Last July the ANS panel of the European Food Safety Authority established an ADI of 1mg/kg bw/day for natural lutein (E161b) from Tagetes ereta, a marigold from Mexico, with at least 80 per cent carotenoids lutein and zeathanthin. (79 and 5% respectively).
This ADI was based on the NOAEL of 200mg/kg bw/day, the highest level tested, from a 90 day rat study. The uncertainty factor of 200 per cent was down to the lack of a multigenerational reproductive toxicity study, and of chronic toxicity/carcinogenicity studies.
However following the publication of the opinion the Natural Food Colours Association (NATCOL) and the European Chemical Industry Council (CEFIC) wrote to EFSA to point out that some data on lutein esters do exist that could fill some of the gaps it identified.
All the studies they forwarded related to a specific lutein ester preparation from Tagetes erecta with more than 60 % total carotenoid esters, of which 93 per cent were lutein and the rest zeaxanthin.
In light of this the panel proposed to EFSA that it re-evaluate the safety of the other lutein preparations.
The extension of the ADI to lower carotenoid levels will aid the adoption of natural lutein colour in foods and beverages, at a time when food manufacturers are turning away from synthetic colours – and in particular the so-called Southampton Six, which necessitate a warning label on hyperactivity in children on any food product in which they are used in Europe.
The new studies sent up industry covered the nature and levels of the terpenoids that may be present in the extract. In the new opinion the panel acknowledges that the essential oil from the marigold flowers can contain D-limonene, cis- and trans-ocimene, linalool, alpha-D-phellandrene, and others.
These are very volatile and are likely to be removed during the manufacturing process, but in any case the panel said that since terpenoids may be of toxicological relevance, specifications may need to be updated to indicate the type and level of terpenoids present in the preparation.
Other studies looked at bioavailability and genotoxicity, and founds no concerns. Lutien esters were seen to be as bioavailable as lutein in its free form, as they are hydrolysed during digestion.
However the panel concluded that “the toxicological database available is too limited to conclude that the ADI also applies to lutein preparations of lower purity or from other sources”.