Munich-based attorney Andreas Wolf concludes his overview of supplement manufacturers looking to enter the EU. Click here for part one.
VI. Maximum and minimum levels of vitamins and minerals in Food Supplements
The intake levels of vitamins and minerals have been causes of concern both for being potentially on the low side but also because of the adverse effects that excessive intakes of certain vitamins and minerals may cause.
For the EU Commission, it is increasingly difficult to develop accurate assessments of the pattern of overall diets since these vary across the regions of the EU, between population groups, and over time. Changing culinary and social habits have led to low intakes for some vitamins and minerals compared to those being recommended for certain groups of the population, although the vitamins and minerals and the groups of the population concerned may vary from Member State to Member State. In addition, there are good arguments that optimal health may depend on higher levels of vitamins and minerals than those recommended today on the basis of avoiding deficiencies.
As a result, products that contribute to the intake of vitamins and minerals beyond the levels that would be provided by the natural content of foods have increased considerably on the market. The setting of maximum levels for vitamins and minerals is increasingly becoming a pressing need for the responsible authorities to ensure that the potential sum of intakes from all sources on the market should not threaten to undermine the high level of human health which the EU Treaty sets as the policy objective.
In addition, the application of divergent maximum permitted levels of vitamins and minerals in Members States is causing serious problems to the free circulation of the products concerned in the European market. The same applies for NON - EU products, of course.
The maximum levels for vitamins and minerals have not been set in Directive 2002/46/EC on food supplements, but have to be established by the Commission through the Regulatory Committee as an implementing measure in the future.
Vitamins and minerals used in food supplements or added to foods should also result in a minimum amount being present. Otherwise, the presence of minor amounts would not offer any benefit to consumers, namely to supplement the normal diet in the case of food supplements. Plus, it would therefore be misleading.
Until this regulation on an EU level will be finalized, the specific national levels still have to be considered.
The products covered by the Directive 2002/46/EC are sold and marketed under the name “food supplements.”
By law, the presentation and advertising of food supplements must contain:
a) The names of the categories of the nutrients or substances that characterize the product.
b) The portion of the product recommended for daily consumption and a warning of the risks to health if this is exceeded.
c) A declaration to the effect that the supplement is not a substitute for a varied diet.
d) The reference "This is not a medicinal product", where the presentation of the product is similar to that of a medicinal product;
e) A warning to the effect that the product should be stored out of the reach of young children.
The labelling of food supplements must not contain:
a) Any statement attributing to the product properties of preventing, treating, or curing a human disease.
b) Any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.
VIII. Monitoring of Food Supplements
To facilitate efficient monitoring of food supplements, the Directive provides that Member States may require the manufacturer or the person placing the product on the market in their territory (Importer of Record) to notify the appropriate authority of that placing on the market by forwarding a model of the label used for the specific product prior to sale.
That’s enough for now. I’ll return with my second part sometime soon.
Andreas Wolf can be reached at email@example.com.