natgillin/translations-raw huggingface dataset:
(10) It is appropriate to align the composition of the Management Board of the Authority to the Common Approach on decentralised agencies, in accordance with the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies of 2012.
(10) Sestavo upravnega odbora Agencije je primerno uskladiti s skupnim pristopom k decentraliziranim agencijam, v skladu s skupno izjavo Evropskega parlamenta, Sveta Evropske unije in Evropske komisije o decentraliziranih agencijah iz leta 2012.
At the same time, the proposal is expected to ensure the long-term sustainability of EFSA's capacity of scientific expertise.
S predlogom pa naj bi hkrati zagotovili dolgoročno trajnost zmogljivosti agencije EFSA za ohranjanje strokovnega znanja.
Given the targeted nature of this revision, focussing on transparency, the main simplification aspect concerns the introduction of a pre-submission advice which should provide support to applicants, in particular SMEs, to better understand the specifications on content of applications.
Ker je ta revizija usmerjena v preglednost, se glavni vidik poenostavitve nanaša na uvedbo svetovanja pred vložitvijo vloge, s katerim bi se morala zagotoviti podpora vlagateljem, zlasti MSP, da bi bolje razumeli specifikacije glede vsebine vlog.
(4) quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion.
(4) kvantitativne sestave predmeta, na katerega se nanaša zaprosilo za znanstveni prispevek, vključno z znanstvenim mnenjem.
Recent debates raised concerns on transparency and independence of industry-generated studies and data.
V nedavnih razpravah so bili izraženi pomisleki glede preglednosti in neodvisnosti študij in podatkov industrije.
(b) specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment.
(b) specifikacij nečistoč aktivne snovi in ustreznih metod analize, ki jih je vložnik interno razvil, razen nečistoč, ki bi lahko imele škodljive učinke na zdravje živali, zdravje ljudi ali okolje.
The EFSA's effectiveness depends on its capacity to attract and pool expertise from Member States.
Učinkovitost agencije EFSA je odvisna od njene zmožnosti, da pritegne in združi strokovno znanje iz držav članic.
The Authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment.
Agencija že pregleduje znanstveno literaturo, da bi lahko upoštevala druge podatke in študije o predmetu, na katerega se nanaša njena ocena.
[19: OJ C , , p.
[19: UL C , , str.
(iii) Meeting the needs for the specific multi-disciplinary expertise of the Panel to which they will be appointed and the applicable language regime.
(iii) izpolnjevanje potreb po posebnih večdisciplinarnih strokovnih znanjih znanstvenega sveta, v katerega bodo imenovani, in potreb veljavne jezikovne ureditve.
(b) provide transparent information at each stage of the risk analysis process from the framing of requests for scientific advice to the provision of risk assessment and the adoption of risk management decisions;
(b) zagotavljati pregledne informacije na vsaki stopnji postopka analize tveganja, od oblikovanja zaprosil za znanstveno mnenje do predložitve ocene tveganja in sprejetja odločitev o obvladovanju tveganja;
For the purposes of risk assessment at Union level, it establishes the European Food Safety Authority ("the Authority"), as the responsible Union risk assessment body in matters relating to food and feed safety.
Za namene ocene tveganja na ravni Unije ustanavlja Evropsko agencijo za varnost hrane (v nadaljnjem besedilu: Agencija) kot pristojni organ Unije za ocenjevanje tveganja glede zadev, povezanih z varnostjo hrane in krme.
(13) The Fitness Check of the General Food Law identified certain shortcomings in the long-term capability of the Authority to maintain its high-level expertise.
(13) Pri preverjanju ustreznosti splošne živilske zakonodaje so bile ugotovljene nekatere pomanjkljivosti pri dolgoročni zmogljivosti Agencije za ohranjanje strokovnega znanja na visoki ravni.
The GFL Fitness Check and recent public debates have shown that certain aspects of the current legislative framework need to be addressed.
Pri preverjanju ustreznosti splošne živilske zakonodaje in v nedavnih javnih razpravah se je pokazalo, da je treba obravnavati nekatere vidike sedanjega zakonodajnega okvira.
(30) It is also necessary to set out specific requirements with respect to the protection of personal data for the purposes of the transparency of the risk assessment process taking into account Regulation (EC) No 45/2001 of the European Parliament and of the Council and Regulation (EU) 2016/679 of the European Parliament and of the Council.
(30) Prav tako je treba določiti posebne zahteve v zvezi z varstvom osebnih podatkov za namene preglednosti postopka ocenjevanja tveganja ob upoštevanju Uredbe (ES) št. 45/2001 Evropskega parlamenta in Sveta in Uredbe (EU) 2016/679 Evropskega parlamenta in Sveta.
The option having Member States requesting EFSA to commission studies in exceptional circumstances as well as the option having EFSA commissioning such studies on its own motion were not chosen in the end for reasons of proportionality (public financing) but also because the EFSA and Member States can already signal to the Commission specific reasons to make use of this specific tool.
Možnost, da lahko države članice od agencije EFSA zahtevajo, da naroči študije v izjemnih okoliščinah, ter možnost, da lahko EFSA naroča take študije na lastno pobudo, na koncu nista bili izbrani zaradi sorazmernosti (javno financiranje), pa tudi zato, ker lahko EFSA in države članice že zdaj Komisijo opozorijo na posebne razloge za uporabo tega specifičnega orodja.
Those arrangements shall however be in accordance with the present Regulation and other Union sectoral food law.
Navedena ureditev je v skladu s to uredbo in drugo sektorsko živilsko zakonodajo Unije.
EFSA has in place and strictly monitors its rules on "independence" and "conflict of interest"; Control method(s) envisaged
EFSA ima vzpostavljena pravila o „neodvisnosti" in „nasprotju interesov", ki jih pozorno spremlja; načrtovani načini kontrole
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Inter-institutional Agreement on Better Law-Making of 13 April 2016.
Komisija se pred sprejetjem delegiranega akta posvetuje s strokovnjaki, ki jih imenuje posamezna država članica, v skladu z načeli iz Medinstitucionalnega sporazuma o boljši pripravi zakonodaje z dne 13. aprila 2016.
(7) the following Articles 39a to 39g are inserted:
(7) vstavijo se naslednji členi 39a do 39g:
Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.
Navedite, kakšne posledice naj bi imel(-a) predlog/pobuda za upravičence/ciljne skupine.
The impetus for the GFL Regulation came from a succession of food related crises, notably the Bovine Spongiform Encephalopathy (BSE) crisis, foot and mouth disease and dioxin in the late 90s-early 2000s.
Povod za uredbo o splošni živilski zakonodaji je bila vrsta prehranskih kriz v poznih devetdesetih letih 20. in v začetku 21. stoletja, zlasti kriza v zvezi z govejo spongiformno encefalopatijo (BSE), slinavko in parkljevko ter dioksinom.
The term of office of the members referred to in paragraph 1a(c) may be renewable only once.
Mandat članov iz odstavka 1a(c) se lahko samo enkrat podaljša.
(3) The evaluation of Regulation (EC) No 178/2002, ("Fitness Check of the General Food Law"), found that risk communication is overall, not considered to be effective enough, which has an impact on consumers' confidence on the outcome of the risk analysis process.
(3) Pri oceni Uredbe (ES) št. 178/2002 („preverjanje ustreznosti splošne živilske zakonodaje") je bilo ugotovljeno, da se obveščanje o tveganju na splošno ne šteje za dovolj učinkovito, kar vpliva na zaupanje potrošnikov v rezultat postopka analize tveganja.
[20: OJ C , , p.
[20: UL C , , str.
(39) The appointment of the Scientific Committee and Scientific Panels' members being dependent of the entry in function of the new Management Board, it is necessary to provide for specific transitional provisions allowing a prolongation of the current term of office of the members of the Scientific Committee and Scientific Panels members.
(39) Ker je imenovanje članov znanstvenega odbora in znanstvenih svetov odvisno od začetka delovanja novega upravnega odbora, je treba določiti posebne prehodne določbe, ki omogočajo podaljšanje sedanjega mandata članov znanstvenega odbora in znanstvenih svetov.
With respect to requests for scientific outputs, including scientific opinions under Union food law, the Authority shall always make public:
V zvezi z zaprosili za znanstvene prispevke, med drugim tudi za znanstvena mnenja na podlagi živilske zakonodaje Unije, agencija vedno objavi:
The consultation on submitted studies does not create additional burdens since the obligation to submit studies to EFSA, Commission and Member States already exists.
Posvetovanje o predloženih študijah ne bo povzročilo dodatnega bremena, saj že obstaja obveznost predložitve študij agenciji EFSA, Komisiji in državam članicam.
(a) identify the key factors that need to be taken into account when considering the type and level of risk communications' activities needed;
(a) opredeljeni ključni dejavniki, ki jih je treba upoštevati pri določanju vrste in ravni potrebnih dejavnosti obveščanja o tveganju;
Regulation (EC) No 178/2002 on general food law (the "GFL" Regulation) provides for a comprehensive harmonised legal framework.
Uredba (ES) št. 178/2002 o splošni živilski zakonodaji („uredba o splošni živilski zakonodaji") določa celovit in usklajen pravni okvir.
Alternatives considered:
Obravnavane alternativne možnosti:
The risk that some Member States might not have enough experts to be able to provide the EFSA with valuable candidates is alleviated by the possibility for EFSA to select and appoint additional experts of its own accord and the possibility for Member States to appoint experts who have the nationality of other Member States.
Tveganje, da nekatere države članice morda nimajo dovolj strokovnjakov, da bi lahko agenciji EFSA zagotovile ustrezne kandidate, se izravna z možnostjo, da lahko EFSA sama izbere in imenuje dodatne strokovnjake, ter možnostjo, da države članice imenujejo strokovnjake z državljanstvom druge države članice.
The Executive Director may not draw up such a list where he/she can justify that the nominations received do not allow him, given the criteria for selection set up in point d) of this paragraph, to draw up a larger list.
Izvršni direktor ne sme pripraviti takega seznama, kadar lahko utemelji, da na podlagi prejetih predlogov ne more pripraviti daljšega seznama glede na merila za izbor iz točke (d) tega odstavka.
On transparency, the measures envisaged (i.e. proactive disclosure of non-confidential data, register of commissioned studies, voluntary pre-submission procedure, pre-notification of, and advice on planned studies in case of renewals, consultation of third parties on submitted studies) provide a robust framework which is proportional to the objective of enhancing citizens' confidence in the transparency of the system.
Kar zadeva preglednost, se s predvidenimi ukrepi (na primer proaktivno razkritje nezaupnih podatkov, register naročenih študij, prostovoljni postopek pred vložitvijo vloge, predhodno obveščanje in svetovanje o načrtovanih študijah v primeru obnovitev, posvetovanje s tretjimi osebami o predloženih študijah) vzpostavlja trden okvir, ki je sorazmeren s ciljem krepiti zaupanje državljanov v preglednost sistema.
(37) In order to further strengthen the link between risk assessors and risk managers at Union and national levels as well as the coherence and consistency of risk communication, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to adopt a general plan on risk communication on matters covering the agri-food chain.
(37) Da bi še dodatno okrepili povezavo med odgovornimi za oceno tveganja in odgovornimi za obvladovanje tveganja na ravni Unije in nacionalnih ravneh ter skladnost in doslednost obveščanja o tveganju, bi bilo treba na Komisijo prenesti pooblastilo, da v skladu s členom 290 Pogodbe sprejme akte za sprejetje splošnega načrta za obveščanje o tveganju glede zadev, povezanih z agroživilsko verigo.
It is appropriate to lay down in Regulation (EC) No 178/2002 a horizontal list of information items whose disclosure may be considered to significantly harm the commercial interests concerned and should not therefore be disclosed to the public, ("general horizontal list of confidential items").
V Uredbi (ES) št. 178/2002 je primerno določiti horizontalni seznam informacij, katerih razkritje bi lahko veljalo za zelo škodljivo za zadevne poslovne interese in ki se zato ne bi smele razkriti javnosti („splošni horizontalni seznam zaupnih postavk").
There are still strong memories of the damage caused by successive food safety crises prior to the GFL Regulation which undermined the credibility of the Union to ensure that food is safe.
Še dobro pomnijo škodo, ki so jo povzročile številne krize na področju varnosti hrane spred sprejetjem uredbe o splošni živilski zakonodaji, ki so omajale verodostojnost Unije, da je zmožna zagotavljati varno hrano.
These developments took place against the backdrop of public controversy over the approach towards the assessment and management of sensitive substances such as genetically modified organisms, and plant protection products, especially those containing glyphosate or potentially negative health impacts arising from endocrine disruptors.
To dogajanje je sovpadalo z javno polemiko glede pristopa k ocenjevanju občutljivih snovi in ravnanju z njimi, na primer gensko spremenjenih organizmov in fitofarmacevtskih sredstev, zlasti tistih, ki vsebujejo glifosat ali imajo potencialno negativne učinke na zdravje, ki jih povzročajo endokrini motilci.
The Executive Director shall inform the Management Board of the requests sent to the Member States.
Izvršni direktor obvesti upravni odbor o zaprosilih, poslanih državam članicam.
XX 01 04 yy[50: Sub-ceiling for external staff covered by operational appropriations (former ‘BA' lines).]
XX 01 04 yy[50: Dodatna zgornja meja za zunanje sodelavce v okviru odobritev za poslovanje (prej vrstice BA).]
Function group and grade Year
Funkcionalna skupina in razred Leto
Citizens / civil society perceive the risk assessment process as opaque and demand more transparency, due to several different transparency and confidentiality rules applicable to risk assessment and decision-making process, making the system complex and non-uniform.
Državljani/civilna družba postopek ocenjevanja tveganja dojemajo kot nepregleden in zahtevajo večjo preglednost zaradi različnih pravil o preglednosti in zaupnosti, ki se uporabljajo za postopek ocenjevanja tveganja in odločanja, zaradi česar je sistem zapleten in neenoten.
The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests.
Pri oceni bi bilo zlasti treba pregledati postopke za izbor članov znanstvenega odbora in svetov, njihovo stopnjo preglednosti, stroškovno učinkovitost in primernost, da se zagotovita neodvisnost in usposobljenost ter preprečijo nasprotja interesov.
The list of information referred to in paragraph 2 shall be without prejudice to any specific Union food law.
Seznam informacij iz odstavka 2 ne posega v nobeno posebno živilsko zakonodajo Unije.
It is therefore essential to maintain the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation and independence of the Authority and transparency.
Zato je bistveno ohraniti zaupanje splošne javnosti in drugih zainteresiranih strani v postopek analize tveganja, na katerem temelji živilska zakonodaja Unije, in zlasti v ocenjevanje tveganja, vključno z organizacijo in neodvisnostjo Agencije ter preglednostjo.
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, and 168(4)(b) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti člena 43, člena 114 in člena 168(4)(b) Pogodbe,
The Commission, in close cooperation with the Authority, the Member States and following appropriate public consultations shall be empowered to adopt delegated acts in accordance with Article 57a establishing a general plan for risk communication on matters relating to the agri-food chain, taking into account the relevant objectives and general principles set out in Articles 8a and 8b.
Komisija je v skladu s členom 57a pooblaščena, da v tesnem sodelovanju z agencijo, državami članicami in po ustreznih javnih posvetovanjih sprejme delegirane akte o določitvi splošnega načrta obveščanja o tveganju glede zadev v zvezi z agroživilsko verigo, ob upoštevanju zadevnih ciljev in splošnih načel iz členov 8a in 8b.
Indeed, the science-based approach to food legislation, underpinned by the establishment and operation of EFSA at centralised level, has overall improved the scientific basis of measures taken in the area of food law and has further contributed to harmonised views between Member States on key safety issues as well as to the Union product safety recognition worldwide.
Dejansko se je s znanstvenim pristopom k živilski zakonodaji, ki je temeljil na ustanovitvi in delovanju agencije EFSA na centralizirani ravni, na splošno izboljšala znanstvena podlaga za ukrepe, sprejete na področju živilske zakonodaje, prispeval pa je tudi k nadaljnji uskladitvi stališč med državami članicami o ključnih varnostnih vprašanjih ter k mednarodnemu priznanju varnosti proizvodov v Uniji.
persons entrusted with the implementation of specific actions in the CFSP pursuant to Title V of the TEU, and identified in the relevant basic act.
osebam, pooblaščenim za izvajanje določenih ukrepov SZVP v skladu z naslovom V PEU in opredeljenim v zadevnem temeljnem aktu.
Amendments to Regulation (EC) No 178/2002
Spremembe Uredbe (ES) št. 178/2002
(c) The Authority shall make the standard data formats and software packages, as adopted, available on its website.
(c) Agencija da standardne oblike zapisa podatkov in pakete programske opreme, kot so bili sprejeti, na voljo na svojem spletišču.
(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.]