How much does the cosmetic facility declaration to the ANSM cost?

Submitting a cosmetic facility declaration on the ANSM online platform is free of charge. There are no administrative fees, duties, or government taxes owed to the French authorities for this formality. If you work with our regulatory team to compile and submit the registration on your behalf, only our professional advisory fees apply.

Does the ANSM systematically inspect the facility before granting authorization?

No. The issuance of the declaration receipt is an administrative registration process, not a prior operating license. The ANSM does not mandate an on-site pre-operational inspection before authorizing you to manufacture. However, your registered site is placed on the official national registry of inspectable establishments, and ANSM or DGCCRF inspectors may conduct unannounced or planned on-site inspections at any point during your operations.

What happens if I manufacture inside a shared rental space (incubator, coworking workshop)?

If you rent a space within a business incubator, artisan workshop collective, or shared laboratory to produce your cosmetics, you must declare the exact physical address and suite of that workshop as your manufacturing site. If the incubator hosts several independent cosmetic businesses, each tenant company must file its own distinct facility declaration for its designated unit, certifying that the dedicated workspace satisfies ISO 22716 GMP standards.

French ANSM Cosmetic Facility Declaration: Guide

Cosmetic facility declaration to the ANSM: obligations, timelines, and procedures

If you manufacture or package cosmetic products in France, you are legally required to register your manufacturing facility with the ANSM (French National Agency for the Safety of Medicines and Health Products - Agence Nationale de Sécurité du Médicament et des Produits de Santé). Often overlooked by artisanal manufacturers or beginning soap makers, this statutory requirement is nonetheless an essential milestone in the French regulatory compliance journey. Here is everything you need to know to successfully submit your cosmetic facility declaration.

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Why is the cosmetic facility declaration to the ANSM mandatory?

Article L. 5131-2 of the French Public Health Code (Code de la Santé Publique) mandates that any natural or legal person carrying out the manufacture or packaging of cosmetic products must declare their facility to the ANSM.

The purpose of this mandatory registration is to enable French health authorities to:

Maintain an accurate mapping of all cosmetic manufacturing and packaging sites operating on French national territory.
Plan and conduct regulatory inspections for compliance with Good Manufacturing Practices (GMP / ISO 22716).
Respond swiftly in the event of cosmetovigilance alerts or serious undesirable effects (SUE) by targeting the responsible production facility without delay.

This declaration must be filed prior to commencing actual manufacturing or packaging activities. It must not be confused with compiling the cosmetic PIF (which pertains directly to the cosmetic product itself) or notifying products on the European CPNP portal (which identifies the finished formula before sale). The facility declaration specifically registers the physical site and the legal entity engaged in production.

🔬 Insights from our Cosmetic Regulatory Specialist

"The facility declaration is a specific French national requirement linked to the market surveillance authority of the ANSM. It applies to any manufacturing or packaging workshop physically situated on French territory. If you outsource 100% of your production to a third-party contract manufacturer (CDMO), that contract manufacturer must hold the facility declaration as the producer. Conversely, if you import finished products from outside the EU and repackage or label them under your brand name in France (secondary packaging), you are legally classified as a packager and must file this facility declaration. This is a crucial distinction on which we regularly advise brand creators during our regulatory onboarding."

Who must submit this cosmetic facility declaration?

The obligation to register a facility with the ANSM applies to:

Artisanal manufacturers and cold-process soap makers producing small batches.
Industrial contract manufacturers, formulators, and cosmetic subcontractor laboratories.
Companies performing primary packaging (filling bulk formulations into bottles, jars, or tubes).
Companies performing secondary packaging (applying labels, placing products into unit folding boxes) if this alters the original protective packaging.
R&D laboratories preparing clinical trial batches or promotional sample units.

Standard distributors who purchase pre-packaged, pre-labeled finished products within the EU for resale without modification are exempt from this facility declaration requirement. To learn more about validation requirements by business type, explore our dedicated PIF service packages and our tailored PIF regulatory support programs.

⚠️ 3 frequent compliance mistakes in ANSM facility declarations

Declaring the facility after production has already started: the declaration must be submitted before initiating manufacture or packaging of your very first commercial batch. Selling cosmetic products produced in an undeclared workshop is subject to administrative fines of up to 15,000 euros under French law.
Failing to report major modifications: any significant operational change (address relocation, addition of flammable or aerosol production lines, cessation of activities) must be reported via an amended declaration to the ANSM within one month.
Failing to designate a qualified GMP manager: the declaration form mandates identifying the qualified person responsible for overseeing GMP compliance within the facility. This individual must possess the technical qualifications and competencies required under ISO 22716.

Cosmetic GMP ISO 22716 compliance

Practical protocol for declaring your facility

In France, the cosmetic facility declaration is completed online through the ANSM secure tele-procedure portal (the Démarches Simplifiées governmental platform). The registration dossier must include:

Corporate legal identifiers (Kbis extract, SIRET number, NAF/APE business activity code).
The exact physical address of the manufacturing or packaging site.
A detailed description of on-site manufacturing activities (anhydrous products, emulsions, alcohol-based perfumes, filling and packing operations).
The identity, qualifications, and curriculum vitae of the person designated responsible for Good Manufacturing Practices (GMP).
A formal sworn statement certifying that the facility operates in strict adherence to the principles of cosmetic GMP outlined in standard ISO 22716.

Upon submission and verification, the ANSM issues an official facility declaration receipt with a unique registration tracking number. This document must be retained and presented during regulatory audits or DGCCRF inspections. To maintain ongoing compliance for your premises, consult our practical guide to cosmetic GMP ISO 22716 and stay informed on regulatory developments in our cosmetic PIF regulatory updates.

Frequently asked questions about ANSM Facility Declarations

How much does the cosmetic facility declaration to the ANSM cost?: Submitting a cosmetic facility declaration on the ANSM online platform is free of charge. There are no administrative fees, duties, or government taxes owed to the French authorities for this formality. If you work with our regulatory team to compile and submit the registration on your behalf, only our professional advisory fees apply.
Does the ANSM systematically inspect the facility before granting authorization?: No. The issuance of the declaration receipt is an administrative registration process, not a prior operating license. The ANSM does not mandate an on-site pre-operational inspection before authorizing you to manufacture. However, your registered site is placed on the official national registry of inspectable establishments, and ANSM or DGCCRF inspectors may conduct unannounced or planned on-site inspections at any point during your operations.
What happens if I manufacture inside a shared rental space (incubator, coworking workshop)?: If you rent a space within a business incubator, artisan workshop collective, or shared laboratory to produce your cosmetics, you must declare the exact physical address and suite of that workshop as your manufacturing site. If the incubator hosts several independent cosmetic businesses, each tenant company must file its own distinct facility declaration for its designated unit, certifying that the dedicated workspace satisfies ISO 22716 GMP standards.