Re-evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use.
CAS No 68990‐67‐0
E 999
Quillaia extract
Quillaja extract
food additive
Journal
EFSA journal. European Food Safety Authority
ISSN: 1831-4732
Titre abrégé: EFSA J
Pays: United States
ID NLM: 101642076
Informations de publication
Date de publication:
Mar 2019
Mar 2019
Historique:
entrez:
7
7
2020
pubmed:
6
3
2019
medline:
6
3
2019
Statut:
epublish
Résumé
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 (NOAELs) 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.
Identifiants
pubmed: 32626248
doi: 10.2903/j.efsa.2019.5622
pii: EFS25622
pmc: PMC7009130
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e05622Informations de copyright
© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
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