EC offers rejected probiotic health claim hope with resubmission offer

By Shane Starling

- Last updated on GMT

The EC has opened a three-month window for the submission of new data to back some rejected claims
The EC has opened a three-month window for the submission of new data to back some rejected claims

Related tags European union

The European Commission is giving member states the opportunity to submit new data to back general function, article 13.1 probiotic claims rejected for being insufficiently characterised.

More than 200 general function probiotic claims have been rejected by the European Food Safety Authority (EFSA) health claims panel over the four batches it has so far produced. Many dossiers were not scrutinised because the probiotic strains were deemed insufficiently characterised.

Now the EC is offering hope to those rejected submissions, along with those where EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) drew an “insufficient evidence”​ conclusion rather than an outright, “cause and effect has not been established” ​condemnation of the data.

A four-month window that opened on June 1 and closes on September 30 will allow stakeholders to submit data to member state bodies who than have a further month to scrutinise and forward the data to the EC.

Micro-organism distinction

On the characterisation issue the EC letter written by Paola Testori Coggi said because many micro-organism submissions had inadvertently turned out not to be sufficiently characterised due to a lack of guideline clarity around “genotypic identification”, ​resubmission of data was advisable.

“For this reason the Commission feels it is justified to make a distinction between micro-organisms and other claims where the subject of the claim is not sufficiently characterised, and allow the submission of more specific evidence for a further assessment of claims on micro-organisms only,”​ Testori Coggi wrote.

Insufficient evidence verdicts

The Commission said the fact many NDA verdicts found dossier evidence “insufficient”​ opened the door to further submission of data.

“As the evidence substantiating the national lists were being compiled and submitted pursuant to article 13(2) of the regulation was provided prior to 31 January 2008, it is judged appropriate to allow any new evidence that emerged subsequently to be taken into account in the evaluation of these claims.”

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