• No results found

Active components in food supplements | RIVM

N/A
N/A
Protected

Academic year: 2021

Share "Active components in food supplements | RIVM"

Copied!
66
0
0

Bezig met laden.... (Bekijk nu de volledige tekst)

Hele tekst

(1)UHVHDUFKIRU PDQDQGHQYLURQPHQW. 5,-.6,167,7887922592/.6*(=21'+(,'(10,/,(8 1$7,21$/,167,787(2)38%/,&+($/7+$1'7+((19,5210(17. 5,90UHSRUW $FWLYHFRPSRQHQWVLQIRRGVXSSOHPHQWV 0 6LHPHOLQN(+0--DQVHQ$+3LHUVPD $ 2SSHUKXL]HQ $SULO. 7KLVLQYHVWLJDWLRQKDVEHHQSHUIRUPHGE\RUGHUDQGIRUWKHDFFRXQWRIWKH'LUHFWRUDWHIRU 3XEOLFKHDOWKRIWKH0LQLVWU\RI+HDOWK:HOIDUHDQG6SRUWZLWKLQWKHIUDPHZRUNRISURMHFW µ+HDOWKSURPRWLQJFRPSRQHQWVRIQXWULWLRQ¶. 5,9032%R[%$%LOWKRYHQWHOHSKRQHWHOHID[.

(2) SDJHRI. 0DLOLQJOLVW 1. Dr. H.J. Schneider, Directeur-Generaal Volksgezondheid 2. Dr. W.H. van Eck, wnd. directeur Directie Gezondheidsbeleid 3. Prof. dr. J.J. Sixma, voorzitter Gezondheidsraad 4. Ir. R. Top, directie Gezondheidsbeleid, VWS 5. S.M.C. Potting, directie Gezondheidsbeleid, VWS 6 Ir. J.M. de Stoppelaar, directie Gezondheidsbeleid, VWS 7 Dr.ir. M.W.J. Wolfs, Algemeen Directeur IWV 8 Mr. ing. G.J.B. Koenen, Algemene Directie IWV 9 Drs. H. de Sitter, IWV 10 Drs. N. Blok, IWV 11 Ir. H.M.M. Roomans, IWV-Zuid 12 Ir. B.C. Breedveld (Voedingscentrum, Den Haag) 13 Dr. J.H. Brussaard (TNO-Voeding, Zeist) 14 Dr. A.H. Severs (TNO Vitamine Informatie Bureau, Zeist) 15 Depot Nederlandse Publicaties en Nederlandse Bibliografie 16 Directie RIVM 17 Prof. dr. ir. D. Kromhout (SB2) 18 Prof. dr. P.W.J. Peters (BIS) 19 Dr. A. Opperhuizen (LEO) 20 Prof. dr. ir. J.C. Seidell (CZE) 21 Dr. ir. H.J.G.M. Derks (LGO) 22 Dr. P. van Zoonen (LOC) 23 Dr. ir. E. Lebret (LBM) 24 Dr. H.B. Bueno de Mesquita (CZE) 25 Ir. H. van Egmond (ARO) 26 Dr. D. de Kaste (LGO) 27 Drs. A.G.A.C. Knaap (CSR) 28 Dr. A.K.D. Liem (LOC) 29 Dr.ir. M.C. Ocké (CZE) 30 Dr. ir. E.H.J.M. Jansen (LEO) 31 Dr. C.F. van Kreyl (LEO) 32 Dr. A.H Piersma (LEO) 33 Ing. E. Schenk (LEO) 34 Drs. M. Siemelink (LEO) 35 Drs. M.Q.I. Spanjersberg (LEO) 36 A. Verhoef (LEO) 37 Dr. W. Vleeming(LEO) 38 Prof. dr. D.J. de Wildt (LEO) 39 Hoofd Bureau Voorlichting en Public Relations (RIVM). 5,90UHSRUW.

(3) 5,90UHSRUW. 40-44 45-60 61 62-71. Bureau Rapportenregistratie (RIVM) Bureau Rapportenbeheer (RIVM) Bibliotheek RIVM Reserve-exemplaren. SDJHRI.

(4) SDJHRI. 5,90UHSRUW. $EVWUDFW 7KHJURZLQJIRRGVXSSOHPHQWPDUNHWZKHUHVXSSOHPHQWVDUHERWKPRUHGLYHUVHDQGPRUH HDVLO\DYDLODEOH HJWKURXJK,QWHUQHW

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‰FDURWHQHFRXOGEHLGHQWLILHG7KHVDIHW\OHYHOVRIWKH KRUPRQHVGHK\GURHSLDQGURVWHURQHDQGPHODWRQLQKDYH\HWWREHGHWHUPLQHGWKH\KDYHEHHQ UHSRUWHGWREHUHVSRQVLEOHIRUDGYHUVHVLGHHIIHFWV.

(6) 5,90UHSRUW. SDJHRI. &RQWHQWV 6800$5<   ,1752'8&7,21  $&7,9(&20321(176  5(68/76   &21&/86,216  5()(5(1&(6,  5()(5(1&(6,,  $33(1',;,:$7(562/8%/(9,7$0,16 $33(1',;,,)$762/8%/(9,7$0,16  $33(1',;,,,0$-250,1(5$/6  $33(1',;,975$&((/(0(176 $33(1',;9+25021(6  $33(1',;9,)$77<$&,'6 $33(1',;9,,$662&,$7('1875,7,21$/)$&7256 .

(7) SDJHRI. 5,90UHSRUW. 6DPHQYDWWLQJ ,QGLWUDSSRUWLVHHQLQYHQWDULVDWLHJHPDDNWYDQGHDFWLHYHFRPSRQHQWHQGLHDDQZH]LJ]LMQLQ YRHGLQJVVXSSOHPHQWHQ9DQHONHFRPSRQHQWLVKHWYROJHQGHZHHUJHJHYHQPLQLPXP EHKRHIWHDDQEHYROHQGDJHOLMNVHKRHYHHOKHLG $'+

(8) WR[LVFKHGRVLVZDDUJHQRPHQ KRHYHHOKHLGLQVXSSOHPHQWHQEURQQHQHQIXQFWLHYDQGHFRPSRQHQWHQV\PSWRPHQGLH RSWUHGHQELMGHILFLsQWLH'HYHHOYRRUNRPHQGHVWRIIHQLQYRHGLQJVVXSSOHPHQWHQ]LMQ RQGHUYHUGHHOGLQGHYROJHQGHFDWHJRULHsHQZDWHUHQYHWRSORVEDUHYLWDPLQHVPLQHUDOHQ VSRRUHOHPHQWHQKRUPRQHQYHW]XUHQHQDDQYHUZDQWHYRHGLQJVIDFWRUHQ 'HDFWLHYHYRHGLQJVFRPSRQHQWHQNXQQHQRQGHUYHUGHHOGZRUGHQLQWZHHJOREDOHFDWHJRULHsQ FRPSRQHQWHQGLHYHLOLJ]LMQELMHHQLQQDPHYDQPLQVWHQVNHHUGH$'+HQZDDUYDQ YHURQGHUVWHOGZRUGWGDWJHHQWR[LVFKHHIIHFWHQRSWUHGHQELMQRUPDDOJHEUXLNHQLQGHWZHHGH FDWHJRULHYDOOHQVWRIIHQGLHHHQYHLOLJHPDUJHKHEEHQYDQPLQGHUGDQNHHUGH$'+HQ ZDDUYDQ UHGHOLMNHUZLMVPDJZRUGHQDDQJHQRPHQRIYHUZDFKWGDW]HELMRYHUGRVHULQJRIELM ULVLFRJURHSHQQHJDWLHYHHIIHFWHQRSGHJH]RQGKHLGYHURRU]DNHQ'HYROJHQGHFRPSRQHQWHQ EHKRUHQWRWGHODDWVWHFDWHJRULHYDQGHZDWHURSORVEDUHYLWDPLQHVLVHHQKRJHYLWDPLQH& LQQDPHPRJHOLMNVFKDGHOLMNELMPHQVHQPHWHHQYHUVWRRUGLM]HUPHWDEROLVPH ELMY KHPRFKURPDWRVH

(9) (HQKRJHIRODDWLQQDPHNDQKHWEHVWDDQYDQHHQYLWDPLQH% GHILFLsQWLH PDVNHUHQ 9DQGHYHWRSORVEDUHYLWDPLQHV]LMQYLWDPLQH$HQ'VFKDGHOLMNELMHHQUHODWLHIODJHLQQDPH (HQLQQDPHYDQYLWDPLQH$YDQRQJHYHHUDFKWNHHUGH$'+NDQELM]ZDQJHUHYURXZHQ DIZLMNLQJHQDDQGHYUXFKWYHURRU]DNHQ.LQGHUHQOLMNHQRRNHUJJHYRHOLJWH]LMQYRRU K\SHUYLWDPLQRVH'(HQKRJHLQQDPHYDQYLWDPLQH(NDQLQWHUIHUHUHQPHWGHEORHGVWROOLQJHQ LV GDDURPELMSDWLsQWHQPHWDQWLVWROOLQJVWKHUDSLHDIWHUDGHQ9RRUZDWEHWUHIWGHPLQHUDOHQ ]RX GHLQQDPHYDQ]LQNEHSHUNWPRHWHQEOLMYHQWRWWZHHWRWYLHUNHHUGH$'+(HQKRJH FDOFLXPLQQDPH !NHHUGH$'+

(10) NDQJDVWURLQWHVWLQDOHVWUHVVYHURRU]DNHQ9HUGHUKHHIW VHOHQLXPHHQELM]RQGHUODJHYHLOLJHPDUJHYDQLQQHPLQJ9DQGHDDQYHUZDQWHQXWULWLRQHOH IDFWRUHQVWDDW‰FDURWHHQLQGHEHODQJVWHOOLQJYDQZHJHKHWWRHJHQRPHQULVLFRRSORQJNDQNHU LQ URNHUVQDFKURQLVFKHFRQVXPSWLHYDQ‰FDURWHHQYDQPLQVWHQVWLHQNHHUGH$'+ YHUJHOHNHQPHWGHFRQWUROHJURHS +HWYHUKRJHQYDQGHLQQDPHYDQHHQVSHFLILHNHFRPSRQHQWNDQGHRSQDPHYDQRILQWHUDFWLH PHWDQGHUHFRPSRQHQWHQZLM]LJHQHQ]RHHQRQEDODQVFUHsUHQ(HQYRRUEHHOGKLHUYDQLVHHQ PRJHOLMNHDIQDPHLQGHLM]HUDEVRUSWLHZDQQHHUVSHFLILHNHFDOFLXPVXSSOHPHQWHQZRUGHQ LQJHQRPHQZDDUGRRUSHUVRQHQPHWHHQPDUJLQDOHLM]HUVWDWXVHHQLM]HUGHILFLsQWLH RQWZLNNHOHQ(HQDQGHUZLOOHNHXULJYRRUEHHOGLVGDWQDHHQYHUKRRJGHFKURQLVFKH]LQN LQQDPHHHQNRSHUGHILFLsQWLHRQWVWDDWGRRUGDW]LQNKHWNRSHULQHQ]\PHQYHUYDQJW .

(11) 5,90UHSRUW. SDJHRI. 6XPPDU\ 7KLVUHSRUWGRFXPHQWVDQLQYHQWRU\RIWKHDFWLYHFRPSRQHQWVSUHVHQWLQIRRGVXSSOHPHQWV ,QIRUPDWLRQRQWKHPLQLPXPUHTXLUHPHQWUHFRPPHQGHGGDLO\DOORZDQFH 5'$

(12) WR[LFGRVH REVHUYHGGRVHLQVXSSOHPHQWVGLHWDU\VRXUFHVDQGWKHSK\VLRORJLFDOIXQFWLRQRIWKH FRPSRQHQW DQGGHILFLHQF\V\PSWRPVDUHJLYHQIRUHDFKFRPSRQHQW6XEVWDQFHVIUHTXHQWO\ IRXQGLQVXSSOHPHQWVOLNHZDWHUDQGIDWVROXEOHYLWDPLQVPDMRUPLQHUDOVWUDFHHOHPHQWV KRUPRQHVIDWW\DFLGVDQGDVVRFLDWHGQXWULWLRQDOIDFWRUVDUHLQFOXGHG 7KHDFWLYHFRPSRQHQWVLQIRRGVXSSOHPHQWVFDQEHGLYLGHGWHQWDWLYHO\LQWRWZREURDG FDWHJRULHV 0DUNV

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

(14) FDQPDVNWKHV\PSWRPVRIDYLWDPLQ% GHILFLHQF\  2IWKHIDWVROXEOHYLWDPLQVYLWDPLQV$DQG'KDYHDUHODWLYHO\ORZPDUJLQRIVDIHW\$ YLWDPLQ$LQWDNHRIDERXWHLJKWWLPHVWKH5'$E\SUHJQDQWZRPHQKDVEHHQDVVRFLDWHGZLWK ELUWKGHIHFWV&KLOGUHQDOVRDSSHDUWREHSDUWLFXODUO\VHQVLWLYHWRK\SHUYLWDPLQRVLV'$KLJK LQWDNHRIYLWDPLQ(LVFRQWUDLQGLFDWHGIRUSHRSOHUHFHLYLQJDQWLFRDJXODQWWKHUDS\ $PRQJWKHPDMRUPLQHUDOVHVSHFLDOO\LURQFDQFDXVHFKURQLFDGYHUVHHIIHFWVLQLQGLYLGXDOV ZLWKKHUHGLWDU\KHPRFKURPDWRVLV ERWKKRPRDQGKHWHUR]\JRWHV

(15) RULQWKRVHZKRWDNHLURQ VXSSOHPHQWDWLRQRQDUHJXODUEDVLV(VSHFLDOO\PHQRYHU\HDUVDQGSRVWPHQRSDXVDO ZRPHQPD\EHDWULVNRIGHYHORSLQJDWKHURVFOHURWLFGLVHDVHVDVDUHVXOWRILQFUHDVHGLURQ LQGXFHGR[LGDWLYHVWUHVV$PD[LPXPLQWDNHRIWLPHVWKH5'$LVDGYLVHGIRU]LQF$KLJK FDOFLXPLQWDNH LHPRUHWKDQWZLFHWKH5'$

(16) FDQFDXVHVHYHUDODGYHUVHHIIHFWVOLNH JDVWURLQWHVWLQDOGLVWXUEDQFHVDQGFRQVWLSDWLRQ)LQDOO\WKHVDIHW\PDUJLQRIVHOHQLXP DWUDFH HOHPHQW

(17) LVYHU\ORZ 2IWKHDVVRFLDWHGQXWULWLRQDOIDFWRUVVSHFLDODWWHQWLRQKDVWREHSDLGWR‰FDURWHQH7KLVLV EHFDXVHRIDQLQFUHDVHGLQFLGHQFHRIOXQJFDQFHUDPRQJPDOHVPRNHUVZLWKDFRQVWDQW FRQVXPSWLRQRI‰FDURWHQHLQGRVHVPRUHWKDQWHQWLPHVWKH5'$FRPSDUHGWRVPRNHUVZKR UHFHLYHGDSODFHER  7KHVDIHW\RIWKHKRUPRQHVGHK\GURHSLDQGURVWHURQH '+($

(18) DQGPHODWRQLQKDV\HWWREH GHWHUPLQHGEXWDGYHUVHVLGHHIIHFWVKDYHEHHQUHSRUWHG . . :KHQLQWHUSUHWLQJWKHGDWDRQHPXVWFRQVLGHUWKDWDQLQFUHDVHGLQWDNHRIRQHQXWULHQWPD\ KDYHFRQVHTXHQFHVIRUWKHOHYHORIRULQWHUDFWLRQZLWK DQ

(19) RWKHUQXWULHQW V

(20) DQGWKDW LPEDODQFHVFDQEHFUHDWHGHDVLO\2QHH[DPSOHLVWKHUHGXFWLRQLQPDJQHVLXPDQGLURQ.

(21) SDJHRI. 5,90UHSRUW. DEVRUSWLRQE\FHUWDLQIRUPVRIFDOFLXPVXSSOHPHQWV$QRWKHULVWKHRFFXUUHQFHRIDFRSSHU GHILFLHQF\ZKHQWKH]LQFLQWDNHLVKLJKGXHWR]LQFGLVSODFLQJFRSSHULQHQ]\PHV.

(22) 5,90UHSRUW. SDJHRI.  ,QWURGXFWLRQ 7KLVVWXG\LVSHUIRUPHGRQEHKDOIRIWKH0LQLVWU\RI+HDOWK:HOIDUHDQG6SRUW 'LUHFWRUDWH IRU 3XEOLF+HDOWK6HFWLRQ1XWULWLRQDQG9HWHULQDU\3ROLF\

(23) EHFDXVHRIWKHLUUHVSRQVLELOLWLHVLQ REVHUYLQJWKHUHJXODWLRQVRIWKH)RRGDQG'UXJV$FWDQGLQRXWOLQLQJSROLF\FRQFHUQLQJIRRG SURGXFWVDQGVXSSOHPHQWV'XULQJWKHODVWGHFDGHWKHDYDLODELOLW\RIIRRGVXSSOHPHQWVVXFK DV YLWDPLQSLOOVKRUPRQHVKHUEVHWFLVVWURQJO\LQFUHDVHGEHFDXVHRIDQLQFUHDVLQJ DZDUHQHVVRIWKHUHODWLRQVKLSEHWZHHQQXWULWLRQDQGKHDOWKLQWKHJHQHUDOSRSXODWLRQ%HVLGHV SKDUPDFLHVVXSSOHPHQWVFDQEHREWDLQHGIURPQRUPDODOLPHQWDU\VKRSVDQGHYHQE\,QWHUQHW VRXUFHV7KLVODVWSRVVLELOLW\RSHQVDZRUOGZLGHPDUNHWWRWKHFRQVXPHUZKLFKLVLQSULQFLSOH QRWFRQWUROODEOHE\WKHUHJXODWRU\DXWKRULWLHV 1RWRQO\WKHDPRXQWRIVXSSOHPHQWVKDVLQFUHDVHGEXWDOVRDQLQFUHDVLQJYDULHW\RI SUHSDUDWLRQVLVRIIHUHG7KLVFDWHJRU\RIIRRGVXSSOHPHQWVLVDOVRDUHODWLYHO\QHZDUHDIRUWKH 5HJLRQDO,QVSHFWLRQVRI3XEOLF+HDOWK 7KHUHIRUHLQWKLVUHSRUWDILUVWDWWHPSWLVPDGHWRVXPPDUL]HDQGFODVVLI\WKHDFWLYH FRPSRQHQWVLQIRRGVXSSOHPHQWVDVWKH\DUHRIIHUHGLQWKHORFDOVKRSVEXWDOVRRQ,QWHUQHW VRXUFHV7KLVUHSRUWFRQWDLQVLQIRUPDWLRQERWKRQWKHPLQLPDOUHTXLUHGGRVHWKH UHFRPPHQGHGDQGWKHWR[LFGRVHRIFRPSRQHQWVDVRQWKHSRVVLEOHDGYHUVHHIIHFWVRI GHILFLHQF\,QWKLVUHSRUWKHUEDOVXSSOHPHQWVZHUHQRWLQFOXGHGVLQFHDVHSDUDWHUHSRUWKDV UHFHQWO\ EHHQSXEOLVKHG . 7KHSUHVHQWUHSRUWLVWKHILUVWUHVXOWRIRXUVXUYH\XQWLO2FWREHU,WZLOOEHFOHDUWKDWWKH LQIRUPDWLRQHVSHFLDOO\RQWKHWR[LFHIIHFWVLVQRW\HWFRPSOHWH)XUWKHUPRUHWKHOLVWRIDFWLYH FRPSRQHQWVZLOOEHHQKDQFHGFRQWLQXRXVO\LQWKHIXWXUHDQGDOVRQHZLQIRUPDWLRQRQWKH SUHVHQWOLVWRIFRPSRXQGVZLOOEHLQFOXGHGLQODWHUYHUVLRQVRIWKLVUHSRUW.

(24) SDJHRI. 5,90UHSRUW.  $FWLYHFRPSRQHQWV ,QWKLVUHSRUWDFODVVLILFDWLRQKDVEHHQPDGHRIWKHDFWLYHFRPSRQHQWVLQIRRGVXSSOHPHQWV 2QO\FKHPLFDOO\ZHOOGHILQHGFRPSRQHQWVKDYHEHHQFRQVLGHUHGQRWWKHVXSSOHPHQWVRI KHUEDORULJLQDQGWKHDPLQRDFLGFRQWDLQLQJVXSSOHPHQWV2IWKHKRUPRQHSUHSDUDWLRQV PHODWRQLQDQGGHK\GURHSLDQGURVWHURQH '+($

(25) DUHGLVFXVVHGEHFDXVHRIVRPHUHFHQW SXEOLFLW\LQWKH1HWKHUODQGV :H KDYHFKRVHQIRUDGLVWLQFWLRQLQSURSHUWLHVDQGTXDQWLWLHVRIWKHFRPSRQHQWVLQVWHDGRID GLYLVLRQDFFRUGLQJWROHYHORIDGYHUVHHIIHFWRUWR[LFLW\WRPDNHLWSRVVLEOHWRXVHWKLVUHSRUW DV DTXLFNUHIHUHQFHJXLGH,QHDFKFDWHJRU\WKHFRPSRXQGVZKLFKDUHµFRPPRQO\¶IRXQGLQ PRVW RIWKHVXSSOHPHQWVDUHLQFOXGHG7RSXWWKHGDWDLQSHUVSHFWLYHRIWKHWR[LFGRVHDQ LQYHQWDULVDWLRQRIWKHµREVHUYHGGRVHLQVXSSOHPHQWV¶LVPDGHE\YLVLWLQJGLHWDU\VXSSOHPHQW VWRUHVRQWKH,QWHUQHWDQGE\REWDLQLQJGDWDIURPVXSSOHPHQWVLQORFDOVWRUHV $ GLYLVLRQLQWKHIROORZLQJFDWHJRULHVKDVEHHQPDGH  ZDWHUVROXEOHYLWDPLQV DSSHQGL[,

(26)  IDWVROXEOHYLWDPLQV DSSHQGL[,,

(27)  PDMRUPLQHUDOV DSSHQGL[,,,

(28)  WUDFHHOHPHQWV DSSHQGL[,9

(29)  KRUPRQHV DSSHQGL[9

(30)  IDWW\DFLGV DSSHQGL[9,

(31)  DVVRFLDWHGQXWULWLRQDOIDFWRUV DSSHQGL[9,,

(32) . . )RUHDFKFRPSRQHQWH[WHQVLYHLQIRUPDWLRQKDVEHHQFROOHFWHGLQDWDEOH ,QWDEOHDQRYHUYLHZLVJLYHQRIWKHDFWLYHFRPSRQHQWVZKLFKKDYHEHHQFRQVLGHUHGLQWKLV UHSRUWZLWKUHIHUHQFHWRWKHWDEOHVLQWKHDSSHQGLFHV.

(33) 5,90UHSRUW. SDJHRI. 7DEOHRYHUYLHZRIWKHDFWLYHFRPSRQHQWVGLVFXVVHGLQWKHDSSHQGLFHV. ZDWHUVROXEOHYLWDPLQV DSSHQGL[,

(34) WKLDPLQ YLWDPLQ%

(35) ULERIODYLQ YLWDPLQ%

(36) QLDFLQ YLWDPLQ%

(37) SDQWRWKHQLFDFLG YLWDPLQ%

(38) YLWDPLQ% ELRWLQ YLWDPLQ%

(39) IRODWH YLWDPLQ%

(40) YLWDPLQ% DVFRUELFDFLG YLWDPLQ&

(41). WDEOH         . SDJH         . IDWVROXEOHYLWDPLQV DSSHQGL[,,

(42) YLWDPLQ$ YLWDPLQ' YLWDPLQ( YLWDPLQ.. 7DEOH    . SDJH    . PDMRUPLQHUDOV DSSHQGL[,,,

(43) FDOFLXP PDJQHVLXP SRWDVVLXP LURQ ]LQF. 7DEOH     . SDJH     . WUDFHHOHPHQWV DSSHQGL[,9

(44) FRSSHU FREDOW LRGLQH IOXRULGH FKURPLXP PRO\EGHQXP VHOHQLXP. WDEOH       . 3DJH       . . . . . . . . .

(45) SDJHRI. 5,90UHSRUW. WDEOH±FRQWLQXHG. KRUPRQHV DSSHQGL[9

(46) PHODWRQLQ '+($. WDEOH  . 3DJH  . IDWW\DFLGV DSSHQGL[9,

(47) RPHJDIDWW\DFLGV RPHJDIDWW\DFLGV. WDEOH  . 3DJH  . DVVRFLDWHGQXWULWLRQDOIDFWRUV DSSHQGL[9,,

(48) TXHUFHWLQ OLSRLFDFLG FKROLQH FRHQ]\P4 FDUQLWLQH LQRVLWRO FUHDWLQH JOXFRVDPLQH O\FRSHQH ‰FDURWHQH. WDEOH. 3DJH.          .          .

(49) 5,90UHSRUW. SDJHRI.  5HVXOWV 0DUNV FRQVLGHUHGWKDWRQWKHEDVLVRIWKHUHYLHZHGLQIRUPDWLRQDFWLYHFRPSRQHQWVPD\EH GLYLGHGLQWRWZREURDGFDWHJRULHV $&RPSRXQGVZLWKDVDIHW\OHYHODWOHDVWWLPHVKLJKHUWKDQWKHUHFRPPHQGHGGDLO\ DOORZDQFH 5'$

(50) )URPWKHVHFRPSRXQGVQRVHULRXVDGYHUVHUHDFWLRQVFDQEHH[SHFWHG %&RPSRXQGVZLWKDVDIHW\OHYHORIDERXWWLPHVWKH5'$RUORZHU7KHVHFRPSRXQGV FDQFDXVHVHULRXVLUUHYHUVLEOHDGYHUVHUHDFWLRQVGHSHQGHQWRIWKHGRVHDQGRIWHQLQIOXHQFHG E\ WKHKHDOWKVWDWXVRIWKHLQGLYLGXDO 0RVWRIWKHFRPSRXQGVGLVFXVVHGLQWKLVUHSRUWIDOOLQFDWHJRU\$7KHYLWDPLQV$&'( IRODWHDQGFDOFLXP]LQFVHOHQLXPLURQDQGbFDURWHQHEHORQJWRFDWHJRU\%EHFDXVHRI UHSRUWHG DGYHUVHHIIHFWVRUWR[LFLWLHVRUEHFDXVHRIDQLQFUHDVHGULVNIRUFHUWDLQJURXSV . 7KHWR[LFRORJ\GDWDRIWKHYLWDPLQVLQGLFDWHWKDWDKLJKLQWDNHRIYLWDPLQ&LVVDIHIRU KHDOWK\SHUVRQVEXWPD\EHKDUPIXOXQGHUFRQGLWLRQVRIDGLVWXUEHGLURQKRPHRVWDVLVDQGD KLJK LQWDNHRUERG\VWRUHRILURQ $QH[FHVVRIYLWDPLQ&FDQFDXVHDQLQVWDQWDQHRXV UHOHDVHRIXQUHDFWLYH)H IURPIHUULWLQRUWUDQVIHUULQDQGFRQYHUW)H WRWKHWR[LF)H IRUP ZKLFK FDQJHQHUDWHWR[LFDPRXQWVRIIUHHUDGLFDOV,WLVHVWLPDWHG WKDWDERXWRIWKH &DXFDVLDQVLQ(XURSHKDYHDJHQHIRULURQRYHUORDG6RWKLVPLJKWEHDVHULRXVXQGHU HVWLPDWHGVLGHHIIHFWLQDORWRISHRSOH . . . . . 7KHYLWDPLQV$DQG'DUHUHODWLYHO\WR[LF%HFDXVHRIWKHLUIDWVROXEOHSURSHUWLHVWKH\ZLOOEH VWRUHG DQGDFFXPXODWHGLQDGLSRVHWLVVXHV,QWDNHVRIYLWDPLQ$RIWLPHVWKH5'$DUH ,QWDNHVRIWLPHVWKH5'$LQSUHJQDQF\KDYH WKRXJKW WREHSRWHQWLDOO\LQWR[LFDWLQJ EHHQ VKRZQWRFDXVHFRQJHQLWDOPDOIRUPDWLRQVDQGPHQWDOUHWDUGDWLRQLQRIIVSULQJ +\SHUYLWDPLQRVLV$FDXVHVPXVFOHDQGMRLQWSDLQVKHDGDFKHVNLQGLVRUGHUVDQGOLYHU GLVIXQFWLRQ'DLO\GRVHVRIYLWDPLQ'JUHDWHUWKDQDERXWWHQWLPHVWKH5'$ —J

(51) DUHQRW UHFRPPHQGHG(VSHFLDOO\\RXQJFKLOGUHQVHHPWREHVXVFHSWLEOHIRUK\SHUYLWDPLQRVLV' ,QWKH1HWKHUODQGVWKH&RPPRGLWLHV$FW([HPSWLRQ5HJXODWLRQ 

(52) IRUYLWDPLQ VXSSOHPHQWVUHVWULFWHGWKHGRVHRIUHWLQRLGVLQYLWDPLQ$SLOOVEHFDXVHRIWKHORZVDIHW\UDWLR WRWLPHVWKH5'$ —J

(53) 7KHGDLO\GRVHRIYLWDPLQ'LVUHVWULFWHGWR—JIRUWKH JHQHUDOSRSXODWLRQIRUFKLOGUHQXQGHU\HDUVDQGSUHJQDQWDQGODFWDWLQJZRPHQWKHGRVHLV UHVWULFWHG WR—J . . . 9LWDPLQ(LVUHODWLYHO\QRQWR[LFIRUKHDOWK\SHUVRQV+RZHYHUDKLJKGRVHRIYLWDPLQ(PD\ LQFUHDVHWKHDQWLFRDJXODQWHIIHFWVRISK\OORTXLQRQH YLWDPLQ.

(54) DQWDJRQLVWVDQGKHQFHDUH FRQWUDLQGLFDWHGGXULQJDQWLFRDJXODQWWKHUDS\ )XUWKHUPRUHVXSSOHPHQWDWLRQRIYLWDPLQ( DORQHFDQEHWKHFDXVHRIWKHFKDLQEUHDNLQJHIIHFWLQWKHGHWR[LILFDWLRQRIR[\JHQUDGLFDOV .

(55) SDJHRI. 5,90UHSRUW. $VIRUWKHYLWDPLQV$DQG'WKHGLIIHUHQFHEHWZHHQWKHUHFRPPHQGHGLQWDNHOHYHOIRUIRODWH DQG WKHLQWDNHOHYHODWZKLFKDGYHUVHHIIHFWVFDQQRWEHUXOHGRXWLVYHU\VPDOO&XUUHQWO\DQ XSSHUGDLO\LQWDNHRIPJIRODWHLVUHFRPPHQGHGEHFDXVHRIWKHPDVNLQJRIDYLWDPLQ % GHILFLHQF\ZLWKDKLJKHULQWDNH . . $ PRGHVWLQFUHDVHLQFDOFLXPLQWDNHVKRXOGEHVDIHIRUPRVWSHRSOH+RZHYHUDWRWDOFDOFLXP LQWDNHRYHUJGD\ aWLPHVWKH5'$

(56) FDQSURGXFHDGYHUVHHIIHFWVVXFKDVJDVWURLQWHVWLQDO GLVWXUEDQFHVFRQVWLSDWLRQDQGDWDFDOFLXPLQWDNHRIJUHDWHUWKDQJGD\KLJKEORRGFDOFLXP OHYHOVDQGVHYHUHUHQDOGDPDJH . 7KHPDUJLQEHWZHHQWKHVDIH]LQFLQWDNHOHYHO PJGD\

(57) DQGWKHUHFRPPHQGHGDPRXQW IRU ]LQF PJ

(58) LVYHU\VPDOOSDUWLFXODUO\LQSHRSOHZLWKORZFRSSHULQWDNH=LQFFRPSHWHV ZLWKFRSSHUDVFRIDFWRULQHQ]\PHVDQGLWFDQDOVRLQGXFHPHWDOORWKLRQHLQV QRQHQ]\PDWLF PHWDOELQGLQJSURWHLQV

(59) ZKLFKLQKLELWWKHDEVRUSWLRQRIFRSSHULQWKHLQWHVWLQH 6RDGYHUVH LQWHUDFWLRQVEHWZHHQFRSSHUDQG]LQFFDQRFFXUHYHQZKHUHWKHSURSRUWLRQEHWZHHQWKHVHWZR HOHPHQWVLQWKHGLHWLVUHODWLYHO\ORZ . 7KHSUHFLVHWKUHVKROGIRUDGYHUVHHIIHFWVRIVXSSOHPHQWDOLURQLVQRWNQRZQDQGLVSUREDEO\ DOVRGHSHQGHQWRQLQWDNHRIRWKHUPLQHUDOV HJPDQJDQHVH]LQFDQGSURWHLQ

(60) +RZHYHU FKURQLF LQWDNHRIKLJKLURQFDQUHVXOWLQH[FHVVLYHERG\LURQVWRUHVDQGLQWKHJHQHUDWLRQRI WR[LFDPRXQWVRIIUHHUDGLFDOVUHVXOWLQJLQRUJDQGDPDJH OLYHUSDQFUHDVKHDUWEUDLQ

(61)  1RUPDOLURQLQWDNHVFDQOHDGWRVLPLODUDGYHUVHHIIHFWVLQSHRSOHZKRDUHKRPRRU KHWHUR]\JRWHVIRUKHPRFKURPDWRVLV7KLVKHUHGLWDU\GLVHDVHLVFKDUDFWHUL]HGE\DQLQFUHDVHG LURQ RYHUORDGDOVRXQGHUQRUPDOGLHWDU\FRQGLWLRQV6LQFHLWLVHVWLPDWHGWKDWDERXWRIWKH SRSXODWLRQLVKHWHUR]\JRXV  LURQVXSSOHPHQWDWLRQVKRXOGEHDYRLGHGIRUPHQDQG SRVWPHQRSDXVDOZRPHQ$FRPELQHGKLJKLQWDNHRILURQDQGYLWDPLQ&VKRXOGEHDYRLGHGE\ WKHVHSHRSOH . )RUVHOHQLXPWKHGLIIHUHQFHEHWZHHQWKH5'$DQGWKHVDIHW\OHYHOLVUHODWLYHO\VPDOO7KH XSSHUOLPLWRIWKH5'$LVmJ ZKHUHDVmJ DSSHDUVWRSURGXFHDGYHUVHHIIHFWV  +RZHYHURWKHULQYHVWLJDWRUVUHSRUWWKDWDOHYHOXSWRmJ LVVDIH  (DUO\V\PSWRPVRI VHOHQLXPLQWR[LFDWLRQDUHIDWLJXHDQGJDVWURLQWHVWLQDOGLVWXUEDQFHVZKHUHDVQDLODQGKDLU DEQRUPDOLWLHVRFFXUDWGRVHVRYHUWLPHVWKH5'$ . . &DURWHQRLGVVXFKDV‰FDURWHQHDUHWKRXJKWWRKDYHEHQHILFLDOHIIHFWVLQSUHYHQWLQJYDULRXV GLVHDVHV &KURQLFFRQVXPSWLRQ \U

(62) RIPJ‰FDURWHQH WLPHVWKH5'$

(63)  KRZHYHU FDXVHGDQLQFUHDVHGUHODWLYHULVNRIOXQJFDQFHULQVPRNHUVFRPSDUHGWRVPRNHUV ZKR UHFHLYHGDSODFHER  7KHUHIRUHFKURQLFLQWDNHRIKLJKGRVHVRI‰FDURWHQHKDYHWREH DYRLGHGE\WKHVHSHRSOH .

(64) 5,90UHSRUW. SDJHRI. 0HODWRQLQLVDQHXURKRUPRQHZLWKDFLUFDGLDQSDWWHUQ,QWKH86$LWLVVROGRYHUWKH FRXQWHULQUHODWLYHO\KLJKGRVHV —JXSWRPJ

(65) ,QWKH1HWKHUODQGVPHODWRQLQ VXSSOHPHQWVXSWRDGRVHRI—JSHUVXSSOHPHQWDUHDOORZHGZKLFKDUHWKRXJKWWREH KDUPOHVV7KHUHLVODFNRILQIRUPDWLRQRQWKHWR[LFRORJ\RIWKLVKRUPRQH 6RPHVLGHHIIHFWV DUH UHSRUWHG K\SRWHQVLRQKHDGDFKHVQLJKWPDUHV

(66) EXWORQJWHUPVLGHHIIHFWVRULQWHUDFWLRQV ZLWK GUXJVRUQXWULHQWVDUHQRWNQRZQ0HODWRQLQLVSRVVLEO\DVWURQJDQWLR[LGDQW )RU'+($ GHK\GURHSLDQGURVWHURQH

(67) ERWKDQDQGURJHQDQGHVWURJHQSUHFXUVRUHYLGHQFHRID EHQHILFLDOHIIHFWRQDJLQJRUGLVHDVHLVFRQIOLFWLQJLQWKHOLWHUDWXUH 6RPHDGYHUVH LUUHYHUVLEOH

(68) HIIHFWVDVGHHSHQLQJRIWKHYRLFHDQGH[FHVVLYHKDLUJURZWKLQZRPHQKDYHEHHQ UHSRUWHG . . . +LJKGRVHGVXSSOHPHQWV LHDGRVHKLJKHUWKDQWKH5'$DQGUHODWLYHO\FORVHWRWKHDGYHUVH HIIHFW OHYHO

(69) DUHPDLQO\IRXQGLQ¶VLQJOHFRPSRQHQW¶VXSSOHPHQWVIURPWKH86$ 5HPDUNDEOHLVWKHKLJKVHOHQLXPGRVHLQVRPHVXSSOHPHQWVRIWKH86$XSWRWKHSRVVLEOH DGYHUVH HIIHFWOHYHO —J

(70) $OVRLQWKH86$DGRVHRIWZLFHWKH5'$RIPDJQHVLXPLV IRXQGLQPXOWLFRPSRQHQWVXSSOHPHQWVDOWKRXJKWKH ORQJWHUP

(71) WR[LFLW\RIDKLJKLQWDNHRI PDJQHVLXPLVXQNQRZQ.

(72) SDJHRI. 5,90UHSRUW. 6XSSOHPHQWXVDJHLQ7KH1HWKHUODQGV )URPWKHWKUHH)RRG&RQVXPSWLRQ6XUYH\VLQ7KH1HWKHUODQGVKHOGLQLQDQG LQWKHIROORZLQJFRQVXPSWLRQSDWWHUQVFDQEHGHGXFHG,QRIWKH 'XWFKSRSXODWLRQWDNHVVXSSOHPHQWV7KLVSHUFHQWDJHKDVLQFUHDVHGIURPLQXS WRLQ$SRVVLEOHH[SODQDWLRQIRUWKLVLQFUHDVHPLJKWEHWKDWPRUHDWWHQWLRQKDV EHHQSDLGWRVXSSOHPHQWVDQGQXWULWLRQLQFRPPHUFLDOVDQGRUWKHLQFUHDVHGVXSSO\RI VXSSOHPHQWVLQIRRGVWRUHV,QIOXRUVXSSOHPHQWVZHUHXVHGPRVWRIWHQ 

(73)  VXSSOHPHQWVZLWKYLWDPLQ$DQG'DQGPXOWLSOHYLWDPLQPLQHUDOVXSSOHPHQWVZHUHXVHGE\ RIWKHSHRSOHDYLWDPLQ&VXSSOHPHQWZDVXVHGE\DQGJDUOLFYLWDPLQ% FDOFLXP DQGEUHZHU¶V\HDVWVXSSOHPHQWVZHUHXVHGE\OHVVWKDQRIWKHSRSXODWLRQ $OVRDVLJQLILFDQWUHODWLRQVKLSH[LVWVEHWZHHQDJHDQGVXSSOHPHQWXVHRIWKHFKLOGUHQ DJHG \HDUVXVHVVXSSOHPHQWVDGROHVFHQWVXVHVXSSOHPHQWVOHVVRIWHQ 

(74) ZKHUHDVWKH SURSRUWLRQLQFUHDVHVZLWKDJHWRLQWKHJURXSDJHG7KHKLJKXVDJHDPRQJWKH \RXQJFKLOGUHQFDQEHH[SODLQHGE\WKHFXUUHQWUHFRPPHQGDWLRQVIRUWKHXVHRIIOXRUDQG YLWDPLQ'WDEOHWVIRUWKLVJURXS$OVRDVLJQLILFDQWUHODWLRQVKLSH[LVWVEHWZHHQVH[DQG VXSSOHPHQWXVHZRPHQXVHVXSSOHPHQWVPRUHRIWHQWKDQPHQ DQG UHVSHFWLYHO\

(75) ,QJHQHUDOSHRSOHLQWKHZHVWHUQUHJLRQVRIWKH1HWKHUODQGVXVHVXSSOHPHQWV PRUH RIWHQWKDQSHRSOHOLYLQJLQWKHVRXWKHUQSDUWV DQGUHVSHFWLYHO\

(76)  +RZHYHUQRUHODWLRQVKLSKDVEHHQIRXQGEHWZHHQXVHRIVXSSOHPHQWVDQGLQFRPHLQ7KH 1HWKHUODQGVZKLFKLVLQFRQWUDVWWRWKH86$ZKHUHWKHXVHRIVXSSOHPHQWVLQFUHDVHVZLWK LQFUHDVLQJLQFRPH 7KHHIIHFWVRIDJHVH[UHJLRQDOGLIIHUHQFHVDQGVRFLDOFODVVRQVXSSOHPHQWXVHDUHDOVRIRXQG LQRWKHUFRXQWULHV 86$(QJODQG$XVWUDOLD

(77)  7KHUHVXOWVRIWKHXVHRIVXSSOHPHQWVLQ WKH WKLUGQDWLRQDO)RRG&RQVXPSWLRQ6XUYH\ 

(78) VKRZVRPHGLIIHUHQFHVFRPSDUHGWR 7KHXVHRIYLWDPLQµ$DQG'¶DQGIOXRUVXSSOHPHQWVLVGHFUHDVHGDVFRPSDUHGWR FRPSDUHGWRDQGFRPSDUHGWRLQUHVSHFWLYHO\

(79) 7KHXVHRI YLWDPLQ&VXSSOHPHQWVLVQHDUO\WKHVDPH FRPSDUHGWRLQ

(80) 0XOWLYLWDPLQ VXSSOHPHQWV DQGWKHFDWHJRU\µPLVFHOODQHRXVVXSSOHPHQWV¶ IRUH[DPSOHJDUOLFFDOFLXPDQG EUHZHU¶V \HDVWVXSSOHPHQWV

(81) DUHXVHGPRUHRIWHQ FRPSDUHGWRLQDQG FRPSDUHGWRLQUHVSHFWLYHO\

(82)  . . . 6XSSOHPHQWXVDJHLQWKH86$ 9LWDPLQVXSSOHPHQWXVDJHDPRQJWKH86SRSXODWLRQKDVLQFUHDVHGIURPRIWKH SRSXODWLRQLQWKHHDUO\VWRDQHVWLPDWHGLQ0XOWLSOHYLWDPLQPLQHUDO VXSSOHPHQWVDUHXVHGPRVWRIWHQ 

(83) DQGVLQJOHFRPSRQHQWVXSSOHPHQWVDUHXVHGOHVV RIWHQ YLWDPLQ$YLWDPLQ&DQGYLWDPLQ(

(84)  $OWKRXJKVHYHUDODGYHUVHHIIHFWVKDYHEHHQDVVRFLDWHGZLWKPHJDGRVHVRIDQWLR[LGDQW YLWDPLQVPRVWDUHVLQJOHFDVHUHSRUWVRUFDVHVHULHV .

(85) 5,90UHSRUW. SDJHRI. 7KHWKLUG1DWLRQDO)RRG&RQVXPSWLRQ6XUYH\LQ7KH1HWKHUODQGV 9RHGVHOFRQVXPSWLHSHLOLQJ 9&3

(86) 

(87) LQWDNHRIYLWDPLQVDQGPLQHUDOVIURPIRRG 7KHOHYHORILQWDNHRIYLWDPLQVPLQHUDOVDQGRWKHUFRPSRQHQWVIURPWKHQRUPDOGLHWLV REYLRXVO\DOVRLPSRUWDQWLQGHWHUPLQLQJWKHOHYHODWZKLFKDGYHUVHHIIHFWVRFFXULQ LQGLYLGXDOVZKRWDNHGLHWDU\VXSSOHPHQWV7KHUHIRUHVRPHJHQHUDOUHVXOWVRIWKHPRVWUHFHQW 1DWLRQDO)RRG6XUYH\LQWKH1HWKHUODQGV 

(88) ZLOOEHGLVFXVVHGKHUHEULHIO\ ZLWK UHVSHFW WRWKHLQWDNHRIYLWDPLQVDQGPLQHUDOVIURPIRRGSURGXFWV  YLWDPLQV 7KHLQWDNHRIYLWDPLQ%%&DQG(LVKLJKHUWKDQWKH5'$IRUDOODJHJURXSV7KHLQWDNH RI YLWDPLQ%LQDEVROXWHVHQVHLVDGHTXDWHEXWZKHQUHODWHGWRWKHSURWHLQLQWDNHHVSHFLDOO\ WKH \RXQJDJHJURXSVGRQ¶WPHHWWKH5'$$GROHVFHQWVKDYHDORZHUYLWDPLQ$LQWDNHWKDQ WKH UHFRPPHQGHGDOORZDQFH,QIDQWVDQGWKHHOGHUO\KDYHDKLJKHU GLHWDU\

(89) UHTXLUHPHQWIRU YLWDPLQ'EHFDXVHRIOHVVVXQH[SRVXUH)RUDOORWKHUDJHJURXSVWKHYLWDPLQ'LQWDNHLV VXIILFLHQW DWOHDVWWKH5'$

(90)   PLQHUDOV 7KHDYHUDJHLQWDNHRIFDOFLXPSKRVSKRUXVDQGPDJQHVLXPLVKLJKHUWKDQWKHUHFRPPHQGHG GDLO\DOORZDQFH 5'$

(91) 7KHLQWDNHRILURQLQDGROHVFHQWVDQGZRPHQLVORZHUWKDQWKH5'$ 7KLVLVDOVRWUXHIRUWKHLQWDNHRIFRSSHULQPHQDQGZRPHQDQGRIVHOHQLXPLQZRPHQ:LWK LQFUHDVLQJDJHWKHLQWDNHRIVHOHQLXPGHFUHDVHV7KHLQWDNHRI]LQFLQDGROHVFHQWVLVDOVR ORZHUWKDQWKH5'$ . .

(92) SDJHRI. 5,90UHSRUW.  &RQFOXVLRQV ,QWKLVUHSRUWDQRYHUYLHZRIDFWLYHFRPSRQHQWVKDVEHHQPDGHZKLFKDUHIUHTXHQWO\IRXQGLQ IRRG VXSSOHPHQWV7KHOHVVZHOOGHILQHGSUHSDUDWLRQVIURPKHUEDORULJLQDQGWKHDPLQRDFLG FRQWDLQLQJVXSSOHPHQWVDUHQRWWDNHQLQWRDFFRXQW %DVHGRQWKHGLIIHUHQFHEHWZHHQWKH5'$DQGSRVVLEOHWR[LFHIIHFWVDJHQHUDOGLVWLQFWLRQLQ WKHDFWLYHFRPSRQHQWVDFFRUGLQJWR0DUNV  KDVEHHQPDGH6RPHFRPSRQHQWVDUHUHODWLYHO\ VDIH DWDKLJKLQWDNH !WLPHVWKH5'$FDWHJRU\$

(93) EXWRWKHUVVKRZWR[LFHIIHFWVDWDQ LQWDNHORZHUWKDQWLPHVWKH5'$ FDWHJRU\%

(94)  %DVHGRQWKHGDWDLQWKLVUHSRUWZHKDYHFODVVLILHGWKHIROORZLQJFRPSRXQGVLQFDWHJRU\$ YLWDPLQ%  YLWDPLQ%  YLWDPLQ%  YLWDPLQ%  YLWDPLQ%  IRODWHYLWDPLQ%  YLWDPLQ. FREDOWLRGLQHIOXRULGHFKURPLXPPRO\EGHQXPRPHJDIDWW\DFLGVDQGRPHJDIDWW\ DFLGV ,QFDWHJRU\%WKHIROORZLQJFRPSRXQGVKDYHEHHQSXWEHFDXVHRIWKHLUUHSRUWHGDGYHUVH HIIHFWVRUWR[LFLW\RUEHFDXVHRIDQLQFUHDVHGULVNDWKLJKLQWDNHVIRUULVNJURXSVWKHYLWDPLQV $&'(IRODWHFDOFLXP]LQFVHOHQLXPLURQDQGbFDURWHQH$WSUHVHQWPRVWZRUULVRPH LV WKHKLJKLQWDNHRILURQ DQGRUYLWDPLQ&

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

(96) WUDFHHOHPHQWV FKURPLXPVHOHQLXPFRSSHUFREDOW

(97) DQGDQWLR[LGDQWV YLWDPLQ&(FDURWHQRLGV

(98)  %HVLGHVSUREOHPVZLWKRYHUGRVHFHUWDLQHIIHFWVRIQRUPDORUVRPHZKDWHOHYDWHGGRVHVRI YLWDPLQVDQGRUPLQHUDOVFDQEHH[SHFWHGLQFHUWDLQJURXSVDWULVN 7KHVHULVNJURXSVLQFOXGHSUHJQDQWZRPHQIRUYLWDPLQ$FKLOGUHQIRUYLWDPLQ$DQG'.

(99) 5,90UHSRUW. SDJHRI. IRODWHIRU% GHILFLHQWSHRSOHLQGLYLGXDOVZLWKKHPRFKURPDWRVLVIRULURQDQGYLWDPLQ& SDWLHQWV UHFHLYLQJDQWLFRDJXODQWWKHUDS\IRUYLWDPLQ(SDWLHQWVZLWKFKURQLFUHQDOIDLOXUHDQG NLGQH\ VWRQHVIRUFDOFLXPDQGVPRNHUVIRUbFDURWHQH :LWKUHVSHFWWRWKHGRVHRIFRPSRQHQWVLQVXSSOHPHQWVLQWKH1HWKHUODQGVQRDODUPLQJKLJK OHYHOV KDYHEHHQIRXQG . ,QFRQFOXVLRQYLWDPLQ$DQG']LQFDQGVHOHQLXPDUHWR[LFDWUHODWLYHO\ORZLQWDNHVDOVRIRU KHDOWK\SHUVRQV6SHFLDOULVNJURXSVFDQEHLGHQWLILHGIRULURQYLWDPLQ&DQG(IRODWH FDOFLXPDQG‰FDURWHQH7KHVDIHW\RIWKHKRUPRQHVPHODWRQLQDQG'+($ DQG GHK\GURHSLDQGURVWHURQH

(100) KDVQRWEHHQLQYHVWLJDWHGWKRURXJKO\VRVSHFLDOFDUHVKRXOGEH WDNHQ ZLWKWKHXVHRIWKHVHFRPSRXQGV0RUHUHVHDUFKDQGDWWHQWLRQLVQHHGHGWRJHW TXDQWLWLYHGDWDRQWKHLQWDNHRIWKHPHQWLRQHGFRPSRQHQWVLQWKHVHULVNJURXSVDQGWKHKHDOWK FRQVHTXHQFHVIRUWKHP.

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

(103)  6WHZDUW0/0F'RQDOG-7/HY\$66FKXFNHU5(+HQGHUVRQ'39LWDPLQPLQHUDOVXSSOHPHQWXVHD WHOHSKRQHVXUYH\RIDGXOWVLQWKH8QLWHG6WDWHV-$P'LHW$VVRF 

(104)  'RUDQW(YDQGHQ%UDQGW3$+DPVWUD$0)HHQVWUD0+%DXVFK*ROGERKP5$>8WLOL]DWLRQRIIRRG VXSSOHPHQWVLQ7KH1HWKHUODQGV@*HEUXLNYDQYRHGLQJVVXSSOHPHQWHQLQ1HGHUODQG1HG7LMGVFKU*HQHHVNG  

(105)  6OHVLQVNL0-6XEDU$).DKOH//7UHQGVLQXVHRIYLWDPLQDQGPLQHUDOVXSSOHPHQWVLQWKH8QLWHG6WDWHWKH DQG1DWLRQDO+HDOWK,QWHUYLHZ6XUYH\V-$P'LHW$VVRF 

(106)  :RUVOH\$&UDZIRUG'$XVWUDOLDQGLHWDU\VXSSOHPHQWDWLRQSUDFWLFHV+HDOWKDQGGLHWDU\VXSSOHPHQWV0HG - $XVW 

(107)  *UHJRU\-)RVWHU.7\OHU+HWDO7KHGLHWDU\DQGQXWULWLRQDOVXUYH\RI%ULWLVKDGXOWV/RQGRQ+602  9RHGLQJVFHQWUXP=RHHW1HGHUODQG5HVXOWDWHQYDQGH9RHGVHOFRQVXPSWLHSHLOLQJ'HQ+DDJ 9RHGLQJVFHQWUXP.

(108) 5,90UHSRUW. SDJHRI. 0H\HUV'*0DOROH\3$:HHNV'6DIHW\RIDQWLR[LGDQWYLWDPLQV>VHHFRPPHQWV@$UFK,QWHUQ0HG  

(109)  %UHHGYHOG%&+XOVKRI.)$0+RHJRHGYRHGWGHJHPLGGHOGH1HGHUODQGHU]LFK"9RHGLQJ1X  

(110)  ,QWHUQDWLRQDO8QLRQRI1XWULWLRQDO6FLHQFHV*HQHULFGHVFULSWRUVDQGWULYLDOQDPHVIRUYLWDPLQVDQGUHODWHG FRPSRXQGVUHFRPPHQGDWLRQV 

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

(112)  'HYRHGLQJVPLGGHOHQJLGVHG+DDUOHPGH7RRUWV &RPEV*)7KH9LWDPLQVIXQGDPHQWDODVSHFWVLQQXWULWLRQDQGKHDOWK6DQ'LHJR$FDGHPLF3UHVV /LQGHU0&/LQGHU0&HGLWRUV1XWULWLRQDO%LRFKHPLVWU\DQG0HWDEROLVPQGHG1<(OVHYLHU 1XWULWLRQDQGPHWDEROLVPRIYLWDPLQVS %DVVOHU.+6WDKHOLQ*%UXEDFKHU*HGLWRUV(OHYDWHGGRVDJHVRIYLWDPLQV1<+DQV+XEHU3XEOLVKHUV 8VHDQGDEXVHRIKLJKGRVDJHVRIYLWDPLQ% GH%UHH$YDQ'XVVHOGRUS0%URXZHU,$YDQKHW+RI.+6WHHJHUV7KHXQLVVHQ53)RODWHLQWDNHLQ (XURSHUHFRPPHQGHGDFWXDODQGGHVLUHGLQWDNH(XU-&OLQ1XWU 

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

(114)  

(115)  'DKOLW]0$OYDUH]%9LJQDX-(QJOLVK-3DUNHV-'HWDO'HOD\HGVOHHSSKDVHV\QGURPHUHVSRQVHWR PHODWRQLQ/DQFHW %XVV1(7HPEH($3UHQGHUJDVW%'5HQZLFN$**HRUJH&)7KHWHUDWRJHQLFPHWDEROLWHVRIYLWDPLQ$ LQZRPHQIROORZLQJVXSSOHPHQWVDQGOLYHU+XP([S7R[LFRO 

(116) .

(117) SDJHRI. 5,90UHSRUW. +HDOWK&RXQFLO)RRGDQG1XWULWLRQ&RXQFLO9LWDPLQ$DQGWHUDWRJHQLFLW\7KH+DJXH*H]RQGKHLGVUDDG  :DUHQZHWUHJHOLQJ9ULMVWHOOLQJ9LWDPLQHSUHSDUDWHQ6WDDWVFRXUDQW PDDUW

(118) YDQ3RSSHO*YDQGHQ%HUJ+9LWDPLQVDQGFDQFHU&DQFHU/HWW :DOWHU36XSUDSK\VLRORJLFDOGRVDJHVRIYLWDPLQVDQGWKHLULPSOLFDWLRQVLQPDQ([SHULHQWLD  .DSSXV+'LSORFN$77ROHUDQFHDQGVDIHW\RIYLWDPLQ(DWR[LFRORJLFDOSRVLWLRQUHSRUW)UHH5DGLF%LRO 0HG :HEHU3%HQGLFK$0DFKOLQ/-9LWDPLQ(DQGKXPDQKHDOWKUDWLRQDOHIRUGHWHUPLQLQJUHFRPPHQGHG LQWDNHOHYHOV1XWULWLRQ 

(119)  +DWFKFRFN-1%HQGLFK$%XWWHUZRUWK&(HGLWRUV0LFURQXWULHQWVLQKHDOWKDQGGLVHDVHSUHYHQWLRQ1< 0DUFHO'HNNHU6DIHW\RIYLWDPLQDQGPLQHUDOVXSSOHPHQWV )UHHGPDQ-()DUKDW-+/RVFDO]R-.HDQ\-)$OSKDWRFRSKHUROLQKLELWVDJJUHJDWLRQRIKXPDQSODWHOHWVE\ D SURWHLQNLQDVH&GHSHQGHQWPHFKDQLVP&LUFXODWLRQ .LWDJDZD00LQR0(IIHFWVRIHOHYDWHGGDOSKD 555

(120) WRFRSKHUROGRVDJHLQPDQ-1XWU6FL9LWDPLQRO  &RPVWRFN*:%XVK7/+HO]ORXHU.6HUXPUHWLQROEHWDFDURWHQHYLWDPLQ(DQGVHOHQLXPDVUHODWHGWR VXEVHTXHQWFDQFHURIVSHFLILFVLWHV$P-(SLGHPLRO 3DVVPRUH5(DVWZRRG0$+XPDQQXWULWLRQDQGGLHWHWLFVWKHG1<&KXUFKLOO/LYLQJVWRQH %RQHPLQHUDOVS 2SWLPDOFDOFLXPLQWDNH1,+&RQVHQV6WDWHPHQW 

(121)  *X\WRQ$&7H[WERRNRIPHGLFDOSK\VLRORJ\WKHG3KLODGHOSKLD:%6DXQGHUV&RPSDQ\ &KDQGUD5.([FHVVLQWDNHRI]LQFLPSDLUVLPPXQHUHVSRQV-$P0HG$VVRF )HVWD0'$QGHUVRQ+/'RZG\53(IIHFWRQFRSSHUH[FUHWLRQDQGUHWHQWLRQLQPHQ$P-&OLQ1XWU  +HDOWK&RXQFLORIWKH1HWKHUODQGV&RPPLWWHHRQWKH5LVNHYDOXDWLRQRI6XEVWDQFHV=LQF5LMVZLMN+HDOWK &RXQFLORIWKH1HWKHUODQGV 0LOQH'%&RSSHULQWDNHDQGDVVHVVPHQWRIFRSSHUVWDWXV$P-&OLQ1XWU VXSSO

(122)  *UDDIGH&*URRW&3*06HLGHOO-&HWDO9RHGLQJLQ1HGHUODQGJH]RQGKHLGJURHLHQRQWZLNNHOLQJ +RXWHQ%RKQ6WDIOHX9DQ/RJKXP *UHJHU-/)RRGVXSSOHPHQWVDQGIRUWLILHGIRRGVVFLHQWLILFHYDOXDWLRQVLQUHJDUGWRWR[LFRORJ\DQGQXWULHQW ELRDYDLODELOLW\-$P'LHW$VVRF 

(123)  <DQJ*4;LD<06WXGLHVRQKXPDQGLHWDU\UHTXLUHPHQWVDQGVDIHUDQJHRIGLHWDU\LQWDNHVRIVHOHQLXPLQ &KLQDDQGWKHLUDSSOLFDWLRQLQWKHSUHYHQWLRQRIUHODWHGHQGHPLFGLVHDVHV%LRPHG(QYLURQ6FL 

(124)   9RHGLQJVFHQWUXP9RRUOLFKWLQJVEXUHDXYRRUGH9RHGLQJ(HQJH]RQGHNLMNRSYLWDPLQHVHQPLQHUDOHQ(GH .

(125) 5,90UHSRUW. SDJHRI. +RGJH+&6WDKO:6LPRQGV-+HGLWRUV)OXRULQHFKHPLVWU\1<$FDGHPLF3UHVV%LRORJLFDO SURSHUWLHVRILQRUJDQLFIOXRULGHVS 3KLSSV.)OXRULGHDQGERQHKHDOWK-3XEOLF+HDOWK'HQW 

(126)  6KLOV0(2OVRQ-$DQG6KLNH0HGLWRUV0RGHUQQXWULWLRQLQKHDOWKDQGGLVHDVHWKHG3KLODGHOSKLD/HD )HELJHU 0HUW]:&KURPLXPLQKXPDQQXWULWLRQDUHYLHZ>VHHFRPPHQWV@-1XWU 

(127)  7XUQOXQG-5.H\HV:53IHLIIHU*/$QNH00HLVVQHU'0LOOV&)HGLWRUV7UDFHHOHPHQWVLQPDQDQG DQLPDOV*HUVGRUI0HGLD7RXULVWLN$VWDEOHLVRWRSHVWXG\RIWKHGLHWDU\PRO\EGHQXPUHTXLUHPHQWRI \RXQJPHQS -RQNHUV&9LVVHU*:LSNLQN$.OLQLVFKH9RHGLQJ+DDUOHPGH7RRUW 5HLOO\&6HOHQLXPDQHZHQWUDQWLQWRWKHIXQFWLRQDOIRRGDUHQD7UHQGV)RRG6FL7HFKQ 

(128)  0XOOHU+>'DLO\LQWDNHRIFDURWHQRLGV FDURWHQHVDQG[DQWKRSK\OOV

(129) IURPWRWDOGLHWDQGWKHFDURWHQRLG FRQWHQWRIVHOHFWHGYHJHWDEOHVDQGIXLW@'LHWDJOLFKH$XIQDKPHYRQ&DURWLQRLGHQ &DURWLQHXQG;DQWKRSK\OOH

(130) DXV*HVDPWQDKUXQJVSUREHQXQGGLH&DURWLQRLGJHKDOWHDXVJHZDKOWHU*HPXVHXQG2EVWDUWHQ=(UQDKUXQJVZLVV  

(131)  *XDUGLROD/07R[LFRORJ\RIPHODWRQLQ-%LRO5K\WKPV 

(132)  $QRQ\PRXV'HK\GURHSLDQGURVWHURQH '+($

(133) 0HG/HWW'UXJV7KHU 0RUDOHV$UOHQH-1RODQ-RKQ-1HOVRQ-HUDOG&<HQ6DPXHO6(IIHFWVRIUHSODFHPHQWGRVHRI GHK\GURHSLDQGURVWHURQHLQPHQDQGZRPHQRIDGYDQFLQJDJH-&OLQ(QGRFULQRO0HWDE 

(134)  1HVWOHU-RKQ($GYDQFHVLQXQGHUVWDQGLQJWKHUHJXODWLRQDQGELRORJLFDFWLRQVRIGHK\GURHSLDQGURVWHURQH &XUU2SLQ(QGRFULQRO'LDEHWHV )RRGDQG$JULFXOWXUH2UJDQL]DWLRQ:RUOG+HDOWK2UJDQL]DWLRQ)DWLQKXPDQQXWULWLRQ5HSRUWRIDQH[SHUW FRQVXOWDWLRQ5RPH3XEOLFDWLRQV'LYLVLRQ)$2 6WHLQPHW].$3RWWHU-'9HJHWDEOHVIUXLWDQGFDQFHU,,0HFKDQLVPV&DQFHU&DXVHVDQG&RQWURO  

(135)  GH9ULHV-+-DQVVHQ3/+ROOPDQ3&YDQ6WDYHUHQ:$.DWDQ0%&RQVXPSWLRQRITXHUFHWLQDQG NDHPSIHUROLQIUHHOLYLQJVXEMHFWVHDWLQJDYDULHW\RIGLHWV&DQFHU/HWW 

(136)  +HUWRJ0*+ROOPDQ3&.DWDQ0%.URPKRXW',QWDNHRISRWHQWLDOO\DQWLFDUFLQRJHQLFIODYRQRLGVDQG WKHLUGHWHUPLQDQWVLQDGXOWVLQ7KH1HWKHUODQGV1XWU&DQFHU 

(137)  &RQTXHU-$0DLDQL*$]]LQL(5DJX]]LQL$+ROXE%-6XSSOHPHQWDWLRQZLWKTXHUFHWLQPDUNHGO\ LQFUHDVHVSODVPDTXHUFHWLQFRQFHQWUDWLRQZLWKRXWHIIHFWRQVHOHFWHGULVNIDFWRUVIRUKHDUWGLVHDVHLQKHDOWK\ VXEMHFWV-1XWU 

(138)  :HEHU&%\VWHG$+RHOPHU*7KHFRHQ]\PH4FRQWHQWRIWKHDYHUDJH'DQLVKGLHW,QW-9LW1XWU5HV  

(139)  *HUVWHU+7KHSRWHQWLDOUROHRIO\FRSHQHIRUKXPDQKHDOWK-$P&ROO1XWU 

(140)  6WDKO:6LHV+/\FRSHQHDELRORJLFDOO\LPSRUWDQWFDURWHQRLGIRUKXPDQV"$UFK%LRFKHP%LRSK\V  

(141)  %OXPEHUJ-%&RQVLGHUDWLRQVRIWKHVFLHQWLILFVXEVWDQWLDWLRQIRUDQWLR[LGDQWYLWDPLQVDQGEHWDFDURWHQHLQ GLVHDVHSUHYHQWLRQ$P-&OLQ1XWU 6XSSO

(142) 66.

(143) SDJHRI. 5,90UHSRUW. 5RFN&/-DFRE5$%RZHQ3(8SGDWHRQWKHELRORJLFDOFKDUDFWHULVWLFVRIWKHDQWLR[LGDQWPLFURQXWULHQWV YLWDPLQ&YLWDPLQ(DQGWKHFDURWHQRLGV>VHHFRPPHQWV@-$P'LHW$VVRF 

(144)  5LFKDUGVRQ'37KHDGGLWLRQRIQXWULHQWVWRIRRGV,Q6\PSRVLXPRQµ)RRGLQGXVWU\QXWULWLRQDQGSXEOLF KHDOWK¶3URFHHGLQJVRIWKH1XWULWLRQ6RFLHW\ /HYLQH05XPVH\6&'DUXZDOD53DUN-%:DQJ<&ULWHULDDQGUHFRPPHQGDWLRQVIRUYLWDPLQ&LQWDNH -$0$ -RKQVWRQ&6%LRPDUNHUVIRUHVWDEOLVKLQJDWROHUDEOHXSSHULQWDNHOHYHOIRUYLWDPLQ&1XWULWLRQ5HYLHZV  

(145)  9LHWK59LWDPLQ'VXSSOHPHQWDWLRQK\GUR[\YLWDPLQ'FRQFHQWUDWLRQVDQGVDIHW\$P-&OLQ1XWU  6FKPDQQ.(OVHQKDQV%0lXUHU$,URQVXSSOHPHQWDWLRQ-7UDFH(OHPHQWV0HG%LRO 5RVD)::LON$/.HOV\)27HUDWRJHQXSGDWHYLWDPLQ$FRQJHQHUV7HUDWRORJ\ 

(146)  )RRGDQG1XWULWLRQ&RXQFLO5HFRPPHQGHGGLHWDU\DOORZDQFHVLQWKH1HWKHUODQGVVHFRQGUHYLVHG HGLWLRQ%XUHDXIRU)RRGDQG1XWULWLRQ(GXFDWLRQ7KH+DJXH 9RHGLQJVUDDG$GYLHVLQ]DNHKHWWRHYRHJHQYDQHVVHQWLsOHYRHGLQJVVWRIIHQDDQYRHGLQJVPLGGHOHQ7KH +DJXH +HUPXV5--6HYHUV$+.OLQLVFKHEHWHNHQLVYDQH[WUDYLWDPLQHQXLWVXSSOHPHQWHQHQYHUULMNWH YRHGLQJVPLGGHOHQ1HG7LMGVFKU*HQHHVNG 

(147)  %H]DUG-%ORQG-3%HUQDUG$&ORXHW37KHPHWDEROLVPDQGDYDLODELOLW\RIHVVHQWLDO IDWW\DFLGVLQDQLPDODQGKXPDQWLVVXHV5HSURG1XWU'HY 

(148) .

(149) 5,90UHSRUW. SDJHRI. 5HIHUHQFHV,, ,QIRUPDWLRQDERXWWKHFRPSRVLWLRQRIWKHVXSSOHPHQWVGHULYHGIURPWKH,QWHUQHWSDJHV DOSKDEHWLFDORUGHU

(150) DOOYLVLWHGEHWZHHQ'HFHPEHU DQG'HFHPEHU  

(151) WK. $OOHUJ\5HVHDUFK*URXS %RG\:LVH +HUEDO'DYH ,36 ,PPHGLDWH 3KDUPDFHXWLFDO6HUYLFHV

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

(153) SDJHRI. $SSHQGLFHV. 5,90UHSRUW.

(154) 5,90UHSRUW. SDJHRI. ([SODQDWLRQRIWKHWDEOHVLQDSSHQGLFHV,9,, 1RPHQFODWXUHWKHQRPHQFODWXUHSROLF\LVEDVHGRQµ*HQHULFGHVFULSWRUVDQGWULYLDOQDPHV IRU YLWDPLQVDQGUHODWHGFRPSRXQGUHFRPPHQGDWLRQV 

(155) ¶E\WKH,QWHUQDWLRQDO8QLRQRI 1XWULWLRQDO6FLHQFHV&RPPLWWHHRQ1RPHQFODWXUH  ZKLFKLVFRQVLVWHQWZLWKWKH 5HFRPPHQGDWLRQVRIWKH&RPPLVVLRQRQ%LRFKHPLFDO1RPHQFODWXUH,83$&,8%DQGWKH FRPPLWWHHRQ1RPHQFODWXUHRIWKH$PHULFDQ,QVWLWXWHRI1XWULWLRQ 2QWKHULJKWVLGHEHWZHHQSDUHQWKHVLVWKHZD\WKHFRPSRQHQWLVIRXQGLQVXSSOHPHQWVPRVW RIWHQ LVPHQWLRQHG7KHFXUVLYDWHGFRPSRQHQWLVWKHFRPSRQHQWDVGHVFULEHGLQµREVHUYHG GRVH LQVXSSOHPHQWV¶ VHHEHORZ

(156)  . 0LQLPXPWKLV LVWKHTXDQWLW\RIWKHQXWULHQWWKDWPXVWEHVXSSOLHGLQWKHGLHWLQRUGHUWR VDWLVI\WKHPHWDEROLFQHHGLWLQFOXGHVIDFWRUVDVVRFLDWHGZLWKGLJHVWLRQDEVRUSWLRQDQG FHOOXODUELRDYDLODELOLW\ . 5'$:KHQDYDLODEOHWKH'XWFKUHFRPPHQGHGGLHWDU\DOORZDQFHV 5'$

(157) DUHJLYHQ ,IQRW WKH $PHULFDQ5'$VDUHXVHG 5HFRPPHQGHG'LHWDU\$OORZDQFHV 5'$V

(158) DUHWKHOHYHOV RI LQWDNHRIHVVHQWLDOQXWULHQWVWKDWRQWKHEDVLVRIVFLHQWLILFNQRZOHGJHDUHMXGJHGE\WKH 1DWLRQDO+HDOWK&RXQFLO WKH1HWKHUODQGV

(159) RUWKH)RRGDQG1XWULWLRQ%RDUG 86$

(160) WREH DGHTXDWHWRPHHWWKHNQRZQQXWULWLRQDOQHHGVRISUDFWLFDOO\DOOKHDOWK\SHUVRQV PHDQ UHTXLUHPHQWOHYHOSOXVWZRWLPHVWKHVWDQGDUGGHYLDWLRQ

(161) :KHQNQRZQ5'$VIRUPHQ 0

(162) DQGZRPHQ )

(163) DUHJLYHQVHSDUDWHO\ 1RWH$WWKLVPRPHQWLQWKH86QHZGLHWDU\UHIHUHQFHLQWDNHV '5,V

(164) DUHEHLQJPDGHZKLFK DUHLQWHQGHGWRUHSODFHWKH5'$V 

(165) 7KH'5,VUHIOHFWDVKLIWLQHPSKDVLVIURP SUHYHQWLQJGHILFLHQF\WRGHFUHDVLQJWKHULVNRIFKURQLFGLVHDVHWKURXJKQXWULWLRQ,QVWHDGRID VLQJOHYDOXHWKH'5,VZLOOHQFRPSDVV  HVWLPDWHGDYHUDJHUHTXLUHPHQW ($5

(166) WKHLQWDNHWKDWPHHWVWKHHVWLPDWHGQXWULHQWQHHGRI  RIWKHLQGLYLGXDOVLQDVSHFLILFJURXS  UHFRPPHQGHGGDLO\DOORZDQFH 5'$

(167) WKHLQWDNHWKDWPHHWVWKHQXWULHQWQHHGRIDOPRVWDOO 

(168) RIWKHKHDOWK\LQGLYLGXDOVLQDVSHFLILFDJHDQGJHQGHUJURXS,ILQGLYLGXDOYDULDWLRQ LQ UHTXLUHPHQWVLVZHOOGHILQHGWKH5'$LVVHWDWVWDQGDUGGHYLDWLRQVDERYHWKH($5,I VXIILFLHQWGDWDDUHQRWDYDLODEOHWKH5'$LVVHWDW[($5  DGHTXDWHLQWDNH $,

(169) ZKHQVXIILFLHQWVFLHQWLILFHYLGHQFHLVQRWDYDLODEOHWRHVWLPDWHDQ DYHUDJHUHTXLUHPHQWDGHTXDWHLQWDNHVZLOOEHVHW  WROHUDEOHXSSHULQWDNHOHYHO 8/

(170) WKHPD[LPXPLQWDNHE\DQLQGLYLGXDOWKDWLVXQOLNHO\WR SRVH ULVNVRIDGYHUVHKHDOWKHIIHFWVLQDOPRVWDOOKHDOWK\LQGLYLGXDOVLQDVSHFLILHGJURXS . . 7R[LFLW\WKHH[DFWOHYHODWZKLFKSHUVRQVGHYHORSV\PSWRPVLQUHVSRQVHWRRYHUFRQVXPSWLRQ RI DFHUWDLQFRPSRXQGLVGLIILFXOWWRGHILQH7KHVL]HDQGDJHRILQGLYLGXDOVWKHGXUDWLRQRI WKH VXSSOHPHQWDWLRQSHULRGVDQGWKHTXDQWLW\DQGIRUPRIWKHFRPSRXQGVFRQVXPHGFDQ JUHDWO\DIIHFWVHQVLWLYLW\)RUFHUWDLQFRPSRQHQWVWKHOHYHORIWR[LFLW\LVKLJKO\VSHFXODWLYHRU.

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

(172) 5,90UHSRUW. SDJHRI. 2EVHUYHGGRVHLQVXSSOHPHQWV$OOWKHVXSSOHPHQWVDUHWDEOHWVRUFDSVXOHV )LUVWWKHEUDQGQDPHLVPHQWLRQHGIROORZHGE\WKHIDFWXUHU¶VQDPH LINQRZQ

(173) RUWKH VXSSOLHU¶VQDPHDQGWKH\HDURIVDOH7KHVXJJHVWHGGDLO\LQWDNHDFFRUGLQJWRWKH PDQXIDFWXUHULVLQGLFDWHGDQGWKHVHUYLQJVL]HLVWDEOHWFDSVXQOHVVPHQWLRQHGRWKHUZLVH HJ PJLQWDEOHWV

(174) 7KHVHOHFWLRQLVµDWUDQGRP¶WU\LQJWRJLYHDJRRGRYHUYLHZRIWKH DYDLODEOHTXDQWLWLHVDQGGRVHVDQGRIWKHVXJJHVWHGGRVHRIWKHPDQXIDFWXUHUV 0RVWRIWKHWLPHWKHFRPSRXQGLVDFRQVWLWXHQWRIDVXSSOHPHQWZLWKPRUHDFWLYH FRPSRQHQWV HJPXOWLYLWDPLQVXSSOHPHQW

(175) ,IWKHVXSSOHPHQWLVDVLQJOHFRPSRQHQW VXSSOHPHQWLWLVPDUNHGZLWKDQDVWHULVN IRUH[DPSOHPJYLWDPLQ&VXSSOHPHQW

(176) 'LHWDU\VRXUFHIRRG SURGXFWVRUFDWHJRULHVDUHPHQWLRQHGZKLFKDUHD UHODWLYHO\

(177) ULFK VRXUFH RIWKHFRPSRQHQW )XQFWLRQD JHQHUDOGHVFULSWLRQRIWKHHIIHFWRUIXQFWLRQLQWKHKXPDQERG\LVJLYHQ 'HILFLHQF\V\PSWRPVD EURDGGHVFULSWLRQRIHDUO\DQGRUODWHV\PSWRPVDUHOLVWHGZKLFKFDQ RFFXUZKHQWKHPLQLPXPUHTXLUHPHQWLVQRWUHDFKHG 1RWHZKHQQR UHFHQW

(178) LQIRUPDWLRQFRXOGEHIRXQGDERXWDQDVSHFWRIDFRPSRQHQWRUWKH DVSHFW GRHVQRWDSSO\IRUWKHFRPSRQHQWDK\SKHQLVXVHG.

(179) SDJHRI. 5,90UHSRUW. $SSHQGL[,:DWHUVROXEOHYLWDPLQV 7DEOHWKLDPLQ. WKLDPLQ IRUPHUO\NQRZQ DV YLWDPLQ%

(180) 0LQLPXP UHTXLUHPHQW. . 5HFRPPHQGHG GDLO\DOORZDQFH 5'$

(181) 7R[LFGRVH. 2EVHUYHGGRVH LQVXSSOHPHQWV 'LHWDU\VRXUFH )XQFWLRQ. 'HILFLHQF\ V\PSWRPV. WKLDPLQ+&O

(182)  PJ PJ —J0HJDMRXOH 0PJ )PJ QRWHUHTXLUHPHQWLVFRXSOHGWRHQHUJ\LQWDNH PHGLDQLQWDNHLQWKH86LVPJG7KHQLQHW\ILIWKSHUFHQWLOHRILQWDNH IURP ERWKIRRGDQGVXSSOHPHQWVLVDSSUR[LPDWHO\PJLQWKH86 WKHWR[LFSRWHQWLDORIWKLDPLQDSSHDUVWREHORZSDUWLFXODUO\ZKHQLWLV DGPLQLVWHUHGRUDOO\/DUJHSDUHQWHUDOGRVHV PJ

(183) DUHJHQHUDOO\ZHO WROHUDWHG2QO\DIWHUVHYHUDOLQMHFWLRQVE\GLIIHUHQWURXWHVRIGRVHV H[FHHGLQJE\PRUHWKDQIROGWKH5'$KDYHIHZLIDQ\WR[LF HIIHFWVDVFULEHGWRDOOHUJLFUHDFWLRQVEHHQUHSRUWHG   PJPJ .UXLGYDWHQ(WRVEUXLVWDEOHW

(184) PJ 6XSUDG\QFRPSOH[IRUWH5RFK

(185)  PJ 3KDUPDFKHPLH9LW%FRPSOH[IRUWH

(186) ZKROHZKHDWSURGXFWVSRUFQXWVOLYHUSRWDWRHV SOD\VDNH\UROHLQWKHERG\¶VPHWDEROLFF\FOHIRUJHQHUDWLQJHQHUJ\DLGVLQ WKH GLJHVWLRQRIFDUERK\GUDWHVHVVHQWLDOIRUWKHQRUPDOIXQFWLRQLQJRIWKH QHUYRXVV\VWHPPXVFOHVDQGKHDUWVWDELOL]HVWKHDSSHWLWHSURPRWHVJURZWK DQG JRRGPXVFOHWRQHIDFLOLWDWHVFDUERK\GUDWHPHWDEROLVPDQGPD\EH GHILFLHQWLQWKRVHRQDKLJKVXJDUGLHW PD\OHDGWRWKHORVVRIDSSHWLWHZHDNQHVVDQGIHHOLQJWLUHGLQVRPQLD PHQWDOGHSUHVVLRQUDSLGKHDUWEHDWFRQVWLSDWLRQKHDUWDQGJDVWURLQWHVWLQDO SUREOHPVLQH[WUHPHEHULEHUL . . . . .

(187) 5,90UHSRUW. 7DEOHULERIODYLQ. ULERIODYLQ IRUPHUO\NQRZQ DV YLWDPLQ% RU YLWDPLQ*

(188). SDJHRI. ULERIODYLQ

(189). . 0LQLPXP UHTXLUHPHQW 5HFRPPHQGHG GDLO\DOORZDQFH 5'$

(190) 7R[LFGRVH. 2EVHUYHGGRVH LQVXSSOHPHQWV 'LHWDU\VRXUFH )XQFWLRQ. 'HILFLHQF\ V\PSWRPV.  PJ. . 0PJ )PJ QRWHUHTXLUHPHQWLVFRXSOHGWRHQHUJ\LQWDNH KLJKRUDOGRVDJHVRIULERIODYLQDUHQRWWR[LFSUREDEO\GXHWRWKHUHODWLYHO\ SRRU DEVRUSWLRQDWKLJKLQWDNHOHYHOV1RDGYHUVHHIIHFWVLQKXPDQVKDYH EHHQUHSRUWHG6WXGLHVZLWKDQLPDOVLQGLFDWHWKDWGRVDJHVDVJUHDWDV WLPHVDOORZDQFHOHYHOVKDYHQHJOLJLEOHULVNVRIWR[LFLW\ PJ 201,3/(;(VVHQWLDO2UJDQLFV

(191)  PJLQWDEO 790/LIH3OXV

(192)  PJLQWDEO 0XOWL)RXU2UWKLFD

(193)  OLYHUPLONFKHHVHHJJVJUHHQYHJHWDEOHV QHFHVVDU\IRUFDUERK\GUDWHIDWDQGSURWHLQPHWDEROLVPDOVRLQWKH IRUPDWLRQRIDQWLERGLHVDQGUHGEORRGFHOOVPDLQWDLQVFHOOUHVSLUDWLRQ QHFHVVDU\IRUWKHPDLQWHQDQFHRIJRRGYLVLRQVNLQQDLOVDQGKDLUDFWV SDUWLFXODUO\FORVHO\ZLWKYLWDPLQV%DQG%DQGVHOHQLXP EXUQLQJ RUJULWW\H\HVVRUHWRQJXHFDWDUDFWVGXOORURLO\KDLUHF]HPDRU GHUPDWLWLVVSOLWQDLOVFUDFNHGOLSV .

(194) SDJHRI. 5,90UHSRUW. 7DEOHQLDFLQ. QLDFLQ IRUPHUO\NQRZQ DV YLWDPLQ%

(195) 0LQLPXP UHTXLUHPHQW 5HFRPPHQGHG GDLO\DOORZDQFH 5'$

(196) 7R[LFGRVH . 2EVHUYHGGRVH LQVXSSOHPHQWV 'LHWDU\VRXUFH )XQFWLRQ 'HILFLHQF\ V\PSWRPV. QLFRWLQDPLGH

(197)  PJ 86$

(198)  QRGXWFKUHFRPPHQGDWLRQV .  PJ 86$

(199)  QRGXWFKUHFRPPHQGDWLRQV . LQKXPDQVKLJKGRVDJHV JGD\

(200) RIQLFRWLQLFDFLG SURWHLQERXQGIRUP RI QLDFLQPDLQO\LQSODQWV

(201) FDXVHYDVRGLODWDWLRQLWFKLQJQDXVHDYRPLWLQJ DQG KHDGDFKHVZKHUHDVQLFRWLQDPLGH QLFRWLQLFDFLGDPLGHDQLPDOWLVVXHV

(202) RQO\ UDUHO\SURGXFHVWKHVHUHDFWLRQV1LFRWLQDPLGHGRVDJHVRIWLPHV 5'$V PJPJ

(203) FDQEHFRQVLGHUHGVDIHIRUPRVWSHRSOH $YDLODEOHLQIRUPDWLRQRQWKHWROHUDQFHRIDQLPDOVIRUQLDFLQLVVFDQWEXW VXJJHVWWKDWGDLO\GRVHVJUHDWHUWKDQPJQLFRWLQLFDFLGHTXLYDOHQWV SHU NJERG\ZHLJKWFDQEHWR[LF  JIRUWKHDYHUDJHSHUVRQ

(204)   PJ .UXLGYDWPXOWLYLWDPLQV

(205)  PJLQWDEO 1XWUD6RXUFH9LWDPLQ3RZHU&RPSDQ\

(206)  PJ 6XSHU%FRPSOH[9LWDPLQ3RZHU&RPSDQ\

(207) PJ 8OWUD3RWHQF\0XOWLSOH9LWDPLQ3RZHU&RPSDQ\

(208)  PHDWHJJVILVKPLONZKROHJUDLQV SURPRWHVWKHIXQFWLRQRIWKHFHQWUDOQHUYRXVV\VWHPDQGRIWKHGLJHVWLYH V\VWHP1HHGHGIRUWKHHQHUJ\SURGXFWLRQE\FHOOV SHOODJUDJDVWURLQWHVWLQDOGLVWXUEDQFHVLQVRPQLDVNLQGLVRUGHUVORVVRI DSSHWLWHPXVFXODUZHDNQHVV . .

(209) 5,90UHSRUW. SDJHRI. 7DEOHSDQWRWKHQLFDFLG. SDQWRWKHQLFDFLG 0LQLPXP UHTXLUHPHQW 5HFRPPHQGHG GDLO\DOORZDQFH 5'$

(210) 7R[LFGRVH. GFDOFLXPSDQWKRWKHQDWH

(211).  PJ 86$

(212)  QRGXWFKUHFRPPHQGDWLRQV . PJ 86$

(213)  QRGXWFKUHFRPPHQGDWLRQV SURGXFHG E\LQWHVWLQDOPLFURRUJDQLVPVGHILFLHQFLHVLQKXPDQVQRWNQRZQ . JHQHUDOO\UHJDUGHGDVEHLQJQRQWR[LFEXWDIHZUHSRUWVLQGLFDWHGLDUUKHD RFFXUULQJLQKXPDQVFRQVXPLQJJRIWKLVYLWDPLQSHUGD\ EXWLW VHHPVVDIHIRUKXPDQVDWGRVDJHVRIDWOHDVWWLPHV5'$  PJ

(214)  7KHUHLVQRWVXIILFLHQWVFLHQWLILFGDWDWRVHWDWROHUDEOHXSSHULQWDNH OHYHOIRUSDQWRWKHQLFDFLG  PJ 6XSHU9LWH9LWDPLQ3RZHU

(215) PJ 8OWUD3RWHQF\0XOWLSOH9LWDPLQ3RZHU&RPSDQ\

(216)  PJ 3DQWKRWHQLF$FLG/LIH([WHQVLRQ3URGXFWV

(217)   OLYHUPLONPHDWVHJJVZKROHJUDLQVILVKYHJHWDEOHV SDQWRWKHQLFDFLGPDLQO\LVLQFRUSRUDWHGLQWKHERG\LQWRFRHQ]\PH$ ZKLFK KDVPDQ\PHWDEROLFUROHVLQWKHFHOOV)RUH[DPSOHLWLVHVVHQWLDOWR WKH V\QWKHVLVRIIDWW\DFLGVDQGPHPEUDQHSKRVSKROLSLGVDVZHOODVWRWKH R[LGDWLYHGHJUDGDWLRQRIIDWW\DFLGVDQGDPLQRDFLGV VNLQ DEQRUPDOLWLHVUHWDUGHGJURZWKGLJHVWLYHGLVWXUEDQFHVVWRPDFKVWUHVV PXVFOHFUDPSV . . 2EVHUYHGGRVH LQVXSSOHPHQWV 'LHWDU\VRXUFH )XQFWLRQ. 'HILFLHQF\ V\PSWRPV. . .

(218) SDJHRI. 7DEOHYLWDPLQ%. YLWDPLQ%. 0LQLPXP UHTXLUHPHQW 5HFRPPHQGHG GDLO\DOORZDQFH 5'$

(219) 7R[LFGRVH . 5,90UHSRUW. S\ULGR[LQH+&/

(220).  PJ PJ IHPDOHV

(221) 0PJ )PJ . . WKHDFXWHWR[LFLW\LVYHU\ORZ JNJLVWROHUDWHGZHOO

(222) EXWWR[LFLW\PD\ RFFXUZLWKFKURQLFGDLO\GRVHVRIPJRUPRUHDQGLWVKRXOGDOZD\V EH XQGHUPHGLFDOVXSHUYLVLRQ . GDLO\GRVDJHVRIPJYLWDPLQ%KDYHEHHQXVHGIRUKXPDQV WUHDWPHQW RI SUHPHQVWUXDOWHQVLRQLQZRPHQ

(223) IRUSHULRGVRIVHYHUDOPRQWKVZLWKRXW VLJQLILFDQWDGYHUVHHIIHFWV/DUJHUGRVDJHV PJWRJSHUGD\

(224) KDYH SURGXFHGUHYHUVLEOHQHXURSDWKLHVDIWHUFKURQLFXVH /HYHOVDVJUHDWDVWLPHV5'$V PJ

(225) FDQEHXVHGVDIHO\IRU PRVW SHRSOH 7KH)RRG$GYLVRU\&RPPLWWHH )$&

(226) DGYLFHGWKDWDQLQWDNHIURPGLHWDU\ VXSSOHPHQWVVKRXOGQRWH[FHHGPJG7KHVXEMHFWRIDQXSSHUVDIHOHYHO RI YLWDPLQ%WKHUHIRUHUHTXLUHVIXUWKHUFDUHIXOVFLHQWLILFFRQVLGHUDWLRQ  PJ 'DYLWDPRQ7RWDO

(227)  PJLQWDEO 6XSSRUW7DEV/LIH3OXV

(228) PJ 9LWD0LQ YHJHWDULDQIRUPXOD

(229) 9LUWX9LWHV6XSSOHPHQWV

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

(231) 5,90UHSRUW. 7DEOHELRWLQ. ELRWLQ IRUPHUO\NQRZQ DV YLWDPLQ+ YLWDPLQ%RU FRHQ]\P5

(232) 0LQLPXP UHTXLUHPHQW 5HFRPPHQGHG GDLO\DOORZDQFH 5'$

(233) 7R[LFGRVH 6XJJHVWHGGRVH PDQXIDFWXUHU 'LHWDU\VRXUFH )XQFWLRQ. 'HILFLHQF\ V\PSWRPV. SDJHRI. ELRWLQ

(234). WKH DGHTXDWHLQWDNHLV—JG. . —J 86$

(235). . JHQHUDOO\UHJDUGHGDVEHLQJQRQWR[LF$GYHUVHHIIHFWVRIODUJHGRVDJHVRI ELRWLQKDYHQRWEHHQUHSRUWHGLQKXPDQVJLYHQWKHYLWDPLQRUDOO\7KHUHLV LQVXIILFLHQWGDWDRQZKLFKWREDVHDWROHUDEOHXSSHULQWDNHOHYHO —J 6XSHU9LWH9LWDPLQ3RZHU

(236) —J 9LWD0LQ YHJHWDULDQIRUPXOD

(237) 9LUWX9LWHV6XSSOHPHQWV

(238) —J 8OWUD3RWHQF\0XOWLSOH9LWDPLQ3RZHU&RPSDQ\

(239)  —J 1(:7216DQGULSUR6$%UX[HOOHV

(240)  HJJ\HOORZOLYHUVR\DEHDQVSHDQXWVFDUURWVFDXOLIORZHU1RWHSURGXFHG LQ FRQVLGHUDEOHTXDQWLWLHVE\LQWHVWLQDOPLFURIORUD FRHQ]\PHZKLFKZRUNVZLWKVHYHUDO%YLWDPLQV3DUWRIPDQ\HQ]\PH V\VWHPVDQGLWLVLQYROYHGLQWKHFRQYHUVLRQRIDPLQRDFLGVWRSURWHLQ ,QYROYHGLQWKHSURGXFWLRQRIHQHUJ\IURPFDUERK\GUDWHVIDWW\DFLG PHWDEROLVPDQGWKHFRQYHUVLRQRIIROLFDFLGWRDELRORJLFDOO\DFWLYHIRUP GU\ VNLQSRRUKDLUFRQGLWLRQOHJFUDPSVSRRUDSSHWLWHHF]HPDGHUPDWLWLV GHSUHVVLRQ .

(241) SDJHRI. 7DEOHIRODWH. IRODWH. 0LQLPXP UHTXLUHPHQW 5HFRPPHQGHG GDLO\DOORZDQFH 5'$

(242). 5,90UHSRUW. SWHUR\OPRQRJOXWDPLFDFLGIROLFDFLG

(243).  —J. . 0—J )—J  —J 0

(244) —J )

(245) LQWKH86$ —J 0)

(246) LQ*HUPDQ\DQG)UDQFH GHVLUHGIRODWHLQWDNH  —JGRIVXSSOHPHQWDOIROLFDFLGIRUZRPHQSODQQLQJDSUHJQDQF\WR SUHYHQW WKHRFFXUUHQFHRIQHXUDOWXEHGHIHFWV  DWRWDOLQWDNHRIDWOHDVW—JGIRUWKHJHQHUDODGXOWSRSXODWLRQWR PDLQWDLQµQRUPDO¶SODVPDKRPRF\VWHLQHOHYHOV JHQHUDOO\UHJDUGHGDVEHLQJQRQWR[LF2WKHUWKDQDIHZFDVHVRIDSSDUHQW DOOHUJLFUHDFWLRQVWKHRQO\SURSRVHGDGYHUVHHIIHFWLQKXPDQV LQWHUIHUHQFH ZLWK WKHHQWHULFDEVRUSWLRQRI=Q

(247) LVQRWVXSSRUWHGZLWKDGHTXDWHGDWD /HYHOVRIDWOHDVWWLPHV5'$V J

(248) DUHVDIH ,QWKH1HWKHUODQGVFXUUHQWO\DVDIHXSSHUOLPLWRIPJLVGHVLUDEOH EHFDXVHRIWKHPDVNLQJRIKDHPDWRORJLFDOGLVWXUEDQFHVGXHWRYLWDPLQ% GHILFLHQF\ZLWKD WRR

(249) KLJKIRODWHLQWDNH QRWHWKHELRDYDLODELOLW\RIQDWXUDOO\RFFXULQJIRODWHLVDERXWORZHU WKDQ WKDWRIIRODWHIURPVXSSOHPHQWV —J 0XOWLYLWDPLQV'$

(250)  —J 0XOWLYLWDPLQV9LWDOLD

(251)  —J 0HJD9LWDPLQ.LW&OXE9LWDPLQ

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

(253) 5,90UHSRUW. 7DEOHYLWDPLQ%. YLWDPLQ%. 0LQLPXP UHTXLUHPHQW 5HFRPPHQGHG GDLO\DOORZDQFH 5'$

(254) 7R[LFGRVH . SDJHRI. F\DQRFREDODPLQ

(255)  —J. . 0—J )—J JHQHUDOO\UHJDUGHGDVEHLQJQRQWR[LF$IHZFDVHVRIDSSDUHQWDOOHUJLF UHDFWLRQVKDYHEHHQUHSRUWHGLQKXPDQV8SSHUVDIHOLPLWVDUHKLJKO\ VSHFXODWLYH$FFRUGLQJWRWKH)RRGDQG1XWULWLRQ%RDUG 86

(256) WKHUHLV LQVXIILFLHQWHYLGHQFHWRVXEVWDQWLDWHDGYHUVHKHDOWKHIIHFWVIURPKLJKLQWDNH RI YLWDPLQ%DVREWDLQHGIURPIRRGRUVXSSOHPHQWV ,WDSSHDUVWKDW GRVDJHVRIDWOHDVWDVJUHDWDVWLPHV5'$VDUHVDIHIRUKXPDQVDQG DQLPDOV  —J 'DYLWDPRQ7RWDO

(257)  —J 8OWUD3RWHQF\0XOWLSOH9LWDPLQ3RZHU&RPSDQ\

(258)  —J 3KDUPD%/LIH6HUYLFHV

(259)   PHDWPLONFKHHVHHJJVOLYHUILVKEUHDG HVVHQWLDOIRUUHGEORRGFHOOIRUPDWLRQDQGIRUPDNLQJWKHP\HOLQVKHDWKWKDW LQVXODWHVQHUYHFHOOVDQGIRUPDNLQJ'1$:RUNVWRJHWKHUZLWK% QHHGHGIRUFDOFLXPDEVRUSWLRQ SHUQLFLRXVDQDHPLDJURZWKIDLOXUHLQFKLOGUHQWLUHGQHVVQHXULWLV GHJHQHUDWLRQRIVSLQDOFRUGGHSUHVVLRQ . 2EVHUYHGGRVH LQVXSSOHPHQWV 'LHWDU\VRXUFH )XQFWLRQ 'HILFLHQF\ V\PSWRPV. .

(260) SDJHRI. 5,90UHSRUW. 7DEOHYLWDPLQ&ZDWHUVROXEOH. YLWDPLQ&. 0LQLPXP UHTXLUHPHQW 5HFRPPHQGHG GDLO\DOORZDQFH 5'$

(261). 7R[LFGRVH. DVFRUELFDFLG

(262).  PJ. . 0PJ )PJ QRWHWKH5'$LQWKH86$LVPJ 

(263) EXWFXUUHQWO\WKH UHFRPPHQGDWLRQVIRUYLWDPLQ&LQWDNHDUHXQGHUUHYLVLRQE\WKH)RRGDQG 1XWULWLRQ%RDUGRIWKH1DWLRQDO$FDGHP\RI6FLHQFHV7KH5'$LV SURSRVHG WREHVHWDWPJGEDVHGRQH[WHQVLYHELRFKHPLFDOPROHFXODU HSLGHPLRORJLFDQGFOLQLFDOGDWD YLWDPLQ&LVUHPDUNDEO\QRQWR[LF([FHVVLYHDPRXQWVRILQJHVWHGYLWDPLQ & DUHSRRUO\DEVRUEHGDQGDOPRVWFRPSOHWHO\H[FUHWHGLQWKHXULQH 0HWDEROLFE\SURGXFWVRIDVFRUELFDFLGVXFKDVXUDWHDQGR[DODWHPD\EH LQFUHDVHGDWDKLJKLQWDNHEXWGDWDDUHFRQIOLFWLQJ 7KHRQO\DGYHUVHHIIHFWWKDWKDYHEHHQFRQVLVWHQWO\REVHUYHGLQKXPDQVDUH JDVWURLQWHVWLQDOGLVWXUEDQFHVDQGGLDUUKHDRFFXUULQJDWOHYHOVRILQWDNH QHDUO\WLPHV5'$V J

(264) ,QWDNHVRIWLPHVXS DOORZDQFH OHYHOVXSWRJGD\DSSHDUVDIHIRUKHDOWK\SHRSOH EXWFXUUHQWO\VWURQJVFLHQWLILFHYLGHQFHWRGHILQHDQGGHIHQGDVDIHXSSHU OLPLWIRUYLWDPLQ&LVQRWDYDLODEOH . . . . 9LWDPLQ&ZLOOHQKDQFHLURQDEVRUSWLRQE\PDLQWDLQLQJLURQLQLWVUHGXFHG IRUP,QFDVHVRILURQRYHUORDGRULPSDLUHGLURQPHWDEROLVPLQFUHDVHG YLWDPLQ &LQWDNHPD\EHKDUPIXOE\H[HUWLQJSURR[LGDQWHIIHFWV $WKLJKLQWDNHVLWFDQDOVRUHSODFHJOXFRVHLQDGYHUVHJO\FDWLRQUHDFWLRQV UHVXOWLQJLQFURVVOLQNVEHWZHHQSURWHLQV PJ 0XOWLYLWDPLQV.UXLGYDW

Referenties

GERELATEERDE DOCUMENTEN

Een studie welke gericht is op de veiligheid van vasoactieve medicatie, met de nadruk op extravasatie via een perifeer veneuze catheter, geeft aan dat

Als niet naar alle 71159 locaties in het studiegebied wordt gekeken, maar alleen naar de locaties waarop per tracé in 2016 de hoogste berekende concentratie stikstofdioxide

The RIVM summarizes that, on the basis of the currently established t-TDI, OEL dermal DNEL and the modelled exposures, there is a low health concern from aggregated exposure to

Indien de kosten in 2005 verdeeld worden naar sector blijkt ziekenhuiszorg en medisch specialistische zorg met 17,7 miljard euro (25,8% van de totale zorgkosten) de duurste sector

De werkgroep stelt voor om voor alle perioden waar voor vier jaar gegevens beschikbaar zijn te rapporten op basis van alle jaren, en alleen voor de laatste periode slechts

Omdat eerdere studies hebben aangetoond dat er grote verschillen in gezondheid bestaan naar sociaal-economische positie (SEP), ook wel sociaal-economische status (SES) genoemd

Coherence between the user information and risk analysis was also evaluated (Table 9). For two files, the residual risks to be dealt with in the user information were all present

Deze voorstellen voor referentiewaarden voor zeven bodemgebruiksvormen (bodemfuncties) hebben de basis gevormd voor het vaststellen van (landelijke) maximale waarden voor de