AEMPS and cosmetics: what Spain's regulator publishes

• AEMPS is the Spanish state agency, attached to the Ministry of Health, that acts as Spain's competent authority for cosmetic products: it evaluates, inspects, withdraws products from the market and runs cosmetovigilance.
• It does not write cosmetics law — that is Regulation (EC) 1223/2009 — but it applies it in Spain through Royal Decree 85/2018 and the Medicines Guarantees Act (RDL 1/2015), which also creates a category that exists only in Spain: personal care products.
• It publishes on a recognisable calendar: safety notes on withdrawals almost every month, a quarterly bulletin, the annual cosmetovigilance report (March/April) and, since 2026, an annual market surveillance report (June). This guide links every official source.

Quotations from Spanish legislation and AEMPS documents are our own translation; the links point to the Spanish originals.

1. What is AEMPS and who does it report to?

The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) — the Spanish Agency for Medicines and Medical Devices — describes itself as a state agency attached to the Ministry of Health. The name undersells it: besides medicines and medical devices, it holds direct powers over cosmetics, personal care products and biocides.

Its legal basis is Royal Decree 1275/2011, which creates the agency and approves its Statute. Article 1.2 gives it its own legal personality, separate from the State, with its own assets and treasury. Article 7 — the list of functions — is where cosmetics appear explicitly:

• 7.29 — assess the health suitability and regulatory conformity of cosmetics, personal hygiene products and biocides for clinical and personal use;
• 7.32 — run the Spanish vigilance systems for medical devices and cosmetics, acting as the national reference centre;
• 7.33 — carry out inspection and control of medical devices, cosmetics and personal hygiene products;
• 7.23 — inspection and control programmes in coordination with the autonomous communities.

That last point matters. In Spain the cosmetics authority is not a single body: AEMPS sits at the top, but it shares market surveillance with the autonomous communities (Spain's regions) and local administrations, as the next section shows.

2. Does AEMPS regulate cosmetics? Which rules it applies

Yes, with one nuance worth getting right: AEMPS does not write European cosmetics law, it applies it. The substantive rule is Regulation (EC) 1223/2009, directly applicable in every Member State — our complete guide to Regulation 1223/2009 covers its structure. Article 22 of the Regulation requires Member States to monitor compliance through in-market controls, and Article 34.1 requires them to designate their national competent authorities. AEMPS is Spain's, and it is listed as such in the European Commission's list of competent authorities and poison centres.

On top of that, Spain applies three national rules. If what you need is the full route into the Spanish market — PIF in Spanish, labelling, responsible declaration — it is in our guide Sell cosmetics in Spain; here we focus on the agency and on what it publishes.

Royal Decree 85/2018: the complementary rules

Royal Decree 85/2018 of 23 February on cosmetic products exists, per its Article 1, to lay down "the complementary rules for the application of Regulation (EC) No 1223/2009". It is the text that lands the EU Regulation inside the Spanish administration. Its key articles:

The Guarantees Act (RDL 1/2015): penalties, fees and precautionary measures

Royal Legislative Decree 1/2015, the consolidated text of the Act on guarantees and rational use of medicines and medical devices, brings within its scope (Article 1.d) "cosmetics and personal care products and, in particular, the precautionary measures and the infringement and penalty regime applicable to them". From it come:

• the legal definition of a cosmetic product (Art. 2.n);
• the precautionary measures of Article 109, which include the "withdrawal from the market and recall of those products";
• the catalogue of infringements concerning cosmetics and personal care products (Art. 113);
• the fees for AEMPS services (Arts. 119–125);
• and the third additional provision, which places the manufacture and import of cosmetics under a responsible-declaration regime filed with AEMPS.

Personal care products: the category that exists only in Spain

This is the detail that most confuses anyone arriving from another EU country. Article 2.m of RDL 1/2015 defines personal care products (productos de cuidado personal) as substances or mixtures that, "without having the legal status of medicines, medical devices, cosmetics or biocides, are intended to be applied to the skin, teeth or mucous membranes" for hygiene or aesthetic purposes, "or to neutralise or eliminate ectoparasites".

It is a national category with no equivalent in Regulation 1223/2009, and it works differently from cosmetics: under Article 113.3.a, marketing them "without the mandatory health authorisation" is an infringement. In other words, a personal care product needs prior authorisation, whereas a cosmetic is not authorised but notified. Its specific regulation is still pending: the repeal provision of RD 85/2018 keeps Royal Decree 1599/1997 in force for them "until the specific regulation of personal care products is adopted". AEMPS explains which articles of that older text still apply on its personal care products page.

3. What does AEMPS publish about cosmetics, and how often?

This is the question that genuinely deserves a guide, because the AEMPS website spreads cosmetics information across sections that are not obviously linked. The entry point is the cosmetics hub, with four branches: legislation, cosmetovigilance, market surveillance and bulletins and reports.

What it publishes, ordered by frequency:

Three of those rows deserve a closer look.

The annual cosmetovigilance report

It is the document the press quotes most and misreads most. The 2025 report, published on 13 April 2026 and announced with note COS, 08/2026, records 143 notifications received, of which 26 were rejected and 117 investigated, with 37 serious cases. The official headline was a 30% increase in investigated notifications.

To read it properly, keep the full series at hand: the reports listing runs from the 2020 report to the 2024 report, and the publication dates (5 March 2024 for 2023, 24 March 2025 for 2024, 13 April 2026 for 2025) tell you when to expect the next one. A year-on-year percentage on a base of roughly a hundred cases swings a lot; the trend is read across several years, not one.

The annual market surveillance report

This one is new. The first edition, covering 2025, was published on 4 June 2026 and quantifies inspection activity for the first time: 1,957 cases assessed, of which "only 69 cases required the adoption of measures", and 12 safety notes published on the website, "25% fewer than in 2024". It also carries the EU figure: in 2025 Safety Gate recorded 1,668 alerts related to cosmetic products, 11.1% more than in 2024. If you handle regulatory affairs for Spain, this document is the picture of what inspectors actually look at.

Market surveillance campaigns

The campaigns page lists the proactive, risk-based inspections AEMPS has run on a specific topic: microbiological control of cosmetic products (2024), detection of prohibited substances (2023), prohibited CMR substances (2022) — you can check the current status of any ingredient in the BD-API CosIng search, hydroalcoholic gels (2022), the sun protection factor of sunscreens, and products sold without pre-packaging (2019). It is the Spanish inspectorate's priority list, said out loud. If your product category is on it, you already know what they will ask for, starting with the product information file (PIF), which Article 11(3) of the Regulation requires you to keep readily accessible to the competent authority.

4. What is cosmetovigilance and how do you report an undesirable effect?

Cosmetovigilance is, in the words of Article 16.1 of RD 85/2018, "the activity aimed at collecting, evaluating and following up information on undesirable effects" of cosmetic products. AEMPS runs it as the national reference centre (Art. 7.32 of its Statute) and also acts as Spain's contact point in ICSMS, the EU system through which authorities share serious undesirable effects across Member States.

Who reports, and whether they are obliged to, depends on who you are:

The nuance that separates an accurate reading from an alarmist one: the law only obliges companies for serious effects. Non-serious effects can be reported but are not mandatory, which explains part of the annual report's composition. If you are the Responsible Person, Article 23 is one more of your duties; they are all in our Responsible Person checklist.

The single channel is NotificaCS, AEMPS's cosmetovigilance reporting portal, with separate access for companies, healthcare professionals and citizens. The cosmetovigilance page explains each profile.

5. How do you know whether a cosmetic has been withdrawn in Spain?

There is a navigation trap here. AEMPS has a cosmetics alerts page, but it does not list alerts: it explains what Safety Gate is — the European Union's rapid alert system for dangerous non-food products — and points to the safety notes. So you have two surfaces, one Spanish and one European:

1. The Spanish surface: the cosmetics and personal care safety notes. Every cessation of marketing, withdrawal or batch recall decided in Spain is published there, with its COS code and, usually, the affected batches. It is the primary source for the Spanish market.
2. The European surface: the Safety Gate alerts search, where the Commission and Member States publish notifications of dangerous products, filterable by product category and notifying country. It is where Spanish withdrawals that are communicated to the rest of the EU appear, and where you see those of the other 26 Member States. We have a complete guide to Safety Gate for cosmetics.

And a third thing that is not a withdrawals surface, although it is often mistaken for one: the CPNP. The Cosmetic Products Notification Portal is "managed directly by the European Commission", as AEMPS itself clarifies in its FAQ on Regulation 1223/2009. Under Article 13.1 of the Regulation, the responsible person notifies the Commission, not AEMPS; the agency accesses the CPNP as a competent authority, as poison centres do. Notifying in the CPNP is not "registering the product with AEMPS", and AEMPS does not publish what is in the CPNP. For the details, see our CPNP guide.

6. Do you have to register with AEMPS? The responsible declaration and fees

A cosmetic product is not registered with AEMPS. A company that manufactures or imports cosmetics, however, does have a prior obligation: the responsible declaration (declaración responsable) of Article 18.1 of RD 85/2018, backed by the third additional provision of RDL 1/2015. AEMPS's FAQ on the responsible declaration puts it plainly: the declaration must be filed with AEMPS before the activity starts.

How it works in practice:

• It is filed through AEMPS's electronic office, procedure COSMET2_DR, with identification via Cl@ve or a digital certificate.
• Anyone can check whether a company has filed one in the public register of declared companies. It is a useful check before contracting a manufacturer or an importer.
• It carries a fee. According to the AEMPS fee schedule (table updated 28 June 2023), the verification and control of the responsible declaration for manufacturing cosmetics and personal care products (item 5.05) costs €932.46, and for importing (5.06) €466.23. The table lists others, such as certification (5.04, €173.04) or the cosmetics GMP inspection (5.16, €837.18).

The legal basis for those fees is Article 119.1 of RDL 1/2015, which creates the AEMPS "fee for the provision of services" concerning medicines, cosmetic products and personal care products.

Personal care products have their own circuit: the same company-level responsible declaration, but filed since 15 September 2026 in the PCP_DR application (until then it was a Word form), plus a prior authorisation for each product. We explain it in PCP_DR: AEMPS moves personal care filings online.

7. How BD-API handles this

Let us be clear about one thing: BD-API does not monitor AEMPS publications today. What we do is watch the European sources where national actions end up landing. A withdrawal decided in Spain and communicated to the rest of the EU appears in Safety Gate, and Safety Gate is one of the sources BD-API follows continuously, alongside SCCS, EUR-Lex, ECHA, IFRA and ePing. Each source and its cadence is described on our Regulatory Watch page.

That covers the European layer. For the strictly Spanish layer — what is published on the AEMPS website — the guide you have just read is, for now, your best tool: the safety notes, the quarterly bulletin and the two annual reports, at the official URLs above. And we are preparing something more: a bulletin with the measures published by national authorities — AEMPS and its EU counterparts — that do not always reach Safety Gate. If you want it when it is out, leave your email here. How to build the full circuit, with European and national sources, is covered in how to monitor EU cosmetic regulation changes.

8. Frequently asked questions

What is AEMPS? The Agencia Española de Medicamentos y Productos Sanitarios, a state agency attached to Spain's Ministry of Health, created by Royal Decree 1275/2011. Besides medicines and medical devices, it is Spain's competent authority for cosmetics, personal care products and biocides.

Does AEMPS regulate cosmetics? It applies the regulation rather than writing it. Cosmetics law is Regulation (EC) 1223/2009, directly applicable across the EU. AEMPS is the competent authority designated by Spain under its Article 34, and Royal Decree 85/2018 lays down the complementary rules for applying it in Spain.

Do you have to register a cosmetic with AEMPS? No. Cosmetic products are notified in the CPNP, the EU portal run by the Commission. What is filed with AEMPS is the responsible declaration of the manufacturing or importing company, before the activity starts.

What is cosmetovigilance? The collection, evaluation and follow-up of information on undesirable effects of cosmetics (Art. 16 of RD 85/2018). In Spain it runs through AEMPS's NotificaCS portal. Companies are only obliged to report serious effects, and immediately.

What is a personal care product in Spain? A category that exists only in Spanish law (Art. 2.m of RDL 1/2015): substances or mixtures that are not medicines, medical devices, cosmetics or biocides, intended for application to the skin, teeth or mucous membranes for hygiene or aesthetic purposes, or to neutralise or eliminate ectoparasites. Unlike cosmetics, they require prior health authorisation and remain governed by the articles of Royal Decree 1599/1997 that are still in force for this category.

Where can I see cosmetics withdrawals in Spain? In AEMPS's listing of cosmetics and personal care safety notes, where each withdrawal carries a "COS, NN/YYYY" code. The AEMPS alerts page does not list alerts; it points to Safety Gate, where the EU notifications appear.

How much does the responsible declaration cost? According to the AEMPS fee schedule (June 2023 table), €932.46 for the manufacturing activity and €466.23 for importing. It is filed through the electronic office, procedure COSMET2_DR.

When is the annual cosmetovigilance report published? Between March and April of the following year: the 2023 report came out on 5 March 2024, the 2024 report on 24 March 2025 and the 2025 report on 13 April 2026.

What is the difference between the cosmetovigilance report and the market surveillance report? The first counts reported undesirable effects (143 received and 117 investigated in 2025). The second, published for the first time in June 2026, counts inspection activity (1,957 cases assessed and 69 with measures in 2025). One measures what happens to users; the other, what the inspectorate does.

9. In short

AEMPS is not a distant agency that only matters to pharmaceutical companies. It is the authority that can pull your cosmetic off the Spanish market, the one that handles undesirable-effect reports and the one that receives your responsible declaration before you manufacture or import the first batch. Its information is all public, but scattered: safety notes, a quarterly bulletin, the annual cosmetovigilance report in spring, the market surveillance report in June and a campaigns page that announces where inspectors will look next.

What lands in Safety Gate, BD-API watches for you. What stays on the AEMPS website, you now at least know where it is and how often it changes — and, if you want, we will tell you about it in the bulletin.