The European market for dietary supplements, including liquid supplements and vitamins, is booming, driven by increasing consumer health consciousness. However, entering and successfully navigating this market requires a thorough understanding of its regulatory framework, which can be complex and varies significantly from other regions like the United States. This blog post will explore key aspects of European regulations about selling liquid supplements and vitamins, offering guidance for companies looking to expand their presence in Europe.
The European Union (EU) considers dietary supplements as food items, and they are regulated primarily under Directive 2002/46/EC, which concerns nutritional supplements, and Regulation (EC) No 1924/2006, which relates to nutrition and health claims made on foods.
EFSA plays a crucial role in regulating liquid supplements and vitamins. It assesses the safety of ingredients and evaluates health claims made by manufacturers. For a health claim to be approved, EFSA must confirm that it is backed by scientific evidence. Manufacturers looking to market a new supplement or make specific health claims must have their products and claims reviewed and approved by EFSA.
Labelling is a critical aspect of the regulations governing dietary supplements in the EU. Labels must provide the following information:
The labels must also be translated into the language(s) of the country where the product is being sold.
Before placing a dietary supplement on the European market, companies must notify the national competent authority of the member state where the product will be sold. This notification must include a label sample and details about the product formulation. Different EU countries may have additional specific requirements, so it is vital to check local regulations.
The EU mandates that dietary supplements be produced according to high-quality standards to ensure consumer safety. Manufacturers must comply with Good Manufacturing Practices (GMP) to ensure products are consistently produced and controlled according to quality standards.
While the EU provides a harmonised regulatory framework, each member state implements these rules differently. Companies must be aware of these variations and may need to make adjustments when selling in multiple countries within the EU.