If you want to sell cosmetics in Spain, the product rules are the EU ones; the Spanish layer covers the language of the label and the product file, a declaration for companies that manufacture or import, and packaging producer duties. In short: complete the EU product file, put the required label items in Spanish, check whether you must file a declaration with the AEMPS, and register as a packaging producer where the Spanish packaging decree applies to you. This guide is for brands that comply, or plan to comply, with Regulation (EC) No 1223/2009. It is general information, not legal advice.
Contents
- The short answer
- The EU baseline in brief
- Who supervises cosmetics in Spain?
- Which label items must be in Spanish?
- The product file and documents in Spanish
- Declaration for manufacturers and importers
- Packaging: producer registration and EPR
- What do Spanish retailers and marketplaces expect?
- Common mistakes when selling in Spain
- Checklist: ready to sell in Spain
- Frequently asked questions
- Key takeaways
The short answer
Spain applies the EU Cosmetics Regulation directly and supplements it with Royal Decree 85/2018, which regulates cosmetic products. The Spanish Agency for Medicines and Health Products (AEMPS) is the first competent authority named in the decree. Four Spanish points matter most to a foreign or new brand: Spanish on certain label items, Spanish for the product file kept in Spain, a pre-start declaration for manufacturers and non-EU importers, and the packaging rules in Royal Decree 1055/2022. We read the decree on the official BOE site and the AEMPS guidance directly; points we could not confirm are marked.
The EU baseline in brief
These building blocks are the same in every Member State, so the recap is short:
- Responsible person (RP): a person established in the EU who answers for compliance; name and address are on the label.
- Safety assessment: a qualified assessor signs a CPSR (Part A and Part B) before the product is placed on the market.
- Product information file (PIF): the dossier behind the CPSR, kept for ten years after the last batch is placed on the market, with stability, microbiological and challenge test reports where relevant.
- CPNP notification: filed on the European portal before launch.
- Labelling: the Article 19 information, with the language of certain items set by each Member State.
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Who supervises cosmetics in Spain?
Article 5 of Royal Decree 85/2018 names the AEMPS first among the Spanish competent authorities for cosmetics, acting under the powers set out in its statute. The decree names further authorities alongside it, so the office that contacts you can differ from one case to another. The AEMPS publishes a public register of manufacturers and importers, receives declarations through an online application, can ask for supporting documents and can start an inspection.
Expect any request to focus on the label, the CPNP reference, the CPSR and the PIF contents. A serious undesirable effect linked to your product must be notified to the competent authority, so keep a contact on the label that can act quickly.
Which label items must be in Spanish?
Article 19(5) of the Regulation leaves the language of certain label items to each Member State. In Spain, Article 6 of Royal Decree 85/2018, headed language of labelling and of the information file, requires Spanish for the items in Article 19(1) points (b), (c), (d) and (f) and Article 19(2), (3) and (4) on products made available to end users in Spain. In plain terms:
- the nominal content,
- the date of minimum durability or the period after opening,
- the precautions for use and warnings, including those from the Annexes,
- the function of the product, unless clear from its presentation,
- the information that paragraphs 2 to 4 allow on a leaflet, tag or insert when the pack is too small.
The decree applies the same logic, in its Article 7, to cosmetics sold unpackaged, packed at the point of sale or pre-packed for immediate sale. The text we reviewed names Spanish only. Adding Catalan, Galician, Basque or Valencian is not mentioned, so treat it as an optional extra and confirm with your assessor. The ingredient list uses INCI names and is not a language item.
The product file and documents in Spanish
Spain has an explicit rule for the file. According to the decree, the product information file kept in Spanish territory must be in Spanish. Specialised scientific documentation, such as technical test reports, may be in French or English, although Spanish can be required if doubts arise during the evaluation. For documents the authority requests from responsible persons and distributors, Spanish is the rule, but the authority may accept other languages that are easily understood.
In practice, ask your assessor which parts of the file to prepare in Spanish, and keep lab reports such as microbiological data in their original language if the authority accepts it. Where the file must be held depends on where the RP is established.
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Declaration for manufacturers and importers
Chapter VI of the decree sets a declaration procedure that applies before the activity starts. According to the AEMPS questions and answers, it applies to companies that carry out manufacturing, conditioning, packaging or labelling of cosmetics in Spain and to importers of cosmetics from non-EU countries. Companies that subcontract all production, even if they own the brand, are not required to file. The declaration is submitted through the AEMPS application, the agency allows 10 business days to correct missing data and 15 business days to supply documents it requests, and the declaration can be voided if requirements are not met.
Edge cases, such as distributors that only translate or change labels, differ between versions of the guidance, so read the current AEMPS FAQ for your set-up.
Packaging: producer registration and EPR
Royal Decree 1055/2022 on packaging and packaging waste applies to every product sold in packaging, including cosmetics. In summary:
- The “producer of product” is the packer or the business that imports or acquires packaged goods from other EU Member States. If a distributor brand has no identified producer, the brand owner based in Spain acts as the producer.
- Producers register in the packaging section of the Registro de Productores de Producto and report annually on the packaging they place on the market.
- Extended producer responsibility is met either individually or through a collective system.
- Online platforms selling packaged goods from outside Spain can act as subsidiary producer when the seller has not appointed an authorised representative.
- Household packaging should indicate the fraction or bin where it belongs, and wording such as “environmentally friendly” on packaging is prohibited.
The Spanish ministry has also published a note on how the EU packaging regulation (EU) 2025/40 interacts with the producer definition, so check the current ministry page before you register.
What do Spanish retailers and marketplaces expect?
Pharmacies, parapharmacies, perfumeries, department stores and marketplaces typically ask for the RP details, the CPNP reference, a Spanish-language label or pack photo and the safety report summary. For claims on tolerance or sensitive skin they may also want a patch test. These requests come from each buyer’s policy rather than the law, so treat them as a pattern.
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Common mistakes when selling in Spain
- Printing warnings or the function only in English.
- Assuming that an English-only PIF will be accepted without asking the authority.
- Skipping the AEMPS declaration while manufacturing, packing or labelling in Spain.
- Appointing a responsible person outside the EU.
Checklist: ready to sell in Spain
- Responsible person in the EU named on the label.
- Signed CPSR and complete PIF with finished-product test reports.
- CPNP notification submitted.
- Nominal content, durability or PAO, precautions, function and instructions in Spanish.
- Spanish version of the file summary ready for the authority.
- AEMPS declaration checked for manufacturing, packing, labelling or non-EU import.
- Packaging producer registration and EPR route settled.
- Document folder ready for authorities and buyers.
Frequently asked questions
Can I sell in Spain with an English-only label?
Not if the product reaches end users in Spain. The items listed in Article 6 of Royal Decree 85/2018 must be in Spanish. Bilingual or multilingual labels are a common solution.
Do I need a Spanish responsible person?
No. The responsible person must be established in the EU, not necessarily in Spain. Their name and address must be on the label.
Does the AEMPS declaration replace the CPNP notification?
No. The declaration concerns the activity of manufacturing or importing. The CPNP notification, safety report and product file belong to each product and remain separate duties.
Key takeaways
- The AEMPS is the lead authority under Royal Decree 85/2018.
- Spanish is required for key label items, and for the product file kept in Spain.
- Manufacturers, packers and non-EU importers may need to file a declaration before starting.
- Packaging producers register and report under Royal Decree 1055/2022.