Minnesota-based ingredients supplier Biothera is celebrating after the European Food Safety Authority (EFSA) declared the company’s immune system-boosting Wellmune WGP yeast beta glucan to be safe for human consumption.
EFSA’s decision means that, for Biothera, the long process of gaining approval to market food and beverage products containing Wellmune under the EU’s Novel Food Regulation is drawing to a close, nearly two years after it began.
All that remains now is for the European Commission to rubber stamp EFSA’s opinion – something that is expected to take place before the year is out. Biothera was obliged to seek novel food approval for Wellmune because there was no history of consumption of yeast beta glucan in the EU prior to 15 May 1997.
Gaining novel food approval for an ingredient in the EU is somewhat more complicated than obtaining the equivalent Generally Recognized As Safe (GRAS) status in the US.
With GRAS, companies are required by law simply to self-affirm the safety of their product in consultation with a single government body. In the EU, companies must submit a comprehensive safety dossier that will be scrutinized individually by the governments of all 27 EU member states, as well as centrally by EFSA, the European Parliament and the European Commission.
Novel Food process was generally smooth
Nonetheless Don Cox, senior vice president of R&D at Biothera, says that the company found the process of gaining approval in the EU to be a generally smooth one. He puts this largely down to the fact the company hired a specialist third party consultancy – Cantox Health Sciences International – to hand-hold it through the process. For all but the largest multinational businesses, this is an essential step, he insists.
“Of course, there are certain large food companies around the globe that probably have their own regulatory group that can be an expert in every geography,” he explains. “But sitting over here in the United States it’s very difficult to be an expert in the regulatory affairs of every other geography. So we worked with and through Cantox, who guided us really well. They helped us structure everything.”
Having hired Cantox, Biothera’s next move was to decide with which EU member state the novel food submission for Wellmune should be lodged. Cantox recommended Ireland, a decision based both on the common language, which would make the submission easier to compile, and on the fact that the workload of the Food Safety Authority of Ireland at the time was not too onerous.
It was a good advice. Biothera’s dossier was submitted on 23 September 2009 and by 23 December 2009 Ireland had already forwarded its initial assessment to the European Commission, declaring that it believed Wellmune to be safe.
This wasn’t the end of the story, however. On 10 January 2010 the European Commission sent Ireland’s initial assessment to all 27 EU member states, giving each of them the opportunity to ask their own questions and raise any concerns. Several did so, but Cox says the company was able to address these “relatively easily."
Fresh research was key
This, he argues, was possible only because of the way Biothera continually invests in fresh research into toxicology. Among these issues raised by member states, for example, was the impact of Wellmune on numbers of cytokines – messengers in the body that help immune cells communicate with each other.
Cox says: “We had just completed a human study in the UK, and we were able to present them with data on 100 subjects showing that there was no cytokine generation due to Wellmune. That study helped us to provide the information the working group wanted to see.
“Over the years we’ve always continued to do safety studies, in humans and animals, and I think that helped us have a relatively smooth experience. We didn’t just stop and say: ‘here’s our package of safety information’. We continued, and will continue, to generate safety information as we progress forward.”
With novel food approval for Wellmune almost in the bag, Biothera’s attention is already turning to gaining an approved Article 13.5 health claim for the ingredient under the EU’s Nutrition & Health Claims regulation. Cox says: “We’ve studied the process and what EFSA is requiring for a claim. We’ve done some of that work already and this year we’ll execute a couple of additional studies.”
Biothera’s experience illustrates how Europe’s regulatory road is long and sometimes daunting. But it also shows that with the right partner, and a carefully targeted research program, whatever hurdles are put in your way can be surmounted.
You can view EFSA’s full report on Wellmune here.