike
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).
Komisija takoj obvesti države članice in posreduje zahtevek Evropski agenciji za varnost hrane (v nadaljnjem besedilu: urad).
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.
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.
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.
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.
The members and alternate members thus nominated shall be appointed by the Council and have voting rights.
Tako predlagane člane in nadomestne člane imenuje Svet in imajo glasovalno pravico.
(b) The following paragraphs 5a to 5g are inserted:
(b) vstavijo se naslednji odstavki 5a do 5g:
The relevant items shall be available to download, print and search through in an electronic format.
Zadevni dokumenti so v elektronski obliki na voljo za prenos, tisk in iskanje.
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.
Na zahtevo morebitnega vlagatelja vloge za odobritev na podlagi živilske zakonodaje osebje agencije svetuje o zadevnih določbah in potrebni vsebini vloge za odobritev.
For the adoption of standard data formats and software packages the following procedure shall be followed:
Standardne oblike zapisa podatkov in paketi programske opreme se sprejmejo po naslednjem postopku:
It will help applicants in particular small and medium sized enterprises in understanding how to prepare authorisation applications.
Vložniki, zlasti mala in srednja podjetja, bodo lažje razumela, kako je treba pripraviti vloge za odobritev.
(2) Regulation (EC) No 178/2002 defines "risk analysis" as a process consisting of three interconnected components: risk assessment, risk management and risk communication.
(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.
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.
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.
(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;
(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;
The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication.
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.
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.
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.
The risk analysis principle consists of three separate but interconnected components: risk assessment, risk management and risk communication.
Načelo analize tveganja je sestavljeno iz treh ločenih, a medsebojno povezanih sestavnih delov: ocene tveganja, obvladovanja tveganja in obveščanja o tveganju.
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."
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.
Estimated impact on the staff (additional FTE) - establishment plan
Ocenjene posledice za osebje (dodatni EPDČ) - kadrovski načrt
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.
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.
The confidential version shall contain all information submitted, including information the applicant deems confidential.
Zaupna različica vsebuje vse predložene informacije, vključno z informacijami, ki jih vlagatelj šteje za zaupne.
[1) improve and clarify the rules on transparency, especially with regard to the scientific studies supporting the risk assessment;
[1) izboljšati in pojasniti pravila o preglednosti, zlasti glede znanstvenih študij v podporo oceni tveganja;
(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).
(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.
It ensures that action can be taken at Union level where there are exceptional circumstances of serious controversies or conflicting results.
Zagotavlja, da je mogoče ukrep v izrednih okoliščinah - če gre za sporna vprašanja ali nasprotujoče si rezultate - sprejeti na ravni Unije.
Regulatory fitness and simplification
Ustreznost in poenostavitev ureditve
The transparency provisions are without prejudice to any existing Intellectual Property Rights and data exclusivity provisions set out in Union sectoral food legislation.
Določbe o preglednosti ne posegajo v obstoječe pravice intelektualne lastnine in določbe o izključnosti podatkov iz sektorske živilske zakonodaje Unije.
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.
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.
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.
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.
Amendments to Regulation (EU) No 2015/2283 on novel foods
Spremembe Uredbe (EU) 2015/2283 o novih živilih
EFSA provides the advice in a transparent way since it makes it public.
Svetovanje agencije EFSA je pregledno, saj je na voljo javnosti.
(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,
(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
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.
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.
Officials (AST grades)
Uradniki (razredi AST)
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.
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.
Seconded National Experts
Napoteni nacionalni strokovnjaki
(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.
(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.
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.
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.
(i) advice provided by the Authority to potential applicants at pre-submission phase pursuant to Article 32a and 32c.
(i) mnenje, ki ga agencija predloži morebitnim vlagateljem pred vložitvijo vloge v skladu s členoma 32a in 32c.
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.
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.
(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,
(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
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.
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.
YES NO NO NO
NE DA/NE