EU health claims and botanicals: Back in the spotlight amid COVID-19 crisis

While consumers frightened by the COVID-19 pandemic stocked-pilled food (and toilet paper), it was tempting for some companies to overpromote their products with regards to their ability to ‘treat’ or ‘cure’ the disease. This was especially the case for products that may sound ‘natural’, like plant derived products. 

Recently several national authorities recalled the basic principle that claims must not be false, ambiguous or misleading for the consumer nor attribute a property of treating or curing a human disease. This was for instance the case in Belgium where the FASFC seized a tea from China that was labeled as "product for the treatment of flu, to fight the coronavirus​” and encouraged the consumer to be extra-vigilant regarding this kind of so-called ‘miracle’ product.

This is not the first time that a product derived from a plant has draw attention with non-authorized claims. While not always that extreme, claims surrounding botanical products are often problematic in the EU.

Current context surrounding claims referring to botanicals

There is no clear legal definition of “botanicals”, but this term often designates “a substance, used either as a food or a medicine, derived from plants, fungi, algae or lichen​”.

Botanicals are subject to a wide variety of claims that promote their health benefits. When made on foods to be delivered as such to the final consumer, such claims should be made in accordance with Regulation (EC) n°1924/2006, which applies to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising (the NHC Regulation).

If the NHC Regulation offers some flexibility in the use of statements which refer to general benefits and in the choice of wording, often claims associated with botanicals are flexed to the point that it may trigger the reclassification of the product.

The boarder between botanical food products and medicinal products, in particular traditional herbal medicinal products, is very thin. The choice of claims that accompany such products is consequently of particular importance.

Nowadays, there are only few authorized health claims for botanicals such as “Monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol levels​”, while hundreds have been rejected and the assessment of more than 1,500 has been put “on hold” by the European Commission.

The NHC Regulation provides that health claims must be authorized following a strict scientific assessment by the European Food Safety Agency (EFSA). But following the adoption of the NHC Regulation the Commission received thousands of applications that have been consolidated in a list of 4637 health claims to be examined by EFSA.

When EFSA started to carry out its scientific assessment, the first 500 opinions issued were negative, as most of the claims failed to demonstrate the cause and effect relationship between the consumption of the botanical substance and the alleged health benefit. This resulted in the Commission decision to request the EFSA to suspend temporarily its assessment of the health claims relating to botanical substances.

In 2012, the European Commission published a list of 2000 claims for which the scientific assessment has been put “on hold” and which could therefore continue to be used in accordance with the transitional scheme provided for in Article 28(5) and (6) of the NHC Regulation. To this date, despite several challenges before the Court of Justice regarding the legality of such an extended transition period, most of the claims referring to botanicals remain on hold and thus can be used only if they comply with the other provisions of the NHC Regulation and possible national legislations. 

Is the legal framework still fit for purpose?

As the assessment of health claims on plants and their preparations are currently on hold, and that part of the NHC Regulation has not been fully implemented, the European Commission launched in 2015 its REFIT evaluation focusing on nutrient profiles and health claims on plants and their preparations added to foods.

As part of the REFIT, a study was commissioned. One aspect of this study was whether the scientific assessment of health claims related to botanicals could recognize the notion of “traditional use” as an adequate element for their substantiation.

A key element for the REFIT evaluation was to take into consideration the broader regulatory framework that applies to plants and their preparations when used in food and in particular the possible overlap between the NHC Regulation and the THMP Directive 2004/24/EC.

Interestingly, the REFIT Platform recommended in its opinion to wait for the results of the REFIT of the NHCR before deciding on whether there is a need to collect additional evidence on the performance of the THMP Directive 2004/24/EC and whether on this basis, an amendment of the latter is needed.

To date the outcome of the REFIT evaluation for the NHC Regulation has not been made public.  Based on the work program of the European Commission for 2020, there is still hope to finally see the long awaited report finally published. Nevertheless, given the current Coronavirus crisis, the publication might be postponed along with the presentation of the “farm to fork strategy” Strategy which should put the spotlight on consumer information.

To be closely followed….