Sell Cosmetics in Spain: AEMPS, Royal Decree 85/2018 and Responsible Declaration

• AEMPS (Agencia Española de Medicamentos y Productos Sanitarios — Spanish Agency for Medicines and Health Products) is the competent authority for cosmetics in Spain under Regulation (EC) 1223/2009 — Spain is the EU's fourth-largest cosmetics market at €11.21 billion in 2024.
• Spanish is mandatory for labelling elements and the PIF under Royal Decree 85/2018 (BOE-A-2018-2693); INCI ingredient names are exempt.
• Manufacturers and importers must submit a responsible declaration to AEMPS before starting activity; certain personal care products require pre-market authorisation.

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

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

2. The national competent authority

The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS — Spanish Agency for Medicines and Health Products) is the competent authority for cosmetics in Spain. Its name references medicines because its wider remit covers drugs and medical devices too — but AEMPS has full regulatory and market surveillance competence for cosmetics. Official cosmetics URL: www.aemps.gob.es/cosmeticos.

AEMPS functions for cosmetics include: processing responsible declarations, market surveillance, cosmetovigilance, good manufacturing practice (GMP) inspections, cosmetic/drug boundary classification, and issuance of free sale certificates.

Enforcement in Spain is dual-layer: AEMPS acts at national level, and the autonomous community health authorities exercise their own inspection and sanctioning powers within their respective territories. This means a company may receive inspections from both administrative levels.

3. Labelling language requirements

Spanish is mandatory for cosmetic label elements in Spain. The legal basis is Royal Decree 85/2018 (BOE-A-2018-2693), which specifies elements that must appear in Spanish: nominal content, minimum durability date or PAO, precautions for use, and product function.

Spain is a multilingual country. Products sold in Catalonia, the Basque Country, or other regions with co-official languages are not required by national cosmetics law to include those languages — Spanish is sufficient for national regulatory compliance. Additional regional language requirements are not established by Royal Decree 85/2018.

INCI ingredient names are exempt from the language requirement. For ingredient identification in the CosIng database, INCI nomenclature requires no Spanish translation.

PIF in Spanish: Royal Decree 85/2018 requires that the product information file (PIF) held by the Responsible Person in Spain be in Spanish. Exception: specialised scientific documentation may be in English or French. This is one of the strictest PIF language requirements in the EU.

4. National particularities

Responsible declaration to AEMPS

Any entity that in Spain manufactures, packages, cosmetically labels, or imports cosmetics from third countries must submit a responsible declaration (declaración responsable) to AEMPS before starting activity. The process is handled through the portal: sinaem.aemps.es/COSMET2/Declaracion/Login. Applicable fees vary by activity type (manufacturing or importing). Exemptions include distributors of products already on the EU market, pure subcontractors, and storage-only operators, among others.

Personal care products requiring pre-market authorisation

Spain maintains a pre-market authorisation regime for certain products that sit at the boundary between cosmetics and regulated products. This regime applies to: tattoo inks, permanent makeup, chemical peels, vaginal lubricants, and specific types of toothpaste with particular claims. These products require AEMPS authorisation before being placed on the market — an additional step not required in most other EU member states.

Dual AEMPS/autonomous community enforcement

Spain's territorial structure creates a two-tier inspection system: AEMPS coordinates nationally and the autonomous community health authorities can inspect and sanction within their territories. Companies operating in multiple regions may receive inspections from both administrative levels.

For other markets in the region, see our guides to Germany, France, Italy, and Poland.

5. Market context

Spain is the fourth-largest cosmetics market in the European Union. According to the Cosmetics Europe Annual Report 2024 (published June 2025), retail sales of cosmetic and personal care products reached €11.21 billion, placing Spain fourth in the EU. The Spanish market is particularly strong in perfumery and hair care, and is a strategic entry point for brands targeting Latin American markets due to linguistic and cultural affinity.

The Spanish-language PIF requirement and the responsible declaration to AEMPS are the aspects that most frequently require additional attention from companies already operating in other EU markets when entering Spain.

6. Frequently asked questions

Which authority regulates cosmetics in Spain? The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS — Spanish Agency for Medicines and Health Products) is the competent authority for cosmetics in Spain. Despite "Medicamentos" in its name, AEMPS has full national competence for cosmetics, alongside the health authorities of Spain's autonomous communities within their respective territories.

What language must cosmetic labels be in for Spain? Spanish is mandatory for the label elements specified in Royal Decree 85/2018 (BOE-A-2018-2693). The PIF must also be in Spanish, with the exception of specialised scientific documentation, which may be in English or French.

Do I need a separate notification for Spain? No separate CPNP notification is needed — one notification covers the entire EU. However, any entity that manufactures, packages, labels, or imports cosmetics from third countries in Spain must submit a responsible declaration (declaración responsable) to AEMPS before starting activity, via sinaem.aemps.es.

Are there national particularities beyond Regulation 1223/2009? Yes. Royal Decree 85/2018 requires a responsible declaration to AEMPS before starting activity and a Spanish-language PIF. It also establishes a pre-market authorisation regime for certain personal care products (tattoo inks, permanent makeup, chemical peels, vaginal lubricants and others). The dual AEMPS/autonomous community enforcement structure is also distinctive.