natgillin/translations-raw huggingface dataset:
According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2014.
Prema informacijama koje je primila Komisija, za ulove stoka iz Priloga ovoj Uredbi ostvarene plovilima koja plove pod zastavom države članice iz tog Priloga ili koja su registrirana u toj državi članici iscrpljena je kvota dodijeljena za 2014.
Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex.
Aktivnosti ribolova za stok iz Priloga ovoj Uredbi za plovila koja plove pod zastavom države članice iz tog Priloga ili koja su registrirana u toj državi članici zabranjuju se od datuma utvrđenog u tom Prilogu.
VIIb-k, VIII, IX and X; Union waters of CECAF 34.1.1
b-k, VIII., IX. i X. te vode Unije u zoni CECAF 34.1.1
Commission Regulation (EU) No 1135/2014
Uredba Komisije (EU) br. 1135/2014
on the authorisation of a health claim made on foods and referring to the reduction of disease risk
o odobravanju zdravstvene tvrdnje koja se navodi na hrani, a odnosi se na smanjenje rizika od bolesti
Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.
U skladu s Uredbom (EZ) br. 1924/2006 zdravstvene tvrdnje koje se navode na hrani zabranjene su osim ako ih je odobrila Komisija u skladu s tom Uredbom i ako su uvrštene na popis dopuštenih tvrdnji.
Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State.
Uredbom (EZ) br. 1924/2006 predviđa se da subjekti u poslovanju s hranom mogu podnositi zahtjeve za odobravanje zdravstvenih tvrdnji nadležnom nacionalnom tijelu države članice.
The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.
Komisija odlučuje o odobravanju zdravstvenih tvrdnji uzimajući u obzir mišljenje koje je donijela Agencija.
Following an application from Rank Nutrition Ltd, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was asked to deliver an opinion on a health claim related to ‘Increasing maternal folate status by supplemental folate intake and reduced risk of neural tube defects.’ (Question No EFSA-Q-2013-00265) [2].
Na temelju zahtjeva trgovačkog društva Rank Nutrition Ltd podnesenog u skladu s člankom 14. stavkom 1. točkom (a) Uredbe (EZ) br. 1924/2006 zatraženo je mišljenje Agencije o zdravstvenoj tvrdnji koja se odnosi na „povećavanje statusa folata majke dodatnim unosom folata i smanjeni rizik od oštećenja neuralne cijevi” (pitanje br. EFSA-Q-2013-00265) [2].
The claim proposed by the applicant was worded as follows:
Tvrdnja koju je predložio podnositelj zahtjeva glasila je kako slijedi:
‘Folic acid supplementation raises maternal red blood cell folate. Low maternal red blood cell folate is a risk factor for neural tube defects in the developing foetus’.
„Dodatnim unosom folne kiseline povećava se razina folata u crvenim krvnim stanicama majke. Niska razina folata u crvenim krvnim stanicama majke rizični je faktor za oštećenja neuralne cijevi fetusa u razvoju”.
On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 26 July 2013 that a cause and effect relationship had been established between increasing maternal folate status by supplemental folate intake and a reduced risk of neural tube defects (NTDs).
Na temelju iznesenih podataka Agencija je u svojem mišljenju, koje su Komisija i države članice primile 26. srpnja 2013., zaključila da postoji uzročno-posljedična veza između povećanja razine folata majke dodatnim unosom folata i smanjenog rizika od oštećenja neuralne cijevi (NTD).
Accordingly, a health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and should be included in the Union list of permitted claims.
Stoga zdravstvenu tvrdnju u kojoj se taj zaključak odražava treba smatrati sukladnom zahtjevima Uredbe (EZ) br. 1924/2006 te je treba uvrstiti na popis dopuštenih tvrdnji Unije.
Article 16(4) of Regulation (EC) No 1924/2006 provides that an opinion in favour of authorising a health claim is to include certain particulars.
Člankom 16. stavkom 4. Uredbe (EZ) br. 1924/2006 propisano je da mišljenje u korist odobrenja zdravstvene tvrdnje mora sadržavati određene podatke.
Accordingly, those particulars should be set out in the Annex to this Regulation as regards the authorised claim and include, as the case may be, the revised wording of the claim, specific conditions of use of the claim, and, where applicable, conditions or restrictions of use of the food and/or an additional statement or warning, in accordance with the rules laid down in Regulation (EC) No 1924/2006 and in line with the opinion of the Authority.
U skladu s tim, ti se podaci trebaju navesti u Prilogu ovoj Uredbi u pogledu odobrene tvrdnje i uključivati, ovisno o slučaju, revidirani tekst tvrdnje, posebne uvjete njezine uporabe te, ako je primjenjivo, uvjete ili ograničenja uporabe hrane i/ili dodatnu izjavu ili upozorenje, u skladu s pravilima utvrđenima u Uredbi (EZ) br. 1924/2006 i u skladu s mišljenjem Agencije.
One of the objectives of Regulation (EC) No 1924/2006 is to ensure that health claims are truthful, clear and reliable and useful to the consumer, and that wording and presentation are taken into account in that respect.
Jedan od ciljeva Uredbe (EZ) br. 1924/2006 jest osigurati da zdravstvene tvrdnje budu istinite, jasne, pouzdane i korisne potrošaču te da se u tom smislu uzme u obzir tekst i prikaz tih tvrdnji.
Therefore where the wording of claims has the same meaning for consumers as that of an authorised health claim, because they demonstrate the same relationship that exists between a food category, a food or one of its constituents and health, they should be subject to the same conditions of use indicated in the Annex to this Regulation.
Stoga, ako tekst određene tvrdnje za potrošače ima isto značenje kao i tekst neke dopuštene zdravstvene tvrdnje jer upućuje na istu vezu između zdravlja i određene kategorije hrane, određene hrane ili njezina sastojka, potrebno je da se na tu tvrdnju primjenjuju isti uvjeti uporabe kao oni navedeni u Prilogu ovoj Uredbi.
The health claim listed in the Annex to this Regulation may be made on foods placed on the Union market in compliance with the conditions laid down in that Annex.
Zdravstvena tvrdnja navedena u Prilogu ovoj Uredbi može se navoditi na hrani koja se stavlja na tržište Unije u skladu s uvjetima utvrđenima u tom Prilogu.
The health claim referred to in paragraph 1 shall be included in the Union list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006.
Zdravstvena tvrdnja iz stavka 1. uvrštava se na popis dopuštenih tvrdnji Unije kako je predviđeno člankom 14. stavkom 1. Uredbe (EZ) br. 1924/2006.
PERMITTED HEALTH CLAIM
ODOBRENA ZDRAVSTVENA TVRDNJA
Application — Relevant provisions of Regulation (EC) No 1924/2006
Zahtjev – relevantne odredbe Uredbe (EZ) br. 1924/2006
Applicant — Address
Podnositelj zahtjeva – adresa
Article 14(1)(a) health claim referring to a reduction of a disease risk
Članak 14. stavak 1. točka (a) – zdravstvena tvrdnja koja se odnosi na smanjenje rizika od bolesti
Rank Nutrition Ltd, Long Barn, Etchden Court, Bethersden, Kent, TN26 3DP, United Kingdom .
Rank Nutrition Ltd, Long Barn, Etchden Court, Bethersden, Kent TN26 3DP, Ujedinjena Kraljevina
Supplemental folic acid intake increases maternal folate status.
Dodatnim unosom folne kiseline povećava se razina folata majke.
Low maternal folate status is a risk factor in the development of neural tube defects in the developing foetus.
Niska razina folata majke rizičan je faktor za razvoj oštećenja neuralne cijevi kod fetusa u razvoju.
The claim may be used only for food supplements which provide at least 400 μg of folic acid per daily portion.
Tvrdnja se može upotrijebiti samo za dodatke prehrani s dnevnom dozom od najmanje 400 μg folne kiseline.
Information shall be provided to the consumer that the target population is women of child-bearing age and the beneficial effect is obtained with a supplemental folic acid daily intake of 400 μg for at least one month before and up to three months after conception.
Potrošačima je potrebno pružiti informaciju da su ciljana skupina žene u reproduktivnoj dobi te da se koristan učinak postiže dodatnim dnevnim unosom od najmanje 400 μg folne kiseline tijekom najmanje jednog mjeseca prije i tri mjeseca nakon začeća.
Commission Regulation (EU) No 1136/2014
Uredba Komisije (EU) br. 1136/2014
amending Regulation (EU) No 283/2013 as regards the transitional measures applying to procedures concerning plant protection products
o izmjeni Uredbe (EU) br. 283/2013 u pogledu prijelaznih mjera u vezi s postupcima koji se odnose na sredstva za zaštitu bilja
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC [1], and in particular Article 78(1)(b) thereof,
uzimajući u obzir Uredbu (EZ) br. 1107/2009 Europskog parlamenta i Vijeća od 21. listopada 2009. o stavljanju na tržište sredstava za zaštitu bilja i stavljanju izvan snage direktiva Vijeća 79/117/EEZ i 91/414/EEZ [1], a posebno njezin članak 78. stavak 1. točku (b),
Commission Regulation (EU) No 283/2013 [2] repealed Commission Regulation (EU) No 544/2011 [3] and laid down new data requirements for active substances.
Uredbom Komisije (EU) br. 283/2013 [2] stavljena je izvan snage Uredba Komisije (EU) br. 544/2011 [3] te su utvrđeni novi zahtjevi u pogledu podataka o aktivnim tvarima.
In order to permit Member States and the interested parties to prepare themselves to meet those new requirements, Regulation (EU) No 283/2013 sets transitional measures concerning both submission of data for applications for the approval, renewal of approval or amendment to the approval of active substances and submission of data for applications for authorisation, renewal of authorisation or amendment to the authorisation of plant protection products.
Kako bi se državama članicama i zainteresiranim stranama omogućilo da se pripreme za ispunjavanje tih novih zahtjeva, Uredbom (EU) br. 283/2013 utvrđene su prijelazne mjere povezane s dostavljanjem podataka za zahtjeve za odobrenje, produljenje odobrenja ili izmjenu odobrenja aktivnih tvari, ali i s dostavljanjem podataka za zahtjeve za registraciju, produljenje registracije ili izmjenu registracije sredstava za zaštitu bilja.
In order to allow, in certain cases, the submission of data concerning the active substances in applications for authorisation or for amendment of the authorisation of plant protection products in accordance with the data requirements in force at the time of their approval or renewal, the transitional measures as regards procedures concerning the authorisation of plant protection products should be amended.
Kako bi se u određenim slučajevima omogućilo dostavljanje podataka o aktivnim tvarima u zahtjevima za registraciju ili zahtjevima za izmjenu registracije sredstava za zaštitu bilja u skladu sa zahtjevima u pogledu podataka o aktivnim tvarima koji su bili na snazi u vrijeme njihova odobrenja ili produljenja, trebalo bi izmijeniti prijelazne mjere u pogledu postupaka koji se odnose na registraciju sredstava za zaštitu bilja.
The reason for such change is to prevent the occurrence of disparities in the assessment of data generated in accordance with the new data requirements by Member States belonging to different zones and, accordingly, to preserve a uniform and harmonized approach to the assessment of those data through their evaluation at Union level.
Razlog te promjene jest sprečavanje pojave da države članice koje pripadaju različitim zonama neusklađeno ocjenjuju podatke dobivene u skladu s novim zahtjevima u pogledu podataka te, u skladu s time, očuvanje jedinstvenog i usklađenog pristupa ocjeni tih podataka putem njihove evaluacije na razini Unije.
Article 4(1) of Regulation (EU) No 283/2013 is replaced by the following:
Članak 4. stavak 1. Uredbe (EZ) br. 283/2013 zamjenjuje se sljedećim:
Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1).
Uredba Komisije (EU) br. 283/2013 od 1. ožujka 2013. o utvrđivanju zahtjeva u pogledu podataka o aktivnim tvarima, u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja (SL L 93, 3.4.2013., str. 1.).
Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (OJ L 155, 11.6.2011, p. 1).
Uredba Komisije (EU) br. 544/2011 od 10. lipnja 2011. o provedbi Uredbe (EZ) br. 1107/2009 Europskog parlamenta i Vijeća u pogledu zahtjeva za podacima za aktivne tvari (SL L 155, 11.6.2011., str. 1.).
Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).’
Provedbena uredba Komisije (EU) br. 844/2012 od 18. rujna 2012. o određivanju odredaba potrebnih za provedbu postupka obnavljanja odobrenja za aktivne tvari, kako je predviđeno Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja (SL L 252, 19.9.2012., str. 26.).”
In case of applications for authorisation, as referred to in Article 28 of Regulation (EC) No 1107/2009, which concern plant protection products containing one or more active substances for which the dossiers have been submitted in compliance with Article 3 or for which the approval has not been renewed in accordance with Article 14 of Regulation (EC) No 1107/2009 and in accordance with Commission Implementing Regulation (EU) No 844/2012, Regulation (EU) No 544/2011 shall continue to apply to the submission of data concerning this(these) active substance(s). .
U slučaju zahtjevâ za registraciju, kako je navedeno u članku 28. Uredbe (EZ) br. 1107/2009, koji se odnose na sredstva za zaštitu bilja koja sadržavaju jednu ili više aktivnih tvari za koje je dokumentacija dostavljena u skladu s člankom 3. ili za koje odobrenje nije produljeno u skladu s člankom 14. Uredbe (EZ) br. 1107/2009 i u skladu s Provedbenom uredbom Komisije (EU) br. 844/2012, na dostavljanje podataka o toj aktivnoj tvari ili tim aktivnim tvarima i dalje se primjenjuje Uredba (EU) br. 544/2011.
Commission Regulation (EU) No 1137/2014
Uredba Komisije (EU) br. 1137/2014
of 27 October 2014
оd 27. listopada 2014.
amending Annex III of Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards the handling of certain offal from animals intended for human consumption
o izmjeni Priloga III. Uredbe (EZ) br. 853/2004 Europskog parlamenta i Vijeća u pogledu obrade određenih nusproizvoda klanja životinja koji su namijenjeni prehrani ljudi
That Regulation provides that food business operators are to ensure compliance with specific requirements for the further handling of offal such as stomachs of ruminants and feet of ungulates.
Tom se Uredbom predviđa da subjekti u poslovanju s hranom moraju osigurati sukladnost s posebnim uvjetima za daljnju obradu nusproizvoda klanja poput želudaca preživača i nogu papkara i kopitara.
In accordance with Annex III to that Regulation, prior to being transported to another establishment, feet of ungulates destined for further handling are to be skinned or scalded and depilated and stomachs of ruminants must be scalded or cleaned within the slaughterhouse.
U skladu s Prilogom III. toj Uredbi, prije prijevoza u drugi objekt, s nogu papkara i kopitara predviđenih za daljnju obradu mora se skinuti koža ili ih se mora ošuriti i ukloniti im se dlake, a želuci preživača moraju se ošuriti ili očistiti unutar klaonice.
The equipment necessary to perform the skinning or scalding and depilating requires a high investment.
Oprema potrebna za uklanjanje kože ili šurenje i uklanjanje dlaka iziskuje visoka ulaganja.
Therefore, small and medium-size slaughterhouses in particular are not able to handle feet destined for human consumption themselves in a cost-effective way.
Zato posebno male i srednje klaonice ne mogu na troškovno učinkovit način obrađivati noge namijenjene prehrani ljudi.
While technological developments allow the valorisation of feet of ungulates into food thereby reducing food waste, in particular small and medium-size slaughterhouses are facing practical consequences, hindering such valorisation.
Iako se tehnološkim razvojem omogućuje iskorištavanje nogu papkara i kopitara u svrhu prehrane, čime se smanjuje otpad od hrane, posebno se male i srednje klaonice suočavaju s praktičnim posljedicama koje onemogućuju takvo iskorištavanje.
Rennet is refined for the production of cheese and is obtained from stomachs of young ruminants in dedicated establishments.
Sirilo koje se rafinira za proizvodnju sira dobiva se od želudaca mladih preživača u specijaliziranim objektima.
Scalding or cleaning of stomachs substantially reduces the yield of rennet from these stomachs while it does not contribute to the safety of the rennet, being highly refined afterwards.
Šurenje ili čišćenje želudaca znatno smanjuje količinu sirila dobivenog iz tih želudaca i ne pridonosi sigurnosti sirila budući da se ono kasnije obrađuje postupkom visokog rafiniranja.
To promote better regulation and competitiveness a high level of food safety must be maintained, while offering a level-playing field for operators, which is also sustainable for small and medium-size slaughterhouses.
U cilju boljeg uređenja i konkurentnosti potrebno je održati visoku razinu sigurnosti hrane, istodobno osiguravajući jednake uvjete tržišnog natjecanja za subjekte, koje su isto tako održivi za male i srednje klaonice.
Stomachs of ruminants and feet of ungulates are included in the definition of offal in Annex I to Regulation (EC) No 853/2004.
Želuci preživača i noge papkara i kopitara obuhvaćeni su definicijom nusproizvoda klanja u Prilogu I. Uredbi (EZ) br. 853/2004.
The requirements for handling of offal in that Regulation, including the temperature requirements during storage and transport, ensure that these products can be safely handled and transported to an establishment outside the slaughterhouse, collected from different slaughterhouses and valorised.
Uvjetima za obradu nusproizvoda klanja u toj Uredbi, uključujući uvjete temperature tijekom skladištenja i prijevoza, osigurava se da se tim proizvodima rukuje i da se oni prevoze na siguran način u objekt izvan klaonice, prikupljaju iz različitih klaonica i iskorištavaju.
The transport to another establishment of non-skinned or non-scalded and non-depilated feet of ungulates should therefore be allowed by the competent authority.
Stoga bi nadležno tijelo trebalo odobriti prijevoz u drugi objekt nogu papkara i kopitara kojima nije skinuta koža ili koje se nisu ošurile i kojima nisu uklonjene dlake.
In Annex III to Regulation (EC) No 853/2004, point 18 of Chapter IV of Section I is replaced by the following:
U Prilogu III. odjeljku I. poglavlju IV. Uredbe (EZ) br. 853/2004 točka 18. zamjenjuje se sljedećom:
When destined for further handling:
Ako su predviđeni za daljnju obradu:
intestines must be emptied and cleaned;
crijeva se moraju isprazniti i očistiti;
Done at Brussels, 27 October 2014.
Sastavljeno u Bruxellesu 27. listopada 2014.
stomachs must be scalded or cleaned; however, in the case of stomachs of young ruminants intended for rennet production, the stomachs need only be emptied;
želuci se moraju ošuriti i očistiti, međutim u slučaju želudaca mladih preživača namijenjenih proizvodnji sirila želuci se moraju samo isprazniti;
heads and feet must be skinned or scalded and depilated; however, when authorised by the competent authority, visibly clean feet may be transported to and skinned or scalded and depilated in an approved establishment further handling the feet for processing into food.’ .
s glava i nogu mora se skinuti koža ili ih se mora ošuriti i ukloniti im se dlake, međutim uz dozvolu nadležnog tijela vidljivo čiste noge mogu se prevesti i koža im se može skinuti ili ih se može ošuriti i ukloniti im se dlake u ovlaštenom objektu u kojemu se noge dalje obrađuju za preradu u hranu.”
Commission Implementing Regulation (EU) No 1138/2014
Provedbena uredba Komisije (EU) br. 1138/2014
concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 as a feed additive for sows (holder of the authorisation Adisseo France S.A.S.)
o odobrenju pripravka endo-1,4-beta-ksilanaze i endo-1,3(4)-beta-glukanaze dobivenog od Talaromyces versatilis sp. nov. IMI CC 378536 kao dodatka hrani za krmače (nositelj odobrenja Adisseo France S.A.S.)
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536.
U skladu s člankom 7. Uredbe (EZ) br. 1831/2003 podnesen je zahtjev za odobrenje pripravka endo-1,4-beta-ksilanaze i endo-1,3(4)-beta-glukanaze dobivenog od Talaromyces versatilis sp. nov. IMI CC 378536.
That application concerns the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 as a feed additive for sows to be classified in the additive category ‘zootechnical additives’.
Zahtjev se odnosi na odobrenje pripravka endo-1,4-beta-ksilanaze i endo-1,3(4)-beta-glukanaze dobivenog od Talaromyces versatilis sp. nov. IMI CC 378536 kao dodatka hrani za krmače te njegovo razvrstavanje u kategoriju dodataka „zootehnički dodaci”.
A preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 was authorised for 10 years for poultry, weaned piglets and pigs for fattening by Commission Implementing Regulation (EU) No 290/2014 [2].
Pripravak endo-1,4-beta-ksilanaze i endo-1,3(4)-beta-glukanaze dobiven od Talaromyces versatilis sp. nov. IMI CC 378536 odobren je na deset godina za perad, odbijenu prasad i svinje za tov Provedbenom uredbom Komisije (EU) br. 290/2014 [2].
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 May 2014 [3] that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Talaromyces versatilis sp. nov. IMI CC 378536 does not have an adverse effect on animal health, human health or the environment.
Europska agencija za sigurnost hrane (dalje u tekstu: „Agencija”) u svojem je mišljenju od 20. svibnja 2014. [3] zaključila da u predloženim uvjetima uporabe pripravak endo-1,4-beta-ksilanaze EC 3.2.1.8 i endo-1,3(4)-beta-glukanaze EC 3.2.1.6 dobiven od Talaromyces versatilis sp. nov. IMI CC 378536 nema nepovoljan učinak na zdravlje životinja, zdravlje ljudi ili na okoliš.