Introduction of dietary supplements on the German market involves compliance with a number of regulations at both national and EU level. Dietary supplements are regulated as food. This means that they have to meet certain standards regarding safety, composition and labelling. In this article, we present the most important information on the notification procedures for dietary supplements. We also discuss labelling requirements and legal liability in the German market.
Legal basis for food supplements
Dietary supplements in Germany are regulated by:
- German Food and Feedstuffs Act (LFGB), which lays down rules for all food products, including food supplements.
- Regulation (EC) No 178/2002, which lays down the general principles of food law in the European Union.
- Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 concerning food supplements.
- German Ordinance on Dietary Supplements (NemV - Nahrungsergänzungsmittelverordnung), which details the requirements for the composition, labelling and notification procedures for dietary supplements in Germany.
Registration of food supplements in Germany
Before a food supplement can be marketed in Germany, the product must be notified to the Federal Office for Consumer Protection and Food Safety (BVL). This process is mandatory and follows from § 5 of the German Dietary Supplements Ordinance (NemV).
Who must make the notification?
The notification must be made by the economic operator responsible for placing the product on the German market. This can be the manufacturer, importer or distributor. This operator becomes responsible for the compliance of the product with the law.
Required documents for application
- Application form - includes details of the product name, composition, recommended daily dose, manufacturer, importer, as well as packaging and labelling information.
- Product label - should comply with German regulations and contain all the required information in German. These include: trade name, ingredients, nutritional values, daily dose, recommendations for use, warnings and contraindications.
- Promotional material - if there are any promotional materials (leaflets, brochures) used on the German market, these must be enclosed with the application.
- Safety information - any available information on the safety of the food supplement, such as laboratory results, toxicological data or reports of side effects.
Labelling of food supplements
The labelling of dietary supplements on the German market must comply with the requirements of the Regulation (EU) No 1169/2011. This also applies to Regulations on food supplements (NemV). All information should be in German.
What should the label contain?
- The name of the product and the term 'food supplement'.
- List of ingredients, including active substances and their content.
- Recommended daily intake.
- Application warnings.
- Nutrition and health claims (if applicable).
- Details of the manufacturer or distributor.
- Production batch number and expiry date.
- Storage instructions.
Penalties for non-compliance
In the event of failure to declare a dietary supplement to the BVL or incorrect labelling, severe penalties may be imposed. According to § 60 LFGB, fines can be as high as EUR 50,000. In addition, the supervisory authorities can order a product recall. This entails additional costs and reputational damage for the company.
Or are you interested in packaging policy in Germany? Find out if you need to register for LUCID. For more information, see the article: Marketing products abroad Germany - analysis of packaging and labelling regulations.
Summary
If you are a manufacturer, distributor or importer of dietary supplements, make sure that the information on the labels complies with the requirements of the local markets. This also applies to promotional materials. Notification of dietary supplements to the relevant authorities and compliance with local and EU regulations are key. These are essential steps when marketing these products abroad.
Would you like to consult your case with our specialist? Call or write to us. We would be happy to meet and discuss minimising the risks associated with the distribution of your dietary supplements.
Contact us - www.bktkancelaria.pl/kontakt.
