Consultation on the Determination of the Status of a Novel Food: Standardised Lutein and Zeaxanthin Extract from Tagetes erecta L. in Oil Suspension

"Germany's competent authorities consulted the European Commission and other EU Member States regarding the novel food status of a standardised lutein and zeaxanthin extract from Tagetes erecta L. in oil suspension. The product is produced by extracting lutein and zeaxanthin from Tagetes erecta L. flowers, followed by saponification and purification, and standardised by dilution with sunflower oil. The extract contains 20–24% trans-lutein, 4–5% zeaxanthin isomers, and 66–70% sunflower oil.​ The consultation concluded that this product is not considered a novel food when used exclusively in food supplements. This decision aligns with a similar consultation conducted by the Czech Republic in 2022, which determined that a comparable product was not novel. The mutual recognition principle was applied, considering the same source material, production method, and substances present in the extract. However, if the extraction process is modified to enhance solubility or bioavailability, the product may qualify for a different status as a novel food."