natgillin/translations-raw huggingface dataset:
Hence Directive (EU) 2015/849 provides that the Commission should identify high-risk third countries which present strategic deficiencies in their regimes on anti-money-laundering and countering terrorist financing that pose significant threats to the financial system of the Union.
Unija mora osigurati učinkovitu zaštitu cjelovitosti i pravilnog funkcioniranja svojeg financijskog sustava i unutarnjeg tržišta od pranja novca i financiranja terorizma.
The Commission should review the list of high-risk third countries listed in Delegated Regulation (EU) 2016/1675 at appropriate times in light of the progress made by those high-risk third countries in removing the strategic deficiencies in their regime on anti-money-laundering and countering terrorist financing (‘AML/CFT’).
Stoga se Direktivom (EU) 2015/849 predviđa da bi Komisija trebala utvrditi visokorizične treće zemlje sa strateškim nedostacima u svojem režimu sprečavanja pranja novca i borbe protiv financiranja terorizma koji predstavljaju znatnu prijetnju financijskom sustavu Unije.
The Commission should take account in its assessments of new information from international organisations and standard-setters, such as those issued by the Financial Action Task Force (FATF).
Komisija bi trebala pravodobno revidirati popis visokorizičnih trećih zemalja navedenih u Delegiranoj uredbi (EU) 2016/1675 s obzirom na napredak koji su ostvarile te visokorizične treće zemlje u uklanjanju strateških nedostataka u svojem režimu sprečavanja pranja novca i financiranja terorizma (SPNFT).
In light of this information, the Commission should also identify additional high-risk third countries presenting strategic deficiencies in their AML/CFT regime.
Komisija bi u svojim procjenama trebala uzeti u obzir nove informacije međunarodnih organizacija i stručnjaka zaduženih za određivanje standarda, poput onih koje izdaje Radna skupina za financijsko djelovanje (FATF).
In line with the criteria set out in Directive (EU) 2015/849, the Commission took into account the recent available information, in particular recent FATF Public Statements and the FATF document ‘Improving Global AML/CFT Compliance: ongoing process’, and FATF reports of the International Cooperation Review Group in relation to the risks posed by individual third countries in line with Article 9(4) of Directive (EU) 2015/849.
Uzimajući u obzir te informacije, Komisija bi trebala utvrditi i dodatne visokorizične treće zemlje sa strateškim nedostacima u svojem režimu SPNFT-a.
The FATF identified Sri Lanka, Trinidad and Tobago, and Tunisia as having strategic AML/CFT deficiencies that pose a risk to the international financial system, for which they have developed an action plan with the FATF.
U skladu s kriterijima utvrđenima u Direktivi (EU) 2015/849 Komisija je uzela u obzir novije dostupne informacije, a posebice novije javne izjave FATF-a i dokument FATF-a „Poboljšanje globalne usklađenosti s mjerama sprečavanja pranja novca i borbe protiv financiranja terorizma: neprekidan proces” te izvješća Skupine FATF-a za preispitivanje međunarodne suradnje u vezi s rizicima koje predstavljaju pojedine treće zemlje u skladu s člankom 9. stavkom 4.
Considering the high level of integration of the international financial system, the close connection of market operators, the high volume of cross-border transactions to or from the Union, as well as the degree of market opening, the Commission hence considers that any AML/CFT threat posed to the international financial system also represents a threat for the Union financial system.
Direktive (EU) 2015/849.
In accordance with the latest relevant information, the Commission's analysis has concluded that Sri Lanka, Trinidad and Tobago, and Tunisia should be considered third-country jurisdictions which have strategic deficiencies in their AML/CFT regime that pose significant threats to the financial system of the Union in accordance with the criteria set out in Article 9 of Directive (EU) 2015/849.
FATF je utvrdio da Šri Lanka, Trinidad i Tobago i Tunis imaju strateške nedostatke u režimu SPNFT-a koji predstavljaju opasnost za međunarodni financijski sustav, a te su zemlje s FATF-om utvrdile akcijski plan za te nedostatke.
However, these countries have provided a written high-level political commitment to address the identified deficiencies and have developed an action plan with FATF, which would allow the requirements laid down in Directive (EU) 2015/849 to be met.
Uzimajući u obzir visoku razinu integriranosti međunarodnog financijskog sustava, veliku povezanost tržišnih subjekata, velik broj prekograničnih transakcija iz Unije ili prema Uniji, kao i stupanj otvorenosti tržišta, Komisija smatra da je svaka prijetnja za međunarodni financijski sustav, povezana sa suzbijanjem pranja novca i financiranja terorizma, ujedno i prijetnja za financijski sustav Unije.
The Commission will reassess these countries' status in the light of the implementation of the above commitment.
Prema najnovijim relevantnim podacima Komisija je u analizi zaključila da bi Šri Lanku, Trinidad i Tobago i Tunis trebalo smatrati jurisdikcijama trećih zemalja sa strateškim nedostacima u svojem režimu SPNFT-a koji predstavljaju znatnu prijetnju financijskom sustavu Unije u skladu s kriterijima iz članka 9.
Delegated Regulation (EU) 2016/1675 should therefore be amended accordingly,
Direktive (EU) 2015/849.
HAS ADOPTED THIS REGULATION:
Međutim, te su zemlje u pisanom obliku iskazale visoku razinu političke predanosti za uklanjanje utvrđenih nedostataka te su s FATF-om utvrdile akcijski plan, čime se omogućuje ispunjenje zahtjeva utvrđenih u Direktivi (EU) 2015/849.
Article 1
Komisija će ponovno procijeniti status tih zemalja s obzirom na provedbu prethodno navedene predanosti.
In the Annex to Delegated Regulation (EU) 2016/1675, in the table in point I the following lines are inserted:
Delegiranu uredbu (EU) 2016/1675 trebalo bi stoga na odgovarajući način izmijeniti,
Sri Lanka
DONIJELA JE OVU UREDBU:
Trinidad and Tobago
Članak 1.
Tunisia’
U Prilogu Delegiranoj uredbi (EU) 2016/1675 u tablici u točki I. umeću se sljedeći redci:
Article 2
Šri Lanka
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Trinidad i Tobago
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Tunis”
Done at Brussels, 13 December 2017.
Članak 2.
OJ L 141, 5.6.2015, p.
Sastavljeno u Bruxellesu 13. prosinca 2017.
on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials
o uporabi bisfenola A u lakovima i premazima koji dolaze u dodir s hranom i o izmjeni Uredbe (EU) br.
(Text with EEA relevance)
10/2011 u pogledu uporabe te tvari u plastičnim materijalima koji dolaze u dodir s hranom
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC, and in particular points (d), (e), (h), (i) and (j) of Article 5(1) thereof,
uzimajući u obzir Ugovor o funkcioniranju Europske unije,
The substance 2,2-bis(4-hydroxyphenyl)propane (CAS 0000080-05-7), commonly known as bisphenol A (BPA) is used in the manufacture of certain materials and articles intended to come into contact with food, such as polycarbonate plastic and epoxy resins used in varnishes and coatings.
1935/2004 Europskog parlamenta i Vijeća od 27. listopada 2004. o materijalima i predmetima koji dolaze u dodir s hranom i stavljanju izvan snage direktiva 80/590/EEZ i 89/109/EEZ, a posebno njezin članak 5. stavak 1. točke (d), (e), (h), (i) i (j),
BPA can migrate into food from the material or article with which it is in contact, resulting in exposure to BPA for consumers of those foods.
budući da:
The use of BPA as a monomer in the production of plastic materials and articles is authorised by Commission Regulation (EU) No 10/2011.
Tvar 2,2-bis(4-hidroksifenil)propan (CAS 0000080-05-7), poznata kao bisfenol A („BPA”) upotrebljava se u proizvodnji određenih materijala i predmeta koji dolaze u dodir s hranom, kao što su polikarbonatna plastika i epoksidne smole koje se upotrebljavaju u lakovima i premazima.
The authorisation is subject to a specific migration limit (SML) of 0,6 mg of BPA per kg of food (mg/kg) based on a previous evaluation by the Scientific Committee on Food.
BPA može migrirati u hranu iz materijala ili predmeta s kojim hrana dolazi u dodir, što dovodi do izlaganja potrošača te hrane BPA-u.
The European Food Safety Authority (the Authority) has reviewed scientific information and updated its opinion on BPA in 2006, 2008, 2010 and 2011.
Uporaba BPA-a kao monomera u proizvodnji plastičnih materijala i predmeta odobrena je Uredbom Komisije (EU) br.
A prohibition is in place on its use in the manufacture of polycarbonate infant feeding bottles on the basis of the precautionary principle.
10/2011.
After the publication of its scientific advice on BPA in 2011, the Authority noted that its exposure assessment which dated back to its 2006 opinion needed to be updated in light of new data and that the relevance of dietary exposure in the context of other routes of exposure should also be investigated.
Odobrenje podliježe granici specifične migracije (SML) od 0,6 mg BPA-a po kilogramu hrane (mg/kg) na temelju prethodne procjene Znanstvenog odbora za hranu.
The Authority decided to undertake a full re-evaluation of BPA based on the most recent scientific evidence.
Europska agencija za sigurnost hrane („Agencija”) preispitala je znanstvene informacije i ažurirala svoje mišljenje o BPA-u iz 2006., 2008., 2010. i 2011..
In 2012, in accordance with Article 29(1)(b) of Regulation (EC) No 178/2002 of the European Parliament and of the Council, the Authority asked its scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) to provide a scientific opinion on the risks to public health related to the presence of BPA in foodstuffs.
Na snazi je zabrana uporabe BPA-a u proizvodnji polikarbonatnih bočica za hranjenje dojenčadi na temelju načela predostrožnosti.
The Authority adopted an opinion on 11 December 2014, having reviewed the available data and scientific studies published from 2006 to 2012 as well as some studies available in 2013.
Nakon objave znanstvenog mišljenja o BPA-u za 2011.
In that opinion, the Authority established changes in mean relative kidney weight in a two-generation study in mice as the critical endpoint and calculated a Benchmark Dose (Lower Confidence Limit) (BMDL10) of 8960 μg/kg bw per day.
Agencija je istakla da je njezinu procjenu izloženosti, koja potječe iz njezina mišljenju iz 2006., potrebno ažurirati s obzirom na nove podatke te da je potrebno ispitati i relevantnost izlaganja putem hrane u kontekstu drugih načina izlaganja.
It was able to apply new toxicokinetic data to allow a more accurate substance-specific extrapolation of data from animals to humans and established a human equivalent dose (HED) of 609 μg/kg bw per day.
Agencija je odlučila provesti potpunu ponovnu procjenu BPA-a na temelju najnovijih znanstvenih dokaza.
The HED was used as a reference point for establishing a health-based guidance value for BPA.
Agencija je 2012. u skladu s člankom 29. stavkom 1. točkom (b) Uredbe (EZ) br.
To establish this health-based guidance value, the Authority applied an uncertainty factor of 2,5 for inter-species differences and 10 for intra-species differences.
178/2002 Europskog parlamenta i Vijeća zatražila znanstveno mišljenje svojeg Znanstvenog odbora za materijale koji dolaze u dodir s hranom, enzime, arome i pomoćne tvari u procesu proizvodnje (CEF) o rizicima za javno zdravlje povezanima s prisutnošću BPA-a u hrani.
It applied an additional factor of 6 to take into account uncertainties surrounding potential health effects of BPA on the mammary gland, reproductive, metabolic, neurobehavioural and immune systems.
Agencija je 11. prosinca 2014. donijela mišljenje nakon preispitivanja dostupnih podataka i znanstvenih studija objavljenih u razdoblju od 2006. do 2012. te neke studije dostupne u 2013.
As a result, an overall uncertainty factor of 150 was applied to establish a new Tolerable Daily Intake (TDI) of 4 μg/kg bw per day.
Agencija je u tom mišljenju promjene u prosječnoj relativnoj masi bubrega u studiji kojom su obuhvaćene dvije generacije miševa utvrdila kao kritične krajnje učinke te je izračunala referentnu vrijednost (statistička donja granica pouzdanosti) (BMDL10) od 8960 μg/kg tjelesne mase na dan.
However, the Authority designated the TDI as temporary (t-TDI) pending the anticipated outcome of a long-term toxicity study on BPA in rodents being undertaken by the National Toxicology Program/Food and Drug Administration (NTP/FDA) in the United States of America (USA).
Mogla je primijeniti nove toksikokinetičke podatke kako bi se omogućila točnija ekstrapolacija podataka za određenu tvar sa životinja na ljude te je utvrdila ekvivalentnu dozu za ljude (HED) od 609 μg/kg tjelesne težine na dan.
The Authority noted that dietary exposure to BPA is below the t-TDI and concluded that there is no health concern at the estimated levels of exposure.
HED je poslužio kao referentna točka za utvrđivanje orijentacijske vrijednosti za BPA koja se temelji na utjecaju na zdravlje.
In its opinion adopted on 11 December 2014, the Authority also estimated non-dietary sources of exposure as well as those from the diet.
Pri utvrđivanju orijentacijske vrijednosti koja se temelji na utjecaju na zdravlje Agencija je primijenila faktor nesigurnosti 2,5 za razlike među vrstama i 10 za razlike unutar vrste.
Non-dietary sources include exposure through air, ingestion of dust and uptake through the skin as a result of contact with thermal paper and cosmetics.
Primijenila je dodatni faktor 6 kako bi se u obzir uzele nesigurnosti povezane s mogućim utjecajem BPA-a na zdravlje mliječne žlijezde, reproduktivnog, metaboličkog, neurobihejvioralnog i imunološkog sustava.
The Panel concluded that the central estimates for aggregated exposure to BPA through dietary and non-dietary sources for the highest exposed groups including infants, children and adolescents, are below the t-TDI and that the health concern for BPA is low at the estimated levels of aggregated exposure.
Kao rezultat toga primijenjen je opći faktor nesigurnosti 150 pri utvrđivanju novog prihvatljivog dnevnog unosa (TDI) od 4 μg/kg tjelesne težine na dan.
Following the opinion published by the Authority in 2014, the current SML for plastic materials and articles should be updated to take account of the new t-TDI.
Međutim, Agencija je utvrdila TDI kao privremenu vrijednost (t-TDI) u očekivanju predviđenog rezultata dugoročne studije toksičnosti BPA-a na glodavcima koja se provodi u okviru nacionalnog programa toksikologije Uprave za hranu i lijekove (NTP/FDA) u Sjedinjenim Američkim Državama (SAD).
The setting of the SML uses a conventional exposure assumption that 1 kg of food is consumed daily by a person of 60 kg body weight and that all exposure comes from food contact materials.
Agencija je napomenula da je izloženost BPA-u putem hrane ispod vrijednosti t-TDI-ja te zaključila da na procijenjenim razinama izloženosti ne postoji opasnost za zdravlje.
Article 5(1)(e) of Regulation (EC) No 1935/2004 establishes that specific limits on the migration of certain constituents into or onto food should take due account of other possible sources of exposure to those constituents.
U svojemu mišljenju donesenom 11. prosinca 2014.
The Authority noted that exposure from non-dietary sources of BPA may contribute a significant proportion of overall exposure for some population groups and that in addition to these non-dietary sources, non-canned meat and meat products were found to be a major contributor to BPA exposure for several population groups.
Agencija je uz prehrambene procijenila i neprehrambene izvore izlaganja.
In such cases where sources other than food contact materials may contribute significantly to the potential overall exposure of a substance, it is not appropriate to allocate the full TDI to food contact materials and a lower value should be used.
Neprehrambeni izvori obuhvaćaju izlaganje preko zraka, gutanje prašine i unos preko kože kao posljedica dodira s termalnim papirom i kozmetikom.
Taking into account conventional assumptions on the use of allocation factors for food contact materials, including that the overall exposure does not exceed the t-TDI and the uncertainty factor of 150 in the derivation of the t-TDI, as well as the data in the Authority's opinion on sources of BPA other than food contact materials, an allocation factor of 20 % is considered appropriate when setting the SML.
Odbor je zaključio da su središnje procjene ukupne izloženosti BPA-u iz prehrambenih i neprehrambenih izvora za najizloženije skupine, uključujući dojenčad, djecu i mlade, ispod vrijednosti t-TDI-ja te da je na procijenjenim razinama ukupne izloženosti opasnost za zdravlje u pogledu BPA-a mala.
Therefore, on the basis of the t-TDI, the allocation factor and the exposure assumption, an SML of 0,05 mg of BPA per kg of food (mg/kg) should be set for plastic materials and articles to ensure that exposure to BPA remains below the t-TDI and does not endanger human health.
Nakon mišljenja koje je objavila Agencija u 2014. trebalo bi ažurirati postojeći SML za plastične materijale i predmete kako bi se uzeo u obzir novi t-TDI.
While the SML established, which takes into account the opinion, serves as a basis for the overall management of risks posed by BPA from food contact materials, there are still uncertainties, which are identified in that opinion.
Pri utvrđivanju SML-a primjenjuje se standardna pretpostavka o izloženosti da osoba od 60 kg tjelesne mase dnevno konzumira 1 kg hrane te da sva izloženost potječe iz materijala koji dolaze u dodir s hranom.
With respect to two new studies on the developmental immunotoxicity of BPA, the Authority stated in 2016 that the new evidence presented by those studies adds to the indications of developmental immunotoxicity of BPA.
Člankom 5. stavkom 1. točkom (e) Uredbe (EZ) br.
Taking into account the extent of the scientific uncertainties and the nature of the potential adverse effects, in particular developmental effects, further precautionary steps should be taken as regards more vulnerable population groups, in particular infants and young children, where developmental effects could be irreversible and would last a life-time.
1935/2004 utvrđeno je da bi pri utvrđivanju posebnih ograničenja migracije određenih sastojaka u ili na hranu trebalo uzeti u obzir druge moguće izvore izlaganja tim sastojcima.
The precautionary principle referred to in Article 7 of Regulation (EC) No 178/2002 authorises the adoption of provisional measures on the basis of available pertinent information, pending results related to continued uncertainties, to an additional assessment of risk and a review of the measure within a reasonable period of time.
Agencija je napomenula da izloženost BPA-u iz neprehrambenih izvora može imati znatan udio u ukupnoj izloženosti za određene skupine stanovništva i da se, osim tih neprehrambenih izvora, za nekonzervirano meso i mesne proizvode utvrdilo da su glavni izvor izlaganja BPA-u za određene skupine stanovništva.
The Commission is authorised to take preventive measures as regards the use of BPA on the basis of the precautionary principle which is applicable in a situation in which there is scientific uncertainty, even if the risk, notably to human health, has not yet been fully demonstrated.
U slučajevima kada mogućoj ukupnoj izloženosti određenoj tvari mogu znatno pridonijeti drugi izvori, osim materijala koji dolaze u dodir s hranom, za te materijale nije primjereno primijeniti punu, već smanjenu vrijednost TDI-ja.
In order to do so, BPA should not be used to manufacture polycarbonate drinking cups or bottles which are intended for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council.
Uzimajući u obzir standardne pretpostavke o uporabi faktora dodjeljivanja za materijale koji dolaze u dodir s hranom, uključujući pretpostavku da ukupna izloženost nije veća od t-TDI-ja i da faktor nesigurnosti pri utvrđivanju t-TDI-ja iznosi 150, te podatke iz mišljenja Agencije o drugim izvorima BPA-a, osim materijala koji dolaze u kontakt s hranom, pri utvrđivanju SML-a primjereno je primijeniti faktor dodjeljivanja od 20 %.
In addition to its use in plastic food contact materials, BPA is used extensively in epoxy resins for varnishes and coatings, particularly for application on the interior of food cans.
Stoga je na temelju t-TDI-ja, faktora dodjeljivanja i pretpostavki o izloženosti, potrebno utvrditi SML od 0,05 mg BPA-a po kilogramu hrane (mg/kg) za plastične materijale i predmete kako bi se osiguralo da BPA ostane ispod t-TDI-ja i da ne ugrožava zdravlje ljudi.
While specific measures provided for in Article 5 of Regulation (EC) No 1935/2004 have been adopted as regards BPA in plastic materials and articles, such measures have not been adopted as regards BPA in varnishes and coatings at the Union level.
Iako utvrđeni SML, u kojem se uzima u obzir mišljenje, služi kao osnova za sveukupno upravljanje rizicima koje predstavlja BPA iz materijala koji dolaze u dodir s hranom, još uvijek postoje nesigurnosti koje su utvrđene u tom mišljenju.
Therefore, in accordance with Article 6 of that Regulation, Member States have been able to maintain or adopt national provisions on BPA in varnishes and coatings provided those measures comply with the rules laid down in the Treaties.
S obzirom na dvije nove studije o razvojnoj imunotoksičnosti BPA-a, Agencija je 2016. navela da novi dokazi iz tih studija dodatno upućuju na razvojnu imunotoksičnost BPA-a.
In light of the introduction by Member States of divergent national measures applicable to BPA in food contact materials and the resulting technical and practical burdens reported by industry, and having regard to the contribution to dietary exposure of BPA from canned food identified in the Authority's opinion of 2014 and the extensive use of BPA in epoxy resins for varnishes and coatings applied to food cans, it is also appropriate to establish restrictions for BPA used in varnishes and coatings.
Uzimajući u obzir znanstvene nesigurnosti i prirodu potencijalnih negativnih učinaka, osobito učinke na razvoj, treba poduzeti daljnje mjere opreza u pogledu ranjivih skupina stanovništva, posebno dojenčadi i male djece, kod kojih učinci na razvoj mogu biti nepovratni i mogu trajati cijeli život.
The same assumption concerning exposure to BPA from plastic materials and articles applies to varnishes and coatings.
Načelom predostrožnosti iz članka 7.
In order to ensure the effective functioning of the internal market and to ensure a high level of protection for human health, the SML established for BPA from plastic materials and articles should also apply to varnishes and coatings applied to materials and articles, where that varnish or coating has been produced using BPA.
Uredbe (EZ) br.
As BPA may be used in food packaging containing foods for infants and young children, BPA should not migrate from varnishes and coatings applied to materials or articles specifically intended to come into contact with food intended for infants and young children as referred to in Regulation (EU) No 609/2013, namely infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children.
178/2002 dopušta se donošenje privremenih mjera na temelju dostupnih odgovarajućih informacija, u očekivanju rezultata, povezanih s trajnim nesigurnostima, dodatne procjene rizika i preispitivanja mjera u razumnom vremenskom roku.