Cosmetic Fragrance Regulations in France: EU 1223/2009 in Practice

Fragrance sits at the intersection of two regulatory worlds. A reed diffuser is a consumer product governed by CLP and GPSR. A perfumed body lotion, body mist, or scented roll-on is a cosmetic product governed by Regulation (EC) No 1223/2009, which is significantly more demanding. For B2B buyers importing fragrance-containing cosmetics into France, understanding where the line falls, and what 1223/2009 requires in practice, is essential.

What Counts as a Cosmetic Product

Article 2 of Regulation 1223/2009 defines a cosmetic as any substance or mixture intended to be placed in contact with the external parts of the human body, including the skin, hair, nails, lips, and external genital organs, or with the teeth and mucous membranes of the mouth, with a view to cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odours.

Fragrance products that fall under 1223/2009 include:

• Eau de parfum, eau de toilette, eau de cologne.
• Body mists and body splashes.
• Perfumed body lotions, oils, and creams.
• Scented roll-ons and solid perfumes.
• Fragranced soaps, shower gels, and bath products.
• Scented hair mists.

Products that do not fall under 1223/2009 include reed diffusers, candles, room sprays, and wardrobe sachets, which are governed by CLP, GPSR, and aerosol rules where applicable.

The Seven Core Obligations

1. Responsible Person

Every cosmetic placed on the EU market must have a designated Responsible Person (RP) established in the EU. For Chinese manufacturers, this is typically a French or EU-based regulatory consultant. RP services cost EUR 500 to EUR 2,000 per year per brand, plus per-product fees.

2. Cosmetic Product Safety Report (CPSR)

Before any product is placed on the market, a qualified safety assessor must sign a CPSR consisting of:

• Part A: Cosmetic Product Safety Information, including composition, physico-chemical data, microbiological quality, impurities, and exposure data.
• Part B: Cosmetic Product Safety Assessment, with the assessor’s conclusion, warnings, and rationale.

CPSR costs typically range from EUR 350 to EUR 900 per SKU, depending on complexity.

3. Good Manufacturing Practice (ISO 22716)

The product must be manufactured in a facility certified to ISO 22716 cosmetics GMP. When sourcing from China, verify the factory’s ISO 22716 certificate is current and covers the relevant product category. Aromiso maintains ISO 22716 certification for its cosmetic-grade production lines.

4. CPNP Notification

Before launch, the product must be notified through the Cosmetic Products Notification Portal (CPNP). The notification includes the RP details, product category, frame formulation, original label, and a photograph of the packaging. Notification is free but mandatory, and French authorities (ANSM) cross-check it during market surveillance.

5. Product Information File (PIF)

The RP must maintain a PIF for 10 years after the last batch is placed on the market. The PIF includes the CPSR, manufacturing description, GMP evidence, claims substantiation, and animal testing declarations.

6. Ingredient Restrictions and Annexes

Regulation 1223/2009 includes:

• Annex II: Prohibited substances (more than 1,600 entries).
• Annex III: Restricted substances, including many fragrance allergens and certain preservatives.
• Annex IV to VI: Allowed colorants, preservatives, and UV filters.

Fragrance ingredients must comply with both IFRA Standards and Annex III restrictions, which sometimes differ.

7. Allergen Labeling

The original 26 fragrance allergens must be declared on the INCI list when present above 0.001 percent in leave-on products or 0.01 percent in rinse-off products. The EU Omnibus Act, adopted in 2023 and phasing in from 2026, expands this list to more than 80 allergens, with a transition period until July 2026 for new products and July 2028 for existing products.

French-Specific Enforcement

France enforces 1223/2009 through:

• ANSM (Agence nationale de securite du medicament et des produits de sante): market surveillance, recalls, and inspections.
• DGCCRF (Direction generale de la concurrence, de la consommation et de la repression des fraudes): labeling, claims, and consumer protection.

Penalties for non-compliance can reach EUR 1.5 million and 2 years imprisonment for serious infringements, and ANSM regularly publishes recall notices. French selective retailers such as Sephora, Marionnaud, and Galeries Lafayette require full PIF access before listing.

Cost of Compliance for a Fragrance Cosmetic Line

For a 5-SKU body mist or roll-on launch:

• CPSR: EUR 350 to EUR 900 per SKU, totaling EUR 1,750 to EUR 4,500.
• ISO 22716 audit verification: usually covered by the factory.
• RP services: EUR 800 to EUR 2,000 per year.
• CPNP notification: free, but preparation costs EUR 100 to EUR 250 per SKU.
• Stability and challenge testing: EUR 400 to EUR 900 per SKU.
• French-language label review: EUR 150 to EUR 400 per SKU.

Total compliance budget: roughly EUR 5,000 to EUR 12,000 for a 5-SKU program.

Practical Workflow

1. Confirm the product is a cosmetic, not a biocide or consumer product.
2. Select an ISO 22716-certified factory.
3. Develop the formulation with IFRA and Annex III compliance.
4. Run stability and preservative challenge testing.
5. Compile the CPSR with a qualified EU safety assessor.
6. Appoint an EU Responsible Person.
7. Notify via CPNP before the first shipment.
8. Maintain the PIF for 10 years.

Final Thoughts

EU 1223/2009 is demanding but predictable. Buyers who treat the CPSR, ISO 22716 verification, and CPNP notification as core development steps, rather than last-minute hurdles, launch faster and avoid the ANSM enforcement actions that affect under-prepared competitors. Aromiso supports French cosmetic fragrance brands with ISO 22716-certified production, IFRA-compliant formulations, and full CPSR-ready documentation, making China sourcing fully compatible with French regulatory expectations.