Compliance Checklist

GPSR (General Product Safety Regulation)
Dietary Supplements
France 🇫🇷

Complete GPSR compliance checklist for dietary supplements on the French market. DGCCRF enforcement, Nutrivigilance reporting obligation, Teleservice registration and Amazon.fr mandatory fields.

Overview

The General Product Safety Regulation (GPSR, Regulation (EU) 2023/988) has applied supplementarily since December 13, 2024 to all consumer products - including dietary supplements (complements alimentaires) on Amazon.fr. In France, dietary supplements are subject to a particularly strict regulatory framework: alongside EU Directive 2002/46/EC and the GPSR, the French Decret n. 2006-352 of March 20, 2006 applies with specific national requirements. The DGCCRF monitors compliance and conducts regular targeted inspections. Particularly noteworthy is the French Nutrivigilance system at ANSES (Agence nationale de securite sanitaire), which makes reporting of adverse effects of dietary supplements mandatory. Before market placement, each supplement must be notified via the DGCCRF Teleservice.

Does this apply to my product?

This checklist applies to all economic operators placing dietary supplements on Amazon.fr. This includes: vitamin tablets, minerals, plant extracts (plantes), protein powders, omega-3 capsules, probiotics, amino acid preparations, and all products classified as dietary supplements (complement alimentaire). France has its own positive list of authorized plants (Decret du 24 juin 2014), which is stricter than in many other EU countries. Especially relevant for non-EU manufacturers shipping to France via Amazon FBA.

Step-by-Step Guide

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Regulatory Classification and Teleservice Notification

Check whether your product is classified as a dietary supplement in France and notify it before market placement via the DGCCRF Teleservice. France has specific national requirements for ingredients and maximum levels.

Estimated time: 1-3 Wochen

Check ingredients against French positive listsRequired

Check each ingredient against French positive lists: authorized vitamins and minerals (Annexes I and II of Directive 2002/46/EC), authorized plants (Arrete du 24 juin 2014 - approx. 540 plants), authorized other substances. France has lower maximum levels for many vitamins and minerals than other EU countries (Arrete du 9 mai 2006). Some ingredients authorized in Germany are prohibited or quantity-restricted in France.

Documentation of ingredient check against French positive lists

Complete Teleservice notification with the DGCCRFRequired

Per Decret n. 2006-352, Art. 15, each dietary supplement must be notified via the DGCCRF Teleservice (teleicare.dgccrf.finances.gouv.fr) before first market placement in France. The notification includes: product name, complete composition, label draft, and manufacturer details. The DGCCRF has 2 months for review - during this time the product may already be sold (so-called 'tacite acceptance').

Teleservice notification confirmation (Accusee de reception)

Designate EU Responsible Person for the French marketRequired

Per GPSR, an EU Responsible Person must be designated to serve as contact point for the DGCCRF. For dietary supplements, a responsible person familiar with French food law and the Teleservice procedure is recommended.

Power of attorney or mandate agreement with the EU Responsible Person

Prepare Risk Analysis and Technical Documentation

For dietary supplements, a GPSR-compliant risk analysis must be prepared and complete technical documentation compiled. In France, this interacts with the requirements of the Nutrivigilance system.

Estimated time: 1-3 Wochen

GPSR risk analysis considering the Nutrivigilance systemRequired

Prepare a risk analysis covering food-specific risks alongside general product safety risks: allergen risks, drug interactions, overdose risks, contamination risks. Consider ANSES Nutrivigilance reports on adverse effects of similar products.

GPSR risk analysis document (referencing Nutrivigilance data)

Compile analysis certificates and quality evidenceRequired

Compile the following documents: analysis certificates (certificats d'analyse) for each raw material and finished product, contaminant testing (heavy metals, pesticides, microbial contamination), GMP certification of the manufacturing facility, and stability data.

Analysis certificates (raw materials and finished product)GMP certificate of the production facility

Create French Labeling and Safety Notices

Labeling of dietary supplements in France must comply with the EU Food Information Regulation (FIR), Directive 2002/46/EC, and the French Decret n. 2006-352. All information must be in French.

Estimated time: 1-2 Wochen

Create complete French product labelingRequired

Labeling must include in French: product designation 'Complement alimentaire', nutrient table, ingredient list, recommended daily dose (dose journaliere recommandee), warning 'Ne pas depasser la dose journaliere recommandee', statement 'Les complements alimentaires ne se substituent pas a une alimentation variee et equilibree', best-before date, batch/lot number, manufacturer details, and EU Responsible Person contact details.

Packaging layout with complete French labeling

Verify health claimsRequired

All health claims must comply with the Health Claims Regulation (EC) No 1924/2006 and be based on the EU list of authorized claims. In France, the DGCCRF is particularly strict with health claims - unauthorized claims lead to immediate enforcement action. Also check the French register for plant claims (Arrete du 24 juin 2014).

Amazon.fr Compliance Fields and Nutrivigilance Reporting Channels

Complete the Amazon mandatory fields for Amazon.fr and establish reporting channels for the French Nutrivigilance system.

Estimated time: 2-5 Tage

Enter GPSR mandatory fields and supplement-specific data in Seller CentralRequired

Enter complete data in Amazon Seller Central: EU Responsible Person, manufacturer information, French-language safety warnings and allergen warnings. Upload the Teleservice notification confirmation as compliance evidence.

Establish Nutrivigilance reporting process with ANSESRequired

Per Art. L.1323-1 Code de la sante publique, economic operators are obligated to report adverse effects (effets indesirables) of their dietary supplements to the ANSES Nutrivigilance system. Establish an internal process to capture customer complaints about adverse effects and report them via the ANSES form (nutrivigilance-anses.fr).

Internal procedure document for Nutrivigilance reports

Establish market surveillance and complaint managementRequired

Establish a systematic register for product complaints and safety incidents. Monitor Amazon customer reviews and DGCCRF publications. Define escalation paths for reporting to ANSES (Nutrivigilance) and the DGCCRF (Safety Gate).

Common Mistakes to Avoid

DGCCRF Teleservice notification missed

Consequence: Market placement without notification is illegal. The DGCCRF can impose immediate sales bans and fines up to EUR 1,500 (natural persons) or EUR 7,500 (legal entities) per violation. Repeated violations carry higher penalties.

Prevention: Notify each dietary supplement via the Teleservice BEFORE the first sale on Amazon.fr. SpaceGoats can handle the notification for you.

French maximum levels for vitamins/minerals exceeded

Consequence: The DGCCRF can seize the product and order a recall. Criminal consequences may follow if health damage occurs. Amazon.fr removes the listing immediately.

Prevention: Check EVERY dosage against French maximum levels (Arrete du 9 mai 2006). France often has lower limits than other EU countries - a product compliant in Germany may be overdosed in France.

Unauthorized health claims used on the French listing

Consequence: Violation of the Health Claims Regulation and the Code de la consommation. The DGCCRF can initiate warnings, fines, and listing suspensions. Severe violations may lead to criminal proceedings.

Prevention: Use only authorized health claims from the EU list. Have all claims reviewed by a regulatory affairs specialist with France expertise.

Nutrivigilance reporting obligation for adverse effects not met

Consequence: Violation of Art. L.1323-1 Code de la sante publique. ANSES can involve the DGCCRF, which can impose sales bans and fines. Reputational damage from public announcement.

Prevention: Establish a systematic process for capturing and reporting adverse effects to ANSES. Train your customer service team to identify and escalate relevant complaints.

Frequently Asked Questions

Q1Do I need to register my dietary supplement in France before selling on Amazon.fr?

Yes, mandatory. Per Decret n. 2006-352, Art. 15, each dietary supplement must be notified via the DGCCRF Teleservice before market placement in France. Registration is done at teleicare.dgccrf.finances.gouv.fr and must be in French. Selling without notification is illegal.

Q2What is the Nutrivigilance system and what reporting obligations do I have?

The Nutrivigilance system is operated by ANSES and captures adverse effects of dietary supplements. Economic operators are obligated per Art. L.1323-1 Code de la sante publique to report adverse effects (effets indesirables). This includes allergic reactions, gastrointestinal problems, liver damage, and other side effects reported by customers.

Q3Can I sell a supplement authorized in Germany in France without changes?

Generally not. France has stricter maximum levels for many vitamins and minerals (e.g., Vitamin A max. 800 ug, Zinc max. 12.5 mg). Additionally, the product must be labeled in French and notified via the Teleservice. The French plant list also differs from the German one. Adjustment is almost always required.

Q4How much does GPSR compliance cost for a single dietary supplement in France?

For a single supplement, expect EUR 500-1,500: Teleservice notification (free to EUR 500), analysis certificates (EUR 200-800), packaging adaptation and translation (EUR 100-400), EU Responsible Person (EUR 200-500/year). For multiple products, unit costs decrease as processes and translation templates are reusable.

Q5Do I also need to register with Citeo (EPR) in France for my supplement packaging?

Yes. Independent of GPSR and food legislation, French EPR legislation (Loi AGEC) requires registration with Citeo for packaging. Your packaging must carry the Triman logo and info-tri sorting instructions. This is an additional obligation alongside GPSR compliance and Teleservice notification.

GPSR (General Product Safety Regulation)Dietary SupplementsFrance 🇫🇷

Regulatory Classification and Teleservice Notification

Prepare Risk Analysis and Technical Documentation

Create French Labeling and Safety Notices

Amazon.fr Compliance Fields and Nutrivigilance Reporting Channels

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