XXXXXXXX XXXXXX V PŘENESENÉ XXXXXXXXX (XX) č. 1062/2014
xx xxx 4. xxxxx 2014,
xxxxxxxx xx xxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx všech xxxxxxxxxxx xxxxxxxx látek obsažených x xxxxxxxxxx přípravcích, které xxxx uvedeny x xxxxxxxx Xxxxxxxxxx parlamentu x Xxxx (EU) x. 528/2012
(Text x xxxxxxxx xxx XXX)
XXXXXXXX XXXXXX,
x xxxxxxx xx Xxxxxxx o fungování Xxxxxxxx xxxx,
x xxxxxxx na xxxxxxxx Evropského xxxxxxxxxx x Xxxx (XX) x. 528/2012 ze xxx 22. května 2012 o xxxxxxxx xxxxxxxxxx přípravků xx xxx x xxxxxx xxxxxxxxx (1), x xxxxxxx xx čl. 89 xxxx. 1 xxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx,
xxxxxxxx x xxxxx důvodům:
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(1) |
Nařízení Xxxxxx (XX) x. 1451/2007 (2) xxxxxxx xxxxxxxxx xxxxxxxx xxx program přezkumu xxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx (xxxx xxx „xxxxxxx přezkumu“), který xxx zahájen x xxxxxxx x xx. 16 xxxx. 2 směrnice Xxxxxxxxxx xxxxxxxxxx a Rady 98/8/XX (3). Xxxxxxx xxxx xxxxxxxx xxxx xxxxxxx x xxxxxxxxx xxxxxxxxx (XX) x. 528/2012, xxxx xx xxx xxxxxxxxx pravidla xxx xxxxxxxxxxx programu xxxxxxxx xxxxxxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx. |
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(2) |
Xx důležité xxxxx xxxxxxxxx xxxxxx xxxxx x typu xxxxxxxxx, xxxxx xxxxx xxx dodávány xx xxx x xxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxxxx článku 89 xxxxxxxx (XX) č. 528/2012 s výhradou xxxxxxxxxxxxxx předpisů. Xxxx xx tomu být x x případě xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx, xxxxx jsou xxxxxxxxx x programu přezkumu. |
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(3) |
Xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx xxx potraviny x xxxxxx xxxxx článku 6 xxxxxxxx (XX) č. 1451/2007, xxx xxxxxxxxxx xx xx xxx xxxxxxx xxx xxxxxxxxx x xxxxxx xxxxxxx v čl. 2 xxxx. 5 xxxx. x) xxxxxxxx (EU) x. 528/2012, měly xx xxx účinné xxxxx, xxxxx obsahuje, xxxxxxxxx x xxxxxxxx přezkumu xxx xxxxxxxxx xxx xxxxxxxxx. X xxxxxxxx xxxxxxxxxxxxxx předpisů xx xxxx xxx xxxxxx dodávání xx xxx x xxxxxxxxx xxxxxxxx xx xx xxxxxxxx xxxxxxxxx xxxxxxxxx. Xxxxxx xxxxxxxxxxx xxxxxxxxxx xx xxx vymezit, xxxxx xxxxxxxxx tohoto xxxxxxxxxx využijí. Totéž xx xxxx platit x xxxxxxxxx, xxx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx x xxxx definice xxxx xxxxxxxxx x xxxxxxxx (XX) x. 528/2012 oproti xxxxxxxx xxxxxxx xx xxxxxxxx 98/8/XX xxxx xx xxxxx xxxxxxxxxx xxxxxxxxxxx Xxxxxx xxxxxxxx x xxxxxxx s čl. 3 xxxx. 3 xxxxxxxx (EU) x. 528/2012, xxxxxxxxxxx (xxxxxxxxx rozhodnutím xx xxxx X-420/10 (4)) xxxx xxxxxxxxx xxxxxx Xxxxxx xx xxxxxxxxxxx xxxxxx xxxxxxxxx států, xxxxx se xxxxxxxx xxxxxxx. |
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(4) |
Xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxx xxxxx, xxxxx xxx xxxx xxxxxxxx do xxxxxxxx xxxxxxxx, z xxxx xxxxx xxxxxxx nebo xx z xx xxxxxx, xxxxx xxxxxxxx xx xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxx x xxxxxxxx xxxxx xxxxxxxx, mělo xx xxx x xxxxx xxxxxxxx xxxxx xxxxxxx x dodávání xx xxx xxxxxxxx xx jeho xxxxxxxxxxxx, za xxxxxxxx xxxxxxxx x xx xxxxxxxx xxxx. |
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(5) |
X xxxxx xxxxxxxxxxx x xxxxxxxxxxxx by xxx xxx xxxxxx hodnocení xxxxxxxx xxxxx x xxxxxxxx xxxxxxxx ve xxxxx xxxxxxxxxx xxxxxxx xxxxxxx x xxxxxxxx stanoveným xxx xxxxxxx předložené xxxxx xxxxxx 7 xxxxxxxx (XX) č. 528/2012 nebo xxxxx xxxxxxxxxxx nařízení Xxxxxx (EU) x. 88/2014 (5). |
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(6) |
Xxx xxxxx, které xxxxxxx xxxxxxxx xxxxxxxxx nebo xxxxxxxx xxx xxxxxxx, xx xxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxx návrh harmonizované xxxxxxxxxxx a označení látky xxxxx xx. 37 xxxx. 1 xxxxxxxx Xxxxxxxxxx parlamentu x Xxxx (XX) x. 1272/2008 (6), xxxxx xxx x xxxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxx, a zároveň by xxxx být xxxxxxxxx xxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx xxxxxxxx xx jiných xxxx xxxxx xxxxxxxxxxx xxxxxxxxxx. Xxxxxxxxx příslušný orgán xx měl xxxx xxxxxxxxxxx agenturu x xxxxxxx xxxxx, xxxxx xx splňovaly xxxxxxxx xxx xxxxx perzistentní, xxxxxxxxxxxxxxx či toxické, xxxx xxxxx, xxxxx xx xxxxx být považovány xx xxxxx x xxxxxxxxxxx xxxxxxxxxxxxxx narušení endokrinní xxxxxxxx. |
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(7) |
Xxx xxxx zajištěno, xx xxxxxxx xxxxxxxx xxxx xxxxxxxx xx xxxxxxxx data uvedeného x xx. 89 xxxx. 1 nařízení (XX) č. 528/2012, mělo xx xx hodnocení xxxxxx na xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx, x nichž xxxx příslušné xxxxx xxxxxxxxxx xx xxxxxxx xxxxxxxxxxx x xxxxxxxx (ES) x. 1451/2007 xxxx x xxxxx xxxxxxxx. Xxxxx xxxx by xx xxxx xxxxxxxx xxxxxx lhůty xxx xxxxxxxxx xxxxxxxxx, xxxxxxx xx xx xxxx xxxx x úvahu xxxxxxx, že xxxxxxx xx mohly xxx xxxxxxxxx xxxx než xxx xxxx xxxxxxxxx xxxxxx lhůt. |
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(8) |
Ohledně xxxxxxxx xx přílohy X xxxxxxxxx 7 xxxxxxxx (XX) x. 528/2012 xxxxx xxxxxx xxxxxxxxx xxxxx xxxxxxxxx na údaje. Xx xxxxx xxxxxx x xxxx xxxx xxxxxx žádosti o zařazení xx xxxxxxx xxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6. |
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(9) |
Xxx xxxxxx xx xx. 90 xxxx. 2 xxxxxxxx (EU) x. 528/2012 xxxxxxx x xxxxxx 91 xxxxxxxxx nařízení, že xxxxxxxx xxxxxxx v článku 10 xxxxxxxxx nařízení xx xxxx být relevantní xxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx ve všech xxxxxxxxx. Xx xxxxx xxxxxx xxxxx xxxxx xxxxxxxxx xxxx xxxxxxxx xx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx. |
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(10) |
Xxxxxxxxxxx účastník xxxxxxxx xxxxxxxx xx měl xxx xxxxxxx xx xx vzájemné xxxxxx xxxxxxxx ke xxxxxxxxxxx xxxxxxxxxxx nebo xxx xxxxxxxx za xxxxxxxxxxx, xx xxxxx xxxx xxxxxxx xx xxxxxxxx xxxxxxxxx x xxxxxx xxxxxxxxx xxxxxxxx x údajům, xxxxxxx xxxxx xx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx xxxxx xxxxx. |
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(11) |
Xxxxxxx xx xxxxx x xxxxxxxx xxxxxxxx dobrovolná, xxxx xx být xxxxxxxxxx xxxxxxxx xx ní xxxxxxxxx. Pokud x xxxx dojde, měli xx xxx potenciální xxxxxxxxx možnost xxxxxxx xxxxxxx, xxxxxx-xx xxxx xxxxxxxx využito xxx xxxxxx, xxxxx xxx xxxxxxx xx zpoždění xxxxxxxx xxxxxxxx, a xxxxxxxx-xx xxxxxxxx xxx xxxxxxxx na xxxx xxxxxxxxxx. |
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(12) |
Xxxxx se xxx xxxxxxxxx xxxxxx látky xxxxx, xx xxxxxxxx oficiálně xxxxxxxx xx xxxxxxxx xxxxxxxx xxxxxx neodpovídá xxxxxxxx xxxxxxxx hodnocené xxxxx, x x hodnocení xxxxx xxxxxxx xxxxxx xxxxxxx xxxxxxxx oficiálně xxxxxxxx xxxxx, xxxx by xxx xxxxx xxxx xxxxx x xxxxxxx hodnocení xxxxx xxxxxxxxx x xxxxxxx xxxxx xxxxxx, aby xxxxxxxx xxxxxxx xxxx xxxxxxxxx xxxxxxxx xxxxx. |
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(13) |
Xxxxxxx xxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx nejsou x xxxx přijetí xxxxxx xxxxxxxx xxxxxxxxxxx xxxxxx účastníkem. Xxxxx xx xxxx xxxxxxxx xxxxxxxxxxxxx, xxxxxx xxxxx xx. 4 xxxx. 4 xxxxxxxx (XX) č. 528/2012 xxxx xxxxxxxxx xxxxx xxxxxxxx, xxxxx xxx xxxx xxxxxxxx stanoveno. X xxxxxxxxx xxxxx x xxxxxxxxxxxxx by xxxx xxx xxxxx xxxxxxx xxxxxxx účast, xxxxxxx xxxxx by tyto xxxxx x xxxxxxxxxxxxx xxxxxx xxx z xxxxxxxx xxxxxxxx xxxxxxxxx. |
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(14) |
Xxx xxxx xxxxxxxxx, že xxxxx xxxxx xxxxxxxxx x xxxxxxxx xxxxxxxxxxx xxx xx xxx xxxxxx xxxxxxxx, xxxx by xxxxxxxx xxxx xxxxxxxxxxx, xxxx xx xxxxxxxx xxxxx, která ještě xxxxxx hodnocena, x xxxxxxxx xxxx xxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxx x xx, |
XXXXXXX TOTO XXXXXXXX:
KAPITOLA 1
PŘEDMĚT A XXXXXXXX
Xxxxxx 1
Předmět
Toto nařízení xxxxxxx pravidla pro xxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx x&xxxx;xxxxxx&xxxx;89 xxxxxxxx (XX) x.&xxxx;528/2012.
Xxxxxx 2
Definice
Pro xxxxx xxxxxx xxxxxxxx xx xxxxxxx xxxx xxxxxxxx:
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x) |
„rozhodnutím x neschválení“ xx xxxxxx rozhodnutí neschválit xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxx čl. 9 xxxx. 1 xxxx. x) xxxxxxxx (XX) x. 528/2012 xxxx xx. 89 xxxx. 1 třetího xxxxxxxxxxx xxxxxxxxx xxxxxxxx, xxxx xxxxxxxxx xxxxxxxxx xx xxxxxxx X xxxx IA xxxxxxxx 98/8/ES; |
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x) |
„xxxxxxxxx xxxxx x xxxx přípravku xxxxxxxxx xx xxxxxxxx xxxxxxxx“ xx xxxxxx kombinace látky x xxxx xxxxxxxxx uvedená x xxxxxxx XX, která xxxxxxx xxxx xxxxxxxx:
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|
c) |
„účastníkem“ xx xxxxxx xxxxx, xxxxx xxxxxxxxxx žádost x xxxxxxxxx látky x xxxx xxxxxxxxx zařazené xx xxxxxxxx xxxxxxxx xxxx předložila xxxxxxxx, které xxxxxxxx xxxxxxxxxx xxxxx xx. 17 xxxx. 5 tohoto nařízení, xxxx jejímž xxxxxx xxxx tato xxxxxx xxxx xxxxxxxx xxxxxxxxxx; |
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d) |
„hodnotícím xxxxxxxxxx orgánem“ xx xxxxxx příslušný orgán xxxxxxxxx xxxxx xxxxxxxxx x příloze II xxxxxx xxxxxxxx, určený x xxxxxxx s článkem 81 nařízení (XX) x. 528/2012. |
XXXXXXXX 2
XXXXXX XXXXXXXXX XXXXXXXXXXX
Xxxxxx 3
Xxxxxx x xxxxxxxxx xxxx xxxxxxxx xx xxxxxxx I xxxxxxxx (XX) x. 528/2012
1.&xxxx;&xxxx;&xxxx;Xxxxxx o schválení xx xxxxxxxx xx&xxxx;xxxxxxx I nařízení (XX) x.&xxxx;528/2012 xxxx xxxxx xxxxx xxxxxxxx, x xxxxx xxxxxxxx xxxxx xxxxxxxx x xxxxxx, xx xxxxxxxx xxxxxxxxxx podle čl. 17 xxxx.&xxxx;5 xxxxxx nařízení.
Pokud xx xxxxxx xxxx xxxxxxxx do přílohy X&xxxx;xxxxxxxx (XX) x.&xxxx;528/2012, může xx týkat xxxxx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 uvedené xxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxx uvedené x&xxxx;xxxxxxxx 1 se xxxxxxxx xxxxxxxx xx&xxxx;xxxx 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 xxxxx xxxxxxxxxxx xxxxxxxx Komise (XX) x. 564/2013 (7) x xxxxxxx xxxxxx, xxxxx xxxxxxxx nezaplatí xxxxxxxx ve lhůtě 30 dnů. X xxxx xxxxxxxxxxx informuje xxxxxxxxx i hodnotící xxxxxxxxx orgán.
2. Xx obdržení xxxxxxxx splatných xxxxx xxxxxxxxxxx nařízení (XX) x. 564/2013 přijme xxxxxxxx xxxxxx x xxxxxxxxx x tom xxxxxxxxx x xxxxxxxxx příslušný orgán, xxxxxxx uvede xxxxx xxxxxxx xxxxxxx x xxxx xxxxxxxxx xxxxxxxxxxxxx kód.
3. Xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 1 tohoto xxxxxx lze xxxxx xxxxxxx xxxxxxxxxx x xxxxxxx x xxxxxxx 77 nařízení (EU) x. 528/2012.
4. Xxxxxxxxx příslušný xxxxx informuje xxxxxxxxx x poplatku splatném xxxxx xx. 80 xxxx. 2 xxxxxxxx (XX) x. 528/2012 xx 30 xxx xxxx, xx xxxxxxxx xxxxxxx žádost, x xxxxxxx xxxxxx, pokud xxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxx 30 xxx. X xxxx xxxxxxxxxxx xxxxxxxxx účastníka x agenturu.
Xxxxxx 5
Xxxxxxxxx xxxxxxx x xxxxxxxxx nebo xxxxxxxx xx xxxxxxxxx 6 xxxxxxx 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 (EU) x. 528/2012, xxxxx xxxxxxxx údaje xxxxxxxxxx x xxxxxxx x xx. 6 xxxx. 1 a 2 xxxxxxxxx xxxxxxxx, x xxx xxxxxxxx poplatek xxxxx xx. 4 xxxx. 4, xxxxxxxxx xxxxxxxxx xxxxx xxxxxx xxxxxxx xx 30 dnů xx zaplacení xxxxxxxx.
2. Xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxx xx xxxxxxxxx dokumentaci xxxxx xxxxxxxx (ES) x. 1451/2007, xxxxx xx xxxxx nebyla xxxxxx xxxx xxxxx xxxxx xxxxxx 13 xxxxxxxxx xxxxxxxx, xxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxx xxxxxxxxxx xx 3. xxxxx 2015.
3. X xxxxxxxxx xxxxxxxxx x odstavcích 1 x 2 xxxxxxxxx xxxxxxxxx orgán neprovádí xxxxxxxxx kvality ani xxxxxxxxxxxx xxxxxxxxxxxx údajů xxxx xxxxxxxxxx.
4. Xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxx, xx xxxxxx xx xxxxxxx, xxxxx xxxxxxxxxxx, xxxx xxxxxxxxxx informace xxxx k potvrzení xxxxxxx nutné, a x předložení xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx. Xxxx xxxxx xxxxx xxxxxxxxxx 90 xxx.
Xxxxxxxx-xx xxxxxxxxx příslušný xxxxx, xx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx postačují xx xxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxx 2, xxxxxxx xxxxxx xx 30 xxx od xxxxxxxx xxxxxxxxxxxx xxxxxxxxx.
Jestliže xxxxxxxx xxxxxxxxxx xxxxxxxxx xx stanovené lhůtě xxxxxxxxxx, xxxxxxxxx xxxxxxxxx xxxxx xxxxxx xxxxxxx x xxxxxxxxx x xxxx xxxxxxxxxxx účastníka x agenturu. X xxxxxx xxxxxxxxx xx xxxxx xxxxxxxx zaplacené x xxxxxxx x xx. 80 odst. 1 x 2 xxxxxxxx (EU) x. 528/2012.
Xxx potvrzení žádosti xxxxxxxxx příslušný xxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxx, xxxxxxxx a další příslušné xxxxxx x xxxxx datum xxxxxx xxxxxxxxx.
Xxxxxx 6
Xxxxxxxxx xxxxxxx
1. Xxxxx xxxxxx xx xxxxxxx, xxxxx platí xxxxxxx x xxxxxx xxxxxxxx:
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x) |
xx-xx xxxxxx xxxxxxxxx podle xxxxxx 5; |
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x) |
xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxx dokumentaci xxxx xxxxxx podle xxxxxx 13 xxxxxxxx (XX) x. 1451/2007, xxx xxxxx xxxxxxxxxxx Xxxxxx xxxxxx xxxxxxxxxxx xxxxxx podle xx. 14 xxxx. 4 xxxxxxxxx xxxxxxxx; |
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x) |
xxxxx xxxxxxxx xxxxxxx xxxxxx x xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4 xxxx 5 xxxxxxx X xxxxxxxx (XX) x. 528/2012 podle xx. 4 xxxx. 2 x xxx xxxxxxxx poplatek xxxxx xx. 4 xxxx. 4. |
2. Xxxxxxxxx xxxxxxxxx orgán xxxxxxxx xxxxxx xxxxx xxxxxx 4 x 5 xxxxxxxx (XX) x. 528/2012 x xxxxxxxx xxx veškeré xxxxxx xx xxxxxx xxxxxxxxx xx xxxxx předložené x xxxxxxx s xx. 6 odst. 3 xxxxxxxxx xxxxxxxx x xxxxx hodnotící xxxxxx x xxxxxx xxxxx hodnocení xxxxxxxx.
3. Xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx přípravků xxxxxxxxx xxxxxxx xxxxxxxxx, xxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxx xxxxx xxxxxxxxx xxxxxx. Xxxxxxxxx xxxxxx x xxxxxx xxxxx x jedné x xxxxxx xxxx, xxxxx xxxx, xx xxxxxxx xxxxxxx:
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x) |
365 xxx po xxxxxxxxx xxxxxxxxx xxxxxxxx v odst. 1 xxxx. x), uznání xxxxxxxx xxxxxxxx v odst. 1 písm. b) xxxx xxxxxxxxx xxxxxxxx xxxxxxxxx x xxxx. 1 xxxx. x) x xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx; |
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x) |
ve xxxxx xxxxxxxxx x xxxxxxx XXX. |
4. Xxxx xxx, xxx xxxxxxxxx příslušný orgán xxxxxxxx xxx xxxxxx xxxxxxxx, umožní xxxxxxxxxxx xxxxx do 30 xxx x hodnotící xxxxxx x k xxxxxxx hodnocení písemné xxxxxxxxxx. Hodnotící příslušný xxxxx xxxx xxxxxxxxxx xxxxxxxxxxxxx xxxxxxxx zohlední x xxxxxxxxx fázi xxxxx hodnocení.
5. Pokud xx xxxxx, že jsou x xxxxxxxxx xxxxx xxxxxxxxxx xxxxxxxxx, xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx, xxx xxxx xxxxxxxxx xx xxxxxxxxx xxxxx xxxxxxxxx, x xxxxxxxxx x xxx xxxxxxxx.
Xxxxx 365 xxx xxxxxxx v odstavci 3 se xxxxxxx xx dobu xxx xxx xxxxxxxx požadavku xx dne xxxxxxxx xxxxxxxxx. Xxxxx xx xxxx xxxxxxxxxx povahou xxxxxxxxxxxx údajů xxxx xxxxxxxxxxx xxxxxxxxxx, xxxxxxxxx xxxxxxxxxx následující xxxxx:
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x) |
365 xxx x xxxxxxx, xx xx xxxxxxxxxx xxxxxxxxx xxxxxx otázek, xxxxx xxxxxx xxxxxx v xxxxx xxxxxxxx 98/8/XX xxxx x xxxxx postupů xxxxxxxxxxx xxx xxxxxxxxxxx xxxxxxx xxxxxxxx; |
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x) |
180 dní xx xxxxx xxxxxxxxx xxxxxxxxx. |
6. Xxxxx xxxxxxxxx xxxxxxxxx orgán xxxxxx, že xxxxxxxx xxxxx xxxxxxx xxxxxx xxxx xxxx zvířat xxxx xxxxxxxxx prostředí xxxxxxxxxxx x xxxxxxxxxxxxx xxxxxx xxxxxxxxxx x xxxxxxxxx biocidních xxxxxxxxx xxxxxxxxxxxx xxxxxx xxxx xxxxxxxx účinné xxxxx, xxx xxxxx xxxxxxxxxxxx x xxxxxxx s požadavky příslušných xxxxx xxxxxx II xxxx 3 xxxxxxx XX xxxxxxxx Xxxxxxxxxx xxxxxxxxxx a Xxxx (XX) x. 1907/2006 (8) a zahrne xx xx xxxxx xxxxxx.
7. X xxxxxxx xxxxxxx xx dokončení hodnocení xxxxxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xxx zbytečného xxxxxxx x xxxxxxxxxx xxx xxxxxxxxxx hodnotící xxxxxx xxxxx xxxxxxxx 3:
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a) |
xxxxxxxx xxxxx agentuře podle xx. 37 xxxx. 1 nařízení (XX) x. 1272/2008, jestliže xx xxxxxxx, že je xxxxxxx xxxxx z kritérií xxxxxxxxx v čl. 36 xxxx. 1 xxxxxxxxx xxxxxxxx, xxx xxxx xxxxxxxx řešeno x xxxxx 3 xxxxxxx XX xxxxxxxxx xxxxxxxx; |
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x) |
xxxxxxxxxx x xxxxxxxxx, xxxxx xx xxxxxxx, xx xxxxx z kritérií čl. 5 xxxx. 1 xxxx. x) xxxx x) nařízení (EU) x. 528/2012 xxxx xxxxxxxx xx. 10 xxxx. 1 písm. d) xxxxxxxxx xxxxxxxx xxxx xxxxxxx, ale nejsou xxxxxxxx řešeny v příloze XXX xxxxxxxx (XX) x. 1907/2006 nebo x xxxxxxx xxxxxxxx x xx. 59 xxxx. 1 xxxxxxxxx nařízení. |
Xxxxxx 7
Stanovisko xxxxxxxx
1. Xxxxx xxxxxx xx xxxxxxx, xxxxx xxxxx některá x xxxxxx podmínek:
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x) |
xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx xxxxxx podle xx. 6 xxxx. 2 x xxxxxxxx xxxxxxxxx návrh xxxx xxxxxxx xxxxxxxxxx xxxxx čl. 6 xxxx. 7; |
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x) |
xxxxx xxxx předložena Komisi xxxxxx příslušného xxxxxx xxxxx xx. 14 odst. 4 xxxxxxxx (ES) x. 1451/2007, xxx hodnotící zprávu xxxxx nepřezkoumal Xxxxx xxxxx pro xxxxxxxx xxxxxxxxx podle čl. 15 xxxx. 4 xxxxxxxxx xxxxxxxx. |
2. Po xxxxxxx zprávy xxxxxxxx xxxxxxxxx a předloží Xxxxxx xxxxxxxxxx x xxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxx jeho zařazení xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx X xxxxxxxx (XX) x. 528/2012, xxxxxxxx xxxxxx, s ohledem xx xxxxxx xxxxxxxxxxx příslušného xxxxxx.
Xxxxxxxx xxxxxx xxxxxxxx xxxxxxxxxx v jedné x xxxxxx xxxx, xxxxx xxxx, xx xxxxxxx xxxxxxx:
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a) |
do xxx měsíců xx xxxxxxx xxxxxx; |
|
x) |
ve xxxxx xxxxxxxxx v příloze XXX. |
Xxxxxxxx xxxxxxxx stanovisko Komisi xx 270 xxx xx xxxxxxxx xxxxxxxx.
Xxxxxx 8
Účinné látky, xxxxx xx xxxx xxxxxxxx
1. Xxx xxxxxxxx svého xxxxxxxxxx podle xx. 7 xxxx. 2 xxxxxxxx xxxxxxx, xxx xxxxxx xxxxx xxxxxxx některé z kritérií xxxxxxxxx x xx. 10 xxxx. 1 xxxxxxxx (XX) x. 528/2012, x xxxx xxxxxx xxxxx xx xxxx xxxxxxxxxx.
2. Aniž jsou xxxxxxx xxxxxx 66 x 67 xxxxxxxx (XX) x. 528/2012, xxxxx než xxxxxxxx předloží xxx xxxxxxxxxx Komisi, zveřejní xxxxxxxxx o možných xxxxxxx, xxxxx xx xxxx xxxxxxxx, během xxxxxxxxx 60 dnů; v xxxx xxxx xxxxx xxxxxxxxxx xxxxx strany xxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxxx. Agentura xxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxx x xxxxxxxxx xxxx xxxxxxxx xxxxx xxxxxxxxxx.
3. Xxxxx xx xxxxxx xxxxx xxxxxxxxx a splňuje xxxxx x xxxxxxxx stanovených x xx. 10 xxxx. 1 xxxxxxxx (XX) x. 528/2012, xxxx xxx xxxxxxxx xx xxxxx, xxxxx se má xxxxxxxx, x xxxxxxxx xxxxxxxx x xxxxxxx x xx. 89 odst. 1 xxxxxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxx.
Xxxxxx 9
Rozhodnutí Xxxxxx
Xx xxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx čl. 7 xxxx. 2 Xxxxxx xxx xxxxxxxxxx xxxxxxxx připraví xxxxx xxxxxxxxxx xxx xxxxxxx xxxxx xx. 89 xxxx. 1, xxxx xxxxxxxx podle xx. 28 xxxx. 1 nařízení (XX) x. 528/2012.
XXXXXXXX 3
XXXXX XXXXX XXXXXXXX PŘEZKUMU
Článek 10
Xxxxxxxxx xxxx nahrazení účastníků xx xxxxxxxx dohodě
1. Roli xxxxxxxxx je xxxxx xx xxxxxxxx xxxxxx xxxx xxxxxxxxxx účastníkem x potenciálním účastníkem xxxxxxx xxxx xxxxxx xx xxxxxxxxxxx, xx xx potenciální xxxxxxxx xxxxx odvolávat xx xx všechny údaje xxxxxxxxxx nebo xxxxxxx xxxxxxxxxx xxxxxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxxx xxx xxxxx xxxxxx xxxxxx xxxxxxxxxxx xxxxxxxx společně xxxxxxxxxxx a stávající xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx pro xxxxxxxx přípravky xxxxxxxxx x xxxxxx 71 xxxxxxxx (XX) č. 528/2012 (xxxx jen „xxxxxxxx“) x&xxxx;xxxxxxxx xxxx xxxxxxxxx xxxxxxx příslušná xxxxxxxx x xxxxxxxx.
3.&xxxx;&xxxx;&xxxx;Xx xxxxxxxx oznámení xxxxxxxxxxx xxxxxxxxx podle xxxxxxxx 2 xxxxxxxx aktualizuje xxxxxxxxx v rejstříku xxxxxxxx xx xxxxxxxxxx xxxxxxxxx.
4.&xxxx;&xxxx;&xxxx;Xxxxx xxxxxxx xx&xxxx;xxxxx Xxxx, xxxxx převzala xxxx xxxxxxxxx nebo se xxxxxxxxx x xxxxxxxxxxx xxxxx tohoto článku, xx xxx xxxxx xxxxxx 95 xxxxxxxx (XX) x.&xxxx;528/2012 považována xx osobu, xxxxx xxxxxxxxxx xxxxxxxxxxx nebo xxxxxxxx x xxxxxxxx x xxxxxxxxxxx.
Xxxxxx 11
Xxxxxxxxxx účastníků
1. Xx xx xx xx, xx xxxxxxxx odstoupil x xxxxxx xx xxxxxxx kombinace xxxxx x xxxx xxxxxxxxx x xxxxxxxx xxxxxxxx, v těchto xxxxxxxxx:
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x) |
xxxxx xxxxxxxxxx xxxxxxxx xxxx hodnotící příslušný xxxxx xxxxxxxxxxxxxxx rejstříku x svém xxxxxx xxxxxxxxx; |
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x) |
xxxxx xxxxxxxxxxx xxxxxx xx xxxxx xxxxxxx x xx. 3 odst. 2; |
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x) |
pokud xxxx xxxxxx byla xxxxxxxxx xxxxx xx. 4 odst. 1, xx. 4 xxxx. 4 xxxx xx. 5 odst. 4; |
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d) |
xxxxx xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxxxxxx uvedených v čl. 6 xxxx. 5; |
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x) |
xxxxx jinak xxxxxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxxxxx xxxxxx xxxx xxxxxxxx. |
2. Odstoupení xx xxxxxxxx xx xxxxxxxxx xxxx, pokud x xxxx xxxxxxx xx datu, kdy xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxx zprávu xxxxxxxxxxx orgánu podle xx. 6 xxxx. 4 xxxxxx xxxxxxxx.
Xxxxxx 12
Xxxxxxxx včasného xxxxxxxxxx
1. Xxxxx xx x xxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx, xxx nikoli xxxxxxxx, xxxxxxxxx xx hodnotící xxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxx xx x xxxxxxx odstoupení xxxxxxxxxxx xxxxxxxx, xxxxxxxxxxx xxxxxxxxx x xxxxxxxxx xxxxxxxx xx xxxxxxxxxx xxxxxxxxx.
3. Xxxxx x xxxxxxxx přezkumu xxxx xxxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx tutéž kombinaci xxxxx a typu xxxxxxxxx x xxxxx xxxx role xxxxxxxxx xxx uvedenou xxxxxxxxx dříve xxxxxxxx, xxxxxxxxx x xxx xxxxxxxx prostřednictvím xxxxxxxxx Xxxxxx.
Xxxxxx 13
Nová xxxxxxxx xxxxxxxxx xxxxx
1. Xxxxx hodnocení xxxxxxxxx účinné xxxxx xxxxxxxx xxxxxxx xxxxxx xxxxxxxx se látky, xxx jsou xxxxxxx x xxxxxxx XX, hodnotící příslušný xxxxx xx xxxxxxxxxx x dotyčným xxxxxxxxxx xxxxxxx xxxxx xxxxxxxx xxxxx. Xxxxxxxxx xxxxxxxxx xxxxx x xxx xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx x xxxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxx.
Xxxxxx 14
Xxxxxxxx role xxxxxxxxx
1. Xxxxxxxx xxxxxxxx otevřenou xxxxx x xxxxxxxx xxxx xxxxxxxxx xxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx, pokud xxxxxxx xxxxx x xxxxxx xxxxxxx:
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a) |
xxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxx látky x xxxx xxxxxxxxx včas xxxxxxxxxx xxxxx xxxxxx 11 x xxxxxx role xxxxxxxxx xxx xxxxx kombinaci xxxxxx xxxxxxx xxxxxxxx; |
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x) |
xx xxxxxxx xxxx xxxxxxxx podle xxxxxx 13; v tomto případě xx výzva týká xxxxx té xxxxx, xx xxxxxx se xxxxxxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX, xxx xxxxxxx nová xxxxxxxx látky. |
2. Do dvanácti měsíců xxx xxx xxxxxxxxxx xxxxx odstavce 1 xxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxx xxx xxxxxxxxx podle xxxxxx 17.
3. Xx xxxxxxxx měsíců od data xxxxxx xxxxxx nařízení x xxxxxxxx může xxxxxxxxx xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx xx xxxxx 2 xxxxxxx XX podle xxxxxx 17.
Xxxxxx 15
Xxxxxxxxx xxxxx x typu xxxxxxxxx xxxxxxxxx xxx zařazení xx programu xxxxxxxx
Xxxxx xxxxxxxx přípravek, xxxxx xxxxx xx xxxxxxx xxxxxxxxxx xxxxxxxx (EU) x. 528/2012 x xx xxxxxx na xxx, xxxxxxx xx xxxxxxxxx xxxxxx xxxxx, xxx xxxx xxxxxxxxx xxx xxxxxxxx do xxxxxxxx xxxxxxxx pro tento xxx xxxxxxxxx x xxxx xxxxxxxx xx xxxxxxx I xxxxxxxxx xxxxxxxx, xxxx xxxxx xxxxxxxx xxxx xx x ní xxxxxx, xx uvedená látka xxxxxxxxx xxx zařazení xx xxxxxxxx xxxxxxxx xxx xxxxxxxxx xxx xxxxxxxxx xx xxxxxxx některého x xxxxxx xxxxxx:
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x) |
xxxxx xxxxxxxxx xxxxxxx xx xxx xx spoléhala xx pokyny nebo xxxxxxx xxxxxxxxxx vydané Xxxxxx xxxx příslušným xxxxxxx xxxxxxxxxx x xxxxxxx x xxxxxxx 26 xxxxxxxx 98/8/XX xxxx xxxxxxx 81 xxxxxxxx (XX) č. 528/2012, xxxxx na základě xxxxxxxxxx xxxxxxxxxxxxxx xxxxxx xxxxx uvedené xxxxxx xx xxxxxxxxxx x xxxxxxxxxxx, xx xxxxxxx xxx xxxxx x xxxxxxxxxx směrnice 98/8/XX xxxx xxxxxxxx (XX) č. 528/2012, nebo xx xxx xxxxxxxxx xxx xxxxxxxxx xxxxxx x xxxxxxxxx, xxx xxxxx xxxx účinná xxxxx xxxxxxxx, a xxxxx xxxx xxxxxxx xxxxxx xx doporučení xxxxxxxx přezkoumány v xxxxxxxxxx xxxxxxxx xxxxx xx. 3 xxxx. 3 xxxxxxxx (XX) x. 528/2012 xxxx v nových, závazných xxxxxxxx xxxxxxxxxxxx Xxxxxx; |
|
b) |
látka xxxxxxxxx xxxxxxxx xxx xxxxxxxxx a krmiva xxxxxxxxx x xxxxxx 6 nařízení (XX) x. 1451/2007; |
|
x) |
xxxxxxxx přípravek xxxxx xxxxx xxxxxxxx (XX) x. 528/2012 k xxxxxxxxx xxxx přípravku, xxx xxxx bylo xxxxx xxxxxxxx 98/8/XX, x xxxxxxxx xxxxx xxxxxxxxxx xxxxxx xxxx přípravků x xxxxxxxx xxxxx xxxxxxxxx xx xxxxxxxx xxxxxxxx xxx xxxxxxx xxx přípravku, ale xxxxxx pro nový. |
Xxxxxx 16
Xxxxxxxxxx x xxxxx na xxxxxxxx
1. Xxxxxxxxxx x xxxxx xxxxxxx látku, xxxxx xx způsobilá xxx xxxxxxxx xx xxxxxxxx xxxxxxxx podle článku 15, předkládá prostřednictvím xxxxxxxxx xxxxxxxxx xxxxx, xxx xx xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx, xxxxxxx x xxxxxxxxxxxxx xxxxxxxx:
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x) |
Xxxxxx xxxxxxxxxx xxxxxxx měsíců xx zveřejnění xxxxxxxxxx xxxx xxxxxx uvedených x xx. 15 xxxx. x); |
|
x) |
xxxxxxxx xxxxxxxxxx 30. xxxxx 2015 x xxxxxxxxx uvedených x xx. 15 xxxx. x); |
|
c) |
Xxxxxx xxxxxxxxxx 30. října 2015 x xxxxxxxxx xxxxxxxxx v xx. 15 xxxx. x). |
2. Xxxxxxxxxx xxxx obsahovat xxxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx. X xxxxxxxxx xxxxxxxxx v čl. 15 písm. x) xxxx prohlášení xxxxxxxxx opodstatněné odůvodnění, x xxxx xxxxxxx, xx xxxx splněny xxxxxxx podmínky v xxx uvedené.
3. Pokud xxxx xxxxxxxxxx učiněno v případě xxxxxxxx v čl. 15 písm. x) nebo x) x Xxxxxx dospěje po xxxxxxxxxx x xxxxxxxxx xxxxx x xxxxxx, xx xxxxxxxx 6 xxxx xxxxxxxxxx, a případně, xx xxxx xxxxxxx xxxxxxxx xxx oznámení uvedené x xx. 15 xxxx. a), xxxxxxx o tom xxxxxxxx.
4. Xxxxx xxxx xxxxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 xxxx. b) xxxx xxxxx Xxxxxx xxxxxxxxxxx xxxxxxxx podle xxxxxxxx 3, zveřejní xxxxxxxx xxxx xxxxxxxxx elektronickými xxxxxxxxxx s uvedením xxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx. Pro účely xxxxxx nařízení xx xxxxxxxxxx xxxxx čl. 3a xxxx. 3 třetího pododstavce xxxxxxxx (XX) x. 1451/2007 xxxxxxxx xx xxxxxxxxxx xxxxx tohoto xxxxxxxx.
5. Kterákoli xxxxx, xxxxx xx xxxxx xxxxxxx kombinaci xxxxx x typu xxxxxxxxx, tak může xxxxxx xxxxx xxxxxx 17 xx xxxxx xxxxxx xxx xxx xxxxxxxxxx xxxxx xxxxxxxx 4.
6. V případech xxxxxxxxx v xx. 15 xxxx. x) x x) se xxxxxxxxx xxxxx a typu xxxxxxxxx považuje xx xxxxxxxxx účastníkem x xxxx xxxxxxxxx x dalšímu xxxxxxxx, xxxxx xxxx xxxxxxx xxxx podmínky:
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x) |
příslušná xxxxxx xxxxx je xxx xxxxxxxx xx xxxxxxxx xxxxxxxx; |
|
x) |
xxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx státu xxx xxxxxxxxxx xxxxxxx xxxxx xxx xxxxxxxx xxxxxxx xxxxx, xxxxx xxxx xxxxxxxx xxx hodnocení xxxx přípravku; |
|
c) |
účastník, xxxxx xxxxxxxxx dotyčnou dokumentaci, xxxxx, xx xx xxxxx x xxxxxxx xxxx xxxxxxxxx xxxxx x xxxx přípravku. |
Xxxxxx 17
Xxxxxx oznámení
1. Oznámení xxxxx xx. 14 xxxx. 2 x 3 xxxx xx. 16 odst. 5 se xxxxxxxxxxx xxxxxxxx prostřednictvím xxxxxxxxx.
2. Xxxxxxxx xxxx xxx xxxxxxxxxx xx xxxxxxx XXXXXX. Xxxx xxxxxxxxx xxxxx xxxxxxx v xxxxxxx I.
3. Xxxxx není x xxxxxxx XX pro xxxxxxxx xxxxxxx xxxxx xxxxxx xxxxxxxxx xxxxxxxxx orgán, xxxxxxxxx xxxxxxxxxxx xxxxxxxx x xxxxx jím xxxxxxxxx xxxxxxxxxxx xxxxxx, xxxxx xx jmenován v souladu x xxxxxxx 81 xxxxxxxx (EU) x. 528/2012, a poskytne písemné xxxxxxxxx dokládající, xx xxxxxxxxx xxxxx xxxxxxxx x xxx, xx xxxxxxxxxxx xxxxxxx.
4. Xx xxxxxxxx oznámení x tom uvědomí xxxxxxxx Komisi x xxxxxxxxxxxx xxxxxxxxx o poplatcích xxxxxxxxx xxxxx xxxxxxxx (XX) x. 564/2013. Xxxxxxxx xxxxxxxxxxx neuhradí poplatky xx 30 xxx xx xxxxxxx xxxxxxx xxxxxxxxx, xxxxxxxx xxxxxxxx xxxxxxx x xxxxxxx x tom oznamovatele x Xxxxxx.
5. Xx xxxxxxxx xxxxxxxx xxxxxxxx xx 30 xxx xxxxx, xxx oznámení xxxxxxxx xxxxxxxxxx uvedeným x xxxxxxxx 2. Pokud xxxxxxxx těmto požadavkům xxxxxxxxxx, xxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxx v xxxxx 30 xxx, xxx xxx xxxxxxxx xxxxxxx xxxx opravil. Xx xxxxxxxx xxxx 30xxxxx xxxxx agentura xx 30 xxx xxx prohlásí, xx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxx 2, xxxx xxxxxxxx xxxxxxx, x xxx xxxxxxxxxx xxxxx xxxxxxxxxxxx x Xxxxxx.
6. V xxxxxxx x xxxxxxx 77 xxxxxxxx (XX) x. 528/2012 proti xxxxxxxxxxx agentury xxxxx xxxxxxxx 4 xxxx 5 podat opravný xxxxxxxxxx.
7. Xxxxx oznámení xxxxxxxx xxxxxxxxxx xxxxx xxxxxxxx 5:
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a) |
v xxxxxxx, xx xxxx xxxxxxxx předloženo podle xx. 14 odst. 2 xxxx 3, agentura xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx x xxxxxxxxx xxxxxxxx se xxxxxxxxxx xxxxxxxxx x xxxxxxxx identity xxxxx; |
|
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v xxxxxxx, xx xxxxxxxx xxxx xxxxxxxxxx podle čl. 16 xxxx. 5, xxxxxxxx xxxxxxxxxx xxxxxxxxx Xxxxxx, xx xxxxxxxxxx bylo xxxxxxxx. |
Xxxxxx 18
Xxxxxxxx xx xxxxxxxx xxxxxxxx
Xxxxx xx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxxx xx xxxxxxxxx x xxxxxxx s čl. 16 xxxx. 6 xxxx xxxxx xxxxxxxx xxxxxxxxx Xxxxxx x xxxxxxxx xxxxxxxxx x xxxxxxx x xx. 17 xxxx. 7 písm. b), xxxxxx Xxxxxx xxxxxxxxx látky x xxxx přípravku do xxxxxxxx xxxxxxxx.
Xxxxxx 19
Informace x xxxxxxx, xxxxx xxxxxx xxxxxx podporovány x xxxxx programu xxxxxxxx
Xxxxx xxxxxx xx xxxxx stanovené x xx. 16 odst. 5 obdrženo xxxxx xxxxxxxx nebo xxxxx byla xxxxxxxx xxxxxxx ve xxxxxxxx xxxxxx xxxxxxx x xxxxxxxx xxxxxxxxx xxxxxxxxx podle xx. 17 xxxx. 4 xxxx 5, agentura x xxx xxxxxxxxx xxxxxxx státy xxxxxxxxxxxxxxx xxxxxxxxx a zveřejní xxxx informaci xxxxxxxxxxxxx xxxxxx.
Xxxxxx 20
Rozhodnutí Xxxxxx x látkách, které xxxxxx xxxxxx podporovány x xxxxx xxxxxxxx xxxxxxxx
Xxxxxx xxxxxxxx xxxxx xxxxxxxxxx x xxxxxxxxxxx xxxxx xx. 89 odst. 1 xxxxxxx xxxxxxxxxxx nařízení (XX) č. 528/2012 v těchto xxxxxxxxx:
|
x) |
xxxxx agentura xxxxxxxxx Xxxxxx x xxxxxxx xxxxxxxxxx xxxxxxxxx xxxxx čl. 12 xxxx. 3 tohoto nařízení; |
|
x) |
pokud xxxxx xxxxx xxxxxxxx xxxxxxxx xx xxxxxxx stanovených x xx. 14 xxxx. 2 xxxx 3 xxxxxx xxxxxxxx xxxx xxxxx bylo xxxxxxxx předloženo x xxxxxxxxx xxxxx xx. 17 odst. 4 xxxx 5; |
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c) |
xxxxx xxxx xxxxxxxx předloženo xx xxxxx xxxxxxxxx x xx. 14 xxxx. 2 xxxx 3 xxxxxx xxxxxxxx a byly dodrženy xxxxxxxxx podle čl. 17 xxxx. 5 tohoto nařízení, xxx xxxxxxxx xxxxx x xxxxxxxx xxxxxxxx xxxxx xxxx xxxxxxxxx identity x xxxxxxx XX xxxxxx nařízení. |
X xxxxxxx xxxxxxxx x xxxxxx xxxxxxxxxxx xxxx. x) xx xxxxx xxxxxxxxxx o xxxxxxxxxxx vztahuje xx xxxxxx xxxxx, xx xxxxxx xx xxxxxxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX xxxxxx xxxxxxxx, xxxxx xxxxxx xxxxxxxx xxxx xxxxxxxx xxxxxxxxxx x schválení.
KAPITOLA 4
XXXXXXXXX XXXXXXXX
Xxxxxx 21
Xxxxxxxxx xxxxxxxx xxx xxxxx xxxxxxx x&xxxx;xxxxxx&xxxx;15
1.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx svého stávajícího xxxxxxx nebo praxe xxxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxxxx xxxxxxxxxx přípravku, xxxxx xxxxxxx xx xxxxxxxxx xxxxxx xxxxx uvedené x xx. 15 xxxx. x) x x), xxxx látku xxxxxxxx xxxx x xx xxxxxx. V xxxxxx xxxxxxxxx:
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x) |
xxxxx xxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;24 xxxxxx xx xxxx xxxxxx xxxxxx xxxxxxxx x&xxxx;xxxxxxxx; |
|
x) |
xxxxxxxxx xxxxxx xxxxxxxxxx přípravku xxxxx xxx dále xxxxxxxxx xx&xxxx;30 xxxxxx po 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 xxxxxxxxxx xxxxxxxxx, xxxxx xxxxxxx xx stávající xxxxxx xxxxx uvedené x xx. 15 písm. x), xxxx xxxxx xxxxxxxx xxxx x xx xxxxxx. V xxxxxx případech:
|
a) |
nesmí xxx xxxxxxxx přípravek xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;24 měsíců po xx z dále xxxxxxxxx událostí, xxxxx xxxxxxx xxxxxxx:
|
|
b) |
stávající xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx být dále xxxxxxxxx do 30 xxxxxx xx té x xxxx uvedených xxxxxxxx, xxxxx xxxxxxx xxxxxxx:
|
3.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx xxxx xxxxx dodávání na trh x&xxxx;xxxxxxxxx xxxxxxxxxx přípravku, xxxxx sestává xx xxxxxxxxx xxxxxx xxxxx xxxxxxxxxx xxxxxxxxx xxxxx xx. 16 xxxx. 4 xxx xxxxxxxxx xxx xxxxxxx, xxxx xxxxx obsahuje xxxx x ní xxxxxx. X xxxxxx případech:
|
a) |
nesmí xxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx od dvanácti xxxxxx xx datu, kdy xxxxxxxx provedla xxxxxxxxxxxx xxxxxxxxxx xxxxx článku 19 x |
|
x) |
xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxx mohou xxx xxxx využívány xx&xxxx;xxxxxxxx xxxxxx xx xxxx xxxxxxxxx zveřejnění. |
Xxxxxx 22
Xxxxxxxx použití
1. Xxxx xx xxxxxx xx. 55 xxxx. 1 xxxxxxxx (XX) x. 528/2012, xx xxxxxxxx xxxxxx xx xxxx xxxxxxxxxx o neschválení xxxxxxxxx účinné látky, xxxxx členský xxxx xxxxxxxx xxxx xxxxxxxxx xxxxxxx látku xx xxxxxxxxx x xxxxxx xxxxxxxxx x xx. 5 xxxx. 2 xxxxxx xxxxxxxxxxx xxxx. x) xxxx x) xxxxxxxx (EU) x. 528/2012, tento xxxxxxx xxxx xxxx předložit Xxxxxx xxxxxxxxxxx xxxxxx x xxxxxxxx xx xx. 89 xxxx. 2 xxxxxxx xxxxxxxxxxx uvedeného xxxxxxxx.
2. Xxxxxxxx xxxxxxx xxxx xxxxxxxx odůvodněnou xxxxxx xxxxxxxx xxxxxxxxxxxxxxx rejstříku. Xxxxx žádost xxxxxxxx xxxxxxx xxxxxxxxx, xxxxxxxx xxxxxxx xxxx xxxx xxxxxxx xxxxxxxxx xxxxxxxxx xxxxx.
3. Xxxxxxxx xxxxxxxx xxxxxx xxxx xxxxxxxx xxxxxxxxxx xxxxx elektronickými xxxxxxxxxx. Xxxxxxx státy nebo xxxx xxxxx xxxxx xxxxx xxxxxxxxxx xx xxxxx 60 dnů xx xxxxxxxxxx.
4. Xx xxxxxxx obdržených xxxxxxxxxx xxxx Xxxxxx xxxxxxx odchylku xx xx. 89 xxxx. 2 xxxxxxx xxxxxxxxxxx xxxxxxxx (XX) č. 528/2012, xxxxx xxxxxx uvádět xxxxxxxx xxxxxxxxx, jež xxxxxxxxx z xxxx xxxxx, xxxxxxxx ji xxxx x xx xxxxxxxx, na xxx xxxxxxxxxx xxxxxxxxx státu x xxxxxxxx xx x xxxxx xxxxxxxx státu x xxxxxxx x xxxxxxxxxxxxxx xxxxxxxx xxxxxxxx x x xxxxxxxx podmínek xxxxxxxx 5 x xxxxxxxxx xxxxxxx xxxxxxxx uložených Xxxxxx.
5. Xxxxxxx xxxx, jemuž xx xxxxxxxx odchylka:
|
x) |
zajistí, že další xxxxxxxxx xxxx omezeno xx xxxxxx případy x xxxxxxx dobu, kdy xxxx xxxxxx xxxxxxxx xxxxxxxx 1; |
|
x) |
xxxxxx vhodná xxxxxxxx xx xxxxxxxx xxxxx, xxx xxxxxxxx xxxxxxxxxxxx expozice xxxxxxx, xxxxxx xxxx xxxxxxxxx xxxxxxxxx; |
|
x) |
zajistí, aby xx xxxxxxx xxxxxxxxxxxx xxxxxx xxxx aby xxxx xxxx xxxx xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxx o schválení xxxxxx xxxxx x xxxxxxx xxxxxxx 7 nařízení (XX) x. 528/2012. |
XXXXXXXX 5
XXXXXXXXX XXXXXXXXXX
Xxxxxx 23
Xxxxxxx
Xxxxxxx xx xxxxxxxx (XX) č. 1451/2007.
Xxxxxx xx xxxxxxx nařízení xx xxxxxxxx za xxxxxx xx xxxx xxxxxxxx.
Xxxxxx 24
Xxxxx x xxxxxxxx
Xxxx xxxxxxxx xxxxxxxx x xxxxxxxx dvacátým xxxx xx xxxxxxxxx x Xxxxxxx xxxxxxxx Xxxxxxxx unie.
Xxxx xxxxxxxx je xxxxxxx x celém xxxxxxx x xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx xxxxxxx.
V Xxxxxxx xxx 4. srpna 2014.
Xx Xxxxxx
xxxxxxxx
José Xxxxxx XXXXXXX
(1)&xxxx;&xxxx;Xx. věst. L 167, 27.6.2012, x. 1.
(2)&xxxx;&xxxx;Xxxxxxxx Komise (ES) x. 1451/2007 xx xxx 4. xxxxxxxx 2007 o xxxxx xxxxx xxxxxxxxxxxx pracovního xxxxxxxx xxxxxxxxx x xx. 16 xxxx. 2 xxxxxxxx Evropského xxxxxxxxxx x Rady 98/8/XX o uvádění xxxxxxxxxx xxxxxxxxx xx xxx (Úř. věst. X 325, 11.12.2007, x. 3).
(3) Směrnice Xxxxxxxxxx parlamentu x Xxxx 98/8/ES xx dne 16. xxxxx 1998 x xxxxxxx biocidních xxxxxxxxx xx xxx (Úř. xxxx. X 123, 24.4.1998, s. 1).
(4)&xxxx;&xxxx;Xxxxxxxx Soudního xxxxx (xxxxxxx senátu) xx xxx 1. xxxxxx 2012 (žádost x xxxxxxxxxx x xxxxxxxxx xxxxxx: Xxxxxxxxxxx Hamburg – Xxxxxxx) – Xöxx GmbH xxxxx Xxxxx XxxX (uvádění xxxxxxxxxx přípravků xx xxx – xxxxxxxx 98/8/XX – xx. 2 odst. 1 xxxx. x) – xxxxx „xxxxxxxx xxxxxxxxx“ – xxxxxxxxx, který xxxxxxxxx xxxxxxxxxx škodlivých xxxxxxxxx, aniž je xxxx, odpuzuje xxxx xxxxxxxxxxx), X-420/10.
(5)&xxxx;&xxxx;Xxxxxxxxx nařízení Xxxxxx (XX) x.&xxxx;88/2014 ze xxx 31. ledna 2014, xxxxxx xx xxxxxxx xxxxxx xxx xxxxx xxxxxxx X&xxxx;xxxxxxxx Evropského xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;528/2012 x&xxxx;xxxxxxxx xxxxxxxxxx xxxxxxxxx na xxx x&xxxx;xxxxxx xxxxxxxxx (Xx. xxxx. X 32, 1.2.2014, x. 3).
(6)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx parlamentu x Xxxx (XX) x. 1272/2008 ze xxx 16. xxxxxxxx 2008 o xxxxxxxxxxx, xxxxxxxxxx x balení xxxxx x xxxxx, x změně a xxxxxxx směrnic 67/548/XXX x 1999/45/XX a x xxxxx xxxxxxxx (XX) č. 1907/2006 (Xx. xxxx. X&xxxx;353, 31.12.2008, x. 1).
(7)&xxxx;&xxxx;Xxxxxxxxx nařízení Xxxxxx (XX) č. 564/2013 ze xxx 18.&xxxx;xxxxxx 2013 x&xxxx;xxxxxxxxxx x&xxxx;xxxxxxxx xxxxxxxxx Xxxxxxxx xxxxxxxx xxx xxxxxxxx xxxxx xxxxx xxxxxxxx Xxxxxxxxxx parlamentu x&xxxx;Xxxx (XX) x.&xxxx;528/2012 x&xxxx;xxxxxxxx biocidních xxxxxxxxx xx trh x&xxxx;xxxxxx xxxxxxxxx (Xx.&xxxx;xxxx.&xxxx;X 167, 19.6.2013, x. 17).
(8)&xxxx;&xxxx;Xxxxxxxx Evropského xxxxxxxxxx x Rady (XX) x. 1907/2006 ze xxx 18. xxxxxxxx 2006 x registraci, xxxxxxxxx, xxxxxxxxxx x xxxxxxxxx xxxxxxxxxx xxxxx, x xxxxxxx Xxxxxxxx xxxxxxxx xxx chemické xxxxx, o změně xxxxxxxx 1999/45/XX x x xxxxxxx xxxxxxxx Xxxx (XXX) x.&xxxx;793/93, xxxxxxxx Xxxxxx (XX) x. 1488/94, xxxxxxxx Xxxx 76/769/EHS x xxxxxxx Xxxxxx 91/155/XXX, 93/67/XXX, 93/105/XX a 2000/21/XX (Xx. xxxx. X 396, 30.12.2006, x. 1).
XXXXXXX I
Xxxxxxxxx požadované xxx xxxxxxxx xxxxx xxxxxx 17
Oznámení xxxxx xxxxxx 17 xxxxxxxx xxxx xxxxxxxxx:
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1) |
xxxxx, xx xxxxx xx xxxxxxxxx xxxxxxx xxxxxx xx xxxxxx čl. 3 xxxx. 1 xxxx. x) nařízení (XX) č. 528/2012; |
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xxxxx x xxxx/xxxxxx přípravku, xx xxxxx/x xx xxxxxxxx xxxxxxxx; |
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xxxxxxxxx x xxxxx xxxxxxxx, xxxxx byly xxxxxx xxx xxxxx xxxxxxx x xxxxxxxxx xx xxxxxxxx xx xxxxxxx X xxxxxxxx (XX) x. 528/2012, xxxxx x xxxxxxxxx xxxxx xxxxxx xxxxxxxxx; |
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xxxxxxxxx xxxxxxx x xxxxxxxx
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xxxxx xxxx xxxx xxxxxxxx xxxxxxx x xxxxxxx uvedeném x xx. 15 písm. x), xxxxx, xx xxxxx xxxx xx xxxx xxxx účinná xxxxx biocidního xxxxxxxxx xxxxxxxxxxx do příslušného typu xxxxxxxxx v den xxxxxxxx xxxx xxxxxxxxxx rozhodnutí xxxx xxxxxx xxxxxxxxx xx zmíněném xxxxxxx. |
XXXXXXX XX
KOMBINACE LÁTKY X XXXX XXXXXXXXX XXXXXXXX XX XXXXXXXX PŘEZKUMU DNE 4. XXXXX 2014
XXXX 1
Xxxxxxxxx xxxxxx látky x xxxx xxxxxxxxx xxxxxxxxxxx xx dni 4. xxxxx 2014, x xxxxxxxx xxxxxxxxxx jiných xxxxxxxxxxxxx xxx těch, xxxxx xxxx xxxxxxxx uvedeny x xxxxxxxxx 1017 x 1019.
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Členský stát xxxxxxxxx |
Xxxxx ES |
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formaldehyd |
XX |
200-001-8 |
50-00-0 |
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5-{[2-(2-xxxxxxxxxxxx)xxxxxx]xxxxxx}-6- xxxxxx-1,3-xxxxxxxxxxx (xxxxxxxxxxxxxxxx/XXX) |
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200-076-7 |
51-03-6 |
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200-143-0 |
52-51-7 |
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200-431-6 |
59-50-7 |
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xxxxxxx |
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200-578-6 |
64-17-5 |
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xxxxxxxx mravenčí |
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200-579-1 |
64-18-6 |
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xxxxxx-2-xx |
XX |
200-661-7 |
67-63-0 |
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kyselina salicylová |
XX |
200-712-3 |
69-72-7 |
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propan-1-ol |
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200-746-9 |
71-23-8 |
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xxxxxxxxxxx |
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200-849-9 |
75-21-8 |
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xxxxxxxx xxxxxxxxx |
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201-069-1 |
77-92-9 |
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xxxxxxxxx xxxxxxxx/2-xxxxxxxxxxxxxxx xxxxxxxx |
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201-180-5 |
79-14-1 |
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201-186-8 |
79-21-0 |
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X-(+)-xxxxxx xxxxxxxx |
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201-196-2 |
79-33-4 |
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2-xxxxxxxxxxx-8,9-xxxxxxxxx-1,2,6,6x,12,12x-xxxxxxxxxxxxxxxxx[3,4-x]xxxx[2,3-x]xxxxxxx-6-xx (xxxxxxx) |
XX |
201-501-9 |
83-79-4 |
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symklosen |
XX |
201-782-8 |
87-90-1 |
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xxxxxxx-2-xx |
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201-993-5 |
90-43-7 |
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xxxxxxxxxxxxx/3-xxxxxxxxx-2-xxxx (xxxxxxxxxxxxx) |
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203-213-9 |
104-55-2 |
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xxxxxxxx |
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203-377-1 |
106-24-1 |
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xxxxxxx |
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203-474-9 |
107-22-2 |
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xxxx-2,4-xxxxxxx kyselina (xxxxxxxx xxxxxxx) |
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203-768-7 |
110-44-1 |
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xxxxxxxx (glutaraldehyd) |
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203-856-5 |
111-30-8 |
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154 |
xxxxxxxxx |
X |
204-385-8 |
120-32-1 |
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x |
x |
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171 |
2-xxxxxxxxxxx-1-xx |
XX |
204-589-7 |
122-99-6 |
x |
x |
|
x |
|
x |
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x |
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172 |
cetylpyridinium-chlorid/1-hexadecylpyridin-1-ium-chlorid |
XX |
204-593-9 |
123-03-5 |
|
x |
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179 |
xxxx uhličitý |
XX |
204-696-9 |
124-38-9 |
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x |
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180 |
(xxxxxxx-xxxxxxxxx) – xxxxxxx-xxxxxxxxxxxxxxx |
PT |
204-708-2 |
124-65-2 |
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x |
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185 |
xxxxxxxxxxxxxx, xxxxx xxx (sodná xxx xxxxxxxxxxxxxxx – chloramin X) – (X-xxxxx-4-xxxxxxxxxxxx-1-xxxxxxxxxx |
XX |
204-854-7 |
127-65-1 |
|
x |
x |
x |
x |
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187 |
kalium-dimethyldithiokarbamát |
UK |
204-875-1 |
128-03-0 |
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x |
|
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 |
natrium-bifenyl-2-olát |
XX |
205-055-6 |
132-27-4 |
x |
x |
x |
x |
|
x |
x |
|
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) |
XX |
205-725-8 |
148-79-8 |
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x |
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x |
x |
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235 |
xxxxxx |
XX |
206-354-4 |
330-54-1 |
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x |
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x |
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239 |
karbamonitril |
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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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 (xxxxxxxxxxxxx) |
XX |
214-118-7 |
1085-98-9 |
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x |
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x |
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289 |
thiokyanatan xxxxx |
FR |
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 xxxxx/xxxxxx xxxxx |
XX |
215-137-3 |
1305-62-0 |
|
x |
x |
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959 |
xxxx xxxxxxxx/xxxxx/xxxxxx xxxxx/xxxxxxxx xxxxx |
XX |
215-138-9 |
1305-78-8 |
|
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 |
monolinuron |
XX |
217-129-5 |
1746-81-2 |
|
x |
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330 |
X-(3-xxxxxxxxxxx)-X-xxxxxxxxxxxxx-1,3-xxxxxx (diamin) |
XX |
219-145-8 |
2372-82-9 |
|
x |
x |
x |
|
x |
|
x |
|
|
x |
x |
x |
|
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336 |
N,N′-dimethyl-2,2′-disulfandiyldibenzamid (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 |
|
x |
x |
x |
|
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|
341 |
2-methyltetrahydroisothiazol-3(2H)-on (XXX) |
XX |
220-239-6 |
2682-20-4 |
|
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x |
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x |
x |
x |
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346 |
xxxxxxx-xxxxxxxxxxxxxxxxxx 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 (XXX) |
XX |
221-106-5 |
3006-10-8 |
x |
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354 |
xxxxxxxxx |
XX |
222-182-2 |
3380-34-5 |
x |
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359 |
(xxxxxxxxxxxx)xxxxxxxxxx (xxxxxxx xxxxxxxx ethylenglykolu a xxxxxxxxxxxxxxxx (EGForm)) |
PL |
222-720-6 |
3586-55-8 |
|
x |
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x |
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x |
x |
x |
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365 |
xxxxxxx-2-xxxxx-1-xxxx, sodná xxx (xxxxxxxxx sodný) |
XX |
223-296-5 |
3811-73-2 |
|
x |
x |
|
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x |
x |
|
x |
x |
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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 (HHT) |
XX |
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 (XXXX) |
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) |
PL |
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 |
XX |
231-131-3 |
7440-22-4 |
|
x |
|
x |
x |
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x |
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403 |
měď |
FR |
231-159-6 |
7440-50-8 |
|
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x |
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405 |
xxxx xxxxxxxx |
XX |
231-195-2 |
7446-09-5 |
|
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x |
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424 |
xxxxxx xxxxx |
XX |
231-599-9 |
7647-15-6 |
|
x |
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x |
x |
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432 |
xxxxxxxx xxxxx |
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 |
xxxxxxxxxxxxx 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 |
chlor |
IT |
231-959-5 |
7782-50-5 |
|
x |
|
|
x |
|
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|
x |
|
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|
458 |
síran xxxxxx |
XX |
231-984-1 |
7783-20-2 |
|
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|
x |
x |
|
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|
473 |
pyrethriny x xxxxxxxxxxx |
ES |
232-319-8 |
8003-34-7 |
|
|
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|
|
|
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|
x |
x |
|
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|
491 |
xxxx xxxxxxxxxx |
PT |
233-162-8 |
10049-04-4 |
|
x |
x |
x |
x |
|
|
|
|
|
x |
x |
|
|
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|
|
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|
494 |
2,2-xxxxxx-2-xxxxxxxxxxxx (XXXXX) |
XX |
233-539-7 |
10222-01-2 |
|
x |
|
x |
|
x |
|
|
|
|
x |
x |
x |
|
|
|
|
|
|
501 |
xxxxxxxxxxx |
XX |
234-232-0 |
10605-21-7 |
|
|
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|
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|
x |
|
x |
x |
|
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|
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|
515 |
xxxxxx xxxxxx |
SE |
235-183-8 |
12124-97-9 |
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
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|
522 |
xxxx-1-xxx-1λ5-xxxxxxx-2-xxxxxxx |
XX |
236-671-3 |
13463-41-7 |
|
x |
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
x |
|
|
524 |
xxxxxxxxxxxxxxx-xxxxxxxxxxxxxxxx |
XX |
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 |
NL |
237-601-4 |
13863-41-7 |
|
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|
|
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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 |
bis(1-hydroxypyridin-2(1H)-thionato-O,S)měďnatý xxxxxxx (xxxxxxxxx mědi) |
XX |
238-984-0 |
14915-37-8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
541 |
natrium-4-chlor-3-methylfenolát |
FR |
239-825-8 |
15733-22-9 |
x |
x |
x |
|
|
x |
|
|
x |
|
|
|
x |
|
|
|
|
|
|
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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|
|
|
|
554 |
4-[(xxxxxxxxxxx)xxxxxxxx]-1-xxxxxxxxxxxx |
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 |
kalium-(E,E)-hexa-2,4-dienoát (xxxxxx xxxxxxxx) |
XX |
246-376-1 |
24634-61-5 |
|
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
|
|
566 |
α, α′,α′′-xxxxxxxxxxxxxxxxxx-1,3,5-xxxxxxx-1,3,5-xxxxxxxxxx (HPT) |
XX |
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 |
X2-xxxx-xxxxx-X4-xxxxxxxxxxx-6-(xxxxxxxxxxxxxx)-1,3,5-xxxxxxx-2,4-xxxxxx (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-(xxxxxxxx)-2-(2,4-xxxxxxxxxxxx)xxxxx]xxxxxxxx (imazalil) |
XX |
252-615-0 |
35554-44-0 |
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x |
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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 |
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x |
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600 |
2-xxxx-2-(xxxxxxxxxx)xxxxxxxxxxxxxx (XXXXX) |
XX |
252-681-0 |
35691-65-7 |
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x |
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961 |
xxxx xxxxxxxx-xxxxxxxxx/xxxxxxxxxxx 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 (cyfenothrin) |
EL |
254-484-5 |
39515-40-7 |
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x |
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608 |
dimethyl(tetradecyl)[3-(trimethoxysilyl)propyl]amonium-chlorid |
XX |
255-451-8 |
41591-87-1 |
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x |
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609 |
xxx- 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 |
(RS)-α-kyano-3-fenoxybenzyl-(1RS)-cis,trans-3-(2,2-dichlorvinyl)-2,2-dimethylcyklopropanekarboxylát (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-ethynyl-2-methylpent-2-en-1-yl]-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyklopropan-1-karboxylát (empenthrin) |
BE |
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) |
XX |
262-104-4 |
60207-90-1 |
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x |
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635 |
alkyltrimethylammoniumchlorid xxxxxxxxxx xxxxx (XXXXX/XXXX) |
IT |
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 (XXXXX)) |
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 (cyromazin) |
XX |
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 (cyfluthrin) |
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 |
xxxxx(X12-16)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (ADBAC/BKC (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 |
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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-dioxo-1λ-1,2-benzoisothiazol-3(2H)-onu (ADBAS) |
MT |
273-545-7 |
68989-01-5 |
|
x |
|
x |
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691 |
xxxxxxx-X-(xxxxxxxxxxxxx)xxxxxxxx |
XX |
274-357-8 |
70161-44-3 |
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x |
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692 |
alkyl(C10-C16)dimethylaminoxidy |
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 |
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x |
x |
x |
x |
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701 |
xxxxxxxxx-xxxxxxxxxxxxxxxx xxxxxxxxxx (XXXX) |
XX |
279-013-0 |
84665-66-7 |
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x |
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1015 |
margosa, Xxxxxxxxxxx xxxxxx, xxxxxxx |
DE |
283-644-7 |
84696-25-3 |
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x |
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724 |
xxxxx(X12-X14)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXX (X12-X14)) |
IT |
287-089-1 |
85409-22-9 |
x |
x |
x |
x |
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x |
x |
x |
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x |
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725 |
xxxxx(X12-X14)xxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXXX (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 (hexaflumuron) |
XX |
401-400-1 |
86479-06-3 |
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x |
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779 |
xxxxxxx produkty 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 kyselina (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) |
XX |
420-590-7 |
4299-07-4 |
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x |
x |
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x |
x |
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x |
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792 |
komplex xxxxxxxxxxxxxxxxxxx (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 |
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x |
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x |
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x |
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794 |
xxx-xxxxx-2,2-(2-xxxxxxxxxxxx)xxxxxxxxx-1-xxxxxxxxxx (ikaridin) |
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-methylprop-1-en-1-yl)cyklopropan- 1-karboxylát (xxxx xxxxxxxxxxxxx) (imiprothrin) |
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 |
Bacillus xxxxxxxxxx 2362, xxxx XXXX-1743 |
XX |
mikroorganismus |
143447-72-7 |
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x |
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955 |
Xxxxxxxx xxxxxxxxxxxxx xxxxx. xxxxxxxxxxx, xxxx XX3X |
XX |
mikroorganismus |
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-xxxxx-2-xxxxxxxxxxxxxxxx-3(2X)-xx (Einecs 247-500-7) x 2-xxxxxxxxxxxxxxxx-3(2X)-xx (Xxxxxx 220-239-6), směs (3:1) (směs XXXX/XXX) |
XX |
směs |
55965-84-9 |
|
x |
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x |
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x |
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x |
x |
x |
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939 |
aktivní xxxxx (xxxxxxxx xxxxxx xxxxxxxx chlorné a xxxxxxxxx xxxxxxx in xxxx) |
XX |
xxxx |
xxxx xxxxxxxxxx |
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x |
x |
x |
x |
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813 |
xxxxxxxxxxxxxx kyselina |
XX |
xxxx xxxxxxxxxx |
33734-57-5 |
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x |
x |
x |
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1014 |
xxxxxxxx xxxxxx |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
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x |
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x |
x |
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x |
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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) |
IE |
xxxx relevantní |
188023-86-1 |
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x |
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931 |
xxxxxxxxxxxxxxxxxxxxxxx, X-X12-14(xx sudým číslem), xxxxxxxx xxxxxx x xxxxxxxxxxxx xxxxxxxxx (Xxxxxxxx 20) |
XX |
xxxx xxxxxxxxxx |
139734-65-9 |
|
x |
x |
x |
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152 |
produkty xxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-xxxxx-5-xxxxxxxxxxxxxxxx x xxxxxx a chlorem (XXXXX) |
XX |
xxxx x xxxxxxxxx |
není x xxxxxxxxx |
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x |
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459 |
xxxxxxx xxxx xxxxx xxxxxxxxxxxx x chloridu xxxxxxxxxx |
SE |
není x xxxxxxxxx |
xxxx x xxxxxxxxx |
x |
x |
|
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x |
x |
|
x |
x |
x |
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|
777 |
reakční xxxxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-xxxxx-5-xxxxxxxxxxxxxxxx s chlorem (XXXXX) |
XX |
xxxx x xxxxxxxxx |
xxxx k dispozici |
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x |
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810 |
xxxxxxxxxxxxxx xxxx s xxxxxxx xxxxxxx |
XX |
xxxx x xxxxxxxxx |
308069-39-8 |
|
x |
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x |
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x |
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824 |
xxxxxxxx-xxxxxxxxx xxxxxx |
XX |
xxxx x xxxxxxxxx |
130328-20-0 |
|
x |
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x |
x |
|
x |
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x |
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|
1013 |
xxxxxxxx-xxxxxxx zeolit |
XX |
xxxx x xxxxxxxxx |
130328-19-7 |
|
x |
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x |
x |
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x |
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x |
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1017 |
xxxxxxx xxxxxxxxxxx xx xxxxx xxxxxxxxxx (jako xxxxxxxxxxxx xx xxxxx stabilního agregátu x xxxxxxxxxx částicemi xx xxxxxxxxxx) |
XX |
není x xxxxxxxxx |
není x xxxxxxxxx |
|
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x |
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|
1019 |
xxxx křemičitý (jako xxxxxxxxxxxx xxxxxxx agregáty x xxxxxxxxxx) |
XX |
xxxx x xxxxxxxxx |
68909-20-6 |
|
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x |
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|
831 |
křemelina |
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 izomerů 1X xxxxx, 1R: 1X xxxxx, 1X: 1X xxx, 1R: 1X xxx, 1S 4:4:1:1) (x-xxxxxxxxx) |
XX |
xxxxxxxxx xx 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 (xxxx 2 xxxxxxxxxxxxx) (esbiothrin) |
DE |
xxxxxxxxx xx xxxxxxx rostlin |
260359-57-7 |
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|
x |
|
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|
|
848 |
N-[(6-chlor-3-pyridyl)methyl]-N′-kyan-N-methylethanimidamid (xxxxxxxxxxx) |
XX |
xxxxxxxxx xx ochranu rostlin |
160430-64-8 |
|
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|
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|
|
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x |
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835 |
xxxxxxxxxxxx/(X)-(3-xxxxxxxxxxx)xxxxxxxxxx-(X)-2-(4-xxxxxxxxxx)-3-xxxxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
xxxxxxxxx xx 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-cypermethrin) |
XX |
xxxxxxxxx xx xxxxxxx xxxxxxx |
67375-30-8 |
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x |
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843 |
4-xxxx-2-(4-xxxxxxxxxx)-1-(xxxxxxxxxxxx)-5-(xxxxxxxxxxxxxx)xxxxxx-3-xxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
xxxxxxxxx xx ochranu rostlin |
122453-73-0 |
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x |
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|
859 |
polymer X-xxxxxxxxxxxxxxxxx(XXXXXX 204-697-4) x (xxxxxxxxxxx)xxxxxxxx (EINECS 203-439-8)/xxxxxxxxx xxxxxxxxx xxxxxxx amonný (XX Xxxxxxx) |
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 |
polymer |
27083-27-8/32289-58-0 |
x |
x |
x |
x |
x |
x |
|
|
x |
|
x |
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|
868 |
xxxx(xxxxxxxx-1,5-xxxxxxxxx-1,6-xxxx-xxxxxxxxxxxx) |
XX |
xxxxxxx |
91403-50-8 |
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869 |
α-[2-(xxxxxxxxxxxxxxxxxxx)xxxxx]-ω-[xxxxxxxxxxx(xxxxxxxxxx)-xxxxxxxxx] (Xxxxxx 26) |
IT |
polymer |
94667-33-1 |
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x |
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872 |
N-didecyl-N-dipolyethoxyammonium-borát/ α, α ′-(xxxxxxxxxxxxx)xxx[ω-xxxxxxxxx(xxxxxxxxxx)]-xxx xx (xxxxxxxxxxx betain) |
XX |
xxxxxxx |
214710-34-6 |
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ČÁST 2
Xxxxxxxxx xxxxxx xxxxx x xxxx přípravku nepodporované xx dni 4. xxxxx 2014
Xxxx část xxxx xxxxxxx xxxxxxxx
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xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxx v tabulce xxxx, xxxxxx případných xxxxxxxxx, |
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xxxxxxxx xxxxxxxxx všech xxxxxxxxx xxxxx a typu přípravku xxxxxxxxx x xxxxxxx x xxxxx 1, xxxxx xxxx, xxxxx xxxx xxxxxxx v tabulce, x |
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xxxxxxxx xxxxxxxxx všech xxxxxxxxx xxxxxxxx xxxxx x xxxx přípravku xxxxxxxxxxx xx 4. xxxxx 2014, x xxxxxxxx xxxx, xxxxx xxxx výslovně xxxxxxxxx. |
Kombinace xxxxx x xxxx xxxxxxxxx x xxxxxxxxxxxxx zařazené xx této xxxxx xxxxx xxxxxxxxx rozhodnutí x neschválení podle xxxxxx 20, jestliže xxxxx xxxxx xxxxxx xxxxxxxx xx xxxxxxxx měsíců xx xxxxxx xxxxxx xxxxxxxx v platnost xxxxx xx. 14 xxxx. 3 nebo xxxxx xx xxxxxx xxxxxxxx zamítnuto podle xx. 17 xxxx. 4 xxxx 5.
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Xxxxx xxxxxxx |
Xxxxx látky |
Xxxxxxx xxxx xxxxxxxxx |
Xxxxx XX |
Xxxxx XXX |
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22 |
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1021 |
1,3-xxxxxxx-5,5-xxxxxxxxxxxxxxxxx (nově xxxxxxxxxx xxxxx xxxxxxx 152) |
NL |
204-258-7 |
118-52-5 |
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x |
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166 |
benzyl(hexadecyl)dimethylamonium-chlorid (xxx xxxxxxx 948) |
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204-526-3 |
122-18-9 |
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167 |
xxxxxx(xxxxxxxx)xxxxxxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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204-527-9 |
122-19-0 |
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213 |
benzyl(dodecyl)dimethylamonium-chlorid (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 (viz xxxxxxx 949) |
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226-901-0 |
5538-94-3 |
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399 |
xxxxxx(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxx (xxx položka 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 xxxxxxxxx xxxxxxx |
FR |
231-545-4 |
7631-86-9 |
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449 |
síran xxxxxxx |
XX |
231-847-6 |
7758-98-7 |
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1016 |
xxxxxxx xxxxxxxx |
XX |
232-033-3 |
7783-90-6 |
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x |
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x |
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x |
x |
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554 |
4-[(xxxxxxxxxxx)xxxxxxxx]-1-xxxxxxxxxxxx |
UK |
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-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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637 |
alkyl(benzyl)dimethylamonium-chloridy (xxxxx xxxxxxx xx xxxxxxxx xxxxxxx kokosového xxxxx) (xxx xxxxxxx 948) |
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263-080-8 |
61789-71-7 |
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638 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (alkyl odvozen xx xxxxxxxx xxxxxxx xxxxxxxxxx xxxxx) (viz xxxxxxx 949) |
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263-087-6 |
61789-77-3 |
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639 |
dialkyl(dimethyl)amonium-chloridy (xxxxx xxxxxxx xx hydrogenovaných xxxxxxxx kyselin xxxx) (xxx xxxxxxx 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 |
dialkyl(C6-C12)dimethylamonium-chloridy (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 xxxxxxx 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 |
xxxxx(X10-X16)xxxxxxxxxxxxxxxxx |
XX |
274-687-2 |
70592-80-2 |
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x |
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697 |
dialkyl(C8-C18)dimetylamonium-chloridy (xxx xxxxxxx 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 z jader xxxxxxxx Xxxxxxxxxxx xxxxxx xxxxxxxxxxx xxxxx x xxxx zpracovaný organickými 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 (viz 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 xxxxxxxxxx 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 dimethyl-adipátu, xxxxxxxx-xxxxxxxxx x dimethyl-sukcinátu x xxxxxxxxx xxxxxx (xxxxxxxx) |
XX |
432-790-1 |
xxxx xxxxxxxxxx |
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x |
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923 |
alkyl(benzyl)dimethylamonium-chlorid/benzalkonium-chlorid (xxx xxxxxxx 948) |
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xxxx |
8001-54-5 |
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949 |
(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx xxxx -xxxxxx-xxxxxxx) (xxxxxx (X6-X18) nasycené a xxxxxxxxxx, xxxxxxxx od xxxxxxxx kyselin loje, xxxxxxxxxx xxxxx x xxxxxxxx xxxxx) (DDAC) |
XX |
xxxx xxxxx uvedených x xxxxxxx EINECS |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
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x |
x |
x |
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950 |
xxxxxxxxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx nebo -methyl-sulfáty) (xxxxxx (X8-X18) nasycené x nenasycené, odvozené xx xxxxxxxx xxxxxxx xxxx, kokosového xxxxx x xxxxxxxx xxxxx) (XXXX) |
XX |
xxxx xxxxx uvedených x xxxxxxx EINECS |
xxxx xxxxxxxxxx |
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x |
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948 |
xxxxxx(xxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx xxxx -xxxxxxxxx) (alkyly (X8-X22) xxxxxxxx x xxxxxxxxxx, xxxxxxxx xx xxxxxxxx xxxxxxx loje, xxxxxxxxxx xxxxx x xxxxxxxx oleje) (XXX) |
XX |
xxxx xxxxx xxxxxxxxx x seznamu EINECS |
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 |
není 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 xxxxxxx 671) |
XX |
xxxx xxxxxxxxxx |
xxxx relevantní |
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 |
xxxxx(X12-X18)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx(xxxx xxx xxxxx xxxxxxxxx xxx xxxxxxx 667) |
XX |
není xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
x |
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1003 |
xxxxx(X12-X18)(xxxxxxxxxxx)xxxxxxxxxxxxxxx- xxxxxxxx (xxxx xxx látka xxxxxxxxx xxx položku 725) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
x |
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1005 |
xxxxx(X12-X14)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxx než látka xxxxxxxxx xxx xxxxxxx 724) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
x |
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1006 |
xxxxxxxxxxxxxx xxxx xxxxxxxxxx stříbro, xxxxx, xxxxxx x xxx |
XX |
xxxx xxxxxxxxxx |
398477-47-9 |
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1009 |
xxxxxxx(X8-X10)xxxxxxxxxxxxxx-xxxxxxxx (xxxx xxx látka xxxxxxxxx xxx položku 673) |
XX |
není 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 (xxxxx xxxxxxx xx xxxxxxxx xxxxxxx xxxxxxxxxx xxxxx) (xxxx než xxxxx xxxxxxxxx xxx položku 635) |
XX |
xxxx relevantní |
není xxxxxxxxxx |
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x |
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1012 |
hlinitokřemičitan xxxxx, xxxxxxxx a xxxxxxxxx xxxxxxx/xxxxxxxx-xxxxxxxxx xxxxxx |
XX |
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 |
přípravek xx xxxxxxx xxxxxxx |
73790-28-0 |
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x |
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XXXXXXX XXX
Xxxxx
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Xxxx xxxxxxxxx |
Xxxxx xxx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx xx. 6 xxxx. 3 xxxx. x) |
Xxxxx pro xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxx xx. 7 odst. 2 písm. b) |
|
8, 14, 16, 18, 19 x 21 |
31.12.2015 |
31.3.2016 |
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3, 4 x 5 |
31.12.2016 |
31.3.2017 |
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1 x 2 |
31.12.2018 |
31.3.2019 |
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6 x 13 |
31.12.2019 |
31.3.2020 |
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7, 9 x 10 |
31.12.2020 |
31.3.2021 |
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11, 12, 15, 17, 20 x 22 |
31.12.2022 |
31.9.2023 |