XXXXXXXXX XXXXXXXX KOMISE (XX) 2021/508
xx dne 23.&xxxx;xxxxxx 2021
x&xxxx;xxxxxxxx povolení xxxxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx XXXX 39885&xxxx;xxxx doplňkové xxxxx pro xxxxxxxxx xxxxxx x&xxxx;x&xxxx;xxxxx xxxxxxxx (XX) x.&xxxx;170/2011 (držitel xxxxxxxx: Prosol X.x.X.)
(Xxxx x&xxxx;xxxxxxxx pro XXX)
XXXXXXXX XXXXXX,
x&xxxx;xxxxxxx xx Xxxxxxx x&xxxx;xxxxxxxxx Xxxxxxxx xxxx,
x&xxxx;xxxxxxx xx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;1831/2003 ze xxx 22.&xxxx;xxxx&xxxx;2003 x&xxxx;xxxxxxxxxxx xxxxxxx xxxxxxxxxxx ve xxxxxx xxxxxx&xxxx;(1), x&xxxx;xxxxxxx xx xx.&xxxx;9 xxxx.&xxxx;2 xxxxxxxxx xxxxxxxx,
xxxxxxxx x&xxxx;xxxxx xxxxxxx:
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(1) |
Xxxxxxxx (XX) x.&xxxx;1831/2003 xxxxxxx xxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxx ve výživě xxxxxx x&xxxx;xxxxxx x&xxxx;xxxxxxx, xx jejichž xxxxxxx xx xxxxxxxx uděluje x&xxxx;xxxxxxxx. |
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(2) |
Xxxxxxxxx Saccharomyces xxxxxxxxxx XXXX 39885 byl xxxxxxxxx Xxxxxx (XX) x.&xxxx;170/2011&xxxx;(2) xxxxxxx na xxxx 10 xxx xxxx xxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxx. |
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(3) |
X&xxxx;xxxxxxx x&xxxx;xx.&xxxx;14 xxxx.&xxxx;1 xxxxxxxx (XX) x.&xxxx;1831/2003 podal xxxxxxx xxxxxxxxx xxxxxxxx xxxxxx x&xxxx;xxxxxxxx povolení xxxxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx XXXX 39885 jako xxxxxxxxx xxxxx xxx odstavená xxxxxx, xxxxxxx požádal x&xxxx;xxxxxxxx xxxxxxx xxxxxxxxx xxxxx do xxxxxxxxx xxxxxxxxxxx xxxxx „xxxxxxxxxxxx xxxxxxxxx xxxxx“. Xxxxxxx xxxxxx xxxx podána xxxxx x&xxxx;xxxxx x&xxxx;xxxxxxxxx xxxxxxxxxxxx podle xx.&xxxx;14 xxxx.&xxxx;2 xxxxxxxxx xxxxxxxx. |
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(4) |
Xxxxxxxx xxxx xxx xxxxxxxxxx xxxxxxxx (xxxx jen „xxxx“) xxxxxx xx xxxx xxxxxxxxxx xx xxx 30.&xxxx;xxxx&xxxx;2020&xxxx;(3) x&xxxx;xxxxxx, xx žadatel xxxxxxxxx xxxxxx, že uvedená xxxxxxxxx xxxxx xxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxx. Xxxx xxxxxx x&xxxx;xxxxxx, xx xxxxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx MUCL 39885 xxxx nepříznivé xxxxxx xx xxxxxx xxxxxx, xxxxxxxxxx xxxxxxxxxxxx xxx xx životní xxxxxxxxx. Xxxxxxxxxxx rovněž, xx xxxxxxx xxxxxxxxx xx xxxxxxxxx xx xxxxx, xxxxx může xxxxxxxxxx xxxxxxxxxx xxxx x&xxxx;xxx, x&xxxx;xx xxxxxxxxxxx xxxxxxxxxxxxxx xxxx x&xxxx;xxxxxxxxx xxxx. Xxxxxx xx xxxxx xxxxxxx, xx by xxxx být xxxxxxx xxxxxx ochranná xxxxxxxx, xxx xx zabránilo xxxxxxxxxxx xxxxxxx xx xxxxxx xxxxxx, xxxxxxx xxxxx jde x&xxxx;xxxxxxxxx xxxxxxx doplňkové xxxxx. Xxxx xxxx xxxxxx xxxxxx o metodách xxxxxxx xxxxxxxxx xxxxx přidané xx krmiv, xxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxx (ES) x.&xxxx;1831/2003. |
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(5) |
Xxxxxxxxx přípravku Xxxxxxxxxxxxx xxxxxxxxxx XXXX 39885 xxxxxxxxx, xx xxxxxxxx xxx povolení xxxxxxxxx x&xxxx;xxxxxx&xxxx;5 xxxxxxxx (XX) x.&xxxx;1831/2003 xxxx splněny. Xxxxx xx xxxxxxxx xxxxxxx xxxxxxxxx xxxxx xxxx xxx obnoveno. |
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(6) |
V důsledku xxxxxxxx xxxxxxxx xxxxxxxxx Xxxxxxxxxxxxx cerevisiae MUCL 39885&xxxx;xxxx xxxxxxxxx xxxxx xx nařízení (XX) x.&xxxx;170/2011 xxxx xxx xxxxxxx. |
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(7) |
Xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxx v souladu xx xxxxxxxxxxx Xxxxxxx xxxxxx xxx xxxxxxxx, xxxxxxx, xxxxxxxxx x&xxxx;xxxxxx, |
XXXXXXX XXXX XXXXXXXX:
Xxxxxx&xxxx;1
Xxxxxxxx xxxxxxxxx uvedeného x&xxxx;xxxxxxx, xxxxxxxxxxxx xx xxxxxxxxx xxxxxxxxxxx xxxxx „xxxxxxxxxxxx xxxxxxxxx látky“ x&xxxx;xxxxxxx xxxxxxx „xxxxxxxxxxxxx xxxxxxx xxxxx“, xx xxxxxxxx xxxxx xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxx.
Xxxxxx&xxxx;2
Xxxxxxxx (XX) č. 170/2011 xx xxxxxxx.
Xxxxxx&xxxx;3
Xxxx xxxxxxxx vstupuje x&xxxx;xxxxxxxx xxxxxxxx dnem xx xxxxxxxxx x&xxxx;Xxxxxxx xxxxxxxx Evropské xxxx.
Xxxx nařízení xx xxxxxxx x&xxxx;xxxxx xxxxxxx x&xxxx;xxxxx xxxxxxxxxx ve xxxxx xxxxxxxxx státech.
V Bruselu xxx 23. března 2021.
Xx Xxxxxx
xxxxxxxxxxx
Xxxxxx XXX DER XXXXX
(1)&xxxx;&xxxx;Xx. věst. L 268, 18.10.2003, x.&xxxx;29.
(2)&xxxx;&xxxx;Xxxxxxxx Xxxxxx (XX) x.&xxxx;170/2011 xx xxx 23.&xxxx;xxxxx&xxxx;2011 x&xxxx;xxxxxxxx xxxxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx XXXX 39885&xxxx;xxxx xxxxxxxxx xxxxx xxx xxxxxx (xxxxxxxxx) x&xxxx;x&xxxx;xxxxx xxxxxxxx (XX) č. 1200/2005 (držitel xxxxxxxx Xxxxxx XxX) (Xx. xxxx. X&xxxx;49, 24.2.2011, x.&xxxx;8).
(3)&xxxx;&xxxx;XXXX Xxxxxxx 2020;18(11):6284.
XXXXXXX
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Xxxxxxxxxxxxx xxxxx xxxxxxxxx xxxxx |
Xxxxx držitele povolení |
Doplňková xxxxx |
Xxxxxxx, xxxxxxxx xxxxxx, xxxxx, analytická xxxxxx |
Xxxx xxxx xxxxxxxxx xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxx xxxxxxxxxx |
Xxxxx xxxxxxxxx povolení |
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CFU/kg xxxxxxxxxxx krmiva x&xxxx;xxxxxx xxxxxxxx 12&xxxx;% |
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Xxxxxxxxx: zootechnické xxxxxxxxx xxxxx. Xxxxxxx xxxxxxx: stabilizátory střevní xxxxx. |
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4x1710 |
Xxxxxx X.x.X. |
Xxxxxxxxxxxxx xxxxxxxxxx XXXX 39885 |
Xxxxxxx doplňkové xxxxx Xxxxxxxxx Xxxxxxxxxxxxx cerevisiae XXXX 39885 s obsahem xxxxxxx 1 × 109 CFU/g |
Odstavená xxxxxx |
– |
3 × 109 |
– |
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13.4.2031 |
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Xxxxxxxxxxxxxxx xxxxxx xxxxx: Xxxxxxx buňky Saccharomyces xxxxxxxxxx MUCL 39885 |
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Xxxxxxxxxx xxxxxx&xxxx;&xxxx;(1) Xxxxxxxxx xxxxx xxxxxxxxxxxxxx: xxxxxxxxx na xxxxxxxxxx xxxxx x&xxxx;xxxxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxxxxxxxxx (XXXX) (XX 15789) Xxxxxxxxxxxx: xxxxxxxxxxxx řetězová xxxxxx (PCR) |
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(1) Podrobné xxxxxxxxx x&xxxx;xxxxxxxxxxxx metodách lze xxxxxx xx xxxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxxxxxxx: xxxxx://xx.xxxxxx.xx/xxx/xx/xxxx/xxxx-xxxxxxxxx/xxxxxxxxxx-xxxxxxx