Dispatches from Hi Europe

EFSA panel member spells out lessons for health claim applications

By Nathan Gray contact

- Last updated on GMT

“If you don’t have good scientific data, your health claim will not make it," warns Professor Hans Verhagen.
“If you don’t have good scientific data, your health claim will not make it," warns Professor Hans Verhagen.

Related tags: Health claim, Health claims, Nutrition

Good science and trial design must be a focus for companies putting together new health claims dossiers, but that may not mean what you think it does, says NDA Panel member Hans Verhagen.

Speaking to delegates at the Hi Europe exhibition and conference, the EFSA expert dished out a key list of ‘take home messages’ for the food and ingredients industry to consider when preparing to submit new health claims dossiers.

The Dutch-based professor warned that while many consultants and companies believe that EFSA needs to set out more detailed guidelines, and in some cases provide a formulaic checklist of what needs to go in an application – the reality of the EFSA approach is very different.

“You need to provide an argument, not a set number of studies that meet a certain formula,”​ said Verhagen, noting that if one good clinical study provides a robust and ‘convincing’ argument for the substantiation of a claim, then that may be enough.

“You may also need ten,”​ he commented. “There is no pre-fixed number of studies.”

Indeed Verhagen, who is also senior scientific advisor nutrition and food safety at the Dutch National Institute for Public Health and the Environment (RIVM), warned that firms should not ‘look for magic recipes’ for health claims success.

“Magic recipes do not work. They do not exist,”​ said the EFSA scientists. “Provide a good scientific rationale, and do it to the highest possible degree.”

Getting the right claim … and a good argument

“When you want to have a health claim on your food, good science is pivotal,”​ Verhagen told delegates.

“If you don’t have good scientific data, your health claim will not make it.”

He also reminded the industry that it is not EFSA that devises a health claim – warning that it is the applicant that should comes up with specific claims, and that it is then their responsibility to argue its scientific merit using the best science available.

“You need to submit a dossier that about that claim,”​ he reiterated. “It is not that EFSA can say ‘OK give the dossier to me and I will figure out the most appropriate health claim for you’.”

“There may be people in agencies that will do that for you, but that is not the job of EFSA.”

“You need to provide an argument, a good scientific rationale.”​ 

Don’t make silly mistakes

Verhagen also warned that many unsuccessful health claims dossiers have fallen at the most basic of hurdles – such as failing to characterise an ingredient or using inappropriate biomarkers for a study.

“Do your homework, read a lot. Read commission guidelines, and existing EFSA opinions … see why things were turned down, see what might make things work,” ​said the RIVM scientist. 

“Do not use a biomarker that EFSA have already said is not a valid biomarker. It happens a lot in the antioxidant area, for example." 

“Go for the validated markers.”

He also said that many health claims dossiers have failed on basic areas such as characterising the ingredients – noting that more than 100 probiotic claims failed at the first hurdle since they did not sufficiently characterise the bacterial strains concerned with the dossier.

“We didn’t know what it is,”​ said Verhagen.

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1 comment

Scientific incoherence

Posted by Bryan Hanley,

Many of the efforts that EFSA have made to rationalise health claims for dietary constituents are welcome however the basis for the thinking is primarily reductionist in nature with a smattering of medicinal chemistry. This prolongs the Ehrlich 'magic bullet' as a curative based paradigm rather than a healthy homeostasis approach. The real tragedy is that there are dietary interventions that could make a real difference to healthy lives which are not being made, not being researched and not being offered because of box ticking by EFSA experts. The impetus seems to be towards refusing claims unless they tick all the boxes rather than measuring beneficial impacts.
This is not a plea on behalf of poor science but a comment that the current EFSA paradigm fails science, industry and, most of all, the consumer.
While we as scientists are busy forming committees and demonstrating how clever and good we are at picking other people's science to pieces, people are failing to maintain their health through diet because they do not know who, or what to believe.
We can and must do better.

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