Safety of dried fruits of Synsepalum dulcificum as a novel food pursuant to Regulation (EU) 2015/2283.
Résumé
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on dried fruits ofSynsepalum dulcificumas anovel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is pitted and dried (by lyophilisation)fruits ofS. dulcificum. The NF contains the glycoprotein miraculin (≤2.5%) which causes sour andacidic foods to taste sweet. The fruits have a documented history of consumption in Africa andproducts thereof can be found in different markets worldwide. Information on the production processand the composition of the NF is sufficient and does not raise safety concerns. The applicant proposesto use the NF as or in food supplements for the adult population, excluding pregnant and lactatingwomen, at a maximum daily amount of 0.9 g. Taking into account these conditions of use, thePanel considers that the consumption of the NF is not nutritionally disadvantageous. The providedgenotoxicity studies do not raise concerns for genotoxicity of the NF. The Panel concludes that the onlydose tested in a 90-day oral toxicity study of 2,000 mg/kg body weight (bw) per day was notassociated with adverse effects. By applying an uncertainty factor of 200, the Panel concludes that theNF is safe at an intake level of 10 mg/kg bw per day, corresponding to a maximum daily intake of 0.7 g ofthe NF for the target population, rather than 0.9 g/day as proposed by the applicant.
Fichier principal
EFSA Journal - 2021 - - Safety of dried fruits of Synsepalum dulcificum as a novel food pursuant to Regulation EU 2015.pdf (2.18 Mo)
Télécharger le fichier
| Origine | Fichiers éditeurs autorisés sur une archive ouverte |
|---|
