Neotame
Score impact
0.00
points/product
Description
Neotame (E961) is a high-intensity artificial sweetener, approximately 7,000 to 13,000 times sweeter than sucrose. It belongs to the family of dipeptides derived from aspartic acid and phenylalanine, similar to aspartame but with a modified structure that provides greater stability and sweetening power.
It was developed by NutraSweet and first approved in the United States in 2002. In the European Union, it was authorized as a food additive in 2010 after evaluation by the European Food Safety Authority (EFSA). The World Health Organization (WHO) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an Acceptable Daily Intake (ADI) of 0-2 mg/kg body weight.
Neotame is obtained by chemical synthesis from aspartic acid, phenylalanine, and an isocyanate compound. It is a white crystalline powder, soluble in water, and stable at high temperatures, allowing its use in baked goods. Its main function is to sweeten without adding calories, and it is used in a wide variety of foods and beverages. The safety of Neotame has been supported by multiple toxicological studies that have shown no significant adverse effects in humans within the ADI limits. On labels, it must appear as "sweetener: neotame" or "E961".
Although it shares a structure with aspartame, Neotame is not metabolized to phenylalanine in significant amounts, so it is safe for people with phenylketonuria (PKU) as long as it is consumed within established limits. However, EFSA recommends that products containing neotame include a warning about phenylalanine if they exceed certain levels, although in practice it is not mandatory.
In summary, E961 is a safe and versatile sweetener widely used in the European food industry.
Neotame is used as a tabletop sweetener, in non-alcoholic beverages, desserts, dairy products, confectionery, chewing gum, breakfast cereals, and baked goods.
In the Spanish market, it is found in light or zero soft drinks, low-fat yogurts, sugar-free gelatin, and sugar-free chewing gum. Regulation EC 1333/2008 sets maximum limits that vary by category: for example, in non-alcoholic beverages up to 20 mg/L, in desserts up to 100 mg/kg, and in tabletop sweeteners up to 60 mg/kg. In the United States, the FDA approved it for similar uses with specific limits. In Japan, its use is permitted but with additional restrictions.
Compared to other sweeteners, Neotame offers an advantage due to its high thermal stability, allowing its use in products that require cooking or baking, unlike aspartame which breaks down with heat.
Toxicological studies conducted by EFSA and JECFA have not identified significant adverse effects in humans when consumed within the ADI (0-2 mg/kg/day). At very high doses (far above the ADI), mild effects such as headache or gastrointestinal discomfort have been observed in some individuals, but these are not considered clinically relevant.
Neotame is rapidly metabolized to N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester and other compounds that are excreted without accumulation. Unlike aspartame, it does not produce free phenylalanine in significant amounts, so it does not pose a risk for people with phenylketonuria (PKU) under normal consumption conditions.
No interactions with medications have been documented. EFSA concludes that Neotame is not genotoxic, carcinogenic, or toxic to reproduction.
In summary, it is considered safe for the general population, including children and pregnant women, as long as the established limits are respected.
- Neotame
- N-(N-(3,3-dimethylbutyl)-L-α-aspartyl)-L-phenylalanine 1-methyl ester
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