No safety concerns over neotame, says EFSA

Neotame, which was developed by The NutraSweet Company in the US, is a derivative of aspartame.

It is said to be around 7,000 to 13,000 times sweeter than sugar, but to have a sugar-like taste and no calories.

It is also said to be 30 to 60 times sweeter than aspartame, depending upon the food application.

Its proposed use is as a sweetener and flavour enhancer as a replacement for sucrose and other sweeteners in a range of products including carbonated and non-carbonated soft drinks, as well as beverage mixes, dairy beverages, non-dairy desserts, ice creams and sorbets, yoghurts, confectionery, chewing gum, fruit preparations and salad dressings.

Approval in Europe would open up a huge new market for the additive, and give manufacturers a new tool in a competitive marketplace for sweeteners that has been marred by safety fears in the past - but where there is great potential for sugar replacements in better-for-you products.

Neotame is already approved for use as a food additive in several countries, including the US, Australia, New Zealand and Mexico and, following an evaluation by the Joint FAO/WHO Expert Committee on Food Additives in 2003, was assigned a an acceptable daily intake of 0-2 mg per kg of body weight.

It remains unapproved in the EU, however, despite EFSA having originally having been asked to provide a scientific opinion on safety record in May 2003 - and a decision was expected late 2004.

An EFSA spokesperson was unable to comment on any reasons for the timeframe prior to publication deadline.

The regulatory decision following EFSA's opinion now rests with the European Commission.

In its opinion, published in the The EFSA Journal (2007) 581, 1-43, the authority's Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food concluded that "neotame is not carcinogenic, genotoxic or associated with any reproductive/developmental toxicity".

Its opinion is based on assessment of animal studies on diet preference, sub-chronic effects, chronic effects, carcinogenicity, reproductive and developmental toxicity, and genotoxicity.

The human clinical testing programme was to evaluate metabolism and pharmacokinetics, and safety in healthy subjects and those with diabetes.

The panel also looked at data on stability and degradation products.

The only negative effect in the animal studies was seen to be increased activity in alkaline phosphatase of hepatic origin in dogs that were given very large doses of between 600 and 1200 mg per kg of body weight in 13- and 52-week trials.

It said that the no-observed-adverse-effect level (NOAEL) was 200 mg per kg of body weight, and therefore established an ADI of 0-2 mg per kg body weight.

This was calculated on the bases of a 100-fold safety factor.

"Conservative estimates of neotame dietary exposure both in adults and children suggest that it is very unlikely that the ADI would be exceeded at the proposed use levels".

Typical usage levels vary from eight to 17 mg/kg for beverages, and from 15 to 35 mg/kg for solid foods.

For gums, the typical usage level would be 250 mg/kg.

A report from US research firm The Freedonia Group projected that demand for alternative sweeteners in the US would increase 4 percent per year, to reach $1.1bn in 2010 - up from $772m in 2000 and $935m in 2005.

It said that neotame remains a relatively new product, and has not as yet established a strong market presence.