XXXXXXXX KOMISE X XXXXXXXXX XXXXXXXXX (XX) č. 1062/2014
xx xxx 4. xxxxx 2014,
xxxxxxxx xx xxxxxxxxxx xxxxxxxx systematického xxxxxxxx všech stávajících xxxxxxxx xxxxx obsažených x xxxxxxxxxx přípravcích, xxxxx xxxx xxxxxxx x xxxxxxxx Evropského xxxxxxxxxx x Xxxx (XX) x. 528/2012
(Xxxx x xxxxxxxx xxx XXX)
XXXXXXXX XXXXXX,
x xxxxxxx xx Xxxxxxx x xxxxxxxxx Xxxxxxxx xxxx,
x ohledem xx xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (EU) x. 528/2012 xx xxx 22. xxxxxx 2012 x xxxxxxxx xxxxxxxxxx přípravků xx xxx x xxxxxx xxxxxxxxx (1), a xxxxxxx xx xx. 89 xxxx. 1 xxxxx xxxxxxxxxxx xxxxxxxxx nařízení,
xxxxxxxx x xxxxx důvodům:
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(1) |
Xxxxxxxx Xxxxxx (XX) x. 1451/2007 (2) xxxxxxx xxxxxxxxx xxxxxxxx xxx xxxxxxx přezkumu xxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx (dále xxx „xxxxxxx xxxxxxxx“), který xxx xxxxxxx v souladu x xx. 16 odst. 2 xxxxxxxx Xxxxxxxxxx parlamentu a Rady 98/8/XX (3). Xxxxxxx xxxx xxxxxxxx byla xxxxxxx x xxxxxxxxx xxxxxxxxx (XX) x. 528/2012, xxxx by xxx xxxxxxxxx xxxxxxxx xxx pokračování xxxxxxxx xxxxxxxx xxxxxxxxxxxx ustanovením xxxxxxxxx xxxxxxxx. |
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(2) |
Xx xxxxxxxx xxxxx xxxxxxxxx xxxxxx xxxxx a xxxx xxxxxxxxx, xxxxx mohou xxx xxxxxxxx xx xxx x xxxxxxxxx podle přechodných xxxxxxxxxx článku 89 nařízení (XX) x. 528/2012 x xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx. Xxxx xx xxxx xxx x x xxxxxxx xxxxxxxxx účinné látky x xxxx xxxxxxxxx, xxxxx xxxx xxxxxxxxx x xxxxxxxx xxxxxxxx. |
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(3) |
Xxxxx xxxxxxxxx xxxxxxxx odchylky xxx potraviny a krmiva xxxxx článku 6 xxxxxxxx (XX) č. 1451/2007, xxx xxxxxxxxxx se xx něj xxxxxxx xxx xxxxxxxxx a krmiva xxxxxxx v čl. 2 xxxx. 5 xxxx. x) xxxxxxxx (XX) x. 528/2012, měly by xxx účinné xxxxx, xxxxx xxxxxxxx, hodnoceny x xxxxxxxx xxxxxxxx pro xxxxxxxxx typ xxxxxxxxx. X xxxxxxxx vnitrostátních xxxxxxxx xx xxxx xxx xxxxxx xxxxxxxx xx xxx x xxxxxxxxx xxxxxxxx xx xx xxxxxxxx xxxxxxxxx xxxxxxxxx. Xxxxxx předchozího xxxxxxxxxx xx xxx xxxxxxx, xxxxx xxxxxxxxx xxxxxx xxxxxxxxxx využijí. Totéž xx xxxx platit x xxxxxxxxx, xxx xxxxxxxxxx xxxxxxxxx xxxxxx látky x xxxx přípravku xxxxxxxxx x nové xxxxxxxx xxxx xxxxxxxxx x xxxxxxxx (XX) č. 528/2012 oproti xxxxxxxx xxxxxxx xx xxxxxxxx 98/8/ES nebo xx xxxxx odůvodněno xxxxxxxxxxx Xxxxxx přijatým x xxxxxxx x xx. 3 xxxx. 3 xxxxxxxx (XX) č. 528/2012, xxxxxxxxxxx (xxxxxxxxx xxxxxxxxxxx xx věci X-420/10 (4)) xxxx xxxxxxxxx pokyny Xxxxxx xx příslušných xxxxxx xxxxxxxxx států, xxxxx xx následně xxxxxxx. |
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(4) |
Xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx účinnou látku, xxxxx xxx xxxx xxxxxxxx xx xxxxxxxx xxxxxxxx, x xxxx xxxxx sestává xxxx xx z xx xxxxxx, xxxxx xxxxxxxx xx používání xxxxxx xxxxxxxxxx xxxxxxxxx x xxxxxxxx xxxxx xxxxxxxx, xxxx xx být v tomto xxxxxxxx státě xxxxxxx x xxxxxxxx na trh xxxxxxxx na jeho xxxxxxxxxxxx, xx určitých xxxxxxxx a po omezenou xxxx. |
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(5) |
X xxxxx xxxxxxxxxxx x xxxxxxxxxxxx xx xxx xxx xxxxxx hodnocení xxxxxxxx látek x xxxxxxxx xxxxxxxx xx všech xxxxxxxxxx xxxxxxx xxxxxxx x xxxxxxxx xxxxxxxxxx xxx žádosti předložené xxxxx xxxxxx 7 xxxxxxxx (XX) č. 528/2012 xxxx xxxxx xxxxxxxxxxx xxxxxxxx Xxxxxx (EU) č. 88/2014 (5). |
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(6) |
Pro xxxxx, xxxxx xxxxxxx xxxxxxxx xxxxxxxxx xxxx xxxxxxxx xxx náhradu, xx xxx hodnotící xxxxxxxxx orgán předložit xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxxxxx a označení látky xxxxx xx. 37 odst. 1 xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 1272/2008 (6), xxxxx xxx o xxxxxxxxx xxxxxxxxxx vzbuzující xxxxx, x xxxxxxx xx xxxx xxx zachováno xxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx xxxxxxxx xx xxxxxx nebo xxxxx sledovaných vlastností. Xxxxxxxxx xxxxxxxxx orgán xx měl xxxx xxxxxxxxxxx agenturu x xxxxxxx xxxxx, xxxxx xx xxxxxxxxx xxxxxxxx xxx xxxxx xxxxxxxxxxxx, xxxxxxxxxxxxxxx či toxické, nebo xxxxx, xxxxx by xxxxx xxx xxxxxxxxxx xx látky s vlastnostmi xxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxx. |
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(7) |
Xxx xxxx xxxxxxxxx, xx xxxxxxx xxxxxxxx xxxx xxxxxxxx xx xxxxxxxx data uvedeného x xx. 89 odst. 1 xxxxxxxx (XX) x. 528/2012, mělo xx xx xxxxxxxxx xxxxxx xx xxxxxxxxx xxxxxx xxxxx x xxxx xxxxxxxxx, x nichž xxxx příslušné xxxxx xxxxxxxxxx ve lhůtách xxxxxxxxxxx x xxxxxxxx (ES) x. 1451/2007 xxxx x xxxxx xxxxxxxx. Xxxxx toho xx xx měly xxxxxxxx xxxxxx lhůty xxx xxxxxxxxx hodnocení, xxxxxxx xx se měla xxxx x xxxxx xxxxxxx, xx žádosti xx xxxxx xxx xxxxxxxxx xxxx xxx xxx před uplynutím xxxxxx xxxx. |
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(8) |
Xxxxxxx xxxxxxxx xx xxxxxxx I xxxxxxxxx 7 xxxxxxxx (XX) x. 528/2012 dosud xxxxxx xxxxxxxxx xxxxx xxxxxxxxx xx xxxxx. Xx xxxxx xxxxxx x xxxx xxxx xxxxxx xxxxxxx x xxxxxxxx xx xxxxxxx xxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6. |
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(9) |
Xxx xxxxxx xx xx. 90 xxxx. 2 xxxxxxxx (EU) x. 528/2012 xxxxxxx x xxxxxx 91 xxxxxxxxx xxxxxxxx, xx xxxxxxxx uvedená x xxxxxx 10 xxxxxxxxx nařízení by xxxx být relevantní xxx xxxxxxxx povolování xxxxxxxxxx xxxxxxxxx xx xxxxx xxxxxxxxx. Je proto xxxxxx xxxxx xxxxx xxxxxxxxx tato xxxxxxxx xx xxxxx xxxxxxxxxxx xxxxxxxx xxxxx. |
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(10) |
Xxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xx měl xxx možnost se xx xxxxxxxx xxxxxx xxxxxxxx ke xxxxxxxxxxx xxxxxxxxxxx xxxx xxx xxxxxxxx za předpokladu, xx xxxxx xxxx xxxxxxx ke xxxxxxxx xxxxxxxxx x xxxxxx xxxxxxxxx xxxxxxxx k údajům, xxxxxxx jinak xx xxxxxxxxxxx účastník xxxxx xxxxxxxxx xxxxx znovu. |
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(11) |
Protože xx účast x xxxxxxxx xxxxxxxx xxxxxxxxxx, xxxx xx xxx xxxxxxxxxx xxxxxxxx od ní xxxxxxxxx. Xxxxx x xxxx dojde, xxxx xx xxx xxxxxxxxxxx xxxxxxxxx xxxxxxx xxxxxxx xxxxxxx, nebylo-li xxxx xxxxxxxx využito již xxxxxx, neboť tím xxxxxxx ke xxxxxxxx xxxxxxxx xxxxxxxx, x xxxxxxxx-xx agentura xxx xxxxxxxx na xxxx xxxxxxxxxx. |
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(12) |
Xxxxx xx xxx xxxxxxxxx xxxxxx xxxxx xxxxx, xx xxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxxxxx neodpovídá xxxxxxxx xxxxxxxx xxxxxxxxx xxxxx, x x xxxxxxxxx xxxxx xxxxxxx xxxxxx xxxxxxx xxxxxxxx xxxxxxxxx zařazené xxxxx, mělo xx xxx xxxxx tuto xxxxx v průběhu hodnocení xxxxx definovat x xxxxxxx xxxxx osobám, aby xxxxxxxx xxxxxxx xxxx xxxxxxxxx xxxxxxxx látky. |
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(13) |
Xxxxxxx xxxxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxxxxx x době xxxxxxx xxxxxx nařízení xxxxxxxxxxx xxxxxx účastníkem. Xxxxx xx xxxx určitých xxxxxxxxxxxxx, ačkoli xxxxx xx. 4 xxxx. 4 xxxxxxxx (XX) x. 528/2012 tyto xxxxxxxxx xxxxx schválit, xxxxx tak xxxx xxxxxxxx stanoveno. U xxxxxxxxx xxxxx a xxxxxxxxxxxxx by měly xxx xxxxx xxxxxxx xxxxxxx účast, xxxxxxx xxxxx xx tyto xxxxx x xxxxxxxxxxxxx xxxxxx xxx x programu xxxxxxxx xxxxxxxxx. |
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(14) |
Xxx xxxx xxxxxxxxx, xx xxxxx xxxxx xxxxxxxxx x xxxxxxxx xxxxxxxxxxx ani xx xxx nebude xxxxxxxx, aniž by xxxxxxxx xxxx vyhodnocena, xxxx by xxxxxxxx xxxxx, xxxxx xxxxx xxxxxx xxxxxxxxx, x xxxxxxxx xxxx xxxx xxxxxxxx podléhat xxxxxxxxxx xxxxxxxxxx xxxxx x xx, |
XXXXXXX TOTO XXXXXXXX:
XXXXXXXX 1
XXXXXXX X XXXXXXXX
Xxxxxx 1
Xxxxxxx
Xxxx xxxxxxxx xxxxxxx pravidla xxx xxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx všech xxxxxxxxxxx xxxxxxxx látek xxxxxxxxx v článku 89 xxxxxxxx (XX) č. 528/2012.
Xxxxxx 2
Xxxxxxxx
Xxx xxxxx xxxxxx xxxxxxxx xx xxxxxxx tyto xxxxxxxx:
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„rozhodnutím x neschválení“ xx xxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx látky x xxxx xxxxxxxxx xxxxx xx. 9 xxxx. 1 xxxx. x) xxxxxxxx (XX) č. 528/2012 nebo xx. 89 xxxx. 1 xxxxxxx xxxxxxxxxxx xxxxxxxxx nařízení, xxxx xxxxxxxxx xxxxxxxxx xx xxxxxxx I nebo XX xxxxxxxx 98/8/ES; |
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„kombinací xxxxx x xxxx přípravku xxxxxxxxx xx xxxxxxxx xxxxxxxx“ se xxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxx x xxxxxxx XX, která xxxxxxx xxxx podmínky:
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„xxxxxxxxxx“ se xxxxxx xxxxx, xxxxx xxxxxxxxxx žádost x xxxxxxxxx látky x xxxx xxxxxxxxx xxxxxxxx do programu xxxxxxxx xxxx předložila xxxxxxxx, xxxxx xxxxxxxx xxxxxxxxxx xxxxx xx. 17 xxxx. 5 xxxxxx nařízení, xxxx xxxxxx jménem xxxx xxxx xxxxxx xxxx xxxxxxxx xxxxxxxxxx; |
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„xxxxxxxxxx xxxxxxxxxx orgánem“ xx xxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx xxxxxxxxx x příloze XX xxxxxx nařízení, xxxxxx x xxxxxxx x xxxxxxx 81 nařízení (XX) x. 528/2012. |
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XXXXXX XXXXXXXXX XXXXXXXXXXX
Xxxxxx 3
Žádost o xxxxxxxxx xxxx xxxxxxxx xx xxxxxxx I xxxxxxxx (XX) x. 528/2012
1.&xxxx;&xxxx;&xxxx;Xxxxxx x&xxxx;xxxxxxxxx či xxxxxxxx do přílohy X&xxxx;xxxxxxxx (XX) x.&xxxx;528/2012 xxxx xxxxx xxxxx xxxxxxxx, x xxxxx xxxxxxxx xxxxx xxxxxxxx x xxxxxx, xx odpovídá xxxxxxxxxx xxxxx xx.&xxxx;17 xxxx.&xxxx;5 xxxxxx xxxxxxxx.
Xxxxx xx xxxxxx týká xxxxxxxx xx&xxxx;xxxxxxx I nařízení (XX) x.&xxxx;528/2012, xxxx 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 xx&xxxx;xxxx xxx xx xxxxxxxxxx x&xxxx;xxxxxxx x xxxxxxxxx xxxxx xx.&xxxx;17 odst. 5.
Xxxxxx 4
Přijetí xxxxxxx
1. Xxxxxxxx xxxxxxxxx účastníka o xxxxxxxx xxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx Xxxxxx (XX) č. 564/2013 (7) x zamítne xxxxxx, xxxxx xxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxx 30 xxx. X xxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx i xxxxxxxxx xxxxxxxxx xxxxx.
2. Xx obdržení xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxxx (XX) x. 564/2013 xxxxxx xxxxxxxx žádost x xxxxxxxxx x xxx účastníka x xxxxxxxxx xxxxxxxxx orgán, xxxxxxx xxxxx xxxxx xxxxxxx žádosti x xxxx xxxxxxxxx xxxxxxxxxxxxx xxx.
3. Xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 1 xxxxxx xxxxxx xxx xxxxx xxxxxxx prostředek x xxxxxxx s xxxxxxx 77 xxxxxxxx (EU) x. 528/2012.
4. Xxxxxxxxx xxxxxxxxx xxxxx informuje xxxxxxxxx x xxxxxxxx xxxxxxxx xxxxx čl. 80 xxxx. 2 xxxxxxxx (XX) x. 528/2012 xx 30 xxx xxxx, xx xxxxxxxx xxxxxxx žádost, x xxxxxxx xxxxxx, pokud xxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxx 30 xxx. X xxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x agenturu.
Xxxxxx 5
Xxxxxxxxx xxxxxxx x schválení xxxx xxxxxxxx xx xxxxxxxxx 6 přílohy X xxxxxxxx (EU) x. 528/2012
1. Xxxxx agentura 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 x xxxxxxx x xx. 6 xxxx. 1 x 2 xxxxxxxxx xxxxxxxx, x xxx xxxxxxxx poplatek xxxxx xx. 4 xxxx. 4, xxxxxxxxx xxxxxxxxx xxxxx xxxxxx xxxxxxx xx 30 dnů xx xxxxxxxxx xxxxxxxx.
2. Xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxx od účastníka xxxxxxxxxxx xxxxx xxxxxxxx (XX) x. 1451/2007, xxxxx ta xxxxx nebyla xxxxxx xxxx xxxxx podle xxxxxx 13 xxxxxxxxx xxxxxxxx, xxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxx xxxxxxxxxx xx 3. xxxxx 2015.
3. X xxxxxxxxx xxxxxxxxx x odstavcích 1 x 2 hodnotící xxxxxxxxx orgán neprovádí xxxxxxxxx xxxxxxx xxx xxxxxxxxxxxx xxxxxxxxxxxx údajů xxxx xxxxxxxxxx.
4. Xxxxx xxxxxxxxx xxxxxxxxx orgán usoudí, xx xxxxxx xx xxxxxxx, xxxxx účastníkovi, xxxx doplňující informace xxxx k xxxxxxxxx xxxxxxx xxxxx, x x xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx. Xxxx xxxxx xxxxx xxxxxxxxxx 90 dnů.
Rozhodne-li xxxxxxxxx xxxxxxxxx orgán, xx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx postačují xx xxxxxxx požadavků uvedených x xxxxxxxx 2, xxxxxxx xxxxxx xx 30 dnů od xxxxxxxx xxxxxxxxxxxx xxxxxxxxx.
Xxxxxxxx xxxxxxxx xxxxxxxxxx informace xx xxxxxxxxx xxxxx xxxxxxxxxx, hodnotící příslušný xxxxx xxxxxx zamítne x xxxxxxxxx o xxxx xxxxxxxxxxx xxxxxxxxx x xxxxxxxx. X xxxxxx případech xx xxxxx poplatky zaplacené x xxxxxxx s čl. 80 odst. 1 x 2 xxxxxxxx (XX) x. 528/2012.
Xxx xxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxxx orgán xxxxxxxxxx informuje xxxxxxxxx, xxxxxxxx x xxxxx xxxxxxxxx xxxxxx x xxxxx xxxxx xxxxxx xxxxxxxxx.
Xxxxxx 6
Hodnocení xxxxxxx
1. Tento xxxxxx xx použije, xxxxx xxxxx xxxxxxx x xxxxxx xxxxxxxx:
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x) |
xx-xx xxxxxx xxxxxxxxx xxxxx xxxxxx 5; |
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xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxx dokumentaci xxxx xxxxxx podle xxxxxx 13 xxxxxxxx (ES) x. 1451/2007, ale xxxxx xxxxxxxxxxx Komisi xxxxxx xxxxxxxxxxx xxxxxx xxxxx xx. 14 xxxx. 4 uvedeného xxxxxxxx; |
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xxxxx xxxxxxxx xxxxxxx xxxxxx x xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4 xxxx 5 přílohy I nařízení (XX) x. 528/2012 podle xx. 4 odst. 2 a xxx xxxxxxxx xxxxxxxx xxxxx xx. 4 odst. 4. |
2. Hodnotící xxxxxxxxx orgán xxxxxxxx xxxxxx xxxxx xxxxxx 4 a 5 xxxxxxxx (EU) x. 528/2012 x xxxxxxxx xxx veškeré návrhy xx úpravu xxxxxxxxx xx údaje předložené x xxxxxxx x xx. 6 xxxx. 3 xxxxxxxxx nařízení x xxxxx hodnotící xxxxxx x závěry xxxxx xxxxxxxxx xxxxxxxx.
3. Pokud xxxxxxx kombinaci xxxxx x xxxx xxxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxx, xxxxxxxxx xxxxxxxxx příslušný xxxxx xxxxx xxxxx xxxxxxxxx xxxxxx. Xxxxxxxxx xxxxxx x xxxxxx xxxxx x xxxxx x xxxxxx xxxx, xxxxx toho, xx xxxxxxx xxxxxxx:
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365 xxx xx posledním xxxxxxxxx uvedeném x xxxx. 1 xxxx. x), xxxxxx xxxxxxxx xxxxxxxx x xxxx. 1 xxxx. x) xxxx xxxxxxxxx xxxxxxxx xxxxxxxxx x xxxx. 1 xxxx. x) x xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx; |
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b) |
ve xxxxx xxxxxxxxx x xxxxxxx XXX. |
4. Xxxx xxx, xxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxxxx xxx xxxxxx xxxxxxxx, xxxxxx xxxxxxxxxxx xxxxx do 30 xxx x xxxxxxxxx xxxxxx x x xxxxxxx hodnocení xxxxxxx xxxxxxxxxx. Xxxxxxxxx xxxxxxxxx xxxxx tyto xxxxxxxxxx xxxxxxxxxxxxx způsobem xxxxxxxx x závěrečné xxxx xxxxx xxxxxxxxx.
5. Xxxxx xx xxxxx, xx xxxx x xxxxxxxxx xxxxx xxxxxxxxxx xxxxxxxxx, hodnotící xxxxxxxxx orgán účastníka xxxxx, xxx xxxx xxxxxxxxx ve xxxxxxxxx xxxxx xxxxxxxxx, a xxxxxxxxx x tom xxxxxxxx.
Xxxxx 365 dnů xxxxxxx x xxxxxxxx 3 xx xxxxxxx xx xxxx ode xxx xxxxxxxx xxxxxxxxx xx dne xxxxxxxx xxxxxxxxx. Xxxxx xx xxxx xxxxxxxxxx xxxxxxx xxxxxxxxxxxx xxxxx xxxx xxxxxxxxxxx okolnostmi, přerušení xxxxxxxxxx xxxxxxxxxxx xxxxx:
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a) |
365 xxx x xxxxxxx, xx xx doplňující xxxxxxxxx xxxxxx xxxxxx, xxxxx xxxxxx xxxxxx x xxxxx xxxxxxxx 98/8/ES xxxx x xxxxx xxxxxxx xxxxxxxxxxx xxx uplatňování xxxxxxx směrnice; |
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180 xxx xx xxxxx xxxxxxxxx případech. |
6. Xxxxx xxxxxxxxx xxxxxxxxx xxxxx xxxxxx, xx xxxxxxxx xxxxx xxxxxxx zdraví xxxx xxxx zvířat xxxx xxxxxxxxx prostředí xxxxxxxxxxx x xxxxxxxxxxxxx účinků xxxxxxxxxx x xxxxxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxxxxx stejné xxxx xxxxxxxx xxxxxx xxxxx, xxx obavy zdokumentuje x xxxxxxx s požadavky příslušných xxxxx xxxxxx XX xxxx 3 přílohy XX xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x Xxxx (XX) x. 1907/2006 (8) a zahrne xx xx xxxxx xxxxxx.
7. X xxxxxxx xxxxxxx xx dokončení xxxxxxxxx xxxxxxxxxxxxx hodnotící xxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxx a nejpozději při xxxxxxxxxx hodnotící xxxxxx xxxxx xxxxxxxx 3:
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x) |
xxxxxxxx xxxxx xxxxxxxx podle xx. 37 xxxx. 1 xxxxxxxx (XX) x. 1272/2008, jestliže xx xxxxxxx, xx xx xxxxxxx jedno x xxxxxxxx xxxxxxxxx x xx. 36 xxxx. 1 xxxxxxxxx xxxxxxxx, xxx xxxx xxxxxxxx xxxxxx x xxxxx 3 přílohy VI xxxxxxxxx nařízení; |
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b) |
konzultuje s agenturou, xxxxx se domnívá, xx xxxxx z kritérií xx. 5 xxxx. 1 písm. d) xxxx x) xxxxxxxx (XX) x. 528/2012 xxxx xxxxxxxx xx. 10 xxxx. 1 písm. d) xxxxxxxxx xxxxxxxx xxxx xxxxxxx, ale xxxxxx xxxxxxxx xxxxxx v příloze XXX xxxxxxxx (ES) x. 1907/2006 nebo x xxxxxxx xxxxxxxx x xx. 59 xxxx. 1 xxxxxxxxx nařízení. |
Xxxxxx 7
Stanovisko agentury
1. Tento xxxxxx se použije, xxxxx xxxxx xxxxxxx x xxxxxx podmínek:
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x) |
xxxxx hodnotící xxxxxxxxx xxxxx předložil xxxxxxxxx xxxxxx xxxxx xx. 6 xxxx. 2 x xxxxxxxx xxxxxxxxx xxxxx xxxx xxxxxxx konzultaci xxxxx xx. 6 xxxx. 7; |
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xxxxx xxxx předložena Xxxxxx xxxxxx xxxxxxxxxxx xxxxxx xxxxx xx. 14 odst. 4 xxxxxxxx (XX) č. 1451/2007, xxx xxxxxxxxx zprávu xxxxx xxxxxxxxxxxx Stálý xxxxx pro xxxxxxxx xxxxxxxxx podle čl. 15 xxxx. 4 uvedeného xxxxxxxx. |
2. Xx xxxxxxx xxxxxx agentura xxxxxxxxx a předloží Komisi xxxxxxxxxx x xxxxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxx jeho xxxxxxxx xx xxxxxxxxx 1, 2, 3, 4, 5 xxxx 6 xxxxxxx X xxxxxxxx (XX) x. 528/2012, xxxxxxxx xxxxxx, x xxxxxxx xx xxxxxx xxxxxxxxxxx xxxxxxxxxxx xxxxxx.
Xxxxxxxx zahájí xxxxxxxx xxxxxxxxxx x xxxxx x xxxxxx xxxx, xxxxx xxxx, xx xxxxxxx xxxxxxx:
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x) |
xx xxx xxxxxx po xxxxxxx xxxxxx; |
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x) |
ve xxxxx xxxxxxxxx x xxxxxxx XXX. |
Agentura xxxxxxxx xxxxxxxxxx Xxxxxx xx 270 xxx xx xxxxxxxx xxxxxxxx.
Xxxxxx 8
Xxxxxx xxxxx, xxxxx xx xxxx xxxxxxxx
1. Xxx xxxxxxxx xxxxx xxxxxxxxxx xxxxx čl. 7 xxxx. 2 xxxxxxxx xxxxxxx, xxx účinná látka xxxxxxx některé z kritérií xxxxxxxxx x xx. 10 xxxx. 1 xxxxxxxx (XX) x. 528/2012, x xxxx xxxxxx xxxxx xx xxxx xxxxxxxxxx.
2. Xxxx xxxx xxxxxxx xxxxxx 66 x 67 xxxxxxxx (XX) x. 528/2012, xxxxx xxx xxxxxxxx xxxxxxxx xxx xxxxxxxxxx Xxxxxx, xxxxxxxx xxxxxxxxx x xxxxxxx xxxxxxx, xxxxx se mají xxxxxxxx, xxxxx maximálně 60 xxx; x xxxx xxxx xxxxx xxxxxxxxxx xxxxx xxxxxx xxxxxxxxx příslušné xxxxxxxxx xxxxxx xxxxxxxxx o dostupných xxxxxxxxx. Xxxxxxxx obdržené xxxxxxxxx xxxxxxxx xxxxxxxx x závěrečné xxxx xxxxxxxx xxxxx xxxxxxxxxx.
3. Xxxxx xx xxxxxx xxxxx xxxxxxxxx a splňuje xxxxx x xxxxxxxx xxxxxxxxxxx x xx. 10 xxxx. 1 xxxxxxxx (EU) x. 528/2012, xxxx xxx xxxxxxxx xx xxxxx, xxxxx xx má xxxxxxxx, v nařízení xxxxxxxx x xxxxxxx x xx. 89 odst. 1 xxxxxx xxxxxxxxxxxx xxxxxxxxx xxxxxxxx.
Xxxxxx 9
Xxxxxxxxxx Komise
Po xxxxxxxx xxxxxxxxxx xxxxxxxx xxxxx čl. 7 odst. 2 Xxxxxx xxx xxxxxxxxxx xxxxxxxx xxxxxxxx návrh xxxxxxxxxx xxx přijetí xxxxx xx. 89 xxxx. 1, xxxx xxxxxxxx xxxxx xx. 28 xxxx. 1 xxxxxxxx (XX) x. 528/2012.
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ZMĚNY XXXXX XXXXXXXX PŘEZKUMU
Článek 10
Xxxxxxxxx xxxx nahrazení účastníků xx vzájemné xxxxxx
1.&xxxx;&xxxx;&xxxx;Xxxx xxxxxxxxx xx možno xx xxxxxxxx xxxxxx xxxx stávajícím xxxxxxxxxx x potenciálním účastníkem xxxxxxx xxxx sdílet xx xxxxxxxxxxx, že xx xxxxxxxxxxx účastník xxxxx xxxxxxxxx xx xx xxxxxxx xxxxx xxxxxxxxxx nebo xxxxxxx xxxxxxxxxx účastníkem.
2. Oznámení xxx xxxxx xxxxxx xxxxxx xxxxxxxxxxx agentuře xxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxxxx účastník xxxxxxxxxxxxxxx xxxxxxxxx xxx xxxxxxxx xxxxxxxxx uvedeného x xxxxxx 71 xxxxxxxx (XX) x. 528/2012 (xxxx jen „xxxxxxxx“) x&xxxx;xxxxxxxx xxxx xxxxxxxxx všechna xxxxxxxxx xxxxxxxx k xxxxxxxx.
3.&xxxx;&xxxx;&xxxx;Xx xxxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxx odstavce 2 xxxxxxxx aktualizuje xxxxxxxxx x&xxxx;xxxxxxxxx xxxxxxxx xx xxxxxxxxxx xxxxxxxxx.
4.&xxxx;&xxxx;&xxxx;Xxxxx xxxxxxx xx&xxxx;xxxxx Xxxx, xxxxx xxxxxxxx roli xxxxxxxxx xxxx xx xxxxxxxxx k xxxxxxxxxxx xxxxx xxxxxx článku, xx xxx účely xxxxxx 95 xxxxxxxx (XX) č. 528/2012 xxxxxxxxxx xx xxxxx, která xxxxxxxxxx dokumentaci xxxx xxxxxxxx x přístupu x dokumentaci.
Xxxxxx 11
Xxxxxxxxxx xxxxxxxxx
1. Xx xx xx to, xx xxxxxxxx xxxxxxxxx x účasti xx xxxxxxx kombinace xxxxx x xxxx xxxxxxxxx x xxxxxxxx xxxxxxxx, x těchto xxxxxxxxx:
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xxxxx xxxxxxxxxx xxxxxxxx xxxx hodnotící xxxxxxxxx xxxxx xxxxxxxxxxxxxxx xxxxxxxxx x xxxx xxxxxx xxxxxxxxx; |
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xxxxx xxxxxxxxxxx xxxxxx xx lhůtě xxxxxxx x xx. 3 odst. 2; |
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pokud xxxx xxxxxx byla xxxxxxxxx xxxxx xx. 4 xxxx. 1, xx. 4 odst. 4 nebo xx. 5 odst. 4; |
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xxxxx xxxxxxxxxxx xxxxxxxxxx informace xx xxxxxxx uvedených x xx. 6 xxxx. 5; |
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xxxxx jinak xxxxxxxxxx xxxxxxxx hodnotícímu příslušnému xxxxxx xxxx xxxxxxxx. |
2. Xxxxxxxxxx xx xxxxxxxx xx xxxxxxxxx včas, pokud x xxxx nedojde xx xxxx, xxx xxxxxxxxx xxxxxxxxx orgán xxxxxxxxx xxxxxxxx xxxxxx xxxxxxxxxxx xxxxxx xxxxx xx. 6 xxxx. 4 xxxxxx xxxxxxxx.
Xxxxxx 12
Xxxxxxxx xxxxxxxx xxxxxxxxxx
1. Xxxxx xx o xxxxxxx odstoupení xxxxxxxxxx xxxxxxxxx xxxxxxxxx orgán, xxx xxxxxx xxxxxxxx, xxxxxxxxx ji hodnotící xxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx.
2. Xxxxx xx x xxxxxxx xxxxxxxxxx informována xxxxxxxx, xxxxxxxxxxx xxxxxxxxx x xxxxxxxxx týkající se xxxxxxxxxx xxxxxxxxx.
3. Xxxxx x xxxxxxxx xxxxxxxx xxxx xxxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx tutéž kombinaci xxxxx x xxxx xxxxxxxxx x xxxxx byla role xxxxxxxxx xxx xxxxxxxx xxxxxxxxx xxxxx převzata, xxxxxxxxx o tom xxxxxxxx xxxxxxxxxxxxxxx rejstříku Xxxxxx.
Xxxxxx 13
Xxxx xxxxxxxx xxxxxxxxx xxxxx
1. Xxxxx xxxxxxxxx xxxxxxxxx xxxxxx xxxxx xxxxxxxx xxxxxxx xxxxxx xxxxxxxx se xxxxx, xxx xxxx xxxxxxx x xxxxxxx XX, hodnotící xxxxxxxxx xxxxx xx xxxxxxxxxx x dotyčným xxxxxxxxxx xxxxxxx xxxxx xxxxxxxx xxxxx. Xxxxxxxxx xxxxxxxxx xxxxx o tom informuje xxxxxxxx.
2. Xxxxxxxx x xxxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx xx xxxxxxxx xxxxx.
Xxxxxx 14
Převzetí xxxx xxxxxxxxx
1. Xxxxxxxx xxxxxxxx otevřenou xxxxx x xxxxxxxx xxxx xxxxxxxxx pro xxxxxxxxx xxxxx x xxxx xxxxxxxxx, pokud xxxxxxx xxxxx x xxxxxx xxxxxxx:
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xxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxx xxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx včas xxxxxxxxxx xxxxx xxxxxx 11 x xxxxxx role účastníka xxx xxxxx xxxxxxxxx xxxxxx předtím xxxxxxxx; |
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na základě xxxx definice xxxxx xxxxxx 13; x xxxxx případě xx xxxxx týká xxxxx xx xxxxx, xx xxxxxx xx vztahuje xxxxxxxxx xxxxxxxx x xxxxxxx XX, xxx xxxxxxx nová xxxxxxxx látky. |
2. Xx xxxxxxxx xxxxxx xxx xxx xxxxxxxxxx xxxxx xxxxxxxx 1 xxxx kterákoli osoba xxxxxxxxx oznámení xxx xxxxxxxxx xxxxx článku 17.
3. Xx xxxxxxxx měsíců xx xxxx xxxxxx xxxxxx xxxxxxxx x xxxxxxxx může kterákoli xxxxx oznámit xxxxxxxxx xxxxx a typu přípravku xxxxxxxxx do části 2 xxxxxxx XX podle xxxxxx 17.
Xxxxxx 15
Kombinace xxxxx x typu xxxxxxxxx xxxxxxxxx pro zařazení xx programu přezkumu
Xxxxx xxxxxxxx xxxxxxxxx, xxxxx xxxxx xx oblasti xxxxxxxxxx xxxxxxxx (XX) x. 528/2012 x xx xxxxxx na trh, xxxxxxx xx xxxxxxxxx xxxxxx látky, xxx xxxx xxxxxxxxx ani xxxxxxxx do xxxxxxxx xxxxxxxx pro xxxxx xxx přípravku x xxxx xxxxxxxx xx xxxxxxx I xxxxxxxxx xxxxxxxx, xxxx xxxxx xxxxxxxx xxxx xx x ní xxxxxx, xx uvedená xxxxx xxxxxxxxx xxx xxxxxxxx xx xxxxxxxx xxxxxxxx xxx xxxxxxxxx typ přípravku xx xxxxxxx xxxxxxxxx z těchto xxxxxx:
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x) |
xxxxx xxxxxxxxx výrobek xx xxx xx xxxxxxxxx xx xxxxxx nebo xxxxxxx doporučení vydané Xxxxxx xxxx příslušným xxxxxxx xxxxxxxxxx x xxxxxxx x xxxxxxx 26 směrnice 98/8/XX xxxx xxxxxxx 81 xxxxxxxx (XX) x. 528/2012, xxxxx xx xxxxxxx xxxxxxxxxx xxxxxxxxxxxxxx důvodů xxxxx xxxxxxx xxxxxx xx xxxxxxxxxx x xxxxxxxxxxx, že výrobek xxx xxxxx z působnosti xxxxxxxx 98/8/XX nebo xxxxxxxx (XX) č. 528/2012, xxxx xx byl xxxxxxxxx xxx xxxxxxxxx xxxxxx x xxxxxxxxx, xxx xxxxx byla účinná xxxxx oznámena, x xxxxx xxxx xxxxxxx xxxxxx xx xxxxxxxxxx xxxxxxxx xxxxxxxxxxx x xxxxxxxxxx xxxxxxxx podle xx. 3 odst. 3 xxxxxxxx (XX) č. 528/2012 xxxx x xxxxxx, závazných xxxxxxxx zveřejněných Xxxxxx; |
|
x) |
látka xxxxxxxxx odchylky pro xxxxxxxxx x xxxxxx xxxxxxxxx x xxxxxx 6 xxxxxxxx (XX) x. 1451/2007; |
|
x) |
xxxxxxxx přípravek xxxxx xxxxx xxxxxxxx (XX) x. 528/2012 x xxxxxxxxx xxxx přípravku, xxx tomu bylo xxxxx xxxxxxxx 98/8/XX, x xxxxxxxx xxxxx xxxxxxxxxx xxxxxx xxxx přípravků a obsahuje xxxxx xxxxxxxxx xx xxxxxxxx xxxxxxxx xxx xxxxxxx xxx xxxxxxxxx, ale xxxxxx xxx xxxx. |
Xxxxxx 16
Prohlášení o xxxxx xx oznámení
1. Xxxxxxxxxx x xxxxx xxxxxxx xxxxx, xxxxx xx způsobilá xxx xxxxxxxx do programu xxxxxxxx podle článku 15, xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx kterákoli xxxxx, xxx xx xxxxx xxxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx, xxxxxxx x následujících xxxxxxxx:
|
x) |
Xxxxxx xxxxxxxxxx xxxxxxx xxxxxx xx xxxxxxxxxx rozhodnutí xxxx xxxxxx xxxxxxxxx x xx. 15 xxxx. x); |
|
x) |
xxxxxxxx nejpozději 30. xxxxx 2015 x případech uvedených x xx. 15 xxxx. x); |
|
c) |
Komisi xxxxxxxxxx 30. xxxxx 2015 v případech xxxxxxxxx x xx. 15 xxxx. x). |
2. Xxxxxxxxxx xxxx obsahovat xxxxxxxxxx xxxxxxxxx látky x xxxx přípravku. V případech xxxxxxxxx x xx. 15 xxxx. x) xxxx xxxxxxxxxx xxxxxxxxx opodstatněné odůvodnění, x xxxx vyplývá, xx jsou xxxxxxx xxxxxxx xxxxxxxx v xxx xxxxxxx.
3. Xxxxx bylo xxxxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 xxxx. x) xxxx x) x Xxxxxx xxxxxxx xx xxxxxxxxxx s členskými xxxxx x xxxxxx, xx xxxxxxxx 6 není xxxxxxxxxx, a případně, xx xxxx xxxxxxx podmínky xxx xxxxxxxx xxxxxxx x xx. 15 písm. x), xxxxxxx x xxx xxxxxxxx.
4. Xxxxx xxxx xxxxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 xxxx. x) xxxx xxxxx Xxxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 3, zveřejní xxxxxxxx xxxx informaci xxxxxxxxxxxxxx xxxxxxxxxx s uvedením xxxxxxxxx xxxxxxxxx xxxxx a typu xxxxxxxxx. Xxx xxxxx xxxxxx xxxxxxxx se xxxxxxxxxx podle xx. 3x xxxx. 3 xxxxxxx pododstavce xxxxxxxx (ES) x. 1451/2007 xxxxxxxx xx xxxxxxxxxx xxxxx xxxxxx odstavce.
5. Kterákoli xxxxx, která má xxxxx xxxxxxx kombinaci xxxxx a xxxx xxxxxxxxx, xxx xxxx xxxxxx xxxxx xxxxxx 17 xx xxxxx xxxxxx xxx dne xxxxxxxxxx xxxxx odstavce 4.
6. V případech xxxxxxxxx x čl. 15 písm. x) x x) xx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxx xx xxxxxxxxx účastníkem a není xxxxxxxxx k xxxxxxx xxxxxxxx, xxxxx jsou xxxxxxx xxxx podmínky:
|
x) |
xxxxxxxxx xxxxxx látka xx xxx xxxxxxxx do programu xxxxxxxx; |
|
x) |
xxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxx xxxxx xxx xxxxxxxx xxxxxxx xxxxx, xxxxx xxxx xxxxxxxx pro xxxxxxxxx xxxx přípravku; |
|
x) |
xxxxxxxx, který xxxxxxxxx xxxxxxxx xxxxxxxxxxx, xxxxx, xx xx xxxxx x podporu xxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx. |
Xxxxxx 17
Xxxxxx xxxxxxxx
1. Oznámení xxxxx xx. 14 xxxx. 2 x 3 xxxx xx. 16 xxxx. 5 xx xxxxxxxxxxx xxxxxxxx prostřednictvím xxxxxxxxx.
2. Xxxxxxxx musí být xxxxxxxxxx xx formátu XXXXXX. Xxxx obsahovat xxxxx uvedené x xxxxxxx I.
3. Xxxxx xxxx x xxxxxxx XX xxx xxxxxxxx xxxxxxx látku uveden xxxxxxxxx příslušný xxxxx, xxxxxxxxx xxxxxxxxxxx agenturu x xxxxx jím vybraného xxxxxxxxxxx xxxxxx, xxxxx xx xxxxxxxx x xxxxxxx x xxxxxxx 81 nařízení (XX) x. 528/2012, x xxxxxxxx písemné xxxxxxxxx xxxxxxxxxxx, xx xxxxxxxxx xxxxx xxxxxxxx x xxx, xx xxxxxxxxxxx xxxxxxx.
4. Xx xxxxxxxx xxxxxxxx x xxx xxxxxxx xxxxxxxx Xxxxxx x xxxxxxxxxxxx xxxxxxxxx o poplatcích xxxxxxxxx xxxxx nařízení (XX) x. 564/2013. Jestliže xxxxxxxxxxx xxxxxxxx poplatky xx 30 xxx xx xxxxxxx xxxxxxx xxxxxxxxx, xxxxxxxx xxxxxxxx xxxxxxx x uvědomí x tom oznamovatele x Xxxxxx.
5. Xx xxxxxxxx xxxxxxxx xxxxxxxx xx 30 xxx ověří, xxx oznámení xxxxxxxx xxxxxxxxxx xxxxxxxx v xxxxxxxx 2. Pokud xxxxxxxx xxxxx xxxxxxxxxx xxxxxxxxxx, xxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxx x xxxxx 30 dnů, xxx své xxxxxxxx xxxxxxx nebo xxxxxxx. Xx xxxxxxxx xxxx 30xxxxx lhůty agentura xx 30 xxx xxx prohlásí, xx xxxxxxxx vyhovuje požadavkům xxxxxxxx 2, xxxx xxxxxxxx xxxxxxx, x xxx xxxxxxxxxx sdělí xxxxxxxxxxxx x Komisi.
6. X xxxxxxx s článkem 77 xxxxxxxx (EU) x. 528/2012 xxxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx 4 xxxx 5 podat xxxxxxx xxxxxxxxxx.
7. Xxxxx oznámení xxxxxxxx xxxxxxxxxx podle odstavce 5:
|
a) |
x xxxxxxx, xx xxxx xxxxxxxx xxxxxxxxxx podle xx. 14 xxxx. 2 nebo 3, xxxxxxxx xxxxxxxxxx xxxxxxxxxxx informace v xxxxxxxxx xxxxxxxx xx xxxxxxxxxx účastníka a xxxxxxxx identity xxxxx; |
|
x) |
x xxxxxxx, xx xxxxxxxx xxxx xxxxxxxxxx podle xx. 16 xxxx. 5, xxxxxxxx neprodleně xxxxxxxxx Komisi, že xxxxxxxxxx bylo xxxxxxxx. |
Xxxxxx 18
Zařazení xx xxxxxxxx xxxxxxxx
Xxxxx xx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxxxxx za xxxxxxxxx v souladu x xx. 16 xxxx. 6 nebo xxxxx xxxxxxxx xxxxxxxxx Xxxxxx x xxxxxxxx xxxxxxxxx x xxxxxxx x xx. 17 xxxx. 7 písm. b), xxxxxx Xxxxxx xxxxxxxxx xxxxx x xxxx xxxxxxxxx xx xxxxxxxx xxxxxxxx.
Xxxxxx 19
Xxxxxxxxx o xxxxxxx, xxxxx xxxxxx xxxxxx podporovány x xxxxx programu xxxxxxxx
Pokud xxxxxx ve lhůtě stanovené x xx. 16 xxxx. 5 obdrženo xxxxx xxxxxxxx xxxx xxxxx byla xxxxxxxx xxxxxxx xx zmíněném xxxxxx xxxxxxx x xxxxxxxx xxxxxxxxx xxxxxxxxx xxxxx xx. 17 odst. 4 xxxx 5, agentura x xxx xxxxxxxxx xxxxxxx státy xxxxxxxxxxxxxxx xxxxxxxxx a zveřejní xxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx.
Xxxxxx 20
Rozhodnutí Xxxxxx x xxxxxxx, xxxxx xxxxxx xxxxxx podporovány x xxxxx xxxxxxxx xxxxxxxx
Xxxxxx xxxxxxxx xxxxx xxxxxxxxxx o neschválení xxxxx xx. 89 xxxx. 1 xxxxxxx xxxxxxxxxxx nařízení (XX) č. 528/2012 x xxxxxx xxxxxxxxx:
|
x) |
xxxxx xxxxxxxx xxxxxxxxx Xxxxxx x xxxxxxx xxxxxxxxxx xxxxxxxxx podle čl. 12 xxxx. 3 xxxxxx nařízení; |
|
x) |
pokud xxxxx xxxxx xxxxxxxx xxxxxxxx ve lhůtách xxxxxxxxxxx x xx. 14 odst. 2 xxxx 3 xxxxxx xxxxxxxx xxxx xxxxx xxxx xxxxxxxx xxxxxxxxxx x xxxxxxxxx xxxxx xx. 17 xxxx. 4 xxxx 5; |
|
x) |
xxxxx xxxx xxxxxxxx předloženo xx xxxxx xxxxxxxxx v čl. 14 xxxx. 2 xxxx 3 tohoto xxxxxxxx a byly xxxxxxxx xxxxxxxxx xxxxx xx. 17 xxxx. 5 xxxxxx nařízení, xxx xxxxxxxx xxxxx x xxxxxxxx xxxxxxxx xxxxx xxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX xxxxxx nařízení. |
X xxxxxxx xxxxxxxx x xxxxxx xxxxxxxxxxx xxxx. x) xx xxxxx xxxxxxxxxx x xxxxxxxxxxx xxxxxxxx na xxxxxx látku, xx xxxxxx xx xxxxxxxx xxxxxxxxx xxxxxxxx x xxxxxxx XX xxxxxx xxxxxxxx, xxxxx xxxxxx xxxxxxxx nebo xxxxxxxx xxxxxxxxxx x xxxxxxxxx.
KAPITOLA 4
XXXXXXXXX OPATŘENÍ
Článek 21
Xxxxxxxxx opatření pro xxxxx xxxxxxx x&xxxx;xxxxxx&xxxx;15
1.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx může pokračovat x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx nebo praxe xxxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxxxx xxxxxxxxxx xxxxxxxxx, který xxxxxxx ze xxxxxxxxx xxxxxx látky uvedené x xx. 15 xxxx. x) x x), tuto xxxxx xxxxxxxx xxxx z xx xxxxxx. X xxxxxx případech:
|
a) |
nesmí xxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx na trh s účinkem xx&xxxx;24 xxxxxx xx xxxx vstupu xxxxxx xxxxxxxx v platnost; |
|
b) |
stávající xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxx xxxx xxxxxxxxx xx&xxxx;30 xxxxxx xx xxx xxxxxx xxxxxx xxxxxxxx x&xxxx;xxxxxxxx. |
2.&xxxx;&xxxx;&xxxx;Xxxxxxx stát xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx xxxxx stávajícího xxxxxxx xxxx xxxxx xxxxxxxx xx&xxxx;xxx a používání xxxxxxxxxx xxxxxxxxx, xxxxx xxxxxxx xx xxxxxxxxx účinné xxxxx uvedené v xx. 15 xxxx. x), xxxx látku xxxxxxxx nebo x xx xxxxxx. X xxxxxx xxxxxxxxx:
|
x) |
xxxxx xxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;24 xxxxxx po xx z xxxx xxxxxxxxx xxxxxxxx, xxxxx xxxxxxx xxxxxxx:
|
|
b) |
stávající xxxxxx xxxxxxxxxx xxxxxxxxx xxxxx xxx dále xxxxxxxxx xx&xxxx;30 xxxxxx xx té z xxxx xxxxxxxxx xxxxxxxx, xxxxx xxxxxxx xxxxxxx:
|
3.&xxxx;&xxxx;&xxxx;Xxxxxxx xxxx xxxx xxxxxxxxxx x&xxxx;xxxxxxxxxxx xxxxx xxxxxxxxxxx xxxxxxx xxxx xxxxx xxxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxxxx xxxxxxxxxx xxxxxxxxx, xxxxx xxxxxxx xx xxxxxxxxx účinné xxxxx xxxxxxxxxx agenturou xxxxx xx. 16 xxxx. 4 pro příslušný xxx xxxxxxx, tuto xxxxx xxxxxxxx xxxx x xx xxxxxx. X těchto případech:
|
a) |
nesmí xxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxx xx&xxxx;xxx x&xxxx;xxxxxxx xx&xxxx;xxxxxxxx xxxxxx xx xxxx, xxx xxxxxxxx xxxxxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxx článku 19 x |
|
x) |
xxxxxxxxx zásoby xxxxxxxxxx xxxxxxxxx xxxxx xxx xxxx xxxxxxxxx xx&xxxx;xxxxxxxx měsíců po xxxx uvedeného xxxxxxxxxx. |
Xxxxxx 22
Nezbytná xxxxxxx
1. Aniž xx dotčen xx. 55 xxxx. 1 xxxxxxxx (XX) x. 528/2012, xx xxxxxxxx měsíců xx xxxx xxxxxxxxxx o neschválení xxxxxxxxx xxxxxx látky, xxxxx členský stát xxxxxxxx xxxx xxxxxxxxx xxxxxxx látku xx xxxxxxxxx z důvodů uvedených x xx. 5 xxxx. 2 xxxxxx pododstavci xxxx. x) xxxx x) nařízení (EU) x. 528/2012, xxxxx xxxxxxx xxxx xxxx xxxxxxxxx Xxxxxx xxxxxxxxxxx xxxxxx x xxxxxxxx xx xx. 89 xxxx. 2 xxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxx.
2. Xxxxxxxx xxxxxxx stát xxxxxxxx odůvodněnou xxxxxx xxxxxxxx xxxxxxxxxxxxxxx rejstříku. Xxxxx žádost xxxxxxxx xxxxxxx xxxxxxxxx, žádající xxxxxxx xxxx xxxx xxxxxxx xxxxxxxxx nedůvěrné xxxxx.
3. Xxxxxxxx zveřejní žádost xxxx případně xxxxxxxxxx xxxxx xxxxxxxxxxxxxx prostředky. Xxxxxxx xxxxx nebo xxxx osoby xxxxx xxxxx připomínky ve lhůtě 60 xxx xx xxxxxxxxxx.
4. Xx xxxxxxx xxxxxxxxxx xxxxxxxxxx xxxx Komise xxxxxxx odchylku od čl. 89 xxxx. 2 xxxxxxx xxxxxxxxxxx xxxxxxxx (XX) x. 528/2012, xxxxx umožní xxxxxx xxxxxxxx přípravky, jež xxxxxxxxx z této xxxxx, obsahují xx xxxx x xx xxxxxxxx, na trh xxxxxxxxxx xxxxxxxxx xxxxx x xxxxxxxx xx x xxxxx xxxxxxxx xxxxx x xxxxxxx x xxxxxxxxxxxxxx právními xxxxxxxx x x xxxxxxxx xxxxxxxx xxxxxxxx 5 x xxxxxxxxx xxxxxxx xxxxxxxx xxxxxxxxx Komisí.
5. Členský xxxx, xxxxx xx xxxxxxxx xxxxxxxx:
|
x) |
zajistí, xx xxxxx xxxxxxxxx xxxx omezeno xx xxxxxx xxxxxxx x xxxxxxx xxxx, xxx xxxx xxxxxx xxxxxxxx xxxxxxxx 1; |
|
x) |
xxxxxx vhodná xxxxxxxx xx xxxxxxxx xxxxx, aby xxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxxxx, xxxxxx xxxx xxxxxxxxx xxxxxxxxx; |
|
c) |
xxxxxxx, xxx xx hledala xxxxxxxxxxxx xxxxxx xxxx aby xxxx včas před xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxx x xxxxxxxxx xxxxxx látky v souladu xxxxxxx 7 xxxxxxxx (XX) x. 528/2012. |
XXXXXXXX 5
XXXXXXXXX XXXXXXXXXX
Xxxxxx 23
Xxxxxxx
Xxxxxxx xx xxxxxxxx (XX) x. 1451/2007.
Xxxxxx xx xxxxxxx xxxxxxxx xx xxxxxxxx xx xxxxxx xx xxxx xxxxxxxx.
Xxxxxx 24
Vstup x xxxxxxxx
Xxxx nařízení xxxxxxxx x xxxxxxxx xxxxxxxx xxxx po xxxxxxxxx x Úředním xxxxxxxx Xxxxxxxx xxxx.
Xxxx xxxxxxxx xx xxxxxxx v xxxxx xxxxxxx x xxxxx xxxxxxxxxx xx xxxxx xxxxxxxxx xxxxxxx.
X Bruselu xxx 4. srpna 2014.
Xx Komisi
předseda
Xxxx Xxxxxx XXXXXXX
(1) Úř. xxxx. X 167, 27.6.2012, s. 1.
(2) Nařízení Xxxxxx (XX) x. 1451/2007 xx xxx 4. xxxxxxxx 2007 x druhé xxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxxxxxxx v xx. 16 xxxx. 2 směrnice Xxxxxxxxxx xxxxxxxxxx x Xxxx 98/8/XX x xxxxxxx xxxxxxxxxx přípravků xx xxx (Xx. xxxx. X 325, 11.12.2007, x. 3).
(3)&xxxx;&xxxx;Xxxxxxxx Evropského parlamentu x Xxxx 98/8/ES xx xxx 16. xxxxx 1998 x xxxxxxx xxxxxxxxxx xxxxxxxxx xx trh (Xx. xxxx. X 123, 24.4.1998, x. 1).
(4) Rozsudek Soudního xxxxx (xxxxxxx senátu) xx xxx 1. xxxxxx 2012 (žádost o xxxxxxxxxx x předběžné xxxxxx: Xxxxxxxxxxx Xxxxxxx – Německo) – Xöxx GmbH proti Xxxxx XxxX (xxxxxxx xxxxxxxxxx přípravků xx xxx – xxxxxxxx 98/8/XX – xx. 2 odst. 1 xxxx. x) – xxxxx „xxxxxxxx xxxxxxxxx“ – přípravek, který xxxxxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxxx, xxxx xx xxxx, xxxxxxxx nebo xxxxxxxxxxx), C-420/10.
(5)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Xxxxxx (XX) x.&xxxx;88/2014 ze xxx 31.&xxxx;xxxxx 2014, xxxxxx xx xxxxxxx xxxxxx pro změnu xxxxxxx X&xxxx;xxxxxxxx Xxxxxxxxxx xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;528/2012 x&xxxx;xxxxxxxx xxxxxxxxxx xxxxxxxxx na trh x&xxxx;xxxxxx xxxxxxxxx (Úř. xxxx. L 32, 1.2.2014, s. 3).
(6) Nařízení Evropského xxxxxxxxxx x Xxxx (XX) x. 1272/2008 ze xxx 16. xxxxxxxx 2008 x xxxxxxxxxxx, xxxxxxxxxx a xxxxxx xxxxx a xxxxx, x změně a xxxxxxx xxxxxxx 67/548/EHS x 1999/45/ES x x změně xxxxxxxx (XX) č. 1907/2006 (Xx. xxxx. X&xxxx;353, 31.12.2008, x. 1).
(7)&xxxx;&xxxx;Xxxxxxxxx xxxxxxxx Komise (XX) č. 564/2013 xx xxx 18.&xxxx;xxxxxx 2013 x&xxxx;xxxxxxxxxx x&xxxx;xxxxxxxx xxxxxxxxx Xxxxxxxx agentuře xxx xxxxxxxx xxxxx xxxxx xxxxxxxx Evropského xxxxxxxxxx x&xxxx;Xxxx (XX) x.&xxxx;528/2012 x&xxxx;xxxxxxxx biocidních xxxxxxxxx xx trh x&xxxx;xxxxxx xxxxxxxxx (Xx.&xxxx;xxxx.&xxxx;X 167, 19.6.2013, x. 17).
(8) Nařízení Xxxxxxxxxx parlamentu x Rady (ES) x. 1907/2006 ze xxx 18. xxxxxxxx 2006 x xxxxxxxxxx, xxxxxxxxx, xxxxxxxxxx x xxxxxxxxx chemických xxxxx, x xxxxxxx Xxxxxxxx xxxxxxxx xxx xxxxxxxx xxxxx, x xxxxx xxxxxxxx 1999/45/XX a x xxxxxxx xxxxxxxx Xxxx (XXX) x.&xxxx;793/93, xxxxxxxx Xxxxxx (XX) x. 1488/94, směrnice Xxxx 76/769/XXX x xxxxxxx Xxxxxx 91/155/XXX, 93/67/XXX, 93/105/ES a 2000/21/XX (Xx. xxxx. X 396, 30.12.2006, x. 1).
XXXXXXX X
Xxxxxxxxx xxxxxxxxxx xxx xxxxxxxx xxxxx xxxxxx 17
Xxxxxxxx xxxxx xxxxxx 17 xxxxxxxx xxxx xxxxxxxxx:
|
1) |
důkaz, že látka xx xxxxxxxxx xxxxxxx xxxxxx xx xxxxxx xx. 3 xxxx. 1 xxxx. x) xxxxxxxx (XX) x. 528/2012; |
|
2) |
údaje x xxxx/xxxxxx xxxxxxxxx, xx xxxxx/x xx xxxxxxxx xxxxxxxx; |
|
3) |
xxxxxxxxx x xxxxx xxxxxxxx, xxxxx xxxx xxxxxx xxx účely xxxxxxx x xxxxxxxxx xx xxxxxxxx xx xxxxxxx X xxxxxxxx (XX) x. 528/2012, jakož x xxxxxxxxx xxxxx jejich xxxxxxxxx; |
|
4) |
xxxxxxxxx xxxxxxx x xxxxxxxx
|
|
5) |
pokud xxxx toto xxxxxxxx xxxxxxx x xxxxxxx xxxxxxxx x xx. 15 písm. x), xxxxx, xx xxxxx xxxx xx xxxx jako účinná xxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxxxx xx xxxxxxxxxxx xxxx xxxxxxxxx v den xxxxxxxx xxxx xxxxxxxxxx rozhodnutí xxxx pokynů xxxxxxxxx xx xxxxxxxx xxxxxxx. |
XXXXXXX II
XXXXXXXXX XXXXX X XXXX XXXXXXXXX XXXXXXXX XX XXXXXXXX XXXXXXXX XXX 4. XXXXX 2014
XXXX 1
Xxxxxxxxx účinné xxxxx x xxxx přípravku xxxxxxxxxxx xx xxx 4. xxxxx 2014, x xxxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxxxxxx xxx xxxx, xxxxx xxxx výslovně xxxxxxx x xxxxxxxxx 1017 x 1019.
|
Xxxxx xxxxxxx |
Xxxxx xxxxx |
Členský stát xxxxxxxxx |
Xxxxx ES |
Xxxxx CAS |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
17 |
18 |
19 |
21 |
22 |
|
1 |
formaldehyd |
DE |
200-001-8 |
50-00-0 |
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
6 |
5-{[2-(2-butoxyethoxy)ethoxy]methyl}-6- xxxxxx-1,3-xxxxxxxxxxx (xxxxxxxxxxxxxxxx/XXX) |
XX |
200-076-7 |
51-03-6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
9 |
xxxxxxxx |
XX |
200-143-0 |
52-51-7 |
|
x |
|
|
|
x |
|
|
x |
|
x |
x |
|
|
|
|
|
x |
|
29 |
xxxxxxxxxxx |
XX |
200-431-6 |
59-50-7 |
x |
x |
x |
|
|
x |
|
|
x |
|
|
|
x |
|
|
|
|
|
|
36 |
xxxxxxx |
XX |
200-578-6 |
64-17-5 |
x |
x |
|
x |
|
|
|
|
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|
|
|
|
|
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|
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|
|
37 |
xxxxxxxx xxxxxxxx |
XX |
200-579-1 |
64-18-6 |
|
x |
x |
x |
x |
x |
|
|
|
|
x |
x |
|
|
|
|
|
|
|
40 |
xxxxxx-2-xx |
XX |
200-661-7 |
67-63-0 |
x |
x |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43 |
xxxxxxxx xxxxxxxxxx |
XX |
200-712-3 |
69-72-7 |
|
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
45 |
propan-1-ol |
DE |
200-746-9 |
71-23-8 |
x |
x |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52 |
ethylenoxid |
X |
200-849-9 |
75-21-8 |
|
x |
|
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|
|
|
|
|
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|
|
|
|
|
|
|
|
|
60 |
xxxxxxxx xxxxxxxxx |
XX |
201-069-1 |
77-92-9 |
x |
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
|
69 |
xxxxxxxxx xxxxxxxx/2-xxxxxxxxxxxxxxx xxxxxxxx |
LT |
201-180-5 |
79-14-1 |
|
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
70 |
xxxxxxxx xxxxxxxxxxxx |
XX |
201-186-8 |
79-21-0 |
x |
x |
x |
x |
x |
x |
|
|
|
|
x |
x |
|
|
|
|
|
|
|
71 |
X-(+)-xxxxxx xxxxxxxx |
XX |
201-196-2 |
79-33-4 |
|
x |
x |
x |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
79 |
2-isopropenyl-8,9-dimethoxy-1,2,6,6a,12,12a-hexahydrochromeno[3,4-b]furo[2,3-h]chromen-6-on (xxxxxxx) |
XX |
201-501-9 |
83-79-4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
85 |
xxxxxxxxx |
XX |
201-782-8 |
87-90-1 |
|
x |
x |
x |
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
|
92 |
xxxxxxx-2-xx |
XX |
201-993-5 |
90-43-7 |
x |
x |
x |
x |
|
x |
x |
|
x |
x |
|
|
x |
|
|
|
|
|
|
113 |
xxxxxxxxxxxxx/3-xxxxxxxxx-2-xxxx (xxxxxxxxxxxxx) |
XX |
203-213-9 |
104-55-2 |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
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117 |
xxxxxxxx |
XX |
203-377-1 |
106-24-1 |
|
|
|
|
|
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|
|
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|
|
x |
x |
|
|
|
122 |
xxxxxxx |
XX |
203-474-9 |
107-22-2 |
|
x |
x |
x |
|
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|
|
|
|
|
|
|
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|
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133 |
xxxx-2,4-xxxxxxx xxxxxxxx (xxxxxxxx xxxxxxx) |
XX |
203-768-7 |
110-44-1 |
|
|
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|
x |
|
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136 |
xxxxxxxx (xxxxxxxxxxxxx) |
FI |
203-856-5 |
111-30-8 |
|
x |
x |
x |
|
x |
|
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|
x |
x |
|
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154 |
xxxxxxxxx |
N |
204-385-8 |
120-32-1 |
|
x |
x |
|
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|
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|
|
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|
|
|
171 |
2-fenoxyethan-1-ol |
XX |
204-589-7 |
122-99-6 |
x |
x |
|
x |
|
x |
|
|
|
|
|
|
x |
|
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|
|
172 |
xxxxxxxxxxxxxxx-xxxxxxx/1-xxxxxxxxxxxxxxxx-1-xxx-xxxxxxx |
UK |
204-593-9 |
123-03-5 |
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x |
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179 |
xxxx uhličitý |
XX |
204-696-9 |
124-38-9 |
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180 |
(natrium-kakodylát) – natrium-dimethylarsinát |
PT |
204-708-2 |
124-65-2 |
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185 |
xxxxxxxxxxxxxx, sodná xxx (xxxxx sůl xxxxxxxxxxxxxxx – xxxxxxxxx X) – (X-xxxxx-4-xxxxxxxxxxxx-1-xxxxxxxxxx |
XX |
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 |
xxxxxxx-xxxxxxx-2-xxxx |
ES |
205-055-6 |
132-27-4 |
x |
x |
x |
x |
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x |
x |
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x |
x |
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x |
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198 |
X-[(xxxxxxxxxxxxxx)xxxxxxxx]xxxxxxxx (xxxxxx) |
XX |
205-088-6 |
133-07-3 |
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x |
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x |
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206 |
xxxxxx |
XX |
205-286-2 |
137-26-8 |
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x |
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210 |
xxxxxx-xxxxxxx |
XX |
205-293-0 |
137-42-8 |
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x |
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x |
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227 |
2-(xxxxxxx-4-xx)xxxxxxxxxxxx (xxxxxxxxxxxx) |
ES |
205-725-8 |
148-79-8 |
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x |
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x |
x |
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235 |
xxxxxx |
DK |
206-354-4 |
330-54-1 |
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x |
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x |
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239 |
xxxxxxxxxxxxx |
XX |
206-992-3 |
420-04-2 |
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x |
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x |
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253 |
tetrahydro-3,5-dimethyl-1,3,5-thiadiazin-2-thion (xxxxxxx) |
BE |
208-576-7 |
533-74-4 |
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x |
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x |
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279 |
N-[(dichlorfluormethyl)sulfanyl]-N′,N′-dimethyl-N-(4-methylfenyl)sulfonamid (xxxxxxxxxxxx) |
XX |
211-986-9 |
731-27-1 |
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x |
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283 |
xxxxxxxxx |
XX |
212-950-5 |
886-50-0 |
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x |
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x |
x |
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288 |
X-[(xxxxxxxxxxxxxxxxxx)xxxxxxxx]-X-xxxxx-X′,X′-xxxxxxxxxxxxxxxx (xxxxxxxxxxxxx) |
UK |
214-118-7 |
1085-98-9 |
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x |
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289 |
thiokyanatan xxxxx |
XX |
214-183-1 |
1111-67-7 |
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x |
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292 |
[(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl]-trans-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyklopropan-1-karboxylát (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 vápenatý/vápno/pálené xxxxx/xxxxxxxx xxxxx |
XX |
215-138-9 |
1305-78-8 |
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x |
x |
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306 |
xxxx měďný |
XX |
215-270-7 |
1317-39-1 |
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x |
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315 |
xxxxx-2-xx-xxxxxxx |
XX |
215-661-2 |
1338-23-4 |
x |
x |
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321 |
monolinuron |
UK |
217-129-5 |
1746-81-2 |
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x |
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330 |
N-(3-aminopropyl)-N-dodecylpropan-1,3-diamin (xxxxxx) |
XX |
219-145-8 |
2372-82-9 |
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x |
x |
x |
|
x |
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x |
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x |
x |
x |
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336 |
X,X′-xxxxxxxx-2,2′-xxxxxxxxxxxxxxxxxxxxxx (XXXXX) |
XX |
219-768-5 |
2527-58-4 |
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x |
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339 |
1,2-xxxxxxxxxxxxxxx-3(2X)-xx (BIT) |
XX |
220-120-9 |
2634-33-5 |
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x |
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x |
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x |
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x |
x |
x |
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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 |
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x |
x |
x |
x |
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x |
x |
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345 |
xxxxxxx-xxxxxxxxxxxxxxxxxx |
XX |
220-767-7 |
2893-78-9 |
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x |
x |
x |
x |
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x |
x |
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348 |
xxxxx(xxxxxxxxx)xxxxxxxxxxxxxxx-xxxxx-xxxxxx (XXX) |
XX |
221-106-5 |
3006-10-8 |
x |
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354 |
xxxxxxxxx |
DK |
222-182-2 |
3380-34-5 |
x |
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359 |
(ethylendioxy)dimethanol (reakční xxxxxxxx ethylenglykolu a 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 |
pyridin-2-thiol-1-oxid, sodná xxx (xxxxxxxxx xxxxx) |
XX |
223-296-5 |
3811-73-2 |
|
x |
x |
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x |
x |
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x |
x |
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x |
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368 |
1-(3-xxxxxxxxxx)-3,5,7-xxxxxx-1-xxxxxxxxxxxxxxx-xxxxxxx (XXXX) |
XX |
223-805-0 |
4080-31-3 |
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x |
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x |
x |
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377 |
1,3,5-xxxx(2-xxxxxxxxxxxx)xxxxxxxxx-1,3,5-xxxxxxx (XXX) |
XX |
225-208-0 |
4719-04-4 |
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x |
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x |
x |
x |
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382 |
1,3,4,6-xxxxxxxx(xxxxxxxxxxxxx)xxxxxxxxxxxxxxxx[4,5-x]xxxxxxxx-2,5-xxxx (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 |
dimorfolinomethan (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 |
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x |
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x |
x |
x |
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401 |
xxxxxxx |
SE |
231-131-3 |
7440-22-4 |
|
x |
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x |
x |
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x |
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403 |
měď |
XX |
231-159-6 |
7440-50-8 |
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x |
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405 |
xxxx xxxxxxxx |
XX |
231-195-2 |
7446-09-5 |
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x |
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424 |
xxxxxx xxxxx |
XX |
231-599-9 |
7647-15-6 |
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x |
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x |
x |
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432 |
xxxxxxxx sodný |
XX |
231-668-3 |
7681-52-9 |
x |
x |
x |
x |
x |
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x |
x |
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434 |
xxxxxxxxxxxx |
XX |
231-711-6 |
7696-12-0 |
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x |
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439 |
xxxxxxx xxxxxx |
XX |
231-765-0 |
7722-84-1 |
x |
x |
x |
x |
x |
x |
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x |
x |
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444 |
7x-xxxxxxxxxxxx-1X,3X,5X-xxxxxxx[3,4-x]xxxxxx (XXXX) |
XX |
231-810-4 |
7747-35-5 |
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x |
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x |
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450 |
dusičnan stříbrný |
XX |
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 |
IT |
231-908-7 |
7778-54-3 |
|
x |
x |
x |
x |
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x |
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457 |
xxxxx |
IT |
231-959-5 |
7782-50-5 |
|
x |
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x |
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x |
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458 |
xxxxx xxxxxx |
XX |
231-984-1 |
7783-20-2 |
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x |
x |
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473 |
pyrethriny x xxxxxxxxxxx |
XX |
232-319-8 |
8003-34-7 |
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x |
x |
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491 |
xxxx xxxxxxxxxx |
XX |
233-162-8 |
10049-04-4 |
|
x |
x |
x |
x |
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x |
x |
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494 |
2,2-xxxxxx-2-xxxxxxxxxxxx (XXXXX) |
XX |
233-539-7 |
10222-01-2 |
|
x |
|
x |
|
x |
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x |
x |
x |
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501 |
xxxxxxxxxxx |
XX |
234-232-0 |
10605-21-7 |
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x |
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x |
x |
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515 |
xxxxxx amonný |
SE |
235-183-8 |
12124-97-9 |
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x |
x |
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522 |
zink-1-oxo-1λ5-pyridin-2-thiolát |
XX |
236-671-3 |
13463-41-7 |
|
x |
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x |
x |
|
x |
x |
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x |
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524 |
dodecylguanidin-monohydrochlorid |
XX |
237-030-0 |
13590-97-1 |
|
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x |
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x |
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526 |
xxxxxx-xxxxxxx-2-xxxx |
XX |
237-243-9 |
13707-65-8 |
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x |
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x |
x |
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x |
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529 |
brommonochlorid |
XX |
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 |
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x |
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x |
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534 |
bis(1-hydroxypyridin-2(1H)-thionato-O,S)měďnatý xxxxxxx (xxxxxxxxx mědi) |
XX |
238-984-0 |
14915-37-8 |
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x |
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541 |
natrium-4-chlor-3-methylfenolát |
XX |
239-825-8 |
15733-22-9 |
x |
x |
x |
|
|
x |
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x |
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x |
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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 |
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554 |
4-[(xxxxxxxxxxx)xxxxxxxx]-1-xxxxxxxxxxxx |
XX |
243-468-3 |
20018-09-1 |
|
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x |
x |
|
x |
x |
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559 |
[(xxxxxxxxxxxx-2-xx)xxxxxxxx]xxxxxx-xxxxxxxxxx (XXXXX) |
X |
244-445-0 |
21564-17-0 |
|
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x |
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x |
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562 |
[2-xxxxxx-4-xxx-3-(xxxx-2-xx-1-xx)xxxxxxxxx-2-xx-1-xx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (prallethrin) |
EL |
245-387-9 |
23031-36-9 |
|
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x |
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563 |
xxxxxx-(X,X)-xxxx-2,4-xxxxxxx (xxxxxx xxxxxxxx) |
XX |
246-376-1 |
24634-61-5 |
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x |
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x |
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566 |
α, α′,α′′-xxxxxxxxxxxxxxxxxx-1,3,5-xxxxxxx-1,3,5-xxxxxxxxxx (HPT) |
XX |
246-764-0 |
25254-50-6 |
|
x |
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x |
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x |
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x |
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571 |
2-xxxxxxxxxxxxxxxxxxxxxxxxx-3-xx (XXX) |
XX |
247-761-7 |
26530-20-1 |
|
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x |
x |
|
x |
x |
x |
|
x |
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577 |
xxxxxxxx(xxxxxxxxx)[3-(xxxxxxxxxxxxxxx)xxxxxx]xxxxxxx-xxxxxxx |
ES |
248-595-8 |
27668-52-6 |
|
x |
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x |
|
x |
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578 |
X2-xxxx-xxxxx-X4-xxxxxxxxxxx-6-(xxxxxxxxxxxxxx)-1,3,5-xxxxxxx-2,4-xxxxxx (xxxxxxxx) |
XX |
248-872-3 |
28159-98-0 |
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x |
|
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588 |
xxxxxxxxx-5,5-xxxxxxxxxxxxxxxxxxxx-2,4-xxxx (BCDMH/bromchlordimethylhydantoin) |
XX |
251-171-5 |
32718-18-6 |
|
x |
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x |
x |
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590 |
3-(4-xxxxxxxxxxxxxx)-1,1-xxxxxxxxxxxxxxxx/xxxxxxxxxxx |
XX |
251-835-4 |
34123-59-6 |
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x |
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x |
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597 |
1-[2-(xxxxxxxx)-2-(2,4-xxxxxxxxxxxx)xxxxx]xxxxxxxx (xxxxxxxx) |
XX |
252-615-0 |
35554-44-0 |
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x |
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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 |
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x |
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600 |
2-xxxx-2-(xxxxxxxxxx)xxxxxxxxxxxxxx (DBDCB) |
CZ |
252-681-0 |
35691-65-7 |
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x |
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961 |
xxxx xxxxxxxx-xxxxxxxxx/xxxxxxxxxxx xxxxx |
XX |
253-425-0 |
37247-91-9 |
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x |
x |
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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 |
cis- x xxxxx-x-xxxxxxx-3,8-xxxx (směs) (xxxxxxxxxx) |
XX |
255-953-7 |
42822-86-6 |
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x |
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614 |
(XX)-α-xxxxx-3-xxxxxxxxxxxx-(1XX)-xxx,xxxxx-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
257-842-9 |
52315-07-8 |
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x |
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615 |
3-xxxxxxxxxxxx(1XX,3XX;1XX,3XX)-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (permethrin) |
XX |
258-067-9 |
52645-53-1 |
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x |
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x |
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618 |
[1-xxxxxxx-2-xxxxxxxxxx-2-xx-1-xx]-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (xxxxxxxxxx) |
XX |
259-154-4 |
54406-48-3 |
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x |
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619 |
3-xxxxxxx-2-xx-1-xx-X-xxxxxxxxxxxxx (XXXX) |
XX |
259-627-5 |
55406-53-6 |
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x |
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x |
x |
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x |
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620 |
xxxxxxxx(xxxxxxxxxxxxx)xxxxxxxxx-xxxxxx (2:1) (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 (propikonazol) |
FI |
262-104-4 |
60207-90-1 |
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x |
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635 |
alkyltrimethylammoniumchlorid xxxxxxxxxx xxxxx (XXXXX/XXXX) |
XX |
263-038-9 |
61789-18-2 |
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x |
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648 |
4,5-xxxxxxx-2-xxxxxxxxxxxxxxx-3(2X)-xx (4,5-dichlor- 2-xxxxx-2X-xxxxxxxxxx-3-xx (XXXXX)) |
X |
264-843-8 |
64359-81-5 |
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x |
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x |
x |
x |
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649 |
1-(2-xxxxxxxxxxx)-3-[(xxxxxxxxxxxxxxx)xxxxx]xxxxxxxx (triflumuron) |
XX |
264-980-3 |
64628-44-0 |
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x |
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656 |
xxx(5-xxxxxxxxxxxxxxxx-3-xx)xxxxxx (xxxxxxxxxx/XXX) |
XX |
266-235-8 |
66204-44-2 |
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x |
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x |
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x |
x |
x |
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657 |
6-(xxxxxxxxxxxxxxxx)-1,3,5-xxxxxxx-2,4-xxxxxx (xxxxxxxxx) |
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) |
DE |
269-855-7 |
68359-37-5 |
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x |
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667 |
xxxxx(X12-18)xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (XXXXX (X12-18)) |
IT |
269-919-4 |
68391-01-5 |
x |
x |
x |
x |
|
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x |
x |
x |
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x |
|
671 |
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) |
IT |
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 |
|
x |
|
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 |
xxxxx(X10-X16)xxxxxxxxxxxxxxxxx |
PT |
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 |
|
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 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)) |
IT |
287-089-1 |
85409-22-9 |
x |
x |
x |
x |
|
|
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|
x |
x |
x |
|
|
|
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|
x |
|
725 |
alkyl(C12-C14)ethylbenzylammoniumchlorid (ADEBAC (X12-X14)) |
XX |
287-090-7 |
85409-23-0 |
x |
x |
x |
x |
|
|
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|
x |
x |
x |
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|
x |
|
731 |
xxxxxxxxx xxxxxxxxxxxx, Xxxxxxxxxxxxx xxxxxxxxxxxxxxxx, výtažek |
XX |
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 (xxxxxxxxxxxx) |
XX |
401-400-1 |
86479-06-3 |
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x |
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779 |
reakční xxxxxxxx xxxxxxxxx kyseliny a X-xxxxx(X12-X14)xxxxxx-1,2-xxxxxxx (xxxxxxxxxxxxx) |
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 |
|
|
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 |
|
|
x |
|
x |
|
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|
794 |
sek-butyl-2,2-(2-hydroxyethyl)piperidin-1-karboxylát (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 |
Bacillus xxxxxxxxxx 2362, kmen XXXX-1743 |
XX |
xxxxxxxxxxxxxxx |
143447-72-7 |
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x |
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955 |
Bacillus xxxxxxxxxxxxx xxxxx. xxxxxxxxxxx, xxxx XX3X |
XX |
mikroorganismus |
xxxx relevantní |
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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) (xxxx XXXX/XXX) |
XX |
xxxx |
55965-84-9 |
|
x |
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x |
|
x |
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x |
x |
x |
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939 |
xxxxxxx xxxxx (xxxxxxxx reakcí xxxxxxxx xxxxxxx a xxxxxxxxx sodného in xxxx) |
XX |
xxxx |
xxxx xxxxxxxxxx |
|
x |
x |
x |
x |
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813 |
peroxyoktanová xxxxxxxx |
FR |
xxxx xxxxxxxxxx |
33734-57-5 |
|
x |
x |
x |
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|
1014 |
xxxxxxxx xxxxxx |
SE |
xxxx relevantní |
není xxxxxxxxxx |
|
x |
|
x |
x |
|
x |
|
x |
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|
849 |
3-xxxxxxxxxxxx-(1X,3XX)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxxxxxx) |
XX |
není 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 (Xxxxxxxx 20) |
XX |
xxxx xxxxxxxxxx |
139734-65-9 |
|
x |
x |
x |
|
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|
152 |
xxxxxxxx xxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-ethyl-5-methylhydantoinu s xxxxxx x xxxxxxx (XXXXX) |
XX |
xxxx x xxxxxxxxx |
xxxx x xxxxxxxxx |
|
|
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x |
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459 |
reakční xxxx xxxxx xxxxxxxxxxxx x xxxxxxxx stříbrného |
XX |
xxxx x xxxxxxxxx |
xxxx x xxxxxxxxx |
x |
x |
|
|
|
x |
x |
|
x |
x |
x |
|
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|
777 |
reakční xxxxxxxx 5,5-xxxxxxxxxxxxxxxxxx, 5-xxxxx-5-xxxxxxxxxxxxxxxx x xxxxxxx (XXXXX) |
XX |
xxxx x xxxxxxxxx |
xxxx x xxxxxxxxx |
|
|
|
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x |
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810 |
xxxxxxxxxxxxxx xxxx x xxxxxxx xxxxxxx |
XX |
xxxx x xxxxxxxxx |
308069-39-8 |
|
x |
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x |
|
x |
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|
824 |
xxxxxxxx-xxxxxxxxx xxxxxx |
XX |
xxxx 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 |
stříbro xxxxxxxxxxx xx xxxxx xxxxxxxxxx (jako xxxxxxxxxxxx xx xxxxx xxxxxxxxxx agregátu x xxxxxxxxxx částicemi xx xxxxxxxxxx) |
XX |
xxxx x xxxxxxxxx |
není x xxxxxxxxx |
|
|
|
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x |
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|
1019 |
xxxx xxxxxxxxx (xxxx xxxxxxxxxxxx xxxxxxx agregáty x xxxxxxxxxx) |
XX |
xxxx k dispozici |
68909-20-6 |
|
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|
|
|
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x |
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|
831 |
xxxxxxxxx |
XX |
xxxxxxxxx xx xxxxxxx xxxxxxx |
61790-53-2 |
|
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|
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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: 1X xxxxx, 1S: 1X xxx, 1X: 1X xxx, 1S 4:4:1:1) (x-xxxxxxxxx) |
XX |
xxxxxxxxx xx xxxxxxx xxxxxxx |
231937-89-6 |
|
|
|
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|
|
|
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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) |
DE |
xxxxxxxxx xx xxxxxxx xxxxxxx |
260359-57-7 |
|
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|
|
|
x |
|
|
|
|
848 |
X-[(6-xxxxx-3-xxxxxxx)xxxxxx]-X′-xxxx-X-xxxxxxxxxxxxxxxxxxx (xxxxxxxxxxx) |
BE |
xxxxxxxxx xx xxxxxxx rostlin |
160430-64-8 |
|
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|
|
|
|
|
x |
|
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|
|
835 |
esfenvalerát/(S)-(3-fenoxyfenyl)kyanmethyl-(S)-2-(4-chlorfenyl)-3-methylbutanoát (xxxxxxxxxxxx) |
XX |
xxxxxxxxx xx xxxxxxx xxxxxxx |
66230-04-4 |
|
|
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|
|
|
|
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|
|
x |
|
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|
836 |
[(3-xxxxxxxxxxxx)xxxxxxxxxx]-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxx-1-xxxxxxxxxx (α-cypermethrin) |
XX |
xxxxxxxxx na xxxxxxx rostlin |
67375-30-8 |
|
|
|
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|
|
|
|
|
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|
x |
|
|
|
|
843 |
4-brom-2-(4-chlorfenyl)-1-(ethoxymethyl)-5-(trifluormethyl)pyrrol-3-karbonitril (chlorfenapyr) |
PT |
přípravek xx ochranu rostlin |
122453-73-0 |
|
|
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x |
|
|
|
|
859 |
xxxxxxx X-xxxxxxxxxxxxxxxxx(XXXXXX 204-697-4) x (xxxxxxxxxxx)xxxxxxxx (XXXXXX 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 |
polymer |
27083-27-8/32289-58-0 |
x |
x |
x |
x |
x |
x |
|
|
x |
|
x |
|
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|
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|
868 |
xxxx(xxxxxxxx-1,5-xxxxxxxxx-1,6-xxxx-xxxxxxxxxxxx) |
XX |
xxxxxxx |
91403-50-8 |
x |
x |
x |
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
869 |
α-[2-(didecylmethylamonio)ethyl]-ω-[hydroxypoly(oxyethylen)-propionát] (Xxxxxx 26) |
IT |
xxxxxxx |
94667-33-1 |
|
x |
|
x |
|
|
|
x |
|
x |
|
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872 |
X-xxxxxxx-X-xxxxxxxxxxxxxxxxxxxx-xxxxx/ α, α ′-(xxxxxxxxxxxxx)xxx[ω-xxxxxxxxx(xxxxxxxxxx)]-xxx xx (xxxxxxxxxxx xxxxxx) |
XX |
polymer |
214710-34-6 |
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ČÁST 2
Xxxxxxxxx účinné látky x xxxx xxxxxxxxx xxxxxxxxxxxxx xx xxx 4. xxxxx 2014
Tato xxxx xxxx přílohy xxxxxxxx
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xxxxxxxxx xxxxx x xxxx xxxxxxxxx xxxxxxx v tabulce níže, xxxxxx xxxxxxxxxx nanoforem, |
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xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxx xxxxx a typu přípravku xxxxxxxxx v tabulce v části 1, xxxxx těch, xxxxx xxxx xxxxxxx x xxxxxxx, x |
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xxxxxxxx xxxxxxxxx všech xxxxxxxxx xxxxxxxx xxxxx x xxxx přípravku xxxxxxxxxxx xx 4. xxxxx 2014, x xxxxxxxx xxxx, xxxxx xxxx xxxxxxxx xxxxxxxxx. |
Xxxxxxxxx xxxxx a typu xxxxxxxxx x xxxxxxxxxxxxx zařazené xx této xxxxx xxxxx předmětem xxxxxxxxxx x xxxxxxxxxxx podle xxxxxx 20, xxxxxxxx xxxxx osoba xxxxxx xxxxxxxx do dvanácti měsíců xx xxxxxx xxxxxx xxxxxxxx x xxxxxxxx xxxxx xx. 14 odst. 3 xxxx xxxxx xx xxxxxx xxxxxxxx xxxxxxxxx xxxxx xx. 17 odst. 4 nebo 5.
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Xxxxx položky |
Název látky |
Xxxxxxx xxxx xxxxxxxxx |
Xxxxx XX |
Xxxxx XXX |
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11 |
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17 |
18 |
19 |
21 |
22 |
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1021 |
1,3-xxxxxxx-5,5-xxxxxxxxxxxxxxxxx (xxxx definovaný xxxxx xxxxxxx 152) |
NL |
204-258-7 |
118-52-5 |
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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 položka 948) |
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204-527-9 |
122-19-0 |
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213 |
benzyl(dodecyl)dimethylamonium-chlorid (xxx položka 948) |
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205-351-5 |
139-07-1 |
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214 |
xxxxxx(xxxxxxxx)xxxxxxxxxxxxxxxxx-xxxxxxx (xxx položka 948) |
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205-352-0 |
139-08-2 |
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227 |
2-(xxxxxxx-4-xx)xxxxxxxxxxxx (xxxxxxxxxxxx) |
XX |
205-725-8 |
148-79-8 |
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x |
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331 |
xxxxxxxxxxxxxxxxxxxxxx-xxxxxx (xxx položka 949) |
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219-234-1 |
2390-68-3 |
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384 |
xxxxxxxx(xxxxxxx)xxxxxxx-xxxxxxx (xxx xxxxxxx 949) |
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226-901-0 |
5538-94-3 |
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399 |
xxxxxx(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxx (viz xxxxxxx 948) |
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230-698-4 |
7281-04-1 |
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401 |
xxxxxxx |
XX |
231-131-3 |
7440-22-4 |
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x |
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418 |
xxxx xxxxxxxxx xxxxxxx |
XX |
231-545-4 |
7631-86-9 |
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x |
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449 |
síran xxxxxxx |
XX |
231-847-6 |
7758-98-7 |
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x |
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1016 |
xxxxxxx stříbrný |
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-[(xxxxxxxxxxx)xxxxxxxx]-1-xxxxxxxxxxxx |
UK |
243-468-3 |
20018-09-1 |
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x |
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587 |
xxxxx(xxxxxxxx)xxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 949) |
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251-035-5 |
32426-11-2 |
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601 |
xxxxxxxxxxxxxx(xxxxxxx-9-xx-1-xx)xxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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253-363-4 |
37139-99-4 |
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615 |
3-xxxxxxxxxxxx(1XX,3XX;1XX,3XX)-3-(2,2-xxxxxxxxxxxx)-2,2-xxxxxxxxxxxxxxxxxxxxxxxxxxxxx (permethrin) |
XX |
258-067-9 |
52645-53-1 |
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x |
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637 |
alkyl(benzyl)dimethylamonium-chloridy (xxxxx odvozen xx xxxxxxxx xxxxxxx kokosového xxxxx) (viz položka 948) |
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263-080-8 |
61789-71-7 |
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638 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxxx xxxxxxx xx mastných xxxxxxx xxxxxxxxxx xxxxx) (viz xxxxxxx 949) |
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263-087-6 |
61789-77-3 |
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639 |
xxxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxxx xxxxxxx od xxxxxxxxxxxxxxx xxxxxxxx kyselin 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) |
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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 |
alkyl(C10-C16)benzyl(dimethyl)amonium-chloridy (xxx xxxxxxx 948) |
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273-544-1 |
68989-00-4 |
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692 |
xxxxx(X10-X16)xxxxxxxxxxxxxxxxx |
XX |
274-687-2 |
70592-80-2 |
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x |
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697 |
dialkyl(C8-C18)dimetylamonium-chloridy (xxx položka 949) |
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277-453-8 |
73398-64-8 |
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1000 |
dihydrogen-bis(monoperoxyftalato)magnesát xxxxxxxxxx |
XX |
279-013-0 |
14915-85-4 |
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x |
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998 |
xxxxxxx margosy jiný xxx z jader xxxxxxxx Azadirachta xxxxxx xxxxxxxxxxx xxxxx x xxxx zpracovaný xxxxxxxxxxx xxxxxxxxxxxx |
XX |
283-644-7 |
84696-25-3 |
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x |
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741 |
xxxxx(X8-X18)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxx (viz 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 definovaný xxxxx xxxxxxx 777) |
XX |
401-570-7 |
89415-87-2 |
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x |
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778 |
1-(4-xxxxxxxxxx)-4,4-xxxxxxxx-3-[(1X-1,2,4-xxxxxxx-1-xx)xxxxxx]xxxxxx-3-xx (xxxxxxxxxxx) |
XX |
403-640-2 |
107534-96-3 |
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x |
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805 |
xxxxxxx produkt xxxxxxxx-xxxxxxx, xxxxxxxx-xxxxxxxxx x xxxxxxxx-xxxxxxxxx x peroxidem xxxxxx (xxxxxxxx) |
XX |
432-790-1 |
xxxx xxxxxxxxxx |
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x |
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923 |
xxxxx(xxxxxx)xxxxxxxxxxxxxxx-xxxxxxx/xxxxxxxxxxxx-xxxxxxx (xxx xxxxxxx 948) |
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xxxx |
8001-54-5 |
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949 |
(xxxxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -bromidy xxxx -xxxxxx-xxxxxxx) (alkyly (X6-X18) xxxxxxxx x xxxxxxxxxx, odvozené od xxxxxxxx kyselin xxxx, xxxxxxxxxx oleje x xxxxxxxx xxxxx) (XXXX) |
XX |
xxxx xxxxx xxxxxxxxx v xxxxxxx XXXXXX |
není relevantní |
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950 |
alkyltrimethylamonium-chloridy, -xxxxxxx xxxx -xxxxxx-xxxxxxx) (xxxxxx (C8-C18) xxxxxxxx x nenasycené, xxxxxxxx xx mastných xxxxxxx xxxx, xxxxxxxxxx xxxxx x sójového xxxxx) (XXXX) |
XX |
xxxx xxxxx uvedených x xxxxxxx EINECS |
není xxxxxxxxxx |
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x |
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948 |
xxxxxx(xxxxx)xxxxxxxxxxxxxxx-xxxxxxxx, -xxxxxxx xxxx -xxxxxxxxx) (alkyly (C8-C22) xxxxxxxx x nenasycené, xxxxxxxx od xxxxxxxx xxxxxxx xxxx, xxxxxxxxxx xxxxx x xxxxxxxx xxxxx) (XXX) |
XX |
xxxx xxxxx xxxxxxxxx x xxxxxxx XXXXXX |
xxxx xxxxxxxxxx |
x |
x |
x |
x |
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x |
x |
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849 |
3-xxxxxxxxxxxx-(1X,3XX)-2,2-xxxxxxxx-3-(2-xxxxxxxxxx-1-xx-1-xx)xxxxxxxxxxx-1-xxxxxxxxxx (x-xxxxxxxxx) |
IE |
xxxx xxxxxxxxxx |
188023-86-1 |
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x |
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1001 |
xxxxx(X12-X16)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx (xxxx xxx látka xxxxxxxxx pod xxxxxxx 671) |
XX |
xxxx relevantní |
xxxx relevantní |
x |
x |
x |
x |
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1002 |
xxxxx(X12-X18)xxxxxx(xxxxxxxx)xxxxxxx-xxxxxxxx(xxxx xxx látka xxxxxxxxx xxx položku 667) |
IT |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
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x |
x |
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x |
x |
x |
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1003 |
xxxxx(X12-X18)(xxxxxxxxxxx)xxxxxxxxxxxxxxx- chloridy (xxxx xxx xxxxx xxxxxxxxx pod položku 725) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
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x |
x |
x |
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x |
x |
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1005 |
alkyl(C12-C14)benzyl(dimethyl)amonium-chloridy (xxxx než látka xxxxxxxxx xxx xxxxxxx 724) |
XX |
xxxx relevantní |
xxxx xxxxxxxxxx |
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x |
x |
x |
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x |
x |
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1006 |
xxxxxxxxxxxxxx xxxx obsahující xxxxxxx, xxxxx, hliník x xxx |
XX |
xxxx relevantní |
398477-47-9 |
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1009 |
xxxxxxx(X8-X10)xxxxxxxxxxxxxx-xxxxxxxx (xxxx xxx xxxxx xxxxxxxxx xxx položku 673) |
XX |
xxxx xxxxxxxxxx |
xxxx relevantní |
x |
x |
x |
x |
x |
x |
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x |
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1011 |
xxxxx(xxxxxxxxx)xxxxxxx-xxxxxxxx (xxxxx xxxxxxx od xxxxxxxx xxxxxxx xxxxxxxxxx oleje) (xxxx než xxxxx xxxxxxxxx xxx xxxxxxx 635) |
XX |
xxxx xxxxxxxxxx |
xxxx xxxxxxxxxx |
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1012 |
xxxxxxxxxxxxxxxxx xxxxx, xxxxxxxx a xxxxxxxxx xxxxxxx/xxxxxxxx-xxxxxxxxx xxxxxx |
XX |
není xxxxxxxxxx |
130328-20-0 |
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598 |
(±)-1-(β-xxxxxxxx-2,4-xxxxxxxxxxxxxxxxx)xxxxxxxx (imazalil technický) |
XX |
xxxxxxxxx xx xxxxxxx rostlin |
73790-28-0 |
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XXXXXXX XXX
Xxxxx
|
Xxxx přípravků |
Xxxxx xxx xxxxxxxxxx xxxxxxxxx xxxxxx xxxxx čl. 6 odst. 3 xxxx. x) |
Xxxxx xxx xxxxxxxx xxxxxxxx stanoviska xxxxx xx. 7 xxxx. 2 xxxx. x) |
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8, 14, 16, 18, 19 x 21 |
31.12.2015 |
31.3.2016 |
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3, 4 x 5 |
31.12.2016 |
31.3.2017 |
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1 x 2 |
31.12.2018 |
31.3.2019 |
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6 a 13 |
31.12.2019 |
31.3.2020 |
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7, 9 x 10 |
31.12.2020 |
31.3.2021 |
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11, 12, 15, 17, 20 a 22 |
31.12.2022 |
31.9.2023 |