Botanicals in EU: what a challenge

Botanicals into the Food Regulation framework

The European Food regulation framework is vast. We all know that. However, the extreme vastness is not something strange if we think about the high number of aspects authorities have to consider when it comes to food or foodstuff to ensure consumers protection. Everything we consume must be assessed in the first place: Is it toxic? Can we eat or drink that? How much? How long? Can this be eaten with that? Can children have that? Quality of the production has to be check as well, during the production until our shelves: does the production complies with the standards to produce it? Does it have residues of pesticides? What about heavy metals? How should I keep this? Fridge? Room temperature? Which parameters should I check? How this lasts from a quality and a safety point of view in my pantry?

Let’s think about it. How many aspects have to be checked from the purchase of an additive to its use in the ready-to-eat slice of cake we eat? Many. Way too many. However, EU regulation is exceptionally built for all these aspects, and we have one of the best controlled and safe markets for food. The regulation does its best, and safety revision and scientific opinions try to protect consumers in a constantly increasing sector due to the new technologies. Legislation cannot always keep up with the rate of changing the latest production processes, showing up some “grey area“—Grey areas which, for several reasons, are not harmonised.

Botanicals are one of them.

Botanicals are described as a substance obtained from a plant and typically used in medicinal or cosmetic products. Those are chemicals or mixture in the food sector -mainly- used in food supplements or nutraceuticals. The EU regulation has not already defined a harmonised list of botanicals admissible into the market: the food supplement procedure is a national procedure; therefore, each Member State can allow botanicals in its territory after an internal safety evaluation. A specific provision seems not justified and, from a regulatory perspective, botanicals are covered by the existing legislation following:

• Regulation (EC) 178/2002
• Directive 2002/46/EC on food supplement
• Article 8 of Regulation (EC) 1925/2006 on the addition of vitamins and minerals and certain other substances to food
• Regulation (EC) 2015/2283 concerning novel food and novel food ingredients*
• National laws and principle of mutual recognition

*If a botanical is considered a Novel Food, only, in this case, it enters the Union List of Novel food -after registration process- with the intended use of food supplement, and it applies all over Europe.

Since the challenge given by heterogeneity of this class of compounds, in 2011, the Belgian, French and Italian authorities, each assisted by a renowned scientific expert, have decided to develop a common approach for evaluating botanicals, the BELFRIT’ project. The BELFRIT project elaborates the known as BELFRIT list, which reports the plant allowed to be used as raw material for food supplement preparation. The creation of the list aims to simplify the procedure for the national authorities in the food supplement area. It is not a legally binding instrument and cannot be opposed to legal provisions, including those of the Member States involved in the project. Still, it remains a valuable tool in assisting the food business operator in such an area.