The European market for probiotic dietary supplements is one of the most dynamic, but also one of the most complicated, areas of self‑care right now. Probiotics are hugely popular with consumers, widely used across Europe, and backed by an expanding body of science. But for companies trying to bring these products to market, one major obstacle remains: the European Union’s fragmented and highly restrictive regulatory environment. To help us unpack this, I’m joined on this episode of HBW Insight’s Over the Counter podcast by one of the leading experts on probiotics and the wider “biotics” category: David Pineda Ereño, managing director of DP International Consulting. In this first part of our conversation, we explore why the current international definition of “probiotic,” which currently includes the assertion that these microorganisms confer a health benefit on the host. It is this inbuilt health claim that has become such a regulatory sticking point in Europe. We discuss whether this definition could be revisited at the Codex Alimentarius level, and what that might mean for future harmonization. We also look at the growing divergence within the EU, as countries like Italy, Spain, Denmark and others move away from the European Commission’s restrictive position and allow the use of the term “probiotic” under certain conditions. Timestamps 2:00 – Introductions 4:30 – What are probiotics? 6:00 – Probiotic regulation in Europe 12:30 – Changing the definition 16:30 – The EFSA view 19:30 – EU member state divergence 22:15 – The Commission view 24:00 – What’s next? Guest Bio David Pineda Ereño is managing director of DPE International Consulting, an international consultancy firm that provides strategic and regulatory advice on the policy, regulation and trade of foods and food supplements. David has over 20 years of experience providing strategic solutions to companies, trade associations, and government bodies at national, regional, and international level, in Europe, Latin America, Asia, Middle East and Africa, and the United States.

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