Sell Cosmetics in Portugal: Regulatory Compliance Guide

• INFARMED, I.P. is the sole competent authority for cosmetics in Portugal under Regulation (EC) 1223/2009 and Decreto-Lei 23/2025.
• Portuguese is mandatory for all consumer-facing label elements (DL 23/2025, in force 24 March 2025).
• DL 23/2025 introduces an INFARMED activity registration and an import declaration for products from third countries — two Portugal-specific obligations not present in most other EU member states.

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

Portugal 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 Portugal 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 Portugal.
• 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 Portugal. For the cross-cutting concepts, see also what the CosIng database is and how to use it.

2. The national competent authority

The sole competent authority is INFARMED, I.P. — Autoridade Nacional do Medicamento e dos Produtos de Saúde (National Authority for Medicines and Health Products). Its cosmetics reference page is infarmed.pt/web/infarmed-en/cosmetics. For compliance and import queries, the contact is pchc@infarmed.pt.

Although the INFARMED name references "medicines", it is the full and exclusive competent authority for cosmetic products in Portugal. INFARMED's role covers market surveillance, the activity registration system introduced by Decreto-Lei 23/2025, the import declaration process for third-country products, and enforcement of the penalty regime. ASAE (Autoridade de Segurança Alimentar e Económica — Authority for Food and Economic Safety) is a separate authority that has no jurisdiction over cosmetics — a common source of confusion for operators familiar with food-adjacent regulatory systems.

3. Labelling language requirements

Portuguese is mandatory for all consumer-facing label elements. The legal basis is Decreto-Lei 23/2025 (in force since 24 March 2025), which replaces Decreto-Lei 189/2008 and aligns the Portuguese framework with Regulation 1223/2009.

Elements that must appear in Portuguese include: nominal content, minimum durability date or period after opening (PAO), precautions for use, product function, and usage instructions.

The mandatory Portuguese labelling requirement is practically significant for international brands targeting the Portuguese market: products labelled exclusively in Spanish or another Romance language are not compliant. A dedicated Portuguese-language label or a multilingual label that clearly includes all mandatory elements in Portuguese is required.

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

4. National particularities

Decreto-Lei 23/2025: an active national framework

Portugal has one of the most active national frameworks for cosmetics in the EU. Decreto-Lei 23/2025, in force since 24 March 2025, establishes the following Portugal-specific obligations:

Activity registration with INFARMED: Manufacturers, importers, or entities making the first placement on the Portuguese market and established in Portugal must register their activity on INFARMED's electronic platform. The registration window is 180 days from the platform's launch. This is a Portugal-specific obligation not present in most other EU member states.

Import declaration: When importing cosmetics from third countries (outside the EU), the Portugal-established importer must submit to customs authorities a declaration issued by INFARMED certifying compliance with Regulation 1223/2009 and DL 23/2025. This declaration is requested from INFARMED via pchc@infarmed.pt; the evaluation period is 20 working days; there is no cost.

Serious undesirable effect reporting: Responsible Persons and distributors must report serious undesirable effects (SUEs) to INFARMED immediately.

Penalty regime: Serious violations carry fines of €500–€20,000; very serious violations carry fines of €2,500–€44,890.

Non-prepackaged cosmetics: DL 23/2025 includes specific rules for cosmetics sold unpackaged or prepared at the point of sale — a category that includes in-store blending, spa treatments, and similar services. Operators in this category should consult the DL 23/2025 text directly or seek specialist legal advice on which labelling and safety obligations apply to their specific business model.

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, Belgium, Austria, Ireland, and Luxembourg.

5. Frequently asked questions

Which authority regulates cosmetics in Portugal? INFARMED, I.P. (Autoridade Nacional do Medicamento e dos Produtos de Saúde — National Authority for Medicines and Health Products) is the sole competent authority for cosmetics in Portugal. ASAE (Autoridade de Segurança Alimentar e Económica) has no jurisdiction over cosmetics.

What language must cosmetic labels be in for Portugal? Portuguese is mandatory for all mandatory label elements under Decreto-Lei 23/2025, in force since 24 March 2025: nominal content, durability date, precautions for use, product function, and usage instructions. INCI ingredient names are exempt.

Do I need a separate notification for Portugal? CPNP notification covers the entire EU market, including Portugal. However, Decreto-Lei 23/2025 introduces an obligation for manufacturers, importers, or first distributors established in Portugal to register their activity on INFARMED's electronic platform within 180 days of the platform's launch.

Are there national particularities beyond Regulation 1223/2009? Yes. Portugal has an active national framework under Decreto-Lei 23/2025: activity registration with INFARMED, an import declaration for products from third countries (issued by INFARMED within 20 working days), and a penalty regime reaching €44,890 for very serious violations.