Ministerial Decree No. 17/95 laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EEC and in compliance with Commission Directive 93/67/EEC

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Tn l:yypmpo TOU r£VIKOU x,u11:lou ,:ou Kpmouc: ooie. 3000595/60/96 cJX. 3018582/2152/94. • 2. Tu~ 01~1<; TOU Opepou 1 (nap. 1, 2 KQI 3) mu N. 1338/1983 o:Eq)opµoyf) TOU KOIVOTIICOU ,:ilJCQloU• (cD.E.K. 34/-t.A'/17.3.1983) 6n~ 1pononou'19r!Kr: amho 6p8po 8 N. 1440/1984 •Iuµ1,1eroX1'1 Tile;:~ 010 K£q)QAato, OTO ano8t:µattK6 KOl one; npo~qieu; tlll; Eul){ollnol'Kf')c; TpOn~ac;: Enevlh)Oe(a)V 010 ta:qlO.\QIO Tfl, Eupc.1naYK'flc; Kou16T11tac; AYGpaK~ KOL XaAu~ Kal Tou O1)V(MOµOU E(()CX51ooµol'.J EYPATOM• {~EK 70/t.A'/21 .5.1884), 1<0 Ekik; Kai 10 Opepo 65 'tOU N. 1892/90 {<l>EK 101/t.A'/ 1990). 3. TO EM<plO O lT)i; nop. 8 'tOU up8pou 6 IOU Noµou 4328/1929 •nt:pl ouar0o£6>1; 1ou rEW<O(J Xrua:lou tou Kpa10uc;~, on~ tpononon'18nKE KOl ouµn.\l')pci)8riia: µ,; tov A.N. 754/1937 (Ap8. 3 nap. 21«113) (OIEK 247/'t.A/ 1937). 4. To Op8po 4 TOU l!.1arnyµa1oc; tTlt; 31111; OIC"lfllPplou 1929 • ncpl KOVOVlDµOU 11'1~ MtTOUpyku; KOi 'f(l)V cpyaooj>v 24 louAlou 1995 Tou Av-r.na-rou Xrn.w<ou I:ul,lflou.\lou• (<SEK 391 /1.A"/ 31.10.1929}. 5. To NOµo 11 Ci/1975 •nE::pl tpononou'1oe<.k;&oT~ TIV<AW TOU N. -4328/1929• (IPEK 172/t.A/20.8.1975). 6. T~ 0~11; 101,1 Op8p(XI 15 (nap. 2) TOU N. 1650/ 1986 -na tllY npocnaolo wu n£PlfWJ.ovr00" ~A' 160). 7. To n.A. 284/1988 1(0.1 543/1988 •OpYCJVIO'~ tou Ynoupydou Ouc<>V®ooi>V• {~EK 128 KOi 165/ A/88 KOl 229/A/69). 8. Tnv an6cpaor'i t{A)V Ynoupy<i>v n~p~ Kai OIKOVO­ i.ui<<iw y1a m:plOPlO~ t(l)V Iulloyooi>V Qpy(lv(l)V TOY Ynou~lou 01Kovoi.ui<<i.lv (11). 1078 204/927 /0CX)6Al8/8/ 1892 {<PEK 517/t.B/7.8.82). 9. Triv un' ap18µ. 01K. 91130/1988/1994 on6q,c:lcln 10u np(l)8unoUDVo0 KOi tou Ynoupyou nEX0.6E •Av68eari ap 1.1()15IOTifrc.w mrivYcpunoupyo rlei>aBt&.Uovroc. Xci>oaro£lot Kai 4111,aoakilY 'Epy6>\I EAl~ nan~• (8'884). 10. Tw;;&a1~~tC.,Vap8pc..)Y 23 (nap.1) KQI 24tou N. 1668/1986 •Ku~pvnorJ KOl Ku~tD<O 6pyavo» (A. 137) KQl 'Ua>V ap8pc,Jv0 KOi 13 10U n A/T~ 473/1996 .,l(o 8opio~ Km avaKatOV~l'I 't6W apµoc5um'Jrc,1v t<iN Ynoup­ ycl6>v• (A' 157). 11. T~ Oicrrl'q;w;; rou 6p8potJ 29A TOU N. 1558/1985 (137 A) ~ TO ap8po QU't6 npo<ntet,te ~ TO ~po 27 TOU N. 2081/19Q2 ( 154A) KO.I 10 vevovtK; on an6 t1'JV no­ pouoa an6cpaan &:v npol(QAeh'Cll &n<'MJ m: ~ TOU Kpo.1ucou npoonoAoy1crµoo, anoq,ool(ouµ£: 1 . Ey1q>?Vouµe tTIV an<,cpac:rn QPd'µ. 1 T /95 TUU A¥Wl0• tou X111,111<ou IuµJ!ouAlou ri onokl }hp8rii<E 1<016 11l oU'4 ~ioorl n,~ 24.1.95 KW ri onoia txn co.; DKOAou86ll;: rtNIKO XHMEIO KPATO~ ANQTATO XHMIKO IYMBOYAIO Ey,q>lvouµe TOV KQ8oploµ6 TWY opx(i)v ~'lant,; TWV KIV6uvfaw nou &atotxr:1 0 ~ ICOI TO nt~OY ano~ouo~ nou 'fvc,,'l(J1'on010uvtw auµIP(,,JVO 1-ittllYo&l­ ylo mu IuµjSC)uAJou 87/548/E.O.K.• O£ aulJI.IOPCPCr.l(. n~ tllY o&}yla tTJI; EnltPOffl'lc;; 93/67/E.O.K. ~ ~IK: .Apepo, ITOXOI 1. 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UTTOl+JT] K010 TfjV BICT[µnOIJ toU KIVl'.h.iVO'.: £Kr0c; ;:,c., -1cti\;;:uv-:-m 6/J.vi ,\6yrn ovnoJ;,t:ia<;. 'Ap8po 5 EKl!MHf.H •GNAYNOV, !lEPiBAAAON 1. r1a x:Clt:l.s vuoio nou yvwo1onote:l101 ollµq,wva µe: 10 up8pa 7(1 \, Sii) t; bl2) me; on6()1oon..;-AX.I: ap18µ. 3781.34 fJ appM1c ApisiJ EICTfABl l';K"Ti~tnon Ktv6Gv'ou JlO Yli; TT-EPI· Ba},.Mr,1ttKtc rri,; £'11nt(~£1<;;, r.p~no 016610 nic; orr•:i!o~ amne:M::l 'i .au:·o;roino-1: n1i; c111K1vOuv6tr1rm;. Me;1Q rnv ex:1tAca17 ni,:; mu;o-r-,oi11ori<; rnc; tntKtv6uv<rrnrm;: n ,,1pµ6 5m A.pxll ,cKTc/'.c1 ·nt; c~r·t; cvtpye,ei; ollµq:;ulvo µc 11,; KO­ n:u9u11J;1ne,; ',:.oµµt,: ; 1""'.ou K0Eopl~ovta1 :no nap6prnµa f]) i\ £1(tlunorJ Ei6onr; ,:QuyKtvi:p(i)anc;) - 'lrt6Kp1onc (er1i~ mwonc:L E:W6aov elvm anapoim10, ii) etCT"iµ 10n tKBeonc; v,a TO 1ul')µ01c TOIJ n~p1fl6,\Aovroc; 1r..x. uOO;:vo, xi::poaio rrep1!3Cl,\.~o,1 K'01 mµ6o(J)01pc.) nou ,~votxerm va 2;cre8ot;v mn ouyKeKp1µtvr1 ouolo. /3) xopmnn( \!0µ6 1<1vi5uvou. 2 .. ¼'.or(' r;np.:'KX:A1ori ~7~ nooayp.jq>ou 1 • ') 6oov O',',op<'.l ouoic: nou yvc,:ooronoioUvrm t:16.oel ,:ow 6p8pou 7· 1: n1c: an6qioonc; AXI op1811. 378/94 a>J.6. fie;; ra~.vcµo(,vi:CJ, ('1{, r;m;dvl5uvec; y10 re, nep1~o>J.ov, n e1CTl­ ~1r:•1'1 K!Vl'.t1>'ov Ciev ova: anopolTITro va m;plf.aµf!Clve! rn; E:V~''{f:te,;: l7GU '16;'.)lypCIQ)OV'tCl CITllV no[)Oy oocpo 1 (a) KOi i:'3!, KOi CtTjV TTE/,lf'TWOfl ou1T11ax.Ue: TC ouµntpaoµa toll s'1p6i::ou 3 (4) ;:; t.KT6c,; eOv u~lomvra1 ON\ot ooflopoi >.ovm (1VT]OL}:ior· KOi 'i\ via 1:;;: 0UC1tL, l10U VV6>0TOTTOlOlJvrm ollµ(l)(.,)va µ.E TC apapo s1· .111 B :?, •ni:; an6<poonc; A.X.r. ap181-1. 378/9411 yto r:c; on :>\t~ r:·, ·.),., -, unofl~n6ei np6o8ern<; nA11po1v0p!E:c; i5uvctµe, 10,J ,.,;.:,t,!1·)l; e nap. 3 111c; cv >.oyw an6qloor,i; A.X.L e0-1 bev ,1,1c)i::,..0vv enapKJl 15e~oµtva npo11:e11,itvou va K08op;on:I KCTC. n6o,::v elvm anopalmTo 01 ouoiec; au 1tr; va m/;1vour,8ollv ~,, :·r11xiv0Uvo; y10 10 m::ptfloMov, T1 1ou1onolr1ori Tll~ emK(s"6uv0117ro<; ouvcn6yetot etttoori 1ou KmCI 16oov cuvrptxo,1v ,\6•101 ovnouxloc; 6oov mpop6 11r; n::::p1~0JJ.ov11tcli; enm«i.>oc.,(; !360£1 6Mulv OCOOµtvwv, :l.x. 15e0o,Jtvwv nou mpopollv rn; rpuacK.:rxnµ1Ktc; Kot 1~1 Ktt; 1151Cm11ec;. Eq>baov 15i::v uqilcnavto1 oofmpol Mvo1, n CKTijlflOTJ n,:iv Kivl5UvulV Ocv elvm onop□llllTO vo ncptJ,,0µ60ve1 T1c; cvtp­ veie<; 1:11<; nopoypOcpoLI 1 (a) Kai jfl), x:m mnv neplmooan aull'I 1axllei 10 ouµntpooµa 1ou Clp8pou 3(4) (i). "ApBpo 6 EKTIMHI:H KINAYNOY: D'MnEPAIMATA 1. H op;161510 Apxll, acpoo eKTeA&Oc1 mv E:KTlµriOTJ Ktv15ll vou oOµ(l)(.,)VQ µe TO Op8po 4 KOi ,:o 6p8po 5 KOi 10 nopop­ trlµma 1, 2 KOi 3 Ka8oplt;e1, oUµqKilVO µe TO noo6.Pm1-10 4, not6 ll no1Cl an6 TO rtooepa ouµnepOaµam TOU Op8pou 3 ( 4) l0)(0Cl ( IO)(IJOUV) KOi avaAaµfSOvet 15pOon oOµ(l)(.,)Va µc TO nep1ex6µevo TOU ap8pou 3 (5) ecpooov elvo1 onopal­ n,10. 2. H eKTQJnon Ktv150vou n onolo eKTcAeiTat oOµq,wvo µe ra Qp8pa 4 Ko1 5 Kot,:□ napopT11µ010 1 . 2 Kot 3 cnave(eT0 7,crm KOi ev&:xoµtvc.:x; ovo8cwpeltm, fSOoe1 TulV ouµnAn­ PWIJO~!KWv nAnpoq>ep16:iv nou unofl0Movra1 15uvOµe1 1wv 6.pBpwv 7(2), 8(3), 8(4), 14(1) f\ 16 me; anOq>aon<; AXI op1::.:. 378/9411 O,\i\wv mwwv. .Ap8po 7 rlEP!EXOMENO THr \PAnTHr EK0EIHr nPor THN ErllTPOnH ~. H upµ615in ¾ix!'\, ocpo(J e1CTe>.toe1 TIW eKTlµnon K1vl5ll­ '•ou ollµqiwvo µe ,:a Op8po 4 KOi 5 K□1 1510TUnOOe1 auµne­ ;:iOoµota oUµq,c,:iva 1-1e 10 op8po 6, eKTTovei vpanTI'l tK8ean nE:pit)(ou,;::,a 1ouMx1otov 11c; n,\TJpo(pOplec; nou K□8op~o­ 'rrat 010 TTOPClPTil!-10 5. H tK8CCJ11 au1fl onoottMemt amv Ernrporni ollµ$1,lvo µe ro 6p8po 17 1nc; on6cpaonc; AXI: 'lf)IF.l. 378/94 KOl KOtvono1elTOL OTtllr' apµ~lQ Ynnpeola 11cptjjoMovtoc; lOU Yn. nE.XQ.A.E. To KC[µev6 Tll<;" cvn­ Sl£j'. ,::i:,vera1 µe16 un6 01afiOr.o1e avoOewPnon me; eKTlµn­ :m<; !36oe1 m11m.hjpwµ□nKWv nA11pocpop1WV Ko1 ri cvnµe­ ,-,wi,:::-,,,., tKfleon onoa1t>J.e101 omv Em1pom;. :? ·orav, a(iµcpwva µe 10 6p9po 18 TllC: onO<POanc; AXr. c;p1E.; 378194 01 opµ6151ci; Apxtc; KOTcV.T')(ouv oe ouµcpwvla •!)(icu uq,opo rn ypanTii t:i,;Bcan y10 nw eKTiµ11an Ktv15Uvou T1 (Jl'::;?;l'lr,on: avc.8eWf1l70r\ Tll<;, OVTlypo(J)O 1510118€:TOI OtOV w~v1or-010Llvro µeT6 1ri 151otllnwori CJ)(enKoll 0111)µ0• ioc; "Ap8po 8 H naoollaa C1uvoOeUerm onO ntvu: (5) nopapTT1µ010 nou cmo1e.\0Uv ovan6onoo10 Tµllµo ouTI'lc;. nAPAPTHMA 1 tKTIMHrn K!N6YNOY: AN6PQrllNH YrEtA {TO=tKO­ "!"HTA) MEPOr A Ka10 Tl]V c;!l,l\jJ•\OTJ KIV~UV(,)V nou eKTehciTOL aUµq)v.lVO [IE TO 6.p8po 4 Aoµfl6vOVTOI un61+.1n rn ~T')<; i5UV11llKt<; TO~l­ Ktc; emnr<00e1<; oe ouv6uaoµ6 µe rouc; nA118uaµoUc; nou evl5t)(CTOI VO eKTe8ollv: ErnnTQIEII AN0PQnJNOI nAH6YIMOI 1 l O~lo ro(tK6Tn,TO 1} Epval;Oµevo1 2) Epe810µ6r; 3:, btoj?.pwttKOTiltO 4'.- Eu□10Bn10noirJon 5) Tc~1K6Tni:a enav/µevnc; '36anc; 2) Komvoi\wtti; 6) Me1aM~1vtveon 7) KopK1voytveori 8} Tcl;1K6TI71a y1a 1nv avonopaywvl'l3) Ko1v6 CKTt8tµevo tµµeao µtow TOU nep~OVToc; MEPOr ff 1. TAYTOnOIHIH EnlKINAYNOTHTAI 1 .1. rnc; ncp1mCOOe1c; Ko TO nc; onoiec; n OOK1µf\ nou elvm KotO.UnAn via mv -roui:onoinOTJ TllC: emK1vl5uvotT110<; ae CJXtOTJ npoc; ouyKeKp1µtvn 15uvntucl') enlmcoon txe, cKTe­ i\eon;l o,\,\6 ro anoT&MoµaTO lS&v olST'JVTJOOV OE: TO~IV6 µTJOT) (6.p0po 4 (2) @, o Xapotm1PIOIJ6c; TOU t<IVl5UVou oe axton npoc; rnv ouyKeKp11-1tvn enlmcoon l'.iev elvm anapoi­ TnToc; eKT6c; 00.v ouvrptxouv O.Uot ao~apol A6yo1 avnou 7596 E41HMEPII: THI: KYBEPNHl:Elll: (TEYXOI: 4EYTEPO) x~ Onwc; VlO napMeiyµa 8etucO anoteMoµaro in vttro yIa TflV µMaM~iyMOTl. 1.2. I~neP1m<i)oeic; KatO ~ onolec;n tsotaµfl nou elvcu anopalt11T11 VlO TTJV TOIJtOffOll)Ol'I lT)I; enuav&Jv6Tnt~ oe oxton npo4; olJ'{KeKPiµtvn 15uvrrma't cnim<,,)OJ'J ~ t:xeI OK6µn £K'teAeof&l (Op8po 4(2)(iij), 0 XopaKTllPlO~ TOU Ktvl5UY0u oe oxtan n~ TflV OIJVKE:~ cntrmoari l5ev elvoI onopotnrrcw; eKtO/; 00V ouvtptxouv 6Mot ~I AOyot avnaux~ Onc.:ic; VIO napO&:iyµa nP0PAl11JQTI01JOI oxettKO-µe 1l1Y tK8eon l'l cv&~lf; eva£x6µevnc; 1~11<6'rn 1oc; A6yw aATJAent6paoe(i)\I OUVTOKtll((.i)v Tfm(l)V KOt ~an­ K6TI)tac;. 2. EKTIMHIH ll.OIHI (IYfKENTPQIHI) - ArlOKPl­ tHt (EnlnTQtHl:) 2.1. ·ooov aq,opa TffV 1~11COn,ta cnavaA.aµPav6µevril; Mane; KOi ll'lV ~K6tnta oxe-ru<6 µ& nw avanapaywvr'l cnt~TQI va CK't&AEOTSI &K'tl!Jnon TTK oxtanc: ~c; an6KpIonc;: Kai e<p6oov eiva115uvaTOV, va 1ou1ono1n8el to cnlneOO µtxp1 to onoio 15ev nap(m')po\Jvtai avcn180µn1ei; evtpyel6l; {NOAELJ. Eav civot Gauvotll n routonolnon 'tOU NOAEL TOUtonoieha1 11 xaµnAarePTl l56orJ I ouylCtvrp(OOf] nou ouvUeto1 µe µla 15uoµcvr'i enlmc.>oll &\Aal51'l to xa1,1n­ ,\6n:po enlnc&> napaT!'lPnonc; !5uoµ&WW emm<i>oe6>v (LOAEL). 2.2. I~ neptrmixrel(; TilC: ~£ICM; T~KOfT]tac;-, lT)I; 151C1 l3j)(l)lt1C6tntac;: Kat rou epe81oµoo ouvi}8~ elvcu aauvo.10 VO npool'.i1opmel TO NOAEL I') n LOAEL poae1 Tc.>V anoTE;­ AeoµO.tc.>V toov 150KQJ.cilV nou txouv et("[E:,\eotei oUµ(pCA)Va µe nc; ona1Tl'!oe11; Tlll; anOcpaonc; AXI. ap18µ. 378/94. raa TllV neplmc,:,on Tlll; o(elac; t~ll(OTTltac; npool'.i10pl(avtat ot n­ µt<; W50 I') LC50 I') eq>OOOV txe1 XPl10IJ10TI011l8ei ll &ol'.i1 Kaola K08op1oµtvr)c; Mone;, n Kplo1µn Moll yI0 TllV np6 KA.non 15uoµevcilv emmci>oec.:iv. rta w; un6Aoine<; emmci>­ oeIc; apKei vo npoo01op~to1 KotO. nooov n ouola l'.i108tte1 eyyevl') 1Kov6Trtro nP6KA.nonc; ovaMywv emmc.xJec.>V. 2.3. ·ooov aq,opa Til µet~1Ytveon KOt TI1V KOPKIVO­ vtveon optcel va npooi51op1crrel Kato. n6oov n ouola &o8t­ ua c.>c eK Tlll; cpUoe<,>c; Tlll; tKav6Tlltoc; nP6KA.nonc; avoA6 ywv emmcixrec.>V. Ev t0UtoIc; e(J)OOov onoi5eix8el 6n µ10 ouola 11 onola TOUTOTIOteiTOI we; KOPKIVOVOV<>c; l'.iev elvaI yovilStOT~LKI') Kplvetat OK6ffll,.IO va TOUTOn01118&i avti­ OTOIXO NOAEL/LOAEL 6nc.>c nep1yp6q)eTOI crrnv nap6. ypaq>o 2.1 . ~ 2.4. ·oaov acpopO Til 6£pµot1KI') euatoBntonolnon KOL TTJV avanveuotua') euoto8ntonolnon, e<p6oov i5ev emwv­ xovetaI ouva\vean oXE:TIKO µe TllV lSuvat6TI1TO TOUTOnoln­ anc; µlac; Monc;/auylCtvrP<OOll<: K6.tw an6 TilV onola e\vaI onl8ovo va eµcpaviotoUv lSuaµeve~ emnt<i>oeIc; ere O.toµo l')lSn eu01oentono1nµtvo ae lSi&&>µtvn ouola, optcel vo a~10AoV118&i KOtO. n6oov n ouola lSiUvatat c.>c eK Tll<: q,U­ oeci><; Ttl<: vo npoKaA.el avMoyec; emmc.xJe1c;. 3. EKTIMHIH EK8EIHI 3.1 . EKTlµnon tK8eonc; E:KteA&ITOI VKl tKOOTO tc.>v ov 8pwnlvc.:iv nAn8uoµcilV (&pyo(6µ&vot, KOtOvaA6>ttc; KOi KOIV6 nou evatx,eta1 va etcte8el tµµeoa µtow tou nep1 136Mavtoc;) 01onolo113001µ0 ovaµtverot va eKTe8oUV OTI1V OUVKEKp1µtvn ouola. I:t6xo me: &tctlµnanc; anot&Ael n l'.imtUnc.oon nooottKoO I') no1ot1KoO unoJ+.oy10µ0U Tll<: Monc;/auyKtvtpc,:,onc; Tll<: ouolac; OTTlV onola tvac; nAn8uoµ6c; &KT!Betat I') evatx,eta1 vo eKte8&I. Itouc; ev J+.6yoo unoJ+.oy10µ0Uc; J+.aµpo.vovrat un641n 01 TOnLKt«; KOi XPOVIKtc; anoll'.A.loeu; Tc.>V XQPOKTl')­ pc.:iv 'Hlt; tKBE.:oT]c;. 3.2. H E.:KTlµnon Tlll; tK8eonc; Ba j3oa~&Tat crrIc; nAnpo­ (()Opi&c; nou nep1tx&1 o t&XlflK61;: q)Ql(&Uoc; nou uno~O..U.e­ tm oUµq,c.>va µ& TO tµl')µo 2 TOU napapUJµmoc; vu A, VII B, 1') VH r TIK an~ /JX. ap&8µ. 378/94 l'I OtOat,nare 6.UJ\ &oetolµl'J axC'TIK'l'i nAnpocpopio. AvoAoya µe T1lV ne. plrm.>arJ ~• l&attp(,)(; un6t&Jn: ~ l<Otb.\An).a IJETPl18tvtO ~111:va tldl""'l~, iO n noaOtr)ta Tll<: ouoiac; OTTlV ayopO. Ill) n µopq,n unO 1'f1V onola 15ultavetrat eµnoptK6 KQl/1') J(pll0ijlno1£trat n ouoia {napal5£lyµaroc; xOpn ere K08apf) IJ()l)q>n n ~ OUOTOTil«I TI-IKITO<:)' Iv) 01 KGTilVoPiec; XPl'loll<: KOi O Pa~ ouytq'.Kffll(JJ1c;, v) &&>µtva axenKO. µe TN; µe86oouc; ene(epyao~ eq,' 6oov unOpxouv, vl) 01 (pUOIKOXfllJIKtc; 115tOTr)T&c; Tll<: ouoiac; ouµnepL¼,1 lkwoµtvoov, eq,Ooov uflCll)Xouv, eKeiv<ov nou anolC'TO Aoyoo TIK en&Eepyoo~ tTK (napa&tyµaroc; xOpn OJClllJOTlc,µ6(; aepoN.lµO,'l'Ci>V), vi) 01 meavtc; nopelec; tKBeonc; KOi 11 8uvot6tnto anoP­ p6cprJon~. viij T1 aUXV6'nlta KOi n 6t61'.)KEIQ me; tKBoonc;, ix) tU'l"lo,; K0I µtye8o,; rou ouytceKPLl,.ltvou e1metµevou n>.neuoµoU (ci)v), 6tav ttt01ou eloouc; nAr]poq,oplec; elvaI &o8to1µec;. 3.3. Eq,Ooov XP'IOllJOTI01fl8olJV µt8o(5o1 nPDPAE\11111; via tov uno>.oytoµO tc.>V emnt&.w tKBeonc; npot11,1olivrat, &q,6oov unOpxouv, ta CJX&tu<O. 15£00µtva napQK0Ao(l8r)­ anc;· an6 ouolec; µe avMovn XPnon KOi tp6no tK8ec,nc;. 3.4. E6v 1-11a ouola nepltX,ETCU oe napamreUOOµa, 11 e(t­ taon ev&:x~c; tKeeanc; O'Tl1 ouyK&KpiµtvJt ouoia &VT6c; 1'0U napaaKeUO.Oµatoc; Kplv&tat onapoltrrnl µ6vo oov to teA&utalo ~µelro1 poae1 tCi>V t~1KoAoyu(cilV ~ ~ ooolao;-.., ""'an6qxlon =-378/94, ""'owtptJ(ouv IJ»o.-lh,a <M]OUJ(D;. 4. XAPAKTHPltMOt KINt.YNOY 4.1. Ecp6dbv y1a on0ta61')n01'E an6 tic; emmc.xJeu; nou avocptpovrm crro napOptnµa 1 A routono111Bel tva NO­ AEL I') 1,1la LOAEL, 0 XOP0KTl1PI0!-16c; KIVliUvou oe axton npoc; tro8e µla on6 auttc; tu; emmcooe:11; oUV£nOyeroI OU­ VKPIOfl tOU NOAEL I') Tlll; LOAEL, µe TllV uno>.o~6µevn Mon/ouyictvrpc,>arJ tK8eanc; tou n>.n8uo1,10U I') twv nAn 8uoµcilV. EOV un6pxe1 noo01'lK6c; unoAoy1oµ6c; yIa Till/ tK­ Beon uno,\oy~o1 o avtkrn>ixoc; A6yoc; emnt6ou tKe&onc; /N(L)OAEL. H ap1,16lS10 ApXl'l anoq>aa~l, POoe1 me; oll­ VKPl<JTK µet~U TOU ffOOOTIKOIJ I') TOU notOTIKOU unoJ+.oyt­ oµoo tKEloonc; KOi tou N(L)OAEL, no16 an6 ta "ttooepa ou­ µnep6oµaro tou O,p8pou 3( 4) 1oX,Ue1. 4.2. E(J)OOov liev Ko8oplot&i N(L)OAEL, VKl ono1015il')­ not& an6 "ltc; enmc.xJe1c; nou avacptpovra1 crro napOptnµa 1 A o XCIPOTT\P10µ6c; 1<1vlSiUvou oe axton µe K08e µlo an6 outtc; nc: emmCOOeu; ouvenO.yetot ~o>.6ynon, po.o-e1 no­ OOTIK<ilv KOt/1') TIOIOTIK6w nJ+.11pocpop1ci>V VIO lT)V tK8oorJ 'l'CilV ~et~oµtl/Ci>V av8P(i)nlvc.>v n>.n8uoµcilV, Tl'IC: mBav6TI1tac; va Ao.Pet 6VTc.>c xci>pa n ouvtceKP1µtvn enlmcoon1. MetO. mv ~10J+.6ynon n apµ6151a APXl'I anocpaol{et not6 an6 ta tto­ oepa ouµnep6oµata tou OpBpou 3(4) KJXl'.le1. 4.3. ·otav n apµ6&a APXl'I anoq:,oo~t noi6 an6 to tto­ o&po ouµnepOoµoro wu O.p8pou 3(4) 1axOeI Aaµ~OVet un6ll}Tl µet~U a],,.},.(l)V: (1) 'Otav IJOM)VOTI 6ev txe1 Ka8<>91on:I N(L)OAEL. TO onoteAt­ oµata T<,IV CloK1µcilv anol'.iE.:LKViJouv 6'n unop):e1 axt:011 µe-ra«J 00 011c;touyt(Mpr,)OJK KOi ootkiPOTITto.; µicu; &.!oJlev()LII; enlmc.>artc; f1 eq>6oov, oe axtori µE: µKl µt:80&) &>KIIJl'lc; nou ouvenllyt:Tat trJ XPTIOfl anoKAe10TIKQ Kot µ6vo µtac; &x1r!c; l'l ouyKtv'tp(t)Oflc;, t:lvaI liuvau'I n ~KIAOynorJ TI1c; axeuKl'lc; ooll0PO'fllT~ 1,11a!; enlm(o)(7l'Jc;. 01 a~ nA11pocpoplec; ~ en\anc; un6111T1 KOtO TI1V a(lo"6Vrlon TTK' m8av6mt~ e1,1(1)6.vlOT)c; avMovllt; en\mu>OT}(; OTJlV npayµaruroTflta. • • EGIHMEPll THl KYBEPNHlESll (TEYXOl llEYTEPO) 7597 , Q tnv aPE:jklt6TT]ro nou IJE:t~U bM.c.w napay6vtc.w oq,el­ Ac,w O'tl'IV &coo'.lµOVOI') TC.W TTC1PQµa.TIK6)V ,lSe&µt\K,.w KOi otu; &a~ ~u TOU !Olou el~~ KOi ~I,) i5Klql0 P6TLKWV' &l&ilv. E/\00.1 IQ Tl1 cpllCJTl KOt Tl1 ~a t<i:IY cmm&r oec.w. HQ tov ov8pcim1vo nAn8uoµ6 \'Ill tov onoio IO}(Oouv 0t no­ oou~ Kall!'! TTOlOTI~ 151a8toqrer;; nAnpoq,opl£r;; . 5. 01\0KAHPQIH (rYNOfJKH EKTIMHIH) 5.1. IIJIJ.q:KMJ µe tu; &atbtetc; TOU 6p8pou 4(1 ), ewtxe­ TOI VO tKteAtolel XOPGKTTlptCIIJ~ KIVi5llVOu oe axton µe nep1oo6tepec;: an6 µia evOex6µev~ 15uo~~ emmW­ aeu; I') av8pcim1vouc; nM]8uo1,.101'.M;;. It1r;; neptm<i.loeu; autb;: n apµo&a Apxn Kplve1 0010 an6 to ttocrepa ou1..1nep6 01,1ata TOU apepou 3(4) 1axUe1 VIO tl«lOTTl enlmcoon. M&TO. tT)V oAoKAl'lpcoon TllC: eKTlµnOTJ'i: TOU KIWUVOu, !l opµM1a APXI'\ t(eta{et ta 15t6q)opa ouµnepOaµato npoKetµtvou va 15tatunci>oc1 ev1ola ouµn£p6ol,lata oe axton µe 111 ouvo­ A1tdl t~IK6tnto TtlC: ouo~. nAPAPTHMA 2 EKTIMHIH KINAYNOY: AN8POrnNH YrEIA (<l>YDKO­ XHMIKEI IAOTHTEI) MEPOIA. Kat6. TflV £KTiµl')OTl K1Vlluvou 0'411J,16)va µe TO bp8po 4 Aaµ~vovrm un611,1n 01 15uvnt1Kb; &io~e~ emmcixJetc; nou evM)(etot vo nop0T11Pn8oUV OTouc; OK6Aou8ouc; av 8pci>mvouc; n, 8uaµollc; Abyoo tK8eoi'lc; touc; ae ouolec; µe tu; ~l'lc; 1l516nrrcc;: I.6.IOTHTE:[ 1. EKPl1Klll<6T11TO 2. Avacp~1µ6TT]TO 3. 0~1&.mK6 l5uvoµ1K6 AN8PCnlNOI nAH8YI:MOI 1. Epv<@µevo1 2. Katava,\c.:Jt~ 3. Ko1v6 CK'Tt8tµcvo tµµcaa µtaoo nep1~oi; MEPOI B 1. TAYTOnOIHrH EnlKIN.6YNOTHTAI: 1.1. rt1c; nep1nt<OOetc; nou µet6 TTW eKtt.\eon tc.w Kota,\­ AnAoov l5otaµa>v y10 T11V tout0no1nan emtavl5uv6Ttltac; ae axton npcx; ouyKeKpiµtvn 1l516'rnm TO onotc>.taµom &:v ol5nvouv ae t~v6µnan [Op8po 4(2)(i)J, o X0POKT11Ptoµ6c; KlVlSuVOU QC oXeoJl npoc; T11 OUVK&KplµtvT} 1lSt6T11tO OCV Kplvetat onapalTT1toi; eKT6c; cOV ouv.ptxouv OM01 aopa­ pol A6yo1 ovnauxlac;. 1.2. It1c; nepmtcixJ&1c; KOU! tic; ono\ec; l5ev txe1 aK6µn eKTe.\eOTel n KOtOMnAn l5otaµfl via TT1V toutonoinan cm­ K1vlSuv6TT1tac; oe axtan npoc; µ10 OUyKeKptµtvn tl516TT]tO [Op8po 4(2)(Q] l5ev elvm anopalTT1TT1 n eKttAean xapaKTT1 p1aµoU Ktvl5UVou, Vta TllV OUVKE!q)lµtvn 1&6Tnta eKtbl;; eOv ouv,:ptxouv OM01 oof,opol A6yo1 ovnauxlac;. 2. EKTIMHIH EK8ErHr 2.1. EOv O xapm<TT1PI0µ6c; KtVlSOVOU nptnet VO eKt&,\c­ otel oUµq>u>va µe to Op8po 4(2), apKel va K08opLOToUv anM:lc; KOi µOVo 01 avaµev6µevec; ouv8flKcc; XPl'lonc; ~Ooet toov n, poq>oplCilv tou texvuroll cpo.Kt,\ou VlO TTlV ouola Onooc; Ka8op~e1 TO tµl'lµa 2 TOU nopapTTiµatoc; VII A, VII B, fl VII r Tllt; an6cpaonc; A.X.I. ap18µ. 378/94. 2. XAPAKTHPIIMOI KIN.6.YNOY 3.1. 0 XOj)QKTIJp10µ6c; tavl5Uvou ouvenOy&TQI ~10A6 vnon T11c; m8av6TT1tac; np6KAnonc; &Joµevtiw emntcixJ&oov uno tit; omo,\oynµtva avaµevOµevec; ouv91'ltcec; XPflanc;. Ecp6oov auTI') n ~toAovnon uno0e1KVUc1 TilV anouo\a ~u­ oµevcbv emmtooeoov, ouvi)8ooc; 1ax.Uc1 to ouµntpaoµa tou Op8pou 3(4)(i). Ecp6oov auTT') n ~10A6vnon uno0&1KVUe1 6n ea unOp~e• l5uQJ.1£Vl'ic; entmcoon, o~ tax{lel to ouµntpaoµa tou l,p8oo 3(4J(lv), 4. OAOKAHPQI:H (rYNOAIKH EKTIMHJ:H) 4.1 • ·onou txouv &arunr.,8ci &aq,opttll<b; ouarOa&tc; VIO µeKl>Oll TOU KIV6uvou C,X&Tuc6 µe iStaoptru<tc; cmm(i).. 0£«; n ov8o<i>n1V0U~ nArJ81Joµoll<;, -QI ... ,0 T11V oAoKAf\pcoori 'tilt; &KTlµflOllt; TOU KtYl5UVOIJ KOt 11 apµ6 l5ta Aoxll l5taµopcpcmi oAoKArux•.,tv«; a~. rlAPAPTHMA 3 EKTIMHDi KIN.6YNOY: nEPIBAMON 1. TAYTOnOIHJ:H EnlKl~YNOTHTAI. 1.1. rta nc; ouoiE:c; nou aev ~ivoµouvt01 ooc; enudv&t­ ~ ym ro nep,tl(IA,\ov (-5(2)@, n ap.,-Aoxll $­ tt#:1av ouvtptx,ouv6Motoc$lpol,\Oyo1untpT11c &KltAe­ oni;: XOpat<lTlptc,µo(J ICIVl5UVOu Aaµ~ovtetc; l&mttpc,,)c; UTT6ll,ll'l: i) nc; ev&:~ VIO T11 lS1.MJt6nyra PtoOUooo,peuoJlc;. Ii) TO oXl'lµa lflt; KaµnO,\r\i;: To(IK6Tr)roc;/,cp6vou one ik>­ Klµtc; OIKOT~K6'nltoc;. ii) evl5£1E&u;: VlO OMc(; l5uoµeveli;: cntm~ paoe1 tc.w µcActci>V •~IK6TrJtac; 6nooc; yta napMctyµa ~l'lon ooc; µ&taM~, T~KO, noMI t$6il en~ ouvo&:u­ l>µevo ano ll1 cppaol'l Ktvlit'.Jvou R40 ( •ev6ex6µcvoc; t<ivl5u­ voi; µr, avnotpem(i>v cntmci>oec.iv•) ii R48 (•Kivl5uvoc; 00 ·papflc; PMPl'lc; U1c; uvclac; ae neptmoon napatctOIJ&VT'lc; tK8eonc;•). iv) &:ooµtva yLa ouoiec; avaAoVT1c; l5oµl')c;. 1.2. E(IK)OOV n apµlx510 Apxn 8ec,:,pel On owrptx,ouv ao­ f,opol A6yol YID T1W cKtt>.eon xapaKTT1p1oµoO KIVOOVOU 000V acpop6 µla ouala n onola aev txc1 ~µn8el ooc; E:11\Klv6uvn via TO nepiPbMov KQl VIO ll'IV onola l5ev l5to.Tl 8evta1 enapKT\ &:&>µtva oxetlKO µe tu; cmmciloetc; T11c; OTOUt; opyOVICJµoOc; (6p8po 5 (2) ~i), avaAaµjkwE1, &q>6oov KPIV&TOI anapattnto, ap(lon oOµqx,>VO µe TO ap8po 3(4){1i) n "''· 2. EKTIMHI:H .6.0I:HI (rYrKENTPQI:HI.) - AnOKPIJ:HI. (EnlnTQIHI) 2.1. I.t6xo anote>.ei n nP0P.>.ellJn T11c;ouyKtvtpcooric; ~ oualai;: KOToo an6 T1W onola &:v avaµtvct01 va napalf1pn 8oUV l5uoµevck; emmei>oe1c; oto $t~µevo tµf)µa -rou neplfW.,\OV"tl)I;. H ooc; {Jv{I) ouyKtvtpcoori clva1 yv6lOTI'! ooi;: npopAcn6µevn ouyKtvtpc.oon Oveu enm(l)(JC6)V (PNEC). 2.2. H PNEC Ka8op~a1 paoe1 toov n, poq,opt<i,,v nou nep1txOVT01 OTO q>liK&Ao yv6>0Tonolnonc; oxet1KO µe nc; &ntmci>oe1c; OlOUC: opyavwµo(Jc; 6nc,x; K08op~t lO tµfiµa 5 tou napapTTiµotoc; VII A ii VII B U1c; an6q)aoni;: A.X.I.. OPl8. 378/94 KOi 01 µe,\tl&<; otKOt()QK0TI'JTac; nou avacpt­ pov.01 OTO nap{JpTT}µO VIII (cnlneOO 1 KOi 2) Tllt; npoava­ q>Ep8cloac; anOcpaonc;. 2.3. H PNEC uno,\oyi&TOLOUVQPT1iCJe1 ouvte,\ecm') eKTl­ µnonc pooe1 toov tQJa>v nou nj)OK\Jmouv ano tic; llotaµtc; oe opyav10µ0Ui;:, 6nc.x; yta nap0&:1yµa LD50 (µton eava­ Tll~ Mon), LC50 (µton 8aVOT11rp6poc; ouyKtvlP6)Clll), EC50 (µton anotcAcoµottKT'I ouyKtvrpcoon), IC50 (ouyKt­ vtPoon npoKaAoOoa KOT6. 50% QVOOTOAfl O JVKCKPtµtvnc; napaµttpou 6nooc; yto nap0&:1yµa llll; avOmutnc;), NO­ EL(C) (enlnel5o/ou\fK&vtp(,)OTl Oveu napat11pouµtvc.>v en1 mcixJ&oov), f) LOEL(C) (Xaµ11A6ttpo(n)/enlnel5o/ouyKt­ vtpooon napaTTlpr,onc; ennnWOec.w). 2.4. 0 0UVT&AeO't'l)I; E:K'tq.illCJTIC anots>.cl b<:q>paCJTl tou pa8µo0 apef,oLOtntac; OTTJ µetacpopO ne1PO,µat1KWV 15efu­ µtvoov neptaptoµtvou apt.8µ00 e1&iw oto npayµatlKO ne­ p$0A}.ov. Qc; &K toutou ev ytvet 6oo ava,\ut1K6ttpa e\vat 7598 ECl>HMEPII THI KYBEPNHIE!lI (TEYXOI AEYTEPO) rn 15eOOµtva Kai µeycV..Un::pn n 1510pKem twv 150K1µW-v 1000 µetWVeTOl o f306µ6,; aj3e:f3ot6Tr)'rai; KOi 11 11µ1') TOU !!Op6.yo­ VTO ewrlµnonc;. 1 3. EKTIMHI:H EK8EIHr 3.1. rr6xo nv; ewrlµnon,; tK8eonc; rinoreAr-1 11 n;::i6 13Aei..in rn<; ouyKtvrp,.ion<; un6 n1v onola ev15exoµtvw<; n ouola 8a ouvaVTnSe: OTO nep1~ov, H ev My0 uuyKt­ vrpulon e!vm yvw01f wi; npol3.\en6µevr] m:p1!3aM.ovT1Kl7 ouyKtVTpwon (PEG). 001600 oe op1oµt•:c,; ~eo1n1.j){Jf.1<,;, cvMxe:T'::a va e!vo, o~jvotot; o Ka8op10µ6:, TT]<; PEC 1-:·.:c. V':i Ka8lOTOTOl unoxpe<,11 IK6c; o TTOl0Tl'<6c: uno.'ov10µ~ bs}k OT](;. 3.2. H PEC ti, eq,Coov q'.lt8el onop 1,rrr·o, 0 :·1\.:1:m~,.'.,;; un0Aoy10µ6c; TTJ<; EK"Beonc; npoo151opi~nrn p6,10 yw: 1"'. rµt]µarn rou m:p1fl,M ~ovwc; era onolo e<:Aoyo np'..)!3).i!:n,::­ m1 va unap;ouv axet1Kt<; eKnoµnCt-;, 011oppi1.ue1t,, am,f!t­ orn; 17 61cvoµtc;. 3.3. H PEC 1'i o !lOK•nK6{; un0Aoy10µ6,;; 8K9t'..O\l~ Ka0op1 ~0VTOI ,860£1 TWV n,\J1l)O(l)Op1W--, nou llC()L\aµi36vovm1 ,JTO\' 1exv11<6 q,6KeMo Onwc; opl~erm am rmpaptl'iµmo VIIA, VII B, VII r l'J OTO nap6i:i-·ru.K1 VIII TT]<; an&paonc; A.X l° ap1R 378/94 ouµm::plAaµj:!avoµt.:vwv: i) KaTa,lJ,l'JAwc; µe-rpl']0tvtwv 6e6nµtvwv t:KElecrnc ii) TT]<; noo6tnm; 1nc; oucrlm; 01nv ayopl'.l. iii) tnc; µop(l)l'\<; unt• nw ono!o n ouohJ ~,1mlBetui m:r1v ayop6 Kai It'\ xpnm~tonmeitai (n.x. un6 Ka9op!' µopq;1'117 w:; f!!JOTOTIK6 napooK£U•)CTUOTOC:) iv) TUIV l<Ot11YOPHcW XP'1'-''l~ KOi TCLl 8111:!polJ cuy1<p6m­ onc;. v) ·uJ)V 6e6oµtvv,v yia tu~ u:861>ou~ ~-r·e~coycni(J(;, £,wt.­ oov UTT6PXOUV oXBT(KIJ. vi) TWV q)UOIKO-XflµIKWV 15tO"fl'jtwV Tll<:: ouo\ac; KG, iG,al­ Tepa rou onµciou 11'\~,,x,:ic; wu onµelou ~lau,!<;. ,n;;;- .:6onr, 01µWv, n1c; emcpove1cKl'}c; 16.vnc;, !flt; uOato610}.m6nrrm;;, rou cuvte~.eott'! Katovoµtic; K-OKTav6>1.nc;/vepou. v1.) rn:v m9avWv o6W.,. µcrnq:iop6:,; o,c, 1µ1'\µc:-ra rnu nept­ ,BWJ,.ovrno:; Kat 1nc; 15uv016T1no<;- npoop6c.p'r)o:1c;/e1<POO)ri­ onc; l(Ol ono11<0Mµncnc;. viii) ·rrir; ouxv6rn101; Kot cnr; 151C'PKt:1or; trK tK8eo11.:;. 3.4. '1a m; ouoie,; rrou t.10K1w· NTai GTTJli oyop6. oe no­ oO"rnm; lm:r; TJ xuµn>.'.in::p£r, TW•' 'O 16vvw·, e111cih:.1,:,; \!'\ 50 r6wwv ouoowpeuTtKO), n ~·EC r, <10,0t1~-t,.; urro.\oy10µ6r; tK8eonr; ouvl'\9w,; KC3opl~ ,,,r,· ;, .-: ro wrnK6 nep1t36AAov mu '1tvouc; oto ono!o c:v' • ·.•c. ·•J unQClit:1 O'l8A£1,Bt pwo,, 1T1c; ouoiac;. 4. XAPAKTHPlrMOI Kn,, "NOY 4.1 r1001061' 0Te i5e1'.H;ptvo tµl'\µa mu nep1l3filovToc;, o xopaKtnp10µ6c; K1vl5 Jvou auven6yern1 OTO µt:Tpo TOU 15u­ votoLi 0DyKp1on Tnc; Pi=C µe Tf)V PNEC olli:wr; Won~ VO elva1 15uvm6 va npoKUme o ,\6yo<;; PEC/PNEC. EO.v o Myo<; PEC/PNEC eivai iCO½ ~ µ11<p6tepoc; tnr; µovMoc;, lO)(Uet TO ouµntpaoµa t0u 6p0pou 3(4)(i). EOV oMyor; elvm µeyo>.U­ n:por; Tilt; µovMcc;, n :::ipµ6151a Apx~ anoq,aol{e1, l36oe11nc; Tlµl'\c; mu Myou KOi 6,V.wv axenK(i)v napay6vt(o)V, 6nwr; 01 1. El81cna1 va xPno1µam>1elt01 &\Joe; owte:.\ecm')c; £Kl~l10Tlt; TT}.; T□~nc; lOU 1000 y10 lTIY ~tµTl L(E)CSO nou npoKUnu:1 on6 TO ono-­ rtltoµOTO Tt.lV OOKlµc,i)V'/!O fllV ~Ela T~!l(6tf1TO, evtollrou;: 0 no­ pClywv out6c; 1-mopel va 1,1e1ti:18el CCII/ ucplotovmt aMec; ovtlot01Xec; n.\11poqioplec;. Xoµ11.\6ti:p01;: ouvte.\ecrn')c; eKllµ11oric; ouvnewc; ecpopµ6~E:TOI VlO TTIV NOEC nou uno.\oy~TO! on6 TO onote>.t­ aµOTQ Tt.lV 00Klj..l!JV Vl{J Xl)6vlO ta~lK6TT}TO. avacpep6µevo1 our; napayp6q>ouc; 1 .1.(ij tc.>r; (iv), :·01 to ouµ;.-;·.:;xioµata tau 6p8pou 3 (4)(iij, Qiij, I') (ivj ,; . , ~, : neplmwon a6uvaµ1m; un0Aov10µ0U -rou ~,,,,. 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