PROVÁDĚCÍ XXXXXXXX XXXXXX (XX) 2024/221
xx xxx 12.&xxxx;xxxxx 2024
o obnovení xxxxxxxx xxxxxxxxx z endo–1,4-beta-xylanázy, xxxx–1,3(4)-xxxx-xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx z Trichoderma xxxxxx XXXX 74444 jako xxxxxxxxx xxxxx xxx výkrm xxxxx xxxxx xxxxxxx, xxxxxxx xxxxx xxxxxxx xxxxxx xx snášce x&xxxx;xxxxxxxxx xxxxxx (držitel xxxxxxxx: XXX Xxxxxxxxxxx Xxxxxxxx) x&xxxx;x&xxxx;xxxxx xxxxxxxxxxx xxxxxxxx (XX) č. 403/2013
(Text x&xxxx;xxxxxxxx xxx XXX)
XXXXXXXX XXXXXX,
x&xxxx;xxxxxxx xx Xxxxxxx x&xxxx;xxxxxxxxx Xxxxxxxx unie,
s ohledem xx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;1831/2003 xx xxx 22.&xxxx;xxxx&xxxx;2003 x&xxxx;xxxxxxxxxxx xxxxxxx xxxxxxxxxxx xx výživě xxxxxx&xxxx;(1), x&xxxx;xxxxxxx xx xx.&xxxx;9 xxxx.&xxxx;2 uvedeného xxxxxxxx,
xxxxxxxx x&xxxx;xxxxx xxxxxxx:
(1) |
Xxxxxxxx (XX) x.&xxxx;1831/2003 stanoví xxxxxxxx xxxxxxxxxxx látek xxxxxxxxxxx ve xxxxxx xxxxxx x&xxxx;xxxxxx x&xxxx;xxxxxxx, xx xxxxxxx xxxxxxx 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 xxxxxx XXXX 74444 xxx xxxxxxx na xxxxx xxx xxxx doplňková xxxxx xxx xxxxx xxxxxxx, xxxxxxx x&xxxx;xxx xxxxxxxxx xxxxxx prováděcím xxxxxxxxx Komise (XX) 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 žádost x&xxxx;xxxxxxxx povolení 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 doplňkové látky. Xxxxxxx xxxxxx xxxx xxxxxx xxxxx x&xxxx;xxxxx x&xxxx;xxxxxxxxx požadovanými xxxxx xx.&xxxx;14 xxxx.&xxxx;2 nařízení (XX) č. 1831/2003. |
(4) |
Evropský xxxx xxx bezpečnost potravin (xxxx xxx „úřad“) xxxxxx ve xxxx xxxxxxxxxx xx xxx 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 xx xx stávajících xxxxxxxxxx xxxxxxxx použití i nadále xxxxxxxx xxx xxxxx xxxxxxx, xxxxxxx a pro 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 xxx xxxxxxxxx za xxxxx xxxxxxxxxxx senzibilizující xxxxxxx xxxxx. Vzhledem x&xxxx;xxxx, xx xxxxxx x&xxxx;xxxxxxxxx xxxxx, xxxxx xxxx xxxxxxx vyvodit xxxxx xxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxx xxxx x&xxxx;xxx xxxx xxxxxxxxxxxxx kůže. Xxxx xxxxxx xxxxx, xx x&xxxx;xxxxxxxxxxx x&xxxx;xxxxxxxxx povolení 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 XXXX 74444. Xxxx xxxxxxxxxxx xxxxxxxx xxxxxxxxx na monitorování xx xxxxxxx xx xxx za xxxxx. Xxxx xxxx ověřil xxxxxx x&xxxx;xxxxxxxx analýzy xxxxxxxxx xxxxx xxxxxxx xx krmiv xxxxxxxxxxx xxxxxxxxxx xxxxxxxxxx, zřízenou 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 a endo–1,4-beta-glukanázy z Trichoderma xxxxxx XXXX 74444 xxxxxxx xxxxxxxx xxxxxxxxx x&xxxx;xxxxxx&xxxx;5 nařízení (XX) x.&xxxx;1831/2003. Xxxxx xx xxxxxxxx xxxxxxx xxxxxxxxx xxxxx xxxx xxx xxxxxxxx. Vedle xxxx xx Komise domnívá, xx xx měla xxx xxxxxxx vhodná xxxxxxxx xxxxxxxx, xxx xx xxxxxxxxx xxxxxxxxxxx xxxxxxx xx xxxxxx xxxxxxxxx dané 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&xxxx;xxxx xxxxxxxxx xxxxx xx mělo xxx xxxxxxx xxxxxxxxx xxxxxxxx (EU) č. 403/2013. |
(7) |
Vzhledem x&xxxx;xxxx, xx xxxxxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxx změn 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, je vhodné xxxxxxxx xxxxxxxxx xxxxxx, xxxxx by xxxxxxxxxxx xxxxxxx xxxxxxxx připravit xx xx xxxxxx xxxxxx xxxxxxxxx xxxxxxxxxxxxx x&xxxx;xxxxxxxx xxxxxxxx. |
(8) |
Xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx jsou x&xxxx;xxxxxxx xx stanoviskem Xxxxxxx xxxxxx pro xxxxxxxx, xxxxxxx, potraviny x&xxxx;xxxxxx, |
XXXXXXX XXXX NAŘÍZENÍ:
Xxxxxx&xxxx;1
Xxxxxxxx xxxxxxxx
Xxxxxxxx xxxxxxxxx xxxxxxxxx v příloze, xxxxxxxxxxxx xx xxxxxxxxx xxxxxxxxxxx xxxxx „zootechnické xxxxxxxxx xxxxx“ a funkční xxxxxxx „xxxxx xxxxxxxxx stravitelnost“, xx xxxxxxxx xxxxx xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxx.
Článek 2
Změna prováděcího xxxxxxxx (XX) x.&xxxx;403/2013
Xxxxxxxxx nařízení (XX) x.&xxxx;403/2013 xx xxxx xxxxx:
1. |
xxxxxx&xxxx;1 xx xxxxxxx; |
2. |
xxxxxxx xx xxxxxxx. |
Článek 3
Přechodná xxxxxxxx
1.&xxxx;&xxxx;&xxxx;Xxxxxxxxx xxxxxxx x&xxxx;xxxxxxx x&xxxx;xxxxxxx xxxxxxxxxx xxxxx přípravek, xxxxxxxx x&xxxx;xxxxxxxx před xxxx 4.&xxxx;xxxxx 2024 x&xxxx;xxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx xxxx 4.&xxxx;xxxxx 2024, xxxxx být xxxxxx xxxxxxx na xxx x&xxxx;xxxxxxxxx až xx xxxxxxxxx stávajících xxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxx xxxxx x&xxxx;xxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxx uvedený x&xxxx;xxxxxxx, xxxxxxxx a označené xxxx 4. xxxxxx 2025 x&xxxx;xxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx 4. xxxxxx 2024, mohou xxx xxxxxxx xx xxx x&xxxx;xxxxxxxxx xx xx xxxxxxxxx xxxxxxxxxxx xxxxx.
Xxxxxx&xxxx;4
Xxxxx v platnost
Toto xxxxxxxx xxxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx xx vyhlášení x&xxxx;Xxxxxxx věstníku Evropské xxxx.
Toto xxxxxxxx xx xxxxxxx v celém rozsahu x&xxxx;xxxxx xxxxxxxxxx ve xxxxx xxxxxxxxx xxxxxxx.
X&xxxx;Xxxxxxx xxx 12.&xxxx;xxxxx 2024.
Xx Xxxxxx
xxxxxxxxxxx
Xxxxxx VON XXX 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 xx xxx 2.&xxxx;xxxxxx&xxxx;2013 o 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) jako xxxxxxxxx xxxxx pro xxxxx xxxxxxx, xxxxxxx x&xxxx;xxx odstavená xxxxxx x&xxxx;xxxxxx xx xxxx xxxxxxxx (XX) x.&xxxx;1259/2004, (XX) x.&xxxx;1206/2005 x&xxxx;(XX) x.&xxxx;1876/2006 (držitel xxxxxxxx XXX Nutritional Xxxxxxxx) (Xx.&xxxx;xxxx.&xxxx;X&xxxx;121, 3.5.2013, x.&xxxx;26).
(3)&xxxx;&xxxx; XXXX Journal 2023;21(6):8043.
PŘÍLOHA
Identifikační xxxxx xxxxxxxxx xxxxx |
Xxxxx xxxxxxxx xxxxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, xxxxxxxx xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx xxxxxxxxx xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx obsah |
Jiná xxxxxxxxxx |
Xxxxx xxxxxxxxx xxxxxxxx |
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Xxxxxxxx xxxxxxxx/xx kompletního xxxxxx x&xxxx;xxxxxx vlhkosti 12&xxxx;% |
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Xxxxxxxxx: xxxxxxxxxxxx doplňkové xxxxx. Xxxxxxx skupina: látky xxxxxxxxx xxxxxxxxxxxxx. |
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4x1602x |
XXX Nutritional 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 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 XXXX 74444 x&xxxx;xxxxxxx xxxxxxxx xxx:
Xxxxxxx nebo xxxxx forma. Charakteristika účinné 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 ATCC 74444 Xxxxxxxxxx metoda (4)
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Xxxxx xxxxx druhů xxxxxxx xxxxx xxxxxx xxxx |
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Xxxx–1,4-xxxx-xxxxxxxx: 135 U Endo–1,3(4)-beta-glukanáza: 35 X Xxxx–1,4-xxxx-xxxxxxxxx: 40 X |
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4.&xxxx;xxxxx 2034 |
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Xxxxxxx druhy xxxxxxx určené ke 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 (odstavená) |
Endo–1,4-beta-xylanáza: 270 X Xxxx–1,3(4)-xxxx-xxxxxxxxx: 70 X Xxxx–1,4-xxxx-xxxxxxxxx: 80 U |
(1) Jedna xxxxxxxx (X) xxxx-1,4-xxxx-xxxxxxxx xx xxxxxxxx enzymu, xxxxx uvolní 1 xxxxxxxxx xxxxxxxxxxxx cukru (xxxxxxxxxx xxxxxx) za xxxxxx z pšeničného xxxxxxxxxxxxx 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 množství xxxxxx, xxxxx uvolní 1 xxxxxxxxx xxxxxxxxxxxx cukru (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 (X) xxxx-1,4-xxxx-xxxxxxxxx xx xxxxxxxx xxxxxx, xxxxx uvolní 1 xxxxxxxxx redukujícího xxxxx (xxxxxxxxxx glukózy) xx xxxxxx z karboxymethylcelulosy xxx xxxxxxx 40 °C a pH 5,0.
(4) Podrobné xxxxxxxxx x&xxxx;xxxxxxxxxxxx xxxxxxxx lze xxxxxx xx xxxxxxxxxxx xxxxxxx xxxxxxxxxx laboratoře: xxxxx://xxxxx-xxxxxxxx-xxxxxx.xx.xxxxxx.xx/xxxx-xx-xxxx-xxxx-xxxxxxxxx/xxxx-xx-xxxxxxxxxxxxx/xxxx-xx-xxxxxxxxxx-xxxxxxx_xx.