Marketing botanicals in the EU – what are the pitfalls?

Posted 25 February, 2017

The marketing of botanicals in the EU remains complex, and harmonisation between Member States has proven difficult. Over 50 participants from the European Food Industry, Legal affairs and Clinical research companies joined the interactive 5th international workshop on food supplements and botanical extract claims to learn how to market botanicals in the EU.


The complexity of marketing botanicals in the EU

Botanicals can be marketed in the EU as food supplements or as Traditional Herbal Medicinal Products (THMPD) depending on the composition, presentation and claimed effect. Under current EU rules it is possible to classify the same botanical as a food or as a medicine which leads to discrepancies between the various European countries and causes confusion among food business operators and consumers. The creation of the BELFRIT list of around 1,000 botanicals which Belgium, France and Italy considers safe for use in food supplements was a positive step towards harmonisation of botanicals in the EU.

However, there is still a long way to go since several countries such as the UK, Germany and the Nordic countries remain resistant and consider many plants that are included in the BELFRIT list to be medicinal.

Additionally, the evaluation of around 2,000 botanical health claims have been put on-hold following 500 negative opinions from the European Food Safety Authority (EFSA). Claims “on-hold” may still be used while they are under consideration, provided they comply with the general principles of the Nutrition & Health Claims Regulation 1924/2006, whereby claims are scientifically substantiated, follow the national provisions of the Member State where the claim is used, and are not misleading or do not suggest any medicinal properties as these are not permitted. In the mean time, the European Commission is evaluating whether or not the Nutrition and Health Claim Regulation (EC) No 1924/2006 should be updated, taking into account reflections regarding the use of plants and their preparations in foods.

Flexibility of botanical claim wording

Some on-hold claims are clearly medicinal claims and can thus not be used. Botanical claims are a complex issue so it may be wise to play it safe and stick to standard wording such as “evening primrose contributes to the maintenance of normal blood pressure” or “ginseng contributes to cognitive function”. Certain flexibility and creatibity is permitted, provided that a claim does not insinuate stronger or exaggerated effects. For example, instead of using  “contribute to” one could use “support, play a role, intervene, etc.” since they are rather neutral words. On the other hand, words such as “improve, helps to stimulate/activate, are necessary for” may suggest a positive or amplified effect. Similarly, “normal” can be replaced by terms such as “good” or “healthy” as long as it is clear that the good/healthy condition is maintained and not improved. Hence, instead of saying an ingredient contributes to the maintenance of “normal skin” it can also contribute to the maintenance of “healthy skin” since healthy skin is the normal standard and does not necessarily suggest any potential improvement. In other words, it is crucial that the overall meaning or scope of a claim does not suggest a medicinal property or improved health effect.

Workshop highlights

The morning session focused on a review of the current situation of botanical extracts and supplements with regards to their legal classification, novelty and health claims as well as the potential impact that BREXIT could have on these products. The afternoon session focussed on practical topics where speakers gave tips on substantiating health claims, explained the link between trademarks and claims, and provided insight on the interpretation of the definition of “dietary management” of medical foods. Pen & Tec was represented by Ms Liza Van den Eede who delivered a presentation on which steps should be taken to smoothly authorise novel foods in the EU.

The various breaks during the workshop offered an excellent networking opportunity for the the delegates and provided an opportunity to meet the experts of the food industry.

Next steps?

  • Will there be a 6th International Workshop? If so when & where?
  • What’s next for the “on-hold” botanicals?
  • Do EFSA plan on reviewing anything? Any changes to legislation planned?
  • Implications of Member States not recognising the BELFRIT list? Any further plans for harmonisation?

Pen & Tec are well placed to help you market botanicals in the EU. Please contact a member of our team if you would like any further information.