XXXXXXXXX XXXXXXXX XXXXXX (XX) 2022/1420
ze xxx 22.&xxxx;xxxxx 2022
x&xxxx;xxxxxxxx X-xxxxxxxxx xxxxxxxx x&xxxx;xxxxxxxxx xxxxxxx x&xxxx;Xxxxxxxxxxxxxxx glutamicum XXXX XX-01681&xxxx;xxxx xxxxxxxxxxx xxxxx xxx xxxxxxx druhy xxxxxx
(Xxxx s významem xxx XXX)
XXXXXXXX XXXXXX,
x&xxxx;xxxxxxx na Xxxxxxx x&xxxx;xxxxxxxxx Xxxxxxxx xxxx,
x&xxxx;xxxxxxx xx nařízení Xxxxxxxxxx xxxxxxxxxx a Rady (XX) x.&xxxx;1831/2003 xx xxx 22.&xxxx;xxxx&xxxx;2003 o doplňkových xxxxxxx xxxxxxxxxxx ve xxxxxx xxxxxx&xxxx;(1), x&xxxx;xxxxxxx xx čl. 9 odst. 2 xxxxxxxxx xxxxxxxx,
xxxxxxxx k těmto xxxxxxx:
|
(1) |
Xxxxxxxx (XX) x.&xxxx;1831/2003 xxxxxxx povolení xxxxxxxxxxx xxxxx xxxxxxxxxxx ve xxxxxx xxxxxx x&xxxx;xxxxxx x&xxxx;xxxxxxx, xx xxxxxxx xxxxxxx se xxxxxxxx xxxxxxx. |
|
(2) |
X&xxxx;xxxxxxx x&xxxx;xxxxxxx&xxxx;7 xxxxxxxx (XX) x.&xxxx;1831/2003 byla xxxxxx žádost x&xxxx;xxxxxxxx X-xxxxxxxxx kyseliny a glutamanu xxxxxxx x&xxxx;Xxxxxxxxxxxxxxx glutamicum XXXX XX-01681. Tato xxxxxx xxxx xxxxxx xxxxx x&xxxx;xxxxx x&xxxx;xxxxxxxxx xxxxxxxxxxxx xxxxx xx.&xxxx;7 xxxx.&xxxx;3 nařízení (ES) x.&xxxx;1831/2003. |
|
(3) |
Xxxxxx xx xxxx xxxxxxxx L-glutamové kyseliny x&xxxx;xxxxxxxxx sodného x&xxxx;Xxxxxxxxxxxxxxx xxxxxxxxxx NITE XX-01681&xxxx;xxxx xxxxxxxxxxx xxxxx xxx xxxxxxx xxxxx zvířat xx xxxxxxxxx do xxxxxxxxx „xxxxxxxx xxxxxxxxx xxxxx“ x&xxxx;„xxxxxxxxxx xxxxxxxxx xxxxx“. |
|
(4) |
Xxxxxxx požádal x&xxxx;xxxxxxxx xxxxxxx xxxxxxxxx xxxxx xxx použití xxxxxx xx vodě x&xxxx;xxxxxxxx. Xxxxxxxx (ES) č. 1831/2003 xxxx xxxxxxxxxx xxxxxxx „xxxxxxxxxxx xxxxx“ xxx xxxxxxx xx vodě x&xxxx;xxxxxxxx. Xxxxxxx xxxxxxxxx xxxxxxx x&xxxx;Xxxxxxxxxxxxxxx xxxxxxxxxx XXXX 80188 xx xxxx x&xxxx;xxxxxxxx xx xxxxx xxxxxx xxx xxxxxxxx. Xxxxxxxxxx, xx xxxxxxx xxxxxxx xxxxxxxxx xxxxx xxxx xxxxxxxxxxx xxxxx se xxxxxxxxxx xx xxxx x&xxxx;xxxxxxxx, xxxxxxx xxxxxx xxxxxxx x&xxxx;xxxxxxx xxxxxxx xxxxxxxxxx x&xxxx;xxxxx. |
|
(5) |
Xxxxxxxx xxxx xxx xxxxxxxxxx potravin (dále xxx „úřad“) xxxxxx xx xxxx stanovisku xx xxx 26.&xxxx;xxxxx&xxxx;2022&xxxx;(2) x&xxxx;xxxxxx, že xx xxxxxxxxxxxx xxxxxxxx xxxxxxx xxxx L-glutamová xxxxxxxx x&xxxx;xxxxxxxx xxxxx z Corynebacterium xxxxxxxxxx NITE BP-01681 xxxxxxxxxx účinky xx xxxxxx zvířat, xxxxxxxxxx xxxxxxxxxxxx nebo na xxxxxxx xxxxxxxxx. Xxxx xxxxxx dospěl k závěru, xx tyto xxxxx xxxxxx xxxxxxxxxx xx xxxxxxxx xxx xxxx xxxx oči xxx xx senzibilizátory xxxx, xxx jsou považovány xx xxxxxx při xxxxxxxxx. Xxxxxx xx xxxxx domnívá, xx xx xxxx být xxxxxxx xxxxxx ochranná xxxxxxxx, xxx xx xxxxxxxxx xxxxxxxxxxx xxxxxxx xx xxxxxx xxxxxx, xxxxxxx xxxxx xxx x&xxxx;xxxxxxxxx xxxx xxxxxxxxx xxxxx. Úřad rovněž xxxxxx x&xxxx;xxxxxx, že xxxx xxxxx xxxxx xxx xxxxxx xxxx xxxxxxxx xxxxxxxxx xxxxx x&xxxx;xxxx xxxxxxxxxxx xxxxx x&xxxx;xxxxxxxx. Xxxx xxxxxxxx xxxxxxxxx na xxxxxxxxxxxx xx xxxxxxx xx xxx xxxxxxxxxx xx xxxxx. Xxxx xxxx xxxxxx xxxxxx o metodách xxxxxxx xxxxxxxxx xxxxx xxxxxxx do krmiv xxxxxxxxxxx referenční laboratoří, xxxxxxxx xxxxxxxxx (XX) x.&xxxx;1831/2003. |
|
(6) |
Xxxxxxxxx X-xxxxxxxxx xxxxxxxx x&xxxx;xxxxxxxxx xxxxxxx z Corynebacterium xxxxxxxxxx XXXX XX-01681 xxxxxxxxx, xx podmínky xxx xxxxxxxx xxxxxxxxx x&xxxx;xxxxxx&xxxx;5 xxxxxxxx (ES) x.&xxxx;1831/2003 jsou xxxxxxx. Xxxxx xx používání xxxxxxxxx xxxxx mělo xxx xxxxxxxx podle xxxxxxx xxxxxx xxxxxxxx. |
|
(7) |
X&xxxx;xxxxx xxxxx xxxxxxxx xx xxxx xxx xxxxxxxxx xxxxxx podmínky a omezení. Xx xxxxxxx doplňkové xxxxx by xxx xxx xxxxxxx xxxxxx xxxxxxxxxx xxxxx. Pokud xx doporučený obsah xxxxxxxxx, xxxx xx xxx na etiketě xxxxxxx uvedeny xxxxxx xxxxxxxxx. |
|
(8) |
Xxxxxxxx stanovená tímto xxxxxxxxx jsou v souladu xx stanoviskem Stálého xxxxxx xxx rostliny, xxxxxxx, xxxxxxxxx a krmiva, |
PŘIJALA XXXX XXXXXXXX:
Xxxxxx&xxxx;1
1.&xxxx;&xxxx;&xxxx;Xxxxx uvedené x&xxxx;xxxxxxx, xxxxxxxxxx do xxxxxxxxx xxxxxxxxxxx xxxxx „xxxxxxxx xxxxxxxxx xxxxx“ a funkční xxxxxxx „xxxxxxxxxxxxx, xxxxxx xxxx x&xxxx;xxxxxxx“, se xxxxxxxx xxxx xxxxxxxxx xxxxx xx xxxxxx xxxxxx podle xxxxxxxx xxxxxxxxxxx v uvedené xxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxx xxxxxxx x&xxxx;xxxxxxx, xxxxxxxxxx xx xxxxxxxxx xxxxxxxxxxx xxxxx „xxxxxxxxxx doplňkové xxxxx“ x&xxxx;xxxxxxx skupiny „xxxxxxxxxxx xxxxx“, xx xxxxxxxx xxxx doplňkové xxxxx xx xxxxxx xxxxxx xxxxx xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxx.
Xxxxxx&xxxx;2
Xxxx xxxxxxxx vstupuje x&xxxx;xxxxxxxx dvacátým xxxx xx xxxxxxxxx x&xxxx;Xxxxxxx xxxxxxxx Xxxxxxxx unie.
Xxxx xxxxxxxx xx xxxxxxx x&xxxx;xxxxx xxxxxxx x&xxxx;xxxxx xxxxxxxxxx ve xxxxx xxxxxxxxx státech.
V Bruselu xxx 22. srpna 2022.
Xx Xxxxxx
xxxxxxxxxxx
Xxxxxx VON XXX XXXXX
(1)&xxxx;&xxxx;Xx.&xxxx;xxxx.&xxxx;X&xxxx;268, 18.10.2003, x.&xxxx;29.
(2)&xxxx;&xxxx;XXXX Xxxxxxx 2022;20(3):7156.
XXXXXXX
|
Xxxxxxxxxxxxx xxxxx xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, chemický xxxxxx, popis, xxxxxxxxxx xxxxxx |
Xxxx xxxx kategorie xxxxxx |
Xxxxxxxxx stáří |
Minimální xxxxx |
Xxxxxxxxx xxxxx |
Xxxx xxxxxxxxxx |
Xxxxx platnosti xxxxxxxx |
||||||||||||||||||||
|
xx xxxxxx xxxxx/xx xxxxxxxxxxx xxxxxx x&xxxx;xxxxxx xxxxxxxx 12 % |
||||||||||||||||||||||||||||
|
Kategorie: nutriční xxxxxxxxx látky. Funkční xxxxxxx: xxxxxxxxxxxxx, xxxxxx xxxx x&xxxx;xxxxxxx. |
||||||||||||||||||||||||||||
|
2x620x |
X-xxxxxxxxx kyselina |
Složení xxxxxxxxx xxxxx X-xxxxxxxxx xxxxxxxx Xxxxxxxxxxxxxxx xxxxxx xxxxx X-xxxxxxxxx xxxxxxxx z Corynebacterium xxxxxxxxxx XXXX XX-01681 Xxxxxxx: ≥&xxxx;98&xxxx;% Xxxxxxxx xxxxxx: X5X9X4X Xxxxx XXX: 56-86-0 Číslo XXXXXX: 200-293-7 Xxxxxxxxxx xxxxxx (1) Xxx xxxxxxxxxxxx X-xxxxxxxxx kyseliny x&xxxx;xxxxxxxxx látce:
Xxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxx x&xxxx;xxxxxxxxx látce:
Pro kvantifikaci xxxxxxxxx kyseliny x&xxxx;xxxxxxxxx:
Xxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxx x&xxxx;xxxxxxxx:
|
Xxxxxxx xxxxx xxxxxx |
– |
– |
– |
|
12.&xxxx;xxxx 2032 |
||||||||||||||||||||
|
Xxxxxxxxxxxxx xxxxx doplňkové xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, xxxxxxxx xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx kategorie xxxxxx |
Xxxxxxxxx stáří |
Minimální xxxxx |
Xxxxxxxxx xxxxx |
Xxxx xxxxxxxxxx |
Xxxxx xxxxxxxxx xxxxxxxx |
||||||||||||||||||||
|
xx účinné látky/kg xxxxxxxxxxx krmiva o obsahu xxxxxxxx 12&xxxx;% |
||||||||||||||||||||||||||||
|
Xxxxxxxxx: xxxxxxxxxx xxxxxxxxx xxxxx. Xxxxxxx skupina: xxxxxxxxxxx látky. |
||||||||||||||||||||||||||||
|
2b620i |
L-glutamová xxxxxxxx |
Xxxxxxx xxxxxxxxx xxxxx X-xxxxxxxxx xxxxxxxx Xxxxxxxxxxxxxxx xxxxxx látky L-glutamová kyselina x&xxxx;Xxxxxxxxxxxxxxx glutamicum XXXX XX-01681 Xxxxxxx: ≥ 98 % Chemický xxxxxx: X5X9X4X Xxxxx XXX: 56-86-0 Xxxxx XXXXXX: 200-293-7 Analytická xxxxxx (2) Xxx xxxxxxxxxxxx X-xxxxxxxxx xxxxxxxx v doplňkové xxxxx:
Xxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxx x&xxxx;xxxxxxxxx látce:
Xxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxx x&xxxx;xxxxxxxxx:
|
Xxxxxxx xxxxx xxxxxx |
– |
– |
– |
|
12. září 2032 |
||||||||||||||||||||
|
Xxxxxxxxxxxxx číslo xxxxxxxxx xxxxx |
Xxxxxxxxx látka |
Složení, xxxxxxxx xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx nebo xxxxxxxxx xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx obsah |
Maximální xxxxx |
Xxxx ustanovení |
Konec xxxxxxxxx xxxxxxxx |
||||||||||||||||||||
|
xx xxxxxx xxxxx/xx xxxxxxxxxxx xxxxxx x&xxxx;xxxxxx xxxxxxxx 12&xxxx;% |
||||||||||||||||||||||||||||
|
Xxxxxxxxx: xxxxxxxx xxxxxxxxx xxxxx. Xxxxxxx skupina: xxxxxxxxxxxxx, jejich soli x&xxxx;xxxxxxx. |
||||||||||||||||||||||||||||
|
2x621xx |
Xxxxxxxx xxxxx |
Xxxxxxx xxxxxxxxx xxxxx Xxxxxxxx xxxxx Xxxxxxxxxxxxxxx účinné xxxxx Xxxxxxxx xxxxx x&xxxx;Xxxxxxxxxxxxxxx xxxxxxxxxx XXXX XX-01681 Xxxxxxx: ≥&xxxx;99&xxxx;% Xxxxxxxx xxxxxx: X5X8XxXX4·X2X Xxxxx XXX: 6106-04-3 Xxxxx XXXXXX: 205-538-1 Xxxxxxxxxx xxxxxx (3) Pro xxxxxxxxxxxx monohydrátu X-xxxxxxxxx xxxxxxx v doplňkové látce:
Xxx xxxxxxxxxxxx glutamanu xxxxxxx x&xxxx;xxxxxxxxx xxxxx:
Xxx xxxxxxxxxxxx glutamanu xxxxxxx x&xxxx;xxxxxxxxx:
Xxx xxxxxxxxxxxx xxxxxxxxx xxxxxxx x&xxxx;xxxxxxxx:
|
Xxxxxxx xxxxx zvířat |
– |
– |
– |
|
12.&xxxx;xxxx 2032 |
||||||||||||||||||||
|
Identifikační xxxxx xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, xxxxxxxx xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx xxxxxxxxx xxxxxx |
Xxxxxxxxx stáří |
Minimální xxxxx |
Xxxxxxxxx xxxxx |
Xxxx xxxxxxxxxx |
Xxxxx xxxxxxxxx povolení |
||||||||||||||||||||
|
mg xxxxxx xxxxx/xx xxxxxxxxxxx krmiva x&xxxx;xxxxxx xxxxxxxx 12 % |
||||||||||||||||||||||||||||
|
Kategorie: xxxxxxxxxx doplňkové látky. Funkční xxxxxxx: xxxxxxxxxxx xxxxx. |
||||||||||||||||||||||||||||
|
2x621xx |
Xxxxxxxx xxxxx |
Xxxxxxx xxxxxxxxx xxxxx Xxxxxxxx xxxxx Xxxxxxxxxxxxxxx xxxxxx xxxxx Xxxxxxxx xxxxx x&xxxx;Xxxxxxxxxxxxxxx xxxxxxxxxx XXXX XX-01681 Xxxxxxx: ≥&xxxx;99&xxxx;% Xxxxxxxx xxxxxx: X5X8XxXX4·X2X Xxxxx XXX: 6106-04-3 Xxxxx XXXXXX: 205-538-1 Xxxxxxxxxx xxxxxx (4) Pro identifikaci xxxxxxxxxxx X-xxxxxxxxx xxxxxxx x&xxxx;xxxxxxxxx xxxxx:
Xxx xxxxxxxxxxxx glutamanu xxxxxxx x&xxxx;xxxxxxxxx látce:
Xxx xxxxxxxxxxxx xxxxxxxxx xxxxxxx x&xxxx;xxxxxxxxx:
|
Xxxxxxx xxxxx xxxxxx |
– |
– |
– |
|
12.&xxxx;xxxx 2032 |
||||||||||||||||||||
(1)&xxxx;&xxxx;Xxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxxxxx xxxxxxxx xxx xxxxxx xx xxxxxxxxxxx xxxxxxx referenční xxxxxxxxxx: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
(2) Podrobné informace 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
(3)&xxxx;&xxxx;Xxxxxxxx informace x&xxxx;xxxxxxxxxxxx xxxxxxxx xxx získat xx xxxxxxxxxxx stránce xxxxxxxxxx xxxxxxxxxx: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
(4) Podrobné xxxxxxxxx x&xxxx;xxxxxxxxxxxx xxxxxxxx xxx xxxxxx na xxxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxxxxxxx: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en