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

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.

Related News

Indena and Hyris partner on portable genomic identification of botanicals

Indena and Hyris partner on portable genomic identification of botanicals


Has the EU Commission given up on defending the market of botanicals?

A final report on the botanical blockade will be published by the end of 2017 and 'reflections of next steps' will come at the beginning of 2018, the Commission has confirmed. ©Stock/marilyna

Botanicals progress: EU Health Commissioner promises solution in his time

30-50% of food e-commerce businesses in Sweden are not registered. ©iStock/scyther5

Sweden to create special supplement e-commerce task force

The EU's botanical health claim situation is slowly moving to resolution. ©iStock

EU herbals: Creative escape routes out of botanical claims limbo-land

The Horn File: 'Protecting consumers and creating a workable regulatory framework for the SMEs, such as my own, which make up the majority of our sector are not mutually exclusive goals.' ©iStock

New EHPM chair promises botanicals progress at ‘crucial point for our industry’

EFSA's interactive database on botanicals 'broadens the possibilities', says consultant. © / AlexRaths

EFSA adds botanicals to interactive data warehouse

The head of the Commission's DG SANTE food legislation unit outlines three possible solutions to the EU's botanical woes. © / JPC-PROD

The botanical blockade: EC ponders 3 pathways

Related Products

See more related products

Submit a comment

Your comment has been saved

Post a comment

Please note that any information that you supply is protected by our Privacy and Cookie Policy. Access to all documents and request for further information are available to all users at no costs, In order to provide you with this free service, William Reed Business Media SAS does share your information with companies that have content on this site. When you access a document or request further information from this site, your information maybe shared with the owners of that document or information.