natgillin/translations-raw huggingface dataset:
glanders has not occurred during the last six months;
ne prihaja z gospodarstva, za katerega je veljala prepoved zaradi zdravja živali, niti ni prišel v stik z enoprstimi kopitarji z gospodarstva, za katerega je veljala prepoved zaradi zdravja živali, ki je zajemala naslednje pogoje:
it does not come from the territory or from a part of the territory of a third country considered, in accordance with Union legislation, as infected with African horse sickness;
če se z gospodarstva ni odstranilo vseh živali vrst, dovzetnih za eno ali več bolezni, navedenih v nadaljnjem besedilu, je prepoved trajala:
it does not come from a holding which was subject to a prohibition order for animal health reasons nor had contact with equidae from a holding which was subject to a prohibition order for animal health reasons which laid down the following conditions:
v primeru encefalomielitisa enoprstih kopitarjev šest mesecev, od dneva zakola ali odstranitve okuženih enoprstih kopitarjev iz prostorov,
if not all animals of species susceptible to one or more of the diseases referred to hereinafter were removed from the holding, the prohibition lasted for:
v primeru infekciozne anemije enoprstih kopitarjev tako dolgo, dokler dva Cogginsova preskusa, ki se opravita na vzorcih preostalih živali po zakolu okuženih živali, nista bila negativna v razmaku treh mesecev,
six months in the case of equine encephalomyelitis, beginning on the date on which the equidae suffering from the disease were slaughtered or removed from the premises,
v primeru stekline en mesec od zadnjega ugotovljenega primera,
a period required to carry out two Coggins tests three months apart giving negative results on samples taken from the animals remaining after infected animals have been slaughtered, in the case of equine infectious anaemia,
v primeru vraničnega prisada 15 dni od zadnjega ugotovljenega primera;
one month from the last recorded case, in the case of rabies,
če so bile vse živali vrst, dovzetnih za bolezni, zaklane ali odstranjene z gospodarstva, traja obdobje prepovedi 30 dni ali v primeru vraničnega prisada 15 dni od dne čiščenja in dezinfekcije prostorov po uničenju ali odstranitvi živali;
15 days from the last recorded case, in the case of anthrax;
prihaja z gospodarstva, ki:
if all the animals of species susceptible to the disease have been slaughtered or removed from the holding, the period of prohibition shall be 30 days, or 15 days in the case of anthrax, beginning on the day on which the premises were cleaned and disinfected following the destruction or removal of the animals;
ni imelo prepovedi zaradi vezikularnega stomatitisa in žival ni bila v stiku z enoprstimi kopitarji z gospodarstva, za katerega je veljala prepoved zadnjih šest mesecev (3); ali
it comes from a holding which:
30 dni pred odpošiljanjem ni bilo okuženo z vezikularnim stomatitisom in na katerem je bila žival v 30 dneh pred odpošiljanjem zaščitena pred vektorskimi insekti ter je bila na njej izvedena ena izmed naslednjih zdravstvenih preiskav na vzorcu krvi, ki je bil odvzet ne prej kot 21 dni po začetku obdobja zaščite pred vektorji:
either was not subject to a prohibition order for vesicular stomatitis and the animal had no contact with equidae from a holding which was subject to such a prohibition order during the past six months (3); or
test nevtralizacije virusa, ki je pokazal negativen rezultat pri razredčini seruma 1 proti 12 (3),
was free of vesicular stomatitis during the 30 days prior to dispatch and on which the animal was protected from vector insects during the 30 days prior to dispatch and where it underwent one of the following health tests carried out on a blood sample taken not earlier than 21 days after the commencement of the vector protection period:
serološki test, ki je pokazal negativen rezultat v skladu s točko B(2) poglavja 2.1.19 Priročnika o diagnostičnih testih in cepivih za kopenske živali Svetovne organizacije za zdravje živali (OIE) (3);
a virus neutralisation test giving a negative result at a serum dilution of 1 in 12 (3),
po moji najboljši vednosti 15 dni pred izdajo tega spričevala ni bil v stiku z enoprstimi kopitarji, obolelimi za kužno ali nalezljivo boleznijo.
a serological test carried out and giving a negative result in accordance with point B(2) of Chapter 2.1.19 of the Manual for Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE) (3);
Podatki o bivanju in karanteni:
to the best of my knowledge, it has not been in contact with equidae suffering from an infectious or contagious disease in the 15 days prior to this Declaration.
Konj je vstopil na ozemlje Mehike (3)/Združenih držav Amerika (3) dne (4).
Residence and quarantine information:
Konj je v Mehiko (3)/Združene države Amerike (3) prispel iz države članice Evropske unije ali iz Mehike (3)/Združenih držav Amerike (3).
The horse entered the territory of Mexico (3)/the United States of America (3) on (4).
Glede na razpoložljive podatke se konj izven Evropske unije ni zadrževal neprekinjeno 30 dni ali več, vključno z dnem načrtovane vrnitve v skladu s tem spričevalom, in od izhoda iz Evropske unije ni bil zunaj Mehike ali Združenih držav Amerike.
The horse arrived in Mexico (3)/the United States of America (3) from a Member State of the European Union or from Mexico (3)/the United States of America (3).
V. Konj bo poslan v vozilu, vnaprej očiščenem in razkuženem z razkužilom, ki je uradno odobreno v tretji državi odpošiljanja, ter oblikovanem tako, da iztrebki, stelja ali krma med prevozom ne morejo padati z vozila.
As far as can be ascertained, the horse has not been continuously outside the European Union for 30 days or more, including the date of scheduled return in accordance with this certificate, and has not been outside Mexico or the United States of America since exit from the European Union.
To spričevalo velja 10 dni.
V. The horse will be sent in a vehicle cleaned and disinfected in advance with a disinfectant officially approved in the third country of dispatch and designed in a way that droppings, litter or fodder cannot escape during transportation.
Datum
This certificate is valid for 10 days.
Kraj
Date
Žig in podpis uradnega veterinarja (1)
Place
Ime z velikimi tiskanimi črkami in službeni naziv.
Stamp and signature of the official veterinarian (1)
Barva žiga in podpisa se mora razlikovati od barve tiska.
Name in block capitals and capacity.
Spričevalo mora biti izdano na dan natovarjanja konja za odpošiljanje v Evropsko unijo ali na zadnji delovni dan pred vkrcanjem.
The colour of the stamp and the signature must be different from that of the printing.
Odločba Komisije 2004/211/ES z dne 6. januarja 2004 o uvedbi seznama tretjih držav in delov njihovega ozemlja, s katerih države članice dovolijo uvoz živih kopitarjev in semena, jajčnih celic in zarodkov vrste kopitarji, ter o spremembi odločb 93/195/EGS in 94/63/ES (UL L 73, 11.3.2004, str.
Commission Decision 2004/211/EC of 6 January 2004 establishing the list of third countries and parts of territory thereof from which Member States authorise imports of live equidae and semen, ova and embryos of the equine species, and amending Decisions 93/195/EEC and 94/63/EC (OJ L 73, 11.3.2004, p.
Neustrezno črtati.
1).
Vstavite datum vstopa [dd/mm/llll].
Delete as appropriate.
PRILOGA II
Insert date of entry [dd/mm/yyyy].
Tabela v Prilogi I k Odločbi 2004/211/ES se spremeni:
ANNEX II
V stolpcu 15 vrstice, ki se nanaša na regijo CN-2 Kitajske, se besede „veljavno od 15. aprila do 15. maja 2016“ nadomestijo z besedami: „veljavno od 20. aprila do 20. maja 2017“.
The table in Annex I to Decision 2004/211/EC is amended as follows:
V stolpcu 15 vrstice, ki se nanaša na regijo MX-1 Mehike, se besede „veljavno od 30. marca do 30. aprila 2016“ nadomestijo z besedami: „veljavno od 30. marca do 30. aprila 2017“.
In column 15 of the line corresponding to the region CN-2 of China, the words ‘Valid from 15 April to 15 May 2016’ are replaced by the words: ‘Valid from 20 April to 20 May 2017’.
Ker je metropolitansko območje Ciudad de México regija z visoko nadmorsko višino z zmanjšanim tveganjem vektorskega prenosa vezikularnega stomatitisa ali nekaterih podtipov venezuelskega encefalomielitisa enoprstih kopitarjev, bi bilo treba dovoliti ponovni vstop v Unijo registriranih konjev za dirke, tekmovanja in kulturne prireditve po njihovem začasnem izvozu za obdobje med 30. marcem 2017 in 30. aprilom 2017, krajše od 30 dni, na metropolitansko območje Ciudad de México, tj. v regijo, ki je bila več kot dve leti prosta venezuelskega encefalomielitisa enoprstih kopitarjev.
In column 15 of the line corresponding to the region MX-1 of Mexico, the words ‘Valid from 30 March to 30 April 2016’ are replaced by the words: ‘Valid from 30 March to 30 April 2017’.
Treba je spremeniti vnos za Mehiko na seznamu v Prilogi I k Odločbi 2004/211/ES.
Political and Security Committee Decision (CFSP) 2017/112
Sklep Političnega in varnostnega odbora (SZVP) 2017/112
appointing the EU Mission Commander for the European Union CSDP Military Training Mission in the Central African Republic (EUTM RCA) (EUTM RCA/1/2017)
o imenovanju poveljnika misije EU v misiji Evropske unije za vojaško usposabljanje v okviru SVOP v Srednjeafriški republiki (EUTM RCA) (EUTM RCA/1/2017)
Having regard to Council Decision (CFSP) 2016/610 of 19 April 2016 on a European Union CSDP Military Training Mission in the Central African Republic (EUTM RCA) [1], and in particular Article 5 thereof,
ob upoštevanju Sklepa Sveta (SZVP) 2016/610 z dne 19. aprila 2016 o misiji Evropske unije za vojaško usposabljanje v okviru SVOP v Srednjeafriški republiki (EUTM RCA) [1] in zlasti člena 5 Sklepa,
Decision (CFSP) 2016/610 appointed Brigadier General Eric HAUTECLOQUE-RAYSZ as EU Mission Commander of EUTM RCA.
S Sklepom (SZVP) 2016/610 je bil za poveljnika misije EU za EUTM RCA imenovan brigadni general Eric HAUTECLOQUE-RAYSZ.
Pursuant to Article 5(1) of Decision (CFSP) 2016/610, the Council authorised the Political and Security Committee (PSC), in accordance with Article 38 of the Treaty on European Union, to take the relevant decisions on the appointment of subsequent EU Mission Commanders.
V skladu s členom 5(1) Sklepa (SZVP) 2016/610 je Svet pooblastil Politični in varnostni odbor (PVO) za sprejemanje ustreznih odločitev o imenovanju naslednjih poveljnikov misije EU v skladu s členom 38 Pogodbe o Evropski uniji.
On 16 November 2016, the EU Military Committee recommended to approve the nomination of Brigadier General Herman RUYS, proposed by Eurocorps Common Committee, as the new EU Mission Commander for EUTM RCA to succeed Brigadier General Eric HAUTECLOQUE-RAYSZ as from 16 January 2017.
Vojaški odbor EU je 16. novembra 2016 priporočil, da se odobri predlog Skupnega odbora Eurocorps o imenovanju brigadnega generala Hermana RUYSA za novega poveljnika misije EU za EUTM RCA, ki bi od 16. januarja 2017 nasledil brigadnega generala Erica HAUTECLOQUA-RAYSZA.
Brigadier General Herman RUYS is hereby appointed EU Mission Commander for the European Union CSDP Military Training Mission in the Central African Republic (EUTM RCA) from 16 January 2017.
Brigadni general Herman RUYS je od 16. januarja 2017 imenovan za poveljnika misije EU v misiji Evropske unije za vojaško usposabljanje v okviru SVOP v Srednjeafriški republiki (EUTM RCA).
Political and Security Committee Decision (CFSP) 2017/113
Sklep Političnega in varnostnega odbora (SZVP) 2017/113
extending the mandate of the Head of Mission of the European Union Advisory Mission for Civilian Security Sector Reform Ukraine (EUAM Ukraine) (EUAM UKRAINE/1/2017)
o podaljšanju mandata vodje svetovalne misije Evropske unije za reformo sektorja civilne varnosti v Ukrajini (EUAM Ukraine) (EUAM UKRAINE/1/2017)
Having regard to the Council Decision 2014/486/CFSP of 22 July 2014 on the European Union Advisory Mission for Civilian Security Sector Reform Ukraine (EUAM Ukraine) [1], and in particular Article 7(1) thereof,
ob upoštevanju Sklepa Sveta 2014/486/SZVP z dne 22. julija 2014 o svetovalni misiji Evropske unije za reformo sektorja civilne varnosti v Ukrajini (EUAM Ukraine) [1] in zlasti člena 7(1) Sklepa,
Pursuant to Decision 2014/486/CFSP, the Political and Security Committee (PSC) is authorised, in accordance with Article 38 of the Treaty, to take the relevant decisions for the purpose of exercising the political control and strategic direction of the European Union Advisory Mission for Civilian Security Sector Reform Ukraine (EUAM Ukraine), including the decision to appoint a Head of Mission.
Politični in varnostni odbor (PVO) je na podlagi Sklepa 2014/486/SZVP pooblaščen, da v skladu s členom 38 Pogodbe sprejme ustrezne odločitve glede izvajanja političnega nadzora in strateškega vodenja svetovalne misije Evropske unije za reformo sektorja civilne varnosti v Ukrajini (EUAM Ukraine), vključno z odločitvijo o imenovanju vodje misije.
On 7 January 2016 the PSC adopted Decision EUAM UKRAINE/1/2016 [2], appointing Kęstutis LANČINSKAS as Head of Mission of EUAM Ukraine from 1 February 2016 to 31 January 2017.
PVO je 7. januarja 2016 sprejel Sklep EUAM UKRAINE/1/2016 [2], s katerim je za vodjo misije EUAM Ukraine od 1. februarja 2016 do 31. januarja 2017 imenoval Kęstutisa LANČINSKASA.
The High Representative of the Union for Foreign Affairs and Security Policy has proposed to extend the mandate of Kęstutis LANČINSKAS as Head of Mission of EUAM Ukraine from 1 February 2017 to 30 November 2017,
Visoki predstavnik Unije za zunanje zadeve in varnostno politiko je predlagal, naj se mandat Kęstutisa LANČINSKASA kot vodje misije EUAM Ukraine podaljša za obdobje od 1. februarja 2017 do 30. novembra 2017 –
The mandate of Kęstutis LANČINSKAS as Head of Mission of EUAM Ukraine is hereby extended until 30 November 2017.
Mandat Kęstutisa LANČINSKASA kot vodje misije EUAM Ukraine se podaljša do 30. novembra 2017.
Political and Security Committee Decision (CFSP) 2016/49 of 7 January 2016 on the appointment of the Head of Mission of the European Union Advisory Mission for Civilian Security Sector Reform Ukraine (EUAM Ukraine) (EUAM UKRAINE/1/2016) (OJ L 12, 19.1.2016, p. 47).
Sklep Političnega in varnostnega odbora (SZVP) 2016/49 z dne 7. januarja 2016 o imenovanju vodje svetovalne misije Evropske unije za reformo sektorja civilne varnosti v Ukrajini (EUAM Ukraine) (EUAM UKRAINE/1/2016) (UL L 12, 19.1.2016, str. 47).
Political and Security Committee Decision (CFSP) 2017/114
Sklep Političnega in varnostnega odbora (SZVP) 2017/114
extending the mandate of the Head of the European Union Capacity Building Mission in Somalia (EUCAP Somalia/1/2017)
o podaljšanju mandata vodje misije Evropske unije za krepitev zmogljivosti v Somaliji (EUCAP Somalia/1/2017)
Having regard to Council Decision 2012/389/CFSP of 16 July 2012 on the European Union Capacity Building Mission in Somalia (EUCAP Somalia) [1], and in particular Article 9(1) thereof,
ob upoštevanju Sklepa Sveta 2012/389/SZVP z dne 16. julija 2012 o misiji Evropske unije za krepitev zmogljivosti v Somaliji (EUCAP Somalia) [1] in zlasti člena 9(1) Sklepa,
Pursuant to Article 9(1) of Decision 2012/389/CFSP, the Political and Security Committee (PSC) is authorised, in accordance with the third paragraph of Article 38 of the Treaty, to take the relevant decisions for the purpose of exercising the political control and strategic direction of the European Union Capacity Building Mission in Somalia (EUCAP Somalia), including the decision to appoint a Head of Mission.
Politični in varnostni odbor (PVO) je na podlagi člena 9(1) Sklepa 2012/389/SZVP pooblaščen, da v skladu s tretjim odstavkom člena 38 Pogodbe sprejme ustrezne odločitve za izvajanje političnega nadzora in strateškega vodenja misije Evropske unije za krepitev zmogljivosti v Somaliji (EUCAP Somalia), vključno z odločitvijo o imenovanju vodje misije.
On 26 July 2016, the PSC adopted Decision EUCAP NESTOR/1/2016 [2], appointing Ms Maria-Cristina STEPANESCU as Head of EUCAP NESTOR from 1 September 2016 to 12 December 2016.
PVO je 26. julija 2016 sprejel Sklep EUCAP NESTOR/1/2016 [2], s katerim je bila za vodjo EUCAP NESTOR od 1. septembra 2016 do 12. decembra 2016 imenovana Maria-Cristina STEPANESCU.
Council Decision (CFSP) 2016/2240 [3] extended the mandate of the Mission EUCAP NESTOR until 31 December 2018 renaming it ‘EUCAP Somalia’.
S Sklepom Sveta (SZVP) 2016/2240 [3] je bil mandat misije EUCAP NESTOR podaljšan do 31. decembra 2018, pri čemer je bila misija preimenovana v „EUCAP Somalia“.
On 9 December 2016, the High Representative of the Union for Foreign Affairs and Security Policy proposed to extend the mandate of Ms Maria-Cristina STEPANESCU as Head of EUCAP Somalia from 13 December 2016 to 12 December 2017,
Visoki predstavnik Unije za zunanje zadeve in varnostno politiko je 9. decembra 2016 predlagal, da se mandat Marie-Cristine STEPANESCU kot vodje EUCAP Somalia podaljša za obdobje od 13. decembra 2016 do 12. decembra 2017 –
The mandate of Ms Maria-Cristina STEPANESCU as Head of the European Union Capacity Building Mission in Somalia (EUCAP Somalia) is extended until 12 December 2017.
Mandat Marie-Cristine STEPANESCU kot vodje misije Evropske unije za krepitev zmogljivosti v Somaliji (EUCAP Somalia) se podaljša do 12. decembra 2017.
It shall apply from 12 December 2016.
Uporablja se od 12. decembra 2016.
Political and Security Committee Decision (CFSP) 2016/1633 of 26 July 2016 on the appointment of the Head of Mission of the European Union Mission on Regional Maritime Capacity Building in the Horn of Africa (EUCAP NESTOR) (EUCAP NESTOR/1/2016) (OJ L 243, 10.9.2016, p. 8).
Sklep Političnega in varnostnega odbora (SZVP) 2016/1633 z dne 26. julija 2016 o imenovanju vodje misije Evropske unije za krepitev regionalnih pomorskih zmogljivosti v državah Afriškega roga (EUCAP NESTOR) (EUCAP NESTOR/1/2016) (UL L 243, 10.9.2016, str. 8).
Council Decision (CFSP) 2016/2240 of 12 December 2016 amending Decision 2012/389/CFSP on the European Union Mission on Regional Maritime Capacity Building in the Horn of Africa (EUCAP NESTOR) (OJ L 337, 13.12.2016, p. 18).
Sklep Sveta (SZVP) 2016/2240 z dne 12. decembra 2016 o spremembi Sklepa 2012/389/SZVP o misiji Evropske unije za krepitev regionalnih pomorskih zmogljivosti v državah Afriškega roga (EUCAP NESTOR) (UL L 337, 13.12.2016, str. 18).
Commission Implementing Decision (EU) 2017/115
Izvedbeni sklep Komisije (EU) 2017/115
of 20 January 2017
z dne 20. januarja 2017
authorising the placing on the market of fermented soybean extract as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
o odobritvi dajanja na trg ekstrakta fermentirane soje kot nove živilske sestavine v skladu z Uredbo (ES) št. 258/97 Evropskega parlamenta in Sveta
(notified under document C(2017) 165)
(notificirano pod dokumentarno številko C(2017) 165)
Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients [1], and in particular Article 7(1) thereof,
ob upoštevanju Uredbe (ES) št. 258/97 Evropskega parlamenta in Sveta z dne 27. januarja 1997 v zvezi z novimi živili in novimi živilskimi sestavinami [1] ter zlasti člena 7(1) Uredbe,
On 8 May 2014, the company Japan Bio Science Laboratory made a request to the competent authorities of Belgium to place fermented soybean extract on the Union market as a novel food ingredient within the meaning of point (d) of Article 1(2) of Regulation (EC) No 258/97.
Družba Japan Bio Science Laboratory je 8. maja 2014 pri pristojnih organih Belgije vložila zahtevek za dajanje na trg Unije ekstrakta fermentirane soje kot nove živilske sestavine v smislu točke (d) člena 1(2) Uredbe (ES) št. 258/97.
The application excluded from the use pregnant and lactating women.
V zahtevku so iz uporabe izključene nosečnice in doječe matere.
On 1 December 2014, the competent food assessment body of Belgium issued its initial assessment report.
Belgijski pristojni organ za presojo živil je 1. decembra 2014 izdal poročilo o začetni presoji.
In that report it came to the conclusion that fermented soybean extract meets the criteria for novel food ingredients set out in Article 3(1) of Regulation (EC) No 258/97.
V navedenem poročilu je ugotovil, da ekstrakt fermentirane soje izpolnjuje merila za nove živilske sestavine iz člena 3(1) Uredbe (ES) št. 258/97.
On 6 January 2015, the Commission forwarded the initial assessment report to the other Member States.
Komisija je 6. januarja 2015 poročilo o začetni presoji poslala drugim državam članicam.
Reasoned objections were raised by other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.
Te so v roku 60 dni, ki je določen v prvem pododstavku člena 6(4) Uredbe (ES) št. 258/97, vložile upravičene ugovore.
On 22 April 2015, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for fermented soybean extract as novel food ingredient in accordance with Regulation (EC) No 258/97.
Komisija se je 22. aprila 2015 posvetovala z Evropsko agencijo za varnost hrane (v nadaljnjem besedilu: Agencija) in jo zaprosila za dodatno presojo ekstrakta fermentirane soje kot nove živilske sestavine v skladu z Uredbo (ES) št. 258/97.
On 28 June 2016, EFSA concluded in its opinion on the safety of fermented soybean extract as a novel food [2] that fermented soybean extract used in food supplements intended for adults is safe under the conditions of use proposed by the applicant limiting consumption per day to a maximum dose of 100 mg.
Agencija je 28. junija 2016 v svojem mnenju o varnosti ekstrakta fermentirane soje kot novega živila [2] ugotovila, da je ekstrakt fermentirane soje, ki se uporablja v prehranskih dopolnilih za odrasle, varen pod pogoji uporabe, ki jih je predlagal prosilec, z omejitvijo dnevne porabe na največji odmerek 100 mg.
That opinion gives sufficient grounds to establish that fermented soybean extract as a novel food ingredient complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
Navedeno mnenje vsebuje dovolj dokazov, da ekstrakt fermentirane soje kot nova živilska sestavina izpolnjuje merila iz člena 3(1) Uredbe (ES) št. 258/97.
In its opinion, EFSA noted that fermented soybean extract contains nattokinase which exhibits in vitro fibrinolytic activity and in vivo thrombolytic activity in animals when administered parenterally.
Agencija je v svojem mnenju navedla, da ekstrakt fermentirane soje vsebuje natokinazo s fibrinolitičnim delovanjem in vitro in trombolitičnim delovanjem in vivo pri živalih, kadar se uporablja parenteralno.
It is therefore necessary to inform consumers about the need of medical supervision in cases when fermented soybean extract is consumed in combination with medication.
Zato je treba potrošnike obvestiti, da je potreben zdravniški nadzor, kadar se ekstrakt fermentirane soje uživa v kombinaciji z zdravili.
In its opinion, EFSA concludes that the margin of exposure is sufficient considering the maximum intake level for fermented soybean extract proposed by the applicant.
Agencija je v svojem mnenju ugotovila, da stopnja izpostavljenosti zadostuje glede na največji vnos ekstrakta fermentirane soje, ki ga je predlagal prosilec.
In its opinion, EFSA considers that the risk of allergic reaction to fermented soybean extract is similar to that associated with other soy-derived products which are to be labelled pursuant to Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council [3].
Agencija v svojem mnenju meni, da je tveganje alergijskega odziva na ekstrakt fermentirane soje podobno kot pri drugih iz soje pridobljenih proizvodih, ki jih je treba označiti v skladu s Prilogo II k Uredbi (EU) št. 1169/2011 Evropskega parlamenta in Sveta [3].
Therefore, the novel food ingredient should be labelled in accordance with Article 8 of Regulation (EC) No 258/97 and Regulation (EU) No 1169/2011.
Zato bi morala biti nova živilska sestavina označena v skladu s členom 8 Uredbe (ES) št. 258/97 in z Uredbo (EU) št. 1169/2011.
Directive 2002/46/EC of the European Parliament and of the Council [4] lays down requirements for food supplements.
Direktiva 2002/46/ES Evropskega parlamenta in Sveta [4] določa zahteve za prehranska dopolnila.