qanastek/ELRC-Medical-V2 huggingface dataset:
English: Targeted changes are proposed to align the composition of the Management Board of EFSA and the procedure for the external evaluation of EFSA to the Common Approach set out in the annex to the 2012 inter-institutional joint statement on Union decentralised agencies.
Translation (en-hr): Predlažu se ciljane promjene kako bi se sastav Upravnog vijeća EFSA-e i postupak za vanjsku procjenu EFSA-e uskladili sa zajedničkim pristupom utvrđenim u prilogu međuinstitucionalnoj zajedničkoj izjavi o decentraliziranim agencijama Unije iz 2012.
English: (7) the following Articles 39a to 39g are inserted:
Translation (en-hr): (7) umeću se sljedeći članci od 39.a do 39.g:
English: (c) any other information deemed confidential within the specific procedural rules referred to in Article 5(1)(n) of this Regulation.
Translation (en-hr): (c) sve druge informacije koje se smatraju povjerljivima u skladu s posebnim pravilima postupanja iz članka 5. stavka 1. točke (n) ove Uredbe.";
English: The register of commissioned studies will have a positive impact on the objectivity of the evidence submitted by industry since it will provide additional guarantee that applicants submit all studies they have performed on a substance -whatever their results.
Translation (en-hr): Registar naručenih studija pozitivno će utjecati na objektivnost dokaza iz industrije jer će pružati dodatno jamstvo da su podnositelji zahtjeva podnijeli sve studije koje su proveli na određenoj tvari neovisno o njihovim rezultatima.
English: There are no negative impacts in the duration of authorisation procedures since this is a parallel activity.
Translation (en-hr): Ne postoje negativni učinci na trajanje postupaka odobrenja jer je riječ o aktivnosti koja se istodobno odvija.
English: The consultation on submitted studies does not create additional burdens since the obligation to submit studies to EFSA, Commission and Member States already exists.
Translation (en-hr): Savjetovanje o podnesenim studijama ne stvara dodatno opterećenje jer već postoji obveza podnošenja studija EFSA-i, Komisiji i državama članicama.
English: (1) Regulation (EC) No 178/2002 of the European Parliament and of the Council lays down the general principles and requirements of food law, so as to form a common basis for measures governing food law both at Union and Member State level.
Translation (en-hr): (1) Uredbom (EZ) br. 178/2002 Europskog parlamenta i Vijeća utvrđuju se opća načela i zahtjevi propisâ o hrani, u cilju stvaranja zajedničke osnove za mjere kojima se uređuje područje propisa o hrani i na razini Unije i na razini država članica.
English: The studies commissioned may have a wider scope than the evidence subject to verification.
Translation (en-hr): Naručene studije mogu imati širi opseg od dokaza koji su predmet provjere.";
English: (8) The general plan should identify the key factors to be taken into account when risk communications' activities are considered, such as the different levels of risk, the nature of the risk and its potential public health impact, who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context.
Translation (en-hr): (8) Tim općim planom trebalo bi utvrditi ključne čimbenike koje treba uzeti u obzir pri razmatranju mjera obavješćivanja o rizicima, kao što su različite razine rizika, vrsta rizika i mogući učinak na javno zdravlje, koga i što rizik izravno i neizravno pogađa, razine izloženosti riziku, mogućnost kontrole rizika i drugi čimbenici koji utječu na percepciju rizika, uključujući stupanj hitnosti, kao i mjerodavni zakonodavni okvir i relevantni kontekst tržišta.
English: The contributions received from citizens and stakeholders confirmed the importance of the aspects of the Union food safety risk assessment model this proposal addresses and the need to ensure that the proposal strengthens all those aspects, while safeguarding the principles on which the Union food safety system is based.
Translation (en-hr): Odgovori građana i dionika potvrdili su važnost aspekata EU-ova modela za procjenu rizika za sigurnost hrane na koje se odnosi ovaj prijedlog te potrebu da se u okviru prijedloga osigura jačanje svih tih aspekata i istodobna zaštita načela na kojima se temelji EU-ov sustav sigurnosti hrane.
English: [Body]: <EFSA.> Year
Translation (en-hr): [Tijelo]: <EFSA.>
English: Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available).
Translation (en-hr): Treba voditi računa o činjenici da će se u nekim posebnim slučajevima naručiti studije čiji opseg može biti širi od samih nalaza koji su predmet provjere (naprimjer na temelju novog razvoja znanosti).
English: The potential impact of revealing the business strategy of a company by the notification of commissioned studies on a new substance has been neutralised since this information is made public only when the studies included in the corresponding authorisation application are made public so at a time where such a publication cannot have the effect to reveal a business strategy.
Translation (en-hr): Mogući učinak otkrivanja poslovne strategije poduzeća obavješćivanjem o naručenim studijama o novoj tvari neutraliziran je jer su te informacije dostupne javnosti tek nakon što se studije priložene odgovarajućem zahtjevu za odobrenje javno objave, odnosno u trenutku kada njihova objava ne može utjecati na otkrivanje poslovne strategije.
English: (28) Accordingly and with respect to the procedures governing requests for authorisation procedures provided in Union food law, experience gained so far has shown that certain information items are generally considered sensitive and should remain confidential across the different sectoral authorisation procedures.
Translation (en-hr): (28) U skladu s tim i s obzirom na postupke kojima se uređuju zahtjevi za postupke odobravanja iz propisa Unije o hrani, dosad stečeno iskustvo pokazalo je da se određene informacije općenito smatraju osjetljivima i trebale bi ostati povjerljive u postupcima odobravanja u različitim sektorima.
English: Risk assessment at Union level is carried out by an autonomous agency established by the GFL Regulation, the European Food Safety Authority (EFSA), separately from the risk management function of the Union Institutions, and mainly that of the Commission.
Translation (en-hr): Procjenu rizika na razini Unije provodi nezavisna agencija osnovana Uredbom o općim načelima zakona o hrani, Europska agencija za sigurnost hrane (EFSA), koja je odvojena od funkcije upravljanja rizikom institucija Unije i osobito funkcije upravljanja rizikom Komisije.
English: Activity: [General Food Law]
Translation (en-hr): Aktivnost: [Opći propisi o hrani]
English: As explained in the Explanatory Memorandum of the latter proposal, the Commission did not include in its horizontal alignment legislative proposal, amongst others, Regulation (EC) No 1935/2004, Regulation (EC) No 1331/2008 and Regulation (EC) No 1107/2009, as it is reflecting on whether there is a more appropriate way to structure these acts as concerns individual authorisations/setting of values/listing of specific substances based on the specific criteria set out in those acts, bearing in mind the improved approach adopted by the co-legislators in the context of Regulation (EU) 2015/2283 and the ongoing REFIT reviews of Regulation (EC) No 1935/2004 and Regulation (EC) No 1107/2009.
Translation (en-hr): Kako je objašnjeno u obrazloženju tog prijedloga, Komisija u svoj zakonodavni prijedlog o horizontalnom usklađivanju nije uključila, među ostalim, Uredbu (EZ) br. 1935/2004, Uredbu (EZ) br. 1331/2008 i Uredbu (EZ) br. 1107/2009 jer razmatra postoji li primjereniji način strukturiranja tih akata u pogledu pojedinačnih odobrenja / određivanja vrijednosti / popisivanja određenih tvari na temelju posebnih kriterija utvrđenih u tim aktima, a pritom uzima u obzir poboljšani pristup koji su suzakonodavci donijeli u kontekstu Uredbe (EU) 2015/2283 i preispitivanja Uredbe (EZ) br. 1935/2004 i Uredbe (EZ) br. 1107/2009 u okviru programa REFIT koja su u tijeku.
English: (39) The appointment of the Scientific Committee and Scientific Panels' members being dependent of the entry in function of the new Management Board, it is necessary to provide for specific transitional provisions allowing a prolongation of the current term of office of the members of the Scientific Committee and Scientific Panels members.
Translation (en-hr): (39) Budući da je za imenovanje članova Znanstvenog odbora i znanstvenih panela potrebno da novo Upravnog vijeće preuzme dužnost, nužno je utvrditi posebne prijelazne odredbe koje dopuštaju produženje tekućeg mandata članova Znanstvenog odbora i znanstvenih panela.
English: The impact on the duration of the authorisation procedures is minimal since this procedure is at the pre-submission stage and it may have a positive impact in reducing the length of authorisation procedures, as concerns may be raised and addressed early on in the process.
Translation (en-hr): Učinak na trajanje postupaka odobrenja minimalan je jer se taj postupak odvija u fazi prije podnošenja zahtjeva, a mogao bi i pozitivno utjecati na smanjenje trajanja postupaka odobrenja jer bi se problemi mogli otkriti i riješiti u ranoj fazi postupka.
English: Nevertheless, the following challenges have been identified: national differences in the implementation of the GFL Regulation at Member State level have been observed, creating in some instances uneven playing field for businesses; a perceived lack of transparency of the risk analysis process; risk communication is, overall, considered not to be effective enough, thus creating a negative impact on consumers' confidence and on the acceptability of risk management decisions; certain limitations in EFSA's capacity to ensure in the long-term sufficient expertise and to fully engage all Member States in scientific cooperation; lengthy authorisation procedures in some sectors.
Translation (en-hr): Unatoč tomu, utvrđeni su sljedeći izazovi: uočene nacionalne razlike u provedbi Uredbe o općim propisima o hrani na razini država članica koje u određenim slučajevima stvaraju nejednake tržišne uvjete za poduzeća, percipirani nedostatak transparentnosti procesa analize rizika, općenita nedovoljna djelotvornost obavješćivanja o riziku koja negativno utječe na povjerenje potrošača i prihvatljivost odluka o upravljanju rizikom, određena ograničenja sposobnosti EFSA-e da dugoročno osigura dovoljni broj stručnjaka i u potpunosti uključi sve države članice u znanstvenu suradnju, dugotrajni postupci odobrenja u određenim sektorima.
English: These developments took place against the backdrop of public controversy over the approach towards the assessment and management of sensitive substances such as genetically modified organisms, and plant protection products, especially those containing glyphosate or potentially negative health impacts arising from endocrine disruptors.
Translation (en-hr): Sve se to odvijalo u kontekstu kontroverzije u javnosti u pogledu načina na koji se pristupa procjeni osjetljivih tvari, primjerice genetski modificiranih organizama, i upravljanju tim tvarima te sredstvima za zaštitu bilja, osobito onima koja sadrže glifosate ili bi mogli negativno utjecati na zdravlje zbog endokrinih disruptora.
English: Citizens / civil society perceive the risk assessment process as opaque and demand more transparency, due to several different transparency and confidentiality rules applicable to risk assessment and decision-making process, making the system complex and non-uniform.
Translation (en-hr): Građani / civilno društvo smatraju da je proces procjene rizika netransparentan i traže veću transparentnost jer postoji nekoliko različitih pravila o transparentnosti i povjerljivosti koja su primjenjiva na proces procjene rizika i donošenje odluka zbog čega je sustav složen i neujednačen.
English: (a) any information provided in detailed descriptions of starting substances and preparations used to manufacture the substance subject to the authorisation, the composition of preparations, materials or articles in which the applicant intends to use this substance, the manufacturing methods of these preparations, materials or articles, impurities, and migration testing results;
Translation (en-hr): (a) sve informacije pružene u detaljnim opisima ishodišnih tvari i pripravaka koji se upotrebljavaju za proizvodnju tvari koja podliježe odobrenju, sastava pripravaka, materijala ili predmeta u kojima podnositelj zahtjeva namjerava iskoristiti tu tvar, metoda proizvodnje tih proizvoda, materijala ili predmeta, nečistoća, i rezultata ispitivanja migracije;
English: Regulatory fitness and simplification
Translation (en-hr): Primjerenost propisa i pojednostavljivanje
English: 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.
Translation (en-hr): Zato je nužno da ravnatelj, čija je zadaća braniti interese EFSA-e, a posebno neovisnost njezinih stručnih mišljenja, ima ulogu u odabiru i imenovanju tih znanstvenih stručnjaka.
English: The power to adopt delegated acts is conferred upon the Commission subject to the conditions laid down in this Article.
Translation (en-hr): Ovlast za donošenje delegiranih akata dodjeljuje se Komisiji podložno uvjetima utvrđenima u ovom članku.
English: The possibility to ask the EFSA to exceptionally commission studies: This is an additional tool where scientific evidence upon which EFSA relies needs to be verified.
Translation (en-hr): Mogućnost podnošenja zahtjeva EFSA-i za izvanredno naručivanje studija: to je dodatan alat ako se moraju provjeriti znanstveni dokazi na koje se EFSA oslanja.
English: The list of information referred to in paragraph 2 shall be without prejudice to any specific Union food law.
Translation (en-hr): Popis informacija iz stavka 2. ne dovodi u pitanje nijedan propis Unije o hrani.
English: Commitment appropriations in EUR million (to three decimal places)
Translation (en-hr): Odobrena sredstva za preuzete obveze u milijunima EUR (do 3 decimalna mjesta)
English: As confirmed in the recently published Fitness Check of the GFL Regulation (GFL Fitness Check), the rigorous implementation of the risk analysis principle throughout the Union law has overall raised the level of protection from potential food safety risks in a number of ways.
Translation (en-hr): Kako je potvrđeno u nedavno objavljenoj provjeri primjerenosti Uredbe o općim propisima o hrani, stroga provedba načela analize rizika u okviru zakonodavstva Unije općenito je na mnoge načine podigla razinu zaštite od mogućih rizika za sigurnost hrane.
English: (e) the annual declarations of interest made by members of the Management Board, the Executive Director, members of the Advisory Forum and members of the Scientific Committee, Scientific Panels and of their Working Groups, as well as the declarations of interest made in relation to items on the agendas of meetings;
Translation (en-hr): (e) godišnjim izjavama o sukobu interesa članova Upravnog vijeća, ravnatelja, članova Savjetodavnog vijeća i članova Znanstvenog odbora i znanstvenih panela i njihovih radnih skupina, kao i izjavama o sukobu interesa u vezi s točkama dnevnog reda sastanaka;
English: (b) Member States shall nominate experts with a view to collectively reach the number indicated by the Executive Director.
Translation (en-hr): (b) Države članice nominiraju stručnjake tako da sve zajedno nominiraju ukupan broj naveden u zahtjevu ravnatelja.
English: The Authority shall lay down in its internal rules the practical arrangement for implementing the procedures referred to in Articles 32a and this Article.
Translation (en-hr): Agencija u svojim internim pravilima utvrđuje praktični postupak provedbe postupaka iz članka 32.a i ovog članka.
English: It is therefore essential to maintain the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation and independence of the Authority and transparency.
Translation (en-hr): Stoga je veoma važno sačuvati povjerenje šire javnosti i drugih zainteresiranih strana u proces analize rizika na kojemu se temelje propisi Unije o hrani, a posebno u procjenu rizika, uključujući organizaciju i neovisnost Agencije.
English: On transparency, the measures envisaged (i.e. proactive disclosure of non-confidential data, register of commissioned studies, voluntary pre-submission procedure, pre-notification of, and advice on planned studies in case of renewals, consultation of third parties on submitted studies) provide a robust framework which is proportional to the objective of enhancing citizens' confidence in the transparency of the system.
Translation (en-hr): Mjere predviđene za transparentnost (tj. proaktivno otkrivanje podataka koji nisu povjerljivi, registar naručenih studija, dobrovoljni postupak prije podnošenja zahtjeva za nove tvari, prethodno obavješćivanje i davanje mišljenja o planiranim studijama u slučaju produljenja, savjetovanje s trećim stranama o podnesenim studijama) pružaju čvrst okvir koji je razmjeran cilju povećavanja povjerenja građana u transparentnost sustava.
English: The impact on the timing of authorisation is minimal as detailed for each measure.
Translation (en-hr): Učinak na vrijeme davanja odobrenja minimalan je kako je navedeno za svaku mjeru.
English: Decisions taken by the Authority pursuant to this Article may be subject to an action before the Court of Justice of the European Union, under the conditions laid down in Articles 263 and 278 of the Treaty respectively.
Translation (en-hr): Protiv odluke Agencije u skladu s ovim člankom može se podnijeti tužba Sudu Europske unije pod uvjetima utvrđenima člankom 263. odnosno člankom 278.
English: Alternate members shall represent the member in his absence and vote on his behalf.
Translation (en-hr): U slučaju odsutnosti člana zamjenjuje ga zamjenik i glasa u njegovo ime.";
English: Confidentiality
Translation (en-hr): Povjerljivost
English: Total 8.5 14.9 21.2 21.2 21.2
Translation (en-hr): Ukupno 8,5 14,9 21,2 21,2 21,2
English: (b) any provisions set out in Union food law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations (‘data exclusivity rules').
Translation (en-hr): (b) odredbe utvrđene u okviru propisa Unije o hrani kojima se štite ulaganja inovatora u prikupljanje informacija i podataka kojima se potkrepljuju relevantni zahtjevi za odobrenje (‚pravila o zaštiti podataka').
English: Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, and 168(4)(b) thereof,
Translation (en-hr): uzimajući u obzir Ugovor o funkcioniranju Europske unije, a posebno njegov članak 43., članak 114. i članak 168. stavak 4. točku (b),
English: (c) the names of all participants in meetings of the Scientific Committee and the Scientific Panels and their Working Groups.
Translation (en-hr): (c) imena svih sudionika sastanaka Znanstvenog odbora i znanstvenih panela i njihovih radnih skupina.
English: Members of the Management Board, the Executive Director, members of the Scientific Committee and Scientific Panels as well as external experts participating in their working groups, members of the Advisory Forum and members of the staff of the Authority, even after their duties have ceased, shall be subject to the requirements of confidentiality pursuant to Article 339 of the Treaty.
Translation (en-hr): Članovi Upravnog vijeća, ravnatelj, članovi Znanstvenog odbora i znanstvenih panela, kao i vanjski stručnjaci koji sudjeluju u radu radnih skupina, članovi Savjetodavnoga vijeća i osoblje Agencije, pridržavaju se obveze tajnosti čak i nakon prestanka svoje dužnosti, sukladno članku 339.
English: Notwithstanding paragraph 1, disclosure of names and addresses of natural persons involved in testing on vertebrate animals or in obtaining toxicological information shall be deemed to significantly harm the privacy and the integrity of those natural persons and shall not be made publicly available, unless there is an overriding public interest.
Translation (en-hr): Ne dovodeći u pitanje stavak 1., smatra se da objavljivanje imena i adresa fizičkih osoba koje sudjeluju u provođenju pokusa na kralježnjacima ili u dobivanju toksikoloških informacija može nanijeti znatnu štetu privatnosti i integritetu tih fizičkih osoba i stoga se ta imena i adrese ne objavljuju, osim ako postoji prevladavajući javni interes.
English: (36) To ensure that sectoral specificities with respect to confidential information are taken into account, it is necessary to weigh up the relevant rights of the public to transparency in the risk assessment process, including those flowing from the Aarhus Convention, against the rights of commercial applicants, taking into account the specific objectives of sectoral Union legislation as well as experienced gained.
Translation (en-hr): (36) Da bi se u obzir uzele sektorske posebnosti u pogledu povjerljivih informacija, nužno je odvagnuti relevantna prava javnosti na transparentnost u procesu procjene rizika, uključujući ona koja proizlaze iz Aarhuške konvencije, u odnosu na prava komercijalnih podnositelja zahtjeva, uzimajući u obzir posebne ciljeve sektorskog zakonodavstva Unije kao i stečena iskustva.
English: The Commission shall without delay inform the Member States and forward the application to the European Food Safety Authority (hereinafter referred to as the Authority).
Translation (en-hr): Komisija bez odlaganja obavještava države članice i prosljeđuje zahtjev Europskoj agenciji za sigurnost hrane (dalje u tekstu Agencija).";
English: Seconded National Experts
Translation (en-hr): Upućeni nacionalni stručnjaci
English: Moreover, as indicated in the GFL Fitness Check, food and feed safety measures have the greatest effect when taken at Union level.
Translation (en-hr): Nadalje, kako je navedeno u provjeri primjerenosti općih propisa o hrani, mjere za sigurnost hrane i hrane za životinje najdjelotvornije su kada se poduzimaju na razini Unije.
English: (c) inform the applicant in writing of its intention to disclose information and the reasons for it, before the Authority formally takes a decision on the confidentiality request.
Translation (en-hr): (c) uputiti pisanu obavijest podnositelju zahtjeva o svojoj namjeri da objavi informacije i razlozima za to, i to prije formalnog donošenja odluke o zahtjevu za povjerljivost.
English: The Commission experts shall perform controls, including audits, to obtain assurance that testing facilities comply with relevant standards for carrying out tests and studies submitted to the Authority as part of an application for an authorisation under Union food law.
Translation (en-hr): Stručnjaci Komisije provode kontrole, uključujući revizije, da provjere jesu li objekti u kojima se provodi ispitivanje u skladu s relevantnim standardima za provedbu ispitivanja i studija koje se dostavljaju Agenciji u sklopu zahtjeva za odobrenje prema propisima Unije o hrani.
English: The delegation of power referred to in Article 8(c) may be revoked at any time by the European Parliament or by the Council.
Translation (en-hr): Europski parlament ili Vijeće u svakom trenutku mogu opozvati delegiranje ovlasti iz članka 8. točke (c).