Re‐evaluation of neotame (E 961) as food additive
Laurence Castle, Monica Andreassen, Gabriele Aquilina, Maria Lourdes Bastos, Polly Boon, Biagio Fallico, Reginald FitzGerald, Maria Jose Frutos Fernandez, Bettina Grasl‐Kraupp, Ursula Gundert‐Remy, Rainer Gürtler, Eric Houdeau, Marcin Kurek, Henriqueta Louro, Patricia Morales
TL;DR
The safety of neotame, a food additive, was re-evaluated, and it was found to be safe at current usage levels.
Contribution
The study re-evaluates neotame's safety and updates the acceptable daily intake based on new assessments.
Findings
Neotame is rapidly absorbed and metabolized, with no significant genotoxicity concerns.
An acceptable daily intake of 10 mg/kg body weight per day was established, replacing the previous 2 mg/kg.
Dietary exposure estimates for neotame do not exceed the new ADI for all population groups.
Abstract
The present opinion deals with the re‐evaluation of neotame (E 961) as a food additive. Neotame is the chemically manufactured compound N‐[N‐(3,3‐dimethylbutyl)‐l‐α‐aspartyl]‐l‐phenylalanine 1‐methyl ester. The main impurity of neotame (E 961) is also a degradation product (de‐esterified form), N‐[N‐(3,3‐dimethylbutyl)‐l‐α‐aspartyl]‐l‐phenylalanine (NC‐00751) and the primary metabolite. No new data were received following the call for biological and toxicological data. A summary of the toxicological studies available in the EFSA opinion of 2007 is presented and studies gathered from the literature are summarised. Neotame is rapidly absorbed and pre‐systemically metabolised, systemic intact neotame is likely to be excreted in the urine with its metabolites. The potential aneugenic effects at the site of contact are not expected to occur; overall, there is no concern for genotoxicity of…
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Taxonomy
TopicsCarcinogens and Genotoxicity Assessment · Dye analysis and toxicity · Radiation Effects and Dosimetry