EU fairy tales: Is botanical harmonisation ‘a waste of time’?

By David Anderson

- Last updated on GMT

EU fairy tales: Is botanical harmonisation ‘a waste of time’?
The European Commission is 'wasting the time' of the botanical industry by trying to fix a 'fairy tale' problem of harmonising European rules, according to the author of a book which criticises EU health claims legislation.

Bert Schwitters, the author of Health Claims Censored, has hit out at a move by the European Commission to harmonise rules on the sale of botanicals across the EU.

The move to EU harmonisation comes amid a divergence between EU member states as to whether botanicals should be classified as medicines or foods and debate on the evidence required to prove their safety.

For instance, the UK, Nordics and Germany tend to classify botanical products as medicines.

But many botanical supplements can be purchased without a prescription from supermarkets and pharmacies, leading to safety concerns over the quality of the botanicals being sold.

EFSA has been accused of indecision on its handling of botanical assessments. It has rejected hundreds of botanical health claims and put thousands of claims on hold, some for as long as seven years, as it realised claim applications required more stringent proof of efficacy.

To offset this state of limbo, EU member states Belgium, France and Italy (BELFRIT) took matters into their own hands and proposed a list of around 1,000 approved botanicals for use in food supplements.

But last year the European Commissioner for Health and Food Safety, Vytenis Andriukaitis, announced a public consultation on the best way of dealing with botanical claims across the EU, hoping to end the state of limbo.

The consultation involving member states, stakeholders and small and medium enterprises (SMEs) will be followed by a report set to be published by the end of 2017.

However, Schwitters argues the consultation it’s not necessary, saying “there is nothing to harmonise”​ and that it is a waste of time.

Speaking to NutraIngredients, he said: “The problem that everyone is trying to solve is a fairy tale. There are sufficient safety rules through either the European or national level, which can be applied if there is a safety concern regarding some botanical.”

According to Schwitters, instead of a long-drawn out, bureaucratic consultation, the European Commission should propose an amendment to the current EU Nutrition Health Claims Regulations.

This amendment, he argues, would remedy the fundamental discrepancy in the botanical industry caused by a difference between the Medicinal Products directive and the EU Nutrition and Health Claims Regulation.

Currently, the Medicinal Products directive rules that manufactures don’t have to substantiate a product’s medical claim through clinical trials as long as they can demonstrate it has been in long-standing use, unlike the EU Nutrition and Health Claims Regulation, which does not permit such evidence.

Instead of wasting time and money on the consultation, one possible solution would be to amend the EU Nutrition and Health Claims Regulation, so that it will green light products which demonstrate long-standing use, he told us.

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