XXXXXXXXX XXXXXXXX XXXXXX (XX) 2024/221
xx dne 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 xxxxxxxxx xxxxx xxx výkrm xxxxx druhů xxxxxxx, xxxxxxx druhy xxxxxxx xxxxxx ke xxxxxx x&xxxx;xxxxxxxxx xxxxxx (xxxxxxx xxxxxxxx: DSM 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 na Smlouvu x&xxxx;xxxxxxxxx Xxxxxxxx xxxx,
x&xxxx;xxxxxxx xx nařízení Evropského xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;1831/2003 xx xxx 22.&xxxx;xxxx&xxxx;2003 o doplňkových látkách xxxxxxxxxxx xx xxxxxx xxxxxx&xxxx;(1), a zejména na xx.&xxxx;9 odst. 2 xxxxxxxxx xxxxxxxx,
xxxxxxxx k těmto xxxxxxx:
(1) |
Xxxxxxxx (XX) x.&xxxx;1831/2003 xxxxxxx xxxxxxxx doplňkových xxxxx xxxxxxxxxxx xx výživě xxxxxx x&xxxx;xxxxxx x&xxxx;xxxxxxx, xx xxxxxxx xxxxxxx xx povolení xxxxxxx x&xxxx;xxxxxxxx. |
(2) |
Xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, 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 pro výkrm xxxxxxx, nosnice 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 (ES) x.&xxxx;1831/2003 xxxx xxxxxx žádost 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 reesei 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 xxxxxxxxxx potravin (xxxx xxx „xxxx“) xxxxxx xx svém xxxxxxxxxx xx dne 11.&xxxx;xxxxxx&xxxx;2023&xxxx;(3) k závěru, xx 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 xx xx stávajících xxxxxxxxxx xxxxxxxx xxxxxxx i nadále xxxxxxxx xxx xxxxx xxxxxxx, xxxxxxx x&xxxx;xxx xxxxxxxxx xxxxxx, xxxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxxxx. Úřad xxxxxx dospěl k závěru, xx 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 xx xxx xxx xxxxxxxxx za xxxxx xxxxxxxxxxx senzibilizující xxxxxxx xxxxx. Xxxxxxxx x&xxxx;xxxx, xx xxxxxx x&xxxx;xxxxxxxxx xxxxx, xxxxx úřad xxxxxxx xxxxxxx závěr xxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxxxx podráždění xxxx a očí nebo xxxxxxxxxxxxx xxxx. 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 nepovažoval xxxxxxxx xxxxxxxxx xx xxxxxxxxxxxx xx uvedení xx xxx za xxxxx. Xxxx xxxx ověřil xxxxxx o metodách xxxxxxx xxxxxxxxx xxxxx xxxxxxx xx krmiv xxxxxxxxxxx xxxxxxxxxx xxxxxxxxxx, xxxxxxxx xxxxxxxxx (ES) x.&xxxx;1831/2003. |
(5) |
Xxxxxxxx x&xxxx;xxxx xxxxxxxx skutečnostem 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 ATCC 74444 xxxxxxx xxxxxxxx xxxxxxxxx x&xxxx;xxxxxx&xxxx;5 xxxxxxxx (ES) x.&xxxx;1831/2003. Xxxxx by xxxxxxxx xxxxxxx xxxxxxxxx xxxxx xxxx xxx xxxxxxxx. Vedle xxxx xx Xxxxxx domnívá, xx xx xxxx xxx xxxxxxx vhodná xxxxxxxx xxxxxxxx, aby xx xxxxxxxxx nepříznivým xxxxxxx xx xxxxxx xxxxxxxxx xxxx doplňkové xxxxx. |
(6) |
X&xxxx;xxxxxxxx obnovení xxxxxxxx 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;xxxx doplňkové xxxxx xx xxxx xxx změněno prováděcí xxxxxxxx (XX) x.&xxxx;403/2013. |
(7) |
Xxxxxxxx x&xxxx;xxxx, xx xxxxxxxxxxxx xxxxxx xxxxxxxxxx okamžité xxxxxxxxx změn x&xxxx;xxxxxxxxxx xxx xxxxxxxx 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, je xxxxxx xxxxxxxx xxxxxxxxx období, xxxxx by xxxxxxxxxxx xxxxxxx xxxxxxxx připravit xx xx xxxxxx xxxxxx požadavků xxxxxxxxxxxxx x&xxxx;xxxxxxxx xxxxxxxx. |
(8) |
Xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxx x&xxxx;xxxxxxx xx stanoviskem Xxxxxxx xxxxxx xxx xxxxxxxx, xxxxxxx, potraviny x&xxxx;xxxxxx, |
XXXXXXX XXXX XXXXXXXX:
Xxxxxx&xxxx;1
Xxxxxxxx xxxxxxxx
Xxxxxxxx xxxxxxxxx xxxxxxxxx v příloze, xxxxxxxxxxxx xx xxxxxxxxx xxxxxxxxxxx xxxxx „xxxxxxxxxxxx xxxxxxxxx xxxxx“ x&xxxx;xxxxxxx xxxxxxx „xxxxx xxxxxxxxx stravitelnost“, xx xxxxxxxx podle xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxx.
Článek 2
Změna xxxxxxxxxxx xxxxxxxx (XX) č. 403/2013
Prováděcí xxxxxxxx (XX) x.&xxxx;403/2013 xx xxxx takto:
1. |
článek 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 platnými xxxx xxxx 4.&xxxx;xxxxx 2024, xxxxx být nadále xxxxxxx xx trh x&xxxx;xxxxxxxxx xx xx xxxxxxxxx xxxxxxxxxxx xxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxx xxxxx x&xxxx;xxxxx suroviny xxxxxxxxxx xxxxxxxxx xxxxxxx x&xxxx;xxxxxxx, vyrobené x&xxxx;xxxxxxxx xxxx 4. únorem 2025 x&xxxx;xxxxxxx s pravidly xxxxxxxx xxxx 4. xxxxxx 2024, mohou xxx xxxxxxx na xxx x&xxxx;xxxxxxxxx xx xx vyčerpání stávajících xxxxx.
Článek 4
Vstup v platnost
Toto xxxxxxxx xxxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx xx xxxxxxxxx x&xxxx;Xxxxxxx xxxxxxxx Xxxxxxxx xxxx.
Toto xxxxxxxx je xxxxxxx x&xxxx;xxxxx xxxxxxx x&xxxx;xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx xxxxxxx.
X&xxxx;Xxxxxxx xxx 12. ledna 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 nařízení Xxxxxx (XX) x.&xxxx;403/2013 ze xxx 2.&xxxx;xxxxxx&xxxx;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 xxxxx pro xxxxx xxxxxxx, nosnice x&xxxx;xxx xxxxxxxxx xxxxxx x&xxxx;xxxxxx xx mění xxxxxxxx (ES) č. 1259/2004, (XX) x.&xxxx;1206/2005 a (ES) x.&xxxx;1876/2006 (xxxxxxx xxxxxxxx XXX Nutritional 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 číslo xxxxxxxxx xxxxx |
Xxxxx držitele povolení |
Doplňková xxxxx |
Xxxxxxx, chemický 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 xxxxxxxxxxx xxxxxx x&xxxx;xxxxxx xxxxxxxx 12&xxxx;% |
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Xxxxxxxxx: xxxxxxxxxxxx xxxxxxxxx xxxxx. Xxxxxxx skupina: xxxxx xxxxxxxxx xxxxxxxxxxxxx. |
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4x1602x |
XXX Nutritional 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 doplňkové 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 nebo 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)
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Xxxxx všech druhů xxxxxxx kromě výkrmu 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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Všechny 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 (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 množství xxxxxx, xxxxx xxxxxx 1 xxxxxxxxx xxxxxxxxxxxx xxxxx (xxxxxxxxxx xylózy) za xxxxxx x&xxxx;xxxxxxxxxx xxxxxxxxxxxxx xxx teplotě 40 °C a pH 5,0.
(2) Jedna xxxxxxxx (X) xxxx-1,3(4)-xxxx-xxxxxxxxx xx množství enzymu, xxxxx xxxxxx 1 xxxxxxxxx xxxxxxxxxxxx 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 množství xxxxxx, xxxxx xxxxxx 1 xxxxxxxxx xxxxxxxxxxxx cukru (xxxxxxxxxx glukózy) xx 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 xxxxxxxxxx xxxxxxxxxx: xxxxx://xxxxx-xxxxxxxx-xxxxxx.xx.xxxxxx.xx/xxxx-xx-xxxx-xxxx-xxxxxxxxx/xxxx-xx-xxxxxxxxxxxxx/xxxx-xx-xxxxxxxxxx-xxxxxxx_xx.