Lithuania has sent a list of 182 botanicals it intends to ban in food supplements to the European Commission in a move one major supplier called “a step back” for EU harmonisation and free trade.
While many of the herbs on the negative list are obscure or toxic (like hemlock) and will spark few protests, it includes more popular herbs like St John’s wort (Hypericum perforatum) and Indian ginseng (Withania somnifera) that the Baltic nation may be forced to permit under EU mutual recognition obligations.
“Most of the plants on the negative list are logical inclusions as they cover plants that are toxic and should not be used in food supplements,” said Patrick Coppens, director of scientific and regulatory affairs at Brussels-based industry group, Food Supplements Europe (FSE).
“These are also banned in many other member states. However the reasons for the inclusion of a number of plants in the list are not clear. Some of these plants are widely used in food supplements today and should therefore not be banned without clear safety-based reasons.”
The world’s biggest herbal players – Indena in Italy and Naturex in France – criticised Lithuania’s action.
“We believe this negative list makes a step back in harmonisation and free trade in the European Union as it includes plants that are already widely used in food supplements in other EU countries,” said Indena marketing director, Christian Artaria. He said this was the case regardless of whether the extracts ended up in food supplements or pharmaceutical products as API (active pharmaceutical ingredients).
Artaria added that European Court of Justice (ECJ) rulings showed that, “it should not be the ingredient used to classify a product as a supplement or a drug, but the way the finished product, with all its characteristics, is presented to the market.”
Elizabeth Bui, Naturex’s nutrition and health director, warned the bans would only encourage purchases online for desired products.
“At a time when online purchasing represents a significant distribution channel for food supplements, this ban will likely push consumers to buy online and escape from local health authority vigilance,” she said.
“…Countries like Belgium, France and Italy have taken steps to clarify the situation, harmonising the list of products authorised and enabling consumers to better understand the dietary supplement market.”
Mutual recognition – will it be recognised?
Coppens predicted mutual recognition would force Lithuania’s hand in regard to St John’s wort, Indian ginseng and others on the list like Horse chestnut (Aesculus hippocastanum), Earth smoke (Fumaria officinalis), Red stinkwood (Prunus Africana), Centella (Centella asiatica), Chasteberry (Vitex agnus-castus) and European mistletoe (Viscum album).
“If a member state wants to restrict a product lawfully marketed in another member state, the burden of proof that there is a safety issue with that product is upon the member state."
“This must be the result of a risk assessment.”
He added: “The Commission will in any case insist mutual recognition is explicitly mentioned in the legislation accompanying the list.”
Mutual recognition is an EU principal that means, in theory, if a product is approved for sale in one EU member state, other member states shall also permit it.
But in practice it does not always function like that, something that provoked Belgium, France and Italy (BELFRIT ) to work on a combined positive list of about 1000 botanicals that was passed into Italian law recently and appears set to become some kind of reference across the 28-nation EU bloc.
The full Lithuanian list is here: