XXXXXXXXX NAŘÍZENÍ XXXXXX (XX) 2024/221
ze dne 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 x&xxxx;Xxxxxxxxxxx xxxxxx XXXX 74444&xxxx;xxxx doplňkové xxxxx xxx výkrm xxxxx xxxxx xxxxxxx, xxxxxxx druhy xxxxxxx xxxxxx ke snášce x&xxxx;xxxxxxxxx xxxxxx (xxxxxxx xxxxxxxx: XXX Xxxxxxxxxxx Xxxxxxxx) x&xxxx;x&xxxx;xxxxx xxxxxxxxxxx xxxxxxxx (XX) č. 403/2013
(Text x&xxxx;xxxxxxxx xxx EHP)
EVROPSKÁ XXXXXX,
x&xxxx;xxxxxxx xx Xxxxxxx x&xxxx;xxxxxxxxx Xxxxxxxx unie,
s ohledem xx nařízení Xxxxxxxxxx xxxxxxxxxx a Rady (XX) x.&xxxx;1831/2003 ze dne 22.&xxxx;xxxx&xxxx;2003 x&xxxx;xxxxxxxxxxx xxxxxxx xxxxxxxxxxx xx xxxxxx xxxxxx&xxxx;(1), a zejména na xx.&xxxx;9 xxxx.&xxxx;2 xxxxxxxxx xxxxxxxx,
xxxxxxxx k těmto důvodům:
(1) |
Nařízení (XX) č. 1831/2003 xxxxxxx xxxxxxxx doplňkových xxxxx xxxxxxxxxxx xx xxxxxx xxxxxx a důvody x&xxxx;xxxxxxx, xx xxxxxxx xxxxxxx xx povolení xxxxxxx 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 z Trichoderma xxxxxx XXXX 74444 xxx xxxxxxx xx xxxxx xxx xxxx xxxxxxxxx xxxxx xxx xxxxx xxxxxxx, nosnice a pro xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxx Xxxxxx (EU) x.&xxxx;403/2013&xxxx;(2). |
(3) |
X&xxxx;xxxxxxx s čl. 14 xxxx.&xxxx;1 xxxxxxxx (XX) č. 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 doplňkové xxxxx. Xxxxxxx xxxxxx xxxx xxxxxx spolu s údaji x&xxxx;xxxxxxxxx xxxxxxxxxxxx xxxxx xx.&xxxx;14 xxxx.&xxxx;2 nařízení (XX) x.&xxxx;1831/2003. |
(4) |
Xxxxxxxx xxxx xxx xxxxxxxxxx xxxxxxxx (xxxx xxx „úřad“) xxxxxx xx svém xxxxxxxxxx xx dne 11.&xxxx;xxxxxx&xxxx;2023&xxxx;(3) k závěru, že 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 xx stávajících xxxxxxxxxx xxxxxxxx xxxxxxx x&xxxx;xxxxxx xxxxxxxx xxx výkrm xxxxxxx, xxxxxxx a pro xxxxxxxxx xxxxxx, spotřebitele x&xxxx;xxxxxxx xxxxxxxxx. 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 ATCC 74444 xx xxx xxx xxxxxxxxx za xxxxx xxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxx xxxxx. Vzhledem k tomu, xx nejsou x&xxxx;xxxxxxxxx xxxxx, nebyl xxxx xxxxxxx xxxxxxx xxxxx xxxxxxx potenciálu uvedeného xxxxxxxxx xxxxxxxx xxxxxxxxxx xxxx x&xxxx;xxx xxxx xxxxxxxxxxxxx xxxx. Úřad xxxxxx uvedl, že x&xxxx;xxxxxxxxxxx x&xxxx;xxxxxxxxx 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 z Trichoderma xxxxxx XXXX 74444. Xxxx xxxxxxxxxxx xxxxxxxx xxxxxxxxx na xxxxxxxxxxxx xx xxxxxxx xx xxx za nutné. Xxxx xxxx xxxxxx xxxxxx x&xxxx;xxxxxxxx analýzy xxxxxxxxx xxxxx xxxxxxx xx xxxxx předloženou xxxxxxxxxx xxxxxxxxxx, xxxxxxxx xxxxxxxxx (XX) č. 1831/2003. |
(5) |
Vzhledem x&xxxx;xxxx uvedeným xxxxxxxxxxxx xx Xxxxxx xxxxxxx, 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 xxxxxxx podmínky xxxxxxxxx x&xxxx;xxxxxx&xxxx;5 nařízení (XX) x.&xxxx;1831/2003. Proto by xxxxxxxx xxxxxxx xxxxxxxxx xxxxx xxxx xxx xxxxxxxx. Vedle xxxx xx Xxxxxx domnívá, xx xx xxxx xxx přijata vhodná xxxxxxxx xxxxxxxx, xxx xx zabránilo xxxxxxxxxxx xxxxxxx xx zdraví xxxxxxxxx dané doplňkové xxxxx. |
(6) |
X&xxxx;xxxxxxxx xxxxxxxx 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&xxxx;xxxx xxxxxxxxx xxxxx xx xxxx xxx změněno xxxxxxxxx xxxxxxxx (XX) x.&xxxx;403/2013. |
(7) |
Xxxxxxxx x&xxxx;xxxx, xx xxxxxxxxxxxx xxxxxx nevyžadují okamžité xxxxxxxxx xxxx 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 xxxxxx ATCC 74444, xx xxxxxx xxxxxxxx xxxxxxxxx xxxxxx, xxxxx xx xxxxxxxxxxx xxxxxxx xxxxxxxx připravit xx xx xxxxxx xxxxxx xxxxxxxxx xxxxxxxxxxxxx x&xxxx;xxxxxxxx povolení. |
(8) |
Opatření xxxxxxxxx xxxxx xxxxxxxxx xxxx x&xxxx;xxxxxxx xx stanoviskem Xxxxxxx výboru xxx xxxxxxxx, zvířata, xxxxxxxxx x&xxxx;xxxxxx, |
XXXXXXX XXXX NAŘÍZENÍ:
Xxxxxx&xxxx;1
Xxxxxxxx povolení
Povolení xxxxxxxxx xxxxxxxxx v příloze, náležejícího xx xxxxxxxxx doplňkových xxxxx „xxxxxxxxxxxx xxxxxxxxx xxxxx“ a funkční skupiny „xxxxx xxxxxxxxx xxxxxxxxxxxxx“, xx obnovuje xxxxx xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxx.
Xxxxxx&xxxx;2
Xxxxx xxxxxxxxxxx xxxxxxxx (XX) x.&xxxx;403/2013
Xxxxxxxxx xxxxxxxx (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 xxxxxxxxx, xxxxxxxx x&xxxx;xxxxxxxx xxxx dnem 4.&xxxx;xxxxx 2024 x&xxxx;xxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx xxxx 4.&xxxx;xxxxx 2024, xxxxx být nadále xxxxxxx xx trh x&xxxx;xxxxxxxxx xx xx xxxxxxxxx xxxxxxxxxxx zásob.
2. Krmné xxxxx x&xxxx;xxxxx xxxxxxxx xxxxxxxxxx přípravek xxxxxxx x&xxxx;xxxxxxx, xxxxxxxx a označené xxxx 4. xxxxxx 2025 x&xxxx;xxxxxxx s pravidly xxxxxxxx xxxx 4. xxxxxx 2024, xxxxx xxx uváděny na xxx x&xxxx;xxxxxxxxx až xx vyčerpání stávajících xxxxx.
Xxxxxx&xxxx;4
Xxxxx x&xxxx;xxxxxxxx
Xxxx nařízení xxxxxxxx v platnost xxxxxxxx xxxx xx xxxxxxxxx x&xxxx;Xxxxxxx xxxxxxxx Xxxxxxxx xxxx.
Xxxx xxxxxxxx je xxxxxxx x&xxxx;xxxxx rozsahu x&xxxx;xxxxx použitelné ve xxxxx xxxxxxxxx xxxxxxx.
X&xxxx;Xxxxxxx xxx 12.&xxxx;xxxxx 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 xxxxxxxx Komise (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 reesei (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) 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.
XXXXXXX
Xxxxxxxxxxxxx číslo xxxxxxxxx xxxxx |
Xxxxx xxxxxxxx xxxxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, chemický xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx kategorie xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxx xxxxxxxxxx |
Xxxxx xxxxxxxxx povolení |
||||||||||||||||||||||
Jednotky xxxxxxxx/xx xxxxxxxxxxx krmiva x&xxxx;xxxxxx vlhkosti 12&xxxx;% |
|||||||||||||||||||||||||||||||
Xxxxxxxxx: xxxxxxxxxxxx doplňkové xxxxx. Xxxxxxx xxxxxxx: látky 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 xxxxx Xxxxxxxxx x&xxxx;xxxx–1,4-xxxx-xxxxxxxx, endo–1,3(4)-beta-glukanázy x&xxxx;xxxx–1,4-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx reesei XXXX 74444 x&xxxx;xxxxxxx aktivity 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 ATCC 74444 Xxxxxxxxxx metoda (4)
|
Xxxxx xxxxx druhů 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 |
||||||||||||||||||||||
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 |
||||||||||||||||||||||||||||||
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 (U) xxxx-1,4-xxxx-xxxxxxxx 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 (X) xxxx-1,3(4)-xxxx-xxxxxxxxx xx xxxxxxxx xxxxxx, xxxxx xxxxxx 1 xxxxxxxxx redukujícího xxxxx (xxxxxxxxxx xxxxxxx) za xxxxxx z ječného xxxx-xxxxxxx xxx xxxxxxx 40&xxxx;°X&xxxx;x&xxxx;xX&xxxx;5,0.
(3)&xxxx;&xxxx;Xxxxx xxxxxxxx (U) xxxx-1,4-xxxx-xxxxxxxxx xx xxxxxxxx xxxxxx, xxxxx uvolní 1 xxxxxxxxx xxxxxxxxxxxx cukru (xxxxxxxxxx xxxxxxx) xx xxxxxx z karboxymethylcelulosy xxx xxxxxxx 40 °C a pH 5,0.
(4) Podrobné xxxxxxxxx x&xxxx;xxxxxxxxxxxx xxxxxxxx xxx xxxxxx na xxxxxxxxxxx xxxxxxx referenční laboratoře: xxxxx://xxxxx-xxxxxxxx-xxxxxx.xx.xxxxxx.xx/xxxx-xx-xxxx-xxxx-xxxxxxxxx/xxxx-xx-xxxxxxxxxxxxx/xxxx-xx-xxxxxxxxxx-xxxxxxx_xx.