DSM and Kemin to Seek Further Clarity on EFSA Lutein Claim Rejection

This is a claim originally submitted in the draft article 13 list in 2006 as authorized by France in 2004. However the newly issued opinion is again expressed as “insufficient”.

8 Jun 2012 --- DSM Nutritional Products (DSM) and Kemin will seek further clarity regarding the opinion issued by EFSA on June 5, 2012 pertaining to lutein and maintenance of normal vision. The EFSA opinion was issued following submission of a comprehensive dossier by both companies substantiating a health claim in relation to lutein’s antioxidant benefits for eye health. This is a claim originally submitted in the draft article 13 list in 2006 as authorized by France in 2004. However the newly issued opinion is again expressed as “insufficient”. This is the second consecutive time that EFSA has drawn such a conclusion, which the companies state is unprecedented in the current claims initiative. In addition, the opinion relates to “maintenance of normal vision” which is seemingly different from the requested claim.

The EFSA opinion was issued in response to a dossier submitted by DSM and Kemin, in September 2011, seeking authorization for the following health claim: “Lutein, a constituent of the retina and the lens, contributes to protecting these tissues from oxidative damage”. DSM and Kemin firmly believe there is a consistent body of evidence demonstrating lutein’s antioxidant effect in in vitro and animal eye models. Studies on humans further report that lutein can protect the retina from additional oxidative damage caused by blue light. As recognized by the EFSA, “the protection of body cells and molecules (…) from photo-oxidative damage may be a beneficial physiological effect, assuming that any significant oxidative modification of the molecule is potentially harmful” (EFSA Journal 2011;9(12):2474). Thus lutein, acting as an antioxidant in the eye, may exert a protective effect against oxidative stress, which is beneficial to eye health.

The EFSA opinion is inconsistent with an earlier opinion issued by the French Food Safety Agency (AFSSA) in January 2004, which, after reviewing a dossier submitted by DSM and Kemin, determined that the two following claims were scientifically justified: “Lutein helps protect the retina and the lens from the oxidation” and “Lutein is one (of the) constituent(s) of the retina and the lens”. It is further inconsistent with determinations of ANVISA (Brazilian Health Surveillance Agency) and the Natural Health Products Division of Health Canada, which have authorized antioxidant claims for lutein.

The June 5, 2012, opinion only addresses the proposed health claims that can be made on labeling of finished products but does not alter the ingredient’s regulatory status. FloraGLO Lutein retains its status as a lawful ingredient that may continue to be used by our customers in their food supplements and food. With this second consecutive inconclusive opinion it is unclear at this stage how the Commission will decide to proceed.

Consequently DSM and Kemin will continue to pursue long-term acceptance of eye health claims in the EU for products containing FloraGLO Lutein and will be actively reviewing additional, new health claim applications to ensure FloraGLO Lutein customers may continue to label their products with information about its important benefits for eye health, the companies reported in a statement.