qanastek/ELRC-Medical-V2 huggingface dataset:
English: (c) in paragraph 3 the following point (m) is added:
Translation (en-hr): (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).]
Translation (en-hr): [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
Translation (en-hr): „Članak 20.
English: risk communication
Translation (en-hr): Obavješćivanje o riziku
English: It shall:
Translation (en-hr): 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.
Translation (en-hr): 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
Translation (en-hr): Funkcijska skupina III.
English: (a) in paragraph 3 the introductory sentence is replaced by the following:
Translation (en-hr): (a) u stavku 3. uvodna rečenica zamjenjuje se sljedećim:
English: Payments (2) 5.490 9.608 13.726 13.726 13.726 56.276
Translation (en-hr): 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:
Translation (en-hr): (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.
Translation (en-hr): „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.
Translation (en-hr): (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
Translation (en-hr): 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:
Translation (en-hr): (b) na kraju drugog stavka dodaje se sljedeća rečenica:
English: Article 9
Translation (en-hr): 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.
Translation (en-hr): 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
Translation (en-hr): Članak 39.d
English: "Article 16
Translation (en-hr): „Članak 16.
English: Article 39f
Translation (en-hr): Članak 39.f
English: MB with MSs & observers 0.2 FTEs 0.010 0.018 0.025
Translation (en-hr): 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.
Translation (en-hr): 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:
Translation (en-hr): 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
Translation (en-hr): 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").
Translation (en-hr): 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
Translation (en-hr): 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.
Translation (en-hr): [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,
Translation (en-hr): 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
Translation (en-hr): Plaćanja (3b) 19,512 34,145 48,779 48,779 48,779 199,994
English: Regulation (EC) No 178/2002 is amended as follows:
Translation (en-hr): Uredba (EZ) br. 178/2002 mijenja se kako slijedi:
English: (1) in Article 6, the following paragraph 5 is added:
Translation (en-hr): (1) u članku 6. dodaje se sljedeći stavak 5.:
English: Article 7
Translation (en-hr): Članak 7.
English: TOTAL COST 19.512 34.145 48.779 48.779 48.779 199.994
Translation (en-hr): UKUPNI TROŠAK 19,512 34,145 48,779 48,779 48,779 199,994
English: Article 32d
Translation (en-hr): Članak 32.d
English: (6) Article 39 is replaced by the following:
Translation (en-hr): (6) članak 39. zamjenjuje se sljedećim:
English: Article 11
Translation (en-hr): Članak 11.
English: Management mode(s) planned
Translation (en-hr): Predviđene metode upravljanja
English: X The proposal/initiative requires the use of appropriations of an administrative nature, as explained below:
Translation (en-hr): X Za prijedlog/inicijativu potrebna su sljedeća odobrena administrativna sredstva:
English: AD Total
Translation (en-hr): AD ukupno
English: X The proposal/initiative requires the use of operational appropriations, as explained below:
Translation (en-hr): X Za prijedlog/inicijativu potrebna su sljedeća odobrena sredstva za poslovanje:
English: (b) in paragraph 3 point (l) is replaced by the following:
Translation (en-hr): (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:
Translation (en-hr): (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:
Translation (en-hr): (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.
Translation (en-hr): 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.
Translation (en-hr): 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
Translation (en-hr): „Članak 8.a
English: 2023 2024 esq. (see point 1.6) Total
Translation (en-hr): 2023. 2024. i naredne godine (vidjeti odjeljak 1.6.) Ukupno
English: Request for confidentiality
Translation (en-hr): 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.
Translation (en-hr): 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:
Translation (en-hr): (8) u članku 23. uvodna rečenica stavka 2. zamjenjuje se sljedećim:
English: Article 32b
Translation (en-hr): 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.
Translation (en-hr): „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.
Translation (en-hr): 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:
Translation (en-hr): (1) Članak 7. mijenja se kako slijedi:
English: Regulation (EC) No 1831/2003 is amended as follows:
Translation (en-hr): Uredba (EZ) br. 1831/2003 mijenja se kako slijedi:
English: (11) Article 61 is replaced by the following:
Translation (en-hr): (11) članak 61. zamjenjuje se sljedećim:
English: Article 6
Translation (en-hr): Članak 6.
English: Register of commissioned studies 2 FTEs 0.103 0.181 0.258
Translation (en-hr): Registar naručenih studija 2 EPRV-a 0,103 0,181 0,258
English: Article 39c
Translation (en-hr): 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.
Translation (en-hr): 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 ]
Translation (en-hr): [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.
Translation (en-hr): Radi dosljednosti Prijedlogom Komisije izmijenilo bi se i drugo sektorsko zakonodavstvo u području hrane.
English: Transparency of industry studies
Translation (en-hr): Transparentnost studija iz industrije
English: The earlier the access to industry studies in the risk assessment process, the greater its impact on transparency.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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 ]
Translation (en-hr): [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.
Translation (en-hr): 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.
Translation (en-hr): Države članice prepoznale su potrebu za boljom koordinacijom svih sudionika.
English: Need to ensure the protection of confidential data and personal data.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): Znanstvena neovisnost i izvrsnost stručnjaka temelj su EU-ova sustava procjene rizika.
English: Risk Communication
Translation (en-hr): Obavješćivanje o riziku
English: Some MS expressed reservations on the potential added value of this measure.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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:
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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 %).
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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.
Translation (en-hr): 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.