XXXXXXXXX XXXXXXXX KOMISE (XX) 2024/221
ze xxx 12.&xxxx;xxxxx 2024
x&xxxx;xxxxxxxx xxxxxxxx xxxxxxxxx z endo–1,4-beta-xylanázy, endo–1,3(4)-beta-glukanázy x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx z Trichoderma xxxxxx XXXX 74444&xxxx;xxxx xxxxxxxxx xxxxx xxx xxxxx xxxxx druhů drůbeže, xxxxxxx xxxxx xxxxxxx xxxxxx xx xxxxxx x&xxxx;xxxxxxxxx xxxxxx (držitel xxxxxxxx: XXX Nutritional Xxxxxxxx) x&xxxx;x&xxxx;xxxxx xxxxxxxxxxx xxxxxxxx (EU) x.&xxxx;403/2013
(Xxxx x&xxxx;xxxxxxxx pro EHP)
EVROPSKÁ XXXXXX,
x&xxxx;xxxxxxx na Xxxxxxx x&xxxx;xxxxxxxxx Xxxxxxxx unie,
s ohledem xx xxxxxxxx Evropského xxxxxxxxxx a Rady (ES) x.&xxxx;1831/2003 xx xxx 22.&xxxx;xxxx&xxxx;2003 o doplňkových xxxxxxx xxxxxxxxxxx xx výživě xxxxxx&xxxx;(1), a zejména na xx.&xxxx;9 xxxx.&xxxx;2 uvedeného xxxxxxxx,
xxxxxxxx x&xxxx;xxxxx xxxxxxx:
(1) |
Xxxxxxxx (XX) č. 1831/2003 xxxxxxx xxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxx xx výživě xxxxxx x&xxxx;xxxxxx x&xxxx;xxxxxxx, xx xxxxxxx základě xx xxxxxxxx xxxxxxx x&xxxx;xxxxxxxx. |
(2) |
Xxxxxxxxx z endo–1,4-beta-xylanázy, endo–1,3(4)-beta-glukanázy 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). |
(3) |
X&xxxx;xxxxxxx x&xxxx;xx.&xxxx;14 xxxx.&xxxx;1 xxxxxxxx (ES) x.&xxxx;1831/2003 xxxx podána xxxxxx x&xxxx;xxxxxxxx xxxxxxxx přípravku 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&xxxx;xxxx xxxxxxxxx látky. Xxxxxxx žádost byla xxxxxx xxxxx x&xxxx;xxxxx x&xxxx;xxxxxxxxx xxxxxxxxxxxx xxxxx xx.&xxxx;14 xxxx.&xxxx;2 xxxxxxxx (XX) x.&xxxx;1831/2003. |
(4) |
Xxxxxxxx úřad xxx xxxxxxxxxx potravin (xxxx jen „xxxx“) xxxxxx ve xxxx xxxxxxxxxx xx dne 11.&xxxx;xxxxxx&xxxx;2023&xxxx;(3) 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 reesei XXXX 74444 je xx xxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxx x&xxxx;xxxxxx xxxxxxxx xxx výkrm xxxxxxx, xxxxxxx x&xxxx;xxx xxxxxxxxx xxxxxx, xxxxxxxxxxxx x&xxxx;xxxxxxx prostředí. Xxxx xxxxxx xxxxxx k závěru, 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 XXXX 74444 xx xxx xxx xxxxxxxxx xx xxxxx xxxxxxxxxxx senzibilizující xxxxxxx xxxxx. Xxxxxxxx k tomu, xx nejsou k dispozici xxxxx, nebyl úřad xxxxxxx vyvodit xxxxx xxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxx xxxx x&xxxx;xxx xxxx xxxxxxxxxxxxx kůže. Xxxx xxxxxx uvedl, xx x&xxxx;xxxxxxxxxxx x&xxxx;xxxxxxxxx povolení xxxx xxxxx xxxxxxxxx xxxxxxxx přípravku z endo–1,4-beta-xylanázy, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx z Trichoderma xxxxxx ATCC 74444. Xxxx xxxxxxxxxxx xxxxxxxx xxxxxxxxx na monitorování xx uvedení xx xxx xx xxxxx. Xxxx xxxx xxxxxx xxxxxx o metodách xxxxxxx xxxxxxxxx xxxxx xxxxxxx xx krmiv xxxxxxxxxxx xxxxxxxxxx xxxxxxxxxx, xxxxxxxx xxxxxxxxx (XX) x.&xxxx;1831/2003. |
(5) |
Xxxxxxxx x&xxxx;xxxx uvedeným skutečnostem xx Xxxxxx domnívá, xx přípravek 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 (ES) x.&xxxx;1831/2003. Xxxxx by xxxxxxxx xxxxxxx xxxxxxxxx xxxxx mělo xxx xxxxxxxx. Vedle xxxx xx Xxxxxx xxxxxxx, xx xx xxxx xxx xxxxxxx xxxxxx xxxxxxxx xxxxxxxx, aby xx zabránilo xxxxxxxxxxx xxxxxxx xx zdraví xxxxxxxxx xxxx xxxxxxxxx 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 z Trichoderma xxxxxx XXXX 74444&xxxx;xxxx xxxxxxxxx xxxxx by xxxx xxx xxxxxxx prováděcí xxxxxxxx (XX) x.&xxxx;403/2013. |
(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 ATCC 74444, xx xxxxxx xxxxxxxx xxxxxxxxx xxxxxx, xxxxx xx zúčastněným xxxxxxx umožnilo připravit xx na xxxxxx xxxxxx xxxxxxxxx xxxxxxxxxxxxx x&xxxx;xxxxxxxx povolení. |
(8) |
Opatření xxxxxxxxx xxxxx nařízením xxxx x&xxxx;xxxxxxx xx xxxxxxxxxxx Xxxxxxx xxxxxx xxx xxxxxxxx, xxxxxxx, potraviny x&xxxx;xxxxxx, |
XXXXXXX XXXX XXXXXXXX:
Xxxxxx&xxxx;1
Xxxxxxxx povolení
Povolení xxxxxxxxx xxxxxxxxx x&xxxx;xxxxxxx, xxxxxxxxxxxx xx xxxxxxxxx xxxxxxxxxxx xxxxx „xxxxxxxxxxxx xxxxxxxxx xxxxx“ x&xxxx;xxxxxxx xxxxxxx „xxxxx xxxxxxxxx xxxxxxxxxxxxx“, xx obnovuje xxxxx xxxxxxxx xxxxxxxxxxx v uvedené xxxxxxx.
Článek 2
Změna prováděcího xxxxxxxx (XX) x.&xxxx;403/2013
Xxxxxxxxx nařízení (XX) č. 403/2013 xx xxxx xxxxx:
1. |
xxxxxx&xxxx;1 xx xxxxxxx; |
2. |
xxxxxxx se zrušuje. |
Xxxxxx&xxxx;3
Xxxxxxxxx xxxxxxxx
1.&xxxx;&xxxx;&xxxx;Xxxxxxxxx xxxxxxx x&xxxx;xxxxxxx x&xxxx;xxxxxxx obsahující xxxxx xxxxxxxxx, xxxxxxxx x&xxxx;xxxxxxxx xxxx dnem 4.&xxxx;xxxxx 2024 x&xxxx;xxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx xxxx 4. února 2024, xxxxx xxx xxxxxx xxxxxxx na xxx x&xxxx;xxxxxxxxx až xx xxxxxxxxx xxxxxxxxxxx xxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxx xxxxx x&xxxx;xxxxx suroviny xxxxxxxxxx přípravek uvedený x&xxxx;xxxxxxx, xxxxxxxx x&xxxx;xxxxxxxx xxxx 4. xxxxxx 2025 x&xxxx;xxxxxxx s pravidly xxxxxxxx xxxx 4. xxxxxx 2024, mohou xxx xxxxxxx xx xxx x&xxxx;xxxxxxxxx xx xx vyčerpání xxxxxxxxxxx xxxxx.
Xxxxxx&xxxx;4
Xxxxx v platnost
Toto nařízení xxxxxxxx x&xxxx;xxxxxxxx dvacátým xxxx xx vyhlášení x&xxxx;Xxxxxxx xxxxxxxx Xxxxxxxx xxxx.
Xxxx xxxxxxxx xx xxxxxxx x&xxxx;xxxxx xxxxxxx x&xxxx;xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx státech.
V Bruselu xxx 12.&xxxx;xxxxx 2024.
Xx Xxxxxx
xxxxxxxxxxx
Xxxxxx XXX XXX XXXXX
(1)&xxxx;&xxxx; Úř. věst. L 268, 18.10.2003, x.&xxxx;29.
(2)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Komise (XX) x.&xxxx;403/2013 ze xxx 2. května 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) xxxx xxxxxxxxx látky xxx xxxxx xxxxxxx, xxxxxxx x&xxxx;xxx xxxxxxxxx xxxxxx x&xxxx;xxxxxx se mění xxxxxxxx (XX) x.&xxxx;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.
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Xxxxxxxxxxxxx číslo xxxxxxxxx xxxxx |
Xxxxx xxxxxxxx xxxxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, xxxxxxxx xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx kategorie zvířat |
Maximální xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxx xxxxxxxxxx |
Xxxxx xxxxxxxxx xxxxxxxx |
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Xxxxxxxx xxxxxxxx/xx kompletního krmiva x&xxxx;xxxxxx vlhkosti 12&xxxx;% |
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Xxxxxxxxx: xxxxxxxxxxxx xxxxxxxxx xxxxx. Xxxxxxx skupina: xxxxx xxxxxxxxx xxxxxxxxxxxxx. |
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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 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 xxxxxx XXXX 74444 x&xxxx;xxxxxxx aktivity 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 (XX 3.2.1.4) x&xxxx;Xxxxxxxxxxx xxxxxx XXXX 74444 Xxxxxxxxxx xxxxxx&xxxx; (4)
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Xxxxx xxxxx xxxxx xxxxxxx xxxxx xxxxxx xxxx |
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Xxxx–1,4-xxxx-xxxxxxxx: 135 X Xxxx–1,3(4)-xxxx-xxxxxxxxx: 35 X Xxxx–1,4-xxxx-xxxxxxxxx: 40 X |
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4.&xxxx;xxxxx 2034 |
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Všechny xxxxx xxxxxxx xxxxxx xx xxxxxx |
Xxxx–1,4-xxxx-xxxxxxxx: 216 X Xxxx–1,3(4)-xxxx-xxxxxxxxx: 56 X Xxxx–1,4-xxxx-xxxxxxxxx: 64 X |
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Xxxxx xxxx Xxxxxx (xxxxxxxxx) |
Xxxx–1,4-xxxx-xxxxxxxx: 270 X Xxxx–1,3(4)-xxxx-xxxxxxxxx: 70 X Xxxx–1,4-xxxx-xxxxxxxxx: 80 U |
(1) Jedna xxxxxxxx (X) endo-1,4-beta-xylanázy xx množství enzymu, xxxxx xxxxxx 1 xxxxxxxxx redukujícího cukru (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) xxxx-1,3(4)-xxxx-xxxxxxxxx xx xxxxxxxx enzymu, xxxxx uvolní 1 xxxxxxxxx xxxxxxxxxxxx cukru (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 (X) xxxx-1,4-xxxx-xxxxxxxxx xx xxxxxxxx xxxxxx, xxxxx xxxxxx 1 xxxxxxxxx xxxxxxxxxxxx xxxxx (xxxxxxxxxx glukózy) xx xxxxxx x&xxxx;xxxxxxxxxxxxxxxxxxxxx xxx xxxxxxx 40&xxxx;°X&xxxx;x&xxxx;xX&xxxx;5,0.
(4)&xxxx;&xxxx;Xxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxxxxx metodách xxx xxxxxx xx xxxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxxxxxxx: xxxxx://xxxxx-xxxxxxxx-xxxxxx.xx.xxxxxx.xx/xxxx-xx-xxxx-xxxx-xxxxxxxxx/xxxx-xx-xxxxxxxxxxxxx/xxxx-xx-xxxxxxxxxx-xxxxxxx_xx.