Importing cosmetics from China into the European Union

1. Applicable legal framework

The reference rule is Regulation (EC) No 1223/2009 on cosmetic products, directly applicable across the EU. It is not a prior-authorisation regime: there is no register that “approves” a product before it is sold, but a set of obligations that must be met before placing it on the market.

• It applies to every cosmetic product marketed in the EU, regardless of where it is manufactured.
• The importer who places the product on the EU market under its own name or brand takes on the most demanding obligations in the chain.
• Non-compliance can lead to withdrawal from the market, detention at customs and administrative penalties.

2. Responsible Person established in the EU

Every cosmetic product must have a designated Responsible Person established in the European Union. Without one the product cannot be placed on the market, and their name and address must appear on the label.

• If you import from China and no EU manufacturer or distributor takes on that role, the Responsible Person will be your company as importer.
• The designation must be made in writing and accepted by the designated party.
• The Responsible Person guarantees compliance with the regulation, keeps the product file and answers to the enforcement authorities.
• A Chinese supplier cannot be the Responsible Person: they must be established in the EU.

3. CPNP notification

Before placing the product on the market, the Responsible Person must notify it through the European CPNP portal (Cosmetic Products Notification Portal). It is an electronic notification, not an authorisation.

• Notified data includes the product category and name, the Responsible Person, the country of importation, the frame formulation and the labelling.
• Products containing nanomaterials may also be subject to the specific notification requirements of Article 16 of Regulation (EC) No 1223/2009, in addition to the general notification under Article 13.
• CPNP information is made available to poison control centres and competent authorities.
• The notification must be kept up to date whenever the formula, the packaging or the Responsible Person changes.

4. The role of AEMPS in Spain

In Spain the competent authority for cosmetic products is the Spanish Agency of Medicines and Medical Devices (AEMPS). Understanding its role avoids starting from the wrong expectations.

• AEMPS does not authorise or register products one by one: there is no “AEMPS approval” before a cosmetic can be sold.
• It carries out market surveillance, inspection and cosmetovigilance, and takes action when a product is not compliant.
• Pre-market notification is made through the European CPNP portal, not to AEMPS: CPNP is the EU-level notification of the product.
• Companies carrying out the commercial import of cosmetic products coming directly from third countries into Spain must submit to AEMPS the responsible declaration of import activities (declaración responsable de actividades de importación) before starting that activity. This declaration is a Spanish requirement concerning the importer's activity, distinct from the CPNP notification of the product.
• This requirement relates to the activity of importing from a third country. The situation may be different when the product has already been lawfully placed on the European Union market by another operator and is subsequently distributed in Spain.

5. Health control at the border

Cosmetics coming from countries outside the European Union are subject in Spain to health control at the border carried out by the Pharmaceutical Inspection services.

• Depending on the operation, the control may include documentary checks, identity checks and/or physical checks of the goods.
• These controls are processed through SIFAEX, the information system of the Pharmaceutical Inspection of External Health (Sistema Informático de Inspección Farmacéutica de Sanidad Exterior).
• Documentation and regulatory compliance must be ready before the goods reach the border: an incident at this stage can prevent clearance and entry of the product.

• AEMPS — Border controls
• AEMPS — SIFAEX

6. Product information file and safety assessment

Each product needs a Product Information File (PIF) that the Responsible Person must keep accessible to the authorities for ten years from the date the last batch was placed on the market.

• The PIF includes the product description, the safety report, a description of the manufacturing method, proof of the claimed effect where relevant and data on animal testing.
• The safety report consists of the product safety information and the assessment signed by a person holding the qualification required by the regulation.
• The address of the Responsible Person shown on the label is the address where the file must be available.
• Ask your Chinese supplier for the full technical data sheet, the quantitative formula, certificates of analysis and specifications for raw materials and packaging: without them a PIF cannot be completed.

7. Good manufacturing practice

The regulation requires manufacturing to follow good manufacturing practice. Compliance is presumed when manufacturing follows the applicable harmonised standards, currently referenced as ISO 22716.

• ISO 22716 is a good manufacturing practice standard specific to cosmetics, not a product certification.
• A valid ISO 22716 certificate from the manufacturer is a solid indicator, but it does not replace process verification or a plant audit.
• Do not confuse ISO 22716 with ISO 9001: the latter is a general-purpose quality management system.
• Check that the certificate covers the plant actually manufacturing your product and the product category you contracted.

8. Composition: restricted and prohibited substances

The regulation includes annexes listing prohibited and restricted substances, as well as permitted colorants, preservatives and UV filters. Those lists are updated frequently by subsequent regulations.

• Check the full formula against the current version of the annexes before confirming a production order.
• Differences between Chinese and European rules are common for preservatives and sunscreen filters: a product that is legal in China may not be legal in the EU.
• Nanomaterials carry specific notification obligations and must be indicated in the ingredient list.
• Agree in writing with the manufacturer that the formula is produced to the approved European specification, batch after batch.
• CosIng, the European Commission's cosmetic ingredient database, is a useful reference tool. Its content is informative: the legal status of each substance must be checked against Regulation (EC) No 1223/2009 and its annexes in force.

• CosIng — European Commission

9. Fragrance allergens on the label

Regulated fragrance allergens must be listed individually in the ingredient list when they exceed the established thresholds: 0.001% in leave-on products and 0.01% in rinse-off products.

• The list of fragrance allergens subject to individual declaration has been extended by later legislation, with transition periods to adapt products and labels.
• Always work from the list in force at the time you print the labelling and confirm the transition periods that apply to your product.
• Ask your fragrance supplier for an allergen certificate with the actual percentages in the finished product, not only in the concentrate.
• Changing fragrance supplier means the allergen declaration has to be reviewed again.

10. Labelling and language

Labelling is one of the most frequent reasons an imported batch is rejected. Many mandatory particulars must appear in the language of the country where the product is marketed.

• Mandatory particulars: name and address of the Responsible Person, country of origin for imported products, nominal content, date of minimum durability or period after opening, precautions for use, batch number, product function and ingredient list.
• In Spain, the particulars the regulation leaves to the language determined by the Member State must appear in Spanish; these include precautions for use and the product function.
• The ingredient list uses INCI nomenclature and is not translated.
• Bilingual or multi-country labelling is workable, but it must be validated country by country before printing.

11. Animal testing ban

The EU bans both animal testing of cosmetic products and ingredients and the marketing of cosmetics whose safety has been demonstrated through animal tests carried out for those purposes.

• The ban also applies to products manufactured outside the EU and imported for marketing.
• The safety assessment must rely on alternative methods and on admissible pre-existing data.
• There is an ongoing debate about how this ban interacts with testing required by other legislation, such as chemicals rules; review the current position with your adviser before closing the documentation.
• China has relaxed its animal testing requirements in recent years for certain imported general cosmetics, but that does not exempt you from the European regime: the burden of proof is yours.

12. Customs, classification and costs

Regulatory and customs compliance run in parallel on every import. A compliant product can still be held up by an incorrect tariff classification or incomplete paperwork.

• Classify the product correctly in TARIC and check the measures applicable to Chinese origin.
• Prepare commercial and transport documentation consistent with the declaration: invoice, packing list, transport document and, where applicable, certificates.
• Budget duty, import VAT, clearance, inland transport and the cost of adapting the labelling from the outset.
• Allow time and budget for relabelling on arrival if the supplier cannot print the final European labelling.

13. What we do and do not do at EC HolaHome

We work with companies importing cosmetics from China and support the industrial and purchasing side of the project. It is important to be clear about where our scope ends.

• We do: factory search and assessment, product and packaging development, negotiation, production follow-up, quality control and inspection, logistics coordination and document collection from the supplier.
• We do not act as Responsible Person for your products, nor do we take on that legal role.
• We do not issue safety assessments or file CPNP notifications on your behalf as a regulatory service.
• We do not provide legal or regulatory advice: we coordinate with the Responsible Person, the safety assessor and the customs representative you appoint.