XXXXXXXX XXXXXX V PŘENESENÉ XXXXXXXXX (XX) č. 1062/2014
xx dne 4. xxxxx 2014,
týkající xx xxxxxxxxxx programu systematického xxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx obsažených x xxxxxxxxxx přípravcích, které xxxx xxxxxxx v xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 528/2012
(Text x významem xxx XXX)
XXXXXXXX KOMISE,
x xxxxxxx xx Xxxxxxx x xxxxxxxxx Evropské xxxx,
x ohledem xx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 528/2012 xx xxx 22. xxxxxx 2012 x xxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxx a xxxxxx xxxxxxxxx (1), x xxxxxxx xx xx. 89 xxxx. 1 xxxxx xxxxxxxxxxx xxxxxxxxx nařízení,
xxxxxxxx x xxxxx xxxxxxx:
(1) |
Xxxxxxxx Xxxxxx (XX) x. 1451/2007 (2) xxxxxxx prováděcí pravidla xxx xxxxxxx přezkumu xxxxxxxxxxx xxxxxxxxxx účinných xxxxx (xxxx jen „xxxxxxx xxxxxxxx“), xxxxx xxx zahájen v souladu x xx. 16 odst. 2 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx 98/8/XX (3). Xxxxxxx tato xxxxxxxx byla xxxxxxx x xxxxxxxxx xxxxxxxxx (EU) x. 528/2012, xxxx by xxx xxxxxxxxx xxxxxxxx xxx xxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxxxxx ustanovením xxxxxxxxx nařízení. |
(2) |
Je xxxxxxxx xxxxx xxxxxxxxx xxxxxx xxxxx a xxxx xxxxxxxxx, které xxxxx xxx xxxxxxxx xx xxx x xxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxxxx xxxxxx 89 xxxxxxxx (XX) x. 528/2012 s výhradou xxxxxxxxxxxxxx xxxxxxxx. Xxxx xx xxxx xxx x x xxxxxxx xxxxxxxxx xxxxxx xxxxx x xxxx přípravku, xxxxx xxxx hodnoceny x programu xxxxxxxx. |
(3) |
Pokud xxxxxxxxx xxxxxxxx xxxxxxxx xxx xxxxxxxxx x xxxxxx xxxxx článku 6 xxxxxxxx (XX) č. 1451/2007, xxx xxxxxxxxxx se xx xxx výjimka xxx xxxxxxxxx x xxxxxx xxxxxxx x xx. 2 odst. 5 xxxx. x) xxxxxxxx (EU) x. 528/2012, xxxx xx xxx xxxxxx xxxxx, xxxxx xxxxxxxx, xxxxxxxxx x xxxxxxxx xxxxxxxx xxx xxxxxxxxx typ xxxxxxxxx. X xxxxxxxx xxxxxxxxxxxxxx předpisů xx xxxx být xxxxxx xxxxxxxx xx xxx x xxxxxxxxx xxxxxxxx xx xx xxxxxxxx uvedeného xxxxxxxxx. Xxxxxx předchozího xxxxxxxxxx xx xxx vymezit, xxxxx xxxxxxxxx tohoto xxxxxxxxxx xxxxxxx. Xxxxx xx xxxx xxxxxx x xxxxxxxxx, xxx neoznámení xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx vyplynulo x xxxx definice xxxx xxxxxxxxx v nařízení (XX) x. 528/2012 xxxxxx xxxxxxxx xxxxxxx xx xxxxxxxx 98/8/XX xxxx xx řádně xxxxxxxxxx xxxxxxxxxxx Komise xxxxxxxx x xxxxxxx x xx. 3 xxxx. 3 xxxxxxxx (EU) x. 528/2012, xxxxxxxxxxx (například rozhodnutím xx xxxx C-420/10 (4)) xxxx xxxxxxxxx xxxxxx Xxxxxx xx příslušných xxxxxx xxxxxxxxx států, xxxxx xx xxxxxxxx xxxxxxx. |
(4) |
Xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxx xxxxx, xxxxx xxx není xxxxxxxx do xxxxxxxx xxxxxxxx, x xxxx xxxxx sestává xxxx xx x xx xxxxxx, avšak xxxxxxxx xx xxxxxxxxx tohoto xxxxxxxxxx přípravku x xxxxxxxx xxxxx xxxxxxxx, xxxx xx xxx x xxxxx xxxxxxxx xxxxx použití x xxxxxxxx xx xxx xxxxxxxx xx jeho xxxxxxxxxxxx, xx xxxxxxxx xxxxxxxx x xx omezenou xxxx. |
(5) |
X xxxxx xxxxxxxxxxx x xxxxxxxxxxxx xx xxx xxx xxxxxx xxxxxxxxx xxxxxxxx látek x xxxxxxxx xxxxxxxx xx xxxxx xxxxxxxxxx částech totožný x xxxxxxxx stanoveným xxx xxxxxxx xxxxxxxxxx xxxxx xxxxxx 7 xxxxxxxx (XX) x. 528/2012 xxxx xxxxx prováděcího nařízení Xxxxxx (XX) x. 88/2014 (5). |
(6) |
Xxx xxxxx, xxxxx splňují xxxxxxxx vyloučení xxxx xxxxxxxx xxx náhradu, xx měl hodnotící xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxxxxx x xxxxxxxx xxxxx xxxxx xx. 37 odst. 1 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 1272/2008 (6), xxxxx jde x xxxxxxxxx vlastnosti xxxxxxxxxx xxxxx, a zároveň by xxxx být xxxxxxxxx xxxxx xxxxxxxxx státu xxxxxxxxx návrh xxxxxxxx xx jiných xxxx xxxxx sledovaných xxxxxxxxxx. Xxxxxxxxx příslušný xxxxx xx měl xxxx xxxxxxxxxxx agenturu x xxxxxxx látek, xxxxx xx splňovaly xxxxxxxx xxx látky perzistentní, xxxxxxxxxxxxxxx či toxické, nebo xxxxx, které xx xxxxx xxx xxxxxxxxxx xx xxxxx x xxxxxxxxxxx xxxxxxxxxxxxxx narušení xxxxxxxxxx xxxxxxxx. |
(7) |
Xxx bylo zajištěno, xx program xxxxxxxx xxxx xxxxxxxx xx xxxxxxxx xxxx xxxxxxxxx x xx. 89 xxxx. 1 nařízení (XX) x. 528/2012, xxxx xx xx xxxxxxxxx xxxxxx xx kombinace xxxxxx xxxxx a typu xxxxxxxxx, x nichž xxxx xxxxxxxxx xxxxx xxxxxxxxxx xx xxxxxxx xxxxxxxxxxx x xxxxxxxx (XX) x. 1451/2007 xxxx x xxxxx nařízení. Xxxxx xxxx xx xx měly xxxxxxxx xxxxxx xxxxx xxx xxxxxxxxx xxxxxxxxx, xxxxxxx xx se měla xxxx v úvahu xxxxxxx, že xxxxxxx xx xxxxx xxx xxxxxxxxx xxxx než xxx xxxx xxxxxxxxx xxxxxx xxxx. |
(8) |
Xxxxxxx xxxxxxxx xx xxxxxxx I xxxxxxxxx 7 xxxxxxxx (XX) x. 528/2012 xxxxx xxxxxx stanoveny xxxxx xxxxxxxxx na údaje. Xx xxxxx xxxxxx x této xxxx xxxxxx xxxxxxx x xxxxxxxx xx uvedené přílohy xx kategorie 1, 2, 3, 4, 5 xxxx 6. |
(9) |
Bez xxxxxx xx xx. 90 odst. 2 xxxxxxxx (XX) x. 528/2012 xxxxxxx x xxxxxx 91 xxxxxxxxx nařízení, xx xxxxxxxx uvedená x xxxxxx 10 xxxxxxxxx xxxxxxxx xx xxxx xxx relevantní xxx xxxxxxxx povolování xxxxxxxxxx xxxxxxxxx xx xxxxx xxxxxxxxx. Je xxxxx xxxxxx určit xxxxx xxxxxxxxx xxxx kritéria xx xxxxx xxxxxxxxxxx účinných xxxxx. |
(10) |
Xxxxxxxxxxx účastník xxxxxxxx xxxxxxxx xx xxx xxx xxxxxxx xx xx xxxxxxxx xxxxxx xxxxxxxx xx stávajícímu xxxxxxxxxxx nebo jej xxxxxxxx xx xxxxxxxxxxx, xx kvůli xxxx xxxxxxx xx xxxxxxxx xxxxxxxxx x xxxxxx xxxxxxxxx xxxxxxxx x xxxxxx, xxxxxxx jinak xx xxxxxxxxxxx účastník xxxxx xxxxxxxxx xxxxx znovu. |
(11) |
Xxxxxxx xx xxxxx v programu xxxxxxxx xxxxxxxxxx, xxxx xx xxx xxxxxxxxxx xxxxxxxx xx xx xxxxxxxxx. Xxxxx x xxxx dojde, xxxx xx xxx potenciální xxxxxxxxx xxxxxxx xxxxxxx xxxxxxx, nebylo-li xxxx xxxxxxxx xxxxxxx xxx xxxxxx, xxxxx tím xxxxxxx ke zpoždění xxxxxxxx přezkumu, x xxxxxxxx-xx xxxxxxxx xxx xxxxxxxx xx svém xxxxxxxxxx. |
(12) |
Xxxxx xx xxx xxxxxxxxx účinné xxxxx xxxxx, že identita xxxxxxxxx xxxxxxxx do programu xxxxxxxx xxxxxx neodpovídá identitě xxxxxxxx xxxxxxxxx látky, x x hodnocení xxxxx xxxxxxx závěry xxxxxxx xxxxxxxx xxxxxxxxx zařazené xxxxx, mělo by xxx xxxxx xxxx xxxxx x xxxxxxx hodnocení xxxxx definovat x xxxxxxx xxxxx osobám, xxx xxxxxxxx podporu xxxx xxxxxxxxx zařazené látky. |
(13) |
Xxxxxxx xxxxx zařazené xx xxxxxxxx xxxxxxxx nejsou x xxxx přijetí xxxxxx xxxxxxxx podporovány xxxxxx xxxxxxxxxx. Xxxxx xx xxxx určitých xxxxxxxxxxxxx, xxxxxx xxxxx xx. 4 xxxx. 4 xxxxxxxx (XX) x. 528/2012 tyto xxxxxxxxx xxxxx schválit, xxxxx xxx není xxxxxxxx stanoveno. U xxxxxxxxx xxxxx a xxxxxxxxxxxxx by xxxx xxx xxxxx možnost xxxxxxx xxxxx, xxxxxxx xxxxx xx tyto xxxxx a nanomateriály xxxxxx xxx z xxxxxxxx xxxxxxxx vyloučeny. |
(14) |
Xxx bylo xxxxxxxxx, že žádná xxxxx nezůstane x xxxxxxxx xxxxxxxxxxx xxx xx xxx xxxxxx xxxxxxxx, aniž by xxxxxxxx xxxx xxxxxxxxxxx, xxxx by xxxxxxxx xxxxx, která ještě xxxxxx hodnocena, v xxxxxxxx xxxx xxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxx x xx, |
XXXXXXX XXXX NAŘÍZENÍ:
XXXXXXXX 1
XXXXXXX X XXXXXXXX
Xxxxxx 1
Xxxxxxx
Xxxx xxxxxxxx xxxxxxx xxxxxxxx xxx xxxxxxxxx xxxxxxxxxx programu xxxxxxxxxxxxxx přezkumu všech xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx v článku 89 xxxxxxxx (XX) č. 528/2012.
Xxxxxx 2
Xxxxxxxx
Xxx xxxxx xxxxxx xxxxxxxx se xxxxxxx tyto definice:
x) |
„rozhodnutím x neschválení“ xx xxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx látky x xxxx xxxxxxxxx podle 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/ES; |
x) |
„xxxxxxxxx xxxxx x xxxx přípravku xxxxxxxxx xx xxxxxxxx xxxxxxxx“ se xxxxxx kombinace látky x xxxx přípravku uvedená x xxxxxxx XX, xxxxx xxxxxxx xxxx xxxxxxxx:
|
x) |
„xxxxxxxxxx“ xx xxxxxx xxxxx, která xxxxxxxxxx xxxxxx x xxxxxxxxx látky x xxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxxx xxxxxxxxxx xxxxxxxx, které xxxxxxxx xxxxxxxxxx podle xx. 17 xxxx. 5 xxxxxx xxxxxxxx, xxxx xxxxxx xxxxxx xxxx tato xxxxxx xxxx oznámení předloženo; |
x) |
„hodnotícím xxxxxxxxxx orgánem“ xx xxxxxx xxxxxxxxx orgán xxxxxxxxx státu uvedeného x xxxxxxx XX xxxxxx xxxxxxxx, xxxxxx x xxxxxxx x xxxxxxx 81 nařízení (XX) x. 528/2012. |
XXXXXXXX 2
XXXXXX XXXXXXXXX XXXXXXXXXXX
Xxxxxx 3
Xxxxxx o xxxxxxxxx xxxx zařazení xx xxxxxxx X xxxxxxxx (XX) x. 528/2012
1.&xxxx;&xxxx;&xxxx;Xxxxxx x&xxxx;xxxxxxxxx xx xxxxxxxx do přílohy X&xxxx;xxxxxxxx (XX) x.&xxxx;528/2012 může xxxxx xxxxx xxxxxxxx, x jehož xxxxxxxx xxxxx xxxxxxxx x xxxxxx, xx xxxxxxxx xxxxxxxxxx xxxxx xx.&xxxx;17 xxxx.&xxxx;5 tohoto xxxxxxxx.
Xxxxx xx žádost 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 v odstavci 1 se podávají xxxxxxxx do dvou let xx prohlášení o souladu x xxxxxxxxx xxxxx xx.&xxxx;17 xxxx.&xxxx;5.
Xxxxxx 4
Xxxxxxx xxxxxxx
1. Xxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxx xxxxxxxx podle xxxxxxxxxxx xxxxxxxx Komise (XX) x. 564/2013 (7) x zamítne žádost, xxxxx účastník xxxxxxxxx xxxxxxxx xx xxxxx 30 xxx. X xxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x hodnotící xxxxxxxxx orgán.
2. Xx xxxxxxxx xxxxxxxx xxxxxxxxx podle xxxxxxxxxxx nařízení (EU) x. 564/2013 přijme xxxxxxxx xxxxxx x xxxxxxxxx x tom xxxxxxxxx x xxxxxxxxx xxxxxxxxx xxxxx, xxxxxxx xxxxx xxxxx xxxxxxx xxxxxxx x xxxx xxxxxxxxx xxxxxxxxxxxxx xxx.
3. Proti xxxxxxxxxxx agentury xxxxx xxxxxxxx 1 xxxxxx xxxxxx xxx xxxxx xxxxxxx xxxxxxxxxx x xxxxxxx s xxxxxxx 77 xxxxxxxx (XX) x. 528/2012.
4. Xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx x xxxxxxxx splatném xxxxx čl. 80 xxxx. 2 xxxxxxxx (XX) x. 528/2012 xx 30 dnů xxxx, xx xxxxxxxx xxxxxxx žádost, x xxxxxxx žádost, xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xx lhůtě 30 xxx. X xxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x agenturu.
Xxxxxx 5
Potvrzení xxxxxxx x xxxxxxxxx nebo xxxxxxxx do kategorie 6 xxxxxxx I xxxxxxxx (EU) č. 528/2012
1. Xxxxx xxxxxxxx přijme xxxxx xx. 4 xxxx. 2 žádost x xxxxxxxxx xxxx xxxxxxxx xx xxxxxxxxx 6 xxxxxxx X xxxxxxxx (EU) x. 528/2012, xxxxx xxxxxxxx xxxxx xxxxxxxxxx x xxxxxxx s čl. 6 xxxx. 1 x 2 xxxxxxxxx xxxxxxxx, a byl xxxxxxxx xxxxxxxx podle xx. 4 odst. 4, xxxxxxxxx xxxxxxxxx xxxxx žádost xxxxxxx xx 30 xxx xx xxxxxxxxx poplatků.
2. Pokud xxxxxxxxx příslušný orgán xxxxxxx xx xxxxxxxxx dokumentaci xxxxx xxxxxxxx (XX) x. 1451/2007, xxxxx xx xxxxx nebyla uznána xxxx xxxxx podle xxxxxx 13 uvedeného xxxxxxxx, potvrdí xxxxxxxxx xxxxxxxxx xxxxx žádost xxxxxxxxxx xx 3. xxxxx 2015.
3. X případech xxxxxxxxx x xxxxxxxxxx 1 x 2 hodnotící xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx xxxxxxx ani xxxxxxxxxxxx xxxxxxxxxxxx údajů xxxx xxxxxxxxxx.
4. Xxxxx hodnotící xxxxxxxxx orgán xxxxxx, xx xxxxxx je xxxxxxx, xxxxx xxxxxxxxxxx, xxxx xxxxxxxxxx informace xxxx x xxxxxxxxx xxxxxxx nutné, x x xxxxxxxxxx těchto xxxxxxxxx stanoví přiměřenou xxxxx. Tato xxxxx xxxxx nepřesáhne 90 dnů.
Xxxxxxxx-xx xxxxxxxxx xxxxxxxxx xxxxx, xx xxxxxxxxxx doplňující xxxxxxxxx postačují xx xxxxxxx požadavků xxxxxxxxx x odstavci 2, xxxxxxx žádost xx 30 dnů xx xxxxxxxx xxxxxxxxxxxx xxxxxxxxx.
Xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxxxxxxxx lhůtě xxxxxxxxxx, xxxxxxxxx xxxxxxxxx xxxxx xxxxxx xxxxxxx x informuje x xxxx xxxxxxxxxxx účastníka x xxxxxxxx. V xxxxxx xxxxxxxxx xx xxxxx xxxxxxxx xxxxxxxxx x xxxxxxx x xx. 80 xxxx. 1 x 2 xxxxxxxx (XX) x. 528/2012.
Xxx xxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxx, xxxxxxxx x xxxxx příslušné xxxxxx x xxxxx xxxxx xxxxxx xxxxxxxxx.
Xxxxxx 6
Xxxxxxxxx xxxxxxx
1. Tento xxxxxx se xxxxxxx, xxxxx xxxxx xxxxxxx x xxxxxx podmínek:
x) |
xx-xx xxxxxx xxxxxxxxx xxxxx xxxxxx 5; |
x) |
xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxxxx xxxx úplnou podle xxxxxx 13 xxxxxxxx (XX) x. 1451/2007, ale xxxxx xxxxxxxxxxx Komisi zprávu xxxxxxxxxxx xxxxxx xxxxx xx. 14 xxxx. 4 uvedeného xxxxxxxx; |
x) |
xxxxx xxxxxxxx xxxxxxx xxxxxx o xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4 nebo 5 xxxxxxx I nařízení (XX) č. 528/2012 xxxxx xx. 4 odst. 2 x xxx xxxxxxxx xxxxxxxx xxxxx čl. 4 xxxx. 4. |
2. Xxxxxxxxx xxxxxxxxx xxxxx zhodnotí xxxxxx xxxxx xxxxxx 4 x 5 xxxxxxxx (EU) x. 528/2012 a xxxxxxxx xxx veškeré návrhy xx xxxxxx xxxxxxxxx xx xxxxx xxxxxxxxxx x xxxxxxx x xx. 6 xxxx. 3 xxxxxxxxx xxxxxxxx x zašle hodnotící xxxxxx x xxxxxx xxxxx xxxxxxxxx agentuře.
3. Pokud xxxxxxx xxxxxxxxx xxxxx x xxxx přípravků xxxxxxxxx xxxxxxx xxxxxxxxx, xxxxxxxxx hodnotící příslušný xxxxx xxxxx jednu xxxxxxxxx zprávu. Xxxxxxxxx xxxxxx x xxxxxx xxxxx x xxxxx x xxxxxx xxxx, xxxxx toho, xx nastane později:
x) |
365 xxx po posledním xxxxxxxxx xxxxxxxx v odst. 1 xxxx. x), uznání xxxxxxxx xxxxxxxx v odst. 1 písm. b) xxxx xxxxxxxxx xxxxxxxx xxxxxxxxx x xxxx. 1 písm. c) x dotyčné kombinace xxxxx x xxxx xxxxxxxxx; |
x) |
ve xxxxx xxxxxxxxx x xxxxxxx XXX. |
4. Xxxx tím, než xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx xxx xxxxxx xxxxxxxx, umožní xxxxxxxxxxx xxxxx xx 30 xxx k xxxxxxxxx xxxxxx x x xxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx. Xxxxxxxxx příslušný xxxxx tyto xxxxxxxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxx x závěrečné fázi xxxxx xxxxxxxxx.
5. Xxxxx se xxxxx, že xxxx x hodnocení nutné xxxxxxxxxx informace, hodnotící xxxxxxxxx xxxxx účastníka xxxxx, aby xxxx xxxxxxxxx xx stanovené xxxxx xxxxxxxxx, x xxxxxxxxx o tom xxxxxxxx.
Xxxxx 365 dnů xxxxxxx x xxxxxxxx 3 xx xxxxxxx xx xxxx xxx xxx vznesení požadavku xx dne obdržení xxxxxxxxx. Xxxxx xx xxxx odůvodněno xxxxxxx xxxxxxxxxxxx xxxxx xxxx xxxxxxxxxxx xxxxxxxxxx, přerušení xxxxxxxxxx následující lhůty:
a) |
365 xxx v případě, že xx xxxxxxxxxx informace xxxxxx xxxxxx, xxxxx xxxxxx řešeny x xxxxx xxxxxxxx 98/8/ES xxxx x xxxxx xxxxxxx xxxxxxxxxxx pro xxxxxxxxxxx xxxxxxx směrnice; |
b) |
180 xxx xx xxxxx xxxxxxxxx případech. |
6. Xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxx, xx xxxxxxxx xxxxx ohledně xxxxxx xxxx xxxx zvířat xxxx xxxxxxxxx prostředí vyplývající x xxxxxxxxxxxxx xxxxxx plynoucích x xxxxxxxxx xxxxxxxxxx přípravků xxxxxxxxxxxx xxxxxx nebo xxxxxxxx účinné xxxxx, xxx xxxxx xxxxxxxxxxxx x xxxxxxx s požadavky xxxxxxxxxxx xxxxx xxxxxx XX xxxx 3 přílohy XX xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 1907/2006 (8) x xxxxxx xx do xxxxx xxxxxx.
7. X xxxxxxx potřeby xx xxxxxxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx bez xxxxxxxxxx xxxxxxx a nejpozději při xxxxxxxxxx hodnotící xxxxxx xxxxx odstavce 3:
x) |
xxxxxxxx xxxxx xxxxxxxx podle xx. 37 xxxx. 1 nařízení (XX) x. 1272/2008, xxxxxxxx xx xxxxxxx, xx xx xxxxxxx xxxxx x xxxxxxxx xxxxxxxxx x xx. 36 xxxx. 1 xxxxxxxxx xxxxxxxx, ale xxxx xxxxxxxx řešeno x xxxxx 3 xxxxxxx XX xxxxxxxxx xxxxxxxx; |
x) |
xxxxxxxxxx x xxxxxxxxx, xxxxx se xxxxxxx, xx xxxxx x xxxxxxxx čl. 5 xxxx. 1 písm. d) xxxx x) nařízení (XX) x. 528/2012 xxxx xxxxxxxx xx. 10 xxxx. 1 xxxx. x) xxxxxxxxx xxxxxxxx xxxx xxxxxxx, ale xxxxxx xxxxxxxx xxxxxx v příloze XXX xxxxxxxx (XX) x. 1907/2006 xxxx x xxxxxxx xxxxxxxx v čl. 59 xxxx. 1 xxxxxxxxx nařízení. |
Xxxxxx 7
Xxxxxxxxxx xxxxxxxx
1. Tento xxxxxx xx xxxxxxx, xxxxx xxxxx xxxxxxx x xxxxxx xxxxxxxx:
a) |
pokud xxxxxxxxx xxxxxxxxx xxxxx předložil xxxxxxxxx zprávu xxxxx xx. 6 odst. 2 a xxxxxxxx předložil xxxxx xxxx xxxxxxx xxxxxxxxxx xxxxx xx. 6 xxxx. 7; |
x) |
pokud xxxx předložena Xxxxxx xxxxxx příslušného xxxxxx xxxxx xx. 14 odst. 4 xxxxxxxx (XX) č. 1451/2007, xxx xxxxxxxxx xxxxxx xxxxx nepřezkoumal Xxxxx xxxxx xxx biocidní xxxxxxxxx podle xx. 15 xxxx. 4 xxxxxxxxx nařízení. |
2. Xx xxxxxxx xxxxxx xxxxxxxx xxxxxxxxx x xxxxxxxx Xxxxxx xxxxxxxxxx x xxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxx xxxx xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx X xxxxxxxx (XX) č. 528/2012, xxxxxxxx obojím, x xxxxxxx xx xxxxxx xxxxxxxxxxx příslušného xxxxxx.
Xxxxxxxx xxxxxx přípravu xxxxxxxxxx x xxxxx x xxxxxx xxxx, xxxxx xxxx, xx xxxxxxx xxxxxxx:
a) |
xx xxx xxxxxx xx xxxxxxx xxxxxx; |
b) |
xx xxxxx xxxxxxxxx x xxxxxxx XXX. |
Agentura xxxxxxxx xxxxxxxxxx Xxxxxx xx 270 dnů od zahájení xxxxxxxx.
Xxxxxx 8
Účinné látky, xxxxx xx xxxx xxxxxxxx
1. Xxx xxxxxxxx xxxxx xxxxxxxxxx xxxxx xx. 7 xxxx. 2 agentura xxxxxxx, xxx xxxxxx xxxxx xxxxxxx xxxxxxx x xxxxxxxx xxxxxxxxx v čl. 10 xxxx. 1 xxxxxxxx (EU) č. 528/2012, x xxxx xxxxxx zmíní xx xxxx xxxxxxxxxx.
2. Aniž xxxx xxxxxxx xxxxxx 66 x 67 xxxxxxxx (XX) x. 528/2012, xxxxx xxx xxxxxxxx předloží xxx xxxxxxxxxx Xxxxxx, xxxxxxxx xxxxxxxxx o možných xxxxxxx, xxxxx se xxxx xxxxxxxx, během maximálně 60 xxx; x xxxx xxxx mohou xxxxxxxxxx xxxxx xxxxxx xxxxxxxxx příslušné xxxxxxxxx xxxxxx xxxxxxxxx o dostupných xxxxxxxxx. Xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxx x závěrečné fázi xxxxxxxx svého stanoviska.
3. Pokud xx účinná látka xxxxxxxxx x xxxxxxx xxxxx x xxxxxxxx xxxxxxxxxxx x xx. 10 xxxx. 1 xxxxxxxx (XX) x. 528/2012, xxxx xxx xxxxxxxx xx látku, xxxxx se xx xxxxxxxx, x xxxxxxxx přijatém x xxxxxxx x xx. 89 odst. 1 xxxxxx xxxxxxxxxxxx uvedeného xxxxxxxx.
Xxxxxx 9
Xxxxxxxxxx Xxxxxx
Po xxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx čl. 7 xxxx. 2 Xxxxxx bez xxxxxxxxxx xxxxxxxx xxxxxxxx xxxxx xxxxxxxxxx xxx přijetí xxxxx xx. 89 odst. 1, xxxx případně xxxxx xx. 28 odst. 1 xxxxxxxx (XX) x. 528/2012.
XXXXXXXX 3
XXXXX PRVKŮ XXXXXXXX XXXXXXXX
Xxxxxx 10
Xxxxxxxxx xxxx xxxxxxxxx xxxxxxxxx xx xxxxxxxx dohodě
1. Roli xxxxxxxxx xx xxxxx xx xxxxxxxx dohodě xxxx xxxxxxxxxx účastníkem x xxxxxxxxxxxx účastníkem xxxxxxx xxxx sdílet xx předpokladu, xx xx xxxxxxxxxxx účastník xxxxx xxxxxxxxx se xx všechny údaje xxxxxxxxxx xxxx xxxxxxx xxxxxxxxxx xxxxxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxxx pro xxxxx xxxxxx xxxxxx xxxxxxxxxxx xxxxxxxx společně xxxxxxxxxxx x&xxxx;xxxxxxxxx xxxxxxxx xxxxxxxxxxxxxxx rejstříku pro xxxxxxxx xxxxxxxxx xxxxxxxxx x článku 71 xxxxxxxx (XX) x. 528/2012 (dále jen „xxxxxxxx“) a oznámení musí xxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxx x xxxxxxxx.
3.&xxxx;&xxxx;&xxxx;Xx xxxxxxxx oznámení splňujícího xxxxxxxxx xxxxx odstavce 2 agentura aktualizuje xxxxxxxxx v rejstříku xxxxxxxx xx xxxxxxxxxx xxxxxxxxx.
4.&xxxx;&xxxx;&xxxx;Xxxxx xxxxxxx na území Xxxx, xxxxx převzala xxxx xxxxxxxxx nebo se xxxxxxxxx x xxxxxxxxxxx xxxxx xxxxxx xxxxxx, xx xxx xxxxx xxxxxx 95 xxxxxxxx (XX) x.&xxxx;528/2012 xxxxxxxxxx xx xxxxx, xxxxx xxxxxxxxxx xxxxxxxxxxx nebo xxxxxxxx x přístupu x dokumentaci.
Xxxxxx 11
Odstoupení účastníků
1. Xx xx xx to, xx xxxxxxxx odstoupil x xxxxxx xx xxxxxxx xxxxxxxxx látky x xxxx xxxxxxxxx v programu xxxxxxxx, x těchto xxxxxxxxx:
x) |
xxxxx informoval agenturu xxxx hodnotící příslušný xxxxx xxxxxxxxxxxxxxx xxxxxxxxx x xxxx xxxxxx xxxxxxxxx; |
x) |
xxxxx xxxxxxxxxxx xxxxxx xx xxxxx xxxxxxx x xx. 3 xxxx. 2; |
c) |
xxxxx xxxx xxxxxx byla zamítnuta xxxxx xx. 4 xxxx. 1, xx. 4 odst. 4 xxxx xx. 5 xxxx. 4; |
x) |
xxxxx xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx ve xxxxxxx xxxxxxxxx x xx. 6 xxxx. 5; |
x) |
xxxxx xxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxxxxx xxxxxx xxxx xxxxxxxx. |
2. Xxxxxxxxxx xx považuje xx xxxxxxxxx xxxx, xxxxx x xxxx xxxxxxx xx datu, xxx xxxxxxxxx příslušný xxxxx xxxxxxxxx žadateli zprávu xxxxxxxxxxx orgánu podle xx. 6 odst. 4 xxxxxx xxxxxxxx.
Xxxxxx 12
Xxxxxxxx xxxxxxxx xxxxxxxxxx
1. Xxxxx xx x xxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx příslušný xxxxx, xxx xxxxxx xxxxxxxx, xxxxxxxxx xx xxxxxxxxx xxxxxxxxx orgán xxx xxxxxxxxxx xxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxx xx x xxxxxxx odstoupení informována xxxxxxxx, xxxxxxxxxxx xxxxxxxxx x xxxxxxxxx xxxxxxxx xx xxxxxxxxxx xxxxxxxxx.
3. Xxxxx x xxxxxxxx xxxxxxxx včas xxxxxxxxxx xxxxxxx účastníci xxxxxxxxxxx xxxxx xxxxxxxxx xxxxx a typu přípravku x xxxxx xxxx role xxxxxxxxx pro uvedenou xxxxxxxxx xxxxx převzata, xxxxxxxxx x xxx xxxxxxxx prostřednictvím xxxxxxxxx Xxxxxx.
Xxxxxx 13
Xxxx xxxxxxxx xxxxxxxxx látek
1. Xxxxx xxxxxxxxx xxxxxxxxx xxxxxx xxxxx xxxxxxxx xxxxxxx xxxxxx xxxxxxxx xx xxxxx, xxx xxxx xxxxxxx x xxxxxxx XX, xxxxxxxxx xxxxxxxxx xxxxx po konzultaci x dotyčným xxxxxxxxxx xxxxxxx novou identitu xxxxx. Xxxxxxxxx xxxxxxxxx xxxxx x xxx xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx x xxxxxxxxx aktualizuje xxxxxxxxx xxxxxxxx se xxxxxxxx xxxxx.
Xxxxxx 14
Převzetí xxxx xxxxxxxxx
1. Xxxxxxxx xxxxxxxx xxxxxxxxx xxxxx x xxxxxxxx xxxx xxxxxxxxx xxx xxxxxxxxx látky x xxxx xxxxxxxxx, xxxxx nastane xxxxx x xxxxxx případů:
x) |
pokud xxxxxxx xxxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxx xxxxxxxxxx xxxxx článku 11 x xxxxxx role xxxxxxxxx xxx xxxxx kombinaci xxxxxx předtím xxxxxxxx; |
x) |
xx xxxxxxx xxxx definice xxxxx xxxxxx 13; x xxxxx případě xx výzva týká xxxxx té látky, xx xxxxxx xx xxxxxxxx xxxxxxxxx xxxxxxxx v příloze II, xxx xxxxxxx nová xxxxxxxx xxxxx. |
2. Do dvanácti xxxxxx xxx xxx xxxxxxxxxx xxxxx xxxxxxxx 1 xxxx xxxxxxxxx osoba xxxxxxxxx xxxxxxxx pro xxxxxxxxx xxxxx xxxxxx 17.
3. Xx xxxxxxxx xxxxxx od data xxxxxx xxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxx xxxxx xxxxxxx kombinaci xxxxx a typu xxxxxxxxx xxxxxxxxx xx xxxxx 2 xxxxxxx XX xxxxx xxxxxx 17.
Xxxxxx 15
Xxxxxxxxx xxxxx x typu přípravku xxxxxxxxx pro xxxxxxxx xx xxxxxxxx xxxxxxxx
Xxxxx xxxxxxxx přípravek, xxxxx xxxxx do oblasti xxxxxxxxxx xxxxxxxx (XX) x. 528/2012 a xx xxxxxx xx xxx, xxxxxxx xx xxxxxxxxx xxxxxx látky, jež xxxx xxxxxxxxx ani xxxxxxxx xx xxxxxxxx xxxxxxxx pro xxxxx xxx xxxxxxxxx a xxxx xxxxxxxx xx xxxxxxx X uvedeného xxxxxxxx, xxxx xxxxx xxxxxxxx xxxx xx x xx vyrábí, xx xxxxxxx látka xxxxxxxxx xxx xxxxxxxx xx xxxxxxxx xxxxxxxx pro xxxxxxxxx typ přípravku xx xxxxxxx xxxxxxxxx x xxxxxx xxxxxx:
x) |
xxxxx uvádějící xxxxxxx xx xxx xx spoléhala xx xxxxxx nebo xxxxxxx xxxxxxxxxx vydané Xxxxxx nebo xxxxxxxxxx xxxxxxx xxxxxxxxxx v souladu x xxxxxxx 26 xxxxxxxx 98/8/XX xxxx xxxxxxx 81 xxxxxxxx (EU) x. 528/2012, xxxxx xx xxxxxxx xxxxxxxxxx xxxxxxxxxxxxxx xxxxxx xxxxx xxxxxxx xxxxxx xx doporučení k xxxxxxxxxxx, xx xxxxxxx xxx xxxxx x xxxxxxxxxx směrnice 98/8/XX xxxx xxxxxxxx (XX) x. 528/2012, xxxx xx xxx příslušný xxx xxxxxxxxx xxxxxx x xxxxxxxxx, pro xxxxx xxxx účinná xxxxx xxxxxxxx, x xxxxx jsou xxxxxxx xxxxxx xx xxxxxxxxxx xxxxxxxx xxxxxxxxxxx x xxxxxxxxxx přijatém podle xx. 3 xxxx. 3 xxxxxxxx (XX) x. 528/2012 xxxx x xxxxxx, xxxxxxxxx xxxxxxxx xxxxxxxxxxxx Xxxxxx; |
x) |
xxxxx xxxxxxxxx odchylky xxx xxxxxxxxx x xxxxxx xxxxxxxxx x xxxxxx 6 nařízení (XX) č. 1451/2007; |
c) |
biocidní xxxxxxxxx xxxxx podle xxxxxxxx (XX) x. 528/2012 k xxxxxxxxx xxxx přípravku, xxx tomu xxxx xxxxx xxxxxxxx 98/8/XX, v důsledku xxxxx působnosti xxxxxx xxxx xxxxxxxxx x xxxxxxxx xxxxx xxxxxxxxx xx xxxxxxxx xxxxxxxx xxx xxxxxxx xxx xxxxxxxxx, xxx xxxxxx pro xxxx. |
Xxxxxx 16
Prohlášení o xxxxx xx xxxxxxxx
1. Xxxxxxxxxx x xxxxx xxxxxxx látku, xxxxx je xxxxxxxxx xxx xxxxxxxx do programu xxxxxxxx xxxxx článku 15, xxxxxxxxx prostřednictvím xxxxxxxxx xxxxxxxxx osoba, xxx má xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx, xxxxxxx x následujících xxxxxxxx:
x) |
Komisi xxxxxxxxxx dvanáct xxxxxx xx xxxxxxxxxx xxxxxxxxxx xxxx xxxxxx xxxxxxxxx x xx. 15 xxxx. x); |
x) |
xxxxxxxx xxxxxxxxxx 30. xxxxx 2015 x případech uvedených x xx. 15 písm. b); |
x) |
Xxxxxx xxxxxxxxxx 30. xxxxx 2015 x xxxxxxxxx xxxxxxxxx v xx. 15 xxxx. x). |
2. Xxxxxxxxxx xxxx xxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx. X xxxxxxxxx xxxxxxxxx x xx. 15 písm. x) musí prohlášení xxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx, x xxxx xxxxxxx, xx xxxx splněny xxxxxxx podmínky x xxx xxxxxxx.
3. Pokud xxxx xxxxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 písm. x) xxxx c) x Xxxxxx xxxxxxx po xxxxxxxxxx s členskými státy x závěru, že xxxxxxxx 6 xxxx xxxxxxxxxx, x xxxxxxxx, xx xxxx splněny xxxxxxxx xxx xxxxxxxx xxxxxxx x xx. 15 xxxx. x), xxxxxxx o xxx xxxxxxxx.
4. Xxxxx xxxx xxxxxxxxxx xxxxxxx v případě xxxxxxxx x xx. 15 písm. x) xxxx xxxxx Xxxxxx xxxxxxxxxxx xxxxxxxx podle xxxxxxxx 3, zveřejní agentura xxxx informaci elektronickými xxxxxxxxxx s uvedením xxxxxxxxx xxxxxxxxx xxxxx a typu xxxxxxxxx. Pro účely xxxxxx xxxxxxxx se xxxxxxxxxx xxxxx čl. 3a xxxx. 3 xxxxxxx pododstavce xxxxxxxx (XX) x. 1451/2007 xxxxxxxx xx xxxxxxxxxx xxxxx tohoto xxxxxxxx.
5. Xxxxxxxxx xxxxx, xxxxx xx xxxxx xxxxxxx kombinaci xxxxx x typu xxxxxxxxx, xxx xxxx xxxxxx xxxxx xxxxxx 17 do šesti měsíců xxx xxx xxxxxxxxxx xxxxx xxxxxxxx 4.
6. X xxxxxxxxx xxxxxxxxx x xx. 15 xxxx. x) a c) xx xxxxxxxxx xxxxx a typu xxxxxxxxx xxxxxxxx za xxxxxxxxx účastníkem x xxxx xxxxxxxxx x dalšímu xxxxxxxx, pokud xxxx xxxxxxx tyto xxxxxxxx:
x) |
příslušná xxxxxx xxxxx je xxx xxxxxxxx xx xxxxxxxx xxxxxxxx; |
x) |
xxxxxxxxxxx předložená xxxxxxxxxxx xxxxxxxxx xxxxx xxx xxxxxxxxxx účinnou xxxxx xxx xxxxxxxx všechny xxxxx, které jsou xxxxxxxx pro xxxxxxxxx xxxx xxxxxxxxx; |
x) |
účastník, který xxxxxxxxx dotyčnou xxxxxxxxxxx, xxxxx, že xx xxxxx x xxxxxxx xxxx xxxxxxxxx xxxxx x xxxx přípravku. |
Xxxxxx 17
Xxxxxx oznámení
1. Xxxxxxxx xxxxx xx. 14 xxxx. 2 x 3 xxxx xx. 16 xxxx. 5 xx xxxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxxxxx xxxx xxx xxxxxxxxxx xx xxxxxxx XXXXXX. Xxxx xxxxxxxxx xxxxx xxxxxxx x xxxxxxx X.
3. Xxxxx xxxx x xxxxxxx XX xxx dotyčnou xxxxxxx xxxxx xxxxxx xxxxxxxxx xxxxxxxxx xxxxx, xxxxxxxxx xxxxxxxxxxx xxxxxxxx x xxxxx xxx vybraného xxxxxxxxxxx xxxxxx, xxxxx xx jmenován x xxxxxxx x xxxxxxx 81 xxxxxxxx (XX) x. 528/2012, a poskytne xxxxxxx xxxxxxxxx dokládající, že příslušný xxxxx xxxxxxxx s xxx, xx xxxxxxxxxxx xxxxxxx.
4. Xx xxxxxxxx xxxxxxxx x xxx uvědomí xxxxxxxx Xxxxxx x xxxxxxxxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx (XX) x. 564/2013. Xxxxxxxx xxxxxxxxxxx xxxxxxxx xxxxxxxx xx 30 dnů xx přijetí xxxxxxx xxxxxxxxx, agentura xxxxxxxx xxxxxxx a xxxxxxx x xxx xxxxxxxxxxxx x Xxxxxx.
5. Po xxxxxxxx xxxxxxxx agentura xx 30 dnů xxxxx, xxx oznámení xxxxxxxx xxxxxxxxxx uvedeným x xxxxxxxx 2. Xxxxx xxxxxxxx těmto xxxxxxxxxx xxxxxxxxxx, poskytne agentura xxxxxxxxxxxx xxxxx x xxxxx 30 xxx, xxx své xxxxxxxx xxxxxxx xxxx xxxxxxx. Xx xxxxxxxx xxxx 30xxxxx xxxxx xxxxxxxx xx 30 dnů xxx prohlásí, xx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxx 2, xxxx xxxxxxxx xxxxxxx, a xxx xxxxxxxxxx xxxxx xxxxxxxxxxxx a Xxxxxx.
6. X xxxxxxx x článkem 77 xxxxxxxx (XX) x. 528/2012 xxxxx xxxxxxxxxxx agentury podle xxxxxxxx 4 nebo 5 xxxxx xxxxxxx xxxxxxxxxx.
7. Xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxx xxxxxxxx 5:
x) |
x xxxxxxx, xx bylo xxxxxxxx předloženo xxxxx xx. 14 odst. 2 xxxx 3, xxxxxxxx neprodleně xxxxxxxxxxx informace x xxxxxxxxx xxxxxxxx se xxxxxxxxxx xxxxxxxxx x xxxxxxxx xxxxxxxx xxxxx; |
x) |
v xxxxxxx, xx xxxxxxxx bylo xxxxxxxxxx xxxxx čl. 16 xxxx. 5, xxxxxxxx xxxxxxxxxx xxxxxxxxx Komisi, xx xxxxxxxxxx bylo vyhověno. |
Xxxxxx 18
Xxxxxxxx xx xxxxxxxx xxxxxxxx
Xxxxx xx xxxxxxxxx látky x xxxx xxxxxxxxx xxxxxxxxxx xx xxxxxxxxx x xxxxxxx s čl. 16 xxxx. 6 xxxx pokud xxxxxxxx xxxxxxxxx Xxxxxx x dodržení xxxxxxxxx x xxxxxxx x xx. 17 xxxx. 7 písm. b), xxxxxx Xxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xx xxxxxxxx přezkumu.
Xxxxxx 19
Informace x xxxxxxx, které nejsou xxxxxx podporovány v xxxxx xxxxxxxx přezkumu
Xxxxx xxxxxx ve lhůtě xxxxxxxxx x xx. 16 xxxx. 5 xxxxxxxx xxxxx xxxxxxxx xxxx xxxxx xxxx xxxxxxxx xxxxxxx ve zmíněném xxxxxx přijata x xxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xx. 17 xxxx. 4 xxxx 5, agentura x xxx xxxxxxxxx xxxxxxx státy xxxxxxxxxxxxxxx xxxxxxxxx x xxxxxxxx xxxx xxxxxxxxx elektronickou xxxxxx.
Xxxxxx 20
Xxxxxxxxxx Xxxxxx x xxxxxxx, které xxxxxx xxxxxx xxxxxxxxxxx x rámci xxxxxxxx xxxxxxxx
Xxxxxx připraví návrh xxxxxxxxxx o xxxxxxxxxxx xxxxx xx. 89 xxxx. 1 xxxxxxx pododstavce nařízení (XX) č. 528/2012 x xxxxxx xxxxxxxxx:
x) |
xxxxx agentura xxxxxxxxx Xxxxxx x xxxxxxx odstoupení xxxxxxxxx xxxxx xx. 12 xxxx. 3 tohoto xxxxxxxx; |
x) |
xxxxx xxxxx osoba xxxxxxxx xxxxxxxx xx xxxxxxx xxxxxxxxxxx x xx. 14 xxxx. 2 xxxx 3 tohoto nařízení xxxx pokud xxxx xxxxxxxx předloženo a zamítnuto xxxxx xx. 17 xxxx. 4 xxxx 5; |
x) |
pokud xxxx xxxxxxxx předloženo ve lhůtě xxxxxxxxx v čl. 14 xxxx. 2 xxxx 3 xxxxxx xxxxxxxx x xxxx dodrženy xxxxxxxxx podle xx. 17 xxxx. 5 tohoto xxxxxxxx, xxx xxxxxxxx xxxxx x xxxxxxxx xxxxxxxx pouze xxxx xxxxxxxxx identity x xxxxxxx XX xxxxxx xxxxxxxx. |
V případě xxxxxxxx x xxxxxx xxxxxxxxxxx xxxx. x) xx xxxxx xxxxxxxxxx x xxxxxxxxxxx vztahuje xx xxxxxx xxxxx, na kterou xx xxxxxxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX tohoto xxxxxxxx, xxxxx xxxxxx xxxxxxxx nebo xxxxxxxx xxxxxxxxxx x xxxxxxxxx.
XXXXXXXX 4
PŘECHODNÁ OPATŘENÍ
Článek 21
Xxxxxxxxx xxxxxxxx xxx xxxxx xxxxxxx x&xxxx;xxxxxx&xxxx;15
1.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx svého xxxxxxxxxxx xxxxxxx xxxx xxxxx xxxxxxxx xx&xxxx;xxx a používání xxxxxxxxxx přípravku, který xxxxxxx xx xxxxxxxxx xxxxxx látky uvedené x xx. 15 xxxx. x) a x), xxxx látku xxxxxxxx nebo x xx vzniká. V xxxxxx případech:
a) |
nesmí xxx xxxxxxxx přípravek nadále xxxxxxx na trh x&xxxx;xxxxxxx xx&xxxx;24 měsíců po xxxx xxxxxx tohoto xxxxxxxx x&xxxx;xxxxxxxx; |
x) |
xxxxxxxxx xxxxxx xxxxxxxxxx přípravku xxxxx xxx dále xxxxxxxxx xx&xxxx;30 měsíců xx xxx xxxxxx xxxxxx xxxxxxxx x&xxxx;xxxxxxxx. |
2.&xxxx;&xxxx;&xxxx;Xxxxxxx stát xxxx pokračovat v uplatňování xxxxx xxxxxxxxxxx systému xxxx xxxxx xxxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxxxx biocidního xxxxxxxxx, xxxxx xxxxxxx xx xxxxxxxxx xxxxxx xxxxx uvedené v xx. 15 xxxx. x), tuto látku xxxxxxxx xxxx x xx xxxxxx. X xxxxxx případech:
a) |
nesmí být xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;24 měsíců xx xx z dále xxxxxxxxx xxxxxxxx, xxxxx xxxxxxx později:
|
x) |
xxxxxxxxx xxxxxx biocidního xxxxxxxxx xxxxx xxx dále xxxxxxxxx xx&xxxx;30 měsíců xx té z xxxx xxxxxxxxx událostí, xxxxx nastane později:
|
3.&xxxx;&xxxx;&xxxx;Xxxxxxx stát xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx xxxx xxxxx dodávání na trh x&xxxx;xxxxxxxxx biocidního xxxxxxxxx, xxxxx xxxxxxx xx xxxxxxxxx xxxxxx látky xxxxxxxxxx xxxxxxxxx podle xx. 16 xxxx. 4 xxx xxxxxxxxx xxx xxxxxxx, tuto xxxxx xxxxxxxx nebo x ní xxxxxx. X xxxxxx xxxxxxxxx:
x) |
xxxxx xxx xxxxxxxx xxxxxxxxx xxxxxx dodáván xx&xxxx;xxx x&xxxx;xxxxxxx od dvanácti xxxxxx xx xxxx, xxx xxxxxxxx provedla elektronické xxxxxxxxxx xxxxx xxxxxx 19 x |
x) |
xxxxxxxxx zásoby xxxxxxxxxx přípravku xxxxx xxx xxxx xxxxxxxxx xx&xxxx;xxxxxxxx měsíců xx xxxx xxxxxxxxx xxxxxxxxxx. |
Xxxxxx 22
Xxxxxxxx použití
1. Xxxx xx dotčen xx. 55 xxxx. 1 xxxxxxxx (XX) x. 528/2012, do osmnácti xxxxxx xx xxxx xxxxxxxxxx x xxxxxxxxxxx xxxxxxxxx xxxxxx látky, xxxxx xxxxxxx xxxx xxxxxxxx xxxx stávající xxxxxxx xxxxx za xxxxxxxxx x xxxxxx xxxxxxxxx x xx. 5 xxxx. 2 xxxxxx xxxxxxxxxxx xxxx. x) xxxx x) xxxxxxxx (XX) x. 528/2012, xxxxx xxxxxxx xxxx může xxxxxxxxx Xxxxxx odůvodněnou xxxxxx x xxxxxxxx xx xx. 89 odst. 2 xxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx xxxxxxx stát xxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx. Xxxxx žádost xxxxxxxx xxxxxxx xxxxxxxxx, xxxxxxxx xxxxxxx xxxx xxxx xxxxxxx xxxxxxxxx xxxxxxxxx xxxxx.
3. Xxxxxxxx xxxxxxxx žádost xxxx případně xxxxxxxxxx xxxxx xxxxxxxxxxxxxx xxxxxxxxxx. Xxxxxxx státy nebo xxxx xxxxx xxxxx xxxxx xxxxxxxxxx xx xxxxx 60 xxx xx xxxxxxxxxx.
4. Xx xxxxxxx xxxxxxxxxx xxxxxxxxxx xxxx Komise xxxxxxx odchylku xx xx. 89 xxxx. 2 xxxxxxx xxxxxxxxxxx xxxxxxxx (EU) x. 528/2012, xxxxx xxxxxx xxxxxx xxxxxxxx xxxxxxxxx, xxx xxxxxxxxx z této xxxxx, xxxxxxxx xx xxxx x xx xxxxxxxx, xx trh xxxxxxxxxx xxxxxxxxx xxxxx x xxxxxxxx xx v daném xxxxxxxx xxxxx x xxxxxxx x xxxxxxxxxxxxxx právními xxxxxxxx x x xxxxxxxx xxxxxxxx xxxxxxxx 5 a veškerých dalších xxxxxxxx xxxxxxxxx Komisí.
5. Členský xxxx, xxxxx xx xxxxxxxx xxxxxxxx:
x) |
xxxxxxx, xx xxxxx xxxxxxxxx xxxx omezeno xx xxxxxx případy a xxxxxxx xxxx, xxx xxxx xxxxxx podmínky xxxxxxxx 1; |
x) |
xxxxxx xxxxxx opatření xx xxxxxxxx xxxxx, xxx xxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxxxx, zvířat xxxx xxxxxxxxx xxxxxxxxx; |
x) |
xxxxxxx, xxx xx xxxxxxx alternativní xxxxxx nebo aby xxxx včas xxxx xxxxxxxxx platnosti odchylky xxxxxxxxxx žádost x xxxxxxxxx xxxxxx látky x xxxxxxx xxxxxxx 7 xxxxxxxx (XX) č. 528/2012. |
XXXXXXXX 5
ZÁVĚREČNÁ XXXXXXXXXX
Xxxxxx 23
Xxxxxxx
Xxxxxxx xx nařízení (XX) x. 1451/2007.
Xxxxxx xx zrušené nařízení xx xxxxxxxx xx xxxxxx xx xxxx xxxxxxxx.
Xxxxxx 24
Vstup v xxxxxxxx
Xxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxxxxxx xxxx po vyhlášení x Úředním věstníku Xxxxxxxx unie.
Xxxx nařízení xx xxxxxxx x xxxxx xxxxxxx x xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx xxxxxxx.
V Xxxxxxx xxx 4. xxxxx 2014.
Xx Komisi
předseda
Xxxx Manuel XXXXXXX
(1) Úř. věst. L 167, 27.6.2012, s. 1.
(2)&xxxx;&xxxx;Xxxxxxxx Xxxxxx (ES) x. 1451/2007 ze xxx 4. xxxxxxxx 2007 o xxxxx xxxxx xxxxxxxxxxxx pracovního xxxxxxxx xxxxxxxxx x xx. 16 xxxx. 2 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx a Rady 98/8/XX x uvádění xxxxxxxxxx xxxxxxxxx xx xxx (Úř. xxxx. X 325, 11.12.2007, x. 3).
(3) Směrnice Xxxxxxxxxx parlamentu x Xxxx 98/8/ES xx xxx 16. xxxxx 1998 x xxxxxxx biocidních xxxxxxxxx xx trh (Xx. xxxx. L 123, 24.4.1998, x. 1).
(4)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxx xxxxx (xxxxxxx xxxxxx) xx xxx 1. xxxxxx 2012 (žádost x xxxxxxxxxx o xxxxxxxxx xxxxxx: Xxxxxxxxxxx Hamburg – Xxxxxxx) – Xöxx GmbH xxxxx Xxxxx XxxX (uvádění xxxxxxxxxx xxxxxxxxx xx xxx – xxxxxxxx 98/8/XX – xx. 2 odst. 1 xxxx. x) – xxxxx „xxxxxxxx xxxxxxxxx“ – xxxxxxxxx, xxxxx xxxxxxxxx vločkování škodlivých xxxxxxxxx, xxxx je xxxx, odpuzuje xxxx xxxxxxxxxxx), X-420/10.
(5)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Komise (XX) x.&xxxx;88/2014 ze xxx 31.&xxxx;xxxxx 2014, xxxxxx se xxxxxxx xxxxxx xxx xxxxx xxxxxxx X&xxxx;xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (EU) x.&xxxx;528/2012 x&xxxx;xxxxxxxx biocidních xxxxxxxxx xx trh x&xxxx;xxxxxx xxxxxxxxx (Úř. xxxx. X 32, 1.2.2014, x. 3).
(6)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 1272/2008 xx xxx 16. xxxxxxxx 2008 x xxxxxxxxxxx, xxxxxxxxxx a xxxxxx xxxxx x směsí, x xxxxx x xxxxxxx směrnic 67/548/EHS x 1999/45/XX x x změně nařízení (XX) x. 1907/2006 (Xx. věst. 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 x&xxxx;xxxxxxxx splatných Xxxxxxxx xxxxxxxx pro xxxxxxxx xxxxx xxxxx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (EU) x.&xxxx;528/2012 x&xxxx;xxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxx x&xxxx;xxxxxx xxxxxxxxx (Xx.&xxxx;xxxx.&xxxx;X 167, 19.6.2013, s. 17).
(8)&xxxx;&xxxx;Xxxxxxxx Evropského xxxxxxxxxx x Rady (ES) x. 1907/2006 xx xxx 18. prosince 2006 x registraci, xxxxxxxxx, xxxxxxxxxx x xxxxxxxxx xxxxxxxxxx látek, x xxxxxxx Xxxxxxxx xxxxxxxx xxx chemické xxxxx, x xxxxx xxxxxxxx 1999/45/XX x x zrušení xxxxxxxx Xxxx (EHS) x.&xxxx;793/93, xxxxxxxx Komise (XX) x. 1488/94, xxxxxxxx Xxxx 76/769/XXX a xxxxxxx Komise 91/155/EHS, 93/67/XXX, 93/105/XX a 2000/21/XX (Xx. xxxx. X 396, 30.12.2006, x. 1).
XXXXXXX I
Informace xxxxxxxxxx xxx oznámení xxxxx xxxxxx 17
Xxxxxxxx xxxxx xxxxxx 17 xxxxxxxx xxxx xxxxxxxxx:
1) |
důkaz, xx xxxxx xx xxxxxxxxx účinnou xxxxxx ve smyslu xx. 3 xxxx. 1 xxxx. x) xxxxxxxx (XX) x. 528/2012; |
2) |
xxxxx x xxxx/xxxxxx přípravku, xx xxxxx/x xx xxxxxxxx xxxxxxxx; |
3) |
xxxxxxxxx x xxxxx studiích, xxxxx xxxx xxxxxx xxx xxxxx xxxxxxx x xxxxxxxxx xx xxxxxxxx xx xxxxxxx X xxxxxxxx (XX) x. 528/2012, xxxxx i očekávané xxxxx xxxxxx xxxxxxxxx; |
4) |
xxxxxxxxx xxxxxxx x oddílech
|
5) |
pokud xxxx xxxx xxxxxxxx xxxxxxx v případě xxxxxxxx x xx. 15 písm. x), xxxxx, že látka byla xx xxxx jako xxxxxx xxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxxxx do příslušného xxxx xxxxxxxxx x xxx oznámení xxxx zveřejnění rozhodnutí xxxx xxxxxx xxxxxxxxx xx xxxxxxxx písmenu. |
XXXXXXX XX
XXXXXXXXX XXXXX X XXXX PŘÍPRAVKU XXXXXXXX XX XXXXXXXX XXXXXXXX XXX 4. XXXXX 2014
ČÁST 1
Xxxxxxxxx xxxxxx látky x xxxx přípravku xxxxxxxxxxx xx xxx 4. xxxxx 2014, x xxxxxxxx xxxxxxxxxx jiných nanomateriálů xxx xxxx, xxxxx xxxx xxxxxxxx xxxxxxx x xxxxxxxxx 1017 x 1019.
Xxxxx xxxxxxx |
Xxxxx látky |
Xxxxxxx stát xxxxxxxxx |
Xxxxx ES |
Xxxxx CAS |
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200-001-8 |
50-00-0 |
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5-{[2-(2-butoxyethoxy)ethoxy]methyl}-6- xxxxxx-1,3-xxxxxxxxxxx (xxxxxxxxxxxxxxxx/XXX) |
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200-076-7 |
51-03-6 |
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200-143-0 |
52-51-7 |
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200-431-6 |
59-50-7 |
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200-578-6 |
64-17-5 |
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200-579-1 |
64-18-6 |
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xxxxxx-2-xx |
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200-661-7 |
67-63-0 |
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200-712-3 |
69-72-7 |
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xxxxxx-1-xx |
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200-746-9 |
71-23-8 |
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200-849-9 |
75-21-8 |
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kyselina xxxxxxxxx |
XX |
201-069-1 |
77-92-9 |
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xxxxxxxxx xxxxxxxx/2-xxxxxxxxxxxxxxx kyselina |
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201-180-5 |
79-14-1 |
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kyselina xxxxxxxxxxxx |
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201-186-8 |
79-21-0 |
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X-(+)-xxxxxx kyselina |
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201-196-2 |
79-33-4 |
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2-xxxxxxxxxxx-8,9-xxxxxxxxx-1,2,6,6x,12,12x-xxxxxxxxxxxxxxxxx[3,4-x]xxxx[2,3-x]xxxxxxx-6-xx (xxxxxxx) |
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201-501-9 |
83-79-4 |
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201-782-8 |
87-90-1 |
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bifenyl-2-ol |
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201-993-5 |
90-43-7 |
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203-213-9 |
104-55-2 |
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203-377-1 |
106-24-1 |
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203-474-9 |
107-22-2 |
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203-768-7 |
110-44-1 |
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203-856-5 |
111-30-8 |
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chlorofen |
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204-385-8 |
120-32-1 |
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2-xxxxxxxxxxx-1-xx |
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122-99-6 |
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xxxxxxxxxxxxxxx-xxxxxxx/1-xxxxxxxxxxxxxxxx-1-xxx-xxxxxxx |
XX |
204-593-9 |
123-03-5 |
|
x |
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179 |
xxxx xxxxxxxx |
FR |
204-696-9 |
124-38-9 |
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x |
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180 |
(natrium-kakodylát) – xxxxxxx-xxxxxxxxxxxxxxx |
XX |
204-708-2 |
124-65-2 |
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x |
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185 |
tosylchloramid, sodná xxx (xxxxx sůl xxxxxxxxxxxxxxx – xxxxxxxxx X) – (X-xxxxx-4-xxxxxxxxxxxx-1-xxxxxxxxxx |
ES |
204-854-7 |
127-65-1 |
|
x |
x |
x |
x |
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187 |
xxxxxx-xxxxxxxxxxxxxxxxxxxxxx |
XX |
204-875-1 |
128-03-0 |
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x |
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x |
x |
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188 |
natrium-dimethyldithiokarbamát |
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 |
ES |
205-055-6 |
132-27-4 |
x |
x |
x |
x |
|
x |
x |
|
x |
x |
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x |
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198 |
N-[(trichlormethyl)sulfanyl]ftalimid (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 |
DK |
206-354-4 |
330-54-1 |
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x |
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x |
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239 |
karbamonitril |
DE |
206-992-3 |
420-04-2 |
|
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x |
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x |
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253 |
tetrahydro-3,5-dimethyl-1,3,5-thiadiazin-2-thion (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 (dichlofluanid) |
XX |
214-118-7 |
1085-98-9 |
|
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x |
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x |
|
289 |
thiokyanatan xxxxx |
FR |
214-183-1 |
1111-67-7 |
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x |
|
292 |
[(1,3-xxxxx-1,3,4,5,6,7-xxxxxxxxx-2X-xxxxxxxx-2-xx)xxxxxx]-xxxxx-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxx-xxxxxxxxxxxx) |
XX |
214-619-0 |
1166-46-7 |
|
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x |
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958 |
xxxxxxxx xxxxxxxx/xxxxxxxxxxx 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 |
XX |
215-661-2 |
1338-23-4 |
x |
x |
|
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321 |
xxxxxxxxxxx |
XX |
217-129-5 |
1746-81-2 |
|
x |
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330 |
X-(3-xxxxxxxxxxx)-X-xxxxxxxxxxxxx-1,3-xxxxxx (xxxxxx) |
PT |
219-145-8 |
2372-82-9 |
|
x |
x |
x |
|
x |
|
x |
|
|
x |
x |
x |
|
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|
336 |
X,X′-xxxxxxxx-2,2′-xxxxxxxxxxxxxxxxxxxxxx (XXXXX) |
XX |
219-768-5 |
2527-58-4 |
|
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x |
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339 |
1,2-xxxxxxxxxxxxxxx-3(2X)-xx (XXX) |
XX |
220-120-9 |
2634-33-5 |
|
x |
|
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x |
|
|
x |
|
x |
x |
x |
|
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341 |
2-xxxxxxxxxxxxxxxxxxxxxxxxxx-3(2X)-xx (MIT) |
XX |
220-239-6 |
2682-20-4 |
|
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|
x |
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x |
x |
x |
|
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|
346 |
natrium-dichlorisokyanurát 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 |
XX |
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 |
|
|
|
x |
|
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x |
x |
x |
|
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|
365 |
xxxxxxx-2-xxxxx-1-xxxx, xxxxx xxx (pyrithion xxxxx) |
SE |
223-296-5 |
3811-73-2 |
|
x |
x |
|
|
x |
x |
|
x |
x |
|
|
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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|
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|
x |
x |
|
|
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|
377 |
1,3,5-xxxx(2-xxxxxxxxxxxx)xxxxxxxxx-1,3,5-xxxxxxx (HHT) |
PL |
225-208-0 |
4719-04-4 |
|
|
|
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|
x |
|
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|
x |
x |
x |
|
|
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|
382 |
1,3,4,6-xxxxxxxx(xxxxxxxxxxxxx)xxxxxxxxxxxxxxxx[4,5-x]xxxxxxxx-2,5-xxxx (TMAD) |
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 (XXXXX) |
PL |
229-222-8 |
6440-58-0 |
|
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|
x |
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|
x |
|
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|
397 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxxx (DDAC) |
XX |
230-525-2 |
7173-51-5 |
x |
x |
x |
x |
|
x |
|
x |
|
x |
x |
x |
|
|
|
|
|
|
401 |
stříbro |
SE |
231-131-3 |
7440-22-4 |
|
x |
|
x |
x |
|
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|
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|
x |
|
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|
403 |
xxx |
FR |
231-159-6 |
7440-50-8 |
|
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|
x |
|
405 |
oxid xxxxxxxx |
XX |
231-195-2 |
7446-09-5 |
|
|
|
x |
|
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|
424 |
xxxxxx xxxxx |
NL |
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 |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
434 |
tetramethrin |
XX |
231-711-6 |
7696-12-0 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
x |
|
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|
439 |
xxxxxxx xxxxxx |
XX |
231-765-0 |
7722-84-1 |
x |
x |
x |
x |
x |
x |
|
|
|
|
x |
x |
|
|
|
|
|
|
444 |
7x-xxxxxxxxxxxx-1X,3X,5X-xxxxxxx[3,4-x]xxxxxx (XXXX) |
XX |
231-810-4 |
7747-35-5 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
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|
|
450 |
xxxxxxxx stříbrný |
SE |
231-853-9 |
7761-88-8 |
x |
|
|
|
|
|
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|
|
|
453 |
xxxxxxxxxxxxx xxxxx |
XX |
231-892-1 |
7775-27-1 |
|
|
|
x |
|
|
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|
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|
|
455 |
xxxxxxxx xxxxxxxx |
XX |
231-908-7 |
7778-54-3 |
|
x |
x |
x |
x |
|
|
|
|
|
x |
|
|
|
|
|
|
|
457 |
chlor |
IT |
231-959-5 |
7782-50-5 |
|
x |
|
|
x |
|
|
|
|
|
x |
|
|
|
|
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|
|
458 |
xxxxx xxxxxx |
UK |
231-984-1 |
7783-20-2 |
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
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|
|
473 |
xxxxxxxxxx x xxxxxxxxxxx |
XX |
232-319-8 |
8003-34-7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
501 |
xxxxxxxxxxx |
XX |
234-232-0 |
10605-21-7 |
|
|
|
|
|
|
x |
|
x |
x |
|
|
|
|
|
|
|
|
515 |
xxxxxx xxxxxx |
SE |
235-183-8 |
12124-97-9 |
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
522 |
xxxx-1-xxx-1λ5-xxxxxxx-2-xxxxxxx |
XX |
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 |
NL |
237-601-4 |
13863-41-7 |
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
531 |
(xxxxxxxxx)xxxxxxxx |
UK |
238-588-8 |
14548-60-8 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
534 |
xxx(1-xxxxxxxxxxxxxx-2(1X)-xxxxxxxx-X,X)xxxxxxx xxxxxxx (xxxxxxxxx mědi) |
SE |
238-984-0 |
14915-37-8 |
|
|
|
|
|
|
|
|
|
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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′-bis(4-chlorfenyl)-1,1′-(hexan-1,6-diyl)bis(biguanid)-bis(d-glukonát) (XXXX) |
PT |
242-354-0 |
18472-51-0 |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
554 |
4-[(xxxxxxxxxxx)xxxxxxxx]-1-xxxxxxxxxxxx |
UK |
243-468-3 |
20018-09-1 |
|
|
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|
|
559 |
[(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 (OIT) |
UK |
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) |
NL |
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 (imazalil) |
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 (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 vápenato-hořečnatý/hydratované xxxxxxxxxxx xxxxx |
XX |
254-454-1 |
39445-23-3 |
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x |
x |
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606 |
[(3-xxxxxxxxxxx)xxxxxxxxxx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (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) |
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) |
MT |
259-709-0 |
55566-30-8 |
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x |
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x |
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x |
x |
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628 |
(±)-1-{[2-(2,4-dichlorfenyl)-4-propyl- 1,3-xxxxxxxx-2-xx]xxxxxx}-1X-1,2,4-xxxxxxx (xxxxxxxxxxxx) |
XX |
262-104-4 |
60207-90-1 |
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x |
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635 |
xxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxx xxxxx (ATMAC/TMAC) |
IT |
263-038-9 |
61789-18-2 |
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x |
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648 |
4,5-xxxxxxx-2-xxxxxxxxxxxxxxx-3(2X)-xx (4,5-xxxxxxx- 2-xxxxx-2X-xxxxxxxxxx-3-xx (DCOIT)) |
X |
264-843-8 |
64359-81-5 |
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x |
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x |
x |
x |
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649 |
1-(2-chlorbenzyl)-3-[(trifluormethoxy)fenyl]močovina (xxxxxxxxxxx) |
IT |
264-980-3 |
64628-44-0 |
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x |
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656 |
bis(5-methyloxazolidin-3-yl)methan (xxxxxxxxxx/XXX) |
XX |
266-235-8 |
66204-44-2 |
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x |
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x |
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x |
x |
x |
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657 |
6-(xxxxxxxxxxxxxxxx)-1,3,5-xxxxxxx-2,4-xxxxxx (xxxxxxxxx) |
EL |
266-257-8 |
66215-27-8 |
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x |
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666 |
[(3-xxxxxx-4-xxxxxxxxxx)xxxxxxxxxx]-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxx-1-xxxxxxxxxx (cyfluthrin) |
XX |
269-855-7 |
68359-37-5 |
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x |
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667 |
xxxxx(X12-18)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXX (C12-18)) |
XX |
269-919-4 |
68391-01-5 |
x |
x |
x |
x |
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x |
x |
x |
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x |
671 |
xxxxx(X12-16)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXX/XXX (X12-X16)) |
XX |
270-325-2 |
68424-85-1 |
x |
x |
x |
x |
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x |
x |
x |
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x |
673 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxxx (XXXX) (C8-10) |
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 |
alkyl(C12-C18)benzyl(dimethyl)amoniové 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 |
natrium-N-(hydroxymethyl)glycinát |
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 |
xxxxxxx, Xxxxxxxxxxx indica, 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 (XXXXXX (X12-X14)) |
XX |
287-090-7 |
85409-23-0 |
x |
x |
x |
x |
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x |
x |
x |
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x |
731 |
xxxxxxxxx xxxxxxxxxxxx, Xxxxxxxxxxxxx xxxxxxxxxxxxxxxx, xxxxxxx |
XX |
289-699-3 |
89997-63-7 |
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x |
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744 |
xxxxxxxxx xxxxxx, Xxxxxxxxx xxxxxxx, 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 (hexaflumuron) |
XX |
401-400-1 |
86479-06-3 |
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x |
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779 |
xxxxxxx produkty xxxxxxxxx xxxxxxxx x X-xxxxx(X12-X14)xxxxxx-1,2-xxxxxxx (glukoprotamin) |
DE |
403-950-8 |
164907-72-6 |
|
x |
|
x |
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785 |
6-xxxxxxxxxxxxxxxxxxxxxxx xxxxxxxx (XXX) |
XX |
410-850-8 |
128275-31-0 |
x |
x |
x |
x |
|
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791 |
2-xxxxx-1,2-xxxxxxxxxxxx-3(2X)-xx (BBIT) |
XX |
420-590-7 |
4299-07-4 |
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x |
x |
|
x |
x |
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x |
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792 |
xxxxxxx xxxxxxxxxxxxxxxxxxx (XXXX) |
XX |
420-970-2 |
92047-76-2 |
x |
x |
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x |
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811 |
xxxxxxxxxxxxxxxxxxx xxxxxxxx-xxxxx-xxxxxxxxxxx |
SE |
422-570-3 |
265647-11-8 |
x |
x |
|
x |
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x |
|
x |
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794 |
xxx-xxxxx-2,2-(2-xxxxxxxxxxxx)xxxxxxxxx-1-xxxxxxxxxx (xxxxxxxx) |
XX |
423-210-8 |
119515-38-7 |
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x |
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797 |
1-((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-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) |
DE |
433-460-1 |
210880-92-5 |
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x |
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952 |
Xxxxxxxx sphaericus 2362, xxxx ABTS-1743 |
XX |
xxxxxxxxxxxxxxx |
143447-72-7 |
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x |
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955 |
Xxxxxxxx xxxxxxxxxxxxx xxxxx. xxxxxxxxxxx, xxxx XX3X |
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-xxxxx-2-xxxxxxxxxxxxxxxx-3(2X)-xx (Xxxxxx 247-500-7) x 2-xxxxxxxxxxxxxxxx-3(2X)-xx (Xxxxxx 220-239-6), xxxx (3:1) (směs CMIT/MIT) |
XX |
směs |
55965-84-9 |
|
x |
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x |
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x |
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x |
x |
x |
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939 |
aktivní xxxxx (xxxxxxxx xxxxxx xxxxxxxx xxxxxxx x xxxxxxxxx sodného xx xxxx) |
XX |
xxxx |
xxxx xxxxxxxxxx |
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x |
x |
x |
x |
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813 |
peroxyoktanová xxxxxxxx |
XX |
není xxxxxxxxxx |
33734-57-5 |
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x |
x |
x |
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1014 |
xxxxxxxx xxxxxx |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
|
x |
|
x |
x |
|
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) |
IE |
xxxx relevantní |
188023-86-1 |
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x |
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|
931 |
alkyltrimethylendiaminy, X-X12-14(xx xxxxx xxxxxx), xxxxxxxx xxxxxx x xxxxxxxxxxxx xxxxxxxxx (Xxxxxxxx 20) |
XX |
xxxx relevantní |
139734-65-9 |
|
x |
x |
x |
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152 |
xxxxxxxx xxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-ethyl-5-methylhydantoinu x xxxxxx a xxxxxxx (XXXXX) |
XX |
xxxx x xxxxxxxxx |
není x xxxxxxxxx |
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x |
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459 |
xxxxxxx xxxx oxidu xxxxxxxxxxxx x chloridu stříbrného |
XX |
není x xxxxxxxxx |
xxxx x xxxxxxxxx |
x |
x |
|
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|
x |
x |
|
x |
x |
x |
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777 |
xxxxxxx xxxxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-xxxxx-5-xxxxxxxxxxxxxxxx x xxxxxxx (XXXXX) |
XX |
xxxx x xxxxxxxxx |
xxxx k dispozici |
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x |
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810 |
fosforečnanové xxxx x xxxxxxx xxxxxxx |
XX |
xxxx k dispozici |
308069-39-8 |
|
x |
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x |
|
x |
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824 |
xxxxxxxx-xxxxxxxxx zeolit |
XX |
není x xxxxxxxxx |
130328-20-0 |
|
x |
|
x |
x |
|
x |
|
x |
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1013 |
xxxxxxxx-xxxxxxx xxxxxx |
XX |
xxxx x xxxxxxxxx |
130328-19-7 |
|
x |
|
x |
x |
|
x |
|
x |
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1017 |
xxxxxxx xxxxxxxxxxx na xxxxx xxxxxxxxxx (xxxx xxxxxxxxxxxx xx xxxxx xxxxxxxxxx agregátu x primárními xxxxxxxxx xx xxxxxxxxxx) |
XX |
není k dispozici |
xxxx x xxxxxxxxx |
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x |
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1019 |
xxxx křemičitý (jako xxxxxxxxxxxx tvořený xxxxxxxx x xxxxxxxxxx) |
XX |
xxxx x xxxxxxxxx |
68909-20-6 |
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x |
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831 |
xxxxxxxxx |
FR |
xxxxxxxxx xx xxxxxxx rostlin |
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 1R xxxxx, 1X: 1R xxxxx, 1X: 1X xxx, 1X: 1X xxx, 1S 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) (xxxxxxxxxx) |
DE |
xxxxxxxxx na xxxxxxx xxxxxxx |
260359-57-7 |
|
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x |
|
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|
848 |
X-[(6-xxxxx-3-xxxxxxx)xxxxxx]-X′-xxxx-X-xxxxxxxxxxxxxxxxxxx (xxxxxxxxxxx) |
XX |
přípravek xx xxxxxxx xxxxxxx |
160430-64-8 |
|
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x |
|
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|
835 |
xxxxxxxxxxxx/(X)-(3-xxxxxxxxxxx)xxxxxxxxxx-(X)-2-(4-xxxxxxxxxx)-3-xxxxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
xxxxxxxxx xx xxxxxxx xxxxxxx |
66230-04-4 |
|
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|
x |
|
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|
836 |
[(3-xxxxxxxxxxxx)xxxxxxxxxx]-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxx-1-xxxxxxxxxx (α-xxxxxxxxxxxx) |
BE |
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 ochranu 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) |
XX |
polymer |
25988-97-0 |
|
x |
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x |
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863 |
xxxx(xxxxxxxx-1,5-xxxxxxxxx-1,6-xxxx) (XXXX) |
XX |
xxxxxxx |
27083-27-8/32289-58-0 |
x |
x |
x |
x |
x |
x |
|
|
x |
|
x |
|
|
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|
868 |
poly(biguanid-1,5-diylhexan-1,6-diyl-hydrochlorid) |
XX |
xxxxxxx |
91403-50-8 |
x |
x |
x |
x |
|
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x |
|
x |
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|
869 |
α-[2-(xxxxxxxxxxxxxxxxxxx)xxxxx]-ω-[xxxxxxxxxxx(xxxxxxxxxx)-xxxxxxxxx] (Xxxxxx 26) |
XX |
xxxxxxx |
94667-33-1 |
|
x |
|
x |
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x |
|
x |
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|
872 |
X-xxxxxxx-X-xxxxxxxxxxxxxxxxxxxx-xxxxx/ α, α ′-(xxxxxxxxxxxxx)xxx[ω-xxxxxxxxx(xxxxxxxxxx)]-xxx xx (xxxxxxxxxxx xxxxxx) |
EL |
polymer |
214710-34-6 |
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x |
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ČÁST 2
Xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxxxxxx xx xxx 4. xxxxx 2014
Tato xxxx xxxx přílohy xxxxxxxx
— |
xxxxxxxxx xxxxx a typu přípravku xxxxxxx x xxxxxxx níže, xxxxxx xxxxxxxxxx xxxxxxxxx, |
— |
jakékoli xxxxxxxxx xxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx x xxxxxxx x xxxxx 1, xxxxx xxxx, xxxxx xxxx xxxxxxx x xxxxxxx, x |
— |
xxxxxxxx xxxxxxxxx všech xxxxxxxxx účinných xxxxx x xxxx přípravku xxxxxxxxxxx xx 4. xxxxx 2014, x xxxxxxxx xxxx, xxxxx xxxx xxxxxxxx schváleny. |
Xxxxxxxxx xxxxx x xxxx přípravku x xxxxxxxxxxxxx xxxxxxxx xx této části xxxxx xxxxxxxxx xxxxxxxxxx x xxxxxxxxxxx xxxxx xxxxxx 20, jestliže xxxxx xxxxx xxxxxx xxxxxxxx xx xxxxxxxx měsíců xx xxxxxx xxxxxx xxxxxxxx x xxxxxxxx podle xx. 14 xxxx. 3 xxxx xxxxx je xxxxxx xxxxxxxx zamítnuto xxxxx xx. 17 xxxx. 4 xxxx 5.
Xxxxx položky |
Xxxxx xxxxx |
Členský xxxx zpravodaj |
Xxxxx XX |
Xxxxx XXX |
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1021 |
1,3-xxxxxxx-5,5-xxxxxxxxxxxxxxxxx (xxxx xxxxxxxxxx xxxxx položky 152) |
NL |
204-258-7 |
118-52-5 |
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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 xxxxxxx 948) |
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205-351-5 |
139-07-1 |
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214 |
xxxxxx(xxxxxxxx)xxxxxxxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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205-352-0 |
139-08-2 |
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227 |
2-(xxxxxxx-4-xx)xxxxxxxxxxxx (xxxxxxxxxxxx) |
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205-725-8 |
148-79-8 |
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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 xxxxxxx 948) |
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230-698-4 |
7281-04-1 |
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401 |
xxxxxxx |
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231-131-3 |
7440-22-4 |
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418 |
xxxx křemičitý xxxxxxx |
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231-545-4 |
7631-86-9 |
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449 |
xxxxx xxxxxxx |
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231-847-6 |
7758-98-7 |
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1016 |
xxxxxxx stříbrný |
SE |
232-033-3 |
7783-90-6 |
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554 |
4-[(dijodmethyl)sulfonyl]-1-methylbenzen |
XX |
243-468-3 |
20018-09-1 |
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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 |
benzyldimethyl(oktadec-9-en-1-yl)amonium-chlorid (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) |
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258-067-9 |
52645-53-1 |
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637 |
alkyl(benzyl)dimethylamonium-chloridy (xxxxx xxxxxxx xx xxxxxxxx xxxxxxx xxxxxxxxxx xxxxx) (viz položka 948) |
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263-080-8 |
61789-71-7 |
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638 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (alkyl odvozen xx xxxxxxxx kyselin xxxxxxxxxx oleje) (viz xxxxxxx 949) |
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263-087-6 |
61789-77-3 |
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639 |
dialkyl(dimethyl)amonium-chloridy (xxxxx xxxxxxx xx xxxxxxxxxxxxxxx xxxxxxxx kyselin xxxx) (xxx xxxxxxx 949) |
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263-090-2 |
61789-80-8 |
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647 |
xxxxx(X8-X18)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxx položka 948) |
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264-151-6 |
63449-41-2 |
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668 |
dialkyl(C6-C12)dimethylamonium-chloridy (xxx xxxxxxx 949) |
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269-925-7 |
68391-06-0 |
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670 |
xxxxx(X8-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxx xxxxxxx 948) |
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270-324-7 |
68424-84-0 |
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689 |
xxxxx(X10-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxx xxxxxxx 948) |
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273-544-1 |
68989-00-4 |
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692 |
xxxxx(X10-X16)xxxxxxxxxxxxxxxxx |
XX |
274-687-2 |
70592-80-2 |
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697 |
xxxxxxx(X8-X18)xxxxxxxxxxxxxx-xxxxxxxx (xxx položka 949) |
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277-453-8 |
73398-64-8 |
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1000 |
xxxxxxxxxx-xxx(xxxxxxxxxxxxxxxxx)xxxxxxxx xxxxxxxxxx |
XX |
279-013-0 |
14915-85-4 |
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998 |
xxxxxxx margosy xxxx xxx z xxxxx xxxxxxxx Xxxxxxxxxxx indica xxxxxxxxxxx xxxxx x xxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxxxxx |
XX |
283-644-7 |
84696-25-3 |
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741 |
xxxxx(X8-X18)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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293-522-5 |
91080-29-4 |
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1020 |
1,3-xxxxxxx-5-xxxxx-5-xxxxxxxxxxxxxxxxxx-2,4-xxxx (nově xxxxxxxxxx xxxxx xxxxxxx 777) |
XX |
401-570-7 |
89415-87-2 |
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778 |
1-(4-xxxxxxxxxx)-4,4-xxxxxxxx-3-[(1X-1,2,4-xxxxxxx-1-xx)xxxxxx]xxxxxx-3-xx (xxxxxxxxxxx) |
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403-640-2 |
107534-96-3 |
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805 |
xxxxxxx xxxxxxx xxxxxxxx-xxxxxxx, xxxxxxxx-xxxxxxxxx a xxxxxxxx-xxxxxxxxx x xxxxxxxxx vodíku (xxxxxxxx) |
XX |
432-790-1 |
xxxx xxxxxxxxxx |
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923 |
xxxxx(xxxxxx)xxxxxxxxxxxxxxx-xxxxxxx/xxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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xxxx |
8001-54-5 |
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949 |
(dialkyl)dimethylamonium-chloridy, -xxxxxxx xxxx -xxxxxx-xxxxxxx) (xxxxxx (X6-X18) nasycené a xxxxxxxxxx, odvozené xx xxxxxxxx xxxxxxx xxxx, xxxxxxxxxx oleje x xxxxxxxx oleje) (DDAC) |
XX |
směs xxxxx xxxxxxxxx x xxxxxxx XXXXXX |
xxxx xxxxxxxxxx |
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950 |
alkyltrimethylamonium-chloridy, -xxxxxxx xxxx -xxxxxx-xxxxxxx) (xxxxxx (X8-X18) xxxxxxxx x nenasycené, xxxxxxxx xx xxxxxxxx xxxxxxx xxxx, kokosového oleje x xxxxxxxx xxxxx) (XXXX) |
XX |
xxxx xxxxx xxxxxxxxx x seznamu XXXXXX |
xxxx xxxxxxxxxx |
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948 |
xxxxxx(xxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -bromidy xxxx -xxxxxxxxx) (alkyly (X8-X22) xxxxxxxx x xxxxxxxxxx, xxxxxxxx xx mastných xxxxxxx xxxx, xxxxxxxxxx xxxxx x xxxxxxxx xxxxx) (XXX) |
XX |
xxxx xxxxx uvedených x xxxxxxx XXXXXX |
není xxxxxxxxxx |
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849 |
3-xxxxxxxxxxxx-(1X,3XX)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxxxxxx) |
IE |
xxxx relevantní |
188023-86-1 |
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1001 |
xxxxx(X12-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxx xxx látka xxxxxxxxx xxx položku 671) |
XX |
xxxx xxxxxxxxxx |
není xxxxxxxxxx |
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1002 |
alkyl(C12-C18)benzyl(dimethyl)amonium-chloridy(jiné xxx látka xxxxxxxxx xxx xxxxxxx 667) |
XX |
není xxxxxxxxxx |
xxxx xxxxxxxxxx |
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1003 |
alkyl(C12-C18)(ethylbenzyl)dimethylamonium- xxxxxxxx (xxxx xxx látka xxxxxxxxx xxx xxxxxxx 725) |
XX |
xxxx xxxxxxxxxx |
xxxx relevantní |
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1005 |
alkyl(C12-C14)benzyl(dimethyl)amonium-chloridy (xxxx xxx látka xxxxxxxxx xxx položku 724) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
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1006 |
xxxxxxxxxxxxxx xxxx xxxxxxxxxx xxxxxxx, xxxxx, xxxxxx x xxx |
XX |
xxxx relevantní |
398477-47-9 |
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1009 |
xxxxxxx(X8-X10)xxxxxxxxxxxxxx-xxxxxxxx (xxxx xxx látka xxxxxxxxx xxx xxxxxxx 673) |
IT |
není xxxxxxxxxx |
xxxx relevantní |
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1011 |
xxxxx(xxxxxxxxx)xxxxxxx-xxxxxxxx (alkyl xxxxxxx xx mastných xxxxxxx xxxxxxxxxx oleje) (xxxx xxx xxxxx xxxxxxxxx pod xxxxxxx 635) |
XX |
xxxx relevantní |
xxxx xxxxxxxxxx |
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1012 |
xxxxxxxxxxxxxxxxx xxxxx, xxxxxxxx a xxxxxxxxx xxxxxxx/xxxxxxxx-xxxxxxxxx zeolit |
XX |
xxxx xxxxxxxxxx |
130328-20-0 |
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598 |
(±)-1-(β-xxxxxxxx-2,4-xxxxxxxxxxxxxxxxx)xxxxxxxx (xxxxxxxx technický) |
DE |
xxxxxxxxx xx xxxxxxx xxxxxxx |
73790-28-0 |
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XXXXXXX XXX
Xxxxx
Xxxx přípravků |
Xxxxx pro xxxxxxxxxx xxxxxxxxx zprávy xxxxx xx. 6 odst. 3 xxxx. x) |
Xxxxx pro zahájení xxxxxxxx stanoviska podle xx. 7 odst. 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 x 10 |
31.12.2020 |
31.3.2021 |
11, 12, 15, 17, 20 x 22 |
31.12.2022 |
31.9.2023 |