Devil not so bad in EFSA health claim details

By Shane Starling

- Last updated on GMT

Devil not so bad in EFSA health claim details

Related tags: Efsa health claim, Nutrition

At first glance yesterday’s publication of the first batch of 94 article 13.1 health claim opinions, is a worst-case scenario for industry, with claims for the likes of omega-3s, beta-glucan, folate, probiotics and taurine all drawing negative opinions from EFSA scientists.

Throw in astaxanthin, beta-glucan, glucosamine and chondroitin and October 1 begins to look like a dark day indeed for the European functional foods and food supplements industries, despite 30 per cent of the opinions being favourable.

But a closer look at the European Food Safety Authority (EFSA) claim opinions relating to 523 dossiers indicates some of the negative opinions are not as black and white as they may at first appear, with many nods to positive health associations among overall negative opinions.

This is the case with the likes of omega-3 opinions and vitamin K, for example, and health claim experts believe this opens the door for positive interpretation when the opinions are scrutinised by the European Commission and member states in the coming months.

In a statement the Commission said it “will discuss with the member states the health claims already assessed by EFSA.”

Positives in negatives

“This is what I expected,” ​said Nigel Baldwin, the senior scientific and regulatory consultant and EU manager at claims consultancy, Cantox Health Sciences. “Once the shock of all these negative opinions passes and people can take a closer at them, there are many positives to be found there.”

In the case of omega-3, while its link to the maintenance of healthy cholesterol levels had not been supported, its ability to benefit blood pressure and triglyceride levels was, Baldwin observed.

Similarly, vitamin K had not been shown to support heart health but bone and blood benefits were recognised.


It is difficult at this stage to gauge the broader response as most of the major industry groups are still processing the opinions.

A statement from the International Scientific Association for Probiotics and Prebiotics (ISAPP) reacted to the fact 10 negative probiotic opinions had been issued, a fact that has been taken up by the likes of the Wall Street Journal ​and The Independent.

“This week’s rejection of a number of claims for probiotics follows previous similar decisions by EFSA,”​ ISAPP said.

But the group refused to respond in any detail to EFSA’s opinions, opting to criticise the process for not having clear scientific guidelines.

“…it is not prudent to expect a level of substantiation of efficacy of these probiotic foods, equivalent to what is required for pharmaceutical agents,”​ ISAPP said.

“The fact that some dossiers were rejected should not be interpreted to mean that there are no substantiated probiotics, nor that products containing rejected strains have not been shown to provide health benefits to humans, nor that probiotics have failed safety standards.”

Danone vice president of external affairs and head of EU regulatory affairs, Patrick O’Quin, said none of its strains were referenced and so the global probiotics leader remained unaffected by the opinions.

Paul Chamberlain, technical director at supplements manufacturer, Solgar UK, said he was “baffled by some of the omega-3 opinions”​ that would prevent omega-3 products from making “useful statements” ​about heart and other health benefits.

“It’s very frustrating and disappointing,” ​he said.

Get on with it

Baldwin noted any doubt that remained about EFSA’s process had been removed – it is, as it said it would, employing the same “gold standard”​ criteria to all claims.

“Nothing is going to change now, the time for lobbying is over, the past 18 months have demonstrated EFSA is not going to alter its approach so companies need to look closely at these opinions and go away and make sure that future submissions fill in the data gaps.”

“But, pragmatically speaking, there is a lot of good that has come out of yesterday.”

EFSA’s opinions can be found here​.

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