natgillin/translations-raw huggingface dataset:
However, in the Authority’s responses of 4 August 2009 to comments received pursuant to Article 16(6) of Regulation (EC) No 1924/2006 and of 3 December 2009 to a request from the Commission for advice related, inter alia, to the applications referred to in Question No EFSA-Q-2008-675 and EFSA-Q-2008-773, it was concluded that as DHA is a major structural and functional long chain polyunsaturated fatty acid, it can contribute to the normal brain development and to the normal development of the eye of the foetus and breastfed infants.
Vendar je Agencija v odgovorih z dne 4. avgusta 2009 na pripombe, prejete v skladu s členom 16(6) Uredbe (ES) št. 1924/2006, in z dne 3. decembra 2009 na zahtevo Komisije za posvetovanje, med drugim glede vlog iz vprašanj št. EFSA-Q-2008-675 in EFSA-Q-2008-773, ugotovila, da DHA kot glavna strukturna in funkcionalna dolgoverižna večkrat nenasičena maščobna kislina lahko pomaga pri normalnem razvoju možganov ter oči pri fetusu in dojenčku, dojenem z materinim mlekom.
Further, it was clarified that most DHA is provided to breastfed infants via breast milk in which the DHA concentration is dependent both on maternal DHA dietary intake and on maternal DHA stores.
Poleg tega je bilo pojasnjeno, da dojeni dojenčki večino DHA dobijo z materinim mlekom, v katerem je koncentracija DHA odvisna od vnosa DHA prek materine prehrane in materine zaloge DHA.
Accordingly, health claims reflecting these conclusions and accompanied by specific conditions of use should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and they should be included in the Union list of permitted claims.
Zdravstvene trditve, ki odražajo te ugotovitve in so jim priloženi posebni pogoji uporabe, je zato treba šteti za skladne z zahtevami iz Uredbe (ES) št. 1924/2006 ter jih uvrstiti na seznam dovoljenih trditev Unije.
Accordingly, those particulars should be set out in the Annex to the present Regulation as regards the authorised claim and include, as the case may be, the revised wording of the claim, specific conditions of use of the claim, and, where applicable, conditions or restrictions of use of the food and/or an additional statement or warning, in accordance with the rules laid down in Regulation (EC) No 1924/2006 and in line with the opinions of the Authority.
Navedene podatke v zvezi z odobreno trditvijo je treba določiti v Prilogi k tej uredbi ter vanje vključiti, odvisno od primera, spremenjeno besedilo trditve, posebne pogoje uporabe trditve in, kadar je to ustrezno, pogoje ali omejitve uporabe živila in/ali dodatno pojasnilo ali opozorilo v skladu s pravili iz Uredbe (ES) št. 1924/2006 in mnenji Agencije.
Therefore, where the wording of claims has the same meaning for consumers as that of an authorised health claim, because they demonstrate the same relationship that exists between a food category, a food or one of its constituents and health, they should be subject to the same conditions of use indicated in the Annex to this Regulation.
Kadar ima besedilo trditev za potrošnike enak pomen kot odobrena zdravstvena trditev, ker predstavljata isto povezavo med kategorijo živila, živilom ali njegovo sestavino in zdravjem, je treba te trditve uporabljati pod istimi pogoji, kot so navedeni v Prilogi k tej uredbi.
Following three applications from Mead Johnson & Company, submitted on 19 January 2008 pursuant to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Authority was required to deliver three opinions on health claims related to the effects of DHA and ARA on brain development (Question No EFSA-Q-2008-212 [9], EFSA-Q-2008-690 [10] and EFSA-Q-2008-691 [11]).
Družba Mead Johnson & Company je 19. januarja 2008 v skladu s členom 14(1)(b) Uredbe (ES) št. 1924/2006 vložila tri vloge, Agencija pa je morala pripraviti tri mnenja o zdravstveni trditvi v zvezi z vplivi DHA in ARA na razvoj možganov (vprašanja št. EFSA-Q-2008-212 [9], EFSA-Q-2008-690 [10] in EFSA-Q-2008-691 [11]).
The claims proposed by the applicant were worded, respectively, as follows: ‘DHA and ARA contribute to the optimal brain development of infants and young children’, ‘Lipil® contributes to optimal brain development of infants and young children’ and ‘Enfamil® Premium contributes to optimal brain development of infants and young children’.
Vlagatelj je predlagal naslednje trditve: „DHA in ARA pomagata pri optimalnem razvoju možganov pri dojenčkih in malih otrocih“, „Lipil® pomaga pri optimalnem razvoju možganov pri dojenčkih in malih otrocih“ in „Enfamil® Premium pomaga pri optimalnem razvoju možganov pri dojenčkih in malih otrocih“.
Lipil® and Enfamil® Premium as stated by the applicant contain DHA and ARA at specific levels and ratio.
Vlagatelj navaja, da Lipil® in Enfamil® Premium vsebujeta določen delež DHA in ARA v specifičnem razmerju.
On the basis of the data submitted, the Authority concluded in its opinions received by the Commission on 23 March 2009 that there was insufficient evidence to establish a cause and effect relationship between the consumption of DHA and ARA, Lipil® and Enfamil® Premium, respectively, and the claimed effect.
Agencija je v svojih mnenjih, ki jih je Komisija prejela 23. marca 2009, na podlagi predloženih podatkov sklenila, da ni bilo zadostnih dokazov za utemeljitev vzročno-posledične povezave med uživanjem DHA in ARA, Lipila® in Enfamila® Premium ter navedenimi trditvami.
In the Authority’s responses of 3 September 2009 to comments received pursuant to Article 16(6) of Regulation (EC) No 1924/2006 and of 3 December 2009 to the request of the Commission for advice relating, inter alia, to the applications referred to in Question No EFSA-Q-2008-690, EFSA-Q-2008-691 and EFSA-Q-2008-212, it was concluded that as DHA is a major structural and functional long chain polyunsaturated fatty acid, it can contribute to the normal brain development of the foetus, infants and young children.
Vendar je Agencija v odgovorih z dne 3. septembra 2009 na pripombe, prejete v skladu s členom 16(6) Uredbe (ES) št. 1924/2006, in z dne 3. decembra 2009 na zahtevo Komisije za posvetovanje, med drugim glede vlog iz vprašanj št. EFSA-Q-2008-690, EFSA-Q-2008-691 in EFSA-Q-2008-212, ugotovila, da DHA kot glavna strukturna in funkcionalna dolgoverižna večkrat nenasičena maščobna kislina lahko pomaga pri normalnem razvoju možganov pri fetusih, dojenčkih in malih otrocih.
Therefore, the Commission and the Member States considered whether a health claim reflecting this conclusion should be authorised.
Zato so Komisija in države članice proučile, ali je treba zdravstveno trditev, ki odraža to ugotovitev, odobriti.
However, on the basis of the data submitted in the three applications and of the current scientific knowledge, the Authority could not provide specific advice on the appropriate conditions of use that should accompany this health claim.
Vendar Agencija na podlagi predloženih podatkov v treh vlogah in trenutnih znanstvenih spoznanj ni mogla zagotoviti posebnih nasvetov o ustreznih pogojih uporabe, ki morajo biti priloženi tej zdravstveni trditvi.
Accordingly, as risk managers could not establish specific conditions of use in accordance with Article 16(4) of the Regulation (EC) No 1924/2006, and given that the lack of such specific conditions of use means that the beneficial effect of the product could not be assured, which amounts to misleading the consumer, this health claim should not be included in the lists of permitted health claims.
Ker odgovorni za oceno tveganj niso mogli vzpostaviti posebnih pogojev uporabe v skladu s členom 16(4) Uredbe (ES) št. 1924/2006 in ker brez takih posebnih pogojev uporabe ni mogoče zagotoviti koristnih učinkov proizvoda, kar posledično pomeni zavajanje potrošnika, se ta zdravstvena trditev ne sme vključiti na seznam dovoljenih zdravstvenih trditev.
The Commission took also into account all relevant advice from the Authority, including opinions on labelling reference intake values for n-3 and n-6 polyunsaturated fatty acids (Question No EFSA-Q-2009-00548 [12]) and on dietary reference values for fat including saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, trans-fatty acids, and cholesterol (Question No EFSA-Q-2008-466 [13]).
Komisija je upoštevala tudi vse ustrezne nasvete Agencije, vključno z mnenji o označevanju referenčnih vrednosti za vnos n-3 in n-6 večkrat nenasičenih maščobnih kislin (vprašanje št. EFSA-Q-2009-00548 [12]) in o referenčnih vrednostih za vnos maščob, vključno z nasičenimi maščobnimi kislinami, večkrat nenasičenimi maščobnimi kislinami, enkrat nenasičenimi maščobnimi kislinami, trans maščobnimi kislinami in holesterolom (vprašanje št. EFSA-Q-2008-466 [13]).
The health claims listed in Annex I to this Regulation may be made on foods on the European Union market in compliance with the conditions laid down in that Annex.
Zdravstvene trditve iz Priloge I k tej uredbi se lahko navedejo na živilih na trgu Evropske unije v skladu s pogoji iz navedene priloge.
The health claims referred to in paragraph 1 shall be included in the Union list of permitted claims referred to in Article 14(1) of Regulation (EC) No 1924/2006.
Zdravstvene trditve iz odstavka 1 se vključijo na seznam dovoljenih trditev Unije iz člena 14(1) Uredbe (ES) št. 1924/2006.
The health claims listed in Annex II 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.
Zdravstvene trditve iz Priloge II k tej uredbi se ne uvrstijo na seznam dovoljenih trditev Unije v skladu s členom 14(1) Uredbe (ES) št. 1924/2006.
However, they may continue to be used for 6 months after the entry into force of this Regulation.
Vendar se navedene zdravstvene trditve lahko uporabljajo še šest mesecev po začetku veljavnosti te uredbe.
The EFSA Journal (2009), 1003, 1-8.
The EFSA Journal (2009), 1003, str. 1–8.
The EFSA Journal (2009), 941, 1-14.
The EFSA Journal (2009), 941, str. 1–14.
The EFSA Journal (2009), 1004, 1-8.
The EFSA Journal (2009), 1004, str. 1–8.
The EFSA Journal (2009), 1006, 1-12.
The EFSA Journal (2009), 1006, str. 1–12.
The EFSA Journal (2009), 1007, 1-14.
The EFSA Journal (2009), 1007, str. 1–14.
The EFSA Journal (2009), 1000, 1-13.
The EFSA Journal (2009), 1000, str. 1–13.
The EFSA Journal (2009) 1001, 1-8.
The EFSA Journal (2009) 1001, str. 1–8.
The EFSA Journal (2009) 1002, 1-8.
The EFSA Journal (2009) 1002, str. 1–8.
The EFSA Journal (2009), 1176, 1-11.
The EFSA Journal (2009), 1176, str. 1–11.
Permitted health claims
Dovoljene zdravstvene trditve
Applicant – Address
Vlagatelj – naslov
Docosahexaenoic acid (DHA)
dokozaheksaenojska kislina (DHA)
Docosahexaenoic acid (DHA) intake contributes to the normal visual development of infants up to 12 months of age.
Vnos dokozaheksaenojske kisline (DHA) pomaga pri normalnem razvoju vida pri dojenčkih do 12. meseca starosti.
Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 100 mg of DHA.
Potrošnike se obvesti, da se koristni učinek doseže z dnevnim vnosom 100 mg DHA.
When the claim is used on follow-on formula, the food shall contain at least 0,3 % of the total fatty acids as DHA.
Kadar se trditev uporablja na nadaljevalni formuli, živilo vsebuje vsaj 0,3 % vseh maščobnih kislin v obliki DHA.
Docosahexaenoic acid (DHA) maternal intake contributes to the normal development of the eye of the foetus and breastfed infants.
Vnos dokozaheksaenojske kisline (DHA) prek matere pomaga pri normalnem razvoju oči pri fetusu in dojenčku, dojenem z materinim mlekom.
Information shall be given to pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition to the recommended daily intake for omega-3 fatty acids for adults, i.e. 250 mg DHA and eicosapentaenoic acid (EPA).
Nosečnice in doječe matere se obvesti, da se koristni učinek doseže z dnevnim vnosom 200 mg DHA poleg priporočenega dnevnega vnosa omega-3 maščobnih kislin za odrasle, tj. 250 mg DHA in eikozapentaenojske kisline (EPA).
The claim can be used only for food which provides a daily intake of at least 200 mg DHA.
Trditev se lahko uporablja le za živila, ki zagotavljajo dnevni vnos vsaj 200 mg DHA.
Docosahexaenoic acid (DHA) maternal intake contributes to the normal brain development of the foetus and breastfed infants.
Vnos dokozaheksaenojske kisline (DHA) prek matere pomaga pri normalnem razvoju možganov pri fetusu in dojenčku, dojenem z materinim mlekom.
Information shall be given to pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition to the recommended daily intake for omega-3 fatty acids for adults, i.e. 250 mg DHA and EPA.
Nosečnice in doječe matere se obvesti, da se koristni učinek doseže z dnevnim vnosom 200 mg DHA poleg priporočenega dnevnega vnosa omega-3 maščobnih kislin za odrasle, tj. 250 mg DHA in EPA.
Docosahexaenoic acid (DHA) and arachidonic acid (ARA)
dokozaheksaenojska kislina (DHA) in arahidonska kislina (ARA)
Docosahexaenoic acid (DHA) and arachidonic acid (ARA) contribute to the optimal brain development of infants and young children.
Dokozaheksaenojska kislina (DHA) in arahidonska kislina (ARA) pomagata pri optimalnem razvoju možganov pri dojenčkih in malih otrocih.
Lipil® contributes to optimal brain development of infants and young children.
Lipil® pomaga pri optimalnem razvoju možganov pri dojenčkih in malih otrocih.
Enfamil® Premium contributes to optimal brain development of infants and young children.
Enfamil® Premium pomaga pri optimalnem razvoju možganov pri dojenčkih in malih otrocih.
In the Authority’s responses of 3 September 2009 to comments received pursuant to Article 16(6) of Regulation (EC) No 1924/2006 and of 3 December 2009 to the request of the Commission for advice relating, inter alia, to the applications referred to in Question No EFSA-Q-2008-211, EFSA-Q-2008-688 and EFSA-Q-2008-689, it was concluded that the claimed effect could be extended to foods intended to infants while they are being weaned, as defined in Commission Directive 2006/125/EC [5].
Agencija je v odgovorih z dne 3. septembra 2009 na pripombe, prejete v skladu s členom 16(6) Uredbe (ES) št. 1924/2006, in z dne 3. decembra 2009 na zahtevo Komisije za posvetovanje, med drugim glede vlog iz vprašanj št. EFSA-Q-2008-211, EFSA-Q-2008-688 in EFSA-Q-2008-689, ugotovila, da bi lahko navedeno trditev razširili na živila, namenjena dojenčkom, pri katerih se zaključuje dojenje, kot določa Direktiva Komisije 2006/125/ES [5].
Accordingly and without prejudice to Directive 2009/39/EC of the European Parliament and of the Council [6] and specific Directives applicable to certain groups of foodstuffs for particular nutritional uses, a health claim reflecting this conclusion and accompanied by specific conditions of use should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and it should be included in the Union list of permitted claims.
Brez poseganja v Direktivo 2009/39/ES Evropskega parlamenta in Sveta [6] ter posebne direktive, ki se nanašajo na nekatere skupine živil za posebne prehranske namene, je zato zdravstveno trditev, ki odraža to ugotovitev in so ji priloženi posebni pogoji uporabe, treba šteti za skladno z zahtevami iz Uredbe (ES) št. 1924/2006 ter jo uvrstiti na seznam dovoljenih trditev Unije.
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 6 months after the adoption of this Regulation, provided an application was made before 19 January 2008.
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, če je bila vloga vložena pred 19. januarjem 2008.
Accordingly, the transition period laid down in that Article is applicable to health claims listed in Annex II to this Regulation.
Prehodno obdobje iz istega člena se nanaša na zdravstvene trditve iz Priloge II k tej uredbi.
Mead Johnson & Company, 3 rue Joseph Monier-BP 325, 92506 Rueil-Malmaison Cedex, France
Mead Johnson & Company, 3 rue Joseph Monier-BP 325, 92506 Rueil-Malmaison Cedex, Francija
Merck Selbstmedikation GmbH, Roesslerstrasse 96, 64293 Darmstadt, Germany
Merck Selbstmedikation GmbH, Roesslerstrasse 96, 64293 Darmstadt, Nemčija
Commission Implementing Regulation (EU) No 441/2011
Izvedbena uredba Komisije (EU) št. 441/2011
This Regulation shall enter into force on 7 May 2011.
Ta uredba začne veljati 7. maja 2011.
Council Regulation (EU) No 442/2011
Uredba Sveta (EU) št. 442/2011
concerning restrictive measures in view of the situation in Syria
o omejevalnih ukrepih glede na razmere v Siriji
Having regard to Council Decision 2011/273/CFSP of 9 May 2011 concerning restrictive measures against Syria [1], adopted in accordance with Chapter 2 of Title V of the Treaty on European Union,
ob upoštevanju Sklepa Sveta 2011/273/SZVP z dne 9. maja 2011 o omejevalnih ukrepih proti Siriji [1], sprejetega v skladu s poglavjem 2 naslova V Pogodbe o Evropski uniji,
Decision 2011/273/CFSP provides for an arms embargo, a ban on internal repression equipment, and restrictions on the admission to the Union, and the freezing of funds and economic resources, of certain persons and entities responsible for the violent repression against the civilian population in Syria.
Sklep 2011/273/SZVP vzpostavlja embargo na orožje, prepoved izvoza opreme za notranjo represijo ter omejitve glede sprejemanja v Unijo določenih oseb in subjektov, odgovornih za nasilno zatiranje civilnega prebivalstva v Siriji, ter zamrznitev sredstev in gospodarskih virov tem osebam in subjektom.
Those persons, entities and bodies are listed in the Annex to that Decision.
Te osebe, subjekti in organi so navedeni v Prilogi k navedenemu sklepu.
Some of those measures fall within the scope of the Treaty on the Functioning of the European Union and regulatory action at the level of the Union is therefore necessary in order to implement them, in particular with a view to ensuring their uniform application by economic operators in all Member States.
Nekateri od teh ukrepov spadajo v področje uporabe Pogodbe o delovanju Evropske unije, zato je regulativni ukrep na ravni Unije potreben za njihovo izvajanje, predvsem z namenom zagotovitve, da jih bodo gospodarski subjekti v vseh državah članicah enotno izvajali.
This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and, in particular, the right to an effective remedy and to a fair trial and the right to the protection of personal data.
S to uredbo se spoštujejo temeljne pravice in upoštevajo načela, ki so priznana zlasti v Listini Evropske unije o temeljnih pravicah, ter zlasti pravica do učinkovitega pravnega sredstva in poštenega sojenja ter pravica do varstva osebnih podatkov.
This Regulation should be applied in accordance with those rights.
Ta uredba bi se morala uporabljati v skladu s temi pravicami.
The power to amend the list in Annex II to this Regulation should be exercised by the Council, in view of the serious political situation in Syria, and to ensure consistency with the process for amending and reviewing the Annex to Decision 2011/273/CFSP.
Zaradi resnosti političnih razmer v Siriji ter zaradi zagotovitve skladnosti s postopkom za spremembo in pregled Priloge k Sklepu 2011/273/SZVP bi moral pooblastilo za spremembo seznama iz Priloge II k tej uredbi imeti Svet.
The procedure for amending the lists in Annex II to this Regulation should include providing designated natural or legal persons, entities or bodies with the grounds for listing, so as to give them an opportunity to submit observations.
Postopek za spremembo seznamov iz Priloge II k tej uredbi bi moral vključevati posredovanje vključenim fizičnim ali pravnim osebam, subjektom ali organom razloge za uvrstitev na seznam, da bi jim dali možnost, da predložijo pripombe.
Where observations are submitted, or substantial new evidence is presented, the Council should review its decision in light of those observations and inform the person, entity or body concerned accordingly.
Če so predložene pripombe ali novi tehtni dokazi bi moral Svet glede na te pripombe ponovno preučiti svoj sklep in o tem ustrezno obvestiti zadevno osebo, subjekt ali organ.
For the implementation of this Regulation, and in order to create maximum legal certainty within the Union, the names and other relevant data concerning natural and legal persons, entities and bodies whose funds and economic resources must be frozen in accordance with this Regulation, must be made public.Any processing of personal data should comply with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data [2] and Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [3].
Za izvajanje te uredbe in za zagotovitev čim večje pravne varnosti v Uniji morajo biti javno objavljena imena in drugi ustrezni podatki v zvezi s fizičnimi in pravnimi osebami, subjekti in organi, katerih sredstva in gospodarski viri se morajo biti v skladu s to uredbo zamrzniti. Vsakršna obdelava osebnih podatkov bi morala biti usklajena z Uredbo (ES) št. 45/2001 Evropskega parlamenta in Sveta z dne 18. decembra 2000 o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah in organih Skupnosti in o prostem pretoku takih podatkov [2] ter Direktivo 95/46/ES Evropskega parlamenta in Sveta z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov [3].
In order to ensure that the measures provided for in this Regulation are effective, this Regulation should enter into force on the day of its publication,
Da se zagotovi učinkovitost ukrepov iz te uredbe, bi morala ta uredba začeti veljati takoj –
deposits with financial institutions or other entities, balances on accounts, debts and debt obligations;
depozite pri finančnih institucijah ali drugih subjektih, stanja na računih, dolgove in zadolžnice;
‘freezing of funds’ means preventing any move, transfer, alteration, use of, access to, or dealing with funds in any way that would result in any change in their volume, amount, location, ownership, possession, character, destination or other change that would enable the funds to be used, including portfolio management;
„zamrznitev sredstev“ pomeni preprečitev vsakršnega premika, prenosa, spremembe, uporabe sredstev, dostopa do njih ali kakršnega koli ravnanja z njimi, ki bi imelo za posledico spremembe v njihovi količini, znesku, lokaciji, lastništvu, posedovanju, vrsti, namembnosti ali druge spremembe, ki bi omogočile uporabo sredstev, vključno z upravljanjem premoženja;
‘economic resources’ means assets of every kind, whether tangible or intangible, movable or immovable, which are not funds but may be used to obtain funds, goods or services;
„gospodarski viri“ pomenijo vse vrste sredstev, opredmetena ali neopredmetena, premična ali nepremična, ki sicer niso sredstva, se pa lahko uporabijo za pridobitev sredstev, blaga ali storitev;
‘technical assistance’ means any technical support related to repairs, development, manufacture, assembly, testing, maintenance, or any other technical service, and may take forms such as instruction, advice, training, the transmission of working knowledge or skills or consulting services; including verbal forms of assistance;
„tehnična pomoč“ pomeni vsako tehnično podporo pri popravilih, razvoju, proizvodnji, sestavljanju, preizkušanju, vzdrževanju ali drugih tehničnih storitvah in je lahko v obliki navodil, svetovanja, usposabljanja, prenosa praktičnega znanja ali spretnosti ali svetovalnih storitev; vključuje tudi ustne oblike pomoči;