Food Supplements Registration in Germany - Overview
Germany is the second-largest market for food supplements in the EU, attracting companies in the sector. National regulations governed by the German Food Supplement Ordinance of May 24, 2004, implementing Directive 2002/46/EC, oversee the classification of food supplements. The classification of a product as a food supplement in other markets does not automatically classify it as such in the EU or Germany. Compliance with permitted substances, maximum levels, and banned substances is crucial. Ensuring accurate food labeling, advertising, and health claims verification is necessary to maintain food safety in Germany, and to avoid sanctions, product withdrawal, or recalls.
The competent authority for food safety in Germany is the Federal Office of Consumer Protection and Food Safety (BVL). The BVL has published guidelines over the years, providing valuable information for Food Business Operators (FBOs) on selling and advertising food supplements in Germany. Germany has also regulated botanicals, with Federal and state lists of substances. Maximum levels of vitamins and minerals are not established at the national level, but guideline levels have been provided. Unlike some other countries, Germany does not have a positive list of other substances with nutritional and physiological effects, and it is the responsibility of the operator to evaluate the permissibility of a food ingredient.
Germany is an attractive market for companies in sports nutrition, probiotics, botanicals, and mushroom food supplements. Importing and selling food supplements in Germany, including online platforms like Amazon or other e-commerce marketplaces, requires undergoing a notification procedure. Once the notification is complete, the product is registered with the Federal Office of Consumer Protection and Food Safety (BVL). Notification presupposes verification of formula compliance and product labeling. For a nutrient to be used in a food, it must have a significant History of Safe Use (HoSU) within the EU as evidence of safety. Failure to meet this criterion classifies the substance as a "novel food", requiring prior authorization. Novel food registration occurs at the EU level.
Selling food supplements in Germany after Brexit or from non-EU countries [including the United Kingdom (UK)] requires establishing a legal entity in an EU member state or appointing a third party as the product's Legal Representative (LR) in Germany or other EU countries. The representative company must be mentioned on the label, act as the point of contact for the authority, and establish applicable procedures.
Food products other than food supplements generally do not require notification in Germany. However, Foods for Specific Groups (FSG), such as infant formulas, follow-on formulas, total diet replacement products for weight control, or Foods for Special Medical Purposes (FSMP), fall under regulated products and require notification. Fortified foods do not necessitate notification. Food Business Operators (FBOs) must ensure compliance with all food regulations regarding composition and labeling.
The food market in Germany and the EU is dynamic, requiring companies to stay abreast of rapid Regulatory updates. Freyr, with an operational and delivery center in the EU, provides comprehensive Regulatory support to manufacturers, distributors, and FBOs. Our food Regulatory services in Germany encompass Regulatory assessments of formulas or ingredients, health claims, food labeling, advertising, product notification, Legal Representation (LR), as well as surveillance and vigilance, and food supplement registration in Germany.
Food Supplements Registration in Germany
Expertise
- Food Product Classification/Food Supplement Classification.
- Formula Review/Ingredients Assessment.
- Safety Assessment of Finished Products/Food Ingredients.
- Label and Claims Review.
- Nutritional and Health Claims Consultation and Substantiation.
- NHCR Claims Application (EU Register on Nutrition and Health Claims).
- Environmental Labeling/Recycling Labeling Review and Review of Green Claims.
- Packaging Material Requirements.
- Dossier Gap Analysis.
- Dossier Compilation and Submission.
- Food Product Compliance.
- Product Notification/Food Supplements Registration in Germany.
- EU Country-specific Regulatory Support.
- Regulatory Strategy for the EU.
- EU Legal Representation.
- Regulatory Intelligence (RI) Report.
- Product-specific updates on the Regulatory Guidelines/Standards.
- Novel Food Authorization Request/Traditional Food from a Third Country Registration/ Novel Food Registration.
- Consultation Processes for Determining the Status (novel/not novel) of a Food Ingredient.
- Regulatory Guidance on Food Products/Food Supplements Import Services in the EU.
- Translation Support Services.
- Review of Advertising Promotional Material.
- Food Surveillance and Vigilance.
- Post-notification/Post-marketing Follow-up.
- Management of Alerts and Authorities’ Remarks.
- FBO Registration Support.
- Communication with Health Authorities (HAs).
- Product Compliance for European Economic Area Countries Outside the EU (Switzerland, Norway, and Iceland).
- End-to-end Services for Fortified Foods, Food for Special Medical Purposes (FSMP), Infant Formula, Follow-on Formula, and other Foods for Specific Groups (FSG).
Advantages
- End-to-end Regulatory consultation.
- Market-specific Regulatory consulting and advice.
- Harmonized compliance, local labeling, and local market support.
- Qualified team of experts with hands-on experience across all categories of foods.
- Support for region-specific Regulatory activities.
- Extensive partner network across the globe.
- A strong relationship with various HAs.
