Safety of a change of specifications of phytosterols/phytostanols as a novel food pursuant to Regulation (EU)2015/2283

EFSA Jou nal. 2025;23:e9162. e sa.onlinelib a y.wiley.com/jou nal/1831-4732
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h ps://doi.o g/10.2903/j.e sa.2025.9162
SCIENTIFIC OPINION
Sa e y o a change o speci ica ions o phy os e ols/
phy os anols as a no el ood pu suan o Regula ion (EU)
2015/2283
EFSA Panel on Nu i ion, No el Foods and Food Alle gens (NDA) | Dominique Tu ck |
To s en Bohn | Mon aña Cáma a | Jacqueline Cas enmille | S e aan DeHenauw |
Ka en Ildico Hi sch- E ns | Ángeles Jos | Alexand e Maciuk | Inge Mangelsdo |
B eige McNul y | And oniki Naska | K is ina Pen ie a | Al onso Siani | F ank Thies |
Ma ga i a Aguile a- Gómez | F ancesco Cubadda | Thomas F enzel | Ma ina Heinonen |
Monika Neuhäuse - Be hold | Helle Ka ine Knu sen | Mo en Poulsen |
Miguel P ie o Ma adona | Jose Rudol Schla e | Alexand os Siskos | Henk an Lo e en |
Wol gang Gelbmann | Ha y J. McA dle
App o ed: 28 No embe 2024
DOI: 10.2903/j.e sa.2025.9162
Abs ac
Following a eques om he Eu opean Commission, he EFSA Panel on Nu i ion,
No el Foods and Food Alle gens (NDA) was asked o p o ide an opinion on he
sa e y o a change o he speci ica ions o he au ho ised NF ‘phy os e ols/phy o-
s anols’ as a no el ood (NF) pu suan o Regula ion (EU) 2015/2283. This au ho -
ised NF conce ns phy os e ols ex ac ed om plan s and which may be p esen ed
as ee s e ols and s anols o es e i ied wi h ood g ade a y acids. I has o con-
ain less han 81% β- si os e ol, less han 35% β- si os anol, less han 40% camp-
es e ol, less han 15% campes anol, less han 30% s igmas e ol and less han 3%
b assicas e ol. Rega ding he maximum limi o he speci ica ion pa ame e ‘o he
s e ols/s anols’, he applican asks o an inc ease om cu en ly less han 3% o
less han 7% o be e e lec and co e he na u al composi ion and p opo ions
o sun lowe - based phy os e ols/phy os anols, no ing ha he exis ing speci ica-
ions ha e been es ablished la gely based on he NF when sou ced om soy. No
e idence was ound om he li e a u e o he geno oxici y, subch onic oxici y,
ch onic oxici y and ca cinogenici y, and ep oduc i e oxici y o ou phy os e ols
which ha e been iden i ied by he applican in he NF when p oduced om sun-
lowe oil. These ou phy os e ols, albei a lowe concen a ions, a e also ound
in he NF i p oduced om soy. The Panel also no es he his o y o mul iple sa e y
assessmen s o phy os e ols pe o med by Membe S a es and EFSA, in addi ion o
he g oup ADI es ablished by JECFA. The Panel also conside s ha an inc ease om
less han 3 o less han 7% o he maximum speci ica ion limi o ‘o he phy os-
e ols’ is o no ele ance ega ding nu i ional conside a ions. The Panel concludes
ha he NF is sa e unde he p oposed change o he speci ica ions.
KEYWORDS
del a- 7- s igmas enol, no el oods, phy os anol es e s, phy os anols, phy os e ol es e s,
phy os e ols, sun lowe oil
The decla a ions o in e es o all scien i ic
expe s ac i e in EFSA's wo k a e a ailable a
h ps:// open. e sa. eu opa. eu/ expe s
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o iginal wo k is p ope ly ci ed and no modi ica ions o adap a ions a e made.
© 2025 Eu opean Food Sa e y Au ho i y. EFSA Jou nal published by Wiley-VCH GmbH on behal o Eu opean Food Sa e y Au ho i y.
Co espondence: ni @e sa.eu opa.eu
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CONTENTS
Abs ac ................................................................................................................................................................................................................................1
1. In oduc ion ..............................................................................................................................................................................................................3
1.1. Backg ound and Te ms o Re e ence as p o ided by he eques o .........................................................................................3
1.2. Addi ional in o ma ion ..............................................................................................................................................................................3
2. Da a and Me hodologies ......................................................................................................................................................................................4
2.1. Da a ...................................................................................................................................................................................................................4
2.2. Me hodologies..............................................................................................................................................................................................4
3. Assessmen ................................................................................................................................................................................................................4
3.1. In oduc ion ...................................................................................................................................................................................................4
3.2. P oduc ion p ocess .....................................................................................................................................................................................5
3.3. Composi ional da a .....................................................................................................................................................................................5
3.4. Speci ica ions ................................................................................................................................................................................................7
3.5. The sa e y o he ac ion ‘o he phy os e ols’ ..................................................................................................................................7
4. Discussion...................................................................................................................................................................................................................8
5. Conclusions ................................................................................................................................................................................................................8
5.1. P o ec ion o P op ie a y da a in acco dance wi h A icle 26 o Regula ion (EU) 2015/2283 ...........................................8
6. S eps aken by EFSA ................................................................................................................................................................................................8
Abb e ia ions ....................................................................................................................................................................................................................8
Reques o ............................................................................................................................................................................................................................9
Ques ion numbe .............................................................................................................................................................................................................9
Panel membe s .................................................................................................................................................................................................................9
Re e ences...........................................................................................................................................................................................................................9
Appendix A ......................................................................................................................................................................................................................10
Annex A .............................................................................................................................................................................................................................11
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A NOVEL FOOD PURSUANT TO REGULATION (EU) 2015/2283
1 | INTRODUCTION
1.1 | Backg ound and Te ms o Re e ence as p o ided by he eques o
On 29 June 2023, he company Ad anced O ganic Ma e ials SA. submi ed an applica ion o he Eu opean Commission in
acco dance wi h A icle 10 o Regula ion (EU) 2015/2283 o a change o he speci ica ions o he au ho ised no el ood (NF)
‘phy os e ols/phy os anols’.
The applican has eques ed da a p o ec ion unde A icle 26 o Regula ion (EU) 2015/2283 o da a in suppo o his
eques .
In acco dance wi h A icle 10(3) o Regula ion (EU) 2015/2283, he Eu opean Commission asks he Eu opean Food Sa e y
Au ho i y o p o ide a scien i ic opinion on he sa e y o a change o he speci ica ions o he au ho ised NF ‘phy os e ols/
phy os anols’.
In his opinion on a change o he speci ica ions o he au ho ised NF ‘phy os e ols/phy os anols’, he Eu opean Food
Sa e y Au ho i y should also documen whe he and o wha ex en he equi emen s o A icle 26(2)(c) o Regula ion (EU)
2015/2283 a e ul illed ega ding he da a o which he applican is eques ing da a p o ec ion.
1.2 | Addi ional in o ma ion
In 2000, he Scien i ic Commi ee on Food (SCF) assessed he sa e y o phy os e ol es e s (PSE) in yellow a sp eads unde
Regula ion (EU) No 258/97 (SCF,2000). Tha assessmen conce ned phy os e ols isola ed om con en ional edible oils
(soya, maize, sun lowe , apeseed) es e i ied wi h a y acids om sun lowe oil. The SCF concluded ha PSE in yellow a
sp eads a a maximum le el co esponding o 8% ee PS a e sa e o human use. Consequen ly, in 2000, he Eu opean
Commission adop ed he Decision 2000/500/EC au ho ising he placing on he ma ke o ‘yellow a sp eads wi h added
PSE’ as a no el ood o no el ood ing edien unde Regula ion (EC) No 258/97.
In 2002, he SCF was asked o assess po en ial long- e m e ec s o he in ake o ele a ed le els o PS om mul iple di-
e a y sou ces, wi h pa icula a en ion o he e ec s on β- ca o ene (SCF,2002). Conside ing ha in akes o PS abo e 3 g pe
pe son pe day do no p o ide addi ional bene i s on blood choles e ol and ha he consequences o a pe sis en dec ease
in β- ca o ene blood concen a ions on human heal h a e la gely unknown, he SCF deemed i p uden o a oid PS in akes
exceeding 3 g/day.
In 2004, an ex ension o his ma ke ing au ho isa ion was au ho ised o he uses o PSE in milk- and yoghu ype-
p oduc s by Commission Decision 2004/335/EC.1 Also in 2004, Commission Regula ion (EC) No 608/20042 conce ning he
labelling o oods and ood ing edien s wi h added ee phy os e ols, phy os e ol es e s, phy os anols and/o phy os anol
es e s, laid down labelling equi emen s and limi ing he consump ion o added PS o a maximum o 3 g pe pe son pe
day.
In 2005, he EFSA NDA Panel published hei opinion on ce ain aspec s o se um le els o phy os e ols (EFSA NDA
Panel,2005); in he ollowing yea s, on he sa e y o ice d inks wi h added phy os e ols (EFSA NDA Panel,2006) and in 2007
on he sa e y o ui juices and nec a s wi h added phy os e ols (EFSA NDA Panel,2007a). In ano he opinion om 2007, he
NDA Panel assessed he p oduc ion p ocess o phy os e ols when sou ced om soybean (EFSA NDA Panel,2007b).
A hei 69 h mee ing, JECFA no ed ha phy os e ol and phy os anol es e s and mix u es o phy os e ols and phy os a-
nols gene ally show simila e ec p o iles and es ablished a g oup accep able daily in ake (ADI) o 0 o 40 mg PS/kg body
weigh o ee phy os e ols and – s anols and hei es e s. This co esponds o a daily in ake o 2.8 g PS/day o a 70 kg
indi idual (JECFA, 2009). This conclusion was based on an o e all NOAEL de i ed om se e al subch onic (90 days) s udies,
suppo ed by s udies on ep oduc i e oxici y. The JECFA Panel also no ed ha he e is no e idence o geno oxici y o
phy os e ols o phy os anols and hei es e s and no indica ion o po en ial o ca cinogenici y.
In 2013, he applican submi ed a no i ica ion pu suan o A icle 5 (‘subs an ial equi alence’) o Regula ion (EC) No
258/973 o hei phy os e ols and phy os e ol es e s de i ed om edible oils, mainly om soybean, suppo ed by a s a emen
o he compe en au ho i y o Finland (E i a,2013; unpublished) o he Eu opean Commission. F ee phy os e ols, − s anols,
and hei es e s ha e been mul iple imes subjec o such no i ica ions (Eu opean Commission, 20184).
In 2017, exis ing applican - speci ic au ho isa ions g an ed unde Regula ion (EU) 1997/258 o ee and es e i ied phy os-
e ols and s anols ex ac ed om plan s we e ans e ed in o he EU Union lis o NF (Commission Implemen ing
Regula ion (EU) 2017/2470)5 and a e now co e ed he e by he en y ‘phy os e ols/phy os anols’. The ma ke ing au ho isa-
ion lays down labelling equi emen s in acco dance wi h Annex III o Regula ion (EU) No 1169/2011,6 including he need o
indica e (1) he a ge popula ion, i.e. ‘people who wan o lowe hei choles e ol le els’, (2) ha pa ien s on choles e ol
1h ps:// eu - lex. eu opa. eu/ legal- con e n / EN/ TXT/ HTML/? u i= CELEX: 32004 D0335 .
2h ps:// eu - lex. eu opa. eu/ LexU iSe / LexU iSe . do? u i= OJ:L: 2004: 097: 0044: 0045: EN: PDF#: ~: ex = I % 20se s% 20ou % 20spe ci ic% 20lab ellin g,lowe % 20 he i % 20blo
od% 20cho les e ol% 20le els. & ex = This% 20Reg ula i on% 20sha ll% 20app ly% 20 o,phy o s ano ls% 20o % 20phy os% 2D% 20 an ol% 20es e s.
3h ps:// eu - lex. eu opa. eu/ legal- con e n / EN/ TXT/ HTML/? u i= CELEX: 31997 R0258 .
4h ps:// ood. ec. eu opa. eu/ sys em/ iles/ 2018- 06/ no el- ood_ no i ica i ons_ en. pd .
5h ps:// eu - lex. eu opa. eu/ legal- con e n / EN/ TXT/ HTML/? u i= CELEX: 32017 R2470 .
6h ps:// eu - lex. eu opa. eu/ legal- con e n / EN/ TXT/ HTML/? u i= CELEX: 32011 R1169# n 10-L_ 20113 04EN. 01001 801- E0010 .
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lowe ing medica ion should only consume he p oduc unde medical supe ision, (3) ha he p oduc may no be nu i-
ionally app op ia e o p egnan and b eas eeding women and child en unde he age o 5 yea s, (4) ha he p oduc
should be used as pa o a heal hy die , including egula consump ion o ui and ege ables o help main ain ca o enoid
le els and (5) o a oid consump ion o mo e han 3 g pe day.
The EFSA NDA Panel's mos ecen sa e y assessmen o phy os e ols conce ned an ex ension o use o phy os e ol es-
e s added o ege able a sp eads and o liquid ege able a - based emulsions o cooking and baking pu poses, which
could no es ablish he sa e y o hese pu poses (EFSA NDA Panel,2020).
2 | DATA AND METHODOLOGIES
2.1 | Da a
The sa e y assessmen o his NF is based on da a supplied in he applica ion and addi ional da a iden i ied by he Panel.
Adminis a i e and scien i ic equi emen s o NF applica ions e e ed o in A icle 10 o Regula ion (EU) 2015/2283 a e
lis ed in Commission Implemen ing Regula ion (EU) 2017/2469.7
A common and s uc u ed o ma on he p esen a ion o NF applica ions is desc ibed in he EFSA guidance on he
p epa a ion and p esen a ion o a NF applica ion (EFSA NDA Panel,2021). As indica ed in his guidance, i is he du y o he
applican o p o ide all a ailable (p op ie a y, con iden ial and published) scien i ic da a, (including bo h da a in a ou
and no in a ou ) ha a e pe inen o he sa e y o he NF.
The applican has submi ed a con iden ial and a non- con iden ial e sion o a dossie ollowing he EFSA guidelines
on he p epa a ion and p esen a ion o a NF applica ion (EFSA NDA Panel,2021) and he adminis a i e guidance o he
p epa a ion o applica ions on no el oods pu suan o A icle 10 o Regula ion (EU) 2015/2283 (EFSA, 2024).
In acco dance wi h A . 38 o Regula ion (EC) No 178/20028 and aking in o accoun he p o ec ion o con iden ial in o -
ma ion and o pe sonal da a in acco dance wi h A icles 39 o 39e o he same Regula ion, and he Decision o EFSA's
Execu i e Di ec o laying down p ac ical a angemen s conce ning anspa ency and con iden iali y,9 he non- con iden ial
e sion o he dossie has been published on Open.EFSA.10
Acco ding o A . 32c(2) o Regula ion (EC) No 178/2002 and o he Decision o EFSA's Execu i e Di ec o laying down he
p ac ical a angemen s on p e- submission phase and public consul a ions,2 EFSA ca ied ou a public consul a ion on he
non- con iden ial e sion o he echnical dossie om 1/8 o 22/8/2024. The commen ecei ed has been ca e ully e alu-
a ed and conside ed du ing he cu en assessmen (Annex A).
This NF applica ion includes a eques o p o ec ion o p op ie a y da a in acco dance wi h A icle 26 o Regula ion (EU)
2015/2283. The da a eques ed by he applican o be p o ec ed a e lis ed in Appendix A.
2.2 | Me hodologies
The assessmen ollows he me hodology se ou in he EFSA guidance on NF applica ions (EFSA NDA Panel,2021) and he
p inciples desc ibed in he ele an exis ing guidance documen s om he EFSA Scien i ic Commi ee. The legal p o isions
o he assessmen a e laid down in A icle 11 o Regula ion (EU) 2015/2283 and in A icle 7 o Commission Implemen ing
Regula ion (EU) 2017/2469.
This assessmen conce ns only he isks ha migh be associa ed wi h consump ion o he NF unde he p oposed con-
di ions o use and is no an assessmen o he e icacy o he NF wi h ega ds o any claimed bene i .
3 | ASSESSMENT
3.1 | In oduc ion
The NF ‘phy os e ols/phy os anols’ alls unde he ca ego y de ined in a icle 3.2 (a) (i ) o Regula ion (EU) 2015/2283, i.e.
ood consis ing o , isola ed om o p oduced om plan s o hei pa s.
Acco ding o Table1 o he Annex o he EU Union lis ,11 he NF subjec o he applica ion, is phy os e ols and phy os a-
nols ex ac ed om plan s and may be p esen ed as ee s e ols and s anols o es e i ied wi h ood g ade a y acids. I shall
7Commission Implemen ing Regula ion (EU) 2017/2469 o 20 Decembe 2017 laying down adminis a i e and scien i ic equi emen s o applica ions e e ed o in A icle
10 o Regula ion (EU) 2015/2283 o he Eu opean Pa liamen and o he Council on no el oods. OJ L 351, 30.12.2017, pp. 64–71.
8Regula ion (EC) No 178/2002 o he Eu opean Pa liamen and o he Council o 28 Janua y 2002 laying down he gene al p inciples and equi emen s o ood law,
es ablishing he Eu opean Food Sa e y Au ho i y and laying down p ocedu es in ma e s o ood sa e y. OJ L 31, 1.2.2002, p. 1–48.
9Decision a ailable a : h ps://www.e sa.eu opa.eu/en/co po a e- pubs/ anspa ency- egula ion- p ac ical- a angemen s.
10The non- con iden ial e sion o he dossie has been published on Open.EFSA and is a ailable a he ollowing link: h ps:// open. e sa. eu opa. eu/ consu l a i ons/ a0cTk
00000 4 WHX IA2? sea ch= EFSA-Q- 2023- 00497 .
11h ps:// eu - lex. eu opa. eu/ legal- con e n / EN/ TXT/ HTML/? u i= CELEX: 32017 R2470 .
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con ain less han 81% β- si os e ol, less han 35% β- si os anol, less han 40% campes e ol, less han 15% campes anol, less
han 30% s igmas e ol, less han 3% b assicas e ol and less han 3% o he s e ols/s anols.
The applican no es ha he i s sa e y assessmen o he NF by he SCF in 2000, which led o he ma ke ing au ho isa-
ion o he NF, co e ed ‘con en ional edible oils (soya, maize, sun lowe , apeseed)’. The applican also no ed ha he main
sou ce o phy os e ols o mos o he manu ac u e s, including he applican himsel , so a had been soybean. Acco ding
o he applican , he phy os e ol ac ions in sun lowe oil is howe e sligh ly di e en compa ed wi h he phy os e ols/
phy os anols de ined in he EU Union lis o NF (Commission Implemen ing Regula ion (EU) 2017/2470).
The applican he e o e asks o inc ease he maximum limi o he speci ica ion pa ame e ‘o he s e ols/s anols’ om
less han 3% o less han 7% o be e e lec and co e he na u al composi ion and p opo ions o sun lowe - based
phy os e ols/phy os anols.
The applica ion is suppo ed by da a on wo phy os e ol p oduc s p oduced by he applican om e ined sun lowe oil,
one conce ns ee phy os e ols and he o he one phy os e ol es e s.
3.2 | P oduc ion p ocess
Acco ding o he applican , he phy os e ols a e ex ac ed om edible sun lowe oil p oduced om sun lowe c ops g own
and ha es ed acco ding o no mal ag icul u al p ac ices. Fo hei es e p oduc , a y acids om soybean, apeseed o
sun lowe a e used.
Acco ding o he in o ma ion p o ided by he applican , hei phy os e ol ing edien s, one composed la gely o ee
phy os e ols, he o he one o phy os e ol es e s, a e p oduced in line wi h Good Manu ac u ing P ac ice (GMP) and Haza d
Analysis C i ical Con ol Poin s (HACCP) p inciples.
3.3 | Composi ional da a
The applican p o ided composi ional analy ical da a on i e ba ches each o hei ee phy os e ol (Table1) and phy os-
e ol es e (Table2) ing edien s de i ed om sun lowe .
TABLE 1 Ba ch o ba ch analysis o he NF composed la gely by ee phy os e ols p oduced om sun lowe .
Pa ame e (g/100 g NF) Ba ch 1 Ba ch 2 Ba ch 3 Ba ch 4 Ba ch 5
To al plan s e ols + s anols 92.76 92.15 94.31 94.16 94.01
β- Si os e ol 57.58 56.45 58.14 58.10 58.53
Campes e ol 11.56 11.88 11.99 11.97 12.00
Campes anol 0.17 0.20 0.15 0.15 0.15
S igmas e ol 14.64 14.70 15.30 15.28 14.79
B assicas e ol 0.97 1.02 1.12 1.11 1.04
β- Si os anol + del a- 5- a enas e ol 1.80 1.78 1.74 1.75 1.76
β- Si os anola1.73 1.69 1.74 1.74 1.76
Del a- 5- a enas e olb0.07 0.09 0.00 0.01 0.00
Del a- 7- a enas e ol 0.45 0.45 0.43 0.43 0.43
Del a- 7- s igmas enol 3.16 3.25 3.06 3.05 2.94
Del a- 5,24- s igmas adienol 0.63 0.61 0.65 0.59 0.61
Uniden i ied s e ols 1.81 1.81 1.74 1.75 1.75
Sum o o he s e ols/s anolsc6.12 6.21 5.88 5.83 5.73
aCalcula ed by using he o mula o 0.03 × β- si os e ol con en .
bCalcula ed by sub ac ing he β- si os anol con en om β- si os anol + del a- 5- a enas e ol con en .
cSum o del a- 5- a enas e ol, del a- 7- a enas e ol, del a- 7- s igmas enol, del a- 5,24- s igmas adienol and uniden i ied s e ols.
TABLE 2 Ba ch o ba ch analysis o he NF composed la gely by phy os e ol es e s.
Pa ame e (g/100 g NF) Ba ch 1 Ba ch 2 Ba ch 3 Ba ch 4 Ba ch 5
To al plan s e ols + s anols 58.51 58.47 57.83 58.42 58.12
β- Si os e ol 36.36 36.48 36.35 35.60 35.80
Campes e ol 7.27 7.05 7.03 7.67 7.34
Campes anol 0.05 0.05 0.06 0.12 0.09
S igmas e ol 10.09 9.62 9.29 9.51 9.54
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The phy os e ols/phy os anols o bo h p oduc s we e analysed by acc edi ed labo a o ies wi h alida ed gas ch oma-
og aphy– lame ionisa ion de ec ion (GC–FID) based me hods in compliance wi h he equi emen (i.e. GC–FID o equi a-
len me hod) speci ied in he EU Union lis .
The applican no es ha he composi ion o all es ed ba ches p esen ed in Tables1, 2 complies wi h he speci ica ion
limi s o he NF as laid down by he EU Union lis , excep o he pa ame e ‘O he s e ols/s anols’ which exceeds he max-
imum pe mi ed limi o ‘below 3 %’.
Acco ding o Tables1, 2, ou phy os e ols we e iden i ied ep esen ing a leas 2/3 o he ac ion ‘o he phy os e ols’.
One o he iden i ied phy os e ols, del a- 7- s igmas enol, ep esen s abou hal o he ac ion ‘o he phy os e ols’ in bo h
p oduc s, while he o he iden i ied phy os e ols, i.e. del a- 5- a enas e ol, del a- 7- a enas e ol, del a- 5,24- s igmas adienol
ep esen abou 10% o less o ha ac ion o less han 0.7% o he NF.
Acco ding o he applican , he exceedance o ‘o he phy os e ols’ is due o he sligh ly di e en phy os e ol p o ile, i.e.
highe p opo ion o del a- 7- a enas e ol, del a- 7- s igmas enol and del a- 5,24- s igmas adienol o sun lowe oil compa ed
o soybean oil o which he cu en speci ica ion limi s ha e been mainly es ablished. To suppo his claim, he applican
p o ided a compa ison o he phy os e ol p o ile o he NF when p oduced om soybean oil and om sun lowe oil ( wo
ba ches o each ype; Table3).
The Panel no es ha he main di e ences be ween he NFs o he applican when p oduced om soybeans o sun-
lowe s conce n he p opo ion o ‘o he phy os e ols’, which appea s o be abou double when p oduced om sun lowe
and wi h ega ds o he ou iden i ied phy os e ols comp ised by he ac ion o ‘o he phy os e ols’, he main di e ences
we e ound o del a- 7- s igmas enol (abou i e imes highe in sun lowe - de i ed phy os e ols) and del a- 7- a enas e ol
TABLE 3 Compa ison o he s e ol composi ion o he NF ( ee phy os e ols/s anols) when sou ced om
soybean oil and sun lowe oil, bo h manu ac u ed by he applican .
Pa ame e (g/100 g NF)
NF sou ced om soybean NF sou ced om sun lowe
Ba ch 1 Ba ch 2 Ba ch 1 Ba ch 2
β- Si os e ol 43.49 42.20 55.96 53.30
S igmas e ol 24.89 26.50 16.28 16.14
Campes e ol 21.51 22.40 11.68 13.53
B assicas e ol 0.20 0.21 0.22 0.23
Campes anol 0.34 0.39 0.20 0.25
β- Si os anol + del a- 5- a enas e ol 1.68 1.67 1.73 1.80
β- Si os anola1.30 1.27 1.68 1.60
Del a- 5- a enas e olb0.38 0.40 0.05 0.20
Del a- 7- a enas e ol 0.17 0.19 0.45 0.43
Del a- 7- s igmas enol 0.64 0.68 3.19 3.16
Del a- 5,24- s igmas adienol 0.45 0.35 0.54 0.59
Uniden i ied s e ols 1.40 1.26 1.74 1.86
To al plan s e ols + s anols 94.76 95.84 91.97 91.28
Sum o o he s e ols/s anolsc3.04 2.88 5.97 6.24
aCalcula ed by using he o mula o 0.03 x β- si os e ol con en .
bCalcula ed by sub ac ing he β- si os anol con en om β- si os anol + del a- 5- a enas e ol con en .
cSum o del a- 5- a enas e ol, del a- 7- a enas e ol, del a- 7- s igmas enol, del a- 5,24- s igmas adienol and uniden i ied s e ols.
Pa ame e (g/100 g NF) Ba ch 1 Ba ch 2 Ba ch 3 Ba ch 4 Ba ch 5
B assicas e ol 0.33 0.28 0.35 0.18 0.22
β- Si os anol + del a- 5- a enas e ol 1.17 1.15 1.09 1.11 1.09
β- Si os anola1.09 1.09 1.09 1.07 1.07
Del a- 5- a enas e olb0.08 0.06 0.00 0.04 0.02
Del a- 7- a enas e ol 0.22 0.28 0.26 0.28 0.27
Del a- 7- s igmas enol 1.48 2.06 1.90 2.24 2.13
Del a- 5,24- s igmas adienol 0.46 0.37 0.43 0.36 0.36
Uniden i ied s e ols 1.09 1.13 1.09 1.36 1.26
Sum o o he s e ols/s anolsc3.33 3.90 3.68 4.28 4.04
aCalcula ed by using he o mula o 0.03 x β- si os e ol con en .
bCalcula ed by sub ac ing he β- si os anol con en om β- si os anol + del a- 5- a enas e ol con en .
cSum o del a- 5- a enas e ol, del a- 7- a enas e ol, del a- 7- s igmas enol, del a- 5,24- s igmas adienol and uniden i ied s e ols.
TABLE 2 (Con inued)
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(abou wo o h ee imes highe in sun lowe - de i ed phy os e ols). Howe e , he Panel conside s ha quan i a i ely, he
di e ences obse ed be ween soybean and sun lowe NFs o hese compounds a e also small.
In addi ion, aiming o p o ide addi ional e idence ha he ac ion o ‘o he phy os e ols’ di e s sligh ly be ween phy-
os e ols sou ced om sun lowe as compa ed o o he sou ces, in pa icula ly soya, he applican p o ided wo published
e e ences om he li e a u e (Phillips e al.,2005; Zhang e al.,2006). Zhang e al.(2006) no ed abou i e imes highe
amoun s o del a- 7- phy os e ols in sun lowe oil as compa ed o soya oil. Phillips e al.(2005) epo ed amoun s o o al
phy os e ols in h ee di e en sun lowe seed ke nels (265–289 mg/100 g) and o del a- 7- s igmas enol (17.5–22 g/100 g),
which co esponds o app oxima ely 7% o phy os e ols ep esen ed by del a- 7- s igmas enol in hese samples. In addi ion,
EFSA ound addi ional e e ences which epo ed a p opo ion o abou 8–10% o del a- 7- s igmas enol o he o al phy-
os e ol ac ion in wo B asilian sun lowe seed samples (Rosa e al., 2009). Choong e al.(1999), who analysed he ee and
o al phy os e ol composi ion o a ious animal and ege able a s and oils, epo ed 213 μg (3.2%) del a- 7- s igmas enol
among 6587 μg o al phy os e ols o hei sun lowe oil sample, simila o he p opo ion o ha phy os e ol in he NF o
he applican when sou ced om sun lowe .
In addi ion o he analy ical da a on he phy os e ol and phy os anol composi ion, mic obiological analyses ( o al ae o-
bic bac e ia, yeas and moulds, coli o ms, E. coli, Salmonella and S aphylococcus) and on con aminan s (hea y me als, PAHs,
dioxins and u ans, polychlo ina ed biphenyls (PCBs), a la oxins, sulpha ed ash and pes icide esidues) a e p o ided o
demons a e he pu i y o he applican 's p oduc s. Also, analy ical da a on he sol en esidues we e p o ided.
The Panel conside s ha he analy ical es ing o bo h applican 's p oduc s indica es ha hey can be ep oducibly
manu ac u ed. The ba ches o bo h p oduc s show a consis en phy os e ol/phy os anol p o ile wi h small di e ences
be ween he ba ches.
3.4 | Speci ica ions
The applican is eques ing a change o he speci ica ions o he NF phy os e ols/phy os anols in Commission Implemen ing
Regula ion (EU) 2017/2470 (‘EU Union lis ’). The eques conce ns o inc ease he speci ica ion pa ame e o ‘o he s e ols/
s anols’ om less han 3 o less han 7% as indica ed below in Table4. The unde lying eason o his eques is o be e e-
lec and co e he na u al composi ion and p opo ions o phy os e ols/phy os anols i sou ced om sun lowe oil, which
is al eady a pe mi ed sou ce o he NF.
3.5 | The sa e y o he ac ion ‘o he phy os e ols’
No new da a ha e been gene a ed by he applican ega ding abso p ion, diges ion, me abolism and exc e ion, nu i ional
in o ma ion, oxici y and alle genici y. Because he bigges di e ences be ween he phy os e ols sou ced om soybean
and sun lowe conce ned del a- 7- s igmas enol and del a- 7- a enas e ol, he applican conduc ed an ex ensi e li e a u e
sea ch o oxici y s udies a ge ing hese wo compounds. The li e a u e sea ch was designed o de ec in i o and in i o
oxici y s udies in es iga ing he sa e y o phy os e ol p epa a ions con aining a simila p opo ion o del a- 7- s igmas enol
and del a- 7- a enas e ol as he sun lowe - based phy os e ol p oduced by he applican . In addi ion, in i o and in i o
oxici y s udies especially on del a- 7- s igmas enol and del a- 7- a enas e ol indi idually, we e sea ched o . No new in i o
o in i o da a ela ed o geno oxici y, subch onic oxici y, ch onic oxici y and ca cinogenici y, and ep oduc i e oxic-
i y we e iden i ied. Ne e heless, he applican abs ained om pe o ming new oxicological s udies, conside ing ha
sun lowe oil is no only an al eady au ho ised sou ce, bu has also an ex ensi e his o y o human consump ion, ha hei
p oduc ion p ocess (albei using mainly soy as a sou ce) has been al eady assessed by he Finnish compe en au ho i y in
2013, and ha ‘phy os e ols/phy os anols’ om di e en plan sou ces ha e been al eady assessed mul iple imes by EFSA
and by Membe S a es. The applican also e e s o JECFA who has es ablished a g oup ADI o ee phy os e ols, − s anols
and hei es e s. The applican u he conside ed ha he iden i ied ou phy os e ols which comp ise abou 2/3 o he
TABLE 4 Speci ica ions o he NF.
Desc ip ion as de ined by Commission Implemen ing Regula ion (EU) 2017/2470: Phy os e ols and phy os anols a e s e ols and s anols ha a e
ex ac ed om plan s and may be p esen ed as ee s e ols and s anols o es e i ied wi h ood g ade a y acids.
Pa ame e
Limi s as cu en ly au ho ised unde Commission Implemen ing
Regula ion (EU) 2017/2470 (‘EU Union lis ’)
Change as p oposed by he
applican
β- si os e ol < 81% –
β- si os anol < 35% –
Campes e ol < 40% –
Campes anol < 15% –
S igmas e ol < 30% –
B assicas e ol < 3% –
O he s e ols/s anols < 3% < 7%
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ac ion o ‘o he phy os e ols’ a e also, albei in lowe quan i ies, p esen in phy os e ol p epa a ions when p oduced om
soy. The applican also conside ed ha he abili y o oxici y es s o de ec o disc imina e e ec s o such a small concen-
a ion di e ence in he ‘o he s e ol ac ion’ is mos likely o be insu icien .
4 | DISCUSSION
The NF, which is he subjec o he applica ion, conce ns he au ho ised NF phy os e ols and – s anols ex ac ed om
plan s and which may be p esen ed as ee s e ols and s anols o es e i ied wi h ood g ade a y acids. The applican
has eques ed o inc ease he maximum speci ica ion limi o ‘o he phy os e ols’ om < 3% o < 7%. Acco ding o he
applican , and suppo ed by published e e ences, such a highe maximum speci ica ion limi would be e e lec he
na u al composi ion and p opo ions o sun lowe - based phy os e ols/phy os anols, no ing ha he exis ing speci ica ions
ha e been es ablished la gely on he basis o he NF when sou ced om soy. No e idence was iden i ied o he geno oxici y,
subch onic oxici y, ch onic oxici y and ca cinogenici y, and ep oduc i e oxici y o ou phy os e ols (del a- 5- a enas e ol,
del a- 7- a enas e ol, del a- 7- s igmas enol, del a- 5,24- s igmas adienol) which ha e been iden i ied by he applican in he
NF when p oduced om sun lowe oil. These ou phy os e ols, albei a lowe concen a ions, a e also ound in he NF i
p oduced om soy. The applican p o ided a gumen s why he conside ed ha he small di e ences o he ac ion ‘o he
phy os e ols’ o he NF when sou ced om soy- o sun lowe oil, do no wa an o pe o m new oxicological s udies.
Conside ing hese a gumen s and no ing he his o y o mul iple sa e y assessmen s o phy os e ols pe o med by Membe
S a es and EFSA, in addi ion o he g oup ADI es ablished by JECFA, he Panel concu s wi h ha iew. The Panel also
conside s ha an inc ease om < 3% o < 7% o he maximum speci ica ion limi o ‘o he phy os e ols’ is o no ele ance
ega ding nu i ional conside a ions.
5 | CONCLUSIONS
The Panel concludes ha he NF is sa e unde he p oposed change o he speci ica ions.
5.1 | P o ec ion o P op ie a y da a in acco dance wi h A icle 26 o Regula ion (EU)
2015/2283
The Panel could no ha e eached he conclusion on he sa e y o he NF unde he p oposed condi ions o use wi hou
he da a claimed as p op ie a y by he applican (each i e ba ches o he applican 's ee phy os e ol p oduc and hei
phy os e ol es e p oduc manu ac u ed om sun lowe oil; Annexes 11a and 12a) and alida ion da a o hei in- house
me hod o he de e mina ion o phy os e ol con en using gas ch oma og aphy (Annex 17e).
6 | STEPS TAKEN BY EFSA
1. On 04/01/24, EFSA ecei ed a le e om he Eu opean Commission wi h he eques o a scien i ic opinion
on he sa e y o a change o speci ica ions o he au ho ised no el ood NF ‘phy os e ols/phy os anols’ Re .
A es(2024)39029–04/01/2024.
2. On 04/01/24, a alid applica ion on a change o speci ica ions o phy os e ols/phy os anols, which was submi ed by
Ad anced O ganic Ma e ials SA., was made a ailable o EFSA by he Eu opean Commission h ough he Commission
e- submission po al (NF 2022–12,290) and he scien i ic e alua ion p ocedu e was ini ia ed.
3. Du ing i s mee ing on 28 No embe 2024 he NDA Panel, ha ing e alua ed he da a, adop ed a scien i ic opinion on he
sa e y o a change o speci ica ions and phy os e ols/phy os anols as a NF pu suan o Regula ion (EU) 2015/2283.
ABBREVIATIONS
ADI accep able daily in ake
FAO Food and Ag icul u e O ganisa ion
GC- FID Gas ch oma og aphy lame ionisa ion de ec o
GMP Good Manu ac u ing P ac ice
HACCP Haza d Analysis C i ical Con ol Poin s
JECFA Join FAO/WHO Expe Commi ee on Food Addi i es
NDA EFSA Panel on Nu i ion, No el Foods and Food Alle gens
NOAEL no obse ed ad e se e ec le el
NF no el ood
PAHs polycyclic a oma ic hyd oca bons
PCBs polychlo ina ed biphenyls
PS phy os e ols
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PSE phy os e ol es e s
SCF Scien i ic Commi ee on Food
WHO Wo ld Heal h O ganiza ion
REQUESTOR
Eu opean Commission
QUESTION NUMBER
EFSA- Q- 2023- 00497
PANEL MEMBERS
Dominique Tu ck, To s en Bohn, Mon aña Cáma a, Jacqueline Cas enmille , S e aan de Henauw, Ka en- Ildico Hi sch- E ns ,
Ángeles Jos, Alexand e Maciuk, Inge Mangelsdo , B eige McNul y, And oniki Naska, K is ina Pen ie a, Al onso Siani, and
F ank Thies.
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