How to build an article 13.5 dossier

By Shane Starling

- Last updated on GMT

Related tags: Soy protein, Nutrition

The rejection of so many health claim submissions by the European Food Safety Authority is creating a major headache for the EU functional foods and food supplements industries, with many looking at resubmissions under article 13.5 of the regulation.

Here two experts in building health claims dossiers focus on two recently rejected and high profile claims for soy protein and conjugated linoleic acid (CLA), exploring the reasons for rejection and what they could do under 13.5.

Soy protein

Looking at the soy protein failure, Cedric Bourges, the founder and managing director of Nutraveris said: “The claim has been asked on protein and the studies provided were more generally speaking with soy isolates that were not 100 per cent soy protein. In a way it comes back to the selection of studies.”

For Nigel Baldwin, senior scientific and regulatory consultant and EU manager at Cantox Health Sciences, rejections were not always as bad as they appeared because there was much that could be learned from them.

“So I think really the constructive way to treat something like the soy protein application is to treat it as a really good gap analysis…EFSA is clearly saying in that opinion that you haven’t presented the information to us in a way you can accept – not that we won’t accept it.”


For CLA, Borges suggested a reason for the article 13.1 claim’s failure to impress EFSA’s health claims panel could have been that it was too broad, and asked for too much.

“Don’t try to have all the claims,” ​he said. “Focus on what you’ve shown, what is pertinent, what gives results.”

Baldwin added: “Art 13.1 was never adequate for you to be able to explain the complexity of the claim.”

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