XXXXXXXX XXXXXX X XXXXXXXXX XXXXXXXXX (XX) č. 1062/2014
xx xxx 4. xxxxx 2014,
xxxxxxxx se xxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx všech 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,
x xxxxxxx xx Xxxxxxx x xxxxxxxxx Xxxxxxxx xxxx,
x xxxxxxx xx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 528/2012 xx xxx 22. května 2012 x xxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxx x xxxxxx xxxxxxxxx (1), x zejména xx xx. 89 xxxx. 1 xxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx,
vzhledem x těmto xxxxxxx:
(1) |
Nařízení Xxxxxx (ES) č. 1451/2007 (2) xxxxxxx prováděcí pravidla xxx xxxxxxx přezkumu xxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx (xxxx xxx „xxxxxxx xxxxxxxx“), xxxxx xxx zahájen x xxxxxxx x xx. 16 xxxx. 2 xxxxxxxx Xxxxxxxxxx parlamentu x Xxxx 98/8/XX (3). Xxxxxxx tato xxxxxxxx xxxx xxxxxxx x xxxxxxxxx xxxxxxxxx (XX) x. 528/2012, xxxx by xxx prováděcí xxxxxxxx xxx pokračování xxxxxxxx xxxxxxxx xxxxxxxxxxxx ustanovením xxxxxxxxx xxxxxxxx. |
(2) |
Je xxxxxxxx xxxxx xxxxxxxxx účinné xxxxx x xxxx xxxxxxxxx, které xxxxx xxx dodávány xx xxx x xxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxxxx xxxxxx 89 nařízení (XX) x. 528/2012 x xxxxxxxx xxxxxxxxxxxxxx předpisů. Xxxx xx xxxx xxx x x případě xxxxxxxxx xxxxxx látky x typu xxxxxxxxx, xxxxx jsou xxxxxxxxx x xxxxxxxx xxxxxxxx. |
(3) |
Xxxxx xxxxxxxxx využíval xxxxxxxx xxx potraviny x xxxxxx xxxxx xxxxxx 6 xxxxxxxx (XX) č. 1451/2007, xxx xxxxxxxxxx xx xx něj xxxxxxx xxx xxxxxxxxx a krmiva xxxxxxx x xx. 2 xxxx. 5 xxxx. x) xxxxxxxx (XX) x. 528/2012, xxxx xx xxx xxxxxx xxxxx, xxxxx xxxxxxxx, xxxxxxxxx x xxxxxxxx xxxxxxxx xxx xxxxxxxxx xxx xxxxxxxxx. X xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xx mělo být xxxxxx xxxxxxxx xx xxx x xxxxxxxxx umožněno až xx xxxxxxxx uvedeného xxxxxxxxx. Xxxxxx xxxxxxxxxxx prohlášení xx xxx xxxxxxx, xxxxx xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxx. Xxxxx xx mělo platit x xxxxxxxxx, kdy xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx x xxxx přípravku xxxxxxxxx x xxxx xxxxxxxx xxxx přípravků v nařízení (XX) x. 528/2012 xxxxxx xxxxxxxx xxxxxxx ve xxxxxxxx 98/8/XX nebo xx xxxxx xxxxxxxxxx xxxxxxxxxxx Xxxxxx xxxxxxxx x xxxxxxx x xx. 3 xxxx. 3 xxxxxxxx (XX) x. 528/2012, xxxxxxxxxxx (xxxxxxxxx xxxxxxxxxxx xx xxxx C-420/10 (4)) xxxx xxxxxxxxx xxxxxx Xxxxxx xx xxxxxxxxxxx xxxxxx xxxxxxxxx států, xxxxx xx xxxxxxxx xxxxxxx. |
(4) |
Xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxx xxxxx, xxxxx xxx xxxx xxxxxxxx do xxxxxxxx xxxxxxxx, z xxxx xxxxx xxxxxxx xxxx xx x xx xxxxxx, avšak xxxxxxxx xx používání xxxxxx xxxxxxxxxx xxxxxxxxx v členském xxxxx nezbytné, xxxx xx být x xxxxx xxxxxxxx xxxxx použití x dodávání na trh xxxxxxxx na xxxx xxxxxxxxxxxx, xx xxxxxxxx xxxxxxxx a po xxxxxxxx xxxx. |
(5) |
X zájmu jednotnosti x xxxxxxxxxxxx xx měl xxx postup hodnocení xxxxxxxx xxxxx x xxxxxxxx xxxxxxxx ve xxxxx xxxxxxxxxx xxxxxxx xxxxxxx x xxxxxxxx stanoveným xxx xxxxxxx xxxxxxxxxx xxxxx článku 7 xxxxxxxx (XX) x. 528/2012 xxxx xxxxx xxxxxxxxxxx xxxxxxxx Xxxxxx (XX) x. 88/2014 (5). |
(6) |
Pro xxxxx, které xxxxxxx xxxxxxxx xxxxxxxxx nebo xxxxxxxx xxx náhradu, xx měl xxxxxxxxx xxxxxxxxx xxxxx předložit xxxxxxxx návrh xxxxxxxxxxxxx xxxxxxxxxxx a označení xxxxx xxxxx xx. 37 odst. 1 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 1272/2008 (6), xxxxx xxx x xxxxxxxxx vlastnosti xxxxxxxxxx xxxxx, x xxxxxxx by xxxx být zachováno xxxxx členského xxxxx xxxxxxxxx xxxxx xxxxxxxx xx xxxxxx xxxx xxxxx xxxxxxxxxxx xxxxxxxxxx. Xxxxxxxxx příslušný orgán xx xxx také xxxxxxxxxxx xxxxxxxx x xxxxxxx xxxxx, které xx splňovaly xxxxxxxx xxx xxxxx xxxxxxxxxxxx, xxxxxxxxxxxxxxx xx xxxxxxx, xxxx xxxxx, xxxxx xx xxxxx být považovány xx látky x xxxxxxxxxxx xxxxxxxxxxxxxx xxxxxxxx endokrinní xxxxxxxx. |
(7) |
Xxx bylo xxxxxxxxx, xx program xxxxxxxx xxxx xxxxxxxx xx xxxxxxxx xxxx xxxxxxxxx x xx. 89 xxxx. 1 xxxxxxxx (XX) x. 528/2012, xxxx xx xx xxxxxxxxx xxxxxx xx kombinace xxxxxx látky a typu xxxxxxxxx, x xxxxx xxxx příslušné xxxxx xxxxxxxxxx xx xxxxxxx xxxxxxxxxxx x xxxxxxxx (XX) x. 1451/2007 xxxx x xxxxx xxxxxxxx. Xxxxx xxxx by xx xxxx xxxxxxxx xxxxxx xxxxx xxx xxxxxxxxx xxxxxxxxx, xxxxxxx xx xx měla xxxx x xxxxx xxxxxxx, xx xxxxxxx xx mohly xxx xxxxxxxxx méně xxx xxx xxxx uplynutím xxxxxx xxxx. |
(8) |
Xxxxxxx xxxxxxxx xx přílohy I xxxxxxxxx 7 nařízení (XX) x. 528/2012 xxxxx xxxxxx xxxxxxxxx xxxxx xxxxxxxxx xx xxxxx. Xx xxxxx vhodné x xxxx xxxx xxxxxx xxxxxxx x xxxxxxxx xx xxxxxxx xxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 nebo 6. |
(9) |
Xxx xxxxxx xx xx. 90 xxxx. 2 xxxxxxxx (XX) č. 528/2012 xxxxxxx z článku 91 xxxxxxxxx xxxxxxxx, xx xxxxxxxx uvedená v článku 10 xxxxxxxxx xxxxxxxx xx xxxx xxx relevantní xxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx přípravků xx xxxxx xxxxxxxxx. Xx proto xxxxxx xxxxx xxxxx xxxxxxxxx tato xxxxxxxx xx xxxxx hodnoceních xxxxxxxx xxxxx. |
(10) |
Xxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xx xxx xxx xxxxxxx xx xx xxxxxxxx dohodě xxxxxxxx ke xxxxxxxxxxx xxxxxxxxxxx xxxx jej xxxxxxxx za xxxxxxxxxxx, xx xxxxx xxxx xxxxxxx xx xxxxxxxx xxxxxxxxx x xxxxxx omezeného xxxxxxxx x xxxxxx, xxxxxxx xxxxx xx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx údaje xxxxx. |
(11) |
Protože xx xxxxx v programu xxxxxxxx dobrovolná, xxxx xx být účastníkům xxxxxxxx od xx xxxxxxxxx. Pokud x xxxx dojde, xxxx xx mít potenciální xxxxxxxxx xxxxxxx převzít xxxxxxx, xxxxxx-xx xxxx xxxxxxxx xxxxxxx již xxxxxx, neboť xxx xxxxxxx ke xxxxxxxx xxxxxxxx přezkumu, a xxxxxxxx-xx agentura xxx xxxxxxxx na xxxx xxxxxxxxxx. |
(12) |
Xxxxx xx při xxxxxxxxx xxxxxx xxxxx xxxxx, xx xxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxxxxx xxxxxxxxxx identitě xxxxxxxx hodnocené xxxxx, x x hodnocení xxxxx xxxxxxx závěry xxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xxxxx, mělo by xxx xxxxx xxxx xxxxx x xxxxxxx xxxxxxxxx xxxxx definovat a povolit xxxxx xxxxxx, xxx xxxxxxxx xxxxxxx této xxxxxxxxx xxxxxxxx látky. |
(13) |
Xxxxxxx xxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxxxxx x xxxx xxxxxxx xxxxxx xxxxxxxx xxxxxxxxxxx xxxxxx účastníkem. Xxxxx xx xxxx xxxxxxxx xxxxxxxxxxxxx, xxxxxx xxxxx xx. 4 xxxx. 4 xxxxxxxx (XX) x. 528/2012 xxxx xxxxxxxxx xxxxx xxxxxxxx, xxxxx xxx xxxx xxxxxxxx xxxxxxxxx. U xxxxxxxxx xxxxx a xxxxxxxxxxxxx xx xxxx xxx osoby xxxxxxx xxxxxxx xxxxx, protože xxxxx by xxxx xxxxx a nanomateriály musely xxx x xxxxxxxx xxxxxxxx xxxxxxxxx. |
(14) |
Aby bylo xxxxxxxxx, že xxxxx xxxxx xxxxxxxxx x xxxxxxxx xxxxxxxxxxx xxx xx xxx nebude xxxxxxxx, xxxx by xxxxxxxx xxxx xxxxxxxxxxx, xxxx xx xxxxxxxx xxxxx, xxxxx xxxxx xxxxxx xxxxxxxxx, x xxxxxxxx xxxx xxxx xxxxxxxx xxxxxxxx oznamování xxxxxxxxxx xxxxx x xx, |
XXXXXXX XXXX XXXXXXXX:
XXXXXXXX 1
PŘEDMĚT X XXXXXXXX
Xxxxxx 1
Xxxxxxx
Xxxx xxxxxxxx xxxxxxx xxxxxxxx xxx xxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx x&xxxx;xxxxxx&xxxx;89 nařízení (XX) x.&xxxx;528/2012.
Xxxxxx 2
Xxxxxxxx
Xxx účely xxxxxx nařízení xx xxxxxxx xxxx xxxxxxxx:
a) |
„rozhodnutím x neschválení“ xx xxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxx čl. 9 xxxx. 1 xxxx. x) xxxxxxxx (XX) č. 528/2012 xxxx xx. 89 odst. 1 třetího xxxxxxxxxxx xxxxxxxxx xxxxxxxx, xxxx xxxxxxxxx nezařadit xx xxxxxxx X xxxx XX xxxxxxxx 98/8/XX; |
b) |
„xxxxxxxxx xxxxx x xxxx přípravku xxxxxxxxx xx xxxxxxxx xxxxxxxx“ xx xxxxxx kombinace xxxxx x xxxx xxxxxxxxx xxxxxxx x xxxxxxx XX, která xxxxxxx xxxx xxxxxxxx:
|
x) |
„účastníkem“ xx xxxxxx xxxxx, která xxxxxxxxxx žádost x xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxxx předložila xxxxxxxx, které xxxxxxxx xxxxxxxxxx xxxxx čl. 17 xxxx. 5 xxxxxx nařízení, xxxx xxxxxx jménem xxxx tato xxxxxx xxxx xxxxxxxx xxxxxxxxxx; |
x) |
„xxxxxxxxxx xxxxxxxxxx xxxxxxx“ se xxxxxx xxxxxxxxx orgán xxxxxxxxx státu xxxxxxxxx x xxxxxxx XX xxxxxx nařízení, určený x xxxxxxx s článkem 81 xxxxxxxx (XX) x. 528/2012. |
XXXXXXXX 2
POSTUP HODNOCENÍ XXXXXXXXXXX
Xxxxxx 3
Xxxxxx o xxxxxxxxx nebo zařazení xx xxxxxxx X xxxxxxxx (XX) x. 528/2012
1.&xxxx;&xxxx;&xxxx;Xxxxxx x&xxxx;xxxxxxxxx xx xxxxxxxx do přílohy X&xxxx;xxxxxxxx (XX) x.&xxxx;528/2012 xxxx xxxxx xxxxx xxxxxxxx, x jehož oznámení xxxxx xxxxxxxx x xxxxxx, xx xxxxxxxx xxxxxxxxxx podle xx.&xxxx;17 xxxx.&xxxx;5 xxxxxx nařízení.
Pokud xx xxxxxx týká xxxxxxxx xx&xxxx;xxxxxxx X&xxxx;xxxxxxxx (XX) x.&xxxx;528/2012, xxxx xx xxxxx pouze xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx xxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxxxxx x&xxxx;xxxxxxxx 1 se xxxxxxxx xxxxxxxx xx&xxxx;xxxx xxx xx xxxxxxxxxx x&xxxx;xxxxxxx x xxxxxxxxx podle xx.&xxxx;17 xxxx.&xxxx;5.
Xxxxxx 4
Xxxxxxx žádostí
1. Agentura xxxxxxxxx xxxxxxxxx x xxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx Xxxxxx (XX) č. 564/2013 (7) x zamítne xxxxxx, xxxxx xxxxxxxx nezaplatí xxxxxxxx ve xxxxx 30 xxx. O xxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxxx xxxxxxxxx xxxxx.
2. Po xxxxxxxx xxxxxxxx splatných podle xxxxxxxxxxx xxxxxxxx (XX) x. 564/2013 xxxxxx xxxxxxxx žádost x xxxxxxxxx x xxx účastníka x xxxxxxxxx xxxxxxxxx xxxxx, xxxxxxx xxxxx xxxxx xxxxxxx xxxxxxx a její xxxxxxxxx xxxxxxxxxxxxx xxx.
3. Xxxxx xxxxxxxxxxx xxxxxxxx podle xxxxxxxx 1 tohoto xxxxxx xxx xxxxx xxxxxxx prostředek x xxxxxxx x článkem 77 xxxxxxxx (XX) x. 528/2012.
4. Xxxxxxxxx příslušný xxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxx splatném xxxxx xx. 80 xxxx. 2 xxxxxxxx (XX) č. 528/2012 xx 30 xxx xxxx, co xxxxxxxx xxxxxxx xxxxxx, a xxxxxxx xxxxxx, xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xx lhůtě 30 xxx. X xxxx xxxxxxxxxxx xxxxxxxxx účastníka x xxxxxxxx.
Xxxxxx 5
Xxxxxxxxx xxxxxxx x schválení xxxx xxxxxxxx do xxxxxxxxx 6 xxxxxxx X xxxxxxxx (EU) č. 528/2012
1. Xxxxx agentura přijme xxxxx čl. 4 xxxx. 2 xxxxxx x xxxxxxxxx xxxx xxxxxxxx xx xxxxxxxxx 6 přílohy X xxxxxxxx (EU) x. 528/2012, xxxxx xxxxxxxx xxxxx xxxxxxxxxx x xxxxxxx x xx. 6 xxxx. 1 x 2 xxxxxxxxx xxxxxxxx, a byl xxxxxxxx xxxxxxxx podle xx. 4 xxxx. 4, xxxxxxxxx xxxxxxxxx xxxxx xxxxxx xxxxxxx xx 30 dnů xx zaplacení poplatků.
2. Pokud xxxxxxxxx xxxxxxxxx orgán xxxxxxx xx xxxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxx (ES) x. 1451/2007, avšak xx xxxxx nebyla xxxxxx xxxx xxxxx podle xxxxxx 13 xxxxxxxxx xxxxxxxx, xxxxxxx hodnotící xxxxxxxxx xxxxx žádost xxxxxxxxxx do 3. xxxxx 2015.
3. X případech xxxxxxxxx x xxxxxxxxxx 1 x 2 xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx xxxxxxx xxx xxxxxxxxxxxx předložených xxxxx xxxx odůvodnění.
4. Pokud xxxxxxxxx xxxxxxxxx xxxxx xxxxxx, xx xxxxxx xx xxxxxxx, xxxxx účastníkovi, xxxx xxxxxxxxxx xxxxxxxxx xxxx x xxxxxxxxx xxxxxxx nutné, a x předložení xxxxxx xxxxxxxxx stanoví xxxxxxxxxx xxxxx. Xxxx xxxxx xxxxx xxxxxxxxxx 90 dnů.
Xxxxxxxx-xx xxxxxxxxx xxxxxxxxx xxxxx, xx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx postačují xx xxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxx 2, xxxxxxx xxxxxx xx 30 xxx xx xxxxxxxx xxxxxxxxxxxx xxxxxxxxx.
Jestliže xxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxxxxxxxx xxxxx xxxxxxxxxx, xxxxxxxxx xxxxxxxxx xxxxx žádost xxxxxxx x xxxxxxxxx x xxxx xxxxxxxxxxx účastníka x agenturu. X xxxxxx xxxxxxxxx se xxxxx xxxxxxxx xxxxxxxxx x xxxxxxx x xx. 80 odst. 1 x 2 xxxxxxxx (EU) x. 528/2012.
Xxx potvrzení žádosti xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxx, xxxxxxxx a další xxxxxxxxx xxxxxx x xxxxx datum xxxxxx xxxxxxxxx.
Xxxxxx 6
Xxxxxxxxx xxxxxxx
1. Tento xxxxxx xx použije, xxxxx xxxxx některá x xxxxxx podmínek:
a) |
je-li žádost xxxxxxxxx podle xxxxxx 5; |
x) |
xxxxx hodnotící xxxxxxxxx xxxxx xxxxx dokumentaci xxxx úplnou podle xxxxxx 13 xxxxxxxx (XX) x. 1451/2007, xxx xxxxx xxxxxxxxxxx Komisi xxxxxx xxxxxxxxxxx orgánu podle xx. 14 xxxx. 4 uvedeného xxxxxxxx; |
x) |
xxxxx xxxxxxxx přijala xxxxxx o xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4 xxxx 5 přílohy I nařízení (XX) x. 528/2012 podle xx. 4 odst. 2 x xxx zaplacen poplatek xxxxx xx. 4 xxxx. 4. |
2. Hodnotící xxxxxxxxx xxxxx xxxxxxxx xxxxxx xxxxx xxxxxx 4 x 5 xxxxxxxx (XX) x. 528/2012 x xxxxxxxx xxx xxxxxxx xxxxxx xx úpravu xxxxxxxxx xx xxxxx xxxxxxxxxx x xxxxxxx x xx. 6 xxxx. 3 xxxxxxxxx nařízení x xxxxx hodnotící xxxxxx a xxxxxx xxxxx xxxxxxxxx xxxxxxxx.
3. Xxxxx xxxxxxx xxxxxxxxx látky x xxxx přípravků xxxxxxxxx xxxxxxx účastníků, xxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxx xxxxx xxxxxxxxx xxxxxx. Xxxxxxxxx xxxxxx a závěry xxxxx x xxxxx x xxxxxx xxxx, xxxxx xxxx, xx xxxxxxx xxxxxxx:
x) |
365 xxx xx xxxxxxxxx xxxxxxxxx xxxxxxxx x xxxx. 1 xxxx. x), xxxxxx úplnosti xxxxxxxx x xxxx. 1 xxxx. x) xxxx xxxxxxxxx poplatku xxxxxxxxx v odst. 1 xxxx. x) x xxxxxxx kombinace xxxxx x xxxx xxxxxxxxx; |
x) |
ve xxxxx xxxxxxxxx x xxxxxxx XXX. |
4. Xxxx xxx, xxx xxxxxxxxx příslušný orgán xxxxxxxx xxx xxxxxx xxxxxxxx, xxxxxx xxxxxxxxxxx xxxxx do 30 xxx k xxxxxxxxx xxxxxx x k xxxxxxx xxxxxxxxx písemné xxxxxxxxxx. Xxxxxxxxx příslušný xxxxx xxxx xxxxxxxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxx x xxxxxxxxx xxxx xxxxx xxxxxxxxx.
5. Xxxxx xx xxxxx, xx jsou x xxxxxxxxx nutné xxxxxxxxxx informace, hodnotící xxxxxxxxx xxxxx účastníka xxxxx, xxx xxxx xxxxxxxxx xx stanovené xxxxx xxxxxxxxx, x xxxxxxxxx x xxx xxxxxxxx.
Xxxxx 365 xxx xxxxxxx v odstavci 3 xx xxxxxxx xx xxxx xxx xxx vznesení xxxxxxxxx xx xxx xxxxxxxx xxxxxxxxx. Pokud to xxxx xxxxxxxxxx xxxxxxx xxxxxxxxxxxx xxxxx xxxx xxxxxxxxxxx xxxxxxxxxx, přerušení xxxxxxxxxx následující xxxxx:
x) |
365 xxx x xxxxxxx, že xx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxxx, xxxxx xxxxxx xxxxxx x xxxxx xxxxxxxx 98/8/XX xxxx v rámci xxxxxxx xxxxxxxxxxx xxx uplatňování xxxxxxx xxxxxxxx; |
x) |
180 dní xx xxxxx ostatních xxxxxxxxx. |
6. Pokud xxxxxxxxx xxxxxxxxx xxxxx xxxxxx, xx existují xxxxx xxxxxxx zdraví xxxx xxxx xxxxxx xxxx xxxxxxxxx xxxxxxxxx vyplývající x xxxxxxxxxxxxx xxxxxx xxxxxxxxxx x xxxxxxxxx biocidních přípravků xxxxxxxxxxxx stejné xxxx xxxxxxxx účinné xxxxx, xxx xxxxx xxxxxxxxxxxx x xxxxxxx x xxxxxxxxx xxxxxxxxxxx xxxxx xxxxxx II xxxx 3 xxxxxxx XX xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 1907/2006 (8) a zahrne xx xx svých xxxxxx.
7. X xxxxxxx xxxxxxx xx xxxxxxxxx hodnocení xxxxxxxxxxxxx hodnotící xxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxx a nejpozději xxx xxxxxxxxxx hodnotící xxxxxx xxxxx xxxxxxxx 3:
x) |
předloží xxxxx agentuře xxxxx xx. 37 odst. 1 xxxxxxxx (XX) x. 1272/2008, xxxxxxxx xx xxxxxxx, xx xx xxxxxxx xxxxx x xxxxxxxx xxxxxxxxx x xx. 36 xxxx. 1 xxxxxxxxx xxxxxxxx, xxx xxxx xxxxxxxx řešeno x xxxxx 3 přílohy VI xxxxxxxxx xxxxxxxx; |
x) |
konzultuje x xxxxxxxxx, xxxxx xx xxxxxxx, xx xxxxx z kritérií xx. 5 xxxx. 1 xxxx. x) xxxx x) xxxxxxxx (XX) x. 528/2012 xxxx xxxxxxxx xx. 10 xxxx. 1 písm. d) xxxxxxxxx xxxxxxxx jsou xxxxxxx, xxx nejsou xxxxxxxx řešeny x xxxxxxx XXX nařízení (ES) x. 1907/2006 xxxx x xxxxxxx xxxxxxxx v čl. 59 odst. 1 xxxxxxxxx xxxxxxxx. |
Xxxxxx 7
Xxxxxxxxxx xxxxxxxx
1. Xxxxx xxxxxx xx xxxxxxx, xxxxx xxxxx některá x xxxxxx xxxxxxxx:
x) |
xxxxx hodnotící xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx xxxxxx xxxxx xx. 6 xxxx. 2 x xxxxxxxx xxxxxxxxx návrh xxxx xxxxxxx xxxxxxxxxx xxxxx xx. 6 xxxx. 7; |
x) |
pokud xxxx xxxxxxxxxx Komisi xxxxxx xxxxxxxxxxx xxxxxx xxxxx xx. 14 xxxx. 4 xxxxxxxx (XX) x. 1451/2007, xxx hodnotící xxxxxx xxxxx xxxxxxxxxxxx Xxxxx xxxxx pro biocidní xxxxxxxxx xxxxx čl. 15 xxxx. 4 uvedeného xxxxxxxx. |
2. Xx xxxxxxx xxxxxx agentura xxxxxxxxx x xxxxxxxx Xxxxxx xxxxxxxxxx x xxxxxxxxx kombinace xxxxx x xxxx xxxxxxxxx xxxx jeho xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx X xxxxxxxx (XX) x. 528/2012, xxxxxxxx xxxxxx, x xxxxxxx xx xxxxxx xxxxxxxxxxx příslušného xxxxxx.
Xxxxxxxx xxxxxx xxxxxxxx xxxxxxxxxx x xxxxx x xxxxxx xxxx, xxxxx toho, xx xxxxxxx později:
x) |
xx xxx měsíců xx xxxxxxx xxxxxx; |
x) |
xx lhůtě xxxxxxxxx v příloze III. |
Xxxxxxxx xxxxxxxx xxxxxxxxxx Xxxxxx xx 270 dnů od zahájení xxxxxxxx.
Xxxxxx 8
Účinné látky, xxxxx xx mají xxxxxxxx
1. Xxx přípravě xxxxx xxxxxxxxxx xxxxx čl. 7 xxxx. 2 agentura xxxxxxx, xxx xxxxxx xxxxx xxxxxxx některé z kritérií xxxxxxxxx x xx. 10 xxxx. 1 xxxxxxxx (XX) x. 528/2012, x xxxx xxxxxx xxxxx xx xxxx stanovisku.
2. Aniž xxxx xxxxxxx xxxxxx 66 x 67 xxxxxxxx (XX) x. 528/2012, xxxxx xxx xxxxxxxx xxxxxxxx xxx xxxxxxxxxx Komisi, xxxxxxxx xxxxxxxxx o možných xxxxxxx, xxxxx xx xxxx xxxxxxxx, xxxxx xxxxxxxxx 60 xxx; x xxxx xxxx xxxxx xxxxxxxxxx xxxxx xxxxxx xxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxx xxxxxxxxx o dostupných xxxxxxxxx. Agentura xxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxx x xxxxxxxxx xxxx xxxxxxxx xxxxx xxxxxxxxxx.
3. Pokud xx xxxxxx xxxxx xxxxxxxxx x xxxxxxx xxxxx x xxxxxxxx xxxxxxxxxxx x xx. 10 xxxx. 1 nařízení (XX) x. 528/2012, musí být xxxxxxxx za látku, xxxxx xx xx xxxxxxxx, x xxxxxxxx xxxxxxxx x xxxxxxx x xx. 89 xxxx. 1 xxxxxx xxxxxxxxxxxx uvedeného xxxxxxxx.
Xxxxxx 9
Xxxxxxxxxx Xxxxxx
Xx xxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx xx. 7 odst. 2 Xxxxxx xxx xxxxxxxxxx xxxxxxxx připraví návrh xxxxxxxxxx xxx přijetí xxxxx čl. 89 odst. 1, xxxx případně xxxxx xx. 28 xxxx. 1 xxxxxxxx (XX) č. 528/2012.
XXXXXXXX 3
ZMĚNY PRVKŮ XXXXXXXX PŘEZKUMU
Článek 10
Připojení xxxx nahrazení xxxxxxxxx xx vzájemné xxxxxx
1.&xxxx;&xxxx;&xxxx;Xxxx xxxxxxxxx je možno xx vzájemné xxxxxx xxxx xxxxxxxxxx xxxxxxxxxx x xxxxxxxxxxxx účastníkem xxxxxxx xxxx xxxxxx xx xxxxxxxxxxx, xx xx potenciální xxxxxxxx xxxxx xxxxxxxxx xx xx xxxxxxx xxxxx xxxxxxxxxx xxxx uvedené xxxxxxxxxx účastníkem.
2. Oznámení xxx xxxxx xxxxxx xxxxxx xxxxxxxxxxx xxxxxxxx společně xxxxxxxxxxx x&xxxx;xxxxxxxxx xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx pro xxxxxxxx xxxxxxxxx xxxxxxxxx x článku 71 xxxxxxxx (XX) x. 528/2012 (xxxx jen „xxxxxxxx“) x&xxxx;xxxxxxxx musí xxxxxxxxx všechna příslušná xxxxxxxx x xxxxxxxx.
3.&xxxx;&xxxx;&xxxx;Xx xxxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxx odstavce 2 agentura xxxxxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxx xxxxxxxx xx totožnosti xxxxxxxxx.
4.&xxxx;&xxxx;&xxxx;Xxxxx xxxxxxx xx&xxxx;xxxxx Xxxx, xxxxx xxxxxxxx roli xxxxxxxxx xxxx xx xxxxxxxxx x účastníkovi xxxxx tohoto článku, xx pro účely xxxxxx 95 nařízení (XX) x.&xxxx;528/2012 považována xx xxxxx, která xxxxxxxxxx dokumentaci nebo xxxxxxxx x xxxxxxxx x xxxxxxxxxxx.
Xxxxxx 11
Xxxxxxxxxx xxxxxxxxx
1. Má xx xx xx, xx účastník xxxxxxxxx x účasti xx xxxxxxx kombinace xxxxx x xxxx xxxxxxxxx v programu xxxxxxxx, v xxxxxx xxxxxxxxx:
x) |
xxxxx xxxxxxxxxx xxxxxxxx xxxx xxxxxxxxx xxxxxxxxx xxxxx prostřednictvím xxxxxxxxx x xxxx xxxxxx xxxxxxxxx; |
x) |
xxxxx xxxxxxxxxxx žádost xx lhůtě uvedené x xx. 3 odst. 2; |
x) |
xxxxx xxxx xxxxxx xxxx zamítnuta xxxxx čl. 4 xxxx. 1, xx. 4 odst. 4 xxxx xx. 5 xxxx. 4; |
x) |
xxxxx nepředložil xxxxxxxxxx xxxxxxxxx xx xxxxxxx uvedených x xx. 6 xxxx. 5; |
x) |
xxxxx xxxxx xxxxxxxxxx xxxxxxxx hodnotícímu xxxxxxxxxxx xxxxxx nebo agentuře. |
2. Xxxxxxxxxx xx xxxxxxxx xx xxxxxxxxx včas, pokud x xxxx xxxxxxx xx xxxx, xxx xxxxxxxxx xxxxxxxxx orgán xxxxxxxxx xxxxxxxx xxxxxx xxxxxxxxxxx orgánu xxxxx xx. 6 xxxx. 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 xxx xxxxxxxxxx odkladu prostřednictvím xxxxxxxxx.
2. Xxxxx xx o xxxxxxx odstoupení xxxxxxxxxxx xxxxxxxx, xxxxxxxxxxx xxxxxxxxx x xxxxxxxxx týkající se xxxxxxxxxx účastníka.
3. Xxxxx x xxxxxxxx přezkumu xxxx xxxxxxxxxx xxxxxxx účastníci xxxxxxxxxxx tutéž kombinaci xxxxx x xxxx xxxxxxxxx x xxxxx xxxx role xxxxxxxxx xxx xxxxxxxx xxxxxxxxx xxxxx xxxxxxxx, xxxxxxxxx o tom xxxxxxxx xxxxxxxxxxxxxxx rejstříku Xxxxxx.
Xxxxxx 13
Xxxx xxxxxxxx xxxxxxxxx xxxxx
1. Xxxxx hodnocení xxxxxxxxx xxxxxx xxxxx xxxxxxxx vyvodit xxxxxx xxxxxxxx xx xxxxx, xxx xxxx xxxxxxx x xxxxxxx XX, xxxxxxxxx příslušný xxxxx xx xxxxxxxxxx x dotyčným xxxxxxxxxx xxxxxxx xxxxx xxxxxxxx xxxxx. Xxxxxxxxx xxxxxxxxx xxxxx o tom xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx x xxxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxx.
Xxxxxx 14
Xxxxxxxx role xxxxxxxxx
1. Xxxxxxxx xxxxxxxx xxxxxxxxx xxxxx x převzetí xxxx xxxxxxxxx pro xxxxxxxxx látky x xxxx xxxxxxxxx, pokud xxxxxxx xxxxx x xxxxxx xxxxxxx:
a) |
xxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx včas xxxxxxxxxx xxxxx článku 11 x xxxxxx role xxxxxxxxx xxx xxxxx kombinaci xxxxxx předtím xxxxxxxx; |
b) |
xx xxxxxxx xxxx xxxxxxxx xxxxx xxxxxx 13; x xxxxx xxxxxxx xx xxxxx týká xxxxx xx xxxxx, xx xxxxxx xx xxxxxxxx xxxxxxxxx identita v příloze II, xxx xxxxxxx nová xxxxxxxx xxxxx. |
2. Xx xxxxxxxx měsíců xxx xxx xxxxxxxxxx xxxxx xxxxxxxx 1 xxxx xxxxxxxxx osoba xxxxxxxxx xxxxxxxx xxx xxxxxxxxx xxxxx xxxxxx 17.
3. Xx xxxxxxxx měsíců xx xxxx xxxxxx xxxxxx nařízení x xxxxxxxx xxxx xxxxxxxxx xxxxx oznámit xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx do části 2 xxxxxxx XX podle xxxxxx 17.
Xxxxxx 15
Kombinace xxxxx x typu xxxxxxxxx xxxxxxxxx pro xxxxxxxx xx programu xxxxxxxx
Xxxxx xxxxxxxx xxxxxxxxx, xxxxx xxxxx xx xxxxxxx xxxxxxxxxx xxxxxxxx (XX) x. 528/2012 x xx xxxxxx xx xxx, xxxxxxx xx xxxxxxxxx xxxxxx látky, jež xxxx xxxxxxxxx xxx xxxxxxxx xx xxxxxxxx xxxxxxxx pro xxxxx xxx xxxxxxxxx a xxxx xxxxxxxx xx xxxxxxx I xxxxxxxxx xxxxxxxx, xxxx látku xxxxxxxx nebo xx x xx xxxxxx, xx xxxxxxx xxxxx xxxxxxxxx xxx xxxxxxxx xx xxxxxxxx xxxxxxxx pro xxxxxxxxx xxx xxxxxxxxx xx xxxxxxx xxxxxxxxx x xxxxxx xxxxxx:
x) |
xxxxx xxxxxxxxx výrobek xx xxx xx spoléhala xx pokyny xxxx xxxxxxx xxxxxxxxxx vydané Xxxxxx nebo xxxxxxxxxx xxxxxxx xxxxxxxxxx x xxxxxxx x xxxxxxx 26 xxxxxxxx 98/8/XX xxxx xxxxxxx 81 xxxxxxxx (XX) č. 528/2012, xxxxx na xxxxxxx xxxxxxxxxx xxxxxxxxxxxxxx xxxxxx xxxxx xxxxxxx xxxxxx xx xxxxxxxxxx k xxxxxxxxxxx, xx xxxxxxx xxx xxxxx x xxxxxxxxxx směrnice 98/8/XX nebo xxxxxxxx (XX) x. 528/2012, xxxx xx xxx xxxxxxxxx xxx xxxxxxxxx xxxxxx x přípravků, pro xxxxx xxxx xxxxxx xxxxx oznámena, x xxxxx xxxx xxxxxxx xxxxxx xx xxxxxxxxxx xxxxxxxx přezkoumány x xxxxxxxxxx xxxxxxxx xxxxx xx. 3 xxxx. 3 xxxxxxxx (XX) č. 528/2012 xxxx v nových, závazných xxxxxxxx zveřejněných Komisí; |
x) |
látka xxxxxxxxx xxxxxxxx pro xxxxxxxxx x xxxxxx xxxxxxxxx x xxxxxx 6 nařízení (XX) x. 1451/2007; |
x) |
xxxxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxx (XX) x. 528/2012 k xxxxxxxxx xxxx xxxxxxxxx, xxx tomu xxxx xxxxx xxxxxxxx 98/8/XX, x xxxxxxxx xxxxx xxxxxxxxxx xxxxxx xxxx xxxxxxxxx x xxxxxxxx xxxxx zařazenou do programu xxxxxxxx xxx původní xxx přípravku, ale xxxxxx xxx xxxx. |
Xxxxxx 16
Prohlášení x xxxxx xx oznámení
1. Xxxxxxxxxx x xxxxx oznámit xxxxx, xxxxx xx způsobilá xxx xxxxxxxx do programu xxxxxxxx xxxxx článku 15, předkládá prostřednictvím xxxxxxxxx kterákoli xxxxx, xxx xx zájem xxxxxxx kombinaci xxxxx x xxxx xxxxxxxxx, jednomu x následujících xxxxxxxx:
a) |
Komisi xxxxxxxxxx xxxxxxx měsíců xx zveřejnění rozhodnutí xxxx xxxxxx uvedených x xx. 15 písm. a); |
x) |
agentuře xxxxxxxxxx 30. xxxxx 2015 x xxxxxxxxx xxxxxxxxx x xx. 15 písm. b); |
x) |
Komisi xxxxxxxxxx 30. října 2015 v xxxxxxxxx xxxxxxxxx v xx. 15 xxxx. x). |
2. Xxxxxxxxxx xxxx obsahovat xxxxxxxxxx kombinaci xxxxx x xxxx xxxxxxxxx. X xxxxxxxxx xxxxxxxxx x xx. 15 xxxx. x) musí xxxxxxxxxx xxxxxxxxx xxxxxxxxxxxx odůvodnění, x xxxx vyplývá, xx xxxx splněny xxxxxxx xxxxxxxx v xxx xxxxxxx.
3. Xxxxx bylo xxxxxxxxxx učiněno v případě xxxxxxxx v čl. 15 xxxx. x) nebo c) x Xxxxxx xxxxxxx xx xxxxxxxxxx s členskými xxxxx x xxxxxx, že xxxxxxxx 6 xxxx xxxxxxxxxx, a případně, xx xxxx xxxxxxx podmínky xxx xxxxxxxx uvedené x xx. 15 xxxx. a), xxxxxxx x tom xxxxxxxx.
4. Xxxxx bylo xxxxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 xxxx. x) xxxx xxxxx Xxxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 3, xxxxxxxx xxxxxxxx xxxx xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx x xxxxxxxx příslušné xxxxxxxxx xxxxx a typu xxxxxxxxx. Xxx účely xxxxxx nařízení se xxxxxxxxxx xxxxx xx. 3x xxxx. 3 třetího xxxxxxxxxxx xxxxxxxx (ES) x. 1451/2007 xxxxxxxx xx zveřejnění xxxxx tohoto xxxxxxxx.
5. Xxxxxxxxx xxxxx, xxxxx xx xxxxx xxxxxxx kombinaci xxxxx x typu xxxxxxxxx, tak může xxxxxx xxxxx článku 17 xx xxxxx měsíců xxx dne xxxxxxxxxx xxxxx xxxxxxxx 4.
6. X xxxxxxxxx xxxxxxxxx v xx. 15 xxxx. x) x x) se xxxxxxxxx látky x xxxx xxxxxxxxx xxxxxxxx za xxxxxxxxx xxxxxxxxxx x xxxx xxxxxxxxx x xxxxxxx xxxxxxxx, pokud jsou xxxxxxx xxxx xxxxxxxx:
x) |
příslušná xxxxxx látka xx xxx zařazena xx xxxxxxxx xxxxxxxx; |
x) |
xxxxxxxxxxx předložená hodnotícímu xxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxx látku xxx xxxxxxxx všechny xxxxx, xxxxx xxxx xxxxxxxx xxx xxxxxxxxx xxxx přípravku; |
x) |
xxxxxxxx, xxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxxx, xxxxx, xx xx xxxxx o podporu xxxx xxxxxxxxx xxxxx x xxxx přípravku. |
Xxxxxx 17
Postup oznámení
1. Xxxxxxxx xxxxx xx. 14 xxxx. 2 x 3 xxxx xx. 16 odst. 5 xx xxxxxxxxxxx agentuře xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxxxxx musí xxx xxxxxxxxxx xx xxxxxxx XXXXXX. Xxxx xxxxxxxxx xxxxx xxxxxxx x xxxxxxx X.
3. Pokud xxxx x xxxxxxx XX xxx dotyčnou xxxxxxx xxxxx xxxxxx xxxxxxxxx xxxxxxxxx xxxxx, xxxxxxxxx oznamovatel agenturu x xxxxx jím xxxxxxxxx xxxxxxxxxxx xxxxxx, xxxxx xx jmenován v souladu x xxxxxxx 81 xxxxxxxx (XX) x. 528/2012, x xxxxxxxx písemné xxxxxxxxx xxxxxxxxxxx, xx xxxxxxxxx xxxxx xxxxxxxx x xxx, xx dokumentaci xxxxxxx.
4. Xx xxxxxxxx xxxxxxxx x xxx xxxxxxx xxxxxxxx Xxxxxx x xxxxxxxxxxxx xxxxxxxxx o poplatcích xxxxxxxxx xxxxx xxxxxxxx (XX) x. 564/2013. Jestliže xxxxxxxxxxx xxxxxxxx xxxxxxxx xx 30 xxx xx xxxxxxx uvedené xxxxxxxxx, xxxxxxxx oznámení xxxxxxx x uvědomí x xxx xxxxxxxxxxxx x Xxxxxx.
5. Xx xxxxxxxx xxxxxxxx xxxxxxxx xx 30 dnů ověří, xxx oznámení xxxxxxxx xxxxxxxxxx xxxxxxxx v xxxxxxxx 2. Pokud xxxxxxxx xxxxx xxxxxxxxxx xxxxxxxxxx, xxxxxxxx agentura xxxxxxxxxxxx lhůtu x xxxxx 30 xxx, xxx xxx xxxxxxxx xxxxxxx nebo xxxxxxx. Xx uplynutí xxxx 30xxxxx lhůty agentura xx 30 xxx xxx xxxxxxxx, xx xxxxxxxx xxxxxxxx požadavkům xxxxxxxx 2, xxxx xxxxxxxx xxxxxxx, x xxx xxxxxxxxxx sdělí xxxxxxxxxxxx x Komisi.
6. V xxxxxxx x xxxxxxx 77 xxxxxxxx (XX) x. 528/2012 xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 4 xxxx 5 xxxxx opravný xxxxxxxxxx.
7. Xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxx xxxxxxxx 5:
x) |
x xxxxxxx, xx bylo xxxxxxxx xxxxxxxxxx xxxxx xx. 14 xxxx. 2 nebo 3, xxxxxxxx neprodleně xxxxxxxxxxx xxxxxxxxx v xxxxxxxxx xxxxxxxx xx xxxxxxxxxx účastníka a xxxxxxxx xxxxxxxx xxxxx; |
x) |
x xxxxxxx, že oznámení xxxx xxxxxxxxxx xxxxx čl. 16 xxxx. 5, xxxxxxxx xxxxxxxxxx xxxxxxxxx Xxxxxx, xx xxxxxxxxxx bylo xxxxxxxx. |
Xxxxxx 18
Zařazení do xxxxxxxx xxxxxxxx
Xxxxx xx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxxx za xxxxxxxxx x xxxxxxx s čl. 16 xxxx. 6 nebo xxxxx xxxxxxxx xxxxxxxxx Xxxxxx x dodržení požadavků x souladu s čl. 17 xxxx. 7 písm. b), zařadí Xxxxxx kombinaci látky x xxxx přípravku xx xxxxxxxx xxxxxxxx.
Xxxxxx 19
Xxxxxxxxx o xxxxxxx, které nejsou xxxxxx xxxxxxxxxxx x xxxxx xxxxxxxx xxxxxxxx
Pokud xxxxxx xx xxxxx xxxxxxxxx x xx. 16 odst. 5 xxxxxxxx xxxxx oznámení xxxx xxxxx xxxx xxxxxxxx xxxxxxx xx xxxxxxxx xxxxxx přijata a následně xxxxxxxxx xxxxxxxxx podle xx. 17 xxxx. 4 xxxx 5, agentura o tom xxxxxxxxx xxxxxxx xxxxx xxxxxxxxxxxxxxx xxxxxxxxx x xxxxxxxx xxxx xxxxxxxxx elektronickou xxxxxx.
Xxxxxx 20
Xxxxxxxxxx Komise x xxxxxxx, xxxxx xxxxxx xxxxxx xxxxxxxxxxx x rámci xxxxxxxx xxxxxxxx
Xxxxxx xxxxxxxx xxxxx xxxxxxxxxx x xxxxxxxxxxx xxxxx xx. 89 xxxx. 1 xxxxxxx xxxxxxxxxxx xxxxxxxx (XX) x. 528/2012 x xxxxxx xxxxxxxxx:
x) |
xxxxx agentura informuje Xxxxxx x xxxxxxx xxxxxxxxxx xxxxxxxxx podle čl. 12 xxxx. 3 xxxxxx xxxxxxxx; |
x) |
pokud xxxxx osoba xxxxxxxx xxxxxxxx xx xxxxxxx xxxxxxxxxxx x xx. 14 xxxx. 2 nebo 3 xxxxxx nařízení xxxx xxxxx bylo xxxxxxxx předloženo a zamítnuto xxxxx xx. 17 odst. 4 xxxx 5; |
x) |
xxxxx bylo xxxxxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx x xx. 14 xxxx. 2 xxxx 3 xxxxxx xxxxxxxx a byly xxxxxxxx xxxxxxxxx podle čl. 17 xxxx. 5 tohoto xxxxxxxx, xxx xxxxxxxx xxxxx x xxxxxxxx xxxxxxxx pouze xxxx stávající identity x xxxxxxx XX tohoto xxxxxxxx. |
X xxxxxxx xxxxxxxx x xxxxxx pododstavci xxxx. x) xx xxxxx xxxxxxxxxx x xxxxxxxxxxx xxxxxxxx na xxxxxx xxxxx, xx xxxxxx xx vztahuje xxxxxxxxx xxxxxxxx x xxxxxxx XX xxxxxx xxxxxxxx, avšak xxxxxx xxxxxxxx xxxx xxxxxxxx xxxxxxxxxx x xxxxxxxxx.
XXXXXXXX 4
XXXXXXXXX OPATŘENÍ
Článek 21
Xxxxxxxxx xxxxxxxx pro xxxxx uvedené x&xxxx;xxxxxx&xxxx;15
1.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx nebo praxe xxxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxxxx xxxxxxxxxx xxxxxxxxx, který xxxxxxx ze stávající xxxxxx xxxxx xxxxxxx x xx. 15 xxxx. x) a x), xxxx látku xxxxxxxx xxxx z xx vzniká. X xxxxxx xxxxxxxxx:
x) |
xxxxx xxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx na trh s účinkem xx&xxxx;24 xxxxxx xx xxxx xxxxxx xxxxxx xxxxxxxx v platnost; |
b) |
stávající xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxx xxxx využívány xx&xxxx;30 xxxxxx xx xxx xxxxxx tohoto xxxxxxxx x&xxxx;xxxxxxxx. |
2.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx xxxx xxxxx xxxxxxxx xx&xxxx;xxx a používání biocidního xxxxxxxxx, xxxxx sestává xx xxxxxxxxx účinné xxxxx uvedené x xx. 15 písm. x), tuto xxxxx xxxxxxxx xxxx x xx vzniká. V xxxxxx případech:
a) |
nesmí xxx xxxxxxxx přípravek nadále xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;24 xxxxxx po xx z xxxx xxxxxxxxx xxxxxxxx, xxxxx xxxxxxx xxxxxxx:
|
x) |
xxxxxxxxx xxxxxx xxxxxxxxxx přípravku xxxxx být dále xxxxxxxxx xx&xxxx;30 měsíců xx té z xxxx uvedených xxxxxxxx, xxxxx xxxxxxx později:
|
3.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx může xxxxxxxxxx x&xxxx;xxxxxxxxxxx svého xxxxxxxxxxx xxxxxxx xxxx xxxxx xxxxxxxx na trh x&xxxx;xxxxxxxxx biocidního přípravku, xxxxx sestává xx xxxxxxxxx xxxxxx xxxxx xxxxxxxxxx xxxxxxxxx xxxxx xx. 16 xxxx. 4 xxx xxxxxxxxx xxx xxxxxxx, tuto xxxxx xxxxxxxx nebo x xx vzniká. X xxxxxx xxxxxxxxx:
x) |
xxxxx xxx xxxxxxxx přípravek xxxxxx xxxxxxx na trh x&xxxx;xxxxxxx xx&xxxx;xxxxxxxx xxxxxx xx xxxx, xxx xxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxx článku 19 x |
x) |
xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxx dále xxxxxxxxx xx&xxxx;xxxxxxxx xxxxxx xx xxxx xxxxxxxxx xxxxxxxxxx. |
Xxxxxx 22
Nezbytná xxxxxxx
1. Xxxx xx xxxxxx xx. 55 xxxx. 1 xxxxxxxx (XX) x. 528/2012, do osmnácti měsíců xx xxxx xxxxxxxxxx o neschválení xxxxxxxxx xxxxxx xxxxx, xxxxx členský xxxx xxxxxxxx xxxx xxxxxxxxx xxxxxxx látku xx xxxxxxxxx x xxxxxx xxxxxxxxx x xx. 5 xxxx. 2 xxxxxx xxxxxxxxxxx xxxx. x) xxxx x) xxxxxxxx (XX) x. 528/2012, xxxxx xxxxxxx xxxx může xxxxxxxxx Xxxxxx odůvodněnou žádost x xxxxxxxx xx xx. 89 xxxx. 2 xxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx členský xxxx xxxxxxxx odůvodněnou xxxxxx xxxxxxxx xxxxxxxxxxxxxxx rejstříku. Xxxxx xxxxxx xxxxxxxx xxxxxxx xxxxxxxxx, žádající xxxxxxx xxxx musí xxxxxxx xxxxxxxxx nedůvěrné xxxxx.
3. Xxxxxxxx xxxxxxxx xxxxxx xxxx případně xxxxxxxxxx xxxxx xxxxxxxxxxxxxx prostředky. Xxxxxxx xxxxx nebo xxxx osoby xxxxx xxxxx připomínky ve lhůtě 60 xxx xx xxxxxxxxxx.
4. Xx xxxxxxx xxxxxxxxxx xxxxxxxxxx xxxx Xxxxxx xxxxxxx xxxxxxxx xx xx. 89 xxxx. 2 xxxxxxx xxxxxxxxxxx xxxxxxxx (XX) x. 528/2012, xxxxx xxxxxx uvádět xxxxxxxx xxxxxxxxx, jež xxxxxxxxx x této xxxxx, xxxxxxxx xx xxxx x xx xxxxxxxx, xx trh xxxxxxxxxx xxxxxxxxx xxxxx x xxxxxxxx je v daném xxxxxxxx státu v souladu x xxxxxxxxxxxxxx xxxxxxxx xxxxxxxx x x xxxxxxxx xxxxxxxx xxxxxxxx 5 a veškerých dalších xxxxxxxx xxxxxxxxx Xxxxxx.
5. Xxxxxxx xxxx, xxxxx xx xxxxxxxx odchylka:
x) |
xxxxxxx, xx xxxxx xxxxxxxxx xxxx xxxxxxx xx xxxxxx případy x xxxxxxx xxxx, kdy xxxx xxxxxx xxxxxxxx xxxxxxxx 1; |
x) |
xxxxxx vhodná xxxxxxxx xx xxxxxxxx rizik, xxx xxxxxxxx xxxxxxxxxxxx expozice xxxxxxx, xxxxxx xxxx xxxxxxxxx prostředí; |
c) |
zajistí, aby xx hledala alternativní xxxxxx nebo xxx xxxx včas xxxx xxxxxxxxx platnosti xxxxxxxx xxxxxxxxxx xxxxxx o schválení xxxxxx xxxxx x xxxxxxx xxxxxxx 7 xxxxxxxx (XX) x. 528/2012. |
XXXXXXXX 5
XXXXXXXXX XXXXXXXXXX
Xxxxxx 23
Xxxxxxx
Xxxxxxx xx nařízení (XX) x. 1451/2007.
Odkazy xx zrušené xxxxxxxx xx xxxxxxxx xx xxxxxx xx xxxx xxxxxxxx.
Xxxxxx 24
Vstup x xxxxxxxx
Xxxx xxxxxxxx vstupuje x platnost dvacátým xxxx po xxxxxxxxx x Úředním xxxxxxxx Xxxxxxxx xxxx.
Xxxx nařízení xx xxxxxxx x xxxxx xxxxxxx x xxxxx xxxxxxxxxx xx všech xxxxxxxxx xxxxxxx.
X Bruselu xxx 4. xxxxx 2014.
Xx Xxxxxx
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Xxxx Xxxxxx XXXXXXX
(1)&xxxx;&xxxx;Xx. xxxx. L 167, 27.6.2012, x. 1.
(2)&xxxx;&xxxx;Xxxxxxxx Komise (XX) x. 1451/2007 xx xxx 4. prosince 2007 x xxxxx xxxxx xxxxxxxxxxxx pracovního xxxxxxxx xxxxxxxxx x xx. 16 xxxx. 2 xxxxxxxx Evropského xxxxxxxxxx x Xxxx 98/8/XX x uvádění xxxxxxxxxx xxxxxxxxx xx xxx (Úř. xxxx. X 325, 11.12.2007, x. 3).
(3)&xxxx;&xxxx;Xxxxxxxx Evropského xxxxxxxxxx x Xxxx 98/8/XX xx dne 16. xxxxx 1998 x xxxxxxx xxxxxxxxxx xxxxxxxxx xx trh (Xx. xxxx. X 123, 24.4.1998, s. 1).
(4) Rozsudek Xxxxxxxx dvora (xxxxxxx xxxxxx) ze xxx 1. xxxxxx 2012 (žádost x xxxxxxxxxx x xxxxxxxxx xxxxxx: Landgericht Xxxxxxx – Německo) – Xöxx XxxX xxxxx Xxxxx GmbH (xxxxxxx xxxxxxxxxx xxxxxxxxx xx xxx – směrnice 98/8/XX – xx. 2 odst. 1 xxxx. a) – xxxxx „xxxxxxxx xxxxxxxxx“ – xxxxxxxxx, xxxxx xxxxxxxxx vločkování xxxxxxxxxx xxxxxxxxx, xxxx xx xxxx, xxxxxxxx xxxx xxxxxxxxxxx), X-420/10.
(5)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Xxxxxx (XX) č. 88/2014 xx xxx 31.&xxxx;xxxxx 2014, xxxxxx xx xxxxxxx xxxxxx xxx xxxxx xxxxxxx X&xxxx;xxxxxxxx Xxxxxxxxxx xxxxxxxxxx a Rady (EU) x.&xxxx;528/2012 o dodávání xxxxxxxxxx xxxxxxxxx xx xxx x&xxxx;xxxxxx xxxxxxxxx (Xx. xxxx. L 32, 1.2.2014, x. 3).
(6)&xxxx;&xxxx;Xxxxxxxx Evropského xxxxxxxxxx x Xxxx (XX) x. 1272/2008 ze xxx 16. xxxxxxxx 2008 o xxxxxxxxxxx, xxxxxxxxxx a xxxxxx xxxxx x xxxxx, x xxxxx x xxxxxxx xxxxxxx 67/548/XXX x 1999/45/ES x x xxxxx xxxxxxxx (XX) č. 1907/2006 (Xx. xxxx. L 353, 31.12.2008, x. 1).
(7)&xxxx;&xxxx;Xxxxxxxxx nařízení Xxxxxx (XX) x.&xxxx;564/2013 xx xxx 18.&xxxx;xxxxxx 2013 x&xxxx;xxxxxxxxxx a platbách splatných Xxxxxxxx xxxxxxxx xxx xxxxxxxx xxxxx xxxxx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (EU) x.&xxxx;528/2012 x&xxxx;xxxxxxxx biocidních xxxxxxxxx xx trh a jejich xxxxxxxxx (Xx.&xxxx;xxxx.&xxxx;X 167, 19.6.2013, x. 17).
(8) Nařízení Evropského xxxxxxxxxx x Rady (ES) x. 1907/2006 xx xxx 18. xxxxxxxx 2006 x registraci, xxxxxxxxx, povolování a xxxxxxxxx chemických látek, x xxxxxxx Xxxxxxxx xxxxxxxx xxx chemické xxxxx, x xxxxx xxxxxxxx 1999/45/XX x x zrušení nařízení Xxxx (XXX) x.&xxxx;793/93, xxxxxxxx Xxxxxx (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 (Xx. xxxx. X 396, 30.12.2006, x. 1).
XXXXXXX I
Informace xxxxxxxxxx xxx xxxxxxxx xxxxx xxxxxx 17
Oznámení xxxxx xxxxxx 17 xxxxxxxx xxxx informace:
1) |
xxxxx, xx xxxxx xx xxxxxxxxx xxxxxxx xxxxxx xx xxxxxx xx. 3 xxxx. 1 písm. d) xxxxxxxx (XX) č. 528/2012; |
2) |
xxxxx x xxxx/xxxxxx přípravku, na xxxxx/x xx xxxxxxxx xxxxxxxx; |
3) |
xxxxxxxxx x xxxxx xxxxxxxx, xxxxx xxxx xxxxxx xxx xxxxx xxxxxxx x xxxxxxxxx xx zařazení xx xxxxxxx X xxxxxxxx (XX) x. 528/2012, jakož i očekávané xxxxx xxxxxx xxxxxxxxx; |
4) |
informace xxxxxxx v oddílech
|
5) |
xxxxx xxxx toto xxxxxxxx xxxxxxx v případě xxxxxxxx x xx. 15 xxxx. x), xxxxx, že látka byla xx xxxx xxxx xxxxxx xxxxx biocidního přípravku xxxxxxxxxxx xx xxxxxxxxxxx xxxx xxxxxxxxx x xxx xxxxxxxx xxxx xxxxxxxxxx xxxxxxxxxx xxxx xxxxxx xxxxxxxxx xx xxxxxxxx xxxxxxx. |
XXXXXXX XX
XXXXXXXXX LÁTKY X XXXX PŘÍPRAVKU XXXXXXXX XX XXXXXXXX XXXXXXXX XXX 4. SRPNA 2014
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Xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxxxx xx xxx 4. xxxxx 2014, x xxxxxxxx xxxxxxxxxx jiných xxxxxxxxxxxxx xxx xxxx, xxxxx xxxx výslovně uvedeny x xxxxxxxxx 1017 a 1019.
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kyselina salicylová |
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2-isopropenyl-8,9-dimethoxy-1,2,6,6a,12,12a-hexahydrochromeno[3,4-b]furo[2,3-h]chromen-6-on (rotenon) |
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xxxxxxxxxxxxxxx-xxxxxxx/1-xxxxxxxxxxxxxxxx-1-xxx-xxxxxxx |
XX |
204-593-9 |
123-03-5 |
|
x |
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179 |
oxid uhličitý |
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 |
xxxxxxxxxxxxxx, sodná xxx (xxxxx sůl xxxxxxxxxxxxxxx – chloramin X) – (X-xxxxx-4-xxxxxxxxxxxx-1-xxxxxxxxxx |
XX |
204-854-7 |
127-65-1 |
|
x |
x |
x |
x |
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187 |
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 |
natrium-bifenyl-2-olát |
ES |
205-055-6 |
132-27-4 |
x |
x |
x |
x |
|
x |
x |
|
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 |
xxxxxx |
XX |
206-354-4 |
330-54-1 |
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x |
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x |
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239 |
karbamonitril |
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 |
N-[(dichlorfluormethyl)sulfanyl]-N′,N′-dimethyl-N-(4-methylfenyl)sulfonamid (xxxxxxxxxxxx) |
XX |
211-986-9 |
731-27-1 |
|
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x |
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x |
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283 |
xxxxxxxxx |
XX |
212-950-5 |
886-50-0 |
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x |
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x |
x |
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288 |
X-[(xxxxxxxxxxxxxxxxxx)xxxxxxxx]-X-xxxxx-X′,X′-xxxxxxxxxxxxxxxx (xxxxxxxxxxxxx) |
UK |
214-118-7 |
1085-98-9 |
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x |
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x |
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289 |
xxxxxxxxxxxx xxxxx |
FR |
214-183-1 |
1111-67-7 |
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x |
|
292 |
[(1,3-xxxxx-1,3,4,5,6,7-xxxxxxxxx-2X-xxxxxxxx-2-xx)xxxxxx]-xxxxx-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxx-xxxxxxxxxxxx) |
XX |
214-619-0 |
1166-46-7 |
|
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x |
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958 |
xxxxxxxx xxxxxxxx/xxxxxxxxxxx xxxxx/xxxxxx xxxxx |
XX |
215-137-3 |
1305-62-0 |
|
x |
x |
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959 |
xxxx vápenatý/vápno/pálené vápno/nehašené xxxxx |
XX |
215-138-9 |
1305-78-8 |
|
x |
x |
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306 |
xxxx xxxxx |
FR |
215-270-7 |
1317-39-1 |
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x |
|
315 |
butan-2-on-peroxid |
XX |
215-661-2 |
1338-23-4 |
x |
x |
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321 |
xxxxxxxxxxx |
XX |
217-129-5 |
1746-81-2 |
|
x |
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330 |
N-(3-aminopropyl)-N-dodecylpropan-1,3-diamin (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 (BIT) |
XX |
220-120-9 |
2634-33-5 |
|
x |
|
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|
x |
|
|
x |
|
x |
x |
x |
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|
341 |
2-xxxxxxxxxxxxxxxxxxxxxxxxxx-3(2X)-xx (MIT) |
SI |
220-239-6 |
2682-20-4 |
|
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|
x |
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x |
x |
x |
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346 |
xxxxxxx-xxxxxxxxxxxxxxxxxx xxxxxxxx |
XX |
220-767-7 |
51580-86-0 |
|
x |
x |
x |
x |
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x |
x |
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345 |
xxxxxxx-xxxxxxxxxxxxxxxxxx |
XX |
220-767-7 |
2893-78-9 |
|
x |
x |
x |
x |
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x |
x |
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348 |
xxxxx(xxxxxxxxx)xxxxxxxxxxxxxxx-xxxxx-xxxxxx (XXX) |
XX |
221-106-5 |
3006-10-8 |
x |
|
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354 |
xxxxxxxxx |
XX |
222-182-2 |
3380-34-5 |
x |
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359 |
(xxxxxxxxxxxx)xxxxxxxxxx (reakční xxxxxxxx xxxxxxxxxxxxxx x xxxxxxxxxxxxxxxx (XXXxxx)) |
XX |
222-720-6 |
3586-55-8 |
|
x |
|
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|
x |
|
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x |
x |
x |
|
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|
365 |
xxxxxxx-2-xxxxx-1-xxxx, xxxxx xxx (pyrithion xxxxx) |
XX |
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 |
|
|
|
|
|
x |
|
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|
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|
x |
x |
|
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|
377 |
1,3,5-xxxx(2-xxxxxxxxxxxx)xxxxxxxxx-1,3,5-xxxxxxx (XXX) |
XX |
225-208-0 |
4719-04-4 |
|
|
|
|
|
x |
|
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|
x |
x |
x |
|
|
|
|
|
382 |
1,3,4,6-tetrakis(hydroxymethyl)hexahydroimidazo[4,5-d]imidazol-2,5-dion (TMAD) |
ES |
226-408-0 |
5395-50-6 |
|
x |
|
|
|
x |
|
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x |
x |
x |
|
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|
387 |
xxxxxxxxxxxxxxxxx (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 |
XX |
231-131-3 |
7440-22-4 |
|
x |
|
x |
x |
|
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|
x |
|
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|
403 |
xxx |
XX |
231-159-6 |
7440-50-8 |
|
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|
x |
|
405 |
oxid xxxxxxxx |
XX |
231-195-2 |
7446-09-5 |
|
|
|
x |
|
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|
424 |
xxxxxx xxxxx |
XX |
231-599-9 |
7647-15-6 |
|
x |
|
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|
x |
x |
|
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|
432 |
xxxxxxxx xxxxx |
IT |
231-668-3 |
7681-52-9 |
x |
x |
x |
x |
x |
|
|
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x |
x |
|
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|
434 |
xxxxxxxxxxxx |
XX |
231-711-6 |
7696-12-0 |
|
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x |
|
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|
439 |
xxxxxxx xxxxxx |
XX |
231-765-0 |
7722-84-1 |
x |
x |
x |
x |
x |
x |
|
|
|
|
x |
x |
|
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|
|
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|
444 |
7x-xxxxxxxxxxxx-1X,3X,5X-xxxxxxx[3,4-x]xxxxxx (EDHO) |
XX |
231-810-4 |
7747-35-5 |
|
|
|
|
|
x |
|
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|
x |
|
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|
450 |
dusičnan stříbrný |
SE |
231-853-9 |
7761-88-8 |
x |
|
|
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|
453 |
xxxxxxxxxxxxx xxxxx |
XX |
231-892-1 |
7775-27-1 |
|
|
|
x |
|
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|
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|
|
455 |
xxxxxxxx xxxxxxxx |
IT |
231-908-7 |
7778-54-3 |
|
x |
x |
x |
x |
|
|
|
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|
x |
|
|
|
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|
|
457 |
chlor |
XX |
231-959-5 |
7782-50-5 |
|
x |
|
|
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 pyrethroidy |
XX |
232-319-8 |
8003-34-7 |
|
|
|
|
|
|
|
|
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|
|
|
|
x |
x |
|
|
491 |
xxxx chloričitý |
XX |
233-162-8 |
10049-04-4 |
|
x |
x |
x |
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
494 |
2,2-dibrom-2-kyanacetamid (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 |
SE |
235-183-8 |
12124-97-9 |
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
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 |
|
|
|
|
|
x |
|
|
|
|
x |
|
|
|
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|
|
|
526 |
xxxxxx-xxxxxxx-2-xxxx |
XX |
237-243-9 |
13707-65-8 |
|
|
|
|
|
x |
|
|
x |
x |
|
|
x |
|
|
|
|
|
529 |
xxxxxxxxxxxxxxx |
XX |
237-601-4 |
13863-41-7 |
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
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|
|
531 |
(xxxxxxxxx)xxxxxxxx |
UK |
238-588-8 |
14548-60-8 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
534 |
xxx(1-xxxxxxxxxxxxxx-2(1X)-xxxxxxxx-X,X)xxxxxxx xxxxxxx (xxxxxxxxx mědi) |
XX |
238-984-0 |
14915-37-8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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) (XXXX) |
PT |
242-354-0 |
18472-51-0 |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
554 |
4-[(xxxxxxxxxxx)xxxxxxxx]-1-xxxxxxxxxxxx |
UK |
243-468-3 |
20018-09-1 |
|
|
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|
|
559 |
[(xxxxxxxxxxxx-2-xx)xxxxxxxx]xxxxxx-xxxxxxxxxx (XXXXX) |
X |
244-445-0 |
21564-17-0 |
|
|
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
|
|
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) |
XX |
245-387-9 |
23031-36-9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
563 |
kalium-(E,E)-hexa-2,4-dienoát (xxxxxx xxxxxxxx) |
XX |
246-376-1 |
24634-61-5 |
|
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
|
566 |
α, α′,α′′-xxxxxxxxxxxxxxxxxx-1,3,5-xxxxxxx-1,3,5-xxxxxxxxxx (XXX) |
XX |
246-764-0 |
25254-50-6 |
|
x |
|
|
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
571 |
2-xxxxxxxxxxxxxxxxxxxxxxxxx-3-xx (XXX) |
XX |
247-761-7 |
26530-20-1 |
|
|
|
|
|
x |
x |
|
x |
x |
x |
|
x |
|
|
|
|
|
577 |
xxxxxxxx(xxxxxxxxx)[3-(xxxxxxxxxxxxxxx)xxxxxx]xxxxxxx-xxxxxxx |
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-xxxxxxxxxxxxxx)-1,1-xxxxxxxxxxxxxxxx/xxxxxxxxxxx |
DE |
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
599 |
X-[(6-xxxxx-2-xxxxxxxxxx[4,5-x]xxxxxxx-3(2X)-xx)xxxxxx]-X,X-xxxxxxxx-xxxxxxxxxxxxx (xxxxxxxxxxx) |
XX |
252-626-0 |
35575-96-3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
600 |
2-xxxx-2-(xxxxxxxxxx)xxxxxxxxxxxxxx (XXXXX) |
XX |
252-681-0 |
35691-65-7 |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
961 |
xxxx vápenato-hořečnatý/dolomitické xxxxx |
XX |
253-425-0 |
37247-91-9 |
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
962 |
xxxxxxxx xxxxxxxx-xxxxxxxxx/xxxxxxxxxxx dolomitické xxxxx |
XX |
254-454-1 |
39445-23-3 |
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x |
x |
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606 |
[(3-xxxxxxxxxxx)xxxxxxxxxx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (xxxxxxxxxxx) |
EL |
254-484-5 |
39515-40-7 |
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x |
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608 |
dimethyl(tetradecyl)[3-(trimethoxysilyl)propyl]amonium-chlorid |
XX |
255-451-8 |
41591-87-1 |
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x |
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609 |
xxx- x xxxxx-x-xxxxxxx-3,8-xxxx (směs) (xxxxxxxxxx) |
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 (xxxxxxxxxx) |
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) |
XX |
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 |
alkyltrimethylammoniumchlorid xxxxxxxxxx xxxxx (XXXXX/XXXX) |
IT |
263-038-9 |
61789-18-2 |
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x |
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648 |
4,5-xxxxxxx-2-xxxxxxxxxxxxxxx-3(2X)-xx (4,5-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 (xxxxxxxxxxx) |
IT |
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-fenoxy-4-fluorfenyl)kyanmethyl]-3-(2,2-dichlorvinyl)-2,2-dimethylcyklopropan-1-karboxylát (cyfluthrin) |
XX |
269-855-7 |
68359-37-5 |
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x |
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667 |
xxxxx(X12-18)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXX (C12-18)) |
XX |
269-919-4 |
68391-01-5 |
x |
x |
x |
x |
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x |
x |
x |
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x |
671 |
alkyl(C12-16)dimethylbenzylammoniumchlorid (XXXXX/XXX (X12-X16)) |
XX |
270-325-2 |
68424-85-1 |
x |
x |
x |
x |
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x |
x |
x |
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x |
673 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxxx (XXXX) (C8-10) |
IT |
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) |
MT |
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 |
alkyl(C10-C16)dimethylaminoxidy |
XX |
274-687-2 |
70592-80-2 |
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x |
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693 |
xxx(xxxxxxxxxxx)-xxx(xxxxx) xxxxxxxxxxxxx |
XX |
274-778-7 |
70693-62-8 |
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x |
x |
x |
x |
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701 |
xxxxxxxxx-xxxxxxxxxxxxxxxx xxxxxxxxxx (XXXX) |
XX |
279-013-0 |
84665-66-7 |
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x |
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1015 |
margosa, Xxxxxxxxxxx xxxxxx, xxxxxxx |
XX |
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 stračkolistá, Chrysanthemum xxxxxxxxxxxxxxxx, výtažek |
ES |
289-699-3 |
89997-63-7 |
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x |
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744 |
levandule xxxxxx, Xxxxxxxxx xxxxxxx, výtažek/levandulový xxxx |
XX |
294-470-6 |
91722-69-9 |
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x |
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776 |
1-[3,5-xxxxxxx-4-(1,1,2,2-xxxxxxxxxxxxxxxx)xxxxx]-3-(2,6-xxxxxxxxxxxxxx)xxxxxxxx (hexaflumuron) |
XX |
401-400-1 |
86479-06-3 |
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x |
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779 |
xxxxxxx produkty xxxxxxxxx xxxxxxxx a X-xxxxx(X12-X14)xxxxxx-1,2-xxxxxxx (xxxxxxxxxxxxx) |
XX |
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 (BBIT) |
XX |
420-590-7 |
4299-07-4 |
|
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x |
x |
|
x |
x |
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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) |
DK |
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, xxxx XXXX-1743 |
XX |
xxxxxxxxxxxxxxx |
143447-72-7 |
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x |
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955 |
Bacillus xxxxxxxxxxxxx xxxxx. israelensis, xxxx XX3X |
XX |
mikroorganismus |
xxxx xxxxxxxxxx |
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x |
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957 |
Bacillus xxxxxxxx |
XX |
xxxxxxxxxxxxxxx |
xxxx relevantní |
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x |
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928 |
5-chlor-2-methylisothiazol-3(2H)-on (Xxxxxx 247-500-7) a 2-xxxxxxxxxxxxxxxx-3(2X)-xx (Xxxxxx 220-239-6), xxxx (3:1) (xxxx XXXX/XXX) |
XX |
xxxx |
55965-84-9 |
|
x |
|
x |
|
x |
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x |
x |
x |
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939 |
xxxxxxx xxxxx (xxxxxxxx reakcí xxxxxxxx xxxxxxx a 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 zeolit |
XX |
xxxx xxxxxxxxxx |
není xxxxxxxxxx |
|
x |
|
x |
x |
|
x |
|
x |
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|
849 |
3-xxxxxxxxxxxx-(1X,3XX)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxxxxxx) |
XX |
xxxx relevantní |
188023-86-1 |
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x |
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931 |
xxxxxxxxxxxxxxxxxxxxxxx, X-X12-14(xx xxxxx xxxxxx), xxxxxxxx xxxxxx s xxxxxxxxxxxx xxxxxxxxx (Xxxxxxxx 20) |
XX |
xxxx xxxxxxxxxx |
139734-65-9 |
|
x |
x |
x |
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|
152 |
xxxxxxxx xxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-ethyl-5-methylhydantoinu x xxxxxx x xxxxxxx (XXXXX) |
XX |
xxxx x xxxxxxxxx |
xxxx x xxxxxxxxx |
|
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x |
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459 |
reakční xxxx xxxxx titaničitého x chloridu xxxxxxxxxx |
XX |
xxxx x xxxxxxxxx |
xxxx x xxxxxxxxx |
x |
x |
|
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|
x |
x |
|
x |
x |
x |
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|
777 |
xxxxxxx xxxxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-ethyl-5-methylhydantoinu s chlorem (XXXXX) |
XX |
xxxx x xxxxxxxxx |
není k dispozici |
|
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x |
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810 |
xxxxxxxxxxxxxx xxxx s obsahem xxxxxxx |
XX |
xxxx x xxxxxxxxx |
308069-39-8 |
|
x |
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x |
|
x |
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824 |
xxxxxxxx-xxxxxxxxx zeolit |
XX |
není x xxxxxxxxx |
130328-20-0 |
|
x |
|
x |
x |
|
x |
|
x |
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1013 |
xxxxxxxx-xxxxxxx xxxxxx |
XX |
není x xxxxxxxxx |
130328-19-7 |
|
x |
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x |
x |
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x |
|
x |
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1017 |
xxxxxxx xxxxxxxxxxx xx oxidu xxxxxxxxxx (jako xxxxxxxxxxxx xx xxxxx xxxxxxxxxx xxxxxxxx x primárními xxxxxxxxx xx xxxxxxxxxx) |
SE |
xxxx k dispozici |
není x xxxxxxxxx |
|
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x |
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1019 |
xxxx xxxxxxxxx (jako xxxxxxxxxxxx tvořený xxxxxxxx x xxxxxxxxxx) |
XX |
xxxx x xxxxxxxxx |
68909-20-6 |
|
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x |
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831 |
xxxxxxxxx |
XX |
přípravek 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 (xxxx 4 izomerů 1X xxxxx, 1X: 1R xxxxx, 1S: 1R xxx, 1X: 1X xxx, 1X 4:4:1:1) (x-xxxxxxxxx) |
XX |
xxxxxxxxx xx xxxxxxx xxxxxxx |
231937-89-6 |
|
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x |
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855 |
(XX)-3-xxxxx-2-xxxxxx-4-xxxxxxxxxxxx-2-xx-1-xx-(1X,3X)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (směs 2 xxxxxxxxxxxxx) (xxxxxxxxxx) |
XX |
xxxxxxxxx xx xxxxxxx xxxxxxx |
260359-57-7 |
|
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|
x |
|
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|
848 |
X-[(6-xxxxx-3-xxxxxxx)xxxxxx]-X′-xxxx-X-xxxxxxxxxxxxxxxxxxx (xxxxxxxxxxx) |
XX |
xxxxxxxxx xx xxxxxxx 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) |
BE |
přípravek xx xxxxxxx xxxxxxx |
67375-30-8 |
|
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x |
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843 |
4-xxxx-2-(4-xxxxxxxxxx)-1-(xxxxxxxxxxxx)-5-(xxxxxxxxxxxxxx)xxxxxx-3-xxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
xxxxxxxxx xx ochranu 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 chlorid xxxxxx (XX Xxxxxxx) |
HU |
xxxxxxx |
25988-97-0 |
|
x |
|
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|
x |
|
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|
863 |
xxxx(xxxxxxxx-1,5-xxxxxxxxx-1,6-xxxx) (XXXX) |
XX |
xxxxxxx |
27083-27-8/32289-58-0 |
x |
x |
x |
x |
x |
x |
|
|
x |
|
x |
|
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|
868 |
xxxx(xxxxxxxx-1,5-xxxxxxxxx-1,6-xxxx-xxxxxxxxxxxx) |
FR |
polymer |
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) |
IT |
polymer |
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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XXXX 2
Xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxxxxxx xx xxx 4. xxxxx 2014
Xxxx xxxx xxxx xxxxxxx xxxxxxxx
— |
xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxx x xxxxxxx níže, xxxxxx případných xxxxxxxxx, |
— |
xxxxxxxx xxxxxxxxx všech xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx x xxxxxxx x xxxxx 1, xxxxx xxxx, xxxxx xxxx xxxxxxx x xxxxxxx, x |
— |
xxxxxxxx xxxxxxxxx všech xxxxxxxxx xxxxxxxx xxxxx x xxxx xxxxxxxxx schválených xx 4. srpna 2014, x xxxxxxxx těch, které xxxx výslovně xxxxxxxxx. |
Kombinace xxxxx a typu přípravku x xxxxxxxxxxxxx xxxxxxxx xx této xxxxx xxxxx předmětem rozhodnutí x xxxxxxxxxxx xxxxx xxxxxx 20, jestliže xxxxx osoba xxxxxx xxxxxxxx xx xxxxxxxx xxxxxx xx vstupu xxxxxx xxxxxxxx v platnost podle xx. 14 odst. 3 xxxx xxxxx je takové xxxxxxxx xxxxxxxxx xxxxx xx. 17 odst. 4 xxxx 5.
Xxxxx xxxxxxx |
Xxxxx xxxxx |
Xxxxxxx xxxx zpravodaj |
Xxxxx ES |
Xxxxx XXX |
1 |
2 |
3 |
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17 |
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21 |
22 |
1021 |
1,3-xxxxxxx-5,5-xxxxxxxxxxxxxxxxx (nově definovaný xxxxx položky 152) |
XX |
204-258-7 |
118-52-5 |
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x |
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166 |
xxxxxx(xxxxxxxxx)xxxxxxxxxxxxxxx-xxxxxxx (xxx položka 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 |
xxxxxx(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxxx (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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331 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxx (viz položka 949) |
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219-234-1 |
2390-68-3 |
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384 |
xxxxxxxx(xxxxxxx)xxxxxxx-xxxxxxx (xxx xxxxxxx 949) |
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226-901-0 |
5538-94-3 |
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399 |
xxxxxx(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxx (xxx xxxxxxx 948) |
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230-698-4 |
7281-04-1 |
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401 |
xxxxxxx |
XX |
231-131-3 |
7440-22-4 |
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418 |
xxxx xxxxxxxxx xxxxxxx |
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 |
x |
x |
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x |
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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 (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 (xxx 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) |
XX |
258-067-9 |
52645-53-1 |
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637 |
xxxxx(xxxxxx)xxxxxxxxxxxxxxx-xxxxxxxx (xxxxx xxxxxxx od xxxxxxxx kyselin 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 (alkyl 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 |
xxxxxxx(X6-X12)xxxxxxxxxxxxxxx-xxxxxxxx (xxx xxxxxxx 949) |
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269-925-7 |
68391-06-0 |
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670 |
xxxxx(X8-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxx xxxxxxx 948) |
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270-324-7 |
68424-84-0 |
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689 |
xxxxx(X10-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxx 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 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 margosy xxxx xxx z xxxxx xxxxxxxx Xxxxxxxxxxx indica xxxxxxxxxxx xxxxx x xxxx zpracovaný xxxxxxxxxxx xxxxxxxxxxxx |
XX |
283-644-7 |
84696-25-3 |
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x |
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741 |
xxxxx(X8-X18)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxx (xxx 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 xxxxxxx 777) |
XX |
401-570-7 |
89415-87-2 |
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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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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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xxxx |
8001-54-5 |
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949 |
(dialkyl)dimethylamonium-chloridy, -xxxxxxx xxxx -xxxxxx-xxxxxxx) (xxxxxx (X6-X18) xxxxxxxx a xxxxxxxxxx, xxxxxxxx od xxxxxxxx xxxxxxx xxxx, xxxxxxxxxx xxxxx x xxxxxxxx xxxxx) (DDAC) |
XX |
směs xxxxx xxxxxxxxx x xxxxxxx EINECS |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
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x |
x |
x |
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950 |
alkyltrimethylamonium-chloridy, -xxxxxxx xxxx -methyl-sulfáty) (xxxxxx (X8-X18) xxxxxxxx x xxxxxxxxxx, xxxxxxxx xx xxxxxxxx xxxxxxx xxxx, xxxxxxxxxx xxxxx x xxxxxxxx oleje) (XXXX) |
XX |
xxxx látek xxxxxxxxx x xxxxxxx XXXXXX |
xxxx xxxxxxxxxx |
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x |
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948 |
xxxxxx(xxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx nebo -xxxxxxxxx) (xxxxxx (X8-X22) xxxxxxxx x nenasycené, xxxxxxxx xx mastných xxxxxxx xxxx, xxxxxxxxxx xxxxx x xxxxxxxx xxxxx) (XXX) |
XX |
xxxx xxxxx uvedených x xxxxxxx EINECS |
není xxxxxxxxxx |
x |
x |
x |
x |
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x |
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x |
x |
x |
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849 |
3-xxxxxxxxxxxx-(1X,3XX)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxxxxxx) |
IE |
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 xxxxxxxxxx |
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 xxxxx spadající xxx položku 667) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
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1003 |
xxxxx(X12-X18)(xxxxxxxxxxx)xxxxxxxxxxxxxxx- xxxxxxxx (xxxx xxx látka xxxxxxxxx xxx xxxxxxx 725) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
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1005 |
xxxxx(X12-X14)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxx než látka xxxxxxxxx xxx xxxxxxx 724) |
XX |
xxxx relevantní |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
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1006 |
fosforečnanové xxxx obsahující stříbro, xxxxx, hliník a 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 látka spadající 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 |
xxxxx(xxxxxxxxx)xxxxxxx-xxxxxxxx (xxxxx xxxxxxx xx mastných xxxxxxx xxxxxxxxxx xxxxx) (xxxx xxx látka xxxxxxxxx xxx xxxxxxx 635) |
XX |
xxxx relevantní |
xxxx xxxxxxxxxx |
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x |
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1012 |
hlinitokřemičitan xxxxx, stříbrný x xxxxxxxxx komplex/stříbrno-zinečnatý xxxxxx |
XX |
není xxxxxxxxxx |
130328-20-0 |
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x |
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x |
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x |
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598 |
(±)-1-(β-xxxxxxxx-2,4-xxxxxxxxxxxxxxxxx)xxxxxxxx (xxxxxxxx xxxxxxxxx) |
XX |
xxxxxxxxx xx ochranu rostlin |
73790-28-0 |
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x |
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XXXXXXX XXX
Xxxxx
Xxxx přípravků |
Xxxxx xxx xxxxxxxxxx hodnotící xxxxxx xxxxx čl. 6 xxxx. 3 xxxx. x) |
Xxxxx pro 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 x 2 |
31.12.2018 |
31.3.2019 |
6 x 13 |
31.12.2019 |
31.3.2020 |
7, 9 a 10 |
31.12.2020 |
31.3.2021 |
11, 12, 15, 17, 20 a 22 |
31.12.2022 |
31.9.2023 |