XXXXXXXX XXXXXX X XXXXXXXXX XXXXXXXXX (EU) x. 1062/2014
xx xxx 4. xxxxx 2014,
xxxxxxxx se xxxxxxxxxx xxxxxxxx systematického xxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxx x xxxxxxxxxx xxxxxxxxxxx, které xxxx xxxxxxx v xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (EU) č. 528/2012
(Xxxx x xxxxxxxx pro XXX)
XXXXXXXX XXXXXX,
x xxxxxxx xx Xxxxxxx o fungování Xxxxxxxx xxxx,
x xxxxxxx na xxxxxxxx Evropského parlamentu x Xxxx (EU) x. 528/2012 xx xxx 22. května 2012 x dodávání xxxxxxxxxx xxxxxxxxx na xxx x xxxxxx xxxxxxxxx (1), x xxxxxxx xx xx. 89 xxxx. 1 xxxxx xxxxxxxxxxx uvedeného xxxxxxxx,
xxxxxxxx x xxxxx xxxxxxx:
(1) |
Xxxxxxxx Xxxxxx (XX) x. 1451/2007 (2) xxxxxxx xxxxxxxxx pravidla xxx xxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxxxx účinných xxxxx (dále jen „xxxxxxx přezkumu“), který xxx xxxxxxx x xxxxxxx x xx. 16 xxxx. 2 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx a Rady 98/8/XX (3). Xxxxxxx tato xxxxxxxx byla xxxxxxx x xxxxxxxxx nařízením (XX) x. 528/2012, xxxx xx xxx prováděcí pravidla xxx xxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx. |
(2) |
Je xxxxxxxx xxxxx xxxxxxxxx xxxxxx xxxxx a xxxx xxxxxxxxx, xxxxx xxxxx xxx dodávány xx xxx x xxxxxxxxx podle xxxxxxxxxxx xxxxxxxxxx xxxxxx 89 xxxxxxxx (XX) x. 528/2012 x xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx. Xxxx xx xxxx xxx x v xxxxxxx xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx, xxxxx xxxx xxxxxxxxx x xxxxxxxx přezkumu. |
(3) |
Xxxxx xxxxxxxxx xxxxxxxx odchylky xxx xxxxxxxxx x xxxxxx xxxxx xxxxxx 6 xxxxxxxx (ES) č. 1451/2007, xxx nevztahuje xx xx něj výjimka xxx xxxxxxxxx x xxxxxx xxxxxxx v čl. 2 xxxx. 5 xxxx. x) nařízení (XX) x. 528/2012, xxxx xx xxx xxxxxx xxxxx, xxxxx xxxxxxxx, xxxxxxxxx x xxxxxxxx přezkumu xxx xxxxxxxxx xxx xxxxxxxxx. X xxxxxxxx vnitrostátních xxxxxxxx xx mělo xxx xxxxxx xxxxxxxx xx xxx x xxxxxxxxx xxxxxxxx xx xx xxxxxxxx xxxxxxxxx xxxxxxxxx. Xxxxxx xxxxxxxxxxx prohlášení xx xxx xxxxxxx, xxxxx xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxx. Xxxxx xx mělo xxxxxx x xxxxxxxxx, xxx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx x xxxx přípravku xxxxxxxxx x nové xxxxxxxx xxxx xxxxxxxxx x xxxxxxxx (XX) x. 528/2012 oproti xxxxxxxx xxxxxxx xx xxxxxxxx 98/8/ES xxxx xx xxxxx odůvodněno xxxxxxxxxxx Xxxxxx xxxxxxxx x xxxxxxx x xx. 3 xxxx. 3 xxxxxxxx (XX) x. 528/2012, xxxxxxxxxxx (například xxxxxxxxxxx xx xxxx C-420/10 (4)) xxxx závaznými pokyny Xxxxxx či xxxxxxxxxxx xxxxxx xxxxxxxxx xxxxx, xxxxx xx xxxxxxxx xxxxxxx. |
(4) |
Xxxxx xxxxxxxx přípravek xxxxxxxx xxxxxxx látku, xxxxx již není xxxxxxxx do xxxxxxxx xxxxxxxx, x této xxxxx xxxxxxx nebo xx z xx xxxxxx, xxxxx xxxxxxxx xx používání xxxxxx xxxxxxxxxx xxxxxxxxx x xxxxxxxx xxxxx nezbytné, xxxx xx xxx x xxxxx xxxxxxxx xxxxx xxxxxxx x xxxxxxxx xx xxx xxxxxxxx xx xxxx xxxxxxxxxxxx, xx xxxxxxxx xxxxxxxx a po omezenou xxxx. |
(5) |
X xxxxx xxxxxxxxxxx x xxxxxxxxxxxx xx xxx xxx postup xxxxxxxxx xxxxxxxx látek x xxxxxxxx xxxxxxxx ve xxxxx xxxxxxxxxx xxxxxxx xxxxxxx x xxxxxxxx xxxxxxxxxx xxx xxxxxxx předložené xxxxx xxxxxx 7 xxxxxxxx (XX) x. 528/2012 xxxx xxxxx xxxxxxxxxxx xxxxxxxx Xxxxxx (EU) č. 88/2014 (5). |
(6) |
Pro xxxxx, xxxxx splňují xxxxxxxx xxxxxxxxx nebo xxxxxxxx xxx xxxxxxx, xx xxx hodnotící xxxxxxxxx orgán xxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxxxxx a označení xxxxx xxxxx xx. 37 xxxx. 1 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) č. 1272/2008 (6), xxxxx xxx x xxxxxxxxx vlastnosti vzbuzující xxxxx, a zároveň xx xxxx xxx xxxxxxxxx xxxxx členského xxxxx xxxxxxxxx xxxxx týkající xx xxxxxx nebo xxxxx xxxxxxxxxxx xxxxxxxxxx. Xxxxxxxxx xxxxxxxxx xxxxx xx měl xxxx xxxxxxxxxxx agenturu v xxxxxxx látek, xxxxx xx splňovaly xxxxxxxx xxx xxxxx perzistentní, xxxxxxxxxxxxxxx xx xxxxxxx, nebo xxxxx, které by xxxxx být xxxxxxxxxx xx xxxxx x xxxxxxxxxxx xxxxxxxxxxxxxx narušení endokrinní xxxxxxxx. |
(7) |
Xxx xxxx xxxxxxxxx, xx xxxxxxx přezkumu xxxx dokončen do xxxxxxxx xxxx xxxxxxxxx x xx. 89 xxxx. 1 nařízení (XX) x. 528/2012, xxxx xx se xxxxxxxxx xxxxxx xx xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx, u nichž xxxx xxxxxxxxx xxxxx xxxxxxxxxx xx xxxxxxx stanovených x xxxxxxxx (XX) x. 1451/2007 xxxx x xxxxx xxxxxxxx. Xxxxx xxxx xx xx xxxx xxxxxxxx xxxxxx xxxxx xxx xxxxxxxxx xxxxxxxxx, xxxxxxx xx xx měla xxxx v úvahu xxxxxxx, xx xxxxxxx xx xxxxx xxx xxxxxxxxx xxxx xxx xxx před uplynutím xxxxxx xxxx. |
(8) |
Xxxxxxx xxxxxxxx xx xxxxxxx X xxxxxxxxx 7 nařízení (XX) x. 528/2012 xxxxx xxxxxx stanoveny xxxxx xxxxxxxxx na xxxxx. Xx xxxxx xxxxxx x této xxxx xxxxxx xxxxxxx x xxxxxxxx xx uvedené xxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6. |
(9) |
Xxx xxxxxx xx xx. 90 xxxx. 2 xxxxxxxx (XX) x. 528/2012 xxxxxxx x xxxxxx 91 xxxxxxxxx nařízení, xx xxxxxxxx xxxxxxx x xxxxxx 10 xxxxxxxxx xxxxxxxx xx xxxx být xxxxxxxxxx xxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx přípravků xx xxxxx xxxxxxxxx. Je xxxxx xxxxxx xxxxx xxxxx xxxxxxxxx xxxx kritéria xx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx. |
(10) |
Xxxxxxxxxxx účastník xxxxxxxx xxxxxxxx xx xxx xxx xxxxxxx se xx xxxxxxxx xxxxxx xxxxxxxx xx stávajícímu xxxxxxxxxxx nebo xxx xxxxxxxx xx xxxxxxxxxxx, xx kvůli xxxx xxxxxxx xx xxxxxxxx xxxxxxxxx z důvodu xxxxxxxxx xxxxxxxx k údajům, xxxxxxx xxxxx xx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx xxxxx xxxxx. |
(11) |
Xxxxxxx xx xxxxx x xxxxxxxx xxxxxxxx dobrovolná, mělo xx být účastníkům xxxxxxxx xx xx xxxxxxxxx. Pokud x xxxx xxxxx, měli xx xxx potenciální xxxxxxxxx xxxxxxx převzít xxxxxxx, nebylo-li xxxx xxxxxxxx xxxxxxx xxx xxxxxx, xxxxx tím xxxxxxx ke zpoždění xxxxxxxx xxxxxxxx, x xxxxxxxx-xx xxxxxxxx xxx xxxxxxxx na svém xxxxxxxxxx. |
(12) |
Xxxxx se xxx xxxxxxxxx xxxxxx xxxxx xxxxx, xx xxxxxxxx xxxxxxxxx xxxxxxxx do programu xxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxx hodnocené látky, x x xxxxxxxxx xxxxx xxxxxxx závěry ohledně xxxxxxxx xxxxxxxxx zařazené xxxxx, xxxx xx xxx xxxxx xxxx xxxxx x xxxxxxx xxxxxxxxx xxxxx xxxxxxxxx a povolit xxxxx xxxxxx, aby xxxxxxxx xxxxxxx xxxx xxxxxxxxx xxxxxxxx látky. |
(13) |
Xxxxxxx xxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx nejsou x xxxx xxxxxxx xxxxxx nařízení xxxxxxxxxxx xxxxxx xxxxxxxxxx. Xxxxx xx xxxx xxxxxxxx xxxxxxxxxxxxx, xxxxxx xxxxx xx. 4 odst. 4 xxxxxxxx (XX) x. 528/2012 xxxx xxxxxxxxx nelze xxxxxxxx, xxxxx tak není xxxxxxxx xxxxxxxxx. X xxxxxxxxx xxxxx x xxxxxxxxxxxxx xx xxxx xxx osoby možnost xxxxxxx xxxxx, xxxxxxx xxxxx xx xxxx xxxxx x xxxxxxxxxxxxx xxxxxx xxx z xxxxxxxx xxxxxxxx xxxxxxxxx. |
(14) |
Xxx xxxx xxxxxxxxx, xx žádná xxxxx nezůstane v xxxxxxxx xxxxxxxxxxx ani xx něj xxxxxx xxxxxxxx, xxxx by xxxxxxxx byla vyhodnocena, xxxx by xxxxxxxx xxxxx, xxxxx xxxxx xxxxxx xxxxxxxxx, x xxxxxxxx xxxx její xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxx x xx, |
XXXXXXX XXXX XXXXXXXX:
XXXXXXXX 1
PŘEDMĚT A XXXXXXXX
Xxxxxx 1
Předmět
Toto nařízení xxxxxxx pravidla xxx xxxxxxxxx xxxxxxxxxx programu xxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxx účinných látek xxxxxxxxx v článku 89 xxxxxxxx (XX) x.&xxxx;528/2012.
Xxxxxx 2
Xxxxxxxx
Xxx xxxxx xxxxxx xxxxxxxx xx xxxxxxx xxxx xxxxxxxx:
x) |
„xxxxxxxxxxx x xxxxxxxxxxx“ xx xxxxxx rozhodnutí xxxxxxxxxx xxxxxxxxx látky x xxxx xxxxxxxxx xxxxx xx. 9 xxxx. 1 písm. b) nařízení (XX) č. 528/2012 xxxx xx. 89 xxxx. 1 xxxxxxx xxxxxxxxxxx uvedeného xxxxxxxx, xxxx xxxxxxxxx nezařadit xx xxxxxxx X xxxx IA xxxxxxxx 98/8/XX; |
b) |
„xxxxxxxxx xxxxx x xxxx xxxxxxxxx zařazenou xx xxxxxxxx xxxxxxxx“ se xxxxxx xxxxxxxxx látky x xxxx xxxxxxxxx uvedená x xxxxxxx XX, xxxxx xxxxxxx xxxx xxxxxxxx:
|
x) |
„xxxxxxxxxx“ xx xxxxxx xxxxx, která xxxxxxxxxx xxxxxx x xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx nebo xxxxxxxxxx xxxxxxxx, které xxxxxxxx xxxxxxxxxx podle čl. 17 xxxx. 5 tohoto nařízení, xxxx jejímž jménem xxxx xxxx xxxxxx xxxx oznámení xxxxxxxxxx; |
d) |
„xxxxxxxxxx xxxxxxxxxx orgánem“ xx xxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx xxxxxxxxx x příloze II xxxxxx nařízení, xxxxxx x xxxxxxx x xxxxxxx 81 xxxxxxxx (XX) x. 528/2012. |
XXXXXXXX 2
POSTUP HODNOCENÍ XXXXXXXXXXX
Xxxxxx 3
Xxxxxx x xxxxxxxxx xxxx xxxxxxxx xx xxxxxxx I xxxxxxxx (XX) x. 528/2012
1.&xxxx;&xxxx;&xxxx;Xxxxxx x&xxxx;xxxxxxxxx xx xxxxxxxx xx&xxxx;xxxxxxx I nařízení (XX) x.&xxxx;528/2012 xxxx xxxxx xxxxx účastník, x xxxxx oznámení xxxxx agentura x xxxxxx, xx xxxxxxxx xxxxxxxxxx xxxxx čl. 17 xxxx.&xxxx;5 tohoto xxxxxxxx.
Xxxxx xx xxxxxx týká xxxxxxxx xx&xxxx;xxxxxxx X&xxxx;xxxxxxxx (XX) č. 528/2012, může xx týkat xxxxx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx xxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxxxxx x&xxxx;xxxxxxxx 1 se podávají xxxxxxxx do dvou let xx xxxxxxxxxx x&xxxx;xxxxxxx x xxxxxxxxx xxxxx xx.&xxxx;17 odst. 5.
Xxxxxx 4
Xxxxxxx xxxxxxx
1. Agentura xxxxxxxxx xxxxxxxxx x xxxxxxxx splatném xxxxx xxxxxxxxxxx xxxxxxxx Komise (XX) x. 564/2013 (7) x xxxxxxx xxxxxx, xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxx 30 dnů. X xxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x hodnotící xxxxxxxxx orgán.
2. Po xxxxxxxx xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx (EU) x. 564/2013 xxxxxx xxxxxxxx xxxxxx x xxxxxxxxx x xxx xxxxxxxxx x xxxxxxxxx xxxxxxxxx xxxxx, xxxxxxx xxxxx xxxxx xxxxxxx žádosti a její xxxxxxxxx identifikační xxx.
3. Xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 1 xxxxxx xxxxxx xxx podat xxxxxxx prostředek x xxxxxxx x xxxxxxx 77 nařízení (XX) x. 528/2012.
4. Xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx účastníka x xxxxxxxx splatném xxxxx xx. 80 xxxx. 2 xxxxxxxx (XX) x. 528/2012 xx 30 dnů xxxx, xx agentura xxxxxxx xxxxxx, a xxxxxxx xxxxxx, pokud xxxxxxxx nezaplatí xxxxxxxx xx xxxxx 30 xxx. X této xxxxxxxxxxx xxxxxxxxx účastníka x xxxxxxxx.
Xxxxxx 5
Xxxxxxxxx žádostí x xxxxxxxxx nebo xxxxxxxx xx kategorie 6 přílohy X xxxxxxxx (XX) x. 528/2012
1. Xxxxx xxxxxxxx xxxxxx xxxxx xx. 4 xxxx. 2 xxxxxx x xxxxxxxxx xxxx zařazení xx xxxxxxxxx 6 xxxxxxx X xxxxxxxx (EU) x. 528/2012, xxxxx obsahuje xxxxx xxxxxxxxxx v souladu x xx. 6 xxxx. 1 a 2 xxxxxxxxx xxxxxxxx, a byl xxxxxxxx xxxxxxxx xxxxx xx. 4 odst. 4, xxxxxxxxx xxxxxxxxx xxxxx žádost xxxxxxx xx 30 xxx xx xxxxxxxxx xxxxxxxx.
2. Xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxx xx xxxxxxxxx dokumentaci xxxxx xxxxxxxx (ES) x. 1451/2007, avšak xx xxxxx xxxxxx xxxxxx xxxx xxxxx xxxxx xxxxxx 13 xxxxxxxxx xxxxxxxx, xxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxx xxxxxxxxxx xx 3. ledna 2015.
3. X xxxxxxxxx uvedených x xxxxxxxxxx 1 x 2 xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx kvality ani xxxxxxxxxxxx xxxxxxxxxxxx xxxxx xxxx xxxxxxxxxx.
4. Xxxxx hodnotící xxxxxxxxx orgán xxxxxx, xx xxxxxx je xxxxxxx, sdělí xxxxxxxxxxx, xxxx doplňující xxxxxxxxx xxxx k xxxxxxxxx xxxxxxx nutné, x x xxxxxxxxxx xxxxxx xxxxxxxxx stanoví xxxxxxxxxx xxxxx. Tato lhůta xxxxx xxxxxxxxxx 90 dnů.
Rozhodne-li xxxxxxxxx xxxxxxxxx xxxxx, xx xxxxxxxxxx doplňující xxxxxxxxx xxxxxxxxx ke xxxxxxx xxxxxxxxx xxxxxxxxx x odstavci 2, xxxxxxx xxxxxx do 30 dnů xx xxxxxxxx xxxxxxxxxxxx xxxxxxxxx.
Xxxxxxxx xxxxxxxx požadované informace xx xxxxxxxxx xxxxx xxxxxxxxxx, xxxxxxxxx příslušný xxxxx xxxxxx xxxxxxx x xxxxxxxxx x xxxx xxxxxxxxxxx xxxxxxxxx x xxxxxxxx. X xxxxxx xxxxxxxxx xx xxxxx poplatky xxxxxxxxx x xxxxxxx x xx. 80 xxxx. 1 x 2 xxxxxxxx (XX) x. 528/2012.
Xxx potvrzení žádosti xxxxxxxxx příslušný xxxxx xxxxxxxxxx informuje xxxxxxxxx, xxxxxxxx x xxxxx xxxxxxxxx xxxxxx a uvede xxxxx xxxxxx xxxxxxxxx.
Xxxxxx 6
Hodnocení xxxxxxx
1. Tento xxxxxx xx xxxxxxx, xxxxx xxxxx xxxxxxx x xxxxxx podmínek:
x) |
xx-xx xxxxxx xxxxxxxxx podle xxxxxx 5; |
x) |
xxxxx xxxxxxxxx příslušný xxxxx xxxxx xxxxxxxxxxx xxxx úplnou xxxxx xxxxxx 13 xxxxxxxx (ES) x. 1451/2007, xxx xxxxx xxxxxxxxxxx Xxxxxx xxxxxx xxxxxxxxxxx orgánu podle xx. 14 odst. 4 uvedeného xxxxxxxx; |
x) |
xxxxx xxxxxxxx přijala xxxxxx x xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4 nebo 5 xxxxxxx X xxxxxxxx (XX) č. 528/2012 xxxxx xx. 4 xxxx. 2 x xxx zaplacen poplatek xxxxx xx. 4 xxxx. 4. |
2. Xxxxxxxxx xxxxxxxxx xxxxx zhodnotí xxxxxx xxxxx xxxxxx 4 x 5 xxxxxxxx (XX) č. 528/2012 x xxxxxxxx xxx veškeré návrhy xx xxxxxx xxxxxxxxx xx xxxxx předložené x xxxxxxx x xx. 6 xxxx. 3 uvedeného nařízení x xxxxx xxxxxxxxx xxxxxx a závěry xxxxx xxxxxxxxx xxxxxxxx.
3. Xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx přípravků xxxxxxxxx xxxxxxx účastníků, xxxxxxxxx hodnotící xxxxxxxxx xxxxx pouze xxxxx xxxxxxxxx xxxxxx. Hodnotící xxxxxx x xxxxxx xxxxx x xxxxx x xxxxxx xxxx, podle xxxx, xx xxxxxxx xxxxxxx:
a) |
365 xxx xx xxxxxxxxx xxxxxxxxx uvedeném x xxxx. 1 xxxx. x), uznání xxxxxxxx xxxxxxxx x xxxx. 1 xxxx. x) xxxx xxxxxxxxx poplatku xxxxxxxxx v odst. 1 písm. c) x dotyčné kombinace xxxxx x xxxx přípravku; |
b) |
xx xxxxx stanovené v příloze XXX. |
4. Xxxx xxx, xxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx xxx xxxxxx xxxxxxxx, xxxxxx xxxxxxxxxxx xxxxx xx 30 xxx x hodnotící xxxxxx x x xxxxxxx hodnocení xxxxxxx xxxxxxxxxx. Xxxxxxxxx příslušný xxxxx xxxx připomínky xxxxxxxxxxxxx xxxxxxxx xxxxxxxx x xxxxxxxxx xxxx xxxxx hodnocení.
5. Xxxxx xx xxxxx, xx jsou x hodnocení xxxxx xxxxxxxxxx xxxxxxxxx, xxxxxxxxx xxxxxxxxx orgán xxxxxxxxx xxxxx, aby xxxx xxxxxxxxx xx xxxxxxxxx xxxxx předložil, x xxxxxxxxx x xxx xxxxxxxx.
Xxxxx 365 xxx xxxxxxx x odstavci 3 se xxxxxxx xx xxxx xxx xxx vznesení požadavku xx dne obdržení xxxxxxxxx. Xxxxx xx xxxx odůvodněno povahou xxxxxxxxxxxx xxxxx xxxx xxxxxxxxxxx xxxxxxxxxx, xxxxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxx:
x) |
365 xxx x xxxxxxx, xx xx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxxx, které xxxxxx xxxxxx x xxxxx xxxxxxxx 98/8/XX xxxx x xxxxx postupů xxxxxxxxxxx pro uplatňování xxxxxxx směrnice; |
x) |
180 xxx xx xxxxx ostatních případech. |
6. Xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxx, xx xxxxxxxx xxxxx xxxxxxx zdraví xxxx xxxx xxxxxx xxxx xxxxxxxxx xxxxxxxxx vyplývající x xxxxxxxxxxxxx xxxxxx xxxxxxxxxx x xxxxxxxxx biocidních xxxxxxxxx xxxxxxxxxxxx stejné xxxx xxxxxxxx xxxxxx xxxxx, xxx obavy xxxxxxxxxxxx x xxxxxxx s požadavky příslušných xxxxx oddílu XX xxxx 3 xxxxxxx XX xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Rady (XX) x. 1907/2006 (8) x xxxxxx xx xx xxxxx xxxxxx.
7. X xxxxxxx xxxxxxx xx dokončení xxxxxxxxx xxxxxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xxx zbytečného xxxxxxx x xxxxxxxxxx xxx xxxxxxxxxx hodnotící zprávy xxxxx xxxxxxxx 3:
x) |
xxxxxxxx xxxxx xxxxxxxx xxxxx xx. 37 xxxx. 1 xxxxxxxx (XX) x. 1272/2008, xxxxxxxx xx xxxxxxx, xx xx xxxxxxx xxxxx z kritérií xxxxxxxxx x xx. 36 xxxx. 1 xxxxxxxxx nařízení, xxx xxxx náležitě xxxxxx x xxxxx 3 přílohy VI xxxxxxxxx nařízení; |
x) |
xxxxxxxxxx x xxxxxxxxx, xxxxx xx domnívá, xx xxxxx x xxxxxxxx xx. 5 xxxx. 1 xxxx. x) xxxx x) xxxxxxxx (XX) x. 528/2012 xxxx xxxxxxxx xx. 10 xxxx. 1 písm. d) xxxxxxxxx nařízení xxxx 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 se xxxxxxx, xxxxx xxxxx xxxxxxx x xxxxxx xxxxxxxx:
a) |
xxxxx hodnotící xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxxx zprávu xxxxx xx. 6 odst. 2 a xxxxxxxx předložil xxxxx xxxx xxxxxxx xxxxxxxxxx xxxxx xx. 6 xxxx. 7; |
b) |
xxxxx xxxx xxxxxxxxxx Xxxxxx xxxxxx příslušného xxxxxx xxxxx xx. 14 odst. 4 xxxxxxxx (XX) x. 1451/2007, xxx xxxxxxxxx xxxxxx xxxxx xxxxxxxxxxxx Stálý xxxxx xxx xxxxxxxx xxxxxxxxx xxxxx xx. 15 xxxx. 4 uvedeného xxxxxxxx. |
2. Po xxxxxxx xxxxxx agentura xxxxxxxxx x xxxxxxxx Xxxxxx xxxxxxxxxx o schválení xxxxxxxxx xxxxx x xxxx přípravku xxxx jeho xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 přílohy X xxxxxxxx (XX) č. 528/2012, xxxxxxxx obojím, x xxxxxxx xx xxxxxx xxxxxxxxxxx xxxxxxxxxxx xxxxxx.
Xxxxxxxx zahájí xxxxxxxx xxxxxxxxxx x xxxxx x xxxxxx xxxx, xxxxx toho, xx nastane později:
x) |
do xxx xxxxxx po xxxxxxx xxxxxx; |
x) |
ve xxxxx xxxxxxxxx v příloze III. |
Xxxxxxxx xxxxxxxx xxxxxxxxxx Komisi xx 270 xxx xx xxxxxxxx xxxxxxxx.
Xxxxxx 8
Účinné xxxxx, xxxxx xx xxxx xxxxxxxx
1. Xxx xxxxxxxx xxxxx xxxxxxxxxx xxxxx xx. 7 xxxx. 2 xxxxxxxx xxxxxxx, xxx xxxxxx xxxxx xxxxxxx některé x xxxxxxxx xxxxxxxxx x xx. 10 xxxx. 1 xxxxxxxx (XX) č. 528/2012, x xxxx otázku zmíní xx xxxx xxxxxxxxxx.
2. Xxxx xxxx xxxxxxx xxxxxx 66 x 67 xxxxxxxx (XX) x. 528/2012, xxxxx xxx xxxxxxxx předloží své xxxxxxxxxx Xxxxxx, xxxxxxxx xxxxxxxxx x xxxxxxx xxxxxxx, xxxxx se xxxx xxxxxxxx, během xxxxxxxxx 60 xxx; v xxxx xxxx xxxxx xxxxxxxxxx třetí strany xxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxxx. Xxxxxxxx xxxxxxxx xxxxxxxxx náležitě xxxxxxxx x závěrečné xxxx xxxxxxxx xxxxx xxxxxxxxxx.
3. Xxxxx xx xxxxxx xxxxx xxxxxxxxx a splňuje jedno x xxxxxxxx xxxxxxxxxxx x xx. 10 xxxx. 1 xxxxxxxx (EU) x. 528/2012, xxxx xxx xxxxxxxx xx xxxxx, xxxxx xx xx xxxxxxxx, x xxxxxxxx xxxxxxxx x xxxxxxx x xx. 89 odst. 1 xxxxxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxx.
Xxxxxx 9
Xxxxxxxxxx Komise
Xx xxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx xx. 7 xxxx. 2 Xxxxxx xxx xxxxxxxxxx xxxxxxxx xxxxxxxx návrh xxxxxxxxxx pro xxxxxxx xxxxx xx. 89 odst. 1, xxxx xxxxxxxx xxxxx xx. 28 odst. 1 xxxxxxxx (XX) x. 528/2012.
XXXXXXXX 3
XXXXX PRVKŮ XXXXXXXX XXXXXXXX
Xxxxxx 10
Xxxxxxxxx xxxx nahrazení účastníků xx xxxxxxxx xxxxxx
1.&xxxx;&xxxx;&xxxx;Xxxx xxxxxxxxx xx xxxxx xx xxxxxxxx xxxxxx xxxx stávajícím účastníkem x xxxxxxxxxxxx xxxxxxxxxx xxxxxxx nebo xxxxxx xx předpokladu, že xx xxxxxxxxxxx účastník xxxxx odvolávat xx xx xxxxxxx xxxxx xxxxxxxxxx xxxx xxxxxxx xxxxxxxxxx xxxxxxxxxx.
2.&xxxx;&xxxx;&xxxx;Xxxxxxxx pro xxxxx xxxxxx xxxxxx xxxxxxxxxxx agentuře xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxxxx xxxxxxxx xxxxxxxxxxxxxxx rejstříku xxx xxxxxxxx xxxxxxxxx xxxxxxxxx x článku 71 xxxxxxxx (XX) x. 528/2012 (xxxx jen „xxxxxxxx“) x&xxxx;xxxxxxxx musí xxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxx x xxxxxxxx.
3.&xxxx;&xxxx;&xxxx;Xx xxxxxxxx oznámení xxxxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx 2 xxxxxxxx xxxxxxxxxxx xxxxxxxxx v rejstříku xxxxxxxx xx xxxxxxxxxx xxxxxxxxx.
4.&xxxx;&xxxx;&xxxx;Xxxxx xxxxxxx na území Xxxx, xxxxx převzala roli xxxxxxxxx xxxx xx xxxxxxxxx x xxxxxxxxxxx xxxxx xxxxxx xxxxxx, xx pro xxxxx xxxxxx 95 nařízení (XX) x.&xxxx;528/2012 xxxxxxxxxx xx xxxxx, xxxxx xxxxxxxxxx xxxxxxxxxxx xxxx xxxxxxxx x xxxxxxxx x dokumentaci.
Xxxxxx 11
Xxxxxxxxxx xxxxxxxxx
1. Xx xx xx xx, xx xxxxxxxx xxxxxxxxx x účasti na xxxxxxx xxxxxxxxx xxxxx x xxxx přípravku v programu xxxxxxxx, x těchto xxxxxxxxx:
x) |
xxxxx xxxxxxxxxx xxxxxxxx xxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxxxxxxxx xxxxxxxxx x xxxx xxxxxx xxxxxxxxx; |
x) |
xxxxx xxxxxxxxxxx xxxxxx xx lhůtě xxxxxxx x xx. 3 xxxx. 2; |
c) |
pokud jeho xxxxxx xxxx xxxxxxxxx xxxxx čl. 4 xxxx. 1, xx. 4 xxxx. 4 nebo xx. 5 odst. 4; |
x) |
xxxxx xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx xx xxxxxxx xxxxxxxxx x xx. 6 xxxx. 5; |
x) |
xxxxx xxxxx nezaplatil xxxxxxxx xxxxxxxxxxx xxxxxxxxxxx xxxxxx xxxx agentuře. |
2. Odstoupení xx xxxxxxxx xx xxxxxxxxx xxxx, xxxxx x němu xxxxxxx xx xxxx, xxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxx xxxxxxxxxxx xxxxxx xxxxx xx. 6 xxxx. 4 xxxxxx xxxxxxxx.
Xxxxxx 12
Důsledky xxxxxxxx xxxxxxxxxx
1. Xxxxx je x xxxxxxx odstoupení informován xxxxxxxxx xxxxxxxxx orgán, xxx xxxxxx xxxxxxxx, xxxxxxxxx ji xxxxxxxxx xxxxxxxxx xxxxx xxx xxxxxxxxxx odkladu prostřednictvím xxxxxxxxx.
2. Xxxxx xx x xxxxxxx odstoupení xxxxxxxxxxx xxxxxxxx, aktualizuje informace x xxxxxxxxx xxxxxxxx se xxxxxxxxxx účastníka.
3. Pokud x xxxxxxxx xxxxxxxx včas xxxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx xxxxx kombinaci xxxxx x xxxx přípravku x xxxxx xxxx role xxxxxxxxx xxx xxxxxxxx xxxxxxxxx dříve xxxxxxxx, xxxxxxxxx x tom xxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx Xxxxxx.
Xxxxxx 13
Nová xxxxxxxx xxxxxxxxx xxxxx
1. Pokud hodnocení xxxxxxxxx účinné xxxxx xxxxxxxx vyvodit xxxxxx xxxxxxxx xx xxxxx, xxx xxxx xxxxxxx x xxxxxxx XX, xxxxxxxxx xxxxxxxxx xxxxx po xxxxxxxxxx x xxxxxxxx xxxxxxxxxx xxxxxxx novou xxxxxxxx xxxxx. Xxxxxxxxx xxxxxxxxx xxxxx o tom xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx v rejstříku xxxxxxxxxxx xxxxxxxxx xxxxxxxx se xxxxxxxx xxxxx.
Xxxxxx 14
Xxxxxxxx xxxx xxxxxxxxx
1. Xxxxxxxx xxxxxxxx xxxxxxxxx xxxxx x xxxxxxxx xxxx xxxxxxxxx pro xxxxxxxxx látky a typu xxxxxxxxx, pokud xxxxxxx xxxxx x xxxxxx xxxxxxx:
x) |
xxxxx xxxxxxx xxxxxxxxx podporující xxxxx kombinaci látky x xxxx přípravku xxxx xxxxxxxxxx xxxxx xxxxxx 11 x xxxxxx xxxx xxxxxxxxx xxx danou xxxxxxxxx xxxxxx xxxxxxx xxxxxxxx; |
x) |
na základě xxxx xxxxxxxx podle xxxxxx 13; v tomto xxxxxxx xx xxxxx týká xxxxx xx xxxxx, xx xxxxxx xx xxxxxxxx xxxxxxxxx identita x xxxxxxx XX, xxx xxxxxxx xxxx xxxxxxxx látky. |
2. Do dvanácti měsíců xxx xxx xxxxxxxxxx xxxxx xxxxxxxx 1 xxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxxxxx xxx xxxxxxxxx xxxxx článku 17.
3. Xx xxxxxxxx xxxxxx od data xxxxxx tohoto xxxxxxxx x xxxxxxxx může kterákoli xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxx xx xxxxx 2 přílohy II podle xxxxxx 17.
Xxxxxx 15
Xxxxxxxxx xxxxx x xxxx přípravku xxxxxxxxx xxx xxxxxxxx xx xxxxxxxx xxxxxxxx
Pokud xxxxxxxx xxxxxxxxx, který xxxxx xx xxxxxxx xxxxxxxxxx xxxxxxxx (XX) x. 528/2012 a xx xxxxxx xx xxx, xxxxxxx xx xxxxxxxxx xxxxxx xxxxx, xxx xxxx xxxxxxxxx xxx xxxxxxxx xx programu xxxxxxxx xxx xxxxx xxx xxxxxxxxx a xxxx xxxxxxxx xx xxxxxxx X xxxxxxxxx xxxxxxxx, xxxx xxxxx xxxxxxxx xxxx xx x xx xxxxxx, xx xxxxxxx xxxxx xxxxxxxxx xxx xxxxxxxx xx xxxxxxxx přezkumu pro xxxxxxxxx xxx xxxxxxxxx xx xxxxxxx xxxxxxxxx z těchto xxxxxx:
x) |
xxxxx xxxxxxxxx xxxxxxx xx xxx xx spoléhala xx xxxxxx xxxx xxxxxxx xxxxxxxxxx vydané Xxxxxx xxxx příslušným xxxxxxx xxxxxxxxxx x xxxxxxx x xxxxxxx 26 xxxxxxxx 98/8/XX nebo xxxxxxx 81 xxxxxxxx (XX) x. 528/2012, xxxxx xx základě xxxxxxxxxx opodstatněných xxxxxx xxxxx xxxxxxx xxxxxx xx doporučení k xxxxxxxxxxx, že výrobek byl xxxxx x xxxxxxxxxx xxxxxxxx 98/8/XX nebo nařízení (XX) x. 528/2012, nebo xx xxx xxxxxxxxx xxx přípravku xxxxxx x xxxxxxxxx, xxx xxxxx xxxx xxxxxx xxxxx oznámena, x xxxxx xxxx xxxxxxx xxxxxx či xxxxxxxxxx xxxxxxxx xxxxxxxxxxx v xxxxxxxxxx xxxxxxxx podle xx. 3 xxxx. 3 xxxxxxxx (XX) x. 528/2012 xxxx x xxxxxx, xxxxxxxxx xxxxxxxx xxxxxxxxxxxx Xxxxxx; |
x) |
látka xxxxxxxxx xxxxxxxx pro xxxxxxxxx x xxxxxx stanovené x xxxxxx 6 xxxxxxxx (XX) x. 1451/2007; |
x) |
biocidní xxxxxxxxx xxxxx podle nařízení (XX) č. 528/2012 k xxxxxxxxx typu xxxxxxxxx, xxx xxxx xxxx xxxxx xxxxxxxx 98/8/XX, x xxxxxxxx xxxxx xxxxxxxxxx xxxxxx xxxx xxxxxxxxx x xxxxxxxx xxxxx xxxxxxxxx xx xxxxxxxx xxxxxxxx pro xxxxxxx xxx přípravku, xxx xxxxxx pro xxxx. |
Xxxxxx 16
Xxxxxxxxxx x xxxxx xx xxxxxxxx
1. Prohlášení x xxxxx xxxxxxx látku, xxxxx je způsobilá xxx xxxxxxxx do programu xxxxxxxx podle xxxxxx 15, xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx, xxx xx xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx, xxxxxxx x xxxxxxxxxxxxx xxxxxxxx:
x) |
Komisi xxxxxxxxxx xxxxxxx měsíců xx xxxxxxxxxx rozhodnutí xxxx xxxxxx xxxxxxxxx x xx. 15 xxxx. x); |
x) |
xxxxxxxx nejpozději 30. října 2015 x případech xxxxxxxxx x xx. 15 písm. b); |
x) |
Xxxxxx xxxxxxxxxx 30. xxxxx 2015 v xxxxxxxxx xxxxxxxxx x xx. 15 xxxx. x). |
2. Xxxxxxxxxx xxxx obsahovat xxxxxxxxxx kombinaci látky x xxxx xxxxxxxxx. V případech xxxxxxxxx x xx. 15 písm. x) musí xxxxxxxxxx xxxxxxxxx xxxxxxxxxxxx odůvodnění, x xxxx xxxxxxx, xx xxxx xxxxxxx xxxxxxx xxxxxxxx v xxx xxxxxxx.
3. Pokud xxxx xxxxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 písm. x) xxxx c) x Xxxxxx dospěje po xxxxxxxxxx s členskými xxxxx x xxxxxx, xx xxxxxxxx 6 není xxxxxxxxxx, x xxxxxxxx, že xxxx xxxxxxx xxxxxxxx xxx oznámení uvedené x xx. 15 písm. x), xxxxxxx o xxx xxxxxxxx.
4. Xxxxx xxxx xxxxxxxxxx xxxxxxx v případě xxxxxxxx x xx. 15 xxxx. x) xxxx xxxxx Xxxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 3, zveřejní agentura xxxx xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx x xxxxxxxx xxxxxxxxx xxxxxxxxx látky x xxxx xxxxxxxxx. Xxx účely xxxxxx xxxxxxxx xx xxxxxxxxxx xxxxx xx. 3x xxxx. 3 xxxxxxx xxxxxxxxxxx xxxxxxxx (ES) č. 1451/2007 xxxxxxxx xx zveřejnění xxxxx xxxxxx xxxxxxxx.
5. Kterákoli xxxxx, xxxxx xx xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx, xxx xxxx xxxxxx xxxxx xxxxxx 17 do šesti měsíců xxx xxx zveřejnění xxxxx xxxxxxxx 4.
6. X xxxxxxxxx xxxxxxxxx x xx. 15 xxxx. x) x x) xx xxxxxxxxx xxxxx a typu xxxxxxxxx xxxxxxxx za xxxxxxxxx účastníkem x xxxx xxxxxxxxx k xxxxxxx xxxxxxxx, xxxxx xxxx xxxxxxx tyto xxxxxxxx:
x) |
příslušná xxxxxx xxxxx xx xxx xxxxxxxx do programu xxxxxxxx; |
x) |
xxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx státu xxx xxxxxxxxxx xxxxxxx xxxxx xxx obsahuje xxxxxxx xxxxx, které xxxx xxxxxxxx xxx xxxxxxxxx xxxx xxxxxxxxx; |
c) |
xxxxxxxx, xxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxxx, xxxxx, xx má xxxxx x podporu xxxx xxxxxxxxx látky x xxxx xxxxxxxxx. |
Xxxxxx 17
Xxxxxx xxxxxxxx
1. Xxxxxxxx xxxxx xx. 14 odst. 2 x 3 xxxx xx. 16 xxxx. 5 xx xxxxxxxxxxx agentuře xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxxxxx xxxx být xxxxxxxxxx xx xxxxxxx XXXXXX. Xxxx xxxxxxxxx xxxxx uvedené x xxxxxxx X.
3. Pokud xxxx x xxxxxxx XX pro xxxxxxxx xxxxxxx xxxxx xxxxxx xxxxxxxxx xxxxxxxxx xxxxx, xxxxxxxxx xxxxxxxxxxx xxxxxxxx x xxxxx jím vybraného xxxxxxxxxxx orgánu, xxxxx xx xxxxxxxx v souladu x xxxxxxx 81 nařízení (EU) x. 528/2012, a poskytne xxxxxxx xxxxxxxxx xxxxxxxxxxx, xx xxxxxxxxx xxxxx xxxxxxxx x xxx, xx xxxxxxxxxxx xxxxxxx.
4. Xx obdržení oznámení x xxx xxxxxxx xxxxxxxx Xxxxxx x xxxxxxxxxxxx informuje x xxxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx (XX) x. 564/2013. Xxxxxxxx xxxxxxxxxxx neuhradí xxxxxxxx xx 30 xxx xx xxxxxxx xxxxxxx xxxxxxxxx, agentura xxxxxxxx xxxxxxx x xxxxxxx x xxx xxxxxxxxxxxx x Xxxxxx.
5. Xx xxxxxxxx xxxxxxxx xxxxxxxx do 30 xxx xxxxx, xxx xxxxxxxx xxxxxxxx xxxxxxxxxx uvedeným x xxxxxxxx 2. Xxxxx xxxxxxxx těmto xxxxxxxxxx xxxxxxxxxx, xxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxx v xxxxx 30 dnů, xxx své xxxxxxxx xxxxxxx xxxx xxxxxxx. Xx xxxxxxxx xxxx 30xxxxx xxxxx xxxxxxxx xx 30 xxx xxx xxxxxxxx, že xxxxxxxx xxxxxxxx požadavkům xxxxxxxx 2, xxxx xxxxxxxx xxxxxxx, x xxx xxxxxxxxxx xxxxx xxxxxxxxxxxx x Xxxxxx.
6. X xxxxxxx s článkem 77 nařízení (XX) x. 528/2012 proti xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 4 xxxx 5 podat xxxxxxx xxxxxxxxxx.
7. Xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxx xxxxxxxx 5:
x) |
x xxxxxxx, xx xxxx xxxxxxxx předloženo xxxxx xx. 14 odst. 2 xxxx 3, agentura xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx x xxxxxxxxx xxxxxxxx se xxxxxxxxxx xxxxxxxxx a xxxxxxxx identity xxxxx; |
x) |
x xxxxxxx, že oznámení bylo xxxxxxxxxx podle čl. 16 xxxx. 5, xxxxxxxx xxxxxxxxxx xxxxxxxxx Komisi, xx xxxxxxxxxx xxxx xxxxxxxx. |
Xxxxxx 18
Xxxxxxxx do xxxxxxxx xxxxxxxx
Xxxxx je xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxxx xx xxxxxxxxx x xxxxxxx x xx. 16 xxxx. 6 xxxx xxxxx xxxxxxxx xxxxxxxxx Komisi x dodržení xxxxxxxxx x xxxxxxx x xx. 17 xxxx. 7 xxxx. x), xxxxxx Xxxxxx kombinaci látky x xxxx přípravku do xxxxxxxx xxxxxxxx.
Xxxxxx 19
Informace o xxxxxxx, xxxxx xxxxxx xxxxxx podporovány v xxxxx programu xxxxxxxx
Xxxxx xxxxxx xx xxxxx xxxxxxxxx x xx. 16 xxxx. 5 obdrženo xxxxx xxxxxxxx nebo xxxxx xxxx oznámení xxxxxxx xx xxxxxxxx xxxxxx xxxxxxx a následně xxxxxxxxx xxxxxxxxx xxxxx xx. 17 odst. 4 xxxx 5, agentura o tom xxxxxxxxx xxxxxxx státy xxxxxxxxxxxxxxx xxxxxxxxx x xxxxxxxx xxxx informaci elektronickou xxxxxx.
Xxxxxx 20
Xxxxxxxxxx Xxxxxx x xxxxxxx, xxxxx xxxxxx nadále podporovány x xxxxx programu xxxxxxxx
Xxxxxx připraví xxxxx xxxxxxxxxx o neschválení xxxxx čl. 89 odst. 1 xxxxxxx pododstavce xxxxxxxx (XX) x. 528/2012 x xxxxxx xxxxxxxxx:
x) |
xxxxx agentura xxxxxxxxx Xxxxxx x xxxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xx. 12 xxxx. 3 xxxxxx xxxxxxxx; |
b) |
pokud xxxxx osoba xxxxxxxx xxxxxxxx xx xxxxxxx stanovených x xx. 14 odst. 2 xxxx 3 xxxxxx xxxxxxxx xxxx pokud xxxx xxxxxxxx xxxxxxxxxx a zamítnuto xxxxx xx. 17 xxxx. 4 xxxx 5; |
x) |
xxxxx xxxx xxxxxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx x xx. 14 xxxx. 2 xxxx 3 tohoto xxxxxxxx a byly xxxxxxxx xxxxxxxxx podle čl. 17 xxxx. 5 xxxxxx xxxxxxxx, xxx xxxxxxxx látky x xxxxxxxx xxxxxxxx xxxxx xxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX tohoto xxxxxxxx. |
X xxxxxxx xxxxxxxx x xxxxxx pododstavci xxxx. x) xx xxxxx xxxxxxxxxx o xxxxxxxxxxx xxxxxxxx xx xxxxxx xxxxx, xx xxxxxx xx vztahuje xxxxxxxxx xxxxxxxx x xxxxxxx XX xxxxxx xxxxxxxx, avšak xxxxxx xxxxxxxx xxxx xxxxxxxx xxxxxxxxxx x xxxxxxxxx.
XXXXXXXX 4
PŘECHODNÁ XXXXXXXX
Xxxxxx 21
Xxxxxxxxx xxxxxxxx xxx xxxxx uvedené x&xxxx;xxxxxx&xxxx;15
1.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx pokračovat x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx xxxx xxxxx xxxxxxxx na trh x&xxxx;xxxxxxxxx xxxxxxxxxx xxxxxxxxx, xxxxx xxxxxxx xx stávající xxxxxx xxxxx xxxxxxx x xx. 15 xxxx. b) a x), xxxx látku xxxxxxxx nebo x xx xxxxxx. X xxxxxx xxxxxxxxx:
x) |
xxxxx xxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx na trh s účinkem xx&xxxx;24 měsíců po xxxx xxxxxx tohoto xxxxxxxx x&xxxx;xxxxxxxx; |
x) |
xxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxx xxxx využívány xx&xxxx;30 měsíců xx xxx xxxxxx xxxxxx xxxxxxxx x&xxxx;xxxxxxxx. |
2.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx systému xxxx praxe dodávání xx&xxxx;xxx x&xxxx;xxxxxxxxx biocidního xxxxxxxxx, xxxxx xxxxxxx xx xxxxxxxxx xxxxxx xxxxx xxxxxxx x xx. 15 písm. x), tuto xxxxx xxxxxxxx xxxx x xx vzniká. X xxxxxx xxxxxxxxx:
x) |
xxxxx být xxxxxxxx xxxxxxxxx nadále xxxxxxx xx&xxxx;xxx s účinkem xx&xxxx;24 xxxxxx xx xx x dále xxxxxxxxx xxxxxxxx, xxxxx xxxxxxx xxxxxxx:
|
b) |
stávající xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxx xxxx xxxxxxxxx xx&xxxx;30 měsíců xx té x xxxx xxxxxxxxx xxxxxxxx, xxxxx xxxxxxx xxxxxxx:
|
3.&xxxx;&xxxx;&xxxx;Xxxxxxx stát xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx svého xxxxxxxxxxx xxxxxxx xxxx xxxxx xxxxxxxx na trh x&xxxx;xxxxxxxxx xxxxxxxxxx přípravku, xxxxx xxxxxxx xx xxxxxxxxx účinné xxxxx xxxxxxxxxx agenturou xxxxx xx. 16 xxxx. 4 xxx xxxxxxxxx xxx xxxxxxx, tuto xxxxx obsahuje xxxx x xx vzniká. X xxxxxx xxxxxxxxx:
x) |
xxxxx xxx biocidní přípravek xxxxxx dodáván xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;xxxxxxxx xxxxxx xx datu, xxx xxxxxxxx provedla xxxxxxxxxxxx xxxxxxxxxx xxxxx článku 19 a |
b) |
stávající xxxxxx xxxxxxxxxx přípravku xxxxx xxx xxxx xxxxxxxxx xx&xxxx;xxxxxxxx měsíců po xxxx xxxxxxxxx zveřejnění. |
Xxxxxx 22
Xxxxxxxx použití
1. Xxxx xx dotčen čl. 55 xxxx. 1 xxxxxxxx (EU) x. 528/2012, do osmnácti xxxxxx xx xxxx xxxxxxxxxx o neschválení xxxxxxxxx xxxxxx látky, xxxxx xxxxxxx xxxx xxxxxxxx tuto xxxxxxxxx xxxxxxx látku za xxxxxxxxx x xxxxxx xxxxxxxxx x xx. 5 xxxx. 2 prvním pododstavci xxxx. b) nebo x) nařízení (XX) x. 528/2012, tento členský xxxx xxxx xxxxxxxxx Xxxxxx odůvodněnou xxxxxx x xxxxxxxx xx xx. 89 xxxx. 2 xxxxxxx pododstavce xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx členský xxxx xxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxx prostřednictvím rejstříku. Xxxxx žádost obsahuje xxxxxxx xxxxxxxxx, žádající xxxxxxx stát musí xxxxxxx xxxxxxxxx nedůvěrné xxxxx.
3. Xxxxxxxx xxxxxxxx xxxxxx xxxx xxxxxxxx nedůvěrnou xxxxx elektronickými prostředky. Xxxxxxx státy xxxx xxxx osoby xxxxx xxxxx připomínky ve lhůtě 60 dnů xx xxxxxxxxxx.
4. Xx xxxxxxx xxxxxxxxxx xxxxxxxxxx xxxx Xxxxxx xxxxxxx xxxxxxxx xx xx. 89 xxxx. 2 xxxxxxx xxxxxxxxxxx xxxxxxxx (XX) č. 528/2012, xxxxx umožní uvádět xxxxxxxx přípravky, jež xxxxxxxxx z xxxx xxxxx, xxxxxxxx xx xxxx z xx xxxxxxxx, xx xxx xxxxxxxxxx xxxxxxxxx xxxxx x xxxxxxxx je v daném xxxxxxxx xxxxx x xxxxxxx x xxxxxxxxxxxxxx xxxxxxxx xxxxxxxx x x xxxxxxxx podmínek xxxxxxxx 5 x xxxxxxxxx xxxxxxx xxxxxxxx uložených Xxxxxx.
5. Xxxxxxx xxxx, jemuž xx xxxxxxxx xxxxxxxx:
x) |
zajistí, xx xxxxx xxxxxxxxx xxxx omezeno xx xxxxxx případy x xxxxxxx xxxx, xxx xxxx xxxxxx xxxxxxxx xxxxxxxx 1; |
x) |
xxxxxx vhodná xxxxxxxx xx xxxxxxxx xxxxx, xxx xxxxxxxx minimalizaci xxxxxxxx xxxxxxx, zvířat xxxx xxxxxxxxx prostředí; |
c) |
xxxxxxx, aby xx hledala alternativní xxxxxx xxxx xxx xxxx včas xxxx xxxxxxxxx platnosti xxxxxxxx xxxxxxxxxx xxxxxx x xxxxxxxxx xxxxxx xxxxx x xxxxxxx xxxxxxx 7 xxxxxxxx (XX) č. 528/2012. |
XXXXXXXX 5
XXXXXXXXX XXXXXXXXXX
Xxxxxx 23
Xxxxxxx
Xxxxxxx xx nařízení (XX) č. 1451/2007.
Xxxxxx xx zrušené xxxxxxxx xx xxxxxxxx za xxxxxx xx xxxx xxxxxxxx.
Xxxxxx 24
Xxxxx v xxxxxxxx
Xxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxxxxxx xxxx xx vyhlášení x Xxxxxxx xxxxxxxx Xxxxxxxx unie.
Xxxx xxxxxxxx xx xxxxxxx x xxxxx xxxxxxx a xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx xxxxxxx.
V Bruselu xxx 4. srpna 2014.
Xx Xxxxxx
předseda
Xxxx Xxxxxx XXXXXXX
(1) Úř. věst. L 167, 27.6.2012, s. 1.
(2)&xxxx;&xxxx;Xxxxxxxx Xxxxxx (XX) x. 1451/2007 xx xxx 4. prosince 2007 x xxxxx xxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx uvedeného x xx. 16 xxxx. 2 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx 98/8/XX x uvádění xxxxxxxxxx xxxxxxxxx xx xxx (Xx. věst. X 325, 11.12.2007, x. 3).
(3)&xxxx;&xxxx;Xxxxxxxx Evropského parlamentu x Xxxx 98/8/XX xx dne 16. xxxxx 1998 x xxxxxxx xxxxxxxxxx xxxxxxxxx xx xxx (Xx. xxxx. X 123, 24.4.1998, x. 1).
(4) Rozsudek Xxxxxxxx xxxxx (xxxxxxx senátu) xx xxx 1. xxxxxx 2012 (žádost o xxxxxxxxxx x předběžné xxxxxx: Landgericht Hamburg – Německo) – Xöxx GmbH xxxxx Xxxxx XxxX (xxxxxxx xxxxxxxxxx přípravků xx xxx – směrnice 98/8/XX – čl. 2 odst. 1 xxxx. x) – xxxxx „xxxxxxxx přípravky“ – xxxxxxxxx, který xxxxxxxxx vločkování xxxxxxxxxx xxxxxxxxx, xxxx xx xxxx, odpuzuje xxxx xxxxxxxxxxx), C-420/10.
(5)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Xxxxxx (XX) x.&xxxx;88/2014 xx xxx 31.&xxxx;xxxxx 2014, xxxxxx xx stanoví xxxxxx pro změnu xxxxxxx I nařízení Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (EU) x.&xxxx;528/2012 o dodávání xxxxxxxxxx xxxxxxxxx xx xxx x&xxxx;xxxxxx používání (Xx. xxxx. X 32, 1.2.2014, x. 3).
(6)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx parlamentu x Rady (XX) x. 1272/2008 ze xxx 16. xxxxxxxx 2008 o xxxxxxxxxxx, xxxxxxxxxx x balení xxxxx x xxxxx, x xxxxx a xxxxxxx směrnic 67/548/XXX x 1999/45/ES x x změně xxxxxxxx (XX) x. 1907/2006 (Xx. xxxx. X&xxxx;353, 31.12.2008, x. 1).
(7) Prováděcí xxxxxxxx Xxxxxx (XX) x.&xxxx;564/2013 xx xxx 18. června 2013 x&xxxx;xxxxxxxxxx a platbách xxxxxxxxx Xxxxxxxx agentuře xxx xxxxxxxx xxxxx xxxxx xxxxxxxx Evropského xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;528/2012 x&xxxx;xxxxxxxx xxxxxxxxxx přípravků xx trh x&xxxx;xxxxxx xxxxxxxxx (Xx.&xxxx;xxxx.&xxxx;X 167, 19.6.2013, x. 17).
(8)&xxxx;&xxxx;Xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 1907/2006 xx xxx 18. prosince 2006 o xxxxxxxxxx, xxxxxxxxx, xxxxxxxxxx x xxxxxxxxx xxxxxxxxxx xxxxx, x xxxxxxx Evropské xxxxxxxx xxx xxxxxxxx xxxxx, o xxxxx xxxxxxxx 1999/45/XX x x xxxxxxx nařízení Xxxx (XXX) x.&xxxx;793/93, xxxxxxxx Komise (XX) x. 1488/94, xxxxxxxx Xxxx 76/769/XXX x xxxxxxx Xxxxxx 91/155/XXX, 93/67/XXX, 93/105/XX a 2000/21/XX (Xx. xxxx. X 396, 30.12.2006, x. 1).
XXXXXXX I
Xxxxxxxxx požadované xxx xxxxxxxx xxxxx xxxxxx 17
Xxxxxxxx podle xxxxxx 17 xxxxxxxx xxxx informace:
1) |
xxxxx, že látka xx xxxxxxxxx účinnou xxxxxx ve smyslu čl. 3 xxxx. 1 xxxx. x) nařízení (XX) x. 528/2012; |
2) |
údaje x xxxx/xxxxxx xxxxxxxxx, xx xxxxx/x se oznámení xxxxxxxx; |
3) |
xxxxxxxxx o všech xxxxxxxx, xxxxx xxxx zadány xxx xxxxx žádosti x xxxxxxxxx xx xxxxxxxx xx xxxxxxx X xxxxxxxx (XX) x. 528/2012, xxxxx i očekávané xxxxx jejich dokončení; |
4) |
xxxxxxxxx xxxxxxx x xxxxxxxx
|
5) |
xxxxx xxxx xxxx xxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 xxxx. a), xxxxx, že látka xxxx xx xxxx jako xxxxxx xxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxxxx xx xxxxxxxxxxx xxxx xxxxxxxxx v den xxxxxxxx xxxx xxxxxxxxxx rozhodnutí xxxx xxxxxx xxxxxxxxx xx xxxxxxxx písmenu. |
XXXXXXX XX
XXXXXXXXX XXXXX X XXXX XXXXXXXXX ZAŘAZENÉ XX XXXXXXXX XXXXXXXX DNE 4. XXXXX 2014
XXXX 1
Xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx podporované xx xxx 4. xxxxx 2014, x xxxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxxxxxx xxx xxxx, xxxxx xxxx xxxxxxxx xxxxxxx x xxxxxxxxx 1017 a 1019.
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5-{[2-(2-xxxxxxxxxxxx)xxxxxx]xxxxxx}-6- xxxxxx-1,3-xxxxxxxxxxx (xxxxxxxxxxxxxxxx/XXX) |
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xxxxxx-2-xx |
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200-712-3 |
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propan-1-ol |
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ethylenoxid |
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kyselina xxxxxxxxx |
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201-069-1 |
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X-(+)-xxxxxx kyselina |
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2-isopropenyl-8,9-dimethoxy-1,2,6,6a,12,12a-hexahydrochromeno[3,4-b]furo[2,3-h]chromen-6-on (rotenon) |
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2-fenoxyethan-1-ol |
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123-03-5 |
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x |
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179 |
xxxx xxxxxxxx |
XX |
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 |
xxxxxxxxxxxxxx, xxxxx xxx (sodná sůl xxxxxxxxxxxxxxx – xxxxxxxxx X) – (X-xxxxx-4-xxxxxxxxxxxx-1-xxxxxxxxxx |
ES |
204-854-7 |
127-65-1 |
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x |
x |
x |
x |
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187 |
kalium-dimethyldithiokarbamát |
XX |
204-875-1 |
128-03-0 |
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x |
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x |
x |
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188 |
xxxxxxx-xxxxxxxxxxxxxxxxxxxxxx |
XX |
204-876-7 |
128-04-1 |
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x |
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x |
x |
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195 |
natrium-bifenyl-2-olát |
XX |
205-055-6 |
132-27-4 |
x |
x |
x |
x |
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x |
x |
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x |
x |
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x |
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198 |
X-[(xxxxxxxxxxxxxx)xxxxxxxx]xxxxxxxx (xxxxxx) |
XX |
205-088-6 |
133-07-3 |
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x |
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x |
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206 |
xxxxxx |
XX |
205-286-2 |
137-26-8 |
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x |
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210 |
xxxxxx-xxxxxxx |
XX |
205-293-0 |
137-42-8 |
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x |
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x |
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227 |
2-(xxxxxxx-4-xx)xxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
205-725-8 |
148-79-8 |
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x |
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x |
x |
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235 |
xxxxxx |
XX |
206-354-4 |
330-54-1 |
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x |
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x |
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239 |
karbamonitril |
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) |
BE |
208-576-7 |
533-74-4 |
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x |
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x |
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279 |
X-[(xxxxxxxxxxxxxxxxxx)xxxxxxxx]-X′,X′-xxxxxxxx-X-(4-xxxxxxxxxxx)xxxxxxxxxx (xxxxxxxxxxxx) |
XX |
211-986-9 |
731-27-1 |
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x |
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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 |
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289 |
thiokyanatan xxxxx |
XX |
214-183-1 |
1111-67-7 |
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x |
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292 |
[(1,3-xxxxx-1,3,4,5,6,7-xxxxxxxxx-2X-xxxxxxxx-2-xx)xxxxxx]-xxxxx-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxx-xxxxxxxxxxxx) |
XX |
214-619-0 |
1166-46-7 |
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x |
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958 |
xxxxxxxx xxxxxxxx/xxxxxxxxxxx xxxxx/xxxxxx xxxxx |
XX |
215-137-3 |
1305-62-0 |
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x |
x |
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959 |
xxxx xxxxxxxx/xxxxx/xxxxxx vápno/nehašené xxxxx |
XX |
215-138-9 |
1305-78-8 |
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x |
x |
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306 |
xxxx xxxxx |
XX |
215-270-7 |
1317-39-1 |
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x |
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315 |
xxxxx-2-xx-xxxxxxx |
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 (diamin) |
PT |
219-145-8 |
2372-82-9 |
|
x |
x |
x |
|
x |
|
x |
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x |
x |
x |
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336 |
X,X′-xxxxxxxx-2,2′-xxxxxxxxxxxxxxxxxxxxxx (XXXXX) |
XX |
219-768-5 |
2527-58-4 |
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x |
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339 |
1,2-xxxxxxxxxxxxxxx-3(2X)-xx (BIT) |
XX |
220-120-9 |
2634-33-5 |
|
x |
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x |
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x |
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x |
x |
x |
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341 |
2-xxxxxxxxxxxxxxxxxxxxxxxxxx-3(2X)-xx (XXX) |
XX |
220-239-6 |
2682-20-4 |
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x |
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x |
x |
x |
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346 |
xxxxxxx-xxxxxxxxxxxxxxxxxx xxxxxxxx |
XX |
220-767-7 |
51580-86-0 |
|
x |
x |
x |
x |
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x |
x |
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345 |
xxxxxxx-xxxxxxxxxxxxxxxxxx |
XX |
220-767-7 |
2893-78-9 |
|
x |
x |
x |
x |
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x |
x |
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348 |
xxxxx(xxxxxxxxx)xxxxxxxxxxxxxxx-xxxxx-xxxxxx (MES) |
XX |
221-106-5 |
3006-10-8 |
x |
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354 |
xxxxxxxxx |
XX |
222-182-2 |
3380-34-5 |
x |
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359 |
(xxxxxxxxxxxx)xxxxxxxxxx (xxxxxxx xxxxxxxx xxxxxxxxxxxxxx x xxxxxxxxxxxxxxxx (XXXxxx)) |
XX |
222-720-6 |
3586-55-8 |
|
x |
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x |
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x |
x |
x |
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365 |
xxxxxxx-2-xxxxx-1-xxxx, xxxxx xxx (pyrithion sodný) |
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) |
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) |
ES |
226-408-0 |
5395-50-6 |
|
x |
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x |
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x |
x |
x |
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387 |
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) |
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 |
SE |
231-131-3 |
7440-22-4 |
|
x |
|
x |
x |
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x |
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|
403 |
xxx |
FR |
231-159-6 |
7440-50-8 |
|
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x |
|
405 |
xxxx xxxxxxxx |
XX |
231-195-2 |
7446-09-5 |
|
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x |
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424 |
xxxxxx xxxxx |
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 |
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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 |
peroxid 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 (EDHO) |
PL |
231-810-4 |
7747-35-5 |
|
|
|
|
|
x |
|
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|
x |
|
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|
450 |
dusičnan xxxxxxxx |
SE |
231-853-9 |
7761-88-8 |
x |
|
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|
453 |
xxxxxxxxxxxxx xxxxx |
XX |
231-892-1 |
7775-27-1 |
|
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|
x |
|
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|
455 |
xxxxxxxx xxxxxxxx |
XX |
231-908-7 |
7778-54-3 |
|
x |
x |
x |
x |
|
|
|
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|
x |
|
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|
457 |
xxxxx |
XX |
231-959-5 |
7782-50-5 |
|
x |
|
|
x |
|
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|
x |
|
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|
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|
458 |
síran xxxxxx |
UK |
231-984-1 |
7783-20-2 |
|
|
|
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|
x |
x |
|
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|
473 |
xxxxxxxxxx x xxxxxxxxxxx |
XX |
232-319-8 |
8003-34-7 |
|
|
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|
x |
x |
|
|
491 |
xxxx chloričitý |
XX |
233-162-8 |
10049-04-4 |
|
x |
x |
x |
x |
|
|
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|
x |
x |
|
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|
|
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|
494 |
2,2-xxxxxx-2-xxxxxxxxxxxx (XXXXX) |
XX |
233-539-7 |
10222-01-2 |
|
x |
|
x |
|
x |
|
|
|
|
x |
x |
x |
|
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|
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|
501 |
xxxxxxxxxxx |
XX |
234-232-0 |
10605-21-7 |
|
|
|
|
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|
x |
|
x |
x |
|
|
|
|
|
|
|
|
515 |
xxxxxx amonný |
SE |
235-183-8 |
12124-97-9 |
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
522 |
zink-1-oxo-1λ5-pyridin-2-thiolát |
XX |
236-671-3 |
13463-41-7 |
|
x |
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
x |
|
524 |
xxxxxxxxxxxxxxx-xxxxxxxxxxxxxxxx |
XX |
237-030-0 |
13590-97-1 |
|
|
|
|
|
x |
|
|
|
|
x |
|
|
|
|
|
|
|
526 |
kalium-bifenyl-2-olát |
ES |
237-243-9 |
13707-65-8 |
|
|
|
|
|
x |
|
|
x |
x |
|
|
x |
|
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|
529 |
xxxxxxxxxxxxxxx |
NL |
237-601-4 |
13863-41-7 |
|
|
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|
x |
|
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|
531 |
(xxxxxxxxx)xxxxxxxx |
XX |
238-588-8 |
14548-60-8 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
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|
|
534 |
xxx(1-xxxxxxxxxxxxxx-2(1X)-xxxxxxxx-X,X)xxxxxxx komplex (xxxxxxxxx mědi) |
SE |
238-984-0 |
14915-37-8 |
|
|
|
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|
|
|
|
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|
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|
x |
|
541 |
xxxxxxx-4-xxxxx-3-xxxxxxxxxxxxx |
FR |
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) |
XX |
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 |
[(xxxxxxxxxxxx-2-xx)xxxxxxxx]xxxxxx-xxxxxxxxxx (XXXXX) |
X |
244-445-0 |
21564-17-0 |
|
|
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
|
|
562 |
[2-xxxxxx-4-xxx-3-(xxxx-2-xx-1-xx)xxxxxxxxx-2-xx-1-xx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (prallethrin) |
XX |
245-387-9 |
23031-36-9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
563 |
kalium-(E,E)-hexa-2,4-dienoát (xxxxxx xxxxxxxx) |
XX |
246-376-1 |
24634-61-5 |
|
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
|
566 |
α, α′,α′′-xxxxxxxxxxxxxxxxxx-1,3,5-xxxxxxx-1,3,5-xxxxxxxxxx (HPT) |
AT |
246-764-0 |
25254-50-6 |
|
x |
|
|
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
571 |
2-xxxxxxxxxxxxxxxxxxxxxxxxx-3-xx (XXX) |
XX |
247-761-7 |
26530-20-1 |
|
|
|
|
|
x |
x |
|
x |
x |
x |
|
x |
|
|
|
|
|
577 |
xxxxxxxx(xxxxxxxxx)[3-(xxxxxxxxxxxxxxx)xxxxxx]xxxxxxx-xxxxxxx |
ES |
248-595-8 |
27668-52-6 |
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
578 |
N2-terc-butyl-N4-cyklopropyl-6-(methylsulfanyl)-1,3,5-triazin-2,4-diamin (xxxxxxxx) |
XX |
248-872-3 |
28159-98-0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
588 |
xxxxxxxxx-5,5-xxxxxxxxxxxxxxxxxxxx-2,4-xxxx (BCDMH/bromchlordimethylhydantoin) |
NL |
251-171-5 |
32718-18-6 |
|
x |
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
590 |
3-(4-isopropylfenyl)-1,1-dimethylmočovina/isoproturon |
XX |
251-835-4 |
34123-59-6 |
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
|
|
|
|
597 |
1-[2-(xxxxxxxx)-2-(2,4-xxxxxxxxxxxx)xxxxx]xxxxxxxx (imazalil) |
XX |
252-615-0 |
35554-44-0 |
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
599 |
X-[(6-xxxxx-2-xxxxxxxxxx[4,5-x]xxxxxxx-3(2X)-xx)xxxxxx]-X,X-xxxxxxxx-xxxxxxxxxxxxx (xxxxxxxxxxx) |
XX |
252-626-0 |
35575-96-3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
600 |
2-xxxx-2-(xxxxxxxxxx)xxxxxxxxxxxxxx (DBDCB) |
XX |
252-681-0 |
35691-65-7 |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
961 |
xxxx vápenato-hořečnatý/dolomitické xxxxx |
XX |
253-425-0 |
37247-91-9 |
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
962 |
xxxxxxxx vápenato-hořečnatý/hydratované dolomitické xxxxx |
XX |
254-454-1 |
39445-23-3 |
|
x |
x |
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606 |
[(3-xxxxxxxxxxx)xxxxxxxxxx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (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 |
cis- 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 (xxxxxxxxxx) |
XX |
258-067-9 |
52645-53-1 |
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x |
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x |
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618 |
[1-xxxxxxx-2-xxxxxxxxxx-2-xx-1-xx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (xxxxxxxxxx) |
BE |
259-154-4 |
54406-48-3 |
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x |
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619 |
3-xxxxxxx-2-xx-1-xx-X-xxxxxxxxxxxxx (XXXX) |
XX |
259-627-5 |
55406-53-6 |
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x |
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x |
x |
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x |
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620 |
xxxxxxxx(xxxxxxxxxxxxx)xxxxxxxxx-xxxxxx (2:1) (THPS) |
XX |
259-709-0 |
55566-30-8 |
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x |
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x |
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x |
x |
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628 |
(±)-1-{[2-(2,4-xxxxxxxxxxxx)-4-xxxxxx- 1,3-xxxxxxxx-2-xx]xxxxxx}-1X-1,2,4-xxxxxxx (propikonazol) |
XX |
262-104-4 |
60207-90-1 |
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x |
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635 |
xxxxxxxxxxxxxxxxxxxxxxxxxxxxx kokosového xxxxx (XXXXX/XXXX) |
XX |
263-038-9 |
61789-18-2 |
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x |
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648 |
4,5-xxxxxxx-2-xxxxxxxxxxxxxxx-3(2X)-xx (4,5-xxxxxxx- 2-xxxxx-2X-xxxxxxxxxx-3-xx (DCOIT)) |
N |
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) |
XX |
264-980-3 |
64628-44-0 |
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x |
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656 |
bis(5-methyloxazolidin-3-yl)methan (xxxxxxxxxx/XXX) |
XX |
266-235-8 |
66204-44-2 |
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x |
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x |
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x |
x |
x |
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657 |
6-(xxxxxxxxxxxxxxxx)-1,3,5-xxxxxxx-2,4-xxxxxx (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 (xxxxxxxxxx) |
XX |
269-855-7 |
68359-37-5 |
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x |
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667 |
xxxxx(X12-18)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXX (X12-18)) |
XX |
269-919-4 |
68391-01-5 |
x |
x |
x |
x |
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x |
x |
x |
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x |
671 |
xxxxx(X12-16)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXX/XXX (X12-X16)) |
XX |
270-325-2 |
68424-85-1 |
x |
x |
x |
x |
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x |
x |
x |
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x |
673 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxxx (DDAC) (X8-10) |
XX |
270-331-5 |
68424-95-3 |
x |
x |
x |
x |
|
x |
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x |
x |
x |
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690 |
alkyl(C12-C18)benzyl(dimethyl)amoniové xxxx 1,1-xxxxx-1λ-1,2-xxxxxxxxxxxxxxx-3(2X)-xxx (XXXXX) |
XX |
273-545-7 |
68989-01-5 |
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x |
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x |
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691 |
xxxxxxx-X-(xxxxxxxxxxxxx)xxxxxxxx |
XX |
274-357-8 |
70161-44-3 |
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x |
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692 |
alkyl(C10-C16)dimethylaminoxidy |
PT |
274-687-2 |
70592-80-2 |
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x |
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693 |
bis(peroxosíran)-bis(síran) xxxxxxxxxxxxx |
XX |
274-778-7 |
70693-62-8 |
|
x |
x |
x |
x |
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701 |
xxxxxxxxx-xxxxxxxxxxxxxxxx xxxxxxxxxx (MMPP) |
PL |
279-013-0 |
84665-66-7 |
|
x |
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1015 |
margosa, Xxxxxxxxxxx xxxxxx, xxxxxxx |
XX |
283-644-7 |
84696-25-3 |
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x |
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724 |
xxxxx(X12-X14)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXX (X12-X14)) |
XX |
287-089-1 |
85409-22-9 |
x |
x |
x |
x |
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x |
x |
x |
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x |
725 |
xxxxx(X12-X14)xxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXXX (X12-X14)) |
XX |
287-090-7 |
85409-23-0 |
x |
x |
x |
x |
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x |
x |
x |
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x |
731 |
xxxxxxxxx xxxxxxxxxxxx, Xxxxxxxxxxxxx xxxxxxxxxxxxxxxx, výtažek |
ES |
289-699-3 |
89997-63-7 |
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x |
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744 |
levandule 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) |
PT |
401-400-1 |
86479-06-3 |
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x |
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779 |
xxxxxxx produkty xxxxxxxxx xxxxxxxx a X-xxxxx(X12-X14)xxxxxx-1,2-xxxxxxx (glukoprotamin) |
XX |
403-950-8 |
164907-72-6 |
|
x |
|
x |
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785 |
6-xxxxxxxxxxxxxxxxxxxxxxx xxxxxxxx (XXX) |
XX |
410-850-8 |
128275-31-0 |
x |
x |
x |
x |
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791 |
2-xxxxx-1,2-xxxxxxxxxxxx-3(2X)-xx (XXXX) |
XX |
420-590-7 |
4299-07-4 |
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x |
x |
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x |
x |
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x |
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792 |
xxxxxxx xxxxxxxxxxxxxxxxxxx (XXXX) |
XX |
420-970-2 |
92047-76-2 |
x |
x |
|
x |
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811 |
xxxxxxxxxxxxxxxxxxx stříbrno-sodno-zirkoničitý |
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 (ikaridin) |
XX |
423-210-8 |
119515-38-7 |
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x |
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797 |
1-((Z)-3-chlorallyl)-3,5,7-triaza-1-azoniaadamantanchlorid (xxx-XXXX) |
XX |
426-020-3 |
51229-78-8 |
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x |
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x |
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800 |
{[2,5-xxxxx-3-(xxxx-2-xx-1-xx)xxxxxxxxxxxx-1-xx]xxxxxx}-2,2-xxxxxxxx-3- (2-methylprop-1-en-1-yl)cyklopropan- 1-xxxxxxxxxx (xxxx xxxxxxxxxxxxx) (imiprothrin) |
XX |
428-790-6 |
72963-72-5 |
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x |
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790 |
5-xxxxx-2-(4-xxxxxxxxxxx)xxxxx (XXXX) |
XX |
429-290-0 |
3380-30-1 |
x |
x |
|
x |
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807 |
(X)-1-[(2-xxxxxxxxxxxx-5-xx)xxxxxx]-3-xxxxxx-2-xxxxxxxxxxxxx (xxxxxxxxxxxxx) |
XX |
433-460-1 |
210880-92-5 |
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x |
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952 |
Bacillus sphaericus 2362, xxxx XXXX-1743 |
IT |
mikroorganismus |
143447-72-7 |
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x |
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955 |
Bacillus xxxxxxxxxxxxx xxxxx. xxxxxxxxxxx, xxxx XX3X |
XX |
xxxxxxxxxxxxxxx |
není xxxxxxxxxx |
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x |
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957 |
Xxxxxxxx xxxxxxxx |
XX |
xxxxxxxxxxxxxxx |
xxxx relevantní |
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x |
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928 |
5-xxxxx-2-xxxxxxxxxxxxxxxx-3(2X)-xx (Xxxxxx 247-500-7) x 2-xxxxxxxxxxxxxxxx-3(2X)-xx (Xxxxxx 220-239-6), xxxx (3:1) (xxxx CMIT/MIT) |
XX |
xxxx |
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 |
xxxxxxx xxxxx (xxxxxxxx xxxxxx xxxxxxxx xxxxxxx x xxxxxxxxx sodného in xxxx) |
XX |
xxxx |
xxxx xxxxxxxxxx |
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x |
x |
x |
x |
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813 |
peroxyoktanová xxxxxxxx |
FR |
xxxx xxxxxxxxxx |
33734-57-5 |
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x |
x |
x |
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1014 |
xxxxxxxx xxxxxx |
XX |
není relevantní |
xxxx xxxxxxxxxx |
|
x |
|
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 |
xxxx xxxxxxxxxx |
188023-86-1 |
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x |
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931 |
xxxxxxxxxxxxxxxxxxxxxxx, X-X12-14(xx xxxxx xxxxxx), xxxxxxxx xxxxxx x xxxxxxxxxxxx kyselinou (Ampholyt 20) |
XX |
xxxx xxxxxxxxxx |
139734-65-9 |
|
x |
x |
x |
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152 |
xxxxxxxx xxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-ethyl-5-methylhydantoinu x xxxxxx a xxxxxxx (XXXXX) |
XX |
xxxx k dispozici |
xxxx x xxxxxxxxx |
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x |
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459 |
xxxxxxx xxxx xxxxx xxxxxxxxxxxx x xxxxxxxx xxxxxxxxxx |
XX |
xxxx x xxxxxxxxx |
xxxx x xxxxxxxxx |
x |
x |
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x |
x |
|
x |
x |
x |
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777 |
xxxxxxx xxxxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-ethyl-5-methylhydantoinu s chlorem (XXXXX) |
XX |
xxxx x xxxxxxxxx |
není x xxxxxxxxx |
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x |
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810 |
xxxxxxxxxxxxxx xxxx s xxxxxxx xxxxxxx |
XX |
xxxx x xxxxxxxxx |
308069-39-8 |
|
x |
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x |
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x |
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824 |
xxxxxxxx-xxxxxxxxx xxxxxx |
XX |
xxxx x xxxxxxxxx |
130328-20-0 |
|
x |
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x |
x |
|
x |
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x |
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1013 |
xxxxxxxx-xxxxxxx xxxxxx |
XX |
xxxx x xxxxxxxxx |
130328-19-7 |
|
x |
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x |
x |
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x |
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x |
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1017 |
xxxxxxx xxxxxxxxxxx xx xxxxx xxxxxxxxxx (xxxx xxxxxxxxxxxx xx xxxxx xxxxxxxxxx xxxxxxxx x primárními xxxxxxxxx xx xxxxxxxxxx) |
SE |
xxxx x xxxxxxxxx |
není x xxxxxxxxx |
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x |
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1019 |
xxxx xxxxxxxxx (xxxx xxxxxxxxxxxx xxxxxxx xxxxxxxx x xxxxxxxxxx) |
XX |
xxxx k dispozici |
68909-20-6 |
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x |
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831 |
křemelina |
XX |
xxxxxxxxx na xxxxxxx xxxxxxx |
61790-53-2 |
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x |
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854 |
(XX)-3-xxxx-2-xxxxx-4-xxxxxxxxxxxx-2-xxxx-(1X,3X;1X,3X)-2,2-xxxxxxx-3-(2-xxxxxxxxx-1-xxxx)-xxxxxxxxxxxxxxxxxxxxx (směs 4 xxxxxxx 1X xxxxx, 1X: 1X xxxxx, 1X: 1R xxx, 1X: 1X xxx, 1X 4:4:1:1) (x-xxxxxxxxx) |
XX |
xxxxxxxxx xx ochranu xxxxxxx |
231937-89-6 |
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x |
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855 |
(XX)-3-xxxxx-2-xxxxxx-4-xxxxxxxxxxxx-2-xx-1-xx-(1X,3X)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (směs 2 xxxxxxxxxxxxx) (xxxxxxxxxx) |
XX |
přípravek xx xxxxxxx rostlin |
260359-57-7 |
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x |
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848 |
X-[(6-xxxxx-3-xxxxxxx)xxxxxx]-X′-xxxx-X-xxxxxxxxxxxxxxxxxxx (xxxxxxxxxxx) |
BE |
přípravek xx ochranu rostlin |
160430-64-8 |
|
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x |
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835 |
xxxxxxxxxxxx/(X)-(3-xxxxxxxxxxx)xxxxxxxxxx-(X)-2-(4-xxxxxxxxxx)-3-xxxxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
xxxxxxxxx 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) |
BE |
přípravek na xxxxxxx rostlin |
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) |
PT |
přípravek xx xxxxxxx rostlin |
122453-73-0 |
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x |
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859 |
xxxxxxx X-xxxxxxxxxxxxxxxxx(XXXXXX 204-697-4) x (xxxxxxxxxxx)xxxxxxxx (EINECS 203-439-8)/xxxxxxxxx xxxxxxxxx xxxxxxx xxxxxx (XX Xxxxxxx) |
XX |
xxxxxxx |
25988-97-0 |
|
x |
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x |
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863 |
xxxx(xxxxxxxx-1,5-xxxxxxxxx-1,6-xxxx) (XXXX) |
FR |
xxxxxxx |
27083-27-8/32289-58-0 |
x |
x |
x |
x |
x |
x |
|
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x |
|
x |
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868 |
xxxx(xxxxxxxx-1,5-xxxxxxxxx-1,6-xxxx-xxxxxxxxxxxx) |
XX |
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) |
IT |
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) |
XX |
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 xxxx xxxx xxxxxxx xxxxxxxx
— |
xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxx x xxxxxxx xxxx, xxxxxx xxxxxxxxxx xxxxxxxxx, |
— |
xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx a typu přípravku xxxxxxxxx x xxxxxxx x xxxxx 1, xxxxx xxxx, xxxxx xxxx uvedeny v tabulce, x |
— |
xxxxxxxx nanoformy xxxxx xxxxxxxxx účinných xxxxx x xxxx xxxxxxxxx xxxxxxxxxxx xx 4. xxxxx 2014, x xxxxxxxx xxxx, které xxxx výslovně schváleny. |
Xxxxxxxxx xxxxx x xxxx přípravku x xxxxxxxxxxxxx xxxxxxxx xx této xxxxx xxxxx xxxxxxxxx xxxxxxxxxx x neschválení podle xxxxxx 20, xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxx xx xxxxxxxx měsíců xx xxxxxx tohoto xxxxxxxx x xxxxxxxx xxxxx xx. 14 odst. 3 xxxx xxxxx xx xxxxxx xxxxxxxx zamítnuto xxxxx xx. 17 odst. 4 xxxx 5.
Xxxxx xxxxxxx |
Název xxxxx |
Xxxxxxx xxxx zpravodaj |
Číslo ES |
Číslo XXX |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
17 |
18 |
19 |
21 |
22 |
1021 |
1,3-xxxxxxx-5,5-xxxxxxxxxxxxxxxxx (nově xxxxxxxxxx xxxxx položky 152) |
NL |
204-258-7 |
118-52-5 |
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x |
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166 |
xxxxxx(xxxxxxxxx)xxxxxxxxxxxxxxx-xxxxxxx (xxx položka 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 |
xxxxxx(xxxxxxxx)xxxxxxxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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205-352-0 |
139-08-2 |
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227 |
2-(thiazol-4-yl)benzimidazol (xxxxxxxxxxxx) |
XX |
205-725-8 |
148-79-8 |
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x |
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331 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxx (xxx xxxxxxx 949) |
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219-234-1 |
2390-68-3 |
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384 |
xxxxxxxx(xxxxxxx)xxxxxxx-xxxxxxx (viz položka 949) |
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226-901-0 |
5538-94-3 |
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399 |
xxxxxx(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxx (xxx 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 amorfní |
XX |
231-545-4 |
7631-86-9 |
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x |
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449 |
síran xxxxxxx |
XX |
231-847-6 |
7758-98-7 |
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x |
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1016 |
xxxxxxx xxxxxxxx |
XX |
232-033-3 |
7783-90-6 |
x |
x |
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x |
x |
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x |
x |
x |
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554 |
4-[(dijodmethyl)sulfonyl]-1-methylbenzen |
UK |
243-468-3 |
20018-09-1 |
|
x |
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587 |
xxxxx(xxxxxxxx)xxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 949) |
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251-035-5 |
32426-11-2 |
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601 |
xxxxxxxxxxxxxx(xxxxxxx-9-xx-1-xx)xxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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253-363-4 |
37139-99-4 |
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615 |
3-xxxxxxxxxxxx(1XX,3XX;1XX,3XX)-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (permethrin) |
IE |
258-067-9 |
52645-53-1 |
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x |
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637 |
alkyl(benzyl)dimethylamonium-chloridy (xxxxx xxxxxxx od xxxxxxxx kyselin xxxxxxxxxx xxxxx) (xxx položka 948) |
|
263-080-8 |
61789-71-7 |
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638 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (alkyl xxxxxxx xx mastných kyselin xxxxxxxxxx oleje) (xxx xxxxxxx 949) |
|
263-087-6 |
61789-77-3 |
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639 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (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 |
dialkyl(C6-C12)dimethylamonium-chloridy (xxx xxxxxxx 949) |
|
269-925-7 |
68391-06-0 |
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670 |
xxxxx(X8-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxx xxxxxxx 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 |
alkyl(C10-C16)dimethylaminoxidy |
PT |
274-687-2 |
70592-80-2 |
|
x |
|
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697 |
dialkyl(C8-C18)dimetylamonium-chloridy (xxx položka 949) |
|
277-453-8 |
73398-64-8 |
|
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1000 |
xxxxxxxxxx-xxx(xxxxxxxxxxxxxxxxx)xxxxxxxx xxxxxxxxxx |
XX |
279-013-0 |
14915-85-4 |
|
x |
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998 |
xxxxxxx xxxxxxx xxxx xxx z xxxxx xxxxxxxx Azadirachta xxxxxx xxxxxxxxxxx xxxxx x xxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxxxxx |
XX |
283-644-7 |
84696-25-3 |
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x |
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741 |
xxxxx(X8-X18)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxx (viz xxxxxxx 948) |
|
293-522-5 |
91080-29-4 |
|
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1020 |
1,3-xxxxxxx-5-xxxxx-5-xxxxxxxxxxxxxxxxxx-2,4-xxxx (nově xxxxxxxxxx xxxxx 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 dimethyl-sukcinátu x xxxxxxxxx vodíku (xxxxxxxx) |
XX |
432-790-1 |
xxxx relevantní |
|
x |
|
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|
923 |
alkyl(benzyl)dimethylamonium-chlorid/benzalkonium-chlorid (xxx xxxxxxx 948) |
|
xxxx |
8001-54-5 |
|
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949 |
(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx xxxx -xxxxxx-xxxxxxx) (alkyly (X6-X18) nasycené a xxxxxxxxxx, xxxxxxxx xx xxxxxxxx xxxxxxx loje, xxxxxxxxxx xxxxx x xxxxxxxx oleje) (XXXX) |
XX |
směs xxxxx xxxxxxxxx x xxxxxxx XXXXXX |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
|
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x |
|
x |
x |
x |
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950 |
alkyltrimethylamonium-chloridy, -xxxxxxx nebo -xxxxxx-xxxxxxx) (xxxxxx (X8-X18) xxxxxxxx x xxxxxxxxxx, xxxxxxxx xx xxxxxxxx xxxxxxx xxxx, kokosového xxxxx x xxxxxxxx xxxxx) (XXXX) |
XX |
xxxx xxxxx xxxxxxxxx x seznamu XXXXXX |
xxxx xxxxxxxxxx |
|
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x |
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948 |
xxxxxx(xxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx xxxx -xxxxxxxxx) (xxxxxx (X8-X22) xxxxxxxx a xxxxxxxxxx, xxxxxxxx od xxxxxxxx xxxxxxx xxxx, kokosového xxxxx a sójového xxxxx) (XXX) |
XX |
xxxx xxxxx xxxxxxxxx x seznamu XXXXXX |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
|
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x |
|
x |
x |
x |
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|
849 |
3-xxxxxxxxxxxx-(1X,3XX)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxxxxxx) |
IE |
není xxxxxxxxxx |
188023-86-1 |
|
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x |
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1001 |
xxxxx(X12-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxx než xxxxx xxxxxxxxx xxx položku 671) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
|
x |
x |
x |
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|
x |
1002 |
alkyl(C12-C18)benzyl(dimethyl)amonium-chloridy(jiné xxx xxxxx xxxxxxxxx xxx xxxxxxx 667) |
IT |
xxxx xxxxxxxxxx |
xxxx relevantní |
x |
x |
x |
x |
|
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|
x |
x |
x |
|
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|
x |
1003 |
alkyl(C12-C18)(ethylbenzyl)dimethylamonium- chloridy (xxxx xxx xxxxx xxxxxxxxx xxx xxxxxxx 725) |
XX |
xxxx relevantní |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
|
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x |
x |
x |
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x |
1005 |
alkyl(C12-C14)benzyl(dimethyl)amonium-chloridy (xxxx než xxxxx xxxxxxxxx xxx položku 724) |
XX |
xxxx relevantní |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
x |
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x |
1006 |
xxxxxxxxxxxxxx xxxx xxxxxxxxxx xxxxxxx, xxxxx, hliník a xxx |
XX |
xxxx relevantní |
398477-47-9 |
|
x |
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x |
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x |
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1009 |
xxxxxxx(X8-X10)xxxxxxxxxxxxxx-xxxxxxxx (xxxx xxx xxxxx xxxxxxxxx xxx xxxxxxx 673) |
IT |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
x |
x |
|
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x |
x |
x |
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1011 |
alkyl(trimethyl)amonium-chloridy (xxxxx xxxxxxx xx xxxxxxxx xxxxxxx xxxxxxxxxx oleje) (xxxx než xxxxx xxxxxxxxx pod xxxxxxx 635) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
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x |
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1012 |
xxxxxxxxxxxxxxxxx xxxxx, stříbrný x xxxxxxxxx xxxxxxx/xxxxxxxx-xxxxxxxxx zeolit |
XX |
xxxx xxxxxxxxxx |
130328-20-0 |
|
x |
|
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x |
|
x |
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|
598 |
(±)-1-(β-xxxxxxxx-2,4-xxxxxxxxxxxxxxxxx)xxxxxxxx (xxxxxxxx technický) |
XX |
xxxxxxxxx xx xxxxxxx rostlin |
73790-28-0 |
|
|
x |
|
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|
XXXXXXX XXX
Xxxxx
Xxxx xxxxxxxxx |
Xxxxx xxx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx xx. 6 odst. 3 xxxx. x) |
Xxxxx xxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxx xx. 7 odst. 2 písm. b) |
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 a 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 |