PROVÁDĚCÍ XXXXXXXX XXXXXX (XX) 2024/221
xx dne 12.&xxxx;xxxxx 2024
o obnovení 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 xxxxx druhů drůbeže, xxxxxxx xxxxx xxxxxxx xxxxxx xx xxxxxx x&xxxx;xxxxxxxxx xxxxxx (držitel xxxxxxxx: XXX Xxxxxxxxxxx Xxxxxxxx) a o změně xxxxxxxxxxx xxxxxxxx (XX) x.&xxxx;403/2013
(Xxxx x&xxxx;xxxxxxxx xxx EHP)
EVROPSKÁ XXXXXX,
x&xxxx;xxxxxxx xx Smlouvu x&xxxx;xxxxxxxxx Xxxxxxxx xxxx,
x&xxxx;xxxxxxx xx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;1831/2003 xx dne 22.&xxxx;xxxx&xxxx;2003 x&xxxx;xxxxxxxxxxx látkách xxxxxxxxxxx xx výživě xxxxxx&xxxx;(1), x&xxxx;xxxxxxx xx xx.&xxxx;9 xxxx.&xxxx;2 xxxxxxxxx xxxxxxxx,
xxxxxxxx k těmto xxxxxxx:
(1) |
Xxxxxxxx (XX) č. 1831/2003 xxxxxxx xxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxx xx xxxxxx xxxxxx x&xxxx;xxxxxx a postupy, xx xxxxxxx xxxxxxx xx povolení uděluje x&xxxx;xxxxxxxx. |
(2) |
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 xxx xxxxxxx xx xxxxx xxx jako doplňková xxxxx xxx xxxxx xxxxxxx, nosnice x&xxxx;xxx xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxx Xxxxxx (EU) x.&xxxx;403/2013&xxxx;(2). |
(3) |
X&xxxx;xxxxxxx x&xxxx;xx.&xxxx;14 odst. 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 xxxxxx XXXX 74444&xxxx;xxxx xxxxxxxxx xxxxx. Xxxxxxx xxxxxx xxxx xxxxxx xxxxx x&xxxx;xxxxx x&xxxx;xxxxxxxxx xxxxxxxxxxxx xxxxx xx.&xxxx;14 odst. 2 xxxxxxxx (XX) x.&xxxx;1831/2003. |
(4) |
Xxxxxxxx xxxx xxx bezpečnost xxxxxxxx (xxxx jen „xxxx“) xxxxxx xx xxxx xxxxxxxxxx ze xxx 11.&xxxx;xxxxxx&xxxx;2023&xxxx;(3) k závěru, že 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 xx xx xxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxx x&xxxx;xxxxxx xxxxxxxx xxx xxxxx xxxxxxx, xxxxxxx x&xxxx;xxx xxxxxxxxx selata, 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 a endo–1,4-beta-glukanázy x&xxxx;Xxxxxxxxxxx xxxxxx XXXX 74444 xx xxx xxx xxxxxxxxx xx xxxxx xxxxxxxxxxx xxxxxxxxxxxxxxx dýchací xxxxx. Xxxxxxxx k tomu, xx nejsou k dispozici xxxxx, nebyl xxxx xxxxxxx vyvodit xxxxx xxxxxxx potenciálu uvedeného xxxxxxxxx xxxxxxxx xxxxxxxxxx xxxx a očí nebo xxxxxxxxxxxxx xxxx. Xxxx xxxxxx xxxxx, že x&xxxx;xxxxxxxxxxx x&xxxx;xxxxxxxxx xxxxxxxx xxxx xxxxx xxxxxxxxx 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 ATCC 74444. Xxxx nepovažoval zvláštní xxxxxxxxx na xxxxxxxxxxxx xx xxxxxxx xx xxx xx nutné. Xxxx také xxxxxx xxxxxx x&xxxx;xxxxxxxx xxxxxxx xxxxxxxxx xxxxx přidané xx krmiv xxxxxxxxxxx xxxxxxxxxx xxxxxxxxxx, xxxxxxxx xxxxxxxxx (ES) x.&xxxx;1831/2003. |
(5) |
Xxxxxxxx x&xxxx;xxxx xxxxxxxx xxxxxxxxxxxx xx Xxxxxx xxxxxxx, xx xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx z Trichoderma xxxxxx XXXX 74444 xxxxxxx xxxxxxxx xxxxxxxxx x&xxxx;xxxxxx&xxxx;5 nařízení (XX) x.&xxxx;1831/2003. Xxxxx xx xxxxxxxx uvedené doplňkové xxxxx xxxx xxx xxxxxxxx. Xxxxx toho xx Komise xxxxxxx, xx xx měla xxx xxxxxxx xxxxxx xxxxxxxx opatření, xxx xx xxxxxxxxx xxxxxxxxxxx xxxxxxx xx xxxxxx xxxxxxxxx xxxx doplňkové xxxxx. |
(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 xxxx xxx xxxxxxx xxxxxxxxx xxxxxxxx (EU) x.&xxxx;403/2013. |
(7) |
Xxxxxxxx x&xxxx;xxxx, že bezpečnostní xxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxx xxxx x&xxxx;xxxxxxxxxx xxx 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 reesei XXXX 74444, xx xxxxxx xxxxxxxx xxxxxxxxx období, xxxxx xx zúčastněným xxxxxxx xxxxxxxx připravit xx na plnění xxxxxx xxxxxxxxx xxxxxxxxxxxxx x&xxxx;xxxxxxxx xxxxxxxx. |
(8) |
Xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxx x&xxxx;xxxxxxx xx xxxxxxxxxxx Xxxxxxx výboru pro xxxxxxxx, zvířata, xxxxxxxxx x&xxxx;xxxxxx, |
XXXXXXX XXXX NAŘÍZENÍ:
Xxxxxx&xxxx;1
Xxxxxxxx povolení
Povolení xxxxxxxxx xxxxxxxxx v příloze, xxxxxxxxxxxx xx xxxxxxxxx xxxxxxxxxxx xxxxx „xxxxxxxxxxxx xxxxxxxxx xxxxx“ x&xxxx;xxxxxxx skupiny „xxxxx zvyšující stravitelnost“, xx obnovuje xxxxx xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxx.
Xxxxxx&xxxx;2
Xxxxx xxxxxxxxxxx xxxxxxxx (XX) x.&xxxx;403/2013
Xxxxxxxxx xxxxxxxx (XX) č. 403/2013 xx xxxx xxxxx:
1. |
xxxxxx&xxxx;1 se xxxxxxx; |
2. |
xxxxxxx xx zrušuje. |
Článek 3
Přechodná opatření
1. Přípravek xxxxxxx x&xxxx;xxxxxxx x&xxxx;xxxxxxx xxxxxxxxxx xxxxx xxxxxxxxx, xxxxxxxx x&xxxx;xxxxxxxx xxxx xxxx 4.&xxxx;xxxxx 2024 v souladu x&xxxx;xxxxxxxx platnými před xxxx 4. února 2024, xxxxx být xxxxxx xxxxxxx xx trh x&xxxx;xxxxxxxxx xx xx xxxxxxxxx stávajících xxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxx xxxxx x&xxxx;xxxxx suroviny xxxxxxxxxx přípravek xxxxxxx x&xxxx;xxxxxxx, vyrobené x&xxxx;xxxxxxxx xxxx 4. únorem 2025 x&xxxx;xxxxxxx x&xxxx;xxxxxxxx xxxxxxxx před 4. xxxxxx 2024, xxxxx xxx xxxxxxx xx xxx x&xxxx;xxxxxxxxx xx xx xxxxxxxxx xxxxxxxxxxx xxxxx.
Xxxxxx&xxxx;4
Xxxxx x&xxxx;xxxxxxxx
Xxxx xxxxxxxx xxxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx xx xxxxxxxxx x&xxxx;Xxxxxxx xxxxxxxx Xxxxxxxx xxxx.
Xxxx nařízení xx xxxxxxx x&xxxx;xxxxx rozsahu x&xxxx;xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx xxxxxxx.
X&xxxx;Xxxxxxx xxx 12.&xxxx;xxxxx 2024.
Xx Xxxxxx
xxxxxxxxxxx
Xxxxxx XXX DER XXXXX
(1)&xxxx;&xxxx; Xx.&xxxx;xxxx.&xxxx;X&xxxx;268, 18.10.2003, x.&xxxx;29.
(2)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Komise (XX) č. 403/2013 xx xxx 2.&xxxx;xxxxxx&xxxx;2013 x&xxxx;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 xxxxxxxxx látky xxx xxxxx drůbeže, xxxxxxx x&xxxx;xxx odstavená xxxxxx x&xxxx;xxxxxx xx xxxx xxxxxxxx (ES) č. 1259/2004, (XX) x.&xxxx;1206/2005 a (ES) x.&xxxx;1876/2006 (xxxxxxx povolení XXX Xxxxxxxxxxx Xxxxxxxx) (Xx.&xxxx;xxxx.&xxxx;X&xxxx;121, 3.5.2013, x.&xxxx;26).
(3)&xxxx;&xxxx; XXXX Xxxxxxx 2023;21(6):8043.
XXXXXXX
Xxxxxxxxxxxxx xxxxx xxxxxxxxx xxxxx |
Xxxxx xxxxxxxx xxxxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, xxxxxxxx vzorec, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx kategorie xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxx xxxxxxxxxx |
Xxxxx xxxxxxxxx povolení |
||||||||||||||||||||||
Jednotky xxxxxxxx/xx xxxxxxxxxxx krmiva x&xxxx;xxxxxx xxxxxxxx 12&xxxx;% |
|||||||||||||||||||||||||||||||
Xxxxxxxxx: xxxxxxxxxxxx xxxxxxxxx xxxxx. Xxxxxxx xxxxxxx: xxxxx xxxxxxxxx xxxxxxxxxxxxx. |
|||||||||||||||||||||||||||||||
4x1602x |
XXX Xxxxxxxxxxx Xxxxxxxx |
Xxxx–1,4-xxxx-xxxxxxxx (XX 3.2.1.8) Xxxx–1,3(4)-xxxx-xxxxxxxxx (XX 3.2.1.6) Endo–1,4-beta-glukanáza (ES 3.2.1.4) |
Xxxxxxx doplňkové xxxxx Xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, xxxx–1,3(4)-xxxx-xxxxxxxxx a endo–1,4-beta-glukanázy x&xxxx;Xxxxxxxxxxx xxxxxx ATCC 74444 x&xxxx;xxxxxxx xxxxxxxx xxx:
Xxxxxxx nebo xxxxx xxxxx. Xxxxxxxxxxxxxxx xxxxxx 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 (ES 3.2.1.4) x&xxxx;Xxxxxxxxxxx xxxxxx XXXX 74444 Xxxxxxxxxx xxxxxx&xxxx; (4)
|
Xxxxx xxxxx xxxxx xxxxxxx kromě xxxxxx xxxx |
— |
Xxxx–1,4-xxxx-xxxxxxxx: 135 U Endo–1,3(4)-beta-glukanáza: 35 X Xxxx–1,4-xxxx-xxxxxxxxx: 40 X |
— |
|
4.&xxxx;xxxxx 2034 |
||||||||||||||||||||||
Všechny xxxxx xxxxxxx xxxxxx xx xxxxxx |
Xxxx–1,4-xxxx-xxxxxxxx: 216 U Endo–1,3(4)-beta-glukanáza: 56 U Endo–1,4-beta-glukanáza: 64 X |
||||||||||||||||||||||||||||||
Xxxxx xxxx Xxxxxx (xxxxxxxxx) |
Xxxx–1,4-xxxx-xxxxxxxx: 270 U Endo–1,3(4)-beta-glukanáza: 70 X Xxxx–1,4-xxxx-xxxxxxxxx: 80 X |
(1)&xxxx;&xxxx;Xxxxx xxxxxxxx (U) xxxx-1,4-xxxx-xxxxxxxx xx množství xxxxxx, xxxxx xxxxxx 1 xxxxxxxxx xxxxxxxxxxxx cukru (xxxxxxxxxx xxxxxx) za xxxxxx x&xxxx;xxxxxxxxxx arabinoxylanu xxx xxxxxxx 40 °C a pH 5,0.
(2) Jedna xxxxxxxx (U) endo-1,3(4)-beta-glukanázy xx xxxxxxxx enzymu, xxxxx uvolní 1 xxxxxxxxx xxxxxxxxxxxx xxxxx (xxxxxxxxxx xxxxxxx) za xxxxxx x&xxxx;xxxxxxx xxxx-xxxxxxx xxx teplotě 40&xxxx;°X&xxxx;x&xxxx;xX&xxxx;5,0.
(3)&xxxx;&xxxx;Xxxxx xxxxxxxx (U) xxxx-1,4-xxxx-xxxxxxxxx xx xxxxxxxx xxxxxx, xxxxx xxxxxx 1 xxxxxxxxx redukujícího xxxxx (xxxxxxxxxx xxxxxxx) za xxxxxx x&xxxx;xxxxxxxxxxxxxxxxxxxxx xxx xxxxxxx 40&xxxx;°X&xxxx;x&xxxx;xX&xxxx;5,0.
(4)&xxxx;&xxxx;Xxxxxxxx informace x&xxxx;xxxxxxxxxxxx metodách xxx xxxxxx xx xxxxxxxxxxx xxxxxxx referenční xxxxxxxxxx: xxxxx://xxxxx-xxxxxxxx-xxxxxx.xx.xxxxxx.xx/xxxx-xx-xxxx-xxxx-xxxxxxxxx/xxxx-xx-xxxxxxxxxxxxx/xxxx-xx-xxxxxxxxxx-xxxxxxx_xx.