Who can be the EU Responsible Person for cosmetics?

A legal or natural person established in the EU. For imported products the importer is the Responsible Person by default, unless it appoints another EU-based person in writing.

The Cosmetic Products Notification Portal is the European Commission's online system where the Responsible Person notifies each cosmetic product before it is placed on the EU market. One notification covers all EU member states.

Do I need a declaración responsable to import cosmetics into Spain?

Yes, if your company imports cosmetics into Spain from countries outside the EU. The AEMPS requires the declaration before the activity starts, and imported goods must be consigned to a company that has filed it.

Which label information must be in Spanish?

Royal Decree 85/2018 requires the nominal content, the durability date, precautions for use and the product's function, among other items, to appear in Spanish on products made available to consumers in Spain.

Does an EU notification also cover the UK?

No. Great Britain has its own notification service (SCPN) and needs a UK-based Responsible Person. Northern Ireland follows the EU rules.

Selling Cosmetics in the EU & Spain: CPNP, PIF, RP

The EU Cosmetics Regulation (EC) No 1223/2009 applies in every EU country, so one compliance file and one notification let you sell across the single market. Spain adds national rules on language and on importing. This guide covers both, for brands that source their products from China.

The EU Responsible Person

Every cosmetic product placed on the EU market needs a Responsible Person (RP) established in the EU. For products made outside the EU, the importer is the RP by default; it can appoint another EU-based company in writing, such as a specialist RP service. The RP’s name and address must appear on the label.

The RP guarantees that the product complies: it is safe, it has a safety report and a Product Information File, it is notified, it is correctly labelled, and its claims are justified.

Safety report and Product Information File (PIF)

A qualified safety assessor must prepare a Cosmetic Product Safety Report (Annex I of the Regulation). Part A collects the data – formula, physical and chemical characteristics, stability, microbiological quality, impurities, packaging, exposure and toxicological profiles of the ingredients. Part B is the assessor’s conclusion.

The PIF combines the safety report with a product description, a description of the manufacturing method and a statement of compliance with good manufacturing practice, and proof of the claimed effects. The RP keeps it for ten years after the last batch is placed on the market, at the address on the label.

Your OEM supplier provides much of the raw data. Ask early for the full INCI formula with percentages, raw material documentation, and stability and compatibility information so your assessor is not waiting on you.

CPNP notification

Before placing the product on the market, the RP notifies it on the Cosmetic Products Notification Portal (CPNP). The notification includes the category and name, the RP’s details, the country of origin, the member state where it is first placed on the market, frame or exact formulation, nanomaterials, CMR substances and the original label. One CPNP notification covers the whole EU.

Spain’s extra requirements

Spanish-language labelling

Royal Decree 85/2018 (Article 6) requires certain label information to appear in Spanish for products made available to end users in Spain – including the nominal content, the durability date, precautions for use and the function of the product. Many brands print bilingual or multilingual packs, or add a compliant Spanish sticker before sale.

Declaración responsable for importers

Companies that import cosmetics into Spain from outside the EU must file a declaración responsable with the AEMPS (Spanish Agency of Medicines and Medical Devices) before starting the activity, using its online application. According to the AEMPS, imported cosmetics must be consigned to a company that has filed the declaration, and a brand owner that outsources all production is exempt only if it does not also import. Plan this before your first shipment – see importing cosmetics from China to Spain.

Ingredient rules change often

The EU regularly amends the annexes that ban or restrict substances. Recent examples include concentration limits for retinol, alpha-arbutin and kojic acid, the ban of the UV filter 4-MBC, an expanded list of fragrance allergens that must be labelled, and the restriction of intentionally added microplastics. We cover each in our Industry Updates: retinol, arbutin and kojic acid, fragrance allergen labelling and microplastics.

EU and Spain launch checklist

Decide who is the EU Responsible Person.
If your company imports into Spain, file the declaración responsable with the AEMPS.
Collect formula and test data from your supplier; commission the safety report.
Build the PIF at the RP’s address.
Design compliant labels, including Spanish where required – see label requirements.
Notify on the CPNP before sale.
Keep the PIF updated and report serious undesirable effects.

How Cosmebatch helps

We produce to your approved sample and specification, apply only branding you own, and help you collect the product information your RP and safety assessor need. With an MOQ of 144 pieces per product, you can notify and launch a small range first and grow from there. New to private label? Start with how to start your own skincare line.

Sources

EUR-Lex – Regulation (EC) No 1223/2009 on cosmetic products
European Commission – Cosmetic Products Notification Portal (CPNP)
BOE – Real Decreto 85/2018 on cosmetic products
AEMPS – FAQ on the declaración responsable

This guide is general information, not legal advice. Check the official sources or a regulatory consultant before you sell.