By Joerg Gruenwald, analyze & realize ag09.07.17
The European vitamin and supplement market was worth €8.3 billion in 2015. Italy, Germany, and the U.K. are the top supplement markets in the EU. However, the German market is shrinking slightly, to the benefit of Italy and Eastern European markets. This is due to rapid market growth of the entire Eastern European market, projected to remain the fastest-growing territory until at least 2020. But why is the relatively mature Italian market so big?
The answer lies with the regulatory landscape in the EU. EU-wide legislation has the ultimate goal of harmonizing the national legislation at the EU level in order to ensure free trade across the union and easy access to all EU markets. EU regulations, therefore, are to be transferred to national law of the respective Member State unchanged, while directives may be adapted with some leeway.
While demands that the EU imposes on itself and its Member States for regulating as much as possible at the EU level are quite high, vital guidance from Brussels is missing in many places. An example is the missing upper limits for vitamins and minerals, which has been under discussion, both EU-wide and at a national level, for quite some time.
Another example is the use of substances other than vitamins and minerals, most notably of botanicals, for which no definite positive list for use in food supplements exists. And, of course, the burning question of health claims used on botanicals is yet to be resolved.
Finding Solutions
All these issues force the individual member states to find their own solutions, and Italy has been especially proficient. It has set its own list of upper limits for vitamins and minerals. It has been co-author of the BELFRIT list for plants to be used in food supplements that is currently being adopted into Italian law. And it has recently adopted a plant list with their respective health claims into national law, effectively circumventing the (lacking) guidance for botanical health claims and giving food business operators in Italy a firm basis on which to work.
In contrast, German food business operators find themselves unable to make health claims on botanical products; they operate in a regulatory limbo where the legal use of botanicals in food products is concerned, depending on court decisions to have clarity on whether or not a plant is a food plant, and they are forced to err on the side of caution when it comes to upper limits of vitamins and minerals because no legally binding upper limits have been set.
Recommendations of national authorities for vitamins and minerals are very low in some cases, so that many manufacturers feel that complying with these recommended upper levels would be a strong competitive disadvantage. No wonder, innovation in Germany is stalling, and the market is shrinking.
This is, of course, an oversimplification. However, the issues mentioned so far are not the only issues food business operators have with EU legislation, either. These, however, are not due to a lack of harmonization.
Italy is not the only market to have set its own upper limits for vitamins and minerals. Many other markets, among them Germany, are discussing national limits internally. Norway, Belgium, and The Netherlands are setting limits for certain nutrients.
The tendency clearly is toward a renewed fractioning of the EU marketplace in the health sector, which is the opposite of what the EU Commission set out to achieve. Clearly, the onus now is on Brussels to find solutions to these issues. The EU must establish harmonized and transparent regulations so that manufacturers are willing to invest in new product development to stimulate the European supplement market.
Joerg Gruenwald
analyze & realize ag
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.
The answer lies with the regulatory landscape in the EU. EU-wide legislation has the ultimate goal of harmonizing the national legislation at the EU level in order to ensure free trade across the union and easy access to all EU markets. EU regulations, therefore, are to be transferred to national law of the respective Member State unchanged, while directives may be adapted with some leeway.
While demands that the EU imposes on itself and its Member States for regulating as much as possible at the EU level are quite high, vital guidance from Brussels is missing in many places. An example is the missing upper limits for vitamins and minerals, which has been under discussion, both EU-wide and at a national level, for quite some time.
Another example is the use of substances other than vitamins and minerals, most notably of botanicals, for which no definite positive list for use in food supplements exists. And, of course, the burning question of health claims used on botanicals is yet to be resolved.
Finding Solutions
All these issues force the individual member states to find their own solutions, and Italy has been especially proficient. It has set its own list of upper limits for vitamins and minerals. It has been co-author of the BELFRIT list for plants to be used in food supplements that is currently being adopted into Italian law. And it has recently adopted a plant list with their respective health claims into national law, effectively circumventing the (lacking) guidance for botanical health claims and giving food business operators in Italy a firm basis on which to work.
In contrast, German food business operators find themselves unable to make health claims on botanical products; they operate in a regulatory limbo where the legal use of botanicals in food products is concerned, depending on court decisions to have clarity on whether or not a plant is a food plant, and they are forced to err on the side of caution when it comes to upper limits of vitamins and minerals because no legally binding upper limits have been set.
Recommendations of national authorities for vitamins and minerals are very low in some cases, so that many manufacturers feel that complying with these recommended upper levels would be a strong competitive disadvantage. No wonder, innovation in Germany is stalling, and the market is shrinking.
This is, of course, an oversimplification. However, the issues mentioned so far are not the only issues food business operators have with EU legislation, either. These, however, are not due to a lack of harmonization.
Italy is not the only market to have set its own upper limits for vitamins and minerals. Many other markets, among them Germany, are discussing national limits internally. Norway, Belgium, and The Netherlands are setting limits for certain nutrients.
The tendency clearly is toward a renewed fractioning of the EU marketplace in the health sector, which is the opposite of what the EU Commission set out to achieve. Clearly, the onus now is on Brussels to find solutions to these issues. The EU must establish harmonized and transparent regulations so that manufacturers are willing to invest in new product development to stimulate the European supplement market.
Joerg Gruenwald
analyze & realize ag
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.
