Cognis to Submit Article 13.5 Dossier to EFSA for Lutein Esters

It will submit a dossier to EFSA with additional new science, including studies conducted with its Xangold branded ingredient. This move follows the EFSA’s recent rejection of a health claims dossier submitted by member states for lutein products.

9 Mar 2010 --- Cognis Nutrition & Health, the world’s leading producer of natural lutein esters, has announced that it will submit a dossier to the European Food Safety Authority (EFSA) with additional new science, including studies conducted with its Xangold branded ingredient. This move follows the EFSA’s recent rejection of a health claims dossier submitted by member states for lutein products.

Cognis will submit this new information under article 13.5 of the European Community nutrition and health claims regulation. The company is appealing the EFSA opinion cited in article 13.1 by presenting a comprehensive new submission with the new scientific data.

“While we were initially disappointed in the EFSA ruling, in reviewing the opinion, we have identified areas that can be more clearly supported with strong scientific evidence that has evolved since the original submission was completed over three years ago,” said Holger Becker, PhD, Xangold Global Product Manager, Cognis Nutrition & Health.

Dr. Becker pointed out that it is important for customers and prospects to understand that Xangold continues to be a fully approved ingredient in the EC and can be used for multiple nutritional applications. “The EFSA opinion is limited only to proposed health claim labeling so nothing has really changed regarding the regulation of lutein esters as a nutritional ingredient. Now our focus is on the future and how we effectively provide the evidence EFSA requires so that the appropriate health claims can be used by our customers,” he said.

Xangold natural lutein esters are a highly bioavailable source of lutein and appeal to manufacturers for their stability and long-lasting potency. Xangold is extracted from marigold flowers grown specifically for Cognis and is available as oils and beadlets. Scientific studies have consistently shown that lutein from lutein esters has equivalent bioavailability, and may be even superior to that of free lutein. The Xangold product line offers non-GMO, kosher and vegetarian-source lutein esters for a variety of product applications. Xangold was the first source of lutein to complete the FDA GRAS notification process in January 2003.