C rpaH a 12 - Epoj 113 CJIY5KEEHH I/ilACHMK P E nyE JIH K E CPÜCKE rioncajcjbaK, 21. aencMoap 2009.

Ha ocHOBy HJiaHa 58. 3aKOHa o npefly3ehnMa ( “ Cayacöe- hh raacHHK PenyöJiiiKe CpncKe” , 6p. 24/98, 62/02, 38/03, 97/04 h 34/06) u HJiaHa 43. cTaß 6. 3aKOHa o BaaaH Peny6an- Ke CpncKe ( “ CayKÖeHH raacHHK PenyÖAHKe CpncKe” , 6poj 118/08), a y Be3H ca OaayKOM o HanHHy HineHOBa&a npea- CTaBHiiKa AKUHjcKor 4>OHfla PenyÖAHKe Cpncxe H OoHqa 3a pecTHTymijy PenyöaiiKe CpncKe y CKymiiTHHaMa apyuiTaBa KanHTaaa io nopTiJiejba (jiOHAOBa h HaraH an xoB or nocry- n aa a ( “ Cay>K6eHn raacHHK PenyöaiiKe Cpncxe” , 6p. 69/07, 102/07 h 45/09), Baaqa PenyÖAHKe CpncKe, Ha cjeaHHqH oa 26. HOßeM6pa 2009. roaiiHe, a o H i i j e a a j e

P J E L U E H j E

O HMEHOBAHjY nPEflCTABHHKA <l>OH/(A 3A PECTH TYU H jy PEnyEJIHKE CPnCKE A/1

I.AH.A JIVKA y CKynUITMHM JIPyillTBA KAnMTAJIA “ KHEUJnOJbETyPHCT” A/I

K03APCKA HYEHLIA

1. HMeHyje ce BaaeHTHHa EpaHKOBiili, annaoMHpaHH Ty- pH3Moaor, 3a npeacTaBHHKa OoHaa 3a pecTirryqqjy Peny- 6anKe CpncKe a.a. E aaa JlyKa y CKynuiTHHH apyurraa xanH- Taaa “ KHemnoibeTypHCT” a.a. KcoapcKa /],y6Hqa.

2. O bo pjeme&e cTyna Ha CHary HapeqHor aaHa oa aaHa o6jaBjtHBaH>a y “ Cay>K6eHOM raacHHKy PenyÖAHKe CpncKe’ .

Epoj: 04/1-012-2-2334/09 npeacjeaHHK26. HOBeM6pa 2009. roaiiHe Baaae,E aaa JlyKa .Vlu.iopaa /Io/ih k , c.p.

2196Ha ocHOBy n aaH a 34. 3aKOHa o xeM M K aan jaM a ( “ C a y »c 6 e -

h h raacH H K P en y6 a H K e C p n c K e ” , 6 p o j 25/09) h n a a n a 82. CTaß 2. 3aKOHa o penyÖ AH H K oj yn paB H ( “ CayH cöeH H raacH H K

Pen yÖ A H K e C p n c K e ” , 6 p . 118/08 h 11/09), MHHHCTap 3 a p a B jta

H COLtHjajlHe 3aiHTHTe J O H O C H

n P A B H J I H H K

O OA/IP'/KAjy UOCHJEA H HAHHHY BOBIIEA EBHJIEHIIHJE O XEMHKAJIHJH

HaaH 1.

Obhm npaBHaHHKOM ypeljyjy ce caapacaj aocnjea o xeMH- Kajinjii h Haara Botjeaa eBiiaeHqiija o xeMsiKaaiijii Koja ce npon3Boan hah yB03H y Peny6aHKy Cpncxy (y aarbeM TeK- CTy: PenyöaiiKa).

HaaH 2.

f lo c H je o xeM H K aanjH n p ea cT a B jb a a oK yM eH T c a n o a a q H -

M a o xeM H K aaq jH K o ja c e y n a c y je y H H B eH Tap xeM H K aan ja , a K o jq p ern c T p a H T n o a H o c q M H H iicT ap cT B y 3apaBA>a h c o q n -

ja a H e 3am TH Te P e n y 6 a q K e C p n cK e ( y q a ib eM TeKCTy: M i ih h -

CT ap cTB o ) npqaH K O M n oA H O H iea a 3 axT jeß a 3a y n u c xeM H Ka-

a n je y H H B eH Tap xeM H K aan ja .

HaaH 3.

(1) /Jociije o xeMHKaanjn caapacn:

a ) H aeHTHTeT n p oH 3 B o l)aa a hah yB03HMKa,

6) H aeHTHTeT cyn cT aH q e ,

b ) n o a a T K e o npoH 3Boafi>H h y n o T p e 6 n H a q yn o T p e 6 a M a ,

naeHTH (j)HKOBaHe o a CTpaH e p e n ic T p a H T a , a K o ju M o ry yK a ,yanB aTH h o a r o B a p a jy h e K a T e r o p q je y n o T p e 6 e u H3aa- ra&a, aK o t o p e rn c T p a m r cM aT p a noTp eÖ H iiM ,

r ) KaacqtjaiKaqqjy u o6Ha>e5KaBaH>e cyncTaHqe,

a ) ynyTCTBO o 6 e3 6 jea H o j y n o T p e ö n cy n cT aH q e ,

1)) pe3HMe CTyailje O (})H3HHKO-XeMHjcKHM, TOKCHKOaO- uiKHM h eKOTOKCHKoaouiKHM noaaqiiMa Kojq cy aecfiHHHcaHH y npnaory 1. o b o t npaBnaHHKa, KojH hhhh aeroB cacTaBHH ano,

e ) caa<eTH o n u c H C T p a »H B a a a 3a n o a a T K e Kojn n p o io n -

a a 3 e H3 n pH M jeu e n p n a o r a 1., a x o c e p a a n o c y n cT a H q n k o -

ja ce n p o ii3 B o a n Han yB03M y k o a h h h h h o a 10 TOHa u Burne,

ac) H 3jaßy c T p y n a a K a (K o jq n o c je a y je o a r o B a p a jy h e n c x y -

c t b o u K o jii j e HMeHOBaH oa CTpaHe n p oH 3 B o l)aa a H au yBO- 3HHKa) K o je n o a a T K e H3 o b o t cTaß a je n p e ra e a a o ,

3 ) n p H je a a o r e H c m iT H B a a a a ico c y H aB eaen n y n p n a o r y 1., o a je a > a x B 11 F,

h ) HH(j)opMaqHje o H3aoaceHOCTH 3a cyncTaHqe Koje ce npon3Boae Hau yB03e y k o a h h h h h oa 100 KnaorpaMa ao 10 TOHa H

j ) 3axT jeB y Be3H ca n o a a q u M a 3a K o je n p o n 3 B o l)a a H au

yB03HHK CM aTpa a a He 6 h T p e 6 a a o a a 6yay a o c T y n H ii ja B H o - c th , yK Ab yn yjy liH 11 o 6 p a 3 a o > K e a e 3auiTO 6h o6 jaB A >H B aae

6 h a o uiTeTHO n o a e r o B e n oca o B H e H H Tepece h a h H H Tepece 3aH H TepecoBaH H x cTpaH a.

(2 ) P erH CTpaH T j e a y ^ a H n oc je a o ß a T H n oT n yH H 3B jeuiTaj

o C T ya n jn Ha x o jy ce o a H o c e pe3HM e h c a * e T a K c r y a n je 113 CTaßa 1. T. 1)) 11 e ) O B or a a aH a m m nwcMO n p u c T y n a a o x y M e H -

T a q H jq K o ja j e BaacHHuiTBO a p y r o r a n q a .

H a a H 4.

(1 ) CaaceTax aocujea npeacTaBa>a H3Boa 113 aocqjea o xe- MHxaaqjH Kojq perncTpaHT aocTaBiba 3a cyncTaHqy xoja je peracTpoBaHa y EßponcKoj yHHjn (E Y ) n a « je nocTynaK pe- rucTpaqHje y TOKy.

(2) Ca>KeTaK a o c n je a c a a p x a i:

a ) HaeH TH TeT n p oH 3 B o t)a q a nun yB03HHKa,

6) HaeHTHTeT cyncTaHqe,

b ) n o a a T K e o n p o H 3 B o a a n h yn oT p eÖ H h a h y n o T p e ö a M a ,

HaeHTH(j)HKOBaHe o a CTpaHe p e rn c T p a H T a , a K o ju M o ry yKa>ynHBaTH h o a r o B a p a jy h e K a T e ro p n je y n o T p e ö e n H3aa-

r a a a , aKO t o p e rn c T p a H T CM aTpa noTpeÖ H H M ,

r ) KaacH cjjH K aqu jy h o6HJbe>KaBaH>e c y n c T a n q e ,

a ) ynyTCTBO o 6e36jeaHoj y n o T p e 6 n cy n cT aH q e ,

5 ) pe3HMe CTyanje 3a noaaTKe Koju npon3Haa3e H3 npn- MjeHe rip n ao ra 1.,

e ) H H (})op M aqH je o H3aoxceHOCTH 3 a cy n c T a H q e K o je ce

n p oH 3 B oae h a h yB 03e y k o a h h h h h oa 100 K n a o rp a M a a o 10 TOHa H

jk) 3axT jeB y Be3H c a n o a a q H M a 3a K o je n p o it3 B o t )a q h a h yB03HHK CM aTpa a a He 6 h T p e ö a a o a a 6 y a y a oc T yn H H jaBHO- c t h , yK A ,yq y jy h H h o6pa3A05KeH>e 3auiTO 6 h o6jaBA>HBaH,e

6 h a o n iTeTHO n o H>eroBe n oca o B H e H H Tepece iu ih H H Tepece 3aH H TepecoBaH H x CTpaHa.

H a a H 5.

( 1 ) Pe3H M e C T yan je 11 caaceTH o n n c H C T p aaa iB a& a H3 a o -

cu je a o x e M iiK a a n jn T p e 6 a a a caapacn cBe 6 iiT H e h p e rn -

CTpaH Ty aO CTynH e 4)H3HHKO-XeMHjCKe, TOKCHKOAOUIKe H eKO- TOKCHKOAOuiKe n o q a T K e H aBeaeH e y n p n a o r y 1., y 3aBHCHO-

c t h o a KOAHHHHe, a H a jM a& e CA>eaehe:

a) noaaTKe HaBeaene y oajeA>Ky A 3 a cyncTaHqe Koje cy npoH3BeaeHe h a h yBe3eHe y KOAHHHHaMa oa HajMaae 100 kh - aorpaMa no npoH3Bol)aHy h a h yB03HHKy Ha roaHm aeM h h - Boy,

6 ) n o a a T K e H aBeaeH e y o a je a jq u M a A 11 E 3 a cy n cT a H q e npoH 3 B eaeH e h a h yße3eH e y K O A iianH aM a o a H a ja M fte 10 t o -

Ha n o n p on 3 B o l)a H y h a h yB03HHKy n a r o a n n if t e M HHBoy,

b ) n o a a T K e H aBeaeH e y o a je a ,q H M a A 11 E 11 n p i i je a a o r e H cn H T H B aaa 3a 3axT jeB e H aBeaeH e y oa jea>K y B 3a c y n cT a H q e

npoH 3 B eaeH e h a h yB e3en e y KOAHHiiHaMa o a H a jM a a e 100 t o - Ha n o n p oH 3 B o tja a y h a h yB03HHKy Ha r o a n u if t e M H im o y H

r ) n o a a T K e H aBeaeH e y oajeA^aH M a A 11 E h n p H je a a o r e

H cro iT H B a fta 3 a 3axT jeß e H aBeaeH e y o a je a jq u M a B 11 T 3a c y n ­

cT a H q e npoH 3 B eaeH e h a h yBe3eHe y K o a n a n n a M a o a H a jM a a e 1.000 T o n a n o n p oH 3 B o t)a q y h a h yB03HHKy Ha r o a n n ia e M h h - Boy.

(2 ) Y CAyaajy a a KOAHHiiHa cyncTaHqe no npoH3Bol)aHy h a h yB03HHKy Koja je npeTxoaHO perncTpoßaHa aocTHrHe KOAHAHHy Koja peFHCTpaHTa CBpCTäBa y BHUiy KOAHHHHCKy rpyny, npoii3Bo5an h a h yB03HHK Mopa oaMax o6aBnjecTHTH MiiHHCTapcTBO o aoaaTHHM noaaqHMa Kojn ce 3axTHjeBajy y CTaBy 1. OBor HAäHa.

JloHeajeibaK, 21. aeqeMÖap 2009. CJTy)KEEHH rJTACHHK PEnyEJIHKE CPnCKE Bpoj 113 - CTpaHa 13

HaaH 6.

noaaqH o HfleHTHTeTy perHCTpaHTa noapa3yMHjeBajy:

a ) H33HB, aapecy, 6poj TeaeijiOHa, 6poj TeaetjiaKca, eaea- TpoHcxy aapecy,

6 ) noaaTKe o KOHTaxT a n q y h

b ) a o x a q q jy hah A o x a q q je Ha xojHM a peracTpaH T np o- H3Boan hah xopHCTH cyncTaHqy.

MaaH 7.

noaaqH o HaeHTHTeTy cyncTaHqe noapa3yMHjeBajy:

a) ea3HB hah apyry HaeHTmjjHKaqnoHy 03Haxy cBaxe cyncTaHqe:

1) Ha3HB hah Hä3HBe cyncTaHqe no IU PA C HOMeHxaaTy- p q HAH HeKH a p y ra MeljyHapoaHH Ha3HB hah Ha3HBe,

2) ocTaae Ha3HBe xao niTO cy yo6nqajeHH Ha3HB, Tpro- BaaKH Ha3HB, cxpaheHHqa,

3) 6poj H3 Eßponcxor HHBeHTapa nocTojelmx TproBaq- khx cyncTaHqH (European Inventory o f Existing Commercial Chemical Substances - E IN E C S ) hah 6poj H3 Eßponcxe ancTe hobhx TproBaaKHX cyncTaHqH (European List o f N otified Commercial Chemical Substances - EL1NCS), axo cy aocTyn- hh h noTpeGmi,

4) C A S (Chemical Abstract Service) Ha3HB h C A S 6poj, axo je aocTynaH;

6) HHcjiopMaqqje Be3aHe 3a MoaexyaapHy h CTpyxTypHy (jiopMyay CBaxe cyncTaHqe:

1) MoaexyaapHa h cTpyxTypHa (jiopMyaa,

2) noaaqn o onTnqxoj axTHBHOCTH h yo6qqajeHOM oaho- cy (cTepeo) H30Mepa, axo je npHMjemiiBO h noTpeÖHO, .

3) MoaexyaapHa Maca hah pacnoH MoaexyaapHe Mace;

b ) cacTaB CBaxe cyncTaHqe:

1) npoqeHaT HHCTohe (% ),

2) npnpoaa HequcToha, yKA>yqyjyhH h H30Mepe h Hyc- npon3Boae,

3) npoqeHaT raaBHHX HeancToha,

4) npnpoaa h pea BeaiwHHe (ppm, % ) 6hao xo jer aaHTH- Ba (Hnp. cTa6nAH3aTopa hah HHxn6nTopa),

5) cnexTpaaHH noaaqH (yATpajby6nqacTH, HHcjipaqpBe- hh, HyxaeapHH MaraeTH0-pe30HaHTHH hah MaceHH cnexTap),

6) XpOMaTOTpaMH ao6njeHH BHCOXOnpHTIICHOM TeHHOM hah racHOM xpoMaTorpaijiHjoM,

7) onuc aHaaHTHHKHX MeToqa hah oaroBapajyhn noaaqn H3 AHTepaType 3a naeHTHijiHKaqHjy cyncTaHqe h , raje je to noTpe6Ho, 3a HaeHTH(J)HxaqHjy HeqHCToha h aanTHBa Ha ocHOBy xojer je Moryhe noHOBimi aHaaH3y.

HaaH 8.

n oaaqn o npoH3BOAHbH h ynoTpe6n hah ynoTpe6aMa cyncTaHqe cy:

a) yxymra npoH3BoaH,a, xoanquHe ynoTpnje6A>eHe y npoH3Boaq>n npoH3Boaa xojn noaaHjerxy ynncy y HHBeHTap h / hah yBe3eHe xoAnqiiHe y TOHaMa no perHCTpaHTy Ha roAHiinbeM HHBoy y xaaeHaapcxoj roanHH ynnca (npoqnje- meHa xoAHHHHa),

6 ) KpaTax onuc TexHoaomxor npoqeca npoH3Boaae npo- H3Boaa xojn aocTaBA>a npoH3Boi)aq npoH3Boqa,

b) noaaTax o xo aiiah h h ynoTpujeöJbeHoj 3a BaacTHTe no- Tpe6e,

r ) noaaTxe o AHCTpnGyTepHMa hah xpaj&HM xopucHHqu- Ma xojHMa je xeMnxaanja HcnopyqeHa h xoAHHHHa Hcnopy- aeHe xeMHxaanje Ha roanuifteM HHBoy,

a ) oSahx (cyndaHqa, npenapaT iuih npoH3Boa) h / hah cJdm- 3HHX0 CTame y xojeM je cyncTaHqa aocrynHa xpajmeM xopn- CHHxy, xoHqeHTpaquja hah xoHqeHTpaqiioHH pacnon cyncTaH­qe y npenapaTy aocrynHOM xpajmeM xopucHHxy h xoAHHHHe cyncTaHqe y npoiBBoqy aocrynHOM KpajmeM xopucHHxy,

1)) KpaTax yonurreH onnc naeHTHcjiHKOBaHe ynorpe6e,

e) noaaqn o k o a h h h h h h cacTaBy om aaa xojn HacTaje npoH3BoaH>oM cyncTaHqe, ynoTpe6oM y npoH3Boay h naeH- THija-ixoBaHOM ynoTpe6oM h

ac) ynoTpe6e Koje ce He npenopyqyjy.

H a a H 9.

K aacH cjtH xaqH ja h o6iiA>e>xaBaH>e c y n c T a H q e B p m n ce y

c x a a a y ca 3axoH O M o x eM n xa a n ja M a .

H a a H 10.

(1 ) yn yT C TB O o 6 e3 6 jeq H o j y n o T p e 6 n c y n c T a H q e M o p a o6e36H jeaH T H n o a a T x e x o jn c y y CK Aaay ca n o q a q H M a y 6e- 36 jeaH O C H O -TexH nqxoM AHCTy ( y aaa>eM T ex cT y : ETJI), x a a a ce o h 3axTH jeBa.

(2) n o a a q n H3 ETJI n oT p e6 H H y c x a a a y c a CTaBOM 1. OBor a a a H a cy :

a ) Mjepe npBe n o M o h n ,

6 ) M jep e 3a cy 3 6 H ja & e noacapa ,

b ) M jep e y c a y q a jy a x q q a e H T a H a c T a a o r H c n y m T a a e M x e - M H xaaH je ,

r ) H H tjiop M aqu je o H aqH H y p y x o B a m a , yn o T p e G e h cx n a - a H ff lT e fta h

a ) H H tfjopM aqu je o 6e36jeaH O M H aqH H y T p a H cn o p T a .

(3 ) A x o 3a xeMiixaaiijy Hiije noTpeSHO aocTaBHTH H3Bje- mTaj o 6e36jeaHocTH xeMHKaaHje, noTpeGHO je aocTaBHTH ii ca.eaehe noaaTxe H3 ETJI:

a ) H a q 3 op H aa H 3no>xeH om hy h AH qH a 3am TH Ta,

6 ) CTa6HAHOCT H peaXTHBHOCT H

b ) H H ijiop M aqu je o o a a a r a i t y .

H a a H 11.

Pe3H M e C T yan je n oap a3 yM H jeB a cxp ah eH H n p n K a3 qHA>e- Ba, M e T o a a , p e 3 y A T a T a h 3 a x a > y q a x a x o M n a e T H o r

HCTpaacHBama, K o jn o 6 e 3 6 je l)y je a o b o a >h o H H tjiopM aqH ja a a

6 h c e y p a a n a a n p o q je H a peaeBaTHOCTH C T yan je , a o a h o c h ce

Ha n o a a T x e a o 6 q je H e Ha ocH O By n p n a o r a 1., y 3aBHCHOCTH

o a xoAHAHHCKe rp y n e .

H a a H 12.

CaaceTH o n n c n cTpaacH B a fta 03H aqaB a a eT a a ,a H pe3HM e

qH A .eBa, M eT oa a , p e3 ya T a T a h 3 a x a ,y q a x a n o T n y H o r H3Bje-

m T a ja o c T y a n jn x o jH a a je a o b o a j HO H H ijjop M aqH ja a a 6 h ce a a a a He3aBHCHa o q je H a C T yan je , y3 CM am erbe n o T p e 6 e 3a x o h -

cy A T O B a a eM n o T n y H o r H 3B jem Taja o C T yan jn , a o a H o c n ce Ha

n o a a T K e a o 6 n je H e Ha ocH O By n p n a o r a 1., y 3aBHCHOCTH o a xoAH quH C K e rp y n e , yKOAHKO j e 3axTn jeBaH n p oq jeH O M o

6e36jeaH 0CTH x eM n x a a n je .

H a a H 13.

P e ra c T p a H T aocT a B A ,a M iiH H c ra p c T B y n p u je a a o r H cnu -

TH B am a cy n c T a H q e a x o c e cy n cT aH q a n p o n 3 B o a n h a h yB03H

y K o a n q iiH a M a o a 100 T o n a h a h BHiue n o n p oH 3 B o l)a q y h a h yB 03H H xy Ha ro a n m & e M HHBoy, y c x a a a y ca o a je a ,q H M a B h

T n p n a o r a 1.

T inaH 14.

(1 ) H o B a HcnHTHBam a 3a oap e ijH B a ib e n oa a T a K a HaBeae-

h h x y n p a a o r y 1. c n p o B o q e ce T a x o a a ce H cnuTH Bam a Ha

KH AM em aqnM a H 3 6 je rn y h a h CBeay Ha H a jM am y M o ry h y M jepy.

(2) H o B a ncnH TH Bam a Hehe c e cnpoBoaHTir:

a ) aK o H n je H a yu n o HeonxoaHo,

6) a x o n o c T o jn aoB oa>aH 6 p o j a o c T y n m ix in v it r o h in v i ­vo n o a a T a x a ,

b ) axo nocTojn aoBoa,aH 6poj aocTynm ix HCTopHjcxnx xyMaHiix noaaTaxa,

r ) a x o n o c T o jn aoB oa>aH 6 p o j aocTyn H i-ix n o a a T a x a o cpoAH H M rp y n a M a ((Quantitative) Structure-Activity R e la t io n ­

sh ips - (Q )S A R s),

a ) axo nocTojn aoBoa,aH 6poj aocTynHHX noaaTaxa a o -

6njeHHx o cTpyxTypHo noBe3aHHM cyncTaHqaMa h

1)) axo HHje TexHHHKH h 3b o a a >h b o 36or npupoae cyncTaH­qe.

CTpaHa 14 - Bpoj 113 CJBOKEEHH TJIACHHK PEnyEJIHKE CPnCKE noHeajejbax, 21. aeqeM6ap 2009.

(3 ) Koa cyncTaHqH xoje ajeayjy k o p o 3h b h o H36jeraBahe ce in vivo ncnHTHBaita y KOHqeHTpaqiijH xoja H3a3HBa xopo- 3HBH0CT.

H a a H 15.

n p 0 H 3 B 0 tjaq HAH yB03HHK K o jll npOH3BOflH HAH yB03H

cy n c T a H iiy y x oA H qn H aM a o a 100 K H a o rp a M a a o 10 TOHa Ha

r o a n a i f t e M HHBoy aocTaB Jba H H cjjopM aqu je o o m a a y x o jn

H acT a je y n o T p e 6 o M xeM iixaA J ije h H H ijiopM aqH je o H3AO»<eHo-

c t h xeM H K aanjH 3a:

а) KaTeropnjy raaBHe ynoTpeGe xeMMKaanje, h to :

1) HHaycTpujcxa ynoTpe6a, npotjiecHOHaAHa ynoTpeGa h a h ynoTpeGa oa CTpaHe noTpouiaaa,

2) aeTaa>aH o n n c H H A yc rp H jcx e h a h n poijiecH O H aAH e y n o -

T p e 6 e (y n o T p e 6 a y 3aTBopeH H M CHCTeMHMa, y n o T p e 6 a x o ja

npoH3HAa3H H3 yxA>yqeH>a y h a h Ha M aT p n xc , p a c n p m y jy h a

h a h H e p a c n p o iy jy t ia y n o T p e 6 a );

б ) 3H aaajH e n yTeB e H3AaraH>a xeM M K aan jn , h t o :

1) H3AaraH>e a>yaH (opaaHo, aepMaAHo, yancaibeM),

2) H3aaraH>e >XHBOTHe cpeauHe (Boaa, Ba3ayx, 3eMA>HHITe),

3) y q e c T a a o c T H3aaraH>a (cn yq a jH O / pu jeTK O , n oB p eM e-

h o , KOHTHHynpaHO / a e c T o ).

HaaH 16.

(1 ) PerncTpaHT je ayJxaH b o a h t h eBHaeHquje o c b h m

H3MjeHaMa n oaaTaxa HaBeaeHHX y a ocu jey , xa o h eBiiaeHqH- je o h o b h m ca3HaibHMa a o x o jn x aotje.

(2 ) H 3 M jen e noaaTaxa H3 CTaßa 1. o b o t qaaHa oaH oce ce Ha npoMjeHe o CTaTycy ripaBHor A iiqa , cacTaBy cyncTaHqe, ro a H fflfto j h a h yxynH oj x o a h h h h h cyncTaHqe x o ja je npo- H3BeaeHa h a h yBe3eHa h a h y x o a h h h h h cyncTaHqe npncyTne y npoH3Boay, HOBe HaeHTii(J)qxoBaHe yn oTpe6e h HOBe yno- TpeGe x o je ce He n p en op yqy jy , HOBa ca3HaH>a o p iisn xy c y n ­cTaHqe no 3apaBibe A>yan h / h a h JXHBOTHy epeanny. npoxije- He y xaacH ^H Kaqu jii h oGiUbeacaBaiby cyncTaHqe, Te noaamt- Ma xo jn M ory 6 h th aocTynHH jaBHOCTH.

(3 ) AjxypupaHH noaaqn aocraBJbajy ce MriHHCTapcTBy, xoje npoßjepaBa noTnyHOCT noaaTaxa h ibHXOBy ycxaalje- h o c t ca qaaHOM 5. o b o t npaBHAHHxa.

HaaH 17.

Oßaj npaBHAHHx CTyna Ha cHary o c m o t aaHa oa aaHa o6jaBA>HBaH,a y “ Cay>x6eHOM raacHHxy PenyGauxe Cpncxe” .

E p o j: 11/07-020-31/0930. HOBeMGpa 2009. ro a u H e M iiH H C T ap ,Eam a J lyxa U p P a H xo LLlKp6nti, c.p.

n p n aor 1.

OH3HHKO-XEMHJCKH, TOKCHKOJIOinKH H EKOTOKCnKOJIOUIKH nO/IALIH 3A CynCTAHIIE A - c y n c T a H q e npoH 3 B eaeH e h a h yBe3eH e y xoaH A H H aM a o a 100 x n a o rp a M a h a h B iim e

1. nO/IALIM o OH3HHKO-XEMHJCKHM OCOEHHAMA CynCTAHLjEKOJIOHA 1.

C TAH U AP/IH H 3AXTJEBHKOJIOHA 2.

nO C E E H A n PA B H JlA 3A O U C T y n A ü E 0/3, KOJIOHE 1.1.1 ArperaTHO c raa e cyncTaHqe npn 20°C h 101,3 kPa

-

1.2 Taqxa Tonn>eiba / Mpxcibeiba 1.2 HcTpaxtHBafte Hnje noTpeÖHO cnpoBoanTH ncnoa AOH>e rpaHnqe oa -20CC.1.3 Taqxa xa>yqaH.a 1.3 HcTpaxniBafte Hiije noTpeÖHo:

- 3a racoBe h a h

- 3a qBpcTe cyncTaHqe xoje HMajy Taqxy Tona>eiba H3Haa 300°C h a h ce pacnaaajy npuje XA>yqaH>a. y t o m cayqajy Moace ce npoqujeHHTii h a h H3MjepHTH Taqxa xjbyqa&a noa cmiJxeHHM npnTHCKOM h a h

- 3a cyncTaHqe xoje ce pacnaaajy npuje Taqxe XA>yqaiba (Hnp. ayTooxcnaaunja, nperpaa&a, pa3rpaafta, jiacn aaaae , h t a .).

1.4 PeaaTHBHa rycTHHa 1.4 HcTpa>XHBaH>e Hiije noTpeGHO axo:- je cyncTaHqa CTaGHAHa caMO y pacTBopy ca oapeljeHHM pacTBapaqeM h a x o je rycTHHa pacTBopa canqHa rycTHHH pacTBapaqa. y t o m cayqajy a o b o a .h o je HaBecTH aa a h je rycTHHa pacTBopa Beha h a h Matba oa rycTime pacTBapaqa h a h

- je cyncTaHqa rac. y t o m cayqajy npoqjeHa ce 6a3Hpa Ha H3paqyHaBaH>y Ha ocHOBy MOAexyaapHe Mace raca h 3axoHa naeaaHor raca.

1.5 HanoH nape 1.5 HcTpajxiiBafte Hiije noTpe6Ho axo je Taqxa Tona>eH>a H3Haa 300°C.A x o je Taqxa Tona>eH>a H3Meljy 200°C h 300°C, aoBonmo je HaBecTH rpaHiiqHy B_pnjeaHOCT ao6njeHy MjepeaeM h a h npii3HaTOM paqyHcxoM MeToaoM.

1.6 nOBpUIHHCXH HanoH 1.6 HcTpaxaiBaibe je noTpe6HO caMO axo:- ce Ha ocHOBy CTpyxType oqexyje, oaHOCHO npeaBnlja noBpuiHHCxa 3k t h b h o c t

HAH- je noBpuiHHcxa axTHBHocT 5xeajeHO cBojcTBo MaTepujaaa.HcTpaaoiBafte Hiije noTpeGHO axo je pacTBopa>HBOCT y b o a h M aaa o a 1 mg/L nPH 20°C.

1.7 PaCTBOpjbHBOCT y BOAH 1.7 HcTpaacuBafte Hiije noTpeGHO axo:- je cyncTaHqa x h a p o a h th a k h HecTa6HAHa npn pH 4,7 h 9 (BpujeMe noaypacnaAa Hcnoa 12 qacoBa) h a h- cyncTaHqa aaxo oxcnayje y b o a h .

A x o ce qiiHH aa je cyncTaHqa “ HepacTBopHa” y b o a h , Tpe6a oGaBHTii rpaHHqffli TecT a o rpaHnqe aeTexquje aHaaiiTHqxe MeToae.

1.8 KoefjuiqujeHT pacnoajeae n-oxTaHoa/Boaa

1.8 HcTpaAciiBafte Hiije noTpeÖHO axo je cyncTaHqa HeopraHcxa. A x o ce HcnuTMBa&e ee Moixe cnpoBecra (Hnp. cyncTaHqa ce pacnaaa, HMa Beanxy noBpmnHCxy a x t h b h o c t , GypHO pearyje 3a BpnjeMe ncniiTHBaiba h a h ce He pacTBapa y b o a h h a h oxTaHoay h a h axo Huje Moryhe nocTHhn 3aAOBOJbaBajyhy qncTohy cyncTaHqe), noTpeGHO je HaBecTH H3paqyHaTy BpqjeaHOCT 3a log P, xao H aeTaa>e o paqyHcxoj MeToan.

1.9 Taqxa naajeiba 1.9 HcTpaaaiBaibe Huje noTpe6HO axo:- je cyncraHqa HeopraHcxa h a h

- cyncTaHqa caapacn caMO HcnapibHBe opraHCxe xoMnoHeHTe c TaqxoM najbeiba

FIoHeajejbaK, 21. aeqeMGap 2009. CJiy)KEEHH rJIACHHK PEnyEJIHKE CPnCKE Epoj 113 - CTpaHa 15

H3Haa 100°C 3a BoaeHe pacTBope h ah

- je npouHje&eHa Taqxa naA>eH>a H3Haa 200°C hah

- ce Taqxa naA>eH>a MO>xe TaqHO npeaBnajeTH HHTepnoaaqiijoM Ha ocHOBy nocTojeliHX cyncTaHqH no3HaTHX ocoÔHHa.

1.10 3anaibHBOCT 1.10 HcTpaxcuBafte HHje noTpeÔHo:- 3a qBpcTe cyncTaHqe xoje HMajy excnA03HBHe h ah nupotjiopHe ocoÔHHe. Te ocoSiiHe Tpe6a yBnjex pa3MOTpHTH npqje 3anaa>HB0CTH hah

- 3a racoBe, axo je xoHqeHTpaquja 3anan,iiBor raca y cMjecn ca HHepTHHM racoBHMa Taxo Hncxa aa xoa Mujemaita ca Ba3ayxoM cTaaHo ocTaje ncnoa aofte rpaHHqHe BpnjeaHOCTH h ah

- 3a cyncraHqe xoje cy caM03anan>HBe y aoaupy ca Ba3ayxoM.1.11 EKcnao3HBHe ocoGriHe 1.11 HcTpa5KHBaK.e Hiije noTpeÔHo:

- axo y MOAexyAy HHcy npncyTHe xeMHjcxe rpyne xoje ce noBe3yjy ca excnao3HBHHM ocoÔHHaMa h ah

- axo cyncTaHqa c aap *H xeMiijcxe rpyne xoje ce noBe3yjy ca excna03HBHHM ocoÔHHaMa, yxA>yqyjytiH xnceoHHX, a H3paqyHaTH 6naaHC xnceoHiixa je Ma&H oa -200 HAH- axo opraHcxa cyncraHqa h ah xoMoreHa cMjeca opraHcxnx cyncTaHqn caap^xn xeMHjcxe rpyne xoje ce noBe3yjy ca excnA03HBHHM ocoGimaMa, aAH je er30TepMHa eHeprnja pacnaaa& a M aaa oa 500 J/g h er30TepMHO pacnaaaite 3anoqiiH>e Ha TeMnepaTypH ncnoa 500°C hah

- xoa CMjeca HeopraHcxnx oxcnaaTHBHHX cyncTaHqH (noapa3pea U N 5.1.) ca opraHCXHM MaTepujaaiiMa, axo je xoHqeHTpaqnja HeopraHcxe oxcnaaTHBHe cyncTaHqe:- Mama oa 15% MaceHor yajeaa, y cayqajy pa3BpcTaBa&a y U N rpyny n axo B aaa I (Beanxa onacHOCT) h ah II (cpea& a onacHOCT),- Mama oa 30% MaceHor yajeaa, y cayqajy pa3BpcTaBaH>a y U N rpyny naxoBama III (M aaa onacHOCT).HanoMeHa: A x o je er30TepMHa eHeprnja pacnaaarta opraHcxe cyncTaHqe MaH>a oa 800 J/g, HHje noTpeÔHO cnpoBoanTH HcnuTHBaae m npefta excnao3Hje hhth ocjeTAîHBOCTH Ha yaapHH Taaac.

1.12 TeMnepaTypa caM03anarbiiBocTH 1.12 HcTpajxHBatbe HHje noTpeÔHo:- axo je cyncTaHqa excnao3HBHa hah caM03anaa>HBa y aoau py ca Ba3ayxoM Ha coSHoj TeMnepaTypH hah

- 3a TeqHocTH xoje HHcy 3anaa>HBe Ha Ba3ayxy, Hnp. Taqxa naa>eH>a H3Haa 200°C HAH- 3a racoBe xojn HeMajy noapyqje 3anaa>HBOCTH h ah

- 3a qBpcTe cyncTaHqe axo cyncTaHqa HMa Taqxy Tona>eH>a <160°C h ah axo npeAHMHHapHH pe3yATaTH Hcxa>yqyjy caM03arpHjaBaH>e cyncraHqe Ha TeMnepaTypaMa ao 400°C.

1.13 OKCHflaTHBHa CBojCTBa 1.13 Hcrpa>XHBaH>e HHje noTpeÔHo axo:- je cyncTaHqa excnao3HBHa hah

- je cyncTaHqa aaxo 3anan>HBa hah

- je cyncraHqa opraHcxn nepoxcua hah

- cyncTaHqa HeMa cnocoGHOCT er30TepMHe peaxquje ca 3anaji>HBHM MaTepnjaAHMa, Ha npHMjep Ha ocHOBy xeMHjcxe CTpyxType (Hnp. opraHcxe cyncTaHqe xoje He c a a p »e xnceoHHx h aii aTOMe xaaorena h th eaeMeHTH HHcy xeMHjcxH Be3aHH Ha a30T hah xnceoHHX hah HeopraHcxe cyncTaHqe xoje He caap>xe xnceoHnx H aTOMe xaaoreHa).K o a qBpcTHX cyncTaHqa HHje noTpeÔHo cnpoBoaHTH noTnyHO HcnHTHBarte axo je npeaHMHHapHO HcnHTHBame jacHo noxa3aao aa HcnuTHBaHa cyncTaHqa HMa OXCHAATHBHa CBojCTBa.Tpe6a HanoMeHyTH aa He nocTojn HcnHTHa MeToaa 3a oapeljHBaae oxcHaaTHBHHX CBojcTaBa racoBHTHX CMjeca; Ta CBojcTBa Tpe6a ounjeHHTH xopHCTeliH MeToay npoqjeHe Ha ocHOBy nopeljerba oxcnaaTHBHor noTeHqajaaa racoBa y CMjecn c o xchaath bhh m noTeHqHjaaoM xnceoHHxa H3 Ba3ayxa.

1.14 TpaHyAOMeTpHja 1.14 HcTpaacHBaae HHje noTpeÔHO cnpoBoaHTH axo ce cyncTaHqa CTaBA»a y npOMeT HAH XOPIICTH y HeqBpCTOM HAH 3PHBCTOM oGAHXy.

2. TOKCHKOJIOLUKH nO/3AU,H

KOJIOHA 1. CTAH JIAPZIH n 3AXTJEBH

K O J IO H A 2.nO C E E H A nPAB H JIA 3A O /ICTYnAIBE O/I KOJIOHE 1.

2.1 Haapa>XHBaH.e iu ih HarpH3aH>e xo?xeO u je ftH B aite OBe xpajm e Taqxe ce cacTojn H3 ca>eaeliHX xop axa :(1) oqjeHjHBaH.e pacnoAoxaiB nx n oaaTaxa o Jhyjxuua. n jxHBOTHH»aMa,(2) oqjeH,HBaH>e xnceae h a h aaxaaH e

pe3epBe,(3) in vitro HCTpaixuBame HarpH3ajyher ajeAOBaH>a Ha xœ xy,(4) in v itro HCTpax<HBaH.e Haapa>xyjytier a jeaoB aiba Ha xoixy.

2.1 K o p a qn (3) h (4) HHcy noTpe6HH axo:- pacnoaoACHBe HHcjiopMaquje yxa3yjy Ha t o aa cy ncnytbeHii xpHTepnjyMH npeMa xojHMa ce cyncraHqe pa3BpcTaBajy xao Harpii3ajyhe 3a xoacy h a h Haapaacyjytie 3a OAH HAH- je cyncTaHqa 3anaa>HBa Ha Ba3ayxy Ha co6Hoj TeMnepaTypH h a h

- je cyncraHqa pa3BpcTaHa xao Bpao oTpoBHa y aoau py c xo jxo m h a h

- xoa HCTpaaaiBaiba axyTHe aepMaane t o x c h a h o c t h HHje yTBpljeHO Haapa5xyjyhe ajeaoBaH>e Ha xoacy a o rpaHHqHe ao3e (2.000 mg/kg TjeaecHe Tem iH e).

CTpaHa 16 - Epoj 113 CJIYJKBEHH rJIACHHK PEFIYEJIHKE CPFICKE noHcaje-bax, 21. aeuc.MOap 2009.

2.2 HaapaacHBaEbe oqq jy OnjetbHBaae oBe xpajme Taqxe ce cacTojn H3 cjbeaehnx KopaKa:(1 ) onjeftHBafte pacnoao>KHBHX noaaTaxa o A>yaHMa h >KHBOTHH>aMa,(2) yTBpl)HBaH>e xnceae hah aaxaaHe pe3epBe,(3) in vitro HCTpamiBa&e H aapa*yjyher aieaoBaiba Ha o ah .

2.2 K opax (3) HHje noTpe6aH axo:- pacnoao*HBe HH(j>opMaqHje yxa3yjy Ha t o aa cy ncnytbeHH xpHTepnjyMH npeMa xojHMa ce cyncTaHqe pa3BpcTaBajy xao Harproajyhe 3a xo>xy hah Haapaacyjyhe 3a ohh hah- je cyncTaHqa 3anaa>HBa Ha Ba3ayxy Ha co6Hoj TeMnepaTypH.

2.3 CeH3H6HAH3aqHja xoace OujeHjHBaHbe OBe xpajme Taqxe ce cacTojn H3 cA>eqehHX xopaxa:(1 ) ODjeftHBaae pacnoaoACHBHX noaaTaxa o JbyaHMa h ACHBOTHHbaMa h aATepHaTHBHiix noaaTaxa,(2) in v ivo HcnHTHBaite.

2.3 K opax (2) HHje noTpe6aH axo:- pacnoaoacHBe HHijiopMaqHje yxa3yjy Ha to aa cyncTaHqy Tpe6a pa3BpcraTH c oi)3HpoM Ha H3a3HBaH>e ceH3H6HAH3aqnje xoace hah HarpH3aH>a xo>xe ruin- je cyncTaHqa jaxa xnceaHHa (pH <2,0) hah 6a3a (pH > 1 1,5) hah

- je cyncTaHqa 3anaa.HBa Ha Ba3ayxy Ha coGHoj TeMnepaTypH.M eToaa H36opa in v ivo HcnHTHBaaa je aoxanHa aHaaroa ah m 4>hhx qBopoBa MHtneBa (LLN A ). H pyra HcnHTHBaaa TpeGa xopucTHTH caMO y H3y3eTHHM oxoAHOCTHMa. 3a KopHinheite apyre MeToae je noTpe6Ho aocTaBHTH o6pa3AO>xeH>e.

2.4 MyTareHOCT2.4.1. In vitro HcnHTHBa&e reHCKHX MyTaqnja GaxTepnja

2.4 Y cayqajy no3HTHBHor pe3yaTaTa, Tpe6a pa3MOTpHTH MoryhHOCT cnpoBoljeiba apyrnx HCTpa>KHBaH,a MyTareHocTH.

2.5 AxyTHa tokchahoct 2.5.1. OpaAHa npHMjeHa

2.5 HcTpa>KHBaH,e oahocho HCTpa>XHBaH>a reHepaAHO HHcy noTpeGHa axo:- je cyncTaHqa pa3BpcTaHa xao Harpraajyha 3a xoacy.HcTpaACHBaae HHje noTpe6HO cnpoBoaHTH axo je aoerynHa CTyanja o axyTHoj HHxaaaqHOHoj tokchahocth (oa ie jtax E, Taqxa 2.5.2.).

3. EKOTOKCHKOJIOEIKH I IO/IAHHKOJIOHA 1.

CTAHflAP/IHH 3AXTJEBHKOJIOHA 2.

nOCEEHA nPABHJIA 3A OflCTYnAiBE OH KOJIOHE 1.3.1 T o k c h a h o c t y b o a h

3.1.1. H cn H TH B a ibe xpaTK O Tpa jH e

t o k c h a h o c t h Ha G ecxH A M eibaqH M a (n p e tjtep u p a H a B pcTa D a p h n ia )

P e rn c T p a H T Moace yM jecTO xpaTK O Tpa jH e t o k c h a h o c t h HcnHTaTH

A y r o T p a jH y t o k c h a h o c t .

3.1.2. H H X H Ô nqH ja p a cT a B o a e H o ra

6HA>a (n o M oryhHOCTH a a r e )

3.1.1. H cTp aacH B a ibe H itje noTpeG H O a x o :

- n o c T o je O A a xm aB a jyh e o k o a h o c t h x o je y x a 3 y jy Ha t o a a HHje B jepoB aTH a n o ja B a t o k c h a h o c t h y b o a h , Ha n pH M jep a x o j e c y n c ra H q a H3pa3HTO

H ep acT B op H a y b o a h h a h j e M aaa B jep oB aT H oh a m e n o r n p o a a c x a x p o 3 6 H O A om xe M eM 6paH e h a h

- j e a o c T y n H a C T yan ja o a y r o T p a jH o j t o k c h a h o c t h y b o a h 3a G ecx H A M ea a x e h a h

- j e a o c T yn H O a o b o a >h o H H (j)op M aqH ja 3a pa3B pcTaBaH .e h 0 3 H a q a B a fte ca a c n e x T a a a tB o ra e cpeaH H e.

A x o je c y n c T a H q a c a a G o p a cT B op n a y b o a h , T p e 6 a pa3M O TpitTH M o ry h n o c T HCTpaACHBaaa a y r o T p a jH e t o k c h a h o c th y b o a h Ha D a p h n ia m a (o a je jB a x B, T a q x a 3.1.5.).3.1.2. HcTpa5KHBaH.e ro ije noTpeG H O a x o n o c T o je O A a xm aB a jyh e o k o a h o c t h x o je

y x a 3 y jy Ha t o aa HHje B je p o B a ra a n o ja B a t o k c h a h o c t h y b o a h , Ha n pH M jep a x o j e c y n c r a H q a H3pa3H To H ep acT B op H a y b o a h h a h j e M a a a B jep oB aT H oh a m e n o r n p o a a c x a x p o 3 G H o a o m x e MeM GpaHe.

3.2 Pa3rpaaA .H BO CT

3.2.1. E H O A om xa3.2.1.1. J la x a 6nopa3rpaaA>H BO CT 3.2.1.1. H cT p a> xH B a fte HHje n o T p e 6 H o cn p oB oaH T H a x o j e cy n cT aH q a

H eo p ra H cx a .

HanoMeHa:K o aoH a 1. obot oajeA>xa yTBpljyje craHaapaHe noaaTKe x o jq cy noTpeGHH 3a cyncTaHqe x o je cy npoH3BeaeHe hah yBe3eHe y KOAHHHHaMa oa HajMame 100 KHAorpaMa no npoii3Bot)aqy hah yB03HHKy Ha roan u ifteM HHBoy.C bh octbah Ghthh 4>H3HqK0-xeMHjcKH, tockhkoaohikh h eKOTOKCHKOAOuiKH noaauH Kojn cy aocTynHH Tpe6a aa 6yay aocTaBibeHH. 3a cyncTaHqe xoje He cnaaajy y cyncTaHqe Koje H3a3HBajy 3a6pHHyT0CT hah y cyncraHqe ca ancnep3iiBHOM hah AHcj)y3HOM ynoTpeGoM, Te 3a cyncTaHqe 3a Koje ce npeaBHÎja aa he BjepoBaTHO HcnymiTH ycaoBe 3a xaacHijiHKaqHjy Ha ocHOBy ecjjexaTa no 3apaBA>e hah jkhbothy cpeanHy y CKAaay ca qaaHOM 8. 3aKOHa o xeMHKaaiijaMa, noTpeÔHo je aocTaBHTH caMO 4>H3HqKO-xeMHjcKe noaaTKe.KoaoHa 2. obot oajeA>xa HaBoan noceGHa npaBHaa y CKAaay ca KojHM TpaareHH noaaqn Mory 6hth H3ocTaBA>eHH, 3aMHjeH,eHH apyrHM noaauHMa, aocraBJbeHH y apyro j (j)a3H hah npnaaroljeHH Ha apyrn Haqim. A ko cy ncnyfteHH ycaoBH y cxaaay ca koaohom 2. xojn ao3Boa.aBajy oacrynaiba, perncrpaHT he to jacHo HaBecTH h CBaKO oacTyname o6pa3ao>xHTH y oaroBapajyheM oajeA>xy aocnjea.

E - cyncraHqe npoH3BeaeHe hah yBe3eHe y K oa n q iiH a M a oa 10 TOHa hah Bume

2. TOKCHKOJIOUIKH nO/jAIjHKOJIOHA 1.

CTAHHAPHHH 3AXTJEBHKOJIOHA 2.

nOCEEHA nPABHJIA 3A OflCTYnAIEE OH KOJIOHE 1.2.1 HaapajKHBame xo>xe 2.1.1. HaapaacHBafte xo>xe in v ivo 2.1.1. Hcrpa>KHBaH>e HHje noTpeGHO axo:

- je cyncraHqa pa3BpcraHa xao narpH3ajyha h a h Haapaacyjyha 3a xo>xy h ah- je cyncTaHqa jaxa xnceAHHa (pH <2,0) h a h 6a3a (pH >11,5) h ah

- je cyncTaHqa 3anaa>HBa Ha Ba3ayxy Ha co6Hoj TeMnepaTypH h a ii- je cyncTaHqa pa3BpcraHa xao BpAO OTpoBHa y aoaupy c ko>kom h ah- k o a HCTpa>KHBatt>a axyTHe aepMaaHe t o k c h a h o c th HHje yTBpljeHO Haapa/xyjyhe ajeaoBame Ha xo>xy ao rpaHHAHe A03e (2.000 mg/kg TjeaecHe Te>KHHe).

rtoHeajeibaK, 21. AeqeMGap 2009. CJiyiKEEHH rJIACHHK PEnyEJIHKE CPIICKE__________ Epoj 113 - CTpaHa 17

2.2 HaapajKHBa&e oqnjy 2.2.1. Haapa>KHBaH.e oqnjy in v ivo 2.2.1. HcTpa>xHBaH>e HHje noTpeÔHo axo:

- je cyncTaHqa pa3BpcTaHa xao HaApancyjyha 3a ohh ca onacHouihy oa 036ha>hot ouiTehefta oqnjy hah

- je cyncTaHqa pa3BpCTaHa xao Harpioajytia 3a xon<y h noa ycaoBOM qa je perucTpaHT cyneraHqy pa3BpcTao xao HaApancyjyhy 3a ohh hah - je cyncTaHqa jaxa KHceAHHa (pH <2,0) hah 6a3a (pH >11,5) hah- je cyncTaHqa 3anan>HBa Ha Ba3AVxy Ha coGHoj TeMnepaTypH.

2.4 M yTareHocr2.4.2. IJ^HToreHeTCKO HCipa>KHBaii>e in vitro Ha heanjaMa cncapa hah in vitro MHKpoHyKAeyc TecT

2.4.2. Hcrpa*HBaH.e oôhhho HHje noTpeGHO axo:- cy AocrynHH OAroBapajyhH noAaqn Ha ocHOBy qHToreHeTcxor HcnHTHBa&a in v ivo HAH- je no3HaTO Aa ce paqn o xaHqeporeHoj cyncTaHqH 1. hah 2. xaTeropnje hah MyrareHoj cyncTaHqH 1, 2. hah 3. xaTeropnje.

2.4.3. In vitro HCTpancHBaHbe reHCKHX MyTaquja Ha hennjaMa cncapa, axo je pe3yATaT H3 oajeA>xa A, Taqxa 2.4.1. h oajeAjxa E, Taqxa 2.4.2. HeraTHBaH

2.4.3. HcTpa5KHBaK>e o Ghhho Hnje noTpeÔHo axo cy AOCTynHH OAroBapajyhH noqaqH H3 noy3AaHor in v ivo TecTa reHCKHX MyTaqnja na henHjaMa cncapa.

2.4 A x o je pe3yATaT 6hao xo jer reHOTOxcHxoAomxor HCTpaACHBaiba H3 OAjen>xa A hah E no3HTHBaH, TpeGa pa3MOTpHTH cnpoBoÇefte OAroBapajyhnx in v ivo HCTpa5KHBaH>a 3 a MyTareHOCT.

2.5 AxyTHa toxchhhoct

2.5.2. HHxaAaqHOHa npHMjeHa

2.5.3. HepMaAHa npHMjeHa

2.5 HcTpaaaiBarbe, oahocho HCTpaACHBaiba reHepaAHO HHcy noTpeGHa axo:- je cyncTaHqa pa3BpcTaHa xao HarpH3ajyîia 3a xo>xy.y cnyqajy cyncTaHqH xoje HHcy racoBH, noTpe6HO je noAaTxe H3 t. 2.5.2. h 2.5.3. npyjKHTH 3a HajMaae jou i jeqaH nyT npHMjeHe y3 noAaTxe 3a opanHH nyT (oAjeA>ax A, Taqxa 2.5.1.). H36op q p yro r nyTa 3aBHCHhe oa BpcTe cyncTaHqe h BjepoBaTHor nyTa H3naraH»a n>yAH. A x o nocTojn caMO jeqaH nyT H3Aaraaa, HH^opMaqnje TpeGa npyixHTH caMO 3a Taj nyT.2.5.2. HcnHTHBaite HHxaAaqnoHHM nyTeM npHMjeHe je noroAHO axo je BjepoBaTHO H3AaraH.e n>ynH yAHca&eM, y3HMajy&H y o63Hp HanoH nape cyncTaHqe h / hah MoryhHocT ranaratba aepocoAHMa, qecTiiqaMa hah xanA>HqaMa HHxanaGHAHe BenHqHHe.2.5.3. HcniiTHBaibe AepManHHM nyTeM npHMjeHe je noroAHO axo:- yAHca&e cyncTaHqe HHje BjepoBaTHO,- je BjepoBaTaH AOAHp c koacom toxom npoH3BOA&e h / hah ynoTpe6e h- 4>H3Hqxo-xeMHjcxe h ToxcHxoAomxe ocoGhhc yxa3yjy Ha MorytiHocT 3HaqajHe ancopnqHje xpo3 xoAcy.

2.6 Tokchahoct koa noHOBA>eHe npHMjeHe2.6.1. HcTpa)KHBaH.e xpaTXOTpajHe TOXCHqHOCTH XOA nOHOBJbeHenpHMjeHe (28 AaHa) Ha jeAHoj bpcth , Myjxjax h nœHxa, HajnpHMjepeHHjn nyT npHMjeHe y3HMajyhH y oÔ3Hp BjepoBaTHH nyT H3AaraH>a A>yAH.

2.6.1. HcTpa>KHBaH>e xpaTXOTpajHe tokchahocth (28 AaHa) Hiije noTpe6Ho axo:- je AOCTynHa noy3AaHa CTyAnja cynxpoHHqHe (90 AaHa) hah xpoHHHHe ToxcHqHocTH, noA ycAOBOM Aa je xopHuitieHa oAroBapajyha BpcTa, A03a, pacTBapaq h nyT npHMjeHe hah

- axo ce cyncTaHqa TpeHyrao pacnaAa h HeMa aoboa>ho nonaTaxa o npoH3BOAHMa pacnaAaita hah- ce Monce HCKA>yqHTH peAeBaHTHa H3AO>xeHOCT.OAroBapajy&H nyT npHMjeHe Gnpa ce npeMa CÆeAehHM xpHTepnjyMHMa: HcnHTHBaH,e acpm aah h m nyTeM npHMjeHe je noroAHO axo:(1) yAHcaae cyncTaHqH HHje BjepoBaTHO h

(2) je BjepoBaTaH aoahp c koacom toxom npoH3BOAH>e h / hah ynoTpeôe h

(3) 4)H3iiqxo-xeMHjcxe h ToxcHKOAomxe ocoÔHHe yxa3yjy Ha MoryhHocT 3HaqajHe ancopnqnje xpo3 xoAcy.HcniiTHBaibe HHxaAaqHOHHM nyTeM npHMjeHe noroAHO je axo je BjepoBaTHO H3AaraH,e jbyAH yAncaaeM, y3HMajyhH y o63np HanoH nape cyncTaHqe h / hah MoryhHocT H3AaraH>a aepocoAHMa, qecTHqaMa hah xanÆHqaMa HHxanaGHAHe BeAHqiiHe.PerucTpaHT TpeGa Aa npeAnoncn HcnHTHBaibe cynxpoHHHHe tokchahocth , 90 AaHa (onjeibaK B, Taqxa 2.6.2.) axo yqecTanocr h Tpajame H3naraH>a n>yAH yxa3yje Ha noTpeGy 3a AyroTpajHiijiiM ucTpanciiBaibeM h axo je Hcny&eH jenaH oa obhx ycAOBa:- Apyrn pacnoAOAcnBH nonaun yxa3yjy Ha to Aa 6h cyncTaHqa Morna HMaTH onacHy ocoGnHy xoja ce He MOAce o txp h th HCTpancHBaifeeM xpaTXOTpajHe TOXCHqHOCTH HAH- Ha OAroBapajyhn HaqHH AH3ajHHpaHHM ToxcHxoxHHeTHqxHM HCTpanaiBaibHMa yTBpî)eHO je axyMyAHpaH>e cyncTaHqe hah h>chhx MeTa6onnTa y onpeî)eHHM TXHBHMa hah opraHHMa xoje 6h Morno ocTaTH HeoTxpHBeHo xoa HCTpaACHBa&a xpaTXOTpajHe toxchhhocth , a motao 6h aobccth ao lutcthhx ec^exaTa HaxoHAynce H3AOAteHOCTH.PerHCTpaHT je Ay*aH upejuiOACHTH, a MHHHCTapcTBo MOAce 3axTHjeBaTH AOAaraa HcnHTHBaita y cxnaAy ca qnaHOM 13. 3axoHa o xeMHxanHjaMa y cjbeAetiHM CAyqajeBHMa:- axo toxom 28-AHeBiior hah 90-AHeBHor HCTpaACHBaiba Hiije yTBptjeH NOAEL, ochm axo je pa3nor 3a to HenocToja&e Hence.tbeHHX tokchhhhx e^exaTa hah- y cnyqajy cyncTaHqH xoje H3a3HBajy 3a6piiHyT0CT (Hnp. 036HJbHe / Ternxe nocA>eAHqe) hah

CTpaHa 18 - Epoj 113 CHY^KEEHIi rJ IA C H H K PEnyEJTO K E CPE1CKE noHezyejbaK, 21. #eueM6ap 2009.

- axo nocToje Ha3HaKe oqpet)eHor e<j)exTa, a pacnonoiKHBH noqaqn HHcy Aobojt>hh 3a TOKCHKOAOHiKy KapaKTepH3aqnjy h / h ah KapaKTepH3aqHjy proHxa. y t o m cnyqajy je Moacna h npuMjepeHHje cnpoBecra noceGHa TOKCHKonouiKa HCTpaACHBaaa 3a HcnuTHBaae thx eijbexaTa (Hnp. HMyHOTOKCHAHOCT, HeypOTOKCHAHOCT HTA-) HAH- aKO nyT H3AaraH>a k o a npBo6iiTHor HCTpa>XHBaH,a tokchahocth k oa nOHOBJbeHe npHMjeHe HHje 6ho npHMjepeH c o63HpoM Ha OAeKHBaHH nyT H3naraH>a a ,\ a h . a mije Moryhe yAHHHTH excrpanonaqHjy Ha Apyrn nyT hah

- axo nocToje noceGmi pa3A03H 3a 3a6pHHyT0CT y norneqy H3AO>KeHOCTH (Hnp. ynoTpe6oM y npoH3BOAHMa 3a uiHpoxy noT pom ay AOAa3H ao hhboa H3AO>KeHOCTH KojH npnGAHIKHO OATOBapajy A03aMa KOA Kojux ce MOACe oqeKHBaTH tokchaho AjenoBame Ha n>yqe) hah- axo to k o m 28-AHeBHor hah 90-AHeBHor HCTpaxcHBama HHcy OTxpuBeHii e(f>exTH Kojn cy ce noxa3aAH koa cyncTaHqe xoja noxa3yje jacHy Be3y y MOAexyAapHoj CTpyxTypn ca cyneraHqoM xoja ce HCTpaixyie.

2.7 PenpoAyxTHBHa tokchahoct 2.7.1. C k ph h h h t TecT penpoAyxTHBHe / pa3BOjHe TOKCHAHOCT Ha jeAHOj BpCTH, axo Ha ocHOBy pacnonoaciiBHX HH(})OpMaqHja 0 CTpyKTypHO CpOAHHM cyncTaHqaMa, npoqjeHe (Q )S A R h in vitro MeToqa HeMa AOKa3a qa je cyncTaHqa pa3BojHO tokchaha

2.7.1. O bo HCTpaacuBaae HHje noTpe6HO axo:- je no3HaTO Aa je cyncraHqa reHOToxcHAHH xaHqeporeH h axo cy cnpoBeqeHe OAroBapajyhe Mjepe ynpaBA.aaa p h 3h ko m h ah

- je no3HaTO Aa cyncTaHqa HMa MyTareHH ecjiexaT Ha noAHe henqje h axo cy cnpoBeqeHe oqroBapajyhe Mjepe ynpaBA>aaa p io h k o m hah

- ce Moace HCKAbyAHTH peneBaHTHa H3A0>xeH0CT Jb y m hah

- je pacnoAoacHBa CTyAHja npeHaTaAHe pa3BojHe tokchahocth (oqjenbax B, Tanxa 2.7.2.) h ah CTyqqja penpoAyxTHBHe tokchahocth xpo3 ABnje reHepaqnje (oajen>ax B, Taqxa 2.7.3.).A x o je no3HaTO Aa cyncraHqa HMa niTeTaH eijiexaT Ha nnoAHOCT. Te 3aAOBOA.aBa xpHTepujyMe npeMa xojHMa ce cyncTaHqe pa3BpcraBajy xao penpoAyxTHBHO TOKCHAHe 1. HAH 2. xaTeropuje (R epr Cat 1 hah 2: R60) 11 axo cy pacnoATOXHBH noqaqH aoboa>hh 3a noy3qaHy npoujeHy pii3HKa, HHje noTpe6Ho cnpoBOAHTH qoqaTHo HcnHTHBaite 3a iuioahoct. H nax. Tpeoa pa3MOTpHTH HCnHTHBafte 3a pa3B0jHy TOKCHAHOCT.A x o je no3HaTO qa cyncTaHqa H3a3HBa pa3BojHy tokchahoct, Te 3aAOBo."baBa xpHTepnjyMe npeMa xojHMa ce cyncraHqe pa3BpcraBajy xao penpoAyxTHBHO TOKCHAHe 1. HAH 2. xaTeropHje (Repr Cat 1 hah 2: R61) h axo cy pacnononcHBH noqaqn aoboa>hh 3a noy3AaHy npoqjeHy pioH xa, HHje noTpe6HO cn p oB oaH T H

AoqaTHO HcnHTHBaae 3 a pa3BojHy tokchahoct. H nax, Tpe6a pa3MOTpirrn HcnHTHBarbe ecjiexaTa Ha nAOAHOCT.A x o nocToje 036hjbhh pa3A03H 3a 3a6pHHyTOCT c o63HpoM Ha Moryfm ocr utTeTHHX eijiexaTa Ha nAOAHOCT h ah pa3Boj, peracTpaHT Moace vMjecro cxpuHHHr TecTa npeqnonaiTH HCTpa>KHBaH,e npeHaTaAHe pa3BojHe tokchahocth (oAjeJbax B, Taqxa 2.7.2.) h ah HcrpaaaiBa&e penpoAyxTHBHe tokchahocth xpo3 ABHje reHepaqHje (oAjen>ax B, Taqxa 2.7.3.).

2.8 ToKCHKOKHHeTHKa 2.8.1. IIpoqjeH a TOKCHKOKHHeTHAKor noHamama cyncTaHqe Koja ce Monce Ao Ghth Ha ocHOBy pacnonoixHBHx peAeBaHTHHX HHcJjopMaqHja

3. EKOTO KCH KO JIO UIKH n O flA IJ H

KOJIOHA 1. CTAHflAPflHH 3AXTJEBH

KOJIOHA 2.nOCEBHA nPABHJIA 3A OJICTynAH>E O/I KOJIOHE 1.

3.1.3. H cn H T H B a & e xpaTK O Tpa jH e t o k c h a h o c t h Ha p n 6 a M a , p e ra cT p a H T MOJKe pa3M OTpHTH MOTyllHOCT HcnHTHBam a q y r o T p a jH e t o k c h a h o c t h

yM jecT o xpaTK O Tpa jH e

3.1 .4 . H c m iT H B a & e p e c m ip a T o p H e

HHXHGnqHje axT H B H or Myn>a

3.1 .3. H c T p a a a rB a a e H iije n o T p e G n o a x o :

- n o c T o je O A a xm aB a jyh e o k o a h o c t h x o je y x a 3 y jy Ha t o A a H iije B je p oB a rn a n o ja B a t o k c h a h o t n jen o B a ib a y b o a h , Ha n pH M jep a x o j e c y n cT a H q a H 3 p a3 iiro H ep acT B op H a y b o a h h a h j e M ana B jep oB a T H oh a H>eHor n p o a a c x a x p o 3 G q o A o m x e M eM GpaHe h a h

- j e p a cn oA o ixH B a C T yq iija q y r o T p a jH e t o k c h a h o c t h y b o a h 3 a p n oe .A x o n p o q je H a 6e36jeAH O CTii x eM H xaA n je y c x n a q y ca qnaHOM 26. 3 a x o K a 0

xeM H xaA H jaM a y x a 3 y je Ha n o T p e 6 y 3a qoqaTH H M HCTpa>XHBaK.eM ed ie xa T a Ha B oqeH e op raH H 3M e, TpeG a pa3M O TpnTH M o ry h H o c T H cnuTH Baiba A y ro T p a jH e

t o k c h a h o c t h y b o a h , x a x o j e onu caH O y OAjeA>xy B. H 3 6 o p HcnHTHBam a 3 a s iic ii o a p e3 yn T a T a n p o q je H e 6e3 6 jeA H ocTH xeM H xaA n je .A x o j e c y n c ra H q a c n a 6 o p acT B op H a y b o a h , T p e 6 a pa3M 0TpnTH M o ry h K o c r

H cm iTH B a iba A y ro T p a jH e t o k c h a h o c t h Ha p n 6 a M a (o q je x b a x B o b o t n p in o r a . T a q x a 3 .1 .6 .).

3.1 .4. H c rp a a a iB a ib e H q je noTpeG H O cnpoBO AH TH a x o :

- HeM a eM u cu ja y n o c T p o je m e 3a n p eA H m h aB am e O TnaAH irx B oqa h a h

- n o c T o je O A a xm aB a jyh e o k o a h o c th x o je y x a 3 y jy Ha t o A a H n je BjepoBaTHa n o ja B a t o k c h a h o c t h 3a M n xp o6 H e op raH H 3M e, Ha n p H M jep a x o j e cy n cT aH q a H3pa3HTO H ep acT B op H a y b o a h h ah

- ce yTBpAH A a je c y n c ra H q a 6 H opa3rp aA JM iB a 11 a x o c e x o H q e H T p a q u je

x o p n m h e H e k o a H cnHTHBam a H ana3e yH y T a p n o q p y q ja x o H q e H T p a q u ja x o je ce M o ry oqexH B aT H y o m a A H H M B oqaM a x o je c e A O B oqe y n o c r p o je i t e 3a n peq iim h aB aH >e o rn a A H iix B oqa .

noHeqjejbax, 21. qeqeMßap 2009. CJIYTKEEHH rJIACHHK PEnyEJIHK E CPÜCKE Epoj 113 - CTpaHa 19

O bo HCTpancHBaH>e ce Monce 3aMHjeHHTH TecTOM HHXn6nqHje HHTpH(j)HKaqqje axo pacnoAoacHBH noAaqn yxa3yjy Ha to qa cyncTaHqa Monce 6hth hhxhôhtop pacTa hah tjiyHKHnje mhkpo6hhx opraHH3aMa, a noceÔHo H H TpH cjw K yjy fm x Garreprija.

3.2 Pa3rpaAJBHBOCT

3.2.2. AGnoTCKa3.2.2.1. XHApoAH3a Kao (jjyHKqqja pH

3.2 HoqaTHO ncnHTHBaibe pa3rpaqn>HBOCTH Tpe6a pa3MOTpHTH aKO npoqjeHa 6e36jeqHOCTH xeMHKanqje y CKAaqy ca AnaHOM 26. 3axoHa o xeMHKaAnjaMa yKa3yje Ha noTpe6y qa ce qoqaTHo HcrpaiKH pa3rpaqA>HBOCT cyncTaHqe. H36op HcnHTHBaaa 3aBHCH oq pe3yATaTa npoqjeHe 6e36jeqHOCTH xeMHKanqje.

3.2.2.1. HcTpaACHBafte HHje noTpeGHO aKo:- je cyncTaHqa 6Hopa3rpaqn>HBa hah

- je cyncTaHqa H3pa3HTo HepacTBopHa y b o a h .3.3 CyqÖHHa h noHauia&e y acHBOTHojcpeAHHH3.3.1. C k ph h h h t TecT Ha ancopnqHjy / qecopnqqjy

3.3.1. HcTpaAOTBarbe Hnje noTpeÔHO cnpoBoqHTii aKo:- ce Ha ocHOBy 4»i3HAKO-xeMqjcKHX oco6HHa cyncTaHqe Moace oqeKHBaTH qa cyncraHqa HMa HH3AK noTeHqHjaq ancopnqqje (Hnp. cyncraHqa HMa HH3aK KoetjiHUHjeHT pacnoqjene OKTaHOA / Boqa) h ah

- ce cyncraHqa h H>eHH raaBHH npoH3Boqn pa3rpaqH»e 6p30 pacnaqajy.HanoMeHa:KonoHa 1. o b o t ofljeAjxa yTBpljyje CTaqqapqHe noqaTKe noTpeÔHe 3a cBe cyncTaHqe nporoBeqeHe hah yBe3eHe y KOAHAHHaMa o a 10 TOHa hah BHLue y cxnaqy ca AnaHOM 5. o b o t npaBHAHHKa. n oqaqn 3axTHjeBaHii y koaoh h 1. o b o t oqjeibKa cy qoqaTaK noqaqnMa 3axTHjeBaHHM y koaoh h 1. oqjen>Ka A o b o t npHAora.

B - cyncTaHqe n p o H 3BeAeHe h a h yB e3eH e y KOAHAHHaMa oa 100 TOHa h a h BHuie

1. n O / IA I IH O O H 3 M H K O -X E M H J C K H M O C O E H H A M A C y n C T A H I I E

KOJIOHA 1. CTAHflAPHHH 3AXTJEBH

KOJIOHA 2.nOCEEHA nPABHJIA 3A OUCTynAIBE O/l KOJIOHE 1.

1.15 O raßH AH ocr y opraHCKHM pacTBapaAHMa h h a c h th t c t rqaBHHx npoH3Boqa pa3rpaqH>e (noTpeÔ H o je caMO a x o ce CMaTpa qa je CTaÖHAHOCT cyncTaHqe KpHTHAHa)

1.15 McTpa>KHBaH>e HHje noTpeÔHo k o a HeopraHCKHX cyncraHHH.

1.16 KoHCTaHTa AHCoqnjaqHje 1.16 McTpaACHBame HHje noTpeSH o cnpoBoqiiTH axo:- je cyncTaHqa x h a p o a h t h a k h HecTaÔHAHa (BpujeMe noqypacn aqa n cn oq 12 qacoB a) h a h qaK o oKCHqyje y b o a h h a h

- HcnHTHBaae HHje M oryhe cnponecrH H3 HayAHHX pa3nora, Ha npHMjep aKo aHaAHTHAKa MeToqa HHje ao bo jb ho ocjeTÆHBa.

1.17 BHCK03HOCT

2. TOKCHKOJIOUIKH nOJIAHHKOJIOHA 1.

CTAH/IAPHHH 3AXTJEBHKOJIOHA 2.

nOCEEHA nPABHJIA 3A O flCTYnABE OH KOJIOHE 1.2.4 A x o je pe3yATaT 6h ao K o jer reH O ToxcH xoAou ixor HcrpaiKHBaita in v itro H3 oqjeA>axa A hah E no3HTHBaH, a pe3yATaTH in v iv o Hcrpa>xHBaH»a HHcy pacnonoiKHBH, perHCTpaHT he npeqqoiKHTH oq roB ap a jyh e in v iv o HcrpaacHBaite TeHOTOKCHAHOCTH Ha C0M3TCKHM heAHjaMa.A ko Beh n o c ro jn no3HTHBaH pe3yATaT in v iv o HcrpaiKHBatba Ha coMaTCKHM hennjaMa, TpeGa ncnHTaTH noTeH qqjaq M yTareHor etjteKTa Ha noAHe henqje Ha ocHOBy qocTynH nx noqaTaxa , yxn>yAyjyhH TOKCHKOKHHeTHAxe noqaTKe. A ko ce He M ory H3Bec™ jacHH 3aKA.yqqH o MyrareHOM eijieKTy Ha noAHe henqje, TpeGa pa3MOTpiiTH M oryhHocT qoqaTHHx HcnHTHBaaa.

2.6 T o k c h ah o c t k o a noHOBn>eHe npHMjeHe2.6.1. H cTpa*H BaH ,e xpaTKOTpajHe TOKCHAHOCTH KOA nOHOBJbeHe npHMjeHe (28 qaH a) Ha jeqH o j bpcth , MyqcjaK h >xeHxa, HajnpiiMjepeHHjH nyT npHMjeHe y3HMajyi\H y oÔ3Hp sjepoBaTHH nyT H3naraH>a A.yqH, ochm a x o cy Te HHcjiopMaqqje Beh qocTaBÆeHe y oKBHpy 3axTjeBa H3 oqjensxa E hah a x o ce npeqnaacy HcnHTHBama y cxnany c TanxoM 2.6.2. OBor oq jeA ixa2.6.2. H crpaacHBafte cynxpoHHAHe t o k c h a h o c t h (90 qaH a) Ha jeqH oj BpcTH, ra o q a p n , Myacjax h HceHxa, HajnpHMjepeHHjq nyT npHMjeHe y3HMajyhn y o63Hp BjepoBaTHH nyT H3qaraH)a A>yqH

2.6.2. HcTpaiKHBafte cynxpoHHAHe t o k c h a h o c t h (90 qaH a) Hiije noTpe6H o aKo:- je q ocryn H a noy3qaHa CTyqqja xpaTKOTpajHe to k c h a h o c th (28 qaH a) xo ja noxa3yje tok ch a h c e<j)eKTe c tcu ikhm nocn>eqHqaMa y cxnaqy c KpHTepnjyMHMa npeMa KojuMa ce cyncTaHqe pa3BpcTaBajy Kao R48, rq je je npuMjeHOM oq roB ap a jyh er ijraxTopa HecnrypHocTH yTBpljeHH NOAEL - 28 qaHa M oryhe eKCTpanonnpaTH y NOAEL - 90 qaHa 3a h c th nyT H3naraH>a hah- je qocryn H a noy3qaHa cryn q ja xpoHHAHe t o k c h a h o c t h , n o q ycnoBOM qa je y rboj KopnuiheHa oq roB ap a jyh a Bpcra h nyT npHMjeHe h ah

- ce cyncTaHqa TpeHyTHO pacnaqa h HeMa a o b o a ,ho noqaTaKa o npoH3BoqHMa

CTpaHa 20 - Bpoj 113 CJIYTKEEHH rJIA C H H K PEnY BJIH K E CPHCKE rioHeqjejbaK, 21. qeqeMÔap 2009.

-

pacnaqaaa (KaKO 3a CHCTeMCKe etjjeKTe TaKO h 3a etjjeKTe na MjecTy yHOca) turn- je cyncTaHua HepeaKTHBHa, HepacTBopHa h He Moace ce yqaxHyra Te HeMa aoKa3a o ancopnqqjH h aKO 28-qHeBHHM „rpaHHHHHM tcctom“ Huje yTBpîjeHa tokchhhoct, noceÔHO aKO je OBaj nyT noBe3aH c orpaHHHeHOM MoryhHomhy H3aaraH.a Jbyqn.OaroBapajyhn nyT npHMjeHe 6npa ce npeMa cjbeqeliHM KpnTepnjyMHMa: HcnHTHBaae qepManHHM nyTeM npHMjeHe noTpeÖHO je aKo:(1 ) je BjepoBaTaH qoqup c kohcom tokom npoH3BoqH>e n / hjih ynoTpeOe h(2 ) tjjH3HHKO-xeMHjcKe ocoöim e yKa3yjy Ha MorytiHocT 3HanajHe ancopnquje Kpo3 Koaty H(3 ) Hcny&eH je jeqaH oq obhx ycnoBa:- Koq HcnHTHBafta aKyTHe qepMaqHe tokchhhocth yTBpljeHO je tokchhho fljejioBa&e y MaitHM qo3aMa Hero Koq HcnHTHBaita opajiHe tokchhhocth hjih- Koq HCTpaatHBaaa HaqpaJKHBa&a Koate h / hjih onnjy onaaceHH cy chctcmckh etjjeKTH hjih qpyrn 3HaKOBH ancopnqHje hjih

- HcnHTHBaaa in vitro noKa3yjy 3HanajHy ancopnqnjy Kpo3 Koacy hjih

- Koq cTpyKTypHO noBe3aHiix cyncTaHiiH noTBptjeHa je 3HanajHa qepMaqna tokchhhoct hjih npoqnpaibe Kpo3 Koacy.HcnHTHBaae HHxajiaqHOHHM nyTeM npHMjeHe noTpeÖHO je aKo:- je BjepoBaTHO H3Jiaraite Jtyqn yqqcaiteM , y3HMajyhn y oÖ3Hp HanoH nape cyncTaHne n / hjih MoryhHocr H3Jiaraita aepocojiHMa, necTiiqaMa hjih KamtHqaMa HHxajia6HjiHe BejiHHHHe.PerncTpaHT je qyacaH npejqioatHTH, a MHHHCTapcTBO Moate 3axTiijeBaTii qoqaraa HCTpaacHBaaa y CKJiaqy ca HJiaHOM 13. 3aKOHa o xeMHKannjaMa y CJBenehHM cnynajeBHMa:- aKo tokom 90-ÄHeBHor HCTpaaiHBaaa Huje yTBpljeH N O A E L , ochm aKO je pa3Jior 3a t o Henoeroja&e HeacejteHnx tokchhhhx etjjeKaTa hjih- y cnynajy noceÔHO 3a6pHH>aBajyñe tokchhhocth (Hnp. 036HibHe / TeuiKe nocjBeflHqe) hjih- aKo nocToje Ha3HaKe oqpetjeHor etjjeKTa, a pacnonoacuBH noqaqii h h c v

flOBoibHH 3a TOKCHKOJiouiKy KapaKTepH3aqnjy h / hjih KapaKTepmaqniy piniiKa. Y tom cnynajy je MO*qa h npHMjepeHiije cnpoBecTii noceÔHa TOKciiKonoiiiKa HCTpaacHBaita 3a HcnuTHBaae th x etjjeKaTa (Hnp. HMyHOTOKCHHHocr. HeypOTOKCHHHOCT HTfl.) HJIH- aKO nocToje noceÔHH pa3Jio3H 3a 3a6pHHyT0CT y noraeqy H3JioaceHOcrn (imp. ynoTpeOoM y npoH3BoqiiMa niHpoKe noTpom ae qoqa3ii qo HHBoa i g -Io j k s h o c th

KojH npHÖJiHatHO oqroBapajy qo3aMa Koq Kojux ce Moace oneKHBant t o k c h h h o qjejioBaibe Ha Jtyqe).

2.7 PenpoqyKTHBHa tokchhhoct 2.7 HcTpaaaiBaibe HHje noTpeÖHO aKo:- je no3HaTO qa je cyncTaHqa reHOTOKCHHHH KaHqeporeH h cnpoBeqese c y oqroBapajyhe Mjepe ynpaBjbaaa ph3hkom h j i h

- je no3HaTO qa cyncraHqa iiMa MyTareHH etjjeKaT Ha noqHe he.nuje h c n p o 3eqeH e cy oqroBapajyhe Mjepe ynpaBjbaaa ph3hkom hjih- cyncTaHqa HMa cqaôy TOKCiiKoqouiKy aKTHBHOCT (Ha ocHOBy pacno.iexnBHx HcnHTHBaaa HeMa qoKa3a o tokchhhocth ), Ha ocHOBy tokch ko khhc i u -. • x noqaTaKa Moace ce qoKa3a™ qa oqroBapajyhHM nyTeBHMa im a ra a a :-:e qoqa3H qo CHCTeMCKe ancopnquje (Hnp. KOHqeHTpaqnje y nqa3MH / KpBii c y npHMjeaoM ocjeTÆHBe MeToqe Hcnoq rpaHnqe qeTeKquje h cyncTaHqa h aenn M eiaô :~ ;m i Huey npucyTHH y ypHHy, x y m h H3qaxHyTOM Ba3qyxy), a H3qoHceHtxrnî jv . jlh HeMa hjih OHa mije 3HanajHa.A k o je no3HaTO qa cyncTaHqa HMa uiTeTaH etjjeKaT Ha nqoqHocrr tc 3a~cao.-baBa KpHTepnjyMe npeMa KojnMa ce cyncTaHqe pa3BpcTaBajy Kao penpojvj-rrns:-: : TOKCHHHe 1. Him 7. KaTeropnje (Repr Cat 1 hjih 2: R60) h aKO cy pacno;i : : « i 3 H noqaqH qoBOÆHH 3a noy3qaHy nponjeHy pH3HKa, Hiije noTpeÔHO cnposom m i qoqarao ncnHTHBaae 3a nqoqHocT. HnaK, noTpeÔHo je pa3MOTpiiTH HcnHTHBaae 3a pa3BojHy tokchhhoct.A k o je no3HaTO qa cyncTaHqa H333HBa pa3BojHy tokchhhoct Te 3aqoBo.q>aBa KpHTepujyMe npeMa KojiiMa ce cyncTaHqe pa3BpcTaBajy Kao penpoqyxmB:-:;? TOKCHHHe 1. Iran 2. KaTeropHje (Repr Cat 1 unii 2: R61) h aKO cy pacno.cctsjran noqaqn qoBoibHH 3 a noy3qaHy npoqjeHy pii3HKa, Hqje noTpe6no cnpoBoznra qoqarao HcnHTHBaite 3a pa3BojHy tokchhhoct. HnaK, noTpeÖHO je paa.'-tjTTJiTH HcniiTHBaite etjjeKaTa Ha nnoqHOCT.

2.7.2. McTpaacHBa&e npeHaTajiHepa3BOjHe TOKCHHHOCTH Ha jeflHOj BpcTH, HajnpHMjepeHHjn nyT npHMjeHe ya n M a jyh n y o63Hp BjepoBaran nyT H3JiaraH.a jiyq n

2.7.2. PIcTpajKHBaiie ce npBo cnpoBoqH Ha jeqHoj bpcth. OqjiyKa 0 tom j xcne qn ce HCTpajKHBaH>e na qpyro j bpcth cnpoBecTH Ha Himoy OBe k o h h h iih c k î rpyne h j i h koq cjbeqeher kobhhuhckot npara TpeSa qa ce 3acHHBa h e pe3yqTaTHMa npBor iicniiTiiBaita h cbhm ocTajiHM peqeBaHTHHM noqaniM a :-:ojii cy pacnoqojKHBH.

2.7.3. HcTpajKHBa&e penpoqyKTiiBHe TOKCHHHOCTH Kpo3 qBHje reHepanqje, jeqHa BpcTa, MyiKjaK h aceHKa, Hajnpn- MjepeHnjn nyT npHMjeHe y3HMajyhn y OÔ3HP BjepoBaTHH nyT H3JiaraH>a Jbyqn, aKO je 28-qHeBHo nan 90-qHeBHo HCTpaacHBafte noKa3aao uiTeTHe etjjeKTe Ha penpoqyKTHBHe opraHe h j i h

TKHB3

2 .7 .3 . HcTpajKHBaite ce npBo cnpoBoqn Ha jeqHoj bpcth. OqqyKa 0 t o m s x c h e qn ce HCTpajKiiBaibe Ha qpyro j bpcth cnpoBecm Ha Himoy OBe KonnitHiiHCKe rpyne h j i h Koq citeqeher KoquniiHCKor npara Tpeôa qa ce 3acHHBa na pe3yqTaTHMa npBor HcnHTHBaaa 11 cbhm ocTajiHM peqeBaHTHHM noqamn-ia kojh cy pacnoqojKHBH.

rioHeqjejbaK, 21. qeqeM6ap 2009. C Jiy/K EEH H EJIACHHK P E nyE JIH K E CPÜCKE Epoj 113 - CrpaHa 21

3. EKOTOKCHKOJIOHIKH II O/l A UM

K O J IO H A 1.CTAH /1 AP/1HH 3 A X TJE B H

K O J IO H A 2.n O C E E H A n P A B H J IA 3 A O / lC T y n A fB E O/l K O JIO H E 1.

3.1 T okchhhoct y BoqH

3.1.5. Hcm m tBa&e qyroTpajHeTOKCHHHOCTH Ha 6eCKHHMeH>aUHMa (npetjjepnpaHa BpcTa Daphnia); (aKO noqauH HHcy qoeraBibeHH y OKBupy 3axTjeBa H3 oqjejtKa A )3.1.6. McnuTHBafte qyroTpajHe tokchhhocth 3a pn6e (aKO noqaqn HHcy qocTaBjbeHH y OKBupy 3axTjeBa H3 oqjejBKa E)Oße HHtfjopMaquje ce npyatajy 3 a TanKe 3.1.6.1., 3.1.6.2. nun 3.1.6.3.3.1.6.2. HcnHTHBaae tokchhhocth Ha pnOaMa y paHOM jkhbothom CTaqujyMy (FELS)3.1.6.2. HcnHTHBafte KpaTKOTpajHe tokchhhocth Ha pnöaMa y craqujyMy eMÖpnja h CTaqqjyMy ca acyMaHHaHOM KecoM3.1.6.3. Pn6e, TecT pacra HajyBeHHHHHM pnöaMa

3.1 PerncTpaHT he npeqnojKHTH HcnHTHBaite qyroTpajHe tokchhhocth axo npoujeHa 6e36jeqH0CTH xeMHKaquje y CKqaqy ca nqaHOM 26. 3aK0Ha 0 xeMHKaqujaMa yi<a3yje Ha noTpe6y 3a qoqaTHHM HCTpa>KHBaH>eM etjjeKaTa Ha BoqeHe opraHH3Me. H36op ncnnTHBaaa 3aBncn oq pe3yqTaTa npoqjeHe 6e36jeqHocTH xeMHKanHje.

\

3.2 Pa3rpaqjbHB0CT

3.2.1. EHoaouiKa3.2.1.2. CiiMyqaqnoHO HcnHTHBa&e noTnyHe pa3rpaqq>HB0CTH y nOBpUIHHCKO) BOflH

3.2 PerncTpaHT he npeqnojKHTH qoqaTHO HcnHTHBa&e SnoqouiKe pa3rpaqq>HB0CTH aKO npoujeHa 6e36jeqH0CTH xeMHKaqqje y CKqaqy ca nqaHOM 26. 3aKOHa 0 xeMHKaqqjaMa yKa3yje Ha noTpeOy 3a qoqaTHHM HCTpa*HBaH»eM pa3rpaqjBHBocTH cyncTaHqe h h.chhx npoH3Boqa pa3rpaqe>e. H36op HcnHTHBaH»a 3aBHcn oq pe3yqTaTa npoujeHe 6e36jeqHocTH xeMHKaqqje h M 0*e yKq>yHHB3TH CHMynaqHOHO HcnHTHBaHbe y oqroBapajyhoj cpeqHHH (Hnp. Boqa, ceqHMeHT hbh 3eMJbHuiTe).

3.2.1.2. HcTpaJKHBaite HHje noTpeSHO aKo:- je cyncTaHqa H3pa3HTo HepacTBopHa y Boqn ran- je cyncTaHqa 6Hopa3rpaqjMBa.

3.2.1.3. CHMyqauHOHo ncnHTHBaae pa3rpaqH>e y 3eMjbHurry ( 3 a cyncraHue Koje HMajy bhcok noTeHqqjaq ancopnunje Ha 3eMn>HiiiTe)

3.2.1.3. HcTpajKHBaBbe HHje noTpeGHO ano:- je cyncTaHqa onopaai paqjLHBa hjih

- HHje BjepoBaraa qnpeKTHa h HHqupeKTHa ronoaceHocT 3eMJbHiiiTa.

3.2.1.4. CuMyqaqHOHO HcnHTHBa&e pa3rpaqite y ceqHMeHTy (3 a cyneraHqe Koje HMajy bhcok noTeHqqjaq ancopnqHje Ha ceqHMeHT)3.2.3. FIoqaqH 0 npoH3BoqHMa pa3rpaqq>e

3.2.1.4. HcTpajKHBafte HHje noTpeGHO axo:- je cyncTaHqa 6nopa3rpaqjbHBa iuih

- Huje BjepoBaTHa qnpeKTHa h HHqnpeKTHa H3qo>KeHOCT ceqHMeHTa.

3.2.3. Ochm aKo je cyncTaHqa 6Hopa3rpaqq>HBa.

3.3 CyqöiiHa u noHamaite y acHBOTHoj cpeqHHH3.3.2. EHoaKyMynaqHja y BoqeHHM BpcTaMa, no MoryhHOCTH pn6aMa

3.3.2. HcTpajKHBaae HHje noTpe6HO ano:- cyncTaHqa HMa HraaK 6H0aKyMyqaqH0HH noTeHqujaq (Hnp. log K ow <3) h / Han HH3aK noTeHqHjaq nponacKa Kpo3 GnonontKe MeMGpaHe ivm- HHje BjepoBaraa qnpeKTHa h HHqupeKTHa H3qo»ceHOCT BoqeHor cerMeHTa.

3.3.3. HoqaTHe HHtjjopMaqqje 0 ancopnqqjH / qecopnqqjH 3aBHCH0 oq pe3yqTaTa HcnHTHBaita Koje ce 3axTHjeBa y oqjejtKy E

3.3.3. HcTpajKHBaH>e HHje noTpe6Ho cnpoBoqHTH aKo:- ce Ha ocHOBy tjjH3HHKO-xeMqjcKHX oco6nHa cyncTaHqe Moace oneKHBa™ HH33K ancopnqnoHH noTeHqHjaq cyncTaHqe (Hnp. cyncraaqa HMa Hroax KoetjjHqujeHT pacnoqjeqe n-OKTaHoq / Boqa) huh

- ce cyncTaHqa 11 H.eHH npoiOBoqn pa3rpaqn.e 6p30 pacnaqajy.3.4 EtJjeKTH Ha KonHeHe opraHH3Me 3.4 OBa HCTpajKHBafta HHje noTpeGHO cnpoBoqHTH aKo qnpeKTHa h

HHqnpeKTHa H3qo>KeHOCT cemeHTa 3eMJbHuiTa Hiije BjepoBaTHa.A k o noqaqn 0 tokchhhocth 3 a KonHeHe opraHH3Me HHcy pacnoqojKHBH, onacHOCT 3 a KonHeHe opraHH3Me mojkc ce oqujeHHTH MeToqoM paBHOTeacHe pacnoqjeqe. H36op HcnHTHBan.a 3aBHCH oq pe3yqTaTa npoqjeHe 6e36jeqH0CTH xeMHKaqqje.PerncTpaHT he noce6HO y cnynajy cyncTaHqe c bhcokhm noTeHqqjaqoM ancopnqHje Ha 3eMJi>HuiTe h Bpqo nep3HCTeHTHiix cyncTaHqn pa3MOTpHTH MoryhHOCT HcniiTHBaH>a qyroTpajHe tokchhhocth yMjecTO KpaTKOTpajHe.

3.4.1. KpaTKOTpajHa tokchhhoct 3 a 6ecKHHMeH,aKe3.4.2. EcjjeKTH Ha MHKpoopraHH3Me H3 3eMq.HniTa3.4.3. KpaTKOTpajHa tokchhhoct 3 a Ghjbkc

CTpaHa 22 - Epoj 113 CJiyjKEEHH TJ1ACHHK PEIiyEJlHKE CPI1CKE IIoHeqjejbaK, 21. qene.MÔap 2009.

HanoMeHa:PerncTpaHT Ha HHBoy OBor oqjeq>Ka Mopa noqHqjeTH npqjeqnor h BpeMeHCKH pacnopeq 3a ncnyitaBarbe 3a.\TjeBa 113 oBor oqjejbKa y cnqaqy ca uiaHOM 5. craB 1. Tanna b).KonoHa 1. obo t oqjeibKa yTBptjyje craHqapqHe noqaTKe noTpeÔHe 3a CBe cyneraHqe npoH3BeqeHe h.th yBe3eHe y Ko.uiHitHaMa oq 100 TOHa w m BHuie y cnqaqy ca nqaHOM 5. ob o t npaBHqHHKa. IIoqaqH 3axTnjeBaHH y kojiohm 1. ob o t oqje.BKa cy qoqaTaK noqaqriMa 3axTHjeBaHHM y KoqoHH 1. oqjeq>aKa A h E.

T - cyneraHqe npoH3BeqeHe m u yBe3eHe y KoqHHHHaMa oq 1.000 TOHa m u BHme

2. TO KCH KO JIO IUKH ÜO/IAUH

KOJIOHA 1.CTAH/IAP/IHH 3AXTJEBH

KOJIOHA 2.nOCEEHA nPABHJIA 3A OUCTYriAIBE Ofl KOJIOHE 1.

2.4 A k o je pe3yjiTaT 6nno nojer in vitro reHOTOKCHKoqouiKor iicTpaaniBaH>a 113 oqjejbaKa A huh E no3HTHBaH, Moacqa he 6hth noTpeÔHO cnpoBecru q p y ro in v ivo HcnHTHBafte Ha combtckhm heqqjaMa, 3aBHCHO oq KBaqitTeia u pejieBaHTHOcTH cbhx pacnonoacHBHx noqaTana.A k o Beh noerojn no3HTHBaH pe3yqTaT in v ivo HCTpaaaiBaaa Ha cometckhm heqqjaMa, Tpeôa HcnHTaTH noTeHqqjaq MyTareHor etjjeKTa Ha n o .in e n eq itje Ha ocHOBy cbhx pacnoqoacHBHx noqaTana, yKjbynyjyliH TOKCHKOKHHeTiiHKe noqaTKe. A k o ce He Mory H3BecTH jacHH 3aKq>ynttH 0 MyTareHOM etjjeKTV Ha nonHe fteqHje, Tpeôa ph3motphth MoryhHocr qoqaranx HcnHTitBaaa.2.6.3. PerncTpaHT Moxce npeqqoxcnTH, a MHHHcrapcTBO Moace 3axTiijeBaTii HCTpaxcHBaHje qyroTpajHe tokchhhocth Koq noHOBÆeHe npHMjeHe ( >12 Mjeceqn) y cnqaqy ca nqaHOM 13. 3aKOHa 0 xeMHKaqqjaMa axo yH eeraqoer 11 Tpajaae H3qaraH>a q>yqH yKa3yje Ha noTpeôy 3a qyroTpajHqjHM jterpa;KHBaH,eM h HcnyfteH je jeqaH oq cjbeqehnx ycqoBa:- tokom 28-qHeBHor u n u 90-qHeBHor HCTpaxcHBatba onaxceHH cy noceÔHO 3a6pHH>aBajytiH tokchhhh ecjjeKTH c 036hjbhhm m u TeumiM nocjbeqimassa, a pacnoqoJKHBH noqaqn Hticy qoBoq>Hii 3a TOKCHKoqouiKy oqjeHy ilth KapaKTepH3aqHjy pH3HKa m u

- tokom 28-qHeBHor m u 90-qHeBHor HerpaqcHBaiba HHcy OTKpiiBeHii etjjen™ onaaceHH Koq cyneraHqe Koja noKa3yje jacHy cpoqHocT y MoneKyqcKoj CTpyKTypH ca cyncTaHqoM Koja ce HCTpaxcyje nqn- cyncTaHqa Moxtqa HMa onacHy ocoÔHHy Koja ce He Moxce otkph th 90-qHeBHHM HCTpajKHBaaeM.2.6.4. PerncTpaHT je q y *aH npeqqoJKHTH, a MiiHHCTapcTBO Moace 3axT iijeB aTH

qoqaTHa HCTpaqaiBaita y cnqaqy ca nqaHOM 13. 3aKona 0 xeMHKaqujaMa y cq.eqehHM cqynajeBHMa:- y cqynajy noceÔHO 3aôpHH>aBajyhe tokchhhocth (Hnp. 030iiq>He / Temne nocjbeqqqe) Hqn- ano nocToje Ha3HaKe oqpeljeHor etjjeKTa, a pacnoqo>KHBn noqann h h c v

qoBoqbHH 3 a TOKCHKoqouiKy oqjeHy h / m u KapaKTepH3aqqjy pH3HKa. y tom cqynajy je Moxcqa h npHMjepeHqje cnpoBecTH noceÔHa TOKCHKoqomna HCTpa>KHBaH>a 3a HcnHTHBa&e th x etjjeKaTa (Hnp. hmyhotokchhhoct. HeypOTOKCHnHOCT HTq.) H JIH

- ano nocToje noceÔHH pa3no3H 3 a 3a6piiHyTocT y norqeqy H3qo>KeHOCTH (Hnp. ynoTpeôoM y noTpouianKHM npoH3BoqnMa qoqa3H qo hhboe usqoJKeHoen: Kojit npHÔqH>KHO oqroBapajy qo3aMa Koq Kojux je onaxceHa tokchhhoct).

2.7 PenpoqyKTHBHa tokchhhoct 2.7 McTpa>KHBaH,e Hqje noTpeÔHO cnpoBoqHTH ano:- je no3HaTO qa je cyncTaHqa reHOTOKCHHHH KaHqeporeH h cnpoBeqeHe cy oqroBapajyhe Mjepe ynpaBq>a&a pH3HK0M m u

- je no3HaTO qa cyncTaHqa HMa MyTareHH etjjeKaT Ha noqHe heqqje h c n p c s e q e H e

cy oqroBapajyhe Mjepe y n p a B q ja fta pH3HKOM itrtH- cyncTaHqa HMa cqaôy TOKCHKoqouiKy aKTHBHOCT (Ha ocHOBy pacnoqoxciiBiix HcnHTHBaaa HeMa qoKa3a 0 tokchhhocth ), Ha ocHOBy TOKCHKOKHHeTHHKi:x noqaTana Moqce ce qoKa3aTH qa oqroBapajyhHM nyTeBHMa H3qaran.a He q on a a n

qo cHcreMCKe ancopnqHje (Hnp. KOHqeHTpaqqje y nqa3MH / KpBH cy npnMienoM ocjeTq>HBe MeToqe ncnoq rpaHHqe qeTeKqqje h cyncTaHqa h H»eHH M eraoo.um i HHcy npHcyTHH y ypuHy, jKyHH h H3qaxHyTOM Ba3qyxy), a H3qo*eHoera .‘byqn HeMa Hqn OHa HHje 3HanajHa.A k o je no3HaTo qa cyncTaHqa HMa uiTeTaH etjjenaT Ha nqoqHOCT Te 3aqoBO."ba3a KpHTepujyMe npeMa nojHMa ce cyncTaHqe pa3BpcTaBajy Kao penpoqyKTHBHo TOKCHHHe 1. u h u 2 . KaTeropqje (Repr C a t 1 m u 2 : R60) h ano cy pacno.iojKHSH noqauH qoBOÆHH 3a noy3qaHy npoqjeHy pH3HKa, HHje noTpeÔHO cnpoBoqim i qoqaTHo HcnHTHBafte 3a nqoqHOCT. HnaK, noTpeÔHO je pa3MOTpHTH HcnHTHBaH>e 3a pa3BojHy tokchhhoct.A k o je no3HaTO qa cyncraHqa H333HBa pa3BojHy tokchhhoct Te 3aqoBO.i>aBa KpHTepqjyMe npeMa KojHMa ce cyneraHqe pa3BpcraBajy Kao penpoqyKTiiBHO TOKCHHHe 1. Hqn 2 . KaTeropnje (Repr C a t 1 Hqn 2 : R61) h ano cy pacnoqo>KHBH noqaqH qoBOjtHH 3a noy3qaHy npoqjeHy pH3HKa, Hnje noTpeÔHO cnpoBoqiixn qoqaTHo ncnuTHBaite 3a pa3BojHy tokchhhoct. HnaK, noTpeÔHO je pa3.MOTpimi HcnHTHBaH>e etjjeKaTa Ha nqoqHOCT.

rioHeqjejbaK, 21. qeqeMÔap 2009. CJIV/KEEHM rJ IACHMK PEnYEJIHKE CPnCKE__________Epoj 113-CTpaHa 23

2.7.2. HcTpaKHBaHbe pa3BojHe t o k c h h h o c t h Ha jeqHoj BpcTH, HajnpHMjepeHHjn nyT npHMjeHe y3HMajytui y oÔ3Hp BjepoBaTHH nyT H3qaraaa ityqH2.7.3. HcrpajKHBarbe penpoqyKTHBHe t o k c h h h o c t h Kpo3 qBnje reHepaquje, jeqHa BpcTa, MyxcjaK h xceHKa, HajnpHMjepeHHjn nyT npHMjeHe y3HMajyhn y oÔ3Hp BjepoBaTHH nyT H3qaraH>a q>yqn, o c h m ano cy noqaqn Beh qocTaBJbeHH y OKBupy 3axTjeBa H3 oqjeibKa B2.9.1. HcmiTHBaiBe KaHneporeHOCTH 2.9.1. PerncTpaHT Moxce npeqqoJKHTH, a MHHHCTapcTBO Moxte 3axTiijeBaTH

HCTpaJKHBa&e KaHqeporeHOCTH y CKqaqy ca nqaHOM 13. 3aKOHa o xeMHKannjaMa ano:- cyncTaHqa HMa rnnpoKy qncnep3HBHy npHMjeHy h b h nocToje qoKa3H o ynecTaqoM nqn qyroTpajHOM H3qaraH>y Jbyqn h

- je cyncTaHqa pa3BpcTaHa Kao MyTareH 3. KaTeropuje iu ih ano HCTpajKiiBaita t o k c h h h o c t h Koq noHOBibeHe npHMjeHe noKa3yjy qa cyncTaHqa Moace H3a3BaTH xnnepnqa3Hje h / h u h npeHeonqacranHe qe3nje.A k o je cyncTaHqa pa3BpcTaHa Kao MyTareH 1. h b h 2. KaTeropuje, Tpeôa npeTnocTaBHTH qa BjepoBaTHO nocTojn reHOTOKCHHHH MexaHH3aM 3a KaHqeporeHOCT. Y t o m cqynajy yrqaBHOM HHje noTpeÔHO cnpoBoqHTH HcnHTHBaae 3a KaHqeporeHOCT.

3. EKOTOKCHKOJIOIIIKH IIO,fl,AIIHKOJIOHA 1.

CTAHflAPflHH 3AXTJEBHKOJIOHA 2.

nOCEEHA nPABHJIA 3A OJICTYI IAIEE Ofl KOJIOHE 1.3.2 Pa3rpaqibH BO CT 3.2.1. E n o q o u iK a

3.2 P e rn c T p a H T h e n peqqoxcH TH q o q a T H o H cnH TH Ba& e Ô H oqou iK e

pa3rpaqq>HBOCTH a n o n p o u je H a 6e3Ô jeqH0CTH x eM H K aqq je y c n q a q y ca nqaHOM 26. 3aKOHa o x eM H K aqq jaM a yK a3 y je Ha n o T p e ô y 3a qoqaTH H M HCTpaJKHBaibeM pa3rpaqq>HBOCTH cy n c T a H q e h KbeHiix n p oH 3 B o qa pa3rpaqn >e. H 3 0 o p

H cm iT H B a fta 3aBHCH o q p e3 yq T a T a n p o q je H e 6e30jeqHOCTH xeM H K a q q je h m o m yKJbyHHBaTH CH M yqaqnoH O n cnH T H B a& e y o q r o B a p a jy h o j cpeqH H H (H n p . B oqa , ceqH M eH T h . h i 3eM JbHuiTe).

3.3 C yqÔ H H a h n o H a m a ite y a cH B orao j cpeqH H H

3.3.4. H o q a T H e H H tjjopM aqH je o

cyqÔHHH h n o H a m a ft y c y n cT a H q e h / h b h n p oH 3 B o qa p a 3 r p a q & e y aaiBO TH oj

cpeq iiH H

3.3.4. P e rn c T p a H T je qyxcaH npeqqoJKH TH , a M HHHCTapcTBO MOJKe 3axTq jeB aTH

q o q a T H o iicm iT H B a ib e y c n q a q y c a nqaHOM 13. 3aKO H a o x eM H K aqq jaM a aKO n p o q je H a 6e30jeqHOCTH xeM H K a q q je y c n q a q y ca nqaHOM 26. 3aKOHa o xeM H K an n jaM a yK a3 y je Ha n o T p e ô y 3a qoqaTH H M HCTpajKHBa&eM cyqÔ H H e h n o H a u ia a a cy n c T a H q e y xaiB O TH oj cpeqH H H . H 3 0 o p n cm iT H B a ib a 3aBHCH o q

_ p e 3 yq T a T a n p o q je n e 6e30jeqHOCTH xeM H K aqq je .

3.4 E(j)eKTH Ha K onH eH e opraH H 3M e 3.4 P e rn c T p a H T he npeqqoJKH TH HcnHTHBaKbe q y r o T p a jH e t o k c h h h o c t h aKO

p e3 yqTaTH n p o q je H e 6e30jeqHOCTH xeM H K a q q je y C K qaqy ca nqaHOM 26. 3aKOHa o x eM H K aqq jaM a y n a 3 y jy Ha n o T p e ô y 3a qoqaT H H M HCTpaJKHBa&eM etjienaTa cy n cT a H q e h / h . ih n p oH 3 B o q a pa3rpaqH >e Ha KonH eH e opraH H 3M e. I Î3 Ô o p

H cn H T H B aaa 3aB iicH o q p e3 yq T a T a n p o q je H e 6e30 jeqH 0CTH xeM H K aqn je .

O B a H cnH TH B a fta H n je noTpeÔ H O cn p oB oqH T H a n o q n p eK T H a h H H qnpeKTH a H3qoaceHOCT cerM eH Ta 3eM q,H iiiTa HHje B jepoB aTH a.

3.4.4. H c n H T H B a a e q y r o T p a jH e t o k c h h h o c t h Ha ôecK H H M eftaqH M a, o c h m a n o c y n o q a q n Beh qocTaB ibeH H y OKBHpy 3axT jeBa H3 o q je ib K a B 3.4.6. H c m iT H B a iie q y r o T p a jH e

TOKCHHHOCTH Ha ÔHJbKaMa, OCHM aKO c y n o q a q n Beh qocTaB ibeH H y OKBHpy

3axqjeB a H3 o q je ib K a B3.5.1. H y r o T p a jH a t o k c h h h o c t 3a

op raH H 3M e K o jn acHBe y ceqH M eH Ty3.5.1. P e rn c T p a H T h e npeqqoJKH TH n cn H T H B a fte q y r o T p a jH e t o k c h h h o c t h a x o pe3 yqTaTH n p o q je H e 6e30jeqHOCTH xeM H K aqn je y n a 3 y jy Ha n o T p e ô y 3a qoqaTH H M HCTpaxaœaHbeM etjjeKaTa cy n c T a H q e h / m m rqaBH H X n p oH 3 B oqa p a 3 rp a qH ,e Ha opraH H 3M e K o jn jKHBe y ceqH M eH Ty. P b ô o p HcnHTHBan>a 3aBMCH o q p e 3 y q T a T a n p o q je H e 6e30jeqHOCTH xeM H K aqn je .

3.6.1. / ly r o T p a jn a h a h p en p oqyK T H B H a t o k c h h h o c t 3a n T n q e

3.6.1. T p e ô a naxtibHBO pa3M OTpHTH cB aK y n o T p e ô y 3a H cnuTH Ba& eM , y3H M ajyhn y oÔ 3np B equ K y K o q u n iiH y n o q a T a K a 3a c n c a p e n o ja j e o ô h h h o p a c n o q o x a iB a 3a OBy KoqHHHHCKy rp y n y .

H a n o M eH a :

PerncTpaHT Ha HHBoy o b o t oqjeibKa Mopa noqHqjera npnjeqjior h BpeMeHCKH pacnopeq 3a HcnyrbaBaite 3axT jeB a H3 o b o t oqjejBKa y cnqaqy ca nqaHOM 5. CTaB 1. Tanna r).K o q o H a 1. o b o t o q je ib K a yT B p tjy je CTaH qapqH e n oq a T K e n o T p e ô n e 3a CBe cy n cT a H q e npoH 3 B eqeH e unu yB e3en e y KoqHHHHaM a o q 1.000 TOHa ¡inn BHm e y C K qaqy c a nqaHOM 5. o b o t npaBH qH H na. I I o q a q H 3axTqjeBaH H y k o b o h h 1. o b o t o q je ib K a c y q o q a T a n n o q a u n M a 3axT «jeB aH H M y k o b o h h 1. o q je ib a K a A, E u B o b o t n p H q o ra .