natgillin/translations-raw huggingface dataset:
(21) Studies, including tests, submitted by business operators in support of applications for authorisations under Union sectoral food law usually comply with internationally recognised principles, which provide a uniform basis for their quality in particular in terms of reproducibility of results. 
(21) Študije, vključno s preizkusi, ki jih predložijo nosilci dejavnosti v podporo vlogam za odobritev na podlagi sektorske živilske zakonodaje Unije, so običajno v skladu z mednarodno priznanimi načeli, ki zagotavljajo enotno podlago za njihovo kakovost, zlasti z vidika ponovljivosti rezultatov.
There is no risk of duplication with the actual capacity of EFSA to commission scientific studies necessary for the performance of its mission (Article 32 of the GFL Regulation) as this is to be considered as a risk management tool. 
Ni tveganja, da bi prišlo do podvajanja dela z dejansko nalogo agencije EFSA, da naroči znanstvene študije, potrebne za izvajanje svojega poslanstva (člen 32 uredbe o splošni živilski zakonodaji), saj se to orodje obravnava kot orodje za obvladovanje tveganja.
(b) all its scientific outputs, including the opinions of the Scientific Committee and the Scientific Panels after adoption, minority opinions and results of consultations performed during the risk assessment process always being included; 
(b) vse svoje znanstvene prispevke, vključno z mnenji znanstvenega odbora in znanstvenih svetov po njihovem sprejetju, pri čemer vedno priloži manjšinska mnenja in rezultate posvetovanj, opravljenih med postopkom ocenjevanja tveganja;
Nevertheless, the following challenges have been identified: national differences in the implementation of the GFL Regulation at Member State level have been observed, creating in some instances uneven playing field for businesses; a perceived lack of transparency of the risk analysis process; risk communication is, overall, considered not to be effective enough, thus creating a negative impact on consumers' confidence and on the acceptability of risk management decisions; certain limitations in EFSA's capacity to ensure in the long-term sufficient expertise and to fully engage all Member States in scientific cooperation; lengthy authorisation procedures in some sectors. 
Kljub temu pa so bili opredeljeni naslednji izzivi: opažene so bile nacionalne razlike pri izvajanju uredbe o splošni živilski zakonodaji na ravni držav članic, kar v nekaterih primerih ustvarja neenake konkurenčne pogoje za podjetja; postopek analize tveganja se dojema kot ne dovolj pregleden; obveščanje o tveganju na splošno velja za ne dovolj učinkovito, kar ustvarja negativen učinek na zaupanje potrošnikov in na sprejemljivost odločitev o obvladovanju tveganja; nekatere omejitve zmogljivosti agencije EFSA za dolgoročno zagotavljanje ustreznega strokovnega znanja in pritegnitev vseh držav članic k znanstvenemu sodelovanju; dolgotrajni postopki odobritve v nekaterih sektorjih.
The Executive Director shall notify the Member States of the Authority's independence policy and implementing rules applicable to Scientific Panels' members. 
Izvršni direktor obvesti države članice o politiki neodvisnosti agencije in izvedbenih pravilih, ki se uporabljajo za člane znanstvenih svetov.
To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned. 
Zato je potrebno in primerno, da nosilci dejavnosti, ki naročijo študije, in laboratoriji, ki te študije izvajajo, študije ob naročilu priglasijo Agenciji.
These can be explained by a variety of factors including for instance: the legal framework to which the question refers, the type of question put to scientific bodies by the relevant risk managers and how these are framed, whether the assessment relates to a hazard or a risk, the methodologies followed, or the data, which are utilised. 
To je mogoče pojasniti z več dejavniki, med drugim: s pravnim okvirom, na katerega se nanaša vprašanje; z vrsto vprašanja, ki ga zadevni odgovorni za obvladovanje tveganja predložijo znanstvenim organom, ter način njegovega oblikovanja; ali se ocena nanaša na nevarnost ali tveganje; z uporabljenimi metodologijami ali podatki.
Amendments to Directive (EC) 2001/18/EC on the deliberate release into the environment of genetically modified organisms 
Spremembe Direktive 2001/18/ES o namernem sproščanju gensko spremenjenih organizmov v okolje
(b) any provisions set out in Union food law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations (‘data exclusivity rules'). 
(b) katere koli določbe iz živilske zakonodaje Unije, ki ščitijo naložbe inovatorjev v zbiranje informacij in podatkov v podporo zadevnim vlogam za odobritev („pravila o izključnosti podatkov").
[24: Communication from the Commission on the ECI "Ban glyphosate and protect people and the environment from toxic pesticides", C(2017) 8414 final.] 
[24: Sporočilo Komisije o evropski državljanski pobudi „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi", C(2017) 8414 final.]
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