Opportunities and confusion: The evolving regulations for probiotics in Europe

By Nikki Hancocks contact

- Last updated on GMT

Getty |  MarianVejcik
Getty | MarianVejcik

Related tags: Regulation, Probiotics, Prebiotics, Brexit

There's an opportunity for UK companies to lead on innovation in the gut health space following Brexit and there’s hope for a less rigid regulatory landscape across Europe in the future.

These were some of the opinions provided during day one of NI's Probiota Digital Summit which aired yesterday (February 9th).

The event, which is available now on on-demand, was the first in the three-day event which continues today and tomorrow (register here​).

Dr Luis Gosalbez, from the consultancy Sandwalk BioVentures, explained the current legislative landscape for pro/prebiotics across Europe in light of Spain’s recent change in legislation to allow for ‘probiotics’ on labels​.

In a recent Sandwalk BioVentures survey of 46 competent food safety authorities in the EU, the company found that despite EFSA not allowing use of the terms pro- or prebiotics, 22% of EU member states allow the term probiotic and 33% allow the term prebiotic.

He said the number of members states choosing to go against EFSA opinion is increasing, backed by the principal of mutual recognition which states that goods legally sold in one EEA country can be marketed and sold in any other.

Livia Menichetti, from EHPM, said if member states continue to make their own regulations nationally then the industry may soon see legislative change on a European level because the lack of harmonisation is causing issues concerning for the internal market.

Dr Gosalbez pointed out there is good news for those marketing chicory inulin products because on Jan 1st​ 2016 EFSA agreed to allow the health claim – “contributes to maintenance of normal defecation”. That decision only applied to the health claim applicant for the first five years so as of Jan 1st​ this year all companies using chicory inulin can now use that health claim.

Discussing Brexit, Brian Kelly, partner at the law practice Covington & Burling, gave his expert thoughts on how it might influence the market going forward.

He said: "For now, the country directs applicants to EFSA... but my hope is that there will be greater flexibility on how that framework is applied and it won’t be as rigid. The UK is looking for easy post-Brexit wins so there may be an opportunity to put in a case to allow use of the term probiotic/prebiotic.

“There’s real opportunity for companies in the UK to be innovative in a way that you just can't on a European level because your hands are lied through needing to pay attention to the rules and attitudes of the 27 member states."





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