Dietary Supplements on Amazon amazon.de
Germany 🇩🇪

No, dietary supplements do not require authorization in Germany. They are subject to a notification requirement: before first placing on the market, a notification must be submitted to the BVL (Federal Office of Consumer Protection and Food Safety) per Section 5 NemV. This is a pure notification, not an approval - the BVL does not review the efficacy or safety of the product. Responsibility for safety and marketability lies entirely with the person placing it on the market (retailer or manufacturer). Additionally, the product must meet all requirements of the NemV, LMIV, and Health Claims Regulation. For selling on Amazon, compliance with Amazon-specific policies for dietary supplements is also required.

You may only use health claims authorized in the EU positive list (Community Register per Articles 13 and 14 of Regulation (EC) No 1924/2006). This list is maintained by EFSA and is publicly accessible. Examples of authorized claims: 'Vitamin C contributes to the normal function of the immune system' or 'Calcium is needed for the maintenance of normal bones.' Not permitted are: disease-related claims ('protects against colds'), exaggerated efficacy promises ('miracle cure'), references to medical recommendations, or healing promises. Amazon also checks listings for unauthorized health claims and can suspend listings. Additionally, competitors or consumer protection associations can issue cease-and-desist letters, which can cost 1,500-5,000 EUR per violation.

Dietary supplements are classified as food products under tax law and therefore fall under the reduced VAT rate of 7% per Section 12(2) No. 1 UStG in conjunction with Annex 2 to the UStG. This applies provided the product is declared as a dietary supplement within the meaning of the NemV and offered in standard dosage forms (capsules, tablets, powder, drops, small juices). Important exceptions: Products not classified as food (e.g., certain dietetic foods, medical devices) are subject to the standard rate of 19%. Cosmetic products (e.g., collagen drinks marketed as cosmetics) also fall under 19%. It is therefore crucial to correctly classify your products and use the correct commodity code (CN code).

If an ingredient is classified as a novel food under Regulation (EU) 2015/2283 and no authorization exists, the product may not be sold in the EU. Selling a non-authorized Novel Food product is an administrative offense and can be penalized with fines of up to 50,000 EUR. Amazon will suspend the listing if authorities or competitors report the violation. Therefore, check the EU Novel Food Catalogue for every ingredient before product development. Commonly affected ingredients in the supplement space: CBD (not authorized), certain mushroom extracts, exotic plant extracts, synthetic active ingredients, and novel protein sources. For unclear status, a regulatory opinion is recommended (200-1,500 EUR). A Novel Food authorization procedure costs 50,000-500,000 EUR and takes 18-24 months - not an option for most sellers.

Amazon requires the following for selling supplements on amazon.de: (1) The product must be correctly categorized as a dietary supplement. (2) The product detail page must contain all mandatory information per LMIV (ingredient list, nutrient table, intake recommendation, warnings). (3) Amazon may request proof of marketability at any time: BVL notification confirmation, laboratory analyses, declaration of conformity. (4) Health claims must be EU-compliant - Amazon reviews and suspends listings with unauthorized claims. (5) The best-before date must be indicated on packaging, and products with less than 90 days remaining shelf life will not be shipped by FBA. (6) LUCID registration number must be stored in Seller Central (VerpackG obligation). (7) For some supplement subcategories, Amazon may require category approval (gating/ungating).