DuPont Close to Finalizing Article 13.5 Probiotic Submissions

Effective on 14 December 2012, any claims that are not authorised 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.

17 Dec 2012 --- DuPont is nearing completion on several clinical studies to strengthen the scientific evidence supporting its DuPont Danisco range of probiotics with the viewto 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 14 December 2012, any claims that are not authorised 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.

In a statement to customers, the company wrote, “Interpretation of the regulation is not harmonised 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. Manufacturers are therefore encouraged 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. 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.

Example wording:
Contains "name of the culture species" example: "contains Lactobacillus acidophilus"
With "name of the culture species"  example: "with L. casei"
Any claim having the same meaning, i.e. the product contains this culture
example: "Bifidobacterium lactis added"

Local interpretation will also dictate the possibility of using brand names, as in this example:
Contains HOWARU Dophilus
Innovating in challenging times

DuPont stressed that it will continue to work with manufacturers to identify opportunities for marketing products containing DuPont Danisco probiotics together with other ingredients offering health and nutrition claims.