natgillin/translations-raw huggingface dataset:
On 26 September 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 Femilub® and the claimed effect.
Komisija in države članice so 26. septembra 2012 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem Femilub® 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 a combination of lycopene, vitamin E, lutein and selenium and protection of the skin from UV-induced damage (Question No EFSA-Q-2012-00592) [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 učinki mešanice likopena, vitamina E, luteina in selena na zaščito kože pred škodo, nastalo zaradi UV-žarkov (vprašanje št. EFSA-Q-2012-00592) [16].
The claim proposed by the applicant was worded, inter alia, as follows: ‘Helps to prepare sensitive skin from the inside to improve their tolerance to the sun’.
Vložnik je med drugim predlagal naslednjo trditev: „Pomaga pripraviti občutljivo kožo, da od znotraj izboljša odpornost na sonce“.
On 27 September 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 lycopene, vitamin E, lutein and selenium and the claimed effect.
Komisija in države članice so 27. septembra 2012 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledična povezava med uživanjem mešanice likopena, vitamina E, luteina in selena ter navedeno trditvijo ni utemeljena.
Following an application from Glanbia Nutritionals plc, 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 Prolibra® and ‘Helps to reduce body fat while preserving lean muscle’ (Question No EFSA-Q-2012-00001) [17].
Družba Glanbia Nutritionals plc 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 učinki Prolibra® in „Pomaga zmanjšati telesno maščobo in obenem ohranja mišično maso“ (vprašanje št. EFSA-Q-2012-00001) [17].
The claim proposed by the applicant was worded as follows: ‘Helps to reduce body fat while preserving lean muscle’.
Vložnik je predlagal naslednjo trditev: „Pomaga zmanjšati telesno maščobo in obenem ohranja mišično maso.“
On 8 November 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 could not be established between the consumption of Prolibra® and the claimed effect.
Komisija in države članice so 8. novembra 2012 prejele znanstveno mnenje Agencije, ki je na podlagi predloženih podatkov ugotovila, da vzročno-posledične povezave med uživanjem Prolibra® in navedeno trditvijo ni bilo mogoče utemeljiti.
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 ‘Helps to support joint function by maintaining low levels of plasma C-reactive protein’ (Question No EFSA-Q-2012-00386) [18].
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 učinki EffEXT™ in „Pomaga pri presnovi v sklepih z vzdrževanjem nizkih ravni C-reaktivnega proteina v plazmi“ (vprašanje št. EFSA-Q-2012-00386) [18].
The claim proposed by the applicant was worded, inter alia, as follows: ‘Helps to support joint function by maintaining low levels of plasma C-reactive protein’.
Vložnik je med drugim predlagal naslednjo trditev: „Pomaga pri presnovi v sklepih z vzdrževanjem nizkih ravni C-reaktivnega proteina v plazmi“.
On 27 September 2012, the Commission and the Member States received the scientific opinion from the Authority, which noted that the claim refers to a reduction of inflammation indicated by a lowered concentration of plasma C-reactive protein and concluded that on the basis of the data presented, a reduction of inflammation in the context of diseases such as osteoarthritis or rheumatoid arthritis is a therapeutic target for the treatment of a disease.
Komisija in države članice so 27. septembra 2012 prejele znanstveno mnenje Agencije, ki je zapisala, da se trditev nanaša na zmanjšanje vnetja, ki jo pokaže znižana koncentracija C-reaktivnega proteina v plazmi, in na podlagi predloženih podatkov ugotovila, da je zmanjšanje vnetja terapevtski cilj pri zdravljenju bolezni, kot sta osteoartritis ali revmatoidni artritis.
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 [19].
Uredba (ES) št. 1924/2006 dopolnjuje splošne določbe Direktive 2000/13/ES Evropskega parlamenta in Sveta z dne 20. marca 2000 o približevanju zakonodaje držav članic o označevanju, predstavljanju in oglaševanju živil [19].
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 opozarjati na take lastnosti.
Accordingly, as the attribution of medicinal properties to foods is prohibited, the claim related to the effects of EffEXT™ should not be authorised.
Ker je pripisovanje zdravilnih lastnosti živilom prepovedano, se trditev o učinkih EffEXT™ ne bi smela odobriti.
The health claim related to the effects of EffEXT™ and ‘Helps to support joint function by maintaining low levels of plasma C-reactive protein’, is a health claim attributing medicinal properties to the food subject to the claim and is therefore prohibited for foods.
Zdravstvena trditev v zvezi z učinki EffEXT™ in „Pomaga pri presnovi v sklepih z vzdrževanjem nizkih ravni C-reaktivnega proteina v plazmi“ je zdravstvena trditev, ki pripisuje zdravilne lastnosti živilom, za katera velja trditev, in je zato prepovedana za živila.
The health claim related to Prolibra® and ‘Helps to reduce body fat while preserving lean muscle’ is a health claim as those referred to in point (c) of Article 13(1) of Regulation (EC) No 1924/2006 which are subject to the transitional period laid down in Article 28(6) of that Regulation.
Zdravstvena trditev v zvezi s Prolibra® in „Pomaga zmanjšati telesno maščobo in obenem ohranja mišično maso“ je zdravstvena trditev iz člena 13(1)(c) Uredbe (ES) št. 1924/2006, zato zanjo velja prehodno obdobje iz člena 28(6) navedene uredbe.
However, as the application was not made before 19 January 2008, the requirement provided for in point (b) of Article 28(6) of that Regulation is not fulfilled, and therefore this claim may not benefit from the transitional period provided for in that Article.
Ker pa vloga ni bila predložena pred 19. januarjem 2008, zahteva iz točke (b) člena 28(6) navedene uredbe ni izpolnjena, zato se prehodno obdobje iz navedenega člena za to trditev ne more uporabiti.
The other health claims subject to this Regulation are health claims as referred to in point (a) of Article 13(1) of Regulation (EC) No 1924/2006, which are subject to the transitional period laid down in Article 28(5) of that Regulation until the adoption of the list of permitted health claims provided that they comply with that Regulation.
Druge zdravstvene trditve, ki so predmet te uredbe, so zdravstvene trditve iz točke (a) člena 13(1) Uredbe (ES) št. 1924/2006, za katere do sprejetja seznama dovoljenih zdravstvenih trditev velja prehodno obdobje iz člena 28(5) navedene uredbe, pod pogojem, da so te v skladu z navedeno uredbo.
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 vložniki in predstavniki javnosti poslali Komisiji v skladu s členom 16(6) Uredbe (ES) št. 1924/2006.
Glucosamine
glukozamin
Glucosamine contributes to the protection of joint cartilage exposed to excessive motion or loading and helps to improve the range of motion in joints
Glukozamin prispeva k zaščiti sklepnega hrustanca, izpostavljenega prekomernemu gibanju ali obremenitvi, in pomaga izboljšati obseg premikanja sklepov
Glucosamine contributes to the maintenance of normal joint cartilage
Glukozamin prispeva k ohranjanju normalnega sklepnega hrustanca
Wheat polar lipid extract
izvleček polarnega lipida iz pšenice
Contributes to improve skin hydration
Prispeva k izboljšanju hidracije kože
Saccharomyces cerevisiae var. boulardii CNCM I-3799 helps maintain intestinal comfort
Saccharomyces cerevisiae var. boulardii CNCM I-3799 pomaga vzdrževati črevesno udobje
A combination of thiamin, riboflavin, niacin, pantothenic acid, pyridoxine, D-biotin and pumpkin seed oil (Cucurbita pepo L.)
mešanica tiamina, riboflavina, niacina, pantotenske kisline, piridoksina, D-biotina in bučnega olja (Cucurbita pepo L.)
Helps to increase hair number
Pomaga povečati število las
Rhodiola rosea L. extract
izvleček Rhodiola rosea L.
Helps to reduce tiredness in case of stress
Pomaga zmanjšati utrujenost v primeru stresa
A combination of flaxseed oil and vitamin E
mešanica lanenega olja in vitamina E
Contributes to maintain skin permeability barrier function
Prispeva k ohranjanju pregradne funkcije prepustnosti kože
OptiEFAX™ helps to maintain healthy blood levels of LDL cholesterol
OptiEFAX™ pomaga vzdrževati zdrave ravni LDL-holesterola v krvi
OptiEFAX™ helps to maintain healthy blood levels of HDL cholesterol
OptiEFAX™ pomaga vzdrževati zdrave ravni HDL-holesterola v krvi
Helps to maintain hair strength
Pomaga ohraniti močne lase
Hyaluronic acid
hialuronska kislina
Helps to maintain good skin hydration
Pomaga ohraniti dobro hidracijo kože
OptiEFAX™ helps to maintain healthy blood levels of triglycerides
OptiEFAX™ pomaga vzdrževati zdrave ravni trigliceridov v krvi
Improves transit and durably regulates it
Izboljša prehajanje črevesne vsebine in ga trajno ureja
Helps to reduce vaginal dryness
Pomaga zmanjšati vaginalno suhost
A combination of lycopene, vitamin E, lutein and selenium
mešanica likopena, vitamina E, luteina in selena
Helps to prepare sensitive skin from the inside to improve their tolerance to the sun
Pomaga pripraviti občutljivo kožo, da od znotraj izboljša odpornost na sonce
Helps to reduce body fat while preserving lean muscle
Pomaga zmanjšati telesno maščobo in obenem ohranja mišično maso
Helps to support joint function by maintaining low levels of plasma C-reactive protein
Pomaga pri presnovi v sklepih z vzdrževanjem nizkih ravni C-reaktivnega proteina v plazmi
The list of permitted health claims has been established by Commission Regulation (EU) No 432/2012 [20] and is applicable since 14 December 2012.
Seznam dovoljenih zdravstvenih trditev je bil določen z Uredbo Komisije (EU) št. 432/2012 [20] in se uporablja od 14. decembra 2012.
As regards claims referred to in Article 13(5) of Regulation (EC) No 1924/2006 for which the evaluation by the Authority or consideration by the Commission has not been completed by 14 December 2012 and which by virtue of this Regulation are not included in the list of permitted health claims, it is appropriate to provide for a transitional period during which they may still be used, in order to allow both food business operators and the competent national authorities to adapt to the prohibition of such claims.
Glede trditev iz člena 13(5) Uredbe (ES) št. 1924/2006, za katere ocena agencije ali presoja Komisije ni bila zaključena do 14. decembra 2012 in katere na podlagi te uredbe niso vključene v seznam dovoljenih zdravstvenih trditev, je primerno predvideti prehodno obdobje, v katerem se še vedno lahko uporabljajo, da se nosilci živilske dejavnosti in nacionalni pristojni organi lahko prilagodijo prepovedi takih trditev.
Q-2012-00334 & Q-2012-00335
Q-2012-00334 in Q-2012-00335
Commission Regulation (EU) No 1067/2013
Uredba Komisije (EU) št. 1067/2013
amending Regulation (EC) No 1881/2006 as regards maximum levels of the contaminants dioxins, dioxin-like PCBs and non-dioxin-like PCBs in liver of terrestrial animals
o spremembi Uredbe (ES) št. 1881/2006 glede mejnih vrednosti onesnaževal, tj. dioksinov, dioksinom podobnih PCB in dioksinom nepodobnih PCB, v jetrih kopenskih živali
Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs [2] sets maximum levels for dioxins and dioxin-like polychlorinated biphenyls (PCBs) in a range of foodstuffs, including in the liver of certain terrestrial animals.
Uredba Komisije (ES) št. 1881/2006 z dne 19. decembra 2006 o določitvi mejnih vrednosti nekaterih onesnaževal v živilih [2] določa mejne vrednosti dioksinov in dioksinom podobnih polikloriranih bifenilov (PCB) v izboru živil, vključno v jetrih nekaterih kopenskih živali.
The Scientific Panel on Contaminants in the Food Chain (The Panel) of the European Food Safety Authority (EFSA) has, on a request from the Commission, adopted on 5 July 2011 an opinion on the risk to public health related to the presence of high levels of dioxins and dioxin-like PCBs in liver from sheep and deer [3].
Znanstveni odbor za onesnaževala v prehranjevalni verigi (odbor) Evropske agencije za varnost hrane (EFSA) je 5. julija 2011 na zahtevo Komisije sprejel mnenje o tveganju za javno zdravje, ki je povezano s prisotnostjo visokih vrednosti dioksinov in dioksinom podobnih PCB v jetrih ovac in jelenov [3].
The Commission requested that the opinion should indicate whether there is a potential increase in consumer health risk for subgroups of the population consuming such products (e.g. high consumers, people following specific diets, etc.).
Komisija je zahtevala, da je treba v mnenju navesti, ali obstaja možnost povečanja tveganja za zdravje podskupin prebivalstva, ki uživajo take proizvode (npr. pogosti uživalci ali ljudje s posebnimi dietami itn.).
The opinion should also explore possible reasons for the findings of high levels of dioxins and PCBs in sheep and deer liver, and to provide scientific elements on the appropriateness to establish in future regulatory levels in liver on a product basis rather than on a fat basis.
Mnenje bi moralo proučiti tudi možne razloge za ugotovitev visokih vrednosti dioksinov in PCB v jetrih ovac in jelenov ter zagotoviti znanstvena spoznanja o primernosti, da se zakonsko določene ravni v jetrih v prihodnje določijo na podlagi proizvodov in ne maščob.
The Panel concluded that regular consumption of sheep liver would result on average in an approximate 20 % increase of the background exposure to dioxins and dioxin-like PCBs.
Zato je odbor sklenil, da bi redno uživanje ovčjih jeter v povprečju pomenilo približno 20-odstotno povečanje osnovne izpostavljenosti dioksinom in dioksinom podobnim PCB.
On individual occasions, consumption of sheep liver could result in high intakes exceeding the tolerable weekly intake (TWI) of those contaminants.
V posameznih primerih ima lahko uživanje ovčjih jeter za posledico visoke vnose, ki presegajo sprejemljiv tedenski vnos (TWI – tolerable weekly intake) teh onesnaževal.
The Panel concluded that the frequent consumption of sheep liver, particularly by women of child-bearing age and children, may be a potential health concern.
Odbor je ugotovil, da je pogosto uživanje ovčjih jeter lahko škodljivo za zdravje, zlasti če jih uživajo ženske v rodni dobi in otroci.
The Panel further concluded that soil and sediments are natural reservoirs of dioxins and PCBs.
Odbor je nadalje sklenil, da so prst in sedimenti naravni zbiralniki dioksinov in PCB.
Soil-to-plant transfer of dioxins and PCBs via the root apparatus is generally of minor importance.
Prenos dioksinov in PCB iz prsti v rastline prek korenin je v glavnem manjšega pomena.
In the past few years a number of sheep liver samples from various European countries were found to contain high concentrations of dioxins and PCBs although not being associated with specific contamination sources.
V zadnjih nekaj letih je bilo za številne vzorce ovčjih jeter iz različnih evropskih držav ugotovljeno, da vsebujejo visoke koncentracije dioksinov in PCB, čeprav niso bili povezani s specifičnimi viri onesnaževanja.
For sheep, grazing activity is a primary factor for exposure.
Za ovce je paša glavni dejavnik izpostavljenosti.
When grazing, intake of soil can occur through particles deposited on vegetables or directly when feeding on pasture herbage close to ground surface.
Med pašo lahko vnos prsti poteka prek delcev, odloženih na zelenjavi, ali neposredno pri krmljenju na pašniku blizu površine tal.
Soil intake is remarkably variable and strongly seasonal: a median soil intake has been reported in the order of 8 % of dry matter intake.
Vnos prsti je izredno spremenljiv in izrazito sezonsko pogojen: po poročanju naj bi mediana vnosa prsti znašala 8 % vnosa suhe snovi.
On the whole, soil intake might contribute substantially to sheep’s exposure to dioxins and PCBs.
Na splošno lahko vnos prsti bistveno prispeva k izpostavljenosti ovc dioksinom in PCB.
Limited data are available concerning the transfer of dioxins and/or PCBs from feed to sheep liver.
Na voljo so le omejeni podatki o prenosu dioksinov in/ali PCB s krme v ovčja jetra.
Depending on the polychlorinated dibenzo-p-dioxin (PCDD), polychlorinated dibenzofuran (PCDF) or PCB congeners considered, reported transfer ratios varied from 5 to 175 and were approximately four times higher for liver than for meat or kidney.
Poročana razmerja prenosa so bila od 5 do 175, odvisno od polikloriranih dibenzo-p-dioksinov (PCDD), polikloriranih dibenzofuranov (PCDF) ali kongenerov PCB, in so bila štirikrat večja za jetra kot za meso ali ledvice.
EFSA concluded also that sheep liver is an important storage organ of dioxins and PCBs.
EFSA je sklenila tudi, da so jetra ovac pomemben organ za skladiščenje dioksinov in PCB.
The differences in metabolism could partly explain the relatively high liver storage of dioxins and related compounds in sheep compared to cattle.
Razlike v presnovi bi lahko delno pojasnile sorazmerno visoko skladiščenje dioksinov in sorodnih sestavin v jetrih ovac v primerjavi z govedom.
EFSA concluded that even if there would be a possible hepatic sequestration and the dioxins and PCBs would not be totally associated with the fat fraction of the liver, this would have no influence on the result, whether expressed on lipid or fresh weight basis, as all dioxins and PCBs are extracted during the analytical procedure irrespective of the liver compartment where they are present.
EFSA je zaključila, da tudi v primeru, če bi bila možna sekvestracija v jetrih ter dioksini in PCB ne bi bili v celoti povezani z maščobno frakcijo jeter, to ne bi vplivalo na rezultat, ne glede na to, ali je izražen na podlagi lipidov ali sveže teže, saj so med analitskim postopkom ekstrahirani vsi dioksini in PCB ne glede na to, kje se nahajajo v jetrih.
The European Union Reference Laboratory (EURL) for dioxins and PCBs in Feed and Food was requested by the Commission to investigate how different extraction methods influence the levels of dioxins and PCBs in sheep liver with regard to reporting the analytical result on fat or wet weight basis.
Komisija je zaprosila referenčni laboratorij Evropske unije (v nadaljnjem besedilu: EURL) za dioksine in PCB v krmi in živilih, da razišče, kako različne metode ekstrakcije vplivajo na ravni dioksinov in PCB v jetrih ovac glede poročanja analitičnih rezultatov na podlagi maščobe ali mokre teže.
The EURL concluded that the variations for concentrations of dioxins and PCBs were considerably higher on fat basis compared to wet weight basis.
EURL je sklenil, da so bila odstopanja koncentracij dioksinov in PCB znatno višja na podlagi maščobe v primerjavi z mokro težo.
The concentrations of dioxins and PCBs on fat basis in sheep liver were dependant on the applied extraction method or solvents and therefore on the resulting fat content.
Koncentracije dioksinov in PCB na podlagi maščobe v ovčjih jetrih so odvisne od uporabljene metode ekstrakcije ali topil in tako od posledične vsebnosti maščobe.
When comparing results on wet weight, the levels of dioxins and PCBs were quite comparable.
Pri primerjavi rezultatov mokre teže so bile ravni dioksinov in PCB dokaj primerljive.
Therefore in order to ensure comparable results and an uniform enforcement approach across the Union as regards dioxins and PCBs in liver of terrestrial animals, it is appropriate to establish the maximum levels on a wet weight basis as was already established for fish liver and derived products thereof.
Zato je primerno določiti mejne vrednosti na podlagi mokre teže, kot je že bilo ugotovljeno za ribja jetra in proizvode iz njih, da se zagotovijo primerljivi rezultati in enakomeren pristop izvajanja v zvezi z dioksini in PCB v jetrih kopenskih živali v Uniji.
It is appropriate to provide that the maximum levels are not applicable to foodstuffs which are lawfully placed on the market before the date of application.
Določiti je treba, da se mejne vrednosti ne uporabljajo za živila, ki so zakonito dana v promet pred dnevom začetka uporabe.
In the Annex to Regulation (EC) No 1881/2006, point 5.2 is replaced by the following:
V Prilogi k Uredbi (ES) št. 1881/2006 se točka 5.2 nadomesti z naslednjim:
Liver of terrestrial animals referred to in 5.1 with the exception of sheep and derived products thereof
jetra kopenskih živali iz točke 5.1, razen ovčjih jeter, in proizvodi iz njih
3,0 ng/g wet weight
3,0 ng/g mokre teže
Liver of sheep and derived products thereof
ovčja jetra in proizvodi iz njih
1,25 pg/g wet weight
1,25 pg/g mokre teže
2,00 pg/g wet weight
2,00 pg/g mokre teže
3,0 ng/g wet weight’
3,0 ng/g mokre teže“
This Regulation shall not apply to products which were placed on the market at a date prior to 1 January 2014 in conformity with the provisions applicable at such date.
Ta uredba se ne uporablja za proizvode, ki so bili dani v promet pred 1. januarjem 2014 v skladu z določbami, ki se uporabljajo na ta dan.
The burden of proving when the products were placed on the market shall be borne by the food business operator.
Breme dokazovanja, kdaj so bili proizvodi dani v promet, nosi nosilec živilske dejavnosti.
EFSA Panel on Contaminants in the Food Chain (Contam); Scientific Opinion on the risk to public health related to the presence of high levels of dioxins and dioxin-like PCBs in liver from sheep and deer.
Odbor EFSA za onesnaževala v prehranski verigi (Contam); Znanstveno mnenje o tveganju za javno zdravje, povezano s prisotnostjo visokih vrednosti dioksinov in dioksinom podobnih PCB v jetrih ovac in jelenov.
Commission Regulation (EU) No 1068/2013
Uredba Komisije (EU) št. 1068/2013
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of diphosphates (E 450), triphosphates (E 451) and polyphosphates (E 452) in wet salted fish
o spremembi Priloge II k Uredbi (ES) št. 1333/2008 Evropskega parlamenta in Sveta glede uporabe difosfatov (E 450), trifosfatov (E 451) in polifosfatov(E 452) pri pripravi mokro nasoljene ribe