Open AccessRe‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use
Author(s) -
Younes Maged,
Aquilina Gabriele,
Castle Laurence,
Engel KarlHeinz,
Fowler Paul,
Frutos Fernandez Maria Jose,
Fürst Peter,
Gürtler Rainer,
GundertRemy Ursula,
Husøy Trine,
Mennes Wim,
Oskarsson Agneta,
Shah Romina,
WaalkensBerendsen Ine,
Wölfle Detlef,
Boon Polly,
Lambré Claude,
Tobback Paul,
Wright Matthew,
Rincon Ana Maria,
Smeraldi Camilla,
Tard Alexandra,
Moldeus Peter
Publication year - 2019
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2019.5622
Subject(s) - acceptable daily intake , food additive , genotoxicity , toxicology , food science , reference dose , tolerable daily intake , food packaging , food safety , body weight , chemistry , mathematics , risk assessment , medicine , biology , pesticide , toxicity , computer security , organic chemistry , computer science , agronomy
Abstract The EFSA Panel on Food Additives and Nutrient Sources added to Food ( ANS ) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food ( SCF ) in 1978 established an acceptable daily intake ( ADI ) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO / WHO Expert Committee on Food Additives ( JECFA ) established in its latest evaluation a group ADI of 0–1 mg/kg bw per day, expressed as quillaia saponins, for Quillaia extract for Type 1 and Type 2. The Panel considered it likely that intact Quillaia extract saponins are absorbed to a low extent, are hydrolysed in the gastrointestinal ( GI ) tract and that the aglycone is absorbed only to a limited extent. The Panel considered that the genotoxicity data available did not indicate a concern for genotoxicity. Taking into account the available toxicological database, various no observed adverse effect levels ( NOAEL s) relevant for the derivation of an ADI were identified. The Panel considered that the 2‐year study in rats was the most robust and that the NOAEL of 1,500 mg Quillaia extract/kg bw per day could be used to derive the ADI for E 999. Considering that the adverse effects reported were due to the presence of saponins in the extract, that saponins were present in Quillaia extract Type 1 (around 20%) and using an uncertainty factor of 100, the Panel derived a ADI of 3 mg saponins/kg bw per day for E 999. None of the exposure estimates for the different population groups of the refined brand‐loyal scenario exceeded the ADI of 3 mg saponins/kg bw per day. The proposed extension of use also would not result in an exceedance of this ADI for the refined scenario. The Panel proposed some recommendations for the European Commission to consider, in particular revising the EU specifications for E 999 in order to differentiate the extracts of Quillaia according to the saponins content and to include other parameters to better characterise the food additive.