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NHCR article 13 health claims fallout

Valio: How a probiotic firm exists in the “red ocean” of EU health claims

By Shane Starling , 14-Jan-2013
Last updated on 14-Jan-2013 at 18:04 GMT2013-01-14T18:04:04Z


Crittenden: "...we are endeavoring to focus our clinical nutrition research in areas that would provide a competitive edge over the large ‘red ocean’ created by the 13.1 list.”

Finnish dairy and probiotics firm Valio says EU health claim laws are forcing it to add approved vitamins and minerals to products like probiotics that have failed to win EU health claims.

Valio VP in R&D Ross Crittenden said the European Union nutrition and health claim regulation (NHCR) had created a “red ocean” of rejected claims of 1000s of claims that included about 300 rejections for various probiotic strains including Valio’s.

“The generic list of allowable claims for simple ingredients, such as vitamins and minerals, is so extensive that it is now possible to formulate and promote products with any myriad of health claims,” Crittenden said ahead of presentations the chair of the Global Alliance for Probiotics (GAP) will give at upcoming Probiotech and Microbiota conference in Brussels on February 5-6.

Crittenden raised the oft-spoken crimping of innovation as another side-effect of the NHCR’s article 13 list of approved and rejected claims.

“As an example, using the natural components present in milk it is possible to apply up to 10 health claims. This means that it is very difficult to justify the risk and expense of developing a new ingredient, for which the health claim may not be sufficiently differentiated in consumers’ minds from those which can be applied by incorporating ingredients on the 13.1 list.”

“Red ocean”

He added: “The failure to gain probiotic claims thus far and the ratification of the 13.1 list is a double blow for the development of new probiotic ingredients.”

“Food manufacturers are already re-formulating products to maintain current consumer health messages and questioning investments in new clinical research to support currently unapproved health claim ingredients.”

“At Valio, we are endeavoring to focus our clinical nutrition research in areas that would provide a competitive edge over the large ‘red ocean’ created by the 13.1 list.”


Crittenden, speaking as GAP chair, said probiotics had been rejected under the NHCR despite the fact the European Union itself had spent around €70m on research associated with the strains.

“One of the reasons that applications for probiotic claims have not been accepted by EFSA is that the first guidance note on gut and immunity claims were only provided in April 2011, more than two years after the deadline for submission of Article 13.1 claims-dossiers.”

“The current guidance, being by necessity generic, also leaves many open questions in the design of probiotic clinical trials and the preparation of claims dossiers in this new and relatively complex field of science.” 

“The absence of a mechanism by which applicants can get adequate feedback prior to embarking on expensive human trials or submitting dossiers is, in many cases, paralyzing companies’ confidence in investing in new science.”

Probiotech and Microbiota 2013

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