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 national competent authority for cosmetics in Spain under Regulation (EC) 1223/2009 (official text) — Spain is the EU's fourth-largest cosmetics market at €11.21 billion in 2024.
• Under Royal Decree 85/2018 (BOE-A-2018-2693), Spanish is mandatory for the listed label elements and for a PIF kept in Spain (specialised scientific documentation in English or French may be accepted); INCI ingredient names are exempt.
• Those who physically manufacture, package or label cosmetics in Spain, and importers from third countries, must submit a responsible declaration to AEMPS before starting activity. Personal care products, a separate national category that is not cosmetics, need a prior AEMPS authorisation under the second additional provision of Royal Decree 1599/1997.

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

Spain applies Regulation (EC) 1223/2009 (official text) 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. Two labelling points are left by the Regulation to national law: the language of the label (Article 19(5)) and the rules for products that are not pre-packaged or are packaged at the point of sale (Article 19(4)), which Spain sets in Articles 6 and 7 of Royal Decree 85/2018.

In practice, selling in Spain within the EU framework means meeting three 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 national competent authority for cosmetics in Spain. Its name references medicines because its wider remit covers drugs and medical devices too — but it is also the national authority for cosmetics. Official cosmetics URL: www.aemps.gob.es/cosmeticos. What the agency publishes on cosmetics — withdrawal notes, a quarterly bulletin, the annual cosmetovigilance and market surveillance reports — and on what calendar, is covered in AEMPS and cosmetics: what Spain's regulator publishes.

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 shared. Article 5 of Royal Decree 85/2018 lists four competent authorities: AEMPS; the Inspección Farmacéutica of the Government Delegations and Subdelegations, which inspects to check responsible declarations of manufacturing and import and carries out border health inspections of imported cosmetics; the autonomous community health authorities, which carry out inspections and controls within their competences; and the local health authorities, within theirs. This means a company may receive inspections from more than one administrative level.

3. Labelling language requirements

Spanish is mandatory for specific cosmetic label elements in Spain. The legal basis is Article 6 of Royal Decree 85/2018 (BOE-A-2018-2693), which, for products made available to the end user in Spain, requires in Spanish the information in Article 19(1)(b), (c), (d) and (f) and 19(2), (3) and (4) of Regulation (EC) 1223/2009: nominal content, minimum durability date or PAO, precautions for use, and product function, plus the related information in paragraphs 2 to 4.

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.

Ingredient-level restrictions apply uniformly across the EU: substances subject to concentration limits under Annex III of the Regulation are restricted in Spain exactly as in the rest of the single market. To check whether a specific ingredient is subject to these limits, you can search the CosIng database directly.

PIF in Spanish: Royal Decree 85/2018 requires that the information in the product information file (PIF) be in Spanish when the PIF is kept in Spain. Specialised scientific documentation in English or French may be accepted, but if there are doubts in assessing it, its presentation in Spanish can be required.

4. National particularities

Responsible declaration to AEMPS

Under Article 18 of Royal Decree 85/2018, anyone who in Spain physically manufactures, packages or labels cosmetics, and anyone who 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). Article 18.3 exempts exactly four cases:

• distributors of cosmetics already placed on the EU market that translate the labelling or modify it to name themselves as the responsible person;
• companies or facilities subcontracted by manufacturers and importers for storage or control;
• pharmacies that make cosmetics exclusively for sale in their own premises;
• establishments that split, for sale to the public, bulk cosmetics intended for that purpose by their manufacturer, such as colognes and solid soaps.

Personal care products: a separate national category

Spain also has personal care products (productos de cuidado personal), a national category that exists only in Spain. Article 2.m of Royal Legislative Decree 1/2015 defines them as substances or mixtures that, without being medicines, medical devices, cosmetics or biocides, are applied to the skin, teeth or mucous membranes for hygiene or aesthetic purposes, or to eliminate ectoparasites. They are not cosmetics, and Regulation (EC) 1223/2009 does not cover them.

The second additional provision of Royal Decree 1599/1997 gives a non-exhaustive list of examples: toothpastes, mouthwashes and tooth whiteners that cannot be considered cosmetics, chewing gums or tablets for oral hygiene and high-fluoride products for professional use; tattoo inks, micropigments and preparations for permanent and semi-permanent make-up, chemical skin-abrasion masks and transdermal patches; head-lice products; vaginal moisturisers; anal cleansers for haemorrhoids; sports massage products; and nasal and eye cleansers. AEMPS applies that provision to personal care products and requires a prior marketing authorisation from it for each product. We cover the regime, and the company declaration that goes with it, in PCP_DR: AEMPS moves personal care filings online.

Shared enforcement

Spain's territorial structure spreads inspection across several levels: AEMPS acts nationally, the Inspección Farmacéutica of the Government Delegations and Subdelegations checks responsible declarations and inspects imports at the border, and the autonomous community and local health authorities inspect and control within their competences. Companies operating in multiple regions may receive inspections from more than one administrative level.

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 Cosmetics Europe Market Performance 2024 (June 2025), retail sales of cosmetic and personal care products reached €11.21 billion, placing Spain fourth in the EU. Spain is also 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 national competent authority for cosmetics in Spain. Despite "Medicamentos" in its name, it covers cosmetics. Royal Decree 85/2018 also names as competent authorities the Inspección Farmacéutica of the Government Delegations and Subdelegations, the health authorities of the autonomous communities and the local health authorities, each within its own remit.

What language must cosmetic labels be in for Spain? Under Royal Decree 85/2018 (BOE-A-2018-2693), Spanish is mandatory for the label information in Article 19(1)(b), (c), (d) and (f) and 19(2), (3) and (4) of Regulation (EC) 1223/2009 for products made available to the end user in Spain. A PIF kept in Spain must also be in Spanish; specialised scientific documentation in English or French may be accepted, but Spanish can be required if there are doubts in assessing it.

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 when the PIF is kept in Spain. Separately, Spain has personal care products, a national category of products that are not cosmetics (Royal Legislative Decree 1/2015, Art. 2.m): toothpastes outside the cosmetic scope, tattoo and permanent make-up inks, chemical skin-abrasion masks, head-lice products, vaginal moisturisers and others. AEMPS requires a prior marketing authorisation for them under the second additional provision of Royal Decree 1599/1997. Enforcement is shared between AEMPS, the Inspección Farmacéutica, the autonomous communities and local authorities.