European zeaxanthin safety opinion may damage industry

By Shane Starling

- Last updated on GMT

Related tags Dietary supplement Food and drug administration

The recent European Food Safety Authority (EFSA) opinion that the eye-health ingredient zeaxanthin is not safe for use in dietary supplements is potentially damaging to industry, according to Michigan-based botanicals supplier, Kalsec.

“The EFSA safety opinion on zeaxanthin is being misinterpreted,” said Gary Hainrihar, Kalsec executive vice president of business development.

 He noted that although the opinion referred to dietary supplement consumption up to 20mg per day, the opinion was open to interpretation that zeaxanthin has general safety issues, which even EFSA acknowledged do not exist.

The regulator simply stated there was insufficient science at this point in time to back the DSM claim that 20mg per day per person was safe in dietary supplements.

But this opinion was enough to provoke the likes of Hainrihar into stating, “some members of the functional food and nutritional supplement industry are interpreting the judgment as an expression of concern over the safety of zeaxanthin in general.”

In response, Illinois-based supplier Chrysantis managing director Manuel Pavon told industry has nothing to fear from the opinion.

“The DSM application was unusual in that it sought such a high dose but industry shouldn’t be damaged by the fact EFSA rejected it,” ​he said. 

“The fact is industry has a very level of knowledge of these issues and when it comes to toxicology, there is no way they would deal with an unsafe ingredient. If you were a consumer and you read about it on the front page of the​ New York Times you might be worried, and so would we, but this is a technical business issue and it should be treated as such.”

Mounting evidence suggests zeaxanthin, along with lutein and other phytonutrients, can benefit eye health and ward off the onset of conditions such as age-related macular degeneration (AMD) – a condition that typically effects older people – as well as cataracts.

Chrysalis has Food and Drug Administration GRAS (generally recognized as safe) approval in the US for dosage up to 2mg per day.

It recently expanded its marigold-derived ​EZEyes range to include a stable oil suspension.Although the market for zeaxanthin is relatively small (about $2-3m in the US) compared to its more high profile relative, lutein, the market is growing as its profile grows.

It tends to be more expensive than lutein at about $10 per gram compared to lutein which can sell for as low as $1 per gram, although zeaxanthin is typically used in lower volumes.

In its opinion EFSA stated:

"The proposed levels of use of up to 20 mg/person/day of synthetic zeaxanthin as an ingredient in food supplements would lead to intake levels that would substantially increase the average dietary intake of synthetic zeaxanthin resulting in up to 100 times higher intakes for adults.”

"These intake levels are within the range of the group ADI 0-2 mg/kg body weight for luteinand synthetic zeaxanthin as established by JECFA. However, in the opinion of the Panel, the toxicological data on synthetic zeaxanthin are not sufficient to derive an acceptable daily intake."

Related topics Botanicals Eye health

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