PROVÁDĚCÍ XXXXXXXX XXXXXX (XX) 2021/912
xx xxx 4.&xxxx;xxxxxx 2021,
xxxxxx se xxxxxxxx xxxxx xxxxxxxxxxx xxxx xxxxxxxxx lakto-N-neotetraosy (xxxxxxxxxxx xxxxx) x&xxxx;xxxxxx xx xxxx xxxxxxxxx xxxxxxxx (XX) 2017/2470
(Xxxx x&xxxx;xxxxxxxx pro XXX)
XXXXXXXX XXXXXX,
x&xxxx;xxxxxxx xx Smlouvu x&xxxx;xxxxxxxxx Xxxxxxxx unie,
s ohledem xx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (EU) 2015/2283 xx dne 25.&xxxx;xxxxxxxxx&xxxx;2015 x&xxxx;xxxxxx xxxxxxxxxxx, x&xxxx;xxxxx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx a Rady (XX) x.&xxxx;1169/2011 a o zrušení xxxxxxxx Xxxxxxxxxx parlamentu x&xxxx;Xxxx (XX) č. 258/97 x&xxxx;xxxxxxxx Xxxxxx (XX) x.&xxxx;1852/2001&xxxx;(1), x&xxxx;xxxxxxx xx článek 12 xxxxxxxxx xxxxxxxx,
xxxxxxxx k těmto xxxxxxx:
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(1) |
Xxxxxxxx (XX) 2015/2283 xxxxxxx, xx xx xxx v Unii smějí xxx xxxxxxx xxxxx xxxx potraviny xxxxxxxx x&xxxx;xxxxxxxx na xxxxxx Xxxx. |
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(2) |
Xxxxx xxxxxx&xxxx;8 xxxxxxxx (XX) 2015/2283 xxxx xxxxxxx xxxxxxxxx nařízení Xxxxxx (EU) 2017/2470 (2), xxxxxx se xxxxxxx xxxxxx Unie pro xxxxxxxx xxxx xxxxxxxxx. |
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(3) |
Xxxxx xxxxxx&xxxx;12 nařízení (XX) 2015/2283 Xxxxxx xxxxxxxxx xxxxx xxxxxxxxxxx xxxx, xxxxxx xx xxxxxxxx xxxxxxx nové xxxxxxxxx xx trh v Unii x&xxxx;xxxxxx xx xxxxxxxxxxx xxxxxx Xxxx. |
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(4) |
Xxxxxxxxxx xxxxxxxxxxx Xxxxxx (XX) 2016/375&xxxx;(3) xx x&xxxx;xxxxxxx x&xxxx;xxxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;258/97&xxxx;(4) povolilo xxxxxxx xxxxxxxx syntetizované xxxxx-X-xxxxxxxxxxx xx xxx xxxx xxxx xxxxxx xxxxxxxx. |
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(5) |
Xxxxx xxxxxx&xxxx;5 nařízení (XX) č. 258/97 xxxxxxxxxxx xxxxxxxxxx Xxxxxx X/X&xxxx;xxx 1.&xxxx;xxxx&xxxx;2016 Xxxxxx x&xxxx;xxxx xxxxxx uvést xx xxx jako novou xxxxxx xxxxxxxx xxxxxxx xxxxx-X-xxxxxxxxxxx x&xxxx;xxxxxxxxxxxxx xxxxxx xxxxxxxx x&xxxx;xxxxx Xxxxxxxxxxx xxxx X-12. |
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(6) |
Xxxxxxxxxx Xxxxxx X/X&xxxx;x xxxxxxxx Xxxxxx xxxx xxxxxxxxxx xxxxxx xxxxxxx xxxxxxxxxx xxxxxxx x&xxxx;Xxxxx xxxxx čl. 3 xxxx.&xxxx;4 xxxxxxxx (ES) x.&xxxx;258/97, xxxxx xx xxxxxxx vědeckých důkazů xxxxxxxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxx k závěru, že xxxxx-X-xxxxxxxxxxx xxxxxxxx z kmene Xxxxxxxxxxx xxxx X-12 xx x&xxxx;xxxxxxxxx xxxx xxxxxxxxxx syntetické xxxxx-X-xxxxxxxxxxx xxxxxxxx prováděcím xxxxxxxxxxx (XX) 2016/375. Xxxxx-X-xxxxxxxxxxx x&xxxx;xxxxxxxxxxxxx xxxxxx xxxx xxxxx přidána xx xxxxxx Xxxx xxx xxxx potraviny. |
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(7) |
Dne 23.&xxxx;xxxxxx&xxxx;2019 xxxxxxxxxx xxxxxxxxxx Xxx. Xxxxxx A/S (dále jen „xxxxxxx“) Komisi xxxxxx x&xxxx;xxxxxxx x&xxxx;xx.&xxxx;10 xxxx.&xxxx;1 xxxxxxxx (EU) 2015/2283 x&xxxx;xxxxxxxx xxxxx-X-xxxxxxxxxxx (mikrobiální xxxxx) vyráběné xxxxxxxxxxxx xxxxxxxxx derivovaných xxxxx XX-XXxX-XXX a DS-LNnT-JBT xxxxx Xxxxxxxxxxx coli 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 x&xxxx;xxxxxxxxxxx xxxxxxx Xxxx, pokud xxx x&xxxx;xxxx xxxxx této xxxx xxxxxxxxx. |
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(8) |
Xxxxx toho xxxxxxx navrhl aktualizovat xxxxxxx xxxxxxxxxxx xxxxx-X-xxxxxxxxxxx (xxxxxxxxxxx xxxxx) vyráběné x&xxxx;xxxxxx xxxxxx xxxxxx, xxxxx xx liší xx specifikací xxxxxxxx xxxxx-X-xxxxxxxxxxx x&xxxx;xxxxxxxxxxxxxxxxx zdroje xxxxxxxx x&xxxx;xxxxx Xxxxxxxxxxx xxxx X-12, xxxxx xxx x&xxxx;xxxxxxx xxxxxx xxxxxx z ≤ 0,4 % na ≤&xxxx;1,0&xxxx;%, xxxxx xxxxxx xxx xxxxxxxxxx xxxxxxxx x&xxxx;xxxxxx ze xxxxxxxxxxx ≤&xxxx;10 kolonii xxxxxxxxx xxxxxxxx („XXX“)/x xxxx xxxxxxxxx pro každý xxx xxxxxxxxxxxxxx xx ≤&xxxx;50 XXX/x xxx xxxxxxxxx obou x&xxxx;xxxxxxxxxxxx xxxxxxxxx (xx xxxxxxxx xxxxxxx ≤&xxxx;100&xxxx;xx/xx) x&xxxx;xxxxxxxxxxxx xxxxxxx xxxxx-X-xxxxxxxxxxx (xx xxxxxxxx xxxxxxx ≤&xxxx;1,0&xxxx;%). |
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(9) |
Xxx 17.&xxxx;xxxxx&xxxx;2020 požádala Xxxxxx Xxxxxxxx xxxx xxx xxxxxxxxxx xxxxxxxx (xxxx xxx „úřad“), xxx xxxxxxx xxxxxxxxx xxxxx-X-xxxxxxxxxxx xxxxxxxx kombinovanou xxxxxxxxx xxxxxxxxxxxx xxxxx XX-XXxX-XXX x&xxxx;XX-XXxX-XXX xxxxx Xxxxxxxxxxx xxxx XX21(XX3) x&xxxx;xxxxxxx x&xxxx;xxxxxxxxx článku 11 xxxxxxxx (XX) 2015/2283. |
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(10) |
Xxx 22.&xxxx;xxxxx&xxxx;2020 xxxxxx xxxx xxxxxxx xxxxxxxxxx x&xxxx;xxxxxx „Xxxxxx xx xxxxx-X-xxxxxxxxxxx (XXxX) xxxxxxxx by xxxxxxxxxx xxxxxxx xx X. xxxx BL21 xx x&xxxx;xxxxx food pursuant xx Xxxxxxxxxx (XX) 2015/2283“&xxxx;(5). |
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(11) |
Xx svém vědeckém xxxxxxxxxx xxxx xxxxxx x&xxxx;xxxxxx, xx lakto-N-neotetraosa (XXxX) xxxxxxxx kombinovanou xxxxxxxxx derivovaných xxxxx XX-XXxX-XXX x&xxxx;XX-XXxX-XXX kmene Xxxxxxxxxxx xxxx XX21(XX3) xx xxxx xxxx xxxxxxxxx xxxxx xxxxxxxx (XX) 2015/2283 xx xxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxx bezpečná. Xxxxxxx xxxxxxx stanovisko tudíž xxxxxxxxx xxxxxxxxxx xxxxxx xx stanovení xxxx, xx lakto-N-neotetraosa (LNnT) xxxxxxxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxxxxxx kmenů XX-XXxX-XXX x&xxxx;XX-XXxX-XXX xxxxx Escherichia xxxx XX21(XX3) splňuje xxxxxxxxx čl. 12 xxxx.&xxxx;1 xxxxxxxx (XX) 2015/2283. |
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(12) |
Je xxxxx xxxxxx xxxxxx xxxxxxxxxxx xxxxxxxxxxxxxxx vyráběné xxxxx-X-xxxxxxxxxxx xxx, aby xxxxxxxxxx xxxxxxxxxx xxxxx XX-XXxX-XXX a DS-LNnT-JBT kmene Xxxxxxxxxxx coli BL21(DE3) xxxx zdroje xxxxxx xxxxxxxx xxxxx povoleného xxxxx Xxxxxxxxxxx xxxx X12, x&xxxx;xxxxxx navrhované xxxxxx xxx xxxxxxxxxx xxxxxx, plísní x&xxxx;xxxxxxxx. |
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(13) |
Xxxxxxx xxxxxxxx (XX) 2017/2470 xx xxxxx xxxx xxx xxxxxxxxxxxxx xxxxxxxx xxxxxxx. |
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(14) |
Xxxxxxxx xxxxxxxxx tímto xxxxxxxxx jsou v souladu xx stanoviskem Xxxxxxx xxxxxx pro rostliny, xxxxxxx, potraviny x&xxxx;xxxxxx, |
XXXXXXX XXXX NAŘÍZENÍ:
Xxxxxx&xxxx;1
Xxxxx xx xxxxxxx Xxxx xxx povolené xxxx potraviny xxxxxxxxxx x&xxxx;xxxxxx&xxxx;6 xxxxxxxx (XX) 2015/2283 xxxxxxxx xx xxxxx xxxxx-X-xxxxxxxxxxx (mikrobiální xxxxx) se mění xxxxx xxxxxxx xxxxxx xxxxxxxx.
Xxxxxx&xxxx;2
Xxxx xxxxxxxx xxxxxxxx x&xxxx;xxxxxxxx dvacátým xxxx xx xxxxxxxxx v Úředním xxxxxxxx Evropské unie.
Xxxx xxxxxxxx xx xxxxxxx x&xxxx;xxxxx xxxxxxx x&xxxx;xxxxx xxxxxxxxxx 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 nařízení Xxxxxx (XX) 2017/2470 xx xxx 20.&xxxx;xxxxxxxx&xxxx;2017, xxxxxx xx xxxxxxx xxxxxx Unie xxx xxxx xxxxxxxxx x&xxxx;xxxxxxx x&xxxx;xxxxxxxxx Xxxxxxxxxx parlamentu x&xxxx;Xxxx (EU) 2015/2283 x&xxxx;xxxxxx xxxxxxxxxxx (Xx. xxxx. X&xxxx;351, 30.12.2017, x.&xxxx;72).
(3)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxxxx Komise (XX) 2016/375 xx xxx 11.&xxxx;xxxxxx&xxxx;2016, kterým xx xxxxxxxx xxxxxxx xxxxx-X-xxxxxxxxxxx xx xxx xxxx nové xxxxxx xxxxxxxx xxxxx xxxxxxxx Xxxxxxxxxx parlamentu x&xxxx;Xxxx (XX) x.&xxxx;258/97 (Xx. xxxx. X&xxxx;70, 16.3.2016, x.&xxxx;22).
(4)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;258/97 x&xxxx;xxxxxx potravinách x&xxxx;xxxxxx xxxxxxxx xxxxxxxx (Xx. 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 xx xxxxx xxxxxxxx xx „Xxxxx-X-xxxxxxxxxxx (xxxxxxxxxxx zdroj)“ xxxxxxxxx xxxxx:
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„Xxxxx-X-xxxxxxxxxxx (xxxxxxxxxxx xxxxx) |
Xxxxxxxx: Xxxxxxxx xxxxx: β-X-xxxxxxxxxxxxxxxx-(1→4)-2-xxxxxxxxx-2-xxxxx-β-X-xxxxxxxxxxxxxx-(1→3)-β-X-xxxxxxxxxxxxxxxx-(1→4)-X-xxxxxxxxxxxxx Xxxxxxxx xxxxxx: X26X45XX21 XXX: 13007-32-4 Molekulová xxxxxxxx: 707,63&xxxx;x/xxx Xxxxx:
Xxxxx: Xxxxx-X-xxxxxxxxxxx xx xxxx xx xxxxxx krystalický xxxxxx, xxxxx se xxxxxx xxxxxxxxxxxxxxxx procesem. Čistota: Obsah (xxx xxxx): ≥ 80 % D-laktosa: ≤&xxxx;10,0&xxxx;% Xxxxx-X-xxxxxx XX: ≤ 3,0 % Para-lakto-N-neohexaosa: ≤&xxxx;5,0&xxxx;% Xxxxxxxxxx izomer xxxxx-X-xxxxxxxxxxx: ≤&xxxx;1,0&xxxx;% Xxxx xxxxxxxxx (xxxxx-X-xxxxxxxxxxx, X-xxxxxxx, xxxxx-X-xxxxxx II, xxxx-xxxxx-X-xxxxxxxxxx, xxxxxxxxxxxx xxxxxxx xxxxx-X-xxxxxxxxxxx): ≥&xxxx;92&xxxx;% (% xxxxxxxxxxxx sušiny) pH (20 °C, 5&xxxx;% xxxxxx): 4,0–7,0 Voda: ≤&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 xxxxxxxx: Xxxxxxx xxxxx xxxxxxxxx xxxxxxxxxxx xxxxxxxx: ≤&xxxx;500 KTJ/g Kvasinky x&xxxx;xxxxxx: ≤ 50 XXX/x Xxxxxxxx xxxxxxxxxx: ≤&xxxx;10 XX/xx XXX: xxxxxxx xxxxxxx jednotky; XX: xxxxxxxxxxxx jednotky“ |