natgillin/translations-raw huggingface dataset:
Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients [1], and in particular Article 7 thereof,
ob upoštevanju Uredbe (ES) št. 258/97 Evropskega parlamenta in Sveta z dne 27. januarja 1997 v zvezi z novimi živili in novimi živilskimi sestavinami [1], zlasti člena 7 Uredbe,
On 1 June 2004, the company DSM Nutritional Products VML made a request to the competent authorities of the Netherlands to place synthetic zeaxanthin on the market as a novel food ingredient.
Družba DSM Nutritional Products VML je 1. junija 2004 vložila zahtevek pri pristojnih organih Nizozemske za dajanje sintetičnega zeaksantina na trg kot nove živilske sestavine.
On 16 June 2005 the competent food assessment body of the Netherlands issued its initial assessment report.
Pristojni organ Nizozemske za presojo živil je 16. junija 2005 izdal poročilo o začetni presoji.
In that report it came to the conclusion that synthetic zeaxanthin with a maximum intake for not more than 20 mg per person per day, would not present a significant risk for human health.
V njem je navedel, da sintetični zeaksantin, kadar največji dnevni vnos ne presega 20 mg na osebo, ne predstavlja pomembnega tveganja za zdravje ljudi.
However, it concluded that the data presented were not sufficient to complete the safety assessment.
Vendar je ugotovil, da predloženi podatki ne zadoščajo za zaključek presoje varnosti.
Therefore an additional assessment was required.
Zato je bila potrebna dodatna presoja.
The Commission forwarded the initial assessment report to all Member States on 1 August 2005 for additional comments.
Komisija je 1. avgusta 2005 poslala poročilo o začetni presoji vsem državam članicam za dodatna pojasnila.
On 2 February 2007 the applicant informed the Commission that the use of zeaxanthin should be limited to be used only as an ingredient in food supplements.
Vlagatelj je 2. februarja 2007 obvestil Komisijo, da bi bilo treba uporabo zeaksantina omejiti samo na uporabo kot živilska sestavina prehranskih dopolnil.
The Commission consulted the European Food Safety Authority (EFSA) on 20 March 2007.
Komisija se je 20. marca 2007 posvetovala z Evropsko agencijo za varnost hrane (EFSA).
On 24 April 2008 the EFSA adopted a Scientific Opinion on the safety of ‘synthetic zeaxanthin as an ingredient in food supplements’ [2] concluding that based on the existing data, the safety of synthetic zeaxanthin as an ingredient in food supplements at the proposed level of 20 mg per person per day has not been established.
EFSA je 24. aprila 2008 sprejela znanstveno mnenje o varnosti „sintetičnega zeaksantina kot sestavine prehranskih dopolnil“ [2], v katerem je sklenila, da na podlagi obstoječih podatkov ni potrjena varnost sintetičnega zeaksantina kot sestavine prehranskih dopolnil pri predlagani ravni 20 mg na osebo na dan.
On 25 January 2012 the applicant provided additional information and proposed an intake of synthetic zeaxanthin as an ingredient in food supplements of up to 2 mg per person per day.
Vlagatelj je 25. januarja 2012 predložil dodatne informacije in predlagal vnos sintetičnega zeaksantina kot sestavine prehranskih dopolnil v odmerku 2 mg na osebo na dan.
Following a request from the Commission, EFSA was asked to update its opinion on the safety of synthetic zeaxanthin as a novel food ingredient in food supplements in the light of the additional information.
Komisija je glede na dodatne informacije agencijo EFSA zaprosila za posodobitev mnenja o varnosti sintetičnega zeaksantina kot nove živilske sestavine prehranskih dopolnil.
On 13 September 2012, EFSA adopted a ‘Statement on the safety of synthetic zeaxanthin as an ingredient in food supplements’ [3] concluding that the use level proposed by the applicant does not raise safety concerns.
EFSA je 13. septembra 2012 sprejela „izjavo o varnosti sintetičnega zeaksantina kot sestavine prehranskih dopolnil“ [3], v kateri je ugotovila, da raven uporabe, ki jo je predlagal vlagatelj, ne vzbuja pomislekov glede varnosti.
On the basis of the scientific assessment, it is established that synthetic zeaxanthin complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
Na podlagi znanstvene ocene se sklene, da sintetični zeaksantin izpolnjuje merila iz člena 3(1) Uredbe (ES) št. 258/97.
The intentional addition of synthetic zeaxanthin to food for colouring purposes falls within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives [4] and should be authorised in accordance with that Regulation.
Namensko dodajanje sintetičnega zeaksantina živilom za namene obarvanja spada v področje uporabe Uredbe (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila [4] in bi ga bilo treba v skladu z navedeno uredbo odobriti.
Synthetic zeaxanthin as specified in the Annex may be placed on the market in the Union as a novel food ingredient in food supplements at the maximum intake recommended by the manufacturer of up to 2 mg per day.
Sintetični zeaksantin, kot je opredeljen v Prilogi, se lahko da na trg Unije kot nova živilska sestavina pri največjem priporočenem vnosu, ki ga priporoča proizvajalec in znaša 2 mg na dan.
The designation of synthetic zeaxanthin authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘synthetic zeaxanthin’.
Oznaka sintetičnega zeaksantina, odobrenega s tem sklepom, na živilih, ki ga vsebujejo, je „sintetični zeaksantin“.
This Decision is addressed to DSM Nutritional Products, Alexander Fleminglaan 1, 2613 AX Delft, The Netherlands
Ta sklep je naslovljen na družbo DSM Nutritional Products, Alexander Fleminglaan 1, 2613 AX Delft, Nizozemska
EFSA Journal (2008) 728, 1-27.
EFSA Journal (2008) 728, str. 1–27.
SPECIFICATIONS OF SYNTHETIC ZEAXANTHIN
SPECIFIKACIJE SINTETIČNEGA ZEAKSANTINA
Definition Zeaxanthin is a naturally occurring xanthophyll pigment, it is an oxygenated carotenoid.
Opredelitev Zeaksantin je naravno prisotni ksantofilni pigment in oksigenirani karotenoid.
Synthetic zeaxanthin is produced by a multi-step chemical synthesis from smaller molecules.
Sintetični zeaksantin se proizvaja z večstopenjsko kemično sintezo iz manjših molekul.
Synthetic zeaxanthin is presented either as a spray-dried powder of gelatin or starch base (‘beadlets’) with added α-tocopherol and ascorbyl palmitate or as a corn oil suspension with added α-tocopherol
Sintetični zeaksantin je v obliki (z razprševanjem) posušenega prahu na želatinski ali škrobni podlagi („kapljice“) z dodanim α-tokoferolom in askorbilpalmitatom, ali v obliki suspenzije s koruznim oljem z dodanim α-tokoferolom.
Description: Orange-red crystalline powder with little or no odour
Opis: oranžnordeč kristalinični prah s šibkim vonjem ali brez vonja
CAS No: 144-68-3
Št. CAS: 144-68-3
Molecular weight: 568,9 daltons
Molekulska masa: 568,9 daltonov
Physical-chemical properties of synthetic zeaxanthin Loss on drying
Fizikalno-kemijske lastnosti sintetičnega zeaksantina Izguba pri sušenju
All-trans zeaxanthin
All-trans zeaksantin
more than 96 %
več kot 96 %
Cis-zeaxanthin
Cis-zeaksantin
Triphenylphosphine oxid
Trifenilfosfin oksid
less than 50 mg/kg
manj kot 50 mg/kg
authorising an extension of use of Chia (Salvia hispanica) seed as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
o odobritvi razširitve uporabe semena oljne kadulje (Salvia hispanica) kot nove živilske sestavine v skladu z Uredbo (ES) št. 258/97 Evropskega parlamenta in Sveta
(notified under document C(2013) 123)
(notificirano pod dokumentarno številko C(2013) 123)
Commission Decision 2009/827/EC [2] authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of Chia (Salvia hispanica) seed as a novel food ingredient to be used in bread products with a maximum content of 5 % Chia (Salvia hispanica) seeds.
Z Odločbo Komisije 2009/827/ES [2] je bilo v skladu z Uredbo (ES) št. 258/97 odobreno dajanje na trg semena oljne kadulje (Salvia hispanica) kot nove živilske sestavine za uporabo v kruhu z največjo vsebnostjo 5 % semen oljne kadulje (Salvia hispanica).
On 14 April 2011 The Chia Company made a request to the competent authorities of the United Kingdom for an extension of use of Chia seed on the market as a novel food ingredient.
Družba Chia Company je 14. aprila 2011 pri pristojnih organih Združenega kraljestva vložila zahtevek za razširitev uporabe semena oljne kadulje kot nove živilske sestavine.
In particular, they asked to use up to 10 % Chia seed in certain food categories and to sell pre-packed Chia seed with a recommended daily intake of up to 15 g.
Zaprosila je zlasti za odobritev uporabe do 10 % semen oljne kadulje v nekaterih kategorijah živil in prodajo predpakiranih semen oljne kadulje s priporočljivim dnevnim vnosom do 15 g.
On 16 March 2012, the competent food assessment body of the United Kingdom issued its initial assessment report.
Pristojni organ Združenega kraljestva za presojo živil je 16. marca 2012 izdal poročilo o začetni presoji.
In that report it came to the conclusion that extending the use of Chia seeds for the proposed food categories meets the criteria set out in Article 3(1) of Regulation (EC) No 258/97.
V navedenem poročilu je ugotovil, da je razširitev uporab semen oljne kadulje za predlagane kategorije živil skladna z merili iz člena 3(1) Uredbe (ES) št. 258/97.
On 26 March 2012, the Commission forwarded the initial assessment report to all Member States.
Komisija je 26. marca 2012 poročilo o začetni presoji poslala vsem državam članicam.
Reasoned objections were raised within the 60-day period laid down in the second subparagraph of Article 6(4) of Regulation (EC) No 258/97, in particular concerning the possible lack of toxicological data.
V roku 60 dni, ki je določen v drugem pododstavku člena 6(4) Uredbe (ES) št. 258/97, so bili vloženi upravičeni ugovori, zlasti glede morebitnih manjkajočih toksikoloških podatkov.
Additional explanations by the applicant alleviated these concerns to the satisfaction of the Member States and the Commission.
Dodatna pojasnila vlagatelja so zadovoljivo odpravila zaskrbljenost držav članic in Komisije.
Therefore it was confirmed that the criteria set out in Article 3(1) of Regulation (EC) No 258/97 are fulfilled.
Zato je bilo potrjeno, da je merilom iz člena 3(1) Uredbe (ES) št. 258/97 zadoščeno.
Pursuant to Article 7(1) of Regulation (EC) No 258/97 an Implementing Decision should be adopted to authorise an extension of use of Chia seed as a novel food ingredient.
V skladu s členom 7(1) Uredbe (ES) št. 258/97 bi bilo treba sprejeti izvedbeni sklep za odobritev razširitve uporabe semen oljne kadulje kot nove živilske sestavine.
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the food chain and Animal Health,
Ukrepi, predvideni s tem sklepom, so v skladu z mnenjem Stalnega odbora za prehranjevalno verigo in zdravje živali –
Chia (Salvia hispanica) seed as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the uses listed in Annex II.
Seme oljne kadulje (Salvia hispanica), kot je opredeljeno v Prilogi I, se lahko daje na trg Unije kot nova živilska sestavina za uporabe iz Priloge II.
Chia (Salvia hispanica) seed as such may be sold to the final consumer in a pre-packaged form only.
Seme oljne kadulje (Salvia hispanica) se lahko končnemu potrošniku prodaja samo v predpakirani obliki.
The designation of Chia (Salvia hispanica) seed authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘Chia (Salvia hispanica) seeds’.
Oznaka semena oljne kadulje (Salvia hispanica), odobrenega s tem sklepom, na embalaži živil je „semena oljne kadulje (Salvia hispanica)“.
Additional labelling of pre-packaged Chia (Salvia hispanica) seed is required to inform the consumer that the daily intake is no more than 15 g.
Potrebno je dodatno označevanje semen oljne kadulje (Salvia hispanica) v predpakirani obliki, s katerim se potrošnika obvešča, da je dnevni vnos največ 15 g.
This Decision is addressed to The Chia Company, 262-276 Lorimer Street, Port Melbourne, VIC 3207 Australia
Ta sklep je naslovljen na družbo The Chia Company, 262-276 Lorimer Street, Port Melbourne, VIC 3207 Avstralija
OJ L 294, 11.11.2009, p. 14.
UL L 294, 11.11.2009, str. 14.
SPECIFICATIONS OF CHIA (SALVIA HISPANICA) SEED
SPECIFIKACIJE SEMENA OLJNE KADULJE (SALVIA HISPANICA)
Chia (Salvia hispanica) is a summer annual herbaceous plant belonging to the Labiatae family.
Oljna kadulja (Salvia hispanica) je zeliščna poletna enoletnica, ki spada v družino Labiatae.
Typical Composition of Chia Seed
Značilna sestava semena oljne kadulje
Dietary fibre (Crude Fibre [1])
Prehranske vlaknine (surova vlakna [1])
Crude fibre is the part of fibre made mainly of indigestible cellulose, pentosans and lignin.
Surova vlakna so del vlaknin, ki so sestavljena pretežno iz neprebavljive celuloze, pentozanov in lignina.
USES OF CHIA (SALVIA HISPANICA) SEED
UPORABE SEMENA OLJNE KADULJE (SALVIA HISPANICA)
Baked products
Pekovski izdelki
not more than 10 %
ne več kot 10 %
Fruit, nut and seed mixes
Mešanice sadja, oreškov in semen
Pre-packaged Chia seed as such
Predpakirana semena oljne kadulje
not more than 15 g per day
ne več kot 15 g dnevno
of 23 January 2013
z dne 23. januarja 2013
on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council
o oceni ureditvenega okvira tretje države, ki se uporablja za zdravilne učinkovine zdravil za uporabo v humani medicini, ter zadevnih dejavnosti nadzora in izvrševanja v skladu s členom 111b Direktive 2001/83/ES Evropskega parlamenta in Sveta
Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use [1], and in particular Article 111b(2) thereof,
ob upoštevanju Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [1], zlasti člena 111b(2) Direktive,
Article 111b(1) of Directive 2001/83/EC specifies the aspects of which the Commission must take particular account when assessing whether a third country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union.
Člen 111b(1) Direktive 2001/83/ES določa vidike, ki jih mora Komisija zlasti upoštevati pri oceni, ali ureditveni okvir tretje države, ki se uporablja za zdravilne učinkovine, ki se izvažajo v Unijo, ter zadevne dejavnosti nadzora in izvrševanja zagotavljajo raven varovanja javnega zdravja, enakovredno ravni v Uniji.
It should be set out in more detail which aspects and respective EU documents are taken into account when conducting the equivalence assessment in accordance with Article 111b(1) of Directive 2001/83/EC.
Podrobneje bi bilo treba določiti, kateri vidiki in dokumenti EU se upoštevajo pri ugotavljanju enakovrednosti v skladu s členom 111b(1) Direktive 2001/83/ES.
This Decision specifies how the aspects referred to in points (a) to (d) of Article 111b(1) of Directive 2001/83/EC are to be assessed for the purposes of determining whether a third country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union.
Ta sklep opredeljuje, kako je treba vidike iz točk (a) do (d) člena 111b(1) Direktive 2001/83/ES oceniti pri ugotavljanju, ali ureditveni okvir tretje države, ki se uporablja za zdravilne učinkovine, ki se izvažajo v Unijo, ter zadevne dejavnosti nadzora in izvrševanja zagotavljajo raven varovanja javnega zdravja, enakovredno ravni v Uniji.
For the purposes of assessing the equivalence of the level of protection of public health ensured by a third country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC, the requirements set out in points (a) to (d) of Article 111b(1) shall be applied as follows:
Pri ugotavljanju enakovrednosti ravni varovanja javnega zdravja, ki jo zagotavlja ureditveni okvir tretje države, ki se uporablja za zdravilne učinkovine, ki se izvažajo v Unijo, ter zadevnih dejavnosti nadzora in izvrševanja v skladu s členom 111b Direktive 2001/83/ES se upoštevajo zahteve iz točk (a) do (d) člena 111b(1), kot sledi:
in applying point (a) of Article 111b(1), the Commission shall take into account the applicable guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC;
pri uporabi točke (a) člena 111b(1) Komisija upošteva veljavne smernice iz drugega odstavka člena 47 Direktive 2001/83/ES;
in applying point (b) of Article 111b(1), the Commission shall take into account the applicable guidelines referred to in Article 3(1) of Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use [2];
pri uporabi točke (b) člena 111b(1) Komisija upošteva veljavne smernice iz člena 3(1) Direktive Komisije 2003/94/ES z dne 8. oktobra 2003 o določitvi načel in smernic dobre proizvodne prakse v zvezi z zdravili za uporabo v humani medicini in zdravili za uporabo v humani medicini v preskušanju [2];
in applying point (c) of Article 111b(1), the Commission shall assess inspection resources, the qualification and training of inspectors, inspection procedures, inspection strategies and mechanisms to address conflicts of interest, inspection performance standards, enforcement powers, alert and crisis mechanisms, and analytical capacity taking into account the applicable guidelines referred to in Article 3(1) of Directive 2003/94/EC;
pri uporabi točke (c) člena 111b(1) Komisija oceni inšpekcijske vire, izobrazbo in usposabljanja inšpektorjev, inšpekcijske postopke, inšpekcijske strategije in mehanizme za obravnavo navzkrižja interesov, standarde izvedbe inšpekcijskega pregleda, izvršilna pooblastila, mehanizme opozarjanja in kriznega upravljanja ter analitične zmogljivosti ob upoštevanju veljavnih smernic iz člena 3(1) Direktive 2003/94/ES;
in applying point (d) of Article 111b(1), the Commission shall assess the third country’s arrangements in order to ensure regular and rapid provision of information by the third country to the EU in relation to non-compliant producers of active substances.
pri uporabi točke (d) člena 111b(1) Komisija oceni ureditve tretjih držav za zagotavljanje, da se redno in hitro posredujejo informacije EU glede neskladnih proizvajalcev zdravilnih učinkovin.
Done at Brussels, 23 January 2013.
V Bruslju, 23. januarja 2013
authorising enhanced cooperation in the area of financial transaction tax
o odobritvi okrepljenega sodelovanja na področju davka na finančne transakcije
Having regard to the requests made by the Kingdom of Belgium, the Federal Republic of Germany, the Republic of Estonia, the Hellenic Republic, the Kingdom of Spain, the French Republic, the Italian Republic, the Republic of Austria, the Portuguese Republic, the Republic of Slovenia and the Slovak Republic,
ob upoštevanju prošenj Kraljevine Belgije, Zvezne republike Nemčije, Republike Estonije, Helenske republike, Kraljevine Španije, Francoske republike, Italijanske republike, Republike Avstrije, Portugalske republike, Republike Slovenije in Slovaške republike,
In accordance with Article 3(3) of the Treaty on European Union (TEU), the Union shall establish an internal market.
V skladu s členom 3(3) Pogodbe o Evropski uniji (PEU) Unija vzpostavi notranji trg.
Pursuant to Article 113 of the Treaty on the Functioning of the European Union (TFEU) the Council shall adopt provisions for the harmonisation of legislation concerning turnover taxes, excise duties and other forms of indirect taxation to the extent that such harmonisation is necessary to ensure the establishment and the functioning of the internal market and to avoid distortion of competition.
V skladu s členom 113 Pogodbe o delovanju Evropske unije (PDEU) Svet sprejme določbe za harmonizacijo zakonodaje glede prometnih davkov, trošarin in drugih oblik posrednega obdavčenja, če je ta harmonizacija potrebna za vzpostavitev in delovanje notranjega trga in preprečevanje izkrivljanja konkurence.
In 2011, the Commission took note of a debate which was ongoing at all levels on additional taxation of the financial sector.
Komisija je leta 2011 ugotovila, da je na vseh ravneh potekala razprava o dodatni obdavčitvi finančnega sektorja.
This debate originates from the desire to ensure that the financial sector fairly and substantially contributes to the costs of the crisis and that it is taxed in a fair way vis-à-vis other sectors for the future, to disincentivise excessively risky activities by financial institutions, to complement regulatory measures aimed at avoiding future crises and to generate additional revenue for general budgets or specific policy purposes.
Vzrok za to razpravo je želja po zagotovitvi, da finančni sektor pošteno in znatno prispeva h kritju stroškov krize in bo v prihodnosti obdavčen na pravičen način v primerjavi z drugimi sektorji, po preprečevanju pretirano tveganih dejavnosti finančnih institucij, dopolnitvi regulativnih ukrepov, namenjenih izogibanju prihodnjim krizam, in dodatnih prihodkih za splošni proračun ali posebne namene politike.
Against this background, on 28 September 2011, the Commission adopted a proposal for a Council Directive on a common system of financial transaction tax and amending Directive 2008/7/EC [1].
Na podlagi tega je Komisija 28. septembra 2011 sprejela predlog direktive Sveta o skupnem sistemu davka na finančne transakcije in o spremembi Direktive 2008/7/ES [1].
The main objective of that proposal was to ensure the proper functioning of the internal market and to avoid distortion of competition.
Glavni cilj tega predloga je bil zagotoviti pravilno delovanje notranjega trga in preprečiti izkrivljanje konkurence.
At the Council meeting of 22 June 2012, it was ascertained that there was no unanimous support for a common system of financial transaction tax (FTT) as proposed by the Commission.
Na zasedanju Sveta 22. junija 2012 je bilo ugotovljeno, da podpora skupnemu sistemu davka na finančne transakcije, kot ga je predlagala Komisija, ni bila soglasna.
The European Council concluded on 29 June 2012 that the proposed Directive would not be adopted by the Council within a reasonable period.
Evropski svet je 29. junija 2012 zaključil, da Svet ne bo sprejel predlagane direktive v razumnem roku.
At the Council meeting of 10 July 2012, reference was made to persisting and essential differences in opinion as regards the need to establish a common system of FTT at the Union level and it was confirmed that the principle of harmonised taxation on financial transactions will not receive unanimous support within the Council in the foreseeable future.
Na zasedanju Sveta 10. julija 2012 je bilo poudarjeno, da še vedno obstajajo bistvena razhajanja v zvezi s potrebo po vzpostavitvi skupnega sistema davka na finančne transakcije na ravni Unije, in potrjeno, da načelo harmoniziranega obdavčevanja finančnih transakcij v bližnji prihodnosti ne bo prejelo soglasne podpore v Svetu.