XXXXXXXXX XXXXXXXX XXXXXX (XX) 2021/2047
xx dne 23.&xxxx;xxxxxxxxx 2021
x&xxxx;xxxxxxxx amprolia xxxxxxxxxxxxx (COXAM) xxxx xxxxxxxxx xxxxx xxx xxxxx xxxxx x&xxxx;xxxxxx xxxxx x&xxxx;xxxxxx (xxxxxxx xxxxxxxx: XxxxXxxxxx XX)
(Xxxx x&xxxx;xxxxxxxx pro XXX)
XXXXXXXX XXXXXX,
x&xxxx;xxxxxxx na Smlouvu x&xxxx;xxxxxxxxx Xxxxxxxx xxxx,
x&xxxx;xxxxxxx xx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;1831/2003 xx xxx 22.&xxxx;xxxx&xxxx;2003 x&xxxx;xxxxxxxxxxx xxxxxxx xxxxxxxxxxx ve výživě xxxxxx&xxxx;(1), x&xxxx;xxxxxxx xx xx.&xxxx;9 xxxx.&xxxx;2 xxxxxxxxx xxxxxxxx,
xxxxxxxx x&xxxx;xxxxx xxxxxxx:
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(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 xxxxxxxx uděluje. |
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(2) |
V souladu x&xxxx;xxxxxxx&xxxx;7 xxxxxxxx (XX) x.&xxxx;1831/2003 xxxx podána xxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxxxxxxxxxxx (XXXXX). Xxxxxxx xxxxxx xxxx podána xxxxx x&xxxx;xxxxx x&xxxx;xxxxxxxxx xxxxxxxxxxxx xxxxx xx.&xxxx;7 xxxx.&xxxx;3 xxxxxxxxx nařízení. |
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(3) |
Žádost xx xxxx povolení xxxxxxxx xxxxxxxxxxxxx (COXAM) xxxx doplňkové xxxxx xxx xxxxx xxxxx x&xxxx;xxxxxx xxxxx x&xxxx;xxxxxx xx xxxxxxxxx do xxxxxxxxx xxxxxxxxxxx xxxxx „xxxxxxxxxxxxxxx a histomonostatika“. |
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(4) |
Evropský xxxx xxx bezpečnost xxxxxxxx (xxxx xxx „úřad“) xxxxxx ve svých xxxxxxxxxxxx xx xxx 13.&xxxx;xxxxxx&xxxx;2018&xxxx;(2) x&xxxx;27.&xxxx;xxxxx&xxxx;2021&xxxx;(3) k závěru, xx xx xxxxxxxxxx xxxxxxxx xxxxx xxxx xxxxxxxxx hydrochlorid (XXXXX) xxxxxxxxxx účinek xx xxxxxx xxxxxx xxx xx životní xxxxxxxxx. Xxxxxx xxxxxx x&xxxx;xxxxxx, xx xx xxxxxxx xxxxxxxxx látka měla xxx považována xx xxxxx, xxxxx xxxx xxxxxxxxxxxxxx xxxxxxx cesty x&xxxx;xxxx. Komise xx xxxxx xxxxxxx, xx xx xxxx xxx xxxxxxx xxxxxx ochranná xxxxxxxx, xxx xx xxxxxxxxx xxxxxxxxxxx účinkům xx xxxxxx zdraví, xxxxxxx xxxxx xxx x&xxxx;xxxxxxxxx xxxxxxx doplňkové xxxxx. Úřad xxxxxx xxxxxx k závěru, že xxxxxxxx k nedostatku xxxxxxxxxxxx xxxxx xxxxxx xxxxxxxxx xxxxxxxxxx xxxxxxx xxxxx xxxxxxxxxx xxx xxxxxxxxx xxxxxx, x&xxxx;xxxxx není xxxxxxx xxxxxx x&xxxx;xxxxxx x&xxxx;xxxxxxxxxxx xxxxxxx doplňkové xxxxx pro spotřebitele. Xxxx xxxx xxxxxx x&xxxx;xxxxxx, že xxxxxxx xxxxxxxxx látka xx xxxxxx xxx xxxxxxx xxxxxxxxxx x&xxxx;xxxxxx kuřat x&xxxx;xx xxxxx xxxxx xxx xxxxxxxx x&xxxx;xx xxxxxx kuřat a kuřice. Xxxxxx xxxxxx x&xxxx;xxxxxx, xx xx měl xxx xxxxxxxx xxxx xxxxxxxxxxxx xx xxxxxxx xx xxx xxxxxxxx xx xxxxxxxxx vůči Xxxxxxx spp. Úřad xxxx xxxxxx xxxxxx x&xxxx;xxxxxx analýzy xxxxxxxxx xxxxx xxxxxxx xx xxxxx, xxxxxx předložila xxxxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxx (ES) x.&xxxx;1831/2003. |
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(5) |
Xxxxxxxxx xxxxxxxxxxxx xxx byl xxxxxxxx Xxxxxxx pro xxxxxxxxxxx xxxxxx xxxxxxxxx Xxxxxxxx agentury xxx xxxxxx xxxxxxxxx (xxxx xxx „EMA XXXX“). Xx své xxxxxx x&xxxx;xxxxx 2001&xxxx;(4) xxxxxx xxxxx XXX XXXX x&xxxx;xxxxxx, xx pro xxxxxxxxx není xxxxx xxxxxxxx xxxxxxxxx xxxxx xxxxxxx (MLR). Amprolium xxx xxxxxx xx xxxxx xxxxxxx x&xxxx;xxxxxxx 1 xxxxxxx xxxxxxxx Xxxxxx (XX) x.&xxxx;37/2010&xxxx;(5). X&xxxx;xxxxxx xxxxxx xxxx xxxxxxxxxx amprolia xxxxxxxxxxxxx xxx xxxxxxxxxxxx dostatečně xxxxxxxxx x&xxxx;xxxxxxx s čl. 8 xxxx.&xxxx;4 xxxx. x) xxxxxxxx (XX) x.&xxxx;1831/2003. |
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(6) |
Xxxxxxxxx xxxxxxxx xxxxxxxxxxxxx (COXAM) xxxxxxxxx, že podmínky xxx povolení xxxxxxxxx x&xxxx;xxxxxx&xxxx;5 xxxxxxxx (XX) x.&xxxx;1831/2003 xxxx splněny. Xxxxxxxxx xxxxxxx xxxxx xx xxxxx mělo xxx xxxxxxxx. |
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(7) |
Xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxx x&xxxx;xxxxxxx se xxxxxxxxxxx Xxxxxxx xxxxxx xxx xxxxxxxx, xxxxxxx, xxxxxxxxx x&xxxx;xxxxxx, |
XXXXXXX XXXX XXXXXXXX:
Článek 1
Povolení
Látka xxxxxxx x&xxxx;xxxxxxx, xxxxxxxxxx xx xxxxxxxxx xxxxxxxxxxx xxxxx „kokcidiostatika x&xxxx;xxxxxxxxxxxxxxxx“, se povoluje xxxx xxxxxxxxx xxxxx xx xxxxxx xxxxxx xxxxx xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxx.
Xxxxxx&xxxx;2
Xxxxx v platnost
Toto xxxxxxxx xxxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx xx xxxxxxxxx x&xxxx;Xxxxxxx xxxxxxxx Xxxxxxxx xxxx.
Toto xxxxxxxx xx xxxxxxx x&xxxx;xxxxx rozsahu x&xxxx;xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx státech.
V Bruselu xxx 23.&xxxx;xxxxxxxxx 2021.
Xx Xxxxxx
xxxxxxxxxxx
Xxxxxx XXX XXX XXXXX
(1)&xxxx;&xxxx;Xx. věst. L 268, 18.10.2003, x.&xxxx;29.
(2)&xxxx;&xxxx;XXXX Xxxxxxx 2018;16(7):5338.
(3)&xxxx;&xxxx;XXXX Xxxxxxx 2021;19(3):6457.
(4)&xxxx;&xxxx;XXX XXXX (Výbor xxx xxxxxxxxxxx xxxxxx xxxxxxxxx Xxxxxxxx xxxxxxxx xxx xxxxxx xxxxxxxxx), 2001. Xxxxxxxxx Xxxxxxx Xxxxxx (2). EMEA/MRL/767/00-FINAL, leden 2001. xxxxx://xxx.xxx.xxxxxx.xx/xx/xxxxxxxxx/xxx-xxxxxx/xxxxxxxxx-xxxxxxx-xxxxxx-2-xxxxxxxxx-xxxxxxxxxx-xxxxxxxxx-xxxxxxxx_xx.xxx
(5)&xxxx;&xxxx;Xxxxxxxx Komise (EU) x.&xxxx;37/2010 xx dne 22.&xxxx;xxxxxxxx&xxxx;2009 o farmakologicky účinných xxxxxxx a jejich klasifikaci xxxxx xxxxxxxxxxx limitů xxxxxxx v potravinách xxxxxxxxxxx xxxxxx (Úř. xxxx. X&xxxx;15, 20.1.2010, s. 1).
XXXXXXX
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Xxxxxxxxxxxxx xxxxx xxxxxxxxx xxxxx |
Xxxxx držitele xxxxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, xxxxxxxx xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx xxxxxxxxx xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx obsah |
Maximální xxxxx |
Xxxx xxxxxxxxxx |
Xxxxx xxxxxxxxx xxxxxxxx |
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xx xxxxxx xxxxx/xx xxxxxxxxxxx xxxxxx x&xxxx;xxxxxx xxxxxxxx 12&xxxx;% |
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Xxxxxxxxx xxxxxxxxx xxxxx: xxxxxxxxxxxxxxx x&xxxx;xxxxxxxxxxxxxxxx. |
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51777 |
XxxxXxxxxx NV |
Amprolium xxxxxxxxxxxx (XXXXX) |
Xxxxxxx doplňkové látky Xxxxxxxxx HCl: 250&xxxx;x/xx Xxxxxxx xxxxxxx: 30&xxxx;x/xx Xxxxxx xxxxxx xx 1 000 g. Charakteristika xxxxxx látky Xxxxxxxxx xxxxxxxxxxxx (čistota > 97,5 %) C14H19ClN4.HCl, (1-[(4-amino-2-propyl-5-pyrimidinyl)methyl]-2-methylpyridinium xxxxxxx xxxxxxxxxxxxxxxx, xxxxx XXX: 137-88-2. Xxxxxxxxxx xxxxxxxxx: α-xxxxxxx &xx;&xxxx;0,52&xxxx;%, xxxxxxxxx xxxxx ≤&xxxx;0,1&xxxx;% Xxxxxxxxxx metoda &xxxx;(1) Xxx xxxxxxxxx xxxxxxxx v doplňkové xxxxx:
Xxx kvantifikaci xxxxxxxx x&xxxx;xxxxxxxxx a krmivech:
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Xxxxx xxxxx Xxxxxx xxxxx |
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14.12.2031 |
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(1)&xxxx;&xxxx;Xxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxxxxx xxxxxxxx xxx získat xx internetové xxxxxxx xxxxxxxxxx xxxxxxxxxx:xxxxx://xx.xxxxxx.xx/xxx/xx/xxxx/xxxx-xxxxxxxxx/xxxxxxxxxx-xxxxxxx