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Pharma & Dietary Supplements

Import & Export

Fast and smooth import and export of dietary supplements

The import and export of dietary supplements are essential transaction opportunities to increase your sales. For a smooth transaction, certain legal regulations must be implemented.

Import of dietary supplements

When importing or distributing foreign dietary supplements in the domestic market, all food law regulations must be observed.

For example, all additives in the foreign dietary supplements must have German approval, otherwise the dietary supplements might not be distributed in Germany. However, for food supplements with additives without German approval, there is a simplified possibility to obtain a general ruling for the additives used. However, this only applies if the food was lawfully manufactured in a member state of the European Union or the European Economic Area or is lawfully marketed there. Food supplements from outside the EU may also contain ingredients that are novel food ingredients under European law. In this case, an application for testing and approval must be submitted before the product is placed on the market for the first time.

Likewise, food supplements must be notified to the Federal Office of Consumer Protection and Food Safety (BVL) in accordance with Section 5 of the Food Supplements Regulation (NemV) no later than the first time they are placed on the market. For the distribution of food supplements in Germany, a business registration with the responsible local authority is mandatory.

In the case of a foreign food supplement that is to be imported, a legal product classification must take place. Many of the “dietary supplements” sold abroad are not dietary supplements under German or EU law, but instead are medicinal products, i.e., products with a pharmacological effect that must be registered with the medicinal products authority.

Foreign dietary supplements imported into Germany must not contain any prohibited or unauthorized ingredients or constituents. The maximum quantity regulations (e.g., additives and contaminants) must be observed. Food supplements must not contain any unauthorized impurities or contaminants. It must be possible to check the composition by examining random samples. Compliance with the general labeling regulations for foodstuffs (e.g., Food Labeling Ordinance, Lot Labeling Ordinance, and Food Information Ordinance) and the special regulations for food supplements (NemV) also required. For example, labeling must generally be in German on the packages and the labeling of some ingredients on the package is mandatory.

When importing food supplements, it is also necessary to find out which customs offices are authorized for the import and which clearance authorities are authorized.

Export of food supplements

In the EU, the principle of free movement of goods applies. This means that all food supplements that are legally on the market in a member state of the EU may be imported and marketed in other member states, even if they do not comply with the national regulations in force there. When food supplements are exported to a third country, the relevant requirements of food law (Article 12 of Regulation (EC) No 178/2002) must be met. An exception is when the authorities of the importing country have established other regulations. Some third countries only approve imports from companies that are already known there through prior registration or approval and have been included in corresponding lists of registered or approved companies. When a third country informs the Federal Ministry of Food and Agriculture (BMEL) that companies willing to export or already exporting must be listed/registered for export to the third country, all available information is processed at the BVL and made available to the countries and affected trade associations.

The import and export regulations are complex and vary greatly depending on the country. We are happy to help you. Just contact us!