XXXXXXXX XXXXXX X XXXXXXXXX XXXXXXXXX (XX) x. 1062/2014
xx xxx 4. xxxxx 2014,
týkající xx xxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxx x xxxxxxxxxx xxxxxxxxxxx, xxxxx xxxx uvedeny x xxxxxxxx Evropského xxxxxxxxxx x Xxxx (XX) x. 528/2012
(Xxxx x xxxxxxxx xxx XXX)
XXXXXXXX XXXXXX,
x xxxxxxx xx Xxxxxxx x xxxxxxxxx Evropské xxxx,
x ohledem na xxxxxxxx Evropského xxxxxxxxxx x Xxxx (EU) x. 528/2012 xx xxx 22. xxxxxx 2012 o xxxxxxxx xxxxxxxxxx přípravků na xxx a xxxxxx xxxxxxxxx (1), x xxxxxxx xx xx. 89 xxxx. 1 xxxxx xxxxxxxxxxx xxxxxxxxx nařízení,
xxxxxxxx x těmto xxxxxxx:
(1) |
Xxxxxxxx Xxxxxx (XX) x. 1451/2007 (2) xxxxxxx xxxxxxxxx pravidla xxx program xxxxxxxx xxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx (dále xxx „xxxxxxx přezkumu“), který xxx xxxxxxx x xxxxxxx x xx. 16 xxxx. 2 směrnice Xxxxxxxxxx parlamentu x Xxxx 98/8/XX (3). Xxxxxxx tato xxxxxxxx xxxx xxxxxxx x xxxxxxxxx nařízením (EU) x. 528/2012, měla xx xxx prováděcí xxxxxxxx xxx pokračování xxxxxxxx xxxxxxxx xxxxxxxxxxxx ustanovením xxxxxxxxx xxxxxxxx. |
(2) |
Xx důležité xxxxx xxxxxxxxx účinné xxxxx x typu xxxxxxxxx, které xxxxx xxx dodávány xx xxx x xxxxxxxxx podle přechodných xxxxxxxxxx xxxxxx 89 nařízení (XX) x. 528/2012 x xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx. Mělo xx xxxx xxx x x xxxxxxx xxxxxxxxx xxxxxx xxxxx x xxxx přípravku, xxxxx jsou xxxxxxxxx x programu xxxxxxxx. |
(3) |
Pokud xxxxxxxxx xxxxxxxx odchylky xxx xxxxxxxxx x xxxxxx xxxxx xxxxxx 6 xxxxxxxx (ES) x. 1451/2007, xxx xxxxxxxxxx se xx něj xxxxxxx xxx xxxxxxxxx x xxxxxx xxxxxxx x xx. 2 xxxx. 5 xxxx. x) nařízení (EU) x. 528/2012, xxxx by xxx xxxxxx xxxxx, xxxxx obsahuje, xxxxxxxxx x xxxxxxxx xxxxxxxx pro xxxxxxxxx typ xxxxxxxxx. X xxxxxxxx vnitrostátních xxxxxxxx xx xxxx být xxxxxx dodávání xx xxx x xxxxxxxxx xxxxxxxx xx xx xxxxxxxx xxxxxxxxx xxxxxxxxx. Xxxxxx xxxxxxxxxxx prohlášení xx xxx xxxxxxx, xxxxx xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxx. Xxxxx xx mělo xxxxxx x xxxxxxxxx, xxx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx x xxxx definice xxxx xxxxxxxxx v nařízení (XX) x. 528/2012 xxxxxx xxxxxxxx xxxxxxx ve xxxxxxxx 98/8/XX xxxx xx řádně odůvodněno xxxxxxxxxxx Xxxxxx xxxxxxxx x xxxxxxx s čl. 3 odst. 3 xxxxxxxx (EU) č. 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 přípravek xxxxxxxx účinnou látku, xxxxx xxx není xxxxxxxx xx xxxxxxxx xxxxxxxx, x xxxx xxxxx xxxxxxx nebo xx z xx xxxxxx, xxxxx xxxxxxxx xx používání tohoto xxxxxxxxxx přípravku x xxxxxxxx xxxxx xxxxxxxx, mělo xx xxx v tomto xxxxxxxx státě použití x xxxxxxxx na trh xxxxxxxx na jeho xxxxxxxxxxxx, xx xxxxxxxx xxxxxxxx x xx xxxxxxxx xxxx. |
(5) |
X zájmu xxxxxxxxxxx x xxxxxxxxxxxx by měl xxx postup xxxxxxxxx xxxxxxxx xxxxx x xxxxxxxx xxxxxxxx xx xxxxx xxxxxxxxxx xxxxxxx xxxxxxx x xxxxxxxx xxxxxxxxxx xxx xxxxxxx předložené xxxxx xxxxxx 7 nařízení (XX) x. 528/2012 xxxx xxxxx xxxxxxxxxxx xxxxxxxx Xxxxxx (EU) č. 88/2014 (5). |
(6) |
Pro xxxxx, které xxxxxxx xxxxxxxx xxxxxxxxx xxxx xxxxxxxx xxx xxxxxxx, xx měl xxxxxxxxx xxxxxxxxx orgán xxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxxxxx x xxxxxxxx xxxxx xxxxx čl. 37 odst. 1 xxxxxxxx Evropského parlamentu x Xxxx (XX) x. 1272/2008 (6), xxxxx xxx o xxxxxxxxx vlastnosti vzbuzující xxxxx, a zároveň xx xxxx být xxxxxxxxx xxxxx xxxxxxxxx státu xxxxxxxxx xxxxx xxxxxxxx xx xxxxxx xxxx xxxxx xxxxxxxxxxx xxxxxxxxxx. Xxxxxxxxx xxxxxxxxx xxxxx xx xxx xxxx xxxxxxxxxxx xxxxxxxx v xxxxxxx xxxxx, které xx xxxxxxxxx kritéria xxx xxxxx xxxxxxxxxxxx, xxxxxxxxxxxxxxx xx xxxxxxx, nebo xxxxx, xxxxx xx xxxxx xxx považovány xx xxxxx x xxxxxxxxxxx xxxxxxxxxxxxxx xxxxxxxx endokrinní xxxxxxxx. |
(7) |
Xxx xxxx xxxxxxxxx, xx xxxxxxx přezkumu 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 x xxxx xxxxxxxxx, x nichž xxxx příslušné xxxxx xxxxxxxxxx xx xxxxxxx xxxxxxxxxxx x xxxxxxxx (XX) x. 1451/2007 xxxx v tomto xxxxxxxx. Xxxxx xxxx xx xx xxxx xxxxxxxx xxxxxx xxxxx xxx xxxxxxxxx xxxxxxxxx, přičemž xx xx xxxx xxxx x xxxxx xxxxxxx, xx žádosti xx xxxxx xxx xxxxxxxxx méně xxx xxx xxxx xxxxxxxxx xxxxxx lhůt. |
(8) |
Xxxxxxx xxxxxxxx xx xxxxxxx I xxxxxxxxx 7 xxxxxxxx (XX) x. 528/2012 xxxxx xxxxxx xxxxxxxxx xxxxx xxxxxxxxx na xxxxx. Xx proto xxxxxx x xxxx xxxx xxxxxx žádosti x xxxxxxxx xx xxxxxxx xxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6. |
(9) |
Xxx xxxxxx na čl. 90 odst. 2 xxxxxxxx (XX) x. 528/2012 xxxxxxx x xxxxxx 91 xxxxxxxxx xxxxxxxx, xx xxxxxxxx uvedená v článku 10 xxxxxxxxx xxxxxxxx xx xxxx být relevantní xxx následné xxxxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxxxx xxxxxxxxx. Xx xxxxx xxxxxx určit xxxxx xxxxxxxxx tato kritéria xx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx. |
(10) |
Xxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xx xxx xxx xxxxxxx se xx xxxxxxxx dohodě xxxxxxxx ke xxxxxxxxxxx xxxxxxxxxxx nebo xxx xxxxxxxx za xxxxxxxxxxx, xx xxxxx tomu xxxxxxx ke xxxxxxxx xxxxxxxxx x xxxxxx xxxxxxxxx xxxxxxxx k xxxxxx, xxxxxxx jinak xx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx xxxxx znovu. |
(11) |
Xxxxxxx xx xxxxx v programu xxxxxxxx xxxxxxxxxx, mělo xx xxx xxxxxxxxxx xxxxxxxx od ní xxxxxxxxx. Pokud k xxxx dojde, xxxx xx xxx potenciální xxxxxxxxx xxxxxxx převzít xxxxxxx, nebylo-li xxxx xxxxxxxx využito xxx xxxxxx, xxxxx xxx xxxxxxx ke zpoždění xxxxxxxx xxxxxxxx, x xxxxxxxx-xx xxxxxxxx již xxxxxxxx xx svém xxxxxxxxxx. |
(12) |
Xxxxx se při xxxxxxxxx xxxxxx xxxxx xxxxx, že identita oficiálně xxxxxxxx do programu xxxxxxxx xxxxxx neodpovídá xxxxxxxx xxxxxxxx xxxxxxxxx xxxxx, x x hodnocení xxxxx xxxxxxx závěry ohledně xxxxxxxx oficiálně xxxxxxxx xxxxx, xxxx xx xxx xxxxx xxxx xxxxx x xxxxxxx xxxxxxxxx xxxxx xxxxxxxxx x xxxxxxx xxxxx xxxxxx, xxx xxxxxxxx podporu této xxxxxxxxx xxxxxxxx xxxxx. |
(13) |
Xxxxxxx xxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx nejsou x xxxx přijetí xxxxxx nařízení podporovány xxxxxx xxxxxxxxxx. Xxxxx xx xxxx určitých xxxxxxxxxxxxx, xxxxxx podle xx. 4 xxxx. 4 xxxxxxxx (XX) x. 528/2012 xxxx xxxxxxxxx xxxxx schválit, xxxxx xxx xxxx xxxxxxxx xxxxxxxxx. X xxxxxxxxx xxxxx x xxxxxxxxxxxxx xx měly xxx xxxxx možnost xxxxxxx xxxxx, xxxxxxx xxxxx xx xxxx xxxxx x xxxxxxxxxxxxx xxxxxx xxx x xxxxxxxx xxxxxxxx xxxxxxxxx. |
(14) |
Xxx xxxx xxxxxxxxx, xx xxxxx xxxxx nezůstane v xxxxxxxx xxxxxxxxxxx xxx xx něj xxxxxx xxxxxxxx, xxxx by xxxxxxxx byla vyhodnocena, xxxx by xxxxxxxx xxxxx, xxxxx xxxxx xxxxxx xxxxxxxxx, x xxxxxxxx xxxx její xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxx x xx, |
XXXXXXX XXXX XXXXXXXX:
XXXXXXXX 1
XXXXXXX X XXXXXXXX
Xxxxxx 1
Předmět
Toto xxxxxxxx xxxxxxx xxxxxxxx xxx xxxxxxxxx pracovního xxxxxxxx xxxxxxxxxxxxxx přezkumu xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx v článku 89 xxxxxxxx (XX) č. 528/2012.
Xxxxxx 2
Xxxxxxxx
Pro xxxxx xxxxxx xxxxxxxx se xxxxxxx tyto xxxxxxxx:
x) |
„xxxxxxxxxxx x xxxxxxxxxxx“ xx xxxxxx rozhodnutí xxxxxxxxxx xxxxxxxxx látky x xxxx xxxxxxxxx xxxxx čl. 9 xxxx. 1 xxxx. x) xxxxxxxx (XX) č. 528/2012 xxxx xx. 89 xxxx. 1 xxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx, xxxx xxxxxxxxx nezařadit xx xxxxxxx X xxxx XX xxxxxxxx 98/8/XX; |
x) |
„xxxxxxxxx látky x xxxx přípravku xxxxxxxxx xx xxxxxxxx přezkumu“ xx xxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx uvedená x xxxxxxx II, která xxxxxxx xxxx xxxxxxxx:
|
x) |
„xxxxxxxxxx“ xx xxxxxx xxxxx, která xxxxxxxxxx xxxxxx x xxxxxxxxx xxxxx x xxxx xxxxxxxxx zařazené xx xxxxxxxx xxxxxxxx xxxx xxxxxxxxxx xxxxxxxx, xxxxx xxxxxxxx xxxxxxxxxx xxxxx xx. 17 xxxx. 5 tohoto nařízení, xxxx jejímž xxxxxx xxxx tato žádost xxxx oznámení xxxxxxxxxx; |
x) |
„xxxxxxxxxx xxxxxxxxxx orgánem“ xx xxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx uvedeného x xxxxxxx XX xxxxxx xxxxxxxx, určený x xxxxxxx s článkem 81 xxxxxxxx (XX) x. 528/2012. |
XXXXXXXX 2
XXXXXX HODNOCENÍ XXXXXXXXXXX
Xxxxxx 3
Xxxxxx x xxxxxxxxx xxxx xxxxxxxx xx přílohy X xxxxxxxx (XX) x. 528/2012
1.&xxxx;&xxxx;&xxxx;Xxxxxx o schválení či xxxxxxxx do přílohy X&xxxx;xxxxxxxx (XX) x.&xxxx;528/2012 xxxx xxxxx pouze xxxxxxxx, x jehož xxxxxxxx xxxxx agentura k xxxxxx, xx xxxxxxxx xxxxxxxxxx xxxxx xx.&xxxx;17 xxxx.&xxxx;5 xxxxxx xxxxxxxx.
Xxxxx xx xxxxxx týká xxxxxxxx xx&xxxx;xxxxxxx I nařízení (XX) x.&xxxx;528/2012, může xx xxxxx pouze xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx xxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxxxxx x&xxxx;xxxxxxxx 1 xx podávají xxxxxxxx do dvou xxx xx xxxxxxxxxx o souladu x požadavky xxxxx xx.&xxxx;17 odst. 5.
Xxxxxx 4
Xxxxxxx xxxxxxx
1. Agentura xxxxxxxxx účastníka x xxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx Komise (XX) č. 564/2013 (7) x zamítne xxxxxx, xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx ve xxxxx 30 dnů. O xxxx skutečnosti informuje xxxxxxxxx x xxxxxxxxx xxxxxxxxx xxxxx.
2. Xx obdržení xxxxxxxx splatných xxxxx xxxxxxxxxxx xxxxxxxx (EU) x. 564/2013 xxxxxx xxxxxxxx xxxxxx a informuje x xxx xxxxxxxxx x xxxxxxxxx xxxxxxxxx xxxxx, xxxxxxx xxxxx xxxxx xxxxxxx xxxxxxx a její xxxxxxxxx xxxxxxxxxxxxx xxx.
3. Proti xxxxxxxxxxx xxxxxxxx podle xxxxxxxx 1 xxxxxx xxxxxx xxx xxxxx xxxxxxx prostředek v xxxxxxx x článkem 77 xxxxxxxx (XX) x. 528/2012.
4. Xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx účastníka x xxxxxxxx splatném xxxxx xx. 80 xxxx. 2 xxxxxxxx (XX) x. 528/2012 xx 30 xxx xxxx, co agentura xxxxxxx xxxxxx, x xxxxxxx žádost, xxxxx xxxxxxxx nezaplatí xxxxxxxx xx xxxxx 30 xxx. X xxxx xxxxxxxxxxx informuje xxxxxxxxx x xxxxxxxx.
Xxxxxx 5
Xxxxxxxxx xxxxxxx x xxxxxxxxx nebo xxxxxxxx xx xxxxxxxxx 6 xxxxxxx I xxxxxxxx (EU) x. 528/2012
1. Xxxxx xxxxxxxx přijme xxxxx xx. 4 xxxx. 2 žádost x xxxxxxxxx xxxx zařazení xx xxxxxxxxx 6 xxxxxxx X xxxxxxxx (XX) x. 528/2012, xxxxx obsahuje xxxxx xxxxxxxxxx x xxxxxxx s čl. 6 xxxx. 1 x 2 xxxxxxxxx nařízení, a byl xxxxxxxx xxxxxxxx xxxxx xx. 4 xxxx. 4, xxxxxxxxx xxxxxxxxx orgán žádost xxxxxxx xx 30 dnů xx xxxxxxxxx poplatků.
2. Pokud xxxxxxxxx xxxxxxxxx xxxxx xxxxxxx xx xxxxxxxxx dokumentaci xxxxx nařízení (XX) x. 1451/2007, xxxxx ta xxxxx nebyla xxxxxx xxxx xxxxx xxxxx xxxxxx 13 xxxxxxxxx xxxxxxxx, xxxxxxx xxxxxxxxx xxxxxxxxx orgán xxxxxx xxxxxxxxxx xx 3. ledna 2015.
3. X xxxxxxxxx xxxxxxxxx x odstavcích 1 x 2 hodnotící xxxxxxxxx xxxxx neprovádí xxxxxxxxx xxxxxxx ani xxxxxxxxxxxx předložených xxxxx xxxx odůvodnění.
4. Xxxxx xxxxxxxxx xxxxxxxxx orgán xxxxxx, xx xxxxxx xx xxxxxxx, sdělí xxxxxxxxxxx, xxxx xxxxxxxxxx informace xxxx k xxxxxxxxx xxxxxxx nutné, a x xxxxxxxxxx těchto xxxxxxxxx xxxxxxx přiměřenou xxxxx. Tato lhůta xxxxx xxxxxxxxxx 90 xxx.
Xxxxxxxx-xx xxxxxxxxx xxxxxxxxx xxxxx, xx xxxxxxxxxx doplňující xxxxxxxxx xxxxxxxxx xx xxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxx 2, xxxxxxx xxxxxx xx 30 xxx xx xxxxxxxx xxxxxxxxxxxx xxxxxxxxx.
Jestliže xxxxxxxx xxxxxxxxxx informace xx xxxxxxxxx lhůtě xxxxxxxxxx, xxxxxxxxx xxxxxxxxx xxxxx xxxxxx zamítne x informuje x xxxx skutečnosti účastníka x agenturu. X xxxxxx případech xx xxxxx xxxxxxxx zaplacené x xxxxxxx s čl. 80 xxxx. 1 x 2 xxxxxxxx (EU) x. 528/2012.
Xxx potvrzení xxxxxxx xxxxxxxxx xxxxxxxxx orgán xxxxxxxxxx xxxxxxxxx účastníka, xxxxxxxx x xxxxx xxxxxxxxx xxxxxx x xxxxx xxxxx xxxxxx xxxxxxxxx.
Xxxxxx 6
Hodnocení žádostí
1. Tento xxxxxx se xxxxxxx, xxxxx platí některá x xxxxxx podmínek:
x) |
xx-xx žádost xxxxxxxxx xxxxx xxxxxx 5; |
x) |
xxxxx xxxxxxxxx příslušný xxxxx xxxxx xxxxxxxxxxx xxxx xxxxxx xxxxx xxxxxx 13 nařízení (XX) x. 1451/2007, xxx xxxxx xxxxxxxxxxx Xxxxxx zprávu xxxxxxxxxxx orgánu xxxxx xx. 14 xxxx. 4 xxxxxxxxx xxxxxxxx; |
x) |
xxxxx xxxxxxxx xxxxxxx xxxxxx o xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4 xxxx 5 xxxxxxx I nařízení (XX) x. 528/2012 xxxxx xx. 4 xxxx. 2 a xxx xxxxxxxx xxxxxxxx xxxxx xx. 4 xxxx. 4. |
2. Xxxxxxxxx xxxxxxxxx orgán xxxxxxxx xxxxxx podle xxxxxx 4 a 5 xxxxxxxx (EU) x. 528/2012 a xxxxxxxx xxx xxxxxxx xxxxxx xx xxxxxx xxxxxxxxx xx xxxxx předložené x xxxxxxx x xx. 6 xxxx. 3 uvedeného xxxxxxxx x zašle xxxxxxxxx xxxxxx x závěry xxxxx xxxxxxxxx agentuře.
3. Xxxxx xxxxxxx kombinaci xxxxx x xxxx přípravků xxxxxxxxx xxxxxxx účastníků, xxxxxxxxx hodnotící xxxxxxxxx xxxxx pouze xxxxx xxxxxxxxx zprávu. Xxxxxxxxx xxxxxx x xxxxxx xxxxx x xxxxx x xxxxxx xxxx, xxxxx toho, xx xxxxxxx xxxxxxx:
x) |
365 xxx po posledním xxxxxxxxx xxxxxxxx v odst. 1 xxxx. x), xxxxxx xxxxxxxx xxxxxxxx x xxxx. 1 xxxx. x) xxxx xxxxxxxxx poplatku xxxxxxxxx x xxxx. 1 písm. c) x dotyčné kombinace xxxxx a typu xxxxxxxxx; |
x) |
ve xxxxx xxxxxxxxx x xxxxxxx XXX. |
4. Xxxx tím, xxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx xxx xxxxxx xxxxxxxx, xxxxxx xxxxxxxxxxx xxxxx xx 30 xxx x hodnotící xxxxxx x x xxxxxxx hodnocení xxxxxxx xxxxxxxxxx. Xxxxxxxxx xxxxxxxxx xxxxx xxxx xxxxxxxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxx x xxxxxxxxx fázi xxxxx hodnocení.
5. Xxxxx xx xxxxx, xx jsou x hodnocení xxxxx xxxxxxxxxx xxxxxxxxx, xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx, xxx tyto xxxxxxxxx xx xxxxxxxxx xxxxx xxxxxxxxx, x xxxxxxxxx x tom xxxxxxxx.
Xxxxx 365 dnů xxxxxxx x xxxxxxxx 3 xx xxxxxxx xx dobu ode xxx xxxxxxxx požadavku xx dne xxxxxxxx xxxxxxxxx. Pokud xx xxxx xxxxxxxxxx xxxxxxx xxxxxxxxxxxx údajů xxxx xxxxxxxxxxx okolnostmi, xxxxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxx:
a) |
365 xxx x xxxxxxx, že xx xxxxxxxxxx informace xxxxxx xxxxxx, xxxxx xxxxxx xxxxxx x xxxxx xxxxxxxx 98/8/XX xxxx v rámci xxxxxxx xxxxxxxxxxx xxx xxxxxxxxxxx xxxxxxx směrnice; |
x) |
180 dní xx xxxxx ostatních případech. |
6. Xxxxx xxxxxxxxx xxxxxxxxx orgán xxxxxx, že xxxxxxxx xxxxx xxxxxxx zdraví xxxx nebo xxxxxx xxxx xxxxxxxxx xxxxxxxxx xxxxxxxxxxx x xxxxxxxxxxxxx účinků xxxxxxxxxx x xxxxxxxxx biocidních přípravků xxxxxxxxxxxx xxxxxx xxxx xxxxxxxx xxxxxx látky, xxx xxxxx xxxxxxxxxxxx x xxxxxxx x xxxxxxxxx příslušných xxxxx oddílu II xxxx 3 přílohy XX xxxxxxxx Evropského xxxxxxxxxx x Xxxx (XX) x. 1907/2006 (8) x xxxxxx xx xx svých xxxxxx.
7. X xxxxxxx xxxxxxx xx xxxxxxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xxx zbytečného xxxxxxx x xxxxxxxxxx při xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx xxxxxxxx 3:
x) |
xxxxxxxx xxxxx agentuře podle xx. 37 xxxx. 1 nařízení (XX) č. 1272/2008, xxxxxxxx xx xxxxxxx, že je xxxxxxx xxxxx x xxxxxxxx xxxxxxxxx x xx. 36 xxxx. 1 xxxxxxxxx nařízení, xxx xxxx náležitě xxxxxx x xxxxx 3 xxxxxxx XX xxxxxxxxx xxxxxxxx; |
x) |
xxxxxxxxxx x xxxxxxxxx, xxxxx xx domnívá, xx xxxxx z kritérií xx. 5 xxxx. 1 xxxx. x) nebo x) xxxxxxxx (XX) x. 528/2012 xxxx xxxxxxxx xx. 10 xxxx. 1 písm. d) xxxxxxxxx nařízení jsou xxxxxxx, xxx xxxxxx xxxxxxxx xxxxxx x xxxxxxx XXX xxxxxxxx (XX) x. 1907/2006 xxxx x xxxxxxx xxxxxxxx x xx. 59 xxxx. 1 xxxxxxxxx nařízení. |
Xxxxxx 7
Stanovisko agentury
1. Tento xxxxxx se xxxxxxx, xxxxx platí xxxxxxx x xxxxxx podmínek:
x) |
pokud xxxxxxxxx xxxxxxxxx orgán xxxxxxxxx xxxxxxxxx xxxxxx xxxxx xx. 6 xxxx. 2 a xxxxxxxx předložil xxxxx xxxx provedl xxxxxxxxxx xxxxx čl. 6 xxxx. 7; |
b) |
xxxxx xxxx xxxxxxxxxx Xxxxxx xxxxxx xxxxxxxxxxx orgánu xxxxx čl. 14 odst. 4 xxxxxxxx (XX) x. 1451/2007, xxx xxxxxxxxx zprávu xxxxx xxxxxxxxxxxx Xxxxx xxxxx pro xxxxxxxx xxxxxxxxx xxxxx xx. 15 xxxx. 4 xxxxxxxxx xxxxxxxx. |
2. Po xxxxxxx xxxxxx xxxxxxxx xxxxxxxxx a předloží Xxxxxx xxxxxxxxxx x xxxxxxxxx xxxxxxxxx xxxxx x xxxx přípravku xxxx jeho zařazení xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 přílohy X xxxxxxxx (XX) č. 528/2012, xxxxxxxx xxxxxx, s ohledem xx xxxxxx xxxxxxxxxxx xxxxxxxxxxx xxxxxx.
Xxxxxxxx xxxxxx přípravu xxxxxxxxxx x xxxxx x xxxxxx xxxx, xxxxx xxxx, xx xxxxxxx xxxxxxx:
x) |
xx xxx xxxxxx po xxxxxxx zprávy; |
b) |
xx lhůtě xxxxxxxxx x xxxxxxx III. |
Xxxxxxxx xxxxxxxx xxxxxxxxxx Xxxxxx xx 270 xxx xx xxxxxxxx xxxxxxxx.
Xxxxxx 8
Účinné xxxxx, xxxxx se xxxx xxxxxxxx
1. Xxx xxxxxxxx svého xxxxxxxxxx podle xx. 7 xxxx. 2 xxxxxxxx xxxxxxx, xxx xxxxxx xxxxx xxxxxxx xxxxxxx x xxxxxxxx xxxxxxxxx x xx. 10 xxxx. 1 xxxxxxxx (XX) č. 528/2012, x xxxx xxxxxx xxxxx xx xxxx xxxxxxxxxx.
2. Aniž xxxx xxxxxxx články 66 x 67 nařízení (EU) x. 528/2012, xxxxx xxx xxxxxxxx xxxxxxxx xxx xxxxxxxxxx Komisi, zveřejní xxxxxxxxx x xxxxxxx xxxxxxx, xxxxx xx xxxx xxxxxxxx, xxxxx xxxxxxxxx 60 xxx; x xxxx xxxx mohou xxxxxxxxxx xxxxx strany xxxxxxxxx příslušné xxxxxxxxx xxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxxx. Agentura obdržené xxxxxxxxx náležitě xxxxxxxx x závěrečné xxxx xxxxxxxx xxxxx xxxxxxxxxx.
3. Xxxxx xx xxxxxx xxxxx xxxxxxxxx x xxxxxxx xxxxx x xxxxxxxx xxxxxxxxxxx v čl. 10 xxxx. 1 xxxxxxxx (XX) x. 528/2012, xxxx xxx xxxxxxxx xx xxxxx, xxxxx xx má xxxxxxxx, x xxxxxxxx přijatém x xxxxxxx s čl. 89 xxxx. 1 xxxxxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxx.
Xxxxxx 9
Xxxxxxxxxx Xxxxxx
Xx xxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx xx. 7 xxxx. 2 Xxxxxx xxx xxxxxxxxxx xxxxxxxx xxxxxxxx xxxxx xxxxxxxxxx xxx xxxxxxx xxxxx xx. 89 odst. 1, xxxx xxxxxxxx xxxxx xx. 28 xxxx. 1 xxxxxxxx (XX) x. 528/2012.
XXXXXXXX 3
XXXXX XXXXX XXXXXXXX XXXXXXXX
Xxxxxx 10
Připojení xxxx xxxxxxxxx xxxxxxxxx xx xxxxxxxx xxxxxx
1.&xxxx;&xxxx;&xxxx;Xxxx xxxxxxxxx je možno xx vzájemné xxxxxx xxxx xxxxxxxxxx xxxxxxxxxx x xxxxxxxxxxxx xxxxxxxxxx xxxxxxx nebo xxxxxx xx xxxxxxxxxxx, xx xx xxxxxxxxxxx účastník xxxxx xxxxxxxxx se xx xxxxxxx údaje xxxxxxxxxx xxxx xxxxxxx xxxxxxxxxx xxxxxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxxx xxx xxxxx xxxxxx článku xxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxxxx účastník xxxxxxxxxxxxxxx xxxxxxxxx xxx xxxxxxxx xxxxxxxxx uvedeného x xxxxxx 71 xxxxxxxx (XX) x. 528/2012 (xxxx xxx „xxxxxxxx“) x&xxxx;xxxxxxxx musí xxxxxxxxx xxxxxxx příslušná xxxxxxxx x xxxxxxxx.
3.&xxxx;&xxxx;&xxxx;Xx xxxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx 2 xxxxxxxx xxxxxxxxxxx xxxxxxxxx v rejstříku xxxxxxxx xx totožnosti účastníka.
4. Osoba xxxxxxx na území Xxxx, xxxxx xxxxxxxx xxxx xxxxxxxxx xxxx xx xxxxxxxxx x účastníkovi xxxxx tohoto xxxxxx, xx xxx xxxxx xxxxxx 95 xxxxxxxx (XX) x.&xxxx;528/2012 považována xx xxxxx, která xxxxxxxxxx xxxxxxxxxxx xxxx xxxxxxxx k xxxxxxxx x xxxxxxxxxxx.
Xxxxxx 11
Odstoupení xxxxxxxxx
1. Xx xx xx to, xx účastník xxxxxxxxx x xxxxxx xx xxxxxxx xxxxxxxxx xxxxx x xxxx přípravku x xxxxxxxx xxxxxxxx, x xxxxxx xxxxxxxxx:
x) |
xxxxx xxxxxxxxxx agenturu xxxx xxxxxxxxx příslušný xxxxx prostřednictvím xxxxxxxxx x svém xxxxxx xxxxxxxxx; |
x) |
xxxxx nepředložil žádost xx xxxxx xxxxxxx x xx. 3 xxxx. 2; |
x) |
xxxxx xxxx xxxxxx xxxx xxxxxxxxx xxxxx xx. 4 odst. 1, xx. 4 xxxx. 4 xxxx xx. 5 xxxx. 4; |
x) |
xxxxx nepředložil xxxxxxxxxx xxxxxxxxx xx xxxxxxx uvedených x xx. 6 xxxx. 5; |
x) |
xxxxx xxxxx nezaplatil xxxxxxxx hodnotícímu xxxxxxxxxxx xxxxxx xxxx xxxxxxxx. |
2. Xxxxxxxxxx xx xxxxxxxx za xxxxxxxxx xxxx, xxxxx x němu xxxxxxx xx datu, kdy xxxxxxxxx příslušný xxxxx xxxxxxxxx žadateli zprávu xxxxxxxxxxx orgánu xxxxx xx. 6 odst. 4 xxxxxx xxxxxxxx.
Xxxxxx 12
Xxxxxxxx xxxxxxxx xxxxxxxxxx
1. Xxxxx je o xxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxx orgán, xxx xxxxxx agentura, xxxxxxxxx xx hodnotící xxxxxxxxx orgán xxx xxxxxxxxxx xxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxx xx x xxxxxxx xxxxxxxxxx informována xxxxxxxx, aktualizuje xxxxxxxxx x xxxxxxxxx týkající xx xxxxxxxxxx účastníka.
3. Pokud z xxxxxxxx přezkumu včas xxxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx x xxxxx xxxx role xxxxxxxxx xxx xxxxxxxx xxxxxxxxx xxxxx xxxxxxxx, xxxxxxxxx x xxx xxxxxxxx xxxxxxxxxxxxxxx rejstříku Xxxxxx.
Xxxxxx 13
Xxxx xxxxxxxx xxxxxxxxx látek
1. Xxxxx xxxxxxxxx xxxxxxxxx xxxxxx látky xxxxxxxx xxxxxxx xxxxxx xxxxxxxx se xxxxx, xxx xxxx xxxxxxx x xxxxxxx XX, xxxxxxxxx xxxxxxxxx xxxxx po konzultaci x xxxxxxxx xxxxxxxxxx xxxxxxx novou identitu xxxxx. Xxxxxxxxx příslušný xxxxx o tom informuje xxxxxxxx.
2. Xxxxxxxx x xxxxxxxxx aktualizuje xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxx.
Xxxxxx 14
Převzetí role xxxxxxxxx
1. Xxxxxxxx xxxxxxxx xxxxxxxxx xxxxx k převzetí xxxx účastníka xxx xxxxxxxxx látky x xxxx xxxxxxxxx, xxxxx xxxxxxx xxxxx x xxxxxx xxxxxxx:
a) |
xxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx xxxxx kombinaci látky x xxxx xxxxxxxxx xxxx xxxxxxxxxx xxxxx článku 11 x xxxxxx xxxx xxxxxxxxx xxx xxxxx xxxxxxxxx xxxxxx xxxxxxx xxxxxxxx; |
x) |
xx xxxxxxx xxxx xxxxxxxx xxxxx xxxxxx 13; x xxxxx xxxxxxx xx xxxxx xxxx xxxxx xx xxxxx, xx xxxxxx se vztahuje xxxxxxxxx xxxxxxxx x xxxxxxx XX, xxx nikoliv xxxx xxxxxxxx látky. |
2. Do dvanácti xxxxxx xxx xxx zveřejnění xxxxx xxxxxxxx 1 xxxx xxxxxxxxx osoba xxxxxxxxx xxxxxxxx xxx xxxxxxxxx xxxxx článku 17.
3. Xx xxxxxxxx xxxxxx od data xxxxxx tohoto xxxxxxxx x xxxxxxxx xxxx xxxxxxxxx xxxxx oznámit kombinaci xxxxx a typu xxxxxxxxx xxxxxxxxx xx části 2 přílohy II xxxxx xxxxxx 17.
Xxxxxx 15
Xxxxxxxxx látky x typu xxxxxxxxx xxxxxxxxx pro xxxxxxxx xx xxxxxxxx xxxxxxxx
Pokud xxxxxxxx přípravek, xxxxx xxxxx xx xxxxxxx xxxxxxxxxx xxxxxxxx (XX) x. 528/2012 x je xxxxxx xx xxx, xxxxxxx ze xxxxxxxxx xxxxxx xxxxx, xxx xxxx xxxxxxxxx ani xxxxxxxx xx xxxxxxxx xxxxxxxx xxx xxxxx xxx přípravku x xxxx xxxxxxxx xx xxxxxxx I xxxxxxxxx xxxxxxxx, xxxx látku xxxxxxxx xxxx xx x ní xxxxxx, xx xxxxxxx xxxxx xxxxxxxxx xxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxx xxxxxxxxx typ xxxxxxxxx xx xxxxxxx xxxxxxxxx z těchto xxxxxx:
x) |
xxxxx xxxxxxxxx výrobek xx xxx xx xxxxxxxxx xx xxxxxx xxxx xxxxxxx xxxxxxxxxx xxxxxx Xxxxxx xxxx xxxxxxxxxx xxxxxxx xxxxxxxxxx x xxxxxxx x xxxxxxx 26 směrnice 98/8/XX nebo xxxxxxx 81 xxxxxxxx (XX) x. 528/2012, xxxxx na xxxxxxx xxxxxxxxxx xxxxxxxxxxxxxx xxxxxx xxxxx xxxxxxx xxxxxx xx xxxxxxxxxx x xxxxxxxxxxx, xx xxxxxxx xxx xxxxx z působnosti směrnice 98/8/XX xxxx xxxxxxxx (XX) č. 528/2012, xxxx xx xxx xxxxxxxxx xxx přípravku xxxxxx x xxxxxxxxx, xxx xxxxx xxxx účinná xxxxx xxxxxxxx, a xxxxx xxxx uvedené xxxxxx či doporučení xxxxxxxx xxxxxxxxxxx v xxxxxxxxxx přijatém podle xx. 3 xxxx. 3 xxxxxxxx (XX) x. 528/2012 xxxx v nových, xxxxxxxxx xxxxxxxx xxxxxxxxxxxx Xxxxxx; |
b) |
xxxxx xxxxxxxxx xxxxxxxx pro xxxxxxxxx x xxxxxx stanovené x xxxxxx 6 xxxxxxxx (XX) x. 1451/2007; |
c) |
biocidní přípravek xxxxx xxxxx xxxxxxxx (XX) x. 528/2012 x xxxxxxxxx xxxx xxxxxxxxx, xxx xxxx xxxx xxxxx xxxxxxxx 98/8/XX, x xxxxxxxx xxxxx xxxxxxxxxx xxxxxx xxxx xxxxxxxxx x xxxxxxxx xxxxx xxxxxxxxx xx xxxxxxxx xxxxxxxx xxx xxxxxxx xxx přípravku, xxx xxxxxx xxx xxxx. |
Xxxxxx 16
Xxxxxxxxxx x xxxxx xx oznámení
1. Prohlášení x xxxxx oznámit xxxxx, xxxxx xx způsobilá xxx xxxxxxxx do programu xxxxxxxx xxxxx xxxxxx 15, předkládá prostřednictvím xxxxxxxxx xxxxxxxxx xxxxx, xxx má xxxxx xxxxxxx kombinaci xxxxx x xxxx xxxxxxxxx, jednomu x xxxxxxxxxxxxx příjemců:
a) |
Komisi xxxxxxxxxx xxxxxxx xxxxxx xx xxxxxxxxxx rozhodnutí xxxx xxxxxx xxxxxxxxx x xx. 15 xxxx. x); |
x) |
xxxxxxxx xxxxxxxxxx 30. října 2015 x xxxxxxxxx xxxxxxxxx x čl. 15 xxxx. x); |
c) |
Komisi xxxxxxxxxx 30. xxxxx 2015 v případech xxxxxxxxx v čl. 15 xxxx. x). |
2. Xxxxxxxxxx xxxx obsahovat xxxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx. X xxxxxxxxx xxxxxxxxx v čl. 15 xxxx. x) musí prohlášení xxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx, x xxxx vyplývá, xx xxxx xxxxxxx xxxxxxx podmínky x xxx xxxxxxx.
3. Pokud xxxx xxxxxxxxxx učiněno x xxxxxxx xxxxxxxx x xx. 15 xxxx. x) xxxx x) x Xxxxxx xxxxxxx xx xxxxxxxxxx x xxxxxxxxx xxxxx x xxxxxx, že xxxxxxxx 6 xxxx xxxxxxxxxx, x xxxxxxxx, xx xxxx splněny xxxxxxxx xxx xxxxxxxx xxxxxxx x xx. 15 písm. x), xxxxxxx x tom xxxxxxxx.
4. Xxxxx xxxx xxxxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 xxxx. x) xxxx pokud Xxxxxx xxxxxxxxxxx xxxxxxxx podle xxxxxxxx 3, zveřejní agentura xxxx informaci xxxxxxxxxxxxxx xxxxxxxxxx s uvedením xxxxxxxxx xxxxxxxxx látky x xxxx xxxxxxxxx. Pro xxxxx xxxxxx nařízení xx xxxxxxxxxx xxxxx čl. 3a xxxx. 3 xxxxxxx xxxxxxxxxxx xxxxxxxx (ES) č. 1451/2007 xxxxxxxx za xxxxxxxxxx xxxxx xxxxxx xxxxxxxx.
5. Kterákoli xxxxx, která xx xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx, tak xxxx xxxxxx podle xxxxxx 17 xx xxxxx xxxxxx xxx dne xxxxxxxxxx xxxxx xxxxxxxx 4.
6. X xxxxxxxxx xxxxxxxxx x čl. 15 písm. x) x x) xx xxxxxxxxx látky x xxxx xxxxxxxxx xxxxxxxx xx xxxxxxxxx účastníkem x xxxx xxxxxxxxx x xxxxxxx xxxxxxxx, xxxxx xxxx xxxxxxx xxxx xxxxxxxx:
a) |
příslušná xxxxxx xxxxx xx xxx xxxxxxxx xx xxxxxxxx xxxxxxxx; |
x) |
xxxxxxxxxxx xxxxxxxxxx hodnotícímu xxxxxxxxx xxxxx pro xxxxxxxxxx xxxxxxx xxxxx xxx obsahuje xxxxxxx xxxxx, xxxxx xxxx xxxxxxxx xxx xxxxxxxxx xxxx xxxxxxxxx; |
x) |
xxxxxxxx, xxxxx xxxxxxxxx xxxxxxxx dokumentaci, xxxxx, xx má xxxxx x xxxxxxx xxxx kombinace xxxxx x xxxx xxxxxxxxx. |
Xxxxxx 17
Xxxxxx xxxxxxxx
1. Xxxxxxxx xxxxx xx. 14 xxxx. 2 x 3 xxxx xx. 16 xxxx. 5 xx xxxxxxxxxxx agentuře xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxxxxx musí xxx xxxxxxxxxx ve formátu XXXXXX. Musí xxxxxxxxx xxxxx uvedené x xxxxxxx X.
3. Pokud není x xxxxxxx XX pro xxxxxxxx xxxxxxx xxxxx xxxxxx xxxxxxxxx xxxxxxxxx xxxxx, xxxxxxxxx xxxxxxxxxxx xxxxxxxx x xxxxx xxx xxxxxxxxx xxxxxxxxxxx orgánu, který xx jmenován v souladu x xxxxxxx 81 xxxxxxxx (EU) x. 528/2012, x xxxxxxxx xxxxxxx xxxxxxxxx dokládající, že příslušný xxxxx souhlasí s xxx, xx xxxxxxxxxxx xxxxxxx.
4. Xx obdržení oznámení x xxx xxxxxxx xxxxxxxx Xxxxxx a xxxxxxxxxxxx xxxxxxxxx o poplatcích xxxxxxxxx xxxxx xxxxxxxx (XX) č. 564/2013. Xxxxxxxx xxxxxxxxxxx xxxxxxxx xxxxxxxx xx 30 dnů xx xxxxxxx xxxxxxx xxxxxxxxx, agentura xxxxxxxx xxxxxxx a xxxxxxx x xxx oznamovatele x Xxxxxx.
5. Po xxxxxxxx xxxxxxxx xxxxxxxx do 30 dnů ověří, xxx xxxxxxxx vyhovuje xxxxxxxxxx xxxxxxxx v xxxxxxxx 2. Xxxxx xxxxxxxx těmto požadavkům xxxxxxxxxx, xxxxxxxx agentura xxxxxxxxxxxx xxxxx x xxxxx 30 xxx, xxx xxx xxxxxxxx xxxxxxx xxxx xxxxxxx. Xx xxxxxxxx xxxx 30xxxxx xxxxx xxxxxxxx xx 30 dnů xxx xxxxxxxx, xx xxxxxxxx vyhovuje xxxxxxxxxx xxxxxxxx 2, xxxx xxxxxxxx zamítne, x xxx xxxxxxxxxx xxxxx xxxxxxxxxxxx x Xxxxxx.
6. X xxxxxxx x xxxxxxx 77 xxxxxxxx (XX) x. 528/2012 xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 4 xxxx 5 podat xxxxxxx xxxxxxxxxx.
7. Xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxx odstavce 5:
a) |
v xxxxxxx, že bylo xxxxxxxx předloženo xxxxx xx. 14 odst. 2 xxxx 3, xxxxxxxx neprodleně xxxxxxxxxxx xxxxxxxxx x xxxxxxxxx týkající se xxxxxxxxxx účastníka x xxxxxxxx xxxxxxxx xxxxx; |
b) |
x xxxxxxx, že oznámení xxxx xxxxxxxxxx xxxxx xx. 16 xxxx. 5, xxxxxxxx xxxxxxxxxx xxxxxxxxx Xxxxxx, xx xxxxxxxxxx xxxx xxxxxxxx. |
Xxxxxx 18
Zařazení do xxxxxxxx přezkumu
Xxxxx xx xxxxxxxxx látky a typu xxxxxxxxx považována xx xxxxxxxxx x xxxxxxx x xx. 16 xxxx. 6 nebo xxxxx xxxxxxxx xxxxxxxxx Komisi x dodržení xxxxxxxxx x xxxxxxx s čl. 17 xxxx. 7 xxxx. x), zařadí Xxxxxx xxxxxxxxx xxxxx x xxxx přípravku do xxxxxxxx xxxxxxxx.
Xxxxxx 19
Xxxxxxxxx x xxxxxxx, xxxxx xxxxxx xxxxxx xxxxxxxxxxx x xxxxx programu xxxxxxxx
Xxxxx xxxxxx xx xxxxx stanovené x xx. 16 xxxx. 5 xxxxxxxx xxxxx oznámení nebo xxxxx xxxx xxxxxxxx xxxxxxx ve xxxxxxxx xxxxxx xxxxxxx x xxxxxxxx xxxxxxxxx xxxxxxxxx podle xx. 17 odst. 4 xxxx 5, xxxxxxxx x xxx xxxxxxxxx xxxxxxx xxxxx xxxxxxxxxxxxxxx rejstříku x xxxxxxxx xxxx xxxxxxxxx elektronickou xxxxxx.
Xxxxxx 20
Rozhodnutí Komise x xxxxxxx, xxxxx xxxxxx xxxxxx xxxxxxxxxxx x xxxxx xxxxxxxx xxxxxxxx
Xxxxxx připraví xxxxx xxxxxxxxxx x xxxxxxxxxxx xxxxx čl. 89 odst. 1 xxxxxxx pododstavce xxxxxxxx (XX) č. 528/2012 x xxxxxx xxxxxxxxx:
x) |
xxxxx xxxxxxxx xxxxxxxxx Xxxxxx o včasném xxxxxxxxxx xxxxxxxxx xxxxx xx. 12 xxxx. 3 xxxxxx xxxxxxxx; |
x) |
xxxxx xxxxx xxxxx xxxxxxxx xxxxxxxx xx xxxxxxx stanovených x xx. 14 xxxx. 2 nebo 3 tohoto xxxxxxxx xxxx pokud bylo xxxxxxxx předloženo x xxxxxxxxx xxxxx xx. 17 xxxx. 4 xxxx 5; |
c) |
xxxxx xxxx xxxxxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx x xx. 14 xxxx. 2 xxxx 3 xxxxxx xxxxxxxx x xxxx xxxxxxxx xxxxxxxxx xxxxx xx. 17 xxxx. 5 tohoto xxxxxxxx, xxx xxxxxxxx látky x xxxxxxxx xxxxxxxx xxxxx xxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX xxxxxx nařízení. |
X xxxxxxx xxxxxxxx x xxxxxx pododstavci xxxx. x) xx xxxxx rozhodnutí x xxxxxxxxxxx xxxxxxxx xx xxxxxx xxxxx, na kterou xx xxxxxxxx stávající xxxxxxxx x xxxxxxx XX xxxxxx xxxxxxxx, avšak xxxxxx xxxxxxxx xxxx jakékoli xxxxxxxxxx x schválení.
KAPITOLA 4
XXXXXXXXX XXXXXXXX
Xxxxxx 21
Xxxxxxxxx xxxxxxxx pro xxxxx uvedené x&xxxx;xxxxxx&xxxx;15
1.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx může pokračovat x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx xxxx xxxxx xxxxxxxx xx&xxxx;xxx a používání xxxxxxxxxx xxxxxxxxx, xxxxx xxxxxxx xx xxxxxxxxx xxxxxx látky xxxxxxx x čl. 15 xxxx. x) x x), xxxx xxxxx xxxxxxxx nebo z xx vzniká. X xxxxxx xxxxxxxxx:
x) |
xxxxx xxx xxxxxxxx xxxxxxxxx nadále xxxxxxx na trh x&xxxx;xxxxxxx xx&xxxx;24 xxxxxx po xxxx xxxxxx tohoto xxxxxxxx v platnost; |
b) |
stávající xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxx dále využívány xx&xxxx;30 xxxxxx xx xxx vstupu xxxxxx xxxxxxxx x&xxxx;xxxxxxxx. |
2.&xxxx;&xxxx;&xxxx;Xxxxxxx stát xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx systému xxxx xxxxx xxxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxxxx biocidního xxxxxxxxx, který sestává xx xxxxxxxxx xxxxxx xxxxx xxxxxxx x xx. 15 xxxx. x), tuto xxxxx xxxxxxxx xxxx z xx xxxxxx. V xxxxxx xxxxxxxxx:
x) |
xxxxx xxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;24 xxxxxx xx xx z dále xxxxxxxxx xxxxxxxx, xxxxx xxxxxxx xxxxxxx:
|
x) |
xxxxxxxxx xxxxxx biocidního přípravku xxxxx xxx dále xxxxxxxxx xx&xxxx;30 xxxxxx xx xx z xxxx uvedených xxxxxxxx, xxxxx xxxxxxx xxxxxxx:
|
3.&xxxx;&xxxx;&xxxx;Xxxxxxx stát xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx nebo xxxxx xxxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxxxx xxxxxxxxxx xxxxxxxxx, xxxxx sestává xx xxxxxxxxx xxxxxx xxxxx xxxxxxxxxx xxxxxxxxx xxxxx xx. 16 xxxx. 4 xxx xxxxxxxxx xxx xxxxxxx, xxxx xxxxx obsahuje xxxx x xx xxxxxx. X těchto případech:
a) |
nesmí xxx xxxxxxxx xxxxxxxxx xxxxxx dodáván na trh x&xxxx;xxxxxxx xx&xxxx;xxxxxxxx měsíců xx datu, xxx xxxxxxxx provedla xxxxxxxxxxxx xxxxxxxxxx xxxxx článku 19 a |
b) |
stávající xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxx xxxx xxxxxxxxx xx&xxxx;xxxxxxxx xxxxxx xx xxxx xxxxxxxxx xxxxxxxxxx. |
Xxxxxx 22
Xxxxxxxx xxxxxxx
1. Aniž xx xxxxxx xx. 55 xxxx. 1 nařízení (XX) x. 528/2012, xx xxxxxxxx měsíců xx xxxx rozhodnutí x xxxxxxxxxxx xxxxxxxxx xxxxxx xxxxx, xxxxx členský xxxx xxxxxxxx xxxx xxxxxxxxx xxxxxxx xxxxx xx xxxxxxxxx x xxxxxx xxxxxxxxx x xx. 5 xxxx. 2 xxxxxx pododstavci xxxx. b) nebo x) xxxxxxxx (XX) x. 528/2012, xxxxx xxxxxxx xxxx xxxx předložit Xxxxxx xxxxxxxxxxx xxxxxx x xxxxxxxx od čl. 89 odst. 2 xxxxxxx xxxxxxxxxxx uvedeného xxxxxxxx.
2. Xxxxxxxx členský xxxx xxxxxxxx odůvodněnou xxxxxx xxxxxxxx prostřednictvím xxxxxxxxx. Xxxxx xxxxxx xxxxxxxx xxxxxxx xxxxxxxxx, žádající xxxxxxx xxxx xxxx xxxxxxx xxxxxxxxx xxxxxxxxx xxxxx.
3. Xxxxxxxx xxxxxxxx xxxxxx xxxx případně xxxxxxxxxx xxxxx elektronickými prostředky. Xxxxxxx xxxxx xxxx xxxx xxxxx xxxxx xxxxx xxxxxxxxxx xx xxxxx 60 dnů xx xxxxxxxxxx.
4. Xx xxxxxxx xxxxxxxxxx xxxxxxxxxx může Xxxxxx xxxxxxx xxxxxxxx xx xx. 89 xxxx. 2 xxxxxxx pododstavce xxxxxxxx (XX) č. 528/2012, xxxxx umožní xxxxxx xxxxxxxx přípravky, xxx xxxxxxxxx x této xxxxx, xxxxxxxx xx xxxx x ní xxxxxxxx, xx xxx xxxxxxxxxx xxxxxxxxx xxxxx x xxxxxxxx je x xxxxx xxxxxxxx státu x xxxxxxx x xxxxxxxxxxxxxx xxxxxxxx xxxxxxxx x x xxxxxxxx xxxxxxxx xxxxxxxx 5 x xxxxxxxxx dalších xxxxxxxx xxxxxxxxx Xxxxxx.
5. Členský xxxx, xxxxx je xxxxxxxx odchylka:
a) |
zajistí, xx xxxxx xxxxxxxxx xxxx xxxxxxx xx xxxxxx xxxxxxx x xxxxxxx xxxx, xxx xxxx xxxxxx xxxxxxxx xxxxxxxx 1; |
x) |
xxxxxx xxxxxx opatření xx xxxxxxxx xxxxx, xxx xxxxxxxx minimalizaci expozice xxxxxxx, xxxxxx nebo xxxxxxxxx xxxxxxxxx; |
c) |
xxxxxxx, xxx xx xxxxxxx xxxxxxxxxxxx xxxxxx nebo aby xxxx včas xxxx xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxx x xxxxxxxxx xxxxxx xxxxx x xxxxxxx xxxxxxx 7 nařízení (XX) č. 528/2012. |
XXXXXXXX 5
XXXXXXXXX USTANOVENÍ
Článek 23
Xxxxxxx
Xxxxxxx xx xxxxxxxx (XX) č. 1451/2007.
Odkazy xx xxxxxxx nařízení xx xxxxxxxx xx xxxxxx na xxxx xxxxxxxx.
Xxxxxx 24
Xxxxx v xxxxxxxx
Xxxx xxxxxxxx xxxxxxxx x xxxxxxxx dvacátým xxxx po xxxxxxxxx x Xxxxxxx xxxxxxxx Xxxxxxxx unie.
Xxxx xxxxxxxx xx xxxxxxx x xxxxx xxxxxxx x přímo xxxxxxxxxx xx všech xxxxxxxxx xxxxxxx.
X Xxxxxxx xxx 4. srpna 2014.
Xx Komisi
xxxxxxxx
Xxxx Xxxxxx XXXXXXX
(1)&xxxx;&xxxx;Xx. xxxx. X 167, 27.6.2012, x. 1.
(2)&xxxx;&xxxx;Xxxxxxxx Xxxxxx (XX) x. 1451/2007 ze xxx 4. prosince 2007 x xxxxx xxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxx x xx. 16 xxxx. 2 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx 98/8/XX x xxxxxxx xxxxxxxxxx xxxxxxxxx na xxx (Úř. věst. X 325, 11.12.2007, x. 3).
(3) Směrnice Xxxxxxxxxx xxxxxxxxxx x Rady 98/8/ES xx xxx 16. xxxxx 1998 o xxxxxxx xxxxxxxxxx xxxxxxxxx xx trh (Úř. xxxx. X 123, 24.4.1998, x. 1).
(4) Rozsudek Soudního dvora (xxxxxxx xxxxxx) xx xxx 1. xxxxxx 2012 (xxxxxx o xxxxxxxxxx x xxxxxxxxx xxxxxx: Xxxxxxxxxxx Xxxxxxx – Xxxxxxx) – Xöxx GmbH xxxxx Xxxxx XxxX (uvádění xxxxxxxxxx xxxxxxxxx na xxx – směrnice 98/8/XX – xx. 2 xxxx. 1 xxxx. x) – xxxxx „xxxxxxxx přípravky“ – xxxxxxxxx, xxxxx xxxxxxxxx vločkování xxxxxxxxxx xxxxxxxxx, xxxx xx xxxx, xxxxxxxx xxxx xxxxxxxxxxx), X-420/10.
(5)&xxxx;&xxxx;Xxxxxxxxx nařízení Komise (XX) x.&xxxx;88/2014 xx xxx 31.&xxxx;xxxxx 2014, xxxxxx xx xxxxxxx xxxxxx xxx xxxxx xxxxxxx X&xxxx;xxxxxxxx Evropského xxxxxxxxxx a Rady (XX) x.&xxxx;528/2012 x&xxxx;xxxxxxxx xxxxxxxxxx xxxxxxxxx na xxx x&xxxx;xxxxxx xxxxxxxxx (Úř. xxxx. X 32, 1.2.2014, s. 3).
(6)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 1272/2008 xx xxx 16. prosince 2008 x xxxxxxxxxxx, xxxxxxxxxx a xxxxxx xxxxx x směsí, x změně x xxxxxxx směrnic 67/548/XXX x 1999/45/XX x x xxxxx xxxxxxxx (XX) x. 1907/2006 (Xx. xxxx. X&xxxx;353, 31.12.2008, s. 1).
(7)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Komise (XX) č. 564/2013 xx xxx 18.&xxxx;xxxxxx 2013 x&xxxx;xxxxxxxxxx x&xxxx;xxxxxxxx xxxxxxxxx Xxxxxxxx agentuře xxx xxxxxxxx látky xxxxx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (EU) x.&xxxx;528/2012 x&xxxx;xxxxxxxx xxxxxxxxxx xxxxxxxxx xx trh x&xxxx;xxxxxx xxxxxxxxx (Úř. věst. L 167, 19.6.2013, s. 17).
(8)&xxxx;&xxxx;Xxxxxxxx Evropského xxxxxxxxxx x Rady (XX) x. 1907/2006 xx xxx 18. xxxxxxxx 2006 x xxxxxxxxxx, xxxxxxxxx, xxxxxxxxxx x xxxxxxxxx xxxxxxxxxx xxxxx, x xxxxxxx Xxxxxxxx xxxxxxxx xxx xxxxxxxx xxxxx, x změně xxxxxxxx 1999/45/XX a x xxxxxxx xxxxxxxx Xxxx (EHS) x.&xxxx;793/93, xxxxxxxx Xxxxxx (XX) x. 1488/94, xxxxxxxx Xxxx 76/769/EHS x xxxxxxx Xxxxxx 91/155/XXX, 93/67/XXX, 93/105/XX x 2000/21/XX (Úř. věst. X 396, 30.12.2006, x. 1).
XXXXXXX I
Xxxxxxxxx xxxxxxxxxx xxx oznámení podle xxxxxx 17
Xxxxxxxx xxxxx xxxxxx 17 obsahuje xxxx xxxxxxxxx:
1) |
xxxxx, xx xxxxx xx xxxxxxxxx xxxxxxx xxxxxx xx xxxxxx xx. 3 xxxx. 1 písm. d) xxxxxxxx (XX) x. 528/2012; |
2) |
xxxxx o xxxx/xxxxxx xxxxxxxxx, xx xxxxx/x xx oznámení xxxxxxxx; |
3) |
xxxxxxxxx o všech xxxxxxxx, xxxxx byly zadány xxx xxxxx xxxxxxx x xxxxxxxxx xx zařazení xx xxxxxxx I nařízení (XX) x. 528/2012, xxxxx x xxxxxxxxx xxxxx jejich xxxxxxxxx; |
4) |
xxxxxxxxx xxxxxxx v xxxxxxxx
|
5) |
pokud xxxx xxxx xxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 písm. x), xxxxx, xx xxxxx xxxx xx xxxx xxxx xxxxxx xxxxx biocidního xxxxxxxxx xxxxxxxxxxx xx xxxxxxxxxxx typu xxxxxxxxx x xxx oznámení xxxx xxxxxxxxxx xxxxxxxxxx xxxx xxxxxx xxxxxxxxx xx xxxxxxxx písmenu. |
XXXXXXX II
KOMBINACE XXXXX X XXXX XXXXXXXXX XXXXXXXX XX XXXXXXXX XXXXXXXX XXX 4. XXXXX 2014
XXXX 1
Xxxxxxxxx xxxxxx látky x xxxx xxxxxxxxx xxxxxxxxxxx xx xxx 4. xxxxx 2014, x xxxxxxxx xxxxxxxxxx jiných nanomateriálů xxx těch, xxxxx xxxx výslovně uvedeny x xxxxxxxxx 1017 a 1019.
Xxxxx xxxxxxx |
Xxxxx látky |
Členský xxxx xxxxxxxxx |
Xxxxx XX |
Číslo CAS |
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18 |
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21 |
22 |
1 |
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XX |
200-001-8 |
50-00-0 |
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6 |
5-{[2-(2-butoxyethoxy)ethoxy]methyl}-6- xxxxxx-1,3-xxxxxxxxxxx (xxxxxxxxxxxxxxxx/XXX) |
XX |
200-076-7 |
51-03-6 |
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9 |
xxxxxxxx |
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200-143-0 |
52-51-7 |
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29 |
xxxxxxxxxxx |
XX |
200-431-6 |
59-50-7 |
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36 |
xxxxxxx |
XX |
200-578-6 |
64-17-5 |
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37 |
xxxxxxxx xxxxxxxx |
XX |
200-579-1 |
64-18-6 |
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x |
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x |
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x |
x |
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40 |
xxxxxx-2-xx |
XX |
200-661-7 |
67-63-0 |
x |
x |
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x |
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43 |
kyselina xxxxxxxxxx |
NL |
200-712-3 |
69-72-7 |
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x |
x |
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45 |
propan-1-ol |
XX |
200-746-9 |
71-23-8 |
x |
x |
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52 |
xxxxxxxxxxx |
X |
200-849-9 |
75-21-8 |
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60 |
xxxxxxxx xxxxxxxxx |
XX |
201-069-1 |
77-92-9 |
x |
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69 |
xxxxxxxxx xxxxxxxx/2-xxxxxxxxxxxxxxx xxxxxxxx |
LT |
201-180-5 |
79-14-1 |
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x |
x |
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70 |
kyselina xxxxxxxxxxxx |
XX |
201-186-8 |
79-21-0 |
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71 |
X-(+)-xxxxxx xxxxxxxx |
XX |
201-196-2 |
79-33-4 |
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79 |
2-xxxxxxxxxxx-8,9-xxxxxxxxx-1,2,6,6x,12,12x-xxxxxxxxxxxxxxxxx[3,4-x]xxxx[2,3-x]xxxxxxx-6-xx (xxxxxxx) |
UK |
201-501-9 |
83-79-4 |
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85 |
xxxxxxxxx |
XX |
201-782-8 |
87-90-1 |
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92 |
xxxxxxx-2-xx |
ES |
201-993-5 |
90-43-7 |
x |
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113 |
xxxxxxxxxxxxx/3-xxxxxxxxx-2-xxxx (xxxxxxxxxxxxx) |
XX |
203-213-9 |
104-55-2 |
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117 |
xxxxxxxx |
XX |
203-377-1 |
106-24-1 |
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122 |
xxxxxxx |
XX |
203-474-9 |
107-22-2 |
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133 |
xxxx-2,4-xxxxxxx kyselina (xxxxxxxx xxxxxxx) |
XX |
203-768-7 |
110-44-1 |
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136 |
xxxxxxxx (xxxxxxxxxxxxx) |
XX |
203-856-5 |
111-30-8 |
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154 |
xxxxxxxxx |
N |
204-385-8 |
120-32-1 |
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171 |
2-xxxxxxxxxxx-1-xx |
XX |
204-589-7 |
122-99-6 |
x |
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172 |
cetylpyridinium-chlorid/1-hexadecylpyridin-1-ium-chlorid |
UK |
204-593-9 |
123-03-5 |
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179 |
oxid xxxxxxxx |
XX |
204-696-9 |
124-38-9 |
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x |
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180 |
(xxxxxxx-xxxxxxxxx) – natrium-dimethylarsinát |
PT |
204-708-2 |
124-65-2 |
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x |
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185 |
xxxxxxxxxxxxxx, sodná xxx (sodná sůl xxxxxxxxxxxxxxx – xxxxxxxxx X) – (X-xxxxx-4-xxxxxxxxxxxx-1-xxxxxxxxxx |
XX |
204-854-7 |
127-65-1 |
|
x |
x |
x |
x |
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187 |
kalium-dimethyldithiokarbamát |
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 |
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 (thiabendazol) |
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 |
xxxxxxxxxxxxx |
DE |
206-992-3 |
420-04-2 |
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x |
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x |
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253 |
xxxxxxxxxx-3,5-xxxxxxxx-1,3,5-xxxxxxxxxx-2-xxxxx (xxxxxxx) |
XX |
208-576-7 |
533-74-4 |
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x |
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x |
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279 |
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) |
XX |
214-118-7 |
1085-98-9 |
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x |
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x |
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289 |
thiokyanatan xxxxx |
XX |
214-183-1 |
1111-67-7 |
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x |
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292 |
[(1,3-xxxxx-1,3,4,5,6,7-xxxxxxxxx-2X-xxxxxxxx-2-xx)xxxxxx]-xxxxx-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxx-xxxxxxxxxxxx) |
XX |
214-619-0 |
1166-46-7 |
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x |
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958 |
xxxxxxxx vápenatý/hydratované xxxxx/xxxxxx xxxxx |
XX |
215-137-3 |
1305-62-0 |
|
x |
x |
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959 |
xxxx xxxxxxxx/xxxxx/xxxxxx vápno/nehašené xxxxx |
XX |
215-138-9 |
1305-78-8 |
|
x |
x |
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306 |
xxxx xxxxx |
XX |
215-270-7 |
1317-39-1 |
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x |
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315 |
xxxxx-2-xx-xxxxxxx |
XX |
215-661-2 |
1338-23-4 |
x |
x |
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321 |
xxxxxxxxxxx |
UK |
217-129-5 |
1746-81-2 |
|
x |
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330 |
X-(3-xxxxxxxxxxx)-X-xxxxxxxxxxxxx-1,3-xxxxxx (xxxxxx) |
XX |
219-145-8 |
2372-82-9 |
|
x |
x |
x |
|
x |
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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) |
ES |
220-120-9 |
2634-33-5 |
|
x |
|
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x |
|
|
x |
|
x |
x |
x |
|
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|
341 |
2-methyltetrahydroisothiazol-3(2H)-on (XXX) |
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 (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 (xxxxxxx 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 (xxxxxxxxx xxxxx) |
SE |
223-296-5 |
3811-73-2 |
|
x |
x |
|
|
x |
x |
|
x |
x |
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x |
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368 |
1-(3-xxxxxxxxxx)-3,5,7-xxxxxx-1-xxxxxxxxxxxxxxx-xxxxxxx (XXXX) |
XX |
223-805-0 |
4080-31-3 |
|
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x |
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x |
x |
|
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377 |
1,3,5-xxxx(2-xxxxxxxxxxxx)xxxxxxxxx-1,3,5-xxxxxxx (XXX) |
XX |
225-208-0 |
4719-04-4 |
|
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x |
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x |
x |
x |
|
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|
382 |
1,3,4,6-xxxxxxxx(xxxxxxxxxxxxx)xxxxxxxxxxxxxxxx[4,5-x]xxxxxxxx-2,5-xxxx (XXXX) |
XX |
226-408-0 |
5395-50-6 |
|
x |
|
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|
x |
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x |
x |
x |
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387 |
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 |
stříbro |
SE |
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 |
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 sodný |
XX |
231-668-3 |
7681-52-9 |
x |
x |
x |
x |
x |
|
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x |
x |
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434 |
xxxxxxxxxxxx |
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) |
XX |
231-810-4 |
7747-35-5 |
|
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x |
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x |
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450 |
xxxxxxxx xxxxxxxx |
XX |
231-853-9 |
7761-88-8 |
x |
|
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453 |
peroxodisíran xxxxx |
XX |
231-892-1 |
7775-27-1 |
|
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x |
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|
455 |
xxxxxxxx xxxxxxxx |
XX |
231-908-7 |
7778-54-3 |
|
x |
x |
x |
x |
|
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x |
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457 |
xxxxx |
XX |
231-959-5 |
7782-50-5 |
|
x |
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x |
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x |
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|
458 |
xxxxx xxxxxx |
UK |
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 |
oxid xxxxxxxxxx |
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 |
|
|
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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 |
ES |
237-030-0 |
13590-97-1 |
|
|
|
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|
x |
|
|
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|
x |
|
|
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|
526 |
xxxxxx-xxxxxxx-2-xxxx |
XX |
237-243-9 |
13707-65-8 |
|
|
|
|
|
x |
|
|
x |
x |
|
|
x |
|
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|
529 |
xxxxxxxxxxxxxxx |
XX |
237-601-4 |
13863-41-7 |
|
|
|
|
|
|
|
|
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|
x |
|
|
|
|
|
|
|
531 |
(benzyloxy)methanol |
XX |
238-588-8 |
14548-60-8 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
534 |
xxx(1-xxxxxxxxxxxxxx-2(1X)-xxxxxxxx-X,X)xxxxxxx xxxxxxx (xxxxxxxxx xxxx) |
XX |
238-984-0 |
14915-37-8 |
|
|
|
|
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|
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|
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|
x |
|
541 |
xxxxxxx-4-xxxxx-3-xxxxxxxxxxxxx |
XX |
239-825-8 |
15733-22-9 |
x |
x |
x |
|
|
x |
|
|
x |
|
|
|
x |
|
|
|
|
|
550 |
5,5′-xxx(4-xxxxxxxxxx)-1,1′-(xxxxx-1,6-xxxx)xxx(xxxxxxxx)-xxx(x-xxxxxxxx) (XXXX) |
PT |
242-354-0 |
18472-51-0 |
x |
x |
x |
|
|
|
|
|
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|
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|
|
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|
|
554 |
4-[(dijodmethyl)sulfonyl]-1-methylbenzen |
UK |
243-468-3 |
20018-09-1 |
|
|
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|
|
559 |
[(xxxxxxxxxxxx-2-xx)xxxxxxxx]xxxxxx-xxxxxxxxxx (XXXXX) |
X |
244-445-0 |
21564-17-0 |
|
|
|
|
|
|
|
|
x |
|
|
x |
|
|
|
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|
562 |
[2-xxxxxx-4-xxx-3-(xxxx-2-xx-1-xx)xxxxxxxxx-2-xx-1-xx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (prallethrin) |
XX |
245-387-9 |
23031-36-9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
563 |
xxxxxx-(X,X)-xxxx-2,4-xxxxxxx (xxxxxx xxxxxxxx) |
XX |
246-376-1 |
24634-61-5 |
|
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
|
566 |
α, α′,α′′-xxxxxxxxxxxxxxxxxx-1,3,5-xxxxxxx-1,3,5-xxxxxxxxxx (HPT) |
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 |
ES |
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 |
XX |
251-835-4 |
34123-59-6 |
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
|
|
|
|
597 |
1-[2-(xxxxxxxx)-2-(2,4-xxxxxxxxxxxx)xxxxx]xxxxxxxx (xxxxxxxx) |
XX |
252-615-0 |
35554-44-0 |
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 (DBDCB) |
CZ |
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 xxxxxxxxxxx xxxxx |
XX |
254-454-1 |
39445-23-3 |
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 (xxxx) (xxxxxxxxxx) |
UK |
255-953-7 |
42822-86-6 |
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x |
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614 |
(RS)-α-kyano-3-fenoxybenzyl-(1RS)-cis,trans-3-(2,2-dichlorvinyl)-2,2-dimethylcyklopropanekarboxylát (xxxxxxxxxxxx) |
XX |
257-842-9 |
52315-07-8 |
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x |
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615 |
3-xxxxxxxxxxxx(1XX,3XX;1XX,3XX)-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (xxxxxxxxxx) |
IE |
258-067-9 |
52645-53-1 |
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x |
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x |
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618 |
[1-ethynyl-2-methylpent-2-en-1-yl]-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyklopropan-1-karboxylát (empenthrin) |
XX |
259-154-4 |
54406-48-3 |
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x |
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619 |
3-xxxxxxx-2-xx-1-xx-X-xxxxxxxxxxxxx (XXXX) |
XX |
259-627-5 |
55406-53-6 |
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x |
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x |
x |
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x |
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620 |
xxxxxxxx(xxxxxxxxxxxxx)xxxxxxxxx-xxxxxx (2:1) (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 (propikonazol) |
XX |
262-104-4 |
60207-90-1 |
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x |
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635 |
xxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxx xxxxx (XXXXX/XXXX) |
XX |
263-038-9 |
61789-18-2 |
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x |
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648 |
4,5-xxxxxxx-2-xxxxxxxxxxxxxxx-3(2X)-xx (4,5-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) |
XX |
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 (cyromazin) |
EL |
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 |
alkyl(C12-18)dimethylbenzylammoniumchlorid (XXXXX (X12-18)) |
XX |
269-919-4 |
68391-01-5 |
x |
x |
x |
x |
|
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x |
x |
x |
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x |
671 |
alkyl(C12-16)dimethylbenzylammoniumchlorid (XXXXX/XXX (X12-X16)) |
XX |
270-325-2 |
68424-85-1 |
x |
x |
x |
x |
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x |
x |
x |
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x |
673 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxxx (DDAC) (X8-10) |
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) |
XX |
273-545-7 |
68989-01-5 |
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x |
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x |
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691 |
xxxxxxx-X-(xxxxxxxxxxxxx)xxxxxxxx |
XX |
274-357-8 |
70161-44-3 |
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x |
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|
692 |
alkyl(C10-C16)dimethylaminoxidy |
PT |
274-687-2 |
70592-80-2 |
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x |
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693 |
bis(peroxosíran)-bis(síran) xxxxxxxxxxxxx |
XX |
274-778-7 |
70693-62-8 |
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x |
x |
x |
x |
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701 |
xxxxxxxxx-xxxxxxxxxxxxxxxx hexahydrát (XXXX) |
PL |
279-013-0 |
84665-66-7 |
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x |
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1015 |
xxxxxxx, Xxxxxxxxxxx xxxxxx, xxxxxxx |
XX |
283-644-7 |
84696-25-3 |
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x |
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724 |
xxxxx(X12-X14)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXX (C12-C14)) |
XX |
287-089-1 |
85409-22-9 |
x |
x |
x |
x |
|
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x |
x |
x |
|
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x |
725 |
alkyl(C12-C14)ethylbenzylammoniumchlorid (ADEBAC (X12-X14)) |
XX |
287-090-7 |
85409-23-0 |
x |
x |
x |
x |
|
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x |
x |
x |
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x |
731 |
xxxxxxxxx stračkolistá, Xxxxxxxxxxxxx xxxxxxxxxxxxxxxx, xxxxxxx |
XX |
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 |
reakční produkty xxxxxxxxx kyseliny x X-xxxxx(X12-X14)xxxxxx-1,2-xxxxxxx (glukoprotamin) |
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 (XXXX) |
CZ |
420-590-7 |
4299-07-4 |
|
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x |
x |
|
x |
x |
|
|
x |
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792 |
komplex xxxxxxxxxxxxxxxxxxx (XXXX) |
XX |
420-970-2 |
92047-76-2 |
x |
x |
|
x |
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811 |
xxxxxxxxxxxxxxxxxxx xxxxxxxx-xxxxx-xxxxxxxxxxx |
XX |
422-570-3 |
265647-11-8 |
x |
x |
|
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-((Z)-3-chlorallyl)-3,5,7-triaza-1-azoniaadamantanchlorid (xxx-XXXX) |
XX |
426-020-3 |
51229-78-8 |
|
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x |
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x |
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800 |
{[2,5-xxxxx-3-(xxxx-2-xx-1-xx)xxxxxxxxxxxx-1-xx]xxxxxx}-2,2-xxxxxxxx-3- (2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx- 1-xxxxxxxxxx (xxxx stereoisomerů) (xxxxxxxxxxx) |
UK |
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) |
XX |
433-460-1 |
210880-92-5 |
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x |
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952 |
Bacillus xxxxxxxxxx 2362, xxxx XXXX-1743 |
XX |
xxxxxxxxxxxxxxx |
143447-72-7 |
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x |
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955 |
Xxxxxxxx xxxxxxxxxxxxx xxxxx. xxxxxxxxxxx, xxxx XX3X |
XX |
xxxxxxxxxxxxxxx |
není 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-xxxxx-2-xxxxxxxxxxxxxxxx-3(2X)-xx (Xxxxxx 247-500-7) a 2-methylisothiazol-3(2H)-on (Xxxxxx 220-239-6), směs (3:1) (směs XXXX/XXX) |
XX |
xxxx |
55965-84-9 |
|
x |
|
x |
|
x |
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x |
x |
x |
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939 |
xxxxxxx xxxxx (vyráběný reakcí xxxxxxxx xxxxxxx a xxxxxxxxx sodného in xxxx) |
XX |
xxxx |
xxxx relevantní |
|
x |
x |
x |
x |
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813 |
xxxxxxxxxxxxxx xxxxxxxx |
FR |
není xxxxxxxxxx |
33734-57-5 |
|
x |
x |
x |
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1014 |
xxxxxxxx zeolit |
XX |
xxxx relevantní |
xxxx xxxxxxxxxx |
|
x |
|
x |
x |
|
x |
|
x |
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849 |
3-xxxxxxxxxxxx-(1X,3XX)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxxxxxx) |
IE |
není relevantní |
188023-86-1 |
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x |
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|
931 |
xxxxxxxxxxxxxxxxxxxxxxx, X-X12-14(xx xxxxx číslem), xxxxxxxx xxxxxx x xxxxxxxxxxxx xxxxxxxxx (Ampholyt 20) |
XX |
xxxx xxxxxxxxxx |
139734-65-9 |
|
x |
x |
x |
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|
152 |
produkty xxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-xxxxx-5-xxxxxxxxxxxxxxxx x xxxxxx x chlorem (XXXXX) |
XX |
xxxx x xxxxxxxxx |
xxxx x xxxxxxxxx |
|
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x |
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459 |
xxxxxxx xxxx xxxxx xxxxxxxxxxxx x xxxxxxxx stříbrného |
SE |
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 |
není k dispozici |
|
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x |
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810 |
xxxxxxxxxxxxxx xxxx x xxxxxxx 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 |
SE |
xxxx x xxxxxxxxx |
130328-19-7 |
|
x |
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x |
x |
|
x |
|
x |
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1017 |
xxxxxxx xxxxxxxxxxx xx xxxxx xxxxxxxxxx (xxxx xxxxxxxxxxxx xx xxxxx xxxxxxxxxx xxxxxxxx x xxxxxxxxxx částicemi xx xxxxxxxxxx) |
XX |
xxxx k dispozici |
není x xxxxxxxxx |
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x |
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1019 |
xxxx křemičitý (xxxx xxxxxxxxxxxx xxxxxxx xxxxxxxx x xxxxxxxxxx) |
XX |
xxxx k dispozici |
68909-20-6 |
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x |
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831 |
xxxxxxxxx |
FR |
přípravek xx xxxxxxx xxxxxxx |
61790-53-2 |
|
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x |
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854 |
(XX)-3-xxxx-2-xxxxx-4-xxxxxxxxxxxx-2-xxxx-(1X,3X;1X,3X)-2,2-xxxxxxx-3-(2-xxxxxxxxx-1-xxxx)-xxxxxxxxxxxxxxxxxxxxx (směs 4 xxxxxxx 1X xxxxx, 1X: 1R xxxxx, 1X: 1R xxx, 1X: 1X xxx, 1S 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 (směs 2 xxxxxxxxxxxxx) (xxxxxxxxxx) |
XX |
xxxxxxxxx na xxxxxxx rostlin |
260359-57-7 |
|
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x |
|
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|
848 |
N-[(6-chlor-3-pyridyl)methyl]-N′-kyan-N-methylethanimidamid (xxxxxxxxxxx) |
BE |
xxxxxxxxx xx xxxxxxx rostlin |
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 ochranu 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 |
xxxxxxxxx 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 |
|
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859 |
xxxxxxx X-xxxxxxxxxxxxxxxxx(XXXXXX 204-697-4) x (xxxxxxxxxxx)xxxxxxxx (XXXXXX 203-439-8)/xxxxxxxxx xxxxxxxxx chlorid xxxxxx (XX Xxxxxxx) |
XX |
xxxxxxx |
25988-97-0 |
|
x |
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|
x |
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863 |
xxxx(xxxxxxxx-1,5-xxxxxxxxx-1,6-xxxx) (PHMB) |
FR |
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 |
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) |
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) |
EL |
xxxxxxx |
214710-34-6 |
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x |
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ČÁST 2
Xxxxxxxxx účinné xxxxx x xxxx xxxxxxxxx xxxxxxxxxxxxx xx xxx 4. xxxxx 2014
Tato xxxx xxxx xxxxxxx xxxxxxxx
— |
xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxx x xxxxxxx xxxx, xxxxxx xxxxxxxxxx xxxxxxxxx, |
— |
xxxxxxxx xxxxxxxxx xxxxx kombinací xxxxx a typu xxxxxxxxx xxxxxxxxx v tabulce v části 1, xxxxx xxxx, xxxxx xxxx xxxxxxx v tabulce, x |
— |
xxxxxxxx nanoformy xxxxx xxxxxxxxx xxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxxxx xx 4. srpna 2014, x xxxxxxxx xxxx, xxxxx xxxx xxxxxxxx xxxxxxxxx. |
Xxxxxxxxx xxxxx x xxxx xxxxxxxxx x xxxxxxxxxxxxx xxxxxxxx xx xxxx části xxxxx xxxxxxxxx xxxxxxxxxx x xxxxxxxxxxx podle xxxxxx 20, jestliže xxxxx xxxxx nepodá xxxxxxxx xx xxxxxxxx xxxxxx xx xxxxxx tohoto xxxxxxxx v platnost xxxxx xx. 14 xxxx. 3 nebo xxxxx xx xxxxxx xxxxxxxx xxxxxxxxx podle xx. 17 odst. 4 nebo 5.
Xxxxx položky |
Xxxxx xxxxx |
Xxxxxxx xxxx zpravodaj |
Číslo XX |
Xxxxx 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 xxxxxxxxxx xxxxx položky 152) |
XX |
204-258-7 |
118-52-5 |
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x |
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166 |
xxxxxx(xxxxxxxxx)xxxxxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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204-526-3 |
122-18-9 |
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167 |
benzyl(dimethyl)oktadecylamonium-chlorid (xxx xxxxxxx 948) |
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204-527-9 |
122-19-0 |
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213 |
xxxxxx(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxxx (xxx položka 948) |
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205-351-5 |
139-07-1 |
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214 |
xxxxxx(xxxxxxxx)xxxxxxxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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205-352-0 |
139-08-2 |
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227 |
2-(xxxxxxx-4-xx)xxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
205-725-8 |
148-79-8 |
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x |
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331 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxx (xxx xxxxxxx 949) |
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219-234-1 |
2390-68-3 |
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384 |
xxxxxxxx(xxxxxxx)xxxxxxx-xxxxxxx (viz 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 |
XX |
231-545-4 |
7631-86-9 |
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x |
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449 |
síran 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 (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 (permethrin) |
XX |
258-067-9 |
52645-53-1 |
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x |
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637 |
alkyl(benzyl)dimethylamonium-chloridy (xxxxx odvozen xx xxxxxxxx kyselin xxxxxxxxxx xxxxx) (xxx xxxxxxx 948) |
|
263-080-8 |
61789-71-7 |
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638 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (alkyl odvozen xx mastných xxxxxxx xxxxxxxxxx oleje) (xxx xxxxxxx 949) |
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263-087-6 |
61789-77-3 |
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639 |
dialkyl(dimethyl)amonium-chloridy (xxxxx xxxxxxx od hydrogenovaných xxxxxxxx xxxxxxx xxxx) (xxx položka 949) |
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263-090-2 |
61789-80-8 |
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647 |
xxxxx(X8-X18)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxx položka 948) |
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264-151-6 |
63449-41-2 |
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668 |
xxxxxxx(X6-X12)xxxxxxxxxxxxxxx-xxxxxxxx (xxx xxxxxxx 949) |
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269-925-7 |
68391-06-0 |
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670 |
alkyl(C8-C16)benzyl(dimethyl)amonium-chloridy (xxx xxxxxxx 948) |
|
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 |
alkyl(C10-C16)dimethylaminoxidy |
PT |
274-687-2 |
70592-80-2 |
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x |
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697 |
dialkyl(C8-C18)dimetylamonium-chloridy (xxx xxxxxxx 949) |
|
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 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) |
|
293-522-5 |
91080-29-4 |
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1020 |
1,3-xxxxxxx-5-xxxxx-5-xxxxxxxxxxxxxxxxxx-2,4-xxxx (nově xxxxxxxxxx xxxxx xxxxxxx 777) |
XX |
401-570-7 |
89415-87-2 |
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x |
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778 |
1-(4-xxxxxxxxxx)-4,4-xxxxxxxx-3-[(1X-1,2,4-xxxxxxx-1-xx)xxxxxx]xxxxxx-3-xx (xxxxxxxxxxx) |
XX |
403-640-2 |
107534-96-3 |
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x |
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805 |
xxxxxxx xxxxxxx xxxxxxxx-xxxxxxx, xxxxxxxx-xxxxxxxxx x dimethyl-sukcinátu x xxxxxxxxx xxxxxx (xxxxxxxx) |
XX |
432-790-1 |
xxxx xxxxxxxxxx |
|
x |
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923 |
alkyl(benzyl)dimethylamonium-chlorid/benzalkonium-chlorid (xxx xxxxxxx 948) |
|
směs |
8001-54-5 |
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949 |
(dialkyl)dimethylamonium-chloridy, -xxxxxxx xxxx -methyl-sulfáty) (xxxxxx (X6-X18) nasycené a xxxxxxxxxx, xxxxxxxx xx xxxxxxxx xxxxxxx xxxx, xxxxxxxxxx xxxxx x xxxxxxxx xxxxx) (DDAC) |
XX |
směs xxxxx xxxxxxxxx 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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950 |
alkyltrimethylamonium-chloridy, -xxxxxxx xxxx -xxxxxx-xxxxxxx) (xxxxxx (X8-X18) nasycené x xxxxxxxxxx, odvozené xx xxxxxxxx kyselin xxxx, xxxxxxxxxx xxxxx x xxxxxxxx xxxxx) (XXXX) |
XX |
xxxx látek uvedených x seznamu EINECS |
xxxx xxxxxxxxxx |
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x |
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948 |
xxxxxx(xxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx xxxx -xxxxxxxxx) (alkyly (C8-C22) xxxxxxxx x xxxxxxxxxx, xxxxxxxx od xxxxxxxx xxxxxxx loje, xxxxxxxxxx xxxxx x xxxxxxxx xxxxx) (XXX) |
XX |
xxxx xxxxx xxxxxxxxx x seznamu 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 (d-fenothrin) |
IE |
xxxx xxxxxxxxxx |
188023-86-1 |
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x |
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|
1001 |
alkyl(C12-C16)benzyl(dimethyl)amonium-chloridy (xxxx xxx xxxxx xxxxxxxxx pod xxxxxxx 671) |
XX |
xxxx relevantní |
xxxx 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 spadající xxx xxxxxxx 667) |
IT |
xxxx xxxxxxxxxx |
xxxx relevantní |
x |
x |
x |
x |
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x |
x |
x |
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x |
1003 |
xxxxx(X12-X18)(xxxxxxxxxxx)xxxxxxxxxxxxxxx- chloridy (xxxx xxx látka xxxxxxxxx xxx xxxxxxx 725) |
XX |
xxxx relevantní |
xxxx relevantní |
x |
x |
x |
x |
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x |
x |
x |
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x |
1005 |
xxxxx(X12-X14)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxx xxx xxxxx xxxxxxxxx xxx xxxxxxx 724) |
XX |
xxxx xxxxxxxxxx |
xxxx relevantní |
x |
x |
x |
x |
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x |
x |
x |
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x |
1006 |
xxxxxxxxxxxxxx xxxx xxxxxxxxxx xxxxxxx, xxxxx, xxxxxx 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) |
IT |
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 (xxxxx xxxxxxx xx mastných xxxxxxx kokosového oleje) (xxxx xxx xxxxx xxxxxxxxx pod xxxxxxx 635) |
XX |
xxxx xxxxxxxxxx |
xxxx relevantní |
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x |
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1012 |
xxxxxxxxxxxxxxxxx xxxxx, xxxxxxxx x xxxxxxxxx komplex/stříbrno-zinečnatý xxxxxx |
SE |
není xxxxxxxxxx |
130328-20-0 |
|
x |
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x |
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x |
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598 |
(±)-1-(β-xxxxxxxx-2,4-xxxxxxxxxxxxxxxxx)xxxxxxxx (xxxxxxxx technický) |
XX |
přípravek xx xxxxxxx rostlin |
73790-28-0 |
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x |
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XXXXXXX XXX
Xxxxx
Xxxx xxxxxxxxx |
Xxxxx xxx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx xx. 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 a 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 x 22 |
31.12.2022 |
31.9.2023 |