natgillin/translations-raw huggingface dataset:
Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
Komisija in države članice so 16. julija 2014 prejele znanstveno mnenje Agencije, ki je ugotovila, da predloženi dokazi ne zadostujejo za vzpostavitev vzročno-posledične povezave med uživanjem standardiziranega vodnega izvlečka iz navadnega fižola (Phaseolus vulgaris L.) in zmanjšanjem telesne teže.
Following an application from Natural Alternative International, Inc.
Ker zdravstvena trditev ne izpolnjuje zahtev iz Uredbe (ES) št. 1924/2006, se ne bi smela odobriti.
(NAI), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to beta-alanine and increase in physical performance during short-duration, high-intensity exercise (Question No EFSA-Q-2013-00974 [3]).
Družba Natural Alternative International, Inc.
The claim proposed by the applicant was worded as follows: ‘Beta-alanine increases performance during short-duration high intensity exercise’.
(NAI) je v skladu s členom 13(5) Uredbe (ES) št. 1924/2006 vložila vlogo, Agencija pa je morala pripraviti mnenje o zdravstveni trditvi v zvezi z beta-alaninom in povečanjem telesne zmogljivosti med kratkotrajno in visokointenzivno vadbo (vprašanje št.
On 16 July 2014, the Commission and the Member States received the scientific opinion from the Authority, which concluded that a cause and effect relationship had not been established between the consumption of beta-alanine and increase in physical performance during short-duration, high-intensity exercise.
EFSA-Q-2013-00974 [3]).
Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
Vložnik je predlagal naslednjo trditev: „Beta-alanin poveča zmogljivost med kratkotrajno in zelo intenzivno vadbo.“
Following an application from Federación Nacional de Industrias Lácteas (FeNIL), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to fat-free yogurts and fermented milks complying with the specifications ‘fat free’, ‘low in sugars’, ‘high protein’, ‘source of calcium’ and ‘source of vitamin D’ for nutrition claims and reduction of body and visceral fat while maintaining lean body mass in the context of an energy-restricted diet (Question No EFSA-Q-2014-00126 [4]).
Komisija in države članice so 16. julija 2014 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem beta-alanina in povečanjem telesne zmogljivosti med kratkotrajno in visokointezivno vadbo ni utemeljena.
The claim proposed by the applicant was worded as follows: ‘Fat-free yogurts and fermented milks with live yogurt cultures, with added vitamin D, and with no added sugars, help to reduce body and visceral fat in the context of an energy-restricted diet’.
Ker zdravstvena trditev ne izpolnjuje zahtev iz Uredbe (ES) št. 1924/2006, se ne bi smela odobriti.
On 7 January 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that a cause and effect relationship had not been established between the consumption of fat-free yogurts and fermented milks with live yogurt cultures complying with the specifications ‘fat free’, ‘low in sugars’, ‘high protein’, ‘source of calcium’ and ‘source of vitamin D’ for nutrition claims and reduction of body and visceral fat while maintaining lean body mass in the context of an energy-restricted diet.
Organizacija Federación nacional de Industrias lácteas (FeNIL) je v skladu s členom 13(5) Uredbe (ES) št. 1924/2006 vložila vlogo, Agencija pa je morala pripraviti mnenje o zdravstveni trditvi v zvezi z nemastnimi jogurti in fermentiranim mlekom, ki izpolnjujejo zahteve za navedbo prehranskih trditev „nemastno“, „nizka vsebnost sladkorjev“, „visoka vsebnost beljakovin“, „vir kalcija“ in „vir vitamina D“, in zmanjšanjem telesne in trebušne maščobe ob ohranjanju vitke telesne mase v okviru energijsko omejene diete za zmanjšanje telesne teže (vprašanje št.
In that opinion, the Authority also noted that no human studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant.
EFSA-Q- 2014-00126 [4]).
Following an application from Federación Nacional de Industrias Lácteas (FeNIL), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to fat-free yogurts and fermented milks with live yogurt cultures complying with the specifications ‘fat free’, ‘low in sugars’, ‘high protein’, ‘source of calcium’ and ‘source of vitamin D’ for nutrition claims and maintenance of lean body mass in the context of an energy-restricted diet (Question No EFSA-Q-2014-00127 [5]).
Vložnik je predlagal naslednjo trditev: „Nemastni jogurti in fermentirano mleko z živimi jogurtovimi kulturami, z dodanim vitaminom D in brez dodanih sladkorjev pomagajo zmanjšati telesno in trebušno maščobo v okviru energijsko omejene diete za zmanjšanje telesne teže.“
The claim proposed by the applicant was worded as follows: ‘Fat-free yogurts and fermented milks with live yogurt cultures, with added vitamin D, and with no added sugars, help to maintain lean body mass (muscle and bone) in the context of an energy-restricted diet’.
Komisija in države članice so 7. januarja 2015 prejele znanstveno mnenje Agencije, ki je ugotovila, da vzročno-posledična povezava med uživanjem nemastnih jogurtov in fermentiranega mleka z živimi jogurtovimi kulturami, ki izpolnjujejo zahteve za navedbo prehranskih trditev „nemastno“, „nizka vsebnost sladkorjev“, „visoka vsebnost beljakovin“, „vir kalcija“ in „vir vitamina D“, in zmanjšanjem telesne in trebušne maščobe ob ohranjanju vitke telesne mase v okviru energijsko omejene diete za zmanjšanje telesne teže ni utemeljena.
On 7 January 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that a cause and effect relationship had not been established between the consumption of fat-free yogurts and fermented milks with live yogurt cultures complying with the specifications ‘fat free’, ‘low in sugars’, ‘high protein’, ‘source of calcium’ and ‘source of vitamin D’ for nutrition claims and maintenance of lean body mass in the context of an energy-restricted diet.
V navedenem mnenju je Agencija tudi navedla, da vložnik ni predložil nobenih študij na ljudeh, iz katerih bi bilo mogoče sprejeti sklepe o znanstveni utemeljitvi trditve.
In that opinion, the Authority also noted that no human studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant.
Organizacija Federación nacional de Industrias lácteas (FeNIL) je v skladu s členom 13(5) Uredbe (ES) št. 1924/2006 vložila vlogo, Agencija pa je morala pripraviti mnenje o zdravstveni trditvi v zvezi z nemastnimi jogurti in fermentiranim mlekom z živimi jogurtovimi kulturami, ki izpolnjujejo zahteve za navedbo prehranskih trditev „nemastno“, „nizka vsebnost sladkorjev“, „visoka vsebnost beljakovin“, „vir kalcija“ in „vir vitamina D“, in ohranjanjem vitke telesne mase v okviru energijsko omejene diete za zmanjšanje telesne teže (vprašanje št.
Following an application from Avesthagen Limited, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Teestar™, a fenugreek seed extract standardised by its content of galactomannan, and a reduction of post-prandial glycaemic responses (Question No EFSA-Q-2014-00153 [6]).
EFSA-Q- 2014-00127 [5]).
The claim proposed by the applicant was worded as follows: ‘Teestar™ lowers blood glucose levels’.
Vložnik je predlagal naslednjo trditev: „Nemastni jogurti in fermentirano mleko z živimi jogurtovimi kulturami, z dodanim vitaminom D in brez dodanih sladkorjev pomagajo ohranjati pusto telesno maso (mišice in kosti) v okviru energijsko omejene diete za zmanjšanje telesne teže.“
On 8 January 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that a cause and effect relationship had not been established between the consumption of Teestar™, a fenugreek seed extract standardised by its content of galactomannan, and a reduction of post-prandial glycaemic responses.
Komisija in države članice so 7. januarja 2015 prejele znanstveno mnenje Agencije, ki je ugotovila, da vzročno-posledična povezava med uživanjem nemastnih jogurtov in fermentiranega mleka z živimi jogurtovimi kulturami, ki izpolnjujejo zahteve za navedbo prehranske trditve „nemastno“, „nizka vsebnost sladkorjev“, „visoka vsebnost beljakovin“, „vir kalcija“ in „vir vitamina D“, in ohranjanjem puste telesne mase v okviru energijsko omejene diete za zmanjšanje telesne teže ni utemeljena.
In that opinion, the Authority also noted that in the absence of evidence for an effect of Teestar™ on post-prandial glycaemic responses in humans, animal studies on potential mechanisms do not provide support for the scientific substantiation of the claim.
V navedenem mnenju je Agencija tudi navedla, da vložnik ni predložil nobenih študij na ljudeh, iz katerih bi bilo mogoče sprejeti sklepe o znanstveni utemeljitvi trditve.
The comments from the applicants received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.
Družba Avesthagen Limited je v skladu s členom 13(5) Uredbe (ES) št. 1924/2006 vložila vlogo, Agencija pa je morala pripraviti mnenje o zdravstveni trditvi v zvezi z izdelkom Teestar™, izvlečkom iz semena triplata, standardiziranega po vsebnosti galaktomanana, in zmanjšanjem postprandialnega glikemičnega odziva (vprašanje št.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
EFSA-Q-2014-00153 [6]).
HAS ADOPTED THIS REGULATION:
Vložnik je predlagal naslednjo trditev: „Teestar™ zniža raven glukoze v krvi.“
Article 1
Komisija in države članice so 8. januarja 2015 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem izdelka Teestar™, izvlečka iz semena triplata, standardiziranega po vsebnosti galaktomanana, in zmanjšanjem postprandialnega glikemičnega odziva ni utemeljena.
The health claims listed in the Annex to this Regulation shall not be included in the Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.
V navedenem mnenju je Agencija tudi navedla, da dokazov o učinku izdelka Teestar™ na glikemični odziv pri ljudeh ni, študije na živalih o možnih mehanizmih pa ne zadostujejo za znanstveno utemeljitev trditve.
Article 2
Pri določanju ukrepov iz te uredbe so bile upoštevane pripombe, ki so jih vložniki poslali Komisiji v skladu s členom 16(6) Uredbe (ES) št. 1924/2006.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za rastline, živali, hrano in krmo –
Done at Brussels, 15 March 2016.
Člen 1
The President
Člen 2
EFSA Journal 2015;13(1):3952.
UL L 404, 30.12.2006, str. 9.
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data
Zdravstvena trditev po členu 13(5), ki je utemeljena na novih znanstvenih dokazih in/ali vključuje zahtevo za zakonsko zaščito podatkov
Standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.)
Standardizirani vodni izvleček iz navadnega fižola (Phaseolus vulgaris L.)
Helps to reduce body weight
Pomaga zmanjšati telesno težo.
Beta-alanine increases performance during short-duration high intensity exercise
Beta-alanin poveča zmogljivost med kratkotrajno in zelo intenzivno vadbo.
Fat-free yogurts and fermented milks with live yogurt cultures complying with the specifications ‘fat free’, ‘low in sugars’, ‘high protein’, ‘source of calcium’ and ‘source of vitamin D’ for nutrition claims
Nemastni jogurti in fermentirano mleko z živimi jogurtovimi kulturami, ki izpolnjujejo zahteve za navedbo prehranskih trditev „nemastno“, „nizka vsebnost sladkorjev“, „visoka vsebnost beljakovin“, „vir kalcija“ in „vir vitamina D“
Fat-free yogurts and fermented milks with live yogurt cultures, with added vitamin D, and with no added sugars, help to reduce body and visceral fat in the context of an energy-restricted diet
Nemastni jogurti in fermentirano mleko z živimi jogurtovimi kulturami, z dodanim vitaminom D in brez dodanih sladkorjev pomagajo zmanjšati telesno in trebušno maščobo v okviru energijsko omejene diete za zmanjšanje telesne teže.
Fat-free yogurts and fermented milks with live yogurt cultures, with added vitamin D, and with no added sugars, help to maintain lean body mass (muscle and bone) in the context of an energy-restricted diet
Nemastni jogurti in fermentirano mleko z živimi jogurtovimi kulturami, z dodanim vitaminom D in brez dodanih sladkorjev pomagajo ohranjati pusto telesno maso (mišice in kosti) v okviru energijsko omejene diete za zmanjšanje telesne teže.
Teestar™, a fenugreek seed extract standardised by its content of galactomannan
Izdelek Teestar™, izvleček iz semena triplata, standardiziranega po vsebnosti galaktomanana
refusing to authorise a health claim made on foods and referring to the reduction of disease risk
o zavrnitvi odobritve zdravstvene trditve na živilih, ki se nanaša na zmanjšanje tveganja za nastanek bolezni
Following an application from Lycotec Ltd, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to L-tug lycopene and reduction of blood low-density lipoprotein (LDL)-cholesterol (Question No EFSA-Q-2014-00590 [2]).
Družba Lycotec Ltd je v skladu s členom 14(1)(a) Uredbe (ES) št. 1924/2006 predložila vlogo, Agencija pa je morala pripraviti mnenje o zdravstveni trditvi v zvezi z učinki L-tug likopena in znižanjem lipoproteinov majhne gostote (LDL)-holesterola v krvi (vprašanje št.
The claim proposed by the applicant was worded as follows: ‘L-tug lycopene has been shown to lower/reduce blood cholesterol.
EFSA-Q-2014-00590 [2]).
High cholesterol is a risk factor in the development of coronary heart disease’.
Vložnik je predlagal naslednjo trditev: „L-tug likopen dokazano znižuje/zmanjšuje raven holesterola v krvi.
On 26 February 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, a cause and effect relationship had not been established between the consumption of L-tug lycopene and reduction of blood LDL-cholesterol concentrations.
Povišan holesterol je dejavnik tveganja za razvoj koronarne srčne bolezni.“
Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
Komisija in države članice so 26. februarja 2015 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem L-tug likopena in znižanjem LDL-holesterola v krvi ni bila utemeljena.
The measure provided for in this Regulation is in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Ker zdravstvena trditev ne izpolnjuje zahtev iz Uredbe (ES) št. 1924/2006, se ne bi smela odobriti.
HAS ADOPTED THIS REGULATION:
Ukrep iz te uredbe je v skladu z mnenjem Stalnega odbora za rastline, živali, hrano in krmo –
The health claim listed in the Annex to this Regulation shall not be included in the Union list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006.
Člen 1
Article 2
Zdravstvena trditev iz Priloge k tej uredbi se ne uvrsti na seznam dovoljenih trditev Unije v skladu s členom 14(1) Uredbe (ES) št. 1924/2006.
For the Commission
V Bruslju, 15. marca 2016
EFSA Journal 2015;13(2):4025.
UL L 404, 30.12.2006, str. 9.
Article 14(1)(a) health claim referring to a reduction of a disease risk.
Zdravstvena trditev po členu 14(1)(a), ki se nanaša na zmanjšanje tveganja za nastanek bolezni.
L-tug lycopene has been shown to lower/reduce blood cholesterol.
L-tug likopen dokazano znižuje/zmanjšuje raven holesterola v krvi.
Commission Implementing Regulation (EU) 2016/378
Izvedbena uredba Komisije (EU) 2016/378
laying down implementing technical standards with regard to the timing, format and template of the submission of notifications to competent authorities according to Regulation (EU) No 596/2014 of the European Parliament and of the Council
o določitvi izvedbenih tehničnih standardov glede časa, oblike in predloge za predložitev uradnih obvestil pristojnim organom v skladu z Uredbo (EU) št. 596/2014 Evropskega parlamenta in Sveta
Having regard to Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC [1], and in particular, the third subparagraph of Article 4(5) thereof,
ob upoštevanju Uredbe (EU) št. 596/2014 Evropskega parlamenta in Sveta z dne 16. aprila 2014 o zlorabi trga (uredba o zlorabi trga) ter razveljavitvi Direktive 2003/6/ES Evropskega parlamenta in Sveta ter direktiv Sveta in Komisije 2003/124/ES, 2003/125/ES in 2004/72/ES [1] ter zlasti tretjega pododstavka člena 4(5) Uredbe;
In order to ensure the coherence of reporting obligations and to reduce the administrative burden for entities subject to such obligations, it is necessary to align the reporting obligations under this Regulation and under Commission Delegated Regulation to be adopted in accordance with the third subparagraph of Article 27(3) of Regulation (EU) No 600/2014 of the European Parliament and of the Council [2].
Da bi se zagotovila skladnost poročevalskih obveznosti ter zmanjšalo upravno breme za subjekte, za katere veljajo take obveznosti, je treba uskladiti poročevalske obveznosti na podlagi te uredbe in tiste na podlagi Delegirane uredbe Komisije, ki bo sprejeta v skladu s tretjim pododstavkom člena 27(3) Uredbe (EU) št. 600/2014 Evropskega parlamenta in Sveta [2].
In order to enable the competent authorities and the European Securities and Markets Authority (ESMA) to ensure data quality and effective market monitoring, for the benefit of market integrity, the competent authorities and ESMA should be able to promptly receive complete notifications in respect of each trading day.
Da bi lahko pristojni organi in Evropski organ za vrednostne papirje in trge (v nadaljnjem besedilu: ESMA) zagotovili kakovost podatkov in učinkovito spremljanje trgov, bi bilo treba zavoljo povezanosti trgov pristojnim organom in ESMA omogočiti, da hitro prejemajo popolna obvestila v zvezi z vsakim trgovalnim dnevom.
For the purposes of effective and efficient use of data by competent authorities, there should be consistency in the templates and formats used when submitting notifications of financial instruments.
Za učinkovito uporabo podatkov s strani pristojnih organov, bi se morale za predložitve uradnih obvestil o finančnih instrumentih uporabljati skladne predloge in oblika.
Adherence to the relevant international standards with regard to the details included in those notifications promotes those purposes.
K temu bi prispevalo tudi spoštovanje zadevnih mednarodnih standardov v zvezi s podrobnostmi, ki se morajo vključiti v ta uradna obvestila.
This Regulation is based on the draft implementing technical standards submitted by ESMA to the Commission.
Ta uredba temelji na osnutkih izvedbenih tehničnih standardov, ki jih je ESMA predložila Komisiji.
ESMA has conducted open public consultations on the draft implementing technical standard on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Securities and Markets Stakeholder Group established by Article 37 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council [3].
ESMA je o osnutkih izvedbenih tehničnih standardov, na katerih temelji ta uredba, opravila javna posvetovanja, analizirala morebitne z njimi povezane stroške in koristi ter zaprosila za mnenje interesno skupino za vrednostne papirje in trge, ustanovljeno v skladu s členom 37 Uredbe (EU) št. 1095/2010 Evropskega parlamenta in Sveta [3].
In order to ensure the smooth functioning of the financial markets, it is necessary that this Regulation enters into force as a matter of urgency and that the provisions laid down in this Regulation apply from the same date as those laid down in Regulation (EU) No 596/2014,
Da bi zagotovili nemoteno delovanje finančnih trgov, bi morala ta uredba začeti veljati čim prej, določbe iz te uredbe pa bi morale veljati od istega datuma kot tiste iz Uredbe (EU) št. 596/2014 –
By no later than 21.00 CET on each day that it is open for trading, a trading venue shall, using automated processes, provide to its competent authority pursuant to Article 4(1) of Regulation (EU) No 596/2014 the notifications of all financial instruments which, before 18.00 CET on that day, were for the first time subject to a request for admission to trading or admitted to trading or traded on that trading venue, including where orders or quotes were placed through its system, or ceased to be traded or to be admitted to trading on the trading venue.
Mesto trgovanja z uporabo avtomatiziranih postopkov vsak dan, ki je odprt za trgovanje, najpozneje do 21:00 po srednjeevropskem času svojemu pristojnemu organu v skladu s členom 4(1) Uredbe (EU) št. 596/2014 predloži obvestila o vseh finančnih instrumentih, za katere je bil na ta dan pred 18:00 po srednjeevropskem času prvič vložen zahtevek za uvrstitev v trgovanje, ki so bili prvič uvrščeni v trgovanje ali s katerimi se je prvič trgovalo na navedenem mestu trgovanja, vključno z naročili in ponudbami, oddanimi prek njegovega sistema, oziroma o vseh finančnih instrumentih, s katerimi se je nehalo trgovati ali ki niso več uvrščeni v trgovanje na mestu trgovanja.
Notifications of financial instruments which, after 18.00 CET, were for the first time subject to a request for admission to trading or admitted to trading or traded on the trading venue, including where orders or quotes were placed through its system, or ceased to be traded or to be admitted to trading on the trading venue, shall be made, using automated processes, by the trading venue to the competent authority by no later than 21.00 CET of the next day on which it is open for trading.
Mesto trgovanja obvestila o finančnih instrumentih, za katere je bil prvič vložen zahtevek za uvrstitev v trgovanje, ki so bili prvič uvrščeni v trgovanje ali s katerimi se je prvič trgovalo na navedenem mestu trgovanja, vključno z naročili in ponudbami, oddanimi prek njegovega sistema, oziroma o finančnih instrumentih, s katerimi se je nehalo trgovati ali ki niso več uvrščeni v trgovanje na mestu trgovanja po 18:00 po srednjeevropskem času, pristojnemu organu z uporabo avtomatiziranih postopkov predloži naslednji dan, ki je odprt za trgovanje, najpozneje do 21:00 po srednjeevropskem času.
Competent authorities shall transmit notifications referred to in paragraphs 1 and 2 pursuant to Article 4(2) of Regulation (EU) No 596/2014 to ESMA each day by no later than 23.59 CET using automated processes and secure electronic communication channels between them and ESMA.
Pristojni organi v skladu s členom 4(2) Uredbe (EU) št. 596/2014 vsak dan najpozneje do 23:59 po srednjeevropskem času organu ESMA z uporabo avtomatiziranih postopkov in varnih elektronskih komunikacijskih kanalov med njimi in ESMA posredujejo obvestila iz odstavkov 1 in 2.