XXŘ&Xxxxxx;XXX&Xxxxxx; KOMISE (EU) 2016/1412
xx xxx 24. xxxxx 2016
x&xxxx;xxxxxx&xxxxxx;xxx&xxxxxx; xxčxx&xxxxxx;xx xxxxxxxx&xxxxxx;xx xxxxxx&xxxxxx; xřx xxxxčxx&xxxxxx;x&xxxxxx; potravin, xxž xx x&xxxxxx;x&xxxxxx; xx&xxxxxx;žxx&xxxxxx; xxxxxx xxxxxxxěx&xxxxxx;
(Xxxx s x&xxxxxx;xxxxxx pro XXX)
XXXXXXX&Xxxxxx; XXXXXX,
x&xxxx;xxxxxxx xx Xxxxxxx x&xxxx;xxxxxx&xxxxxx;x&xxxxxx; Xxxxxxx&xxxxxx; unie,
x&xxxx;xxxxxxx xx nařízení Xxxxxxx&xxxxxx;xx xxxxxxxxxx x&xxxx;Xxxx (XX) č.&xxxx;1924/2006 xx dne 20.&xxxx;xxxxxxxx&xxxx;2006 o výživových x&xxxx;xxxxxxxx&xxxxxx;xx xxxxxx&xxxxxx;xx xřx xxxxčxx&xxxxxx;x&xxxxxx; xxxxxxxx (1), a zejména na čx.&xxxx;17 xxxx.&xxxx;3 xxxxxx&xxxxxx;xx xxř&xxxxxx;xxx&xxxxxx;,
xxxxxxxx x&xxxx;xěxxx xůxxxůx:
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(1) |
Xxxxx xxř&xxxxxx;xxx&xxxxxx; (XX) č.&xxxx;1924/2006 xxxx xxxxxxxx&xxxxxx; tvrzení xřx xxxxčxx&xxxxxx;x&xxxxxx; xxxxxxxx xxx&xxxxxx;x&xxxxxx;xx, pokud xx Xxxxxx v souladu x&xxxx;xxxxxx&xxxxxx;x xxř&xxxxxx;xxx&xxxxxx;x xxxxxx&xxxxxx;x&xxxxxx; a nezařadí xx xxxxxx xxxx&xxxxxx;xxx&xxxxxx;xx xxxxxx&xxxxxx;. |
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(2) |
Xxř&xxxxxx;xxx&xxxxxx; (XX) č.&xxxx;1924/2006 xxxxěž xxxxxx&xxxxxx;, že xxxxxxxxxxxx&xxxxxx; xxxxxxxx&xxxxxx;řxx&xxxxxx;xx xxxxxxů xxxxx podávat žádosti x&xxxx;xxxx&xxxxxx;xxx&xxxxxx; zdravotních xxxxxx&xxxxxx; x&xxxx;xř&xxxxxx;xxx&xxxxxx;x&xxxxxx;xx xxxxxxxx&xxxxxx;xx&xxxxxx;xx orgánu čxxxxx&xxxxxx;xx xx&xxxxxx;xx. Xř&xxxxxx;xxx&xxxxxx;x&xxxxxx; xxxxxxxx&xxxxxx;xx&xxxxxx; xxx&xxxxxx;x postoupí xxxxx&xxxxxx; ž&xxxxxx;xxxxx Xxxxxxx&xxxxxx;xx &xxxxxx;řxxx pro xxxxxčxxxx xxxxxxxx (XXXX, x&xxxxxx;xx xxx &xxxxx;&xxxxxx;řxx&xxxxx;). |
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(3) |
Jakmile úřad ž&xxxxxx;xxxx xxxxž&xxxxxx;, neprodleně x&xxxx;xxx xxěxxx&xxxxxx; xxxxxx&xxxxxx; čxxxxx&xxxxxx; xx&xxxxxx;xx x&xxxx;Xxxxxx x&xxxx;x&xxxx;xxxčxx&xxxxxx;xx xxxxxxxx&xxxxxx;xx xxxxxx&xxxxxx; xxx&xxxxxx; xx&xxxxxx; xxxxxxxxxx. |
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(4) |
Xxxxxx xxxxxxxx o schválení xxxxxxxx&xxxxxx;xx xxxxxx&xxxxxx; x&xxxx;xxxxxxx xx xxxxxxxxxx úřadu. |
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(5) |
X&xxxx;x&xxxxxx;xxxxxxxx xx ž&xxxxxx;xxxx xxxxxčxxxxx Xxx-Xxxxxxxxxxx XxxX xřxxxxžxxxx xxxxx čx.&xxxx;14 odst. 1 x&xxxxxx;xx. x) xxř&xxxxxx;xxx&xxxxxx; (XX) č.&xxxx;1924/2006 byl &xxxxxx;řxx xxž&xxxxxx;x&xxxxxx;x x&xxxx;xxx&xxxxxx;x&xxxxxx; xxxxxxxxxx xx xxxxxxxx&xxxxxx;xx xxxxxx&xxxxxx; x&xxxxxx;xxx&xxxxxx;x&xxxxxx;xx xx přípravku Xxxxxxxxx&xxx; x&xxxx;xx&xxxxxx;žxx&xxxxxx; xxxxx&xxxxxx;xx xxxxx a omezení xxxxxx xxxxxxxxxx (xx&xxxxxx;xxx č.&xxxx;XXXX-X-2014-00366 (2)). Xxxxxxxxx&xxxxxx; xxxxxx&xxxxxx; xxxxxxxxxxx žxxxxxx takto: „Symbiosal xxxxxxxxxxxě xxxžxxx xx&xxxxxx;&xxxxxx;xx&xxxxxx; xxxxx&xxxxxx; tlak, xxxxx xx xxxž&xxxxxx;x&xxxxxx; xxxx x&xxxxxx;xxxxx xxxxxčx&xxxxxx; xxxxx&xxxxxx; xxxx. Zvýšení krevního xxxxx xx xxxxxxx&xxxxxx;x xxxxxxxx xxx xxxxxxxxxx&xxxxx;. |
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(6) |
Xxx 1.&xxxx;čxxxxxxx&xxxx;2015 obdržela Komise x&xxxx;čxxxxx&xxxxxx; xx&xxxxxx;xx xěxxxx&xxxxxx; xxxxxxxxxx &xxxxxx;řxxx, xx xxxx&xxxxxx;x &xxxxxx;řxx xxxxěx x&xxxx;x&xxxxxx;xěxx, žx na x&xxxxxx;xxxxě xřxxxxžxx&xxxxxx;xx údajů xxxxx xxx&xxxxxx;xěx xř&xxxxxx;čxxx&xxxxxx; xxxxx mezi xž&xxxxxx;x&xxxxxx;x&xxxxxx;x xř&xxxxxx;xxxxxx Xxxxxxxxx&xxx; x&xxxxxx;xxx xxxxx&xxxxxx; xxxx x&xxxx;xx&xxxxxx;žxx&xxxxxx;x xxxxx&xxxxxx;xx tlaku. Xxxxxxxx x&xxxx;xxxx, že xxx&xxxxxx; xxxxxx&xxxxxx; xxxxxxx&xxxxxx;x&xxxxxx; xxžxxxxxůx xxxxxxxx&xxxxxx;x x&xxxx;xxř&xxxxxx;xxx&xxxxxx; (ES) č.&xxxx;1924/2006, nemělo by x&xxxxxx;x xxxx&xxxxxx;xxxx. |
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(7) |
Xxxxřxx&xxxxxx; xxxxxxxx&xxxxxx; x&xxxxxx;xxx nařízením xx x&xxxx;xxxxxxx se xxxxxxxxxxx Xx&xxxxxx;x&xxxxxx;xx x&xxxxxx;xxxx xxx xxxxxxxx, xx&xxxxxx;řxxx, xxxxxxxxx x&xxxx;xxxxxx, |
XŘXXXXX TOTO XXŘ&Xxxxxx;XXX&Xxxxxx;:
Čx&xxxxxx;xxx&xxxx;1
Xxxxxxxx&xxxxxx; xxxxxx&xxxxxx; xxxxxx&xxxxxx; x&xxxx;xř&xxxxxx;xxxx xxxxxx xxř&xxxxxx;xxx&xxxxxx; xx xxxxřxx&xxxxxx; xx xxxxxx schválených tvrzení xxxxx&xxxxxx;xx xxx Xxxx xxxxxxxx&xxxxxx; x&xxxx;čx.&xxxx;14 xxxx.&xxxx;1 xxř&xxxxxx;xxx&xxxxxx; (XX) č.&xxxx;1924/2006.
Čx&xxxxxx;xxx&xxxx;2
Xxxx xxř&xxxxxx;xxx&xxxxxx; vstupuje x&xxxx;xxxxxxxx xxxx&xxxxxx;x&xxxxxx;x xxxx xx vyhlášení x&xxxx;&Xxxxxx;řxxx&xxxxxx;x xěxxx&xxxxxx;xx Xxxxxxx&xxxxxx; unie.
Xxxx xxxxxxxx je xxxxxxx x&xxxx;xxxxx rozsahu x&xxxx;xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx státech.
V Bruselu xxx 24. srpna 2016.
Xx Xxxxxx
xxxxxxxx
Xxxx-Xxxxxx XXXXXXX
(1)&xxxx;&xxxx;Xx. xxxx. L 404, 30.12.2006, x.&xxxx;9.
(2)&xxxx;&xxxx;XXXX Xxxxxxx 2015; 13(7):4147.
PŘÍLOHA
Zamítnuté zdravotní tvrzení
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Žádost – xxxxxxxxx xxxxxxxxxx xxxxxxxx (ES) x.&xxxx;1924/2006 |
Xxxxxx, xxxxx, xxxxxxxxx nebo xxxxxxxxx xxxxxxxx |
Xxxxxxx |
Xxxxxxxxxx xxxxx xxxxxxxxxx XXXX |
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Xxxxxxxxx xxxxxxx x&xxxx;xxxxxxx rizika xxxxxxxxxx xxxxx xx.&xxxx;14 odst. 1 xxxx. x) |
Xxxxxxxxx® |
Xxxxxxxxx xxxxxxxxxxxx xxxxxxx xxxxxxx xxxxxx xxxx, pokud se xxxxxxx xxxx xxxxxxx xxxxxxxx stolní soli. Xxxxxxx krevního xxxxx xx xxxxxxxxx xxxxxxxx xxx xxxxxxxxxx |
X-2014-00366 |