By EAS Senior Consultant Sue Oldreive
You say color, I say colour. You say “dietary supplement”, we, legally, say “food supplement.” And of course, the French say “complément alimentaire,” the Danish say “Kosttilskud” and the Italians say “Supplemento Alimentare.” With 27 different Member States within Europe, there are many more ways to say “Food Supplement.”
Although the languages may not be harmonized, the good news is that there has been much progress in the past to harmonize controls on supplements in Europe.
The publication of the Food Supplements Directive in 2002 harmonized basic controls between EU Member States, such as definitions, the forms of vitamins and minerals that can be used and warning statements for use on labels. Together with other harmonized regulations, such as those on additives, novel foods, labeling and claims, it forms a good starting point for anyone looking to market food supplements in Europe.
However, Europe is made up of countries with long traditions and strong national identities so reaching agreements on new controls can be a challenge. The Food Supplements Directive made provision to harmonize other issues relevant to dietary supplements, such as maximum and minimum levels of vitamins and minerals permitted in a daily dose and controls on other nutritional substances used in supplements, but progress on these areas has stalled. On maximum levels that has been, in large part, due to a lack of agreement on how these levels should be derived relating back to national attitude towards food supplements. Typically, countries such as the UK, The Netherlands and Sweden have had a relaxed attitude, with no upper limits set other than for a minority of substances for which there is considered to be strong evidence of a risk to health. Other countries have a history of tight limits, such as 100% Recommended Daily Allowance (RDA) per daily dose of a vitamin or mineral supplement. With such diverse starting points, it is no wonder that the debate continues. Companies looking to sell food supplements in Europe therefore need to check the limits set by each Member State in which they wish to sell.
Beyond maximum and minimum levels, some Member States have created new laws to control the use of botanical substances in food supplements, with France the latest to publish new regulations in this area. Again, until such a time that harmonization is reached, companies need to work with a local market expert to ensure the formulation of their product is compliant with the requirements of each target Member State.
When it comes to labeling your dietary supplement, the majority of the requirements are harmonized and set out clearly in both the Food Supplement Directive and the Food Information Regulations. EU Member States may have minor additional requirements which need to be checked and incorporated before notification to the local market authority and commercialisation.
Launching into Europe will take time, patience – and often a little humor to help overcome cultural differences. A complete dossier of formula, detailed raw material specifications and the proposed label declarations will go a long way towards making the process faster and smoother.