Data demands unchanged

Industry response: New EFSA health claim guidance makes applying easier, but science requirements remain the same

By Shane STARLING contact

- Last updated on GMT

Industry response: New EFSA health claim guidance makes applying easier, but science requirements remain the same

Related tags: Efsa health claim, Nutrition

EU health claim specialists say EFSA guidance issued last week clarifies application procedures but changes nothing of the infamous pharma-style scientific requirements that have denied 1000s of claims across the EU bloc of 28 nations.

The guidance​, issued for the first time since 2011 by EFSA's Panel on Dietetic Products, Nutrition and Allergies (NDA), was useful since it blew the dust off the previous one” ​said Dr Jerome le Bloch of French claims consultancy NutraVeris.

The structure of the application is clearer. That can be only a good thing for stakeholders.”

But Dr le Bloch was scathing about what was absent in the guidance, stating “EFSA ‘experts’ continue to do their best to ignore the needs and requirements of industrials.”

“Once again, the public consultation has not been followed by EFSA…”

The fact only 10 firms and organisations contributed to an eight-week public consultation​last summer indicated a grim business reality under the 2006 nutrition and health claims regulation (NHCR), he said.

“One may believe the food industry has given up any discussion with EFSA and that EFSA will stay cloistered in its bubble far away from the reality.”

Useful for first applicants

Steve Morrison from Atlantia Food Clinical Trials & P2F Ventures Limited said the guidance was an “exercise in re-formatting the applications rather than making substantial changes to the data that will be part of future applications.”

Morrison added: “Whilst this updated guidance will undoubtedly be a useful reference point for health claim applicants the timing of its appearance could be challenging for companies already nearing the completion of their applications or who have already created working draft applications.   These health claims dossiers can take several months to compile and there will undoubtedly be some companies who will face some last minute challenges to re-format their applications.” 

“The new guidance is a little more ‘wordy’ than the 2011 version and has lost some of the simplified diagrams used, for instance, to show the dossier structure.  As not all applicants have English as a first language I certainly felt that those diagramatic representations were useful in the past and could have been retained.”

He said overall the guidance would be “of great value to those applicant making their first submissions.” 

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