natgillin/translations-raw huggingface dataset:
Dietary foods for special medical purposes are defined by Commission Directive 1999/21/EC [5] as a category of foods for particular nutritional uses specially processed or formulated and intended for the dietary management of patients and to be used under medical supervision.
Ob upoštevanju podatkov o porabi živil za posebne zdravstvene namene iz celovite podatkovne baze Agencije o porabi živil [6] in ob predpostavki, da bi živila vsebovala aluminij pri najvišji dovoljeni vsebnosti 3 mg/kg, bi izpostavljenost aluminiju prek navedenih živil ostala precej pod sprejemljivim tedenskim vnosom, ki znaša 1 mg/kg telesne teže/teden za odrasle in otroke.
They are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two.
Glede na to, da bi bila izpostavljenost aluminiju iz drugih prehrambnih virov omejena, zlasti v primeru popolne prehrane, se ne pričakuje, da bi bil pri bolnikih, ki uživajo živila za posebne zdravstvene namene, presežen sprejemljiv tedenski vnos.
Taking into account the consumption data for dietary foods for special medical purposes from the EFSA Comprehensive European Food Consumption Database [6] and assuming that they would contain aluminium at the maximum level of 3 mg/kg, the exposure to aluminium from those foods remains well below the TWI — 1 mg/kg body weight/week for both adults and children.
V skladu s členom 3(2) Uredbe (ES) št. 1331/2008 mora Komisija za posodobitev seznama Unije aditivov za živila iz Priloge II k Uredbi (ES) št. 1333/2008 zaprositi za mnenje Agencije, razen če taka posodobitev ne bo imela učinka na zdravje ljudi.
Therefore, considering that the exposure to aluminium from other dietary sources would be limited especially in case of the exclusive feeding it is not expected that the TWI would be exceeded for patients consuming dietary foods for special medical purposes.
Ker razširitev uporabe aluminijevih lakov košenilje, karminske kisline in karminov pomeni posodobitev navedenega seznama, ki ne vpliva na zdravje ljudi, se Komisiji ni treba posvetovati z Agencijo.
Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where such update is not liable to have an effect on human health.
Zato bi bilo treba ustrezno spremeniti Prilogo II k Uredbi (ES) št. 1333/2008.
Since the extension of use of aluminium lakes of cochineal, carminic acid, carmines constitute an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za rastline, živali, hrano in krmo –
Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly.
SPREJELA NASLEDNJO UREDBO:
HAS ADOPTED THIS REGULATION:
Priloga II k Uredbi (ES) št. 1333/2008 se spremeni v skladu s Prilogo k tej uredbi.
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
V Bruslju, 31. marca 2015
Done at Brussels, 31 March 2015.
Predsednik
The President
Uredba (ES) št. 1331/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila (UL L 354, 31.12.2008, str. 1).
OJ L 354, 31.12.2008, p. 16.
Znanstveno mnenje Odbora za aditive za živila, arome, pomožna tehnološka sredstva in materiale za stik z živili o varnosti vnosa aluminija s hrano (EFSA Journal (2008) 754, str. 1).
Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1.).
Uredba Komisije (EU) št. 380/2012 z dne 3. maja 2012 o spremembi Priloge II k Uredbi (ES) št. 1333/2008 Evropskega parlamenta in Sveta v zvezi s pogoji in ravnmi uporabe za aditive za živila, ki vsebujejo aluminij (UL L 119, 4.5.2012, str. 14).
Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC) on Safety of aluminium from dietary intake, (EFSA Journal (2008) 754, p. 1).
Direktiva Komisije 1999/21/ES z dne 25. marca 1999 o živilih za posebne zdravstvene namene (UL L 91, 7.4.1999, str. 29).
Commission Regulation (EU) No 380/2012 of 3 May 2012 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the conditions of use and the use levels for aluminium-containing food additives (OJ L 119, 4.5.2012, p. 14).
PRILOGA
Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, p. 29).
Del E Priloge II k Uredbi (ES) št. 1333/2008 se spremeni:
ANNEX
„skupina III
Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5) the entry for Group III is replaced by the following:
Ne smejo se uporabljati nobeni drugi aluminijevi laki.
‘Group III
Navedena dovoljena vsebnost se za namene člena 22(1)(g) Uredbe (ES) št. 1333/2008 uporablja od 1. februarja 2013.“
Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5) the following footnote is added:
Od 1. avgusta 2014 so odobreni samo aluminijevi laki, pripravljeni iz barvil iz preglednice 3 dela A Priloge II k Uredbi (ES) št. 1333/2008 in samo v kategorijah živil, za katere so v delu E navedene priloge izrecno navedene določbe o najvišji dovoljeni vsebnosti aluminija iz lakov.
Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 3 mg/kg only in liquid heat-treated products.
v kategoriji živil 13.2 Živila za posebne zdravstvene namene, kot so opredeljena v Direktivi 1999/21/ES (razen proizvodov iz živilske kategorije 13.1.5), se vnos za skupino III nadomesti z naslednjim:
No other aluminium lakes may be used.
v kategoriji živil 13.2 Živila za posebne zdravstvene namene, kot so opredeljena v Direktivi 1999/21/ES (razen proizvodov iz živilske kategorije 13.1.5), se doda naslednja opomba:
For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013’
http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm.
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of benzoic acid — benzoates (E 210-213) in cooked shrimps in brine
o spremembi Priloge II k Uredbi (ES) št. 1333/2008 Evropskega parlamenta in Sveta glede uporabe benzojske kisline – benzoatov (E 210–213) v kuhanih kozicah v slanici
That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council [2], either on the initiative of the Commission or following an application.
Navedeni seznam se lahko na pobudo Komisije ali na podlagi zahtevka posodobi v skladu s skupnim postopkom iz člena 3(1) Uredbe (ES) št. 1331/2008 Evropskega parlamenta in Sveta [2].
A request to amend the Union list of food additives has been submitted by the Danish Seafood Association in order to increase the maximum permitted level of benzoic acid — benzoates (E 210-213) in cooked shrimps in brine.
Zahtevo za spremembo seznama Unije aditivov za živila je predložila danska Zveza za morsko hrano, da bi se povišala najvišja dovoljena vsebnost benzojske kisline – benzoatov (E 210–213) v kuhanih kozicah v slanici.
Annex II to Regulation (EC) No 1333/2008 sets maximum limits for the use of sorbic acid — sorbates; benzoic acid — benzoates (E 200-213) of 2000 mg/kg in semi-preserved fish and fisheries products including crustaceans, molluscs, surimi and fish/crustacean paste; cooked crustaceans and molluscs.
Priloga II k Uredbi (ES) št. 1333/2008 določa mejne vsebnosti za uporabo sorbinske kisline – sorbatov; benzojske kisline – benzoatov (E 200–213) 2000 mg/kg v polkonzerviranih ribah in ribiških proizvodih, vključno z raki, mehkužci, surimijem ter ribjo pašteto/pašteto iz rakov; kuhanih rakih in mehkužcih.
In cooked crustaceans and molluscs the total maximum permitted level of benzoic acid — benzoates (E 210-213) is furthermore 1000 mg/kg.
Poleg tega je v kuhanih rakih in mehkužcih skupna najvišja dovoljena vsebnost benzojske kisline – benzoatov (E 210–213) 1000 mg/kg.
These maximum permitted levels in cooked and brined shrimps with pH of 5,6 to 5,7 should be sufficient to inhibit the growth of Listeria monocytogenes at cooling temperatures between 5 and 8 °C.
Te najvišje dovoljene vsebnosti v kuhanih kozicah v slanici z vrednostjo pH med 5,6 in 5,7 bi morale zadostovati za zaviranje rasti bakterije Listeria monocytogenes pri temperaturah hlajenja med 5 in 8 °C.
However, small changes in the preserving parameters can result in growth of Listeria monocytogenes.
Vendar lahko že majhne spremembe parametrov konzerviranja povzročijo rast bakterije Listeria monocytogenes.
A mathematical predictive method has been developed at the Technological University of Denmark, to determine which level of benzoic acid benzoate (E 210-213) is needed [3].
Na tehnološki univerzi na Danskem so razvili matematično metodo predvidevanja, da bi določili, kakšna vsebnost benzojske kisline – benzoatov (E 210–213) je potrebna [3].
According to that model the level of 1000 mg/kg of E 210-213 is not sufficient to prevent growth of Listeria monocytogenes in shrimps in brine at pH 5,8.
Po navedenem modelu vsebnost 1000 mg/kg E 210–213 ne zadošča za preprečitev rasti bakterije Listeria monocytogenes v kozicah v slanici pri vrednosti pH 5,8.
In order to prevent growth of Listeria monocytogenes in these shrimps, both the model and tests show that the optimal combination of benzoic acid — benzoates (E 210-213) and sorbic acid — sorbates (E 200-203) is 1500 mg/kg and 500 mg/kg respectively.
Model in testiranja kažejo, da je najboljša kombinacija benzojske kisline – benzoatov (E 210–213) in sorbinske kisline – sorbatov (E 200–203) za preprečitev rasti bakterije Listeria monocytogenes v teh kozicah 1500 mg/kg oziroma 500 mg/kg.
In its report trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2012 [4], the European Food Safety Authority (the Authority) concluded that the number of listeriosis cases in humans increased slightly compared with 2011, and 1642 confirmed human cases were reported in 2012.
V svojem poročilu o trendih in virih zoonoz, njihovih povzročiteljih in izbruhih okužb, ki se prenašajo s hrano, v letu 2012 [4] je Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) ugotovila, da se je v primerjavi z letom 2011 število primerov listerioze pri ljudeh rahlo povečalo, pri čemer je bilo leta 2012 prijavljenih 1642 potrjenih primerov pri ljudeh.
A statistically significant increasing trend in the Union was observed over the period 2008-2012, though only slowly increasing, along with a seasonal pattern.
V obdobju 2008–2012 je bilo v Uniji ugotovljeno sicer počasno, a statistično pomembno povečevanje števila okužb, s sezonskim vzorcem.
As in previous years, a high fatality rate (17,8 %) was reported among the cases.
Tako kot v preteklih letih je bila med primeri prijavljena visoka smrtnost (17,8 %).
A total of 198 deaths due to listeriosis were reported by 18 Member States in 2012, which was the highest number of fatal cases reported since 2006.
Leta 2012 je 18 držav članic skupno prijavilo 198 primerov smrti zaradi listerioze, kar je največ po letu 2006.
Listeria monocytogenes was seldomly detected above the legal safety limit for ready-to-eat foods at point of retail.
Bakterijo Listeria monocytogenes so redko odkrili v tolikšni meri, da bi presegla dovoljeno varnostno mejo za živila za neposredno uživanje na prodajnih mestih na drobno.
Samples exceeding this limit were most often found in fishery products.
Vzorci, ki so to mejo presegli, so bili najpogosteje ugotovljeni v ribiških proizvodih.
The Commission report on Dietary Food Additive Intake in the European Union [5] concluded that exposure to benzoic acid — benzoates could be up to 96 % of the ADI for young children and 84 % for adults based on the use at maximum permitted levels.
Komisija je v svojem poročilu o vnosu aditivov za živila s hrano v Evropski uniji [5] ugotovila, da bi izpostavljenost benzojski kislini – benzoatom lahko predstavljala do 96 % sprejemljivega dnevnega vnosa za majhne otroke in 84 % za odrasle na podlagi uporabe najvišjih dovoljenih vsebnosti.
At that time a maximum level in cooked shrimps of 2000 mg/kg was set for sorbic acid — sorbates in combination with benzoic acid — benzoates.
Tedaj je bila za sorbinsko kislino – sorbate v kombinaciji z benzojsko kislino – benzoati določena najvišja vsebnost 2000 mg/kg v kuhanih kozicah.
This level was revised by Directive 2006/52/EC of the European Parliament and of the Council [6] when this authorisation was extended to all cooked crustaceans and molluscs, however with a maximum of 1000 mg/kg for benzoic acid — benzoates.
Ta vsebnost je bila spremenjena z Direktivo 2006/52/ES Evropskega parlamenta in Sveta [6], ko so to odobritev razširili na vse kuhane rake in mehkužce, a največ 1000 mg/kg za benzojsko kislino – benzoate.
It is therefore expected that the increase of this level to 1500 mg/kg, only for cooked shrimps in brine, will not lead to additional exposure that would be of safety concern.
Zato se pričakuje, da povišanje te vsebnosti na 1500 mg/kg (samo za kuhane kozice v slanici), ne bo povzročilo dodatne izpostavljenosti, ki bi pomenila tveganje za varnost.
Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health.
V skladu s členom 3(2) Uredbe (ES) št. 1331/2008 mora Komisija za posodobitev seznama Unije aditivov za živila iz Priloge II k Uredbi (ES) št. 1333/2008 zaprositi za mnenje Agencije, razen če zadevna posodobitev ne bo imela učinka na zdravje ljudi.
Since the authorisation of the use of benzoic acid — benzoates (E 210-213) in cooked shrimps preserved in brine constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority.
Ker gre pri odobritvi uporabe benzojske kisline – benzoatov (E 210–213) v kuhanih kozicah, konzerviranih v slanici, za posodobitev navedenega seznama, ki ne bo imela učinka na zdravje ljudi, Komisiji ni treba zaprositi za mnenje Agencije.
Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly.
Zato bi bilo treba Prilogo II k Uredbi (ES) št. 1333/2008 ustrezno spremeniti.
It shall apply from the date of entry into force of this Regulation.
Uporablja se od trenutka začetka veljavnosti te uredbe.
The European Union Summary Report on Trends and Sources of Zoonoses, Zoonotic Agents and Food-borne Outbreaks in 2012, (EFSA Journal 2014;12(2):3547), http://www.efsa.europa.eu/en/efsajournal/doc/3547.pdf
Zbirno poročilo Evropske unije o trendih in virih zoonoz, njihovih povzročiteljih in izbruhih okužb, ki se prenašajo s hrano, v letu 2012, (EFSA Journal 2014;12(2):3547, http://www.efsa.europa.eu/en/efsajournal/doc/3547.pdf.
Directive 2006/52/EC of the European Parliament and of the Council of 5 July 2006 amending Directive 95/2/EC on food additives other than colours and sweeteners and Directive 94/35/EC on sweeteners for use in foodstuffs (OJ L 204, 26.7.2006, p. 10).
PRILOGA
ANNEX
V delu E Priloge II k Uredbi (ES) št. 1333/2008 se v kategorijo živil 09.2 „Predelani ribe in ribiški proizvodi, vključno z mehkužci in raki“ doda naslednji vnos za vnosom za aditiv za živila E 210–213:
In Part E of Annex II to Regulation (EC) No 1333/2008, in the food category 09.2 'Processed fish and fishery products including molluscs and crustaceans', the following entry is added after the entry for food additive E 210-213:
„E 210–213
‘E 210-213
benzojska kislina – benzoati
Benzoic acid — benzoates
samo kuhane kozice v slanici“
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 Articles 18(4) and 19 thereof,
ob upoštevanju Uredbe (ES) št. 1924/2006 Evropskega parlamenta in Sveta z dne 20. decembra 2006 o prehranskih in zdravstvenih trditvah na živilih [1] in zlasti člena 18(4) in člena 19 Uredbe,
Pursuant to Article 13(3) of Regulation (EC) No 1924/2006, Commission Regulation (EU) No 432/2012 [2] was adopted, which establishes a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children's development and health.
V skladu s členom 13(3) Uredbe (ES) št. 1924/2006 je Komisija sprejela Uredbo (EU) št. 432/2012 [2] o seznamu dovoljenih zdravstvenih trditev na živilih, razen trditev, ki se nanašajo na zmanjšanje tveganja za nastanek bolezni ter na razvoj in zdravje otrok.
Regulation (EC) No 1924/2006 provides that applications for authorisations of health claims are to be submitted by food business operators to the national competent authority of a Member State.
Uredba (ES) št. 1924/2006 določa, da morajo nosilci živilske dejavnosti vloge za odobritev zdravstvenih trditev vložiti pri pristojnem nacionalnem organu države članice.
Following an application from Barry Callebaut Belgium NV submitted pursuant to Article 19(1) of Regulation (EC) No 1924/2006 and including a request for protection of proprietary data, the Authority was required to deliver an opinion on the modification of the authorisation of health claim ‘cocoa flavanols help maintain the elasticity of blood vessels, which contributes to normal blood flow’.
Družba Barry Callebaut Belgium NV je v skladu s členom 19(1) Uredbe (ES) št. 1924/2006 vložila vlogo skupaj z zahtevkom za zakonsko zaščito podatkov, Agencija pa je morala pripraviti mnenje o spremembi odobritve zdravstvene trditve „Kakavovi flavanoli pomagajo ohranjati prožnost žil, kar pripomore k normalnemu pretoku krvi“.
That health claim was authorised, pursuant to Article 13(5) of Regulation (EC) No 1924/2006, by Commission Regulation (EU) No 851/2013 [3].
Navedena zdravstvena trditev je bila z Uredbo Komisije (EU) št. 851/2013 [3] odobrena v skladu s členom 13(5) Uredbe (ES) št. 1924/2006.
The applicant requested an extension of the authorised conditions of use of the claim to a high-flavanols (HF) cocoa extract to be consumed in capsules, tablets or added to ‘other foods, including beverages’.
Vložnik je zahteval razširitev odobrenih pogojev uporabe trditve na kakav z visoko vsebnostjo flavanolov, ki naj bi se užival v obliki kapsul, tablet ali kot dodatek „drugim živilom, vključno s pijačami“.
On 5 May 2014, the Commission and the Member States received a scientific opinion from the Authority (Question No EFSA-Q-2013-00832) [4] which concluded that on the basis of the data submitted, a cause and effect relationship had been established between the consumption of cocoa flavanols in the HF cocoa extract (i.e. in capsules or tablets) and the claimed effect.
Komisija in države članice so 5. maja 2014 prejele znanstveno mnenje Agencije (vprašanje št. EFSA-Q-2013-00832) [4], ki je na podlagi predloženih podatkov ugotovila, da je vzročno-posledična povezava med uživanjem kakaovovih flavanolov v izvlečku kakava z visoko vsebnostjo flavanolov (tj. v kapsulah ali tabletah) in navedeno trditvijo utemeljena.
The Authority indicated in its opinion that its conclusions could not have been reached without considering one human intervention study claimed by the applicant as proprietary.
Agencija je v svojem mnenju navedla, da do ugotovitev ne bi prišla brez upoštevanja intervencijske študije na ljudeh, za katero je vložnik zahteval zakonsko zaščito podatkov [5].
[5]
Komisija je ocenila vse upravičljive informacije, ki jih je predložil vložnik, in sklenila, da so zahteve iz člena 21(1) Uredbe (ES) št. 1924/2006 izpolnjene za študijo, za katero je vložnik zahteval zakonsko zaščito podatkov.
All the justifiable information provided by the applicant has been assessed by the Commission and it is considered that the requirements laid down in Article 21(1) of Regulation (EC) No 1924/2006 are fulfilled for the study claimed as proprietary.
Znanstveni podatki in druge informacije iz navedene študije v skladu s pogoji iz člena 21(1) Uredbe (ES) št. 1924/2006 se zato ne smejo uporabiti v prid poznejšega vložnika v petih letih od datuma začetka veljavnosti te uredbe.
Accordingly, the scientific data and other information included in that study may not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation, under the conditions laid down in Article 21(1) of Regulation (EC) No 1924/2006.
Eden od ciljev Uredbe (ES) št. 1924/2006 je zagotoviti, da so zdravstvene trditve resnične, jasne, zanesljive in uporabne za potrošnika ter da se pri tem upoštevata besedilo in predstavitev trditve.
One of the objectives of Regulation (EC) No 1924/2006 is to ensure that health claims are truthful, clear and reliable and useful to the consumer, and that the wording and the presentation are taken into account in that respect.
Kadar ima besedilo trditev, ki ga uporabi vložnik, za potrošnike enak pomen kot odobrena zdravstvena trditev, ker predstavljata isto povezavo med kategorijo živila, živilom ali njegovo sestavino in zdravjem, bi bilo treba te trditve uporabljati pod enakimi pogoji uporabe, kot so navedeni v Prilogi k tej uredbi.
Therefore, where the wording of claims used by the applicant 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 as those listed in the Annex to this Regulation.
V skladu s členom 20 Uredbe (ES) št. 1924/2006 bi bilo treba register prehranskih in zdravstvenih trditev, ki vsebuje vse odobrene zdravstvene trditve, posodobiti, da se upošteva ta uredba.
In accordance with Article 20 of Regulation (EC) No 1924/2006, the Register of nutrition and health claims containing all authorised health claims should be updated in order to take into account this Regulation.
Ker je vložnik zahteval zakonsko zaščito podatkov, je primerno, da se uporaba te trditve omeji v korist vložnika za obdobje pet let.
Since the applicant claims protection of proprietary data, it is considered appropriate to restrict the use of this claim in favour of the applicant for a period of five years.
Vendar odobritev te trditve, ki je omejena za uporabo posameznega nosilca dejavnosti, ne bi smela drugim vložnikom preprečevati, da zaprosijo za odobritev uporabe iste trditve v primeru, da vloga temelji na podatkih in študijah, ki niso zaščitene v skladu s členom 21 Uredbe (ES) št. 1924/2006.
However, the authorisation of this claim restricted for the use of an individual operator should not prevent other applicants from applying for authorisation to use the same claim in case the application is based on data and studies other than those protected under Article 21 of Regulation (EC) No 1924/2006.
Pri določanju ukrepov iz te uredbe so bile upoštevane pripombe, ki jih je vložnik poslal Komisiji v skladu s členom 16(6) Uredbe (ES) št. 1924/2006.