natgillin/translations-raw huggingface dataset:
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘clorsulon’ is replaced by the following:
V razpredelnici 1 Priloge k Uredbi (EU) št. 37/2010 se vnos za snov klorsulon nadomesti z naslednjim:
Therapeutic Classification
„klorsulon
‘Clorsulon
klorsulon
Clorsulon
govedo
Antiparasitic agents/Agents against endoparasites’
jetra
Commission Implementing Regulation (EU) No 684/2014
Izvedbena uredba Komisije (EU) št. 684/2014
concerning the authorisation of canthaxanthin as a feed additive for breeder hens (holder of the authorisation DSM Nutritional products Ltd)
o izdaji dovoljenja za kantaksantin kot krmni dodatek za plemenske kokoši (imetnik dovoljenja DSM Nutritional Products Ltd)
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [1], and in particular Article 9(2) thereof,
ob upoštevanju Uredbe Evropskega parlamenta in Sveta (ES) št. 1831/2003 z dne 22. septembra 2003 o dodatkih za uporabo v prehrani živali [1] in zlasti člena 9(2) Uredbe,
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a canthaxanthin.
V skladu s členom 7 Uredbe (ES) št. 1831/2003 je bil vložen zahtevek za izdajo dovoljenja za kantaksantin.
That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
V skladu s členom 7(3) Uredbe (ES) št. 1831/2003 so bili navedenemu zahtevku priloženi zahtevani podatki in dokumenti.
That application concerns the authorisation of a preparation of canthaxanthin as a feed additive for breeder hens to be classified in the additive category ‘zootechnical additives’.
Navedeni zahtevek se nanaša na dovoljenje za pripravek kantaksantina kot krmni dodatek za plemenske kokoši ter njegovo uvrstitev v kategorijo dodatkov „zootehnični dodatki“.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 December 2012 [2] that, under the proposed conditions of use, the preparation of canthaxanthin does not have an adverse effect on animal health, human health or the environment, and that it has a potential to stabilise the reproductive performance of breeder hens.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v mnenju z dne 12. decembra 2012 [2] navedla, da pripravek kantaksantina pod predlaganimi pogoji uporabe nima škodljivega vpliva na zdravje živali in ljudi ali na okolje ter da njegova uporaba lahko stabilizira reproduktivno zmožnost plemenskih kokoši.
It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
Potrdila je tudi poročilo o analitski metodi krmnega dodatka, ki ga je predložil referenčni laboratorij, ustanovljen z Uredbo (ES) št. 1831/2003.
The assessment of the preparation of canthaxanthin shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Ocena pripravka kantaksantina je pokazala, da so pogoji za dovoljenje iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni.
Maximum residues limits in the relevant foodstuffs of animal origin
Mejne vrednosti ostankov v ustreznih živilih živalskega izvora
Preparation containing minimum:
Pripravek, ki vsebuje najmanj:
≤ 2,2 % ethoxyquin;
≤ 2,2 % etoksikvina;
dichloromethane:
diklormetana:
≤ 10 mg/kg additive.
≤ 10 mg/kg dodatka.
C40H52O2 CAS No:
C40H52O2
Minimum 96 %
Analitska metoda [1]
Produced by chemical synthesis
Za določanje kantaksantina v krmnem dodatku:
Analytical method [1]
spektrofotometrija (426 nm)
For the determination of canthaxanthin in the feed additive:
Za določanje kantaksantina v premiksih in krmi:
spectrophotometry (426 nm)
normalna faza tekočinske kromatografije visoke ločljivosti v povezavi z detekcijo VIS (NP-HPLC-VIS, 466 nm)
For the determination of canthaxanthin in premixtures and feedingtuffs:
plemenske kokoši
Normal Phase High Performance Liquid Chromatography coupled to VIS detection (NP-HPLC-VIS, 466 nm)
V navodilih za uporabo dodatka in premiksa je treba navesti pogoje skladiščenja in obstojnost pri toplotni obdelavi.
Breeder hens
Mešanica iz različnih virov kantaksantina ne presega 6 mg/kg popolne krmne mešanice.
In the directions for use of the additive and premixture, indicate the storage conditions and stability to heat processing.
Mešanica tega pripravka s kantaksantinom z drugimi karotenoidi je dovoljena, če celotna koncentracija mešanice ne presega 80 mg/kg popolne krmne mešanice.
The mixture of different sources of canthaxanthin shall not exceeded 6 mg canthaxanthin/kg of complete feedingstuff.
10. julij 2024
The mixture of this preparation with canthaxanthin and other carotenoids is allowed provided that the total concentration of the mixture does not exceed 80 mg/kg of complete feedingstuff.
15 mg kantaksantina/kg jeter (mokro tkivo) in 2,5 mg kantaksantina/kg kože/maščob (mokro tkivo)
10 July 2024
Funkcionalna skupina:
15 mg canthaxanthin/kg liver (wet tissue) and 2,5 mg canthaxanthin/kg skin/fat (wet tissue)
drugi zootehnični dodatki (stabilizacija razmnoževalne sposobnosti)
Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives:
Zaradi varnosti uporabnika je pri ravnanju treba nositi zaščito za dihala ter zaščitna očala in rokavice.
www.irmm.jrc.be/eurl-feed-additives
št.
Commission Regulation (EU) No 685/2014
Uredba Komisije (EU) št. 685/2014
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards polyvinyl alcohol-polyethylene glycol-graft-co-polymer in solid food supplements
o spremembi Priloge II k Uredbi (ES) št. 1333/2008 Evropskega parlamenta in Sveta ter Priloge k Uredbi Komisije (EU) št. 231/2012 glede uporabe polivinil alkohol-polietilen glikol-graft-kopolimera v trdnih prehranskih dopolnilih
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives [1], and in particular Article 10(3) and Article 14 thereof,
ob upoštevanju Uredbe (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila [1] in zlasti člena 10(3) in člena 14 Uredbe,
Commission Regulation (EU) No 231/2012 [3] lays down specifications for food additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.
V Uredbi Komisije (EU) št. 231/2012 [3] so določene specifikacije za aditive za živila, navedene v prilogah II in III k Uredbi (ES) št. 1333/2008.
Those lists may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application.
Navedeni seznami se lahko na pobudo Komisije ali na podlagi zahtevka posodobijo v skladu s skupnim postopkom iz člena 3(1) Uredbe (ES) št. 1331/2008.
On 13 September 2011, an application was submitted for authorisation of the use of polyvinyl alcohol-polyethylene glycol-graft-co-polymer (PVA-PEG graft co-polymer) in aqueous instant-release film coatings for food supplements.
Zahtevek za odobritev uporabe polivinil alkohol-polietilen glikol-graft-kopolimera (v nadaljnjem besedilu: PVA-PEG graft kopolimer) v hitro vodotopnih filmskih oblogah za prehranska dopolnila je bil vložen 13. septembra 2011.
The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.
Zahtevek je bil dan na voljo državam članicam v skladu s členom 4 Uredbe (ES) št. 1331/2008.
The European Food Safety Authority evaluated the safety of PVA-PEG graft co-polymer when used as a food additive and concluded that its use in food supplements as film coating is of no safety concern for the proposed uses [4].
Evropska agencija za varnost hrane je ocenila varnost PVA-PEG graft kopolimera, kadar se uporablja kot aditiv za živila, in ugotovila, da predlagani načini njegove uporabe v filmskih oblogah za prehranska dopolnila ne pomenijo tveganja za varnost.
It protects against unpleasant tastes or odours, improves appearance, makes tablets easier to swallow, gives a distinctive appearance, and protects sensitive active ingredients.
PVA-PEG graft kopolimer je namenjen uporabi v hitro vodotopnih filmskih oblogah za prehranska dopolnila.
A specific property of the substance is that it is extremely flexible, has low viscosity, and dissolves rapidly in acidic, neutral, and alkaline aqueous media.
Ščiti pred neprijetnim okusom ali vonjem, izboljša videz, zaradi njega se tablete lažje pogoltnejo in imajo značilen videz, ščiti pa tudi občutljive farmakološko aktivne snovi.
It is therefore appropriate to authorise the use of PVA-PEG graft co-polymer as a glazing agent in solid food supplements and to assign E 1209 as E-number to that additive.
Posebna lastnost te snovi je, da je izjemno prožna, ima nizko viskoznost ter se hitro topi v kislih, nevtralnih in bazičnih vodnih medijih.
The specifications for PVA-PEG graft co-polymer should be included in Regulation (EU) No 231/2012 when it is included in the Union lists of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time.
Zato je primerno odobriti uporabo PVA-PEG graft kopolimera kot sredstva za glaziranje v trdnih prehranskih dopolnilih in navedenemu aditivu dodeliti E-številko E 1209.
Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly.
Specifikacije za PVA-PEG graft kopolimer bi bilo treba vključiti v Uredbo (EU) št. 231/2012, ko bo navedeni aditiv prvič vključen na seznam Unije aditivov za živila iz Priloge II k Uredbi (ES) št. 1333/2008.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
Uredbi (ES) št. 1333/2008 in (EU) št. 231/2012 bi bilo zato treba ustrezno spremeniti.
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.
Člen 1
Article 2
Priloga II k Uredbi (ES) št. 1333/2008 se spremeni v skladu s Prilogo I k tej uredbi.
The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.
Člen 2
Article 3
Priloga k Uredbi (EU) št. 231/2012 se spremeni v skladu s Prilogo II k tej uredbi.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Člen 3
Done at Brussels, 20 June 2014.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
For the Commission
V Bruslju, 20. junija 2014
OJ L 354, 31.12.2008, p. 16.
Predsednik
OJ L 354, 31.12.2008, p. 1.
UL L 354, 31.12.2008, str. 16.
Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).
UL L 354, 31.12.2008, str. 1.
in Part B, point 3 ‘Additives other than colours and sweeteners’, the following new entry is inserted after the entry for food additive E 1208 Polyvinylpyrrolidone-vinyl acetate copolymer:
V delu B se v točki 3 „Aditivi razen barvil in sladil“ za vnosom za aditiv za živila E 1208: kopolimer polivinilpirolidon-vinil acetata vstavi naslednji novi vnos:
Polyvinyl alcohol-polyethylene glycol-graft-co-polymer’
polivinil alkohol-polietilen glikol-graft-kopolimer“
in Part E, in food category 17.1 ‘Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms’, the following new entry is inserted after the entry for food additive E 1208:
V delu E se v kategorijo živil 17.1 „Prehranska dopolnila, dobavljena v trdni obliki, vključno s kapsulami in tabletami ter podobnimi oblikami, razen za žvečenje“ za vnosom za aditiv za živila E 1208 vstavi naslednji novi vnos:
Polyvinyl alcohol-polyethylene glycol-graft-co-polymer
polivinil alkohol-polietilen glikol-graft-kopolimer
In the Annex to Regulation (EU) No 231/2012, the following new entry is inserted after the entry for E 1208 (Polyvinylpyrrolidone-vinyl acetate copolymer):
V Prilogi k Uredbi (EU) št. 231/2012 se za vnosom za aditiv za živila E 1208 (kopolimer polivinilpirolidon-vinil acetata) vstavi naslednji novi vnos:
Macrogol poly(vinyl alcohol) grafted co-polymer;
cepljeni kopolimer makrogol poli(vinil alkohola);
ethenol, polymer with oxirane, graft;
etenol, polimer z oksiranom, graft;
oxirane, polymer with ethanol, graft;
oksiran, polimer z etanolom, graft;
Polyvinyl alcohol-polyethylene glycol-graft-co-polymer is a synthetic co-polymer that consists of approximately 75 % PVA units and 25 % PEG units.
Polivinil alkohol-polietilen glikol-graft-kopolimer je sintetični kopolimer, ki vsebuje približno 75 % enot PVA in 25 % enot PEG.
CAS number
Št.
Chemical name
CAS
Chemical formula
Kemijsko ime
Weight Average Molecular Weight
Kemijska formula
40000 to 50000 g/mol
Masno povprečje molekulske mase
Description
40000 do 50000 g/mol
White to faintly yellow powder
Opis
Identification
bel do bledo rumen prah
Solubility
Identifikacija
Freely soluble in water and dilute acids and dilute solutions of alkali hydroxides;
Topnost
practically insoluble in ethanol, acetic acid, acetone, and chloroform
Dobro topen v vodi ter razredčenih kislinah in razredčenih raztopinah bazičnih hidroksidov;
IR Spectrum
skoraj netopen v etanolu, ocetni kislini, acetonu in kloroformu.
Must comply
IR spekter
pH value
mora biti ustrezen
5,0-8,0
pH-vrednost
Purity
5,0–8,0
Ester Value
Čistost
10 to 75 mg/g KOH
Estrsko število
Dynamic viscosity
10 do 75 mg/g KOH
50 to 250 mPa·s
Dinamična viskoznost
Loss on drying
50 do 250 mPa s
Not more than 5 %
Izguba pri sušenju
Sulphated Ash
ne več kot 5 %
Not more than 2 %
Sulfatni pepel
Vinyl Acetate
ne več kot 2 %
Not more than 20 mg/kg
Vinilacetat
Acetic acid/Total Acetate
ne več kot 20 mg/kg
Not more than 1,5 %
Ocetna kislina/acetat skupaj
Ethylene glycol
ne več kot 1,5 %
Not more than 50 mg/kg
Etilen glikol
Diethylene glycol
ne več kot 50 mg/kg
1,4-Dioxane
Dietilen glikol
Not more than 10 mg/kg
1,4-dioksan
Ethylene oxide
ne več kot 10 mg/kg
Not more than 0,2 mg/kg
Etilen oksid
Arsenic
ne več kot 0,2 mg/kg
Not more than 3 mg/kg
Arzen
Lead
ne več kot 3 mg/kg
Not more than 1 mg/kg
Svinec
Mercury
ne več kot 1 mg/kg
Cadmium
Živo srebro
Not more than 1 mg/kg’
Kadmij
Commission Regulation (EU) No 686/2014
Uredba Komisije (EU) št. 686/2014
amending Regulations (EC) No 983/2009 and (EU) No 384/2010 as regards the conditions of use of certain health claims related to the lowering effect of plant sterols and plant stanols on blood LDL-cholesterol
o spremembi uredb (ES) št. 983/2009 in (EU) št. 384/2010 v zvezi s pogoji uporabe nekaterih zdravstvenih trditev o učinku rastlinskih sterolov in rastlinskih stanolov na zniževanje LDL-holesterola v krvi
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 17(3) thereof,
ob upoštevanju Uredbe (ES) št. 1924/2006 Evropskega parlamenta in Sveta z dne 20. decembra 2006 o prehranskih in zdravstvenih trditvah na živilih [1] ter zlasti člena 17(3) Uredbe,
Regulation (EC) No 1924/2006 provides that applications for authorisations of health claims are to be sent to the national competent authority of the respective Member State.
Uredba (ES) št. 1924/2006 določa, da se vloge za odobritev zdravstvenih trditev vložijo pri pristojnem nacionalnem organu zadevne države članice.
The national competent authority is to forward those applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’.
Pristojni nacionalni organ te vloge pošlje Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija).
The Authority is to give an opinion on the health claim and to forward it to the Commission who is to decide on the authorisation of the health claim taking into account the opinion delivered by the Authority.
Agencija mora izdati mnenje o zdravstveni trditvi in ga poslati Komisiji, ki se mora odločiti o odobritvi zdravstvene trditve ob upoštevanju mnenja Agencije.
Pursuant to Article 16(4) of Regulation (EC) No 1924/2006, an opinion of the Authority in favour of authorising a health claim may include specific conditions of use of the claim.
V skladu s členom 16(4) Uredbe (ES) št. 1924/2006 lahko pozitivno mnenje Agencije o odobritvi zdravstvene trditve vključuje posebne pogoje uporabe trditve.
The authorisation of health claims may be amended following a request by the applicant or user according to Article 19(1) of Regulation (EC) No 1924/2006 or following an opinion of the Authority issued on its own initiative or following a request from a Member State or from the Commission according to Article 19(2) of Regulation (EC) No 1924/2006.
Odobritev zdravstvenih trditev se lahko spremeni na podlagi zahteve vložnika ali uporabnika v skladu s členom 19(1) Uredbe (ES) št. 1924/2006 ali pa na podlagi mnenja, ki ga Agencije izda na lastno pobudo ali na zahtevo države članice ali Komisije v skladu s členom 19(2) Uredbe (ES) št. 1924/2006.
Following the opinion of the Authority, based on a request of the Commission and a similar request from France, regarding the possibility to indicate a quantitative effect in health claims related to the lowering effects of plant sterols/plant stanol esters on blood LDL-cholesterol (Question No EFSA-Q-2009-00530 and Q-2009-00718) [2], the Commission amended, by Regulation (EU) No 376/2010 [3], the conditions of use of two health claims related to the lowering effects of plant sterols and plant stanol esters on blood cholesterol, as laid down in Commission Regulation (EC) No 983/2009 [4], by indicating a quantitative effect.
Komisija je na podlagi mnenja Agencije, izdanega na zahtevo Komisije in podobno zahtevo Francije v zvezi z možnostjo navedbe kvantitativnega učinka v zdravstvenih trditvah o učinku rastlinskih sterolov/estrov rastlinskih stanolov na zniževanje LDL-holesterola v krvi (vprašanji št.
Moreover, based on the same opinion of the Authority, the Commission authorised, by Regulation (EU) No 384/2010 [5], a health claim related to the lowering effects of plant sterols/plant stanol esters on blood LDL-cholesterol, establishing conditions of use related to the indication of a quantitative effect.
EFSA-Q-2009-00530 in Q-2009-00718) [2], z Uredbo (EU) št. 376/2010 [3] spremenila pogoje uporabe dveh zdravstvenih trditev o učinku rastlinskih sterolov in estrov rastlinskih stanolov na zniževanje holesterola v krvi, kot so določeni v Uredbi Komisije (ES) št. 983/2009 [4], tako da je določila obvezno navedbo kvantitativnega učinka.
Following an application from Raisio Nutrition Ltd, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the lowering effects of plant stanols as plant stanol esters on blood LDL-cholesterol concentrations (Question No EFSA-Q-2011-00851) [6].
Poleg tega je Komisija na podlagi istega mnenja z Uredbo (EU) št. 384/2010 [5] odobrila zdravstveno trditev o učinku rastlinskih sterolov/estrov rastlinskih stanolov na zniževanje LDL-holesterola v krvi in določila pogoje uporabe v zvezi z navedbo kvantitativnega učinka.
The claim proposed by the applicant was worded as follows:
Družba Raisio Nutrition Ltd. je v skladu s členom 14(1)(a) Uredbe (ES) št. 1924/2006 vložila vlogo, Agencija pa je morala pripraviti mnenje o zdravstveni trditvi o učinku rastlinskih sterolov v obliki estrov rastlinskih stanolov na zniževanje koncentracije LDL-holesterola v krvi (vprašanje št.
The applicant further requested that the minimum duration to obtain the effect be stated to be one to two weeks, and that an authorisation be given for claims for an extended range of foods, including yellow fat spreads, dairy products, cheese, rye bread, oatmeal, fermented soy milk based products (drinkable and spoonable yoghurt-type products), and oat-based milk drinks.
Na podlagi predloženih podatkov je Agencija v svojem mnenju, ki so ga Komisija in države članice prejele 16. maja 2012, ugotovila, da estri rastlinskih stanolov pri dnevnem vnosu 3 g (od 2,7 do 3,3 g) znižajo raven LDL-holesterola v krvi za 11,4 % (95-odstotni interval zaupanja (CI): 9,8–13,0) in da je najkrajši čas, ki je potreben za dosego največjega učinka estrov rastlinskih stanolov na znižanje LDL-holesterola v krvi, dva do tri tedne.
On the basis of the data presented, the Authority concluded in its opinion, received by the Commission and the Member States on 16 May 2012, that plant stanol esters at a daily intake of 3 g (range 2,7-3,3 g) lower blood LDL-cholesterol by 11,4 % (95 % Confidence Interval (CI): 9,8-13,0), and that the minimum duration required to achieve the maximum effect of plant stanol esters on blood LDL-cholesterol lowering is two to three weeks.
Poleg tega je Agencija ugotovila, da v nasprotju z dosledno dokazanim učinkom na zniževanje ravni LDL-holesterola v krvi, ki ga imajo estri rastlinskih stanolov, dodani živilom, kot so margarini sorodni namazi, majoneza, solatni prelivi in mlečni izdelki, kot so mleko, jogurti, vključno z jogurti z manj maščobe, in sir, učinek na zniževanje holesterola, ki ga imajo rastlinski stanoli, dodani drugim oblikam živil, ni tako dobro določen.
Moreover, the Authority concluded that while plant stanol esters added to foods such as margarine-type spreads, mayonnaise, salad dressings and to dairy products such as milk, yoghurts including low-fat yoghurts, and cheese have been shown consistently to lower blood LDL-cholesterol levels, the extent of the cholesterol-lowering effect of plant stanols added to other food formats is less well established.
Družbi Unilever PLC in Unilever NV sta v skladu s členom 19 Uredbe (ES) št. 1924/2006 vložili vlogo za spremembo pogojev uporabe zdravstvenih trditev o učinku rastlinskih sterolov in rastlinskih stanolov na zniževanje LDL-holesterola v krvi (vprašanje št.
Unilever PLC and Unilever NV submitted an application pursuant to Article 19 of Regulation (EC) No 1924/2006, for the modification of the conditions of use of the health claims related to the lowering effects of plant sterols and plant stanols on blood LDL-cholesterol (Question No EFSA-Q-2011-01241) [7].
EFSA-Q-2011-01241) [7].
The modification concerns the magnitude of the lowering effect on blood LDL-cholesterol (7-12 %) for a daily intake of plant sterols and plant stanols between 1,5 and 3 g.
Sprememba zadeva moč učinka na znižanje LDL-holesterola v krvi (7–12 %) pri dnevnem vnosu rastlinskih sterolov in rastlinskih stanolov od 1,5 do 3 g.
The applicant further requested that the minimum duration to obtain the effect be stated to be one to two weeks.
Vložnik je tudi zahteval, da je navedeni najkrajši čas za dosego učinka en do dva tedna.
On the basis of the data presented, the Authority concluded in its opinion, received by the Commission and the Member States on 16 May 2012, that plant sterols and plant stanol esters at a daily intake of 3 g (range 2,6-3,4 g) lower blood LDL-cholesterol by 11,3 % (95 % Confidence Interval (CI): 10,0-12,5), and that the minimum duration required to achieve the maximum effect of plant sterols and plant stanols on LDL-cholesterol is two to three weeks.
Na podlagi predloženih podatkov je Agencija v svojem mnenju, ki so ga Komisija in države članice prejele 16. maja 2012, ugotovila, da rastlinski steroli in estri rastlinskih stanolov pri dnevnem vnosu 3 g (od 2,6 do 3,4 g) znižajo raven LDL-holesterola v krvi za 11,3 % (95-odstotni interval zaupanja (CI): 10,0–12,5) in da je najkrajši čas, ki je potreben za dosego največjega učinka rastlinskih sterolov in rastlinskih stanolov na znižanje LDL-holesterola, dva do tri tedne.
The Authority also noted in its assessment that plant sterols and plant stanols at daily intakes ranging from 1,5 to 3 g have a similar efficacy on lowering blood LDL-cholesterol.
Agencija je v svoji oceni tudi navedla, da je učinek rastlinskih sterolov in rastlinskih stanolov na zniževanje LDL-holesterola v krvi pri dnevnem vnosu od 1,5 do 3 g, podoben.