XXXXXXXXX XXXXXXXX XXXXXX (XX) 2024/221
ze xxx 12.&xxxx;xxxxx 2024
o obnovení povolení 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&xxxx;xxxx doplňkové xxxxx pro xxxxx xxxxx xxxxx xxxxxxx, xxxxxxx xxxxx xxxxxxx xxxxxx xx xxxxxx x&xxxx;xxxxxxxxx xxxxxx (držitel xxxxxxxx: DSM Nutritional Xxxxxxxx) x&xxxx;x&xxxx;xxxxx xxxxxxxxxxx xxxxxxxx (EU) č. 403/2013
(Text x&xxxx;xxxxxxxx xxx XXX)
XXXXXXXX XXXXXX,
x&xxxx;xxxxxxx xx Xxxxxxx x&xxxx;xxxxxxxxx Xxxxxxxx unie,
s ohledem xx nařízení Xxxxxxxxxx xxxxxxxxxx a Rady (ES) x.&xxxx;1831/2003 ze xxx 22.&xxxx;xxxx&xxxx;2003 x&xxxx;xxxxxxxxxxx xxxxxxx xxxxxxxxxxx xx xxxxxx xxxxxx&xxxx;(1), x&xxxx;xxxxxxx xx xx.&xxxx;9 xxxx.&xxxx;2 xxxxxxxxx xxxxxxxx,
xxxxxxxx k těmto xxxxxxx:
|
(1) |
Xxxxxxxx (XX) x.&xxxx;1831/2003 xxxxxxx xxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxx xx xxxxxx xxxxxx x&xxxx;xxxxxx 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 xxxxxx XXXX 74444 byl xxxxxxx xx deset xxx xxxx doplňková xxxxx xxx xxxxx xxxxxxx, xxxxxxx a pro xxxxxxxxx xxxxxx prováděcím xxxxxxxxx Xxxxxx (EU) x.&xxxx;403/2013&xxxx;(2). |
|
(3) |
X&xxxx;xxxxxxx s čl. 14 xxxx.&xxxx;1 xxxxxxxx (XX) x.&xxxx;1831/2003 xxxx podána xxxxxx x&xxxx;xxxxxxxx povolení 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;xxxx xxxxxxxxx xxxxx. Xxxxxxx xxxxxx xxxx xxxxxx spolu s údaji x&xxxx;xxxxxxxxx xxxxxxxxxxxx podle xx.&xxxx;14 xxxx.&xxxx;2 xxxxxxxx (XX) x.&xxxx;1831/2003. |
|
(4) |
Xxxxxxxx úřad xxx xxxxxxxxxx xxxxxxxx (xxxx xxx „xxxx“) xxxxxx xx xxxx 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 je xx xxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxx x&xxxx;xxxxxx xxxxxxxx xxx xxxxx xxxxxxx, xxxxxxx a pro xxxxxxxxx selata, xxxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxxxx. Úřad xxxxxx xxxxxx k závěru, 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 xx xxx xxx xxxxxxxxx xx látku xxxxxxxxxxx senzibilizující xxxxxxx xxxxx. Vzhledem k tomu, xx xxxxxx x&xxxx;xxxxxxxxx xxxxx, xxxxx úřad xxxxxxx xxxxxxx xxxxx xxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxx způsobit xxxxxxxxxx xxxx x&xxxx;xxx xxxx xxxxxxxxxxxxx xxxx. Xxxx xxxxxx xxxxx, xx x&xxxx;xxxxxxxxxxx s obnovením 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 xxxxxxxxxxx xxxxxxxx xxxxxxxxx xx monitorování xx xxxxxxx xx xxx xx xxxxx. Xxxx xxxx ověřil xxxxxx o metodách xxxxxxx xxxxxxxxx xxxxx přidané xx xxxxx xxxxxxxxxxx xxxxxxxxxx xxxxxxxxxx, xxxxxxxx xxxxxxxxx (XX) x.&xxxx;1831/2003. |
|
(5) |
Xxxxxxxx x&xxxx;xxxx xxxxxxxx xxxxxxxxxxxx xx Xxxxxx domnívá, xx přípravek 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 xxxxxxx xxxxxxxx xxxxxxxxx x&xxxx;xxxxxx&xxxx;5 xxxxxxxx (XX) x.&xxxx;1831/2003. Xxxxx by xxxxxxxx xxxxxxx xxxxxxxxx xxxxx mělo xxx xxxxxxxx. Xxxxx toho xx Xxxxxx xxxxxxx, xx by měla xxx přijata vhodná xxxxxxxx xxxxxxxx, xxx xx zabránilo xxxxxxxxxxx xxxxxxx na xxxxxx xxxxxxxxx dané xxxxxxxxx xxxxx. |
|
(6) |
X&xxxx;xxxxxxxx xxxxxxxx povolení xxxxxxxxx z endo–1,4-beta-xylanázy, endo–1,3(4)-beta-glukanázy x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxx XXXX 74444 jako xxxxxxxxx xxxxx xx xxxx xxx změněno prováděcí xxxxxxxx (XX) x.&xxxx;403/2013. |
|
(7) |
Xxxxxxxx x&xxxx;xxxx, xx xxxxxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxx změn x&xxxx;xxxxxxxxxx xxx xxxxxxxx přípravku x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, endo–1,3(4)-beta-glukanázy x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx reesei ATCC 74444, je xxxxxx xxxxxxxx přechodné období, xxxxx xx xxxxxxxxxxx xxxxxxx xxxxxxxx xxxxxxxxx xx xx xxxxxx xxxxxx xxxxxxxxx xxxxxxxxxxxxx x&xxxx;xxxxxxxx povolení. |
|
(8) |
Opatření xxxxxxxxx xxxxx nařízením xxxx x&xxxx;xxxxxxx xx xxxxxxxxxxx Xxxxxxx xxxxxx xxx xxxxxxxx, zvířata, xxxxxxxxx x&xxxx;xxxxxx, |
XXXXXXX XXXX NAŘÍZENÍ:
Xxxxxx&xxxx;1
Xxxxxxxx xxxxxxxx
Xxxxxxxx xxxxxxxxx xxxxxxxxx x&xxxx;xxxxxxx, xxxxxxxxxxxx xx xxxxxxxxx doplňkových xxxxx „xxxxxxxxxxxx xxxxxxxxx xxxxx“ x&xxxx;xxxxxxx xxxxxxx „xxxxx xxxxxxxxx stravitelnost“, xx xxxxxxxx xxxxx xxxxxxxx xxxxxxxxxxx v uvedené xxxxxxx.
Xxxxxx&xxxx;2
Xxxxx xxxxxxxxxxx xxxxxxxx (XX) x.&xxxx;403/2013
Xxxxxxxxx nařízení (XX) x.&xxxx;403/2013 xx xxxx xxxxx:
|
1. |
xxxxxx&xxxx;1 se xxxxxxx; |
|
2. |
xxxxxxx se zrušuje. |
Článek 3
Přechodná opatření
1. Přípravek uvedený x&xxxx;xxxxxxx x&xxxx;xxxxxxx xxxxxxxxxx xxxxx xxxxxxxxx, vyrobené x&xxxx;xxxxxxxx xxxx xxxx 4.&xxxx;xxxxx 2024 v souladu x&xxxx;xxxxxxxx xxxxxxxx xxxx xxxx 4.&xxxx;xxxxx 2024, xxxxx xxx xxxxxx xxxxxxx na xxx x&xxxx;xxxxxxxxx až xx xxxxxxxxx xxxxxxxxxxx xxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxx xxxxx a krmné xxxxxxxx xxxxxxxxxx xxxxxxxxx uvedený x&xxxx;xxxxxxx, vyrobené x&xxxx;xxxxxxxx xxxx 4. únorem 2025 x&xxxx;xxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx 4. xxxxxx 2024, mohou xxx xxxxxxx na xxx x&xxxx;xxxxxxxxx až xx xxxxxxxxx xxxxxxxxxxx xxxxx.
Xxxxxx&xxxx;4
Xxxxx x&xxxx;xxxxxxxx
Xxxx nařízení xxxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx po vyhlášení x&xxxx;Xxxxxxx věstníku Xxxxxxxx xxxx.
Xxxx nařízení je xxxxxxx v celém rozsahu x&xxxx;xxxxx použitelné ve xxxxx xxxxxxxxx xxxxxxx.
X&xxxx;Xxxxxxx xxx 12.&xxxx;xxxxx 2024.
Xx Xxxxxx
xxxxxxxxxxx
Xxxxxx VON DER XXXXX
(1)&xxxx;&xxxx; Úř. věst. L 268, 18.10.2003, x.&xxxx;29.
(2)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Xxxxxx (XX) x.&xxxx;403/2013 ze xxx 2. května 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) jako xxxxxxxxx látky xxx xxxxx xxxxxxx, nosnice x&xxxx;xxx odstavená selata x&xxxx;xxxxxx xx xxxx xxxxxxxx (ES) x.&xxxx;1259/2004, (XX) č. 1206/2005 a (ES) 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.
PŘÍLOHA
|
Identifikační xxxxx doplňkové xxxxx |
Xxxxx držitele xxxxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, xxxxxxxx vzorec, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx xxxxxxxxx zvířat |
Maximální xxxxx |
Xxxxxxxxx obsah |
Maximální xxxxx |
Xxxx xxxxxxxxxx |
Xxxxx xxxxxxxxx xxxxxxxx |
||||||||||||||||||||||
|
Xxxxxxxx xxxxxxxx/xx xxxxxxxxxxx xxxxxx x&xxxx;xxxxxx xxxxxxxx 12 % |
|||||||||||||||||||||||||||||||
|
Kategorie: xxxxxxxxxxxx xxxxxxxxx xxxxx. Xxxxxxx skupina: 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) Xxxx–1,4-xxxx-xxxxxxxxx (XX 3.2.1.4) |
Xxxxxxx xxxxxxxxx látky Přípravek 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 xxxxxxxx xxx:
Kapalná xxxx xxxxx xxxxx. Xxxxxxxxxxxxxxx xxxxxx xxxxx Xxxx–1,4-xxxx-xxxxxxxx (ES 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 metoda (4)
|
Xxxxx všech xxxxx xxxxxxx xxxxx xxxxxx xxxx |
— |
Xxxx–1,4-xxxx-xxxxxxxx: 135 X Xxxx–1,3(4)-xxxx-xxxxxxxxx: 35 U Endo–1,4-beta-glukanáza: 40 X |
— |
|
4.&xxxx;xxxxx 2034 |
||||||||||||||||||||||
|
Xxxxxxx xxxxx xxxxxxx xxxxxx ke xxxxxx |
Xxxx–1,4-xxxx-xxxxxxxx: 216 X Xxxx–1,3(4)-xxxx-xxxxxxxxx: 56 X Xxxx–1,4-xxxx-xxxxxxxxx: 64 X |
||||||||||||||||||||||||||||||
|
Xxxxx krůt Selata (xxxxxxxxx) |
Xxxx–1,4-xxxx-xxxxxxxx: 270 X Xxxx–1,3(4)-xxxx-xxxxxxxxx: 70 X Xxxx–1,4-xxxx-xxxxxxxxx: 80 X |
||||||||||||||||||||||||||||||
(1)&xxxx;&xxxx;Xxxxx xxxxxxxx (X) endo-1,4-beta-xylanázy xx xxxxxxxx xxxxxx, xxxxx xxxxxx 1 xxxxxxxxx xxxxxxxxxxxx xxxxx (xxxxxxxxxx xxxxxx) za xxxxxx x&xxxx;xxxxxxxxxx xxxxxxxxxxxxx xxx xxxxxxx 40&xxxx;°X&xxxx;x&xxxx;xX&xxxx;5,0.
(2)&xxxx;&xxxx;Xxxxx xxxxxxxx (U) xxxx-1,3(4)-xxxx-xxxxxxxxx xx xxxxxxxx xxxxxx, xxxxx xxxxxx 1 xxxxxxxxx redukujícího xxxxx (xxxxxxxxxx xxxxxxx) xx xxxxxx x&xxxx;xxxxxxx beta-glukanu xxx teplotě 40&xxxx;°X&xxxx;x&xxxx;xX&xxxx;5,0.
(3)&xxxx;&xxxx;Xxxxx xxxxxxxx (X) endo-1,4-beta-glukanázy xx xxxxxxxx enzymu, xxxxx xxxxxx 1 xxxxxxxxx xxxxxxxxxxxx xxxxx (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 lze 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.