The EFSA Journal (2009) 938, 1-16
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SCIENTIFIC OPINION Safety of ‘Lipid extract from Euphausia superba' as a novel food ingredient 1 Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Question No EFSA-Q-2008-027)
Adopted on 22 January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`]*9[a! _]! 9! _7! C^_66CM!)*,!,&H&;)2(W)(*&3H!)H3,!KT@14!S55`b*9[a!c9_b!C^_66CML!O2(!I)d&%!)I&$*/;!&.!/2(;(! .)//0!)H3,;!)%(!'%(;(*/!3*!'2&;'2&=3'3,;L!S&I'&;3/3&*)=!,)/)!&*!I)d&%!H&I'&*(*/;!&.!UAYZ! );!Q(==!);!&*!I3*&%!H&I'&*(*/;!K(LCL!$*;)'&*3.3)>=(!I)//(%M!2)E(!>((*!'%&E3,(,!)*,!)!>%&),! ;'(H/%$I! &.! '&/(*/3)=! H&*/)I3*)*/;! 2);! >((*! )*)=0;(,L! O2(! ')%)I(/(%;! '%(;(*/(,! ;$..3H3(*/=0! H2)%)H/(%3;(!/2(!'%&,$H/!)*,!,(I&*;/%)/(!3/;!H&*;3;/(*H0!)*,!;/)>3=3/0L! O2(! )''=3H)*/! %(E3(Q(,! ,)/)! &*! )>;&%'/3&*4! ,3;/%3>$/3&*! )*,! (=3I3*)/3&*4! ,)/)! .%&I! /&W3H3/0! ;/$,3(;!)*,!,)/)!.%&I!H=3*3H)=!2$I)*!;/$,3(;!'(%.&%I(,!Q3/2!/2(!I)d&%!H&I'&*(*/;!&.!UAYZ4! 3L(L!'2&;'2&=3'3,;4!#B1!)*,!T@14!)*,!Q3/2!/2(!H)%&/(*&3,!);/)W)*/23*L!! O2(! /&W3H&=&C3H)=! ,)/)! '%&E3,(,! .&%! UAYZ! )%(! =3I3/(,! /&! )! %('()/9,&;(! ;/$,0! K;3W! I&*/2;M! H&*,$H/(,! Q3/2! S]c<:^b! *$,(! H&*C(*3H! I3H(! K
!! +&%! H3/)/3&*! '$%'&;(;`! -H3(*/3.3H! Y'3*3&*! &.! /2(! B)*(=! &*! T3(/(/3H! B%&,$H/;! U$/%3/3&*! )*,! 1==(%C3(;! &*! )! %(R$(;/! .%&I! /2(! #$%&'()*!S&II3;;3&*!&*!/2(!;).(/0!&.!V:3'3,!(W/%)H/!.%&I Euphasia superbaX!);!.&&,!3*C%(,3(*/L!The EFSA Journal!K5667M! 7[\4!_9_bL!
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Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
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The EFSA Journal K5667M!7[\4!59_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
O2(!B)*(=!H&*H=$,(;!/2)/!/2(!=3'3,!(W/%)H/!.%&I!#$'2)$;3)!;$'(%>)!K1*/)%/3H!A%3==4!UAYZM!);!)! *&E(=!.&&,!3*C%(,3(*/!3;!;).(!$*,(%!/2(!;'(H3.3(,!H&*,3/3&*;!&.!$;(L!! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !
Key words: Euphausia superba, 1*/)%/3H! A%3==4! =3'3,! (W/%)H/4 (3H&;)'(*/)(*&3H! )H3,! K#B1M4! ,&H&;)2(W)(*&3H!)H3,!KT@1M4!'2&;'2&=3'3,;!
The EFSA Journal K5667M!7[\4![9_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
TABLE OF CONTENTS B)*(=!?(I>(%;LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL_ ! -$II)%0 LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL_ ! O)>=(!&.!S&*/(*/; LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLj ! <)HFC%&$*,!);!'%&E3,(,!>0!/2(!H&II3;;3&*LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL] ! O(%I;!&.!%(.(%(*H(!);!'%&E3,(,!>0!/2(!H&II3;;3&*LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL] ! 1HF*&Q=(,C(I(*/; LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLb ! 1;;(;;I(*/ LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLb ! NL! -'(H3.3H)/3&*!&.!/2(!*&E(=!.&&,!KU+M LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLb ! NNL! #..(H/!&.!/2(!'%&,$H/3&*!'%&H(;;!)''=3(,!/&!/2(!U+ LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL__ ! NNNL! @3;/&%0!&.!/2(!&%C)*3;I!$;(,!);!/2(!;&$%H(!&.!/2(!U+ LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL__ ! NkL! 1*/3H3')/(,!3*/)F(^(W/(*/!&.!$;(!&.!/2(!U+ LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL__ ! kL!! N*.&%I)/3&*!.%&I!'%(E3&$;!2$I)*!(W'&;$%(!/&!/2(!U+!&%!3/;!;&$%H(LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL_5! kNL! U$/%3/3&*)=!3*.&%I)/3&*!&*!/2(!U+LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL_[ ! kNNL! ?3H%&>3&=&C3H)=!3*.&%I)/3&*!&*!/2(!U+LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL_[ ! kNNNL!O&W3H&=&C3H)=!3*.&%I)/3&*!&*!/2(!U+ LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL_[ ! T3;H$;;3&* LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL_j! S&*H=$;3&*;!)*,!G(H&II(*,)/3&*;LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL_] ! T&H$I(*/)/3&*!'%&E3,(,!/&!#+-1 LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL_] ! G(.(%(*H(; LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL_]!
The EFSA Journal K5667M!7[\4!j9_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
BACKGROUND AS PROVIDED BY THE COMMISSION Y*! c! U&E(I>(%! 566b4! U('/$*(! O(H2*&=&C3(;! l! <3&%(;&$%H(;! N*HL! ;$>I3//(,! )! %(R$(;/! $*,(%! 1%/3H=(!j!&.!/2(!U&E(=!+&&,!G(C$=)/3&*!K#SM!Um!5]\^7c!/&!/2(!H&I'(/(*/!)$/2&%3/3(;!&.!+3*=)*,! .&%!'=)H3*C!&*!/2(!I)%F(/!)!V:3'3,!(W/%)H/!.%&I Euphausia superbaX!);!.&&,!3*C%(,3(*/L! Y*! 57! 8)*$)%0! 566c4! /2(! H&I'(/(*/! )$/2&%3/3(;! &.! +3*=)*,! .&%Q)%,(,! /&! /2(! S&II3;;3&*! 3/;! 3*3/3)=! );;(;;I(*/!%('&%/4!Q23H2!H)I(!/&!/2(!H&*H=$;3&*!/2)/!/2(!%(;()%H2!%(;$=/;!'%(;(*/(,!>0! /2(!)''=3H)*/!,&!*&/!%)3;(!)*0!,&$>/;!)>&$/!/2(!'%&,$H/X;!;).(/0L! Y*! _7! +(>%$)%0! 566c4! /2(! S&II3;;3&*! .&%Q)%,(,! /2(! 3*3/3)=! );;(;;I(*/! %('&%/! /&! /2(! &/2(%! ?(I>(%! -/)/(;L! -(E(%)=! &.! /2(! ?(I>(%! -/)/(;! ;$>I3//(,! ),,3/3&*)=! H&II(*/;! &%! %)3;(,! &>d(H/3&*;L! O2(!H&*H(%*;!&.!)!;H3(*/3.3H!*)/$%(!%)3;(,!>0!/2(!S&I'(/(*/!1$/2&%3/3(;!&.!?(I>(%!-/)/(;!H)*! >(!;$II)%3;(,!);!.&==&Q;`! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !
+$%/2(%!;'(H3.3H)/3&*!&.!/2(!'2&;'2&=3'3,;L!! n$)=3/)/3E(!)*,!R$)*/3/)/3E(!,)/)!&*!/2(!'%(;(*H(!&.!*&*9=3'3,!H&*;/3/$(*/;L!! T)/)!&*!/2(!)H3,!E)=$(L! T)/)!&*!/2(!'$%3/0!&.!/2(!&3=L!! T)/)!&*!/2(!'&/(*/3)=!)HH$I$=)/3&*!&.!I)%3*(!>3&/&W3*;!3*!F%3==!)*,!,)/)!&*!/2(! )*)=0;3;!&.!/2(;(!/&W3*;!3*!/2(!.3*)=!'%&,$H/L!! T)/)!&*!/2(!'%(;(*H(!&.!&%C)*3H!)%;(*3HL!!! N/!3;!R$(;/3&*(,!Q2(/2(%!/2(!=3I3/(,!23;/&%0!&.!H&*;$I'/3&*!&.!F%3==!3;!;$..3H3(*/! /&!,(I&*;/%)/(!/2(!;).(/0!&.!/2(!&3=L!! n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
!! N*! H&*;(R$(*H(4! )! S&II$*3/0! T(H3;3&*! 3;! *&Q! %(R$3%(,! $*,(%! 1%/3H=(! c4! ')%)C%)'2! _! &.! G(C$=)/3&*!K#SM!U&!5]\^7cL!!!!! TERMS OF REFERENCE AS PROVIDED BY THE COMMISSION N*! )HH&%,)*H(! Q3/2! 1%/3H=(! 57! K_M! K)M! &.! G(C$=)/3&*! K#SM! U&! _c\^56654! /2(! #$%&'()*! +&&,! -).(/0! 1$/2&%3/0! 3;! );F(,! /&! H)%%0! &$/! /2(! ),,3/3&*)=! );;(;;I(*/! .&%! V:3'3,! (W/%)H/! .%&I Euphausia superbaX!);!.&&,!3*C%(,3(*/!3*!/2(!H&*/(W/!&.!G(C$=)/3&*!K#SM!Um!5]\^7cL! #+-1!3;!);F(,!/&!H&*;3,(%!/2(!(=(I(*/;!&.!;H3(*/3.3H!*)/$%(!3*!/2(!H&II(*/;!%)3;(,!>0!/2(!&/2(%! ?(I>(%!-/)/(;L!
The EFSA Journal K5667M!7[\4!]9_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
ACKNOWLEDGEMENTS O2(!#$%&'()*!+&&,!-).(/0!1$/2&%3/0!Q3;2(;!/&!/2)*F!/2(!I(I>(%;!&.!/2(!o&%F3*C!p%&$'!.&%! /2(! '%(')%)/3&*! &.! /23;! &'3*3&*`! 8()*9:&$3;! <%(;;&*4! A)%=9@(3*J! #*C(=4! ?)%3*)! @(3*&*(*4! B)C&*)!:)C3&$4!<(E)*!?&;(=(04!1*,%($!B)=&$4!1**(//(!Bq/3*C4!-(''&!-)=I3*(*4!@(*,%3F!P)*! :&E(%(*!)*,!@)*;!P(%2)C(*L ASSESSMENT O2(!*&E(=!.&&,!3*C%(,3(*/!3;!)*!&3=!(W/%)H/(,!.%&I!/2(!H%$;/)H()*!Euphausia superba!K1*/)%H/3H! A%3==ML!O2(!*)I(!'%&'&;(,!3;!U('/$*(!A%3==!Y3=!KUAYZML! UAYZ! 3;! )! H&I'=(W! *&E(=! .&&,! 3*C%(,3(*/! ,(%3E(,! .%&I! )*! )*3I)=4! Q23H2! 2);! *&/! >((*! C(*(/3H)==0! I&,3.3(,L! N/! 2);4! /2(%(.&%(4! >((*! );;3C*(,! /&! H=);;! 54! );! ,(.3*(,! 3*! /2(! %(H&II(*,)/3&*;! &.! /2(! -H3(*/3.3H! S&II3//((! .&%! +&&,! K-S+M! H&*H(%*3*C! /2(! );;(;;I(*/! &.! *&E(=!.&&,;!K#$%&'()*!S&II3;;3&*4!_77cML!N/!>(=&*C;!/&!;$>9H)/(C&%0!5L54!>(H)$;(!/2(!;&$%H(! &.!/2(!*&E(=!.&&,!2);!*&!23;/&%0!&.!.&&,!$;(!Q3/23*!/2(!S&II$*3/0L!1HH&%,3*C=04!3*.&%I)/3&*! %(=)/(,!/&!/2(!;/%$H/$%(,!;H2(I(;!N4!NN4!NNN4!Nk4!kN4!kNN!)*,!kNNN!2);!>((*!;$>I3//(,L!!! I.
Specification of the novel food (NF)
Y*(!&.!/2(!I)3*!.()/$%(;!&.!UAYZ!3;!/2)/!/2(!H&*/(*/!&.!/%3C=0H(%3,(;!3;!=&Q!K)''%&W3I)/(=0!! [c! fM! Q2(%();! /2(! H&*/(*/! &.! '2&;'2&=3'3,;! 3;! %)/2(%! 23C2L! +&%! /2%((! >)/H2(;! /2(! )E(%)C(! H&*/(*/!&.!/&/)=!'2&;'2&=3'3,;!Q);!;2&Q*!/&!>(![7L]!f!KO)>=(!_ML!1HH&%,3*C!/&!,)/)!'%&E3,(,! .&%!/Q&!;)I'=(;4!/2(!'2&;'2&=3'3,;!)%(!H&I'&;(,!&.!)''%&W3I)/(=0!c5!f!'2&;'2)/3,0=H2&=3*(4! 55!f!'2&;'2)/3,0=(/2)*&=)I3*(4!_!f!'2&;'2)/3,0=3*&;3/&=!)*,!]!f!H)%,3&=3'3*L!! 1*&/2(%!H2)%)H/(%3;/3H!'%&'(%/0!3;!/2(!23C2!H&*/(*/!&.!'&=0$*;)/$%)/(,!.)//0!)H3,;4!3*!')%/3H$=)%! (3H&;)'(*/)(*&3H!)H3,!K#B14!S56`]*9[M!)*,!,&H&;)2(W)(*&3H!)H3,!KT@14!S55`b*9[ML!1;!;2&Q*! 3*!O)>=(!_4!/2(!I)d&%!)I&$*/;!&.!/2(;(!.)//0!)H3,;!)%(!'%(;(*/!3*!'2&;'2&=3'3,;L! O)>=(!_L Batch ! ! ! EPA DHA !
Phospholipid contents of NKO™ and proportions of EPA and DHA present in phospholipids 060116
060127
060822
! [7L5!
Phospholipids (%) [7Lc! % of total fatty acids present in phospholipids c6L]! c_L5!
! [7L]!
! b7L5! b\Lj!
! b\L5! bbL[!
S&I'&;3/3&*)=!,)/)!%(;$=/3*C!.%&I!/2(!)*)=0;3;!&.!/2%((!>)/H2(;!&.!UAYZ!)%(!;2&Q*!3*!O)>=(! 5L!O2(!)*)=0;(;!Q(%(!'(%.&%I(,!>0!(W'(%3(*H(,!(W/(%*)=!=)>&%)/&%3(;4!$;3*C!;/)*,)%,!I(/2&,;L!! !
The EFSA Journal K5667M!7[\4!b9_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
O)>=(!5L!! Compositional data of three batches of NKO™! !
060116
060519
060224
O&/)=!'2&;'2&=3'3,;!
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6Lb!C^_66!C!
6L]!C^_66!C!
6Lb!C^_66!C!
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The EFSA Journal K5667M!7[\4!c9_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
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The EFSA Journal K5667M!7[\4!\9_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
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Microbial parameters
!
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Listeria monocytogenes
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O2(!.)//0!)H3,!,3;/%3>$/3&*;!3*!/2(!/&/)=!'%&,$H/!);!Q(==!);!3*!/2(!'2&;'2&=3'3,;!Q(%(!;2&Q*!/&! >(!H&*;3;/(*/!3*!/2(;(!>)/H2(;L! O2(! $*;)'&*3.3)>=(! I)//(%! &.! UAYZ! Q);! ,(/(%I3*(,! /&! >(! 5Lc! f! K>0! I);;ML! -(')%)/3&*! >0! ;3=3H)! C(=! H2%&I)/&C%)'20! )*,! )*)=0;3;! &.! /2(! .%)H/3&*;! &>/)3*(,! >0! pS^?-! %(;$=/(,! 3*! /2(! 3,(*/3.3H)/3&*!&.!/2(!H&I'&*(*/;!;2&Q*!3*!O)>=(!jL! O)>=(!jL!! Components of the unsaponifiable matter of NKO™ (batch 070219)! Component Fatty alcohols
% of unsaponifiable matter !
% of NKO™ !
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The EFSA Journal K5667M!7[\4!79_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
#%$H)I3,(!
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6L67!
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7\L7!
5Lc!
Sterols
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jL! #E(%0! =&/! /2)/! 3;! 3I'&%/(,! 2);! /&! >(! ,(H=)%(,L! O2(! %(;$=/;! &.! )==! /(;/;! K1I*(;3H! -2(==.3;2! B&3;&*3*C4! 1-Ba! B)%)=0/3H!-2(==.3;2!B&3;&*3*C4!B-Ba!,&I&3H!)H3,M!2)E(!>((*!)HH('/)>=(L! O2(! ;'(H3.3H)/3&*! K"! 6L_! IC^FCM! C3E(*! .&%! )%;(*3H! 3*! O)>=(! 5! %(.(%;! /&! 3*&%C)*3H! )%;(*3HL! O2(! '%(,&I3*)*/!.&%I!&.!)%;(*3H!3*!.3;2!)*,!;2(==9.3;2!,(%3E(,!'%&,$H/;!3;!&%C)*3HL!1HH&%,3*C!/&!/2(! )''=3H)*/4!UAYZ!I)0!H&*/)3*!$'!/&!_6!IC^FC!&.!/&/)=!)%;(*3HL!N/!3;!Q&%/2Q23=(!/&!%(H)==!/2)/!3*! .3;2!)*,!;().&&,!&./(*!I&%(!/2)*!76!f!&.!/2(!/&/)=!)%;(*3H!;$>;/)*H(;!%('%(;(*/!/2(!*&*9/&W3H! )%;(*&>(/)3*(!)*,!)%;(*&H2&=3*(!K<$H2(/!)*,!:)$Q(%0;4!_77ja!#+-1!566])ML! #,3>=(!&3=;!)%(!*&%I)==0!H2)%)H/(%3J(,!>0!=&Q!H&*/(*/;!&.!.%((!.)//0!)H3,;4!(W'%(;;(,!>0!/2(!)H3,! E)=$(! K/0'3H)=! ;'(H3.3H)/3&*! .&%! .3;2! &3=`! 69]!IC! AY@^CML! O2(! )H3,! E)=$(! C3E(*! .&%! UAYZ! 3;! I$H2! 23C2(%! K5]Lc9[5Lj! IC! AY@^CM! &Q3*C! /&! /2(! 3*2(%(*/! H&*/(*/! &.! .%((! .)//0! )H3,;L! O2(%(.&%(4!/23;!')%)I(/(%!3;!=(;;!)''%&'%3)/(!);!;/)>3=3/0!3*,3H)/&%L!! O2(!&W3,)/3E(!;/)>3=3/0!&.!UAYZ!3;!%(.=(H/(,!>0!/2(!=&Q!'(%&W3,(!)*,!p9)*3;3,3*(!E)=$(;L!N/!2);! )=;&!>((*!;$''&%/(,!>0!;/)>3=3/0!,)/)!&*!UAYZ!3*!;&./!C(=)/3*(!H)';$=(;L!!!
The EFSA Journal K5667M!7[\4!_69_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
-3I3=)%!/&!/2(!'%&E3;3&*!3*!S&II3;;3&*!,(H3;3&*!566[^j5c^#S!&.!]!8$*(!566[!)$/2&%3;3*C!/2(! '=)H3*C!&*!/2(!I)%F(/!&.!&3=!%3H2!3*!T@1!.%&I!/2(!I3H%&)=C)!Schizochytrium!;'L!);!*&E(=!.&&,! K#$%&'()*! S&II3;;3&*4! 566[M4! /2(! )''=3H)*/! ;$CC(;/;! /2(! .&==&Q3*C! ;/)/(I(*/! h1==! .&&,! '%&,$H/;! H&*/)3*3*C! U('/$*(! A%3==! Y3=! ;2&$=,! ,(I&*;/%)/(! &W3,)/3E(! ;/)>3=3/0! >0! )''%&'%3)/(! )*,!%(H&C*3J(,!*)/3&*)=^3*/(%*)/3&*)=!/(;/!I(/2&,&=&C3(;!K(LCL!1Y1SMiL! II.
Effect of the production process applied to the NF
1HH&%,3*C!/&!/2(!)''=3H)*/4!/2(!F%3==!;Q)%I;!)%(!;&!,(*;(4!/2)/!&/2(%!.&&,!H&I'(/3/&%;4!;$H2!);! d(==0.3;24! ;I)==! .3;2! &%! ;R$3,! )%(! $;$)==0! (WH=$,(,L! Y*! /2(! %)%(! &HH);3&*;! &.! >09H)/H2(;4! /2(! H&*/)I3*)*/;!K;I)==!;'(H3(;!&.!.3;2!)*,!;R$3,M!H)*!>(!%(),3=0!&>;(%E(,!>0!E3;$)=!3*;'(H/3&*!)*,! >(!,3;H)%,(,L! O2(! ,(('9.%&J(*! %)Q! 1*/)%H/3H! F%3==! 3;! H%$;2(,! )*,! ;$>d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p&&,! ?)*$.)H/$%3*C!B%)H/3H(;!Kp?BML! III.
History of the organism used as the source of the NF
UAYZ!3;!'%&,$H(,!.%&I!Euphausia superba!K1*/)%H/3H!A%3==M!Q23H2!3;!*)/3E(!/&!/2(!1/=)*/3H! ;(H/3&*!&.!/2(!1$;/%)=91*/)%H/3H!S3%H$I'&=)%!YH()*L!1HH&%,3*C!/&!/2(!)''=3H)*/4!1*/)%H/3H!A%3==! 2);! )! 23;/&%0! &.! H&*;$I'/3&*! );! .&&,! 3*! 8)')*4! G$;;3)4! eF%)3*(! )*,! +%)*H(! ;3*H(! /2(! I3,9 _7c6t;L! Y.! )>&$/! 564666! /&! [64666! /&*;! &.! '%&,$H/;! .%&I! F%3==! $;(,! )**$)==0! 3*! 8)')*! 3*! /2(! _7\6t;4!j666!r!b666!/&*;!2)E(!>((*!$/3=3J(,!);!2$I)*!.&&,!K-$J$F3!)*,!-23>)/)4!_776a!U3H&=! )*,!#*,&4!_77cML! IX.
Anticipated intake/extent of use of the NF
O2(! .&&,! C%&$';! /&! Q23H2! UAYZ! 3;! 3*/(*,(,! /&!>(!),,(,!)*,!/2(!I)W3I$I!=(E(=;!&.! T@1! )*,!#B1!'%&'&;(,!>0!/2(!)''=3H)*/!)%(!=3;/(,!3*!O)>=(!]L!O2(0!)%(!3*!)HH&%,)*H(!Q3/2!/2(!$;(!&.! &3=!%3H2!3*!T@1!.%&I!/2(!I3H%&)=C)!Schizochytrium!);!C3E(*!3*!/2(!S&II3;;3&*!T(H3;3&*!&.!]! 8$*(!566[!K#e4!566[ML! O)>=(!]L!! Uses of NKO™ and maximum levels of DHA and EPA proposed by the applicant! Use group
Maximum level of DHA and EPA
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N*! )HH&%,)*H(! Q3/2! /2(! ')%/3H$=)%! *$/%3/3&*)=! %(R$3%(I(*/;! &.! /2(! '(%;&*;! .&%! Q2&I! /2(! The EFSA Journal K5667M!7[\4!__9_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
'%&,$H/;!)%(!3*/(*,(,! +&&,;! 3*/(*,(,! .&%! $;(! 3*! (*(%C09%(;/%3H/(,! 566!IC^I()=!%('=)H(I(*/! ,3(/;!.&%!Q(3C2/!%(,$H/3&*! ! O2(! I)W3I$I! $;(! =(E(=;! &.! #B1! )*,! T@1! );! '%&'&;(,! >0! /2(! )''=3H)*/! )*,! >);(,! &*! .&&,! H&*;$I'/3&*! ,)/)! &>/)3*(,! .%&I! /2(! U)/3&*)=!T3(/! )*,! U$/%3/3&*! -$%E(0! KUTU-M! '%&C%)I! 3*! /2(! e*3/(,! A3*C,&I! Kp%(C&%0! (/! )=L4! _77]a! eAT14! _77]a! eAT14! 566_a! Y..3H(! .&%! U)/3&*)=! -/)/3;/3H;4!566]M!Q(%(!$;(,!);!)!>);3;!/&!(;/3I)/(!/2(!,)3=0!3*/)F(;!&.!#B1!)*,!T@1!KO)>=(!bML!! O)>=(!bL! Estimated daily intake of EPA and DHA based on the proposed maximum use levels applied to food consumption data obtained in the UK* Population Group S23=,%(*!
Age Group (Years )
% User
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Actual # of Total Users
Mean (mg)
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Percentile (mg)
Percentile (mg)
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Mean (mg)
90
95
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Information from previous human exposure to the NF or its source
-&./C(=! H)';$=(;! H&*/)3*3*C! UAYZ! 2)E(! >((*! )E)3=)>=(! );! ,3(/)%0! ;$''=(I(*/! '%&,$H/;! 3*! U&%/2!1I(%3H)!)*,!1;3)!.&%!;(E(%)=!0()%;L!N*!S)*),)!)*,!/2(!e*3/(,!-/)/(;4!UAYZ!2);!>((*! )E)3=)>=(!.&%!'$%H2);(!;3*H(!YH/&>(%!&.!5665!)*,!3*!8)')*4!A&%()4!-3*C)'&%(!)*,!@&*C!A&*C! ;3*H(!T(H(I>(%!&.!566jL!O2(!%(H&II(*,(,!3*/)F(!&.!UAYZ!3*!U&%/2!1I(%3H)!)*,!1;3)!3;!_!9
The EFSA Journal K5667M!7[\4!_59_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
5! ;&./C(=! H)';$=(;^,)04! ()H2! H&*/)3*3*C! ]66! IC! &.! UAYZL! 1HH&%,3*C! /&! /2(! )''=3H)*/4!! _564666!FC!&.!UAYZ!2);!>((*!;&=,!3*!;&./C(=!H)';$=(!.&%I!>(/Q((*!5665!)*,!566c!K\\f!&.! ;)=(;!3*!U&%/2!1I(%3H)!)*,!_5f!3*!1;3)ML!O23;!H&%%(;'&*,;!/&!5j6!?3==3&*!H)';$=(;!3*!/&/)=!)*,! )*! )E(%)C(! H&*;$I'/3&*! &.! )''%&W3I)/(=0! _[64666! H)';$=(;! '(%! ,)0L! 1HH&%,3*C! /&! /2(! )''=3H)*/4!*&!),E(%;(!(..(H/;!2)E(!>((*!%('&%/(,!&E(%!/2(!I)%F(/3*C!'(%3&,L! XI.
Nutritional information on the NF
UAYZ!3;!3*/(*,(,!);!)!;&$%H(!&.!/2(!/Q&!&I(C)9[!'&=0$*;)/$%)/(,!.)//0!)H3,;!#B1!)*,!T@1! Q23H2!)%(!H&*/)3*(,!3*!/2(!&3=!I)3*=0!3*!'2&;'2&=3'3,;L!#B1!)*,!T@1!)%(!'%(;(*/!3*!/2(!,3(/! .%&I!;(E(%)=!.&&,;!K#+-14!566]>ML!B2&;'2&=3'3,;!);!3*/(C%)=!H&I'&*(*/;!&.!)*3I)=!)*,!'=)*/! H(==! I(I>%)*(;! )%(! )=;&! Q3,(=0! '%(;(*/! 3*! /2(! ,3(/! .%&I! ;&$%H(;4! ;$H2! );! Q2()/! .=&$%4! I3=F4! (CC;4!I()/4!.3;24!;&0>()*!)*,!&/2(%!'=)*/!&3=;L! S&*;3,(%3*C!/2(!=&Q!H&*/(*/!&.!H2&=(;/(%&=!K6L7!9!_L_!C^_66C!.&%!/2(!/2%((!>)/H2(;!=3;/(,!3*!O)>=(! 5M4!/2(!H&*/%3>$/3&*!&.!UAYZ9H&*/)3*3*C!.&&,;!/&!/2(!,3(/)%0!H2&=(;/(%&=!3*/)F(!3;!H&*;3,(%(,! *(C=3C3>=(L! XII.
Microbiological information on the NF
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The EFSA Journal K5667M!7[\4!_[9_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
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Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
S&I'&;3/3&*)=!,)/)!&*!I)d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uphausia superba!K1*/)%/3H!A%3==4!UAYZM!);! )!*&E(=!.&&,!3*C%(,3(*/!3;!;).(!$*,(%!/2(!;'(H3.3(,!H&*,3/3&*;!&.!$;(L!! DOCUMENTATION PROVIDED TO EFSA _L 1''=3H)/3&*! $*,(%! G(C$=)/3&*! K#SM! Um! 5]\^7c! H&*H(%*3*C! *&E(=! .&&,;! )*,! *&E(=! .&&,! 3*C%(,3(*/;! H&*H(%*3*C! X:3'3,! (W/%)H/! .%&I Euphasia suberbaX! );! .&&,! 3*C%(,3(*/4! hA%3==! Y3=i!KU('/$*(!O(H2*&=&C3(;!l!<3&%(;&$%H(;!N*HLM4!+(>%$)%0!566\L! 5L N*3/3)=!);;(;;I(*/!%('&%/!H)%%3(,!&$/!>0!+3*=)*,`! ! 1;(/$F;(*!K#sM!5]\^7c!)%/3F=)*!j!I$F)3*(*!(*;3)%E3&%)'&%//3`!1*/)%F/3;(;/)!F%3==3x0%3x3;(;/)! K#$'2);3)!;$'(%>)M!E)=I3;/(//$!q=d0!KU('/$*(!A%3==!Y3=ZM! ! N*3/3)=! );;(;;I(*/! %('&%/! 3*! H&I'=3)*H(! Q3/2! G(C$=)/3&*! K#SM! U&! 5]\^7c4! 1%/3H=(! j`! Y3=! '%(')%(,!.%&I!)*/)%/3H!F%3==!K#$'2);3)!;$'(%>)M!r!U('/$*(!A%3==!Y3=Z! [L ?(I>(%!-/)/(;w!H&II(*/;! jL G(;'&*;(!/&!?(I>(%!-/)/(;!S&II(*/;!&*!/2(!+3**3;2!1;;(;;I(*/!K>0!/2(!)''=3H)*/M! ! REFERENCES <$*()!G4!#=!+)%%)2!A4!T($/;H2!:4!566jL!#E)=$)/3&*!&.!/2(!(..(H/;!&.!U('/$*(!A%3==!Y3=!&*!/2(! H=3*3H)=!H&$%;(!&.!20'(%=3'3,(I3)L!Altern. Med. Rev. 94!j569j5\L!! <$H2(/! 8! )*,! :)$Q(%0;! G! _77jL! N*/(%'%(/)/3&*! &.! 3*&%C)*3H! )%;(*3H! I(/)>&=3;I! 3*! 2$I)*;! 3*! /2(! =3C2/! &.! &>;(%E)/3&*;! I),(! 3*9E3/%&! )*,! 3*9E3E&! 3*! /2(! %)/L! Appl. Organometal. Chem.! \`_7_9_7bL! T($/;H2! :4! 566cL! #E)=$)/3&*! &.! /2(! (..(H/! &.! U('/$*(! A%3==! Y3=! &*! H2%&*3H! 3*.=)II)/3&*! )*,! )%/2%3/3H!;0I'/&I;L!J. Am. Coll. Toxicol. 5b4![79j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cL!S&II3;;3&*!G(H&II(*,)/3&*!7c^b_\^#S!&.!57!8$=0!_77c! H&*H(%*3*C! /2(! ;H3(*/3.3H! );'(H/;! )*,! /2(! '%(;(*/)/3&*! &.! 3*.&%I)/3&*! *(H(;;)%0! /&! ;$''&%/! )''=3H)/3&*;!.&%!/2(!'=)H3*C!&*!/2(!I)%F(/!&.!*&E(=!.&&,;!)*,!*&E(=!.&&,!3*C%(,3(*/;!)*,!/2(! The EFSA Journal K5667M!7[\4!_]9_b!
Safety of ‘Lipid extract from Euphasia superba' as novel food ingredient
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