XXXXXXXX KOMISE X XXXXXXXXX XXXXXXXXX (XX) x. 1062/2014
xx xxx 4. xxxxx 2014,
týkající se xxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxx x xxxxxxxxxx xxxxxxxxxxx, xxxxx xxxx xxxxxxx x xxxxxxxx Evropského xxxxxxxxxx x Xxxx (EU) x. 528/2012
(Text x xxxxxxxx xxx XXX)
XXXXXXXX KOMISE,
s ohledem xx Xxxxxxx x xxxxxxxxx Evropské xxxx,
x xxxxxxx xx xxxxxxxx Evropského xxxxxxxxxx x Rady (EU) x. 528/2012 xx xxx 22. xxxxxx 2012 x xxxxxxxx xxxxxxxxxx xxxxxxxxx na xxx x jejich xxxxxxxxx (1), x xxxxxxx xx xx. 89 xxxx. 1 xxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx,
vzhledem x xxxxx xxxxxxx:
|
(1) |
Nařízení Xxxxxx (XX) x. 1451/2007 (2) xxxxxxx xxxxxxxxx xxxxxxxx xxx xxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxxxx účinných xxxxx (dále xxx „xxxxxxx xxxxxxxx“), xxxxx xxx zahájen x xxxxxxx x xx. 16 xxxx. 2 směrnice Xxxxxxxxxx parlamentu a Rady 98/8/XX (3). Xxxxxxx tato xxxxxxxx byla xxxxxxx x xxxxxxxxx xxxxxxxxx (XX) x. 528/2012, měla xx xxx xxxxxxxxx xxxxxxxx xxx pokračování xxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx. |
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(2) |
Xx xxxxxxxx xxxxx xxxxxxxxx xxxxxx xxxxx a xxxx xxxxxxxxx, xxxxx mohou xxx xxxxxxxx xx xxx x xxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxxxx xxxxxx 89 xxxxxxxx (XX) č. 528/2012 s výhradou xxxxxxxxxxxxxx xxxxxxxx. Xxxx xx xxxx xxx x x případě xxxxxxxxx xxxxxx xxxxx x typu xxxxxxxxx, xxxxx xxxx xxxxxxxxx x programu přezkumu. |
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(3) |
Xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx xxx xxxxxxxxx x xxxxxx xxxxx xxxxxx 6 xxxxxxxx (ES) x. 1451/2007, xxx xxxxxxxxxx xx xx xxx xxxxxxx xxx potraviny x xxxxxx xxxxxxx x xx. 2 odst. 5 xxxx. x) xxxxxxxx (XX) x. 528/2012, měly xx xxx účinné xxxxx, xxxxx xxxxxxxx, xxxxxxxxx x xxxxxxxx xxxxxxxx xxx xxxxxxxxx xxx přípravku. X xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xx xxxx xxx xxxxxx dodávání xx xxx x xxxxxxxxx xxxxxxxx xx xx xxxxxxxx uvedeného xxxxxxxxx. Xxxxxx xxxxxxxxxxx prohlášení xx měl vymezit, xxxxx xxxxxxxxx xxxxxx xxxxxxxxxx využijí. Xxxxx xx xxxx platit x xxxxxxxxx, kdy xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx x xxxx xxxxxxxx xxxx xxxxxxxxx x xxxxxxxx (XX) x. 528/2012 xxxxxx xxxxxxxx xxxxxxx ve xxxxxxxx 98/8/XX nebo xx xxxxx odůvodněno xxxxxxxxxxx Komise přijatým x xxxxxxx s čl. 3 odst. 3 xxxxxxxx (XX) x. 528/2012, xxxxxxxxxxx (xxxxxxxxx xxxxxxxxxxx xx xxxx X-420/10 (4)) xxxx závaznými xxxxxx Xxxxxx či xxxxxxxxxxx xxxxxx xxxxxxxxx xxxxx, xxxxx se xxxxxxxx xxxxxxx. |
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(4) |
Xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxx xxxxx, xxxxx již xxxx xxxxxxxx do programu xxxxxxxx, x xxxx xxxxx sestává xxxx xx z xx xxxxxx, avšak současně xx používání xxxxxx xxxxxxxxxx xxxxxxxxx x xxxxxxxx xxxxx nezbytné, xxxx xx xxx x xxxxx xxxxxxxx státě použití x xxxxxxxx xx xxx xxxxxxxx xx xxxx xxxxxxxxxxxx, xx xxxxxxxx xxxxxxxx x xx xxxxxxxx xxxx. |
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(5) |
X xxxxx xxxxxxxxxxx x xxxxxxxxxxxx xx xxx xxx postup xxxxxxxxx xxxxxxxx látek x xxxxxxxx xxxxxxxx xx xxxxx xxxxxxxxxx xxxxxxx totožný x xxxxxxxx xxxxxxxxxx xxx xxxxxxx předložené xxxxx xxxxxx 7 nařízení (XX) č. 528/2012 xxxx xxxxx xxxxxxxxxxx xxxxxxxx Xxxxxx (XX) č. 88/2014 (5). |
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(6) |
Pro xxxxx, xxxxx xxxxxxx xxxxxxxx vyloučení xxxx xxxxxxxx xxx xxxxxxx, xx xxx hodnotící xxxxxxxxx xxxxx předložit xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxxxxx a označení xxxxx xxxxx čl. 37 odst. 1 xxxxxxxx Evropského parlamentu x Xxxx (ES) x. 1272/2008 (6), xxxxx xxx o xxxxxxxxx vlastnosti vzbuzující xxxxx, x xxxxxxx xx xxxx xxx xxxxxxxxx xxxxx členského xxxxx xxxxxxxxx xxxxx xxxxxxxx xx xxxxxx xxxx xxxxx xxxxxxxxxxx xxxxxxxxxx. Xxxxxxxxx xxxxxxxxx xxxxx xx xxx také xxxxxxxxxxx agenturu x xxxxxxx xxxxx, které xx xxxxxxxxx xxxxxxxx xxx xxxxx perzistentní, xxxxxxxxxxxxxxx xx xxxxxxx, xxxx xxxxx, které xx xxxxx být xxxxxxxxxx xx xxxxx x xxxxxxxxxxx xxxxxxxxxxxxxx narušení xxxxxxxxxx xxxxxxxx. |
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(7) |
Xxx xxxx xxxxxxxxx, xx xxxxxxx xxxxxxxx xxxx xxxxxxxx xx xxxxxxxx data xxxxxxxxx x xx. 89 odst. 1 xxxxxxxx (XX) x. 528/2012, xxxx xx xx xxxxxxxxx xxxxxx xx xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx, x nichž xxxx xxxxxxxxx xxxxx xxxxxxxxxx xx xxxxxxx xxxxxxxxxxx x xxxxxxxx (XX) x. 1451/2007 xxxx x xxxxx xxxxxxxx. Xxxxx toho xx xx měly xxxxxxxx xxxxxx xxxxx pro xxxxxxxxx xxxxxxxxx, přičemž xx xx xxxx xxxx x xxxxx xxxxxxx, že žádosti xx xxxxx xxx xxxxxxxxx xxxx xxx xxx xxxx uplynutím xxxxxx lhůt. |
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(8) |
Xxxxxxx zařazení xx přílohy X xxxxxxxxx 7 xxxxxxxx (XX) x. 528/2012 xxxxx xxxxxx xxxxxxxxx xxxxx xxxxxxxxx na údaje. Xx xxxxx vhodné x této xxxx xxxxxx xxxxxxx x xxxxxxxx xx uvedené xxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6. |
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(9) |
Xxx xxxxxx xx xx. 90 xxxx. 2 xxxxxxxx (XX) x. 528/2012 xxxxxxx z článku 91 xxxxxxxxx nařízení, že xxxxxxxx xxxxxxx x xxxxxx 10 xxxxxxxxx xxxxxxxx by xxxx být xxxxxxxxxx xxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx přípravků ve všech xxxxxxxxx. Xx xxxxx xxxxxx určit xxxxx xxxxxxxxx tato kritéria xx xxxxx hodnoceních xxxxxxxx xxxxx. |
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(10) |
Xxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xx měl xxx xxxxxxx xx xx xxxxxxxx dohodě xxxxxxxx xx xxxxxxxxxxx xxxxxxxxxxx xxxx xxx xxxxxxxx xx předpokladu, xx xxxxx tomu xxxxxxx xx xxxxxxxx xxxxxxxxx z důvodu xxxxxxxxx xxxxxxxx x xxxxxx, xxxxxxx xxxxx xx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx údaje znovu. |
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(11) |
Xxxxxxx xx xxxxx v programu xxxxxxxx xxxxxxxxxx, xxxx xx xxx účastníkům xxxxxxxx xx ní xxxxxxxxx. Xxxxx x xxxx xxxxx, xxxx xx mít xxxxxxxxxxx xxxxxxxxx xxxxxxx xxxxxxx xxxxxxx, xxxxxx-xx xxxx xxxxxxxx xxxxxxx xxx xxxxxx, neboť xxx xxxxxxx xx xxxxxxxx xxxxxxxx přezkumu, x xxxxxxxx-xx xxxxxxxx xxx xxxxxxxx na xxxx xxxxxxxxxx. |
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(12) |
Xxxxx se xxx xxxxxxxxx účinné xxxxx xxxxx, xx xxxxxxxx xxxxxxxxx xxxxxxxx do programu xxxxxxxx xxxxxx xxxxxxxxxx identitě xxxxxxxx xxxxxxxxx xxxxx, x x xxxxxxxxx nelze xxxxxxx xxxxxx xxxxxxx xxxxxxxx oficiálně zařazené xxxxx, xxxx by xxx xxxxx tuto xxxxx v průběhu xxxxxxxxx xxxxx xxxxxxxxx a povolit xxxxx osobám, aby xxxxxxxx podporu této xxxxxxxxx xxxxxxxx xxxxx. |
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(13) |
Xxxxxxx xxxxx xxxxxxxx xx xxxxxxxx přezkumu nejsou x době xxxxxxx xxxxxx xxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxxxx. Totéž xx týká určitých xxxxxxxxxxxxx, ačkoli xxxxx xx. 4 xxxx. 4 nařízení (XX) č. 528/2012 xxxx xxxxxxxxx xxxxx schválit, xxxxx xxx není xxxxxxxx stanoveno. X xxxxxxxxx látek x xxxxxxxxxxxxx by xxxx xxx osoby možnost xxxxxxx xxxxx, xxxxxxx xxxxx xx xxxx xxxxx x xxxxxxxxxxxxx musely xxx x xxxxxxxx xxxxxxxx vyloučeny. |
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(14) |
Xxx xxxx xxxxxxxxx, že xxxxx xxxxx xxxxxxxxx x xxxxxxxx neoprávněně xxx xx xxx xxxxxx xxxxxxxx, xxxx xx xxxxxxxx byla vyhodnocena, xxxx xx xxxxxxxx xxxxx, xxxxx ještě xxxxxx hodnocena, x xxxxxxxx xxxx xxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx údajů o xx, |
XXXXXXX TOTO XXXXXXXX:
KAPITOLA 1
XXXXXXX X XXXXXXXX
Xxxxxx 1
Předmět
Toto nařízení xxxxxxx pravidla pro xxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxx účinných xxxxx xxxxxxxxx v článku 89 nařízení (XX) x.&xxxx;528/2012.
Xxxxxx 2
Definice
Xxx účely xxxxxx nařízení se xxxxxxx tyto xxxxxxxx:
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a) |
„xxxxxxxxxxx x neschválení“ se xxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx látky x xxxx xxxxxxxxx podle xx. 9 xxxx. 1 xxxx. x) xxxxxxxx (XX) x. 528/2012 xxxx xx. 89 odst. 1 xxxxxxx xxxxxxxxxxx xxxxxxxxx nařízení, xxxx kombinaci xxxxxxxxx xx xxxxxxx I nebo XX xxxxxxxx 98/8/ES; |
|
b) |
„xxxxxxxxx xxxxx x xxxx přípravku xxxxxxxxx xx xxxxxxxx xxxxxxxx“ xx xxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxx x xxxxxxx XX, xxxxx xxxxxxx xxxx xxxxxxxx:
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|
x) |
„xxxxxxxxxx“ xx xxxxxx xxxxx, xxxxx xxxxxxxxxx xxxxxx o xxxxxxxxx látky x xxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxxx xxxxxxxxxx xxxxxxxx, které xxxxxxxx xxxxxxxxxx xxxxx xx. 17 xxxx. 5 xxxxxx nařízení, xxxx jejímž xxxxxx xxxx xxxx xxxxxx xxxx oznámení předloženo; |
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d) |
„hodnotícím xxxxxxxxxx xxxxxxx“ xx xxxxxx xxxxxxxxx orgán xxxxxxxxx xxxxx uvedeného x příloze XX xxxxxx xxxxxxxx, xxxxxx x xxxxxxx x xxxxxxx 81 nařízení (XX) x. 528/2012. |
XXXXXXXX 2
XXXXXX XXXXXXXXX XXXXXXXXXXX
Xxxxxx 3
Xxxxxx o xxxxxxxxx xxxx xxxxxxxx xx xxxxxxx X xxxxxxxx (XX) x. 528/2012
1.&xxxx;&xxxx;&xxxx;Xxxxxx x&xxxx;xxxxxxxxx či xxxxxxxx xx&xxxx;xxxxxxx I nařízení (XX) x.&xxxx;528/2012 xxxx xxxxx xxxxx účastník, x jehož xxxxxxxx xxxxx xxxxxxxx x xxxxxx, xx odpovídá xxxxxxxxxx xxxxx xx.&xxxx;17 xxxx.&xxxx;5 xxxxxx xxxxxxxx.
Xxxxx xx xxxxxx týká xxxxxxxx xx&xxxx;xxxxxxx X&xxxx;xxxxxxxx (XX) x.&xxxx;528/2012, může xx týkat xxxxx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx xxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxxxxx v odstavci 1 se xxxxxxxx xxxxxxxx xx&xxxx;xxxx xxx xx xxxxxxxxxx x&xxxx;xxxxxxx x xxxxxxxxx podle xx.&xxxx;17 odst. 5.
Xxxxxx 4
Xxxxxxx xxxxxxx
1. Agentura xxxxxxxxx účastníka x xxxxxxxx splatném xxxxx xxxxxxxxxxx nařízení Xxxxxx (XX) x. 564/2013 (7) x zamítne xxxxxx, xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx ve xxxxx 30 xxx. X xxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x hodnotící xxxxxxxxx xxxxx.
2. Po obdržení xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxxxx nařízení (EU) x. 564/2013 xxxxxx xxxxxxxx xxxxxx x xxxxxxxxx x xxx účastníka x xxxxxxxxx xxxxxxxxx orgán, xxxxxxx xxxxx xxxxx xxxxxxx žádosti x xxxx xxxxxxxxx xxxxxxxxxxxxx xxx.
3. Xxxxx xxxxxxxxxxx agentury xxxxx xxxxxxxx 1 xxxxxx xxxxxx xxx xxxxx xxxxxxx xxxxxxxxxx x xxxxxxx s xxxxxxx 77 xxxxxxxx (XX) x. 528/2012.
4. Hodnotící xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxx xxxxxxxx xxxxx čl. 80 xxxx. 2 xxxxxxxx (XX) č. 528/2012 xx 30 dnů xxxx, xx agentura xxxxxxx xxxxxx, x xxxxxxx žádost, xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxx 30 xxx. O xxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxx.
Xxxxxx 5
Potvrzení žádostí x schválení xxxx xxxxxxxx xx xxxxxxxxx 6 xxxxxxx I xxxxxxxx (XX) x. 528/2012
1. Xxxxx agentura xxxxxx xxxxx čl. 4 xxxx. 2 žádost x xxxxxxxxx xxxx zařazení xx xxxxxxxxx 6 přílohy X xxxxxxxx (EU) x. 528/2012, xxxxx obsahuje údaje xxxxxxxxxx x xxxxxxx x xx. 6 xxxx. 1 a 2 xxxxxxxxx nařízení, x xxx xxxxxxxx xxxxxxxx xxxxx xx. 4 xxxx. 4, xxxxxxxxx xxxxxxxxx xxxxx xxxxxx xxxxxxx do 30 dnů xx xxxxxxxxx xxxxxxxx.
2. Pokud xxxxxxxxx xxxxxxxxx orgán xxxxxxx od účastníka xxxxxxxxxxx xxxxx xxxxxxxx (XX) x. 1451/2007, xxxxx xx xxxxx xxxxxx xxxxxx xxxx xxxxx xxxxx xxxxxx 13 uvedeného xxxxxxxx, potvrdí hodnotící xxxxxxxxx xxxxx xxxxxx xxxxxxxxxx xx 3. xxxxx 2015.
3. X případech xxxxxxxxx x xxxxxxxxxx 1 x 2 xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx xxxxxxx xxx xxxxxxxxxxxx předložených xxxxx xxxx xxxxxxxxxx.
4. Pokud hodnotící xxxxxxxxx xxxxx xxxxxx, xx xxxxxx je xxxxxxx, sdělí xxxxxxxxxxx, xxxx xxxxxxxxxx informace xxxx k xxxxxxxxx xxxxxxx xxxxx, x x xxxxxxxxxx těchto xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx. Tato lhůta xxxxx xxxxxxxxxx 90 xxx.
Rozhodne-li xxxxxxxxx příslušný xxxxx, xx předložené xxxxxxxxxx xxxxxxxxx xxxxxxxxx ke xxxxxxx xxxxxxxxx xxxxxxxxx x odstavci 2, xxxxxxx žádost do 30 xxx xx xxxxxxxx doplňujících xxxxxxxxx.
Jestliže xxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxxxxxxxx xxxxx xxxxxxxxxx, hodnotící xxxxxxxxx xxxxx xxxxxx xxxxxxx x xxxxxxxxx o xxxx xxxxxxxxxxx účastníka x agenturu. V xxxxxx xxxxxxxxx se xxxxx xxxxxxxx xxxxxxxxx x xxxxxxx x xx. 80 odst. 1 x 2 xxxxxxxx (XX) x. 528/2012.
Xxx xxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxxx orgán xxxxxxxxxx informuje xxxxxxxxx, xxxxxxxx x xxxxx příslušné xxxxxx x xxxxx datum xxxxxx xxxxxxxxx.
Xxxxxx 6
Xxxxxxxxx xxxxxxx
1. Xxxxx xxxxxx xx xxxxxxx, xxxxx xxxxx některá x xxxxxx xxxxxxxx:
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x) |
je-li žádost xxxxxxxxx xxxxx xxxxxx 5; |
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x) |
xxxxx xxxxxxxxx příslušný xxxxx uznal xxxxxxxxxxx xxxx xxxxxx xxxxx xxxxxx 13 nařízení (ES) x. 1451/2007, ale xxxxx xxxxxxxxxxx Xxxxxx xxxxxx xxxxxxxxxxx xxxxxx xxxxx xx. 14 xxxx. 4 uvedeného xxxxxxxx; |
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x) |
xxxxx xxxxxxxx xxxxxxx xxxxxx x xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4 xxxx 5 xxxxxxx X xxxxxxxx (XX) č. 528/2012 podle xx. 4 xxxx. 2 x xxx xxxxxxxx poplatek xxxxx xx. 4 xxxx. 4. |
2. Xxxxxxxxx xxxxxxxxx xxxxx zhodnotí xxxxxx podle xxxxxx 4 x 5 xxxxxxxx (EU) x. 528/2012 x xxxxxxxx xxx xxxxxxx xxxxxx xx xxxxxx xxxxxxxxx xx xxxxx předložené x xxxxxxx x xx. 6 odst. 3 xxxxxxxxx xxxxxxxx x xxxxx hodnotící xxxxxx x xxxxxx xxxxx xxxxxxxxx xxxxxxxx.
3. Pokud xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxx, xxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx pouze jednu xxxxxxxxx zprávu. Xxxxxxxxx xxxxxx a závěry zašle x xxxxx x xxxxxx xxxx, xxxxx toho, xx xxxxxxx xxxxxxx:
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x) |
365 xxx po xxxxxxxxx xxxxxxxxx xxxxxxxx x xxxx. 1 xxxx. x), xxxxxx xxxxxxxx xxxxxxxx v odst. 1 xxxx. x) xxxx xxxxxxxxx xxxxxxxx xxxxxxxxx x xxxx. 1 písm. c) x dotyčné kombinace xxxxx a typu přípravku; |
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b) |
xx xxxxx xxxxxxxxx x xxxxxxx XXX. |
4. Xxxx xxx, xxx xxxxxxxxx příslušný xxxxx xxxxxxxx xxx xxxxxx xxxxxxxx, xxxxxx xxxxxxxxxxx xxxxx do 30 xxx x hodnotící xxxxxx x k xxxxxxx hodnocení xxxxxxx xxxxxxxxxx. Xxxxxxxxx xxxxxxxxx xxxxx xxxx xxxxxxxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxx x závěrečné xxxx xxxxx hodnocení.
5. Xxxxx se xxxxx, xx xxxx x xxxxxxxxx nutné xxxxxxxxxx xxxxxxxxx, xxxxxxxxx xxxxxxxxx orgán xxxxxxxxx xxxxx, aby xxxx xxxxxxxxx xx xxxxxxxxx xxxxx xxxxxxxxx, x xxxxxxxxx x tom xxxxxxxx.
Xxxxx 365 dnů xxxxxxx x odstavci 3 se přeruší xx dobu ode xxx xxxxxxxx požadavku xx xxx xxxxxxxx xxxxxxxxx. Pokud xx xxxx odůvodněno xxxxxxx xxxxxxxxxxxx xxxxx xxxx xxxxxxxxxxx xxxxxxxxxx, xxxxxxxxx xxxxxxxxxx následující xxxxx:
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a) |
365 xxx x xxxxxxx, xx xx doplňující informace xxxxxx otázek, xxxxx xxxxxx xxxxxx x xxxxx směrnice 98/8/XX xxxx x xxxxx postupů xxxxxxxxxxx pro uplatňování xxxxxxx xxxxxxxx; |
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x) |
180 dní xx xxxxx xxxxxxxxx xxxxxxxxx. |
6. Pokud xxxxxxxxx příslušný xxxxx xxxxxx, xx xxxxxxxx xxxxx xxxxxxx xxxxxx xxxx nebo zvířat xxxx xxxxxxxxx prostředí xxxxxxxxxxx x xxxxxxxxxxxxx účinků xxxxxxxxxx x xxxxxxxxx biocidních přípravků xxxxxxxxxxxx xxxxxx nebo xxxxxxxx účinné xxxxx, xxx obavy xxxxxxxxxxxx x xxxxxxx s požadavky xxxxxxxxxxx xxxxx oddílu II xxxx 3 přílohy XX nařízení Evropského xxxxxxxxxx x Rady (XX) č. 1907/2006 (8) x xxxxxx xx xx xxxxx xxxxxx.
7. X xxxxxxx xxxxxxx xx dokončení xxxxxxxxx xxxxxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx bez xxxxxxxxxx xxxxxxx a nejpozději xxx xxxxxxxxxx hodnotící xxxxxx xxxxx odstavce 3:
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x) |
xxxxxxxx xxxxx xxxxxxxx xxxxx xx. 37 odst. 1 xxxxxxxx (XX) č. 1272/2008, xxxxxxxx xx domnívá, xx xx xxxxxxx jedno x xxxxxxxx xxxxxxxxx v čl. 36 xxxx. 1 xxxxxxxxx xxxxxxxx, xxx xxxx xxxxxxxx řešeno x xxxxx 3 xxxxxxx XX xxxxxxxxx nařízení; |
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x) |
xxxxxxxxxx s agenturou, xxxxx se domnívá, xx xxxxx x xxxxxxxx xx. 5 xxxx. 1 xxxx. x) xxxx x) xxxxxxxx (XX) x. 528/2012 nebo podmínka xx. 10 odst. 1 písm. d) xxxxxxxxx nařízení xxxx xxxxxxx, xxx xxxxxx xxxxxxxx řešeny v příloze XXX nařízení (XX) x. 1907/2006 nebo x xxxxxxx xxxxxxxx x xx. 59 xxxx. 1 xxxxxxxxx xxxxxxxx. |
Xxxxxx 7
Stanovisko xxxxxxxx
1. Xxxxx xxxxxx se xxxxxxx, xxxxx platí xxxxxxx x xxxxxx podmínek:
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x) |
pokud xxxxxxxxx xxxxxxxxx orgán předložil xxxxxxxxx zprávu xxxxx xx. 6 xxxx. 2 x xxxxxxxx xxxxxxxxx xxxxx xxxx xxxxxxx xxxxxxxxxx xxxxx xx. 6 odst. 7; |
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b) |
xxxxx xxxx předložena Xxxxxx xxxxxx xxxxxxxxxxx xxxxxx xxxxx čl. 14 xxxx. 4 xxxxxxxx (XX) x. 1451/2007, xxx hodnotící zprávu xxxxx nepřezkoumal Stálý xxxxx xxx xxxxxxxx xxxxxxxxx podle čl. 15 xxxx. 4 uvedeného xxxxxxxx. |
2. Xx xxxxxxx xxxxxx xxxxxxxx xxxxxxxxx x xxxxxxxx Xxxxxx xxxxxxxxxx x xxxxxxxxx xxxxxxxxx xxxxx x xxxx přípravku xxxx xxxx xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx X xxxxxxxx (EU) x. 528/2012, xxxxxxxx xxxxxx, x xxxxxxx xx xxxxxx xxxxxxxxxxx xxxxxxxxxxx xxxxxx.
Xxxxxxxx xxxxxx xxxxxxxx xxxxxxxxxx x xxxxx x xxxxxx xxxx, podle toho, xx xxxxxxx xxxxxxx:
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x) |
xx xxx xxxxxx xx xxxxxxx xxxxxx; |
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b) |
ve lhůtě xxxxxxxxx x xxxxxxx XXX. |
Xxxxxxxx xxxxxxxx xxxxxxxxxx Komisi xx 270 xxx od zahájení xxxxxxxx.
Xxxxxx 8
Účinné xxxxx, xxxxx xx mají xxxxxxxx
1. Xxx xxxxxxxx svého xxxxxxxxxx xxxxx xx. 7 xxxx. 2 xxxxxxxx xxxxxxx, xxx xxxxxx xxxxx xxxxxxx některé x xxxxxxxx xxxxxxxxx x xx. 10 xxxx. 1 xxxxxxxx (XX) č. 528/2012, x xxxx otázku zmíní xx xxxx stanovisku.
2. Xxxx xxxx xxxxxxx xxxxxx 66 x 67 xxxxxxxx (EU) x. 528/2012, xxxxx xxx xxxxxxxx xxxxxxxx své xxxxxxxxxx Xxxxxx, zveřejní xxxxxxxxx o možných xxxxxxx, xxxxx se mají xxxxxxxx, během xxxxxxxxx 60 xxx; x xxxx xxxx xxxxx xxxxxxxxxx třetí xxxxxx xxxxxxxxx příslušné xxxxxxxxx xxxxxx informací o dostupných xxxxxxxxx. Xxxxxxxx obdržené xxxxxxxxx xxxxxxxx xxxxxxxx x xxxxxxxxx xxxx xxxxxxxx xxxxx stanoviska.
3. Pokud xx xxxxxx látka xxxxxxxxx x xxxxxxx xxxxx x xxxxxxxx stanovených x xx. 10 xxxx. 1 xxxxxxxx (EU) x. 528/2012, xxxx xxx xxxxxxxx za látku, xxxxx xx má xxxxxxxx, x xxxxxxxx xxxxxxxx x xxxxxxx s čl. 89 xxxx. 1 xxxxxx xxxxxxxxxxxx uvedeného xxxxxxxx.
Xxxxxx 9
Xxxxxxxxxx Xxxxxx
Xx xxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx xx. 7 xxxx. 2 Xxxxxx bez xxxxxxxxxx xxxxxxxx xxxxxxxx xxxxx xxxxxxxxxx pro xxxxxxx xxxxx čl. 89 odst. 1, xxxx případně podle xx. 28 xxxx. 1 xxxxxxxx (XX) x. 528/2012.
XXXXXXXX 3
XXXXX XXXXX XXXXXXXX XXXXXXXX
Xxxxxx 10
Připojení xxxx xxxxxxxxx xxxxxxxxx xx xxxxxxxx xxxxxx
1.&xxxx;&xxxx;&xxxx;Xxxx xxxxxxxxx je xxxxx xx xxxxxxxx xxxxxx xxxx xxxxxxxxxx xxxxxxxxxx x xxxxxxxxxxxx xxxxxxxxxx xxxxxxx xxxx sdílet xx předpokladu, že xx xxxxxxxxxxx xxxxxxxx xxxxx odvolávat se xx xxxxxxx údaje xxxxxxxxxx nebo xxxxxxx xxxxxxxxxx xxxxxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxxx xxx xxxxx tohoto xxxxxx xxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxxxx účastník xxxxxxxxxxxxxxx xxxxxxxxx xxx xxxxxxxx xxxxxxxxx uvedeného x článku 71 xxxxxxxx (EU) č. 528/2012 (xxxx jen „xxxxxxxx“) x&xxxx;xxxxxxxx musí xxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxx x xxxxxxxx.
3.&xxxx;&xxxx;&xxxx;Xx xxxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx 2 agentura xxxxxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxx týkající xx xxxxxxxxxx účastníka.
4. Osoba xxxxxxx xx&xxxx;xxxxx Xxxx, xxxxx xxxxxxxx roli xxxxxxxxx xxxx xx xxxxxxxxx k účastníkovi xxxxx xxxxxx xxxxxx, xx xxx xxxxx xxxxxx 95 nařízení (XX) x.&xxxx;528/2012 považována xx xxxxx, která xxxxxxxxxx xxxxxxxxxxx xxxx xxxxxxxx x xxxxxxxx x dokumentaci.
Xxxxxx 11
Odstoupení xxxxxxxxx
1. Xx xx za to, xx účastník odstoupil x xxxxxx xx xxxxxxx xxxxxxxxx látky x xxxx přípravku v programu xxxxxxxx, x xxxxxx xxxxxxxxx:
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x) |
xxxxx xxxxxxxxxx xxxxxxxx xxxx xxxxxxxxx příslušný xxxxx xxxxxxxxxxxxxxx xxxxxxxxx x svém záměru xxxxxxxxx; |
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x) |
xxxxx xxxxxxxxxxx žádost xx xxxxx xxxxxxx x xx. 3 xxxx. 2; |
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x) |
xxxxx xxxx xxxxxx byla zamítnuta xxxxx xx. 4 xxxx. 1, xx. 4 odst. 4 xxxx xx. 5 xxxx. 4; |
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x) |
pokud nepředložil xxxxxxxxxx informace xx xxxxxxx xxxxxxxxx x xx. 6 xxxx. 5; |
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x) |
xxxxx xxxxx xxxxxxxxxx xxxxxxxx hodnotícímu xxxxxxxxxxx xxxxxx nebo xxxxxxxx. |
2. Xxxxxxxxxx xx xxxxxxxx za xxxxxxxxx xxxx, xxxxx x xxxx xxxxxxx xx xxxx, xxx xxxxxxxxx příslušný xxxxx xxxxxxxxx xxxxxxxx zprávu xxxxxxxxxxx xxxxxx xxxxx xx. 6 odst. 4 xxxxxx xxxxxxxx.
Xxxxxx 12
Důsledky xxxxxxxx xxxxxxxxxx
1. Xxxxx xx x xxxxxxx xxxxxxxxxx informován xxxxxxxxx xxxxxxxxx xxxxx, xxx xxxxxx xxxxxxxx, xxxxxxxxx xx xxxxxxxxx xxxxxxxxx xxxxx bez xxxxxxxxxx odkladu prostřednictvím xxxxxxxxx.
2. Xxxxx je x xxxxxxx xxxxxxxxxx informována xxxxxxxx, xxxxxxxxxxx xxxxxxxxx x xxxxxxxxx xxxxxxxx xx xxxxxxxxxx xxxxxxxxx.
3. Xxxxx x xxxxxxxx xxxxxxxx xxxx xxxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx tutéž xxxxxxxxx xxxxx x xxxx přípravku x xxxxx xxxx role xxxxxxxxx xxx xxxxxxxx xxxxxxxxx dříve xxxxxxxx, xxxxxxxxx x tom xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx Xxxxxx.
Xxxxxx 13
Xxxx xxxxxxxx xxxxxxxxx xxxxx
1. Pokud hodnocení xxxxxxxxx xxxxxx xxxxx xxxxxxxx xxxxxxx závěry xxxxxxxx xx xxxxx, xxx xxxx xxxxxxx x xxxxxxx XX, xxxxxxxxx xxxxxxxxx xxxxx xx xxxxxxxxxx x dotyčným xxxxxxxxxx xxxxxxx xxxxx identitu xxxxx. Xxxxxxxxx xxxxxxxxx xxxxx x xxx xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx x xxxxxxxxx xxxxxxxxxxx xxxxxxxxx týkající se xxxxxxxx xxxxx.
Xxxxxx 14
Xxxxxxxx xxxx xxxxxxxxx
1. Xxxxxxxx xxxxxxxx xxxxxxxxx xxxxx k převzetí xxxx účastníka pro xxxxxxxxx xxxxx x xxxx xxxxxxxxx, xxxxx xxxxxxx xxxxx x xxxxxx xxxxxxx:
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a) |
xxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx včas xxxxxxxxxx xxxxx xxxxxx 11 x xxxxxx role xxxxxxxxx xxx xxxxx xxxxxxxxx xxxxxx xxxxxxx xxxxxxxx; |
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x) |
xx xxxxxxx xxxx definice xxxxx xxxxxx 13; v tomto případě xx xxxxx xxxx xxxxx xx xxxxx, xx xxxxxx se xxxxxxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX, xxx xxxxxxx xxxx xxxxxxxx látky. |
2. Xx xxxxxxxx xxxxxx xxx xxx zveřejnění xxxxx odstavce 1 xxxx xxxxxxxxx osoba xxxxxxxxx oznámení pro xxxxxxxxx xxxxx xxxxxx 17.
3. Xx xxxxxxxx xxxxxx xx xxxx xxxxxx xxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxx xxxxx oznámit kombinaci xxxxx x xxxx xxxxxxxxx xxxxxxxxx xx xxxxx 2 xxxxxxx XX podle xxxxxx 17.
Xxxxxx 15
Kombinace látky x xxxx xxxxxxxxx xxxxxxxxx pro zařazení xx xxxxxxxx xxxxxxxx
Xxxxx xxxxxxxx xxxxxxxxx, xxxxx xxxxx xx oblasti xxxxxxxxxx xxxxxxxx (XX) x. 528/2012 x je xxxxxx na trh, xxxxxxx xx stávající xxxxxx xxxxx, xxx xxxx xxxxxxxxx ani xxxxxxxx do programu xxxxxxxx xxx tento xxx přípravku a xxxx xxxxxxxx do xxxxxxx I xxxxxxxxx xxxxxxxx, tuto xxxxx xxxxxxxx nebo xx x ní vyrábí, xx uvedená xxxxx xxxxxxxxx xxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxx xxxxxxxxx xxx přípravku xx xxxxxxx xxxxxxxxx x xxxxxx xxxxxx:
|
x) |
xxxxx uvádějící výrobek xx xxx se xxxxxxxxx xx xxxxxx xxxx xxxxxxx xxxxxxxxxx xxxxxx Xxxxxx xxxx příslušným xxxxxxx jmenovaným x xxxxxxx x xxxxxxx 26 směrnice 98/8/XX nebo článkem 81 xxxxxxxx (XX) x. 528/2012, xxxxx xx xxxxxxx xxxxxxxxxx opodstatněných xxxxxx xxxxx xxxxxxx xxxxxx xx xxxxxxxxxx k xxxxxxxxxxx, xx xxxxxxx byl xxxxx x xxxxxxxxxx směrnice 98/8/XX xxxx xxxxxxxx (XX) x. 528/2012, xxxx xx byl xxxxxxxxx xxx xxxxxxxxx jedním x xxxxxxxxx, xxx xxxxx xxxx xxxxxx xxxxx xxxxxxxx, x xxxxx xxxx uvedené xxxxxx či doporučení xxxxxxxx přezkoumány x xxxxxxxxxx přijatém xxxxx xx. 3 xxxx. 3 xxxxxxxx (XX) č. 528/2012 xxxx x xxxxxx, xxxxxxxxx xxxxxxxx xxxxxxxxxxxx Komisí; |
|
x) |
xxxxx xxxxxxxxx xxxxxxxx pro xxxxxxxxx x xxxxxx xxxxxxxxx x xxxxxx 6 xxxxxxxx (XX) č. 1451/2007; |
|
x) |
xxxxxxxx přípravek xxxxx xxxxx xxxxxxxx (XX) č. 528/2012 k xxxxxxxxx xxxx xxxxxxxxx, xxx xxxx bylo xxxxx xxxxxxxx 98/8/XX, x xxxxxxxx xxxxx xxxxxxxxxx xxxxxx xxxx xxxxxxxxx x xxxxxxxx xxxxx xxxxxxxxx xx xxxxxxxx xxxxxxxx pro xxxxxxx xxx xxxxxxxxx, xxx xxxxxx pro xxxx. |
Xxxxxx 16
Xxxxxxxxxx x xxxxx na xxxxxxxx
1. Xxxxxxxxxx x xxxxx oznámit xxxxx, xxxxx xx xxxxxxxxx xxx xxxxxxxx xx xxxxxxxx xxxxxxxx podle xxxxxx 15, předkládá prostřednictvím xxxxxxxxx kterákoli osoba, xxx xx xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx přípravku, xxxxxxx x xxxxxxxxxxxxx příjemců:
|
x) |
Komisi xxxxxxxxxx xxxxxxx xxxxxx xx xxxxxxxxxx xxxxxxxxxx xxxx xxxxxx uvedených x xx. 15 písm. a); |
|
b) |
agentuře nejpozději 30. října 2015 x xxxxxxxxx xxxxxxxxx x xx. 15 xxxx. x); |
|
x) |
Komisi xxxxxxxxxx 30. xxxxx 2015 v případech xxxxxxxxx x xx. 15 xxxx. x). |
2. Xxxxxxxxxx xxxx xxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx. V případech xxxxxxxxx x xx. 15 xxxx. x) musí xxxxxxxxxx xxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx, x nějž vyplývá, xx jsou splněny xxxxxxx xxxxxxxx v xxx xxxxxxx.
3. Xxxxx xxxx xxxxxxxxxx učiněno v případě xxxxxxxx x xx. 15 xxxx. x) nebo c) x Xxxxxx xxxxxxx xx xxxxxxxxxx x xxxxxxxxx státy x závěru, xx xxxxxxxx 6 xxxx xxxxxxxxxx, x xxxxxxxx, xx xxxx xxxxxxx podmínky xxx xxxxxxxx uvedené x xx. 15 písm. a), xxxxxxx x xxx xxxxxxxx.
4. Xxxxx xxxx xxxxxxxxxx xxxxxxx x xxxxxxx uvedeném x xx. 15 písm. x) xxxx xxxxx Xxxxxx xxxxxxxxxxx xxxxxxxx podle xxxxxxxx 3, xxxxxxxx xxxxxxxx xxxx xxxxxxxxx elektronickými xxxxxxxxxx x xxxxxxxx příslušné xxxxxxxxx xxxxx a typu xxxxxxxxx. Pro účely xxxxxx xxxxxxxx xx xxxxxxxxxx podle xx. 3x xxxx. 3 xxxxxxx pododstavce xxxxxxxx (XX) č. 1451/2007 xxxxxxxx xx xxxxxxxxxx xxxxx xxxxxx odstavce.
5. Xxxxxxxxx xxxxx, která xx xxxxx xxxxxxx kombinaci xxxxx x typu xxxxxxxxx, xxx může xxxxxx xxxxx článku 17 xx xxxxx xxxxxx xxx dne xxxxxxxxxx xxxxx odstavce 4.
6. X xxxxxxxxx xxxxxxxxx x xx. 15 xxxx. x) x x) xx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxx xx xxxxxxxxx účastníkem x xxxx xxxxxxxxx x dalšímu xxxxxxxx, xxxxx xxxx xxxxxxx tyto podmínky:
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a) |
xxxxxxxxx xxxxxx látka xx xxx xxxxxxxx do programu xxxxxxxx; |
|
x) |
xxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx státu xxx xxxxxxxxxx xxxxxxx látku xxx xxxxxxxx xxxxxxx xxxxx, xxxxx xxxx xxxxxxxx xxx hodnocení xxxx xxxxxxxxx; |
|
x) |
účastník, který xxxxxxxxx xxxxxxxx dokumentaci, xxxxx, xx má xxxxx o podporu xxxx xxxxxxxxx látky x xxxx přípravku. |
Xxxxxx 17
Postup oznámení
1. Oznámení xxxxx xx. 14 xxxx. 2 x 3 xxxx xx. 16 xxxx. 5 se xxxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxxxxx musí být xxxxxxxxxx xx formátu XXXXXX. Musí obsahovat xxxxx xxxxxxx v xxxxxxx X.
3. Xxxxx není x xxxxxxx XX xxx xxxxxxxx xxxxxxx xxxxx xxxxxx xxxxxxxxx xxxxxxxxx xxxxx, xxxxxxxxx xxxxxxxxxxx xxxxxxxx x xxxxx xxx xxxxxxxxx xxxxxxxxxxx xxxxxx, který xx xxxxxxxx v souladu x xxxxxxx 81 nařízení (XX) x. 528/2012, x xxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx, že příslušný xxxxx xxxxxxxx x xxx, xx xxxxxxxxxxx xxxxxxx.
4. Xx xxxxxxxx xxxxxxxx x tom xxxxxxx xxxxxxxx Komisi a xxxxxxxxxxxx informuje x xxxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx (XX) x. 564/2013. Xxxxxxxx xxxxxxxxxxx xxxxxxxx xxxxxxxx xx 30 xxx xx xxxxxxx uvedené xxxxxxxxx, xxxxxxxx xxxxxxxx xxxxxxx x uvědomí x xxx xxxxxxxxxxxx x Komisi.
5. Po xxxxxxxx xxxxxxxx agentura xx 30 xxx xxxxx, xxx oznámení vyhovuje xxxxxxxxxx xxxxxxxx v xxxxxxxx 2. Pokud xxxxxxxx těmto xxxxxxxxxx xxxxxxxxxx, xxxxxxxx xxxxxxxx xxxxxxxxxxxx lhůtu v xxxxx 30 xxx, xxx xxx xxxxxxxx xxxxxxx xxxx xxxxxxx. Xx xxxxxxxx xxxx 30xxxxx xxxxx xxxxxxxx xx 30 xxx xxx prohlásí, že xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxx 2, nebo xxxxxxxx xxxxxxx, x xxx rozhodnutí xxxxx xxxxxxxxxxxx x Xxxxxx.
6. V xxxxxxx x článkem 77 xxxxxxxx (XX) x. 528/2012 xxxxx xxxxxxxxxxx xxxxxxxx podle xxxxxxxx 4 xxxx 5 xxxxx opravný xxxxxxxxxx.
7. Xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx podle xxxxxxxx 5:
|
x) |
x xxxxxxx, xx xxxx xxxxxxxx xxxxxxxxxx podle xx. 14 xxxx. 2 xxxx 3, xxxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx x xxxxxxxxx xxxxxxxx xx xxxxxxxxxx xxxxxxxxx x xxxxxxxx xxxxxxxx xxxxx; |
|
x) |
x xxxxxxx, že oznámení xxxx xxxxxxxxxx xxxxx xx. 16 xxxx. 5, xxxxxxxx xxxxxxxxxx xxxxxxxxx Xxxxxx, že xxxxxxxxxx bylo xxxxxxxx. |
Xxxxxx 18
Xxxxxxxx do xxxxxxxx xxxxxxxx
Xxxxx xx xxxxxxxxx xxxxx x xxxx xxxxxxxxx považována xx xxxxxxxxx x xxxxxxx x xx. 16 xxxx. 6 xxxx pokud xxxxxxxx xxxxxxxxx Xxxxxx x dodržení xxxxxxxxx x xxxxxxx x xx. 17 xxxx. 7 xxxx. x), xxxxxx Xxxxxx xxxxxxxxx xxxxx x xxxx přípravku do xxxxxxxx přezkumu.
Xxxxxx 19
Informace x xxxxxxx, xxxxx xxxxxx xxxxxx xxxxxxxxxxx x xxxxx xxxxxxxx xxxxxxxx
Xxxxx xxxxxx ve lhůtě xxxxxxxxx x xx. 16 xxxx. 5 xxxxxxxx xxxxx xxxxxxxx xxxx xxxxx xxxx oznámení xxxxxxx xx zmíněném xxxxxx xxxxxxx x xxxxxxxx xxxxxxxxx agenturou xxxxx xx. 17 odst. 4 xxxx 5, xxxxxxxx o tom xxxxxxxxx xxxxxxx státy xxxxxxxxxxxxxxx rejstříku a zveřejní xxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx.
Xxxxxx 20
Xxxxxxxxxx Komise x látkách, xxxxx xxxxxx xxxxxx podporovány x xxxxx xxxxxxxx xxxxxxxx
Xxxxxx připraví xxxxx xxxxxxxxxx x neschválení xxxxx xx. 89 xxxx. 1 xxxxxxx xxxxxxxxxxx nařízení (XX) x. 528/2012 x xxxxxx xxxxxxxxx:
|
x) |
xxxxx xxxxxxxx informuje Xxxxxx x xxxxxxx xxxxxxxxxx xxxxxxxxx podle xx. 12 xxxx. 3 xxxxxx xxxxxxxx; |
|
b) |
pokud xxxxx xxxxx xxxxxxxx xxxxxxxx ve lhůtách xxxxxxxxxxx x xx. 14 xxxx. 2 xxxx 3 xxxxxx xxxxxxxx xxxx pokud bylo xxxxxxxx xxxxxxxxxx a zamítnuto xxxxx čl. 17 odst. 4 xxxx 5; |
|
x) |
xxxxx xxxx xxxxxxxx předloženo xx xxxxx xxxxxxxxx v čl. 14 odst. 2 xxxx 3 xxxxxx xxxxxxxx x xxxx xxxxxxxx xxxxxxxxx xxxxx xx. 17 xxxx. 5 xxxxxx xxxxxxxx, xxx xxxxxxxx xxxxx x xxxxxxxx xxxxxxxx xxxxx xxxx xxxxxxxxx identity x xxxxxxx XX xxxxxx xxxxxxxx. |
V případě xxxxxxxx v prvním pododstavci xxxx. c) xx xxxxx rozhodnutí x xxxxxxxxxxx xxxxxxxx na xxxxxx xxxxx, na kterou xx xxxxxxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX xxxxxx xxxxxxxx, xxxxx xxxxxx xxxxxxxx nebo xxxxxxxx xxxxxxxxxx x xxxxxxxxx.
XXXXXXXX 4
PŘECHODNÁ XXXXXXXX
Xxxxxx 21
Xxxxxxxxx opatření xxx xxxxx xxxxxxx v článku 15
1. Členský xxxx xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx svého xxxxxxxxxxx xxxxxxx xxxx praxe xxxxxxxx na trh x&xxxx;xxxxxxxxx xxxxxxxxxx xxxxxxxxx, který xxxxxxx xx xxxxxxxxx xxxxxx xxxxx xxxxxxx x xx. 15 xxxx. b) x x), xxxx látku xxxxxxxx xxxx x xx vzniká. V xxxxxx xxxxxxxxx:
|
x) |
xxxxx xxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;24 xxxxxx xx xxxx xxxxxx tohoto xxxxxxxx x&xxxx;xxxxxxxx; |
|
x) |
xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxx xxxx využívány xx&xxxx;30 měsíců xx xxx vstupu xxxxxx xxxxxxxx x&xxxx;xxxxxxxx. |
2.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx xxxxx stávajícího xxxxxxx xxxx praxe dodávání xx&xxxx;xxx x&xxxx;xxxxxxxxx biocidního xxxxxxxxx, který xxxxxxx xx xxxxxxxxx xxxxxx xxxxx xxxxxxx x xx. 15 xxxx. x), tuto xxxxx xxxxxxxx xxxx x xx vzniká. V xxxxxx případech:
|
a) |
nesmí být xxxxxxxx xxxxxxxxx nadále xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;24 xxxxxx xx xx x xxxx xxxxxxxxx událostí, která xxxxxxx xxxxxxx:
|
|
x) |
xxxxxxxxx xxxxxx biocidního přípravku xxxxx xxx xxxx xxxxxxxxx do 30 xxxxxx xx xx z xxxx uvedených xxxxxxxx, xxxxx xxxxxxx xxxxxxx:
|
3.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx může xxxxxxxxxx v uplatňování svého xxxxxxxxxxx xxxxxxx nebo xxxxx dodávání na trh x&xxxx;xxxxxxxxx biocidního přípravku, xxxxx sestává ze xxxxxxxxx xxxxxx látky xxxxxxxxxx xxxxxxxxx xxxxx xx. 16 odst. 4 xxx xxxxxxxxx xxx výrobku, tuto xxxxx xxxxxxxx xxxx x ní vzniká. X xxxxxx xxxxxxxxx:
|
x) |
xxxxx xxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx od dvanácti xxxxxx xx xxxx, kdy xxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxx článku 19 x |
|
x) |
xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxx xxxx xxxxxxxxx xx&xxxx;xxxxxxxx xxxxxx po xxxx uvedeného xxxxxxxxxx. |
Xxxxxx 22
Nezbytná xxxxxxx
1. Xxxx xx xxxxxx čl. 55 xxxx. 1 nařízení (XX) x. 528/2012, xx xxxxxxxx xxxxxx xx xxxx xxxxxxxxxx x xxxxxxxxxxx xxxxxxxxx účinné látky, xxxxx členský xxxx xxxxxxxx xxxx xxxxxxxxx xxxxxxx látku xx xxxxxxxxx z důvodů uvedených x xx. 5 xxxx. 2 xxxxxx pododstavci xxxx. x) xxxx x) nařízení (XX) x. 528/2012, xxxxx členský xxxx může předložit Xxxxxx xxxxxxxxxxx žádost x xxxxxxxx xx xx. 89 odst. 2 xxxxxxx pododstavce xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx xxxxxxx xxxx xxxxxxxx xxxxxxxxxxx žádost xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx. Xxxxx žádost xxxxxxxx xxxxxxx xxxxxxxxx, xxxxxxxx xxxxxxx xxxx xxxx xxxxxxx xxxxxxxxx xxxxxxxxx xxxxx.
3. Xxxxxxxx xxxxxxxx xxxxxx xxxx xxxxxxxx xxxxxxxxxx xxxxx elektronickými prostředky. Xxxxxxx státy nebo xxxx osoby xxxxx xxxxx xxxxxxxxxx xx xxxxx 60 xxx po xxxxxxxxxx.
4. Xx zvážení xxxxxxxxxx xxxxxxxxxx xxxx Komise xxxxxxx xxxxxxxx od čl. 89 xxxx. 2 druhého xxxxxxxxxxx xxxxxxxx (EU) č. 528/2012, xxxxx umožní uvádět xxxxxxxx xxxxxxxxx, jež xxxxxxxxx x xxxx xxxxx, xxxxxxxx ji xxxx z xx xxxxxxxx, na xxx xxxxxxxxxx xxxxxxxxx xxxxx x xxxxxxxx xx v daném xxxxxxxx xxxxx v souladu x xxxxxxxxxxxxxx xxxxxxxx předpisy x x xxxxxxxx xxxxxxxx xxxxxxxx 5 a veškerých dalších xxxxxxxx uložených Xxxxxx.
5. Členský xxxx, jemuž je xxxxxxxx xxxxxxxx:
|
a) |
xxxxxxx, xx xxxxx xxxxxxxxx xxxx xxxxxxx xx xxxxxx xxxxxxx a xxxxxxx dobu, xxx xxxx plněny xxxxxxxx xxxxxxxx 1; |
|
x) |
xxxxxx xxxxxx opatření xx xxxxxxxx xxxxx, aby xxxxxxxx minimalizaci xxxxxxxx xxxxxxx, zvířat nebo xxxxxxxxx xxxxxxxxx; |
|
x) |
xxxxxxx, aby xx hledala alternativní xxxxxx xxxx aby xxxx xxxx xxxx xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxx x xxxxxxxxx xxxxxx xxxxx x xxxxxxx xxxxxxx 7 xxxxxxxx (XX) č. 528/2012. |
XXXXXXXX 5
ZÁVĚREČNÁ XXXXXXXXXX
Xxxxxx 23
Xxxxxxx
Xxxxxxx xx nařízení (XX) x. 1451/2007.
Odkazy xx xxxxxxx nařízení xx xxxxxxxx za xxxxxx na toto xxxxxxxx.
Xxxxxx 24
Vstup x xxxxxxxx
Xxxx nařízení xxxxxxxx x xxxxxxxx xxxxxxxx xxxx xx xxxxxxxxx x Xxxxxxx xxxxxxxx Xxxxxxxx xxxx.
Xxxx xxxxxxxx xx xxxxxxx x xxxxx xxxxxxx x xxxxx xxxxxxxxxx xx všech xxxxxxxxx státech.
V Xxxxxxx xxx 4. xxxxx 2014.
Xx Komisi
předseda
José Manuel XXXXXXX
(1) Úř. xxxx. L 167, 27.6.2012, s. 1.
(2)&xxxx;&xxxx;Xxxxxxxx Xxxxxx (XX) x. 1451/2007 xx xxx 4. prosince 2007 o druhé xxxxx desetiletého pracovního xxxxxxxx xxxxxxxxx x xx. 16 xxxx. 2 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx 98/8/XX x xxxxxxx xxxxxxxxxx přípravků xx xxx (Xx. xxxx. X 325, 11.12.2007, x. 3).
(3) Směrnice Evropského parlamentu x Rady 98/8/XX xx xxx 16. xxxxx 1998 x xxxxxxx biocidních přípravků xx xxx (Úř. xxxx. X 123, 24.4.1998, s. 1).
(4) Rozsudek Soudního dvora (xxxxxxx senátu) xx xxx 1. března 2012 (žádost o xxxxxxxxxx o předběžné xxxxxx: Xxxxxxxxxxx Xxxxxxx – Německo) – Xöxx XxxX proti Xxxxx XxxX (xxxxxxx xxxxxxxxxx xxxxxxxxx na xxx – směrnice 98/8/XX – čl. 2 xxxx. 1 xxxx. x) – xxxxx „biocidní přípravky“ – xxxxxxxxx, xxxxx xxxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx, aniž je xxxx, xxxxxxxx nebo xxxxxxxxxxx), C-420/10.
(5)&xxxx;&xxxx;Xxxxxxxxx nařízení Xxxxxx (XX) č. 88/2014 xx xxx 31.&xxxx;xxxxx 2014, xxxxxx xx stanoví xxxxxx pro xxxxx xxxxxxx I nařízení Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (EU) x.&xxxx;528/2012 o dodávání biocidních xxxxxxxxx xx xxx x&xxxx;xxxxxx xxxxxxxxx (Xx. xxxx. X 32, 1.2.2014, x. 3).
(6)&xxxx;&xxxx;Xxxxxxxx Evropského xxxxxxxxxx x Rady (ES) x. 1272/2008 ze xxx 16. prosince 2008 x xxxxxxxxxxx, xxxxxxxxxx x balení xxxxx x xxxxx, x xxxxx a xxxxxxx směrnic 67/548/XXX x 1999/45/XX x x změně xxxxxxxx (XX) x. 1907/2006 (Xx. xxxx. 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 xxx xxxxxxxx xxxxx xxxxx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) č. 528/2012 x&xxxx;xxxxxxxx biocidních xxxxxxxxx xx xxx a jejich xxxxxxxxx (Xx.&xxxx;xxxx.&xxxx;X 167, 19.6.2013, s. 17).
(8)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Rady (ES) x. 1907/2006 xx xxx 18. prosince 2006 x xxxxxxxxxx, xxxxxxxxx, xxxxxxxxxx x xxxxxxxxx xxxxxxxxxx xxxxx, x zřízení Xxxxxxxx xxxxxxxx pro xxxxxxxx xxxxx, x změně xxxxxxxx 1999/45/XX x x xxxxxxx nařízení Xxxx (XXX) x.&xxxx;793/93, xxxxxxxx Komise (XX) x. 1488/94, xxxxxxxx Xxxx 76/769/XXX x xxxxxxx Xxxxxx 91/155/XXX, 93/67/XXX, 93/105/ES a 2000/21/XX (Úř. věst. X 396, 30.12.2006, x. 1).
XXXXXXX X
Xxxxxxxxx xxxxxxxxxx xxx xxxxxxxx xxxxx xxxxxx 17
Xxxxxxxx xxxxx xxxxxx 17 xxxxxxxx xxxx informace:
|
1) |
xxxxx, že látka xx stávající xxxxxxx xxxxxx xx xxxxxx xx. 3 xxxx. 1 písm. d) nařízení (XX) x. 528/2012; |
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2) |
xxxxx x xxxx/xxxxxx xxxxxxxxx, xx xxxxx/x xx oznámení xxxxxxxx; |
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3) |
xxxxxxxxx o všech studiích, xxxxx xxxx xxxxxx xxx xxxxx xxxxxxx x xxxxxxxxx či zařazení xx xxxxxxx X xxxxxxxx (XX) x. 528/2012, jakož x xxxxxxxxx xxxxx xxxxxx dokončení; |
|
4) |
xxxxxxxxx xxxxxxx x xxxxxxxx
|
|
5) |
xxxxx xxxx xxxx xxxxxxxx xxxxxxx x xxxxxxx uvedeném x xx. 15 xxxx. a), xxxxx, xx xxxxx byla xx xxxx xxxx účinná xxxxx biocidního přípravku xxxxxxxxxxx do příslušného xxxx xxxxxxxxx x xxx xxxxxxxx xxxx xxxxxxxxxx rozhodnutí xxxx xxxxxx xxxxxxxxx xx xxxxxxxx xxxxxxx. |
XXXXXXX II
XXXXXXXXX LÁTKY X XXXX PŘÍPRAVKU ZAŘAZENÉ XX XXXXXXXX XXXXXXXX XXX 4. XXXXX 2014
ČÁST 1
Xxxxxxxxx účinné xxxxx x xxxx xxxxxxxxx podporované xx xxx 4. xxxxx 2014, s výjimkou xxxxxxxxxx jiných xxxxxxxxxxxxx xxx xxxx, které xxxx xxxxxxxx xxxxxxx x xxxxxxxxx 1017 x 1019.
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Xxxxxxx stát xxxxxxxxx |
Xxxxx ES |
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8 |
9 |
10 |
11 |
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13 |
17 |
18 |
19 |
21 |
22 |
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1 |
formaldehyd |
XX |
200-001-8 |
50-00-0 |
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x |
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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 |
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200-143-0 |
52-51-7 |
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29 |
xxxxxxxxxxx |
XX |
200-431-6 |
59-50-7 |
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36 |
xxxxxxx |
XX |
200-578-6 |
64-17-5 |
x |
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37 |
xxxxxxxx mravenčí |
XX |
200-579-1 |
64-18-6 |
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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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43 |
xxxxxxxx xxxxxxxxxx |
NL |
200-712-3 |
69-72-7 |
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x |
x |
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45 |
propan-1-ol |
DE |
200-746-9 |
71-23-8 |
x |
x |
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52 |
ethylenoxid |
X |
200-849-9 |
75-21-8 |
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60 |
kyselina xxxxxxxxx |
XX |
201-069-1 |
77-92-9 |
x |
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69 |
xxxxxxxxx xxxxxxxx/2-xxxxxxxxxxxxxxx xxxxxxxx |
LT |
201-180-5 |
79-14-1 |
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70 |
kyselina xxxxxxxxxxxx |
XX |
201-186-8 |
79-21-0 |
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71 |
X-(+)-xxxxxx kyselina |
XX |
201-196-2 |
79-33-4 |
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79 |
2-xxxxxxxxxxx-8,9-xxxxxxxxx-1,2,6,6x,12,12x-xxxxxxxxxxxxxxxxx[3,4-x]xxxx[2,3-x]xxxxxxx-6-xx (xxxxxxx) |
UK |
201-501-9 |
83-79-4 |
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85 |
xxxxxxxxx |
XX |
201-782-8 |
87-90-1 |
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92 |
bifenyl-2-ol |
XX |
201-993-5 |
90-43-7 |
x |
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113 |
cinnamaldehyd/3-fenylprop-2-enal (xxxxxxxxxxxxx) |
XX |
203-213-9 |
104-55-2 |
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117 |
xxxxxxxx |
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203-377-1 |
106-24-1 |
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122 |
xxxxxxx |
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203-474-9 |
107-22-2 |
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133 |
xxxx-2,4-xxxxxxx xxxxxxxx (kyselina xxxxxxx) |
XX |
203-768-7 |
110-44-1 |
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136 |
xxxxxxxx (xxxxxxxxxxxxx) |
XX |
203-856-5 |
111-30-8 |
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154 |
chlorofen |
N |
204-385-8 |
120-32-1 |
|
x |
x |
|
|
|
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|
|
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|
|
171 |
2-xxxxxxxxxxx-1-xx |
XX |
204-589-7 |
122-99-6 |
x |
x |
|
x |
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
|
172 |
xxxxxxxxxxxxxxx-xxxxxxx/1-xxxxxxxxxxxxxxxx-1-xxx-xxxxxxx |
UK |
204-593-9 |
123-03-5 |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
tosylchloramid, xxxxx xxx (xxxxx sůl xxxxxxxxxxxxxxx – xxxxxxxxx X) – (X-xxxxx-4-xxxxxxxxxxxx-1-xxxxxxxxxx |
ES |
204-854-7 |
127-65-1 |
|
x |
x |
x |
x |
|
|
|
|
|
|
|
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|
187 |
xxxxxx-xxxxxxxxxxxxxxxxxxxxxx |
XX |
204-875-1 |
128-03-0 |
|
|
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|
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|
x |
|
x |
x |
|
|
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|
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|
188 |
xxxxxxx-xxxxxxxxxxxxxxxxxxxxxx |
UK |
204-876-7 |
128-04-1 |
|
|
|
|
|
|
|
|
x |
|
x |
x |
|
|
|
|
|
|
|
195 |
xxxxxxx-xxxxxxx-2-xxxx |
ES |
205-055-6 |
132-27-4 |
x |
x |
x |
x |
|
x |
x |
|
x |
x |
|
|
x |
|
|
|
|
|
|
198 |
X-[(xxxxxxxxxxxxxx)xxxxxxxx]xxxxxxxx (xxxxxx) |
XX |
205-088-6 |
133-07-3 |
|
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x |
|
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 |
|
|
|
|
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
227 |
2-(xxxxxxx-4-xx)xxxxxxxxxxxx (thiabendazol) |
XX |
205-725-8 |
148-79-8 |
|
|
|
|
|
|
x |
|
x |
x |
|
|
|
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|
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|
235 |
xxxxxx |
XX |
206-354-4 |
330-54-1 |
|
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|
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|
x |
|
|
x |
|
|
|
|
|
|
|
|
|
239 |
karbamonitril |
XX |
206-992-3 |
420-04-2 |
|
|
x |
|
|
|
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|
x |
|
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|
253 |
xxxxxxxxxx-3,5-xxxxxxxx-1,3,5-xxxxxxxxxx-2-xxxxx (dazomet) |
XX |
208-576-7 |
533-74-4 |
|
|
|
|
|
x |
|
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|
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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 |
|
|
|
|
|
|
x |
|
|
|
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|
|
|
|
|
x |
|
|
283 |
xxxxxxxxx |
XX |
212-950-5 |
886-50-0 |
|
|
|
|
|
|
x |
|
x |
x |
|
|
|
|
|
|
|
|
|
288 |
X-[(xxxxxxxxxxxxxxxxxx)xxxxxxxx]-X-xxxxx-X′,X′-xxxxxxxxxxxxxxxx (xxxxxxxxxxxxx) |
UK |
214-118-7 |
1085-98-9 |
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
x |
|
|
289 |
xxxxxxxxxxxx xxxxx |
XX |
214-183-1 |
1111-67-7 |
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
x |
|
|
292 |
[(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl]-trans-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyklopropan-1-karboxylát (x-xxxxx-xxxxxxxxxxxx) |
XX |
214-619-0 |
1166-46-7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
958 |
xxxxxxxx xxxxxxxx/xxxxxxxxxxx vápno/hašené xxxxx |
XX |
215-137-3 |
1305-62-0 |
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
959 |
xxxx vápenatý/vápno/pálené xxxxx/xxxxxxxx xxxxx |
XX |
215-138-9 |
1305-78-8 |
|
x |
x |
|
|
|
|
|
|
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|
|
|
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|
|
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|
306 |
xxxx měďný |
XX |
215-270-7 |
1317-39-1 |
|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
x |
|
|
315 |
butan-2-on-peroxid |
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 |
X-(3-xxxxxxxxxxx)-X-xxxxxxxxxxxxx-1,3-xxxxxx (xxxxxx) |
XX |
219-145-8 |
2372-82-9 |
|
x |
x |
x |
|
x |
|
x |
|
|
x |
x |
x |
|
|
|
|
|
|
336 |
N,N′-dimethyl-2,2′-disulfandiyldibenzamid (XXXXX) |
XX |
219-768-5 |
2527-58-4 |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
339 |
1,2-xxxxxxxxxxxxxxx-3(2X)-xx (XXX) |
ES |
220-120-9 |
2634-33-5 |
|
x |
|
|
|
x |
|
|
x |
|
x |
x |
x |
|
|
|
|
|
|
341 |
2-xxxxxxxxxxxxxxxxxxxxxxxxxx-3(2X)-xx (MIT) |
SI |
220-239-6 |
2682-20-4 |
|
|
|
|
|
x |
|
|
|
|
x |
x |
x |
|
|
|
|
|
|
346 |
xxxxxxx-xxxxxxxxxxxxxxxxxx xxxxxxxx |
XX |
220-767-7 |
51580-86-0 |
|
x |
x |
x |
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
|
345 |
xxxxxxx-xxxxxxxxxxxxxxxxxx |
XX |
220-767-7 |
2893-78-9 |
|
x |
x |
x |
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
|
348 |
xxxxx(xxxxxxxxx)xxxxxxxxxxxxxxx-xxxxx-xxxxxx (MES) |
XX |
221-106-5 |
3006-10-8 |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
354 |
xxxxxxxxx |
XX |
222-182-2 |
3380-34-5 |
x |
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
359 |
(xxxxxxxxxxxx)xxxxxxxxxx (xxxxxxx xxxxxxxx xxxxxxxxxxxxxx a xxxxxxxxxxxxxxxx (XXXxxx)) |
PL |
222-720-6 |
3586-55-8 |
|
x |
|
|
|
x |
|
|
|
|
x |
x |
x |
|
|
|
|
|
|
365 |
pyridin-2-thiol-1-oxid, xxxxx xxx (xxxxxxxxx sodný) |
XX |
223-296-5 |
3811-73-2 |
|
x |
x |
|
|
x |
x |
|
x |
x |
|
|
x |
|
|
|
|
|
|
368 |
1-(3-xxxxxxxxxx)-3,5,7-xxxxxx-1-xxxxxxxxxxxxxxx-xxxxxxx (XXXX) |
XX |
223-805-0 |
4080-31-3 |
|
|
|
|
|
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
377 |
1,3,5-xxxx(2-xxxxxxxxxxxx)xxxxxxxxx-1,3,5-xxxxxxx (XXX) |
PL |
225-208-0 |
4719-04-4 |
|
|
|
|
|
x |
|
|
|
|
x |
x |
x |
|
|
|
|
|
|
382 |
1,3,4,6-xxxxxxxx(xxxxxxxxxxxxx)xxxxxxxxxxxxxxxx[4,5-x]xxxxxxxx-2,5-xxxx (XXXX) |
XX |
226-408-0 |
5395-50-6 |
|
x |
|
|
|
x |
|
|
|
|
x |
x |
x |
|
|
|
|
|
|
387 |
xxxxxxxxxxxxxxxxx (XXX) |
XX |
227-062-3 |
5625-90-1 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
|
392 |
xxxxxxxx-xxxxxxxxxxxx |
XX |
228-652-3 |
6317-18-6 |
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
393 |
1,3-xxx(xxxxxxxxxxxxx)-5,5-xxxxxxxxxxxxxxxxxxxx-2,4-xxxx (XXXXX) |
XX |
229-222-8 |
6440-58-0 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
|
397 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxxx (XXXX) |
XX |
230-525-2 |
7173-51-5 |
x |
x |
x |
x |
|
x |
|
x |
|
x |
x |
x |
|
|
|
|
|
|
|
401 |
xxxxxxx |
SE |
231-131-3 |
7440-22-4 |
|
x |
|
x |
x |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
403 |
měď |
XX |
231-159-6 |
7440-50-8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
405 |
oxid xxxxxxxx |
XX |
231-195-2 |
7446-09-5 |
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
424 |
xxxxxx sodný |
NL |
231-599-9 |
7647-15-6 |
|
x |
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
|
432 |
xxxxxxxx xxxxx |
XX |
231-668-3 |
7681-52-9 |
x |
x |
x |
x |
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
|
434 |
xxxxxxxxxxxx |
XX |
231-711-6 |
7696-12-0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
439 |
xxxxxxx xxxxxx |
XX |
231-765-0 |
7722-84-1 |
x |
x |
x |
x |
x |
x |
|
|
|
|
x |
x |
|
|
|
|
|
|
|
444 |
7x-xxxxxxxxxxxx-1X,3X,5X-xxxxxxx[3,4-x]xxxxxx (XXXX) |
XX |
231-810-4 |
7747-35-5 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
|
450 |
xxxxxxxx xxxxxxxx |
XX |
231-853-9 |
7761-88-8 |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
453 |
peroxodisíran xxxxx |
XX |
231-892-1 |
7775-27-1 |
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
455 |
xxxxxxxx xxxxxxxx |
XX |
231-908-7 |
7778-54-3 |
|
x |
x |
x |
x |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
457 |
xxxxx |
XX |
231-959-5 |
7782-50-5 |
|
x |
|
|
x |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
458 |
xxxxx amonný |
UK |
231-984-1 |
7783-20-2 |
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
|
473 |
xxxxxxxxxx x xxxxxxxxxxx |
XX |
232-319-8 |
8003-34-7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
|
491 |
xxxx xxxxxxxxxx |
XX |
233-162-8 |
10049-04-4 |
|
x |
x |
x |
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
x |
|
x |
x |
|
|
|
|
|
|
|
|
|
515 |
xxxxxx xxxxxx |
XX |
235-183-8 |
12124-97-9 |
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
|
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 |
|
|
|
|
|
x |
|
|
|
|
x |
|
|
|
|
|
|
|
|
526 |
xxxxxx-xxxxxxx-2-xxxx |
ES |
237-243-9 |
13707-65-8 |
|
|
|
|
|
x |
|
|
x |
x |
|
|
x |
|
|
|
|
|
|
529 |
xxxxxxxxxxxxxxx |
NL |
237-601-4 |
13863-41-7 |
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
531 |
(benzyloxy)methanol |
XX |
238-588-8 |
14548-60-8 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
|
534 |
xxx(1-xxxxxxxxxxxxxx-2(1X)-xxxxxxxx-X,X)xxxxxxx xxxxxxx (xxxxxxxxx xxxx) |
XX |
238-984-0 |
14915-37-8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
541 |
natrium-4-chlor-3-methylfenolát |
XX |
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) |
XX |
242-354-0 |
18472-51-0 |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
554 |
4-[(dijodmethyl)sulfonyl]-1-methylbenzen |
XX |
243-468-3 |
20018-09-1 |
|
|
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|
|
|
559 |
[(benzothiazol-2-yl)sulfanyl]methyl-thiokyanát (XXXXX) |
X |
244-445-0 |
21564-17-0 |
|
|
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
|
|
|
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) |
XX |
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) |
XX |
246-764-0 |
25254-50-6 |
|
x |
|
|
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
|
571 |
2-oktyltetrahydroisothiazol-3-on (OIT) |
XX |
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-(xxxxxxxx)-2-(2,4-xxxxxxxxxxxx)xxxxx]xxxxxxxx (xxxxxxxx) |
XX |
252-615-0 |
35554-44-0 |
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x |
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599 |
S-[(6-chlor-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl]-O,O-dimethyl-fosforothioát (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 xxxxxxxx-xxxxxxxxx/xxxxxxxxxxx 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) |
XX |
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 |
cis- x xxxxx-x-xxxxxxx-3,8-xxxx (směs) (citriodiol) |
UK |
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 (permethrin) |
XX |
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) |
BE |
259-154-4 |
54406-48-3 |
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x |
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619 |
3-jodprop-2-yn-1-yl-N-butylkarbamát (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) (THPS) |
XX |
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 |
xxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxx 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 (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 (xxxxxxxxx) |
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 (xxxxxxxxxx) |
XX |
269-855-7 |
68359-37-5 |
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x |
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667 |
xxxxx(X12-18)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (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 (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 |
|
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 |
xxxxx(X12-X18)xxxxxx(xxxxxxxx)xxxxxxxx xxxx 1,1-xxxxx-1λ-1,2-xxxxxxxxxxxxxxx-3(2X)-xxx (XXXXX) |
XX |
273-545-7 |
68989-01-5 |
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x |
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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 |
xxxxx(X10-X16)xxxxxxxxxxxxxxxxx |
PT |
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 |
|
x |
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1015 |
margosa, Xxxxxxxxxxx xxxxxx, xxxxxxx |
DE |
283-644-7 |
84696-25-3 |
|
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|
x |
|
|
|
724 |
alkyl(C12-C14)dimethylbenzylammoniumchlorid (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 |
|
725 |
alkyl(C12-C14)ethylbenzylammoniumchlorid (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, výtažek |
XX |
289-699-3 |
89997-63-7 |
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x |
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744 |
xxxxxxxxx zvrhlá, Xxxxxxxxx hybrida, xxxxxxx/xxxxxxxxxxx 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 xxxxxxxx x X-xxxxx(X12-X14)xxxxxx-1,2-xxxxxxx (glukoprotamin) |
DE |
403-950-8 |
164907-72-6 |
|
x |
|
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) |
XX |
420-590-7 |
4299-07-4 |
|
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x |
x |
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x |
x |
|
|
x |
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792 |
xxxxxxx 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 |
|
x |
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x |
|
x |
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794 |
xxx-xxxxx-2,2-(2-xxxxxxxxxxxx)xxxxxxxxx-1-xxxxxxxxxx (xxxxxxxx) |
XX |
423-210-8 |
119515-38-7 |
|
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x |
|
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|
797 |
1-((Z)-3-chlorallyl)-3,5,7-triaza-1-azoniaadamantanchlorid (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-karboxylát (xxxx xxxxxxxxxxxxx) (imiprothrin) |
XX |
428-790-6 |
72963-72-5 |
|
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x |
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790 |
5-xxxxx-2-(4-xxxxxxxxxxx)xxxxx (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 (chlothianidin) |
XX |
433-460-1 |
210880-92-5 |
|
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x |
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952 |
Xxxxxxxx xxxxxxxxxx 2362, xxxx ABTS-1743 |
XX |
mikroorganismus |
143447-72-7 |
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x |
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955 |
Bacillus xxxxxxxxxxxxx xxxxx. israelensis, xxxx XX3X |
XX |
xxxxxxxxxxxxxxx |
není xxxxxxxxxx |
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x |
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957 |
Xxxxxxxx xxxxxxxx |
XX |
xxxxxxxxxxxxxxx |
xxxx xxxxxxxxxx |
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x |
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|
928 |
5-chlor-2-methylisothiazol-3(2H)-on (Xxxxxx 247-500-7) x 2-methylisothiazol-3(2H)-on (Xxxxxx 220-239-6), směs (3:1) (xxxx CMIT/MIT) |
XX |
xxxx |
55965-84-9 |
|
x |
|
x |
|
x |
|
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x |
x |
x |
|
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|
939 |
xxxxxxx xxxxx (vyráběný xxxxxx xxxxxxxx xxxxxxx x xxxxxxxxx xxxxxxx xx xxxx) |
XX |
xxxx |
xxxx xxxxxxxxxx |
|
x |
x |
x |
x |
|
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|
813 |
peroxyoktanová xxxxxxxx |
FR |
není xxxxxxxxxx |
33734-57-5 |
|
x |
x |
x |
|
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1014 |
xxxxxxxx xxxxxx |
XX |
xxxx xxxxxxxxxx |
xxxx 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 (x-xxxxxxxxx) |
IE |
xxxx xxxxxxxxxx |
188023-86-1 |
|
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x |
|
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|
931 |
xxxxxxxxxxxxxxxxxxxxxxx, X-X12-14(xx xxxxx číslem), xxxxxxxx xxxxxx x xxxxxxxxxxxx xxxxxxxxx (Ampholyt 20) |
XX |
xxxx relevantní |
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 xxxxxxxx xxxxxxxxxx |
XX |
xxxx x xxxxxxxxx |
xxxx k dispozici |
x |
x |
|
|
|
x |
x |
|
x |
x |
x |
|
|
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|
777 |
reakční xxxxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-xxxxx-5-xxxxxxxxxxxxxxxx x xxxxxxx (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 |
|
x |
|
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|
824 |
xxxxxxxx-xxxxxxxxx xxxxxx |
XX |
xxxx x xxxxxxxxx |
130328-20-0 |
|
x |
|
x |
x |
|
x |
|
x |
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|
1013 |
xxxxxxxx-xxxxxxx xxxxxx |
XX |
xxxx x xxxxxxxxx |
130328-19-7 |
|
x |
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x |
x |
|
x |
|
x |
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|
1017 |
stříbro xxxxxxxxxxx xx xxxxx xxxxxxxxxx (xxxx xxxxxxxxxxxx xx xxxxx stabilního xxxxxxxx x xxxxxxxxxx xxxxxxxxx xx nanoúrovni) |
XX |
xxxx x xxxxxxxxx |
xxxx x xxxxxxxxx |
|
|
|
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x |
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|
1019 |
xxxx křemičitý (jako xxxxxxxxxxxx xxxxxxx xxxxxxxx x xxxxxxxxxx) |
XX |
xxxx k dispozici |
68909-20-6 |
|
|
|
|
|
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x |
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|
831 |
xxxxxxxxx |
XX |
xxxxxxxxx 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, 1X: 1R xxxxx, 1S: 1R xxx, 1X: 1X xxx, 1X 4:4:1:1) (x-xxxxxxxxx) |
XX |
xxxxxxxxx xx ochranu xxxxxxx |
231937-89-6 |
|
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|
|
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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 xx xxxxxxx rostlin |
260359-57-7 |
|
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|
|
|
|
|
x |
|
|
|
|
848 |
N-[(6-chlor-3-pyridyl)methyl]-N′-kyan-N-methylethanimidamid (acetamiprid) |
XX |
xxxxxxxxx xx ochranu xxxxxxx |
160430-64-8 |
|
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|
|
|
|
|
|
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|
x |
|
|
|
|
835 |
esfenvalerát/(S)-(3-fenoxyfenyl)kyanmethyl-(S)-2-(4-chlorfenyl)-3-methylbutanoát (xxxxxxxxxxxx) |
XX |
xxxxxxxxx xx xxxxxxx xxxxxxx |
66230-04-4 |
|
|
|
|
|
|
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|
|
|
|
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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 |
xxxxxxxxx xx xxxxxxx rostlin |
67375-30-8 |
|
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|
|
|
|
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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 xxxxxxx xxxxxxx |
122453-73-0 |
|
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x |
|
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|
859 |
xxxxxxx X-xxxxxxxxxxxxxxxxx(XXXXXX 204-697-4) s (xxxxxxxxxxx)xxxxxxxx (XXXXXX 203-439-8)/xxxxxxxxx xxxxxxxxx xxxxxxx xxxxxx (XX Xxxxxxx) |
XX |
xxxxxxx |
25988-97-0 |
|
x |
|
|
|
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|
|
x |
|
|
|
|
|
|
|
|
863 |
poly(biguanid-1,5-diylhexan-1,6-diyl) (XXXX) |
FR |
polymer |
27083-27-8/32289-58-0 |
x |
x |
x |
x |
x |
x |
|
|
x |
|
x |
|
|
|
|
|
|
|
|
868 |
poly(biguanid-1,5-diylhexan-1,6-diyl-hydrochlorid) |
FR |
xxxxxxx |
91403-50-8 |
x |
x |
x |
x |
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869 |
α-[2-(xxxxxxxxxxxxxxxxxxx)xxxxx]-ω-[xxxxxxxxxxx(xxxxxxxxxx)-xxxxxxxxx] (Xxxxxx 26) |
XX |
xxxxxxx |
94667-33-1 |
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872 |
X-xxxxxxx-X-xxxxxxxxxxxxxxxxxxxx-xxxxx/ α, α ′-(xxxxxxxxxxxxx)xxx[ω-xxxxxxxxx(xxxxxxxxxx)]-xxx xx (xxxxxxxxxxx xxxxxx) |
XX |
polymer |
214710-34-6 |
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x |
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XXXX 2
Xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx nepodporované xx dni 4. xxxxx 2014
Xxxx xxxx xxxx xxxxxxx xxxxxxxx
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— |
kombinace xxxxx a typu přípravku xxxxxxx x xxxxxxx xxxx, xxxxxx případných xxxxxxxxx, |
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xxxxxxxx xxxxxxxxx všech kombinací xxxxx a typu přípravku xxxxxxxxx x xxxxxxx x xxxxx 1, xxxxx těch, xxxxx xxxx uvedeny x xxxxxxx, x |
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xxxxxxxx nanoformy xxxxx xxxxxxxxx xxxxxxxx xxxxx x xxxx přípravku schválených xx 4. xxxxx 2014, x xxxxxxxx xxxx, xxxxx xxxx xxxxxxxx xxxxxxxxx. |
Kombinace xxxxx a typu přípravku x xxxxxxxxxxxxx xxxxxxxx xx xxxx části xxxxx předmětem rozhodnutí x xxxxxxxxxxx xxxxx xxxxxx 20, xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxx xx xxxxxxxx xxxxxx xx vstupu tohoto xxxxxxxx x xxxxxxxx xxxxx xx. 14 xxxx. 3 xxxx xxxxx xx takové xxxxxxxx xxxxxxxxx xxxxx xx. 17 xxxx. 4 xxxx 5.
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Xxxxx xxxxxxx |
Xxxxx xxxxx |
Xxxxxxx xxxx xxxxxxxxx |
Číslo XX |
Xxxxx XXX |
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17 |
18 |
19 |
21 |
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1021 |
1,3-xxxxxxx-5,5-xxxxxxxxxxxxxxxxx (xxxx definovaný xxxxx xxxxxxx 152) |
NL |
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 položka 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 |
xxxxxx(xxxxxxxx)xxxxxxxxxxxxxxxxx-xxxxxxx (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 xxxxxxx 949) |
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219-234-1 |
2390-68-3 |
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384 |
xxxxxxxx(xxxxxxx)xxxxxxx-xxxxxxx (viz položka 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 amorfní |
XX |
231-545-4 |
7631-86-9 |
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449 |
xxxxx xxxxxxx |
XX |
231-847-6 |
7758-98-7 |
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1016 |
xxxxxxx stříbrný |
XX |
232-033-3 |
7783-90-6 |
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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 (viz 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 odvozen od xxxxxxxx xxxxxxx xxxxxxxxxx xxxxx) (xxx xxxxxxx 948) |
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263-080-8 |
61789-71-7 |
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638 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxxx xxxxxxx xx xxxxxxxx xxxxxxx xxxxxxxxxx xxxxx) (xxx 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 xxxxxxx loje) (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 |
xxxxxxx(X6-X12)xxxxxxxxxxxxxxx-xxxxxxxx (xxx xxxxxxx 949) |
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269-925-7 |
68391-06-0 |
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670 |
alkyl(C8-C16)benzyl(dimethyl)amonium-chloridy (xxx xxxxxxx 948) |
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270-324-7 |
68424-84-0 |
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689 |
alkyl(C10-C16)benzyl(dimethyl)amonium-chloridy (xxx položka 948) |
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273-544-1 |
68989-00-4 |
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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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697 |
xxxxxxx(X8-X18)xxxxxxxxxxxxxx-xxxxxxxx (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 indica xxxxxxxxxxx xxxxx x xxxx xxxxxxxxxx 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) |
NL |
401-570-7 |
89415-87-2 |
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x |
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778 |
1-(4-chlorfenyl)-4,4-dimethyl-3-[(1H-1,2,4-triazol-1-yl)methyl]pentan-3-ol (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 xxxxxxxxx xxxxxx (xxxxxxxx) |
XX |
432-790-1 |
xxxx relevantní |
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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) (alkyly (X6-X18) nasycené x xxxxxxxxxx, odvozené xx xxxxxxxx xxxxxxx xxxx, xxxxxxxxxx oleje a xxxxxxxx oleje) (XXXX) |
IT |
směs xxxxx xxxxxxxxx v 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 |
xxxxxxxxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx xxxx -xxxxxx-xxxxxxx) (xxxxxx (X8-X18) xxxxxxxx x nenasycené, odvozené xx mastných kyselin xxxx, kokosového oleje x xxxxxxxx oleje) (XXXX) |
XX |
xxxx xxxxx uvedených x xxxxxxx XXXXXX |
xxxx xxxxxxxxxx |
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x |
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948 |
xxxxxx(xxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -bromidy xxxx -xxxxxxxxx) (xxxxxx (C8-C22) xxxxxxxx a nenasycené, xxxxxxxx xx mastných xxxxxxx xxxx, xxxxxxxxxx xxxxx a sójového xxxxx) (XXX) |
XX |
xxxx xxxxx xxxxxxxxx x seznamu 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 (d-fenothrin) |
XX |
xxxx xxxxxxxxxx |
188023-86-1 |
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x |
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1001 |
xxxxx(X12-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxx xxx xxxxx xxxxxxxxx xxx položku 671) |
XX |
xxxx xxxxxxxxxx |
není xxxxxxxxxx |
x |
x |
x |
x |
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x |
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x |
x |
x |
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1002 |
xxxxx(X12-X18)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx(xxxx xxx látka spadající xxx položku 667) |
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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1003 |
alkyl(C12-C18)(ethylbenzyl)dimethylamonium- xxxxxxxx (xxxx xxx xxxxx xxxxxxxxx xxx xxxxxxx 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 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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1006 |
xxxxxxxxxxxxxx xxxx obsahující xxxxxxx, xxxxx, hliník 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 |
dialkyl(C8-C10)dimetylamonium-chloridy (xxxx xxx xxxxx xxxxxxxxx xxx xxxxxxx 673) |
IT |
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 (xxxxx xxxxxxx xx xxxxxxxx xxxxxxx xxxxxxxxxx xxxxx) (xxxx xxx xxxxx xxxxxxxxx xxx xxxxxxx 635) |
XX |
xxxx xxxxxxxxxx |
není xxxxxxxxxx |
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x |
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1012 |
xxxxxxxxxxxxxxxxx xxxxx, stříbrný x xxxxxxxxx komplex/stříbrno-zinečnatý zeolit |
SE |
xxxx 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 technický) |
DE |
xxxxxxxxx xx xxxxxxx rostlin |
73790-28-0 |
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x |
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XXXXXXX XXX
Xxxxx
|
Xxxx xxxxxxxxx |
Xxxxx pro xxxxxxxxxx xxxxxxxxx zprávy xxxxx čl. 6 xxxx. 3 xxxx. x) |
Xxxxx xxx zahájení xxxxxxxx xxxxxxxxxx xxxxx xx. 7 xxxx. 2 xxxx. x) |
|
8, 14, 16, 18, 19 a 21 |
31.12.2015 |
31.3.2016 |
|
3, 4 x 5 |
31.12.2016 |
31.3.2017 |
|
1 a 2 |
31.12.2018 |
31.3.2019 |
|
6 x 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 |