Saint Barthélemy is a French overseas collectivity and, although politically associated with France, it is not part of the European Union Customs Territory. However, it still generally follows French national regulations and accepts EU product compliance frameworks like CE marking, especially in sectors such as health, telecom, and consumer goods.

Key Authorities:

• Préfecture de Saint-Barthélemy et Saint-Martin – Oversees administration and coordination with French regulatory bodies.

• French Directorate-General for Competition, Consumer Affairs, and Fraud Control (DGCCRF) – Monitors market surveillance, consumer protection, and product safety.

• Agence Nationale de Sécurité du Médicament (ANSM) – Regulates pharmaceuticals, medical devices, and health products, under French jurisdiction.

• ARCEP France – Responsible for telecom equipment regulation, including RF compliance and network standards.

• French Customs – Enforces documentation, import duties, and verification of conformity where applicable.

Key Compliance Elements:

• Accepted Standards:

  • Saint Barthélemy accepts products that comply with:

    • French national laws and EU regulations (including CE marking)

    • International norms such as ISO, Codex, and IEC

    • U.S. standards (e.g., FCC) are sometimes accepted for informal trade, but not officially recognized in regulated sectors

• Product Registration:

  • Required for:

    • Medicines and vaccines (via ANSM or EMA)

    • Medical devices and diagnostics

    • Cosmetics and dietary supplements

  • Products registered or approved for the French or EU market are accepted without additional local procedures.

• Telecom Equipment:

  • Devices must comply with the EU Radio Equipment Directive (RED) and bear the CE mark.

  • There is no local type approval beyond what is already enforced in France.

  • ARCEP manages spectrum and licensing compliance, if applicable.

• Labeling Requirements:

  • Labels must be in French, and include:

    • Product name

    • Manufacturer/importer contact

    • Country of origin

    • Usage instructions and safety warnings

    • CE mark (if applicable)

    • Expiry/batch number (for regulated items)

• Import Oversight:

  • Even though Saint Barthélemy is outside the EU Customs Union, French customs law applies.

  • Imports must include:

    • Invoice and packing list

    • CE or French conformity documentation

    • Product registration (if applicable)

    • Certificate of origin

    • Customs declaration through French systems

• Market Surveillance:

Handled by French regulatory agencies under the DGCCRF, with support from local prefecture officials. Inspections target health products, electronics, and food safety.