According to the Food and Agricultural Organization (FAO) of the United Nations/World Health Organization (WHO) working group, probiotic microorganisms are “living microorganisms, which upon ingestion in adequate amounts exert health benefits beyond inherent general nutrition.”1 The group further defines that:
- A probiotic must be alive when administered
- A probiotic must have undergone controlled evaluation to document health benefits in the target host
- A probiotic must be a taxonomically defined microbe or combination of microbes (genus, species and strain level)
- A probiotic must be safe for its intended use.
It is striking that despite the vast amount of publications on probiotics and the increasing understanding of the complex role of the microbiota in the human body throughout the whole lifespan, the market has not recently seen disruptive innovations or blockbuster products.
The most commonly used probiotic genera are Lactobacilli and Bifidobacteria, especially Lactobacillus acidophilus and Bifidobacterium longum, or combinations thereof2. Products containing probiotics usually bear digestive and immune claims or are at least expected to positively affect digestive health and the immune system.
Discover and research probiotic ingredients for your food formulations
Prospector has listings for thousands of products from global suppliers. Find technical data, order samples and more now...
Countries with the largest number of product launches are the U.S., China, South Korea, Vietnam and Russia2. In 2015, China was by far the largest market in terms of volume, followed by the U.S., the EU (with the UK on top) and Japan with similar market sizes, and Brazil3.
A look at the development during recent years draws a more differentiated picture. Probiotics are on the rise in many non-EU countries, especially in China, Brazil and the U.S., were regulations are more liberal, or where the awareness of the health benefits of fermented foods and isolated live bacteria are popular wisdom. Different health care systems and a different culture of self-optimization may play a role as well.
Probiotic EU legislation
In contrast, probiotic manufacturers in the EU faced a tough couple of years with probiotic EU legislation. Declining market volumes and growth rates in probiotic food supplements and the probiotic yoghurt category in the EU clearly reflect the difficult regulatory environment for probiotics.
That is in part because—in the absence of harmonization—probiotics are subject to national provisions, resulting in a fragmented EU market place. At the moment, most EU countries consider the term “probiotic” a health claim, and some do not even allow such unspecific claims like “contains live bacteria”. The European Commission is discussing a probiotic EU legislation proposal that Italy filed in 2014 to classify “probiotics” as “generic descriptors”, but the outcome is unpredictable and timelines are not known.
Of the more than 400 health claim applications with probiotics, only one was authorized - an article 13.1 claim on lactose digestion for yoghurt or fermented milk that contains at least 108 CFU/g of the live starter microorganisms L. delbrueckii subsp. bulgaricus and Staphylococcus thermophiles. All other claim applications, e.g. on gut or immune function, were rejected. The most common reason for rejection was the insufficient demonstration of the claimed health effect.
Alternatively, probiotics are combined with vitamins or minerals that may bear a European Food Safety Authority (EFSA) health claim, e.g. on immune health. Some products are positioned with generic and soft claims that refer to a healthy lifestyle rather than a health benefit.
Foods for special medical purposes (FSMP), which do not fall under the claim regulation (EC) 1924/2006, may be an interesting option, at least in some cases. In the past, FSMP was sometimes a legal loophole for products that could not achieve a claim authorization. The new FSMP regulation (EC) 609/2013 closed most of these gaps. It remains to be seen how strictly the National Authorities will enforce Regulation (EC) 609/2013 with respect to probiotic formulas.
A key issue for these categories is the demonstration that a disease-related nutritional need for the specific ingredient exists and cannot be met by other foodstuffs, e.g. food supplements. Demarcation issues need to be carefully observed not to end up as medication. EFSA may be called to evaluate whether a product concept is suitable to meet the nutritional needs of the respective target patient groups.
Another alternative category is medical devices. For example, under the still valid regulation, probiotics were used in topical vaginal applications or tampons to alleviate bacterial dysbiosis, or in hard capsules containing probiotics (Class III) positioned for the regeneration of the mucosal function in the small intestine. Such applications are still possible during the transition period to the new medical device Regulation (EU) 2017/745.
The new regulation explicitly excludes viable biological material including live microorganisms. Medical devices with dead microorganisms might still be possible, but those do not meet the probiotic definition anymore.
- Despite the vast amount of evidence, health claims for probiotics are still very difficult to achieve, mainly because demonstrating low-level health effects in the healthy subjects as required by the Health Claim Regulation (EC) 1924/2006 is a serious challenge.
- Classifying probiotics as generic descriptor would certainly re-open the market for more generic products, but also bears the risk that differentiation might become more difficult.
- Under certain conditions, it is still possible to position probiotics as medical devices, but this possibility is not sustainable and will end in 2022.
- FSMP is an option if the requirements of (EC) 609/2013 are met. In cases of dissent, EFSA may be involved in the discussion whether a product qualifies as FSMP.
- Good science, thinking outside the box (e.g. about symbiotics), appropriate human studies, new forms of collaboration within the probiotic industry, political efforts, education of policy makers and consumers alike; trustworthy, realistic claims – and a lot of patience and passion are needed to succeed. One day, it will likely happen, even in the EU.
- Joint FAO/WHO Working Group Report on Drafting Guidelines for the Evaluation of Probiotics in Food. London, Ontario, Canada, April 30 and May 1, 2002
- Mintel, Ingredient Insight: Probiotics in VMS. May 2016
- Euromonitor for the International Probiotic Association, 2016
About the Author:
Dr. Steffi Dudek, since 2011 senior consultant at analyze & realize GmbH in Berlin, specialized in regulatory affairs with focus on novel food, additive and flavoring applications, FSMP and food supplements, regulatory strategy development. A biochemist by training,
Dudek has more than 20 years of experience in plant and dairy protein research and processing on academic and industrial scale.
The views, opinions and technical analyses presented here are those of the author, and are not necessarily those of UL, ULProspector.com or Knowledge.ULProspector.com. While the editors of this site make every effort to verify the accuracy of its content, we assume no responsibility for errors made by the author, editorial staff or any other contributor. All content is subject to copyright and may not be reproduced without prior authorization from Prospector.