Recently, various botanical preparations derived from traditional ayurvedic medicine have seen increased use as health-promoting ingredients in food supplements. However, the mere fact that these botanicals are of natural origin does not guarantee their safety as they might contain harmful substances. The number of reports indicating negative health effects and unfavorable scientific findings is rising, so botanical preparations are coming under increasing scrutiny. As a result, more and more of these preparations are being added to the list of substances prohibited, restricted, or scrutinized. Green tea catechins serve as an example of substances that have recently been added to Annex III of the Fortification Regulation as the EU Commission is actively utilizing Article 8 of Regulation No. 1925/2006 to limit the use of certain substances.
Highly purified curcumin extracts under further scrutiny
Last year, the French Agency for Food, Environment and Occupational Safety (ANSES) expressed significant concerns regarding the use of turmeric extracts. This was due to a rise in cases linking the consumption of food supplements containing curcumin to adverse liver effects, which were recorded in the French nutrivigilance system. For more information please refer to our newsletter article about curcumin supplements under scrutiny. Against this background, the Italian Ministry of Health issued a call for data demonstrating the history of consumption of highly purified curcuma extracts. However, the evidence provided failed to substantiate a significant consumption of Curcuma longa extracts containing 95% curcumin prior to 1997. As a result, the Ministry is consulting with the other Member States to gather more information on the significant use of curcuma extracts in the EU.
Ashwagandha banned in Denmark – Will other EU member states follow?
The use of the plant Withania somnifera (Ashwagandha) is another ongoing topic in the Nordic countries. Denmark has already prohibited the use of Ashwagandha in food supplements, and since a number of Swedish products with high Ashwagandha content have recently been banned in Denmark, the issue has become topical in Sweden. Now, the Finnish Food Safety Authority is also deliberating whether to follow the Danish decision based on the assessment of the Danish Technical University (DTU) from 2020. In this assessment, Ashwagandha was found to possibly have hormonal effects in both animals and humans, with adverse reproductive effects. A public consultation is currently underway requesting data on the safety of the plant.
Should the Finnish authority also decide to ban Ashwagandha from being used in food supplements, this could trigger a domino effect.
What should manufacturers do now?
Regardless of the consultations currently underway, and given the rising concerns about the safety and history of use of botanical extracts, manufacturers must have data in hand to demonstrate safe and significant use. If you have any doubts or questions about the use of botanicals, don’t hesitate to contact us for regulatory consulting.