XXXXXXXXX XXXXXXXX XXXXXX (XX) 2023/61
xx dne 5.&xxxx;xxxxx 2023
x&xxxx;xxxxxxxx xxxxxxxxx xxxx-1,4-xxxx-xxxxxxxxx z Aspergillus niger XXX 120604, xxxxxxxxx xxxx-1,3(4)-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxxxx XXXX 39199, xxxxxxxxx xxxx-1,4-xxxx-xxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxxxxxxxxx XXXX 39203 a přípravku xxxx-1,4-xxxx-xxxxxxxx z Trichoderma citrinoviride XXX 614.94&xxxx;xxxx xxxxxxxxxxx xxxxx xxx xxxxxxx xxxxx xxxxxx
(Xxxx x&xxxx;xxxxxxxx xxx XXX)
XXXXXXXX XXXXXX,
x&xxxx;xxxxxxx xx Smlouvu o fungování Xxxxxxxx unie,
s ohledem xx xxxxxxxx Evropského xxxxxxxxxx x&xxxx;Xxxx (ES) x.&xxxx;1831/2003 xx dne 22.&xxxx;xxxx&xxxx;2003 x&xxxx;xxxxxxxxxxx xxxxxxx xxxxxxxxxxx xx výživě xxxxxx&xxxx;(1), x&xxxx;xxxxxxx na xx.&xxxx;9 xxxx.&xxxx;2 uvedeného xxxxxxxx,
xxxxxxxx x&xxxx;xxxxx xxxxxxx:
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(1) |
Xxxxxxxx (ES) x.&xxxx;1831/2003 xxxxxxx xxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxx xx xxxxxx xxxxxx x&xxxx;xxxxxx x&xxxx;xxxxxxx, xx xxxxxxx základě xx xxxxxxxx uděluje. X&xxxx;xx.&xxxx;10 xxxx.&xxxx;2 uvedeného nařízení xx xxxxxxx přehodnocení xxxxxxxxxxx látek xxxxxxxxxx xxxxx xxxxxxxx Xxxx 70/524/XXX&xxxx;(2). X&xxxx;xx.&xxxx;10 xxxx.&xxxx;7 xxxxxxxx (ES) x.&xxxx;1831/2003 xx xxxxxxx xxxxxxxx xxxxxxxxxx xxx xxxxxxx xx trh x&xxxx;xxxxxxxxx xxxxxxxx xxxxxxxxxxx x&xxxx;Xxxx xxxx doplňkové xxxxx x&xxxx;xxxxxxxxxx. |
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(2) |
Xxxxxxxxx endo-1,4-beta-glukanázy x&xxxx;Xxxxxxxxxxx xxxxx XXX 120604, xxxx-1,3(4)-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxxxx XXXX 39199, endo-1,4-beta-xylanázy x&xxxx;Xxxxxxxxxxx citrinoviride MUCL 39203 a endo-1,4-beta-xylanázy x&xxxx;Xxxxxxxxxxx xxxxxxxxxxxxx XXX 614.94 xxxx zapsány xx xxxxxxxx pro xxxxxxxxx xxxxx jako xxxxxxxxx xxxxxxxx&xxxx;(3) pro xxxxxxx xxxxx zvířat xxxxxxxxxx xx funkční skupiny „xxxxxxxxx xxxxx x&xxxx;xxxxxxxxxx“ x&xxxx;xxxxxxx x&xxxx;xx.&xxxx;10 xxxx.&xxxx;1 xxxx. x) xxxxxxxx (XX) č. 1831/2003. |
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(3) |
V souladu x&xxxx;xx.&xxxx;10 xxxx.&xxxx;7 nařízení (ES) x.&xxxx;1831/2003 xx xxxxxxx x&xxxx;xx.&xxxx;10 odst. 2 x&xxxx;xxxxxxx&xxxx;7 xxxxxxxxx xxxxxxxx xxxx xxxxxx xxxxxx x&xxxx;xxxxxxxx xxxxxxxxx xxxx-1,4-xxxx-xxxxxxxxx z Aspergillus xxxxx XXX 120604, xxxx-1,3(4)-xxxx-xxxxxxxxx z Aspergillus xxxxxxxx XXXX 39199, xxxx-1,4-xxxx-xxxxxxxx x&xxxx;Xxxxxxxxxxx citrinoviride MUCL 39203 x&xxxx;xxxx-1,4-xxxx-xxxxxxxx z Trichoderma xxxxxxxxxxxxx CBS 614.94&xxxx;xxxx xxxxxxxxxxx xxxxx xxx xxxxxxx xxxxx xxxxxx. Xxxxxxx xxxxxxx x&xxxx;xxxxxxxx xxxxxxxxx přípravků xx xxxxxxxxx xxxxxxxxxxx xxxxx „xxxxxxxxxxxxx doplňkové xxxxx“ x&xxxx;xxxxxxx skupiny „xxxxxxxxx xxxxx k silážování“. Xxxx xxxxxx byla xxxxxxxxxx xxxxx s údaji x&xxxx;xxxxxxxxx xxxxxxxxxxxx xxxxx xx.&xxxx;7 xxxx.&xxxx;3 xxxxxxxx (ES) x.&xxxx;1831/2003. |
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(4) |
Xxxxxxxx úřad xxx xxxxxxxxxx xxxxxxxx (dále xxx „xxxx“) xx xxxxx xxxxxxxxxxxx ze xxx 7. března 2018 (4) a ze xxx 29.&xxxx;xxxxxx&xxxx;2022&xxxx;(5) xxxxxx x&xxxx;xxxxxx, xx xx xxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxx xxxxxx na xxxxxx xxxxxx, xxxxxx xxxxxxxxxxxx xxx xx xxxxxxx prostředí. Xxxx xxxxxx xxxxxx x&xxxx;xxxxxx, xx xxxxxxxx k nedostatku xxxxx xxxxx xxxxxxx xxxxx xxxxx xxxxxxx xxxxxxxxxxx těchto xxxxxxxxxxx xxxxx xxx kůži x&xxxx;xxx a ohledně xxxxxx xxxxxxxxxx senzibilizace xxxx. Xxxxxxxx k bílkovinné xxxxxx xxxxxxxx xxxxx xx xxxx xxxxxxxxx měly xxx xxxxxxxxxx xx xxxxx potenciálně senzibilizující xxxxxxx cesty. Xxxx xx xxxx xxxxxxxxxx xx dne 29. června 2022 xxxx xxxxxx k závěru, xx xxxxxxx přípravky xxxx xxxxxxxxx xxxxxxx xxxxxx siláže x&xxxx;xxxxxxxxx, xxxxx xxx silážovat xxxxxx, x&xxxx;xxxxxxx obtížemi x&xxxx;xxxxxxx. Xxxx xxxx xxxxxx xxxxxx x&xxxx;xxxxxxxx xxxxxxx doplňkových xxxxx xxxxxxxxx xx xxxxx, xxxxxx xxxxxxxxxx referenční xxxxxxxxx xxxxxxx xxxxxxxxx (XX) x.&xxxx;1831/2003. |
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(5) |
Xxxxxxxxx xxxxxxxxx xxxx-1,4-xxxx-xxxxxxxxx z Aspergillus xxxxx XXX 120604, xxxx-1,3(4)-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx neoniger MUCL 39199, xxxx-1,4-xxxx-xxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxxxxxxxxx MUCL 39203 x&xxxx;xxxx-1,4-xxxx-xxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxxxxxxxxx XXX 614.94 prokazuje, xx podmínky xxx xxxxxxxx stanovené x&xxxx;xxxxxx&xxxx;5 xxxxxxxx (XX) x.&xxxx;1831/2003 xxxx xxxxxxx. Xxxxxxxxx xxxxxxxxx xxxxxxxxx xx xxxxx xxxx xxx xxxxxxxx. Xxxxxx xx xxxxxxx, xx xx xxxx xxx xxxxxxx xxxxxx xxxxxxxx xxxxxxxx, xxx xx zabránilo xxxxxxxxxxx xxxxxxx xx xxxxxx xxxxxx, zejména xxxxx xxx x&xxxx;xxxxxxxxx xxxxxxx xxxxxxxxx xxxxx. |
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(6) |
Xxxxxxxx x&xxxx;xxxx, xx xxxxxxxxxxxx xxxxxx xxxxxxxxxx okamžité xxxxxxxxx xxxx x&xxxx;xxxxxxxxxx xxx xxxxxxxx dotčených xxxxxxxxx, xx xxxxxx xxxxxxxx přechodné období, xxxxx xxxxxxxxxxx xxxxxxx xxxxxx xxxxxxxxx xx xx xxxxxx nových xxxxxxxxx xxxxxxxxxxxxx x&xxxx;xxxxxxxx. |
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(7) |
Xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxx x&xxxx;xxxxxxx xx xxxxxxxxxxx Xxxxxxx výboru xxx xxxxxxxx, xxxxxxx, xxxxxxxxx a krmiva, |
PŘIJALA TOTO XXXXXXXX:
Článek 1
Povolení
Přípravky xxxxxxx x&xxxx;xxxxxxx, xxxxxxxxxx xx xxxxxxxxx xxxxxxxxxxx xxxxx „xxxxxxxxxxxxx xxxxxxxxx látky“ a funkční xxxxxxx „xxxxxxxxx xxxxx x&xxxx;xxxxxxxxxx“, xx povolují xxxx xxxxxxxxx xxxxx xx xxxxxx xxxxxx xxxxx xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxx xxxxxxx.
Xxxxxx&xxxx;2
Xxxxxxxxx xxxxxxxx
1.&xxxx;&xxxx;&xxxx;Xxxxxxxxx xxxxxxx x&xxxx;xxxxxxx a premixy obsahující xxxx xxxxxxxxx, xxxxxxxx x&xxxx;xxxxxxxx xxxxx xxxx 26.&xxxx;xxxxxxxx 2023 x&xxxx;xxxxxxx x&xxxx;xxxxxxxx platnými xxxxx xxxx 26.&xxxx;xxxxx 2023, xxxxx být xxxxxxx xx trh a používány xx xx xxxxxxxxx xxxxxxxxxxx xxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxx směsi x&xxxx;xxxxx suroviny xxxxxxxxxx xxxxxxxxx uvedené x&xxxx;xxxxxxx, xxxxxxxx a označené xxxxx xxxx 26.&xxxx;xxxxx 2024 x&xxxx;xxxxxxx x&xxxx;xxxxxxxx platnými xxxxx dnem 26.&xxxx;xxxxx 2023, mohou být xxxxxxx xx trh x&xxxx;xxxxxxxxx xx xx xxxxxxxxx xxxxxxxxxxx xxxxx, xxxxxxxx jsou xxxxxx xxx xxxxxxx xxxxxx x&xxxx;xxxxxxxx xxxxxxxx.
3.&xxxx;&xxxx;&xxxx;Xxxxx směsi x&xxxx;xxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxx x&xxxx;xxxxxxx, xxxxxxxx a označené xxxxx xxxx 26.&xxxx;xxxxx 2025 x&xxxx;xxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxxx xxxx 26. ledna 2023, mohou být xxxxxxx na trh x&xxxx;xxxxxxxxx xx xx xxxxxxxxx xxxxxxxxxxx xxxxx, xxxxxxxx jsou xxxxxx xxx xxxxxxx xxxxxxxx x&xxxx;xxxxxxxx potravin.
Xxxxxx&xxxx;3
Xxxxx v platnost
Toto xxxxxxxx xxxxxxxx x&xxxx;xxxxxxxx xxxxxxxx xxxx xx vyhlášení x&xxxx;Xxxxxxx věstníku Evropské xxxx.
Toto xxxxxxxx je xxxxxxx x&xxxx;xxxxx xxxxxxx x&xxxx;xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx xxxxxxx.
X&xxxx;Xxxxxxx xxx 5. ledna 2023.
Za Xxxxxx
xxxxxxxxxxx
Xxxxxx XXX XXX XXXXX
(1)&xxxx;&xxxx;Xx.&xxxx;xxxx.&xxxx;X&xxxx;268, 18.10.2003, x.&xxxx;29.
(2)&xxxx;&xxxx;Xxxxxxxx Xxxx 70/524/XXX xx xxx 23.&xxxx;xxxxxxxxx&xxxx;1970 x&xxxx;xxxxxxxxxxx xxxxxxx x&xxxx;xxxxxxxx (Xx.&xxxx;xxxx.&xxxx;X&xxxx;270, 14.12.1970, x.&xxxx;1).
(3)&xxxx;&xxxx;X&xxxx;xxxxxxxx xxx xxxxxxxxx xxxxx: endo-1,4-beta-glukanáza x&xxxx;Xxxxxxxxxxx xxxxx XXX 120604 byla xxxxxxxxxxxxxx xxxx xxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxx CBS 120604; xxxx-1,3(4)-xxxx-xxxxxxxxx x&xxxx;Xxxxxxxxxxx neoniger XXXX 39199 xxxx xxxxxxxxxxxxxx jako beta-glukanáza x&xxxx;Xxxxxxxxxxx xxxxx XXXX 39199 xxxx Aspergillus xxxxxxxxxxx XXXX 39199; xxxx-1,4-xxxx-xxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxxxxxxxxx XXXX 39203 xxxx xxxxxxxxxxxxxx xxxx xylanáza x&xxxx;Xxxxxxxxxxx longibrachiatum XXXX 39203 nebo Trichoderma xxxxxxxx MUCL 39203; xxxx-1,4-xxxx-xxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxxxxxxxxx XXX 614.94 byla xxxxxxxxxxxxxx xxxx xxxxxxxx x&xxxx;Xxxxxxxxxxx longibrachiatum CBS 614.94.
(4)&xxxx;&xxxx;XXXX Journal 2018;16(4):5224.
(5)&xxxx;&xxxx;XXXX Xxxxxxx 2022;20(7):7425.
PŘÍLOHA
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Xxxxxxx, xxxxxxxx xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx nebo xxxxxxxxx xxxxxx |
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Xxxxxxxxx: xxxxxxxxxxxxx doplňkové látky. Xxxxxxx skupina: doplňkové xxxxx x&xxxx;xxxxxxxxxx. |
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1x105 |
Xxxx-1,4-xxxx-xxxxxxxxx (XX 3.2.1.4) |
Xxxxxxx doplňkové xxxxx: Xxxxxxxxx xxxx-1,4-xxxx-xxxxxxxxx z: Aspergillus xxxxx XXX 120604, x&xxxx;xxxxxxx xxxxxxxx 25 650 DNS (1)/g xxxxxxxxx xxxxx Xxxxx forma Charakteristika xxxxxx xxxxx: Xxxx-1,4-xxxx-xxxxxxxxx (EC 3.2.1.4) x&xxxx;Xxxxxxxxxxx niger XXX 120604 Xxxxxxxxxx metoda (2) Xxx xxxxxxxxx xxxx-1,4-xxxx-xxxxxxxxx x&xxxx;xxxxxxxxx xxxxx:
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Xxxxxxx, chemický xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx kategorie xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
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Xxxx xxxxxxxxxx |
Xxxxx xxxxxxxxx xxxxxxxx |
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Xxxxxxxx xxxxxxxx xxxxxxxxx xxxxx/xx čerstvého xxxxxxxxx |
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Xxxxxxxxx: xxxxxxxxxxxxx xxxxxxxxx látky. Xxxxxxx skupina: xxxxxxxxx xxxxx x&xxxx;xxxxxxxxxx. |
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1x106 |
Xxxx-1,3(4)-xxxx-xxxxxxxxx (XX 3.2.1.6) |
Složení xxxxxxxxx xxxxx: Xxxxxxxxx xxxx-1,3(4)-xxxx-xxxxxxxxx x: Xxxxxxxxxxx xxxxxxxx XXXX 39199, x&xxxx;xxxxxxx aktivity 10&xxxx;000 XXX (3)/x xxxxxxxxx xxxxx Xxxxx xxxxx Xxxxxxxxxxxxxxx xxxxxx xxxxx: Xxxx-1,3(4)-xxxx-xxxxxxxxx (EC 3.2.1.6) x&xxxx;Xxxxxxxxxxx xxxxxxxx XXXX 39199 Xxxxxxxxxx xxxxxx (4) Xxx xxxxxxxxx xxxx-1,3(4)-xxxx-xxxxxxxxx v doplňkové xxxxx:
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Xxxxxxx xxxxx zvířat |
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Identifikační xxxxx doplňkové xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, xxxxxxxx vzorec, xxxxx, xxxxxxxxxx metoda |
Druh xxxx xxxxxxxxx xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx obsah |
Jiná xxxxxxxxxx |
Xxxxx xxxxxxxxx povolení |
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Jednotky xxxxxxxx xxxxxxxxx látky/kg xxxxxxxxx materiálu |
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Kategorie: xxxxxxxxxxxxx xxxxxxxxx xxxxx. Funkční xxxxxxx: xxxxxxxxx xxxxx x&xxxx;xxxxxxxxxx. |
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1x107 |
Xxxx-1,4-xxxx-xxxxxxxx (XX 3.2.1.8) |
Složení xxxxxxxxx xxxxx: Xxxxxxxxx xxxx-1,4-xxxx-xxxxxxxx x: Xxxxxxxxxxx xxxxxxxxxxxxx XXXX 39203, s minimem xxxxxxxx 51&xxxx;600 XXX (5)/x xxxxxxxxx xxxxx Xxxxx xxxxx Xxxxxxxxxxxxxxx xxxxxx látky: Endo-1,4-beta-xylanáza (XX 3.2.1.8) z Trichoderma citrinoviride XXXX 39203 Xxxxxxxxxx metoda (6) Xxx stanovení xxxx-1,4-xxxx-xxxxxxxx x&xxxx;xxxxxxxxx xxxxx:
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Xxxxxxx xxxxx zvířat |
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Xxxxxxxxxxxxx xxxxx xxxxxxxxx xxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxx, xxxxxxxx xxxxxx, xxxxx, xxxxxxxxxx xxxxxx |
Xxxx xxxx kategorie xxxxxx |
Xxxxxxxxx xxxxx |
Xxxxxxxxx obsah |
Maximální xxxxx |
Xxxx xxxxxxxxxx |
Xxxxx platnosti povolení |
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Jednotky xxxxxxxx xxxxxxxxx xxxxx/xx xxxxxxxxx xxxxxxxxx |
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Xxxxxxxxx: xxxxxxxxxxxxx xxxxxxxxx xxxxx. Xxxxxxx xxxxxxx: xxxxxxxxx látky x&xxxx;xxxxxxxxxx. |
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1x108 |
Xxxx-1,4-xxxx-xxxxxxxx (XX 3.2.1.8) |
Xxxxxxx xxxxxxxxx xxxxx: Xxxxxxxxx xxxx-1,4-xxxx-xxxxxxxx x: Xxxxxxxxxxx xxxxxxxxxxxxx CBS 614.94, x&xxxx;xxxxxxx aktivity 70&xxxx;000 XXX (7)/x doplňkové látky Pevná xxxxx Xxxxxxxxxxxxxxx xxxxxx látky: Endo-1,4-beta-xylanáza (XX 3.2.1.8) z Trichoderma xxxxxxxxxxxxx CBS 614.94 Xxxxxxxxxx xxxxxx (8) Xxx xxxxxxxxx xxxx-1,4-xxxx-xxxxxxxx x&xxxx;xxxxxxxxx látce:
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Xxxxxxx xxxxx zvířat |
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26.&xxxx;xxxxx 2033 |
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(1)&xxxx;&xxxx;1 xxxxxxxx XXX (3,5-xxxxxxxxxxxxxxxxx xxxxxxxx) xx xxxxxxxx redukujícího xxxxx xxxxxxxxxx xxxx ekvivalenty xxxxxxx x&xxxx;μxxx xx x&xxxx;xx min xxx xX&xxxx;4,5 a 37 °C ze xxxxxx.
(2)&xxxx;&xxxx;Xxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxxxxx xxxxxxxx xxx xxxxxx xx xxxxxxxxxxx xxxxxxx xxxxxxxxxx laboratoře: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
(3) 1 xxxxxxxx XXX (3,5-xxxxxxxxxxxxxxxxx xxxxxxxx) je množství xxxxxxxxxxxx cukru xxxxxxxxxx xxxx ekvivalenty glukózy x&xxxx;μxxx xx x&xxxx;xx xxx xxx xX&xxxx;4,5 x&xxxx;37&xxxx;°X xx xxxxxx.
(4)&xxxx;&xxxx;Xxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxxxxx metodách 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
(5) 1 jednotka XXX (3,5-xxxxxxxxxxxxxxxxx xxxxxxxx) xx xxxxxxxx xxxxxxxxxxxx xxxxx uvolněného xxxx xxxxxxxxxxx xxxxxx x&xxxx;μxxx xx x&xxxx;xx xxx xxx xX&xxxx;4,5 x&xxxx;37&xxxx;°X x&xxxx;xxxxxxxxx xxxxxx.
(6)&xxxx;&xxxx;Xxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxxxxx metodách xxx xxxxxx na xxxxxxxxxxx xxxxxxx referenční xxxxxxxxxx: xxxxx://xxxxx-xxxxxxxx-xxxxxx.xx.xxxxxx.xx/xxxx-xx-xxxx-xxxx-xxxxxxxxx/xxxx-xx-xxxxxxxxxxxxx/xxxx-xx-xxxxxxxxxx-xxxxxxx_xx
(7)&xxxx;&xxxx;1 xxxxxxxx XXX (3,5-xxxxxxxxxxxxxxxxx xxxxxxxx) xx xxxxxxxx xxxxxxxxxxxx xxxxx xxxxxxxxxx xxxx ekvivalenty xxxxxx v μmol xx x&xxxx;xx xxx xxx xX&xxxx;4,5 a 37 °C x&xxxx;xxxxxxxxx xxxxxx.
(8)&xxxx;&xxxx;Xxxxxxxx informace x&xxxx;xxxxxxxxxxxx xxxxxxxx xxx xxxxxx xx internetové xxxxxxx xxxxxxxxxx laboratoře: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en