76 research outputs found
Scientific opinion on the proposed amendment of the EU specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution
© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewedPublisher PD
Re-evaluation of neohesperidine dihydrochalcone (E 959) as a food additive
Publisher Copyright: © 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.The present opinion deals with the re-evaluation of neohesperidine dihydrochalcone (E 959) when used as a food additive. It is obtained by catalytic hydrogenation of a flavanone – neohesperidine – which is naturally occurring and thus isolated by alcohol extraction in bitter oranges (Citrus aurantium). Based on in vivo data in rat, neohesperidine dihydrochalcone is likely to be absorbed, also in humans, and to become systemically available. It does not raise a concern regarding genotoxicity. The toxicity data set consisted of studies on subchronic and prenatal developmental toxicity. No human studies were available. The data set was considered sufficient to derive a new acceptable daily intake (ADI). Based on the weight of evidence (WoE) analysis, the Panel considered unlikely that neohesperidine dihydrochalcone would lead to adverse effects on health in animals in the dose ranges tested. The Panel also considered that a carcinogenicity study was not warranted and that the lack of human data did not affect the overall confidence in the body of evidence. The Panel derived an ADI of 20 mg/kg bodyweight (bw) per day based on a no observed adverse effect level (NOAEL) of 4,000 mg/kg bw per day from a 13-week study in rat, applying the standard default factors of 100 for inter- and intraspecies differences and of 2 for extrapolation from subchronic to chronic exposure. For the refined brand-loyal exposure assessment scenario, considered to be the most appropriate for the risk assessment, the exposure estimates at the mean ranged from < 0.01 to 0.09 mg/kg bw per day and at the 95th percentile (P95) from 0.01 to 0.24 mg/kg bw per day. Considering the derived ADI of 20 mg/kg bw per day, the exposure estimates were below the reference value in all age groups. Therefore, the Panel concluded that dietary exposure to the food additive neohesperidine dihydrochalcone (E 959) at the reported uses and use levels would not raise a safety concern.Peer reviewe
Opinion on the follow-up of the re-evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives
Acknowledgements: The FAF Panel wishes to thank EFSA staff member(s): Jose Cortinas Abrahantes, Dimitrios Chrysafidis and Petra Gelgelova for the support provided to this scientific outputPublisher PD
Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive
Acknowledgements: The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.Publisher PD
Re-evaluation of acetic acid, lactic acid, citric acid, tartaric acid, mono- and diacetyltartaric acid, mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472a-f) as food additives
Publisher PD
Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use
Acknowledgements: The Panel wishes to thank the following for the support provided to this scientific output: Eleonora Alquati, Anna Christodoulidou and Fabiola Pizzo.Publisher PD
Re-evaluation of stearyl tartrate (E 483) as a food additive
Acknowledgements: The FAF Panel wishes to thank Claude Lambre for the support provided to this scientific output. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.Publisher PD
Re-evaluation of metatartaric acid (E 353) as a food additive
Acknowledgements: The FAF Panel wishes to thank Claude Lambre and Esraa Elewa for the support provided to this scientific output. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.Publisher PD
Safety of use of oat lecithin as a food additive
Acknowledgements: The Panel wishes to thank all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.Publisher PD
Opinion on the re-evaluation of acacia gum (E 414) as a food additive in foods for infants below 16 weeks of age and the follow-up of its re-evaluation as a food additive for uses in foods for all population groups
Publisher PD
- …