natgillin/translations-raw huggingface dataset:
the protection of honey bees, non-target arthropods, earthworms and non-target micro- and macro-organisms.
zaščito čebel, neciljnih členonožcev, deževnikov ter neciljnih mikroorganizmov in makroorganizmov.
the plant metabolism and consumer exposure;
metabolizmu rastline in izpostavljenosti potrošnikov;
the toxicity of the compounds that constitute the extract and the relevance of possible impurities other than methyl eugenol;
toksičnosti spojin, ki sestavljajo ekstrakt, in relevantnosti morebitnih nečistoč, z izjemo metil evgenola;
the groundwater exposure for the less strongly absorbed components that constitute the extract and for potential soil transformation products;
izpostavljenosti podtalnice v zvezi s sestavinami ekstrakta, ki se absorbirajo manj intenzivno, in v zvezi z morebitnimi proizvodi za spremembo tal;
the effects on biological methods of sewage treatment.
učinkih na biološke metode v postopkih čiščenja odpadnih vod.
The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016 at latest.’
Prijavitelj Komisiji, državam članicam in Agenciji navedene informacije predloži najpozneje do 30. aprila 2016.“
Commission Regulation (EU) No 155/2014
Uredba Komisije (EU) št. 155/2014
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 18(5) 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] in zlasti člena 18(5) Uredbe,
The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’ for a scientific assessment, as well as to the Commission and the Member States for information.
Pristojni nacionalni organ veljavne vloge pošlje Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija) za pripravo znanstvene ocene ter Komisiji in državam članicam v vednost.
Following an application from Vitabiotics Ltd, 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 the effects of L-tyrosine and contribution to normal synthesis of dopamine (Question No EFSA-Q-2011-00319) [2].
Družba Vitabiotics Ltd. je 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 vplivi L-tirozina in njegovim prispevkom k normalni sintezi dopamina (vprašanje št. EFSA-Q-2011-00319) [2].
The claim proposed by the applicant was worded as follows: ‘L-tyrosine is essential for the natural formation of dopamine’.
Vlagatelj je predlagal naslednjo trditev: „L-tirozin je bistven za naravno nastajanje dopamina.“
On 20 July 2011, the Commission and the Member States received the scientific opinion from the Authority, which noted that the role of L-tyrosine in the normal synthesis of catecholamines for the general population has already been addressed with a favourable outcome in a previous opinion [3] in the context of evaluation of claims referred to in Article 13(1) of Regulation (EC) No 1924/2006 and that L-tyrosine is the starting point for the synthesis of all catecholamines, including dopamine.
Komisija in države članice so 20. julija 2011 prejele znanstveno mnenje Agencije, ki je ugotovila, da je vlogo L-tirozina pri normalni sintezi kateholaminov za splošno prebivalstvo v okviru ocenjevanja trditev iz člena 13(1) Uredbe (ES) št. 1924/2006 že obravnavala s pozitivnim izidom v enem od prejšnjih mnenj [3] in da je L-tirozin izhodiščna točka za sintezo vseh kateholaminov, vključno z dopaminom.
Thus, the Authority concluded that a cause and effect relationship had been established between the consumption of L-tyrosine in a protein adequate diet and contribution to normal synthesis of dopamine and proposed as appropriate conditions of use that ‘a food should be at least a source of protein as per Annex to Regulation (EC) No 1924/2006’.
Na podlagi tega je Agencija ugotovila, da obstaja vzročno-posledična povezava med uživanjem L-tirozina v okviru beljakovinsko ustrezne prehrane in prispevanjem k normalni sintezi dopamina, ter kot primeren pogoj uporabe zdravstvene trditve predlagala, da bi moralo biti „živilo vsaj takšen vir beljakovin, kot je določeno v Prilogi k Uredbi (ES) št. 1924/2006“.
The Commission and the Member States have considered whether the health claim reflecting those conclusions should be authorised under the proposed conditions of use, since authorisation may also legitimately be withheld if health claims do not comply with other general and specific requirements of Regulation (EC) No 1924/2006, even in the case of a favourable scientific assessment by the Authority.
Komisija in države članice so presojale, ali bi bilo treba pod predlaganim pogojem uporabe odobriti zdravstveno trditev, ki odraža navedeno ugotovitev, saj se odobritev lahko upravičeno zadrži tudi pri pozitivni znanstveni oceni Agencije, če zdravstvene trditve ne izpolnjujejo drugih splošnih in posebnih zahtev iz Uredbe (ES) št. 1924/2006.
In the Authority’s response of 9 November 2012 to the request of the Commission, inter alia, for clarification in relation to the evidence submitted for the health claim on L-tyrosine and the proposed conditions of use, the Authority noted that its conclusions for this claim were based on the well established biochemical role of L-tyrosine, as contained in protein.
Agencija je v odgovoru z dne 9. novembra 2012 na zahtevo Komisije, med drugim za pojasnila glede dokazov, predloženih za zdravstveno trditev o L-tirozinu, in predlaganega pogoja uporabe, navedla, da njene ugotovitve o tej trditvi temeljijo na dobro uveljavljeni biokemijski vlogi L-tirozina v beljakovinah.
It added that, on the basis of the evidence submitted, it could not provide a quantitative indication of the necessary daily intake of L-tyrosine per se to produce the beneficial physiological effect.
Dodala je, da na podlagi predloženih dokazov ni mogla kvantitativno oceniti potrebnega dnevnega vnosa samega L-tirozina za zagotovitev ugodnega fiziološkega učinka.
Therefore, it is not possible to establish specific conditions for the use of this claim to ensure that L-tyrosine is contained in the final product in a quantity that will produce the beneficial physiological effect in accordance with point (i) of Article 5(1)(b) of Regulation (EC) No 1924/2006.
Zato za navedeno trditev ni mogoče določiti posebnih pogojev uporabe, da bi zagotovili, da končni izdelek vsebuje dovolj L-tirozina za ugoden fiziološki učinek v skladu s točko (i) člena 5(1)(b) Uredbe (ES) št. 1924/2006.
In the absence of such specific conditions of use, the beneficial effect of the substance to which the claim relates cannot be assured and thus this claim could be misleading to the consumer.
Brez takšnih posebnih pogojev uporabe ni mogoče zagotoviti ugodnega učinka snovi, ki ga navaja trditev, zato bi bila ta lahko zavajajoča za potrošnike.
Following an application from Pierre Fabre Dermo-Cosmétique, 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 the consumption of iron and maintenance of normal hair growth (Question No EFSA-Q-2012-00059) [4].
Družba Pierre Fabre Dermo-Cosmétique je 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 uživanjem železa in ohranjanjem normalne rasti las (vprašanje št. EFSA-Q-2012-00059) [4].
The claim proposed by the applicant was worded as follows: ‘Excessive hair loss in non-menopausal women’.
Vlagatelj je predlagal naslednjo trditev: „Zmanjšanje čezmernega izpadanja las pri ženskah, ki niso v menopavzi.“
On 15 March 2012, 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 intake of iron and maintenance of normal hair growth.
Komisija in države članice so 15. marca 2012 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem železa in ohranjanjem normalne rasti las ni utemeljena.
Following an application from Biocodex, 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 the consumption of citrulline-malate and faster recovery from muscle fatigue after exercise (Question No EFSA-Q-2011-00931) [5].
Družba Biocodex je 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 uživanjem citrulin malata in hitrejšim okrevanjem pri mišični utrujenosti po telesni dejavnosti (vprašanje št. EFSA-Q-2011-00931) [5].
The claim proposed by the applicant was worded as follows: ‘Maintenance of adenosine triphosphate (ATP) levels through reduction of lactates in excess for recovery from muscle fatigue’.
Vlagatelj je predlagal naslednjo trditev: „Ohranjanje ravni adenozin-trifosfata (ATP) z zmanjšanjem presežka laktatov za okrevanje pri mišični utrujenosti.“
On 11 May 2012, 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 citrulline-malate and the claimed effect.
Komisija in države članice so 11. maja 2012 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem citrulin malata in navedeno trditvijo ni utemeljena.
Following an application from Nutrilinks Sarl, 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 the effects of EffEXT™ and maintenance of normal joint mobility (Question No EFSA-Q-2012-00384) [6].
Družba Nutrilinks Sarl je 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 vplivi EffEXT™ in ohranjanjem normalne gibljivosti sklepov (vprašanje št. EFSA-Q-2012-00384) [6].
The claim proposed by the applicant was worded, inter alia, as follows: ‘Contributes to support joint flexibility’.
Vlagatelj je med drugim predlagal naslednjo trditev: „Prispeva h gibljivosti sklepov.“
On 14 December 2012, 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 EffEXT™ and the claimed effect.
Komisija in države članice so 14. decembra 2012 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem EffEXT™ in navedeno trditvijo ni utemeljena.
Following an application from Nutrilinks Sarl, 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 the effects of krill oil and maintenance of joint comfort (Question No EFSA-Q-2012-00385) [7].
Družba Nutrilinks Sarl je 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 vplivi krilovega olja in lajšanjem težav s sklepi (vprašanje št. EFSA-Q-2012-00385) [7].
The claim proposed by the applicant was worded, inter alia, as follows: ‘Helps to improve the comfort of sensitive joints’.
Vlagatelj je med drugim predlagal naslednjo trditev: „Pomaga pri lajšanju težav z občutljivimi sklepi.“
On 14 December 2012, 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 krill oil and the claimed effect.
Komisija in države članice so 14. decembra 2012 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem krilovega olja in navedeno trditvijo ni utemeljena.
Following an application from Nutrilinks Sarl, 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 the effects of Vitis vinifera L. seeds extract and normal venous blood flow (Question No EFSA-Q-2012-00387) [8].
Družba Nutrilinks Sarl je 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 vplivi izvlečka iz semen Vitis vinifera L. in normalnim venoznim pretokom krvi (vprašanje št. EFSA-Q-2012-00387) [8].
The claim proposed by the applicant was worded, inter alia, as follows: ‘Contributes to promote venous circulation in the legs’.
Vlagatelj je med drugim predlagal naslednjo trditev: „Prispeva k izboljšanju venoznega pretoka krvi v nogah.“
On 14 December 2012, 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 Vitis vinifera L. seeds extract and the claimed effect.
Komisija in države članice so 14. decembra 2012 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem izvlečka iz semen Vitis vinifera L. in navedeno trditvijo ni utemeljena.
Following an application from Nutrilinks Sarl, 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 the effects of Vitis vinifera L. seeds extract and ‘Helps to decrease swollen legs’ (Question No EFSA-Q-2012-00388) [9].
Družba Nutrilinks Sarl je 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 vplivi izvlečka iz semen Vitis vinifera L. in trditvijo „Pomaga pri zmanjševanju oteklin nog.“ (vprašanje št. EFSA-Q-2012-00388) [9].
The claim proposed by the applicant was worded, inter alia, as follows: ‘Helps to decrease swollen legs’.
Vlagatelj je med drugim predlagal naslednjo trditev: „Pomaga pri zmanjševanju oteklin nog.“
On 14 December 2012, the Commission and the Member States received the scientific opinion from the Authority, which noted that the claim refers to the reduction of peripheral oedema in the context of chronic clinical conditions (e.g. chronic venous insufficiency) and concluded that on the basis of the data presented, such reduction of peripheral oedema in the context of chronic clinical conditions is a therapeutic target for their treatment.
Komisija in države članice so 14. decembra 2012 prejele znanstveno mnenje Agencije, ki je ugotovila, da se ta trditev nanaša na zmanjšanje perifernih edemov pri kroničnih kliničnih stanjih (npr. kronični venski insuficienci) in da je na podlagi predloženih podatkov takšno zmanjšanje perifernih edemov pri kroničnih kliničnih stanjih terapevtski cilj njihovega zdravljenja.
Regulation (EC) No 1924/2006 complements the general principles of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs [10].
Uredba (ES) št. 1924/2006 dopolnjuje splošna načela Direktive 2000/13/ES Evropskega parlamenta in Sveta z dne 20. marca 2000 o približevanju zakonodaje držav članic o označevanju, predstavljanju in oglaševanju živil [10].
Article 2(1)(b) of Directive 2000/13/EC provides that the labelling shall not attribute to any foodstuff the property of preventing, treating or curing a human disease, or refer to such properties.
Člen 2(1)(b) Direktive 2000/13/ES določa, da označevanje živilom ne sme pripisovati lastnosti, kot so preprečevanje, zdravljenje ali ozdravljenje bolezni pri ljudeh, ali nanje opozarjati.
Accordingly, as the attribution of medicinal properties to foods is prohibited, the claim related to the effects of Vitis vinifera L. seeds extract and ‘Helps to decrease swollen legs’ should not be authorised.
Ker je pripisovanje zdravilnih lastnosti živilom prepovedano, se zdravstvena trditev v zvezi z vplivi izvlečka iz semen Vitis vinifera L. in trditvijo „Pomaga pri zmanjševanju oteklin nog.“ ne bi smela odobriti.
Following an application from Roxlor Nutra LLC, 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 the effects of Cynatine® and maintenance of normal joint mobility (Question No EFSA-Q-2012-00570) [11].
Družba Roxlor Nutra LLC je 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 vplivi Cynatine® in ohranjanjem normalne gibljivosti sklepov (vprašanje št. EFSA-Q-2012-00570) [11].
The claim proposed by the applicant was worded, inter alia, as follows: ‘Daily consumption of 500 mg of Cynatine® helps to support joint flexibility’.
Vlagatelj je med drugim predlagal naslednjo trditev: „Dnevno uživanje 500 mg Cynatine® prispeva h gibljivosti sklepov.“
On 14 December 2012, 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 Cynatine® and the claimed effect.
Komisija in države članice so 14. decembra 2012 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem Cynatine® in navedeno trditvijo ni utemeljena.
Following an application from Actina, 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 the effects of OXY 280 and reduction of body weight (Question No EFSA-Q-2012-00572) [12].
Družba Actina je 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 vplivi OXY 280 in zmanjšanjem telesne teže (vprašanje št. EFSA-Q-2012-00572) [12].
The claim proposed by the applicant was worded, inter alia, as follows: ‘OXY 280 helps to lose weight’.
Vlagatelj je med drugim predlagal naslednjo trditev: „OXY 280 prispeva k zmanjšanju teže.“
On 14 December 2012, 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 OXY 280 and the claimed effect.
Komisija in države članice so 14. decembra 2012 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem OXY 280 in navedeno trditvijo ni utemeljena.
Following an application from Nutrilinks Sarl, 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 the effects of Vitis vinifera L. seeds extract and ‘Helps to drain the body in case of water accumulation’ (Question No EFSA-Q-2012-00574) [13].
Družba Nutrilinks Sarl je 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 vplivi izvlečka iz semen Vitis vinifera L. in trditvijo „Pomaga izločati odvečno vodo iz telesa.“ (vprašanje št. EFSA-Q-2012-00574) [13].
The claim proposed by the applicant was worded, inter alia, as follows: ‘Helps to drain the body in case of water accumulation’.
Vlagatelj je med drugim predlagal naslednjo trditev: „Pomaga izločati odvečno vodo iz telesa.“
On 14 December 2012, the Commission and the Member States received the scientific opinion from the Authority, which noted that the claimed effect refers to the maintenance of normal venous blood flow.
Komisija in države članice so 14. decembra 2012 prejele znanstveno mnenje Agencije, ki je ugotovila, da se trditev nanaša na ohranjanje normalnega venoznega pretoka krvi.
The Authority noted also that the same health relationship was already subject to its assessment in a previous opinion [14] with an unfavourable outcome and that the reference provided for the scientific substantiation of this claim was already considered in the previous opinion.
Agencija je ugotovila tudi, da je to zdravstveno povezavo že obravnavala z negativnim izidom v enem od prejšnjih mnenj [14] in da je bila znanstvena utemeljitev te trditve že obravnavana v njem.
Following an application from Nutrilinks Sarl, 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 the effects of a combination of Paullinia cupana Kunth (guarana) and Camellia sinensis (L.) Kuntze (green tea) extracts and reduction of body weight (Question No EFSA-Q-2012-00590) [15].
Družba Nutrilinks Sarl je 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 vplivi kombinacije izvlečkov iz Paullinia cupana Kunth (gvarane) in Camellia sinensis (L.) Kuntze (zelenega čaja) ter zmanjšanjem telesne teže (vprašanje št. EFSA-Q-2012-00590) [15].
The claim proposed by the applicant was worded, inter alia, as follows: ‘Helps to burn fat’.
Vlagatelj je med drugim predlagal naslednjo trditev: „Pomaga topiti telesno maščobo.“
On 14 December 2012, 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 a combination of Paullinia cupana Kunth (guarana) and Camellia sinensis (L.) Kuntze (green tea) extracts and the claimed effect.
Komisija in države članice so 14. decembra 2012 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem kombinacije izvlečkov iz Paullinia cupana Kunth (gvarane) in Camellia sinensis (L.) Kuntze (zelenega čaja) ter navedeno trditvijo ni utemeljena.
Following an application from Nutrilinks Sarl, 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 the effects of a combination of lycopene, vitamin E, lutein and selenium and ‘Helps to prepare and activate tanning’ (Question No EFSA-Q-2012-00593) [16].
Družba Nutrilinks Sarl je 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 vplivi kombinacije likopena, vitamina E, luteina in selena ter trditvijo „Pomaga aktivirati porjavitev in kožo pripraviti nanjo.“ (vprašanje št. EFSA-Q-2012-00593) [16].
The claim proposed by the applicant was worded, inter alia, as follows: ‘Helps to prepare and activate tanning’.
Vlagatelj je med drugim predlagal naslednjo trditev: „Pomaga aktivirati porjavitev in kožo pripraviti nanjo.“
On 14 December 2012, the Commission and the Member States received the scientific opinion from the Authority, which noted that the claimed effect refers to increasing the pigmentation of the skin (i.e. tanning) which may contribute to the protection of the skin against UV-induced damage.
Komisija in države članice so 14. decembra 2012 prejele znanstveno mnenje Agencije, ki je ugotovila, da se trditev nanaša na povečanje pigmentacije kože (tj. porjavitev), ki lahko prispeva k zaščiti kože pred škodo, ki jo povzroča ultravijolično sevanje.