By Joerg Gruenwald, analyze & realize ag04.08.21
With the introduction of the Nutrition and Health Claims Regulation (NHCR), the probiotics and prebiotic industry in particular faced various challenges. Since the European Commission classified the terms probiotic and prebiotic as health claims, they require authorization in order to be used, which has not been granted even following dozens of applications. Thus, the use of these terms on labels was banned.
This put the EU market at a severe disadvantage. While everywhere else, probiotics and prebiotics increased in sales as consumers educated themselves—and food business operators (FBOs) could state the health benefits openly on the labels—EU FBOs of formerly successful brands saw their sales stagnate or even contract.
This is especially grating in current times, when immune system support is very much in demand. After all, even though EU FBOs are not allowed to say it on the label, the body of evidence for the immune benefits of probiotics and prebiotics via gut microbiome modulation is excellent.
But it is not only immune health that probiotics have benefits for. Evidence in the weight management space is also growing. Consumers have made the connection between being overweight and severe COVID-19 as well. According to data from Lumina Intelligence, online engagement in the form of reviews left with probiotic products making weight management claims (e.g., by modulating the gut microbiome) has increased by over 500%.
A Different Regulatory Interpretation
While most EU member states followed, and are still following, the EC position, some countries would not accept the imposed limitations of the “probiotic ban” and have implemented their own regulatory interpretation; and more countries are doing the same.
In Italy, for instance, the term “probiotic” is not considered a health claim. Instead, it is defined as a condition of use, removing it from the scope of the NHCR. Last year, Spain provided a legal argument in favor of using the term probiotic, which could be decisive for the future, namely the principle of mutual recognition. Mutual recognition is a mechanism that allows free movement of goods within the European Single Market; once a product has been lawfully marketed in one member state, it cannot legally be prevented from being marketed in all others.
The Domino Effect
This move by Spain drew more attention to the problem among member states and triggered something of a domino effect. Recently, the Danish Minister for Food, Agriculture and Fisheries announced that Denmark will once again take the initiative and ask the EU Commission to find a solution for the labeling of probiotics. Denmark had approached the EU Commission several times in the past with this concern. In the coming months, Denmark also wants to negotiate with the authorities of other EU member states about possible changes to the rules at the EU level.
The main point of discussion in Denmark was also the application of the principle of mutual recognition. The reasoning is that Danish consumers, knowledgeable about the benefits, are “forced” to import probiotic products from countries that have their own legislation regarding the probiotic labeling issue (via e-commerce), while Danish manufacturers that comply with EU regulations are disadvantaged in the physical world.
Moreover, according to a survey conducted by Sandwalk BioVentures, Greece, Malta, Poland, the Czech Republic, and Bulgaria apparently also changed their opinion regarding the use of probiotics on food supplement labels. This would mean that 30% of EU countries have accepted the term “probiotic” on product labels.
E-Commerce Levels the Playing Field
In fact, e-commerce has changed the way labeling legislation is being looked at in general. If consumers can and do legally buy products via websites from countries that allow the term and other health claims that are not allowed in their home countries, then Europe cannot sensibly disregard this inequality and should make efforts to level the playing field.
Let us recall that the NHCR has come into effect in order to protect the consumer from fraud or from being misled. This is a good thing. However, the risk, both of being misled as to health benefits and of being harmed by an unsafe product, is very low when it comes to probiotics. Wanting to protect the consumer from proven health benefits evidently makes no sense.
It remains to be seen whether the EU Commission will recognize all that and adjust its legislation accordingly. In the meantime, FBOs in the probiotic space will have to observe local requirements, ideally with the help of experienced consultancies such as analyze & realize GmbH.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com; Website: www.analyze-realize.com.
This put the EU market at a severe disadvantage. While everywhere else, probiotics and prebiotics increased in sales as consumers educated themselves—and food business operators (FBOs) could state the health benefits openly on the labels—EU FBOs of formerly successful brands saw their sales stagnate or even contract.
This is especially grating in current times, when immune system support is very much in demand. After all, even though EU FBOs are not allowed to say it on the label, the body of evidence for the immune benefits of probiotics and prebiotics via gut microbiome modulation is excellent.
But it is not only immune health that probiotics have benefits for. Evidence in the weight management space is also growing. Consumers have made the connection between being overweight and severe COVID-19 as well. According to data from Lumina Intelligence, online engagement in the form of reviews left with probiotic products making weight management claims (e.g., by modulating the gut microbiome) has increased by over 500%.
A Different Regulatory Interpretation
While most EU member states followed, and are still following, the EC position, some countries would not accept the imposed limitations of the “probiotic ban” and have implemented their own regulatory interpretation; and more countries are doing the same.
In Italy, for instance, the term “probiotic” is not considered a health claim. Instead, it is defined as a condition of use, removing it from the scope of the NHCR. Last year, Spain provided a legal argument in favor of using the term probiotic, which could be decisive for the future, namely the principle of mutual recognition. Mutual recognition is a mechanism that allows free movement of goods within the European Single Market; once a product has been lawfully marketed in one member state, it cannot legally be prevented from being marketed in all others.
The Domino Effect
This move by Spain drew more attention to the problem among member states and triggered something of a domino effect. Recently, the Danish Minister for Food, Agriculture and Fisheries announced that Denmark will once again take the initiative and ask the EU Commission to find a solution for the labeling of probiotics. Denmark had approached the EU Commission several times in the past with this concern. In the coming months, Denmark also wants to negotiate with the authorities of other EU member states about possible changes to the rules at the EU level.
The main point of discussion in Denmark was also the application of the principle of mutual recognition. The reasoning is that Danish consumers, knowledgeable about the benefits, are “forced” to import probiotic products from countries that have their own legislation regarding the probiotic labeling issue (via e-commerce), while Danish manufacturers that comply with EU regulations are disadvantaged in the physical world.
Moreover, according to a survey conducted by Sandwalk BioVentures, Greece, Malta, Poland, the Czech Republic, and Bulgaria apparently also changed their opinion regarding the use of probiotics on food supplement labels. This would mean that 30% of EU countries have accepted the term “probiotic” on product labels.
E-Commerce Levels the Playing Field
In fact, e-commerce has changed the way labeling legislation is being looked at in general. If consumers can and do legally buy products via websites from countries that allow the term and other health claims that are not allowed in their home countries, then Europe cannot sensibly disregard this inequality and should make efforts to level the playing field.
Let us recall that the NHCR has come into effect in order to protect the consumer from fraud or from being misled. This is a good thing. However, the risk, both of being misled as to health benefits and of being harmed by an unsafe product, is very low when it comes to probiotics. Wanting to protect the consumer from proven health benefits evidently makes no sense.
It remains to be seen whether the EU Commission will recognize all that and adjust its legislation accordingly. In the meantime, FBOs in the probiotic space will have to observe local requirements, ideally with the help of experienced consultancies such as analyze & realize GmbH.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com; Website: www.analyze-realize.com.
