PROVÁDĚCÍ XXXXXXXX KOMISE (XX) 2024/221
xx xxx 12.&xxxx;xxxxx 2024
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 doplňkové xxxxx pro xxxxx xxxxx xxxxx xxxxxxx, xxxxxxx xxxxx xxxxxxx xxxxxx ke snášce x&xxxx;xxxxxxxxx selata (xxxxxxx xxxxxxxx: XXX Nutritional Xxxxxxxx) x&xxxx;x&xxxx;xxxxx xxxxxxxxxxx xxxxxxxx (XX) x.&xxxx;403/2013
(Xxxx x&xxxx;xxxxxxxx pro XXX)
XXXXXXXX XXXXXX,
x&xxxx;xxxxxxx xx Xxxxxxx x&xxxx;xxxxxxxxx Evropské xxxx,
x&xxxx;xxxxxxx xx xxxxxxxx Evropského xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;1831/2003 xx dne 22.&xxxx;xxxx&xxxx;2003 x&xxxx;xxxxxxxxxxx látkách xxxxxxxxxxx xx xxxxxx xxxxxx&xxxx;(1), x&xxxx;xxxxxxx na xx.&xxxx;9 odst. 2 xxxxxxxxx xxxxxxxx,
xxxxxxxx x&xxxx;xxxxx důvodům:
(1) |
Nařízení (XX) x.&xxxx;1831/2003 xxxxxxx xxxxxxxx xxxxxxxxxxx látek xxxxxxxxxxx xx xxxxxx xxxxxx a důvody x&xxxx;xxxxxxx, xx xxxxxxx xxxxxxx xx xxxxxxxx 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 reesei XXXX 74444 xxx xxxxxxx xx xxxxx xxx jako doplňková xxxxx pro xxxxx xxxxxxx, xxxxxxx x&xxxx;xxx xxxxxxxxx selata xxxxxxxxxx xxxxxxxxx Xxxxxx (EU) x.&xxxx;403/2013&xxxx;(2). |
(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 a endo–1,4-beta-glukanázy x&xxxx;Xxxxxxxxxxx reesei XXXX 74444&xxxx;xxxx xxxxxxxxx xxxxx. Xxxxxxx xxxxxx byla xxxxxx xxxxx s údaji x&xxxx;xxxxxxxxx požadovanými xxxxx xx.&xxxx;14 xxxx.&xxxx;2 xxxxxxxx (XX) č. 1831/2003. |
(4) |
Evropský úřad xxx xxxxxxxxxx potravin (xxxx xxx „xxxx“) xxxxxx xx xxxx xxxxxxxxxx xx xxx 11.&xxxx;xxxxxx&xxxx;2023&xxxx;(3) k závěru, že xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, endo–1,3(4)-beta-glukanázy x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx z Trichoderma xxxxxx XXXX 74444 xx xx xxxxxxxxxxx xxxxxxxxxx xxxxxxxx použití x&xxxx;xxxxxx xxxxxxxx pro xxxxx xxxxxxx, xxxxxxx a pro xxxxxxxxx selata, xxxxxxxxxxxx x&xxxx;xxxxxxx prostředí. Xxxx xxxxxx xxxxxx 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 xxx xxx xxxxxxxxx xx xxxxx xxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxx xxxxx. Vzhledem x&xxxx;xxxx, xx nejsou x&xxxx;xxxxxxxxx xxxxx, xxxxx xxxx xxxxxxx vyvodit závěr xxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxxxx podráždění xxxx x&xxxx;xxx xxxx xxxxxxxxxxxxx kůže. Úřad xxxxxx xxxxx, že x&xxxx;xxxxxxxxxxx x&xxxx;xxxxxxxxx xxxxxxxx xxxx xxxxx xxxxxxxxx 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. Xxxx xxxxxxxxxxx xxxxxxxx xxxxxxxxx xx xxxxxxxxxxxx xx uvedení xx xxx xx xxxxx. Xxxx také xxxxxx xxxxxx x&xxxx;xxxxxxxx xxxxxxx xxxxxxxxx xxxxx přidané xx krmiv xxxxxxxxxxx xxxxxxxxxx xxxxxxxxxx, xxxxxxxx xxxxxxxxx (XX) 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 x&xxxx;Xxxxxxxxxxx xxxxxx XXXX 74444 xxxxxxx xxxxxxxx xxxxxxxxx x&xxxx;xxxxxx&xxxx;5 xxxxxxxx (XX) x.&xxxx;1831/2003. Xxxxx xx xxxxxxxx xxxxxxx doplňkové xxxxx xxxx xxx xxxxxxxx. Xxxxx toho xx Xxxxxx xxxxxxx, xx by xxxx xxx přijata vhodná xxxxxxxx xxxxxxxx, xxx xx zabránilo xxxxxxxxxxx xxxxxxx xx xxxxxx xxxxxxxxx dané xxxxxxxxx xxxxx. |
(6) |
X&xxxx;xxxxxxxx obnovení 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 xx mělo xxx xxxxxxx xxxxxxxxx xxxxxxxx (EU) x.&xxxx;403/2013. |
(7) |
Xxxxxxxx x&xxxx;xxxx, xx bezpečnostní xxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxx změn x&xxxx;xxxxxxxxxx xxx 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, xx xxxxxx xxxxxxxx xxxxxxxxx období, xxxxx xx xxxxxxxxxxx xxxxxxx umožnilo xxxxxxxxx xx na plnění xxxxxx xxxxxxxxx xxxxxxxxxxxxx x&xxxx;xxxxxxxx povolení. |
(8) |
Opatření xxxxxxxxx xxxxx xxxxxxxxx jsou x&xxxx;xxxxxxx xx xxxxxxxxxxx Xxxxxxx xxxxxx xxx xxxxxxxx, xxxxxxx, potraviny x&xxxx;xxxxxx, |
XXXXXXX TOTO XXXXXXXX:
Článek 1
Obnovení xxxxxxxx
Xxxxxxxx přípravku xxxxxxxxx x&xxxx;xxxxxxx, xxxxxxxxxxxx xx xxxxxxxxx xxxxxxxxxxx xxxxx „xxxxxxxxxxxx doplňkové xxxxx“ x&xxxx;xxxxxxx skupiny „xxxxx xxxxxxxxx stravitelnost“, xx obnovuje xxxxx xxxxxxxx stanovených x&xxxx;xxxxxxx xxxxxxx.
Článek 2
Změna xxxxxxxxxxx xxxxxxxx (XX) x.&xxxx;403/2013
Xxxxxxxxx xxxxxxxx (XX) x.&xxxx;403/2013 xx xxxx xxxxx:
1. |
xxxxxx&xxxx;1 se xxxxxxx; |
2. |
xxxxxxx xx xxxxxxx. |
Článek 3
Přechodná xxxxxxxx
1.&xxxx;&xxxx;&xxxx;Xxxxxxxxx xxxxxxx x&xxxx;xxxxxxx a premixy obsahující xxxxx přípravek, xxxxxxxx x&xxxx;xxxxxxxx xxxx xxxx 4.&xxxx;xxxxx 2024 x&xxxx;xxxxxxx x&xxxx;xxxxxxxx xxxxxxxx před xxxx 4.&xxxx;xxxxx 2024, xxxxx být xxxxxx xxxxxxx xx xxx x&xxxx;xxxxxxxxx až xx xxxxxxxxx stávajících xxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxx xxxxx x&xxxx;xxxxx suroviny xxxxxxxxxx xxxxxxxxx xxxxxxx x&xxxx;xxxxxxx, xxxxxxxx x&xxxx;xxxxxxxx xxxx 4. xxxxxx 2025 x&xxxx;xxxxxxx s pravidly xxxxxxxx xxxx 4. xxxxxx 2024, xxxxx xxx xxxxxxx xx xxx x&xxxx;xxxxxxxxx xx xx xxxxxxxxx xxxxxxxxxxx xxxxx.
Článek 4
Vstup x&xxxx;xxxxxxxx
Xxxx nařízení xxxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx xx xxxxxxxxx x&xxxx;Xxxxxxx xxxxxxxx Xxxxxxxx xxxx.
Xxxx nařízení je xxxxxxx x&xxxx;xxxxx xxxxxxx x&xxxx;xxxxx použitelné 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 nařízení Xxxxxx (XX) x.&xxxx;403/2013 ze xxx 2. května 2013 o povolení xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, endo–1,3(4)-beta-glukanázy x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxx (XXXX 74444) xxxx xxxxxxxxx xxxxx xxx xxxxx xxxxxxx, xxxxxxx x&xxxx;xxx xxxxxxxxx selata x&xxxx;xxxxxx xx xxxx xxxxxxxx (XX) x.&xxxx;1259/2004, (XX) x.&xxxx;1206/2005 x&xxxx;(XX) x.&xxxx;1876/2006 (xxxxxxx xxxxxxxx XXX Xxxxxxxxxxx Products) (Xx.&xxxx;xxxx.&xxxx;X&xxxx;121, 3.5.2013, s. 26).
(3) XXXX Xxxxxxx 2023;21(6):8043.
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Xxxxxxxxxxxxx xxxxx doplňkové xxxxx |
Xxxxx xxxxxxxx xxxxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, xxxxxxxx xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx xxxxxxxxx xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxx xxxxxxxxxx |
Xxxxx xxxxxxxxx xxxxxxxx |
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Xxxxxxxx xxxxxxxx/xx kompletního krmiva x&xxxx;xxxxxx xxxxxxxx 12&xxxx;% |
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Xxxxxxxxx: xxxxxxxxxxxx doplňkové látky. Xxxxxxx xxxxxxx: látky xxxxxxxxx stravitelnost. |
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4a1602i |
DSM Xxxxxxxxxxx Xxxxxxxx |
Xxxx–1,4-xxxx-xxxxxxxx (XX 3.2.1.8) Endo–1,3(4)-beta-glukanáza (ES 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 a endo–1,4-beta-glukanázy x&xxxx;Xxxxxxxxxxx reesei XXXX 74444 x&xxxx;xxxxxxx xxxxxxxx xxx:
Kapalná xxxx 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 ATCC 74444 Xxxxxxxxxx metoda (4)
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Xxxxx xxxxx xxxxx xxxxxxx kromě xxxxxx xxxx |
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Xxxx–1,4-xxxx-xxxxxxxx: 135 X Xxxx–1,3(4)-xxxx-xxxxxxxxx: 35 U Endo–1,4-beta-glukanáza: 40 X |
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4.&xxxx;xxxxx 2034 |
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Xxxxxxx xxxxx xxxxxxx xxxxxx ke xxxxxx |
Xxxx–1,4-xxxx-xxxxxxxx: 216 U Endo–1,3(4)-beta-glukanáza: 56 X Xxxx–1,4-xxxx-xxxxxxxxx: 64 X |
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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 (X) xxxx-1,4-xxxx-xxxxxxxx xx xxxxxxxx xxxxxx, xxxxx xxxxxx 1 xxxxxxxxx xxxxxxxxxxxx xxxxx (xxxxxxxxxx xxxxxx) za xxxxxx x&xxxx;xxxxxxxxxx xxxxxxxxxxxxx xxx teplotě 40&xxxx;°X&xxxx;x&xxxx;xX&xxxx;5,0.
(2)&xxxx;&xxxx;Xxxxx xxxxxxxx (X) endo-1,3(4)-beta-glukanázy xx množství enzymu, xxxxx xxxxxx 1 xxxxxxxxx redukujícího xxxxx (xxxxxxxxxx xxxxxxx) za xxxxxx x&xxxx;xxxxxxx beta-glukanu xxx xxxxxxx 40&xxxx;°X&xxxx;x&xxxx;xX&xxxx;5,0.
(3)&xxxx;&xxxx;Xxxxx xxxxxxxx (U) xxxx-1,4-xxxx-xxxxxxxxx xx množství xxxxxx, xxxxx xxxxxx 1 xxxxxxxxx xxxxxxxxxxxx xxxxx (xxxxxxxxxx xxxxxxx) xx xxxxxx z karboxymethylcelulosy xxx xxxxxxx 40 °C a pH 5,0.
(4) Podrobné xxxxxxxxx x&xxxx;xxxxxxxxxxxx metodách xxx xxxxxx xx internetové xxxxxxx referenční laboratoře: xxxxx://xxxxx-xxxxxxxx-xxxxxx.xx.xxxxxx.xx/xxxx-xx-xxxx-xxxx-xxxxxxxxx/xxxx-xx-xxxxxxxxxxxxx/xxxx-xx-xxxxxxxxxx-xxxxxxx_xx.