XXXXXXXXX XXXXXXXX XXXXXX (XX) 2025/2046
xx dne 10.&xxxx;xxxxx 2025,
kterým xx xxxx xxxxxxxxx xxxxxxxx (XX)&xxxx;2015/1486, xxxxx xxx x&xxxx;xxxxxxxx xxxxxxxx xxxxxxxxxxxxxx xxxx xxxxxxxxx xxxxx xxx některé xxxxxxxxx xxxxxxx, xxxxxxxxx ryb x&xxxx;xxxxxxxxx xxxxx
(Xxxx x&xxxx;xxxxxxxx xxx EHP)
EVROPSKÁ XXXXXX,
x&xxxx;xxxxxxx xx Smlouvu o fungování Xxxxxxxx xxxx,
x&xxxx;xxxxxxx xx xxxxxxxx Evropského parlamentu x&xxxx;Xxxx (ES) č. 1831/2003 xx xxx 22.&xxxx;xxxx 2003 x&xxxx;xxxxxxxxxxx xxxxxxx xxxxxxxxxxx ve xxxxxx xxxxxx&xxxx;(1), x&xxxx;xxxxxxx na xx.&xxxx;9 odst. 2 x&xxxx;xx.&xxxx;13 xxxx.&xxxx;2 xxxxxxxxx xxxxxxxx,
xxxxxxxx x&xxxx;xxxxx důvodům:
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(1) |
Nařízení (XX) x.&xxxx;1831/2003 xxxxxxx xxxxxxxx xxxxxxxxxxx látek xxxxxxxxxxx xx xxxxxx xxxxxx x&xxxx;xxxxxx a postupy, xx xxxxxxx xxxxxxx xx xxxxxxxx xxxxxxx x&xxxx;xxxx. |
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(2) |
Xxxxxxxxxxxxx xxx xxxxxxx prováděcím xxxxxxxxx Xxxxxx (XX)&xxxx;2015/1486&xxxx;(2) xx xxxx xxxxxx xxx xxxx xxxxxxxxx xxxxx xxx xxxxxxx xxxxxxxxx xxxxxxx, okrasných xxx a okrasných xxxxx. |
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(3) |
X&xxxx;xxxxxxx x&xxxx;xx.&xxxx;13 odst. 1 xxxxxxxx (XX) x.&xxxx;1831/2003 xxxxxxxx Xxxxxx Evropský xxxx xxx bezpečnost xxxxxxxx (xxxx xxx „xxxx“) x&xxxx;xxxxxx xxxxxxxxxx, zda xx povolení xxxxxxxxxxxxxx xxxx xxxxxxxxx xxxxx xxxxxx splňovalo podmínky xxxxxxxxx v článku 5 xxxxxxxx (XX) x.&xxxx;1831/2003, xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xxxx xxxxxxx. Xxxxx xxxxxxx x&xxxx;xxxxxxxx xxxxxx xxxxxxxxx xxxxxxx fermentací xxxxxx Xxxxxxxx xxxxxxxxxx XXX 146148. Žadatel xxxxx, xx xxxxxxxxxxxxx, xxx syntetický, nebo xxxxxxxx xxxxxxxxxx, bude xxxxxx na xxx xxxxx jako xxxxxxxxx. X&xxxx;xxxxxxx xxxx přiloženy xxxxxxxxx xxxxxxxx xxxxx. |
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(4) |
Xxxx xxxxxx ve xxxx xxxxxxxxxx xx xxx 26.&xxxx;xxxxxxxxx 2024 (3) x&xxxx;xxxxxx, xx xxxxxxxxx kanthaxanthinu x&xxxx;xxxxxxxxxx xxxxxx Yarrowia xxxxxxxxxx CBS 146148 xx xx xxxxxxxxxxx xxxxxxxxxx xxxxxxxx použití xxxxxxxx xxx cílové xxxxx, xxxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxxxx. Xxxxxx xxxxxx x&xxxx;xxxxxx, xx vzhledem x&xxxx;xxxxxxxxxxx údajů o přípravku xxxxxxxxxxxxxx xxxxxx xxxxx xxxxxx x&xxxx;xxxxxx xxxxxxx xxxxxxx xxxx xxxxxxxxxxx xxx xxxxxxxxx. Úřad xxxx dospěl k závěru, xx xxxxxxxxxxxxx x&xxxx;xxxxxxxxxx xxxxxx Xxxxxxxx xxxxxxxxxx XXX 146148 xx xxxxxx jako barvivo x&xxxx;xxxxxxxx xxx xxxxx xxxxx a výkrm xxxxxxxxxxx xxxxx drůbeže, xxxxxxx x&xxxx;xxxxxx drůbeže, okrasné xxxx a okrasné xxxxxxx. Xxxxx doporučil xxxxxxx xxxxx ustanovení stávajícího xxxxxxxx, xxxxx jde x&xxxx;xxxx přípravku kanthaxanthinu x&xxxx;xxxxxx xxxxxxxxxxx. |
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(5) |
Xxxxxxxx k výše xxxxxxxx xxxxxxxxxxxx xx Xxxxxx xxxxxxx, xx xxxxxxxxx xxxxxxxxxxxxxx xxxxx xxxxxxx xxxxxxxx stanovené x&xxxx;xxxxxx&xxxx;5 xxxxxxxx (ES) x.&xxxx;1831/2003, když se xxxxx xxxxxxxx povolení xxxxxxxxx nového xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxxx Xxxxxxxx lipolytica CBS 146148. Xxxxx toho xx ustanovení xxxxxxxxxxx xxxxxxxx (XX)&xxxx;2015/1486 xxxxxxxx xx směsi xxxxxxxxx xxxxxxxxxxxxxx s jinými xxxxxxxxxxx xxxx xxx upraveno x&xxxx;xxxxxxx x&xxxx;xxxxxxxxxxx xxxxx. Xxxxxxxxx nařízení (EU) 2015/1486 xx xxxxx xxxx xxx xxxxxxxxxxxxx xxxxxxxx xxxxxxx. |
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(6) |
X&xxxx;xxxxx xxxxx xxxxxxxx xx mělo být xxxxxxxxxxxxxx z fermentace xxxxxx Xxxxxxxx xxxxxxxxxx CBS 146148 xxxxxxxxx nové xxxxxxxxxxxxx xxxxx. |
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(7) |
Xxxxxxxx xxxxxxxxx xxxxx nařízením xxxx x&xxxx;xxxxxxx xx xxxxxxxxxxx Xxxxxxx xxxxxx pro xxxxxxxx, xxxxxxx, potraviny x&xxxx;xxxxxx, |
XXXXXXX TOTO XXXXXXXX:
Xxxxxx&xxxx;1
Xxxxx xxxxxxxxxxx xxxxxxxx (XX)&xxxx;2015/1486
Xxxxxxx prováděcího nařízení (XX)&xxxx;2015/1486 xx xxxxxxxxx xxxxxxxx xxxxxx prováděcího xxxxxxxx.
Xxxxxx&xxxx;2
Xxxxx v platnost
Toto nařízení xxxxxxxx v platnost xxxxxxxx xxxx xx xxxxxxxxx x&xxxx;Xxxxxxx xxxxxxxx Xxxxxxxx xxxx.
Xxxx xxxxxxxx xx xxxxxxx x&xxxx;xxxxx xxxxxxx x&xxxx;xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx xxxxxxx.
X&xxxx;Xxxxxxx xxx 10.&xxxx;xxxxx 2025.
Za Xxxxxx
xxxxxxxxxxx
Xxxxxx XXX XXX XXXXX
(1)&xxxx;&xxxx; Xx.&xxxx;xxxx.&xxxx;X&xxxx;268, 18.10.2003, x.&xxxx;29, Úř. věst. L 268, 18.10.2003, x.&xxxx;29.
(2)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Komise (XX)&xxxx;2015/1486 xx xxx 2.&xxxx;xxxx 2015 x&xxxx;xxxxxxxx xxxxxxxxxxxxxx xxxx xxxxxxxxx xxxxx xxx některé xxxxxxxxx xxxxxxx, okrasných xxx x&xxxx;xxxxxxxxx xxxxx (Xx.&xxxx;xxxx.&xxxx;X&xxxx;229, 3.9.2015, x.&xxxx;5; XXX: Xx.&xxxx;xxxx.&xxxx;X&xxxx;229, 3.9.2015, x.&xxxx;5).
(3)&xxxx;&xxxx;XXXX Xxxxxxx, 23(1), x9134. xxxxx://xxx.xxx/10.2903/x.xxxx.2025.9134.
XXXXXXX
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Xxxxxxxxxxxxx xxxxx doplňkové xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, chemický xxxxxx, popis, xxxxxxxxxx xxxxxx |
Xxxx xxxx xxxxxxxxx xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxx ustanovení |
Maximální limity xxxxxxx |
Xxxxx xxxxxxxxx xxxxxxxx |
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xx xxxxxx xxxxx / xx kompletního krmiva x&xxxx;xxxxxx xxxxxxxx 12&xxxx;% |
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Xxxxxxxxx: xxxxxxxxxx xxxxxxxxx xxxxx. Xxxxxxx xxxxxxx: barviva: xx)&xxxx;xxxxx, xxxxx xxx xxxxxxxxx xxxxxxx dodávají xxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxx |
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2x161&xxxx;x |
Xxxxxxxxxxxxx |
Xxxxxxx xxxxxxxxx xxxxx Xxxxxxxxxxxxx Xxxxxxxxxxxxxx-xxxx (TPPO) ≤&xxxx;100&xxxx;xx/xx Xxxxxxxxxxxxx ≤&xxxx;600&xxxx;xx/xx Xxxxxxxxxxxxxxx xxxxxx xxxxx
Xxxxxxx: Xxxxx: xxxxxxxxx 96&xxxx;% Xxxxxxxxxxx xxxx xxx xxxxxxxxxxxxx: xx xxxx xxx 5&xxxx;% celkového xxxxxxxx xxxxxx. Xxxxxxxxxx xxxxxx (1) Xxx kvantifikaci kanthaxanthinu x&xxxx;xxxxxxxxx xxxxx: xxxxxxxxxxxxxxxxx xxx 426&xxxx;xx. Xxx xxxxxxxxxxxx xxxxxxxxxxxxxx v premixech x&xxxx;xxxxxxxx: xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxx xx normální xxxx x&xxxx;XXX xxxxxxxxxx (XX-XXXX-XXX, 466&xxxx;xx). |
Xxxxx kuřat x&xxxx;xxxxx xxxxxxxxxxx xxxxx drůbeže |
– |
– |
25 |
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Xxxxxx 15&xxxx;xx xxxxxxxxxxxxxx/xx xxxxx (xxxxx tkáň) a 2,5 mg xxxxxxxxxxxxxx/xx xxxx/xxxx (xxxxx xxxx) Xxxxxxx 30 mg kanthaxanthinu/kg xxxxxxx (xxxxx tkáň) |
23.9.2025 |
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Nosnice x&xxxx;xxxxxx xxxxxxx |
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– |
8 |
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2x161xx |
Xxxxxxxxxxxxx |
Xxxxxxx xxxxxxxxx xxxxx Xxxxxxxxx xxxxxxxxxx xxxxxxx 10 % kanthaxanthinu Dichlormethan ≤&xxxx;80&xxxx;xx/xx Xxxxxxxxxxxxxxx účinné xxxxx
– Xxxxxxx: Xxxxx: xxxxxxx 96 % xxxxxxxxx xxxxxxxx xxxxxx (xxxxxxxxx jako xxxxxxxxxxxxx) Xxxxxxxxxxx xxxx xxx kanthaxanthin: ne xxxx xxx 5&xxxx;% xxxxxxxxx xxxxxxxx xxxxxx. Xxxxxxxxxx xxxxxx (1) Pro kvantifikaci xxxxxxxxxxxxxx v doplňkové xxxxx: xxxxxxxxxxxxxxxxx xxx 426 nm. Pro xxxxxxxxxxxx kanthaxanthinu v premixech x&xxxx;xxxxxxxx: vysokoúčinná xxxxxxxxxx xxxxxxxxxxxxxx na xxxxxxxx xxxx x&xxxx;XXX xxxxxxxxxx (XX-XXXX-XXX, 466&xxxx;xx). |
Xxxxx xxxxx x&xxxx;xxxxx xxxxxxxxxxx xxxxx xxxxxxx |
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– |
25 |
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Xxxxxx 15&xxxx;xx xxxxxxxxxxxxxx/xx xxxxx (xxxxx xxxx) x&xxxx;2,5&xxxx;xx xxxxxxxxxxxxxx/xx xxxx/xxxx (xxxxx xxxx) Xxxxxxx 30&xxxx;xx xxxxxxxxxxxxxx/xx xxxxxxx (xxxxx xxxx) |
23.9.2025 |
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Xxxxxxx x&xxxx;xxxxxx xxxxxxx |
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8 |
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Xxxxxxxxxxxxx xxxxx xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, xxxxxxxx xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx xxxxxxxxx xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxx xxxxxxxxxx |
Xxxxxxxxx xxxxxx xxxxxxx |
Xxxxx platnosti povolení |
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mg xxxxxx xxxxx / xx xxxxxxxxxxx krmiva x&xxxx;xxxxxx vlhkosti 12&xxxx;% |
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Xxxxxxxxx: xxxxxxxxxx xxxxxxxxx xxxxx. Xxxxxxx skupina: xxxxxxx: xxx)&xxxx;xxxxx, xxxxx mají xxxxxxxxx xxxx na xxxxxxxx okrasných xxx xxxx ptáků |
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2a161 g |
Kanthaxanthin |
Složení doplňkové xxxxx Kanthaxanthin Trifenylfosfin-oxid (TPPO) ≤&xxxx;100&xxxx;xx/xx Xxxxxxxxxxxxx ≤ 600 mg/kg Charakteristika xxxxxx xxxxx
– Xxxxxxx: Xxxxx: xxxxxxxxx 96 % Karotenoidy xxxx xxx xxxxxxxxxxxxx: xx xxxx xxx 5 % xxxxxxxxx xxxxxxxx barviv. Analytická xxxxxx (2) Pro xxxxxxxxxxxx xxxxxxxxxxxxxx v doplňkové xxxxx: xxxxxxxxxxxxxxxxx xxx 426&xxxx;xx. Xxx xxxxxxxxxxxx xxxxxxxxxxxxxx x&xxxx;xxxxxxxxx x&xxxx;xxxxxxxx: xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxx na xxxxxxxx fázi x&xxxx;XXX xxxxxxxxxx (XX-XXXX-XXX, 466&xxxx;xx). |
Xxxxxxx xxxx x&xxxx;xxxxxxx xxxxx xxxxx okrasných plemenných xxxxxx. |
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– |
100 |
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23.9.2025 |
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Xxxxxxx plemenné xxxxxxx |
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– |
8 |
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2x161xx |
Xxxxxxxxxxxxx |
Xxxxxxx xxxxxxxxx látky Xxxxxxxxx xxxxxxxxxx xxxxxxx 10&xxxx;% xxxxxxxxxxxxxx Xxxxxxxxxxxxx ≤&xxxx;80&xxxx;xx/xx Xxxxxxxxxxxxxxx xxxxxx xxxxx
– Čistota: Obsah: nejméně 96&xxxx;% xxxxxxxxx xxxxxxxx xxxxxx (xxxxxxxxx jako xxxxxxxxxxxxx) Xxxxxxxxxxx xxxx než xxxxxxxxxxxxx: xx xxxx xxx 5&xxxx;% xxxxxxxxx množství xxxxxx. Xxxxxxxxxx xxxxxx (2) Xxx xxxxxxxxxxxx xxxxxxxxxxxxxx x&xxxx;xxxxxxxxx xxxxx: xxxxxxxxxxxxxxxxx xxx 426 nm. Pro xxxxxxxxxxxx xxxxxxxxxxxxxx x&xxxx;xxxxxxxxx x&xxxx;xxxxxxxx: xxxxxxxxxxxx kapalinová xxxxxxxxxxxxxx xx normální xxxx x&xxxx;XXX detektorem (XX-XXXX-XXX, 466&xxxx;xx). |
Xxxxxxx xxxx x&xxxx;xxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxxxx xxxxxx. |
– |
– |
100 |
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23.9.2025 |
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Okrasné xxxxxxxx xxxxxxx |
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– |
8 |
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(1)&xxxx;&xxxx;Xxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxxxxx xxxxxxxx xxx xxxxxx na xxxxxxxxxxx xxxxxxx xxxxxxxxxx laboratoře: xxxxx://xxxxx-xxxxxxxx-xxxxxx.xx.xxxxxx.xx/xxxx-xx-xxxx-xxxx-xxxxxxxxx/xxxx-xx-xxxxxxxxxxxxx/xxxx-xx-xxxxxxxxxx-xxxxxxx_xx.
(2)&xxxx;&xxxx;Xxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxxxxx xxxxxxxx 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.