XXXXXXXXX NAŘÍZENÍ XXXXXX (XX) 2021/912
xx xxx 4.&xxxx;xxxxxx 2021,
kterým se xxxxxxxx xxxxx xxxxxxxxxxx xxxx xxxxxxxxx xxxxx-X-xxxxxxxxxxx (xxxxxxxxxxx zdroj) x&xxxx;xxxxxx xx xxxx xxxxxxxxx xxxxxxxx (EU) 2017/2470
(Text x&xxxx;xxxxxxxx xxx EHP)
EVROPSKÁ XXXXXX,
x&xxxx;xxxxxxx xx Xxxxxxx x&xxxx;xxxxxxxxx Evropské xxxx,
x&xxxx;xxxxxxx xx xxxxxxxx Evropského xxxxxxxxxx x&xxxx;Xxxx (EU) 2015/2283 xx xxx 25.&xxxx;xxxxxxxxx&xxxx;2015 x&xxxx;xxxxxx xxxxxxxxxxx, x&xxxx;xxxxx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx a Rady (XX) x.&xxxx;1169/2011 x&xxxx;x&xxxx;xxxxxxx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;258/97 x&xxxx;xxxxxxxx Xxxxxx (ES) x.&xxxx;1852/2001&xxxx;(1), x&xxxx;xxxxxxx xx článek 12 xxxxxxxxx nařízení,
vzhledem x&xxxx;xxxxx xxxxxxx:
|
(1) |
Xxxxxxxx (XX) 2015/2283 xxxxxxx, xx xx xxx v Unii xxxxx xxx xxxxxxx xxxxx xxxx xxxxxxxxx xxxxxxxx x&xxxx;xxxxxxxx na seznam Xxxx. |
|
(2) |
Xxxxx xxxxxx&xxxx;8 xxxxxxxx (XX) 2015/2283 bylo xxxxxxx xxxxxxxxx xxxxxxxx Xxxxxx (EU) 2017/2470&xxxx;(2), xxxxxx xx xxxxxxx xxxxxx Xxxx xxx xxxxxxxx xxxx xxxxxxxxx. |
|
(3) |
Xxxxx xxxxxx&xxxx;12 xxxxxxxx (XX) 2015/2283 Xxxxxx xxxxxxxxx xxxxx xxxxxxxxxxx xxxx, xxxxxx xx xxxxxxxx xxxxxxx xxxx xxxxxxxxx xx xxx x&xxxx;Xxxx x&xxxx;xxxxxx se xxxxxxxxxxx xxxxxx Xxxx. |
|
(4) |
Xxxxxxxxxx xxxxxxxxxxx Xxxxxx (XX) 2016/375 (3) xx v souladu x&xxxx;xxxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) č. 258/97 (4) povolilo xxxxxxx chemicky syntetizované xxxxx-X-xxxxxxxxxxx xx xxx xxxx xxxx xxxxxx xxxxxxxx. |
|
(5) |
Xxxxx xxxxxx&xxxx;5 xxxxxxxx (XX) x.&xxxx;258/97 xxxxxxxxxxx xxxxxxxxxx Xxxxxx A/S dne 1.&xxxx;xxxx&xxxx;2016 Komisi x&xxxx;xxxx xxxxxx xxxxx xx xxx xxxx novou xxxxxx xxxxxxxx výrobek xxxxx-X-xxxxxxxxxxx x&xxxx;xxxxxxxxxxxxx xxxxxx xxxxxxxx x&xxxx;xxxxx Xxxxxxxxxxx xxxx X-12. |
|
(6) |
Xxxxxxxxxx Xxxxxx X/X&xxxx;x oznámení Komisi xxxx xxxxxxxxxx zprávu xxxxxxx příslušným xxxxxxx x&xxxx;Xxxxx podle xx.&xxxx;3 xxxx.&xxxx;4 xxxxxxxx (ES) x.&xxxx;258/97, xxxxx xx xxxxxxx xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxxxx společností xxxxxx x&xxxx;xxxxxx, xx xxxxx-X-xxxxxxxxxxx xxxxxxxx x&xxxx;xxxxx Xxxxxxxxxxx coli K-12 xx x&xxxx;xxxxxxxxx xxxx xxxxxxxxxx syntetické xxxxx-X-xxxxxxxxxxx xxxxxxxx xxxxxxxxxx rozhodnutím (XX) 2016/375. Xxxxx-X-xxxxxxxxxxx x&xxxx;xxxxxxxxxxxxx zdroje byla xxxxx přidána xx xxxxxx Unie xxx xxxx xxxxxxxxx. |
|
(7) |
Xxx 23.&xxxx;xxxxxx&xxxx;2019 xxxxxxxxxx xxxxxxxxxx Xxx. Xxxxxx X/X&xxxx;(xxxx xxx „xxxxxxx“) Komisi xxxxxx x&xxxx;xxxxxxx x&xxxx;xx.&xxxx;10 xxxx.&xxxx;1 xxxxxxxx (XX) 2015/2283 x&xxxx;xxxxxxxx lakto-N-neotetraosy (xxxxxxxxxxx xxxxx) vyráběné kombinovanou xxxxxxxxx xxxxxxxxxxxx xxxxx XX-XXxX-XXX x&xxxx;XX-XXxX-XXX xxxxx Xxxxxxxxxxx xxxx XX21(XX3) xxxx nové potraviny xx xxxxxxxx xxxxxxxx xxxxxxx, xxxx xxxx xxxx xxxxxxxx xxx xxxxx-X-xxxxxxxxxxx xx xxxxxxxxxxxx x&xxxx;xxxxxxxxxxxxx xxxxxx. Xxxxxxx xxxxxxx o aktualizaci seznamu Xxxx, xxxxx xxx x&xxxx;xxxx xxxxx této xxxx xxxxxxxxx. |
|
(8) |
Xxxxx xxxx xxxxxxx xxxxxx xxxxxxxxxxxx xxxxxxx specifikace xxxxx-X-xxxxxxxxxxx (xxxxxxxxxxx xxxxx) xxxxxxxx x&xxxx;xxxxxx nového xxxxxx, xxxxx xx liší xx xxxxxxxxxxx xxxxxxxx xxxxx-X-xxxxxxxxxxx z mikrobiologického zdroje xxxxxxxx z kmene Escherichia xxxx X-12, xxxxx xxx x&xxxx;xxxxxxx xxxxxx xxxxxx z ≤ 0,4 % na ≤&xxxx;1,0&xxxx;%, xxxxx úroveň xxx xxxxxxxxxx xxxxxxxx x&xxxx;xxxxxx xx stávajících ≤&xxxx;10 xxxxxxx xxxxxxxxx xxxxxxxx („KTJ“)/g nové xxxxxxxxx xxx xxxxx xxx xxxxxxxxxxxxxx xx ≤&xxxx;50 XXX/x xxx xxxxxxxxx obou a nepřítomnost xxxxxxxxx (xx současné xxxxxxx ≤ 100 mg/kg) a fruktosového xxxxxxx xxxxx-X-xxxxxxxxxxx (xx xxxxxxxx xxxxxxx ≤&xxxx;1,0&xxxx;%). |
|
(9) |
Xxx 17.&xxxx;xxxxx&xxxx;2020 xxxxxxxx Komise Xxxxxxxx xxxx pro xxxxxxxxxx xxxxxxxx (xxxx xxx „xxxx“), xxx xxxxxxx xxxxxxxxx xxxxx-X-xxxxxxxxxxx xxxxxxxx kombinovanou xxxxxxxxx xxxxxxxxxxxx xxxxx PS-LNnT-JBT x&xxxx;XX-XXxX-XXX xxxxx Xxxxxxxxxxx xxxx XX21(XX3) v souladu x&xxxx;xxxxxxxxx xxxxxx&xxxx;11 xxxxxxxx (XX) 2015/2283. |
|
(10) |
Xxx 22.&xxxx;xxxxx&xxxx;2020 xxxxxx úřad vědecké xxxxxxxxxx x&xxxx;xxxxxx „Xxxxxx xx xxxxx-X-xxxxxxxxxxx (LNnT) xxxxxxxx by xxxxxxxxxx xxxxxxx of X. xxxx BL21 as x&xxxx;xxxxx food xxxxxxxx xx Xxxxxxxxxx (XX) 2015/2283“&xxxx;(5). |
|
(11) |
Xx xxxx xxxxxxxx xxxxxxxxxx xxxx xxxxxx x&xxxx;xxxxxx, xx lakto-N-neotetraosa (XXxX) vyráběná xxxxxxxxxxxx xxxxxxxxx xxxxxxxxxxxx xxxxx XX-XXxX-XXX a DS-LNnT-JBT xxxxx Xxxxxxxxxxx coli XX21(XX3) xx xxxx xxxx xxxxxxxxx xxxxx xxxxxxxx (XX) 2015/2283 xx xxxxxxxxxxx povolených xxxxxxxx xxxxxxx xxxxxxxx. Uvedené xxxxxxx xxxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxxx xxxxxx xx xxxxxxxxx toho, xx lakto-N-neotetraosa (LNnT) xxxxxxxx kombinovanou xxxxxxxxx xxxxxxxxxxxx xxxxx PS-LNnT-JBT x&xxxx;XX-XXxX-XXX xxxxx Xxxxxxxxxxx xxxx BL21(DE3) xxxxxxx xxxxxxxxx čl. 12 xxxx.&xxxx;1 xxxxxxxx (EU) 2015/2283. |
|
(12) |
Xx xxxxx xxxxxx změnit xxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxx xxxxx-X-xxxxxxxxxxx xxx, aby xxxxxxxxxx xxxxxxxxxx kmeny XX-XXxX-XXX x&xxxx;XX-XXxX-XXX xxxxx Xxxxxxxxxxx coli XX21(XX3) xxxx xxxxxx nových xxxxxxxx xxxxx xxxxxxxxxx xxxxx Escherichia xxxx X12, a změnit navrhované xxxxxx xxx xxxxxxxxxx xxxxxx, xxxxxx x&xxxx;xxxxxxxx. |
|
(13) |
Xxxxxxx xxxxxxxx (EU) 2017/2470 xx proto xxxx xxx xxxxxxxxxxxxx xxxxxxxx xxxxxxx. |
|
(14) |
Xxxxxxxx stanovená xxxxx xxxxxxxxx jsou x&xxxx;xxxxxxx xx xxxxxxxxxxx Xxxxxxx xxxxxx xxx xxxxxxxx, xxxxxxx, potraviny x&xxxx;xxxxxx, |
XXXXXXX XXXX NAŘÍZENÍ:
Xxxxxx&xxxx;1
Xxxxx na seznamu Xxxx xxx povolené xxxx xxxxxxxxx xxxxxxxxxx x&xxxx;xxxxxx&xxxx;6 xxxxxxxx (EU) 2015/2283 týkající se xxxxx xxxxx-X-xxxxxxxxxxx (xxxxxxxxxxx xxxxx) xx xxxx xxxxx přílohy xxxxxx xxxxxxxx.
Xxxxxx&xxxx;2
Xxxx xxxxxxxx vstupuje x&xxxx;xxxxxxxx xxxxxxxx dnem xx xxxxxxxxx v Úředním xxxxxxxx Xxxxxxxx unie.
Xxxx xxxxxxxx xx xxxxxxx v celém xxxxxxx x&xxxx;xxxxx použitelné xx xxxxx členských xxxxxxx.
X&xxxx;Xxxxxxx xxx 4.&xxxx;xxxxxx 2021.
Xx Xxxxxx
xxxxxxxxxxx
Xxxxxx VON XXX XXXXX
(1)&xxxx;&xxxx;Xx. xxxx. L 327, 11.12.2015, x.&xxxx;1.
(2)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Xxxxxx (XX) 2017/2470 xx xxx 20. prosince 2017, xxxxxx se xxxxxxx xxxxxx Unie xxx xxxx xxxxxxxxx v souladu x&xxxx;xxxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) 2015/2283 x&xxxx;xxxxxx xxxxxxxxxxx (Xx. xxxx. X&xxxx;351, 30.12.2017, x.&xxxx;72).
(3)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxxxx Xxxxxx (XX) 2016/375 ze xxx 11. března 2016, xxxxxx xx xxxxxxxx uvedení xxxxx-X-xxxxxxxxxxx xx xxx xxxx xxxx xxxxxx xxxxxxxx xxxxx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx a Rady (XX) x.&xxxx;258/97 (Xx. xxxx. L 70, 16.3.2016, x.&xxxx;22).
(4)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) č. 258/97 x&xxxx;xxxxxx xxxxxxxxxxx x&xxxx;xxxxxx xxxxxxxx xxxxxxxx (Úř. xxxx. X&xxxx;43, 14.2.1997, x.&xxxx;1).
(5)&xxxx;&xxxx;XXXX Xxxxxxx 2020;18(11):6305.
XXXXXXX
X&xxxx;xxxxxxx 2 (Xxxxxxxxxxx) xxxxxxx xxxxxxxxxxx nařízení (XX) 2017/2470 se xxxxx xxxxxxxx se „Xxxxx-X-xxxxxxxxxxx (xxxxxxxxxxx xxxxx)“ xxxxxxxxx xxxxx:
|
„Xxxxx-X-xxxxxxxxxxx (xxxxxxxxxxx xxxxx) |
Xxxxxxxx: Xxxxxxxx xxxxx: β-D-galaktopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glukopyranosyl-(1→3)-β-D-galaktopyranosyl-(1→4)-D-glukopyranosa Chemický xxxxxx: X26X45XX21 XXX: 13007-32-4 Molekulová xxxxxxxx: 707,63&xxxx;x/xxx Xxxxx:
Xxxxx: Xxxxx-X-xxxxxxxxxxx xx xxxx xx xxxxxx xxxxxxxxxxx xxxxxx, který xx xxxxxx xxxxxxxxxxxxxxxx xxxxxxxx. Xxxxxxx: Xxxxx (xxx vody): ≥&xxxx;80&xxxx;% X-xxxxxxx: ≤&xxxx;10,0&xxxx;% Xxxxx-X-xxxxxx XX: ≤&xxxx;3,0&xxxx;% Xxxx-xxxxx-X-xxxxxxxxxx: ≤&xxxx;5,0&xxxx;% Xxxxxxxxxx izomer xxxxx-X-xxxxxxxxxxx: ≤&xxxx;1,0&xxxx;% Xxxx xxxxxxxxx (lakto-N-neotetraosy, X-xxxxxxx, xxxxx-X-xxxxxx II, xxxx-xxxxx-X-xxxxxxxxxx, fruktosového xxxxxxx xxxxx-X-xxxxxxxxxxx): ≥&xxxx;92&xxxx;% (% xxxxxxxxxxxx sušiny) pH (20&xxxx;°X, 5&xxxx;% xxxxxx): 4,0–7,0 Xxxx: ≤&xxxx;9,0&xxxx;% Xxxxxxxxx xxxxx: ≤&xxxx;1,0&xxxx;% Xxxxxxxx xxxxxxxxxxxx (xxxxxxxx): ≤&xxxx;100&xxxx;xx/xx Xxxxxxxx xxxxxxxxx: ≤&xxxx;0,01&xxxx;% Xxxxxxxxxxxxxxx kritéria: Celkový xxxxx aerobních xxxxxxxxxxx xxxxxxxx: ≤&xxxx;500 XXX/x Xxxxxxxx x&xxxx;xxxxxx: ≤&xxxx;50 XXX/x Xxxxxxxx xxxxxxxxxx: ≤ 10 XX/xx XXX: xxxxxxx xxxxxxx jednotky; XX: xxxxxxxxxxxx jednotky“ |