Inside Europe’s health claim conundrum

The European Union health claims process has delivered many negative opinions to claims ranging from probiotics to omega-3s in the past year, but there have also been quite a few positive decisions.

Ingredients for which approved health claims already existed in some member states such as cholesterol-lowering plant sterols and stanols and bone-related vitamin D and calcium claims have generally been OK’d by European Food Safety Authority (EFSA) scientists.

In the case of plant sterols/stanols, EFSA even went so far as to as to issue overall guidance for sterol claims after approving claims from Benecol, Unilever and Danone.

Thumbs up, thumbs down​

Of the 69 individual opinions delivered so far, about 80 per cent have been negative.

Those close to the process freely admit many of the article 13.5 (emerging and proprietary science) and article 14 (children’s and disease reduction claims) dossiers submitted so far have been weak scientifically or in their construction, and stood little chance of gaining a thumbs up from EFSA.

Claims linking consuming chocolate with children’s development or hops and breast enlargement, were never going to make the grade given EFSA’s super-meticulous approach to claim verification.

There were other examples where backing science was patently weak and it was obvious the company in question had not performed a gap analysis to determine how closely its dossier matched EFSA’s requirements.

Some companies say this is because EFSA’s requirements were not clear enough, early enough. This is part of the reason EFSA held a meeting with industry in June to clarify its approach to the mandate it was given in the 2006 EU nutrition and health claims regulation to assess more than 400 health claims.

This meeting presented no profound revelations but did emphasise key points in the methodology of EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA):

• that clinical trials hold more weight than other forms of science
• that product-specific claims must be backed by product-specific science
• that claim wording must closely match the available science
• that the physiological effect must be linked to the benefit

Good science, right science​

Some rejections were a little more surprising given the perceived strength of the submitted dossiers. Martek’s rejected DHA (docosahexaenoic acid)/ARA (arachidonic acid) infant eye and cognitive health claim surprised many, not least Martek itself, which had spent a lot of money on its dossier.

A similar omega-3 claim submitted by Mead Johnson Nutritionals in France won a partial thumb’s up, with the NDA finding the scientific data did not demonstrate ARA’s ability to benefit infant eye health, but did in the case of DHA.

Martek said it would resubmit its claim.

The omega-3 sector has not performed very well though, with many rejections although experts have commented most of the dossiers have not been strong.

As for probiotics, no claim has yet drawn a positive opinion, but some of the claims have been quite speculative, and many companies are waiting eagerly to see what EFSA decides in its first batch of generic article 13.1 claims, due for publication soon, and which is likely to contain several probiotic-based opinions.

Only then will the probiotics industry, along with many others, know exactly where it stands in terms of claims validation.

Others that have had their claims rejected including Ocean Spray (cranberry and urinary tract infection), Clasado (probiotics and gut health, immunity and traveller’s diarrhoea) and Cambridge Theranostics (lycopene-whey and heart health) have vowed to change the verdicts handed them so far.

The manner in which the European Commission interprets EFSA’s opinions is also a subject of great interest. An EC standing committee has indicated that in relation to a positive tomato extract claim about blood circulation, EFSA’s suggested wording may need reworking to make it more user-friendly.