XXXXXXXX KOMISE X XXXXXXXXX XXXXXXXXX (EU) x. 1062/2014
xx xxx 4. xxxxx 2014,
týkající se xxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx obsažených x xxxxxxxxxx přípravcích, xxxxx xxxx xxxxxxx x xxxxxxxx Evropského xxxxxxxxxx x Xxxx (EU) x. 528/2012
(Text x xxxxxxxx xxx XXX)
XXXXXXXX XXXXXX,
s ohledem xx Xxxxxxx x xxxxxxxxx Evropské xxxx,
x xxxxxxx xx xxxxxxxx Xxxxxxxxxx parlamentu x Rady (EU) x. 528/2012 ze xxx 22. května 2012 o dodávání xxxxxxxxxx xxxxxxxxx xx xxx a jejich xxxxxxxxx (1), x xxxxxxx xx xx. 89 xxxx. 1 xxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx,
xxxxxxxx x xxxxx xxxxxxx:
(1) |
Xxxxxxxx Xxxxxx (XX) č. 1451/2007 (2) xxxxxxx xxxxxxxxx xxxxxxxx xxx xxxxxxx xxxxxxxx xxxxxxxxxxx biocidních xxxxxxxx xxxxx (dále xxx „xxxxxxx xxxxxxxx“), xxxxx xxx xxxxxxx x xxxxxxx x xx. 16 xxxx. 2 směrnice Xxxxxxxxxx xxxxxxxxxx a Rady 98/8/XX (3). Protože xxxx xxxxxxxx xxxx xxxxxxx x xxxxxxxxx xxxxxxxxx (XX) x. 528/2012, xxxx by xxx xxxxxxxxx xxxxxxxx xxx pokračování xxxxxxxx xxxxxxxx přizpůsobena xxxxxxxxxxx xxxxxxxxx nařízení. |
(2) |
Xx xxxxxxxx xxxxx kombinace účinné xxxxx x xxxx xxxxxxxxx, xxxxx xxxxx xxx xxxxxxxx xx xxx x xxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxxxx xxxxxx 89 xxxxxxxx (XX) x. 528/2012 x xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx. Mělo xx xxxx xxx x x xxxxxxx xxxxxxxxx účinné xxxxx x typu xxxxxxxxx, xxxxx xxxx hodnoceny x programu xxxxxxxx. |
(3) |
Xxxxx xxxxxxxxx využíval odchylky xxx xxxxxxxxx x xxxxxx xxxxx xxxxxx 6 xxxxxxxx (ES) x. 1451/2007, xxx xxxxxxxxxx se xx xxx xxxxxxx xxx xxxxxxxxx a krmiva xxxxxxx x xx. 2 xxxx. 5 xxxx. x) nařízení (EU) x. 528/2012, měly xx xxx xxxxxx xxxxx, xxxxx obsahuje, xxxxxxxxx x xxxxxxxx xxxxxxxx pro xxxxxxxxx typ xxxxxxxxx. X xxxxxxxx xxxxxxxxxxxxxx předpisů xx xxxx být xxxxxx xxxxxxxx xx xxx x xxxxxxxxx umožněno xx xx xxxxxxxx xxxxxxxxx xxxxxxxxx. Xxxxxx xxxxxxxxxxx xxxxxxxxxx xx xxx vymezit, xxxxx xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxx. Xxxxx xx mělo xxxxxx x xxxxxxxxx, xxx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx x nové definice xxxx přípravků x xxxxxxxx (XX) x. 528/2012 oproti xxxxxxxx uvedené xx xxxxxxxx 98/8/ES xxxx xx xxxxx odůvodněno xxxxxxxxxxx Xxxxxx xxxxxxxx x xxxxxxx s čl. 3 xxxx. 3 xxxxxxxx (XX) x. 528/2012, xxxxxxxxxxx (xxxxxxxxx xxxxxxxxxxx xx věci X-420/10 (4)) xxxx závaznými xxxxxx Xxxxxx xx xxxxxxxxxxx xxxxxx členských xxxxx, xxxxx xx následně xxxxxxx. |
(4) |
Xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxx látku, xxxxx xxx xxxx xxxxxxxx xx xxxxxxxx xxxxxxxx, z xxxx xxxxx sestává nebo xx x ní xxxxxx, xxxxx xxxxxxxx xx xxxxxxxxx tohoto xxxxxxxxxx xxxxxxxxx v členském xxxxx nezbytné, mělo xx být x xxxxx xxxxxxxx státě xxxxxxx x xxxxxxxx na trh xxxxxxxx na jeho xxxxxxxxxxxx, xx xxxxxxxx xxxxxxxx x xx xxxxxxxx xxxx. |
(5) |
X xxxxx jednotnosti x xxxxxxxxxxxx xx měl xxx xxxxxx xxxxxxxxx xxxxxxxx látek v programu xxxxxxxx ve xxxxx xxxxxxxxxx částech totožný x xxxxxxxx stanoveným xxx xxxxxxx xxxxxxxxxx xxxxx xxxxxx 7 xxxxxxxx (XX) x. 528/2012 xxxx xxxxx xxxxxxxxxxx xxxxxxxx Xxxxxx (XX) x. 88/2014 (5). |
(6) |
Xxx xxxxx, které xxxxxxx xxxxxxxx xxxxxxxxx nebo xxxxxxxx xxx xxxxxxx, xx měl xxxxxxxxx xxxxxxxxx orgán xxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxxxxx a označení látky xxxxx xx. 37 xxxx. 1 xxxxxxxx Evropského xxxxxxxxxx x Xxxx (ES) č. 1272/2008 (6), xxxxx jde x xxxxxxxxx xxxxxxxxxx vzbuzující xxxxx, a zároveň xx xxxx xxx zachováno xxxxx xxxxxxxxx státu xxxxxxxxx xxxxx xxxxxxxx xx xxxxxx xxxx xxxxx xxxxxxxxxxx vlastností. Xxxxxxxxx příslušný xxxxx xx xxx xxxx xxxxxxxxxxx xxxxxxxx x xxxxxxx xxxxx, které xx splňovaly xxxxxxxx xxx xxxxx perzistentní, xxxxxxxxxxxxxxx či toxické, nebo xxxxx, xxxxx xx xxxxx být xxxxxxxxxx xx látky s vlastnostmi xxxxxxxxxxxxxx narušení endokrinní xxxxxxxx. |
(7) |
Xxx xxxx xxxxxxxxx, xx program xxxxxxxx xxxx dokončen xx xxxxxxxx data xxxxxxxxx x xx. 89 xxxx. 1 nařízení (XX) x. 528/2012, mělo xx xx hodnocení xxxxxx na kombinace xxxxxx látky a typu xxxxxxxxx, x nichž xxxx xxxxxxxxx xxxxx xxxxxxxxxx xx xxxxxxx stanovených x xxxxxxxx (ES) x. 1451/2007 xxxx v tomto xxxxxxxx. Xxxxx xxxx xx xx měly stanovit xxxxxx xxxxx pro xxxxxxxxx xxxxxxxxx, xxxxxxx xx xx xxxx xxxx v úvahu xxxxxxx, xx žádosti xx xxxxx xxx xxxxxxxxx méně xxx xxx xxxx uplynutím xxxxxx xxxx. |
(8) |
Ohledně xxxxxxxx xx xxxxxxx I xxxxxxxxx 7 xxxxxxxx (XX) č. 528/2012 dosud xxxxxx stanoveny xxxxx xxxxxxxxx xx xxxxx. Xx proto xxxxxx x xxxx xxxx xxxxxx xxxxxxx x xxxxxxxx xx uvedené xxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6. |
(9) |
Bez xxxxxx na čl. 90 xxxx. 2 xxxxxxxx (XX) č. 528/2012 xxxxxxx z článku 91 xxxxxxxxx nařízení, xx xxxxxxxx xxxxxxx x xxxxxx 10 xxxxxxxxx xxxxxxxx xx xxxx xxx xxxxxxxxxx xxx xxxxxxxx povolování xxxxxxxxxx přípravků xx xxxxx xxxxxxxxx. Xx proto xxxxxx xxxxx xxxxx xxxxxxxxx tato kritéria xx xxxxx xxxxxxxxxxx účinných xxxxx. |
(10) |
Xxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xx měl xxx možnost xx xx xxxxxxxx xxxxxx xxxxxxxx ke xxxxxxxxxxx xxxxxxxxxxx nebo xxx xxxxxxxx za xxxxxxxxxxx, xx xxxxx xxxx xxxxxxx xx zpoždění xxxxxxxxx x xxxxxx xxxxxxxxx xxxxxxxx x xxxxxx, xxxxxxx xxxxx by xxxxxxxxxxx xxxxxxxx musel xxxxxxxxx xxxxx znovu. |
(11) |
Xxxxxxx xx účast x xxxxxxxx xxxxxxxx dobrovolná, mělo xx xxx xxxxxxxxxx xxxxxxxx xx xx xxxxxxxxx. Pokud k xxxx dojde, xxxx xx mít xxxxxxxxxxx xxxxxxxxx xxxxxxx převzít xxxxxxx, xxxxxx-xx xxxx xxxxxxxx xxxxxxx xxx xxxxxx, neboť xxx xxxxxxx xx xxxxxxxx xxxxxxxx xxxxxxxx, a xxxxxxxx-xx xxxxxxxx xxx xxxxxxxx xx xxxx xxxxxxxxxx. |
(12) |
Xxxxx xx při xxxxxxxxx účinné xxxxx xxxxx, že identita oficiálně xxxxxxxx xx xxxxxxxx xxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxx hodnocené látky, x x xxxxxxxxx xxxxx xxxxxxx xxxxxx xxxxxxx xxxxxxxx xxxxxxxxx zařazené xxxxx, mělo xx xxx možné tuto xxxxx x xxxxxxx xxxxxxxxx xxxxx xxxxxxxxx x xxxxxxx xxxxx xxxxxx, aby xxxxxxxx xxxxxxx této xxxxxxxxx xxxxxxxx xxxxx. |
(13) |
Xxxxxxx xxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxxxxx x době přijetí xxxxxx xxxxxxxx podporovány xxxxxx účastníkem. Xxxxx xx xxxx xxxxxxxx xxxxxxxxxxxxx, xxxxxx podle xx. 4 xxxx. 4 xxxxxxxx (XX) x. 528/2012 tyto xxxxxxxxx nelze schválit, xxxxx xxx není xxxxxxxx xxxxxxxxx. X xxxxxxxxx látek x xxxxxxxxxxxxx by měly xxx xxxxx xxxxxxx xxxxxxx xxxxx, xxxxxxx xxxxx by tyto xxxxx x xxxxxxxxxxxxx xxxxxx xxx x xxxxxxxx xxxxxxxx xxxxxxxxx. |
(14) |
Xxx xxxx xxxxxxxxx, že žádná xxxxx nezůstane v xxxxxxxx xxxxxxxxxxx xxx xx xxx nebude xxxxxxxx, aniž xx xxxxxxxx xxxx xxxxxxxxxxx, xxxx xx xxxxxxxx xxxxx, xxxxx xxxxx xxxxxx xxxxxxxxx, x xxxxxxxx nebo xxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxx x xx, |
XXXXXXX XXXX NAŘÍZENÍ:
XXXXXXXX 1
XXXXXXX X XXXXXXXX
Xxxxxx 1
Xxxxxxx
Xxxx xxxxxxxx xxxxxxx xxxxxxxx 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
Xxx xxxxx xxxxxx xxxxxxxx xx xxxxxxx xxxx xxxxxxxx:
x) |
„xxxxxxxxxxx x xxxxxxxxxxx“ se xxxxxx xxxxxxxxxx neschválit xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxx xx. 9 xxxx. 1 xxxx. x) nařízení (XX) č. 528/2012 xxxx xx. 89 xxxx. 1 xxxxxxx xxxxxxxxxxx xxxxxxxxx nařízení, xxxx xxxxxxxxx xxxxxxxxx xx xxxxxxx I nebo IA xxxxxxxx 98/8/XX; |
b) |
„kombinací xxxxx x xxxx xxxxxxxxx zařazenou xx xxxxxxxx xxxxxxxx“ xx xxxxxx xxxxxxxxx látky x xxxx přípravku xxxxxxx x xxxxxxx II, xxxxx xxxxxxx xxxx xxxxxxxx:
|
x) |
„účastníkem“ xx xxxxxx osoba, xxxxx xxxxxxxxxx xxxxxx o xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx nebo xxxxxxxxxx xxxxxxxx, xxxxx odpovídá xxxxxxxxxx podle čl. 17 xxxx. 5 xxxxxx xxxxxxxx, xxxx xxxxxx jménem xxxx xxxx xxxxxx xxxx oznámení xxxxxxxxxx; |
x) |
„xxxxxxxxxx xxxxxxxxxx orgánem“ se xxxxxx příslušný xxxxx xxxxxxxxx státu xxxxxxxxx x xxxxxxx XX xxxxxx nařízení, xxxxxx x xxxxxxx x xxxxxxx 81 xxxxxxxx (XX) x. 528/2012. |
XXXXXXXX 2
XXXXXX XXXXXXXXX XXXXXXXXXXX
Xxxxxx 3
Xxxxxx x xxxxxxxxx xxxx zařazení xx xxxxxxx X xxxxxxxx (EU) 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 pouze xxxxxxxx, x xxxxx xxxxxxxx xxxxx xxxxxxxx x xxxxxx, xx xxxxxxxx xxxxxxxxxx xxxxx xx.&xxxx;17 xxxx.&xxxx;5 xxxxxx xxxxxxxx.
Xxxxx xx xxxxxx xxxx xxxxxxxx do přílohy X&xxxx;xxxxxxxx (XX) x.&xxxx;528/2012, může xx xxxxx xxxxx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx xxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxx uvedené x&xxxx;xxxxxxxx 1 se xxxxxxxx xxxxxxxx do dvou xxx xx prohlášení x&xxxx;xxxxxxx x xxxxxxxxx xxxxx xx.&xxxx;17 odst. 5.
Xxxxxx 4
Xxxxxxx xxxxxxx
1. Xxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxx xxxxxxxx podle xxxxxxxxxxx nařízení Xxxxxx (XX) x. 564/2013 (7) x zamítne xxxxxx, xxxxx účastník xxxxxxxxx xxxxxxxx xx xxxxx 30 xxx. X xxxx xxxxxxxxxxx informuje xxxxxxxxx x hodnotící xxxxxxxxx xxxxx.
2. Po obdržení xxxxxxxx splatných podle xxxxxxxxxxx xxxxxxxx (EU) x. 564/2013 xxxxxx xxxxxxxx žádost x xxxxxxxxx x xxx xxxxxxxxx x xxxxxxxxx xxxxxxxxx orgán, xxxxxxx xxxxx datum xxxxxxx xxxxxxx a její xxxxxxxxx xxxxxxxxxxxxx xxx.
3. Xxxxx xxxxxxxxxxx agentury podle xxxxxxxx 1 xxxxxx xxxxxx xxx xxxxx xxxxxxx xxxxxxxxxx x xxxxxxx x xxxxxxx 77 nařízení (XX) x. 528/2012.
4. Xxxxxxxxx příslušný xxxxx informuje účastníka x xxxxxxxx xxxxxxxx xxxxx čl. 80 xxxx. 2 xxxxxxxx (XX) x. 528/2012 xx 30 xxx xxxx, xx xxxxxxxx xxxxxxx xxxxxx, x xxxxxxx xxxxxx, pokud xxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxx 30 xxx. X xxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x agenturu.
Xxxxxx 5
Xxxxxxxxx žádostí x schválení xxxx xxxxxxxx xx kategorie 6 přílohy I xxxxxxxx (XX) x. 528/2012
1. Xxxxx xxxxxxxx xxxxxx xxxxx xx. 4 xxxx. 2 xxxxxx x xxxxxxxxx nebo xxxxxxxx xx xxxxxxxxx 6 xxxxxxx X xxxxxxxx (XX) x. 528/2012, xxxxx xxxxxxxx xxxxx xxxxxxxxxx v souladu x xx. 6 xxxx. 1 a 2 xxxxxxxxx nařízení, a byl xxxxxxxx xxxxxxxx xxxxx xx. 4 odst. 4, xxxxxxxxx xxxxxxxxx xxxxx xxxxxx xxxxxxx xx 30 xxx xx xxxxxxxxx xxxxxxxx.
2. Pokud xxxxxxxxx příslušný orgán xxxxxxx od účastníka xxxxxxxxxxx xxxxx xxxxxxxx (XX) x. 1451/2007, xxxxx xx xxxxx xxxxxx uznána xxxx úplná podle xxxxxx 13 xxxxxxxxx xxxxxxxx, xxxxxxx xxxxxxxxx xxxxxxxxx xxxxx žádost xxxxxxxxxx xx 3. xxxxx 2015.
3. X xxxxxxxxx uvedených x xxxxxxxxxx 1 x 2 hodnotící xxxxxxxxx xxxxx neprovádí xxxxxxxxx xxxxxxx ani xxxxxxxxxxxx předložených xxxxx xxxx odůvodnění.
4. Pokud xxxxxxxxx xxxxxxxxx xxxxx xxxxxx, xx žádost xx xxxxxxx, sdělí xxxxxxxxxxx, xxxx xxxxxxxxxx xxxxxxxxx xxxx x xxxxxxxxx xxxxxxx xxxxx, x x xxxxxxxxxx xxxxxx xxxxxxxxx stanoví xxxxxxxxxx xxxxx. Xxxx xxxxx xxxxx xxxxxxxxxx 90 xxx.
Rozhodne-li xxxxxxxxx xxxxxxxxx xxxxx, xx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx postačují xx xxxxxxx xxxxxxxxx xxxxxxxxx x odstavci 2, xxxxxxx xxxxxx xx 30 xxx xx xxxxxxxx doplňujících xxxxxxxxx.
Jestliže xxxxxxxx xxxxxxxxxx xxxxxxxxx xx stanovené xxxxx xxxxxxxxxx, hodnotící příslušný xxxxx xxxxxx zamítne x xxxxxxxxx x xxxx skutečnosti xxxxxxxxx x agenturu. X xxxxxx xxxxxxxxx se xxxxx poplatky xxxxxxxxx x xxxxxxx x xx. 80 xxxx. 1 x 2 xxxxxxxx (EU) x. 528/2012.
Xxx potvrzení xxxxxxx xxxxxxxxx xxxxxxxxx orgán xxxxxxxxxx informuje xxxxxxxxx, xxxxxxxx a další xxxxxxxxx xxxxxx x xxxxx datum xxxxxx xxxxxxxxx.
Xxxxxx 6
Hodnocení xxxxxxx
1. Xxxxx xxxxxx xx použije, xxxxx xxxxx xxxxxxx x xxxxxx podmínek:
x) |
xx-xx xxxxxx xxxxxxxxx podle xxxxxx 5; |
x) |
xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxx dokumentaci xxxx úplnou podle xxxxxx 13 nařízení (XX) x. 1451/2007, ale xxxxx xxxxxxxxxxx Komisi zprávu xxxxxxxxxxx xxxxxx xxxxx xx. 14 xxxx. 4 uvedeného xxxxxxxx; |
x) |
xxxxx agentura xxxxxxx xxxxxx o xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4 xxxx 5 přílohy X xxxxxxxx (XX) č. 528/2012 xxxxx xx. 4 xxxx. 2 x xxx xxxxxxxx xxxxxxxx xxxxx čl. 4 xxxx. 4. |
2. Xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx xxxxxx xxxxx xxxxxx 4 a 5 xxxxxxxx (EU) x. 528/2012 x xxxxxxxx xxx veškeré xxxxxx xx xxxxxx xxxxxxxxx xx údaje xxxxxxxxxx x souladu s xx. 6 xxxx. 3 uvedeného nařízení x zašle xxxxxxxxx xxxxxx a xxxxxx xxxxx hodnocení agentuře.
3. Pokud xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx xxxxxxx účastníků, xxxxxxxxx hodnotící příslušný xxxxx pouze xxxxx xxxxxxxxx xxxxxx. Xxxxxxxxx xxxxxx x xxxxxx xxxxx x xxxxx x xxxxxx xxxx, podle toho, xx xxxxxxx xxxxxxx:
x) |
365 xxx xx xxxxxxxxx xxxxxxxxx xxxxxxxx x xxxx. 1 xxxx. x), xxxxxx úplnosti xxxxxxxx x xxxx. 1 písm. b) xxxx zaplacení xxxxxxxx xxxxxxxxx v odst. 1 xxxx. x) x xxxxxxx xxxxxxxxx xxxxx x xxxx přípravku; |
x) |
xx xxxxx xxxxxxxxx x xxxxxxx XXX. |
4. Xxxx tím, xxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx své xxxxxx xxxxxxxx, xxxxxx xxxxxxxxxxx xxxxx xx 30 xxx k xxxxxxxxx xxxxxx x x xxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx. Xxxxxxxxx xxxxxxxxx xxxxx xxxx xxxxxxxxxx xxxxxxxxxxxxx způsobem zohlední x xxxxxxxxx xxxx xxxxx xxxxxxxxx.
5. Xxxxx xx xxxxx, xx xxxx x xxxxxxxxx xxxxx xxxxxxxxxx xxxxxxxxx, xxxxxxxxx xxxxxxxxx orgán xxxxxxxxx xxxxx, xxx xxxx xxxxxxxxx ve stanovené xxxxx xxxxxxxxx, x xxxxxxxxx x xxx xxxxxxxx.
Xxxxx 365 dnů xxxxxxx x xxxxxxxx 3 se xxxxxxx xx xxxx ode xxx xxxxxxxx xxxxxxxxx xx xxx xxxxxxxx xxxxxxxxx. Pokud xx xxxx xxxxxxxxxx xxxxxxx xxxxxxxxxxxx údajů xxxx xxxxxxxxxxx xxxxxxxxxx, xxxxxxxxx xxxxxxxxxx xxxxxxxxxxx lhůty:
x) |
365 xxx v případě, že xx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxxx, xxxxx xxxxxx xxxxxx v xxxxx směrnice 98/8/XX xxxx x xxxxx xxxxxxx xxxxxxxxxxx pro xxxxxxxxxxx xxxxxxx směrnice; |
x) |
180 dní xx xxxxx xxxxxxxxx xxxxxxxxx. |
6. Xxxxx xxxxxxxxx xxxxxxxxx orgán xxxxxx, xx xxxxxxxx xxxxx ohledně xxxxxx xxxx xxxx zvířat xxxx xxxxxxxxx xxxxxxxxx vyplývající x xxxxxxxxxxxxx xxxxxx plynoucích x xxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxxxxx stejné xxxx xxxxxxxx xxxxxx látky, xxx xxxxx xxxxxxxxxxxx x xxxxxxx s požadavky příslušných xxxxx xxxxxx XX xxxx 3 xxxxxxx XX xxxxxxxx Evropského xxxxxxxxxx a Rady (XX) č. 1907/2006 (8) x xxxxxx xx xx xxxxx xxxxxx.
7. X případě potřeby xx dokončení xxxxxxxxx xxxxxxxxxxxxx hodnotící příslušný xxxxx xxx xxxxxxxxxx xxxxxxx x xxxxxxxxxx xxx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx odstavce 3:
x) |
xxxxxxxx xxxxx agentuře xxxxx xx. 37 xxxx. 1 xxxxxxxx (XX) č. 1272/2008, jestliže xx xxxxxxx, xx xx xxxxxxx jedno x xxxxxxxx xxxxxxxxx x xx. 36 xxxx. 1 xxxxxxxxx xxxxxxxx, xxx xxxx náležitě xxxxxx x xxxxx 3 xxxxxxx XX xxxxxxxxx xxxxxxxx; |
x) |
xxxxxxxxxx s agenturou, xxxxx xx xxxxxxx, xx xxxxx z kritérií xx. 5 xxxx. 1 písm. d) nebo x) xxxxxxxx (EU) x. 528/2012 xxxx xxxxxxxx xx. 10 xxxx. 1 písm. d) xxxxxxxxx xxxxxxxx xxxx xxxxxxx, xxx xxxxxx xxxxxxxx xxxxxx v příloze XXX xxxxxxxx (XX) x. 1907/2006 xxxx v seznamu xxxxxxxx x xx. 59 odst. 1 xxxxxxxxx xxxxxxxx. |
Xxxxxx 7
Xxxxxxxxxx xxxxxxxx
1. Xxxxx xxxxxx xx použije, xxxxx xxxxx některá x xxxxxx xxxxxxxx:
x) |
xxxxx hodnotící xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx xxxxxx xxxxx xx. 6 odst. 2 x xxxxxxxx předložil xxxxx xxxx xxxxxxx konzultaci xxxxx xx. 6 odst. 7; |
x) |
pokud xxxx xxxxxxxxxx Xxxxxx xxxxxx xxxxxxxxxxx xxxxxx xxxxx xx. 14 odst. 4 xxxxxxxx (ES) č. 1451/2007, xxx hodnotící xxxxxx xxxxx nepřezkoumal Xxxxx xxxxx xxx xxxxxxxx xxxxxxxxx xxxxx xx. 15 xxxx. 4 uvedeného xxxxxxxx. |
2. Xx xxxxxxx xxxxxx agentura xxxxxxxxx a předloží Xxxxxx xxxxxxxxxx o schválení kombinace xxxxx a typu xxxxxxxxx xxxx xxxx xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx X xxxxxxxx (XX) č. 528/2012, xxxxxxxx xxxxxx, x xxxxxxx xx xxxxxx hodnotícího příslušného xxxxxx.
Xxxxxxxx xxxxxx přípravu xxxxxxxxxx v jedné x xxxxxx xxxx, xxxxx toho, xx xxxxxxx později:
x) |
xx xxx měsíců xx xxxxxxx xxxxxx; |
x) |
xx xxxxx xxxxxxxxx v příloze XXX. |
Agentura xxxxxxxx xxxxxxxxxx Komisi xx 270 xxx xx xxxxxxxx xxxxxxxx.
Xxxxxx 8
Účinné xxxxx, xxxxx xx xxxx xxxxxxxx
1. Xxx xxxxxxxx xxxxx xxxxxxxxxx xxxxx xx. 7 xxxx. 2 xxxxxxxx xxxxxxx, xxx účinná xxxxx xxxxxxx některé x xxxxxxxx xxxxxxxxx v čl. 10 xxxx. 1 xxxxxxxx (EU) č. 528/2012, x xxxx otázku xxxxx xx xxxx xxxxxxxxxx.
2. Xxxx xxxx xxxxxxx xxxxxx 66 x 67 nařízení (EU) x. 528/2012, xxxxx xxx xxxxxxxx předloží xxx xxxxxxxxxx Xxxxxx, zveřejní xxxxxxxxx o možných látkách, xxxxx se xxxx xxxxxxxx, xxxxx xxxxxxxxx 60 xxx; x xxxx xxxx xxxxx xxxxxxxxxx xxxxx xxxxxx xxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxxx. Xxxxxxxx xxxxxxxx xxxxxxxxx náležitě zohlední x xxxxxxxxx xxxx xxxxxxxx xxxxx xxxxxxxxxx.
3. Pokud xx xxxxxx xxxxx xxxxxxxxx x xxxxxxx xxxxx x xxxxxxxx stanovených v čl. 10 xxxx. 1 xxxxxxxx (EU) x. 528/2012, xxxx xxx xxxxxxxx za xxxxx, xxxxx xx xx xxxxxxxx, x xxxxxxxx přijatém x xxxxxxx x xx. 89 odst. 1 xxxxxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxx.
Xxxxxx 9
Xxxxxxxxxx Xxxxxx
Xx xxxxxxxx stanoviska agentury xxxxx xx. 7 xxxx. 2 Xxxxxx bez xxxxxxxxxx xxxxxxxx xxxxxxxx návrh xxxxxxxxxx xxx xxxxxxx xxxxx čl. 89 odst. 1, xxxx xxxxxxxx podle xx. 28 xxxx. 1 nařízení (XX) č. 528/2012.
KAPITOLA 3
ZMĚNY PRVKŮ XXXXXXXX XXXXXXXX
Xxxxxx 10
Xxxxxxxxx xxxx xxxxxxxxx xxxxxxxxx xx vzájemné dohodě
1. Roli xxxxxxxxx je možno xx xxxxxxxx xxxxxx xxxx xxxxxxxxxx účastníkem x potenciálním xxxxxxxxxx xxxxxxx nebo xxxxxx xx předpokladu, xx xx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx se xx xxxxxxx údaje xxxxxxxxxx nebo xxxxxxx xxxxxxxxxx xxxxxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxxx xxx xxxxx tohoto článku xxxxxxxxxxx xxxxxxxx společně xxxxxxxxxxx x&xxxx;xxxxxxxxx účastník xxxxxxxxxxxxxxx xxxxxxxxx xxx xxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxx 71 xxxxxxxx (XX) č. 528/2012 (dále xxx „xxxxxxxx“) a oznámení xxxx xxxxxxxxx všechna xxxxxxxxx xxxxxxxx x xxxxxxxx.
3.&xxxx;&xxxx;&xxxx;Xx xxxxxxxx oznámení splňujícího xxxxxxxxx xxxxx odstavce 2 xxxxxxxx xxxxxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxx xxxxxxxx xx totožnosti xxxxxxxxx.
4.&xxxx;&xxxx;&xxxx;Xxxxx xxxxxxx na území Xxxx, xxxxx xxxxxxxx xxxx xxxxxxxxx nebo xx xxxxxxxxx x xxxxxxxxxxx xxxxx tohoto xxxxxx, xx xxx účely xxxxxx 95 nařízení (XX) x.&xxxx;528/2012 xxxxxxxxxx xx xxxxx, xxxxx xxxxxxxxxx dokumentaci xxxx xxxxxxxx x přístupu x xxxxxxxxxxx.
Xxxxxx 11
Xxxxxxxxxx xxxxxxxxx
1. Xx xx xx xx, xx xxxxxxxx xxxxxxxxx x účasti xx xxxxxxx kombinace xxxxx x xxxx přípravku x xxxxxxxx xxxxxxxx, v xxxxxx xxxxxxxxx:
x) |
xxxxx xxxxxxxxxx xxxxxxxx xxxx hodnotící příslušný xxxxx xxxxxxxxxxxxxxx rejstříku x xxxx xxxxxx xxxxxxxxx; |
x) |
xxxxx xxxxxxxxxxx xxxxxx xx xxxxx uvedené x xx. 3 odst. 2; |
c) |
xxxxx jeho xxxxxx xxxx zamítnuta xxxxx xx. 4 odst. 1, xx. 4 xxxx. 4 xxxx xx. 5 xxxx. 4; |
x) |
xxxxx nepředložil xxxxxxxxxx xxxxxxxxx ve xxxxxxx uvedených x xx. 6 xxxx. 5; |
x) |
xxxxx xxxxx xxxxxxxxxx xxxxxxxx hodnotícímu xxxxxxxxxxx xxxxxx nebo xxxxxxxx. |
2. Odstoupení xx považuje za xxxxxxxxx xxxx, xxxxx x xxxx xxxxxxx xx xxxx, xxx xxxxxxxxx příslušný xxxxx xxxxxxxxx xxxxxxxx zprávu xxxxxxxxxxx xxxxxx podle xx. 6 xxxx. 4 tohoto xxxxxxxx.
Xxxxxx 12
Důsledky včasného xxxxxxxxxx
1. Xxxxx xx x xxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx příslušný xxxxx, xxx xxxxxx xxxxxxxx, xxxxxxxxx xx xxxxxxxxx xxxxxxxxx xxxxx bez xxxxxxxxxx xxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxx je x xxxxxxx odstoupení xxxxxxxxxxx xxxxxxxx, aktualizuje informace x xxxxxxxxx xxxxxxxx xx xxxxxxxxxx účastníka.
3. Xxxxx x xxxxxxxx xxxxxxxx xxxx xxxxxxxxxx všichni xxxxxxxxx xxxxxxxxxxx xxxxx kombinaci xxxxx x xxxx xxxxxxxxx x xxxxx xxxx xxxx xxxxxxxxx xxx xxxxxxxx xxxxxxxxx xxxxx xxxxxxxx, xxxxxxxxx x xxx xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx Xxxxxx.
Xxxxxx 13
Nová xxxxxxxx xxxxxxxxx xxxxx
1. Pokud xxxxxxxxx xxxxxxxxx účinné látky xxxxxxxx xxxxxxx xxxxxx xxxxxxxx se xxxxx, xxx jsou xxxxxxx x xxxxxxx XX, hodnotící příslušný xxxxx xx xxxxxxxxxx x xxxxxxxx xxxxxxxxxx xxxxxxx novou xxxxxxxx xxxxx. Xxxxxxxxx příslušný xxxxx o tom xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx x xxxxxxxxx aktualizuje xxxxxxxxx xxxxxxxx xx xxxxxxxx látky.
Xxxxxx 14
Xxxxxxxx xxxx xxxxxxxxx
1. Xxxxxxxx xxxxxxxx xxxxxxxxx xxxxx k xxxxxxxx xxxx xxxxxxxxx xxx xxxxxxxxx xxxxx a typu xxxxxxxxx, pokud nastane xxxxx x xxxxxx xxxxxxx:
x) |
xxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxx xxxxxxxxxx podle xxxxxx 11 x xxxxxx xxxx účastníka xxx xxxxx xxxxxxxxx xxxxxx předtím převzata; |
x) |
xx xxxxxxx xxxx xxxxxxxx xxxxx xxxxxx 13; v tomto xxxxxxx xx xxxxx xxxx xxxxx xx látky, xx xxxxxx xx xxxxxxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX, xxx nikoliv xxxx xxxxxxxx xxxxx. |
2. Do dvanácti xxxxxx xxx dne xxxxxxxxxx xxxxx xxxxxxxx 1 xxxx xxxxxxxxx osoba xxxxxxxxx xxxxxxxx xxx xxxxxxxxx xxxxx xxxxxx 17.
3. Xx xxxxxxxx xxxxxx od data xxxxxx xxxxxx xxxxxxxx x xxxxxxxx xxxx kterákoli xxxxx xxxxxxx kombinaci xxxxx x xxxx přípravku xxxxxxxxx do xxxxx 2 přílohy II xxxxx xxxxxx 17.
Xxxxxx 15
Kombinace xxxxx x xxxx přípravku xxxxxxxxx pro xxxxxxxx xx xxxxxxxx přezkumu
Pokud xxxxxxxx přípravek, xxxxx xxxxx do xxxxxxx xxxxxxxxxx xxxxxxxx (EU) x. 528/2012 x xx xxxxxx na xxx, xxxxxxx xx xxxxxxxxx xxxxxx látky, xxx xxxx xxxxxxxxx ani xxxxxxxx xx programu xxxxxxxx pro xxxxx xxx xxxxxxxxx x xxxx zařazena do xxxxxxx I xxxxxxxxx xxxxxxxx, xxxx látku xxxxxxxx xxxx xx x ní vyrábí, xx uvedená xxxxx xxxxxxxxx xxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxx xxxxxxxxx xxx xxxxxxxxx xx xxxxxxx xxxxxxxxx z těchto xxxxxx:
x) |
xxxxx uvádějící xxxxxxx xx xxx xx xxxxxxxxx xx pokyny xxxx xxxxxxx xxxxxxxxxx xxxxxx Xxxxxx nebo příslušným xxxxxxx xxxxxxxxxx x xxxxxxx x xxxxxxx 26 xxxxxxxx 98/8/XX xxxx xxxxxxx 81 xxxxxxxx (EU) č. 528/2012, xxxxx xx xxxxxxx xxxxxxxxxx xxxxxxxxxxxxxx xxxxxx xxxxx xxxxxxx pokyny xx xxxxxxxxxx x xxxxxxxxxxx, xx xxxxxxx byl xxxxx x xxxxxxxxxx xxxxxxxx 98/8/XX nebo nařízení (XX) č. 528/2012, xxxx xx byl xxxxxxxxx xxx xxxxxxxxx xxxxxx x xxxxxxxxx, xxx xxxxx byla xxxxxx xxxxx xxxxxxxx, a xxxxx xxxx xxxxxxx xxxxxx xx doporučení xxxxxxxx xxxxxxxxxxx x xxxxxxxxxx xxxxxxxx xxxxx xx. 3 xxxx. 3 xxxxxxxx (EU) č. 528/2012 xxxx x xxxxxx, xxxxxxxxx xxxxxxxx zveřejněných Xxxxxx; |
x) |
xxxxx xxxxxxxxx odchylky xxx xxxxxxxxx a krmiva stanovené x xxxxxx 6 xxxxxxxx (XX) č. 1451/2007; |
c) |
xxxxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxx (XX) x. 528/2012 k xxxxxxxxx typu přípravku, xxx xxxx xxxx xxxxx xxxxxxxx 98/8/XX, v důsledku xxxxx xxxxxxxxxx xxxxxx xxxx přípravků x xxxxxxxx xxxxx xxxxxxxxx xx xxxxxxxx xxxxxxxx xxx xxxxxxx xxx xxxxxxxxx, ale xxxxxx xxx xxxx. |
Xxxxxx 16
Xxxxxxxxxx x xxxxx xx xxxxxxxx
1. Xxxxxxxxxx x xxxxx xxxxxxx xxxxx, xxxxx je způsobilá xxx xxxxxxxx do programu xxxxxxxx xxxxx xxxxxx 15, xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx xxxxxxxxx osoba, xxx xx xxxxx xxxxxxx xxxxxxxxx látky x xxxx přípravku, jednomu x xxxxxxxxxxxxx příjemců:
x) |
Xxxxxx xxxxxxxxxx xxxxxxx xxxxxx xx xxxxxxxxxx xxxxxxxxxx xxxx pokynů uvedených x xx. 15 xxxx. x); |
x) |
xxxxxxxx xxxxxxxxxx 30. xxxxx 2015 x xxxxxxxxx xxxxxxxxx x xx. 15 písm. b); |
x) |
Komisi xxxxxxxxxx 30. xxxxx 2015 v xxxxxxxxx xxxxxxxxx x xx. 15 xxxx. x). |
2. Xxxxxxxxxx xxxx xxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx. V případech xxxxxxxxx x xx. 15 písm. x) xxxx prohlášení xxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx, x xxxx xxxxxxx, xx xxxx xxxxxxx xxxxxxx xxxxxxxx v xxx xxxxxxx.
3. Pokud xxxx xxxxxxxxxx učiněno x xxxxxxx xxxxxxxx x xx. 15 písm. x) xxxx x) x Xxxxxx xxxxxxx xx xxxxxxxxxx x xxxxxxxxx státy x xxxxxx, xx xxxxxxxx 6 není xxxxxxxxxx, x xxxxxxxx, že xxxx xxxxxxx xxxxxxxx xxx oznámení xxxxxxx x xx. 15 písm. x), xxxxxxx x xxx xxxxxxxx.
4. Xxxxx xxxx xxxxxxxxxx xxxxxxx x xxxxxxx uvedeném x xx. 15 xxxx. x) xxxx xxxxx Komise xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 3, zveřejní xxxxxxxx xxxx informaci xxxxxxxxxxxxxx xxxxxxxxxx x xxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx. Xxx xxxxx xxxxxx nařízení se xxxxxxxxxx podle xx. 3x xxxx. 3 xxxxxxx pododstavce xxxxxxxx (XX) č. 1451/2007 xxxxxxxx xx zveřejnění xxxxx xxxxxx odstavce.
5. Xxxxxxxxx xxxxx, která xx xxxxx xxxxxxx xxxxxxxxx xxxxx a xxxx xxxxxxxxx, xxx xxxx xxxxxx xxxxx xxxxxx 17 xx xxxxx měsíců xxx xxx xxxxxxxxxx xxxxx odstavce 4.
6. V případech xxxxxxxxx x xx. 15 xxxx. x) x x) xx xxxxxxxxx látky x xxxx xxxxxxxxx považuje xx xxxxxxxxx xxxxxxxxxx a není xxxxxxxxx k xxxxxxx xxxxxxxx, xxxxx xxxx xxxxxxx xxxx xxxxxxxx:
x) |
xxxxxxxxx xxxxxx xxxxx xx xxx zařazena do programu xxxxxxxx; |
x) |
xxxxxxxxxxx předložená xxxxxxxxxxx xxxxxxxxx státu pro xxxxxxxxxx účinnou xxxxx xxx xxxxxxxx xxxxxxx xxxxx, xxxxx xxxx xxxxxxxx xxx xxxxxxxxx xxxx xxxxxxxxx; |
x) |
xxxxxxxx, xxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxxx, xxxxx, xx xx xxxxx o xxxxxxx xxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx. |
Xxxxxx 17
Postup xxxxxxxx
1. Xxxxxxxx xxxxx čl. 14 xxxx. 2 x 3 xxxx xx. 16 xxxx. 5 xx xxxxxxxxxxx agentuře xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxxxxx xxxx být xxxxxxxxxx xx formátu XXXXXX. Xxxx xxxxxxxxx xxxxx xxxxxxx v xxxxxxx I.
3. Pokud xxxx x xxxxxxx XX pro dotyčnou xxxxxxx xxxxx uveden xxxxxxxxx xxxxxxxxx orgán, xxxxxxxxx oznamovatel xxxxxxxx x xxxxx jím vybraného xxxxxxxxxxx xxxxxx, xxxxx xx xxxxxxxx x xxxxxxx x xxxxxxx 81 nařízení (EU) x. 528/2012, a poskytne xxxxxxx xxxxxxxxx dokládající, xx xxxxxxxxx xxxxx xxxxxxxx x xxx, xx dokumentaci xxxxxxx.
4. Xx xxxxxxxx oznámení x tom uvědomí xxxxxxxx Komisi x xxxxxxxxxxxx informuje x xxxxxxxxxx xxxxxxxxx podle xxxxxxxx (XX) x. 564/2013. Xxxxxxxx xxxxxxxxxxx neuhradí xxxxxxxx xx 30 xxx xx přijetí uvedené xxxxxxxxx, xxxxxxxx xxxxxxxx xxxxxxx x uvědomí x xxx xxxxxxxxxxxx x Komisi.
5. Xx xxxxxxxx xxxxxxxx xxxxxxxx xx 30 xxx ověří, xxx xxxxxxxx vyhovuje xxxxxxxxxx xxxxxxxx x xxxxxxxx 2. Xxxxx xxxxxxxx xxxxx xxxxxxxxxx xxxxxxxxxx, poskytne xxxxxxxx xxxxxxxxxxxx xxxxx v xxxxx 30 dnů, xxx xxx xxxxxxxx xxxxxxx xxxx opravil. Xx xxxxxxxx xxxx 30xxxxx xxxxx xxxxxxxx xx 30 xxx xxx xxxxxxxx, xx xxxxxxxx vyhovuje požadavkům xxxxxxxx 2, nebo xxxxxxxx xxxxxxx, a xxx rozhodnutí xxxxx xxxxxxxxxxxx a Komisi.
6. X xxxxxxx x článkem 77 xxxxxxxx (EU) x. 528/2012 proti xxxxxxxxxxx agentury xxxxx xxxxxxxx 4 xxxx 5 xxxxx xxxxxxx xxxxxxxxxx.
7. Xxxxx xxxxxxxx vyhovuje xxxxxxxxxx podle xxxxxxxx 5:
x) |
x xxxxxxx, xx xxxx xxxxxxxx xxxxxxxxxx podle xx. 14 odst. 2 xxxx 3, xxxxxxxx xxxxxxxxxx xxxxxxxxxxx informace x xxxxxxxxx xxxxxxxx se xxxxxxxxxx účastníka x xxxxxxxx xxxxxxxx xxxxx; |
b) |
v xxxxxxx, xx xxxxxxxx bylo xxxxxxxxxx xxxxx xx. 16 xxxx. 5, xxxxxxxx xxxxxxxxxx xxxxxxxxx Xxxxxx, že xxxxxxxxxx xxxx xxxxxxxx. |
Xxxxxx 18
Xxxxxxxx do xxxxxxxx přezkumu
Pokud xx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxxx xx xxxxxxxxx x xxxxxxx x xx. 16 xxxx. 6 xxxx xxxxx xxxxxxxx informuje Xxxxxx x xxxxxxxx xxxxxxxxx x souladu x xx. 17 xxxx. 7 písm. b), zařadí Xxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xx xxxxxxxx xxxxxxxx.
Xxxxxx 19
Xxxxxxxxx x xxxxxxx, které nejsou xxxxxx podporovány v xxxxx xxxxxxxx xxxxxxxx
Pokud xxxxxx xx xxxxx xxxxxxxxx x xx. 16 odst. 5 obdrženo xxxxx xxxxxxxx xxxx xxxxx xxxx xxxxxxxx xxxxxxx xx xxxxxxxx xxxxxx xxxxxxx a následně xxxxxxxxx agenturou xxxxx xx. 17 odst. 4 xxxx 5, xxxxxxxx o tom xxxxxxxxx členské xxxxx xxxxxxxxxxxxxxx xxxxxxxxx x xxxxxxxx xxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx.
Xxxxxx 20
Rozhodnutí Xxxxxx x látkách, které xxxxxx nadále xxxxxxxxxxx x xxxxx xxxxxxxx xxxxxxxx
Xxxxxx připraví xxxxx xxxxxxxxxx o xxxxxxxxxxx xxxxx xx. 89 xxxx. 1 xxxxxxx xxxxxxxxxxx nařízení (XX) č. 528/2012 v těchto xxxxxxxxx:
x) |
xxxxx xxxxxxxx informuje Xxxxxx o včasném odstoupení xxxxxxxxx podle xx. 12 xxxx. 3 xxxxxx nařízení; |
x) |
xxxxx xxxxx xxxxx xxxxxxxx xxxxxxxx ve lhůtách xxxxxxxxxxx x xx. 14 xxxx. 2 nebo 3 xxxxxx xxxxxxxx xxxx xxxxx xxxx xxxxxxxx xxxxxxxxxx x xxxxxxxxx xxxxx čl. 17 odst. 4 xxxx 5; |
x) |
xxxxx xxxx xxxxxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx x xx. 14 xxxx. 2 xxxx 3 xxxxxx xxxxxxxx a byly xxxxxxxx xxxxxxxxx xxxxx xx. 17 xxxx. 5 xxxxxx nařízení, xxx identita xxxxx x xxxxxxxx xxxxxxxx pouze xxxx stávající xxxxxxxx x xxxxxxx XX xxxxxx xxxxxxxx. |
X xxxxxxx xxxxxxxx x xxxxxx pododstavci xxxx. c) se xxxxx rozhodnutí x xxxxxxxxxxx xxxxxxxx xx xxxxxx xxxxx, xx xxxxxx xx vztahuje xxxxxxxxx xxxxxxxx x xxxxxxx XX tohoto xxxxxxxx, xxxxx nikoli xxxxxxxx xxxx xxxxxxxx xxxxxxxxxx x schválení.
KAPITOLA 4
PŘECHODNÁ XXXXXXXX
Xxxxxx 21
Xxxxxxxxx xxxxxxxx pro xxxxx xxxxxxx v článku 15
1. Členský xxxx xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx svého xxxxxxxxxxx xxxxxxx xxxx xxxxx xxxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxxxx xxxxxxxxxx přípravku, který xxxxxxx xx xxxxxxxxx xxxxxx xxxxx uvedené x xx. 15 xxxx. x) a x), xxxx látku xxxxxxxx xxxx x xx vzniká. X xxxxxx xxxxxxxxx:
x) |
xxxxx být xxxxxxxx xxxxxxxxx nadále xxxxxxx xx&xxxx;xxx s účinkem xx&xxxx;24 xxxxxx xx xxxx xxxxxx xxxxxx xxxxxxxx v platnost; |
b) |
stávající xxxxxx xxxxxxxxxx přípravku xxxxx xxx dále xxxxxxxxx xx&xxxx;30 xxxxxx po xxx xxxxxx xxxxxx xxxxxxxx x&xxxx;xxxxxxxx. |
2.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx pokračovat x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx xxxx xxxxx xxxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxxxx xxxxxxxxxx xxxxxxxxx, který xxxxxxx xx xxxxxxxxx xxxxxx xxxxx xxxxxxx v xx. 15 xxxx. x), xxxx xxxxx xxxxxxxx xxxx x xx vzniká. X xxxxxx xxxxxxxxx:
x) |
xxxxx xxx xxxxxxxx přípravek xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;24 měsíců po xx z xxxx xxxxxxxxx xxxxxxxx, xxxxx xxxxxxx xxxxxxx:
|
x) |
xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxx dále xxxxxxxxx xx&xxxx;30 xxxxxx xx té x xxxx uvedených xxxxxxxx, xxxxx nastane později:
|
3.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx xxxx xxxxx dodávání na trh x&xxxx;xxxxxxxxx biocidního přípravku, xxxxx xxxxxxx xx xxxxxxxxx účinné látky xxxxxxxxxx agenturou xxxxx xx. 16 xxxx. 4 xxx xxxxxxxxx xxx výrobku, tuto xxxxx obsahuje nebo x ní xxxxxx. X xxxxxx xxxxxxxxx:
x) |
xxxxx xxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx od dvanácti měsíců xx xxxx, kdy xxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxx xxxxxx 19 a |
b) |
stávající zásoby xxxxxxxxxx přípravku mohou xxx xxxx využívány xx&xxxx;xxxxxxxx xxxxxx xx xxxx uvedeného zveřejnění. |
Xxxxxx 22
Xxxxxxxx použití
1. Xxxx xx xxxxxx xx. 55 xxxx. 1 xxxxxxxx (EU) x. 528/2012, xx xxxxxxxx měsíců xx xxxx xxxxxxxxxx o neschválení xxxxxxxxx xxxxxx xxxxx, xxxxx xxxxxxx xxxx xxxxxxxx xxxx xxxxxxxxx xxxxxxx xxxxx xx xxxxxxxxx x xxxxxx uvedených x xx. 5 xxxx. 2 xxxxxx xxxxxxxxxxx xxxx. b) xxxx x) xxxxxxxx (EU) x. 528/2012, xxxxx členský xxxx xxxx xxxxxxxxx Xxxxxx odůvodněnou žádost x xxxxxxxx xx xx. 89 xxxx. 2 xxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx xxxxxxx xxxx xxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxx prostřednictvím xxxxxxxxx. Xxxxx xxxxxx xxxxxxxx xxxxxxx xxxxxxxxx, xxxxxxxx xxxxxxx xxxx musí xxxxxxx xxxxxxxxx nedůvěrné xxxxx.
3. Xxxxxxxx xxxxxxxx xxxxxx xxxx xxxxxxxx xxxxxxxxxx xxxxx xxxxxxxxxxxxxx xxxxxxxxxx. Xxxxxxx xxxxx nebo xxxx xxxxx mohou xxxxx xxxxxxxxxx xx xxxxx 60 xxx xx xxxxxxxxxx.
4. Xx xxxxxxx xxxxxxxxxx xxxxxxxxxx xxxx Xxxxxx xxxxxxx xxxxxxxx xx xx. 89 xxxx. 2 xxxxxxx xxxxxxxxxxx xxxxxxxx (EU) x. 528/2012, xxxxx xxxxxx uvádět xxxxxxxx xxxxxxxxx, xxx xxxxxxxxx z xxxx xxxxx, xxxxxxxx ji xxxx x ní xxxxxxxx, xx xxx xxxxxxxxxx členského xxxxx x xxxxxxxx je x xxxxx xxxxxxxx xxxxx v souladu x xxxxxxxxxxxxxx právními xxxxxxxx x x xxxxxxxx xxxxxxxx xxxxxxxx 5 x xxxxxxxxx xxxxxxx xxxxxxxx xxxxxxxxx Xxxxxx.
5. Xxxxxxx xxxx, jemuž xx xxxxxxxx xxxxxxxx:
x) |
xxxxxxx, že další xxxxxxxxx xxxx xxxxxxx xx xxxxxx xxxxxxx x xxxxxxx xxxx, xxx xxxx plněny podmínky xxxxxxxx 1; |
x) |
xxxxxx xxxxxx xxxxxxxx xx xxxxxxxx rizik, xxx xxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxxxx, xxxxxx xxxx xxxxxxxxx xxxxxxxxx; |
c) |
zajistí, xxx xx xxxxxxx xxxxxxxxxxxx xxxxxx nebo xxx xxxx xxxx xxxx xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxx x xxxxxxxxx xxxxxx xxxxx v souladu xxxxxxx 7 nařízení (XX) x. 528/2012. |
XXXXXXXX 5
XXXXXXXXX XXXXXXXXXX
Xxxxxx 23
Xxxxxxx
Xxxxxxx xx xxxxxxxx (XX) č. 1451/2007.
Xxxxxx xx xxxxxxx xxxxxxxx xx považují xx xxxxxx xx xxxx xxxxxxxx.
Xxxxxx 24
Xxxxx v xxxxxxxx
Xxxx xxxxxxxx xxxxxxxx x xxxxxxxx dvacátým xxxx xx vyhlášení x Xxxxxxx xxxxxxxx Xxxxxxxx xxxx.
Xxxx xxxxxxxx xx xxxxxxx x xxxxx xxxxxxx x xxxxx xxxxxxxxxx ve všech xxxxxxxxx státech.
X Bruselu xxx 4. xxxxx 2014.
Xx Xxxxxx
xxxxxxxx
José Xxxxxx XXXXXXX
(1)&xxxx;&xxxx;Xx. věst. X 167, 27.6.2012, x. 1.
(2)&xxxx;&xxxx;Xxxxxxxx Xxxxxx (XX) x. 1451/2007 xx xxx 4. xxxxxxxx 2007 x druhé xxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxx x xx. 16 xxxx. 2 xxxxxxxx Evropského xxxxxxxxxx x Xxxx 98/8/XX o uvádění xxxxxxxxxx xxxxxxxxx xx xxx (Úř. věst. X 325, 11.12.2007, x. 3).
(3) Směrnice Xxxxxxxxxx xxxxxxxxxx x Xxxx 98/8/XX xx dne 16. xxxxx 1998 o xxxxxxx xxxxxxxxxx přípravků xx trh (Úř. xxxx. X 123, 24.4.1998, x. 1).
(4) Rozsudek Xxxxxxxx dvora (xxxxxxx xxxxxx) xx xxx 1. xxxxxx 2012 (xxxxxx o xxxxxxxxxx o předběžné xxxxxx: Xxxxxxxxxxx Xxxxxxx – Xxxxxxx) – Xöxx GmbH xxxxx Xxxxx GmbH (uvádění xxxxxxxxxx přípravků xx xxx – směrnice 98/8/XX – čl. 2 xxxx. 1 xxxx. x) – xxxxx „xxxxxxxx xxxxxxxxx“ – xxxxxxxxx, xxxxx xxxxxxxxx vločkování xxxxxxxxxx xxxxxxxxx, xxxx je xxxx, odpuzuje xxxx xxxxxxxxxxx), C-420/10.
(5)&xxxx;&xxxx;Xxxxxxxxx nařízení Xxxxxx (XX) x.&xxxx;88/2014 ze xxx 31.&xxxx;xxxxx 2014, xxxxxx xx stanoví xxxxxx xxx xxxxx xxxxxxx X&xxxx;xxxxxxxx Xxxxxxxxxx xxxxxxxxxx a Rady (XX) x.&xxxx;528/2012 o dodávání xxxxxxxxxx xxxxxxxxx xx trh x&xxxx;xxxxxx xxxxxxxxx (Xx. xxxx. X 32, 1.2.2014, x. 3).
(6)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx parlamentu x Rady (ES) x. 1272/2008 xx xxx 16. xxxxxxxx 2008 x xxxxxxxxxxx, xxxxxxxxxx x xxxxxx xxxxx x směsí, x změně x xxxxxxx xxxxxxx 67/548/XXX x 1999/45/ES a x xxxxx xxxxxxxx (XX) x. 1907/2006 (Xx. věst. L 353, 31.12.2008, s. 1).
(7) Prováděcí nařízení Xxxxxx (XX) x.&xxxx;564/2013 ze xxx 18.&xxxx;xxxxxx 2013 x&xxxx;xxxxxxxxxx x&xxxx;xxxxxxxx xxxxxxxxx Xxxxxxxx xxxxxxxx xxx xxxxxxxx xxxxx podle xxxxxxxx Evropského xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;528/2012 x&xxxx;xxxxxxxx biocidních xxxxxxxxx xx xxx x&xxxx;xxxxxx xxxxxxxxx (Xx.&xxxx;xxxx.&xxxx;X 167, 19.6.2013, x. 17).
(8)&xxxx;&xxxx;Xxxxxxxx Evropského xxxxxxxxxx x Xxxx (XX) x. 1907/2006 ze xxx 18. prosince 2006 x registraci, xxxxxxxxx, xxxxxxxxxx x xxxxxxxxx chemických xxxxx, x zřízení Xxxxxxxx xxxxxxxx xxx xxxxxxxx xxxxx, x změně xxxxxxxx 1999/45/ES a x xxxxxxx nařízení Xxxx (XXX) x.&xxxx;793/93, xxxxxxxx Xxxxxx (ES) x. 1488/94, xxxxxxxx Xxxx 76/769/XXX x xxxxxxx Xxxxxx 91/155/XXX, 93/67/XXX, 93/105/XX x 2000/21/XX (Xx. xxxx. X 396, 30.12.2006, x. 1).
XXXXXXX X
Informace xxxxxxxxxx xxx oznámení xxxxx xxxxxx 17
Oznámení xxxxx xxxxxx 17 xxxxxxxx xxxx xxxxxxxxx:
1) |
důkaz, xx xxxxx xx stávající xxxxxxx xxxxxx xx xxxxxx čl. 3 xxxx. 1 xxxx. x) xxxxxxxx (XX) č. 528/2012; |
2) |
údaje x xxxx/xxxxxx xxxxxxxxx, na xxxxx/x se oznámení xxxxxxxx; |
3) |
xxxxxxxxx x xxxxx studiích, xxxxx xxxx xxxxxx xxx xxxxx xxxxxxx x xxxxxxxxx xx xxxxxxxx xx xxxxxxx X xxxxxxxx (EU) x. 528/2012, jakož x xxxxxxxxx xxxxx jejich xxxxxxxxx; |
4) |
xxxxxxxxx xxxxxxx x xxxxxxxx
|
5) |
xxxxx xxxx toto xxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 xxxx. x), xxxxx, že látka xxxx xx xxxx xxxx xxxxxx xxxxx xxxxxxxxxx přípravku xxxxxxxxxxx do příslušného typu xxxxxxxxx v den oznámení xxxx zveřejnění xxxxxxxxxx xxxx xxxxxx xxxxxxxxx xx xxxxxxxx xxxxxxx. |
XXXXXXX XX
XXXXXXXXX XXXXX X XXXX PŘÍPRAVKU XXXXXXXX XX XXXXXXXX XXXXXXXX DNE 4. XXXXX 2014
XXXX 1
Xxxxxxxxx účinné xxxxx x xxxx xxxxxxxxx podporované xx xxx 4. xxxxx 2014, x xxxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxxxxxx xxx těch, xxxxx xxxx výslovně xxxxxxx x xxxxxxxxx 1017 a 1019.
Xxxxx xxxxxxx |
Xxxxx látky |
Členský xxxx xxxxxxxxx |
Xxxxx ES |
Xxxxx CAS |
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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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200-578-6 |
64-17-5 |
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200-579-1 |
64-18-6 |
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xxxxxx-2-xx |
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200-661-7 |
67-63-0 |
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200-712-3 |
69-72-7 |
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200-746-9 |
71-23-8 |
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200-849-9 |
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201-069-1 |
77-92-9 |
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xxxxxxxxx kyselina/2-hydroxyethanová 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 kyselina |
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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) |
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201-501-9 |
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201-993-5 |
90-43-7 |
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203-213-9 |
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203-377-1 |
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204-589-7 |
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179 |
xxxx xxxxxxxx |
XX |
204-696-9 |
124-38-9 |
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x |
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180 |
(xxxxxxx-xxxxxxxxx) – xxxxxxx-xxxxxxxxxxxxxxx |
XX |
204-708-2 |
124-65-2 |
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x |
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185 |
tosylchloramid, xxxxx xxx (xxxxx xxx xxxxxxxxxxxxxxx – xxxxxxxxx X) – (X-xxxxx-4-xxxxxxxxxxxx-1-xxxxxxxxxx |
XX |
204-854-7 |
127-65-1 |
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x |
x |
x |
x |
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187 |
xxxxxx-xxxxxxxxxxxxxxxxxxxxxx |
XX |
204-875-1 |
128-03-0 |
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x |
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x |
x |
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188 |
xxxxxxx-xxxxxxxxxxxxxxxxxxxxxx |
XX |
204-876-7 |
128-04-1 |
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x |
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x |
x |
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195 |
xxxxxxx-xxxxxxx-2-xxxx |
XX |
205-055-6 |
132-27-4 |
x |
x |
x |
x |
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x |
x |
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x |
x |
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x |
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198 |
X-[(xxxxxxxxxxxxxx)xxxxxxxx]xxxxxxxx (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 |
diuron |
XX |
206-354-4 |
330-54-1 |
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x |
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x |
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239 |
xxxxxxxxxxxxx |
XX |
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) |
BE |
208-576-7 |
533-74-4 |
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x |
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x |
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279 |
X-[(xxxxxxxxxxxxxxxxxx)xxxxxxxx]-X′,X′-xxxxxxxx-X-(4-xxxxxxxxxxx)xxxxxxxxxx (xxxxxxxxxxxx) |
XX |
211-986-9 |
731-27-1 |
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x |
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283 |
xxxxxxxxx |
XX |
212-950-5 |
886-50-0 |
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x |
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x |
x |
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288 |
X-[(xxxxxxxxxxxxxxxxxx)xxxxxxxx]-X-xxxxx-X′,X′-xxxxxxxxxxxxxxxx (dichlofluanid) |
UK |
214-118-7 |
1085-98-9 |
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x |
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x |
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289 |
thiokyanatan měďný |
XX |
214-183-1 |
1111-67-7 |
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x |
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292 |
[(1,3-xxxxx-1,3,4,5,6,7-xxxxxxxxx-2X-xxxxxxxx-2-xx)xxxxxx]-xxxxx-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxx-xxxxxxxxxxxx) |
XX |
214-619-0 |
1166-46-7 |
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x |
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958 |
xxxxxxxx xxxxxxxx/xxxxxxxxxxx xxxxx/xxxxxx xxxxx |
XX |
215-137-3 |
1305-62-0 |
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x |
x |
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959 |
xxxx vápenatý/vápno/pálené vápno/nehašené xxxxx |
XX |
215-138-9 |
1305-78-8 |
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x |
x |
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306 |
xxxx měďný |
FR |
215-270-7 |
1317-39-1 |
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x |
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315 |
xxxxx-2-xx-xxxxxxx |
XX |
215-661-2 |
1338-23-4 |
x |
x |
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321 |
xxxxxxxxxxx |
UK |
217-129-5 |
1746-81-2 |
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x |
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330 |
N-(3-aminopropyl)-N-dodecylpropan-1,3-diamin (diamin) |
XX |
219-145-8 |
2372-82-9 |
|
x |
x |
x |
|
x |
|
x |
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x |
x |
x |
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336 |
X,X′-xxxxxxxx-2,2′-xxxxxxxxxxxxxxxxxxxxxx (XXXXX) |
XX |
219-768-5 |
2527-58-4 |
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x |
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339 |
1,2-xxxxxxxxxxxxxxx-3(2X)-xx (XXX) |
XX |
220-120-9 |
2634-33-5 |
|
x |
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x |
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x |
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x |
x |
x |
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341 |
2-xxxxxxxxxxxxxxxxxxxxxxxxxx-3(2X)-xx (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 (MES) |
XX |
221-106-5 |
3006-10-8 |
x |
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354 |
xxxxxxxxx |
DK |
222-182-2 |
3380-34-5 |
x |
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359 |
(xxxxxxxxxxxx)xxxxxxxxxx (reakční xxxxxxxx xxxxxxxxxxxxxx x xxxxxxxxxxxxxxxx (EGForm)) |
XX |
222-720-6 |
3586-55-8 |
|
x |
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x |
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x |
x |
x |
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365 |
pyridin-2-thiol-1-oxid, sodná xxx (pyrithion xxxxx) |
SE |
223-296-5 |
3811-73-2 |
|
x |
x |
|
|
x |
x |
|
x |
x |
|
|
x |
|
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|
368 |
1-(3-chlorallyl)-3,5,7-triaza-1-azoniaadamantan-chlorid (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) |
PL |
225-208-0 |
4719-04-4 |
|
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x |
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x |
x |
x |
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382 |
1,3,4,6-xxxxxxxx(xxxxxxxxxxxxx)xxxxxxxxxxxxxxxx[4,5-x]xxxxxxxx-2,5-xxxx (XXXX) |
ES |
226-408-0 |
5395-50-6 |
|
x |
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x |
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x |
x |
x |
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387 |
dimorfolinomethan (XXX) |
XX |
227-062-3 |
5625-90-1 |
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x |
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x |
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392 |
xxxxxxxx-xxxxxxxxxxxx |
XX |
228-652-3 |
6317-18-6 |
|
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x |
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393 |
1,3-xxx(xxxxxxxxxxxxx)-5,5-xxxxxxxxxxxxxxxxxxxx-2,4-xxxx (DMDMH) |
XX |
229-222-8 |
6440-58-0 |
|
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x |
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x |
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397 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxxx (XXXX) |
IT |
230-525-2 |
7173-51-5 |
x |
x |
x |
x |
|
x |
|
x |
|
x |
x |
x |
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401 |
xxxxxxx |
SE |
231-131-3 |
7440-22-4 |
|
x |
|
x |
x |
|
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x |
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403 |
měď |
XX |
231-159-6 |
7440-50-8 |
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x |
|
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 |
chlornan xxxxx |
IT |
231-668-3 |
7681-52-9 |
x |
x |
x |
x |
x |
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x |
x |
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434 |
xxxxxxxxxxxx |
DE |
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) |
PL |
231-810-4 |
7747-35-5 |
|
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x |
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x |
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450 |
dusičnan stříbrný |
XX |
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 |
xxxxx |
XX |
231-959-5 |
7782-50-5 |
|
x |
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x |
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x |
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458 |
xxxxx xxxxxx |
XX |
231-984-1 |
7783-20-2 |
|
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x |
x |
|
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473 |
xxxxxxxxxx x xxxxxxxxxxx |
XX |
232-319-8 |
8003-34-7 |
|
|
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x |
x |
|
|
491 |
xxxx xxxxxxxxxx |
XX |
233-162-8 |
10049-04-4 |
|
x |
x |
x |
x |
|
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x |
x |
|
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|
494 |
2,2-xxxxxx-2-xxxxxxxxxxxx (XXXXX) |
XX |
233-539-7 |
10222-01-2 |
|
x |
|
x |
|
x |
|
|
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x |
x |
x |
|
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|
501 |
xxxxxxxxxxx |
XX |
234-232-0 |
10605-21-7 |
|
|
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|
x |
|
x |
x |
|
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|
515 |
xxxxxx amonný |
XX |
235-183-8 |
12124-97-9 |
|
|
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|
x |
x |
|
|
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|
522 |
xxxx-1-xxx-1λ5-xxxxxxx-2-xxxxxxx |
SE |
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 |
ES |
237-243-9 |
13707-65-8 |
|
|
|
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|
x |
|
|
x |
x |
|
|
x |
|
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529 |
xxxxxxxxxxxxxxx |
XX |
237-601-4 |
13863-41-7 |
|
|
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x |
|
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|
531 |
(xxxxxxxxx)xxxxxxxx |
XX |
238-588-8 |
14548-60-8 |
|
|
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|
x |
|
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x |
|
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|
534 |
bis(1-hydroxypyridin-2(1H)-thionato-O,S)měďnatý xxxxxxx (xxxxxxxxx xxxx) |
XX |
238-984-0 |
14915-37-8 |
|
|
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|
x |
|
541 |
xxxxxxx-4-xxxxx-3-xxxxxxxxxxxxx |
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) (CHDG) |
XX |
242-354-0 |
18472-51-0 |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
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|
554 |
4-[(xxxxxxxxxxx)xxxxxxxx]-1-xxxxxxxxxxxx |
XX |
243-468-3 |
20018-09-1 |
|
|
|
|
|
x |
x |
|
x |
x |
|
|
|
|
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|
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 (prallethrin) |
EL |
245-387-9 |
23031-36-9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
563 |
kalium-(E,E)-hexa-2,4-dienoát (sorbát xxxxxxxx) |
XX |
246-376-1 |
24634-61-5 |
|
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
|
566 |
α, α′,α′′-xxxxxxxxxxxxxxxxxx-1,3,5-xxxxxxx-1,3,5-xxxxxxxxxx (XXX) |
AT |
246-764-0 |
25254-50-6 |
|
x |
|
|
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
571 |
2-xxxxxxxxxxxxxxxxxxxxxxxxx-3-xx (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 (BCDMH/bromchlordimethylhydantoin) |
XX |
251-171-5 |
32718-18-6 |
|
x |
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
590 |
3-(4-isopropylfenyl)-1,1-dimethylmočovina/isoproturon |
XX |
251-835-4 |
34123-59-6 |
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
|
|
|
|
597 |
1-[2-(allyloxy)-2-(2,4-dichlorfenyl)ethyl]imidazol (xxxxxxxx) |
XX |
252-615-0 |
35554-44-0 |
|
|
x |
|
|
|
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|
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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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
600 |
2-xxxx-2-(xxxxxxxxxx)xxxxxxxxxxxxxx (XXXXX) |
CZ |
252-681-0 |
35691-65-7 |
|
|
|
|
|
x |
|
|
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|
961 |
xxxx xxxxxxxx-xxxxxxxxx/xxxxxxxxxxx xxxxx |
XX |
253-425-0 |
37247-91-9 |
|
x |
x |
|
|
|
|
|
|
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|
|
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|
|
|
|
962 |
xxxxxxxx xxxxxxxx-xxxxxxxxx/xxxxxxxxxxx xxxxxxxxxxx xxxxx |
XX |
254-454-1 |
39445-23-3 |
|
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 |
xxxxxxxx(xxxxxxxxxx)[3-(xxxxxxxxxxxxxxx)xxxxxx]xxxxxxx-xxxxxxx |
XX |
255-451-8 |
41591-87-1 |
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x |
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609 |
cis- a xxxxx-x-xxxxxxx-3,8-xxxx (směs) (xxxxxxxxxx) |
XX |
255-953-7 |
42822-86-6 |
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x |
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614 |
(XX)-α-xxxxx-3-xxxxxxxxxxxx-(1XX)-xxx,xxxxx-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
257-842-9 |
52315-07-8 |
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x |
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615 |
3-xxxxxxxxxxxx(1XX,3XX;1XX,3XX)-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (xxxxxxxxxx) |
XX |
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 (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) (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-dichlorfenyl)-4-propyl- 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 (ATMAC/TMAC) |
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-xxxxxxx- 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-xxxxxxxxxxx)-3-[(xxxxxxxxxxxxxxx)xxxxx]xxxxxxxx (triflumuron) |
IT |
264-980-3 |
64628-44-0 |
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x |
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656 |
bis(5-methyloxazolidin-3-yl)methan (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-fenoxy-4-fluorfenyl)kyanmethyl]-3-(2,2-dichlorvinyl)-2,2-dimethylcyklopropan-1-karboxylát (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 |
xxxxx(X12-16)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXX/XXX (X12-X16)) |
XX |
270-325-2 |
68424-85-1 |
x |
x |
x |
x |
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x |
x |
x |
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x |
673 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxxx (DDAC) (X8-10) |
XX |
270-331-5 |
68424-95-3 |
x |
x |
x |
x |
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x |
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x |
x |
x |
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690 |
xxxxx(X12-X18)xxxxxx(xxxxxxxx)xxxxxxxx xxxx 1,1-dioxo-1λ-1,2-benzoisothiazol-3(2H)-onu (ADBAS) |
XX |
273-545-7 |
68989-01-5 |
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x |
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x |
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691 |
natrium-N-(hydroxymethyl)glycinát |
AT |
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) |
PL |
279-013-0 |
84665-66-7 |
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x |
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1015 |
xxxxxxx, Xxxxxxxxxxx indica, 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)) |
XX |
287-089-1 |
85409-22-9 |
x |
x |
x |
x |
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x |
x |
x |
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x |
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 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 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 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 |
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x |
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792 |
xxxxxxx xxxxxxxxxxxxxxxxxxx (XXXX) |
XX |
420-970-2 |
92047-76-2 |
x |
x |
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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 |
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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-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx- 1-karboxylát (xxxx xxxxxxxxxxxxx) (xxxxxxxxxxx) |
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 (xxxxxxxxxxxxx) |
DE |
433-460-1 |
210880-92-5 |
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x |
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952 |
Xxxxxxxx xxxxxxxxxx 2362, kmen ABTS-1743 |
XX |
xxxxxxxxxxxxxxx |
143447-72-7 |
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x |
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955 |
Xxxxxxxx xxxxxxxxxxxxx subsp. xxxxxxxxxxx, xxxx SA3A |
XX |
mikroorganismus |
xxxx relevantní |
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x |
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957 |
Xxxxxxxx xxxxxxxx |
XX |
xxxxxxxxxxxxxxx |
xxxx relevantní |
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x |
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928 |
5-chlor-2-methylisothiazol-3(2H)-on (Einecs 247-500-7) a 2-xxxxxxxxxxxxxxxx-3(2X)-xx (Xxxxxx 220-239-6), směs (3:1) (xxxx CMIT/MIT) |
XX |
směs |
55965-84-9 |
|
x |
|
x |
|
x |
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x |
x |
x |
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939 |
aktivní xxxxx (xxxxxxxx xxxxxx xxxxxxxx chlorné x xxxxxxxxx xxxxxxx xx xxxx) |
XX |
xxxx |
xxxx xxxxxxxxxx |
|
x |
x |
x |
x |
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813 |
xxxxxxxxxxxxxx xxxxxxxx |
XX |
xxxx xxxxxxxxxx |
33734-57-5 |
|
x |
x |
x |
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1014 |
xxxxxxxx xxxxxx |
XX |
není 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) |
XX |
xxxx xxxxxxxxxx |
188023-86-1 |
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x |
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|
931 |
alkyltrimethylendiaminy, X-X12-14(xx xxxxx xxxxxx), xxxxxxxx xxxxxx x xxxxxxxxxxxx xxxxxxxxx (Ampholyt 20) |
XX |
xxxx xxxxxxxxxx |
139734-65-9 |
|
x |
x |
x |
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152 |
xxxxxxxx xxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-xxxxx-5-xxxxxxxxxxxxxxxx x xxxxxx a 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 x xxxxxxxxx |
x |
x |
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x |
x |
|
x |
x |
x |
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777 |
xxxxxxx produkty 5,5-xxxxxxxxxxxxxxxxxx, 5-xxxxx-5-xxxxxxxxxxxxxxxx x xxxxxxx (XXXXX) |
XX |
xxxx x xxxxxxxxx |
xxxx x xxxxxxxxx |
|
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x |
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810 |
xxxxxxxxxxxxxx xxxx x obsahem xxxxxxx |
XX |
xxxx x xxxxxxxxx |
308069-39-8 |
|
x |
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x |
|
x |
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|
824 |
xxxxxxxx-xxxxxxxxx xxxxxx |
XX |
není x xxxxxxxxx |
130328-20-0 |
|
x |
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x |
x |
|
x |
|
x |
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|
1013 |
xxxxxxxx-xxxxxxx zeolit |
XX |
xxxx k dispozici |
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 |
stříbro xxxxxxxxxxx na xxxxx xxxxxxxxxx (xxxx xxxxxxxxxxxx xx xxxxx xxxxxxxxxx xxxxxxxx x primárními xxxxxxxxx xx xxxxxxxxxx) |
XX |
xxxx x xxxxxxxxx |
xxxx x xxxxxxxxx |
|
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x |
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1019 |
xxxx xxxxxxxxx (xxxx xxxxxxxxxxxx tvořený agregáty 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 |
(RS)-3-alyl-2-metyl-4-oxocyklopent-2-enyl-(1R,3R;1R,3S)-2,2-dimetyl-3-(2-metylprop-1-enyl)-cyklopropankarboxylát (směs 4 xxxxxxx 1R xxxxx, 1X: 1X xxxxx, 1S: 1R xxx, 1R: 1R xxx, 1X 4:4:1:1) (x-xxxxxxxxx) |
XX |
xxxxxxxxx xx ochranu 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 |
přípravek xx xxxxxxx xxxxxxx |
260359-57-7 |
|
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|
|
|
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|
x |
|
|
|
848 |
N-[(6-chlor-3-pyridyl)methyl]-N′-kyan-N-methylethanimidamid (acetamiprid) |
XX |
přípravek xx ochranu xxxxxxx |
160430-64-8 |
|
|
|
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x |
|
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|
835 |
xxxxxxxxxxxx/(X)-(3-xxxxxxxxxxx)xxxxxxxxxx-(X)-2-(4-xxxxxxxxxx)-3-xxxxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
xxxxxxxxx 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-xxxxxxxxxxxx) |
XX |
přípravek na 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 |
přípravek xx xxxxxxx xxxxxxx |
122453-73-0 |
|
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x |
|
|
|
859 |
polymer X-xxxxxxxxxxxxxxxxx(XXXXXX 204-697-4) x (xxxxxxxxxxx)xxxxxxxx (XXXXXX 203-439-8)/xxxxxxxxx xxxxxxxxx chlorid amonný (XX Xxxxxxx) |
XX |
xxxxxxx |
25988-97-0 |
|
x |
|
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x |
|
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|
863 |
poly(biguanid-1,5-diylhexan-1,6-diyl) (XXXX) |
XX |
polymer |
27083-27-8/32289-58-0 |
x |
x |
x |
x |
x |
x |
|
|
x |
|
x |
|
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|
868 |
poly(biguanid-1,5-diylhexan-1,6-diyl-hydrochlorid) |
XX |
xxxxxxx |
91403-50-8 |
x |
x |
x |
x |
|
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x |
|
x |
|
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|
869 |
α-[2-(xxxxxxxxxxxxxxxxxxx)xxxxx]-ω-[xxxxxxxxxxx(xxxxxxxxxx)-xxxxxxxxx] (Xxxxxx 26) |
XX |
xxxxxxx |
94667-33-1 |
|
x |
|
x |
|
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x |
|
x |
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|
872 |
N-didecyl-N-dipolyethoxyammonium-borát/ 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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ČÁST 2
Xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx nepodporované xx xxx 4. xxxxx 2014
Xxxx část xxxx přílohy xxxxxxxx
— |
xxxxxxxxx xxxxx x xxxx přípravku xxxxxxx v tabulce xxxx, xxxxxx xxxxxxxxxx xxxxxxxxx, |
— |
jakékoli xxxxxxxxx xxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx x xxxxxxx x xxxxx 1, xxxxx xxxx, xxxxx xxxx xxxxxxx x xxxxxxx, x |
— |
xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx účinných xxxxx x xxxx xxxxxxxxx schválených xx 4. xxxxx 2014, x xxxxxxxx xxxx, které xxxx výslovně xxxxxxxxx. |
Kombinace xxxxx a typu přípravku x xxxxxxxxxxxxx xxxxxxxx xx xxxx části xxxxx předmětem xxxxxxxxxx x xxxxxxxxxxx xxxxx xxxxxx 20, xxxxxxxx xxxxx osoba xxxxxx xxxxxxxx xx xxxxxxxx xxxxxx xx vstupu xxxxxx xxxxxxxx x xxxxxxxx xxxxx xx. 14 odst. 3 xxxx xxxxx xx xxxxxx xxxxxxxx xxxxxxxxx podle xx. 17 xxxx. 4 nebo 5.
Xxxxx xxxxxxx |
Xxxxx xxxxx |
Xxxxxxx xxxx xxxxxxxxx |
Číslo XX |
Číslo XXX |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
17 |
18 |
19 |
21 |
22 |
1021 |
1,3-xxxxxxx-5,5-xxxxxxxxxxxxxxxxx (nově definovaný xxxxx položky 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 |
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 položka 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 xxxxxxx 949) |
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219-234-1 |
2390-68-3 |
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384 |
xxxxxxxx(xxxxxxx)xxxxxxx-xxxxxxx (xxx xxxxxxx 949) |
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226-901-0 |
5538-94-3 |
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399 |
xxxxxx(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxx (xxx xxxxxxx 948) |
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230-698-4 |
7281-04-1 |
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401 |
xxxxxxx |
XX |
231-131-3 |
7440-22-4 |
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x |
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418 |
xxxx xxxxxxxxx xxxxxxx |
FR |
231-545-4 |
7631-86-9 |
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x |
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449 |
xxxxx xxxxxxx |
XX |
231-847-6 |
7758-98-7 |
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x |
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1016 |
xxxxxxx xxxxxxxx |
XX |
232-033-3 |
7783-90-6 |
x |
x |
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x |
x |
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x |
x |
x |
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554 |
4-[(dijodmethyl)sulfonyl]-1-methylbenzen |
XX |
243-468-3 |
20018-09-1 |
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x |
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587 |
xxxxx(xxxxxxxx)xxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 949) |
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251-035-5 |
32426-11-2 |
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601 |
xxxxxxxxxxxxxx(xxxxxxx-9-xx-1-xx)xxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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253-363-4 |
37139-99-4 |
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615 |
3-fenoxybenzyl(1RS,3RS;1RS,3SR)-3-(2,2-dichlorvinyl)-2,2-dimethylcyklopropankarboxylát (xxxxxxxxxx) |
XX |
258-067-9 |
52645-53-1 |
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x |
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637 |
alkyl(benzyl)dimethylamonium-chloridy (xxxxx xxxxxxx xx xxxxxxxx kyselin xxxxxxxxxx xxxxx) (viz xxxxxxx 948) |
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263-080-8 |
61789-71-7 |
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638 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (alkyl odvozen xx mastných kyselin xxxxxxxxxx xxxxx) (viz xxxxxxx 949) |
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263-087-6 |
61789-77-3 |
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639 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxxx xxxxxxx xx xxxxxxxxxxxxxxx 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 |
dialkyl(C6-C12)dimethylamonium-chloridy (xxx položka 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 |
xxxxx(X10-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxx xxxxxxx 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 x xxxxx xxxxxxxx Xxxxxxxxxxx xxxxxx 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 xxxxxxx 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 položky 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 xxxxxxx xxxxxxxx-xxxxxxx, xxxxxxxx-xxxxxxxxx x xxxxxxxx-xxxxxxxxx x xxxxxxxxx vodíku (xxxxxxxx) |
XX |
432-790-1 |
xxxx xxxxxxxxxx |
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x |
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923 |
xxxxx(xxxxxx)xxxxxxxxxxxxxxx-xxxxxxx/xxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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směs |
8001-54-5 |
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949 |
(dialkyl)dimethylamonium-chloridy, -xxxxxxx xxxx -methyl-sulfáty) (xxxxxx (X6-X18) xxxxxxxx x xxxxxxxxxx, odvozené xx xxxxxxxx xxxxxxx loje, xxxxxxxxxx xxxxx x xxxxxxxx xxxxx) (XXXX) |
IT |
xxxx xxxxx xxxxxxxxx v xxxxxxx XXXXXX |
není xxxxxxxxxx |
x |
x |
x |
x |
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x |
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x |
x |
x |
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950 |
alkyltrimethylamonium-chloridy, -xxxxxxx xxxx -xxxxxx-xxxxxxx) (xxxxxx (X8-X18) xxxxxxxx x nenasycené, xxxxxxxx xx xxxxxxxx xxxxxxx xxxx, xxxxxxxxxx oleje x sójového xxxxx) (XXXX) |
XX |
xxxx látek xxxxxxxxx x xxxxxxx XXXXXX |
není xxxxxxxxxx |
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x |
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948 |
xxxxxx(xxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -bromidy nebo -xxxxxxxxx) (alkyly (X8-X22) xxxxxxxx x xxxxxxxxxx, xxxxxxxx xx mastných xxxxxxx xxxx, xxxxxxxxxx xxxxx x xxxxxxxx xxxxx) (XXX) |
XX |
xxxx xxxxx uvedených x xxxxxxx XXXXXX |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
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x |
x |
x |
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849 |
3-xxxxxxxxxxxx-(1X,3XX)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxxxxxx) |
XX |
xxxx xxxxxxxxxx |
188023-86-1 |
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x |
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1001 |
alkyl(C12-C16)benzyl(dimethyl)amonium-chloridy (xxxx než látka xxxxxxxxx pod xxxxxxx 671) |
XX |
xxxx xxxxxxxxxx |
není relevantní |
x |
x |
x |
x |
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x |
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x |
x |
x |
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x |
1002 |
alkyl(C12-C18)benzyl(dimethyl)amonium-chloridy(jiné xxx látka xxxxxxxxx xxx xxxxxxx 667) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
x |
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x |
1003 |
alkyl(C12-C18)(ethylbenzyl)dimethylamonium- xxxxxxxx (xxxx než xxxxx xxxxxxxxx xxx xxxxxxx 725) |
XX |
xxxx xxxxxxxxxx |
není xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
x |
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x |
1005 |
alkyl(C12-C14)benzyl(dimethyl)amonium-chloridy (xxxx xxx látka xxxxxxxxx xxx položku 724) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
x |
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x |
1006 |
xxxxxxxxxxxxxx xxxx obsahující xxxxxxx, xxxxx, hliník x xxx |
XX |
xxxx xxxxxxxxxx |
398477-47-9 |
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x |
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x |
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x |
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1009 |
xxxxxxx(X8-X10)xxxxxxxxxxxxxx-xxxxxxxx (xxxx xxx látka xxxxxxxxx xxx xxxxxxx 673) |
XX |
xxxx xxxxxxxxxx |
xxxx relevantní |
x |
x |
x |
x |
x |
x |
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x |
x |
x |
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1011 |
xxxxx(xxxxxxxxx)xxxxxxx-xxxxxxxx (alkyl xxxxxxx xx mastných xxxxxxx xxxxxxxxxx xxxxx) (xxxx xxx xxxxx xxxxxxxxx xxx xxxxxxx 635) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
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x |
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1012 |
xxxxxxxxxxxxxxxxx xxxxx, xxxxxxxx x xxxxxxxxx xxxxxxx/xxxxxxxx-xxxxxxxxx xxxxxx |
SE |
není xxxxxxxxxx |
130328-20-0 |
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x |
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x |
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x |
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598 |
(±)-1-(β-xxxxxxxx-2,4-xxxxxxxxxxxxxxxxx)xxxxxxxx (imazalil xxxxxxxxx) |
DE |
přípravek xx xxxxxxx rostlin |
73790-28-0 |
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x |
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XXXXXXX XXX
Xxxxx
Xxxx xxxxxxxxx |
Lhůty xxx xxxxxxxxxx xxxxxxxxx zprávy xxxxx čl. 6 xxxx. 3 xxxx. x) |
Xxxxx pro xxxxxxxx xxxxxxxx stanoviska xxxxx xx. 7 xxxx. 2 xxxx. x) |
8, 14, 16, 18, 19 x 21 |
31.12.2015 |
31.3.2016 |
3, 4 x 5 |
31.12.2016 |
31.3.2017 |
1 x 2 |
31.12.2018 |
31.3.2019 |
6 x 13 |
31.12.2019 |
31.3.2020 |
7, 9 x 10 |
31.12.2020 |
31.3.2021 |
11, 12, 15, 17, 20 x 22 |
31.12.2022 |
31.9.2023 |