EU Regulations Concerning Food Supplements and Botanical Nutraceuticals

The EU Regulations for Botanical Nutraceuticals and Food Supplements

Botanicals are considered a food or food supplement in the European Union (EU) and fall under the EU’s Novel Food Regulation. They fall under the directive of 2006/42/EC. 

• This regulation defines novel foods as any food not used for human consumption within the EU before May 1997. 
• Nutraceuticals, on the other hand, are not explicitly defined under EU law. Depending on their composition and intended use, they can be categorized as food supplements or fortified food. 
• The regulatory status of botanicals as food supplements in the EU is subject to specific requirements, including product labeling, safety, and claims substantiation. However,  legislations on botanicals are lesser than on vitamins and minerals. 
• Botanicals must comply with the EU’s Regulation on Food Information to Consumers (FIC) and the EU’s Nutrition and Health Claims Regulation (NHCR). 

• Furthermore, botanicals used in traditional medicine may be subject to additional regulatory requirements under the EU’s Traditional Herbal Medicinal Products Directive (THMPD) since botanicals are considered food in some member states, while medicine in others.  
• It is necessitated that the products should not be labelled, presented or advertised as capable of preventing or curing a disease. 
• It should also be noted that the health claims should not be misleading, insinuating that a balanced diet cannot replace the nutritional value of a botanical nutraceutical. 

In addition, the THMPD requires a product to be registered as a traditional herbal medicinal product and comply with specific quality, safety, and efficacy requirements [1].