The study, part of the €6m European Union-funded PlantLIBRA research project, was conducted across six EU nations and involved 2359 people, 1288 different products and 491 individual botanicals and extracts.
The researchers, led by Alicia Garcia-Alvarez from the University of Barcelona, polled PFS usage in Finland, Germany, Italy, Romania, Spain and the UK.
“The results of the survey highlight clear differences between countries in terms of the botanicals used by consumers as PFS,” the researchers wrote.
“This may reflect the fact that the current legal and regulatory framework for botanicals has a major influence on the nature of the local PFS markets.”
In the EU, about 1500 botanical health claim submissions are on hold under the nutrition and health claims regulation (NHCR), and botanicals are not formally part of the 2002 EU Food Supplements Directive either.
“Current legislation varies across Europe, with significant differences in the botanical species permitted in PFS.”
This was highlighted by the manner in which the same botanical could be classified as a food in some countries and a medicine in others, and in others fall under the EU Traditional Herbal Medicinal Products Directive (THMPD).
Luca Bucchini, PhD, managing director of Rome-based Hylobates Consulting and member of the PlantLIBRA consortium that includes botanical giants like Naturex and Indena, called the research a “landmark study”.
"This is a landmark study,” Bucchini said. “One in five Europeans take plant food supplements every year, at least to some extent, and yet this is the first harmonised cross-country survey in Europe.”
“Consumption data are needed for proper risk assessment and policy-making, and the study starts to fill this gap.”
“For example, within the same project PlantLIBRA, researchers at Finland's Food Safety Agency (EVIRA) are already linking the consumption data to a composition database to estimate intake of various compounds - for risk and for benefit assessment."
He added: "This is an amazingly diverse and lively market, with hundreds of plants in use. It is a scientific and regulatory challenge as we expect 21st century information and control on these products. Yet, this diversity - of plants and products - should be preserved."
"One may be surprised that valerian, a popular supplement in most countries, is on sale only as a medicine in Germany, and that for none of these botanicals, at least for use in supplements, there is no risk assessment, no uniform standards, and no European regulation."
PFS case study in complexity
“...in Germany, food supplements are regulated by the German Regulation on Food Supplement and the German Law on Food and Feed.
“Positive lists are available for minerals and vitamins. Food supplements have to be registered with the Federal Office of Consumer Protection and Food Safety . The BVL maintains a list of plants which are either classified as a food or a medicinal product, and which is neither considered complete nor legally binding. Data on the intake of PFS in Germany is limited and, despite food supplement intake being recorded in recent health and nutrition surveys, no specific data was published on PFS intake.
“The results from the PlantLIBRA consumer survey do not include Valeriana officinalis in the German top list of botanicals used in PFS, whereas 1852 medicinal products containing Valerian exist on the market. The absence of Valeriana officinalis in the German list of botanicals can be explained by its dominant presence as a HMP [herbal medicinal product] in the German market.”
In calling for further national surveys, the researchers noted the limitations of their work.
“The sample population comprises exclusively of PFS consumers, recruited to meet very specific inclusion criteria and hence no comparisons can be made with the general population. Future studies should seek to compare users and non-users of PFS.”
9(3): e92265. doi:10.1371/journal.pone.0092265 (see page 14 for breakdown of the top 40 herbals in the 6 countries)
‘Usage of Plant Food Supplements across Six European Countries: Findings from the PlantLIBRA Consumer Survey’
Authors: Garcia-Alvarez A, Egan B, de Klein S, Dima L, Maggi FM, et al.