“Probiotic” Restricted on Food Labels in the EU

The term “probiotic” will no longer appear on food labels in many European Union (EU) countries starting December 14, 2012. With the exception of yogurt cultures improving lactose digestion in lactose intolerant people, no probiotic claims have been approved in the EU. There are many confounding factors contributing to this state of affairs: lack of clear direction on what research is required (Guarner et al. 2011; Sanders, et al. 2011), exclusion of well-conducted studies because they used patient (not healthy) populations or disease outcomes, difficulty in defining physiological benefits with healthy study subjects, and existence of studies that do not substantiate the physiological benefit (i.e., null studies). Some believe that the standard of evidence required by EU authorities is unrealistic for foods. However, as regulatory expectations become clearer and as assessors become more knowledgeable, I expect that specific probiotic claims are likely to be approved in the EU. Nonetheless, until this time, even the word “probiotic” will be restricted in most of the EU. A probiotic is a live microorganism, which when administered in adequate amounts, confers a health benefit on the host (WHO/FAO, 2001; Sanders, 2009). If you accept this definition of a probiotic, then it is internally logical that only microbes with proven health benefits should be able to be called “probiotic.” However, there is little doubt about the physiological effects of many probiotics, which leads one to consider if in fact adequate quantities of live microbes of certain well-tested genera and species – even in the absence of human studies on specific strains – should at least be allowed to be called “probiotic.”  More specific claims would require more convincing evidence.

Guarner F, Sanders ME, Gibson G, Klaenhammer T, Cabana M, Scott K, et al. Probiotic and prebiotic claims in Europe: seeking a clear roadmap. Br J Nutr. 2011:1-3. Epub 2011/07/09.

Sanders ME, Heimbach JT, Pot B, Tancredi DJ, Lenoir-Wijnkoop I, Lahteenmaki-Uutela A, et al. Health claims substantiation for probiotic and prebiotic products. Gut Microbes. 2011;2(3):127-33.

WHO/FAO (World Health Organization and Food and Agricultural Organization of the United Nations). Health and Nutritional Properties of Probiotics in Food including Powder Milk with Live Lactic Acid Bacteria. 2001.

Sanders ME. How do we know when something called “probiotic” is really a probiotic? A Guideline for consumers and health care professionals. Functional Food Rev. 2009;1:3-12.