This was the message provided by Steve Morrison, regulatory affairs manager of Atlantia Clinical Trials, during a presentation at FiE (Food Ingredients Europe) last week.
The challenges associated with successfully achieving a product health claim through EFSA are widely known, resulting from the stringent quality standards required from submitted studies, he explained. Following a year in which EFSA did not publish a single opinion on a submitted claim, these challenges look to be ever-growing.
Whilst this may, in part, have resulted from the difficulties presented by pandemic, “The real story is the transparency regulation, which has introduced another layer of challenge and complexity” clarified Morrison.
When drawing on his experience working with clients to help prove the benefits of their products, he explained “The fact I keep seeing companies make the same mistakes suggests we still have a long way to go.”
“The most important thing is to avoid these mistakes. Demonstrate reproducible cause and effect using more than one study, use the product as the core of your claim, use an appropriate population, statistics, randomisation, and control."
Regulation requirements
Since the enforcement of the EC regulation 1924/2006 on nutrition and health claims in 2017, only 11 unique proprietary claims have been approved by EFSA under article 13.5 despite the 150 scientific opinions published.
Following a consensus that there was a need for increased transparency regarding the assessments being conducted by EFSA, the new transparency regulation No: 2019/1381 was implemented to increase reliability, objectivity and independence of scientific studies. Yet, the year of silence following its implementation highlights the greater challenges it has created for researchers.
The new regulation involves potential applicants registering with EFSA and notifying the organisation of any future planned studies, from in vitro to product stability studies, to ensure visibility of any relevant research that may support an application.
This process involves two portals: EFSA connect, to ensure company visibility; and E-submission Food Chain Platform (ESFC), a platform for building and submitting dossiers.
Regarding his work on the latter with a recent client, Morrison said: “We expect we have spent 100-200 hours working in that platform to upload the e-documents. You have to say what’s propriety and what’s confidential in each document you upload and justify this. It sounds like a lot of work, and it is, but it’s manageable.”
Study quality
With regards to the studies submitted, EFSA’s health claims legislation clearly states the need for human intervention studies to inform their decision, with randomised controlled trials (RCTs) being at the top of the hierarchy of evidence for their scientific substantiation. Strong data must prove cause and effect between the food/constituent and benefit in humans, utilising a sample representative of the target population for the claim.
The importance of this in a previous case highlighted by Morrison, where two submitted meta-analyses for the product MegaNatural-BP were rejected as a result of researchers testing the grapeseed extract it contained rather than the product itself.
“If you give a package of intervention studies to EFSA to submit a health claim, the first thing they do is look at each one individually. … It’s a binary decision. They look at each one and say yes or no.
“It doesn’t matter if you submit 15 human intervention studies if they are full of methodological weaknesses and not enough data, and there’s three good ones. Just be aware that EFSA will be looking at the three good ones”, explained Morrison, stressing the importance of quality over quantity.
Discussing the rejection of the studies based on ‘methodological weaknesses’, such as the lack of power calculations and randomisation details, he added “This is a phrase we hear all the time when they’re assessing individual studies”,
Quantity queries
With regards to the 11 claims achieved, Morrison drew attention to the attrition that has taken place in the submission of studies. As a result, three to five high quality RCTs can be enough to achieve a health claim.
“One study will never be enough, because you cannot prove reproducible cause and effect. You must have at least two studies to show in two research studies you have reproducibility.
“It’s not about having vast amounts of studies; it’s about having consistency and quality in the ones that you deliver,” he concludes.