Overseas companies take risks over EU regulations
risking having their products removed from the market as they have
not gone through the correct regulatory channels, warns a
consultant to the natural products industry.
Dr John Wilkinson of Herbal Sciences Internationals told NutraIngredients.com the majority of US nutraceutical companies active in the European market have not gone through the novel foods process. He reached this conclusion after inspecting a range of products on the shelves of supermarkets and health food stores.
While some companies may be blasé about getting regulatory approval in the EU, others - in particular American companies - seem to be confused about the regulations and do not know which route they should go down.
Wilkinson said that, admittedly, the regulatory landscape in Europe is confusing; the most important directives for nutraceuticals are The Food Supplements Directive, The Novel Foods Directive, and the Traditional Herbal Medicine Products Directive.
Common to all three is the need for evidence of safety or history of use.
It is most crucial for companies entering the EU to gain novel foods approval, he said, and this forms a large part of Herbal Sciences' consultancy work.
Yet according to Wilkinson only a handful of companies have gone through the correct procedure. The majority are crossing their fingers, hoping that their products will not be noticed.
Wilkinson was not able to give examples of companies that are in non-compliance as that is confidential. But he did cite the example of noni juice as a material that was initially turned down for novel foods approval but has since been resubmitted and did recently gain approval.
While the head-in-the-sand approach may work in the short term since EU member states' surveillance teams are currently overloaded, "it is only a matter of time before a company is approached and then prohibited from selling their product, often immediately".
"Companies will be losing hundreds of thousands of their products, or have to pay huge costs for storage in the EU while the matter is resolved with the regulatory authorities."
Most companies don't need to be scared, he added. "It is frustrating that companies are wary of the directives and are putting their heads in the sand rather than tackling them head-on."
Wilkinson stressed that the directives exist to protect companies as well as consumers, acting as a screen against potential problems.
Compared with the uncertain costs of being found to be in non-compliance, there are fixed fees associated with gaining novel foods approval.
If an ingredient is found to be not novel, a letter will be issued to that effect, for which there is no fee; if a plant material is in the form of a different extract, a different part of the plant or is to be used in a different food matrix this would come under a substantial equivalence application, for which there is a US$3400 fee (€2850); if, however, it comes from a plant that has not been sold in the EU prior to 1997, when the Novel Foods Directive was introduced, a full application is needed, which costs in the region of $10,000 (€8400) and can take several years to complete.
Some advice on EU regulations is available for US companies through the major trade associations, which closely monitor legislation. Wilkinson agreed that this is helpful, if they receive useful information.
In addition, some European companies are failing to go through the appropriate channels, he said, but in general they tend to be more aware of the legislation.
For companies based in the US, time and cultural differences can make it tricky to deal with the regulatory authorities directly. "If information is presented in the wrong way it can be hard to turn that around."
