How are functional food claims regulated in the EU – summary
- Functional food claims in the EU must be pre-approved by regulators
- The European Commission authorises claims after EFSA’s scientific assessment
- Only 16 changes have been made to the approved claims list since 2012
- Probiotic and fibre-related claims are often rejected due to weak evidence
- Botanical claims remain in limbo under a suspended and unresolved framework
Consumers want functional food. If nothing else is certain, that is.
In many areas, from coffee to bread to plant-based protein to non-alcoholic drinks, consumers want food that can provide functional benefits beyond taste, texture and satiety.
When their food provides these functional benefits, manufacturers naturally want to let consumers know; in other words, to provide on-pack health claims.
But making health claims is easier said than done. How does the EU regulate this? What hoops do functional food manufacturers need to jump through before getting their claims on-pack?
Which regulations cover functional foods?
Claims on functional health are regulated as claims relating to to growth, development and function of the body, slimming and weight control, or behavioural and psychological functions, explains Katia Merten-Lentz, partner at law firm Food Law Science and Partners.
They are regulated separately from claims relating to either harm reduction or to children’s health, and are much easier to get than these claims.
Because claims on functional foods refer to the functions of the body, rather than simply the abundance of a certain nutrient, they are considered health claims rather than nutritional claims, explains Manon Ombredane, director at law firm Squire Patton Boggs.
While the European Food Standards Authority (EFSA) provides scientific evaluation and assessment, it is the European Commission that actually regulates health claims. Health claims made on foods are prohibited unless authorised by the Commission.
In 2008, member states were given the opportunity to submit health claims to the Commission, and received more than 44,000 claims, which were submitted to EFSA for assessment.
EFSA finalised these assessments by the end of 2011, and in 2012, the Commission came up with a list of permitted health claims (with the exception of those related to harm reduction or children’s development). This list has only been amended 16 times since then.
The most recent amendment was in July 2025, to health claims on kiwifruit. This authorised manufacturers to make the claim that “consumption of green kiwifruit contributes to normal bowel function by increasing stool frequency”.
Which health claims are difficult to get approved?
“In certain areas there is a strong trend of submitting health claims, but also a correspondingly high likelihood that EFSA will reject them,” explains Food Law Science and Partners’ Merten-Lentz.
One of these areas is claims relating to microorganisms, especially probiotics. Numerous EFSA assessments of such claims have been rejected, and only one has been authorised.
There is much controversy surrounding the EU’s approach to probiotics and other gut-health related claims. A case related to probiotic claims was even brought to the European Ombudsman earlier this year.
The case rested on whether the term ‘probiotic’ was a health claim (as the EU attested) or a nutrition claim (as those bringing the case claimed).
The Ombudsman upheld the EU’s stance that it is a health claim, and that there is still not enough evidence of health benefits linked to probiotics to authorise it for use.
Another type of health claim that is often rejected is fibre. Of the 47 claims that have been brought to EFSA, only six have been authorised, explains Merten-Lentz.
Claims related to botanicals are something of an outlier. While included in the original list of health claims, the Commission has put a hold on more than 2,000 EFSA assessments of claims related to botanicals.
“This action was a direct result of EFSA’s inability to reconcile the nature of the evidence provided with the strict scientific requirements. The EC suspended evaluations to allow time for a consistent regulatory framework, which was never established,” Merten-Lentz explains.
“Therefore, EFSA’s suspension of systematic assessments continues to this day.”
Such claims can be used in specific instances, explains Squire Patton Boggs’ Ombredane. Under the transitional regime put in place for health claims still under evaluation, they can be used provided an application was submitted before January 19, 2008.
Has the legislation been changed recently?
The legislation has not undergone any recent changes, despite discussions to that effect.
A European Parliament resolution early last year proposed several changes to the regulation, including setting nutrient profiles to limit claims on unhealthy food; improving consumer information through tools such as front-of-pack labelling; assessing relevance of claims for nutrients that are rarely lacking in diets; and harmonising the use of botanicals in foods and supplements.
However, currently no action has been taken on this resolution, explains Merten-Lentz.
In the meantime, individual member states, such as Belgium, have clarified their position on whether ‘probiotic’ is a health or a nutrition claim, coming down on the side of the EU itself in saying that it is the former.
