Směrnice Xxxxxx 2003/95/XX
xx xxx 27. xxxxx 2003,
xxxxxx xx mění xxxxxxxx 96/77/XX, xxxxxx xx stanoví xxxxxxxxxx xxxxxxxx pro xxxxxxx xxxxxxxxxxxxxxx přídatných xxxxx xxxxxx než barviva x xxxxxxxx sladidla
(Text x xxxxxxxx pro XXX)
XXXXXX XXXXXXXXXX XXXXXXXXXXXX,
x xxxxxxx xx xxxxxxx x xxxxxxxx Evropského xxxxxxxxxxxx,
x xxxxxxx na xxxxxxxx Xxxx 89/107/XXX xx dne 21. xxxxxxxx 1988 x xxxxxxxxxx právních xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxxx xx xxxxxxxxxxxxxxx xxxxxxxxxx xxxxx povolených xxx xxxxxxx x xxxxxxxxxxx xxxxxxxx x xxxxxx xxxxxxxx [1], xx xxxxx směrnice Xxxxxxxxxx xxxxxxxxxx x Xxxx 94/34/XX [2], x xxxxxxx xx xx. 3 xxxx. 3 xxxx. x) xxxx xxxxxxxx,
xx konzultaci x Xxxxxxxx výborem pro xxxxxxxxx,
xxxxxxxx x xxxxx xxxxxxx:
(1) Směrnice Evropského xxxxxxxxxx a Rady 95/2/XX xx xxx 20. xxxxx 1995 x xxxxxxxxxxxxxxx xxxxxxxxxx xxxxxxx xxxxxx xxx xxxxxxx x náhradní xxxxxxxx [3], naposledy xxxxxxxxx xxxxxxxx 2001/5/ES [4], xxxxxxx xxxxxx xxxxx, xxxxx xxxxx xxx xxxxxxx xxxx xxxxxxxxxxxxx xxxxxxxx xxxxx xxxx xxx barviva x xxxxxxxx xxxxxxxx.
(2) Xxxxxxxx Xxxxxx 96/77/XX [5] xxxxxxxxx xxxxxxxxx xxxxxxxx 2002/82/XX [6], xxxxxxx xxxxxxxx xxxxxxx xxxxxxxxxx látek xxxxxxxxx xx xxxxxxxx 95/2/XX.
(3) Xxxxxxx výbor xxx xxxxxxxxx xxxxxx ve xxxx stanovisku xx xxx 6. xxxxxx 2002 x závěru, xx xx xxxx xxx xxxxxxxxxx xxxxxxx (xxxxxxxxxxxx) xxxxxxx pod xxx zjistitelnosti. V xxxxxxxx xxxx xx xxxxx xxxxxxxxxxx odpovídající xxxxxxxx x xxxxxxxxxxx xxxxxxxx čistoty stanovených xx xxxxxxxx 96/77/ES.
(4) Xxxxxxxxx xxxxxxxx xxxxxxx xxxxx X 251 xxxxxxxx xxxxx x X 459 β-cyklodextrin xx nutné xxxxxxxxxxx xxxxxxxxxxx xxxxxxx.
(5) Xx xxxxx xxxxxxxxx specifikace x xxxxxxxxxx xxxxxxxx xxx xxxxxxxx xxxxx xxxxxxxx Xxxxxxxxx xxxxxxx xxxxxxxxx FAO x XXX xxx xxxxxxxxxxxxx xxxxxxxx látky (JECFA) x uvedené x Xxxxx Xxxxxxxxxxxx.
(6) Xxxxxxxx 96/77/XX by xxxxx xxxx xxx xxxxxxx.
(7) Xxxxxxxx xxxx směrnice xxxx x xxxxxxx xx xxxxxxxxxxx Xxxxxxx xxxxxx xxx xxxxxxxxxxx xxxxxxx a zdraví xxxxxx,
XXXXXXX XXXX SMĚRNICI:
Xxxxxx 1
Příloha směrnice 96/77/XX xx mění x xxxxxxx x xxxxxxxx xxxx xxxxxxxx.
Xxxxxx 2
Členské státy xxxxxx x xxxxxxxx xxxxxx x správní xxxxxxxx xxxxxxxx xxx xxxxxxxx xxxxxxx s xxxxx směrnicí xxxxxxxxxx xx 1. listopadu 2004. Xxxxxxxxxx x xxxx uvědomí Xxxxxx.
Xxxx xxxxxxxx xxxxxxx xxxxxxxxx xxxxx xxxx xxxxxxxxx xxxxx xx xxxx xxxxxxxx xxxx musí xxx xxxxxx xxxxx xxxxxx xxx jejich xxxxxxx xxxxxxxxx. Způsob xxxxxx xx xxxxxxx xxxxxxx xxxxx.
Xxxxxx 3
Xxxxxxx xxxxxxx xx xxx nebo xxxxxxxx do 1. xxxxxxxxx 2004, xxxxx xxxxxx x xxxxxxx x xxxxx směrnicí, xxxxx xxx xxxxxxxxx xx xxxxxxxxx xxxxx.
Xxxxxx 4
Xxxx xxxxxxxx xxxxxxxx x platnost xxxxxxxx dnem po xxxxxxxxx v Xxxxxxx xxxxxxxx Xxxxxxxx xxxx.
Článek 5
Xxxx xxxxxxxx xx určena členským xxxxxx.
X Xxxxxxx xxx 27. října 2003.
Xx Xxxxxx
Xxxxx Xxxxx
xxxx Komise
[1] Úř. xxxx. X 40, 11.2.1989, x. 27.
[2] Úř. xxxx. X 237, 10.9.1994, x. 1.
[3] Xx. xxxx. X 61, 18.3.1995, x. 1.
[4] Úř. xxxx. X 55, 24.2.2001, x. 59.
[5] Xx. xxxx. X 339, 30.12.1996, x. 1.
[6] Xx. xxxx. X 292, 28.10.2002, x. 1.
XXXXXXX
Xxxxxxx xxxxxxxx 96/77/ES xx xxxx takto:
1. Xxxx xxxxxxxx xx xxxxx X 251 xxxxxxxx xxxxx se xxxxxxxxx xxxxx:
"X 251 XXXXXXXX XXXXX
1. XXXX XXXXXXXX XXXXX
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Xxxxxxxx |
Xxxxxxx xxxxx |
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Xxxxx xxxxx |
|
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Xxxxxxxx |
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Xxxxxxxx xxxxx |
Xxxxxxxx xxxxx |
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XXXXXX |
231-554-3 |
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Xxxxxxxx xxxxxx |
XxXX3 |
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Xxxxxxxxxx xxxxxxxx |
85,00 |
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Xxxxx |
Xxxxx ne xxxx xxx 99 % xx xxxxxx |
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Xxxxx |
Xxxx xxxxxxxxxxx, xxxxx hygroskopický xxxxxx |
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Xxxxxxxxxxxx |
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X. Xxxxxxxxx zkoušky xx xxxxxxxxxx dusičnanů x xxxxxx |
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X. xX 5 % xxxxxxx |
Xx xxxx xxx 5,5 x xx xxxx xxx 8,3 |
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Xxxxxxx |
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Xxxxxx hmotnosti xxxxxxx |
Xx xxxx xxx 2 % xx xxxxxxxxxxxxx sušení při 105 °C |
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Dusitany |
Ne více xxx 30 xx/xx xxxxxxxxx xxxx XxXX2 |
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Xxxxx |
Xx xxxx než 3 xx/xx |
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Xxxxx |
Xx více xxx 5 xx/xx |
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Xxxx |
Xx xxxx xxx 1 xx/xx |
X 251 XXXXXXXX XXXXX
2. XXXXXX XXXXXXXXX SODNÉHO
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Definice |
Roztok xxxxxxxxx xxxxxxx xx xxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxx chemickou xxxxxx hydroxidu xxxxxxx x xxxxxxxx xxxxxxx xx stechiometrickém xxxxxx xxx xxxxxxxx xxxxxxxxxxxx. Xxxxxxxxxxxxxxx formy xxxxxxxxxx x xxxxxxx dusičnanu xxxxxxx splňujícího xxxx xxxxxxxxxxx mohou xxxxxxxxx xxxxxxxx xxxxxxxx dusičné, xxxxx xx xxxx xxxxxxxxxx xxxxx xxxxxxx xxxx xx xxxxxxx xx štítku. |
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Chemický xxxxx |
Xxxxxxxx xxxxx |
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XXXXXX |
231-554-3 |
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Xxxxxxxx xxxxxx |
XxXX3 |
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Xxxxxxxxxx xxxxxxxx |
85,00 |
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Xxxxx |
Xxxxx XxXX3 xx 33,5 % do 40,0 % |
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Xxxxx |
Xxxx bezbarvý roztok |
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Identifikace |
|
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A. Xxxxxxxxx xxxxxxx xx xxxxxxxxxx xxxxxxxxx a xxxxxx |
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X. pH |
Ne xxxx xxx 1,5 x xx xxxx xxx 3,5 |
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Xxxxxxx |
|
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Xxxxx xxxxxxxx dusičná |
Ne xxxx než 0,01 % |
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Xxxxxxxx |
Xx xxxx než 10 xx/xx xxxxxxxxx xxxx XxXX2 |
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Xxxxx |
Xx xxxx xxx 1 mg/kg |
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Olovo |
Ne xxxx xxx 1 xx/xx |
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Xxxx |
Xx více než 0,3 xx/xx |
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Xxxx xxxxxxxxxxx xx xxxxxxxx xx 35 % xxxxx xxxxxx." |
2. Text xxxxxxxx xx látek E 431 xxxx(xxxxxxxxxx (40))xxxxxxx, X 432 xxxx(xxxxxxxxxx)xxxxxxxxxxxxxxxxxx (xxxxxxxxxx 20), X 433 xxxx(xxxxxxxxxx)xxxxxxxx-xxxxxxxxx (xxxxxxxxxx 80), E 434 xxxx(xxxxxxxxxx)xxxxxxxxxxxxxxxxxxxx (xxxxxxxxxx 40), X 435 xxxx(xxxxxxxxxx)xxxxxxxxxxxxxxxxxxx (xxxxxxxxxx 60) x X 436 xxxx(xxxxxxxxxx)xxxxxxxxxxxxxxxxxx (xxxxxxxxxx 65) xx xxxxxxxxx xxxxx:
"X 431 XXXX(XXXXXXXXXX (40))-XXXXXXX
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Xxxxxxxx |
Xxxxxxxx (40)-xxxxxxx |
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Xxxx(xxxxxxxxxx (40))xxxxxxxxxxx |
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Xxxxxxxx |
Xxxx xxxx x xxxxxxxx xxxxxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxx x xxxxxxx xxxx(xxxxxxxxxx)xxxxx (x xxxxxxxxx xxxxxx xxxxxxxx xxx 40 xxxxxxxxxxxxxxx xxxxxx) x xxxxxxx xxxxxxxxxxxx |
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Xxxxx |
Xxxxx xx xxxx xxx 97,5 %, xxxxxxxx na bezvodou xxxxx |
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Xxxxx |
Xxx 25 °X xxxxxxxxx xxxxxx xxxxxxx xxxxxxxx xxxxxx xxxx xxxxxxxxx xxxxx |
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Xxxxxxxxxxxx |
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X. Rozpustnost |
Rozpustná xx xxxx, xxxxxxxx, xxxxxxxxx x xxxxxxxxxxxx. Xxxxxxxxxxx v xxxxxxxxxx xxxxx |
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X. Rozmezí bodu xxxxxxx |
39 °C – 44 °X |
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X.Xxxxxxxxxxxx xxxxxxxxx xxxxxxxx |
Xxxxxxxxxxxxxxxx xxx xxxxxxxxx xxxxx xxxxxxxxxxxxxxxxxxx polyalkoholu x xxxxxxx xxxxxxxxx |
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Xxxxxxx |
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Xxxxx xxxx |
Xx xxxx xxx 3 % (Xxxx-Xxxxxxxxxx xxxxxx) |
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Xxxxx xxxxxxxxx |
Xx xxxx xxx 1 |
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Číslo xxxxxxxxxx |
Xx xxxx xxx 25 x xx více xxx 35 |
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Xxxxxxxxxxx xxxxx |
Xx xxxx než 27 x xx xxxx xxx 40 |
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1,4-Dioxan |
Ne xxxx xxx 5 xx/xx |
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Xxxxxx |
Xx xxxx xxx 0,2 xx/xx |
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Xxxxxxxxxxxxxx (xxxx x xx) |
Xx xxxx xxx 0,25 % |
|
Xxxxx |
Xx xxxx xxx 3 mg/kg |
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Olovo |
Ne xxxx než 5 xx/xx |
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Xxxx |
Xx xxxx než 1 mg/kg |
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Kadmium |
Ne xxxx xxx 1 mg/kg |
E 432 POLY(OXYETHYLEN)-SORBITAN-MONOLAURÁT (XXXXXXXXXX 20)
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Xxxxxxxx |
Xxxxxxxxxx 20 |
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Xxxx(xxxxxxxxxx (20))-xxxxxxxx-xxxxxxxxxx |
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Xxxxxxxx |
Xxxx xxxxxxxxxxx esterů sorbitolu x xxxx xxxx x xxxxxxxxxxx s xxxxxxxx potravinářskou laurovou xxxxxxxxx, kondenzovaných x xxxxxxxxx 20 xxxx xxxxxxx xx xxx xxxxxxxxx a jeho xxxxxxxxx |
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Xxxxx |
Xxxxx ne xxxx xxx 70 % xxxxxxxxxxxxxxx xxxxxx; xxxxxxxx xx xxxx xxx 97,3 % xxxx(xxxxxxxxxx (20))-xxxxxxxx-xxxxxxxxxxx, xxxxxxxx na xxxxxxxx xxxxx |
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Xxxxx |
Xxx 25 °X citrónově xx xxxxxxxxx zbarvená olejovitá xxxxxxxx s nevýraznou xxxxxxxxxxxxxxxxx xxxx |
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Xxxxxxxxxxxx |
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X. Xxxxxxxxxxx |
Xxxxxxxxx xx vodě, xxxxxxxx, xxxxxxxxx, ethylacetátu x xxxxxxx. Nerozpustná v xxxxxxxxxx oleji x xxxxxxxxxxxx |
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X. Xxxxxxxxxxxx absorpční xxxxxxxx |
Xxxxxxxxxxxxxxxx xxx xxxxxxxxx xxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxx x xxxxxxx kyselinou |
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Čistota |
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Voda |
Ne xxxx xxx 3 % (Xxxx-Xxxxxxxxxx xxxxxx) |
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Xxxxx xxxxxxxxx |
Xx více než 2 |
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Xxxxx xxxxxxxxxx |
Xx méně xxx 40 x xx xxxx xxx 50 |
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Xxxxxxxxxxx xxxxx |
Xx méně xxx 96 a xx xxxx xxx 108 |
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1,4Xxxxxx |
Xx xxxx xxx 5 xx/xx |
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Xxxxxx |
Xx více xxx 0,2 xx/xx |
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Xxxxxxxxxxxxxx (xxxx x di) |
Ne xxxx xxx 0,25 % |
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Xxxxx |
Xx xxxx xxx 3 xx/xx |
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Xxxxx |
Xx více xxx 5 xx/xx |
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Xxxx |
Xx xxxx xxx 1 xx/xx |
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Xxxxxxx |
Xx xxxx než 1 xx/xx |
X 433 XXXX(XXXXXXXXXX)-XXXXXXXX-XXXXXXXXX (XXXXXXXXXX 80)
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Synonyma |
Polysorbát 80 |
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Xxxx(xxxxxxxxxx (20))-sorbitan-monooleát |
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Definice |
Směs xxxxxxxxxxx xxxxxx xxxxxxxxx x xxxx xxxx a xxxxxxxxxxx x xxxxxxxx xxxxxxxxxxxxxx olejovou xxxxxxxxx, xxxxxxxxxxxxxx x xxxxxxxxx 20 moly xxxxxxx xx xxx xxxxxxxxx x jeho xxxxxxxxx |
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Xxxxx |
Xxxxx xx méně než 65 % oxyethylenových xxxxxx; xxxxxxxx xx xxxx než 96,5 % xxxx(xxxxxxxxxx (20))-sorbitan-monooleátu, xxxxxxxx na xxxxxxxx xxxxx |
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Xxxxx |
Xxx 25 °X xxxxxxxxx xx xxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxx x xxxxxxxxxx xxxxxxxxxxxxxxxxx xxxx |
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Xxxxxxxxxxxx |
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X. Xxxxxxxxxxx |
Xxxxxxxxx xx xxxx, xxxxxxxx, methanolu, xxxxxxxxxxxx x toluenu. Xxxxxxxxxxx v minerálním xxxxx x petroletheru |
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B. Xxxxxxxxxxxx xxxxxxxxx spektrum |
Charakteristické xxx parciální xxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxx s xxxxxxx kyselinou |
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Čistota |
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Obsah vody |
Ne xxxx xxx 3 % (Xxxx-Xxxxxxxxxx xxxxxx) |
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Xxxxx xxxxxxxxx |
Xx xxxx xxx 2 |
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Xxxxx xxxxxxxxxx |
Xx méně xxx 45 a xx xxxx xxx 55 |
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Xxxxxxxxxxx xxxxx |
Xx méně xxx 65 a xx xxxx než 80 |
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1,4-Xxxxxx |
Xx více než 5 xx/xx |
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Xxxxxx |
Xx xxxx xxx 0,2 mg/kg |
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Ethylenglykoly (xxxx a xx) |
Xx xxxx xxx 0,25 % |
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Xxxxx |
Xx xxxx než 3 mg/kg |
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Olovo |
Ne xxxx xxx 5 mg/kg |
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Rtuť |
Ne xxxx xxx 1 xx/xx |
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Xxxxxxx |
Xx xxxx než 1 xx/xx |
X 434 XXXX(XXXXXXXXXX)-XXXXXXXX-XXXXXXXXXXXX (POLYSORBÁT 40)
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Xxxxxxxx |
Xxxxxxxxxx 40 |
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Xxxx(xxxxxxxxxx (20))-sorbitan-monopalmitát |
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Definice |
Směs parciálních xxxxxx sorbitolu a xxxx xxxx a xxxxxxxxxxx x komerční xxxxxxxxxxxxxx xxxxxxxxxx kyselinou, xxxxxxxxxxxxxx x xxxxxxxxx 20 moly oxiranu xx xxx xxxxxxxxx x xxxx xxxxxxxxx |
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Xxxxx |
Xxxxx xx méně xxx 66 % xxxxxxxxxxxxxxx xxxxxx; xxxxxxxx ne xxxx xxx 97 % xxxx(xxxxxxxxxxx (20))-xxxxxxxx-xxxxxxxxxxxxx, xxxxxxxx xx xxxxxxxx xxxxx |
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Xxxxx |
Xxx 25 °C xxxxxxxxx xx oranžově xxxxxxxx xxxxxxxxx xx xxxxxxxx xxxxxxxx x xxxxxxxxxx xxxxxxxxxxxxxxxxx xxxx |
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Xxxxxxxxxxxx |
|
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X. Xxxxxxxxxxx |
Xxxxxxxxx ve vodě, xxxxxxxx, xxxxxxxxx, ethylacetátu x xxxxxxx. Xxxxxxxxxxx x xxxxxxxxxx oleji |
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B. Xxxxxxxxxxxx xxxxxxxxx xxxxxxxx |
Xxxxxxxxxxxxxxxx xxx xxxxxxxxx xxxxx xxxxxxxxxxxxxxxxxxx polyalkoholu s xxxxxxx xxxxxxxxx |
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Xxxxxxx |
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Xxxxx vody |
Ne xxxx xxx 3 % (Karl-Fischerova metoda) |
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Číslo xxxxxxxxx |
Xx více xxx 2 |
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Xxxxx xxxxxxxxxx |
Xx xxxx xxx 41 x xx xxxx než 52 |
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Xxxxxxxxxxx xxxxx |
Xx xxxx xxx 90 x xx xxxx než 107 |
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1,4-Xxxxxx |
Xx více než 5 xx/xx |
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Xxxxxx |
Xx xxxx xxx 0,2 xx/xx |
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Xxxxxxxxxxxxxx (xxxx a xx) |
Xx xxxx xxx 0,25 % |
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Xxxxx |
Xx xxxx xxx 3 xx/xx |
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Xxxxx |
Xx xxxx xxx 5 mg/kg |
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Rtuť |
Ne xxxx xxx 1 xx/xx |
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Xxxxxxx |
Xx xxxx xxx 1 xx/xx |
X 435 XXXX(XXXXXXXXXX)-XXXXXXXX-XXXXXXXXXXX (POLYSORBÁT 60)
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Xxxxxxxx |
Xxxxxxxxxx 60 |
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Xxxx(xxxxxxxxxx (20))-sorbitan-monostearát |
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Definice |
Směs parciálních xxxxxx xxxxxxxxx a xxxx mono a xxxxxxxxxxx x xxxxxxxx xxxxxxxxxxxxxx xxxxxxxxx xxxxxxxxx, xxxxxxxxxxxxxx x xxxxxxxxx 20 moly xxxxxxx xx xxx sorbitolu x xxxx xxxxxxxxx |
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Xxxxx |
Xxxxx xx xxxx xxx 65 % xxxxxxxxxxxxxxx xxxxxx; xxxxxxxx xx xxxx xxx 97 % poly(oxyethylen (20))-xxxxxxxxxxxxxxxxxxxx, xxxxxxxx na xxxxxxxx xxxxx |
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Xxxxx |
Xxx 25 °C xxxxxxxxx xx xxxxxxxx xxxxxxxx olejovitá xx xxxxxxxx xxxxxxxx x xxxxxxxxxx charakteristickou xxxx |
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Xxxxxxxxxxxx |
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X. Xxxxxxxxxxx |
Xxxxxxxxx ve vodě, xxxxxxxxxxxx x xxxxxxx. Xxxxxxxxxxx x minerálním xxxxx a v xxxxxxxxxxx olejích |
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B. Xxxxxxxxxxxx xxxxxxxxx spektrum |
Charakteristické xxx xxxxxxxxx xxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxx s xxxxxxx xxxxxxxxx |
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Xxxxxxx |
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Xxxxx xxxx |
Xx xxxx xxx 3 % (Xxxx-Xxxxxxxxxx metoda) |
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Číslo xxxxxxxxx |
Xx xxxx xxx 2 |
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Xxxxx xxxxxxxxxx |
Xx xxxx xxx 45 x ne xxxx než 55 |
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Hydroxylové xxxxx |
Xx xxxx xxx 81 x xx xxxx xxx 96 |
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1,4-Xxxxxx |
Xx xxxx xxx 5 xx/xx |
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Xxxxxx |
Xx více xxx 0,2 xx/xx |
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Xxxxxxxxxxxxxx (xxxx x xx) |
Xx xxxx xxx 0,25 % |
|
Xxxxx |
Xx xxxx než 3 xx/xx |
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Xxxxx |
Xx xxxx xxx 5 xx/xx |
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Xxxx |
Xx xxxx xxx 1 xx/xx |
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Xxxxxxx |
Xx xxxx xxx 1 xx/xx |
X 436 POLY(OXYETHYLEN)-SORBITAN-TRISTEARÁT (XXXXXXXXXX 65)
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Xxxxxxxx |
Xxxxxxxxxx 65 |
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Xxxx(xxxxxxxxxx (20))-xxxxxxxx-xxxxxxxxxx |
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Xxxxxxxx |
Xxxx parciálních esterů xxxxxxxxx x xxxx xxxx a dianhydridů x komerční xxxxxxxxxxxxxx xxxxxxxxx kyselinou, kondenzovaných x přibližně 20 xxxx xxxxxxx xx xxx xxxxxxxxx x xxxx xxxxxxxxx |
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Xxxxx |
Xxxxx xx xxxx xxx 46 % xxxxxxxxxxxxxxx skupin; xxxxxxxx xx méně xxx 96 % xxxx(xxxxxxxxxx (20)-sorbitantristearátu, xxxxxxxx xx xxxxxxxx xxxxx |
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Xxxxx |
Xxx 25 °C xxxxxxxxxx xxxxxxxxx hmota s xxxxxxxxxx xxxxxxxxxxxxxxxxx xxxx |
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Xxxxxxxxxxxx |
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X. Xxxxxxxxxxx |
Xxxxxxxxxxxxxxx xx xxxx. Xxxxxxxxx x xxxxxxxxxx xxxxx a x xxxxxxxxxxx olejích, xxxxxxxxxxxx, xxxxxxx, xxxxxxxxxxxxx, dioxanu, xxxxxxxx a xxxxxxxxx |
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X. Xxxxxxx bodu xxxxxxx |
29 – 33 °X |
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X. Xxxxxxxxxxxx xxxxxxxxx xxxxxxxx |
Xxxxxxxxxxxxxxxx xxx xxxxxxxxx xxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxx x xxxxxxx kyselinou |
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Čistota |
|
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Obsah xxxx |
Xx xxxx xxx 3 % (Xxxx-Xxxxxxxxxx metoda) |
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Číslo xxxxxxxxx |
Xx xxxx xxx 2 |
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Xxxxx zmýdelnění |
Ne xxxx xxx 88 x xx více než 98 |
|
Xxxxxxxxxxx číslo |
Ne xxxx xxx 40 a xx xxxx xxx 60 |
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1,4-Xxxxxx |
Xx xxxx xxx 5 mg/kg |
|
Oxiran |
Ne xxxx xxx 0,2 mg/kg |
|
Ethylenglykoly (xxxx x xx) |
Xx xxxx xxx 0,25 % |
|
Xxxxx |
Xx xxxx xxx 3 xx/xx |
|
Xxxxx |
Xx xxxx xxx 5 xx/xx |
|
Xxxx |
Xx xxxx xxx 1 xx/xx |
|
Xxxxxxx |
Xx více než 1 xx/xx" |
3. Xxxx xxxxxxxx xx xxxxx X 459 βcyklodextrin xx xxxxxxxxx xxxxx:
"X 459 ΒCYKLODEXTRIN
|
Definice |
βCyklodextrin xx xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xx xx xxxxx α-Xxxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxx (1 → 4). Xxxxxxx se xxxxxxx xxxxxxxxx xxxxxx xxxxxxxxxxxxxxxxxxxxxxxx (CGTasy) získané x Xxxxxxxx xxxxxxxxx, Xxxxxxxxxxxxx macerans xxxx xxxxxxxxxxxx Bacillus xxxxxxxxxxxxx, xxxx SJ1608, na xxxxxxxx xxxxxxxxxxxxx xxxxx |
|
Xxxxxxxx xxxxx |
Xxxxxxxxxxxxxxxxxx |
|
XXXXXX |
2314932 |
|
Xxxxxxxx vzorec |
(C6H10O5)7 |
|
Molekulová xxxxxxxx |
1135 |
|
Xxxxx |
Xxxxx xx xxxx než 98,0 % (X6X10X5)7, xxxxxxxx xx bezvodou xxxxx |
|
Xxxxx |
Xxxx nebo xxxxx xxxx xxxxxxxxxxx xxxxx, xxxxxxxxx bez zápachu |
|
Identifikace |
|
|
A. Xxxxxxxxxxx |
Xxxxx xxxxxxxxx ve xxxx; snadno xxxxxxxxx x horké vodě; xxxx rozpustná x xxxxxxxx |
|
X. Xxxxxxxxxx xxxxxx: |
[α]25X : +160o až + 164x (1 % xxxxxx) |
|
Xxxxxxx |
|
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Xxxxx xxxx |
Xx xxxx než 14 % (Karl-Fischerova xxxxxx) |
|
Xxxx xxxxxxxxxxxxx |
Xx xxxx xxx 2 %, vztaženo xx bezvodou látku |
|
Zbytková xxxxxxxxxxxx (xxxxxx x xxxxxxxxxxxxxxx) |
Xx xxxx než 1 mg/kg každého x xxxxxxxxxxxx |
|
Xxxxxxxx popel |
Ne xxxx než 0,1 % |
|
Xxxxx |
Xx xxxx než 1 mg/kg |
|
Olovo |
Ne xxxx xxx 1 mg/kg" |
4. Xxxx xxxxxxxx xx xxxx(xxxxxxxxxxxxxx) 6000 xx xxxxxxxxx tímto:
"POLY(ETHYLENGLYKOL) 6000
|
Xxxxxxxx |
XXX 6000 |
|
Xxxxxxxx 6000 |
|
|
Definice |
Polyethylenglykol 6000 xx xxxx polymerů x xxxxxxx vzorcem X(XXX2XX2)xXX x xxxxxxxxx xxxxxxxxx xxxxxxxxxxx xxxxxxxxx 6000 |
|
Xxxxxxxx xxxxxx |
(X2X4X)x H2O (x = xxxxx xxxxxxxxxxxxxxx xxxxxxxx odpovídající xxxxxxxxxx xxxxxxxxx 6000, xx. xxx 140) |
|
Xxxxxxxxxx xxxxxxxx |
5600 – 7000 |
|
Obsah |
Ne xxxx xxx 90,0 % x xx xxxx než 110,0 % |
|
Xxxxx |
Xxxx nebo téměř xxxx tuhá látka xxxxxxxxxxx xxxx xxxxxxxxxxxx xxxxxxx |
|
Xxxxxxxxxxxx |
|
|
X. Rozpustnost |
Velmi xxxxxx xxxxxxxxx ve xxxx x v xxxxxxxxxxxxxx. Xxxxx nerozpustný x xxxxxxxx, xxxxxx a x xxxxxxxx x xxxxxxxxxxx xxxxxxx |
|
X. Xxxxxxx xxxx xxxx |
Xx 55 °X do 61 °X |
|
Xxxxxxx |
|
|
Xxxxxxxxx |
Xx 0,220 xx 0,275 xx x-1x-1 xxx 20 °C |
|
Hydroxylové xxxxx |
Xx 16 do 22 |
|
Xxxxxxxx xxxxx |
Xx xxxx xxx 0,2 % |
|
Oxiran |
Ne xxxx xxx 0,2 xx/xx |
|
Xxxxx |
Xx xxxx xxx 3 mg/kg |
|
Olovo |
Ne xxxx xxx 5 xx/xx" |