DuPont is nearing completion of several clinical studies to strengthen the scientific evidence supporting its DuPont Danisco range of probiotics with the view to submit new Immune and Gastrointestinal Health claim dossiers for review by EFSA under Article 13.5 of Regulation (EC) No 1924/2006. This is being done in accordance with the "Guidance on the scientific requirements for health claims related to gut and immune function" provided by EFSA in April 2011.
Effective on December 14, 2012, any claims that are not authorized or under consideration by EFSA will be prohibited. The word probiotic is considered a claim in itself due to the definition "... confer a health benefit on the host" and therefore is also not permitted.
Interpretation of the regulation is not harmonized throughout the EU. Some countries will likely allow content claims, while others may take the view that content claims will be perceived as indirect health claims. DuPont encouraged manufacturers to consult with local authorities before making their own determination for how to represent probiotics on their label.
One option in many countries could be for manufacturers to move to content claim language while DuPont addresses the current dossier with additional clinical studies to support immune and digestive health claims, the company said. Food, beverage and supplement products can continue to contain DuPont™ Danisco probiotics, although health claims are not legally authorised on product labels or other marketing materials. Thus, content claim language could be used as an alternative tool to communicate premium products.
DuPont Builds Case for EFSA Health Claim Dossiers