PROVÁDĚCÍ XXXXXXXX XXXXXX (XX) 2024/221
xx xxx 12.&xxxx;xxxxx 2024
x&xxxx;xxxxxxxx povolení xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxx XXXX 74444&xxxx;xxxx xxxxxxxxx xxxxx xxx xxxxx xxxxx xxxxx xxxxxxx, xxxxxxx druhy drůbeže xxxxxx ke snášce x&xxxx;xxxxxxxxx selata (xxxxxxx xxxxxxxx: XXX Nutritional Xxxxxxxx) x&xxxx;x&xxxx;xxxxx xxxxxxxxxxx xxxxxxxx (EU) x.&xxxx;403/2013
(Xxxx x&xxxx;xxxxxxxx xxx EHP)
EVROPSKÁ XXXXXX,
x&xxxx;xxxxxxx na Xxxxxxx x&xxxx;xxxxxxxxx Evropské xxxx,
x&xxxx;xxxxxxx xx xxxxxxxx Evropského xxxxxxxxxx a Rady (XX) x.&xxxx;1831/2003 xx xxx 22.&xxxx;xxxx&xxxx;2003 x&xxxx;xxxxxxxxxxx xxxxxxx xxxxxxxxxxx ve xxxxxx xxxxxx&xxxx;(1), x&xxxx;xxxxxxx na xx.&xxxx;9 xxxx.&xxxx;2 xxxxxxxxx xxxxxxxx,
xxxxxxxx k těmto xxxxxxx:
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(1) |
Xxxxxxxx (XX) x.&xxxx;1831/2003 stanoví xxxxxxxx doplňkových látek xxxxxxxxxxx ve xxxxxx xxxxxx x&xxxx;xxxxxx x&xxxx;xxxxxxx, xx jejichž xxxxxxx xx povolení xxxxxxx x&xxxx;xxxxxxxx. |
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(2) |
Xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx z Trichoderma reesei XXXX 74444 byl xxxxxxx xx xxxxx xxx xxxx doplňková xxxxx xxx xxxxx xxxxxxx, xxxxxxx x&xxxx;xxx xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxx Komise (XX) x.&xxxx;403/2013&xxxx;(2). |
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(3) |
X&xxxx;xxxxxxx x&xxxx;xx.&xxxx;14 xxxx.&xxxx;1 xxxxxxxx (XX) x.&xxxx;1831/2003 xxxx xxxxxx xxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx reesei XXXX 74444&xxxx;xxxx xxxxxxxxx látky. Xxxxxxx žádost xxxx xxxxxx xxxxx s údaji x&xxxx;xxxxxxxxx požadovanými podle xx.&xxxx;14 xxxx.&xxxx;2 nařízení (XX) č. 1831/2003. |
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(4) |
Evropský xxxx xxx bezpečnost xxxxxxxx (xxxx jen „xxxx“) xxxxxx xx svém xxxxxxxxxx xx dne 11.&xxxx;xxxxxx&xxxx;2023&xxxx;(3) x&xxxx;xxxxxx, xx xxxxxxxxx z endo–1,4-beta-xylanázy, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxx XXXX 74444 xx xx xxxxxxxxxxx xxxxxxxxxx xxxxxxxx použití x&xxxx;xxxxxx xxxxxxxx pro xxxxx xxxxxxx, xxxxxxx x&xxxx;xxx xxxxxxxxx xxxxxx, xxxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxxxx. Xxxx xxxxxx xxxxxx x&xxxx;xxxxxx, xx xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxx ATCC 74444 xx xxx být xxxxxxxxx xx látku xxxxxxxxxxx xxxxxxxxxxxxxxx dýchací xxxxx. Vzhledem x&xxxx;xxxx, xx xxxxxx x&xxxx;xxxxxxxxx xxxxx, xxxxx xxxx xxxxxxx xxxxxxx závěr xxxxxxx xxxxxxxxxx uvedeného xxxxxxxxx způsobit xxxxxxxxxx xxxx a očí xxxx xxxxxxxxxxxxx xxxx. Xxxx xxxxxx xxxxx, že x&xxxx;xxxxxxxxxxx s obnovením povolení xxxx xxxxx posuzovat xxxxxxxx xxxxxxxxx z endo–1,4-beta-xylanázy, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxx XXXX 74444. Xxxx nepovažoval xxxxxxxx xxxxxxxxx xx xxxxxxxxxxxx xx xxxxxxx xx xxx xx xxxxx. Xxxx xxxx ověřil xxxxxx x&xxxx;xxxxxxxx xxxxxxx xxxxxxxxx látky přidané xx krmiv předloženou xxxxxxxxxx xxxxxxxxxx, xxxxxxxx xxxxxxxxx (XX) x.&xxxx;1831/2003. |
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(5) |
Xxxxxxxx x&xxxx;xxxx uvedeným xxxxxxxxxxxx xx Komise xxxxxxx, xx xxxxxxxxx z endo–1,4-beta-xylanázy, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxx ATCC 74444 xxxxxxx xxxxxxxx xxxxxxxxx x&xxxx;xxxxxx&xxxx;5 xxxxxxxx (ES) x.&xxxx;1831/2003. Xxxxx by xxxxxxxx xxxxxxx doplňkové xxxxx xxxx být xxxxxxxx. Vedle toho xx Xxxxxx xxxxxxx, xx xx měla xxx xxxxxxx xxxxxx xxxxxxxx xxxxxxxx, aby xx xxxxxxxxx nepříznivým xxxxxxx xx xxxxxx xxxxxxxxx dané xxxxxxxxx xxxxx. |
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(6) |
X&xxxx;xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxx XXXX 74444 jako doplňkové xxxxx xx mělo xxx změněno prováděcí xxxxxxxx (XX) x.&xxxx;403/2013. |
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(7) |
Xxxxxxxx x&xxxx;xxxx, xx xxxxxxxxxxxx xxxxxx nevyžadují xxxxxxxx xxxxxxxxx xxxx x&xxxx;xxxxxxxxxx xxx xxxxxxxx přípravku x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxx XXXX 74444, xx xxxxxx xxxxxxxx xxxxxxxxx xxxxxx, xxxxx by xxxxxxxxxxx xxxxxxx xxxxxxxx xxxxxxxxx xx xx xxxxxx xxxxxx xxxxxxxxx vyplývajících x&xxxx;xxxxxxxx xxxxxxxx. |
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(8) |
Xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx jsou x&xxxx;xxxxxxx se xxxxxxxxxxx Xxxxxxx xxxxxx pro xxxxxxxx, zvířata, xxxxxxxxx x&xxxx;xxxxxx, |
XXXXXXX XXXX NAŘÍZENÍ:
Xxxxxx&xxxx;1
Xxxxxxxx povolení
Povolení xxxxxxxxx xxxxxxxxx x&xxxx;xxxxxxx, náležejícího xx xxxxxxxxx xxxxxxxxxxx xxxxx „xxxxxxxxxxxx xxxxxxxxx xxxxx“ x&xxxx;xxxxxxx skupiny „xxxxx zvyšující xxxxxxxxxxxxx“, xx xxxxxxxx podle xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxx.
Xxxxxx&xxxx;2
Xxxxx xxxxxxxxxxx xxxxxxxx (XX) x.&xxxx;403/2013
Xxxxxxxxx xxxxxxxx (XX) x.&xxxx;403/2013 xx xxxx takto:
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1. |
článek 1 se xxxxxxx; |
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2. |
xxxxxxx xx xxxxxxx. |
Xxxxxx&xxxx;3
Xxxxxxxxx xxxxxxxx
1.&xxxx;&xxxx;&xxxx;Xxxxxxxxx xxxxxxx x&xxxx;xxxxxxx x&xxxx;xxxxxxx xxxxxxxxxx xxxxx xxxxxxxxx, xxxxxxxx x&xxxx;xxxxxxxx před xxxx 4.&xxxx;xxxxx 2024 x&xxxx;xxxxxxx x&xxxx;xxxxxxxx platnými xxxx xxxx 4. února 2024, xxxxx být nadále xxxxxxx na trh x&xxxx;xxxxxxxxx až do xxxxxxxxx xxxxxxxxxxx zásob.
2. Krmné xxxxx x&xxxx;xxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxx x&xxxx;xxxxxxx, xxxxxxxx x&xxxx;xxxxxxxx xxxx 4. únorem 2025 x&xxxx;xxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx 4. xxxxxx 2024, xxxxx xxx xxxxxxx na xxx x&xxxx;xxxxxxxxx až xx vyčerpání xxxxxxxxxxx xxxxx.
Článek 4
Vstup v platnost
Toto nařízení xxxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx xx xxxxxxxxx x&xxxx;Xxxxxxx xxxxxxxx Xxxxxxxx xxxx.
Xxxx xxxxxxxx xx xxxxxxx v celém xxxxxxx x&xxxx;xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx xxxxxxx.
X&xxxx;Xxxxxxx xxx 12. ledna 2024.
Xx Xxxxxx
xxxxxxxxxxx
Xxxxxx XXX DER XXXXX
(1)&xxxx;&xxxx; Úř. věst. L 268, 18.10.2003, x.&xxxx;29.
(2)&xxxx;&xxxx;Xxxxxxxxx nařízení Komise (XX) x.&xxxx;403/2013 xx xxx 2.&xxxx;xxxxxx&xxxx;2013 x&xxxx;xxxxxxxx xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxx (XXXX 74444) jako xxxxxxxxx xxxxx pro xxxxx drůbeže, xxxxxxx x&xxxx;xxx xxxxxxxxx xxxxxx x&xxxx;xxxxxx xx xxxx xxxxxxxx (ES) x.&xxxx;1259/2004, (XX) x.&xxxx;1206/2005 x&xxxx;(XX) x.&xxxx;1876/2006 (xxxxxxx xxxxxxxx XXX Xxxxxxxxxxx Xxxxxxxx) (Xx.&xxxx;xxxx.&xxxx;X&xxxx;121, 3.5.2013, s. 26).
(3) XXXX Journal 2023;21(6):8043.
XXXXXXX
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Xxxxxxxxxxxxx xxxxx doplňkové xxxxx |
Xxxxx držitele povolení |
Doplňková xxxxx |
Xxxxxxx, xxxxxxxx xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx kategorie xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx obsah |
Jiná xxxxxxxxxx |
Xxxxx platnosti povolení |
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Jednotky xxxxxxxx/xx xxxxxxxxxxx xxxxxx x&xxxx;xxxxxx xxxxxxxx 12&xxxx;% |
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Xxxxxxxxx: xxxxxxxxxxxx xxxxxxxxx xxxxx. Xxxxxxx xxxxxxx: xxxxx xxxxxxxxx stravitelnost. |
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4a1602i |
DSM Xxxxxxxxxxx Xxxxxxxx |
Xxxx–1,4-xxxx-xxxxxxxx (XX 3.2.1.8) Xxxx–1,3(4)-xxxx-xxxxxxxxx (XX 3.2.1.6) Xxxx–1,4-xxxx-xxxxxxxxx (XX 3.2.1.4) |
Xxxxxxx xxxxxxxxx xxxxx Xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx reesei ATCC 74444 x&xxxx;xxxxxxx aktivity xxx:
Xxxxxxx xxxx xxxxx xxxxx. Xxxxxxxxxxxxxxx účinné xxxxx Xxxx–1,4-xxxx-xxxxxxxx (XX 3.2.1.8), xxxx–1,4-xxxx-xxxxxxxxx (XX 3.2.1.6) x&xxxx;xxxx–1,3(4)-xxxx-xxxxxxxxx (XX 3.2.1.4) x&xxxx;Xxxxxxxxxxx xxxxxx ATCC 74444 Xxxxxxxxxx xxxxxx&xxxx; (4)
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Xxxxx všech xxxxx xxxxxxx kromě výkrmu xxxx |
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Xxxx–1,4-xxxx-xxxxxxxx: 135 U Endo–1,3(4)-beta-glukanáza: 35 U Endo–1,4-beta-glukanáza: 40 X |
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4.&xxxx;xxxxx 2034 |
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Xxxxxxx druhy xxxxxxx xxxxxx ke xxxxxx |
Xxxx–1,4-xxxx-xxxxxxxx: 216 X Xxxx–1,3(4)-xxxx-xxxxxxxxx: 56 U Endo–1,4-beta-glukanáza: 64 X |
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Xxxxx xxxx Xxxxxx (odstavená) |
Endo–1,4-beta-xylanáza: 270 X Xxxx–1,3(4)-xxxx-xxxxxxxxx: 70 X Xxxx–1,4-xxxx-xxxxxxxxx: 80 X |
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(1)&xxxx;&xxxx;Xxxxx xxxxxxxx (X) xxxx-1,4-xxxx-xxxxxxxx xx xxxxxxxx xxxxxx, xxxxx uvolní 1 xxxxxxxxx xxxxxxxxxxxx xxxxx (xxxxxxxxxx xxxxxx) xx xxxxxx z pšeničného arabinoxylanu xxx xxxxxxx 40&xxxx;°X&xxxx;x&xxxx;xX&xxxx;5,0.
(2)&xxxx;&xxxx;Xxxxx xxxxxxxx (X) endo-1,3(4)-beta-glukanázy xx xxxxxxxx xxxxxx, xxxxx xxxxxx 1 xxxxxxxxx xxxxxxxxxxxx xxxxx (xxxxxxxxxx glukózy) za xxxxxx z ječného xxxx-xxxxxxx xxx xxxxxxx 40 °C a pH 5,0.
(3) Jedna xxxxxxxx (X) endo-1,4-beta-glukanázy xx xxxxxxxx enzymu, xxxxx uvolní 1 xxxxxxxxx xxxxxxxxxxxx cukru (xxxxxxxxxx xxxxxxx) xx xxxxxx x&xxxx;xxxxxxxxxxxxxxxxxxxxx při xxxxxxx 40&xxxx;°X&xxxx;x&xxxx;xX&xxxx;5,0.
(4)&xxxx;&xxxx;Xxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxxxxx xxxxxxxx xxx xxxxxx xx internetové xxxxxxx referenční xxxxxxxxxx: xxxxx://xxxxx-xxxxxxxx-xxxxxx.xx.xxxxxx.xx/xxxx-xx-xxxx-xxxx-xxxxxxxxx/xxxx-xx-xxxxxxxxxxxxx/xxxx-xx-xxxxxxxxxx-xxxxxxx_xx.