XXXXXXXX XXXXXX X XXXXXXXXX XXXXXXXXX (XX) x. 1062/2014
xx dne 4. xxxxx 2014,
týkající xx xxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxx x xxxxxxxxxx xxxxxxxxxxx, xxxxx xxxx xxxxxxx x xxxxxxxx Evropského parlamentu x Xxxx (XX) x. 528/2012
(Xxxx x xxxxxxxx xxx XXX)
XXXXXXXX KOMISE,
s ohledem na Xxxxxxx x xxxxxxxxx Evropské xxxx,
x ohledem xx xxxxxxxx Evropského xxxxxxxxxx x Xxxx (XX) x. 528/2012 xx xxx 22. xxxxxx 2012 x xxxxxxxx xxxxxxxxxx přípravků na xxx x jejich xxxxxxxxx (1), a zejména xx xx. 89 xxxx. 1 první xxxxxxxxxxx xxxxxxxxx xxxxxxxx,
xxxxxxxx x xxxxx důvodům:
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(1) |
Xxxxxxxx Xxxxxx (XX) x. 1451/2007 (2) xxxxxxx prováděcí pravidla xxx program přezkumu xxxxxxxxxxx xxxxxxxxxx účinných xxxxx (dále jen „xxxxxxx xxxxxxxx“), který xxx zahájen v souladu x xx. 16 xxxx. 2 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx 98/8/XX (3). Protože tato xxxxxxxx byla xxxxxxx x xxxxxxxxx xxxxxxxxx (EU) x. 528/2012, xxxx xx xxx xxxxxxxxx xxxxxxxx xxx xxxxxxxxxxx programu xxxxxxxx přizpůsobena xxxxxxxxxxx xxxxxxxxx xxxxxxxx. |
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(2) |
Je xxxxxxxx xxxxx xxxxxxxxx účinné xxxxx x xxxx xxxxxxxxx, xxxxx mohou xxx xxxxxxxx na trh x xxxxxxxxx xxxxx přechodných xxxxxxxxxx xxxxxx 89 xxxxxxxx (XX) č. 528/2012 x xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx. Mělo xx tomu xxx x x xxxxxxx xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx, xxxxx xxxx xxxxxxxxx x programu přezkumu. |
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(3) |
Pokud xxxxxxxxx xxxxxxxx xxxxxxxx xxx potraviny x xxxxxx xxxxx xxxxxx 6 xxxxxxxx (ES) x. 1451/2007, xxx xxxxxxxxxx xx xx xxx xxxxxxx xxx xxxxxxxxx x xxxxxx xxxxxxx x xx. 2 odst. 5 xxxx. x) xxxxxxxx (XX) x. 528/2012, xxxx by xxx xxxxxx xxxxx, xxxxx obsahuje, xxxxxxxxx x xxxxxxxx přezkumu xxx xxxxxxxxx xxx xxxxxxxxx. X xxxxxxxx xxxxxxxxxxxxxx předpisů xx xxxx xxx xxxxxx xxxxxxxx xx xxx x xxxxxxxxx xxxxxxxx až xx xxxxxxxx xxxxxxxxx xxxxxxxxx. Xxxxxx xxxxxxxxxxx xxxxxxxxxx xx měl vymezit, xxxxx přípravky tohoto xxxxxxxxxx xxxxxxx. Xxxxx xx xxxx platit x xxxxxxxxx, xxx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx vyplynulo x nové xxxxxxxx xxxx přípravků x xxxxxxxx (XX) x. 528/2012 xxxxxx xxxxxxxx uvedené xx xxxxxxxx 98/8/XX xxxx xx řádně odůvodněno xxxxxxxxxxx Xxxxxx xxxxxxxx x xxxxxxx x xx. 3 odst. 3 xxxxxxxx (EU) x. 528/2012, xxxxxxxxxxx (xxxxxxxxx xxxxxxxxxxx xx xxxx X-420/10 (4)) xxxx závaznými xxxxxx Xxxxxx či příslušných xxxxxx xxxxxxxxx xxxxx, xxxxx xx následně xxxxxxx. |
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(4) |
Xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxx xxxxx, xxxxx xxx není xxxxxxxx xx programu xxxxxxxx, x této xxxxx sestává nebo xx x ní xxxxxx, xxxxx současně xx xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxx v členském xxxxx xxxxxxxx, xxxx xx xxx v tomto xxxxxxxx xxxxx xxxxxxx x dodávání xx xxx xxxxxxxx xx jeho xxxxxxxxxxxx, xx určitých xxxxxxxx a po xxxxxxxx xxxx. |
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(5) |
X zájmu jednotnosti x xxxxxxxxxxxx xx xxx xxx postup xxxxxxxxx xxxxxxxx látek v programu xxxxxxxx xx xxxxx xxxxxxxxxx xxxxxxx xxxxxxx x xxxxxxxx stanoveným xxx žádosti xxxxxxxxxx xxxxx xxxxxx 7 xxxxxxxx (XX) x. 528/2012 xxxx xxxxx xxxxxxxxxxx xxxxxxxx Xxxxxx (XX) x. 88/2014 (5). |
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(6) |
Xxx xxxxx, které splňují xxxxxxxx xxxxxxxxx xxxx xxxxxxxx pro náhradu, xx xxx xxxxxxxxx xxxxxxxxx xxxxx předložit xxxxxxxx návrh xxxxxxxxxxxxx xxxxxxxxxxx a označení xxxxx xxxxx xx. 37 odst. 1 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (ES) č. 1272/2008 (6), xxxxx jde x xxxxxxxxx xxxxxxxxxx vzbuzující xxxxx, a zároveň by xxxx být xxxxxxxxx xxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx xxxxxxxx xx xxxxxx xxxx xxxxx xxxxxxxxxxx xxxxxxxxxx. Xxxxxxxxx xxxxxxxxx orgán xx měl také xxxxxxxxxxx xxxxxxxx x xxxxxxx xxxxx, xxxxx xx splňovaly xxxxxxxx xxx látky xxxxxxxxxxxx, xxxxxxxxxxxxxxx xx xxxxxxx, xxxx xxxxx, xxxxx by xxxxx xxx xxxxxxxxxx xx xxxxx x xxxxxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxx. |
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(7) |
Xxx xxxx zajištěno, xx xxxxxxx přezkumu xxxx xxxxxxxx xx xxxxxxxx data uvedeného x xx. 89 xxxx. 1 xxxxxxxx (XX) x. 528/2012, xxxx xx se xxxxxxxxx xxxxxx xx xxxxxxxxx xxxxxx xxxxx a typu xxxxxxxxx, u xxxxx xxxx xxxxxxxxx xxxxx xxxxxxxxxx xx xxxxxxx stanovených x xxxxxxxx (XX) č. 1451/2007 xxxx x xxxxx xxxxxxxx. Xxxxx xxxx xx xx xxxx xxxxxxxx xxxxxx xxxxx xxx xxxxxxxxx xxxxxxxxx, xxxxxxx xx xx xxxx xxxx v xxxxx xxxxxxx, že žádosti xx xxxxx xxx xxxxxxxxx xxxx než xxx xxxx xxxxxxxxx xxxxxx lhůt. |
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(8) |
Xxxxxxx xxxxxxxx xx přílohy I xxxxxxxxx 7 nařízení (XX) x. 528/2012 xxxxx xxxxxx xxxxxxxxx žádné xxxxxxxxx na xxxxx. Xx proto xxxxxx x xxxx fázi xxxxxx žádosti o zařazení xx uvedené přílohy xx kategorie 1, 2, 3, 4, 5 xxxx 6. |
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(9) |
Bez xxxxxx na čl. 90 odst. 2 xxxxxxxx (XX) x. 528/2012 xxxxxxx x xxxxxx 91 xxxxxxxxx nařízení, xx xxxxxxxx xxxxxxx v článku 10 xxxxxxxxx xxxxxxxx by xxxx xxx relevantní xxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx přípravků ve všech xxxxxxxxx. Xx xxxxx xxxxxx xxxxx xxxxx xxxxxxxxx tato xxxxxxxx xx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx. |
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(10) |
Xxxxxxxxxxx účastník xxxxxxxx xxxxxxxx xx xxx xxx možnost xx xx vzájemné xxxxxx xxxxxxxx xx stávajícímu xxxxxxxxxxx nebo jej xxxxxxxx za předpokladu, xx kvůli xxxx xxxxxxx xx zpoždění xxxxxxxxx x xxxxxx xxxxxxxxx xxxxxxxx x xxxxxx, xxxxxxx jinak xx xxxxxxxxxxx účastník xxxxx xxxxxxxxx xxxxx xxxxx. |
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(11) |
Xxxxxxx xx xxxxx x xxxxxxxx xxxxxxxx dobrovolná, xxxx xx xxx xxxxxxxxxx xxxxxxxx xx ní xxxxxxxxx. Xxxxx x xxxx dojde, měli xx xxx xxxxxxxxxxx xxxxxxxxx xxxxxxx xxxxxxx xxxxxxx, nebylo-li xxxx xxxxxxxx využito xxx xxxxxx, xxxxx tím xxxxxxx xx zpoždění xxxxxxxx xxxxxxxx, x xxxxxxxx-xx xxxxxxxx již xxxxxxxx na xxxx xxxxxxxxxx. |
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(12) |
Xxxxx se při xxxxxxxxx xxxxxx xxxxx xxxxx, že identita xxxxxxxxx xxxxxxxx xx xxxxxxxx přezkumu xxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx xxxxx, x x xxxxxxxxx xxxxx xxxxxxx xxxxxx ohledně xxxxxxxx xxxxxxxxx zařazené xxxxx, mělo xx xxx xxxxx xxxx xxxxx x xxxxxxx xxxxxxxxx xxxxx xxxxxxxxx x xxxxxxx xxxxx xxxxxx, aby xxxxxxxx xxxxxxx xxxx xxxxxxxxx xxxxxxxx xxxxx. |
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(13) |
Xxxxxxx xxxxx xxxxxxxx do xxxxxxxx xxxxxxxx xxxxxx x xxxx xxxxxxx xxxxxx nařízení podporovány xxxxxx xxxxxxxxxx. Totéž xx xxxx xxxxxxxx xxxxxxxxxxxxx, xxxxxx xxxxx xx. 4 xxxx. 4 nařízení (XX) x. 528/2012 xxxx xxxxxxxxx xxxxx schválit, xxxxx tak není xxxxxxxx xxxxxxxxx. X xxxxxxxxx xxxxx a xxxxxxxxxxxxx xx xxxx xxx xxxxx xxxxxxx xxxxxxx xxxxx, xxxxxxx xxxxx xx xxxx xxxxx x xxxxxxxxxxxxx xxxxxx xxx z xxxxxxxx xxxxxxxx xxxxxxxxx. |
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(14) |
Xxx xxxx xxxxxxxxx, že xxxxx xxxxx xxxxxxxxx x xxxxxxxx neoprávněně ani xx xxx xxxxxx xxxxxxxx, aniž by xxxxxxxx xxxx xxxxxxxxxxx, xxxx by xxxxxxxx xxxxx, xxxxx ještě xxxxxx xxxxxxxxx, v xxxxxxxx nebo xxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxx x xx, |
XXXXXXX XXXX XXXXXXXX:
KAPITOLA 1
XXXXXXX X XXXXXXXX
Xxxxxx 1
Xxxxxxx
Xxxx xxxxxxxx xxxxxxx xxxxxxxx pro xxxxxxxxx pracovního xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx všech xxxxxxxxxxx xxxxxxxx látek xxxxxxxxx x&xxxx;xxxxxx&xxxx;89 xxxxxxxx (XX) x.&xxxx;528/2012.
Xxxxxx 2
Xxxxxxxx
Xxx účely xxxxxx xxxxxxxx se xxxxxxx xxxx definice:
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x) |
„rozhodnutím x neschválení“ se xxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxx čl. 9 xxxx. 1 xxxx. x) xxxxxxxx (XX) x. 528/2012 nebo xx. 89 xxxx. 1 xxxxxxx xxxxxxxxxxx uvedeného nařízení, xxxx xxxxxxxxx xxxxxxxxx xx xxxxxxx X xxxx IA xxxxxxxx 98/8/ES; |
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x) |
„xxxxxxxxx látky x xxxx xxxxxxxxx zařazenou xx xxxxxxxx xxxxxxxx“ se xxxxxx kombinace xxxxx x xxxx přípravku xxxxxxx x xxxxxxx XX, xxxxx xxxxxxx tyto xxxxxxxx:
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c) |
„xxxxxxxxxx“ xx xxxxxx osoba, xxxxx xxxxxxxxxx xxxxxx x xxxxxxxxx xxxxx x xxxx xxxxxxxxx zařazené do programu xxxxxxxx xxxx xxxxxxxxxx xxxxxxxx, xxxxx odpovídá xxxxxxxxxx podle xx. 17 xxxx. 5 xxxxxx xxxxxxxx, xxxx xxxxxx xxxxxx xxxx tato xxxxxx xxxx xxxxxxxx xxxxxxxxxx; |
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x) |
„xxxxxxxxxx xxxxxxxxxx xxxxxxx“ xx xxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx xxxxxxxxx x xxxxxxx XX xxxxxx xxxxxxxx, xxxxxx x xxxxxxx x xxxxxxx 81 nařízení (XX) č. 528/2012. |
XXXXXXXX 2
XXXXXX HODNOCENÍ XXXXXXXXXXX
Xxxxxx 3
Xxxxxx x xxxxxxxxx nebo xxxxxxxx xx xxxxxxx I xxxxxxxx (XX) x. 528/2012
1.&xxxx;&xxxx;&xxxx;Xxxxxx o schválení či xxxxxxxx xx&xxxx;xxxxxxx X&xxxx;xxxxxxxx (XX) x.&xxxx;528/2012 xxxx xxxxx xxxxx xxxxxxxx, x xxxxx xxxxxxxx xxxxx agentura k xxxxxx, xx xxxxxxxx xxxxxxxxxx xxxxx čl. 17 xxxx.&xxxx;5 xxxxxx xxxxxxxx.
Xxxxx xx žádost xxxx xxxxxxxx xx&xxxx;xxxxxxx X&xxxx;xxxxxxxx (XX) č. 528/2012, xxxx xx týkat xxxxx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx xxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxxxxx x&xxxx;xxxxxxxx 1 xx xxxxxxxx xxxxxxxx do dvou xxx xx xxxxxxxxxx x&xxxx;xxxxxxx x xxxxxxxxx podle xx.&xxxx;17 xxxx.&xxxx;5.
Xxxxxx 4
Xxxxxxx xxxxxxx
1. Xxxxxxxx xxxxxxxxx účastníka x xxxxxxxx xxxxxxxx podle xxxxxxxxxxx xxxxxxxx Komise (XX) x. 564/2013 (7) x xxxxxxx žádost, xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxx 30 xxx. X xxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx i xxxxxxxxx xxxxxxxxx xxxxx.
2. Xx xxxxxxxx xxxxxxxx xxxxxxxxx podle xxxxxxxxxxx nařízení (XX) x. 564/2013 xxxxxx xxxxxxxx žádost a informuje x xxx účastníka x xxxxxxxxx xxxxxxxxx xxxxx, xxxxxxx uvede datum xxxxxxx žádosti a její xxxxxxxxx identifikační kód.
3. Xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 1 xxxxxx xxxxxx lze podat xxxxxxx xxxxxxxxxx v xxxxxxx s článkem 77 nařízení (XX) x. 528/2012.
4. Xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx účastníka x xxxxxxxx xxxxxxxx xxxxx xx. 80 xxxx. 2 xxxxxxxx (XX) č. 528/2012 xx 30 xxx xxxx, xx agentura xxxxxxx xxxxxx, x xxxxxxx xxxxxx, pokud xxxxxxxx xxxxxxxxx poplatek xx xxxxx 30 xxx. X této xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxx.
Xxxxxx 5
Potvrzení xxxxxxx x xxxxxxxxx xxxx xxxxxxxx xx kategorie 6 přílohy X xxxxxxxx (EU) x. 528/2012
1. Xxxxx xxxxxxxx xxxxxx xxxxx xx. 4 xxxx. 2 xxxxxx x xxxxxxxxx nebo zařazení xx xxxxxxxxx 6 přílohy X xxxxxxxx (XX) x. 528/2012, xxxxx xxxxxxxx xxxxx xxxxxxxxxx x xxxxxxx x xx. 6 xxxx. 1 x 2 xxxxxxxxx nařízení, a byl xxxxxxxx xxxxxxxx xxxxx xx. 4 odst. 4, hodnotící xxxxxxxxx orgán žádost xxxxxxx do 30 xxx xx xxxxxxxxx poplatků.
2. Xxxxx xxxxxxxxx xxxxxxxxx orgán xxxxxxx xx xxxxxxxxx dokumentaci xxxxx xxxxxxxx (ES) x. 1451/2007, xxxxx ta xxxxx xxxxxx uznána xxxx úplná podle xxxxxx 13 uvedeného xxxxxxxx, xxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxx xxxxxxxxxx xx 3. ledna 2015.
3. X případech xxxxxxxxx x odstavcích 1 x 2 hodnotící xxxxxxxxx orgán xxxxxxxxx xxxxxxxxx xxxxxxx ani xxxxxxxxxxxx xxxxxxxxxxxx xxxxx xxxx odůvodnění.
4. Xxxxx xxxxxxxxx xxxxxxxxx xxxxx usoudí, xx xxxxxx xx xxxxxxx, xxxxx xxxxxxxxxxx, xxxx xxxxxxxxxx informace xxxx x potvrzení xxxxxxx xxxxx, a x xxxxxxxxxx těchto xxxxxxxxx stanoví přiměřenou xxxxx. Xxxx lhůta xxxxx xxxxxxxxxx 90 dnů.
Xxxxxxxx-xx xxxxxxxxx xxxxxxxxx xxxxx, xx xxxxxxxxxx doplňující xxxxxxxxx xxxxxxxxx xx xxxxxxx xxxxxxxxx uvedených x odstavci 2, xxxxxxx žádost xx 30 xxx xx xxxxxxxx xxxxxxxxxxxx xxxxxxxxx.
Xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxxxxxxxx xxxxx xxxxxxxxxx, xxxxxxxxx příslušný xxxxx xxxxxx zamítne x xxxxxxxxx o xxxx xxxxxxxxxxx účastníka x xxxxxxxx. X xxxxxx xxxxxxxxx xx xxxxx xxxxxxxx xxxxxxxxx x xxxxxxx s čl. 80 odst. 1 x 2 nařízení (XX) x. 528/2012.
Xxx xxxxxxxxx žádosti xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxxx xxxxxxxxx účastníka, xxxxxxxx x xxxxx xxxxxxxxx xxxxxx a uvede datum xxxxxx potvrzení.
Xxxxxx 6
Xxxxxxxxx žádostí
1. Xxxxx xxxxxx se xxxxxxx, xxxxx xxxxx některá x xxxxxx xxxxxxxx:
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x) |
xx-xx xxxxxx xxxxxxxxx xxxxx xxxxxx 5; |
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x) |
xxxxx hodnotící xxxxxxxxx xxxxx xxxxx xxxxxxxxxxx xxxx xxxxxx xxxxx xxxxxx 13 xxxxxxxx (XX) x. 1451/2007, ale xxxxx xxxxxxxxxxx Komisi zprávu xxxxxxxxxxx xxxxxx podle xx. 14 xxxx. 4 xxxxxxxxx xxxxxxxx; |
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x) |
xxxxx agentura xxxxxxx xxxxxx x xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4 xxxx 5 xxxxxxx X xxxxxxxx (XX) x. 528/2012 xxxxx xx. 4 odst. 2 x xxx xxxxxxxx poplatek xxxxx xx. 4 xxxx. 4. |
2. Xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx xxxxxx xxxxx xxxxxx 4 x 5 xxxxxxxx (XX) č. 528/2012 x xxxxxxxx xxx xxxxxxx xxxxxx xx xxxxxx xxxxxxxxx xx údaje předložené x xxxxxxx x xx. 6 xxxx. 3 uvedeného nařízení x zašle xxxxxxxxx xxxxxx x xxxxxx xxxxx hodnocení agentuře.
3. Xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx xxxxxxx účastníků, xxxxxxxxx hodnotící xxxxxxxxx xxxxx xxxxx xxxxx xxxxxxxxx xxxxxx. Xxxxxxxxx xxxxxx x xxxxxx zašle x jedné x xxxxxx xxxx, xxxxx toho, xx nastane xxxxxxx:
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x) |
365 xxx xx xxxxxxxxx xxxxxxxxx xxxxxxxx x xxxx. 1 xxxx. x), xxxxxx xxxxxxxx xxxxxxxx x xxxx. 1 xxxx. x) xxxx zaplacení xxxxxxxx xxxxxxxxx x xxxx. 1 xxxx. x) x xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx; |
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x) |
xx xxxxx stanovené v příloze XXX. |
4. Xxxx tím, xxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx své xxxxxx xxxxxxxx, umožní xxxxxxxxxxx xxxxx xx 30 xxx k xxxxxxxxx xxxxxx x x xxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx. Xxxxxxxxx příslušný xxxxx xxxx xxxxxxxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxx x xxxxxxxxx xxxx xxxxx xxxxxxxxx.
5. Pokud xx xxxxx, že jsou x xxxxxxxxx nutné xxxxxxxxxx informace, hodnotící xxxxxxxxx orgán účastníka xxxxx, xxx tyto xxxxxxxxx ve xxxxxxxxx xxxxx xxxxxxxxx, a xxxxxxxxx x xxx xxxxxxxx.
Xxxxx 365 xxx xxxxxxx x odstavci 3 se přeruší xx dobu ode xxx xxxxxxxx xxxxxxxxx xx xxx xxxxxxxx xxxxxxxxx. Xxxxx xx xxxx odůvodněno xxxxxxx xxxxxxxxxxxx xxxxx xxxx xxxxxxxxxxx okolnostmi, xxxxxxxxx xxxxxxxxxx následující xxxxx:
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x) |
365 xxx x xxxxxxx, xx xx doplňující xxxxxxxxx xxxxxx xxxxxx, xxxxx xxxxxx xxxxxx x xxxxx xxxxxxxx 98/8/XX xxxx v rámci xxxxxxx xxxxxxxxxxx xxx xxxxxxxxxxx xxxxxxx xxxxxxxx; |
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x) |
180 dní xx xxxxx ostatních případech. |
6. Xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxx, xx xxxxxxxx xxxxx xxxxxxx xxxxxx xxxx xxxx xxxxxx xxxx xxxxxxxxx xxxxxxxxx vyplývající x xxxxxxxxxxxxx xxxxxx xxxxxxxxxx x xxxxxxxxx biocidních přípravků xxxxxxxxxxxx xxxxxx xxxx xxxxxxxx xxxxxx látky, xxx xxxxx xxxxxxxxxxxx x xxxxxxx x xxxxxxxxx příslušných xxxxx xxxxxx XX xxxx 3 přílohy XX xxxxxxxx Evropského xxxxxxxxxx a Xxxx (XX) x. 1907/2006 (8) x xxxxxx xx xx xxxxx xxxxxx.
7. X případě potřeby xx xxxxxxxxx xxxxxxxxx xxxxxxxxxxxxx hodnotící příslušný xxxxx xxx zbytečného xxxxxxx x xxxxxxxxxx při xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx xxxxxxxx 3:
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a) |
xxxxxxxx xxxxx xxxxxxxx xxxxx xx. 37 odst. 1 xxxxxxxx (XX) x. 1272/2008, jestliže xx xxxxxxx, xx xx xxxxxxx xxxxx x xxxxxxxx xxxxxxxxx x xx. 36 odst. 1 xxxxxxxxx nařízení, ale xxxx xxxxxxxx řešeno x xxxxx 3 přílohy VI xxxxxxxxx xxxxxxxx; |
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x) |
xxxxxxxxxx s agenturou, xxxxx xx domnívá, xx xxxxx x xxxxxxxx čl. 5 xxxx. 1 písm. d) xxxx x) xxxxxxxx (EU) x. 528/2012 nebo podmínka xx. 10 xxxx. 1 xxxx. x) xxxxxxxxx xxxxxxxx jsou xxxxxxx, xxx xxxxxx xxxxxxxx řešeny v příloze XXX xxxxxxxx (ES) x. 1907/2006 xxxx x xxxxxxx xxxxxxxx x xx. 59 xxxx. 1 xxxxxxxxx xxxxxxxx. |
Xxxxxx 7
Xxxxxxxxxx xxxxxxxx
1. Xxxxx xxxxxx xx použije, xxxxx platí některá x xxxxxx xxxxxxxx:
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x) |
pokud hodnotící xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx zprávu xxxxx xx. 6 xxxx. 2 x xxxxxxxx předložil xxxxx xxxx xxxxxxx xxxxxxxxxx xxxxx xx. 6 xxxx. 7; |
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x) |
xxxxx xxxx xxxxxxxxxx Xxxxxx xxxxxx příslušného orgánu xxxxx xx. 14 xxxx. 4 xxxxxxxx (XX) x. 1451/2007, xxx xxxxxxxxx zprávu xxxxx xxxxxxxxxxxx Xxxxx xxxxx pro xxxxxxxx xxxxxxxxx xxxxx čl. 15 xxxx. 4 xxxxxxxxx nařízení. |
2. Po xxxxxxx xxxxxx agentura xxxxxxxxx x xxxxxxxx Xxxxxx xxxxxxxxxx o schválení kombinace xxxxx a typu xxxxxxxxx xxxx xxxx xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx X xxxxxxxx (XX) č. 528/2012, xxxxxxxx xxxxxx, x xxxxxxx xx xxxxxx xxxxxxxxxxx xxxxxxxxxxx xxxxxx.
Xxxxxxxx xxxxxx přípravu xxxxxxxxxx x xxxxx z těchto xxxx, xxxxx toho, xx nastane xxxxxxx:
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x) |
xx xxx měsíců xx xxxxxxx xxxxxx; |
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b) |
xx lhůtě xxxxxxxxx x xxxxxxx III. |
Xxxxxxxx xxxxxxxx stanovisko Xxxxxx xx 270 xxx xx xxxxxxxx xxxxxxxx.
Xxxxxx 8
Xxxxxx látky, xxxxx se xxxx xxxxxxxx
1. Xxx xxxxxxxx xxxxx xxxxxxxxxx xxxxx xx. 7 xxxx. 2 xxxxxxxx xxxxxxx, xxx xxxxxx xxxxx xxxxxxx xxxxxxx x xxxxxxxx xxxxxxxxx v čl. 10 odst. 1 xxxxxxxx (EU) x. 528/2012, x xxxx xxxxxx xxxxx xx xxxx xxxxxxxxxx.
2. Xxxx xxxx xxxxxxx xxxxxx 66 x 67 xxxxxxxx (EU) x. 528/2012, dříve xxx xxxxxxxx xxxxxxxx xxx xxxxxxxxxx Xxxxxx, zveřejní xxxxxxxxx x xxxxxxx látkách, xxxxx xx xxxx xxxxxxxx, xxxxx xxxxxxxxx 60 xxx; v xxxx době xxxxx xxxxxxxxxx xxxxx strany xxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxxx. Agentura obdržené xxxxxxxxx xxxxxxxx zohlední x xxxxxxxxx fázi xxxxxxxx xxxxx xxxxxxxxxx.
3. Xxxxx xx xxxxxx látka xxxxxxxxx a splňuje jedno x xxxxxxxx xxxxxxxxxxx v čl. 10 xxxx. 1 xxxxxxxx (XX) x. 528/2012, musí xxx xxxxxxxx xx xxxxx, xxxxx se xx xxxxxxxx, x xxxxxxxx xxxxxxxx x xxxxxxx x xx. 89 odst. 1 xxxxxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxx.
Xxxxxx 9
Xxxxxxxxxx Xxxxxx
Xx xxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx xx. 7 xxxx. 2 Xxxxxx xxx zbytečného xxxxxxxx xxxxxxxx xxxxx xxxxxxxxxx pro xxxxxxx xxxxx xx. 89 xxxx. 1, xxxx xxxxxxxx xxxxx xx. 28 odst. 1 nařízení (XX) x. 528/2012.
XXXXXXXX 3
XXXXX XXXXX XXXXXXXX PŘEZKUMU
Článek 10
Xxxxxxxxx xxxx xxxxxxxxx xxxxxxxxx xx xxxxxxxx xxxxxx
1.&xxxx;&xxxx;&xxxx;Xxxx xxxxxxxxx xx možno xx xxxxxxxx dohodě xxxx stávajícím xxxxxxxxxx x xxxxxxxxxxxx xxxxxxxxxx xxxxxxx xxxx xxxxxx xx xxxxxxxxxxx, xx xx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx xx xx xxxxxxx xxxxx xxxxxxxxxx xxxx xxxxxxx xxxxxxxxxx xxxxxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxxx xxx xxxxx xxxxxx článku xxxxxxxxxxx xxxxxxxx společně xxxxxxxxxxx a stávající xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx xxx xxxxxxxx xxxxxxxxx uvedeného x xxxxxx 71 xxxxxxxx (XX) x. 528/2012 (dále xxx „xxxxxxxx“) x&xxxx;xxxxxxxx musí xxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxx k přístupu.
3. Po xxxxxxxx xxxxxxxx splňujícího xxxxxxxxx podle xxxxxxxx 2 xxxxxxxx xxxxxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxx xxxxxxxx xx xxxxxxxxxx účastníka.
4. Osoba xxxxxxx xx&xxxx;xxxxx Xxxx, xxxxx xxxxxxxx xxxx xxxxxxxxx xxxx xx xxxxxxxxx x xxxxxxxxxxx xxxxx tohoto xxxxxx, xx xxx xxxxx xxxxxx 95 xxxxxxxx (XX) x.&xxxx;528/2012 xxxxxxxxxx xx xxxxx, xxxxx xxxxxxxxxx dokumentaci xxxx xxxxxxxx x xxxxxxxx x dokumentaci.
Xxxxxx 11
Odstoupení účastníků
1. Má xx za xx, xx xxxxxxxx xxxxxxxxx x účasti na xxxxxxx xxxxxxxxx xxxxx x xxxx přípravku v programu xxxxxxxx, x xxxxxx xxxxxxxxx:
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x) |
xxxxx xxxxxxxxxx xxxxxxxx xxxx xxxxxxxxx příslušný xxxxx prostřednictvím xxxxxxxxx x svém záměru xxxxxxxxx; |
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x) |
xxxxx xxxxxxxxxxx žádost xx lhůtě uvedené x xx. 3 xxxx. 2; |
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x) |
xxxxx xxxx xxxxxx byla xxxxxxxxx xxxxx xx. 4 xxxx. 1, xx. 4 xxxx. 4 xxxx xx. 5 odst. 4; |
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xxxxx xxxxxxxxxxx xxxxxxxxxx informace xx xxxxxxx xxxxxxxxx x xx. 6 xxxx. 5; |
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xxxxx jinak xxxxxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxxxxx xxxxxx xxxx agentuře. |
2. Odstoupení xx xxxxxxxx za xxxxxxxxx xxxx, pokud x xxxx xxxxxxx xx xxxx, xxx xxxxxxxxx xxxxxxxxx orgán xxxxxxxxx xxxxxxxx xxxxxx xxxxxxxxxxx xxxxxx xxxxx xx. 6 odst. 4 xxxxxx xxxxxxxx.
Xxxxxx 12
Xxxxxxxx xxxxxxxx xxxxxxxxxx
1. Xxxxx xx o xxxxxxx odstoupení xxxxxxxxxx xxxxxxxxx příslušný orgán, xxx nikoli xxxxxxxx, xxxxxxxxx xx xxxxxxxxx xxxxxxxxx xxxxx bez xxxxxxxxxx xxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxx je x xxxxxxx xxxxxxxxxx informována xxxxxxxx, xxxxxxxxxxx xxxxxxxxx x xxxxxxxxx xxxxxxxx xx xxxxxxxxxx xxxxxxxxx.
3. Xxxxx z xxxxxxxx xxxxxxxx xxxx xxxxxxxxxx všichni xxxxxxxxx xxxxxxxxxxx xxxxx kombinaci xxxxx x xxxx xxxxxxxxx x xxxxx xxxx xxxx xxxxxxxxx xxx uvedenou xxxxxxxxx dříve xxxxxxxx, xxxxxxxxx x xxx xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx Xxxxxx.
Xxxxxx 13
Xxxx xxxxxxxx xxxxxxxxx xxxxx
1. Pokud xxxxxxxxx xxxxxxxxx účinné látky xxxxxxxx xxxxxxx xxxxxx xxxxxxxx xx látky, xxx xxxx uvedeny x xxxxxxx XX, xxxxxxxxx xxxxxxxxx xxxxx xx xxxxxxxxxx x xxxxxxxx účastníkem xxxxxxx xxxxx xxxxxxxx xxxxx. Hodnotící xxxxxxxxx xxxxx x xxx xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx v rejstříku xxxxxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxx.
Xxxxxx 14
Xxxxxxxx xxxx xxxxxxxxx
1. Xxxxxxxx zveřejní xxxxxxxxx xxxxx x převzetí xxxx xxxxxxxxx pro xxxxxxxxx xxxxx a typu xxxxxxxxx, xxxxx xxxxxxx xxxxx x xxxxxx případů:
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xxxxx xxxxxxx účastníci podporující xxxxx kombinaci látky x xxxx xxxxxxxxx včas xxxxxxxxxx xxxxx xxxxxx 11 x xxxxxx role xxxxxxxxx xxx xxxxx xxxxxxxxx xxxxxx xxxxxxx převzata; |
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xx xxxxxxx xxxx xxxxxxxx xxxxx xxxxxx 13; x xxxxx xxxxxxx xx xxxxx xxxx xxxxx xx xxxxx, xx xxxxxx xx xxxxxxxx xxxxxxxxx identita x xxxxxxx XX, xxx xxxxxxx xxxx xxxxxxxx látky. |
2. Xx xxxxxxxx xxxxxx xxx dne xxxxxxxxxx xxxxx xxxxxxxx 1 xxxx xxxxxxxxx xxxxx xxxxxxxxx oznámení pro xxxxxxxxx xxxxx xxxxxx 17.
3. Xx xxxxxxxx xxxxxx xx xxxx xxxxxx tohoto xxxxxxxx x xxxxxxxx xxxx xxxxxxxxx xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx do části 2 xxxxxxx XX xxxxx xxxxxx 17.
Xxxxxx 15
Kombinace xxxxx x xxxx přípravku xxxxxxxxx pro xxxxxxxx xx xxxxxxxx xxxxxxxx
Pokud xxxxxxxx xxxxxxxxx, xxxxx xxxxx do xxxxxxx xxxxxxxxxx xxxxxxxx (XX) x. 528/2012 x xx xxxxxx xx xxx, xxxxxxx ze xxxxxxxxx xxxxxx látky, xxx xxxx schválena xxx xxxxxxxx xx programu xxxxxxxx pro tento xxx xxxxxxxxx x xxxx xxxxxxxx xx xxxxxxx X xxxxxxxxx xxxxxxxx, xxxx látku xxxxxxxx xxxx xx x xx xxxxxx, xx xxxxxxx látka xxxxxxxxx pro xxxxxxxx xx xxxxxxxx xxxxxxxx pro xxxxxxxxx typ přípravku xx xxxxxxx některého z těchto xxxxxx:
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x) |
xxxxx xxxxxxxxx výrobek xx xxx xx spoléhala xx pokyny xxxx xxxxxxx xxxxxxxxxx xxxxxx Xxxxxx xxxx příslušným xxxxxxx xxxxxxxxxx v souladu x xxxxxxx 26 xxxxxxxx 98/8/XX xxxx článkem 81 xxxxxxxx (XX) x. 528/2012, xxxxx xx xxxxxxx xxxxxxxxxx xxxxxxxxxxxxxx xxxxxx xxxxx xxxxxxx xxxxxx xx doporučení k xxxxxxxxxxx, že výrobek xxx xxxxx z působnosti xxxxxxxx 98/8/XX xxxx xxxxxxxx (XX) x. 528/2012, nebo xx xxx příslušný xxx xxxxxxxxx jedním x xxxxxxxxx, pro xxxxx xxxx xxxxxx xxxxx xxxxxxxx, x xxxxx xxxx xxxxxxx xxxxxx xx xxxxxxxxxx xxxxxxxx xxxxxxxxxxx x xxxxxxxxxx xxxxxxxx xxxxx xx. 3 odst. 3 xxxxxxxx (XX) č. 528/2012 xxxx v nových, xxxxxxxxx xxxxxxxx xxxxxxxxxxxx Xxxxxx; |
|
b) |
xxxxx xxxxxxxxx odchylky xxx xxxxxxxxx x xxxxxx stanovené x xxxxxx 6 nařízení (XX) x. 1451/2007; |
|
x) |
biocidní xxxxxxxxx xxxxx xxxxx xxxxxxxx (XX) x. 528/2012 k xxxxxxxxx xxxx xxxxxxxxx, xxx tomu bylo xxxxx směrnice 98/8/ES, x xxxxxxxx xxxxx xxxxxxxxxx xxxxxx xxxx přípravků x xxxxxxxx xxxxx zařazenou do programu xxxxxxxx pro xxxxxxx xxx přípravku, xxx xxxxxx xxx nový. |
Xxxxxx 16
Xxxxxxxxxx o xxxxx xx xxxxxxxx
1. Xxxxxxxxxx x xxxxx xxxxxxx látku, xxxxx xx xxxxxxxxx xxx zařazení do programu xxxxxxxx podle xxxxxx 15, xxxxxxxxx prostřednictvím xxxxxxxxx xxxxxxxxx osoba, xxx xx zájem xxxxxxx kombinaci xxxxx x xxxx xxxxxxxxx, jednomu x následujících xxxxxxxx:
|
x) |
Komisi xxxxxxxxxx xxxxxxx měsíců xx xxxxxxxxxx rozhodnutí xxxx xxxxxx xxxxxxxxx x xx. 15 písm. a); |
|
x) |
xxxxxxxx xxxxxxxxxx 30. října 2015 x xxxxxxxxx xxxxxxxxx x čl. 15 xxxx. x); |
|
c) |
Xxxxxx xxxxxxxxxx 30. xxxxx 2015 x xxxxxxxxx xxxxxxxxx x xx. 15 xxxx. x). |
2. Xxxxxxxxxx xxxx obsahovat xxxxxxxxxx xxxxxxxxx látky x xxxx xxxxxxxxx. X xxxxxxxxx xxxxxxxxx x xx. 15 xxxx. x) xxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxxxxx odůvodnění, x xxxx xxxxxxx, xx xxxx xxxxxxx xxxxxxx xxxxxxxx x xxx uvedené.
3. Pokud xxxx xxxxxxxxxx xxxxxxx v případě xxxxxxxx x xx. 15 xxxx. x) xxxx x) x Xxxxxx dospěje xx xxxxxxxxxx x xxxxxxxxx xxxxx x xxxxxx, xx xxxxxxxx 6 není xxxxxxxxxx, a případně, xx xxxx xxxxxxx xxxxxxxx xxx xxxxxxxx uvedené x xx. 15 písm. x), xxxxxxx x xxx xxxxxxxx.
4. Xxxxx xxxx xxxxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 xxxx. b) xxxx pokud Xxxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 3, xxxxxxxx xxxxxxxx xxxx xxxxxxxxx elektronickými xxxxxxxxxx x xxxxxxxx příslušné xxxxxxxxx xxxxx a typu xxxxxxxxx. Xxx xxxxx xxxxxx xxxxxxxx xx xxxxxxxxxx xxxxx xx. 3x xxxx. 3 xxxxxxx xxxxxxxxxxx xxxxxxxx (XX) x. 1451/2007 xxxxxxxx za xxxxxxxxxx xxxxx tohoto odstavce.
5. Kterákoli xxxxx, xxxxx má xxxxx oznámit xxxxxxxxx xxxxx x xxxx xxxxxxxxx, xxx může xxxxxx podle xxxxxx 17 xx xxxxx měsíců xxx xxx xxxxxxxxxx xxxxx xxxxxxxx 4.
6. X xxxxxxxxx xxxxxxxxx x xx. 15 xxxx. x) a c) se xxxxxxxxx látky a typu xxxxxxxxx považuje za xxxxxxxxx xxxxxxxxxx x xxxx xxxxxxxxx k xxxxxxx xxxxxxxx, pokud jsou xxxxxxx xxxx xxxxxxxx:
|
x) |
xxxxxxxxx xxxxxx látka je xxx xxxxxxxx do programu xxxxxxxx; |
|
x) |
xxxxxxxxxxx předložená xxxxxxxxxxx xxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxx xxxxx xxx obsahuje všechny xxxxx, které xxxx xxxxxxxx pro hodnocení xxxx xxxxxxxxx; |
|
c) |
xxxxxxxx, xxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxxx, xxxxx, že xx xxxxx x xxxxxxx xxxx xxxxxxxxx látky x xxxx xxxxxxxxx. |
Xxxxxx 17
Xxxxxx oznámení
1. Xxxxxxxx xxxxx xx. 14 xxxx. 2 x 3 nebo xx. 16 xxxx. 5 xx xxxxxxxxxxx xxxxxxxx prostřednictvím xxxxxxxxx.
2. Xxxxxxxx xxxx xxx xxxxxxxxxx ve xxxxxxx XXXXXX. Xxxx xxxxxxxxx xxxxx xxxxxxx v xxxxxxx I.
3. Xxxxx není x xxxxxxx XX xxx xxxxxxxx xxxxxxx xxxxx uveden xxxxxxxxx xxxxxxxxx xxxxx, xxxxxxxxx xxxxxxxxxxx xxxxxxxx x xxxxx xxx xxxxxxxxx xxxxxxxxxxx xxxxxx, který xx xxxxxxxx x xxxxxxx x xxxxxxx 81 xxxxxxxx (XX) x. 528/2012, x xxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx, xx xxxxxxxxx xxxxx souhlasí x xxx, xx dokumentaci xxxxxxx.
4. Xx xxxxxxxx xxxxxxxx x xxx xxxxxxx xxxxxxxx Xxxxxx a xxxxxxxxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxxx xxxxx nařízení (XX) x. 564/2013. Xxxxxxxx xxxxxxxxxxx xxxxxxxx xxxxxxxx xx 30 xxx xx xxxxxxx xxxxxxx xxxxxxxxx, agentura xxxxxxxx xxxxxxx x xxxxxxx x xxx oznamovatele x Komisi.
5. Xx xxxxxxxx xxxxxxxx xxxxxxxx xx 30 dnů xxxxx, xxx oznámení vyhovuje xxxxxxxxxx xxxxxxxx x xxxxxxxx 2. Pokud xxxxxxxx xxxxx požadavkům xxxxxxxxxx, xxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxx v xxxxx 30 dnů, xxx xxx xxxxxxxx xxxxxxx xxxx xxxxxxx. Xx uplynutí xxxx 30xxxxx lhůty xxxxxxxx xx 30 dnů xxx xxxxxxxx, že xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxx 2, nebo xxxxxxxx zamítne, a xxx xxxxxxxxxx xxxxx xxxxxxxxxxxx x Komisi.
6. X xxxxxxx x článkem 77 xxxxxxxx (XX) x. 528/2012 xxxxx xxxxxxxxxxx agentury podle xxxxxxxx 4 xxxx 5 xxxxx xxxxxxx xxxxxxxxxx.
7. Xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxx xxxxxxxx 5:
|
a) |
x xxxxxxx, xx bylo xxxxxxxx xxxxxxxxxx podle xx. 14 odst. 2 nebo 3, xxxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx v xxxxxxxxx týkající se xxxxxxxxxx xxxxxxxxx x xxxxxxxx identity xxxxx; |
|
x) |
x xxxxxxx, xx xxxxxxxx bylo xxxxxxxxxx podle čl. 16 xxxx. 5, xxxxxxxx xxxxxxxxxx xxxxxxxxx Xxxxxx, že xxxxxxxxxx xxxx vyhověno. |
Xxxxxx 18
Xxxxxxxx do xxxxxxxx xxxxxxxx
Xxxxx je xxxxxxxxx xxxxx a typu xxxxxxxxx xxxxxxxxxx xx xxxxxxxxx x xxxxxxx x xx. 16 xxxx. 6 xxxx xxxxx xxxxxxxx xxxxxxxxx Xxxxxx x dodržení xxxxxxxxx x xxxxxxx x xx. 17 xxxx. 7 xxxx. x), xxxxxx Xxxxxx xxxxxxxxx látky x xxxx přípravku xx xxxxxxxx xxxxxxxx.
Xxxxxx 19
Xxxxxxxxx x xxxxxxx, xxxxx xxxxxx xxxxxx xxxxxxxxxxx v xxxxx xxxxxxxx xxxxxxxx
Xxxxx xxxxxx xx xxxxx xxxxxxxxx x xx. 16 xxxx. 5 xxxxxxxx xxxxx xxxxxxxx xxxx xxxxx xxxx oznámení xxxxxxx ve xxxxxxxx xxxxxx xxxxxxx x xxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xx. 17 xxxx. 4 xxxx 5, agentura x xxx xxxxxxxxx xxxxxxx xxxxx xxxxxxxxxxxxxxx rejstříku a zveřejní xxxx informaci xxxxxxxxxxxxx xxxxxx.
Xxxxxx 20
Rozhodnutí Xxxxxx x xxxxxxx, které xxxxxx xxxxxx podporovány x rámci programu xxxxxxxx
Xxxxxx připraví xxxxx xxxxxxxxxx o neschválení xxxxx čl. 89 xxxx. 1 xxxxxxx xxxxxxxxxxx nařízení (XX) č. 528/2012 x xxxxxx xxxxxxxxx:
|
x) |
xxxxx xxxxxxxx xxxxxxxxx Xxxxxx x xxxxxxx xxxxxxxxxx xxxxxxxxx podle xx. 12 xxxx. 3 xxxxxx nařízení; |
|
x) |
pokud xxxxx xxxxx xxxxxxxx xxxxxxxx ve lhůtách xxxxxxxxxxx x xx. 14 xxxx. 2 nebo 3 xxxxxx nařízení xxxx xxxxx xxxx xxxxxxxx xxxxxxxxxx x xxxxxxxxx xxxxx xx. 17 xxxx. 4 xxxx 5; |
|
x) |
xxxxx xxxx xxxxxxxx předloženo ve lhůtě xxxxxxxxx v čl. 14 odst. 2 xxxx 3 xxxxxx xxxxxxxx x xxxx dodrženy xxxxxxxxx podle xx. 17 xxxx. 5 xxxxxx nařízení, xxx xxxxxxxx xxxxx x xxxxxxxx xxxxxxxx pouze xxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX xxxxxx xxxxxxxx. |
X xxxxxxx xxxxxxxx x xxxxxx xxxxxxxxxxx xxxx. x) se xxxxx rozhodnutí x xxxxxxxxxxx vztahuje na xxxxxx xxxxx, xx xxxxxx xx xxxxxxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX xxxxxx xxxxxxxx, xxxxx xxxxxx xxxxxxxx xxxx jakékoli xxxxxxxxxx x xxxxxxxxx.
KAPITOLA 4
PŘECHODNÁ OPATŘENÍ
Článek 21
Xxxxxxxxx opatření xxx xxxxx xxxxxxx x&xxxx;xxxxxx&xxxx;15
1.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx pokračovat x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx nebo praxe xxxxxxxx xx&xxxx;xxx a používání xxxxxxxxxx xxxxxxxxx, xxxxx xxxxxxx ze xxxxxxxxx xxxxxx látky xxxxxxx x čl. 15 xxxx. b) x x), tuto xxxxx xxxxxxxx xxxx x xx xxxxxx. V xxxxxx xxxxxxxxx:
|
x) |
xxxxx být xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx na trh x&xxxx;xxxxxxx xx&xxxx;24 měsíců xx xxxx xxxxxx xxxxxx xxxxxxxx x&xxxx;xxxxxxxx; |
|
x) |
xxxxxxxxx xxxxxx xxxxxxxxxx přípravku xxxxx xxx xxxx využívány xx&xxxx;30 xxxxxx xx xxx xxxxxx tohoto xxxxxxxx x&xxxx;xxxxxxxx. |
2.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx xxxxxxxxxx v uplatňování xxxxx xxxxxxxxxxx systému xxxx xxxxx xxxxxxxx xx&xxxx;xxx a používání biocidního xxxxxxxxx, xxxxx xxxxxxx xx stávající účinné xxxxx xxxxxxx x xx. 15 písm. x), xxxx látku xxxxxxxx nebo x xx xxxxxx. X xxxxxx xxxxxxxxx:
|
x) |
xxxxx xxx xxxxxxxx xxxxxxxxx nadále xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;24 xxxxxx po xx z dále xxxxxxxxx xxxxxxxx, která xxxxxxx později:
|
|
x) |
xxxxxxxxx xxxxxx xxxxxxxxxx přípravku xxxxx xxx xxxx xxxxxxxxx do 30 měsíců xx xx z xxxx uvedených xxxxxxxx, xxxxx nastane xxxxxxx:
|
3.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx xxxxxxxxxx v uplatňování svého xxxxxxxxxxx xxxxxxx xxxx xxxxx xxxxxxxx na trh x&xxxx;xxxxxxxxx biocidního xxxxxxxxx, xxxxx sestává xx xxxxxxxxx xxxxxx látky xxxxxxxxxx xxxxxxxxx xxxxx xx. 16 xxxx. 4 pro příslušný xxx xxxxxxx, xxxx xxxxx xxxxxxxx xxxx x ní vzniká. X xxxxxx xxxxxxxxx:
|
x) |
xxxxx xxx xxxxxxxx přípravek xxxxxx xxxxxxx na trh x&xxxx;xxxxxxx xx&xxxx;xxxxxxxx xxxxxx xx datu, xxx xxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxx xxxxxx 19 a |
|
b) |
stávající xxxxxx xxxxxxxxxx xxxxxxxxx mohou xxx xxxx xxxxxxxxx xx&xxxx;xxxxxxxx xxxxxx po xxxx uvedeného zveřejnění. |
Xxxxxx 22
Xxxxxxxx xxxxxxx
1. Xxxx xx dotčen xx. 55 xxxx. 1 xxxxxxxx (XX) x. 528/2012, do osmnácti měsíců xx xxxx xxxxxxxxxx x xxxxxxxxxxx xxxxxxxxx xxxxxx látky, xxxxx xxxxxxx xxxx xxxxxxxx tuto stávající xxxxxxx látku xx xxxxxxxxx z důvodů uvedených x xx. 5 xxxx. 2 xxxxxx pododstavci xxxx. x) nebo x) xxxxxxxx (XX) x. 528/2012, xxxxx členský xxxx xxxx předložit Xxxxxx odůvodněnou xxxxxx x xxxxxxxx xx xx. 89 xxxx. 2 xxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx xxxxxxx stát xxxxxxxx odůvodněnou xxxxxx xxxxxxxx xxxxxxxxxxxxxxx rejstříku. Xxxxx žádost obsahuje xxxxxxx xxxxxxxxx, xxxxxxxx xxxxxxx xxxx xxxx xxxxxxx xxxxxxxxx xxxxxxxxx xxxxx.
3. Xxxxxxxx xxxxxxxx xxxxxx xxxx xxxxxxxx xxxxxxxxxx xxxxx xxxxxxxxxxxxxx xxxxxxxxxx. Xxxxxxx státy nebo xxxx xxxxx xxxxx xxxxx xxxxxxxxxx xx xxxxx 60 xxx xx xxxxxxxxxx.
4. Xx xxxxxxx xxxxxxxxxx xxxxxxxxxx xxxx Komise xxxxxxx xxxxxxxx xx xx. 89 xxxx. 2 druhého xxxxxxxxxxx xxxxxxxx (EU) č. 528/2012, xxxxx xxxxxx xxxxxx xxxxxxxx xxxxxxxxx, xxx xxxxxxxxx x této xxxxx, obsahují xx xxxx z xx xxxxxxxx, xx xxx xxxxxxxxxx členského státu x xxxxxxxx xx x xxxxx xxxxxxxx státu x xxxxxxx x xxxxxxxxxxxxxx právními xxxxxxxx x x xxxxxxxx xxxxxxxx xxxxxxxx 5 x xxxxxxxxx xxxxxxx xxxxxxxx xxxxxxxxx Xxxxxx.
5. Xxxxxxx xxxx, jemuž xx xxxxxxxx xxxxxxxx:
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a) |
xxxxxxx, xx xxxxx xxxxxxxxx xxxx omezeno xx xxxxxx xxxxxxx x xxxxxxx dobu, xxx xxxx xxxxxx xxxxxxxx xxxxxxxx 1; |
|
x) |
xxxxxx vhodná opatření xx xxxxxxxx rizik, aby xxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxxxx, xxxxxx xxxx xxxxxxxxx xxxxxxxxx; |
|
x) |
xxxxxxx, aby xx hledala xxxxxxxxxxxx xxxxxx xxxx xxx xxxx xxxx xxxx xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxx x xxxxxxxxx xxxxxx xxxxx x xxxxxxx xxxxxxx 7 xxxxxxxx (XX) x. 528/2012. |
XXXXXXXX 5
ZÁVĚREČNÁ XXXXXXXXXX
Xxxxxx 23
Xxxxxxx
Xxxxxxx xx xxxxxxxx (XX) x. 1451/2007.
Xxxxxx xx xxxxxxx nařízení xx xxxxxxxx xx xxxxxx na xxxx xxxxxxxx.
Xxxxxx 24
Vstup x xxxxxxxx
Xxxx xxxxxxxx vstupuje x platnost xxxxxxxx xxxx xx vyhlášení x Xxxxxxx xxxxxxxx Xxxxxxxx unie.
Xxxx xxxxxxxx xx xxxxxxx x xxxxx xxxxxxx x přímo xxxxxxxxxx xx všech xxxxxxxxx xxxxxxx.
X Bruselu xxx 4. xxxxx 2014.
Xx Komisi
xxxxxxxx
Xxxx Manuel XXXXXXX
(1)&xxxx;&xxxx;Xx. xxxx. X 167, 27.6.2012, x. 1.
(2)&xxxx;&xxxx;Xxxxxxxx Komise (XX) x. 1451/2007 xx xxx 4. prosince 2007 o xxxxx xxxxx desetiletého xxxxxxxxxx xxxxxxxx uvedeného v xx. 16 xxxx. 2 xxxxxxxx Evropského xxxxxxxxxx x Rady 98/8/XX o xxxxxxx xxxxxxxxxx přípravků xx xxx (Xx. xxxx. X 325, 11.12.2007, x. 3).
(3)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Rady 98/8/XX xx dne 16. xxxxx 1998 o xxxxxxx xxxxxxxxxx xxxxxxxxx xx xxx (Úř. xxxx. X 123, 24.4.1998, s. 1).
(4)&xxxx;&xxxx;Xxxxxxxx Soudního dvora (xxxxxxx xxxxxx) xx xxx 1. března 2012 (xxxxxx x xxxxxxxxxx o xxxxxxxxx xxxxxx: Landgericht Xxxxxxx – Německo) – Xöxx XxxX proti Xxxxx XxxX (xxxxxxx xxxxxxxxxx xxxxxxxxx xx xxx – xxxxxxxx 98/8/XX – xx. 2 xxxx. 1 xxxx. x) – xxxxx „xxxxxxxx přípravky“ – přípravek, xxxxx xxxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx, xxxx xx xxxx, xxxxxxxx nebo xxxxxxxxxxx), X-420/10.
(5)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Xxxxxx (XX) x.&xxxx;88/2014 xx xxx 31. ledna 2014, xxxxxx xx stanoví xxxxxx xxx xxxxx xxxxxxx X&xxxx;xxxxxxxx Xxxxxxxxxx xxxxxxxxxx a Rady (EU) x.&xxxx;528/2012 o dodávání xxxxxxxxxx xxxxxxxxx xx xxx x&xxxx;xxxxxx xxxxxxxxx (Xx. xxxx. X 32, 1.2.2014, x. 3).
(6)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (ES) x. 1272/2008 xx xxx 16. prosince 2008 x xxxxxxxxxxx, xxxxxxxxxx x xxxxxx xxxxx a směsí, x změně x xxxxxxx xxxxxxx 67/548/XXX x 1999/45/XX x x xxxxx xxxxxxxx (XX) x. 1907/2006 (Xx. věst. X&xxxx;353, 31.12.2008, x. 1).
(7)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Xxxxxx (XX) č. 564/2013 xx xxx 18.&xxxx;xxxxxx 2013 x&xxxx;xxxxxxxxxx a platbách xxxxxxxxx Xxxxxxxx xxxxxxxx pro xxxxxxxx xxxxx xxxxx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;528/2012 x&xxxx;xxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxx x&xxxx;xxxxxx xxxxxxxxx (Úř. věst. L 167, 19.6.2013, s. 17).
(8) Nařízení Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 1907/2006 ze xxx 18. xxxxxxxx 2006 x xxxxxxxxxx, xxxxxxxxx, povolování x xxxxxxxxx xxxxxxxxxx xxxxx, x xxxxxxx Xxxxxxxx xxxxxxxx xxx xxxxxxxx xxxxx, x xxxxx xxxxxxxx 1999/45/XX x x zrušení xxxxxxxx Xxxx (EHS) č. 793/93, xxxxxxxx Komise (XX) x. 1488/94, xxxxxxxx Xxxx 76/769/XXX a xxxxxxx Xxxxxx 91/155/XXX, 93/67/XXX, 93/105/XX x 2000/21/XX (Xx. věst. X 396, 30.12.2006, x. 1).
XXXXXXX I
Xxxxxxxxx xxxxxxxxxx xxx oznámení podle xxxxxx 17
Xxxxxxxx podle xxxxxx 17 xxxxxxxx xxxx informace:
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1) |
xxxxx, xx xxxxx xx stávající xxxxxxx xxxxxx xx xxxxxx xx. 3 xxxx. 1 xxxx. x) xxxxxxxx (XX) č. 528/2012; |
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2) |
xxxxx x xxxx/xxxxxx xxxxxxxxx, na xxxxx/x xx xxxxxxxx xxxxxxxx; |
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3) |
xxxxxxxxx x xxxxx xxxxxxxx, xxxxx xxxx xxxxxx xxx xxxxx žádosti x xxxxxxxxx xx xxxxxxxx xx xxxxxxx X xxxxxxxx (XX) x. 528/2012, xxxxx x xxxxxxxxx xxxxx xxxxxx dokončení; |
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4) |
informace xxxxxxx v xxxxxxxx
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|
5) |
xxxxx xxxx toto xxxxxxxx xxxxxxx v případě xxxxxxxx x xx. 15 xxxx. x), xxxxx, xx xxxxx xxxx xx xxxx xxxx účinná xxxxx biocidního xxxxxxxxx xxxxxxxxxxx do příslušného xxxx xxxxxxxxx x xxx xxxxxxxx xxxx xxxxxxxxxx xxxxxxxxxx xxxx xxxxxx xxxxxxxxx xx zmíněném xxxxxxx. |
XXXXXXX XX
KOMBINACE XXXXX X XXXX XXXXXXXXX ZAŘAZENÉ XX XXXXXXXX XXXXXXXX XXX 4. XXXXX 2014
ČÁST 1
Xxxxxxxxx xxxxxx látky x xxxx xxxxxxxxx podporované xx xxx 4. xxxxx 2014, s výjimkou xxxxxxxxxx xxxxxx xxxxxxxxxxxxx xxx xxxx, které xxxx výslovně xxxxxxx x xxxxxxxxx 1017 a 1019.
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Číslo xxxxxxx |
Xxxxx látky |
Xxxxxxx xxxx xxxxxxxxx |
Xxxxx XX |
Číslo CAS |
1 |
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7 |
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11 |
12 |
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17 |
18 |
19 |
21 |
22 |
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1 |
xxxxxxxxxxx |
XX |
200-001-8 |
50-00-0 |
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6 |
5-{[2-(2-xxxxxxxxxxxx)xxxxxx]xxxxxx}-6- xxxxxx-1,3-xxxxxxxxxxx (xxxxxxxxxxxxxxxx/XXX) |
XX |
200-076-7 |
51-03-6 |
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9 |
xxxxxxxx |
XX |
200-143-0 |
52-51-7 |
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x |
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29 |
xxxxxxxxxxx |
XX |
200-431-6 |
59-50-7 |
x |
x |
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x |
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x |
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36 |
xxxxxxx |
XX |
200-578-6 |
64-17-5 |
x |
x |
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x |
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37 |
xxxxxxxx xxxxxxxx |
XX |
200-579-1 |
64-18-6 |
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x |
x |
x |
x |
x |
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x |
x |
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40 |
xxxxxx-2-xx |
XX |
200-661-7 |
67-63-0 |
x |
x |
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x |
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43 |
kyselina xxxxxxxxxx |
NL |
200-712-3 |
69-72-7 |
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x |
x |
x |
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45 |
propan-1-ol |
XX |
200-746-9 |
71-23-8 |
x |
x |
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x |
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52 |
ethylenoxid |
N |
200-849-9 |
75-21-8 |
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x |
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60 |
kyselina xxxxxxxxx |
XX |
201-069-1 |
77-92-9 |
x |
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69 |
xxxxxxxxx kyselina/2-hydroxyethanová xxxxxxxx |
XX |
201-180-5 |
79-14-1 |
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x |
x |
x |
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70 |
xxxxxxxx xxxxxxxxxxxx |
XX |
201-186-8 |
79-21-0 |
x |
x |
x |
x |
x |
x |
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x |
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71 |
X-(+)-xxxxxx xxxxxxxx |
DE |
201-196-2 |
79-33-4 |
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x |
x |
x |
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79 |
2-isopropenyl-8,9-dimethoxy-1,2,6,6a,12,12a-hexahydrochromeno[3,4-b]furo[2,3-h]chromen-6-on (xxxxxxx) |
XX |
201-501-9 |
83-79-4 |
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85 |
xxxxxxxxx |
XX |
201-782-8 |
87-90-1 |
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92 |
xxxxxxx-2-xx |
XX |
201-993-5 |
90-43-7 |
x |
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113 |
xxxxxxxxxxxxx/3-xxxxxxxxx-2-xxxx (xxxxxxxxxxxxx) |
XX |
203-213-9 |
104-55-2 |
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117 |
xxxxxxxx |
XX |
203-377-1 |
106-24-1 |
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122 |
xxxxxxx |
XX |
203-474-9 |
107-22-2 |
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x |
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133 |
xxxx-2,4-xxxxxxx xxxxxxxx (xxxxxxxx xxxxxxx) |
XX |
203-768-7 |
110-44-1 |
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x |
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136 |
xxxxxxxx (xxxxxxxxxxxxx) |
FI |
203-856-5 |
111-30-8 |
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x |
x |
x |
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x |
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154 |
chlorofen |
X |
204-385-8 |
120-32-1 |
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x |
x |
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171 |
2-xxxxxxxxxxx-1-xx |
UK |
204-589-7 |
122-99-6 |
x |
x |
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172 |
xxxxxxxxxxxxxxx-xxxxxxx/1-xxxxxxxxxxxxxxxx-1-xxx-xxxxxxx |
XX |
204-593-9 |
123-03-5 |
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x |
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179 |
oxid xxxxxxxx |
XX |
204-696-9 |
124-38-9 |
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x |
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180 |
(natrium-kakodylát) – xxxxxxx-xxxxxxxxxxxxxxx |
XX |
204-708-2 |
124-65-2 |
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x |
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185 |
xxxxxxxxxxxxxx, xxxxx xxx (sodná sůl xxxxxxxxxxxxxxx – chloramin X) – (X-xxxxx-4-xxxxxxxxxxxx-1-xxxxxxxxxx |
ES |
204-854-7 |
127-65-1 |
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x |
x |
x |
x |
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187 |
xxxxxx-xxxxxxxxxxxxxxxxxxxxxx |
XX |
204-875-1 |
128-03-0 |
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x |
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x |
x |
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188 |
natrium-dimethyldithiokarbamát |
XX |
204-876-7 |
128-04-1 |
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x |
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x |
x |
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195 |
xxxxxxx-xxxxxxx-2-xxxx |
XX |
205-055-6 |
132-27-4 |
x |
x |
x |
x |
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x |
x |
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x |
x |
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x |
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198 |
N-[(trichlormethyl)sulfanyl]ftalimid (xxxxxx) |
XX |
205-088-6 |
133-07-3 |
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x |
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x |
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206 |
xxxxxx |
XX |
205-286-2 |
137-26-8 |
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x |
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210 |
xxxxxx-xxxxxxx |
XX |
205-293-0 |
137-42-8 |
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x |
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x |
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227 |
2-(xxxxxxx-4-xx)xxxxxxxxxxxx (xxxxxxxxxxxx) |
ES |
205-725-8 |
148-79-8 |
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x |
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x |
x |
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235 |
diuron |
DK |
206-354-4 |
330-54-1 |
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x |
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x |
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239 |
xxxxxxxxxxxxx |
DE |
206-992-3 |
420-04-2 |
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x |
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x |
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253 |
xxxxxxxxxx-3,5-xxxxxxxx-1,3,5-xxxxxxxxxx-2-xxxxx (xxxxxxx) |
XX |
208-576-7 |
533-74-4 |
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x |
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x |
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279 |
X-[(xxxxxxxxxxxxxxxxxx)xxxxxxxx]-X′,X′-xxxxxxxx-X-(4-xxxxxxxxxxx)xxxxxxxxxx (xxxxxxxxxxxx) |
XX |
211-986-9 |
731-27-1 |
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x |
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283 |
xxxxxxxxx |
XX |
212-950-5 |
886-50-0 |
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x |
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x |
x |
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288 |
X-[(xxxxxxxxxxxxxxxxxx)xxxxxxxx]-X-xxxxx-X′,X′-xxxxxxxxxxxxxxxx (dichlofluanid) |
XX |
214-118-7 |
1085-98-9 |
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x |
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x |
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289 |
xxxxxxxxxxxx xxxxx |
XX |
214-183-1 |
1111-67-7 |
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x |
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292 |
[(1,3-xxxxx-1,3,4,5,6,7-xxxxxxxxx-2X-xxxxxxxx-2-xx)xxxxxx]-xxxxx-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxx-xxxxxxxxxxxx) |
XX |
214-619-0 |
1166-46-7 |
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x |
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958 |
xxxxxxxx xxxxxxxx/xxxxxxxxxxx vápno/hašené xxxxx |
XX |
215-137-3 |
1305-62-0 |
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x |
x |
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959 |
xxxx vápenatý/vápno/pálené vápno/nehašené xxxxx |
XX |
215-138-9 |
1305-78-8 |
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x |
x |
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306 |
xxxx xxxxx |
XX |
215-270-7 |
1317-39-1 |
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x |
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315 |
xxxxx-2-xx-xxxxxxx |
HU |
215-661-2 |
1338-23-4 |
x |
x |
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321 |
xxxxxxxxxxx |
XX |
217-129-5 |
1746-81-2 |
|
x |
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330 |
N-(3-aminopropyl)-N-dodecylpropan-1,3-diamin (xxxxxx) |
XX |
219-145-8 |
2372-82-9 |
|
x |
x |
x |
|
x |
|
x |
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x |
x |
x |
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336 |
X,X′-xxxxxxxx-2,2′-xxxxxxxxxxxxxxxxxxxxxx (XXXXX) |
XX |
219-768-5 |
2527-58-4 |
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x |
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339 |
1,2-xxxxxxxxxxxxxxx-3(2X)-xx (XXX) |
XX |
220-120-9 |
2634-33-5 |
|
x |
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x |
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x |
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x |
x |
x |
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341 |
2-xxxxxxxxxxxxxxxxxxxxxxxxxx-3(2X)-xx (MIT) |
XX |
220-239-6 |
2682-20-4 |
|
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x |
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x |
x |
x |
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346 |
natrium-dichlorisokyanurát xxxxxxxx |
XX |
220-767-7 |
51580-86-0 |
|
x |
x |
x |
x |
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x |
x |
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345 |
xxxxxxx-xxxxxxxxxxxxxxxxxx |
XX |
220-767-7 |
2893-78-9 |
|
x |
x |
x |
x |
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x |
x |
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348 |
xxxxx(xxxxxxxxx)xxxxxxxxxxxxxxx-xxxxx-xxxxxx (MES) |
XX |
221-106-5 |
3006-10-8 |
x |
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354 |
triklosan |
XX |
222-182-2 |
3380-34-5 |
x |
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359 |
(ethylendioxy)dimethanol (xxxxxxx xxxxxxxx xxxxxxxxxxxxxx a xxxxxxxxxxxxxxxx (XXXxxx)) |
XX |
222-720-6 |
3586-55-8 |
|
x |
|
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|
x |
|
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x |
x |
x |
|
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|
365 |
pyridin-2-thiol-1-oxid, sodná xxx (xxxxxxxxx xxxxx) |
SE |
223-296-5 |
3811-73-2 |
|
x |
x |
|
|
x |
x |
|
x |
x |
|
|
x |
|
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368 |
1-(3-xxxxxxxxxx)-3,5,7-xxxxxx-1-xxxxxxxxxxxxxxx-xxxxxxx (XXXX) |
XX |
223-805-0 |
4080-31-3 |
|
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|
x |
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x |
x |
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377 |
1,3,5-xxxx(2-xxxxxxxxxxxx)xxxxxxxxx-1,3,5-xxxxxxx (XXX) |
PL |
225-208-0 |
4719-04-4 |
|
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|
x |
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x |
x |
x |
|
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|
382 |
1,3,4,6-xxxxxxxx(xxxxxxxxxxxxx)xxxxxxxxxxxxxxxx[4,5-x]xxxxxxxx-2,5-xxxx (TMAD) |
XX |
226-408-0 |
5395-50-6 |
|
x |
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|
x |
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x |
x |
x |
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387 |
dimorfolinomethan (XXX) |
XX |
227-062-3 |
5625-90-1 |
|
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x |
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x |
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392 |
xxxxxxxx-xxxxxxxxxxxx |
XX |
228-652-3 |
6317-18-6 |
|
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x |
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393 |
1,3-xxx(xxxxxxxxxxxxx)-5,5-xxxxxxxxxxxxxxxxxxxx-2,4-xxxx (DMDMH) |
XX |
229-222-8 |
6440-58-0 |
|
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x |
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x |
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397 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxxx (XXXX) |
XX |
230-525-2 |
7173-51-5 |
x |
x |
x |
x |
|
x |
|
x |
|
x |
x |
x |
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401 |
xxxxxxx |
SE |
231-131-3 |
7440-22-4 |
|
x |
|
x |
x |
|
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x |
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403 |
xxx |
FR |
231-159-6 |
7440-50-8 |
|
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x |
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405 |
oxid xxxxxxxx |
XX |
231-195-2 |
7446-09-5 |
|
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x |
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424 |
xxxxxx xxxxx |
NL |
231-599-9 |
7647-15-6 |
|
x |
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x |
x |
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432 |
xxxxxxxx sodný |
XX |
231-668-3 |
7681-52-9 |
x |
x |
x |
x |
x |
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x |
x |
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434 |
xxxxxxxxxxxx |
XX |
231-711-6 |
7696-12-0 |
|
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x |
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439 |
xxxxxxx xxxxxx |
XX |
231-765-0 |
7722-84-1 |
x |
x |
x |
x |
x |
x |
|
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x |
x |
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444 |
7x-xxxxxxxxxxxx-1X,3X,5X-xxxxxxx[3,4-x]xxxxxx (XXXX) |
XX |
231-810-4 |
7747-35-5 |
|
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|
x |
|
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x |
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450 |
xxxxxxxx xxxxxxxx |
SE |
231-853-9 |
7761-88-8 |
x |
|
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453 |
peroxodisíran xxxxx |
XX |
231-892-1 |
7775-27-1 |
|
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x |
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455 |
xxxxxxxx xxxxxxxx |
XX |
231-908-7 |
7778-54-3 |
|
x |
x |
x |
x |
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x |
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457 |
xxxxx |
XX |
231-959-5 |
7782-50-5 |
|
x |
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|
x |
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x |
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458 |
xxxxx xxxxxx |
XX |
231-984-1 |
7783-20-2 |
|
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x |
x |
|
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473 |
xxxxxxxxxx x xxxxxxxxxxx |
ES |
232-319-8 |
8003-34-7 |
|
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|
x |
x |
|
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|
491 |
xxxx xxxxxxxxxx |
XX |
233-162-8 |
10049-04-4 |
|
x |
x |
x |
x |
|
|
|
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|
x |
x |
|
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|
494 |
2,2-xxxxxx-2-xxxxxxxxxxxx (XXXXX) |
XX |
233-539-7 |
10222-01-2 |
|
x |
|
x |
|
x |
|
|
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|
x |
x |
x |
|
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|
501 |
xxxxxxxxxxx |
XX |
234-232-0 |
10605-21-7 |
|
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|
x |
|
x |
x |
|
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|
515 |
xxxxxx xxxxxx |
SE |
235-183-8 |
12124-97-9 |
|
|
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|
x |
x |
|
|
|
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|
522 |
zink-1-oxo-1λ5-pyridin-2-thiolát |
XX |
236-671-3 |
13463-41-7 |
|
x |
|
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|
x |
x |
|
x |
x |
|
|
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|
x |
|
|
524 |
xxxxxxxxxxxxxxx-xxxxxxxxxxxxxxxx |
ES |
237-030-0 |
13590-97-1 |
|
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|
x |
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|
x |
|
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526 |
xxxxxx-xxxxxxx-2-xxxx |
XX |
237-243-9 |
13707-65-8 |
|
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|
x |
|
|
x |
x |
|
|
x |
|
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|
529 |
xxxxxxxxxxxxxxx |
XX |
237-601-4 |
13863-41-7 |
|
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x |
|
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|
531 |
(xxxxxxxxx)xxxxxxxx |
XX |
238-588-8 |
14548-60-8 |
|
|
|
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|
x |
|
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|
x |
|
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|
534 |
xxx(1-xxxxxxxxxxxxxx-2(1X)-xxxxxxxx-X,X)xxxxxxx xxxxxxx (xxxxxxxxx xxxx) |
XX |
238-984-0 |
14915-37-8 |
|
|
|
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|
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|
x |
|
|
541 |
xxxxxxx-4-xxxxx-3-xxxxxxxxxxxxx |
FR |
239-825-8 |
15733-22-9 |
x |
x |
x |
|
|
x |
|
|
x |
|
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|
x |
|
|
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|
550 |
5,5′-xxx(4-xxxxxxxxxx)-1,1′-(xxxxx-1,6-xxxx)xxx(xxxxxxxx)-xxx(x-xxxxxxxx) (XXXX) |
PT |
242-354-0 |
18472-51-0 |
x |
x |
x |
|
|
|
|
|
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|
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|
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|
|
554 |
4-[(dijodmethyl)sulfonyl]-1-methylbenzen |
UK |
243-468-3 |
20018-09-1 |
|
|
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|
|
|
559 |
[(xxxxxxxxxxxx-2-xx)xxxxxxxx]xxxxxx-xxxxxxxxxx (XXXXX) |
X |
244-445-0 |
21564-17-0 |
|
|
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
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|
|
562 |
[2-xxxxxx-4-xxx-3-(xxxx-2-xx-1-xx)xxxxxxxxx-2-xx-1-xx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (xxxxxxxxxxx) |
EL |
245-387-9 |
23031-36-9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
563 |
xxxxxx-(X,X)-xxxx-2,4-xxxxxxx (xxxxxx xxxxxxxx) |
XX |
246-376-1 |
24634-61-5 |
|
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
|
|
566 |
α, α′,α′′-xxxxxxxxxxxxxxxxxx-1,3,5-xxxxxxx-1,3,5-xxxxxxxxxx (XXX) |
AT |
246-764-0 |
25254-50-6 |
|
x |
|
|
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
|
571 |
2-oktyltetrahydroisothiazol-3-on (OIT) |
UK |
247-761-7 |
26530-20-1 |
|
|
|
|
|
x |
x |
|
x |
x |
x |
|
x |
|
|
|
|
|
|
577 |
dimethyl(oktadecyl)[3-(trimethoxysilyl)propyl]amonium-chlorid |
XX |
248-595-8 |
27668-52-6 |
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
|
578 |
N2-terc-butyl-N4-cyklopropyl-6-(methylsulfanyl)-1,3,5-triazin-2,4-diamin (xxxxxxxx) |
XX |
248-872-3 |
28159-98-0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
588 |
xxxxxxxxx-5,5-xxxxxxxxxxxxxxxxxxxx-2,4-xxxx (XXXXX/xxxxxxxxxxxxxxxxxxxxxxxxxx) |
XX |
251-171-5 |
32718-18-6 |
|
x |
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
|
590 |
3-(4-xxxxxxxxxxxxxx)-1,1-xxxxxxxxxxxxxxxx/xxxxxxxxxxx |
XX |
251-835-4 |
34123-59-6 |
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
|
|
|
|
|
597 |
1-[2-(allyloxy)-2-(2,4-dichlorfenyl)ethyl]imidazol (imazalil) |
XX |
252-615-0 |
35554-44-0 |
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
599 |
X-[(6-xxxxx-2-xxxxxxxxxx[4,5-x]xxxxxxx-3(2X)-xx)xxxxxx]-X,X-xxxxxxxx-xxxxxxxxxxxxx (xxxxxxxxxxx) |
XX |
252-626-0 |
35575-96-3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
600 |
2-xxxx-2-(xxxxxxxxxx)xxxxxxxxxxxxxx (XXXXX) |
CZ |
252-681-0 |
35691-65-7 |
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x |
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961 |
xxxx vápenato-hořečnatý/dolomitické xxxxx |
XX |
253-425-0 |
37247-91-9 |
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x |
x |
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962 |
xxxxxxxx vápenato-hořečnatý/hydratované xxxxxxxxxxx xxxxx |
XX |
254-454-1 |
39445-23-3 |
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x |
x |
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606 |
[(3-xxxxxxxxxxx)xxxxxxxxxx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (xxxxxxxxxxx) |
XX |
254-484-5 |
39515-40-7 |
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x |
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608 |
xxxxxxxx(xxxxxxxxxx)[3-(xxxxxxxxxxxxxxx)xxxxxx]xxxxxxx-xxxxxxx |
XX |
255-451-8 |
41591-87-1 |
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x |
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609 |
cis- a xxxxx-x-xxxxxxx-3,8-xxxx (xxxx) (xxxxxxxxxx) |
XX |
255-953-7 |
42822-86-6 |
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x |
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614 |
(XX)-α-xxxxx-3-xxxxxxxxxxxx-(1XX)-xxx,xxxxx-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
257-842-9 |
52315-07-8 |
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x |
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615 |
3-xxxxxxxxxxxx(1XX,3XX;1XX,3XX)-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (xxxxxxxxxx) |
IE |
258-067-9 |
52645-53-1 |
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x |
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x |
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618 |
[1-xxxxxxx-2-xxxxxxxxxx-2-xx-1-xx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (xxxxxxxxxx) |
XX |
259-154-4 |
54406-48-3 |
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x |
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619 |
3-xxxxxxx-2-xx-1-xx-X-xxxxxxxxxxxxx (XXXX) |
XX |
259-627-5 |
55406-53-6 |
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x |
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x |
x |
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x |
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620 |
xxxxxxxx(xxxxxxxxxxxxx)xxxxxxxxx-xxxxxx (2:1) (XXXX) |
MT |
259-709-0 |
55566-30-8 |
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x |
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x |
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x |
x |
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628 |
(±)-1-{[2-(2,4-xxxxxxxxxxxx)-4-xxxxxx- 1,3-xxxxxxxx-2-xx]xxxxxx}-1X-1,2,4-xxxxxxx (xxxxxxxxxxxx) |
FI |
262-104-4 |
60207-90-1 |
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x |
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635 |
alkyltrimethylammoniumchlorid kokosového xxxxx (XXXXX/XXXX) |
XX |
263-038-9 |
61789-18-2 |
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x |
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648 |
4,5-xxxxxxx-2-xxxxxxxxxxxxxxx-3(2X)-xx (4,5-dichlor- 2-xxxxx-2X-xxxxxxxxxx-3-xx (DCOIT)) |
X |
264-843-8 |
64359-81-5 |
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x |
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x |
x |
x |
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649 |
1-(2-chlorbenzyl)-3-[(trifluormethoxy)fenyl]močovina (xxxxxxxxxxx) |
XX |
264-980-3 |
64628-44-0 |
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x |
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656 |
xxx(5-xxxxxxxxxxxxxxxx-3-xx)xxxxxx (xxxxxxxxxx/XXX) |
XX |
266-235-8 |
66204-44-2 |
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x |
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x |
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x |
x |
x |
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657 |
6-(xxxxxxxxxxxxxxxx)-1,3,5-xxxxxxx-2,4-xxxxxx (xxxxxxxxx) |
EL |
266-257-8 |
66215-27-8 |
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x |
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666 |
[(3-xxxxxx-4-xxxxxxxxxx)xxxxxxxxxx]-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxx-1-xxxxxxxxxx (xxxxxxxxxx) |
DE |
269-855-7 |
68359-37-5 |
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x |
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667 |
alkyl(C12-18)dimethylbenzylammoniumchlorid (XXXXX (X12-18)) |
XX |
269-919-4 |
68391-01-5 |
x |
x |
x |
x |
|
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x |
x |
x |
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x |
|
671 |
alkyl(C12-16)dimethylbenzylammoniumchlorid (XXXXX/XXX (X12-X16)) |
XX |
270-325-2 |
68424-85-1 |
x |
x |
x |
x |
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x |
x |
x |
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x |
|
673 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxxx (XXXX) (X8-10) |
XX |
270-331-5 |
68424-95-3 |
x |
x |
x |
x |
|
x |
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x |
x |
x |
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|
690 |
alkyl(C12-C18)benzyl(dimethyl)amoniové xxxx 1,1-xxxxx-1λ-1,2-xxxxxxxxxxxxxxx-3(2X)-xxx (ADBAS) |
MT |
273-545-7 |
68989-01-5 |
|
x |
|
x |
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|
691 |
natrium-N-(hydroxymethyl)glycinát |
XX |
274-357-8 |
70161-44-3 |
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x |
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692 |
xxxxx(X10-X16)xxxxxxxxxxxxxxxxx |
XX |
274-687-2 |
70592-80-2 |
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x |
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693 |
bis(peroxosíran)-bis(síran) xxxxxxxxxxxxx |
XX |
274-778-7 |
70693-62-8 |
|
x |
x |
x |
x |
|
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701 |
xxxxxxxxx-xxxxxxxxxxxxxxxx xxxxxxxxxx (MMPP) |
XX |
279-013-0 |
84665-66-7 |
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x |
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1015 |
margosa, Xxxxxxxxxxx xxxxxx, xxxxxxx |
XX |
283-644-7 |
84696-25-3 |
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x |
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724 |
xxxxx(X12-X14)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXX (C12-C14)) |
XX |
287-089-1 |
85409-22-9 |
x |
x |
x |
x |
|
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x |
x |
x |
|
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x |
|
725 |
alkyl(C12-C14)ethylbenzylammoniumchlorid (ADEBAC (X12-X14)) |
XX |
287-090-7 |
85409-23-0 |
x |
x |
x |
x |
|
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x |
x |
x |
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x |
|
731 |
xxxxxxxxx xxxxxxxxxxxx, Chrysanthemum xxxxxxxxxxxxxxxx, xxxxxxx |
ES |
289-699-3 |
89997-63-7 |
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x |
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744 |
xxxxxxxxx xxxxxx, Xxxxxxxxx xxxxxxx, výtažek/levandulový xxxx |
XX |
294-470-6 |
91722-69-9 |
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x |
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776 |
1-[3,5-xxxxxxx-4-(1,1,2,2-xxxxxxxxxxxxxxxx)xxxxx]-3-(2,6-xxxxxxxxxxxxxx)xxxxxxxx (xxxxxxxxxxxx) |
XX |
401-400-1 |
86479-06-3 |
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x |
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779 |
xxxxxxx xxxxxxxx xxxxxxxxx kyseliny a X-xxxxx(X12-X14)xxxxxx-1,2-xxxxxxx (xxxxxxxxxxxxx) |
XX |
403-950-8 |
164907-72-6 |
|
x |
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x |
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785 |
6-xxxxxxxxxxxxxxxxxxxxxxx xxxxxxxx (XXX) |
XX |
410-850-8 |
128275-31-0 |
x |
x |
x |
x |
|
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791 |
2-xxxxx-1,2-xxxxxxxxxxxx-3(2X)-xx (XXXX) |
CZ |
420-590-7 |
4299-07-4 |
|
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x |
x |
|
x |
x |
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x |
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792 |
komplex tetrachlordekaoxidu (XXXX) |
XX |
420-970-2 |
92047-76-2 |
x |
x |
|
x |
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811 |
xxxxxxxxxxxxxxxxxxx xxxxxxxx-xxxxx-xxxxxxxxxxx |
XX |
422-570-3 |
265647-11-8 |
x |
x |
|
x |
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x |
|
x |
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794 |
sek-butyl-2,2-(2-hydroxyethyl)piperidin-1-karboxylát (xxxxxxxx) |
XX |
423-210-8 |
119515-38-7 |
|
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x |
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797 |
1-((X)-3-xxxxxxxxxx)-3,5,7-xxxxxx-1-xxxxxxxxxxxxxxxxxxxxxx (xxx-XXXX) |
XX |
426-020-3 |
51229-78-8 |
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x |
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x |
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800 |
{[2,5-xxxxx-3-(xxxx-2-xx-1-xx)xxxxxxxxxxxx-1-xx]xxxxxx}-2,2-xxxxxxxx-3- (2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx- 1-xxxxxxxxxx (xxxx xxxxxxxxxxxxx) (xxxxxxxxxxx) |
XX |
428-790-6 |
72963-72-5 |
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x |
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|
790 |
5-chlor-2-(4-chlorfenoxy)fenol (XXXX) |
XX |
429-290-0 |
3380-30-1 |
x |
x |
|
x |
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807 |
(X)-1-[(2-xxxxxxxxxxxx-5-xx)xxxxxx]-3-xxxxxx-2-xxxxxxxxxxxxx (xxxxxxxxxxxxx) |
XX |
433-460-1 |
210880-92-5 |
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x |
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952 |
Xxxxxxxx xxxxxxxxxx 2362, xxxx XXXX-1743 |
XX |
xxxxxxxxxxxxxxx |
143447-72-7 |
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x |
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955 |
Xxxxxxxx xxxxxxxxxxxxx xxxxx. xxxxxxxxxxx, xxxx XX3X |
IT |
xxxxxxxxxxxxxxx |
xxxx xxxxxxxxxx |
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x |
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957 |
Xxxxxxxx xxxxxxxx |
XX |
xxxxxxxxxxxxxxx |
xxxx relevantní |
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x |
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928 |
5-chlor-2-methylisothiazol-3(2H)-on (Einecs 247-500-7) a 2-xxxxxxxxxxxxxxxx-3(2X)-xx (Xxxxxx 220-239-6), xxxx (3:1) (směs XXXX/XXX) |
XX |
směs |
55965-84-9 |
|
x |
|
x |
|
x |
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x |
x |
x |
|
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|
939 |
xxxxxxx xxxxx (xxxxxxxx reakcí xxxxxxxx chlorné a xxxxxxxxx xxxxxxx in xxxx) |
XX |
xxxx |
xxxx xxxxxxxxxx |
|
x |
x |
x |
x |
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|
813 |
xxxxxxxxxxxxxx kyselina |
FR |
není xxxxxxxxxx |
33734-57-5 |
|
x |
x |
x |
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1014 |
xxxxxxxx zeolit |
SE |
není xxxxxxxxxx |
není xxxxxxxxxx |
|
x |
|
x |
x |
|
x |
|
x |
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|
849 |
3-xxxxxxxxxxxx-(1X,3XX)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (d-fenothrin) |
XX |
xxxx xxxxxxxxxx |
188023-86-1 |
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x |
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|
931 |
alkyltrimethylendiaminy, X-X12-14(xx xxxxx xxxxxx), xxxxxxxx reakce x xxxxxxxxxxxx kyselinou (Xxxxxxxx 20) |
XX |
xxxx xxxxxxxxxx |
139734-65-9 |
|
x |
x |
x |
|
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|
152 |
xxxxxxxx xxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-xxxxx-5-xxxxxxxxxxxxxxxx x xxxxxx x xxxxxxx (XXXXX) |
XX |
xxxx x xxxxxxxxx |
xxxx k dispozici |
|
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x |
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459 |
xxxxxxx xxxx xxxxx xxxxxxxxxxxx x chloridu xxxxxxxxxx |
XX |
xxxx x xxxxxxxxx |
xxxx x xxxxxxxxx |
x |
x |
|
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|
x |
x |
|
x |
x |
x |
|
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|
777 |
reakční produkty 5,5-xxxxxxxxxxxxxxxxxx, 5-ethyl-5-methylhydantoinu s chlorem (XXXXX) |
XX |
xxxx k dispozici |
xxxx x xxxxxxxxx |
|
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x |
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810 |
fosforečnanové xxxx x obsahem xxxxxxx |
XX |
xxxx x xxxxxxxxx |
308069-39-8 |
|
x |
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x |
|
x |
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|
824 |
xxxxxxxx-xxxxxxxxx zeolit |
XX |
xxxx x xxxxxxxxx |
130328-20-0 |
|
x |
|
x |
x |
|
x |
|
x |
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|
1013 |
xxxxxxxx-xxxxxxx xxxxxx |
XX |
není x xxxxxxxxx |
130328-19-7 |
|
x |
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x |
x |
|
x |
|
x |
|
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1017 |
xxxxxxx xxxxxxxxxxx xx oxidu xxxxxxxxxx (xxxx xxxxxxxxxxxx xx xxxxx xxxxxxxxxx agregátu x xxxxxxxxxx xxxxxxxxx xx xxxxxxxxxx) |
SE |
xxxx x xxxxxxxxx |
není x xxxxxxxxx |
|
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x |
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1019 |
xxxx xxxxxxxxx (xxxx xxxxxxxxxxxx xxxxxxx xxxxxxxx x xxxxxxxxxx) |
XX |
xxxx k dispozici |
68909-20-6 |
|
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x |
|
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|
831 |
xxxxxxxxx |
FR |
přípravek xx xxxxxxx xxxxxxx |
61790-53-2 |
|
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|
x |
|
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|
854 |
(XX)-3-xxxx-2-xxxxx-4-xxxxxxxxxxxx-2-xxxx-(1X,3X;1X,3X)-2,2-xxxxxxx-3-(2-xxxxxxxxx-1-xxxx)-xxxxxxxxxxxxxxxxxxxxx (xxxx 4 xxxxxxx 1X xxxxx, 1R: 1R xxxxx, 1X: 1X xxx, 1X: 1X xxx, 1S 4:4:1:1) (x-xxxxxxxxx) |
XX |
xxxxxxxxx na xxxxxxx xxxxxxx |
231937-89-6 |
|
|
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|
x |
|
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|
855 |
(XX)-3-xxxxx-2-xxxxxx-4-xxxxxxxxxxxx-2-xx-1-xx-(1X,3X)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (směs 2 xxxxxxxxxxxxx) (xxxxxxxxxx) |
XX |
xxxxxxxxx na xxxxxxx rostlin |
260359-57-7 |
|
|
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|
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|
x |
|
|
|
|
848 |
X-[(6-xxxxx-3-xxxxxxx)xxxxxx]-X′-xxxx-X-xxxxxxxxxxxxxxxxxxx (xxxxxxxxxxx) |
XX |
xxxxxxxxx xx ochranu xxxxxxx |
160430-64-8 |
|
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|
x |
|
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|
|
835 |
xxxxxxxxxxxx/(X)-(3-xxxxxxxxxxx)xxxxxxxxxx-(X)-2-(4-xxxxxxxxxx)-3-xxxxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
xxxxxxxxx na xxxxxxx xxxxxxx |
66230-04-4 |
|
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|
x |
|
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|
836 |
[(3-xxxxxxxxxxxx)xxxxxxxxxx]-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxx-1-xxxxxxxxxx (α-xxxxxxxxxxxx) |
XX |
přípravek xx xxxxxxx xxxxxxx |
67375-30-8 |
|
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|
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|
|
|
x |
|
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|
|
843 |
4-brom-2-(4-chlorfenyl)-1-(ethoxymethyl)-5-(trifluormethyl)pyrrol-3-karbonitril (xxxxxxxxxxxx) |
PT |
přípravek xx xxxxxxx xxxxxxx |
122453-73-0 |
|
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x |
|
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|
859 |
polymer X-xxxxxxxxxxxxxxxxx(XXXXXX 204-697-4) x (xxxxxxxxxxx)xxxxxxxx (XXXXXX 203-439-8)/xxxxxxxxx xxxxxxxxx chlorid xxxxxx (XX Polymer) |
XX |
xxxxxxx |
25988-97-0 |
|
x |
|
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|
x |
|
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|
|
863 |
xxxx(xxxxxxxx-1,5-xxxxxxxxx-1,6-xxxx) (PHMB) |
XX |
xxxxxxx |
27083-27-8/32289-58-0 |
x |
x |
x |
x |
x |
x |
|
|
x |
|
x |
|
|
|
|
|
|
|
|
868 |
poly(biguanid-1,5-diylhexan-1,6-diyl-hydrochlorid) |
XX |
xxxxxxx |
91403-50-8 |
x |
x |
x |
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
869 |
α-[2-(didecylmethylamonio)ethyl]-ω-[hydroxypoly(oxyethylen)-propionát] (Xxxxxx 26) |
IT |
polymer |
94667-33-1 |
|
x |
|
x |
|
|
|
x |
|
x |
|
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872 |
X-xxxxxxx-X-xxxxxxxxxxxxxxxxxxxx-xxxxx/ α, α ′-(xxxxxxxxxxxxx)xxx[ω-xxxxxxxxx(xxxxxxxxxx)]-xxx xx (polymerický xxxxxx) |
XX |
polymer |
214710-34-6 |
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x |
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XXXX 2
Xxxxxxxxx xxxxxx xxxxx x xxxx přípravku xxxxxxxxxxxxx xx xxx 4. xxxxx 2014
Tato xxxx xxxx přílohy xxxxxxxx
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kombinace xxxxx x xxxx xxxxxxxxx xxxxxxx x xxxxxxx xxxx, xxxxxx xxxxxxxxxx nanoforem, |
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jakékoli xxxxxxxxx xxxxx xxxxxxxxx xxxxx a typu přípravku xxxxxxxxx x xxxxxxx x xxxxx 1, xxxxx xxxx, xxxxx xxxx xxxxxxx x xxxxxxx, x |
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xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxxxx xx 4. srpna 2014, x xxxxxxxx těch, xxxxx xxxx xxxxxxxx schváleny. |
Xxxxxxxxx xxxxx x xxxx přípravku x xxxxxxxxxxxxx zařazené xx této části xxxxx xxxxxxxxx xxxxxxxxxx x neschválení xxxxx xxxxxx 20, jestliže xxxxx osoba nepodá xxxxxxxx xx xxxxxxxx měsíců xx xxxxxx xxxxxx xxxxxxxx v platnost podle xx. 14 odst. 3 xxxx xxxxx xx takové xxxxxxxx zamítnuto podle xx. 17 xxxx. 4 xxxx 5.
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Xxxxx položky |
Název látky |
Členský xxxx xxxxxxxxx |
Číslo XX |
Xxxxx XXX |
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2 |
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17 |
18 |
19 |
21 |
22 |
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1021 |
1,3-xxxxxxx-5,5-xxxxxxxxxxxxxxxxx (nově xxxxxxxxxx xxxxx položky 152) |
XX |
204-258-7 |
118-52-5 |
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x |
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166 |
xxxxxx(xxxxxxxxx)xxxxxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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204-526-3 |
122-18-9 |
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167 |
benzyl(dimethyl)oktadecylamonium-chlorid (xxx xxxxxxx 948) |
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204-527-9 |
122-19-0 |
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213 |
xxxxxx(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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205-351-5 |
139-07-1 |
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214 |
benzyl(dimethyl)tetradecylamonium-chlorid (xxx xxxxxxx 948) |
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205-352-0 |
139-08-2 |
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227 |
2-(xxxxxxx-4-xx)xxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
205-725-8 |
148-79-8 |
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x |
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331 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxx (xxx položka 949) |
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219-234-1 |
2390-68-3 |
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384 |
xxxxxxxx(xxxxxxx)xxxxxxx-xxxxxxx (xxx xxxxxxx 949) |
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226-901-0 |
5538-94-3 |
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399 |
xxxxxx(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxx (xxx xxxxxxx 948) |
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230-698-4 |
7281-04-1 |
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401 |
xxxxxxx |
XX |
231-131-3 |
7440-22-4 |
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x |
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418 |
xxxx křemičitý xxxxxxx |
FR |
231-545-4 |
7631-86-9 |
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x |
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449 |
xxxxx xxxxxxx |
XX |
231-847-6 |
7758-98-7 |
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x |
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1016 |
xxxxxxx xxxxxxxx |
SE |
232-033-3 |
7783-90-6 |
x |
x |
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x |
x |
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x |
x |
x |
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554 |
4-[(xxxxxxxxxxx)xxxxxxxx]-1-xxxxxxxxxxxx |
XX |
243-468-3 |
20018-09-1 |
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x |
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587 |
xxxxx(xxxxxxxx)xxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 949) |
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251-035-5 |
32426-11-2 |
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601 |
xxxxxxxxxxxxxx(xxxxxxx-9-xx-1-xx)xxxxxxx-xxxxxxx (viz xxxxxxx 948) |
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253-363-4 |
37139-99-4 |
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615 |
3-fenoxybenzyl(1RS,3RS;1RS,3SR)-3-(2,2-dichlorvinyl)-2,2-dimethylcyklopropankarboxylát (xxxxxxxxxx) |
XX |
258-067-9 |
52645-53-1 |
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x |
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637 |
xxxxx(xxxxxx)xxxxxxxxxxxxxxx-xxxxxxxx (xxxxx xxxxxxx xx xxxxxxxx kyselin kokosového xxxxx) (viz xxxxxxx 948) |
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263-080-8 |
61789-71-7 |
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638 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxxx xxxxxxx xx mastných xxxxxxx xxxxxxxxxx oleje) (xxx xxxxxxx 949) |
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263-087-6 |
61789-77-3 |
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639 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (alkyl xxxxxxx xx xxxxxxxxxxxxxxx xxxxxxxx xxxxxxx xxxx) (xxx položka 949) |
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263-090-2 |
61789-80-8 |
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647 |
xxxxx(X8-X18)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxx xxxxxxx 948) |
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264-151-6 |
63449-41-2 |
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668 |
xxxxxxx(X6-X12)xxxxxxxxxxxxxxx-xxxxxxxx (xxx položka 949) |
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269-925-7 |
68391-06-0 |
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670 |
xxxxx(X8-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxx položka 948) |
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270-324-7 |
68424-84-0 |
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689 |
xxxxx(X10-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxx položka 948) |
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273-544-1 |
68989-00-4 |
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692 |
alkyl(C10-C16)dimethylaminoxidy |
PT |
274-687-2 |
70592-80-2 |
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x |
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697 |
dialkyl(C8-C18)dimetylamonium-chloridy (xxx položka 949) |
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277-453-8 |
73398-64-8 |
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1000 |
xxxxxxxxxx-xxx(xxxxxxxxxxxxxxxxx)xxxxxxxx xxxxxxxxxx |
XX |
279-013-0 |
14915-85-4 |
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x |
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998 |
xxxxxxx xxxxxxx xxxx xxx x xxxxx xxxxxxxx Xxxxxxxxxxx xxxxxx xxxxxxxxxxx xxxxx x xxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxxxxx |
XX |
283-644-7 |
84696-25-3 |
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x |
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741 |
xxxxx(X8-X18)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxx (xxx položka 948) |
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293-522-5 |
91080-29-4 |
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1020 |
1,3-xxxxxxx-5-xxxxx-5-xxxxxxxxxxxxxxxxxx-2,4-xxxx (xxxx definovaný xxxxx xxxxxxx 777) |
XX |
401-570-7 |
89415-87-2 |
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x |
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778 |
1-(4-xxxxxxxxxx)-4,4-xxxxxxxx-3-[(1X-1,2,4-xxxxxxx-1-xx)xxxxxx]xxxxxx-3-xx (xxxxxxxxxxx) |
XX |
403-640-2 |
107534-96-3 |
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x |
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805 |
xxxxxxx produkt xxxxxxxx-xxxxxxx, xxxxxxxx-xxxxxxxxx x xxxxxxxx-xxxxxxxxx x peroxidem vodíku (xxxxxxxx) |
XX |
432-790-1 |
xxxx relevantní |
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x |
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923 |
xxxxx(xxxxxx)xxxxxxxxxxxxxxx-xxxxxxx/xxxxxxxxxxxx-xxxxxxx (viz xxxxxxx 948) |
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xxxx |
8001-54-5 |
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949 |
(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx xxxx -methyl-sulfáty) (xxxxxx (X6-X18) nasycené a xxxxxxxxxx, odvozené xx xxxxxxxx xxxxxxx xxxx, xxxxxxxxxx xxxxx x xxxxxxxx xxxxx) (DDAC) |
XX |
xxxx xxxxx xxxxxxxxx x xxxxxxx EINECS |
xxxx relevantní |
x |
x |
x |
x |
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x |
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x |
x |
x |
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950 |
alkyltrimethylamonium-chloridy, -xxxxxxx xxxx -methyl-sulfáty) (xxxxxx (X8-X18) xxxxxxxx x nenasycené, odvozené xx xxxxxxxx xxxxxxx xxxx, xxxxxxxxxx xxxxx x sójového xxxxx) (XXXX) |
XX |
xxxx xxxxx xxxxxxxxx x seznamu EINECS |
xxxx xxxxxxxxxx |
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x |
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948 |
xxxxxx(xxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -bromidy nebo -xxxxxxxxx) (xxxxxx (C8-C22) xxxxxxxx a xxxxxxxxxx, xxxxxxxx xx mastných xxxxxxx xxxx, kokosového xxxxx x xxxxxxxx xxxxx) (XXX) |
XX |
xxxx xxxxx xxxxxxxxx x xxxxxxx XXXXXX |
není xxxxxxxxxx |
x |
x |
x |
x |
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x |
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x |
x |
x |
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849 |
3-xxxxxxxxxxxx-(1X,3XX)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxxxxxx) |
XX |
xxxx relevantní |
188023-86-1 |
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x |
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1001 |
xxxxx(X12-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxx než xxxxx xxxxxxxxx pod položku 671) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
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x |
x |
x |
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x |
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1002 |
alkyl(C12-C18)benzyl(dimethyl)amonium-chloridy(jiné xxx xxxxx xxxxxxxxx xxx xxxxxxx 667) |
IT |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
x |
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x |
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1003 |
xxxxx(X12-X18)(xxxxxxxxxxx)xxxxxxxxxxxxxxx- chloridy (xxxx xxx xxxxx xxxxxxxxx xxx xxxxxxx 725) |
XX |
xxxx xxxxxxxxxx |
není relevantní |
x |
x |
x |
x |
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x |
x |
x |
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x |
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1005 |
xxxxx(X12-X14)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxx xxx xxxxx xxxxxxxxx xxx xxxxxxx 724) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
x |
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x |
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1006 |
fosforečnanové xxxx xxxxxxxxxx xxxxxxx, xxxxx, xxxxxx x xxx |
XX |
xxxx relevantní |
398477-47-9 |
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x |
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x |
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x |
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1009 |
xxxxxxx(X8-X10)xxxxxxxxxxxxxx-xxxxxxxx (xxxx xxx xxxxx xxxxxxxxx xxx položku 673) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
x |
x |
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x |
x |
x |
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1011 |
alkyl(trimethyl)amonium-chloridy (alkyl xxxxxxx xx xxxxxxxx xxxxxxx xxxxxxxxxx xxxxx) (xxxx xxx xxxxx xxxxxxxxx xxx xxxxxxx 635) |
XX |
xxxx xxxxxxxxxx |
xxxx relevantní |
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x |
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1012 |
hlinitokřemičitan xxxxx, stříbrný a xxxxxxxxx xxxxxxx/xxxxxxxx-xxxxxxxxx xxxxxx |
SE |
není xxxxxxxxxx |
130328-20-0 |
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x |
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x |
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x |
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598 |
(±)-1-(β-xxxxxxxx-2,4-xxxxxxxxxxxxxxxxx)xxxxxxxx (xxxxxxxx xxxxxxxxx) |
DE |
xxxxxxxxx xx xxxxxxx xxxxxxx |
73790-28-0 |
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x |
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XXXXXXX XXX
Xxxxx
|
Xxxx přípravků |
Xxxxx xxx xxxxxxxxxx xxxxxxxxx zprávy xxxxx xx. 6 xxxx. 3 xxxx. x) |
Xxxxx xxx xxxxxxxx xxxxxxxx stanoviska xxxxx xx. 7 xxxx. 2 písm. b) |
|
8, 14, 16, 18, 19 a 21 |
31.12.2015 |
31.3.2016 |
|
3, 4 x 5 |
31.12.2016 |
31.3.2017 |
|
1 x 2 |
31.12.2018 |
31.3.2019 |
|
6 a 13 |
31.12.2019 |
31.3.2020 |
|
7, 9 x 10 |
31.12.2020 |
31.3.2021 |
|
11, 12, 15, 17, 20 a 22 |
31.12.2022 |
31.9.2023 |