1996L0077 — EN — 20#11#2003 — 00$#001 — 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents ►B C O M M IS S IO N I! E C TI" E # $ %& & %E C of ' ecember ( # # $ layin) do* n specific purity criteria on food additi+ es other than colours and s* eeteners ,Te- t * ith E E . rele+ ance/ %O & L 339' 30#12#1996' ! # 1( ) " e n * e * b + : O ffic ia l &o u rn a l No ! a , e * a te ►M ( C o " " issio n - ire c ti. e 9/ // 6/EC o f 11 No . e " b e r 199/ L 330 1 9#12#199/ ►M ' C o " " issio n - ire c ti. e 2000/63/EC o f $ O c to b e r 2000 L 277 1 30#10#2000 ►M 0 C o " " issio n - ire c ti. e 2001/30/EC o f 2 1 a + 2001 L 10 6 1 31#$#2001 ►M 1 C o " " issio n - ire c ti. e 2002// 2/EC o f 1$ O c to b e r 2002 L 292 1 2/ #10#2002 ►M 2 C o " " issio n - ire c ti. e 2003/9$/EC o f 27 O c to b e r 2003 L 2/ 3 71 31#10#2003 1996L0077 — EN — 20#11#2003 — 00$#001 — 2 ▼B COMMISSION I!ECTI"E #$%&&%EC of ' ecember (##$ layin) do*n specific purity criteria on food additi+es other than colours and s*eeteners ,Te-t *ith EE. rele+ance/ 23E CO114SS4ON O5 23E E67OPE)N CO116N424ES' 3a.in, re,ar* to t e 2reat+ establis in, t e Euro!ean Co""unit+' 3a.in, re,ar* to Council -irecti.e /9/107/EEC of 21 -ece"ber 19// on t e a!!ro8 i"ation of t e la9 s of t e 1e"ber States concernin, foo* a**iti.es aut ori: e* for use in foo*stuffs inten*e* for u"an consu"!tion %1(' as a"en*e* b+ Euro!ean Parlia"ent an* Council -irecti.e 90/30/EC %2(' an* in !articular )rticle 3 %3( %a( t ereof' )fter consultin, t e Scientific Co""ittee for 5oo*' ; ereas it is necessar+ to establis !urit+ criteria for all a**iti.es ot er t an colours an* s9 eeteners "entione* in Euro!ean Parlia"ent an* Council -irecti.e 9$/2/EC of 20 5ebruar+ 199$ on foo* a**iti.es ot er t an colours an* s9 eeteners %3(< ; ereas it is necessar+ to re!lace t e !urit+ criteria set out in Council -irecti.e 6$/66/EEC of 26 &anuar+ 196$ la+in, *o9 n s!ecific criteria of !urit+ for !reser.ati.es aut ori: e* for use in foo*stuffs inten*e* for u"an consu"!tion %0(' as last a"en*e* b+ -irecti.e /6/600/EEC %$(< ; ereas it is necessar+ to re!lace t e !urit+ criteria set out in Council -irecti.e 7//660/EEC of 2$ &ul+ 197/ la+in, *o9 n s!ecific criteria of !urit+ for antio8 i*ants 9 ic "a+ be use* in foo*stuffs inten*e* for u"an consu"!tion %6(' as a"en*e* b+ -irecti.e /2/712/EEC %7(< ; ereas -irecti.es 6$/66/EEC an* 7//660/EEC s oul* be re!eale* accor*in,l+< ; ereas it is necessar+ to ta= e into acount t e s!ecifications an* anal+tical tec ni> ues for a**iti.es as set out in t e Codex Alimentarius as *rafte* b+ t e &oint 5)O/; 3O E8 !ert Co""ittee on 5oo* )**i? ti.es %&ecfa(< ; ereas foo* a**iti.es' if !re!are* b+ !ro*uction "et o*s or startin, "aterials si,nificantl+ *ifferent fro" t ose inclu*e* in t e e.aluation of t e Scientific Co""ittee for 5oo*' or if *ifferent fro" t ose "entione* in t is -irecti.e' s oul* be sub"itte* for e.aluation b+ t e Scientific Co""ittee for 5oo* for t e !ur!oses of a full e.aluation 9 it e"! asis on t e !urit+ criteria< ; ereas' t e "easures !ro.i*e* for in t is -irecti.e are in accor*ance 9 it t e o!inion of t e Stan*in, Co""ittee for 5oo*stuffs' 3)S )-OP2E- 234S -47EC24@ E: Artic le 1 2 e !urit+ criteria referre* to in )rticle 3 %3( %a( of -irecti.e /9/107/ EEC for foo* a**iti.es ot er t an colours an* s9 eeteners' as "entione* in -irecti.e 9$/2/EC' are set out in t e )nne8 ereto# %1( O& No L 00' 11# 2# 19/9' !# 27# %2( O& No L 237' 10# 9# 1990' !# 1# %3( O& No L 61' 1/# 3# 199$' !# 1# %0( O& No 22' 9# 2# 196$' !# 373# %$( O& No L 3$2' 13# 12# 19/6' !# 0$# %6( O& No L 223' 10# /# 197/' !# 30# %7( O& No L 297' 23# 10# 19/2' !# 31# 1996L0077 — EN — 20#11#2003 — 00$#001 — 3 ▼M( Article 2 2 e !urit+ criteria referre* to in )rticle 1 re!lace t e !urit+ criteria set out in -irecti.es 6$/66/EEC' 7//663/EEC an* 7//660/EEC# ▼B Article 3 1# 1e"ber States s all brin, into force t e la9s' re,ulations an* a*"inistrati.e !ro.isions necessar+ to co"!l+ 9it t is -irecti.e before 1 &ul+ 1997# 2 e+ s all i""e*iatel+ infor" t e Co""ission t ereof# ; en 1e"ber States a*o!t t ese !ro.isions' t ese s all contain a reference to t is -irecti.e or s all be acco"!anie* b+ suc reference at t e ti"e of t eir official !ublication# 2 e !roce*ure for suc refer? ence s all be a*o!te* b+ 1e"ber States# 2# Pro*ucts !ut on t e "ar=et or labelle* before 1 &ul+ 1997 9 ic *o not co"!l+ 9it t is -irecti.e "a+ be "ar=ete* until stoc=s are e8 auste*# Article 4 2 is -irecti.e s all enter into force on t e 20t *a+ follo9in, t at of its !ublication in t e O fficial J ournal of th e urop ean Communities# Article 5 2 is -irecti.e is a**resse* to t e 1e"ber States# 1996L0077 — EN — 20#11#2003 — 00$#001 — 0 ▼B ANN ! E '3 3 SO!BIC .CI efinition Chemical name Sorbic aci* 2rans' trans?2'0? e8a*ienoic aci* Einecs 203?76/?7 Chemical formula C63/O2 " olecular # eig ht 112'12 Assa$ Content not less t an 99 A on t e an +*rous basis % escription Colourless nee*les or 9 ite free flo9in, !o9*er' a.in, a sli, t c aracteristic o*our an* s o9in, no c an,e in colour after eatin, for 90 "inutes at 10$ BC Identification )# 1eltin, ran,e C et9een 133 BC an* 13$ BC' after .acuu" *r+in, for four ours in a sul! uric aci* *esiccator C # S!ectro"etr+ )n iso!ro!anol solution %1 in 0 000 000( s o9s absor? bance "a8i"u" at 2$0 D 2 n" C# Positi.e test for *ouble bon*s -# Subli"ation !oint /0 BC P urity ;ater content Not "ore t an 0'$ A %Earl 5isc er "et o*( Sul! ate* as Not "ore t an 0'2 A )l*e +*es Not "ore t an 0'1 A %as for"al*e +*e( )rsenic Not "ore t an 3 ",/=, Lea* Not "ore t an $ ",/=, 1ercur+ Not "ore t an 1 ",/=, 3ea.+ "etals %as Pb( Not "ore t an 10 ",/=, E '3 ' P OT.SSI4 M SO!B.TE efinition Chemical name Potassiu" sorbate Potassiu" %E'E(?2'0? e8a*ienoate Potassiu" salt of trans' trans 2'0? e8a*ienoic aci* Einecs 206?376?1 Chemical formula C637O2E " olecular # eig ht 1$0'22 Assa$ Content not less t an 99 A on t e *rie* basis % escription ; ite cr+stalline !o9*er s o9in, no c an,e in colour after eatin, for 90 "inutes at 10$ BC Identification )# 1eltin, ran,e of sorbic aci* isolate* b+ aci*ification an* not recr+stalli:e* 133 BC to 13$ BC after .acuu" *r+in, in a sul! uric aci* *esiccator C # Positi.e tests for !otassiu" an* for *ouble bon*s 1996L0077 — EN — 20#11#2003 — 00$#001 — $ ▼B Purity Loss on *r+in, Not "ore t an 1'0 A %10$ BC' 3 ( )ci*it+ or al=alinit+ Not "ore t an about 1'0 A %as sorbic aci* or E2CO3( )l*e +*es Not "ore t an 0'1 A' calculate* as for"al*e +*e )rsenic Not "ore t an 3 ",/=, Lea* Not "ore t an $ ",/=, 1ercur+ Not "ore t an 1 ",/=, 3ea.+ "etals %as Pb( Not "ore t an 10 ",/=, E '30 C.L CI4M SO!B.TE efinition Chemical name Calciu" sorbate Calciu" salts of trans' trans?2'0? e8a*ienoic aci* Einecs 231?321?6 Chemical formula C12310O0Ca "olecular #eight 262'32 Assa$ Content not less t an 9/ A on t e *rie* basis %escription 5ine 9 ite cr+stalline !o9*er not s o9in, an+ c an,e in colour after eatin, at 10$ BC for 90 "inutes Identification )# 1eltin, ran,e of sorbic aci* isolate* b+ aci*ification an* not recr+stalli:e* 133 BC to 13$ BC after .acuu" *r+in, in a sul! uric aci* *esiccator C# Positi.e tests for calciu" an* for *ouble bon*s Purity Loss on *r+in, Not "ore t an 2'0 A' *eter"ine* b+ .acuu" *r+in, for four ours in a sul! uric aci* *esiccator )l*e +*es Not "ore t an 0'1 A %as for"al*e +*e( 5luori*e Not "ore t an 10 ",/=, )rsenic Not "ore t an 3 ",/=, Lea* Not "ore t an $ ",/=, 1ercur+ Not "ore t an 1 ",/=, 3ea.+ "etals %as Pb( Not "ore t an 10 ",/=, E '(3 BEN5 OIC .CI efinition Chemical name Cen:oic aci* Cen:enecarbo8+lic aci* P en+lcarbo8+lic aci* Einecs 200?61/?2 Chemical formula C736O2 "olecular #eight 122'12 Assa$ Content not less t an 99'$ A on t e an +*rous basis %escription ; ite cr+stalline !o9*er 1996L0077 — EN — 20#11#2003 — 00$#001 — 6 ▼B Identification )# 1eltin, ran,e 121'$ BC to 123'$ BC C# Positi.e subli"ation test an* test for ben:oate Purity Loss on *r+in, Not "ore t an 0'$ A after *r+in, for t ree ours o.er sul! uric aci* !3 )bout 0 %solution in 9ater( Sul! ate* as Not "ore t an 0'0$ A C lorinate* or,anic co"!oun*s Not "ore t an 0'07 A e8!resse* as c lori*e corre? s!on*in, to 0'3 A e8!resse* as "onoc loroben:oic aci* 7ea*il+ o8i*i:able substances )** 1'$ "l of sul! uric aci* to 100 "l of 9ater' eat to boilin, !oint an* a** 0'1 N E1nO0 in *ro!s' until t e !in= colour !ersists for 30 secon*s# -issol.e 1 , of t e sa"!le' 9ei, e* to t e nearest ",' in t e eate* solution' an* titrate 9it 0'1 N E1nO0 to a !in= colour t at !ersists for 1$ secon*s# Not "ore t an 0'$ "l s oul* be re>uire* 7ea*il+ carboni:able substances ) col* solution of 0'$ , of ben:oic aci* in $ "l of 90'$ to 9$'$ A sul! uric aci* "ust not s o9 a stron,er colourin, t an t at of a reference li>ui* containin, 0'2 "l of cobalt c lori*e 2SC %1(' 0'3 "l of ferric c lori*e 2SC %2(' 0'1 "l of co!!er sul! ate 2SC %3( an* 0'0 "l of 9ater Pol+c+clic aci*s On fractional aci*ification of a neutrali:e* solution of ben:oic aci*' t e first !reci!itate "ust not a.e a *ifferent "eltin, !oint fro" t at of t e ben:oic aci* )rsenic Not "ore t an 3 ",/=, Lea* Not "ore t an $ ",/=, 1ercur+ Not "ore t an 1 ",/=, 3ea.+ "etals %as Pb( Not "ore t an 10 ",/=, E '(( SO I4M BEN5O.TE efinition Chemical name So*iu" ben:oate So*iu" salt of ben:enecarbo8+lic aci* So*iu" salt of ! en+lcarbo8+lic aci* Einecs 20/?$30?/ Chemical formula C73$O2Na "olecular #eight 100'11 Assa$ Not less t an 99 A of C73$O2Na' after *r+in, at 10$ BC for four ours %escription ) 9 ite' al"ost o*ourless' cr+stalline !o9*er or ,ran? ules