PROVÁDĚCÍ XXXXXXXX KOMISE (XX) 2025/2046
xx dne 10.&xxxx;xxxxx 2025,
kterým xx xxxx xxxxxxxxx xxxxxxxx (XX)&xxxx;2015/1486, pokud xxx x&xxxx;xxxxxxxx xxxxxxxx kanthaxanthinu xxxx xxxxxxxxx xxxxx xxx xxxxxxx kategorie xxxxxxx, xxxxxxxxx xxx x&xxxx;xxxxxxxxx xxxxx
(Xxxx s významem xxx EHP)
EVROPSKÁ XXXXXX,
x&xxxx;xxxxxxx xx Xxxxxxx o fungování Xxxxxxxx xxxx,
x&xxxx;xxxxxxx xx xxxxxxxx Xxxxxxxxxx parlamentu x&xxxx;Xxxx (XX) x.&xxxx;1831/2003 xx xxx 22. září 2003 o doplňkových látkách xxxxxxxxxxx xx xxxxxx xxxxxx&xxxx;(1), a zejména xx xx.&xxxx;9 odst. 2 x&xxxx;xx.&xxxx;13 xxxx.&xxxx;2 xxxxxxxxx xxxxxxxx,
xxxxxxxx x&xxxx;xxxxx xxxxxxx:
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(1) |
Xxxxxxxx (ES) x.&xxxx;1831/2003 xxxxxxx xxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxx xx xxxxxx zvířat x&xxxx;xxxxxx x&xxxx;xxxxxxx, xx xxxxxxx xxxxxxx xx xxxxxxxx xxxxxxx x&xxxx;xxxx. |
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(2) |
Xxxxxxxxxxxxx xxx xxxxxxx xxxxxxxxxx xxxxxxxxx Xxxxxx (XX)&xxxx;2015/1486&xxxx;(2) xx dobu xxxxxx xxx xxxx doplňková xxxxx xxx některé xxxxxxxxx xxxxxxx, okrasných xxx x&xxxx;xxxxxxxxx xxxxx. |
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(3) |
X&xxxx;xxxxxxx x&xxxx;xx.&xxxx;13 xxxx.&xxxx;1 xxxxxxxx (XX) x.&xxxx;1831/2003 požádala Xxxxxx Xxxxxxxx xxxx xxx bezpečnost potravin (xxxx jen „úřad“) x&xxxx;xxxxxx xxxxxxxxxx, zda xx xxxxxxxx xxxxxxxxxxxxxx xxxx xxxxxxxxx xxxxx xxxxxx splňovalo podmínky xxxxxxxxx x&xxxx;xxxxxx&xxxx;5 xxxxxxxx (XX) x.&xxxx;1831/2003, xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xxxx xxxxxxx. Xxxxx xxxxxxx x&xxxx;xxxxxxxx xxxxxx xxxxxxxxx postupu xxxxxxxxxx xxxxxx Xxxxxxxx xxxxxxxxxx XXX 146148. Žadatel xxxxx, xx xxxxxxxxxxxxx, xxx xxxxxxxxxx, xxxx xxxxxxxx xxxxxxxxxx, bude xxxxxx xx xxx xxxxx jako přípravek. 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) k závěru, xx xxxxxxxxx kanthaxanthinu x&xxxx;xxxxxxxxxx pomocí Xxxxxxxx xxxxxxxxxx XXX 146148 xx xx xxxxxxxxxxx xxxxxxxxxx xxxxxxxx použití xxxxxxxx xxx xxxxxx xxxxx, xxxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxxxx. Xxxxxx xxxxxx x&xxxx;xxxxxx, xx vzhledem x&xxxx;xxxxxxxxxxx xxxxx o přípravku xxxxxxxxxxxxxx nebylo xxxxx xxxxxx k žádným xxxxxxx xxxxxxx xxxx xxxxxxxxxxx xxx xxxxxxxxx. Xxxx xxxx xxxxxx x&xxxx;xxxxxx, xx xxxxxxxxxxxxx x&xxxx;xxxxxxxxxx xxxxxx Xxxxxxxx xxxxxxxxxx XXX 146148 je xxxxxx xxxx xxxxxxx x&xxxx;xxxxxxxx xxx xxxxx xxxxx x&xxxx;xxxxx xxxxxxxxxxx xxxxx xxxxxxx, xxxxxxx x&xxxx;xxxxxx drůbeže, xxxxxxx xxxx x&xxxx;xxxxxxx xxxxxxx. Xxxxx xxxxxxxxx xxxxxxx xxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxx, xxxxx jde x&xxxx;xxxx xxxxxxxxx xxxxxxxxxxxxxx x&xxxx;xxxxxx karotenoidy. |
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(5) |
Vzhledem k výše xxxxxxxx xxxxxxxxxxxx se Xxxxxx xxxxxxx, xx xxxxxxxxx xxxxxxxxxxxxxx stále xxxxxxx xxxxxxxx xxxxxxxxx x&xxxx;xxxxxx&xxxx;5 nařízení (ES) x.&xxxx;1831/2003, xxxx xx xxxxx xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxx výrobního xxxxxxx fermentací xxxxxx Xxxxxxxx xxxxxxxxxx XXX 146148. Xxxxx xxxx xx xxxxxxxxxx xxxxxxxxxxx xxxxxxxx (XX)&xxxx;2015/1486 xxxxxxxx xx směsi xxxxxxxxx xxxxxxxxxxxxxx s jinými xxxxxxxxxxx xxxx xxx xxxxxxxx x&xxxx;xxxxxxx x&xxxx;xxxxxxxxxxx úřadu. Xxxxxxxxx xxxxxxxx (XX)&xxxx;2015/1486 xx proto mělo xxx odpovídajícím xxxxxxxx xxxxxxx. |
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(6) |
X&xxxx;xxxxx lepší xxxxxxxx xx mělo být xxxxxxxxxxxxxx x&xxxx;xxxxxxxxxx xxxxxx Xxxxxxxx lipolytica XXX 146148 přiděleno xxxx xxxxxxxxxxxxx xxxxx. |
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(7) |
Xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx jsou x&xxxx;xxxxxxx xx stanoviskem Xxxxxxx xxxxxx xxx xxxxxxxx, xxxxxxx, xxxxxxxxx x&xxxx;xxxxxx, |
XXXXXXX XXXX XXXXXXXX:
Xxxxxx&xxxx;1
Xxxxx prováděcího xxxxxxxx (XX)&xxxx;2015/1486
Xxxxxxx xxxxxxxxxxx nařízení (XX)&xxxx;2015/1486 xx xxxxxxxxx xxxxxxxx xxxxxx xxxxxxxxxxx xxxxxxxx.
Xxxxxx&xxxx;2
Xxxxx x&xxxx;xxxxxxxx
Xxxx nařízení xxxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx xx xxxxxxxxx x&xxxx;Xxxxxxx xxxxxxxx Xxxxxxxx xxxx.
Xxxx xxxxxxxx xx xxxxxxx v celém rozsahu x&xxxx;xxxxx xxxxxxxxxx xx xxxxx členských státech.
V Bruselu xxx 10.&xxxx;xxxxx 2025.
Xx Xxxxxx
xxxxxxxxxxx
Xxxxxx VON DER XXXXX
(1)&xxxx;&xxxx; Xx.&xxxx;xxxx.&xxxx;X&xxxx;268, 18.10.2003, x.&xxxx;29, Xx.&xxxx;xxxx.&xxxx;X&xxxx;268, 18.10.2003, x.&xxxx;29.
(2)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Xxxxxx (XX)&xxxx;2015/1486 xx xxx 2.&xxxx;xxxx 2015 x&xxxx;xxxxxxxx xxxxxxxxxxxxxx xxxx doplňkové xxxxx xxx xxxxxxx 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. https://doi.org/10.2903/j.efsa.2025.9134.
XXXXXXX
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Xxxxxxxxxxxxx xxxxx doplňkové xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, chemický xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx xxxxxxxxx xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxx xxxxxxxxxx |
Xxxxxxxxx xxxxxx xxxxxxx |
Xxxxx xxxxxxxxx xxxxxxxx |
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xx xxxxxx látky / xx xxxxxxxxxxx xxxxxx x&xxxx;xxxxxx xxxxxxxx 12&xxxx;% |
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Xxxxxxxxx: xxxxxxxxxx doplňkové látky. Xxxxxxx xxxxxxx: barviva: xx)&xxxx;xxxxx, xxxxx xxx xxxxxxxxx zvířaty xxxxxxxx xxxxx potravinám xxxxxxxxxxx xxxxxx |
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2x161&xxxx;x |
Xxxxxxxxxxxxx |
Xxxxxxx xxxxxxxxx xxxxx Xxxxxxxxxxxxx Xxxxxxxxxxxxxx-xxxx (XXXX) ≤ 100 mg/kg Dichlormethan ≤&xxxx;600&xxxx;xx/xx Xxxxxxxxxxxxxxx xxxxxx látky
Xxxxxxx: Xxxxx: xxxxxxxxx 96&xxxx;% Xxxxxxxxxxx xxxx xxx xxxxxxxxxxxxx: xx xxxx xxx 5&xxxx;% celkového xxxxxxxx xxxxxx. Xxxxxxxxxx xxxxxx (1) Xxx xxxxxxxxxxxx xxxxxxxxxxxxxx x&xxxx;xxxxxxxxx xxxxx: xxxxxxxxxxxxxxxxx xxx 426&xxxx;xx. Xxx xxxxxxxxxxxx xxxxxxxxxxxxxx v premixech x&xxxx;xxxxxxxx: xxxxxxxxxxxx kapalinová chromatografie xx xxxxxxxx xxxx x&xxxx;XXX xxxxxxxxxx (NP-HPLC-VIS, 466&xxxx;xx). |
Xxxxx xxxxx x&xxxx;xxxxx xxxxxxxxxxx xxxxx xxxxxxx |
– |
– |
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 mg xxxxxxxxxxxxxx/xx xxxxxxx (xxxxx xxxx) |
23.9.2025 |
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Xxxxxxx x&xxxx;xxxxxx xxxxxxx |
– |
– |
8 |
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2x161xx |
Xxxxxxxxxxxxx |
Xxxxxxx doplňkové xxxxx Přípravek xxxxxxxxxx xxxxxxx 10&xxxx;% kanthaxanthinu Dichlormethan ≤&xxxx;80&xxxx;xx/xx Xxxxxxxxxxxxxxx účinné látky
– Xxxxxxx: Xxxxx: nejméně 96&xxxx;% xxxxxxxxx xxxxxxxx xxxxxx (xxxxxxxxx jako kanthaxanthin) Karotenoidy xxxx xxx kanthaxanthin: ne xxxx xxx 5&xxxx;% xxxxxxxxx xxxxxxxx xxxxxx. Xxxxxxxxxx xxxxxx (1) Xxx kvantifikaci xxxxxxxxxxxxxx x&xxxx;xxxxxxxxx xxxxx: xxxxxxxxxxxxxxxxx xxx 426&xxxx;xx. Xxx xxxxxxxxxxxx kanthaxanthinu x&xxxx;xxxxxxxxx x&xxxx;xxxxxxxx: xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxx xx xxxxxxxx xxxx x&xxxx;XXX xxxxxxxxxx (XX-XXXX-XXX, 466&xxxx;xx). |
Xxxxx xxxxx x&xxxx;xxxxx menšinových xxxxx xxxxxxx |
– |
– |
25 |
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Xxxxxx 15&xxxx;xx xxxxxxxxxxxxxx/xx xxxxx (xxxxx xxxx) x&xxxx;2,5&xxxx;xx kanthaxanthinu/kg xxxx/xxxx (xxxxx tkáň) Nosnice 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, chemický xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx kategorie xxxxxx |
Xxxxxxxxx stáří |
Minimální xxxxx |
Xxxxxxxxx xxxxx |
Xxxx xxxxxxxxxx |
Xxxxxxxxx limity xxxxxxx |
Xxxxx xxxxxxxxx xxxxxxxx |
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xx xxxxxx látky / xx xxxxxxxxxxx xxxxxx x&xxxx;xxxxxx vlhkosti 12&xxxx;% |
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Xxxxxxxxx: xxxxxxxxxx doplňkové látky. Xxxxxxx xxxxxxx: xxxxxxx: xxx)&xxxx;xxxxx, xxxxx xxxx xxxxxxxxx vliv na xxxxxxxx okrasných ryb xxxx xxxxx |
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2x161&xxxx;x |
Xxxxxxxxxxxxx |
Xxxxxxx xxxxxxxxx xxxxx Xxxxxxxxxxxxx Xxxxxxxxxxxxxx-xxxx (XXXX) ≤&xxxx;100&xxxx;xx/xx Xxxxxxxxxxxxx ≤&xxxx;600&xxxx;xx/xx Xxxxxxxxxxxxxxx xxxxxx xxxxx
– Xxxxxxx: Xxxxx: minimálně 96&xxxx;% Xxxxxxxxxxx xxxx xxx kanthaxanthin: ne xxxx než 5&xxxx;% xxxxxxxxx množství xxxxxx. Xxxxxxxxxx xxxxxx (2) Pro xxxxxxxxxxxx xxxxxxxxxxxxxx x&xxxx;xxxxxxxxx xxxxx: xxxxxxxxxxxxxxxxx při 426&xxxx;xx. Xxx xxxxxxxxxxxx xxxxxxxxxxxxxx x&xxxx;xxxxxxxxx x&xxxx;xxxxxxxx: xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxx na xxxxxxxx xxxx x&xxxx;XXX xxxxxxxxxx (XX-XXXX-XXX, 466 nm). |
Okrasné xxxx a okrasní ptáci xxxxx xxxxxxxxx xxxxxxxxxx xxxxxx. |
– |
– |
100 |
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23.9.2025 |
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Xxxxxxx plemenné xxxxxxx |
– |
– |
8 |
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2x161xx |
Xxxxxxxxxxxxx |
Xxxxxxx xxxxxxxxx látky Xxxxxxxxx xxxxxxxxxx nejméně 10&xxxx;% xxxxxxxxxxxxxx Xxxxxxxxxxxxx ≤&xxxx;80&xxxx;xx/xx Xxxxxxxxxxxxxxx xxxxxx xxxxx
– Čistota: Obsah: xxxxxxx 96&xxxx;% xxxxxxxxx xxxxxxxx xxxxxx (xxxxxxxxx xxxx xxxxxxxxxxxxx) Xxxxxxxxxxx jiné xxx xxxxxxxxxxxxx: xx více xxx 5&xxxx;% xxxxxxxxx množství xxxxxx. Xxxxxxxxxx metoda (2) Xxx xxxxxxxxxxxx kanthaxanthinu x&xxxx;xxxxxxxxx látce: xxxxxxxxxxxxxxxxx xxx 426&xxxx;xx. Xxx kvantifikaci xxxxxxxxxxxxxx x&xxxx;xxxxxxxxx x&xxxx;xxxxxxxx: xxxxxxxxxxxx xxxxxxxxxx chromatografie xx normální xxxx x&xxxx;XXX xxxxxxxxxx (XX-XXXX-XXX, 466&xxxx;xx). |
Xxxxxxx xxxx x&xxxx;xxxxxxx xxxxx kromě okrasných xxxxxxxxxx nosnic. |
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– |
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 metodách lze 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.
(2)&xxxx;&xxxx;Xxxxxxxx informace x&xxxx;xxxxxxxxxxxx xxxxxxxx xxx xxxxxx xx internetové xxxxxxx xxxxxxxxxx xxxxxxxxxx: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en.