The term “Nutritional Supplements” is not a protected, clear definition in Germany. Therefore, in order to determine import/certification procedures, a U.S. exporter needs to know if his nutritional supplement would be classified as a food product or a pharmaceutical in Germany. Intermediate products which may not clearly belong to one or the other of these two groups, may be treated under the German Dietary Directive also. This directive allows illness-related indications (not allowed with nutritional supplements in Germany) and contains concise definitions to be used in the description of a product.
A U.S. nutritional supplement is not necessarily a nutritional supplement in Germany. Before exporting the product, the U.S. firm needs to determine the status of its product (pharmaceutical or food product) in Germany. Is the product status not clear upon exporting to Germany, the goods will be held in customs until the status has been clarified.
The responsible authority for product classification is the “Regierungspräsidium“ (county seat) in whose geographic authority the importing distributor is based. The county seat acts on behalf of the “Land” (state) government, since the implementation of the German Pharmaceutical Law is the responsibility of the „Laender“, the individual German states, not the Federal Legislature.
Recommended Procedure for U.S. exporters of Nutritional Supplements:
All printed product information, such as advertising, user manual, press releases, consumer advice, etc., plus two product samples should be submitted (English possible, preferably in German) to an independent private certified German laboratory. The addresses of these lab consultants (“Lebensmittelsachverständige“) are available from the local German chambers of commerce (see also, key contacts below). The consultant will assess the product and summarize findings in a report, which will confirm, as appropriate, the “food” character of the products and will forward the report and the samples to the respective county seat.