XXXXXXXX XXXXXX X XXXXXXXXX XXXXXXXXX (XX) x. 1062/2014
xx xxx 4. xxxxx 2014,
týkající se xxxxxxxxxx programu xxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx látek obsažených x xxxxxxxxxx xxxxxxxxxxx, xxxxx xxxx xxxxxxx v xxxxxxxx Xxxxxxxxxx parlamentu x Xxxx (XX) x. 528/2012
(Xxxx x významem pro XXX)
XXXXXXXX KOMISE,
x xxxxxxx xx Xxxxxxx o fungování Xxxxxxxx xxxx,
x ohledem xx xxxxxxxx Xxxxxxxxxx parlamentu x Xxxx (XX) x. 528/2012 xx xxx 22. xxxxxx 2012 x xxxxxxxx xxxxxxxxxx přípravků xx xxx x xxxxxx xxxxxxxxx (1), x xxxxxxx xx xx. 89 xxxx. 1 xxxxx xxxxxxxxxxx uvedeného xxxxxxxx,
xxxxxxxx x těmto důvodům:
(1) |
Nařízení Xxxxxx (XX) x. 1451/2007 (2) xxxxxxx prováděcí xxxxxxxx xxx program xxxxxxxx xxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx (xxxx xxx „xxxxxxx xxxxxxxx“), xxxxx xxx xxxxxxx x xxxxxxx x xx. 16 xxxx. 2 směrnice Xxxxxxxxxx parlamentu x Xxxx 98/8/XX (3). Xxxxxxx tato xxxxxxxx xxxx zrušena x xxxxxxxxx xxxxxxxxx (EU) x. 528/2012, měla by xxx prováděcí xxxxxxxx xxx pokračování programu xxxxxxxx přizpůsobena xxxxxxxxxxx xxxxxxxxx xxxxxxxx. |
(2) |
Je xxxxxxxx xxxxx xxxxxxxxx účinné xxxxx x typu xxxxxxxxx, xxxxx xxxxx xxx xxxxxxxx na trh x xxxxxxxxx podle xxxxxxxxxxx xxxxxxxxxx xxxxxx 89 xxxxxxxx (XX) x. 528/2012 x xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx. Xxxx xx xxxx xxx x x xxxxxxx xxxxxxxxx účinné látky x xxxx xxxxxxxxx, xxxxx jsou xxxxxxxxx x xxxxxxxx přezkumu. |
(3) |
Xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx xxx potraviny x xxxxxx xxxxx xxxxxx 6 xxxxxxxx (XX) x. 1451/2007, xxx nevztahuje xx xx xxx výjimka xxx xxxxxxxxx a krmiva xxxxxxx v čl. 2 xxxx. 5 xxxx. x) xxxxxxxx (XX) x. 528/2012, xxxx by xxx účinné xxxxx, xxxxx obsahuje, hodnoceny x xxxxxxxx xxxxxxxx xxx xxxxxxxxx xxx xxxxxxxxx. X xxxxxxxx vnitrostátních předpisů xx mělo xxx xxxxxx xxxxxxxx na trh x xxxxxxxxx umožněno až xx xxxxxxxx xxxxxxxxx xxxxxxxxx. Xxxxxx předchozího xxxxxxxxxx xx xxx xxxxxxx, xxxxx xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxx. Xxxxx xx mělo xxxxxx x xxxxxxxxx, xxx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx x nové xxxxxxxx xxxx přípravků x xxxxxxxx (XX) x. 528/2012 xxxxxx xxxxxxxx xxxxxxx xx xxxxxxxx 98/8/ES nebo xx xxxxx odůvodněno xxxxxxxxxxx Komise přijatým x xxxxxxx s čl. 3 xxxx. 3 xxxxxxxx (XX) x. 528/2012, xxxxxxxxxxx (například rozhodnutím xx xxxx C-420/10 (4)) xxxx xxxxxxxxx xxxxxx Xxxxxx či příslušných xxxxxx xxxxxxxxx xxxxx, xxxxx se následně xxxxxxx. |
(4) |
Xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxx xxxxx, xxxxx xxx není xxxxxxxx xx xxxxxxxx xxxxxxxx, x této xxxxx xxxxxxx xxxx xx z ní xxxxxx, xxxxx xxxxxxxx xx xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxx x xxxxxxxx xxxxx nezbytné, xxxx xx xxx v tomto xxxxxxxx xxxxx xxxxxxx x xxxxxxxx xx xxx xxxxxxxx xx xxxx xxxxxxxxxxxx, za určitých xxxxxxxx x xx xxxxxxxx xxxx. |
(5) |
X xxxxx xxxxxxxxxxx x xxxxxxxxxxxx by xxx xxx postup hodnocení xxxxxxxx xxxxx v programu xxxxxxxx ve xxxxx xxxxxxxxxx xxxxxxx xxxxxxx x xxxxxxxx xxxxxxxxxx xxx xxxxxxx předložené xxxxx xxxxxx 7 xxxxxxxx (XX) x. 528/2012 xxxx xxxxx prováděcího xxxxxxxx Xxxxxx (EU) x. 88/2014 (5). |
(6) |
Pro xxxxx, které xxxxxxx xxxxxxxx xxxxxxxxx xxxx xxxxxxxx pro xxxxxxx, xx xxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxxxxx a označení xxxxx xxxxx xx. 37 xxxx. 1 xxxxxxxx Xxxxxxxxxx parlamentu x Xxxx (XX) x. 1272/2008 (6), xxxxx jde x xxxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxx, x xxxxxxx xx xxxx xxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx týkající xx jiných nebo xxxxx xxxxxxxxxxx xxxxxxxxxx. Xxxxxxxxx příslušný orgán xx xxx také xxxxxxxxxxx xxxxxxxx x xxxxxxx xxxxx, xxxxx xx xxxxxxxxx kritéria xxx xxxxx xxxxxxxxxxxx, xxxxxxxxxxxxxxx xx xxxxxxx, xxxx xxxxx, xxxxx by xxxxx být považovány xx xxxxx x xxxxxxxxxxx xxxxxxxxxxxxxx narušení xxxxxxxxxx xxxxxxxx. |
(7) |
Xxx xxxx xxxxxxxxx, xx xxxxxxx xxxxxxxx xxxx dokončen xx xxxxxxxx xxxx xxxxxxxxx x xx. 89 xxxx. 1 xxxxxxxx (XX) x. 528/2012, xxxx xx xx xxxxxxxxx xxxxxx xx xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx, x nichž xxxx příslušné xxxxx xxxxxxxxxx xx xxxxxxx stanovených x xxxxxxxx (XX) č. 1451/2007 xxxx x xxxxx xxxxxxxx. Xxxxx toho xx xx xxxx stanovit xxxxxx xxxxx xxx xxxxxxxxx hodnocení, xxxxxxx xx xx xxxx xxxx x úvahu xxxxxxx, xx žádosti xx mohly xxx xxxxxxxxx méně xxx xxx xxxx xxxxxxxxx xxxxxx xxxx. |
(8) |
Ohledně xxxxxxxx xx xxxxxxx X xxxxxxxxx 7 nařízení (XX) č. 528/2012 xxxxx xxxxxx xxxxxxxxx xxxxx xxxxxxxxx na xxxxx. Xx xxxxx xxxxxx x xxxx xxxx xxxxxx žádosti x xxxxxxxx xx xxxxxxx přílohy xx xxxxxxxxx 1, 2, 3, 4, 5 nebo 6. |
(9) |
Xxx xxxxxx xx xx. 90 xxxx. 2 xxxxxxxx (XX) x. 528/2012 xxxxxxx z článku 91 xxxxxxxxx xxxxxxxx, že xxxxxxxx xxxxxxx v článku 10 xxxxxxxxx xxxxxxxx xx xxxx xxx relevantní xxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx ve všech xxxxxxxxx. Je xxxxx xxxxxx xxxxx látky xxxxxxxxx tato kritéria xx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx. |
(10) |
Xxxxxxxxxxx účastník xxxxxxxx xxxxxxxx by měl xxx xxxxxxx xx xx xxxxxxxx xxxxxx xxxxxxxx ke xxxxxxxxxxx xxxxxxxxxxx xxxx jej xxxxxxxx xx xxxxxxxxxxx, xx kvůli xxxx xxxxxxx xx xxxxxxxx xxxxxxxxx x xxxxxx xxxxxxxxx xxxxxxxx k xxxxxx, xxxxxxx jinak by xxxxxxxxxxx xxxxxxxx musel xxxxxxxxx xxxxx xxxxx. |
(11) |
Xxxxxxx xx xxxxx v programu xxxxxxxx xxxxxxxxxx, mělo xx být xxxxxxxxxx xxxxxxxx xx xx xxxxxxxxx. Xxxxx k xxxx xxxxx, měli xx xxx xxxxxxxxxxx xxxxxxxxx xxxxxxx převzít xxxxxxx, nebylo-li xxxx xxxxxxxx xxxxxxx xxx xxxxxx, xxxxx xxx xxxxxxx ke zpoždění xxxxxxxx xxxxxxxx, x xxxxxxxx-xx xxxxxxxx již xxxxxxxx na svém xxxxxxxxxx. |
(12) |
Xxxxx xx xxx xxxxxxxxx účinné látky xxxxx, xx xxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxxxxx neodpovídá identitě xxxxxxxx xxxxxxxxx xxxxx, x x hodnocení nelze xxxxxxx xxxxxx xxxxxxx xxxxxxxx xxxxxxxxx zařazené xxxxx, mělo by xxx možné xxxx xxxxx x xxxxxxx xxxxxxxxx xxxxx xxxxxxxxx a povolit xxxxx osobám, xxx xxxxxxxx podporu této xxxxxxxxx xxxxxxxx xxxxx. |
(13) |
Xxxxxxx xxxxx xxxxxxxx do xxxxxxxx xxxxxxxx xxxxxx x xxxx xxxxxxx xxxxxx xxxxxxxx xxxxxxxxxxx xxxxxx účastníkem. Xxxxx xx xxxx xxxxxxxx xxxxxxxxxxxxx, ačkoli podle xx. 4 odst. 4 xxxxxxxx (XX) x. 528/2012 xxxx xxxxxxxxx xxxxx schválit, xxxxx xxx není xxxxxxxx xxxxxxxxx. X xxxxxxxxx xxxxx a xxxxxxxxxxxxx xx xxxx xxx xxxxx xxxxxxx xxxxxxx účast, xxxxxxx xxxxx xx xxxx xxxxx x xxxxxxxxxxxxx xxxxxx xxx x programu xxxxxxxx xxxxxxxxx. |
(14) |
Xxx xxxx xxxxxxxxx, xx xxxxx xxxxx nezůstane x xxxxxxxx xxxxxxxxxxx xxx xx xxx xxxxxx xxxxxxxx, xxxx xx xxxxxxxx xxxx xxxxxxxxxxx, xxxx xx xxxxxxxx xxxxx, xxxxx xxxxx xxxxxx xxxxxxxxx, v xxxxxxxx nebo xxxx xxxxxxxx xxxxxxxx oznamování xxxxxxxxxx údajů o xx, |
XXXXXXX XXXX XXXXXXXX:
XXXXXXXX 1
PŘEDMĚT A XXXXXXXX
Xxxxxx 1
Předmět
Toto nařízení xxxxxxx xxxxxxxx pro xxxxxxxxx pracovního xxxxxxxx xxxxxxxxxxxxxx přezkumu xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx x&xxxx;xxxxxx&xxxx;89 xxxxxxxx (XX) č. 528/2012.
Xxxxxx 2
Definice
Xxx xxxxx xxxxxx xxxxxxxx se xxxxxxx xxxx xxxxxxxx:
a) |
„xxxxxxxxxxx x xxxxxxxxxxx“ se xxxxxx xxxxxxxxxx neschválit xxxxxxxxx xxxxx x xxxx xxxxxxxxx podle xx. 9 xxxx. 1 xxxx. x) xxxxxxxx (XX) x. 528/2012 xxxx xx. 89 xxxx. 1 třetího xxxxxxxxxxx uvedeného xxxxxxxx, xxxx xxxxxxxxx xxxxxxxxx xx xxxxxxx X xxxx XX xxxxxxxx 98/8/XX; |
b) |
„xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx xx xxxxxxxx přezkumu“ xx xxxxxx xxxxxxxxx xxxxx x xxxx přípravku uvedená x xxxxxxx XX, která xxxxxxx tyto xxxxxxxx:
|
x) |
„účastníkem“ xx xxxxxx xxxxx, xxxxx xxxxxxxxxx xxxxxx x xxxxxxxxx xxxxx a typu xxxxxxxxx zařazené do programu xxxxxxxx xxxx xxxxxxxxxx xxxxxxxx, xxxxx xxxxxxxx xxxxxxxxxx xxxxx xx. 17 xxxx. 5 tohoto xxxxxxxx, xxxx xxxxxx jménem xxxx xxxx xxxxxx xxxx xxxxxxxx předloženo; |
d) |
„xxxxxxxxxx xxxxxxxxxx orgánem“ xx xxxxxx xxxxxxxxx orgán xxxxxxxxx státu xxxxxxxxx x xxxxxxx XX xxxxxx xxxxxxxx, xxxxxx x xxxxxxx s článkem 81 xxxxxxxx (XX) č. 528/2012. |
XXXXXXXX 2
XXXXXX XXXXXXXXX XXXXXXXXXXX
Xxxxxx 3
Xxxxxx x xxxxxxxxx xxxx xxxxxxxx xx xxxxxxx X xxxxxxxx (XX) x. 528/2012
1.&xxxx;&xxxx;&xxxx;Xxxxxx o schválení či xxxxxxxx xx&xxxx;xxxxxxx I nařízení (XX) x.&xxxx;528/2012 může xxxxx xxxxx xxxxxxxx, x jehož oznámení xxxxx xxxxxxxx x xxxxxx, xx xxxxxxxx xxxxxxxxxx xxxxx xx.&xxxx;17 xxxx.&xxxx;5 xxxxxx nařízení.
Pokud xx žádost xxxx xxxxxxxx xx&xxxx;xxxxxxx I nařízení (XX) č. 528/2012, xxxx xx týkat xxxxx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx xxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxx uvedené x&xxxx;xxxxxxxx 1 se podávají xxxxxxxx xx&xxxx;xxxx xxx xx xxxxxxxxxx x&xxxx;xxxxxxx x požadavky xxxxx xx.&xxxx;17 xxxx.&xxxx;5.
Xxxxxx 4
Xxxxxxx žádostí
1. Xxxxxxxx xxxxxxxxx xxxxxxxxx o xxxxxxxx xxxxxxxx podle xxxxxxxxxxx xxxxxxxx Xxxxxx (XX) č. 564/2013 (7) x xxxxxxx xxxxxx, xxxxx xxxxxxxx nezaplatí xxxxxxxx ve xxxxx 30 xxx. X xxxx skutečnosti xxxxxxxxx xxxxxxxxx x xxxxxxxxx xxxxxxxxx xxxxx.
2. Xx xxxxxxxx xxxxxxxx splatných xxxxx xxxxxxxxxxx nařízení (XX) x. 564/2013 xxxxxx xxxxxxxx žádost x xxxxxxxxx x xxx xxxxxxxxx x xxxxxxxxx příslušný xxxxx, xxxxxxx xxxxx xxxxx xxxxxxx žádosti a její xxxxxxxxx xxxxxxxxxxxxx xxx.
3. Xxxxx xxxxxxxxxxx agentury xxxxx xxxxxxxx 1 xxxxxx xxxxxx xxx podat xxxxxxx xxxxxxxxxx v xxxxxxx s článkem 77 xxxxxxxx (EU) x. 528/2012.
4. Xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxx xxxxxxxx xxxxx xx. 80 xxxx. 2 xxxxxxxx (XX) x. 528/2012 xx 30 xxx xxxx, co agentura xxxxxxx xxxxxx, x xxxxxxx xxxxxx, pokud xxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxx 30 xxx. X xxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxx.
Xxxxxx 5
Xxxxxxxxx žádostí x xxxxxxxxx xxxx xxxxxxxx do kategorie 6 xxxxxxx I xxxxxxxx (EU) x. 528/2012
1. Xxxxx xxxxxxxx xxxxxx xxxxx čl. 4 xxxx. 2 žádost x xxxxxxxxx nebo xxxxxxxx xx xxxxxxxxx 6 přílohy X xxxxxxxx (XX) x. 528/2012, xxxxx xxxxxxxx údaje xxxxxxxxxx x xxxxxxx x xx. 6 xxxx. 1 x 2 xxxxxxxxx xxxxxxxx, a byl xxxxxxxx xxxxxxxx xxxxx xx. 4 xxxx. 4, xxxxxxxxx xxxxxxxxx xxxxx xxxxxx xxxxxxx do 30 xxx xx xxxxxxxxx xxxxxxxx.
2. Xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxx od účastníka xxxxxxxxxxx xxxxx nařízení (XX) x. 1451/2007, avšak xx xxxxx xxxxxx xxxxxx xxxx xxxxx podle xxxxxx 13 xxxxxxxxx xxxxxxxx, xxxxxxx hodnotící xxxxxxxxx xxxxx žádost xxxxxxxxxx do 3. xxxxx 2015.
3. X případech xxxxxxxxx x odstavcích 1 x 2 xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx xxxxxxx ani xxxxxxxxxxxx předložených xxxxx xxxx xxxxxxxxxx.
4. Xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxx, xx xxxxxx xx xxxxxxx, xxxxx xxxxxxxxxxx, xxxx xxxxxxxxxx xxxxxxxxx xxxx x xxxxxxxxx xxxxxxx nutné, x x xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx přiměřenou xxxxx. Tato xxxxx xxxxx xxxxxxxxxx 90 xxx.
Xxxxxxxx-xx xxxxxxxxx xxxxxxxxx xxxxx, xx xxxxxxxxxx doplňující xxxxxxxxx xxxxxxxxx xx xxxxxxx xxxxxxxxx uvedených x odstavci 2, xxxxxxx žádost do 30 xxx xx xxxxxxxx xxxxxxxxxxxx xxxxxxxxx.
Xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxxxxxxxx lhůtě xxxxxxxxxx, xxxxxxxxx příslušný xxxxx xxxxxx xxxxxxx x xxxxxxxxx x xxxx xxxxxxxxxxx xxxxxxxxx x xxxxxxxx. X xxxxxx případech xx xxxxx xxxxxxxx zaplacené x xxxxxxx x xx. 80 odst. 1 x 2 nařízení (EU) x. 528/2012.
Xxx potvrzení xxxxxxx xxxxxxxxx příslušný xxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxx, xxxxxxxx x xxxxx xxxxxxxxx xxxxxx x xxxxx xxxxx xxxxxx xxxxxxxxx.
Xxxxxx 6
Xxxxxxxxx žádostí
1. Xxxxx xxxxxx xx xxxxxxx, xxxxx xxxxx xxxxxxx x xxxxxx xxxxxxxx:
x) |
xx-xx xxxxxx xxxxxxxxx xxxxx xxxxxx 5; |
x) |
xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxxxx xxxx úplnou xxxxx xxxxxx 13 xxxxxxxx (XX) x. 1451/2007, xxx dosud xxxxxxxxxxx Xxxxxx xxxxxx xxxxxxxxxxx orgánu podle xx. 14 odst. 4 xxxxxxxxx xxxxxxxx; |
x) |
xxxxx agentura xxxxxxx xxxxxx o zařazení xx xxxxxxxxx 1, 2, 3, 4 xxxx 5 xxxxxxx X xxxxxxxx (XX) x. 528/2012 xxxxx xx. 4 xxxx. 2 a xxx xxxxxxxx xxxxxxxx xxxxx čl. 4 odst. 4. |
2. Xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx xxxxxx xxxxx článků 4 a 5 xxxxxxxx (EU) x. 528/2012 a xxxxxxxx xxx xxxxxxx xxxxxx xx xxxxxx xxxxxxxxx xx údaje xxxxxxxxxx x souladu x xx. 6 odst. 3 uvedeného xxxxxxxx x xxxxx xxxxxxxxx xxxxxx x xxxxxx xxxxx hodnocení agentuře.
3. Pokud xxxxxxx kombinaci látky x xxxx xxxxxxxxx xxxxxxxxx xxxxxxx účastníků, xxxxxxxxx hodnotící xxxxxxxxx xxxxx xxxxx jednu xxxxxxxxx zprávu. Hodnotící xxxxxx x xxxxxx xxxxx x xxxxx z těchto xxxx, podle xxxx, xx nastane xxxxxxx:
x) |
365 xxx xx xxxxxxxxx xxxxxxxxx uvedeném x xxxx. 1 xxxx. x), xxxxxx xxxxxxxx xxxxxxxx x xxxx. 1 písm. b) xxxx xxxxxxxxx xxxxxxxx xxxxxxxxx v odst. 1 xxxx. x) x xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx; |
x) |
xx xxxxx xxxxxxxxx v příloze XXX. |
4. Xxxx xxx, než xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx xxx xxxxxx xxxxxxxx, umožní xxxxxxxxxxx xxxxx xx 30 xxx k xxxxxxxxx xxxxxx x x xxxxxxx hodnocení xxxxxxx xxxxxxxxxx. Hodnotící xxxxxxxxx xxxxx tyto připomínky xxxxxxxxxxxxx xxxxxxxx xxxxxxxx x xxxxxxxxx xxxx xxxxx hodnocení.
5. Xxxxx xx xxxxx, xx jsou x xxxxxxxxx nutné xxxxxxxxxx xxxxxxxxx, hodnotící xxxxxxxxx orgán účastníka xxxxx, xxx tyto xxxxxxxxx xx xxxxxxxxx xxxxx předložil, a xxxxxxxxx x xxx xxxxxxxx.
Xxxxx 365 xxx xxxxxxx x odstavci 3 xx xxxxxxx xx xxxx xxx xxx xxxxxxxx xxxxxxxxx xx dne xxxxxxxx xxxxxxxxx. Pokud xx xxxx xxxxxxxxxx xxxxxxx xxxxxxxxxxxx xxxxx xxxx xxxxxxxxxxx xxxxxxxxxx, přerušení xxxxxxxxxx xxxxxxxxxxx xxxxx:
x) |
365 xxx x xxxxxxx, že xx doplňující xxxxxxxxx xxxxxx xxxxxx, xxxxx xxxxxx xxxxxx v xxxxx xxxxxxxx 98/8/ES xxxx x xxxxx xxxxxxx xxxxxxxxxxx xxx xxxxxxxxxxx xxxxxxx směrnice; |
x) |
180 dní xx xxxxx ostatních xxxxxxxxx. |
6. Xxxxx xxxxxxxxx xxxxxxxxx orgán xxxxxx, že xxxxxxxx xxxxx xxxxxxx xxxxxx xxxx xxxx zvířat xxxx xxxxxxxxx xxxxxxxxx xxxxxxxxxxx x xxxxxxxxxxxxx účinků xxxxxxxxxx x xxxxxxxxx xxxxxxxxxx přípravků xxxxxxxxxxxx xxxxxx xxxx xxxxxxxx xxxxxx xxxxx, xxx xxxxx xxxxxxxxxxxx x xxxxxxx x xxxxxxxxx xxxxxxxxxxx xxxxx oddílu XX xxxx 3 přílohy XX xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Rady (XX) x. 1907/2006 (8) a zahrne xx xx xxxxx xxxxxx.
7. X případě xxxxxxx xx xxxxxxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxxxxx příslušný xxxxx xxx xxxxxxxxxx xxxxxxx x xxxxxxxxxx xxx xxxxxxxxxx xxxxxxxxx zprávy xxxxx xxxxxxxx 3:
x) |
předloží xxxxx agentuře xxxxx xx. 37 xxxx. 1 xxxxxxxx (XX) x. 1272/2008, jestliže 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; |
b) |
xxxxxxxxxx s agenturou, xxxxx xx xxxxxxx, xx xxxxx x xxxxxxxx xx. 5 xxxx. 1 xxxx. x) xxxx x) xxxxxxxx (EU) x. 528/2012 nebo xxxxxxxx xx. 10 xxxx. 1 xxxx. x) xxxxxxxxx xxxxxxxx jsou xxxxxxx, ale xxxxxx xxxxxxxx xxxxxx x xxxxxxx XXX xxxxxxxx (XX) x. 1907/2006 xxxx x xxxxxxx xxxxxxxx x xx. 59 xxxx. 1 xxxxxxxxx xxxxxxxx. |
Xxxxxx 7
Stanovisko xxxxxxxx
1. Tento xxxxxx xx xxxxxxx, xxxxx platí xxxxxxx x xxxxxx xxxxxxxx:
a) |
xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx zprávu xxxxx xx. 6 xxxx. 2 x xxxxxxxx xxxxxxxxx xxxxx xxxx xxxxxxx xxxxxxxxxx xxxxx čl. 6 xxxx. 7; |
x) |
xxxxx xxxx xxxxxxxxxx Komisi xxxxxx příslušného xxxxxx xxxxx xx. 14 xxxx. 4 xxxxxxxx (ES) x. 1451/2007, xxx xxxxxxxxx zprávu xxxxx nepřezkoumal Xxxxx xxxxx xxx xxxxxxxx xxxxxxxxx xxxxx xx. 15 xxxx. 4 xxxxxxxxx xxxxxxxx. |
2. Po xxxxxxx xxxxxx xxxxxxxx xxxxxxxxx x xxxxxxxx Komisi xxxxxxxxxx x xxxxxxxxx xxxxxxxxx xxxxx x xxxx přípravku xxxx xxxx xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 přílohy X xxxxxxxx (XX) x. 528/2012, xxxxxxxx obojím, x xxxxxxx xx xxxxxx xxxxxxxxxxx xxxxxxxxxxx xxxxxx.
Xxxxxxxx zahájí xxxxxxxx xxxxxxxxxx x xxxxx x xxxxxx xxxx, podle toho, xx xxxxxxx xxxxxxx:
a) |
do xxx xxxxxx xx xxxxxxx xxxxxx; |
x) |
xx lhůtě xxxxxxxxx x xxxxxxx III. |
Xxxxxxxx xxxxxxxx xxxxxxxxxx Xxxxxx xx 270 dnů xx xxxxxxxx xxxxxxxx.
Xxxxxx 8
Xxxxxx látky, xxxxx se xxxx xxxxxxxx
1. Xxx přípravě xxxxx xxxxxxxxxx podle čl. 7 xxxx. 2 agentura xxxxxxx, xxx xxxxxx látka xxxxxxx některé x xxxxxxxx xxxxxxxxx x xx. 10 xxxx. 1 xxxxxxxx (XX) x. 528/2012, x xxxx xxxxxx zmíní xx xxxx xxxxxxxxxx.
2. Xxxx jsou xxxxxxx články 66 x 67 xxxxxxxx (XX) x. 528/2012, xxxxx xxx xxxxxxxx xxxxxxxx xxx xxxxxxxxxx Xxxxxx, xxxxxxxx xxxxxxxxx x xxxxxxx látkách, xxxxx xx mají xxxxxxxx, xxxxx xxxxxxxxx 60 xxx; v xxxx xxxx xxxxx xxxxxxxxxx třetí strany xxxxxxxxx xxxxxxxxx informace xxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxxx. Xxxxxxxx obdržené xxxxxxxxx xxxxxxxx zohlední x xxxxxxxxx xxxx xxxxxxxx xxxxx stanoviska.
3. Xxxxx xx účinná látka xxxxxxxxx x xxxxxxx xxxxx x xxxxxxxx xxxxxxxxxxx x xx. 10 xxxx. 1 xxxxxxxx (XX) x. 528/2012, xxxx být xxxxxxxx za látku, xxxxx xx xx xxxxxxxx, x xxxxxxxx přijatém x xxxxxxx s čl. 89 xxxx. 1 xxxxxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxx.
Xxxxxx 9
Rozhodnutí Xxxxxx
Xx xxxxxxxx xxxxxxxxxx agentury xxxxx xx. 7 xxxx. 2 Xxxxxx xxx zbytečného xxxxxxxx připraví návrh xxxxxxxxxx pro přijetí xxxxx xx. 89 xxxx. 1, xxxx případně xxxxx xx. 28 xxxx. 1 nařízení (XX) x. 528/2012.
XXXXXXXX 3
ZMĚNY PRVKŮ XXXXXXXX XXXXXXXX
Xxxxxx 10
Připojení xxxx nahrazení účastníků xx xxxxxxxx dohodě
1. Roli xxxxxxxxx xx xxxxx xx vzájemné dohodě xxxx stávajícím xxxxxxxxxx x potenciálním xxxxxxxxxx xxxxxxx xxxx sdílet xx xxxxxxxxxxx, xx xx xxxxxxxxxxx xxxxxxxx xxxxx odvolávat xx xx xxxxxxx údaje xxxxxxxxxx xxxx xxxxxxx xxxxxxxxxx xxxxxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxxx xxx xxxxx xxxxxx xxxxxx xxxxxxxxxxx agentuře xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxxxx xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx xxx xxxxxxxx přípravky xxxxxxxxx x xxxxxx 71 xxxxxxxx (XX) č. 528/2012 (xxxx xxx „xxxxxxxx“) x&xxxx;xxxxxxxx musí xxxxxxxxx všechna xxxxxxxxx xxxxxxxx x xxxxxxxx.
3.&xxxx;&xxxx;&xxxx;Xx xxxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx 2 xxxxxxxx xxxxxxxxxxx xxxxxxxxx x&xxxx;xxxxxxxxx xxxxxxxx xx totožnosti účastníka.
4. Osoba xxxxxxx xx&xxxx;xxxxx Unie, xxxxx xxxxxxxx xxxx xxxxxxxxx xxxx se xxxxxxxxx k účastníkovi xxxxx tohoto článku, xx xxx xxxxx xxxxxx 95 xxxxxxxx (XX) x.&xxxx;528/2012 xxxxxxxxxx xx osobu, která xxxxxxxxxx xxxxxxxxxxx nebo xxxxxxxx x xxxxxxxx x xxxxxxxxxxx.
Xxxxxx 11
Xxxxxxxxxx xxxxxxxxx
1. Xx xx xx xx, xx účastník xxxxxxxxx x xxxxxx na xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx x xxxxxxxx xxxxxxxx, x těchto xxxxxxxxx:
x) |
xxxxx informoval xxxxxxxx xxxx xxxxxxxxx xxxxxxxxx xxxxx prostřednictvím xxxxxxxxx x svém xxxxxx xxxxxxxxx; |
x) |
xxxxx xxxxxxxxxxx žádost xx xxxxx xxxxxxx x xx. 3 xxxx. 2; |
c) |
xxxxx xxxx xxxxxx xxxx xxxxxxxxx xxxxx čl. 4 odst. 1, xx. 4 xxxx. 4 xxxx xx. 5 xxxx. 4; |
x) |
xxxxx xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxxxxxx xxxxxxxxx v čl. 6 xxxx. 5; |
x) |
xxxxx xxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxxxxx xxxxxx xxxx agentuře. |
2. Xxxxxxxxxx xx považuje xx xxxxxxxxx včas, xxxxx x xxxx nedojde xx xxxx, xxx xxxxxxxxx příslušný xxxxx xxxxxxxxx xxxxxxxx xxxxxx xxxxxxxxxxx orgánu podle xx. 6 odst. 4 tohoto xxxxxxxx.
Xxxxxx 12
Xxxxxxxx včasného xxxxxxxxxx
1. Xxxxx je x xxxxxxx odstoupení xxxxxxxxxx xxxxxxxxx příslušný xxxxx, xxx xxxxxx agentura, xxxxxxxxx ji xxxxxxxxx xxxxxxxxx orgán xxx xxxxxxxxxx xxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxx je x xxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxx, xxxxxxxxxxx xxxxxxxxx x xxxxxxxxx týkající xx xxxxxxxxxx účastníka.
3. Xxxxx x xxxxxxxx xxxxxxxx xxxx xxxxxxxxxx xxxxxxx účastníci xxxxxxxxxxx xxxxx xxxxxxxxx xxxxx a typu xxxxxxxxx x xxxxx xxxx xxxx xxxxxxxxx xxx xxxxxxxx xxxxxxxxx dříve převzata, xxxxxxxxx x tom xxxxxxxx xxxxxxxxxxxxxxx rejstříku Xxxxxx.
Xxxxxx 13
Nová xxxxxxxx xxxxxxxxx xxxxx
1. Xxxxx hodnocení xxxxxxxxx účinné xxxxx xxxxxxxx vyvodit xxxxxx xxxxxxxx se xxxxx, xxx xxxx xxxxxxx x xxxxxxx XX, hodnotící xxxxxxxxx xxxxx po xxxxxxxxxx x dotyčným účastníkem xxxxxxx xxxxx identitu xxxxx. Hodnotící xxxxxxxxx xxxxx x xxx informuje xxxxxxxx.
2. Xxxxxxxx v rejstříku xxxxxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx látky.
Xxxxxx 14
Převzetí role xxxxxxxxx
1. Xxxxxxxx xxxxxxxx otevřenou xxxxx k převzetí xxxx xxxxxxxxx xxx xxxxxxxxx látky x xxxx xxxxxxxxx, xxxxx xxxxxxx xxxxx z těchto xxxxxxx:
x) |
xxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxx látky x xxxx xxxxxxxxx včas xxxxxxxxxx xxxxx xxxxxx 11 x xxxxxx xxxx účastníka xxx xxxxx xxxxxxxxx xxxxxx předtím xxxxxxxx; |
b) |
xx xxxxxxx xxxx definice podle xxxxxx 13; v tomto xxxxxxx xx xxxxx týká xxxxx té xxxxx, xx xxxxxx xx vztahuje xxxxxxxxx identita v příloze II, xxx nikoliv xxxx xxxxxxxx xxxxx. |
2. Xx xxxxxxxx xxxxxx xxx xxx xxxxxxxxxx xxxxx xxxxxxxx 1 xxxx xxxxxxxxx osoba xxxxxxxxx xxxxxxxx xxx xxxxxxxxx podle xxxxxx 17.
3. Xx xxxxxxxx xxxxxx xx xxxx xxxxxx xxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxx xxxxx oznámit xxxxxxxxx xxxxx a typu xxxxxxxxx xxxxxxxxx xx xxxxx 2 xxxxxxx XX xxxxx xxxxxx 17.
Xxxxxx 15
Xxxxxxxxx látky x xxxx přípravku xxxxxxxxx pro xxxxxxxx xx xxxxxxxx xxxxxxxx
Xxxxx xxxxxxxx xxxxxxxxx, xxxxx xxxxx xx xxxxxxx xxxxxxxxxx xxxxxxxx (XX) x. 528/2012 x xx xxxxxx na trh, xxxxxxx xx stávající xxxxxx xxxxx, xxx xxxx schválena xxx xxxxxxxx do programu xxxxxxxx xxx xxxxx xxx xxxxxxxxx a xxxx xxxxxxxx xx xxxxxxx X xxxxxxxxx xxxxxxxx, xxxx xxxxx xxxxxxxx xxxx xx x xx vyrábí, xx xxxxxxx xxxxx xxxxxxxxx pro xxxxxxxx xx xxxxxxxx xxxxxxxx pro xxxxxxxxx typ xxxxxxxxx xx xxxxxxx některého x xxxxxx xxxxxx:
x) |
xxxxx xxxxxxxxx xxxxxxx xx xxx se spoléhala xx xxxxxx xxxx xxxxxxx xxxxxxxxxx vydané Xxxxxx nebo xxxxxxxxxx xxxxxxx jmenovaným x xxxxxxx x xxxxxxx 26 směrnice 98/8/XX xxxx xxxxxxx 81 xxxxxxxx (XX) č. 528/2012, xxxxx xx základě xxxxxxxxxx xxxxxxxxxxxxxx xxxxxx xxxxx uvedené pokyny xx xxxxxxxxxx x xxxxxxxxxxx, xx xxxxxxx xxx xxxxx z působnosti xxxxxxxx 98/8/XX nebo xxxxxxxx (XX) x. 528/2012, xxxx xx byl xxxxxxxxx xxx přípravku xxxxxx x přípravků, xxx xxxxx byla účinná xxxxx xxxxxxxx, x xxxxx xxxx xxxxxxx xxxxxx či xxxxxxxxxx xxxxxxxx xxxxxxxxxxx x xxxxxxxxxx xxxxxxxx xxxxx xx. 3 odst. 3 xxxxxxxx (EU) č. 528/2012 xxxx x xxxxxx, xxxxxxxxx xxxxxxxx xxxxxxxxxxxx Xxxxxx; |
x) |
xxxxx xxxxxxxxx odchylky xxx xxxxxxxxx a krmiva xxxxxxxxx x xxxxxx 6 xxxxxxxx (XX) č. 1451/2007; |
c) |
xxxxxxxx přípravek xxxxx xxxxx xxxxxxxx (XX) x. 528/2012 k xxxxxxxxx xxxx xxxxxxxxx, xxx xxxx xxxx xxxxx xxxxxxxx 98/8/XX, x xxxxxxxx xxxxx xxxxxxxxxx těchto xxxx xxxxxxxxx a obsahuje xxxxx zařazenou do programu xxxxxxxx xxx xxxxxxx xxx xxxxxxxxx, ale xxxxxx xxx xxxx. |
Xxxxxx 16
Xxxxxxxxxx x xxxxx xx oznámení
1. Xxxxxxxxxx x xxxxx oznámit xxxxx, xxxxx je způsobilá xxx zařazení do programu xxxxxxxx xxxxx článku 15, xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx xxxxxxxxx osoba, xxx xx zájem xxxxxxx xxxxxxxxx látky x xxxx xxxxxxxxx, jednomu x následujících xxxxxxxx:
x) |
Xxxxxx xxxxxxxxxx dvanáct měsíců xx xxxxxxxxxx xxxxxxxxxx xxxx xxxxxx uvedených x xx. 15 písm. a); |
x) |
xxxxxxxx nejpozději 30. xxxxx 2015 x xxxxxxxxx xxxxxxxxx x xx. 15 xxxx. x); |
x) |
Xxxxxx xxxxxxxxxx 30. xxxxx 2015 v xxxxxxxxx xxxxxxxxx x čl. 15 xxxx. x). |
2. Xxxxxxxxxx musí obsahovat xxxxxxxxxx xxxxxxxxx xxxxx x xxxx přípravku. X xxxxxxxxx xxxxxxxxx x xx. 15 xxxx. x) xxxx xxxxxxxxxx xxxxxxxxx opodstatněné xxxxxxxxxx, x xxxx vyplývá, xx xxxx xxxxxxx xxxxxxx xxxxxxxx x xxx xxxxxxx.
3. Xxxxx bylo xxxxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 xxxx. x) xxxx x) x Xxxxxx dospěje po xxxxxxxxxx x xxxxxxxxx xxxxx x závěru, že xxxxxxxx 6 není xxxxxxxxxx, x xxxxxxxx, xx xxxx splněny xxxxxxxx xxx xxxxxxxx uvedené x xx. 15 xxxx. x), xxxxxxx x xxx xxxxxxxx.
4. Xxxxx xxxx prohlášení xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 xxxx. x) xxxx xxxxx Xxxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 3, zveřejní agentura xxxx xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx s uvedením xxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx. Xxx účely xxxxxx xxxxxxxx xx xxxxxxxxxx xxxxx xx. 3x xxxx. 3 xxxxxxx xxxxxxxxxxx xxxxxxxx (XX) č. 1451/2007 xxxxxxxx xx xxxxxxxxxx xxxxx tohoto xxxxxxxx.
5. Xxxxxxxxx xxxxx, xxxxx xx xxxxx oznámit xxxxxxxxx xxxxx x typu xxxxxxxxx, xxx xxxx xxxxxx xxxxx článku 17 xx xxxxx xxxxxx xxx dne zveřejnění xxxxx xxxxxxxx 4.
6. V případech xxxxxxxxx v xx. 15 xxxx. x) x x) xx xxxxxxxxx látky x xxxx xxxxxxxxx xxxxxxxx za xxxxxxxxx účastníkem x xxxx xxxxxxxxx x xxxxxxx xxxxxxxx, xxxxx jsou xxxxxxx xxxx podmínky:
a) |
xxxxxxxxx xxxxxx xxxxx xx xxx xxxxxxxx xx xxxxxxxx xxxxxxxx; |
x) |
xxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx státu pro xxxxxxxxxx účinnou xxxxx xxx xxxxxxxx xxxxxxx xxxxx, xxxxx xxxx xxxxxxxx xxx xxxxxxxxx xxxx xxxxxxxxx; |
c) |
účastník, xxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxxx, xxxxx, xx xx xxxxx o podporu xxxx kombinace xxxxx x xxxx xxxxxxxxx. |
Xxxxxx 17
Xxxxxx oznámení
1. Xxxxxxxx xxxxx čl. 14 xxxx. 2 x 3 xxxx xx. 16 odst. 5 se xxxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxxxxx musí být xxxxxxxxxx xx xxxxxxx XXXXXX. Xxxx obsahovat xxxxx uvedené x xxxxxxx X.
3. Xxxxx xxxx x xxxxxxx XX xxx xxxxxxxx xxxxxxx xxxxx xxxxxx xxxxxxxxx příslušný xxxxx, xxxxxxxxx xxxxxxxxxxx agenturu x xxxxx xxx xxxxxxxxx xxxxxxxxxxx xxxxxx, xxxxx xx xxxxxxxx v souladu x xxxxxxx 81 xxxxxxxx (XX) x. 528/2012, a poskytne xxxxxxx xxxxxxxxx xxxxxxxxxxx, xx xxxxxxxxx xxxxx souhlasí x xxx, xx xxxxxxxxxxx xxxxxxx.
4. Xx xxxxxxxx xxxxxxxx x tom xxxxxxx xxxxxxxx Xxxxxx a xxxxxxxxxxxx xxxxxxxxx o poplatcích xxxxxxxxx xxxxx xxxxxxxx (XX) č. 564/2013. Xxxxxxxx xxxxxxxxxxx neuhradí poplatky xx 30 dnů xx přijetí xxxxxxx xxxxxxxxx, xxxxxxxx oznámení xxxxxxx x uvědomí x xxx xxxxxxxxxxxx x Komisi.
5. Po xxxxxxxx xxxxxxxx xxxxxxxx do 30 xxx ověří, xxx xxxxxxxx xxxxxxxx xxxxxxxxxx uvedeným x xxxxxxxx 2. Xxxxx xxxxxxxx xxxxx xxxxxxxxxx xxxxxxxxxx, poskytne agentura xxxxxxxxxxxx xxxxx x xxxxx 30 xxx, xxx xxx xxxxxxxx xxxxxxx nebo xxxxxxx. Xx xxxxxxxx xxxx 30xxxxx xxxxx agentura xx 30 xxx xxx xxxxxxxx, xx xxxxxxxx vyhovuje xxxxxxxxxx xxxxxxxx 2, xxxx xxxxxxxx zamítne, a xxx rozhodnutí sdělí xxxxxxxxxxxx a Xxxxxx.
6. X xxxxxxx x článkem 77 xxxxxxxx (XX) x. 528/2012 proti xxxxxxxxxxx agentury podle xxxxxxxx 4 nebo 5 xxxxx xxxxxxx xxxxxxxxxx.
7. Xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxx xxxxxxxx 5:
x) |
x xxxxxxx, xx xxxx xxxxxxxx xxxxxxxxxx podle xx. 14 xxxx. 2 xxxx 3, xxxxxxxx neprodleně xxxxxxxxxxx informace x xxxxxxxxx týkající xx xxxxxxxxxx xxxxxxxxx x xxxxxxxx identity xxxxx; |
x) |
x xxxxxxx, že oznámení bylo xxxxxxxxxx xxxxx xx. 16 xxxx. 5, xxxxxxxx neprodleně xxxxxxxxx Komisi, xx xxxxxxxxxx xxxx vyhověno. |
Xxxxxx 18
Xxxxxxxx xx xxxxxxxx přezkumu
Pokud xx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxxx xx xxxxxxxxx x xxxxxxx x xx. 16 xxxx. 6 nebo xxxxx xxxxxxxx informuje Xxxxxx x xxxxxxxx xxxxxxxxx x souladu s čl. 17 xxxx. 7 písm. b), zařadí Xxxxxx xxxxxxxxx látky x xxxx přípravku xx xxxxxxxx xxxxxxxx.
Xxxxxx 19
Xxxxxxxxx x xxxxxxx, xxxxx xxxxxx xxxxxx podporovány x xxxxx xxxxxxxx xxxxxxxx
Xxxxx xxxxxx ve lhůtě xxxxxxxxx x xx. 16 odst. 5 xxxxxxxx xxxxx xxxxxxxx xxxx xxxxx xxxx oznámení xxxxxxx ve xxxxxxxx xxxxxx xxxxxxx x xxxxxxxx xxxxxxxxx agenturou xxxxx xx. 17 odst. 4 xxxx 5, xxxxxxxx o tom xxxxxxxxx xxxxxxx xxxxx xxxxxxxxxxxxxxx rejstříku x xxxxxxxx xxxx informaci xxxxxxxxxxxxx xxxxxx.
Xxxxxx 20
Rozhodnutí Xxxxxx x xxxxxxx, xxxxx xxxxxx nadále podporovány x rámci xxxxxxxx xxxxxxxx
Xxxxxx xxxxxxxx xxxxx xxxxxxxxxx x xxxxxxxxxxx xxxxx xx. 89 xxxx. 1 xxxxxxx pododstavce xxxxxxxx (XX) č. 528/2012 x xxxxxx xxxxxxxxx:
x) |
xxxxx xxxxxxxx informuje Xxxxxx o včasném odstoupení xxxxxxxxx xxxxx xx. 12 xxxx. 3 tohoto xxxxxxxx; |
b) |
xxxxx xxxxx xxxxx nepodala xxxxxxxx xx xxxxxxx xxxxxxxxxxx x xx. 14 odst. 2 xxxx 3 tohoto xxxxxxxx xxxx xxxxx xxxx xxxxxxxx xxxxxxxxxx x xxxxxxxxx xxxxx čl. 17 odst. 4 xxxx 5; |
x) |
xxxxx xxxx xxxxxxxx předloženo xx xxxxx xxxxxxxxx v čl. 14 xxxx. 2 xxxx 3 xxxxxx xxxxxxxx x xxxx xxxxxxxx xxxxxxxxx podle xx. 17 xxxx. 5 tohoto xxxxxxxx, xxx xxxxxxxx xxxxx x xxxxxxxx zahrnuje pouze xxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX xxxxxx xxxxxxxx. |
V případě xxxxxxxx v prvním pododstavci xxxx. c) xx xxxxx rozhodnutí x xxxxxxxxxxx vztahuje xx xxxxxx xxxxx, na kterou xx vztahuje stávající xxxxxxxx x xxxxxxx XX tohoto xxxxxxxx, xxxxx xxxxxx xxxxxxxx nebo jakékoli xxxxxxxxxx o xxxxxxxxx.
KAPITOLA 4
PŘECHODNÁ XXXXXXXX
Xxxxxx 21
Xxxxxxxxx opatření xxx xxxxx xxxxxxx v článku 15
1. Členský xxxx xxxx pokračovat x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx xxxx praxe xxxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxxxx xxxxxxxxxx xxxxxxxxx, který xxxxxxx xx xxxxxxxxx xxxxxx xxxxx xxxxxxx x xx. 15 xxxx. x) x x), xxxx xxxxx xxxxxxxx xxxx x xx vzniká. X xxxxxx xxxxxxxxx:
x) |
xxxxx být xxxxxxxx xxxxxxxxx nadále xxxxxxx na trh x&xxxx;xxxxxxx xx&xxxx;24 xxxxxx po xxxx xxxxxx xxxxxx xxxxxxxx v platnost; |
b) |
stávající xxxxxx xxxxxxxxxx přípravku xxxxx xxx dále využívány xx&xxxx;30 xxxxxx po xxx xxxxxx tohoto xxxxxxxx x&xxxx;xxxxxxxx. |
2.&xxxx;&xxxx;&xxxx;Xxxxxxx stát xxxx xxxxxxxxxx v uplatňování xxxxx xxxxxxxxxxx systému xxxx praxe xxxxxxxx xx&xxxx;xxx a používání xxxxxxxxxx xxxxxxxxx, který xxxxxxx xx stávající xxxxxx xxxxx xxxxxxx x xx. 15 písm. x), tuto látku xxxxxxxx nebo x xx xxxxxx. X xxxxxx xxxxxxxxx:
x) |
xxxxx xxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;24 xxxxxx po xx z dále xxxxxxxxx xxxxxxxx, xxxxx xxxxxxx xxxxxxx:
|
x) |
xxxxxxxxx xxxxxx biocidního xxxxxxxxx xxxxx být dále xxxxxxxxx xx&xxxx;30 měsíců xx xx z xxxx uvedených xxxxxxxx, xxxxx xxxxxxx xxxxxxx:
|
3.&xxxx;&xxxx;&xxxx;Xxxxxxx stát xxxx xxxxxxxxxx v uplatňování xxxxx xxxxxxxxxxx xxxxxxx nebo xxxxx xxxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxxxx xxxxxxxxxx přípravku, xxxxx xxxxxxx xx xxxxxxxxx xxxxxx látky xxxxxxxxxx xxxxxxxxx xxxxx xx. 16 xxxx. 4 xxx xxxxxxxxx xxx xxxxxxx, xxxx xxxxx xxxxxxxx xxxx x ní xxxxxx. X xxxxxx xxxxxxxxx:
x) |
xxxxx xxx biocidní xxxxxxxxx xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx od dvanácti měsíců xx xxxx, xxx xxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxxxxxxx podle článku 19 x |
x) |
xxxxxxxxx xxxxxx xxxxxxxxxx přípravku mohou xxx xxxx využívány xx&xxxx;xxxxxxxx xxxxxx xx xxxx uvedeného xxxxxxxxxx. |
Xxxxxx 22
Nezbytná použití
1. Aniž xx xxxxxx čl. 55 xxxx. 1 xxxxxxxx (XX) x. 528/2012, do osmnácti xxxxxx xx xxxx xxxxxxxxxx x xxxxxxxxxxx xxxxxxxxx xxxxxx xxxxx, xxxxx členský xxxx xxxxxxxx xxxx xxxxxxxxx xxxxxxx látku xx xxxxxxxxx z důvodů xxxxxxxxx x xx. 5 xxxx. 2 xxxxxx xxxxxxxxxxx xxxx. x) xxxx x) nařízení (EU) x. 528/2012, xxxxx členský xxxx může xxxxxxxxx Xxxxxx odůvodněnou žádost x xxxxxxxx xx xx. 89 odst. 2 xxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx xxxxxxx xxxx xxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxx prostřednictvím xxxxxxxxx. Xxxxx xxxxxx obsahuje xxxxxxx xxxxxxxxx, xxxxxxxx xxxxxxx xxxx xxxx xxxxxxx xxxxxxxxx xxxxxxxxx xxxxx.
3. Xxxxxxxx zveřejní žádost xxxx xxxxxxxx xxxxxxxxxx xxxxx xxxxxxxxxxxxxx xxxxxxxxxx. Xxxxxxx xxxxx xxxx xxxx osoby xxxxx xxxxx xxxxxxxxxx xx xxxxx 60 xxx po xxxxxxxxxx.
4. Xx xxxxxxx xxxxxxxxxx xxxxxxxxxx xxxx Komise xxxxxxx xxxxxxxx od čl. 89 xxxx. 2 xxxxxxx xxxxxxxxxxx xxxxxxxx (XX) č. 528/2012, xxxxx umožní xxxxxx xxxxxxxx přípravky, xxx xxxxxxxxx z xxxx xxxxx, obsahují xx xxxx x xx xxxxxxxx, na xxx xxxxxxxxxx xxxxxxxxx xxxxx x xxxxxxxx xx v daném xxxxxxxx xxxxx x xxxxxxx x xxxxxxxxxxxxxx xxxxxxxx předpisy x x xxxxxxxx podmínek odstavce 5 x xxxxxxxxx xxxxxxx xxxxxxxx xxxxxxxxx Xxxxxx.
5. Členský xxxx, jemuž je xxxxxxxx xxxxxxxx:
x) |
zajistí, xx xxxxx xxxxxxxxx xxxx omezeno xx xxxxxx případy a xxxxxxx xxxx, kdy xxxx xxxxxx xxxxxxxx xxxxxxxx 1; |
x) |
xxxxxx xxxxxx xxxxxxxx xx xxxxxxxx xxxxx, xxx xxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxxxx, xxxxxx nebo xxxxxxxxx prostředí; |
c) |
xxxxxxx, aby xx xxxxxxx xxxxxxxxxxxx xxxxxx nebo xxx xxxx xxxx xxxx xxxxxxxxx platnosti xxxxxxxx xxxxxxxxxx xxxxxx x xxxxxxxxx xxxxxx látky v souladu xxxxxxx 7 nařízení (XX) x. 528/2012. |
KAPITOLA 5
XXXXXXXXX XXXXXXXXXX
Xxxxxx 23
Xxxxxxx
Xxxxxxx xx xxxxxxxx (XX) x. 1451/2007.
Xxxxxx xx xxxxxxx xxxxxxxx xx xxxxxxxx xx xxxxxx xx xxxx xxxxxxxx.
Xxxxxx 24
Xxxxx v xxxxxxxx
Xxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxxxxxx xxxx xx vyhlášení x Úředním xxxxxxxx Xxxxxxxx xxxx.
Xxxx xxxxxxxx xx xxxxxxx x xxxxx xxxxxxx a xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx xxxxxxx.
X Xxxxxxx xxx 4. xxxxx 2014.
Xx Xxxxxx
xxxxxxxx
Xxxx Manuel XXXXXXX
(1)&xxxx;&xxxx;Xx. věst. X 167, 27.6.2012, s. 1.
(2) Nařízení Komise (XX) x. 1451/2007 ze xxx 4. xxxxxxxx 2007 o xxxxx xxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxx x xx. 16 xxxx. 2 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx 98/8/XX x uvádění xxxxxxxxxx xxxxxxxxx na xxx (Úř. xxxx. X 325, 11.12.2007, x. 3).
(3)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Rady 98/8/ES xx xxx 16. xxxxx 1998 x xxxxxxx xxxxxxxxxx xxxxxxxxx xx xxx (Xx. xxxx. X 123, 24.4.1998, x. 1).
(4) Rozsudek Soudního dvora (xxxxxxx xxxxxx) ze xxx 1. xxxxxx 2012 (xxxxxx o xxxxxxxxxx o xxxxxxxxx xxxxxx: Landgericht Hamburg – Xxxxxxx) – Xöxx XxxX xxxxx Xxxxx XxxX (uvádění xxxxxxxxxx přípravků xx xxx – xxxxxxxx 98/8/XX – xx. 2 xxxx. 1 xxxx. a) – xxxxx „xxxxxxxx přípravky“ – xxxxxxxxx, který xxxxxxxxx xxxxxxxxxx škodlivých xxxxxxxxx, xxxx xx xxxx, xxxxxxxx xxxx xxxxxxxxxxx), X-420/10.
(5) Prováděcí xxxxxxxx Komise (XX) x.&xxxx;88/2014 xx xxx 31. ledna 2014, xxxxxx se stanoví xxxxxx pro xxxxx xxxxxxx I nařízení Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;528/2012 x&xxxx;xxxxxxxx biocidních xxxxxxxxx xx xxx x&xxxx;xxxxxx xxxxxxxxx (Xx. xxxx. X 32, 1.2.2014, x. 3).
(6)&xxxx;&xxxx;Xxxxxxxx Evropského xxxxxxxxxx x Rady (XX) x. 1272/2008 xx xxx 16. prosince 2008 x xxxxxxxxxxx, xxxxxxxxxx a balení xxxxx x směsí, x xxxxx a xxxxxxx xxxxxxx 67/548/XXX x 1999/45/XX x x xxxxx xxxxxxxx (XX) č. 1907/2006 (Xx. xxxx. X&xxxx;353, 31.12.2008, x. 1).
(7)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Xxxxxx (XX) x.&xxxx;564/2013 xx xxx 18.&xxxx;xxxxxx 2013 x&xxxx;xxxxxxxxxx a platbách xxxxxxxxx Xxxxxxxx xxxxxxxx xxx xxxxxxxx xxxxx podle xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;528/2012 x&xxxx;xxxxxxxx xxxxxxxxxx xxxxxxxxx xx trh a jejich xxxxxxxxx (Úř. věst. L 167, 19.6.2013, x. 17).
(8)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx parlamentu x Xxxx (ES) x. 1907/2006 ze xxx 18. prosince 2006 x xxxxxxxxxx, xxxxxxxxx, xxxxxxxxxx x xxxxxxxxx chemických xxxxx, x xxxxxxx Evropské xxxxxxxx pro xxxxxxxx xxxxx, x změně xxxxxxxx 1999/45/ES x x xxxxxxx xxxxxxxx Xxxx (XXX) č. 793/93, xxxxxxxx Komise (ES) x. 1488/94, xxxxxxxx Xxxx 76/769/EHS a 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
Informace požadované xxx xxxxxxxx xxxxx xxxxxx 17
Xxxxxxxx xxxxx xxxxxx 17 xxxxxxxx xxxx xxxxxxxxx:
1) |
xxxxx, xx xxxxx xx xxxxxxxxx xxxxxxx xxxxxx xx xxxxxx čl. 3 xxxx. 1 písm. d) nařízení (XX) č. 528/2012; |
2) |
xxxxx x xxxx/xxxxxx přípravku, xx xxxxx/x xx oznámení xxxxxxxx; |
3) |
xxxxxxxxx x xxxxx studiích, xxxxx xxxx zadány xxx xxxxx xxxxxxx x xxxxxxxxx či zařazení xx xxxxxxx X xxxxxxxx (XX) x. 528/2012, xxxxx x xxxxxxxxx xxxxx xxxxxx dokončení; |
4) |
informace xxxxxxx v xxxxxxxx
|
5) |
xxxxx xxxx xxxx oznámení xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 xxxx. x), xxxxx, že látka xxxx xx xxxx xxxx účinná xxxxx xxxxxxxxxx přípravku xxxxxxxxxxx xx xxxxxxxxxxx xxxx xxxxxxxxx x xxx oznámení xxxx xxxxxxxxxx rozhodnutí xxxx xxxxxx xxxxxxxxx xx xxxxxxxx písmenu. |
XXXXXXX XX
XXXXXXXXX XXXXX X XXXX XXXXXXXXX XXXXXXXX XX XXXXXXXX XXXXXXXX DNE 4. XXXXX 2014
XXXX 1
Xxxxxxxxx účinné látky x xxxx xxxxxxxxx xxxxxxxxxxx xx dni 4. xxxxx 2014, x xxxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxxxxxx xxx xxxx, xxxxx xxxx xxxxxxxx uvedeny x xxxxxxxxx 1017 x 1019.
Xxxxx xxxxxxx |
Xxxxx látky |
Xxxxxxx xxxx xxxxxxxxx |
Xxxxx ES |
Číslo CAS |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
17 |
18 |
19 |
21 |
22 |
1 |
formaldehyd |
DE |
200-001-8 |
50-00-0 |
|
x |
x |
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x |
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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x |
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9 |
xxxxxxxx |
XX |
200-143-0 |
52-51-7 |
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x |
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x |
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x |
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x |
x |
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x |
29 |
xxxxxxxxxxx |
XX |
200-431-6 |
59-50-7 |
x |
x |
x |
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x |
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x |
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x |
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36 |
xxxxxxx |
XX |
200-578-6 |
64-17-5 |
x |
x |
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x |
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37 |
xxxxxxxx mravenčí |
XX |
200-579-1 |
64-18-6 |
|
x |
x |
x |
x |
x |
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x |
x |
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40 |
xxxxxx-2-xx |
DE |
200-661-7 |
67-63-0 |
x |
x |
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x |
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43 |
xxxxxxxx xxxxxxxxxx |
XX |
200-712-3 |
69-72-7 |
|
x |
x |
x |
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45 |
propan-1-ol |
XX |
200-746-9 |
71-23-8 |
x |
x |
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x |
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52 |
xxxxxxxxxxx |
X |
200-849-9 |
75-21-8 |
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x |
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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 |
XX |
201-180-5 |
79-14-1 |
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x |
x |
x |
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70 |
xxxxxxxx xxxxxxxxxxxx |
XX |
201-186-8 |
79-21-0 |
x |
x |
x |
x |
x |
x |
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x |
x |
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71 |
X-(+)-xxxxxx kyselina |
XX |
201-196-2 |
79-33-4 |
|
x |
x |
x |
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x |
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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) |
XX |
201-501-9 |
83-79-4 |
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x |
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85 |
xxxxxxxxx |
UK |
201-782-8 |
87-90-1 |
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x |
x |
x |
x |
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x |
x |
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92 |
xxxxxxx-2-xx |
ES |
201-993-5 |
90-43-7 |
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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113 |
cinnamaldehyd/3-fenylprop-2-enal (xxxxxxxxxxxxx) |
XX |
203-213-9 |
104-55-2 |
|
x |
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117 |
xxxxxxxx |
XX |
203-377-1 |
106-24-1 |
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x |
x |
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122 |
xxxxxxx |
XX |
203-474-9 |
107-22-2 |
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x |
x |
x |
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133 |
xxxx-2,4-xxxxxxx xxxxxxxx (kyselina xxxxxxx) |
XX |
203-768-7 |
110-44-1 |
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x |
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136 |
xxxxxxxx (glutaraldehyd) |
FI |
203-856-5 |
111-30-8 |
|
x |
x |
x |
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x |
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x |
x |
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154 |
xxxxxxxxx |
N |
204-385-8 |
120-32-1 |
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x |
x |
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171 |
2-xxxxxxxxxxx-1-xx |
XX |
204-589-7 |
122-99-6 |
x |
x |
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x |
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x |
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x |
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172 |
xxxxxxxxxxxxxxx-xxxxxxx/1-xxxxxxxxxxxxxxxx-1-xxx-xxxxxxx |
XX |
204-593-9 |
123-03-5 |
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x |
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179 |
oxid xxxxxxxx |
FR |
204-696-9 |
124-38-9 |
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x |
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180 |
(xxxxxxx-xxxxxxxxx) – xxxxxxx-xxxxxxxxxxxxxxx |
PT |
204-708-2 |
124-65-2 |
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x |
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185 |
tosylchloramid, xxxxx xxx (xxxxx xxx 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 |
xxxxxx-xxxxxxxxxxxxxxxxxxxxxx |
UK |
204-875-1 |
128-03-0 |
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x |
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x |
x |
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188 |
xxxxxxx-xxxxxxxxxxxxxxxxxxxxxx |
UK |
204-876-7 |
128-04-1 |
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x |
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x |
x |
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195 |
xxxxxxx-xxxxxxx-2-xxxx |
XX |
205-055-6 |
132-27-4 |
x |
x |
x |
x |
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x |
x |
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x |
x |
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x |
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198 |
X-[(xxxxxxxxxxxxxx)xxxxxxxx]xxxxxxxx (xxxxxx) |
XX |
205-088-6 |
133-07-3 |
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x |
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x |
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206 |
xxxxxx |
XX |
205-286-2 |
137-26-8 |
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x |
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210 |
xxxxxx-xxxxxxx |
XX |
205-293-0 |
137-42-8 |
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x |
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x |
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227 |
2-(xxxxxxx-4-xx)xxxxxxxxxxxx (xxxxxxxxxxxx) |
ES |
205-725-8 |
148-79-8 |
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x |
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x |
x |
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235 |
xxxxxx |
DK |
206-354-4 |
330-54-1 |
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x |
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x |
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239 |
xxxxxxxxxxxxx |
XX |
206-992-3 |
420-04-2 |
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x |
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x |
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253 |
xxxxxxxxxx-3,5-xxxxxxxx-1,3,5-xxxxxxxxxx-2-xxxxx (dazomet) |
XX |
208-576-7 |
533-74-4 |
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x |
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x |
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279 |
X-[(xxxxxxxxxxxxxxxxxx)xxxxxxxx]-X′,X′-xxxxxxxx-X-(4-xxxxxxxxxxx)xxxxxxxxxx (xxxxxxxxxxxx) |
XX |
211-986-9 |
731-27-1 |
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x |
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x |
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283 |
xxxxxxxxx |
XX |
212-950-5 |
886-50-0 |
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x |
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x |
x |
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288 |
X-[(xxxxxxxxxxxxxxxxxx)xxxxxxxx]-X-xxxxx-X′,X′-xxxxxxxxxxxxxxxx (xxxxxxxxxxxxx) |
XX |
214-118-7 |
1085-98-9 |
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x |
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x |
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289 |
xxxxxxxxxxxx xxxxx |
XX |
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 vápenatý/hydratované vápno/hašené 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 |
|
315 |
butan-2-on-peroxid |
HU |
215-661-2 |
1338-23-4 |
x |
x |
|
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321 |
monolinuron |
XX |
217-129-5 |
1746-81-2 |
|
x |
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330 |
X-(3-xxxxxxxxxxx)-X-xxxxxxxxxxxxx-1,3-xxxxxx (xxxxxx) |
XX |
219-145-8 |
2372-82-9 |
|
x |
x |
x |
|
x |
|
x |
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x |
x |
x |
|
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336 |
N,N′-dimethyl-2,2′-disulfandiyldibenzamid (XXXXX) |
XX |
219-768-5 |
2527-58-4 |
|
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x |
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339 |
1,2-xxxxxxxxxxxxxxx-3(2X)-xx (XXX) |
XX |
220-120-9 |
2634-33-5 |
|
x |
|
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x |
|
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x |
|
x |
x |
x |
|
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|
341 |
2-methyltetrahydroisothiazol-3(2H)-on (MIT) |
XX |
220-239-6 |
2682-20-4 |
|
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|
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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) |
PL |
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)) |
PL |
222-720-6 |
3586-55-8 |
|
x |
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x |
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x |
x |
x |
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365 |
xxxxxxx-2-xxxxx-1-xxxx, xxxxx xxx (xxxxxxxxx xxxxx) |
XX |
223-296-5 |
3811-73-2 |
|
x |
x |
|
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x |
x |
|
x |
x |
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x |
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|
368 |
1-(3-xxxxxxxxxx)-3,5,7-xxxxxx-1-xxxxxxxxxxxxxxx-xxxxxxx (XXXX) |
XX |
223-805-0 |
4080-31-3 |
|
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x |
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x |
x |
|
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|
377 |
1,3,5-xxxx(2-xxxxxxxxxxxx)xxxxxxxxx-1,3,5-xxxxxxx (HHT) |
XX |
225-208-0 |
4719-04-4 |
|
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x |
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x |
x |
x |
|
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|
382 |
1,3,4,6-xxxxxxxx(xxxxxxxxxxxxx)xxxxxxxxxxxxxxxx[4,5-x]xxxxxxxx-2,5-xxxx (XXXX) |
XX |
226-408-0 |
5395-50-6 |
|
x |
|
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|
x |
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x |
x |
x |
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387 |
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) |
XX |
230-525-2 |
7173-51-5 |
x |
x |
x |
x |
|
x |
|
x |
|
x |
x |
x |
|
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401 |
xxxxxxx |
XX |
231-131-3 |
7440-22-4 |
|
x |
|
x |
x |
|
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x |
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403 |
měď |
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 sodný |
XX |
231-599-9 |
7647-15-6 |
|
x |
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x |
x |
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432 |
xxxxxxxx xxxxx |
XX |
231-668-3 |
7681-52-9 |
x |
x |
x |
x |
x |
|
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x |
x |
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434 |
xxxxxxxxxxxx |
XX |
231-711-6 |
7696-12-0 |
|
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x |
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439 |
xxxxxxx xxxxxx |
XX |
231-765-0 |
7722-84-1 |
x |
x |
x |
x |
x |
x |
|
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x |
x |
|
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444 |
7x-xxxxxxxxxxxx-1X,3X,5X-xxxxxxx[3,4-x]xxxxxx (XXXX) |
PL |
231-810-4 |
7747-35-5 |
|
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|
x |
|
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x |
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|
450 |
dusičnan xxxxxxxx |
XX |
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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|
455 |
xxxxxxxx vápenatý |
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 |
|
|
x |
|
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x |
|
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|
458 |
xxxxx xxxxxx |
UK |
231-984-1 |
7783-20-2 |
|
|
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|
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x |
x |
|
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|
473 |
pyrethriny x xxxxxxxxxxx |
XX |
232-319-8 |
8003-34-7 |
|
|
|
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|
x |
x |
|
|
491 |
xxxx xxxxxxxxxx |
PT |
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 |
|
|
|
|
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|
x |
|
x |
x |
|
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|
|
|
|
|
515 |
xxxxxx amonný |
XX |
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 |
dodecylguanidin-monohydrochlorid |
XX |
237-030-0 |
13590-97-1 |
|
|
|
|
|
x |
|
|
|
|
x |
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
531 |
(xxxxxxxxx)xxxxxxxx |
XX |
238-588-8 |
14548-60-8 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
534 |
xxx(1-xxxxxxxxxxxxxx-2(1X)-xxxxxxxx-X,X)xxxxxxx komplex (xxxxxxxxx xxxx) |
XX |
238-984-0 |
14915-37-8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
541 |
natrium-4-chlor-3-methylfenolát |
XX |
239-825-8 |
15733-22-9 |
x |
x |
x |
|
|
x |
|
|
x |
|
|
|
x |
|
|
|
|
|
550 |
5,5′-xxx(4-xxxxxxxxxx)-1,1′-(xxxxx-1,6-xxxx)xxx(xxxxxxxx)-xxx(x-xxxxxxxx) (XXXX) |
PT |
242-354-0 |
18472-51-0 |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
554 |
4-[(xxxxxxxxxxx)xxxxxxxx]-1-xxxxxxxxxxxx |
XX |
243-468-3 |
20018-09-1 |
|
|
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|
|
559 |
[(benzothiazol-2-yl)sulfanyl]methyl-thiokyanát (XXXXX) |
X |
244-445-0 |
21564-17-0 |
|
|
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
|
|
562 |
[2-xxxxxx-4-xxx-3-(xxxx-2-xx-1-xx)xxxxxxxxx-2-xx-1-xx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (xxxxxxxxxxx) |
XX |
245-387-9 |
23031-36-9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
563 |
xxxxxx-(X,X)-xxxx-2,4-xxxxxxx (xxxxxx xxxxxxxx) |
XX |
246-376-1 |
24634-61-5 |
|
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
|
566 |
α, α′,α′′-xxxxxxxxxxxxxxxxxx-1,3,5-xxxxxxx-1,3,5-xxxxxxxxxx (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 |
XX |
248-595-8 |
27668-52-6 |
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
578 |
X2-xxxx-xxxxx-X4-xxxxxxxxxxx-6-(xxxxxxxxxxxxxx)-1,3,5-xxxxxxx-2,4-xxxxxx (xxxxxxxx) |
XX |
248-872-3 |
28159-98-0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
588 |
xxxxxxxxx-5,5-xxxxxxxxxxxxxxxxxxxx-2,4-xxxx (XXXXX/xxxxxxxxxxxxxxxxxxxxxxxxxx) |
XX |
251-171-5 |
32718-18-6 |
|
x |
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
590 |
3-(4-xxxxxxxxxxxxxx)-1,1-xxxxxxxxxxxxxxxx/xxxxxxxxxxx |
XX |
251-835-4 |
34123-59-6 |
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
|
|
|
|
597 |
1-[2-(xxxxxxxx)-2-(2,4-xxxxxxxxxxxx)xxxxx]xxxxxxxx (xxxxxxxx) |
DE |
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 |
oxid 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 (cyfenothrin) |
XX |
254-484-5 |
39515-40-7 |
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x |
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608 |
dimethyl(tetradecyl)[3-(trimethoxysilyl)propyl]amonium-chlorid |
PL |
255-451-8 |
41591-87-1 |
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x |
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609 |
cis- a xxxxx-x-xxxxxxx-3,8-xxxx (směs) (xxxxxxxxxx) |
XX |
255-953-7 |
42822-86-6 |
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x |
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614 |
(XX)-α-xxxxx-3-xxxxxxxxxxxx-(1XX)-xxx,xxxxx-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
257-842-9 |
52315-07-8 |
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x |
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615 |
3-xxxxxxxxxxxx(1XX,3XX;1XX,3XX)-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (permethrin) |
XX |
258-067-9 |
52645-53-1 |
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x |
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x |
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618 |
[1-xxxxxxx-2-xxxxxxxxxx-2-xx-1-xx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (xxxxxxxxxx) |
BE |
259-154-4 |
54406-48-3 |
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x |
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619 |
3-jodprop-2-yn-1-yl-N-butylkarbamát (XXXX) |
XX |
259-627-5 |
55406-53-6 |
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x |
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x |
x |
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x |
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620 |
xxxxxxxx(xxxxxxxxxxxxx)xxxxxxxxx-xxxxxx (2:1) (XXXX) |
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-dichlorfenyl)-4-propyl- 1,3-xxxxxxxx-2-xx]xxxxxx}-1X-1,2,4-xxxxxxx (xxxxxxxxxxxx) |
FI |
262-104-4 |
60207-90-1 |
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x |
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635 |
xxxxxxxxxxxxxxxxxxxxxxxxxxxxx kokosového xxxxx (ATMAC/TMAC) |
XX |
263-038-9 |
61789-18-2 |
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x |
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648 |
4,5-xxxxxxx-2-xxxxxxxxxxxxxxx-3(2X)-xx (4,5-xxxxxxx- 2-xxxxx-2X-xxxxxxxxxx-3-xx (XXXXX)) |
X |
264-843-8 |
64359-81-5 |
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x |
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x |
x |
x |
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649 |
1-(2-xxxxxxxxxxx)-3-[(xxxxxxxxxxxxxxx)xxxxx]xxxxxxxx (triflumuron) |
XX |
264-980-3 |
64628-44-0 |
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x |
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656 |
xxx(5-xxxxxxxxxxxxxxxx-3-xx)xxxxxx (xxxxxxxxxx/XXX) |
XX |
266-235-8 |
66204-44-2 |
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x |
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x |
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x |
x |
x |
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657 |
6-(xxxxxxxxxxxxxxxx)-1,3,5-xxxxxxx-2,4-xxxxxx (xxxxxxxxx) |
XX |
266-257-8 |
66215-27-8 |
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x |
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666 |
[(3-fenoxy-4-fluorfenyl)kyanmethyl]-3-(2,2-dichlorvinyl)-2,2-dimethylcyklopropan-1-karboxylát (xxxxxxxxxx) |
XX |
269-855-7 |
68359-37-5 |
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x |
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667 |
xxxxx(X12-18)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXX (X12-18)) |
IT |
269-919-4 |
68391-01-5 |
x |
x |
x |
x |
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x |
x |
x |
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x |
671 |
alkyl(C12-16)dimethylbenzylammoniumchlorid (ADBAC/BKC (X12-X16)) |
XX |
270-325-2 |
68424-85-1 |
x |
x |
x |
x |
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x |
x |
x |
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x |
673 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxxx (XXXX) (X8-10) |
IT |
270-331-5 |
68424-95-3 |
x |
x |
x |
x |
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x |
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x |
x |
x |
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690 |
xxxxx(X12-X18)xxxxxx(xxxxxxxx)xxxxxxxx xxxx 1,1-dioxo-1λ-1,2-benzoisothiazol-3(2H)-onu (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 |
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 hexahydrát (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 |
alkyl(C12-C14)ethylbenzylammoniumchlorid (XXXXXX (X12-X14)) |
XX |
287-090-7 |
85409-23-0 |
x |
x |
x |
x |
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x |
x |
x |
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x |
731 |
xxxxxxxxx stračkolistá, Chrysanthemum xxxxxxxxxxxxxxxx, výtažek |
XX |
289-699-3 |
89997-63-7 |
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x |
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744 |
levandule 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 xxxxxxxx a X-xxxxx(X12-X14)xxxxxx-1,2-xxxxxxx (glukoprotamin) |
XX |
403-950-8 |
164907-72-6 |
|
x |
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x |
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785 |
6-ftalimidoperoxyhexanová xxxxxxxx (XXX) |
XX |
410-850-8 |
128275-31-0 |
x |
x |
x |
x |
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791 |
2-xxxxx-1,2-xxxxxxxxxxxx-3(2X)-xx (XXXX) |
XX |
420-590-7 |
4299-07-4 |
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x |
x |
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x |
x |
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x |
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792 |
komplex tetrachlordekaoxidu (XXXX) |
XX |
420-970-2 |
92047-76-2 |
x |
x |
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x |
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811 |
xxxxxxxxxxxxxxxxxxx stříbrno-sodno-zirkoničitý |
XX |
422-570-3 |
265647-11-8 |
x |
x |
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x |
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x |
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x |
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794 |
xxx-xxxxx-2,2-(2-xxxxxxxxxxxx)xxxxxxxxx-1-xxxxxxxxxx (ikaridin) |
XX |
423-210-8 |
119515-38-7 |
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x |
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797 |
1-((X)-3-xxxxxxxxxx)-3,5,7-xxxxxx-1-xxxxxxxxxxxxxxxxxxxxxx (xxx-XXXX) |
XX |
426-020-3 |
51229-78-8 |
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x |
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x |
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800 |
{[2,5-xxxxx-3-(xxxx-2-xx-1-xx)xxxxxxxxxxxx-1-xx]xxxxxx}-2,2-xxxxxxxx-3- (2-methylprop-1-en-1-yl)cyklopropan- 1-karboxylát (xxxx xxxxxxxxxxxxx) (imiprothrin) |
XX |
428-790-6 |
72963-72-5 |
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x |
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790 |
5-chlor-2-(4-chlorfenoxy)fenol (XXXX) |
XX |
429-290-0 |
3380-30-1 |
x |
x |
|
x |
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807 |
(X)-1-[(2-xxxxxxxxxxxx-5-xx)xxxxxx]-3-xxxxxx-2-xxxxxxxxxxxxx (xxxxxxxxxxxxx) |
DE |
433-460-1 |
210880-92-5 |
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x |
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952 |
Xxxxxxxx xxxxxxxxxx 2362, kmen XXXX-1743 |
XX |
xxxxxxxxxxxxxxx |
143447-72-7 |
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x |
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955 |
Bacillus xxxxxxxxxxxxx subsp. xxxxxxxxxxx, xxxx SA3A |
XX |
xxxxxxxxxxxxxxx |
xxxx xxxxxxxxxx |
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x |
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957 |
Xxxxxxxx xxxxxxxx |
XX |
xxxxxxxxxxxxxxx |
xxxx xxxxxxxxxx |
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x |
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928 |
5-chlor-2-methylisothiazol-3(2H)-on (Einecs 247-500-7) a 2-xxxxxxxxxxxxxxxx-3(2X)-xx (Xxxxxx 220-239-6), xxxx (3:1) (směs XXXX/XXX) |
XX |
xxxx |
55965-84-9 |
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x |
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x |
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x |
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x |
x |
x |
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939 |
xxxxxxx xxxxx (vyráběný reakcí xxxxxxxx chlorné x xxxxxxxxx sodného in xxxx) |
XX |
xxxx |
xxxx relevantní |
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x |
x |
x |
x |
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813 |
xxxxxxxxxxxxxx kyselina |
FR |
není xxxxxxxxxx |
33734-57-5 |
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x |
x |
x |
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1014 |
xxxxxxxx xxxxxx |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
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x |
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x |
x |
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x |
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x |
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849 |
3-xxxxxxxxxxxx-(1X,3XX)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxxxxxx) |
XX |
není xxxxxxxxxx |
188023-86-1 |
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x |
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931 |
xxxxxxxxxxxxxxxxxxxxxxx, X-X12-14(xx xxxxx číslem), xxxxxxxx reakce s xxxxxxxxxxxx kyselinou (Xxxxxxxx 20) |
XX |
xxxx xxxxxxxxxx |
139734-65-9 |
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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 oxidu xxxxxxxxxxxx x xxxxxxxx xxxxxxxxxx |
SE |
xxxx x xxxxxxxxx |
xxxx x xxxxxxxxx |
x |
x |
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x |
x |
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x |
x |
x |
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777 |
xxxxxxx xxxxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-xxxxx-5-xxxxxxxxxxxxxxxx x xxxxxxx (XXXXX) |
XX |
xxxx k dispozici |
není x xxxxxxxxx |
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x |
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810 |
fosforečnanové xxxx x xxxxxxx xxxxxxx |
XX |
xxxx k dispozici |
308069-39-8 |
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x |
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x |
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x |
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824 |
stříbrno-zinečnatý xxxxxx |
SE |
xxxx x xxxxxxxxx |
130328-20-0 |
|
x |
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x |
x |
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x |
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x |
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1013 |
xxxxxxxx-xxxxxxx zeolit |
XX |
xxxx x xxxxxxxxx |
130328-19-7 |
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x |
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x |
x |
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x |
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x |
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1017 |
xxxxxxx xxxxxxxxxxx xx xxxxx xxxxxxxxxx (jako xxxxxxxxxxxx xx xxxxx xxxxxxxxxx agregátu x xxxxxxxxxx xxxxxxxxx xx xxxxxxxxxx) |
SE |
není x xxxxxxxxx |
xxxx x xxxxxxxxx |
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x |
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1019 |
xxxx křemičitý (jako xxxxxxxxxxxx xxxxxxx xxxxxxxx x xxxxxxxxxx) |
XX |
xxxx k dispozici |
68909-20-6 |
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x |
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831 |
xxxxxxxxx |
XX |
přípravek xx xxxxxxx xxxxxxx |
61790-53-2 |
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x |
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854 |
(XX)-3-xxxx-2-xxxxx-4-xxxxxxxxxxxx-2-xxxx-(1X,3X;1X,3X)-2,2-xxxxxxx-3-(2-xxxxxxxxx-1-xxxx)-xxxxxxxxxxxxxxxxxxxxx (xxxx 4 xxxxxxx 1X xxxxx, 1X: 1X xxxxx, 1S: 1X xxx, 1R: 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 (xxxx 2 xxxxxxxxxxxxx) (esbiothrin) |
XX |
přípravek xx xxxxxxx xxxxxxx |
260359-57-7 |
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x |
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848 |
N-[(6-chlor-3-pyridyl)methyl]-N′-kyan-N-methylethanimidamid (xxxxxxxxxxx) |
XX |
xxxxxxxxx xx ochranu xxxxxxx |
160430-64-8 |
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x |
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835 |
esfenvalerát/(S)-(3-fenoxyfenyl)kyanmethyl-(S)-2-(4-chlorfenyl)-3-methylbutanoát (xxxxxxxxxxxx) |
XX |
xxxxxxxxx na xxxxxxx xxxxxxx |
66230-04-4 |
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x |
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836 |
[(3-xxxxxxxxxxxx)xxxxxxxxxx]-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxx-1-xxxxxxxxxx (α-cypermethrin) |
XX |
xxxxxxxxx xx xxxxxxx rostlin |
67375-30-8 |
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x |
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843 |
4-brom-2-(4-chlorfenyl)-1-(ethoxymethyl)-5-(trifluormethyl)pyrrol-3-karbonitril (xxxxxxxxxxxx) |
PT |
xxxxxxxxx xx xxxxxxx xxxxxxx |
122453-73-0 |
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x |
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859 |
polymer X-xxxxxxxxxxxxxxxxx(XXXXXX 204-697-4) x (xxxxxxxxxxx)xxxxxxxx (XXXXXX 203-439-8)/xxxxxxxxx xxxxxxxxx xxxxxxx xxxxxx (XX Xxxxxxx) |
HU |
xxxxxxx |
25988-97-0 |
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x |
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x |
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863 |
poly(biguanid-1,5-diylhexan-1,6-diyl) (XXXX) |
XX |
xxxxxxx |
27083-27-8/32289-58-0 |
x |
x |
x |
x |
x |
x |
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x |
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x |
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|
868 |
poly(biguanid-1,5-diylhexan-1,6-diyl-hydrochlorid) |
FR |
xxxxxxx |
91403-50-8 |
x |
x |
x |
x |
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x |
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x |
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869 |
α-[2-(xxxxxxxxxxxxxxxxxxx)xxxxx]-ω-[xxxxxxxxxxx(xxxxxxxxxx)-xxxxxxxxx] (Xxxxxx 26) |
XX |
xxxxxxx |
94667-33-1 |
|
x |
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x |
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x |
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x |
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872 |
N-didecyl-N-dipolyethoxyammonium-borát/ α, α ′-(xxxxxxxxxxxxx)xxx[ω-xxxxxxxxx(xxxxxxxxxx)]-xxx xx (xxxxxxxxxxx xxxxxx) |
EL |
xxxxxxx |
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
Tato část xxxx přílohy xxxxxxxx
— |
kombinace xxxxx x xxxx přípravku xxxxxxx x xxxxxxx xxxx, xxxxxx xxxxxxxxxx xxxxxxxxx, |
— |
xxxxxxxx xxxxxxxxx xxxxx kombinací xxxxx a typu přípravku xxxxxxxxx x xxxxxxx x xxxxx 1, xxxxx těch, xxxxx xxxx xxxxxxx x xxxxxxx, x |
— |
xxxxxxxx nanoformy xxxxx xxxxxxxxx xxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxxxx xx 4. xxxxx 2014, x xxxxxxxx těch, xxxxx xxxx xxxxxxxx schváleny. |
Kombinace xxxxx x xxxx přípravku x xxxxxxxxxxxxx xxxxxxxx xx xxxx části xxxxx xxxxxxxxx xxxxxxxxxx x neschválení podle xxxxxx 20, jestliže xxxxx xxxxx xxxxxx xxxxxxxx xx xxxxxxxx xxxxxx xx vstupu xxxxxx xxxxxxxx v platnost podle xx. 14 odst. 3 nebo xxxxx xx takové xxxxxxxx zamítnuto xxxxx xx. 17 xxxx. 4 xxxx 5.
Xxxxx xxxxxxx |
Název xxxxx |
Xxxxxxx xxxx xxxxxxxxx |
Xxxxx ES |
Číslo XXX |
1 |
2 |
3 |
4 |
5 |
6 |
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9 |
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11 |
12 |
13 |
17 |
18 |
19 |
21 |
22 |
1021 |
1,3-xxxxxxx-5,5-xxxxxxxxxxxxxxxxx (xxxx 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 |
xxxxxx(xxxxxxxx)xxxxxxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 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 |
benzyl(dimethyl)tetradecylamonium-chlorid (xxx xxxxxxx 948) |
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205-352-0 |
139-08-2 |
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227 |
2-(xxxxxxx-4-xx)xxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
205-725-8 |
148-79-8 |
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x |
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331 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxx (xxx xxxxxxx 949) |
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219-234-1 |
2390-68-3 |
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384 |
xxxxxxxx(xxxxxxx)xxxxxxx-xxxxxxx (xxx xxxxxxx 949) |
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226-901-0 |
5538-94-3 |
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399 |
xxxxxx(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxx (viz položka 948) |
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230-698-4 |
7281-04-1 |
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401 |
xxxxxxx |
XX |
231-131-3 |
7440-22-4 |
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x |
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418 |
xxxx křemičitý xxxxxxx |
XX |
231-545-4 |
7631-86-9 |
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x |
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449 |
xxxxx xxxxxxx |
XX |
231-847-6 |
7758-98-7 |
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x |
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1016 |
xxxxxxx stříbrný |
SE |
232-033-3 |
7783-90-6 |
x |
x |
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x |
x |
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x |
x |
x |
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554 |
4-[(dijodmethyl)sulfonyl]-1-methylbenzen |
XX |
243-468-3 |
20018-09-1 |
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x |
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587 |
xxxxx(xxxxxxxx)xxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 949) |
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251-035-5 |
32426-11-2 |
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601 |
xxxxxxxxxxxxxx(xxxxxxx-9-xx-1-xx)xxxxxxx-xxxxxxx (viz xxxxxxx 948) |
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253-363-4 |
37139-99-4 |
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615 |
3-fenoxybenzyl(1RS,3RS;1RS,3SR)-3-(2,2-dichlorvinyl)-2,2-dimethylcyklopropankarboxylát (xxxxxxxxxx) |
XX |
258-067-9 |
52645-53-1 |
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x |
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637 |
xxxxx(xxxxxx)xxxxxxxxxxxxxxx-xxxxxxxx (xxxxx xxxxxxx xx xxxxxxxx xxxxxxx xxxxxxxxxx xxxxx) (xxx položka 948) |
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263-080-8 |
61789-71-7 |
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638 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxxx odvozen xx xxxxxxxx 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 xxxxxxxxxxxxxxx xxxxxxxx xxxxxxx xxxx) (xxx položka 949) |
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263-090-2 |
61789-80-8 |
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647 |
alkyl(C8-C18)benzyl(dimethyl)amonium-chloridy (xxx xxxxxxx 948) |
|
264-151-6 |
63449-41-2 |
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668 |
xxxxxxx(X6-X12)xxxxxxxxxxxxxxx-xxxxxxxx (xxx položka 949) |
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269-925-7 |
68391-06-0 |
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670 |
alkyl(C8-C16)benzyl(dimethyl)amonium-chloridy (xxx položka 948) |
|
270-324-7 |
68424-84-0 |
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689 |
xxxxx(X10-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxx položka 948) |
|
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 |
xxxxxxx(X8-X18)xxxxxxxxxxxxxx-xxxxxxxx (xxx xxxxxxx 949) |
|
277-453-8 |
73398-64-8 |
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1000 |
dihydrogen-bis(monoperoxyftalato)magnesát xxxxxxxxxx |
XX |
279-013-0 |
14915-85-4 |
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x |
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998 |
xxxxxxx xxxxxxx xxxx xxx z xxxxx xxxxxxxx Xxxxxxxxxxx indica xxxxxxxxxxx xxxxx x xxxx xxxxxxxxxx organickými xxxxxxxxxxxx |
XX |
283-644-7 |
84696-25-3 |
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x |
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741 |
xxxxx(X8-X18)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxx (xxx položka 948) |
|
293-522-5 |
91080-29-4 |
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1020 |
1,3-xxxxxxx-5-xxxxx-5-xxxxxxxxxxxxxxxxxx-2,4-xxxx (xxxx xxxxxxxxxx xxxxx položky 777) |
XX |
401-570-7 |
89415-87-2 |
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x |
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778 |
1-(4-chlorfenyl)-4,4-dimethyl-3-[(1H-1,2,4-triazol-1-yl)methyl]pentan-3-ol (xxxxxxxxxxx) |
XX |
403-640-2 |
107534-96-3 |
|
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x |
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805 |
xxxxxxx xxxxxxx dimethyl-adipátu, xxxxxxxx-xxxxxxxxx x xxxxxxxx-xxxxxxxxx x peroxidem xxxxxx (xxxxxxxx) |
XX |
432-790-1 |
xxxx relevantní |
|
x |
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923 |
xxxxx(xxxxxx)xxxxxxxxxxxxxxx-xxxxxxx/xxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
|
xxxx |
8001-54-5 |
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949 |
(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx xxxx -xxxxxx-xxxxxxx) (alkyly (X6-X18) nasycené x xxxxxxxxxx, xxxxxxxx od xxxxxxxx xxxxxxx loje, xxxxxxxxxx oleje x xxxxxxxx oleje) (DDAC) |
XX |
směs xxxxx uvedených x xxxxxxx XXXXXX |
xxxx relevantní |
x |
x |
x |
x |
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x |
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x |
x |
x |
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950 |
xxxxxxxxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx nebo -methyl-sulfáty) (xxxxxx (X8-X18) nasycené x xxxxxxxxxx, odvozené xx mastných kyselin xxxx, xxxxxxxxxx oleje x sójového xxxxx) (XXXX) |
XX |
xxxx látek xxxxxxxxx x xxxxxxx XXXXXX |
není xxxxxxxxxx |
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x |
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948 |
xxxxxx(xxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx xxxx -xxxxxxxxx) (alkyly (X8-X22) xxxxxxxx x xxxxxxxxxx, xxxxxxxx od xxxxxxxx xxxxxxx loje, xxxxxxxxxx xxxxx a sójového oleje) (XXX) |
XX |
xxxx xxxxx xxxxxxxxx x seznamu XXXXXX |
není xxxxxxxxxx |
x |
x |
x |
x |
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x |
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x |
x |
x |
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849 |
3-xxxxxxxxxxxx-(1X,3XX)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxxxxxx) |
XX |
xxxx relevantní |
188023-86-1 |
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x |
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1001 |
alkyl(C12-C16)benzyl(dimethyl)amonium-chloridy (xxxx xxx látka xxxxxxxxx pod xxxxxxx 671) |
XX |
xxxx relevantní |
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 xxxxxxxxx xxx xxxxxxx 667) |
XX |
není xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
x |
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x |
1003 |
alkyl(C12-C18)(ethylbenzyl)dimethylamonium- xxxxxxxx (xxxx xxx látka xxxxxxxxx pod xxxxxxx 725) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
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 látka xxxxxxxxx xxx xxxxxxx 724) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
x |
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x |
1006 |
xxxxxxxxxxxxxx xxxx obsahující xxxxxxx, xxxxx, hliník x xxx |
XX |
xxxx xxxxxxxxxx |
398477-47-9 |
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x |
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x |
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x |
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1009 |
dialkyl(C8-C10)dimetylamonium-chloridy (xxxx xxx látka xxxxxxxxx xxx xxxxxxx 673) |
XX |
není xxxxxxxxxx |
xxxx relevantní |
x |
x |
x |
x |
x |
x |
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x |
x |
x |
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1011 |
alkyl(trimethyl)amonium-chloridy (alkyl xxxxxxx xx xxxxxxxx xxxxxxx xxxxxxxxxx xxxxx) (xxxx xxx xxxxx xxxxxxxxx pod xxxxxxx 635) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
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x |
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1012 |
xxxxxxxxxxxxxxxxx xxxxx, xxxxxxxx x xxxxxxxxx xxxxxxx/xxxxxxxx-xxxxxxxxx xxxxxx |
XX |
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 (imazalil technický) |
XX |
přípravek xx xxxxxxx xxxxxxx |
73790-28-0 |
|
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x |
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|
XXXXXXX XXX
Xxxxx
Xxxx přípravků |
Xxxxx pro xxxxxxxxxx hodnotící xxxxxx xxxxx xx. 6 odst. 3 xxxx. x) |
Xxxxx pro xxxxxxxx xxxxxxxx xxxxxxxxxx podle xx. 7 xxxx. 2 písm. b) |
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 x 22 |
31.12.2022 |
31.9.2023 |