E961 — Neotame
E961 (Neotame), a sweetener, is rated "safe": no significant concern. An ultra-intense synthetic sweetener (7000 to 13000 times sweeter than sugar). Related to aspartame but does not break down into phenylalanine in the body. EFSA raised the safe daily limit in 2025.
What is Neotame?
A synthetic sweetener roughly 7000 to 13000 times sweeter than sugar. A chemical relative of aspartame but with a structural change that blocks its breakdown to phenylalanine, making it safe for people with phenylketonuria. Used in baked goods, dairy, and gum, but uncommon overall.
What does it do to the body?
Your body rapidly absorbs, metabolises, and excretes it within a day. EFSA's 2025 review found no genotoxicity, carcinogenicity, or metabolic concerns at permitted use levels.
What regulators say
EFSA raised the acceptable daily intake to 10 mg per kg of body weight per day in July 2025, up from 2 mg, after a full re-evaluation. The FDA approves it without restriction.
Risk rating: Safe
Cleared by EFSA with no significant concern at typical dietary exposure. Common, well-studied, and not a reason to put a product back on the shelf.
Source: EFSA — re-evaluation of neotame (2025) ↗