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Reasons unknown: Merck and Chr Hansen pull EU probiotic allergy health claim

1 comment12-Feb-2013
Last updated on 12-Feb-2013 at 21:55 GMT

Reasons unknown: Merck and Chr Hansen pull EU probiotic allergy health claim

German pharma giant Merck and global probiotics leader Chr Hansen have pulled the probiotic-allergy health claim they jointly submitted to the European Food Safety Authority (EFSA) less than four months ago.

The two firms would say nothing about what sparked the sudden about-face, whilst affirming the strength of their data linking Chr Hansen’s Lactobacillus paracasei LP-33 probiotic strain and allergy resistance in adults.

Chr Hansen would not comment on the withdrawal while Merck said: "Although we are convinced that the data presented were well documented to  substantiate a health claim, we have decided to voluntarily withdraw our health claim submission in Europe.”

“We remain committed to investing in clinical R&D to develop innovative products that benefit consumers of food supplements. However, we will initiate constructive dialogue with EFSA to ensure that our investments in gold-standard clinical trials can be turned into meaningful health claims."

The article 13.5 claim was lodged under the EU nutrition and health claims regulation (NHCR) via Merck’s French arm, Merck Médication Familiale.

At the time of submission, Chr Hansen’s director of scientific affairs in health and nutrition, Birgit Michelsen, said a verdict was expected, “during spring 2013”.

1 comment (Comments are now closed)

Encapsulated Probiotics

One problem with encapsulated probiotic bacteria resulted in Canada from the use of undeclared milk protein used in the coating makeup. Allergen issues promoted the recall. A valid reason to withdraw a claim.

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Posted by Larry Whetstone
18 February 2013 | 23h16

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