Compliance Checklist

GPSR (General Product Safety Regulation)
Dietary Supplements
Germany 🇩🇪

Complete compliance checklist for the General Product Safety Regulation (EU) 2023/988 for dietary supplements on the German market. Covers NemV, LFGB, BVL notification obligation, Novel Food Regulation, and Health Claims Regulation.

Overview

Dietary supplements in Germany are subject to a complex regulatory framework of EU regulations and national law. The GPSR (EU) 2023/988 has introduced additional product safety requirements since December 2024, while the Nahrungsergaenzungsmittelverordnung (NemV) governs product-specific provisions. Before placing on the market, notification to the Federal Office for Consumer Protection and Food Safety (BVL) is mandatory. This checklist guides you through all necessary steps to sell dietary supplements in compliance with GPSR and food law in Germany.

Does this apply to my product?

This checklist applies to all economic operators placing dietary supplements (vitamins, minerals, amino acids, plant extracts, probiotics, omega-3 fatty acids, sports nutrition, etc.) on the German market. Covers manufacturers, importers, distributors, and online sellers. Especially relevant for non-EU manufacturers and private-label providers selling supplements via Amazon.de, eBay, or own shops.

Step-by-Step Guide

Progress0/16 (0%)

Verify Legal Classification and Authorization Status

Before anything else, you must ensure your product is actually classified as a dietary supplement and not as a medicinal product, novel food, or dietetic food. The classification has massive regulatory consequences.

Estimated time: 3-14 Tage

Check demarcation from medicinal productsRequired

Check whether your product could be classified as a medicinal product due to dosage, dosage form, or claims. In Germany, the BfArM (Federal Institute for Drugs) decides in doubtful cases. High-dose products (e.g., Vitamin D above 800 IU, melatonin above 0.5 mg) or pharmaceutical dosage forms can cross the boundary.

Check Novel Food status of all ingredientsRequired

Check every ingredient in the EU Novel Food Catalogue (Regulation (EU) 2015/2283). Ingredients not consumed to a significant degree in the EU before May 15, 1997 qualify as Novel Food and require authorization through EFSA. Examples: CBD, certain algae extracts, exotic plant extracts.

Novel Food status check for all ingredients

Verify permitted vitamins and minerals per NemV Annex 1 and 2Required

NemV Annex 1 lists the permitted vitamins and minerals, Annex 2 the permitted compounds. Only substances and compounds listed there may be used in supplements. Also check BfR maximum level recommendations, as Germany applies stricter upper limits than many other EU countries.

Complete BVL Notification and Food Law Fundamentals

Per Section 5 NemV, every dietary supplement must be notified to the BVL before it is first placed on the German market. Additionally, the general food law requirements of the LFGB must be met.

Estimated time: 1-4 Wochen

Submit BVL notification via the online portalRequired

Submit the notification via the BVL portal (bvl.bund.de). Required: product name, composition with quantities per daily dose, dosage form, vitamin and mineral compounds used, designation of the food, label specimen. The notification is free of charge but mandatory.

BVL notification confirmationSpecimen of the product label

Food business operator registration with competent authorityRequired

Per Art. 6 of Regulation (EC) No. 852/2004, every food business operator must register with the competent food safety authority. In Germany, these are the veterinary and food safety offices of the districts or independent cities.

Registration confirmation from the competent food safety authority

Ensure HACCP conceptRequired

As a food business operator, you must have implemented a HACCP concept (Hazard Analysis and Critical Control Points). This also applies to pure traders who import and store supplements. Document the critical control points, especially storage temperature, humidity control, and prevention of cross-contamination.

Implement GPSR Requirements for Dietary Supplements

The GPSR also applies to food in areas not covered by specific EU food law, particularly regarding general product safety, traceability, and EU responsible person obligations for non-EU manufacturers.

Estimated time: 1-2 Wochen

Designate EU responsible person (for non-EU manufacturers)Required

Non-EU manufacturers must designate an EU responsible person per GPSR Art. 16. For supplements, this responsible person should ideally also have experience with food law, as they must be able to present food law documentation upon authority requests.

Set up product traceability per GPSR and food lawRequired

Implement a traceability system that meets both GPSR requirements (unique product identification) and food law requirements of Regulation (EC) No. 178/2002 Art. 18 (supplier and customer traceability, batch tracking).

Set up rapid alert system and reporting obligationsRequired

Set up processes to fulfill both RASFF (Rapid Alert System for Food and Feed) and GPSR reporting obligations to BAuA in case of safety issues. Inform the competent food safety authority immediately if products suspected of being harmful to health.

Correctly Implement Labeling and Health Claims

Labeling of supplements in Germany must simultaneously comply with the FIC (Regulation (EU) No. 1169/2011), NemV, Health Claims Regulation (EC) No. 1924/2006, and GPSR requirements. Incorrect labeling is the most common reason for cease-and-desist letters and objections.

Estimated time: 1-3 Wochen

Create mandatory labeling per FIC and NemVRequired

The label must contain: designation 'Nahrungsergaenzungsmittel' (food supplement), nutrition table with nutrient amounts per daily dose and %NRV, complete ingredient list in descending order, recommended daily intake, warning 'Do not exceed the recommended daily intake', note 'Not a substitute for a balanced diet', storage instructions, best before date, net quantity, batch number.

Label design with all mandatory markings

Verify health claims and use only authorized claimsRequired

Check every health claim in the EU register of authorized health claims (Regulation (EU) No. 432/2012). Only claims on the EU positive list may be used. Disease-related claims (Art. 13.5, Art. 14) are prohibited for supplements. Also check the BVL database for general rulings on health claims.

Allergen labeling and warnings for special groupsRequired

Label all 14 declarable allergens per FIC Annex II (e.g., soy, milk, fish for omega-3, shellfish for glucosamine). Add warnings for pregnant women, nursing mothers, children, and persons under medical treatment where relevant.

Prepare Packaging Registration and Online Distribution

For distribution in Germany, you must complete packaging registration with LUCID and design your online listings GPSR-compliant. For supplements, special care is needed regarding presentation on online marketplaces.

Estimated time: 3-7 Tage

Complete LUCID packaging registrationRequired

Register all packaging in the LUCID register of the Zentrale Stelle Verpackungsregister (verpackungsregister.org) and conclude a contract with a dual system. Note that blister packaging and outer cartons must be licensed separately.

LUCID registration confirmation

Design online listings GPSR and FIC compliantRequired

Ensure all online listings (Amazon, eBay, own shop) contain the FIC mandatory information for distance selling: ingredient list, allergens, nutrition table, net quantity, best before date, storage instructions, EU responsible person contact details. Avoid prohibited health claims in bullet points or product titles.

Ensure Quality Control and Ongoing Compliance

Supplements require ongoing quality controls and monitoring of regulatory developments. Authorities in Germany (BVL, state food safety offices) conduct regular inspections.

Estimated time: laufend

Regular laboratory analyses of product batchesRequired

Regularly test retention samples and new batches for microbiological purity, heavy metal contamination, pesticide residues, and active ingredient content. For supplements, the contaminant maximum levels of Regulation (EC) No. 1881/2006 apply.

Certificates of Analysis (CoA) per batch

Monitor regulatory changes (health claims, Novel Food)Required

Continuously monitor changes to the health claims positive list, updates to the Novel Food Catalogue, new BfR assessments on maximum levels, and NemV amendments. Adapt formulations and labeling promptly.

Common Mistakes to Avoid

Unauthorized health claims on label or in online listings

Consequence: Cease-and-desist from competitors or associations (e.g., Wettbewerbszentrale) costing EUR 1,000-5,000 per letter. Repeat offenses lead to injunction claims with dispute values of EUR 25,000-100,000. Fines from food safety authorities.

Prevention: Use exclusively claims from the EU positive list (Regulation (EU) No. 432/2012) in the exact wording. Have all texts reviewed by a food law attorney.

BVL notification before placing on market forgotten

Consequence: Administrative offense under NemV with fine. During official inspection, an immediate sales ban can be imposed until the notification is completed.

Prevention: Submit the BVL notification for every new product immediately after finalizing the formulation and label. The notification is free of charge and can be done online.

Novel Food ingredients used without authorization

Consequence: Violation of Regulation (EU) 2015/2283 - the product is not marketable. Immediate sales ban, recall obligation, and substantial fines. The entire product must be removed from the market.

Prevention: Check every ingredient in the EU Novel Food Catalogue (ec.europa.eu/food/safety/novel-food). If in doubt, commission regulatory consulting or submit an inquiry to the competent state authority.

Overdosing vitamins and minerals above BfR recommendations

Consequence: Possible classification as medicinal product by authorities (medicinal presentation). Cease-and-desist risk and sales ban. In severe cases, criminal prosecution for placing unauthorized medicines on the market.

Prevention: Follow the BfR maximum level recommendations (2021) and EFSA Tolerable Upper Intake Levels. For the German market, BfR values effectively serve as guidelines.

Missing or incomplete allergen labeling

Consequence: Health risk for allergy sufferers, RASFF notification, product recall, liability for health damages. Violation of FIC Art. 9 and 21 with fines.

Prevention: Conduct a complete allergen analysis for all raw materials and production lines. Label all 14 allergens of FIC Annex II highlighted in the ingredient list.

Frequently Asked Questions

Q1Do I have to wait for BVL notification approval before I can sell my supplement?

The BVL notification is a pure notification obligation, not an approval. You must submit the notification before first placing on the market but may sell immediately thereafter. The BVL does not verify marketability - this responsibility lies with the food business operator. However, competent state authorities can verify marketability at any time.

Q2May I advertise with claims like 'strengthens the immune system'?

No. The authorized health claim reads: 'Vitamin C contributes to the normal function of the immune system'. You must use the exact wording from the EU positive list and comply with the conditions of use (e.g., minimum vitamin content per daily dose). Exaggerations, absolute claims, and disease-related claims are prohibited.

Q3Does the GPSR also apply to dietary supplements?

Yes, the GPSR applies to all consumer products, including food and supplements, insofar as not regulated by specific EU food law. In particular, the obligation to designate an EU responsible person, the requirements for online marketplaces, and the enhanced reporting obligations for safety issues also apply to supplements.

Q4What is the legal status of BfR maximum level recommendations?

The BfR recommendations are not legally binding, as there are no EU-harmonized maximum levels for vitamins and minerals in supplements to date. In practice, however, German surveillance authorities and courts strongly orient themselves by BfR values. Exceeding them requires sound scientific justification and carries considerable regulatory risks.

Q5What special rules apply to probiotics as supplements?

Probiotics as supplements fall under the same regulations. Special note: the term 'probiotic' itself is considered an implicit health claim by the EU Commission and may not be used in advertising without an authorized claim. EFSA has not yet approved any probiotic health claim. Also check the Novel Food status of newer bacterial strains.

GPSR (General Product Safety Regulation)Dietary SupplementsGermany 🇩🇪