Sell Cosmetics in Belgium: Regulatory Compliance Guide

• FPS Health (Federal Public Service Health) is the designated competent authority for cosmetics in Belgium under Regulation (EC) 1223/2009.
• Labels must include all mandatory elements in three official languages: French, Dutch, and German.
• Serious undesirable effects are reported to FPS Health; FAMHP has a complementary market surveillance role.

1. The EU framework applies — notify once, sell everywhere

Belgium applies Regulation (EC) 1223/2009 directly — the harmonised rules that govern cosmetic products across the entire European Union. There is no parallel national regime: the safety, composition, and labelling rules are the same as in the rest of the EU.

In practice, selling in Belgium within the EU framework means meeting four common obligations that are not specific to this country:

• A single CPNP notification covers the entire EU market, including Belgium.
• A single EU-established Responsible Person is accountable for the product.
• A single product information file (PIF), which includes the cosmetic product safety report (CPSR).

This guide does not repeat that common framework — it focuses on what is specific to Belgium. For the cross-cutting concepts, see also what the CosIng database is and how to use it.

2. The national competent authority

The designated national competent authority is the Service Public Fédéral Santé publique, Sécurité de la Chaîne alimentaire et Environnement (in Dutch: Federale Overheidsdienst Volksgezondheid), known as FPS Health. Its website is health.belgium.be. The Directorate-General for Control and Mediation (DG Inspection) within FPS Health carries out market surveillance and enforcement.

The FAMHP (Federal Agency for Medicines and Health Products) has a complementary role: it jointly manages serious undesirable effect (SUE) reporting with FPS Health and participates in market surveillance. FAMHP is the authority for medicines and medical devices; its involvement in cosmetics is secondary but operationally real. Sciensano, the Belgian public health institute, provides laboratory analytical services for cosmetics at the request of the authorities.

For a brand entering the Belgian market, the practical starting point is health.belgium.be, where FPS Health publishes guidance on product categories, labelling requirements, and reporting obligations. SUE reports are directed to cosmetovig@health.fgov.be — a dedicated channel that reflects Belgium's commitment to post-market safety monitoring.

3. Labelling language requirements

Under FPS Health guidance, cosmetic product labels in Belgium must include all mandatory Article 19 elements in all three official languages: French (FR), Dutch (NL), and German (DE). This applies to: product function, ingredient list, precautions for use, nominal content, durability date, and manufacturer details. Omitting any of the three languages is treated as a compliance violation under market surveillance practice.

As a practical alternative for packaging with limited space, FPS Health accepts multilingual labelling solutions or QR codes linking to approved online translations.

Practical implication for packaging design: The three-language requirement means that Belgian packaging typically requires significantly more label space than single-language markets. Brands launching in Belgium often use accordion labels, separate language stickers, or digital labelling solutions. The critical point is that all mandatory Article 19 elements — not just selected ones — must appear in each of the three languages; partial multilingual coverage is not compliant.

INCI ingredient names are exempt from the language requirement, as they are internationally standardised nomenclature.

4. National particularities

Three-language labelling: the defining Belgium requirement

The requirement to include label elements in all three official languages is Belgium's most operationally significant national specificity. For international brands, this typically means designing packaging with sufficient space for French, Dutch, and German text — or using a multi-label or peel-off label solution that allows the full required text in each language without compromising readability.

Serious undesirable effect reporting

Serious undesirable effects (SUEs) must be reported to FPS Health immediately at: cosmetovig@health.fgov.be. FAMHP is also involved in this reporting process.

Sciensano analytical testing

Sciensano, Belgium's national public health institute, can be called upon by FPS Health or FAMHP to carry out laboratory testing of cosmetic products in the context of market surveillance. While Sciensano does not regulate products directly, a positive enforcement finding from Sciensano laboratory analysis can result in regulatory action by FPS Health or FAMHP. This reinforces the importance of maintaining a robust product information file (PIF) with a complete and accurate cosmetic product safety report (CPSR).

The three authorities — FPS Health, FAMHP, and Sciensano — operate in a coordinated framework: FPS Health leads on regulatory oversight and market access, FAMHP contributes to adverse effect surveillance and joint enforcement, and Sciensano provides independent laboratory analysis capacity. For companies entering the Belgian market, this means that enforcement action can be initiated from multiple angles, and full compliance documentation is the essential safeguard.

No pre-market authorisation

There is no pre-market authorisation requirement. Belgium, like the rest of the EU, operates a post-market surveillance model. CPNP notification is sufficient for market access. For verifying ingredient compliance against the Regulation's annexes, the CosIng database is the standard reference.

For other markets in the region, see our guides to the Netherlands, Austria, Ireland, Luxembourg, and Portugal.

5. Frequently asked questions

Which authority regulates cosmetics in Belgium? The FPS Health (Service Public Fédéral Santé publique / Federale Overheidsdienst Volksgezondheid — Federal Public Service Health) is the designated national competent authority. FAMHP plays a complementary role in serious undesirable effect reporting and market surveillance.

What language must cosmetic labels be in for Belgium? Under FPS Health guidance, cosmetic product labels must include all mandatory elements in all three official languages: French (FR), Dutch (NL), and German (DE). Omitting any of the three is a compliance violation.

Do I need a separate notification for Belgium? No. A single CPNP notification covers the entire EU market, including Belgium. There is no additional national registration layer.

Are there national particularities beyond Regulation 1223/2009? Yes. Three-language labelling (FR/NL/DE) is the most significant Belgium-specific requirement. Additionally, serious undesirable effects must be reported to FPS Health (cosmetovig@health.fgov.be), and Sciensano may test products at the request of the authorities. There is no additional national notification beyond CPNP — a single EU-level notification is sufficient for market access.