natgillin/translations-raw huggingface dataset:
(35) For the purposes of ensuring transparency of the risk assessment process, it is also necessary to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also cover applications for authorisations in the context of Regulation (EC) No 1831/2003 as regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and Regulation (EC) No 1107/2009 as regards plant protection products.
(35) Za zagotovitev preglednosti postopka ocenjevanja tveganja je prav tako treba razširiti področje uporabe Uredbe (ES) št. 178/2002, ki je trenutno omejeno na živilsko zakonodajo, da se vanj vključijo tudi zahtevki za dovoljenje v okviru Uredbe (ES) št. 1831/2003 v zvezi s krmnimi dodatki, vloge za odobritev v okviru Uredbe (ES) št. 1935/2004 v zvezi z materiali, namenjenimi za stik z živili, in vloge za registracijo v okviru Uredbe (ES) št. 1107/2009 v zvezi s fitofarmacevtskimi sredstvi.
In particular, the Authority should organise the preparatory work supporting the Panels' tasks, including by requesting the Authority's staff or national scientific organisations networking with the Authority to draft preparatory scientific opinions to be peer-reviewed and adopted by the Panels.
Agencija bi zlasti morala organizirati pripravljalno delo v podporo nalogam, ki jih opravljajo znanstveni sveti, tudi tako, da od osebja Agencije ali nacionalnih znanstvenih organizacij, ki se povezujejo z Agencijo, zahteva, da pripravijo osnutek pripravljalnih znanstvenih mnenj, za katere bo opravljen medsebojni strokovni pregled in ki jih bodo sprejeli znanstveni sveti.
Estimated impact on EFSA revenue
Ocenjene posledice za prihodke EFSA
4) develop a more effective and transparent risk communication with the public in collaboration with Member States]
4) razviti učinkovitejše in preglednejše obveščanje javnosti o tveganju v sodelovanju z državami članicami.]
XThe proposal/initiative relates to an action redirected towards a new action
XPredlog/pobuda se nanaša na obstoječ ukrep, preusmerjen v nov ukrep.
The general plan should identify the key factors that need to be taken into account when considering the type and level of communication activities needed, ascertain the tools and channels for the relevant risk communication initiatives taking into account the relevant target audience groups; and, establish appropriate mechanisms to ensure coherent risk communication.
V splošnem načrtu bi bilo treba opredeliti ključne dejavnike, ki jih je treba upoštevati pri določanju vrste in ravni potrebnih dejavnosti obveščanja, opredeliti orodja in kanale za ustrezne pobude obveščanja o tveganju, pri čemer se upoštevajo zadevne ciljne skupine, in vzpostaviti ustrezne mehanizme za zagotovitev usklajenega obveščanja o tveganju.
Stakeholders engagement in RA process 12.5 FTES 0.646 1.131 1.615
Sodelovanje zainteresiranih strani v postopku ocenjevanja tveganja 12,5 EPDČ 0,646 1,131 1,615
Regulation (EC) No 1107/2009 is amended as follows:
Uredba (ES) št. 1107/2009 se spremeni:
Subtotal for specific objective No 2 6.000 10.500 15.000 15.000 15.000 61.500
Seštevek za specifični cilj št. 2 6,000 10,500 15,000 15,000 15,000 61,500
4) Strengthen risk communication between the Commission/EFSA /Members States and public /stakeholders.
4) Predlog bo okrepil obveščanje javnosti/zainteresiranih strani s strani Komisije/agencije EFSA/držav članic.
- during the evaluation phase of a call for proposals/tender, the proposers and tenderers are checked against the published exclusion criteria based on declarations and the Early Detection and Exclusion System (EDES);
- preverjanje predlagateljev in ponudnikov glede na objavljena izločitvena merila na podlagi izjav ter sistema za zgodnje odkrivanje in izključitev med ocenjevalno fazo razpisa za zbiranje predlogov/ponudb;
Accordingly, it is necessary to amend Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009 to provide for additional confidential items to those set out in Regulation (EC) No 178/2002.
Zato je treba spremeniti Direktivo 2001/18/ES, Uredbo (ES) št. 1829/2003, Uredbo (ES) št. 1831/2003, Uredbo (ES) št. 1935/2004 in Uredbo (ES) št. 1107/2009, da se določijo dodatni zaupni elementi poleg tistih, ki so določeni v Uredbi (ES) št. 178/2002.
It is therefore appropriate that the studies planned for supporting requests for renewals should be notified by the applicant to the Authority and that following a consultation of third parties on these planned studies, the Authority systematically provides advice to the applicants on the content of the intended renewal application, taking into account the received comments.
Iz tega razloga je primerno, da vlagatelj načrtovane študije v podporo vlogam za obnovitev odobritve priglasi Agenciji in da Agencija po posvetovanju s tretjimi osebami o teh načrtovanih študijah sistematično svetuje vlagateljem o vsebini predvidene vloge za obnovitev odobritve, ob upoštevanju prejetih pripomb.
[21: Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, (OJ L 31, 1.2.2002, p.
[21: Uredba (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane (UL L 31, 1.2.2002, str.
First, it will establish a Union register of commissioned studies on substances subject to a food law authorisation system, to be managed by EFSA.
S predlogom bo najprej vzpostavljen register Unije naročenih študij o snoveh, vključenih v sistem za odobritev v okviru živilske zakonodaje, ki ga bo upravljala EFSA.
AST Total
AST skupaj
Pre-submission meetings without PC 6.2 FTEs 176 dossiers & meetings 7 days/dossier 0.318 0.557 0.796
Seje pred vložitvijo brez javnega posvetovanja 6,2 EPDČ 176 spisov in sej 7 dni/spis 0,318 0,557 0,796
A Union register of studies commissioned by business operators to obtain an authorisation under Union food law is hereby established.
Vzpostavi se register študij Unije, ki so jih naročili nosilci dejavnosti, da bi pridobili odobritev na podlagi živilske zakonodaje Unije.
General plan for risk communication
Splošni načrt obveščanja o tveganju
New indemnity regime panels experts 2520 panel members days year Tot.
Nova shema zavarovanja odgovornosti za strokovnjake znanstvenih svetov 2520 članov svetov/št.
Stakeholders engagement in RA process 50 events/year 10 panels5event panel/y 0.600 1.050 1.500 1.500 1.500 6.150
Sodelovanje zainteresiranih strani v postopku ocenjevanja tveganja 50 dogodkov/leto 10 svetov, 5 dogodkov/svet/leto 0,600 1,050 1,500 1,500 1,500 6,150
Should that be the case, the Authority shall follow the procedure laid down in Article 39b, which shall apply mutatis mutandis.
V tem primeru ravna agencija v skladu s postopkom iz člena 39b, ki se uporablja smiselno.
4) develop a more effective and transparent risk communication with the public in collaboration with Member States
4) Razviti učinkovitejše in preglednejše obveščanje javnosti o tveganju v sodelovanju z državami članicami
The Authority shall consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the Authority in accordance with Article 38 and Articles 39 to 39f in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation.
Agencija se po objavi študij v podporo vlogam za odobritev v skladu s členom 38 in členi 39 do 39f o njih posvetuje z zainteresiranimi stranmi in javnostjo, da bi ugotovila, ali so na voljo drugi ustrezni znanstveni podatki ali študije o predmetu vloge za odobritev.
(4) In Article 28, the following paragraph 4 is added:
(4) v členu 28 se doda naslednji odstavek 4:
As announced in the Communication replying to the European Citizens' Initiative "Ban glyphosate and protect people and the environment from toxic pesticides", this proposal is a targeted revision of the GFL Regulation (and other measures adopted in that framework) in order to improve transparency in risk assessment, reliability, objectivity and independence of studies used by EFSA in its risk assessment, risk communication, and governance of EFSA.
Kot je Komisija napovedala v svojem sporočilu v odgovor na evropsko državljansko pobudo „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi", gre pri tem predlogu za ciljno revizijo uredbe o splošni živilski zakonodaji (in drugih ukrepov, sprejetih v navedenem okviru), da se izboljšajo preglednost v oceni tveganja, zanesljivost, objektivnost in neodvisnost študij, ki jih EFSA uporabi v svoji oceni tveganja, obveščanje o tveganju in upravljanje agencije EFSA.
- regular training on issues related to fraud and irregularities is given to all staff involved in contract management as well as to auditors and controllers who verify the beneficiaries' declarations on the spot.
- vsi zaposleni, ki so vključeni v upravljanje pogodb, ter revizorji in nadzorniki, ki preverjajo izjave upravičencev na kraju samem, se redno izobražujejo o vprašanjih, povezanih z goljufijami in nepravilnostmi.
Preparatory work sharing with MSs grants/procurements 5.120 8.960 12.800 12.800 12.800 52.480
Pripravljalno delo skupaj z DČ nepovratna sredstva/naročila 5,120 8,960 12,800 12,800 12,800 52,480
improve the governance of and strengthen the scientific cooperation of Member States with and their involvement in the EFSA;
izboljšanja upravljanja agencije EFSA in krepitve znanstvenega sodelovanja držav članic z agencijo ter njihove vključenosti v delovanje agencije;
3) Better Involving Members States in EFSA's governance structure and Scientific Panels and thus support the sustainability in the long-term of EFSA risk assessment without touching on its independence.
3) Predlog bo omogočil boljše vključevanje držav članic v strukturo upravljanja in znanstvene svete agencije EFSA, s čimer bo podpiral dolgoročno trajnost ocenjevanja tveganja agencije EFSA, ne da bi to vplivalo na njeno neodvisnost.
(c) in paragraph 3 the following point (m) is added:
(c) v odstavku 3 se doda naslednja točka (m):
Regulation (EU) 2016/679 of the European Parliament and of the Council and Regulation (EC) No 45/2001 of the European Parliament and of the Council shall apply to the processing of personal data carried out pursuant to this Regulation.
Za obdelavo osebnih podatkov v skladu s to uredbo se uporabljata Uredba (EU) 2016/679 Evropskega parlamenta in Sveta ter Uredba (ES) št. 45/2001 Evropskega parlamenta in Sveta.
"Article 61
„Člen 61
Preparatory work sharing with MSs 6.9 FTEs 0.356 0.624 0.891
Pripravljalno delo skupaj z DČ 6,9 EPDČ 0,356 0,624 0,891
(1) in Article 6, the following paragraph 5 is added:
(1) v členu 6 se doda naslednji odstavek 5:
(i) inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them; and,
(i) o vlogi nemudoma obvesti druge države članice in Komisijo ter jim da na voljo vlogo z vsemi morebitnimi dodatnimi informacijami, ki jih je predložil vlagatelj; ter
Current 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.
Sedanji postopki temeljijo na načelu, da mora vlagatelj dokazati, da na podlagi znanstvenih dognanj, ki so mu na voljo, predmet odobritvenega postopka izpolnjuje varnostne zahteve Unije.
day cost= 2549 1.408 2.464 3.520 3.520 3.520 14.432
dni/leto Skupni dnevni stroški = 2549 1,408 2,464 3,520 3,520 3,520 14,432
Review of confidentiality
Pregled zaupnosti
Regulation (EC) No 2065/2003 is amended as follows:
Uredba (ES) št. 2065/2003 se spremeni:
In its Communication replying to the European Citizens' Initiative "Ban glyphosate and protect people and the environment from toxic pesticides", the Commission also announced the preparation of a legislative proposal "covering transparency in scientific assessments, quality and independence of the scientific studies that are the basis of the Union risk assessment carried out by EFSA and the governance of EFSA".
Komisija je v svojem sporočilu v odgovor na evropsko državljansko pobudo „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi" napovedala tudi pripravo zakonodajnega predloga, ki zajema preglednost znanstvenih ocen, kakovost in neodvisnost znanstvenih študij, na katerih temelji ocena tveganja v Uniji, ki jo izvede EFSA, ter upravljanje agencije EFSA.
(d) The nominations by the Member States, the selection by the Executive Director and the appointments by the Management Board shall be made on the basis of the following criteria:
(d) Na podlagi naslednjih meril države članice predlagajo strokovnjake, izvršni direktor jih izbere in upravni odbor imenuje:
It is therefore necessary to ensure a more comprehensive and continuous risk communication process throughout the risk analysis process, involving Union and national risk assessors and risk managers combined with open dialogue amongst all interested parties.
Zato je treba zagotoviti bolj celovit in stalen postopek obveščanja o tveganju med celotnim postopkom analize tveganja, ki vključuje odgovorne za oceno tveganja in odgovorne za obvladovanje tveganja na ravni Unije in nacionalni ravni, skupaj z odprtim dialogom med vsemi zainteresiranimi stranmi.
Article 8
Člen 8
3) improve the governance, strengthen the involvement of Member States and address the limitations affecting the long term scientific capacity of EFSA
3) Izboljšati upravljanje, okrepiti vključenost držav članic ter odpraviti omejitve, ki vplivajo na dolgoročno znanstveno zmogljivost agencije EFSA
Direct management by the Commission through
Neposredno upravljanje - Komisija:
The Commission acknowledged in its Communication in reply to the European Citizen's Initiative (ECI) "Ban glyphosate and protect people and environment from toxic pesticides" that "transparency in scientific assessments and decision-making is vital to ensuring consumers' confidence in the regulatory system.
Komisija je v svojem sporočilu v odgovor na evropsko državljansko pobudo „Prepovejmo glifosat ter obvarujmo ljudi in okolje pred strupenimi pesticidi" potrdila, da je „preglednost znanstvenih ocen in postopka odločanja bistvena za zaupanje v regulativni okvir".
(i) inform the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them; and,
(i) o vlogi obvesti druge države članice in Komisijo ter jim da na voljo vlogo z vsemi dodatnimi informacijami, ki jih je predložil vlagatelj; ter
Subtotal for specific objective No 3 9.592 16.785 23.979 23.979 23.979 98.314
Seštevek za specifični cilj št. 3 9,592 16,785 23,979 23,979 23,979 98,314
Function group IV
Funkcionalna skupina IV
XX 01 02 02 (AC, AL, END, INT and JED in the Delegations)
XX 01 02 02 (PU, LU, NNS, ZU in MSD na delegacijah)
(4) It is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers.
(4) Zato je treba zagotoviti celovit in stalen postopek obveščanja o tveganju med celotnim postopkom analize tveganja, ki vključuje odgovorne za oceno tveganja in odgovorne za obvladovanje tveganja na ravni Unije in nacionalni ravni.
Directive (EC) No 2001/18/EC is amended as follows:
Direktiva 2001/18/ES se spremeni:
(10) the following Article 57a is inserted after the title of Section 1 in Chapter V:
(10) v poglavju V se pod naslov oddelka 1 vstavi naslednji člen 57a:
Regulation (EC) No 1935/2004 is amended as follows:
Uredba (ES) št. 1935/2004 se spremeni:
Article 8c
Člen 8c
The Authority shall ensure public access to the additional information supplied by the applicant in accordance with Articles 11 and 12.
Agencija v skladu s členoma 11 in 12 zagotovi javni dostop do dodatnih informacij, ki jih je predložil predlagatelj.
Pre-submission meetings for all renewals with PC 4.3 FTEs 74applications 7 man-days+ 4 PC 0.220 0.385 0.550
Seje pred vložitvijo za vse obnovitve z javnim posvetovanjem 4,3 EPDČ 74 vlog 7 delovnih dni + 4 javna posvetovanja 0,220 0,385 0,550
New indemnity regime working groups Tot.
Nova shema zavarovanja odgovornosti za delovne skupine Skupno število strokovnjakov/št.
(2) in Article 15, at the end of paragraph 1 the following sentence is added:
(2) v členu 15 se na koncu odstavka 1 doda naslednji stavek:
Regulation (EC) No 1331/2008 is amended as follows:
Uredba (ES) št. 1331/2008 se spremeni:
Article 8a
Člen 8a
"(c) ensure public access to the application and any information supplied by the applicant, in accordance with Article 18.
„(c) v skladu s členom 18 zagotoviti javni dostop do zahtevka in vseh informacij, ki jih je predložil vložnik.
In accordance with the conditions and the procedures laid down in Articles 39 to 39f of Regulation (EC) No 178/2002 and this Article, the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification; and, the Authority shall assess the confidentiality request submitted by the applicant.
V skladu s pogoji in postopki iz členov 39 do 39f Uredbe (ES) št. 178/2002 in tega člena lahko vložnik zahteva, da se nekatere informacije, predložene na podlagi te uredbe, obravnavajo zaupno, pri čemer priloži preverljivo utemeljitev; ter urad oceni zahtevo za zaupnost, ki jo je predložil vložnik.
Objectives of risk communication
Cilji obveščanja o tveganju
(a) the notifier/applicant may request certain information submitted under this Directive to be kept confidential, accompanied by verifiable justification; and,
(a) lahko prijavitelj/vlagatelj zahteva, da se nekatere informacije, predložene na podlagi te direktive, obravnavajo zaupno, pri čemer priloži preverljivo utemeljitev; ter
Function group II
Funkcionalna skupina II
In accordance with the conditions and the procedures laid down in Article 39 of Regulation (EC) No 178/2002 and this article, the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification.
V skladu s pogoji in postopki iz člena 39 Uredbe (ES) št. 178/2002 in tega člena lahko vlagatelj zahteva, da se nekatere informacije, predložene na podlagi te uredbe, obravnavajo zaupno, pri čemer priloži preverljivo utemeljitev.
AD Total
AD skupaj
2023 2024 esq. (see point 1.6)
2023 2024- (gl. točko 1.6)
"Article 25
„Člen 25
[Heading………………………………] Diff./non-diff. from EFTA countries from candidate countries from third countries within the meaning of Article 21(2)(b) of the Financial Regulation
držav Efte držav kandidatk tretjih držav po členu 21(2)(b) finančne uredbe
General principles of risk communication
Splošna načela obveščanja o tveganju
"Article 32a
„Člen 32a
Specific objective No
Specifični cilji
It aligns the composition of EFSA's Management Board with the Common Approach on decentralized agencies by including representatives of all Member States.
Sestavo upravnega odbora agencije EFSA usklajuje s skupnim pristopom k decentraliziranim agencijam, in sicer z vključitvijo predstavnikov vseh držav članic.
General advice
Splošno mnenje
day cost= 2549 2.571 4.492 6.426 6.426 6.426 26.347
delovnih dni = 4600 Skupni dnevni stroški = 2549 2,571 4,492 6,426 6,426 6,426 26,347
MB with MSs & observers 0.2 FTEs 0.010 0.018 0.025
Upravni odbor z DČ in opazovalci 0,2 EPDČ 0,010 0,018 0,025
(b) the following paragraph 1a is inserted:
(b) vstavi se naslednji odstavek 1a:
PC on all dossiers 8.5 FTEs 376dossiers for PC 0.5 effort/day+4 outcome 0.437 0.765 1.093
javno posvetovanje o vseh spisih 8,5 EPDČ 376 spisov za javno posvetovanje 0,5 dneva (javno posvetovanje) + 4 dni za rezultat 0,437 0,765 1,093
Function group I
Funkcionalna skupina I
(9) in Article 41, the following sentence is added at the end of paragraph 1:
(9) v členu 41 se na koncu odstavka 1 doda naslednji stavek:
"Article 30
„Člen 30
[40: Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p.
[40: Uredba (ES) št. 1367/2006 Evropskega parlamenta in Sveta z dne 6. septembra 2006 o uporabi določb Aarhuške konvencije o dostopu do informacij, udeležbi javnosti pri odločanju in dostopu do pravnega varstva v okoljskih zadevah v institucijah in organih Skupnosti (UL L 264, 25.9.2006, str.
[22: Commission Staff Working Document, "The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002)", SWD(2018)38 final, dated 15.1.2018.]
[22: Delovni dokument služb Komisije „The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002)" („Ocena splošne živilske zakonodaje (Uredbe (ES) št. 178/2002) v okviru programa REFIT"), SWD(2018) 38 final, z dne 15. januarja 2018.]
"Article 39a
„Člen 39a
(5) in Article 63, paragraphs 1 and 2 are replaced by the following:
(5) v členu 63 se odstavka 1 in 2 nadomestita z naslednjim:
Estimated impact on [body]'s appropriations
Ocenjene posledice za odobritve [organa]
[3: Commission Staff Working Document, "The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002)", SWD (2018)38 final, dated 15.1.2018.]
[3: Delovni dokument služb Komisije, The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002) („Ocena splošne živilske zakonodaje (Uredbe (ES) št. 178/2002) v okviru programa REFIT"), SWD(2018) 38 final, z dne 15. januarja 2018.]
Article 5
Člen 5
Estimated impact on [body]'s human resources
Ocenjene posledice za človeške vire [organa]
2) increase the guarantees of reliability, objectivity and independence of studies used by EFSA in its risk assessment, in particular in the framework of authorisation applications;
2) povečati jamstva glede zanesljivosti, objektivnosti in neodvisnosti študij, ki jih EFSA uporabi v svojih ocenah tveganja, zlasti v okviru vlog za odobritev;
It is also essential to this end that the Executive Director whose function is to defend EFSA's interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts.
Zato je prav tako nujno, da je v izbor in imenovanje navedenih znanstvenih strokovnjakov vključen tudi izvršni direktor, katerega naloga je ščititi interese Agencije in zlasti neodvisnost njenega strokovnega znanja.
It aligns the composition of EFSA's Management Board with the Common Approach on Union decentralised agencies by including representatives of all Member States.
Sestavo upravnega odbora agencije EFSA usklajuje s skupnim pristopom k decentraliziranim agencijam Unije, in sicer z vključitvijo predstavnikov vseh držav članic.
(2) In Article 13, the following paragraph 2a is inserted:
(2) v člen 13 se vstavi naslednji odstavek 2a:
(9) in Article 29, paragraphs 1 and 2 are replaced by the following:
(9) v členu 29 se odstavka 1 in 2 nadomestita z naslednjim:
"The Authority shall ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant in accordance with Article 23.
„Agencija v skladu s členom 23 zagotovi javni dostop do vloge, zadevnih podpornih informacij in vseh dodatnih informacij, ki jih je predložil vložnik.
In the case of renewals, the pre-submission procedure foresees that studies planned by a potential applicant will have to be notified to EFSA and, after consultation of third parties on these planned studies, the Authority will systematically provide advice to the applicants.
V primeru obnovitev postopek pred vložitvijo vloge določa, da je študije, ki jih načrtuje morebitni vlagatelj, treba priglasiti agenciji EFSA, po posvetovanju s tretjimi osebami o teh načrtovanih študijah pa EFSA sistematično svetuje vlagateljem.