In the European Union (EU), food supplements are regulated on a community-wide level by the government bodies named The European Parliament and The Council of the European Union, with each individual Member State ensuring that food supplements comply with the EU regulations as well as implementing additional regulations where the Member deems appropriate.
Food Supplements are regulated in the EU under Directive 2002/46/EC. Under this Directive, food supplements are products marketed in various dosage forms which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, and are considered to supplement the normal diet. Nutrients include vitamins and minerals, with amino acids, essential fatty acids, fiber and various plants and herbal extracts considered “other substances”.
Within the EU Directive itself, there are restrictions on which vitamins and minerals can be used in food supplements, including their sources. There are also many ingredients which are further restricted, through other Member State regulations and additional EU regulations. In effect, it makes product launches into individual Member States daunting to the outsider. NHP Consulting offers a wide range of services to help guide companies through the various labelling, marketing and product registration processes that exist throughout the European Union. Most of the following sections focus on food supplements which is the most common request we receive, but please inquire if a product category is not covered here.