TY - JOUR
T1 - Follow-up of the re-evaluation of quillaia extract (E 999) as a food additive and safety of the proposed extension of uses
AU - EFSA Panel on Food Additives and Flavourings (FAF)
AU - Younes, Maged
AU - Aquilina, Gabriele
AU - Castle, Laurence
AU - Degen, Gisela
AU - Engel, Karl Heinz
AU - Fowler, Paul
AU - Frutos Fernandez, Maria Jose
AU - Gundert-Remy, Ursula
AU - Gürtler, Rainer
AU - Husøy, Trine
AU - Manco, Melania
AU - Mennes, Wim
AU - Moldeus, Peter
AU - Passamonti, Sabina
AU - Shah, Romina
AU - Waalkens-Berendsen, Ine
AU - Wright, Matthew
AU - Cheyns, Karlien
AU - Mirat, Manuela
AU - Rincon, Ana Maria
AU - Tard, Alexandra
AU - Zakidou, Panagiota
AU - Fürst, Peter
N1 - Publisher Copyright:
© 2024 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
PY - 2024/2
Y1 - 2024/2
N2 - Quillaia extract (E 999) was re-evaluated in 2019 by the EFSA Panel on Food Additives and Flavourings (FAF). EFSA derived an acceptable daily intake (ADI) of 3 mg saponins/kg bw per day for E 999. Following a European Commission call for data to submit data to fill the data gaps, the present follow-up opinion assesses data provided by interested business operators (IBOs) to support an amendment of the EU specifications for E 999. Additionally, this opinion deals with the assessment of the proposed extension of use for E 999 in food supplements supplied in a solid and liquid form, excluding food supplements for infants and young children and, as a carrier in botanical nutrients. The Panel concluded that the proposed extension of use, if authorised, could result in an exceedance of the ADI at the maximum of the ranges of the mean for children, adolescents and the elderly, and for all populations at the 95th percentile. An additional proposed extension of use for E 999 to be used as a carrier for glazing agents on entire fresh fruits and vegetables has been received. Since no information on the proposed use levels of E 999 on a saponins content basis has been provided by this applicant, the Panel was not able to evaluate the safety of this extension of use. Considering the technical data submitted, the Panel recommended some modifications of the existing EU specifications for E 999, mainly to lower the limits for lead, mercury and arsenic and to include a maximum limit for cadmium and for calcium oxalate. The Panel also recommended that the limits would be expressed on a saponins basis. The Panel proposed to revise the definition of E 999 to better describe the composition in a qualitative way.
AB - Quillaia extract (E 999) was re-evaluated in 2019 by the EFSA Panel on Food Additives and Flavourings (FAF). EFSA derived an acceptable daily intake (ADI) of 3 mg saponins/kg bw per day for E 999. Following a European Commission call for data to submit data to fill the data gaps, the present follow-up opinion assesses data provided by interested business operators (IBOs) to support an amendment of the EU specifications for E 999. Additionally, this opinion deals with the assessment of the proposed extension of use for E 999 in food supplements supplied in a solid and liquid form, excluding food supplements for infants and young children and, as a carrier in botanical nutrients. The Panel concluded that the proposed extension of use, if authorised, could result in an exceedance of the ADI at the maximum of the ranges of the mean for children, adolescents and the elderly, and for all populations at the 95th percentile. An additional proposed extension of use for E 999 to be used as a carrier for glazing agents on entire fresh fruits and vegetables has been received. Since no information on the proposed use levels of E 999 on a saponins content basis has been provided by this applicant, the Panel was not able to evaluate the safety of this extension of use. Considering the technical data submitted, the Panel recommended some modifications of the existing EU specifications for E 999, mainly to lower the limits for lead, mercury and arsenic and to include a maximum limit for cadmium and for calcium oxalate. The Panel also recommended that the limits would be expressed on a saponins basis. The Panel proposed to revise the definition of E 999 to better describe the composition in a qualitative way.
KW - CAS No 68990-67-0
KW - E 999
KW - Quillaia extract
KW - Quillaja extract
KW - food additive
UR - http://www.scopus.com/inward/record.url?scp=85184684218&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2024.8563
DO - 10.2903/j.efsa.2024.8563
M3 - Article
AN - SCOPUS:85184684218
SN - 1831-4732
VL - 22
JO - EFSA Journal
JF - EFSA Journal
IS - 2
M1 - e8563
ER -