Cosmetic compliance in Spain follows Regulation (EC) No 1223/2009 like everywhere else in the EU, but Spain layers on a national framework that is stricter than most in two specific places: the language of your documentation, and the requirement for certain manufacturers and importers to hold a national operating authorisation from AEMPS.
Spain is one of the EU’s largest cosmetics markets and a major exporter, and its competent authority — the Spanish Agency of Medicines and Medical Devices — is an active one. This guide sets out what you need before your first shipment: language rules that catch out almost every foreign brand, the AEMPS authorisation question, notification, and the enforcement landscape you are entering.
Key takeaways
- AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) is the competent authority; Royal Decree 85/2018 is the national implementing framework.
- Mandatory label information must be in Spanish — product function, warnings, precautions and directions for use.
- Spain uniquely requires the PIF to be held in Spanish, with only specialised scientific documentation permitted in English or French.
- Manufacturers and importers established in Spain need prior AEMPS operating authorisation — a national requirement with no equivalent in most Member States.
- Product notification is the standard EU CPNP route; there is no separate Spanish product registry.
- Spain is developing inclusive labelling requirements (Braille and tactile hazard markers), not yet finalised or dated.
- The EU anti-greenwashing rules under Directive (EU) 2024/825 apply in Spain from 27 September 2026.
AEMPS and the Spanish framework
The Agencia Española de Medicamentos y Productos Sanitarios is the national competent authority for cosmetics as well as medicines and medical devices. It decides borderline classification questions, receives cosmetovigilance reports, issues safety alerts, and — importantly — grants the national operating authorisations discussed below.
The national framework is Real Decreto 85/2018 of 23 February 2018, which regulates cosmetic products in Spain and complements the EU Regulation. Enforcement is shared: AEMPS handles national coordination and alerts, while the Autonomous Communities carry out inspections of establishments and market surveillance in their territory. That regional dimension matters — an inspection in Catalonia is conducted by the Generalitat’s health authority, not by AEMPS directly.
AEMPS publishes safety alerts and product withdrawals publicly, and it is worth monitoring: it is one of the more visible EU authorities for cosmetic enforcement actions, particularly around unauthorised claims, prohibited substances and products presented as borderline medicinal.
AEMPS is also the body that determines whether a product is a cosmetic at all. If your product sits near the medicine, medical device or biocide boundary, a Spanish classification decision can differ from the view taken elsewhere in the EU. Our guide to borderline product classification covers the criteria applied.
The requirement most brands miss: Spanish-language documentation
Every Member State can set the language of the label. Spain goes further and sets the language of the file.
The label
Article 19 information must appear in Spanish (Castilian). In practice that means:
| Label element | Language in Spain |
|---|---|
| Product function | Spanish required (unless clear from presentation) |
| Precautions and warnings | Spanish required |
| Directions for use | Spanish required |
| Ingredient list (INCI) | INCI nomenclature — not translated |
| Nominal content | Metric units |
| Durability date / PAO | Symbol-based; accompanying text in Spanish |
| RP name and address | As registered |
| Batch number | As assigned |
| Country of origin | Required for non-EU imports |
Multilingual packs are permitted and common — Spanish alongside Portuguese, French and Italian is a standard southern-Europe artwork. Spanish simply has to be there.
The Product Information File
This is the genuinely distinctive Spanish requirement. The PIF held by the Responsible Person for products on the Spanish market must be in Spanish, with only specialised scientific documentation permitted to remain in English or French.
The practical reading is that the parts an inspector needs to navigate — the product description, the manufacturing method and GMP statement, the CPSR conclusion and reasoning, the claim substantiation summaries — should be available in Spanish, while raw material toxicological dossiers, test reports and scientific literature may stay in their original language.
This does not mean translating thousands of pages. It means having a Spanish-language layer over your file: a translated CPSR Part B conclusion and safety assessor reasoning, a Spanish product description and manufacturing summary, and Spanish claim substantiation summaries. Building the PIF with this in mind from the start is far cheaper than retrofitting it under inspection pressure. See our PIF preparation guide for the file structure.
The PIF must be readily accessible in electronic or other format at the address of the Responsible Person indicated on the label, and produced to the competent authority on request. An inspector who asks for it and is told the file is with a consultant in another country, in English, and will take two weeks to assemble, has already found a compliance failure independent of anything in the formula.
The AEMPS operating authorisation
Under Royal Decree 85/2018, companies that manufacture or import cosmetic products and are established in Spain require prior operating authorisation from AEMPS before beginning activity. This is a facility and company-level licence, not a product registration, and it has no direct equivalent in most other Member States.
The authorisation covers the establishment, its technical facilities, and the qualified technical director responsible for the activity. Manufacturers must comply with GMP to ISO 22716. Applications go through AEMPS with supporting documentation on premises, equipment, processes and personnel, and are subject to inspection.
Two practical points for foreign brands:
If you manufacture in Spain — very common given the density of contract manufacturers in Catalonia, Valencia and Madrid — confirm in writing that your manufacturer holds a current AEMPS authorisation. It is their obligation, but a product made in an unauthorised facility is your problem.
If you import through a Spanish entity, that entity may need authorisation. Note the distinction from the EU Responsible Person role: an RP established elsewhere in the EU covers Spain for Cosmetic Regulation purposes without needing a Spanish licence. It is the Spanish-established importing or manufacturing company that triggers the national authorisation requirement.
If you sell into Spain from another EU country with an EU Responsible Person outside Spain and no Spanish establishment of your own, you generally do not need an AEMPS operating authorisation. Your obligations are the EU set plus Spanish language requirements. Structure matters here, so map your supply chain before assuming either way.
Notification and the standard EU file
Notification is unremarkable: the Responsible Person notifies through the CPNP before placing the product on the market, selecting Spain among the countries of placing on the market so the Spanish poison information service receives the frame formulation. There is no separate national registry. Our step-by-step CPNP submission guide covers the process, and common CPNP mistakes covers what goes wrong.
Everything else in the EU file applies unchanged: a CPSR signed by a qualified safety assessor, a complete PIF, GMP evidence, claim substantiation, and an EU-established Responsible Person named on the pack.
Cosmetovigilance in Spain
Article 23 of the Cosmetic Regulation requires the Responsible Person to notify serious undesirable effects to the competent authority of the Member State where they occurred. In Spain that is AEMPS, and reports go through its cosmetovigilance channel.
AEMPS operates an active alert system and publishes withdrawals. Two categories dominate: products containing prohibited substances (often from non-EU supply chains), and products making medicinal claims. If you receive a consumer complaint in Spain that meets the seriousness threshold, the clock starts immediately — build the reporting route into your RP arrangements before you need it, not after.
What is coming: inclusive labelling and green claims
Inclusive labelling
Spain has been developing requirements for inclusive labelling of cosmetic products, aimed at accessibility for blind and partially sighted consumers. Proposals under discussion include mandatory Braille on packaging and tactile markers identifying hazards, with essential information in clear Spanish text. As of now, no final text has been approved and no implementation date has been set — but it is a live file and worth tracking if you are planning artwork for multi-year print runs.
Green claims from 27 September 2026
Directive (EU) 2024/825 applies across the EU, Spain included, from 27 September 2026. Generic environmental claims without recognised excellent environmental performance are prohibited, product-level carbon neutrality claims based on offsetting are banned, and self-created sustainability labels not backed by a certification scheme are not permitted. Enforcement in Spain runs through consumer protection authorities at national and regional level.
As elsewhere, there is no grandfathering clause, so stock already in the Spanish channel is in scope. Our guide to the new green claims rules sets out what to remove, what to keep and how to substantiate it.
Bringing it all together
Spain rewards preparation. The product-level requirements are the standard EU set, so if your CPSR, PIF and CPNP notification are in order you are most of the way there. What is distinctly Spanish is documentation language and company authorisation — a Spanish-language label, a PIF whose navigable layer is in Spanish, and an AEMPS operating authorisation if you manufacture or import through a Spanish establishment.
The mistake that costs money is treating Spain as a translation exercise for the carton alone. Build the Spanish layer into the PIF from the outset, confirm your manufacturer’s authorisation status in writing, and settle whether the Spanish leg of your supply chain triggers the national licence. Do that and Spain is a large, accessible market with a clear regulator.
Lexora acts as EU Responsible Person and prepares complete compliance files for brands entering Spain and the wider EU market. Start with the Full Compliance Pack, or have your Spanish artwork checked with a cosmetic label review before your first print run.
Frequently asked questions
Does my Product Information File really have to be in Spanish?
For products on the Spanish market, yes — Spain requires the PIF to be held in Spanish, with only specialised scientific documentation permitted in English or French. In practice this means a Spanish-language layer over the file: product description, manufacturing and GMP summary, the CPSR conclusion and safety assessor reasoning, and claim substantiation summaries. Raw material dossiers and test reports can stay in their original language.
Do I need an AEMPS authorisation to sell cosmetics in Spain?
Only if you manufacture or import cosmetics through an establishment based in Spain. That triggers a prior operating authorisation under Royal Decree 85/2018, covering the facility, its technical director and ISO 22716 GMP compliance. If you sell into Spain from another EU country with an EU Responsible Person established elsewhere in the Union, the national authorisation generally does not apply to you.
Is there a separate Spanish product registration?
No. Product notification is the standard EU CPNP route, with Spain selected among the countries of placing on the market so the Spanish poison information service receives the frame formulation. There is no additional national product registry for cosmetics.
Can my label be multilingual?
Yes. Spanish must be present for the mandatory consumer-facing elements — function, warnings, precautions and directions for use — but other languages can appear alongside it. Spanish, Portuguese, French and Italian on one carton is a common and fully compliant southern-Europe artwork. The INCI list stays in INCI nomenclature throughout.
Who inspects cosmetic companies in Spain?
AEMPS is the national competent authority and handles alerts, classification and authorisations, but routine establishment inspections and market surveillance are carried out by the health authorities of the Autonomous Communities. An inspection is therefore likely to come from your regional authority rather than from AEMPS directly.
Is Braille labelling mandatory in Spain yet?
Not yet. Spain has been working on inclusive labelling requirements that would include Braille and tactile hazard markers, but no final text has been approved and no implementation date has been set. Treat it as a development to monitor rather than a current obligation, particularly if you are committing to long print runs.
Where must the PIF physically be kept?
It must be readily accessible in electronic or other format at the address of the Responsible Person shown on the label, and produced to the competent authority on request. The RP address can be anywhere in the EU, so the file does not have to sit in Spain — but it must be retrievable quickly and, for the Spanish market, in Spanish for the navigable sections.
