Can you make wellness claims on botanicals (Case C-386/23)?
Botanical based health claims have been a headache for regulators and business alike. Their similarity in many ways to traditional herbal medicines have resulted in a list of almost 1500 claims being placed on-hold until the European Commission can make a decision on how they should be assessed (e.g., what data, RCT vs. Traditional history of use or some other combination).
In the interim such claims can continue to be used based on national provisions for the assessment of claims pre the health claims regulation coming into force.
One issue that has been of debate is can we make a general non-specific claim based on the use of a botanical. The difference between a general non-specific and specific claim is that the latter is scientifically verifiable based on a causal relationship between a food or its constituent and the function of the human organism (health).
In this case claims such as ‘mood enhancing’ and ‘improvement of emotional balance’ where viewed by the German Regional courts as non-specific claims as argued in the injunction for use of such claims by a consumer association (VSW) who’s aim is to maintain fair competition. The legal concern was that to make general health claims they must be accompanied by (next to or linked) to a claim on the Article 13 or 14 list. Because of the on-hold status it could be argued such claims are not on these lists and therefore precludes use of general health claims based on on-hold substances (in this case saffron and melon juice). The defendant (Novel Nutriology T/A O’Gaenics®) brought an appeal on the point of law that such general claims can be used.
Source: www.ogaenics.com
The question before the court can be split into 2 parts:
Can general health claims be made on botanicals without those claims been authorised under that regulation and included in the list of authorised 13/14 claims?
OR without being accompanied by a specific health claim contained in one of those lists pending completion by the authority and commission?
A number of challenges regarding botanicals and the lack of action by the commission have been raised at the CJEU but so far none have resulted in the Commission resolving the on-hold debacle. This latest example could have a number of wider implications for food business if for example general wellness type claims cannot be used when products include botanical substances.