FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: Following this notification, the Authority shall launch a consultation of stakeholders and the public on the intended studies for renewal and shall provide advice on the content of the intended renewal application taking into account the received comments.
Croatian: Nakon te obavijesti, Agencija pokreće savjetovanje s dionicima i javnošću o planiranim studijama u svrhu produženja i pruža podatke o sadržaju planiranog zahtjeva za produženje uzimajući u obzir sve zaprimljene komentare.
English: The measures establishing a register of commissioned studies and the measure providing for a consultation on submitted studies will bring benefits by ensuring that EFSA has access to as much evidence as possible on a substance submitted for its assessment.
Croatian: Mjere u okviru kojih se uspostavlja registar naručenih studija i mjera u okviru koje se održava savjetovanje o podnesenim studijima donijet će koristi osiguranjem EFSA-ina pristupa najvećoj mogućoj količini dokaza o tvarima podnesenima radi procjene.
English: Directive (EC) No 2001/18/EC is amended as follows:
Croatian: Direktiva (EZ) 2001/18/EZ mijenja se kako slijedi:
English: On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether an authorisation for a product referred to in Article 3(1) still meets the conditions set by this Regulation.
Croatian: „1. Agencija na vlastitu inicijativu ili na zahtjev države članice ili Komisije izdaje mišljenje o tome zadovoljava li još uvijek odobrenje za proizvod iz članka 3. stavka 1. uvjete utvrđene ovom Uredbom.
English: PC on all dossiers 8.5 FTEs 376dossiers for PC 0.5 effort/day+4 outcome 0.437 0.765 1.093
Croatian: Javno savjetovanje o svim dosjeima 8,5 EPRV-a 376 dosjea za javno savjetovanje 0,5 radnih dana + 4 rezultata 0,437 0,765 1,093
English: (1) in Chapter II the following SECTION 1a is inserted:
Croatian: (1) U poglavlju II. umeće se sljedeći ODJELJAK 1.a:
English: (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,
Croatian: i. bez odgode obavijestit ostale države članice i Komisiju o zahtjevu te i njima na raspolaganje staviti taj zahtjev i sve dopunske informacije koje je dostavio podnositelj zahtjeva; i
English: Pre-submission meetings for all renewals with PC 4.3 FTEs 74applications 7 man-days+ 4 PC 0.220 0.385 0.550
Croatian: Sastanci prije podnošenja zahtjeva za sva produljenja s javnim savjetovanjem 4,3 EPRV-a 74 zahtjeva 7 dana rada+ 4 javna savjetovanja 0,220 0,385 0,550
English: Function group IV
Croatian: Funkcijska skupina IV.
English: 4) develop a more effective and transparent risk communication with the public in collaboration with Member States
Croatian: 4. razviti djelotvornije i transparentnije obavješćivanje javnosti o riziku u suradnji s državama članicama
English: Toxicological studies (H2020-FP9) 2FTEs 0.103 0.181 0.258
Croatian: Toksikološke studije (H2020-FP9) 2 EPRV-a 0,103 0,181 0,258
English: "Article 32a
Croatian: „Članak 32.a
English: (2) in Article 15, at the end of paragraph 1 the following sentence is added:
Croatian: (2) u članku 15. na kraju stavka 1. dodaje se sljedeća rečenica:
English: Review of confidentiality
Croatian: Preispitivanje povjerljivosti
English: Regulation (EC) No 2065/2003 is amended as follows:
Croatian: Uredba (EZ) br. 2065/2003 mijenja se kako slijedi:
English: 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".
Croatian: U svojoj Komunikaciji o europskoj građanskoj inicijativi „Zabrana glifosata i zaštita ljudi i okoliša od toksičnih pesticida" Komisija je najavila i pripremu zakonodavnog prijedloga „kojim će se obuhvatiti transparentnost znanstvenih procjena, kvaliteta i neovisnost znanstvenih studija na kojima se temelji EU-ova procjena rizika koju provodi EFSA te upravljanje EFSA-om".
English: 3) improve the governance, strengthen the involvement of Member States and address the limitations affecting the long term scientific capacity of EFSA
Croatian: 3. poboljšati upravljanje, povećati uključenost država članica i suočiti se s ograničenjima koja utječu na dugoročni znanstveni kapacitet EFSA-e
English: The notified information shall be made public only in case a corresponding application for authorisation has been received and after the Authority has decided on the disclosure of the accompanying studies in accordance with Article 38 and Articles 39 to 39f.
Croatian: Dostavljene informacije objavljuju se samo ako je zaprimljen odgovarajući zahtjev za odobrenje te nakon što Agencija odluči o objavljivanju popratnih studija u skladu s člankom 38. i člancima od 39. do 39.f.
English: Regulation (EC) No 1935/2004 is amended as follows:
Croatian: Uredba (EZ) br. 1935/2004 mijenja se kako slijedi:
English: (16) Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession.
Croatian: (16) Postupci odobravanja temelje se na načelu da je podnositelj zahtjeva dužan dokazati da je, prema znanstvenim podacima kojima raspolaže, predmet postupka odobravanja u skladu sa sigurnosnim zahtjevima Unije.
English: (b) the Authority shall assess the confidentiality request submitted by the applicant.
Croatian: (b) Agencija ocjenjuje zahtjev za povjerljivost koji je podnio podnositelj zahtjeva.
English: 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.
Croatian: Agencija bi posebno trebala organizirati pripremni rad kao podršku panelima, među ostalim tako što će od svojeg osoblja ili od nacionalnih znanstvenih organizacija umreženih s Agencijom tražiti izradu nacrtâ znanstvenih mišljenja koja su u pripremi, a koja potom prolaze stručno ocjenjivanje prije nego što ih paneli donesu.
English: The general plan for risk communication shall promote an integrated risk communication framework to be followed both by the risk assessors and the risk managers in a coherent and systematic manner both at Union and national level.
Croatian: Opći plan obavješćivanja o rizicima promiče integrirani okvir obavješćivanja o rizicima kojega su se na usklađen i sustavan način dužne pridržavati i osobe koje procjenjuju rizik i osobe koje upravljaju rizikom i na razini Unije i na nacionalnoj razini.
English: 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.
Croatian: Drugom se mjerom utvrđuje postupak prije podnošenja zahtjeva u okviru kojeg EFSA može podnositelju zahtjeva dati svoje mišljenje (bez primjedbi o planu studije), a to će se mišljenje javno objaviti.
English: "Article 25
Croatian: "Članak 25.
English: Subtotal for specific objective No 3 9.592 16.785 23.979 23.979 23.979 98.314
Croatian: Međuzbroj za posebni cilj br. 3. 9,592 16,785 23,979 23,979 23,979 98,314
English: "Article 39
Croatian: „Članak 39.
English: 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.
Croatian: U skladu s uvjetima i postupcima iz članaka 39. do 39.f Uredbe (EZ) br. 178/2002 i ovog članka, podnositelj zahtjeva može zahtijevati da određene informacije podnesene na temelju ove Uredbe ostanu povjerljive, popraćeno provjerljivim obrazloženjem; te Agencija ocjenjuje zahtjev za povjerljivost koji je podnio podnositelj zahtjeva.
English: Preparatory work sharing with MSs 6.9 FTEs 0.356 0.624 0.891
Croatian: Pripremni rad u suradnji s državama članicama 6,9 EPRV-a 0,356 0,624 0,891
English: NO YES/NO
Croatian: NE DA/NE
English: (b) the competent authority shall assess the confidentiality request submitted by the notifier/applicant.
Croatian: (b) nadležno tijelo ocjenjuje zahtjev za povjerljivost koji je podnio podnositelj obavijesti/podnositelj zahtjeva.
English: It aligns the composition of EFSA's Management Board with the Common Approach on decentralized agencies by including representatives of all Member States.
Croatian: Usklađuje se sastav Upravnog vijeća EFSA-e sa zajedničkim pristupom o decentraliziranim agencijama uključivanjem predstavnika svih država članica.
English: (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.
Croatian: (4) Stoga je potrebno osigurati sveobuhvatan i stalan proces obavješćivanja o rizicima tijekom cijele analize rizika u koji su uključene osobe koje procjenjuju rizik i osobe koje upravljaju rizikom na razini Unije i nacionalnoj razini.
English: The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 of this Regulation shall start either on the Commission's initiative or following an application to the Commission by an applicant, in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002.
Croatian: „1. Postupak odobravanja stavljanja nove hrane na tržište unutar Unije i ažuriranja popisa Unije, kako je predviđeno u članku 9. ove Uredbe, započinje ili na inicijativu Komisije ili na zahtjev podnositelja zahtjeva Komisiji, u skladu sa standardnim formatima podataka, ako postoje u skladu s člankom 39.f Uredbe (EZ) br. 178/2002. Komisija taj zahtjev bez odgode stavlja na raspolaganje državama članicama.";
English: "Article 30
Croatian: „Članak 30.
English: Decision on confidentiality
Croatian: Odluka o povjerljivosti
English: "(c) ensure public access to the application and any information supplied by the applicant, in accordance with Article 18.
Croatian: „(c) osigurati javni pristup zahtjevu i svim informacijama koje je dostavio podnositelj zahtjeva, u skladu s člankom 18.";
English: Expected result(s) and impact
Croatian: Očekivani rezultati i utjecaj
English: Article 8c
Croatian: Članak 8.c
English: The applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification, upon submission of the application.
Croatian: Podnositelj zahtjeva može zahtijevati da određene informacije podnesene na temelju ove Uredbe ostanu povjerljive, popraćeno provjerljivim obrazloženjem, nakon podnošenja zahtjeva.
English: The advice provided by the staff of the Authority shall be without prejudice and non-committal as to the subsequent assessment of applications for authorisation by the Scientific Panels.
Croatian: Savjeti koje daje osoblje Agencije nisu obvezujući i ne dovode u pitanje potonju procjenu zahtjeva za odobrenje od strane znanstvenih panela.
English: 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.
Croatian: U svojoj Komunikaciji o europskoj građanskoj inicijativi „Zabrana glifosata i zaštita ljudi i okoliša od toksičnih pesticida" Komisija se složila „da je transparentnost znanstvenih procjena i donošenja odluka ključna za povjerenje u regulatorni sustav.
English: Regulation (EC) No 1331/2008 is amended as follows:
Croatian: Uredba (EZ) br. 1331/2008 mijenja se kako slijedi:
English: Transitional measures
Croatian: Prijelazne mjere
English: "Article 15
Croatian: „Članak 15.
English: XX 01 02 02 (AC, AL, END, INT and JED in the Delegations)
Croatian: XX 01 02 02 (UO, LO, UNS, UsO i MSD u delegacijama)
English: (9) in Article 29, paragraphs 1 and 2 are replaced by the following:
Croatian: (9) u članku 29. stavci 1. i 2. zamjenjuju se sljedećim:
English: "Article 23
Croatian: „Članak 23.
English: Objectives of risk communication
Croatian: Ciljevi obavješćivanja o riziku
English: Strengthen advocacy: targeted messages, narrative, translations, etc Increase targeted communication key topics Sc.literacy actions 1.700 2.975 4.250 4.250 4.250 17.425
Croatian: Povećanje ciljanog obavješćivanja o ključnim temama Aktivnosti za znan. pismenost 1,700 2,975 4,250 4,250 4,250 17,425
English: The proposal/initiative does not require the use of appropriations of an administrative nature
Croatian: Za prijedlog/inicijativu nisu potrebna odobrena administrativna sredstva
English: Article 8b
Croatian: Članak 8.b
English: There should be no negative impact for innovation from the measures on the reliability and robustness of studies.
Croatian: Mjere za pouzdanost i činjeničnost studija ne bi trebale negativno utjecati na inovacije.
English: "(l) an identification of the parts of the application and any other supplementary information that the applicant requests to be kept confidential, accompanied by verifiable justification, pursuant to Articles 30 of this Regulation and Article 39 of Regulation (EC) No 178/2002; ";
Croatian: „(l) identifikacija dijelova zahtjeva i svih ostalih dopunskih informacija za koje je podnositelj zahtjeva zatražio da ostanu povjerljive, popraćeno provjerljivim obrazloženjem, u skladu s člankom 30. ove Uredbe i člankom 39. Uredbe (EZ) br. 178/2002; ";
English: (a) the notifier/applicant may request certain information submitted under this Directive to be kept confidential, accompanied by verifiable justification; and,
Croatian: (a) podnositelj obavijesti/podnositelj zahtjeva može zahtijevati da određene informacije predane na temelju ove Direktive ostanu povjerljive, popraćeno provjerljivim obrazloženjem; i
English: Public access to all scientific data and information supporting requests for authorisations under Union food law as well as other requests for scientific output should be ensured, as early as possible in the risk assessment process.
Croatian: Pristup javnosti (i to što ranije u fazi procesa procjene rizika) svim znanstvenim podacima i informacijama kojima se potkrepljuju zahtjevi za odobrenje na temelju propisa Unije o hrani, kao i drugim zahtjevima za pružanje znanstvenih rezultata, trebao bi biti zajamčen.
English: "(l) an identification of the parts of the application and any other supplementary information that the applicant requests to be kept confidential, accompanied by verifiable justification, pursuant to Articles 30 of this Regulation and Articles 39 to 39f of Regulation (EC) No 178/2002; ",
Croatian: „(l) identifikacija dijelova zahtjeva i svih ostalih dopunskih informacija za koje je podnositelj zahtjeva zatražio da ostanu povjerljive, popraćeno provjerljivim obrazloženjem, u skladu s člankom 30. ove Uredbe i člancima 39. do 39.f Uredbe (EZ) br. 178/2002; ",
English: 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.
Croatian: Stoga se mora uspostaviti sveobuhvatan i neprekidan postupak obavješćivanja o riziku tijekom cijelog procesa analize rizika, pri čemu u njemu trebaju sudjelovati EU-ovi i nacionalni procjenitelji rizika i upravitelji rizikom te treba voditi otvoreni dijalog sa svim zainteresiranim stranama.
English: [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.]
Croatian: [3: Radni dokument službi Komisije, „Evaluacija općih propisa o hrani (Uredba (EZ) br. 178/2002) u okviru programa REFIT", SWD(2018) 38 final, 15. siječnja 2018.]
English: It aligns the composition of EFSA's Management Board with the Common Approach on Union decentralised agencies by including representatives of all Member States.
Croatian: Usklađuje se sastav Upravnog vijeća EFSA-e sa zajedničkim pristupom o decentraliziranim agencijama Unije uključivanjem predstavnika svih država članica.
English: [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.]
Croatian: [22: Radni dokument službi Komisije „Evaluacija općih propisa o hrani (Uredba (EZ) 178/2002) u okviru programa REFIT", SWD(2018)38 final, od 15. siječnja 2018.]
English: (9) in Article 41, the following sentence is added at the end of paragraph 1:
Croatian: (9) u članku 41. na kraju stavka 1. dodaje se sljedeća rečenica:
English: The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of the applications for renewal of authorisation by the Scientific Panels.
Croatian: Savjeti koje daje Agencija nisu obvezujući i njima se ne dovodi u pitanje potonja procjena zahtjeva za produljenje odobrenja od strane znanstvenih panela.
English: (4) In Article 28, the following paragraph 4 is added:
Croatian: (4) U članku 28. dodaje se sljedeći stavak 4.:
English: 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.
Croatian: Agencija ne objavljuje informacije za koje je zatraženo povjerljivo postupanje pod uvjetima utvrđenima ovim člankom.
English: The applicant shall clearly indicate the grounds on the basis of which confidentiality is requested for the different pieces of information.
Croatian: Za svaku od tih informacija podnositelj zahtjeva mora jasno navesti razloge na temelju kojih traži povjerljivo postupanje.
English: Review clause
Croatian: Klauzula o preispitivanju
English: 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.
Croatian: Osim toga, skupe studije kojima se u konačnici pomaže industriji da neki proizvod stavi na tržište ne bi trebalo plaćati javnim sredstvima.
English: (a) the applicant may request certain information submitted under this Regulation to be kept confidential, accompanied by verifiable justification; and,
Croatian: (a) podnositelj zahtjeva može zahtijevati da određene informacije podnesene na temelju ove Uredbe ostanu povjerljive, popraćeno provjerljivim obrazloženjem; i
English: 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;
Croatian: 2. zajamčiti veću pouzdanost, objektivnost i neovisnost studija koje EFSA upotrebljava u svojoj procjeni rizika, osobito u kontekstu zahtjeva za odobrenje;
English: "(c) The Authority shall:
Croatian: „(c) Agencija mora:
English: The proposal/initiative does not require the use of operational appropriations
Croatian: Za prijedlog/inicijativu nisu potrebna odobrena sredstva za poslovanje
English: TOTAL 5.490 9.608 13.726 13.726 13.726 56.276
Croatian: UKUPNO 5,490 9,608 13,726 13,726 13,726 56,276
English: Articles 39 to 39f of Regulation (EC) No 178/2002 shall apply mutatis mutandis.
Croatian: Članci 39. do 39.f Uredbe (EZ) br. 178/2002 primjenjuje se mutatis mutandis.";
English: If an applicant in the context of an authorisation procedure withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information as accepted by the Authority in accordance with Articles 39to 39f.
Croatian: Ako podnositelj zahtjeva u kontekstu postupka dobivanja odobrenja povuče ili je povukao zahtjev, Agencija, Komisija i države članice poštuju povjerljivost poslovnih i industrijskih informacija kako ju je prihvatila Agencija u skladu s člancima od 39. do 39.f. Zahtjev se smatra povučenim od trenutka kada nadležno tijelo koje je zaprimilo prvotni zahtjev zaprimi zahtjev za povlačenje u pisanom obliku.
English: 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.
Croatian: Rizik od udvostručivanja posla s obzirom na EFSA-inu stvarnu ovlast da naručuje znanstvene studije potrebne za provedbu njezine misije (članak 32.
English: The Authority shall ensure public access to the additional information supplied by the applicant in accordance with Articles 11 and 12.
Croatian: „5. Agencija osigurava javni pristup dodatnim informacijama koje je dostavio podnositelj zahtjeva u skladu s člancima 11. i 12.";
English: "Article 12
Croatian: „Članak 12.
English: Appeals 8.4 FTEs 450/ dossier10% =45 appeals 10% confid.
Croatian: Žalbe 8,4 EPRV-a 450/ dosje 10 % = 45 žalbi 10 % povjerljivih zahtjeva/dosjei 0,432 0,757 1,081
English: 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.
Croatian: Stoga je primjereno da podnositelj zahtjeva Agenciju obavijesti o planiranim studijama kojima će potkrijepiti zahtjev za obnovu te da nakon konzultacija s trećim stranama o tim planiranim studijama Agencija podnositeljima zahtjeva sustavno daje savjete o sadržaju planiranog zahtjeva za obnovu, uzimajući u obzir primjedbe koje je dobila.
English: TOTAL
Croatian: Ukupno
English: Article 39e
Croatian: Članak 39.e
English: It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1) of this Regulation.
Croatian: Uredbe (EZ) br. 178/2002. Objavljuje i svaki zahtjev za njezino mišljenje, kao i svako produljenje roka u skladu s člankom 6. stavkom 1. ove Uredbe.";
English: "The Authority shall publish all scientific outputs including the scientific opinions issued by it and supporting scientific data and other information in accordance with Article 38 and Articles 39 a to 39f.
Croatian: „Agencija objavljuje sve znanstvene rezultate uključujući znanstvena mišljenja koja donosi i znanstvene podatke kojima su potkrijepljena i druge informacije u skladu s člankom 38. i člancima od 39.a do 39.f.";
English: "The Authority shall publish detailed guidance, following the agreement with the Commission, concerning the preparation and the submission of the application, referred to in paragraph (1), taking into account standard data formats, where they exist in accordance with Article 39f of Regulation (EC) No 178/2002.
Croatian: „Agencija objavljuje detaljne smjernice, na temelju dogovora s Komisijom, povezano s pripremom i podnošenjem zahtjeva, iz stavka 1., uzimajući u obzir standardne formate podataka, ako postoje u skladu s člankom 39.f Uredbe (EZ) br. 178/2002.";
English: increase the guarantees of reliability, objectivity and independence of studies the EFSA uses in its risk assessment, in particular in the context of authorisation applications;
Croatian: zajamči veća pouzdanost, objektivnost i neovisnost studija koje EFSA upotrebljava u svojoj procjeni rizika, osobito u kontekstu zahtjeva za odobrenje,
English: "Article 18
Croatian: „Članak 18.
English: [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.
Croatian: [40: Uredba (EZ) br. 1367/2006 Europskog parlamenta i Vijeća od 6. rujna 2006. o primjeni odredaba Aarhuške konvencije o pristupu informacijama, sudjelovanju javnosti u odlučivanju i pristupu pravosuđu u pitanjima okoliša na institucije i tijela Zajednice (SL L 264, 25.9.2006., str. 13.).]
English: "Article 10
Croatian: „Članak 10.
English: "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.
Croatian: „Agencija osigurava javni pristup zahtjevu, relevantnim popratnim informacijama i svim dopunskim informacijama koje je dostavio podnositelj zahtjeva u skladu s člankom 23.";
English: Article 32e
Croatian: Članak 32.e
English: Article 8
Croatian: Članak 8.
English: (c) in paragraph 3 the following point (m) is added:
Croatian: (c) stavku 3. dodaje se sljedeća točka (m):
English: [36: 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.13).]
Croatian: [36: Uredba (EZ) br. 1367/2006 Europskog parlamenta i Vijeća od 6. rujna 2006. o primjeni odredaba Aarhuške konvencije o pristupu informacijama, sudjelovanju javnosti u odlučivanju i pristupu pravosuđu u pitanjima okoliša na institucije i tijela Zajednice (SL L 264, 25.9.2006., str. 13.).]
English: "Article 20
Croatian: „Članak 20.
English: risk communication
Croatian: Obavješćivanje o riziku
English: It shall:
Croatian: Njime se:
English: Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Commission shall assess the Authority's performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines.
Croatian: Komisija ocjenjuje učinak Agencije s obzirom na njezine ciljeve, mandat, zadaće, postupke i lokaciju u skladu sa smjernicama Komisije, najkasnije pet godina od datuma iz članka [stupanje na snagu Uredbe o izmjeni općih propisa o hrani] te svakih pet godina nakon toga.
English: Function group III
Croatian: Funkcijska skupina III.
English: (a) in paragraph 3 the introductory sentence is replaced by the following:
Croatian: (a) u stavku 3. uvodna rečenica zamjenjuje se sljedećim:
English: Payments (2) 5.490 9.608 13.726 13.726 13.726 56.276
Croatian: Plaćanja (2) 5,490 9,608 13,726 13,726 13,726 56,276
English: (5) in Article 63, paragraphs 1 and 2 are replaced by the following:
Croatian: (5) u članku 63. stavci 1. i 2. zamjenjuju se sljedećim:
English: The Authority shall issue and publish detailed guidelines, following agreement with the Commission, concerning the preparation and the submission of the application, taking into account standard data formats, where they exist in accordance with Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.
Croatian: „2. Agencija izdaje i objavljuje detaljne smjernice, nakon sporazuma s Komisijom, u vezi s pripremom i podnošenjem zahtjeva, uzimajući u obzir standardne formate podataka, ako postoje u skladu s člankom 39.f Uredbe (EZ) br. 178/2002, koja se primjenjuje mutatis mutandis.";
English: (34) In order to ensure consistency with the proposed adaptations in Regulation (EC) No 178/2002, provisions relating to public access and the protection of confidential information in Directive 2001/18/EC of the European Parliament and of the Council, Regulation (EC) No 1829/2003 of the European Parliament and of the Council, in Regulation (EC) No 1831/2003 of the European Parliament and of the Council, in Regulation (EC) No 2065/2003 of the European Parliament and of the Council, in Regulation (EC) No 1935/2004 of the European Parliament and of the Council, in Regulation (EC) No 1331/2008 of the European Parliament and of the Council, in Regulation (EC) No 1107/2009 of the European Parliament and of the Council and in Regulation (EU) 2015/2283 of the European Parliament and of the Council should be amended.
Croatian: (34) Kako bi se zajamčila usklađenost s predloženim prilagodbama Uredbe (EZ) br. 178/2002, trebalo bi izmijeniti odredbe koje se odnose na pristup javnosti i zaštitu povjerljivih informacija u Direktivi 2001/18/EZ Europskog parlamenta i Vijeća, Uredbi (EZ) br. 1829/2003 Europskog parlamenta i Vijeća, Uredbi (EZ) br. 1831/2003 Europskog parlamenta i Vijeća, Uredbi (EZ) br. 2065/2003 Europskog parlamenta i Vijeća, Uredbi (EZ) br. 1935/2004 Europskog parlamenta i Vijeća, Uredbi (EZ) br. 1331/2008 Europskog parlamenta i Vijeća, Uredbi (EZ) br. 1107/2009 Europskog parlamenta i Vijeća te u Uredbi (EU) 2015/2283 Europskog parlamenta i Vijeća.
English: Title 1: Staff expenditure Commitments (1) 5.490 9.608 13.726 13.726 13.726 56.276
Croatian: Glava 1.: Rashodi za osoblje Preuzete obveze (1) 5,490 9,608 13,726 13,726 13,726 56,276
English: (b) the following sentence is added at the end of the second paragraph:
Croatian: (b) na kraju drugog stavka dodaje se sljedeća rečenica:
English: Article 9
Croatian: Članak 9.
English: 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.
Croatian: U slučaju produljenja, u okviru postupka prije podnošenja zahtjeva predviđeno je da potencijalni podnositelj zahtjeva obavijesti EFSA-u o planiranim studijama i da nakon savjetovanja s trećim osobama o tim planiranim studijama Agencija sustavno pruža mišljenja podnositeljima zahtjeva.
English: Article 39d
Croatian: Članak 39.d
English: "Article 16
Croatian: „Članak 16.
English: Article 39f
Croatian: Članak 39.f
English: MB with MSs & observers 0.2 FTEs 0.010 0.018 0.025
Croatian: Upravno vijeće s državama članicama i promatračima 0,2 EPRV-a 0,010 0,018 0,025
English: Where an opinion by the Authority is required in accordance with Article 3(2) of this Regulation, the Authority shall assess the confidentiality request submitted by the applicant, in accordance with Articles 39 to 39f of Regulation (EC) No 178/2002.
Croatian: Ako se zahtijeva mišljenje Agencije u skladu s člankom 3. stavkom 2. ove Uredbe, Agencija ocjenjuje zahtjev za povjerljivost koji je podnio podnositelj zahtjeva, u skladu s člancima 39. do 39.f Uredbe (EZ) br. 178/2002.
English: Regulation (EC) No 1829/2003 is amended as follows:
Croatian: Uredba (EZ) br. 1829/2003 mijenja se kako slijedi:
English: Strengthened analysis of social science survey analysis 2 FTEs 0.103 0.181 0.258
Croatian: Ojačana analiza istraživanja u području društvenih znanosti 2 EPRV-a 0,103 0,181 0,258
English: It is proposed to lay down in legislation the objectives and general principles governing risk communication, taking into account the respective roles of risk assessors and managers pursuant to Article 40 of Regulation (EC) No 178/2002 and, based on these objectives and general principles, to draw up a general plan on risk communication ("general plan").
Croatian: Uredbe (EZ) br. 178/2002, i da se na temelju tih ciljeva i općih načela sastavi opći plan obavješćivanja o riziku („opći plan").
English: Article 32c
Croatian: Članak 32.c
English: [37: Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p.
Croatian: [37: Uredba (EZ) br. 45/2001 Europskog parlamenta i Vijeća od 18. prosinca 2000. o zaštiti pojedinaca u vezi s obradom osobnih podataka u institucijama i tijelima Zajednice i o slobodnom kretanju takvih podataka (SL L 8, 12.1.2001., str. 1.).]
English: In accordance with the conditions and the procedures laid down in Article 39 to 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, and this article,
Croatian: U skladu s uvjetima i postupcima iz članka 39. do 39.f Uredbe (EZ) br. 178/2002, koji se primjenjuju mutatis mutandis, i ovog članka,
English: Payments (3b) 19.512 34.145 48.779 48.779 48.779 199.994
Croatian: Plaćanja (3b) 19,512 34,145 48,779 48,779 48,779 199,994
English: Regulation (EC) No 178/2002 is amended as follows:
Croatian: Uredba (EZ) br. 178/2002 mijenja se kako slijedi:
English: (1) in Article 6, the following paragraph 5 is added:
Croatian: (1) u članku 6. dodaje se sljedeći stavak 5.:
English: Article 7
Croatian: Članak 7.
English: TOTAL COST 19.512 34.145 48.779 48.779 48.779 199.994
Croatian: UKUPNI TROŠAK 19,512 34,145 48,779 48,779 48,779 199,994
English: Article 32d
Croatian: Članak 32.d
English: (6) Article 39 is replaced by the following:
Croatian: (6) članak 39. zamjenjuje se sljedećim:
English: Article 11
Croatian: Članak 11.
English: Management mode(s) planned
Croatian: Predviđene metode upravljanja
English: X The proposal/initiative requires the use of appropriations of an administrative nature, as explained below:
Croatian: X Za prijedlog/inicijativu potrebna su sljedeća odobrena administrativna sredstva:
English: AD Total
Croatian: AD ukupno
English: X The proposal/initiative requires the use of operational appropriations, as explained below:
Croatian: X Za prijedlog/inicijativu potrebna su sljedeća odobrena sredstva za poslovanje:
English: (b) in paragraph 3 point (l) is replaced by the following:
Croatian: (b) u stavku 3. točka (l) zamjenjuje se sljedećim:
English: (8) in Article 40, the second subparagraph of paragraph 3 is replaced by the following:
Croatian: (8) U članku 40. drugi podstavak stavka 3. zamjenjuje se sljedećim:
English: (a) the following sentence is added at the end of the first paragraph:
Croatian: (a) na kraju prvog stavka dodaje se sljedeća rečenica:
English: It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority.
Croatian: Da bi se osigurala najkvalitetnija znanstvena ocjena Agencije, ključno je da zahtjev za odobrenje podnesen Agenciji na procjenu rizika ispunjava važeće specifikacije.
English: Where the Commission requests its opinion in accordance with Articles 10(3) and 16 of this Regulation, the Authority shall assess the confidentiality request submitted by the applicant, in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002.
Croatian: Ako Komisija zahtijeva mišljenje Agencije u skladu s člankom 10. stavkom 3. i člankom 16. ove Uredbe, Agencija ocjenjuje zahtjev za povjerljivost koji je podnio podnositelj zahtjeva, u skladu s člancima 39. do 39.f Uredbe (EZ) br. 178/2002.
English: Article 8a
Croatian: „Članak 8.a
English: 2023 2024 esq. (see point 1.6) Total
Croatian: 2023. 2024. i naredne godine (vidjeti odjeljak 1.6.) Ukupno
English: Request for confidentiality
Croatian: Zahtjev za povjerljivost
English: (ii) ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 14 and 15.
Croatian: ii. osigurati javni pristup zahtjevu, relevantnim popratnim i svim dopunskim informacijama koje je dostavio podnositelj zahtjeva, u skladu s člancima 14. i 15.";
English: (8) in Article 23, the introductory sentence of paragraph 2 is replaced by the following:
Croatian: (8) u članku 23. uvodna rečenica stavka 2. zamjenjuje se sljedećim:
English: Article 32b
Croatian: Članak 32.b
English: Where the relevant Scientific Committee is consulted under paragraph 1, it shall make public the notification/application, relevant supporting information and any supplementary information supplied by the notifier/applicant, as well as its scientific opinions, in accordance with Article 38 and Articles 39 to 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, and Article 25 of this Directive.
Croatian: „4. U slučaju savjetovanja s relevantnim Znanstvenim odborom iz stavka 1., on objavljuje obavijest/zahtjev, relevantne popratne informacije i sve dopunske informacije koje je podnio podnositelj obavijesti/podnositelj zahtjeva, kao i svoja znanstvena mišljenja u skladu s člankom 38. i člancima 39. do 39.f Uredbe (EZ) br. 178/2002 koji se primjenjuju mutatis mutandis i člankom 25. ove Direktive.".
English: (ii) ensure public access to the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 19 and 20.
Croatian: ii. osigurati javni pristup zahtjevu, relevantnim popratnim i svim dopunskim informacijama koje je dostavio podnositelj zahtjeva, u skladu s člancima 19. i 20.";
English: (1) Article 7 is amended as follows:
Croatian: (1) Članak 7. mijenja se kako slijedi:
English: Regulation (EC) No 1831/2003 is amended as follows:
Croatian: Uredba (EZ) br. 1831/2003 mijenja se kako slijedi:
English: (11) Article 61 is replaced by the following:
Croatian: (11) članak 61. zamjenjuje se sljedećim:
English: Article 6
Croatian: Članak 6.
English: Register of commissioned studies 2 FTEs 0.103 0.181 0.258
Croatian: Registar naručenih studija 2 EPRV-a 0,103 0,181 0,258
English: Article 39c
Croatian: Članak 39.c
English: They also highlighted the need to ensure that the Commission proposal strengthens these elements while safeguarding the principles on which the EU food safety system is based.
Croatian: Istaknuli su i da je potrebno osigurati da se Prijedlogom Komisije ojačaju ti elementi i da se istodobno zaštite načela na kojima se temelji EU-ov sustav sigurnosti hrane.
English: [4: https://ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-chain_en ]
Croatian: [4: https://ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-chain_hr ]
English: For consistency, the Commission proposal would also amend other sectoral food legislation.
Croatian: Radi dosljednosti Prijedlogom Komisije izmijenilo bi se i drugo sektorsko zakonodavstvo u području hrane.
English: Transparency of industry studies
Croatian: Transparentnost studija iz industrije
English: The earlier the access to industry studies in the risk assessment process, the greater its impact on transparency.
Croatian: Što raniji pristup studijama iz industrije u procesu procjene rizika, to je veći njegov učinak na transparentnost.
English: Safeguarding confidentiality and intellectual property rights is fundamental in order to avoid hampering innovation and competitiveness.
Croatian: Zaštita povjerljivosti i prava intelektualnog vlasništva neophodna je za izbjegavanje narušavanja inovacija i konkurentnosti.
English: Capacity for more public resources to finance studies on food safety.
Croatian: Sposobnost za usmjeravanje veće količine javnih sredstava na financiranje studija o sigurnosti hrane.
English: [3: http://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-6265773 ]
Croatian: [3: http://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-6265773_hr ]
English: The latter also highlighted the potential negative impact on competitiveness and innovation, in particular on new substances due to risks relating to potential unfair use of disclosed data and concerns over intellectual property rights.
Croatian: Posljednje navedeni istaknuli su i mogući negativni učinak na konkurentnost i inovacije, osobito na nove tvari zbog rizika povezanih s mogućom nepoštenom uporabom otkrivenih podataka i zbog zabrinutosti oko prava intelektualnog vlasništva.
English: MS acknowledged the need for more coordination among all actors.
Croatian: Države članice prepoznale su potrebu za boljom koordinacijom svih sudionika.
English: Need to ensure the protection of confidential data and personal data.
Croatian: Nužnost osiguranja zaštite povjerljivih i osobnih podataka.
English: Citizens and stakeholders had the opportunity to provide feedback on a Commission roadmap from 20 December 2017 to 17 January 2018.
Croatian: Građani i dionici mogli su pružiti povratne informacije o planu Komisije od 20. prosinca 2017. do 17. siječnja 2018.
English: As regards the citizens who took part, 318 replies came from 26 MS, 10 came from a European Free Trade Association country and five from other non-EU countries.
Croatian: Kad je riječ o građanima koji su sudjelovali, 318 odgovora pristiglo je iz 26 država članica, 10 iz zemlje članice Europskog udruženja slobodne trgovine i pet iz ostalih trećih zemalja.
English: Industry stakeholders also highlighted the need to avoid unfair use of commercial data.
Croatian: Dionici iz industrije istaknuli su i potrebu za izbjegavanjem nepoštene uporabe trgovačkih podataka.
English: Scientific independence and excellence of experts are cornerstones of the EU risk assessment system.
Croatian: Znanstvena neovisnost i izvrsnost stručnjaka temelj su EU-ova sustava procjene rizika.
English: Risk Communication
Croatian: Obavješćivanje o riziku
English: Some MS expressed reservations on the potential added value of this measure.
Croatian: Određene države članice izrazile su suzdržanost u pogledu moguće dodane vrijednosti te mjere.
English: The Commission proposal would amend Regulation (EC) No 178/2002 which sets out the general principles and requirements of food law, establishing the European Food Safety Authority (EFSA) and defines procedures in matters of food safety.
Croatian: Prijedlogom Komisije izmijenila bi se Uredba (EZ) br. 178/2002 u kojoj su utvrđena opća načela i zahtjevi propisa o hrani, osnovana Europska agencija za sigurnost hrane (EFSA) te utvrđeni postupci u područjima sigurnosti hrane.
English: Feedback received during the consultations was not taken into account if it went beyond the scope of the Commission proposal.
Croatian: Nisu se uzimale u obzir povratne informacije primljene tijekom savjetovanja ako su se odnosile na pitanja izvan područja primjene Prijedloga Komisije.
English: Regarding the establishment of a register of industry studies, mainly MS authorities highlighted the challenges as regards applicability outside the EU.
Croatian: Kad je riječ o uspostavi registra studija iz industrije, uglavnom su tijela država članica istaknula izazove povezane s primjenjivosti izvan EU-a.
English: However, 27.7 % of citizen replies and 26.1 % of stakeholder replies disagree or strongly disagree with this statement.
Croatian: Međutim, 27,7 % građana i 26,1 % dionika izražava neslaganje ili snažno neslaganje s tom izjavom.
English: As consumers may in general lack the scientific knowledge to use these studies, consumer organisations suggested that trust would depend on other factors, e.g. third-party scrutiny of the studies.
Croatian: Budući da potrošači uglavnom nemaju dovoljno znanstvenih spoznaja da bi mogli upotrijebiti te studije, organizacije potrošača ukazale su na to da povjerenje ovisi o drugim čimbenicima, npr. kontroli studija koju provode treće strane.
English: The contributions to the different consultations showed a need to consider the following when preparing the Commission proposal:
Croatian: Odgovori u različitim savjetovanjima pokazali su da se u pripremi Prijedloga Komisije trebaju razmotriti sljedeća pitanja:
English: Industry organisations commented that there is a risk of the published data being misuse.
Croatian: Industrijske organizacije napomenule su da postoji rizik od zlouporabe objavljenih podataka.
English: Adequate incentives are needed in order to ensure that EFSA obtains the expertise it needs from MS.
Croatian: Potrebni su odgovarajući poticaji kako bi EFSA iz država članica dobila stručno znanje koje joj je potrebno.
English: Targeted consultations with specific stakeholder groups also took place.
Croatian: Održano je i ciljano savjetovanje sa specifičnim skupinama dionika.
English: In addition, both citizens (75.2 %) and stakeholders (79.7 %) agree or strongly agree that the costs of national bodies' scientific contribution to EFSA's tasks should be adequately compensated.
Croatian: Osim toga, i građani (75,2 %) i dionici (79,7 %) slažu se ili se izrazito slažu da bi se troškovi znanstvenog doprinosa nacionalnih tijela zadaćama EFSA-e trebali nadoknaditi na odgovarajući način.
English: EU-level stakeholder organisations representing farmers, cooperatives, the food industry, retailers, consumers, professionals and civil society were consulted in a working group meeting of the Advisory Group on the Food Chain and Animal and Plant Health.
Croatian: Savjetovanje s organizacijama dionika na razini EU-a koje zastupaju poljoprivrednike, zadruge, prehrambenu industriju, trgovce na malo, potrošače, stručnjake i civilno društvo održano je na sastanku radne skupine Savjetodavna skupina za prehrambeni lanac i zdravlje životinja i biljaka.
English: The stakeholders that took part represented a variety of sectors: trade and business associations (39.22 %), companies and groups (14.38 %), NGOs (13.07 %), professional associations (8.5 %), national/regional authorities (8.5 %), governmental agencies (5.23 %), research institutes (3.92 %), public bodies (1.96 %), professional consultancies (1.96 %), think-tanks (1.31 %), law firms (0.65 %), EU Institutions (0.65 %), and other (0.65 %).
Croatian: Dionici koji su sudjelovali zastupali su različite sektore: trgovačke i poslovne udruge (39,22 %), poduzeća i grupe (14,38 %), nevladine organizacije (13,07 %), stručna udruženja (8,5 %), nacionalna/regionalna tijela (8,5 %), vladine agencije (5,23 %), istraživačke institute (3,92 %), javna tijela (1,96 %), stručna konzultantska društva (1,96 %), skupine za strateško promišljanje (1,31 %), odvjetnička društva (0,65 %), institucije EU-a (0,65 %) i ostale entitete (0,65 %).
English: The other financing options proposed, i.e. the EU budget, common funding provided by all industry applicants or a combination of public and industry funding, were considered relevant by 32.1 %, 27 % and 25.2 % of citizens, respectively.
Croatian: Ostale predložene mogućnosti financiranja, tj. proračun EU-a, zajedničko financiranje koje pružaju svi podnositelji zahtjeva iz industrije ili kombinacija javnih sredstava i sredstava iz industrije, relevantnima smatra 32,1 %, 27 % odnosno 25,2 % građana.
English: The information that EFSA makes public on its activities and contributions was also judged as very important.
Croatian: Vrlo su se važnim smatrale i informacije koje EFSA objavljuje o svojim aktivnostima i doprinosima.
English: Consultations also took place via the EFSA Advisory Forum (national food safety authorities) and the Commission Expert Group on General Food Law and with the Scientific Committee of EFSA.
Croatian: Savjetovanja su održana i u okviru Savjetodavnog vijeća EFSA-e (nacionalna tijela za sigurnost hrane) i Stručne skupine Komisije za opće propise o hrani te sa Znanstvenim odborom EFSA-e.
English: This was followed by an open public consultation (OPC), targeting citizens and stakeholders, open from 23 January 2018 to 20 March 2018.
Croatian: Nakon toga uslijedilo je otvoreno javno savjetovanje usmjereno na građane i dionike od 23. siječnja 2018. do 20. ožujka 2018.
English: Details on what information from industry studies can be claimed as confidential need to be clear, and the related claims must be thoroughly assessed.
Croatian: Podaci o tome koje se informacije iz studija iz industrije mogu smatrati povjerljivima moraju biti jasni, a s time povezani zahtjevi moraju se temeljito procijeniti.
English: This report covers feedback from citizens and national authorities, groups and organisations (‘stakeholders') as regards the initiative for a Commission proposal for a Regulation on the transparency and sustainability of the EU risk assessment in the food chain (‘Commission proposal').
Croatian: Ovo izvješće obuhvaća povratne informacije građana i nacionalnih tijela, grupa i organizacija („dionici") o inicijativi za Komisijin Prijedlog uredbe o transparentnosti i održivosti EU-ove procjene rizika u lancu opskrbe hranom („Prijedlog Komisije").