natgillin/translations-raw huggingface dataset:
refusing to authorise certain health claims made on foods and referring to the reduction of disease risk and to children’s development and health
o zavrnitvi odobritve nekaterih zdravstvenih trditev na živilih, ki se nanašajo na zmanjšanje tveganja za nastanek bolezni ter na razvoj in zdravje otrok
Following receipt of an application the Authority is to inform without delay the other Member States and the Commission of the application, and to deliver an opinion on a health claim concerned.
Agencija po prejemu vloge takoj obvesti druge države članice in Komisijo ter pripravi mnenje o zadevni zdravstveni trditvi.
On 13 February 2009 the Commission and the Member States received four opinions on applications for health claim authorisation from the Authority.
Komisija in države članice so 13. februarja 2009 prejele štiri mnenja Agencije o vlogah za odobritev zdravstvenih trditev.
On 16 March 2009, the Commission and the Member States received one opinion on an application for health claim authorisation from the Authority.
Komisija in države članice so 16. marca 2009 prejele eno mnenje Agencije o vlogi za odobritev zdravstvene trditve.
Two opinions were related to applications for reduction of disease risk claim, as referred to in Article 14(1)(a) of Regulation (EC) No 1924/2006, and three opinions were related to applications for health claims referring to children’s development and health, as referred to in Article 14(1)(b) of Regulation (EC) No 1924/2006.
Dve mnenji sta se nanašali na vlogi za zdravstveno trditev za zmanjšanje tveganja za nastanek bolezni, kakor je opredeljeno v členu 14(1)(a) Uredbe (ES) št. 1924/2006, tri mnenja pa so se nanašala na vloge za zdravstvene trditve v zvezi z razvojem in zdravjem otrok, kakor je opredeljeno v členu 14(1)(b) Uredbe (ES) št. 1924/2006.
Meanwhile one application for health claim authorisation will be subject to a further decision.
Ena vloga za odobritev zdravstvene trditve bo še obravnavana.
Following an application from the UNICER Bebidas de Portugal SGPS, 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 the effects of Melgaço® mineral water on the reduction of glycaemia (Question No EFSA-Q-2008-219) [2].
Družba UNICER Bebidas de Portugal SGPS 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 vplivi mineralne vode Melgaço® na zniževanje glukoze v krvi (vprašanje št. EFSA-Q-2008-219) [2].
The claim proposed by the applicant was worded as follows: ‘The regular consumption of Melgaço mineral water reduces body hyperglycaemic levels’.
Vlagatelj je predlagal naslednjo trditev: „Redno uživanje mineralne vode Melgaço znižuje visoke ravni krvnega sladkorja v telesu.“
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the consumption of Melgaço® mineral water and the claimed effect.
Agencija je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem mineralne vode Melgaço® in navedeno trditvijo ni utemeljena.
Following an application from the Ocean Spray International Services (UK) 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 the effects of Ocean Spray Cranberry Products® on urinary tract infection in women (Question No EFSA-Q-2008-117) [3].
Družba Ocean Spray International Services (UK) 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 vplivi Ocean Spray Cranberry Products® na okužbe sečil pri ženskah (vprašanje št. EFSA-Q-2008-117) [3].
The claim proposed by the applicant was worded as follows: ‘Regular consumption of 2 servings per day of an Ocean Spray product each containing typically 80 mg cranberry proanthocyanidins helps reduce the risk of urinary tract infection in women by inhibiting the adhesion of certain bacteria in the urinary tract’.
Vlagatelj je predlagal naslednjo trditev: „Redno dnevno uživanje dveh obrokov proizvoda Ocean Spray, ki običajno vsebuje 80 mg proantocianidinov iz brusnic, pomaga zmanjševati tveganje za okužbo sečil pri ženskah, ker preprečuje zadrževanje nekaterih bakterij v urinskem traktu.“
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the consumption of Ocean Spray Cranberry Products® and the claimed effect.
Agencija je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem Ocean Spray Cranberry Products® in navedeno trditvijo ni utemeljena.
Following an application from Soremartec Italia SRL, submitted pursuant to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of Kinder Chocolate® on growth (Question No EFSA-Q-2008-283) [4].
Družba Soremartec Italia S.R.L. je v skladu s členom 14(1)(b) Uredbe (ES) št. 1924/2006 predložila vlogo, Agencija pa je morala pripraviti mnenje o zdravstveni trditvi v zvezi z vplivi Kinder Chocolate® na rast (vprašanje št. EFSA-Q-2008-283) [4].
The claim proposed by the applicant was worded as follows: ‘Kinder Chocolate, the chocolate that helps to grow’.
Vlagatelj je predlagal naslednjo trditev: „Kinder Chocolate je čokolada, ki pomaga rasti.“
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the consumption of Kinder Chocolate® and the claimed effect.
Agencija je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem Kinder Chocolate® in navedeno trditvijo ni utemeljena.
Following an application from the Plada Industriale SRL, submitted pursuant to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of follow-on formulae with bioactive constituents on intestinal ailments (Question No EFSA-Q-2008-270) [5].
Družba Plada Industriale S.R.L. je v skladu s členom 14(1)(b) Uredbe (ES) št. 1924/2006 predložila vlogo, Agencija pa je morala pripraviti mnenje o zdravstveni trditvi v zvezi z vplivi nadaljevalnih formul za dojenčke z bioaktivnimi sestavinami na črevesne težave (vprašanje št. EFSA-Q-2008-270) [5].
The claim proposed by the applicant was worded as follows: ‘Aids minor intestinal ailments (as colic, constipation, digestive symptoms)’.
Vlagatelj je predlagal naslednjo trditev: „Pomaga pri manjših črevesnih težavah (kot so kolike, zaprtje, prebavne motnje)“.
On the basis of the data presented, the Authority concluded that a cause and effect relationship had not been established between the consumption of follow-on formulae with a fixed combination of short-chain galacto-oligosaccharides, acidified milk, nucleotides and beta-palmitate and the claimed effect.
Agencija je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem nadaljevalnih formul za dojenčke s fiksno kombinacijo kratkoverižnih galaktooligosaharidov, skisanega mleka, nukleotidov in betapalmitata ter navedeno trditvijo ni utemeljena.
In accordance with Article 28(6) of Regulation (EC) No 1924/2006 health claims referred to in its Article 14(1)(b) and not authorised by a decision pursuant to Article 17(3) of Regulation (EC) No 1924/2006 may continue to be used for six months after the adoption of this Regulation.
V skladu s členom 28(6) Uredbe (ES) št. 1924/2006 se zdravstvene trditve iz člena 14(1)(b) navedene uredbe, ki niso odobrene z odločbo v skladu s členom 17(3) Uredbe (ES) št. 1924/2006, lahko uporabljajo šest mesecev po sprejetju te uredbe.
However, as the concerned applications were not made before 19 January 2008 the requirement provided for in Article 28(6)(b) is not fulfilled, and the transition period laid down in that Article is not applicable.
Ker zadevne vloge niso bile predložene pred 19. januarjem 2008, zahteva iz člena 28(6)(b) ni izpolnjena in se prehodno obdobje iz navedenega člena ne uporablja.
The health claims set out in the Annex to this Regulation shall not be included in the Community list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006.
V skladu s členom 14(1) Uredbe (ES) št. 1924/2006 se zdravstvene trditve iz Priloge k tej uredbi ne uvrstijo na seznam dovoljenih trditev Skupnosti.
However, the health claims as referred to in Article 14(1)(b) of Regulation (EC) No 1924/2006 and set out in the Annex to this Regulation may continue to be used for six months after the entry into force of this Regulation.
Zdravstvene trditve iz člena 14(1)(b) Uredbe (ES) št. 1924/2006, ki so naštete v Prilogi k tej uredbi, se lahko uporabljajo še šest mesecev po začetku veljavnosti te uredbe.
The EFSA Journal (2009) 944, pp. 1-9.
The EFSA Journal (2009) 944, str. 1–9.
The EFSA Journal (2009) 943, pp. 1-16.
The EFSA Journal (2009) 943, str. 1–16.
The EFSA Journal (2009) 940, pp. 1-8.
The EFSA Journal (2009) 940, str. 1–8.
The EFSA Journal (2009) 939, pp. 1-10.
The EFSA Journal (2009) 939, str. 1–10.
Melgaço® mineral water
mineralna voda Melgaço®
The regular consumption of Melgaço mineral water reduces body hyperglycaemic levels
Redno uživanje mineralne vode Melgaço znižuje visoke ravni krvnega sladkorja v telesu.
Regular consumption of 2 servings per day of an Ocean Spray product each containing typically 80 mg cranberry proanthocyanidins helps reduce the risk of urinary tract infection in women by inhibiting the adhesion of certain bacteria in the urinary tract
Redno dnevno uživanje dveh obrokov proizvoda Ocean Spray, ki običajno vsebuje 80 mg proantocianidinov iz brusnic, pomaga zmanjševati tveganje za okužbo sečil pri ženskah, ker preprečuje zadrževanje nekaterih bakterij v urinskem traktu.
Kinder Chocolate, the chocolate that helps to grow
Kinder Chocolate je čokolada, ki pomaga rasti.
Follow-on formulae with a fixed combination of short-chain galacto-oligosaccharides, acidified milk, nucleotides and beta-palmitate
nadaljevalne formule za dojenčke s fiksno kombinacijo kratkoverižnih galaktooligosaharidov, skisanega mleka, nukleotidov in betapalmitata
Aids minor intestinal ailments (as colic, constipation, digestive symptoms)
Pomaga pri manjših črevesnih težavah (kot so kolike, zaprtje, prebavne motnje).
Commission Regulation (EC) No 1168/2009
Uredba Komisije (ES) št. 1168/2009
refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children’s development and health
o zavrnitvi odobritve zdravstvene trditve na živilih, razen tistih, ki se nanašajo na zmanjšanje tveganja za nastanek bolezni ter na razvoj in zdravje otrok
Following an application from Brudy Technology SL, submitted on 9 October 2008 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 the effects of Algatrium® on antioxidant response (Question No EFSA-Q-2008-705) [2].
Družba Brudy Technology S.L je 9. oktobra 2008 v skladu s členom 13(5) Uredbe (ES) št. 1924/2006 predložila vlogo, Agencija pa je morala pripraviti mnenje o zdravstveni trditvi v zvezi z učinki Algatrium® na antioksidativni odziv (Vprašanje št. EFSA-Q-2008-705) [2].
The claim proposed by the applicant was worded as follows: ‘Algatrium® promotes your antioxidant response: a singular nutritional substance that has scientifically demonstrated in humans a stimulation of the own cells antioxidant defences’.
Vlagatelj je predlagal naslednjo trditev: „Algatrium® spodbuja vaš antioksidativni odziv: edina prehranska snov, ki znanstveno dokazano pri ljudeh spodbuja lastne celice antioksidativne obrambe“.
On 16 March 2009, 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 Algatrium® and the claimed effect.
Komisija in države članice so 16. marca 2009 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem Algatrium® in navedeno trditvijo ni utemeljena.
The comments from the applicants and the members of the public 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.
Pri določanju ukrepov iz te uredbe so bile upoštevane pripombe, ki so jih vlagatelji in predstavniki javnosti poslali Komisiji v skladu s členom 16(6) Uredbe (ES) št. 1924/2006.
Health claims referred to in Article 13(1)(a) of Regulation (EC) No 1924/2006 are subject to the transition measures laid down in Article 28(5) of that Regulation.
Zdravstvene trditve iz člena 13(1)(a) Uredbe (ES) št. 1924/2006 so predmet prehodnega ukrepa iz člena 28(5) navedene uredbe.
However, for the health claim ‘Algatrium® promotes your antioxidant response: a singular nutritional substance that has scientifically demonstrated in humans a stimulation of the own cells antioxidant defences’, the Authority concluded that a cause and effect relationship had not been established between the consumption of Algatrium® and the claimed effect.
Vendar je Agencija v zvezi z zdravstveno trditvijo „Algatrium® spodbuja vaš antioksidativni odziv: edina prehranska snov, ki znanstveno dokazano pri ljudeh spodbuja lastne celice antioksidativne obrambe“, ugotovila, da vzročno-posledična povezava med uživanjem Algatrium® in navedeno trditvijo ni utemeljena.
Therefore, the claim does not comply with Regulation (EC) No 1924/2006, and consequently the transition period foreseen in Article 28(5) of that Regulation is not applicable.
Zato navedena trditev ni v skladu z Uredbo (ES) št. 1924/2006 in se prehodno obdobje iz člena 28(5) navedene uredbe ne uporablja.
A transition period of six months should be provided for, to enable food business operators to adapt to the requirements laid down in this Regulation.
Določiti je treba šestmesečno prehodno obdobje, da se nosilci živilske dejavnosti lahko prilagodijo zahtevam iz te uredbe.
The health claim set out in the Annex to this Regulation shall not be included in the Community list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.
Zdravstvena trditev iz Priloge k tej uredbi se ne uvrsti na seznam dovoljenih trditev Skupnosti v skladu s členom 13(3) Uredbe (ES) št. 1924/2006.
However, it may continue to be used for six months after the entry into force of this Regulation.
Navedena zdravstvena trditev se lahko uporablja šest mesecev po začetku veljavnosti te uredbe.
The EFSA Journal (2009) 942, pp. 1-9.
The EFSA Journal (2009) 942, str. 1–9.
REJECTED HEALTH CLAIM
ZAVRNJENA ZDRAVSTVENA TRDITEV
Algatrium® promotes your antioxidant response: a singular nutritional substance that has scientifically demonstrated in humans a stimulation of the own cells antioxidant defences
Algatrium® spodbuja vaš antioksidativni odziv: edina prehranska snov, ki znanstveno dokazano pri ljudeh spodbuja lastne celice antioksidativne obrambe.
Commission Regulation (EC) No 1169/2009
Uredba Komisije (ES) št. 1169/2009
amending Regulation (EC) No 353/2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council
o spremembi Uredbe (ES) št. 353/2008 o določitvi izvedbenih pravil za vloge za odobritev zdravstvenih trditev, kakor je predvideno v členu 15 Uredbe (ES) št. 1924/2006 Evropskega parlamenta in Sveta
Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods [1], and in particular Article 15(4) thereof,
ob upoštevanju Uredbe (ES) št. 1924/2006 Evropskega parlamenta in Sveta z dne 20. decembra 2006 o prehranskih in zdravstvenih trditvah na živilih [1] ter zlasti člena 15(4) Uredbe,
In order to ensure that for all categories of health claims made on foods, only health claims compliant with the general principles and the conditions set out in Regulation (EC) No 1924/2006 are submitted to the European Food Safety Authority (EFSA), hereinafter referred to as the Authority, and therefore subject to the authorisation procedure, it is necessary to lay down the conditions under which applications for authorisation of health claims may be considered valid and clarify the responsibility of the Member States in this respect in conformity with Article 15(2) and Article 18(3) of Regulation (EC) No 1924/2006.
Za zagotovitev, da se za vse vrste zdravstvenih trditev na živilih le dovoljene trditve na živilih, ki so skladne z glavnimi načeli in pogoji iz Uredbe (ES) št. 1924/2006, predložijo Evropski agenciji za varnost hrane – EFSA (v nadaljnjem besedilu: Agencija), kar pomeni, da zanje velja postopek odobritve, je treba določiti pogoje, pod katerimi se vloge za odobritev zdravstvenih trditev smejo šteti za veljavne, in pojasniti odgovornost držav članic v zvezi s tem v skladu s členom 15(2) in členom 18(3) Uredbe (ES) št. 1924/2006.
Pursuant to Article 20 of Regulation (EC) No 1924/2006 the list of authorised as well as rejected claims has to be published in a register for transparency reasons.
V skladu s členom 20 Uredbe (ES) št. 1924/2006 je treba zaradi preglednosti seznam odobrenih in zavrnjenih trditev objaviti v registru.
The purpose is, as explained in recital 31 of Regulation (EC) No 1924/2006, to avoid multiple applications in respect of claims which have already been assessed and subject to the authorisation procedure.
Kakor je pojasnjeno v uvodni izjavi 31 Uredbe (ES) št. 1924/2006, je namen preprečiti večkratne vloge v zvezi s trditvami, ki so bile že ocenjene in so predmet postopka odobritve.
Therefore, it is necessary to clarify among the modalities of presentation of an application, also the rules on withdrawals of applications as well as the time limits to submit a request for withdrawal.
Zato je treba v zvezi s pravili za predložitev vloge pojasniti tudi pravila za umaknitev vloge in roke za predložitev zahtevka za umaknitev.
The applicant should only be allowed to withdraw an application up to the moment the Authority adopts its opinion pursuant to Article 16(1) or Article 18(3) of Regulation (EC) No 1924/2006.
Vlagatelju mora biti umaknitev vloge dovoljena le do sprejetja mnenja Agencije v skladu s členom 16(1) ali 18(3) Uredbe (ES) št. 1924/2006.
Such time limit is necessary in order to preserve the usefulness of the Authority’s evaluation of claims and the effectiveness of the procedure for authorisation and rejection of claims and to avoid the submission of applications on claims which have already been assessed.
Takšen rok je potreben, da se ohrani uporabnost ocene trditev, ki jo naredi Agencija, učinkovitost postopka odobritve in zavrnitve trditev ter da se prepreči predložitev vlog v zvezi s trditvami, ki so že bile ocenjene.
In this respect, only withdrawals of applications submitted according to the conditions set out in the present Regulation can put an end to the authorisation procedure, which otherwise will continue after the Authority has issued its opinion.
Glede na to se lahko postopek odobritve, ki bi se sicer nadaljeval po sprejetju mnenja Agencije, konča z umaknitvijo vlog, predloženih v skladu s pogoji iz te uredbe.
Commission Regulation (EC) No 353/2008 [2] is amended as follows:1. the following Article 7a is inserted after Article 7:
Uredba Komisije (ES) št. 353/2008 [2] se spremeni:1. za členom 7 se doda člen 7a:
Verification of the validity of applications by the Member States
Preveritev veljavnosti vlog s strani držav članic
In accordance with Article 15(2)(a) and Article 18(3) of Regulation (EC) No 1924/2006, Member States shall verify the validity of applications before making them available to the Authority.
V skladu s členom 15(2)(a) in členom 18(3) Uredbe (ES) št. 1924/2006 države članice preverijo veljavnost vlog, preden jih dajo na voljo Agenciji.
For the purposes of paragraph 1, the national competent authority shall verify that applications submitted under Article 15 or 18 of Regulation (EC) No 1924/2006 include the data as referred to in Article 15(3) of that Regulation.
Za namene odstavka 1 pristojni nacionalni organ preveri, ali vloge, predložene v skladu s členom 15 ali 18 Uredbe (ES) št. 1924/2006, vključujejo podatke iz člena 15(3) navedene uredbe.
The national competent authority shall also verify that:
Pristojni nacionalni organ preveri:
for applications submitted under Article 15 of Regulation (EC) No 1924/2006 the health claim is a health claim concerning the reduction of disease risk claims or referring to children’s development and health;
ali se v vlogah, predloženih v skladu s členom 15 Uredbe (ES) št. 1924/2006, zdravstvena trditev nanaša na zmanjšanje tveganja za bolezen ali na razvoj in zdravje otrok;
for applications submitted under Article 18 of Regulation (EC) No 1924/2006 the health claim is any health claim as referred to in Article 13(5) of that Regulation with the exception of health claims referring to children’s development and health.’;
ali je v vlogah, predloženih v skladu s členom 18 Uredbe (ES) št. 1924/2006, zdravstvena trditev z izjemo zdravstvenih trditev, ki se nanašajo na razvoj in zdravje otrok, v skladu s členom 13(5) navedene uredbe.“;
the following Article 7b is inserted after Article 7a:
za členom 7a se doda člen 7b.
Withdrawal of applications
Umaknitev vlog
An application submitted under Article 15 or 18 of Regulation (EC) No 1924/2006 may be withdrawn by the applicant up to the moment the Authority adopts its opinion pursuant to Article 16(1) or Article 18(3) of Regulation (EC) No 1924/2006.
Vlagatelj lahko umakne vlogo, predloženo v skladu s členom 15 ali 18 Uredbe št. 1924/2006, do sprejetja mnenja Agencije v skladu s členom 16(1) ali členom 18(3) navedene Uredbe (ES) št. 1924/2006.
A request for withdrawal of an application must be submitted to the national competent authority of a Member State, to which the application was submitted in accordance with Article 15(2) or Article 18(2) of Regulation (EC) No 1924/2006.
Zahtevek za umaknitev vloge se mora predložiti pristojnemu nacionalnemu organu države članice, kateremu je bila predložena vloga v skladu s členom 15(2) ali členom 18(2) Uredbe (ES) št. 1924/2006.
The national competent authority shall, without delay, inform the Authority, the Commission and the other Member States of the withdrawal.
Nacionalni pristojni organ o umaknitvi takoj obvesti Agencijo, Komisijo in druge države članice.
Only the withdrawal of the application under the conditions mentioned in paragraph 1 and in this paragraph puts an end to the procedure.’.
Samo z umaknitvijo vloge pod pogoji iz odstavka 1 in tega odstavka se postopek konča.“
Commission Regulation (EC) No 1170/2009
Uredba Komisije (ES) št. 1170/2009
amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements
o spremembi Direktive 2002/46/ES Evropskega parlamenta in Sveta in Uredbe (ES) št. 1925/2006 Evropskega parlamenta in Sveta glede seznamov vitaminov in mineralov ter njihovih oblik, ki se lahko dodajo živilom, vključno s prehranskimi dopolnili
Having regard to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements [1], and in particular Article 4(5) thereof,
ob upoštevanju Direktive 2002/46/ES Evropskega parlamenta in Sveta z dne 10. junija 2002 o približevanju zakonodaj držav članic o prehranskih dopolnilih [1] in zlasti člena 4(5) Direktive,